Anticipatory planning and control of grasp positions and forces for dexterous two-digit manipulation.

PubMed

Fu, Qiushi; Zhang, Wei; Santello, Marco

2010-07-07

Dexterous object manipulation requires anticipatory control of digit positions and forces. Despite extensive studies on sensorimotor learning of digit forces, how humans learn to coordinate digit positions and forces has never been addressed. Furthermore, the functional role of anticipatory modulation of digit placement to object properties remains to be investigated. We addressed these questions by asking human subjects (12 females, 12 males) to grasp and lift an inverted T-shaped object using precision grip at constrained or self-chosen locations. The task requirement was to minimize object roll during lift. When digit position was not constrained, subjects could have implemented many equally valid digit position-force coordination patterns. However, choice of digit placement might also have resulted in large trial-to-trial variability of digit position, hence challenging the extent to which the CNS could have relied on sensorimotor memories for anticipatory control of digit forces. We hypothesized that subjects would modulate digit placement for optimal force distribution and digit forces as a function of variable digit positions. All subjects learned to minimize object roll within the first three trials, and the unconstrained device was associated with significantly smaller grip forces but larger variability of digit positions. Importantly, however, digit load force modulation compensated for position variability, thus ensuring consistent object roll minimization on each trial. This indicates that subjects learned object manipulation by integrating sensorimotor memories with sensory feedback about digit positions. These results are discussed in the context of motor equivalence and sensorimotor integration of grasp kinematics and kinetics.

Proactive and reactive control depends on emotional valence: a Stroop study with emotional expressions and words.

PubMed

Kar, Bhoomika Rastogi; Srinivasan, Narayanan; Nehabala, Yagyima; Nigam, Richa

2018-03-01

We examined proactive and reactive control effects in the context of task-relevant happy, sad, and angry facial expressions on a face-word Stroop task. Participants identified the emotion expressed by a face that contained a congruent or incongruent emotional word (happy/sad/angry). Proactive control effects were measured in terms of the reduction in Stroop interference (difference between incongruent and congruent trials) as a function of previous trial emotion and previous trial congruence. Reactive control effects were measured in terms of the reduction in Stroop interference as a function of current trial emotion and previous trial congruence. Previous trial negative emotions exert greater influence on proactive control than the positive emotion. Sad faces in the previous trial resulted in greater reduction in the Stroop interference for happy faces in the current trial. However, current trial angry faces showed stronger adaptation effects compared to happy faces. Thus, both proactive and reactive control mechanisms are dependent on emotional valence of task-relevant stimuli.

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

PubMed Central

2010-01-01

Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302 PMID:20334685

A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program.

PubMed

LaChausse, Robert G

2016-09-01

To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use.

Randomized Trial of Asprin as Adjuvant Therapy for Node-Positive Breast Cancer

DTIC Science & Technology

2017-10-01

Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704...penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR...TERMS Breast cancer, adjuvant treatment, aspirin, randomized controlled trial 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF

Therapeutic effects of antimicrobial treatment during lactation of recently acquired bovine subclinical mastitis: two linked randomized field trials.

PubMed

van den Borne, B H P; van Schaik, G; Lam, T J G M; Nielen, M

2010-01-01

Two linked randomized field trials were performed on 39 herds in the Netherlands to 1) determine therapeutic effects of antimicrobial treatment of recently acquired subclinical mastitis (RASCM) during lactation, 2) evaluate the effect of duration of subclinical mastitis on therapeutic outcome, and 3) identify factors related to the therapeutic success of RASCM. Cows with a first elevated composite somatic cell count (CSCC) after 2 consecutive low CSCC measurements were eligible for enrollment in trial 1 (treatment at the first elevated CSCC). Quarter milk samples were collected to determine bacteriological status for major pathogens and coagulase-negative staphylococci. Cows with one or more culture-positive quarters with a quarter somatic cell count (QSCC) >or=100,000 cells/mL were defined to have RASCM and were randomly assigned treatment or control (no treatment). Untreated cows from trial 1 that had a second elevated CSCC at the next milk recording were eligible for enrollment in trial 2 (treatment at the second elevated CSCC). In trial 2, staphylococci-positive cows (Staphylococcus aureus and coagulase-negative staphylococci) were randomly assigned to treatment or control. Farmers used their own treatment protocols to treat quarters in both trials. Bacteriological cure was defined as absence of the pathogen identified pre-intervention in 2 samples post-intervention; QSCC, CSCC, and milk yield were also analyzed. Hierarchical logistic and linear models were used to determine therapeutic effects and to identify factors related to therapy outcome. Treated quarters had a higher bacteriological cure rate than control quarters for all pathogens in both trials. Treatment resulted in lower QSCC and CSCC, whereas milk yield was not affected by treatment. Bacteriological cure of RASCM was better in quarters with a low QSCC pre-intervention and in coagulase-negative staphylococci-positive quarters. Control quarters with a single culture-positive sample pre-intervention also had a higher bacteriological cure than control quarters with >or=2 culture-positive samples. Time of antimicrobial treatment affected bacteriological cure for penicillin-sensitive Staph. aureus. Bacteriological cure tended to be higher for Staph. aureus after treatment at the first elevated CSCC compared with treatment at the second elevated CSCC. Thus, early treatment of Staph. aureus might be more effective than later treatment. Copyright 2010 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial.

PubMed

Bell, Lauren; Hooper, Richard; Bunce, Catey; Pasu, Saruban; Bainbridge, James

2017-06-13

The treatment of idiopathic full-thickness macular holes involves surgery to close the hole. Some surgeons advise patients to adopt a face-down position to increase the likelihood of successful macular hole closure. However, patients often find the face-down positioning arduous. There is a lack of conclusive evidence that face-down positioning improves the outcome. The 'Positioning In Macular hole Surgery' (PIMS) trial will assess whether advice to position face-down after surgery improves the surgical success rate for the closure of large (≥400 μm) macular holes. The PIMS trial is a multicentre, parallel-group, superiority clinical trial with 1:1 randomisation. Patients (n = 192) with macular holes (≥400 μm) will be randomised after surgery to either face-down positioning or face-forward positioning for at least 8 h (which can be either consecutive or nonconsecutive) a day, for 5 days following surgery. Inclusion criteria are: presence of an idiopathic full-thickness macular hole ≥400 μm in diameter, as measured by optical coherence tomography (OCT) scans, on either or both eyes; patients electing to have surgery for a macular hole, with or without simultaneous phacoemulsification and intraocular lens implant; ability and willingness to position face-down or in an inactive face-forward position; a history of visual loss suggesting a macular hole of 12 months' or less duration. The primary outcome is successful macular hole closure at 3 months post surgery. The treatment effect will be reported as an odds ratio with 95% confidence interval, adjusted for size of macular hole and phakic lens status at baseline. Secondary outcome measures at 3 months are: further surgery for macular holes performed or planned (of those with unsuccessful closure); patient-reported experience of positioning; whether patients report they would still have elected to have the operation given what they know at follow-up; best-corrected visual acuity (BCVA) measured using Snellen charts at a standard distance of 6 m; patient-reported health and quality of life assessed using the National Eye Institute Visual Function Questionnaire (VFQ-25). The PIMS trial is the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. International Standard Randomised Controlled Trials Number registry, ID: ISRCTN12410596. Registered on 11 February 2015. United Kingdom Clinical Research Network, ID: UKCRN17966 . Registered on 26 November 2014.

Association of industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

PubMed

Probst, Pascal; Grummich, Kathrin; Ulrich, Alexis; Büchler, Markus W; Knebel, Phillip; Diener, Markus K

2014-11-27

Industry sponsorship has been identified as a factor correlating with positive research findings in several fields of medical science. To date, the influence of industry sponsorship in general and abdominal surgery has not been fully studied. This protocol describes the rationale and planned conduct of a systematic review to determine the association between industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery. A literature search in the Cochrane Library, MEDLINE and EMBASE and additional hand searches in relevant citations will be conducted. In order to cover all relevant areas of general and abdominal surgery, a new literature search strategy called multi-PICO search strategy (MPSS) has been developed. No language restriction will be applied. The search will be limited to publications between January 1985 and July 2014. Information on funding source, outcome, study characteristics and methodological quality will be extracted.The association between industry sponsorship and positive outcome will be tested by a chi-squared test. A multivariate logistic regression analysis will be performed to control for possible confounders, such as number of study centres, multinational trials, methodological quality, journal impact factor and sample size. This study was designed to clarify whether industry-sponsored trials report more positive outcomes than non-industry trials. It will be the first study to evaluate this topic in general and abdominal surgery. The findings of this study will enable surgical societies, in particular, to give advice about cooperation with the industry and disclosure of funding source based on empirical evidence. PROSPERO CRD42014010802.

A Web-Based Adolescent Positive Psychology Program in Schools: Randomized Controlled Trial.

PubMed

Burckhardt, Rowan; Manicavasagar, Vijaya; Batterham, Philip J; Miller, Leonie M; Talbot, Elizabeth; Lum, Alistair

2015-07-28

Adolescent mental health is characterized by relatively high rates of psychiatric disorders and low levels of help-seeking behaviors. Existing mental health programs aimed at addressing these issues in adolescents have repeated inconsistent results. Such programs have generally been based on techniques derived from cognitive behavioral therapy, which may not be ideally suited to early intervention among adolescent samples. Positive psychology, which seeks to improve well-being rather than alleviate psychological symptoms, offers an alternative approach. A previous community study of adolescents found that informal engagement in an online positive psychology program for up to 6 weeks yielded significant improvements in both well-being and depression symptoms. However, this approach had not been trialed among adolescents in a structured format and within a school setting. This study examines the feasibility of an online school-based positive psychology program delivered in a structured format over a 6-week period utilizing a workbook to guide students through website content and interactive exercises. Students from four high schools were randomly allocated by classroom to either the positive psychology condition, "Bite Back", or the control condition. The Bite Back condition consisted of positive psychology exercises and information, while the control condition used a series of non-psychology entertainment websites. Both interventions were delivered online for 6 hours over a period of 4-6 weeks during class time. Symptom measures and measures of well-being/flourishing and life satisfaction were administered at baseline and post intervention. Data were analyzed using multilevel linear modeling. Both conditions demonstrated reductions in depression, stress, and total symptom scores without any significant differences between the two conditions. Both the Bite Back and control conditions also demonstrated significant improvements in life satisfaction scores post intervention. However, only the control condition demonstrated significant increases in flourishing scores post intervention. Results suggest that a structured online positive psychology program administered within the school curriculum was not effective when compared to the control condition. The limitations of online program delivery in school settings including logistic considerations are also relevant to the contradictory findings of this study. Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 (Archived by Webcite at http://www.webcitation.org/6NXmjwfAy).

"I didn't really understand it, I just thought it'd help": exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial.

PubMed

Harrop, Emily; Noble, Simon; Edwards, Michelle; Sivell, Stephanie; Moore, Barbara; Nelson, Annmarie

2016-07-20

Few studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. However, integrated qualitative studies in such trials are needed to enable a broader evaluation of patient experiences in the trial, with important ethical and practical implications for the design and conduct of similar trials and treatment regimes in the future. Ten participants were recruited from the control and intervention arms of FRAGMATIC: a non-placebo trial for patients with advanced lung cancer. Participants were interviewed at up to three time points during their time in the trial. Interviews were analysed using Interpretive Phenomenological Analysis. Patients were motivated to join the trial out of hope of medical benefit and altruism. Understanding of randomisation was mixed and in some cases poor, as was appreciation of trial purpose and equipoise. The trial was acceptable to and evaluated positively by most participants; participants receiving the intervention focused on the potential treatment benefits they hoped they would receive, whilst participants in the control arm found alternative reasons, such as altruism, personal fulfilment and positive attention, to commit to and perceive benefits from the trial. However, whilst experiences were generally very positive, poor understanding, limited engagement with trial information and focus on treatment benefits amongst some participants give cause for concern. By exploring longitudinally the psychological, emotional and cognitive domains of trial participation, we consider potential harms and benefits of participation in non-placebo trials amongst patients with advanced lung cancer and identify several implications for future research with and care for patients with advanced cancer. ISRCTN80812769 . Registered on 8 July 2005.

Maintenance of equilibrium point control during an unexpectedly loaded rapid limb movement.

PubMed

Simmons, R W; Richardson, C

1984-06-08

Two experiments investigated whether the equilibrium point hypothesis or the mass-spring model of motor control subserves positioning accuracy during spring loaded, rapid, bi-articulated movement. For intact preparations, the equilibrium point hypothesis predicts response accuracy to be determined by a mixture of afferent and efferent information, whereas the mass-spring model predicts positioning to be under a direct control system. Subjects completed a series of load-resisted training trials to a spatial target. The magnitude of a sustained spring load was unexpectedly increased on selected trials. Results indicated positioning accuracy and applied force varied with increases in load, which suggests that the original efferent commands are modified by afferent information during the movement as predicted by the equilibrium point hypothesis.

Results from the Trial Using Motivational Interviewing, Positive Affect, and Self-Affirmation in African Americans with Hypertension (TRIUMPH).

PubMed

Boutin-Foster, Carla; Offidani, Emanuela; Kanna, Balavenkatesh; Ogedegbe, Gbenga; Ravenell, Joseph; Scott, Ebony; Rodriguez, Anna; Ramos, Rosio; Michelen, Walid; Gerber, Linda M; Charlson, Mary

2016-01-21

Our objective was to determine the effectiveness of combining positive affect and self-affirmation strategies with motivational interviewing in achieving blood pressure control among hypertensive African Americans (AA) compared with AA hypertensives in an education-only control group. Randomized trial. Ambulatory practices in the South Bronx and Harlem, New York City. African American adults with uncontrolled hypertension. Participants were randomized to a positive affect and self-affirmation intervention or an education control group. The positive affect and self-affirmation intervention involved having participants think about things that made them happy and that reminded them of their core values on a daily basis. These strategies were reinforced every two months through motivational interviewing. The control arm received a workbook of strategies on blood pressure control. All participants were called every two months for one year. Blood pressure control rate. A total of 238 participants were randomized. The average age was 56 ± 11 years, approximately 70% were female, 80% were not married, and up to 70% had completed high school. There was no difference in control rates between the intervention and the control group. However, at one year, female participants were more likely to be controlled. Participants with high depressive symptoms or high perceived stress at baseline were less likely to be controlled. While this study did not demonstrate an intervention effect, it does provide important insight into the psychosocial factors that may underlie blood pressure control in African Americans. Implications for future behavioral intervention trials are discussed.

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

PubMed

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Positioning and spinal bracing for pain relief in metastatic spinal cord compression in adults.

PubMed

Lee, Siew Hwa; Grant, Robin; Kennedy, Catriona; Kilbride, Lynn

2015-09-24

This is an updated version of the original Cochrane review published in Issue 3 (Lee 2012) on patient positioning (mobilisation) and bracing for pain relief and spinal stability in adults with metastatic spinal cord compression.Many patients with metastatic spinal cord compression (MSCC) have spinal instability, but their clinician has determined that due to their advanced disease they are unsuitable for surgical internal fixation. Mobilising may be hazardous in the presence of spinal instability as further vertebral collapse can occur. Current guidance on positioning (whether a patient should be managed with bed rest or allowed to mobilise) and whether spinal bracing is helpful, is contradictory. To investigate the correct positioning and examine the effects of spinal bracing to relieve pain or to prevent further vertebral collapse in patients with MSCC. For this update, we searched for relevant studies from February 2012 to 31 March 2015. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In Process, EMBASE, AMED, CINAHL, TRIP, SIGN, NICE, UK Clinical Research Network, National Guideline Clearinghouse and PEDro database. We also searched the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov, UK Clinical Trials Gateway (UKCTG), WHO International Clinical Trials Registry Platform (ICTRP) and Australia New Zealand Clinical Trials Registry (ANZCTR).For the original version, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, CANCERLIT, NICE, SIGN, AMED, TRIP, National Guideline Clearinghouse, and PEDro database, in February 2012. We selected randomised controlled trials (RCTs) of adults with MSCC of interventions on positioning (mobilisation) and bracing. Two review authors independently assessed each possible study for inclusion and quality. For the original version of the review, we screened 1611 potentially relevant studies. No studies met the inclusion criteria. Many papers identified the importance of mobilisation, but no RCTs of bed rest versus mobilisation have been undertaken. We identified no RCTs of bracing in MSCC.For this update, we identified 347 potential titles. We screened 300 titles and abstracts after removal of duplicates. We did not identify any additional studies for inclusion. Since publication of the original version of this review, no new studies were found and our conclusions remain unchanged.There is a lack of evidence-based guidance around how to correctly position and when to mobilise patients with MSCC or if spinal bracing is an effective technique for reducing pain or improving quality of life. RCTs are required in this important area.

Trial of Propranolol in Children and Youth with ASD and Predictors of Response

DTIC Science & Technology

2017-07-01

youth) predicts treatment response. The design for both aims will be a double-blinded, placebo- controlled trial, 12 weeks in duration, with...the youth) predicts treatment response. The design for both aims will be a double-blinded, placebo- controlled trial, 12 weeks in duration, with...Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704

Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial

PubMed Central

Downing Jr, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

2016-01-01

Background Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results Participant recruitment began in June 2015 and ended in December 2015. Conclusions This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive![+] intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed. ClinicalTrial ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG) PMID:27315764

Review of Randomized Controlled Trials of Massage in Preterm Infants

PubMed Central

Niemi, Anna-Kaisa

2017-01-01

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. PMID:28368368

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial.

PubMed

Hughes-Morley, Adwoa; Hann, Mark; Fraser, Claire; Meade, Oonagh; Lovell, Karina; Young, Bridget; Roberts, Chris; Cree, Lindsey; More, Donna; O'Leary, Neil; Callaghan, Patrick; Waheed, Waquas; Bower, Peter

2016-12-08

Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants. This is a cluster trial, embedded within a host trial ('EQUIP') recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation. Thirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes. To our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research. ISRCTN, ISRCTN16488358 . Registered on 14 May 2014. Study Within A Trial, SWAT-26 . Registered on 21 January 2016.

No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial

PubMed Central

2011-01-01

Background The WHO advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position in which she feels most comfortable. It has been suggested that upright positions may improve childbirth outcomes and reduce the risk for instrumental delivery; however RCTs of interventions to encourage upright positions are scarce. The aim of this study was to test, by means of a randomized controlled trial, the hypothesis that the use of a birthing seat during the second stage of labor, for healthy nulliparous women, decreases the number of instrumentally assisted births and may thus counterbalance any increase in perineal trauma and blood loss. Methods A randomized controlled trial in Sweden where 1002 women were randomized to birth on a birth seat (experimental group) or birth in any other position (control group). Data were collected between November 2006 and July 2009. The primary outcome measurement was the number of instrumental deliveries. Secondary outcome measurements included perineal lacerations, perineal edema, maternal blood loss and hemoglobin. Analysis was by intention to treat. Results The main findings of this study were that birth on the birth seat did not reduce the number of instrumental vaginal births, there was an increase in blood loss between 500 ml and 1000 ml in women who gave birth on the seat but no increase in bleeding over 1000 ml and no increase in perineal lacerations or perineal edema. Conclusions The birth seat did not reduce the number of instrumental vaginal births. The study confirmed an increased blood loss 500 ml - 1000 ml but not over 1000 ml for women giving birth on the seat. Giving birth on a birth seat caused no adverse consequences for perineal outcomes and may even be protective against episiotomies. Trial registration number ClinicalTrials.gov.ID: NCT01182038 PMID:21435238

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.

An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families.

PubMed

Wilson, Dawn K; Kitzman-Ulrich, Heather; Resnicow, Ken; Van Horn, M Lee; St George, Sara M; Siceloff, E Rebekah; Alia, Kassandra A; McDaniel, Tyler; Heatley, VaShawn; Huffman, Lauren; Coulon, Sandra; Prinz, Ron

2015-05-01

The Families Improving Together (FIT) randomized controlled trial tests the efficacy of integrating cultural tailoring, positive parenting, and motivational strategies into a comprehensive curriculum for weight loss in African American adolescents. The overall goal of the FIT trial is to test the effects of an integrated intervention curriculum and the added effects of a tailored web-based intervention on reducing z-BMI in overweight African American adolescents. The FIT trial is a randomized group cohort design the will involve 520 African American families with an overweight adolescent between the ages of 11-16 years. The trial tests the efficacy of an 8-week face-to-face group randomized program comparing M + FWL (Motivational Plus Family Weight Loss) to a comprehensive health education program (CHE) and re-randomizes participants to either an 8-week on-line tailored intervention or control on-line program resulting in a 2 (M + FWL vs. CHE group) × 2 (on-line intervention vs. control on-line program) factorial design to test the effects of the intervention on reducing z-BMI at post-treatment and at 6-month follow-up. The interventions for this trial are based on a theoretical framework that is novel and integrates elements from cultural tailoring, Family Systems Theory, Self-Determination Theory and Social Cognitive Theory. The intervention targets positive parenting skills (parenting style, monitoring, communication); cultural values; teaching parents to increase youth motivation by encouraging youth to have input and choice (autonomy-support); and provides a framework for building skills and self-efficacy through developing weight loss action plans that target goal setting, monitoring, and positive feedback. Copyright © 2015. Published by Elsevier Inc.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

PubMed

Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

2016-02-01

The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

No negative priming without cognitive control.

PubMed

de Fockert, Jan W; Mizon, Guy A; D'Ubaldo, Mariangela

2010-12-01

There is evidence that the efficiency of selective attention depends on the availability of cognitive control mechanisms as distractor processing has been found to increase with high load on working memory or dual task coordination (Lavie, Hirst, de Fockert, & Viding, 2004). We tested the prediction that cognitive control load would also affect the negative priming effect produced when a distractor from 1 trial appears as a target on the next trial. We measured priming on trials that involved either high or low cognitive control load, and found that under high control load, negative priming was eliminated, and could even be reversed to positive priming, suggesting that the negative priming effect depends on the availability of cognitive control resources.

Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.

PubMed

Mayer-Hamblett, Nicole; Rosenfeld, Margaret; Treggiari, Miriam M; Konstan, Michael W; Retsch-Bogart, George; Morgan, Wayne; Wagener, Jeff; Gibson, Ronald L; Khan, Umer; Emerson, Julia; Thompson, Valeria; Elkin, Eric P; Ramsey, Bonnie W

2013-10-01

The Early Pseudomonal Infection Control (EPIC) randomized trial rigorously evaluated the efficacy of different antibiotic regimens for eradication of newly identified Pseudomonas (Pa) in children with cystic fibrosis (CF). Protocol based therapy in the trial was provided based on culture positivity independent of symptoms. It is unclear whether outcomes observed in the clinical trial were different than those that would have been observed with historical standard of care driven more heavily by respiratory symptoms than culture positivity alone. We hypothesized that the incidence of Pa recurrence and hospitalizations would be significantly reduced among trial participants as compared to historical controls whose standard of care preceded the widespread adoption of tobramycin inhalation solution (TIS) as initial eradication therapy at the time of new isolation of Pa. Eligibility criteria from the trial were used to derive historical controls from the Epidemiologic Study of CF (ESCF) who received standard of care treatment from 1995 to 1998, before widespread availability of TIS. Pa recurrence and hospitalization outcomes were assessed over a 15-month time period. As compared to 100% of the 304 trial participants, only 296/608 (49%) historical controls received antibiotics within an average of 20 weeks after new onset Pa. Pa recurrence occurred among 104/298 (35%) of the trial participants as compared to 295/549 (54%) of historical controls (19% difference, 95% CI: 12%, 26%, P < 0.001). No significant differences in the incidence of hospitalization were observed between cohorts. Protocol-based antimicrobial therapy for newly acquired Pa resulted in a lower rate of Pa recurrence but comparable hospitalization rates as compared to a historical control cohort less aggressively treated with antibiotics for new onset Pa. © 2013 Wiley Periodicals, Inc.

Standard Care versus Protocol Based Therapy for New Onset Pseudomonas aeruginosa in Cystic Fibrosis

PubMed Central

Mayer-Hamblett, Nicole; Rosenfeld, Margaret; Treggiari, Miriam M.; Konstan, Michael W.; Retsch-Bogart, George; Morgan, Wayne; Wagener, Jeff; Gibson, Ronald L.; Khan, Umer; Emerson, Julia; Thompson, Valeria; Elkin, Eric P.; Ramsey, Bonnie W.

2014-01-01

Rationale The Early Pseudomonal Infection Control (EPIC) randomized trial rigorously evaluated the efficacy of different antibiotic regimens for eradication of newly identified Pseudomonas (Pa) in children with cystic fibrosis (CF). Protocol based therapy in the trial was provided based on culture positivity independent of symptoms. It is unclear whether outcomes observed in the clinical trial were different than those that would have been observed with historical standard of care driven more heavily by respiratory symptoms than culture positivity alone. We hypothesized that the incidence of Pa recurrence and hospitalizations would be significantly reduced among trial participants as compared to historical controls whose standard of care preceded the widespread adoption of tobramycin inhalation solution (TIS) as initial eradication therapy at the time of new isolation of Pa. Methods Eligibility criteria from the trial were used to derive historical controls from the Epidemiologic Study of CF (ESCF) who received standard of care treatment from 1995 to 1998, before widespread availability of TIS. Pa recurrence and hospitalization outcomes were assessed over a 15-month time period. Results As compared to 100% of the 304 trial participants, only 296/608 (49%) historical controls received antibiotics within an average of 20 weeks after new onset Pa. Pa recurrence occurred among 104/298 (35%) of the trial participants as compared to 295/549 (54%) of historical controls (19% difference, 95% CI: 12%, 26%, p<0.001). No significant differences in the incidence of hospitalization were observed between cohorts. Conclusions Protocol-based antimicrobial therapy for newly acquired Pa resulted in a lower rate of Pa recurrence but comparable hospitalization rates as compared to a historical control cohort less aggressively treated with antibiotics for new onset Pa. PMID:23818295

Time-Lag Bias in Trials of Pediatric Antidepressants: A Systematic Review and Meta-Analysis

PubMed Central

Reyes, Magdalena M.; Panza, Kaitlyn E.; Martin, Andrés; Bloch, Michael H.

2013-01-01

Objective To determine if there is evidence of a time-lag bias in the publication of pediatric antidepressant trials. Method We conducted a meta-analysis of published and unpublished randomized, placebo-controlled trials of serotonin reuptake inhibitors (SRIs) in subjects less than 18 years old with major depressive disorder. Our main outcomes were (1) time to publication of positive versus negative trials, and (2) proportion of treatment responders in trials with standard (< 3 years after study completion) versus delayed publication. Results We identified 15 randomized, placebo-controlled trials of SRIs for pediatric depression. Trials with negative findings had a significantly longer time to publication (median years ± standard deviation = 4.2 ±1.9) than trials with positive findings (2.2 ±0.9; log-rank χ2 = 4.35, p = 0.037). The estimated efficacy in trials with standard publication time (number needed to treat = 7, 95% CI: 5 – 11) was significantly greater than those with delayed publication (17, 95% CI: 9 – ∞; χ2 = 4.98, p = 0.025). The inflation-adjusted impact factor of journals for published trials with positive (15.33 ±11.01) and negative results (7.54 ±7.90) did not statistically differ (t = 1.4, df = 10, p = 0.17). Conclusions Despite a small number of trials of SRIs for pediatric antidepressants we found a significant evidence of time-lag bias in the publication of findings. This time-lag bias altered the perceived efficacy of pediatric antidepressants in the medical literature. Time-lag bias is not unique to child psychiatry and reflects a larger problem in scientific publishing. PMID:21156271

Comparing the effects of positive and negative feedback in information-integration category learning.

PubMed

Freedberg, Michael; Glass, Brian; Filoteo, J Vincent; Hazeltine, Eliot; Maddox, W Todd

2017-01-01

Categorical learning is dependent on feedback. Here, we compare how positive and negative feedback affect information-integration (II) category learning. Ashby and O'Brien (2007) demonstrated that both positive and negative feedback are required to solve II category problems when feedback was not guaranteed on each trial, and reported no differences between positive-only and negative-only feedback in terms of their effectiveness. We followed up on these findings and conducted 3 experiments in which participants completed 2,400 II categorization trials across three days under 1 of 3 conditions: positive feedback only (PFB), negative feedback only (NFB), or both types of feedback (CP; control partial). An adaptive algorithm controlled the amount of feedback given to each group so that feedback was nearly equated. Using different feedback control procedures, Experiments 1 and 2 demonstrated that participants in the NFB and CP group were able to engage II learning strategies, whereas the PFB group was not. Additionally, the NFB group was able to achieve significantly higher accuracy than the PFB group by Day 3. Experiment 3 revealed that these differences remained even when we equated the information received on feedback trials. Thus, negative feedback appears significantly more effective for learning II category structures. This suggests that the human implicit learning system may be capable of learning in the absence of positive feedback.

Music and 25% glucose pain relief for the premature infant: a randomized clinical trial.

PubMed

Cardoso, Maria Vera Lúcia Moreira Leitão; Farias, Leiliane Martins; de Melo, Gleicia Martins

2014-10-01

To analyze the total Premature Infant Pain Profile scores of premature infants undergoing arterial puncture during music and 25% glucose interventions, and to assess their association with neonatal and therapeutic variables. A randomized clinical trial with 80 premature infants; 24 in the Experimental Group 1 (music), 33 in the Experimental Group 2 (music and 25% glucose), 23 in the Positive Control Group (25% glucose). All premature infants were videotaped and a lullaby was played for ten minutes before puncture in Experimental Groups 1 and 2; 25% glucose administered in Experimental Group 2 and the Positive Control Group two minutes before puncture. 60.0% of premature infants had moderate or maximum pain; pain scores and intervention groups were not statistically significant. Statistically significant variables: Experimental Group 1: head and chest circumference, Apgar scores, corrected gestational age; Experimental Group 2: chest circumference, Apgar scores, oxygen therapy; Positive Control group: birth weight, head circumference. Neonatal variables are associated with pain in premature infants. Brazilian Registry of Clinical Trials: UTN: U1111-1123-4821.

Systematic review of herbs and dietary supplements for glycemic control in diabetes.

PubMed

Yeh, Gloria Y; Eisenberg, David M; Kaptchuk, Ted J; Phillips, Russell S

2003-04-01

To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre, Aloe vera, vanadium, Momordica charantia, and nopal.

Efficacy of Coming Out Proud to reduce stigma's impact among people with mental illness: pilot randomised controlled trial.

PubMed

Rüsch, Nicolas; Abbruzzese, Elvira; Hagedorn, Eva; Hartenhauer, Daniel; Kaufmann, Ilias; Curschellas, Jan; Ventling, Stephanie; Zuaboni, Gianfranco; Bridler, René; Olschewski, Manfred; Kawohl, Wolfram; Rössler, Wulf; Kleim, Birgit; Corrigan, Patrick W

2014-01-01

Facing frequent stigma and discrimination, many people with mental illness have to choose between secrecy and disclosure in different settings. Coming Out Proud (COP), a 3-week peer-led group intervention, offers support in this domain in order to reduce stigma's negative impact. To examine COP's efficacy to reduce negative stigma-related outcomes and to promote adaptive coping styles (Current Controlled Trials number: ISRCTN43516734). In a pilot randomised controlled trial, 100 participants with mental illness were assigned to COP or a treatment-as-usual control condition. Outcomes included self-stigma, empowerment, stigma stress, secrecy and perceived benefits of disclosure. Intention-to-treat analyses found no effect of COP on self-stigma or empowerment, but positive effects on stigma stress, disclosure-related distress, secrecy and perceived benefits of disclosure. Some effects diminished during the 3-week follow-up period. Coming Out Proud has immediate positive effects on disclosure- and stigma stress-related variables and may thus alleviate stigma's negative impact.

Enhancing pediatric clinical trial feasibility through the use of Bayesian statistics.

PubMed

Huff, Robin A; Maca, Jeff D; Puri, Mala; Seltzer, Earl W

2017-11-01

BackgroundPediatric clinical trials commonly experience recruitment challenges including limited number of patients and investigators, inclusion/exclusion criteria that further reduce the patient pool, and a competitive research landscape created by pediatric regulatory commitments. To overcome these challenges, innovative approaches are needed.MethodsThis article explores the use of Bayesian statistics to improve pediatric trial feasibility, using pediatric Type-2 diabetes as an example. Data for six therapies approved for adults were used to perform simulations to determine the impact on pediatric trial size.ResultsWhen the number of adult patients contributing to the simulation was assumed to be the same as the number of patients to be enrolled in the pediatric trial, the pediatric trial size was reduced by 75-78% when compared with a frequentist statistical approach, but was associated with a 34-45% false-positive rate. In subsequent simulations, greater control was exerted over the false-positive rate by decreasing the contribution of the adult data. A 30-33% reduction in trial size was achieved when false-positives were held to less than 10%.ConclusionReducing the trial size through the use of Bayesian statistics would facilitate completion of pediatric trials, enabling drugs to be labeled appropriately for children.

Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

PubMed

Malmivaara, Antti

2015-06-01

The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

OARSI Clinical Trials Recommendations: Hand imaging in clinical trials in osteoarthritis.

PubMed

Hunter, D J; Arden, N; Cicuttini, F; Crema, M D; Dardzinski, B; Duryea, J; Guermazi, A; Haugen, I K; Kloppenburg, M; Maheu, E; Miller, C G; Martel-Pelletier, J; Ochoa-Albíztegui, R E; Pelletier, J-P; Peterfy, C; Roemer, F; Gold, G E

2015-05-01

Tremendous advances have occurred in our understanding of the pathogenesis of hand osteoarthritis (OA) and these are beginning to be applied to trials targeted at modification of the disease course. The purpose of this expert opinion, consensus driven exercise is to provide detail on how one might use and apply hand imaging assessments in disease modifying clinical trials. It includes information on acquisition methods/techniques (including guidance on positioning for radiography, sequence/protocol recommendations/hardware for MRI); commonly encountered problems (including positioning, hardware and coil failures, sequences artifacts); quality assurance/control procedures; measurement methods; measurement performance (reliability, responsiveness, validity); recommendations for trials; and research recommendations. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Dynamic adjustments of cognitive control: oscillatory correlates of the conflict adaptation effect.

PubMed

Pastötter, Bernhard; Dreisbach, Gesine; Bäuml, Karl-Heinz T

2013-12-01

It is a prominent idea that cognitive control mediates conflict adaptation, in that response conflict in a previous trial triggers control adjustments that reduce conflict in a current trial. In the present EEG study, we investigated the dynamics of cognitive control in a response-priming task by examining the effects of previous trial conflict on intertrial and current trial oscillatory brain activities, both on the electrode and the source level. Behavioral results showed conflict adaptation effects for RTs and response accuracy. Physiological results showed sustained intertrial effects in left parietal theta power, originating in the left inferior parietal cortex, and midcentral beta power, originating in the left and right (pre)motor cortex. Moreover, physiological analysis revealed a current trial conflict adaptation effect in midfrontal theta power, originating in the ACC. Correlational analyses showed that intertrial effects predicted conflict-induced midfrontal theta power in currently incongruent trials. In addition, conflict adaptation effects in midfrontal theta power and RTs were positively related. Together, these findings point to a dynamic cognitive control system that, as a function of previous trial type, up- and down-regulates attention and preparatory motor activities in anticipation of the next trial.

Autogenic training for stress and anxiety: a systematic review.

PubMed

Ernst, E; Kanji, N

2000-06-01

The aim of this systematic review was to evaluate all controlled trials of autogenic training (AT) as a means of reducing stress and anxiety levels in human subjects. A search for all published and unpublished controlled trials was carried out in the four major databases, specifically CISCOM, Medline, PsychLit and CINAHL. Eight such trials were located, all of which are included here. The majority of trials were methodologically flawed. A range of outcome measures were used, with Spielberger's State-Trait Anxiety Inventory being the most popular. Deviations from the accepted technique of AT were conspicuous and trials using the classical AT were in the minority. Seven trials reported positive effects of AT in reducing stress. One study showed no such benefit. Since one trial had used AT in combination with another technique, visual imagery, no conclusion can be drawn about the effect of AT in this case. No firm conclusions could be drawn from this systematic review. AT, properly applied, remains to be tested in controlled trials that are appropriately planned and executed.

Impact of a Social-Emotional and Character Development Program on School-Level Indicators of Academic Achievement, Absenteeism, and Disciplinary Outcomes: A Matched-Pair, Cluster-Randomized, Controlled Trial

ERIC Educational Resources Information Center

Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

2010-01-01

This article reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster-randomized, controlled design. The "Positive Action" Hawai'i trial included 20 racially/ethnically diverse…

Intervention for First Graders with Limited Number Knowledge: Large-Scale Replication of a Randomized Controlled Trial

ERIC Educational Resources Information Center

Gersten, Russell; Rolfhus, Eric; Clarke, Ben; Decker, Lauren E.; Wilkins, Chuck; Dimino, Joseph

2015-01-01

Replication studies are extremely rare in education. This randomized controlled trial (RCT) is a scale-up replication of Fuchs et al., which in a sample of 139 found a statistically significant positive impact for Number Rockets, a small-group intervention for at-risk first graders that focused on building understanding of number operations. The…

The Effect of a Microprocessor Prosthetic Foot on Function and Quality of Life in Transtibial Amputees Who Are Limited Community Ambulators

DTIC Science & Technology

2017-09-01

parallel, randomized, controlled clinical trial designed to determine if a microprocessor controlled prosthetic foot (MPF), with greater range of...clinical trial designed to determine if a microprocessor controlled prosthetic foot (MPF), with greater range of motion and active power, will...Department of the Army position, policy or decision unless so designated by other documentation. CONTRACTING ORGANIZATION: University of Tennessee

On being grateful and kind: results of two randomized controlled trials on study-related emotions and academic engagement.

PubMed

Ouweneel, Else; Le Blanc, Pascale M; Schaufeli, Wilmar B

2014-01-01

Despite the large amount of research attention to engagement as well as positive psychology in a general context, there have been few attempts to increase academic well-being by means of positive psychological interventions. This article tests the potential of positive psychological interventions to enhance study-related positive emotions and academic engagement, and to reduce study-related negative emotions among university students. We modified two existing positive interventions that are aimed at increasing general happiness for use in an academic context. These interventions focused on "thoughts of gratitude" and "acts of kindness," respectively. The present study consisted of two randomized controlled trials with experimental (thoughts of gratitude or acts of kindness) and control conditions in which participants were monitored on a daily basis during the one-week intervention, and additional pre-, post-, and follow-up assessments were carried out. Results revealed that the gratitude intervention had a significant positive effect on daily positive emotions only. The kindness intervention had a positive influence on both positive emotions and academic engagement, though not in the long run. The results showed no effects on negative emotions in either of the two interventions. Positive psychological interventions seem to foster positive emotions and academic engagement, but do not decrease negative emotions.

The effect of prone positioning in acute respiratory distress syndrome or acute lung injury: a meta-analysis. Areas of uncertainty and recommendations for research.

PubMed

Abroug, Fekri; Ouanes-Besbes, Lamia; Elatrous, Souheil; Brochard, Laurent

2008-06-01

To compare the effects of ventilation in prone and in supine position in patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS). Meta-analysis of randomised controlled trials. BioMedCentral, PubMed, CINAHL, and Embase (to November 2007), with additional information from authors. From selected randomised controlled trials comparing positioning in ALI/ARDS we extracted data concerning study design, disease severity, clinical outcomes, and adverse events. Five trials including 1,372 patients met the inclusion criteria for mortality analysis; one trial was added to assess the effects on acquisition of ventilator-associated pneumonia (VAP). The included trials were significantly underpowered and enrolled patients with varying severity. Prone positioning duration and mechanical ventilation strategy were not standardised across studies. Using a fixed-effects model, we did not find a significant effect of prone positioning (proning) on mortality (odds ratio 0.97, 95% confidence interval 0.77-1.22). The PaO(2)/FiO(2) ratio increased significantly more with proning (weighted means difference 25 mmHg, p < 0.00001). Proning was associated with a non-significant 23% reduction in the odds of VAP (p=0.09), and with no increase in major adverse airway complications: OR 1.01, 95% CI 0.71-1.43. Length of intensive care unit stay was marginally and not significantly increased by proning. Prone position is not associated with a significant reduction in mortality from ALI/ARDS despite a significant increase in PaO(2)/FiO(2), is safe, and tends to decrease VAP. Published studies exhibit substantial clinical heterogeneity, suggesting that an adequately sized study optimising the duration of proning and ventilation strategy is warranted to enable definitive conclusions to be drawn.

Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials.

PubMed

Wijeysundera, Duminda N; Austin, Peter C; Hux, Janet E; Beattie, W Scott; Laupacis, Andreas

2009-01-01

Randomized trials generally use "frequentist" statistics based on P-values and 95% confidence intervals. Frequentist methods have limitations that might be overcome, in part, by Bayesian inference. To illustrate these advantages, we re-analyzed randomized trials published in four general medical journals during 2004. We used Medline to identify randomized superiority trials with two parallel arms, individual-level randomization and dichotomous or time-to-event primary outcomes. Studies with P<0.05 in favor of the intervention were deemed "positive"; otherwise, they were "negative." We used several prior distributions and exact conjugate analyses to calculate Bayesian posterior probabilities for clinically relevant effects. Of 88 included studies, 39 were positive using a frequentist analysis. Although the Bayesian posterior probabilities of any benefit (relative risk or hazard ratio<1) were high in positive studies, these probabilities were lower and variable for larger benefits. The positive studies had only moderate probabilities for exceeding the effects that were assumed for calculating the sample size. By comparison, there were moderate probabilities of any benefit in negative studies. Bayesian and frequentist analyses complement each other when interpreting the results of randomized trials. Future reports of randomized trials should include both.

Video image position determination

DOEpatents

Christensen, Wynn; Anderson, Forrest L.; Kortegaard, Birchard L.

1991-01-01

An optical beam position controller in which a video camera captures an image of the beam in its video frames, and conveys those images to a processing board which calculates the centroid coordinates for the image. The image coordinates are used by motor controllers and stepper motors to position the beam in a predetermined alignment. In one embodiment, system noise, used in conjunction with Bernoulli trials, yields higher resolution centroid coordinates.

Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial.

PubMed

Hirshfield, Sabina; Downing, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

2016-06-17

Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Sex Positive!([+]) is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Participant recruitment began in June 2015 and ended in December 2015. This protocol describes the underlying theoretical framework and measures, study design, recruitment challenges, and antifraud measures for an online, video-based randomized controlled trial that has the potential to decrease HIV transmission risk behaviors among HIV-positive GBMSM who struggle with ART adherence. The Sex Positive!([+]) intervention allows for participation through multiple Internet-based mediums and has the potential to reach and engage a broader population of HIV-positive GBMSM who are virally unsuppressed. ClinicalTrials.gov NCT02023580; https://clinicaltrials.gov/ct2/show/NCT02023580 (Archived by WebCite at http://www.webcitation.org/6iHzA8wRG).

The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent

PubMed Central

Brim, Remy L; Miller, Franklin G

2013-01-01

There has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents. PMID:23239742

Study protocol. IDUS - Instrumental delivery & ultrasound: a multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery.

PubMed

Murphy, Deirdre J; Burke, Gerard; Montgomery, Alan A; Ramphul, Meenakshi

2012-09-13

Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 - 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Current Controlled Trials ISRCTN72230496.

A Randomized Controlled Trial Evaluation of "Time to Read", a Volunteer Tutoring Program for 8- to 9-Year-Olds

ERIC Educational Resources Information Center

Miller, Sarah; Connolly, Paul

2013-01-01

Tutoring is commonly employed to prevent early reading failure, and evidence suggests that it can have a positive effect. This article presents findings from a large-scale ("n" = 734) randomized controlled trial evaluation of the effect of "Time to Read"--a volunteer tutoring program aimed at children aged 8 to 9 years--on…

The Impact of Including Husbands in Antenatal Health Education Services on Maternal Health Practices in Urban Nepal: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Mullany, Britta C.; Becker, S.; Hindin, M. J.

2007-01-01

Observational studies suggest that including men in reproductive health interventions can enhance positive health outcomes. A randomized controlled trial was designed to test the impact of involving male partners in antenatal health education on maternal health care utilization and birth preparedness in urban Nepal. In total, 442 women seeking…

Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial

PubMed Central

Okesola, Nonhlanhla; Tanser, Frank; Thiebaut, Rodolphe; Rekacewicz, Claire; Newell, Marie-Louise

2016-01-01

Background The 2015 WHO recommendation of antiretroviral therapy (ART) for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART. Methods and Findings Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults) and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl) contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y) was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm), of whom 9,927 (77.0%) were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%), including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status). Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5%) visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218) initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196) had a CD4 count ≤ 350 cells/μl at first visit, of whom 92.8% initiated ART within 3 mo. Regarding attitudes about ART, 93% (8,802/9,460) of participants agreed with the statement that they would want to start ART as soon as possible if HIV-positive. Estimated baseline HIV prevalence was 30.5% (2,028/6,656) (95% CI 25.0%, 37.0%). HIV prevalence, uptake of home-based HIV testing, linkage to care within 6 mo, and initiation of ART within 3 mo in those with CD4 count ≤ 350 cells/μl did not differ significantly between the intervention and control clusters. Selection bias related to noncontact could not be entirely excluded. Conclusions Home-based HIV testing was well received in this rural population, although men were less easily contactable at home; immediate ART was acceptable, with good viral suppression and retention. However, only about half of HIV-positive people accessed care within 6 mo of being identified, with nearly two-thirds accessing care by 12 mo. The observed delay in linkage to care would limit the individual and public health ART benefits of universal testing and treatment in this population. Trial registration ClinicalTrials.gov NCT01509508 PMID:27504637

Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial.

PubMed

Kazemier, Brenda M; Koningstein, Fiona N; Schneeberger, Caroline; Ott, Alewijn; Bossuyt, Patrick M; de Miranda, Esteriek; Vogelvang, Tatjana E; Verhoeven, Corine J M; Langenveld, Josje; Woiski, Mallory; Oudijk, Martijn A; van der Ven, Jeanine E M; Vlegels, Manita T W; Kuiper, Petra N; Feiertag, Nicolette; Pajkrt, Eva; de Groot, Christianne J M; Mol, Ben W J; Geerlings, Suzanne E

2015-11-01

Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. In this multicentre prospective cohort study with an embedded randomised controlled trial, we screened women (aged ≥18 years) at eight hospitals and five ultrasound centres in the Netherlands with a singleton pregnancy between 16 and 22 weeks' gestation for asymptomatic bacteriuria. Screening was done with a single dipslide and two culture media. Dipslides were judged positive when the colony concentration was at least 1×10(5) colony-forming units (CFU) per mL of a single microorganism or when two different colony types were present but one had a concentration of at least 1×10(5) CFU per mL. Asymptomatic bacteriuria-positive women were eligible to participate in the randomised controlled trial comparing nitrofurantoin with placebo treatment. In this trial, participants were randomly assigned 1:1 to receive either nitrofurantoin 100 mg or identical placebo tablets, and were instructed to self-administer these tablets twice daily for 5 consecutive days. Randomisation was done by a web-based application with a computer-generated list with random block sizes of two, four, or six participants rendered by an independent data manager. 1 week after the end of treatment, they provided us with a follow-up dipslide. Women, treating physicians, and researchers all remained unaware of the bacteriuria status and treatment allocation. Women who refused to participate in the randomised controlled trial did not receive any antibiotics, but their outcomes were collected for analysis in the cohort study. We compared untreated and placebo-treated asymptomatic bacteriuria-positive women with asymptomatic bacteriuria-negative women and nitrofurantoin-treated asymptomatic bacteriuria-positive women. The primary endpoint was a composite of pyelonephritis with or without preterm birth at less than 34 weeks, analysed by intention to treat at 6 weeks post-partum. This trial is registered with the Dutch Trial Registry, number NTR3068. Between Oct 11, 2011, and June 10, 2013, we enrolled 5621 women into our screening cohort, of whom 5132 were eligible for screening. After exclusions for contaminated dipslides and patients lost to follow-up, in our final cohort of 4283 women, 248 were asymptomatic bacteriuria positive, of whom 40 were randomly assigned to nitrofurantoin and 45 to placebo for the randomised controlled trial, whereas the other 163 asymptomatic bacteriuria-positive women were followed without treatment. The proportion of women with pyelonephritis, preterm birth, or both did not differ between untreated or placebo-treated asymptomatic bacteriuria-positive women and asymptomatic bacteriuria-negative women (6 [2·9%] of 208 vs 77 [1·9%] of 4035; adjusted odds ratio [OR] 1·5, 95% CI 0·6-3·5) nor between asymptomatic bacteriuria-positive women treated with nitrofurantoin versus those who were untreated or received placebo (1 [2·5%] of 40 vs 6 [2·9%] of 208; risk difference -0·4, 95% CI -3·6 to 9·4). Untreated or placebo-treated asymptomatic bacteriuria-positive women developed pyelonephritis in five [2·4%] of 208 cases, compared with 24 [0·6%] of 4035 asymptomatic bacteriuria-negative women (adjusted OR 3·9, 95% CI 1·4-11·4). In women with an uncomplicated singleton pregnancy, asymptomatic bacteriuria is not associated with preterm birth. Asymptomatic bacteriuria showed a significant association with pyelonephritis, but the absolute risk of pyelonephritis in untreated asymptomatic bacteriuria is low. These findings question a routine screen-treat-policy for asymptomatic bacteriuria in pregnancy. ZonMw (the Netherlands Organisation for Health Research and Development). Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy for Psychopathology and Body Weight and Safety of Topiramate-Antipsychotic Cotreatment in Patients With Schizophrenia Spectrum Disorders: Results From a Meta-Analysis of Randomized Controlled Trials.

PubMed

Correll, Christoph U; Maayan, Lawrence; Kane, John; Hert, Marc De; Cohen, Dan

2016-06-01

To meta-analyze the efficacy and tolerability of topiramate-antipsychotic cotreatment in schizophrenia. PubMed/MEDLINE database were searched until September 5, 2015, using the keywords topiramate AND antipsych* OR neurolept* OR specific antipsychotic names. Randomized controlled trials (RCTs) of topiramate-antipsychotic cotreatment versus placebo and ongoing antipsychotic treatment in patients with schizophrenia spectrum disorders were included. Two evaluators extracted data. Standardized mean difference (SMD), weighted mean difference (WMD), and risk ratio (RR) ± 95% CIs were calculated. In 8 RCTs, lasting a mean ± SD of 13.6 ± 4.9 weeks, 439 patients were randomized to topiramate (100-400 mg/d) versus placebo (trials = 7) or ongoing antipsychotic treatment (trial = 1). Topiramate outperformed the comparator regarding total psychopathology (trials = 6, n = 269, SMD = -0.57 [95% CI, -1.01 to -0.14], P = .01), positive symptoms (trials = 4, n = 190, SMD = -0.56 [95% CI, -1.0 to -0.11], P = .01), negative symptoms (trials = 4, n = 190, SMD = -0.62 [95% CI, -1.13 to -0.10], P = .02) general psychopathology (trials = 3, n = 179, SMD = -0.69 [95% CI, -1.27 to -0.11], P = .02), body weight (trials = 7, n = 327, WMD = -3.14 kg [95% CI, -5.55 to -0.73], P = .01), and body mass index (BMI) (trials = 4, n = 198, WMD = -1.80 [95% CI, -2.77 to -0.84], P = .0003). Topiramate's efficacy for total psychopathology and weight reduction effects were not mediated/moderated by trial duration, topiramate dose, sex, age, inpatient status, baseline Positive and Negative Syndrome Scale, or baseline BMI. Conversely, clozapine-topiramate cotreatment moderated greater efficacy, but less weight loss, compared to topiramate-nonclozapine antipsychotic combinations. All-cause discontinuation was similar between topiramate and control groups (trials = 7, RR = 1.24 [95% CI, 0.76 to 2.02], P = .39). Topiramate trended only toward more paresthesia than placebo (trials = 4, RR = 2.03 [95 % CI, 0.99 to 4.18], P = .05). Topiramate-antipsychotic cotreatment significantly reduced total, positive, negative, and general psychopathology and weight/BMI in patients with schizophrenia spectrum disorder while being well tolerated. However, larger studies are needed to confirm and extend these findings. © Copyright 2016 Physicians Postgraduate Press, Inc.

Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda.

PubMed

Ruzagira, Eugene; Grosskurth, Heiner; Kamali, Anatoli; Baisley, Kathy

2017-10-01

The aim of this study was to determine whether counselling provided subsequent to HIV testing and referral for care increases linkage to care among HIV-positive persons identified through home-based HIV counselling and testing (HBHCT) in Masaka, Uganda. The study was an open-label cluster-randomized trial. 28 rural communities were randomly allocated (1:1) to intervention (HBHCT, referral and counselling at one and two months) or control (HBHCT and referral only). HIV-positive care-naïve adults (≥18 years) were enrolled. To conceal participants' HIV status, one HIV-negative person was recruited for every three HIV-positive participants. Primary outcomes were linkage to care (clinic-verified registration for care) status at six months, and time to linkage. Primary analyses were intention-to-treat using random effects logistic regression or Cox regression with shared frailty, as appropriate. Three hundred and two(intervention, n = 149; control, n = 153) HIV-positive participants were enrolled. Except for travel time to the nearest HIV clinic, baseline participant characteristics were generally balanced between trial arms. Retention was similar across trial arms (92% overall). One hundred and twenty-seven (42.1%) participants linked to care: 76 (51.0%) in the intervention arm versus 51 (33.3%) in the control arm [odds ratio = 2.18, 95% confidence interval (CI) = 1.26-3.78; p = 0.008)]. There was evidence of interaction between trial arm and follow-up time (p = 0.009). The probability of linkage to care, did not differ between arms in the first two months of follow-up, but was subsequently higher in the intervention arm versus the control arm [hazard ratio = 4.87, 95% CI = 1.79-13.27, p = 0.002]. Counselling substantially increases linkage to care among HIV-positive adults identified through HBHCT and may enhance efforts to increase antiretroviral therapy coverage in sub-Saharan Africa. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

Cluster Randomized Test-Negative Design (CR-TND) Trials: A Novel and Efficient Method to Assess the Efficacy of Community Level Dengue Interventions.

PubMed

Anders, Katherine L; Cutcher, Zoe; Kleinschmidt, Immo; Donnelly, Christl A; Ferguson, Neil M; Indriani, Citra; O'Neill, Scott L; Jewell, Nicholas P; Simmons, Cameron P

2018-05-07

Cluster randomized trials are the gold standard for assessing efficacy of community-level interventions, such as vector control strategies against dengue. We describe a novel cluster randomized trial methodology with a test-negative design, which offers advantages over traditional approaches. It utilizes outcome-based sampling of patients presenting with a syndrome consistent with the disease of interest, who are subsequently classified as test-positive cases or test-negative controls on the basis of diagnostic testing. We use simulations of a cluster trial to demonstrate validity of efficacy estimates under the test-negative approach. This demonstrates that, provided study arms are balanced for both test-negative and test-positive illness at baseline and that other test-negative design assumptions are met, the efficacy estimates closely match true efficacy. We also briefly discuss analytical considerations for an odds ratio-based effect estimate arising from clustered data, and outline potential approaches to analysis. We conclude that application of the test-negative design to certain cluster randomized trials could increase their efficiency and ease of implementation.

Prone positioning in hypoxemic respiratory failure: meta-analysis of randomized controlled trials.

PubMed

Kopterides, Petros; Siempos, Ilias I; Armaganidis, Apostolos

2009-03-01

Prone positioning is used to improve oxygenation in patients with hypoxemic respiratory failure (HRF). However, its role in clinical practice is not yet clearly defined. The aim of this meta-analysis was to assess the effect of prone positioning on relevant clinical outcomes, such as intensive care unit (ICU) and hospital mortality, days of mechanical ventilation, length of stay, incidence of ventilator-associated pneumonia (VAP) and pneumothorax, and associated complications. We used literature search of MEDLINE, Current Contents, and Cochrane Central Register of Controlled Trials. We focused only on randomized controlled trials reporting clinical outcomes in adult patients with HRF. Four trials met our inclusion criteria, including 662 patients randomized to prone ventilation and 609 patients to supine ventilation. The pooled odds ratio (OR) for the ICU mortality in the intention-to-treat analysis was 0.97 (95% confidence interval [CI], 0.77-1.22), for the comparison between prone and supine ventilated patients. Interestingly, the pooled OR for the ICU mortality in the selected group of the more severely ill patients favored prone positioning (OR, 0.34; 95% CI, 0.18-0.66). The duration of mechanical ventilation and the incidence of pneumothorax were not different between the 2 groups. The incidence of VAP was lower but not statistically significant in patients treated with prone positioning (OR, 0.81; 95% CI, 0.61-1.10). However, prone positioning was associated with a higher risk of pressure sores (OR, 1.49; 95% CI, 1.17-1.89) and a trend for more complications related to the endotracheal tube (OR, 1.30; 95% CI, 0.94-1.80). Despite the inherent limitations of the meta-analytic approach, it seems that prone positioning has no discernible effect on mortality in patients with HRF. It may decrease the incidence of VAP at the expense of more pressure sores and complications related to the endotracheal tube. However, a subgroup of the most severely ill patients may benefit most from this intervention.

14th International Congress on Antiphospholipid Antibodies: task force report on antiphospholipid syndrome treatment trends.

PubMed

Erkan, Doruk; Aguiar, Cassyanne L; Andrade, Danieli; Cohen, Hannah; Cuadrado, Maria J; Danowski, Adriana; Levy, Roger A; Ortel, Thomas L; Rahman, Anisur; Salmon, Jane E; Tektonidou, Maria G; Willis, Rohan; Lockshin, Michael D

2014-06-01

Antiphospholipid Syndrome (APS) is characterized by vascular thrombosis and/or pregnancy morbidity occurring in patients with persistent antiphospholipid antibodies (aPL). The primary objective of the APS Treatment Trends Task Force, created as part of the 14th International Congress on aPL, was to systematically review the potential future treatment strategies for aPL-positive patients. The task force chose as future clinical research directions: a) determining the necessity for controlled clinical trials in venous thromboembolism with the new oral direct thrombin or anti-factor Xa inhibitors pending the results of the ongoing rivaroxaban in APS (RAPS) trial, and designing controlled clinical trials in other forms of thrombotic APS; b) systematically analyzing the literature as well as aPL/APS registries, and creating specific registries for non-warfarin/heparin anticoagulants; c) increasing recruitment for an ongoing primary thrombosis prevention trial, and designing secondary thrombosis and pregnancy morbidity prevention trials with hydroxychloroquine; d) determining surrogate markers to select patients for statin trials; e) designing controlled studies with rituximab and other anti-B-cell agents; f) designing mechanistic and clinical studies with eculizumab and other complement inhibitors; and g) chemically modifying peptide therapy to improve the half-life and minimize immunogenicity. The report also includes recommendations for clinicians who consider using these agents in difficult-to-manage aPL-positive patients. Copyright © 2014 Elsevier B.V. All rights reserved.

Vision-based real-time position control of a semi-automated system for robot-assisted joint fracture surgery.

PubMed

Dagnino, Giulio; Georgilas, Ioannis; Tarassoli, Payam; Atkins, Roger; Dogramadzi, Sanja

2016-03-01

Joint fracture surgery quality can be improved by robotic system with high-accuracy and high-repeatability fracture fragment manipulation. A new real-time vision-based system for fragment manipulation during robot-assisted fracture surgery was developed and tested. The control strategy was accomplished by merging fast open-loop control with vision-based control. This two-phase process is designed to eliminate the open-loop positioning errors by closing the control loop using visual feedback provided by an optical tracking system. Evaluation of the control system accuracy was performed using robot positioning trials, and fracture reduction accuracy was tested in trials on ex vivo porcine model. The system resulted in high fracture reduction reliability with a reduction accuracy of 0.09 mm (translations) and of [Formula: see text] (rotations), maximum observed errors in the order of 0.12 mm (translations) and of [Formula: see text] (rotations), and a reduction repeatability of 0.02 mm and [Formula: see text]. The proposed vision-based system was shown to be effective and suitable for real joint fracture surgical procedures, contributing a potential improvement of their quality.

A randomized controlled trial of positioning treatments in infants with positional head shape deformities.

PubMed

Hutchison, B Lynne; Stewart, Alistair W; De Chalain, Tristan B; Mitchell, Edwin A

2010-10-01

Randomized controlled trials of treatment for deformational plagiocephaly and brachycephaly have been lacking in the literature. Infants (n = 126) presenting to a plagiocephaly clinic were randomized to either positioning strategies or to positioning plus the use of a Safe T Sleep™ positioning wrap. Head shape was measured using a digital photographic technique, and neck function was assessed. They were followed up at home 3, 6 and 12 months later. There was no difference in head shape outcomes for the two treatment groups after 12 months of follow-up, with 42% of infants having head shapes in the normal range by that time. Eighty per cent of children showed good improvement. Those that had poor improvement were more likely to have both plagiocephaly and brachycephaly and to have presented later to clinic. Most infants improved over the 12-month study period, although the use of a sleep positioning wrap did not increase the rate of improvement. © 2010 The Author(s)/Journal Compilation © 2010 Foundation Acta Paediatrica.

Pediatric-based intervention to motivate mothers to seek follow-up for depression screens: The Motivating Our Mothers (MOM) trial.

PubMed

Fernandez y Garcia, Erik; Joseph, Jill; Wilson, Machelle D; Hinton, Ladson; Simon, Gregory; Ludman, Evette; Scott, Fiona; Kravitz, Richard L

2015-01-01

To determine the initial effectiveness of a novel, pediatric office-based intervention in motivating mothers to seek further assessment of positive depression screens. In this pilot randomized controlled trial, English-speaking mothers (n = 104) with positive 2-question depression screens and presenting with children 0 to 12 years old for well-child care to a general pediatric training clinic received interventions from a trained research assistant. The Motivating Our Mothers (MOM) intervention included office-based written and verbal targeted depression education and motivational messages encouraging further depression assessment and a semistructured telephone booster delivered 2 days later. The control intervention included nontargeted written and verbal messages and 2 days later, an attention control telephone survey. Both groups received a list of depression care resources. The primary outcome was the proportion of mothers in each group who reported trying to contact any of 6 types of resources to discuss the positive screen at 2 weeks after intervention (ClinicalTrials.gov NCT01453790). Despite 6 contact attempts, 10 MOM and 9 control mothers were lost to follow-up. More mothers in the MOM intervention tried to contact a resource compared to control (73.8% vs 53.5%, difference 20.3%, 95% confidence interval for difference -0.1 to 38.5, P = .052). Mothers receiving the MOM intervention made more attempts to contact a resource for follow-up of positive depression screens. If found effective in larger studies, MOM may prove a promising approach for motivating depression screen-positive mothers identified in general pediatric settings within and beyond the postpartum period to seek further depression assessment and support. Copyright © 2015 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Intensive glycemic control and cardiovascular disease: an update.

PubMed

Brown, Aparna; Reynolds, L Raymond; Bruemmer, Dennis

2010-07-01

Cardiovascular complications constitute the major cause of morbidity and mortality in patients with diabetes. The Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) provided consistent evidence that intensive glycemic control prevents the development and progression of microvascular complications in patients with type 1 or type 2 diabetes. However, whether intensive glucose lowering also prevents macrovascular disease and major cardiovascular events remains unclear. Extended follow-up of participants in these studies demonstrated that intensive glycemic control reduced the long-term incidence of myocardial infarction and death from cardiovascular disease. By contrast, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial, and Veterans Affairs Diabetes Trial (VADT) results suggested that intensive glycemic control to near normoglycemia had either no, or potentially even a detrimental, effect on cardiovascular outcomes. This article discusses the effects of intensive glycemic control on cardiovascular disease, and examines key differences in the design of these trials that might have contributed to their disparate findings. Recommendations from the current joint ADA, AHA, and ACCF position statement on intensive glycemic control and prevention of cardiovascular disease are highlighted.

The effects of mental practice in neurological rehabilitation; a systematic review and meta-analysis

PubMed Central

Braun, Susy; Kleynen, Melanie; van Heel, Tessa; Kruithof, Nena; Wade, Derick; Beurskens, Anna

2013-01-01

Objective: To investigate the beneficial and adverse effects of a mental practice intervention on activities, cognition, and emotion in patients after stroke, patients with Parkinson's disease or multiple sclerosis. Methods: Electronic databases PubMed/Medline, PEDro, Science Direct, Cochrane Library, PsycINFO, Rehadat, Embase, and Picarta were searched until June 2012. Fourteen randomized controlled trials in stroke and two randomized controlled trials in Parkinson's disease were included, representing 491 patients (421 with stroke). No randomized controlled trials in multiple sclerosis were identified. The methodologic quality of the included trials was assessed with the Amsterdam-Maastricht-Consensus-List (AMCL). Information on study characteristics and outcomes was summarized and evidence for effects described. Data from individual studies in stroke with same outcome measures were pooled. Results: The included 16 randomized controlled trials were heterogeneous and methodologic quality varied. Ten trials reported significant effects in favor of mental practice in patients with stroke (n = 9) and Parkinson's disease (n = 1). In six studies mental practice had similar effects as therapy as usual (n = 5 in stroke and n = 1 in Parkinson's disease). Of six performed meta-analyses with identical measures in stroke studies only two showed significant effects of mental practice: short-term improvement of arm-hand-ability (ARAT: SMD 0.62; 95% CI: 0.05 to 1.19) and improvement of performance of activities (NRS: SMD 0.9; 95% CI: 0.04 to 1.77). Five studies found effects on cognition (e.g., effects on attention, plan actions in unfamiliar surroundings) and four reported observed side-effects, both positive (e.g., might increase motivation and arousal and reduce depression) and negative (e.g., diminished concentration, irritation). Conclusions: Mental practice might have positive effects on performance of activities in patients with neurological diseases, but this review reports less positive results than earlier published ones. Strengths and limitations of past studies are pointed out. Methodologic recommendations for future studies are given. PMID:23935572

Increased susceptibility to proactive interference in adults with dyslexia?

PubMed

Bogaerts, Louisa; Szmalec, Arnaud; Hachmann, Wibke M; Page, Mike P A; Woumans, Evy; Duyck, Wouter

2015-01-01

Recent findings show that people with dyslexia have an impairment in serial-order memory. Based on these findings, the present study aimed to test the hypothesis that people with dyslexia have difficulties dealing with proactive interference (PI) in recognition memory. A group of 25 adults with dyslexia and a group of matched controls were subjected to a 2-back recognition task, which required participants to indicate whether an item (mis)matched the item that had been presented 2 trials before. PI was elicited using lure trials in which the item matched the item in the 3-back position instead of the targeted 2-back position. Our results demonstrate that the introduction of lure trials affected 2-back recognition performance more severely in the dyslexic group than in the control group, suggesting greater difficulty in resisting PI in dyslexia.

Word repetition in amnesia. Electrophysiological measures of impaired and spared memory.

PubMed

Olichney, J M; Van Petten, C; Paller, K A; Salmon, D P; Iragui, V J; Kutas, M

2000-09-01

Amnesic patients often show improved performance when stimuli are repeated, even in the absence of conscious memory for those stimuli. Although these performance changes are typically attributed to perceptual or motor systems, in some cases they may be related to basic language processing. We examined two neurophysiological measures that vary with word repetition in 12 amnesic patients and 12 control subjects: (i) a late positive component of the event-related potential (ERP) linked to conscious memory and (ii) the N400 component that varies with language comprehension. In each trial, the subject heard a category name, then viewed a word, and then decided whether the word was semantically congruous or incongruous (e.g. 'yes' for 'baby animal: cub'; 'no' for 'water sport: kitchen'). Recall and recognition testing at the end of the experiment showed that control subjects had better memory for congruous than for incongruous words, as did the amnesic patients, who performed less well overall. In contrast, amnesic patients were unimpaired on the category decisions required in each trial and, like the control subjects, showed a large N400 for incongruous relative to congruous words. Similarly, when incongruous trials were repeated after 0-13 intervening trials, N400s were reduced in both groups. When congruous trials were repeated, a late positive repetition effect was observed, but only in the control group. Furthermore, the amplitude of the late positive repetition effect was highly correlated with later word recall in both patients and controls. In the patients, the correlation was also observed with memory scores from standardized neuropsychological tests. These data are consistent with a proposed link between the late positive repetition effect and conscious memory. On the other hand, the N400 repetition effect was not correlated with episodic memory abilities, but instead indexed an aspect of memory that was intact in the amnesic patients. The preserved N400 repetition effect is an example of preserved memory in amnesia that does not easily fit into the categories of low-level perceptual processing or of motor learning. Instead, the sensitivity of the N400 to both semantic context and repetition may reflect a short-term memory process that serves language comprehension in realtime.

Does the Effort of Processing Potential Incentives Influence the Adaption of Context Updating in Older Adults?

PubMed Central

Schmitt, Hannah; Kray, Jutta; Ferdinand, Nicola K.

2017-01-01

A number of aging studies suggest that older adults process positive and negative information differently. For instance, the socioemotional selectivity theory postulates that older adults preferably process positive information in service of emotional well-being (Reed and Carstensen, 2012). Moreover, recent research has started to investigate whether incentives like gains or losses can influence cognitive control in an ongoing task. In an earlier study (Schmitt et al., 2015), we examined whether incentive cues, indicating potential monetary gains, losses, or neutral outcomes for good performance in the following trial, would influence older adults’ ability to exert cognitive control. Cognitive control was measured in an AX-Continuous-Performance-Task (AX-CPT) in which participants had to select their responses to probe stimuli depending on a preceding context cue. In this study, we did not find support for a positivity effect in older adults, but both gains and losses led to enhanced context processing. As the trial-wise presentation mode may be too demanding on cognitive resources for such a bias to occur, the main goal of the present study was to examine whether motivational mindsets, induced by block-wise presentation of incentives, would result in a positivity effect. For this reason, we examined 17 older participants (65–76 years) in the AX-CPT using a block-wise presentation of incentive cues and compared them to 18 older adults (69–78 years) with the trial-wise presentation mode from our earlier study (Schmitt et al., 2015). Event-related potentials were recorded to the onset of the motivational cue and during the AX-CPT. Our results show that (a) older adults initially process cues signaling potential losses more strongly, but later during the AX-CPT invest more cognitive resources in preparatory processes like context updating in conditions with potential gains, and (b) block-wise and trial-wise presentation of incentive cues differentially influenced cognitive control. When incentives were presented block-wise, the above described valence effects were consistently found. In contrast, when incentives were presented trial-wise, the effects were mixed and salience as well as valence effects can be obtained. Hence, how positive and negative incentive cues influence cognitive control in older adults is dependent on demands of cue processing. PMID:29170649

Does the Effort of Processing Potential Incentives Influence the Adaption of Context Updating in Older Adults?

PubMed

Schmitt, Hannah; Kray, Jutta; Ferdinand, Nicola K

2017-01-01

A number of aging studies suggest that older adults process positive and negative information differently. For instance, the socioemotional selectivity theory postulates that older adults preferably process positive information in service of emotional well-being (Reed and Carstensen, 2012). Moreover, recent research has started to investigate whether incentives like gains or losses can influence cognitive control in an ongoing task. In an earlier study (Schmitt et al., 2015), we examined whether incentive cues, indicating potential monetary gains, losses, or neutral outcomes for good performance in the following trial, would influence older adults' ability to exert cognitive control. Cognitive control was measured in an AX-Continuous-Performance-Task (AX-CPT) in which participants had to select their responses to probe stimuli depending on a preceding context cue. In this study, we did not find support for a positivity effect in older adults, but both gains and losses led to enhanced context processing. As the trial-wise presentation mode may be too demanding on cognitive resources for such a bias to occur, the main goal of the present study was to examine whether motivational mindsets, induced by block-wise presentation of incentives, would result in a positivity effect. For this reason, we examined 17 older participants (65-76 years) in the AX-CPT using a block-wise presentation of incentive cues and compared them to 18 older adults (69-78 years) with the trial-wise presentation mode from our earlier study (Schmitt et al., 2015). Event-related potentials were recorded to the onset of the motivational cue and during the AX-CPT. Our results show that (a) older adults initially process cues signaling potential losses more strongly, but later during the AX-CPT invest more cognitive resources in preparatory processes like context updating in conditions with potential gains, and (b) block-wise and trial-wise presentation of incentive cues differentially influenced cognitive control. When incentives were presented block-wise, the above described valence effects were consistently found. In contrast, when incentives were presented trial-wise, the effects were mixed and salience as well as valence effects can be obtained. Hence, how positive and negative incentive cues influence cognitive control in older adults is dependent on demands of cue processing.

Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

PubMed

Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

2011-06-01

To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

Effect of visuomotor-map uncertainty on visuomotor adaptation.

PubMed

Saijo, Naoki; Gomi, Hiroaki

2012-03-01

Vision and proprioception contribute to generating hand movement. If a conflict between the visual and proprioceptive feedback of hand position is given, reaching movement is disturbed initially but recovers after training. Although previous studies have predominantly investigated the adaptive change in the motor output, it is unclear whether the contributions of visual and proprioceptive feedback controls to the reaching movement are modified by visuomotor adaptation. To investigate this, we focused on the change in proprioceptive feedback control associated with visuomotor adaptation. After the adaptation to gradually introduce visuomotor rotation, the hand reached the shifted position of the visual target to move the cursor to the visual target correctly. When the cursor feedback was occasionally eliminated (probe trial), the end point of the hand movement was biased in the visual-target direction, while the movement was initiated in the adapted direction, suggesting the incomplete adaptation of proprioceptive feedback control. Moreover, after the learning of uncertain visuomotor rotation, in which the rotation angle was randomly fluctuated on a trial-by-trial basis, the end-point bias in the probe trial increased, but the initial movement direction was not affected, suggesting a reduction in the adaptation level of proprioceptive feedback control. These results suggest that the change in the relative contribution of visual and proprioceptive feedback controls to the reaching movement in response to the visuomotor-map uncertainty is involved in visuomotor adaptation, whereas feedforward control might adapt in a manner different from that of the feedback control.

Role of Muscarinic Acetylcholine Receptors in Serial Feature-Positive Discrimination Task during Eyeblink Conditioning in Mice

PubMed Central

Rahman, Md. Ashrafur; Tanaka, Norifumi; Usui, Koji; Kawahara, Shigenori

2016-01-01

We investigated the role of muscarinic acetylcholine receptors (mAChRs) in eyeblink serial feature-positive discrimination learning in mice using the mAChR antagonist. A 2-s light cue was delivered 5 or 6 s before the presentation of a 350-ms tone paired with a 100-ms periorbital electrical shock (cued trial) but not before the tone-alone presentation (non-cued trial). Mice received 30 cued and 30 non-cued trials each day in a random order. We found that saline-injected control mice were successfully discriminating between cued and non-cued trials within a few days of conditioning. The mice responded more frequently to the tone in cued trials than in non-cued trials. Analysis of conditioned response (CR) dynamics revealed that the CR onset latency was shorter in cued trials than in non-cued trials, despite the CR peak amplitude not differing significantly between the two conditions. In contrast, scopolamine-injected mice developed an equal number of CRs with similar temporal patterns irrespective of the presence of the cue during the 7 days of conditioning, indicating in a failure to acquire conditional discrimination. In addition, the scopolamine administration to the control mice after they had successfully acquired discrimination did not impair the conditional discrimination and expression of pre-acquired CR. These results suggest that mAChRs may play a pivotal role in memory formation in the conditional brain state associated with the feature cue; however they are unlikely to be involved in the development of discrimination after conditional memory had formed in the serial feature-positive discrimination task during eyeblink conditioning. PMID:26808980

Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

PubMed Central

Blakeman, Tom; Blickem, Christian; Kennedy, Anne; Reeves, David; Bower, Peter; Gaffney, Hannah; Gardner, Caroline; Lee, Victoria; Jariwala, Praksha; Dawson, Shoba; Mossabir, Rahena; Brooks, Helen; Richardson, Gerry; Spackman, Eldon; Vassilev, Ivaylo; Chew-Graham, Carolyn; Rogers, Anne

2014-01-01

Background Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. Trial Registration Controlled-Trials.com ISRCTN45433299 PMID:25330169

Efficacy of Coming Out Proud to reduce stigma’s impact among people with mental illness: pilot randomised controlled trial

PubMed Central

Rüsch, Nicolas; Abbruzzese, Elvira; Hagedorn, Eva; Hartenhauer, Daniel; Kaufmann, Ilias; Curschellas, Jan; Ventling, Stephanie; Zuaboni, Gianfranco; Bridler, René; Olschewski, Manfred; Kawohl, Wolfram; Rössler, Wulf; Kleim, Birgit; Corrigan, Patrick W.

2014-01-01

Background Facing frequent stigma and discrimination, many people with mental illness have to choose between secrecy and disclosure in different settings. Coming Out Proud (COP), a 3-week peer-led group intervention, offers support in this domain in order to reduce stigma’s negative impact. Aims To examine COP’s efficacy to reduce negative stigma-related outcomes and to promote adaptive coping styles (Current Controlled Trials number: ISRCTN43516734). Method In a pilot randomised controlled trial, 100 participants with mental illness were assigned to COP or a treatment-as-usual control condition. Outcomes included self-stigma, empowerment, stigma stress, secrecy and perceived benefits of disclosure. Results Intention-to-treat analyses found no effect of COP on self-stigma or empowerment, but positive effects on stigma stress, disclosure-related distress, secrecy and perceived benefits of disclosure. Some effects diminished during the 3-week follow-up period. Conclusions Coming Out Proud has immediate positive effects on disclosure- and stigma stress-related variables and may thus alleviate stigma’s negative impact. PMID:24434073

Sleep Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

DTIC Science & Technology

2016-10-01

Cognition, Quality of Life, and Cardiovascular Disease PRINCIPAL INVESTIGATOR: Shirin Shafazand, MD, MS CONTRACTING ORGANIZATION: University of Miami...with positive airway pressure (PAP) will improve cognitive impairment, sleep quality, quality of life, and cardiovascular disease (CVD) surrogate...Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease Shirin Shafazand, MD, MS Nothing listed 12

Omega 3/6 Fatty Acids for Reading in Children: A Randomized, Double-Blind, Placebo-Controlled Trial in 9-Year-Old Mainstream Schoolchildren in Sweden

ERIC Educational Resources Information Center

Johnson, Mats; Fransson, Gunnar; Östlund, Sven; Areskoug, Björn; Gillberg, Christopher

2017-01-01

Background: Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods: We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active…

Learning-based position control of a closed-kinematic chain robot end-effector

NASA Technical Reports Server (NTRS)

Nguyen, Charles C.; Zhou, Zhen-Lei

1990-01-01

A trajectory control scheme whose design is based on learning theory, for a six-degree-of-freedom (DOF) robot end-effector built to study robotic assembly of NASA hardwares in space is presented. The control scheme consists of two control systems: the feedback control system and the learning control system. The feedback control system is designed using the concept of linearization about a selected operating point, and the method of pole placement so that the closed-loop linearized system is stabilized. The learning control scheme consisting of PD-type learning controllers, provides additional inputs to improve the end-effector performance after each trial. Experimental studies performed on a 2 DOF end-effector built at CUA, for three tracking cases show that actual trajectories approach desired trajectories as the number of trials increases. The tracking errors are substantially reduced after only five trials.

Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial.

PubMed

Liang, Yan; Ma, Jingchen; Li, Changgui; Chen, Yuguo; Liu, Longding; Liao, Yun; Zhang, Ying; Jiang, Li; Wang, Xuan-Yi; Che, Yanchun; Deng, Wei; Li, Hong; Cui, Xiaoyu; Ma, Na; Ding, Dong; Xie, Zhongping; Cui, Pingfang; Ji, Qiuyan; Wang, JingJing; Zhao, Yuliang; Wang, Junzhi; Li, Qihan

2014-01-01

Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas. A randomized, double-blind, controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted. A total of 300 subjects were enrolled and divided into 4 age groups: 16-60 years, 5-16 years, 2-5 years and 8-24 months. The groups were immunized with one injection per subject. Three different doses of the F-genotype attenuated mumps vaccine, A (3.5 ± 0.25 logCCID50), B (4.25 ± 0.25 logCCID50) and C (5.0 ± 0.25 logCCID50), as well as a placebo control and a positive control of a licensed A-genotype vaccine (S79 strain) were used. The safety and immunogenicity of this vaccine were compared with those of the controls. The safety evaluation suggested that mild adverse reactions were observed in all groups. No serious adverse event (SAE) was reported throughout the trial. The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2- to 5-year-old and 8- to 24-month-old groups compared with the seroconversion rate in the positive control. The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group. The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control.

A Mock Randomized Controlled Trial With Audience Response Technology for Teaching and Learning Epidemiology.

PubMed

Baker, Philip R A; Francis, Daniel P; Cathcart, Abby

2017-04-01

The study's objective was to apply and assess an active learning approach to epidemiology and critical appraisal. Active learning comprised a mock, randomized controlled trial (RCT) conducted with learners in 3 countries. The mock trial consisted of blindly eating red Smarties candy (intervention) compared to yellow Smarties (control) to determine whether red Smarties increase happiness. Audience response devices were employed with the 3-fold purposes to produce outcome data for analysis of the effects of red Smarties, identify baseline and subsequent changes in participant's knowledge and confidence in understanding of RCTs, and assess the teaching approach. Of those attending, 82% (117 of 143 learners) participated in the trial component. Participating in the mock trial was a positive experience, and the use of the technology aided learning. The trial produced data that learners analyzed in "real time" during the class. The mock RCT is a fun and engaging approach to teaching RCTs and helping students to develop skills in critical appraisal.

Does debulking of enlarged positive lymph nodes improve survival in different gynaecological cancers?

PubMed

Somashekhar, S P

2015-08-01

Lymph-node-positive gynaecological cancers remain a pharmacotherapeutic challenge, and patients with lymph-node-positive gynaecological cancers have poor survival. The purpose of this review is to determine whether a survival advantage arises from surgical debulking of enlarged positive lymph nodes in different types of gynaecological cancers. Information from studies published on the survival benefits from debulking lymph nodes in gynaecological cancers was investigated. Pertaining to therapeutic lymphadenectomy, survival benefit can be analysed in two ways, direct survival benefit following therapeutic lymphadenectomy of bulky positive metastatic lymph nodes and indirect survival benefit, which results after a sequela of systematic lymphadenectomy, proper, accurate staging of disease and stage migration and tailor-made adjuvant treatment. The direct hypothesis of therapeutic lymphadenectomy and survival benefit has been prospected in cervical cancers and vulval cancers and in post-chemotherapy residual paraarotic nodal mass in germ cell ovarian cancer. The indirect survival benefit of therapeutic paraarotic lymphadenectomy in high-risk endometrial cancers and advanced epithelial ovarian cancers needs to be tested in randomized controlled trials. More randomized controlled trials are required to investigate this research question. Further, indirect benefit due to tailor-made adjuvant treatment, secondary to accurate staging achieved as a sequela of systematic lymphadenectomy, needs to be analysed in future trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

PubMed Central

Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

2015-01-01

Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial Registration The Netherlands Trial Register NTR4297; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4297 (Archived by WebCite at http://webcitation.org/6Uwb5SUUM). PMID:26293678

OARSI Clinical Trials Recommendations for Hip Imaging in Osteoarthritis

PubMed Central

Gold, Garry E.; Cicuttini, Flavia; Crema, Michel D.; Eckstein, Felix; Guermazi, Ali; Kijowski, Richard; Link, Thomas M.; Maheu, Emmanuel; Martel-Pelletier, Johanne; Miller, Colin G.; Pelletier, Jean-Pierre; Peterfy, Charles G.; Potter, Hollis G.; Roemer, Frank W.; Hunter, David. J

2015-01-01

Imaging of hip in osteoarthritis (OA) has seen considerable progress in the past decade, with the introduction of new techniques that may be more sensitive to structural disease changes. The purpose of this expert opinion, consensus driven recommendation is to provide detail on how to apply hip imaging in disease modifying clinical trials. It includes information on acquisition methods/ techniques (including guidance on positioning for radiography, sequence/protocol recommendations/ hardware for MRI); commonly encountered problems (including positioning, hardware and coil failures, artifacts associated with various MRI sequences); quality assurance/ control procedures; measurement methods; measurement performance (reliability, responsiveness, and validity); recommendations for trials; and research recommendations. PMID:25952344

Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial.

PubMed

Iwuji, Collins C; Orne-Gliemann, Joanna; Larmarange, Joseph; Okesola, Nonhlanhla; Tanser, Frank; Thiebaut, Rodolphe; Rekacewicz, Claire; Newell, Marie-Louise; Dabis, Francois

2016-08-01

The 2015 WHO recommendation of antiretroviral therapy (ART) for all immediately following HIV diagnosis is partially based on the anticipated impact on HIV incidence in the surrounding population. We investigated this approach in a cluster-randomised trial in a high HIV prevalence setting in rural KwaZulu-Natal. We present findings from the first phase of the trial and report on uptake of home-based HIV testing, linkage to care, uptake of ART, and community attitudes about ART. Between 9 March 2012 and 22 May 2014, five clusters in the intervention arm (immediate ART offered to all HIV-positive adults) and five clusters in the control arm (ART offered according to national guidelines, i.e., CD4 count ≤ 350 cells/μl) contributed to the first phase of the trial. Households were visited every 6 mo. Following informed consent and administration of a study questionnaire, each resident adult (≥16 y) was asked for a finger-prick blood sample, which was used to estimate HIV prevalence, and offered a rapid HIV test using a serial HIV testing algorithm. All HIV-positive adults were referred to the trial clinic in their cluster. Those not linked to care 3 mo after identification were contacted by a linkage-to-care team. Study procedures were not blinded. In all, 12,894 adults were registered as eligible for participation (5,790 in intervention arm; 7,104 in control arm), of whom 9,927 (77.0%) were contacted at least once during household visits. HIV status was ever ascertained for a total of 8,233/9,927 (82.9%), including 2,569 ascertained as HIV-positive (942 tested HIV-positive and 1,627 reported a known HIV-positive status). Of the 1,177 HIV-positive individuals not previously in care and followed for at least 6 mo in the trial, 559 (47.5%) visited their cluster trial clinic within 6 mo. In the intervention arm, 89% (194/218) initiated ART within 3 mo of their first clinic visit. In the control arm, 42.3% (83/196) had a CD4 count ≤ 350 cells/μl at first visit, of whom 92.8% initiated ART within 3 mo. Regarding attitudes about ART, 93% (8,802/9,460) of participants agreed with the statement that they would want to start ART as soon as possible if HIV-positive. Estimated baseline HIV prevalence was 30.5% (2,028/6,656) (95% CI 25.0%, 37.0%). HIV prevalence, uptake of home-based HIV testing, linkage to care within 6 mo, and initiation of ART within 3 mo in those with CD4 count ≤ 350 cells/μl did not differ significantly between the intervention and control clusters. Selection bias related to noncontact could not be entirely excluded. Home-based HIV testing was well received in this rural population, although men were less easily contactable at home; immediate ART was acceptable, with good viral suppression and retention. However, only about half of HIV-positive people accessed care within 6 mo of being identified, with nearly two-thirds accessing care by 12 mo. The observed delay in linkage to care would limit the individual and public health ART benefits of universal testing and treatment in this population. ClinicalTrials.gov NCT01509508.

Community involvement in dengue vector control: cluster randomised trial.

PubMed

Vanlerberghe, V; Toledo, M E; Rodríguez, M; Gómez, D; Baly, A; Benítez, J R; Van der Stuyft, P

2010-01-01

To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Design Cluster randomised trial. Setting Guantanamo, Cuba. Participants 32 circumscriptions (around 2000 inhabitants each). Interventions The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selective adulticiding, and health education) and to intervention clusters (n=16) comprising the routine Aedes control programme combined with a community based environmental management approach. The primary outcome was levels of Aedes infestation: house index (number of houses positive for at least one container with immature stages of Ae aegypti per 100 inspected houses), Breteau index (number of containers positive for immature stages of Ae aegypti per 100 inspected houses), and the pupae per inhabitant statistic (number of Ae aegypti pupae per inhabitant). All clusters were subjected to the intended intervention; all completed the study protocol up to February 2006 and all were included in the analysis. At baseline the Aedes infestation levels were comparable between intervention and control clusters: house index 0.25% v 0.20%, pupae per inhabitant 0.44 x 10(-3) v 0.29 x 10(-3). At the end of the intervention these indices were significantly lower in the intervention clusters: rate ratio for house indices 0.49 (95% confidence interval 0.27 to 0.88) and rate ratio for pupae per inhabitant 0.27 (0.09 to 0.76). A community based environmental management embedded in a routine control programme was effective at reducing levels of Aedes infestation. Trial Registration Current Controlled Trials ISRCTN88405796.

The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

PubMed Central

2013-01-01

Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

Acute effects of a single exercise class on appetite, energy intake and mood. Is there a time of day effect?

PubMed

Maraki, M; Tsofliou, F; Pitsiladis, Y P; Malkova, D; Mutrie, N; Higgins, S

2005-12-01

This study aimed to investigate the acute effects of a single exercise class on appetite sensations, energy intake and mood, and to determine if there was a time of day effect. Twelve healthy, young, normal weight females, who were non-regular exercisers, participated in four trials: morning control, morning exercise, evening control and evening exercise. Exercise trials were a one-hour class of aerobic and muscle conditioning exercise of varying intensities, to music. Control trials were a one-hour rest. Ratings of perceived exertion were significantly greater during the warm-up and muscle conditioning parts of the morning exercise trial compared to those of the evening exercise trial. Although both exercise trials, compared to control trials, produced an increase in appetite sensations, they did not alter energy intake and produced a decrease in 'relative' energy intake. In relation to mood, both exercise trials increased positive affect and decreased negative affect. These results suggest that a single exercise class, representative of that offered by many sports centres, regardless of whether it is performed in the morning or evening produces a short-term negative energy balance and improves mood in normal weight women. However, when this type of exercise was performed in the morning it was perceived to require more effort.

Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial.

PubMed

Müller, Rachel; Gertz, Kevin J; Molton, Ivan R; Terrill, Alexandra L; Bombardier, Charles H; Ehde, Dawn M; Jensen, Mark P

2016-01-01

To determine the feasibility, acceptability, and efficacy of a computer-based positive psychology intervention in individuals with a physical disability and chronic pain. Individuals with spinal cord injury, multiple sclerosis, neuromuscular disease, or postpolio syndrome and chronic pain were randomly assigned to a positive psychology or a control condition. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises. Participants in the control group were instructed to write about life details for 8 weeks. Participants completed online well-being and pain-related questionnaires at baseline, posttreatment, and at the 2.5-month follow-up, and rated treatment satisfaction at posttreatment. Ninety-six participants were randomized and 68 (70%) completed follow-up assessments. Participants in the positive psychology intervention group reported significant pretreatment to posttreatment improvements in pain intensity, pain control, pain catastrophizing, pain interference, life satisfaction, positive affect, and depression. Improvements in life satisfaction, depression, pain intensity, pain interference, and pain control were maintained to the 2.5-month follow-up. Participants in the control group reported significant pretreatment to posttreatment improvements in life satisfaction, and pretreatment to follow-up improvements in pain intensity and pain control. Significant between-group differences, favoring the treatment group, emerged for pretreatment to posttreatment improvements in pain intensity and pain control. Participants were similarly satisfied with both treatments. The results support the feasibility, acceptability, and potential efficacy of a computer-based positive psychology intervention for improving well-being and pain-related outcomes in individuals with physical disabilities and chronic pain, and indicate that a full trial of the intervention is warranted.

A P300-based Brain-Computer Interface with Stimuli on Moving Objects: Four-Session Single-Trial and Triple-Trial Tests with a Game-Like Task Design

PubMed Central

Ganin, Ilya P.; Shishkin, Sergei L.; Kaplan, Alexander Y.

2013-01-01

Brain-computer interfaces (BCIs) are tools for controlling computers and other devices without using muscular activity, employing user-controlled variations in signals recorded from the user’s brain. One of the most efficient noninvasive BCIs is based on the P300 wave of the brain’s response to stimuli and is therefore referred to as the P300 BCI. Many modifications of this BCI have been proposed to further improve the BCI’s characteristics or to better adapt the BCI to various applications. However, in the original P300 BCI and in all of its modifications, the spatial positions of stimuli were fixed relative to each other, which can impose constraints on designing applications controlled by this BCI. We designed and tested a P300 BCI with stimuli presented on objects that were freely moving on a screen at a speed of 5.4°/s. Healthy participants practiced a game-like task with this BCI in either single-trial or triple-trial mode within four sessions. At each step, the participants were required to select one of nine moving objects. The mean online accuracy of BCI-based selection was 81% in the triple-trial mode and 65% in the single-trial mode. A relatively high P300 amplitude was observed in response to targets in most participants. Self-rated interest in the task was high and stable over the four sessions (the medians in the 1st/4th sessions were 79/84% and 76/71% in the groups practicing in the single-trial and triple-trial modes, respectively). We conclude that the movement of stimulus positions relative to each other may not prevent the efficient use of the P300 BCI by people controlling their gaze, e.g., in robotic devices and in video games. PMID:24302977

A Pilot RCT of Psychodynamic Group Art Therapy for Patients in Acute Psychotic Episodes: Feasibility, Impact on Symptoms and Mentalising Capacity

PubMed Central

Montag, Christiane; Haase, Laura; Seidel, Dorothea; Bayerl, Martin; Gallinat, Jürgen; Herrmann, Uwe; Dannecker, Karin

2014-01-01

This pilot study aimed to evaluate the feasibility of an assessor-blind, randomised controlled trial of psychodynamic art therapy for the treatment of patients with schizophrenia, and to generate preliminary data on the efficacy of this intervention during acute psychotic episodes. Fifty-eight inpatients with DSM-diagnoses of schizophrenia were randomised to either 12 twice-weekly sessions of psychodynamic group art therapy plus treatment as usual or to standard treatment alone. Primary outcome criteria were positive and negative psychotic and depressive symptoms as well as global assessment of functioning. Secondary outcomes were mentalising function, estimated with the Reading the mind in the eyes test and the Levels of emotional awareness scale, self-efficacy, locus of control, quality of life and satisfaction with care. Assessments were made at baseline, at post-treatment and at 12 weeks' follow-up. At 12 weeks, 55% of patients randomised to art therapy, and 66% of patients receiving treatment as usual were examined. In the per-protocol sample, art therapy was associated with a significantly greater mean reduction of positive symptoms and improved psychosocial functioning at post-treatment and follow-up, and with a greater mean reduction of negative symptoms at follow-up compared to standard treatment. The significant reduction of positive symptoms at post-treatment was maintained in an attempted intention-to-treat analysis. There were no group differences regarding depressive symptoms. Of secondary outcome parameters, patients in the art therapy group showed a significant improvement in levels of emotional awareness, and particularly in their ability to reflect about others' emotional mental states. This is one of the first randomised controlled trials on psychodynamic group art therapy for patients with acute psychotic episodes receiving hospital treatment. Results prove the feasibility of trials on art therapy during acute psychotic episodes and justify further research to substantiate preliminary positive results regarding symptom reduction and the recovery of mentalising function. Trial Registration ClinicalTrials.gov NCT01622166 PMID:25393414

Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong

PubMed Central

Ho, Henry C. Y.; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M.; Yew, Carol; Lam, Tai Hing; Chan, Sophia S.

2016-01-01

Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275). PMID:27199864

Noninvasive ventilation.

PubMed

Rabatin, J T; Gay, P C

1999-08-01

Noninvasive ventilation refers to the delivery of assisted ventilatory support without the use of an endotracheal tube. Noninvasive positive pressure ventilation (NPPV) can be delivered by using a volume-controlled ventilator, a pressure-controlled ventilator, a bilevel positive airway pressure ventilator, or a continuous positive airway pressure device. During the past decade, there has been a resurgence in the use of noninvasive ventilation, fueled by advances in technology and clinical trials evaluating its use. Several manufacturers produce portable devices that are simple to operate. This review describes the equipment, techniques, and complications associated with NPPV and also the indications for both short-term and long-term applications. NPPV clearly represents an important addition to the techniques available to manage patients with respiratory failure. Future clinical trials evaluating its many clinical applications will help to define populations of patients most apt to benefit from this type of treatment.

Phase II trial of CH5424802 (alectinib hydrochloride) for recurrent or refractory ALK-positive anaplastic large cell lymphoma: study protocol for a non-randomized non-controlled trial.

PubMed

Nagai, Hirokazu; Fukano, Reiji; Sekimizu, Masahiro; Kada, Akiko; M Saito, Akiko; Asada, Ryuta; Mori, Tetsuya

2017-08-01

Currently, a standard therapy has not been established for recurrent or refractory anaplastic lymphoma kinase-positive anaplastic large cell lymphoma. While there are many treatment options, such as hematopoietic stem cell transplantation, patients with resistant disease to conventional chemotherapies have particularly poor prognosis. There is urgent need to develop new drugs because of the lack of a standard therapy and poor prognoses. This phase II trial is designed for evaluating the efficacy and safety of alectinib hydrochloride for patients with recurrent or refractory anaplastic lymphoma kinase -positive anaplastic large cell lymphoma. The primary endpoint is the response rate according to the Revised Response Criteria for Malignant Lymphoma. The secondary endpoints are pharmacokinetics, safety in children, complete response rate, response duration, progression-free survival, event-free survival, overall survival, and adverse events. The results of this trial will be the pivotal data for the drug approval of alectinib hydrochloride for recurrent or refractory anaplastic lymphoma kinase-positive anaplastic large cell lymphoma.

Meta-analysis of the effects of repetitive transcranial magnetic stimulation (rTMS) on negative and positive symptoms in schizophrenia

PubMed Central

Freitas, Catarina; Fregni, Felipe; Pascual-Leone, Alvaro

2009-01-01

Background A growing body of evidence suggests that repetitive transcranial magnetic stimulation (rTMS) can alleviate negative and positive symptoms of refractory schizophrenia. However, trials to date have been small and results are mixed. Methods We performed meta-analyses of all prospective studies of the therapeutic application of rTMS in refractory schizophrenia assessing the effects of high-frequency rTMS to the left dorsolateral prefrontal cortex (DLPFC) to treat negative symptoms, and low-frequency rTMS to the left temporo-parietal cortex (TPC) to treat auditory hallucinations (AH) and overall positive symptoms. Results When analyzing controlled (active arms) and uncontrolled studies together, the effect sizes showed significant and moderate effects of rTMS on negative and positive symptoms (based on PANSS-N or SANS, and PANSS-P or SAPS, respectively). However, the analysis for the sham-controlled studies revealed a small non-significant effect size for negative (0.27, p=0.417) and for positive symptoms (0.17, p=0.129). When specifically analyzing AH (based on AHRS, HCS or SAH), the effect size for the sham-controlled studies was large and significant (1.04; p=0.002). Conclusions These meta-analyses support the need for further controlled, larger trials to assess the clinical efficacy of rTMS on negative and positive symptoms of schizophrenia, while suggesting the need for exploration for alternative stimulation protocols. PMID:19138833

Pacing for neurally mediated syncope: is placebo powerless?

PubMed

Brignole, M; Sutton, R

2007-01-01

After two recent controlled trials failed to prove superiority of cardiac pacing over placebo in patients affected by neurally mediated syncope, a widely accepted opinion is that cardiac pacing therapy is not very effective and that a strong placebo effect exists. To measure the effect of placebo pacing therapy. We compared the recurrence rate of syncope during placebo vs. no treatment in controlled trials of drug or pacing therapy. Syncope recurred in 38% of 252 patients randomized to placebo pooled from five trials vs. 34% of 881 patients randomized to no treatment pooled from eight trials. The corresponding recurrence rate with active cardiac pacing was 15% in 203 patients from six trials. Placebo is not an effective therapy for neurally mediated syncope. Different selection criteria in patients who are candidates for cardiac pacing-for example, presence, absence, or severity of the cardioinhibitory reflex may separate positive from negative trials.

Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

PubMed Central

2013-01-01

Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed. PMID:23336848

Just-in-Time Information Improved Decision-Making in Primary Care: A Randomized Controlled Trial

PubMed Central

McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

2008-01-01

Background The “Just-in-time Information” (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. Methods and Finding A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. Conclusions In this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action. Trial Registration Controlled-Trials.com ISRCTN96823810 PMID:19023446

Sleep positioning systems for children with cerebral palsy.

PubMed

Blake, Sharon F; Logan, Stuart; Humphreys, Ginny; Matthews, Justin; Rogers, Morwenna; Thompson-Coon, Joanna; Wyatt, Katrina; Morris, Christopher

2015-01-01

Sleep positioning systems can be prescribed for children with cerebral palsy to help reduce or prevent hip migration, provide comfort to ease pain and/or improve sleep. As sleep disturbance is common in children with developmental disabilities, with impact on their carers' sleep, and as sleep positioning systems can be expensive, guidance is needed to support decisions as to their use. To determine whether commercially-available sleep positioning systems, compared with usual care, reduce or prevent hip migration in children with cerebral palsy. Any negative effect of sleep positioning systems on hip migration will be considered within this objective.Secondary objectives were to determine the effect of sleep positioning systems on: (1) number or frequency of hip problems; (2) sleep patterns and quality; (3) quality of life of the child and family; (4) pain; and (5) physical functioning. We also sought to identify any adverse effects from using sleep positioning systems. In December 2014, we searched CENTRAL, Ovid MEDLINE, Embase, and 13 other databases. We also searched two trials registers. We applied no restrictions on date of publication, language, publication status or study design. We checked references and contacted manufacturers and authors for potentially relevant literature, and searched the internet using Google. We included all randomised controlled trials (RCTs) evaluating whole body sleep positioning systems for children and adolescents (up to 18 years of age) with cerebral palsy. Two review authors independently screened reports retrieved from the search against pre-determined inclusion criteria and assessed the quality of eligible studies.Members of the public (parent carers of children with neurodisability) contributed to this review by suggesting the topic, refining the research objectives, interpreting the findings, and reviewing the plain language summary. We did not identify any randomised controlled trials that evaluated the effectiveness of sleep positioning systems on hip migration.We did find two randomised cross-over trials that met the inclusion criteria in respect of secondary objectives relating to sleep quality and pain. Neither study reported any important difference between sleeping in sleep positioning systems and not for sleep patterns or sleep quality (two studies, 21 children, very low quality evidence) and pain (one study, 11 children, very low quality evidence). These were small studies with established users of sleep positioning systems and were judged to have high risk of bias.We found no eligible trials that explored the other secondary objectives (number or frequency of hip problems, quality of life of the child and family, physical functioning, and adverse effects). We found no randomised trials that evaluated the effectiveness of sleep positioning systems to reduce or prevent hip migration in children with cerebral palsy. Nor did we find any randomised trials that evaluated the effect of sleep positioning systems on the number or frequency of hip problems, quality of life of the child and family or on physical functioning.Limited data from two randomised trials, which evaluated the effectiveness of sleep positioning systems on sleep quality and pain for children with cerebral palsy, showed no significant differences in these aspects of health when children were using and not using a sleep positioning system.In order to inform clinical decision-making and the prescription of sleep positioning systems, more rigorous research is needed to determine effectiveness, cost-effectiveness, and the likelihood of adverse effects.

A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

PubMed

Lowther, Keira; Higginson, Irene J; Simms, Victoria; Gikaara, Nancy; Ahmed, Aabid; Ali, Zipporah; Afuande, Gaudencia; Kariuki, Hellen; Sherr, Lorraine; Jenkins, Rachel; Selman, Lucy; Harding, Richard

2014-09-03

Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown. A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%). The quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area. Clinicaltrials.gov NCT01608802.

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

PubMed Central

2013-01-01

Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. Methods/design The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Discussion Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Trial registration Number Dutch Trial registration (Nederlands Trial Register): NTR3437 PMID:23855591

Effect of Continuous Positive Airway Pressure on Stroke Rehabilitation: A Pilot Randomized Sham-Controlled Trial

PubMed Central

Khot, Sandeep P.; Davis, Arielle P.; Crane, Deborah A.; Tanzi, Patricia M.; Li Lue, Denise; Claflin, Edward S.; Becker, Kyra J.; Longstreth, W.T.; Watson, Nathaniel F.; Billings, Martha E.

2016-01-01

Study Objectives: Obstructive sleep apnea (OSA) predicts poor functional outcome after stroke and increases the risk for recurrent stroke. Less is known about continuous positive airway pressure (CPAP) treatment on stroke recovery. Methods: In a pilot randomized, double-blind, sham-controlled trial, adult stroke rehabilitation patients were assigned to auto-titrating or sham CPAP without diagnostic testing for OSA. Change in Functional Independence Measure (FIM), a measure of disability, was assessed between rehabilitation admission and discharge. Results: Over 18 months, 40 patients were enrolled and 10 withdrew from the study: 7 from active and 3 from sham CPAP (p > 0.10). For the remaining 30 patients, median duration of CPAP use was 14 days. Average CPAP use was 3.7 h/night, with at least 4 h nightly use among 15 patients. Adherence was not influenced by treatment assignment or stroke severity. In intention-to-treat analyses (n = 40), the median change in FIM favored active CPAP over sham but did not reach statistical significance (34 versus 26, p = 0.25), except for the cognitive component (6 versus 2.5, p = 0.04). The on-treatment analyses (n = 30) yielded similar results (total FIM: 32 versus 26, p = 0.11; cognitive FIM: 6 versus 2, p = 0.06). Conclusions: A sham-controlled CPAP trial among stroke rehabilitation patients was feasible in terms of recruitment, treatment without diagnostic testing and adequate blinding—though was limited by study retention and CPAP adherence. Despite these limitations, a trend towards a benefit of CPAP on recovery was evident. Tolerance and adherence must be improved before the full benefits of CPAP on recovery can be assessed in larger trials. Citation: Khot SP, Davis AP, Crane DA, Tanzi PM, Li Lue D, Claflin ES, Becker KJ, Longstreth WT, Watson NF, Billings ME. Effect of continuous positive airway pressure on stroke rehabilitation: a pilot randomized sham-controlled trial. J Clin Sleep Med 2016;12(7):1019–1026. PMID:27092703

Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV

PubMed Central

Moskowitz, Judith T.; Carrico, Adam W.; Duncan, Larissa G.; Cohn, Michael A.; Cheung, Elaine O.; Batchelder, Abigail; Martinez, Lizet; Segawa, Eisuke; Acree, Michael; Folkman, Susan

2017-01-01

Objective We conducted a randomized controlled trial to determine whether IRISS (Intervention for those Recently Informed of their Seropositive Status), a positive affect skills intervention, improved positive emotion, psychological health, physical health, and health behaviors in people newly diagnosed with HIV. Method 159 participants who had received an HIV diagnosis in the past 3 months were randomized to a 5-session, in-person, individually-delivered positive affect skills intervention or an attention-matched control condition. Results For the primary outcome of positive affect, the group difference in change from baseline over time did not reach statistical significance (p = .12; d = .30). Planned secondary analyses within assessment point showed that the intervention led to higher levels of past-day positive affect at 5, 10, and 15 months post diagnosis compared to an attention control. For antidepressant use, the between group difference in change from baseline was statistically significant (p = .006; d = −.78 baseline to 15 months) and the difference in change over time for intrusive and avoidant thoughts related to HIV was also statistically significant (p = .048; d = .29). Contrary to findings for most health behavior interventions in which effects wane over the follow up period, effect sizes in IRISS seemed to increase over time for most outcomes. Conclusions This comparatively brief positive affect skills intervention achieved modest improvements in psychological health, and may have the potential to support adjustment to a new HIV diagnosis. PMID:28333512

Effectiveness of liaison psychiatric nursing in older medical inpatients with depression: a randomised controlled trial.

PubMed

Cullum, Sarah; Tucker, Sue; Todd, Chris; Brayne, Carol

2007-07-01

To compare liaison psychiatric nursing with usual medical care in the management of older medical inpatients who screen positive for depression. Pragmatic randomised controlled trial. Medical wards of UK district general hospital in rural East Anglia. One hundred and thirty-eight medical inpatients aged 65+ screened positive on the 15-item geriatric depression scale (GDS). One hundred and twenty-one out of 138 screen positives entered the trial (58/121 fulfilled criteria for depressive disorder at baseline). (i) A liaison psychiatric nurse assessed participants, formulated a care plan for treatment of their depression, ensured its implementation through liaison with appropriate agencies, and monitored participants' mood and response to treatment for up to 12 weeks. (ii) Usual treatment by hospital and primary care staff. ICD-10 depressive disorder, change in GDS-15 score, quality-adjusted life weeks (QALWs) and patient satisfaction rating. Eighty-six out of 121 participants completed the 16-week trial. Participants in the intervention group were more satisfied with their care, but no significant differences in depressive disorder, depression rating or QALWs gained were found between groups. However, there was a trend towards improvement in the intervention group and effect sizes were higher in the subgroup with depressive disorder. This study is the first RCT to evaluate liaison psychiatric nursing specifically for depression in older medical inpatients; the findings suggest improvement in mental health and quality of life, but a larger trial is required to provide convincing evidence.

Evidence for the impact of quality improvement collaboratives: systematic review

PubMed Central

2008-01-01

Objective To evaluate the effectiveness of quality improvement collaboratives in improving the quality of care. Data sources Relevant studies through Medline, Embase, PsycINFO, CINAHL, and Cochrane databases. Study selection Two reviewers independently extracted data on topics, participants, setting, study design, and outcomes. Data synthesis Of 1104 articles identified, 72 were included in the study. Twelve reports representing nine studies (including two randomised controlled trials) used a controlled design to measure the effects of the quality improvement collaborative intervention on care processes or outcomes of care. Systematic review of these nine studies showed moderate positive results. Seven studies (including one randomised controlled trial) reported an effect on some of the selected outcome measures. Two studies (including one randomised controlled trial) did not show any significant effect. Conclusions The evidence underlying quality improvement collaboratives is positive but limited and the effects cannot be predicted with great certainty. Considering that quality improvement collaboratives seem to play a key part in current strategies focused on accelerating improvement, but may have only modest effects on outcomes at best, further knowledge of the basic components effectiveness, cost effectiveness, and success factors is crucial to determine the value of quality improvement collaboratives. PMID:18577559

Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background We have developed a new paradigm that targets the recognition of facial expression of emotions. Here we report the protocol of a randomised controlled trial of the effects of emotion recognition training on mood in a sample of individuals with depressive symptoms over a 6-week follow-up period. Methods/Design We will recruit 190 adults from the general population who report high levels of depressive symptoms (defined as a score ≥ 14 on the Beck Depression Inventory-II). Participants will attend a screening session and will be randomised to intervention or control procedures, repeated five times over consecutive days (Monday to Friday). A follow-up session will take place at end-of -treatment, 2-weeks and 6-weeks after training. Our primary study outcome will be depressive symptoms, Beck Depression Inventory- II (rated over the past two weeks). Our secondary outcomes are: depressive symptoms, Hamilton Rating Scale for Depression; anxiety symptoms, Beck Anxiety Inventory (rated over the past month); positive affect, Positive and Negative Affect Schedule (rated as ‘how you feel right now’); negative affect, Positive and Negative Affect Schedule (rated as ‘how you feel right now’); emotion sensitivity, Emotion Recognition Task (test phase); approach motivation and persistence, the Fishing Game; and depressive interpretation bias, Scrambled Sentences Test. Discussion This study is of a novel cognitive bias modification technique that targets biases in emotional processing characteristic of depression, and can be delivered automatically via computer, Internet or Smartphone. It therefore has potential to be a valuable cost-effective adjunctive treatment for depression which may be used together with more traditional psychotherapy, cognitive-behavioural therapy and pharmacotherapy. Trial registration Current Controlled Trials: ISRCTN17767674 PMID:23725208

Affective responses in mountain hiking—A randomized crossover trial focusing on differences between indoor and outdoor activity

PubMed Central

Einwanger, Jürgen; Hartl, Arnulf; Kopp, Martin

2017-01-01

Introduction Affective responses during physical activity (PA) are important for engagement in PA programs and for adherence to a physically active lifestyle. Little is known about the affective responses to PA bouts lasting longer than 45 minutes. Therefore, the aims of the present study were to analyse acute effects on affective responses of a three-hour outdoor PA intervention (mountain hiking) compared to a sedentary control situation and to an indoor treadmill condition. Methods Using a randomized crossover design, 42 healthy participants were randomly exposed to three different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary control situation (approximately three hours each). Measures included the Feeling Scale, Felt Arousal Scale and a Mood Survey Scale. Repeated measures ANOVAs were used to analyse differences between the conditions. Results Compared to the control situation, the participants showed a significant increase in affective valence (d = 1.21, p < .001), activation (d = 0.81, p = .004), elation (d = 1.07, p < .001), and calmness (d = 0.84, p = .004), and a significant decrease in fatigue (d = -1.19, p < .001) and anxiety (d = -.79, p < .001) after mountain hiking. Outdoor mountain hiking showed significantly greater positive effects on affective valence, activation, and fatigue compared to indoor treadmill walking. Discussion The results indicate that a three-hour PA intervention (mountain hiking) elicits higher positive and lower negative affective responses compared to a sedentary control situation and to an indoor PA condition. Outdoor mountain hiking can be recommended by health professionals as a form of PA with the potential to positively influence affective responses. Trial registration ClinicalTrials.gov NCT02853760. https://clinicaltrials.gov/. Date of registration: 08/02/2016 (retrospectively registered). Date of enrolment of the first participant to the trial: 05/01/2014. PMID:28520774

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Is reflexology an effective intervention? A systematic review of randomised controlled trials.

PubMed

Ernst, Edzard

2009-09-07

To evaluate the evidence for and against the effectiveness of reflexology for treating any medical condition. Six electronic databases were searched from their inception to February 2009 to identify all relevant randomised controlled trials (RCTs). No language restrictions were applied. RCTs of reflexology delivered by trained reflexologists to patients with specific medical conditions. Condition studied, study design and controls, primary outcome measures, follow-up, and main results were extracted. 18 RCTs met all the inclusion criteria. The studies examined a range of conditions: anovulation, asthma, back pain, dementia, diabetes, cancer, foot oedema in pregnancy, headache, irritable bowel syndrome, menopause, multiple sclerosis, the postoperative state and premenstrual syndrome. There were > 1 studies for asthma, the postoperative state, cancer palliation and multiple sclerosis. Five RCTs yielded positive results. Methodological quality was evaluated using the Jadad scale. The methodological quality was often poor, and sample sizes were generally low. Most higher-quality trials did not generate positive findings. The best evidence available to date does not demonstrate convincingly that reflexology is an effective treatment for any medical condition.

Ethical Issues for Control-Arm Patients After Revelation of Benefits of Experimental Therapy: A Framework Modeled in Neuroblastoma

PubMed Central

Unguru, Yoram; Joffe, Steven; Fernandez, Conrad V.; Yu, Alice L.

2013-01-01

In 2009, the Children's Oncology Group (COG) phase III randomized controlled trial, ANBL0032, found that adding immunotherapy (Ch14.18) to standard therapy significantly improved outcomes in patients with high-risk neuroblastoma when administered within 110 days after autologous stem-cell transplantation (SCT). After careful deliberation and consultation, the COG Neuroblastoma Committee decided to offer Ch14.18 to prior trial participants who had been randomly assigned to the control arm (no immunotherapy), regardless of the time that had elapsed since SCT. This decision occurred in the context of a limited supply of Ch14.18 and no data regarding its role when administered beyond 110 days. In this article, we analyze the numerous ethical challenges highlighted by the ANBL0032 trial, including the limits of researchers' reciprocity-based obligations to study participants, post-trial access to beneficial therapies, and the balance between scientific knowledge and parental hope. These deliberations may be useful to other researchers when considering their ethical obligations to control-arm participants in the wake of a positive randomized trial. PMID:23295797

Effect of periodontal treatment on preterm birth rate: a systematic review of meta-analyses.

PubMed

López, Néstor J; Uribe, Sergio; Martinez, Benjamín

2015-02-01

Preterm birth is a major cause of neonatal morbidity and mortality in both developed and developing countries. Preterm birth is a highly complex syndrome that includes distinct clinical subtypes in which many different causes may be involved. The results of epidemiological, molecular, microbiological and animal-model studies support a positive association between maternal periodontal disease and preterm birth. However, the results of intervention studies carried out to determine the effect of periodontal treatment on reducing the risk of preterm birth are controversial. This systematic review critically analyzes the methodological issues of meta-analyses of the studies to determine the effect of periodontal treatment to reduce preterm birth. The quality of the individual randomized clinical trials selected is of highest relevance for a systematic review. This article describes the methodological features that should be identified a priori and assessed individually to determine the quality of a randomized controlled trial performed to evaluate the effect of periodontal treatment on pregnancy outcomes. The AMSTAR and the PRISMA checklist tools were used to assess the quality of the six meta-analyses selected, and the bias domain of the Cochrane Collaboration's Tool was applied to evaluate each of the trials included in the meta-analyses. In addition, the methodological characteristics of each clinical trial were assessed. The majority of the trials included in the meta-analyses have significant methodological flaws that threaten their internal validity. The lack of effect of periodontal treatment on preterm birth rate concluded by four meta-analyses, and the positive effect of treatment for reducing preterm birth risk concluded by the remaining two meta-analyses are not based on consistent scientific evidence. Well-conducted randomized controlled trials using rigorous methodology, including appropriate definition of the exposure, adequate control of confounders for preterm birth and application of effective periodontal interventions to eliminate periodontal infection, are needed to confirm the positive association between periodontal disease and preterm birth. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand

PubMed Central

Simmons, Nicole; Donnell, Deborah; Ou, San-san; Celentano, David D.; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

2015-01-01

Context Controlled trials of educational interventions are susceptible to contamination. Objectives To test a contamination measure based on recall of terms. Main study A randomized controlled trial of a social network peer education intervention among 1,123 injection drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand. Methods We assessed the recall of test, negative and positive control terms by intervention and control arm participants and compared the relative odds (OR) of recall of test vs. negative control terms between study arms. Results The contamination measure showed good discriminant ability only among participants from Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was evidence of diffusion and contamination of 4 of 5 terms tested. Conclusions Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in trials of educational interventions. PMID:25935214

Community involvement in dengue vector control: cluster randomised trial

PubMed Central

Toledo, M E; Rodríguez, M; Gomez, D; Baly, A; Benitez, J R; Van der Stuyft, P

2009-01-01

Objective To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Design Cluster randomised trial. Setting Guantanamo, Cuba. Participants 32 circumscriptions (around 2000 inhabitants each). Interventions The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selective adulticiding, and health education) and to intervention clusters (n=16) comprising the routine Aedes control programme combined with a community based environmental management approach. Main outcome measures The primary outcome was levels of Aedes infestation: house index (number of houses positive for at least one container with immature stages of Ae aegypti per 100 inspected houses), Breteau index (number of containers positive for immature stages of Ae aegypti per 100 inspected houses), and the pupae per inhabitant statistic (number of Ae aegypti pupae per inhabitant). Results All clusters were subjected to the intended intervention; all completed the study protocol up to February 2006 and all were included in the analysis. At baseline the Aedes infestation levels were comparable between intervention and control clusters: house index 0.25% v 0.20%, pupae per inhabitant 0.44×10−3 v 0.29×10−3. At the end of the intervention these indices were significantly lower in the intervention clusters: rate ratio for house indices 0.49 (95% confidence interval 0.27 to 0.88) and rate ratio for pupae per inhabitant 0.27 (0.09 to 0.76). Conclusion A community based environmental management embedded in a routine control programme was effective at reducing levels of Aedes infestation. Trial registration Current Controlled Trials ISRCTN88405796. PMID:19509031

Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery.

PubMed

Hemmes, Sabrine N T; Severgnini, Paolo; Jaber, Samir; Canet, Jaume; Wrigge, Hermann; Hiesmayr, Michael; Tschernko, Edda M; Hollmann, Markus W; Binnekade, Jan M; Hedenstierna, Göran; Putensen, Christian; de Abreu, Marcelo Gama; Pelosi, Paolo; Schultz, Marcus J

2011-05-06

Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication. The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. ISRCTN: ISRCTN70332574.

Effect of nutritional supplementation of breastfeeding HIV positive mothers on maternal and child health: findings from a randomized controlled clinical trial

PubMed Central

2011-01-01

Background It has been well established that breastfeeding is beneficial for child health, however there has been debate regarding the effect of lactation on maternal health in the presence of HIV infection and the need for nutritional supplementation in HIV positive lactating mothers. Aims To assess the effect of nutritional supplementation to HIV infected lactating mothers on nutritional and health status of mothers and their infants. Methods A randomized controlled clinical trial to study the impact of nutritional supplementation on breastfeeding mothers. Measurements included anthropometry; body composition indicators; CD4 count, haemoglobin and albumin; as well as incidence rates of opportunistic infections; depression and quality of life scores. Infant measurements included anthropometry, development and rates of infections. Results The supplement made no significant impact on any maternal or infant outcomes. However in the small group of mothers with low BMI, the intake of supplement was significantly associated with preventing loss of lean body mass (1.32 kg vs. 3.17 kg; p = 0.026). There was no significant impact of supplementation on the infants. Conclusions A 50 g daily nutritional supplement to breastfeeding mothers had no or limited effect on mother and child health outcomes. Clinical trial registration ISRCTN68128332 (http://www.controlled-trials.com/ISRCTN68128332) PMID:22192583

Effect of prolonged and exclusive breast feeding on risk of allergy and asthma: cluster randomised trial.

PubMed

Kramer, Michael S; Matush, Lidia; Vanilovich, Irina; Platt, Robert; Bogdanovich, Natalia; Sevkovskaya, Zinaida; Dzikovich, Irina; Shishko, Gyorgy; Mazer, Bruce

2007-10-20

To assess whether exclusive and prolonged breast feeding reduces the risk of childhood asthma and allergy by age 6.5 years. Cluster randomised trial. 31 Belarussian maternity hospitals and their affiliated polyclinics. A total of 17,046 mother-infant pairs were enrolled, of whom 13,889 (81.5%) were followed up at age 6.5 years. Breastfeeding promotion intervention modelled on the WHO/UNICEF baby friendly hospital initiative. International study of asthma and allergies in childhood (ISAAC) questionnaire and skin prick tests of five inhalant antigens. The experimental intervention led to a large increase in exclusive breast feeding at 3 months (44.3% v 6.4%; P<0.001) and a significantly higher prevalence of any breast feeding at all ages up to and including 12 months. The experimental group had no reduction in risks of allergic symptoms and diagnoses or positive skin prick tests. In fact, after exclusion of six sites (three experimental and three control) with suspiciously high rates of positive skin prick tests, risks were significantly increased in the experimental group for four of the five antigens. These results do not support a protective effect of prolonged and exclusive breast feeding on asthma or allergy. Current Controlled Trials ISRCTN37687716 [controlled-trials.com].

Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial.

PubMed

Williams, Alishia D; Blackwell, Simon E; Holmes, Emily A; Andrews, Gavin

2013-10-29

The current randomised controlled trial will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification (CBM) intervention for depression when compared with an active control condition and help establish the additive benefit of positive imagery CBM when delivered in combination with internet cognitive behavioural therapy for depression. Patients meeting diagnostic criteria for a current major depressive episode will be recruited through the research arm of a not-for-profit clinical and research unit in Australia. The minimum sample size for each group (α set at 0.05, power at 0.80) was identified as 29, but at least 10% more will be recruited to hedge against expected attrition. We will measure the impact of CBM on primary measures of depressive symptoms (Beck Depression Inventory-second edition (BDI-II), Patient Health Questionnaire (PHQ9)) and interpretive bias (ambiguous scenarios test-depression), and on a secondary measure of psychological distress (Kessler-10 (K10)) following the 1-week CBM intervention. Secondary outcome measures of psychological distress (K10), as well as disability (WHO disability assessment schedule-II), repetitive negative thinking (repetitive thinking questionnaire), and anxiety (state trait anxiety inventory-trait version) will be evaluated following completion of the 11-week combined intervention, in addition to the BDI-II and PHQ9. Intent-to-treat marginal and mixed effect models using restricted maximum likelihood estimation will be used to evaluate the primary hypotheses. Clinically significant change will be defined as high-end state functioning (a BDI-II score <14) combined with a total score reduction greater than the reliable change index score. Maintenance of gains will be assessed at 3-month follow-up. The current trial protocol has been approved by the Human Research Ethics Committee of St Vincent's Hospital and the University of New South Wales, Sydney. Australian New Zealand Clinical Trials Registry: ACTRN12613000139774 and Clinicaltrials.gov: NCT01787513. This trial protocol is written in compliance with the Standard Protocol Items: recommendations for Interventional Trials (SPIRIT) guidelines.

The face-specific proportion congruency effect: social stimuli as contextual cues.

PubMed

Jiménez-Moya, Gloria; Rodríguez-Bailón, Rosa; Lupiáñez, Juan

2018-06-18

Previous research shows that larger interference is observed in contexts associated with a high proportion of congruent trials than in those associated with a low proportion of congruent trials. Given that one of the most relevant contexts for human beings is social context, researchers have recently explored the possibility that social stimuli could also work as contextual cues for the allocation of attentional control. In fact, it has been shown that individuals use social categories (i.e., men and women) as cues to allocate attentional control. In this work, we go further by showing that individual faces (instead of the social categories they belong to) associated with a high proportion of congruent trials can also lead to larger interference effects compared to individual faces predicting a relatively low proportion of congruent trials. Furthermore, we show that faces associated with a high proportion of congruent trials are more positively evaluated than faces associated with a high proportion of incongruent trials. These results demonstrate that unique human faces are potential contextual cues than can be employed to apply cognitive control when performing an automatic task.

Effects of a behavioral intervention to reduce serodiscordant unsafe sex among HIV positive men who have sex with men: the Positive Connections randomized controlled trial study.

PubMed

Rosser, B R Simon; Hatfield, Laura A; Miner, Michael H; Ghiselli, Margherita E; Lee, Brian R; Welles, Seth L

2010-04-01

Few behavioral interventions have been conducted to reduce high-risk sexual behavior among HIV-positive Men who have Sex with Men (HIV+ MSM). Hence, we lack well-proven interventions for this population. Positive Connections is a randomized controlled trial (n = 675 HIV+ MSM) comparing the effects of two sexual health seminars--for HIV+ MSM and all MSM--with a contrast prevention video arm. Baseline, 6-, 12- and 18-month follow-up surveys assessed psychosexual variables and frequency of serodiscordant unprotected anal intercourse (SDUAI). At post-test, intentions to avoid transmission were significantly higher in the sexual health arms. However, SDUAI frequency decreased equally across arms. HIV+ MSM engaging in SDUAI at baseline were more likely to leave the study. Tailoring interventions to HIV+ MSM did not increase their effectiveness in this study. A sexual health approach appeared as effective as an untailored video-based HIV prevention intervention in reducing SDUAI among HIV+ MSM.

Hybrid Position/Force Control of an Active Handheld Micromanipulator for Membrane Peeling

PubMed Central

Wells, Trent S.; Yang, Sungwook; MacLachlan, Robert A.; Lobes, Louis A.; Martel, Joseph N.; Riviere, Cameron N.

2015-01-01

Background Peeling procedures in retinal surgery require micron-scale manipulation and control of sub-tactile forces. Methods Hybrid position/force control of an actuated handheld microsurgical instrument is presented as a means for simultaneously improving positioning accuracy and reducing forces to prevent avoidable trauma to tissue. The system response was evaluated, and membrane-peeling trials were performed by four test subjects in both artificial and animal models. Results Maximum force was reduced by 56% in both models as compared to position control. No statistically significant effect on procedure duration was observed. Conclusions A hybrid position/force control system has been implemented that successfully attenuates forces and minimizes unwanted excursions during microsurgical procedures such as membrane peeling. Results also suggest that improvements in safety using this technique may be attained without increasing the duration of the procedure. PMID:25962836

No pain, no gain: the affective valence of congruency conditions changes following a successful response.

PubMed

Schouppe, Nathalie; Braem, Senne; De Houwer, Jan; Silvetti, Massimo; Verguts, Tom; Ridderinkhof, K Richard; Notebaert, Wim

2015-03-01

The cognitive control theory of Botvinick, Cognitive, Affective, & Behavioral Neuroscience, 7, 356-366 (2007) integrates cognitive and affective control processes by emphasizing the aversive nature of cognitive conflict. Using an affective priming paradigm, we replicate earlier results showing that incongruent trials, relative to congruent trials, are indeed perceived as more aversive (Dreisbach & Fischer, Brain and Cognition, 78(2), 94-98 (2012)). Importantly, however, in two experiments we demonstrate that this effect is reversed following successful responses; correctly responding to incongruent trials engendered relatively more positive affect than correctly responding to congruent trials. The results are discussed in light of a recent computational model by Silvetti, Seurinck, and Verguts, Frontiers in Human Neuroscience, 5:75 (2011) where it is assumed that outcome expectancies are more negative for incongruent trials than congruent trials. Consequently, the intrinsic reward (prediction error) following successful completion is larger for incongruent than congruent trials. These findings divulge a novel perspective on 'cognitive' adaptations to conflict.

Dissociable neural mechanisms underlying response-based and familiarity-based conflict in working memory.

PubMed

Nelson, James K; Reuter-Lorenz, Patricia A; Sylvester, Ching-Yune C; Jonides, John; Smith, Edward E

2003-09-16

Cognitive control requires the resolution of interference among competing and potentially conflicting representations. Such conflict can emerge at different points between stimulus input and response generation, with the net effect being that of compromising performance. The goal of this article was to dissociate the neural mechanisms underlying different sources of conflict to elucidate the architecture of the neural systems that implement cognitive control. By using functional magnetic resonance imaging and a verbal working memory task (item recognition), we examined brain activity related to two kinds of conflict with comparable behavioral consequences. In a trial of our item-recognition task, participants saw four letters, followed by a retention interval, and a probe letter that did or did not match one of the letters held in working memory (positive probe and negative probe, respectively). On some trials, conflict arose solely because of the current negative probe having a high familiarity, due to its membership in the immediately preceding trial's target set. On other trials, additional conflict arose because of the current negative probe having also been a positive probe on the immediately preceding trial, producing response-level conflict. Consistent with previous work, conflict due to high familiarity was associated with left prefrontal activation, but not with anterior cingulate activation. The response-conflict condition, when compared with high-familiarity conflict trials, was associated with anterior cingulate cortex activation, but with no additional left prefrontal activation. This double dissociation points to differing contributions of specific cortical areas to cognitive control, which are based on the source of conflict.

Plasma-Generating Glucose Monitor Accuracy Demonstrated in an Animal Model

PubMed Central

Magarian, Peggy; Sterling, Bernhard

2009-01-01

Introduction Four randomized controlled trials have compared mortality and morbidity of tight glycemic control versus conventional glucose for intensive care unit (ICU) patients. Two trials showed a positive outcome. However, one single-center trial and a large multicenter trial had negative results. The positive trials used accurate portable lab analyzers. The negative trial allowed the use of meters. The portable analyzer measures in filtered plasma, minimizing the interference effects. OptiScan Biomedical Corporation is developing a continuous glucose monitor using centrifuged plasma and mid-infrared spectroscopy for use in ICU medicine. The OptiScanner draws approximately 0.1 ml of blood every 15 min and creates a centrifuged plasma sample. Internal quality control minimizes sample preparation error. Interference adjustment using this technique has been presented at the Society of Critical Care Medicine in separate studies since 2006. Method A good laboratory practice study was conducted on three Yorkshire pigs using a central venous catheter over 6 h while performing a glucose challenge. Matching Yellow Springs Instrument glucose readings were obtained. Results Some 95.7% of the predicted values were in the Clarke Error Grid A zone and 4.3% in the B zone. Of those in the B zone, all were within 3.3% of the A zone boundaries. The coefficient of determination (R2) was 0.993. The coefficient of variance was 5.02%. Animal necropsy and blood panels demonstrated safety. Conclusion The OptiScanner investigational device performed safely and accurately in an animal model. Human studies using the device will begin soon. PMID:20144396

Reactions to changes in work control: Implications for self-determined and non-self-determined individuals.

PubMed

Parker, Stacey L; Jimmieson, Nerina L; Amiot, Catherine E

2016-10-01

We investigate the extent to which individuals' global motivation (self-determined and non-self-determined types) influences adjustment (anxiety, positive reappraisal) and engagement (intrinsic motivation, task performance) in reaction to changes to the level of work control available during a work simulation. Participants (N = 156) completed 2 trials of an inbox activity under conditions of low or high work control-with the ordering of these levels varied to create an increase, decrease, or no change in work control. In support of the hypotheses, results revealed that for more self-determined individuals, high work control led to the increased use of positive reappraisal. Follow-up moderated mediation analyses revealed that the increases in positive reappraisal observed for self-determined individuals in the conditions in which work control was high by Trial 2 consequently increased their intrinsic motivation toward the task. For more non-self-determined individuals, high work control (as well as changes in work control) led to elevated anxiety. Follow-up moderated mediation analyses revealed that the increases in anxiety observed for non-self-determined individuals in the high-to-high work control condition consequently reduced their task performance. It is concluded that adjustment to a demanding work task depends on a fit between individuals' global motivation and the work control available, which has consequences for engagement with demanding work. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The evidence-practice gap in specialist mental healthcare: systematic review and meta-analysis of guideline implementation studies.

PubMed

Girlanda, Francesca; Fiedler, Ines; Becker, Thomas; Barbui, Corrado; Koesters, Markus

2017-01-01

Clinical practice guidelines are not easily implemented, leading to a gap between research synthesis and their use in routine care. To summarise the evidence relating to the impact of guideline implementation on provider performance and patient outcomes in mental healthcare settings, and to explore the performance of different strategies for guideline implementation. A systematic review of randomised controlled trials, controlled clinical trials and before-and-after studies comparing guideline implementation strategies v. usual care, and different guideline implementation strategies, in patients with severe mental illness. In total, 19 studies met our inclusion criteria. The studies did not show a consistent positive effect of guideline implementation on provider performance, but a more consistent small to modest positive effect on patient outcomes. Guideline implementation does not seem to have an impact on provider performance, nonetheless it may influence patient outcomes positively. © The Royal College of Psychiatrists 2017.

Implementation of an educational intervention to improve hand washing in primary schools: process evaluation within a randomised controlled trial.

PubMed

Chittleborough, Catherine R; Nicholson, Alexandra L; Young, Elaine; Bell, Sarah; Campbell, Rona

2013-08-15

Process evaluations are useful for understanding how interventions are implemented in trial settings. This is important for interpreting main trial results and indicating how the intervention might function beyond the trial. The purpose of this study was to examine the reach, dose, fidelity, acceptability, and sustainability of the implementation of an educational hand washing intervention in primary schools, and to explore views regarding acceptability and sustainability of the intervention. Process evaluation within a cluster randomised controlled trial, including focus groups with pupils aged 6 to 11, semi-structured interviews with teachers and external staff who coordinated the intervention delivery, and school reports and direct observations of the intervention delivery. The educational package was delivered in 61.4% of schools (85.2% of intervention schools, 37.8% of control schools following completion of the trial). Teachers and pupils reacted positively to the intervention, although concerns were raised about the age-appropriateness of the resources. Teachers adapted the resources to suit their school setting and pupils. Staff coordinating the intervention delivery had limited capacity to follow up and respond to schools. The hand washing intervention was acceptable to schools, but its reach outside of a randomised trial, evidenced in the low proportion of schools in the control arm who received it after the trial had ended, suggests that the model of delivery may not be sustainable. ISRCTN: ISRCTN93576146.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial

PubMed Central

2013-01-01

Background Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. Methods/Design In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. Discussion The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Trial registration Current Controlled Trials ISRCTN84216587 PMID:23317474

Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.

PubMed

Shang, Aijing; Huwiler-Müntener, Karin; Nartey, Linda; Jüni, Peter; Dörig, Stephan; Sterne, Jonathan A C; Pewsner, Daniel; Egger, Matthias

Homoeopathy is widely used, but specific effects of homoeopathic remedies seem implausible. Bias in the conduct and reporting of trials is a possible explanation for positive findings of trials of both homoeopathy and conventional medicine. We analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias. Placebo-controlled trials of homoeopathy were identified by a comprehensive literature search, which covered 19 electronic databases, reference lists of relevant papers, and contacts with experts. Trials in conventional medicine matched to homoeopathy trials for disorder and type of outcome were randomly selected from the Cochrane Controlled Trials Register (issue 1, 2003). Data were extracted in duplicate and outcomes coded so that odds ratios below 1 indicated benefit. Trials described as double-blind, with adequate randomisation, were assumed to be of higher methodological quality. Bias effects were examined in funnel plots and meta-regression models. 110 homoeopathy trials and 110 matched conventional-medicine trials were analysed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0.88 (95% CI 0.65-1.19) for homoeopathy (eight trials) and 0.58 (0.39-0.85) for conventional medicine (six trials). Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.

Prone positioning reduces mortality from acute respiratory distress syndrome in the low tidal volume era: a meta-analysis

PubMed Central

Shaefi, Shahzad; Montesi, Sydney B.; Devlin, Amy; Loring, Stephen H.; Talmor, Daniel; Malhotra, Atul

2014-01-01

Purpose Prone positioning for ARDS has been performed for decades without definitive evidence of clinical benefit. A recent multicenter trial demonstrated for the first time significantly reduced mortality with prone positioning. This meta-analysis was performed to integrate these findings with existing literature and test whether differences in tidal volume explain conflicting results among randomized trials. Methods Studies were identified using MEDLINE, EMBASE, Cochrane Register of Controlled Trials, LILACS, and citation review. Included were randomized trials evaluating the effect on mortality of prone versus supine positioning during conventional ventilation for ARDS. The primary outcome was risk ratio of death at 60 days meta-analyzed using random effects models. Analysis stratified by high (>8 ml/kg predicted body weight) or low (≤8 ml/kg PBW) mean baseline tidal volume was planned a priori. Results Seven trials were identified including 2,119 patients, of whom 1,088 received prone positioning. Overall, prone positioning was not significantly associated with the risk ratio of death (RR 0.83; 95 % CI 0.68–1.02; p = 0.073; I2 = 64 %). When stratified by high or low tidal volume, prone positioning was associated with a significant decrease in RR of death only among studies with low baseline tidal volume (RR 0.66; 95 % CI 0.50–0.86; p = 0.002; I2 = 25 %). Stratification by tidal volume explained over half the between-study heterogeneity observed in the unstratified analysis. Conclusions Prone positioning is associated with significantly reduced mortality from ARDS in the low tidal volume era. Substantial heterogeneity across studies can be explained by differences in tidal volume. PMID:24435203

Modified Reporting of Positive Urine Cultures to Reduce Inappropriate Treatment of Asymptomatic Bacteriuria Among Nonpregnant, Noncatheterized Inpatients: A Randomized Controlled Trial.

PubMed

Daley, Peter; Garcia, David; Inayatullah, Raheel; Penney, Carla; Boyd, Sarah

2018-05-28

DESIGNWe conducted a randomized, parallel, unblinded, superiority trial of a laboratory reporting intervention designed to reduce antibiotic treatment of asymptomatic bacteriuria (ASB).METHODSResults of positive urine cultures from 110 consecutive inpatients at 2 urban acute-care hospitals were randomized to standard report (control) or modified report (intervention). The standard report included bacterial count, bacterial identification, and antibiotic susceptibility information including drug dosage and cost. The modified report stated: "This POSITIVE urine culture may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory … for identification and susceptibility results." We used the following exclusion criteria: age <18 years, pregnancy, presence of an indwelling urinary catheter, samples from patients already on antibiotics, neutropenia, or admission to an intensive care unit. The primary efficacy outcome was the proportion of appropriate antibiotic therapy prescribed.RESULTSAccording to our intention-to-treat (ITT) analysis, the proportion of appropriate treatment (urinary tract infection treated plus ASB not treated) was higher in the modified arm than in the standard arm: 44 of 55 (80.0%) versus 29 of 55 (52.7%), respectively (absolute difference, -27.3%; RR, 0.42; P = .002; number needed to report for benefit, 3.7).CONCLUSIONSModified reporting resulted in a significant reduction in inappropriate antibiotic treatment without an increase in adverse events. Safety should be further assessed in a large effectiveness trial before implementationTRIAL REGISTRATION. clinicaltrials.gov#NCT02797613Infect Control Hosp Epidemiol 2018;1-6.

The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.

PubMed

Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

2013-07-29

In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Current Controlled Trials ISRCTN70202532.

The positive deviance/hearth approach to reducing child malnutrition: systematic review.

PubMed

Bisits Bullen, Piroska A

2011-11-01

The Positive Deviance/Hearth approach aims to rehabilitate malnourished children using practices from mothers in the community who have well-nourished children despite living in poverty. This study assesses its effectiveness in a range of settings. Systematic review of peer reviewed intervention trials and grey literature evaluation reports of child malnutrition programs using the Positive Deviance/Hearth approach. Ten peer reviewed studies and 14 grey literature reports met the inclusion criteria. These described results for 17 unique Positive Deviance/Hearth programs in 12 countries. Nine programs used a pre- and post-test design without a control, which limited the conclusions that could be drawn. Eight used more robust designs such as non-randomized trials, non-randomized cross-sectional sibling studies and randomized controlled trials (RCTs). Of the eight programs that reported nutritional outcomes, five reported some type of positive result in terms of nutritional status - although the improvement was not always as large as predicted, or across the entire target population. Both the two RCTs demonstrated improvements in carer feeding practices. Qualitative results unanimously reported high levels of satisfaction from participants and recipient communities. Overall this study shows mixed results in terms of program effectiveness, although some Positive Deviance/Hearth programs have clearly been successful in particular settings. Sibling studies suggest that the Positive Deviance/Hearth approach may have a role in preventing malnutrition, not just rehabilitation. Further research is needed using more robust study designs and larger sample sizes. Issues related to community participation and consistency in reporting results need to be addressed. © 2011 Blackwell Publishing Ltd.

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

PubMed

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P

2010-09-30

The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

Effects of a health education and telephone counseling program on patients with a positive fecal occult blood test result for colorectal cancer screening: A randomized controlled trial.

PubMed

Chiu, Hui-Chuan; Hung, Hsin-Yuan; Lin, Hsiu-Chen; Chen, Shu-Ching

2017-10-01

Our purpose was to evaluate the effects of a health education and telephone counseling program on knowledge and attitudes about colorectal cancer and screening and the psychological impact of positive screening results. A randomized controlled trial was conducted with 2 groups using a pretest and posttest measures design. Patients with positive colorectal cancer screening results were selected and randomly assigned to an experimental (n = 51) or control (n = 51) group. Subjects in the experimental group received a health education and telephone counseling program, while the control group received routine care only. Patients were assessed pretest before intervention (first visit to the outpatient) and posttest at 4 weeks after intervention (4 weeks after first visit to the outpatient). Patients in the experimental group had a significantly better level of knowledge about colorectal cancer and the psychological impact of a positive screening result than did the control group. Analysis of covariance revealed that the health education and telephone counseling program had a significant main effect on colorectal cancer knowledge. A health education and telephone counseling program can improve knowledge about colorectal cancer and about the psychological impact in patients with positive colorectal cancer screening results. The health education and telephone counseling program is an easy, simple, and convenient method of improving knowledge, improving attitudes, and alleviating psychological distress in patients with positive colorectal cancer screening results, and this program can be expanded to other types of cancer screening. Copyright © 2016 John Wiley & Sons, Ltd.

Individualized tracking of self-directed motor learning in group-housed mice performing a skilled lever positioning task in the home cage.

PubMed

Silasi, Gergely; Boyd, Jamie D; Bolanos, Federico; LeDue, Jeff M; Scott, Stephen H; Murphy, Timothy H

2018-01-01

Skilled forelimb function in mice is traditionally studied through behavioral paradigms that require extensive training by investigators and are limited by the number of trials individual animals are able to perform within a supervised session. We developed a skilled lever positioning task that mice can perform within their home cage. The task requires mice to use their forelimb to precisely hold a lever mounted on a rotary encoder within a rewarded position to dispense a water reward. A Raspberry Pi microcomputer is used to record lever position during trials and to control task parameters, thus making this low-footprint apparatus ideal for use within animal housing facilities. Custom Python software automatically increments task difficulty by requiring a longer hold duration, or a more accurate hold position, to dispense a reward. The performance of individual animals within group-housed mice is tracked through radio-frequency identification implants, and data stored on the microcomputer may be accessed remotely through an active internet connection. Mice continuously engage in the task for over 2.5 mo and perform ~500 trials/24 h. Mice required ~15,000 trials to learn to hold the lever within a 10° range for 1.5 s and were able to further refine movement accuracy by limiting their error to a 5° range within each trial. These results demonstrate the feasibility of autonomously training group-housed mice on a forelimb motor task. This paradigm may be used in the future to assess functional recovery after injury or cortical reorganization induced by self-directed motor learning. NEW & NOTEWORTHY We developed a low-cost system for fully autonomous training of group-housed mice on a forelimb motor task. We demonstrate the feasibility of tracking both end-point, as well as kinematic performance of individual mice, with each performing thousands of trials over 2.5 mo. The task is run and controlled by a Raspberry Pi microcomputer, which allows for cages to be monitored remotely through an active internet connection.

Can a documentary increase help-seeking intentions in men? A randomised controlled trial

PubMed Central

Schlichthorst, Marisa; Spittal, Matthew J; Phelps, Andrea; Pirkis, Jane

2018-01-01

Background We investigated whether a public health intervention—a three-part documentary called Man Up which explored the relationship between masculinity and mental health, well-being and suicidality—could increase men’s intentions to seek help for personal and emotional problems. Methods We recruited men aged 18 years or over who were not at risk of suicide to participate in a double-blind randomised controlled trial. Participants were randomly assigned (1:1) via computer randomisation to view Man Up (the intervention) or a control documentary. We hypothesised that 4 weeks after viewing Man Up participants would report higher levels of intention to seek help than those who viewed the control documentary. Our primary outcome was assessed using the General Help Seeking Questionnaire, and was analysed for all participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616001169437, Universal Trial Number: U1111-1186-1459) and was funded by the Movember Foundation. Results Three hundred and fifty-four men were assessed for eligibility for the trial and randomised to view Man Up or the control documentary. Of these, 337 completed all stages (nine participants were lost to follow-up in the intervention group and eight in the control group). Linear regression analysis showed a significant increase in intentions to seek help in the intervention group, but not in the control group (coef.=2.06, 95% CI 0.48 to 3.63, P=0.01). Conclusions Our trial demonstrates the potential for men’s health outcomes to be positively impacted by novel, media-based public health interventions that focus on traditional masculinity. Trial registration number ACTRN12616001169437, Results. PMID:29101215

Implementation of an educational intervention to improve hand washing in primary schools: process evaluation within a randomised controlled trial

PubMed Central

2013-01-01

Background Process evaluations are useful for understanding how interventions are implemented in trial settings. This is important for interpreting main trial results and indicating how the intervention might function beyond the trial. The purpose of this study was to examine the reach, dose, fidelity, acceptability, and sustainability of the implementation of an educational hand washing intervention in primary schools, and to explore views regarding acceptability and sustainability of the intervention. Methods Process evaluation within a cluster randomised controlled trial, including focus groups with pupils aged 6 to 11, semi-structured interviews with teachers and external staff who coordinated the intervention delivery, and school reports and direct observations of the intervention delivery. Results The educational package was delivered in 61.4% of schools (85.2% of intervention schools, 37.8% of control schools following completion of the trial). Teachers and pupils reacted positively to the intervention, although concerns were raised about the age-appropriateness of the resources. Teachers adapted the resources to suit their school setting and pupils. Staff coordinating the intervention delivery had limited capacity to follow up and respond to schools. Conclusions The hand washing intervention was acceptable to schools, but its reach outside of a randomised trial, evidenced in the low proportion of schools in the control arm who received it after the trial had ended, suggests that the model of delivery may not be sustainable. Trial registration ISRCTN: ISRCTN93576146 PMID:23947388

Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials.

PubMed

de Labra, Carmen; Guimaraes-Pinheiro, Christyanne; Maseda, Ana; Lorenzo, Trinidad; Millán-Calenti, José C

2015-12-02

Low physical activity has been shown to be one of the most common components of frailty, and interventions have been considered to prevent or reverse this syndrome. The purpose of this systematic review of randomized, controlled trials is to examine the exercise interventions to manage frailty in older people. The PubMed, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched using specific keywords and Medical Subject Headings for randomized, controlled trials published during the period of 2003-2015, which enrolled frail older adults in an exercise intervention program. Studies where frailty had been defined were included in the review. A narrative synthesis approach was performed to examine the results. The Physiotherapy Evidence Database (PEDro scale) was used to assess the methodological quality of the selected studies. Of 507 articles, nine papers met the inclusion criteria. Of these, six included multi-component exercise interventions (aerobic and resistance training not coexisting in the intervention), one included physical comprehensive training, and two included exercises based on strength training. All nine of these trials included a control group receiving no treatment, maintaining their habitual lifestyle or using a home-based low level exercise program. Five investigated the effects of exercise on falls, and among them, three found a positive impact of exercise interventions on this parameter. Six trials reported the effects of exercise training on several aspects of mobility, and among them, four showed enhancements in several measurements of this outcome. Three trials focused on the effects of exercise intervention on balance performance, and one demonstrated enhanced balance. Four trials investigated functional ability, and two showed positive results after the intervention. Seven trials investigated the effects of exercise intervention on muscle strength, and five of them reported increases; three trials investigated the effects of exercise training on body composition, finding improvements in this parameter in two of them; finally, one trial investigated the effects of exercise on frailty using Fried's criteria and found an improvement in this measurement. Exercise interventions have demonstrated improvement in different outcome measurements in frail older adults, however, there were large differences between studies with regard to effect sizes. This systematic review suggested that frail older adults seemed to benefit from exercise interventions, although the optimal program remains unclear. More studies of this topic and with frail populations are needed to select the most favorable exercise program.

Effect of dexmedetomidine on intraocular pressure in patients undergoing robot-assisted laparoscopic radical prostatectomy under total intravenous anesthesia: A randomized, double blinded placebo controlled clinical trial.

PubMed

Kitamura, Sakiko; Takechi, Kenichi; Nishihara, Tasuku; Konishi, Amane; Takasaki, Yasushi; Yorozuya, Toshihiro

2018-06-05

To study the effects of intraoperative dexmedetomidine on the intraocular pressure (IOP) in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP) under propofol-remifentanil anesthesia. Double-blind, randomized controlled trial. Operating room. Forty consenting male patients aged ≥20 to <80 years with American Society of Anesthesiologists physical status classes I and II. The patients were randomly assigned to either dexmedetomidine (DEX) (n = 20) or control (n = 20) group. Anesthesia was induced and maintained using propofol, remifentanil, and rocuronium. In the dexmedetomidine group, dexmedetomidine was administered at 0.4 μg/kg/h immediately after anesthesia induction until the end of the surgery, whereas normal saline was administered as placebo in the control group. IOP was measured using a rebound tonometer. Time points of measuring IOP were as follows: T1: before anesthesia induction, T2: 5 min after intubation, T3: 60 min after placing patient in the Trendelenburg position, T4: 120 min after placing patient in the Trendelenburg position, T5: 180 min after placing patient in the Trendelenburg position, T6: 5 min after placing patient in a horizontal position, T7: 5 min after extubation, and T8: 30 min after extubation. A linear mixed model analysis demonstrated a significant intergroup difference in IOP over time and during pneumoperitoneum in the steep Trendelenburg position. IOP at T5 was significantly lower in the dexmedetomidine group than in the control group even after post-hoc analysis in the steep Trendelenburg position periods with Bonferroni correction. Dexmedetomidine combined with propofol decreases IOP in the steep Trendelenburg position during RALRP. Copyright © 2018 Elsevier Inc. All rights reserved.

EOS-based cup navigation: Randomised controlled trial in 78 total hip arthroplasties.

PubMed

Verdier, N; Billaud, A; Masquefa, T; Pallaro, J; Fabre, T; Tournier, C

2016-06-01

Minimising the risk of cup implantation outside the safe zone is among the objectives of navigation during total hip arthroplasty (THA). However, given the technical challenges raised by navigation when the patient is lying on the side, many surgeons still use the freehand technique. We conducted a randomised controlled trial to evaluate the new navigation system NAVEOS in the iliac plane, which is easily identified in the lateral decubitus position, with the objective of determining whether NAVEOS navigation decreased the frequency of cup implantation outside the safe zone compared to freehand cup positioning, without increasing the operative time or the frequency of complications. NAVEOS navigation decreases the frequency of cup positioning outside the safe zone compared to freehand positioning. This randomised controlled trial compared cup positioning using NAVEOS navigation versus the freehand technique in patients undergoing primary THA. The safe zone was defined according to Lewinnek as 15±10° of radiological anteversion and 40±10° of radiological inclination. Cup position parameters were measured on computed tomography images obtained 3months after THA. The images were read by two independent observers who were blinded to group assignment. The primary evaluation criterion was cup position within the safe zone. A 1:1 randomisation scheme was used to assign 78 patients (mean age, 68years; age range, 44-91years) to NAVEOS navigation or freehand cup positioning. The two groups were comparable for age, gender distribution, body mass index, and preoperative functional scores. In the NAVEOS group, navigation was discontinued prematurely in 6 patients, because of technical difficulties (n=2) or a marked discrepancy with clinical findings (n=4); however, the intention-to-treat approach was used for the analysis. The proportion of cups in the safe zone was 67% (28/39) in the NAVEOS group and 38% (17/39) in the freehand group (P=0.012). Anteversion was within the 5-25° range for 72% (28/39) cups in the NAVEOS group and 46% (18/39) in the freehand group (P=0.021). Inclination was within the 30-50° range for 95% (37/39) of cups with NAVEOS navigation and 85% (33/39) with freehand positioning (P=0.135). The odds ratio for cup implantation outside the safe zone was significantly lower with NAVEOS compared to freehand positioning (0.54; 95% confidence interval, 0.31-0.91). Mean operative time was 74 (range, 45-115) minutes with NAVEOS navigation and 70 (range, 40-105) minutes with freehand positioning (P=0.382). Complications consisted of 1 case each of anterior dislocation and infection, both in the freehand group. Compared to freehand positioning, NAVEOS navigation significantly lowered the risk of cup positioning outside the safe zone, chiefly via improved achievement of the anteversion target. NAVEOS was not associated with increases in operative time or morbidity. II, randomised controlled trial with limited statistical power. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study.

PubMed

Hilton, Paul; Armstrong, Natalie; Brennand, Catherine; Howel, Denise; Shen, Jing; Bryant, Andrew; Tincello, Douglas G; Lucas, Malcolm G; Buckley, Brian S; Chapple, Christopher R; Homer, Tara; Vale, Luke; McColl, Elaine

2015-09-08

The position of invasive urodynamic testing (IUT) in diagnostic pathways for urinary incontinence is unclear, and systematic reviews have called for further trials evaluating clinical utility. The objective of this study was to inform the decision whether to proceed to a definitive randomised trial of IUT compared to clinical assessment with non-invasive tests, prior to surgery in women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). A mixed methods study comprising a pragmatic multicentre randomised pilot trial, a qualitative face-to face interview study with patients eligible for the trial, an exploratory economic evaluation including value of information study, a survey of clinicians' views about IUT, and qualitative telephone interviews with purposively sampled survey respondents. Only the first and second of these elements are reported here. Trial participants were randomised to either clinical assessment with non-invasive tests (control arm) or clinical assessment with non-invasive tests plus IUT (intervention arm). The main outcome measures of these feasibility studies were confirmation that units can identify and recruit eligible women, acceptability of investigation strategies and data collection tools, and acquisition of outcome data to determine the sample size for a definitive trial. The primary outcome proposed for a definitive trial was ICIQ-FLUTS (total score) 6 months after surgery or the start of nonsurgical treatment. Of 284 eligible women, 222 (78%) were recruited, 165/219 (75%) returned questionnaires at baseline, and 125/200 returned them (63%) at follow-up. Most women underwent surgery; management plans were changed in 19 (19%) participants following IUT. Participants interviewed were positive about the trial and the associated documentation. All elements of a definitive trial were rehearsed. Such a trial would require between 232 and 922 participants, depending on the target difference in the primary outcome. We identified possible modifications to our protocol for application in a definitive trial including clarity over inclusion/exclusions, screening processes, reduction in secondary outcomes, and modification to patient questionnaire booklets and bladder diaries. A definitive trial of IUT versus clinical assessment prior to surgery for SUI or stress predominant MUI is feasible and remains relevant. Current Controlled Trials: ISRCTN 71327395, registered 7 June 2010.

