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

ERIC Educational Resources Information Center

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

2009-01-01

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

Findings from a Multiyear Scale-Up Effectiveness Trial of Open Court Reading

ERIC Educational Resources Information Center

Vaden-Kiernan, Michael; Borman, Geoffrey; Caverly, Sarah; Bell, Nance; Sullivan, Kate; Ruiz de Castilla, Veronica; Fleming, Grace; Rodriguez, Debra; Henry, Chad; Long, Tracy; Hughes Jones, Debra

2018-01-01

This multiyear scale-up effectiveness study of Open Court Reading (OCR) involved approximately 4,500 students and more than 1,000 teachers per year in Grades K-5 from 49 elementary schools in seven districts across the country. Using a school-level cluster randomized trial design, we assessed the implementation and effectiveness of Open Court…

WWC Review of the Report "Same-Language-Subtitling (SLS): Using Subtitled Music Video for Reading Growth". What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2013

2013-01-01

This randomized controlled trial examined the impacts of "Same-Language-Subtitling" ("SLS"), a karaoke-style subtitling intervention, on the reading comprehension skills of secondary school students in Kaneohe, Hawaii. Researchers randomly assigned 198 secondary school students with learning disabilities (ages 14 to 19) to…

Comparing Treatments for Children with ADHD and Word Reading Difficulties: A Randomized Clinical Trial

PubMed Central

Tamm, Leanne; Denton, Carolyn A.; Epstein, Jeffery N.; Schatschneider, Christopher; Taylor, Heather; Arnold, L. Eugene; Bukstein, Oscar; Anixt, Julia; Koshy, Anson; Newman, Nicholas C.; Maltinsky, Jan; Brinson, Patricia; Loren, Richard; Prasad, Mary R.; Ewing-Cobbs, Linda; Vaughn, Aaron

2017-01-01

Objective This randomized clinical trial compared Attention-Deficit/Hyperactivity Disorder (ADHD) treatment alone, intensive reading intervention alone, and their combination for children with ADHD and word reading difficulties and disabilities (RD). Method Children (n=216; predominantly African American males) in grades 2–5 with ADHD and word reading/decoding deficits were randomized to ADHD treatment (carefully-managed medication+parent training), reading treatment (intensive reading instruction), or combined ADHD+reading treatment. Outcomes were parent and teacher ADHD ratings and measures of word reading/decoding. Analyses utilized a mixed models covariate-adjusted gain score approach with post-test regressed onto pretest and other predictors. Results Inattention and hyperactivity/impulsivity outcomes were significantly better in the ADHD (parent Hedges g=.87/.75; teacher g=.67/.50) and combined (parent g=1.06/.95; teacher g=.36/41) treatment groups than reading treatment alone; the ADHD and Combined groups did not differ significantly (parent g=.19/.20; teacher g=.31/.09). Word reading and decoding outcomes were significantly better in the reading (word reading g=.23; decoding g=.39) and combined (word reading g=.32; decoding g=.39) treatment groups than ADHD treatment alone; reading and combined groups did not differ (word reading g=.09; decoding g=.00). Significant group differences were maintained at the three- to five-month follow-up on all outcomes except word reading. Conclusions Children with ADHD and RD benefit from specific treatment of each disorder. ADHD treatment is associated with more improvement in ADHD symptoms than RD treatment, and reading instruction is associated with better word reading and decoding outcomes than ADHD treatment. The additive value of combining treatments was not significant within disorder, but the combination allows treating both disorders simultaneously. PMID:28333510

A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

ERIC Educational Resources Information Center

Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

2009-01-01

This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

Improving Content Knowledge and Comprehension for English Language Learners: Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Vaughn, Sharon; Martinez, Leticia R.; Wanzek, Jeanne; Roberts, Greg; Swanson, Elizabeth; Fall, Anna-Mária

2017-01-01

Supporting the reading comprehension and content knowledge acquisition of English language learners (ELs) requires instructional practices that continue beyond developing the foundational skills of reading. In particular, the challenges ELs face highlight the importance of teaching reading comprehension practices in the middle grades through…

Randomized controlled trial on the effects of training in the use of closed-circuit television on reading performance.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Hoeben, Frank P; Knol, Dirk L; van Rens, Ger H M B

2012-04-24

To investigate the effectiveness of training in the use of closed-circuit television (CCTV) on reading performance in visually impaired patients. In a multicenter masked randomized controlled trial, 122 patients were randomized either to a treatment group that received usual delivery instructions from the CCTV supplier combined with concise outpatient standardized training, or to a control group that received delivery instructions only. The main outcome measure was reading performance, which was obtained by measuring reading acuity, reading speed, reading errors, column-tracking time, and technical reading, approximately two weeks after patients had received their CCTV and 3 months later. Videotapes of all measurements were rated by two investigators. Training effects were analyzed with linear mixed modeling. There were no statistically significant differences in results between the treatment and control group. However, introducing a CCTV increased reading acuity (mean difference [MD] 0.93 logRAD; P < 0.01) and maximum reading speed (MD 15 wpm; P < 0.01), and decreased the number of errors (MD 0.33; P = 0.04), compared to reading without CCTV. Average reading speed (P = 0.05), number of errors (P = 0.04), and column-tracking time (P = 0.01) improved over time. Prescribing a CCTV and the delivery instructions by the supplier seemed sufficient to improve reading performance. Additional training in the use of this device did not result in further improvement. Based on these results, outpatient low-vision rehabilitation centers may consider reallocating part of the training resources into other evidence-based rehabilitation programs. (trialregister.nl number, NTR1031.).

Involving Parents in Paired Reading with Preschoolers: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Lam, Shui-fong; Chow-Yeung, Kamfung; Wong, Bernard P. H.; Lau, Kwok Kiu; Tse, Shuk In

2013-01-01

A paired reading program was implemented for 195 Hong Kong preschoolers (mean age = 4.7 years) and their parents from families with a wide range of family income. The preschoolers were randomly assigned to experimental or waitlist control groups. The parents in the experimental group received 12 sessions of school-based training on paired reading…

Effect of Atomoxetine Treatment on Reading and Phonological Skills in Children with Dyslexia or Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia in a Randomized, Placebo-Controlled Trial.

PubMed

Shaywitz, Sally; Shaywitz, Bennett; Wietecha, Linda; Wigal, Sharon; McBurnett, Keith; Williams, David; Kronenberger, William G; Hooper, Stephen R

2017-02-01

Evaluated the effects of atomoxetine on the reading abilities of children with dyslexia only or attention-deficit/hyperactivity disorder (ADHD) and comorbid dyslexia. Children aged 10-16 years (N = 209) met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for dyslexia only (n = 58), ADHD and comorbid dyslexia (n = 124), or ADHD only (n = 27) and were of normal intelligence. Patients were treated with atomoxetine (1.0-1.4 mg/kg/day) or placebo in a 16-week, randomized, placebo-controlled, double-blind trial. The dyslexia-only and ADHD and comorbid dyslexia groups were randomized 1:1; the ADHD-only group received atomoxetine in a blinded manner. Reading abilities were measured with the Woodcock Johnson III (WJIII), Comprehensive Test of Phonological Processing (CTOPP), Gray Oral Reading Tests-4, and Test of Word Reading Efficiency. Atomoxetine-treated dyslexia-only patients compared with placebo patients had significantly greater improvement (p < 0.02) with moderate to approaching high effect sizes (ES) on WJIII Word Attack (ES = 0.72), Basic Reading Skills (ES = 0.48), and Reading Vocabulary (ES = 0.73). In the atomoxetine-treated ADHD and comorbid dyslexia group, improvement on the CTOPP Elision measure (ES = 0.50) was significantly greater compared with placebo (p < 0.02). Total, inattentive, and hyperactive/impulsive ADHD symptom reductions were significant in the atomoxetine-treated ADHD and comorbid dyslexia group compared with placebo, and from baseline in the ADHD-only group (p ≤ 0.02). ADHD symptom improvements in the ADHD and comorbid dyslexia group were not correlated with improvements in reading. Atomoxetine treatment improved reading scores in patients with dyslexia only and ADHD and comorbid dyslexia. Improvements for patients with dyslexia only were in critical components of reading, including decoding and reading vocabulary. For patients with ADHD and comorbid dyslexia, improvements in reading scores were distinct from improvement in ADHD inattention symptoms alone. These data represent the first report of improvements in reading measures following pharmacotherapy treatment in patients with dyslexia only evaluated in a randomized, double-blind trial.

Effect of Atomoxetine Treatment on Reading and Phonological Skills in Children with Dyslexia or Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia in a Randomized, Placebo-Controlled Trial

PubMed Central

Shaywitz, Bennett; Wietecha, Linda; Wigal, Sharon; McBurnett, Keith; Williams, David; Kronenberger, William G.; Hooper, Stephen R.

2017-01-01

Abstract Objectives: Evaluated the effects of atomoxetine on the reading abilities of children with dyslexia only or attention-deficit/hyperactivity disorder (ADHD) and comorbid dyslexia. Methods: Children aged 10–16 years (N = 209) met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for dyslexia only (n = 58), ADHD and comorbid dyslexia (n = 124), or ADHD only (n = 27) and were of normal intelligence. Patients were treated with atomoxetine (1.0–1.4 mg/kg/day) or placebo in a 16-week, randomized, placebo-controlled, double-blind trial. The dyslexia-only and ADHD and comorbid dyslexia groups were randomized 1:1; the ADHD-only group received atomoxetine in a blinded manner. Reading abilities were measured with the Woodcock Johnson III (WJIII), Comprehensive Test of Phonological Processing (CTOPP), Gray Oral Reading Tests-4, and Test of Word Reading Efficiency. Results: Atomoxetine-treated dyslexia-only patients compared with placebo patients had significantly greater improvement (p < 0.02) with moderate to approaching high effect sizes (ES) on WJIII Word Attack (ES = 0.72), Basic Reading Skills (ES = 0.48), and Reading Vocabulary (ES = 0.73). In the atomoxetine-treated ADHD and comorbid dyslexia group, improvement on the CTOPP Elision measure (ES = 0.50) was significantly greater compared with placebo (p < 0.02). Total, inattentive, and hyperactive/impulsive ADHD symptom reductions were significant in the atomoxetine-treated ADHD and comorbid dyslexia group compared with placebo, and from baseline in the ADHD-only group (p ≤ 0.02). ADHD symptom improvements in the ADHD and comorbid dyslexia group were not correlated with improvements in reading. Conclusions: Atomoxetine treatment improved reading scores in patients with dyslexia only and ADHD and comorbid dyslexia. Improvements for patients with dyslexia only were in critical components of reading, including decoding and reading vocabulary. For patients with ADHD and comorbid dyslexia, improvements in reading scores were distinct from improvement in ADHD inattention symptoms alone. These data represent the first report of improvements in reading measures following pharmacotherapy treatment in patients with dyslexia only evaluated in a randomized, double-blind trial. PMID:27410907

The Effects of Collaborative Strategic Reading Instruction on the Reading Comprehension of Middle School Students: Year 2 Replication

ERIC Educational Resources Information Center

Swanson, Elizabeth; Mohammed, Sarojani S.; Boardman, Alison Gould; Vaughn, Sharon; Klingner, Janette; Roberts, Greg; Leroux, Audrey; Solis, Michael

2011-01-01

The current study is the second in a series of multi-site, multi-year randomized control trials designed to test the efficacy of a fully developed intervention, Collaborative Strategic Reading (CSR), with adolescent readers. In year 1, the research questions were: (1) Does CSR improve reading comprehension for adolescent readers attending…

Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

ERIC Educational Resources Information Center

Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

2014-01-01

This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

The Effects of Teacher Read-Alouds and Student Silent Reading on Predominantly Bilingual High School Seniors' Learning and Retention of Social Studies Content

ERIC Educational Resources Information Center

Reed, Deborah K.; Swanson, Elizabeth; Petscher, Yaacov; Vaughn, Sharon

2014-01-01

Teacher read-alouds (TRA) are common in middle and high school content area classes. Because the practice of reading the textbook out loud to students is often used out of concern about students' ability to understand and learn from text when reading silently (SR), this randomized controlled trial was designed to experimentally manipulate text…

The Targeted Reading Intervention: Face-to-Face vs. Webcam Literacy Coaching of Classroom Teachers

ERIC Educational Resources Information Center

Vernon-Feagans, L.; Bratsch-Hines, M.; Varghese, C.; Bean, A.; Hedrick, A.

2015-01-01

The targeted reading intervention (TRI) is a professional development program for rural kindergarten and first grade classroom teachers to help them provide effective reading strategies with struggling readers. In two randomized controlled trials, the TRI was delivered two ways: (1) literacy coaches provided support for classroom teachers through…

Collaborative Strategic Reading: Replications with Consideration of the Role of Fidelity

ERIC Educational Resources Information Center

Vaughn, Sharon; Roberts, Greg; Reutebuch, Colleen

2013-01-01

Collaborative Strategic Reading (CSR) is a multicomponent reading intervention aimed at improving students' text comprehension. Two 1-year randomized controlled trials were conducted to determine the efficacy of CSR with seventh and eighth grade students. The Year 2 replication study was identical to the original Year 1 study except that the…

Increasing Young Children's Contact with Print during Shared Reading: Longitudinal Effects on Literacy Achievement

ERIC Educational Resources Information Center

Piasta, Shayne B.; Justice, Laura M.; McGinty, Anita S.; Kaderavek, Joan N.

2012-01-01

Longitudinal results for a randomized-controlled trial (RCT) assessing the impact of increasing preschoolers' attention to print during reading are reported. Four-year-old children (N = 550) in 85 classrooms experienced a 30-week shared reading program implemented by their teachers. Children in experimental classrooms experienced shared-book…

The Efficacy of PCI's "Reading Program--Level One": A Report of a Randomized Experiment in Brevard Public Schools and Miami-Dade County Public Schools. Research Report

ERIC Educational Resources Information Center

Toby, Megan; Ma, Boya; Jaciw, Andrew; Cabalo, Jessica

2008-01-01

PCI Education sought scientifically based evidence on the effectiveness of the "PCI Reading Program--Level One" for students with severe disabilities. During the 2007-2008 academic year. Empirical Education conducted a randomized control trial (RCT) in two Florida districts, Brevard and Miami-Dade County Public Schools. For this…

Year One Results from the Multisite Randomized Evaluation of the i3 Scale-Up of Reading Recovery

ERIC Educational Resources Information Center

May, Henry; Gray, Abigail; Sirinides, Philip; Goldsworthy, Heather; Armijo, Michael; Sam, Cecile; Gillespie, Jessica N.; Tognatta, Namrata

2015-01-01

Reading Recovery (RR) is a short-term, one-to-one intervention designed to help the lowest achieving readers in first grade. This article presents first-year results from the multisite randomized controlled trial (RCT) and implementation study under the $55 million Investing in Innovation (i3) Scale-Up Project. For the 2011-2012 school year, the…

The Efficacy of PCI's Reading Program--Level One: A Report of a Randomized Experiment in Brevard Public Schools and Miami-Dade County Public Schools. Research Summary

ERIC Educational Resources Information Center

Empirical Education Inc., 2008

2008-01-01

PCI Education sought scientifically based evidence on the effectiveness of the "PCI Reading Program--Level One" for students with severe disabilities. During the 2007-2008 academic year. Empirical Education conducted a randomized control trial (RCT) in two Florida districts, Brevard and Miami-Dade County Public Schools. For this…

Docosahexaenoic acid for reading, cognition and behavior in children aged 7-9 years: a randomized, controlled trial (the DOLAB Study).

PubMed

Richardson, Alexandra J; Burton, Jennifer R; Sewell, Richard P; Spreckelsen, Thees F; Montgomery, Paul

2012-01-01

Omega-3 fatty acids are dietary essentials, and the current low intakes in most modern developed countries are believed to contribute to a wide variety of physical and mental health problems. Evidence from clinical trials indicates that dietary supplementation with long-chain omega-3 may improve child behavior and learning, although most previous trials have involved children with neurodevelopmental disorders such as attention-deficit/hyperactivity disorder (ADHD) or developmental coordination disorder (DCD). Here we investigated whether such benefits might extend to the general child population. To determine the effects of dietary supplementation with the long-chain omega-3 docosahexaenoic acid (DHA) on the reading, working memory, and behavior of healthy schoolchildren. Parallel group, fixed-dose, randomized, double-blind, placebo-controlled trial (RCT). Mainstream primary schools in Oxfordshire, UK (n = 74). Healthy children aged 7-9 years initially underperforming in reading (≤ 33(rd) centile). 1376 invited, 362 met study criteria. 600 mg/day DHA (from algal oil), or taste/color matched corn/soybean oil placebo. Age-standardized measures of reading, working memory, and parent- and teacher-rated behavior. ITT analyses showed no effect of DHA on reading in the full sample, but significant effects in the pre-planned subgroup of 224 children whose initial reading performance was ≤ 20(th) centile (the target population in our original study design). Parent-rated behavior problems (ADHD-type symptoms) were significantly reduced by active treatment, but little or no effects were seen for either teacher-rated behaviour or working memory. DHA supplementation appears to offer a safe and effective way to improve reading and behavior in healthy but underperforming children from mainstream schools. Replication studies are clearly warranted, as such children are known to be at risk of low educational and occupational outcomes in later life. ClinicalTrials.gov NCT01066182 and Controlled-Trials.com ISRCTN99771026.

A Randomized Study of a Literacy-Integrated Science Intervention for Low-Socio-Economic Status Middle School Students: Findings from First-Year Implementation

ERIC Educational Resources Information Center

Tong, Fuhui; Irby, Beverly J.; Lara-Alecio, Rafael; Guerrero, Cindy; Fan, Yinan; Huerta, Margarita

2014-01-01

This paper presents the findings from a randomized control trial study of reading/literacy-integrated science inquiry intervention after 1 year of implementation and the treatment effect on 5th-grade low-socio-economic African-American and Hispanic students' achievement in science and English reading. A total of 94 treatment students and 194…

Enhancing the Interpretive Reading and Analytical Writing of Mainstreamed English Learners in Secondary School: Results from a Randomized Field Trial Using a Cognitive Strategies Approach

ERIC Educational Resources Information Center

Olson, Carol Booth; Kim, James S.; Scarcella, Robin; Kramer, Jason; Pearson, Matthew; van Dyk, David A.; Collins, Penny; Land, Robert E.

2012-01-01

In this study, 72 secondary English teachers from the Santa Ana Unified School District were randomly assigned to participate in the Pathway Project, a cognitive strategies approach to teaching interpretive reading and analytical writing, or to a control condition involving typical district training focusing on teaching content from the textbook.…

Using Regression Discontinuity to Test the Impact of a Tier 2 Reading Intervention in First Grade

ERIC Educational Resources Information Center

Baker, Scott K.; Smolkowski, Keith; Chaparro, Erin A.; Smith, Jean L. M.; Fien, Hank

2015-01-01

Multitiered systems of reading instruction and intervention, including response to intervention, are widely used in early reading by schools to provide more intense services to students who need them. Research using randomized controlled trials has compared innovative Tier 2 interventions to business-as-usual Tier 2 approaches and established a…

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Implementing Mother Tongue Instruction in the Real World: Results from a Medium-Scale Randomized Controlled Trial in Kenya

ERIC Educational Resources Information Center

Piper, Benjamin; Zuilkowski, Stephanie S.; Ong'ele, Salome

2016-01-01

Research in sub-Saharan Africa investigating the effect of mother tongue (MT) literacy instruction at medium scale is limited. A randomized controlled trial of MT literacy instruction was implemented in 2013 and 2014 as part of the Primary Math and Reading (PRIMR) Initiative in Kenya. We compare the effect of two treatment groups--the base PRIMR…

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

PubMed

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

2018-04-13

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

Replicating the Effects of a Teacher-Scaffolded Voluntary Summer Reading Program: The Role of Poverty

ERIC Educational Resources Information Center

White, Thomas G.; Kim, James S.; Kingston, Helen Chen; Foster, Lisa

2014-01-01

A randomized trial involving 19 elementary schools (K-5) was conducted to replicate and extend two previous experimental studies of the effects of a voluntary summer reading program that provided (a) books matched to students' reading levels and interests and (b) teacher scaffolding in the form of end-of-year comprehension lessons. Matched…

A Randomized Controlled Trial on The Beneficial Effects of Training Letter-Speech Sound Integration on Reading Fluency in Children with Dyslexia

PubMed Central

Fraga González, Gorka; Žarić, Gojko; Tijms, Jurgen; Bonte, Milene; van der Molen, Maurits W.

2015-01-01

A recent account of dyslexia assumes that a failure to develop automated letter-speech sound integration might be responsible for the observed lack of reading fluency. This study uses a pre-test-training-post-test design to evaluate the effects of a training program based on letter-speech sound associations with a special focus on gains in reading fluency. A sample of 44 children with dyslexia and 23 typical readers, aged 8 to 9, was recruited. Children with dyslexia were randomly allocated to either the training program group (n = 23) or a waiting-list control group (n = 21). The training intensively focused on letter-speech sound mapping and consisted of 34 individual sessions of 45 minutes over a five month period. The children with dyslexia showed substantial reading gains for the main word reading and spelling measures after training, improving at a faster rate than typical readers and waiting-list controls. The results are interpreted within the conceptual framework assuming a multisensory integration deficit as the most proximal cause of dysfluent reading in dyslexia. Trial Registration: ISRCTN register ISRCTN12783279 PMID:26629707

National Assessment of Title I: Interim Report. Volume II: Closing the Reading Gap: First Year Findings from a Randomized Trial of Four Reading Interventions for Striving Readers

ERIC Educational Resources Information Center

Torgesen, Joseph; Myers, David; Schirm, Allen; Stuart, Elizabeth; Vartivarian, Sonya; Mansfield, Wendy; Stancavage, Fran; Durno, Donna; Javorsky, Rosanne; Haan, Cinthia

2006-01-01

According to the National Assessment of Educational Progress, nearly 4 in 10 fourth graders read below the basic level. These literacy problems get worse as students advance through school and are exposed to progressively more complex concepts and courses. The purpose of this study was to assess the effectiveness of four remedial reading programs…

Contexts for Teacher Practice: (Re)Considering the Role of Context in Interventions in Early Childhood Teacher Engagement with New Approaches to Shared Book Reading

ERIC Educational Resources Information Center

Delaney, Katherine K.; Neuman, Susan B.

2016-01-01

Although the randomized controlled trial has been regarded as the "sine qua non" in recent years, we argue that understanding contexts for teacher practice is a critical factor in the implementation of intervention, but has often been overlooked in educational research design. In this paper, we argue that randomized trials may not be…

Do children with reading delay benefit from the use of personal FM systems in the classroom?

PubMed

Purdy, Suzanne C; Smart, Jennifer L; Baily, Melissa; Sharma, Mridula

2009-12-01

FM systems have been used to compensate for poor signal-to-noise ratios in classrooms. This study evaluates benefits of a 6-week trial of personal FM systems used during the school day for children with reading delay aged 6-11 years, using a randomized control design. Teachers and children completed the LIFE-UK questionnaire. Test-retest reliability of the LIFE-UK children's version was confirmed in a separate group of 18 children from the same school. The 23 children in the FM group had significantly improved teacher ratings, and the children's ratings of classroom listening for difficult situations were significantly better after the trial. These changes did not occur for the 23 control-group children. Most children (92%) commented positively about the FM after the trial. It is likely that a longer FM trial or a specific reading intervention combined with FM will be required for the benefits of enhanced listening to affect performance on standardized reading tests.

Comparing treatments for children with ADHD and word reading difficulties: A randomized clinical trial.

PubMed

Tamm, Leanne; Denton, Carolyn A; Epstein, Jeffery N; Schatschneider, Christopher; Taylor, Heather; Arnold, L Eugene; Bukstein, Oscar; Anixt, Julia; Koshy, Anson; Newman, Nicholas C; Maltinsky, Jan; Brinson, Patricia; Loren, Richard E A; Prasad, Mary R; Ewing-Cobbs, Linda; Vaughn, Aaron

2017-05-01

This trial compared attention-deficit/hyperactivity disorder (ADHD) treatment alone, intensive reading intervention alone, and their combination for children with ADHD and word reading difficulties and disabilities (RD). Children (n = 216; predominantly African American males) in Grades 2-5 with ADHD and word reading/decoding deficits were randomized to ADHD treatment (medication + parent training), reading treatment (reading instruction), or combined ADHD + reading treatment. Outcomes were parent and teacher ADHD ratings and measures of word reading/decoding. Analyses utilized a mixed models covariate-adjusted gain score approach with posttest regressed onto pretest. Inattention and hyperactivity/impulsivity outcomes were significantly better in the ADHD (parent Hedges's g = .87/.75; teacher g = .67/.50) and combined (parent g = 1.06/.95; teacher g = .36/41) treatment groups than reading treatment alone; the ADHD and Combined groups did not differ significantly (parent g = .19/.20; teacher g = .31/.09). Word reading and decoding outcomes were significantly better in the reading (word reading g = .23; decoding g = .39) and combined (word reading g = .32; decoding g = .39) treatment groups than ADHD treatment alone; reading and combined groups did not differ (word reading g = .09; decoding g = .00). Significant group differences were maintained at the 3- to 5-month follow-up on all outcomes except word reading. Children with ADHD and RD benefit from specific treatment of each disorder. ADHD treatment is associated with more improvement in ADHD symptoms than RD treatment, and reading instruction is associated with better word reading and decoding outcomes than ADHD treatment. The additive value of combining treatments was not significant within disorder, but the combination allows treating both disorders simultaneously. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Efficacy of Learning Strategies Instruction in Adult Education

ERIC Educational Resources Information Center

Hock, Michael F.; Mellard, Daryl F.

2011-01-01

Results from randomized controlled trials of learning strategies instruction with 375 adult basic education participants are reported. Reading outcomes from whole group strategic instruction in 1 of 4 learning strategies were compared to outcomes of reading instruction delivered in the context of typical adult education units on social studies,…

The Relative Impact of Aligning Tier 2 Intervention Materials with Classroom Core Reading Materials in Grades K-2

ERIC Educational Resources Information Center

Foorman, Barbara R.; Herrera, Sarah; Dombek, Jennifer

2018-01-01

This randomized controlled trial in 55 low-performing schools across Florida compared 2 early literacy interventions--1 using stand-alone materials and 1 using materials embedded in the existing core reading/language arts program. A total of 3,447 students who were below the 30th percentile in vocabulary and reading-related skills participated in…

Improving the Reading of Bisyllabic Words That Involve Context-Sensitive Spelling Rules: Focus on Successes or on Failures?

ERIC Educational Resources Information Center

Steenbeek-Planting, Esther G.; van Bon, Wim H. J.; Schreuder, Robert

2013-01-01

The effect of two training procedures on the improvement of reading accuracy in poor readers was examined in relation to their initial reading level. A randomized controlled trial was conducted with 60 poor readers. Poor readers were assigned to a control group that received no training, or one of two training conditions. One training concentrated…

Examining the Average and Local Effects of a Standardized Treatment for Fourth Graders with Reading Difficulties

ERIC Educational Resources Information Center

Wanzek, Jeanne; Petscher, Yaacov; Al Otaiba, Stephanie; Kent, Shawn C.; Schatschneider, Christopher; Haynes, Martha; Rivas, Brenna K.; Jones, Francesca G.

2016-01-01

The present study used a randomized control trial to examine the effects of a widely used multicomponent Tier 2-type intervention, Passport to Literacy, on the reading ability of 221 fourth graders who initially scored at or below the 30th percentile in reading comprehension. Intervention was provided by research staff to groups of 4-7 students…

Examining the Average and Local Effects of a Standardized Treatment for Fourth Graders with Reading Difficulties

ERIC Educational Resources Information Center

Wanzek, Jeanne; Petscher, Yaacov; Al Otaiba, Stephanie; Kent, Shawn; Christopher, Schatschneider; Haynes, Martha; Rivas, Brenna K.; Jones, Francesca G.

2016-01-01

The present study used a randomized control trial to examine the effects of a widely-used multi-component Tier 2 type intervention, Passport to Literacy, on the reading ability of 221 fourth graders who initially scored at or below the 30th percentile in reading comprehension. Intervention was provided by research staff to groups of 4-7 students…

Impacts after One Year of "Healing Classroom" on Children's Reading and Math Skills in DRC: Results from a Cluster Randomized Trial

ERIC Educational Resources Information Center

Aber, J. Lawrence; Torrente, Catalina; Starkey, Leighann; Johnston, Brian; Seidman, Edward; Halpin, Peter; Shivshanker, Anjuli; Weisenhorn, Nina; Annan, Jeannie; Wolf, Sharon

2017-01-01

This article examines the effects of one year of exposure to "Learning to Read in a Healing Classroom" (LRHC) on the reading and math skills of second- to fourth-grade children in the low-income and conflict-affected Democratic Republic of the Congo. LRHC consists of two primary components: teacher resource materials that infuse…

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

PubMed Central

2010-01-01

Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031 PMID:20219120

The Impact of Achieve3000 on Elementary Literacy Outcomes: Randomized Control Trial Evidence, 2013-14 to 2014-15. Eye on Evaluation. DRA Report No. 16.02

ERIC Educational Resources Information Center

Hill, Darryl V.; Lenard, Matthew A.

2016-01-01

In 2013-14, the Wake County Public School System (WCPSS) launched Achieve3000 as a randomized controlled trial in 16 elementary schools. Achieve3000 is an early literacy program that differentiates non-fiction reading passages based on individual students' Lexile scores. Twoyear results show that Achieve3000 did not have a significant impact on…

An Examination of the Efficacy of a Multitiered Intervention on Early Reading Outcomes for First Grade Students at Risk for Reading Difficulties

ERIC Educational Resources Information Center

Fien, Hank; Smith, Jean Louise M.; Smolkowski, Keith; Baker, Scott K.; Nelson, Nancy J.; Chaparro, Erin

2015-01-01

This article presents findings of an efficacy trial examining the effect of a multitiered instruction and intervention model on first grade at-risk students' reading outcomes. Schools (N = 16) were randomly assigned to the treatment or control condition. In the fall of Grade 1, students were assigned to an instructional tier on the basis of…

Morpho-Phonemic Analysis Boosts Word Reading for Adult Struggling Readers

ERIC Educational Resources Information Center

Gray, Susan H.; Ehri, Linnea C.; Locke, John L.

