WorldWideScience

Sample records for outcomes scout trial

  1. Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.

    Science.gov (United States)

    Caterson, I D; Finer, N; Coutinho, W; Van Gaal, L F; Maggioni, A P; Torp-Pedersen, C; Sharma, A M; Legler, U F; Shepherd, G M; Rode, R A; Perdok, R J; Renz, C L; James, W P T

    2012-06-01

    The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Overweight/obese subjects (N = 10 744), ≥55 years with cardiovascular disease and/or type 2 diabetes mellitus, received sibutramine plus weight management during a 6-week Lead-in Period before randomization to continue sibutramine (N = 4906) or to receive placebo (N = 4898). The primary endpoint was the time from randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild cardiovascular disease. Modest weight loss over short-term (6 weeks) and longer-term (6-12 months) periods is associated with reduction in subsequent cardiovascular mortality for the following 4-5 years even in those with pre-existing cardiovascular disease. While the sibutramine group experienced more primary outcome events than the placebo group, greater weight loss reduced overall risk of these occurring in both groups. © 2011 Blackwell Publishing Ltd.

  2. Weight and blood pressure response to weight management and sibutramine in diabetic and non-diabetic high-risk patients: an analysis from the 6-week lead-in period of the sibutramine cardiovascular outcomes (SCOUT) trial

    DEFF Research Database (Denmark)

    Van Gaal, L F; Caterson, I D; Coutinho, W

    2010-01-01

    To assess treatment responses to sibutramine and weight management in diabetic patients during the lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.......To assess treatment responses to sibutramine and weight management in diabetic patients during the lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) trial....

  3. Blood pressure changes associated with sibutramine and weight management - an analysis from the 6-week lead-in period of the sibutramine cardiovascular outcomes trial (SCOUT)

    DEFF Research Database (Denmark)

    Sharma, A M; Caterson, I D; Coutinho, W

    2009-01-01

    OBJECTIVE: To explore vital sign changes among patient subgroups during the 6-week lead-in period of the sibutramine cardiovascular outcomes (SCOUT) trial. METHODS: SCOUT is an ongoing, double-blind, randomized, placebo-controlled outcome trial in overweight/obese patients at high risk of a cardi......OBJECTIVE: To explore vital sign changes among patient subgroups during the 6-week lead-in period of the sibutramine cardiovascular outcomes (SCOUT) trial. METHODS: SCOUT is an ongoing, double-blind, randomized, placebo-controlled outcome trial in overweight/obese patients at high risk...... of a cardiovascular event. During the 6-week lead-in period, 10,742 patients received sibutramine and weight management. Vital sign changes were assessed post hoc by initial blood pressure (mmHg) categorized as normal (or=140/>or=90); weight change...... categories (weight gain/no weight change, >0 to 2.5% weight loss, >2.5 to 5% weight loss and >5% weight loss) and current antihypertensive medication class use (none, one, or two or more). To assess the impact of sibutramine on blood pressure and pulse rate, only patients (N = 10,025) who reported no change...

  4. A group-randomized controlled trial for health promotion in Girl Scouts: Healthier Troops in a SNAP (Scouting Nutrition & Activity Program

    Directory of Open Access Journals (Sweden)

    Behrens Timothy K

    2010-02-01

    Girl Scout troop meetings appears feasible on a broader scale. Additional work is needed to bridge health promotion from such settings to other environments if lasting individual-level behavior change and obesity prevention remain targeted outcomes. Trial registration number: NCT00949637

  5. Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial

    DEFF Research Database (Denmark)

    Maggioni, A.P.; Caterson, I.; Coutinho, W.

    2008-01-01

    Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment...... of tolerability. A total of 10,742 patients received sibutramine and 3.1% of these discontinued due to an adverse event; issues affecting more than 10 patients were drug intolerance, headache, insomnia, nausea, dry mouth, and constipation-, tachycardia-, and hypertension-related events. Serious adverse events......, most commonly associated with the System Organ Class, Cardiac disorders, were reported by 2.7% of patients; however, the majority was not considered sibutramine-related. Adverse events relating to high blood pressure and/or pulse rate, whether reported as adverse events leading to discontinuation...

  6. Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial.

    Science.gov (United States)

    Maggioni, Aldo P; Caterson, Ian; Coutinho, Walmir; Finer, Nick; Gaal, Luc Van; Sharma, Arya M; Torp-Pedersen, Christian; Bacher, Peter; Shepherd, Gillian; Sun, Rui; James, Philip

    2008-11-01

    Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment of tolerability. A total of 10,742 patients received sibutramine and 3.1% of these discontinued due to an adverse event; issues affecting more than 10 patients were drug intolerance, headache, insomnia, nausea, dry mouth, and constipation-, tachycardia-, and hypertension-related events. Serious adverse events, most commonly associated with the System Organ Class, Cardiac disorders, were reported by 2.7% of patients; however, the majority was not considered sibutramine-related. Adverse events relating to high blood pressure and/or pulse rate, whether reported as adverse events leading to discontinuation, or serious adverse events were reported by less than 0.2% of patients. No serious or individual events leading to discontinuation occurred in more than 25 patients. There were 15 (0.1%) deaths; 10 were attributed to a cardiovascular cause. Discontinuations for adverse events were lower than anticipated. Serious adverse events generally reflected sibutramine's known pharmacology or were related to cardiac disorders already present in this high-risk population. When compared with epidemiological data, overall mortality rate was low and sibutramine was well tolerated in this mainly off-label population. No new safety issues were detected.

  7. A group-randomized controlled trial for health promotion in Girl Scouts: healthier troops in a SNAP (Scouting Nutrition & Activity Program).

    Science.gov (United States)

    Rosenkranz, Richard R; Behrens, Timothy K; Dzewaltowski, David A

    2010-02-19

    Girl Scouting may offer a viable channel for health promotion and obesity prevention programs. This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was designed to foster healthful troop meeting environments and increase obesity prevention behaviors at home. Seven Girl Scout troops were randomized to intervention (n = 3, with 34 girls) or standard-care control (n = 4, with 42 girls) conditions. Girls ranged in age from 9 to 13 years (mean 10.5 years). Intervention troop leaders were trained to implement policies promoting physical activity (PA) and healthful eating opportunities at troop meetings, and to implement a curriculum promoting obesity-prevention behaviors at home. The primary outcome variable was child body mass index (BMI) z-score. Secondary outcomes included accelerometer-assessed PA levels in troop meetings, direct observations of snack offerings, time spent in physically active meeting content, and leader encouragement of PA and healthful eating. The intervention was delivered with good fidelity, and intervention troops provided greater opportunities for healthful eating and PA (x2 = 210.8, p environments in Girl Scout troop meetings appears feasible on a broader scale. Additional work is needed to bridge health promotion from such settings to other environments if lasting individual-level behavior change and obesity prevention remain targeted outcomes. NCT00949637.

  8. Wellness-Promoting Practices Through Girl Scouts: A Pragmatic Superiority Randomized Controlled Trial With Additional Dissemination.

    Science.gov (United States)

    Cull, Brooke J; Dzewaltowski, David A; Guagliano, Justin M; Rosenkranz, Sara K; Knutson, Cassandra K; Rosenkranz, Richard R

    2018-01-01

    To evaluate the effectiveness of in-person versus online Girl Scout leader wellness training for implementation of wellness-promoting practices during troop meetings (phase I) and to assess training adoption and current practices across the council (phase II). Pragmatic superiority trial (phase 1) followed by serial cross-sectional study (phase II). Girl Scout troop meetings in Northeast Kansas. Eighteen troop leaders from 3 counties (phase 1); 113 troop leaders from 7 counties (phase II). Phase I: Troop leaders attended 2 wellness training sessions (first in groups, second individually), wherein leaders set wellness-promoting practice implementation goals, self-monitored progress, and received guidance and resources for implementation. Leaders received the intervention in person or online. Phase I: At baseline and postintervention, leaders completed a wellness-promoting practice implementation questionnaire assessing practices during troop meetings (max score = 11). Phase II: Leaders completed a survey about typical troop practices and interest in further training. Phase I: Generalized linear mixed modeling. Phase I: In-person training increased wellness-promoting practice implementation more than online training (in person = 2.1 ± 1.8; online = 0.2 ± 1.2; P = .022). Phase II: Fifty-six percent of leaders adopted the training. For 8 of 11 wellness categories, greater than 50% of leaders employed wellness-promoting practices. In-person training was superior to online training for improvements in wellness-promoting practices. Wellness training was adopted by the majority of leaders across the council.

  9. Epidemiology and Outcomes of Lisfranc Injuries Identified at the National Football League Scouting Combine.

    Science.gov (United States)

    McHale, Kevin J; Vopat, Bryan G; Beaulieu-Jones, Brendin R; Sanchez, George; Whalen, James M; McDonald, Lucas S; DiGiovanni, Christopher W; Theodore, George H; Provencher, Matthew T

    2017-07-01

    Lisfranc injuries are challenging to treat and may have a detrimental effect on athletic performance. (1) Determine the epidemiological characteristics of Lisfranc injuries at the annual National Football League (NFL) Scouting Combine, (2) define player positions at risk for these injuries, and (3) evaluate the impact that these injuries and radiographic findings have on NFL draft position and performance. Cohort study; Level of evidence, 3. All players who sustained a Lisfranc injury prior to Combine evaluation between 2009 and 2015 were evaluated. The epidemiological characteristics, player positions affected, treatment methods, and number of missed collegiate games were recorded. Radiographic outcomes were analyzed via Combine radiograph findings, while NFL performance outcomes were assessed for all Lisfranc injuries (2009-2013) compared with matched controls in the first 2 years of play. A total of 41 of 2162 (1.8%) Combine participants were identified with Lisfranc injuries, of whom 26 of 41 (63.4%) were managed operatively. Players who underwent surgery were more likely to go undrafted compared with players managed nonoperatively (38.5% vs 13.3%, operative vs nonoperative management, respectively; P = .04) and featured a worse NFL draft pick position (155.6 vs 109; P = .03). Lisfranc-injured players when compared with controls were noted to have worse outcomes in terms of NFL draft position (142 vs 111.3, Lisfranc-injured players vs controls, respectively; P = .04), NFL career length 2 years or longer (62.5% vs 69.6%; P = .23), and number of games played (16.9 vs 23.3; P = .001) and started (6.8 vs 10.5; P = .08) within the first 2 years of their NFL career. Radiographs demonstrated that 17 of 41 (41.5%) athletes had residual Lisfranc joint displacement greater than 2 mm compared with the contralateral foot. Lisfranc-injured athletes with greater than 2 mm residual displacement, when compared with matched controls, had worse draft position (156.9 vs 111.2 for

  10. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial

    Directory of Open Access Journals (Sweden)

    Caterson Ian D

    2009-10-01

    Full Text Available Abstract Background and aims Elevated levels of serum uric acid are associated with an increased risk of cardiovascular morbidity and mortality. The response of uric acid to weight loss therapy (lifestyle plus sibutramine in an overweight and obese cardiovascular high risk population was studied. Methods and results Data from a four week single-blind lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT study were analyzed. 2584 patients (24% had diabetes mellitus (DM only, 1748 (16% had cardiovascular disease (CVD only and 6397 (60% had both DM + CVD. Uric acid concentrations (mean ± standard deviation at screening were significantly higher among patients with CVD compared to patients without CVD (p Conclusion A four week daily intake of sibutramine and life style changes was associated with significant reductions in mean uric acid levels. Changes in renal glucose load in diabetes seem to counteract a potential uricosuric effect of sibutramine. Trial Registration The trial is registered at ClinicalTrial.gov number: NCT00234832.

  11. Improving the Tank Scout

    National Research Council Canada - National Science Library

    Burton, R. L

    2006-01-01

    .... While the tank battalions recognize the importance and value of the scout platoon, they are restricted from employing scouts to their full potential due to the platoon's inflexible structure and limited capabilities...

  12. Near Earth Asteroid Scout

    Data.gov (United States)

    National Aeronautics and Space Administration — Near-Earth Asteroid Scout, or NEA Scout, is a 6U CubeSat developed jointly between NASA’s Marshall Space Flight Center and the Jet Propulsion Laboratory. NASA...

  13. The Stochastic Scouting Problem

    NARCIS (Netherlands)

    Barros, A.I.; Evers, L.

    2012-01-01

    Efficiently scouting talented sports players is of key importance in the commercially oriented sports world. Besides being able to recognize talent, it is important to plan the scouting activities given the available time, in order to maximize the potential for scouting talented players. This

  14. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial

    DEFF Research Database (Denmark)

    Andersson, Charlotte; Weeke, Peter; Brendorp, Bente

    2009-01-01

    ABSTRACT: BACKGROUND AND AIMS: Elevated levels of serum uric acid are associated with an increased risk of cardiovascular morbidity and mortality. The response of uric acid to weight loss therapy (lifestyle plus sibutramine) in an overweight and obese cardiovascular high risk population was studied....... METHODS AND RESULTS: Data from a four week single-blind lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) study were analyzed. 2584 patients (24%) had diabetes mellitus (DM) only, 1748 (16%) had cardiovascular disease (CVD) only and 6397 (60%) had both DM + CVD. Uric acid concentrations...... significantly more in patients without DM (p sibutramine induced lower uric acid levels...

  15. Girl Scout Stars: Engaging Girl Scouts in the 2017 Total Eclipse

    Science.gov (United States)

    Harman, P. K.

    2017-12-01

    Reaching for the Stars: NASA Science for Girl Scouts (Girl Scout Stars) engages Girl Scouts in observing the 2017 eclipse. Three councils are host-sponsors of Girl Scout Total Eclipse Destinations,. Total Eclipse of the Heartland, sponsored by Girl Scouts of Southern Illinois, begins with planetarium, and science center visits in St. Louis, and transits to Carbondale for the eclipse. The Great Eclipse Adventure, sponsored by the Girl Scouts of the Missouri Heartland, features hands-on science activities led by Astronomy and Physics faculty and grad students at University of Missouri, Columbia, MO, and observing the eclipse at a camp nearby. Eyes to the Sky: A Once in a Lifetime Destination, by the Girl Scouts of South Carolina - Mountains to Midlands, visits a Challenger Center, a planetarium, and observatory, and culminates at Camp MaBak, Marietta, SC. Girl Scout Destinations are travel adventures, for individual girls ages 11 and older, that are inspiring, life-changing experiences. Destinations are determined via an application and review process by Girls Scouts of the USA. Girl Scout Stars also developed an Eclipse Activity Guide and kit box of materials, distributed the materials to 91 Girl Scout Councils, and delivered webinar training to councils. The eclipse materials enrich the girls' summer camp experiences with activities that promote understanding the Sun-Earth-Moon relationship, the solar system and safe eclipse viewing; and that feature science practices. Examples of the reach of the kit boxes are Girl Scouts of Montana and Wyoming Total Eclipse Event in Casper, WY, and the Girl Scouts of Northern California summer camps featuring the activities. In Girl Scouting, girls discover their skills, talents and what they care about; connect with other Girl Scouts and people in their community; and take action to change the world. This is called the Girl Scout Leadership Experience. With girl-led, hands on activities where girls can team up and work together

  16. Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period

    DEFF Research Database (Denmark)

    Caterson, Ian; Coutinho, Walmir; Finer, Nick

    2010-01-01

    The Sibutramine Cardiovascular Outcomes (SCOUT) trial protocol defines a patient population predominantly outside current European Union label criteria. This article explores responses to sibutramine during the 6-week, single-blind, lead-in period between patients who conformed to the label...... requirements ("conformers") and those who did not ("nonconformers"). SCOUT is an ongoing, randomized, double-blind, placebo-controlled outcome trial in overweight/obese patients at high risk of a cardiovascular event. In total, 10,742 patients received sibutramine and weight management during the lead...... with sibutramine confirms its good tolerability and efficacy in patients who meet current label criteria. Preliminary data from high-risk patients for whom sibutramine is currently contraindicated suggest a low discontinuation rate and few serious adverse events but confirmation from the SCOUT outcome data...

  17. National Boy Scout Jamboree

    Science.gov (United States)

    1989-01-01

    This video looks at a NASA sponsored exhibit at the National Boy Scout Jamboree in Fredricksburg, VA. Boy Scouts are shown interacting with NASA researchers and astronauts and touring mockups of Space Station Freedom and Apollo 11. NASA's program to encourage the researchers of tomorrow is detailed.

  18. Data Scouting in CMS

    CERN Document Server

    Anderson, Dustin James

    2016-01-01

    In 2011, the CMS collaboration introduced Data Scouting as a way to produce physics results with events that cannot be stored on disk, due to resource limits in the data acquisition and offline infrastructure. The viability of this technique was demonstrated in 2012, when 18 fb$^{-1}$ of collision data at $\\sqrt{s}$ = 8 TeV were collected. The technique is now a standard ingredient of CMS and ATLAS data-taking strategy. In this talk, we present the status of data scouting in CMS and the improvements introduced in 2015 and 2016, which promoted data scouting to a full-fledged, flexible discovery tool for the LHC Run II.

  19. Improving the Tank Scout

    National Research Council Canada - National Science Library

    Burton, R. L

    2006-01-01

    Within the Marine Corps' tank battalions is a unique asset that is often improperly employed and not well known within the other components of the Marine Air Ground Task Force (MAGTF): the scout platoon...

  20. US Cub Scouts visit CERN

    CERN Multimedia

    2001-01-01

    A group of young American Cub Scouts from Den 10, Pack 130 (based in Geneva) at the Microcosm last Saturday. On their trip to CERN, which included the first Visits Service tour of the ATLAS construction site, the scouts were able to satisfy most of the requirements for the Cub Scout engineering badge. From left to right: Edouard Vincent, Ariel Litke, Alexander Richter, Antoine Vidal de Saint Phalle, Jason Iredale and Daniel Reghelini.

  1. Girl Scout Camps and Badges: Engaging Girls in NASA Science

    Science.gov (United States)

    Harman, P. K.; DeVore, E. K.

    2017-12-01

    Reaching for the Stars: NASA Science for Girl Scouts (Girl Scout Stars) disseminates NASA STEM education-related resources, fosters interaction between Girl Scouts and NASA Subject Matter Experts (SMEs), and engages Girl Scouts in NASA science and programs through space science badges and summer camps. A space science badge is in development for each of the six levels of Girl Scouts: Daisies, Grades K - 1; Brownies, Grades 2 -3; Juniors, Grades 4 -5; Cadettes, Grades 6 -8; Seniors, Grades 9 -10: and Ambassadors, Grades 11 -12. Daisy badge will be accomplished by following three steps with two choices each. Brownie to Ambassador badges will be awarded by completing five steps with three choices for each. The badges are interwoven with science activities, role models (SMEs), and steps that lead girls to explore NASA missions. External evaluators monitor three rounds of field-testing and deliver formative assessment reports. Badges will be released in Fall of 2018 and 2019. Girl Scout Stars supports two unique camp experiences. The University of Arizona holds an Astronomy Destination, a travel and immersion adventure for individual girls ages 13 and older, which offers dark skies and science exploration using telescopes, and interacting with SMEs. Girls lean about motion of celestial objects and become astronomers. Councils send teams of two girls, a council representative and an amateur astronomer to Astronomy Camp at Goddard Space Flight Center. The teams were immersed in science content and activities, and a star party; and began to plan their new Girl Scout Astronomy Clubs. The girls will lead the clubs, aided by the council and amateur astronomer. Camps are evaluated by the Girl Scouts Research Institute. In Girl Scouting, girls discover their skills, talents and what they care about; connect with other Girl Scouts and people in their community; and take action to change the world. This is called the Girl Scout Leadership Experience. With girl-led, hands on

  2. Solids Accumulation Scouting Studies

    Energy Technology Data Exchange (ETDEWEB)

    Duignan, M. R.; Steeper, T. J.; Steimke, J. L.

    2012-09-26

    The objective of Solids Accumulation activities was to perform scaled testing to understand the behavior of remaining solids in a Double Shell Tank (DST), specifically AW-105, at Hanford during multiple fill, mix, and transfer operations. It is important to know if fissionable materials can concentrate when waste is transferred from staging tanks prior to feeding waste treatment plants. Specifically, there is a concern that large, dense particles containing plutonium could accumulate in poorly mixed regions of a blend tank heel for tanks that employ mixing jet pumps. At the request of the DOE Hanford Tank Operations Contractor, Washington River Protection Solutions, the Engineering Development Laboratory of the Savannah River National Laboratory performed a scouting study in a 1/22-scale model of a waste staging tank to investigate this concern and to develop measurement techniques that could be applied in a more extensive study at a larger scale. Simulated waste tank solids: Gibbsite, Zirconia, Sand, and Stainless Steel, with stainless steel particles representing the heavier particles, e.g., plutonium, and supernatant were charged to the test tank and rotating liquid jets were used to mix most of the solids while the simulant was pumped out. Subsequently, the volume and shape of the mounds of residual solids and the spatial concentration profiles for the surrogate for heavier particles were measured. Several techniques were developed and equipment designed to accomplish the measurements needed and they included: 1. Magnetic particle separator to remove simulant stainless steel solids. A device was designed and built to capture these solids, which represent the heavier solids during a waste transfer from a staging tank. 2. Photographic equipment to determine the volume of the solids mounds. The mounds were photographed as they were exposed at different tank waste levels to develop a composite of topographical areas. 3. Laser rangefinders to determine the volume of

  3. Scouts in Contact: Tactical Vignettes for Cavalry Leaders

    Science.gov (United States)

    2016-12-01

    Decision - Making Processes Analytical Decision Making . The classical model of decision making is a rational and systematic process of analysis based on a...senior scout are the real measures of effectiveness. Commanders should allow and reward trial and error. If a leader makes a decision that causes...professional certification from the squadron commander on their ability to make competent and fast decisions , grounded in thorough understanding of the

  4. Infertility trial outcomes: healthy moms and babies.

    Science.gov (United States)

    Silver, Robert

    2014-05-01

    Traditionally, the primary outcome of infertility trials has been a positive pregnancy test or a clinically recognized pregnancy. However, parents desire a healthy baby that grows up to be a healthy adult, rather than a positive pregnancy test. Too often results of infertility trials are lacking in crucial obstetric details. This is problematic because treatments for infertility have the capacity to increase the risk for a variety of adverse obstetric outcomes. This review will outline important obstetric variables that should be included when reporting infertility research. The rationale for including these data, precise definitions of the variables, and cost-effective strategies for obtaining these obstetric details will be highlighted. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  5. Reaching for the Stars: NASA Science for Girl Scouts (Girl Scout Stars)

    Science.gov (United States)

    DeVore, Edna; Harman, Pamela; Girl Scouts of the USA; Girl Scouts of Northern California; University of Arizona; Astronomical Society of the Pacific; Aires Scientific

    2017-01-01

    Girl Scout Stars aims to enhance STEM experiences for Girl Scouts in grades K-12. New space science badges are being created for every Girl Scout level. Using best practices, we engage girls and volunteers with the fundamental STEM concepts that underpin our human quest to explore the universe. Through early and sustained exposure to the people and assets of NASA and the excitement of NASA’s Mission, they explore STEM content, discoveries, and careers. Today’s tech savvy Girl Scout volunteers prefer just-in-time materials and asynchronous learning. The Volunteer Tool Kit taps into the wealth of NASA's online materials for the new space science badges. Training volunteers supports troop activities for the younger girls. For older girls, we enhance Girl Scout summer camp activities, support in-depth experiences at Univ. of Arizona’s Astronomy Camp, and “Destination” events for the 2017 total solar eclipse. We partner with the Night Sky Network to engage amateur astronomers with Girl Scouts. Univ. of Arizona also leads Astronomy Camp for Girl Scout volunteers. Aires Scientific leads eclipse preparation and summer sessions at NASA Goddard Space Flight Center for teams of volunteers, amateur astronomers and older Girl Scouts.There are 1,900,000 Girl Scouts and 800,000 volunteers in the USA. During development, we work with the Girl Scouts of Northern California (50,000 girl members and 31,000 volunteers) and expand across the USA to 121 Girl Scout councils over five years. SETI Institute leads the space science educators and scientists at Astronomical Society of the Pacific, Univ. of Arizona, and Aires Scientific. Girl Scouts of the USA leads dissemination of Girl Scout Stars with support of Girl Scouts of Northern California. Through professional development of Girl Scout volunteers, Girl Scout Stars enhances public science literacy. Girl Scout Stars supports the NASA Science Mission Directorate Science Education Objectives and NASA’s STEM Engagement and

  6. ScoutTM, a portable MCA system

    International Nuclear Information System (INIS)

    Cheng, A.Y.; Ziemba, F.P.; Browning, J.E.; Szluk, N.

    1998-01-01

    Quantrad Sensor's hand-held multichannel analyzer (MCA), the Scout TM , has evolved considerably from the initial licensing from Pacific Northwest Laboratories (operated by Battelle Memorial Institute for the U.S. DOE). The Scout TM has grown into a flexible MCA system with alpha-, gamma-, X-ray and neutron detection capabilities with wide ranging applications. The development philosophy is discussed along with specific examples of design choices in areas such as manufacturability, upgradability, probe interchangability and software user interface. Recently introduced products include: software enhancements, additional probes, customized software and a second generation instrument, the Scout512 TM , that boasts increased capabilities. Future developments are also discussed. (author)

  7. Leadership Workshops for Adult Girl Scout Leaders

    Science.gov (United States)

    Lebofsky, Larry A.; McCarthy, Donald; DeVore, Edna; Harman, Pamela; Reaching Stars Team

    2016-10-01

    This year, the University of Arizona is conducting its first two Leadership Workshops for Girl Scout adult leaders. These workshops are being supported by a five-year NASA Collaborative Agreement, Reaching for the Stars: NASA Science for Girl Scouts (www.seti.org/GirlScoutStars), through the SETI Institute in collaboration with the University of Arizona, Girl Scouts of the USA (GSUSA), the Girl Scouts of Northern California, the Astronomical Society of the Pacific, and Aries Scientific, Inc. These workshops are an outgrowth of Astronomy Camp for Girl Scout Leaders, a 14-year "Train the Trainer" program funded by NASA through the James Webb Space Telescope's Near Infrared Camera (NIRCam) education and outreach team. We are continuing our long-term relationship with all Girl Scout Councils to engage girls and young women not only in science and math education, but also in the astronomical and technological concepts relating to NASA's scientific mission. Our training aligns with the GSUSA Journey: It's Your Planet-Love It! and introduces participants to some of the activities that are being developed by the Girl Scout Stars team for GSUSA's new space science badges for all Girl Scout levels being developed as a part of Reaching for the Stars: NASA Science for Girl Scouts.The workshops include hands-on activities in basic astronomy (night sky, stars, galaxies, optics, telescopes, etc.) as well as some more advanced concepts such as lookback time and the expansion of the Universe. Since the inception of our original Astronomy Camp in 2003, our team has grown to include nearly 280 adult leaders, staff, and volunteers from over 79 Councils in 43 states and the District of Columbia so they can, in turn, teach young women essential concepts in astronomy, the night sky environment, applied math, and engineering. Our workshops model what astronomers do by engaging participants in the process of science inquiry, while equipping adults to host astronomy-related programs with

  8. An Inaugural Girl Scout Destinations Astronomy Camp

    Science.gov (United States)

    Lebofsky, Larry A.; McCarthy, Donald W.; Wright, Joe; Wright, Rita; Mace, Mikayla; Floyd, Charmayne

    2017-10-01

    The University of Arizona (UA) conducted its first teenage Girl Scout Destinations Astronomy Camp. This program was preceded by 24 Leadership Workshops for Adult Girl Scout Leaders, initially supported by EPO funding from NIRCam for JWST. For five days in late June, 24 girls (ages 13-17 years) attended from 16 states. The Camp was led by UA astronomers and long-term educators. Representing Girl Scouts of the USA (GSUSA) were a husband/wife amateur astronomer team who are SOFIA Airborne Astronomy and NASA Solar System Ambassadors. Other leaders included a Stanford undergraduate engineering student who is a lifelong Girl Scout and Gold Award recipient and a recent UA Master’s degree science journalist. The Camp is a residential, hands-on “immersion” adventure in scientific exploration using telescopes in southern Arizona’s Catalina Mountains near Tucson. Under uniquely dark skies girls become real astronomers, operating telescopes (small and large) and associated technologies, interacting with scientists, obtaining images and quantitative data, investigating their own questions, and most importantly having fun actually doing science and building observing equipment. Girls achieve a basic understanding of celestial objects, how and why they move, and their historical significance, leading to an authentic understanding of science, research, and engineering. Girls can lead these activities back home in their own troops and councils, encouraging others to consider STEM field careers. These programs are supported by a 5-year NASA Collaborative Agreement, Reaching for the Stars: NASA Science for Girl Scouts (www.seti.org/GirlScoutStars), through the SETI Institute in collaboration with the UA, GSUSA, Girl Scouts of Northern California, the Astronomical Society of the Pacific, and Aries Scientific, Inc. The Girl Scout Destinations Astronomy Camp aligns with the GSUSA Journey: It’s Your Planet-Love It! and introduces the girls to some of the activities being

  9. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  10. Need for Outcome Scenario Analysis of Clinical Trials in Diabetes.

    Science.gov (United States)

    Garcia-Verdugo, Rosa; Erbach, Michael; Schnell, Oliver

    2017-03-01

    Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.

  11. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  12. Educational Work of the Boy Scouts. Bulletin, 1921, No. 41

    Science.gov (United States)

    Barclay, Lorne W.

    1921-01-01

    Scouting continues to enjoy the cordial endorsement of school men everywhere in the US. More and more those interested are coming to see the enormous possibilities of cooperation between the scout movement and the schools. Many schools now give credit for scout work done outside of the schools. Many more are in hearty sympathy with the program as…

  13. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  14. Soil and Water Conservation Activities for Scouts.

    Science.gov (United States)

    Soil Conservation Service (USDA), Washington, DC.

    The purpose of the learning activities outlined in this booklet is to help Scouts understand some conservation principles which hopefully will lead to the development of an attitude of concern for the environment and a commitment to help with the task of using and managing soil, water, and other natural resources for long range needs as well as…

  15. Scouts behave as streakers in honeybee swarms

    Science.gov (United States)

    Greggers, Uwe; Schöning, Caspar; Degen, Jacqueline; Menzel, Randolf

    2013-08-01

    Harmonic radar tracking was used to record the flights of scout bees during takeoff and initial flight path of two honeybee swarms. One swarm remained intact and performed a full flight to a destination beyond the range of the harmonic radar, while a second swarm disintegrated within the range of the radar and most of the bees returned to the queen. The initial stretch of the full flight is characterized by accelerating speed, whereas the disintegrating swarm flew steadily at low speed. The two scouts in the swarm displaying full flight performed characteristic flight maneuvers. They flew at high speed when traveling in the direction of their destination and slowed down or returned over short stretches at low speed. Scouts in the disintegrating swarm did not exhibit the same kind of characteristic flight performance. Our data support the streaker bee hypothesis proposing that scout bees guide the swarm by traveling at high speed in the direction of the new nest site for short stretches of flight and slowing down when reversing flight direction.

  16. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  17. Scout Rover Applications for Forward Acquisition of Soil and Terrain Data

    Science.gov (United States)

    Sonsalla, R.; Ahmed, M.; Fritsche, M.; Akpo, J.; Voegele, T.

    2014-04-01

    As opposed to the present mars exploration missions future mission concepts ask for a fast and safe traverse through vast and varied expanses of terrain. As seen during the Mars Exploration Rover (MER) mission the rovers suffered a lack of detailed soil and terrain information which caused Spirit to get permanently stuck in soft soil. The goal of the FASTER1 EU-FP7 project is to improve the mission safety and the effective traverse speed for planetary rover exploration by determining the traversability of the terrain and lowering the risk to enter hazardous areas. To achieve these goals, a scout rover will be used for soil and terrain sensing ahead of the main rover. This paper describes a highly mobile, and versatile micro scout rover that is used for soil and terrain sensing and is able to co-operate with a primary rover as part of the FASTER approach. The general reference mission idea and concept is addressed within this paper along with top-level requirements derived from the proposed ESA/NASA Mars Sample Return mission (MSR) [4]. Following the mission concept and requirements [3], a concept study for scout rover design and operations has been performed [5]. Based on this study the baseline for the Coyote II rover was designed and built as shown in Figure 1. Coyote II is equipped with a novel locomotion concept, providing high all terrain mobility and allowing to perform side-to-side steering maneuvers which reduce the soil disturbance as compared to common skid steering [6]. The rover serves as test platform for various scout rover application tests ranging from locomotion testing to dual rover operations. From the lessons learned from Coyote II and for an enhanced design, a second generation rover (namely Coyote III) as shown in Figure 2 is being built. This rover serves as scout rover platform for the envisaged FASTER proof of concept field trials. The rover design is based on the test results gained by the Coyote II trials. Coyote III is equipped with two

  18. CT scout films: Don't forget to look

    International Nuclear Information System (INIS)

    Emamian, Seyed A.; Dubovsky, Elizabeth C.; Vezina, L. Gilbert; Bulas, Dorothy I.; Carter, William

    2003-01-01

    A lateral scout view of the head is always obtained when performing head computed tomography (CT). It is common knowledge that viewing the lateral scout view may provide additional information. For a variety of reasons, however, a careful review may not be performed routinely. To illustrate the value of the lateral scout view, we present a series of representative cases. Six patients with clinically relevant findings on the scout view. Most of the ancillary findings were in the upper cervical spine/neck, which is typically included on the lateral scout view. Careful evaluation of the scout view of the head CT, including the skull and neck, may yield valuable information, which may not be visualized on the axial CT images. (orig.)

  19. CT scout films: Don't forget to look.

    Energy Technology Data Exchange (ETDEWEB)

    Emamian, Seyed A.; Dubovsky, Elizabeth C.; Vezina, L. Gilbert; Bulas, Dorothy I. [Department of Diagnostic Imaging and Radiology, Children' s National Medical Center, George Washington University, 111 Michigan Avenue NW, DC 20010, Washington (United States); Carter, William [Department of Radiology, Bethesda Naval Medical Center, Rockville, MD (United States)

    2003-08-01

    A lateral scout view of the head is always obtained when performing head computed tomography (CT). It is common knowledge that viewing the lateral scout view may provide additional information. For a variety of reasons, however, a careful review may not be performed routinely. To illustrate the value of the lateral scout view, we present a series of representative cases. Six patients with clinically relevant findings on the scout view. Most of the ancillary findings were in the upper cervical spine/neck, which is typically included on the lateral scout view. Careful evaluation of the scout view of the head CT, including the skull and neck, may yield valuable information, which may not be visualized on the axial CT images. (orig.)

  20. Scout or Cavalry? Optimal Discovery Strategies for GRBs

    International Nuclear Information System (INIS)

    Nemiroff, Robert J.

    2004-01-01

    Many present and past gamma-ray burst (GRB) detectors try to be not only a 'scout', discovering new GRBs, but also the 'cavalry', simultaneously optimizing on-board science return. Recently, however, most GRB science return has moved out from the gamma-ray energy bands where discovery usually occurs. Therefore a future gamma-ray instrument that is only a scout might best optimize future GRB science. Such a scout would specialize solely in the initial discovery of GRBs, determining only those properties that would allow an unambiguous handoff to waiting cavalry instruments. Preliminary general principles of scout design and cadence are discussed. Scouts could implement observing algorithms optimized for finding GRBs with specific attributes of duration, location, or energy. Scout sky-scanning algorithms utilizing a return cadence near to desired durations of short GRBs are suggested as a method of discovering GRBs in the unexplored short duration part of the GRB duration distribution

  1. Relationship between HbA1c levels and risk of cardiovascular adverse outcomes and all-cause mortality in overweight and obese cardiovascular high-risk women and men with type 2 diabetes

    DEFF Research Database (Denmark)

    Andersson, C; van Gaal, L; Caterson, I D

    2012-01-01

    The optimal HbA(1c) concentration for prevention of macrovascular complications and deaths in obese cardiovascular high-risk patients with type 2 diabetes remains to be established and was therefore studied in this post hoc analysis of the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, which ...

  2. Outcome Measures for Clinical Trials in Down Syndrome.

    Science.gov (United States)

    Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

    2017-05-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

  3. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

    Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H

    2012-01-01

    Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we...

  4. Effects of Age on Outcome in the SENTIS Trial : Better Outcomes in Elderly Patients

    NARCIS (Netherlands)

    Leker, Ronen R.; Molina, Carlos; Cockroft, Kevin; Liebeskind, David S.; Concha, Mauricio; Shuaib, Ashfaq; De Deyn, Peter Paul; Burgin, W. Scott; Gupta, Rishi; Dillon, William; Diener, Hans-Christoph

    2012-01-01

    Background: Increasing age is associated with poor outcome after stroke. The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial explored the augmentation of collateral circulation to the ischemic penumbra as a novel approach to stroke treatment. The aim of this post hoc

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

    Directory of Open Access Journals (Sweden)

    Marleine Azar

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

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

    Science.gov (United States)

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

    2015-01-01

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

  7. Use of outcome measures in pulmonary hypertension clinical trials.

    Science.gov (United States)

    Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

    2015-09-01

    To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or stable use of imaging and invasive measures. In contrast, imaging and invasive measures are commonly used in contemporary clinical practice. Further research is needed to validate and standardize currently used measures. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Imaging outcomes for trials of remyelination in multiple sclerosis.

    Science.gov (United States)

    Mallik, Shahrukh; Samson, Rebecca S; Wheeler-Kingshott, Claudia A M; Miller, David H

    2014-12-01

    Trials of potential neuroreparative agents are becoming more important in the spectrum of multiple sclerosis research. Appropriate imaging outcomes are required that are feasible from a time and practicality point of view, as well as being sensitive and specific to myelin, while also being reproducible and clinically meaningful. Conventional MRI sequences have limited specificity for myelination. We evaluate the imaging modalities which are potentially more specific to myelin content in vivo, such as magnetisation transfer ratio (MTR), restricted proton fraction f (from quantitative magnetisation transfer measurements), myelin water fraction and diffusion tensor imaging (DTI) metrics, in addition to positron emission tomography (PET) imaging. Although most imaging applications to date have focused on the brain, we also consider measures with the potential to detect remyelination in the spinal cord and in the optic nerve. At present, MTR and DTI measures probably offer the most realistic and feasible outcome measures for such trials, especially in the brain. However, no one measure currently demonstrates sufficiently high sensitivity or specificity to myelin, or correlation with clinical features, and it should be useful to employ more than one outcome to maximise understanding and interpretation of findings with these sequences. PET may be less feasible for current and near-future trials, but is a promising technique because of its specificity. In the optic nerve, visual evoked potentials can indicate demyelination and should be correlated with an imaging outcome (such as optic nerve MTR), as well as clinical measures. 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.

  9. User's operating procedures. Volume 2: Scout project financial analysis program

    Science.gov (United States)

    Harris, C. G.; Haris, D. K.

    1985-01-01

    A review is presented of the user's operating procedures for the Scout Project Automatic Data system, called SPADS. SPADS is the result of the past seven years of software development on a Prime mini-computer located at the Scout Project Office, NASA Langley Research Center, Hampton, Virginia. SPADS was developed as a single entry, multiple cross-reference data management and information retrieval system for the automation of Project office tasks, including engineering, financial, managerial, and clerical support. This volume, two (2) of three (3), provides the instructions to operate the Scout Project Financial Analysis program in data retrieval and file maintenance via the user friendly menu drivers.

  10. User's operating procedures. Volume 1: Scout project information programs

    Science.gov (United States)

    Harris, C. G.; Harris, D. K.

    1985-01-01

    A review of the user's operating procedures for the Scout Project Automatic Data System, called SPADS is given. SPADS is the result of the past seven years of software development on a Prime minicomputer located at the Scout Project Office. SPADS was developed as a single entry, multiple cross reference data management and information retrieval system for the automation of Project office tasks, including engineering, financial, managerial, and clerical support. The instructions to operate the Scout Project Information programs in data retrieval and file maintenance via the user friendly menu drivers is presented.

  11. Lessons Learned from Custer’s Last Stand for Developing Acquisition Scouts

    Science.gov (United States)

    2017-03-31

    Private, Indian Scout Reynolds, Charles Alexander KIA Guide, Quartermaster Round Wooden Cloud Sioux Private, Indian Scout Running Wolf NP...Arikara Private, Indian Scout White Cloud Arikara Private, Indian Scout White Eagle Arikara Private, Indian Scout White Man Runs Him Crow...American West. Little, Brown, and Company. FM 2-22.3, (2006). Human Intelligence Collector Operations. HQ , Department of the Army, Washington, D.C

  12. Developmental Trajectories of Youth Character: A Five-Wave Longitudinal Study of Cub Scouts and Non-Scout Boys.

    Science.gov (United States)

    Wang, Jun; Ferris, Kaitlyn A; Hershberg, Rachel M; Lerner, Richard M

    2015-12-01

    Youth development programs, such as the Boy Scouts of America, aim to develop positive attributes in youth (e.g., character virtues, prosocial behaviors, and positive civic actions), which are necessary for individuals and societies to flourish. However, few developmental studies have focused on how specific positive attributes develop through participation in programs such as the Boy Scouts of America. As part of the Character and Merit Project, this article examined the developmental trajectories of character and other positive attributes, which are of focal concern of the Boy Scouts of America and the developmental literature. Data were collected from 1398 Scouts (M = 8.59 years, SD = 1.29 years, Range 6.17-11.92 years) and 325 non-Scout boys (M = 9.06 years, SD = 1.43 years, Range 6.20-11.81 years) over five waves of testing across a two-and-half-year period. Latent growth-curve analyses of self-report survey data examined the developmental trajectories of the attributes. Older youth rated themselves lower than younger participants on helpfulness, reverence, thriftiness, and school performance. However, all youth had moderately high self-ratings on all the attributes. Across waves, Scouts' self-ratings increased significantly for cheerfulness, helpfulness, kindness, obedience, trustworthiness, and hopeful future expectations. Non-Scout boys' self-ratings showed no significant change for any attributes except for a significant decrease in religious reverence among non-Scout boys from religious institutions. We discuss implications for positive youth development and for the role of the Boy Scouts of America programming in character development.

  13. Reporting outcomes of back pain trials: a modified Delphi study

    DEFF Research Database (Denmark)

    Froud, R.; Eldridge, S.; Kovacs, F.

    2011-01-01

    trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi......BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement. RESULTS: A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes...

  14. The Aliskiren Trial to Minimize OutcomeS in Patients with HEart failure trial (ATMOSPHERE)

    DEFF Research Database (Denmark)

    Krum, Henry; McMurray, John J V; Abraham, William T

    2015-01-01

    in ATMOSPHERE with those in the Prospective comparison of Angiotensin Receptor neprilysin inhibitors with Angiotensin converting enzyme inhibitors to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF); and (iii) compare the characteristics of patients with and without...... dysfunction, and were treated with a mineralocorticoid receptor antagonist. In ATMOSPHERE, patients with diabetes differed in numerous ways from those without. Patients with diabetes were older and had worse heart failure status but a similar left ventricular ejection fraction (mean 28%); they had a higher...... body mass index and more co-morbidity, especially hypertension and coronary heart disease. Mean estimated glomerular filtration rate was slightly lower in those with diabetes compared with those without. CONCLUSION: ATMOSPHERE will determine whether patients with HF and reduced ejection fraction...

  15. Field applications of the ScoutTM portable MCA

    International Nuclear Information System (INIS)

    Cheng, A.Y.; Ziemba, F.P.; Browning, J.E.

    1998-01-01

    The use of Quantrad Sensor's Scout TM in field type applications is described. The portability of the Scout TM enables the user to obtain more accurate information in the field versus a survey meter. Isotopic identification is possible when ancillary information is combined with built-in software libraries. Data from the Scout TM in remediation at Stanford Linear Accelerator (SLAC), NORM (Naturally Occurring Radioactive Material) measurements in California's Central Valley oil fields, medical isotope identification at nuclear pharmaceutical company and emergency response applications are presented. Additionally, custom software enabled the use of the Scout TM in identification, qualification and detection of Special Nuclear Materials (SNM) in illicit trafficking and portal monitoring applications. (author)

  16. Effects of a behaviour change intervention for Girl Scouts on child and parent energy-saving behaviours

    Science.gov (United States)

    Boudet, Hilary; Ardoin, Nicole M.; Flora, June; Armel, K. Carrie; Desai, Manisha; Robinson, Thomas N.

    2016-08-01

    Energy education programmes for children are hypothesized to have great potential to save energy. Such interventions are often assumed to impact child and family behaviours. Here, using a cluster-randomized controlled trial with 30 Girl Scout troops in Northern California, we assess the efficacy of two social cognitive theory-based interventions focused on residential and food-and-transportation energy-related behaviours of Girl Scouts and their families. We show that Girl Scouts and parents in troops randomly assigned to the residential energy intervention significantly increased their self-reported residential energy-saving behaviours immediately following the intervention and after more than seven months of follow-up, compared with controls. Girl Scouts in troops randomly assigned to the food-and-transportation energy intervention significantly increased their self-reported food-and-transportation energy-saving behaviours immediately following the intervention, compared with controls, but not at follow-up. The results demonstrate that theory-based, child-focused energy interventions have the potential to increase energy-saving behaviours among both children and their parents.

  17. Evaluating Boy Scout Geology Education, A Pilot Study

    Science.gov (United States)

    Hintz, R. S.; Thomson, B.

    2008-12-01

    This study investigated geology knowledge acquisition by Boy Scouts through use of the Boy Scout Geology Merit Handbook. In this study, boys engaged in hands-on interactive learning following the requirements set forth in the Geology Merit Badge Handbook. The purposes of this study were to determine the amount of geology content knowledge engendered in adolescent males through the use of the Geology Merit Badge Handbook published by the Boy Scouts of America; to determine if single sex, activity oriented, free-choice learning programs can be effective in promoting knowledge development in young males; and to determine if boys participating in the Scouting program believed their participation helped them succeed in school. Members of a local Boy Scout Troop between the ages of 11 and 18 were invited to participate in a Geology Merit Badge program. Boys who did not already possess the badge were allowed to self-select participation. The boys' content knowledge of geology, rocks, and minerals was pre- and post-tested. Boys were interviewed about their school and Scouting experiences; whether they believed their Scouting experiences and work in Merit Badges contributed to their success in school. Contributing educational theories included single-sex education, informal education with free-choice learning, learning styles, hands-on activities, and the social cognitive theory concept of self-efficacy. Boys who completed this study seemed to possess a greater knowledge of geology than they obtained in school. If boys who complete the Boy Scout Geology Merit Badge receive additional geological training, their field experiences and knowledge acquired through this learning experience will be beneficial, and a basis for continued scaffolding of geologic knowledge.

  18. Engendering Children of the Resistance: Models of Gender and Scouting in China, 1919–1937

    Directory of Open Access Journals (Sweden)

    Margaret Mih Tillman

    2014-12-01

    Full Text Available In the 1920s and 1930s, Chinese adapted scouting, which had originally been developed to masculinize British youth as future colonial troops. While Chinese families and teachers valued scouting as a form of outdoor recreation, Chiang Kai-shek and the Guomindang after 1927 connected scouting to preparation for military training. In addition to fostering masculinity among boys, the Chinese Scouting Association also directed Girl Scouts with new models of patriotic girlhood. The Guomindang promoted the distinct femininity of the Girl Scouts and channeled girls’ patriotism into nursing. As China entered World War II, Girl Scouts became significant symbols of patriotism in an increasingly militarized children’s culture. The Guomindang showcased Yang Huimin, a Girl Scout and heroine in the Battle of Sihang Warehouse, as a spokesperson for the Nationalist cause, but it could not fully control her public image.

  19. Collaborating with Planetaria to Improve Girl Scout's Appreciation of Astronomy

    Science.gov (United States)

    Adams, Mitzi; Phillips, Tony; Whitt, April

    2003-01-01

    We have collaborated with two planetaria, Fernbank Science Center's Jim Cherry planetarium in Atlanta, Georgia and the Von Braun Planetarium in Huntsville, Alabama to enhance the appreciation of various astronomical topics among Girl Scouts. Major events sponsored by our partnership were sleepovers in the planetaria during which we studied the total solar eclipse of June 2001 and observed the Eta Aquarid meteor shower of May 2003. Other events included programs on stellar spectroscopy and space physics. As an added inducement for participation, we have sponsored the production of "pins", which Girl Scouts can earn after satisfying specific requirements. This poster will show samples of the pins, requirements, and online resources for the Girl Scouts.

  20. Core domain and outcome measurement sets for shoulder pain trials are needed: Systematic review of physical therapy trials

    NARCIS (Netherlands)

    M.J. Page (Matthew J.); J.E. McKenzie (Joanne E.); S.E. Green (Sally E.); D.E. Beaton (Dorcas E.); N.B. Jain (Nitin B.); M. Lenza (Mario); A.P. Verhagen (Arianne); S. Surace (Stephen); J. Deitch (Jessica); R. Buchbinder (Rachelle)

    2015-01-01

    textabstractObjectives To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain). Study Design and Setting We included

  1. System Engineering Analysis For Improved Scout Business Information Systems

    Energy Technology Data Exchange (ETDEWEB)

    Van Slyke, D. A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2017-01-30

    The project uses system engineering principles to address the need of Boy Scout leaders for an integrated system to facilitate advancement and awards records, leader training and planning for meetings and activities. Existing products to address needs of Scout leaders and relevant stakeholders function to support record keeping and some communication functions but opportunity exists for a better system to fully integrate these functions with training delivery and recording, activity planning along with feedback and information gathering from stakeholders. Key stakeholders for the sytem include Scouts and their families, leaders, training providers, sellers of supplies and awards, content generators and facilities that serve Scout activities. Key performance parameters for the system are protection of personal information, availability of current information, information accuracy and information content that has depth. Implementation concepts considered for the system include (1) owned and operated by Boy Scouts of America, (2) Contracted out to a vendor (3) distributed system that functions with BSA managed interfaces. The selected concept is to contract out to a vendor to maximize the likelihood of successful integration and take advantage of the best technology. Development of requirements considers three key use cases (1) System facilitates planning a hike with training needed satisfied in advance and advancement recording real time (2) Scheduling and documenting in-person training, (3) Family interested in Scouting receives information and can request follow-up. Non-functional requirements are analyzed with the Quality Function Deployment tool. Requirement addressing frequency of backup, compatibility with legacy and new technology, language support, software update are developed to address system reliability and intuitive interface. System functions analyzed include update of activity database, maintenance of advancement status, archive of documents, and

  2. Registration status and outcome reporting of trials published in core headache medicine journals.

    Science.gov (United States)

    Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

    2015-11-17

    To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

  3. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  4. Lunar scout: A Project Artemis proposal

    Science.gov (United States)

    The results of a student project to design a lunar lander in the context of a specifically defined mission are presented. The Lunar Scout will be launched from Cape Canaveral, Florida onboard a Delta II launch vehicle. The Delta II will carry the lander and its payload to a 1367 km orbit. Once it reaches that altitude, a STAR 48A solid rocket motor will kick the spacecraft into a lunar trajectory. After burnout of the lunar insertion motor, it will be jettisoned from the spacecraft. The flight from the earth to the moon will take approximately 106.4 hours. During this time the battery, which was fully charged prior to launch, will provide all power to the spacecraft. Every hour, the spacecraft will use its sun sensors and star trackers to update its position, maintain some stabilization and relay it back to earth using the dipole antennas. At the start of its lunar trajectory, the spacecraft will fire one of its 1.5 N thrusters to spin in at a very small rate. The main reason for this is to prevent one side of the spacecraft from overheating in the sun. When the spacecraft nears the moon, it will orient itself for the main retro burn. At an altitude of 200 km, a 4400 N bipropellant liquid thruster will ignite to slow the spacecraft. During the burn, the radar altimeter will be turned on to guide the spacecraft. The main retro rocket will slow the lander to 10 m/s at an approximate altitude of 40 km above the moon. From there, the space craft will use four 4.5 N hydrazine vertical thrusters and 1.5 N horizontal thrusters to guide the spacecraft to a soft landing. Once on the ground, the lander will shutoff the radar and attitude control systems. After the debris from the impact has settled, the six solar panels will be deployed to begin recharging the batteries and to power up the payload. The feedhorn antenna will then rotate to fix itself on the earth.