The Cognitive Effects of Antidepressants in Major Depressive Disorder: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

PubMed Central

Rosenblat, Joshua D; Kakar, Ron

2016-01-01

Background: Cognitive dysfunction is often present in major depressive disorder (MDD). Several clinical trials have noted a pro-cognitive effect of antidepressants in MDD. The objective of the current systematic review and meta-analysis was to assess the pooled efficacy of antidepressants on various domains of cognition in MDD. Methods: Trials published prior to April 15, 2015, were identified through searching the Cochrane Central Register of Controlled Trials, PubMed, Embase, PsychINFO, Clinicaltrials.gov, and relevant review articles. Data from randomized clinical trials assessing the cognitive effects of antidepressants were pooled to determine standard mean differences (SMD) using a random-effects model. Results: Nine placebo-controlled randomized trials (2 550 participants) evaluating the cognitive effects of vortioxetine (n = 728), duloxetine (n = 714), paroxetine (n = 23), citalopram (n = 84), phenelzine (n = 28), nortryptiline (n = 32), and sertraline (n = 49) were identified. Antidepressants had a positive effect on psychomotor speed (SMD 0.16; 95% confidence interval [CI] 0.05–0.27; I2 = 46%) and delayed recall (SMD 0.24; 95% CI 0.15–0.34; I2 = 0%). The effect on cognitive control and executive function did not reach statistical significance. Of note, after removal of vortioxetine from the analysis, statistical significance was lost for psychomotor speed. Eight head-to-head randomized trials comparing the effects of selective serotonin reuptake inhibitors (SSRIs; n = 371), selective serotonin and norepinephrine reuptake inhibitors (SNRIs; n = 25), tricyclic antidepressants (TCAs; n = 138), and norepinephrine and dopamine reuptake inhibitors (NDRIs; n = 46) were identified. No statistically significant difference in cognitive effects was found when pooling results from head-to-head trials of SSRIs, SNRIs, TCAs, and NDRIs. Significant limitations were the heterogeneity of results, limited number of studies, and small sample sizes. Conclusions: Available evidence suggests that antidepressants have a significant positive effect on psychomotor speed and delayed recall. PMID:26209859

Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results.

PubMed

Suñé, Pilar; Suñé, Josep Maria; Montoro, J Bruno

2013-01-01

Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved), negative (when no statistical significance was achieved or it favored control drug) and descriptive (for non-controlled studies). Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785). Study results were identified for 68·9% of all completed clinical trials (541/785). Publication rate was 84·9% (180/212) for studies with results classified as positive and 68·9% (128/186) for studies with results classified as negative (p<0·001). Median time to publication was 2·09 years (IC95 1·61-2·56) for studies with results classified as positive and 3·21 years (IC95 2·69-3·70) for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55-2·55). No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141-28·409) and negative result studies (median 8·266, interquartile range: 4·135-17·157). Clinical trials with positive outcomes have significantly higher rates and shorter times to publication than those with negative results. However, no differences have been found in terms of impact factor.

[Position paper on the results of Symplicity HTN-3 trial. Grupo de estudio de la hipertensión arterial resistente].

PubMed

Azpiri-López, José Ramón; Assad-Morell, José Luis; Ponce de León-Martínez, Enrique; Monreal-Puente, Rogelio; Dávila-Bortoni, Adrián; Vázquez-Díaz, Luis Alberto; Treviño-Frutos, Ramón Javier; Barrera-Oranday, Félix; Del Angel-Soto, Juan Gustavo; Martínez, José Guadalupe; Arellano-Torres, Marcelo

2015-01-01

Renal artery denervation has shown to be an effective treatment for resistant hypertension. Symplicity HTN 1 and 2 trials showed in small and uncontrolled groups, significant systolic blood pressure reductions down to 30 mm Hg. Symplicity HTN-3, a double blind, randomized, placebo controlled clinical trial shaded this initial enthusiasm. Surprisingly, their results showed that renal denervation has a similar effect to placebo. Pre-specified subgroup analysis showed that non-black race individuals, younger than 65 years and with normal renal function, had a statistically significant systolic blood pressure decrease. This manuscript critically appraises the Symplicity HTN-3 trial, proposing possible explanations for the results. Also declares our group position and future actions regarding renal denervation. Copyright © 2014 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

The effect of walking and vitamin B supplementation on quality of life in community-dwelling adults with mild cognitive impairment: a randomized, controlled trial

PubMed Central

van Uffelen, Jannique G. Z.; Hopman-Rock, Marijke; van Mechelen, Willem

2007-01-01

Objectives To examine the effect of walking and vitamin B supplementation on quality-of-life (QoL) in community-dwelling adults with mild cognitive impairment. Methods One year, double-blind, placebo-controlled trial. Participants were randomized to: (1) twice-weekly, group-based, moderate-intensity walking program (n = 77) or a light-intensity placebo activity program (n = 75); and (2) daily vitamin B pills containing 5 mg folic acid, 0.4 mg B12, 50 mg B6 (n = 78) or placebo pills (n = 74). QoL was measured at baseline, after six and 12 months using the population-specific Dementia Quality-of-Life (D-QoL) to assess overall QoL and the generic Short-Form 12 mental and physical component scales (SF12-MCS and SF12-PCS) to assess health-related QoL. Results Baseline levels of QoL were relatively high. Modified intention-to-treat analyses revealed no positive main intervention effect of walking or vitamin supplementation. In both men and women, ratings of D-QoL-belonging and D-QoL-positive affect subscales improved with 0.003 (P = 0.04) and 0.002 points (P = 0.06) with each percent increase in attendance to the walking program. Only in men, SF12-MCS increased with 0.03 points with each percent increase in attendance (P = 0.08). Conclusion Several small but significant improvements in QoL were observed with increasing attendance to the walking program. No effect of vitamin B supplementation was observed. Trial Registration International Standard Randomized Controlled Trial Number Register, 19227688, http://www.controlled-trials.com/isrctn/. PMID:17616840

Maternal note-taking and infant care: a pilot randomised controlled trial.

PubMed

Kistin, Caroline J; Barrero-Castillero, Alejandra; Lewis, Sheilajane; Hoch, Rachel; Philipp, Barbara L; Bauchner, Howard; Wang, C Jason

2012-10-01

A pilot randomised controlled trial was conducted with postpartum mothers to assess the feasibility and impact of note-taking during newborn teaching. Controls received standard teaching; the intervention group received pen and paper to take notes. Subjects were called 2 days post-discharge to assess infant sleep position, breastfeeding, car seat use, satisfaction and information recall. 126 mothers were randomised. There was a consistent trend that intervention subjects were more likely to report infant supine sleep position (88% vs 78%, relative risks (RR) 1.13; 95% CI 0.95 to 1.34), breastfeeding (96% vs 86%, RR 1.11; 95% CI 0.99 to 1.25) and correct car seat use (98% vs 87%, RR 1.12; 95% CI 1.00 to 1.25). Satisfaction and information recall did not differ. Among first-time mothers, intervention subjects were significantly more likely to report infant supine sleep position (95% vs 65%, RR 1.46; 95% CI 1.06 to 2.00). Maternal note-taking is feasible and potentially efficacious in promoting desirable infant care.

Impact of Playing Exergames on Mood States: A Randomized Controlled Trial.

PubMed

Huang, Han-Chung; Wong, May-Kuen; Yang, Ya-Hui; Chiu, Hsin-Ying; Teng, Ching-I

2017-04-01

To examine how playing exergames impacts the mood states of university students and staff, and whether such an impact depends on gender and players' previous exercise time. This study was designed as a randomized controlled trial. It enrolled 337 participants and randomly assigned them to an intervention group (n = 168) or a control group (n = 167). A 2-week exergame program was designed for the participants in the intervention group. They were required to play exergames for 30 consecutive minutes each week for 2 weeks and respond to the items measuring vigor, happiness, and perceived stress. All measures were administered before and after the study. Repeated measures analysis of variances were conducted. Playing exergames enhanced vigor and happiness for participants in the intervention group. This group exhibited more positive change in vigor and happiness than the control group. This effect of playing exergames was not moderated by gender, age, occupation (student or staff), or previous exercise time. Playing exergames may induce positive mood states among university students and staff.

Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand.

PubMed

Simmons, Nicole; Donnell, Deborah; Ou, San-San; Celentano, David D; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

2015-10-01

Controlled trials of HIV prevention and care interventions are susceptible to contamination. In a randomized controlled trial of a social network peer education intervention among people who inject drugs and their risk partners in Philadelphia, PA and Chiang Mai, Thailand, we tested a contamination measure based on recall of intervention terms. We assessed the recall of test, negative and positive control terms among intervention and control arm participants and compared the relative odds of recall of test versus negative control terms between study arms. The contamination measures showed good discriminant ability among participants in Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was strong evidence of diffusion and contamination. Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in experimental interventions.

Efficacy and safety of acarbose chewable tablet in patients with type 2 diabetes: a multicentre, randomized, double-blinded, double-dummy positive controlled trial.

PubMed

Wu, Qian Lin; Liu, Yu Ping; Lu, Ju Ming; Wang, Chang Jiang; Yang, Tao; Dong, Ji Xiang; Li, Cheng Jiang; Ma, Jian Hua; Xue, Yao Ming; Sun, Rui Hua; Wei, Dong; Tian, Hao Ming

2012-08-01

To evaluate the effect and safety of HbA1c and glycemic control of acarbose chewable tablets in patients with type 2 diabetic. A multicentre, randomized, double-blinded, double-dummy, positive controlled clinical trial was conducted. Two hundred thirty-four Chinese patients with type 2 diabetic were enrolled in eight clinical centres, who were divided randomly into the acarbose chewable tablet group (experimental group, n = 116) and the acarbose treatment group (control group, n = 118). Two hundred seven patients (88.5%) took part in the 12-week trial. At the beginning and end of the clinical trial, HbA1c and blood glucose as well as safety indexes were measured. After the treatment, the level of finger two-hour postprandial blood glucose (PPBG) was decreased 4.15 mmol/L (26.82%) and 3.54 mmol/L (22.77%), respectively, in the experiment group and the control group. The levels of venous two-hour PPBG in the experiment group and the control group were decreased 4.04 mmol/L (25.38%) and 2.75 mmol/L (17.26%), respectively, with the means of HbA1c lowering 11.67% and 12.44%, respectively. Fasting blood glucose (FBG) also was reduced significantly in both groups. Patients in both groups showed obvious weight reduction (P < 0.0001). There were no significant differences in the incidence of adverse events between the two groups. In summary, acarbose chewable tablets have a definite curative effect in treating type 2 diabetic patients as HbA1c and blood glucose levels decreased significantly after the 12-week treatment. © 2012 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Challenges and opportunities in SLE clinical trials.

PubMed

van Vollenhoven, Ronald F

2013-09-01

To provide an update on the field of clinical trials in systemic lupus erythematosus (SLE). This review will examine failed and successful clinical trials in SLE in order to draw lessons and determine the optimal ways forward. Over the past decade, many clinical trials in SLE met with limited success, but in the past 2 years several SLE clinical trials have been successful. The two large phase III randomized controlled trials (RCTs) of belimumab achieved their primary endpoints and resulted in food and drug administration and European medicines agency approval of the drug. Characteristics of these trials were, among other things, a very large number of patients (>800 each), compound clinical endpoints, and a flexible design with regards to concomitant medication use. Likewise, large randomized controlled trials with mycophenolate mofetil, although nominally unsuccessful, clearly demonstrated the clinical benefit of this drug in lupus nephritis. Posthoc analyses of several failed trials involving abatacept and rituximab revealed design elements and/or outcomes that might have changed the outcomes of these studies. Many smaller trials have also been reported, in some instances with surprisingly positive results. An improved understanding of specific design features in SLE clinical trials combined with robust outcomes will make it possible more effectively to design and conduct clinical trials in SLE.

Physical therapy with drug treatment in Bell palsy: a focused review.

PubMed

Ferreira, Margarida; Marques, Elisa E; Duarte, José A; Santos, Paula C

2015-04-01

The physical therapy (PT) associated with standard drug treatment (SDT) in Bell palsy has never been investigated. Randomized controlled trials or quasirandomized controlled trials have compared facial PT (except treatments such as acupuncture and osteopathic) combined with SDT against a control group with SDT alone. Participants included those older than 15 yrs with a clinical diagnosis of Bell palsy, and the primary outcome measure was motor function recovery by the House-Brackmann scale. The methodologic quality of each study was also independently assessed by two reviewers using the PEDro scale. Four studies met the inclusion criteria. Three trials indicate that PT in association with SDT supports higher motor function recovery than SDT alone between 15 days and 1 yr of follow-up. On the other hand, one trial showed that electrical stimulation added to conventional PT with SDT did not influence treatment outcomes. The present review suggests that the current practice of Bell palsy treatment by PT associated with SDT seems to have a positive effect on grade and time recovery compared with SDT alone. However, there is very little quality evidence from randomized controlled trials, and such evidence is insufficient to decide whether combined treatment is beneficial in the management of Bell palsy.

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

PubMed

Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

2017-01-17

 To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).  Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial.

PubMed

Bluth, T; Teichmann, R; Kiss, T; Bobek, I; Canet, J; Cinnella, G; De Baerdemaeker, L; Gregoretti, C; Hedenstierna, G; Hemmes, S N; Hiesmayr, M; Hollmann, M W; Jaber, S; Laffey, J G; Licker, M J; Markstaller, K; Matot, I; Müller, G; Mills, G H; Mulier, J P; Putensen, C; Rossaint, R; Schmitt, J; Senturk, M; Serpa Neto, A; Severgnini, P; Sprung, J; Vidal Melo, M F; Wrigge, H; Schultz, M J; Pelosi, P; Gama de Abreu, M

2017-04-28

Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m 2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH 2 O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH 2 O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs. ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.

Tuberculosis Control in South African Gold Mines: Mathematical Modeling of a Trial of Community-Wide Isoniazid Preventive Therapy

PubMed Central

Vynnycky, Emilia; Sumner, Tom; Fielding, Katherine L.; Lewis, James J.; Cox, Andrew P.; Hayes, Richard J.; Corbett, Elizabeth L.; Churchyard, Gavin J.; Grant, Alison D.; White, Richard G.

2015-01-01

A recent major cluster randomized trial of screening, active disease treatment, and mass isoniazid preventive therapy for 9 months during 2006–2011 among South African gold miners showed reduced individual-level tuberculosis incidence but no detectable population-level impact. We fitted a dynamic mathematical model to trial data and explored 1) factors contributing to the lack of population-level impact, 2) the best-achievable impact if all implementation characteristics were increased to the highest level achieved during the trial (“optimized intervention”), and 3) how tuberculosis might be better controlled with additional interventions (improving diagnostics, reducing treatment delay, providing isoniazid preventive therapy continuously to human immunodeficiency virus–positive people, or scaling up antiretroviral treatment coverage) individually and in combination. We found the following: 1) The model suggests that a small proportion of latent infections among human immunodeficiency virus–positive people were cured, which could have been a key factor explaining the lack of detectable population-level impact. 2) The optimized implementation increased impact by only 10%. 3) Implementing additional interventions individually and in combination led to up to 30% and 75% reductions, respectively, in tuberculosis incidence after 10 years. Tuberculosis control requires a combination prevention approach, including health systems strengthening to minimize treatment delay, improving diagnostics, increased antiretroviral treatment coverage, and effective preventive treatment regimens. PMID:25792607

Chinese herbal medicine for diabetic peripheral neuropathy.

PubMed

Chen, Wei; Zhang, Yin; Li, Xinxue; Yang, Guoyan; Liu, Jian Ping

2013-10-06

Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy.This is an update of a Cochrane review that was first published in the year 2011. To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy. On 14 May 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register CENTRAL (2012, Issue 4 in The Cochrane Library), MEDLINE (January 1966 to May 2012), EMBASE (January 1980 to May 2012), AMED (January 1985 to May 2012) and in October 2012, the Chinese Biomedical Database (CBM) (1979 to October 2012), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to October 2012), and VIP Chinese Science and Technique Journals Database (1989 to October 2012). We searched for unpublished literature in the Chinese Conference Papers Database, and Chinese Dissertation Database (from inception to October 2012). There were no language or publication restrictions. We included randomised controlled trials of Chinese herbal medicine (with a minimum of four weeks treatment duration) for people with diabetic peripheral neuropathy compared with placebo, no intervention, or conventional interventions. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information. Forty-nine randomised trials involving 3639 participants were included. All trials were conducted and published in China. Thirty-eight different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 26 self concocted Chinese herbal compound prescriptions. The trials reported on global symptom improvement (including improvement in numbness or pain) and changes in nerve conduction velocity. The positive results described from the 49 studies of low quality are of questionable significance. There was inadequate reporting on adverse events in the included trials. Eighteen trials found no adverse events. Two trials reported adverse events: adverse events occurred in the control group in one trial, and in the other it was unclear in which group the adverse events occurred. 29 trials did not mention whether they monitored adverse events. Conclusions cannot be drawn from this review about the safety of herbal medicines, due to inadequate reporting. Most of the trials were of very low methodological quality and therefore the interpretation of any positive findings for the efficacy of the included Chinese herbal medicines for treating diabetic peripheral neuropathy should be made with caution. Based on this systematic review, there is no evidence to support the objective effectiveness and safety of Chinese herbal medicines for diabetic peripheral neuropathy. No well-designed, randomised, placebo controlled trial with objective outcome measures has been conducted.

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.

Proactive Control: Neural Oscillatory Correlates of Conflict Anticipation and Response Slowing.

PubMed

Chang, Andrew; Ide, Jaime S; Li, Hsin-Hung; Chen, Chien-Chung; Li, Chiang-Shan R

2017-01-01

Proactive control allows us to anticipate environmental changes and adjust behavioral strategy. In the laboratory, investigators have used a number of different behavioral paradigms, including the stop-signal task (SST), to examine the neural processes of proactive control. Previous functional MRI studies of the SST have demonstrated regional responses to conflict anticipation-the likelihood of a stop signal or P(stop) as estimated by a Bayesian model-and reaction time (RT) slowing and how these responses are interrelated. Here, in an electrophysiological study, we investigated the time-frequency domain substrates of proactive control. The results showed that conflict anticipation as indexed by P(stop) was positively correlated with the power in low-theta band (3-5 Hz) in the fixation (trial onset)-locked interval, and go-RT was negatively correlated with the power in delta-theta band (2-8 Hz) in the go-locked interval. Stimulus prediction error was positively correlated with the power in the low-beta band (12-22 Hz) in the stop-locked interval. Further, the power of the P(stop) and go-RT clusters was negatively correlated, providing a mechanism relating conflict anticipation to RT slowing in the SST. Source reconstruction with beamformer localized these time-frequency activities close to brain regions as revealed by functional MRI in earlier work. These are the novel results to show oscillatory electrophysiological substrates in support of trial-by-trial behavioral adjustment for proactive control.

A pilot RCT of psychodynamic group art therapy for patients in acute psychotic episodes: feasibility, impact on symptoms and mentalising capacity.

PubMed

Montag, Christiane; Haase, Laura; Seidel, Dorothea; Bayerl, Martin; Gallinat, Jürgen; Herrmann, Uwe; Dannecker, Karin

2014-01-01

This pilot study aimed to evaluate the feasibility of an assessor-blind, randomised controlled trial of psychodynamic art therapy for the treatment of patients with schizophrenia, and to generate preliminary data on the efficacy of this intervention during acute psychotic episodes. Fifty-eight inpatients with DSM-diagnoses of schizophrenia were randomised to either 12 twice-weekly sessions of psychodynamic group art therapy plus treatment as usual or to standard treatment alone. Primary outcome criteria were positive and negative psychotic and depressive symptoms as well as global assessment of functioning. Secondary outcomes were mentalising function, estimated with the Reading the mind in the eyes test and the Levels of emotional awareness scale, self-efficacy, locus of control, quality of life and satisfaction with care. Assessments were made at baseline, at post-treatment and at 12 weeks' follow-up. At 12 weeks, 55% of patients randomised to art therapy, and 66% of patients receiving treatment as usual were examined. In the per-protocol sample, art therapy was associated with a significantly greater mean reduction of positive symptoms and improved psychosocial functioning at post-treatment and follow-up, and with a greater mean reduction of negative symptoms at follow-up compared to standard treatment. The significant reduction of positive symptoms at post-treatment was maintained in an attempted intention-to-treat analysis. There were no group differences regarding depressive symptoms. Of secondary outcome parameters, patients in the art therapy group showed a significant improvement in levels of emotional awareness, and particularly in their ability to reflect about others' emotional mental states. This is one of the first randomised controlled trials on psychodynamic group art therapy for patients with acute psychotic episodes receiving hospital treatment. Results prove the feasibility of trials on art therapy during acute psychotic episodes and justify further research to substantiate preliminary positive results regarding symptom reduction and the recovery of mentalising function. ClinicalTrials.gov NCT01622166.

The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25–28 weeks gestation

PubMed Central

2014-01-01

Background It is now recognized that preterm infants ≤28 weeks gestation can be effectively supported from the outset with nasal continuous positive airway pressure. However, this form of respiratory therapy may fail to adequately support those infants with significant surfactant deficiency, with the result that intubation and delayed surfactant therapy are then required. Infants following this path are known to have a higher risk of adverse outcomes, including death, bronchopulmonary dysplasia and other morbidities. In an effort to circumvent this problem, techniques of minimally-invasive surfactant therapy have been developed, in which exogenous surfactant is administered to a spontaneously breathing infant who can then remain on continuous positive airway pressure. A method of surfactant delivery using a semi-rigid surfactant instillation catheter briefly passed into the trachea (the “Hobart method”) has been shown to be feasible and potentially effective, and now requires evaluation in a randomised controlled trial. Methods/design This is a multicentre, randomised, masked, controlled trial in preterm infants 25–28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017. Discussion Minimally-invasive surfactant therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25–28 weeks gestation. Trial registration Australia and New Zealand Clinical Trial Registry: ACTRN12611000916943; ClinicalTrials.gov: NCT02140580. PMID:25164872

Can a documentary increase help-seeking intentions in men? A randomised controlled trial.

PubMed

King, Kylie Elizabeth; Schlichthorst, Marisa; Spittal, Matthew J; Phelps, Andrea; Pirkis, Jane

2018-01-01

We investigated whether a public health intervention-a three-part documentary called Man Up which explored the relationship between masculinity and mental health, well-being and suicidality-could increase men's intentions to seek help for personal and emotional problems. We recruited men aged 18 years or over who were not at risk of suicide to participate in a double-blind randomised controlled trial. Participants were randomly assigned (1:1) via computer randomisation to view Man Up (the intervention) or a control documentary. We hypothesised that 4 weeks after viewing Man Up participants would report higher levels of intention to seek help than those who viewed the control documentary. Our primary outcome was assessed using the General Help Seeking Questionnaire, and was analysed for all participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616001169437, Universal Trial Number: U1111-1186-1459) and was funded by the Movember Foundation. Three hundred and fifty-four men were assessed for eligibility for the trial and randomised to view Man Up or the control documentary. Of these, 337 completed all stages (nine participants were lost to follow-up in the intervention group and eight in the control group). Linear regression analysis showed a significant increase in intentions to seek help in the intervention group, but not in the control group (coef.=2.06, 95% CI 0.48 to 3.63, P=0.01). Our trial demonstrates the potential for men's health outcomes to be positively impacted by novel, media-based public health interventions that focus on traditional masculinity. ACTRN12616001169437, Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia--a multi-centre randomised controlled trial.

PubMed

Priebe, Stefan; Savill, Mark; Reininghaus, Ulrich; Wykes, Til; Bentall, Richard; Lauber, Christoph; McCrone, Paul; Röhricht, Frank; Eldridge, Sandra

2013-01-14

Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Current Controlled Trials ISRCTN84216587.

Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial

PubMed Central

Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

2016-01-01

Objective To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. Trial design A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust. Participants Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Intervention Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. Outcome measures 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. Outcome The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. Conclusions All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. Trial registration number ISRCTN80067039. PMID:28186943

Cephalic version by postural management for breech presentation.

PubMed

Hofmeyr, G Justus; Kulier, Regina

2012-10-17

Babies with breech presentation (bottom first) are at increased risk of complications during birth, and are often delivered by caesarean section. The chance of breech presentation persisting at the time of delivery, and the risk of caesarean section, can be reduced by external cephalic version (ECV - turning the baby by manual manipulation through the mother's abdomen). It is also possible that maternal posture may influence fetal position. Many postural techniques have been used to promote cephalic version. The objective of this review was to assess the effects of postural management of breech presentation on measures of pregnancy outcome. We evaluated procedures in which the mother rests with her pelvis elevated. These include the knee-chest position, and a supine position with the pelvis elevated with a wedge-shaped cushion. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (22 August 2012). Randomised and quasi-randomised trials comparing postural management with pelvic elevation for breech presentation, with a control group. One or both review authors assessed eligibility and trial quality. We have included six studies involving a total of 417 women. The rates for non-cephalic births, Cesarean section and Apgar scores below 7 at one minute, regardless of whether ECV was attempted or not, were similar between the intervention and control groups (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.84 to 1.15; RR 1.10; 95% CI 0.89 to 1.37; RR 0.88; 95% CI 0.50 to 1.55). There is insufficient evidence from well-controlled trials to support the use of postural management for breech presentation. The numbers of women studied to date remain relatively small. Further research is needed.

Computer-delivered indirect screening and brief intervention for drug use in the perinatal period: A randomized trial.

PubMed

Ondersma, Steven J; Svikis, Dace S; Thacker, Casey; Resnicow, Ken; Beatty, Jessica R; Janisse, James; Puder, Karoline

2018-04-01

Under-reporting of drug use in the perinatal period is well-documented, and significantly limits the reach of proactive intervention approaches. The Wayne Indirect Drug Use Screener (WIDUS) focuses on correlates of drug use rather than use itself. This trial tested a computer-delivered, brief intervention designed for use with indirect screen-positive cases, seeking to motivate reductions in drug use without presuming its presence. Randomized clinical trial with 500 WIDUS-positive postpartum women recruited between August 14, 2012 and November 19, 2014. Participants were randomly assigned to either a time control condition or a single-session, tailored, indirect brief intervention. The primary outcome was days of drug use over the 6-month follow-up period; secondary outcomes included urine and hair analyses results at 3- and 6-month follow-up. All outcomes were measured by blinded evaluators. Of the 500 participants (252 intervention and 248 control), 36.1% of participants acknowledged drug use in the 3 months prior to pregnancy, but 89% tested positive at the 6-month follow-up. Participants rated the intervention as easy to use (4.9/5) and helpful (4.4/5). Analyses revealed no between-group differences in drug use (52% in the intervention group, vs. 53% among controls; OR 1.03). Exploratory analyses also showed that intervention effects were not moderated by baseline severity, WIDUS score, or readiness to change. The present trial showed no evidence of efficacy for an indirect, single-session, computer-delivered, brief intervention designed as a complement to indirect screening. More direct approaches that still do not presume active drug use may be possible and appropriate. Copyright © 2018 Elsevier B.V. All rights reserved.

Adjunctive memantine in clozapine-treated refractory schizophrenia: an open-label 1-year extension study.

PubMed

Veerman, S R T; Schulte, P F J; Deijen, J B; de Haan, L

2017-01-01

In a recent placebo-controlled, double-blind crossover trial (n = 52), significant beneficial effects on memory (d = 0.30) and negative symptoms (d = 0.29) were found after 12 weeks of memantine augmentation in patients with clozapine-refractory schizophrenia. In this open-label 1-year extension study we report the long-term effects and tolerability of memantine add-on therapy to clozapine. Completers of the first trial who experienced beneficial effects during 12 weeks of memantine treatment received memantine for 1 year. Primary endpoints were memory and executive function using the Cambridge Neuropsychological Test Automated Battery, the Positive and Negative Syndrome Scale (PANSS), and the Clinical Global Impression Severity Scale (CGI-S). Of 31 randomized controlled trial completers who experienced beneficial effects from memantine, 24 received memantine for 1 year. The small improvement in memory found in the memantine condition in the placebo-controlled trial remained stable in the extension study. Executive function did not improve. After 26 weeks of memantine add-on therapy to clozapine, PANSS negative symptoms (r = 0.53), PANSS positive symptoms (r = 0.50) and PANSS total symptoms (r = 0.54) significantly improved. Even further significant improvement in all these measures was observed between 26 weeks and 52 weeks of memantine, with effect sizes varying from 0.39 to 0.51. CGI-S showed a non-significant moderate improvement at 26 weeks (r = 0.36) and 52 weeks (r = 0.34). Memantine was well tolerated without serious adverse effects. In the 1-year extension phase the favourable effect of adjunctive memantine on memory was sustained and we observed further improvement of negative, positive and overall symptoms in patients with clozapine-treated refractory schizophrenia.

Early mobilization of patients who have had a hip or knee joint replacement reduces length of stay in hospital: a systematic review.

PubMed

Guerra, Mark L; Singh, Parminder J; Taylor, Nicholas F

2015-09-01

To systematically review the effect of early mobilization after hip or knee joint replacement surgery on length of stay in an acute hospital. Randomized controlled trials were selected from electronic databases based on inclusion criterion requiring an experimental group mobilizing (sitting out of bed/walking) earlier than a comparison group post joint replacement surgery of the hip or knee in an acute hospital. Clinically homogeneous data were analyzed with meta-analysis. Five randomized controlled trials (totaling 622 participants) were included for review. A meta-analysis of 5 trials found a reduced length of stay of 1.8 days (95% confidence interval 1.1 to 2.6) in favor of the experimental group. In 4 of the 5 trials the experimental group first sat out of bed within 24 hours post operatively. In 4 of the 5 trials the experimental group first walked within 48 hours post operatively. Individual trials reported benefits in range of motion, muscle strength and health-related quality of life in favor of the experimental group. There were no differences in discharge destinations, incidence of negative outcomes or adverse events attributable to early mobilization when compared to the comparison groups. Early mobilization post hip or knee joint replacement surgery can result in a reduced length of stay of about 1.8 days. Trials that reported these positive results showed that early mobilization can be achieved within 24 hours of operation. This positive gain was achieved without an increase in negative outcomes. © The Author(s) 2014.

Can exergaming contribute to improving physical activity levels and health outcomes in children?

PubMed

Daley, Amanda J

2009-08-01

Physical inactivity among children is a serious public health problem. It has been suggested that high levels of screen time are contributory factors that encourage sedentary lifestyles in young people. As physical inactivity and obesity levels continue to rise in young people, it has been proposed that new-generation active computer- and video-console games (otherwise known as "exergaming") may offer the opportunity to contribute to young people's energy expenditure during their free time. Although studies have produced some encouraging results regarding the energy costs involved in playing active video-console games, the energy costs of playing the authentic versions of activity-based video games are substantially larger, highlighting that active gaming is no substitute for real sports and activities. A small number of exergaming activities engage children in moderate-intensity activity, but most do not. Only 3 very small trials have considered the effects of exergaming on physical activity levels and/or other health outcomes in children. Evidence from these trials has been mixed; positive trends for improvements in some health outcomes in the intervention groups were noted in 2 trials. No adequately powered randomized, controlled trial has been published to date, and no trial has assessed the long-term impact of exergaming on children's health. We now need high-quality randomized, controlled trials to evaluate the effectiveness and sustainability of exergaming, as well as its clinical relevance; until such studies take place, we should remain cautious about its ability to positively affect children's health.

Religion as a Basis for Dialogue in Peace Education Programs

ERIC Educational Resources Information Center

Yablon, Yaacov Boaz

2010-01-01

Religion could play a positive role in intergroup relations. However, this potential is usually overlooked and religion is often perceived as divisive and polarizing, perhaps even a source of intergroup conflict. This study examined religion as a possible tool for achieving positive intergroup encounters. A randomized control trial research design…

Impulse control and restrained eating among young women: Evidence for compensatory cortical activation during a chocolate-specific delayed discounting task.

PubMed

Dong, Debo; Wang, Yulin; Jackson, Todd; Chen, Shuaiyu; Wang, Yu; Zhou, Feng; Chen, Hong

2016-10-01

Theory and associated research indicate that people with elevated restrained eating (RE) scores have higher risk for binge eating, future bulimic symptom onset and weight gain. Previous imaging studies have suggested hyper-responsive reward brain area activation in response to food cues contributes to this risk but little is known about associated neural impulse control mechanisms, especially when considering links between depleted cognitive resources related to unsuccessful RE. Towards illuminating this issue, we used a chocolate-specific delayed discounting (DD) task to investigate relations between RE scores, behavior impulsivity, and corresponding neural impulse control correlates in a functional magnetic resonance imaging (fMRI) study of 27 young women. Specifically, participants were required to choose between more immediate, smaller versus delayed, larger hypothetical chocolate rewards following initial consumption of a chocolate. As predicted, RE scores were correlated positively with behavior impulse control levels. More critically, higher RE scores were associated with stronger activation in impulse control region, the dorsal-lateral prefrontal cortex (DLPFC) during the completion of difficult decision trials reflecting higher cognitive demands and resource depletion relative to easy decision trials. Exploratory analyses revealed a positive correlation between RE scores and activity in a reward system hub, the right striatum. Moreover, a positive correlation between left DLPFC and striatum activation was posited to reflect, in part, impulse control region compensation in response to stronger reward signal among women with RE elevations. Findings suggested impulse control lapses may contribute to difficulties in maintaining RE, particularly when cognitive demands are high. Copyright © 2016. Published by Elsevier Ltd.

Decision aids for randomised controlled trials: a qualitative exploration of stakeholders’ views

PubMed Central

Gillies, Katie; Skea, Zoë C; Campbell, Marion K

2014-01-01

Objectives To explore stakeholders’ perceptions of decision aids designed to support the informed consent decision-making process for randomised controlled trials. Design Qualitative semistructured interviews. Participants were provided with prototype trial decision aids in advance to stimulate discussion. Interviews were analysed using an established interpretive approach. Participants 23 stakeholders: Trial Managers (n=5); Research Nurses (n=5); Ethics Committee Chairs (n=5); patients (n=4) and Clinical Principal Investigators (n=4). Setting Embedded within two ongoing randomised controlled trials. All interviews conducted with UK-based participants. Results Certain key aspects (eg, values clarification exercises, presentation of probabilities, experiences of others and balance of options) in the prototype decision aids were perceived by all stakeholders as having a significant advantage (over existing patient information leaflets) in terms of supporting well informed appropriate decisions. However, there were some important differences between the stakeholder groups on specific content (eg, language used in the section on positive and negative features of taking part in a trial and the overall length of the trial decision aids). Generally the stakeholders believed trial decision aids have the potential to better engage potential participants in the decision-making process and allow them to make more personally relevant decisions about their participation. Conclusions Compared to existing patient information leaflets, stakeholders perceived decision aids for trial participation to have the potential to promote a more ‘informed’ decision-making process. Further efforts to develop, refine and formally evaluate trial decision aids should be explored. PMID:25138811

The efficacy of VIPP-V parenting training for parents of young children with a visual or visual-and-intellectual disability: a randomized controlled trial.

PubMed

Platje, Evelien; Sterkenburg, Paula; Overbeek, Mathile; Kef, Sabina; Schuengel, Carlo

2018-01-23

Video-feedback Intervention to promote positive parenting-visual (VIPP-V) or visual-and-intellectual disability is an attachment-based intervention aimed at enhancing sensitive parenting and promoting positive parent-child relationships. A randomized controlled trial was conducted to assess the efficacy of VIPP-V for parents of children aged 1-5 with visual or visual-and-intellectual disabilities. A total of 37 dyads received only care-as-usual (CAU) and 40 received VIPP-V besides CAU. The parents receiving VIPP-V did not show increased parental sensitivity or parent-child interaction quality, however, their parenting self-efficacy increased. Moreover, the increase in parental self-efficacy predicted the increase in parent-child interaction. In conclusion, VIPP-V does not appear to directly improve the quality of contact between parent and child, but does contribute to the self-efficacy of parents to support and to comfort their child. Moreover, as parents experience their parenting as more positive, this may eventually lead to higher sensitive responsiveness and more positive parent-child interactions.

Preoperative education interventions to reduce anxiety and improve recovery among cardiac surgery patients: a review of randomised controlled trials.

PubMed

Guo, Ping

2015-01-01

To update evidence of the effectiveness of preoperative education among cardiac surgery patients. Patients awaiting cardiac surgery may experience high levels of anxiety and depression, which can adversely affect their existing disease and surgery and result in prolonged recovery. There is evidence that preoperative education interventions can lead to improved patient experiences and positive postoperative outcomes among a mix of general surgical patients. However, a previous review suggested limited evidence to support the positive impact of preoperative education on patients' recovery from cardiac surgery. Comprehensive review of the literature. The Cochrane Central Register of Controlled Trials from the Cochrane Library, MEDLINE, CINAHL, PsycINFO, EMBASE and Web of Science were searched for English-language articles published between 2000-2011. Original articles were included reporting randomised controlled trials of cardiac preoperative education interventions. Six trials were identified and have produced conflicting findings. Some trials have demonstrated the effects of preoperative education on improving physical and psychosocial recovery of cardiac patients, while others found no evidence that patients' anxiety is reduced or of any effect on pain or hospital stay. Evidence of the effectiveness of preoperative education interventions among cardiac surgery patients remains inconclusive. Further research is needed to evaluate cardiac preoperative education interventions for sustained effect and in non-Western countries. A nurse-coordinated multidisciplinary preoperative education approach may offer a way forward to provide a more effective and efficient service. Staff training in developing and delivering such interventions is a priority. © 2014 John Wiley & Sons Ltd.

Benchmarking Controlled Trial—a novel concept covering all observational effectiveness studies

PubMed Central

Malmivaara, Antti

2015-01-01

Abstract The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals. PMID:25965700

Adaptive Randomization of Neratinib in Early Breast Cancer.

PubMed

Park, John W; Liu, Minetta C; Yee, Douglas; Yau, Christina; van 't Veer, Laura J; Symmans, W Fraser; Paoloni, Melissa; Perlmutter, Jane; Hylton, Nola M; Hogarth, Michael; DeMichele, Angela; Buxton, Meredith B; Chien, A Jo; Wallace, Anne M; Boughey, Judy C; Haddad, Tufia C; Chui, Stephen Y; Kemmer, Kathleen A; Kaplan, Henry G; Isaacs, Claudine; Nanda, Rita; Tripathy, Debasish; Albain, Kathy S; Edmiston, Kirsten K; Elias, Anthony D; Northfelt, Donald W; Pusztai, Lajos; Moulder, Stacy L; Lang, Julie E; Viscusi, Rebecca K; Euhus, David M; Haley, Barbara B; Khan, Qamar J; Wood, William C; Melisko, Michelle; Schwab, Richard; Helsten, Teresa; Lyandres, Julia; Davis, Sarah E; Hirst, Gillian L; Sanil, Ashish; Esserman, Laura J; Berry, Donald A

2016-07-07

The heterogeneity of breast cancer makes identifying effective therapies challenging. The I-SPY 2 trial, a multicenter, adaptive phase 2 trial of neoadjuvant therapy for high-risk clinical stage II or III breast cancer, evaluated multiple new agents added to standard chemotherapy to assess the effects on rates of pathological complete response (i.e., absence of residual cancer in the breast or lymph nodes at the time of surgery). We used adaptive randomization to compare standard neoadjuvant chemotherapy plus the tyrosine kinase inhibitor neratinib with control. Eligible women were categorized according to eight biomarker subtypes on the basis of human epidermal growth factor receptor 2 (HER2) status, hormone-receptor status, and risk according to a 70-gene profile. Neratinib was evaluated against control with regard to 10 biomarker signatures (prospectively defined combinations of subtypes). The primary end point was pathological complete response. Volume changes on serial magnetic resonance imaging were used to assess the likelihood of such a response in each patient. Adaptive assignment to experimental groups within each disease subtype was based on Bayesian probabilities of the superiority of the treatment over control. Enrollment in the experimental group was stopped when the 85% Bayesian predictive probability of success in a confirmatory phase 3 trial of neoadjuvant therapy reached a prespecified threshold for any biomarker signature ("graduation"). Enrollment was stopped for futility if the probability fell to below 10% for every biomarker signature. Neratinib reached the prespecified efficacy threshold with regard to the HER2-positive, hormone-receptor-negative signature. Among patients with HER2-positive, hormone-receptor-negative cancer, the mean estimated rate of pathological complete response was 56% (95% Bayesian probability interval [PI], 37 to 73%) among 115 patients in the neratinib group, as compared with 33% among 78 controls (95% PI, 11 to 54%). The final predictive probability of success in phase 3 testing was 79%. Neratinib added to standard therapy was highly likely to result in higher rates of pathological complete response than standard chemotherapy with trastuzumab among patients with HER2-positive, hormone-receptor-negative breast cancer. (Funded by QuantumLeap Healthcare Collaborative and others; I-SPY 2 TRIAL ClinicalTrials.gov number, NCT01042379.).

Deep breathing exercises with positive expiratory pressure in patients with multiple sclerosis - a randomized controlled trial.

PubMed

Westerdahl, Elisabeth; Wittrin, Anna; Kånåhols, Margareta; Gunnarsson, Martin; Nilsagård, Ylva

2016-11-01

Breathing exercises with positive expiratory pressure are often recommended to patients with advanced neurological deficits, but the potential benefit in multiple sclerosis (MS) patients with mild and moderate symptoms has not yet been investigated in randomized controlled trials. To study the effects of 2 months of home-based breathing exercises for patients with mild to moderate MS on respiratory muscle strength, lung function, and subjective breathing and health status outcomes. Forty-eight patients with MS according to the revised McDonald criteria were enrolled in a randomized controlled trial. Patients performing breathing exercises (n = 23) were compared with a control group (n = 25) performing no breathing exercises. The breathing exercises were performed with a positive expiratory pressure device (10-15 cmH 2 O) and consisted of 30 slow deep breaths performed twice a day for 2 months. Respiratory muscle strength (maximal inspiratory and expiratory pressure at the mouth), spirometry, oxygenation, thoracic excursion, subjective perceptions of breathing and self-reported health status were evaluated before and after the intervention period. Following the intervention, there was a significant difference between the breathing group and the control group regarding the relative change in lung function, favoring the breathing group (vital capacity: P < 0.043; forced vital capacity: P < 0.025). There were no other significant differences between the groups. Breathing exercises may be beneficial in patients with mild to moderate stages of MS. However, the clinical significance needs to be clarified, and it remains to be seen whether a sustainable effect in delaying the development of respiratory dysfunction in MS can be obtained. © 2015 The Authors. The Clinical Respiratory Journal published by John Wiley & Sons Ltd.

Efficacy of Platelet-Rich Fibrin After Mandibular Third Molar Extraction: A Systematic Review and Meta-Analysis.

PubMed

Al-Hamed, Faez Saleh; Tawfik, Mohamed Abdel-Monem; Abdelfadil, Ehab; Al-Saleh, Mohammed A Q

2017-06-01

To assess the effect of platelet-rich fibrin (PRF) on the healing process of the alveolar socket after surgical extraction of the mandibular third molars. PubMed, the Cochrane Central Register of Controlled Trials, Scopus, and relevant journals were searched using a combination of specific keywords ("platelet-rich fibrin," "oral surgery," and "third molar"). The final search was conducted on November 2, 2015. Randomized controlled clinical trials, as well as controlled clinical trials, aimed at comparing the effect of PRF versus natural healing after extraction of mandibular third molars were included. Five randomized controlled trials and one controlled clinical trial were included. There were 335 extractions (168 with PRF and 167 controls) in 183 participants. Considerable heterogeneity in study characteristics, outcome variables, and estimated scales was observed. Positive results were generally recorded for pain, trismus, swelling, periodontal pocket depth, soft tissue healing, and incidence of localized osteitis, but not in all studies. However, no meta-analysis could be conducted for such variables because of the different measurement scales used. The qualitative and meta-analysis results showed no significant improvement in bone healing with PRF-treated sockets compared with the naturally healing sockets. Within the limitations of the available evidence, PRF seems to have no beneficial role in bone healing after extraction of the mandibular third molars. Future standardized randomized controlled clinical trials are required to estimate the effect of PRF on socket regeneration. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial.

PubMed

Muñoz-Venturelli, Paula; Arima, Hisatomi; Lavados, Pablo; Brunser, Alejandro; Peng, Bin; Cui, Liying; Song, Lily; Billot, Laurent; Boaden, Elizabeth; Hackett, Maree L; Heritier, Stephane; Jan, Stephen; Middleton, Sandy; Olavarría, Verónica V; Lim, Joyce Y; Lindley, Richard I; Heeley, Emma; Robinson, Thompson; Pontes-Neto, Octavio; Natsagdorj, Lkhamtsoo; Lin, Ruey-Tay; Watkins, Caroline; Anderson, Craig S

2015-06-05

Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥ 30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke. We plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (≥ 30°) head position as a 'business as usual' stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (α 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period. HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke. ClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.

A Novel Nasal Expiratory Positive Airway Pressure (EPAP) Device for the Treatment of Obstructive Sleep Apnea: A Randomized Controlled Trial

PubMed Central

Berry, Richard B.; Kryger, Meir H.; Massie, Clifford A.

2011-01-01

Study Objectives: Investigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). Design: A prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial. Setting: 19 sites including both academic and private sleep disorder centers Patients: Obstructive sleep apnea with a pre-study AHI ≥ 10/hour Interventions: Treatment with a nasal EPAP device (N = 127) or similar appearing sham device (N = 123) for 3 months. Polysomnography (PSG) was performed on 2 non-consecutive nights (random order: device-on, device-off) at week 1 and after 3 months of treatment. Analysis of an intention to treat group (ITT) (patients completing week 1 PSGs) (EPAP N = 119, sham N = 110) was performed. Measurements and Results: At week 1, the median AHI value (device-on versus device-off) was significantly lower with EPAP (5.0 versus 13.8 events/h, P < 0.0001) but not sham (11.6 versus 11.1 events/h, P = NS); the decrease in the AHI (median) was greater (−52.7% vs. −7.3%, P < 0.0001) for the ITT group. At month 3, the percentage decrease in the AHI was 42.7% (EPAP) and 10.1% (sham), P < 0.0001. Over 3 months of EPAP treatment the Epworth Sleepiness Scale decreased (9.9 ± 4.7 to 7.2 ± 4.2, P < 0.0001), and the median percentage of reported nights used (entire night) was 88.2%. Conclusions: The nasal EPAP device significantly reduced the AHI and improved subjective daytime sleepiness compared to the sham treatment in patients with mild to severe OSA with excellent adherence. Clinical Trial Information: Registrations: ClinicalTrials.gov. Trial name: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO). URL: http://www.clinicaltrials.gov/ct2/show/NCT00772044?term=Ventus&rank=1. Registration Number: NCT00772044. Citation: Berry RB; Kryger MH; Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. SLEEP 2011;34(4):479-485. PMID:21461326

Position control of an industrial robot using fractional order controller

NASA Astrophysics Data System (ADS)

Clitan, Iulia; Muresan, Vlad; Abrudean, Mihail; Clitan, Andrei; Miron, Radu

2017-02-01

This paper presents the design of a control structure that ensures no overshoot for the movement of an industrial robot, used for the evacuation of round steel blocks from inside a rotary hearth furnace. First, a mathematical model for the positioning system is derived from a set of experimental data, and further, the paper focuses on obtaining a PID type controller, using the relay method as tuning method in order to obtain a stable closed loop system. The controller parameters are further tuned in order to achieve the imposed set of performances for the positioning of the industrial robot through computer simulation, using trial and error method. Further, a fractional - order PID controller is obtained in order to improve the control signal variation, so as to fit within the range of unified current's variation, 4 to 20 mA.

Delayed temporal discrimination in pigeons: A comparison of two procedures

PubMed Central

Chatlosh, Diane L.; Wasserman, Edward A.

1987-01-01

A within-subjects comparison was made of pigeons' performance on two temporal discrimination procedures that were signaled by differently colored keylight samples. During stimulus trials, a peck on the key displaying a slanted line was reinforced following short keylight samples, and a peck on the key displaying a horizontal line was reinforced following long keylight samples, regardless of the location of the stimuli on those two choice keys. During position trials, a peck on the left key was reinforced following short keylight samples and a peck on the right key was reinforced following long keylight samples, regardless of which line stimulus appeared on the correct key. Thus, on stimulus trials, the correct choice key could not be discriminated prior to the presentation of the test stimuli, whereas on position trials, the correct choice key could be discriminated during the presentation of the sample stimulus. During Phase 1, with a 0-s delay between sample and choice stimuli, discrimination learning was faster on position trials than on stimulus trials for all 4 birds. During Phase 2, 0-, 0.5-, and 1.0-s delays produced differential loss of stimulus control under the two tasks for 2 birds. Response patterns during the delay intervals provided some evidence for differential mediation of the two delayed discriminations. These between-task differences suggest that the same processes may not mediate performance in each. PMID:16812483

A systematic review of the effects of acupuncture on xerostomia and hyposalivation.

PubMed

Assy, Zainab; Brand, Henk S

2018-02-13

Saliva is fundamental to our oral health and our well-being. Many factors can impair saliva secretion, such as adverse effects of prescribed medication, auto-immune diseases (for example Sjögren's syndrome) and radiotherapy for head and neck cancers. Several studies have suggested a positive effect of acupuncture on oral dryness. Pubmed and Web of Science were electronically searched. Reference lists of the included studies and relevant reviews were manually searched. Studies that met the inclusion criteria were systematically evaluated. Two reviewers assessed each of the included studies to confirm eligibility and assessing the risk of bias. Ten randomized controlled trials investigating the effect of acupuncture were included. Five trials compared acupuncture to sham/placebo acupuncture. Four trials compared acupuncture to oral hygiene/usual care. Only one clinical trial used oral care sessions as control group. For all the included studies, the quality for all the main outcomes has been assessed as low. Although some publications suggest a positive effect of acupuncture on either salivary flow rate or subjective dry mouth feeling, the studies are inconclusive about the potential effects of acupuncture. Insufficient evidence is available to conclude whether acupuncture is an evidence-based treatment option for xerostomia/hyposalivation. Further well-designed, larger, double blinded trials are required to determine the potential benefit of acupuncture. Sample size calculations should be performed before before initiating these studies.

Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis.

PubMed

Khan, Nasim A; Lombeida, Juan I; Singh, Manisha; Spencer, Horace J; Torralba, Karina D

2012-07-01

To assess the association of industry funding with the characteristics, outcome, and reported quality of randomized controlled trials (RCTs) of drug therapy for rheumatoid arthritis (RA). The Medline and Cochrane Central Register of Controlled Trials databases were searched to identify original RA drug therapy RCTs published in 2002-2003 and 2006-2007. Two reviewers independently assessed each RCT for the funding source, characteristics, outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or not positive), and reporting of methodologic measures whose inadequate performance may have biased the assessment of treatment effect. RCTs that were registered at ClinicalTrials.gov and completed during the study years were assessed for publication bias. Of the 103 eligible RCTs identified, 58 (56.3%) were funded by industry, 19 (18.4%) were funded by nonprofit sources, 6 (5.8%) had mixed funding, and funding for 20 (19.4%) was not specified. Industry-funded RCTs had significantly more study centers and subjects, while nonprofit agency-funded RCTs had longer duration and were more likely to study different treatment strategies. Outcome could be assessed for 86 (83.5%) of the 103 RCTs studied. The funding source was not associated with a higher likelihood of positive outcomes favoring the sponsored experimental drug (75.5% of industry-funded RCTs had a positive outcome, compared with 68.8% of non-industry-funded RCTs, 40% of RCTs with mixed funding, and 81.2% of RCTs for which funding was not specified). Industry-funded RCTs showed a trend toward a higher likelihood of nonpublication (P=0.093). Industry-funded RCTs were more frequently associated with double-blinding, an adequate description of participant flow, and performance of an intent-to-treat analysis. Industry funding was not associated with a higher likelihood of positive outcomes of published RCTs of drug therapy for RA, and industry-funded RCTs performed significantly better than non-industry-funded RCTs in terms of reporting the use of some key methodologic quality measures. Copyright © 2012 by the American College of Rheumatology.

Positive Results Bias and Impact Factor in Ophthalmology.

PubMed

Mimouni, Michael; Krauthammer, Mark; Gershoni, Assaf; Mimouni, Francis; Nesher, Ronit

2015-01-01

Previous studies in several fields of medicine have reported an association between the result of a trial (positive versus negative) and the impact factor of the journal in which it is published. The purpose of this study was to test the hypotheses that in the field of ophthalmology: (1) studies with positive results have a greater chance of being published in journals with a higher impact factor; (2) likewise, studies with a larger number of participants are more likely to be published in journals with a higher impact factor. In this retrospective study, consecutive randomized, controlled trials conducted in the field of ophthalmology between 1 January 2010 and 1 January 2013 were retrieved from PubMed. Each study was classified as having either a positive or negative result. A positive result was defined as a study in which there was a statistically significant difference between groups (p < 0.05). The impact factor of the journal in which the study was published was retrieved. The number of patients enrolled and whether or not the trial was placebo controlled was documented as well. Out of 2524 studies identified, 892 met the inclusion criteria. Studies with positive results were published in journals with a significantly higher impact factor than that of the journals in which negative result studies were published (p < 0.001). Studies with positive results had a slightly larger number of participants than studies with negative results (p = 0.028). In multiple regression analysis, the ranked impact factor was significantly predicted by the primary outcome (positive versus negative results) and the number of participants in a study (total R(2 )= 2.95, p < 0.001). In the field of ophthalmology, articles with positive results are currently published in journals with a higher impact factor. This finding supports the ongoing occurrence of positive results bias in the field of ophthalmology.

Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial.

PubMed

Schotanus-Dijkstra, Marijke; Drossaert, Constance Hc; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

2015-08-20

Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. The Netherlands Trial Register NTR4297; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4297 (Archived by WebCite at http://webcitation.org/6Uwb5SUUM).

Study participant reported outcomes of mental health interventions: results from a randomized controlled trial among survivors of systematic violence in southern Iraq.

PubMed

Mahmooth, Z; Weiss, W M; Zangana, G A S; Bolton, P

2018-01-01

Common mental health problems experienced by survivors of systematic violence include trauma, depression, and anxiety. A trial of mental health interventions by community mental health workers for survivors of systematic violence in southern Iraq showed benefits from two psychotherapies on trauma, depression, anxiety, and function: Common Elements Treatment Approach (CETA) and cognitive processing therapy (CPT). This study assessed whether other non-predetermined changes reported by intervention participants were more common than in the control group. The trial involved 342 participants (CETA: 99 intervention, 50 control; CPT: 129 intervention, 64 control). Sixteen intervention-related changes since enrollment were identified from free-listing interviews of 15 early therapy completers. The changes were then added as a new quantitative module to the follow-up questionnaire. The changes were organized into eight groupings by thematic analysis - family, social standing, anger management, interest in regular activities, optimism, feeling close to God, avoiding smoking and drugs, and physical health. All participants were interviewed with this module and responses were compared between intervention and control participants. Multi-level, multi-variate regression models showed CETA intervention subjects with significant, positive changes relative to CETA controls on most themes. CPT intervention subjects showed little to no change compared with CPT controls in most themes. Participants receiving CETA reported more positive changes from therapy compared with controls than did participants receiving CPT. This study suggests differential effects of psychotherapy beyond the predetermined clinical outcome measures and that identification of these effects should be part of intervention evaluations.

Community involvement in dengue vector control: cluster randomised trial.

PubMed

Vanlerberghe, V; Toledo, M E; Rodríguez, M; Gomez, D; Baly, A; Benitez, J R; Van der Stuyft, P

2009-06-09

To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Cluster randomised trial. Guantanamo, Cuba. 32 circumscriptions (around 2000 inhabitants each). The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selective adulticiding, and health education) and to intervention clusters (n=16) comprising the routine Aedes control programme combined with a community based environmental management approach. The primary outcome was levels of Aedes infestation: house index (number of houses positive for at least one container with immature stages of Ae aegypti per 100 inspected houses), Breteau index (number of containers positive for immature stages of Ae aegypti per 100 inspected houses), and the pupae per inhabitant statistic (number of Ae aegypti pupae per inhabitant). All clusters were subjected to the intended intervention; all completed the study protocol up to February 2006 and all were included in the analysis. At baseline the Aedes infestation levels were comparable between intervention and control clusters: house index 0.25% v 0.20%, pupae per inhabitant 0.44x10(-3) v 0.29x10(-3). At the end of the intervention these indices were significantly lower in the intervention clusters: rate ratio for house indices 0.49 (95% confidence interval 0.27 to 0.88) and rate ratio for pupae per inhabitant 0.27 (0.09 to 0.76). A community based environmental management embedded in a routine control programme was effective at reducing levels of Aedes infestation. Current Controlled Trials ISRCTN88405796.

Innovating information-delivery for potential clinical trials participants. What do patients want from multi-media resources?

PubMed

Shneerson, Catherine; Windle, Richard; Cox, Karen

2013-01-01

To discover whether the provision of clinical trials information via a multi-media platform could better meet the needs, preferences and practices of potential cancer trial participants. A mixed qualitative and quantitative questionnaire was delivered to 72 participants from cancer support groups to elicit views on the provision and design features of multimedia resources in delivering clinical trials information. Perceived lack of information is an expressed barrier to clinical trials participation. Multimedia resources were viewed positively as a way to address this barrier by most potential clinical trials participants; in particular by helping to align information to individual needs, promote active engagement with information, and by allowing more control of the learning experience. Whilst text remained the most valued attribute of any resource, other highly rated attributes included the resource being simple to use, easily accessible, having a clear focus, incorporating examples and visual aids, and being interactive. Provision of support for the learning resource was also rated highly. As in other areas, such as education, multimedia resources may enhance the delivery and acceptance of information regarding clinical trials. Better alignment of information may have a positive impact on recruitment and retention into clinical trials. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

[Selective attention and schizophrenia before the administration of neuroleptics].

PubMed

Lussier, I; Stip, E

1999-01-01

In recent years, the presence of attention deficits has been recognized as a key feature of schizophrenia. Past studies reveal that selective attention, or the ability to select relevant information while ignoring simultaneously irrelevant information, is disturbed in schizophrenic patients. According to Treisman feature-integration theory of selective attention, visual search for conjunctive targets (e.g., shape and color) requires controlled processes, that necessitate attention and operate in a serial manner. Reaction times (RTs) are therefore function of the number of stimuli in the display. When subjects are asked to detect the presence or absence of a target in an array of a variable number of stimuli, different performance patterns are expected for positive (present target) and negative trials (absent target). For positive trials, a self-terminating search is triggered, that is, the search is ended when the target is encountered. For negative trials, an exhaustive search strategy is displayed, where each stimulus is examined before the search can end; the RT slope pattern is thus double that of the positive trials. To assess the integrity of these processes, thirteen drug naive schizophrenic patients were compared to twenty normal control subjects. Neuroleptic naive patients were chosen as subjects to avoid the potential influence of medication and chronicity-related factors on performance. The subjects had to specify as fast as possible the presence or absence of the target in an array of a variable number of stimuli presented in a circular display, and comprising or not the target. Results showed that the patients can use self-terminating search strategies as well as normal control subjects. However, their ability to trigger exhaustive search strategies is impaired. Not only were patients slower than controls, but their pattern of RT results was different. These results argue in favor of an early impairment in selective attention capacities in schizophrenia, which appears before the introduction of neuroleptics. The attention performance was also shown to present some association to clinical symptoms.

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial.

PubMed

van den Dool, Joost; Visser, Bart; Koelman, J Hans T M; Engelbert, Raoul H H; Tijssen, Marina A J

2013-07-15

Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Number Dutch Trial registration (Nederlands Trial Register): NTR3437.

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.

Balance training and center-of-pressure location in participants with chronic ankle instability.

PubMed

Mettler, Abby; Chinn, Lisa; Saliba, Susan A; McKeon, Patrick O; Hertel, Jay

2015-04-01

Chronic ankle instability (CAI) occurs in some people after a lateral ankle sprain and often results in residual feelings of instability and episodes of the ankle's giving way. Compared with healthy people, patients with CAI demonstrated poor postural control and used a more anteriorly and laterally positioned center of pressure (COP) during a single-limb static-balance task on a force plate. Balance training is an effective means of altering traditional COP measures; however, whether the overall location of the COP distribution under the foot also changes is unknown. To determine if the spatial locations of COP data points in participants with CAI change after a 4-week balance-training program. Randomized controlled trial. Laboratory. Thirty-one persons with self-reported CAI. Participants were randomly assigned to a 4-week balance-training program or no balance training. We collected a total of 500 COP data points while participants balanced using a single limb on a force plate during a 10-second trial. The location of each COP data point relative to the geometric center of the foot was determined, and the frequency count in 4 sections (anteromedial, anterolateral, posteromedial, posterolateral) was analyzed for differences between groups. Overall, COP position in the balance-training group shifted from being more anterior to less anterior in both eyes-open trials (before trial = 319.1 ± 165.4, after trial = 160.5 ± 149.5; P = .006) and eyes-closed trials (before trial = 387.9 ± 123.8, after trial = 189.4 ± 102.9; P < .001). The COP for the group that did not perform balance training remained the same in the eyes-open trials (before trial = 214.1 ± 193.3, after trial = 230.0 ± 176.3; P = .54) and eyes-closed trials (before trial = 326.9 ± 134.3, after trial = 338.2 ± 126.1; P = .69). In participants with CAI, the balance-training program shifted the COP location from anterolateral to posterolateral. The program may have repaired some of the damaged sensorimotor system pathways, resulting in a more optimally functioning and less constrained system.

Utterance-final position and pitch marking aid word learning in school-age children

PubMed Central

Laaha, Sabine; Fitch, W. Tecumseh

2017-01-01

We investigated the effects of word order and prosody on word learning in school-age children. Third graders viewed photographs belonging to one of three semantic categories while hearing four-word nonsense utterances containing a target word. In the control condition, all words had the same pitch and, across trials, the position of the target word was varied systematically within each utterance. The only cue to word–meaning mapping was the co-occurrence of target words and referents. This cue was present in all conditions. In the Utterance-final condition, the target word always occurred in utterance-final position, and at the same fundamental frequency as all the other words of the utterance. In the Pitch peak condition, the position of the target word was varied systematically within each utterance across trials, and produced with pitch contrasts typical of infant-directed speech (IDS). In the Pitch peak + Utterance-final condition, the target word always occurred in utterance-final position, and was marked with a pitch contrast typical of IDS. Word learning occurred in all conditions except the control condition. Moreover, learning performance was significantly higher than that observed with simple co-occurrence (control condition) only for the Pitch peak + Utterance-final condition. We conclude that, for school-age children, the combination of words' utterance-final alignment and pitch enhancement boosts word learning. PMID:28878961

Utterance-final position and pitch marking aid word learning in school-age children.

PubMed

Filippi, Piera; Laaha, Sabine; Fitch, W Tecumseh

2017-08-01

We investigated the effects of word order and prosody on word learning in school-age children. Third graders viewed photographs belonging to one of three semantic categories while hearing four-word nonsense utterances containing a target word. In the control condition, all words had the same pitch and, across trials, the position of the target word was varied systematically within each utterance. The only cue to word-meaning mapping was the co-occurrence of target words and referents. This cue was present in all conditions. In the Utterance-final condition, the target word always occurred in utterance-final position, and at the same fundamental frequency as all the other words of the utterance. In the Pitch peak condition, the position of the target word was varied systematically within each utterance across trials, and produced with pitch contrasts typical of infant-directed speech (IDS). In the Pitch peak + Utterance-final condition, the target word always occurred in utterance-final position, and was marked with a pitch contrast typical of IDS. Word learning occurred in all conditions except the control condition. Moreover, learning performance was significantly higher than that observed with simple co-occurrence ( control condition) only for the Pitch peak + Utterance-final condition. We conclude that, for school-age children, the combination of words' utterance-final alignment and pitch enhancement boosts word learning.

Impact of a Mental Health Curriculum on Knowledge and Stigma Among High School Students: A Randomized Controlled Trial.

PubMed

Milin, Robert; Kutcher, Stanley; Lewis, Stephen P; Walker, Selena; Wei, Yifeng; Ferrill, Natasha; Armstrong, Michael A

2016-05-01

This study evaluated the effectiveness of a school-based mental health literacy intervention for adolescents on knowledge and stigma. A total of 24 high schools and 534 students in the regional area of Ottawa, Ontario, Canada participated in this randomized controlled trial. Schools were randomly assigned to either the curriculum or control condition. The curriculum was integrated into the province's grade 11 and 12 "Healthy Living" courses and was delivered by teachers. Changes in mental health knowledge and stigma were measured using pre- and posttest questionnaires. Descriptive analyses were conducted to provide sample characteristics, and multilevel modeling was used to examine study outcomes. For the curriculum condition, there was a significant change in stigma scores over time (p = .001), with positive attitudes toward mental illness increasing from pre to post. There was also a significant change in knowledge scores over time (p < .001), with knowledge scores increasing from pre to post. No significant changes in knowledge or stigma were found for participants in the control condition. A meaningful relationship was found whereby increases in knowledge significantly predicted increases in positive attitudes toward mental health (p < .001). This is the first large randomized controlled trial to demonstrate the effectiveness in mental health literacy of an integrated, manualized mental health educational resource for high school students on knowledge and stigma. Findings also support the applicability by teachers and suggest the potential for broad-based implementation of the educational curriculum in high schools. Replication and further studies are warranted. Clinical trial registration information-Impact of a Mental Health Curriculum for High School Students on Knowledge and Stigma; http://clinicaltrials.gov/; NCT02561780. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Gas insufflation of minimal preparation CT of the colon reduces false-positives

PubMed Central

Slater, A; North, M; Hart, M; Ferrett, C

2012-01-01

Objectives Minimal preparation CT of the colon (MPCT colon) is used for investigation of suspected colorectal cancer in frail and/or elderly patients who would be expected to tolerate laxative bowel preparation poorly. Although it has good sensitivity for colorectal cancer it has a poor specificity. We wished to investigate whether distension of the colon with carbon dioxide alone would reduce the number of false-positives, but without making the test arduous or excessively uncomfortable. Methods 134 patients were recruited and underwent MPCT colon with gas insufflation and antispasmodics. Results were compared with a cohort of 134 patients undergoing standard protocol MPCT colon. The numbers of false-positives were compared, as was reader confidence. All trial patients were given a questionnaire documenting their experience. Results The number of false-positives was 15% in the control group and 5% in the trial group; this difference was statistically significant, (p=0.01). Reader confidence was increased in the trial group. Patient tolerance was good, with 95% saying they would have the test again. Conclusion Use of gas insufflation and antispasmodics reduces the false-positives from 15% to 5% without adversely affecting patient tolerance. PMID:21224295

Controlled Trials in Children: Quantity, Methodological Quality and Descriptive Characteristics of Pediatric Controlled Trials Published 1948-2006

PubMed Central

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P.

2010-01-01

Background The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. Methodology/Principal Findings We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). Conclusions/Significance The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials. PMID:20927344

Effect of an E-mental Health Approach to Workers' Health Surveillance versus Control Group on Work Functioning of Hospital Employees: A Cluster-RCT

PubMed Central

Ketelaar, Sarah M.; Nieuwenhuijsen, Karen; Gärtner, Fania R.; Bolier, Linda; Smeets, Odile; Sluiter, Judith K.

2013-01-01

Objective To evaluate an e-mental health (EMH) approach to workers' health surveillance (WHS) targeting work functioning (WF) and mental health (MH) of healthcare professionals in a randomised controlled trial. Methods Nurses and allied health professionals (N = 1140) were cluster-randomised at ward level to the intervention (IG) or control group (CG). The intervention consisted of two parts: (a) online screening and personalised feedback on impaired WF and MH, followed by (b) a tailored offer of self-help EMH interventions. CG received none of these parts. Primary outcome was impaired WF (Nurses Work Functioning Questionnaire), assessed at baseline and after three and six months. Analyses were performed in the positively screened subgroup (i) and in all participants (ii). Results Participation rate at baseline was 32% (NIG = 178; NCG = 188). Eighty-two percent screened positive for at least mild impairments in WF and/or MH (NIG = 139; NCG = 161). All IG-participants (N = 178) received part (a) of the intervention, nine participants (all positively screened, 6%) followed an EMH intervention to at least some extent. Regarding the subgroup of positively screened participants (i), both IG and CG improved over time regarding WF (non-significant between-group difference). After six months, 36% of positively screened IG-participants (18/50) had a relevant WF improvement compared to baseline, versus 28% (32/115) of positively screened CG-participants (non-significant difference). In the complete sample (ii), IG and CG improved over time but IG further improved between three and six months while CG did not (significant interaction effect). Conclusions In our study with a full compliance rate of 6% and substantial drop-out leading to a small and underpowered sample, we could not demonstrate that an EMH-approach to WHS is more effective to improve WF and MH than a control group. The effect found in the complete sample of participants is not easily interpreted. Reported results may be useful for future meta-analytic work. Trial Registration Dutch Trial Register NTR2786 PMID:24069148

The role of the anterior cingulate cortex in the affective evaluation of conflict

PubMed Central

Braem, Senne; King, Joseph A.; Korb, Franziska M.; Krebs, Ruth M.; Notebaert, Wim; Egner, Tobias

2017-01-01

An influential theory of anterior cingulate cortex (ACC) function argues that this brain region plays a crucial role in the affective evaluation of performance monitoring and control demands. Specifically, control-demanding processes such as response conflict, are thought to be registered as aversive signals by the ACC, which in turn triggers processing adjustments to support avoidance-learning. In support of conflict being treated as an aversive event, recent behavioural studies demonstrated that incongruent (i.e., conflict-inducing) relative to congruent stimuli can speed up subsequent negative relative to positive affective picture processing. Here, we used functional magnetic resonance imaging (fMRI) to investigate directly whether ACC activity in response to negative versus positive pictures is modulated by preceding control demands, consisting of conflict and task-switching conditions. The results show that negative relative to positive pictures elicited higher ACC activation following congruent relative to incongruent trials, suggesting that the ACC’s response to negative (positive) pictures was indeed affectively primed by incongruent (congruent) trials. Interestingly, this pattern of results was observed on task repetitions, but disappeared on task alternations. Our findings support the proposal that conflict induces negative affect, and are the first to show that this affective signal is reflected in ACC activation. PMID:27575278

Interference Resolution in Emotional Working Memory as a Function of Alexithymia.

PubMed

Colligan, Sean M; Koven, Nancy S

2015-01-01

Although alexithymia is recognized as a set of traitlike deficits in emotion processing, research suggests there are concomitant cognitive issues as well, including what appears to be an unusual pattern of enhanced working memory (WM) despite broader executive dysfunction. It is unknown whether this enhancement includes the executive elements of WM and whether executive control of WM in alexithymia differs for emotional and neutral stimuli. This study examined how alexithymia moderates patterns of interference resolution in WM with valenced and nonvalenced stimuli. Participants (N = 93) completed the Toronto Alexithymia Scale and a recency probes WM task containing positive, negative, and neutral stimuli, with some trials containing proactive interference from previous trials. The reaction time difference between interference and noninterference trials indexed degree of interference resolution. Toronto Alexithymia Scale score moderated a within-subject effect such that, when valenced probes were used, there was less proactive interference in the positive relative to negative valence condition; this valence-based interference discrepancy was significant for a subset of highly alexithymic participants. Alexithymia did not moderate proactive interference to negative or neutral stimuli or accuracy of responses. These results suggest that, although alexithymia does not influence executive control in WM for nonemotional items, alexithymic people demonstrate an idiosyncratic response to positive stimuli that might indicate blunted reactivity.

Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft.

PubMed

Freitas, E R F S; Soares, B G O; Cardoso, J R; Atallah, A N

2007-07-18

Following coronary artery bypass graft (CABG), the main causes of postoperative morbidity and mortality are postoperative pulmonary complications, respiratory dysfunction and arterial hypoxemia. Incentive spirometry is a treatment technique that uses a mechanical device (an incentive spirometer) to reduce such pulmonary complications during postoperative care. To assess the effects of incentive spirometry for preventing postoperative pulmonary complications in adults undergoing CABG. We searched CENTRAL on The Cochrane Library (Issue 2, 2004), MEDLINE (1966 to December 2004), EMBASE (1980 to December 2004), LILACS (1982 to December 2004), the Physiotherapy Evidence Database (PEDro) (1980 to December 2004), Allied & Complementary Medicine (AMED) (1985 to December 2004), CINAHL (1982 to December 2004), and the Database of Abstracts of Reviews of Effects (DARE) (1994 to December 2004). References were checked and authors contacted. No language restrictions were applied. Randomized controlled trials comparing incentive spirometry with any type of prophylactic physiotherapy for prevention of postoperative pulmonary complications in adults undergoing CABG. Two reviewers independently evaluated the quality of trials using the guidelines of the Cochrane Reviewers' Handbook and extracted data from included trials. Four trials with 443 participants contributed to this review. There was no significant difference in pulmonary complications (atelectasis and pneumonia) between treatment with incentive spirometry and treatment with positive pressure breathing techniques (continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and intermittent positive pressure breathing (IPPB)) or preoperative patient education. Patients treated with incentive spirometry had worse pulmonary function and arterial oxygenation compared with positive pressure breathing (CPAP, BiPAP, IPPB). Individual small trials suggest that there is no evidence of benefit from incentive spirometry in reducing pulmonary complications and in decreasing the negative effects on pulmonary function in patients undergoing CABG. In view of the modest number of patients studied, methodological shortcomings and poor reporting of the included trials, these results should be interpreted cautiously. An appropriately powered trial of high methodological rigour is needed to determine those patients who may derive benefit from incentive spirometry following CABG.

A randomized controlled trial of mindfulness meditation versus relaxation training: effects on distress, positive states of mind, rumination, and distraction.

PubMed

Jain, Shamini; Shapiro, Shauna L; Swanick, Summer; Roesch, Scott C; Mills, Paul J; Bell, Iris; Schwartz, Gary E R

2007-02-01

Although mindfulness meditation interventions have recently shown benefits for reducing stress in various populations, little is known about their relative efficacy compared with relaxation interventions. This randomized controlled trial examines the effects of a 1-month mindfulness meditation versus somatic relaxation training as compared to a control group in 83 students (M age = 25; 16 men and 67 women) reporting distress. Psychological distress, positive states of mind, distractive and ruminative thoughts and behaviors, and spiritual experience were measured, while controlling for social desirability. Hierarchical linear modeling reveals that both meditation and relaxation groups experienced significant decreases in distress as well as increases in positive mood states over time, compared with the control group (p < .05 in all cases). There were no significant differences between meditation and relaxation on distress and positive mood states over time. Effect sizes for distress were large for both meditation and relaxation (Cohen's d = 1.36 and .91, respectively), whereas the meditation group showed a larger effect size for positive states of mind than relaxation (Cohen's d =.71 and .25, respectively). The meditation group also demonstrated significant pre-post decreases in both distractive and ruminative thoughts/behaviors compared with the control group (p < .04 in all cases; Cohen's d = .57 for rumination and .25 for distraction for the meditation group), with mediation models suggesting that mindfulness meditation's effects on reducing distress were partially mediated by reducing rumination. No significant effects were found for spiritual experience. The data suggest that compared with a no-treatment control, brief training in mindfulness meditation or somatic relaxation reduces distress and improves positive mood states. However, mindfulness meditation may be specific in its ability to reduce distractive and ruminative thoughts and behaviors, and this ability may provide a unique mechanism by which mindfulness meditation reduces distress.

Interventions in the workplace to support breastfeeding for women in employment.

PubMed

Abdulwadud, Omar A; Snow, Mary Elizabeth

2012-10-17

In recent years there has been a rise in the participation rate of women in employment. Some may become pregnant while in employment and subsequently deliver their babies. Most may decide to return early to work after giving birth for various reasons. Unless these mothers get support from their employers and fellow employees, they might give up breastfeeding when they return to work. As a result, the duration and exclusivity of breastfeeding to the recommended age of the babies would be affected.Workplace environment can play a positive role to promote breastfeeding. For women going back to work, various types of workplace support interventions are available and this should not be ignored by employers. Notably, promoting breastfeeding in a workplace may have benefits for the women, the baby and also the employer. To assess the effectiveness of workplace interventions to support and promote breastfeeding among women returning to paid work after the birth of their children, and its impact on process outcomes pertinent to employees and employers. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 August 2012). Two authors independently assessed all identified studies for randomised controlled trials and quasi-randomised controlled trials that compared workplace interventions with no intervention or two or more workplace interventions against each other. Two authors planned to evaluate the methodological quality of the eligible trials and extract data. There were no randomised controlled trials or quasi-randomised controlled trials identified. No trials have evaluated the effectiveness of workplace interventions in promoting breastfeeding among women returning to paid work after the birth of their child. The impact of such intervention on process outcomes is also unknown. Randomised controlled trials are required to establish the benefits of various types of workplace interventions to support, encourage and promote breastfeeding among working mothers.

Comparison of Breastfeeding Outcomes Between Using the Laid-Back and Side-Lying Breastfeeding Positions in Mothers Delivering by Cesarean Section: A Randomized Controlled Trial.