2018-01-01

A randomized control trial compared the effects of two kinds of vocabulary instruction on component reading skills of adult struggling readers. Participants seeking alternative high school diplomas received 8 h of scripted tutoring to learn forty academic vocabulary words embedded within a civics curriculum. They were matched for language…

The Effects of ABRACADABRA on Reading Outcomes: A Meta-Analysis of Applied Field Research

ERIC Educational Resources Information Center

Abrami, Philip; Borohkovski, Eugene; Lysenko, Larysa

2015-01-01

This meta-analysis summarizes research on the effects of a comprehensive, interactive web-based software (AXXX) on the development of reading competencies among kindergarteners and elementary students. Findings from seven randomized control trials and quasi-experimental studies undertaken in a variety of contexts across Canada, Australia and Kenya…

Comparative Effectiveness of PCI Education's "PCI Reading Program": Phase 2--A Report of a Comparison Group Study in Brevard Public Schools and Miami-Dade County Public Schools. Research Summary

ERIC Educational Resources Information Center

Empirical Education Inc., 2010

2010-01-01

PCI Education sought scientifically based evidence on the comparative effectiveness of the "PCI Reading Program" through a five-year longitudinal study. Phase 1 of the study consisted of a randomized control trial studying the efficacy of the "PCI Reading Program-Level One" that was conducted in the 2007-2008 in Miami-Dade…

Effectiveness of Structured Teacher Adaptations to an Evidence-Based Summer Literacy Program

ERIC Educational Resources Information Center

Kim, James S.; Burkhauser, Mary A.; Quinn, David M.; Guryan, Jonathan; Kingston, Helen Chen; Aleman, Kirsten

2017-01-01

The authors conducted a cluster-randomized trial to examine the effectiveness of structured teacher adaptations to the implementation of an evidence-based summer literacy program that provided students with (a) books matched to their reading level and interests and (b) teacher scaffolding for summer reading in the form of end-of-year comprehension…

Literacy Coaching to Improve Student Reading Achievement: A Multi-Level Mediation Model

ERIC Educational Resources Information Center

Matsumura, Lindsay Clare; Garnier, Helen E.; Spybrook, Jessaca

2013-01-01

In a longitudinal group-randomized trial, we explore the key role of the quality of classroom text discussions in mediating the effects of Content-Focused Coaching (CFC) on student reading achievement (2983 students, 167 teachers). Schools in the United States serving large numbers of minority and English language learning (ELL) students from…

Differential Effects of Two Spelling Procedures on Acquisition, Maintenance and Adaption to Reading

ERIC Educational Resources Information Center

Cates, Gary L.; Dunne, Megan; Erkfritz, Karyn N.; Kivisto, Aaron; Lee, Nicole; Wierzbicki, Jennifer

2007-01-01

An alternating treatments design was used to assess the effects of a constant time delay (CTD) procedure and a cover-copy-compare (CCC) procedure on three students' acquisition, subsequent maintenance, and adaptation (i.e., application) of acquired spelling words to reading passages. Students were randomly presented two trials of word lists from…

Accelerating Preschoolers' Early Literacy Development through Classroom-Based Teacher-Child Storybook Reading and Explicit Print Referencing

ERIC Educational Resources Information Center

Justice, Laura M.; Kaderavek, Joan N.; Fan, Xitao; Sofka, Amy; Hunt, Aileen

2009-01-01

Purpose: This study examined the impact of teacher use of a print referencing style during classroom-based storybook reading sessions conducted over an academic year. Impacts on preschoolers' early literacy development were examined, focusing specifically on the domain of print knowledge. Method: This randomized, controlled trial examined the…

Successful Outcomes from a Structured Curriculum Used in the Veterans Affairs Low Vision Intervention Trial

ERIC Educational Resources Information Center

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…

Assessment Data-Informed Guidance to Individualize Kindergarten Reading Instruction: Findings from a Cluster-Randomized Control Field Trial

PubMed Central

Al Otaiba, Stephanie; Connor, Carol M; Folsom, Jessica Sidler; Greulich, Luana; Meadows, Jane; Li, Zhi

2010-01-01

The purpose of this cluster-randomized control field trial was to was to examine the extent to which kindergarten teachers could learn a promising instructional strategy, wherein kindergarten reading instruction was differentiated based upon students’ ongoing assessments of language and literacy skills and documented child characteristic by instruction (CXI) interactions; and to test the efficacy of this differentiated reading instruction on the reading outcomes of students from culturally diverse backgrounds. The study involved 14 schools and included 23 treatment (n = 305 students) and 21 contrast teacher (n = 251 students). Teachers in the contrast condition received only a baseline professional development that included a researcher-delivered summer day-long workshop on individualized instruction. Data sources included parent surveys, individually administered child assessments of language, cognitive, and reading skills and videotapes of classroom instruction. Using Hierarchical Multivariate Linear Modeling (HMLM), we found students in treatment classrooms outperformed students in the contrast classrooms on a latent measure of reading skills, comprised of letter-word reading, decoding, alphabetic knowledge, and phonological awareness (ES = .52). Teachers in both conditions provided small group instruction, but teachers in the treatment condition provided significantly more individualized instruction. Our findings extend research on the efficacy of teachers using Individualized Student Instruction to individualize instruction based upon students’ language and literacy skills in first through third grade. Findings are discussed regarding the value of professional development related to differentiating core reading instruction and the challenges of using Response to Intervention approaches to address students’ needs in the areas of reading in general education contexts. PMID:21818158

Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

PubMed Central

Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

2014-01-01

This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

Effects of Emergent Literacy Interventions for Preschoolers with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Hudson, Roxanne F.; Sanders, Elizabeth A.; Greenway, Rosanne; Xie, Sharon; Smith, Maya; Gasamis, Colin; Martini, Jay; Schwartz, Ilene; Hackett, Jacob

2017-01-01

Combining data from a series of three planned consecutive randomized controlled trials, the present study investigates two literacy interventions for preschool children with autism spectrum disorder. For the first cohort, children were randomized to interactive book reading (IBR; treatment) or business as usual (BAU; control); in Cohort 2,…

Efficacy of a Reading and Language Intervention for Children with Down Syndrome: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Burgoyne, Kelly; Duff, Fiona J.; Clarke, Paula J.; Buckley, Sue; Snowling, Margaret J.; Hulme, Charles

2012-01-01

Background: This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Methods: Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the…

Improving Reading Comprehension for High School Students with Disabilities: Effects for Comprehension and School Retention

ERIC Educational Resources Information Center

Vaughn, Sharon; Roberts, Greg; Schnakenberg, Jennifer B.; Fall, Anna-Mária; Vaughn, Michael G.; Wexler, Jade

2015-01-01

The authors examine the results for students with disabilities from a 2-year randomized controlled trial with students identified in ninth grade and followed through 10th grade in their allotted condition group. Prior to ninth grade, students with disabilities who met criteria for low reading comprehension (i.e., through failure on the state…

Multisyllabic Word-Reading Instruction with and without Motivational Beliefs Training for Struggling Readers in the Upper Elementary Grades: A Pilot Investigation

ERIC Educational Resources Information Center

Toste, Jessica R.; Capin, Philip; Vaughn, Sharon

2017-01-01

This randomized controlled trial focused on 59 struggling readers in the third and fourth grades (30 female, 29 male) and examined the efficacy of an intervention aimed at increasing students' multisyllabic word reading (MWR). The study also explored the relative effects of an embedded motivational beliefs (MB) training component. Struggling…

The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications.

PubMed

Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

2014-10-01

To assess the proportion of clinical trials explicitly reporting the risk of unblinding, to evaluate the completeness of reporting on unblinding risk, and to describe the reported procedures involved in assessing unblinding. We sampled at random 300 blinded randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8%), reported compromised blinding; and 8 publications, or 3% (95% CI, 1, 5%), intact blinding. The reporting on risk of unblinding in the 24 trial publications was generally incomplete. The median proportion of assessments per trial affected by unblinding was 3% (range 1-30%). The most common mechanism for unblinding was perceptible physical properties of the treatments, for example, a difference in the taste and odor of a typhoid vaccine compared with its placebo. Published articles on randomized clinical trials infrequently reported risk of unblinding. This may reflect a tendency for avoiding reporting actual or suspected unblinding or a genuine low risk of unblinding. Copyright © 2014 Elsevier Inc. All rights reserved.

Calcium/Vitamin D Supplementation and Coronary Artery Calcification

PubMed Central

Manson, JoAnn E.; Allison, Matthew A.; Carr, J. Jeffrey; Langer, Robert D.; Cochrane, Barbara B.; Hendrix, Susan L.; Hsia, Judith; Hunt, Julie R.; Lewis, Cora E.; Margolis, Karen L.; Robinson, Jennifer G.; Rodabough, Rebecca J.; Thomas, Asha M.

2010-01-01

Objectives Coronary artery calcified plaque is a marker for atheromatous plaque burden and predicts future risk of cardiovascular events. The relationship between calcium plus vitamin D supplementation and coronary artery calcium (CAC) has not been previously assessed in a randomized trial setting. We compared coronary artery calcium scores among women randomized to calcium/vitamin D supplementation versus placebo following trial completion. Methods In an ancillary substudy of women randomized to calcium carbonate (1000 mg of elemental calcium daily) plus vitamin D3 (400 IU daily) versus placebo, nested within the Women’s Health Initiative trial of estrogen among women with hysterectomy, we measured CAC with cardiac computed tomography in 754 women aged 50–59 years at randomization. Imaging for CAC was performed at 28 of 40 centers following a mean of 7 years of treatment and scans were read centrally. Coronary artery calcium scores were measured by a central reading center with masking to randomization assignments. Results Post-trial CAC measurements were similar in women randomized to calcium/vitamin D supplementation (calcium/D) and those receiving placebo. The mean CAC score was 91.6 for calcium/D and 100.5 for placebo (rank test p-value=0.74). After adjustment for coronary risk factors, multivariate odds ratios for increasing CAC score cutpoints (CAC >0, ≥10, and ≥100) for calcium/D vs placebo were 0.92 (95% confidence interval, 0.64–1.34), 1.29 (0.88–1.87), and 0.90 (0.56–1.44), respectively. Corresponding odds ratios among women with >50% adherence to study pills and for higher levels of CAC (>300), were similar. Conclusions Treatment with moderate doses of calcium plus vitamin D3 did not appear to alter coronary artery calcified plaque burden among postmenopausal women. PMID:20551849

Prospective, randomized, controlled trial using best-selling smoking-cessation book.

PubMed

Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

2017-07-01

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

Improving Struggling Readers' Early Literacy Skills through a Tier 2 Professional Development Program for Rural Classroom Teachers: The Targeted Reading Intervention

ERIC Educational Resources Information Center

Vernon-Feagans, Lynne; Bratsch-Hines, Mary; Varghese, Cheryl; Cutrer, Elizabeth A.; Garwood, Justin D.

2018-01-01

This article reports the results of a randomized controlled trial that replicated and extended research on the Targeted Reading Intervention (TRI), a professional development program for kindergarten and first-grade teachers in low-wealth rural schools that helps enhance literacy skills of struggling readers. In weekly webcam coaching sessions,…

Preparing Beginning Reading Teachers: An Experimental Comparison of Initial Early Literacy Field Experiences

ERIC Educational Resources Information Center

Al Otaiba, Stephanie; Lake, Vickie E.; Greulich, Luana; Folsom, Jessica S.; Guidry, Lisa

2012-01-01

This randomized-control trial examined the learning of preservice teachers taking an initial Early Literacy course in an early childhood education program and of the kindergarten or first grade students they tutored in their field experience. Preservice teachers were randomly assigned to one of two tutoring programs: Book Buddies and Tutor…

Effectiveness of Music Education for the Improvement of Reading Skills and Academic Achievement in Young Poor Readers: A Pragmatic Cluster-Randomized, Controlled Clinical Trial

PubMed Central

Cogo-Moreira, Hugo; de Ávila, Clara Regina Brandão; Ploubidis, George B.; Mari, Jair de Jesus

2013-01-01

Introduction Difficulties in word-level reading skills are prevalent in Brazilian schools and may deter children from gaining the knowledge obtained through reading and academic achievement. Music education has emerged as a potential method to improve reading skills because due to a common neurobiological substratum. Objective To evaluate the effectiveness of music education for the improvement of reading skills and academic achievement among children (eight to 10 years of age) with reading difficulties. Method 235 children with reading difficulties in 10 schools participated in a five-month, randomized clinical trial in cluster (RCT) in an impoverished zone within the city of São Paulo to test the effects of music education intervention while assessing reading skills and academic achievement during the school year. Five schools were chosen randomly to incorporate music classes (n = 114), and five served as controls (n = 121). Two different methods of analysis were used to evaluate the effectiveness of the intervention: The standard method was intention-to-treat (ITT), and the other was the Complier Average Causal Effect (CACE) estimation method, which took compliance status into account. Results The ITT analyses were not very promising; only one marginal effect existed for the rate of correct real words read per minute. Indeed, considering ITT, improvements were observed in the secondary outcomes (slope of Portuguese = 0.21 [p<0.001] and slope of math = 0.25 [p<0.001]). As for CACE estimation (i.e., complier children versus non-complier children), more promising effects were observed in terms of the rate of correct words read per minute [β = 13.98, p<0.001] and phonological awareness [β = 19.72, p<0.001] as well as secondary outcomes (academic achievement in Portuguese [β = 0.77, p<0.0001] and math [β = 0.49, p<0.001] throughout the school year). Conclusion The results may be seen as promising, but they are not, in themselves, enough to make music lessons as public policy. PMID:23544117

Effectiveness of music education for the improvement of reading skills and academic achievement in young poor readers: a pragmatic cluster-randomized, controlled clinical trial.

PubMed

Cogo-Moreira, Hugo; Brandão de Ávila, Clara Regina; Ploubidis, George B; Mari, Jair de Jesus

2013-01-01

Difficulties in word-level reading skills are prevalent in Brazilian schools and may deter children from gaining the knowledge obtained through reading and academic achievement. Music education has emerged as a potential method to improve reading skills because due to a common neurobiological substratum. To evaluate the effectiveness of music education for the improvement of reading skills and academic achievement among children (eight to 10 years of age) with reading difficulties. 235 children with reading difficulties in 10 schools participated in a five-month, randomized clinical trial in cluster (RCT) in an impoverished zone within the city of São Paulo to test the effects of music education intervention while assessing reading skills and academic achievement during the school year. Five schools were chosen randomly to incorporate music classes (n = 114), and five served as controls (n = 121). Two different methods of analysis were used to evaluate the effectiveness of the intervention: The standard method was intention-to-treat (ITT), and the other was the Complier Average Causal Effect (CACE) estimation method, which took compliance status into account. The ITT analyses were not very promising; only one marginal effect existed for the rate of correct real words read per minute. Indeed, considering ITT, improvements were observed in the secondary outcomes (slope of Portuguese = 0.21 [p<0.001] and slope of math = 0.25 [p<0.001]). As for CACE estimation (i.e., complier children versus non-complier children), more promising effects were observed in terms of the rate of correct words read per minute [β = 13.98, p<0.001] and phonological awareness [β = 19.72, p<0.001] as well as secondary outcomes (academic achievement in Portuguese [β = 0.77, p<0.0001] and math [β = 0.49, p<0.001] throughout the school year). The results may be seen as promising, but they are not, in themselves, enough to make music lessons as public policy.

Efficacy of a Word- and Text-Based Intervention for Students With Significant Reading Difficulties.

PubMed

Vaughn, Sharon; Roberts, Garrett J; Miciak, Jeremy; Taylor, Pat; Fletcher, Jack M

2018-05-01

We examine the efficacy of an intervention to improve word reading and reading comprehension in fourth- and fifth-grade students with significant reading problems. Using a randomized control trial design, we compare the fourth- and fifth-grade reading outcomes of students with severe reading difficulties who were provided a researcher-developed treatment with reading outcomes of students in a business-as-usual (BAU) comparison condition. A total of 280 fourth- and fifth-grade students were randomly assigned within school in a 1:1 ratio to either the BAU comparison condition ( n = 139) or the treatment condition ( n = 141). Treatment students were provided small-group tutoring for 30 to 45 minutes for an average of 68 lessons (mean hours of instruction = 44.4, SD = 11.2). Treatment students performed statistically significantly higher than BAU students on a word reading measure (effect size [ES] = 0. 58) and a measure of reading fluency (ES = 0.46). Though not statistically significant, effect sizes for students in the treatment condition were consistently higher than BAU students for decoding measures (ES = 0.06, 0.08), and mixed for comprehension (ES = -0.02, 0.14).

Reading Skill Transfer across Languages: Outcomes from Longitudinal Bilingual Randomized Control Trials in Kenya and Haiti

ERIC Educational Resources Information Center

Piper, Benjamin; Bulat, Jennae; Johnston, Andrew

2015-01-01

If children do not learn how to read in the first few years of primary school, they will struggle to complete the cycle, and are at greater risk of dropping out. It is therefore crucial to identify and test interventions that have the potential of making a large impact, can be implemented quickly, and are affordable to be taken to scale. This is…

Improving Congolese Children's Early Math and Reading Ability: Preliminary Results from a Cluster Randomized Trial in the Democratic Republic of the Congo

ERIC Educational Resources Information Center

Starkey, Leighann; Aber, J. Lawrence; Johnston, Brian M.

2014-01-01

Mastering basic numeracy and literacy skills is one of the most fundamental goals of education. However, it is estimated that 250 million primary-school-age children lack basic reading, writing and math skills (UN, 2013). Children living in war and poverty stricken countries are among the least likely to attain those basic goals. The United States…

A Randomized Trial of a Computer-Assisted Tutoring Program Targeting Letter-Sound Expression

ERIC Educational Resources Information Center

DuBois, Matthew R.; Volpe, Robert J.; Hemphill, Elizabeth M.

2014-01-01

Given that many schools have limited resources and a high proportion of students who present with deficits in early literacy skills, supports aimed at preventing reading failure must be simple and efficient and generate meaningful changes in student learning. We used a randomized group design with a wait-list control to extend the work of Volpe,…

Effectiveness of Supplemental Kindergarten Vocabulary Instruction for English Learners: A Randomized Study of Immediate and Longer-Term Effects of Two Approaches

ERIC Educational Resources Information Center

Vadasy, Patricia F.; Sanders, Elizabeth A.; Nelson, J. Ron

2015-01-01

A two-cohort cluster randomized trial was conducted to estimate effects of small-group supplemental vocabulary instruction for at-risk kindergarten English learners (ELs). "Connections" students received explicit instruction in high-frequency decodable root words, and interactive book reading (IBR) students were taught the same words in…

Reading and assessing reports of treatment studies in oncology.

PubMed

Simon, R

2000-04-01

Rapid advances in tumor biology, immunology, genomics, and technology give physicians great hopes for providing patients with better chances in the struggle against cancer. The pace of progress will be slowed, however, if we do not have clear answers regarding which treatments work and do not work. Such answers come from carefully designed, randomized, clinical trials. Such trials require infrastructure, commitment, cooperation, time, and money, and they provide little fame. They are, however, an invaluable contribution of the medical profession to their patients, to their next generation of colleagues, and to future patients. Randomized clinical trials that answer important medical questions definitively should be supported, participated in, and demanded by surgeons and oncologists.

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Melis-Dankers, Bart J M; van Rens, Ger H M B

2010-03-10

Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. http://www.trialregister.nl, identifier: NTR1031.

Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial.

PubMed

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

2010-01-01

This paper reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools (mean enrollment = 544) and was conducted from the 2002-03 through the 2005-06 academic years. Using school-level archival data, analyses comparing change from baseline (2002) to one-year post trial (2007) revealed that intervention schools scored 9.8% better on the TerraNova (2 nd ed.) test for reading and 8.8% on math; 20.7% better in Hawai'i Content and Performance Standards scores for reading and 51.4% better in math; and that intervention schools reported 15.2% lower absenteeism and fewer suspensions (72.6%) and retentions (72.7%). Overall, effect sizes were moderate to large (range 0.5-1.1) for all of the examined outcomes. Sensitivity analyses using permutation models and random-intercept growth curve models substantiated results. The results provide evidence that a comprehensive school-based program, specifically developed to target student behavior and character, can positively influence school-level achievement, attendance, and disciplinary outcomes concurrently.

Preparing beginning reading teachers: An experimental comparison of initial early literacy field experiences.

PubMed

Al Otaiba, Stephanie; Lake, Vickie E; Greulich, Luana; Folsom, Jessica S; Guidry, Lisa

2012-01-01

This randomized-control trial examined the learning of preservice teachers taking an initial Early Literacy course in an early childhood education program and of the kindergarten or first grade students they tutored in their field experience. Preservice teachers were randomly assigned to one of two tutoring programs: Book Buddies and Tutor Assisted Intensive Learning Strategies (TAILS), which provided identical meaning-focused instruction (shared book reading), but differed in the presentation of code-focused skills. TAILS used explicit, scripted lessons, and the Book Buddies required that code-focused instruction take place during shared book reading. Our research goal was to understand which tutoring program would be most effective in improving knowledge about reading, lead to broad and deep language and preparedness of the novice preservice teachers, and yield the most successful student reading outcomes. Findings indicate that all pre-service teachers demonstrated similar gains in knowledge, but preservice teachers in the TAILS program demonstrated broader and deeper application of knowledge and higher self-ratings of preparedness to teach reading. Students in both conditions made similar comprehension gains, but students tutored with TAILS showed significantly stronger decoding gains.

The effects of teacher read-alouds and student silent reading on predominantly bilingual high school seniors’ learning and retention of social studies content

PubMed Central

Reed, Deborah K.; Swanson, Elizabeth; Petscher, Yaacov; Vaughn, Sharon

2015-01-01

Teacher read-alouds (TRA) are common in middle and high school content area classes. Because the practice of reading the textbook out loud to students is often used out of concern about students’ ability to understand and learn from text when reading silently (SR), this randomized controlled trial was designed to experimentally manipulate text reading while blocking on all other instructional elements to determine the relative effects on learning content. Predominantly Spanish–English bilingual twelfth-graders (n = 123) were randomly assigned to either a TRA or SR condition and provided 1 week of high quality instruction in US history. Daily lessons included teaching key terms in the passage, previewing text headings, and conducting comprehension checks. Results of immediate, 1-week delayed, and 1-month delayed assessments of content learning revealed no significant differences between the two groups. Students were also asked to rate the method of reading they believed best helped them understand and remember information. Students in the SR condition more consistently agreed that reading silently was beneficial. Findings suggest low performing adolescents of different linguistic backgrounds can learn content as well when reading appropriately challenging text silently as when the teacher reads the text aloud to them. PMID:26346215

Omega 3/6 fatty acids for reading in children: a randomized, double-blind, placebo-controlled trial in 9-year-old mainstream schoolchildren in Sweden.

PubMed

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

2017-01-01

Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active treatment for all subjects. Mainstream schoolchildren aged 9-10 years were randomized 1:1 to receive three Omega 3/6 capsules twice daily or identical placebo. Assessments were made at baseline, 3 months, and 6 months. The primary outcome measure was the Logos test battery for evaluating reading abilities. The trial is registered with ClinicalTrials.gov, number NCT02557477. The study enrolled 154 children (active n = 78; placebo n = 76), of whom 122 completed the first 3 months (active n = 64; placebo n = 58) and 105 completed the whole study (active/active n = 55; placebo/active n = 50). Outcomes were assessed by per protocol (PP) and intention-to-treat (ITT) analyses. Active treatment was superior to placebo at 3 months for improvement in phonologic decoding time (PP active/placebo difference -0.16; 95% CI -0.03, -0.29; effect size (ES) .44; p = .005; and ITT ES .37; p = .036), in visual analysis time (PP active/placebo difference -0.19; 95% CI -0.05, -0.33; ES .49; p = .013; and ITT ES .40; p = .01), and for boys in phonologic decoding time (PP -0.22; 95% CI -0.03, -0.41; ES .62; p = .004). Children with ADHD-RS scores above the median showed treatment benefits in visual analysis time (PP ES .8, p = .009), reading speed per word (PP ES .61, p = .008), and phonologic decoding time per word (PP ES .85, p = .006). Adverse events were rare and mild, mainly stomach pain/diarrhea (active n = 9, placebo n = 2). Compared with placebo, 3 months of Omega 3/6 treatment improved reading ability - specifically the clinically relevant 'phonologic decoding time' and 'visual analysis time' - in mainstream schoolchildren. In particular, children with attention problems showed treatment benefits. © 2016 Association for Child and Adolescent Mental Health.

Tailored Behavioral Intervention for Insomnia in Children with Autism Spectrum Disorder

DTIC Science & Technology

2015-09-01

children with attention deficit/hyperactivity disorder. Journal of Physical Therapy Science, 24, 1-6. 15 9. Quietly Reading a Book Reading is a common...Journal of Occupational Therapy . 63(4):423-432. Silva, L., Schalock, M., Gabrielsen, K. (20 II). Early intervention for autism with a parent- delivered...Qigong massage program: A randomized controlled trial. American Journal of Occupational Therapy , 65(5):550-559. doi: 10.5014/ajoty.2011.000661. 9 4

The Impacts of a Scalable Intervention on the Language and Literacy Development of Rural Pre-Kindergartners

ERIC Educational Resources Information Center

Mashburn, Andrew; Justice, Laura M.; McGinty, Anita; Slocum, Laura

2016-01-01

Read It Again (RIA) is a curriculum for pre-kindergarten (pre-K) classrooms that targets children's development of language and literacy skills. A cluster randomized trial was conducted in which 104 pre-K classrooms in the Appalachian region of the United States were randomly assigned to one of three study conditions: Control (n = 30), RIA only…

Effects of Tier 3 Intervention for Students With Persistent Reading Difficulties and Characteristics of Inadequate Responders.

PubMed

Denton, Carolyn A; Tolar, Tammy D; Fletcher, Jack M; Barth, Amy E; Vaughn, Sharon; Francis, David J

2013-08-01

This article describes a randomized controlled trial conducted to evaluate the effects of an intensive, individualized, Tier 3 reading intervention for second grade students who had previously experienced inadequate response to quality first grade classroom reading instruction (Tier 1) and supplemental small-group intervention (Tier 2). Also evaluated were cognitive characteristics of students with inadequate response to intensive Tier 3 intervention. Students were randomized to receive the research intervention ( N = 47) or the instruction and intervention typically provided in their schools ( N = 25). Results indicated that students who received the research intervention made significantly better growth than those who received typical school instruction on measures of word identification, phonemic decoding, and word reading fluency and on a measure of sentence- and paragraph-level reading comprehension. Treatment effects were smaller and not statistically significant on phonemic decoding efficiency, text reading fluency, and reading comprehension in extended text. Effect sizes for all outcomes except oral reading fluency met criteria for substantive importance; however, many of the students in the intervention continued to struggle. An evaluation of cognitive profiles of adequate and inadequate responders was consistent with a continuum of severity (as opposed to qualitative differences), showing greater language and reading impairment prior to the intervention in students who were inadequate responders.

Effects of Tier 3 Intervention for Students With Persistent Reading Difficulties and Characteristics of Inadequate Responders

PubMed Central

Denton, Carolyn A.; Tolar, Tammy D.; Fletcher, Jack M.; Barth, Amy E.; Vaughn, Sharon; Francis, David J.

2013-01-01

This article describes a randomized controlled trial conducted to evaluate the effects of an intensive, individualized, Tier 3 reading intervention for second grade students who had previously experienced inadequate response to quality first grade classroom reading instruction (Tier 1) and supplemental small-group intervention (Tier 2). Also evaluated were cognitive characteristics of students with inadequate response to intensive Tier 3 intervention. Students were randomized to receive the research intervention (N = 47) or the instruction and intervention typically provided in their schools (N = 25). Results indicated that students who received the research intervention made significantly better growth than those who received typical school instruction on measures of word identification, phonemic decoding, and word reading fluency and on a measure of sentence- and paragraph-level reading comprehension. Treatment effects were smaller and not statistically significant on phonemic decoding efficiency, text reading fluency, and reading comprehension in extended text. Effect sizes for all outcomes except oral reading fluency met criteria for substantive importance; however, many of the students in the intervention continued to struggle. An evaluation of cognitive profiles of adequate and inadequate responders was consistent with a continuum of severity (as opposed to qualitative differences), showing greater language and reading impairment prior to the intervention in students who were inadequate responders. PMID:25308995

Assessing the readability of ClinicalTrials.gov

PubMed Central

Wu, Danny TY; Hanauer, David A; Mei, Qiaozhu; Clark, Patricia M; An, Lawrence C; Proulx, Joshua; Zeng, Qing T; Vydiswaran, VG Vinod; Collins-Thompson, Kevyn

2016-01-01

Objective ClinicalTrials.gov serves critical functions of disseminating trial information to the public and helping the trials recruit participants. This study assessed the readability of trial descriptions at ClinicalTrials.gov using multiple quantitative measures. Materials and Methods The analysis included all 165 988 trials registered at ClinicalTrials.gov as of April 30, 2014. To obtain benchmarks, the authors also analyzed 2 other medical corpora: (1) all 955 Health Topics articles from MedlinePlus and (2) a random sample of 100 000 clinician notes retrieved from an electronic health records system intended for conveying internal communication among medical professionals. The authors characterized each of the corpora using 4 surface metrics, and then applied 5 different scoring algorithms to assess their readability. The authors hypothesized that clinician notes would be most difficult to read, followed by trial descriptions and MedlinePlus Health Topics articles. Results Trial descriptions have the longest average sentence length (26.1 words) across all corpora; 65% of their words used are not covered by a basic medical English dictionary. In comparison, average sentence length of MedlinePlus Health Topics articles is 61% shorter, vocabulary size is 95% smaller, and dictionary coverage is 46% higher. All 5 scoring algorithms consistently rated CliniclTrials.gov trial descriptions the most difficult corpus to read, even harder than clinician notes. On average, it requires 18 years of education to properly understand these trial descriptions according to the results generated by the readability assessment algorithms. Discussion and Conclusion Trial descriptions at CliniclTrials.gov are extremely difficult to read. Significant work is warranted to improve their readability in order to achieve CliniclTrials.gov’s goal of facilitating information dissemination and subject recruitment. PMID:26269536

Response: Reading between the lines of cancer screening trials: using modeling to understand the evidence.

PubMed

Etzioni, Ruth; Gulati, Roman

2013-04-01

In our article about limitations of basing screening policy on screening trials, we offered several examples of ways in which modeling, using data from large screening trials and population trends, provided insights that differed somewhat from those based only on empirical trial results. In this editorial, we take a step back and consider the general question of whether randomized screening trials provide the strongest evidence for clinical guidelines concerning population screening programs. We argue that randomized trials provide a process that is designed to protect against certain biases but that this process does not guarantee that inferences based on empirical results from screening trials will be unbiased. Appropriate quantitative methods are key to obtaining unbiased inferences from screening trials. We highlight several studies in the statistical literature demonstrating that conventional survival analyses of screening trials can be misleading and list a number of key questions concerning screening harms and benefits that cannot be answered without modeling. Although we acknowledge the centrality of screening trials in the policy process, we maintain that modeling constitutes a powerful tool for screening trial interpretation and screening policy development.

Effect of the Sonas Programme on Communication in People with Dementia: A Randomized Controlled Trial

PubMed Central

Strøm, Benedicte Sørensen; Engedal, Knut; Benth, Jurate Saltyte; Grov, Ellen-Karine

2017-01-01

Background Strategies to improve communication in people with dementia are warranted. We examined the effect of the Sonas programme on communication ability in persons with moderate to severe dementia. Methods A 24-week 3-armed (Sonas, reading, and control group) randomized controlled trial including 120 nursing home residents with dementia was conducted; 105 completed the follow-up assessments. The main outcome was change in communication abilities measured by the Holden Communication Scale (HCS). Results We found no overall significant effect of the Sonas programme with regard to communication ability as measured by the HCS. However, an effect between the Sonas group and the reading group and between the Sonas group and the control group from T0 to T1 and T2 was found, as well as a significant improvement in communication in the Sonas group. Among people with severe dementia, the Sonas group scored significantly better on the HCS compared to the reading group after 12 weeks, but not after 24 weeks. Conclusion This study failed to document an overall effect of the Sonas programme on communication; however, the findings indicate that the Sonas programme has a significant effect on communication among those with severe dementia. PMID:28553314

An Empirical Investigation of Variance Design Parameters for Planning Cluster-Randomized Trials of Science Achievement.

PubMed

Westine, Carl D; Spybrook, Jessaca; Taylor, Joseph A

2013-12-01

Prior research has focused primarily on empirically estimating design parameters for cluster-randomized trials (CRTs) of mathematics and reading achievement. Little is known about how design parameters compare across other educational outcomes. This article presents empirical estimates of design parameters that can be used to appropriately power CRTs in science education and compares them to estimates using mathematics and reading. Estimates of intraclass correlations (ICCs) are computed for unconditional two-level (students in schools) and three-level (students in schools in districts) hierarchical linear models of science achievement. Relevant student- and school-level pretest and demographic covariates are then considered, and estimates of variance explained are computed. Subjects: Five consecutive years of Texas student-level data for Grades 5, 8, 10, and 11. Science, mathematics, and reading achievement raw scores as measured by the Texas Assessment of Knowledge and Skills. Results: Findings show that ICCs in science range from .172 to .196 across grades and are generally higher than comparable statistics in mathematics, .163-.172, and reading, .099-.156. When available, a 1-year lagged student-level science pretest explains the most variability in the outcome. The 1-year lagged school-level science pretest is the best alternative in the absence of a 1-year lagged student-level science pretest. Science educational researchers should utilize design parameters derived from science achievement outcomes. © The Author(s) 2014.

Using Randomized Clinical Trials to Determine the Impact of Reading Intervention on Struggling Adolescent Readers: Reports of Research from Five Nationally Funded Striving Readers Grants

ERIC Educational Resources Information Center

Loadman, William; Sprague, Kim; Hamilton, Jennifer; Coffey, Deb; Faddis, Bonnie

2010-01-01

In 2005, the U.S. Department of Education awarded eight Striving Readers grants to projects around the country. The goal of Striving Readers is to improve literacy skills and achievement for struggling readers in middle and high school and to increase the research base using randomized clinical research to address improvement in adolescent…

A Randomized Study of a Literacy-Integrated Science Intervention for Low-Socio-economic Status Middle School Students: Findings from first-year implementation

NASA Astrophysics Data System (ADS)

Tong, Fuhui; Irby, Beverly J.; Lara-Alecio, Rafael; Guerrero, Cindy; Fan, Yinan; Huerta, Margarita

2014-08-01

This paper presents the findings from a randomized control trial study of reading/literacy-integrated science inquiry intervention after 1 year of implementation and the treatment effect on 5th-grade low-socio-economic African-American and Hispanic students' achievement in science and English reading. A total of 94 treatment students and 194 comparison students from four randomized intermediate schools participated in the current project. The intervention consisted of ongoing professional development and specific instructional science lessons with inquiry-based learning, direct and explicit vocabulary instruction, and integration of reading and writing. Results suggested that (a) there was a significantly positive treatment effect as reflected in students' higher performance in district-wide curriculum-based tests of science and reading and standardized tests of science, reading, and English reading fluency; (b) males and females did not differ significantly from participating in science inquiry instruction; (c) African-American students had lower chance of sufficiently mastering the science concepts and achieving above the state standards when compared with Hispanic students across gender and condition, and (d) below-poverty African-American females are the most vulnerable group in science learning. Our study confirmed that even a modest amount of literacy integration in inquiry-based science instruction can promote students' science and reading achievement. Therefore, we call for more experimental research that focus on the quality of literacy-integrated science instruction from which middle grade students, particularly low-socio-economic status students, can benefit.

A cluster randomized control field trial of the ABRACADABRA web-based reading technology: replication and extension of basic findings

PubMed Central

Piquette, Noella A.; Savage, Robert S.; Abrami, Philip C.

2014-01-01

The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA), an evidence-based and web-based literacy intervention (http://abralite.concordia.ca) with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes) from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10–12 h of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d= +0.66), phonological blending (d = +0.52), and word reading (d = +0.52), over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years. PMID:25538663

Refractive versus diffractive multifocal intraocular lenses in cataract surgery: a meta-analysis of randomized controlled trials.