  5. A general method for handling missing binary outcome data in randomized controlled trials

    OpenAIRE

    Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen

    2014-01-01

    Aims The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. Design We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models. Setting We apply our general method to data from two smoking cessation trials. Partici...

  6. The weight lowering effect of sibutramine and its impact on serum lipids in cardiovascular high risk patients with and without type 2 diabetes mellitus - an analysis from the SCOUT lead-in period

    Directory of Open Access Journals (Sweden)

    James Philip T

    2010-02-01

    Full Text Available Abstract Background Obesity, type 2 diabetes mellitus (T2D and unhealthy blood lipid profile are strongly associated with the risk of developing cardiovascular disease (CVD. We examined whether blood lipid changes with short term administration of the weight lowering drug, sibutramine and lifestyle modification in obese and overweight high-risk patients was associated with T2D status at screening. Methods The Sibutramine Cardiovascular OUTcomes (SCOUT trial included obese and overweight patients at increased risk of cardiovascular events. All patients received guidance on diet and exercise plus once-daily 10 mg sibutramine during the 6-week, single blind lead-in period. Multivariable regression models were used to investigate factors associated with changes in lipid levels during the first four weeks of treatment. Results A total of 10 742 patients received at least one dose of sibutramine during the 6-week lead-in period of SCOUT. After four weeks, patients experienced mean reductions in low density lipoprotein (LDL-C 0.19 mmol/L, high density lipoprotein (HDL-C 0.019 mmol/L, very low density lipoprotein (VLDL-C 0.08 mmol/L, total cholesterol (TC 0.31 mmol/L and triglycerides 0.24 mmol/L (p 2 decrease in BMI in patients with T2D was associated with -0.09 mmol/L in LDL-C (P Conclusion Short term weight management with sibutramine therapy in obese or overweight high-risk patients induced significant mean reductions for all lipids. Those without T2D benefited most. Patients with hyperlipidaemia and the less obese patients also had greater falls in LDL-C and TC during weight loss. The trial is registered at ClinicalTrial.gov number: NCT00234832.

  7. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn

    2008-01-01

    Aims To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial-2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA). Methods and results The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT......-BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of ... enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all...

  8. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

    Science.gov (United States)

    Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

    2017-12-22

    The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

  9. Seeding Social Norms about Energy Conservation among Girl Scouts

    Science.gov (United States)

    Bernstein, Debra; Puttick, Gillian

    2014-01-01

    Three studies examined whether a social norm message (SNM) to Girl Scouts who had completed an energy conservation program would impact behavior and attitudes. Studies 1 and 2 were conducted with girls recently completing the program, study 3 was conducted with girls completing the program one year earlier. Results suggest that the SNM may impact…

  10. Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

    Science.gov (United States)

    Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

    2017-10-01

    Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy

  11. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

    DEFF Research Database (Denmark)

    Liu, Jian-Ping; Han, Mei; Li, Xin-Xue

    2013-01-01

    Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

  12. Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

    Science.gov (United States)

    Smith, Colleen

    2015-01-01

    Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

  13. Girl Scouts and Subject Matter Experts: What’s the Connection?

    Science.gov (United States)

    Harman, Pamela; Girls Scouts of Northern California, Girl Scouts USA, Astronomical Society of the Pacifica, Univeristy of Arizona, and ARIES Scientific.

    2018-01-01

    Reaching for the Stars: NASA Science for Girl Scouts (Girl Scout Stars) fosters interaction between Girl Scouts and NASA Subject Matter Experts (SMEs), disseminates NASA STEM education-related resources, and engages Girl Scouts in NASA science and programs through space science badges and summer camps.A space science badge is in development for each of the six levels of Girl Scouts: Daisies, Grades K – 1; Brownies, Grades 2 -3; Juniors, Grades 4 -5; Cadettes, Grades 6 -8; Seniors, Grades 9 -10; and Ambassadors, Grades 11 -12. Indirectly, SMEs will reach tens of thousands of girls through the badges. SETI Institute SMEs Institute and SME Co-Is located at ARIES Scientific, Astronomical Society of the Pacific, University of Arizona, and Girl Scouts of Northern California developed and modified astronomy activities for the Girl Scouts USA badge writers to finesse into the Girl Scout formats. Revisions are reviewed by SMEs for accuracy. Each badge includes a step option that encourages girls to connect with SMEs, and recommendations for volunteers.A total of 127 girls from 31 states and the District of Columbia attendedTotal Eclipse Destination Camps at three locations. SMEs led activities and tours, inspiring girls to consider STEM careers. University of Arizona (U of A) SMEs lead Astronomy Camp for Volunteers, enabling volunteers to lead and inspire Girl Scouts in their respective Girl Scout Councils. A Destination Camp for Girl Scouts was also held at U of A. Girls experience authentic astronomy, learning how to collect and analyze data.Eleven teams comprised of two Girl Scouts, a volunteer or Council Staff, and an amateur astronomer attended Astronomy Club Camp, held at NASA GSFC. SMEs delivered science content. The girls will lead the formation of astronomy clubs in their councils, and will train their successors. SMEs will present and coach the clubs during monthly webinars.This presentation will highlight success and discuss lessons learned that are applicable

  14. The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials

    NARCIS (Netherlands)

    Eriksson, Goran; Calverley, Peter M.; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Lindberg, Magnus; Fageras, Malin; Postma, Dirkje S.

    2017-01-01

    Background: When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in

  15. Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases.

    Science.gov (United States)

    Artusi, Carlo Alberto; Mishra, Murli; Latimer, Patricia; Vizcarra, Joaquin A; Lopiano, Leonardo; Maetzler, Walter; Merola, Aristide; Espay, Alberto J

    2018-01-01

    We sought to review the landscape of past, present, and future use of technology-based outcome measures (TOMs) in clinical trials of neurodegenerative disorders. We systematically reviewed PubMed and ClinicalTrials.gov for published and ongoing clinical trials in neurodegenerative disorders employing TOMs. In addition, medical directors of selected pharmaceutical companies were surveyed on their companies' ongoing efforts and future plans to integrate TOMs in clinical trials as primary, secondary, or exploratory endpoints. We identified 164 published clinical trials indexed in PubMed that used TOMs as outcome measures in Parkinson disease (n = 132) or other neurodegenerative disorders (n = 32). The ClinicalTrials.gov search yielded 42 clinical trials using TOMs, representing 2.7% of ongoing trials. Sensor-based technology accounted for over 75% of TOMs applied. Gait and physical activity were the most common targeted domains. Within the next 5 years, 83% of surveyed pharmaceutical companies engaged in neurodegenerative disorders plan to deploy TOMs in clinical trials. Although promising, TOMs are underutilized in clinical trials of neurodegenerative disorders. Validating relevant endpoints, standardizing measures and procedures, establishing a single platform for integration of data and algorithms from different devices, and facilitating regulatory approvals should advance TOMs integration into clinical trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

    NARCIS (Netherlands)

    Mohr, J.P.; Overbey, J.R.; Kummer, R. von; Stefani, M.A.; Libman, R.; Stapf, C.; Parides, M.K.; Pile-Spellman, J.; Moquete, E.; Moy, C.S.; Vicaut, E.; Moskowitz, A.J.; Harkness, K.; Cordonnier, C.; Biondi, A.; Houdart, E.; Berkefeld, J.; Klijn, C.J.M.; Barreau, X.; Kim, H.; Hartmann, A.

    2017-01-01

    OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults >/=18

  17. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

    NARCIS (Netherlands)

    Mohr, J P; Overbey, Jessica R; von Kummer, Ruediger; Stefani, Marco A; Libman, Richard; Stapf, Christian; Parides, Michael K; Pile-Spellman, John; Moquete, Ellen; Moy, Claudia S; Vicaut, Eric; Moskowitz, Alan J; Harkness, Kirsty; Cordonnier, Charlotte; Biondi, Alessandra; Houdart, Emmanuel; Berkefeld, Joachim; Klijn, Karin J M; Barreau, Xavier; Kim, Helen; Hartmann, Andreas; van Dijk, J. Marc C.; Luijckx, Gert Jan

    2017-01-01

    OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18

  18. Cognitive Scout Node for Communication in Disaster Scenarios

    Directory of Open Access Journals (Sweden)

    Rajesh K. Sharma

    2012-01-01

    highly desired to manage unexpected situations that may happen in a disaster scenario. The scout node proposed in this paper is an extended concept based on a powerful CR node in a heterogeneous nodes environment which takes a leading role for highly flexible, fast, and robust establishment of cooperative wireless links in a disaster situation. This node should have two components: one is a passive sensor unit that collects and stores the technical knowledge about the electromagnetic environment in a data processing unit so-called “radio environment map” in the form of a dynamically updated database, and other is an active transceiver unit which can automatically be configured either as a secondary node for opportunistic communication or as a cooperative base station or access point for primary network in emergency communications. Scout solution can be viable by taking advantage of the technologies used by existing radio surveillance systems in the context of CR.

  19. Gradient Scouting in Reversed-Phase HPLC Revisited

    Science.gov (United States)

    Alcazar, A.; Jurado, J. M.; Gonzalez, A. G.

    2011-01-01

    Gradient scouting is the best way to decide the most suitable elution mode in reversed-phase high-performance liquid chromatography (RP-HPLC). A simple rule for this decision involves the evaluation of the ratio [delta]t/t[subscript G] (where [delta]t is the difference in the retention time between the last and the first peak and t[subscript G] is…

  20. Motor outcome measures in Huntington disease clinical trials.

    Science.gov (United States)

    Reilmann, Ralf; Schubert, Robin

    2017-01-01

    Deficits in motor function are a hallmark of Huntington disease (HD). The Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) is a categoric clinical rating scale assessing multiple domains of motor disability in HD. The UHDRS-TMS or subsets of its items have served as primary or secondary endpoints in numerous clinical trials. In spite of a well-established video-based annual online certification system, intra- and interrater variability, subjective error, and rater-induced placebo effects remain a concern. In addition, the UHDRS-TMS was designed to primarily assess motor symptoms in manifest HD. Recently, advancement of technology resulted in the introduction of the objective Q-Motor (i.e., Quantitative-Motor) assessments in biomarker studies and clinical trials in HD. Q-Motor measures detected motor signs in blinded cross-sectional and longitudinal analyses of manifest, prodromal, and premanifest HD cohorts up to two decades before clinical diagnosis. In a multicenter clinical trial in HD, Q-Motor measures were more sensitive than the UHDRS-TMS and exhibited no placebo effects. Thus, Q-Motor measures are currently explored in several multicenter trials targeting both symptomatic and disease-modifying mechanisms. They may supplement the UHDRS-TMS, increase the sensitivity and reliability in proof-of-concept studies, and open the door for phenotype assessments in clinical trials in prodromal and premanifest HD. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. SCANDCLEFT RANDOMIZED TRIALS: SPEECH OUTCOMES IN 5-YEAR-OLDS WITH UCLP - velopharyngeal competency and hypernasality

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth

    2017-01-01

    Background and aim: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP...... (136 girls, 255 boys) were available and perceptually analysed. The main outcome measures were VPC and hypernasality from blinded assessments. Results: There were no statistically significant differences between the prevalences in the arms in any of the trials. VPC: Trial 1, A: 58%, B: 61%; Trial 2, A......: 57%, C: 54%; Trial 3, A: 35%, D: 51%. No hypernasality: Trial 1, A: 54%, B: 44%; Trial 2, A: 47%, C: 51%; Trial 3, A: 34%, D: 49%. Conclusions: No differences were found regarding VPC and hypernasality at age 5 years after different methods for primary palatal repair. The burden of care in terms...

  2. Missed Lung Cancers on the Scout View: Do We Look Every Time?

    Directory of Open Access Journals (Sweden)

    Sarfraz Ahmed Nazir

    2013-01-01

    Full Text Available Scout views are digital radiographs obtained to aid planning of the subsequent computed tomography (CT examination. Review of these scout views may provide additional information not demonstrated on the axial images, but such reviews may not necessarily be performed routinely, especially in the context of abdominopelvic CT studies. We illustrate the value of the scout images by presenting a series of representative cases of missed pulmonary neoplasms in five patients who originally underwent such examinations.

  3. Sensitivity of adaptive enrichment trial designs to accrual rates, time to outcome measurement, and prognostic variables

    Directory of Open Access Journals (Sweden)

    Tianchen Qian

    2017-12-01

    Full Text Available Adaptive enrichment designs involve rules for restricting enrollment to a subset of the population during the course of an ongoing trial. This can be used to target those who benefit from the experimental treatment. Trial characteristics such as the accrual rate and the prognostic value of baseline variables are typically unknown when a trial is being planned; these values are typically assumed based on information available before the trial starts. Because of the added complexity in adaptive enrichment designs compared to standard designs, it may be of special concern how sensitive the trial performance is to deviations from assumptions. Through simulation studies, we evaluate the sensitivity of Type I error, power, expected sample size, and trial duration to different design characteristics. Our simulation distributions mimic features of data from the Alzheimer's Disease Neuroimaging Initiative cohort study, and involve two subpopulations based on a genetic marker. We investigate the impact of the following design characteristics: the accrual rate, the time from enrollment to measurement of a short-term outcome and the primary outcome, and the prognostic value of baseline variables and short-term outcomes. To leverage prognostic information in baseline variables and short-term outcomes, we use a semiparametric, locally efficient estimator, and investigate its strengths and limitations compared to standard estimators. We apply information-based monitoring, and evaluate how accurately information can be estimated in an ongoing trial.

  4. Core outcome measurement instruments for clinical trials in non-specific low back pain

    NARCIS (Netherlands)

    Chiarotto, Alessandro; Boers, Maarten; Deyo, Richard A; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Christine Lin, Chung-Wei; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Terwee, Caroline B; Ostelo, Raymond W

    2017-01-01

    To standardize outcome reporting in clinical trials of patients with non-specific low back pain (LBP), an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of consensus on

  5. Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy

    DEFF Research Database (Denmark)

    Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen

    2017-01-01

    AIM: Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. METHODS: We searched major databases without language restrictions for randomized controlled...... trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting...... as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. RESULTS: Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60...

  6. Scout: orbit analysis and hazard assessment for NEOCP objects

    Science.gov (United States)

    Farnocchia, Davide; Chesley, Steven R.; Chamberlin, Alan B.

    2016-10-01

    It typically takes a few days for a newly discovered asteroid to be officially recognized as a real object. During this time, the tentative discovery is published on the Minor Planet Center's Near-Earth Object Confirmation Page (NEOCP) until additional observations confirm that the object is a real asteroid rather than an observational artifact or an artificial object. Also, NEOCP objects could have a limited observability window and yet be scientifically interesting, e.g., radar and lightcurve targets, mini-moons (temporary Earth captures), mission accessible targets, close approachers or even impactors. For instance, the only two asteroids discovered before an impact, 2008 TC3 and 2014 AA, both reached the Earth less than a day after discovery. For these reasons we developed Scout, an automated system that provides an orbital and hazard assessment for NEOCP objects within minutes after the observations are available. Scout's rapid analysis increases the chances of securing the trajectory of interesting NEOCP objects before the ephemeris uncertainty grows too large or the observing geometry becomes unfavorable. The generally short observation arcs, perhaps only a few hours or even less, lead severe degeneracies in the orbit estimation process. To overcome these degeneracies Scout relies on systematic ranging, a technique that derives possible orbits by scanning a grid in the poorly constrained space of topocentric range and range rate, while the plane-of-sky position and motion are directly tied to the recorded observations. This scan allows us to derive a distribution of the possible orbits and in turn identify the NEOCP objects of most interest to prioritize followup efforts. In particular, Scout ranks objects according to the likelihood of an impact, estimates the close approach distance, the Earth-relative minimum orbit intersection distance and v-infinity, and computes scores to identify objects more likely to be an NEO, a km-sized NEO, a Potentially

  7. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review

    DEFF Research Database (Denmark)

    Cordoba Currea, Gloria Cristina; Schwartz, Lisa; Woloshin, Steven

    2010-01-01

    extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component. RESULTS: Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three...... components (range 2-9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital...

  8. Old-fashioned charm and newfangled electronics make today's oil scouts formidable figures

    International Nuclear Information System (INIS)

    Lorenz, A.

    1999-01-01

    A profile of oil scouting, a secretive trade within the petroleum industry, was presented. Scouting began as early as 1949 when, in a fiercely competitive industry, a scout had to gain any information anyway he could regarding a competitor's drilling activity. Scouts were particularly useful when the industry was new because it was profitable to pay a field scout to watch a competitor's well from a hilltop with binoculars. If a scout informed their company that a given lease looked promising, the company would snap up that lease and the scout earned his wages many times over. Today's oil scout is more likely to be an independent consultant than a company employee. Their equipment ranges from devices such as parabolic microphones, wireless transmitters, night vision goggles, de-bugging devices, tools for listening through solid objects, and cell phone monitors. Acquired information can be invaluable and can prevent companies from making expensive mistakes, particularly in take-over situations. Estimates range from 100 to 150 independent scouts in Alberta. 2 figs

  9. A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten Bogh; Lund, Hans; Guyatt, GH

    2010-01-01

    Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta-analyses ......Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta...... composite disability scores. Conclusions As choosing the most favorable PROs from individual trials can overestimate the effect compared to a systematic approach, using a prioritized list as presented in this study is recommended to reduce reviewer's likelihood of biased selection of PROs in meta-analyses....

  10. Survivorship care plans: are randomized controlled trials assessing outcomes that are relevant to stakeholders?

    Science.gov (United States)

    Birken, Sarah A; Urquhart, Robin; Munoz-Plaza, Corrine; Zizzi, Alexandra R; Haines, Emily; Stover, Angela; Mayer, Deborah K; Hahn, Erin E

    2018-03-23

    The purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs' effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs' outcomes. We identified RCTs' outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs' outcomes onto stakeholder-identified outcomes. RCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors' perspectives. RCTs of SCPs' effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs' effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders. SCPs' effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.

  11. Massed Trials versus Trials Embedded into Game Play: Child Outcomes and Preference

    Science.gov (United States)

    Ledford, Jennifer R.; Chazin, Kate T.; Harbin, Emilee R.; Ward, Sarah E.

    2017-01-01

    Limited data are available regarding how response prompting procedures should be used in early childhood settings. The purpose of this study was to compare the efficiency of progressive time delay instruction presented via two trial arrangements: massed and embedded. During massed trial sessions, a short instructional session was conducted,…

  12. Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials.

    Science.gov (United States)

    Hopewell, Sally; Witt, Claudia M; Linde, Klaus; Icke, Katja; Adedire, Olubusola; Kirtley, Shona; Altman, Douglas G

    2018-01-11

    Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the

  13. Comparison between the outcome of trial of labour and elective ...

    African Journals Online (AJOL)

    Foetal outcome was assessed based on APGAR score at five minutes, need for admission to the new born unit and the occurrence of early neonatal death. Results: A total of 142 participants were recruited of which 71 had undergone TOL and 71 had undergone ERCS. Clinical pelvimetry was the most common criteria used ...

  14. Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S

    2003-06-01

    Full Text Available Abstract Background Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" Method For three different outcome measures, absolute difference (DIF, relative risk (RR, and odds ratio (OR, we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox. Results For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. Conclusion The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

  15. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

    Directory of Open Access Journals (Sweden)

    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  16. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  17. Brachytherapy reconstruction using orthogonal scout views from the CT

    International Nuclear Information System (INIS)

    Perez, J.; Lliso, F.; Carmona, V.; Bea, J.; Tormo, A.; Petschen, I.

    1996-01-01

    Introduction: CT assisted brachytherapy planning is demonstrating to have great advantages as external RT planning does. One of the problems we have found in this approach with the conventional gynecological Fletcher applicators is the high amount of artefacts (ovoids with rectal and vessical protections) in the CT slice. We have introduced a reconstruction method based on scout views in order to avoid this problem, allowing us to perform brachytherapy reconstruction completely CT assisted. We use a virtual simulation chain by General Electric Medical Systems. Method and discussion: Two orthogonal scout views (0 and 90 tube positions) are performed. The reconstruction method takes into account the virtual position of the focus and the fact that there is only divergence in the transverse plane. Algorithms developed for sources as well as for reference points localisation (A, B, lymphatic Fletcher trapezoid, pelvic wall, etc.) are presented. This method has the following practical advantages: the porte-cassette is not necessary, the image quality can be improved (it is very helpful in pelvic lateral views that are critical in conventional radiographs), the total time to get the data is smaller than for conventional radiographs (reduction of patient motion effects) and problems that appear in CT-slice based reconstruction in the case of strongly curved intrauterine applicators are avoided. Even though the resolution is smaller than in conventional radiographs it is good enough for brachytherapy. Regarding the CT planning this method presents the interesting feature that the co-ordinate system is the same for the reconstruction process that for the CT-slices set. As the application can be reconstructed from scout views and the doses can be evaluated on CT slices it is easier to correlate the dose values obtained for the traditional points with those provided by the CT information

  18. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  19. Self-declared stock ownership and association with positive trial outcome in randomized controlled trials with binary outcomes published in general medical journals: a cross-sectional study.

    Science.gov (United States)

    Falk Delgado, Alberto; Falk Delgado, Anna

    2017-07-26

    Describe the prevalence and types of conflicts of interest (COI) in published randomized controlled trials (RCTs) in general medical journals with a binary primary outcome and assess the association between conflicts of interest and favorable outcome. Parallel-group RCTs with a binary primary outcome published in three general medical journals during 2013-2015 were identified. COI type, funding source, and outcome were extracted. Binomial logistic regression model was performed to assess association between COI and funding source with outcome. A total of 509 consecutive parallel-group RCTs were included in the study. COI was reported in 74% in mixed funded RCTs and in 99% in for-profit funded RCTs. Stock ownership was reported in none of the non-profit RCTs, in 7% of mixed funded RCTs, and in 50% of for-profit funded RCTs. Mixed-funded RCTs had employees from the funding company in 11% and for-profit RCTs in 76%. Multivariable logistic regression revealed that stock ownership in the funding company among any of the authors was associated with a favorable outcome (odds ratio = 3.53; 95% confidence interval = 1.59-7.86; p < 0.01). COI in for-profit funded RCTs is extensive, because the factors related to COI are not fully independent, a multivariable analysis should be cautiously interpreted. However, after multivariable adjustment only stock ownership from the funding company among authors is associated with a favorable outcome.

  20. CT guided stereotaxy based on scout view imaging

    Energy Technology Data Exchange (ETDEWEB)

    Wester, K; Kjartansson, O; Bakke, S J

    1987-05-01

    A simple and inexpensive method for CT guided sterotaxy is described. The method requires no extra equipment in the interface between the computer tomograph and the stereotaxic frame, and could therefore easily be adopted in most neurosurgical units. With this method, information from the transaxial CT sections is transferred manually via the scout view image to the operation theater skull X-rays, and thereby to the stereotaxic frame. The method has proved to be sufficiently accurate for all current non-functional stereotaxic procedures in our department during 30 months of testing.

  1. CT guided stereotaxy based on scout view imaging

    International Nuclear Information System (INIS)

    Wester, K.; Kjartansson, O.; Bakke, S.J.; Rikshospitalet, Oslo

    1987-01-01

    A simple and inexpensive method for CT guided sterotaxy is described. The method requires no extra equipment in the interface between the computer tomograph and the stereotaxic frame, and could therefore easily be adopted in most neurosurgical units. With this method, information from the transaxial CT sections is transferred manually via the scout view image to the operation theater skull X-rays, and thereby to the stereotaxic frame. The method has proved to be sufficiently accurate for all current non-functional stereotaxic procedures in our department during 30 months of testing. (orig.)

  2. Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing: A Reproduction Analysis of the SMART-AF Trial.

    Science.gov (United States)

    Gay, Hawkins C; Baldridge, Abigail S; Huffman, Mark D

    2017-12-01

    Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. Analysis of the data was conducted between December 2016 and April 2017. Effectiveness outcomes included freedom from atrial arrhythmias after ablation and proportion of participants without any arrhythmia recurrence over the 12 months of follow-up after a 3-month blanking period. Safety outcomes included major adverse device- or procedure-related events. The SMART AF trial participants' mean age was 58.7 (10.8) years, and 72% were men. The time from initial proposal submission to final analysis was 11 months. Freedom from atrial arrhythmias at 12 months postprocedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the 2 analyses, but contact force range or regression models could not be reproduced. The feasibility of a reproduction analysis of the SMART-AF trial was demonstrated through an academic data-sharing platform. Data sharing can be

  3. Being Prepared: The Application of Character Building and the Beginning of the Boy Scouts of America.

    Science.gov (United States)

    Phelps, Richard

    The beginnings of the Boy Scouts are traced, with particular emphasis on ideological foundation, social reform objectives of the founders (Sir Robert Baden-Powell, Daniel Carter Beard, and Ernest Thompson) and its relationship to other reform movements of the Progressive Era. The philosophical base of scouting is characterized as: 1) a…

  4. The Control of Sexuality in the Early British Boy Scouts Movement

    Science.gov (United States)

    Pryke, Sam

    2005-01-01

    This article looks at the way in which the early (1907-1922) British Boy Scouts movement attempted to control sexuality through archival examination of the organization's preoccupation with preventing masturbation or, as it was generally referred to, "self abuse". Having briefly outlined the origination and nature of the Scouts, it considers why…

  5. 78 FR 38452 - Price for the 2013 Girl Scouts of the USA Young Collector Set

    Science.gov (United States)

    2013-06-26

    ... DEPARTMENT OF THE TREASURY United States Mint Price for the 2013 Girl Scouts of the USA Young Collector Set AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing a price of $54.95 for the 2013 Girl Scouts of the USA Young Collector Set. FOR...

  6. Art, Boys, and the Boy Scout Movement: Lord Baden-Powell

    Science.gov (United States)

    Chalmers, F. Graeme; Dancer, Andrea A.

    2007-01-01

    Robert Stephenson Smyth Baden-Powell (1857-1941), founder of the Boy Scout Movement in 1907, was a British military hero during the Boer War. Within an ethos and era of empire-building, athleticism, soldier-heroes and the pursuit of "manliness," Baden-Powell valued the arts and adapted his artistic skill to his wartime and Scouting activities. His…

  7. Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.

    Science.gov (United States)

    Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed

    2017-08-01

    There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

  8. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  9. Outcomes of clinical trial: tinnitus masking versus tinnitus retraining therapy.

    Science.gov (United States)

    Henry, James A; Schechter, Martin A; Zaugg, Tara L; Griest, Susan; Jastreboff, Pawel J; Vernon, Jack A; Kaelin, Christine; Meikle, Mary B; Lyons, Karen S; Stewart, Barbara J

    2006-02-01

    A controlled clinical study was conducted to evaluate prospectively the clinical efficacy of tinnitus masking (TM) and tinnitus retraining therapy (TRT) in military veterans having clinically significant tinnitus. Qualifying patients were placed into the two groups in an alternating manner (to avoid selection bias), and treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index) and the verbally administered TRT interview forms. Findings are presented from the three written questionnaires, and from two of the interview questions (percentage time aware of, and annoyed by, tinnitus). Outcomes were analyzed on an intent-to-treat basis, using a multilevel modeling approach. Of the 123 patients enrolled, 118 were included in the analysis. Both groups showed significant declines (improvements) on these measures, with the TRT decline being significantly greater than for TM. The greater declines in TRT compared to TM occurred most strongly in patients who began treatment with a "very big" tinnitus problem. When patients began treatment with a "moderate" tinnitus problem, the benefits of TRT compared to TM were more modest.

  10. Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review.

    Science.gov (United States)

    Gaudry, Stéphane; Messika, Jonathan; Ricard, Jean-Damien; Guillo, Sylvie; Pasquet, Blandine; Dubief, Emeline; Boukertouta, Tanissia; Dreyfuss, Didier; Tubach, Florence

    2017-12-01

    Intensivists' clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients. Literature search was conducted to identify eligible trials indexed from January to December 2013. Articles were eligible if they reported an RCT involving critically ill adult patients. We excluded phase II, pilot and physiological crossover studies. We assessed study characteristics. All primary and secondary outcomes were collected, described and classified using six categories of outcomes including patient-important outcomes (involving mortality at any time on the one hand and quality of life, functional/cognitive/neurological outcomes assessed after ICU discharge on the other). Of the 716 articles retrieved in 2013, 112 RCTs met the inclusion criteria. Most common topics were mechanical ventilation (27%), sepsis (19%) and nutrition (17%). Among the 112 primary outcomes, 27 (24%) were patient-important outcomes (mainly mortality, 21/27) but only six (5%) were patient-important outcomes besides mortality assessed after ICU discharge (functional disability = 4; quality of life = 2). Among the 598 secondary outcomes, 133 (22%) were patient-important outcomes (mainly mortality, 92/133) but only 41 (7%) were patient-important outcomes besides mortality assessed after ICU discharge (quality of life = 20, functional disability = 14; neurological/cognitive performance = 5; handicap = 1; post-traumatic stress = 1). Seventy-three RCTs (65%) reported at least one patient-important outcome but only 11 (10%) reported at least one patient-important outcome besides mortality assessed after ICU discharge. Patient-important outcomes are rarely primary

  11. Pre-procedural scout radiographs are unnecessary for routine pediatric fluoroscopic examinations

    Energy Technology Data Exchange (ETDEWEB)

    Creeden, Sean G.; Rao, Anil G.; Eklund, Meryle J.; Hill, Jeanne G.; Thacker, Paul G. [Medical University of South Carolina, Department of Radiology and Radiological Science, Charleston, SC (United States)

    2017-03-15

    Although practice patterns vary, scout radiographs are often routinely performed with pediatric fluoroscopic studies. However few studies have evaluated their utility in routine pediatric fluoroscopy. To evaluate the value of scout abdomen radiographs in routine barium or water-soluble enema, upper gastrointestinal (GI) series, and voiding cystourethrogram pediatric fluoroscopic procedures. We retrospectively evaluated 723 barium or water-soluble enema, upper GI series, and voiding cystourethrogram fluoroscopic procedures performed at our institution. We assessed patient history and demographics, clinical indication for the examination, prior imaging findings and impressions, scout radiograph findings, additional findings provided by the scout radiograph that were previously unknown, and whether the scout radiograph contributed any findings that significantly changed management. We retrospectively evaluated 723 fluoroscopic studies (368 males and 355 females) in pediatric patients. Of these, 700 (96.8%) had a preliminary scout radiograph. Twenty-three (3.2%) had a same-day radiograph substituted as a scout radiograph. Preliminary scout abdomen radiographs/same-day radiographs showed no new significant findings in 719 (99.4%) studies. New but clinically insignificant findings were seen in 4 (0.6%) studies and included umbilical hernia, inguinal hernia and hip dysplasia. No findings were found on the scout radiographs that would either alter the examination performed or change management with regard to the exam. Pre-procedural scout abdomen radiographs are unnecessary in routine barium and water-soluble enema, upper GI series, and voiding cystourethrogram pediatric fluoroscopic procedures and can be substituted with a spot fluoroscopic last-image hold. (orig.)

  12. Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

    Science.gov (United States)

    Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

    2017-04-01

    Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury

  13. Adaptive Programming Improves Outcomes in Drug Court: An Experimental Trial.

    Science.gov (United States)

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Benasutti, Kathleen M; Fox, Gloria; Croft, Jason R

    2012-04-01

    Prior studies in Drug Courts reported improved outcomes when participants were matched to schedules of judicial status hearings based on their criminological risk level. The current experiment determined whether incremental efficacy could be gained by periodically adjusting the schedule of status hearings and clinical case-management sessions in response to participants' ensuing performance in the program. The adjustments were made pursuant to a priori criteria specified in an adaptive algorithm. Results confirmed that participants in the full adaptive condition (n = 62) were more than twice as likely as those assigned to baseline-matching only (n = 63) to be drug-abstinent during the first 18 weeks of the program; however, graduation rates and the average time to case resolution were not significantly different. The positive effects of the adaptive program appear to have stemmed from holding noncompliant participants more accountable for meeting their attendance obligations in the program. Directions for future research and practice implications are discussed.

  14. Scout-view assisted interior micro-CT

    International Nuclear Information System (INIS)

    Sharma, Kriti Sen; Narayanan, Shree; Agah, Masoud; Holzner, Christian; Vasilescu, Dragoş M; Jin, Xin; Hoffman, Eric A; Yu, Hengyong; Wang, Ge

    2013-01-01

    Micro computed tomography (micro-CT) is a widely-used imaging technique. A challenge of micro-CT is to quantitatively reconstruct a sample larger than the field-of-view (FOV) of the detector. This scenario is characterized by truncated projections and associated image artifacts. However, for such truncated scans, a low resolution scout scan with an increased FOV is frequently acquired so as to position the sample properly. This study shows that the otherwise discarded scout scans can provide sufficient additional information to uniquely and stably reconstruct the interior region of interest. Two interior reconstruction methods are designed to utilize the multi-resolution data without significant computational overhead. While most previous studies used numerically truncated global projections as interior data, this study uses truly hybrid scans where global and interior scans were carried out at different resolutions. Additionally, owing to the lack of standard interior micro-CT phantoms, we designed and fabricated novel interior micro-CT phantoms for this study to provide means of validation for our algorithms. Finally, two characteristic samples from separate studies were scanned to show the effect of our reconstructions. The presented methods show significant improvements over existing reconstruction algorithms. (paper)

  15. Product mix of recreational tourism in the Balkan scout center

    Directory of Open Access Journals (Sweden)

    Kocevski Miloš

    2013-01-01

    Full Text Available The subject of research is tourist offer of a camp which would satisfy the needs of tourists who want an active recreation, with changeable and attractive facilities in the Balkan Scout Center (BSC of Jovac. The goal is to define a model for recreational tourism product mix of the Balkan Scout Center, based on the analysis and evaluation of the elements of supply and identifying the demand for a certain program content. The research was conducted from April to August 2012, as a part of activities implemented in BSC events: Easter camp, Summer camp and Volunteer camp. The sample consisted of 100 visitors (respondents; the administered instrument was a specifically designed questionnaire and the methods on which the analysis of the modeling was based were: frequency of occurrence, comparative analysis (Benchmarking, SWOT and PEST. The research results confirm the existence of necessary resources for the implementation of the contents in the field of recreational tourism in the BSC, and the possibility of implementation of the product mix that includes day trips and a variety of outdoor recreational activities.

  16. Design and Development of NEA Scout Solar Sail Deployer Mechanism

    Science.gov (United States)

    Sobey, Alexander R.; Lockett, Tiffany Russell

    2016-01-01

    The 6U (approx.10 cm x 20 cm x 30 cm) cubesat Near Earth Asteroid (NEA) Scout1, projected for launch in September 2018 aboard the maiden voyage of the Space Launch System, will utilize a solar sail as its main method of propulsion throughout its approx.3-year mission to a Near Earth Asteroid. Due to the extreme volume constraints levied onto the mission, an acutely compact solar sail deployment mechanism has been designed to meet the volume and mass constraints, as well as provide enough propulsive solar sail area and quality in order to achieve mission success. The design of such a compact system required the development of approximately half a dozen prototypes in order to identify unforeseen problems, advance solutions, and build confidence in the final design product. This paper focuses on the obstacles of developing a solar sail deployment mechanism for such an application and the lessons learned from a thorough development process. The lessons presented will have significant applications beyond the NEA Scout mission, such as the development of other deployable boom mechanisms and uses for gossamer-thin films in space.

  17. Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

    Science.gov (United States)

    Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

    2015-04-15

    Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

  18. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

    DEFF Research Database (Denmark)

    Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip

    2017-01-01

    OBJECTIVE: To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities. METHODS: We conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups t...

  19. Is More Better? Outcome and Dose of a Universal Drug Prevention Effectiveness Trial

    Science.gov (United States)

    Ferrer-Wreder, Laura; Cadely, Hans Saint-Eloi; Domitrovich, Celene E.; Small, Meg L.; Caldwell, Linda L.; Cleveland, Michael J.

    2010-01-01

    Two evidence-based interventions, Life Skills Training and TimeWise, were combined in an effectiveness trial. Participants were predominately African American youth (N = 715; M[subscript age] = 12). The study authors provide an empirical demonstration of the implications of incorporating dosage information in intervention outcome analyses. Study…

  20. Effect of physical activity on frailty and associated negative outcomes: the LIFE randomized trial

    Science.gov (United States)

    Background: Limited evidence suggests that physical activity may prevent frailty and associated negative outcomes in older adults. Definitive data from large, long-term, randomized trials are lacking. Objective: To determine whether a long-term structured moderate-intensity physical activity (PA) p...

  1. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

    Science.gov (United States)

    Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

    2016-01-01

    The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  2. Poor nutritional status on admission predicts poor outcomes after stroke: observational data from the FOOD trial.

    Science.gov (United States)

    2003-06-01

    Previous studies suggest that undernourished patients with acute stroke do badly. The data, however, are not robust. We aimed to reliably assess the importance of baseline nutritional status as an independent predictor of long-term outcome after stroke in a large prospective cohort enrolled in the Feed Or Ordinary Diet (FOOD) trial, a multicenter randomized trial evaluating various feeding policies. Patients admitted to hospital with a recent stroke were enrolled in the FOOD trial. Data on nutritional status and other clinical predictors of outcome were collected at trial entry. At 6 months, the coordinating center collected data on survival and functional status (modified Rankin Scale). Outcome assessment was done by researchers blinded to baseline assessments and treatment allocation. Between November 1996 and November 2001, 3012 patients were enrolled, and 2955 (98%) were followed up. Of the 275 undernourished patients, 102 (37%) were dead by final follow-up compared with only 445 (20%) of 2194 patients of normal nutritional status (odds ratio [OR], 2.32; 95% CI, 1.78 to 3.02). After adjustment for age, prestroke functional state, and stroke severity, this relationship, although weakened, still held (OR, 1.82; 95% CI, 1.34 to 2.47). Undernourished patients were more likely to develop pneumonia, other infections, and gastrointestinal bleeding during their hospital admission than other patients. These data provide reliable evidence that nutritional status early after stroke is independently associated with long-term outcome. It supports the rationale for the FOOD trial, which continues to recruit and aims to estimate the effect of different feeding regimes on outcome after stroke and thus determine whether the association observed in this study is likely to be causal.

  3. Missing continuous outcomes under covariate dependent missingness in cluster randomised trials.

    Science.gov (United States)

    Hossain, Anower; Diaz-Ordaz, Karla; Bartlett, Jonathan W

    2017-06-01

    Attrition is a common occurrence in cluster randomised trials which leads to missing outcome data. Two approaches for analysing such trials are cluster-level analysis and individual-level analysis. This paper compares the performance of unadjusted cluster-level analysis, baseline covariate adjusted cluster-level analysis and linear mixed model analysis, under baseline covariate dependent missingness in continuous outcomes, in terms of bias, average estimated standard error and coverage probability. The methods of complete records analysis and multiple imputation are used to handle the missing outcome data. We considered four scenarios, with the missingness mechanism and baseline covariate effect on outcome either the same or different between intervention groups. We show that both unadjusted cluster-level analysis and baseline covariate adjusted cluster-level analysis give unbiased estimates of the intervention effect only if both intervention groups have the same missingness mechanisms and there is no interaction between baseline covariate and intervention group. Linear mixed model and multiple imputation give unbiased estimates under all four considered scenarios, provided that an interaction of intervention and baseline covariate is included in the model when appropriate. Cluster mean imputation has been proposed as a valid approach for handling missing outcomes in cluster randomised trials. We show that cluster mean imputation only gives unbiased estimates when missingness mechanism is the same between the intervention groups and there is no interaction between baseline covariate and intervention group. Multiple imputation shows overcoverage for small number of clusters in each intervention group.

  4. The verdict on jury trials for juveniles: the effects of defendant's age on trial outcomes.

    Science.gov (United States)

    Warling, Diane; Peterson-Badali, Michele

    2003-01-01

    With the progression to more adult-like policies and procedures for youth in the justice system, the right to a jury trial has been extended to young offenders. These youth would not be tried by a jury of their peers, however, but by a jury of adults. The concern is that adult jurors may hold negative attitudes about youth that might influence their decision making in a case involving a young defendant. Two studies examined whether and under what conditions defendant's age affects jurors' decisions about the guilt and sentencing of an accused. In study 1, data were gathered from two samples of jury eligible adults: one university sample and one public sample. Mock jurors read written transcripts of a trial involving a defendant who was presented as either 13, 17, or 25 years of age. Results indicated that the defendant's age had no effect on mock jurors' verdict or their ratings of defendant guilt. However, younger defendants were granted shorter sentences than the adult defendants. In study 2, mock jurors read the same trial presented in study 1 but were asked to deliberate about the case and render group verdicts. These group verdicts did not differ significantly by defendant's age. Age-related themes that emerged from group deliberations were identified, and results indicated that age tended to be used as a mitigating factor in favor of youth rather than against them. These findings are discussed in terms of their implications for youth justice policy and practice. Copyright 2003 John Wiley & Sons, Ltd.

  5. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials

    DEFF Research Database (Denmark)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E

    2016-01-01

    in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety......OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety...... that patients consider relevant so that they will be able to make informed decisions. CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach....

  6. Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods.

    Science.gov (United States)

    Wei, John; Nygaard, Ingrid; Richter, Holly; Brown, Morton; Barber, Matthew; Xiao Xu; Kenton, Kimberly; Nager, Charles; Schaffer, Joseph; Visco, Anthony; Weber, Anne

    2009-04-01

    The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible

  7. Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery

    NARCIS (Netherlands)

    Oomens, M.A.E.M.; Lazzari, S.; Heymans, M.W.; Forouzanfar, T.

    2016-01-01

    The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and

  8. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    Energy Technology Data Exchange (ETDEWEB)

    Fairchild, Alysa, E-mail: alysa.fairchild@albertahealthservices.ca [Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta (Canada); Straube, William [Advanced Technology Consortium, Imaged-Guided Therapy QA Center, St. Louis, Missouri (United States); Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Followill, David [Radiological Physics Center, University of Texas MD Anderson Cancer Centre, Houston, Texas (United States)

    2013-10-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.

  9. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    International Nuclear Information System (INIS)

    Fairchild, Alysa; Straube, William; Laurie, Fran; Followill, David

    2013-01-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question

  10. Intraspinal neural stem cell transplantation in amyotrophic lateral sclerosis: phase 1 trial outcomes.

    Science.gov (United States)

    Feldman, Eva L; Boulis, Nicholas M; Hur, Junguk; Johe, Karl; Rutkove, Seward B; Federici, Thais; Polak, Meraida; Bordeau, Jane; Sakowski, Stacey A; Glass, Jonathan D

    2014-03-01

    The US Food and Drug Administration-approved trial, "A Phase 1, Open-Label, First-in-Human, Feasibility and Safety Study of Human Spinal Cord-Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis, Protocol Number: NS2008-1," is complete. Our overall objective was to assess the safety and feasibility of stem cell transplantation into lumbar and/or cervical spinal cord regions in amyotrophic lateral sclerosis (ALS) subjects. Preliminary results have been reported on the initial trial cohort of 12 ALS subjects. Here, we describe the safety and functional outcome monitoring results for the final trial cohort, consisting of 6 ALS subjects receiving 5 unilateral cervical intraspinal neural stem cell injections. Three of these subjects previously received 10 total bilateral lumbar injections as part of the earlier trial cohort. All injections utilized a novel spinal-mounted stabilization and injection device to deliver 100,000 neural stem cells per injection, for a dosing range up to 1.5 million cells. Subject assessments included detailed pre- and postsurgical neurological outcome measures. The cervical injection procedure was well tolerated and disease progression did not accelerate in any subject, verifying the safety and feasibility of cervical and dual-targeting approaches. Analyses on outcome data revealed preliminary insight into potential windows of stem cell biological activity and identified clinical assessment measures that closely correlate with ALS Functional Rating Scale-Revised scores, a standard assessment for ALS clinical trials. This is the first report of cervical and dual-targeted intraspinal transplantation of neural stem cells in ALS subjects. This approach is feasible and well-tolerated, supporting future trial phases examining therapeutic dosing and efficacy. © 2014 Child Neurology Society/American Neurological Association.

  11. A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

    Science.gov (United States)

    Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

    2014-09-01

    To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

  12. Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study.

    Science.gov (United States)

    Kolamunnage-Dona, Ruwanthi; Powell, Colin; Williamson, Paula Ruth

    2016-04-28

    Clinical trials with longitudinally measured outcomes are often plagued by missing data due to patients withdrawing or dropping out from the trial before completing the measurement schedule. The reasons for dropout are sometimes clearly known and recorded during the trial, but in many instances these reasons are unknown or unclear. Often such reasons for dropout are non-ignorable. However, the standard methods for analysing longitudinal outcome data assume that missingness is non-informative and ignore the reasons for dropout, which could result in a biased comparison between the treatment groups. In this article, as a post hoc analysis, we explore the impact of informative dropout due to competing reasons on the evaluation of treatment effect in the MAGNETIC trial, the largest randomised placebo-controlled study to date comparing the addition of nebulised magnesium sulphate to standard treatment in acute severe asthma in children. We jointly model longitudinal outcome and informative dropout process to incorporate the information regarding the reasons for dropout by treatment group. The effect of nebulised magnesium sulphate compared with standard treatment is evaluated more accurately using a joint longitudinal-competing risk model by taking account of such complexities. The corresponding estimates indicate that the rate of dropout due to good prognosis is about twice as high in the magnesium group compared with standard treatment. We emphasise the importance of identifying reasons for dropout and undertaking an appropriate statistical analysis accounting for such dropout. The joint modelling approach accounting for competing reasons for dropout is proposed as a general approach for evaluating the sensitivity of conclusions to assumptions regarding missing data in clinical trials with longitudinal outcomes. EudraCT number 2007-006227-12 . Registration date 18 Mar 2008.

  13. Energy behaviours of northern California Girl Scouts and their families

    International Nuclear Information System (INIS)

    Boudet, Hilary; Ardoin, Nicole M.; Flora, June; Armel, K. Carrie; Desai, Manisha; Robinson, Thomas N.

    2014-01-01

    Climate change is likely the most critical societal challenge to the futures of today's children. Mitigation will require a concerted effort to change household energy behaviour—electricity use, transportation and food consumption patterns. A first step to changing behaviour is to better understand current behaviour and its intrapersonal (knowledge and attitudes), interpersonal (norms, communication and behaviour) and contextual (demographics and geography) correlates. To date, our understanding of the energy behaviours of children is limited. To begin to fill this gap, we report the results of a survey on the electricity, transportation and food-related energy behaviours of 323 fourth- and fifth-grade girls and their parents in 31 Girl Scout troops in Northern California. Our findings show positive attitudes and perceived norms toward energy-saving behaviours among child and adult respondents, but low or moderate levels of knowledge, communication, and behaviour, particularly for behaviours that require adult assistance. Girls’ choices about electricity behaviours appear to be governed by intrapersonal and interpersonal influences, while transportation behaviour is constrained by geographic context. Food-related behaviour, particularly meat consumption, was not readily modelled. Policy and education-related implications for future interventions aimed at enhancing children's energy-saving behaviours are discussed. - Highlights: • We surveyed 323 fourth and fifth grade Girl Scouts and parents about energy behaviours. • We asked about electricity, transportation and food behaviour and its correlates. • Girls’ electricity behaviours are linked to intrapersonal and interpersonal influences. • Girls’ transportation behaviour is constrained by geographic context. • Girls’ food behaviour, particularly meat consumption, was not readily modelled

  14. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

  15. The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.

    Science.gov (United States)

    Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O'Brien, Kieran S; Glidden, David V; Ray, Kathryn J; Oldenburg, Catherine E; Zegans, Michael E; Whitcher, John P; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R

    2014-02-01

    To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Randomized, placebo-controlled, double-masked clinical trial. This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. The Integration of the Fire Scout Tactical Unmanned Aerial System into Littoral Combat Ship Missions

    National Research Council Canada - National Science Library

    Marsh, James J

    2007-01-01

    ...) is an effective mission multiplier for the Littoral Combat Ship (LCS). The U.S. Navy relies heavily on unmanned systems, such as the Fire Scout UAS, to enable LCS to conduct several complex littoral missions...

  17. Temperature-Driven Shape Changes of the Near Earth Asteroid Scout Solar Sail

    Science.gov (United States)

    Stohlman, Olive R.; Loper, Erik R.; Lockett, Tiffany E.

    2017-01-01

    Near Earth Asteroid Scout (NEA Scout) is a NASA deep space Cubesat, scheduled to launch on the Exploration Mission 1 flight of the Space Launch System. NEA Scout will use a deployable solar sail as its primary propulsion system. The sail is a square membrane supported by rigid metallic tapespring booms, and analysis predicts that these booms will experience substantial thermal warping if they are exposed to direct sunlight in the space environment. NASA has conducted sunspot chamber experiments to confirm the thermal distortion of this class of booms, demonstrating tip displacement of between 20 and 50 centimeters in a 4-meter boom. The distortion behavior of the boom is complex and demonstrates an application for advanced thermal-structural analysis. The needs of the NEA Scout project were supported by changing the solar sail design to keep the booms shaded during use of the solar sail, and an additional experiment in the sunspot chamber is presented in support of this solution.

  18. Momentum Management for the NASA Near Earth Asteroid Scout Solar Sail Mission

    Science.gov (United States)

    Heaton, Andrew; Diedrich, Benjamin L.; Orphee, Juan; Stiltner, Brandon; Becker, Christopher

    2017-01-01

    The Momentum Management (MM) system is described for the NASA Near Earth Asteroid Scout (NEA Scout) cubesat solar sail mission. Unlike many solar sail mission proposals that used solar torque as the primary or only attitude control system, NEA Scout uses small reaction wheels (RW) and a reaction control system (RCS) with cold gas thrusters, as described in the abstract "Solar Sail Attitude Control System for Near Earth Asteroid Scout Cubesat Mission." The reaction wheels allow fine pointing and higher rates with low mass actuators to meet the science, communication, and trajectory guidance requirements. The MM system keeps the speed of the wheels within their operating margins using a combination of solar torque and the RCS.

  19. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...... developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully...

  20. Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial

    Directory of Open Access Journals (Sweden)

    Scherjon Sicco A

    2009-09-01

    Full Text Available Abstract Background Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. Methods/Design The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention or placebo (control for twelve days or until delivery, whatever comes first. Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05. Discussion This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. Trial Registration Clinical trial registration: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.