PubMed

Puapornpong, Pawin; Raungrongmorakot, Kasem; Laosooksathit, Wipada; Hanprasertpong, Tharangrut; Ketsuwan, Sukwadee

2017-05-01

The breastfeeding position routinely used following a cesarean section is the side-lying position. However, there have been few studies about the effect of breastfeeding positions, including laid-back position on breastfeeding outcomes. To compare the breastfeeding outcomes between using laid-back and side-lying breastfeeding positions in mothers delivering by cesarean section. A randomized controlled trial was conducted. The postpartum mothers delivering by cesarean section who delivered term newborns were randomly assigned to learn the use of a laid-back or side-lying breastfeeding position. The breastfeeding outcomes were assessed by LATCH scores at the second day postpartum and exclusive breastfeeding rates during the 6-week postpartum period. The mother's satisfaction of each breastfeeding position was collected before discharge from the hospital. The data from 152 postpartum mothers delivering by cesarean section were available for analysis, 76 from the laid-back position group and 76 from side-lying position group. The baseline characteristics of both groups were similar. There were no statistically significant differences of the breastfeeding outcomes, LATCH scores at the second day postpartum and the exclusive breastfeeding rates during the 6-week postpartum period. But the mothers had expressed more satisfaction from the side-lying than the laid-back position. Among the mothers who delivered by cesarean section, the use of the laid-back breastfeeding position had not shown different breastfeeding outcomes from the side-lying breastfeeding position. It might be an alternative breastfeeding position, which can be taught for mothers delivering by cesarean section along with the side-lying position.

Comparison of anchorage capacity between implant and headgear during anterior segment retraction.

PubMed

Li, F; Hu, H K; Chen, J W; Liu, Z P; Li, G F; He, S S; Zou, S J; Ye, Q S

2011-09-01

To compare the anchorage effects of the implants and the headgear for patients with anterior teeth retraction in terms of incisor retraction, anchorage loss, inclination of maxillary incisors, positional change of maxillary basal bone, and treatment duration. An electronic search for relative randomized controlled trials (RCTs) prospective and retrospective controlled trials was done through the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, Medline, and CNKI, regardless of language of study. Study selection, methodological quality assessment, and data extraction were performed by two reviewers independently. Meta-analysis was performed when possible; otherwise descriptive assessment was done. The search yielded 35 articles, of which eight met the inclusion criteria and were categorized into five groups according to types of intervention. For the midpalatal implant, the anchorage loss was much less than for the headgear group, with insignificant differences in terms of anterior teeth retraction, maxillary incisor inclination, positional change of basal bone, and treatment duration. For the mini-implant, greater anterior teeth retraction and less anchorage loss were demonstrated, with inconsistent results for the other measures. For the onplant, less anchorage loss was noted, with insignificant differences for the other measures. The skeletal anchorage of the midpalatal implant, mini-implant, and onplant offer better alternatives to headgear, with less anchorage loss and more anterior teeth retraction. There were inconsistent results from the included studies in terms of maxillary incisor inclination, positional change of maxillary basal bone, and treatment duration. More qualified RCTs are required to provide clear recommendations.

Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach.

PubMed

Cowan, James F; Micek, Mark; Cowan, Jessica F Greenberg; Napúa, Manuel; Hoek, Roxanne; Gimbel, Sarah; Gloyd, Stephen; Sherr, Kenneth; Pfeiffer, James T; Chapman, Rachel R

2015-04-30

Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended "Option B+" strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy. This study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care. This pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa. ClinicalTrials.gov: NCT02371265.

Quality control in the diagnosis of Trichuris trichiura and Ascaris lumbricoides using the Kato-Katz technique: experience from three randomised controlled trials.

PubMed

Speich, Benjamin; Ali, Said M; Ame, Shaali M; Albonico, Marco; Utzinger, Jürg; Keiser, Jennifer

2015-02-05

An accurate diagnosis of soil-transmitted helminthiasis is important for individual patient management, for drug efficacy evaluation and for monitoring control programmes. The Kato-Katz technique is the most widely used method detecting soil-transmitted helminth eggs in faecal samples. However, detailed analyses of quality control, including false-positive and faecal egg count (FEC) estimates, have received little attention. Over a 3-year period, within the frame of a series of randomised controlled trials conducted in Pemba, United Republic of Tanzania, 10% of randomly selected Kato-Katz thick smears were re-read for Trichuris trichiura and Ascaris lumbricoides eggs. In case of discordant result (i.e. positive versus negative) the slides were re-examined a third time. A result was assumed to be false-positive or false-negative if the result from the initial reading did not agree with the quality control as well as the third reading. We also evaluated the general agreement in FECs between the first and second reading, according to internal and World Health Organization (WHO) guidelines. From the 1,445 Kato-Katz thick smears subjected to quality control, 1,181 (81.7%) were positive for T. trichiura and 290 (20.1%) were positive for A. lumbricoides. During quality control, very low rates of false-positive results were observed; 0.35% (n = 5) for T. trichiura and 0.28% (n = 4) for A. lumbricoides. False-negative readings of Kato-Katz thick smears were obtained in 28 (1.94%) and 6 (0.42%) instances for T. trichiura and A. lumbricoides, respectively. A high frequency of discordant results in FECs was observed (i.e. 10.0-23.9% for T. trichiura, and 9.0-11.4% for A. lumbricoides). Our analyses show that the rate of false-positive diagnoses of soil-transmitted helminths is low. As the probability of false-positive results increases after examination of multiple stool samples from a single individual, the potential influence of false-positive results on epidemiological studies and anthelminthic drug efficacy studies should be determined. Existing WHO guidelines for quality control might be overambitious and might have to be revised, specifically with regard to handling disagreements in FECs.

Effect of Hibiscus sabdariffa Calices on Dyslipidemia in Obese Adolescents: A Triple-masked Randomized Controlled Trial

PubMed Central

Sabzghabaee, Ali Mohammad; Ataei, Ehsan; Kelishadi, Roya; Ghannadi, Alireza; Soltani, Rasool; Badri, Shirinsadat; Shirani, Shahin

2013-01-01

Conflict of interest: none declared. Objective We aimed to evaluate the effects of Hibiscus sabdariffa (HS) calices on controlling dyslipidemia in obese adolescents. Methodology In this triple blind randomized placebo-controlled clinical trial which was registered in the Iranian registry for clinical trials (IRCT201109122306N2), 90 obese adolescents aged 12-18 years with documented dyslipidemia were randomly assigned in two groups of cases who received 2 grams of fine powdered calices of Hibiscus sabdariffa per day for one month and controls who received placebo powder with the same dietary and physical activity recommendations and duration of exposure. Full lipid profile and fasting blood sugar measured before and after the trial. Data were analyzed using multivariate general linear model. Findings Overall, 72 participants (mean age of 14.21±1.6, 35 boys) completed the trial. The two arms of the study (cases and controls) were not statistically different in terms of age, gender, weight, body mass index (BMI) and lipid profile before the trial. Serum total cholesterol, low density lipoprotein cholesterol and serum triglyceride showed a significant decrease in cases group but high density lipoprotein cholesterol level was not changed significantly. Conclusion It is concluded that Hibiscus sabdariffa calyces powder may have significant positive effects on lipid profile of adolescents which maybe attributed to its polyphenolic and antioxidant content. Further studies are needed on dose-response and formulation optimization. PMID:24082826

Reinforcement Learning Deficits in People with Schizophrenia Persist after Extended Trials

PubMed Central

Cicero, David C.; Martin, Elizabeth A.; Becker, Theresa M.; Kerns, John G.

2014-01-01

Previous research suggests that people with schizophrenia have difficulty learning from positive feedback and when learning needs to occur rapidly. However, they seem to have relatively intact learning from negative feedback when learning occurs gradually. Participants are typically given a limited amount of acquisition trials to learn the reward contingencies and then tested about what they learned. The current study examined whether participants with schizophrenia continue to display these deficits when given extra time to learn the contingences. Participants with schizophrenia and matched healthy controls completed the Probabilistic Selection Task, which measures positive and negative feedback learning separately. Participants with schizophrenia showed a deficit in learning from both positive and negative feedback. These reward learning deficits persisted even if people with schizophrenia are given extra time (up to 10 blocks of 60 trials) to learn the reward contingencies. These results suggest that the observed deficits cannot be attributed solely to slower learning and instead reflect a specific deficit in reinforcement learning. PMID:25172610

Reinforcement learning deficits in people with schizophrenia persist after extended trials.

PubMed

Cicero, David C; Martin, Elizabeth A; Becker, Theresa M; Kerns, John G

2014-12-30

Previous research suggests that people with schizophrenia have difficulty learning from positive feedback and when learning needs to occur rapidly. However, they seem to have relatively intact learning from negative feedback when learning occurs gradually. Participants are typically given a limited amount of acquisition trials to learn the reward contingencies and then tested about what they learned. The current study examined whether participants with schizophrenia continue to display these deficits when given extra time to learn the contingences. Participants with schizophrenia and matched healthy controls completed the Probabilistic Selection Task, which measures positive and negative feedback learning separately. Participants with schizophrenia showed a deficit in learning from both positive feedback and negative feedback. These reward learning deficits persisted even if people with schizophrenia are given extra time (up to 10 blocks of 60 trials) to learn the reward contingencies. These results suggest that the observed deficits cannot be attributed solely to slower learning and instead reflect a specific deficit in reinforcement learning. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Neural correlates of inhibitory spillover in adolescence: associations with internalizing symptoms

PubMed Central

Del Piero, Larissa; Margolin, Gayla; Kaplan, Jonas T; Saxbe, Darby E

2017-01-01

Abstract This study used an emotional go/no-go task to explore inhibitory spillover (how intentional cognitive inhibition ‘spills over’ to inhibit neural responses to affective stimuli) within 23 adolescents. Adolescents were shown emotional faces and asked to press a button depending on the gender of the face. When asked to inhibit with irrelevant affective stimuli present, adolescents recruited prefrontal cognitive control regions (rIFG, ACC) and ventral affective areas (insula, amygdala). In support of the inhibitory spillover hypothesis, increased activation of the rIFG and down-regulation of the amygdala occurred during negative, but not positive, inhibition trials compared with go trials. Functional connectivity analysis revealed coupling of the rIFG pars opercularis and ventral affective areas during negative no-go trials. Age was negatively associated with activation in frontal and temporal regions associated with inhibition and sensory integration. Internalizing symptoms were positively associated with increased bilateral IFG, ACC, putamen and pallidum. This is the first study to test the inhibitory spillover emotional go/no-go task within adolescents, who may have difficulties with inhibitory control, and to tie it to internalizing symptoms. PMID:28981903

The role of physician characteristics in clinical trial acceptance: testing pathways of influence.

PubMed

Curbow, Barbara; Fogarty, Linda A; McDonnell, Karen A; Chill, Julia; Scott, Lisa Benz

2006-03-01

Eight videotaped vignettes were developed that assessed the effects of three physician-related experimental variables (in a 2 x 2 x 2 factorial design) on clinical trial (CT) knowledge, video knowledge, information processing, CT beliefs, affective evaluations (attitudes), and CT acceptance. It was hypothesized that the physician variables (community versus academic-based affiliation, enthusiastic versus neutral presentation of the trial, and new versus previous relationship with the patient) would serve as communication cues that would interrupt message processing, leading to lower knowledge gain but more positive beliefs, attitudes, and CT acceptance. A total of 262 women (161 survivors and 101 controls) participated in the study. The manipulated variables primarily influenced the intermediary variables of post-test CT beliefs and satisfaction with information rather than knowledge or information processing. Multiple regression results indicated that CT acceptance was associated with positive post-CT beliefs, a lower level of information processing, satisfaction with information, and control status. Based on these results, CT acceptance does not appear to be based on a rational decision-making model; this has implications for both the ethics of informed consent and research conceptual models.

Using interactive voice response to improve disease management and compliance with acute coronary syndrome best practice guidelines: A randomized controlled trial.

PubMed

Sherrard, Heather; Duchesne, Lloyd; Wells, George; Kearns, Sharon Ann; Struthers, Christine

2015-01-01

There is evidence from large clinical trials that compliance with standardized best practice guidelines (BPGs) improves survival of acute coronary syndrome (ACS) patients. However, their application is often suboptimal. In this study, the researchers evaluated whether the use of an interactive voice response (IVR) follow-up system improved ACS BPG compliance. This was a single-centre randomized control trial (RCT) of 1,608 patients (IVR=803; usual care=805). The IVR group received five automated calls in 12 months. The primary composite outcome was increased medication compliance and decreased adverse events. A significant improvement of 60% in the IVR group for the primary composite outcome was found (RR 1.60, 95% CI: 1.29 to 2.00, p <0.001). There was significant improvement in medication compliance (p <0.001) and decrease in unplanned medical visits (p = 0.023). At one year, the majority of patients ( 85%) responded positively to using the system again. Follow-up by IVR produced positive outcomes in ACS patients.

A systematic review of training programmes for recruiters to randomised controlled trials.

PubMed

Townsend, Daisy; Mills, Nicola; Savović, Jelena; Donovan, Jenny L

2015-09-28

Recruitment to randomised controlled trials (RCTs) is often difficult. Clinician related factors have been implicated as important reasons for low rates of recruitment. Clinicians (doctors and other health professionals) can experience discomfort with some underlying principles of RCTs and experience difficulties in conveying them positively to potential trial participants. Recruiter training has been suggested to address identified problems but a synthesis of this research is lacking. The aim of our study was to systematically review the available evidence on training interventions for recruiters to randomised trials. Studies that evaluated training programmes for trial recruiters were included. Those that provided only general communication training not linked to RCT recruitment were excluded. Data extraction and quality assessment were completed by two reviewers independently, with a third author where necessary. Seventeen studies of 9615 potentially eligible titles and abstracts were included in the review: three randomised controlled studies, two non-randomised controlled studies, nine uncontrolled pre-test/post-test studies, two qualitative studies, and a post-training questionnaire survey. Most studies were of moderate or weak quality. Training programmes were mostly set within cancer trials, and usually consisted of workshops with a mix of health professionals over one or two consecutive days covering generic and trial specific issues. Recruiter training programmes were well received and some increased recruiters' self-confidence in communicating key RCT concepts to patients. There was, however, little evidence that this training increased actual recruitment rates or patient understanding, satisfaction, or levels of informed consent. There is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials.

[Evaluation of a trial to control Biomphalaria glabrata in Guadeloupe by using a sterilizing trematode (author's transl)].

PubMed

Nassi, H; Pointier, J P; Golvan, Y J

1979-01-01

A trial of biological control of Biomphalaria glabrata was carried out in Guadeloupe by using Ribeiroia marini guadeloupensis Nassi, 1978, an autochtonal Trematode which sterilizes the snail vector of Schistosoma mansoni. The trial took place in a pond in which the population of B. glabrata presents an annual demographic cycle related to the alternation of dry and rainy seasons. About 8 millions eggs of R. marini were introduced in 15 months into the biotope. Despite the low yield of these introductions, due particularly to the high turbidity of the water, this trial gave positive results in the disappearance of almost all the snails. The analysis of the results concerning the evolution of the levels of the snails and of the prevalence shows that a comparable efficiency could be obtained by massive introductions of eggs during short periods.

Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial.

PubMed

Meinich Petersen, Sandra; Zoffmann, Vibeke; Kjærgaard, Jesper; Graff Stensballe, Lone; Graff Steensballe, Lone; Greisen, Gorm

2014-04-15

When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial. We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets. The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants' different positions along two continuities from 'Our participation in trial is not important' to 'Our participation in trial is important', and 'Vaccine not important to us' to 'Vaccine important to us'. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study. This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The trial staff might use the model of reactions in understanding the parents' disappointment and in this way support their motives for participation. A generalized version might be applicable across randomized controlled trials at large. The Calmette study is registered in EudraCT (https://eudract.ema.europa.eu/) with trial number 2010-021979-85.

"Familias: Preparando La Nueva Generación": A Randomized Control Trial Testing the Effects on Positive Parenting Practices

ERIC Educational Resources Information Center

Marsiglia, Flavio F.; Williams, Lela Rankin; Ayers, Stephanie L.; Booth, Jaime M.

2014-01-01

Objectives: This article reports the effects of a culturally grounded parenting intervention to strengthen positive parenting practices. Method: The intervention was designed and tested with primarily Mexican origin parents in a large urban setting of the southwestern United States using an ecodevelopmental approach. Parents (N = 393) were…

Motivational Interviewing (MINT) Improves Continuous Positive Airway Pressure (CPAP) Acceptance and Adherence: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Olsen, Sara; Smith, Simon S.; Oei, Tian P. S.; Douglas, James

2012-01-01

Objective: Adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea (OSA) is poor. We assessed the effectiveness of a motivational interviewing intervention (motivational interview nurse therapy [MINT]) in addition to best practice standard care to improve acceptance and adherence to CPAP therapy in people with…

The Dose That Works: Low Level Laser Treatment of Tendinopathy

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

Tumilty, Steve; Munn, Joanne; David Baxter, G.

2010-05-31

Background: Low Level Laser Therapy (LLLT) is used in the treatment of tendon injuries. However, the clinical effectiveness of this modality remains controversial with limited agreement on the most efficacious dosage and parameter choices. Purpose: To assess the clinical effectiveness of LLLT in the treatment of tendinopathy and the validity of current dosage recommendations for treatment. Method: Medical databases were searched from inception to 1st August 2008. Controlled clinical trials evaluating LLLT as a primary intervention for any tendinopathy were included in the review. Methodological quality was classified using the PEDro scale. Appropriateness of treatment parameters were assessed using establishedmore » guidelines. Results: Twenty five trials met the inclusion criteria. There was conflicting findings from multiple trials: 12 showed positive effects and 13 were inconclusive or showed no effect. Dosages used in the 12 positive studies support the existence of an effective dosage window that closely resembled current guidelines. Where pooling of data was possible, LLLT showed a positive effect size; in high quality studies of lateral epicondylitis, participants' grip strength was 9.59 Kg higher than the control group; for participants with Achilles tendinopathy, the effect was 13.6 mm less pain on a 100 mm visual analogue scale. Conclusion: This study found conflicting evidence as to the effectiveness of LLLT in the treatment of tendinopathy. However, an effective dosage window emerged showing benefit in the treatment of tendinopathy. Strong evidence exists from the 12 positive studies that positive outcomes are associated with the use of current dosage recommendations for the treatment of tendinopathy.« less

The Dose That Works: Low Level Laser Treatment of Tendinopathy

NASA Astrophysics Data System (ADS)

Tumilty, Steve; Munn, Joanne; McDonough, Suzanne; Hurley, Deirdre A.; Basford, Jeffrey R.; David Baxter, G.

2010-05-01

Background: Low Level Laser Therapy (LLLT) is used in the treatment of tendon injuries. However, the clinical effectiveness of this modality remains controversial with limited agreement on the most efficacious dosage and parameter choices. Purpose: To assess the clinical effectiveness of LLLT in the treatment of tendinopathy and the validity of current dosage recommendations for treatment. Method: Medical databases were searched from inception to 1st August 2008. Controlled clinical trials evaluating LLLT as a primary intervention for any tendinopathy were included in the review. Methodological quality was classified using the PEDro scale. Appropriateness of treatment parameters were assessed using established guidelines. Results: Twenty five trials met the inclusion criteria. There was conflicting findings from multiple trials: 12 showed positive effects and 13 were inconclusive or showed no effect. Dosages used in the 12 positive studies support the existence of an effective dosage window that closely resembled current guidelines. Where pooling of data was possible, LLLT showed a positive effect size; in high quality studies of lateral epicondylitis, participants' grip strength was 9.59 Kg higher than the control group; for participants with Achilles tendinopathy, the effect was 13.6 mm less pain on a 100 mm visual analogue scale. Conclusion: This study found conflicting evidence as to the effectiveness of LLLT in the treatment of tendinopathy. However, an effective dosage window emerged showing benefit in the treatment of tendinopathy. Strong evidence exists from the 12 positive studies that positive outcomes are associated with the use of current dosage recommendations for the treatment of tendinopathy.

[Testosterone replacement therapy and cardiovascular risk].

PubMed

Corona, Giovanni; Dicuio, Mauro; Rastrelli, Giulia; Sforza, Alessandra; Maggi, Mario

2017-11-01

Late onset hypogonadism (LOH) is the most commonly used term to indicate the age-dependent reduction of testosterone. Sexual dysfunction represents the most important determinant for medical consultation and the most specific symptoms associated with LOH. In particular, data from the European Male Ageing Study (EMAS), a population-based survey on more than 3400 subjects, recognized that a triad of sexual symptoms (low libido and reduced spontaneous and sex-related erections) is the only syndromic association with decreased testosterone levels. Accordingly, a meta-analysis of the available randomized controlled trials documented that testosterone therapy (TTh) is able to improve all aspects of sexual function when compared to placebo. Despite this evidence, however, the relative clinical significance and the potential benefit of TTh in LOH are still the subject of strong criticisms in the scientific community. The debate is further complicated by the recent position statement of the US Food and Drug Administration (FDA) emphasizing a possible increased cardiovascular risk of TTh. However, this position was not endorsed by the European Medicines Association (EMA), which reached an opposite position after a specific review of the available data. In this review, all the conflicting data supporting the different positions of the FDA and EMA will be discussed. In particular, data derived from either population-based studies or interventional trials will be analyzed in detail. Although some evidence suggests an increase in TTh-related cardiovascular risk, the data derived from controlled trials do not support this position especially when the incidence of major adverse cardiovascular events are considered. Symptomatic men with documented reduced testosterone levels can be safely treated with TTh.

Effectiveness of the Epley’s maneuver performed in primary care to treat posterior canal benign paroxysmal positional vertigo: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Vertigo is a common medical condition with a broad spectrum of diagnoses which requires an integrated approach to patients through a structured clinical interview and physical examination. The main cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV), which should be confirmed by a positive D-H positional test and treated with repositioning maneuvers. The objective of this study is to evaluate the effectiveness of Epley’s maneuver performed by general practitioners (GPs) in the treatment of BPPV. Methods/Design This study is a randomized clinical trial conducted in the primary care setting. The study’s scope will include two urban primary care centers which provide care for approximately 49,400 patients. All patients attending these two primary care centers, who are newly diagnosed with benign paroxysmal positional vertigo, will be invited to participate in the study and will be randomly assigned either to the treatment group (Epley’s maneuver) or to the control group (a sham maneuver). Both groups will receive betahistine. Outcome variables will be: response to the D-H test, patients’ report on presence or absence of vertigo during the previous week (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert-type scale in the previous week, total score on the Dizziness Handicap Inventory (DHI) and quantity of betahistine taken. We will use descriptive statistics of all variables collected. Groups will be compared using the intent-to-treat approach and either parametric or nonparametric tests, depending on the nature and distribution of the variables. Chi-square test or Fisher’s exact test will be conducted to compare categorical measures and Student’s t-test or Mann–Whitney U-test will be used for intergroup comparison variables. Discussion Positive results from our study will highlight that treatment of benign paroxysmal positional vertigo can be performed by trained general practitioners (GPs) and, therefore, its widespread practice may contribute to improve the quality of life of BPPV patients. Trial registration ClinicalTrials.gov Identifier: NCT01969513. PMID:24886338

Physical activity, menopause, and quality of life: the role of affect and self-worth across time.

PubMed

Elavsky, Steriani

2009-01-01

Physical activity has been shown to enhance quality of life (QOL); however, few investigations of these effects exist in women undergoing the menopausal transition. The present study examined the long-term effects of physical activity on menopause-related QOL and tested the mediating effects of physical self-worth and positive affect in this relationship. Middle-aged women previously enrolled in a 4-month randomized controlled trial involving walking and yoga, and a control group completed a follow-up mail-in survey 2 years after the end of the trial. The survey included a battery of psychological and physical activity measures, including measures of menopausal symptoms and menopause-related QOL. Longitudinal linear panel analysis was conducted within a covariance modeling framework to test whether physical self-worth and positive affect mediated the physical activity-QOL relationship over time. At the end of the trial, physical activity and menopausal symptoms were related to physical self-worth and positive affect, and in turn, greater levels of physical self-worth and positive affect were associated with higher levels of menopause-related QOL. Analyses indicated that increases in physical activity and decreases in menopausal symptoms over the 2-year period were related to increases in physical self-worth (betas = 0.23 and -0.52, physical activity and menopausal symptoms, respectively) and, for symptoms, also to decreased positive affect (beta = -0.47), and both physical self-worth (beta = 0.34) and affect (beta = 0.43) directly influenced enhancements in QOL (R = 0.775). The findings support the position that the effects of physical activity on QOL are mediated, in part, by intermediate psychological outcomes and that physical activity can have long-term benefits for women undergoing the menopausal transition.

POSITIVE study: physical exercise program in non-operable lung cancer patients undergoing palliative treatment.

PubMed

Wiskemann, Joachim; Hummler, Simone; Diepold, Christina; Keil, Melanie; Abel, Ulrich; Steindorf, Karen; Beckhove, Philipp; Ulrich, Cornelia M; Steins, Martin; Thomas, Michael

2016-07-19

Patients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment. Therefore, the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a randomized controlled setting. The POSITIVE study is a randomized, controlled trial investigating the effects of a 24-week exercise intervention during palliative treatment on quality of life, physical performance and immune function in advanced, non-operable lung cancer patients. 250 patients will be recruited in the Clinic for Thoracic Diseases in Heidelberg, enrolment begun in November 2013. Main inclusion criterion is histologically confirmed NSCLC (stage IIIa, IIIb, IV) or SCLC (Limited Disease-SCLC, Extensive Disease-SCLC) not amenable to surgery. Patients are randomized into two groups. Both groups receive weekly care management phone calls (CMPCs) with the goal to assess symptoms and side effects. Additionally, one group receives a combined resistance and endurance training (3x/week). Primary endpoints are quality of life assessed by the Functional Assessment of Cancer Therapy for patients with lung cancer (FACT-L, subcategory Physical Well-Being) and General Fatigue measured by the Multidimensional Fatigue Inventory (MFI-20). Secondary endpoints are physical performance (maximal voluntary isometric contraction, 6-min walk distance), psychosocial (depression and anxiety) and immunological parameters and overall survival. The aim of the POSITIVE trial is the evaluation of effects of a 24-week structured and guided exercise intervention during palliative treatment stages. Analysis of various outcomes (such as quality of life, physical performance, self-efficacy, psychosocial and immunological parameters) will contribute to a better understanding of the potential of exercise in advanced lung cancer patients. In contrast to other studies with advanced oncological patients the POSITIVE trial provides weekly phone calls to support patients both in the intervention and control group and to segregate the impact of physical activity on quality of life. ClinicalTrials.gov NCT02055508 (Date: December 12, 2013).

History and present status of pulmonary metastasectomy in colorectal cancer.

PubMed

Treasure, Tom; Milošević, Mišel; Fiorentino, Francesca; Pfannschmidt, Joachim

2014-10-28

Clinical practice with respect to metastatic colorectal cancer differs from the other two most common cancers, breast and lung, in that routine surveillance is recommended with the specific intent of detecting liver and lung metastases and undertaking liver and lung resections for their removal. We trace the history of this approach to colorectal cancer by reviewing evidence for effectiveness from the 1950s to the present day. Our sources included published citation network analyses, the documented proposal for randomised trials, large systematic reviews, and meta-analysis of observational studies. The present consensus position has been adopted on the basis of a large number of observational studies but the randomised trials proposed in the 1980s and 1990s were either not done, or having been done, were not reported. Clinical opinion is the mainstay of current practice but in the absence of randomised trials there remains a possibility of selection bias. Randomised controlled trials (RCTs) are now routine before adoption of a new practice but RCTs are harder to run in evaluation of already established practice. One such trial is recruiting and shows that controlled trial are possible.

[Clinical trials registry].

PubMed

Ryder, Elena

2004-12-01

Authors and journals are more enthusiastic about the publication of trials with positive results than those negative or inconclusive trials. The International Committee of Medical Journal Editors proposed comprehensive trials registration as a solution to the problem of selective awareness and announces that the ICMJE member journals will adopt a trial-registration policy to promote this goal. They establish as a condition of consideration for publication, registration in a public trials registry. They recommend registries that meet certain criteria as www.clinicaltrials.com. Among those criteria is that the registry must be supported by a non-profit organization. On the other hand, people from Current Controlled Trials Ltd. being a commercial company, but meeting all the other criteria established by the ICMJE, feel that is being put aside. We wonder if clinical trials in our country are being registered in some of these International Registries. If not, would it be time to do so?

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial.

PubMed

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.

A pilot randomized placebo-controlled trial of adjunctive aripiprazole for chronic PTSD in US military Veterans resistant to antidepressant treatment.

PubMed

Naylor, Jennifer C; Kilts, Jason D; Bradford, Daniel W; Strauss, Jennifer L; Capehart, Bruce P; Szabo, Steven T; Smith, Karen D; Dunn, Charlotte E; Conner, Kathryn M; Davidson, Jonathan R T; Wagner, Henry Ryan; Hamer, Robert M; Marx, Christine E

2015-05-01

Many individuals with post-traumatic stress disorder (PTSD) experience persistent symptoms despite pharmacological treatment with antidepressants. Several open-label monotherapy and adjunctive studies have suggested that aripiprazole (a second-generation antipsychotic) may have clinical utility in PTSD. However, there have been no randomized placebo-controlled trials of aripiprazole use for PTSD. We thus conducted a pilot randomized controlled trial of adjunctive aripiprazole versus placebo among Veterans with chronic PTSD serving in the US military since 11 September 2001 to assess the feasibility, safety, tolerability, and therapeutic potential of aripiprazole. Sixteen Veterans were randomized, and 14 completed at least 4 weeks of the study; 12 completed the entire 8-week trial. Outcome measures included the Clinician-Administered PTSD Scale (CAPS), PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores. Aripiprazole was well-tolerated in this cohort, and improvements in CAPS, PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores were as hypothesized. Although CAPS change scores did not reach statistical significance, aripiprazole outperformed placebo by 9 points on the CAPS in the last observation carried forward analysis compared with the placebo group (n = 7 per group), and by 20 points in the group randomized to aripiprazole that completed the entire study (n = 5) compared with the placebo group (n = 7). Results suggest promise for aripiprazole as an adjunctive strategy for the treatment of PTSD.

Associations of Adiposity and Aerobic Fitness with Executive Function and Math Performance in Danish Adolescents.

PubMed

Huang, Tao; Tarp, Jakob; Domazet, Sidsel Louise; Thorsen, Anne Kær; Froberg, Karsten; Andersen, Lars Bo; Bugge, Anna

2015-10-01

To examine the associations of adiposity and aerobic fitness with executive function and math performance in Danish adolescents. Cross-sectional analyses were conducted with data on 525 adolescents attending sixth and seventh grades from 14 schools in the 5 main regions of Denmark. A modified Eriksen flanker task was used to assess inhibitory control, a key aspect of executive function. Academic performance was assessed by a customized math test. Aerobic fitness was assessed by an intermittent shuttle-run test (Andersen test). Body mass index (BMI) was negatively associated with accuracy on incongruent trials during the flanker task (P = .005). A higher BMI was associated with a larger accuracy interference score (P = .01). Similarly, waist circumference (WC) was negatively associated with accuracy on incongruent trials (P = .008). A higher WC was associated with a larger reaction time (RT) interference score (P = .02) and accuracy interference score (P = .009). Higher aerobic fitness was associated with a faster RT on congruent trials (P = .009) and incongruent trials (P = .003). Higher aerobic fitness was associated with a smaller RT interference score (P = .04). Aerobic fitness was positively associated with math score (P < .001). BMI and WC were not associated with math score (P > .05). These results suggest that aerobic fitness is positively associated with both inhibitory control and math performance in adolescents. Adiposity is negatively associated with inhibitory control in adolescents. Adiposity is not associated with math performance. Copyright © 2015 Elsevier Inc. All rights reserved.

A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

PubMed

Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

2018-04-13

To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

Isoniazid for preventing tuberculosis in HIV-infected children

PubMed Central

Zunza, Moleen; Gray, Diane M; Young, Taryn; Cotton, Mark; Zar, Heather J

2017-01-01

Background Tuberculosis (TB) is an important cause of illness and death in HIV-positive children living in areas of high TB prevalence. We know that isoniazid prophylaxis prevents TB in HIV-negative children following TB exposure, but there is uncertainty related to its role in TB preventive treatment in HIV-positive children. Objectives To summarise the effects of TB preventive treatment versus placebo in HIV-positive children with no known TB contact on active TB, death, and reported adverse events. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE/PubMed, Embase and two trial registers up to February 2017. Selection criteria We included trials of HIV-positive children with and without known TB exposure, randomized to receive TB preventive treatment or placebo. Data collection and analysis Two review authors independently used the study selection criteria, assessed risk of bias, and extracted data. We assessed effects using risk, incidence rate and hazard ratios and assessed the certainty of evidence using GRADE. Main results We included three trials, involving 991 participants, below the age of 13 years, from South Africa and Botswana. Children were randomized to isoniazid prophylaxis or placebo, given daily or three times weekly. The median length of follow-up ranged from 5.7 to 34 months; some were on antiretroviral therapy (ART). In HIV-positive children not on ART, isoniazid prophylaxis may reduce the risk of active TB (hazard ratio (HR) 0.31, 95% confidence interval (CI) 0.11 to 0.87; 1 trial, 240 participants, low certainty evidence), and death (HR 0.46, 95% CI 0.22 to 0.95; 1 trial, 240 participants, low certainty evidence). One trial (182 participants) reported number of children with laboratory adverse events, which was similar between the isoniazid prophylaxis and placebo groups. No clinical adverse events were reported. In HIV-positive children on ART, we do not know if isoniazid prophylaxis reduces the risk of active TB (risk ratio (RR) 0.76, 95% CI 0.50 to 1.14; 3 trials, 737 participants, very low certainty evidence) or death (RR 1.45, 95% CI 0.78 to 2.72; 3 trials, 737 participants, very low certainty evidence). Two trials (714 participants) reported number of clinical adverse events and three trials (795 participants) reported number of laboratory adverse events; for both categories, the number of adverse events were similar between the isoniazid prophylaxis and placebo groups. Authors' conclusions Isoniazid prophylaxis given to all children diagnosed with HIV may reduce the risk of active TB and death in HIV-positive children not on ART in studies from Africa. For children on ART, no clear benefit was detected. . Isoniazid prophylaxis for preventing active tuberculosis and death in HIV-positive children What was the aim of this review? To summarise the effects of isoniazid prophylaxis on TB, death, and adverse effects in HIV-positive children. Key messages In areas of high tuberculosis endemicity, isoniazid prophylaxis prevents active TB and death in HIV-positive children who are not on ART. We conducted a review to assess the effect of TB medication on active TB or death and its safety in HIV-positive children. What was studied in the review? TB is a common cause of severe lung disease and death in HIV-positive children. Childhood TB is common in poor countries, especially those with a coexisting burden of HIV/AIDS disease. HIV-positive children have a higher risk of developing TB than HIV-negative children. Isoniazid prevents TB in HIV-positive adults and is currently used in children who are at high risk of developing TB disease after exposure to someone with TB. However, there is limited information on the effect of isoniazid medication in reducing active TB or death if given to HIV-positive children without known TB contact. We searched for studies up to 17 February 2017, and found three studies published between 2007 and 2014 that addressed the effect of isoniazid medication compared to no medication on active TB and death in 991 HIV-positive children, below the age of 13 years. Most of the children were on antiretroviral therapy (ART) and the studies were conducted in South Africa and Botswana. The median length of follow-up ranged from 5.7 to 34 months. What are the main results of the review? In HIV-positive children not taking ART, isoniazid medication reduced the number of children developing active TB by 69% (low certainty evidence), and death by 54% (low certainty evidence). One trial was conducted in HIV-positive children taking ART, and this did not detect any benefit or harm of isoniazid (very low certainty evidence). The number of children with adverse effects were similar in children receiving isoniazid medication as the control group in both children on ART and not on ART. How up to date is the review? The review authors searched for studies published up to February 2017. PMID:28850172

'Complementary ENT': a systematic review of commonly used supplements.

PubMed

Karkos, P D; Leong, S C; Arya, A K; Papouliakos, S M; Apostolidou, M T; Issing, W J

2007-08-01

To assess the evidence surrounding the use of certain complementary supplements in otolaryngology. We specifically focussed on four commonly used supplements: spirulina, Ginkgo biloba, Vertigoheel and nutritional supplements (cod liver oil, multivitamins and pineapple enzyme). A systematic review of the English and foreign language literature. in vivo human studies. animal trials, in vitro studies and case reports. We also excluded other forms of 'alternative medicine' such as reflexology, acupuncture and other homeopathic remedies. Lack of common outcome measures prevented a formal meta-analysis. Three studies on the effects of spirulina in allergy, rhinitis and immunomodulation were found. One was a double-blind, placebo, randomised, controlled trial (RCT) of patients with allergic rhinitis, demonstrating positive effects in patients fed spirulina for 12 weeks. The other two studies, although non-randomised, also reported a positive role for spirulina in mucosal immunity. Regarding the use of Ginkgo biloba in tinnitus, a Cochrane review published in 2004 showed no evidence for this. The one double-blind, placebo-controlled trial that followed confirmed this finding. Regarding the use of Vertigoheel in vertigo, two double-blind RCTs and a meta-analysis were identified. The first RCT suggested that Vertigoheel was equally effective in reducing the severity, duration and frequency of vertigo compared with betahistine. The second RCT suggested that Vertigoheel was a suitable alternative to G. biloba in the treatment of atherosclerosis-related vertigo. A meta-analysis of only four clinical trials confirms that Vertigoheel was equally effective compared with betahistine, G. biloba and dimenhydrinate. Regarding multivitamins and sinusitis, two small paediatric pilot studies reported a positive response for chronic sinusitis and otitis media following a course of multivitamins and cod liver oil. Regarding bromelain (pineapple enzyme) and sinusitis, one randomised, multicentre trial including 116 children compared bromelain monotherapy to bromelain with standard therapy and standard therapy alone, for the treatment of acute sinusitis. The bromelain monotherapy group showed a faster recovery compared with the other groups. The positive effects of spirulina in allergic rhinitis and of Vertigoheel in vertigo are based on good levels of evidence, but larger trials are required. There is overwhelming evidence that G. biloba may play no role in tinnitus. There is limited evidence for the use of multivitamins in sinus symptoms, and larger randomised trials are required.

Does Playworks Work? Findings from a Randomized Controlled Trial

ERIC Educational Resources Information Center

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

2013-01-01

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

Proactive Control: Neural Oscillatory Correlates of Conflict Anticipation and Response Slowing

PubMed Central

Ide, Jaime S.

2017-01-01

Abstract Proactive control allows us to anticipate environmental changes and adjust behavioral strategy. In the laboratory, investigators have used a number of different behavioral paradigms, including the stop-signal task (SST), to examine the neural processes of proactive control. Previous functional MRI studies of the SST have demonstrated regional responses to conflict anticipation—the likelihood of a stop signal or P(stop) as estimated by a Bayesian model—and reaction time (RT) slowing and how these responses are interrelated. Here, in an electrophysiological study, we investigated the time–frequency domain substrates of proactive control. The results showed that conflict anticipation as indexed by P(stop) was positively correlated with the power in low-theta band (3–5 Hz) in the fixation (trial onset)-locked interval, and go-RT was negatively correlated with the power in delta-theta band (2–8 Hz) in the go-locked interval. Stimulus prediction error was positively correlated with the power in the low-beta band (12–22 Hz) in the stop-locked interval. Further, the power of the P(stop) and go-RT clusters was negatively correlated, providing a mechanism relating conflict anticipation to RT slowing in the SST. Source reconstruction with beamformer localized these time–frequency activities close to brain regions as revealed by functional MRI in earlier work. These are the novel results to show oscillatory electrophysiological substrates in support of trial-by-trial behavioral adjustment for proactive control. PMID:28560315

Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

PubMed

Yang, Chiu-Ling; Chen, Chung-Hey

2018-01-01

Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

Understanding health economic analysis in critical care: insights from recent randomized controlled trials.

PubMed

Sud, Sachin; Cuthbertson, Brian H

2011-10-01

The article reviews the methods of health economic analysis (HEA) in clinical trials of critically ill patients. Emphasis is placed on the usefulness of HEA in the context of positive and 'no effect' studies, with recent examples. The need to control costs and promote effective spending in caring for the critically ill has garnered considerable attention due to the high cost of critical illness. Many clinical trials focus on short-term mortality, ignoring costs and quality of life, and fail to change clinical practice or promote efficient use of resources. Incorporating HEA into clinical trials is a possible solution. Such studies have shown some interventions, although expensive, provide good value, whereas others should be withdrawn from clinical practice. Incorporating HEA into randomized controlled trials (RCTs) requires careful attention to collect all relevant costs. Decision trees, modeling assumptions and methods for collecting costs and measuring outcomes should be planned and published beforehand to minimize bias. Costs and cost-effectiveness are potentially useful outcomes in RCTs of critically ill patients. Future RCTs should incorporate parallel HEA to provide both economic outcomes, which are important to the community, alongside patient-centered outcomes, which are important to individuals.

Knee osteoarthritis and role for surgical intervention: lessons learned from randomized clinical trials and population-based cohorts.

PubMed

Buchbinder, Rachelle; Richards, Bethan; Harris, Ian

2014-03-01

Over the last decade, there has been increased recognition of the importance of high-quality randomized controlled trials in determining the role of surgery for knee osteoarthritis. This review highlights key findings from the best available studies, and considers whether or not this knowledge has resulted in better evidence-based care. Use of arthroscopy to treat knee osteoarthritis has not declined despite strong evidence-based recommendations that do not sanction its use. A large randomized controlled trial has demonstrated that arthroscopic partial meniscectomy followed by a standardized physical therapy program results in similar improvements in pain and function at 6 and 12 months in comparison to physical therapy alone in patients with knee osteoarthritis and a symptomatic meniscal tear, confirming the findings of two previous trials. Two recent randomized controlled trials have demonstrated that decision aids help people to reach better-informed decisions about total knee arthroplasty. A majority of studies have indicated that for people with obesity the positive results of total knee arthroplasty may be compromised by postoperative complications, particularly infection. More efforts are needed to overcome significant evidence-practice gaps in the surgical management of knee osteoarthritis, particularly arthroscopy. Decision aids are a promising tool.

A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

PubMed Central

Fitzpatrick, Bridie; Watson, Nicholas; Cotmore, Richard; Wilson, Philip; Donaldson, Julia; Boyd, Kathleen; Zeanah, Charles; Norrie, John; Messow, Martina; Turner, Fiona; Irving, Susan

2013-01-01

Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home) is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child's neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510). PMID:24023537

Task difficulty modulates brain-behavior correlations in language production and cognitive control: Behavioral and fMRI evidence from a phonological go/no-go picture-naming paradigm.

PubMed

Zhang, Haoyun; Eppes, Anna; Beatty-Martínez, Anne; Navarro-Torres, Christian; Diaz, Michele T

2018-06-19

Language production and cognitive control are complex processes that involve distinct yet interacting brain networks. However, the extent to which these processes interact and their neural bases have not been thoroughly examined. Here, we investigated the neural and behavioral bases of language production and cognitive control via a phonological go/no-go picture-naming task. Naming difficulty and cognitive control demands (i.e., conflict monitoring and response inhibition) were manipulated by varying the proportion of naming trials (go trials) and inhibition trials (no-go trials) across task runs. The results demonstrated that as task demands increased, participants' behavioral performance declined (i.e., longer reaction times on naming trials, more commission errors on inhibition trials) whereas brain activation generally increased. Increased activation was found not only within the language network but also in domain-general control regions. Additionally, right superior and inferior frontal and left supramarginal gyri were sensitive to increased task difficulty during both language production and response inhibition. We also found both positive and negative brain-behavior correlations. Most notably, increased activation in sensorimotor regions, such as precentral and postcentral gyri, was associated with better behavioral performance, in both successful picture naming and successful inhibition. Moreover, comparing the strength of correlations across conditions indicated that the brain-behavior correlations in sensorimotor regions that were associated with improved performance became stronger as task demands increased. Overall, our results suggest that cognitive control demands affect language production, and that successfully coping with increases in task difficulty relies on both language-specific and domain-general cognitive control regions.

Sonographic evaluation of the fetal spine position and success rate of manual rotation of the fetus in occiput posterior position: A randomized controlled trial.

PubMed

Masturzo, Bianca; Farina, Antonio; Attamante, Lorenza; Piazzese, Annalisa; Rolfo, Alessandro; Gaglioti, Pietro; Todros, Tullia

2017-10-01

To evaluate whether sonographic (US) diagnosis of the fetal spine position could increase the success rate of manual rotation of the fetal occiput (MRFO) in second-stage arrest in persistent occiput posterior position (OPP). In this randomized controlled parallel single-center trial, 58 nulliparous in second-stage arrest of labor with fetus in cephalic presentation and OPP diagnosed by US were randomly assigned to group A where the fetal spine position was not known by the operator or to group B where the operator knew it. The main outcome was the success of MRFO in the two groups. Secondary outcomes were perineal injuries, blood loss, duration of expulsive period, and neonatal APGAR at 5 minutes. A priori knowledge of the spine position improves the success of the MRFO (41.4% group A versus 82.8% group B, p value < 0.001), the percentage of spontaneous deliveries (27.6% group A versus 69% group B, p value = 0.01), and maternal outcome (intact perineum and blood loss). No differences were detected on the neonatal side. MRFO is a safe and useful procedure that should be performed in second-stage arrest in OPP. A better performance was observed when supported by the US knowledge of the spine position. © 2017 Wiley Periodicals, Inc. J Clin Ultrasound 45:472-476, 2017. © 2017 Wiley Periodicals, Inc.

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

Efficacy of group psychotherapy for social anxiety disorder: A meta-analysis of randomized-controlled trials.

PubMed

Barkowski, Sarah; Schwartze, Dominique; Strauss, Bernhard; Burlingame, Gary M; Barth, Jürgen; Rosendahl, Jenny

2016-04-01

Group psychotherapy for social anxiety disorder (SAD) is an established treatment supported by findings from primary studies and earlier meta-analyses. However, a comprehensive summary of the recent evidence is still pending. This meta-analysis investigates the efficacy of group psychotherapy for adult patients with SAD. A literature search identified 36 randomized-controlled trials examining 2171 patients. Available studies used mainly cognitive-behavioral group therapies (CBGT); therefore, quantitative analyses were done for CBGT. Medium to large positive effects emerged for wait list-controlled trials for specific symptomatology: g=0.84, 95% CI [0.72; 0.97] and general psychopathology: g=0.62, 95% CI [0.36; 0.89]. Group psychotherapy was also superior to common factor control conditions in alleviating symptoms of SAD, but not in improving general psychopathology. No differences appeared for direct comparisons of group psychotherapy and individual psychotherapy or pharmacotherapy. Hence, group psychotherapy for SAD is an efficacious treatment, equivalent to other treatment formats. Copyright © 2016 Elsevier Ltd. All rights reserved.

Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial

PubMed Central

2012-01-01

Background While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. Methods Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16), three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers) was employed to ensure methodological rigour. Participant’s experiences were categorised as “positive” or “negative” and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender). Usual experiences were categorised and discussed separately. Results Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022) and enhanced mood (p=.027). The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin group having minor digestive complaints. Conclusion This represents the first documented qualitative investigation of participants’ experience of chronic administration of a multivitamin. Results uncovered a range of subjective beneficial effects that are consistent with quantitative data from previously published randomised controlled trials examining the effects of multivitamins and B vitamin complexes on mood and well-being. Trial registration Prior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au) ACTRN12611000092998 PMID:23241329

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease.

PubMed

Niesink, A; Trappenburg, J C A; de Weert-van Oene, G H; Lammers, J W J; Verheij, T J M; Schrijvers, A J P

2007-11-01

Chronic disease management for patients with chronic obstructive pulmonary disease (COPD) may improve quality, outcomes and access to care. To investigate effectiveness of chronic disease management programmes on the quality-of-life of people with COPD. Medline and Embase (1995-2005) were searched for relevant articles, and reference lists and abstracts were searched for controlled trials of chronic disease management programmes for patients with COPD. Quality-of-life was assessed as an outcome parameter. Two reviewers independently reviewed each paper for methodological quality and extracted the data. We found 10 randomized-controlled trials comparing chronic disease management with routine care. Patient populations, health-care professionals, intensity, and content of the intervention were heterogeneous. Different instruments were used to assess quality of life. Five out of 10 studies showed statistically significant positive outcomes on one or more domains of the quality of life instruments. Three studies, partly located in primary care, showed positive results. All chronic disease management projects for people with COPD involving primary care improved quality of life. In most of the studies, aspects of chronic disease management were applied to a limited extent. Quality of randomized-controlled trials was not optimal. More research is needed on chronic disease management programmes in patients with COPD across primary and secondary care.

Semi-recumbent position versus supine position for the prevention of ventilator-associated pneumonia in adults requiring mechanical ventilation.

PubMed

Wang, Li; Li, Xiao; Yang, Zongxia; Tang, Xueli; Yuan, Qiang; Deng, Lijing; Sun, Xin

2016-01-08

Ventilator-associated pneumonia (VAP) is associated with increased mortality, prolonged length of hospital stay and increased healthcare costs in critically ill patients. Guidelines recommend a semi-recumbent position (30º to 45º) for preventing VAP among patients requiring mechanical ventilation. However, due to methodological limitations in existing systematic reviews, uncertainty remains regarding the benefits and harms of the semi-recumbent position for preventing VAP. To assess the effectiveness and safety of semi-recumbent positioning versus supine positioning to prevent ventilator-associated pneumonia (VAP) in adults requiring mechanical ventilation. We searched CENTRAL (2015, Issue 10), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1946 to October 2015), EMBASE (2010 to October 2015), CINAHL (1981 to October 2015) and the Chinese Biomedical Literature Database (CBM) (1978 to October 2015). We included randomised controlled trials (RCTs) comparing semi-recumbent versus supine positioning (0º to 10º), or RCTs comparing alternative degrees of positioning in mechanically ventilated patients. Our outcomes included clinically suspected VAP, microbiologically confirmed VAP, intensive care unit (ICU) mortality, hospital mortality, length of ICU stay, length of hospital stay, duration of ventilation, antibiotic use and any adverse events. Two review authors independently and in duplicate screened titles, abstracts and full texts, assessed risk of bias and extracted data using standardised forms. We calculated the mean difference (MD) and 95% confidence interval (95% CI) for continuous data and the risk ratio (RR) and 95% CI for binary data. We performed meta-analysis using the random-effects model. We used the grading of recommendations, assessment, development and evaluation (GRADE) approach to grade the quality of evidence. We included 10 trials involving 878 participants, among which 28 participants in two trials did not provide complete data due to loss to follow-up. We judged all trials to be at high risk of bias. Semi-recumbent position (30º to 60º) versus supine position (0° to 10°) A semi-recumbent position (30º to 60º) significantly reduced the risk of clinically suspected VAP compared to a 0º to 10º supine position (eight trials, 759 participants, 14.3% versus 40.2%, RR 0.36; 95% CI 0.25 to 0.50; risk difference (RD) 25.7%; 95% CI 20.1% to 30.1%; GRADE: moderate quality evidence).There was no significant difference between the two positions in the following outcomes: microbiologically confirmed VAP (three trials, 419 participants, 12.6% versus 31.6%, RR 0.44; 95% CI 0.11 to 1.77; GRADE: very low quality evidence), ICU mortality (two trials, 307 participants, 29.8% versus 34.3%, RR 0.87; 95% CI 0.59 to 1.27; GRADE: low quality evidence), hospital mortality (three trials, 346 participants, 23.8% versus 27.6%, RR 0.84; 95% CI 0.59 to 1.20; GRADE: low quality evidence), length of ICU stay (three trials, 346 participants, MD -1.64 days; 95% CI -4.41 to 1.14 days; GRADE moderate quality evidence), length of hospital stay (two trials, 260 participants, MD -9.47 days; 95% CI -34.21 to 15.27 days; GRADE: very low quality evidence), duration of ventilation (four trials, 458 participants, MD -3.35 days; 95% CI -7.80 to 1.09 days), antibiotic use (three trials, 284 participants, 84.8% versus 84.2%, RR 1.00; 95% CI 0.97 to 1.03) and pressure ulcers (one trial, 221 participants, 28% versus 30%, RR 0.91; 95% CI 0.60 to 1.38; GRADE: low quality evidence). No other adverse events were reported. Semi-recumbent position (45°) versus 25° to 30° We found no statistically significant differences in the following prespecified outcomes: clinically suspected VAP (two trials, 91 participants, RR 0.74; 95% CI 0.35 to 1.56; GRADE: very low quality evidence), microbiologically confirmed VAP (one trial, 30 participants, RR 0.61; 95% CI 0.20 to 1.84: GRADE: very low quality evidence), ICU mortality (one trial, 30 participants, RR 0.57; 95% CI 0.15 to 2.13; GRADE: very low quality evidence), hospital mortality (two trials, 91 participants, RR 1.00; 95% CI 0.38 to 2.65; GRADE: very low quality evidence), length of ICU stay (one trial, 30 participants, MD 1.6 days; 95% CI -0.88 to 4.08 days; GRADE: very low quality evidence) and antibiotic use (two trials, 91 participants, RR 1.11; 95% CI 0.84 to 1.47). No adverse events were reported. A semi-recumbent position (≧ 30º) may reduce clinically suspected VAP compared to a 0° to 10° supine position. However, the evidence is seriously limited with a high risk of bias. No adequate evidence is available to draw any definitive conclusion on other outcomes and the comparison of alternative semi-recumbent positions. Adverse events, particularly venous thromboembolism, were under-reported.

Evaluation of Tai Chi Yunshou exercises on community-based stroke patients with balance dysfunction: a study protocol of a cluster randomized controlled trial.

PubMed

Tao, Jing; Rao, Ting; Lin, Lili; Liu, Wei; Wu, Zhenkai; Zheng, Guohua; Su, Yusheng; Huang, Jia; Lin, Zhengkun; Wu, Jinsong; Fang, Yunhua; Chen, Lidian

2015-02-25

Balance dysfunction after stroke limits patients' general function and participation in daily life. Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals' balance function and reduce the risk of falls. But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate. Considering the difficulties for stroke patients to complete the whole exercise, the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization, parallel-controlled design. A single-blind, cluster-randomized, parallel-controlled trial will be conducted. A total of 10 community health centers (5 per arm) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group. Each community health centers will be asked to enroll 25 eligible patients into the trial. 60 minutes per each session, 1 session per day, 5 times per week and the total training round is 12 weeks. Primary and secondary outcomes will be measured at baseline and 4-weeks, 8-weeks, 12-weeks, 6-week follow-up, 12-week follow-up after randomization. Safety and economic evaluation will also be assessed. This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke. If the outcome is positive, this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients. Chinese Clinical Trial Registry: ChiCTR-TRC-13003641. Registration date: 22 August, 2013 http://www.chictr.org/usercenter/project/listbycreater.aspx .

Efficacy vs effectiveness trial results of an indicated "model" substance abuse program: implications for public health.

PubMed

Hallfors, Denise; Cho, Hyunsan; Sanchez, Victoria; Khatapoush, Shereen; Kim, Hyung Min; Bauer, Daniel

2006-12-01

The US Department of Education requires schools to choose substance abuse and violence prevention programs that meet standards of effectiveness. The Substance Abuse and Mental Health Services Agency certifies "model" programs that meet this standard. We compared findings from a large, multisite effectiveness trial of 1 model program to its efficacy trial findings, upon which the certification was based. 1370 high-risk youths were randomized to experimental or control groups across 9 high schools in 2 large urban school districts. We used intent-to-treat and on-treatment approaches to examine baseline equivalence, attrition, and group differences in outcomes at the end of the program and at a 6-month follow-up. Positive efficacy trial findings were not replicated in the effectiveness trial. All main effects were either null or worse for the experimental than for the control group. These findings suggest that small efficacy trials conducted by developers provide insufficient evidence of effectiveness. Federal agencies and public health scientists must work together to raise the standards of evidence and ensure that data from new trials are incorporated into ongoing assessments of program effects.

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.

Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial.

PubMed

Kacmarek, Robert M; Villar, Jesús; Sulemanji, Demet; Montiel, Raquel; Ferrando, Carlos; Blanco, Jesús; Koh, Younsuck; Soler, Juan Alfonso; Martínez, Domingo; Hernández, Marianela; Tucci, Mauro; Borges, Joao Batista; Lubillo, Santiago; Santos, Arnoldo; Araujo, Juan B; Amato, Marcelo B P; Suárez-Sipmann, Fernando

2016-01-01

The open lung approach is a mechanical ventilation strategy involving lung recruitment and a decremental positive end-expiratory pressure trial. We compared the Acute Respiratory Distress Syndrome network protocol using low levels of positive end-expiratory pressure with open lung approach resulting in moderate to high levels of positive end-expiratory pressure for the management of established moderate/severe acute respiratory distress syndrome. A prospective, multicenter, pilot, randomized controlled trial. A network of 20 multidisciplinary ICUs. Patients meeting the American-European Consensus Conference definition for acute respiratory distress syndrome were considered for the study. At 12-36 hours after acute respiratory distress syndrome onset, patients were assessed under standardized ventilator settings (FIO2≥0.5, positive end-expiratory pressure ≥10 cm H2O). If Pao2/FIO2 ratio remained less than or equal to 200 mm Hg, patients were randomized to open lung approach or Acute Respiratory Distress Syndrome network protocol. All patients were ventilated with a tidal volume of 4 to 8 ml/kg predicted body weight. From 1,874 screened patients with acute respiratory distress syndrome, 200 were randomized: 99 to open lung approach and 101 to Acute Respiratory Distress Syndrome network protocol. Main outcome measures were 60-day and ICU mortalities, and ventilator-free days. Mortality at day-60 (29% open lung approach vs. 33% Acute Respiratory Distress Syndrome Network protocol, p = 0.18, log rank test), ICU mortality (25% open lung approach vs. 30% Acute Respiratory Distress Syndrome network protocol, p = 0.53 Fisher's exact test), and ventilator-free days (8 [0-20] open lung approach vs. 7 [0-20] d Acute Respiratory Distress Syndrome network protocol, p = 0.53 Wilcoxon rank test) were not significantly different. Airway driving pressure (plateau pressure - positive end-expiratory pressure) and PaO2/FIO2 improved significantly at 24, 48 and 72 hours in patients in open lung approach compared with patients in Acute Respiratory Distress Syndrome network protocol. Barotrauma rate was similar in both groups. In patients with established acute respiratory distress syndrome, open lung approach improved oxygenation and driving pressure, without detrimental effects on mortality, ventilator-free days, or barotrauma. This pilot study supports the need for a large, multicenter trial using recruitment maneuvers and a decremental positive end-expiratory pressure trial in persistent acute respiratory distress syndrome.

Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial -- the HPV FOCAL Study.

PubMed

Ogilvie, G S; Krajden, M; van Niekerk, D J; Martin, R E; Ehlen, T G; Ceballos, K; Smith, L W; Kan, L; Cook, D A; Peacock, S; Stuart, G C E; Franco, E L; Coldman, A J

2012-12-04

Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented. The three arms are: Control arm - liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm - hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm - hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years. A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+. After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm.

Chemoprophylaxis in Contacts of Patients with Cholera: Systematic Review and Meta-Analysis

PubMed Central

Reveiz, Ludovic; Chapman, Evelina; Ramon-Pardo, Pilar; Koehlmoos, Tracey Perez; Cuervo, Luis Gabriel; Aldighieri, Sylvain; Chambliss, Amy

2011-01-01

Introduction There is a pressing need for effective measures to prevent the spread of cholera. Our systematic review assesses the effects of chemoprophylaxis in preventing cholera among exposed contacts. Methods and Findings We considered published and unpublished reports of studies up to July 2011. For this we searched: PubMed (1966 to July, 2011), Embase (1980 to July 2011), Cochrane Central Register of Controlled Trials (6; 2011), LILACS (1982 to July, 2011), the International Clinical Trials Registry Platform (July 2011) and references of identified publications. We included controlled clinical trials (randomized and non-randomized) in which chemoprophylaxis was used to prevent cholera among patient contacts. The main outcome measures were hospitalization and laboratory diagnosis of cholera in contacts for cholera patients. We assessed the risk of bias. We identified 2638 references and these included 2 randomized trials and 5 controlled trials that added up to a total of 4,154 participants. The risk of bias scored high for most trials. The combined results from two trials found that chemoprophylaxis reduced hospitalization of contacts during the follow-up period by 8–12 days (2826 participants; RR 0.54 95% CI 0.40–0.74;I2 0%). A meta-analysis of five trials found a significant reduction in disease among contacts with at least one positive sample who received chemoprophylaxis during the overall follow-up (range 4–15 days) (1,414 participants; RR 0.35 95% CI 0.18–0.66;I2 74%). A significant reduction in the number of positive samples was also found with chemoprophylaxis (3 CCT; 6,918 samples; RR 0.39 95% CI 0.29–0.51;I2 0%). Conclusion Our findings suggest that chemoprophylaxis has a protective effect among household contacts of people with cholera but the results are based on studies with a high risk of bias. Hence, there is a need for adequate reliable research that allows balancing benefits and harms by evaluating the effects of chemoprophylaxis. PMID:22102873

Just-in-time information improved decision-making in primary care: a randomized controlled trial.

PubMed

McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

2008-01-01

The "Just-in-time Information" (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. In this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action. Controlled-Trials.com ISRCTN96823810.

Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial.

PubMed

Adams, Sally; Penton-Voak, Ian S; Harmer, Catherine J; Holmes, Emily A; Munafò, Marcus R

2013-06-01

We have developed a new paradigm that targets the recognition of facial expression of emotions. Here we report the protocol of a randomised controlled trial of the effects of emotion recognition training on mood in a sample of individuals with depressive symptoms over a 6-week follow-up period. We will recruit 190 adults from the general population who report high levels of depressive symptoms (defined as a score ≥ 14 on the Beck Depression Inventory-II). Participants will attend a screening session and will be randomised to intervention or control procedures, repeated five times over consecutive days (Monday to Friday). A follow-up session will take place at end-of -treatment, 2-weeks and 6-weeks after training. Our primary study outcome will be depressive symptoms, Beck Depression Inventory- II (rated over the past two weeks). Our secondary outcomes are: depressive symptoms, Hamilton Rating Scale for Depression; anxiety symptoms, Beck Anxiety Inventory (rated over the past month); positive affect, Positive and Negative Affect Schedule (rated as 'how you feel right now'); negative affect, Positive and Negative Affect Schedule (rated as 'how you feel right now'); emotion sensitivity, Emotion Recognition Task (test phase); approach motivation and persistence, the Fishing Game; and depressive interpretation bias, Scrambled Sentences Test. This study is of a novel cognitive bias modification technique that targets biases in emotional processing characteristic of depression, and can be delivered automatically via computer, Internet or Smartphone. It therefore has potential to be a valuable cost-effective adjunctive treatment for depression which may be used together with more traditional psychotherapy, cognitive-behavioural therapy and pharmacotherapy. Current Controlled Trials: ISRCTN17767674.

Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial.

PubMed

Victor, Jan; Dujardin, Jan; Vandenneucker, Hilde; Arnout, Nele; Bellemans, Johan

2014-01-01

Recently, patient-specific guides (PSGs) have been introduced, claiming a significant improvement in accuracy and reproducibility of component positioning in TKA. Despite intensive marketing by the manufacturers, this claim has not yet been confirmed in a controlled prospective trial. We (1) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and (2) logged the need for applying changes in the suggested position of the PSG. In this randomized controlled trial, we enrolled 128 patients. In the PSG cohort, surgical navigation was used as an intraoperative control. When the suggested cut deviated more than 3° from target, the use of PSG was abandoned and marked as an outlier. When cranial-caudal position or size was adapted, the PSG was marked as modified. All patients underwent long-leg standing radiography and CT scan. Deviation of more than 3° from the target in any plane was defined as an outlier. The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment (25% versus 28%; p = 0.69), femoral coronal alignment (7% versus 14%) (p = 0.24), and femoral axial alignment (23% versus 17%; p = 0.50). There were more outliers in tibial coronal (15% versus 3%; p = 0.03) and sagittal 21% versus 3%; p = 0.002) alignment in the PSG group than in the conventional group. PSGs were abandoned in 14 patients (22%) and modified in 18 (28%). PSGs do not improve accuracy in TKA and, in our experience, were somewhat impractical in that the procedure needed to be either modified or abandoned with some frequency.

Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

PubMed

Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

2016-01-01

Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

Effects of positive psychology interventions on risk biomarkers in coronary patients: A randomized, wait-list controlled pilot trial

PubMed Central

Nikrahan, Gholam Reza; Laferton, Johannes A. C.; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C.

2016-01-01

Background Among cardiac patients, positive psychological factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychological well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of three distinct PPIs on risk biomarkers in cardiac patients. Methods In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to a) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or b) a wait-list control group. Risk biomarkers were assessed at baseline, post-intervention (7 weeks), and at 15 week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Results Compared to the control group, participants randomized to the Seligman (B= −2.06; p= .02) and Fordyce PPI (B= −1.54; p= .04) had significantly lower high-sensitivity C-reactive protein (hs-CRP) levels at 7 weeks. Further, the Lyubomirsky PPI (B= −245.86; p= .04) was associated with a significantly lower cortisol awakening response (CARg) at 7 weeks compared to control participants. There were no other significant between-group differences. Conclusion Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. PMID:27129358

Executive Functioning in Alcoholics Following an mHealth Cognitive Stimulation Program: Randomized Controlled Trial

PubMed Central

Oliveira, Jorge; Lopes, Paulo; Brito, Rodrigo; Morais, Diogo; Silva, Diana; Silva, Ana; Rebelo, Sara; Bastos, Marta; Deus, Alberto

2014-01-01

Background The consequences of alcohol dependence are severe and may range from physical disease to neuropsychological deficits in several cognitive domains. Alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex. Conventional neuropsychological interventions (paper-and-pencil cognitive stimulation training) have a positive effect but are time-consuming, costly, and not motivating for patients. Objective Our goal was to test the cognitive effects of a novel approach to neuropsychological intervention, using mobile technology and serious games, on patients with alcohol dependence. Methods The trial design consisted of a two-arm study assessing the cognitive outcomes of neuropsychological intervention with mobile serious games (mHealth) versus control (treatment-as-usual with no neuropsychological intervention) in patients undergoing treatment for alcohol dependence syndrome. Sixty-eight patients were recruited from an alcohol-rehab clinic and randomly assigned to the mHealth (n=33) or control condition (n=35). The intervention on the experimental group consisted of a therapist-assisted cognitive stimulation therapy for 4 weeks on a 2-3 days/week basis. Results Fourteen patients dropped out of the study. The results of the neuropsychological assessments with the remaining 54 patients showed an overall increase (P<.05) of general cognitive abilities, mental flexibility, psychomotor processing speed, and attentional ability in both experimental (n=26) and control groups (n=28). However, there was a more pronounced improvement (P=.01) specifically in frontal lobe functions from baseline (mean 13.89, SE 0.58) to follow-up (mean 15.50, SE 0.46) in the experimental group but not in the control group. Conclusions The overall increase in general cognitive function for both experimental and control groups supports the beneficial role of existing alcohol treatment protocols aimed at minimizing withdrawal symptoms, but the differential improvements observed in frontal lobe functioning supports the use of mobile serious games for neuropsychological stimulation to overcome executive dysfunction in patients with alcohol dependence. This trial was negative on two neuropsychological/cognitive tests, and positive on one. Trial Registration ClinicalTrials.gov NCT01942954; http://www.clinicaltrials.gov/ct2/show/NCT01942954 (Archived by WebCite at http://www.webcitation.org/6OYDqHLwB). PMID:24742381

Effects of local treatment with and without sensorimotor and balance exercise in individuals with neck pain: protocol for a randomized controlled trial.

PubMed

Sremakaew, Munlika; Jull, Gwendolen; Treleaven, Julia; Barbero, Marco; Falla, Deborah; Uthaikhup, Sureeporn

2018-02-13

Impaired cervical joint position sense and balance are associated with neck pain. Specific therapeutic exercise and manual therapy are effective for improving neck pain and functional ability but their effects on joint position sense and balance impairments remain uncertain. Changes in the joint position sense and balance may need to be addressed specifically. The primary objective is to investigate the most effective interventions to improve impaired cervical joint position sense and balance in individuals with neck pain. The secondary objective is to assess the effectiveness of the interventions on pain intensity and disability, pain location, dizziness symptoms, cervical range of motion, gait speed, functional ability, treatment satisfaction and quality of life. A 2 × 2 factorial, single blind RCT with immediate, short- and long-term follow-ups. One hundred and sixty eight participants with neck pain with impaired joint position sense and balance will be recruited into the trial. Participants will be randomly allocated to one of four intervention groups: i) local neck treatment, ii) local treatment plus tailored sensorimotor exercises, iii) local treatment plus balance exercises, and iv) local treatment plus sensorimotor and balance exercises. Participants receive two treatments for 6 weeks. Primary outcomes are postural sway and cervical joint position error. Secondary outcomes include gait speed, dizziness intensity, neck pain intensity, neck disability, pain extent and location, cervical range of motion, functional ability, perceived benefit, and quality of life. Assessment will be measured at baseline, immediately after treatment and at 3, 6, 12 month-follow ups. Neck pain is one of the major causes of disability. Effective treatment must address not only the symptoms but the dysfunctions associated with neck pain. This trial will evaluate the effectiveness of interventions for individuals with neck pain with impaired cervical joint position sense and balance. This trial will impact on clinical practice by providing evidence towards optimal and efficient management. ClinicalTrials.gov ( NCT03149302 ). May 10, 2017.

Feasibility and Effectiveness of a Web-Based Positive Psychology Program for Youth Mental Health: Randomized Controlled Trial

PubMed Central

Horswood, Deserae; Burckhardt, Rowan; Lum, Alistair; Hadzi-Pavlovic, Dusan; Parker, Gordon

2014-01-01

Background Youth mental health is a significant public health concern due to the high prevalence of mental health problems in this population and the low rate of those affected seeking help. While it is increasingly recognized that prevention is better than cure, most youth prevention programs have utilized interventions based on clinical treatments (eg, cognitive behavioral therapy) with inconsistent results. Objective This study explores the feasibility of the online delivery of a youth positive psychology program, Bite Back, to improve the well-being and mental health outcomes of Australian youth. Further aims were to examine rates of adherence and attrition, and to investigate the program’s acceptability. Methods Participants (N=235) aged 12-18 years were randomly assigned to either of two conditions: Bite Back (n=120) or control websites (n=115). The Bite Back website comprised interactive exercises and information across a variety of positive psychology domains; the control condition was assigned to neutral entertainment-based websites that contained no psychology information. Participants in both groups were instructed to use their allocated website for 6 consecutive weeks. Participants were assessed pre- and postintervention on the Depression Anxiety Stress Scale-Short form (DASS-21) and the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). Results Of the 235 randomized participants, 154 (65.5%) completed baseline and post measures after 6 weeks. Completers and dropouts were equivalent in demographics, the SWEMWBS, and the depression and anxiety subscales of the DASS-21, but dropouts reported significantly higher levels of stress than completers. There were no differences between the Bite Back and control conditions at baseline on demographic variables, DASS-21, or SWEMWBS scores. Qualitative data indicated that 49 of 61 Bite Back users (79%) reported positive experiences using the website and 55 (89%) agreed they would continue to use it after study completion. Compared to the control condition, participants in the Bite Back condition with high levels of adherence (usage of the website for 30 minutes or more per week) reported significant decreases in depression and stress and improvements in well-being. Bite Back users who visited the site more frequently (≥3 times per week) reported significant decreases in depression and anxiety and improvements in well-being. No significant improvements were found among Bite Back users who demonstrated low levels of adherence or who used the website less frequently. Conclusions Results suggest that using an online positive psychology program can decrease symptoms of psychopathology and increase well-being in young people, especially for those who use the website for 30 minutes or longer per week or more frequently (≥3 times per week). Acceptability of the Bite Back website was high. These findings are encouraging and suggest that the online delivery of positive psychology programs may be an alternate way to address mental health issues and improve youth well-being nationally. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 (Archived by Webcite at http://www.webcitation.org/6NXmjwfAy). PMID:24901900

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

PubMed

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

2015-12-03

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

Treatment with L-citrulline in patients with post-polio syndrome: study protocol for a single-center, randomised, placebo-controlled, double-blind trial.

PubMed

Schmidt, Simone; Gocheva, Vanya; Zumbrunn, Thomas; Rubino-Nacht, Daniela; Bonati, Ulrike; Fischer, Dirk; Hafner, Patricia

2017-03-09

Post-polio syndrome (PPS) is a condition that affects polio survivors years after recovery from an initial acute infection by the Poliomyelitis virus. Most often, patients who suffered from polio start to experience gradual new weakening in muscles, a gradual decrease in the size of muscles (muscle atrophy) and fatigue years after the acute illness. L-citrulline is known to change muscular metabolism synthesis by raising nitric oxide (NO) levels and increasing protein synthesis. This investigator-initiated, randomised, placebo-controlled, double-blind, trial aims to demonstrate that L-citrulline positively influences muscle function and increases muscular energy production in patients with PPS. Thirty ambulant PPS patients will be recruited in Switzerland. Patients will be randomly allocated to one of the two arms of the study (placebo:verum 1:1). After a 24-week run-in phase to observe natural disease history and progression, participants will be treated either with L-citrulline or placebo for 24 weeks. The primary endpoint is change in the 6-min Walking Distance Test. Secondary endpoints will include motor function measure, quantitative muscle force, quantitative muscle magnetic resonance imaging and magnetic resonance spectroscopy and serum biomarker laboratory analysis DISCUSSION: The aim of this phase IIa trial is to determine if treatment with L-citrulline shows a positive effect on clinical function and paraclinical biomarkers in PPS. If treatment with L-citrulline shows positive effects, this might represent a cost-efficient symptomatic therapy for PPS patients. ClinicalTrial.gov, ID: NCT02801071 . Registered on 6 June 2016.

Research leadership and investigators: gender distribution in the federal government.

PubMed

McCarren, Madeline; Goldman, Steven

2012-08-01

The National Academies reported in Beyond Bias and Barriers: Fulfilling the Potential of Women in Academic Science and Engineering (2006) that "women are very likely to face discrimination." In academic medicine, gender distribution is becoming more balanced. In the federal government, women also have made progress, doubling their representation in professional positions to 44%. The Department of Veterans Affairs (VA) has a research program and a mission to train health care professionals; however, its gender distribution has not been described. We conducted a descriptive study using public data for positions in the VA, National Institutes of Health (NIH), and Agency for Healthcare Research and Quality (AHRQ). We followed with a case-control analysis of predictors of receipt of grant funding in the VA. Participants were 224 leadership positions and 132 principal investigators. Women comprised 33% (AHRQ), 27% (NIH), and 0% (VA) of the top research leadership. Across all VA research levels, women comprised 45% to 0%, depending on the service. In the case-control analysis of principal investigators, men had greater odds (odds ratio 8.0) of a Cooperative Studies Program (CSP) trial award. History of first, last, or any authorship on a clinical trial publication in the 10 years before the index trial was only weakly associated with award of a CSP trial. The gender imbalance was not explained by publication history. Marked gender disparities were seen in the VA, except in Health Services Research. Organizations must investigate their practices to reveal disparities, investigate underlying factors, and intervene as needed. Published by Elsevier Inc.

Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial.

PubMed

Tamarelle, Jeanne; Thiébaut, Anne C M; Sabin, Bénédicte; Bébéar, Cécile; Judlin, Philippe; Fauconnier, Arnaud; Rahib, Delphine; Méaude-Roufai, Layidé; Ravel, Jacques; Morré, Servaas A; de Barbeyrac, Bertille; Delarocque-Astagneau, Elisabeth

2017-11-13

Genital infection with Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection, especially among young women. Mostly asymptomatic, it can lead, if untreated, to pelvic inflammatory disease (PID), tubal factor infertility and ectopic pregnancy. Recent data suggest that Ct infections are not controlled in France and in Europe. The effectiveness of a systematic strategy for Ct screening in under-25 women remains controversial. The main objective of the i-Predict trial (Prevention of Diseases Induced by Chlamydia trachomatis) is to determine whether early screening and treatment of 18- to-24-year-old women for genital Ct infection reduces the incidence of PID over 24 months. This is a randomised prevention trial including 4000 eighteen- to twenty-four-year-old sexually active female students enrolled at five universities. The participants will provide a self-collected vaginal swab sample and fill in an electronic questionnaire at baseline and at 6, 12 and 18 months after recruitment. Vaginal swabs in the intervention arm will be analysed immediately for Ct positivity, and participants will be referred for treatment if they have a positive test result. Vaginal swabs from the control arm will be analysed at the end of the study. All visits to general practitioners, gynaecologists or gynaecology emergency departments for pelvic pain or other gynaecological symptoms will be recorded to evaluate the incidence of PID, and all participants will attend a final visit in a hospital gynaecology department. The primary endpoint measure will be the incidence of PID over 24 months. The outcome status (confirmed, probable or no PID) will be assessed by two independent experts blinded to group assignment and Ct status. This trial is expected to largely contribute to the development of recommendations for Ct screening in young women in France to prevent PID and related complications. It is part of a comprehensive approach to gathering data to facilitate decision-making regarding optimal strategies for Ct infection control. The control group of this randomised trial, following current recommendations, will allow better documentation of the natural history of Ct infection, a prerequisite to evaluating the impact of Ct screening. Characterisation of host immunogenetics will also allow identification of women at risk for complications. ClinicalTrials.gov, NCT02904811 . Registered on September 14, 2016. World Health Organisation International Clinical Trials Registry, NCT02904811. AOM, 15-0063 and P150950. Registered on September 26, 2016. A completed Standard Protocol Items : Recommendations for International Trials (SPIRIT) Checklist is available in additional file 1.

Does peer-assisted learning improve academic performance? A scoping review.

PubMed

Williams, Brett; Reddy, Priya

2016-07-01

Due to the diverse and ever-changing nature of the healthcare industry, teaching pedagogies such as peer-assisted learning (PAL) are being implemented to align with external competency standards. A scoping review was conducted in order to map the breadth of literature available on PAL and its impact on student performance. This review used Arksey and O'Malley's six stage scoping methodology. The databases searched included: Cinahl, Ovid Medline, Proquest and Embase as well as grey literature sites and dissertations. 22 articles were included in this review, 10 of which were mixed methods randomised controlled trials, one retrospective study, four controlled trials, two randomised cross over controlled trial, three prospective randomised controlled trials, one thesis and one comparative research design. Analysis of the included articles identified three major themes outlining student performance. Student teachers themselves showed the most significant improvement in objective outcomes. The predominant healthcare field addressed were medical students with very few studies being completed on other professions. The search indicated an overall positive response to PAL with the measurable outcome of student tutors being of most significance. Further research is required to determine the relevance for the wider healthcare community. Copyright © 2016 Elsevier Ltd. All rights reserved.