PubMed

Xu, Xian; Zhu, Ming-Ming; Zou, Hai-Dong

2014-09-01

Data sources, including PubMed, Medline, Embase, and the Cochrane Controlled Trials Register, were used to identify potentially relevant randomized controlled trials. Eight qualified studies incorporating 1,242 eyes of 621 patients were analyzed using Rev- Manager version 5.2 software (The Cochrane Collaboration, Oxford, England). The primary measures included uncorrected distance, intermediate, and near visual acuity. Reading ability, spectacle independence, and occurrence of photic phenomena were also addressed. The refractive MIOL group exhibited better uncorrected distance visual acuity than the diffractive MIOL group (weighted mean difference [WMD] = -0.04, 95% confidence interval [CI]: -0.06 to -0.02, P < .01). However, the diffractive MIOL group performed better than the refractive MIOL group in uncorrected near visual acuity, reading acuity, reading speed, smallest print size, spectacle independence, halo, and glare rate (WMD = 0.13, 95% CI: 0.10 to 0.17, P < .01; WMD = 0.14, 95% CI: 0.08 to 0.19, P < .01; WMD = -24.14, 95% CI: -43.56 to -4.72, P = .01; WMD = 0.56, 95% CI: 0.43 to 0.69, P < .01; WMD = 0.56, 95% CI: 0.45 to 0.70, P < .01; WMD = 1.50, 95% CI: 1.16 to 1.93, P = .002; WMD = 1.39, 95% CI: 1.10 to 1.75, P = .006, respectively). There was no significant difference between the two groups in uncorrected intermediate visual acuity (WMD = -0.04, 95% CI: -0.09 to 0.00, P = .05). Refractive MIOLs can provide better distance vision, whereas diffractive MIOLs provide better near vision, reading ability, and equivalent intermediate vision, reduce unwanted photic phenomena, and allow greater spectacle independence.

Beneficial effects of reading aloud and solving simple arithmetic calculations (learning therapy) on a wide range of cognitive functions in the healthy elderly: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Almost all cognitive functions decline with age. Results of previous studies have shown that cognitive training related to everyday life (reading aloud and solving simple arithmetic calculations), namely learning therapy, can improve two cognitive function (executive functions and processing speed) in elderly people. However, it remains unclear whether learning therapy engenders improvement of various cognitive functions or not. We investigate the impact of learning therapy on various cognitive functions (executive functions, episodic memory, short-term memory, working memory, attention, reading ability, and processing speed) in healthy older adults. Methods We use a single-blinded intervention with two parallel groups (a learning therapy group and a waiting list control group). Testers are blind to the study hypothesis and the group membership of participants. Through an advertisement in local newspaper, 64 healthy older adults are recruited. They will be assigned randomly to a learning therapy group or a waiting list control group. In the learning therapy group, participants are required to perform two cognitive tasks for 6 months: reading Japanese aloud and solving simple calculations. The waiting list group does not participate in the intervention. The primary outcome measure is the Stroop test score: a measure of executive function. Secondary outcome measures are assessments including the following: verbal fluency task, logical memory, first and second names, digit span forward, digit span backward, Japanese reading test, digit cancellation task, digit symbol coding, and symbol search. We assess these outcome measures before and after the intervention. Discussion This report is the first study which investigates the beneficial effects of learning therapy on a wide range of cognitive functions of elderly people. Our study provides sufficient evidence of learning therapy effectiveness. Most cognitive functions, which are correlated strongly with daily life activities, decrease with age. These study results can elucidate effects of cognitive training on elderly people. Trial registration This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000006998). PMID:22483196

Solution-Focused Brief Therapy: Impacts on Academic and Emotional Difficulties

ERIC Educational Resources Information Center

Daki, Julia; Savage, Robert S.

2010-01-01

This randomized control trial study evaluated the effectiveness of the solution-focused approach in addressing academic, motivational, and socioemotional needs of 14 children with reading difficulties. The intervention group received five 40-min solution-focused sessions. The control group received academic homework support. Results showed…

Calcium/vitamin D supplementation and coronary artery calcification in the Women's Health Initiative.

PubMed

Manson, JoAnn E; Allison, Matthew A; Carr, J Jeffrey; Langer, Robert D; Cochrane, Barbara B; Hendrix, Susan L; Hsia, Judith; Hunt, Julie R; Lewis, Cora E; Margolis, Karen L; Robinson, Jennifer G; Rodabough, Rebecca J; Thomas, Asha M

2010-07-01

Coronary artery calcified plaque is a marker for atheromatous plaque burden and predicts future risk of cardiovascular events. The relationship between calcium plus vitamin D (calcium/D) supplementation and coronary artery calcium (CAC) has not been previously assessed in a randomized trial setting. We compared CAC scores after trial completion between women randomized to calcium/vitamin D supplementation and women randomized to placebo. In an ancillary substudy of women randomized to calcium carbonate (1,000 mg of elemental calcium daily) plus vitamin D3 (400 IU daily) or placebo, nested within the Women's Health Initiative trial of estrogen among women who underwent hysterectomy, we measured CAC with cardiac CT in 754 women aged 50 to 59 years at randomization. Imaging for CAC was performed at 28 of 40 centers after a mean of 7 years of treatment, and scans were read centrally. CAC scores were measured by a central reading center with masking to randomization assignments. Posttrial CAC measurements were similar in women randomized to calcium/D supplementation and those receiving placebo. The mean CAC score was 91.6 for women receiving calcium/D and 100.5 for women receiving placebo (rank test P value = 0.74). After adjustment for coronary risk factors, multivariate odds ratios for increasing CAC score cutpoints (CAC >0, > or =10, and > or =100) for calcium/D versus placebo were 0.92 (95% CI, 0.64-1.34), 1.29 (0.88-1.87), and 0.90 (0.56-1.44), respectively. Corresponding odds ratios among women with a 50% or higher adherence to study pills and for higher levels of CAC (>300) were similar. Treatment with moderate doses of calcium plus vitamin D3 did not seem to alter coronary artery calcified plaque burden among postmenopausal women. Whether higher or lower doses would affect this outcome remains uncertain.

Assessing the readability of ClinicalTrials.gov.

PubMed

Wu, Danny T Y; Hanauer, David A; Mei, Qiaozhu; Clark, Patricia M; An, Lawrence C; Proulx, Joshua; Zeng, Qing T; Vydiswaran, V G Vinod; Collins-Thompson, Kevyn; Zheng, Kai

2016-03-01

ClinicalTrials.gov serves critical functions of disseminating trial information to the public and helping the trials recruit participants. This study assessed the readability of trial descriptions at ClinicalTrials.gov using multiple quantitative measures. The analysis included all 165,988 trials registered at ClinicalTrials.gov as of April 30, 2014. To obtain benchmarks, the authors also analyzed 2 other medical corpora: (1) all 955 Health Topics articles from MedlinePlus and (2) a random sample of 100,000 clinician notes retrieved from an electronic health records system intended for conveying internal communication among medical professionals. The authors characterized each of the corpora using 4 surface metrics, and then applied 5 different scoring algorithms to assess their readability. The authors hypothesized that clinician notes would be most difficult to read, followed by trial descriptions and MedlinePlus Health Topics articles. Trial descriptions have the longest average sentence length (26.1 words) across all corpora; 65% of their words used are not covered by a basic medical English dictionary. In comparison, average sentence length of MedlinePlus Health Topics articles is 61% shorter, vocabulary size is 95% smaller, and dictionary coverage is 46% higher. All 5 scoring algorithms consistently rated CliniclTrials.gov trial descriptions the most difficult corpus to read, even harder than clinician notes. On average, it requires 18 years of education to properly understand these trial descriptions according to the results generated by the readability assessment algorithms. Trial descriptions at CliniclTrials.gov are extremely difficult to read. Significant work is warranted to improve their readability in order to achieve CliniclTrials.gov's goal of facilitating information dissemination and subject recruitment. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government employees and is in the public domain in the US.

Differences in Functional Outcomes for Adult Patients with Prosthodontically-Treated and -Untreated Shortened Dental Arches: A Systematic Review

PubMed Central

Khan, Saadika; Musekiwa, Alfred; Chikte, Usuf M. E.; Omar, Ridwaan

2014-01-01

This review examined differences in functional outcomes and patient satisfaction when shortened dental arches are left untreated compared to their restoration to complete arch lengths with different prosthodontic interventions. Methods A protocol was developed according to the criteria for a systematic review. All relevant databases were searched to identify appropriate clinical trials regardless of language or publication status. Predetermined eligibility criteria were applied, trial quality assessed and data extracted for each study. Relevant outcomes assessed were: functioning ability, patient satisfaction and harmful effects on oral structures. Results Searches yielded 101 articles: 81 from electronic databases and 20 from reference lists of retrieved articles (PEARLing searches). Sixty-nine citations were assessed for eligibility after removing 32 duplicate records. After reading titles and abstracts, a total of 41 records were excluded and the full-texts of the remaining 28 records were read. Only 21 records were included for the SR because 7 records were excluded after reading the full-text reports. These 21 records report the outcomes of four randomized controlled trials (RCTs) and one non-randomized clinical trial (CT) which were pre-specified and used for this review. No on-going studies were found and no eligible studies were excluded for failure to report the reviewer’s pre-specified outcomes. Outcomes were reported in the retrieved 21 articles. A narrative explanation of the pre-specified outcomes is reported for the 3 comparison groups (which were based on the different interventions used for the individual clinical trials). The shortened dental arch as a treatment option is encouraging in terms of functioning, patient satisfaction and cost-effectiveness. By using only high quality studies it was expected that the results would be more reliable when making conclusions and recommendations, but some of the included studies had to be downgraded due to methodological errors. PMID:24992473

Accelerating preschoolers' early literacy development through classroom-based teacher-child storybook reading and explicit print referencing.

PubMed

Justice, Laura M; Kaderavek, Joan N; Fan, Xitao; Sofka, Amy; Hunt, Aileen

2009-01-01

This study examined the impact of teacher use of a print referencing style during classroom-based storybook reading sessions conducted over an academic year. Impacts on preschoolers' early literacy development were examined, focusing specifically on the domain of print knowledge. This randomized, controlled trial examined the effects of a print referencing style on 106 preschool children attending 23 classrooms serving disadvantaged preschoolers. Following random assignment, teachers in 14 classrooms used a print referencing style during 120 large-group storybook reading sessions during a 30-week period. Teachers in 9 comparison classrooms read at the same frequency and with the same storybooks but used their normal style of reading. Children whose teachers used a print referencing style showed larger gains on 3 standardized measures of print knowledge: print concept knowledge, alphabet knowledge, and name writing, with medium-sized effects. The convergence of the present findings with those of previous efficacy studies indicates that print referencing intervention can be used confidently as an approach for facilitating print knowledge in preschool-age children. Speech-language pathologists can serve an important role in supporting preschool educators as they use this evidence-based technique with pupils in their classrooms.

Books and babies: clinical-based literacy programs.

PubMed

Fortman, Kristine K; Fisch, Robert O; Phinney, Margaret Y; Defor, Terese A

2003-01-01

The purpose of this study was to assess parental response to a clinic-based literacy program at a health maintenance organization. It was hypothesized that participation would be associated with increased literacy orientation by children. This randomized community trial took place at a Midwestern health maintenance organization. Six clinics were paired and randomly assigned to participate or not participate in Project Read. The main outcome variable was literacy orientation (book use). The target population was parents of children younger than 12 months (N = 165). After 6 months of participation, parents were surveyed by telephone. Seventy-five percent and 77% of the treatment and control groups, respectively, had positive literacy orientation; this difference was not significant. Persons receiving a videotape were more likely to have a positive literacy orientation (82.9% vs 69.2%; P <.05). The multivariate regression analyses also showed that receiving the free videotape was a significant intervention exposure. The members of the population in this study are reading to their children. Parents who receive a videotape on the importance of reading are likely to read more to their children.

Effects of a Supplemental Vocabulary Program on Word Knowledge and Passage Comprehension

ERIC Educational Resources Information Center

Apthorp, Helen; Randel, Bruce; Cherasaro, Trudy; Clark, Tedra; McKeown, Margaret; Beck, Isabel

2012-01-01

A cluster randomized trial estimated the effects of a supplemental vocabulary program, Elements of Reading[R]: vocabulary on student vocabulary and passage comprehension in moderate- to high-poverty elementary schools. Forty-four schools participated over a period spanning 2 consecutive school years. At baseline, 1,057 teachers and 16,471 students…

The Impact of Teachers' Commenting Strategies on Children's Vocabulary Growth

ERIC Educational Resources Information Center

Barnes, Erica M.; Dickinson, David K.

2017-01-01

We examined the relations between teachers' use of comments during book reading sessions in preschool classrooms and the vocabulary growth of children with low and moderately low language ability. Using data from a larger randomized controlled trial, we analyzed comments defined as utterances that give, explain, expand, or define. Comments were…

Efficacy of Language Intervention in the Early Years

ERIC Educational Resources Information Center

Fricke, Silke; Bowyer-Crane, Claudine; Haley, Allyson J.; Hulme, Charles; Snowling, Margaret J.

2013-01-01

Background: Oral language skills in the preschool and early school years are critical to educational success and provide the foundations for the later development of reading comprehension. Methods: In a randomized controlled trial, 180 children from 15 UK nursery schools ("n" = 12 from each setting; M[subscript age] = 4;0) were randomly…

Training Parents to Help Their Children Read: A Randomized Control Trial

ERIC Educational Resources Information Center

Sylva, Kathy; Scott, Stephen; Totsika, Vasiliki; Ereky-Stevens, Katharina; Crook, Carolyn

2008-01-01

Background: Low levels of literacy and high levels of behaviour problems in middle childhood often co-occur. These persistent difficulties pose a risk to academic and social development, leading to social exclusion in adulthood. Although parent-training programmes have been shown to be effective in enabling parents to support their children's…

Efficacy of Rich Vocabulary Instruction in Fourth- and Fifth-Grade Classrooms

ERIC Educational Resources Information Center

Vadasy, Patricia F.; Sanders, Elizabeth A.; Logan Herrera, Becky

2015-01-01

A multi-cohort cluster randomized trial was conducted to estimate effects of rich vocabulary classroom instruction on vocabulary and reading comprehension. A total of 1,232 fourth- and fifth-grade students from 61 classrooms in 24 schools completed the study. Students received instruction in 140 Tier Two vocabulary words featured in two…

Improving Middle-School Students' Knowledge and Comprehension in Social Studies: A Replication

ERIC Educational Resources Information Center

Vaughn, Sharon; Roberts, Greg; Swanson, Elizabeth A.; Wanzek, Jeanne; Fall, Anna-Mária; Stillman-Spisak, Stephanie J.

2015-01-01

This study aimed to replicate findings that demonstrated impact on students' reading comprehension and social studies content learning. Using a randomized control trial, intervention, and outcome measures, this study was replicated in 85 8th-grade social studies classes with 19 teachers. Teachers were provided professional development on…

Core journals that publish clinical trials of physical therapy interventions.

PubMed

Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R

2010-11-01

The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best available evidence on the effects of physical therapy interventions have to read more broadly than just physical therapy-specific journals. Readers of articles on physical therapy trials should be aware that high-quality trials are not necessarily published in journals with high impact factors.

It takes just one word to quash a SNARC.

PubMed

Fischer, Martin H; Shaki, Samuel; Cruise, Alexander

2009-01-01

Our directional reading habit seems to contribute to the widely reported association of small numbers with left space and larger numbers with right space (the spatial-numerical association of response codes, SNARC, effect). But how can this association be so flexible when reading habits are not? To address this question, we asked bilingual Russian-Hebrew readers to classify numbers by parity and alternated the number format from trial to trial between written words and Arabic digits. The number words were randomly printed in either Cyrillic or Hebrew script, thus inducing left-to-right or right-to-left reading, respectively. Classification performance indicated that the digits were spatially mapped when they followed a Russian word but not when they followed a Hebrew word. An auditory control experiment revealed left-to-right SNARC effects with different strengths in both languages. These results suggest that the SNARC effect reflects recent spatial experiences, cross-modal associations, and long-standing directional habits but not an attribute of the number concepts themselves.

Early elementary school intervention to reduce conduct problems: a randomized trial with Hispanic and non-Hispanic children.

PubMed

Barrera, Manuel; Biglan, Anthony; Taylor, Ted K; Gunn, Barbara K; Smolkowski, Keith; Black, Carol; Ary, Dennis V; Fowler, Rollen C

2002-06-01

Children's aggressive behavior and reading difficulties during early elementary school years are risk factors for adolescent problem behaviors such as delinquency, academic failure, and substance use. This study determined if a comprehensive intervention that was designed to address both of these risk factors could affect teacher, parent, and observer measures of internalizing and externalizing problems. European American (n = 116) and Hispanic (n = 168) children from 3 communities who were selected for aggressiveness or reading difficulties were randomly assigned to an intervention or no-intervention control condition. Intervention families received parent training, and their children received social behavior interventions and supplementary reading instruction over a 2-year period. At the end of intervention, playground observations showed that treated children displayed less negative social behavior than controls. At the end of a 1-year follow-up, treated children showed less teacher-rated internalizing and less parent-rated coercive and antisocial behavior than controls. The study's limitations and implications for prevention are discussed.

Reading intervention with a growth mindset approach improves children's skills.

PubMed

Andersen, Simon Calmar; Nielsen, Helena Skyt

2016-10-25

Laboratory experiments have shown that parents who believe their child's abilities are fixed engage with their child in unconstructive, performance-oriented ways. We show that children of parents with such "fixed mindsets" have lower reading skills, even after controlling for the child's previous abilities and the parents' socioeconomic status. In a large-scale randomized field trial (N classrooms = 72; N children = 1,587) conducted by public authorities, parents receiving a reading intervention were told about the malleability of their child's reading abilities and how to support their child by praising his/her effort rather than his/her performance. This low-cost intervention increased the reading and writing achievements of all participating children-not least immigrant children with non-Western backgrounds and children with low-educated mothers. As expected, effects were even bigger for parents who before the intervention had a fixed mindset.

Implementation Challenges for Tier One and Tier Two School-Based Programs for Early Adolescents

ERIC Educational Resources Information Center

LaRusso, Maria D.; Donovan, Suzanne; Snow, Catherine

2016-01-01

This mixed-method study examined the implementation and the challenges to implementation for participants in randomized controlled trials of two school-based programs for early adolescents: the Tier One Word Generation (WG) program, and the Tier Two Strategic Adolescent Reading Intervention (STARI). Levels of implementation for WG and STARI varied…

The Effect of Content-Focused Coaching on the Quality of Classroom Text Discussions

ERIC Educational Resources Information Center

Matsumura, Lindsay Clare; Garnier, Helen E.; Spybrook, Jessaca

2012-01-01

This study examines the effect of a comprehensive literacy-coaching program focused on enacting a discussion-based approach to reading comprehension instruction (content-focused coaching [CFC]) on the quality of classroom text discussions over 2 years. The study used a cluster-randomized trial in which schools were assigned to either CFC or…

Order of Verdict Consideration and Decision Rule Effects on Mock Jury Decision Making.

ERIC Educational Resources Information Center

Olaye, Imafidon M.

A study investigated the effects of order verdict consideration and decision rule on jury verdicts. After reading the summary of an actual trial, 240 mock jurors drawn from undergraduate communications classes were randomly assigned to six-member juries. Jury assignments were made under two verdict orders (ascending and descending order of…

Implementing Large-Scale Instructional Technology in Kenya: Changing Instructional Practice and Developing Accountability in a National Education System

ERIC Educational Resources Information Center

Piper, Benjamin; Oyanga, Arbogast; Mejia, Jessica; Pouezevara, Sarah

2017-01-01

Previous large-scale education technology interventions have shown only modest impacts on student achievement. Building on results from an earlier randomized controlled trial of three different applications of information and communication technologies (ICTs) on primary education in Kenya, the Tusome Early Grade Reading Activity developed the…

Beneficial effects of reading aloud and solving simple arithmetic calculations (learning therapy) on a wide range of cognitive functions in the healthy elderly: study protocol for a randomized controlled trial.

PubMed

Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Nozawa, Takayuki; Sekiguchi, Atsushi; Nouchi, Haruka; Kawashima, Ryuta

2012-04-06

Almost all cognitive functions decline with age. Results of previous studies have shown that cognitive training related to everyday life (reading aloud and solving simple arithmetic calculations), namely learning therapy, can improve two cognitive function (executive functions and processing speed) in elderly people. However, it remains unclear whether learning therapy engenders improvement of various cognitive functions or not. We investigate the impact of learning therapy on various cognitive functions (executive functions, episodic memory, short-term memory, working memory, attention, reading ability, and processing speed) in healthy older adults. We use a single-blinded intervention with two parallel groups (a learning therapy group and a waiting list control group). Testers are blind to the study hypothesis and the group membership of participants. Through an advertisement in local newspaper, 64 healthy older adults are recruited. They will be assigned randomly to a learning therapy group or a waiting list control group. In the learning therapy group, participants are required to perform two cognitive tasks for 6 months: reading Japanese aloud and solving simple calculations. The waiting list group does not participate in the intervention. The primary outcome measure is the Stroop test score: a measure of executive function. Secondary outcome measures are assessments including the following: verbal fluency task, logical memory, first and second names, digit span forward, digit span backward, Japanese reading test, digit cancellation task, digit symbol coding, and symbol search. We assess these outcome measures before and after the intervention. This report is the first study which investigates the beneficial effects of learning therapy on a wide range of cognitive functions of elderly people. Our study provides sufficient evidence of learning therapy effectiveness. Most cognitive functions, which are correlated strongly with daily life activities, decrease with age. These study results can elucidate effects of cognitive training on elderly people. This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000006998).

Development of a battery of functional tests for low vision.

PubMed

Dougherty, Bradley E; Martin, Scott R; Kelly, Corey B; Jones, Lisa A; Raasch, Thomas W; Bullimore, Mark A

2009-08-01

We describe the development and evaluation of a battery of tests of functional visual performance of everyday tasks intended to be suitable for assessment of low vision patients. The functional test battery comprises-Reading rate: reading aloud 20 unrelated words for each of four print sizes (8, 4, 2, & 1 M); Telephone book: finding a name and reading the telephone number; Medicine bottle label: reading the name and dosing; Utility bill: reading the due date and amount due; Cooking instructions: reading cooking time on a food package; Coin sorting: making a specified amount from coins placed on a table; Playing card recognition: identifying denomination and suit; and Face recognition: identifying expressions of printed, life-size faces at 1 and 3 m. All tests were timed except face and playing card recognition. Fourteen normally sighted and 24 low vision subjects were assessed with the functional test battery. Visual acuity, contrast sensitivity, and quality of life (National Eye Institute Visual Function Questionnaire 25 [NEI-VFQ 25]) were measured and the functional tests repeated. Subsequently, 23 low vision patients participated in a pilot randomized clinical trial with half receiving low vision rehabilitation and half a delayed intervention. The functional tests were administered at enrollment and 3 months later. Normally sighted subjects could perform all tasks but the proportion of trials performed correctly by the low vision subjects ranged from 35% for face recognition at 3 m, to 95% for the playing card identification. On average, low vision subjects performed three times slower than the normally sighted subjects. Timed tasks with a visual search component showed poorer repeatability. In the pilot clinical trial, low vision rehabilitation produced the greatest improvement for the medicine bottle and cooking instruction tasks. Performance of patients on these functional tests has been assessed. Some appear responsive to low vision rehabilitation.

Children With Medical Complexity: A Web-Based Multimedia Curriculum Assessing Pediatric Residents Across North America.

PubMed

Shah, Neha H; Bhansali, Priti; Barber, Aisha; Toner, Keri; Kahn, Michael; MacLean, Meaghan; Kadden, Micah; Sestokas, Jeffrey; Agrawal, Dewesh

No standardized curricula exist for training residents in the special needs of children with medical complexity. We assessed resident satisfaction, knowledge, and behavior after implementing a novel online curriculum composed of multimedia modules on care of children with medical complexity utilizing virtual simulation. We conducted a randomized controlled trial of residents across North America. A Web-based curriculum of 6 self-paced, interactive, multimedia modules was developed. Readings for each topic served as the control curriculum. Residents were randomized to 1 of 2 groups, each completing 3 modules and 3 sets of readings that were mutually exclusive. Outcomes included resident scores on satisfaction, knowledge-based assessments, and virtual simulation activities. Four hundred forty-two residents from 56 training programs enrolled in the curriculum, 229 of whom completed it and were included in the analysis. Subjects were more likely to report comfort with all topics if they reviewed modules compared to readings (P ≤ .01 for all 6 topics). Posttest knowledge scores were significantly higher than pretest scores overall (mean increase in score 17.7%; 95% confidence interval 16.0, 19.4), and the mean pre-post score increase for modules was significantly higher than readings (20.9% vs 15.4%, P < .001). Mean scores on the verbal handoff virtual simulation increased by 1.1 points (95% confidence interval 0.2, 2.0, P = .02). There were no significant differences found in pre-post performance for the device-related emergency virtual simulation. There was high satisfaction, significant knowledge acquisition, and specific behavior change after participating in this innovative online curriculum. This is the first multisite, randomized trial assessing satisfaction, knowledge impact, and behavior change in a virtually simulated environment with pediatric trainees. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Efficacy of Parenting Education Compared to the Standard Method in Improvement of Reading and Writing Disabilities in Children

PubMed Central

Karahmadi, Mojgan; Shakibayee, Fereshteh; Amirian, Hushang; Bagherian-Sararoudi, Reza; Maracy, Mohammad Reza

2014-01-01

Objective: The present study aimed to evaluate the effect of parenting education on improvement of reading and writing disabilities in children. Methods: A randomized controlled trial was done on primary school students with reading and writing disabilities and their mothers. The subjects were divided into three groups with 26 members in each group. The first group (mothers’ education group) received 6 one-hour new educational sessions. The second group (standard group) received 12-15 standard educational sessions for learning disability, and the third group (control group) which consisted of students with learning disability did not receive any treatments. Research instruments included reading and writing tests, and demographic questionnaire. The three groups were evaluated via pretest and posttests at baseline and after one and three months of educational interventions. Data were analyzed using the chi-square, t-test, and repeated measures multivariate analysis of variance (MANOVA). Results: The mean reading speed had the most progression in the mothers' education group. Comparison among reading speed, reading accuracy, and spelling scores has been statistically significant (F 2, 6 = 90.64;p < 0.001) but the mean of these scores has been insignificant among the three groups (F 2, 67 = 0.583;p > 0.05). The mean reading accuracy, mostly increased after 3-month interventions in the mothers group. The control group had the lowest mean reading accuracy scores. Conclusion: Parenting education in mothers had a positive effect on the treatment of children with reading and writing disabilities. Declaration of interest: None. Clinical Trial Registration-URL: http://www.irct.ir. Unique identifier: IRCT201101205653N1. PMID:24995030

A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2. Methods/Design SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55% to 85%, that is, the ‘burden of hypoxia and hyperoxia’ expressed in ‘%hours’. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age, magnetic resonance imaging at term, blood biomarkers at 6 and 64 hours after birth, and adverse events. Discussion Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants. It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia. Trial registration ClinicalTrial.gov, NCT01590316 PMID:23782447

A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial

PubMed Central

Koufopoulos, Justin T; Conner, Mark T; Gardner, Peter H

2016-01-01

Background Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. Objective Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. Methods This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an “online community” or “no online community” (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others’ posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). Results In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. Conclusions Joining an online community did not improve adherence to preventer medication for asthma patients. Without the encouragement of greater community support or more components to sustain engagement over time, the current findings do not support the use of an online community to improve adherence. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 29399269; http://www.isrctn.com/ISRCTN29399269/29399269 (Archived by WebCite at http://www.webcitation.org/6fUbEuVoT) PMID:27298211

WWC Quick Review of the Report "Financial Incentives and Student Achievement: Evidence from Randomized Trials"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2010

2010-01-01

This study examined the effect of financial incentives on student achievement. The study analyzed data on approximately 38,000 students from about 260 public schools in Chicago, Dallas, New York City, and Washington, DC. The study found no statistically significant effects on standardized math or reading outcomes in Chicago, New York City, or…

Bilateral reading performance of 4 multifocal intraocular lens models and a monofocal intraocular lens under bright lighting conditions.

PubMed

Rasp, Max; Bachernegg, Alexander; Seyeddain, Orang; Ruckhofer, Josef; Emesz, Martin; Stoiber, Josef; Grabner, Günther; Dexl, Alois K

2012-11-01

To compare changes in reading performance parameters after implantation of 4 multifocal intraocular lens (IOL) models and a monofocal IOL. Department of Ophthalmology, Paracelsus Medical University, Salzburg, Austria. Prospective randomized controlled clinical trial. Patients with bilateral cataract without additional ocular pathology were scheduled for bilateral implantation of Acri.Smart 48S monofocal, Acrysof Restor SN6AD3 apodized multifocal, AT LISA 366D diffractive multifocal, Tecnis ZMA00 diffractive multifocal, or Rezoom refractive multifocal IOLs. Bilateral corrected and uncorrected reading acuity, reading distance, mean and maximum reading speeds, and smallest log-scaled print size of a Radner reading chart were evaluated under bright lighting conditions (500 lux) using the Salzburg Reading Desk. Pupil size was not measured throughout the trial. The minimum follow-up was 12 months. The diffractive multifocal groups had significantly better uncorrected reading acuity and uncorrected smallest print size than the monofocal and refractive multifocal groups 1, 6, and 12 months postoperatively. The diffractive IOL groups had comparable uncorrected reading distance of approximately 32 cm, which was larger in the monofocal group (38.9 ± 8.4 cm) and refractive multifocal group (37.1 ± 7.3 cm) at the last visit. Patients with diffractive IOLs could read print sizes of approximately 0.74 to 0.87 mm, which was much better than in the monofocal and refractive multifocal groups. The diffractive AT LISA IOL provided the best reading speed values (mean and maximum, corrected and uncorrected). Multifocal IOLs with a diffractive component provided good reading performance that was significantly better than that obtained with a refractive multifocal or monofocal IOL. Drs. Grabner and Dexl were patent owners of the Salzburg Reading Desk technology (now owned by SRD-Vision, LLC). No other author has a financial or proprietary interest in any material or method mentioned. Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Voting for image scoring and assessment (VISA)--theory and application of a 2 + 1 reader algorithm to improve accuracy of imaging endpoints in clinical trials.

PubMed

Gottlieb, Klaus; Hussain, Fez

2015-02-19

Independent central reading or off-site reading of imaging endpoints is increasingly used in clinical trials. Clinician-reported outcomes, such as endoscopic disease activity scores, have been shown to be subject to bias and random error. Central reading attempts to limit bias and improve accuracy of the assessment, two factors that are critical to trial success. Whether one central reader is sufficient and how to best integrate the input of more than one central reader into one output measure, is currently not known.In this concept paper we develop the theoretical foundations of a reading algorithm that can achieve both objectives without jeopardizing operational efficiency We examine the role of expert versus competent reader, frame scoring of imaging as a classification task, and propose a voting algorithm (VISA: Voting for Image Scoring and Assessment) as the most appropriate solution which could also be used to operationally define imaging gold standards. We propose two image readers plus an optional third reader in cases of disagreement (2 + 1) for ordinary scoring tasks. We argue that it is critical in trials with endoscopically determined endpoints to include the score determined by the site reader, at least in endoscopy clinical trials. Juries with more than 3 readers could define a reference standard that would allow a transition from measuring reader agreement to measuring reader accuracy. We support VISA by applying concepts from engineering (triple-modular redundancy) and voting theory (Condorcet's jury theorem) and illustrate our points with examples from inflammatory bowel disease trials, specifically, the endoscopy component of the Mayo Clinic Score of ulcerative colitis disease activity. Detailed flow-diagrams (pseudo-code) are provided that can inform program design.The VISA "2 + 1" reading algorithm, based on voting, can translate individual reader scores into a final score in a fashion that is both mathematically sound (by avoiding averaging of ordinal data) and in a manner that is consistent with the scoring task at hand (based on decisions about the presence or absence of features, a subjective classification task). While the VISA 2 + 1 algorithm is currently being used in clinical trials, empirical data of its performance have not yet been reported.

A randomized trial comparing concise and standard consent forms in the START trial

PubMed Central

Touloumi, Giota; Walker, A. Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G.; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen

2017-01-01

Background Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. Methods We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). Results 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. Conclusions An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Trial registration Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12 PMID:28445471

Effective Classroom Instruction: Implications of Child Characteristics by Reading Instruction Interactions on First Graders’ Word Reading Achievement

PubMed Central

Morrison, Frederick J.; Schatschneider, Christopher; Toste, Jessica; Lundblom, Erin; Crowe, Elizabeth C; Fishman, Barry

2011-01-01

Too many children fail to learn how to read proficiently with serious consequences for their overall well-being and long term success in school. This may be because providing effective instruction is more complex than many of the current models of reading instruction portray; there are child characteristic by instruction (CXI) interactions. Here we present efficacy results for a randomized control field trial of the Individualizing Student Instruction (ISI) intervention, which relies on dynamic system forecasting intervention models to recommend amounts of reading instruction for each student, taking into account CXI interactions that consider his or her vocabulary and reading skills. The study, conducted in seven schools with 25 teachers and 396 first graders, revealed that students in the ISI intervention classrooms demonstrated significantly greater reading skill gains by spring than did students in control classrooms. Plus, they were more likely to receive differentiated reading instruction based on CXI interaction guided recommended amounts than were students in control classrooms. The precision with which students received the recommended amounts of each type of literacy instruction, the distance from recommendation, also predicted reading outcomes. PMID:22229058

The Impact of Dialogic Book-Sharing Training on Infant Language and Attention: A Randomized Controlled Trial in a Deprived South African Community

ERIC Educational Resources Information Center

Vally, Zahir; Murray, Lynne; Tomlinson, Mark; Cooper, Peter J.