  1. Cross-trial prediction of treatment outcome in depression: a machine learning approach.

    Science.gov (United States)

    Chekroud, Adam Mourad; Zotti, Ryan Joseph; Shehzad, Zarrar; Gueorguieva, Ralitza; Johnson, Marcia K; Trivedi, Madhukar H; Cannon, Tyrone D; Krystal, John Harrison; Corlett, Philip Robert

    2016-03-01

    Antidepressant treatment efficacy is low, but might be improved by matching patients to interventions. At present, clinicians have no empirically validated mechanisms to assess whether a patient with depression will respond to a specific antidepressant. We aimed to develop an algorithm to assess whether patients will achieve symptomatic remission from a 12-week course of citalopram. We used patient-reported data from patients with depression (n=4041, with 1949 completers) from level 1 of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D; ClinicalTrials.gov, number NCT00021528) to identify variables that were most predictive of treatment outcome, and used these variables to train a machine-learning model to predict clinical remission. We externally validated the model in the escitalopram treatment group (n=151) of an independent clinical trial (Combining Medications to Enhance Depression Outcomes [COMED]; ClinicalTrials.gov, number NCT00590863). We identified 25 variables that were most predictive of treatment outcome from 164 patient-reportable variables, and used these to train the model. The model was internally cross-validated, and predicted outcomes in the STAR*D cohort with accuracy significantly above chance (64·6% [SD 3·2]; p<0·0001). The model was externally validated in the escitalopram treatment group (N=151) of COMED (accuracy 59·6%, p=0.043). The model also performed significantly above chance in a combined escitalopram-buproprion treatment group in COMED (n=134; accuracy 59·7%, p=0·023), but not in a combined venlafaxine-mirtazapine group (n=140; accuracy 51·4%, p=0·53), suggesting specificity of the model to underlying mechanisms. Building statistical models by mining existing clinical trial data can enable prospective identification of patients who are likely to respond to a specific antidepressant. Yale University. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Factors and outcomes of decision making for cancer clinical trial participation.

    Science.gov (United States)

    Biedrzycki, Barbara A

    2011-09-01

    To describe factors and outcomes related to the decision-making process regarding participation in a cancer clinical trial. Cross-sectional, descriptive. Urban, academic, National Cancer Institute-designated comprehensive cancer center in the mid-Atlantic United States. 197 patients with advanced gastrointestinal cancer. Mailed survey using one investigator-developed instrument, eight instruments used in published research, and a medical record review. disease context, sociodemographics, hope, quality of life, trust in healthcare system, trust in health professional, preference for research decision control, understanding risks, and information. decision to accept or decline research participation and satisfaction with this decision. All of the factors within the Research Decision Making Model together predicted cancer clinical trial participation and satisfaction with this decision. The most frequently preferred decision-making style for research participation was shared (collaborative) (83%). Multiple factors affect decision making for cancer clinical trial participation and satisfaction with this decision. Shared decision making previously was an unrecognized factor and requires further investigation. Enhancing the process of research decision making may facilitate an increase in cancer clinical trial enrollment rates. Oncology nurses have unique opportunities as educators and researchers to support shared decision making by those who prefer this method for deciding whether to accept or decline cancer clinical trial participation.

  3. The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

    Directory of Open Access Journals (Sweden)

    Ji Yun Lee

    Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

  4. A simple method for analyzing data from a randomized trial with a missing binary outcome

    Directory of Open Access Journals (Sweden)

    Freedman Laurence S

    2003-05-01

    Full Text Available Abstract Background Many randomized trials involve missing binary outcomes. Although many previous adjustments for missing binary outcomes have been proposed, none of these makes explicit use of randomization to bound the bias when the data are not missing at random. Methods We propose a novel approach that uses the randomization distribution to compute the anticipated maximum bias when missing at random does not hold due to an unobserved binary covariate (implying that missingness depends on outcome and treatment group. The anticipated maximum bias equals the product of two factors: (a the anticipated maximum bias if there were complete confounding of the unobserved covariate with treatment group among subjects with an observed outcome and (b an upper bound factor that depends only on the fraction missing in each randomization group. If less than 15% of subjects are missing in each group, the upper bound factor is less than .18. Results We illustrated the methodology using data from the Polyp Prevention Trial. We anticipated a maximum bias under complete confounding of .25. With only 7% and 9% missing in each arm, the upper bound factor, after adjusting for age and sex, was .10. The anticipated maximum bias of .25 × .10 =.025 would not have affected the conclusion of no treatment effect. Conclusion This approach is easy to implement and is particularly informative when less than 15% of subjects are missing in each arm.

  5. Randomized Control Trial of COMPASS for Improving Transition Outcomes of Students with Autism Spectrum Disorder.

    Science.gov (United States)

    Ruble, Lisa A; McGrew, John H; Toland, Michael; Dalrymple, Nancy; Adams, Medina; Snell-Rood, Claire

    2018-06-01

    The postsecondary outcomes of individuals with autism spectrum disorder (ASD) are significantly worse than peers with other disabilities. One problem is the lack of empirically-supported transition planning interventions to guide services and help produce better outcomes. We applied an implementation science approach to adapt and modify an evidence-based consultation intervention originally tested with young children called the Collaborative Model for Promoting Competence and Success (COMPASS; Ruble et al., The collaborative model for promoting competence and success for students with ASD. Springer, New York, 2012a) and evaluate it for efficacy in a randomized controlled trial for transition-age youth. Results replicated findings with younger students with ASD that IEP outcomes were higher for COMPASS compared to the placebo control group (d = 2.1). Consultant fidelity was high and teacher adherence improved over time, replicating the importance of ongoing teacher coaching.

  6. Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

    Science.gov (United States)

    Margolis, Karen L; O'Connor, Patrick J; Morgan, Timothy M; Buse, John B; Cohen, Robert M; Cushman, William C; Cutler, Jeffrey A; Evans, Gregory W; Gerstein, Hertzel C; Grimm, Richard H; Lipkin, Edward W; Narayan, K M Venkat; Riddle, Matthew C; Sood, Ajay; Goff, David C

    2014-06-01

    To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50-0.91), BP (HR 0.74; 95% CI 0.55-1.00), or both (HR 0.71; 95% CI 0.52-0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02-1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group. In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality. © 2014 by the American Diabetes Association.

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

    Science.gov (United States)

    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

  8. Neurosurgical outcomes after intracerebral hemorrhage: results of the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST).

    Science.gov (United States)

    Steiner, Thorsten; Vincent, Catherine; Morris, Stephen; Davis, Stephen; Vallejo-Torres, Laura; Christensen, Michael C

    2011-01-01

    The value of neurosurgical interventions after spontaneous intracerebral hemorrhage (SICH) is uncertain. We evaluated clinical outcomes in patients diagnosed with SICH within 3 hours of symptom onset who underwent hematoma evacuation or external ventricular drainage (EVD) of the hematoma in the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST). FAST was a randomized, multicenter, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. Neurosurgical procedures (hematoma evacuation and external ventricular drainage) performed at any point after hospital admission were prospectively recorded. Clinical outcomes evaluated were post-SICH disability, as assessed by the modified Rankin Scale; neurologic impairment, as assessed by the National Institutes of Health Stroke Scale; and mortality at 90 days after SICH onset. The impact of neurosurgical procedures on clinical outcomes was evaluated using multivariate logistic regression analysis, controlling for relevant baseline characteristics. Fifty-five of 821 patients underwent neurosurgery. Patients who underwent hematoma evacuation or EVD were on average younger, had greater baseline neurologic impairment, and lower levels of consciousness compared with patients who did not undergo neurosurgery. After adjusting for these differences and other relevant baseline characteristics, we found that neurosurgery was generally associated with unfavorable outcomes at day 90. Among the patients who underwent hematoma evacuation, those with lobar ICH had less ICH expansion than those with deep gray matter ICH, and the smaller expansion was associated with lower mortality. ICH volume was substantially decreased in patients who underwent hematoma evacuation between 24 and 72 hours after hospital admission, and this was associated with better clinical outcome. In conclusion, a small number of patients who underwent neurosurgery in FAST exhibited no overall clinical benefit

  9. Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

    Science.gov (United States)

    Milette, Katherine; Roseman, Michelle; Thombs, Brett D

    2011-03-01

    The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  10. Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

    Science.gov (United States)

    Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

    2018-02-01

    Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

  11. Potential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial

    DEFF Research Database (Denmark)

    Sever, Peter; Dahlöf, Björn; Poulter, Neil

    2006-01-01

    A prespecified objective of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was to assess whether any synergistic effects were apparent between the lipid-lowering and blood-pressure-lowering regimens in preventing cardiovascular events....

  12. Statin treatment and stroke outcome in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Goldstein, L.B.; Amarenco, P.; Zivin, J.

    2009-01-01

    BACKGROUND AND PURPOSE: Laboratory experiments suggest statins reduce stroke severity and improve outcomes. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was a placebo-controlled, randomized trial designed to determine whether treatment with atorvastatin reduces...... or 4), moderate (modified Rankin Scale score 3 or 2), and mild (modified Rankin Scale score 1 or 0) outcome ischemic strokes and transient ischemic attacks and an increase in the proportion of event-free subjects randomized to atorvastatin (P

  13. Energy behaviours of northern California Girl Scouts and their families

    Energy Technology Data Exchange (ETDEWEB)

    Boudet, H; Ardoin, NM; Flora, J; Armel, KC; Desai, M; Robinson, TN

    2014-10-01

    Climate change is likely the most critical societal challenge to the futures of today's children. Mitigation will require a concerted effort to change household energy behaviour electricity use, transportation and food consumption patterns. A first step to changing behaviour is to better understand current behaviour and its intrapersonal (knowledge and attitudes), interpersonal (norms, communication and behaviour) and contextual (demographics and geography) correlates. To date, our understanding of the energy behaviours of children is limited. To begin to fill this gap, we report the results of a survey on the electricity, transportation and food-related energy behaviours of 323 fourth- and fifth-grade girls and their parents in 31 Girl Scout troops in Northern California. Our findings show positive attitudes and perceived norms toward energy-saving behaviours among child and adult respondents, but low or moderate levels of knowledge, communication, and behaviour, particularly for behaviours that require adult assistance. Girls' choices about electricity behaviours appear to be governed by intrapersonal and interpersonal influences, while transportation behaviour is constrained by geographic context. Food-related behaviour, particularly meat consumption, was not readily modelled. Policy and education-related implications for future interventions aimed at enhancing children's energy-saving behaviours are discussed. (C) 2014 Elsevier Ltd. All rights reserved.

  14. Statin therapy and clinical outcomes in myocardial infarction patients complicated by acute heart failure : insights from the EPHESUS trial

    NARCIS (Netherlands)

    Dobre, Daniela; Rossignol, Patrick; Murin, Jan; Parkhomenko, Alexander; Lamiral, Zohra; Krum, Henry; van Veldhuisen, Dirk J.; Pitt, Bertram; Zannad, Faiez

    Several clinical trials have shown that in patients with acute myocardial infarction (MI), statin therapy improves cardiovascular (CV) outcomes, but in these trials patients with acute heart failure (HF) were excluded or only a few were included. In patients with chronic HF, statin therapy does not

  15. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA (R))

    NARCIS (Netherlands)

    Marx, Nikolaus; Rosenstock, Julio; Kahn, Steven E.; Zinman, Bernard; Kastelein, John J.; Lachin, John M.; Espeland, Mark A.; Bluhmki, Erich; Mattheus, Michaela; Ryckaert, Bart; Patel, Sanjay; Johansen, Odd Erik; Woerle, Hans-Juergen

    2015-01-01

    CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (NCT01243424) is an ongoing, randomized trial in subjects with early type 2 diabetes and increased cardiovascular risk or established complications that will determine the long-term cardiovascular impact of linagliptin

  16. Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

    2015-06-01

    Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers

  17. 02A. Design, Methods, and Outcomes for Recent Clinical Trials Utilizing Ayurvedic Medicine, Yoga, and Meditation

    Science.gov (United States)

    Saper, Robert; Vinjamury, Sivarama; Elder, Charles

    2013-01-01

    Focus Area: Integrative Approaches to Care The panel discussants will present on the outcomes of four recent pragmatic trials covering the spectrum of Ayurvedic medicine, yoga, and meditation as therapeutic approaches for both acute and chronic conditions. The presenters will discuss: (1) a pilot study of a whole-systems Ayurveda and Yoga Therapy intervention for obesity; (2) a comparative effectiveness randomized controlled trial of hatha yoga, physical therapy, and education for non-specific chronic low back pain in low-income minority populations; (3) an investigation of the therapeutic usefulness of Shirodhara (Ayurvedic oil dripping therapy) as a treatment for insomnia; and (4) a discussion of the evidence base supporting implementation of meditation interventions in schools and workplace settings. Discussants will present information on study designs, research methodology, and outcome measure selection to highlight special considerations in conducting research on whole medical systems that use multi-target therapies and focus on patient-centered outcomes. Ayurvedic medicine and yoga are characterized by low-cost, noninvasive interventions that can be usefully offered as part of an integrative medicine therapeutic approach.

  18. Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes.

    Science.gov (United States)

    Weiser, Sheri D; Bukusi, Elizabeth A; Steinfeld, Rachel L; Frongillo, Edward A; Weke, Elly; Dworkin, Shari L; Pusateri, Kyle; Shiboski, Stephen; Scow, Kate; Butler, Lisa M; Cohen, Craig R

    2015-09-10

    Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. This is a pilot cluster randomized controlled trial. The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/μl, P security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.

  19. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John

    2013-01-01

    on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......-hoc nested case-control analysis in the ADVANCE trial in order to examine the association between insulin use and cancer. We encountered several methodological challenges that made the results difficult to interpret, including short duration of exposure of interest, lack of power, and correlation between...... exposure and potential confounders. Considering these challenges, we concluded that using the data would not enlighten the discussion about insulin use and cancer risk and only serve to further complicate any understanding. Therefore, we decided to use our experience to illustrate methodological challenges...

  20. Core outcome domains for clinical trials in non-specific low back pain.

    Science.gov (United States)

    Chiarotto, Alessandro; Deyo, Richard A; Terwee, Caroline B; Boers, Maarten; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Lin, Chung-Wei Christine; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Ostelo, Raymond W

    2015-06-01

    Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP. An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions. A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and

  1. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials.

    Science.gov (United States)

    Reddy, Vivek Y; Doshi, Shephal K; Kar, Saibal; Gibson, Douglas N; Price, Matthew J; Huber, Kenneth; Horton, Rodney P; Buchbinder, Maurice; Neuzil, Petr; Gordon, Nicole T; Holmes, David R

    2017-12-19

    The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time. The final results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, are reported with patients in both trials followed for 5 years. PREVAIL and PROTECT AF are prospective randomized clinical trials with patients randomized 2:1 to LAAC or warfarin; together, they enrolled 1,114 patients for 4,343 patient-years. Analyses are by intention-to-treat, and rates are events per 100 patient-years. For the PREVAIL trial, the first composite coprimary endpoint of stroke, systemic embolism (SE), or cardiovascular/unexplained death did not achieve noninferiority (posterior probability for noninferiority = 88.4%), whereas the second coprimary endpoint of post-procedure ischemic stroke/SE did achieve noninferiority (posterior probability for noninferiority = 97.5%); the warfarin arm maintained an unusually low ischemic stroke rate (0.73%). In the meta-analysis, the composite endpoint was similar between groups (hazard ratio [HR]: 0.820; p = 0.27), as were all-stroke/SE (HR: 0.961; p = 0.87). The ischemic stroke/SE rate was numerically higher with LAAC, but this difference did not reach statistical significance (HR: 1.71; p = 0.080). However, differences in

  2. Cataract Surgery Outcomes in Uveitis: The Multicenter Uveitis Steroid Treatment Trial.

    Science.gov (United States)

    Sen, H Nida; Abreu, Francis M; Louis, Thomas A; Sugar, Elizabeth A; Altaweel, Michael M; Elner, Susan G; Holbrook, Janet T; Jabs, Douglas A; Kim, Rosa Y; Kempen, John H

    2016-01-01

    To assess the visual outcomes of cataract surgery in eyes that received fluocinolone acetonide implant or systemic therapy with oral corticosteroids and immunosuppression during the Multicenter Uveitis Steroid Treatment (MUST) Trial. Nested prospective cohort study of patients enrolled in a randomized clinical trial. Patients that underwent cataract surgery during the first 2 years of follow-up in the MUST Trial. Visual outcomes of cataract surgery were evaluated 3, 6, and 9 months after surgery using logarithmic visual acuity charts. Change in visual acuity over time was assessed using a mixed-effects model. Best-corrected visual acuity. After excluding eyes that underwent cataract surgery simultaneously with implant surgery, among the 479 eyes in the MUST Trial, 117 eyes (28 eyes in the systemic, 89 in the implant group) in 82 patients underwent cataract surgery during the first 2 years of follow-up. Overall, visual acuity increased by 23 letters from the preoperative visit to the 3-month visit (95% confidence interval [CI], 17-29 letters; P uveitis onset, and hypotony were associated with worse preoperative visual acuity (P 0.05, test of interaction). After adjusting for other risk factors, there was no significant difference in the improvement in visual acuity between the 2 treatment groups (implant vs. systemic therapy, 2 letters; 95% CI, -10 to 15 letters; P = 0.70). Cataract surgery resulted in substantial, sustained, and similar visual acuity improvement in the eyes of patients with uveitis treated with the fluocinolone acetonide implant or standard systemic therapy. Published by Elsevier Inc.

  3. Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

    Energy Technology Data Exchange (ETDEWEB)

    Elskamp, I.J. van den; Boden, B.; Barkhof, F. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); Dattola, V. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); University of Messina, Department of Neurosciences, Psychiatric and Anaesthesiological Sciences, Messina (Italy); Knol, D.L. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); Filippi, M. [Scientific Institute and University Ospedale San Raffaele, Neuroimaging Research Unit, Milan (Italy); Kappos, L. [University Hospital, University of Basel, Department of Neurology, Basel (Switzerland); Fazekas, F. [Medical University of Graz, Department of Neurology, Graz (Austria); Wagner, K. [Bayer-Schering Pharma, Berlin (Germany); Pohl, C. [Bayer-Schering Pharma, Berlin (Germany); University Hospital Bonn, Department of Neurology, Bonn (Germany); Sandbrink, R. [Bayer-Schering Pharma, Berlin (Germany); Heinrich-Heine-University Dusseldorf, Department of Neurology, Dusseldorf (Germany); Polman, C.H. [VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands); Uitdehaag, B.M.J. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands)

    2010-10-15

    Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

  4. Is More Better? Outcome and Dose of a Universal Drug Prevention Effectiveness Trial

    Science.gov (United States)

    Ferrer-Wreder, Laura; Cadely, Hans Saint-Eloi; Domitrovich, Celene E.; Small, Meg L.; Caldwell, Linda L.; Cleveland, Michael J.

    2014-01-01

    Two evidence-based interventions, Life Skills Training and TimeWise, were combined in an effectiveness trial. Participants were predominately African American youth (N = 715; Mage = 12). The study authors provide an empirical demonstration of the implications of incorporating dosage information in intervention outcome analyses. Study results showed no program-related benefits for drug use. Results indicated intervention-related benefits for assertiveness and anxiety management skills and drug use intentions as well as a reduction in detrimental leisure motivations. High program exposure and lesson coverage tended to be connected to intervention benefits. Study findings also documented ways that dosage information provides insight into interventions and their effects. PMID:21053080

  5. Comparative brain transcriptomic analyses of scouting across distinct behavioural and ecological contexts in honeybees

    Science.gov (United States)

    Liang, Zhengzheng S.; Mattila, Heather R.; Rodriguez-Zas, Sandra L.; Southey, Bruce R.; Seeley, Thomas D.; Robinson, Gene E.

    2014-01-01

    Individual differences in behaviour are often consistent across time and contexts, but it is not clear whether such consistency is reflected at the molecular level. We explored this issue by studying scouting in honeybees in two different behavioural and ecological contexts: finding new sources of floral food resources and finding a new nest site. Brain gene expression profiles in food-source and nest-site scouts showed a significant overlap, despite large expression differences associated with the two different contexts. Class prediction and ‘leave-one-out’ cross-validation analyses revealed that a bee's role as a scout in either context could be predicted with 92.5% success using 89 genes at minimum. We also found that genes related to four neurotransmitter systems were part of a shared brain molecular signature in both types of scouts, and the two types of scouts were more similar for genes related to glutamate and GABA than catecholamine or acetylcholine signalling. These results indicate that consistent behavioural tendencies across different ecological contexts involve a mixture of similarities and differences in brain gene expression. PMID:25355476

  6. Optimizing cutoff scores for the Barthel Index and the modified Rankin Scale for defining outcome in acute stroke trials

    NARCIS (Netherlands)

    Uyttenboogaart, Maarten; Stewart, Roy E; Vroomen, Patrick C A J; De Keyser, Jacques; Luijckx, Gert-Jan

    Background and Purpose - There is little agreement on how to assess outcome in acute stroke trials. Cutoff scores for the Barthel Index (BI) and modified Rankin Scale (mRS) are frequently arbitrarily chosen to dichotomize favorable and unfavorable outcome. We investigated sensitivity and specificity

  7. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  8. Therapist facilitative interpersonal skills and training status: A randomized clinical trial on alliance and outcome.

    Science.gov (United States)

    Anderson, Timothy; Crowley, Mary Ellen J; Himawan, Lina; Holmberg, Jennifer K; Uhlin, Brian D

    2016-09-01

    Therapist effects, independent of the treatment provided, have emerged as a contributor to psychotherapy outcomes. However, past research largely has not identified which therapist factors might be contributing to these effects, though research on psychotherapy implicates relational characteristics. The present Randomized Clinical Trial tested the efficacy of therapists who were selected by their facilitative interpersonal skills (FIS) and training status. Sixty-five clients were selected from 2713 undergraduates using a screening and clinical interview procedure. Twenty-three therapists met with 2 clients for 7 sessions and 20 participants served in a no-treatment control group. Outcome and alliance differences for Training Status were negligible. High FIS therapists had greater pre-post client outcome, and higher rates of change across sessions, than low FIS therapists. All clients treated by therapists improved more than the silent control, but effects were greater with high FIS than low FIS therapists. From the first session, high FIS therapists also had higher alliances than low FIS therapists as well as significant improvements on client-rated alliance. Results were consistent with the hypothesis that therapists' common relational skills are independent contributors to therapeutic alliance and outcome.

  9. Respiratory Outcomes of the Surfactant Positive Pressure and Oximetry Randomized Trial

    Science.gov (United States)

    Stevens, Timothy P.; Finer, Neil N.; Carlo, Waldemar A.; Szilagyi, Peter G.; Phelps, Dale L.; Walsh, Michele C.; Gantz, Marie G.; Laptook, Abbot R.; Yoder, Bradley A.; Faix, Roger G.; Newman, Jamie E.; Das, Abhik; Do, Barbara T.; Schibler, Kurt; Rich, Wade; Newman, Nancy S.; Ehrenkranz, Richard A.; Peralta-Carcelen, Myriam; Vohr, Betty R.; Wilson-Costello, Deanne E.; Yolton, Kimberly; Heyne, Roy J.; Evans, Patricia W.; Vaucher, Yvonne E.; Adams-Chapman, Ira; McGowan, Elisabeth C.; Bodnar, Anna; Pappas, Athina; Hintz, Susan R.; Acarregui, Michael J.; Fuller, Janell; Goldstein, Ricki F.; Bauer, Charles R.; O’Shea, T. Michael; Myers, Gary J.; Higgins, Rosemary D.

    2014-01-01

    Objective To explore the early childhood pulmonary outcomes of infants who participated in the NICHD SUPPORT Trial, using a factorial design that randomized extremely preterm infants to lower vs. higher oxygen saturation targets and delivery room CPAP vs. intubation/surfactant, found no significant difference in the primary composite outcome of death or BPD. Study design The Breathing Outcomes Study, a prospective secondary to SUPPORT, assessed respiratory morbidity at 6 month intervals from hospital discharge to 18–22 months corrected age (CA). Two pre-specified primary outcomes, wheezing more than twice per week during the worst 2 week period and cough longer than 3 days without a cold were compared between each randomized intervention. Results One or more interviews were completed for 918 of 922 eligible infants. The incidence of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between study arms of either randomized intervention. Infants randomized to lower vs. higher oxygen saturation targets had similar risks of death or respiratory morbidities (except for croup, treatment with oxygen or diuretics at home). Infants randomized to CPAP vs. intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs. 36.5%, pCPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18–22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates. PMID:24725582

  10. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes.

    Science.gov (United States)

    Reitsma, Angela; Chu, Rong; Thorpe, Julia; McDonald, Sarah; Thabane, Lehana; Hutton, Eileen

    2014-09-26

    Clustering of outcomes at centers involved in multicenter trials is a type of center effect. The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials (RCTs) should account for center effects in their analysis, however most do not. The Early External Cephalic Version (EECV) trials published in 2003 and 2011 stratified by center at randomization, but did not account for center in the analyses, and due to the nature of the intervention and number of centers, may have been prone to center effects. Using data from the EECV trials, we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing (early or delayed) on the outcomes of cesarean section, preterm birth, and non-cephalic presentation at the time of birth. The data from the EECV pilot trial and the EECV2 trial were merged into one dataset. Fisher's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects. Seven statistical models that accounted for center effects were applied to the data. The models included: i) the Mantel-Haenszel test, ii) logistic regression with fixed center effect and fixed treatment effect, iii) center-size weighted and iv) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction, iv) logistic regression with random center effect and fixed treatment effect, v) logistic regression with random center effect and random treatment-by-center interaction, and vi) generalized estimating equations. For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial. The results were similar for the majority of the methods used to adjust for center, illustrating the robustness of the findings. Despite literature that suggests center effect can change the estimate of effect in

  11. Outcome reporting across randomised trials and observational studies evaluating treatments for Twin-Twin Transfusion Syndrome: a systematic review.

    Science.gov (United States)

    Perry, Helen; Duffy, James M N; Umadia, Ogochukwu; Khalil, Asma

    2018-04-01

    Twin-Twin Transfusion syndrome is associated with significant mortality and morbidity. Potential treatments require robust evaluation. The aim of this study was to evaluate outcome reporting across observational studies and randomised controlled trials assessing treatments for twin-twin transfusion syndrome (TTTS). Cochrane Central Register of Controlled Trials, EMBASE and Medline were searched from inception to August 2016. Observational studies and randomised controlled trials reporting outcomes following a treatment for TTTS in monochorionic-diamniotic twin pregnancies and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancies were included. We systematically extracted and categorised outcome reporting. Six randomised trials and 94 observational studies, reporting data from 20,071 maternal participants and 3,199 children, were included. Six different treatments were evaluated. Included studies reported sixty-two different outcomes, including 10 fetal, 28 neonatal, 6 early childhood and 18 maternal outcomes. The outcomes were inconsistently reported across trials. For example, when considering offspring mortality, 31 studies (31%) reported live birth, 31 studies (31%) reported intrauterine death, 49 studies (49%) reported neonatal mortality, and 17 studies (17%) reported perinatal mortality. Four studies (4%) reported respiratory distress syndrome. Only 19 (19%) of studies were designed for long-term follow-up and 11 of these studies (11%) reported cerebral palsy. Most studies evaluating treatments for TTTS, have often neglected to report clinically important outcomes, especially neonatal morbidity outcomes. Most studies are not designed for long-term follow-up. The development of a core outcome set could help standardised outcome collection and reporting in Twin-Twin Transfusion syndrome studies. This article is protected by copyright. All rights reserved.

  12. Reducing Postpartum Weight Retention and Improving Breastfeeding Outcomes in Overweight Women: A Pilot Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Julia Martin

    2015-02-01

    Full Text Available Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2 and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25–35 kg/m2 (n = 36 were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

  13. Alzheimer Disease Biomarkers as Outcome Measures for Clinical Trials in MCI.

    Science.gov (United States)

    Caroli, Anna; Prestia, Annapaola; Wade, Sara; Chen, Kewei; Ayutyanont, Napatkamon; Landau, Susan M; Madison, Cindee M; Haense, Cathleen; Herholz, Karl; Reiman, Eric M; Jagust, William J; Frisoni, Giovanni B

    2015-01-01

    The aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI). Magnetic resonance imaging, F-18 fluorodeoxyglucose positron emission tomography markers, and Alzheimer's Disease Assessment Scale-cognitive subscale were compared in terms of effect size and statistical power over different follow-up periods in 2 MCI groups, selected from Alzheimer's Disease Neuroimaging Initiative data set based on cerebrospinal fluid (abnormal cerebrospinal fluid Aβ1-42 concentration-ABETA+) or magnetic resonance imaging evidence of Alzheimer disease (positivity to hippocampal atrophy-HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms. Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency. These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials.

  14. Incidence of the Bertillon and Gompertz effects on the outcome of clinical trials

    Science.gov (United States)

    Roehner, Bertrand M.

    2014-11-01

    The accounts of medical trials provide very detailed information about the patients’ health conditions. On the contrary, almost no vital data such as marital status or age distribution are usually given. Yet, some of these factors can have a notable impact on the overall death rate, thereby changing the outcome and conclusions of the trial. This paper focuses on two of these variables. The first is marital status; its effect on life expectancy (which will be referred to as the Bertillon effect) may double death rates in all age intervals. The second variable is the age distribution of the oldest patients. Because of the exponential nature of Gompertz’s law changes in the distribution of ages in the oldest age group can have dramatic consequences on the overall number of deaths. One should recall that the death rate at the age of 82 is 40 times higher than at the age of 37. It will be seen that randomization alone can hardly take care of these problems. Appropriate remedies are easy to formulate however. First, the marital status of patients as well as the age distribution of those over 65 should be documented for both study groups. Then, thanks to these data and based on the Bertillon and Gompertz laws, it will become possible to perform appropriate corrections. Such corrections will notably improve the reliability and accuracy of the conclusions, especially in trials which include a large proportion of elderly subjects.

  15. Predictors of Adverse Cosmetic Outcome in the RAPID Trial: An Exploratory Analysis

    International Nuclear Information System (INIS)

    Peterson, David; Truong, Pauline T.; Parpia, Sameer; Olivotto, Ivo A.; Berrang, Tanya; Kim, Do-Hoon; Kong, Iwa; Germain, Isabelle; Nichol, Alan; Akra, Mohamed; Roy, Isabelle; Reed, Melanie; Fyles, Anthony; Trotter, Theresa; Perera, Francisco; Balkwill, Susan; Lavertu, Sophie; Elliott, Elizabeth

    2015-01-01

    Purpose: To evaluate factors associated with adverse cosmesis outcome in breast cancer patients randomized to accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy or whole-breast irradiation in the RAPID (Randomized Trial of Accelerated Partial Breast Irradiation) trial. Methods and Materials: Subjects were trial participants with nurse-assessed global cosmetic scores at baseline and at 3 years. Adverse cosmesis was defined as a score of fair or poor. Cosmetic deterioration was defined as any adverse change in score from baseline to 3 years. The analysis is based on data from the previously reported interim analysis. Logistic regression models were used to assess the association of risk factors for these outcomes among all patients and those treated with APBI only. Results: Clinicopathologic characteristics were similar between subjects randomized to APBI (n=569) or whole-breast irradiation (n=539). For all subjects, factors associated with adverse cosmesis at 3 years were older age, central/inner tumor location, breast infection, smoking, seroma volume, breast volume, and use of APBI; factors associated with cosmetic deterioration were smoking, seroma volume, and use of APBI (P<.05). For APBI subjects, tumor location, smoking, age, and seroma volume were associated with adverse cosmesis (P<.05), and smoking was associated with cosmetic deterioration (P=.02). An independent association between the V95/whole-breast volume ratio and adverse cosmesis (P=.28) or cosmetic deterioration (P=.07) was not detected. On further exploration a V95/whole-breast volume ratio <0.15 was associated with a lower risk of cosmetic deterioration (p=.04), but this accounted for only 11% of patients. Conclusion: In the RAPID trial, a number of patient tumor and treatment-related factors, including the use of APBI, were associated with adverse cosmesis and cosmetic deterioration. For patients treated with APBI alone, the high-dose treatment

  16. Predictors of Adverse Cosmetic Outcome in the RAPID Trial: An Exploratory Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Peterson, David; Truong, Pauline T. [Vancouver Island Centre, British Columbia Cancer Agency, Victoria, British Columbia (Canada); Parpia, Sameer [Ontario Clinical Oncology Group, McMaster University, Hamilton, Ontario (Canada); Olivotto, Ivo A. [Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta (Canada); Berrang, Tanya [Vancouver Island Centre, British Columbia Cancer Agency, Victoria, British Columbia (Canada); Kim, Do-Hoon; Kong, Iwa [Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, Ontario (Canada); Germain, Isabelle [Centre Hospitalier Universitaire de Québec, Pavillon Hôtel-Dieu de Quebec, Quebec City, Québec (Canada); Nichol, Alan [Vancouver Centre, British Columbia Cancer Agency, Vancouver, British Columbia (Canada); Akra, Mohamed [CancerCare Manitoba, Winnipeg, Manitoba (Canada); Roy, Isabelle [Centre intégré de cancérologie de Laval, Laval, Québec (Canada); Reed, Melanie [Center for the Southern Interior, British Columbia Cancer Agency, Kelowna, British Columbia (Canada); Fyles, Anthony [University Health Network, Princess Margaret Hospital, Toronto, Ontario (Canada); Trotter, Theresa [Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta (Canada); Perera, Francisco [London Regional Cancer Centre, London, Ontario (Canada); Balkwill, Susan [Fraser Valley Centre, British Columbia Cancer Agency, Surrey, British Columbia (Canada); Lavertu, Sophie [Centre Hospitalier de l' Université de Montréal, Hôpital Notre-Dame, Montreal, Québec (Canada); Elliott, Elizabeth [Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, Ontario (Canada); and others

    2015-04-01

    Purpose: To evaluate factors associated with adverse cosmesis outcome in breast cancer patients randomized to accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy or whole-breast irradiation in the RAPID (Randomized Trial of Accelerated Partial Breast Irradiation) trial. Methods and Materials: Subjects were trial participants with nurse-assessed global cosmetic scores at baseline and at 3 years. Adverse cosmesis was defined as a score of fair or poor. Cosmetic deterioration was defined as any adverse change in score from baseline to 3 years. The analysis is based on data from the previously reported interim analysis. Logistic regression models were used to assess the association of risk factors for these outcomes among all patients and those treated with APBI only. Results: Clinicopathologic characteristics were similar between subjects randomized to APBI (n=569) or whole-breast irradiation (n=539). For all subjects, factors associated with adverse cosmesis at 3 years were older age, central/inner tumor location, breast infection, smoking, seroma volume, breast volume, and use of APBI; factors associated with cosmetic deterioration were smoking, seroma volume, and use of APBI (P<.05). For APBI subjects, tumor location, smoking, age, and seroma volume were associated with adverse cosmesis (P<.05), and smoking was associated with cosmetic deterioration (P=.02). An independent association between the V95/whole-breast volume ratio and adverse cosmesis (P=.28) or cosmetic deterioration (P=.07) was not detected. On further exploration a V95/whole-breast volume ratio <0.15 was associated with a lower risk of cosmetic deterioration (p=.04), but this accounted for only 11% of patients. Conclusion: In the RAPID trial, a number of patient tumor and treatment-related factors, including the use of APBI, were associated with adverse cosmesis and cosmetic deterioration. For patients treated with APBI alone, the high-dose treatment

  17. Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N. Venkatesh; Krishnan, K. Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; O’Brien, Kieran S.; Ray, Kathryn J.; McLeod, Stephen D.; Porco, Travis C.; Lietman, Thomas M.; Acharya, Nisha R.; Keenan, Jeremy D.

    2016-01-01

    IMPORTANCE Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. OBJECTIVE To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. DESIGN, SETTING, AND PARTICIPANTS Secondary analysis (performed October 11–25, 2014) of a double-masked, multicenter, randomized, active comparator–controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3–1.3). INTERVENTIONS Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. MAIN OUTCOMES AND MEASURES Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. RESULTS A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1–8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle–corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9–14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, −3.9 to 6.9]; P

  18. Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Schuster, Corina; Maunz, Gerd; Lutz, Karin; Kischka, Udo; Sturzenegger, Rolf; Ettlin, Thierry

    2011-10-01

    For early inpatient stroke rehabilitation, the effectiveness of amphetamine combined with physiotherapy varies across studies. To investigate whether the recovery of activities of daily living (ADL, primary outcome) and motor function (secondary outcome) can be improved by dexamphetamine added to physiotherapy. In a double-blind, placebo-controlled trial, 16 patients, from 918 who were screened, were randomized to the experimental group (EG, dexamphetamine + physiotherapy) or control group (CG, placebo + physiotherapy). Both groups received multidisciplinary inpatient rehabilitation. Dexamphetamine (10 mg oral) or placebo was administered 2 days per week before physiotherapy. ADL and motor function were measured using the Chedoke-McMaster Stroke Assessment (CMSA) twice during baseline, every week during the 5-week treatment period, and at follow-up 1 week, 6 months, and 12 months after intervention. The majority of ineligible patients had too little paresis, were on anticoagulants, or had a stroke >60 days prior to entry. Participants (EG, n = 7, age 70.3 ± 10 years, 5 women, 37.9 ± 9 days after stroke; CG, n = 9, age 65.2 ± 17 years, 3 women, 40.3 ± 9 days after stroke) did not differ at baseline except for the leg subscale. Analysis of variance from baseline to 1 week follow-up revealed significant improvements in favor of EG for subscales ADL (P = .023) and arm function (P = .020) at end of treatment. No adverse events were detected. In this small trial that was based on prior positive trials, significant gains in ADL and arm function suggest that the dose and timing of dexamphetamine can augment physiotherapy. Effect size calculation suggests inclusion of at least 25 patients per group in future studies.

  19. Cognitive-Behavioral Therapy for Chronic Cardiopulmonary Conditions: Preliminary Outcomes From an Open Trial

    Science.gov (United States)

    Stanley, Melinda A.; Deswal, Anita; Hanania, Nicola A.; Phillips, Laura L.; Kunik, Mark E.

    2010-01-01

    Objective: To examine the effectiveness of tailored cognitive-behavioral therapy (CBT) for veterans with congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) with comorbid symptoms of depression and/or anxiety. Method: Twenty-three veterans with CHF and/or COPD, identified from electronic medical records at a large Veterans Affairs medical center, with clinically significant symptoms of depression (Beck Depression Inventory-II [BDI-II] score ≥ 14) and/or anxiety (State Trait Anxiety Inventory [STAI] score ≥ 40) were enrolled in an open trial from August 2007 to August 2008. All patients received CBT delivered mostly by advanced psychology trainees that consisted of 6 weekly sessions and 3 telephone booster calls. The intervention expanded traditional CBT techniques in order to address patients’ emotional and physical health difficulties using in-person and telephone-based sessions. Outcomes examined depression (BDI-II), anxiety (STAI), and disease-specific quality of life (Chronic Respiratory Questionnaire [CRQ] and Kansas City Cardiomyopathy Questionnaire [KCCQ]) postintervention and at 3-month follow-up. Results: Symptoms of depression (effect size = 0.97) and anxiety (effect size = 0.57) were improved at 8 weeks and maintained at 3-month follow-up. Physical disease outcomes were also improved for COPD (CRQ mastery effect size = 0.65, CRQ fatigue effect size = 0.75) and CHF (KCCQ overall summary score effect size = 1.19). Conclusions: Modifications to traditional CBT approaches have the potential to address the emotional and physical health challenges associated with complex cardiopulmonary patients. The brief duration and use of telephone-based sessions increase the opportunity for CBT interventions to be integrated within primary care settings, but additional trials are needed. Trial Registration: clinicaltrials.gov Identifier: NCT00727155 PMID:21085552

  20. Lactate versus pH levels in fetal scalp blood during labor--using the Lactate Scout System

    DEFF Research Database (Denmark)

    Lundin, Ingeborg Christina Rørbye; Perslev, Anette; Nickelsen, Carsten Nahne Amtoft

    2016-01-01

    OBJECTIVE: To assess if lactate measured with the Scout Lactate System is a reliable alternative to pH in intrapartum monitoring of the fetus. METHODS: A prospective study analyzing (1) the correlation between scalp lactate measured by the Scout Lactate System and the Automatic Blood Laboratory (...

  1. Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

    Science.gov (United States)

    Zhang, Sheng; Liang, Fei; Li, Wenfeng

    2017-11-01

    The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Near Earth Asteroid Scout: NASA's Solar Sail Mission to a NEA

    Science.gov (United States)

    Johnson, Les; Lockett, Tiffany

    2017-01-01

    NASA is developing a solar sail propulsion system for use on the Near Earth Asteroid (NEA) Scout reconnaissance mission and laying the groundwork for their use in future deep space science and exploration missions. Solar sails use sunlight to propel vehicles through space by reflecting solar photons from a large, mirror-like sail made of a lightweight, highly reflective material. This continuous photon pressure provides propellantless thrust, allowing for very high Delta V maneuvers on long-duration, deep space exploration. Since reflected light produces thrust, solar sails require no onboard propellant. The Near Earth Asteroid (NEA) Scout mission, funded by NASA's Advanced Exploration Systems Program and managed by NASA MSFC, will use the sail as primary propulsion allowing it to survey and image Asteroid 1991VG and, potentially, other NEA's of interest for possible future human exploration. NEA Scout uses a 6U cubesat (to be provided by NASA's Jet Propulsion Laboratory), an 86 m(exp. 2) solar sail and will weigh less than 12 kilograms. NEA Scout will be launched on the first flight of the Space Launch System in 2018. The solar sail for NEA Scout will be based on the technology developed and flown by the NASA NanoSail-D and The Planetary Society's Lightsail-A. Four approximately 7 m stainless steel booms wrapped on two spools (two overlapping booms per spool) will be motor deployed and pull the sail from its stowed volume. The sail material is an aluminized polyimide approximately 2.5 microns thick. As the technology matures, solar sails will increasingly be used to enable science and exploration missions that are currently impossible or prohibitively expensive using traditional chemical and electric propulsion systems. This paper will summarize the status of the NEA Scout mission and solar sail technology in general.

  3. Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study.

    Science.gov (United States)

    Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Marshman, Zoe; Benson, Philip; Colonio Salazar, Fiorella B; Fleming, Padhraig S

    2017-08-04

    Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved. The project has been registered on the Core Outcome Measures in Effectiveness Trials ( COMET ) website

  4. The effects of pilates on mental health outcomes: A meta-analysis of controlled trials.

    Science.gov (United States)

    Fleming, Karl M; Herring, Matthew P

    2018-04-01

    This meta-analysis estimated the population effect size for Pilates effects on mental health outcomes. Articles published prior to August 2017 were located with searches of Pubmed, Medline, Cinahl, SportDiscus, Science Direct, PsychINFO, Web of Science, and Cochrane Controlled Trial Register using combinations of: Pilates, Pilates method, mental health, anxiety, and depression. Eight English-language publications that included allocation to a Pilates intervention or non-active control and a measure of anxiety and/or depressive symptoms at baseline and after the Pilates intervention were selected. Participant and intervention characteristics, anxiety and depressive symptoms and other mental health outcomes, including feelings of energy and fatigue and quality of life, were extracted. Hedges' d effect sizes were computed, study quality was assessed, and random effects models estimated sampling error and population variance. Pilates resulted in significant, large, heterogeneous reductions in depressive (Δ = 1.27, 95%CI: 0.44, 2.09; z = 3.02, p ≤ 0.003; N = 6, n = 261) and anxiety symptoms (Δ = 1.29, 95%CI: 0.24, 2.33; z = 2.40, p ≤ 0.02; N = 5, n = 231) and feelings of fatigue (Δ = 0.93, 95%CI: 0.21, 1.66; z = 2.52, p ≤ 0.012; N = 3, n = 161), and increases in feelings of energy (Δ = 1.49, 95%CI: 0.67, 2.30; z = 3.57, p Pilates improves mental health outcomes. Rigorously designed randomized controlled trials, including those that compare Pilates to other empirically-supported therapies, are needed to better understand Pilates' clinical effectiveness and plausible mechanisms of effects. Copyright © 2018 Elsevier Ltd. All rights reserved.

  5. Use of continuous glucose monitoring as an outcome measure in clinical trials.

    Science.gov (United States)

    Beck, Roy W; Calhoun, Peter; Kollman, Craig

    2012-10-01

    Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years). Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; Pblood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

  6. Cluster randomized trial to evaluate the impact of team training on surgical outcomes.

    Science.gov (United States)

    Duclos, A; Peix, J L; Piriou, V; Occelli, P; Denis, A; Bourdy, S; Carty, M J; Gawande, A A; Debouck, F; Vacca, C; Lifante, J C; Colin, C

    2016-12-01

    The application of safety principles from the aviation industry to the operating room has offered hope in reducing surgical complications. This study aimed to assess the impact on major surgical complications of adding an aviation-based team training programme after checklist implementation. A prospective parallel-group cluster trial was undertaken between September 2011 and March 2013. Operating room teams from 31 hospitals were assigned randomly to participate in a team training programme focused on major concepts of crew resource management and checklist utilization. The primary outcome measure was the occurrence of any major adverse event, including death, during the hospital stay within the first 30 days after surgery. Using a difference-in-difference approach, the ratio of the odds ratios (ROR) was estimated to compare changes in surgical outcomes between intervention and control hospitals. Some 22 779 patients were enrolled, including 5934 before and 16 845 after team training implementation. The risk of major adverse events fell from 8·8 to 5·5 per cent in 16 intervention hospitals (adjusted odds ratio 0·57, 95 per cent c.i. 0·48 to 0·68; P trends revealed significant improvements among ten institutions, equally distributed across intervention and control hospitals. Surgical outcomes improved substantially, with no difference between trial arms. Successful implementation of an aviation-based team training programme appears to require modification and adaptation of its principles in the context of the the surgical milieu. Registration number: NCT01384474 (http://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

  7. BP, Cardiovascular Disease, and Death in the Folic Acid for Vascular Outcome Reduction in Transplantation Trial

    Science.gov (United States)

    John, Alin; Weir, Matthew R.; Smith, Stephen R.; Hunsicker, Lawrence; Kasiske, Bertram L.; Kusek, John W.; Bostom, Andrew; Ivanova, Anastasia; Levey, Andrew S.; Solomon, Scott; Pesavento, Todd; Weiner, Daniel E.

    2014-01-01

    The optimal BP level in kidney transplant recipients remains uncertain. This post hoc analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) trial cohort assessed associations of BP with a pooled cardiovascular disease (CVD) outcome and with all-cause mortality. In 3474 prevalent kidney transplant patients, mean age was 52±9 years, 63% were men, 76% were white, 20% had a history of CVD, 40% had a history of diabetes mellitus, and the median time since transplant was 4.1 years (25th to 75th percentiles, 1.7–7.4); mean systolic BP was 136±20 mmHg and mean diastolic BP was 79±12 mmHg. There were 497 CVD events and 406 deaths. After adjustment for demographic and transplant characteristics and CVD risk factors, each 20-mmHg increase in baseline systolic BP associated with a 32% increase in subsequent CVD risk (hazard ratio [HR], 1.32; 95% confidence interval [95% CI], 1.19 to 1.46) and a 13% increase in mortality risk (HR, 1.13; 95% CI, 1.01 to 1.27). Similarly, after adjustment, at diastolic BP levels70 mmHg, there was no significant relationship between diastolic BP and outcomes. Higher systolic BP strongly and independently associated with increased risk of CVD and all-cause mortality, without evidence of a J shape, whereas only lower levels of diastolic BP associated with increased risk of CVD and death in this trial. PMID:24627349

  8. Peer Coaches to Improve Diabetes Outcomes in Rural Alabama: A Cluster Randomized Trial.

    Science.gov (United States)

    Safford, Monika M; Andreae, Susan; Cherrington, Andrea L; Martin, Michelle Y; Halanych, Jewell; Lewis, Marquita; Patel, Ashruta; Johnson, Ethel; Clark, Debra; Gamboa, Christopher; Richman, Joshua S

    2015-08-01

    It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under-resourced areas such as the rural South. We examined the effect of an innovative peer-coaching intervention plus brief education vs brief education alone on diabetes outcomes. This was a community-engaged, cluster-randomized, controlled trial with primary care practices and their surrounding communities serving as clusters. The trial enrolled 424 participants, with 360 completing baseline and follow-up data collection (84.9% retention). The primary outcomes were change in glycated hemoglobin (HbA1c), systolic blood pressure (BP), low density lipoprotein cholesterol (LDL-C), body mass index (BMI), and quality of life, with diabetes distress and patient activation as secondary outcomes. Peer coaches were trained for 2 days in community settings; the training emphasized motivational interviewing skills, diabetes basics, and goal setting. All participants received a 1-hour diabetes education class and a personalized diabetes report card at baseline. Intervention arm participants were also paired with peer coaches; the protocol called for telephone interactions weekly for the first 8 weeks, then monthly for a total of 10 months. Due to real-world constraints, follow-up was protracted, and intervention effects varied over time. The analysis that included the 68% of participants followed up by 15 months showed only a significant increase in patient activation in the intervention group. The analysis that included all participants who eventually completed follow-up revealed that intervention arm participants had significant differences in changes in systolic BP (P = .047), BMI (P = .02), quality of life (P = .003), diabetes distress (P = .004), and patient activation (P = .03), but not in HbA1c (P = .14) or LDL-C (P = .97). Telephone-delivered peer coaching holds promise to improve health for individuals with diabetes living in under-resourced areas. © 2015

  9. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

    Science.gov (United States)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

    2017-12-01

    Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

  10. Social Talent Scouting: A New Opportunity for the Identification of Football Players?

    Directory of Open Access Journals (Sweden)

    Radicchi Elena

    2016-06-01

    Full Text Available This paper investigates the diffusion of digital technologies within the football talent scouting process. A qualitative exploration based on open discussions and unstructured interviews with professionals involved in the football system (coaches, scouts, players’ agents, etc. provides insights about how new technologies are used for recruiting athletes. The findings, which are mainly in the context of Italian football, indicate a cultural and generational gap in the use of new digital tools that creates a mismatch between young promising athletes (demand side and “senior” team professionals (supply side.

  11. Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement

    NARCIS (Netherlands)

    Spuls, P. I.; Gerbens, L. A. A.; Simpson, E.; Apfelbacher, C. J.; Chalmers, J. R.; Thomas, K. S.; Prinsen, C. A. C.; von Kobyletzki, L. B.; Singh, J. A.; Williams, H. C.; Schmitt, J.

    2017-01-01

    The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is

  12. Moderators of smoking cessation outcomes in a randomized-controlled trial of varenicline versus placebo.

    Science.gov (United States)

    Littlewood, Rae A; Claus, Eric D; Wilcox, Claire E; Mickey, Jessica; Arenella, Pamela B; Bryan, Angela D; Hutchison, Kent E

    2017-12-01

    Varenicline has gained a reputation as the optimal intervention for treatment resistant smokers, yet more than half of those who try it do not succeed. To better understand individual differences in the effectiveness of varenicline, this study evaluates the effectiveness of varenicline for smoking cessation in a double-blind, placebo-controlled, randomized clinical trial and examines the influence of psychological factors on treatment outcome. Two hundred five cigarette smokers interested in quitting were randomly assigned to 12 weeks of varenicline or placebo. Outcomes examined were CO-confirmed continuous abstinence for the past month, average number of cigarettes smoked per day, and 7-day point prevalence. Varenicline-treated participants were more likely than placebo to achieve continuous abstinence at the end of treatment (OR = 3.29; RR = 2.62), and 7-day point prevalence rates showed an effect of medication at each time point. Participants in both groups significantly reduced their smoking during the course of treatment and follow-up, and the medication by visit interaction was significant in the expected direction. Impulsivity and personality style emerged as moderators of the relationship between medication condition and treatment outcome. In addition to replicating efficacy results for varenicline versus placebo, the present study shows that the efficacy of pharmacotherapy is influenced by psychological factors. In an era where pharmacotherapy is often perceived as the "silver bullet," we are reminded that smoking cessation is a dynamic process and intervention must be adaptable to address individual differences.