A randomized controlled trial of an intervention program to Brazilian mothers who use corporal punishment.

PubMed

Santini, Paolla Magioni; Williams, Lucia C A

2017-09-01

This study evaluated a positive parenting program to Brazilian mothers who used corporal punishment with their children. The intervention was conducted in four agencies serving vulnerable children, and at a home replica laboratory at the University. Mothers who admitted using corporal punishment were randomly assigned between experimental (n=20) and control group (n=20). The program consisted of 12 individual sessions using one unit from Projeto Parceria (Partnership Project), with specific guidelines and materials on positive parenting, followed by observational sessions of mother-child interaction with live coaching and a video feedback session in the lab. The study used an equivalent group experimental design with pre/post-test and follow-up, in randomized controlled trials. Measures involved: Initial Interview; Strengths and Difficulties Questionnaire (SDQ) - parent and child versions; Beck Depression Inventory (BDI); observational sessions with a protocol; and a Program Evaluation by participants. Analysis of mixed models for repeated measures revealed significant positive effects on the BDI and SDQ total scores, as well as less Conduct problems and Hyperactivity in SDQ measures from the experimental group mothers, comparing pre with post-test. Observational data also indicated significant improvement in positive interaction from the experimental group mothers at post-test, in comparison with controls. No significant results were found, however, in children's observational measures. Limitations of the study involved using a restricted sample, among others. Implications for future research are suggested. Copyright © 2017 Elsevier Ltd. All rights reserved.

Crohn's Disease and Ulcerative Colitis: Emotional Factors

MedlinePlus

... for cures; participate in a clinical trial of experimental treatments. Interactive Disease Tracker Use GI Buddy to ... several coping strategies can help you gain better control over your condition. ... education, problem-solving, and positive reevaluation of distressing ...

The association of funding source on effect size in randomized controlled trials: 2013-2015 - a cross-sectional survey and meta-analysis.

PubMed

Falk Delgado, Alberto; Falk Delgado, Anna

2017-03-14

Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals. Parallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified. RCTs with binary primary endpoints were included. The primary outcome was the OR of patients' having a favorable outcome in the intervention group compared with the control group. The OR of a favorable outcome in each trial was calculated by the number of positive events that occurred in the intervention and control groups. A meta-analytic technique with random effects model was used to calculate summary OR. Data were stratified by funding source as for-profit, mixed, and nonprofit. Prespecified sensitivity, subgroup, and metaregression analyses were performed. Five hundred nine trials were included. The OR for a favorable outcome in for-profit-funded RCTs was 1.92 (95% CI 1.72-2.14), which was higher than mixed source-funded RCTs (OR 1.34, 95% CI 1.25-1.43) and nonprofit-funded RCTs (OR 1.32, 95% CI 1.26-1.39). The OR for a favorable outcome was higher for both clinical and surrogate endpoints in for-profit-funded trials than in RCTs with other funding sources. Excluding drug trials lowered the OR for a favorable outcome in for-profit-funded RCTs. The OR for a favorable surrogate outcome in drug trials was higher in for-profit-funded trials than in nonprofit-funded trials. For-profit-funded RCTs have a higher OR for a favorable outcome than nonprofit- and mixed source-funded RCTs. This difference is associated mainly with the use of surrogate endpoints in for-profit-financed drug trials.

Economic Evaluation of a Worksite Obesity Prevention and Intervention Trial among Hotel Workers in Hawaii

PubMed Central

Meenan, Richard T.; Vogt, Thomas M.; Williams, Andrew E.; Stevens, Victor J.; Albright, Cheryl L.; Nigg, Claudio

2010-01-01

Objective Economic evaluation of Work, Weight, and Wellness (3W), a two-year randomized trial of a weight loss program delivered through Hawaii hotel worksites. Methods Business case analysis from hotel perspective. Program resources were micro-costed (2008 dollars). Program benefits were reduced medical costs, fewer absences, and higher productivity. Primary outcome was discounted 24-month net present value (NPV). Results Control program cost $222K to implement over 24 months ($61 per participant), intervention program cost $1.12M ($334). Including overweight participants (body mass index > 25), discounted control NPV was −$217K; −$1.1M for intervention program. Presenteeism improvement of 50% combined with baseline 10% productivity shortfall required to generate positive 24-month intervention NPV. Conclusions 3W’s positive clinical outcomes did not translate into immediate economic benefit for participating hotels, although modest cost savings were observed in the trial’s second year. PMID:20061889

Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports: Findings from a Randomized Controlled Effectiveness Trial

ERIC Educational Resources Information Center

Bradshaw, Catherine P.; Waasdorp, Tracy E.; Leaf, Philip J.

2015-01-01

School-Wide Positive Behavioral Interventions and Supports (SWPBIS; Sugai & Horner, 2006) is currently implemented in over 20,000 schools across the country with the goal of preventing disruptive behavior problems and enhancing the school climate. While previous studies have indicated significant main effects of SWPBIS on student outcomes, the…

Examining the Effects of Schoolwide Positive Behavioral Interventions and Supports on Student Outcomes: Results from a Randomized Controlled Effectiveness Trial in Elementary Schools

ERIC Educational Resources Information Center

Bradshaw, Catherine P.; Mitchell, Mary M.; Leaf, Philip J.

2010-01-01

Schoolwide Positive Behavioral Interventions and Supports (SWPBIS) is a universal, schoolwide prevention strategy that is currently implemented in over 9,000 schools across the nation to reduce disruptive behavior problems through the application of behavioral, social learning, and organizational behavioral principles. SWPBIS aims to alter school…

Sleep Apnea and Cardiovascular Disease: Lessons From Recent Trials and Need for Team Science.

PubMed

Drager, Luciano F; McEvoy, R Doug; Barbe, Ferran; Lorenzi-Filho, Geraldo; Redline, Susan

2017-11-07

Emerging research highlights the complex interrelationships between sleep-disordered breathing and cardiovascular disease, presenting clinical and research opportunities as well as challenges. Patients presenting to cardiology clinics have a high prevalence of obstructive and central sleep apnea associated with Cheyne-Stokes respiration. Multiple mechanisms have been identified by which sleep disturbances adversely affect cardiovascular structure and function. Epidemiological research indicates that obstructive sleep apnea is associated with increases in the incidence and progression of coronary heart disease, heart failure, stroke, and atrial fibrillation. Central sleep apnea associated with Cheyne-Stokes respiration predicts incident heart failure and atrial fibrillation; among patients with heart failure, it strongly predicts mortality. Thus, a strong literature provides the mechanistic and empirical bases for considering obstructive sleep apnea and central sleep apnea associated with Cheyne-Stokes respiration as potentially modifiable risk factors for cardiovascular disease. Data from small trials provide evidence that treatment of obstructive sleep apnea with continuous positive airway pressure improves not only patient-reported outcomes such as sleepiness, quality of life, and mood but also intermediate cardiovascular end points such as blood pressure, cardiac ejection fraction, vascular parameters, and arrhythmias. However, data from large-scale randomized controlled trials do not currently support a role for positive pressure therapies for reducing cardiovascular mortality. The results of 2 recent large randomized controlled trials, published in 2015 and 2016, raise questions about the effectiveness of pressure therapies in reducing clinical end points, although 1 trial supported the beneficial effect of continuous positive airway pressure on quality of life, mood, and work absenteeism. This review provides a contextual framework for interpreting the results of recent studies, key clinical messages, and suggestions for future sleep and cardiovascular research, which include further consideration of individual risk factors, use of existing and new multimodality therapies that also address adherence, and implementation of trials that are sufficiently powered to target end points and to support subgroup analyses. These goals may best be addressed through strengthening collaboration among the cardiology, sleep medicine, and clinical trial communities. © 2017 American Heart Association, Inc.

First-line treatment for advanced ovarian cancer: paclitaxel, platinum and the evidence

PubMed Central

Sandercock, J; Parmar, M K B; Torri, V; Qian, W

2002-01-01

Four large randomised trials of paclitaxel in combination with platinum against a platinum-based control treatment have now been published in full, representing around 88% (3588 out of 4057) of patients randomised into the eight known trials of this question. There is substantial heterogeneity in the results of these four trials. Four main explanations for this heterogeneity have been proposed: differences in the extent and timing of ‘crossover’ to taxanes in the control groups; differences in the types of patient included; differences in the effectiveness of the research regimens used; differences in the effectiveness of the control regimens used. In this study we examine whether any of these explanations is consistent with the pattern of results seen in these trials. Each explanation suggests that a particular characteristic of each trial was responsible for the results observed. For each explanation the trials were split into groups according to that characteristic, in order to partition the total heterogeneity into that seen ‘within’ and ‘between’ groups of trials. If a particular explanation was consistent with the pattern of results, we would expect to see relatively little heterogeneity within each group of trial results viewed in this way, with most of the heterogeneity being between groups which are dissimilar with respect to the key characteristic. Heterogeneity ‘within’ and ‘between’ groups was formally compared using the F-ratio. If any explanation appeared to be consistent with the results of the trials, it was considered whether the explanation was also consistent with other evidence available about these regimens. Only one explanation appeared to be consistent with the pattern of results seen in these trials, and that was differences in effectiveness of the control arms used in these trials. This suggests that the very positive results in favour of paclitaxel/cisplatin seen in two of the trials may have been due to the use of a suboptimal control arm. There is no direct evidence about the relative effectiveness of the control arms used in these trials, but indirect evidence is consistent with the conclusion that the cyclophosphamide/cisplatin regimen used in two of the trials may be less effective than the control regimens used in the other trials. Specific concerns about the choice of a cyclophosphamide/cisplatin control arm in the first of these trials to report were raised before the results of the other trials were known, i.e. before any heterogeneity had been observed. Further investigation of this question would be useful. In the meantime, given all of the randomised evidence on the efficacy and toxicity associated with the regimens used in these trials, we conclude that single agent carboplatin is a safe and effective first-line treatment for women with advanced ovarian cancer. British Journal of Cancer (2002) 87, 815–824. doi:10.1038/sj.bjc.6600567 www.bjcancer.com © 2002 Cancer Research UK PMID:12373593

Does gratitude writing improve the mental health of psychotherapy clients? Evidence from a randomized controlled trial.

PubMed

Wong, Y Joel; Owen, Jesse; Gabana, Nicole T; Brown, Joshua W; McInnis, Sydney; Toth, Paul; Gilman, Lynn

2018-03-01

Although the past decade has witnessed growing research interest in positive psychological interventions (PPIs), their potential as adjunctive interventions for psychotherapy remains relatively unexplored. Therefore, this article expands the frontiers of PPI research by reporting the first randomized controlled trial to test a gratitude writing adjunctive intervention for psychotherapy clients. Participants were 293 adults seeking university-based psychotherapy services. Participants were randomly assigned to one of three conditions: (a) control (psychotherapy only), (b) a psychotherapy plus expressive writing, and (c) a psychotherapy plus gratitude writing. Participants in the gratitude condition wrote letters expressing gratitude to others, whereas those in the expressive writing condition wrote about their deepest thoughts and feelings about stressful experiences. About 4 weeks as well as 12 weeks after the conclusion of the writing intervention, participants in the gratitude condition reported significantly better mental health than those in the expressive and control conditions, whereas those in the expressive and control conditions did not differ significantly. Moreover, lower proportions of negative emotion words in participants' writing mediated the positive effect of condition (gratitude versus expressive writing) on mental health. These findings are discussed in light of the use of gratitude interventions as adjunctive interventions for psychotherapy clients.

Effects of Nursing Care Based on Watson's Theory of Human Caring on Anxiety, Distress, And Coping, When Infertility Treatment Fails: A Randomized Controlled Trial.

PubMed

Durgun Ozan, Yeter; Okumuş, Hülya

2017-06-01

Introduction: The failure of infertility treatment leads to individual, familial, and social problems. The objective of this study was to evaluate the effectiveness of the nursing care program based on Watson's "Theory of Human Caring" on anxiety and distress caused by coping when the treatment fails. Methods: This study randomized controlled trial study was conducted from April to November 2012, with 86 Turkish women with infertility (intervention group: 45, control group: 41). Follow-up of 32 infertile women, who failed infertility treatment from intervention group, and 35 infertile women, who failed infertility treatment from control group, continued for another four weeks. Data were collected through Spiel Berger's State/Trait Anxiety Inventory, Distress Scale, and Ways of Coping Questionnaire. The analyses of data were conducted using SPSS ver 13. Results: The intervention and control groups significantly differed in terms of anxiety, distress, and coping levels. The intervention group's mean anxiety score decreased by thirteen points and distress by fourteen points (in a positive direction). The intervention group's mean positive coping style score increased. Whereas a negative increase was observed in the control group's values depending on the failure of the treatment. Conclusion: Watson's theory of human caring is recommended as a guide to nursing patients with infertility treatment to decrease levels of anxiety and distress, and to increase the positive coping style among infertile women.

Effects of Nursing Care Based on Watson’s Theory of Human Caring on Anxiety, Distress, And Coping, When Infertility Treatment Fails: A Randomized Controlled Trial

PubMed Central

Durgun Ozan, Yeter; Okumuş, Hülya

2017-01-01

Introduction: The failure of infertility treatment leads to individual, familial, and social problems. The objective of this study was to evaluate the effectiveness of the nursing care program based on Watson’s "Theory of Human Caring" on anxiety and distress caused by coping when the treatment fails. Methods: This study randomized controlled trial study was conducted from April to November 2012, with 86 Turkish women with infertility (intervention group: 45, control group: 41). Follow-up of 32 infertile women, who failed infertility treatment from intervention group, and 35 infertile women, who failed infertility treatment from control group, continued for another four weeks. Data were collected through Spiel Berger’s State/Trait Anxiety Inventory, Distress Scale, and Ways of Coping Questionnaire. The analyses of data were conducted using SPSS ver 13. Results: The intervention and control groups significantly differed in terms of anxiety, distress, and coping levels. The intervention group’s mean anxiety score decreased by thirteen points and distress by fourteen points (in a positive direction). The intervention group’s mean positive coping style score increased. Whereas a negative increase was observed in the control group’s values depending on the failure of the treatment. Conclusion: Watson’s theory of human caring is recommended as a guide to nursing patients with infertility treatment to decrease levels of anxiety and distress, and to increase the positive coping style among infertile women. PMID:28680864

Tamoxifen with ovarian function suppression versus tamoxifen alone as an adjuvant treatment for premenopausal breast cancer: a meta-analysis of published randomized controlled trials

PubMed Central

Yan, Shunchao; Li, Kai; Jiao, Xin; Zou, Huawei

2015-01-01

Background Ovarian function suppression (OFS) significantly downregulates the concentration of plasma estrogens. However, it is unclear whether it offers any survival benefits if combined with adjuvant tamoxifen treatment in premenopausal women. This meta-analysis was designed to assess data from previous studies involving adjuvant tamoxifen treatment plus OFS in premenopausal breast cancer. Methods Electronic literature databases (PubMed, Embase, the Web of Science, and the Cochrane Library) were searched for relevant randomized controlled trials published prior to February 1, 2015. Only randomized controlled trials that compared tamoxifen alone with tamoxifen plus OFS for premenopausal women with breast cancer were selected. The evaluated endpoints were disease-free survival and overall survival. Results Four randomized controlled trials comprising 6,279 patients (OFS combination, n=3,133; tamoxifen alone, n=3,146) were included in the meta-analysis. There was no significant improvement in disease-free survival or overall survival with addition of OFS in either the whole population or the hormone receptor-positive subgroup. The risk of distant recurrence was not reduced with the addition of OFS in the whole population. A subgroup analysis showed that addition of OFS significantly improved overall survival in patients who were administered chemotherapy. Conclusion Based on the available studies, concurrent administration of OFS and adjuvant tamoxifen treatment for premenopausal women with breast cancer has no effect on prolonging disease-free survival and overall survival, excluding patients who were administered chemotherapy. It should not be widely recommended, except perhaps for women who were hormone-receptor positive and who were also administered adjuvant chemotherapy. PMID:26109867

The effectiveness of proprioceptive-based exercise for osteoarthritis of the knee: a systematic review and meta-analysis.

PubMed

Smith, Toby O; King, Jonathan J; Hing, Caroline B

2012-11-01

Osteoarthritis (OA) is a leading cause of functional impairment and pain. Proprioceptive defects may be associated with the onset and progression of OA of the knee. The purpose of this study was to determine the effectiveness of proprioceptive exercises for knee OA using meta-analysis. A systematic review was conducted on 12th December 2011 using published (Cochrane Library, MEDLINE, EMBASE, CINAHL, AMED, PubMed, PEDro) and unpublished/trial registry (OpenGrey, the WHO International Clinical Trials Registry Platform, Current Controlled Trials and the UK National Research Register Archive) databases. Studies were included if they were full publications of randomized or non-randomised controlled trials (RCT) comparing a proprioceptive exercise regime, against a non-proprioceptive exercise programme or non-treatment control for adults with knee OA. Methodological appraisal was performed using the PEDro checklist. Seven RCTs including 560 participants (203 males and 357 females) with a mean age of 63 years were eligible. The methodological quality of the evidence base was moderate. Compared to a non-treatment control, proprioceptive exercises significantly improved functional outcomes in people with knee OA during the first 8 weeks following commencement of their exercises (p < 0.02). When compared against a general non-proprioceptive exercise programme, proprioceptive exercises demonstrated similar outcomes, only providing superior results with respect to joint position sense-related measurements such as timed walk over uneven ground (p = 0.03) and joint position angulation error (p < 0.01). Proprioceptive exercises are efficacious in the treatment of knee OA. There is some evidence to indicate the effectiveness of proprioceptive exercises compared to general strengthening exercises in functional outcomes.

Effect of acupuncture and its influence on cerebral activity in perimenopausal insomniacs: study protocol for a randomized controlled trial.

PubMed

Wu, Xiao; Zhang, Wei; Qin, Yuanyuan; Liu, Xuguang; Wang, Zhengyan

2017-08-14

Perimenopausal insomnia is one of the core symptoms of the menopausal transition. Acupuncture is considered to exert a positive effect on restoring the normal sleep-wake cycle. However, there is little intuitive evidence besides evaluation using clinical effectiveness scales. We therefore designed this study, aiming to use more intuitive and reliable detection techniques such as functional magnetic resonance imaging before and after applying acupuncture to provide neuroimaging evidence, as well as to verify the effectiveness with other curative effect indicators. This study is a randomized, assessor-statistician-blinded, positive medicine controlled trial involving 40 participants. A total of 40 eligible patients with perimenopausal insomnia will be randomly assigned to two groups in a 1:1 ratio as an intervention group using acupuncture and a control group taking estazolam. Participants in the intervention group will receive six acupuncture treatment sessions per week for 4 consecutive weeks, for a total of 24 sessions during the study. Meanwhile, the medicine control group will be prescribed estazolam 1-2 mg/day to be taken 30 minutes before sleep for 4 weeks. The primary outcome is the Pittsburgh Sleep Quality Index. Secondary outcomes are the micro-movement sensitive mattress-type sleep monitoring system, the Hamilton Depression Scale, and the Hamilton Anxiety Scale. All outcomes will be evaluated before and after treatment. The safety of interventions will be assessed at every visit. The results of this trial, which will be available in 2018, will investigate the impact of acupuncture treating perimenopausal insomnia from assessment of the sleep architecture, hormone level, and emotional-circuit neurological function, and will uncover the effective mechanism of acupuncture regulating the emotional center integrated effect. Chinese Clinical Trials Register, ChCTR-IPC-16007832 . Registered on 26 January 2016.

Learned Manipulation at Unconstrained Contacts Does Not Transfer across Hands

PubMed Central

Fu, Qiushi; Choi, Jason Y.; Gordon, Andrew M.; Jesunathadas, Mark; Santello, Marco

2014-01-01

Recent studies about sensorimotor control of the human hand have focused on how dexterous manipulation is learned and generalized. Here we address this question by testing the extent to which learned manipulation can be transferred when the contralateral hand is used and/or object orientation is reversed. We asked subjects to use a precision grip to lift a grip device with an asymmetrical mass distribution while minimizing object roll during lifting by generating a compensatory torque. Subjects were allowed to grasp anywhere on the object’s vertical surfaces, and were therefore able to modulate both digit positions and forces. After every block of eight trials performed in one manipulation context (i.e., using the right hand and at a given object orientation), subjects had to lift the same object in the second context for one trial (transfer trial). Context changes were made by asking subjects to switch the hand used to lift the object and/or rotate the object 180° about a vertical axis. Therefore, three transfer conditions, hand switch (HS), object rotation (OR), and both hand switch and object rotation (HS+OR), were tested and compared with hand matched control groups who did not experience context changes. We found that subjects in all transfer conditions adapted digit positions across multiple transfer trials similar to the learning of control groups, regardless of different changes of contexts. Moreover, subjects in both HS and HS+OR group also adapted digit forces similar to the control group, suggesting independent learning of the left hand. In contrast, the OR group showed significant negative transfer of the compensatory torque due to an inability to adapt digit forces. Our results indicate that internal representations of dexterous manipulation tasks may be primarily built through the hand used for learning and cannot be transferred across hands. PMID:25233091

Safety and immunogenicity of a live attenuated mumps vaccine

PubMed Central

Liang, Yan; Ma, Jingchen; Li, Changgui; Chen, Yuguo; Liu, Longding; Liao, Yun; Zhang, Ying; Jiang, Li; Wang, Xuan-Yi; Che, Yanchun; Deng, Wei; Li, Hong; Cui, Xiaoyu; Ma, Na; Ding, Dong; Xie, Zhongping; Cui, Pingfang; Ji, Qiuyan; Wang, Jingjing; Zhao, Yuliang; Wang, Junzhi; Li, Qihan

2014-01-01

Background: Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas. Methods: A randomized, double-blind, controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted. A total of 300 subjects were enrolled and divided into 4 age groups: 16–60 years, 5–16 years, 2–5 years and 8–24 months. The groups were immunized with one injection per subject. Three different doses of the F-genotype attenuated mumps vaccine, A (3.5 ± 0.25 logCCID50), B (4.25 ± 0.25 logCCID50) and C (5.0 ± 0.25 logCCID50), as well as a placebo control and a positive control of a licensed A-genotype vaccine (S79 strain) were used. The safety and immunogenicity of this vaccine were compared with those of the controls. Results: The safety evaluation suggested that mild adverse reactions were observed in all groups. No serious adverse event (SAE) was reported throughout the trial. The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2- to 5-year-old and 8- to 24-month-old groups compared with the seroconversion rate in the positive control. The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group. Conclusions: The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control. PMID:24614759

A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

PubMed

Felicitas-Perkins, Jamie Q; Palalay, Melvin Paul; Cuaresma, Charlene; Ho, Reginald Cs; Chen, Moon S; Dang, Julie; Loui, William S

2017-07-01

We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment ( P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them ( P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women.

PubMed

Hilton, Paul; Armstrong, Natalie; Brennand, Catherine; Howel, Denise; Shen, Jing; Bryant, Andrew; Tincello, Douglas G; Lucas, Malcolm G; Buckley, Brian S; Chapple, Christopher R; Homer, Tara; Vale, Luke; McColl, Elaine

2015-02-01

The position of invasive urodynamic testing in the diagnostic pathway for urinary incontinence (UI) is unclear. Systematic reviews have called for further trials evaluating clinical utility, although a preliminary feasibility study was considered appropriate. To inform the decision whether or not to proceed to a definitive randomised trial of invasive urodynamic testing compared with clinical assessment with non-invasive tests, prior to surgery in women with stress UI (SUI) or stress predominant mixed UI (MUI). A mixed-methods study comprising a pragmatic multicentre randomised pilot trial; economic evaluation; survey of clinicians' views about invasive urodynamic testing; qualitative interviews with clinicians and trial participants. Urogynaecology, female urology and general gynaecology units in Newcastle, Leicester, Swansea, Sheffield, Northumberland, Gateshead and South Tees. Trial recruits were women with SUI or stress predominant MUI who were considering surgery after unsuccessful conservative treatment. Relevant clinicians completed two online surveys. Subsets of survey respondents and trial participants took part in separate qualitative interview studies. Pilot trial participants were randomised to undergo clinical assessment with non-invasive tests (control arm); or assessment as controls, plus invasive urodynamic testing (intervention arm). Confirmation that units can identify and recruit eligible women; acceptability of investigation strategies and data collection tools; acquisition of outcome data to determine the sample size for a definitive trial. The proposed primary outcome for the definitive trial was International Consultation on Incontinence Modular Questionnaire (ICIQ) Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (total score) 6 months after surgery or the start of non-surgical treatment; secondary outcomes included: ICIQ-FLUTS (subscales); ICIQ Urinary Incontinence Short Form; ICIQ Lower Urinary Tract Symptoms Quality of Life; Urogenital Distress Inventory; EuroQol-5D; costs, quality-adjusted life-years (QALYs) and incremental cost per QALY, Short Form 12; 3-day bladder diary. Of 284 eligible women, 222 (78%) were recruited; 165/219 (75%) returned questionnaires at baseline and 125/200 (63%) who were sent questionnaires at follow-up. There were few missing data items in returned questionnaires, with individual outcome scales calculable for 81%-94%. Most women underwent surgery; management plans were changed in 19 (19%) participants following invasive urodynamic testing. Participant Costs Questionnaires were returned by 53% 6 months after treatment; complete data to undertake cost-utility analysis were available in 27% (intervention) and 47% (control). While insufficient to recommend changes in practice, the results suggest further research would be valuable. All clinicians responding to the survey had access to invasive urodynamic testing, and most saw it as essential prior to surgery in women with SUI with or without other symptoms; nevertheless, 70% considered the research question underlying INVESTIGATE important and most were willing to randomise patients in a definitive trial. Participants interviewed were positive about the trial and associated documentation; the desire of some women to avoid invasive urodynamic testing contrasted with opinions expressed by clinicians through both survey and interview responses. All elements of a definitive trial and economic evaluation were rehearsed; several areas for protocol modification were identified. Such a trial would require to 400-900 participants, depending on the difference in primary outcome sought. A definitive trial of invasive urodynamic testing versus clinical assessment prior to surgery for SUI or stress predominant MUI should be undertaken. Current Controlled Trials ISRCTN71327395. The National Institute for Health Research Health Technology Assessment programme.

Effect of exercise on cognitive function in chronic disease patients: a meta-analysis and systematic review of randomized controlled trials.

PubMed

Cai, Hong; Li, Guichen; Hua, Shanshan; Liu, Yufei; Chen, Li

2017-01-01

The purpose of this study was to conduct a meta-analysis and systematic review to assess the effect of exercise on cognitive function in people with chronic diseases. PubMed, Web of Science, Embase, the Cochrane Library, CINAHL, PsycINFO, and three Chinese databases were electronically searched for papers that were published until September 2016. This meta-analysis and systematic review included randomized controlled trials that evaluated the effect of exercise on cognitive function compared with control group for people with chronic diseases. Totally, 35 studies met the inclusion criteria, with 3,113 participants. The main analysis revealed a positive overall random effect of exercise intervention on cognitive function in patients with chronic diseases. The secondary analysis revealed that aerobic exercise interventions and aerobic included exercise interventions had a positive effect on cognition in patients with chronic diseases. The intervention offering low frequency had a positive effect on cognitive function in patients with chronic diseases. Finally, we found that interventions offered at both low exercise intensity and moderate exercise intensity had a positive effect on cognitive function in patients with chronic diseases. The secondary analysis also revealed that exercise interventions were beneficial in Alzheimer's disease patients when grouped by disease type. This meta-analysis and systematic review suggests that exercise interventions positively influence cognitive function in patients with chronic diseases. Beneficial effect was independent of the type of disease, type of exercise, frequency, and the intensity of the exercise intervention.

Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.

PubMed

Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

2016-07-29

Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life. Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention. Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea gathering session in improving subjective happiness (β = .00, p = .990, d = .00) or mental (β = 1.20, p = 1.000, d = -.04) and physical quality of life (β = .15, p = 1.000, d = -.01). The analyses extend previous findings of salutary effects on family well-being by showing that positive psychology family interventions can improve subjective happiness. Suggestions for future research are proposed. ClinicalTrials.gov NCT01796275 . Retrospectively registered 19 February 2013.

Sequential Modulations in a Combined Horizontal and Vertical Simon Task: Is There ERP Evidence for Feature Integration Effects?

PubMed Central

Hoppe, Katharina; Küper, Kristina; Wascher, Edmund

2017-01-01

In the Simon task, participants respond faster when the task-irrelevant stimulus position and the response position are corresponding, for example on the same side, compared to when they have a non-corresponding relation. Interestingly, this Simon effect is reduced after non-corresponding trials. Such sequential effects can be explained in terms of a more focused processing of the relevant stimulus dimension due to increased cognitive control, which transfers from the previous non-corresponding trial (conflict adaptation effects). Alternatively, sequential modulations of the Simon effect can also be due to the degree of trial-to-trial repetitions and alternations of task features, which is confounded with the correspondence sequence (feature integration effects). In the present study, we used a spatially two-dimensional Simon task with vertical response keys to examine the contribution of adaptive cognitive control and feature integration processes to the sequential modulation of the Simon effect. The two-dimensional Simon task creates correspondences in the vertical as well as in the horizontal dimension. A trial-by-trial alternation of the spatial dimension, for example from a vertical to a horizontal stimulus presentation, generates a subset containing no complete repetitions of task features, but only complete alternations and partial repetitions, which are equally distributed over all correspondence sequences. In line with the assumed feature integration effects, we found sequential modulations of the Simon effect only when the spatial dimension repeated. At least for the horizontal dimension, this pattern was confirmed by the parietal P3b, an event-related potential that is assumed to reflect stimulus–response link processes. Contrary to conflict adaptation effects, cognitive control, measured by the fronto-central N2 component of the EEG, was not sequentially modulated. Overall, our data provide behavioral as well as electrophysiological evidence for feature integration effects contributing to sequential modulations of the Simon effect. PMID:28713305

Sequential Modulations in a Combined Horizontal and Vertical Simon Task: Is There ERP Evidence for Feature Integration Effects?

PubMed

Hoppe, Katharina; Küper, Kristina; Wascher, Edmund

2017-01-01

In the Simon task, participants respond faster when the task-irrelevant stimulus position and the response position are corresponding, for example on the same side, compared to when they have a non-corresponding relation. Interestingly, this Simon effect is reduced after non-corresponding trials. Such sequential effects can be explained in terms of a more focused processing of the relevant stimulus dimension due to increased cognitive control, which transfers from the previous non-corresponding trial (conflict adaptation effects). Alternatively, sequential modulations of the Simon effect can also be due to the degree of trial-to-trial repetitions and alternations of task features, which is confounded with the correspondence sequence (feature integration effects). In the present study, we used a spatially two-dimensional Simon task with vertical response keys to examine the contribution of adaptive cognitive control and feature integration processes to the sequential modulation of the Simon effect. The two-dimensional Simon task creates correspondences in the vertical as well as in the horizontal dimension. A trial-by-trial alternation of the spatial dimension, for example from a vertical to a horizontal stimulus presentation, generates a subset containing no complete repetitions of task features, but only complete alternations and partial repetitions, which are equally distributed over all correspondence sequences. In line with the assumed feature integration effects, we found sequential modulations of the Simon effect only when the spatial dimension repeated. At least for the horizontal dimension, this pattern was confirmed by the parietal P3b, an event-related potential that is assumed to reflect stimulus-response link processes. Contrary to conflict adaptation effects, cognitive control, measured by the fronto-central N2 component of the EEG, was not sequentially modulated. Overall, our data provide behavioral as well as electrophysiological evidence for feature integration effects contributing to sequential modulations of the Simon effect.

Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial

PubMed Central

Komasawa, Nobuyasu; Mihara, Ryosuke; Imagawa, Kentaro; Hattori, Kazuo; Minami, Toshiaki

2015-01-01

The present study compared changes in cuff pressure by head and neck position between high-volume low-pressure (HVLP) and taper-shaped (taper) cuffs in a prospective randomized clinical trial. Methods. Forty patients were intubated using tracheal tubes with either HVLP (n = 20; HVLP group) or taper-shaped (n = 20; Taper group) cuffs. Initial cuff pressure was adjusted to 15, 20, or 25 cmH2O in the neutral position. Cuff pressure was evaluated after changing the head and neck positions to flexion, extension, and rotation. Results. Cuff pressure significantly increased with flexion in both HVLP and Taper groups at all initial cuff pressures. It significantly increased with extension in the HVLP group, but not in the Taper group. Cuff pressure did not significantly differ with rotation in either group and was significantly smaller in the Taper group during flexion and extension than in the HVLP group, regardless of initial cuff pressure. Conclusion. Cuff pressure changes with head and neck flexion and extension were smaller in the Taper group than in the HVLP group. Our results highlight the potential for taper cuffs to prevent excessive cuff pressure increases with positional changes in the head and neck. This trial is registered with UMIN000016119. PMID:26509152

Randomized Clinical Trial of Real-Time fMRI Amygdala Neurofeedback for Major Depressive Disorder: Effects on Symptoms and Autobiographical Memory Recall.

PubMed

Young, Kymberly D; Siegle, Greg J; Zotev, Vadim; Phillips, Raquel; Misaki, Masaya; Yuan, Han; Drevets, Wayne C; Bodurka, Jerzy

2017-08-01

Patients with depression show blunted amygdala hemodynamic activity to positive stimuli, including autobiographical memories. The authors examined the therapeutic efficacy of real-time functional MRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's hemodynamic response to positive memories in patients with depression. In a double-blind, placebo-controlled, randomized clinical trial, unmedicated adults with depression (N=36) were randomly assigned to receive two sessions of rtfMRI-nf either from the amygdala (N=19) or from a parietal control region not involved in emotional processing (N=17). Clinical scores and autobiographical memory performance were assessed at baseline and 1 week after the final rtfMRI-nf session. The primary outcome measure was change in score on the Montgomery-Åsberg Depression Rating Scale (MADRS), and the main analytic approach consisted of a linear mixed-model analysis. In participants in the experimental group, the hemodynamic response in the amygdala increased relative to their own baseline and to the control group. Twelve participants in the amygdala rtfMRI-nf group, compared with only two in the control group, had a >50% decrease in MADRS score. Six participants in the experimental group, compared with one in the control group, met conventional criteria for remission at study end, resulting in a number needed to treat of 4. In participants receiving amygdala rtfMRI-nf, the percent of positive specific memories recalled increased relative to baseline and to the control group. rtfMRI-nf training to increase the amygdala hemodynamic response to positive memories significantly decreased depressive symptoms and increased the percent of specific memories recalled on an autobiographical memory test. These data support a role of the amygdala in recovery from depression.

An randomized controlled trial of Post-it® notes did not increase postal response rates in older depressed participants.

PubMed

Lewis, Helen; Keding, Ada; Bosanquet, Katharine; Gilbody, Simon; Torgerson, David

2017-02-01

Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER + and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes (P of interaction = .019). There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. © 2016 John Wiley & Sons, Ltd.

Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

PubMed

Mohammed, Shama; Glennerster, Rachel; Khan, Aamir J

2016-01-01

The rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes. To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis. We conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day. Public and private sector tuberculosis clinics in Karachi, Pakistan. Newly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group. The primary outcome was clinically recorded treatment success based upon intention-to-treat. We found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment. In this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact. The trial was registered with ClinicalTrials.gov, NCT01690754.

Corticosteroids for tuberculous pleurisy

PubMed Central

Ryan, Hannah; Yoo, Jinho; Darsini, Padmapriya

2017-01-01

Background Corticosteroids used in addition to antituberculous therapy have been reported to benefit people with tuberculous pleurisy. However, research findings are inconsistent and raise doubt as to whether such treatment is worthwhile. There is also concern regarding the potential adverse effects of corticosteroids, especially in HIV-positive people. Objectives To evaluate the effects of adding corticosteroids to drug regimens for tuberculous pleural effusion. Search methods In April 2016, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, LILACS, Current Controlled Trials, and the reference lists of articles identified by the literature search. Selection criteria Randomized controlled trials (RCTs) and quasi-RCTs that compared any corticosteroid with no treatment, placebo, or other active treatment (both groups should have received the same antituberculous drug regimen) in people diagnosed with tuberculous pleurisy. Data collection and analysis Two review authors independently screened the search results, extracted data from the included trials, and assessed trial methodological quality using the Cochrane 'Risk of bias' tool. We analysed the data using risk ratios (RR) with 95% confidence intervals (CIs). We applied the fixed-effect model in the absence of statistically significant heterogeneity. Main results Six trials with 590 participants met the inclusion criteria, which were conducted in Asia (three trials), Africa (two trials), and Europe (one trial). Two trials were in HIV-negative people, one trial was in HIV-positive people, and three trials did not report HIV status. Corticosteroids may reduce the time to resolution of pleural effusion. Risk of residual pleural effusion on chest X-ray was reduced by 45% at eight weeks (RR 0.54, 95% CI 0.37 to 0.78; 237 participants, 2 trials, low certainty evidence), and 65% at 24 weeks (RR 0.35, 95% CI 0.18 to 0.66; 237 participants, 2 trials, low certainty evidence). Compared with control, corticosteroids may reduce the risk of having pleural changes (such as pleural thickening or pleural adhesions), on chest X-ray at the end of follow-up by almost one third (RR 0.72, 95% CI 0.57 to 0.92; 393 participants, 5 trials,low certainty evidence), which translates to an absolute risk reduction of 16%. One trial reported deaths in people that were HIV-positive, with no obvious difference between the groups; the trial authors' analysis suggests that the deaths observed in this trial were related to HIV disease rather than pleural TB (RR 0.91, 95% CI 0.64 to 1.31; 197 participants, 1 trial). We found limited data on long-term functional respiratory impairment on 187 people in two trials, which reported that average percentage predicted forced vital capacity was similar in the group receiving prednisolone and in the control group (very low certainty evidence). The risk of adverse events that led to discontinuation of the trial drug was higher in people with pleural TB receiving corticosteroids (RR 2.78, 95% CI 1.11 to 6.94; 587 participants, 6 trials, low certainty evidence). The trial in HIV-positive people reported on six different HIV-related infections, with no obvious differences. However, cases of Kaposi's sarcoma were only seen in the corticosteroid group (with 6/99 cases in the steroid group compared to 0/98 in the control group) (very low certainty evidence). Authors' conclusions Long-term respiratory function is potentially the most important outcome for assessing the effects of adjunctive treatments for people with pleural TB. However, the information on the impact of pleural TB on long-term respiratory function is unknown and could be eclipsed by other risk factors, such as concurrent pulmonary TB, smoking, and HIV. This probably needs to be quantified to help decide whether further trials of corticosteroids for pleural TB would be worthwhile. What is tuberculous pleurisy and how might corticosteroids work? Tuberculous pleurisy results from inflammation of the membrane that covers the lungs (the pleura) caused by exposure to Mycobacterium tuberculosis bacteria infecting the lungs. This results in a build up of fluid around the lung (pleural effusion) that causes pain and fever, impairs breathing, and may lead to impairment of lung function in the long term. Some clinicians believe that corticosteroids used in combination with antituberculous drugs can speed up the recovery from TB pleurisy and help to prevent long-term complications. What the evidence shows We examined the available evidence up to 13 April 2016 and included six trials with 590 people, which evaluated prednisolone given with antituberculous treatment (ATT). One included trial was of high quality, while the rest had uncertainties regarding trial quality. All the included trials were in adults; one trial included only HIV-positive people, two included only HIV-negative people, and three did not report the HIV status of the participants. Corticosteroids may reduce the time to resolution of the symptoms of TB pleurisy and the time to resolution of the pleural effusion on chest X-ray (low certainty evidence). Corticosteroids may also reduce the risk of having signs of pleural scarring on chest X-ray (pleural thickening and pleural adhesions) after the disease has resolved (low certainty evidence). There was not enough information about lung function to be sure whether or not corticosteroids reduce the risk of lung function impairment after TB pleurisy (very low certainty evidence). Corticosteroids may increase the risk of adverse events leading to discontinuation of the trial drug (low certainty evidence). From one trial in people living with HIV, there was no detectable increase in HIV-related conditions with corticosteroids, although cases of Kaposi's sarcoma were only seen in the corticosteroid group and numbers of participants and events were too small to rule out an effect of corticosteroids (very low certainty evidence). As the risk of disability and long-term illness after TB pleurisy is unclear, research looking at the association between TB pleurisy and lung function impairment would be useful to inform future research into corticosteroids for TB pleurisy. PMID:28290161

The effect of micronutrient supplementation on treatment outcome in patients with pulmonary tuberculosis: a randomized controlled trial in Mwanza, Tanzania.

PubMed

Range, Nyagosya; Andersen, Ase B; Magnussen, Pascal; Mugomela, Apolinary; Friis, Henrik

2005-09-01

The aim of the study was to assess the effects of micronutrient supplementation on culture conversion in tuberculosis (TB) patients. The study was a randomized, double-blind placebo-controlled 2 x 2 trial of zinc and multi-micronutrient (MMN) supplementation in pulmonary TB patients in Tanzania. A total of 499 pulmonary TB patients were included in the trial after being confirmed sputum-positive by microscopy or culture. At 8 weeks, 25% were sputum-smear positive but only 11% were culture-positive (P<0.0001). No significant differences were observed in culture conversion rate among those allocated to MMN or placebo (89.5 vs. 86.2%, P=0.29) at 8 weeks, although at week 4 those allocated to MMN had a slightly reduced culture conversion rate (42.8 vs. 52.8%, P=0.058). Zinc had no effects on culture conversion. MMN increased weight gain by 0.78 kg [95% confidence interval (CI): 0.12--1.43] at week 8, while zinc supplementation had no effect. The effects of MMN and zinc did not interact and neither MMN nor zinc interacted with human immunodeficiency virus status, sex and culture-intensity at baseline. Neither zinc nor MMN supplementation had significant effects on culture conversion, but MMN supplementation increased weight gain in TB patients.

Dissociable neural systems underwrite logical reasoning in the context of induced emotions with positive and negative valence.

PubMed

Smith, Kathleen W; Vartanian, Oshin; Goel, Vinod

2014-01-01

How emotions influence syllogistic reasoning is not well understood. fMRI was employed to investigate the effects of induced positive or negative emotion on syllogistic reasoning. Specifically, on a trial-by-trial basis participants were exposed to a positive, negative, or neutral picture, immediately prior to engagement in a reasoning task. After viewing and rating the valence and intensity of each picture, participants indicated by keypress whether or not the conclusion of the syllogism followed logically from the premises. The content of all syllogisms was neutral, and the influence of belief-bias was controlled for in the study design. Emotion did not affect reasoning performance, although there was a trend in the expected direction based on accuracy rates for the positive (63%) and negative (64%) versus neutral (70%) condition. Nevertheless, exposure to positive and negative pictures led to dissociable patterns of neural activation during reasoning. Therefore, the neural basis of deductive reasoning differs as a function of the valence of the context.

Dissociable Neural Systems Underwrite Logical Reasoning in the Context of Induced Emotions with Positive and Negative Valence

PubMed Central

Smith, Kathleen W.; Vartanian, Oshin; Goel, Vinod

2014-01-01

How emotions influence syllogistic reasoning is not well understood. fMRI was employed to investigate the effects of induced positive or negative emotion on syllogistic reasoning. Specifically, on a trial-by-trial basis participants were exposed to a positive, negative, or neutral picture, immediately prior to engagement in a reasoning task. After viewing and rating the valence and intensity of each picture, participants indicated by keypress whether or not the conclusion of the syllogism followed logically from the premises. The content of all syllogisms was neutral, and the influence of belief-bias was controlled for in the study design. Emotion did not affect reasoning performance, although there was a trend in the expected direction based on accuracy rates for the positive (63%) and negative (64%) versus neutral (70%) condition. Nevertheless, exposure to positive and negative pictures led to dissociable patterns of neural activation during reasoning. Therefore, the neural basis of deductive reasoning differs as a function of the valence of the context. PMID:25294997

Positive Outlook as a Moderator of the Effectiveness of an HIV/STI Intervention with Adolescents in Detention

ERIC Educational Resources Information Center

Schmiege, Sarah J.; Ewing, Sarah W. Feldstein; Hendershot, Christian S.; Bryan, Angela D.

2011-01-01

Justice-involved adolescents engage in high levels of risky sexual behavior, underscoring the need for targeted, effective, prevention interventions geared toward this population. In a randomized controlled trial, 484 detained adolescents received a theory-based intervention or an information-only control. We have previously demonstrated that the…

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

PubMed Central

Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John

2017-01-01

Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding. Design Cross sectional study of randomized controlled trials (RCTs). Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013. Participants Random sample of RCTs focused on drug efficacy. Main outcome measure Association between financial ties of principal investigators and study outcome. Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9). Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base. PMID:28096109

Vitamin E for the treatment of children with hepatitis B e antigen-positive chronic hepatitis: A systematic review and meta-analysis.

PubMed

Fiorino, Sirio; Bacchi-Reggiani, Maria Letizia; Leandri, Paolo; Loggi, Elisabetta; Andreone, Pietro

2017-02-28

To assess vitamin E efficacy, defined as its ability to induce hepatitis B e antigen (HBeAg) seroconversion, in children with HBeAg-positive persistent hepatitis. In July 2016, we extracted articles published in MEDLINE and the Cochrane Library using the following search terms: "chronic hepatitis B", "children", "childhood", "therapy", "treatment", "vitamin E", "tocopherols", "tocotrienols". Only randomized controlled trials (RCTs) published in English language were collected. Three RCTs met inclusion criteria and were considered in the present meta-analysis. Overall, 23/122 children in the treatment group underwent HBeAg seroconversion vs 3/74 in the control group (OR = 3.96, 95%CI: 1.18-13.25, P = 0.025). Although our meta-analysis has several limits, including the very small number of available studies and enrolled children with HBeAg positivity-related hepatitis, it suggests that vitamin E use may enhance the probability to induce HBeAg seroconversion in these patients. Further well designed and adequately sized trials are required to confirm or deny these very preliminary results.

Assessment of a head support system to prevent pediatric out-of-position: an observational study.

PubMed

Lopez-Valdes, Francisco J; Forman, Jason L; Ash, Joseph H; Kent, Richard; Alba, Juan J; Segui-Gomez, Maria

Head injuries are the most common severe injuries sustained by pediatric occupants in road traffic crashes. Preventing children from adopting positions that can result in an increased injury risk due to unfavorable interactions with the restraints is fundamental. The objective of this paper was to assess the effect of a head support system (SS) on the lateral position of the head, the vertical position of the sternum and the shoulder belt fit. Thirty pediatric rear-seat passengers were exposed to two 75-minute trials. Volunteers were restrained by a three-point belt and, if needed, used the appropriate child restraint system for their anthropometry (high-back booster, low-back booster, no booster). A case crossover study was designed in which the volunteers used the head support system (SS) during one of the trials, acting as their own controls (No SS) in the other. Compared to the control group, the head support reduced significantly the 90(th) percentile value of the absolute value of the relative lateral motion of the head, regardless of the restraint used. The system also reduced the maximum downward position of the sternal notch within the low-back booster group. As for the belt fit, the use of the head support improved significantly the position of the shoulder belt on the occupant in the low-back booster and in the no booster groups.

Assessment of a head support system to prevent pediatric out-of-position: an observational study

PubMed Central

Lopez-Valdes, Francisco J.; Forman, Jason L.; Ash, Joseph H.; Kent, Richard; Alba, Juan J.; Segui-Gomez, Maria

2013-01-01

Head injuries are the most common severe injuries sustained by pediatric occupants in road traffic crashes. Preventing children from adopting positions that can result in an increased injury risk due to unfavorable interactions with the restraints is fundamental. The objective of this paper was to assess the effect of a head support system (SS) on the lateral position of the head, the vertical position of the sternum and the shoulder belt fit. Thirty pediatric rear-seat passengers were exposed to two 75-minute trials. Volunteers were restrained by a three-point belt and, if needed, used the appropriate child restraint system for their anthropometry (high-back booster, low-back booster, no booster). A case crossover study was designed in which the volunteers used the head support system (SS) during one of the trials, acting as their own controls (No SS) in the other. Compared to the control group, the head support reduced significantly the 90th percentile value of the absolute value of the relative lateral motion of the head, regardless of the restraint used. The system also reduced the maximum downward position of the sternal notch within the low-back booster group. As for the belt fit, the use of the head support improved significantly the position of the shoulder belt on the occupant in the low-back booster and in the no booster groups. PMID:24406966

The Sources of Strength Australia Project: study protocol for a cluster randomised controlled trial.

PubMed

Calear, Alison L; Brewer, Jacqueline L; Batterham, Philip J; Mackinnon, Andrew; Wyman, Peter A; LoMurray, Mark; Shand, Fiona; Kazan, Dominique; Christensen, Helen

2016-07-26

The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for suicide. However, in Australia, suicide-prevention programs that are routinely delivered in the schools are lacking. Internationally, evidence exists for the effectiveness of peer-led interventions that take a social connectedness approach to improve help-seeking for suicide. The aim of the current trial is to test the effectiveness of the Sources of Strength program to promote help-seeking for suicide in adolescents in Australian high schools. This study is a two-arm, cluster-randomised, controlled trial that will compare the evidence-based Sources of Strength program to a wait-list control condition. Sixteen Australian high schools will be recruited to the trial, with all adolescents in years 7 to 10 (12-16 years of age) invited to participate. Peer leaders from intervention-condition schools will receive training in the Sources of Strength program and will integrate positive messages, across 3 months, with the support of adult advisors. Activities may take the form of class presentations, posters, videos, and messages on social media sites and will aim to change help-seeking norms, strengthen youth-adult connections, and promote positive coping. The primary outcome measure for the study is help-seeking intentions, whereas secondary outcomes include help-seeking behaviour, help-seeking attitudes and norms, referral of distressed peers, availability of adult help, positive coping, and suicidal behaviour. Data will be collected pre-intervention, post-intervention (after the initial 3 months of messaging), and at the end of the first (6-month follow-up) and the second year after implementation (18-month follow-up). Primary analyses will compare changes in help-seeking intentions for the intervention condition relative to the wait-list control condition using mixed-effect repeated-measures analyses to account for clustering within schools. If proven effective, this universal social connectedness program for suicide could be more widely delivered in Australian high schools, providing a valuable new resource. The Sources of Strength program has the potential to significantly contribute to the mental health of young people in Australia by improving help-seeking for suicide. The findings from this research will also contribute to the evidence-base for peer-leadership programs internationally. Australian New Zealand Clinical Trials Registry, ACTRN12616000048482 . Registered on 19 January 2016.

Increasing retention in care of HIV-positive women in PMTCT services through continuous quality improvement-breakthrough (CQI-BTS) series in primary and secondary health care facilities in Nigeria: a cluster randomized controlled trial. The Lafiyan Jikin Mata Study.

PubMed

Oyeledun, Bolanle; Oronsaye, Frank; Oyelade, Taiwo; Becquet, Renaud; Odoh, Deborah; Anyaike, Chukwuma; Ogirima, Francis; Ameh, Bernice; Ajibola, Abiola; Osibo, Bamidele; Imarhiagbe, Collins; Abutu, Inedu

2014-11-01

Rates of retention in care of HIV-positive pregnant women in care programs in Nigeria remain generally poor with rates around 40% reported for specific programs. Poor quality of services in health facilities and long waiting times are among the critical factors militating against retention of these women in care. The aim of the interventions in this study is to assess whether a continuous quality improvement intervention using a Breakthrough Series approach in local district hospitals and primary health care clinics will lead to improved retention of HIV-positive women and mothers. A cluster randomized controlled trial with 32 health facilities randomized to receive a continuous quality improvement/Breakthrough Series intervention or not. The care protocol for HIV-infected pregnant women and mothers is the same in all sites. The quality improvement intervention started 4 months before enrollment of individual HIV-infected pregnant women and initially focused on reducing waiting times for women and also ensuring that antiretroviral drugs are dispensed on the same day as clinic attendance. The primary outcome measure is retention of HIV-positive mothers in care at 6 months postpartum. Results of this trial will inform whether quality improvement interventions are an effective means of improving retention in prevention of mother-to-child transmission of HIV programs and will also guide where health system interventions should focus to improve the quality of care for HIV-positive women. This will benefit policymakers and program managers as they seek to improve retention rates in HIV care programs.

Prevention of depression and anxiety in later life: design of a randomized controlled trial for the clinical and economic evaluation of a life-review intervention

PubMed Central

Korte, Jojanneke; Bohlmeijer, Ernst T; Smit, Filip

2009-01-01

Background Depressive and anxiety symptoms in older adults could develop into significant health problems with detrimental effects on quality of life and a possibly poor prognosis. Therefore, there is a need for preventive interventions which are at once effective, acceptable and economic affordable. Methods and design This paper describes the design of a study evaluating "The stories we live by", a preventive life-review group intervention, which was recently developed for adults of 55 years and over with depressive and anxiety symptoms. Both clinical and economic effectiveness will be evaluated in a pragmatic randomized controlled trial. The participants in the intervention condition will receive the 8-session preventive intervention. The participants in the control condition will have access to usual care. Clinical end-terms are depressive and anxiety symptoms, current major depressive episode, quality of life and positive mental health post-treatment (3 months after baseline) and at follow-ups (6 and 12 months after baseline). Additional goals of this study are to identify groups for whom the intervention is particularly effective and to identify the therapeutic pathways that are vital in inducing clinical change. This will be done by analyzing if treatment response is moderated by demographics, personality, past major depressive episodes, important life events and chronically disease, and mediated by reminiscence functions, perceived control, automatic positive thoughts and meaning in life. Finally the cost-effectiveness of the intervention relative to care as usual will be assessed by computing incremental costs per case of depression and anxiety avoided (cost-effectiveness) and per quality adjusted life year (QALY) (cost utility). Discussion It is expected that both the life-review intervention and its evaluation will contribute to the existing body of knowledge in several ways. First, the intervention is unique in linking life-review with narrative therapy and in its focus on specific, positive memories. Second, the evaluation is likely to answer questions regarding the acceptability and cost-effectiveness of life-review that have not been addressed thoroughly until now. Positive results of this study will make available a new evidence-based intervention to improve public health among people of 55 years and over. Trial registration Nederlands Trial Register TC = 1860. PMID:19619284

Psychological impact of screening for type 2 diabetes: controlled trial and comparative study embedded in the ADDITION (Cambridge) randomised controlled trial.

PubMed

Eborall, Helen C; Griffin, Simon J; Prevost, A Toby; Kinmonth, Ann-Louise; French, David P; Sutton, Stephen

2007-09-08

To quantify the psychological impact of primary care based stepwise screening for type 2 diabetes. Controlled trial and comparative study embedded in a randomised controlled trial. 15 practices (10 screening, five control) in the ADDITION (Cambridge) trial in the east of England. 7380 adults (aged 40-69) in the top fourth for risk of having undiagnosed type 2 diabetes (6416 invited for screening, 964 controls). Invited for screening for type 2 diabetes or not invited (controls), incorporating a comparative study of subgroups of screening attenders. Attenders completed questionnaires after a random blood glucose test and at 3-6 months and 12-15 months later. Controls were sent questionnaires at corresponding time points. Non-attenders were sent questionnaires at 3-6 months and 12-15 months. State anxiety (Spielberger state anxiety inventory), anxiety and depression (hospital anxiety and depression scale), worry about diabetes, and self rated health. No significant differences were found between the screening and control participants at any time-for example, difference in means (95% confidence intervals) for state anxiety after the initial blood glucose test was -0.53, -2.60 to 1.54, at 3-6 months was 1.51 (-0.17 to 3.20), and at 12-15 months was 0.57, -1.11 to 2.24. After the initial test, compared with participants who screened negative, those who screened positive reported significantly poorer general health (difference in means -0.19, -0.25 to -0.13), higher state anxiety (0.93, -0.02 to 1.88), higher depression (0.32, 0.08 to 0.56), and higher worry about diabetes (0.25, 0.09 to 0.41), although effect sizes were small. Small but significant trends were found for self rated health across the screening subgroups at 3-6 months (P=0.047) and for worry about diabetes across the screen negative groups at 3-6 months and 12-15 months (P=0.001). Screening for type 2 diabetes has limited psychological impact on patients. Implementing a national screening programme based on the stepwise screening procedure used in the ADDITION (Cambridge) trial is unlikely to have significant consequences for patients' psychological health. Current Controlled Trials ISRCTN99175498 [controlled-trials.com].

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.

Informed community mobilization for dengue prevention in households with and without a regular water supply: Secondary analysis from the Camino Verde trial in Nicaragua.

PubMed

Cárcamo, Alvaro; Arosteguí, Jorge; Coloma, Josefina; Harris, Eva; Ledogar, Robert J; Andersson, Neil

2017-05-30

Studies in different countries have identified irregular water supply as a risk factor for dengue virus transmission. In 2013, Camino Verde, a cluster-randomised controlled trial in Managua, Nicaragua, and Mexico's Guerrero State, demonstrated impact of evidence-based community mobilisation on recent dengue infection and entomological indexes of infestation by Aedes aegypti mosquitoes. This secondary analysis of data from the trial impact survey asks: (1) what is the importance of regular water supply in neighbourhoods with and without the trial intervention and (2) can community interventions like Camino Verde reasonably exclude households with adequate water supply? Entomological data collected in the dry season of 2013 in intervention and control communities allow contrasts between households with regular and irregular water supplies. Indicators of entomological risk included the House Index and pupa positive household index. Generalised linear mixed models with cluster as a random effect compared households with and without regular water, and households in intervention and control communities. For the House Index, regular water supply was associated with a protection in both intervention households (OR 0.7, 95%CI 0.6-0.9) and control households (OR 0.6, 95%CI 0.5-0.8). For the pupa positive household index, we found a similar protection from regular water supply in intervention households (OR 0.6, 95%CI 0.4-0.8) and control households (OR 0.7, 95%CI 0.5-0.9). The Camino Verde intervention had a similar impact on House Index in households with regular water supply (OR 0.7, 95%CI 0.5-1.0) and irregular water supply (OR 0.6, 95%CI 0.4-0.8); for the pupa positive household index, the effect of the intervention was very similar in households with regular (OR0.5, 95%CI 0.3-0.8) and irregular (OR 0.5, 95%CI 0.3-0.9) water supply. While Aedes aegypti control efforts based on informed community mobilisation had a strong impact on households without a regular water supply, this intervention also impacted entomological indices in households with a regular water supply. These households should not be excluded from community mobilisation efforts to reduce the Aedes aegypti vector. ISRCTN27581154 .

Effectiveness of teaching cognitive-behavioral techniques on locus of control in hemodialysis patients

PubMed Central

Mehrtak, Mohammad; Habibzadeh, Shahram; Farzaneh, Esmaeil; Rjaei-Khiavi, Abdollah

2017-01-01

Background Many of the cognitive behavioral models and therapeutic protocols developed so far for psychological disorders and chronic diseases have proved effective through clinical research. Objective This study aimed to determine the effectiveness of teaching cognitive-behavioral techniques on locus of control in hemodialysis patients. Methods This controlled clinical trial study was conducted in 2015 with 76 patients selected by census and treated with a hemodialysis machine in the dialysis department of Vali-Asr Hospital in the city of Meshkinshahr. A total of four patients were excluded because of their critical conditions while the rest, who were recruited, were randomly divided into two equal groups of 36 patients as the intervention and control groups. First, the locus of control was measured in both groups through a pretest, and cognitive-behavioral techniques were then taught to the intervention group during eight 45 to 90-minute sessions. The locus of control in patients of both groups was finally re-measured through a posttest. Data were collected using Rotter’s Locus of Control Inventory. The Wilcoxon test and Mann–Whitney U test were respectively used in SPSS18 for data analysis. Results In the pretest and posttest stages respectively, 4.8% and 14.3% of samples in the control group as well as 14.3% and 33.3% of samples in the intervention group enjoyed internal locus of control. The difference between the pretest and posttest scores of internal locus of control in the intervention group was significant (p=0.004), which indicates the positive effect of cognitive-behavioral psychotherapeutic intervention on internalization of locus of control in this group. Conclusions Given the external locus of control in most of the study patients and also the positive significant effect of cognitive-behavioral psychotherapy on internalization of locus of control in this group of patients, it appears necessary to have a psychology resident present in the hemodialysis department to teach the necessary cognitive-behavioral techniques to internalize the locus of control. Trial registration The trial was registered at the Thai Clinical Trial Registry (http://www.clinicaltrials.in.th) with the TCTID: TCTR20170707003. Funding The authors received no financial support for the research, authorship, and/or publication of this article. PMID:29238508

Robust Encoding of Spatial Information in Orbitofrontal Cortex and Striatum.

PubMed

Yoo, Seng Bum Michael; Sleezer, Brianna J; Hayden, Benjamin Y

2018-06-01

Knowing whether core reward regions carry information about the positions of relevant objects is crucial for adjudicating between choice models. One limitation of previous studies, including our own, is that spatial positions can be consistently differentially associated with rewards, and thus position can be confounded with attention, motor plans, or target identity. We circumvented these problems by using a task in which value-and thus choices-was determined solely by a frequently changing rule, which was randomized relative to spatial position on each trial. We presented offers asynchronously, which allowed us to control for reward expectation, spatial attention, and motor plans in our analyses. We find robust encoding of the spatial position of both offers and choices in two core reward regions, orbitofrontal Area 13 and ventral striatum, as well as in dorsal striatum of macaques. The trial-by-trial correlation in noise in encoding of position was associated with variation in choice, an effect known as choice probability correlation, suggesting that the spatial encoding is associated with choice and is not incidental to it. Spatial information and reward information are not carried by separate sets of neurons, although the two forms of information are temporally dissociable. These results highlight the ubiquity of multiplexed information in association cortex and argue against the idea that these ostensible reward regions serve as part of a pure value domain.

Renal Vascular Clamp Placement: A Potential Cause of Incomplete Hilar Control during Partial Nephrectomy.

PubMed

Tryon, David; Myklak, Kristene; Alsyouf, Muhannad; Conceicao, Carol; Peplinski, Brandon; Arenas, Javier L; Faaborg, Daniel; Ruckle, Herbert C; Baldwin, D Duane

2016-03-01

Previous benchtop studies have shown that robotic bulldog clamps provide incomplete vascular control of a Penrose drain. We determined the efficacy of robotic and laparoscopic bulldog clamps to ensure hemostasis on the human renal artery. The effect of clamp position on vascular control was also examined. Fresh human cadaveric renal arteries were used to determine the leak point pressure of 7 bulldog clamps from a total of 3 manufacturers. Five trials were performed per clamp at 4 locations, including the fulcrum, proximal, middle and distal positions. Comparison was done using the Kruskal-Wallis test with p <0.05 considered significant. None of the bulldog clamps leaked at a pressure less than 215 mm Hg when applied at the proximal, middle or distal position. In general leak point pressure decreased as the artery was positioned more distal along the clamp. The exception was when the vessel was placed at the fulcrum position. At that position 80% to 100% of trials with the Klein laparoscopic, 100% with the Klein robotic (Klein Robotic, San Antonio, Texas) and 60% to 80% with the Scanlan robotic (Scanlan International, Saint Paul, Minnesota) clamp leaked at pressure below 215 mm Hg. Each vascular clamp adequately occluded flow at physiological pressure when placed at the proximal, middle or distal position. Furthermore, these results demonstrate that there is leakage at physiological pressure when the artery is placed at the fulcrum of certain clamp types. These results suggest that applying a bulldog clamp at the fulcrum could potentially lead to inadequate vessel occlusion and intraoperative bleeding. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain.

PubMed

Hausmann, Leslie R M; Ibrahim, Said A; Kwoh, C Kent; Youk, Ada; Obrosky, D Scott; Weiner, Debra K; Vina, Ernest; Gallagher, Rollin M; Mauro, Genna T; Parks, Acacia

2018-01-01

Knee osteoarthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield small to moderate improvements in pain and have not been effective at reducing racial disparities in the management of pain. The biopsychosocial model of pain and evidence from the positive psychology literature suggest that increasing positive psychological skills (e.g., gratitude, kindness) could improve pain and functioning and reduce disparities in osteoarthritis pain management. Activities to cultivate positive psychological skills have been developed and validated; however, they have not been tested in patients with osteoarthritis, their effects on racial differences in health outcomes have not been examined, and evidence of their effects on health outcomes in patients with other chronic illnesses is of limited quality. In this article we describe the rationale and design of Staying Positive with Arthritis (SPA) study, a randomized controlled trial in which 180 African American and 180 White primary care patients with chronic pain from knee osteoarthritis will be randomized to a 6-week program of either positive skill-building activities or neutral control activities. The primary outcomes will be self-reported pain and functioning as measured by the WOMAC Osteoarthritis Index. We will assess these primary outcomes and potential, exploratory psychosocial mediating variables at an in-person baseline visit and by telephone at 1, 3, and 6months following completion of the assigned program. If effective, the SPA program would be a novel, theoretically-informed psychosocial intervention to improve quality and equity of care in the management of chronic pain from osteoarthritis. Published by Elsevier Inc.

A benefit-finding intervention for family caregivers of persons with Alzheimer disease: study protocol of a randomized controlled trial

PubMed Central

2012-01-01

Background Caregivers of relatives with Alzheimer’s disease are highly stressed and at risk for physical and psychiatric conditions. Interventions are usually focused on providing caregivers with knowledge of dementia, skills, and/or support, to help them cope with the stress. This model, though true to a certain extent, ignores how caregiver stress is construed in the first place. Besides burden, caregivers also report rewards, uplifts, and gains, such as a sense of purpose and personal growth. Finding benefits through positive reappraisal may offset the effect of caregiving on caregiver outcomes. Design Two randomized controlled trials are planned. They are essentially the same except that Trial 1 is a cluster trial (that is, randomization based on groups of participants) whereas in Trial 2, randomization is based on individuals. Participants are randomized into three groups - benefit finding, psychoeducation, and simplified psychoeducation. Participants in each group receive a total of approximately 12 hours of training either in group or individually at home. Booster sessions are provided at around 14 months after the initial treatment. The primary outcomes are caregiver stress (subjective burden, role overload, and cortisol), perceived benefits, subjective health, psychological well-being, and depression. The secondary outcomes are caregiver coping, and behavioral problems and functional impairment of the care-recipient. Outcome measures are obtained at baseline, post-treatment (2 months), and 6, 12, 18 and 30 months. Discussion The emphasis on benefits, rather than losses and difficulties, provides a new dimension to the way interventions for caregivers can be conceptualized and delivered. By focusing on the positive, caregivers may be empowered to sustain caregiving efforts in the long term despite the day-to-day challenges. The two parallel trials will provide an assessment of whether the effectiveness of the intervention depends on the mode of delivery. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org/en/) identifier number ChiCTR-TRC-10000881. PMID:22747914

Art participation for psychosocial wellbeing during stroke rehabilitation: a feasibility randomised controlled trial.

PubMed

Morris, Jacqui H; Kelly, Chris; Joice, Sara; Kroll, Thilo; Mead, Gillian; Donnan, Peter; Toma, Madalina; Williams, Brian

2017-08-30

To examine the feasibility of undertaking a pragmatic single-blind randomised controlled trial (RCT) of a visual arts participation programme to evaluate effects on survivor wellbeing within stroke rehabilitation. Stroke survivors receiving in-patient rehabilitation were randomised to receive eight art participation sessions (n = 41) or usual care (n = 40). Recruitment, retention, preference for art participation and change in selected outcomes were evaluated at end of intervention outcome assessment and three-month follow-up. Of 315 potentially eligible participants 81 (29%) were recruited. 88% (n = 71) completed outcome and 77% (n = 62) follow-up assessments. Of eight intervention group non-completers, six had no preference for art participation. Outcome completion varied between 97% and 77%. Running groups was difficult because of randomisation timing. Effectiveness cannot be determined from this feasibility study but effects sizes suggested art participation may benefit emotional wellbeing, measured on the positive and negative affect schedule, and self-efficacy for Art (d = 0.24-0.42). Undertaking a RCT of art participation within stroke rehabilitation was feasible. Art participation may enhance self-efficacy and positively influence emotional wellbeing. These should be outcomes in a future definitive trial. A cluster RCT would ensure art groups could be reliably convened. Fewer measures, and better retention strategies are required. Implications for Rehabilitation This feasibility randomised controlled trial (RCT) showed that recruiting and retaining stroke survivors in an RCT of a visual arts participation intervention within stroke rehabilitation was feasible. Preference to participate in art activities may influence recruitment and drop-out rates, and should be addressed and evaluated fully. Art participation as part of rehabilitation may improve some aspects of post-stroke wellbeing, including positive affect and self-efficacy for art. A future definitive cluster RCT would facilitate full evaluation of the value art participation can add to rehabilitation.

Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya.

PubMed

Lowther, Keira; Harding, Richard; Ahmed, Aabid; Gikaara, Nancy; Ali, Zippy; Kariuki, Hellen; Sherr, Lorraine; Simms, Victoria; Selman, Lucy

2016-01-01

Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care. The implications of study participation on outcome data in such populations have been discussed theoretically, but rarely empirically examined. We aimed to explore the effects of participating in a randomised controlled trial conducted in an HIV clinic in Mombasa, Kenya. We report qualitative data from the Treatment Outcomes in Palliative Care trial, which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to standard care. Participants in both arms attended five monthly quantitative data collection appointments. Post-trial exit, 10 control and 20 intervention patients participated in semi-structured qualitative interviews, analysed using thematic analysis. We found benefit attributed to the compassion of the research team, social support, communication, completion of patient reported outcome measures (PROMs) and material support (transport reimbursement). Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team, which improved mental health and well-being. Open and non-judgmental communication made participants feel accepted. Participants described how repeated completion of the PROMs was a prompt for reflection, through which they began to help themselves and self-care. Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities, enhancing self-worth. These findings emphasise the importance of compassion, support and effective communication in the clinical encounter, particularly in stigmatised and isolated populations, and the potential of the integration of simple PROMs to improve patient outcomes. Participation in research has unexpected positive benefits for participants, which should be taken into account when designing research in similar populations. Researchers should be aware of the effects of financial reimbursement and contact with researchers in isolated and impoverished communities.

Pivotal factors concerned in design of acupuncture clinical research: From two articles in JAMA.

PubMed

Wu, Jia-Ni; Qin, Zong-Shi; Liu, Zhi-Shun

2017-11-01

Two randomized controlled trials of acupuncture concerning polycystic ovary syndrome (PCOS) and stress urinary incontinence (SUI) were published simultaneously in the 24th issue, 2017 of The Journal of the American Medical Association (JAMA). A trial involving PCOS indicated that active acupuncture did not increase live birth compared with sham acupuncture; meanwhile, another trial referring to SUI showed that electroacupuncture resulted in less urine leakage compared with sham electroacupuncture. With an eye to the negative and positive results of acupuncture, three pivotal factors should be contemplated: (1) proper illness for acupuncture, that is, a problem need to be solved in current medical science, and acupuncture may really work for it; (2) proper pre-studied primary outcome, which is better be objective and repeatedly measurable to reveal the therapeutic effect of acupuncture truly and objectively; (3) proper sham control, which can blind the patients to the upmost extent with minimal biological effects. Through the publication of clinical trials of acupuncture in high-impact journals in recent years, researchers should have confidence in their clinical trials by pondering over these three pivotal factors.

Can jurors recognize missing control groups, confounds, and experimenter bias in psychological science?

PubMed

McAuliff, Bradley D; Kovera, Margaret Bull; Nunez, Gabriel

2009-06-01

This study examined the ability of jury-eligible community members (N = 248) to detect internal validity threats in psychological science presented during a trial. Participants read a case summary in which an expert testified about a study that varied in internal validity (valid, missing control group, confound, and experimenter bias) and ecological validity (high, low). Ratings of expert evidence quality and expert credibility were higher for the valid versus missing control group versions only. Internal validity did not influence verdict or ratings of plaintiff credibility and no differences emerged as a function of ecological validity. Expert evidence quality, expert credibility, and plaintiff credibility were positively correlated with verdict. Implications for the scientific reasoning literature and for trials containing psychological science are discussed.

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

Luteinising hormone releasing hormone for incomplete descent of the testis.

PubMed

Klidjian, A M; Swift, P G; Johnstone, J M

1985-06-01

Forty boys with 54 incompletely descended testes took part in a double blind, controlled trial of intranasal luteinising hormone releasing hormone. In the control (placebo) group of 18 boys there was no significant change in testicular descent and all required orchidopexy; in the 22 treated boys, however, 12 of 29 testes (42%) were found in a lower position. This study supports the idea that a trial of intranasal luteinising hormone releasing hormone (1200 micrograms/day for 28 days) will help clarify the need for orchidopexy in at least 30% of boys with incomplete descent of the testis, particularly those in whom the testes have emerged from the inguinal canal.

Neural mechanisms of limb position estimation in the primate brain.

PubMed

Shi, Ying; Buneo, Christopher A

2011-01-01

Understanding the neural mechanisms of limb position estimation is important both for comprehending the neural control of goal directed arm movements and for developing neuroprosthetic systems designed to replace lost limb function. Here we examined the role of area 5 of the posterior parietal cortex in estimating limb position based on visual and somatic (proprioceptive, efference copy) signals. Single unit recordings were obtained as monkeys reached to visual targets presented in a semi-immersive virtual reality environment. On half of the trials animals were required to maintain their limb position at these targets while receiving both visual and non-visual feedback of their arm position, while on the other trials visual feedback was withheld. When examined individually, many area 5 neurons were tuned to the position of the limb in the workspace but very few neurons modulated their firing rates based on the presence/absence of visual feedback. At the population level however decoding of limb position was somewhat more accurate when visual feedback was provided. These findings support a role for area 5 in limb position estimation but also suggest that visual signals regarding limb position are only weakly represented in this area, and only at the population level.

Lifestyle interventions to improve the quality of life of men with prostate cancer: A systematic review of randomized controlled trials.

PubMed

Menichetti, Julia; Villa, Silvia; Magnani, Tiziana; Avuzzi, Barbara; Bosetti, Davide; Marenghi, Cristina; Morlino, Sara; Rancati, Tiziana; Van Poppel, Hein; Salvioni, Roberto; Valdagni, Riccardo; Bellardita, Lara

2016-12-01

Improving quality of life is a key issue for patients with prostate cancer (PCa). Lifestyle interventions could positively impact the quality of life of patients. However, there is no clear-cut understanding of the role of diet, exercise and risky behaviour reduction in improving the quality of life of men with PCa. The aim of this review was to systematically summarize randomized controlled trials on lifestyle in PCa patients with quality of life as main outcome. 17 trials were included. Most of them referred to exercise interventions (71%) and involved men undergoing androgen deprivation therapy (47%). Exercise studies yielded the greater amount of positive results on quality of life outcomes (67%), followed by dietary interventions (50%) and combined lifestyle interventions (33%). In particular, supervised exercise programs with resistance training sessions were the ones producing greater convincing evidence for benefits on quality of life. Further studies with high methodological quality providing adequate information to develop evidence-based, personalized lifestyle interventions that can effectively ameliorate PCa-related quality of life are needed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Cocoa polyphenols enhance positive mood states but not cognitive performance: a randomized, placebo-controlled trial.

PubMed

Pase, Matthew P; Scholey, Andrew B; Pipingas, Andrew; Kras, Marni; Nolidin, Karen; Gibbs, Amy; Wesnes, Keith; Stough, Con

2013-05-01

This study aimed to examine the acute and sub-chronic effects of cocoa polyphenols on cognition and mood. In a randomized, double-blind study, healthy middle-aged participants received a dark chocolate drink mix standardized to contain 500 mg, 250 mg or 0 mg of polyphenols (placebo) in a parallel-groups design. Participants consumed their assigned treatment once daily for 30 days. Cognition was measured with the Cognitive Drug Research system and self-rated mood with the Bond-Lader Visual Analogue Scale. Participants were tested at baseline, at 1, 2.5 and 4 h after a single acute dose and again after receiving 30 days of treatment. In total, 72 participants completed the trial. After 30 days, the high dose of treatment significantly increased self-rated calmness and contentedness relative to placebo. Mood was unchanged by treatment acutely while cognition was unaffected by treatment at all time points. This randomized controlled trial is perhaps the first to demonstrate the positive effects of cocoa polyphenols on mood in healthy participants. This provides a rationale for exploring whether cocoa polyphenols can ameliorate the symptoms associated with clinical anxiety or depression.

Collaborative ring-trial of Dynabeads anti-Salmonella for immunomagnetic separation of stressed Salmonella cells from herbs and spices.

PubMed

Mansfield, L; Forsythe, S

1996-02-01

Eight laboratories participated in a Salmonella detection ring-trial which compared selective enrichment by conventional broths with immunomagnetic separation (IMS) using Dynabeads Anti-Salmonella. Laboratories analyzed six types of herbs and spices that were spiked with one of six freeze-dried Salmonella species. Each herb and spice analysis comprised of 12 samples (25 g each) which had been spiked at three different levels, plus a negative control and stored for one week prior to testing. Out of a total 468 samples analyzed, 195 (41.7%) were positive by both methods. Eighteen samples were positive only by IMS enrichment, in comparison with 19 positive samples by conventional enrichment broths and not IMS. These results confirm the potential use of IMS as an alternative to enrichment broths for Salmonella isolation.

A review of escitalopram and citalopram in child and adolescent depression.