2015-01-01

Background: Dialogic book-sharing is an interactive form of shared reading. It has been shown in high income countries (HICs) to be of significant benefit to child cognitive development. Evidence for such benefit in low and middle income countries (LMICs) is scarce, although a feasibility study of our own produced encouraging findings.…

A Randomized Controlled Trial of a Response-to-Intervention (RTI) Tier 2 Literacy Program: Leveled Literacy Intervention (LLI)

ERIC Educational Resources Information Center

Ransford-Kaldon, Carolyn; Flynt, E. Sutton; Ross, Cristin

2011-01-01

The purpose of this study was twofold: (1) to determine the efficacy of the Leveled Literacy Intervention program (LLI) in increasing reading achievement for K-2 students and (2) to examine LLI program implementation fidelity. This study evaluated LLI in two U.S. school districts and used a mixed-method design to address the following key research…

The Experience of a Randomized Clinical Trial of Closed-Circuit Television versus Eccentric Viewing Training for People with Age-Related Macular Degeneration

ERIC Educational Resources Information Center

Leat, Susan J.; Si, Francis Fengqin; Gold, Deborah; Pickering, Dawn; Gordon, Keith; Hodge, William

2017-01-01

Introduction: In addition to optical devices, closed-circuit televisions (CCTVs) and eccentric viewing training are both recognized interventions to improve reading performance in individuals with vision loss secondary to age-related macular degeneration. Both are relatively expensive, however, either in the cost of the device or in the amount of…

Multilingual Literacy Skill Development in Kenya: Results from Medium Scale Randomized Controlled Trials

ERIC Educational Resources Information Center

Piper, Benjamin

2016-01-01

If children do not learn how to read in the first few years of primary school, they at greater risk of dropping out. It is therefore crucial to identify and test interventions that have the potential of making a large impact, can be implemented quickly, and are affordable to be taken to scale by the Kenyan government. This paper presents the…

The Impact of Project GLAD on Students' Literacy and Science Learning: Year 1 Results from a Cluster-Randomized Trial of Sheltered Instruction

ERIC Educational Resources Information Center

Deussen, Theresa; Autio, Elizabeth; Roccograndi, Angela; Hanita, Makoto

2014-01-01

With the increased population of English learners (ELs), educators need programs that help students access academic content while learning to understand, speak, read, and write English (Tharp, Estrada, Dalteen, & Yamaguchi 2000; Echevarria, Short & Powers, 2006). ELs come into U.S. schools needing to learn the same grade-level content as…

Interactive Book Reading to Accelerate Word Learning by Kindergarten Children With Specific Language Impairment: Identifying an Adequate Intensity and Variation in Treatment Response.

PubMed

Storkel, Holly L; Voelmle, Krista; Fierro, Veronica; Flake, Kelsey; Fleming, Kandace K; Romine, Rebecca Swinburne

2017-01-01

This study sought to identify an adequate intensity of interactive book reading for new word learning by children with specific language impairment (SLI) and to examine variability in treatment response. An escalation design adapted from nontoxic drug trials (Hunsberger, Rubinstein, Dancey, & Korn, 2005) was used in this Phase I/II preliminary clinical trial. A total of 27 kindergarten children with SLI were randomized to 1 of 4 intensities of interactive book reading: 12, 24, 36, or 48 exposures. Word learning was monitored through a definition task and a naming task. An intensity response curve was examined to identify the adequate intensity. Correlations and classification accuracy were used to examine variation in response to treatment relative to pretreatment and early treatment measures. Response to treatment improved as intensity increased from 12 to 24 to 36 exposures, and then no further improvements were observed as intensity increased to 48 exposures. There was variability in treatment response: Children with poor phonological awareness, low vocabulary, and/or poor nonword repetition were less likely to respond to treatment. The adequate intensity for this version of interactive book reading was 36 exposures, but further development of the treatment is needed to increase the benefit for children with SLI.

Interactive Book Reading to Accelerate Word Learning by Kindergarten Children With Specific Language Impairment: Identifying an Adequate Intensity and Variation in Treatment Response

PubMed Central

Voelmle, Krista; Fierro, Veronica; Flake, Kelsey; Fleming, Kandace K.; Romine, Rebecca Swinburne

2017-01-01

Purpose This study sought to identify an adequate intensity of interactive book reading for new word learning by children with specific language impairment (SLI) and to examine variability in treatment response. Method An escalation design adapted from nontoxic drug trials (Hunsberger, Rubinstein, Dancey, & Korn, 2005) was used in this Phase I/II preliminary clinical trial. A total of 27 kindergarten children with SLI were randomized to 1 of 4 intensities of interactive book reading: 12, 24, 36, or 48 exposures. Word learning was monitored through a definition task and a naming task. An intensity response curve was examined to identify the adequate intensity. Correlations and classification accuracy were used to examine variation in response to treatment relative to pretreatment and early treatment measures. Results Response to treatment improved as intensity increased from 12 to 24 to 36 exposures, and then no further improvements were observed as intensity increased to 48 exposures. There was variability in treatment response: Children with poor phonological awareness, low vocabulary, and/or poor nonword repetition were less likely to respond to treatment. Conclusion The adequate intensity for this version of interactive book reading was 36 exposures, but further development of the treatment is needed to increase the benefit for children with SLI. PMID:28036410

Enhancing access to reports of randomized trials published world-wide – the contribution of EMBASE records to the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

PubMed Central

Lefebvre, Carol; Eisinga, Anne; McDonald, Steve; Paul, Nina

2008-01-01

Background Randomized trials are essential in assessing the effects of healthcare interventions and are a key component in systematic reviews of effectiveness. Searching for reports of randomized trials in databases is problematic due to the absence of appropriate indexing terms until the 1990s and inconsistent application of these indexing terms thereafter. Objectives The objectives of this study are to devise a search strategy for identifying reports of randomized trials in EMBASE which are not already indexed as trials in MEDLINE and to make these reports easily accessible by including them in the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, with the permission of Elsevier, the publishers of EMBASE. Methods A highly sensitive search strategy was designed for EMBASE based on free-text and thesaurus terms which occurred frequently in the titles, abstracts, EMTREE terms (or some combination of these) of reports of trials indexed in EMBASE. This search strategy was run against EMBASE from 1980 to 2005 (1974 to 2005 for four of the terms) and records retrieved by the search, which were not already indexed as randomized trials in MEDLINE, were downloaded from EMBASE, printed and read. An analysis of the language of publication was conducted for the reports of trials published in 2005 (the most recent year completed at the time of this study). Results Twenty-two search terms were used (including nine which were later rejected due to poor cumulative precision). More than a third of a million records were downloaded and scanned and approximately 80,000 reports of trials were identified which were not already indexed as randomized trials in MEDLINE. These are now easily identifiable in CENTRAL, in The Cochrane Library. Cumulative sensitivity ranged from 0.1% to 60% and cumulative precision ranged from 8% to 61%. The truncated term 'random$' identified 60% of the total number of reports of trials but only 35% of the more than 130,000 records retrieved by this term were reports of trials. The language analysis for the sample year 2005 indicated that of the 18,427 reports indexed as randomized trials in MEDLINE, 959 (5%) were in languages other than English. The EMBASE search identified an additional 658 reports in languages other than English, of which the highest number were in Chinese (320). Conclusion The results of the search to date have greatly increased access to reports of trials in EMBASE, especially in some languages other than English. The search strategy used was subjectively derived from a small 'gold standard' set of test records and was not validated in an independent test set. We intend to design an objectively-derived validated search strategy using logistic regression based on the frequency of occurrence of terms in the approximately 80,000 reports of randomized trials identified compared with the frequency of these terms across the entire EMBASE database. PMID:18826567

A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

PubMed

Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

2009-12-01

A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control.

Randomized trial of supplementary interviewing techniques to enhance recall of sexual partners in contact interviews.

PubMed

Brewer, Devon D; Potterat, John J; Muth, Stephen Q; Malone, Patricia Z; Montoya, Pamela; Green, David L; Rogers, Helen L; Cox, Patricia A

2005-03-01

People with multiple sex partners tend to forget a significant proportion when recalling them. Randomized trial of supplementary interviewing techniques during routine partner notification contact interviews for chlamydia, gonorrhea, and syphilis in Colorado Springs, CO. Cases with multiple sex partners in the last 3 months (n = 123) participated. Interviewers prompted nonspecifically and read back the list of elicited partners after cases recalled partners on their own. We then randomly assigned cases to receive 1 of 3 sets of recall cues: (1) an experimental set of cues consisting of locations where people meet partners, role relationships, network ties, and first letters of names; (2) another experimental set including common first names; and (3) control cues referring to individual characteristics (e.g., physical appearance). Nonspecific prompting and reading back the list each increased the number of additional partners elicited and located by 3% to 5% on average. On average, the combined location/role/letter/network cues elicited more additional partners (0.57) than did the first-name (0.29) and individual characteristics (0.28) cues. The location and first-name cues were the most effective in eliciting located partners. The supplementary techniques increased the number of new cases found by 12% and, importantly, identified branches of the sexual network that would not otherwise have been discovered. Elicitation of sex partners can be enhanced in contact interviews with simple interviewing techniques, resulting in improved network ascertainment and sexually transmitted disease case finding.

Evaluation of a Two-Phase Experimental Study of a Small Group ("MultiLit") Reading Intervention for Older Low-Progress Readers

ERIC Educational Resources Information Center

Buckingham, Jennifer; Beaman-Wheldall, Robyn; Wheldall, Kevin

2014-01-01

The study reported here examined the efficacy of a small group (Tier 2 in a three-tier Response to Intervention model) literacy intervention for older low-progress readers (in Years 3-6). This article focuses on the second phase of a two-phase, crossover randomized control trial involving 26 students. In Phase 1, the experimental group (E1)…

What Works Clearinghouse Quick Review of the Report "Exercise Improves Executive Function and Achievement and Alters Brain Activation in Overweight Children: A Randomized, Controlled Trial"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

The study examined whether exercise offered to sedentary, overweight children ages 7 to 11 improved executive function--defined as strategy execution when presented with a novel task--and academic performance in reading and math. The study authors analyzed data on about 170 students from Georgia who were recruited in five cohorts from 2003 to…

A Randomized Controlled Trial of an Early-intervention, Computer-Based Literacy Program to Boost Phonological Skills in 4- to 6-year-old Children

ERIC Educational Resources Information Center

O'Callaghan, Paul; McIvor, Aimee; McVeigh, Claire; Rushe, Teresa

2016-01-01

Background: Many school-based interventions are being delivered in the absence of evidence of effectiveness (Snowling & Hulme, 2011, "Br. J. Educ. Psychol., 81," 1). Aims: This study sought to address this oversight by evaluating the effectiveness of the commonly used the Lexia Reading Core5 intervention, with 4- to 6-year-old pupils…

Family nurse practitioner student perception of journal abstract usefulness in clinical decision making: a randomized controlled trial.

PubMed

Johnson, Heather L; Fontelo, Paul; Olsen, Cara H; Jones, Kenneth D; Gimbel, Ronald W

2013-11-01

To assess family nurse practitioner (FNP) student perception of research abstract usefulness in clinical decision making. A randomized controlled trial conducted in a simulated environment with graduate FNP students of the Graduate School of Nursing, Uniformed Services University of the Health Sciences. Given a clinical case study and modified MEDLINE search tool accessible via an iPad device, participants were asked to develop a treatment plan and complete a data collection form. The primary measure was perceived usefulness of the research abstracts in clinical decision making regarding a simulated obese patient seeking to prevent type 2 diabetes. Secondary measures related to participant demographics and accessibility and usefulness of full-text manuscripts. The majority of NP students identified readily available research abstracts as useful in shaping their clinical decision making. The presence or absence of full-text manuscripts associated with the abstracts did not appear to influence the perceived abstract usefulness. The majority of students with full-text manuscript access in the timed simulated clinical encounter read at least one paper, but cited insufficient time to read full-text as a constraint. Research abstracts at point of care may be valuable to FNPs if easily accessible and integrated into clinical workflow. ©2013 The Author(s) ©2013 American Association of Nurse Practitioners.

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

PubMed

Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.

Influence of automatic word reading on motor control.

PubMed

Gentilucci, M; Gangitano, M

1998-02-01

We investigated the possible influence of automatic word reading on processes of visuo-motor transformation. Six subjects were required to reach and grasp a rod on whose visible face the word 'long' or 'short' was printed. Word reading was not explicitly required. In order to induce subjects to visually analyse the object trial by trial, object position and size were randomly varied during the experimental session. The kinematics of the reaching component was affected by word presentation. Peak acceleration, peak velocity, and peak deceleration of arm were higher for the word 'long' with respect to the word 'short'. That is, during the initial movement phase subjects automatically associated the meaning of the word with the distance to be covered and activated a motor program for a farther and/or nearer object position. During the final movement phase, subjects modified the braking forces (deceleration) in order to correct the initial error. No effect of the words on the grasp component was observed. These results suggest a possible influence of cognitive functions on motor control and seem to contrast with the notion that the analyses executed in the ventral and dorsal cortical visual streams are different and independent.

Omitted data in randomized controlled trials for anxiety and depression: A systematic review of the inclusion of sexual orientation and gender identity.

PubMed

Heck, Nicholas C; Mirabito, Lucas A; LeMaire, Kelly; Livingston, Nicholas A; Flentje, Annesa

2017-01-01

The current study examined the frequency with which randomized controlled trials (RCTs) of behavioral and psychological interventions for anxiety and depression include data pertaining to participant sexual orientation and nonbinary gender identities. Using systematic review methodology, the databases PubMed and PsycINFO were searched to identify RCTs published in 2004, 2009, and 2014. Random selections of 400 articles per database per year (2,400 articles in total) were considered for inclusion in the review. Articles meeting inclusion criteria were read and coded by the research team to identify whether the trial reported data pertaining to participant sexual orientation and nonbinary gender identities. Additional trial characteristics were also identified and indexed in our database (e.g., sample size, funding source). Of the 232 articles meeting inclusion criteria, only 1 reported participants' sexual orientation, and zero articles included nonbinary gender identities. A total of 52,769 participants were represented in the trials, 93 of which were conducted in the United States, and 43 acknowledged the National Institutes of Health as a source of funding. Despite known mental health disparities on the basis of sexual orientation and nonbinary gender identification, researchers evaluating interventions for anxiety and depression are not reporting on these important demographic characteristics. Reporting practices must change to ensure that our interventions generalize to lesbian, gay, bisexual, and transgender persons. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A Family-Centered Rounds Checklist, Family Engagement, and Patient Safety: A Randomized Trial

PubMed Central

Jacobsohn, Gwen C.; Rajamanickam, Victoria P.; Carayon, Pascale; Kelly, Michelle M.; Wetterneck, Tosha B.; Rathouz, Paul J.; Brown, Roger L.

2017-01-01

BACKGROUND AND OBJECTIVES: Family-centered rounds (FCRs) have become standard of care, despite the limited evaluation of FCRs’ benefits or interventions to support high-quality FCR delivery. This work examines the impact of the FCR checklist intervention, a checklist and associated provider training, on performance of FCR elements, family engagement, and patient safety. METHODS: This cluster randomized trial involved 298 families. Two hospital services were randomized to use the checklist; 2 others delivered usual care. We evaluated the performance of 8 FCR checklist elements and family engagement from 673 pre- and postintervention FCR videos and assessed the safety climate with the Children’s Hospital Safety Climate Questionnaire. Random effects regression models were used to assess intervention impact. RESULTS: The intervention significantly increased the number of FCR checklist elements performed (β = 1.2, P < .001). Intervention rounds were significantly more likely to include asking the family (odds ratio [OR] = 2.43, P < .05) or health care team (OR = 4.28, P = .002) for questions and reading back orders (OR = 12.43, P < .001). Intervention families’ engagement and reports of safety climate were no different from usual care. However, performance of specific checklist elements was associated with changes in these outcomes. For example, order read-back was associated with significantly more family engagement. Asking families for questions was associated with significantly better ratings of staff’s communication openness and safety of handoffs and transitions. CONCLUSIONS: The performance of FCR checklist elements was enhanced by checklist implementation and associated with changes in family engagement and more positive perceptions of safety climate. Implementing the checklist improves delivery of FCRs, impacting quality and safety of care. PMID:28557720

Reducing obesity prejudice in medical education.

PubMed

Matharu, Kabir; Shapiro, Johanna F; Hammer, Rachel R; Kravitz, R L; Wilson, Machelle D; Fitzgerald, Faith T

2014-01-01

Healthcare worker attitudes toward obese individuals facilitate discrimination and contribute to poor health outcomes. Previous studies have demonstrated medical student bias toward obese individuals, but few have examined effects of the educational environment on these prejudicial beliefs. We sought to determine whether an innovative educational intervention (reading a play about obesity) could diminish obesity prejudice relative to a standard medical lecture. We conducted a randomized, controlled trial enrolling medical students (n = 129) from three universities. Students were assigned to play-reading or a standard lecture. Explicit attitudes and implicit bias toward obese individuals were assessed prior to intervention and after four months. At baseline, students demonstrated moderate explicit and implicit bias toward obese people despite high scores on empathy. Students randomized to the play-reading group had significantly decreased explicit fat bias (P = 0.01) at follow-up, while students in the lecture group showed increased endorsement of a prescriptive model of care at the expense of a patient-centered approach (P = 0.03). There was a significant increase in empathy for those in both the theater (P = 0.007) and lecture group (P = 0.02). The intervention had no significant effect on implicit bias or regard for obesity as a civil rights issue. Dramatic reading may be superior to traditional medical lectures for showcasing patient rights and preferences. The present study demonstrates for the first time that play-reading diminishes conscious obesity bias. Further research should determine whether nontraditional methods of instruction promote improved understanding of and care for obese patients.

Reading Aloud and Solving Simple Arithmetic Calculation Intervention (Learning Therapy) Improves Inhibition, Verbal Episodic Memory, Focus Attention and Processing Speed in Healthy Elderly People: Evidence from a Randomized Controlled Trial

PubMed Central

Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Nozawa, Takayuki; Sekiguchi, Atsushi; Kawashima, Ryuta

2016-01-01

Background: Previous reports have described that simple cognitive training using reading aloud and solving simple arithmetic calculations, so-called “learning therapy”, can improve executive functions and processing speed in the older adults. Nevertheless, it is not well-known whether learning therapy improve a wide range of cognitive functions or not. We investigated the beneficial effects of learning therapy on various cognitive functions in healthy older adults. Methods: We used a single-blinded intervention with two groups (learning therapy group: LT and waiting list control group: WL). Sixty-four elderly were randomly assigned to LT or WL. In LT, participants performed reading Japanese aloud and solving simple calculations training tasks for 6 months. WL did not participate in the intervention. We measured several cognitive functions before and after 6 months intervention periods. Results: Compared to WL, results revealed that LT improved inhibition performance in executive functions (Stroop: LT (Mean = 3.88) vs. WL (Mean = 1.22), adjusted p = 0.013 and reverse Stroop LT (Mean = 3.22) vs. WL (Mean = 1.59), adjusted p = 0.015), verbal episodic memory (Logical Memory (LM): LT (Mean = 4.59) vs. WL (Mean = 2.47), adjusted p = 0.015), focus attention (D-CAT: LT (Mean = 2.09) vs. WL (Mean = −0.59), adjusted p = 0.010) and processing speed compared to the WL control group (digit symbol coding: LT (Mean = 5.00) vs. WL (Mean = 1.13), adjusted p = 0.015 and Symbol Search (SS): LT (Mean = 3.47) vs. WL (Mean = 1.81), adjusted p = 0.014). Discussion: This randomized controlled trial (RCT) can be showed the benefit of LT on inhibition of executive functions, verbal episodic memory, focus attention and processing speed in healthy elderly people. Our results were discussed under overlapping hypothesis. PMID:27242481

Reading Aloud and Solving Simple Arithmetic Calculation Intervention (Learning Therapy) Improves Inhibition, Verbal Episodic Memory, Focus Attention and Processing Speed in Healthy Elderly People: Evidence from a Randomized Controlled Trial.

PubMed

Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Nozawa, Takayuki; Sekiguchi, Atsushi; Kawashima, Ryuta

2016-01-01

Previous reports have described that simple cognitive training using reading aloud and solving simple arithmetic calculations, so-called "learning therapy", can improve executive functions and processing speed in the older adults. Nevertheless, it is not well-known whether learning therapy improve a wide range of cognitive functions or not. We investigated the beneficial effects of learning therapy on various cognitive functions in healthy older adults. We used a single-blinded intervention with two groups (learning therapy group: LT and waiting list control group: WL). Sixty-four elderly were randomly assigned to LT or WL. In LT, participants performed reading Japanese aloud and solving simple calculations training tasks for 6 months. WL did not participate in the intervention. We measured several cognitive functions before and after 6 months intervention periods. Compared to WL, results revealed that LT improved inhibition performance in executive functions (Stroop: LT (Mean = 3.88) vs. WL (Mean = 1.22), adjusted p = 0.013 and reverse Stroop LT (Mean = 3.22) vs. WL (Mean = 1.59), adjusted p = 0.015), verbal episodic memory (Logical Memory (LM): LT (Mean = 4.59) vs. WL (Mean = 2.47), adjusted p = 0.015), focus attention (D-CAT: LT (Mean = 2.09) vs. WL (Mean = -0.59), adjusted p = 0.010) and processing speed compared to the WL control group (digit symbol coding: LT (Mean = 5.00) vs. WL (Mean = 1.13), adjusted p = 0.015 and Symbol Search (SS): LT (Mean = 3.47) vs. WL (Mean = 1.81), adjusted p = 0.014). This randomized controlled trial (RCT) can be showed the benefit of LT on inhibition of executive functions, verbal episodic memory, focus attention and processing speed in healthy elderly people. Our results were discussed under overlapping hypothesis.

A nephrology guide to reading and using systematic reviews of randomized trials.

PubMed

Badve, Sunil V; Palmer, Suetonia C; Johnson, David W; Strippoli, Giovanni F M

2015-06-01

Conscientious integration of the best available evidence in the care of an individual patient could be challenging for a busy clinician. A well-conducted systematic review can adequately inform not only the clinicians, but also the policy makers and researchers about the benefits and risks of a particular intervention. In this article, we describe how to critically appraise the methods and interpret the results of a systematic review of interventional trials and apply the findings of a systematic review to the clinical questions. © The Author 2014. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Feasibility, Acceptability and Findings from a Pilot Randomized Controlled Intervention Study on the Impact of a Book Designed to Inform Patients about Cancer Clinical Trials

PubMed Central

Carney, Patricia A.; Tucker, Erin K.; Newby, Timothy A.; Beer, Tomasz M.

2014-01-01

Objective To assess the feasibility, acceptability and changes in knowledge among cancer patients assigned to receive a 160 page book on experimental cancer therapies and clinical trials. Methods We enrolled 20 patients with cancer who had never participated in a clinical trial, and randomly assigned them to receive the book either during Week 1or Week 4 of the study. We collected baseline patient demographic and cancer related information as well as knowledge about cancer clinical trials at Week 0. Follow-up surveys were administered at Weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book Early (at Week 1) to those who received it Later (at Week 4). Results One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by Week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at Week 3 and 95.5% in the Late Group at Week 6). Within group pair-wise comparisons found significant difference between baseline and Week 6 in content-specific knowledge scores among participants in the Late Group (79% vs. 92.1%, p=0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Conclusions Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials. PMID:24127249

Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials.

PubMed

Carney, Patricia A; Tucker, Erin K; Newby, Timothy A; Beer, Tomasz M

2014-03-01

This study was conducted to assess the feasibility, acceptability, and changes in knowledge among cancer patients assigned to receive a 160-page book on experimental cancer therapies and clinical trials. We enrolled 20 patients with cancer who had never participated in a clinical trial and randomly assigned them to receive the book either during week 1 or week 4 of the study. We collected baseline patient demographic and cancer-related information as well as knowledge about cancer clinical trials at week 0. Follow-up surveys were administered at weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book early (at week 1) to those who received it later (at week 4). One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at week 3 and 95.5% in the Late Group at week 6). Within group pairwise comparisons found significant difference between baseline and week 6 in content-specific knowledge scores among participants in the Late Group [79% versus 92.1%, p = 0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials.

An Examination of the Efficacy of a Multitiered Intervention on Early Reading Outcomes for First Grade Students at Risk for Reading Difficulties.

PubMed

Fien, Hank; Smith, Jean Louise M; Smolkowski, Keith; Baker, Scott K; Nelson, Nancy J; Chaparro, Erin

2015-01-01

This article presents findings of an efficacy trial examining the effect of a multitiered instruction and intervention model on first grade at-risk students' reading outcomes. Schools (N = 16) were randomly assigned to the treatment or control condition. In the fall of Grade 1, students were assigned to an instructional tier on the basis of Stanford Achievement Test-10th Edition scores (31st percentile and above = Tier 1; from the 10th to the 30th percentile = Tier 2). In both conditions, students identified as at risk (i.e., Tier 2; n = 267) received 90 min of whole group instruction (Tier 1) and an additional 30 min of daily small group intervention (Tier 2). In the treatment condition, teachers were trained to enhance core reading instruction by making instruction more explicit and increasing practice opportunities for students in Tier 1. In addition, at-risk readers were provided an additional 30-min daily small group intervention with content that was highly aligned with the Tier 1 core reading program. Results indicate significant, positive effects of the intervention on students' decoding and first semester fluent reading and potentially positive effects on reading comprehension and total reading achievement. © Hammill Institute on Disabilities 2014.

Primary Care Strategies for Promoting Parent-Child Interactions and School Readiness in At-Risk Families

PubMed Central

Mendelsohn, Alan L.; Huberman, Harris S.; Berkule, Samantha B.; Brockmeyer, Carolyn A.; Morrow, Lesley M.; Dreyer, Benard P.

2011-01-01

Objective To determine the effects of pediatric primary care interventions on parent-child interactions in families with low socioeconomic status. Design In this randomized controlled trial, participants were randomized to 1 of 2 interventions (Video Interaction Project [VIP] or Building Blocks [BB]) or the control group. Setting Urban public hospital pediatric primary care clinic. Participants Mother-newborn dyads enrolled post partum from November 1, 2005, through October 31, 2008. Interventions In the VIP group, mothers and newborns participated in 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading by reviewing videos made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. In the BB group, parenting materials, including age-specific newsletters suggesting interactive activities, learning materials, and parent-completed developmental questionnaires, were mailed to the mothers. Main Outcome Measures Parent-child interactions were assessed at 6 months with the StimQ-Infant and a 24-hour shared reading recall diary. Results A total of 410 families were assessed. The VIP group had a higher increased StimQ score (mean difference, 3.6 points; 95% confidence interval, 1.5 to 5.6 points; Cohen d, 0.51; 0.22 to 0.81) and more reading activities compared to the control group. The BB group also had an increased overall StimQ score compared with the control group (Cohen d, 0.31; 95% confidence interval, 0.03 to 0.60). The greatest effects for the VIP group were found for mothers with a ninth-grade or higher reading level (Cohen d, 0.68; 95% confidence interval, 0.33 to 1.03). Conclusions The VIP and BB groups each led to increased parent-child interactions. Pediatric primary care represents a significant opportunity for enhancing developmental trajectories in at-risk children. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199978

Physically Active Math and Language Lessons Improve Academic Achievement: A Cluster Randomized Controlled Trial.

PubMed

Mullender-Wijnsma, Marijke J; Hartman, Esther; de Greeff, Johannes W; Doolaard, Simone; Bosker, Roel J; Visscher, Chris

2016-03-01

Using physical activity in the teaching of academic lessons is a new way of learning. The aim of this study was to investigate the effects of an innovative physically active academic intervention ("Fit & Vaardig op School" [F&V]) on academic achievement of children. Using physical activity to teach math and spelling lessons was studied in a cluster-randomized controlled trial. Participants were 499 children (mean age 8.1 years) from second- and third-grade classes of 12 elementary schools. At each school, a second- and third-grade class were randomly assigned to the intervention or control group. The intervention group participated in F&V lessons for 2 years, 22 weeks per year, 3 times a week. The control group participated in regular classroom lessons. Children's academic achievement was measured before the intervention started and after the first and second intervention years. Academic achievement was measured by 2 mathematics tests (speed and general math skills) and 2 language tests (reading and spelling). After 2 years, multilevel analysis showed that children in the intervention group had significantly greater gains in mathematics speed test (P < .001; effect size [ES] 0.51), general mathematics (P < .001; ES 0.42), and spelling (P < .001; ES 0.45) scores. This equates to 4 months more learning gains in comparison with the control group. No differences were found on the reading test. Physically active academic lessons significantly improved mathematics and spelling performance of elementary school children and are therefore a promising new way of teaching. Copyright © 2016 by the American Academy of Pediatrics.

Discourse level reading comprehension interventions following acquired brain injury: a systematic review.

PubMed

Watter, Kerrin; Copley, Anna; Finch, Emma

2017-02-01

Purpose Reading comprehension can change following acquired brain injury (ABI), impacting independence and participation. This review aims to identify and evaluate the interventions used for rehabilitation of discourse level reading in adults with ABI. Methods A systematic review was conducted of published journal articles. Methodological quality of studies was reviewed using formal and informal rating scales. Inclusion criteria involved adults with non-progressive ABI who experienced discourse level reading deficits related to aphasia or cognitive-communication disorders. Results A total of 23 studies were identified; these included randomized controlled trials, cohort and case studies. Six different types of reading interventions were found, overall results of these interventions were mixed. Reading deficits were reportedly related to language (aphasia) and/or cognitive deficits, with assessment processes varying. Questions arose regarding comparability of assessment methods and diagnostic issues across the studies. Conclusions Interventions for discourse level reading comprehension can make positive changes to reading function. However, no intervention was identified as a gold standard. A trend toward strategy-based reading was found, with these offering a potential for (comparatively) cost-effective lower-dosage reading treatments with positive-trend results. Cognitive and language features should be considered for assessment and intervention planning for discourse reading in ABI. Implications for Rehabilitation Six different types of discourse reading comprehension interventions for people with ABI were identified, with mixed evidence for each intervention. Clinicians need to consider both the linguistic and cognitive features of reading for assessment and intervention planning for discourse level reading. There is a research trend toward strategy-based reading interventions, which use a lower treatment dosage.

The Impact of Providing Vision Screening and Free Eyeglasses on Academic Outcomes: Evidence from a Randomized Trial in Title I Elementary Schools in Florida

PubMed Central

West, Kristine L.; Lee, Jongwook

2018-01-01

More than 20 percent of all school-aged children in the United States have vision problems, and low-income and minority children are disproportionately likely to have unmet vision care needs. Vision screening is common in U.S. schools, but it remains an open question whether screening alone is sufficient to improve student outcomes. We implemented a multi-armed randomized controlled trial to evaluate the impact of vision screening, and of vision screening accompanied by eye exams and eyeglasses, provided by a non-profit organization to Title I elementary schools in three large central Florida school districts. We find that providing additional/enhanced screening alone is generally insufficient to improve student achievement in math and reading. In contrast, providing screening along with free eye exams and free eyeglasses to students with vision problems improved student achievement as measured by standardized test scores. We find, averaging over all students (including those without vision problems), that this more comprehensive intervention increased the probability of passing the Florida Comprehensive Achievement Tests (FCAT) in reading and math by approximately 2.0 percentage points. We also present evidence that indicates that this impact fades out over time, indicating that follow-up actions after the intervention may be necessary to sustain these estimated achievement gains. PMID:29693366

A propaganda index for reviewing problem framing in articles and manuscripts: an exploratory study.

PubMed

Gambrill, Eileen; Reiman, Amanda

2011-01-01

To determine the effectiveness of an index in increasing recognition of misleading problem framing in articles and manuscripts. A propaganda index consisting of 32 items was developed drawing on related literature. Seventeen subjects who review manuscripts for possible publication were requested to read five recent published reports of randomized controlled trials concerning social anxiety and to identify indicators of propaganda (defined as encouraging beliefs and actions with the least thought possible). They then re-read the same five articles using a propaganda index to note instances of propaganda. Convenience sample of individuals who review manuscripts for possible publication and sample of recent published reports of randomized controlled trials regarding social anxiety in five different journals by different authors, blinded by author and journal. Data showed that there was a high rate of propagandistic problem framing in reports of RCTs regarding social anxiety such as hiding well argued alternative views and vagueness. This occurred in 117 out of 160 opportunities over five research reports. A convenience sample of 17 academics spotted only 4.5 percent of propaganda indicators. This increased to 64 percent with use of the 32 item propaganda index. Use of a propaganda index increased recognition of related indicators. However many instances remained undetected. This propaganda index warrants further exploration as a complement to reporting guidelines such as CONSORT and PRISMA.

Influence of Methylphenidate on the Frequency of Stuttering: A Randomized Controlled Trial.

PubMed

Rabaeys, Henk; Bijleveld, Henny-Annie; Devroey, Dirk

2015-10-01

Recently, a case report described a decrease in frequency of stuttering after intake of methylphenidate (MPH). This study was undertaken to investigate if this effect could again be reproduced in a population of young healthy male adult persons with developmental stuttering. A double-blind randomized crossover trial, with a 2-week washout period, including 15 Dutch-speaking young healthy persons with developmental stuttering, assessed the effects of a single dose of 20 mg MPH compared with placebo on stuttering. Dependent and 1-sample t tests were used to detect significant differences. The end point was the number of stutter moments and self-perceived improvement. MPH yielded a significant decrease in the number of stutter moments when reading and speaking (P = 0.002), which was not the case with placebo (P = 0.090). There was a significant improvement from baseline after intake of MPH as compared with placebo (P = 0.003). Self-perceived improvement with MPH was not significantly better as compared with placebo (P = 0.28). This study showed that the participants had an objective statistically significant decrease in the frequency of stuttering with MPH, and this was not the case with placebo. This was also the case for a reduction in stutter moments when reading out loud and speaking spontaneously. However, this result was not subjectively perceived by the participants. © The Author(s) 2015.