  13. Filtration Markers, Cardiovascular Disease, Mortality, and Kidney Outcomes in Stable Kidney Transplant Recipients: The FAVORIT Trial.

    Science.gov (United States)

    Foster, M C; Weiner, D E; Bostom, A G; Carpenter, M A; Inker, L A; Jarolim, P; Joseph, A A; Kusek, J W; Pesavento, T; Pfeffer, M A; Rao, M; Solomon, S D; Levey, A S

    2017-09-01

    Cystatin C and beta-2-microglobulin (B2M) are filtration markers associated with adverse outcomes in nontransplant populations, sometimes with stronger associations than for creatinine. We evaluated associations of estimated glomerular filtration rate from cystatin C (eGFR cys ), B2M (eGFR B 2M ), and creatinine (eGFR cr ) with cardiovascular outcomes, mortality, and kidney failure in stable kidney transplant recipients using a case-cohort study nested within the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. A random subcohort was selected (N = 508; mean age 51.6 years, median transplant vintage 4 years, 38% women, 23.6% nonwhite race) with enrichment for cardiovascular events (N = 306; 54 within the subcohort), mortality (N = 208; 68 within the subcohort), and kidney failure (N = 208; 52 within the subcohort). Mean eGFR cr , eGFR cys , and eGFR B 2M were 46.0, 43.8, and 48.8 mL/min/1.73m 2 , respectively. After multivariable adjustment, hazard ratios for eGFR cys and eGFR B 2M mortality; and 9.49 (4.28-21.00) and 15.53 (6.99-34.51; both p mortality, and kidney failure in stable kidney transplant recipients. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

  14. Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy: A systematic review.

    Science.gov (United States)

    Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen; Dodd, Jodie M; Guelfi, Kym; Teede, Helena; Surita, Fernanda; Jensen, Dorte M; Geiker, Nina R W; Astrup, Arne; Yeo, SeonAe; Kinnunen, Tarja I; Stafne, Signe N; Cecatti, Jose G; Bogaerts, Annick; Hauner, Hans; Mol, Ben W; Scudeller, Tânia T; Vinter, Christina A; Renault, Kristina M; Devlieger, Roland; Thangaratinam, Shakila; Khan, Khalid S

    2017-07-01

    Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. We searched major databases without language restrictions for randomized controlled trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60.6%, 40/66), were the commonly reported 'critically important' outcomes. Gestational weight gain (84.5%, 56/66) and birth weight (87.9%, 58/66) were reported in most papers, although not considered critically important. The median quality of reporting was 0.60 (interquartile range 0.25, 0.83) for a maximum score of one. Study and journal characteristics did not affect quality. Many studies on lifestyle interventions in pregnancy do not report critically important outcomes, highlighting the need for core outcome set development. © 2017 Japan Society of Obstetrics and Gynecology.

  15. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children.

    Directory of Open Access Journals (Sweden)

    Ian Sinha

    2008-04-01

    Full Text Available In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children.We searched Cochrane databases (no date restrictions in December 2006; and MEDLINE (1950 to 2006, CINAHL (1982 to 2006, and SCOPUS (1966 to 2006 in January 2007 for studies of the selection of outcomes for use in clinical trials in children. We also asked a group of experts in paediatric clinical research to refer us to any other relevant studies. From these articles we extracted data on the clinical condition of interest, description of the method used to select outcomes, the people involved in the selection process, the outcomes selected, and limitations of the method as defined by the authors. The literature search identified 8,889 potentially relevant abstracts. Of these, 70 were retrieved, and 25 were included in the review. These studies described the work of 13 collaborations representing various paediatric specialties including critical care, gastroenterology, haematology, psychiatry, neurology, respiratory paediatrics, rheumatology, neonatal medicine, and dentistry. Two groups utilised the Delphi technique, one used the nominal group technique, and one used both methods to reach a consensus about which outcomes should be measured in clinical trials. Other groups used semistructured discussion, and one group used a questionnaire-based survey. The collaborations involved clinical experts, research experts, and industry representatives. Three groups involved parents of children affected by the particular condition.Very few studies address the appropriate choice of outcomes for clinical research

  16. Periodontal treatment during pregnancy and birth outcomes: a meta-analysis of randomised trials.

    Science.gov (United States)

    George, Ajesh; Shamim, Simin; Johnson, Maree; Ajwani, Shilpi; Bhole, Sameer; Blinkhorn, Anthony; Ellis, Sharon; Andrews, Karen

    2011-06-01

    The objective of this review was to conduct a meta-analysis of all up-to-date randomised control trials to determine whether periodontal treatment during pregnancy has the potential of reducing preterm birth and low birth weight incidence. Bibliographic databases MEDLINE (1966-present), EMBASE (1980-present), CINAHL (1982-present) and the Cochrane library up to and including 2010 Issue 10 were searched. The reference list of included studies and reviews were also searched for additional literature. Eligible studies were, published and ongoing randomised control trials that compared pregnancy outcomes for pregnant women who received periodontal treatment during the prenatal period. Two of the investigators independently assessed the studies and then extracted and summarised data from eligible trials. Extracted data were entered into Review Manager software and analysed. A total of 5645 pregnant women participated in the 10 eligible trials. Meta-analysis found that periodontal treatment significantly lowered preterm birth (odd ratio 0.65; 95% confidence interval, 0.45-0.93; P = 0.02) and low birth weight (odd ratio 0.53; 95% confidence interval, 0.31-0.92; P = 0.02) rates while no significant difference was found for spontaneous abortion/stillbirth (odd ratio 0.71; 95% confidence interval, 0.43-1.16; P = 0.17). Moderate heterogeneity was observed among the studies for preterm birth and low birth weight. Subgroup analysis showed significant effect of periodontal treatment in pregnant women with low rate of previous preterm birth/low birth weight (odd ratio 0.35; 95% confidence interval, 017-0.70; P = 0.003) and less severe periodontal disease (odd ratio 0.49; confidence interval, 028-0.87; P = 0.01) as defined by probing depth. The cumulative evidence suggests that periodontal treatment during pregnancy may reduce preterm birth and low birth weight incidence. However, these findings need to be further validated through larger more targeted randomised control trials.

  17. Development of outcome measures for large-vessel vasculitis for use in clinical trials: opportunities, challenges, and research agenda.

    Science.gov (United States)

    Direskeneli, Haner; Aydin, Sibel Z; Kermani, Tanaz A; Matteson, Eric L; Boers, Maarten; Herlyn, Karen; Luqmani, Raashid A; Neogi, Tuhina; Seo, Philip; Suppiah, Ravi; Tomasson, Gunnar; Merkel, Peter A

    2011-07-01

    Giant cell (GCA) and Takayasu's arteritis (TAK) are 2 forms of large-vessel vasculitis (LVV) that involve the aorta and its major branches. GCA has a predilection for the cranial branches, while TAK tends to affect the extracranial branches. Both disorders may also cause nonspecific constitutional symptoms. Although some clinical features are more common in one or the other disorder and the ages of initial presentation differ substantially, there is enough clinical and histopathologic overlap between these disorders that some investigators suggest GCA and TAK may be 2 processes within the spectrum of a single disease. There have been few randomized therapeutic trials completed in GCA, and none in TAK. The lack of therapeutic trials in LVV is only partially explained by the rarity of these diseases. It is likely that the lack of well validated outcome measures for LVV and uncertainties regarding trial design contribute to the paucity of trials for these diseases. An initiative to develop a core set of outcome measures for use in clinical trials of LVV was launched by the international OMERACT Vasculitis Working Group in 2009 and subsequently endorsed by the OMERACT community at the OMERACT 10 meeting. Aims of this initiative include: (1) to review the literature and existing data related to outcome assessments in LVV; (2) to obtain the opinion of experts and patients on disease content; and (3) to formulate a research agenda to facilitate a more data-based approach to outcomes development.

  18. Improving the outcomes of children affected by parental substance abuse: a review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Calhoun S

    2015-01-01

    Full Text Available Stacy Calhoun,1,2 Emma Conner,2 Melodi Miller,3 Nena Messina1 1UCLA Integrated Substance Abuse Programs, Los Angeles, CA, USA; 2Department of Criminology, Law and Society, University of California, Irvine, CA, USA; 3Social Solutions International, Inc., Silver Spring, MD, USA Abstract: Substance abuse is a major public health concern that impacts not just the user but also the user's family. The effect that parental substance abuse has on children has been given substantial attention over the years. Findings from the literature suggest that children of substance-abusing parents have a high risk of developing physical and mental health and behavioral problems. A number of intervention programs have been developed for parents who have a substance abuse problem. There have also been a number of interventions that have been developed for children who have at least one parent with a substance abuse problem. However, it remains unclear how we can best mitigate the negative effects that parental substance abuse has on children due to the scarcity of evaluations that utilize rigorous methodologies such as experimental designs. The purpose of this study is to review randomized controlled trials of intervention programs targeting parents with substance abuse problems and/or children with at least one parent with a substance abuse problem in order to identify programs that show some promise in improving the behavioral and mental health outcomes of children affected by parental substance abuse. Four randomized controlled trials that met our eligibility criteria were identified using major literature search engines. The findings from this review suggest that interventions that focus on improving parenting practices and family functioning may be effective in reducing problems in children affected by parental substance abuse. However, further research utilizing rigorous methodologies are needed in order to identify other successful interventions that can

  19. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    Science.gov (United States)

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  20. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

    2017-06-01

    To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

  1. The effect of variation in donor platelet function on transfusion outcome: a semirandomized controlled trial.

    Science.gov (United States)

    Kelly, Anne M; Garner, Stephen F; Foukaneli, Theodora; Godec, Thomas R; Herbert, Nina; Kahan, Brennan C; Deary, Alison; Bakrania, Lekha; Llewelyn, Charlotte; Ouwehand, Willem H; Williamson, Lorna M; Cardigan, Rebecca A

    2017-07-13

    The effect of variation in platelet function in platelet donors on patient outcome following platelet transfusion is unknown. This trial assessed the hypothesis that platelets collected from donors with highly responsive platelets to agonists in vitro assessed by flow cytometry (high-responder donors) are cleared more quickly from the circulation than those from low-responder donors, resulting in lower platelet count increments following transfusion. This parallel group, semirandomized double-blinded trial was conducted in a single center in the United Kingdom. Eligible patients were those 16 or older with thrombocytopenia secondary to bone marrow failure, requiring prophylactic platelet transfusion. Patients were randomly assigned to receive a platelet donation from a high- or low-responder donor when both were available, or when only 1 type of platelet was available, patients received that. Participants, investigators, and those assessing outcomes were masked to group assignment. The primary end point was the platelet count increment 10 to 90 minutes following transfusion. Analysis was by intention to treat. Fifty-one patients were assigned to receive platelets from low-responder donors, and 49 from high-responder donors (47 of which were randomized and 53 nonrandomized). There was no significant difference in platelet count increment 10 to 90 minutes following transfusion in patients receiving platelets from high-responder (mean, 21.0 × 10 9 /L; 95% confidence interval [CI], 4.9-37.2) or low-responder (mean, 23.3 × 10 9 /L; 95% CI, 7.8-38.9) donors (mean difference, 2.3; 95% CI, -1.1 to 5.7; P = .18). These results support the current policy of not selecting platelet donors on the basis of platelet function for prophylactic platelet transfusion. © 2017 by The American Society of Hematology.

  2. Treatment outcome of advanced pancreatic cancer patients who are ineligible for a clinical trial

    Directory of Open Access Journals (Sweden)

    Ueda A

    2013-05-01

    Full Text Available Akira Ueda, Ayumu Hosokawa, Kohei Ogawa, Hiroki Yoshita, Takayuki Ando, Shinya Kajiura, Haruka Fujinami, Kengo Kawai, Jun Nishikawa, Kazuto Tajiri, Masami Minemura, Toshiro SugiyamaDepartment of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, JapanObjective: The aim of this study was to evaluate the outcome of patients with advanced pancreatic cancer in clinical practice, and assess whether chemotherapy provided a clinical benefit for patients who did not meet the eligibility criteria of the clinical trial.Methods: We retrospectively analyzed the medical records of 75 patients who received first-line chemotherapy for pancreatic cancer between April 2006 and September 2011. Patients were treated with gemcitabine (GEM alone, S-1 (tegafur, gimeracil, and oteracil potassium alone, or GEM plus S-1. Patients were divided into the clinical trial eligible group (arm eligible or the ineligible group (arm ineligible. We evaluated the efficacy and the safety of the chemotherapy.Results: A total of 23 patients out of 75 (31% belonged to the ineligible group, for the following reasons: 20 patients had poor performance status, eight had massive ascites, one had synchronous malignancy, and one had icterus. The median progression-free survival (PFS was 3.5 months, and the median overall survival (OS was 6.7 months in all patients. In arm eligible, median PFS was 4.5 months, and median OS was 10.5 months. In arm ineligible, median PFS was 1.1 months, and median OS was 2.9 months.Conclusion: The outcome of the patients who did not meet the eligibility criteria was very poor. It is important to select the patients that could benefit from either chemotherapy or optimal supportive care.Keywords: gemcitabine, S-1, clinical practice

  3. 'Alzheimer's Progression Score': Development of a Biomarker Summary Outcome for AD Prevention Trials.

    Science.gov (United States)

    Leoutsakos, J-M; Gross, A L; Jones, R N; Albert, M S; Breitner, J C S

    2016-01-01

    pre-clinical AD progression, and holds promise as an outcome for AD prevention trials.

  4. Outcome of trial of scar in patients with previous caesarean section

    International Nuclear Information System (INIS)

    Khan, B.; Bashir, R.; Khan, W.

    2016-01-01

    Medical evidence indicates that 60-80% of women can achieve vaginal delivery after a previous lower segment caesarean section. Proper selection of patients for trial of scar and vigilant monitoring during labour will achieve successful maternal and perinatal outcome. The objective of our study is to establish the fact that vaginal delivery after one caesarean section has a high success rate in patients with previous one caesarean section for non-recurrent cause. Methods: The study was conducted in Ayub Teaching Abbottabad, Gynae-B Unit. All labouring patients, during the study period of five years, with previous one caesarean section and between 37 weeks to 41 weeks of gestation for a non-recurrent cause were included in the study. Data was recorded on special proforma designed for the purpose. Patients who had previous classical caesarean section, more than one caesarean section, and previous caesarean section with severe wound infection, transverse lie and placenta previa in present pregnancy were excluded. Foetal macrosomia (wt>4 kg) and severe IUGR with compromised blood flow on Doppler in present pregnancy were also not considered suitable for the study. Patients who had any absolute contraindication for vaginal delivery were also excluded. Results: There were 12505 deliveries during the study period. Total vaginal deliveries were 8790 and total caesarean sections were 3715. Caesarean section rate was 29.7%. Out of these 8790 patients, 764 patients were given a trial of scar and 535 patients delivered successfully vaginally (70%). Women who presented with spontaneous onset of labour were more likely to deliver vaginally (74.8%) as compared to induction group (27.1%). Conclusion: Trial of vaginal birth after caesarean (VBAC) in selected cases has great importance in the present era of the rising rate of primary caesarean section. (author)

  5. Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia.

    LENUS (Irish Health Repository)

    Niemeyer, Charlotte M

    2015-01-01

    Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.

  6. Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  7. Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

    Science.gov (United States)

    Zhou, Ming; Tang, Qi; Lang, Lixin; Xing, Jun; Tatsuoka, Kay

    2018-04-17

    In clinical research and development, interim monitoring is critical for better decision-making and minimizing the risk of exposing patients to possible ineffective therapies. For interim futility or efficacy monitoring, predictive probability methods are widely adopted in practice. Those methods have been well studied for univariate variables. However, for longitudinal studies, predictive probability methods using univariate information from only completers may not be most efficient, and data from on-going subjects can be utilized to improve efficiency. On the other hand, leveraging information from on-going subjects could allow an interim analysis to be potentially conducted once a sufficient number of subjects reach an earlier time point. For longitudinal outcomes, we derive closed-form formulas for predictive probabilities, including Bayesian predictive probability, predictive power, and conditional power and also give closed-form solutions for predictive probability of success in a future trial and the predictive probability of success of the best dose. When predictive probabilities are used for interim monitoring, we study their distributions and discuss their analytical cutoff values or stopping boundaries that have desired operating characteristics. We show that predictive probabilities utilizing all longitudinal information are more efficient for interim monitoring than that using information from completers only. To illustrate their practical application for longitudinal data, we analyze 2 real data examples from clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.

  8. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  9. Citizenship and Children's Identity in "The Wonderful Adventures of Nils" and "Scouting for Boys"

    Science.gov (United States)

    Sundmark, Bjorn

    2009-01-01

    "The Wonderful Adventures of Nils" (1906-1907) by Selma Lagerlof and "Scouting for Boys" (1908) by Robert Baden-Powell are characteristic of their time and their respective national and cultural contexts--the Swedish nation state of the early twentieth century and the British Empire. Taking its cue from recent theories on…

  10. Implications of Boy Scout group use of public lands for natural resource managers: a regional comparison

    Science.gov (United States)

    Gail A. Vander Stoep

    1992-01-01

    Resource managers can apply group-specific rather than generic communications and management strategies to different public land user groups. This study compares use patterns of one user group, Boy Scout troops, from two regions of the United States. It identifies their public land use patterns, activities, needs, and motivations. Results can be used by resource...

  11. 76 FR 71564 - ScanScout, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Science.gov (United States)

    2011-11-18

    ... behavioral advertising, the practice of collecting and storing information about consumers' online activities... behavioral advertising. ScanScout's privacy policy stated that by changing their browser settings, consumers... data for online behavioral advertising. First, within thirty (30) days after service of the proposed...

  12. The Project Towards No Drug Abuse (TND) dissemination trial: implementation fidelity and immediate outcomes.

    Science.gov (United States)

    Rohrbach, Louise Ann; Gunning, Melissa; Sun, Ping; Sussman, Steve

    2010-03-01

    One of the important research issues in the emerging area of research on dissemination of prevention programs relates to the type and extent of training needed by program providers to prepare them to implement effective programs with fidelity. The present paper describes the immediate outcomes of a dissemination and implementation trial of Project Toward No Drug Abuse, an evidence-based prevention program for high school students. A total of 65 high schools in 14 school districts across the USA were recruited and randomly assigned to one of three experimental conditions: comprehensive implementation support for teachers, regular workshop training only, or standard care control. The comprehensive intervention was comprised of on-site coaching, web-based support, and technical assistance, in addition to the regular workshop. Students (n = 2,983) completed self-report surveys before and immediately after program implementation. Fidelity of implementation was assessed with a classroom observation procedure that focused on program process. Results indicated that relative to the controls, both intervention conditions produced effects on hypothesized program mediators, including greater gains in program-related knowledge; greater reductions in cigarette, marijuana and hard drug use intentions; and more positive changes in drug-related beliefs. There were stronger effects on implementation fidelity in the comprehensive, relative to the regular, training condition. However, seven of the ten immediate student outcome measures showed no significant differences between the two training conditions. The implications of these findings for dissemination research and practice are discussed.

  13. Outcomes of Video-Assisted Teaching for Latching in Postpartum Women: A Randomized Controlled Trial.

    Science.gov (United States)

    Sroiwatana, Suttikamon; Puapornpong, Pawin

    2018-04-25

    Latching is an important process of breastfeeding and should be taught and practiced by the postpartum mother. The objective is to compare latching outcomes between video-assisted and routine teaching methods among postpartum women. A randomized controlled trial was conducted. Postpartum women who had deliveries without complications were randomized into two groups: 14 cases in the video-assisted teaching group and 14 cases in a routine teaching group. In the first group, the mothers were taught breastfeeding benefits, latching methods, and breastfeeding positions and practiced breastfeeding in a controlled setting for a 30-minute period and watched a 6-minute video with consistent content. In the second group, the mothers were taught a normal 30-minute period and then practiced breastfeeding. In both groups, Latching on, Audible swallowing, the Type of nipples, Comfort, and Help (LATCH) scores were assessed at 24-32 and 48-56 hours after the breastfeeding teaching modals. Demographic data and LATCH scores were collected and analyzed. There were no statistically significant differences in the mothers' ages, occupations, marital status, religion, education, income, infants' gestational age, body mass index, nipple length, route of delivery, and time to first latching between the video-assisted and routine breastfeeding teaching groups. First and second LATCH score assessments had shown no significant differences between both breastfeeding teaching groups. The video-assisted breastfeeding teaching did not improve latching outcomes when it was compared with routine teaching.

  14. A randomized controlled trial of prison-initiated buprenorphine: prison outcomes and community treatment entry.

    Science.gov (United States)

    Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; Fitzgerald, Terrence T; O'Grady, Kevin E; Vocci, Frank J

    2014-09-01

    Buprenorphine is a promising treatment for heroin addiction. However, little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant, the relative effectiveness of the post-release setting in which it is provided, and gender differences in treatment outcome in this population. This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration. A total of 211 participants with 3-9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition (received buprenorphine vs. counseling only) and Post-release Service Setting (at an opioid treatment center vs. a community health center). Outcome measures were: entered prison treatment; completed prison treatment; and entered community treatment 10 days post-release. There was a significant main effect (p=.006) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition (99.0% vs. 80.4%). Regarding completing prison treatment, the only significant effect was Gender, with women significantly (pPrison buprenorphine Treatment Condition (47.5% vs. 33.7%). Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry. However, concerns remain with in-prison treatment termination due to attempted diversion of medication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. Delivery mode and neonatal outcome after a trial of external cephalic version (ECV): a prospective trial of vaginal breech versus cephalic delivery.

    Science.gov (United States)

    Reinhard, Joscha; Sänger, Nicole; Hanker, Lars; Reichenbach, Lena; Yuan, Juping; Herrmann, Eva; Louwen, Frank

    2013-04-01

    To examine the delivery mode and neonatal outcome after a trial of external cephalic version (ECV) procedures. This is an interim analysis of an ongoing larger prospective off-centre randomised trial, which compares a clinical hypnosis intervention against neuro-linguistic programming (NLP) of women with a singleton breech foetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. Main outcome measures were delivery mode and neonatal outcome. On the same day after the ECV procedure two patients (2 %), who had unsuccessful ECVs, had Caesarean sections (one due to vaginal bleeding and one due to pathological CTG). After the ECV procedure 40.4 % of women had cephalic presentation (n = 38) and 58.5 % (n = 55) remained breech presentation. One patient remained transverse presentation (n = 1; 1.1 %). Vaginal delivery was observed by 73.7 % of cephalic presentation (n = 28), whereas 26.3 % (n = 10) had in-labour Caesarean sections. Of those, who selected a trial of vaginal breech delivery, 42.4 % (n = 14) delivered vaginally and 57.6 % (n = 19) delivered via Caesarean section. There is a statistically significant difference between the rate of vaginal birth between cephalic presentation and trial of vaginal breech delivery (p = 0.009), however, no difference in neonatal outcome was observed. ECV is a safe procedure and can reduce not only the rate of elective Caesarean sections due to breech presentation but also the rate of in-labour Caesarean sections even if a trial of vaginal breech delivery is attempted.

  16. Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article

    Directory of Open Access Journals (Sweden)

    Kayambu Geetha

    2011-10-01

    Full Text Available Abstract Background Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU. Methods/Design A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252 will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care. The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test. Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow. Discussion The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000808044

  17. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    Science.gov (United States)

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

  18. Web-Based Cognitive Remediation Improves Supported Employment Outcomes in Severe Mental Illness: Randomized Controlled Trial.

    Science.gov (United States)

    Harris, Anthony Wf; Kosic, Tanya; Xu, Jean; Walker, Chris; Gye, William; Redoblado Hodge, Antoinette

    2017-09-20

    Finding work is a top priority for most people; however, this goal remains out of reach for the majority of individuals with a severe mental illness (SMI) who remain on benefits or are unemployed. Supported employment (SE) programs aimed at returning people with a severe mental illness to work are successful; however, they still leave a significant number of people with severe mental illness unemployed. Cognitive deficits are commonly found in SMI and are a powerful predictor of poor outcome. Fortunately, these deficits are amenable to treatment with cognitive remediation therapy (CRT) that significantly improves cognition in SMI. CRT combined with SE significantly increases the likelihood of individuals with severe mental illness obtaining and staying in work. However, the availability of CRT is limited in many settings. The aim of this study was to examine whether Web-based CRT combined with a SE program can improve the rate return to work of people with severe mental illness. A total of 86 people with severe mental illness (mean age 39.6 years; male: n=55) who were unemployed and who had joined a SE program were randomized to either a Web-based CRT program (CogRem) or an Internet-based control condition (WebInfo). Primary outcome measured was hours worked over 6 months post treatment. At 6 months, those participants randomized to CogRem had worked significantly more hours (P=.01) and had earned significantly more money (P=.03) than those participants randomized to the WebInfo control condition. No change was observed in cognition. This study corroborates other work that has found a synergistic effect of combining CRT with a SE program and extends this to the use of Web-based CRT. The lack of any improvement in cognition obscures the mechanism by which an improved wage outcome for participants randomized to the active treatment was achieved. However, the study substantially lowers the barrier to the deployment of CRT with other psychosocial interventions for

  19. The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

    Directory of Open Access Journals (Sweden)

    Dunkley David

    2008-09-01

    Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will

  20. The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

    Science.gov (United States)

    Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

    2008-01-01

    Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues) in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues) intervention or to an attention control (Care) condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will provide important information

  1. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

    Directory of Open Access Journals (Sweden)

    Soyeon Cheon

    2018-01-01

    Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

  2. 'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO Data in Trials to Inform Clinical Practice. A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Angus G K McNair

    Full Text Available The CONSORT extension for patient reported outcomes (PROs aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30% and 6 (16% combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14% and 1 (7% primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73% and 3 (20% achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2.It is recommended that single papers, with detailed PRO rationale and integrated PRO and

  3. Core outcome measurement instruments for clinical trials in nonspecific low back pain

    Science.gov (United States)

    Chiarotto, Alessandro; Boers, Maarten; Deyo, Richard A.; Buchbinder, Rachelle; Corbin, Terry P.; Costa, Leonardo O.P.; Foster, Nadine E.; Grotle, Margreth; Koes, Bart W.; Kovacs, Francisco M.; Lin, C.-W. Christine; Maher, Chris G.; Pearson, Adam M.; Peul, Wilco C.; Schoene, Mark L.; Turk, Dennis C.; van Tulder, Maurits W.; Terwee, Caroline B.; Ostelo, Raymond W.

    2018-01-01

    Abstract To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments. PMID:29194127

  4. The effects of vitamin D supplementation on maternal and neonatal outcome: A randomized clinical trial

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    Mahdieh Mojibian

    2015-11-01

    Full Text Available Background: Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes. Objective: This randomized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes (GDM, gestational hypertension, preeclampsia and preterm labor, vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily. Materials and Methods: 500 women with gestational age 12-16 weeks and serum 25 hydroxy vitamin D (25 (OH D less than 30 ng/ml randomly categorized in two groups. Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery. Maternal and Neonatal outcomes were assessed in two groups. Results: The incidence of GDM in group B was significantly lower than group A (6.7% versus 13.4% and odds ratio (95% Confidence interval was 0.46 (0.24-0.87 (P=0.01. The mean ± SD level of 25 (OH D at the time of delivery in mothers in group B was significantly higher than A (37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml, respectively (P=0.001. There were no differences in the incidence of preeclampsia, gestational hypertension, preterm labor, and low birth weight between two groups. The mean level of 25 (OH D in cord blood of group B was significantly higher than group A (37.9 ± 18 versus 29.7 ± 19ng/ml, respectively. Anthropometric measures between neonates were not significantly different. Conclusion: Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM.

  5. Acute bronchodilator responsiveness and health outcomes in COPD patients in the UPLIFT trial

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    Decramer Marc

    2011-01-01

    Full Text Available Abstract Background Debate continues as to whether acute bronchodilator responsiveness (BDR predicts long-term outcomes in COPD. Furthermore, there is no consensus on a threshold for BDR. Methods At baseline and during the 4-year Understanding Potential Long-term Improvements in Function with Tiotropium (UPLIFT® trial, patients had spirometry performed before and after administration of ipratropium bromide 80 mcg and albuterol 400 mcg. Patients were split according to three BDR thresholds: ≥12% + ≥200 mL above baseline (criterion A, ≥15% above baseline (criterion B; and ≥10% absolute increase in percent predicted FEV1 values (criterion C. Several outcomes (pre-dose spirometry, exacerbations, St. George's Respiratory Questionnaire [SGRQ] total score were assessed according to presence or absence of BDR in the treatment groups. Results 5783 of 5993 randomized patients had evaluable pre- and post-bronchodilator spirometry at baseline. Mean age (SD was 64 (8 years, with 75% men, mean post-bronchodilator FEV1 1.33 ± 0.44 L (47.6 ± 12.7% predicted and 30% current smokers. At baseline, 52%, 66%, and 39% of patients had acute BDR using criterion A, B, and C, respectively. The presence of BDR was variable at follow-up visits. Statistically significant improvements in spirometry and health outcomes occurred with tiotropium regardless of the baseline BDR or criterion used. Conclusions A large proportion of COPD patients demonstrate significant acute BDR. BDR in these patients is variable over time and differs according to the criterion used. BDR status at baseline does not predict long-term response to tiotropium. Assessment of acute BDR should not be used as a decision-making tool when prescribing tiotropium to patients with COPD.

  6. Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial.

    Science.gov (United States)

    Graham, Amanda L; Papandonatos, George D; Cha, Sarah; Erar, Bahar; Amato, Michael S

    2018-03-15

    Partial adherence in Internet smoking cessation interventions presents treatment and evaluation challenges. Increasing adherence may improve outcomes. To present smoking outcomes from an Internet randomized trial of two strategies to encourage adherence to tobacco dependence treatment components: (i) a social network (SN) strategy to integrate smokers into an online community and (ii) free nicotine replacement therapy (NRT). In addition to intent-to-treat analyses, we used novel statistical methods to distinguish the impact of treatment assignment from treatment utilization. A total of 5,290 current smokers on a cessation website (WEB) were randomized to WEB, WEB + SN, WEB + NRT, or WEB + SN + NRT. The main outcome was 30-day point prevalence abstinence at 3 and 9 months post-randomization. Adherence measures included self-reported medication use (meds), and website metrics of skills training (sk) and community use (comm). Inverse Probability of Retention Weighting and Inverse Probability of Treatment Weighting jointly addressed dropout and treatment selection. Propensity weights were used to calculate Average Treatment effects on the Treated. Treatment assignment analyses showed no effects on abstinence for either adherence strategy. Abstinence rates were 25.7%-32.2% among participants that used all three treatment components (sk+comm +meds).Treatment utilization analyses revealed that among such participants, sk+comm+meds yielded large percentage point increases in 3-month abstinence rates over sk alone across arms: WEB = 20.6 (95% CI = 10.8, 30.4), WEB + SN = 19.2 (95% CI = 11.1, 27.3), WEB + NRT = 13.1 (95% CI = 4.1, 22.0), and WEB + SN + NRT = 20.0 (95% CI = 12.2, 27.7). Novel propensity weighting approaches can serve as a model for establishing efficacy of Internet interventions and yield important insights about mechanisms. NCT01544153.

  7. Big Explosions, Strong Gravity: Making Girl Scouts ACEs of Space through Chandra Outreach

    Science.gov (United States)

    Hornschemeier, A. E.; Lochner, J. C.; Ganguly, R.; Feaga, L. M.; Ford, K. E. S.

    2005-12-01

    Thanks to two years of Chandra E/PO funding we have carried out a number of successful activities with the Girl Scouts of Central Maryland, focusing on girls in the 11-17 year age range. Our reasons for targeting this age range include the general decline in interest in math and science that occurs at or after children reach this critical age (meaning that we reach them early enough to have a positive effect). We initially target girls due to their underrepresentation in science, but the actitivities are all gender-neutral and highly adaptable to other groups. The program includes two components, in collaboration with Girl Scouts of Central Maryland. The first component is a well-established one-day Girl Scout patch activity entitled Big Explosions and Strong Gravity (BESG) where the girls earn a patch for their badge sash. The four BESG activities, mostly adapted from existing E/PO material, are available on the World Wide Web for use by others. The activities cover the electromagnetic spectrum as a tool for astronomy, the cosmic abundance of the elements and the supernova origin of many of the elements, black holes and their detection, and supernova explosions/stellar evolution. Thus far approximately 200 girls and their parents have participated in BESG and it has now become part of the council culture. The second activity is new and is part of the relatively new Girl Scout Studio 2B program, which is a girl-led program for the 11-17 year age range. Based on several meetings with small groups of girls and adults, we have formed a Studio 2B "club" called the ACE of Space Club (Astronomical Cosmic Exploration). We'll describe our experiences interacting with the Girl Scouts in this girl-led program.

  8. Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

    Science.gov (United States)

    van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

    2018-01-01

    had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

  9. Improved outcome in acute myeloid leukemia patients enrolled in clinical trials

    DEFF Research Database (Denmark)

    Østgård, Lene Sofie Granfeldt; Nørgaard, Mette; Sengeløv, Henrik

    2016-01-01

    Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial.We conducted a population-based coho...

  10. Does suprascapular nerve block reduce shoulder pain following stroke: a double-blind randomised controlled trial with masked outcome assessment

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    Crotty Maria

    2010-09-01

    Full Text Available Abstract Background Shoulder pain is a common complication of a stroke which can impede participation in rehabilitation programs and has been associated with poorer outcomes. The evidence base for current medical and therapeutic management options of hemiplegic shoulder pain is limited. This study will evaluate the use of suprascapular nerve block injection as part of an interdisciplinary approach to the treatment of shoulder pain following stroke. The technique has previously been proven safe and effective in the treatment of shoulder pain associated with rheumatoid arthritis and degenerative shoulder conditions but its usefulness in a stroke population is unclear. Methods/Design A double blind randomised placebo controlled trial will assess the effect of a suprascapular nerve block compared with placebo in a population of 66 stroke patients. The trial will measure effect of injection on the primary outcome of pain, and secondary outcomes of function and quality of life. Measurements will take place at baseline, and 1, 4 and 12 weeks post intervention. Both groups will continue to receive routine physiotherapy and standard ward care. Discussion The results of this study could reduce pain symptoms in persons with mechanical shoulder pain post stroke and provide improvement in upper limb function. Trial Registration This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR - ACTRN12609000621213.

  11. Are obsessive-compulsive personality traits associated with a poor outcome in anorexia nervosa? A systematic review of randomized controlled trials and naturalistic outcome studies.

    Science.gov (United States)

    Crane, Anna M; Roberts, Marion E; Treasure, Janet

    2007-11-01

    Obsessive-compulsive personality disorder (OCPD) traits are commonly associated with anorexia nervosa (AN). The aim of this review was to systematically search the literature to examine whether OCPD traits have an impact on the outcome of AN. A systematic electronic search of the literature (using Medline, PsycINFO, and the Cochrane Central Register of Controlled Trials) was undertaken to identify relevant publications (randomized controlled trials (RCT's) and naturalistic studies), until February 2006. Eleven prospective longitudinal studies and 12 RCT's met criteria for inclusion. A meta-analysis was not feasible as the studies were too heterogeneous. Just over half of published longitudinal studies found that OCPD traits were associated with a negative outcome in AN. Additionally, results from three RCTs suggested that these traits may moderate outcome. OCPD traits were reduced after treatment in five RCTs. There is tentative support to suggest that individuals with AN and concomitant OCPD traits have a poorer prognosis, and that these traits moderate outcome. A reduction in these traits may mediate this change. An individualized case formulation with treatment tailored to OCPD traits may improve the outcome of AN. (c) 2007 by Wiley Periodicals, Inc.

  12. Early clinical outcomes as a function of use of newer oral P2Yinhibitors versus clopidogrel in the EUROMAX trial

    DEFF Research Database (Denmark)

    Huber, Kurt; Ducrocq, Gregory; Hamm, Christian W

    2017-01-01

    Objective: To ascertain whether different oral P2Y12inhibitors might affect rates of acute stent thrombosis and 30-day outcomes after primary percutaneous coronary intervention (pPCI). Methods: The European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) randomised trial compared prehospi...

  13. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects w...

  14. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

    NARCIS (Netherlands)

    Chalmers, J. R.; Schmitt, J.; Apfelbacher, C.; Dohil, M.; Eichenfield, L. F.; Simpson, E. L.; Singh, J.; Spuls, P.; Thomas, K. S.; Admani, S.; Aoki, V.; Ardeleanu, M.; Barbarot, S.; Berger, T.; Bergman, J. N.; Block, J.; Borok, N.; Burton, T.; Chamlin, S. L.; Deckert, S.; DeKlotz, C. C.; Graff, L. B.; Hanifin, J. M.; Hebert, A. A.; Humphreys, R.; Katoh, N.; Kisa, R. M.; Margolis, D. J.; Merhand, S.; Minnillo, R.; Mizutani, H.; Nankervis, H.; Ohya, Y.; Rodgers, P.; Schram, M. E.; Stalder, J. F.; Svensson, A.; Takaoka, R.; Teper, A.; Tom, W. L.; von Kobyletzki, L.; Weisshaar, E.; Zelt, S.; Williams, H. C.

    2014-01-01

    This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6-7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial:

  15. The Anglo-Scandinavian Cardiac Outcomes Trial: blood pressure-lowering limb: effects in patients with type II diabetes

    DEFF Research Database (Denmark)

    Ostergren, Jan; Poulter, Neil R; Sever, Peter S

    2008-01-01

    OBJECTIVE: To compare the effects of two antihypertensive treatment strategies for the prevention of coronary heart disease and other cardiovascular events in the large subpopulation (n=5137) with diabetes mellitus in the blood pressure-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial...... nonsignificantly by 8% (hazard ratio 0.92, confidence interval 0.74-1.15). CONCLUSION: In the large diabetic subgroup in the blood pressure-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial, the benefits of amlodipine-based treatment, compared with atenolol-based treatment, on the incidence of total...... with addition of thiazide as required (atenolol-based). Therapy was titrated to achieve a target blood pressure of less than 130/80 mmHg. RESULTS: The trial was terminated early due to significant benefits on mortality and stroke associated with the amlodipine-based regimen. In patients with diabetes mellitus...

  16. Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study [v2; ref status: indexed, http://f1000r.es/5bj

    Directory of Open Access Journals (Sweden)

    Sreeram V Ramagopalan

    2015-04-01

    Full Text Available Background: We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. Methods: A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Findings: 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3% had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome. Conclusions: Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

  17. Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial.

    Science.gov (United States)

    Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun

    2014-03-26

    Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. ClinicalTrials

  18. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

    Directory of Open Access Journals (Sweden)

    Jones PW

    2016-12-01

    Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

  19. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Saywell Nicola

    2012-12-01

    Full Text Available Abstract Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community, participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their

  20. ‘Alzheimer’s Progression Score’: Development of a Biomarker Summary Outcome for AD Prevention Trials

    Science.gov (United States)

    Leoutsakos, J.-M.; Gross, A.L.; Jones, R.N.; Albert, M.S.; Breitner, J.C.S.

    2017-01-01

    IRT-based APS can summarize multimodal information to provide a longitudinal measure of pre-clinical AD progression, and holds promise as an outcome for AD prevention trials. PMID:29034223

  1. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

  2. Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

    Science.gov (United States)

    Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

    2012-10-01

    Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

  3. Association between B vitamins supplementation and risk of cardiovascular outcomes: a cumulative meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Chi Zhang

    Full Text Available BACKGROUND: Observational studies suggest that B vitamin supplementation reduces cardiovascular risk in adults, but this association remains controversial. This study aimed to summarize the evidence from randomized controlled trials (RCTs investigating B vitamin supplementation for the primary or secondary prevention of major adverse cardiovascular outcomes and to perform a cumulative meta-analysis to determine the evidence base. METHODOLOGY AND PRINCIPAL FINDINGS: In April 2013, we searched PubMed, Embase, and the Cochrane Library to identify relevant RCTs. We included RCTs investigating the effect of B vitamin supplementation on cardiovascular outcome. Relative risk (RR was used to measure the effect using a random-effect model. Statistical heterogeneity scores were assessed using the Q statistic. We included data on 57,952 individuals from 24 RCTs: 12 primary prevention trials and 12 secondary prevention trials. In 23 of these trials, 10,917 major adverse cardiovascular events (MACE occurred; in 20 trials, 7,203 deaths occurred; in 15 trials, 3,422 cardiac deaths occurred; in 19 trials, 3,623 myocardial infarctions (MI occurred; and in 18 trials, 2,465 strokes occurred. B vitamin supplementation had little or no effect on the incidence of MACE (RR, 0.98; 95% confidence interval [CI]: 0.93-1.03; P = 0.37, total mortality (RR, 1.01; 95% CI: 0.97-1.05; P = 0.77, cardiac death (RR, 0.96; 95% CI: 0.90-1.02; P = 0.21, MI (RR, 0.99; 95% CI: 0.93-1.06; P = 0.82, or stroke (RR, 0.94; 95% CI: 0.85-1.03; P = 0.18. CONCLUSION/SIGNIFICANCE: B vitamin supplementation, when used for primary or secondary prevention, is not associated with a reduction in MACE, total mortality, cardiac death, MI, or stroke.

  4. Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

    Science.gov (United States)

    Kilbourne, Amy M; Almirall, Daniel; Eisenberg, Daniel; Waxmonsky, Jeanette; Goodrich, David E; Fortney, John C; Kirchner, JoAnn E; Solberg, Leif I; Main, Deborah; Bauer, Mark S; Kyle, Julia; Murphy, Susan A; Nord, Kristina M; Thomas, Marshall R

    2014-09-30

    Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months. This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as implementation costs, and organizational change. This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF. ClinicalTrials.gov identifier: NCT02151331.

  5. Effects of piroxicam administration on pregnancy outcome in intrauterine insemination (IUI) cycles: a randomized clinical trial.

    Science.gov (United States)

    Zarei, A; Mahboubi, M; Parsanezhad, M E; Alborzi, S; Younesi, M; Madadi, G

    2016-01-01

    Uterus contractibility is considered a powerful prognostic factor in predicting the embryo transfer outcome. Moreover, uterine contractions are known to be stimulated by prostaglandins which are produced by cyclooxygenase from arachidonic acid. As such, suppressing the inflammatory response and contractions using anti-inflammatory and relaxant agents is expected to result in increased success rate of embryo transfer and artificial insemination. To investigate the effect of piroxicam administration on the success rate in intrauterine insemination (IU) cycles in patients presenting with unexplained infertility. This randomized, placebo-controlled clinical trial included 260 women with unexplained infertility undergoing IUI cycles. Patients were randomly assigned to receive either piroxicam ten mg/day on days 4-6 after IUI or placebo (control group). The main outcome measures were number of IUI cycles, pregnancy, abortion, and multiple pregnancy rates. The pregnancy rate was found to be 25 (19.2%) and 16 (12.3%) in piroxicam and control groups, respectively (p = 0.039). Five patients (3.8%) in piroxicam group experienced twin pregnancy whereas only three patients (2.3%) in control group had twin pregnancy (p = 0.361). The pregnancy rate per cycle was also significantly higher in those who received piroxicam as compared to controls (11.16 vs. 6.66; p = 0.021). Administration of piroxicam after IUI is associated with decreased number of cycles, as well as increased pregnancy rate and pregnancy rate per cycle in IUI cycles. However, piroxicam did not have any effect on abortion, multiple pregnancy, and ongoing pregnancy rates.

  6. Early Outcomes From Three Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Li Zuofeng; Hoppe, Bradford S.; Marcus, Robert B.; Mendenhall, William M.; Nichols, R. Charles; Morris, Christopher G.; Williams, Christopher R.; Costa, Joseph; Henderson, Randal

    2012-01-01

    Purpose: To report early outcomes with image-guided proton therapy for prostate cancer. Methods and Materials: We accrued 211 prostate cancer patients on prospective Institutional Review Board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low–risk disease, dose escalation from 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel followed by androgen deprivation for high-risk disease. Minimum follow-up was 2 years. Results: One intermediate-risk patient and 2 high-risk patients had disease progression. Pretreatment genitourinary (GU) symptom management was required in 38% of patients. A cumulative 88 (42%) patients required posttreatment GU symptom management. Four transient Grade 3 GU toxicities occurred, all among patients requiring pretreatment GU symptom management. Multivariate analysis showed correlation between posttreatment GU 2+ symptoms and pretreatment GU symptom management (p < 0.0001) and age (p = 0.0048). Only 1 Grade 3+ gastrointestinal (GI) symptom occurred. The prevalence of Grade 2+ GI symptoms was 0 (0%), 10 (5%), 12 (6%), and 8 (4%) at 6, 12, 18, and 24 months, with a cumulative incidence of 20 (10%) patients at 2 years after proton therapy. Univariate and multivariate analyses showed significant correlation between Grade 2+ rectal bleeding and proctitis and the percentage of rectal wall (rectum) receiving doses ranging from 40 CGE (10 CGE) to 80 CGE. Conclusions: Early outcomes with image-guided proton therapy suggest high efficacy and minimal toxicity with only 1.9% Grade 3 GU symptoms and <0.5% Grade 3 GI toxicities.

  7. Early Outcomes From Three Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, FL (United States); Li Zuofeng; Hoppe, Bradford S.; Marcus, Robert B.; Mendenhall, William M.; Nichols, R. Charles; Morris, Christopher G. [University of Florida Proton Therapy Institute, Jacksonville, FL (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, FL (United States); Henderson, Randal [University of Florida Proton Therapy Institute, Jacksonville, FL (United States)

    2012-01-01

    Purpose: To report early outcomes with image-guided proton therapy for prostate cancer. Methods and Materials: We accrued 211 prostate cancer patients on prospective Institutional Review Board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, dose escalation from 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel followed by androgen deprivation for high-risk disease. Minimum follow-up was 2 years. Results: One intermediate-risk patient and 2 high-risk patients had disease progression. Pretreatment genitourinary (GU) symptom management was required in 38% of patients. A cumulative 88 (42%) patients required posttreatment GU symptom management. Four transient Grade 3 GU toxicities occurred, all among patients requiring pretreatment GU symptom management. Multivariate analysis showed correlation between posttreatment GU 2+ symptoms and pretreatment GU symptom management (p < 0.0001) and age (p = 0.0048). Only 1 Grade 3+ gastrointestinal (GI) symptom occurred. The prevalence of Grade 2+ GI symptoms was 0 (0%), 10 (5%), 12 (6%), and 8 (4%) at 6, 12, 18, and 24 months, with a cumulative incidence of 20 (10%) patients at 2 years after proton therapy. Univariate and multivariate analyses showed significant correlation between Grade 2+ rectal bleeding and proctitis and the percentage of rectal wall (rectum) receiving doses ranging from 40 CGE (10 CGE) to 80 CGE. Conclusions: Early outcomes with image-guided proton therapy suggest high efficacy and minimal toxicity with only 1.9% Grade 3 GU symptoms and <0.5% Grade 3 GI toxicities.

  8. Relaxation Therapy on Fetal Outcomes in Complicated Pregnancies Suffering Sleep Disorders: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    azar nematollahi

    2016-10-01

    Full Text Available Background: Sleep disorders like snoring, mouth breathing, and insomnia are frequent in pregnancy and studies have shown that poor sleep is linked to obstetric complications. Muscle relaxation technique is an effective method used for improving sleep quality. The purpose of this study was to determine the effect of muscle relaxation technique on fetal outcomes in complicated pregnancies with sleep disorders. Methods: This study was performed as a clinical trial on 160 pregnant women who suffered from preeclampsia and gestational diabetes. The participants filled the Pittsburgh Sleep Quality Index (PSQI in order to measure the quality and patterns of their sleep. The participants with the total score of 5 or more were included in the present study. Intervention group were asked to use muscle relaxation technique twice a week at home for 8 weeks alongside the routine care. Study variables included sleep quality, Apgar scores, birth weight, levels of Interleukin- 6 (IL- 6, as well as umbilical cord PH and PO2. Results: The mean score of PSQI before the intervention was 9.28±4.16 and 9.18±3.06 in the intervention and control groups without a significant difference (P=0.6, respectively. However, PSQI global score of the experimental group was smaller than the control group at the end of the study (P<0.001. Also, birth weight (P=0.04, Apgar score (P=0.01, and umbilical cord blood po2 (P=0.03 and PH (P=0.01 were higher, and IL-6 (P=0.04 was smaller in the experimental group compared to the control group. Conclusion: The results of this study showed that muscle relaxation, as a simple, inexpensive and safe method, can improve the fetal outcomes such as birth weight, Apgar score, cord blood po2, and cord blood PH, and also it leads to lower IL-6 in complicated pregnancies.

  9. The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Eriksson G

    2017-05-01

    Full Text Available Göran Eriksson,1 Peter M Calverley,2 Christine R Jenkins,3,4 Antonio R Anzueto,5 Barry J Make,6 Magnus Lindberg,7 Malin Fagerås,7 Dirkje S Postma8 1Department of Respiratory Medicine and Allergology, University Hospital, Lund, Sweden; 2Pulmonary and Rehabilitation Research Group, University Hospital Aintree, Liverpool, UK; 3Concord Clinical School, University of Sydney, 4The George Institute for Global Health, Sydney, Australia; 5Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans’ Health Care System, San Antonio, Texas, 6Division of Pulmonary Sciences and Critical Care Medicine, National Jewish Health, University of Colorado, Denver, Colorado, USA; 7AstraZeneca R&D, Mölndal, Sweden; 8Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, GRIAC Research Institute, University of Groningen, Groningen, the Netherlands Background: When discontinuation in COPD randomized controlled trials (RCTs is unevenly distributed between treatments (differential dropout, the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in RCTs, in relation to study duration and COPD severity.Methods: A post hoc analysis of 2,345 patients from three RCTs of 6- and 12-month duration was performed to compare budesonide/formoterol and formoterol in moderate, severe, and very severe COPD. Outcomes were exacerbation rate, time-to-first exacerbation, or discontinuation; patients were stratified by disease severity. Outcomes were studied by censoring data monthly from 1 to 12 months.Results: In patients treated with budesonide/formoterol, annualized exacerbation rates (AERs were comparable for each study duration (rate ratio [RR] =0.6. With formoterol, the AER decreased with study duration (RR =1.20 at 1 month to RR =0.86 at 12 months. There was a treatment-related difference in

  10. Patient-reported outcomes and socioeconomic status as predictors of clinical outcomes following hematopoietic stem cell transplantation: A study from the BMT CTN 0902 trial

    Science.gov (United States)

    Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S; Martens, Michael; Le-Rademacher, Jennifer; Logan, Brent R; Lee, Stephanie J; Jacobsen, Paul B; Wood, William A; Jim, Heather SL; Wingard, John R; Horowitz, Mary M; Abidi, Muneer H; Fei, Mingwei; Rawls, Laura; Rizzo, J Douglas

    2016-01-01

    This secondary analysis of a large, multi-center Blood and Marrow Transplant Clinical Trials Network (BMT CTN) randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pre-transplant Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores (MCS and PCS) of the SF-36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (pincome was related to worse physical functioning (p=.005) and increased distress (p=.008); lack of employment pre-transplant was associated with worse physical functioning (p<.01); unmarried status was associated with worse sleep (p=.003). In this large heterogeneous cohort of HCT recipients, while PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage. PMID:27565521

  11. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

    2016-01-01

    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

  12. Addressing Younger Workers’ Needs: The Promoting U through Safety and Health (PUSH Trial Outcomes

    Directory of Open Access Journals (Sweden)

    Diane S. Rohlman

    2016-08-01

    Full Text Available Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health. All younger workers (14–24 years old hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen’s d 0.4. However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior.