PubMed

Carandang, Carlo; Jabbal, Rekha; Macbride, Angela; Elbe, Dean

2011-11-01

To review the basic pharmacology and published literature regarding escitalopram and citalopram in child and adolescent depression. A LITERATURE REVIEW WAS CONDUCTED USING THE SEARCH TERMS: 'escitalopram', 'citalopram', 'depression', 'randomized controlled trial', 'open label trial' and limits set to: Human trials, English Language and All Child (Age 0-18). Additional articles were identified from reference information and poster presentation data. Three prospective, randomized controlled trials (RCT) were found for escitalopram in pediatric depression, and two RCTs were found for citalopram. One RCT each for escitalopram and citalopram showed superiority over placebo on the primary out come measure. Adverse effects in escitalopram and citalopram trials were generally mild to moderate. Suicidality was not assessed systematically in all RCTs reviewed, but did not appear to be elevated over placebo in escitalopram RCTs. One trial reported numerically higher suicide related events for citalopram compared to placebo (14 vs. 5, p=0.06). At present, escitalopram and citalopram should be considered a second-line option for adolescent depression. The US Food and Drug Administration approval of escitalopram for treatment of adolescent depression was based on a single positive RCT. This is less evidence than typically required for approval of a drug for a new indication.

A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults.

PubMed

Garofalo, Robert; Kuhns, Lisa M; Hotton, Anna; Johnson, Amy; Muldoon, Abigail; Rice, Dion

2016-05-01

HIV-positive adolescents and young adults often experience suboptimal medication adherence, yet few interventions to improve adherence in this group have shown evidence of efficacy. We conducted a randomized trial of a two-way, personalized daily text messaging intervention to improve adherence to antiretroviral therapy (ART) among N = 105 poorly adherent HIV-positive adolescents and young adults, ages 16-29. Adherence to ART was assessed via self-reported visual analogue scale (VAS; 0-100 %) at 3 and 6-months for mean adherence level and proportion ≥90 % adherent. The average effect estimate over the 6-month intervention period was significant for ≥90 % adherence (OR = 2.12, 95 % CI 1.01-4.45, p < .05) and maintained at 12-months (6 months post-intervention). Satisfaction scores for the intervention were very high. These results suggest both feasibility and initial efficacy of this approach. Given study limitations, additional testing of this intervention as part of a larger clinical trial with objective and/or clinical outcome measures of adherence is warranted.

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

PubMed

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

2016-05-01

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

Mindfulness Training Increases Momentary Positive Emotions and Reward Experience in Adults Vulnerable to Depression: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Geschwind, Nicole; Peeters, Frenk; Drukker, Marjan; van Os, Jim; Wichers, Marieke

2011-01-01

Objective: To examine whether mindfulness-based cognitive therapy (MBCT) increases momentary positive emotions and the ability to make use of natural rewards in daily life. Method: Adults with a life-time history of depression and current residual depressive symptoms (mean age = 43.9 years, SD = 9.6; 75% female; all Caucasian) were randomized to…

A Family Focused Randomized Controlled Trial to Prevent Adolescent Alcohol and Tobacco Use: The Moderating Roles of Positive Parenting and Adolescent Gender

ERIC Educational Resources Information Center

Jones, Deborah J.; Olson, Ardis L.; Forehand, Rex; Gaffney, Cecelia A.; Zens, Michael S.; Bau, J. J.

2005-01-01

Four years of longitudinal data from 2,153 families with a 5th- or 6th-grade preadolescent participating in a family-focused pediatric primary-care-based prevention program were used to examine whether prevention effects were moderated by positive parenting and/or adolescent gender. Alcohol and tobacco use, internalizing problems, and…

Drawing on Resilience: Piloting the Utility of the Kinetic Family Drawing to Measure Resilience in Children of HIV-Positive Mothers

ERIC Educational Resources Information Center

Ebersöhn, L.; Eloff, I.; Finestone, M.; van Dullemen, I.; Sikkema, K.; Forsyth, B.

2012-01-01

In this article we describe how using a visual, child-friendly measure of resilience in a randomised control trial (RCT), the Kgolo Mmogo (KM) project, resulted in representative insights on resilience in a mother-child relationship where the mother is HIV-positive. We used the existing psychological method Kinetic Family Drawing (KFD) to measure…

Correcting for multiple-testing in multi-arm trials: is it necessary and is it done?

PubMed

Wason, James M S; Stecher, Lynne; Mander, Adrian P

2014-09-17

Multi-arm trials enable the evaluation of multiple treatments within a single trial. They provide a way of substantially increasing the efficiency of the clinical development process. However, since multi-arm trials test multiple hypotheses, some regulators require that a statistical correction be made to control the chance of making a type-1 error (false-positive). Several conflicting viewpoints are expressed in the literature regarding the circumstances in which a multiple-testing correction should be used. In this article we discuss these conflicting viewpoints and review the frequency with which correction methods are currently used in practice. We identified all multi-arm clinical trials published in 2012 by four major medical journals. Summary data on several aspects of the trial design were extracted, including whether the trial was exploratory or confirmatory, whether a multiple-testing correction was applied and, if one was used, what type it was. We found that almost half (49%) of published multi-arm trials report using a multiple-testing correction. The percentage that corrected was higher for trials in which the experimental arms included multiple doses or regimens of the same treatments (67%). The percentage that corrected was higher in exploratory than confirmatory trials, although this is explained by a greater proportion of exploratory trials testing multiple doses and regimens of the same treatment. A sizeable proportion of published multi-arm trials do not correct for multiple-testing. Clearer guidance about whether multiple-testing correction is needed for multi-arm trials that test separate treatments against a common control group is required.

B-cell-targeted therapies in systemic lupus erythematosus and ANCA-associated vasculitis: current progress.

PubMed

Md Yusof, Md Yuzaiful; Vital, Edward M J; Emery, Paul

2013-08-01

B cells play a central role in the pathogenesis of systemic lupus erythematosus and anti-neutrophil cytoplasmic antibody-associated vasculitis. There are various strategies for targeting B cells including depletion, inhibition of survival factors, activation and inhibition of co-stimulatory molecules. Controlled trials in systemic lupus erythematosus have shown positive results for belimumab, promising results for epratuzumab and negative results for rituximab. The failure of rituximab in controlled trials has been attributed to trial design, sample size and outcome measures rather than true inefficacy. In anti-neutrophil cytoplasmic antibody-associated vasculitis, rituximab is effective for remission induction and in relapsing disease. However, the optimal long-term re-treatment strategy remains to be determined. Over the next 5 years, evidence will be available regarding the clinical efficacy of these novel therapies, biomarkers and their long-term safety.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

PubMed

Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

2016-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

Transverse occiput position: Using manual Rotation to aid Normal birth and improve delivery OUTcomes (TURN-OUT): A study protocol for a randomised controlled trial.

PubMed

de Vries, Bradley; Phipps, Hala; Kuah, Sabrina; Pardey, John; Ludlow, Joanne; Bisits, Andrew; Park, Felicity; Kowalski, David; Hyett, Jon A

2015-08-18

Fetal occiput transverse position in the form of deep transverse arrest has long been associated with caesarean section and instrumental vaginal delivery. Occiput transverse position incidentally found in the second stage of labour is also associated with operative delivery in high risk cohorts. There is evidence from cohort studies that prophylactic manual rotation reduces the caesarean section rate. This is a protocol for a double blind, multicentre, randomised, controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate. Eligible participants will be ≥37 weeks pregnant, with a singleton pregnancy, and a cephalic presentation in the occiput transverse position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 49%, for a reduction to 35%, an alpha value of 0.05 and a beta value of 0.2, 416 participants will need to be enrolled. Participants will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery. Secondary outcomes will be caesarean section, significant maternal mortality and morbidity, and significant perinatal mortality and morbidity. Analysis will be on an intention-to-treat basis. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, (protocol number: X110410). This trial addresses an important clinical question concerning a commonly used procedure which has the potential to reduce operative delivery and its associated complications. Some issues discussed in the protocol include methods of assessing risk of bias due to inadequate masking of a procedural interventions, variations in intervention efficacy due to operator experience and the recruitment difficulties associated with intrapartum studies. This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005752 ) on 4 January 2013.

Impact of patient position on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials.

PubMed

Alexiou, Vangelis G; Ierodiakonou, Vrettos; Dimopoulos, George; Falagas, Matthew E

2009-12-01

The aim of this study is to summarize the effect of position (prone and semirecumbent 45 degrees ) of mechanically ventilated patients on the incidence of ventilator-associated pneumonia (VAP) and other outcomes. A systematic search for randomized control trials (RCTs) was done. We estimated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using fixed effects model or random effects model, where appropriate. For continuous variables, we calculated the estimation of weighted mean differences. We analyzed data extracted from 3 RCTs studying the semirecumbent 45 degrees and 4 RCTs studying the prone position with a total of 337 and 1018 patients, respectively. The odds of developing clinically diagnosed VAP were significantly lower among patients in the semirecumbent 45 degrees position compared to patients in the supine position (OR = 0.47; 95% CI, 0.27-0.82; 337 patients). The comparison of prone vs supine position group showed a moderate trend toward better outcomes regarding the incidence of clinically diagnosed VAP among patients in the prone position (OR = 0.80; 95% CI, 0.60-1.08; 1018 patients). The subanalysis regarding the incidence of microbiologically documented VAP, the length of intensive care unit stay, and the duration of mechanical ventilation showed that patients in the semirecumbent 45 degrees position have a moderate trend toward better clinical outcomes. This meta-analysis provides additional evidence that the usual practice of back-rest elevation of 15 degrees to 30 degrees is not sufficient to prevent VAP in mechanically ventilated patients. Patients positioned semirecumbently 45 degrees have significantly lower incidence of clinically diagnosed VAP compared to patients positioned supinely. On the other hand, the incidence of clinically diagnosed VAP among patients positioned pronely does not differ significantly from the incidence of clinically diagnosed VAP among patients positioned supinely.

Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache.

PubMed

Fernández-de-las-Peñas, César; Alonso-Blanco, Cristina; San-Roman, Jesús; Miangolarra-Page, Juan C

2006-03-01

Literature review of quality of clinical trials. To determine the methodological quality of published randomized controlled trials that used spinal manipulation and/or mobilization to treat patients with tension-type headache (TTH), cervicogenic headache (CeH), and migraine (M) in the last decade. TTH, CeH, and M are the most prevalent types of headaches seen in adults. Individuals who have headaches frequently use physical therapy, manual therapy, or chiropractic care. Randomized controlled trials are considered an optimal method with which to assess the efficacy of any intervention. Computerized literature searches were performed in MEDLINE, EMBASE, COCHRANE, AMED, MANTIS, CINHAL, and PEDro databases. Randomized controlled trials in which spinal manipulation and/or mobilization had been used for TTH, CeH, and M published in a peer-reviewed journal as full text, and with at least 1 clinically relevant outcome measure (ie, headache intensity, duration, or frequency) were reviewed. The methodological quality of the studies was assessed independently by 2 reviewers using a set of predefined criteria. Only 8 studies met all the inclusion criteria. One clinical trial evaluated spinal manipulation and mobilization together, and the remaining 7 assessed spinal manipulative therapy. No controlled trials analyzing exclusively the effects of spinal mobilization were found. Methodological scores ranged from 35 to 56 points out of a theoretical maximum of 100 points, indicating an overall poor methodology of the studies. Only 2 studies obtained a high-quality score (greater than 50 points). No significant differences in quality scores were found based on the type of headache investigated. Methodological quality was not associated with the year of publication (before 2000, or later) nor with the results (positive, neutral, negative) reported in the studies. The most common flaws were a small sample size, the absence of a placebo control group, lack of blinded patients, and no description of the manipulative procedure. There are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders.

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot).

PubMed

Olavarría, Verónica V; Arima, Hisatomi; Anderson, Craig S; Brunser, Alejandro; Muñoz-Venturelli, Paula; Billot, Laurent; Lavados, Pablo M

2017-02-01

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

Defining pollen exposure times for clinical trials of allergen immunotherapy for pollen-induced rhinoconjunctivitis - an EAACI position paper.

PubMed

Pfaar, O; Bastl, K; Berger, U; Buters, J; Calderon, M A; Clot, B; Darsow, U; Demoly, P; Durham, S R; Galán, C; Gehrig, R; Gerth van Wijk, R; Jacobsen, L; Klimek, L; Sofiev, M; Thibaudon, M; Bergmann, K C

2017-05-01

Clinical efficacy of pollen allergen immunotherapy (AIT) has been broadly documented in randomized controlled trials. The underlying clinical endpoints are analysed in seasonal time periods predefined based on the background pollen concentration. However, any validated or generally accepted definition from academia or regulatory authorities for this relevant pollen exposure intensity or period of time (season) is currently not available. Therefore, this Task Force initiative of the European Academy of Allergy and Clinical Immunology (EAACI) aimed to propose definitions based on expert consensus. A Task Force of the Immunotherapy and Aerobiology and Pollution Interest Groups of the EAACI reviewed the literature on pollen exposure in the context of defining relevant time intervals for evaluation of efficacy in AIT trials. Underlying principles in measuring pollen exposure and associated methodological problems and limitations were considered to achieve a consensus. The Task Force achieved a comprehensive position in defining pollen exposure times for different pollen types. Definitions are presented for 'pollen season', 'high pollen season' (or 'peak pollen period') and 'high pollen days'. This EAACI position paper provides definitions of pollen exposures for different pollen types for use in AIT trials. Their validity as standards remains to be tested in future studies. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

PubMed Central

Jacobsen, Paul B.; Wells, Kristen J.; Meade, Cathy D.; Quinn, Gwendolyn P.; Lee, Ji-Hyun; Fulp, William J.; Gray, Jhanelle E.; Baz, Rachid C.; Springett, Gregory M.; Levine, Richard M.; Markham, Merry-Jennifer; Schreiber, Fred J.; Cartwright, Thomas H.; Burke, James M.; Siegel, Robert D.; Malafa, Mokenge P.; Sullivan, Daniel

2012-01-01

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials. PMID:22614993

Do children with reading delay benefit from the use of personal FM systems in the classroom?

PubMed

Purdy, Suzanne C; Smart, Jennifer L; Baily, Melissa; Sharma, Mridula

2009-12-01

FM systems have been used to compensate for poor signal-to-noise ratios in classrooms. This study evaluates benefits of a 6-week trial of personal FM systems used during the school day for children with reading delay aged 6-11 years, using a randomized control design. Teachers and children completed the LIFE-UK questionnaire. Test-retest reliability of the LIFE-UK children's version was confirmed in a separate group of 18 children from the same school. The 23 children in the FM group had significantly improved teacher ratings, and the children's ratings of classroom listening for difficult situations were significantly better after the trial. These changes did not occur for the 23 control-group children. Most children (92%) commented positively about the FM after the trial. It is likely that a longer FM trial or a specific reading intervention combined with FM will be required for the benefits of enhanced listening to affect performance on standardized reading tests.

Neck muscle fatigue differentially alters scapular and humeral kinematics during humeral elevation in subclinical neck pain participants versus healthy controls.

PubMed

Zabihhosseinian, Mahboobeh; Holmes, Michael W R; Howarth, Samuel; Ferguson, Brad; Murphy, Bernadette

2017-04-01

Scapular orientation is highly dependent on axioscapular muscle function. This study examined the impact of neck muscle fatigue on scapular and humeral kinematics in participants with and without subclinical neck pain (SCNP) during humeral elevation. Ten SCNP and 10 control participants performed three unconstrained trials of dominant arm humeral elevation in the scapular plane to approximately 120 degrees before and after neck extensor muscle fatigue. Three-dimensional scapular and humeral kinematics were measured during the humeral elevation trials. Humeral elevation plane angle showed a significant interaction between groups (SCNP vs controls) and trial (pre- vs post-fatigue) (p=0.001). Controls began the unconstrained humeral elevation task after fatigue in a more abducted position, (p=0.002). Significant baseline differences in scapular rotation existed between the two groups (Posterior/Anterior tilt, p=0.04; Internal/External Rotation, p=0.001). SCNP contributed to altered scapular kinematics. Neck muscle fatigue influenced humeral kinematics in controls but not the SCNP group; suggesting that altered scapular motor control in the SCNP group resulted in an impaired adaption further to the neck muscle fatigue. Copyright © 2017 Elsevier Ltd. All rights reserved.

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

PubMed

Peterson, Arthur V; Marek, Patrick M; Kealey, Kathleen A; Bricker, Jonathan B; Ludman, Evette J; Heffner, Jaimee L

2016-01-01

The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long-term into young adulthood. In light of the positive short-term effectiveness consistently observed from this and other trials for teen smokers, together with the lack of evidence from this study that such short-term impact can endure into young adulthood, sustained interventions that continue into young adulthood should be developed and tested for long-term impact. ClinicalTrials.gov NCT00115882.

Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

PubMed

Wang, Sophia; Hammes, Jessica; Khan, Sikandar; Gao, Sujuan; Harrawood, Amanda; Martinez, Stephanie; Moser, Lyndsi; Perkins, Anthony; Unverzagt, Frederick W; Clark, Daniel O; Boustani, Malaz; Khan, Babar

2018-03-27

Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action. ClinicalTrials.gov, NCT03095417 . Registered on 23 March 2017. Last updated on 15 May 2017.

Chinese herbal medicine for diabetic peripheral neuropathy.

PubMed

Chen, Wei; Zhang, Yin; Liu, Jian Ping

2011-06-15

Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy. To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy. We searched the Cochrane Neuromuscular Disease Group Specialized Register (15 June 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2010 in The Cochrane Library), MEDLINE (January 1966 to June 2010), EMBASE (January 1980 to June 2010), AMED (January 1985 to June 2010), Chinese Biomedical Database (CBM) (1979 to June 2010), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to June 2010), and VIP Chinese Science and Technique Journals Database (1989 to June 2010). We searched for unpublished literature in the Chinese Conference Papers Database and Chinese Dissertation Database (from inception to March 2010). No language or publication restrictions were used. We included randomized controlled trials of Chinese herbal medicine (with a minimum of four weeks treatment duration) for people with diabetic peripheral neuropathy compared with placebo, no intervention, or conventional interventions. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information. The data analyses were carried out using Review Manager 5.1 (Cochrane software). Thirty-nine randomized trials involving 2890 participants were included. All trials were conducted and published in China. Thirty different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 18 self-concocted Chinese herbal compound prescriptions. The trials reported on global symptom improvement (including improvement in numbness or pain) and changes in nerve conduction velocity. There was inadequate reporting on adverse events in the included trials. Most of the trials did not mention whether they monitored adverse effects at all. Only two trials reported adverse events: one occurred in the control group in one trial and in which group was unclear in the other trial . Conclusions cannot be drawn from this review about the safety of herbal medicines due to inadequate reporting. Most of the trials were of low methodological quality and therefore the interpretation of any positive findings for the efficacy of the included Chinese herbal medicines for treating diabetic peripheral neuropathy should be made with caution. Based on this systematic review, there is no evidence to support the objective effectiveness and safety of Chinese herbal medicines for diabetic peripheral neuropathy. No well designed, randomized placebo controlled trial with objective outcome measures has been conducted.

Triple p-positive parenting program for mothers of ADHD children.

PubMed

Aghebati, Asma; Gharraee, Banafsheh; Hakim Shoshtari, Mitra; Gohari, Mahmood Reza

2014-01-01

Attention deficit hyperactivity disorder (ADHD) is a chronic, highly prevalent neurodevelopmental disorder which affects 9% of school-age children. Triple P-Positive Parenting Program is an evidence-based parenting program reported to be useful in the management of this disorder. The aim of this randomized controlled trial was to evaluate the effectiveness of Triple P in mothers of ADHD children. In this study, 30 mothers with ADHD children aged between 6 to 10 were randomly assigned to two groups (15 participants in each group). Parenting style, mother-child relationship, maternal depression, anxiety and stress, and children's behavioral problems were evaluated. The intervention group received 120 minute sessions for 5 weeks and 15-30 minute telephone contacts for 3 weeks while no intervention was done for the control group. Analysis of covariance revealed that mothers of the Triple P group showed significant (p < 0.01) improvements in parenting style, mother-child relationship, and considerable decrease in depression, anxiety and stress. Women trained in the Triple P group also reported significantly lower rates of child misbehavior than women of the control group. Triple P-Positive Parenting intervention is effective and acceptable for mothers of ADHD children. None. Clinical Trial Registration-URL: http://www.irct.ir. Unique identifier: IRCT201111288234N1.

External cephalic version facilitation for breech presentation at term.

PubMed

Hofmeyr, G J

2001-01-01

Tocolytic drugs to relax the uterus as well as other methods have been also used in an attempt to facilitate external cephalic version at term. The objective of this review is to assess the effects of routine tocolysis, fetal acoustic stimulation, epidural or spinal analgesia and transabdominal amnioinfusion for external cephalic version at term on successful version and measures of pregnancy outcome. The Cochrane Pregnancy and Childbirth Group Trials Register and the Cochrane Controlled Trials Register were searched. Date of last search: April 2001. Randomised and quasi-randomised trials comparing routine versus selective tocolysis; fetal acoustic stimulation in midline fetal spine positions versus dummy or no stimulation; epidural or spinal analgesia versus no regional analgesia; or transabdominal amnioinfusion versus no amnioinfusion for external cephalic version at term. Eligibility and trial quality were assessed by the reviewer. In seven trials, routine tocolysis was associated with fewer failures of external cephalic version (relative risk 0.74, 95% confidence interval 0.64 to 0.87). There were no significant differences between non-cephalic presentations at birth. Caesarean sections were reduced (relative risk 0.85, confidence interval 0.72-0.99). Fetal acoustic stimulation in midline fetal spine positions was associated with fewer failures of external cephalic version at term (relative risk 0.17, 95% confidence interval 0.05 to 0.60). With epidural or spinal analgesia, external cephalic version failure, non-cephalic births and caesarean sections were reduced in one trial but not the other. The overall differences were not statistically significant. No randomised trials of transabdominal amnioinfusion for external cephalic version at term were located. Routine tocolysis appears to reduce the failure rate of external cephalic version at term. Although promising, there is not enough evidence to evaluate the use of fetal acoustic stimulation in midline fetal spine positions, nor of epidural or spinal analgesia. Large volume intravenous preloading may have contributed to the effectiveness demonstrated in one of the latter trials. No randomised trials of transabdominal amnioinfusion for external cephalic version at term were found.

A school-based program for control of group a streptococcal upper respiratory tract infections: a controlled trial in Southern China.

PubMed

Lin, Shuguang; Kaplan, Edward L; Rao, Xuxu; Johnson, Dwight R; Deng, Mulan; Zhuo, Qiling; Yang, Pingzhen; Mai, Jinzhuang; Dong, Taiming; Liu, Xiaoqing

2008-08-01

A prospective, school-based study included daily monitoring for incidence of symptomatic streptococcal-associated pharyngitis and monthly determinations of group A streptococcal prevalence. A treatment group received penicillin/erythromycin therapy at school for positive throat cultures; the control group sought medical care from their regular provider. Prevalence and incidence of group A streptococcal pharyngitis were significantly lower among the treatment group than in the controls.

Mind-body interventions during pregnancy for preventing or treating women's anxiety.

PubMed

Marc, Isabelle; Toureche, Narimane; Ernst, Edzard; Hodnett, Ellen D; Blanchet, Claudine; Dodin, Sylvie; Njoya, Merlin M

2011-07-06

Anxiety during pregnancy is a common problem. Anxiety and stress could have consequences on the course of the pregnancy and the later development of the child. Anxiety responds well to treatments such as cognitive behavioral therapy and/or medication. Non-pharmacological interventions such as mind-body interventions, known to decrease anxiety in several clinical situations, might be offered for treating and preventing anxiety during pregnancy. To assess the benefits of mind-body interventions during pregnancy in preventing or treating women's anxiety and in influencing perinatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2010), MEDLINE (1950 to 30 November 2010), EMBASE (1974 to 30 November 2010), the National Center for Complementary and Alternative Medicine (NCCAM) (1 December 2010), ClinicalTrials.gov (December 2010) and Current Controlled Trials (1 December 2010), searched the reference lists of selected studies and contacted professionals and authors in the field. Randomized controlled trials, involving pregnant women of any age at any time from conception to one month after birth, comparing mind-body interventions with a control group. Mind-body interventions include: autogenic training, biofeedback, hypnotherapy, imagery, meditation, prayer, auto-suggestion, tai-chi and yoga. Control group includes: standard care, other pharmacological or non-pharmacological interventions, other types of mind-body interventions or no treatment at all. Three review authors independently assessed trials for inclusion all assessed risk of bias for each included study. We extracted data independently using an agreed form and checked it for accuracy. We included eight trials (556 participants), evaluating hypnotherapy (one trial), imagery (five trials), autogenic training (one trial) and yoga (one trial). Due to the small number of studies per intervention and to the diversity of outcome measurements, we performed no meta-analysis, and have reported results individually for each study. Compared with usual care, in one study (133 women), imagery may have a positive effect on anxiety during labor decreasing anxiety at the early and middle stages of labor (MD -1.46; 95% CI -2.43 to -0.49; one study, 133 women) and (MD -1.24; 95% CI -2.18 to -0.30). Another study showed that imagery had a positive effect on anxiety and depression in the immediate postpartum period. Autogenic training might be effective for decreasing women's anxiety before delivering. Mind-body interventions might benefit women's anxiety during pregnancy. Based on individual studies, there is some but no strong evidence for the effectiveness of mind-body interventions for the management of anxiety during pregnancy. The main limitations of the studies were the lack of blinding and insufficient details on the methods used for randomization.

Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study.

PubMed

Locatelli, Francesco; Aljama, Pedro; Canaud, Bernard; Covic, Adrian; De Francisco, Angel; Macdougall, Iain C; Wiecek, Andrzej; Vanholder, Raymond

2010-09-01

The European Renal Best Practice (ERBP), which are issued by ERA-EDTA, are suggestions for clinical practice in areas in which evidence is lacking or weak, together with position statements on recently published randomized controlled trials, or on existing guidelines and recommendations. In 2009, the Anaemia Working Group of ERBP published its first position statement about the haemoglobin target to aim for with erythropoietin-stimulating agents (ESA) and on issues that were not covered by K-DOQI in 2006-07. This second position paper of the group follows the publication of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Study. This multi-centre, placebo-controlled trial compared cardiovascular and renal outcomes in 4038 patients with type 2 diabetes, chronic kidney disease not on dialysis, and anaemia who were randomized to complete anaemia correction (haemoglobin target of 13 g/dL using darbepoetin alpha) or placebo (with a haemoglobin rescue value of 9 g/dL). Following the findings of the TREAT study, the Anaemia Working Group of ERBP maintains its view that 'Hb values of 11-12 g/dL should be generally sought in the CKD population without intentionally exceeding 13 g/dL' and that the doses of ESA therapy to achieve the target haemoglobin should also be considered. More caution is suggested when treating anaemia with ESA therapy in patients with type 2 diabetes not undergoing dialysis (and probably in diabetics at all CKD stages). In those with ischaemic heart disease or with a previous history of stroke, possible benefits should be weighed up against an increased risk of stroke recurrence, when deciding which Hb level to aim for. These recommendations are not intended to represent a new guideline as they are not the result of a systematic review of the evidence.

Closing the Achievement Gap through Modification of Neurocognitive and Neuroendocrine Function: Results from a Cluster Randomized Controlled Trial of an Innovative Approach to the Education of Children in Kindergarten

PubMed Central

Blair, Clancy; Raver, C. Cybele

2014-01-01

Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children’s engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap. PMID:25389751

Closing the achievement gap through modification of neurocognitive and neuroendocrine function: results from a cluster randomized controlled trial of an innovative approach to the education of children in kindergarten.

PubMed

Blair, Clancy; Raver, C Cybele

2014-01-01

Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children's engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap.

A systematic review of randomized controlled trials of mHealth interventions against non-communicable diseases in developing countries.

PubMed

Stephani, Victor; Opoku, Daniel; Quentin, Wilm

2016-07-15

The reasons of deaths in developing countries are shifting from communicable diseases towards non-communicable diseases (NCDs). At the same time the number of health care interventions using mobile phones (mHealth interventions) is growing rapidly. We review studies assessing the health-related impacts of mHealth on NCDs in low- and middle-income countries (LAMICs). A systematic literature search of three major databases was performed in order to identify randomized controlled trials (RCTs) of mHealth interventions. Identified studies were reviewed concerning key characteristics of the trial and the intervention; and the relationship between intervention characteristics and outcomes was qualitatively assessed. The search algorithms retrieved 994 titles. 8 RCTs were included in the review, including a total of 4375 participants. Trials took place mostly in urban areas, tested different interventions (ranging from health promotion over appointment reminders and medication adjustments to clinical decision support systems), and included patients with different diseases (diabetes, asthma, hypertension). Except for one study all showed rather positive effects of mHealth interventions on reported outcome measures. Furthermore, our results suggest that particular types of mHealth interventions that were found to have positive effects on patients with communicable diseases and for improving maternal care are likely to be effective also for NCDs. Despite rather positive results of included RCTs, a firm conclusion about the effectiveness of mHealth interventions against NCDs is not yet possible because of the limited number of studies, the heterogeneity of evaluated mHealth interventions and the wide variety of reported outcome measures. More research is needed to better understand the specific effects of different types of mHealth interventions on different types of patients with NCDs in LaMICs.

An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and growth restriction (TEST): Trial protocol.

PubMed

Mone, Fionnuala; Mulcahy, Cecilia; McParland, Peter; Stanton, Alice; Culliton, Marie; Downey, Paul; McCormack, Dorothy; Tully, Elizabeth; Dicker, Patrick; Breathnach, Fionnuala; Malone, Fergal D; McAuliffe, Fionnuala M

2016-07-01

Pre-eclampsia remains a worldwide cause of maternal and perinatal morbidity and mortality. Low dose aspirin (LDA) can reduce the occurrence of pre-eclampsia in women with identifiable risk factors. Emerging screening tests can determine the maternal risk of developing placental disease, such as pre-eclampsia from the first trimester of pregnancy. The aim of this study is to determine if it is more beneficial in terms of efficacy and acceptability to routinely prescribe LDA to nulliparous low-risk women compared to test indicated LDA on the basis of a positive screening test for placental disease. We propose a three armed multi-center open-labeled randomized control trial of; (i) routine LDA, (ii) no aspirin, and (iii) LDA on the basis of a positive first trimester pre-eclampsia screening test. LDA (75mg once daily) shall be given from the first trimester until 36-week gestation. The primary outcome measures include; (i) the proportion of eligible women that agree to participate (acceptability), (ii) compliance with study protocol (acceptability and feasibility), (iii) the proportion of women in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination (feasibility) and (iv) the proportion of women with a completed screening test that are issued the screening result within one week of having the test performed (feasibility). This will be the first clinical trial to determine the efficacy and acceptability in low-risk women of taking routine LDA versus no aspirin versus LDA based on a positive first trimester screening test for the prevention of placental disease. Copyright © 2016 Elsevier Inc. All rights reserved.

N-acetylcysteine in a Double-Blind Randomized Placebo-Controlled Trial: Toward Biomarker-Guided Treatment in Early Psychosis

PubMed Central

Conus, Philippe; Seidman, Larry J; Fournier, Margot; Xin, Lijing; Cleusix, Martine; Baumann, Philipp S; Ferrari, Carina; Cousins, Ann; Alameda, Luis; Gholam-Rezaee, Mehdi; Golay, Philippe; Jenni, Raoul; Woo, T -U Wilson; Keshavan, Matcheri S; Eap, Chin B; Wojcik, Joanne; Cuenod, Michel; Buclin, Thierry; Gruetter, Rolf

2018-01-01

Abstract Biomarker-guided treatments are needed in psychiatry, and previous data suggest oxidative stress may be a target in schizophrenia. A previous add-on trial with the antioxidant N-acetylcysteine (NAC) led to negative symptom reductions in chronic patients. We aim to study NAC’s impact on symptoms and neurocognition in early psychosis (EP) and to explore whether glutathione (GSH)/redox markers could represent valid biomarkers to guide treatment. In a double-blind, randomized, placebo-controlled trial in 63 EP patients, we assessed the effect of NAC supplementation (2700 mg/day, 6 months) on PANSS, neurocognition, and redox markers (brain GSH [GSHmPFC], blood cells GSH levels [GSHBC], GSH peroxidase activity [GPxBC]). No changes in negative or positive symptoms or functional outcome were observed with NAC, but significant improvements were found in favor of NAC on neurocognition (processing speed). NAC also led to increases of GSHmPFC by 23% (P = .005) and GSHBC by 19% (P = .05). In patients with high-baseline GPxBC compared to low-baseline GPxBC, subgroup explorations revealed a link between changes of positive symptoms and changes of redox status with NAC. In conclusion, NAC supplementation in a limited sample of EP patients did not improve negative symptoms, which were at modest baseline levels. However, NAC led to some neurocognitive improvements and an increase in brain GSH levels, indicating good target engagement. Blood GPx activity, a redox peripheral index associated with brain GSH levels, could help identify a subgroup of patients who improve their positive symptoms with NAC. Thus, future trials with antioxidants in EP should consider biomarker-guided treatment. PMID:29462456

Anticipatory Regulation of Action Control in a Simon Task: Behavioral, Electrophysiological, and fMRI Correlates

PubMed Central

Strack, Gamze; Kaufmann, Christian; Kehrer, Stefanie; Brandt, Stephan; Stürmer, Birgit

2013-01-01

With the present study we investigated cue-induced preparation in a Simon task and measured electroencephalogram and functional magnetic resonance imaging (fMRI) data in two within-subjects sessions. Cues informed either about the upcoming (1) spatial stimulus-response compatibility (rule cues), or (2) the stimulus location (position cues), or (3) were non-informative. Only rule cues allowed anticipating the upcoming compatibility condition. Position cues allowed anticipation of the upcoming location of the Simon stimulus but not its compatibility condition. Rule cues elicited fastest and most accurate performance for both compatible and incompatible trials. The contingent negative variation (CNV) in the event-related potential (ERP) of the cue-target interval is an index of anticipatory preparation and was magnified after rule cues. The N2 in the post-target ERP as a measure of online action control was reduced in Simon trials after rule cues. Although compatible trials were faster than incompatible trials in all cue conditions only non-informative cues revealed a compatibility effect in additional indicators of Simon task conflict like accuracy and the N2. We thus conclude that rule cues induced anticipatory re-coding of the Simon task that did not involve cognitive conflict anymore. fMRI revealed that rule cues yielded more activation of the left rostral, dorsal, and ventral prefrontal cortex as well as the pre-SMA as compared to POS and NON-cues. Pre-SMA and ventrolateral prefrontal activation after rule cues correlated with the effective use of rule cues in behavioral performance. Position cues induced a smaller CNV effect and exhibited less prefrontal and pre-SMA contributions in fMRI. Our data point to the importance to disentangle different anticipatory adjustments that might also include the prevention of upcoming conflict via task re-coding. PMID:23408377

Effect of intervention programs in schools to reduce screen time: a meta-analysis.

PubMed

Friedrich, Roberta Roggia; Polet, Jéssica Pinto; Schuch, Ilaine; Wagner, Mário Bernardes

2014-01-01

to evaluate the effects of intervention program strategies on the time spent on activities such as watching television, playing videogames, and using the computer among schoolchildren. a search for randomized controlled trials available in the literature was performed in the following electronic databases: PubMed, Lilacs, Embase, Scopus, Web of Science, and Cochrane Library using the following Keywords randomized controlled trial, intervention studies, sedentary lifestyle, screen time, and school. A summary measure based on the standardized mean difference was used with a 95% confidence interval. a total of 1,552 studies were identified, of which 16 were included in the meta-analysis. The interventions in the randomized controlled trials (n=8,785) showed a significant effect in reducing screen time, with a standardized mean difference (random effect) of: -0.25 (-0.37, -0.13), p<0.01. interventions have demonstrated the positive effects of the decrease of screen time among schoolchildren. Copyright © 2014 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

PubMed Central

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

The curse of planning: dissecting multiple reinforcement-learning systems by taxing the central executive.

PubMed

Otto, A Ross; Gershman, Samuel J; Markman, Arthur B; Daw, Nathaniel D

2013-05-01

A number of accounts of human and animal behavior posit the operation of parallel and competing valuation systems in the control of choice behavior. In these accounts, a flexible but computationally expensive model-based reinforcement-learning system has been contrasted with a less flexible but more efficient model-free reinforcement-learning system. The factors governing which system controls behavior-and under what circumstances-are still unclear. Following the hypothesis that model-based reinforcement learning requires cognitive resources, we demonstrated that having human decision makers perform a demanding secondary task engenders increased reliance on a model-free reinforcement-learning strategy. Further, we showed that, across trials, people negotiate the trade-off between the two systems dynamically as a function of concurrent executive-function demands, and people's choice latencies reflect the computational expenses of the strategy they employ. These results demonstrate that competition between multiple learning systems can be controlled on a trial-by-trial basis by modulating the availability of cognitive resources.

The Curse of Planning: Dissecting multiple reinforcement learning systems by taxing the central executive

PubMed Central

Otto, A. Ross; Gershman, Samuel J.; Markman, Arthur B.; Daw, Nathaniel D.

2013-01-01

A number of accounts of human and animal behavior posit the operation of parallel and competing valuation systems in the control of choice behavior. Along these lines, a flexible but computationally expensive model-based reinforcement learning system has been contrasted with a less flexible but more efficient model-free reinforcement learning system. The factors governing which system controls behavior—and under what circumstances—are still unclear. Based on the hypothesis that model-based reinforcement learning requires cognitive resources, we demonstrate that having human decision-makers perform a demanding secondary task engenders increased reliance on a model-free reinforcement learning strategy. Further, we show that across trials, people negotiate this tradeoff dynamically as a function of concurrent executive function demands and their choice latencies reflect the computational expenses of the strategy employed. These results demonstrate that competition between multiple learning systems can be controlled on a trial-by-trial basis by modulating the availability of cognitive resources. PMID:23558545

Hypnosis for procedure-related pain and distress in pediatric cancer patients: a systematic review of effectiveness and methodology related to hypnosis interventions.

PubMed

Richardson, Janet; Smith, Joanna E; McCall, Gillian; Pilkington, Karen

2006-01-01

The aim of this study was to systematically review and critically appraise the evidence on the effectiveness of hypnosis for procedure-related pain and distress in pediatric cancer patients. A comprehensive search of major biomedical and specialist complementary and alternative medicine databases was conducted. Citations were included from the databases' inception to March 2005. Efforts were made to identify unpublished and ongoing research. Controlled trials were appraised using predefined criteria. Clinical commentaries were obtained for each study. Seven randomized controlled clinical trials and one controlled clinical trial were found. Studies report positive results, including statistically significant reductions in pain and anxiety/distress, but a number of methodological limitations were identified. Systematic searching and appraisal has demonstrated that hypnosis has potential as a clinically valuable intervention for procedure-related pain and distress in pediatric cancer patients. Further research into the effectiveness and acceptability of hypnosis for pediatric cancer patients is recommended.

Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial.

PubMed

Muto, Carmine; Calvi, Valeria; Botto, Giovanni Luca; Pecora, Domenico; Ciaramitaro, Gianfranco; Valsecchi, Sergio; Malacrida, Maurizio; Maglia, Giampiero

2014-11-01

The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID:NCT01647490). Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov: NCT01647490. Copyright © 2014 Elsevier Inc. All rights reserved.

Tracheal intubation in critically ill patients: a comprehensive systematic review of randomized trials.

PubMed

Cabrini, Luca; Landoni, Giovanni; Baiardo Radaelli, Martina; Saleh, Omar; Votta, Carmine D; Fominskiy, Evgeny; Putzu, Alessandro; Snak de Souza, Cézar Daniel; Antonelli, Massimo; Bellomo, Rinaldo; Pelosi, Paolo; Zangrillo, Alberto

2018-01-20

We performed a systematic review of randomized controlled studies evaluating any drug, technique or device aimed at improving the success rate or safety of tracheal intubation in the critically ill. We searched PubMed, BioMed Central, Embase and the Cochrane Central Register of Clinical Trials and references of retrieved articles. Finally, pertinent reviews were also scanned to detect further studies until May 2017. The following inclusion criteria were considered: tracheal intubation in adult critically ill patients; randomized controlled trial; study performed in Intensive Care Unit, Emergency Department or ordinary ward; and work published in the last 20 years. Exclusion criteria were pre-hospital or operating theatre settings and simulation-based studies. Two investigators selected studies for the final analysis. Extracted data included first author, publication year, characteristics of patients and clinical settings, intervention details, comparators and relevant outcomes. The risk of bias was assessed with the Cochrane Collaboration's Risk of Bias tool. We identified 22 trials on use of a pre-procedure check-list (1 study), pre-oxygenation or apneic oxygenation (6 studies), sedatives (3 studies), neuromuscular blocking agents (1 study), patient positioning (1 study), video laryngoscopy (9 studies), and post-intubation lung recruitment (1 study). Pre-oxygenation with non-invasive ventilation (NIV) and/or high-flow nasal cannula (HFNC) showed a possible beneficial role. Post-intubation recruitment improved oxygenation , while ramped position increased the number of intubation attempts and thiopental had negative hemodynamic effects. No effect was found for use of a checklist, apneic oxygenation (on oxygenation and hemodynamics), videolaryngoscopy (on number and length of intubation attempts), sedatives and neuromuscular blockers (on hemodynamics). Finally, videolaryngoscopy was associated with severe adverse effects in multiple trials. The limited available evidence supports a beneficial role of pre-oxygenation with NIV and HFNC before intubation of critically ill patients. Recruitment maneuvers may increase post-intubation oxygenation. Ramped position increased the number of intubation attempts; thiopental had negative hemodynamic effects and videolaryngoscopy might favor adverse events.

Effects of systematic prone positioning in hypoxemic acute respiratory failure: a randomized controlled trial.

PubMed

Guerin, Claude; Gaillard, Sandrine; Lemasson, Stephane; Ayzac, Louis; Girard, Raphaele; Beuret, Pascal; Palmier, Bruno; Le, Quoc Viet; Sirodot, Michel; Rosselli, Sylvaine; Cadiergue, Vincent; Sainty, Jean-Marie; Barbe, Philippe; Combourieu, Emmanuel; Debatty, Daniel; Rouffineau, Jean; Ezingeard, Eric; Millet, Olivier; Guelon, Dominique; Rodriguez, Luc; Martin, Olivier; Renault, Anne; Sibille, Jean-Paul; Kaidomar, Michel

2004-11-17

A recent trial showed that placing patients with acute lung injury in the prone position did not increase survival; however, whether those results hold true for patients with hypoxemic acute respiratory failure (ARF) is unclear. To determine whether prone positioning improves mortality in ARF patients. Prospective, unblinded, multicenter controlled trial of 791 ARF patients in 21 general intensive care units in France using concealed randomization conducted from December 14, 1998, through December 31, 2002. To be included, patients had to be at least 18 years, hemodynamically stable, receiving mechanical ventilation, and intubated and had to have a partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FIO2) ratio of 300 or less and no contraindications to lying prone. Patients were randomly assigned to prone position placement (n = 413), applied as early as possible for at least 8 hours per day on standard beds, or to supine position placement (n = 378). The primary end point was 28-day mortality; secondary end points were 90-day mortality, duration of mechanical ventilation, incidence of ventilator-associated pneumonia (VAP), and oxygenation. The 2 groups were comparable at randomization. The 28-day mortality rate was 32.4% for the prone group and 31.5% for the supine group (relative risk [RR], 0.97; 95% confidence interval [CI], 0.79-1.19; P = .77). Ninety-day mortality for the prone group was 43.3% vs 42.2% for the supine group (RR, 0.98; 95% CI, 0.84-1.13; P = .74). The mean (SD) duration of mechanical ventilation was 13.7 (7.8) days for the prone group vs 14.1 (8.6) days for the supine group (P = .93) and the VAP incidence was 1.66 vs 2.14 episodes per 100-patients days of intubation, respectively (P = .045). The PaO2/FIO2 ratio was significantly higher in the prone group during the 28-day follow-up. However, pressure sores, selective intubation, and endotracheal tube obstruction incidences were higher in the prone group. This trial demonstrated no beneficial outcomes and some safety concerns associated with prone positioning. For patients with hypoxemic ARF, prone position placement may lower the incidence of VAP.

The effect of a corrective functional exercise program on postural thoracic kyphosis in teenagers: a randomized controlled trial.

PubMed

Feng, Qiang; Wang, Mei; Zhang, Yanfeng; Zhou, Yu

2018-01-01

To investigate the effects of a corrective functional exercise program on postural thoracic kyphosis in teenagers in China. A single-blind randomized controlled trial including students with a thoracic kyphosis angle (TKA) >40° measured using the SpinalMouse. China Institute of Sport Science and three middle schools in Beijing, China. A total of 181 subjects were included in this trial; of these, 164 subjects were included in the analyses (intervention group, n = 81; control group, n = 83). The intervention group received a functional exercise program designed to correct postural thoracic kyphosis, and the control group received an exercise program designed in accordance with the state-regulated curriculum. The primary outcome variable was TKA. Secondary outcome variables were lumbar lordosis angle (LLA), sacral angle (SA), and incline angle (INA) measured in the upright position; thoracic, lumbar, and sacral spine range of motion (ROM) and INA ROM (change in center of gravity) measured in the forward bending and extended positions; and changes in TKA, LLA, SA, and INA measured during the Matthiass test. There were significant differences in pretest and posttest TKA in both groups (intervention group: pretest 47.09 ± 5.45, posttest 38.31 ± 9.18, P < 0.0001; control group: pretest 47.47 ± 6.06, posttest 43.59 ± 7.49, P < 0.0001). After adjustment for gender and pretest values, there were significant differences in posttest TKA, change in SA, and thoracic ROM in the intervention group compared to the control group ( P < 0.05). The corrective functional exercise program designed for this study improved exaggerated thoracic kyphosis in teenagers.

Atomoxetine Treatment Strengthens an Anti-Correlated Relationship between Functional Brain Networks in Medication-Naïve Adults with Attention-Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Clinical Trial

PubMed Central

Lin, Hsiang-Yuan

2016-01-01

Background: Although atomoxetine demonstrates efficacy in individuals with attention-deficit hyperactivity disorder, its treatment effects on brain resting-state functional connectivity remain unknown. Therefore, we aimed to investigate major brain functional networks in medication-naïve adults with attention-deficit hyperactivity disorder and the efficacy of atomoxetine treatment on resting-state functional connectivity. Methods: After collecting baseline resting-state functional MRI scans from 24 adults with attention-deficit hyperactivity disorder (aged 18–52 years) and 24 healthy controls (matched in demographic characteristics), the participants with attention-deficit hyperactivity disorder were randomly assigned to atomoxetine (n=12) and placebo (n=12) arms in an 8-week, double-blind, placebo-controlled trial. The primary outcome was functional connectivity assessed by a resting-state functional MRI. Seed-based functional connectivity was calculated and compared for the affective, attention, default, and cognitive control networks. Results: At baseline, we found atypical cross talk between the default, cognitive control, and dorsal attention networks and hypoconnectivity within the dorsal attention and default networks in adults with attention-deficit hyperactivity disorder. Our first-ever placebo-controlled clinical trial incorporating resting-state functional MRI showed that treatment with atomoxetine strengthened an anticorrelated relationship between the default and task-positive networks and modulated all major brain networks. The strengthened anticorrelations were associated with improving clinical symptoms in the atomoxetine-treated adults. Conclusions: Our results support the idea that atypical default mode network task-positive network interaction plays an important role in the pathophysiology of adult attention-deficit hyperactivity disorder. Strengthening this atypical relationship following atomoxetine treatment suggests an important pathway to treat attention-deficit hyperactivity disorder. PMID:26377368

Skin disinfection with octenidine dihydrochloride for central venous catheter site care: a double-blind, randomized, controlled trial.

PubMed

Dettenkofer, M; Wilson, C; Gratwohl, A; Schmoor, C; Bertz, H; Frei, R; Heim, D; Luft, D; Schulz, S; Widmer, A F

2010-06-01

To compare the efficacy of two commercially available, alcohol-based antiseptic solutions for preparation and care of central venous catheter (CVC) insertion sites, with and without octenidine dihydrochloride, a double-blind, randomized, controlled trial was undertaken in the haematology units and in one surgical unit of two university hospitals. Adult patients with a non-tunnelled CVC were randomly assigned to two different skin disinfection regimens at the insertion site: 0.1% octenidine with 30% 1-propanol and 45% 2-propanol, and as control 74% ethanol with 10% 2-propanol. Endpoints were (i) skin colonization at the insertion site; (ii) positive culture from the catheter tip (> or = 15 CFU); and (iii) occurrence of CVC-associated bloodstream infection (defined according to criteria set by the CDC). Four hundred patients with inserted CVC were enrolled from May 2002 through April 2005. Both groups were similar in respect of patient characteristics and co-morbidities. Skin colonization at the CVC insertion site during the first 10 days was significantly reduced by octenidine treatment (relative difference octenidine vs. control: 0.21; 95%CI: 0.11-0.39, p <0.0001). Positive culture of the catheter tip was significantly less frequent in the octenidine group (7.9%) than in the control group (17.8%): OR = 0.39 (95%CI: 0.20-0.80, p 0.009). Patients treated with octenidine had a non-significant reduction in catheter-associated bloodstream infections (4.1% vs. 8.3%; OR = 0.44; 95%CI: 0.18-1.08, p 0.081). Side effects were similar in both groups. This randomized controlled trial supports the results of two observational studies demonstrating octenidine in alcoholic solution to be a better option than alcohol alone for the prevention of CVC-associated infections.

Atomoxetine Treatment Strengthens an Anti-Correlated Relationship between Functional Brain Networks in Medication-Naïve Adults with Attention-Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

PubMed

Lin, Hsiang-Yuan; Gau, Susan Shur-Fen

2015-09-16

Although atomoxetine demonstrates efficacy in individuals with attention-deficit hyperactivity disorder, its treatment effects on brain resting-state functional connectivity remain unknown. Therefore, we aimed to investigate major brain functional networks in medication-naïve adults with attention-deficit hyperactivity disorder and the efficacy of atomoxetine treatment on resting-state functional connectivity. After collecting baseline resting-state functional MRI scans from 24 adults with attention-deficit hyperactivity disorder (aged 18-52 years) and 24 healthy controls (matched in demographic characteristics), the participants with attention-deficit hyperactivity disorder were randomly assigned to atomoxetine (n=12) and placebo (n=12) arms in an 8-week, double-blind, placebo-controlled trial. The primary outcome was functional connectivity assessed by a resting-state functional MRI. Seed-based functional connectivity was calculated and compared for the affective, attention, default, and cognitive control networks. At baseline, we found atypical cross talk between the default, cognitive control, and dorsal attention networks and hypoconnectivity within the dorsal attention and default networks in adults with attention-deficit hyperactivity disorder. Our first-ever placebo-controlled clinical trial incorporating resting-state functional MRI showed that treatment with atomoxetine strengthened an anticorrelated relationship between the default and task-positive networks and modulated all major brain networks. The strengthened anticorrelations were associated with improving clinical symptoms in the atomoxetine-treated adults. Our results support the idea that atypical default mode network task-positive network interaction plays an important role in the pathophysiology of adult attention-deficit hyperactivity disorder. Strengthening this atypical relationship following atomoxetine treatment suggests an important pathway to treat attention-deficit hyperactivity disorder. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Alleviating Parenting Stress in Parents with Intellectual Disabilities: A Randomized Controlled Trial of a Video-Feedback Intervention to Promote Positive Parenting

ERIC Educational Resources Information Center

Hodes, Marja W.; Meppelder, Marieke; Moor, Marleen; Kef, Sabina; Schuengel, Carlo

2017-01-01

Background: Adapted parenting support may alleviate the high levels of parenting stress experienced by many parents with intellectual disabilities. Methods: Parents with mild intellectual disabilities or borderline intellectual functioning were randomized to experimental (n = 43) and control (n = 42) conditions. Parents in both groups received…

The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD.

PubMed

Schmickl, Christopher N; Li, Man; Li, Guangxi; Wetzstein, Marnie M; Herasevich, Vitaly; Gajic, Ognjen; Benzo, Roberto P

2011-10-01

Participant recruitment is an important process in successful conduct of randomized controlled trials. To facilitate enrollment into a National Institutes of Health-sponsored clinical trial involving patients with chronic obstructive pulmonary disease (COPD), we developed and prospectively validated an automated electronic screening tool based on boolean free-text search of admission notes in electronic medical records. During a 2-week validation period, all patients admitted to prespecified general medical services were screened for eligibility by both the electronic screening tool and a COPD nurse. Group discussion was the gold standard for confirmation of true-positive results. Compared with the gold standard, electronic screening yielded 100% sensitivity, 92% specificity, 100% negative predictive value, and 72% positive predictive value. Compared with traditional manual screening, electronic screening demonstrated time-saving potential of 76%. Thus, the electronic screening tool accurately identifies potential study subjects and improves efficiency of patient accrual for a clinical trial on COPD. This method may be expanded into other institutional and clinical settings. Copyright © 2011 Elsevier Ltd. All rights reserved.

How might acupuncture work? A systematic review of physiologic rationales from clinical trials.

PubMed

Moffet, Howard H

2006-07-07

Scientific interest in acupuncture has led numerous investigators to conduct clinical trials to test the efficacy of acupuncture for various conditions, but the mechanisms underlying acupuncture are poorly understood. The author conducted a PubMed search to obtain a fair sample of acupuncture clinical trials published in English in 2005. Each article was reviewed for a physiologic rationale, as well as study objectives and outcomes, experimental and control interventions, country of origin, funding sources and journal type. Seventy-nine acupuncture clinical trials were identified. Twenty-six studies (33%) offered no physiologic rationale. Fifty-three studies (67%) posited a physiologic basis for acupuncture: 33 (62% of 53) proposed neurochemical mechanisms, 2 (4%) segmental nervous system effects, 6 (11%) autonomic nervous system regulation, 3 (6%) local effects, 5 (9%) effects on brain function and 5 (9%) other effects. No rationale was proposed for stroke; otherwise having a rationale was not associated with objective, positive or negative findings, means of intervention, country of origin, funding source or journal type. The dominant explanation for how acupuncture might work involves neurochemical responses and is not reported to be dependent on treatment objective, specific points, means or method of stimulation. Many acupuncture trials fail to offer a meaningful rationale, but proposing a rationale can help investigators to develop and test a causal hypothesis, choose an appropriate control and rule out placebo effects. Acupuncture may stimulate self-regulatory processes independent of the treatment objective, points, means or methods used; this would account for acupuncture's reported benefits in so many disparate pathologic conditions.

Mobile-phone dispatch of laypersons for CPR in out-of-hospital cardiac arrest.

PubMed

Ringh, Mattias; Rosenqvist, Mårten; Hollenberg, Jacob; Jonsson, Martin; Fredman, David; Nordberg, Per; Järnbert-Pettersson, Hans; Hasselqvist-Ax, Ingela; Riva, Gabriel; Svensson, Leif

2015-06-11

Cardiopulmonary resuscitation (CPR) performed by bystanders is associated with increased survival rates among persons with out-of-hospital cardiac arrest. We investigated whether rates of bystander-initiated CPR could be increased with the use of a mobile-phone positioning system that could instantly locate mobile-phone users and dispatch lay volunteers who were trained in CPR to a patient nearby with out-of-hospital cardiac arrest. We conducted a blinded, randomized, controlled trial in Stockholm from April 2012 through December 2013. A mobile-phone positioning system that was activated when ambulance, fire, and police services were dispatched was used to locate trained volunteers who were within 500 m of patients with out-of-hospital cardiac arrest; volunteers were then dispatched to the patients (the intervention group) or not dispatched to them (the control group). The primary outcome was bystander-initiated CPR before the arrival of ambulance, fire, and police services. A total of 5989 lay volunteers who were trained in CPR were recruited initially, and overall 9828 were recruited during the study. The mobile-phone positioning system was activated in 667 out-of-hospital cardiac arrests: 46% (306 patients) in the intervention group and 54% (361 patients) in the control group. The rate of bystander-initiated CPR was 62% (188 of 305 patients) in the intervention group and 48% (172 of 360 patients) in the control group (absolute difference for intervention vs. control, 14 percentage points; 95% confidence interval, 6 to 21; P<0.001). A mobile-phone positioning system to dispatch lay volunteers who were trained in CPR was associated with significantly increased rates of bystander-initiated CPR among persons with out-of-hospital cardiac arrest. (Funded by the Swedish Heart-Lung Foundation and Stockholm County; ClinicalTrials.gov number, NCT01789554.).

The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study.

PubMed

Schwizer, Werner; Menne, Dieter; Schütze, Kurt; Vieth, Michael; Goergens, Reiner; Malfertheiner, Peter; Leodolter, Andreas; Fried, Michael; Fox, Mark R

2013-08-01

This study aimed to resolve controversy regarding the effects of Helicobacter pylori eradication therapy and H. pylori infection in gastro-oesophageal reflux disease. A randomized, double-blind, multicentre trial was performed in patients presenting with reflux symptoms. H. pylori-positive patients were randomized to receive either antibiotics or placebo for 7 days. H. pylori-negative patient controls received placebo. All received esomeprazole 20 mg b.d. for 7 days, followed by 40 mg o.d. to complete an 8-week course, and were followed up for 32 weeks by telephone. In this study, 198/589 (34%) patients were H. pylori-positive and 113 H. pylori-negative patients served as controls. Baseline endoscopy revealed 63% Los Angeles grade 0A and 37% Los Angeles grade BCD oesophagitis with no difference between patient groups. Symptom improvement on esomeprazole was seen in 89%. H. pylori eradication was successful in 82%. H. pylori eradication had no effect on symptomatic relapse (hazard ratio 1.15, 95% CI 0.74-1.8; p = 0.5). Overall, H. pylori-positive patients had a lower probability of relapse compared to H. pylori-negative controls (hazard ratio 0.6, 95% CI 0.43-0.85; p = 0.004). Relapse hazard was modulated also by oesophagitis grade (BCD vs. 0A, hazard ratio 2.1, 95% CI 1.5-3.0). Relapse of gastro-oesophageal reflux disease symptoms after a course of high dose acid suppression took longer for H. pylori-positive patients than H. pylori-negative controls; however eradication therapy had no effect on the risk of relapse; ClincialTrials.gov number, NCT00574925.

The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study

PubMed Central

Menne, Dieter; Schütze, Kurt; Vieth, Michael; Goergens, Reiner; Malfertheiner, Peter; Leodolter, Andreas; Fried, Michael; Fox, Mark R

2013-01-01

Objectives This study aimed to resolve controversy regarding the effects of Helicobacter pylori eradication therapy and H. pylori infection in gastro-oesophageal reflux disease. Design A randomized, double-blind, multicentre trial was performed in patients presenting with reflux symptoms. H. pylori-positive patients were randomized to receive either antibiotics or placebo for 7 days. H. pylori-negative patient controls received placebo. All received esomeprazole 20 mg b.d. for 7 days, followed by 40 mg o.d. to complete an 8-week course, and were followed up for 32 weeks by telephone. Results In this study, 198/589 (34%) patients were H. pylori-positive and 113 H. pylori-negative patients served as controls. Baseline endoscopy revealed 63% Los Angeles grade 0A and 37% Los Angeles grade BCD oesophagitis with no difference between patient groups. Symptom improvement on esomeprazole was seen in 89%. H. pylori eradication was successful in 82%. H. pylori eradication had no effect on symptomatic relapse (hazard ratio 1.15, 95% CI 0.74–1.8; p = 0.5). Overall, H. pylori-positive patients had a lower probability of relapse compared to H. pylori-negative controls (hazard ratio 0.6, 95% CI 0.43–0.85; p = 0.004). Relapse hazard was modulated also by oesophagitis grade (BCD vs. 0A, hazard ratio 2.1, 95% CI 1.5–3.0). Conclusion Relapse of gastro-oesophageal reflux disease symptoms after a course of high dose acid suppression took longer for H. pylori-positive patients than H. pylori-negative controls; however eradication therapy had no effect on the risk of relapse; ClincialTrials.gov number, NCT00574925. PMID:24917966

Tilt Table Therapies for Patients with Severe Disorders of Consciousness: A Randomized, Controlled Trial

PubMed Central

Krewer, Carmen; Luther, Marianne; Koenig, Eberhard; Müller, Friedemann

2015-01-01

One major aim of the neurological rehabilitation of patients with severe disorders of consciousness (DOC) is to enhance patients’ arousal and ability to communicate. Mobilization into a standing position by means of a tilt table has been shown to improve their arousal and awareness. However, due to the frequent occurrence of syncopes on a tilt table, it is easier to accomplish verticalization using a tilt table with an integrated stepping device. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of a tilt table therapy with or without an integrated stepping device on the level of consciousness. A total of 50 participants in vegetative or minimally conscious states 4 weeks to 6 month after injury were treated with verticalization during this randomized controlled trial. Interventions involved ten 1-hour sessions of the specific treatment over a 3-week period. Blinded assessors made measurements before and after the intervention period, as well as after a 3-week follow-up period. The coma recovery scale-revised (CRS-R) showed an improvement by a median of 2 points for the group receiving tilt table with integrated stepping (Erigo). The rate of recovery of the group receiving the conventional tilt table therapy significantly increased by 5 points during treatment and by an additional 2 points during the 3-week follow-up period. Changes in spasticity did not significantly differ between the two intervention groups. Compared to the conventional tilt table, the tilt table with integrated stepping device failed to have any additional benefit for DOC patients. Verticalization itself seems to be beneficial though and should be administered to patients in DOC in early rehabilitation. Trial Registration: Current Controlled Trials Ltd (www.controlled-trials.com), identifier number ISRCTN72853718 PMID:26623651

Tilt Table Therapies for Patients with Severe Disorders of Consciousness: A Randomized, Controlled Trial.

PubMed

Krewer, Carmen; Luther, Marianne; Koenig, Eberhard; Müller, Friedemann

2015-01-01

One major aim of the neurological rehabilitation of patients with severe disorders of consciousness (DOC) is to enhance patients' arousal and ability to communicate. Mobilization into a standing position by means of a tilt table has been shown to improve their arousal and awareness. However, due to the frequent occurrence of syncopes on a tilt table, it is easier to accomplish verticalization using a tilt table with an integrated stepping device. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of a tilt table therapy with or without an integrated stepping device on the level of consciousness. A total of 50 participants in vegetative or minimally conscious states 4 weeks to 6 month after injury were treated with verticalization during this randomized controlled trial. Interventions involved ten 1-hour sessions of the specific treatment over a 3-week period. Blinded assessors made measurements before and after the intervention period, as well as after a 3-week follow-up period. The coma recovery scale-revised (CRS-R) showed an improvement by a median of 2 points for the group receiving tilt table with integrated stepping (Erigo). The rate of recovery of the group receiving the conventional tilt table therapy significantly increased by 5 points during treatment and by an additional 2 points during the 3-week follow-up period. Changes in spasticity did not significantly differ between the two intervention groups. Compared to the conventional tilt table, the tilt table with integrated stepping device failed to have any additional benefit for DOC patients. Verticalization itself seems to be beneficial though and should be administered to patients in DOC in early rehabilitation. Trial Registration: Current Controlled Trials Ltd (www.controlled-trials.com), identifier number ISRCTN72853718.

Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey.

PubMed

Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Z; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

2017-07-01

Conflicts of interest (COIs) are increasingly recognized as important to disclose and manage in health research. The objective of this study was to assess the reporting of both financial and nonfinancial COI by authors of randomized controlled trials published in a representative sample of clinical journals. We searched Ovid Medline and included a random sample of 200 randomized controlled trials published in 2015 in one of the 119 Core Clinical Journals. We classified COI using a comprehensive framework that includes the following: individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses. Of the 200 randomized controlled trials, 188 (94%) reported authors' COI disclosures that were available in the main document (92%) and as International Committee of Medical Journal Editors forms accessible online (12%). Of the 188 trials, 57% had at least one author reporting at least one COI; in all these trials, at least one author reported financial COI. Institutional COIs (11%) and nonfinancial COIs (4%) were less commonly reported. References to COI disclosure statements for editors (1%) and medical writers (0%) were seldom present. Regression analyses showed positive associations between reporting individual financial COI and higher journal impact factor (odds ratio [OR] = 1.06, 95% confidence interval [CI] = 1.02-1.10), larger number of authors (OR = 1.10, 95% CI 1.02-1.20), affiliation with an institution from a high-income country (OR = 16.75, 95% CI 3.38-82.87), and trials reporting on pharmacological interventions (OR = 2.28, 95% CI 1.13-4.62). More than half of published randomized controlled trials report that at least one author has a COI. Trial authors report financial COIs more often than nonfinancial COIs and individual COIs more frequently than institutional COIs. Copyright © 2017 Elsevier Inc. All rights reserved.

How do parents experience being asked to enter a child in a randomised controlled trial?

PubMed

Shilling, Valerie; Young, Bridget

2009-02-16

As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enroll their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfillment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties.

Traditional Indigenous Games promoting physical activity and cultural connectedness in primary schools--cluster randomised control trial.

PubMed

Kiran, Asha; Knights, Janice

2010-08-01

This study investigated the effectiveness of Traditional Indigenous Games (TIG) to improve physical activity and cultural connectedness among primary school students in the community renewal areas of Townsville in North Queensland. A cluster randomised control trial was conducted in four primary schools in 2007. Baseline and post implementation surveys were conducted in two intervention and two control schools and the results were compared. TIG delivered in primary schools every week over period of three months did not contribute to any statistically significant improvement in intervention and control groups in physical activity levels or cultural connectedness. Further research specifically in terms of intensity and duration of TIG may inform whether physical activity may be improved. Enhancing the Indigenous cultural features of the existing TIG kit might positively influence Indigenous cultural connectedness.

Effectiveness of Global Postural Re-education for Treatment of Spinal Disorders: A Meta-analysis.

PubMed

Lomas-Vega, Rafael; Garrido-Jaut, María Victoria; Rus, Alma; Del-Pino-Casado, Rafael

2017-02-01

The aim of this study was to investigate the effects of global postural re-education (GPR) on the treatment of spinal disorders by performing a systematic review and a meta-analysis. MEDLINE, Scopus, and PEDro databases were searched without language or publication date restrictions. Data on pain and function were used to evaluate the effectiveness of GPR. Randomized controlled trials and controlled clinical trials analyzing the effectiveness of GPR on spinal disorders were selected. The standardized mean difference (SMD) and the corresponding 95% confidence interval (95% CI) were calculated. The meta-analysis was performed using the Comprehensive Meta-analysis 3.3 software. Seven randomized controlled trials and 4 controlled clinical trials were included in the meta-analysis. The results showed a medium improvement on pain (SMD = -0.63; 95% CI, -0.43 to -0.83) and function (SMD = -0.48; 95% CI, -0.25 to -0.72) after GPR treatment. The positive effect, which was greater in patients with ankylosing spondylitis followed by low back pain and neck pain, was more significant during the intermediate follow-up than immediately after treatment. This meta-analysis provides reliable evidence that GPR may be an effective method for treating spinal disorders by decreasing pain and improving function.

Tai Chi exercise in improving cardiorespiratory capacity.

PubMed

Thornton, Everard W

2008-01-01

To evaluate evidence relating to effects of Tai Chi on cardiovascular outcomes, with emphasis on randomised control designs. Studies reviewed in 2004 were re-examined, together with more recent controlled trials of Tai Chi relating to cardiovascular outcome. The analysis provided comment on problems associated with randomised control design, including sources of bias in such trials. With a single exception, data support reduction of baseline systolic/diastolic blood pressure (BP). While there may be positive bias in these studies, data are from diverse ethnic groups, different gender, age, and level of functional ability. There are no data relating to BP reactive change to subsequent stressors. Few studies consider potential mediating mechanisms through which Tai Chi may provide these benefits. Caution is advocated in using randomised controlled trials as the only effective type of study. Such designs are difficult to conduct and effective trials are more likely given a better understanding of the mediating mechanism(s) through which benefits may be derived. It is currently unclear how changes in BP are derived. Some data indicate a shift to increased vagal relative to sympathetic dominance and there may be other potential physiological mediators. No study has examined relationships between potential psychological gains such as self-efficacy and BP change, or individual differences in outcomes.

Biofeedback for pain management during labour.

PubMed

Barragán Loayza, Irma Marcela; Solà, Ivan; Juandó Prats, Clara

2011-06-15

Labour is often associated with pain and discomfort caused by a complex and subjective interaction of multiple factors, and should be understood within a multi-dimensional and multi-disciplinary framework. Within the non-pharmacological approach, biofeedback has focused on the acquisition of control over some physiological responses with the aid of electronic devices, allowing individuals to regulate some physical processes (such as pain) which are not usually under conscious control. The role of this behavioural approach for the management of pain during labour, as an addition to the standard prenatal care, has been never assessed systematically. This review is one in a series of Cochrane reviews examining pain relief in labour, which will contribute to an overview of systematic reviews of pain relief for women in labour (in preparation). To examine the effectiveness of the use of biofeedback in prenatal lessons for managing pain during labour. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2011), CENTRAL (The Cochrane Library 2011, Issue 1), PubMed (1950 to 20 March 2011), EMBASE (via OVID) (1980 to 24 March 2011), CINAHL (EBSCOhost) (1982 to 24 March 2011), and PsycINFO (via Ovid) (1806 to 24 March 2011). We searched for further studies in the reference lists of identified articles. Randomised controlled trials of any form of prenatal classes which included biofeedback, in any modality, in women with low-risk pregnancies. Two authors independently assessed trial quality and extracted data. The review included four trials (186 women) that hugely differed in terms of the diversity of the intervention modalities and outcomes measured. Most trials assessed the effects of electromyographic biofeedback in women who were pregnant for the first time. The trials were judged to be at a high risk of bias due to the lack of data describing the sources of bias assessed. There was no significant evidence of a difference between biofeedback and control groups in terms of assisted vaginal birth, caesarean section, augmentation of labour and the use of pharmacological pain relief. The results of the included trials showed that the use of biofeedback to reduce the pain in women during labour is unproven. Electromyographic biofeedback may have some positive effects early in labour, but as labour progresses there is a need for additional pharmacological analgesia. Despite some positive results shown in the included trials, there is insufficient evidence that biofeedback is effective for the management of pain during labour.

Experimental masseter muscle pain alters jaw-neck motor strategy.

PubMed

Wiesinger, B; Häggman-Henrikson, B; Hellström, F; Wänman, A

2013-08-01

A functional integration between the jaw and neck regions has been demonstrated during normal jaw function. The effect of masseter muscle pain on this integrated motor behaviour in man is unknown. The aim of this study was to investigate the effect of induced masseter muscle pain on jaw-neck movements during a continuous jaw opening-closing task. Sixteen healthy men performed continuous jaw opening-closing movements to a target position, defined as 75% of the maximum jaw opening. Each subject performed two trials without pain (controls) and two trials with masseter muscle pain, induced with hypertonic saline as a single injection. Simultaneous movements of the mandible and the head were registered with a wireless optoelectronic three-dimensional recording system. Differences in movement amplitudes between trials were analysed with Friedman's test and corrected Wilcoxon matched pairs test. The head movement amplitudes were significantly larger during masseter muscle pain trials compared with control. Jaw movement amplitudes did not differ significantly between any of the trials after corrected Wilcoxon tests. The ratio between head and jaw movement amplitudes was significantly larger during the first pain trial compared with control. Experimental masseter muscle pain in humans affected integrated jaw-neck movements by increasing the neck component during continuous jaw opening-closing tasks. The findings indicate that pain can alter the strategy for jaw-neck motor control, which further underlines the functional integration between the jaw and neck regions. This altered strategy may have consequences for development of musculoskeletal pain in the jaw and neck regions. © 2012 European Federation of International Association for the Study of Pain Chapters.

Effect of exercise on cognitive function in chronic disease patients: a meta-analysis and systematic review of randomized controlled trials

PubMed Central

Cai, Hong; Li, Guichen; Hua, Shanshan; Liu, Yufei; Chen, Li

2017-01-01

Background The purpose of this study was to conduct a meta-analysis and systematic review to assess the effect of exercise on cognitive function in people with chronic diseases. Methods PubMed, Web of Science, Embase, the Cochrane Library, CINAHL, PsycINFO, and three Chinese databases were electronically searched for papers that were published until September 2016. This meta-analysis and systematic review included randomized controlled trials that evaluated the effect of exercise on cognitive function compared with control group for people with chronic diseases. Results Totally, 35 studies met the inclusion criteria, with 3,113 participants. The main analysis revealed a positive overall random effect of exercise intervention on cognitive function in patients with chronic diseases. The secondary analysis revealed that aerobic exercise interventions and aerobic included exercise interventions had a positive effect on cognition in patients with chronic diseases. The intervention offering low frequency had a positive effect on cognitive function in patients with chronic diseases. Finally, we found that interventions offered at both low exercise intensity and moderate exercise intensity had a positive effect on cognitive function in patients with chronic diseases. The secondary analysis also revealed that exercise interventions were beneficial in Alzheimer’s disease patients when grouped by disease type. Conclusion This meta-analysis and systematic review suggests that exercise interventions positively influence cognitive function in patients with chronic diseases. Beneficial effect was independent of the type of disease, type of exercise, frequency, and the intensity of the exercise intervention. PMID:28546744

Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study.

PubMed

Hilton, Paul; Buckley, Brian S; McColl, Elaine; Howel, Denise; Tincello, Douglas G; Brennand, Catherine

2016-10-26

The INVESTIGATE-I study was designed to inform a future definitive randomised trial of invasive urodynamic testing, compared to basic clinical assessment with noninvasive tests prior to surgical treatment, in women with stress urinary incontinence or stress-predominant mixed urinary incontinence. In a pilot randomised controlled trial, women from seven participating sites were screened, consented and randomised. Overall, 771 patients were identified from clinic notes and correspondence as being potential recruits and were sent the Patient Information Leaflet. Of those screened, 284 were deemed eligible, giving an overall 'screen positive' rate of 37 %. The numbers screened at individual centres varied between 14 and 399; the 'screen positive' rate varied between 22 and 79 % and the percentage of eligible women recruited varied between 55 and 100 %. The aim of this additional substudy was to explore why 'screen positive' rates may have varied so widely between apparently similar sites. All 11 trial staff involved in screening in the seven recruiting sites were asked to evaluate a series of 20 identical vignettes, mainly based on actual general practitioner referral letters. Of the vignettes, 16 mentioned one or more definite inclusion criteria; the remainder had possible inclusions. Four had definite exclusions; 12 had possible exclusions. Free-text comments were sought to clarify the screeners' decisions. For six vignettes everyone agreed that the patient was eligible; for one all agreed she was not eligible; the breakdown for the remainder was mixed. Free-text comments illuminated uncertainties that may have led to variability in judging potential eligibility. Variability in judgements about potential trial eligibility highlights the importance of explicit and objective inclusion and exclusion criteria, and of agreed strategies for making judgements when information is missing. During the development and planning of trials, vignettes might be a valuable tool for training those involved in screening and recruiting patients, for identifying potential problems and ensuring greater consistency in the application of eligibility criteria. ISTCTN registry: ISRCTN71327395 , registered on 7 June 2010.

Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial.

PubMed

Chabala, Chishala; Turkova, Anna; Thomason, Margaret J; Wobudeya, Eric; Hissar, Syed; Mave, Vidya; van der Zalm, Marieke; Palmer, Megan; Kapasa, Monica; Bhavani, Perumal K; Balaji, Sarath; Raichur, Priyanka A; Demers, Anne-Marie; Hoddinott, Graeme; Owen-Powell, Ellen; Kinikar, Aarti; Musoke, Philippa; Mulenga, Veronica; Aarnoutse, Rob; McIlleron, Helen; Hesseling, Anneke; Crook, Angela M; Cotton, Mark; Gibb, Diana M

2018-04-19

Tuberculosis (TB) in children is frequently paucibacillary and non-severe forms of pulmonary TB are common. Evidence for tuberculosis treatment in children is largely extrapolated from adult studies. Trials in adults with smear-negative tuberculosis suggest that treatment can be effectively shortened from 6 to 4 months. New paediatric, fixed-dose combination anti-tuberculosis treatments have recently been introduced in many countries, making the implementation of World Health Organisation (WHO)-revised dosing recommendations feasible. The safety and efficacy of these higher drug doses has not been systematically assessed in large studies in children, and the pharmacokinetics across children representing the range of weights and ages should be confirmed. SHINE is a multicentre, open-label, parallel-group, non-inferiority, randomised controlled, two-arm trial comparing a 4-month vs the standard 6-month regimen using revised WHO paediatric anti-tuberculosis drug doses. We aim to recruit 1200 African and Indian children aged below 16 years with non-severe TB, with or without HIV infection. The primary efficacy and safety endpoints are TB disease-free survival 72 weeks post randomisation and grade 3 or 4 adverse events. Nested pharmacokinetic studies will evaluate anti-tuberculosis drug concentrations, providing model-based predictions for optimal dosing, and measure antiretroviral exposures in order to describe the drug-drug interactions in a subset of HIV-infected children. Socioeconomic analyses will evaluate the cost-effectiveness of the intervention and social science studies will further explore the acceptability and palatability of these new paediatric drug formulations. Although recent trials of TB treatment-shortening in adults with sputum-positivity have not been successful, the question has never been addressed in children, who have mainly paucibacillary, non-severe smear-negative disease. SHINE should inform whether treatment-shortening of drug-susceptible TB in children, regardless of HIV status, is efficacious and safe. The trial will also fill existing gaps in knowledge on dosing and acceptability of new anti-tuberculosis formulations and commonly used HIV drugs in settings with a high burden of TB. A positive result from this trial could simplify and shorten treatment, improve adherence and be cost-saving for many children with TB. Recruitment to the SHINE trial begun in July 2016; results are expected in 2020. International Standard Randomised Controlled Trials Number: ISRCTN63579542 , 14 October 2014. Pan African Clinical Trials Registry Number: PACTR201505001141379 , 14 May 2015. Clinical Trial Registry-India, registration number: CTRI/2017/07/009119, 27 July 2017.

Happy Despite Pain: A Randomized Controlled Trial of an 8-Week Internet-delivered Positive Psychology Intervention for Enhancing Well-being in Patients With Chronic Pain.