A Propaganda Index for Reviewing Problem Framing in Articles and Manuscripts: An Exploratory Study

PubMed Central

Gambrill, Eileen; Reiman, Amanda

2011-01-01

Objective To determine the effectiveness of an index in increasing recognition of misleading problem framing in articles and manuscripts. Design A propaganda index consisting of 32 items was developed drawing on related literature. Seventeen subjects who review manuscripts for possible publication were requested to read five recent published reports of randomized controlled trials concerning social anxiety and to identify indicators of propaganda (defined as encouraging beliefs and actions with the least thought possible). They then re-read the same five articles using a propaganda index to note instances of propaganda. Data source Convenience sample of individuals who review manuscripts for possible publication and sample of recent published reports of randomized controlled trials regarding social anxiety in five different journals by different authors, blinded by author and journal. Results Data showed that there was a high rate of propagandistic problem framing in reports of RCTs regarding social anxiety such as hiding well argued alternative views and vagueness. This occurred in 117 out of 160 opportunities over five research reports. A convenience sample of 17 academics spotted only 4.5 percent of propaganda indicators. This increased to 64 percent with use of the 32 item propaganda index. Use of a propaganda index increased recognition of related indicators. However many instances remained undetected. Conclusion This propaganda index warrants further exploration as a complement to reporting guidelines such as CONSORT and PRISMA. PMID:21647426

Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab

PubMed Central

Ahmad, Harris; Berzin, Tyler M.; Yu, Hui Jing; Huang, Christopher S.; Mishkin, Daniel S.

2014-01-01

Clinical trials in inflammatory bowel disease (IBD) are evolving at a rapid pace by employing central reading for endoscopic mucosal assessment in a field that was, historically, largely based on assessments by local physicians. This transition from local to central reading carries with it numerous technical, operational, and scientific challenges, many of which can be resolved by imaging core laboratories (ICLs), a concept that has a longer history in clinical trials in a number of diseases outside the realm of gastroenterology. For IBD trials, ICLs have the dual goals of providing objective, consistent assessments of endoscopic findings using central-reading paradigms whilst providing important expertise with regard to operational issues and regulatory expectations. This review focuses on current approaches to using ICLs for central endoscopic reading in IBD trials. PMID:24994835

Efficacy of a reading and language intervention for children with Down syndrome: a randomized controlled trial

PubMed Central

Burgoyne, Kelly; Duff, Fiona J; Clarke, Paula J; Buckley, Sue; Snowling, Margaret J; Hulme, Charles

2012-01-01

Background This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Methods Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the intervention immediately, whereas the remaining children received the treatment after a 20-week delay. Fifty-seven children with Down syndrome in mainstream primary schools in two UK locations (Yorkshire and Hampshire) were randomly allocated to intervention (40 weeks of intervention) and waiting control (20 weeks of intervention) groups. Assessments were conducted at three time points: pre-intervention, after 20 weeks of intervention, and after 40 weeks of intervention. Results After 20 weeks of intervention, the intervention group showed significantly greater progress than the waiting control group on measures of single word reading, letter-sound knowledge, phoneme blending and taught expressive vocabulary. Effects did not transfer to other skills (nonword reading, spelling, standardised expressive and receptive vocabulary, expressive information and grammar). After 40 weeks of intervention, the intervention group remained numerically ahead of the control group on most key outcome measures; but these differences were not significant. Children who were younger, attended more intervention sessions, and had better initial receptive language skills made greater progress during the course of the intervention. Conclusions A TA-delivered intervention produced improvements in the reading and language skills of children with Down syndrome. Gains were largest in skills directly taught with little evidence of generalization to skills not directly taught in the intervention. PMID:22533801

Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab.

PubMed

Ahmad, Harris; Berzin, Tyler M; Yu, Hui Jing; Huang, Christopher S; Mishkin, Daniel S

2014-08-01

Clinical trials in inflammatory bowel disease (IBD) are evolving at a rapid pace by employing central reading for endoscopic mucosal assessment in a field that was, historically, largely based on assessments by local physicians. This transition from local to central reading carries with it numerous technical, operational, and scientific challenges, many of which can be resolved by imaging core laboratories (ICLs), a concept that has a longer history in clinical trials in a number of diseases outside the realm of gastroenterology. For IBD trials, ICLs have the dual goals of providing objective, consistent assessments of endoscopic findings using central-reading paradigms whilst providing important expertise with regard to operational issues and regulatory expectations. This review focuses on current approaches to using ICLs for central endoscopic reading in IBD trials. © The Author(s) 2014. Published by Oxford University Press and the Digestive Science Publishing Co. Limited.

Publication of comparative effectiveness research has not increased in high-impact medical journals, 2004-2013.

PubMed

Hester, Laura L; Poole, Charles; Suarez, Elizabeth A; Der, Jane S; Anderson, Olivia G; Almon, Kathryn G; Shirke, Avanti V; Brookhart, M Alan

2017-04-01

To explore the impact of increasing interest and investment in patient-centered research, this study sought to describe patterns of comparative effectiveness research (CER) and patient-reported outcomes (PROs) in pharmacologic intervention studies published in widely read medical journals from 2004-2013. We identified 2335 articles published in five widely read medical journals from 2004-2013 with ≥1 intervention meeting the US Food and Drug Administration's definitions for a drug, biologic, or vaccine. Six trained reviewers extracted characteristics from a 20% random sample of articles (468 studies). We calculated the proportion of studies with CER and PROs. Trends were summarized using locally-weighted means and 95% confidence intervals. Of the 468 sampled studies, 30% used CER designs and 33% assessed PROs. The proportion of studies using CER designs did not meaningfully increase over the study period. However, we observed an increase in the use of PROs. Among pharmacological intervention studies published in widely read medical journals from 2004-2013, we identified no increase in CER. Randomized, placebo-controlled trials continue to be the dominant study design for assessing pharmacologic interventions. Increasing trends in PRO use may indicate greater acceptance of these outcomes as evidence for clinical benefit. Copyright © 2017 Elsevier Inc. All rights reserved.

Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research.

PubMed

Poduska, Jeanne; Kellam, Sheppard; Brown, C Hendricks; Ford, Carla; Windham, Amy; Keegan, Natalie; Wang, Wei

2009-09-02

While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. NCT00257088.

The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis.

PubMed

Feagan, Brian G; Sandborn, William J; D'Haens, Geert; Pola, Suresh; McDonald, John W D; Rutgeerts, Paul; Munkholm, Pia; Mittmann, Ulrich; King, Debra; Wong, Cindy J; Zou, Guangyong; Donner, Allan; Shackelton, Lisa M; Gilgen, Denise; Nelson, Sigrid; Vandervoort, Margaret K; Fahmy, Marianne; Loftus, Edward V; Panaccione, Remo; Travis, Simon P; Van Assche, Gert A; Vermeire, Séverine; Levesque, Barrett G

2013-07-01

Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these variations. We performed a 10-week, randomized, double-blind, placebo-controlled study of 281 patients with mildly to moderately active UC, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) sigmoidoscopy score ≥2, that evaluated the efficacy of delayed-release mesalamine (Asacol 800-mg tablet) 4.8 g/day. Endoscopic images were reviewed by a single expert central reader. The primary outcome was clinical remission (UCDAI, stool frequency and bleeding scores of 0, and no fecal urgency) at week 6. The primary outcome was achieved by 30.0% of patients treated with mesalamine and 20.6% of those given placebo, a difference of 9.4% (95% confidence interval [CI], -0.7% to 19.4%; P = .069). Significant differences in results from secondary analyses indicated the efficacy of mesalamine. Thirty-one percent of participants, all of whom had a UCDAI sigmoidoscopy score ≥2 as read by the site investigator, were considered ineligible by the central reader. After exclusion of these patients, the remission rates were 29.0% and 13.8% in the mesalamine and placebo groups, respectively (difference of 15%; 95% CI, 3.5%-26.0%; P = .011). Although mesalamine 4.8 g/day was not statistically different from placebo for induction of remission in patients with mildly to moderately active UC, based on an intent-to-treat analysis, the totality of the data supports a benefit of treatment. Central review of endoscopic images is critical to the conduct of induction studies in UC; ClinicalTrials.gov Number, NCT01059344. Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration.

PubMed

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.).

A Randomized Evaluation of the Success for All Middle School Reading Program

ERIC Educational Resources Information Center

Chamberlain, Anne; Daniels, Cecelia; Madden, Nancy A.; Slavin, Robert E.

2007-01-01

This article describes a randomized evaluation of The Reading Edge, a reading program for middle school students. The Reading Edge was designed to integrate findings of research on cooperative learning and metacognitive reading strategies into a replicable reading instructional package that could be implemented effectively in Title I middle…

Lay public's understanding of equipoise and randomisation in randomised controlled trials.

PubMed

Robinson, E J; Kerr, C E P; Stevens, A J; Lilford, R J; Braunholtz, D A; Edwards, S J; Beck, S R; Rowley, M G

2005-03-01

To research the lay public's understanding of equipoise and randomisation in randomised controlled trials (RCTs) and to look at why information on this may not be not taken in or remembered, as well as the effects of providing information designed to overcome barriers. Investigations were informed by an update of systematic review on patients' understanding of consent information in clinical trials, and by relevant theory and evidence from experimental psychology. Nine investigations were conducted with nine participants. Access (return to education), leisure and vocational courses at Further Education Colleges in the Midlands, UK. Healthy adults with a wide range of educational backgrounds and ages. Participants read hypothetical scenarios and wrote brief answers to subsequent questions. Sub-samples of participants were interviewed individually to elaborate on their written answers. Participants' background assumptions concerning equipoise and randomisation were examined and ways of helping participants recognise the scientific benefits of randomisation were explored. Judgments on allocation methods; treatment preferences; the acceptability of random allocation; whether or not individual doctors could be completely unsure about the best treatment; whether or not doctors should reveal treatment preferences under conditions of collective equipoise; and how sure experts would be about the best treatment following random allocation vs doctor/patient choice. Assessments of understanding hypothetical trial information. Recent literature continues to report trial participants' failure to understand or remember information about randomisation and equipoise, despite the provision of clear and readable trial information leaflets. In current best practice, written trial information describes what will happen without offering accessible explanations. As a consequence, patients may create their own incorrect interpretations and consent or refusal may be inadequately informed. In six investigations, most participants identified which methods of allocation were random, but judged the random allocation methods to be unacceptable in a trial context; the mere description of a treatment as new was insufficient to engender a preference for it over a standard treatment; around half of the participants denied that a doctor could be completely unsure about the best treatment. A majority of participants judged it unacceptable for a doctor to suggest letting chance decide when uncertain of the best treatment, and, in the absence of a justification for random allocation, participants did not recognise scientific benefits of random allocation over normal treatment allocation methods. The pattern of results across three intervention studies suggests that merely supplementing written trial information with an explanation is unlikely to be helpful. However, when people manage to focus on the trial's aim of increasing knowledge (as opposed to making treatment decisions about individuals), and process an explanation actively, they may be helped to understand the scientific reasons for random allocation. This research was not carried out in real healthcare settings. However, participants who could correctly identify random allocation methods, yet judged random allocation unacceptable, doubted the possibility of individual equipoise and saw no scientific benefits of random allocation over doctor/patient choice, are unlikely to draw upon contrasting views if invited to enter a real clinical trial. This suggests that many potential trial participants may have difficulty understanding and remembering trial information that conforms to current best practice in its descriptions of randomisation and equipoise. Given the extent of the disparity between the assumptions underlying trial design and the assumptions held by the lay public, the solution is unlikely to be simple. Nevertheless, the results suggest that including an accessible explanation of the scientific benefits of randomisation may be beneficial provided potential participants are also enabled to reflect on the trial's aim of advancing knowledge, and to think actively about the information presented. Further areas for consideration include: the identification of effective combinations of written and oral information; helping participants to reflect on the aim of advancing knowledge; and an evidence-based approach to leaflet construction.

Enduring effects of prenatal and infancy home visiting by nurses on children: follow-up of a randomized trial among children at age 12 years.

PubMed

Kitzman, Harriet J; Olds, David L; Cole, Robert E; Hanks, Carole A; Anson, Elizabeth A; Arcoleo, Kimberly J; Luckey, Dennis W; Knudtson, Michael D; Henderson, Charles R; Holmberg, John R

2010-05-01

To test the effect of prenatal and infancy home visits by nurses on 12-year-old, firstborn children's use of substances, behavioral adjustment, and academic achievement. Randomized controlled trial. Public system of obstetric and pediatric care in Memphis, Tennessee. We studied 12-year-old, firstborn children (n = 613) of primarily African American, economically disadvantaged women (743 randomized during pregnancy). Program of prenatal and infancy home visits by nurses. Use of cigarettes, alcohol, and marijuana; internalizing, externalizing, and total behavioral problems; and academic achievement. By the time the firstborn child was 12 years of age, those visited by nurses, compared with those in the control group, reported fewer days of having used cigarettes, alcohol, and marijuana during the 30-day period before the 12-year interview (0.03 vs 0.18, P = .02) and were less likely to report having internalizing disorders that met the borderline or clinical threshold (22.1% vs 30.9%, P = .04). Nurse-visited children born to mothers with low psychological resources, compared with their control group counterparts, scored higher on the Peabody Individual Achievement Tests in reading and math (88.78 vs 85.70, P = .009) and, during their first 6 years of education, scored higher on group-administered standardized tests of math and reading achievement (40.52 vs 34.85, P = .02). No statistically significant program effects were found on children's externalizing or total behavioral problems. Through age 12, the program reduced children's use of substances and internalizing mental health problems and improved the academic achievement of children born to mothers with low psychological resources.

Improving women's preconceptional health: findings from a randomized trial of the Strong Healthy Women intervention in the Central Pennsylvania women's health study.

PubMed

Hillemeier, Marianne M; Downs, Danielle Symons; Feinberg, Mark E; Weisman, Carol S; Chuang, Cynthia H; Parrott, Roxanne; Velott, Diana; Francis, Lori A; Baker, Sara A; Dyer, Anne-Marie; Chinchilli, Vernon M

2008-01-01

Improving the health of women before pregnancy is an important strategy for reducing adverse pregnancy outcomes for mother and child. This paper reports the first pretest-posttest results from a randomized trial of a unique, multidimensional, small group format intervention, Strong Healthy Women, designed to improve the health behaviors and health status of preconceptional and interconceptional women. Nonpregnant pre- and interconceptional women ages 18-35 were recruited in 15 low-income rural communities in Central Pennsylvania (n = 692). Women were randomized in a ratio of 2-to-1 to intervention and control groups; participants received a baseline and follow-up health risk assessment at 14 weeks and completed questionnaires to assess behavioral variables. The analytic sample for this report consists of 362 women who completed both risk assessments. Outcomes include measures of attitudinal and health-related behavior change. Women in the intervention group were significantly more likely than controls to report higher self-efficacy for eating healthy food and to perceive higher preconceptional control of birth outcomes; greater intent to eat healthy foods and be more physically active; and greater frequency of reading food labels, physical activity consistent with recommended levels, and daily use of a multivitamin with folic acid. Significant dose effects were found: Each additional intervention session attended was associated with higher perceived internal preconceptional control of birth outcomes, reading food labels, engaging in relaxation exercise or meditation for stress management, and daily use of a multivitamin with folic acid. The attitudinal and behavior changes attributable to the intervention were related primarily to nutrition and physical activity. These results show that these topics can be successfully addressed with pre- and interconceptional women outside the clinical setting in community-based interventions.

Eicosapentaenoic and docosahexaenoic acids, cognition, and behavior in children with attention-deficit/hyperactivity disorder: a randomized controlled trial.

PubMed

Milte, Catherine M; Parletta, Natalie; Buckley, Jonathan D; Coates, Alison M; Young, Ross M; Howe, Peter R C

2012-06-01

To determine the effects of an eicosapentaenoic acid (EPA)-rich oil and a docosahexaenoic acid (DHA)-rich oil versus an ω-6 polyunsaturated fatty acid-rich safflower oil (control) on literacy and behavior in children with attention-deficit/hyperactivity disorder (ADHD) in a randomized controlled trial. Supplements rich in EPA, DHA, or safflower oil were randomly allocated for 4 mo to 90 Australian children 7 to 12 y old with ADHD symptoms higher than the 90th percentile on the Conners Rating Scales. The effect of supplementation on cognition, literacy, and parent-rated behavior was assessed by linear mixed modeling. Pearson correlations determined associations between the changes in outcome measurements and the erythrocyte fatty acid content (percentage of total) from baseline to 4 mo. There were no significant differences between the supplement groups in the primary outcomes after 4 mo. However, the erythrocyte fatty acid profiles indicated that an increased proportion of DHA was associated with improved word reading (r = 0.394) and lower parent ratings of oppositional behavior (r = 0.392). These effects were more evident in a subgroup of 17 children with learning difficulties: an increased erythrocyte DHA was associated with improved word reading (r = 0.683), improved spelling (r = 0.556), an improved ability to divide attention (r = 0.676), and lower parent ratings of oppositional behavior (r = 0.777), hyperactivity (r = 0.702), restlessness (r = 0.705), and overall ADHD symptoms (r = 0.665). Increases in erythrocyte ω-3 polyunsaturated fatty acids, specifically DHA, may improve literacy and behavior in children with ADHD. The greatest benefit may be observed in children who have comorbid learning difficulties. Copyright © 2012 Elsevier Inc. All rights reserved.

Air charged and microtip catheters cannot be used interchangeably for urethral pressure measurement: a prospective, single-blind, randomized trial.

PubMed

Zehnder, Pascal; Roth, Beat; Burkhard, Fiona C; Kessler, Thomas M

2008-09-01

We determined and compared urethral pressure measurements using air charged and microtip catheters in a prospective, single-blind, randomized trial. A consecutive series of 64 women referred for urodynamic investigation underwent sequential urethral pressure measurements using an air charged and a microtip catheter in randomized order. Patients were blinded to the type and sequence of catheter used. Agreement between the 2 catheter systems was assessed using the Bland and Altman 95% limits of agreement method. Intraclass correlation coefficients of air charged and microtip catheters for maximum urethral closure pressure at rest were 0.97 and 0.93, and for functional profile length they were 0.9 and 0.78, respectively. Pearson's correlation coefficients and Lin's concordance coefficients of air charged and microtip catheters were r = 0.82 and rho = 0.79 for maximum urethral closure pressure at rest, and r = 0.73 and rho = 0.7 for functional profile length, respectively. When applying the Bland and Altman method, air charged catheters gave higher readings than microtip catheters for maximum urethral closure pressure at rest (mean difference 7.5 cm H(2)O) and functional profile length (mean difference 1.8 mm). There were wide 95% limits of agreement for differences in maximum urethral closure pressure at rest (-24.1 to 39 cm H(2)O) and functional profile length (-7.7 to 11.3 mm). For urethral pressure measurement the air charged catheter is at least as reliable as the microtip catheter and it generally gives higher readings. However, air charged and microtip catheters cannot be used interchangeably for clinical purposes because of insufficient agreement. Hence, clinicians should be aware that air charged and microtip catheters may yield completely different results, and these differences should be acknowledged during clinical decision making.

Comparison of Oral Reading Errors between Contextual Sentences and Random Words among Schoolchildren

ERIC Educational Resources Information Center

Khalid, Nursyairah Mohd; Buari, Noor Halilah; Chen, Ai-Hong

2017-01-01

This paper compares the oral reading errors between the contextual sentences and random words among schoolchildren. Two sets of reading materials were developed to test the oral reading errors in 30 schoolchildren (10.00±1.44 years). Set A was comprised contextual sentences while Set B encompassed random words. The schoolchildren were asked to…

Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.

PubMed

Greenley, Rachel Neff; Drotar, Dennis; Zyzanski, Stephen J; Kodish, Eric

2006-02-20

To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

Echocardiographic Methods, Quality Review, and Measurement Accuracy in a Randomized Multicenter Clinical Trial of Marfan Syndrome

PubMed Central

Selamet Tierney, Elif Seda; Levine, Jami C.; Chen, Shan; Bradley, Timothy J.; Pearson, Gail D.; Colan, Steven D.; Sleeper, Lynn A.; Campbell, M. Jay; Cohen, Meryl S.; Backer, Julie De; Guey, Lin T.; Heydarian, Haleh; Lai, Wyman W.; Lewin, Mark B.; Marcus, Edward; Mart, Christopher R.; Pignatelli, Ricardo H.; Printz, Beth F.; Sharkey, Angela M.; Shirali, Girish S.; Srivastava, Shubhika; Lacro, Ronald V.

2013-01-01

Background The Pediatric Heart Network is conducting a large international randomized trial to compare aortic root growth and other cardiovascular outcomes in 608 subjects with Marfan syndrome randomized to receive atenolol or losartan for 3 years. The authors report here the echocardiographic methods and baseline echocardiographic characteristics of the randomized subjects, describe the interobserver agreement of aortic measurements, and identify factors influencing agreement. Methods Individuals aged 6 months to 25 years who met the original Ghent criteria and had body surface area–adjusted maximum aortic root diameter (ROOTmax) Z scores > 3 were eligible for inclusion. The primary outcome measure for the trial is the change over time in ROOTmax Z score. A detailed echocardiographic protocol was established and implemented across 22 centers, with an extensive training and quality review process. Results Interobserver agreement for the aortic measurements was excellent, with intraclass correlation coefficients ranging from 0.921 to 0.989. Lower interobserver percentage error in ROOTmax measurements was independently associated (model R2 = 0.15) with better image quality (P = .002) and later study reading date (P < .001). Echocardiographic characteristics of the randomized subjects did not differ by treatment arm. Subjects with ROOTmax Z scores ≥ 4.5 (36%) were more likely to have mitral valve prolapse and dilation of the main pulmonary artery and left ventricle, but there were no differences in aortic regurgitation, aortic stiffness indices, mitral regurgitation, or left ventricular function compared with subjects with ROOTmax Z scores < 4.5. Conclusions The echocardiographic methodology, training, and quality review process resulted in a robust evaluation of aortic root dimensions, with excellent reproducibility. PMID:23582510

Does Health Literacy Level Influence the Effectiveness of a Kiosk-Based Intervention Delivered in the Pediatric Emergency Department?

PubMed

Shields, Wendy C; McDonald, Eileen M; McKenzie, Lara B; Gielen, Andrea C

2016-01-01

This study assesses parents' literacy skills and evaluates how literacy levels influenced the effectiveness of a health communication intervention designed to improve safety knowledge in low-income, urban families. A total of n = 450 parents of children aged 4 to 66 months completed the Rapid Estimate of Adult Literacy in Medicine (REALM) and participated in a randomized trial of an injury prevention intervention delivered via computer kiosk in a pediatric emergency department. A safety knowledge test was administered by telephone 2 to 4 weeks later. More than one-third of parents were assessed by the REALM to have marginal (30%) or inadequate (8%) reading levels; the remaining 62% of parents had adequate reading levels. REALM scores were independently associated with knowledge gains for poison storage and smoke alarms. Participants reading level had an independent and significant effect on safety knowledge outcomes. Literacy level should be considered in all patient education efforts. © The Author(s) 2015.

Improving word reading speed: individual differences interact with a training focus on successes or failures.

PubMed

Steenbeek-Planting, Esther G; van Bon, Wim H J; Schreuder, Robert

2012-10-01

The effect of two training procedures on the development of reading speed in poor readers is examined. One training concentrates on the words the children read correctly (successes), the other on the words they read incorrectly (failures). Children were either informed or not informed about the training focus. A randomized controlled trial was conducted with 79 poor readers. They repeatedly read regularly spelled Dutch consonant-vowel-consonant words, some children their successes, others their failures. The training used a computerized flashcards format. The exposure duration of the words was varied to maintain an accuracy rate at a constant level. Reading speed improved and transferred to untrained, orthographically more complex words. These transfer effects were characterized by an Aptitude-Treatment Interaction. Poor readers with a low initial reading level improved most in the training focused on successes. For poor readers with a high initial reading level, however, it appeared to be more profitable to practice with their failures. Informing students about the focus of the training positively affected training: The exposure duration needed for children informed about the focus of the training decreased more than for children who were not informed. This study suggests that neither of the two interventions is superior to the other in general. Rather, the improvement of general reading speed in a transparent orthography is closely related to both the children's initial reading level and the type of words they practice with: common and familiar words when training their successes and uncommon and less familiar words with training their failures.

High flow nasal cannula oxygen versus noninvasive ventilation in adult acute respiratory failure: a systematic review of randomized-controlled trials.

PubMed

Beng Leong, Lim; Wei Ming, Ng; Wei Feng, Lee

2018-06-19

We reviewed the use of noninvasive ventilation (NIV) versus high flow nasal cannula (HFNC) oxygen in adult acute respiratory failure (ARF). We searched major databases and included randomized trials comparing at least NIV with HFNC or NIV+HFNC with NIV in ARF. Primary outcomes included intubation/re-intubation rates. Secondary outcomes were ICU mortality and morbidities. Five trials were included; three compared HFNC with NIV, one compared HFNC, NIV and oxygen whereas one compared HFNC+NIV with NIV. Patients had hypoxaemic ARF (PaO2/FiO2≤300 mmHg). Heterogeneity prevented result pooling. Three and two studies had superiority and noninferiority design, respectively. Patients were postcardiothoracic surgery, mixed medical/surgical patients and those with pneumonia. Two trials were conducted after extubation, two before intubation and one during intubation. Three trials reported intubation/re-intubation rates as the primary outcomes. The other two trials reported the lowest peripheral capillary oxygen saturation readings during bronchoscopy or intubation. In the former three trials, the odds ratio for intubation/re-intubation rates between HFNC versus the NIV group ranged from 0.80 (95% confidence interval: 0.54-1.19) to 1.65 (95% confidence interval: 0.96-2.84). In the latter two trials, only one reported a difference in the lowest peripheral capillary oxygen saturation between NIV+HFNC versus the NIV group during intubation [100% (interquartile range: 95-100) vs. 96% (interquartile range: 92-99); P=0.029]. The secondary outcomes included differences in ICU mortality and patient tolerability, favouring HFNC, were conflicting, but highlighted future research directions. These include patients with hypercapneic ARF, more severe hypoxaemia (PaO2/FiO2≤200 mmHg), a superiority design, an oxygen arm and patient-centred outcomes.

The beneficial effects of cognitive training with simple calculation and reading aloud in an elderly postsurgical population: study protocol for a randomized controlled trial.

PubMed

Kulason, Kay; Nouchi, Rui; Hoshikawa, Yasushi; Noda, Masafumi; Okada, Yoshinori; Kawashima, Ryuta

2016-07-22

This project proposes a pilot study to investigate the positive healing effects of cognitive training with simple arithmetic and reading aloud on elderly postsurgical patients. Elderly patients undergoing surgery have an increased risk of Postoperative Cognitive Decline (POCD), a condition in which learning, memory, and processing speed is greatly reduced after surgery. Since elderly patients are more likely to exhibit symptoms of POCD, the incidence is increasing as the population receiving surgery has aged. Little effort has been expended, however, to find treatments for POCD. Learning therapy, which consists of a combination of reading aloud and solving simple arithmetic problems, was developed in Japan as a treatment for Alzheimer's Disease to improve cognitive functions. Because patients with Alzheimer's Disease experience similar issues as those with POCD in learning, memory, and processing speed, a cognitive intervention based on the learning-therapy treatments used for Alzheimer's Disease could show advantageous outcomes for those at risk of POCD. Cognitive function will be measured before and after surgery using three different tests (Mini-Mental Status Exam, Frontal Assessment Battery, and Cogstate computerized tests). Subjects will be randomly divided into two groups-one that receives a Simple Calculation and Reading Aloud intervention (SCRA) and a waitlisted control group that does not receive SCRA. To measure cognition before and after the intervention, the previously mentioned three tests will be used. The obtained data will be analyzed using statistical tests such as ANCOVA to indicate whether the cognitive intervention group has made improvements in their cognitive functions. In addition, questionnaires will also be administered to collect data on mental and emotional statuses. This report will be the first pilot study to investigate the beneficial effects of SCRA on elderly surgical patients. Previous studies have shown sufficient evidence on the effectiveness of learning therapy in healthy elderly people and in those with Dementia. Therefore, this study will clarify whether SCRA can improve cognitive function in the more specialized group of elderly surgical patients. University Hospital Medical Information Network Clinical Trial Registry, UMIN000019832 . Registered on 18 November 2015.

Cartoon versus traditional self-study handouts for medical students: CARTOON randomized controlled trial.

PubMed

Junhasavasdikul, Detajin; Sukhato, Kanokporn; Srisangkaew, Suthan; Theera-Ampornpunt, Nawanan; Anothaisintawee, Thunyarat; Dellow, Alan

2017-08-01

The objective of this study is to compare the effectiveness of a "cartoon-style" handout with a "traditional-style" handout in a self-study assignment for preclinical medical students. Third-year medical students (n = 93) at the Faculty of Medicine Ramathibodi Hospital, Mahidol University, took a pre-learning assessment of their knowledge of intercostal chest drainage. They were then randomly allocated to receive either a "cartoon-style" or a "traditional-style" handout on the same topic. After studying these over a 2-week period, students completed a post-learning assessment and estimated their levels of reading completion. Of the 79 participants completing the post-learning test, those in the cartoon-style group achieved a score 13.8% higher than the traditional-style group (p = 0.018). A higher proportion of students in the cartoon-style group reported reading ≥75% of the handout content (70.7% versus 42.1%). In post-hoc analyses, students whose cumulative grade point averages (GPA) from previous academic assessments were in the middle and lower range achieved higher scores with the cartoon-style handout than with the traditional one. In the lower-GPA group, the use of a cartoon-style handout was independently associated with a higher score. Students given a cartoon-style handout reported reading more of the material and achieved higher post-learning test scores than students given a traditional handout.

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

PubMed

Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation in chronic pain patients and will determine the feasibility of conducting a definitive randomized controlled trial. Patient recruitment began in January 2015 and is due to be completed in June 2016. ISRCTN61538090 Registered 20 April 2015.

Designing Caregiver-Implemented Shared-Reading Interventions to Overcome Implementation Barriers

PubMed Central

Logan, Jessica R.; Damschroder, Laura

2015-01-01

Purpose This study presents an application of the theoretical domains framework (TDF; Michie et al., 2005), an integrative framework drawing on behavior-change theories, to speech-language pathology. Methods A multistep procedure was used to identify barriers affecting caregivers' implementation of shared-reading interventions with their children with language impairment (LI). The authors examined caregiver-level data corresponding to implementation issues from two randomized controlled trials and mapped these to domains in the TDF as well as empirically validated behavior-change techniques. Results Four barriers to implementation were identified as potentially affecting caregivers' implementation: time pressures, reading difficulties, discomfort with reading, and lack of awareness of benefits. These were mapped to 3 TDF domains: intentions, beliefs about capabilities, and skills. In turn, 4 behavior-change techniques were identified as potential vehicles for affecting these domains: reward, feedback, model, and encourage. An ongoing study is described that is determining the effects of these techniques for improving caregivers' implementation of a shared-reading intervention. Conclusions A description of the steps to identifying barriers to implementation, in conjunction with an ongoing experiment that will explicitly determine whether behavior-change techniques affect these barriers, provides a model for how implementation science can be used to identify and overcome implementation barriers in the treatment of communication disorders. PMID:26262941

Designing Caregiver-Implemented Shared-Reading Interventions to Overcome Implementation Barriers.

PubMed

Justice, Laura M; Logan, Jessica R; Damschroder, Laura

2015-12-01

This study presents an application of the theoretical domains framework (TDF; Michie et al., 2005), an integrative framework drawing on behavior-change theories, to speech-language pathology. A multistep procedure was used to identify barriers affecting caregivers' implementation of shared-reading interventions with their children with language impairment (LI). The authors examined caregiver-level data corresponding to implementation issues from two randomized controlled trials and mapped these to domains in the TDF as well as empirically validated behavior-change techniques. Four barriers to implementation were identified as potentially affecting caregivers' implementation: time pressures, reading difficulties, discomfort with reading, and lack of awareness of benefits. These were mapped to 3 TDF domains: intentions, beliefs about capabilities, and skills. In turn, 4 behavior-change techniques were identified as potential vehicles for affecting these domains: reward, feedback, model, and encourage. An ongoing study is described that is determining the effects of these techniques for improving caregivers' implementation of a shared-reading intervention. A description of the steps to identifying barriers to implementation, in conjunction with an ongoing experiment that will explicitly determine whether behavior-change techniques affect these barriers, provides a model for how implementation science can be used to identify and overcome implementation barriers in the treatment of communication disorders.

Massage therapy for children with autism spectrum disorders: a systematic review.