  13. Addressing Younger Workers’ Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes

    Science.gov (United States)

    Rohlman, Diane S.; Parish, Megan; Elliot, Diane L.; Hanson, Ginger; Perrin, Nancy

    2016-01-01

    Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14–24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen’s d) 0.4). However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior. PMID:27517968

  14. Outcomes of Operative Vaginal Delivery during Trial of Labor after Cesarean Delivery.

    Science.gov (United States)

    Brock, Clifton O; Govindappagari, Shravya; Gyamfi-Bannerman, Cynthia

    2017-07-01

    Objective  The objective of this study is to determine the maternal and neonatal morbidity associated with attempting operative vaginal delivery (OVD) compared with the alternative of a laboring repeat cesarean delivery (LRCD) in women attempting a trial of labor after cesarean delivery (TOLAC). Methods  This is a secondary analysis of a multicenter prospective study designed to assess perinatal outcomes of OVD in women with a prior uterine scar. The study includes women who attempted TOLAC and reached +2 station with a fully dilated cervix. Composites on neonatal and maternal morbidity were compared between women in whom OVD was attempted and those who underwent LRCD by fitting multivariate logistic regression models. Results  In total, 6,489 women attempting TOLAC reached 2+ station with a fully dilated cervix. Of these, 5,640 (86.9%) had a spontaneous vaginal delivery, 762 (11.7%) underwent attempted OVD, and 87 (1.3%) had an LRCD. Compared with attempting OVD, LRCD was associated with greater neonatal morbidity (odds ratio [OR]: 2.41; 95% confidence interval [CI]: 1.13-5.15) and less maternal morbidity (OR: 0.28; 95% CI: 0.14-0.55). Maternal morbidity of OVD is driven by perineal injury. Conclusion  In laboring women with a previous uterine scar, attempting OVD is associated with greater maternal and less neonatal morbidity than LRCD. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  15. Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

    Science.gov (United States)

    Bruner, Deborah Watkins; Bryan, Charlene J.; Aaronson, Neil; Blackmore, C. Craig; Brundage, Michael; Cella, David; Ganz, Patricia A.; Gotay, Carolyn; Hinds, Pamela S.; Kornblith, Alice B.; Movsas, Benjamin; Sloan, Jeff; Wenzel, Lari; Whalen, Giles

    2016-01-01

    Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need

  16. A Cost Benefit Analysis of Fire Scout Vertical Takeoff and Landing Tactical Unmanned Aerial Vehicle (VTUAV) Operator Alternatives

    Science.gov (United States)

    2012-03-01

    mile mission radius.24 Like the MH-60R manned helicopter, the Fire Scout mission systems suite includes Infrared Imaging, Electro Optical Imaging...homecoming just as sweet." dcmilitary.com. February 21, 2008. http:// ww2 .dcmilitary.com/stories/022108/southpotomac_28121.shtml (accessed February 29... ww2 .dcmilitary.com/stories/022108/southpotomac_28121.shtml (accessed February 29, 2012). Tilghman, Andrew. "Fire Scout Program could open door for

  17. SU-E-T-431: Feasiblity of Using CT Scout Images for 2D LDR Brachytherpay Planning

    Energy Technology Data Exchange (ETDEWEB)

    Ha, J; Weaver, R [LAC+USC Medical Center, Los Angeles, CA, M. Mariscal (United States)

    2015-06-15

    Purpose: i) To show the feasibility of using CT scout images for 2D low-dose rate brachytherapy planning with BrachyVision (version 10.4); ii) to show their advantages and disadvantages over DRRs. Methods: A phantom was constructed to house a Fletcher-Suite applicator. The phantom is made of Styrofoam with metal BBs positioned at well-defined separations. These markers are used to assess the image distortion in the scout images. Unlike DRRs, scout images are distorted only in the direction normal to the couch direction; therefore, they needed to be scaled unidirectionally prior to importing into BrachyVision. In addition to confirming the scaling is performed correctly by measuring distances between well-positioned BB, we also compare a LDR plan using scout images to a 3D CT-based plan. Results: There is no distortion of the image along the couch direction due to the collimation of the CT scanner. The distortion in the transverse plane can be corrected by multiplying by the ratio of distances between source-to-isocenter and source-to-detector. The results show the distance separations between BBs as measured in scout images and by a caliber are within a few millimeters. Dosimetrically, the difference between the dose rates to points A and B based on scout images and on 3D CT are less than a few percents. The accuracy can be improved by correcting for the distortion on the transverse plane. Conclusion: It is possible to use CT scout images for 2D planning in BrachyVision. This is an advantage because scout images have no metal artifacts often present in CT images or DRRs. Another advantage is the lack of distortion in the couch direction. One major disadvantage is that the image distortion due to beam divergence can be large. This is due to the inherent short distance between source-to-isocenter and source-to-detector on a CT scanner.

  18. Lessons for Interstellar Travel from the Guidance and Control Design of the Near Earth Asteroid Scout Solar Sail Mission

    Science.gov (United States)

    Diedrich, Benjamin; Heaton, Andrew

    2017-01-01

    NASA is developing the Near Earth Asteroid (NEA) Scout mission that will use a solar sail to travel to an asteroid where it will perform a slow flyby to acquire science imagery. A guidance and control system was developed to meet the science and trajectory requirements. The NEA Scout design process can be applied to an interstellar or precursor mission that uses a beam propelled sail. The scientific objectives are met by accurately targeting the destination trajectory position and velocity. The destination is targeted by understanding the force on the sail from the beam (or sunlight in the case of NEA Scout) over the duration of the thrust maneuver. The propulsive maneuver is maintained by accurate understanding of the torque on the sail, which is a function of sail shape, optical properties, and mass properties, all of which apply to NEA Scout and beam propelled sails. NEA Scout uses active control of the sail attitude while trimming the solar torque, which could be used on a beamed propulsion sail if necessary. The biggest difference is that NEA Scout can correct for uncertainties in sail thrust modeling, spacecraft orbit, and target orbit throughout the flight to the target, while beamed propulsion needs accurate operation for the short duration of the beamed propulsion maneuver, making accurate understanding of the sail thrust and orbits much more critical.

  19. Lessons for Interstellar Travel from the G&C Design of the NEA Scout Solar Sail Mission

    Science.gov (United States)

    Heaton, Andrew; Diedrich, Benjamin

    2017-01-01

    NASA is developing the Near Earth Asteroid (NEA) Scout mission that will use a solar sail to travel to an asteroid where it will perform a slow flyby to acquire science imagery. A guidance and control system was developed to meet the science and trajectory requirements. The NEA Scout design process can be applied to an interstellar or precursor mission that uses a beam-propelled sail. The scientific objectives are met by accurately targeting the destination trajectory position and velocity. The destination is targeted by understanding the force on the sail from the beam (or sunlight in the case of NEA Scout) over the duration of the thrust maneuver. The propulsive maneuver is maintained by accurate understanding of the torque on the sail, which is a function of sail shape, optical properties, and mass properties, all of which apply to NEA Scout and beam propelled sails. NEA Scout uses active control of the sail attitude while trimming the solar torque, which could be used on a beamed propulsion sail if necessary. The biggest difference is that NEA Scout can correct for uncertainties in sail thrust modeling, spacecraft orbit, and target orbit throughout the flight to the target, while beamed propulsion needs accurate operation for the short duration of the beamed propulsion maneuver, making accurate understanding of the sail thrust and orbits much more critical.

  20. Viewpoint: Central adjudication of myocardial infarction in outcome-driven clinical trials--common patterns in TRITON, RECORD, and PLATO?

    Science.gov (United States)

    Serebruany, Victor L; Atar, Dan

    2012-09-01

    Central adjudication in randomised controlled outcome-driven trials represents a traditional approach to maintain data integrity by applying uniformed rules for assessment of clinical events. It was the purpose of this investigation to determine the patterns of myocardial infarction (MI) adjudication in the TRITON, RECORD, and PLATO trials. We were matching centrally-adjudicated MI's (CAMI's) from the official trial publication with the site-reported MI (SRMI's) count from the Food and Drug Administration's secondary analyses for the investigational compounds prasugrel (TRITON), rosiglitazone (RECORD), and ticagrelor (PLATO). CAMI numbers showed a remarkable discrepancy to SRMI's by more than a doubling of the difference: from 72 to 145 events in TRITON favoring prasugrel (from a hazard ratio [HR]=0.76, p=0.08; to a HR=0.76, p<0.001), and from 44 to 89 events in favour of ticagrelor in PLATO (from a HR=0.94, p=0.095; to a HR=0.84, p<0.001). In contrast, in the RECORD trial, the CAMI count was less than the SRMI count (from 24 to 8 events, from a HR=1.42, p=0.93; to a HR=1.14, p=0.96), in this case diminishing cardiovascular hazards in favour of rosiglitazone. In conclusion, central adjudication in the TRITON, the RECORD, and the PLATO trial turned out to have a critical impact on study outcomes. Trial publications should in the future include site-reported major efficacy and safety endpoints to preserve data integrity. The regulatory authorities should consider independent audits when there is a major disagreement between centrally adjudicated and site reported events influencing the results of a major clinical trial.

  1. Immunoglobulins in Neonates with Rhesus Hemolytic Disease of the Fetus and Newborn: Long-Term Outcome in a Randomized Trial.

    Science.gov (United States)

    van Klink, Jeanine M M; van Veen, Suzanne J; Smits-Wintjens, Vivianne E H J; Lindenburg, Irene T M; Rijken, Monique; Oepkes, Dick; Lopriore, Enrico

    2016-01-01

    Prophylactic intravenous immunoglobulin (IVIg) does neither reduce the need for exchange transfusion nor the rates of other adverse neonatal outcomes in neonates with rhesus hemolytic disease of the fetus and newborn (rhesus HDFN) according to our randomized controlled trial analysis. Our objective was to assess the long-term neurodevelopmental outcome in the children included in the trial and treated with either IVIg or placebo. All families of the children included in the trial were asked to participate in this follow-up study. The long-term neurodevelopmental outcome in children at least 2 years of age was assessed using standardized tests. The primary outcome was the incidence of neurodevelopmental impairment defined as at least one of the following: cerebral palsy, severe cognitive and/or motor developmental delay (with a test score of less than -2 SD), bilateral deafness or blindness. Sixty-six of the 80 children (82.5%) who had been recruited to the initial randomized controlled trial participated in the follow-up study. The children were assessed at a median age of 4 years (range 2-7). The median cognitive score was 96 (range 68-118) in the IVIg group and 97 (range 66-118) in the placebo group (p = 0.79). There was no difference in the rate of neurodevelopmental impairment between the IVIg and the placebo group [3% (1/34) vs. 3% (1/32); p = 1.00]. The long-term neurodevelopmental outcome in children treated with IVIg was not different from that in children treated with placebo. Standardized long-term follow-up studies with large enough case series and sufficient power are needed to replicate these findings. © 2015 S. Karger AG, Basel.

  2. A modified scout bee for artificial bee colony algorithm and its performance on optimization problems

    Directory of Open Access Journals (Sweden)

    Syahid Anuar

    2016-10-01

    Full Text Available The artificial bee colony (ABC is one of the swarm intelligence algorithms used to solve optimization problems which is inspired by the foraging behaviour of the honey bees. In this paper, artificial bee colony with the rate of change technique which models the behaviour of scout bee to improve the performance of the standard ABC in terms of exploration is introduced. The technique is called artificial bee colony rate of change (ABC-ROC because the scout bee process depends on the rate of change on the performance graph, replace the parameter limit. The performance of ABC-ROC is analysed on a set of benchmark problems and also on the effect of the parameter colony size. Furthermore, the performance of ABC-ROC is compared with the state of the art algorithms.

  3. Scout house in Koeniz - Refurbishment of the heating system; Pfadiheim Weiermatt, Sanierung Waermeversorgung - Schlussbericht

    Energy Technology Data Exchange (ETDEWEB)

    Messerli, A. [Neuenschwander - Neutair AG, Berne (Switzerland); Jenni, H. [Heimverein Falkenstein, Koeniz (Switzerland)

    2004-07-01

    This final report for the Swiss Federal Office of Energy (SFOE) presents the results of a project carried out in Koeniz, Switzerland. The report examines how the energy situation at the local scout house was improved. The work included the refurbishment of the heating system using solar collectors, intelligently controlled heat pumps, a photovoltaics installation and even solar-powered street lighting. The project, which received a substantial echo from the general public, is described. The scouts were directly involved in the project and, in part, in the construction work. This, according to the authors, enhanced the educational aspect of the project. The report presents details on the various installations and is illustrated with schematics and photos. Also, the results of monitoring and measurements made are presented.

  4. Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study.

    Science.gov (United States)

    Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

    2017-10-04

    Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.

  5. Protocol for: Sheffield Obesity Trial (SHOT: A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112

    Directory of Open Access Journals (Sweden)

    Wright Neil P

    2005-10-01

    Full Text Available Abstract Background While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT will provide evidence of the efficacy of supervised exercise therapy in obese young people aged 11–16 years versus usual care and an attention-control intervention. Method/design SHOT is a randomised controlled trial where obese young people are randomised to receive; (1 exercise therapy, (2 attention-control intervention (involving body-conditioning exercises and games that do not involve aerobic activity, or (3 usual care. The exercise therapy and attention-control sessions will take place three times per week for eight weeks and a six-week home programme will follow this. Ninety adolescents aged between 11–16 years referred from a children's hospital for evaluation of obesity or via community advertisements will need to complete the study. Participants will be recruited according to the following criteria: (1 clinically obese and aged 11–16 years (Body Mass Index Centile > 98th UK standard (2 no medical condition that would restrict ability to be active three times per week for eight weeks and (3 not diagnosed with insulin dependent diabetes or receiving oral steroids. Assessments of outcomes will take place at baseline, as well as four (intervention midpoint and eight weeks (end of intervention from baseline. Participants will be reassessed on outcome measures five and seven months from baseline. The primary endpoint is physical self-perceptions. Secondary outcomes include physical activity, self-perceptions, depression, affect, aerobic fitness and BMI.

  6. Fifteen-Year Radiotherapy Outcomes of the Randomized PORTEC-1 Trial for Endometrial Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Creutzberg, Carien L., E-mail: c.l.creutzberg@lumc.nl [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Nout, Remi A. [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Lybeert, Marnix L.M. [Department of Radiotherapy, Catharina Hospital Eindhoven (Netherlands); Warlam-Rodenhuis, Carla C. [Department of Radiation Oncology, University Medical Center Utrecht (Netherlands); Jobsen, Jan J. [Department of Radiotherapy, Medisch Spectrum Twente, Enschede (Netherlands); Mens, Jan-Willem M. [Department of Radiation Oncology, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Lutgens, Ludy C.H.W. [MAASTRO clinic, Maastricht (Netherlands); Pras, Elisabeth [Department of Radiotherapy, University Medical Center Groningen (Netherlands); Poll-Franse, Lonneke V. van de [Comprehensive Cancer Centre South, Eindhoven and Center of Research on Psychology in Somatic Diseases, Tilburg University (Netherlands); Putten, Wim L.J. van [Department of Biostatistics, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands)

    2011-11-15

    Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second cancers. Patients and Methods: The PORTEC trial (1990-1997) included 714 patients with Stage IC Grade 1-2 or Stage IB Grade 2-3 EC. After surgery, patients were randomly allocated to external-beam pelvic radiotherapy (EBRT) or no additional treatment (NAT). Analysis was by intention to treat. Results: 426 patients were alive at the date of analysis. The median follow-up time was 13.3 years. The 15-year actuarial locoregional recurrence (LRR) rates were 6% for EBRT vs. 15.5% for NAT (p < 0.0001). The 15-year overall survival was 52% vs. 60% (p = 0.14), and the failure-free survival was 50% vs. 54% (p = 0.94). For patients with high-intermediate risk criteria, the 15-year overall survival was 41% vs. 48% (p = 0.51), and the 15-year EC-related death was 14% vs. 13%. Most LRR in the NAT group were vaginal recurrences (11.0% of 15.5%). The 15-year rates of distant metastases were 9% vs. 7% (p = 0.25). Second primary cancers had been diagnosed over 15 years in 19% of all patients, 22% vs. 16% for EBRT vs. NAT (p = 0.10), with observed vs. expected ratios of 1.6 (EBRT) and 1.2 (NAT) compared with a matched population (p = NS). Multivariate analysis confirmed the prognostic significance of Grade 3 for LRR (hazard ratio [HR] 3.4, p = 0.0003) and for EC death (HR 7.3, p < 0.0001), of age >60 (HR 3.9, p = 0.002 for LRR and 2.7, p = 0.01 for EC death) and myometrial invasion >50% (HR 1.9, p = 0.03 and HR 1.9, p = 0.02). Conclusions: The 15-year outcomes of PORTEC-1 confirm the relevance of HIR criteria for treatment selection, and a trend for long-term risk of second cancers. EBRT should be avoided in patients with low- and intermediate-risk EC.

  7. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue.

    Science.gov (United States)

    Puskas, John D; Bavaria, Joseph E; Svensson, Lars G; Blackstone, Eugene H; Griffith, Bartley; Gammie, James S; Heimansohn, David A; Sadowski, Jerzy; Bartus, Krzysztof; Johnston, Douglas R; Rozanski, Jacek; Rosengart, Todd; Girardi, Leonard N; Klodell, Charles T; Mumtaz, Mubashir A; Takayama, Hiroo; Halkos, Michael; Starnes, Vaughn; Boateng, Percy; Timek, Tomasz A; Ryan, William; Omer, Shuab; Smith, Craig R

    2017-09-01

    The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™). clinicaltrials.gov: NCT01757665. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  8. Leveraging Non-Cognitive Testing to Predict Success at USMC Scout Sniper Course

    Science.gov (United States)

    2017-03-01

    whether aptitude requirements translate to job performance. Mayberry (1990) determines the ASVAB a valid predictor of success for infantrymen...Reduction Project (0704-0188) Washington, DC 20503. 1. AGENCY USE ONLY (Leave blank) 2. REPORT DATE March 2017 3. REPORT TYPE AND DATES COVERED...success at scout sniper school. We use data from 2012 through 2016 containing more than 700 Marines from every infantry military occupational specialty

  9. Solar Sail Attitude Control System for the NASA Near Earth Asteroid Scout Mission

    Science.gov (United States)

    Orphee, Juan; Diedrich, Ben; Stiltner, Brandon; Becker, Chris; Heaton, Andrew

    2017-01-01

    An Attitude Control System (ACS) has been developed for the NASA Near Earth Asteroid (NEA) Scout mission. The NEA Scout spacecraft is a 6U cubesat with an eighty-six square meter solar sail for primary propulsion that will launch as a secondary payload on the Space Launch System (SLS) Exploration Mission 1 (EM-1) and rendezvous with a target asteroid after a two year journey, and will conduct science imagery. The spacecraft ACS consists of three major actuating subsystems: a Reaction Wheel (RW) control system, a Reaction Control System (RCS), and an Active Mass Translator (AMT) system. The reaction wheels allow fine pointing and higher rates with low mass actuators to meet the science, communication, and trajectory guidance requirements. The Momentum Management System (MMS) keeps the speed of the wheels within their operating margins using a combination of solar torque and the RCS. The AMT is used to adjust the sign and magnitude of the solar torque to manage pitch and yaw momentum. The RCS is used for initial de-tumble, performing a Trajectory Correction Maneuver (TCM), and performing momentum management about the roll axis. The NEA Scout ACS is able to meet all mission requirements including attitude hold, slews, pointing for optical navigation and pointing for science with margin and including flexible body effects. Here we discuss the challenges and solutions of meeting NEA Scout mission requirements for the ACS design, and present a novel implementation of managing the spacecraft Center of Mass (CM) to trim the solar sail disturbance torque. The ACS we have developed has an applicability to a range of potential missions and does so in a much smaller volume than is traditional for deep space missions beyond Earth.

  10. Evaluation Models of Some Morphological Characteristcs for Talent Scouting in Sport

    OpenAIRE

    Rogulj, Nenad; Papić, Vladan; Čavala, Marijana

    2009-01-01

    In this paper, for the purpose of expert system evaluation within the scientific project »Talent scouting in sport«, two methodological approaches for recognizing an athlete’s morphological compatibility for various sports has been presented, evaluated and compared. First approach is based on the fuzzy logic and expert opinion about compatibility of proposed hypothetical morphological models for 14 different sports which are part of the expert system. Second approach is based on determining t...

  11. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

    Science.gov (United States)

    Edwards, Meghan K; Loprinzi, Paul D

    2018-03-01

    No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

  12. Waterborne gastroenteritis outbreak at a scouting camp caused by two norovirus genogroups: GI and GII.

    Science.gov (United States)

    ter Waarbeek, Henriëtte L G; Dukers-Muijrers, Nicole H T M; Vennema, Harry; Hoebe, Christian J P A

    2010-03-01

    A cross-border gastroenteritis outbreak at a scouting camp was associated with drinking water from a farmer's well. A retrospective cohort study was performed to identify size and source of the outbreak, as well as other characteristics. Epidemiological investigation included standardized questionnaires about sex, age, risk exposures, illness and family members. Stool and water (100mL) samples were analyzed for bacteria, viruses and parasites. Questionnaires were returned by 84 scouts (response rate 82%), mean age of 13 years. The primary attack rate was 85% (diarrhoea and/or vomiting). Drinking water was the strongest independent risk factor showing a dose-response effect with 50%, 75%, 75%, 93% and 96% case prevalence for 0, 1, 2-3, 4-5 and >5 glasses consumed, respectively. Norovirus (GI.2 Southampton and GII.7 Leeds) was detected in 51 stool specimens (75%) from ill scouts. Water analysis showed fecal contamination, but no norovirus. The secondary attack rate was 20%. This remarkable outbreak was caused by a point-source infection with two genogroups of noroviruses most likely transmitted by drinking water from a well. Finding a dose-response relationship was striking. Specific measures to reduce the risk of waterborne diseases, outbreak investigation and a good international public health network are important.

  13. Preoperative nonsteroidal anti-inflammatory drug or steroid and outcomes after trabeculectomy: a randomized controlled trial.

    Science.gov (United States)

    Breusegem, Christophe; Spielberg, Leigh; Van Ginderdeuren, Rita; Vandewalle, Evelien; Renier, Charlotte; Van de Veire, Sara; Fieuws, Steffen; Zeyen, Thierry; Stalmans, Ingeborg

    2010-07-01

    To investigate the benefit of preoperative treatment with either topical nonsteroidal anti-inflammatory drug (NSAID) or steroid in terms of clinical outcomes following trabeculectomy. Prospective, randomized placebo-controlled trial. Sixty-one patients. Between July 2005 and October 2007, 61 consecutive medically uncontrolled glaucoma patients scheduled for first-time trabeculectomy were randomized to 1 of 3 study topical medication groups: nonsteroidal anti-inflammatory drugs (ketorolac), steroids (fluorometholone), or placebo (artificial tears). Patients instilled 1 drop 4 times daily for 1 month before the procedure and were examined on days 1 and 2, at weeks 1, 2, and 4, and at months 3, 6, 12, 18, and 24 after trabeculectomy. Incidence of postoperative surgical or medical interventions (needling, laser suture lysis, needling revision, and intraocular pressure [IOP]-lowering medication). Fifty-four patients (54 eyes) were entered for analysis. The mean number of preoperative medications was 2.3+/-0.9. The mean baseline IOP was 21.0+/-6.0 mmHg. The mean postoperative target IOP was 16.5+/-1.8 mmHg. The mean follow-up was 23.6+/-4.0 months. The percentage of patients requiring needling within the first year was 41% in the placebo group, 6% in the NSAID, and 5% in the steroid group (P = 0.006). The percentage of patients requiring IOP-lowering medication to reach the target IOP at 1 year was 24% in the placebo group, 18% in the NSAID group, and 0% in the steroid group (P = 0.054 overall; P = 0.038 for steroids vs. others). The log-rank test showed a significant (P = 0.019) difference in medication-free survival curves between the different groups. More specifically, patients in the steroid group needed significantly less medication over the total follow-up (P = 0.007). Topical ketorolac or fluorometholone for 1 month before surgery was associated with improved trabeculectomy outcomes in terms of likelihood of postoperative needling. In the steroid group, there was

  14. Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer - a prospective trial

    International Nuclear Information System (INIS)

    Rief, Harald; Heinhold, Rita C; Petersen, Lina C; Rieken, Stefan; Bruckner, Thomas; Moghaddam-Alvandi, Arash; Debus, Jürgen; Sterzing, Florian

    2013-01-01

    The aim of this trial was to investigate neurological outcome after emergency RT in MSCC of NSCLC patients with acute neurological deficit. This pilot trial was prospective, non-randomized, and monocentre, ten patients were treated from July 2012 until June 2013. After onset of neurological symptoms RT was started within 12 hours. The neurological outcome was assessed at baseline, and six weeks after RT using the ASIA Impairment Scale (AIS). The results showed an improved neurological outcome in one patient (10%), one patient (10%) had a decreased, and five patients (50%) a constant outcome after six weeks. Three patients (30%) died within the first six weeks following RT, additional 4 patients (40%) died within 4 month due to tumor progression. In this group of NSCLC patients we were able to show that emergency RT in MSCC with acute neurological deficit had no considerable benefit in neurological outcome. Therefore, short-course regime or best supportive care due to poor survival should be considered for these patients with additional distant metastases. Patients with favorable prognosis may be candidates for long-course RT

  15. Surgical decompression for space-occupying cerebral infarction: outcomes at 3 years in the randomized HAMLET trial.

    Science.gov (United States)

    Geurts, Marjolein; van der Worp, H Bart; Kappelle, L Jaap; Amelink, G Johan; Algra, Ale; Hofmeijer, Jeannette

    2013-09-01

    We assessed whether the effects of surgical decompression for space-occupying hemispheric infarction, observed at 1 year, are sustained at 3 years. Patients with space-occupying hemispheric infarction, who were enrolled in the Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial within 4 days after stroke onset, were followed up at 3 years. Outcome measures included functional outcome (modified Rankin Scale), death, quality of life, and place of residence. Poor functional outcome was defined as modified Rankin Scale >3. Of 64 included patients, 32 were randomized to decompressive surgery and 32 to best medical treatment. Just as at 1 year, surgery had no effect on the risk of poor functional outcome at 3 years (absolute risk reduction, 1%; 95% confidence interval, -21 to 22), but it reduced case fatality (absolute risk reduction, 37%; 95% confidence interval, 14-60). Sixteen surgically treated patients and 8 controls lived at home (absolute risk reduction, 27%; 95% confidence interval, 4-50). Quality of life improved between 1 and 3 years in patients treated with surgery. In patients with space-occupying hemispheric infarction, the effects of decompressive surgery on case fatality and functional outcome observed at 1 year are sustained at 3 years. http://www.controlled-trials.com. Unique identifier: ISRCTN94237756.

  16. Capillaroscopy as an Outcome Measure for Clinical Trials on the Peripheral Vasculopathy in SSc—Is It Useful?

    Directory of Open Access Journals (Sweden)

    Maurizio Cutolo

    2010-01-01

    Full Text Available Peripheral microvascular impairment in systemic sclerosis (SSc may be easily detected and scored in a safe noninvasive way by nailfold videocapillaroscopy (NVC. The paper highlights clinical conditions related to SSc in which NVC may represent an outcome measure of therapeutical interventions, by elaborating on their already assessed relationship with the NVC patterns and eventually scores. The 3 important biological/clinical conditions are: the positivity for SSc-specific serum autoantibodies, the presence of SSc skin digital ulcers (DUs and of pulmonary arterial hypertension (PAH SSc associated. In conclusion, to the question if capillaroscopy (NVC may represent in SSc an outcome measure for clinical trials on the peripheral vasculopathy, based on the growing evidence and our detailed studies, the answer is positive. Recent therapeutic trials in SSc are confirming this role, and the experience is growing rapidly.

  17. Closing the knowledge gap on cardiovascular disease in type 2 diabetes: the EMPA-REG OUTCOME trial and beyond

    Directory of Open Access Journals (Sweden)

    Elif A Oral

    2016-09-01

    Full Text Available Type 2 diabetes mellitus (T2DM is associated with marked cardiovascular (CV morbidity and mortality, including heartfailure (HF. Until recently, an oral glucose-lowering agent that improved hyperglycemia as well as provided CV benefits in patients with T2DM and cardiovascular disease (CVD was lacking. The newest class of glucose-lowering agents, sodium glucose cotransporter 2 (SGLT2 inhibitors, includes canagliflozin, dapagliflozin, and empagliflozin. Prior to the release of the LEADER trial results, the recent EMPA-REG OUTCOME study was the only dedicated CV trial to demonstrate a reduction in major adverse cardiac events, CV mortality, and all-cause mortality and a reduction in hospitalization for HF with empagliflozin, given on top of standard-of-care therapy in patients with T2DM and CVD. This paper summarizes the results from EMPA-REG OUTCOME and discusses their significance and clinical implications.

  18. Sensitivity analysis for missing dichotomous outcome data in multi-visit randomized clinical trial with randomization-based covariance adjustment.

    Science.gov (United States)

    Li, Siying; Koch, Gary G; Preisser, John S; Lam, Diana; Sanchez-Kam, Matilde

    2017-01-01

    Dichotomous endpoints in clinical trials have only two possible outcomes, either directly or via categorization of an ordinal or continuous observation. It is common to have missing data for one or more visits during a multi-visit study. This paper presents a closed form method for sensitivity analysis of a randomized multi-visit clinical trial that possibly has missing not at random (MNAR) dichotomous data. Counts of missing data are redistributed to the favorable and unfavorable outcomes mathematically to address possibly informative missing data. Adjusted proportion estimates and their closed form covariance matrix estimates are provided. Treatment comparisons over time are addressed with Mantel-Haenszel adjustment for a stratification factor and/or randomization-based adjustment for baseline covariables. The application of such sensitivity analyses is illustrated with an example. An appendix outlines an extension of the methodology to ordinal endpoints.

  19. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

    Science.gov (United States)

    Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC

    2014-01-01

    Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient

  20. Persistent occiput posterior: OUTcomes following digital rotation: a pilot randomised controlled trial.

    Science.gov (United States)

    Graham, Kathryn; Phipps, Hala; Hyett, Jon A; Ludlow, Joanne P; Mackie, Adam; Marren, Anthony; De Vries, Bradley

    2014-06-01

    To determine the feasibility of a multicentre randomised controlled trial (RCT) to investigate whether digital rotation of the fetal head from occiput posterior (OP) position in the second stage of labour reduces the risk of operative delivery (defined as caesarean section (CS) or instrumental delivery). We conducted the study between December 2010 and December 2011 in a tertiary referral hospital in Australia. A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic, singleton pregnancies to determine the fetal position. Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure. In all other ways, participants received their usual intrapartum care. Data regarding demographics, mode of delivery, labour, post natal period and neonatal outcomes were collected. One thousand and four women were consented, 834 achieved full dilatation, and 30 were randomised. An additional portable ultrasound scan and a blinded 'sham' digital rotation were acceptable to women and staff. Operative delivery rates were 13/15 in the digital rotation (four CS and nine instrumental) and 12/15 in the sham (three CS and nine instrumental) groups, respectively. A large double-blinded multicentre RCT would be feasible and acceptable to women and staff. Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered. This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally. © 2014 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  1. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial.

    Science.gov (United States)

    Tolleson, Thaddeus R; O'Shea, J Conor; Bittl, John A; Hillegass, William B; Williams, Kathryn A; Levine, Glenn; Harrington, Robert A; Tcheng, James E

    2003-02-05

    We evaluated the relationship between the degree of heparin anticoagulation and clinical efficacy and bleeding in patients undergoing contemporary percutaneous coronary intervention (PCI) with stent implantation. Despite universal acceptance of heparin anticoagulation as a standard of care in PCI, considerable controversy still exists regarding the appropriate dosing of heparin. The study population (n = 2,064) comprised all patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. The index activated clotting time (ACT) was defined as the ACT measured after the last heparin dose and before first device activation and was correlated with outcome and bleeding events. No association was observed between decreasing ACT levels and the rate of ischemic events in the treatment or placebo arms. The incidence of the primary composite end point (death, myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy at 48 h) was actually lowest in the lowest ACT tertile for both the placebo (10.0%) and treatment groups (6.1%). When analyzed by tertile, major bleeding rates did not increase in the lowest ACT tertile in patients given placebo (0.6%) versus those receiving eptifibatide (0.7%). Major bleeding rates increased as the ACT increased in the eptifibatide-treated patients. Ischemic end points in patients undergoing contemporary PCI with stent placement do not increase by decreasing ACT levels, at least to a level of 200 s. Bleeding events do increase with increasing ACT levels and are enhanced with eptifibatide treatment. An ACT of 200 to 250 s is reasonable in terms of efficacy and safety with the use of contemporary technology and pharmacotherapy.

  2. The effect of acupuncture on psychosocial outcomes for women experiencing infertility: a pilot randomized controlled trial.

    Science.gov (United States)

    Smith, Caroline A; Ussher, Jane M; Perz, Janette; Carmady, Bridget; de Lacey, Sheryl

    2011-10-01

    The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress. The study design was a randomized controlled trial of acupuncture compared with a wait-list control. The study was conducted at The University of Western Sydney. Thirty-two (32) women aged 20-45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study. Women received six sessions of acupuncture over 8 weeks. The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] -3.75, 95% confidence interval [CI] -7.58 to 0.84, p=0.05), and less relationship concern (MD -3.66, 95% CI -6.80 to -0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI -2.20 to 26.0, p=0.09) and less anxiety (MD -2.54, 95% CI -5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

  3. Achieved Blood Pressure and Outcomes in the Secondary Prevention of Small Subcortical Strokes Trial.

    Science.gov (United States)

    Odden, Michelle C; McClure, Leslie A; Sawaya, B Peter; White, Carole L; Peralta, Carmen A; Field, Thalia S; Hart, Robert G; Benavente, Oscar R; Pergola, Pablo E

    2016-01-01

    Studies suggest a J-shaped association between blood pressure and cardiovascular events in the setting of intensive systolic blood pressure control; whether there is a similar association with stroke remains less well established. The Secondary Prevention of Small Subcortical Strokes was a randomized trial to evaluate higher (130-149 mm Hg) versus lower (blood pressure targets in participants with recent lacunar infarcts. We evaluated the association of mean achieved blood pressure, 6 months after randomization, and recurrent stroke, major vascular events, and all-cause mortality. After a mean follow up of 3.7 years, there was a J-shaped association between achieved blood pressure and outcomes; the lowest risk was at ≈124 and 67 mm Hg systolic and diastolic blood pressure, respectively. For example, above a systolic blood pressure of 124 mm Hg, 1 standard deviation higher (11.1 mm Hg) was associated with increased mortality (adjusted hazard ratio: 1.9; 95% confidence interval: 1.4, 2.7), whereas below this level, this relationship was inverted (0.29; 0.10, 0.79), Pblood pressure of 67 mm Hg, a 1 standard deviation higher (8.2 mm Hg) was associated with an increased risk of stroke (2.2; 1.4, 3.6), whereas below this level, the association was in the opposite direction (0.34; 0.13, 0.89), P=0.02 for interaction. The lowest risk of all events occurred at a nadir of ≈120 to 128 mm Hg systolic blood pressure and 65 to 70 mm Hg diastolic blood pressure. Future studies should evaluate the impact of excessive blood pressure reduction, especially in older populations with preexisting vascular disease. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059306. © 2015 American Heart Association, Inc.

  4. Evaluation of Visual Field and Imaging Outcomes for Glaucoma Clinical Trials (An American Ophthalomological Society Thesis).

    Science.gov (United States)

    Garway-Heath, David F; Quartilho, Ana; Prah, Philip; Crabb, David P; Cheng, Qian; Zhu, Haogang

    2017-08-01

    To evaluate the ability of various visual field (VF) analysis methods to discriminate treatment groups in glaucoma clinical trials and establish the value of time-domain optical coherence tomography (TD OCT) imaging as an additional outcome. VFs and retinal nerve fibre layer thickness (RNFLT) measurements (acquired by TD OCT) from 373 glaucoma patients in the UK Glaucoma Treatment Study (UKGTS) at up to 11 scheduled visits over a 2 year interval formed the cohort to assess the sensitivity of progression analysis methods. Specificity was assessed in 78 glaucoma patients with up to 11 repeated VF and OCT RNFLT measurements over a 3 month interval. Growth curve models assessed the difference in VF and RNFLT rate of change between treatment groups. Incident progression was identified by 3 VF-based methods: Guided Progression Analysis (GPA), 'ANSWERS' and 'PoPLR', and one based on VFs and RNFLT: 'sANSWERS'. Sensitivity, specificity and discrimination between treatment groups were evaluated. The rate of VF change was significantly faster in the placebo, compared to active treatment, group (-0.29 vs +0.03 dB/year, P <.001); the rate of RNFLT change was not different (-1.7 vs -1.1 dB/year, P =.14). After 18 months and at 95% specificity, the sensitivity of ANSWERS and PoPLR was similar (35%); sANSWERS achieved a sensitivity of 70%. GPA, ANSWERS and PoPLR discriminated treatment groups with similar statistical significance; sANSWERS did not discriminate treatment groups. Although the VF progression-detection method including VF and RNFLT measurements is more sensitive, it does not improve discrimination between treatment arms.

  5. Five-Week Outcomes From a Dosing Trial of Therapeutic Massage for Chronic Neck Pain

    Science.gov (United States)

    Sherman, Karen J.; Cook, Andrea J.; Wellman, Robert D.; Hawkes, Rene J.; Kahn, Janet R.; Deyo, Richard A.; Cherkin, Daniel C.

    2014-01-01

    PURPOSE This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0–50 points) and pain intensity with a numerical rating scale (range, 0–10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment. PMID:24615306

  6. Serum Potassium Levels and Outcome in Acute Heart Failure (Data from the PROTECT and COACH Trials).

    Science.gov (United States)

    Tromp, Jasper; Ter Maaten, Jozine M; Damman, Kevin; O'Connor, Christopher M; Metra, Marco; Dittrich, Howard C; Ponikowski, Piotr; Teerlink, John R; Cotter, Gad; Davison, Beth; Cleland, John G F; Givertz, Michael M; Bloomfield, Daniel M; van der Wal, Martje H L; Jaarsma, Tiny; van Veldhuisen, Dirk J; Hillege, Hans L; Voors, Adriaan A; van der Meer, Peter

    2017-01-15

    Serum potassium is routinely measured at admission for acute heart failure (AHF), but information on association with clinical variables and prognosis is limited. Potassium measurements at admission were available in 1,867 patients with AHF in the original cohort of 2,033 patients included in the Patients Hospitalized with acute heart failure and Volume Overload to Assess Treatment Effect on Congestion and Renal FuncTion trial. Patients were grouped according to low potassium (5.0 mEq/l) levels. Results were verified in a validation cohort of 1,023 patients. Mean age of patients was 71 ± 11 years, and 66% were men. Low potassium was present in 115 patients (6%), normal potassium in 1,576 (84%), and high potassium in 176 (9%). Potassium levels increased during hospitalization (0.18 ± 0.69 mEq/l). Patients with high potassium more often used angiotensin-converting enzyme inhibitors and mineralocorticoid receptor antagonists before admission, had impaired baseline renal function and a better diuretic response (p = 0.005), independent of mineralocorticoid receptor antagonist usage. During 180-day follow-up, a total of 330 patients (18%) died. Potassium levels at admission showed a univariate linear association with mortality (hazard ratio [log] 2.36, 95% confidence interval 1.07 to 5.23; p = 0.034) but not after multivariate adjustment. Changes of potassium levels during hospitalization or potassium levels at discharge were not associated with outcome after multivariate analysis. Results in the validation cohort were similar to the index cohort. In conclusion, high potassium levels at admission are associated with an impaired renal function but a better diuretic response. Changes in potassium levels are common, and overall levels increase during hospitalization. In conclusion, potassium levels at admission or its change during hospitalization are not associated with mortality after multivariate adjustment. Copyright © 2016 The Authors. Published by Elsevier Inc

  7. Adding methylphenidate to prism-adaptation improves outcome in neglect patients. A randomized clinical trial.

    Science.gov (United States)

    Luauté, Jacques; Villeneuve, Laurent; Roux, Adeline; Nash, Stuart; Bar, Jean-Yves; Chabanat, Eric; Cotton, François; Ciancia, Sophie; Sancho, Pierre-Olivier; Hovantruc, Patrick; Quelard, François; Sarraf, Thierry; Cojan, Yann; Hadj-Bouziane, Fadila; Farné, Alessandro; Janoly-Dumenil, Audrey; Boisson, Dominique; Jacquin-Courtois, Sophie; Rode, Gilles; Rossetti, Yves

    2018-04-04

    Spatial neglect is one of the main predictors of poor functional recovery after stroke. Many therapeutic interventions have been developed to alleviate this condition, but to date the evidence of their effectiveness is still scarce. The purpose of this study was to test whether combining prism adaptation (PA) and methylphenidate (MP) could enhance the recovery of neglect patients at a functional level. RITAPRISM is a multicentre, randomized, double-blind, placebo-controlled study comparing PA plus placebo (control) versus PA plus MP. 24 patients were prospectively enrolled (10 in the placebo group and 14 in the MP group). The main result is a long-term functional improvement (on the functional independence measure (FIM) and on Bergego's scale) induced by MP combined with PA. No serious adverse event occurred. The long-term benefit on activities of daily living (ADL) obtained in this randomized controlled trial set this intervention apart from previous attempts and supports with a high level of evidence the value of combining PA and MP in order to improve the autonomy of neglect patients. Further studies will be needed to clarify the mechanism of this improvement. Although not specifically assessed at this stage, a part of the improvement in ADL might be related to the collateral effect of MP on mood, executive functions or fatigue, and/or the combined effect of PA and MP on motor intentional bias of neglect patients. This study provides Class I evidence that adding MP to PA improves the functional outcome of neglect patients. EUCTR2008-000325-20-FR. Copyright © 2018 Elsevier Ltd. All rights reserved.

  8. Ankle-brachial index and cardiovascular outcomes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

    Science.gov (United States)

    Abbott, J Dawn; Lombardero, Manuel S; Barsness, Gregory W; Pena-Sing, Ivan; Buitrón, L Virginia; Singh, Premranjan; Woodhead, Gail; Tardif, Jean-Claude; Kelsey, Sheryl F

    2012-10-01

    Peripheral arterial disease increases cardiovascular risk in many patient populations. The risks associated with an abnormal ankle-brachial index (ABI) in patients with type 2 diabetes and stable coronary artery disease have not been well described with respect to thresholds and types of cardiovascular events. We examined 2,368 patients in the BARI 2D trial who underwent ABI assessment at baseline. Death and major cardiovascular events (death, myocardial infarction and stroke) during follow-up (average 4.3 years) were assessed across the ABI spectrum and by categorized ABI: low (≤0.90), normal (0.91-1.3), high (>1.3), or noncompressible. A total of 12,568 person-years were available for mortality analysis. During follow-up, 316 patients died, and 549 had major cardiovascular events. After adjustment for potential confounders, with normal ABI as the referent group, a low ABI conferred an increased risk of death (relative risk [RR] 1.6, CI 1.2-2.2, P = .0005) and major cardiovascular events (RR 1.4, CI 1.1-1.7, P = .004). Patients with a high ABI had similar outcomes as patients with a normal ABI, but risk again increased in patients with a noncompressible ABI with a risk of death (RR 1.9, CI 1.3-2.8, P = .001) and major cardiovascular event (RR 1.5, CI 1.1-2.1, P = .01). In patients with coronary artery disease and type 2 diabetes, ABI screening and identification of ABI abnormalities including a low ABI (<1.0) or noncompressible artery provide incremental prognostic information. Copyright © 2012 Mosby, Inc. All rights reserved.

  9. The influence of cold pack on labour pain relief and birth outcomes: a randomised controlled trial.

    Science.gov (United States)

    Shirvani, Marjan Ahmad; Ganji, Zhila

    2014-09-01

    (1) To evaluate the influence of local cold on severity of labour pain and (2) to identify the effect of local cold on maternal and neonatal outcomes. Fear of labour pain results in an increase in pain and duration of labour, maternal discontent and demand for caesarean section. Regarding maternal and foetal complications of analgesic medications, the attention to application of nonpharmacological methods including cold therapy is increased. Randomised controlled trial. Sixty-four pregnant women, at initiation of active phase of labour, were allocated randomly to cold therapy and control groups (n = 64). Null parity, term pregnancy, presence of single foetus, cephalic presentation and completing informed consent were considered as inclusion criteria. Administration of analgesic and anaesthesia, foetal distress, skin lesions in regions of cold therapy and high-risk pregnancy provided exclusion criteria. Cold pack was applied over abdomen and back, for 10 minutes every 30 minutes during first phase of labour. Additionally, cold pack was placed over perineum, for 5 minutes every 15 minutes during second phase. Pain severity was assessed based on the visual analogue scale. The two groups were not significantly different considering demographic data, gestational age, foetal weight, rupture of membranes and primary severity of pain. Degree of pain was lower in cold therapy group during all parts of active phase and second stage. Duration of all phases was shorter in cold therapy group in all phases. Foetal heart rate, perineal laceration, type of birth, application of oxytocin and APGAR score were not significantly different between two groups. Labour pain is probably reduced based on gate theory using cold. Pain control by cold maybe improves labour progression without affecting mother and foetus adversely. Local cold therapy could be included in labour pain management. © 2013 John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    Orton Jane

    2009-12-01

    Full Text Available Abstract Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm ( Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651

  11. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials.

    Science.gov (United States)

    Cortese, Samuele; Ferrin, Maite; Brandeis, Daniel; Holtmann, Martin; Aggensteiner, Pascal; Daley, David; Santosh, Paramala; Simonoff, Emily; Stevenson, Jim; Stringaris, Argyris; Sonuga-Barke, Edmund J S

    2016-06-01

    We performed meta-analyses of randomized controlled trials to examine the effects of neurofeedback on attention-deficit/hyperactivity disorder (ADHD) symptoms and neuropsychological deficits in children and adolescents with ADHD. We searched PubMed, Ovid, Web of Science, ERIC, and CINAHAL through August 30, 2015. Random-effects models were employed. Studies were evaluated with the Cochrane Risk of Bias tool. We included 13 trials (520 participants with ADHD). Significant effects were found on ADHD symptoms rated by assessors most proximal to the treatment setting, that is, the least blinded outcome measure (standardized mean difference [SMD]: ADHD total symptoms = 0.35, 95% CI = 0.11-0.59; inattention = 0.36, 95% CI = 0.09-0.63; hyperactivity/impulsivity = 0.26, 95% CI = 0.08-0.43). Effects were not significant when probably blinded ratings were the outcome or in trials with active/sham controls. Results were similar when only frequency band training trials, the most common neurofeedback approach, were analyzed separately. Effects on laboratory measures of inhibition (SMD = 0.30, 95% CI = -0.10 to 0.70) and attention (SMD = 0.13, 95% CI = -0.09 to 0.36) were not significant. Only 4 studies directly assessed whether learning occurred after neurofeedback training. The risk of bias was unclear for many Cochrane Risk of Bias domains in most studies. Evidence from well-controlled trials with probably blinded outcomes currently fails to support neurofeedback as an effective treatment for ADHD. Future efforts should focus on implementing standard neurofeedback protocols, ensuring learning, and optimizing clinically relevant transfer. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  12. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

    Science.gov (United States)

    Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

    2014-10-01

    The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  13. Gel versus capillary electrophoresis genotyping for categorizing treatment outcomes in two anti-malarial trials in Uganda

    OpenAIRE

    Hubbard Alan E; Dorsey Grant; Gupta Vinay; Rosenthal Philip J; Greenhouse Bryan

    2010-01-01

    Abstract Background Molecular genotyping is performed in anti-malarial trials to determine whether recurrent parasitaemia after therapy represents a recrudescence (treatment failure) or new infection. The use of capillary instead of agarose gel electrophoresis for genotyping offers technical advantages, but it is unclear whether capillary electrophoresis will result in improved classification of anti-malarial treatment outcomes. Methods Samples were genotyped using both gel and capillary elec...

  14. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C; Hobbs, Brian P; Berry, Donald A; Pentz, Rebecca D; Tam, Alda; Hong, Waun K; Ellis, Lee M; Abbruzzese, James; Overman, Michael J

    2015-11-01

    The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P medicine, additional initiatives are needed to minimize selective reporting. © 2015 by American Society of Clinical Oncology.

  15. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-12-29

    Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical

  16. Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders.

    Science.gov (United States)

    Wergeland, Gro Janne H; Fjermestad, Krister W; Marin, Carla E; Bjelland, Ingvar; Haugland, Bente Storm Mowatt; Silverman, Wendy K; Öst, Lars-Göran; Bjaastad, Jon Fauskanger; Oeding, Kristin; Havik, Odd E; Heiervang, Einar R

    2016-01-01

    A substantial number of children with anxiety disorders do not improve following cognitive behavioral therapy (CBT). Recent effectiveness studies have found poorer outcome for CBT programs than what is typically found in efficacy studies. The present study examined predictors of treatment outcome among 181 children (aged 8-15 years), with separation anxiety, social phobia, or generalized anxiety disorder, who participated in a randomized, controlled effectiveness trial of a 10-session CBT program in community clinics. Potential predictors included baseline demographic, child, and parent factors. Outcomes were as follows: a) remission from all inclusion anxiety disorders; b) remission from the primary anxiety disorder; and c) child- and parent-rated reduction of anxiety symptoms at post-treatment and at 1-year follow-up. The most consistent findings across outcome measures and informants were that child-rated anxiety symptoms, functional impairment, a primary diagnosis of social phobia or separation anxiety disorder, and parent internalizing symptoms predicted poorer outcome at post-treatment. Child-rated anxiety symptoms, lower family social class, lower pretreatment child motivation, and parent internalizing symptoms predicted poorer outcome at 1-year follow-up. These results suggest that anxious children with more severe problems, and children of parents with elevated internalizing symptom levels, may be in need of modified, additional, or alternative interventions to achieve a positive treatment outcome. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement

    OpenAIRE

    Spuls, Ph.I.; Gerbens, L.A.A.; Simpson, E.; Apfelbacher, C.J.; Chalmers, J.R.; Thomas, K.S.; Prinsen, C.A.C.; Kobyletzki, L.B. von; Singh, J.A.; Williams, Hywel C.; Schmitt, J.

    2017-01-01

    Background: The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and longterm control.\\ud Objectives: The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials.\\ud Methods: Following the HOME roa...

  18. Reporting bias inflates the reputation of medical treatments: A comparison of outcomes in clinical trials and online product reviews.