PubMed

Peters, Madelon L; Smeets, Elke; Feijge, Marion; van Breukelen, Gerard; Andersson, Gerhard; Buhrman, Monica; Linton, Steven J

2017-11-01

There is preliminary evidence for the efficacy of positive psychology interventions for pain management. The current study examined the effects of an internet-based positive psychology self-help program for patients with chronic musculoskeletal pain and compared it with an internet-based cognitive-behavioral program. A randomized controlled trial was carried out with 3 conditions: an internet-delivered positive psychology program, an internet-delivered cognitive-behavioral program and waitlist control. A total of 276 patients were randomized to 1 of the 3 conditions and posttreatment data were obtained from 206 patients. Primary outcomes were happiness, depression, and physical impairments at posttreatment and at 6-month follow-up. Intention-to-treat analyses were carried out using mixed regression analyses. Both treatments led to significant increases in happiness and decreases in depression. Physical impairments did not significantly decrease compared with waitlist. Improvements in happiness and depression were maintained until 6-month follow-up. There were no overall differences in the efficacy of the 2 active interventions but effects seemed to be moderated by education. Patients with a higher level of education profited slightly more from the positive psychology intervention than from the cognitive-behavioral program. The results suggest that an internet-based positive psychology and cognitive-behavioral self-help interventions for the management of chronic pain are clinically useful. Because the self-help exercises as used in the current program do not require therapist involvement, dissemination potential is large. Further studies should examine whether it can best be used as stand-alone or add-on treatment combined with established pain treatment programs.

Exercise to improve self-esteem in children and young people.

PubMed

Ekeland, E; Heian, F; Hagen, K B; Abbott, J; Nordheim, L

2004-01-01

Psychological and behavioural problems in children and adolescents are common, and improving self-esteem may help to prevent the development of such problems. There is strong evidence for the positive physical health outcomes of exercise, but the evidence of exercise on mental health is scarce. To determine if exercise alone or exercise as part of a comprehensive intervention can improve self-esteem among children and young people. Computerised searches in MEDLINE, EMBASE, The Cochrane Controlled Trials Register (CENTRAL), CINAHL, PsycINFO and ERIC were undertaken and reference lists from relevant articles were scanned. Relevant studies were also traced by contacting authors. Dates of most recent searches: May 2003 in (CENTRAL), all others: January 2002. Randomised controlled trials where the study population consisted of children and young people aged from 3 to 20 years, in which one intervention arm was gross motor activity for more than four weeks and the outcome measure was self-esteem. Two reviewers independently selected trials for inclusion, assessed the validity of included trials and extracted data. Investigators were contacted to collect missing data or for clarification when necessary. Twenty-three trials with a total of 1821 children and young people were included. Generally, the trials were small, and only one was assessed to have a low risk of bias. Thirteen trials compared exercise alone with no intervention. Eight were included in the meta-analysis, and overall the results were heteregeneous. One study with a low risk of bias showed a standardised mean difference (SMD) of 1.33 (95% CI 0.43 to 2.23), while the SMD's for the three studies with a moderate risk of bias and the four studies with a high risk of bias was 0.21 (95% CI -0.17 to 0.59) and 0.57 (95% CI 0.11 to 1.04), respectively. Twelve trials compared exercise as part of a comprehensive programme with no intervention. Only four provided data sufficient to calculate overall effects, and the results indicate a moderate short-term difference in self-esteem in favour of the intervention [SMD 0.51 (95% CI 0.15 to 0.88)]. The results indicate that exercise has positive short-term effects on self-esteem in children and young people. Since there are no known negative effects of exercise and many positive effects on physical health, exercise may be an important measure in improving children's self-esteem. These conclusions are based on several small low-quality trials.

Novel fluorescence in situ hybridization-based definition of bacille Calmette-Guérin (BCG) failure for use in enhancing recruitment into clinical trials of intravesical therapies.

PubMed

Kamat, Ashish M; Willis, Daniel L; Dickstein, Rian J; Anderson, Rooselvelt; Nogueras-González, Graciela; Katz, Ruth L; Wu, Xifeng; Barton Grossman, H; Dinney, Colin P

2016-05-01

To present a molecular definition of bacille Calmette-Guérin (BCG) failure that incorporates fluorescence in situ hybridization (FISH) testing to predict BCG failure before it becomes clinically evident, which can be used to enhance trial designs for patients with non-muscle-invasive bladder cancer. We used data from 143 patients who were followed prospectively for 2 years during intravesical BCG therapy, during which time FISH assays were collected and correlated to clinical outcomes. Of the 95 patients with no evidence of tumour at 3-month cystoscopy, 23 developed tumour recurrence and 17 developed disease progression by 2 years. Patients with a positive FISH test at both 6 weeks and 3 months were more likely to develop tumour recurrence (17/37 patients [46%] and 16/28 patients [57%], respectively) than patients with a negative FISH test (6/58 patients [10%] and 3/39 patients [8%], respectively; both P < 0.001). Using hazard ratios for recurrence with positive 6-week and 3-month FISH results, we constructed clinical trial scenarios whereby patients with a negative 3-month cystoscopy and positive FISH result could be considered to have 'molecular BCG failure' and could be enrolled in prospective, randomized clinical trials comparing BCG therapy (control) with an experimental intravesical therapy. Patients with positive early FISH and negative 3-month cystoscopy results can be considered to have molecular BCG failure based on their high rates of recurrence and progression. This definition is intended for use in designing clinical trials, thus potentially allowing continued use of BCG as an ethical comparator arm. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

Optimizing a positive psychology intervention to promote health behaviors following an acute coronary syndrome: The Positive Emotions after Acute Coronary Events-III (PEACE-III) randomized factorial trial.

PubMed

Celano, Christopher M; Albanese, Ariana M; Millstein, Rachel A; Mastromauro, Carol A; Chung, Wei-Jean; Campbell, Kirsti A; Legler, Sean R; Park, Elyse R; Healy, Brian C; Collins, Linda M; Januzzi, James L; Huffman, Jeff C

2018-04-05

Despite the clear benefits of physical activity and related behaviors on prognosis, most patients suffering an acute coronary syndrome (ACS) remain nonadherent to these behaviors. Deficits in positive psychological constructs (e.g., optimism) are linked to reduced participation in health behaviors, supporting the potential utility of a positive psychology (PP)-based intervention in post-ACS patients. Accordingly, we aimed to identify optimal components of a PP-based intervention to promote post-ACS physical activity. As part of a multiphase optimization strategy, we completed a randomized factorial trial with eight conditions in 128 post-ACS patients to efficiently identify best-performing intervention components. All participants received a PP-based intervention, with conditions varying in duration (presence/absence of booster sessions), intensity (weekly/daily PP exercises), and content (PP alone or combined with motivational interviewing [MI]), allowing three concurrent comparisons within the trial. Study aims included assessments of the overall feasibility, acceptability, and impact of the intervention, along with the primary aim of determining which components were associated with objectively-measured physical activity and self-reported health behavior adherence at 16 weeks, assessed using longitudinal models. The intervention was well-accepted and associated with substantial improvements in behavioral and psychological outcomes. Booster sessions were associated with greater activity to a nearly significant degree (β=8.58, 95% confidence interval= -0.49-17.65, effect size difference=.43; p=.064), MI was associated with overall adherence (β=0.95, 95% confidence interval=0.02-1.87, effect size difference=.39; p=.044), and weekly exercise completion was generally superior to daily. These findings will enable optimization of the PP-based intervention in preparation for a well-powered controlled trial. ClinicalTrials.gov identifier: NCT02754895.

Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

PubMed

Labhardt, Niklaus Daniel; Ringera, Isaac; Lejone, Thabo Ishmael; Masethothi, Phofu; Thaanyane, T'sepang; Kamele, Mashaete; Gupta, Ravi Shankar; Thin, Kyaw; Cerutti, Bernard; Klimkait, Thomas; Fritz, Christiane; Glass, Tracy Renée

2016-04-14

Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to improve the care cascade in similar settings. NCT02692027 , registered February 21, 2016.

Trichuris suis ova, lecithin and other fancy molecules.

PubMed

Schölmerich, Jürgen

2014-01-01

During the last 20 years, treatment paradigms as well as drugs used for IBD have changed significantly. However, there are still many unmet needs and a significant number of patients needing better therapy. It is obvious from this situation that many attempts have been made to implement new drugs and treatment algorithms including biologicals, new formulations of old drugs and 'fancy molecules or approaches'. For about 10 years, the application of Trichuris suis ova has been promoted and used in quite a number of patients. Two early studies suggested positive effects in ulcerative colitis as well as in Crohn's disease. These studies were based on experimental data in animal models as well as in vitro experiments. However, two large randomized controlled trials were not able to provide significant clinical effects in active Crohn's disease as compared to placebo, although a biological reaction (eosinophilia) was found. Another approach is the use of locally released phosphatidylcholine in ulcerative colitis. This approach is based on decreased phosphatidylcholine concentrations in the colonic mucus in patients, and showed positive effects in a number of monocentric trials in steroid-refractory and chronic active ulcerative colitis. A dose-finding study gave a positive signal in the highest-dose group and this approach is being tested further in controlled trials. Many other 'fancy molecules' including cannabis, vitamin D, thalidomide, hyaluronic acid, lidocaine, clonidine, chondroitin sulfate, naltrexone and melatonin have been tested in patients with claims of success. For most of those, however, controlled data in appropriate studies are lacking. Many more substances have been used in animal models and are probably applied in individual patients. Results of preliminary studies on some of the molecules mentioned are presented. © 2014 S. Karger AG, Basel.

Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials.

PubMed

Pang, Winnie K; Yeter, Karen C; Torralba, Karina D; Spencer, Horace J; Khan, Nasim A

2015-07-01

To evaluate the association of financial conflicts of interest (FCOI) with the characteristics, outcome and reported methodological quality of fibromyalgia drug therapy randomized controlled trials (FM-RCTs). A cross-sectional study of original, parallel-group, drug therapy FM-RCTs published between 1997 and 2011 from Medline and Cochrane Central Register of Controlled Trials was conducted. Two reviewers independently assessed each RCT for funding source, authors' FCOI(s), study characteristics, reporting of methodological measures important for internal validity and outcome (positive [statistically significant result favoring experimental drug for the primary outcome] or non-positive). Forty-seven RCTs were eligible with funding source as: 26 (55.3%) industry; eight (17%) non-profit source(s); five (10.6%) mixed; and eight (17%) unspecified. Industry-funded RCTs were more likely to be multicenter and enroll greater number of patients. Reporting of key methodological measures was suboptimal; however, industry and non-profit funded RCTs did not differ in their reporting. Thirty (63.8%) RCTs had ≥ one author who disclosed an FCOI (receipt of research grant [21, 44.7%], industry sponsor employee [20, 42.6%], receipt of consultancy fee/honorarium [16, 34%] and stock ownership [11, 23.4%]). Although industry funding and certain authors' FCOIs (employment and receipt of consultancy fee/honorarium) were univariately associated with positive outcome, such association was not observed after adjusting for study sample size. The majority of FM-RCTs were industry-sponsored, and had at least one author with an FCOI. Reporting of key methodological measures was suboptimal. After adjusting for study sample size, no association of industry funding or author's FCOI with study outcome was seen. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Impact and change of attitudes toward Internet interventions within a randomized controlled trial on individuals with depression symptoms.

PubMed

Schröder, Johanna; Berger, Thomas; Meyer, Björn; Lutz, Wolfgang; Späth, Christina; Michel, Pia; Rose, Matthias; Hautzinger, Martin; Hohagen, Fritz; Klein, Jan Philipp; Moritz, Steffen

2018-05-01

Most individuals with depression do not receive adequate treatment. Internet interventions may help to bridge this gap. Research on attitudes toward Internet interventions might facilitate the dissemination of such interventions by identifying factors that help or hinder uptake and implementation, and by clarifying who is likely to benefit. This study examined whether attitudes toward Internet interventions moderate the effects of a depression-focused Internet intervention, and how attitudes change over the course of treatment among those who do or do not benefit. We recruited 1,004 adults with mild-to-moderate depression symptoms and investigated how attitudes toward Internet interventions are associated with the efficacy of the program deprexis, and how attitudes in the intervention group change from pre to post over a 3 months intervention period, compared to a control group (care as usual). This study consists of a subgroup analysis of the randomized controlled EVIDENT trial. Positive initial attitudes toward Internet interventions were associated with greater efficacy (η 2 p  = .014) independent of usage time, whereas a negative attitude (perceived lack of personal contact) was associated with reduced efficacy (η 2 p  = .012). Users' attitudes changed during the trial, and both the magnitude and direction of attitude change were associated with the efficacy of the program over time (η 2 p  = .030). Internet interventions may be the most beneficial for individuals with positive attitudes toward them. Informing potential users about evidence-based Internet interventions might instill positive attitudes and thereby optimize the benefits such interventions can provide. Assessing attitudes prior to treatment might help identify suitable users. © 2018 Wiley Periodicals, Inc.

Usability research study of a specially engineered sonic powered toothbrush with unique sensing and control technologies.

PubMed

Hunter, Gail; Burns, Laurie; Bone, Brian; Mintel, Thomas; Jimenez, Eduardo

2012-01-01

This paper summarizes the results of a longitudinal usability research study of a specially engineered sonic powered toothbrush with unique sensing and control technologies. The usability test was conducted with fourteen (14) consumers from the St. Louis, MO, USA area who use manual toothbrushes. The study consisted of consumers using the specially engineered sonic powered toothbrush with unique sensing and control technologies for three weeks. During the study, users participated in four toothbrush trials during weekly visits to the research facility. These trials were videotaped and were analyzed regarding brushing time, behavior, and technique. In addition, the users were required to use the toothbrush twice a day for their at-home brushing. The toothbrush had a positive impact on consumers' tooth brushing behavior. Users spent more time brushing their teeth with this toothbrush as compared to their manual toothbrush. In addition, users spent more time keeping the sonic toothbrush in the recommended angle during use. Finally, users perceived their teeth to be cleaner when using the specially engineered sonic powered toothbrush with unique sensing and control technologies. The specially engineered sonic powered toothbrush with unique sensing and control technologies left a positive impression on the users. The users perceived the toothbrush to clean their teeth better than a manual toothbrush.

Impact of the project P.A.T.H.S. In the junior secondary school years: individual growth curve analyses.

PubMed

Shek, Daniel T L; Ma, Cecilia M S

2011-02-03

The Tier 1 Program of the Project P.A.T.H.S. (Positive Adolescent Training through Holistic Social Programs) is a positive youth development program implemented in school settings utilizing a curricular-based approach. In the third year of the Full Implementation Phase, 19 experimental schools (n = 3,006 students) and 24 control schools (n = 3,727 students) participated in a randomized group trial. Analyses based on linear mixed models via SPSS showed that participants in the experimental schools displayed better positive youth development than did participants in the control schools based on different indicators derived from the Chinese Positive Youth Development Scale, including positive self-identity, prosocial behavior, and general positive youth development attributes. Differences between experimental and control participants were also found when students who joined the Tier 1 Program and perceived the program to be beneficial were employed as participants of the experimental schools. The present findings strongly suggest that the Project P.A.T.H.S. is making an important positive impact for junior secondary school students in Hong Kong.

Clinical Trials of Blood Pressure Lowering and Antihypertensive Medication: Is Cognitive Measurement State-of-the-Art?

PubMed

Elias, Merrill F; Torres, Rachael V; Davey, Adam

2018-05-07

Randomized controlled trials of blood pressure (BP) lowering and antihypertensive medication use on cognitive outcomes have often been disappointing, reporting mixed findings and small effect sizes. We evaluate the extent to which cognitive assessment protocols used in these trials approach state-of-the-art. Overall, we find that a primary focus on cognition and the systematic selection of cognitive outcomes across trials take a backseat to other trial goals. Twelve trials investigating change in cognitive functioning were examined and none met criteria for state-of-the-art assessment, including use of at least 4 tests indexing 2 cognitive domains. Four trials investigating incident dementia were also examined. Each trial used state-of-the-art diagnostic criteria to assess dementia, although follow-up periods were relatively short, with only 2 trials lasting for at least 3 years. Weaknesses in each trial may act to obscure or weaken the positive effects of BP lowering on cognitive functioning. Improving trial designs in terms of cognitive outcomes selected and length of follow-up periods employed could lead to more promising findings. We offer logical steps to achieve state-of-the-art assessment protocols, with examples, in hopes of improving future trials.

Do Menstrual Hygiene Management Interventions Improve Education and Psychosocial Outcomes for Women and Girls in Low and Middle Income Countries? A Systematic Review

PubMed Central

Hennegan, Julie; Montgomery, Paul

2016-01-01

Background Unhygienic and ineffective menstrual hygiene management has been documented across low resource contexts and linked to negative consequences for women and girls. Objectives To summarise and critically appraise evidence for the effectiveness of menstruation management interventions in improving women and girls’ education, work and psychosocial wellbeing in low and middle income countries. Methods Structured systematic searches were conducted in peer-reviewed and grey literature to identify studies evaluating education and resource provision interventions for menstruation management. Individual and cluster randomised controlled trials were eligible for inclusion, as were non-randomised controlled trials. Study characteristics, outcomes and risk of bias were extracted using a piloted form. Risk of bias was independently assessed by two researchers. Results Eight studies described in ten citations were eligible for inclusion. Studies were highly heterogeneous in design and context. Six included assessment of education-only interventions, and three provided assessment of the provision of different types of sanitary products (menstrual cups, disposable sanitary pads, and reusable sanitary pads). A moderate but non-significant standardised mean difference was found for the two studies assessing the impact of sanitary pad provision on school attendance: 0.49 (95%CI -0.13, 1.11). Included studies were heterogeneous with considerable risk of bias. Trials of education interventions reported positive impacts on menstrual knowledge and practices, however, many studies failed to assess other relevant outcomes. No trials assessed or reported harms. Conclusions There is insufficient evidence to establish the effectiveness of menstruation management interventions, although current results are promising. Eight trials have been conducted, but a high risk of bias was found and clinical heterogeneity precluded synthesis of most results. Whilst trials provided some indication of positive results, further research is needed to establish the role of menstruation hygiene management in education performance, employment and other psychosocial outcomes. This review provides a concise summary of present trials and highlights improvements for future work. PMID:26862750

Do Menstrual Hygiene Management Interventions Improve Education and Psychosocial Outcomes for Women and Girls in Low and Middle Income Countries? A Systematic Review.

PubMed

Hennegan, Julie; Montgomery, Paul

2016-01-01

Unhygienic and ineffective menstrual hygiene management has been documented across low resource contexts and linked to negative consequences for women and girls. To summarise and critically appraise evidence for the effectiveness of menstruation management interventions in improving women and girls' education, work and psychosocial wellbeing in low and middle income countries. Structured systematic searches were conducted in peer-reviewed and grey literature to identify studies evaluating education and resource provision interventions for menstruation management. Individual and cluster randomised controlled trials were eligible for inclusion, as were non-randomised controlled trials. Study characteristics, outcomes and risk of bias were extracted using a piloted form. Risk of bias was independently assessed by two researchers. Eight studies described in ten citations were eligible for inclusion. Studies were highly heterogeneous in design and context. Six included assessment of education-only interventions, and three provided assessment of the provision of different types of sanitary products (menstrual cups, disposable sanitary pads, and reusable sanitary pads). A moderate but non-significant standardised mean difference was found for the two studies assessing the impact of sanitary pad provision on school attendance: 0.49 (95%CI -0.13, 1.11). Included studies were heterogeneous with considerable risk of bias. Trials of education interventions reported positive impacts on menstrual knowledge and practices, however, many studies failed to assess other relevant outcomes. No trials assessed or reported harms. There is insufficient evidence to establish the effectiveness of menstruation management interventions, although current results are promising. Eight trials have been conducted, but a high risk of bias was found and clinical heterogeneity precluded synthesis of most results. Whilst trials provided some indication of positive results, further research is needed to establish the role of menstruation hygiene management in education performance, employment and other psychosocial outcomes. This review provides a concise summary of present trials and highlights improvements for future work.

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

PubMed

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

2013-05-01

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

Emotional and uncontrolled eating styles and chocolate chip cookie consumption. A controlled trial of the effects of positive mood enhancement.

PubMed

Turner, Sally Ann; Luszczynska, Aleksandra; Warner, Lisa; Schwarzer, Ralf

2010-02-01

The study tested the effects of positive mood enhancement on chocolate chip cookie consumption in the context of emotional and uncontrolled eating styles. The relationship between emotional eating style and chocolate chip cookie intake was assumed to be mediated by uncontrolled eating style. Further, it was hypothesized that the effectiveness of the positive mood enhancement may be more salient among those who have effective control of their eating. In this experimental study, respondents (N=106, 70% women, aged 16-45 years old) were assigned by means of cluster randomization to the control or positive mood enhancement condition (a comedy movie clip). Compared to the control condition, positive mood enhancement resulted in consuming on average 53.86 kcal less. Relationships between emotional eating style and cookie intake were mediated by uncontrolled eating. Moderated mediation analysis indicated that the effect of a mediator (uncontrolled eating) on cookie intake was moderated by the group assignment. Positive mood enhancement resulted in eating on average 3.3 cookies less among individuals with a more controlled eating style. By contrast, among those who presented uncontrolled eating, positive mood enhancement led to consuming an average of 1.7 cookies more. 2009 Elsevier Ltd. All rights reserved.

Study of ecologo-biological reactions of common flax to finely dispersed metallurgical wastes

NASA Astrophysics Data System (ADS)

Zakharova, O.; Gusev, A.; Skripnikova, E.; Skripnikova, M.; Krutyakov, Yu; Kudrinsky, A.; Mikhailov, I.; Senatova, S.; Chuprunov, C.; Kuznetsov, D.

2015-11-01

Study was carried out on the influence of metallurgic industrial sludge on morphometric and biochemical indicators as well as productivity of common flax under laboratory and field conditions. In laboratory settings negative influence on seed germinating ability and positive influence on sprouts biomass production in water medium were observed. In sand medium suppression of biological productivity under the influence of sludge together with photosynthetic system II (FS II) activity stimulation were registered. Biochemical study showed peroxidase activity decrease in laboratory, while activity of polyphenol oxidase, superoxide dismutase and catalase were given a mild boost under the influence of sludge. In the field trial, positive influence of sludge on flax photosynthetic apparatus was shown. Positive influence of sludge on vegetation and yield indicators was observed. The analysis of heavy metals content showed excess over maximum allowable concentration (MAC) of copper and zinc in control plants, it may point to the background soil pollution. In the plants from the trial groups receiving 0.5 and 2 ton/ha heavy metals content below the control values was registered. Application of 4 ton/ha led to the maximum content of copper and zinc in the plants among the trial groups. The analysis of soils from the test plots indicated no excess over maximum allowable concentrations of heavy metals. Thus, further study of possibilities of using metallurgic industrial sludge as a soil stimulator in flax cultivation at the application rate of 0.5 t/ha seems promising.

SA19. N-Acetyl-Cysteine in a Double-Blind Randomized Placebo-Controlled Trial: Toward Biomarker-Guided Treatment in Early Psychosis

PubMed Central

Do, Kim; Seidman, Larry J.; Fournier, Margot; Xin, Lijing; Cleusix, Martine; Baumann, Philipp S.; Ferrari, Carina; Cousins, Ann; Alameda, Luis; Gholam-Rezaee, Mehdi; Golay, Philippe; Jenni, Raoul; Woo, T-U Wilson; Keshavan, Matcheri S.; Eap, Chin B.; Wojcik, Joanne; Cuenod, Michel; Buclin, Thierry; Gruetter, Rolf; Conus, Philippe

2017-01-01

Abstract Background: Biomarker-guided treatments are needed in psychiatry and previous data suggest redox dysregulation / oxidative stress may be a target in schizophrenia (1,2). A previous add-on trial with the antioxidant N-Acetyl-Cysteine (NAC) led to negative symptoms reductions in chronic patients (3). We aim to study NAC impact on symptoms and neurocognition in early psychosis (EP) and to explore whether glutathione (GSH)/redox markers could represent valid biomarkers to guide treatment. Methods: In a double-blind, randomized, placebo-controlled trial in 63 EP patients, we assessed the effect of NAC supplementation (2700 mg/day, 6 months) on PANSS, neurocognition (MATRICS Consensus Cognitive Battery [MCCB]), and redox markers (brain GSH [GSH-mPFC], blood cells GSH [GSH-BC] levels, and GSH peroxidase activity [GPx-BC]). Results: No changes in negative, positive symptoms, or functional outcome were observed with NAC, but significant improvements were found in favor of NAC on the MCCB Processing Speed factor and two of its components: Trail Making and Verbal Fluency. NAC leads to increases in GSH-mPFC by 23% (P = .005) and GSH-BC by 19% (P = .05). In patients with high-baseline GPx-BC (>22.3U/gHb), subgroup explorations revealed an improvement with NAC of positive symptoms when compared to patients with low-baseline GPx (P = .02), with an improvement of positive symptoms in parallel with that of the redox status. Conclusion: In conclusion, NAC supplementation in a limited sample of EP patients did not improve negative symptoms, which were at modest levels at baseline. However, NAC leads to neurocognition improvement as well as to brain GSH levels increases, pointing to good target engagement. Blood GPx activity, a redox peripheral index associated with brain GSH levels, could help to identify a subgroup of patients who improve their positive symptoms with NAC. Future trials with antioxidant in EP should consider biomarker-guided treatment. References 1. Steullet P et al. 2016, Redox dysregulation, neuroinflammation, and NMDA receptor hypofunction: A “central hub” in schizophrenia pathophysiology? Schizophr Res. 176:41. 2. Hardingham GE, Do KQ, 2016, Linking early-life NMDAR hypofunction and oxidative stress in schizophrenia pathogenesis. Nat Rev Neurosci. 17:125. 3. Berk M et al. 2008, N-acetyl cysteine as a glutathione precursor for schizophrenia--a double-blind, randomized, placebo-controlled trial. Biol Psychiatry, 64:361.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

PubMed Central

Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2017-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014–2015 school year. The study’s rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area. PMID:28936104

Neighborhood effects in a behavioral randomized controlled trial.

PubMed

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

2014-11-01

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=5628), 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. Copyright © 2014 Elsevier Ltd. All rights reserved.

Luteinising hormone releasing hormone for incomplete descent of the testis.

PubMed Central

Klidjian, A M; Swift, P G; Johnstone, J M

1985-01-01

Forty boys with 54 incompletely descended testes took part in a double blind, controlled trial of intranasal luteinising hormone releasing hormone. In the control (placebo) group of 18 boys there was no significant change in testicular descent and all required orchidopexy; in the 22 treated boys, however, 12 of 29 testes (42%) were found in a lower position. This study supports the idea that a trial of intranasal luteinising hormone releasing hormone (1200 micrograms/day for 28 days) will help clarify the need for orchidopexy in at least 30% of boys with incomplete descent of the testis, particularly those in whom the testes have emerged from the inguinal canal. PMID:2861791

Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial.

PubMed

Poslawsky, Irina E; Naber, Fabiënne Ba; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

2015-07-01

In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child interaction and reducing the child's individual Autism Spectrum Disorder-related symptomatology in five home visits. VIPP-AUTI, as compared with usual care, demonstrated efficacy in reducing parental intrusiveness. Moreover, parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing. No significant group differences were found on other aspects of parent-child interaction or on child play behavior. At 3-months follow-up, intervention effects were found on child-initiated joint attention skills, not mediated by intervention effects on parenting. Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners. © The Author(s) 2014.

A randomized-control trial for the teachers' diploma programme on psychosocial care, support and protection in Zambian government primary schools.

PubMed

Kaljee, Linda; Zhang, Liying; Langhaug, Lisa; Munjile, Kelvin; Tembo, Stephen; Menon, Anitha; Stanton, Bonita; Li, Xiaoming; Malungo, Jacob

2017-04-01

Orphaned and vulnerable children (OVC) experience poverty, stigma, and abuse resulting in poor physical, emotional, and psychological outcomes. The Teachers' Diploma Programme on Psychosocial Care, Support, and Protection is a child-centered 15-month long-distance learning program focused on providing teachers with the knowledge and skills to enhance their school environments, foster psychosocial support, and facilitate school-community relationships. A randomized controlled trial was implemented in 2013-2014. Both teachers (n=325) and students (n=1378) were assessed at baseline and 15-months post-intervention from randomly assigned primary schools in Lusaka and Eastern Provinces, Zambia. Multilevel linear mixed models (MLM) indicate positive significant changes for intervention teachers on outcomes related to self-care, teaching resources, safety, social support, and gender equity. Positive outcomes for intervention students related to future orientation, respect, support, safety, sexual abuse, and bullying. Outcomes support the hypothesis that teachers and students benefit from a program designed to enhance teachers' psychosocial skills and knowledge.

Impact on learning of an e-learning module on leukaemia: a randomised controlled trial.

PubMed

Morgulis, Yuri; Kumar, Rakesh K; Lindeman, Robert; Velan, Gary M

2012-05-28

e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group's evaluation of the module was overwhelmingly positive. A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines.

Improving Elementary School Quality Through the Use of a Social-Emotional and Character Development Program: A Matched-Pair, Cluster-Randomized, Controlled Trial in Hawai’i

PubMed Central

Snyder, Frank J.; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J.; Flay, Brian R.

2012-01-01

BACKGROUND School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai’i trial included 20 racially/ethnically diverse schools and was conducted from 2002–2003 through 2005–2006. METHODS School-level archival data, collected by the Hawai’i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. RESULTS Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. CONCLUSIONS School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. PMID:22142170

Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i.

PubMed

Snyder, Frank J; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J; Flay, Brian R

2012-01-01

School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools and was conducted from 2002-2003 through 2005-2006. School-level archival data, collected by the Hawai'i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. © 2011, American School Health Association.

The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial.

PubMed

Lu, Jun-Yang; Xu, Lai; Xue, Hua-Dan; Zhou, Wei-Xun; Xu, Tao; Qiu, Hui-Zhong; Wu, Bin; Lin, Guo-Le; Xiao, Yi

2016-12-08

The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted and increasingly applied by colorectal surgeons. The aim of this study is to investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve the oncological outcomes of patients with right-sided colon cancers, compared with D2 lymphadenectomy. The Radical Extent of lympadenectomy: D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) study is a prospective, multicenter, randomized controlled trial in which 1072 eligible patients with right-sided colon cancers will be randomly assigned to the CME group or the D2 dissection group during laparoscopic right colectomy. Inclusion criteria are locally advanced colon cancers situated from the cecum to the right third of the transverse colon and clinically staged as T2-4aN0M0 or TanyN + M0. The primary endpoint of this trial is 3-year disease-free survival. Secondary endpoints include 3-year overall survival, postoperative complication rates, perioperative mortality rates, and rates of positive central lymph nodes (the station 3 nodes). The RELARC trial is a prospective, multicenter, randomized controlled trial that will provide evidence on the optimal extent of lymphadenectomy during laparoscopic right colectomy in terms of better oncological outcome and operation safety. ClinicalTrials.gov: NCT02619942 . Registered on 29 November 2015.

Enhancing Cognitive and Social-Emotional Development through a Simple-to-Administer Mindfulness-Based School Program for Elementary School Children: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Schonert-Reichl, Kimberly A.; Oberle, Eva; Lawlor, Molly Stewart; Abbott, David; Thomson, Kimberly; Oberlander, Tim F.; Diamond, Adele

2015-01-01

The authors hypothesized that a social and emotional learning (SEL) program involving mindfulness and caring for others, designed for elementary school students, would enhance cognitive control, reduce stress, promote well-being and prosociality, and produce positive school outcomes. To test this hypothesis, 4 classes of combined 4th and 5th…

Exercise rehabilitation following intensive care unit discharge for recovery from critical illness: executive summary of a Cochrane Collaboration systematic review.

PubMed

Connolly, Bronwen; Salisbury, Lisa; O'Neill, Brenda; Geneen, Louise; Douiri, Abdel; Grocott, Michael P W; Hart, Nicholas; Walsh, Timothy S; Blackwood, Bronagh

2016-12-01

Skeletal muscle wasting and weakness are major complications of critical illness and underlie the profound physical and functional impairments experienced by survivors after discharge from the intensive care unit (ICU). Exercise-based rehabilitation has been shown to be beneficial when delivered during ICU admission. This review aimed to determine the effectiveness of exercise rehabilitation initiated after ICU discharge on primary outcomes of functional exercise capacity and health-related quality of life. We sought randomized controlled trials, quasi-randomized controlled trials, and controlled clinical trials comparing an exercise intervention commenced after ICU discharge vs. any other intervention or a control or 'usual care' programme in adult survivors of critical illness. Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database, and Cumulative Index to Nursing and Allied Health Literature databases were searched up to February 2015. Dual, independent screening of results, data extraction, and quality appraisal were performed. We included six trials involving 483 patients. Overall quality of evidence for both outcomes was very low. All studies evaluated functional exercise capacity, with three reporting positive effects in favour of the intervention. Only two studies evaluated health-related quality of life and neither reported differences between intervention and control groups. Meta-analyses of data were precluded due to variation in study design, types of interventions, and selection and reporting of outcome measurements. We were unable to determine an overall effect on functional exercise capacity or health-related quality of life of interventions initiated after ICU discharge for survivors of critical illness. Findings from ongoing studies are awaited. Future studies need to address methodological aspects of study design and conduct to enhance rigour, quality, and synthesis.

A Systematic Review of the Effectiveness of Medical Cannabis for Psychiatric, Movement and Neurodegenerative Disorders.

PubMed

Lim, Keane; See, Yuen Mei; Lee, Jimmy

2017-11-30

The discovery of endocannabinoid's role within the central nervous system and its potential therapeutic benefits have brought forth rising interest in the use of cannabis for medical purposes. The present review aimed to synthesize and evaluate the available evidences on the efficacy of cannabis and its derivatives for psychiatric, neurodegenerative and movement disorders. A systematic search of randomized controlled trials of cannabis and its derivatives were conducted via databases (PubMed, Embase and the Cochrane Central Register of Controlled Trials). A total of 24 reports that evaluated the use of medical cannabis for Alzheimer's disease, anorexia nervosa, anxiety, dementia, dystonia, Huntington's disease, Parkinson's disease, post-traumatic stress disorder (PTSD), psychosis and Tourette syndrome were included in this review. Trial quality was assessed with the Cochrane risk of bias tool. There is a lack of evidence on the therapeutic effects of cannabinoids for amyotrophic lateral sclerosis and dystonia. Although trials with positive findings were identified for anorexia nervosa, anxiety, PTSD, psychotic symptoms, agitation in Alzheimer's disease and dementia, Huntington's disease, and Tourette syndrome, and dyskinesia in Parkinson's disease, definitive conclusion on its efficacy could not be drawn. Evaluation of these low-quality trials, as rated on the Cochrane risk of bias tools, was challenged by methodological issues such as inadequate description of allocation concealment, blinding and underpowered sample size. More adequately powered controlled trials that examine the long and short term efficacy, safety and tolerability of cannabis for medical use, and the mechanisms underpinning the therapeutic potential are warranted.

For Whom Does It Work? Moderators of Outcome on the Effect of a Transdiagnostic Internet-Based Maintenance Treatment After Inpatient Psychotherapy: Randomized Controlled Trial

PubMed Central

Gollwitzer, Mario; Riper, Heleen; Cuijpers, Pim; Baumeister, Harald; Berking, Matthias

2013-01-01

Background Recent studies provide evidence for the effectiveness of Internet-based maintenance treatments for mental disorders. However, it is still unclear which participants might or might not profit from this particular kind of treatment delivery. Objective The study aimed to identify moderators of treatment outcome in a transdiagnostic Internet-based maintenance treatment (TIMT) offered to patients after inpatient psychotherapy for mental disorders in routine care. Methods Using data from a randomized controlled trial (N=400) designed to test the effectiveness of TIMT, we performed secondary analyses to identify factors moderating the effects of TIMT (intervention) when compared with those of a treatment-as-usual control condition. TIMT involved an online self-management module, asynchronous patient–therapist communication, a peer support group, and online-based progress monitoring. Participants in the control condition had unstructured access to outpatient psychotherapy, standardized outpatient face-to-face continuation treatment, and psychotropic management. Self-reports of psychopathological symptoms and potential moderators were assessed at the start of inpatient treatment (T1), at discharge from inpatient treatment/start of TIMT (T2), and at 3-month (T3) and 12-month follow-up (T4). Results Education level, positive outcome expectations, and diagnoses significantly moderated intervention versus control differences regarding changes in outcomes between T2 and T3. Only education level moderated change differences between T2 and T4. The effectiveness of the intervention (vs control) was more pronounced among participants with a low (vs high) education level (T2-T3: B=–0.32, SE 0.16, P=.049; T2-T4: B=–0.42, SE 0.21, P=.049), participants with high (vs low) positive outcome expectations (T2-T3: B=–0.12, SE 0.05, P=.02) and participants with anxiety disorder (vs mood disorder) (T2-T3: B=–0.43, SE 0.21, P=.04). Simple slope analyses revealed that despite some subgroups benefiting less from the intervention than others, all subgroups still benefited significantly. Conclusions This transdiagnostic Internet-based maintenance treatment might be suitable for a wide range of participants differing in various clinical, motivational, and demographic characteristics. The treatment is especially effective for participants with low education levels. These findings may generalize to other Internet-based maintenance treatments. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 28632626; http://www.controlled-trials.com/isrctn/pf/28632626 (Archived by WebCite at http://www.webcitation.org/6IqZjTLrx). PMID:24113764

'The trial is owned by the team, not by an individual': a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology.

PubMed

Strong, Sean; Paramasivan, Sangeetha; Mills, Nicola; Wilson, Caroline; Donovan, Jenny L; Blazeby, Jane M

2016-04-26

Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties. Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently. Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner. This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs. International Standard Randomised Controlled Trial Number (ISRCTN): ISRCTN89052791 .

The Helicobacter Eradication Aspirin Trial (HEAT): A Large Simple Randomised Controlled Trial Using Novel Methodology in Primary Care.

PubMed

Dumbleton, Jennifer S; Avery, Anthony J; Coupland, Carol; Hobbs, F D Richard; Kendrick, Denise; Moore, Michael V; Morris, Clive; Rubin, Greg P; Smith, Murray D; Stevenson, Diane J; Hawkey, Chris J

2015-09-01

Clinical trials measuring the effect of an intervention on clinical outcomes are more influential than those investigating surrogate measures but are costly. We developed methods to reduce costs substantially by using existing data in primary care systems, to ask whether Helicobacter pylori eradication would reduce the incidence of hospitalisation for ulcer bleeding in aspirin users. The Helicobacter Eradication Aspirin Trial (HEAT) is a National Institute of Health Research-funded, double-blind placebo controlled randomised trial of the effects of H. pylori eradication on subsequent ulcer bleeding in infected individuals taking aspirin daily, conducted in practices across the whole of England, Wales and Northern Ireland. A bespoke web-based trial management system developed for the trial (and housed within the secure NHS Data Network) communicates directly with the HEAT Toolkit software downloaded at participating practices, which issues queries searching entry criteria (≥ 60 years, on chronic aspirin ≤ 325 mg daily, not on anti-ulcer therapy or non-steroidal anti-inflammatory drugs) for GP review of eligibility. Trial participation is invited using a highly secure automated online mail management system. Interested patients are seen once for consent and breath testing. Those with a positive test are randomised to eradication treatment (lansoprazole, clarithromycin, metronidazole) or placebo, with drug sent by post. Events are tracked by upload of accumulating information in the GP database, patient contact, review of National Hospital Episode Statistics and Office of National Statistics data. HEAT is the largest Clinical Research Network-supported drug trial, with 115,660 invitation letters sent from 850 practices, 22,922 volunteers, and 3038 H. pylori positive patients randomised to active or placebo treatment after 2.5 years of recruitment. 178 practices have performed their first follow-up data search to identify 21 potential endpoints to date. HEAT is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.

Moxibustion and other acupuncture point stimulation methods to treat breech presentation: a systematic review of clinical trials

PubMed Central

Li, Xun; Hu, Jun; Wang, Xiaoyi; Zhang, Huirui; Liu, Jianping

2009-01-01

Background Moxibustion, acupuncture and other acupoint stimulations are commonly used for the correction of breech presentation. This systematic review aims to evaluate the efficacy and safety of moxibustion and other acupoint stimulations to treat breech presentation. Methods We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on moxibustion, acupuncture or any other acupoint stimulating methods for breech presentation in pregnant women. All searches in PubMed, the Cochrane Library (2008 Issue 2), China National Knowledge Information (CNKI), Chinese Scientific Journal Database (VIP) and WanFang Database ended in July 2008. Two authors extracted and analyzed the data independently. Results Ten RCTs involving 2090 participants and seven CCTs involving 1409 participants were included in the present study. Meta-analysis showed significant differences between moxibustion and no treatment (RR 1.35, 95% CI 1.20 to 1.51; 3 RCTs). Comparison between moxibustion and knee-chest position did not show significant differences (RR 1.30, 95% CI 0.95 to 1.79; 3 RCTs). Moxibustion plus other therapeutic methods showed significant beneficial effects (RR 1.36, 95% CI 1.21 to 1.54; 2 RCTs). Laser stimulation was more effective than assuming the knee-chest position plus pelvis rotating. Moxibustion was more effective than no treatment (RR 1.29, 95% CI 1.17 to 1.42; 2 CCTs) but was not more effective than the knee-chest position treatment (RR 1.22, 95% CI 1.11 to 1.34; 2 CCTs). Laser stimulation at Zhiyin (BL67) was more effective than the knee-chest position treatment (RR 1.30, 95% CI 1.10 to 1.54; 2 CCTs,). Conclusion Moxibustion, acupuncture and laser acupoint stimulation tend to be effective in the correction of breech presentation. PMID:19245719

CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women.

PubMed

Morisada, Tohru; Teramoto, Katsuhiro; Takano, Hirokuni; Sakamoto, Ikuko; Nishio, Hiroshi; Iwata, Takashi; Hashi, Akihiko; Katoh, Ryohei; Okamoto, Aikou; Sasaki, Hiroshi; Nakatani, Eiji; Teramukai, Satoshi; Aoki, Daisuke

2017-10-01

To assess the efficacy of screening with concurrent liquid-based cytology and human papillomavirus (HPV) testing for primary cervical cancer screening, we initiated a randomized trial entitled CervIcal cancer screening Trial by Randomization of HPV testing intervention for Upcoming Screening (CITRUS). Between June 2013 and March 2015, women aged 30-64 years of age who participated in a regular cervical cancer screening program (every 2 years) were invited to enrollment of our study. After giving their informed consent, 18,402 women were randomly assigned to liquid-based cytology as the control group (n=9145) or to HPV DNA testing with liquid-based cytology as the intervention group (n=9257). We subsequently compared the incidence rate of cervical intraepithelial neoplasia (CIN), the rate of false positive tests and the rate of overdiagnosis, as well as assessing the risks and benefits of receiving screening for women in both groups. The primary outcome of our study was the incidence of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) during the study period of around 6 years. In the control group, 97.9% of women were NILM, and 2.06% ASC-US or worse (ASC-US+). In the intervention group, 87.13% of women were NILM/HPV negative, 0.72% ASC-US/HPV negative, 10.34% NILM/HPV positive, 0.69% ASC-US/HPV positive, 0.90% worse than ASC-US/either HPV. Positive HPV testing was not linearly related to age in our study. Insights from CITRUS will provide future prospects for cervical cancer screening focused on the use of HPV testing in Japan. NCT01895517, UMIN000010843, TRIUC1312. Copyright © 2017 Elsevier Ltd. All rights reserved.

Reporting of embryo transfer methods in IVF research: a cross-sectional study.

PubMed

Gambadauro, Pietro; Navaratnarajah, Ramesan

2015-02-01

The reporting of embryo transfer methods in IVF research was assessed through a cross-sectional analysis of randomized controlled trials (RCTs) published between 2010 and 2011. A systematic search identified 325 abstracts; 122 RCTs were included in the study. Embryo transfer methods were described in 42 out of 122 articles (34%). Catheters (32/42 [76%]) or ultrasound guidance (31/42 [74%]) were most frequently mentioned. Performer 'blinding' (12%) or technique standardization (7%) were seldom reported. The description of embryo transfer methods was significantly more common in trials published by journals with lower impact factor (less than 3, 39.6%; 3 or greater, 21.5%; P = 0.037). Embryo transfer methods were reported more often in trials with pregnancy as the main end-point (33% versus 16%) or with positive outcomes (37.8% versus 25.0%), albeit not significantly. Multivariate logistic regression confirmed that RCTs published in higher impact factor journals are less likely to describe embryo transfer methods (OR 0.371; 95% CI 0.143 to 0.964). Registered trials, trials conducted in an academic setting, multi-centric studies or full-length articles were not positively associated with embryo transfer methods reporting rate. Recent reports of randomized IVF trials rarely describe embryo transfer methods. The under-reporting of research methods might compromise reproducibility and suitability for meta-analysis. Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Vitamin E for the treatment of children with hepatitis B e antigen-positive chronic hepatitis: A systematic review and meta-analysis

PubMed Central

Fiorino, Sirio; Bacchi-Reggiani, Maria Letizia; Leandri, Paolo; Loggi, Elisabetta; Andreone, Pietro

2017-01-01

AIM To assess vitamin E efficacy, defined as its ability to induce hepatitis B e antigen (HBeAg) seroconversion, in children with HBeAg-positive persistent hepatitis. METHODS In July 2016, we extracted articles published in MEDLINE and the Cochrane Library using the following search terms: “chronic hepatitis B”, “children”, “childhood”, “therapy”, “treatment”, “vitamin E”, “tocopherols”, “tocotrienols”. Only randomized controlled trials (RCTs) published in English language were collected. RESULTS Three RCTs met inclusion criteria and were considered in the present meta-analysis. Overall, 23/122 children in the treatment group underwent HBeAg seroconversion vs 3/74 in the control group (OR = 3.96, 95%CI: 1.18-13.25, P = 0.025). CONCLUSION Although our meta-analysis has several limits, including the very small number of available studies and enrolled children with HBeAg positivity-related hepatitis, it suggests that vitamin E use may enhance the probability to induce HBeAg seroconversion in these patients. Further well designed and adequately sized trials are required to confirm or deny these very preliminary results. PMID:28293383

Early Intervention for Preterm Infants and Their Mothers: A Systematic Review.

PubMed

Zhang, Xin; Kurtz, Melissa; Lee, Shih-Yu; Liu, Huaping

2014-11-18

This systematic review evaluates the efficacy of various early interventions on maternal emotional outcomes, mother-infant interaction, and subsequent infant outcomes during neonatal intensive care unit admission and postdischarge. Key interventions associated with outcomes in both the neonatal intensive care unit and postdischarge (ie, home) settings are summarized. A comprehensive search of peer-reviewed randomized controlled trials involving early interventions for infants and their mother published between 1993 and 2013 in the electronic databases PubMed, CINAHL, EMBASE, PsychINFO, and Cochrane was undertaken. Methodological quality was assessed using the PEDro scale to evaluate internal and external validity of the study. Twelve randomized controlled trials were included in the review, and all used some form of parenting education. The interventions had limited effects on maternal stress and mother-infant interaction and positive effects on maternal anxiety, depressive symptoms, and maternal coping. There were positive effects on infants' short-term outcomes for length of stay and breast-feeding rate. Positive and clinically meaningful effects of early interventions were seen in some physiological/psychological outcomes of mothers and preterm infants. It is important for nurses to foster close mother-infant contact and increase maternal competence during and after the infant's hospitalization period.

Conflict adaptation in positive and negative mood: Applying a success-failure manipulation.

PubMed

Schuch, Stefanie; Zweerings, Jana; Hirsch, Patricia; Koch, Iring

2017-05-01

Conflict adaptation is a cognitive mechanism denoting increased cognitive control upon detection of conflict. This mechanism can be measured by the congruency sequence effect, indicating the reduction of congruency effects after incongruent trials (where response conflict occurs) relative to congruent trials (without response conflict). Several studies have reported increased conflict adaptation under negative, as compared to positive, mood. In these studies, sustained mood states were induced by film clips or music combined with imagination techniques; these kinds of mood manipulations are highly obvious, possibly distorting the actual mood states experienced by the participants. Here, we report two experiments where mood states were induced in a less obvious way, and with higher ecological validity. Participants received success or failure feedback on their performance in a bogus intelligence test, and this mood manipulation proved highly effective. We largely replicated previous findings of larger conflict adaptation under negative mood than under positive mood, both with a Flanker interference paradigm (Experiment 1) and a Stroop-like interference paradigm (Experiment 2). Results are discussed with respect to current theories on affective influences on cognitive control. Copyright © 2017 Elsevier B.V. All rights reserved.

A randomized crossover trial to study the effect of personalized, one-to-one interaction using Montessori-based activities on agitation, affect, and engagement in nursing home residents with Dementia.

PubMed

van der Ploeg, Eva S; Eppingstall, Barbara; Camp, Cameron J; Runci, Susannah J; Taffe, John; O'Connor, Daniel W

2013-04-01

Increasingly more attention has been paid to non-pharmacological interventions as treatment of agitated behaviors that accompany dementia. The aim of the current study is to test if personalized one-to-one interaction activities based on Montessori principles will improve agitation, affect, and engagement more than a relevant control condition. We conducted a randomized crossover trial in nine residential facilities in metropolitan Melbourne, Australia (n = 44). Personalized one-to-one activities that were delivered using Montessori principles were compared with a non-personalized activity to control for the non-specific benefits of one-to-one interaction. Participants were observed 30 minutes before, during, and after the sessions. The presence or absence of a selected physically non-aggressive behavior was noted in every minute, together with the predominant type of affect and engagement. Behavior counts fell considerably during both the Montessori and control sessions relative to beforehand. During Montessori activities, the amount of time spend actively engaged was double compared to during the control condition and participants displayed more positive affect and interest as well. Participants with no fluency in English (all from non-English speaking backgrounds) showed a significantly larger reduction in agitation during the Montessori than control sessions. Our results show that even non-personalized social contact can assist in settling agitated residents. Tailoring activities to residents' needs and capabilities elicit more positive interactions and are especially suitable for people who have lost fluency in the language spoken predominantly in their residential facility. Future studies could explore implementation by family members and volunteers to avoid demands on facilities' resources. Australian New Zealand Clinical Trials Registry - ACTRN12609000564257.

Effects of continuous positive airway pressure on neurocognitive architecture and function in patients with obstructive sleep apnoea: study protocol for a multicentre randomised controlled trial

PubMed Central

Xu, Huajun; Wang, Hui; Guan, Jian; Yi, Hongliang; Qian, Yingjun; Zou, Jianyin; Xia, Yunyan; Fu, Yiqun; Li, Xinyi; Jiao, Xiao; Huang, Hengye; Dong, Pin; Yu, Ziwei; Yang, Jun; Xiang, Mingliang; Li, Jiping; Chen, Yanqing; Wang, Peihua; Sun, Yizhou; Li, Yuehua; Zheng, Xiaojian; Jia, Wei; Yin, Shankai

2017-01-01

Objectives Many clinical studies have indicated that obstructive sleep apnoea (OSA), the most common chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous positive airway pressure (CPAP) has some neurocognitive protective effects against the adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture and function remain unclear. Therefore, this multicentre trial was designed to investigate whether and when neurocognitive architecture and function in patients with OSA can be improved by CPAP treatment and to explore the role of gut microbiota in improving neurocognitive function during treatment. Methods/design This study will be a multicentre, randomised, controlled trial with allocation concealment and assessor blinding. A total of 148 eligible patients with moderate to severe OSA will be enrolled from five sleep centres and randomised to receive CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive function, structure and function of brain regions, gut microbiota, metabolites, biochemical variables, electrocardiography, echocardiography, pulmonary function and arterial stiffness will be assessed at baseline before randomisation and at 3, 6 and 12 months. Ethics and dissemination This study has been approved by the Medical Ethics Committee of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital (approval number 2015-79). The results from this study will be published in peer-reviewed journals and at relevant conferences. Trial registration number NCT02886156; pre-results. PMID:28550021

Trimethoprim as Adjuvant Treatment in Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

PubMed Central

Shibre, Teshome; Alem, Atalay; Abdulahi, Abdulreshid; Araya, Mesfin; Beyero, Teferra; Medhin, Girmay; Deyassa, Negusse; Negash, Alemayehu; Nigatu, Alemayehu; Kebede, Derege

2010-01-01

Various infectious agents, such as Toxoplasma gondii, have been hypothesized to be potentially relevant etiological factors in the onset of some cases of schizophrenia. We conducted a randomized, double-blind, placebo-controlled treatment trial in an attempt to explore the hypothesis that the symptoms of schizophrenia may be related to infection of the central nervous system with toxoplasma gondii. Systematically selected patients with ongoing and at least moderately severe schizophrenia from Butajira, in rural Ethiopia, were randomly allocated to trimethoprim or placebo, which were added on to participants' regular antipsychotic treatments. Trial treatments were given for 6 months. The Positive and Negative Syndrome Scale (PANSS) was used to assess outcome. Ninety-one patients were included in the study, with 80 cases (87.9%) positive for T. gondii immunoglobulin G antibody. Seventy-nine subjects (87.0%) completed the trial. The mean age of subjects was 35.3 (SD = 8.0) years, with a mean duration of illness of 13.2 (SD = 6.7) years. Both treatment groups showed significant reduction in the overall PANSS score with no significant between-group difference. In this sample of patients with chronic schizophrenia, trimethoprim used as adjuvant treatment is not superior to placebo. However, it is not possible to draw firm conclusion regarding the etiological role of toxoplasmosis on schizophrenia based on this study because the timing and the postulated mechanisms through which toxoplasmosis produces schizophrenia are variable. PMID:19193743

Effectiveness of Vitamin D Supplement Therapy in Chronic Stable Schizophrenic Male Patients: A Randomized Controlled Trial.

PubMed

Sheikhmoonesi, Fatemeh; Zarghami, Mehran; Mamashli, Shima; Yazdani Charati, Jamshid; Hamzehpour, Romina; Fattahi, Samineh; Azadbakht, Rahil; Kashi, Zahra; Ala, Shahram; Moshayedi, Mona; Alinia, Habibollah; Hendouei, Narjes

2016-01-01

In this study, the aim was to determine whether adding vitamin D to the standard therapeutic regimen of schizophrenic male patients with inadequate vitamin D status could improve some aspects of the symptom burden or not. This study was an open parallel label randomized clinical trial. Eighty patients with chronic stable schizophrenia with residual symptoms and Vitamin D deficiency were recruited randomly and then received either 600000 IU Vitamin D injection once along with their antipsychotic regimen or with their antipsychotic regimen only. Serum vitamin D was measured twice: first at the baseline and again on the fourth month. Positive and Negative Syndrome Scale (PANSS) was assessed at the baseline and on the fourth month. During the study, the vitamin D serum changes in vitamin group and control group were 22.1 ± 19.9(95%CI = 15.9-28.8) and 0.2 ± 1.7(95%CI = 0.2-0.8) (ng/mL) (p<0.001) respectively. The changes of PANSS positive subscale score (P) were -0.1±0.7 (95%CI =-0.3-0.1) and 0.00 ± 0.8 (95%CI = -0.2-0.2) in vitamin D and control group respectively (p=0.5). The changes of PANSS negative subscale score (N) were -0.1 ± 0.7 (95%CI = -0.3-0.05) and -0.1 ± 0.5 (95%CI = -0.2-0.04) in vitamin D and control group respectively (p = 0.7) and there was a negative but not significant correlation between serum vitamin D level changes and PANSS negative subscale score (r = -0.04, p = 0.7). We did not find a relationship between serum vitamin D level changes and the improvement of negative and positive symptoms in schizophrenic patients and more randomized clinical trials are required to confirm our findings.

The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial

PubMed Central

Huang, Shu-Ling; Li, Ren-Hau; Huang, Feng-Ying; Tang, Feng-Cheng

2015-01-01

Objectives This study aims to intensively evaluate the effectiveness of mindfulness-based intervention (MBI) on mental illness risks (including psychological distress, prolonged fatigue, and perceived stress) and job strain (job control and job demands) for employees with poor mental health. Methods A longitudinal research design was adopted. In total, 144 participants were randomized to the intervention group or the control group. The intervention group participated in MBI for eight weeks. Measurements were collected for both groups at five time points: at pre-intervention (T1), at mid-intervention (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight weeks after intervention (T5). Data were analyzed according to the intention-to-treat principle. A linear mixed model with two levels was employed to analyze the repeated measurement data. Results Compared with the control group, the intercepts (means at T3) for the intervention group were significantly lower on psychological distress, prolonged fatigue, and perceived stress when MBI was completed. Even with the demographic variables controlled, the positive effects remained. For growth rates of prolonged fatigue and perceived stress, participants in the intervention group showed a steeper decrease than did the participants in the control group. Regarding job strain, although the intercept (mean at T3) of job demands showed a significant decline when BMI was completed, the significance disappeared when the demographic variables were controlled. Moreover, the other results for job control and job demands did not show promising findings. Conclusion As a workplace health promotion program, the MBI seems to have potential in improving mental illness risks for employees with poor mental health. However, there was insufficient evidence to support its effect on mitigating job strain. Further research on maintaining the positive effects on mental health for the long term and on developing innovative MBI to suit job strain are recommended. Trial Registration ClinicalTrials.gov NCT02241070 PMID:26367270

Effectiveness of teaching cognitive-behavioral techniques on locus of control in hemodialysis patients.

PubMed

Mehrtak, Mohammad; Habibzadeh, Shahram; Farzaneh, Esmaeil; Rjaei-Khiavi, Abdollah

2017-10-01

Many of the cognitive behavioral models and therapeutic protocols developed so far for psychological disorders and chronic diseases have proved effective through clinical research. This study aimed to determine the effectiveness of teaching cognitive-behavioral techniques on locus of control in hemodialysis patients. This controlled clinical trial study was conducted in 2015 with 76 patients selected by census and treated with a hemodialysis machine in the dialysis department of Vali-Asr Hospital in the city of Meshkinshahr. A total of four patients were excluded because of their critical conditions while the rest, who were recruited, were randomly divided into two equal groups of 36 patients as the intervention and control groups. First, the locus of control was measured in both groups through a pretest, and cognitive-behavioral techniques were then taught to the intervention group during eight 45 to 90-minute sessions. The locus of control in patients of both groups was finally re-measured through a posttest. Data were collected using Rotter's Locus of Control Inventory. The Wilcoxon test and Mann-Whitney U test were respectively used in SPSS18 for data analysis. In the pretest and posttest stages respectively, 4.8% and 14.3% of samples in the control group as well as 14.3% and 33.3% of samples in the intervention group enjoyed internal locus of control. The difference between the pretest and posttest scores of internal locus of control in the intervention group was significant (p=0.004), which indicates the positive effect of cognitive-behavioral psychotherapeutic intervention on internalization of locus of control in this group. Given the external locus of control in most of the study patients and also the positive significant effect of cognitive-behavioral psychotherapy on internalization of locus of control in this group of patients, it appears necessary to have a psychology resident present in the hemodialysis department to teach the necessary cognitive-behavioral techniques to internalize the locus of control. The trial was registered at the Thai Clinical Trial Registry (http://www.clinicaltrials.in.th) with the TCTID: TCTR20170707003. The authors received no financial support for the research, authorship, and/or publication of this article.

External cephalic version facilitation for breech presentation at term.

PubMed

Hofmeyr, G J

2000-01-01

Successful external cephalic version at a late stage of pregnancy was considered to be possible only with the use of tocolytic drugs to relax the uterus. Other methods are also used in an attempt to facilitate external cephalic version at term. The objective of this review was to assess the effects of routine tocolysis, fetal acoustic stimulation, epidural anaesthesia and transabdominal amnioinfusion for external cephalic version at term on successful version and measures of pregnancy outcome. The Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register were searched. Date of last search: February 1999. Randomised and quasi-randomised trials comparing routine versus selective tocolysis; fetal acoustic stimulation in midline fetal spine positions versus dummy or no stimulation; epidural analgesia versus no epidural analgesia; or transabdominal amnioinfusion versus no amnioinfusion for external cephalic version at term. Eligibility and trial quality were assessed by the reviewer. Six trials were included. Routine tocolysis was associated with fewer failures of external cephalic version (relative risk 0.77, 95% confidence interval 0.64 to 0.92). There were no significant differences between non-cephalic presentations and caesarean sections. Fetal acoustic stimulation in midline fetal spine positions was associated with fewer failures of external cephalic version at term (relative risk 0.17, 95% confidence interval 0.05 to 0.60). No randomised trials of epidural analgesia or transabdominal amnioinfusion for external cephalic version at term were located. Routine tocolysis appears to reduce the failure rate of external cephalic version at term. Although promising, there is not enough evidence to evaluate the use of fetal acoustic stimulation in midline fetal spine positions. There is not enough evidence to evaluate the use of epidural analgesia or transabdominal amnioinfusion for external cephalic version at term.

Effects of Interventions on Survival in Acute Respiratory Distress Syndrome: an Umbrella Review of 159 Published Randomized Trials and 29 Meta-analyses

PubMed Central

Tonelli, Adriano R.; Zein, Joe; Adams, Jacob; Ioannidis, John P.A.

2014-01-01

Purpose Multiple interventions have been tested in acute respiratory distress syndrome (ARDS). We examined the entire agenda of published randomized controlled trials (RCTs) in ARDS that reported on mortality and of respective meta-analyses. Methods We searched PubMed, the Cochrane Library and Web of Knowledge until July 2013. We included RCTs in ARDS published in English. We excluded trials of newborns and children; and those on short-term interventions, ARDS prevention or post-traumatic lung injury. We also reviewed all meta-analyses of RCTs in this field that addressed mortality. Treatment modalities were grouped in five categories: mechanical ventilation strategies and respiratory care, enteral or parenteral therapies, inhaled / intratracheal medications, nutritional support and hemodynamic monitoring. Results We identified 159 published RCTs of which 93 had overall mortality reported (n= 20,671 patients) - 44 trials (14,426 patients) reported mortality as a primary outcome. A statistically significant survival benefit was observed in 8 trials (7 interventions) and two trials reported an adverse effect on survival. Among RTCs with >50 deaths in at least 1 treatment arm (n=21), 2 showed a statistically significant mortality benefit of the intervention (lower tidal volumes and prone positioning), 1 showed a statistically significant mortality benefit only in adjusted analyses (cisatracurium) and 1 (high-frequency oscillatory ventilation) showed a significant detrimental effect. Across 29 meta-analyses, the most consistent evidence was seen for low tidal volumes and prone positioning in severe ARDS. Conclusions There is limited supportive evidence that specific interventions can decrease mortality in ARDS. While low tidal volumes and prone positioning in severe ARDS seem effective, most sporadic findings of interventions suggesting reduced mortality are not corroborated consistently in large-scale evidence including meta-analyses. PMID:24667919

Company stock prices before and after public announcements related to oncology drugs.

PubMed

Rothenstein, Jeffrey M; Tomlinson, George; Tannock, Ian F; Detsky, Allan S

2011-10-19

Phase III clinical trials and Food and Drug Administration (FDA) regulatory decisions are critical for success of new drugs and can influence a company's market valuation. Knowledge of trial results before they are made public (ie, "inside information") can affect the price of a drug company's stock. We examined the stock prices of companies before and after public announcements regarding experimental anticancer drugs owned by the companies. We identified drugs that were undergoing evaluation in phase III trials or for regulatory approval by the US FDA from January 2000 to January 2009. Stock prices of companies that owned such drugs were analyzed for 120 trading days before and after the first public announcement of 1) results of clinical trials with positive and negative outcomes and 2) positive and negative regulatory decisions. All statistical tests were two-sided. We identified public announcements from 23 positive trials and 36 negative trials and from 41 positive and nine negative FDA regulatory decisions. The mean stock price for the 120 trading days before a phase III clinical trial announcement increased by 13.7% (95% confidence interval = -2.2% to 29.6%) for companies that reported positive trials and decreased by 0.7% (95% confidence interval = -13.8% to 12.3%) for companies that reported negative trials (P = .09). In a post hoc analysis comparing the stock price averaged over 60 trading days before and after day -60 relative to the clinical trial announcement, the mean stock price increased by 9.4% for companies that reported positive trials and decreased by 4.5% for companies that reported negative trials (P = .03). Changes in company stock prices before FDA regulatory decisions did not differ statistically between companies with positive decision and companies with negative decisions. Trends in company stock prices before the first public announcement differ for companies that report positive vs negative trials. This finding has important legal and ethical implications for investigators, drug companies, and the investment industry.

Effect of prone positioning during mechanical ventilation on mortality among patients with acute respiratory distress syndrome: a systematic review and meta-analysis.

PubMed

Sud, Sachin; Friedrich, Jan O; Adhikari, Neill K J; Taccone, Paolo; Mancebo, Jordi; Polli, Federico; Latini, Roberto; Pesenti, Antonio; Curley, Martha A Q; Fernandez, Rafael; Chan, Ming-Cheng; Beuret, Pascal; Voggenreiter, Gregor; Sud, Maneesh; Tognoni, Gianni; Gattinoni, Luciano; Guérin, Claude

2014-07-08

Mechanical ventilation in the prone position is used to improve oxygenation and to mitigate the harmful effects of mechanical ventilation in patients with acute respiratory distress syndrome (ARDS). We sought to determine the effect of prone positioning on mortality among patients with ARDS receiving protective lung ventilation. We searched electronic databases and conference proceedings to identify relevant randomized controlled trials (RCTs) published through August 2013. We included RCTs that compared prone and supine positioning during mechanical ventilation in patients with ARDS. We assessed risk of bias and obtained data on all-cause mortality (determined at hospital discharge or, if unavailable, after longest follow-up period). We used random-effects models for the pooled analyses. We identified 11 RCTs (n=2341) that met our inclusion criteria. In the 6 trials (n=1016) that used a protective ventilation strategy with reduced tidal volumes, prone positioning significantly reduced mortality (risk ratio 0.74, 95% confidence interval 0.59-0.95; I2=29%) compared with supine positioning. The mortality benefit remained in several sensitivity analyses. The overall quality of evidence was high. The risk of bias was low in all of the trials except one, which was small. Statistical heterogeneity was low (I2<50%) for most of the clinical and physiologic outcomes. Our analysis of high-quality evidence showed that use of the prone position during mechanical ventilation improved survival among patients with ARDS who received protective lung ventilation. © 2014 Canadian Medical Association or its licensors.

The Effect of Head Positioning and Head Tilting on the Incidence of Intraventricular Hemorrhage in Very Preterm Infants: A Systematic Review.

PubMed

de Bijl-Marcus, Karen A; Brouwer, Annemieke J; de Vries, Linda S; van Wezel-Meijler, Gerda

2017-01-01

Despite advances in neonatal intensive care, germinal matrix-intraventricular hemorrhage (GMH-IVH) remains a frequent, serious complication of premature birth. Neutral head position and head tilting have been suggested to reduce the risk of GMH-IVH in preterm infants during the first 72 h of life. The aim of this study was to provide a systematic review of the effect of neutral head positioning and head tilting on the incidence of GMH-IVH in very preterm infants (gestational age ≤30 weeks). In addition, we reviewed their effect on cerebral hemodynamics and oxygenation. Literature was searched (June 2016) in the following electronic databases: CINAHL, Embase, Medline, SCOPUS, and several trial registers. One underpowered trial studied the effect of head positioning on the incidence of GMH-IVH. This randomized controlled trial enrolled 48 preterm infants and found no effect on the occurrence of GMH-IVH. Three observational studies investigated the effect of head rotation and/or tilting on cerebral oxygenation in 68 preterm infants in total. Their results suggest that cerebral oxygenation is not significantly affected by changes in head positioning. The effect of head positioning and/or tilting on cerebral hemodynamics was described in 2 observational studies of 28 preterm infants and found no significant effect. There is insufficient evidence regarding the effect of head positioning and tilting on the incidence of GMH-IVH and cerebral hemodynamics and oxygenation in preterm infants. We recommend further research in this field, especially in extremely preterm and clinically unstable infants during the first postnatal days. © 2016 S. Karger AG, Basel.

Effect of prone positioning during mechanical ventilation on mortality among patients with acute respiratory distress syndrome: a systematic review and meta-analysis

PubMed Central

Sud, Sachin; Friedrich, Jan O.; Adhikari, Neill K. J.; Taccone, Paolo; Mancebo, Jordi; Polli, Federico; Latini, Roberto; Pesenti, Antonio; Curley, Martha A.Q.; Fernandez, Rafael; Chan, Ming-Cheng; Beuret, Pascal; Voggenreiter, Gregor; Sud, Maneesh; Tognoni, Gianni; Gattinoni, Luciano; Guérin, Claude

2014-01-01

Background: Mechanical ventilation in the prone position is used to improve oxygenation and to mitigate the harmful effects of mechanical ventilation in patients with acute respiratory distress syndrome (ARDS). We sought to determine the effect of prone positioning on mortality among patients with ARDS receiving protective lung ventilation. Methods: We searched electronic databases and conference proceedings to identify relevant randomized controlled trials (RCTs) published through August 2013. We included RCTs that compared prone and supine positioning during mechanical ventilation in patients with ARDS. We assessed risk of bias and obtained data on all-cause mortality (determined at hospital discharge or, if unavailable, after longest follow-up period). We used random-effects models for the pooled analyses. Results: We identified 11 RCTs (n = 2341) that met our inclusion criteria. In the 6 trials (n = 1016) that used a protective ventilation strategy with reduced tidal volumes, prone positioning significantly reduced mortality (risk ratio 0.74, 95% confidence interval 0.59–0.95; I2 = 29%) compared with supine positioning. The mortality benefit remained in several sensitivity analyses. The overall quality of evidence was high. The risk of bias was low in all of the trials except one, which was small. Statistical heterogeneity was low (I2 < 50%) for most of the clinical and physiologic outcomes. Interpretation: Our analysis of high-quality evidence showed that use of the prone position during mechanical ventilation improved survival among patients with ARDS who received protective lung ventilation. PMID:24863923

Warm-up for Sprint Swimming: Race-Pace or Aerobic Stimulation? A Randomized Study.

PubMed

Neiva, Henrique P; Marques, Mário C; Barbosa, Tiago M; Izquierdo, Mikel; Viana, João L; Teixeira, Ana M; Marinho, Daniel A

2017-09-01

Neiva, HP, Marques, MC, Barbosa, TM, Izquierdo, M, Viana, JL, Teixeira, AM, and Marinho, DA. Warm-up for sprint swimming: race-pace or aerobic stimulation? A randomized study. J Strength Cond Res 31(9): 2423-2431, 2017-The aim of this study was to compare the effects of 2 different warm-up intensities on 100-m swimming performance in a randomized controlled trial. Thirteen competitive swimmers performed two 100-m freestyle time-trials on separate days after either control or experimental warm-up in a randomized design. The control warm-up included a typical race-pace set (4 × 25 m), whereas the experimental warm-up included an aerobic set (8 × 50 m at 98-102% of critical velocity). Cortisol, testosterone, blood lactate ([La]), oxygen uptake (V[Combining Dot Above]O2), heart rate, core (Tcore and Tcorenet) and tympanic temperatures, and rating of perceived exertion (RPE) were monitored. Stroke length (SL), stroke frequency (SF), stroke index (SI), and propelling efficiency (ηp) were assessed for each 50-m lap. We found that V[Combining Dot Above]O2, heart rate, and Tcorenet were higher after experimental warm-up (d > 0.73), but only the positive effect for Tcorenet was maintained until the trial. Performance was not different between conditions (d = 0.07). Experimental warm-up was found to slow SF (mean change ±90% CL = 2.06 ± 1.48%) and increase SL (1.65 ± 1.40%) and ηp (1.87 ± 1.33%) in the first lap. After the time-trials, this warm-up had a positive effect on Tcorenet (d = 0.69) and a negative effect on [La] (d = 0.56). Although the warm-ups had similar outcomes in the 100-m freestyle, performance was achieved through different biomechanical strategies. Stroke length and efficiency were higher in the first lap after the experimental warm-up, whereas SF was higher after control warm-up. Physiological adaptations were observed mainly through an increased Tcore after experimental warm-up. In this condition, the lower [La] after the trial suggests lower dependency on anaerobic metabolism.

Intervention Effects on Adolescent Physical Activity in the Multicomponent SPACE Study: A Cluster Randomized Controlled Trial

PubMed Central

Toftager, Mette; Christiansen, Lars B.; Ersbøll, Annette K.; Kristensen, Peter L.; Due, Pernille; Troelsen, Jens

2014-01-01

Background Multicomponent school-based interventions have the potential to reduce the age-related decline in adolescents' physical activity (PA), yet there is not consistent evidence to guide non-curricular and school environment interventions. The aim of this study was to assess the effectiveness of a multicomponent environmental school-based intervention, designed to reduce the age-related decline in PA among adolescents. Methods A cluster randomized controlled trial was conducted with 7 intervention and 7 control schools. Baseline measurements were carried out in spring 2010 with 2 years of follow-up. A total of 1,348 students (11–13 years, in grade 5 and 6) enrolled in the study at baseline. The 14 schools included in the study were located in the Region of Southern Denmark. The intervention consisted of organizational and physical changes in the school environment with a total of 11 intervention components. The primary outcome measure was overall PA (cpm, counts per minute) and was supported by analyses of time spent in MVPA, and time spent sedentary. Furthermore, a secondary outcome measure was PA in school time and during recess. PA was measured using accelerometer (Actigraph GT3X). Results A total of 797 students completed the trial and had valid accelerometer data. No significant difference was found for overall PA with an adjusted difference of −19.1 cpm (95% CI: −93, 53) or for school time activity with an adjusted difference of 6 cpm (95% CI: −73, 85). A sensitivity analysis revealed a positive significant intervention effect of PA in recess with an adjusted difference of 95 cpm. Conclusions No evidence was found of the overall effect of a non-curricular multicomponent school-based intervention on PA among Danish adolescents. The intervention was positively associated with PA during school time and recess, however, with small estimates. Lack of effect on overall PA could be due to both program theory and different degrees of implementation. Trial Registration www.Controlled-Trials.com ISRCTN79122411 PMID:24921948

Evaluation of Post-Trial Reviews of Courts-Martial within the Department of the Navy

DTIC Science & Technology

2010-12-10

subject to a penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE...Moreno case in an effort to take control of a situation the Navy and Marine Corps would not address. Over the years, the appellate courts repeatedly...inexperienced, first-tour lieutenants. Consequently, having senior, experienced counsel in supervisory positions is essential to controlling quality

Motivational interviewing in a Web-based physical activity intervention with an avatar: randomized controlled trial.

PubMed

Friederichs, Stijn; Bolman, Catherine; Oenema, Anke; Guyaux, Janneke; Lechner, Lilian

2014-02-13

Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based. The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based. A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention. Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (beta(AVATARvsCONTROL)=.39, P=.011; beta(TEXTvsCONTROL)=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone. The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user's state and input. Dutch Trial Register trial number: NTR3147; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3147 (Archived by WebCite at http://www.webcitation.org/6NCbwdUJX).

The Positive Outlook Study: A Randomised Controlled Trial Evaluating Online Self-Management for HIV Positive Gay Men.

PubMed

Millard, Tanya; Agius, Paul A; McDonald, Karalyn; Slavin, Sean; Girdler, Sonya; Elliott, Julian H

2016-09-01

The aim of this paper was to evaluate the effectiveness of an online self-management program in improving health outcomes and well-being for gay men living with HIV in Australia. The online Positive Outlook Program was based on self-efficacy theory and used a self-management approach to enhance HIV-positive gay men's skills, confidence and abilities to manage the psychosocial issues associated with HIV in daily life. The 7-week program was delivered in closed groups and comprised information modules, action-planning activities, moderated discussion boards, and weekly peer-facilitated 'live chats'. A randomised controlled trial was conducted to establish the effectiveness of the Positive Outlook program compared to a 'usual care' control. Participants were HIV-positive gay men 18 years or older living in Australia. Primary outcomes were evaluated at three time-points (baseline, post-intervention and 12-week's post-intervention follow-up) and included HIV-related quality of life (PROQOL-HIV), outcomes of health education (HeiQ) and HIV specific self-efficacy (Positive Outlook Self-Efficacy Scale). A total of 132 gay men with HIV in Australia were randomly allocated to the intervention (n = 68) or usual care control (n = 64) groups. Maximum likelihood marginal-linear modelling indicated significant improvement in the intervention group on the PROQOL-HIV subscales of body change (p = 0.036), social relationships (p = 0.035) and emotional distress (p = 0.031); the HeiQ subscales of health-directed activity (p = 0.048); constructive attitudes and approaches (p = 0.015); skill and technique acquisition (p = 0.046) and health service navigation (p = 0.008); and the Positive Outlook Self-Efficacy Scale on the subscales of relationships (p = 0.019); social participation (p = 0.006); and emotions (p = 0.041). Online delivery of self-management programs is feasible and has the potential to improve quality of life, self-management skills and domain specific self-efficacy for gay men with HIV.

WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial

PubMed Central

2014-01-01

Background The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. Methods/Design This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18–65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. Discussion This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes and inform the evaluation strategy, including sample size calculation, for a future definitive RCT. Trial registration Current Controlled Trials ISRCTN04199273 – WELLFOCUS study: an intervention to improve well-being in people with psychosis, Date registered: 27 March 2013, first participant randomised on 26 April 2013. PMID:24888479

LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ≥34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists. Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation. Methods/design This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ≥34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA SupremeTM, LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life. Trial registration ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013). PMID:25027230

Ad-hoc and context-dependent adjustments of selective attention in conflict control: an ERP study with visual probes.