PubMed

Lee, Myeong Soo; Kim, Jong-In; Ernst, Edzard

2011-03-01

We aimed to assess the effectiveness of massage as a treatment option for autism. We searched the following electronic databases using the time of their inception through March 2010: MEDLINE, AMED, CINAHL, EMBASE, PsycINFO, Health Technology Assessment, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Psychology and Behavioral Sciences Collection, 6 Korean medical databases (KSI, DBpia, KISTEP, RISS, KoreaMed, and National Digital Library), China Academic Journal (through China National Knowledge Infrastructure), and 3 Japanese medical databases (Journal@rchive, Science Links Japan, and Japan Science & Technology link). The search phrase used was "(massage OR touch OR acupressure) AND (autistic OR autism OR Asperger's syndrome OR pervasive developmental disorder)." The references in all located articles were also searched. No language restrictions were imposed. Prospective controlled clinical studies of any type of massage therapy for autistic patients were included. Trials in which massage was part of a complex intervention were also included. Case studies, case series, qualitative studies, uncontrolled trials, studies that failed to provide detailed results, and trials that compared one type of massage with another were excluded. All articles were read by 2 independent reviewers (M.S.L. and J-I.K.), who extracted data from the articles according to predefined criteria. Risk of bias was assessed using the Cochrane classification. Of 132 articles, only 6 studies met our inclusion criteria. One randomized clinical trial found that massage plus conventional language therapy was superior to conventional language therapy alone for symptom severity (P < .05) and communication attitude (P < .01). Two randomized clinical trials reported a significant benefit of massage for sensory profile (P < .01), adaptive behavior (P < .05), and language and social abilities (P < .01) as compared with a special education program. The fourth randomized clinical trial showed beneficial effects of massage for social communication (P < .05). Two nonrandomized controlled clinical trials suggested that massage therapy is effective. However, all of the included trials have high risk of bias. The main limitations of the included studies were small sample sizes, predefined primary outcome measures, inadequate control for nonspecific effects, and a lack of power calculations or adequate follow-up. Limited evidence exists for the effectiveness of massage as a symptomatic treatment of autism. Because the risk of bias was high, firm conclusions cannot be drawn. Future, more rigorous randomized clinical trials seem to be warranted. © Copyright 2011 Physicians Postgraduate Press, Inc.

Effect of the PREPARE Website vs an Easy-to-Read Advance Directive on Advance Care Planning Documentation and Engagement Among Veterans: A Randomized Clinical Trial.

PubMed

Sudore, Rebecca L; Boscardin, John; Feuz, Mariko A; McMahan, Ryan D; Katen, Mary T; Barnes, Deborah E

2017-08-01

Documentation rates of patients' medical wishes are often low. It is unknown whether easy-to-use, patient-facing advance care planning (ACP) interventions can overcome barriers to planning in busy primary care settings. To compare the efficacy of an interactive, patient-centered ACP website (PREPARE) with an easy-to-read advance directive (AD) to increase planning documentation. This was a comparative effectiveness randomized clinical trial from April 2013 to July 2016 conducted at multiple primary care clinics at the San Francisco VA Medical Center. Inclusion criteria were age of a least 60 years; at least 2 chronic and/or serious conditions; and 2 or more primary care visits; and 2 or more additional clinic, hospital, or emergency room visits in the last year. Participants were randomized to review PREPARE plus an easy-to-read AD or the AD alone. There were no clinician and/or system-level interventions or education. Research staff were blinded for all follow-up measurements. The primary outcome was new ACP documentation (ie, legal forms and/or discussions) at 9 months. Secondary outcomes included patient-reported ACP engagement at 1 week, 3 months, and 6 months using validated surveys of behavior change process measures (ie, 5-point knowledge, self-efficacy, readiness scales) and action measures (eg, surrogate designation, using a 0-25 scale). We used intention-to-treat, mixed-effects logistic and linear regression, controlling for time, health literacy, race/ethnicity, baseline ACP, and clustering by physician. The mean (SD) age of 414 participants was 71 (8) years, 38 (9%) were women, 83 (20%) had limited literacy, and 179 (43%) were nonwhite. No participant characteristic differed significantly among study arms at baseline. Retention at 6 months was 90%. Advance care planning documentation 6 months after enrollment was higher in the PREPARE arm vs the AD-alone arm (adjusted 35% vs 25%; odds ratio, 1.61 [95% CI, 1.03-2.51]; P = .04). PREPARE also resulted in higher self-reported ACP engagement at each follow-up, including higher process and action scores; P <.001 at each follow-up). Easy-to-use, patient-facing ACP tools, without clinician- and/or system-level interventions, can increase planning documentation 25% to 35%. Combining the PREPARE website with an easy-to-read AD resulted in higher planning documentation than the AD alone, suggesting that PREPARE may increase planning documentation with minimal health care system resources. clinicaltrials.gov Identifier: NCT01550731.

Reading Aloud, Play, and Social-Emotional Development.

PubMed

Mendelsohn, Alan L; Cates, Carolyn Brockmeyer; Weisleder, Adriana; Berkule Johnson, Samantha; Seery, Anne M; Canfield, Caitlin F; Huberman, Harris S; Dreyer, Benard P

2018-05-01

To determine impacts on social-emotional development at school entry of a pediatric primary care intervention (Video Interaction Project [VIP]) promoting positive parenting through reading aloud and play, delivered in 2 phases: infant through toddler (VIP birth to 3 years [VIP 0-3]) and preschool-age (VIP 3 to 5 years [VIP 3-5]). Factorial randomized controlled trial with postpartum enrollment and random assignment to VIP 0-3, control 0 to 3 years, and a third group without school entry follow-up (Building Blocks) and 3-year second random assignment of VIP 0-3 and control 0 to 3 years to VIP 3-5 or control 3 to 5 years. In the VIP, a bilingual facilitator video recorded the parent and child reading and/or playing using provided learning materials and reviewed videos to reinforce positive interactions. Social-emotional development at 4.5 years was assessed by parent-report Behavior Assessment System for Children, Second Edition (Social Skills, Attention Problems, Hyperactivity, Aggression, Externalizing Problems). VIP 0-3 and VIP 3-5 were independently associated with improved 4.5-year Behavior Assessment System for Children, Second Edition T-scores, with effect sizes (Cohen's d) ∼-0.25 to -0.30. Receipt of combined VIP 0-3 and VIP 3-5 was associated with d = -0.63 reduction in Hyperactivity ( P = .001). VIP 0-3 resulted in reduced "Clinically Significant" Hyperactivity (relative risk reduction for overall sample: 69.2%; P = .03; relative risk reduction for increased psychosocial risk: 100%; P = .006). Multilevel models revealed significant VIP 0-3 linear effects and age × VIP 3-5 interactions. Phase VIP 0-3 resulted in sustained impacts on behavior problems 1.5 years after program completion. VIP 3-5 had additional, independent impacts. With our findings, we support the use of pediatric primary care to promote reading aloud and play from birth to 5 years, and the potential for such programs to enhance social-emotional development. Copyright © 2018 by the American Academy of Pediatrics.

Effects of Study Design and Allocation on participant behaviour--ESDA: study protocol for a randomized controlled trial.

PubMed

Kypri, Kypros; McCambridge, Jim; Wilson, Amanda; Attia, John; Sheeran, Paschal; Bowe, Steve; Vater, Tina

2011-02-14

What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design). Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000846022.

Cognitive intervention through a training program for picture book reading in community-dwelling older adults: a randomized controlled trial.

PubMed

Suzuki, Hiroyuki; Kuraoka, Masataka; Yasunaga, Masashi; Nonaka, Kumiko; Sakurai, Ryota; Takeuchi, Rumi; Murayama, Yoh; Ohba, Hiromi; Fujiwara, Yoshinori

2014-11-21

Non-pharmacological interventions are expected to be important strategies for reducing the age-adjusted prevalence of senile dementia, considering that complete medical treatment for cognitive decline has not yet been developed. From the viewpoint of long-term continuity of activity, it is necessary to develop various cognitive stimulating programs. The aim of this study is to examine the effectiveness of a cognitive intervention through a training program for picture book reading for community-dwelling older adults. Fifty-eight Japanese older participants were divided into the intervention and control groups using simple randomization (n =29 vs 29). In the intervention group, participants took part in a program aimed at learning and mastering methods of picture book reading as a form of cognitive training intervention. The control group listened to lectures about elderly health maintenance. Cognitive tests were conducted individually before and after the programs. The rate of memory retention, computed by dividing Logical Memory delayed recall by immediate recall, showed a significant interaction (p < .05) in analysis of covariance. Simple main effects showed that the rate of memory retention of the intervention group improved after the program completion (p < .05). In the participants with mild cognitive impairment (MCI) examined by Japanese version of the Montreal Cognitive Assessment (MoCA-J) (n =14 vs 15), significant interactions were seen in Trail Making Test-A (p < .01), Trail Making Test-B (p < .05), Kana pick-out test (p < .05) and the Mini-Mental State Examination (p < .05). The intervention effect was found in delayed verbal memory. This program is also effective for improving attention and executive function in those with MCI. The short-term interventional findings suggest that this program might contribute to preventing a decline in memory and executive function. UMIN000014712 (Date of ICMJE and WHO compliant trial information disclosure: 30 July 2014).

Acquiring Science and Social Studies Knowledge in Kindergarten Through Fourth Grade: Conceptualization, Design, Implementation, and Efficacy Testing of Content-Area Literacy Instruction (CALI).

PubMed

Dombek, Jennifer; Crowe, Elizabeth C; Spencer, Mercedes; Tighe, Elizabeth L; Coffinger, Sean; Zargar, Elham; Wood, Taffeta; Petscher, Yaacov

2017-04-01

With national focus on reading and math achievement, science and social studies have received less instructional time. Yet, accumulating evidence suggests that content knowledge is an important predictor of proficient reading. Starting with a design study, we developed Content Area Literacy Instruction (CALI), as an individualized (or personalized) instructional program for kindergarteners through fourth graders to build science and social studies knowledge. We developed CALI to be implemented in general education classrooms, over multiple iterations (n=230 students), using principles of design-based implementation research. The aims were to develop CALI as a usable and feasible instructional program that would, potentially, improve science and social studies knowledge, and could be implemented during the literacy block without negatively affecting students' reading gains (i.e., no opportunity cost). We then evaluated the efficacy of CALI in a randomized controlled field trial with 418 students in kindergarten through fourth grade. Results reveal that CALI demonstrates promise as a useable and feasible instructional individualized general education program, and is efficacious in improving social studies ( d =2.2) and science ( d =2.1) knowledge, with some evidence of improving oral and reading comprehension skills ( d =.125).

Replication of an Experimental Study Investigating the Efficacy of a Multisyllabic Word Reading Intervention With and Without Motivational Beliefs Training for Struggling Readers.

PubMed

Toste, Jessica R; Capin, Philip; Williams, Kelly J; Cho, Eunsoo; Vaughn, Sharon

2018-05-01

This randomized control trial examined the efficacy of an intervention aimed at improving multisyllabic word reading (MWR) skills among fourth- and fifth-grade struggling readers ( n = 109, 48.6% male), as well as the relative effects of an embedded motivational beliefs training component. This study was a closely aligned replication of our earlier work. The intervention was replicated with a three-condition design: MWR only, MWR with a motivational beliefs component, and business-as-usual control. Students were tutored in small groups for 40 lessons (four 40-min lessons each week). When we combined performance of students in both MWR conditions, intervention students significantly outperformed controls on proximal measures of affix reading and MWR, as well as standardized measures of decoding, spelling, and text comprehension. Furthermore, there was a noted interaction between English learner status and treatment on spelling performance. There were no statistically significant main effects between the MWR groups on proximal or standardized measures of interest. Findings are discussed in terms of their relevance to MWR instruction for students with persistent reading difficulties and considerations for future research related to the malleability of motivation.

Testing an alternate informed consent process.

PubMed

Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

2009-01-01

One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

Closing the Achievement Gap through Modification of Neurocognitive and Neuroendocrine Function: Results from a Cluster Randomized Controlled Trial of an Innovative Approach to the Education of Children in Kindergarten

PubMed Central

Blair, Clancy; Raver, C. Cybele

2014-01-01

Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children’s engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap. PMID:25389751

Closing the achievement gap through modification of neurocognitive and neuroendocrine function: results from a cluster randomized controlled trial of an innovative approach to the education of children in kindergarten.

PubMed

Blair, Clancy; Raver, C Cybele

2014-01-01

Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children's engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap.

FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

PubMed Central

2014-01-01

Background The objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) or letrozole and zoledronic acid (LET + ZOL). Methods Patients were randomly assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 months. Primary endpoint was clinical response rate as assessed by mammogram readings. The study was terminated prematurely due to insufficient recruitment. We report here on an exploratory analysis of this data. Results Central assessment of tumor sizes during the treatment period was available for 131 patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm. Conclusion No increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET. However a trend towards a better reponse in the LET + ZOL arm could be observed. This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy, and it may support the evidence for a direct antitumor action of zoledronic acid. PMID:24499441

A Meta-Analysis of Red Yeast Rice: An Effective and Relatively Safe Alternative Approach for Dyslipidemia

PubMed Central

Li, Yinhua; Jiang, Long; Jia, Zhangrong; Xin, Wei; Yang, Shiwei; Yang, Qiu; Wang, Luya

2014-01-01

Objective To explore whether red yeast rice is a safe and effective alternative approach for dyslipidemia. Methods Pubmed, the Cochrane Library, EBSCO host, Chinese VIP Information (VIP), China National Knowledge Infrastructure (CNKI), Wanfang Databases were searched for appropriate articles. Randomized trials of RYR (not including Xuezhikang and Zhibituo) and placebo as control in patients with dyslipidemia were considered. Two authors read all papers and independently extracted all relevant information. The primary outcomes were serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C). The secondary outcomes were increased levels of alanine transaminase, aspartate aminotransferase, creatine kinase, creatinine and fasting blood glucose. Results A total of 13 randomized, placebo-controlled trials containing 804 participants were analyzed. Red yeast rice exhibited significant lowering effects on serum TC [WMD = −0.97 (95% CI: −1.13, −0.80) mmol/L, P<0.001], TG [WMD = −0.23 (95% CI: −0.31, −0.14) mmol/L, P<0.001], and LDL-C [WMD = −0.87 (95% CI: −1.03, −0.71) mmol/L, P<0.001] but no significant increasing effect on HDL-C [WMD = 0.08 (95% CI: −0.02, 0.19) mmol/L, P = 0.11] compared with placebo. No serious side effects were reported in all trials. Conclusions The meta-analysis suggests that red yeast rice is an effective and relatively safe approach for dyslipidemia. However, further long-term, rigorously designed randomized controlled trials are still warranted before red yeast rice could be recommended to patients with dyslipidemia, especially as an alternative to statins. PMID:24897342

Associations of reading posture, gaze angle and reading distance with myopia and myopic progression.

PubMed

Pärssinen, Olavi; Kauppinen, Markku

2016-12-01

To study the associations of habitual reading posture, gaze angle in reading and reading distance with myopia and changes in myopia among myopic children. A total of 240 myopic schoolchildren (mean age 10.9 years), with no previous spectacles, were recruited during 1983-1984 to a randomized 3-year clinical trial of bifocal treatment of myopia. Three annual examinations with subjective cycloplegic refraction were conducted for 237-238 subjects. A further examination was conducted at the mean age of 23.2 years for 178 subjects. Habitual reading posture was elicited by questionnaire at study outset. Reading distance was measured with a Clement Clark accommodometer and gaze angle with an angle scale at baseline and all three annual follow-ups. Height was measured by a school nurse. The connections between the variables were studied with the standard statistical methods. Higher myopia was connected with shorter reading distance among girls at follow-ups 2 and 3, but not at the other examinations. The correlation of spherical equivalent with height was non-significant at each follow-up. Myopic progression across the whole follow-up was highest among those who read sitting down at baseline (-3.58 ± 1.75 D) and lowest among those who read face up lying down (-2.35 ± 1.53 D) (p = 0.021). Reading with eyes at a more downward angle was slightly connected with greater myopic progression (r = -0.166, p = 0.028). Reading in a sitting posture at myopia onset predicted the greatest myopic progression to adulthood and reading face up on one's back the lowest. Reading with eyes on turned more downwards was slightly connected with greater myopic progression. © 2016 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

The efficacy of early language intervention in mainstream school settings: a randomized controlled trial.

PubMed

Fricke, Silke; Burgoyne, Kelly; Bowyer-Crane, Claudine; Kyriacou, Maria; Zosimidou, Alexandra; Maxwell, Liam; Lervåg, Arne; Snowling, Margaret J; Hulme, Charles

2017-10-01

Oral language skills are a critical foundation for literacy and more generally for educational success. The current study shows that oral language skills can be improved by providing suitable additional help to children with language difficulties in the early stages of formal education. We conducted a randomized controlled trial with 394 children in England, comparing a 30-week oral language intervention programme starting in nursery (N = 132) with a 20-week version of the same programme starting in Reception (N = 133). The intervention groups were compared to an untreated waiting control group (N = 129). The programmes were delivered by trained teaching assistants (TAs) working in the children's schools/nurseries. All testers were blind to group allocation. Both the 20- and 30-week programmes produced improvements on primary outcome measures of oral language skill compared to the untreated control group. Effect sizes were small to moderate (20-week programme: d = .21; 30-week programme: d = .30) immediately following the intervention and were maintained at follow-up 6 months later. The difference in improvement between the 20-week and 30-week programmes was not statistically significant. Neither programme produced statistically significant improvements in children's early word reading or reading comprehension skills (secondary outcome measures). This study provides further evidence that oral language interventions can be delivered successfully by trained TAs to children with oral language difficulties in nursery and Reception classes. The methods evaluated have potentially important policy implications for early education. © 2017 Association for Child and Adolescent Mental Health.

Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses.

PubMed

Sivardeen, Ahmed; Laughton, Deborah; Wolffsohn, James S

2016-02-01

To assess the performance of four commercially available silicone hydrogel multifocal monthly contact lens designs against monovision. A double-masked randomized crossover trial of Air Optix Aqua multifocal, PureVision 2 for Presbyopia, Acuvue OASYS for Presbyopia, Biofinity multifocal, and monovision with Biofinity contact lenses was conducted on 35 presbyopes (54.3 ± 6.2 years). After 4 weeks of wear, visual performance was quantified by high- and low-contrast visual acuity under photopic and mesopic conditions, reading speed, defocus curves, stereopsis, halometry, aberrometry, Near Activity Visual Questionnaire rating, and subjective quality of vision scoring. Bulbar, limbal, and palpebral hyperemia and corneal staining were graded to monitor the impact of each contact lens on ocular physiology. High-contrast photopic visual acuity (p = 0.102), reading speed (F = 1.082, p = 0.368), and aberrometry (F = 0.855, p = 0.493) were not significantly different between presbyopic lens options. Defocus curve profiles (p < 0.001), stereopsis (p < 0.001), halometry (F = 4.101, p = 0.004), Near Activity Visual Questionnaire (F = 3.730, p = 0.007), quality of vision (p = 0.002), bulbar hyperemia (p = 0.020), and palpebral hyperemia (p = 0.012) differed significantly between lens types, with the Biofinity multifocal lens design principal (center-distance lens was fitted to the dominant eye and a center-near lens to the nondominant eye) typically outperforming the other lenses. Although ocular aberration variation between individuals largely masks the differences in optics between current multifocal contact lens designs, certain design strategies can outperform monovision, even in early presbyopes.

A cluster randomized controlled trial to assess the effectiveness of an intervention to educate students about depression.

PubMed

Merritt, Rowena K; Price, Jonathan R; Mollison, Jill; Geddes, John R

2007-03-01

Depression is an important cause of disability worldwide, with many people experiencing their first depressive episode before the age of 18. University students are particularly vulnerable to depression. Depression can be treated successfully in most patients. However, for treatment to be successful, depressed people need to recognize their symptoms as illness, present to medical care, and be aware that effective treatment is available. A thoughtful health campaign might therefore increase the likelihood of successful treatment. A cluster randomized controlled trial was conducted to determine the effectiveness of an educational intervention. A total of 3313 undergraduate students participated in the study. The intervention consisted of postcards and posters on depression and its treatment. The primary outcome was student awareness that depression can be treated effectively. Secondary outcomes included the proportion of students reading the postcards, recognition of symptoms and knowledge of treatments. The postcards were read by 69% of students. Less than half of participants reported that depression could be treated effectively, and there was no evidence of a difference between the intervention and control groups [341 (49.1%) v. 379 (49.7%), difference -0.7, p=0.8, 95% confidence interval (CI) -5.1 to 3.7]. However, intervention group participants were more likely than control group participants to recognize depressive symptoms and to report that antidepressants are not addictive. Many university students lack knowledge about depression and its treatment. Simple and cheap media, such as postcards and posters, might help to improve awareness in areas where current knowledge is low.

Cost analysis of colorectal cancer screening with CT colonography in Italy.

PubMed

Mantellini, Paola; Lippi, Giuseppe; Sali, Lapo; Grazzini, Grazia; Delsanto, Silvia; Mallardi, Beatrice; Falchini, Massimo; Castiglione, Guido; Carozzi, Francesca Maria; Mascalchi, Mario; Milani, Stefano; Ventura, Leonardo; Zappa, Marco

2018-06-01

Unit costs of screening CT colonography (CTC) can be useful for cost-effectiveness analyses and for health care decision-making. We evaluated the unit costs of CTC as a primary screening test for colorectal cancer in the setting of a randomized trial in Italy. Data were collected within the randomized SAVE trial. Subjects were invited to screening CTC by mail and requested to have a pre-examination consultation. CTCs were performed with 64- and 128-slice CT scanners after reduced or full bowel preparation. Activity-based costing was used to determine unit costs per-process, per-participant to screening CTC, and per-subject with advanced neoplasia. Among 5242 subjects invited to undergo screening CTC, 1312 had pre-examination consultation and 1286 ultimately underwent CTC. Among 129 subjects with a positive CTC, 126 underwent assessment colonoscopy and 67 were ultimately diagnosed with advanced neoplasia (i.e., cancer or advanced adenoma). Cost per-participant of the entire screening CTC pathway was €196.80. Average cost per-participant for the screening invitation process was €17.04 and €9.45 for the pre-examination consultation process. Average cost per-participant of the CTC execution and reading process was €146.08 and of the diagnostic assessment colonoscopy process was €24.23. Average cost per-subject with advanced neoplasia was €3777.30. Cost of screening CTC was €196.80 per-participant. Our data suggest that the more relevant cost of screening CTC, amenable of intervention, is related to CTC execution and reading process.

Improving informed consent to chemotherapy: a randomized controlled trial of written information versus an interactive multimedia CD-ROM.

PubMed

Olver, Ian N; Whitford, Hayley S; Denson, Linley A; Peterson, Melissa J; Olver, Scott I

2009-02-01

This randomized controlled trial aimed to determine whether an interactive CD-ROM improved cancer patients' recall of chemotherapy treatment information over standard written information, and whether demographic, cognitive, and psychological factors better predicted recall than this format of delivery. One-hundred-and-one new patients about to commence chemotherapy were randomized to receive written information or a CD-ROM containing treatment information before giving informed consent. Patients' recall, concentration, short-term memory, reading comprehension, anxiety, depression, and coping styles were assessed with standardized measures pre-treatment. Seventy-seven patients completed tests for recall of treatment information before their second chemotherapy session. Intention-to-treat analyses indicated no significant differences between the written information and CD-ROM groups across recall questions about number of drugs received (p=.43), treatment length (p=.23), and treatment goal (p=.69). Binary logistic regressions indicated that for groups combined different variables predicted each of the recall questions. An interactive CD-ROM did not improve cancer patients' recall of treatment information enough to warrant changes in consent procedures. Different variables predicted recall of different treatment aspects highlighting the complex nature of attempting to improve patient recall. Attending to the effect of depression on patient knowledge and understanding appears paramount.

Mental health first aid training by e-learning: a randomized controlled trial.

PubMed

Jorm, Anthony F; Kitchener, Betty A; Fischer, Julie-Anne; Cvetkovski, Stefan

2010-12-01

Mental Health First Aid training is a course for the public that teaches how to give initial help to a person developing a mental health problem or in a mental health crisis. The present study evaluated the effects of Mental Health First Aid training delivered by e-learning on knowledge about mental disorders, stigmatizing attitudes and helping behaviour. A randomized controlled trial was carried out with 262 members of the Australian public. Participants were randomly assigned to complete an e-learning CD, read a Mental Health First Aid manual or be in a waiting list control group. The effects of the interventions were evaluated using online questionnaires pre- and post-training and at 6-months follow up. The questionnaires covered mental health knowledge, stigmatizing attitudes, confidence in providing help to others, actions taken to implement mental health first aid and participant mental health. Both e-learning and the printed manual increased aspects of knowledge, reduced stigma and increased confidence compared to waiting list. E-learning also improved first aid actions taken more than waiting list, and was superior to the printed manual in reducing stigma and disability due to mental ill health. Mental Health First Aid information received by either e-learning or printed manual had positive effects, but e-learning was better at reducing stigma.

Repeated Reading Intervention: Outcomes and Interactions with Readers' Skills and Classroom Instruction

ERIC Educational Resources Information Center

Vadasy, Patricia F.; Sanders, Elizabeth A.

2008-01-01

This study examined effects of a repeated reading intervention, Quick Reads, with incidental word-level scaffolding instruction. Second- and third-grade students with passage-reading fluency performance between the 10th and 60th percentiles were randomly assigned to dyads, which were in turn randomly assigned to treatment (paired tutoring, n = 82)…

Peer tutoring in reading: the effects of role and organization on two dimensions of self-esteem.

PubMed

Miller, David; Topping, Keith; Thurston, Allen

2010-09-01

Paired reading (PR) is an application of peer tutoring. It has been extensively researched, and its efficacy across a range of outcomes has been established. Benefits include improvements in key reading skills, and also in affective aspects of learning. Several studies have shown gains in self-esteem, although measurement methods have varied, and the model of self-esteem has rarely been clearly articulated. To investigate the changes in self-esteem of children participating in a randomized trial of PR over a 15-week treatment period. To investigate the relative contribution of self-worth and self-competence to any gains in self-esteem. To investigate whether the pattern of change differs in children who take on different roles in the PR process. The participants comprised a subset of a large-scale randomized trial of peer learning (The Fife Peer Learning Project). Four schools were randomly selected from schools allocated to the same-age PR condition, and four schools from those allocated to the cross-age PR condition. The same-age group consisted of 87 primary 6 children (10-11 years old). The cross-age group consisted of 81 primary 6 children. The controls, from schools randomly selected from a neighbouring authority, consisted of 92 primary 6 children. A pre-post design employing self-report measures of self-esteem. Rosenberg's Self-Esteem Scale was used, with scores analysed for worth and competence. The treatment period was 15 weeks, with the participants following a prescribed PR process. Significant pre-post gains were noted in self-esteem, driven predominantly by improved beliefs about competence, in both same-age and cross-age conditions, but not for controls. Gains were also seen in self-worth in the cross-age condition. Further analyses of the influence of organizational condition (same-age or cross-age) and role played (tutor vs. tutee) showed significant differences between same-age tutors and cross-age tutors in relation to self-worth. Effect sizes were generally small or moderate. The findings provide further support for the belief that PR can enhance self-esteem. Importantly, the use of a two-dimensional model provides extra information about self-perceptions in PR contexts: first, the central role of self-competence; and second, the gains in self-worth which are associated with tutoring younger children (but not same-age peers). This new information has educational significance for schools considering the potential of peer tutoring and the benefits of different organizational conditions.

Informed consent in otologic surgery: prospective randomized study comparing risk recall with an illustrated handout and a nonillustrated handout.

PubMed

Henry, Eric; Brown, Timothy; Bartlett, Clark; Massoud, Emad; Bance, Manohar

2008-04-01

Following consent, do pictures in a handout improve patients' recall of otologic surgical risks? Prospective, randomized trial in a tertiary care centre. Patients undergoing otologic surgery were consented with a standardized checklist of risks by two surgeons. They were randomized (stratified by educational level) to receive either a pure text or a text and pictures handout outlining the risks of surgery. A telephone interview tested recall at a mean of 19 days. Twenty-six patients were resampled at 1 year. Recall was analyzed with respect to type of handout, age, sex, and level of education. A subset of 31 patients was analyzed for the effects of which surgeon consented, previous otologic surgery, and actually reading the handout. Fifty-one patients completed the study. The overall risk recall was 43%, with 45% in the pictorial group and 42% in the pure text group (p = .84). The illustrated handout did not improve the recall of any individual surgical risk either. Higher education improved risk recall from 36 to 54% (p = .009). Age, consenting surgeon, previous otologic surgery, and even reading the handout did not improve risk recall. A subgroup of 26 patients was followed up 1 year later, and their recall fell from 41 to 35%. The illustrated handout did not improve long-term recall (p = .674). Pictorial cues do not improve recall of surgical risks, but education level does.

The Nation's Report Card Reading 2009 Trial Urban District Snapshot Report. Austin Independent School District. Grade 4, Public Schools

ERIC Educational Resources Information Center

National Center for Education Statistics, 2010

2010-01-01

Each district that participated in the National Assessment of Educational Progress (NAEP) 2009 Trial Urban District Assessment in reading receives a one-page snapshot report that presents key findings and trends in a condensed format. This report presents the results for Austin Independent School District's student achievement in reading. In 2009,…

The Nation's Report Card Reading 2009 Trial Urban District Snapshot Report. Austin Independent School District. Grade 8, Public Schools

ERIC Educational Resources Information Center

National Center for Education Statistics, 2010

2010-01-01

Each district that participated in the National Assessment of Educational Progress (NAEP) 2009 Trial Urban District Assessment in reading receives a one-page snapshot report that presents key findings and trends in a condensed format. This report presents the results for Austin Independent School District's student achievement in reading. In 2009,…

The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial.

PubMed

Kulason, Kay; Nouchi, Rui; Hoshikawa, Yasushi; Noda, Masafumi; Okada, Yoshinori; Kawashima, Ryuta

2018-01-01

Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA) cognitive training in elderly Japanese postsurgical patients. Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited ( n = 12). Subjects were randomly divided into two groups-one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J), Frontal Assessment Battery (FAB), computerized Cogstate Brief Battery (CBB)] and emotional state [General Health Questionnaire-12 (GHQ-12), Geriatric Depression Scale (GDS), Quality of Life Scale-5 (QOL-5)]. Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved. Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions. Trial registration: This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN000019832).

The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial

PubMed Central

Kulason, Kay; Nouchi, Rui; Hoshikawa, Yasushi; Noda, Masafumi; Okada, Yoshinori; Kawashima, Ryuta

2018-01-01

Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA) cognitive training in elderly Japanese postsurgical patients. Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited (n = 12). Subjects were randomly divided into two groups—one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J), Frontal Assessment Battery (FAB), computerized Cogstate Brief Battery (CBB)] and emotional state [General Health Questionnaire-12 (GHQ-12), Geriatric Depression Scale (GDS), Quality of Life Scale-5 (QOL-5)]. Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved. Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions. Trial registration: This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN000019832). PMID:29643802

Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes.

PubMed

Istepanian, Robert S H; Zitouni, Karima; Harry, Diane; Moutosammy, Niva; Sungoor, Ala; Tang, Bee; Earle, Kenneth A

2009-01-01

We conducted a randomized controlled trial using mobile health technology in an ethnically diverse sample of 137 patients with complicated diabetes. Patients in the intervention group (n = 72) were trained to measure their blood glucose with a sensor which transmitted the readings to a mobile phone via a Bluetooth wireless link. Clinicians were then able to examine and respond to the readings which were viewed with a web-based application. Patients in the control arm of the study (n = 65) did not transmit their readings and received care with their usual doctor in the outpatient and/or primary care setting. The mean follow-up period was 9 months in each group. The default rate was higher in the patients in the intervention arm due to technical problems. In an intention-to-treat analysis there were no differences in HbA(1c) between the intervention and control groups. In a sub-group analysis of the patients who completed the study, the telemonitoring group had a lower HbA(1c) than those in the control group: 7.76% and 8.40%, respectively (P = 0.06).

Listening to Quackery: Reading John Wesley's Primitive Physic in an Age of Health Care Reform.

PubMed

Skinner, Daniel; Schneider, Adam

2016-11-25

This article uses a reading of John Wesley's Primitive Physic, or An Easy and Natural Method of Curing Most Diseases (1747) to resist the common rejection-often as "quackery"-of Wesley's treatments for common maladies. We engage Wesley not because he was right but because his approach offers useful moments of pause in light of contemporary medical epistemology. Wesley's recommendations were primarily oriented towards the categories of personal responsibility and capability, but he also sought to empower individuals-especially the poor-with the knowledge to safely and affordably treat maladies of their own. We leverage Primitive Physic to rethink contemporary medical knowledge production, especially as sanctioned by randomized clinical trials and legitimate views of experience and contemporary institutions such as the AMA. Ultimately, we suggest that the medical humanities has a key role to play in mining the discarded and dismissed for what they can tell scholars about medical knowledge.

A "novel" intervention: a pilot study of children's literature and healthy lifestyles.

PubMed

Bravender, Terrill; Russell, Alexandra; Chung, Richard J; Armstrong, Sarah C

2010-03-01

To determine if reading an age-appropriate novel has the potential to improve BMI percentile and exercise- and nutrition-related knowledge and behaviors in girls aged 9 to 13 years who were enrolled in a childhood obesity-treatment program. This preliminary, randomized, controlled trial followed 81 obese girls aged 9 to 13 years who were enrolled in the Duke University Healthy Lifestyles Program, a comprehensive clinical and behavioral lifestyle-modification program for overweight and obese children. Thirty-one girls were randomly assigned to read the intervention novel, which describes an overweight girl who discovers improved health and self-efficacy, and 33 participants were given a control novel to read. Participants were evaluated at the study intake and again at their scheduled follow-up appointments 1 to 2 months later. Intake and follow-up BMI percentiles were evaluated for 17 girls in the program who did not receive either book. Follow-up data were available for 11 of 31 girls in the intervention-book group, 14 of 33 girls in the control-book group, and 14 of 17 girls who did not receive a book. There was a significantly greater reduction in BMI percentile among those in the intervention-book group (-0.71) versus those in the control-book group (-0.33; P = .03). Girls who read either book had a significantly greater reduction in BMI percentile (-0.49) than girls who were followed in the program but who were not assigned a book (0.05; P = .02). Age-appropriate fiction, particularly if it addresses health-oriented behaviors, shows potential for augmenting weight loss in girls who participate in a weight-management program. Future research is needed to determine if the novel is effective for healthy lifestyle promotion among all overweight and obese adolescents.