    Science.gov (United States)

    de Barra, Mícheál

    2017-03-01

    People often hold unduly positive expectations about the outcomes of medicines and other healthcare products. Here the following explanation is tested: people who have a positive outcome tend to tell more people about their disease/treatment than people with poor or average outcomes. Akin to the file drawer problem in science, this systematically and positively distorts the information available to others. If people with good treatment outcomes are more inclined to tell others, then they should also be more inclined to write online medical product reviews. Therefore, average treatment outcomes in these reviews should be more positive than those found in randomised controlled trials (RCTs). Data on duration of treatment and outcome (i.e., weight/cholesterol change) were extracted from user-generated health product reviews on Amazon.com and compared to RCT data for the same treatments using ANOVA. The sample included 1675 reviews of cholesterol reduction (Benecol, CholestOff) and weight loss (Orlistat) treatments and the primary outcome was cholesterol change (Bencol and CholestOff) or weight change (Orlistat). In three independent tests, average outcomes reported in the reviews were substantially more positive than the outcomes reported in the medical literature (η 2  = 0.01 to 0.06; p = 0.04 to 0.001). For example, average cholesterol change following use of Benecol is -14 mg/dl in RCTs and -45 mg/dl in online reviews. People with good treatment outcomes are more inclined to share information about their treatment, which distorts the information available to others. People who rely on word of mouth reputation, electronic or real life, are likely to develop unduly positive expectations. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  19. Choice of design and outcomes in trials among children with moderate acute malnutrition

    DEFF Research Database (Denmark)

    Friis, Henrik; Michaelsen, Kim F.; Wells, Jonathan C

    2015-01-01

    There is a need for trials on the effects of food aid products for children with moderate acute malnutrition, to identify how best to restore body tissues and function. The choice of control intervention is a major challenge, with both ethical and scientific implications. While randomized trials...

  20. Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wake Melissa

    2012-07-01

    Full Text Available Abstract Background Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1 if it improves language and associated outcomes at ages 5 and 6 years and (2 its cost-effectiveness for families and the health care system. Methods/Design A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or ‘usual care’ control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a ‘step up-step down’ therapeutic approach depending on the child’s language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills. Discussion A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised

  1. Voice and swallowing outcomes of an organ-preservation trial for advanced laryngeal cancer

    International Nuclear Information System (INIS)

    Fung, Kevin; Lyden, Teresa H.; Lee, Julia; Urba, Susan G.; Worden, Frank; Eisbruch, Avraham; Tsien, Christina; Bradford, Carol R.; Chepeha, Douglas B.; Hogikyan, Norman D.; Prince, Mark E.P.; Teknos, Theodoros N.; Wolf, Gregory T.

    2005-01-01

    Introduction: Organ-preservation treatment approaches for advanced laryngeal cancer patients that use combination chemoradiotherapy result in cure rates similar to primary laryngectomy with postoperative radiotherapy. In the national VA Larynx Cancer Trial, successful organ preservation was associated with an overall improvement in quality of life but not in subjective speech compared with long-term laryngectomy survivors. As part of a Phase II clinical trial, a prospective study of speech and swallowing results was conducted to determine if larynx preservation is associated with improved voice and swallowing compared with results in patients who require salvage laryngectomy. Subjects: A total of 97 patients with advanced laryngeal cancer (46 Stage III, 51 Stage IV) were given a single course of induction chemotherapy (cisplatin 100 mg/m 2 on Day 1 and 5-FU 1,000 mg/m 2 /day x 5 days), followed by assessment of response. Patients with less than 50% response underwent early salvage laryngectomy, and patients with 50% or better response underwent concurrent chemoradiation (72 Gy and cisplatin 100 mg/m 2 on Days 1, 22, and 43), followed by two cycles of adjuvant chemotherapy (DDP/5-FU). Direct laryngoscopy and biopsy were performed 8 weeks after radiation therapy to determine final tumor response. Late salvage surgery was performed on patients with persistent or recurrent disease. Methods: Completed survey data on voice and swallowing utilizing the Voice-Related Quality of Life Measure (V-RQOL) and the List Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) were obtained from 56 patients who were alive and free of disease at the time of survey, with a minimum follow-up of 8 months. Comparisons were made between patients with an intact larynx (n = 37) vs. laryngectomy (n = 19), as well as early (n = 12) vs. late salvage laryngectomy (n = 7). Multivariate analysis was performed to determine factors predictive of voice and swallowing outcomes. Overall 3

  2. Gel versus capillary electrophoresis genotyping for categorizing treatment outcomes in two anti-malarial trials in Uganda

    Directory of Open Access Journals (Sweden)

    Hubbard Alan E

    2010-01-01

    Full Text Available Abstract Background Molecular genotyping is performed in anti-malarial trials to determine whether recurrent parasitaemia after therapy represents a recrudescence (treatment failure or new infection. The use of capillary instead of agarose gel electrophoresis for genotyping offers technical advantages, but it is unclear whether capillary electrophoresis will result in improved classification of anti-malarial treatment outcomes. Methods Samples were genotyped using both gel and capillary electrophoresis from randomized trials of artemether-lumefantrine (AL vs. dihydroartemisinin-piperaquine (DP performed in two areas of Uganda: Kanungu, where transmission is moderate, and Apac, where transmission is very high. Both gel and capillary methods evaluated polymorphic regions of the merozoite surface protein 1 and 2 and glutamine rich protein genes. Results Capillary electrophoresis detected more alleles and provided higher discriminatory power than agarose gel electrophoresis at both study sites. There was only moderate agreement between classification of outcomes with the two methods in Kanungu (kappa = 0.66 and poor agreement in Apac (kappa = 0.24. Overall efficacy results were similar when using gel vs. capillary methods in Kanungu (42-day risk of treatment failure for AL: 6.9% vs. 5.5%, p = 0.4; DP 2.4% vs. 2.9%, p = 0.5. However, the measured risk of recrudescence was significantly higher when using gel vs. capillary electrophoresis in Apac (risk of treatment failure for AL: 17.0% vs. 10.7%, p = 0.02; DP: 8.5% vs. 3.4%, p = 0.03. Risk differences between AL and DP were not significantly different whether gel or capillary methods were used. Conclusions Genotyping with gel electrophoresis overestimates the risk of recrudescence in anti-malarial trials performed in areas of high transmission intensity. Capillary electrophoresis provides more accurate outcomes for such trials and should be performed when possible. In areas of moderate transmission

  3. Gel versus capillary electrophoresis genotyping for categorizing treatment outcomes in two anti-malarial trials in Uganda.

    Science.gov (United States)

    Gupta, Vinay; Dorsey, Grant; Hubbard, Alan E; Rosenthal, Philip J; Greenhouse, Bryan

    2010-01-15

    Molecular genotyping is performed in anti-malarial trials to determine whether recurrent parasitaemia after therapy represents a recrudescence (treatment failure) or new infection. The use of capillary instead of agarose gel electrophoresis for genotyping offers technical advantages, but it is unclear whether capillary electrophoresis will result in improved classification of anti-malarial treatment outcomes. Samples were genotyped using both gel and capillary electrophoresis from randomized trials of artemether-lumefantrine (AL) vs. dihydroartemisinin-piperaquine (DP) performed in two areas of Uganda: Kanungu, where transmission is moderate, and Apac, where transmission is very high. Both gel and capillary methods evaluated polymorphic regions of the merozoite surface protein 1 and 2 and glutamine rich protein genes. Capillary electrophoresis detected more alleles and provided higher discriminatory power than agarose gel electrophoresis at both study sites. There was only moderate agreement between classification of outcomes with the two methods in Kanungu (kappa = 0.66) and poor agreement in Apac (kappa = 0.24). Overall efficacy results were similar when using gel vs. capillary methods in Kanungu (42-day risk of treatment failure for AL: 6.9% vs. 5.5%, p = 0.4; DP 2.4% vs. 2.9%, p = 0.5). However, the measured risk of recrudescence was significantly higher when using gel vs. capillary electrophoresis in Apac (risk of treatment failure for AL: 17.0% vs. 10.7%, p = 0.02; DP: 8.5% vs. 3.4%, p = 0.03). Risk differences between AL and DP were not significantly different whether gel or capillary methods were used. Genotyping with gel electrophoresis overestimates the risk of recrudescence in anti-malarial trials performed in areas of high transmission intensity. Capillary electrophoresis provides more accurate outcomes for such trials and should be performed when possible. In areas of moderate transmission, gel electrophoresis appears adequate to estimate comparative

  4. Adaptive designs for dose-finding in non-cancer phase II trials: influence of early unexpected outcomes.

    Science.gov (United States)

    Resche-Rigon, Matthieu; Zohar, Sarah; Chevret, Sylvie

    2008-01-01

    In non-cancer phase II trials, dose-finding trials are usually carried out using fixed designs, in which several doses including a placebo are randomly distributed to patients. However, in certain vulnerable populations, such as neonates or infants, there is an heightened requirement for safety, precluding randomization. To estimate the minimum effective dose of a new drug from a non-cancer phase II trial, we propose the use of adaptive designs like the Continual Reassessment Method (CRM). This approach estimates the dose closest to some target response, and has been shown to be unbiased and efficient in cancer phase I trials. Based on a motivating example, we point out the individual influence of first outliers in this setting. A weighted version of the CRM is proposed as a theoretical benchmark to control for these outliers. Using simulations, we illustrate how this approach provides further insight into the behavior of the CRM. When dealing with low targets like a 10% failure rate, the CRM appears unable to rapidly overcome an early unexpected outcome. This behavior persisted despite changing the inference (Bayesian or likelihood), underlying dose-response model (though slightly improved using the power model), and the number of patients enrolled at each dose level. The choices for initial guesses of failure rates, the vague prior for the model parameter, and the log-log shape of weights can appear somewhat arbitrary. In phase II dose-finding studies in which failure targets are below 20%, the CRM appears quite sensitive to first unexpected outcomes. Using a power model for dose-response improves some behavior if the trial is started at the first dose level and includes at least three to five patients at the starting dose before applying the CRM allocation rule.

  5. EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan

    2011-09-14

    Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.

  6. Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

    Science.gov (United States)

    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

  7. The influence of dose distribution on treatment outcome in the SCOPE 1 oesophageal cancer trial

    International Nuclear Information System (INIS)

    Carrington, Rhys; Spezi, Emiliano; Gwynne, Sarah; Dutton, Peter; Hurt, Chris; Staffurth, John; Crosby, Thomas

    2016-01-01

    The first aim of this study was to assess plan quality using a conformity index (CI) and analyse its influence on patient outcome. The second aim was to identify whether clinical and technological factors including planning treatment volume (PTV) volume and treatment delivery method could be related to the CI value. By extending the original concept of the mean distance to conformity (MDC) index, the OverMDC and UnderMDC of the 95 % isodose line (50Gy prescribed dose) to the PTV was calculated for 97 patients from the UK SCOPE 1 trial (ISCRT47718479). Data preparation was carried out in CERR, with Kaplan-Meier and multivariate analysis undertaken in EUCLID and further tests in Microsoft Excel and IBM’s SPSS. A statistically significant breakpoint in the overall survival data, independent of cetuximab, was found with OverMDC (4.4 mm, p < 0.05). This was not the case with UnderMDC. There was a statistically significant difference in PTV volume either side of the OverMDC breakpoint (Mann Whitney p < 0.001) and in OverMDC value dependent on the treatment delivery method (mean IMRT = 2.1 mm, mean 3D-CRT = 4.1 mm Mann Whitney p < 0.001). Re-planning the worst performing patients according to OverMDC from 3D-CRT to VMAT resulted in a mean reduction in OverMDC of 2.8 mm (1.6–4.0 mm). OverMDC was not significant in multivariate analysis that included age, sex, staging, tumour type, and position. Although not significant when included in multivariate analysis, we have shown in univariate analysis that a patient’s OverMDC is correlated with overall survival. OverMDC is strongly related to IMRT and to a lesser extent with PTV volume. We recommend that VMAT planning should be used for oesophageal planning when available and that attention should be paid to the conformity of the 95 % to the PTV

  8. Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets.

    Science.gov (United States)

    Idzerda, Leanne; Rader, Tamara; Tugwell, Peter; Boers, Maarten

    2014-05-01

    The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of

  9. Open Access Platforms in Spinal Cord Injury: Existing Clinical Trial Data to Predict and Improve Outcomes.

    Science.gov (United States)

    Kramer, John L K; Geisler, Fred; Ramer, Leanne; Plunet, Ward; Cragg, Jacquelyn J

    2017-05-01

    Recovery from acute spinal cord injury (SCI) is characterized by extensive heterogeneity, resulting in uncertain prognosis. Reliable prediction of recovery in the acute phase benefits patients and their families directly, as well as improves the likelihood of detecting efficacy in clinical trials. This issue of heterogeneity is not unique to SCI. In fields such as traumatic brain injury, Parkinson's disease, and amyotrophic lateral sclerosis, one approach to understand variability in recovery has been to make clinical trial data widely available to the greater research community. We contend that the SCI community should adopt a similar approach in providing open access clinical trial data.

  10. Group-Sequential Strategies in Clinical Trials with Multiple Co-Primary Outcomes

    Science.gov (United States)

    Hamasaki, Toshimitsu; Asakura, Koko; Evans, Scott R; Sugimoto, Tomoyuki; Sozu, Takashi

    2015-01-01

    We discuss the decision-making frameworks for clinical trials with multiple co-primary endpoints in a group-sequential setting. The decision-making frameworks can account for flexibilities such as a varying number of analyses, equally or unequally spaced increments of information and fixed or adaptive Type I error allocation among endpoints. The frameworks can provide efficiency, i.e., potentially fewer trial participants, than the fixed sample size designs. We investigate the operating characteristics of the decision-making frameworks and provide guidance on constructing efficient group-sequential strategies in clinical trials with multiple co-primary endpoints. PMID:25844122

  11. A cluster randomized control trial to assess the impact of active learning on child activity, attention control, and academic outcomes: The Texas I-CAN trial.

    Science.gov (United States)

    Bartholomew, John B; Jowers, Esbelle M; Errisuriz, Vanessa L; Vaughn, Sharon; Roberts, Gregory

    2017-10-01

    Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Simulation-based team training for multi-professional obstetric care teams to improve patient outcome : a multicentre, cluster randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

    OBJECTIVE: To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. DESIGN: Multicentre, open, cluster randomised controlled trial. SETTING: Obstetric units in the Netherlands. POPULATION: Women with a singleton pregnancy beyond 24 weeks of

  13. Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial-rationale and study protocol.

    Science.gov (United States)

    Gaudino, Mario; Alexander, John H; Bakaeen, Faisal G; Ballman, Karla; Barili, Fabio; Calafiore, Antonio Maria; Davierwala, Piroze; Goldman, Steven; Kappetein, Peter; Lorusso, Roberto; Mylotte, Darren; Pagano, Domenico; Ruel, Marc; Schwann, Thomas; Suma, Hisayoshi; Taggart, David P; Tranbaugh, Robert F; Fremes, Stephen

    2017-12-01

    The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative

  14. Statin Therapy and Outcome After Ischemic Stroke: Systematic Review and Meta-Analysis of Observational Studies and Randomized Trials.

    LENUS (Irish Health Repository)

    2013-01-03

    Background-Although experimental data suggest that statin therapy may improve neurological outcome after acute cerebral ischemia, the results from clinical studies are conflicting. We performed a systematic review and meta-analysis investigating the relationship between statin therapy and outcome after ischemic stroke. METHODS: The primary analysis investigated statin therapy at stroke onset (prestroke statin use) and good functional outcome (modified Rankin score 0 to 2) and death. Secondary analyses included the following: (1) acute poststroke statin therapy (≤72 hours after stroke), and (2) thrombolysis-treated patients. RESULTS: The primary analysis included 113 148 subjects (27 studies). Among observational studies, statin treatment at stroke onset was associated with good functional outcome at 90 days (pooled odds ratio [OR], 1.41; 95% confidence interval [CI], 1.29-1.56; P<0.001), but not 1 year (OR, 1.12; 95% CI, 0.9-1.4; P=0.31), and with reduced fatality at 90 days (pooled OR, 0.71; 95% CI, 0.62-0.82; P<0.001) and 1 year (OR, 0.80; 95% CI, 0.67-0.95; P=0.01). In the single randomized controlled trial reporting 90-day functional outcome, statin treatment was associated with good outcome (OR, 1.5; 95% CI, 1.0-2.24; P=0.05). No reduction in fatality was observed on meta-analysis of data from 3 randomized controlled trials (P=0.9). In studies of thrombolysis-treated patients, an association between statins and increased fatality at 90 days was observed (pooled OR, 1.25; 95% CI, 1.02-1.52; P=0.03, 3 studies, 4339 patients). However, this association was no longer present after adjusting for age and stroke severity in the largest study (adjusted OR, 1.14; 95% CI, 0.90-1.44; 4012 patients). CONCLUSIONS: In the largest meta-analysis to date, statin therapy at stroke onset was associated with improved outcome, a finding not observed in studies restricted to thrombolysis-treated patients. Randomized trials of statin therapy in acute ischemic stroke are needed.

  15. Trial to assess the utility of genetic sequencing to improve patient outcomes

    Science.gov (United States)

    A pilot trial to assess whether assigning treatment based on specific gene mutations can provide benefit to patients with metastatic solid tumors is being launched this month by the NCI. The Molecular Profiling based Assignment of Cancer Therapeutics, or

  16. Methodological issues in systematic reviews of headache trials: adapting historical diagnostic classifications and outcome measures to present-day standards.

    Science.gov (United States)

    McCrory, Douglas C; Gray, Rebecca N; Tfelt-Hansen, Peer; Steiner, Timothy J; Taylor, Frederick R

    2005-05-01

    Recent efforts to make headache diagnostic classification and clinical trial methodology more consistent provide valuable advice to trialists generating new evidence on effectiveness of treatments for headache; however, interpreting older trials that do not conform to new standards remains problematic. Systematic reviewers seeking to utilize historical data can adapt currently recommended diagnostic classification and clinical trial methodological approaches to interpret all available data relative to current standards. In evaluating study populations, systematic reviewers can: (i) use available data to attempt to map study populations to diagnoses in the new International Classification of Headache Disorders; and (ii) stratify analyses based on the extent to which study populations are precisely specified. In evaluating outcome measures, systematic reviewers can: (i) summarize prevention studies using headache frequency, incorporating headache index in a stratified analysis if headache frequency is not available; (ii) summarize acute treatment studies using pain-free response as reported in directly measured headache improvement or headache severity outcomes; and (iii) avoid analysis of recurrence or relapse data not conforming to the sustained pain-free response definition.

  17. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.

    2008-01-01

    human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity......, uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy. CONCLUSIONS: The OPPORTUNITY Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers...

  18. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

    Science.gov (United States)

    Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

    2018-02-06

    Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n

  19. Predictors of the sex offender civil commitment trial outcomes in New York State.

    Science.gov (United States)

    Lu, Yunmei; Freeman, Naomi J; Sandler, Jeffrey C

    2015-10-01

    The present study analyzed sex offender civil management (i.e., civil commitment) legal proceedings in New York State and identified factors that predict trial results. Specifically, the current study compared a sample of 38 sex offenders who were released to the community after winning their civil management trials to 183 sex offenders who lost their civil management trials. Additionally, for the 183 sex offenders who lost their civil management trials, the current study compared 146 offenders who were ordered to inpatient civil commitment to 37 offenders who were deemed fit for civil management in the community. Results of the analyses indicated that sexual criminality, sexual deviance, and criminality involving child victims increased the likelihood of offenders both losing their civil management trial and being found to be in need of inpatient care, while the presence of variables associated with nonsexual criminality increased the likelihood of offenders both winning their civil management trials and being deemed fit for management in the community. The findings of this study provide guidance for psychiatric examiners who testify in civil management legal proceedings, as well as for legal professionals specializing in civil management cases. (c) 2015 APA, all rights reserved).

  20. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    OpenAIRE

    Eisenstein, Eric L.; Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

  1. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Evelyn Korkor Ansah

    2009-01-01

    Full Text Available Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly.2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used services more frequently than those in

  2. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial

    Directory of Open Access Journals (Sweden)

    Rubneide Barreto Silva Gallo

    2018-01-01

    Trial registration: NCT01389128. [Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM (2018 Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. Journal of Physiotherapy 64: 33–40

  3. A randomized clinical trial of manual therapy and physiotherapy for persistent back and neck complaints : Subgroup analysis and relationship between outcome measures

    NARCIS (Netherlands)

    Koes, B. W.; Bouter, L. M.; Van Mameren, H.; Essers, A. H M; Verstegen, G. J M G; Hofhuizen, D. M.; Houben, J. P.; Knipschild, P. G.

    1993-01-01

    Objective: To study the efficacy of manual therapy and physiotherapy in subgroups of patients with persistent back and neck complaints. The second objective was to determine the correlation between three important outcome measures used in this trial. Design: Randomized clinical trial (subgroup

  4. Pain scoring in endometriosis: entry criteria and outcome measures for clinical trials. Report from the Art and Science of Endometriosis meeting

    OpenAIRE

    Vincent, Katy; Kennedy, Stephen; Stratton, Pamela

    2008-01-01

    Standardized entry criteria and outcome measures for clinical trials in endometriosis-related pain would facilitate the comparison of trial results and the production of systematic reviews, improving evidence-based practice in this area. This report summarizes the recommendations from an international meeting for these criteria.

  5. Secondary Prevention of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus: International Insights From the TECOS Trial (Trial Evaluating Cardiovascular Outcomes With Sitagliptin).

    Science.gov (United States)

    Pagidipati, Neha J; Navar, Ann Marie; Pieper, Karen S; Green, Jennifer B; Bethel, M Angelyn; Armstrong, Paul W; Josse, Robert G; McGuire, Darren K; Lokhnygina, Yuliya; Cornel, Jan H; Halvorsen, Sigrun; Strandberg, Timo E; Delibasi, Tuncay; Holman, Rury R; Peterson, Eric D

    2017-09-26

    Intensive risk factor modification significantly improves outcomes for patients with diabetes mellitus and cardiovascular disease. However, the degree to which secondary prevention treatment goals are achieved in international clinical practice is unknown. Attainment of 5 secondary prevention parameters-aspirin use, lipid control (low-density lipoprotein cholesterol diabetes mellitus and known cardiovascular disease at entry into TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). Logistic regression was used to evaluate the association between individual and regional factors and secondary prevention achievement at baseline. Cox proportional hazards regression analysis was used to determine the association between baseline secondary prevention achievement and cardiovascular death, myocardial infarction, or stroke. Overall, 29.9% of patients with diabetes mellitus and cardiovascular disease achieved all 5 secondary prevention parameters at baseline, although 71.8% achieved at least 4 parameters. North America had the highest proportion (41.2%), whereas Western Europe, Eastern Europe, and Latin America had proportions of ≈25%. Individually, blood pressure control (57.9%) had the lowest overall attainment, whereas nonsmoking status had the highest (89%). Over a median 3.0 years of follow-up, a higher baseline secondary prevention score was associated with improved outcomes in a step-wise graded relationship (adjusted hazard ratio, 0.60; 95% confidence interval, 0.47-0.77 for those patients achieving all 5 measures versus those achieving ≤2). In an international trial population, significant opportunities exist to improve the quality of cardiovascular secondary prevention care among patients with diabetes mellitus and cardiovascular disease, which in turn could lead to reduced risk of downstream cardiovascular events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00790205. © 2017 American Heart Association, Inc.

  6. Unconditional cash transfers for clinical and economic outcomes among HIV-affected Ugandan households: a bayesian randomised trial.

    Science.gov (United States)

    Mills, Edward J; Adhvaryu, Achyuta; Jakiela, Pamela; Birungi, Josephine; Okoboi, Stephen; Chimulwa, Teddy; Wangisi, Jonathan; Achilla, Tina; Popoff, Evan; Golchi, Shirin; Karlan, Dean

    2018-05-28

    HIV infection has profound clinical and economic costs at the household level. This is particularly important in low-income settings, where access to additional sources of income or loans may be limited. While several microfinance interventions have been proposed, unconditional cash grants, a strategy to allow participants to choose how to use finances that may improve household security and health, has not previously been evaluated. We examined the effect of an unconditional cash transfer to HIV-infected individuals using a 2 x 2 factorial randomised trial in two rural districts in Uganda. Our primary outcomes were changes in CD4 cell count, sexual behaviors, and adherence to ART. Secondary outcomes were changes in household food security and adult mental health. We applied a Bayesian approach for our primary analysis. We randomized 2170 patients as participatants, with 1081 receiving a cash grant. We found no important intervention effects on CD4 t-cell counts between groups (mean difference [MD] 35.48, 95% Credible Interval [CrI] -59.9-1131.6), food security (odds ratio [OR] 1.22, 95% CrI: 0.47, 3.02), medication adherence (OR 3.15, 95% CrI: 0.58, 18.15), or sexual behavior (OR 0.45 95% CrI: 0.12, 1.55), or health expenditure in the previous 3 weeks (Mean Difference $2.65, 95% CrI: -9.30, 15.69). In secondary analysis, we detected an effect of mental planning on CD4 change between groups (104.2 cells, 9% CrI: 5.99, 202.16). We did not have data on viral load outcomes. Although all outcomes were associated with favorable point estimates, our trial did not demonstrate important effects of unconditional cash grants on health outcomes.

  7. Near Earth Asteroid Scout Solar Sail Engineering Development Unit Test Suite

    Science.gov (United States)

    Lockett, Tiffany Russell; Few, Alexander; Wilson, Richard

    2017-01-01

    The Near Earth Asteroid (NEA) Scout project is a 6U reconnaissance mission to investigate a near Earth asteroid utilizing an 86m(sub 2) solar sail as the primary propulsion system. This will be the largest solar sail NASA has launched to date. NEA Scout is currently manifested on the maiden voyage of the Space Launch System in 2018. In development of the solar sail subsystem, design challenges were identified and investigated for packaging within a 6U form factor and deployment in cis-lunar space. Analysis was able to capture understanding of thermal, stress, and dynamics of the stowed system as well as mature an integrated sail membrane model for deployed flight dynamics. Full scale system testing on the ground is the optimal way to demonstrate system robustness, repeatability, and overall performance on a compressed flight schedule. To physically test the system, the team developed a flight sized engineering development unit with design features as close to flight as possible. The test suite included ascent vent, random vibration, functional deployments, thermal vacuum, and full sail deployments. All of these tests contributed towards development of the final flight unit. This paper will address several of the design challenges and lessons learned from the NEA Scout solar sail subsystem engineering development unit. Testing on the component level all the way to the integrated subsystem level. From optical properties of the sail material to fold and spooling the single sail, the team has developed a robust deployment system for the solar sail. The team completed several deployments of the sail system in preparation for flight at half scale (4m) and full scale (6.8m): boom only, half scale sail deployment, and full scale sail deployment. This paper will also address expected and received test results from ascent vent, random vibration, and deployment tests.

  8. Assessment and implication of prognostic imbalance in randomized controlled trials with a binary outcome--a simulation study.

    Directory of Open Access Journals (Sweden)

    Rong Chu

    Full Text Available Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1 evaluate the probability of imbalance in a binary prognostic factor (PF between two treatment arms, (2 investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3 examine the effect of sample size (n in relation to the first two objectives.We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power.For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5 leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2, adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF.The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed.

  9. Assessment and Implication of Prognostic Imbalance in Randomized Controlled Trials with a Binary Outcome – A Simulation Study

    Science.gov (United States)

    Chu, Rong; Walter, Stephen D.; Guyatt, Gordon; Devereaux, P. J.; Walsh, Michael; Thorlund, Kristian; Thabane, Lehana

    2012-01-01

    Background Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1) evaluate the probability of imbalance in a binary prognostic factor (PF) between two treatment arms, (2) investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3) examine the effect of sample size (n) in relation to the first two objectives. Methods We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power. Results For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5) leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2), adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF. Conclusions The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed. PMID:22629322

  10. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Patja Kristiina

    2012-06-01

    Full Text Available Abstract Background The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes. Methods An open-label cluster-randomized parallel groups trial. Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses, laboratory measures from electronic medical records (EMR. A total of 2594 patients filling inclusion criteria (age 45 years or older, with type 2 diabetes, coronary artery disease or congestive heart failure, and unmet treatment goals were identified from EMRs, and 1535 patients (59% gave consent and were randomized into intervention or control arm. Final analysis included 1221 (80% participants with data on primary end-points both at entry and at end. Primary outcomes were systolic and diastolic blood pressure, serum total and LDL cholesterol concentration, waist circumference for all patients, glycated hemoglobin (HbA1c for diabetics and NYHA class in patients with congestive heart failure. The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm. Results The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48% in the intervention arm and 37% in the control arm (difference 10.8%, 95% confidence interval 1.5–19.7%. No significant differences emerged between the arms in the other primary end-points. However, the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm. Conclusions Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures. To provide substantial benefits, interventions may need to be more intensive, target specific sub-groups, and/or to be fully integrated into local health care. Trial registration

  11. Comparison of computed tomography scout based reference point localization to conventional film and axial computed tomography.

    Science.gov (United States)

    Jiang, Lan; Templeton, Alistair; Turian, Julius; Kirk, Michael; Zusag, Thomas; Chu, James C H

    2011-01-01

    Identification of source positions after implantation is an important step in brachytherapy planning. Reconstruction is traditionally performed from films taken by conventional simulators, but these are gradually being replaced in the clinic by computed tomography (CT) simulators. The present study explored the use of a scout image-based reconstruction algorithm that replaces the use of traditional film, while exhibiting low sensitivity to metal-induced artifacts that can appear in 3D CT methods. In addition, the accuracy of an in-house graphical software implementation of scout-based reconstruction was compared with seed location reconstructions for 2 phantoms by conventional simulator and CT measurements. One phantom was constructed using a planar fixed grid of 1.5-mm diameter ball bearings (BBs) with 40-mm spacing. The second was a Fletcher-Suit applicator embedded in Styrofoam (Dow Chemical Co., Midland, MI) with one 3.2-mm-diameter BB inserted into each of 6 surrounding holes. Conventional simulator, kilovoltage CT (kVCT), megavoltage CT, and scout-based methods were evaluated by their ability to calculate the distance between seeds (40 mm for the fixed grid, 30-120 mm in Fletcher-Suit). All methods were able to reconstruct the fixed grid distances with an average deviation of <1%. The worst single deviations (approximately 6%) were exhibited in the 2 volumetric CT methods. In the Fletcher-Suit phantom, the intermodality agreement was within approximately 3%, with the conventional sim measuring marginally larger distances, with kVCT the smallest. All of the established reconstruction methods exhibited similar abilities to detect the distances between BBs. The 3D CT-based methods, with lower axial resolution, showed more variation, particularly with the smaller BBs. With a software implementation, scout-based reconstruction is an appealing approach because it simplifies data acquisition over film-based reconstruction without requiring any specialized equipment

  12. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-03-01

    Full Text Available Abstract Background A growing body of research suggests that regular consumption of dairy foods may counteract obesity and other components of the metabolic syndrome. However, human intervention trials are lacking. We aimed to determine the cardiometabolic health effects of increasing the consumption of reduced fat dairy foods in adults with habitually low dairy intakes in the absence of energy restriction. Methods An intervention trial was undertaken in 61 overweight or obese adults who were randomly assigned to a high dairy diet (HD, 4 serves of reduced fat dairy/day or a low dairy control diet (LD, ≤1 serve/day for 6 months then crossed over to the alternate diet for a further 6 months. A range of anthropometric and cardiometabolic parameters including body composition, metabolic rate, blood lipids, blood pressure and arterial compliance were assessed at the end of each diet phase. Results Total energy intake was 1120 kJ/day higher during the HD phase, resulting in slight weight gain during this period. However, there were no significant differences between HD and LD in absolute measures of waist circumference, body weight, fat mass or any other cardiometabolic parameter. Conclusion Recommended intakes of reduced fat dairy products may be incorporated into the diet of overweight adults without adversely affecting markers of cardiometabolic health. Trial Registration The trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12608000538347 on 24th October, 2008.

  13. Midtrimester preterm prelabour rupture of membranes (PPROM): expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL – III trial)

    Science.gov (United States)

    2014-01-01

    Background Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. Methods/Design Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. Intervention: random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05). Discussion This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. Trial registration NTR3492 Dutch Trial Register (http://www.trialregister.nl). PMID:24708702

  14. Rethinking the dose-response relationship between usage and outcome in an online intervention for depression: randomized controlled trial.

    Science.gov (United States)

    Donkin, Liesje; Hickie, Ian B; Christensen, Helen; Naismith, Sharon L; Neal, Bruce; Cockayne, Nicole L; Glozier, Nick

    2013-10-17

    There is now substantial evidence that Web-based interventions can be effective at changing behavior and successfully treating psychological disorders. However, interest in the impact of usage on intervention outcomes has only been developed recently. To date, persistence with or completion of the intervention has been the most commonly reported metric of use, but this does not adequately describe user behavior online. Analysis of alternative measures of usage and their relationship to outcome may help to understand how much of the intervention users may need to obtain a clinically significant benefit from the program. The objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial. Cardiovascular Risk E-couch Depression Outcome (CREDO) is a randomized controlled trial evaluating an unguided Web-based program (E-couch) based on cognitive behavioral therapy and interpersonal therapy for people with depression and cardiovascular disease. In all, 280 participants in the active arm of the trial commenced the program, delivered in 12 modules containing pages of text and activities. Usage data (eg, number of log-ins, modules completed, time spent online, and activities completed) were captured automatically by the program interface. We estimated the association of these and composite metrics with the outcome of a clinically significant improvement in depression score on the Patient Health Questionnaire (PHQ-9) of ≥ 5 points. In all, 214/280 (76.4%) participants provided outcome data at the end of the 12-week period and were included in the analysis. Of these, 94 (43.9%) participants obtained clinically significant improvement. Participants logged into the program an average of 18.7 times (SD 8.3) with most (62.1%, 133/214) completing all 12 modules. Average time spent online per log-in was 17.3 minutes (SD 10.5). Participants completed an average of 9 of 18 activities available within the

  15. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial

    Directory of Open Access Journals (Sweden)

    Wouters Patrick

    2011-05-01

    Full Text Available Abstract Background Pre- and postconditioning describe mechanisms whereby short ischemic periods protect an organ against a longer period of ischemia. Interestingly, short ischemic periods of a limb, in itself harmless, may increase the ischemia tolerance of remote organs, e.g. the heart (remote conditioning, RC. Although several studies have shown reduced biomarker release by RC, a reduction of complications and improvement of patient outcome still has to be demonstrated. Atrial fibrillation (AF is one of the most common complications after coronary artery bypass graft surgery (CABG, affecting 27-46% of patients. It is associated with increased mortality, adverse cardiovascular events, and prolonged in-hospital stay. We hypothesize that remote ischemic pre- and/or post-conditioning reduce the incidence of AF following CABG, and improve patient outcome. Methods/design This study is a randomized, controlled, patient and investigator blinded multicenter trial. Elective CABG patients are randomized to one of the following four groups: 1 control, 2 remote ischemic preconditioning, 3 remote ischemic postconditioning, or 4 remote ischemic pre- and postconditioning. Remote conditioning is applied at the arm by 3 cycles of 5 minutes of ischemia and reperfusion. Primary endpoint is the incidence AF in the first 72 hours after surgery, detected using a Holter-monitor. Secondary endpoints include length-of-stay on the intensive care unit and in-hospital, and the occurrence of major adverse cardiovascular events at 30 days, 3 months and 1 year. Based on an expected incidence in the control group of 27%, 195 patients per group are needed to detect with 80% power a reduction by 45% following either pre- or postconditioning, while allowing for a 10% dropout and at an alpha of 0.05. With the combined intervention expected to be stronger, we need 75 patients in this group to detect a reduction in incidence of AF of 60%. Discussion The RICO-trial (the effect of

  16. Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sung Valerie

    2012-08-01

    Full Text Available Abstract Background Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old ( Methods/Design Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i number of episodes of infant crying/fussing per 24 hours and ii infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months; iii maternal mental health scores, iv family functioning scores, v parent quality adjusted life years scores, and vi intervention cost-effectiveness (at one and six months; and vii infant faecal microbiota diversity, viii infant faecal calprotectin levels and ix Eschericia coli load (at one month only. Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied. Discussion An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If

  17. Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial.

    Science.gov (United States)

    Bernard, Stephen A; Nguyen, Vina; Cameron, Peter; Masci, Kevin; Fitzgerald, Mark; Cooper, David J; Walker, Tony; Std, B Paramed; Myles, Paul; Murray, Lynne; David; Taylor; Smith, Karen; Patrick, Ian; Edington, John; Bacon, Andrew; Rosenfeld, Jeffrey V; Judson, Rodney

    2010-12-01

    To determine whether paramedic rapid sequence intubation in patients with severe traumatic brain injury (TBI) improves neurologic outcomes at 6 months compared with intubation in the hospital. Severe TBI is associated with a high rate of mortality and long-term morbidity. Comatose patients with TBI routinely undergo endo-tracheal intubation to protect the airway, prevent hypoxia, and control ventilation. In many places, paramedics perform intubation prior to hospital arrival. However, it is unknown whether this approach improves outcomes. In a prospective, randomized, controlled trial, we assigned adults with severe TBI in an urban setting to either prehospital rapid sequence intubation by paramedics or transport to a hospital emergency department for intubation by physicians. The primary outcome measure was the median extended Glasgow Outcome Scale (GOSe) score at 6 months. Secondary end-points were favorable versus unfavorable outcome at 6 months, length of intensive care and hospital stay, and survival to hospital discharge. A total of 312 patients with severe TBI were randomly assigned to paramedic rapid sequence intubation or hospital intubation. The success rate for paramedic intubation was 97%. At 6 months, the median GOSe score was 5 (interquartile range, 1-6) in patients intubated by paramedics compared with 3 (interquartile range, 1-6) in the patients intubated at hospital (P = 0.28).The proportion of patients with favorable outcome (GOSe, 5-8) was 80 of 157 patients (51%) in the paramedic intubation group compared with 56 of 142 patients (39%) in the hospital intubation group (risk ratio, 1.28; 95% confidence interval, 1.00-1.64; P = 0.046). There were no differences in intensive care or hospital length of stay, or in survival to hospital discharge. In adults with severe TBI, prehospital rapid sequence intubation by paramedics increases the rate of favorable neurologic outcome at 6 months compared with intubation in the hospital.

  18. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials.

    Science.gov (United States)

    Kotronoulas, Grigorios; Kearney, Nora; Maguire, Roma; Harrow, Alison; Di Domenico, David; Croy, Suzanne; MacGillivray, Stephen

    2014-05-10

    The systematic use of patient-reported outcome measures (PROMs) has been advocated as an effective way to standardize cancer practice. Yet, the question of whether PROMs can lead to actual improvements in the quality of patient care remains under debate. This review examined whether inclusion of PROM in routine clinical practice is associated with improvements in patient outcomes, processes of care, and health service outcomes during active anticancer treatment. A systematic review of five electronic databases (Medline, EMBASE, CINAHL [Cumulative Index to Nursing and Allied Health Literature], PsycINFO, and Psychology and Behavioral Sciences Collection [PBSC]) was conducted from database inception to May 2012 to locate randomized and nonrandomized controlled trials of patients receiving active anticancer treatment or supportive care irrespective of type of cancer. Based on prespecified eligibility criteria, we included 26 articles that reported on 24 unique controlled trials. Wide variability in the design and use of interventions delivered, outcomes evaluated, and cancer- and modality-specific context was apparent. Health service outcomes were only scarcely included as end points. Overall, the number of statistically significant findings were limited and PROMs' intervention effect sizes were predominantly small-to-moderate. The routine use of PROMs increases the frequency of discussion of patient outcomes during consultations. In some studies, PROMs are associated with improved symptom control, increased supportive care measures, and patient satisfaction. Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health services usage.

  19. A controlled trial of the effect of aromatherapy on birth outcomes using "Rose essential oil" inhalation and foot bath

    OpenAIRE

    Masoomeh Kheirkhah; Nassimeh Setayesh Valipour; Leila Neisani; Hamid Haghani

    2013-01-01

    Background and aim: Aromatherapy is the art and science of using essential oils extracted from aromatic plants, and is concerned with natural balance, coordination and promotion of health. This study was designed to determine the effect of "rose (Rosa damascena) essential oil" inhalation and foot bath on the improvement of maternal and neonatal health outcomes. Material and methods: This study was a randomized clinical trial, conducted on 80 primiparous women in Shahid Akbar Abadi Maternity H...

  20. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

    OpenAIRE

    Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN

    2014-01-01

    Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6?7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting par...

  1. Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients: Primary Results from the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial

    Science.gov (United States)

    Bostom, Andrew G.; Carpenter, Myra A.; Kusek, John W.; Levey, Andrew S.; Hunsicker, Lawrence; Pfeffer, Marc A.; Selhub, Jacob; Jacques, Paul F.; Cole, Edward; Gravens-Mueller, Lisa; House, Andrew A.; Kew, Clifton; McKenney, Joyce L.; Pacheco-Silva, Alvaro; Pesavento, Todd; Pirsch, John; Smith, Stephen; Solomon, Scott; Weir, Matthew

    2015-01-01

    Background Kidney transplant recipients, like other patients with chronic kidney disease (CKD), experience excess risk of cardiovascular disease (CVD) and elevated total homocysteine (tHcy) concentrations. Observational studies of patients with CKD suggest increased homocysteine is a risk factor for CVD. The impact of lowering total homocysteine (tHcy) levels in kidney transplant recipients is unknown. Methods and Results In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing tHcy concentrations reduced the rate of the primary composite arteriosclerotic CVD outcome (myocardial infarction, stroke, CVD death, resuscitated sudden death, coronary artery or renal artery revascularization, lower extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n= 547 total events; hazards ratio [95% confidence interval] = 0.99 [0.84–1.17]), or secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86–1.26]) or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93–1.43]) compared to the low dose multivitamin. Conclusions Treatment with a high dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level. PMID:21482964

  2. Bringing Astronomy Activities and Science Content to Girls Locally and Nationally: A Girl Scout and NIRCam Collaboration

    Science.gov (United States)

    Higgins, M. L.; Lebofsky, L. A.; McCarthy, D. W.; Lebofsky, N.

    2013-04-01

    In 2003, the University of Arizona's (UA) NIRCam EPO team (NASA James Webb Space Telescope's Near-Infrared Camera) and the Girl Scouts of Southern Arizona began a long-term collaboration to bring STEM and astronomy activities and concepts to adult Girl Scout volunteers and staff and, in turn, their councils and girls, i.e., to train the trainers. Nationally, our goal is to reach adult volunteers and staff in all 112 councils. To date, this program has reached nearly 240 adults from 78 councils in 41 states, DC, Guam, and Japan, bringing together adult volunteers and staff, UA graduate students, and NIRCam scientists and educators to experience Arizona's dark skies.

  3. Importance of baseline distribution of proteinuria in renal outcomes trials : Lessons from the reduction of endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study

    NARCIS (Netherlands)

    Zhang, ZX; Shahinfar, S; Keane, WF; Ramjit, D; Dickson, TZ; Gleim, GW; Mogensen, CE; de Zeeuw, D; Brenner, BM; Snapinn, SM

    A key issue in the analysis of outcome trials is the adjustment for baseline covariates that influence the primary outcome. Imbalance of an important covariate between treatment groups at baseline is of considerable concern if one treatment group is favored over another with respect to the

  4. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  5. The Effect of Intermittent Antenatal Iron Supplementation on Maternal and Infant Outcomes in Rural Viet Nam: A Cluster Randomised Trial

    Science.gov (United States)

    Hanieh, Sarah; Ha, Tran T.; Simpson, Julie A.; Casey, Gerard J.; Khuong, Nguyen C.; Thoang, Dang D.; Thuy, Tran T.; Pasricha, Sant-Rayn; Tran, Thach D.; Tuan, Tran; Dwyer, Terence; Fisher, Jane; Biggs, Beverley-Ann

    2013-01-01

    Background Anemia affects over 500 million women, and in pregnancy is associated with impaired maternal and infant outcomes. Intermittent antenatal iron supplementation is an attractive alternative to daily dosing; however, the impact of this strategy on infant outcomes remains unclear. We compared the effect of intermittent antenatal iron supplementation with daily iron supplementation on maternal and infant outcomes in rural Viet Nam. Methods and Findings This cluster randomised trial was conducted in Ha Nam province, Viet Nam. 1,258 pregnant women (<16 wk gestation) in 104 communes were assigned to daily iron–folic acid (IFA), twice weekly IFA, or twice weekly multiple micronutrient (MMN) supplementation. Primary outcome was birth weight. Mean birth weight was 3,148 g (standard deviation 416). There was no difference in the birth weights of infants of women receiving twice weekly IFA compared to daily IFA (mean difference [MD] 28 g; 95% CI −22 to 78), or twice weekly MMN compared to daily IFA (MD −36.8 g; 95% CI −82 to 8.2). At 32 wk gestation, maternal ferritin was lower in women receiving twice weekly IFA compared to daily IFA (geometric mean ratio 0.73; 95% CI 0.67 to 0.80), and in women receiving twice weekly MMN compared to daily IFA (geometric mean ratio 0.62; 95% CI 0.57 to 0.68), but there was no difference in hemoglobin levels. Infants of mothers who received twice weekly IFA had higher cognitive scores at 6 mo of age compared to those who received daily IFA (MD 1.89; 95% CI 0.23 to 3.56). Conclusions Twice weekly antenatal IFA or MMN did not produce a clinically important difference in birth weight, when compared to daily IFA supplementation. The significant improvement in infant cognitive outcomes at 6 mo of age following twice weekly antenatal IFA requires further exploration, and provides additional support for the use of intermittent, rather than daily, antenatal IFA in populations with low rates of iron deficiency. Trial registration

  6. Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

    Science.gov (United States)

    Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Henley, Jill K; Ashchyan, Hovik J; Kurta, Anastasia O; Patel, Payal M; Sheikh, Umar A; Franklin, Matthew J; Hanna, Courtney C; Chen, Brian R; Chiren, Sarah G; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Maher, Ian A; Cartee, Todd V; Sobanko, Joseph F; Alam, Murad

    2017-08-01

    Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28

  7. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong; Williams, Christopher R.; Costa, Joseph; Henderson, Randal H.

    2014-01-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes

  8. Outcomes of Vogt-Koyanagi-Harada disease: a subanalysis from a randomized clinical trial of antimetabolite therapies

    Science.gov (United States)

    Shen, Elizabeth; Rathinam, Sivakumar R.; Babu, Manohar; Kanakath, Anuradha; Thundikandy, Radhika; Lee, Salena M.; Browne, Erica N.; Porco, Travis C.; Acharya, Nisha R.

    2016-01-01

    Purpose To report outcomes of Vogt-Koyanagi-Harada (VKH) disease from a clinical trial of antimetabolite therapies. Design Subanalysis from an observer-masked randomized clinical trial for non-infectious intermediate, posterior, and pan- uveitis. Methods Setting clinical practice at Aravind Eye Hospitals, India Patient Population Forty-three of 80 patients enrolled (54%) diagnosed with VKH. Intervention Patients were randomized to either 25mg oral methotrexate weekly or 1g mycophenolate mofetil twice daily, with a corticosteroid taper. Main outcome measures Primary outcome was corticosteroid-sparing control of inflammation at 5 and 6 months. Secondary outcomes included visual acuity, central subfield thickness, and adverse events. Patients were categorized as acute (diagnosis ≤3 months prior to enrollment) or chronic (diagnosis >3 months prior to enrollment). Results Twenty-seven patients were randomized to methotrexate and 16 to mycophenolate mofetil; 30 had acute VKH. The odds of achieving corticosteroid-sparing control of inflammation with methotrexate were 2.5 times (95% CI: 0.6, 9.8; P=0.20) the odds with mycophenolate mofetil, a difference which was not statistically significant. The average improvement in visual acuity was 12.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. On average, visual acuity for patients with acute VKH improved by 14 more ETDRS letters than those with chronic VKH (P<0.001), but there was no difference in corticosteroid-sparing control of inflammation (P=0.99). All 26 eyes with a serous retinal detachment at baseline resolved, and 88% achieved corticosteroid-sparing control of inflammation. Conclusions The majority of patients treated with antimetabolites and corticosteroids were able to achieve corticosteroid-sparing control of inflammation by 6 months. Although patients with acute VKH gained more visual improvement than those with chronic VKH, this did not correspond with a higher rate of controlled inflammation. PMID

  9. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2014-03-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

  10. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C

    2017-11-14

    The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

  11. Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials.

    Science.gov (United States)

    Home, P D; Kahn, S E; Jones, N P; Noronha, D; Beck-Nielsen, H; Viberti, G

    2010-09-01

    Observational and mechanistic studies have suggested a possible relationship between treatment with metformin and decreased incidence of cancer in participants with type 2 diabetes. We extracted data for malignancies from the ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) randomised controlled clinical trials, in which the efficacy and/or safety of metformin was assessed in comparison with sulfonylureas and rosiglitazone. Neoplasm occurrences were collected as adverse events in these studies. We reviewed and re-analysed the individual participant data in both studies for serious adverse events, malignancies reported as adverse events and related neoplasms of special interest. In ADOPT, 50 participants (3.4%) on metformin and 55 (3.8%) on each of rosiglitazone and glibenclamide (known as glyburide in the USA and Canada) developed serious adverse event malignancies (excluding non-melanoma skin cancers). This corresponds to 1.03, 1.12 and 1.31 per 100 person-years, giving hazard ratios for metformin of 0.92 (95% CI 0.63-1.35) vs rosiglitazone and 0.78 (0.53-1.14) vs glibenclamide. In RECORD, on a background of sulfonylurea, 69 (6.1%) participants developed malignant neoplasms in the metformin group, compared with 56 (5.1%) in the rosiglitazone group (HR 1.22 [0.86-1.74]). On a background of metformin, 74 (6.7%) participants in the sulfonylurea group developed malignant neoplasms, compared with 57 (5.1%) in the rosiglitazone group (HR 1.33 [0.94-1.88]). The malignancy rates in these two randomised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone. However, they do not refute the possibility of a difference compared with sulfonylureas.

  12. Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial

    NARCIS (Netherlands)

    D.R. Holmes Jr (David); J.R. Granett (Jeffrey); J.J. Popma (Jeffrey); P.J. Fitzgerald (Peter); D. Fischman (David); J.J. Ferguson (James); A.M. Lincoff (Michael); S. Goldberg (Sheldon); J.A. Brinker; R. Chan; B.R. Davis (Barry); M. Poland; A.M. Zeiher (Andreas); J.T. Willerson (James); S.B. King 3rd (Spencer); L.M. Shapiro; M. Savage (Michael); J.M. Lablanche (Jean Marc); J.E. Tcheng (James); L. Grip (Lars); P.W.J.C. Serruys (Patrick)

    2002-01-01

    textabstractBACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral

  13. Clinical Outcomes with β-blockers for Myocardial Infarction A Meta-Analysis of Randomized Trials

    DEFF Research Database (Denmark)

    Bangalore, Sripal; Makani, Harikrishna; Radford, Martha

    2014-01-01

    BACKGROUND: Debate exists regarding the efficacy of â-blockers in myocardial infarction and their required duration of usage in contemporary practice. METHODS: We conducted a MEDLINE/EMBASE/CENTRAL search for randomized trials evaluating â-blockers in myocardial infarction enrolling at least 100 ...

  14. The Effects of Discrete-Trial Training Commission Errors on Learner Outcomes: An Extension

    Science.gov (United States)

    Jenkins, Sarah R.; Hirst, Jason M.; DiGennaro Reed, Florence D.