PubMed

Nigbur, R; Schneider, J; Sommer, W; Dimigen, O; Stürmer, B

2015-02-15

Cognitive conflict control in flanker tasks has often been described using the zoom-lens metaphor of selective attention. However, whether and how selective attention - in terms of suppression and enhancement - operates in this context has remained unclear. To examine the dynamic interplay of selective attention and cognitive control we used electrophysiological measures and presented task-irrelevant visual probe stimuli at foveal, parafoveal, and peripheral display positions. Target-flanker congruency varied either randomly from trial to trial (mixed-block) or block-wise (fixed-block) in order to induce reactive versus proactive control modes, respectively. Three EEG measures were used to capture ad-hoc adjustments within trials as well as effects of context-based predictions: the N1 component of the visual evoked potential (VEP) to probes, the VEP to targets, and the conflict-related midfrontal N2 component. Results from probe-VEPs indicate that enhanced processing of the foveal target rather than suppression of the peripheral flankers supports interference control. In incongruent mixed-block trials VEPs were larger to probes near the targets. In the fixed-blocks probe-VEPs were not modulated, but contrary to the mixed-block the preceding target-related VEP was affected by congruency. Results of the control-related N2 reveal largest amplitudes in the unpredictable context, which did not differentiate for stimulus and response incongruency. In contrast, in the predictable context, N2 amplitudes were reduced overall and differentiated between stimulus and response incongruency. Taken together these results imply that predictability alters interference control by a reconfiguration of stimulus processing. During unpredictable sequences participants adjust their attentional focus dynamically on a trial-by-trial basis as reflected in congruency-dependent probe-VEP-modulation. This reactive control mode also elicits larger N2 amplitudes. In contrast, when task demands are predictable, participants focus selective attention earlier as reflected in the target-related VEPs. This proactive control mode leads to smaller N2 amplitudes and absent probe effects. Copyright © 2014 Elsevier Inc. All rights reserved.

Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

ERIC Educational Resources Information Center

Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

2004-01-01

The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

Comparison of the effects of continuous positive airway pressure and mandibular advancement devices on sleepiness in patients with obstructive sleep apnoea: a network meta-analysis.

PubMed

Bratton, Daniel J; Gaisl, Thomas; Schlatzer, Christian; Kohler, Malcolm

2015-11-01

Excessive daytime sleepiness is the most important symptom of obstructive sleep apnoea and can affect work productivity, quality of life, and the risk of road traffic accidents. We aimed to quantify the effects of the two main treatments for obstructive sleep apnoea (continuous positive airway pressure and mandibular advancement devices) on daytime sleepiness and to establish predictors of response to continuous positive airway pressure. We searched MEDLINE and the Cochrane Library from inception to May 31, 2015, to identify randomised controlled trials comparing the effects of continuous positive airway pressure, mandibular advancement devices or an inactive control (eg, placebo or no treatment) on the Epworth Sleepiness Scale (ESS, range 0-24 points) in patients with obstructive sleep apnoea. We did a network meta-analysis using multivariate random-effects meta-regression to assess the effect of each treatment on ESS. We used meta-regression to assess the association of the reported effects of continuous positive airway pressure versus inactive controls with the characteristics of trials and their risk of bias. We included 67 studies comprising 6873 patients in the meta-analysis. Compared with an inactive control, continuous positive airway pressure was associated with a reduction in ESS score of 2·5 points (95% CI 2·0-2·9) and mandibular advancement devices of 1·7 points (1·1-2·3). We estimated that, on average, continuous positive airway pressure reduced the ESS score by a further 0·8 points compared with mandibular advancement devices (95% CI 0·1-1·4; p=0·015). However, there was a possibility of publication bias in favour of continuous positive airway pressure that might have resulted in this difference. We noted no evidence that studies reporting higher continuous positive airway pressure adherence also reported larger treatment effects (p=0·70). Continuous positive airway pressure and mandibular advancement devices are effective treatments for reducing daytime sleepiness in patients with obstructive sleep apnoea. Continuous positive airway pressure seemed to be a more effective treatment than mandibular advancement devices, and had an increasingly larger effect in more severe or sleepier obstructive sleep apnoea patients when compared with inactive controls. However, mandibular advancement devices are an effective alternative treatment should continuous positive airway pressure not be tolerated. Swiss National Science Foundation and the University of Zurich Clinical Research Priority Program Sleep and Health. Copyright © 2015 Elsevier Ltd. All rights reserved.

Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial.

PubMed

Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

2010-01-01

This paper reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools (mean enrollment = 544) and was conducted from the 2002-03 through the 2005-06 academic years. Using school-level archival data, analyses comparing change from baseline (2002) to one-year post trial (2007) revealed that intervention schools scored 9.8% better on the TerraNova (2 nd ed.) test for reading and 8.8% on math; 20.7% better in Hawai'i Content and Performance Standards scores for reading and 51.4% better in math; and that intervention schools reported 15.2% lower absenteeism and fewer suspensions (72.6%) and retentions (72.7%). Overall, effect sizes were moderate to large (range 0.5-1.1) for all of the examined outcomes. Sensitivity analyses using permutation models and random-intercept growth curve models substantiated results. The results provide evidence that a comprehensive school-based program, specifically developed to target student behavior and character, can positively influence school-level achievement, attendance, and disciplinary outcomes concurrently.

Polysaccharide K and Coriolus versicolor extracts for lung cancer: a systematic review.

PubMed

Fritz, Heidi; Kennedy, Deborah A; Ishii, Mami; Fergusson, Dean; Fernandes, Rochelle; Cooley, Kieran; Seely, Dugald

2015-05-01

Polysaccharide K, also known as PSK or Krestin, is derived from the Coriolus versicolor mushroom and is widely used in Japan as an adjuvant immunotherapy for a variety of cancer including lung cancer. Despite reported benefits, there has been no English language synthesis of PSK for lung cancer. To address this knowledge gap, we conducted a systematic review of PSK for the treatment of lung cancer. We searched PubMed, EMBASE, CINAHL, the Cochrane Library, AltHealth Watch, and the Library of Science and Technology from inception to August 2014 for clinical and preclinical evidence pertaining to the safety and efficacy of PSK or other Coriolus versicolor extracts for lung cancer. Thirty-one reports of 28 studies were included for full review and analysis. Six studies were randomized controlled trials, 5 were nonrandomized controlled trials, and 17 were preclinical studies. Nine of the reports were Japanese language publications. Fifteen of 17 preclinical studies supported anticancer effects for PSK through immunomodulation and potentiation of immune surveillance, as well as through direct tumor inhibiting actions in vivo that resulted in reduced tumor growth and antimetastatic effects. Nonrandomized controlled trials showed improvement of various survival measures including median survival and 1-, 2-, and 5-year survival. Randomized controlled trials showed benefits on a range of endpoints, including immune parameters and hematological function, performance status and body weight, tumor-related symptoms such as fatigue and anorexia, as well as survival. Although there were conflicting results for impact on some of the tumor-related symptoms and median survival, overall most randomized controlled trials supported a positive impact for PSK on these endpoints. PSK was safely administered following and in conjunction with standard radiation and chemotherapy. PSK may improve immune function, reduce tumor-associated symptoms, and extend survival in lung cancer patients. Larger, more rigorous randomized controlled trials for PSK in lung cancer patients are warranted. © The Author(s) 2015.

The Steroids for Corneal Ulcers Trial

PubMed Central

Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V.; Ray, Kathryn J.; Hong, Kevin C.; Oldenburg, Catherine E.; Lee, Salena M.; Zegans, Michael E.; McLeod, Stephen D.; Lietman, Thomas M.; Acharya, Nisha R.

2013-01-01

Objectives To provide comprehensive trial methods and baseline data for the Steroids for Corneal Ulcers Trial and to present epidemiological characteristics such as risk factors, causative organisms, and ulcer severity. Methods Baseline data from a 1:1 randomized, placebo-controlled, double-masked clinical trial comparing prednisolone phosphate, 1%, with placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and had been taking moxifloxacin for 48 hours. The primary outcome for the trial is best spectacle-corrected visual acuity at 3 months from enrollment. This report provides comprehensive baseline data, including best spectacle-corrected visual acuity, infiltrate size, microbio-logical results, and patient demographics, for patients enrolled in the trial. Results Of 500 patients enrolled, 97% were in India. Two hundred twenty patients (44%) were agricultural workers. Median baseline visual acuity was 0.84 logMAR (Snellen, 20/125) (interquartile range, 0.36-1.7; Snellen, 20/50 to counting fingers). Baseline visual acuity was not significantly different between the United States and India. Ulcers in India had larger infiltrate/scar sizes (P=.04) and deeper infiltrates (P=.04) and were more likely to be localized centrally (P=.002) than ulcers enrolled in the United States. Gram-positive bacteria were the most common organisms isolated from the ulcers (n=366, 72%). Conclusions The Steroids for Corneal Ulcers Trial will compare the use of a topical corticosteroid with placebo as adjunctive therapy for bacterial corneal ulcers. Patients enrolled in this trial had diverse ulcer severity and on average significantly reduced visual acuity at presentation. PMID:21987581

The steroids for corneal ulcers trial: study design and baseline characteristics.

PubMed

Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V; Ray, Kathryn J; Hong, Kevin C; Oldenburg, Catherine E; Lee, Salena M; Zegans, Michael E; McLeod, Stephen D; Lietman, Thomas M; Acharya, Nisha R

2012-02-01

To provide comprehensive trial methods and baseline data for the Steroids for Corneal Ulcers Trial and to present epidemiological characteristics such as risk factors, causative organisms, and ulcer severity. Baseline data from a 1:1 randomized, placebo-controlled, double-masked clinical trial comparing prednisolone phosphate, 1%, with placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and had been taking moxifloxacin for 48 hours. The primary outcome for the trial is best spectacle-corrected visual acuity at 3 months from enrollment. This report provides comprehensive baseline data, including best spectacle-corrected visual acuity, infiltrate size, microbiological results, and patient demographics, for patients enrolled in the trial. Of 500 patients enrolled, 97% were in India. Two hundred twenty patients (44%) were agricultural workers. Median baseline visual acuity was 0.84 logMAR (Snellen, 20/125) (interquartile range, 0.36-1.7; Snellen, 20/50 to counting fingers). Baseline visual acuity was not significantly different between the United States and India. Ulcers in India had larger infiltrate/scar sizes (P = .04) and deeper infiltrates (P = .04) and were more likely to be localized centrally (P = .002) than ulcers enrolled in the United States. Gram-positive bacteria were the most common organisms isolated from the ulcers (n = 366, 72%). The Steroids for Corneal Ulcers Trial will compare the use of a topical corticosteroid with placebo as adjunctive therapy for bacterial corneal ulcers. Patients enrolled in this trial had diverse ulcer severity and on average significantly reduced visual acuity at presentation. clinicaltrials.gov Identifier: NCT00324168.

Efficacy and safety profile evaluation of acarbose alone and in association with other antidiabetic drugs: a systematic review.

PubMed

Derosa, Giuseppe; Maffioli, Pamela

2012-06-01

Epidemiologic studies have revealed that postprandial hyperglycemia significantly contributes to high glycated hemoglobin concentrations and could be linked to the development of chronic diabetic complications. The purpose of our review was to evaluate the clinical efficacy and safety profile of treatment with acarbose alone and combined with other antidiabetic drugs. A systematic search strategy was developed to identify randomized controlled trials included in MEDLINE and the Cochrane Register of Controlled Trials. The terms acarbose, α-glucosidase inhibitors, type 2 diabetes, adverse events, combination therapy, and postprandial glucose were incorporated into an electronic search strategy that included the Dickersin filter for randomized controlled trials. To qualify for inclusion, clinical trials had to be randomized trials comparing treatment with acarbose at any dosage with any other antidiabetic drug in patients with type 2 diabetes mellitus or impaired glucose tolerance. Eligible trials had to present results on glycemic control or adverse events. Trial participants needed to be affected by type 2 diabetes mellitus or have impaired glucose tolerance, and the intervention had to include acarbose at any dosage as monotherapy or combined with other antidiabetic drugs. A validated 3-item scale was used to evaluate the overall reporting quality of the trials selected for inclusion in the present review. Nineteen trials were included. Treatment with acarbose significantly reduced glycated hemoglobin levels when given as monotherapy and as an add-on to other antidiabetic drug treatment (P < 0.0001). Acarbose treatment was effective in patients with uncontrolled type 2 diabetes and in patients with apparently good metabolic control owing to its positive effect on postprandial hyperglycemia (P < 0.0001). Treatment with acarbose seemed to improve the lipid profile (P < 0.05), reduce circulating levels of cell adhesion molecules (P < 0.05), reduce intima-media thickness progression (P = 0.01), and reverse impaired glucose tolerance to normal glucose tolerance (P < 0.0001). When current therapy is not adequate to obtain glycemic control, acarbose could be an option as monotherapy and as an add-on to other antidiabetic drug treatment, especially when postprandial hyperglycemia is the main concern. Long-term studies are needed to determine whether the effects observed with acarbose use are maintained over the years. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Interventions for enhancing consumers' online health literacy.

PubMed

Car, Josip; Lang, Britta; Colledge, Anthea; Ung, Chuin; Majeed, Azeem

2011-06-15

Access to health information is critical to enable consumers to participate in decisions on health. Increasingly, such information is accessed via the internet, but a number of barriers prevent consumers making effective use of it. These barriers include inadequate skills to search, evaluate and use the information. It has not yet been demonstrated whether training consumers to use the internet for health information can result in positive health outcomes. To assess the effects of interventions for enhancing consumers' online health literacy (skills to search, evaluate and use online health information). We searched: the Cochrane Consumers and Communication Review Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1 2008); MEDLINE (Ovid); EMBASE (Ovid); CINAHL (Dialog); ERIC (CSA Illumina); LISA (CSA Illumina); PsycINFO (Ovid); Index to scientific and technical proceedings; SIGLE; ASLIB Index to Theses; ProQuest Dissertation Abstracts; National Research Register/UK CRN Portfolio database; Current Controlled Trials - MetaRegister of Controlled Trials. We searched all databases for the period January 1990 to March 2008. Randomised controlled trials (RCTs), cluster RCTs and associated economic evaluations, quasi-RCTs, interrupted time series analyses, and controlled before and after (CBA) studies assessing interventions to enhance consumers' online health literacy, in any language. Two review authors independently selected studies for inclusion, assessed their quality and extracted data. We contacted study authors for clarification and to seek missing data. We presented results as a narrative and tabular summary, and calculated mean differences where appropriate. We included two studies: one randomised controlled trial (RCT) and one controlled before and after (CBA) study with a combined total of 470 participants. The RCT compared internet health information classes with patient education classes for participants with HIV infection. Only the RCT, which we rated as having a moderate risk of bias, reported statistically significant positive effects for primary outcomes related to online health literacy in the intervention group, for the following outcomes: 'Self-efficacy for health information seeking', 'health information evaluation skills' and the 'number of times the patient discussed online information with a health provider'. The CBA, which we rated as having a high risk of bias, compared internet health information classes with a control group receiving no intervention among healthy adults aged 50+. It showed significant positive changes only in a secondary (behavioural) outcome in the intervention group, regarding the readiness to adopt the internet as a tool for preventive health information. No adverse effects were reported.There is low quality evidence that such interventions may improve some outcomes relevant to online health literacy in certain populations. Due to the small number of studies and their variable methodological quality, the evidence is too weak to draw any conclusions about implications for the design and delivery of interventions for online health literacy. There is a need for well-designed RCTs to investigate the effects of such interventions. These should involve different participants (in terms of disease status, age, socio-economic group and gender) to analyse the extent to which online health literacy reduces a barrier to using the internet for health information. Trials should be conducted in different settings and should examine interventions to enhance consumers' online health literacy (search, appraisal and use of online health information) like internet training courses, measuring outcomes up to at least one year after the intervention to estimate the sustainability of the intervention effects.

Conditioned inhibition in the spatial domain.

PubMed

Sansa, J; Rodrigo, T; Santamaría, J J; Manteiga, R D; Chamizo, V D

2009-10-01

Using a variation on the standard procedure of conditioned inhibition (Trials A+ and AX-), rats (Rattus norvegicus) in a circular pool were trained to find a hidden platform that was located in a specific spatial position in relation to 2 individual landmarks (Trials A --> platform and B --> platform; Experiments 1a and 1b) and to 2 configurations of landmarks (Trials ABC --> platform and FGH --> platform; Experiment 2a). The rats also underwent inhibitory trials (Experiment 1: Trials AZ --> no platform; Experiment 2a: Trials CDE --> no platform) interspersed with these excitatory trials. In both experiments, subsequent test trials without the platform showed both a summation effect and retardation of excitatory conditioning, and in Experiment 2a rats learned to avoid the CDE quadrant over the course of the experiment. Two further experiments established that these results could not be attributed to any difference in salience between the conditioned inhibitors and the control stimuli. All these results contribute to the growing body of evidence consistent with the idea that there is a general mechanism of learning that is associative in nature. PsycINFO Database Record (c) 2009 APA, all rights reserved.

Happy@Work: protocol for a web-based randomized controlled trial to improve mental well-being among an Asian working population

PubMed Central

2014-01-01

Background Mental health issues pose a serious concern in the workplace for the huge productivity loss and financial burden associated with it. Unlike the traditional ‘fixing-what-is-wrong’ approach, positive psychology offers a less-stigmatized way to promote mental health. Psychological capital, a concept originated from positive psychology, has been proven effective in improving mental well-being and work performance. However, little evidence exists for its implementation among Asian working population or its cost-benefit for organizations adopting such promotion strategy. The current study is designed to assess the protective effects of a web-based psychology capital intervention among Hong Kong working population on individuals’ mental health and work performance, as well as organizations’ return-on-investment. Methods/Design A two-arm randomized controlled trial design will be adopted. Eligible working adults will be randomly allocated to either the intervention group or the waiting-list control group, with 177 participants in each arm. The intervention, which consists of four web-based training sessions, each targeting one of the psychological capital components (hope, efficacy, optimism and resilience), will be implemented over a 4-week period. On-line surveys will assess the participants in each group at baseline, intervention completion, 1 and 3 months after the completion. The primary outcome is individuals’ psychological capital level; secondary outcomes include individuals’ well-being, depressive symptoms, work engagement and productivity. Return-on-investment will be calculated from the employers’ perspective based on productivity gain, savings in medical expenditure, as well as operation and time costs. Analysis will follow the intention-to-treat principle. Discussion This is the first experimental study that explores the applicability of psychological capital development among Asian population. Through investigating changes in individuals’ work productivity from absenteeism and presenteeism, this will be one of the few studies that quantify productivity gains from any type of mental health promotion. By demonstrating effectiveness in improving mental well-being and a positive return-on-investment rate, the study may help convince more uptake of similar positive psychology interventions at workplace in Asia and elsewhere. Trail Registration Number (assigned by Centre for Clinical Trials, Clinical Trials Registry, The Chinese University of Hong Kong): CUHK_CCT00396. Registration Date: 2014/02/13 PMID:24997007

Nudging socially isolated people towards well-being with the ‘Happiness Route’: design of a randomized controlled trial for the evaluation of a happiness-based intervention

PubMed Central

2013-01-01

Background The Happiness Route is an innovative intervention that uses a happiness-based approach for people with an accumulation of risk factors for low well-being: socially isolated people with health impairments and a low socioeconomic status. The goal of this intervention is to improve well-being by engaging participants in intrinsically motivated activities with methods from positive psychology. We hypothesize that the primary outcome measure, emotional, social and psychological well-being of participants of the Happiness Route, will increase in comparison to the traditional and commonly-used problem-based approach. Secondary outcome measures are health-related quality of life, psychosocial functioning and health care consumption. Methods and design Participants will be socially isolated people with health problems and a low socioeconomic status. Participants will be recruited in ten Dutch communities and candidates will be signed up by intermediaries, professionals from the health and social sector. Randomly assigned, half of the participants will follow the Happiness Route and half of the participants will follow the active, problem-focused control group ‘Customized Care’. In total, 256 participants will be included. In both conditions, participants will receive counseling sessions from trained counselors. In the control group, participants will talk about their problems and the care they get and counselors help to optimize their care. In the Happiness Route, the counselor ask questions such as “How do you want to live your life?”. The intervention helps people to find their ‘passion’, i.e., a positive goal-engaged and intrinsically motivated activity. It enables them to follow their passion through by a once-only personal happiness budget (maximal €500). We use well-validated and reliable questionnaires to measure primary and secondary outcome measures at baseline, directly after the intervention and at a nine-month follow-up. Discussion Shortcomings of earlier intervention studies in positive psychology will be tackled with this study, such as having a target group who is especially vulnerable for low well-being. The practice-based setting is especially interesting, as it can give valuable insights in how positive psychology interventions work in practice, but can also give rise to several challenges. Trial registration Dutch Trial Register, trial registration number TC=3377NTR. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3377. PMID:24053566

Happy@Work: protocol for a web-based randomized controlled trial to improve mental well-being among an Asian working population.

PubMed

Yuan, Qi; Liu, Su; Tang, Szehang; Zhang, Dexing

2014-07-04

Mental health issues pose a serious concern in the workplace for the huge productivity loss and financial burden associated with it. Unlike the traditional 'fixing-what-is-wrong' approach, positive psychology offers a less-stigmatized way to promote mental health. Psychological capital, a concept originated from positive psychology, has been proven effective in improving mental well-being and work performance. However, little evidence exists for its implementation among Asian working population or its cost-benefit for organizations adopting such promotion strategy. The current study is designed to assess the protective effects of a web-based psychology capital intervention among Hong Kong working population on individuals' mental health and work performance, as well as organizations' return-on-investment. A two-arm randomized controlled trial design will be adopted. Eligible working adults will be randomly allocated to either the intervention group or the waiting-list control group, with 177 participants in each arm. The intervention, which consists of four web-based training sessions, each targeting one of the psychological capital components (hope, efficacy, optimism and resilience), will be implemented over a 4-week period. On-line surveys will assess the participants in each group at baseline, intervention completion, 1 and 3 months after the completion. The primary outcome is individuals' psychological capital level; secondary outcomes include individuals' well-being, depressive symptoms, work engagement and productivity. Return-on-investment will be calculated from the employers' perspective based on productivity gain, savings in medical expenditure, as well as operation and time costs. Analysis will follow the intention-to-treat principle. This is the first experimental study that explores the applicability of psychological capital development among Asian population. Through investigating changes in individuals' work productivity from absenteeism and presenteeism, this will be one of the few studies that quantify productivity gains from any type of mental health promotion. By demonstrating effectiveness in improving mental well-being and a positive return-on-investment rate, the study may help convince more uptake of similar positive psychology interventions at workplace in Asia and elsewhere. Number (assigned by Centre for Clinical Trials, Clinical Trials Registry, The Chinese University of Hong Kong): CUHK_CCT00396. Registration Date: 2014/02/13.

Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial.

PubMed

Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

2016-11-10

To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Epilepsy clinics in 1 English National Health Service (NHS) Trust. Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. ISRCTN80067039. 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/.

A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

PubMed Central

2010-01-01

Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years) improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a universal parenting interventions for the promotion of protective factors associated with adolescent wellbeing and will add to the literature regarding the relationships between parent, parenting and adolescent factors. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12609000194268. PMID:20723219

Structure and content components of self-management interventions that improve health-related quality of life in people with inflammatory bowel disease: a systematic review, meta-analysis and meta-regression.

PubMed

Tu, Wenjing; Xu, Guihua; Du, Shizheng

2015-10-01

The purpose of this review was to identify and categorise the components of the content and structure of effective self-management interventions for patients with inflammatory bowel disease. Inflammatory bowel diseases are chronic gastrointestinal disorders impacting health-related quality of life. Although the efficacy of self-management interventions has been demonstrated in previous studies, the most effective components of the content and structure of these interventions remain unknown. A systematic review, meta-analysis and meta-regression of randomised controlled trials was used. A systematic search of six electronic databases, including Pubmed, Embase, Cochrane central register of controlled trials, Web of Science, Cumulative Index of Nursing and Allied Health Literature and Chinese Biomedical Literature Database, was conducted. Content analysis was used to categorise the components of the content and structure of effective self-management interventions for inflammatory bowel disease. Clinically important and statistically significant beneficial effects on health-related quality of life were explored, by comparing the association between effect sizes and various components of self-management interventions such as the presence or absence of specific content and different delivery methods. Fifteen randomised controlled trials were included in this review. Distance or remote self-management interventions demonstrated a larger effect size. However, there is no evidence for a positive effect associated with specific content component of self-management interventions in adult patients with inflammatory bowel disease in general. The results showed that self-management interventions have positive effects on health-related quality of life in patients with inflammatory bowel disease, and distance or remote self-management programmes had better outcomes than other types of interventions. This review provides useful information to clinician and researchers when determining components of effective self-management programmes for patients with inflammatory bowel disease. More high-quality randomised controlled trials are needed to test the results. © 2015 John Wiley & Sons Ltd.

Computerized clinical decision support systems for drug prescribing and management: a decision-maker-researcher partnership systematic review.

PubMed

Hemens, Brian J; Holbrook, Anne; Tonkin, Marita; Mackay, Jean A; Weise-Kelly, Lorraine; Navarro, Tamara; Wilczynski, Nancy L; Haynes, R Brian

2011-08-03

Computerized clinical decision support systems (CCDSSs) for drug therapy management are designed to promote safe and effective medication use. Evidence documenting the effectiveness of CCDSSs for improving drug therapy is necessary for informed adoption decisions. The objective of this review was to systematically review randomized controlled trials assessing the effects of CCDSSs for drug therapy management on process of care and patient outcomes. We also sought to identify system and study characteristics that predicted benefit. We conducted a decision-maker-researcher partnership systematic review. We updated our earlier reviews (1998, 2005) by searching MEDLINE, EMBASE, EBM Reviews, Inspec, and other databases, and consulting reference lists through January 2010. Authors of 82% of included studies confirmed or supplemented extracted data. We included only randomized controlled trials that evaluated the effect on process of care or patient outcomes of a CCDSS for drug therapy management compared to care provided without a CCDSS. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive. Sixty-five studies met our inclusion criteria, including 41 new studies since our previous review. Methodological quality was generally high and unchanged with time. CCDSSs improved process of care performance in 37 of the 59 studies assessing this type of outcome (64%, 57% of all studies). Twenty-nine trials assessed patient outcomes, of which six trials (21%, 9% of all trials) reported improvements. CCDSSs inconsistently improved process of care measures and seldomly improved patient outcomes. Lack of clear patient benefit and lack of data on harms and costs preclude a recommendation to adopt CCDSSs for drug therapy management.

Self-stigma and empowerment in combined-CMHA and consumer-run services: two controlled trials.

PubMed

Segal, Steven P; Silverman, Carol J; Temkin, Tanya L

2013-10-01

Self-help agencies (SHAs) are consumer-operated service organizations managed as participatory democracies involving members in all management tasks. Hierarchically organized board- and staff-run consumer-operated service programs (BSR-COSPs) are consumer managed, but they afford members less decision-making power. This study considered the relative effectiveness of SHAs and BSR-COSPs working jointly with community mental health agencies (CMHAs) and the role of organizational empowerment in reducing self-stigma. Clients seeking CMHA services were assigned in separate randomized controlled trials to a trial of combined SHA and CMHA services versus regular CMHA services (N=505) or to a trial of combined BSR-COSP and CMHA services versus regular CMHA services (N=139). Self-stigma, organizational empowerment, and self-efficacy were assessed at baseline and eight months with the Attitudes Toward Persons With Mental Illness Scale, the Organizationally Mediated Empowerment Scale, and the Self-Efficacy Scale. Outcomes were evaluated with fully recursive path analysis models. SHA-CMHA participants experienced greater positive change in self-stigma than CMHA-only participants, a result attributable to participation in the combined condition (b=1.20, p=.016) and increased organizational empowerment (b=.27, p=.003). BSR-COSP-CMHA participants experienced greater negative change in self-stigma than CMHA-only participants, a result attributable to participation in the combined service (b=-4.73, p=.031). In the SHA-CMHA trial, participants showed positive change in self-efficacy, whereas the change among BSR-COSP-CMHA participants was negative. Differential organizational empowerment efforts in the SHA and BSR-COSP appeared to account for the differing outcomes. Members experienced reduced self-stigma and increases in self-efficacy when they were engaged in responsible roles.

Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood

PubMed Central

Edmonds, Barrie; Swift, Judy Anne; Siriwardena, Aloysius Niroshan; Weng, Stephen; Nathan, Dilip; Glazebrook, Cris

2016-01-01

Abstract The risk factors for childhood overweight and obesity are known and can be identified antenatally or during infancy, however, the majority of effective interventions are designed for older children. This review identified interventions designed to reduce the risk of overweight/obesity that were delivered antenatally or during the first 2 years of life, with outcomes reported from birth to 7 years of age. Six electronic databases were searched for papers reporting randomised controlled trials of interventions published from January 1990 to September 2013. A total of 35 eligible studies were identified, describing 27 unique trials of which 24 were behavioural and three were non‐behavioural. The 24 behavioural trials were categorised by type of intervention: (1) nutritional and/or responsive feeding interventions targeted at parents of infants, which improved feeding practices and had some impact on child weight (n = 12); (2) breastfeeding promotion and lactation support for mothers, which had a positive effect on breastfeeding but not child weight (n = 5); (3) parenting and family lifestyle (n = 4); and (4) maternal health (n = 3) interventions that had some impact on feeding practices but not child weight. The non‐behavioural trials comprised interventions manipulating formula milk composition (n = 3). Of these, lower/hydrolysed protein formula milk had a positive effect on weight outcomes. Interventions that aim to improve diet and parental responsiveness to infant cues showed most promise in terms of self‐reported behavioural change. Despite the known risk factors, there were very few intervention studies for pregnant women that continue during infancy which should be a priority for future research. PMID:25894857

Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood.

PubMed

Redsell, Sarah A; Edmonds, Barrie; Swift, Judy Anne; Siriwardena, Aloysius Niroshan; Weng, Stephen; Nathan, Dilip; Glazebrook, Cris

2016-01-01

The risk factors for childhood overweight and obesity are known and can be identified antenatally or during infancy, however, the majority of effective interventions are designed for older children. This review identified interventions designed to reduce the risk of overweight/obesity that were delivered antenatally or during the first 2 years of life, with outcomes reported from birth to 7 years of age. Six electronic databases were searched for papers reporting randomised controlled trials of interventions published from January 1990 to September 2013. A total of 35 eligible studies were identified, describing 27 unique trials of which 24 were behavioural and three were non-behavioural. The 24 behavioural trials were categorised by type of intervention: (1) nutritional and/or responsive feeding interventions targeted at parents of infants, which improved feeding practices and had some impact on child weight (n = 12); (2) breastfeeding promotion and lactation support for mothers, which had a positive effect on breastfeeding but not child weight (n = 5); (3) parenting and family lifestyle (n = 4); and (4) maternal health (n = 3) interventions that had some impact on feeding practices but not child weight. The non-behavioural trials comprised interventions manipulating formula milk composition (n = 3). Of these, lower/hydrolysed protein formula milk had a positive effect on weight outcomes. Interventions that aim to improve diet and parental responsiveness to infant cues showed most promise in terms of self-reported behavioural change. Despite the known risk factors, there were very few intervention studies for pregnant women that continue during infancy which should be a priority for future research. © 2015 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.

Treating obstructive sleep apnea in adults with epilepsy

PubMed Central

Malow, B A.; Foldvary-Schaefer, N; Vaughn, B V.; Selwa, L M.; Chervin, R D.; Weatherwax, K J.; Wang, L; Song, Y

2008-01-01

Objective: Small uncontrolled series suggest that treatment of obstructive sleep apnea (OSA) in patients with epilepsy may improve seizure control. Prior to conducting a definitive randomized controlled trial, we addressed critical design issues in a pilot study. Methods: We identified a cohort of adult patients with medically refractory epilepsy and coexisting OSA, documented by polysomnography (PSG). After an 8-week baseline period, subjects with OSA were randomized to therapeutic or sham continuous positive airway pressure (CPAP) for 10 weeks. Subjects maintained seizure calendars and antiepileptic drug dosages were held constant. Results: Sixty-eight subjects with suspected OSA were enrolled and 35 subjects randomized to therapeutic CPAP (22 subjects) or sham (13 subjects) CPAP. Male gender and an elevated sleep apnea questionnaire score were predictive of OSA on PSG. Nineteen subjects in the therapeutic group and all 13 subjects in the sham group completed the trial. Baseline apnea-hypopnea index (AHI) and CPAP adherence were comparable between groups. A significant reduction in AHI was observed in the therapeutic CPAP group as compared to the sham group. Subjects, study coordinators, and principal investigators were unable to predict treatment allocation. Conclusions: This pilot study provided critical information related to study design and feasibility for planning a comprehensive trial to test the hypothesis that treating obstructive sleep apnea in patients with epilepsy improves seizure control. GLOSSARY AEDs = antiepileptic drugs; AHI = apnea-hypopnea index; BMI = body mass index; CPAP = continuous positive airway pressure; OSA = obstructive sleep apnea; PSG = polysomnography. PMID:18711110

The effects of the Make a Wish intervention on psychiatric symptoms and health-related quality of life of children with cancer: a randomised controlled trial.

PubMed

Shoshani, Anat; Mifano, Keren; Czamanski-Cohen, Johanna

2016-05-01

Children with life-threatening medical conditions frequently undergo invasive medical procedures that may elicit anxiety and distress. However, there are few empirically validated interventions that reduce mental health symptoms and increase the resilience of children during the acute stages of illness. This study aimed to evaluate the efficacy of the Make a Wish intervention for children with life-threatening cancer. The design was a wait-list-controlled trial with two parallel groups. Sixty-six children aged 5-12 with an initial diagnosis of life-threatening cancer were identified and randomly assigned to the Make a Wish intervention (n = 32) or a wait-list control group (n = 34). Children completed measures of psychiatric and health-related symptoms, positive and negative affect, hope, and optimism pre-intervention and post-intervention. After baseline data collection, children were interviewed and made an authentic wish that they wanted to come true. These wishes were made possible 5-6 months after baseline data collection, to fuel anticipation and excitement over the wish-fulfillment event. The post-intervention assessment point was 5 weeks after wish fulfillment (approximately 7 months after baseline data collection). Children in the intervention group exhibited a significant reduction in general distress (d = 0.54), depression (d = 0.70), and anxiety symptoms (d = 0.41), improved health-related quality of life (d = 0.59), hope (d = 0.71), and positive affect (d = 0.80) compared to decrease in positive affect and no significant changes in the other measures in the control group. These findings emphasize the role of hope and positive emotions in fostering the well-being of children who suffer from serious illnesses.

Randomized controlled trial evaluating the effect of an interactive group counseling intervention for HIV-positive women on prenatal depression and disclosure of HIV status.

PubMed

Kaaya, Sylvia F; Blander, Jeffrey; Antelman, Gretchen; Cyprian, Fileuka; Emmons, Karen M; Matsumoto, Kenji; Chopyak, Elena; Levine, Michelle; Smith Fawzi, Mary C

2013-01-01

The objective of the study was to assess the effectiveness of group counseling, using a problem-solving therapy approach, on reducing depressive symptoms and increasing prenatal disclosure rates of HIV status among HIV-positive pregnant women living in Dar es Salaam, Tanzania. A randomized controlled trial was performed comparing a six-week structured nurse-midwife facilitated psychosocial support group with the standard of care. Sixty percent of women in the intervention group were depressed post-intervention, versus 73% in the control group [Relative Risk (RR) = 0.82, 95% confidence interval (CI): 0.67-1.01, p=0.066]. HIV disclosure rates did not differ across the two study arms. However, among those women who disclosed, there was a significantly higher level of overall personal satisfaction with the response to disclosure from family and friends among women in the treatment (88%) compared to the control group (62%; p=0.004). The results indicate reductions in the level of depressive symptoms comparable with major depressive disorder (MDD) for HIV-positive pregnant women participating in a group counseling intervention. Although the psychosocial group counseling did not significantly increase disclosure rates, an improvement in the level of personal satisfaction resulting from disclosure was associated with the intervention. This suggests that the counseling sessions have likely reduced the burden of depression and helped clients better manage partner reactions to disclosure. Public agencies and non-governmental organizations working in Tanzania and similar settings should consider offering structured psychosocial support groups to HIV-positive pregnant women to prevent poor mental health outcomes, promote early childhood development, and potentially impact HIV-related disease outcomes in the long term.

Feasibility and effectiveness of a web-based positive psychology program for youth mental health: randomized controlled trial.

PubMed

Manicavasagar, Vijaya; Horswood, Deserae; Burckhardt, Rowan; Lum, Alistair; Hadzi-Pavlovic, Dusan; Parker, Gordon

2014-06-04

Youth mental health is a significant public health concern due to the high prevalence of mental health problems in this population and the low rate of those affected seeking help. While it is increasingly recognized that prevention is better than cure, most youth prevention programs have utilized interventions based on clinical treatments (eg, cognitive behavioral therapy) with inconsistent results. This study explores the feasibility of the online delivery of a youth positive psychology program, Bite Back, to improve the well-being and mental health outcomes of Australian youth. Further aims were to examine rates of adherence and attrition, and to investigate the program's acceptability. Participants (N=235) aged 12-18 years were randomly assigned to either of two conditions: Bite Back (n=120) or control websites (n=115). The Bite Back website comprised interactive exercises and information across a variety of positive psychology domains; the control condition was assigned to neutral entertainment-based websites that contained no psychology information. Participants in both groups were instructed to use their allocated website for 6 consecutive weeks. Participants were assessed pre- and postintervention on the Depression Anxiety Stress Scale-Short form (DASS-21) and the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). Of the 235 randomized participants, 154 (65.5%) completed baseline and post measures after 6 weeks. Completers and dropouts were equivalent in demographics, the SWEMWBS, and the depression and anxiety subscales of the DASS-21, but dropouts reported significantly higher levels of stress than completers. There were no differences between the Bite Back and control conditions at baseline on demographic variables, DASS-21, or SWEMWBS scores. Qualitative data indicated that 49 of 61 Bite Back users (79%) reported positive experiences using the website and 55 (89%) agreed they would continue to use it after study completion. Compared to the control condition, participants in the Bite Back condition with high levels of adherence (usage of the website for 30 minutes or more per week) reported significant decreases in depression and stress and improvements in well-being. Bite Back users who visited the site more frequently (≥3 times per week) reported significant decreases in depression and anxiety and improvements in well-being. No significant improvements were found among Bite Back users who demonstrated low levels of adherence or who used the website less frequently. Results suggest that using an online positive psychology program can decrease symptoms of psychopathology and increase well-being in young people, especially for those who use the website for 30 minutes or longer per week or more frequently (≥3 times per week). Acceptability of the Bite Back website was high. These findings are encouraging and suggest that the online delivery of positive psychology programs may be an alternate way to address mental health issues and improve youth well-being nationally. Australian New Zealand Clinical Trials Registry: ACTRN1261200057831; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362489 (Archived by Webcite at http://www.webcitation.org/6NXmjwfAy).

Top-down suppression of incompatible motor activations during response selection under conflict.

PubMed

Klein, Pierre-Alexandre; Petitjean, Charlotte; Olivier, Etienne; Duque, Julie

2014-02-01

Top-down control is critical to select goal-directed actions in changeable environments, particularly when several options compete for selection. This control system is thought to involve a mechanism that suppresses activation of unwanted response representations. We tested this hypothesis, in humans, by measuring motor-evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) in a left finger muscle during motor preparation in an adapted Eriksen flanker task. Subjects reported, by a left or right button-press, the orientation of a left- or right-facing central arrow, flanked by two distractor arrows on each side. Central and peripheral arrows either pointed in the same (congruent trial) or in the opposite direction (incongruent trial). Top-down control was manipulated by changing the probability of congruent and incongruent trials in a given block. In the "mostly incongruent" (MI) blocks, 80% of trials were incongruent, producing a context in which subjects strongly anticipated that they would have to face conflict. In the "mostly congruent" (MC) blocks, 80% of trials were congruent and thus subjects barely anticipated conflict in that context. Thus, we assume that top-down control was stronger in the MI than in the MC condition. Accordingly, subjects displayed a lower error rate and shorter reaction times for the incongruent trials in the MI context than for similar trials in the MC context. More interestingly, we found that top-down control specifically reduced activation of the incompatible motor representation during response selection under high conflict. That is, when the central arrow specified a right hand response, left (non-selected) MEPs became smaller in the MI than in the MC condition, but only for incongruent trials, and this measure was positively correlated with performance. In contrast, MEPs elicited in the non-selected hand during congruent trials, or during all trials in which the left hand was selected, tended to increase more after the imperative signal in the MI than the MC condition. Another important observation was that, overall, MEPs were already strongly suppressed at the onset of the imperative signal and that this effect was particularly pronounced in the MI context. Hence, suppression of motor excitability seems to be a key component of conflict resolution. © 2013.

Tailored nutritional guidance for home-dwelling AD families: the Feasibility of and Elements Promoting Positive Changes in Diet (NuAD-Trial).

PubMed

Puranen, T M; Pitkala, K H; Suominen, M H

2015-04-01

To describe the process and feasibility of our randomised, controlled intervention study (NuAD trial) that positively affected the nutrition and quality of life, and prevented falls of home-dwelling persons with Alzheimer disease (AD). This qualitative study comprised 40 persons with AD and spousal caregivers of our trial. Our intervention during one year involved tailored nutritional guidance for these couples. The nutritionist's field notes (about 100 pages) and the participant feedback questionnaires (N = 28) served to analyse the feasibility of intervention, factors promoting the application of intervention and challenges hindering it. Thematic content analysis served to analyse our data with the grounded theory approach. We identified several positive elements promoting better nutrition: positive attitudes on nutrition to participants including a participant-centred approach, positive feedback, findings of food diaries and practical suggestions. Home visits by the nutritionist were convenient and participants felt that someone cares. Group meetings which included protein-rich snacks strengthened the nutritional message by enabling discussions and socialising. The oral nutritional supplements (ONS) helped participants to regain their energy and to motivate them to exercise and make changes in their diets. Obstacles to making changes in diets included participants' false ideas about nutrition, especially with regard to weight gain. Health problems and functional limitations hampered food management, and some families had inveterate eating habits. The positive feedback from participants indicated the feasibility of our tailored nutritional guidance. Assessment-based, tailored nutritional guidance implemented with a personal and positive approach may inspire and empower AD families to make positive changes in their diets, leading them to improved nutrition and quality of life.

Automatic control of tracheal tube cuff pressure in ventilated patients in semirecumbent position: a randomized trial.

PubMed

Valencia, Mauricio; Ferrer, Miquel; Farre, Ramon; Navajas, Daniel; Badia, Joan Ramon; Nicolas, Josep Maria; Torres, Antoni

2007-06-01

The aspiration of subglottic secretions colonized by bacteria pooled around the tracheal tube cuff due to inadvertent deflation (<20 cm H2O) of the cuff plays a relevant role in the pathogenesis of ventilator-associated pneumonia. We assessed the efficacy of an automatic, validated device for the continuous regulation of tracheal tube cuff pressure in preventing ventilator-associated pneumonia. Prospective randomized controlled trial. Respiratory intensive care unit and general medical intensive care unit. One hundred and forty-two mechanically ventilated patients (age, 64 +/- 17 yrs; Acute Physiology and Chronic Health Evaluation II score, 18 +/- 6) without pneumonia or aspiration at admission. Within 24 hrs of intubation, patients were randomly allocated to undergo continuous regulation of the cuff pressure with the automatic device (n = 73) or routine care of the cuff pressure (control group, n = 69). Patients remained in a semirecumbent position in bed. The primary end point variable was the incidence of ventilator-associated pneumonia. Main causes for intubation were decreased consciousness (43, 30%) and exacerbation of chronic respiratory diseases (38, 27%). Cuff pressure <20 cm H2O was more frequently observed in the control than the automatic group (45.3 vs. 0.7% determinations, p < .001). However, the rate of ventilator-associated pneumonia with clinical criteria (16, 22% vs. 20, 29%) and microbiological confirmation (11, 15% vs. 10, 15%), the distribution of early and late onset, the causative microorganisms, and intensive care unit (20, 27% vs. 16, 23%) and hospital mortality (30, 41% vs. 23, 33%) were similar for the automatic and control groups, respectively. Cuff pressure is better controlled with the automatic device. However, it did not result in additional benefits to the semirecumbent position in preventing ventilator-associated pneumonia.

The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study.

PubMed

Midgley, Nick; Isaacs, Danny; Weitkamp, Katharina; Target, Mary

2016-07-28

This descriptive study aimed to investigate adolescents' motivations for participating in a randomised controlled trial (RCT), to explore the understanding that the young people had regarding a number of aspects of the trial design, to examine whether or not they found participation in the trial to be acceptable and what affected this, and to identify whether and how the young people felt that their participation in the RCT impacted on their experience of therapy and on therapeutic change. Seventy-six adolescents who were taking part in a large-scale RCT to evaluate the clinical and cost effectiveness of psychological therapies for depression were interviewed at two time-points after completing therapy. The semi-structured interviews, which included a focus on the young people's experience of the research study, were analysed using framework analysis. The vast majority of adolescents found it acceptable to participate in the clinical trial, and many agreed to participate for reasons of 'conditional altruism'. However consent was often given without great understanding of the key elements of the trial, including the difference between treatment arms and the randomisation process. Although the adolescents were largely positive about their experiences from taking part, the study raises questions about whether clinical outcomes may be influenced by participation in the research elements of the trial. Although adolescents are under-represented in clinical trials, those who do participate are generally positive about the experience; however, careful thought needs to be given to key elements of the trial design and the potential impact of the research participation on clinical outcomes. ISRCTN registry, ISRCTN83033550 . Registered on 15 October 2009.

Successful recruitment to trials: findings from the SCIMITAR+ Trial.

PubMed

Peckham, Emily; Arundel, Catherine; Bailey, Della; Callen, Tracy; Cusack, Christina; Crosland, Suzanne; Foster, Penny; Herlihy, Hannah; Hope, James; Ker, Suzy; McCloud, Tayla; Romain-Hooper, Crystal-Bella; Stribling, Alison; Phiri, Peter; Tait, Ellen; Gilbody, Simon

2018-01-19

Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

The efficacy of Protected Mealtimes in hospitalised patients: a stepped wedge cluster randomised controlled trial.

PubMed

Porter, Judi; Haines, Terry P; Truby, Helen

2017-02-07

Protected Mealtimes is an intervention developed to address the problem of malnutrition in hospitalised patients through increasing positive interruptions (such as feeding assistance) whilst minimising unnecessary interruptions (including ward rounds and diagnostic procedures) during mealtimes. This clinical trial aimed to measure the effect of implementing Protected Mealtimes on the energy and protein intake of patients admitted to the subacute setting. A prospective, stepped wedge cluster randomised controlled trial was undertaken across three hospital sites at one health network in Melbourne, Australia. All patients, except those receiving end-of-life care or not receiving oral nutrition, admitted to these wards during the study period participated. The intervention was guided by the British Hospital Caterers Association reference policy on Protected Mealtimes and by principles of implementation science. Primary outcome measures were daily energy and protein intake. The study was powered to determine whether the intervention closed the daily energy deficit between estimated intake and energy requirements measured as 1900 kJ/day in the pilot study for this trial. There were 149 unique participants, including 38 who crossed over from the control to intervention period as the Protected Mealtimes intervention was implemented. In total, 416 observations of 24-hour food intake were obtained. Energy intake was not significantly different between the intervention ([mean ± SD] 6479 ± 2486 kJ/day) and control (6532 ± 2328 kJ/day) conditions (p = 0.88). Daily protein intake was also not significantly different between the intervention (68.6 ± 26.0 g/day) and control (67.0 ± 25.2 g/day) conditions (p = 0.86). The differences between estimated energy/protein requirements and estimated energy/protein intakes were also limited between groups. The adjusted analysis yielded significant findings for energy deficit: (coefficient [robust 95% CI], p value) of -1405 (-2354 to -457), p = 0.004. Variability in implementation across aspects of Protected Mealtimes policy components was noted. The findings of this trial mirror the findings of other observational studies of Protected Mealtimes implementation where nutritional intakes were observed. Very few positive improvements to nutritional intake have been identified as a result of Protected Mealtimes implementation. Instead of this intervention, approaches with a greater level of evidence for improving nutritional outcomes, such as mealtime assistance, other food-based approaches and the use of oral nutrition support products to supplement oral diet, should be considered in the quest to reduce hospital malnutrition. Australian New Zealand Clinical Trials Registry: ACTRN12614001316695 ; registered 16th December 2014.

European Marketing Authorizations Granted Based on a Single Pivotal Clinical Trial: The Rule or the Exception?

PubMed

Morant, Anne Vinther; Vestergaard, Henrik Tang

2018-07-01

A minimum of two positive, adequate, and well-controlled clinical trials has historically been the gold standard for providing substantial evidence to support regulatory approval of a new medicine. Nevertheless, the present analysis of European Marketing Authorizations granted between 2012 and 2016 showed that 45% of new active substances were approved based on a single pivotal clinical trial. For therapeutic areas such as oncology and cardiovascular diseases, approvals based on a single pivotal trial are the rule rather than the exception, whereas new medicines within the nervous system area were generally supported by two or more pivotal trials. While overall similar trends have been observed in the US, the recent US Food and Drug Administration approvals of nervous system medicines based on a single pivotal trial suggest that a case-by-case scientific evaluation of the totality of evidence is increasingly applied to facilitate faster access of new medicines to patients suffering from serious diseases. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Synergies in the space of control variables within the equilibrium-point hypothesis.

PubMed

Ambike, S; Mattos, D; Zatsiorsky, V M; Latash, M L

2016-02-19

We use an approach rooted in the recent theory of synergies to analyze possible co-variation between two hypothetical control variables involved in finger force production based on the equilibrium-point (EP) hypothesis. These control variables are the referent coordinate (R) and apparent stiffness (C) of the finger. We tested a hypothesis that inter-trial co-variation in the {R; C} space during repeated, accurate force production trials stabilizes the fingertip force. This was expected to correspond to a relatively low amount of inter-trial variability affecting force and a high amount of variability keeping the force unchanged. We used the "inverse piano" apparatus to apply small and smooth positional perturbations to fingers during force production tasks. Across trials, R and C showed strong co-variation with the data points lying close to a hyperbolic curve. Hyperbolic regressions accounted for over 99% of the variance in the {R; C} space. Another analysis was conducted by randomizing the original {R; C} data sets and creating surrogate data sets that were then used to compute predicted force values. The surrogate sets always showed much higher force variance compared to the actual data, thus reinforcing the conclusion that finger force control was organized in the {R; C} space, as predicted by the EP hypothesis, and involved co-variation in that space stabilizing total force. Copyright © 2015 IBRO. Published by Elsevier Ltd. All rights reserved.

Synergies in the space of control variables within the equilibrium-point hypothesis

PubMed Central

Ambike, Satyajit; Mattos, Daniela; Zatsiorsky, Vladimir M.; Latash, Mark L.

2015-01-01

We use an approach rooted in the recent theory of synergies to analyze possible co-variation between two hypothetical control variables involved in finger force production based in the equilibrium-point hypothesis. These control variables are the referent coordinate (R) and apparent stiffness (C) of the finger. We tested a hypothesis that inter-trial co-variation in the {R; C} space during repeated, accurate force production trials stabilizes the fingertip force. This was expected to correspond to a relatively low amount of inter-trial variability affecting force and a high amount of variability keeping the force unchanged. We used the “inverse piano” apparatus to apply small and smooth positional perturbations to fingers during force production tasks. Across trials, R and C showed strong co-variation with the data points lying close to a hyperbolic curve. Hyperbolic regressions accounted for over 99% of the variance in the {R; C} space. Another analysis was conducted by randomizing the original {R; C} data sets and creating surrogate data sets that were then used to compute predicted force values. The surrogate sets always showed much higher force variance compared to the actual data, thus reinforcing the conclusion that finger force control was organized in the {R; C} space, as predicted by the equilibrium-point hypothesis, and involved co-variation in that space stabilizing total force. PMID:26701299

Effects of Acute MDMA Intoxication on Mood and Impulsivity: Role of the 5-HT2 and 5-HT1 Receptors

PubMed Central

van Wel, Janelle H. P.; Kuypers, Kim P. C.; Theunissen, Eef L.; Bosker, Wendy M.; Bakker, Katja; Ramaekers, Johannes G.

2012-01-01

MDMA induces positive mood and increases impulse control during intoxication, but only a few studies on the neuropharmacological mechanisms underlying these processes have been conducted. It was hypothesized that pretreatment with 5-HT1 and 5-HT2 receptor blockers would prevent MDMA effects on mood and impulsivity. Subjects (N = 17) participated in a double-blind, placebo controlled, within-subject design involving 6 experimental conditions consisting of pretreatment (T1) and treatment (T2). T1 preceded T2 by 30 minutes. T1–T2 combinations were: placebo-placebo, 20 mg pindolol-placebo, 50 mg ketanserin-placebo, placebo-75 mg MDMA, 20 mg pindolol-75 mg MDMA and 50 mg ketanserin-75 g MDMA. Subjects completed a Profile of Mood States (POMS) questionnaire and several impulsivity tasks (Stop signal task, Matching familiar figures task, Cue dependent reversal learning task) at 1.5 hrs post-treatment. MDMA alone increased both positive (vigor, arousal, friendliness, elation, positive mood) and negative affect (anxiety, confusion) as assessed by the POMS questionnaire. MDMA also increased stop reaction time in the Stop signal task and reaction time in the Matching familiar figures task. Pretreatment with ketanserin blocked MDMA effects on positive affect, but not negative affect. Ketanserin did not influence the effects of MDMA on impulsivity. Pindolol did not interact with MDMA on any of the measures. In conclusion, 5-HT2 receptors mediate positive moods induced by MDMA but not negative moods or impulsivity. 5-HT1 receptors do not appear to be involved in MDMA effects on mood and impulse control. Trial Registration Nederlands Trial Register NTR2352 PMID:22808116

Effect of Platelet-rich Fibrin on Healing of Apicomarginal Defects: A Randomized Controlled Trial.

PubMed

Dhiman, Meenu; Kumar, Suresh; Duhan, Jigyasa; Sangwan, Pankaj; Tewari, Sanjay

2015-07-01

The purpose of this prospective, randomized controlled trial was to evaluate the healing outcomes of platelet-rich fibrin (PRF) in periapical surgeries involving apicomarginal defects and to compare these results with surgeries not using any guided tissue regeneration techniques. Thirty patients with suppurative chronic apical periodontitis and apicomarginal communication were randomly assigned to either the PRF or the control group. Clinical and radiographic parameters including pocket depth (PD), clinical attachment level, gingival marginal position, size of periapical lesion, and percentage reduction of the periapical radiolucency were recorded at baseline and at an interval of 3 months for a period of 12 months. The overall success rate was 83.33%, with a success rate of 86.66% (13 of 15 teeth) for PRF group and 80% (12 of 15 teeth) for control group. Both the groups exhibited a significant reduction in PD, clinical attachment level, gingival marginal position, and size of periapical lesion at 12-month period. No significant differences were observed between the 2 groups for these parameters except PD, which showed a statistically significant reduction in the PRF group (P < .05). The adjunctive use of regenerative techniques may not promote healing of apicomarginal defects of endodontic origin. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Learning Dynamic Control of Body Roll Orientation

PubMed Central

Vimal, Vivekanand Pandey; Lackner, James R.; DiZio, Paul

2016-01-01

Our objective was to examine how the control of orientation is learned in a task involving dynamically balancing about an unstable equilibrium point, the gravitational vertical, in the absence of leg reflexes and muscle stiffness. Subjects (n=10) used a joystick to set themselves to the gravitational vertical while seated in a multi-axis rotation system device (MARS) programmed with inverted pendulum dynamics. The MARS is driven by powerful servomotors and can faithfully follow joystick commands up to 2.5 Hz with a 30 ms latency. To make the task extremely difficult, the pendulum constant was set to 600°/sec2. Each subject participated in 5 blocks of 4 trials, with a trial ending after a cumulative 100 s of balancing, excluding reset times when a subject lost control. To characterize performance and learning, we used metrics derived from joystick movements, phase portraits (joystick deflections vs MARS position and MARS velocity vs angular position), and stabilogram diffusion functions. We found that as subjects improved their balancing performance they did so by making fewer destabilizing joystick movements and reducing the number and duration of joystick commands. The control strategy they acquired involved making more persistent short-term joystick movements, waiting longer before making changes to ongoing motion, and only intervening intermittently. PMID:26525709

Trichuris suis ova in inflammatory bowel disease.

PubMed

Schölmerich, Jürgen

2013-01-01

Some but not all epidemiological studies suggest that helminth infection in childhood protects against development of inflammatory bowel disease (IBD) in later years. In animal models of IBD, helminths have shown protective effects and changed bacterial flora in the gut. Based on these concepts, small trials and series have been published showing some positive effects of Trichuris suis ova in ulcerative colitis and Crohn's disease. Currently, large randomized placebo-controlled trials are under way. Results remain to be awaited in order to clarify a possible role of T. suis ova in the treatment of IBD.

Opisthorchiasis control in Thailand.

PubMed

Jongsuksuntigul, P; Imsomboon, T

2003-11-01

History of opisthorchiasis control started in 1950 as a small scale helminthiasis control program in some high risk areas. Following a number of studies and trial projects of the Faculty of Tropical Medicine, Mahidol University, the national liver fluke control program has been developed and operated under several National Public Health Development Plans. Presently, the program is being operated in some provinces of the Central, and all provinces of the Northeast and North of Thailand. The main strategies for liver fluke control comprise of three interrelated approaches, namely stool examinations and treatment of positive cases with praziquantel for eliminating human host reservoir; health education for a promotion of cooked fish consumption to prevent infection, and the improvement of hygienic defecation for the interruption of disease transmission. Between 1984 and 1987, the positive rate of liver fluke infection was 63.6%. In 1988, the positive rate went down to 35.6%. Following the region wide control program started in 1989, the annual positive rates had subsequently decreased to 9.4% in the year 2001. The prevalence rate was remarkably high in the North and moderately high in the Northeast, while the prevalence in the Central region was considerably low and there was no evidence of disease transmission in the South.

Broadening Participation in the Life Sciences with Social-Psychological Interventions

ERIC Educational Resources Information Center

Tibbetts, Yoi; Harackiewicz, Judith M.; Priniski, Stacy J.; Canning, Elizabeth A.

2016-01-01

Randomized controlled trials (RCTs) have recently documented the positive effects of social-psychological interventions on the performance and retention of underrepresented students in the life sciences. We review two types of social-psychological interventions that address either students' well-being in college science courses or students'…

Effects of a Parenting Intervention on Features of Psychopathy in Children

ERIC Educational Resources Information Center

McDonald, Renee; Dodson, Mary Catherine; Rosenfield, David; Jouriles, Ernest N.

2011-01-01

This study examined whether Project Support, a parenting intervention shown to reduce child conduct problems, also exerts positive effects on features of psychopathy in children. Participants were 66 families (mothers and children) recruited from domestic violence shelters who participated in a randomized controlled trial evaluating Project…

Uptake of community-based, self-collected HPV testing vs. visual inspection with acetic acid for cervical cancer screening in Kampala, Uganda: preliminary results of a randomised controlled trial.

PubMed

Moses, Erin; Pedersen, Heather N; Mitchell, Sheona M; Sekikubo, Musa; Mwesigwa, David; Singer, Joel; Biryabarema, Christine; Byamugisha, Josaphat K; Money, Deborah M; Ogilvie, Gina S

2015-10-01

To compare two cervical cancer screening methods: community-based self-collection of high-risk human papillomavirus (HR-HPV) testing and visual inspection with acetic acid (VIA). Pilot randomised controlled trial of 500 women aged 30-65 in the community of Kisenyi, Uganda. Women randomised to self-collection-based HR-HPV testing provided a cervico-vaginal swab for HR-HPV, and results were provided by phone after laboratory testing. Women who tested HPV positive were referred for VIA at the local health unit. Women randomised to VIA underwent screening at the local health unit, where women who tested positive with VIA were provided cryotherapy at time of screening, as per local standard of care. Women were referred for colposcopy when indicated. Outcome measures were uptake of screening, HR-HPV prevalence, VIA result and treatment rates. In the HR-HPV arm, 248 of 250 (p < 0.01) women provided samples, while in the VIA arm, 121 of 250 (48.4%) women attended screening. Among the 73 of 248 HR-HPV-positive women, 45.2% (N = 33) attended VIA screening for follow-up, 21.2% (N = 7) of whom screened positive; five received treatment and two were missing clinical follow-up records. Of the 121 women in the VIA arm who attended screening, 13.2% (N = 16) screened positive; seven received cryotherapy, three refused treatment, five were referred to colposcopy; and one woman had suspected cervical cancer and received treatment after confirmatory testing. This pilot study demonstrated trial feasibility and willingness of the women to participate and be randomised successfully into the two arms. Self-collection-based cervical cancer screening had a higher uptake than VIA. © 2015 John Wiley & Sons Ltd.

The case for an internal dynamics model versus equilibrium point control in human movement.

PubMed

Hinder, Mark R; Milner, Theodore E

2003-06-15

The equilibrium point hypothesis (EPH) was conceived as a means whereby the central nervous system could control limb movements by a relatively simple shift in equilibrium position without the need to explicitly compensate for task dynamics. Many recent studies have questioned this view with results that suggest the formation of an internal dynamics model of the specific task. However, supporters of the EPH have argued that these results are not incompatible with the EPH and that there is no reason to abandon it. In this study, we have tested one of the fundamental predictions of the EPH, namely, equifinality. Subjects learned to perform goal-directed wrist flexion movements while a motor provided assistance in proportion to the instantaneous velocity. It was found that the subjects stopped short of the target on the trials where the magnitude of the assistance was randomly decreased, compared to the preceding control trials (P = 0.003), i.e. equifinality was not achieved. This is contrary to the EPH, which predicts that final position should not be affected by external loads that depend purely on velocity. However, such effects are entirely consistent with predictions based on the formation of an internal dynamics model.

A randomized control trial of interventions in school-aged children with auditory processing disorders.

PubMed

Sharma, Mridula; Purdy, Suzanne C; Kelly, Andrea S

2012-07-01

The primary purpose of the study was to compare intervention approaches for children with auditory processing disorder (APD): bottom-up training including activities focused on auditory perception, discrimination, and phonological awareness, and top-down training including a range of language activities. Another purpose was to determine the benefits of personal FM systems. The study is a randomized control trial where participants were allocated to groups receiving one of the two interventions, with and without personal FM, or to the no intervention group. The six-week intervention included weekly one-hour sessions with a therapist in the clinic, plus 1-2 hours per week of parent-directed homework. 55 children (7 to 13 years) with APD participated in the study. Intervention outcomes included reading, language, and auditory processing. Positive outcomes were observed for both training approaches and personal FM systems on several measures. Pre-intervention nonverbal IQ, age, and severity of APD did not influence outcomes. Performance of control group participants did not change when retested after the intervention period. Both intervention approaches were beneficial and there were additional benefits with the use of personal FM. Positive results were not limited to the areas specifically targeted by the interventions.

Medical-grade honey does not reduce skin colonization at central venous catheter-insertion sites of critically ill patients: a randomized controlled trial

PubMed Central

2012-01-01

Introduction Catheter-related bloodstream infections (CRBSIs) associated with short-term central venous catheters (CVCs) in intensive care unit (ICU) patients are a major clinical problem. Bacterial colonization of the skin at the CVC insertion site is an important etiologic factor for CRBSI. The aim of this study was to assess the efficacy of medical-grade honey in reducing bacterial skin colonization at insertion sites. Methods A prospective, single-center, open-label randomized controlled trial was performed at the ICU of a university hospital in The Netherlands to assess the efficacy of medical-grade honey to reduce skin colonization of insertion sites. Medical-grade honey was applied in addition to standard CVC-site dressing and disinfection with 0.5% chlorhexidine in 70% alcohol. Skin colonization was assessed on a daily basis before CVC-site disinfection. The primary end point was colonization of insertion sites with >100 colony-forming units at the last sampling before removal of the CVC or transfer of the patient from the ICU. Secondary end points were quantitative levels of colonization of the insertion sites and colonization of insertion sites stratified for CVC location. Results Colonization of insertion sites was not affected by the use of medical-grade honey, as 44 (34%) of 129 and 36 (34%) of 106 patients in the honey and standard care groups, respectively, had a positive skin culture (P = 0.98). Median levels of skin colonization at the last sampling were 1 (0 to 2.84) and 1 (0 to 2.70) log colony-forming units (CFUs)/swab for the honey and control groups, respectively (P = 0.94). Gender, days of CVC placement, CVC location, and CVC type were predictive for a positive skin culture. Correction for these variables did not change the effect of honey on skin-culture positivity. Conclusions Medical-grade honey does not affect colonization of the skin at CVC insertion sites in ICU patients when applied in addition to standard disinfection with 0.5% chlorhexidine in 70% alcohol. Trial registration Netherlands Trial Registry, NTR1652. PMID:23111148

Non-surgical interventions for convergence insufficiency

PubMed Central

Scheiman, Mitchell; Gwiazda, Jane; Li, Tianjing

2014-01-01

Background Convergence insufficiency is a common eye muscle co-ordination problem in which the eyes have a strong tendency to drift outward (exophoria) when reading or doing close work. Symptoms may include eye strain, headaches, double vision, print moving on the page, frequent loss of place when reading, inability to concentrate, and short attention span. Objectives To systematically assess and synthesize evidence from randomized controlled trials (RCTs) on the effectiveness of non-surgical interventions for convergence insufficiency. Search strategy We searched The Cochrane Library, MEDLINE, EMBASE, Science Citation Index, the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov) on 7 October 2010. We manually searched reference lists and optometric journals. Selection criteria We included RCTs examining any form of non-surgical intervention against placebo, no treatment, sham treatment, or each other. Data collection and analysis Two authors independently assessed eligibility, risk of bias, and extracted data. We performed meta-analyses when appropriate. Main results We included six trials (three in children, three in adults) with a total of 475 participants. We graded four trials at low risk of bias. Evidence from one trial (graded at low risk of bias) suggests that base-in prism reading glasses was no more effective than placebo reading glasses in improving clinical signs or symptoms in children. Evidence from one trial (graded at high risk of bias) suggests that base-in prism glasses using a progressive addition lens design was more effective than progressive addition lens alone in decreasing symptoms in adults. At three weeks of therapy, the mean difference in Convergence Insufficiency Symptoms Survey (CISS) score was −10.24 points (95% confidence interval (CI) −15.45 to −5.03). Evidence from two trials (graded at low risk of bias) suggests that outpatient (or office-based as used in the US) vision therapy/orthoptics was more effective than home-based convergence exercises (or pencil push-ups as used in the US) in children. At 12 weeks of therapy, the mean difference in change in near point of convergence, positive fusional vergence, and CISS score from baseline was 3.99 cm (95% CI 2.11 to 5.86), 13.13 diopters (95% CI 9.91 to 16.35), and 9.86 points (95% CI 6.70 to 13.02), respectively. In a young adult population, evidence from one trial (graded at low risk of bias) suggests outpatient vision therapy/orthoptics was more effective than home-based convergence exercises in improving positive fusional vergence at near (7.7 diopters, 95% CI 0.82 to 14.58), but not the other outcomes. Evidence from one trial (graded at low risk of bias) comparing four interventions, also suggests that outpatient vision therapy/orthoptics was more effective than home-based computer vision therapy/orthoptics in children. At 12 weeks, the mean difference in change in near point of convergence, positive fusional vergence, and CISS score from baseline was 2.90 cm (95% CI 0.96 to 4.84), 7.70 diopters (95% CI 3.94 to 11.46), and 8.80 points (95% CI 5.26 to 12.34), respectively. Evidence was less consistent for other pair-wise comparisons. Authors’ conclusions Current research suggests that outpatient vision therapy/orthoptics is more effective than home-based convergence exercises or home-based computer vision therapy/orthoptics for children. In adult population, evidence of the effectiveness of various non-surgical interventions is less consistent. PMID:21412896

Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections.

PubMed

Fajardo-Bernal, Luisa; Aponte-Gonzalez, Johanna; Vigil, Patrick; Angel-Müller, Edith; Rincon, Carlos; Gaitán, Hernando G; Low, Nicola

2015-09-29

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most frequent causes of bacterial sexually transmitted infections (STIs). Management strategies that reduce losses in the clinical pathway from infection to cure might improve STI control and reduce complications resulting from lack of, or inadequate, treatment. To assess the effectiveness and safety of home-based specimen collection as part of the management strategy for Chlamydia trachomatis and Neisseria gonorrhoeae infections compared with clinic-based specimen collection in sexually-active people. We searched the Cochrane Sexually Transmitted Infections Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS on 27 May 2015, together with the World Health Organization International Clinical Trials Registry (ICTRP) and ClinicalTrials.gov. We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies. Randomized controlled trials (RCTs) of home-based compared with clinic-based specimen collection in the management of C. trachomatis and N. gonorrhoeae infections. Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We contacted study authors for additional information. We resolved any disagreements through consensus. We used standard methodological procedures recommended by Cochrane. The primary outcome was index case management, defined as the number of participants tested, diagnosed and treated, if test positive. Ten trials involving 10,479 participants were included. There was inconclusive evidence of an effect on the proportion of participants with index case management (defined as individuals tested, diagnosed and treated for CT or NG, or both) in the group with home-based (45/778, 5.8%) compared with clinic-based (51/788, 6.5%) specimen collection (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.29; 3 trials, I² = 0%, 1566 participants, moderate quality). Harms of home-based specimen collection were not evaluated in any trial. All 10 trials compared the proportions of individuals tested. The results for the proportion of participants completing testing had high heterogeneity (I² = 100%) and were not pooled. We could not combine data from individual studies looking at the number of participants tested because the proportions varied widely across the studies, ranging from 30% to 96% in home group and 6% to 97% in clinic group (low-quality evidence). The number of participants with positive test was lower in the home-based specimen collection group (240/2074, 11.6%) compared with the clinic-based group (179/967, 18.5%) (RR 0.72, 95% CI 0.61 to 0.86; 9 trials, I² = 0%, 3041 participants, moderate quality). Home-based specimen collection could result in similar levels of index case management for CT or NG infection when compared with clinic-based specimen collection. Increases in the proportion of individuals tested as a result of home-based, compared with clinic-based, specimen collection are offset by a lower proportion of positive results. The harms of home-based specimen collection compared with clinic-based specimen collection have not been evaluated. Future RCTs to assess the effectiveness of home-based specimen collection should be designed to measure biological outcomes of STI case management, such as proportion of participants with negative tests for the relevant STI at follow-up.

Survival in HIV-positive transplant recipients compared with transplant candidates and with HIV-negative controls

PubMed Central

Roland, Michelle E.; Barin, Burc; Huprikar, Shirish; Murphy, Barbara; Hanto, Douglas W.; Blumberg, Emily; Olthoff, Kim; Simon, David; Hardy, William D.; Beatty, George; Stock, Peter G.

2016-01-01

Objectives To evaluate the impact of liver and kidney transplantation on survival in HIV-positive transplant candidates and compare outcomes between HIV-positive and negative recipients. Design Observational cohort of HIV-positive transplant candidates and recipients and secondary analysis comparing study recipients to HIV-negative national registry controls. Methods We fit proportional hazards models to assess transplantation impact on mortality among recipients and candidates. We compared time to graft failure and death with HIV-negative controls in unmatched, demographic-matched, and risk-adjusted models. Results There were 17 (11.3%) and 46 (36.8%) deaths among kidney and liver recipients during a median follow-up of 4.0 and 3.5 years, respectively. Transplantation was associated with survival benefit for HIV-infected liver recipients with model for end-stage liver disease (MELD) greater than or equal 15 [hazard ratio (HR) 0.1; 95% confidence interval (CI) 0.05, 0.01; P <0.0001], but not for MELD less than 15 (HR 0.7; 95% CI 0.3, 1.8; P =0.43) or for kidney recipients (HR 0.6; 95% CI 0.3, 1.4; P =0.23). In HIV-positive kidney recipients, unmatched and risk-matched analyses indicated a marginally significant HR for graft loss [1.3 (P =0.07) and HR 1.4 (P =0.052)]; no significant increase in risk of death was observed. All models demonstrated a higher relative hazard of graft loss or death in HIV-positive liver recipients; the absolute difference in the proportion of deaths was 6.7% in the risk-matched analysis. Conclusion Kidney transplantation should be standard of care for well managed HIV-positive patients. Liver transplant in candidates with high MELD confers survival benefit; transplant is a viable option in selected candidates. The increased mortality risk compared with HIV-negative recipients was modest. Trial Registration ClinicalTrials.Gov; NCT00074386; http://clinicaltrials.gov/. PMID:26765937

Improving glycaemic control self-efficacy and glycaemic control behaviour in Chinese patients with type 2 diabetes mellitus: randomised controlled trial.

PubMed

Shi, Qifang; Ostwald, Sharon K; Wang, Shaopeng

2010-02-01

To examine the effect of a hospital-based clinic intervention on glycaemic control self-efficacy and glycaemic control behaviour of Chinese patients with type 2 diabetes mellitus (DM). Self-efficacy expectations are related to self-management of diabetes and, in conjunction with environmental support, are better predictors of behaviour than are knowledge and skills. Enhancing self-efficacy in patients with DM has been shown to have a positive effect on behavioural change and positively influence long-term glycaemic control. A randomised controlled trial study consisting of two-group pretest-post-test. One hundred and fifty-seven patients with type 2 DM were randomly divided into two groups: (1) the experimental group (77 patients) receiving one-month hospital-based clinic intervention and (2) the control group (80 patients) receiving usual care. Data collection instruments used in this study were Diabetes Management Self-Efficacy Scale and Summary of Diabetes Self-Care Activities Measure. Outcomes were determined by changes in glycaemic control self-efficacy and glycaemic control behaviour of patients with type 2 DM. The findings revealed that the experimental group showed statistically significant improvement in glycaemic control self-efficacy and glycaemic control behaviour immediately and four months after the intervention (F = 26.888, df = 1, 155, p < 0.05 and F = 18.619, df = 1, 155, p < 0.05, respectively). One-month hospital-based clinic intervention could be useful in improving glycaemic control self-efficacy and glycaemic control behaviour. Nurses can learn and use the sources of self-efficacy to enhance patients' self-efficacy on their glycaemic control in clinical care. The health education is most important in nursing care and should be considered while organising the hospital-based clinic intervention.

Impact of vitamin D supplementation on the outcome of tuberculosis treatment: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Xia, Jingyan; Shi, Liyun; Zhao, Lifang; Xu, Feng

2014-01-01

Vitamin D supplementation is believed to be beneficial in the treatment of patients with tuberculosis (TB), however, results from clinical trials have been inconclusive. We performed a systematic literature search across MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Springer, EBSCO, ProQuest, HighWire Press, and Web of Science, published as of December 2013. We individually inspected citations and extracted data independently. We estimated pooled risk ratios (RR) and 95% confidence intervals (CI) using random-effect models. We also assessed risk of bias using the Jadad scale and the quality of the evidence using GRADE. We included all randomized controlled trials comparing vitamin D with or without standard TB therapy or placebo. A total of five studies were analyzed in our meta analysis covering 841 newly-diagnosed TB cases. Patients receiving vitamin D supplementation had a 39% reduced risk of sputum smear or culture positive after six weeks of anti-TB treatment than those in the control group, although this is not statistically significant (pooled RR 0.61, 95% CI 0.24 to 1.56, P = 0.30). Apart from an increased serum vitamin D level in the supplement group after eight weeks of treatment there was no evidence of any additional adverse effects related to vitamin D. The meta analysis results indicate that vitamin D supplementation does not seem to have any beneficial effect in the treatment of TB. Future rigorous randomized controlled trials are needed to explore whether the supplementation of vitamin D could shorten treatment duration and to confirm whether the polymorphisms of vitamin D receptor have any potentially beneficial effect.

Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial.

PubMed

Derks, Marloes G M; Blok, Erik J; Seynaeve, Caroline; Nortier, Johan W R; Kranenbarg, Elma Meershoek-Klein; Liefers, Gerrit-Jan; Putter, Hein; Kroep, Judith R; Rea, Daniel; Hasenburg, Annette; Markopoulos, Christos; Paridaens, Robert; Smeets, Jan B E; Dirix, Luc Y; van de Velde, Cornelis J H

2017-09-01

After 5 years of median follow-up, the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial reported no difference in disease-free survival between exemestane monotherapy and a sequential scheme of tamoxifen followed by exemestane in postmenopausal patients with early-stage, hormone receptor-positive breast cancer. As recurrence risk in hormone receptor-positive breast cancer remains linear beyond 5 years after diagnosis, we analysed long-term follow-up outcomes of this trial. The TEAM trial, a multicentre, open-label, randomised, controlled, phase 3 trial, included postmenopausal patients with early-stage hormone receptor-positive breast cancer from nine countries. Patients were randomly allocated (1:1) by a computer-generated random permuted block method (block sizes 4-8) to either 5 years of oral exemestane monotherapy (25 mg once a day) or a sequential scheme of oral tamoxifen (20 mg once a day) followed by exemestane for a total duration of 5 years. After the publication of the IES trial, the protocol was amended (Dec 13, 2004). Patients assigned to tamoxifen were switched after 2·5-3·0 years to exemestane therapy for a total duration of 5·0 years of treatment. Randomisation was done centrally in each country. Long-term follow-up data for disease recurrence and survival was collected in six participating countries and analysed by intention to treat. The primary endpoint was disease-free survival at 10 years of follow-up. The trial is registered with ClinicalTrials.gov, numbers NCT00279448 and NCT00032136; with Netherlands Trial Register, number NTR 267; and the Ethics Commission Trial, number 27/2001. 6120 patients of the original 9776 patients in the TEAM trial were included in the current intention-to-treat analysis. Median follow-up was 9·8 years (IQR 8·0-10·3). During follow-up, 921 (30%) of 3075 patients in the exemestane group and 929 (31%) of 3045 patients in the sequential group had a disease-free survival event. Disease-free survival at 10 years was 67% (95% CI 65-69) for the exemestane group and 67% (65-69) for the sequential group (hazard ratio 0·96, 0·88-1·05; p=0·39). The long-term findings of the TEAM trial confirm that both exemestane alone and sequential treatment with tamoxifen followed by exemestane are reasonable options as adjuvant endocrine therapy in postmenopausal patients with hormone receptor-positive early breast cancer. These results suggest that the opportunity to individualise adjuvant endocrine strategy accordingly, based on patient preferences, comorbidities, and tolerability might be possible. Pfizer, Dutch Cancer Foundation. Copyright © 2017 Elsevier Ltd. All rights reserved.