The Nation's Report Card Reading 2009 Trial Urban District Snapshot Report. San Diego Unified School District. Grade 8, Public Schools

ERIC Educational Resources Information Center

National Center for Education Statistics, 2010

2010-01-01

Each district that participated in the National Assessment of Educational Progress (NAEP) 2009 Trial Urban District Assessment in reading receives a one-page snapshot report that presents key findings and trends in a condensed format. This report presents the results for San Diego Unified School District's student achievement in reading. In 2009,…

The Nation's Report Card Reading 2009 Trial Urban District Snapshot Report. San Diego Unified School District. Grade 4, Public Schools

ERIC Educational Resources Information Center

National Center for Education Statistics, 2010

2010-01-01

Each district that participated in the National Assessment of Educational Progress (NAEP) 2009 Trial Urban District Assessment in reading receives a one-page snapshot report that presents key findings and trends in a condensed format. This report presents the results for San Diego Unified School District's student achievement in reading. In 2009,…

Evidence-based interventions for reading and language difficulties: creating a virtuous circle.

PubMed

Snowling, Margaret J; Hulme, Charles

2011-03-01

BACKGROUND. Children may experience two very different forms of reading problem: decoding difficulties (dyslexia) and reading comprehension difficulties. Decoding difficulties appear to be caused by problems with phonological (speech sound) processing. Reading comprehension difficulties in contrast appear to be caused by problems with 'higher level' language difficulties including problems with semantics (including deficient knowledge of word meanings) and grammar (knowledge of morphology and syntax). AIMS. We review evidence concerning the nature, causes of, and treatments for children's reading difficulties. We argue that any well-founded educational intervention must be based on a sound theory of the causes of a particular form of learning difficulty, which in turn must be based on an understanding of how a given skill is learned by typically developing children. Such theoretically motivated interventions should in turn be evaluated in randomized controlled trials (RCTs) to establish whether they are effective, and for whom. RESULTS. There is now considerable evidence showing that phonologically based interventions are effective in ameliorating children's word level decoding difficulties, and a smaller evidence base showing that reading and oral language (OL) comprehension difficulties can be ameliorated by suitable interventions to boost vocabulary and broader OL skills. CONCLUSIONS. The process of developing theories about the origins of children's educational difficulties and evaluating theoretically motivated treatments in RCTs, produces a 'virtuous circle' whereby theory informs practice, and the evaluation of effective interventions in turn feeds back to inform and refine theories about the nature and causes of children's reading and language difficulties. ©2010 The British Psychological Society.

Comparison of reading speed with 3 different log-scaled reading charts.

PubMed

Buari, Noor Halilah; Chen, Ai-Hong; Musa, Nuraini

2014-01-01

A reading chart that resembles real reading conditions is important to evaluate the quality of life in terms of reading performance. The purpose of this study was to compare the reading speed of UiTM Malay related words (UiTM-Mrw) reading chart with MNread Acuity Chart and Colenbrander Reading Chart. Fifty subjects with normal sight were randomly recruited through randomized sampling in this study (mean age=22.98±1.65 years). Subjects were asked to read three different near charts aloud and as quickly as possible at random sequence. The charts were the UiTM-Mrw Reading Chart, MNread Acuity Chart and Colenbrander Reading Chart, respectively. The time taken to read each chart was recorded and any errors while reading were noted. Reading performance was quantified in terms of reading speed as words per minute (wpm). The mean reading speed for UiTM-Mrw Reading Chart, MNread Acuity Chart and Colenbrander Reading Chart was 200±30wpm, 196±28wpm and 194±31wpm, respectively. Comparison of reading speed between UiTM-Mrw Reading Chart and MNread Acuity Chart showed no significant difference (t=-0.73, p=0.72). The same happened with the reading speed between UiTM-Mrw Reading Chart and Colenbrander Reading Chart (t=-0.97, p=0.55). Bland and Altman plot showed good agreement between reading speed of UiTM-Mrw Reading Chart with MNread Acuity Chart with the Colenbrander Reading Chart. UiTM-Mrw Reading Chart in Malay language is highly comparable with standardized charts and can be used for evaluating reading speed. Copyright © 2013 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Comparison of reading speed with 3 different log-scaled reading charts

PubMed Central

Buari, Noor Halilah; Chen, Ai-Hong; Musa, Nuraini

2014-01-01

Background A reading chart that resembles real reading conditions is important to evaluate the quality of life in terms of reading performance. The purpose of this study was to compare the reading speed of UiTM Malay related words (UiTM-Mrw) reading chart with MNread Acuity Chart and Colenbrander Reading Chart. Materials and methods Fifty subjects with normal sight were randomly recruited through randomized sampling in this study (mean age = 22.98 ± 1.65 years). Subjects were asked to read three different near charts aloud and as quickly as possible at random sequence. The charts were the UiTM-Mrw Reading Chart, MNread Acuity Chart and Colenbrander Reading Chart, respectively. The time taken to read each chart was recorded and any errors while reading were noted. Reading performance was quantified in terms of reading speed as words per minute (wpm). Results The mean reading speed for UiTM-Mrw Reading Chart, MNread Acuity Chart and Colenbrander Reading Chart was 200 ± 30 wpm, 196 ± 28 wpm and 194 ± 31 wpm, respectively. Comparison of reading speed between UiTM-Mrw Reading Chart and MNread Acuity Chart showed no significant difference (t = −0.73, p = 0.72). The same happened with the reading speed between UiTM-Mrw Reading Chart and Colenbrander Reading Chart (t = −0.97, p = 0.55). Bland and Altman plot showed good agreement between reading speed of UiTM-Mrw Reading Chart with MNread Acuity Chart with the Colenbrander Reading Chart. Conclusion UiTM-Mrw Reading Chart in Malay language is highly comparable with standardized charts and can be used for evaluating reading speed. PMID:25323642

A pilot randomized controlled trial comparing effectiveness of prism glasses, visual search training and standard care in hemianopia.

PubMed

Rowe, F J; Conroy, E J; Bedson, E; Cwiklinski, E; Drummond, A; García-Fiñana, M; Howard, C; Pollock, A; Shipman, T; Dodridge, C; MacIntosh, C; Johnson, S; Noonan, C; Barton, G; Sackley, C

2017-10-01

Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only). Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units. Stroke survivors with homonymous hemianopia. Arm a (Fresnel prisms) for minimum 2 hours, 5 days per week over 6 weeks. Arm b (visual search training) for minimum 30 minutes, 5 days per week over 6 weeks. Arm c (standard care-information only). Adult stroke survivors (>18 years), stable hemianopia, visual acuity better than 0.5 logMAR, refractive error within ±5 dioptres, ability to read/understand English and provide consent. Primary outcomes were change in visual field area from baseline to 26 weeks and calculation of sample size for a definitive trial. Secondary measures included Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual, Short Form-12 questionnaires and Radner reading ability. Measures were post-randomization at baseline and 6, 12 and 26 weeks. Randomization block lists stratified by site and partial/complete hemianopia. Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation. Eighty-seven patients were recruited: 27-Fresnel prisms, 30-visual search training and 30-standard care; 69% male; mean age 69 years (SD 12). At 26 weeks, full results for 24, 24 and 22 patients, respectively, were compared to baseline. Sample size calculation for a definitive trial determined as 269 participants per arm for a 200 degree 2 visual field area change at 90% power. Non-significant relative change in area of visual field was 5%, 8% and 3.5%, respectively, for the three groups. Visual Function Questionnaire responses improved significantly from baseline to 26 weeks with visual search training (60 [SD 19] to 68.4 [SD 20]) compared to Fresnel prisms (68.5 [SD 16.4] to 68.2 [18.4]: 7% difference) and standard care (63.7 [SD 19.4] to 59.8 [SD 22.7]: 10% difference), P=.05. Related adverse events were common with Fresnel prisms (69.2%; typically headaches). No significant change occurred for area of visual field area across arms over follow-up. Visual search training had significant improvement in vision-related quality of life. Prism therapy produced adverse events in 69%. Visual search training results warrant further investigation. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Dose-dependent social-cognitive effects of intranasal oxytocin delivered with novel Breath Powered device in adults with autism spectrum disorder: a randomized placebo-controlled double-blind crossover trial

PubMed Central

Quintana, D S; Westlye, L T; Hope, S; Nærland, T; Elvsåshagen, T; Dørum, E; Rustan, Ø; Valstad, M; Rezvaya, L; Lishaugen, H; Stensønes, E; Yaqub, S; Smerud, K T; Mahmoud, R A; Djupesland, P G; Andreassen, O A

2017-01-01

The neuropeptide oxytocin has shown promise as a treatment for symptoms of autism spectrum disorders (ASD). However, clinical research progress has been hampered by a poor understanding of oxytocin’s dose–response and sub-optimal intranasal delivery methods. We examined two doses of oxytocin delivered using a novel Breath Powered intranasal delivery device designed to improve direct nose-to-brain activity in a double-blind, crossover, randomized, placebo-controlled trial. In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks. We observed an omnibus main effect of treatment on the primary outcome measure of overt emotion salience as measured by emotional ratings of faces (η2=0.18). Compared to placebo, 8IU treatment increased overt emotion salience (P=0.02, d=0.63). There was no statistically significant increase after 24IU treatment (P=0.12, d=0.4). The effects after 8IU oxytocin were observed despite no significant increase in peripheral blood plasma oxytocin concentrations. We found no significant effects for reading the mind in the eyes task performance or secondary outcome social-cognitive tasks (emotional dot probe and face-morphing). To our knowledge, this is the first trial to assess the dose-dependent effects of a single oxytocin administration in autism, with results indicating that a low dose of oxytocin can significantly modulate overt emotion salience despite minimal systemic exposure. PMID:28534875

Dose-dependent social-cognitive effects of intranasal oxytocin delivered with novel Breath Powered device in adults with autism spectrum disorder: a randomized placebo-controlled double-blind crossover trial.

PubMed

Quintana, D S; Westlye, L T; Hope, S; Nærland, T; Elvsåshagen, T; Dørum, E; Rustan, Ø; Valstad, M; Rezvaya, L; Lishaugen, H; Stensønes, E; Yaqub, S; Smerud, K T; Mahmoud, R A; Djupesland, P G; Andreassen, O A

2017-05-23

The neuropeptide oxytocin has shown promise as a treatment for symptoms of autism spectrum disorders (ASD). However, clinical research progress has been hampered by a poor understanding of oxytocin's dose-response and sub-optimal intranasal delivery methods. We examined two doses of oxytocin delivered using a novel Breath Powered intranasal delivery device designed to improve direct nose-to-brain activity in a double-blind, crossover, randomized, placebo-controlled trial. In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks. We observed an omnibus main effect of treatment on the primary outcome measure of overt emotion salience as measured by emotional ratings of faces (η 2 =0.18). Compared to placebo, 8IU treatment increased overt emotion salience (P=0.02, d=0.63). There was no statistically significant increase after 24IU treatment (P=0.12, d=0.4). The effects after 8IU oxytocin were observed despite no significant increase in peripheral blood plasma oxytocin concentrations. We found no significant effects for reading the mind in the eyes task performance or secondary outcome social-cognitive tasks (emotional dot probe and face-morphing). To our knowledge, this is the first trial to assess the dose-dependent effects of a single oxytocin administration in autism, with results indicating that a low dose of oxytocin can significantly modulate overt emotion salience despite minimal systemic exposure.

Non-surgical interventions for convergence insufficiency

PubMed Central

Scheiman, Mitchell; Gwiazda, Jane; Li, Tianjing

2014-01-01

Background Convergence insufficiency is a common eye muscle co-ordination problem in which the eyes have a strong tendency to drift outward (exophoria) when reading or doing close work. Symptoms may include eye strain, headaches, double vision, print moving on the page, frequent loss of place when reading, inability to concentrate, and short attention span. Objectives To systematically assess and synthesize evidence from randomized controlled trials (RCTs) on the effectiveness of non-surgical interventions for convergence insufficiency. Search strategy We searched The Cochrane Library, MEDLINE, EMBASE, Science Citation Index, the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov) on 7 October 2010. We manually searched reference lists and optometric journals. Selection criteria We included RCTs examining any form of non-surgical intervention against placebo, no treatment, sham treatment, or each other. Data collection and analysis Two authors independently assessed eligibility, risk of bias, and extracted data. We performed meta-analyses when appropriate. Main results We included six trials (three in children, three in adults) with a total of 475 participants. We graded four trials at low risk of bias. Evidence from one trial (graded at low risk of bias) suggests that base-in prism reading glasses was no more effective than placebo reading glasses in improving clinical signs or symptoms in children. Evidence from one trial (graded at high risk of bias) suggests that base-in prism glasses using a progressive addition lens design was more effective than progressive addition lens alone in decreasing symptoms in adults. At three weeks of therapy, the mean difference in Convergence Insufficiency Symptoms Survey (CISS) score was −10.24 points (95% confidence interval (CI) −15.45 to −5.03). Evidence from two trials (graded at low risk of bias) suggests that outpatient (or office-based as used in the US) vision therapy/orthoptics was more effective than home-based convergence exercises (or pencil push-ups as used in the US) in children. At 12 weeks of therapy, the mean difference in change in near point of convergence, positive fusional vergence, and CISS score from baseline was 3.99 cm (95% CI 2.11 to 5.86), 13.13 diopters (95% CI 9.91 to 16.35), and 9.86 points (95% CI 6.70 to 13.02), respectively. In a young adult population, evidence from one trial (graded at low risk of bias) suggests outpatient vision therapy/orthoptics was more effective than home-based convergence exercises in improving positive fusional vergence at near (7.7 diopters, 95% CI 0.82 to 14.58), but not the other outcomes. Evidence from one trial (graded at low risk of bias) comparing four interventions, also suggests that outpatient vision therapy/orthoptics was more effective than home-based computer vision therapy/orthoptics in children. At 12 weeks, the mean difference in change in near point of convergence, positive fusional vergence, and CISS score from baseline was 2.90 cm (95% CI 0.96 to 4.84), 7.70 diopters (95% CI 3.94 to 11.46), and 8.80 points (95% CI 5.26 to 12.34), respectively. Evidence was less consistent for other pair-wise comparisons. Authors’ conclusions Current research suggests that outpatient vision therapy/orthoptics is more effective than home-based convergence exercises or home-based computer vision therapy/orthoptics for children. In adult population, evidence of the effectiveness of various non-surgical interventions is less consistent. PMID:21412896

Comparative Evaluation of Effect of Nano-hydroxyapatite and 8% Arginine Containing Toothpastes in Managing Dentin Hypersensitivity: Double Blind Randomized Clinical Trial.

PubMed

Anand, Suresh; Rejula, Fathima; Sam, Joseph V G; Christaline, Ramakrishnan; Nair, Mali G; Dinakaran, Shiji

This double blind randomized clinical trial was conducted with the purpose of evaluating the effects of Nano-hydroxyapatite toothpaste as compared to 8% Arginine containing toothpaste in the management of Dentin hypersensitivity (DH). Patients (30 in each group) suffering from DH and eliciting a VAS score higher than 2 in air blast and tactile test were randomly allocated (block randomization) into either a group 1 (arginine toothpaste) or group 2 (nHA toothpaste). The primary outcome evaluated was the reduction of DH as measured by the electrical stimulus reading on the digital pulp tester. Current required for eliciting a VAS score of 2 was recorded before application of dentifrice. 1 cm of toothpaste was then expressed on the tooth surface for two minutes in each group and rinsed off. The electrical stimulus required to elicit a VAS score of 2 was recorded after 5 minutes, 1 week and 4 weeks. The desensitizing paste containing arginine provided a statistically significant reduction in DH and so did the paste containing nHA. Mean increase in amperage value (reduction in DH) was higher for nHA based than the arginine containing dentifrice. This difference was not statistically significant showing that both toothpastes are equally effective. The findings of the present study encourage the use of Nano-hydroxyapatite and arginine containing dentifrice as an effective desensitizing agent providing relief from symptoms 5 minutes after application and after 1 and 4 weeks.

Community-based peer-led diabetes self-management: a randomized trial.

PubMed

Lorig, Kate; Ritter, Philip L; Villa, Frank J; Armas, Jean

2009-01-01

The purpose of this study is to determine the effectiveness of a community-based diabetes self-management program comparing treatment participants to a randomized usual-care control group at 6 months. A total of 345 adults with type 2 diabetes but no criteria for high A1C were randomized to a usual-care control group or 6-week community-based, peer-led diabetes self-management program (DSMP). Randomized participants were compared at 6 months. The DSMP intervention participants were followed for an additional 6 months (12 months total). A1C and body mass index were measured at baseline, 6 months, and 12 months. All other data were collected by self-administered questionnaires. At 6 months, DSMP participants did not demonstrate improvements in A1C as compared with controls. Baseline A1C was much lower than in similar trials. Participants did have significant improvements in depression, symptoms of hypoglycemia, communication with physicians, healthy eating, and reading food labels (P < .01). They also had significant improvements in patient activation and self-efficacy. At 12 months, DSMP intervention participants continued to demonstrate improvements in depression, communication with physicians, healthy eating, patient activation, and self-efficacy (P < .01). There were no significant changes in utilization measures. These findings suggest that people with diabetes without elevated A1C can benefit from a community-based, peer-led diabetes program. Given the large number of people with diabetes and lack of low-cost diabetes education, the DSMP deserves consideration for implementation.

Developmental Changes in the Visual Span for Reading

PubMed Central

Kwon, MiYoung; Legge, Gordon E.; Dubbels, Brock R.

2007-01-01

The visual span for reading refers to the range of letters, formatted as in text, that can be recognized reliably without moving the eyes. It is likely that the size of the visual span is determined primarily by characteristics of early visual processing. It has been hypothesized that the size of the visual span imposes a fundamental limit on reading speed (Legge, Mansfield, & Chung, 2001). The goal of the present study was to investigate developmental changes in the size of the visual span in school-age children, and the potential impact of these changes on children’s reading speed. The study design included groups of 10 children in 3rd, 5th, and 7th grade, and 10 adults. Visual span profiles were measured by asking participants to recognize letters in trigrams (random strings of three letters) flashed for 100 ms at varying letter positions left and right of the fixation point. Two print sizes (0.25° and 1.0°) were used. Over a block of trials, a profile was built up showing letter recognition accuracy (% correct) versus letter position. The area under this profile was defined to be the size of the visual span. Reading speed was measured in two ways: with Rapid Serial Visual Presentation (RSVP) and with short blocks of text (termed Flashcard presentation). Consistent with our prediction, we found that the size of the visual span increased linearly with grade level and it was significantly correlated with reading speed for both presentation methods. Regression analysis using the size of the visual span as a predictor indicated that 34% to 52% of variability in reading speeds can be accounted for by the size of the visual span. These findings are consistent with a significant role of early visual processing in the development of reading skills. PMID:17845810

Reading from an iPad or from a book in bed: the impact on human sleep. A randomized controlled crossover trial.

PubMed

Grønli, Janne; Byrkjedal, Ida Kristiansen; Bjorvatn, Bjørn; Nødtvedt, Øystein; Hamre, Børge; Pallesen, Ståle

2016-05-01

To objectively and subjectively compare whether reading a story for 30 min from an iPad or from a book in bed prior to sleep will differentially affect sleep. Sixteen students (12 females, mean age 25.1 ± 2.9 years) underwent ambulatory (sleeping in their own beds at home) polysomnographic (PSG) recordings in a counterbalanced crossover design consisting of three PSG nights (one adaptation night, two test nights) and two different reading materials: read from an iPad or from a book. Illumination was measured during reading and Karolinska Sleepiness Scale was completed prior to turning the light off. Sleep diaries were kept to assess subjective sleep parameters from day to day. Illumination was higher in the iPad condition compared to the book condition (58.3 ± 6.9 vs 26.7 ± 8.0 lux, p <0.001). Reading a story from an iPad decreased subjective sleepiness, delayed the EEG dynamics of slow wave activity by approximately 30 min, and reduced slow wave activity after sleep onset compared to reading from a book. No parameters of sleep state timing and sleep onset latency differed between the two reading conditions. Although there was no direct effect on time spent in different sleep states and self-reported sleep onset latency, the use of an iPad which emits blue enriched light impinges acutely on sleepiness and EEG characteristics of sleep pressure. Hence, the use of commercially available tablets may have consequences in terms of alertness, circadian physiology, and sleep. Published by Elsevier B.V.

Acquiring Science and Social Studies Knowledge in Kindergarten Through Fourth Grade: Conceptualization, Design, Implementation, and Efficacy Testing of Content-Area Literacy Instruction (CALI)

PubMed Central

Dombek, Jennifer; Crowe, Elizabeth C.; Spencer, Mercedes; Tighe, Elizabeth L.; Coffinger, Sean; Zargar, Elham; Wood, Taffeta; Petscher, Yaacov

2016-01-01

With national focus on reading and math achievement, science and social studies have received less instructional time. Yet, accumulating evidence suggests that content knowledge is an important predictor of proficient reading. Starting with a design study, we developed Content Area Literacy Instruction (CALI), as an individualized (or personalized) instructional program for kindergarteners through fourth graders to build science and social studies knowledge. We developed CALI to be implemented in general education classrooms, over multiple iterations (n=230 students), using principles of design-based implementation research. The aims were to develop CALI as a usable and feasible instructional program that would, potentially, improve science and social studies knowledge, and could be implemented during the literacy block without negatively affecting students' reading gains (i.e., no opportunity cost). We then evaluated the efficacy of CALI in a randomized controlled field trial with 418 students in kindergarten through fourth grade. Results reveal that CALI demonstrates promise as a useable and feasible instructional individualized general education program, and is efficacious in improving social studies (d=2.2) and science (d=2.1) knowledge, with some evidence of improving oral and reading comprehension skills (d=.125). PMID:28479610

Quality and Utility: The 1994 Trial State Assessment in Reading. The Fourth Report of the National Academy of Education Panel on the Evaluation of the NAEP Trial State Assessment: 1994 Trial State Assessment in Reading.

ERIC Educational Resources Information Center

National Academy of Education, Stanford, CA.

This report evaluates the conduct, validity, and uses of the National Assessment of Educational Progress (NAEP) Trial State Assessment (TSA). The report addresses such pressing problems as how participation in NAEP can be maintained and appropriate samples can be achieved; how errors can be minimized in the complex process of scaling and analyzing…

The effectiveness of a serious game to enhance empathy for care workers for people with disabilities: A parallel randomized controlled trial.

PubMed

Sterkenburg, P S; Vacaru, V S

2018-04-04

Empathic care is fundamental in healthcare settings and is associated to several positive outcomes for care workers (i.e. burnout, compassion satisfaction) and patients (i.e. therapeutic alliance, trust, wellbeing). Yet, studies showed a decrease in empathy in care workers, which is argued to be a product of personal distress. Thus, interventions should aim at enhancing empathy in care workers working for vulnerable populations to ensure optimal client-carer relationships. The current study investigates the effectiveness of the serious game "The world of EMPA" in enhancing empathy in care workers for people with disabilities, and tests the effect of personal distress on empathy change post intervention. We conducted a superiority parallel randomized controlled trial (RCT) and tested 224 participants in two conditions: the experimental group (n = 111) played a serious game and the control group (n = 113) read a digital information package about disabilities. Participants were assessed on empathy and personal distress prior to and after the intervention. Main results showed that the serious game did not significantly enhance empathy in care workers, whereas reading a digital information package yield a significant decrease in empathy. Exploratory analysis showed that the serious game decreased significantly personal distress in care-workers. This study showed that while the serious game "The world of EMPA" did not enhance empathy, it resulted in a decrease in personal distress in care workers for people with disabilities. Further evidence should corroborate these findings to unveil the mechanisms of this intervention and the long-term effects on personal distress. Copyright © 2018 Elsevier Inc. All rights reserved.

A randomized controlled trial comparing 2 interventions for visual field loss with standard occupational therapy during inpatient stroke rehabilitation.

PubMed

Mödden, Claudia; Behrens, Marion; Damke, Iris; Eilers, Norbert; Kastrup, Andreas; Hildebrandt, Helmut

2012-06-01

Compensatory and restorative treatments have been developed to improve visual field defects after stroke. However, no controlled trials have compared these interventions with standard occupational therapy (OT). A total of 45 stroke participants with visual field defect admitted for inpatient rehabilitation were randomized to restorative computerized training (RT) using computer-based stimulation of border areas of their visual field defects or to a computer-based compensatory therapy (CT) teaching a visual search strategy. OT, in which different compensation strategies were used to train for activities of daily living, served as standard treatment for the active control group. Each treatment group received 15 single sessions of 30 minutes distributed over 3 weeks. The primary outcome measures were visual field expansion for RT, visual search performance for CT, and reading performance for both treatments. Visual conjunction search, alertness, and the Barthel Index were secondary outcomes. Compared with OT, CT resulted in a better visual search performance, and RT did not result in a larger expansion of the visual field. Intragroup pre-post comparisons demonstrated that CT improved all defined outcome parameters and RT several, whereas OT only improved one. CT improved functional deficits after visual field loss compared with standard OT and may be the intervention of choice during inpatient rehabilitation. A larger trial that includes lesion location in the analysis is recommended.

Performance of Crohn's disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data.

PubMed

Feagan, Brian; Sandborn, William J; Rutgeerts, Paul; Levesque, Barrett G; Khanna, Reena; Huang, Bidan; Zhou, Qian; Maa, Jen-Fue; Wallace, Kori; Lacerda, Ana; Thakkar, Roopal B; Robinson, Anne M

2018-04-23

Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation. This post hoc analysis of data fromEXTEND (extend the safety and efficacy of adalimumab through endoscopic healing), a placebo (PBO)-controlled, randomized trial of adalimumab (ADA) for mucosal healing, included adults with moderate-to-severe CD. Subsets of patients meeting specified Simplified Endoscopic Score for CD (SES-CD) inclusion criteria, according to site or central reading, and baseline stool frequency (SF) and/or abdominal pain score (AP) thresholds were evaluated. Various endpoint definitions based on the Crohn's Disease Activity Index (CDAI), its SF and AP components, SES-CD, and composite endpoints were compared between treatment groups. Increased stringency of Week 12 clinical endpoints compared to CDAI<150 to SF≤3.0/1.5&AP≤1.0 reduced PBO response rates by ≥12% and increased treatment effects by ≤10%. Amending the SES-CD endpoint from ≤4 to ≤2 reduced the treatment effect from 24% to 8%. Composite endpoints further diminished response rates and effect sizes. Site-based evaluation was associated with lower remission rates versus central reading in the PBO group and, thus, greater ADA-related treatment effects. This analysis is the first to demonstrate that increasing the stringency of clinical and endoscopic endpoint definitions in CD trials, especially lowering SF or SES-CD definitions, reduces the ability to detect treatment-related change in CD activity; focus on endpoints that reflect clinical change is warranted.

Holistic word processing in dyslexia

PubMed Central

Conway, Aisling; Misra, Karuna

2017-01-01

People with dyslexia have difficulty learning to read and many lack fluent word recognition as adults. In a novel task that borrows elements of the ‘word superiority’ and ‘word inversion’ paradigms, we investigate whether holistic word recognition is impaired in dyslexia. In Experiment 1 students with dyslexia and controls judged the similarity of pairs of 6- and 7-letter words or pairs of words whose letters had been partially jumbled. The stimuli were presented in both upright and inverted form with orthographic regularity and orientation randomized from trial to trial. While both groups showed sensitivity to orthographic regularity, both word inversion and letter jumbling were more detrimental to skilled than dyslexic readers supporting the idea that the latter may read in a more analytic fashion. Experiment 2 employed the same task but using shorter, 4- and 5-letter words and a design where orthographic regularity and stimuli orientation was held constant within experimental blocks to encourage the use of either holistic or analytic processing. While there was no difference in reaction time between the dyslexic and control groups for inverted stimuli, the students with dyslexia were significantly slower than controls for upright stimuli. These findings suggest that holistic word recognition, which is largely based on the detection of orthographic regularity, is impaired in dyslexia. PMID:29121046

A Comparison of Seventh Grade Thai Students' Reading Comprehension and Motivation to Read English through Applied Instruction Based on the Genre-Based Approach and the Teacher's Manual

ERIC Educational Resources Information Center

Sawangsamutchai, Yutthasak; Rattanavich, Saowalak

2016-01-01

The objective of this research is to compare the English reading comprehension and motivation to read of seventh grade Thai students taught with applied instruction through the genre-based approach and teachers' manual. A randomized pre-test post-test control group design was used through the cluster random sampling technique. The data were…

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders: study protocol for a randomized controlled trial.

PubMed

Kuroda, Miho; Kawakubo, Yuki; Kuwabara, Hitoshi; Yokoyama, Kazuhito; Kano, Yukiko; Kamio, Yoko

2013-07-23

Adults with high-functioning autism spectrum disorders (ASD) have difficulties in social communication; thus, these individuals have trouble understanding the mental states of others. Recent research also suggests that adults with ASD are unable to understand their own mental states, which could lead to difficulties in emotion-regulation. Some studies have reported the efficacy of cognitive-behavioral therapy (CBT) in improving emotion-regulation among children with ASD. The current study will investigate the efficacy of group-based CBT for adults with ASD. The study is a randomized, waitlist controlled, single-blinded trial. The participants will be 60 adults with ASD; 30 will be assigned to a CBT group and 30 to a waitlist control group. Primary outcome measures are the 20-item Toronto Alexithymia Scale, the Coping Inventory for Stressful Situations, the Motion Picture Mind-Reading task, and an ASD questionnaire. The secondary outcome measures are the Center for Epidemiological Studies Depression Scale, the World Health Organization Quality of Life Scale 26-item version, the Global Assessment of Functioning, State-trait Anxiety Inventory, Social Phobia and Anxiety Inventory, and Liebowitz Social Anxiety Scale. All will be administered during the pre- and post-intervention, and 12 week follow-up periods. The CBT group will receive group therapy over an 8 week period (one session per week) with each session lasting approximately 100 minutes. Group therapy will consist of four or five adults with ASD and two psychologists. We will be using visual materials for this program, mainly the Cognitive Affective Training kit. This trial will hopefully indicate the efficacy of group-based CBT for adults with high- functioning ASD. This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry No. UMIN000006236.

Histamine Antagonists for Treatment of Peripheral Vertigo: A Meta-Analysis.

PubMed

Amini, Afshin; Heidari, Kamran; Kariman, Hamid; Taghizadeh, Mehrdad; Hatamabadi, Hamidreza; Shahrami, Ali; Derakhshanfar, Hojat; Asadollahi, Shadi

2015-08-01

Vertigo, the hallucination of movement of oneself or one's surroundings, can have substantial adverse effects on the quality of life of affected patients. It is essential to decrease the frequency, severity, and duration of vertigo attacks using effective medications with minimal debilitating adverse effects. We performed a meta-analysis of available clinical trials to evaluate the efficacy of histamine antagonists in the treatment of vertigo compared to the rate of resolution in untreated control groups. A systematic search of articles in any language from January 1970 to March 2015 was performed through the following databases: the Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, the Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Health Sciences Literature, Allied and Complementary Medicine Database, Web of Science, ClinicalTrials.gov, and Google. Randomized controlled trials comparing each kind of antihistamine to untreated control participants in the treatment of vertigo (blinded/unblinded) were screened for inclusion. Three reviewers separately performed data extraction from the included trials using a standard data abstraction form. Three other researchers read the final list of all articles retained. Discrepancies were settled by mutual consensus between the authors. Random effects models were applied to estimate the pooled odds ratio (OR) and 95% confidence interval (CI) using the Review Manager software. The evaluation of publication bias was performed by Egger's test and Begg's funnel plot. We identified 13 eligible citations. The pooled OR was 5.370, 95% CI (3.263-8.839), and I2=56.0%, with no obvious evidence of publication bias. Our results provide clarification of the effectiveness of several categories of histamine antagonists compared with placebos in controlling peripheral vertigo.

Randomized controlled trial on the effects of CCTV training on quality of life, depression, and adaptation to vision loss.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Knol, Dirk L; Ringens, Peter J; van Rens, Ger H M B

2012-06-14

In addition to performance-based measures, vision-related quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of training in the use of closed-circuit televisions (CCTV) were investigated. Patients (n = 122) were randomized either to a treatment group that received usual delivery instructions from the supplier combined with concise outpatient training, or to a control group that received delivery instructions only. Subjective outcomes were the low vision quality-of-life questionnaire (LVQOL), EuroQOL 5 dimensions, adaptation to age-related vision loss (AVL), and the Center of Epidemiologic Studies Depression scales. Linear mixed models were used to investigate treatment effects. Differential effects of patient characteristics were studied by implementing higher order interactions into the models. From baseline to follow-up, all patients perceived significantly less problems on the reading and fine work dimension (-28.8 points; P < 0.001) and the adaptation dimension (-4.67 points; P = 0.04) of the LVQOL. However, no treatment effect was found based on the intention-to-treat analysis. This study demonstrated the effect of receiving and using a CCTV on two vision-related QOL dimensions; however, outpatient training in the use of CCTVs had no additional value. (trialregister.nl number, NTR1031.).