    2015-01-01

    We conducted a parametric analysis of treatment integrity errors during discrete-trial training and investigated the effects of three integrity conditions (0, 50, or 100 % errors of commission) on performance in the presence and absence of programmed errors. The presence of commission errors impaired acquisition for three of four participants.…

  15. Successful Outcomes from a Structured Curriculum Used in the Veterans Affairs Low Vision Intervention Trial

    Science.gov (United States)

    Stelmack, Joan A.; Rinne, Stephen; Mancil, Rickilyn M.; Dean, Deborah; Moran, D'Anna; Tang, X. Charlene; Cummings, Roger; Massof, Robert W.

    2008-01-01

    A low vision rehabilitation program with a structured curriculum was evaluated in a randomized controlled trial. The treatment group demonstrated large improvements in self-reported visual function (reading, mobility, visual information processing, visual motor skills, and overall). The team approach and the protocols of the treatment program are…

  16. FIFTEEN-YEAR RADIOTHERAPY OUTCOMES OF THE RANDOMIZED PORTEC-1 TRIAL FOR ENDOMETRIAL CARCINOMA

    NARCIS (Netherlands)

    Creutzberg, Carien L.; Nout, Remi A.; Lybeert, Marnix L. M.; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Mens, Jan-Willem M.; Lutgens, Ludy C. H. W.; Pras, Elisabeth; van de Poll-Franse, Lonneke V.; van Putten, Wim L. J.

    2011-01-01

    Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second

  17. Prostate Cancer: Prognostic factors, markers of outcome and design of clinical trials

    NARCIS (Netherlands)

    L.A.J. Collette (Lau)

    2006-01-01

    textabstractPhase III clinical trials to assess the clinical benefit of new treatment options often require large patient numbers and long follow-up, in particular in diseases with a long natural history, such as prostate cancer. In this thesis, we argue that in order to improve the efficiency of

  18. Follow-Up of the Cues and Care Trial: Mother and Infant Outcomes at 6 Months

    Science.gov (United States)

    Feeley, Nancy; Zelkowitz, Phyllis; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

    2012-01-01

    The long-term effects of the Cues intervention to reduce anxiety and enhance the interactive behavior of mothers of very low birth weight (VLBW) infants were investigated. A randomized trial comparing the Cues intervention to an attention control condition was conducted. A total of 122 mothers of newborns weighing less than 1,500 g were…

  19. Analysis of patient-reported outcomes from the LUME-Lung 1 trial

    DEFF Research Database (Denmark)

    Novello, Silvia; Kaiser, Rolf; Mellemgaard, Anders

    2015-01-01

    INTRODUCTION: The LUME-Lung 1 trial (NCT00805194; Study 1199.13) demonstrated a significant overall survival (OS) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and adenocarcinoma...

  20. The effect of funding sources on donepezil randomised controlled trial outcome: a meta-analysis.

    Science.gov (United States)

    Killin, Lewis O J; Russ, Tom C; Starr, John M; Abrahams, Sharon; Della Sala, Sergio

    2014-04-07

    To investigate whether there is a difference in the treatment effect of donepezil on cognition in Alzheimer disease between industry-funded and independent randomised controlled trials. Fixed effects meta-analysis of standardised effects of donepezil on cognition as measured by the Mini Mental State Examination and the Alzheimer's Disease Assessment Scale-cognitive subscale. Studies included in the meta-analyses reported in the National Institute for Health and Care Excellence (NICE) technical appraisal 217 updated with new studies through a PubMed search. Inclusion criteria were double-blind, placebo-controlled trials of any length comparing patients diagnosed with probable Alzheimer disease (according to the NINCDS-ADRDA/DSM-III/IV criteria) taking any dosage of donepezil. Studies of combination therapies (eg, donepezil and memantine) were excluded, as were studies that enrolled patients with a diagnosis of Alzheimer disease associated with other disorders (eg, Parkinson's disease and Down's syndrome). Our search strategy identified 14 relevant trials (4 independent) with suitable data. Trials sponsored by pharmaceutical companies reported a larger effect of donepezil on standardised cognitive tests than trials published by independent research groups (standardised mean difference (SMD)=0.46, 95% CI 0.37 to 0.55 vs SMD=0.33, 95% CI 0.18 to 0.48, respectively). This difference remained when only data representing change up to 12 weeks from baseline were analysed (industry SMD=0.44, 95% CI 0.34 to 0.53 vs independent SMD=0.35, 95% CI 0.18 to 0.52). Analysis revealed that the effect of funding as a moderator variable of study heterogeneity was not statistically significant at either time point. The effect size of donepezil on cognition is larger in industry-funded than independent trials and this is not explained by the longer duration of industry-funded trials. The lack of a statistically significant moderator effect may indicate that the differences are due to

  1. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

    Science.gov (United States)

    Ma, Christopher; Panaccione, Remo; Fedorak, Richard N; Parker, Claire E; Khanna, Reena; Levesque, Barrett G; Sandborn, William J; Feagan, Brian G; Jairath, Vipul

    2017-06-09

    Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve

  2. A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes

    DEFF Research Database (Denmark)

    Byrne, Molly; O'Connell, Anthony; Egan, Aoife M

    2017-01-01

    two online surveys to a sample of international key stakeholders. Participants in the first survey (survey 1; n = 132) and the second survey (survey 2; n = 81) rated the importance of the outcomes. Survey 2 participants received information on total mean rating for each outcome and a reminder...... that 70% of consensus group participants voted for their inclusion. RESULTS: Eight core outcomes were agreed for inclusion in the final COS: measures of diabetes-related stress; diabetes-related quality of life; number of severe hypoglycaemic events; self-management behaviour; number of instances...... of this COS will improve the quality of future research and increase opportunities for evidence synthesis. Future research is necessary to identify the most robust outcome measure instruments....

  3. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.

    2008-01-01

    of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

  4. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes

    DEFF Research Database (Denmark)

    Wood, Lesley; Egger, Matthias; Gluud, Lise Lotte

    2008-01-01

    To examine whether the association of inadequate or unclear allocation concealment and lack of blinding with biased estimates of intervention effects varies with the nature of the intervention or outcome....

  5. Does the rising placebo response impact antihypertensive clinical trial outcomes? An analysis of data from the Food and Drug Administration 1990-2016

    Science.gov (United States)

    Fahl Mar, Kaysee; Schilling, Joshua; Brown, Walter A.

    2018-01-01

    Background Recent studies show that placebo response has grown significantly over time in clinical trials for antidepressants, ADHD medications, antiepileptics, and antidiabetics. Contrary to expectations, trial outcome measures and success rates have not been impacted. This study aimed to see if this trend of increasing placebo response and stable efficacy outcome measures is unique to the conditions previously studied or if it occurs in trials for conditions with physiologically-measured symptoms, such as hypertension. Method For this reason, we evaluated the efficacy data reported in the US Food and Drug Administration Medical and Statistical reviews for 23 antihypertensive programs (32,022 patients, 63 trials, 142 treatment arms). Placebo and medication response, effect sizes, and drug-placebo differences were calculated for each treatment arm and examined over time using meta-regression. We also explored the relationship of sample size, trial duration, baseline blood pressure, and number of treatment arms to placebo/drug response and efficacy outcome measures. Results Like trials of other conditions, placebo response has risen significantly over time (R2 = 0.093, p = 0.018) and effect size (R2 = 0.013, p = 0.187) drug-placebo difference (R2 = 0.013, p = 0.182) and success rate (134/142, 94.4%) have remained unaffected, likely due to a significant compensatory increase in antihypertensive response (R2 = 0.086, parms are likely overpowered with sample sizes increasing over time (R2 = 0.387, pblood pressure, and number of treatment arms yielded mixed results unlikely to explain the pattern of placebo response and efficacy outcomes over time. The magnitude of placebo response had no relationship to effect size (p = 0.877), antihypertensive-placebo differences (p = 0.752), or p-values (p = 0.963) but was correlated with antihypertensive response (R2 = 0.347, p<0.0001). Conclusions As hypothesized, this study shows that placebo response is increasing in clinical

  6. Neonatal outcomes in women with gestational diabetes mellitus treated with metformin in compare with insulin: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Safura Ruholamin

    2014-01-01

    Full Text Available Background: The objective of this study was to compare neonatal outcomes in women with gestational diabetes mellitus (GDM treated with either metformin or insulin. Materials and Methods: A randomized clinical trial carried out on year 2011 on 109 women with GDM who did not adequately control by dietary measures. They received metformin 500 mg once or twice daily or insulin 0.2 IU/kg/day initially. The dose was titrated to achieve target blood glucose values. Neonatal outcomes such as hypoglycemia, birth weight, Apgar score, umbilical artery pH, and hyperbilirubinemia in the 50 women who remained exclusively on metformin were compared with 50 women who treated with insulin. Results: Two groups were similar in mean fasting blood sugar (P = 0.7 and postprandial measurements (P = 0.8 throughout GDM treatment. Pregnancy complications or preterm labor were not different significantly between two groups. Considering neonatal outcomes between insulin and metformin groups, such as hypoglycemia (2 [4%] and 0 [0%], respectively, birth weight (3342 ± 506 mg and 3176 ± 438 mg, respectively, 5 th min Apgar score <7 (no one in either group, umbilical artery pH <7.05 (no one in either group and hyperbilirubinemia (1 [2%] and 0 [0%], respectively, no significant statistical differences were seen. Conclusion: Based on these preliminary data, considering neonatal outcomes, metformin appears to be a safe as insulin in the treatment of GDM.

  7. Enrollment in YFV Vaccine Trial: An Evaluation of Recruitment Outcomes Associated with a Randomized Controlled Double-Blind Trial of a Live Attenuated Yellow Fever Vaccine.

    Science.gov (United States)

    Frew, Paula M; Shapiro, Eve T; Lu, Lu; Edupuganti, Srilatha; Keyserling, Harry L; Mulligan, Mark J

    2013-04-15

    This investigation evaluated several factors associated with diverse participant enrollment of a clinical trial assessing safety, immunogenicity, and comparative viremia associated with administration of 17-D live, attenuated yellow fever vaccine given alone or in combination with human immune globulin. We obtained baseline participant information (e.g., sociodemographic, medical) and followed recruitment outcomes from 2005 to 2007. Of 355 potential Yellow Fever vaccine study participants, 231 cases were analyzed. Strong interest in study participation was observed among racial and ethnically diverse persons with 36.34% eligible following initial study screening, resulting in 18.75% enrollment. The percentage of white participants increased from 63.66% (prescreened sample) to 81.25% (enrollment group). The regression model was significant with white race as a predictor of enrollment (OR=2.744, 95% CI=1.415-5.320, p=0.003).In addition, persons were more likely to enroll via direct outreach and referral mechanisms compared to mass advertising (OR=2.433, 95% CI=1.102-5.369). The findings indicate that racially diverse populations can be recruited to vaccine clinical trials, yet actual enrollment may not reflect that diversity.

  8. Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators.

    Science.gov (United States)

    Craske, Michelle G; Niles, Andrea N; Burklund, Lisa J; Wolitzky-Taylor, Kate B; Vilardaga, Jennifer C Plumb; Arch, Joanna J; Saxbe, Darby E; Lieberman, Matthew D

    2014-12-01

    Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. The current study (N = 87) was a 3-arm randomized clinical trial comparing CBT, acceptance and commitment therapy (ACT), and a wait-list control group (WL) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and posttreatment, and participants assigned to CBT and ACT also completed assessments 6 and 12 months following baseline. Assessments consisted of self-report measures, a public-speaking task, and clinician ratings. Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public-speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Implications for clinical practice and future research are discussed.

  9. Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators

    Science.gov (United States)

    Craske, Michelle G; Niles, Andrea N.; Burklund, Lisa J.; Wolitzky-Taylor, Kate B.; Vilardaga, Jennifer C. Plumb; Arch, Joanna J.; Saxbe, Darby E.; Lieberman, Matthew D.

    2014-01-01

    Objective Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. Method The current study (N=87) was a 3-arm randomized clinical trial comparing CBT, Acceptance and Commitment therapy (ACT), and a waitlist control group (WL) in participants with a DSM-IV diagnosis of social phobia. Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and post-treatment, and participants assigned to CBT and ACT also completed assessments at 6 and 12 months following baseline. Assessments consisted of self-report measures, a public speaking task, and clinician ratings. Results Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-mo follow-up in CBT compared to ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control, and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Conclusions Implications for clinical practice and future research are discussed. PMID:24999670

  10. Scout-view assisted interior digital tomosynthesis (iDTS) based on compressed-sensing theory

    Science.gov (United States)

    Park, S. Y.; Kim, G. A.; Cho, H. S.; Seo, C. W.; Je, U. K.; Park, C. K.; Lim, H. W.; Kim, K. S.; Lee, D. Y.; Lee, H. W.; Kang, S. Y.; Park, J. E.; Woo, T. H.; Lee, M. S.

    2017-12-01

    Conventional digital tomosynthesis (DTS) based on the filtered-backprojection (FBP) reconstruction requires full field-of-view scan and also relatively dense projections, which results in still high dose for medical imaging purposes. In this work, to overcome these difficulties, we propose a new type of DTS examinations, the so-called scout-view assisted interior DTS (iDTS), in which the x-ray beam span covers only a small region-of-interest (ROI) containing target diagnosis with the help of some scout views and they are used in the reconstruction to add additional information to interior ROI otherwise absent with conventional iDTS reconstruction methods. We considered an effective iterative algorithm based on compressed-sensing theory, rather than the FBP-based algorithm, for more accurate iDTS reconstruction. We implemented the proposed algorithm, performed a systematic simulation and experiment, and investigated the image characteristics. We successfully reconstructed iDTS images of substantially high accuracy and no truncation artifacts by using the proposed method, preserving superior image homogeneity, edge sharpening, and in-plane spatial resolution.

  11. Circumferential scouting punch biopsies to delineate surgical margin for dermatofibrosarcoma protuberans

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    Tsung-Mao Huang

    2012-03-01

    Full Text Available Dermatofibrosarcoma protuberans (DFSP is an uncommon soft-tissue tumor involving the dermis and subcutaneous tissue with a high local recurrence rate after standard excision. Mohs micrographic surgery offers a lower recurrence rate. However, the procedure requires multiple stages of excision with intraoperative histopathological mapping, which is time consuming and expensive. We report our experience of using circumferential scouting punch biopsy technique in five patients to determine in advance the resection margins for DFSP prior to wide excision. Multiple 4 mm punches, usually eight in number, were performed 1–2.5 cm around the palpable borders of DFSP to delineate the resection margins in five consecutive patients. Tumors were excised at a later date along the margin defined by these biopsies and the wounds were repaired with skin graft. The operation was completed in 2 hours in all cases excluding one that required frozen sections for deep margin. No recurrence was noted 2–10 years after the operations. The results suggest that circumferential scouting punch biopsies before wide excision may be an alternative method to define the resection margins for DFSP when Mohs surgery is not available.

  12. Specifying the effects of physician's communication on patients' outcomes: A randomised controlled trial.

    Science.gov (United States)

    van Osch, Mara; van Dulmen, Sandra; van Vliet, Liesbeth; Bensing, Jozien

    2017-08-01

    To experimentally test the effects of physician's affect-oriented communication and inducing expectations on outcomes in patients with menstrual pain. Using a 2×2 RCT design, four videotaped simulated medical consultations were used, depicting a physician and a patient with menstrual pain. In the videos, two elements of physician's communication were manipulated: (1) affect-oriented communication (positive: warm, emphatic; versus negative: cold, formal), and (2) outcome expectation induction (positive versus uncertain). Participants (293 women with menstrual pain), acting as analogue patients, viewed one of the four videos. Pre- and post video participants' outcomes (anxiety, mood, self-efficacy, outcome expectations, and satisfaction) were assessed. Positive affect-oriented communication reduced anxiety (pcommunication. Positive expectations increased feelings of self-efficacy (pcommunication and a positive expectation reduced anxiety (p=0.02), increased outcome expectancies (p=0.01) and satisfaction (p=0.001). Being empathic and inducing positive expectations have distinct and combined effects, demonstrating that both are needed to influence patients' outcomes for the best. Continued medical training is needed to harness placebo-effects of medical communication into practice. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Local endometrial scratching under ultrasound-guidance after failed intrauterine insemination and cycle outcome: A randomized controlled trial

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    Badeea S. Soliman

    2017-03-01

    Full Text Available Background: Interaction between the embryo and endometrium plus endometrial receptivity is considered as two strong issues affecting the implantation outcome. Purpose: To investigate the effect of local endometrial scratching on pregnancy rate after failed previous intra uterine insemination. Study design: A prospective, randomized, control trial. Setting: At Cytogenetic and Endoscopy Unit, Zagazig University Hospital. Patients and methods: A total of 226 women either with unexplained or with mild male factor infertility were divided randomly into approximately two groups: in study group, 114 women and in control group, 112 women. For both groups, folliculometry was started at cycle day 7 additionally and at the same setting; endometrial scratching was done only for the study group. Outcome results: Biochemical and clinical pregnancy rates. Results: The biochemical and clinical pregnancy rates were significantly higher in the endometrial scratching group compared to the control group [27/106 (25.5% vs. 15/106 (14.1% p = 0.03 and 24/106 (22.6% vs. 12/106 (11.3%; p = 0.02] respectively. Also, ongoing pregnancy rate was statistically significantly different between both groups [22/106 (20.7% vs. 11/106 (10.4%; p = 0.03]. Conclusion: Endometrial scratching is useful in increasing pregnancy rates after failed previous intra uterine insemination trials when it is performed in the mid proliferative phase.

  14. Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes.

    Science.gov (United States)

    Orlandini, Andrés; Díaz, Rafael; Wojdyla, Daniel; Pieper, Karen; Van de Werf, Frans; Granger, Christopher B; Harrington, Robert A; Boersma, Eric; Califf, Robert M; Armstrong, Paul; White, Harvey; Simes, John; Paolasso, Ernesto

    2006-03-01

    To evaluate whether there is an association between 30-day mortality in patients with ST-segment elevation myocardial infarction (STEMI) included in clinical trials and country gross national income (GNI). A retrospective analysis of the databases of five randomized trials including 50 310 patients with STEMI (COBALT 7169, GIK-2 2931, HERO-2 17,089, ASSENT-2 17,005, and ASSENT-3 6116 patients) from 53 countries was performed. Countries were divided into three groups according to their GNI based on the World Bank data: low (less than 2900 US dollars), medium (between 2900 US dollars and 9000 US dollars), and high GNI (more than 9000 US dollars per capita). Baseline characteristics, in-hospital management variables, and 30-day outcomes were evaluated. A previously defined logistic regression model was used to adjust for differences in baseline characteristics and to predict mortality. The observed mortality was higher than the predicted mortality in the low (12.1 vs. 11.8%) and in the medium income groups (9.4 vs. 7.9%), whereas it was lower in the high income group (4.9 vs. 5.6%). An inverse relationship between mortality and GNI was observed in STEMI clinical trials. Most of the variability in mortality can be explained by differences in baseline characteristics; however, after adjustment, lower income countries have higher mortality than the expected.

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

    Directory of Open Access Journals (Sweden)

    Pilar Suñé

    Full Text Available OBJECTIVES: 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. METHODS AND FINDINGS: 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. CONCLUSIONS

  16. How did a Housing First intervention improve health and social outcomes among homeless adults with mental illness in Toronto? Two-year outcomes from a randomised trial.

    Science.gov (United States)

    O'Campo, Patricia; Stergiopoulos, Vicky; Nir, Pam; Levy, Matthew; Misir, Vachan; Chum, Antony; Arbach, Bouchra; Nisenbaum, Rosane; To, Matthew J; Hwang, Stephen W

    2016-09-12

    We studied the impact of a Housing First (HF) intervention on housing, contact with the justice system, healthcare usage and health outcomes among At Home/Chez Soi randomised trial participants in Toronto, a city with an extensive service network for social and health services for individuals who are experiencing homelessness and mental illness. Participants identified as high needs were randomised to receive either the intervention which provided them with housing and supports by an assertive community treatment team (HF+ACT) or treatment as usual (TAU). Participants (N=197) had in-person interviews every 3 months for 2 years. The HF+ACT group spent more time stably housed compared to the TAU group with the mean difference between the groups of 45.8% (95% CI 37.1% to 54.4%, phousing stability and selected health and justice outcomes over 2 years in a city with many social and health services. ISRCTN42520374. 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/

  17. Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China.

    Science.gov (United States)

    Zhang, Yuting; Tang, Wenxi; Zhang, Yan; Liu, Lulu; Zhang, Liang

    2017-03-11

    Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. A clustered randomized controlled trial was conducted in six towns in China's Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization's International Clinical Trials Registry, number ChiCTR-OOR-14005563. We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063-3.8), improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094-0.24). We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73-2.79) and reduced rates of hospitalization and inpatient spending, but it also reduced patients' self-assessed health-related quality of life. Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at the Chinese Clinical Trial Registry (ChiCTR-OOR-14005563) on November 23, 2014

  18. Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China

    Directory of Open Access Journals (Sweden)

    Yuting Zhang

    2017-03-01

    Full Text Available Abstract Background Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. Methods A clustered randomized controlled trial was conducted in six towns in China’s Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization’s International Clinical Trials Registry, number ChiCTR-OOR-14005563. Results We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063–3.8, improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094–0.24. We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73–2.79 and reduced rates of hospitalization and inpatient spending, but it also reduced patients’ self-assessed health-related quality of life. Conclusions Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at

  19. Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce confounding in mediation investigations.

    Science.gov (United States)

    Landau, Sabine; Emsley, Richard; Dunn, Graham

    2018-06-01

    Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise. Investigators increasingly carry out explanatory analyses to decompose total treatment effects into components that are mediated by an intermediate continuous outcome and a non-mediated part. Traditional mediation analysis might be performed based on (A) post-treatment values of the intermediate and clinical outcomes alone, (B) respective change scores or (C) conditioning on baseline measures of both intermediate and clinical outcomes. Using causal diagrams and Monte Carlo simulation, we investigated the performance of the three competing mediation approaches. We considered a data generating model that included three possible confounding processes involving baseline variables: The first two processes modelled baseline measures of the clinical variable or the intermediate variable as common causes of post-treatment measures of these two variables. The third process allowed the two baseline variables themselves to be correlated due to past common causes. We compared the analysis models implied by the competing mediation approaches with this data generating model to hypothesise likely biases in estimators, and tested these in a simulation study. We applied the methods to a randomised trial of pragmatic rehabilitation in patients with chronic fatigue syndrome, which examined the role of limiting activities as a mediator. Estimates of causal mediation effects derived by approach (A) will be biased if one of

  20. Crestal Sinus Augmentation with Recombinant Human Bone Morphogenetic Protein 2: Clinical and Radiographic Outcomes of 2-Year Pilot Trial.

    Science.gov (United States)

    Kuchler, Ulrike; Rudelstorfer, Claudia M; Barth, Barbara; Tepper, Gabor; Lidinsky, Dominika; Heimel, Patrick; Watzek, Georg; Gruber, Reinhard

    Recombinant human bone morphogenetic protein 2 (rhBMP-2) together with an absorbable collagen carrier (ACS) was approved for augmentation of the maxillary sinus prior to implant placement. The original registration trial was based on a lateral window approach. Clinical outcomes of crestal sinus augmentation with rhBMP-2 have not been reported so far. An uncontrolled pilot trial in which seven patients with a residual maxillary height below 5 mm were enrolled to receive crestal sinus augmentation with rhBMP-2/ACS was conducted. Elevation of the sinus mucosa was performed by gel pressure. Primary endpoints were the gain in augmentation height and volume measured by computed tomography after 6 months. Evaluation of bone quality at the time of implant placement was based on histology. Secondary endpoints were the clinical and radiologic evaluation of the implants and patient satisfaction by visual analog scale (VAS) at the 2-year follow-up. Median gain in augmentation height was 7.2 mm (range 0.0 to 17.5 mm). Five patients gained at least 5 mm of bone height. Two patients with a perforation of the sinus mucosa failed to respond to rhBMP-2/ACS and underwent lateral window augmentation. The median gain in augmentation volume of the five patients was 781.3 mm³ (range 426.9 to 1,242.8 mm³). Biopsy specimens showed a cancellous network consisting of primary plexiform bone with little secondary lamellar bone. After 2 years, implants were in function with no signs of inflammation or peri-implant bone loss. Patients were satisfied with the esthetic outcomes and chewing function. This pilot clinical trial supports the original concept that rhBMP-2/ACS supports bone formation, also in crestal sinus augmentation, and emphasizes the relevance of the integrity of the sinus mucosa to predict the bone gain.

  1. Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol.

    Science.gov (United States)

    Chibwesha, Carla J; Ford, Catherine E; Mollan, Katie R; Stringer, Jeffrey S A

    2016-08-01

    In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resource settings, centralized systems often lead to result turnaround times of several months, long delays in diagnosis, and adverse outcomes for HIV-infected children. Our clinical trial tests the effectiveness of a new point-of-care (POC) diagnostic technology to identify HIV-infected infants and start providing them life-saving ART as soon as possible. The study uses a randomized, controlled design to test whether the Alere q platform for HIV DNA polymerase chain reaction (PCR) testing improves outcomes of HIV-infected children in Zambia. We aim to enroll 2867 HIV-exposed infants aged 4-12 weeks and to follow those who are HIV infected for 12 months as they receive HIV care at 6 public health facilities in Lusaka. The trial's primary endpoint is the proportion of HIV-infected infants in each study arm who start ART and remain alive, in care, and virally suppressed 12 months after their diagnostic blood draw. Our trial will provide evidence for the incremental benefit of implementing a POC EID strategy in low-resource settings where only off-site PCR services are currently available. The results will be useful in guiding future decisions regarding investments in POC virologic testing as part of overall pediatric AIDS mitigation strategies in sub-Saharan Africa. clinicaltrials.gov NCT02682810.

  2. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

    Science.gov (United States)

    Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

    2010-10-01

    In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

  3. Stakeholder Engagement in Trial Design: Survey of Visitors to Critically Ill Patients Regarding Preferences for Outcomes and Treatment Options during Weaning from Mechanical Ventilation.

    Science.gov (United States)

    Burns, Karen E A; Jacob, Sonu Karottaiyamvelil; Aguirre, Valeria; Gomes, Janice; Mehta, Sangeeta; Rizvi, Leena

    2016-11-01

    Stakeholder engagement in research is expected to provide unique insights, make research investments more accountable and transparent, and ensure that future research is applicable to patients and family members. To inform the design of a trial of strategies for weaning from mechanical ventilation, we sought to identify preferences of patient visitors regarding outcome and treatment measures. We conducted an interviewer-administered questionnaire of visitors of critically ill patients in two family waiting rooms serving three intensive care units (ICUs) in Toronto, Canada. Respondents rated the importance of general and ventilation-related outcomes in two hypothetical scenarios (before a first spontaneous breathing trial, and after a failed spontaneous breathing trial) and selected a preferred technique for the breathing trials. With regard to the patient they were visiting, respondents identified the most important outcome to them at ICU admission, during the ICU stay, and at ICU discharge. We analyzed 322 questionnaires (95.5% response rate). All outcomes were highly rated (average range: 7.82-9.74). Across scenarios, outcomes rated as most important were ICU and hospital survival (9.72, 9.70), avoiding complications (9.45), quality of life (9.394), patient comfort (9.393), and returning to previous living arrangements (9.31). Overall, the most important ventilation-related outcomes were being ventilator-free (8.95), avoiding reintubation (8.905), and passing a spontaneous breathing trial (8.903). Passing a spontaneous breathing trial assumed greater importance after an initial failed attempt. "Time to event" outcomes were less important to visitors. We did not identify a preferred spontaneous breathing trial technique. Although ICU survival was the most important outcome at ICU admission and during the ICU stay, visitors rated quality of life higher than hospital survival at ICU discharge. Visitors to critically ill patients prioritized two general outcomes (ICU

  4. Background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-Saharan Africa.

    Directory of Open Access Journals (Sweden)

    Lauren A V Orenstein

    Full Text Available Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa.We developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM, low birth weight (LBW, prematurity, and major congenital malformations (MCM in Sub-Saharan African countries were also performed.Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6-73.3 per 1,000 total births, and the most common causes were hemorrhage (34%, dystocia (22%, and severe hypertensive disorders of pregnancy (22%. Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9-16.4 or premature (median 15.4%, IQR: 10.6-19.1 were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5-17.6, with the musculoskeletal system comprising 30%.Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies that quantify population-based background rates of

  5. Effects of supplemental vibrational force on space closure, treatment duration, and occlusal outcome: A multicenter randomized clinical trial.

    Science.gov (United States)

    DiBiase, Andrew T; Woodhouse, Neil R; Papageorgiou, Spyridon N; Johnson, Nicola; Slipper, Carmel; Grant, James; Alsaleh, Maryam; Khaja, Yousef; Cobourne, Martyn T

    2018-04-01

    A multicenter parallel 3-arm randomized clinical trial was carried out in 3 university hospitals in the United Kingdom to investigate the effect of supplemental vibratory force on space closure and treatment outcome with fixed appliances. Eighty-one subjects less than 20 years of age with mandibular incisor irregularity undergoing extraction-based fixed appliance treatment were randomly allocated to supplementary (20 minutes/day) use of an intraoral vibrational device (AcceleDent; OrthoAccel Technologies, Houston, Tex) (n = 29), an identical nonfunctional (sham) device (n = 25), or fixed-appliance only (n = 27). Space closure in the mandibular arch was measured from dental study casts taken at the start of space closure, at the next appointment, and at completion of space closure. Final records were taken at completion of treatment. Data were analyzed blindly on a per-protocol basis with descriptive statistics, 1-way analysis of variance, and linear regression modeling with 95% confidence intervals. Sixty-one subjects remained in the trial at start of space closure, with all 3 groups comparable for baseline characteristics. The overall median rate of initial mandibular arch space closure (primary outcome) was 0.89 mm per month with no difference for either the AcceleDent group (difference, -0.09 mm/month; 95% CI, -0.39 to 0.22 mm/month; P = 0.57) or the sham group (difference, -0.02 mm/month; 95% CI, -0.32 to 0.29 mm/month; P = 0.91) compared with the fixed only group. Similarly, no significant differences were identified between groups for secondary outcomes, including overall treatment duration (median, 18.6 months; P >0.05), number of visits (median, 12; P >0.05), and percentage of improvement in the Peer Assessment Rating (median, 90.0%; P >0.05). Supplemental vibratory force during orthodontic treatment with fixed appliances does not affect space closure, treatment duration, total number of visits, or final occlusal outcome. NCT02314975

  6. Analysis of time to event outcomes in randomized controlled trials by generalized additive models.

    Directory of Open Access Journals (Sweden)

    Christos Argyropoulos

    Full Text Available Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking.By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population.PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data.By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial results under proportional and

  7. Predicting treatment effect from surrogate endpoints and historical trials: an extrapolation involving probabilities of a binary outcome or survival to a specific time.

    Science.gov (United States)

    Baker, Stuart G; Sargent, Daniel J; Buyse, Marc; Burzykowski, Tomasz

    2012-03-01

    Using multiple historical trials with surrogate and true endpoints, we consider various models to predict the effect of treatment on a true endpoint in a target trial in which only a surrogate endpoint is observed. This predicted result is computed using (1) a prediction model (mixture, linear, or principal stratification) estimated from historical trials and the surrogate endpoint of the target trial and (2) a random extrapolation error estimated from successively leaving out each trial among the historical trials. The method applies to either binary outcomes or survival to a particular time that is computed from censored survival data. We compute a 95% confidence interval for the predicted result and validate its coverage using simulation. To summarize the additional uncertainty from using a predicted instead of true result for the estimated treatment effect, we compute its multiplier of standard error. Software is available for download. © 2011, The International Biometric Society No claim to original US government works.

  8. Periodontal treatment during pregnancy decreases the rate of adverse pregnancy outcome: a controlled clinical trial.

    Science.gov (United States)

    Sant'Ana, Adriana Campos Passanezi; Campos, Marinele R de; Passanezi, Selma Campos; Rezende, Maria Lúcia Rubo de; Greghi, Sebastião Luiz Aguiar; Passanezi, Euloir

    2011-04-01

    The aim of this study was to evaluate the effects of non-surgical treatment of periodontal disease during the second trimester of gestation on adverse pregnancy outcomes. Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center were divided into 2 groups: NIG--"no intervention" (n=17) or IG--"intervention" (n=16). IG patients were submitted to a non-surgical periodontal treatment performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). NIG received PROPH and OHI during pregnancy and were referred for treatment after delivery. Periodontal evaluation was performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes were preterm birth (Periodontal treatment resulted in stabilization of CAL and PI (p>0.05) at IG and worsening of all periodontal parameters at NIG (pperiodontal conditions of IG and NIG were observed at 2nd examination (ppregnancy outcomes was 47.05% in NIG and 6.25% in IG. Periodontal treatment during pregnancy was associated to a decreased risk of developing adverse pregnancy outcomes [OR=13.50; CI: 1.47-123.45; p=0.02]. Periodontal treatment during the second trimester of gestation contributes to decrease adverse pregnancy outcomes.

  9. Does the increasing placebo response impact outcomes of adult and pediatric ADHD clinical trials? Data from the US Food and Drug Administration 2000-2009.

    Science.gov (United States)

    Khan, Arif; Fahl Mar, Kaysee; Brown, Walter A

    2017-11-01

    In a study of recent antidepressant clinical trial data, it was found placebo response had grown significantly over time and that contrary to expectations, trial outcome measures and success rate were not impacted. The aim of this paper was to evaluate if this trend of increasing placebo response and stable outcome measures could be seen in clinical trial data for Attention-Deficit Hyperactivity Disorder, a different psychiatric condition with susceptibility to placebo response. For this reason, we evaluated efficacy data reported in the FDA Medical and Statistical reviews for 10 ADHD medication programs (4917 patients, 17 trials, 29 treatment arms). Placebo and medication response were measured as percent symptom reduction and effect sizes and drug-placebo differences were calculated for each treatment arm and analyzed in relation to year of approval. We also investigated the potential role of age and medication class on trends and outcomes. Results showed a similar pattern to antidepressants wherein the placebo response is rising significantly over time (r = 0.636, p = 0.006) and effect size (r stimulants were found to have more robust treatment effects than adult trials and non-stimulants. The results of this study suggest that like antidepressants, the relationship between placebo response and the outcomes of ADHD clinical trials is weak at best. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Midtrimester preterm prelabour rupture of membranes (PPROM): expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL - III trial).

    Science.gov (United States)

    van Teeffelen, Augustinus S P; van der Ham, David P; Willekes, Christine; Al Nasiry, Salwan; Nijhuis, Jan G; van Kuijk, Sander; Schuyt, Ewoud; Mulder, Twan L M; Franssen, Maureen T M; Oepkes, Dick; Jansen, Fenna A R; Woiski, Mallory D; Bekker, Mireille N; Bax, Caroline J; Porath, Martina M; de Laat, Monique W M; Mol, Ben W; Pajkrt, Eva

    2014-04-04

    Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05). This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. NTR3492 Dutch Trial Register (http://www.trialregister.nl).

  11. Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial

    Science.gov (United States)

    Braithwaite, Bruce; Cheshire, Nicholas J.; Greenhalgh, Roger M.; Grieve, Richard; Hassan, Tajek B.; Hinchliffe, Robert; Howell, Simon; Moore, Fionna; Nicholson, Anthony A.; Soong, Chee V.; Thompson, Matt M.; Thompson, Simon G.; Ulug, Pinar; Heatley, Francine; Anjum, Aisha; Kalinowska, Gosia; Sweeting, Michael J.; Thompson, Simon G.; Gomes, Manuel; Grieve, Richard; Powell, Janet T.; Ashleigh, Ray; Gomes, Manuel; Greenhalgh, Roger M.; Grieve, Richard; Hinchliffe, Robert; Sweeting, Michael; Thompson, Matt M.; Thompson, Simon G.; Ulug, Pinar; Roberts, Ian; Bell, Peter R. F.; Cheetham, Anne; Stephany, Jenny; Warlow, Charles; Lamont, Peter; Moss, Jonathan; Tijssen, Jan; Braithwaite, Bruce; Nicholson, Anthony A.; Thompson, Matthew; Ashleigh, Ray; Thompson, Luke; Cheshire, Nicholas J.; Boyle, Jonathan R.; Serracino-Inglott, Ferdinand; Thompson, Matt M.; Hinchliffe, Robert J.; Bell, Rachel; Wilson, Noel; Bown, Matt; Dennis, Martin; Davis, Meryl; Ashleigh, Ray; Howell, Simon; Wyatt, Michael G.; Valenti, Domenico; Bachoo, Paul; Walker, Paul; MacSweeney, Shane; Davies, Jonathan N.; Rittoo, Dynesh; Parvin, Simon D.; Yusuf, Waquar; Nice, Colin; Chetter, Ian; Howard, Adam; Chong, Patrick; Bhat, Raj; McLain, David; Gordon, Andrew; Lane, Ian; Hobbs, Simon; Pillay, Woolagasen; Rowlands, Timothy; El-Tahir, Amin; Asquith, John; Cavanagh, Steve; Dubois, Luc; Forbes, Thomas L.; Ashworth, Emily; Baker, Sara; Barakat, Hashem; Brady, Claire; Brown, Joanne; Bufton, Christine; Chance, Tina; Chrisopoulou, Angela; Cockell, Marie; Croucher, Andrea; Dabee, Leela; Dewhirst, Nikki; Evans, Jo; Gibson, Andy; Gorst, Siobhan; Gough, Moira; Graves, Lynne; Griffin, Michelle; Hatfield, Josie; Hogg, Florence; Howard, Susannah; Hughes, Cían; Metcalfe, David; Lapworth, Michelle; Massey, Ian; Novick, Teresa; Owen, Gareth; Parr, Noala; Pintar, David; Spencer, Sarah; Thomson, Claire; Thunder, Orla; Wallace, Tom; Ward, Sue; Wealleans, Vera; Wilson, Lesley; Woods, Janet; Zheng, Ting

    2015-01-01

    Aims To report the longer term outcomes following either a strategy of endovascular repair first or open repair of ruptured abdominal aortic aneurysm, which are necessary for both patient and clinical decision-making. Methods and results This pragmatic multicentre (29 UK and 1 Canada) trial randomized 613 patients with a clinical diagnosis of ruptured aneurysm; 316 to an endovascular first strategy (if aortic morphology is suitable, open repair if not) and 297 to open repair. The principal 1-year outcome was mortality; secondary outcomes were re-interventions, hospital discharge, health-related quality-of-life (QoL) (EQ-5D), costs, Quality-Adjusted-Life-Years (QALYs), and cost-effectiveness [incremental net benefit (INB)]. At 1 year, all-cause mortality was 41.1% for the endovascular strategy group and 45.1% for the open repair group, odds ratio 0.85 [95% confidence interval (CI) 0.62, 1.17], P = 0.325, with similar re-intervention rates in each group. The endovascular strategy group and open repair groups had average total hospital stays of 17 and 26 days, respectively, P < 0.001. Patients surviving rupture had higher average EQ-5D utility scores in the endovascular strategy vs. open repair groups, mean differences 0.087 (95% CI 0.017, 0.158), 0.068 (95% CI −0.004, 0.140) at 3 and 12 months, respectively. There were indications that QALYs were higher and costs lower for the endovascular first strategy, combining to give an INB of £3877 (95% CI £253, £7408) or €4356 (95% CI €284, €8323). Conclusion An endovascular first strategy for management of ruptured aneurysms does not offer a survival benefit over 1 year but offers patients faster discharge with better QoL and is cost-effective. Clinical trial registration ISRCTN 48334791. PMID:25855369

  12. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma.

    Science.gov (United States)

    Facon, Thierry; Dimopoulos, Meletios A; Dispenzieri, Angela; Catalano, John V; Belch, Andrew; Cavo, Michele; Pinto, Antonello; Weisel, Katja; Ludwig, Heinz; Bahlis, Nizar J; Banos, Anne; Tiab, Mourad; Delforge, Michel; Cavenagh, Jamie D; Geraldes, Catarina; Lee, Je-Jung; Chen, Christine; Oriol, Albert; De La Rubia, Javier; White, Darrell; Binder, Daniel; Lu, Jin; Anderson, Kenneth C; Moreau, Philippe; Attal, Michel; Perrot, Aurore; Arnulf, Bertrand; Qiu, Lugui; Roussel, Murielle; Boyle, Eileen; Manier, Salomon; Mohty, Mohamad; Avet-Loiseau, Herve; Leleu, Xavier; Ervin-Haynes, Annette; Chen, Guang; Houck, Vanessa; Benboubker, Lotfi; Hulin, Cyrille

    2018-01-18

    This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥60 months' follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.67-0.92; P = .0023), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had an ≈30-month longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. This trial was registered at www.clinicaltrials.gov as #NCT00689936 and EudraCT as 2007-004823-39. © 2018 by The American Society of Hematology.

  13. Cigarette Smoking During Substance Use Disorder Treatment: Secondary Outcomes from a National Drug Abuse Treatment Clinical Trials Network study.

    Science.gov (United States)

    McClure, Erin A; Campbell, Aimee N C; Pavlicova, Martina; Hu, Meichen; Winhusen, Theresa; Vandrey, Ryan G; Ruglass, Lesia M; Covey, Lirio S; Stitzer, Maxine L; Kyle, Tiffany L; Nunes, Edward V

    2015-06-01

    The majority of patients enrolled in treatment for substance use disorders (SUDs) also use tobacco. Many will continue to use tobacco even during abstinence from other drugs and alcohol, often leading to smoking-related illnesses. Despite this, little research has been conducted to assess the influence of being a smoker on SUD treatment outcomes and changes in smoking during a treatment episode. In this secondary analysis, cigarette smoking was evaluated in participants completing outpatient SUD treatment as part of a multi-site study conducted by the National Drug Abuse Treatment Clinical Trials Network. Analyses included the assessment of changes in smoking and nicotine dependence via the Fagerström Test for Nicotine Dependence during the 12-week study among all smokers (aim #1), specifically among those in the experimental treatment group (aim #2), and the moderating effect of being a smoker on treatment outcomes (aim #3). Participants generally did not reduce or quit smoking throughout the course of the study. Among a sub-set of participants with higher baseline nicotine dependence scores randomized to the control arm, scores at the end of treatment were lower compared to the experimental arm, though measures of smoking quantity did not appear to decrease. Further, being a smoker was associated with poorer treatment outcomes compared to non-smokers enrolled in the trial. This study provides evidence that patients enrolled in community-based SUD treatment continue to smoke, even when abstaining from drugs and alcohol. These results add to the growing literature encouraging the implementation of targeted, evidence-based interventions to promote abstinence from tobacco among SUD treatment patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. The Lunar Scout Program: An international program to survey the Moon from orbit for geochemistry, mineralogy, imagery, geodesy, and gravity

    Science.gov (United States)

    Morrison, Donald A. (Editor)

    1994-01-01

    The Lunar Scout Program was one of a series of attempts by NASA to develop and fly an orbiting mission to the moon to collect geochemical, geological, and gravity data. Predecessors included the Lunar Observer, the Lunar Geochemical Orbiter, and the Lunar Polar Orbiter - missions studied under the auspices of the Office of Space Science. The Lunar Scout Program, however, was an initiative of the Office of Exploration. It was begun in late 1991 and was transferred to the Office of Space Science after the Office of Exploration was disbanded in 1993. Most of the work was done by a small group of civil servants at the Johnson Space Center; other groups also responsible for mission planning included personnel from the Charles Stark Draper Laboratories, the Lawrence Livermore National Laboratory, Boeing, and Martin Marietta. The Lunar Scout Program failed to achieve new start funding in FY 93 and FY 94 as a result of budget downturns, the de-emphasis of the Space Exploration Initiative, and the fact that lunar science did not rate as high a priority as other planned planetary missions, and was cancelled. The work done on the Lunar Scout Program and other lunar orbiter studies, however, represents assets that will be useful in developing new approaches to lunar orbit science.

  15. Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period

    DEFF Research Database (Denmark)

    Caterson, Ian; Coutinho, Walmir; Finer, Nick

    2010-01-01

    pulse rate increases; median 1.5 bpm (nonconformers) vs. 3.0 bpm (conformers). There was a low incidence of serious adverse events (conformers: 1.0%; nonconformers: 2.8%) and ~93% of patients in both groups completed the 6-week period. The SCOUT lead-in period evaluating weight management...

  16. Exploration and exploitation of food sources by social insect colonies: a revision of the scout-recruit concept

    NARCIS (Netherlands)

    Biesmeijer, J.C.; Vries, Han de

    2000-01-01

    Social insect colonies need to explore and exploit multiple food sources simultaneously and efficiently. At the individual level, this colony-level behaviour has been thought to be taken care of by two types of individual: scouts that independently search for food, and recruits that are

  17. Global Scouts

    National Research Council Canada - National Science Library

    Wagner, Robert W; Hall, Michael T

    2006-01-01

    One result of the Battle of Mogadishu, 3-4 October 1993, in which 18 American soldiers died and 73 were wounded, was the development and implementation of Tactical Combat Casualty Care (TCCC) Guidelines...

  18. PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    de Jonge Peter

    2011-06-01

    Full Text Available Abstract Background There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. However, to date no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy actually could prevent psychosocial problems in children. Preventing psychosocial problems in children will eventually bring down the huge public health burden of mental disease. The main objective of this study is to assess the effects of cognitive behavioural therapy in pregnant women with symptoms of anxiety or depression on the child's development as well as behavioural and emotional problems. In addition, we aim to study its effects on the child's development, maternal mental health, and neonatal outcomes, as well as the cost-effectiveness of cognitive behavioural therapy relative to usual care. Methods/design We will include 300 women with at least moderate levels of anxiety or depression at the end of the first trimester of pregnancy. By including 300 women we will be able to demonstrate effect sizes of 0.35 or over on the total problems scale of the child behavioural checklist 1.5-5 with alpha 5% and power (1-beta 80%. Women in the intervention arm are offered 10-14 individual cognitive behavioural therapy sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week. Women in the control group receive care as usual. Primary outcome is behavioural/emotional problems at 1.5 years of age as assessed by the total problems scale of the child behaviour checklist 1.5 - 5 years. Secondary outcomes will be mental, psychomotor and behavioural development of the child at age 18 months according to the Bayley scales, maternal anxiety and depression during pregnancy and postpartum, and neonatal outcomes such as birth weight, gestational age and Apgar score, health care consumption and general health status

  19. A hierarchy of patient-reported outcomes for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten; Lund, Hans; Roos, Ewa M

    2012-01-01

    Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs) measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA). Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology...

  20. ST-elevation acute coronary syndromes in the Platelet Inhibition and Patient Outcomes (PLATO) trial

    DEFF Research Database (Denmark)

    Armstrong, Paul W; Siha, Hany; Fu, Yuling

    2012-01-01

    Ticagrelor, when compared with clopidogrel, reduced the 12-month risk of vascular death/myocardial infarction and stroke in patients with ST-elevation acute coronary syndromes intended to undergo primary percutaneous coronary intervention in the PLATelet inhibition and patient Outcomes (PLATO...

  1. Predicting Outcome in Computerized Cognitive Behavioral Therapy for Depression in Primary Care: A Randomized Trial

    Science.gov (United States)

    de Graaf, L. Esther; Hollon, Steven D.; Huibers, Marcus J. H.

    2010-01-01

    Objective: To explore pretreatment and short-term improvement variables as potential moderators and predictors of 12-month follow-up outcome of unsupported online computerized cognitive behavioral therapy (CCBT), usual care, and CCBT combined with usual care for depression. Method: Three hundred and three depressed patients were randomly allocated…

  2. Melatonin for Sleep in Children with Autism: A Controlled Trial Examining Dose, Tolerability, and Outcomes

    Science.gov (United States)

    Malow, Beth; Adkins, Karen W.; McGrew, Susan G.; Wang, Lily; Goldman, Suzanne E.; Fawkes, Diane; Burnette, Courtney

    2012-01-01

    Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label dose-escalation study to assess dose-response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures…

  3. Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials

    DEFF Research Database (Denmark)

    Petkovic, Jennifer; Barton, Jennifer L; Flurey, Caroline

    2017-01-01

    , and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking...

  4. One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial

    Science.gov (United States)

    Rastan, Aljoscha; McKinsey, James F.; Garcia, Lawrence A.; Rocha-Singh, Krishna J.; Jaff, Michael R.; Harlin, Stuart; Kamat, Suraj; Janzer, Sean; Zeller, Thomas

    2017-01-01

    Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound–defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients. PMID:29117818

  5. Joint modelling of longitudinal outcome and interval-censored competing risk dropout in a schizophrenia clinical trial

    Science.gov (United States)

    Gueorguieva, Ralitza; Rosenheck, Robert; Lin, Haiqun

    2011-01-01

    Summary The ‘Clinical antipsychotic trials in intervention effectiveness’ study, was designed to evaluate whether there were significant differences between several antipsychotic medications in effectiveness, tolerability, cost and quality of life of subjects with schizophrenia. Overall, 74 % of patients discontinued the study medication for various reasons before the end of 18 months in phase I of the study. When such a large percentage of study participants fail to complete the study schedule, it is not clear whether the apparent profile in effectiveness reflects genuine changes over time or is influenced by selection bias, with participants with worse (or better) outcome values being more likely to drop out or to discontinue. To assess the effect of dropouts for different reasons on inferences, we construct a joint model for the longitudinal outcome and cause-specific dropouts that allows for interval-censored dropout times. Incorporating the information regarding the cause of dropout improves inferences and provides better understanding of the association between cause-specific dropout and the outcome process. We use simulations to demonstrate the advantages of the joint modelling approach in terms of bias and efficiency. PMID:22468033

  6. Effect of self-hypnosis on duration of labor and maternal and neonatal outcomes: a randomized controlled trial.

    Science.gov (United States)

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Nohr, Ellen A

    2013-07-01

    To examine the effect of a brief course in self-hypnosis for childbirth on duration of the labor and other birth outcomes. A randomized, controlled, single-blind trial. Aarhus University Hospital Skejby, Denmark. A total of 1222 healthy nulliparous women. A hypnosis group receiving three 1-h lessons in self-hypnosis with additional audio-recordings to ease childbirth, a relaxation group receiving three 1-h lessons in various relaxation methods and mindfulness with audio-recordings for additional training, and a usual-care group receiving only the usual antenatal care were compared. Duration of labor, birth complications, lactation success, caring for the child, and preferred future mode of delivery. No differences were found across the three groups on duration from arriving at the birth department until the expulsive phase of second stage of labor, the duration of the expulsive phase, or other birth outcomes. Fewer emergency and more elective cesarean sections occurred in the hypnosis group. No difference was seen across the groups for lactation success or caring for the child but fewer women in the hypnosis group preferred a cesarean section in future pregnancies because of fear of childbirth and negative birth experiences. Learning self-hypnosis to ease childbirth taught as a brief course failed to show any effects on duration of childbirth and other birth outcomes. © 2013 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

  7. Home-based walking during pregnancy affects mood and birth outcomes among sedentary women: A randomized controlled trial.

    Science.gov (United States)

    Taniguchi, Chie; Sato, Chifumi

    2016-10-01

    We examined the effects of home-based walking on sedentary Japanese women's pregnancy outcomes and mood. A randomized controlled trial was conducted, involving 118 women aged 22-36 years. Participants were randomly assigned to walking intervention (n = 60) or control (n = 58) groups. The walking group was instructed to walk briskly for 30 min, three times weekly from 30 weeks' gestation until delivery. Both groups counted their daily steps using pedometers. Pregnancy and delivery outcomes were assessed, participants completed the Profile of Mood States, and we used the intention-to-treat principle. Groups showed no differences regarding pregnancy or delivery outcomes. The walking group exhibited decreased scores on the depression-dejection and confusion subscales of the Profile of Mood States. Five of the 54 women in the intervention group who remained in the study (9.2%) completed 100% of the prescribed walking program; 32 (59.3%) women completed 80% or more. Unsupervised walking improves sedentary pregnant women's mood, indicating that regular walking during pregnancy should be promoted in this group. © 2016 John Wiley & Sons Australia, Ltd.

  8. Periodontal treatment during pregnancy decreases the rate of adverse pregnancy outcome: a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Adriana Campos Passanezi Sant'Ana

    2011-04-01

    Full Text Available OBJECTIVES: The aim of this study was to evaluate the effects of non-surgical treatment of periodontal disease during the second trimester of gestation on adverse pregnancy outcomes. MATERIAL AND METHODS: Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center were divided into 2 groups: NIG - "no intervention" (n=17 or IG- "intervention" (n=16. IG patients were submitted to a non-surgical periodontal treatment performed by a single periodontist consisting of scaling and root planning (SRP, professional prophylaxis (PROPH and oral hygiene instruction (OHI. NIG received PROPH and OHI during pregnancy and were referred for treatment after delivery. Periodontal evaluation was performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD, clinical attachment level (CAL, plaque index (PI and sulcular bleeding index (SBI at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes were preterm birth (0.05 at IG and worsening of all periodontal parameters at NIG (p<0.0001, except for PI. Signifcant differences in periodontal conditions of IG and NIG were observed at 2nd examination (p<0.001. The rate of adverse pregnancy outcomes was 47.05% in NIG and 6.25% in IG. Periodontal treatment during pregnancy was associated to a decreased risk of developing adverse pregnancy outcomes [OR=13.50; CI: 1.47-123.45; p=0.02]. CONCLUSIONS: Periodontal treatment during the second trimester of gestation contributes to decrease adverse pregnancy outcomes.

  9. CT dose modulation using automatic exposure control in whole-body PET/CT: effects of scout imaging direction and arm positioning.

    Science.gov (United States)

    Inoue, Yusuke; Nagahara, Kazunori; Kudo, Hiroko; Itoh, Hiroyasu

    2018-01-01

    Automatic exposure control (AEC) modulates tube current and consequently X-ray exposure in CT. We investigated the behavior of AEC systems in whole-body PET/CT. CT images of a whole-body phantom were acquired using AEC on two scanners from different manufactures. The effects of scout imaging direction and arm positioning on dose modulation were evaluated. Image noise was assessed in the chest and upper abdomen. On one scanner, AEC using two scout images in the posteroanterior (PA) and lateral (Lat) directions provided relatively constant image noise along the z-axis with the arms at the sides. Raising the arms increased tube current in the head and neck and decreased it in the body trunk. Image noise increased in the upper abdomen, suggesting excessive reduction in radiation exposure. AEC using the PA scout alone strikingly increased tube current and reduced image noise in the shoulder. Raising the arms did not substantially influence dose modulation and decreased noise in the abdomen. On the other scanner, AEC using the PA scout alone or Lat scout alone resulted in similar dose modulation. Raising the arms increased tube current in the head and neck and decreased it in the trunk. Image noise was higher in the upper abdomen than in the middle and lower chest, and was not influenced by arm positioning. CT dose modulation using AEC may vary greatly depending on scout direction. Raising the arms tended to decrease radiation exposure; however, the effect depends on scout direction and the AEC system.

  10. Serum Potassium Levels and Outcome in Acute Heart Failure (Data from the PROTECT and COACH Trials)

    OpenAIRE

    Tromp, Jasper; ter Maaten, Jozine M.; Damman, Kevin; OConnor, Christopher M.; Metra, Marco; Dittrich, Howard C.; Ponikowski, Piot; Teerlink, John R.; Cotter, Gad; Davison, Beth; Cleland, John G. F.; Givertz, Michael M.; Bloomfield, Daniel M.; van der Wal, Martje H. L.; Jaarsma, Tiny

    2017-01-01

    Serum potassium is routinely measured at admission for acute heart failure (AHF), but information on association with clinical variables and prognosis is limited. Potassium measurements at admission were available in 1,867 patients with AHF in the original cohort of 2,033 patients included in the Patients Hospitalized with acute heart failure and Volume Overload to Assess Treatment Effect on Congestion and Renal FuncTion trial. Patients were grouped according to low potassium (amp;lt;3.5 mEq/...

  11. Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Zhang S

    2014-07-01

    .38 and percent change (–0.019; 95% CI: -0.087, 0.050; P=0.58.Conclusion: ANCOVA, through both simulation and empirical studies, provides the best statistical estimation for analyzing continuous outcomes requiring covariate adjustment. Our empirical findings support the use of ANCOVA as an optimal method in both design and analysis of trials with a continuous primary outcome.Keywords: ANOVA, ANCOVA, change score, knee arthroplasty

  12. Neurodevelopmental outcome at 2 years in twin-twin transfusion syndrome survivors randomized for the Solomon trial.

    Science.gov (United States)

    van Klink, Jeanine M M; Slaghekke, Femke; Balestriero, Marina A; Scelsa, Barbara; Introvini, Paola; Rustico, Mariangela; Faiola, Stefano; Rijken, Monique; Koopman, Hendrik M; Middeldorp, Johanna M; Oepkes, Dick; Lopriore, Enrico

    2016-01-01

    The preferred treatment for twin-twin transfusion syndrome is fetoscopic laser coagulation of inter-twin vascular anastomoses on the monochorionic placenta. Severe postoperative complications can occur when inter-twin vascular anastomoses remain patent including twin-anemia polycythemia sequence or recurrent twin-twin transfusion syndrome. To minimize the occurrence of residual anastomoses, a modified laser surgery technique, the Solomon technique, was developed in which the entire vascular equator is coagulated. In the Solomon randomized controlled trial (NTR1245), the Solomon technique was associated with a significant reduction in twin-anemia polycythemia sequence and recurrence of twin-twin transfusion syndrome when compared with the standard laser surgery technique. Although a significant improvement in perinatal outcome was shown after the Solomon technique, the clinical importance should also be ascertained with long-term follow-up evaluation of the surviving children. The purpose of this study was to compare the long-term neurodevelopmental outcome in surviving children with twin-twin transfusion syndrome who were included in the Solomon randomized trial and treated with either the Solomon technique or standard laser surgery technique. Routine standardized follow-up evaluation in survivors, at least 2 years after the estimated date of delivery, was performed at 2 of the 5 centers that participated in the Solomon trial: Buzzi Hospital Milan (Italy) and Leiden University Medical Center (The Netherlands). The primary outcome of this follow-up study was survival without long-term neurodevelopmental impairment at age 2 years. Neurodevelopmental impairment was defined as cerebral palsy, cognitive and/or motor development score of neurodevelopmental impairment) was detected in 95 of 141 cases (67%) in the Solomon group and in 99 of 146 cases (68%) in the standard group (P = .92). Neurodevelopmental impairment in long-term survivors who were included for follow

  13. A review of the characteristics of dietary fibers relevant to appetite and energy intake outcomes in human intervention trials.

    Science.gov (United States)

    Poutanen, Kaisa S; Dussort, Pierre; Erkner, Alfrun; Fiszman, Susana; Karnik, Kavita; Kristensen, Mette; Marsaux, Cyril Fm; Miquel-Kergoat, Sophie; Pentikäinen, Saara P; Putz, Peter; Slavin, Joanne L; Steinert, Robert E; Mela, David J

    2017-09-01

    Background: Many intervention studies have tested the effect of dietary fibers (DFs) on appetite-related outcomes, with inconsistent results. However, DFs comprise a wide range of compounds with diverse properties, and the specific contribution of these to appetite control is not well characterized. Objective: The influence of specific DF characteristics [i.e., viscosity, gel-forming capacity, fermentability, or molecular weight (MW)] on appetite-related outcomes was assessed in healthy humans. Design: Controlled human intervention trials that tested the effects of well-characterized DFs on appetite ratings or energy intake were identified from a systematic search of literature. Studies were included only if they reported 1 ) DF name and origin and 2 ) data on viscosity, gelling properties, fermentability, or MW of the DF materials or DF-containing matrixes. Results: A high proportion of the potentially relevant literature was excluded because of lack of adequate DF characterization. In total, 49 articles that met these criteria were identified, which reported 90 comparisons of various DFs in foods, beverages, or supplements in acute or sustained-exposure trials. In 51 of the 90 comparisons, the DF-containing material of interest was efficacious for ≥1 appetite-related outcome. Reported differences in material viscosity, MW, or fermentability did not clearly correspond to differences in efficacy, whereas gel-forming DF sources were consistently efficacious (but with very few comparisons). Conclusions: The overall inconsistent relations of DF properties with respect to efficacy may reflect variation in measurement methodology, nature of the DF preparation and matrix, and study designs. Methods of DF characterization, incorporation, and study design are too inconsistent to allow generalized conclusions about the effects of DF properties on appetite and preclude the development of reliable, predictive, structure-function relations. Improved standards for

  14. Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

    Science.gov (United States)

    de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

    2018-05-01

    Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

  15. Personality disorder moderates outcome in short- and long-term group analytic psychotherapy: A randomized clinical trial.

    Science.gov (United States)

    Lorentzen, Steinar; Ruud, Torleif; Fjeldstad, Anette; Høglend, Per A

    2015-06-01

    In a randomized clinical trial, short- and long-term psychodynamic group psychotherapy (STG and LTG, respectively) schedules were equally effective for the 'typical' patient during a 3-year study period. Although several studies have reported good effects for patients with personality disorders (PD) in diverse forms of psychotherapy, the significance of treatment duration is unclear. Therefore, we tested the hypothesis that PD patients would improve more during and after LTG than STG. A randomized, longitudinal, prospective study contrasting the outcomes during and after short- and long-term dynamic group psychotherapies. One hundred and sixty-seven outpatients with mood disorders, anxiety disorders, or PD were randomized to STG or LTG (respectively, 20 or 80 weekly sessions of 90 min each). Outcome measures are as follows: symptoms (SCL-90-R), interpersonal problems (IIP-C), and psychosocial functioning (GAF split version: GAF-Symptom and GAF-Function). PD pathology (number of PD criteria items) was selected a priori as a putative moderator of treatment effects. Change during the 3-year study period was assessed using linear mixed models. The study was registered at ClinicalTrials.gov as NCT 00021417. Our hypothesis was supported, as patients with PD improved significantly more regarding all outcome variables in LTG than STG. For patients without PD, the rate of change was similar across 3 years; however, the rate of change in symptoms and interpersonal problems was higher in STG during the first 6 months. The effectiveness of LTG is higher for patients with co-morbid PD. Patients without PD do not appear to experience additional gain from LTG. Clinical implications: LTG demonstrates better effectiveness than STG for patients with personality disorder co-morbidity (PD). Patients without PD do not appear to experience additional gain from attending LTG. Correct initial allocation to treatment duration may prevent disruptive breaks in relationships and lead to both

  16. Computed tomography scout views vs. conventional radiography in body-packers – Delineation of body-packs and radiation dose in a porcine model

    Energy Technology Data Exchange (ETDEWEB)

    Ziegeler, Edvard, E-mail: edvard.ziegeler@campus.lmu.de [Institute for Clinical Radiology, Ludwig-Maximilians-University Hospital Munich, Nussbaumstraße 20, 80336 Munich (Germany); Grimm, Jochen M., E-mail: jochen.grimm@med.lmu.de [Institute for Clinical Radiology, Ludwig-Maximilians-University Hospital Munich, Nussbaumstraße 20, 80336 Munich (Germany); Wirth, Stefan, E-mail: tefan.wirth@med.lmu.de [Institute for Clinical Radiology, Ludwig-Maximilians-University Hospital Munich, Nussbaumstraße 20, 80336 Munich (Germany); Uhl, Michael, E-mail: michael.uhl@polizei.bayern.de [Bavarian State Criminal Police Office, Maillingerstrasse 15, 80636 Munich (Germany); Reiser, Maximilian F., E-mail: Maximilian.Reiser@med.lmu.de [Institute for Clinical Radiology, Ludwig-Maximilians-University Hospital Munich, Nussbaumstraße 20, 80336 Munich (Germany); Scherr, Michael K., E-mail: Michael.Scherr@med.lmu.de [Institute for Clinical Radiology, Ludwig-Maximilians-University Hospital Munich, Nussbaumstraße 20, 80336 Munich (Germany)

    2012-12-15

    Objective: To compare abdominal computed tomography (CT) scout views with conventional radiography regarding radiation dose and delineation of drug packages in a porcine body-packer model. Materials and methods: Nine samples of illicit drugs packed in ovoid plastic containers were consecutively placed in the rectum of a 121.5 kg pig cadaver. Antero-posterior and lateral scout views were obtained at 120 kVp and 80 mA, 150 mA and 200 mA, respectively, using a 64-row MDCT. Scout views were compared with conventional abdominal antero-posterior radiographs (77 kV and 106 ± 13 mAs). Visibility of three body pack characteristics (wrapping, content, shape) was rated independently by two radiologists and summarized to a delineation score ranging from 0 to 9 with a score ≥6 representing sufficient delineation. Mean delineation scores were calculated for each conventional radiography and single plane scout view separately and for a combined rating of antero-posterior and lateral scout views. Results: Even the lowest single plane scout view delineation score (5.3 ± 2.0 for 80 mA lateral; 0.4 mSv; sensitivity = 44%) was significantly higher than for conventional radiographs (3.1 ± 2.5, p < 0.001; 2.4 ± 0.3 mSv; sensitivity = 11%). Combined reading of antero-posterior and lateral scout views 80 mA yielded sufficient delineation (6.2 ± 1.4; 0.8 mSv; sensitivity = 56%). Conclusions: All CT scout views showed significantly better delineation ratings and sensitivity than conventional radiographs. Scout views in two planes at 80 mA provided a sufficient level of delineation and a sensitivity five times higher than conventional radiography at less than one third of the radiation dose. In case of diagnostic insecurity, CT can be performed without additional logistical effort.

  17. Exercise counseling to enhance smoking cessation outcomes: the Fit2Quit randomized controlled trial.

    Science.gov (United States)

    Maddison, Ralph; Roberts, Vaughan; McRobbie, Hayden; Bullen, Christopher; Prapavessis, Harry; Glover, Marewa; Jiang, Yannan; Brown, Paul; Leung, William; Taylor, Sue; Tsai, Midi

    2014-10-01

    Regular exercise has been proposed as a potential smoking cessation aid. This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks. A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone. There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01). Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services. (Australasian Clinical Trials Registry Number: ACTRN12609000637246.).

  18. Academic Outcomes 2 Years After Working Memory Training for Children With Low Working Memory: A Randomized Clinical Trial.

    Science.gov (United States)

    Roberts, Gehan; Quach, Jon; Spencer-Smith, Megan; Anderson, Peter J; Gathercole, Susan; Gold, Lisa; Sia, Kah-Ling; Mensah, Fiona; Rickards, Field; Ainley, John; Wake, Melissa

    2016-05-02

    Working memory training may help children with attention and learning difficulties, but robust evidence from population-level randomized controlled clinical trials is lacking. To test whether a computerized adaptive working memory intervention program improves long-term academic outcomes of children 6 to 7 years of age with low working memory compared with usual classroom teaching. Population-based randomized controlled clinical trial of first graders from 44 schools in Melbourne, Australia, who underwent a verbal and visuospatial working memory screening. Children were classified as having low working memory if their scores were below the 15th percentile on either the Backward Digit Recall or Mister X subtest from the Automated Working Memory Assessment, or if their scores were below the 25th percentile on both. These children were randomly assigned by an independent statistician to either an intervention or a control arm using a concealed computerized random number sequence. Researchers were blinded to group assignment at time of screening. We conducted our trial from March 1, 2012, to February 1, 2015; our final analysis was on October 30, 2015. We used intention-to-treat analyses. Cogmed working memory training, comprising 20 to 25 training sessions of 45 minutes' duration at school. Directly assessed (at 12 and 24 months) academic outcomes (reading, math, and spelling scores as primary outcomes) and working memory (also assessed at 6 months); parent-, teacher-, and child-reported behavioral and social-emotional functioning and quality of life; and intervention costs. Of 1723 children screened (mean [SD] age, 6.9 [0.4] years), 226 were randomized to each arm (452 total), with 90% retention at 1 year and 88% retention at 2 years; 90.3% of children in the intervention arm completed at least 20 sessions. Of the 4 short-term and working memory outcomes, 1 outcome (visuospatial short-term memory) benefited the children at 6 months (effect size, 0.43 [95% CI, 0

  19. Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

    DEFF Research Database (Denmark)

    Thorlacius, Linnea; Ingram, John R; Garg, Amit

    2017-01-01

    . A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy...... of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online...... Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation. ETHICS AND DISSEMINATION: The study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative...

  20. No difference in outcome for open versus arthroscopic rotator cuff repair: a prospective comparative trial.

    Science.gov (United States)

    Bayle, Xavier; Pham, Thuy-Trang; Faruch, Marie; Gobet, Aurelie; Mansat, Pierre; Bonnevialle, Nicolas

    2017-12-01

    Arthroscopic techniques tend to become the gold standard in rotator cuff repair. However, little data are reported in the literature regarding the improvement of postoperative outcomes and re-tear rate relative to conventional open surgery. The aim of this study was to compare clinical outcomes and cuff integrity after arthroscopic versus open cuff repair. We prospectively assessed clinical outcomes and cuff integrity after an arthroscopic or open rotator cuff repair with a minimum follow-up of 12 months. Clinical evaluation was based on Constant score, Simple Shoulder Value (SSV) and American Shoulder and Elbow Score (ASES). Rotator cuff healing was explored with ultrasound. 44 patients in arthroscopic group A (mean age 56-year-old) and 43 in open group O (mean age 61-year-old) fulfilled the inclusion criteria. Tendons were repaired with a single row technique associated with biceps tenodesis and subacromial decompression. All objective clinical scores significantly improved postoperatively in both groups. No statistical difference was identified between group A and O regarding, respectively, Constant score (72 vs 75 points; p = 0.3), ASES score (88 vs 91 points; p = 0.3), and SSV (81 vs 85%). The overall rate of re-tear (Sugaya type IV or V) reached 7 and 9%, respectively, in group A and O (p = 0.8). This study did not prove any difference of arthroscopic over open surgery in case of rotator cuff repair regarding clinical outcome and cuff integrity at 1-year follow-up. Prospective comparative study.

  1. Screening, intervention and outcome in autism and other developmental disorders: the role of randomized controlled trials

    OpenAIRE

    Fernell, Elisabeth; Wilson, Philip; Hadjikhani, Nouchine; Bourgeron, Thomas; Neville, Brian; Taylor, David; Minnis, Helen; Gillberg, Christopher

    2014-01-01

    We draw attention to a number of important considerations in the arguments about screening and outcome of intervention in children with autism and other developmental disorders. Autism screening in itself never provides a final clinical diagnosis, but may well identify developmental deviations indicative of autism—or of other developmental disorders—that should lead to referral for further clinical assessment. Decisions regarding population or clinic screening cannot be allowed to be based on...

  2. Performance of models for estimating absolute risk difference in multicenter trials with binary outcome

    Directory of Open Access Journals (Sweden)

    Claudia Pedroza

    2016-08-01

    Full Text Available Abstract Background Reporting of absolute risk difference (RD is recommended for clinical and epidemiological prospective studies. In analyses of multicenter studies, adjustment for center is necessary when randomization is stratified by center or when there is large variation in patients outcomes across centers. While regression methods are used to estimate RD adjusted for baseline predictors and clustering, no formal evaluation of their performance has been previously conducted. Methods We performed a simulation study to evaluate 6 regression methods fitted under a generalized estimating equation framework: binomial identity, Poisson identity, Normal identity, log binomial, log Poisson, and logistic regression model. We compared the model estimates to unadjusted estimates. We varied the true response function (identity or log, number of subjects per center, true risk difference, control outcome rate, effect of baseline predictor, and intracenter correlation. We compared the models in terms of convergence, absolute bias and coverage of 95 % confidence intervals for RD. Results The 6 models performed very similar to each other for the majority of scenarios. However, the log binomial model did not converge for a large portion of the scenarios including a baseline predictor. In scenarios with outcome rate close to the parameter boundary, the binomial and Poisson identity models had the best performance, but differences from other models were negligible. The unadjusted method introduced little bias to the RD estimates, but its coverage was larger than the nominal value in some scenarios with an identity response. Under the log response, coverage from the unadjusted method was well below the nominal value (<80 % for some scenarios. Conclusions We recommend the use of a binomial or Poisson GEE model with identity link to estimate RD for correlated binary outcome data. If these models fail to run, then either a logistic regression, log Poisson

  3. An Experimental Trial of Adaptive Programming in Drug Court: Outcomes at 6, 12 and 18 Months.

    Science.gov (United States)

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Benasutti, Kathleen M; Fox, Gloria; Harron, Ashley

    2014-06-01

    Test whether an adaptive program improves outcomes in drug court by adjusting the schedule of court hearings and clinical case-management sessions pursuant to a priori performance criteria. Consenting participants in a misdemeanor drug court were randomly assigned to the adaptive program (n = 62) or to a baseline-matching condition (n = 63) in which they attended court hearings based on the results of a criminal risk assessment. Outcome measures were re-arrest rates at 18 months post-entry to the drug court and urine drug test results and structured interview results at 6 and 12 months post-entry. Although previously published analyses revealed significantly fewer positive drug tests for participants in the adaptive condition during the first 18 weeks of drug court, current analyses indicate the effects converged during the ensuing year. Between-group differences in new arrest rates, urine drug test results and self-reported psychosocial problems were small and non-statistically significant at 6, 12 and 18 months post-entry. A non-significant trend (p = .10) suggests there may have been a small residual impact (Cramer's ν = .15) on new misdemeanor arrests after 18 months. Adaptive programming shows promise for enhancing short-term outcomes in drug courts; however, additional efforts are needed to extend the effects beyond the first 4 to 6 months of enrollment.

  4. Randomised controlled trial of a healthy lifestyle intervention among smokers with psychotic disorders: Outcomes to 36 months.

    Science.gov (United States)

    Baker, Amanda L; Richmond, Robyn; Kay-Lambkin, Frances J; Filia, Sacha L; Castle, David; Williams, Jill M; Lewin, Terry J; Clark, Vanessa; Callister, Robin; Palazzi, Kerrin

    2018-03-01

    People living with psychotic disorders (schizophrenia spectrum and bipolar disorders) have high rates of cardiovascular disease risk behaviours, including smoking, physical inactivity and poor diet. We report cardiovascular disease risk, smoking cessation and other risk behaviour outcomes over 36 months following recruitment into a two-arm randomised controlled trial among smokers with psychotic disorders. Participants ( N = 235) drawn from three sites were randomised to receive nicotine replacement therapy plus (1) a Healthy Lifestyles intervention delivered over approximately 9 months or (2) a largely telephone-delivered intervention (designed to control for nicotine replacement therapy provision, session frequency and other monitoring). The primary outcome variables were 10-year cardiovascular disease risk and smoking status, while the secondary outcomes included weekly physical activity, unhealthy eating, waist circumference, psychiatric symptomatology, depression and global functioning. Significant reductions in cardiovascular disease risk and smoking were detected across the 36-month follow-up period in both intervention conditions, with no significant differences between conditions. One-quarter (25.5%) of participants reported reducing cigarettes per day by 50% or more at multiple post-treatment assessments; however, few (8.9%) managed to sustain this across the majority of time points. Changes in other health behaviours or lifestyle factors were modest; however, significant improvements in depression and global functioning were detected over time in both conditions. Participants experiencing worse 'social discomfort' at baseline (e.g. anxiety, mania, poor self-esteem and social disability) had on average significantly worse global functioning, lower scores on the 12-Item Short Form Health Survey physical scale and significantly greater waist circumference. Although the telephone-delivered intervention was designed as a comparison condition, it

  5. Risk as feelings in the effect of patient outcomes on physicians' future treatment decisions: a randomized trial and manipulation validation.

    Science.gov (United States)

    Hemmerich, Joshua A; Elstein, Arthur S; Schwarze, Margaret L; Moliski, Elizabeth Ghini; Dale, William

    2012-07-01

    The present study tested predictions derived from the Risk as Feelings hypothesis about the effects of prior patients' negative treatment outcomes on physicians' subsequent treatment decisions. Two experiments at The University of Chicago, U.S.A., utilized a computer simulation of an abdominal aortic aneurysm (AAA) patient with enhanced realism to present participants with one of three experimental conditions: AAA rupture causing a watchful waiting death (WWD), perioperative death (PD), or a successful operation (SO), as well as the statistical treatment guidelines for AAA. Experiment 1 tested effects of these simulated outcomes on (n = 76) laboratory participants' (university student sample) self-reported emotions, and their ratings of valence and arousal of the AAA rupture simulation and other emotion-inducing picture stimuli. Experiment 2 tested two hypotheses: 1) that experiencing a patient WWD in the practice trial's experimental condition would lead physicians to choose surgery earlier, and 2) experiencing a patient PD would lead physicians to choose surgery later with the next patient. Experiment 2 presented (n = 132) physicians (surgeons and geriatricians) with the same experimental manipulation and a second simulated AAA patient. Physicians then chose to either go to surgery or continue watchful waiting. The results of Experiment 1 demonstrated that the WWD experimental condition significantly increased anxiety, and was rated similarly to other negative and arousing pictures. The results of Experiment 2 demonstrated that, after controlling for demographics, baseline anxiety, intolerance for uncertainty, risk attitudes, and the influence of simulation characteristics, the WWD experimental condition significantly expedited decisions to choose surgery for the next patient. The results support the Risk as Feelings hypothesis on physicians' treatment decisions in a realistic AAA patient computer simulation. Bad outcomes affected emotions and decisions, even

  6. Outcome when adrenaline (epinephrine) was actually given vs. not given - post hoc analysis of a randomized clinical trial.

    Science.gov (United States)

    Olasveengen, Theresa M; Wik, Lars; Sunde, Kjetil; Steen, Petter A

    2012-03-01

    IV line insertion and drugs did not affect long-term survival in an out-of-hospital cardiac arrest (OHCA) randomized clinical trial (RCT). In a previous large registry study adrenaline was negatively associated with survival from OHCA. The present post hoc analysis on the RCT data compares outcomes for patients actually receiving adrenaline to those not receiving adrenaline. Patients from a RCT performed May 2003 to April 2008 were included. Three patients from the original intention-to-treat analysis were excluded due to insufficient documentation of adrenaline administration. Quality of cardiopulmonary resuscitation (CPR) and clinical outcomes were compared. Clinical characteristics were similar and CPR quality comparable and within guideline recommendations for 367 patients receiving adrenaline and 481 patients not receiving adrenaline. Odds ratio (OR) for being admitted to hospital, being discharged from hospital and surviving with favourable neurological outcome for the adrenaline vs. no-adrenaline group was 2.5 (CI 1.9, 3.4), 0.5 (CI 0.3, 0.8) and 0.4 (CI 0.2, 0.7), respectively. Ventricular fibrillation, response interval, witnessed arrest, gender, age and endotracheal intubation were confounders in multivariate logistic regression analysis. OR for survival for adrenaline vs. no-adrenaline adjusted for confounders was 0.52 (95% CI: 0.29, 0.92). Receiving adrenaline was associated with improved short-term survival, but decreased survival to hospital discharge and survival with favourable neurological outcome after OHCA. This post hoc survival analysis is in contrast to the previous intention-to-treat analysis of the same data, but agrees with previous non-randomized registry data. This shows limitations of non-randomized or non-intention-to-treat analyses. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  7. Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

    Science.gov (United States)

    Chow, Philip I; Ingersoll, Karen S; Thorndike, Frances P; Lord, Holly R; Gonder-Frederick, Linda; Morin, Charles M; Ritterband, Lee M

    2018-07-01

    The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]). Three hundred and three participants (M age  = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period. Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later. Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes. Published by Elsevier B.V.

  8. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial.

    Science.gov (United States)

    Ma, Xiaochen; Zhou, Zhongqiang; Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi; Congdon, Nathan

    2014-09-23

    To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Cluster randomized, investigator masked, controlled trial. 252 primary schools in two prefectures in western China, 2012-13. 3177 of 19,934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity 6/12 with glasses. 3052 (96.0%) completed the study. Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, -0.04 to 0.09) or family wealth (0.01, -0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. The provision of free glasses to Chinese children with myopia improves children's performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and rarely corrected in this setting.Trial Registration

  9. Effects of two physiotherapy booster sessions on outcomes with home exercise in people with knee osteoarthritis: a randomized controlled trial.

    Science.gov (United States)

    Bennell, Kim L; Kyriakides, Mary; Hodges, Paul W; Hinman, Rana S

    2014-11-01

    Enhancing exercise adherence over the longer term is an important goal in self-management of knee osteoarthritis (OA). Following an initial period of more intensive exercise supervision, this study investigated whether 2 additional physiotherapy visits improved outcomes with continued home exercise over a subsequent 24-week period. A total of 78 people with medial knee OA (mean ± SD age 62.1 ± 6.9 years, mean ± SD body mass index 29.4 ± 4.0 kg/m(2) , and radiographic disease severity 19% mild, 49% moderate, and 32% severe) who completed a 12-week physiotherapist-supervised exercise trial were randomly allocated to 2 30-minute physiotherapy booster sessions (delivered by 8 physiotherapists in private clinics) or no booster sessions for the subsequent 24 weeks. All participants were asked to continue home exercises 4 times weekly. Primary outcomes were change in pain, using a 100-mm visual analog scale, and self-reported physical function, measured using the Western Ontario McMaster Universities Osteoarthritis Index. Participants and physiotherapists were unblinded to group allocation, although participants were blinded to the study hypothesis. A total of 74 participants (95%) completed the trial. There was no significant difference between groups for change in pain (mean difference [95% confidence interval (95% CI)] 0.7 mm [-9.4, 8.0]; P = 0.88) or physical function (-0.3 units [95% CI -4.0, 3.5]; P = 0.88). The mean ± SD percentage of home exercise sessions completed was 56% ± 34% in the booster group and 51% ± 37% in the control group (P > 0.05). Two booster sessions with a physiotherapist did not influence pain or physical function outcomes, or measures of home exercise adherence. These findings suggest other more effective strategies are needed to maximize longer-term adherence with the aim to achieve greater improvements in clinical outcomes from exercise in this patient population. Copyright © 2014 by the American College of Rheumatology.

  10. Prem Baby Triple P: a randomised controlled trial of enhanced parenting capacity to improve developmental outcomes in preterm infants.

    Science.gov (United States)

    Colditz, Paul; Sanders, Matthew R; Boyd, Roslyn; Pritchard, Margo; Gray, Peter; O'Callaghan, Michael J; Slaughter, Virginia; Whittingham, Koa; O'Rourke, Peter; Winter, Leanne; Evans, Tracey; Herd, Michael; Ahern, Jessica; Jardine, Luke

    2015-03-04

    Very preterm birth (parenting have the greatest potential to create sustained effects on child development and parental psychopathology. Triple P (Positive Parenting Program) has shown positive effects on child behaviour and adjustment, parenting practices and family functioning. Baby Triple P for Preterm infants, has been developed to target parents of very preterm infants. This study tests the effectiveness of Baby Triple P for Preterm infants in improving child and parent/couple outcomes at 24 months corrected age (CA). Families will be randomised to receive either Baby Triple P for Preterm infants or Care as Usual (CAU). Baby Triple P for Preterm infants involves 4 × 2 hr group sessions at the hospital plus 4 × 30 min telephone consultations soon after transfer (42 weeks C.A.). After discharge participants will be linked to community based Triple P and intervention maintenance up to 24 months C.A. Assessments will be: baseline, post-intervention (6 weeks C.A.), at 12 and 24 months C.A. The primary outcome measure is the Infant Toddler Social & Emotional Assessment (ITSEA) at 24 months C.A. Child behavioural and emotional problems will be coded using the mother-toddler version of the Family Observation Schedule at 24 months C.A. Secondary outcome will be the Bayley Scales of Infant and Toddler Development (BSID III) cognitive development, language and motor abilities. Proximal targets of parenting style, parental self-efficacy, parental mental health, parental adjustment, parent-infant attachment, couple relationship satisfaction and couple communication will also be assessed. Our sample size based on the ITSEA, has 80% power, predicted effect size of 0.33 and an 85% retention rate, requires 165 families are required in each group (total sample of 330 families). This protocol presents the study design, methods and intervention to be analysed in a randomised trial of Baby Triple P for Preterm infants compared to Care as Usual (CAU) for families of very preterm

  11. Study protocol for improving asthma outcomes through cross-cultural communication training for physicians: a randomized trial of physician training.

    Science.gov (United States)

    Patel, Minal R; Thomas, Lara J; Hafeez, Kausar; Shankin, Matthew; Wilkin, Margaret; Brown, Randall W

    2014-06-16

    Massive resources are expended every year on cross-cultural communication training for physicians. Such training is a focus of continuing medical education nationwide and is part of the curriculum of virtually every medical school in America. There is a pressing need for evidence regarding the effects on patients of cross-cultural communication training for physicians. There is a need to understand the added benefit of such training compared to more general communication. We know of no rigorous study that has assessed whether cross-cultural communication training for physicians results in better health outcomes for their patients. The current study aims to answer this question by enhancing the Physician Asthma Care Education (PACE) program to cross cultural communication (PACE Plus), and comparing the effect of the enhanced program to PACE on the health outcomes of African American and Latino/Hispanic children with asthma. A three-arm randomized control trial is used to compare PACE Plus, PACE, and usual care. Both PACE and PACE Plus are delivered in two, two-hour sessions over a period of two weeks to 5-10 primary care physicians who treat African American and Latino/Hispanic children with asthma. One hundred twelve physicians and 1060 of their pediatric patients were recruited who self-identify as African American or Latino/Hispanic and experience persistent asthma. Physicians were randomized into receiving either the PACE Plus or PACE intervention or into the control group. The comparative effectiveness of PACE and PACE Plus on clinician's therapeutic and communication practices with the family/patient, children's urgent care use for asthma, asthma control, and quality of life, and parent/caretaker satisfaction with physician performance will be assessed. Data are collected via telephone survey and medical record review at baseline, 9 months following the intervention, and 21 months following the intervention. This study aims to reduce disparities in asthma

  12. Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees.

    Science.gov (United States)

    Stedman-Smith, Maggie; DuBois, Cathy L Z; Grey, Scott F; Kingsbury, Diana M; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

    2015-04-01

    To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections during the prior 30 days; and (2) related lost work days. Incidence rate ratios calculated using generalized linear mixed models with a Poisson distribution, adjusted for confounders and random cluster effects. A 31% relative reduction in self-reported combined ARI-ILI/GI infections (incidence rate ratio: 0.69; 95% confidence interval, 0.49 to 0.98). A 21% nonsignificant relative reduction in lost work days. An office-based multimodal hand hygiene improvement intervention demonstrated a substantive reduction in self-reported combined ARI-ILI/GI infections.

  13. Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond.

    Science.gov (United States)

    Baldwin, Mike; Spong, Andrew; Doward, Lynda; Gnanasakthy, Ari

    2011-01-01

    Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition of patient-reported information (PRI), which differs from the usual patient-reported outcomes (PRO). These new emergent data from the social web have important implications for decision making, at both an individual and a population level. We discuss new emergent technologies that will help aggregate this information and discuss how this will be assessed alongside the use of PROs in randomized controlled trials and how these new emergent data will be one facet of changing the relationship between the various stakeholders in achieving better co-created health.

  14. Is investigator background related to outcome in head to head trials of psychotherapy and pharmacotherapy for adult depression? A systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Ioana A Cristea

    Full Text Available The influence of factors related to the background of investigators conducting trials comparing psychotherapy and pharmacotherapy has remained largely unstudied. Specializations emphasizing biological determinants of mental disorders, like psychiatry, might favor pharmacotherapy, while others stressing psychosocial factors, like psychology, could promote psychotherapy. Yet financial conflict of interest (COI could be a confounding factor as authors with a medical specialization might receive more sponsoring from the pharmaceutical industry.We conducted a meta-analysis with subgroup and meta-regression analysis examining whether the specialization and affiliation of trial authors were associated to outcomes in the direct comparison of psychotherapy and pharmacotherapy for the acute treatment of depression. Meta-regression analysis also included trial risk of bias and author conflict of interest in relationship to the pharmaceutical industry.We included 45 trials. In half, the first author was psychologist. The last author was psychiatrist/MD in half of the trials, and a psychologist or statistician/other technical in the rest. Most lead authors had medical affiliations. Subgroup analysis indicated that studies with last authors statisticians favored pharmacotherapy. Univariate analysis showed a negative relationship between the presence of statisticians and outcomes favoring psychotherapy. Multivariate analysis showed that trials including authors with financial COI reported findings more favorable to pharmacotherapy.We report the first detailed overview of the background of authors conducting head to head trials for depression. Trials co-authored by statisticians appear to subtly favor pharmacotherapy. Receiving funding from the industry is more closely related to finding better outcomes for the industry's elective treatment than are factors related to authors' background.For a minority of authors we could not retrieve background information

  15. Does enteral nutrition affect clinical outcome? A systematic review of the randomized trials.

    Science.gov (United States)

    Koretz, Ronald L; Avenell, Alison; Lipman, Timothy O; Braunschweig, Carol L; Milne, Anne C

    2007-02-01

    Both parenteral nutrition (PN) and enteral nutrition (EN) are widely advocated as adjunctive care in patients with various diseases. A systematic review of 82 randomized controlled trials (RCTs) of PN published in 2001 found little, if any, effect on mortality, morbidity, or duration of hospital stay; in some situations, PN increased infectious complication rates. The objective was to assess the effect of EN or volitional nutrition support (VNS) in individual disease states from available RCTs. We conducted a systematic review. RCTs comparing EN or VNS with untreated controls, or comparing EN with PN, were identified and separated according to the underlying disease state. Meta-analysis was performed when at least three RCTs provided data. The evidence from the RCTs was summarized into one of five grades. A or B, respectively, indicated the presence of strong or weak (low-quality RCTs) evidence supporting the use of the intervention. C indicated a lack of adequate evidence to make any decision about efficacy. D indicated that limited data could not support the intervention. E indicated either that strong data found no effect, or that either strong or weak data suggested that the intervention caused harm. RCTs could include either hospitalized or nonhospitalized patients. The EN or VNS had to be provided as part of a treatment plan for an underlying disease process. The RCT had to compare recipients of either EN or VNS with controls not receiving any type of artificial nutrition or had to compare recipients of EN with recipients of PN. These were mortality, morbidity (disease specific), duration of hospitalization, cost, or interventional complications. SUMMARY OF GRADING: A: No indication was identified. B: EN or VNS in the perioperative patient or in patients with chronic liver disease; EN in critically ill patients or low birth weight infants (trophic feeding); VNS in malnourished geriatric patients. (The low-quality trials found a significant difference in

  16. Differences in outcomes between GOLD groups in patients with COPD in the TIOSPIR® trial

    DEFF Research Database (Denmark)

    Dusser, Daniel; Wise, Robert A; Dahl, Ronald

    2016-01-01

    BACKGROUND: The aim of this study was to evaluate whether Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification could predict mortality risk factors and whether baseline treatment intensity would relate to mortality within each group, using data from TIOSPIR(®), the largest...... randomized clinical trial in COPD performed to date. METHODS: A total of 17,135 patients from TIOSPIR(®) were pooled and grouped by GOLD grading (A-D) according to baseline Medical Research Council breathlessness score, exacerbation history, and spirometry. All-cause mortality and adjudicated cardiovascular...... (CV) and respiratory mortality were assessed. RESULTS: Of the 16,326 patients classified, 1,248 died on treatment. Group B patients received proportionally more CV treatment at baseline. CV mortality risk, but not all-cause mortality risk, was significantly higher in Group B than Group C patients (CV...

  17. MASCOT—The Mobile Asteroid Surface Scout Onboard the Hayabusa2 Mission

    Science.gov (United States)

    Ho, Tra-Mi; Baturkin, Volodymyr; Grimm, Christian; Grundmann, Jan Thimo; Hobbie, Catherin; Ksenik, Eugen; Lange, Caroline; Sasaki, Kaname; Schlotterer, Markus; Talapina, Maria; Termtanasombat, Nawarat; Wejmo, Elisabet; Witte, Lars; Wrasmann, Michael; Wübbels, Guido; Rößler, Johannes; Ziach, Christian; Findlay, Ross; Biele, Jens; Krause, Christian; Ulamec, Stephan; Lange, Michael; Mierheim, Olaf; Lichtenheldt, Roy; Maier, Maximilian; Reill, Josef; Sedlmayr, Hans-Jürgen; Bousquet, Pierre; Bellion, Anthony; Bompis, Olivier; Cenac-Morthe, Celine; Deleuze, Muriel; Fredon, Stephane; Jurado, Eric; Canalias, Elisabet; Jaumann, Ralf; Bibring, Jean-Pierre; Glassmeier, Karl Heinz; Hercik, David; Grott, Matthias; Celotti, Luca; Cordero, Federico; Hendrikse, Jeffrey; Okada, Tatsuaki

    2017-07-01

    On December 3rd, 2014, the Japanese Space Agency (JAXA) launched successfully the Hayabusa2 (HY2) spacecraft to its journey to Near Earth asteroid (162173) Ryugu. Aboard this spacecraft is a compact landing package, MASCOT (Mobile Asteroid surface SCOuT), which was developed by the German Aerospace Centre (DLR) in collaboration with the Centre National d'Etudes Spatiales (CNES). Similar to the famous predecessor mission Hayabusa, Hayabusa2, will also study an asteroid and return samples to Earth. This time, however, the target is a C-type asteroid which is considered to be more primitive than (25143) Itokawa and provide insight into an even earlier stage of our Solar System.

  18. Scout fourth stage attitude and velocity control (AVC) system feasibility study

    Science.gov (United States)

    Byars, L. B.

    1975-01-01

    The feasibility of incorporating a guidance system in the Scout fourth stage to achieve a significant improvement in expected payload delivery accuracy is studied. The technical investigations included the determination of the AVC equipment performance requirements, establishment of qualification and acceptance test levels, generation of layouts illustrating design approaches for the upper D and payload transition sections to incorporate the hardware, and the preparation of a vendor bid package. Correction concepts, utilizing inertial velocity and attitude, were identified and evaluated. Fourth stage attitude adjustments as determined from inertial velocity variation through the first three stages and a final velocity correction based upon the measured in-plane component errors at injection were employed. Results show radical reductions in apogee-perigee deviations.

  19. Promoting health and activity in the summer trial: Implementation and outcomes of a pilot study

    Directory of Open Access Journals (Sweden)

    E. Whitney Evans

    2018-06-01

    Full Text Available The objectives of this study were to implement, test adherence to and examine the preliminary effectiveness of a summertime weight-gain prevention intervention in youth from a low-income, Rhode Island community. In 2016, 51 children, ages 6–12 years, participated in a daily, summertime intervention, which offered a minimum of two hours of physical activity programming and free lunch through the USDA's Summer Food Service Program (SFSP. Thirty children from the same community with similar SFSP access served as a comparison group. Height and weight were measured before and at the end of summer to assess change in body mass index z-score (BMIz. Diet and physical activity were assessed midsummer. Multivariate mixed models were used to test group differences in change in BMIz over the summer and weight-related behaviors midsummer. Repeated measures ANOVA was used to examine the relationships of intervention participation with change in BMIz and weight-related behaviors in intervention participants. On average, intervention participants attended 65.6% of program sessions. They lost 0.04 BMIz units, while those in the comparison group gained 0.03 BMIz units (p = 0.07. Midsummer, intervention participants spent 4.6% less time sedentary on weekdays as compared to comparison participants (p = 0.03. Among intervention participants, attendance was significantly associated with change in BMIz (p = 0.01, spending 41 more minutes in moderate to vigorous physical activity (MVPA (p = 0.004 and 8.5% less time sedentary (p < 0.001. Implementing a summertime obesity prevention intervention in a low-income community is feasible. Despite moderate adherence, preliminary findings suggest that participation in the intervention was associated with reductions in BMIz. Clinical trials registration: ClinicalTrials.gov NCT03118635 Keywords: Childhood obesity, Summer, Low-income, Diet, Physical activity

  20. Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration.

    Science.gov (United States)

    Deemer, Ashley D; Massof, Robert W; Rovner, Barry W; Casten, Robin J; Piersol, Catherine V

    2017-03-01

    To compare the efficacy of behavioral activation (BA) plus low vision rehabilitation with an occupational therapist (OT-LVR) with supportive therapy (ST) on visual function in patients with age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized clinical trial with AMD patients with subsyndromal depressive symptoms (n = 188). All subjects had two outpatient low vision rehabilitation optometry visits, then were randomized to in-home BA + OT-LVR or ST. Behavioral activation is a structured behavioral treatment aiming to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. Functional vision was assessed with the activity inventory (AI) in which participants rate the difficulty level of goals and corresponding tasks. Participants were assessed at baseline and 4 months. Improvements in functional vision measures were seen in both the BA + OT-LVR and ST groups at the goal level (d = 0.71; d = 0.56 respectively). At the task level, BA + OT-LVR patients showed more improvement in reading, inside-the-home tasks and outside-the-home tasks, when compared to ST patients. The greatest effects were seen in the BA + OT-LVR group in subjects with a visual acuity ≥20/70 (d = 0.360 reading; d = 0.500 inside the home; d = 0.468 outside the home). Based on the trends of the AI data, we suggest that BA + OT-LVR services, provided by an OT in the patient's home following conventional low vision optometry services, are more effective than conventional optometric low vision services alone for those with mild visual impairment. (ClinicalTrials.gov number, NCT00769015.).

  1. Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study.

    Science.gov (United States)

    Weiss, Roger D; Potter, Jennifer Sharpe; Griffin, Margaret L; Provost, Scott E; Fitzmaurice, Garrett M; McDermott, Katherine A; Srisarajivakul, Emily N; Dodd, Dorian R; Dreifuss, Jessica A; McHugh, R Kathryn; Carroll, Kathleen M

    2015-05-01

    Despite the growing prevalence of prescription opioid dependence, longitudinal studies have not examined long-term treatment response. The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study (POATS). POATS was a multi-site clinical trial lasting up to 9 months, examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence, with participants randomized to receive or not receive additional opioid drug counseling. A subset of participants (N=375 of 653) enrolled in a follow-up study. Telephone interviews were administered approximately 18, 30, and 42 months after main-trial enrollment. Comparison of baseline characteristics by follow-up participation suggested few differences. At Month 42, much improvement was seen: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy, but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; and the remaining 31.4% were using opioids without agonist therapy. Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 (OR=4.56, 95% CI=1.29-16.04, popioid abstinence. Eight percent (n=27/338) used heroin for the first time during follow-up; 10.1% reported first-time injection heroin use. Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. However, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  2. Do cognitive measures and brain circuitry predict outcomes of exercise in Parkinson Disease: a randomized clinical trial.

    Science.gov (United States)

    King, L A; Peterson, D S; Mancini, M; Carlson-Kuhta, P; Fling, B W; Smulders, K; Nutt, J G; Dale, M; Carter, J; Winters-Stone, K M; Horak, F B

    2015-10-24

    There is emerging research detailing the relationship between balance/gait/falls and cognition. Imaging studies also suggest a link between structural and functional changes in the frontal lobe (a region commonly associated with cognitive function) and mobility. People with Parkinson's disease have important changes in cognitive function that may impact rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal lobe connections with the basal ganglia and brainstem posture/locomotor centers are responsible for postural deficits in people with Parkinson's disease and play a role in rehabilitation efficacy. The purpose of this study is to 1) determine if people with Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively challenging mobility exercise program and 2) determine if cognition and brain circuitry deficits predict responsiveness to exercise rehabilitation. This study is a randomized cross-over controlled intervention to take place at a University Balance Disorders Laboratory. The study participants will be people with Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6 weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a cognitively challenging program based on the Agility Boot Camp for people with PD. The education program is a 6-week program to teach people how to better live with a chronic disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are measures of mobility, cognition and neural imaging. The results from this study will further our understanding of the relationship between cognition and mobility with a focus on brain circuitry as it relates to rehabilitation potential. This trial is registered at clinical trials.gov (NCT02231073).

  3. Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial.

    Science.gov (United States)

    Hartescu, Iuliana; Morgan, Kevin; Stevinson, Clare D

    2015-10-01

    While high levels of activity and exercise training have been associated with improvements in sleep quality, minimum levels of activity likely to improve sleep outcomes have not been explored. A two-armed parallel randomized controlled trial (N=41; 30 females) was designed to assess whether increasing physical activity to the level recommended in public health guidelines can improve sleep quality among inactive adults meeting research diagnostic criteria for insomnia. The intervention consisted of a monitored program of ≥150 min of moderate- to vigorous-intensity physical activity per week, for 6 months. The principal end-point was the Insomnia Severity Index at 6 months post-baseline. Secondary outcomes included measures of mood, fatigue and daytime sleepiness. Activity and light exposure were monitored throughout the trial using accelerometry and actigraphy. At 6 months post-baseline, the physical activity group showed significantly reduced insomnia symptom severity (F(8,26) = 5.16, P = 0.03), with an average reduction of four points on the Insomnia Severity Index; and significantly reduced depression and anxiety scores (F(6,28) = 5.61, P = 0.02; and F(6,28) = 4.41, P = 0.05, respectively). All of the changes were independent of daily light exposure. Daytime fatigue showed no significant effect of the intervention (F(8,26) = 1.84, P = 0.18). Adherence and retention were high. Internationally recommended minimum levels of physical activity improve daytime and night-time symptoms of chronic insomnia independent of daily light exposure levels. © 2015 European Sleep Research Society.

  4. Effect of Behavior Modification on Outcome in Early- to Moderate-Stage Chronic Kidney Disease: A Cluster-Randomized Trial.

    Science.gov (United States)

    Yamagata, Kunihiro; Makino, Hirofumi; Iseki, Kunitoshi; Ito, Sadayoshi; Kimura, Kenjiro; Kusano, Eiji; Shibata, Takanori; Tomita, Kimio; Narita, Ichiei; Nishino, Tomoya; Fujigaki, Yoshihide; Mitarai, Tetsuya; Watanabe, Tsuyoshi; Wada, Takashi; Nakamura, Teiji; Matsuo, Seiichi

    2016-01-01

    Owing to recent changes in our understanding of the underlying cause of chronic kidney disease (CKD), the importance of lifestyle modification for preventing the progression of kidney dysfunction and complications has become obvious. In addition, effective cooperation between general physicians (GPs) and nephrologists is essential to ensure a better care system for CKD treatment. In this cluster-randomized study, we studied the effect of behavior modification on the outcome of early- to moderate-stage CKD. Stratified open cluster-randomized trial. A total of 489 GPs belonging to 49 local medical associations (clusters) in Japan. A total of 2,379 patients (1,195 in group A (standard intervention) and 1,184 in group B (advanced intervention)) aged between 40 and 74 years, who had CKD and were under consultation with GPs. All patients were managed in accordance with the current CKD guidelines. The group B clusters received three additional interventions: patients received both educational intervention for lifestyle modification and a CKD status letter, attempting to prevent their withdrawal from treatment, and the group B G