Reach Out Churches: A Community-Based Participatory Research Pilot Trial to Assess the Feasibility of a Mobile Health Technology Intervention to Reduce Blood Pressure Among African Americans.

PubMed

Skolarus, Lesli E; Cowdery, Joan; Dome, Mackenzie; Bailey, Sarah; Baek, Jonggyu; Byrd, James Brian; Hartley, Sarah E; Valley, Staci C; Saberi, Sima; Wheeler, Natalie C; McDermott, Mollie; Hughes, Rebecca; Shanmugasundaram, Krithika; Morgenstern, Lewis B; Brown, Devin L

2017-06-01

Innovative strategies are needed to reduce the hypertension epidemic among African Americans. Reach Out was a faith-collaborative, mobile health, randomized, pilot intervention trial of four mobile health components to reduce high blood pressure (BP) compared to usual care. It was designed and tested within a community-based participatory research framework among African Americans recruited and randomized from churches in Flint, Michigan. The purpose of this pilot study was to assess the feasibility of the Reach Out processes. Feasibility was assessed by willingness to consent (acceptance of randomization), proportion of weeks participants texted their BP readings (intervention use), number lost to follow-up (retention), and responses to postintervention surveys and focus groups (acceptance of intervention). Of the 425 church members who underwent BP screening, 94 enrolled in the study and 73 (78%) completed the 6-month outcome assessment. Median age was 58 years, and 79% were women. Participants responded with their BPs on an average of 13.7 (SD = 10.7) weeks out of 26 weeks that the BP prompts were sent. All participants reported satisfaction with the intervention. Reach Out, a faith-collaborative, mobile health intervention was feasible. Further study of the efficacy of the intervention and additional mobile health strategies should be considered.

Effect of NICU Department Orientation Program on Mother’s Anxiety: a Randomized Clinical Trial

PubMed Central

Valizadeh, Leila; Hosseini, Mohammad Bager; Heydarpoor Damanabad, Zhilla; Rahkar Farshi, Mahni; Asgari Jafarabadi, Mohammad; Ranjbar Kochaksaraie, Fatemeh

2016-01-01

Introduction: Neonatal intensive care unit induces the high level of anxiety for mothers. The aim of this study was to evaluate the effectiveness of NICU orientation program on the anxiety of mothers who had preterm newborns hospitalized in NICU. Methods: This study was a randomized clinical trial (three parallel groups). Participants included 99 mothers with preterm newborns hospitalized in NICU of Al- Zahra hospital, affiliated to Tabriz University of Medical Sciences in 2015. Mothers were randomly assigned to one of three groups (film, booklet, and control). Mothers completed the State- Trait Anxiety Inventory before entering to the NICU, and then mothers in the experiment groups became familiar with the NICU environment through watching a film or reading booklet. After the first NICU visit, all mothers completed the STAI and Cattell's Anxiety Questionnaires. Data were analyzed using SPSS ver. 13 software. Results: There was no significant difference between three groups regarding state- trait anxiety before the intervention. After the first NICU visit, a significant reduction in maternal state anxiety was seen in the both experiment groups. There was no statistical significant difference regarding trait anxiety. Data obtained from Cattell's anxiety questionnaire after intervention, showed significant difference in state anxiety between groups. Conclusion: Employing film and booklet orientation strategy after preterm delivery can reduce the mother’s anxiety and beneficent for the mother, baby, family and health care system. PMID:27752486

A randomized trial examining the effects of parent engagement on early language and literacy: the Getting Ready intervention.

PubMed

Sheridan, Susan M; Knoche, Lisa L; Kupzyk, Kevin A; Edwards, Carolyn Pope; Marvin, Christine A

2011-06-01

Language and literacy skills established during early childhood are critical for later school success. Parental engagement with children has been linked to a number of adaptive characteristics in preschoolers including language and literacy development, and family-school collaboration is an important contributor to school readiness. This study reports the results of a randomized trial of a parent engagement intervention designed to facilitate school readiness among disadvantaged preschool children, with a particular focus on language and literacy development. Participants included 217 children, 211 parents, and 29 Head Start teachers in 21 schools. Statistically significant differences in favor of the treatment group were observed between treatment and control participants in the rate of change over 2 academic years on teacher reports of children's language use (d=1.11), reading (d=1.25), and writing skills (d=0.93). Significant intervention effects on children's direct measures of expressive language were identified for a subgroup of cases where there were concerns about a child's development upon entry into preschool. Additionally, other child and family moderators revealed specific variables that influenced the treatment's effects. Copyright © 2011 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

A Randomized Trial Examining the Effects of Parent Engagement on Early Language and Literacy: The Getting Ready Intervention

PubMed Central

Knoche, Lisa L.; Kupzyk, Kevin A.; Edwards, Carolyn Pope; Marvin, Christine A.

2011-01-01

Language and literacy skills established during early childhood are critical for later school success. Parental engagement with children has been linked to a number of adaptive characteristics in preschoolers including language and literacy development, and family-school collaboration is an important contributor to school readiness. This study reports the results of a randomized trial of a parent engagement intervention designed to facilitate school readiness among disadvantaged preschool children, with a particular focus on language and literacy development. Participants included 217 children, 211 parents, and 29 Head Start teachers in 21 schools. Statistically significant differences in favor of the treatment group were observed between treatment and control participants in the rate of change over 2 academic years on teacher reports of children’s language use (d = 1.11), reading (d = 1.25), and writing skills (d = .93). Significant intervention effects on children’s direct measures of expressive language were identified for a subgroup of cases where there were concerns about a child’s development upon entry into preschool. Additionally, other child and family moderators revealed specific variables that influenced the treatment’s effects. PMID:21640249

A randomized control trial of interventions in school-aged children with auditory processing disorders.

PubMed

Sharma, Mridula; Purdy, Suzanne C; Kelly, Andrea S

2012-07-01

The primary purpose of the study was to compare intervention approaches for children with auditory processing disorder (APD): bottom-up training including activities focused on auditory perception, discrimination, and phonological awareness, and top-down training including a range of language activities. Another purpose was to determine the benefits of personal FM systems. The study is a randomized control trial where participants were allocated to groups receiving one of the two interventions, with and without personal FM, or to the no intervention group. The six-week intervention included weekly one-hour sessions with a therapist in the clinic, plus 1-2 hours per week of parent-directed homework. 55 children (7 to 13 years) with APD participated in the study. Intervention outcomes included reading, language, and auditory processing. Positive outcomes were observed for both training approaches and personal FM systems on several measures. Pre-intervention nonverbal IQ, age, and severity of APD did not influence outcomes. Performance of control group participants did not change when retested after the intervention period. Both intervention approaches were beneficial and there were additional benefits with the use of personal FM. Positive results were not limited to the areas specifically targeted by the interventions.

"Mississippi Trial, 1955": Tangling with Text through Reading, Discussion, and Writing

ERIC Educational Resources Information Center

Grierson, Sirpa; Thursby, Jacqueline S.; Dean, Deborah; Crowe, Chris

2007-01-01

The authors proffer practical critical-reading strategies for teaching "Mississippi Trial, 1955" to increase students' vocabulary, comprehension, and background knowledge of historical eras. They use nonfiction, a PBS documentary, the Web, folklore, and picture books among other tools for inciting thoughtful discussion and writing.

A longitudinal cluster-randomized controlled study on the accumulating effects of individualized literacy instruction on students' reading from first through third grade.

PubMed

Connor, Carol McDonald; Morrison, Frederick J; Fishman, Barry; Crowe, Elizabeth C; Al Otaiba, Stephanie; Schatschneider, Christopher

2013-08-01

Using a longitudinal cluster-randomized controlled design, we examined whether students' reading outcomes differed when they received 1, 2, or 3 years of individualized reading instruction from first through third grade, compared with a treated control group. More than 45% of students came from families living in poverty. Following students, we randomly assigned their teachers each year to deliver individualized reading instruction or a treated control condition intervention focused on mathematics. Students who received individualized reading instruction in all three grades showed the strongest reading skills by the end of third grade compared with those who received fewer years of such instruction. There was inconsistent evidence supporting a sustained first-grade treatment effect: Individualized instruction in first grade was necessary but not sufficient for stronger third-grade reading outcomes. These effects were achieved by regular classroom teachers who received professional development, which indicates that policies that support the use of evidence-based reading instruction and teacher training can yield increased student achievement.

The Minimalist Reading Model: Rethinking Reading Lists in Arts and Education Subjects

ERIC Educational Resources Information Center

Piscioneri, Matthew; Hlavac, Jim

2013-01-01

Despite reading being recognized as a core academic skill, surprisingly little research has been undertaken into university lecture reading requirements. This article reports on the trial and evaluation of a minimalist reading model developed for students in arts and education subjects. Comprising annotated extracts from full texts…

Current Readings: Single Versus Bilateral Internal Mammary Artery in Coronary Artery Bypass Grafting.

PubMed

Ejiofor, Julius I; Kaneko, Tsuyoshi; Aranki, Sary F

2018-06-24

There is strong retrospective data demonstrating that BIMA grafting leads to better long-term survival as compared to LIMA grafting. However, this survival advantage was not corroborated by the interim results of the Arterial Revascularization Trial(ART). Today, there are barriers to widespread adoption of BIMA grafting. One of the main disadvantages of the use of BIMA grafts is the higher risk of DSWI. Deep sternal wound infections can be minimized by skeletonized harvesting of the IMA grafts, which preserves blood flow to the sternum. Also, utilizing the BIMA graft as a "Y" graft may lead to more complete revascularization compared to its in-situ use. BIMA grafting on average takes 25 minutes longer operating time with a higher in-hospital costs. We eagerly await the 10-year results of the ART trial to determine the truly unbiased randomized long-term effectiveness of BIMA grafting. Copyright © 2018 Elsevier Ltd. All rights reserved.

Cognitive rehabilitation with right hemifield eye-patching for patients with sub-acute stroke and visuo-spatial neglect: a randomized controlled trial.

PubMed

Aparicio-López, Celeste; García-Molina, Alberto; García-Fernández, Juan; Lopez-Blazquez, Raquel; Enseñat-Cantallops, Antonia; Sánchez-Carrión, Rocío; Muriel, Vega; Tormos, Jose María; Roig-Rovira, Teresa

2015-01-01

To assess whether, following a right-hemisphere stroke, the combined administration of computer-based cognitive rehabilitation and right hemifield eye-patching in patients with visuo-spatial neglect is more effective than computer-based cognitive rehabilitation alone. Twelve patients were randomized into two treatment groups: a single treatment group (n = 7) and a combination treatment group (n = 5). In both cases, the treatment consisted of a mean number of 15 sessions, each lasting 1 hour. Visuo-spatial neglect was assessed using a specific exploration protocol (Bell Cancellation Test, Figure Copying of Odgen, Line Bisection, Baking Tray Task and Reading Task). The functional effects of the treatment were assessed using the Catherine Bergego Scale. Significant between-group differences were observed when comparing the pre- and post-treatment scores for the Reading Task. No differences were observed in either group in the Catherine Bergego Scale administered at baseline and at the final intervention. The results obtained do not allow one to conclude that the combination treatment with cognitive rehabilitation and right hemifield eye-patching is more effective than cognitive rehabilitation alone. Although partial improvement in the performance of neuropsychological tests was observed, this improvement is not present at functional level.

Preliminary validation of 2 magnetic resonance image scoring systems for osteoarthritis of the hip according to the OMERACT filter.

PubMed

Maksymowych, Walter P; Cibere, Jolanda; Loeuille, Damien; Weber, Ulrich; Zubler, Veronika; Roemer, Frank W; Jaremko, Jacob L; Sayre, Eric C; Lambert, Robert G W

2014-02-01

Development of a validated magnetic resonance image (MRI) scoring system is essential in hip OA because radiographs are insensitive to change. We assessed the feasibility and reliability of 2 previously developed scoring methods: (1) the Hip Inflammation MRI Scoring System (HIMRISS) and (2) the Hip Osteoarthritis MRI Scoring System (HOAMS). Six readers (3 radiologists, 3 rheumatologists) participated in 2 reading exercises. In Reading Exercise 1, MRI of the hip of 20 subjects were read at a single time point followed by further standardization of methodology. In Reading Exercise 2, MRI of the hip of 18 subjects from a randomized controlled trial, assessed at 2 timepoints, and 27 subjects from a cross-sectional study were read for HIMRISS and HOAMS bone marrow lesions (BML) and synovitis. Reliability was assessed using intraclass correlation coefficient (ICC) and kappa statistics. Both methods were considered feasible. For Reading 1, HIMRISS ICC were 0.52, 0.61, 0.70, and 0.58 for femoral BML, acetabular BML, effusion, and total scores, respectively; and for HOAMS, summed BML and synovitis ICC were 0.52 and 0.46, respectively. For Reading 2, HIMRISS and HOAMS ICC for BML and synovitis-effusion improved substantially. Interobserver reliability for change scores was 0.81 and 0.71 for HIMRISS femoral and HOAMS summed BML, respectively. Responsiveness and discrimination was moderate to high for synovitis-effusion. Significant associations were noted between BML or synovitis scores and Western Ontario and McMaster Universities Osteoarthritis Index pain scores for baseline values (p ≤ 0.001). The BML and synovitis-effusion components of both HIMRISS and HOAMS scoring systems are feasible and reliable, and should be validated further.

Effects of Differentiated Reading on Elementary Students' Reading Comprehension and Attitudes toward Reading

ERIC Educational Resources Information Center

Shaunessy-Dedrick, Elizabeth; Evans, Linda; Ferron, John; Lindo, Myriam

2015-01-01

In this investigation, we examined the effects of a differentiated reading approach on fourth grade students' reading comprehension and attitudes toward reading. Eight Title I schools within one urban district were randomly assigned to treatment (Schoolwide Enrichment Model-Reading [SEM-R]) or control (district reading curriculum) conditions.…

Changing case Order to Optimise patterns of Performance in mammography Screening (CO-OPS): study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background X-ray mammography remains the predominant test for screening for breast cancer, with the aim of reducing breast cancer mortality. In the English NHS Breast Screening Programme each woman’s mammograms are examined separately by two expert readers. The two readers read each batch in the same order and each indicates if there should be recall for further tests. This is a highly skilled, pressurised, repetitive and frequently intellectually unchallenging activity where readers examine one or more batches of 30–50 women’s mammograms in each session. A vigilance decrement or performance decrease over time has been observed in similar repetitive visual tasks such as radar operation. Methods/Design The CO-OPS study is a pragmatic, multi-centre, two-arm, double blind cluster randomised controlled trial of a computer software intervention designed to reduce the effects of a vigilance decrement in breast cancer screening. The unit of randomisation is the batch. Intervention batches will be examined in the opposite order by the two readers (one forwards, one backwards). Control batches will be read in the same order as one another, as is current standard practice. The hypothesis is that cancer detection rates will be higher in the intervention group because each readers’ peak performance will occur when examining different women’s mammograms. The trial will take place in 44 English breast screening centres for 1 year and 4 months. The primary outcome is cancer detection rate, which will be extracted from computer records after 1 year of the trial. The secondary outcomes include rate of disagreement between readers (a more statistically powerful surrogate for cancer detection rate), recall rate, positive predictive value, and interval cancer rate (cancers found between screening rounds which will be measured three years after the end of the trial). Discussion This is the first trial of an intervention to ameliorate a vigilance decrement in breast cancer screening. Trial registration ISRCTN46603370 (submitted: 24 October 2012, date of registration: 26 March 2013). PMID:24411004

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

PubMed

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

2009-07-02

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

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

PubMed Central

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

2009-01-01

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

Evidence that monkeys (Macaca tonkeana and Sapajus apella) read moves, but no evidence that they read goals.

PubMed

Costes-Thiré, Morgane; Levé, Marine; Uhlrich, Pierre; Pasquaretta, Cristian; De Marco, Arianna; Thierry, Bernard

2015-08-01

Whereas most experiments indicate that monkeys have no theory of mind, a study carried out by Wood and collaborators (2007) claimed that they can make inferences about the intentions of another individual. We applied the experimental procedure devised by these authors to investigate whether monkeys can recognize goal-directed actions. We tested 16 Tonkean macaques (Macaca tonkeana) and 12 tufted capuchin monkeys (Sapajus apella). Each subject was submitted to 24 trials in randomized order. The experimenter presented 2 containers, 1 of which was potentially baited with a food reward. After the experimenter had either intentionally or accidentally made an action on 1 of the containers, the subject was asked to select 1 of them. We found that individuals in both species failed to distinguish between accidental and intentional actions. However, they displayed a significant preference for the container touched by the experimenter in the hand conditions, and not in the elbow conditions. These results do not support those reported by Wood and collaborators, but they are consistent with other studies concluding that monkeys are not capable of mind reading. (c) 2015 APA, all rights reserved).

Mobile access to virtual randomization for investigator-initiated trials.

PubMed

Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization becomes available for investigator-initiated trials and potentially for large multi-center trials.

Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

PubMed Central

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

2011-01-01

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

Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial.

PubMed

Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

2015-01-01

Regular physical activity is an important aspect of self-management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalized feedback (PF) or peer support (PS); and there was no study on older people of Asian heritage. Hence, this trial evaluated whether PF only or combined with PS improves physical activity among older Malays with type 2 diabetes (T2DM) compared to usual care only. A three-arm randomized controlled trial was conducted in a primary healthcare clinic in Malaysia. Sixty-nine sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomized to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life, and psychosocial wellbeing. Fifty-two (75.4%) completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p = 0.001). The PS group also had greater improvement in weekly duration (p < 0.001) and frequency (p < 0.001) of moderate intensity physical activity, scores on the Physical Activity Scale for Elderly (p = 0.003), 6-min walk test (p < 0.001), and social support from friends (p = 0.032) than PF and control groups. The findings suggest that PF combined with PS in older Malays with T2DM improved their physical activity levels, cardiorespiratory fitness, and support from friends. Current Controlled Trials ISRCTN71447000.

Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial

PubMed Central

Kerry, Sally M.; Markus, Hugh S.; Khong, Teck K.; Cloud, Geoffrey C.; Tulloch, Jenny; Coster, Denise; Ibison, Judith; Oakeshott, Pippa

2013-01-01

Background: Adequate control of blood pressure reduces the risk of recurrent stroke. We conducted a randomized controlled study to determine whether home blood pressure monitoring with nurse-led telephone support would reduce blood pressure in patients with hypertension and a history of stroke. Methods: We recruited 381 participants (mean age 72 years) from outpatient and inpatient stroke clinics between Mar. 1, 2007, and Aug. 31, 2009. Nearly half (45%, 170) of the participants had some disability due to stroke. Participants were visited at home for a baseline assessment and randomly allocated to home blood pressure monitoring (n = 187) or usual care (n = 194). Those in the intervention group were given a monitor, brief training and telephone support. Participants who had home blood pressure readings consistently over target (target < 130/80 mm Hg) were advised to consult their family physician. The main outcome measure was a fall in systolic blood pressure after 12 months, measured by an independent researcher unaware of group allocation. Results: Despite more patients in the intervention group than in the control group having changes to antihypertensive treatment during the trial period (60.1% [98/163] v. 47.6% [78/164], p = 0.02), the fall in systolic blood pressure from baseline did not differ significantly between the groups (adjusted mean difference 0.3 mm Hg, 95% confidence interval –3.6 to 4.2 mm Hg). Subgroup analysis showed significant interaction with disability due to stroke (p = 0.03 at 6 months) and baseline blood pressure (p = 0.03 at 12 months). Interpretation: Overall, home monitoring did not improve blood pressure control in patients with hypertension and a history of stroke. It was associated with a fall in systolic pressure in patients who had uncontrolled blood pressure at baseline and those without disability due to stroke. Trial registration: ClinicalTrials.gov registration NCT00514800 PMID:23128283

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

PubMed Central

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

2013-01-01

Background Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. Methods We conducted a double-blind (de facto masking) randomized controlled trial using a popular brain training game (Brain Age) and a popular puzzle game (Tetris). Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability). Results and Discussion Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed) in the healthy young adults. Conclusions Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields. Trial Registration UMIN Clinical Trial Registry 000005618. PMID:23405164

Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial

PubMed Central

2012-01-01

Background Cancer is one of the major health issues worldwide. An increasing number of cancer patients are offered treatment with surgery, chemotherapy and radiotherapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies offered to cancer patients in Taiwan. We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of TCM in patients with cancer. Methods/design In this study, inclusion criteria are postoperative patients with histologically confirmed cancer within 3 years who are undergoing chemotherapy or radiotherapy, more than 18 years old, have given signed informed consent, have the ability to read Chinese, and the ability for oral intake. Exclusion criteria include being pregnant, breast feeding, having completed chemotherapy or radiotherapy, brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four, delusion or hallucinations, acute infection, and have received medications under other clinical trials. The patients were separated into an intervention group (Shen-Mai-San, SMS) and a placebo group for four weeks using a randomized, double-blind procedure. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QOL-C30) was used to evaluate the quality of life. General data, hemoglobin (Hb), hematocrit (Hct), glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), blood urea nitrogen (BUN), creatinine, carcinoembryonic antigen (CEA), TCM diagnosis data and heart rate variability (HRV) were also recorded. These data were collected at baseline, two weeks and four weeks after receiving medication. The patients were prescribed granules which contained therapeutic medicines or placebo. Paired-T test was used for statistical analysis. Discussion Shen-Mai-San is composed of processed Ginseng radis, Liriope spicata, and Schizandrae fructus. It was found to be effective for treating cancer-related fatigue and had anti-fatigue activity. In TCM theory, SMS has a synergistic effect for qi and yin deficiency and has the ability to prevent fatigue. The symptoms of qi and yin deficiency are similar to chemotherapy- or radiotherapy-induced side effects. In order to evaluate the efficacy of SMS on cancer treatment, we designed a randomized, double-blind, placebo-controlled trial. Trial registration This study is registered to Clinical Trails.gov NCT01580358 PMID:23206440

Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial.

PubMed

Wong, Holly; Kaufman, Jaime; Baylis, Barry; Conly, John M; Hogan, David B; Stelfox, Henry T; Southern, Danielle A; Ghali, William A; Ho, Chester H

2015-09-29

Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers. A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups' interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge). This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers. ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).

Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

ERIC Educational Resources Information Center

Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

2014-01-01

Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

Effect of changing the amount and type of fat and carbohydrate on insulin sensitivity and cardiovascular risk: the RISCK (Reading, Imperial, Surrey, Cambridge, and Kings) trial1234

PubMed Central

Jebb, Susan A; Lovegrove, Julie A; Griffin, Bruce A; Frost, Gary S; Moore, Carmel S; Chatfield, Mark D; Bluck, Les J; Williams, Christine M; Sanders, Thomas AB

2010-01-01

Background: Insulin sensitivity (Si) is improved by weight loss and exercise, but the effects of the replacement of saturated fatty acids (SFAs) with monounsaturated fatty acids (MUFAs) or carbohydrates of high glycemic index (HGI) or low glycemic index (LGI) are uncertain. Objective: We conducted a dietary intervention trial to study these effects in participants at risk of developing metabolic syndrome. Design: We conducted a 5-center, parallel design, randomized controlled trial [RISCK (Reading, Imperial, Surrey, Cambridge, and Kings)]. The primary and secondary outcomes were changes in Si (measured by using an intravenous glucose tolerance test) and cardiovascular risk factors. Measurements were made after 4 wk of a high-SFA and HGI (HS/HGI) diet and after a 24-wk intervention with HS/HGI (reference), high-MUFA and HGI (HM/HGI), HM and LGI (HM/LGI), low-fat and HGI (LF/HGI), and LF and LGI (LF/LGI) diets. Results: We analyzed data for 548 of 720 participants who were randomly assigned to treatment. The median Si was 2.7 × 10−4 mL · μU−1 · min−1 (interquartile range: 2.0, 4.2 × 10−4 mL · μU−1 · min−1), and unadjusted mean percentage changes (95% CIs) after 24 wk treatment (P = 0.13) were as follows: for the HS/HGI group, −4% (−12.7%, 5.3%); for the HM/HGI group, 2.1% (−5.8%, 10.7%); for the HM/LGI group, −3.5% (−10.6%, 4.3%); for the LF/HGI group, −8.6% (−15.4%, −1.1%); and for the LF/LGI group, 9.9% (2.4%, 18.0%). Total cholesterol (TC), LDL cholesterol, and apolipoprotein B concentrations decreased with SFA reduction. Decreases in TC and LDL-cholesterol concentrations were greater with LGI. Fat reduction lowered HDL cholesterol and apolipoprotein A1 and B concentrations. Conclusions: This study did not support the hypothesis that isoenergetic replacement of SFAs with MUFAs or carbohydrates has a favorable effect on Si. Lowering GI enhanced reductions in TC and LDL-cholesterol concentrations in subjects, with tentative evidence of improvements in Si in the LF-treatment group. This trial was registered at clinicaltrials.gov as ISRCTN29111298. PMID:20739418

Easy-to-Read Informed Consent Forms for Hematopoietic Cell Transplantation Clinical Trials

PubMed Central

Denzen, Ellen M; Santibáñez, Martha E Burton; Moore, Heather; Foley, Amy; Gersten, Iris D; Gurgol, Cathy; Majhail, Navneet S; Spellecy, Ryan; Horowitz, Mary M; Murphy, Elizabeth A

2011-01-01

Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the US. The recent development of ICF templates by the National Cancer Institute, National Institutes of Health and the National Heart Blood and Lung Instituthas not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet US federal requirements and pass Institutional Review Board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a two-column layout. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared to the traditional format on the informed consent process. PMID:21806948

Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway.

PubMed

Sveinsdottir, Vigdis; Løvvik, Camilla; Fyhn, Tonje; Monstad, Karin; Ludvigsen, Kari; Øverland, Simon; Reme, Silje Endresen

2014-11-18

Roughly one third of disability pensions in Norway are issued for mental and behavioral disorders, and vocational rehabilitation offered to this group has traditionally been dominated by train-and-place approaches with assisted or sheltered employment. Based on a more innovative place-and-train approach, Individual Placement and Support (IPS) involves supported employment in real-life competitive work settings, and has shown great promise for patients with severe mental illness. The study is a multicenter Randomized Controlled Trial (RCT) of IPS in a Norwegian context, involving an effect evaluation, a process evaluation, and a cost/benefit analysis. IPS will be compared to high quality treatment as usual (TAU), with labor market participation and educational activity at 12 months post inclusion as the primary outcome. The primary outcome will be measured using register data, and the project will also include complete follow-up up to 4 years after inclusion for long-term outcome data. Secondary outcomes include mental health status, disability and quality of life, collected through survey questionnaires at baseline, and after 6 and 12 months. Participants will include patients undergoing treatment for moderate to severe mental illness who are either unemployed or on sickness or social benefits. The estimated total sample size of 400-500 will be randomly assigned to the interventions. To be eligible, participants must have an expressed desire to work, and sufficient Norwegian reading and writing skills to fill out the questionnaires. The Effect Evaluation of Individual Placement and Support (IPS) will be one of the largest randomized controlled trials to date investigating the effectiveness of IPS on competitive employment, and the first study to evaluate the effectiveness of IPS for patients with moderate to severe mental illness within a Norwegian context. Clinicaltrials.gov: NCT01964092 . Registered October 16th, 2013.

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.

PubMed

Ashoorkhani, Mahnaz; Bozorgi, Ali; Majdzadeh, Reza; Hosseini, Hamed; Yoonessi, Ali; Ramezankhani, Ali; Eftekhar, Hassan

2016-10-21

Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment. A two-arm, parallel-design randomized controlled clinical trial will be conducted on 30 to 60 year-old patients with primary hypertension who are attending the Tehran Heart Center. One hundred and thirty-two (132) patients will be randomly assigned to the intervention and control (usual method) groups. The most important inclusion criteria are, having primary hypertension and being pharmacologically treated for it, and not having developed the complications of hypertension, such as myocardial infarction, cerebral stroke and cardiac insufficiency. The participants should be able to read Persian and be able to use the application. The most important outcomes of the study include adherence to treatment, weight control, and regular monitoring of blood pressure which are assessed in the primary assessment (baseline data questionnaire) and again at the 8 th and 24 th weeks. The intervention is a mobile application that has capabilities such as reminders and scientific and supportive information. This application has been programmed to reduce many of the nonadherence factors of hypertension treatment. Therefore, the findings may contribute to a rise in adherence to treatment. If proven to have an appropriate impact, it may be extended for use in the national hypertension control plan. This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

The impact of dialogic book-sharing training on infant language and attention: a randomized controlled trial in a deprived South African community.

PubMed

Vally, Zahir; Murray, Lynne; Tomlinson, Mark; Cooper, Peter J

2015-08-01

Dialogic book-sharing is an interactive form of shared reading. It has been shown in high income countries (HICs) to be of significant benefit to child cognitive development. Evidence for such benefit in low and middle income countries (LMICs) is scarce, although a feasibility study of our own produced encouraging findings. Accordingly, we aimed to establish the impact on child language and attention of providing training in dialogic booksharing to carers of infants in an impoverished South African community. We conducted a randomized controlled trial in Khayelitsha, an informal settlement in South Africa. Mothers of infants aged between 14 and 16 months were recruited and randomized to either 8 weeks of manualized training in dialogic book-sharing or a no-intervention control group. Independent assessments were made of infant language and attention at baseline and following training. The trial was registered (ISRCTN39953901). Ninety one carer-infant dyads were recruited and randomized to the intervention group (n = 49) or the control group (n = 42), 82 (90%) of whom were available for follow-up assessments. On a standardized carer report of infant vocabulary, compared to those in the control group, carers who received the intervention reported a significantly greater increase in the number of words understood by their infants as well as a larger increase in the number of words that their infant understood and could vocalize. Intervention group children also showed substantially greater gains on a measure of sustained attention. In line with evidence from HICs, a dialogic book-sharing programme delivered to an impoverished South African sample was shown to be of considerable benefit to the development of child language and focussed attention. The training programme, which is simple and inexpensive to deliver, has the potential to benefit child cognitive development in LMIC contexts where such development is commonly compromised. © 2014 Association for Child and Adolescent Mental Health.

In Vivo Arthroscopic Temperatures: A Comparison Between 2 Types of Radiofrequency Ablation Systems in Arthroscopic Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Trial.

PubMed

Matthews, Brent; Wilkinson, Matthew; McEwen, Peter; Hazratwala, Kaushik; Doma, Kenji; Manoharan, Varaguna; Bahho, Zaid; McEwen, Shannon

2017-01-01

To compare a plasma ablation device with a standard ablation device in anterior cruciate ligament (ACL) reconstruction to determine which system is superior in terms of intra-articular heat generation and diathermy efficiency. This was a prospective, randomized controlled trial. The inclusion criteria were adult patients undergoing primary ACL reconstruction. Patients were randomized preoperatively to the standard ablation group or the plasma ablation group. A thermometer was inserted into the inferior suprapatellar pouch, and the temperature, time, and duration of radiofrequency ablation were measured continually. No significant differences were found between the standard ablation system and the plasma ablation system for maximum temperature (29.77°C and 29.34°C, respectively; P = .95), mean temperature (26.16°C and 26.99°C, respectively; P = .44), minimum temperature (22.66°C and 23.94°C, respectively; P = .54), and baseline temperature (26.80°C and 27.93°C, respectively; P = .35). Similarly, no significant differences were found for operative time (82.90 minutes and 80.50 minutes, respectively; P = .72) and mean diathermy activation times (2.6 minutes for both systems; P = .90). The between-system coefficient of variation for the measured parameters ranged from 0.12% to 3.69%. No intra-articular readings above the temperature likely to damage chondrocytes were recorded. The mean irrigation fluid temperature had a significant correlation with the maximum temperature reached during the procedure (Spearman rank correlation, r = 0.87; P < .01). No difference in temperature was observed between the standard ablation and plasma ablation probes during ACL reconstruction. Temperatures did not exceed critical temperatures associated with chondrocyte death. Level I, randomized controlled trial. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

The impact of dialogic book-sharing training on infant language and attention: a randomized controlled trial in a deprived South African community

PubMed Central

Vally, Zahir; Murray, Lynne; Tomlinson, Mark; Cooper, Peter J.

2015-01-01

Background Dialogic book-sharing is an interactive form of shared reading. It has been shown in high income countries (HICs) to be of significant benefit to child cognitive development. Evidence for such benefit in low and middle income countries (LMICs) is scarce, although a feasibility study of our own produced encouraging findings. Accordingly, we aimed to establish the impact on child language and attention of providing training in dialogic booksharing to carers of infants in an impoverished South African community. Methods We conducted a randomized controlled trial in Khayelitsha, an informal settlement in South Africa. Mothers of infants aged between 14 and 16 months were recruited and randomized to either eight weeks of manualized training in dialogic book-sharing or a no-intervention control group. Independent assessments were made of infant language and attention at baseline and following training. The trial was registered (ISRCTN39953901). Results Ninety one carer-infant dyads were recruited and randomized to the intervention group (n = 49) or the control group (n = 42), 82 (90%) of whom were available for follow-up assessments. On a standardized carer report of infant vocabulary, compared to those in the control group, carers who received the intervention reported a significantly greater increase in the number of words understood by their infants as well as a larger increase in the number of words that their infant understood and could vocalize. Intervention group children also showed substantially greater gains on a measure of sustained attention. Conclusions In line with evidence from HICs, a dialogic book-sharing programme delivered to an impoverished South African sample was shown to be of considerable benefit to the development of child language and focussed attention. The training programme, which is simple and inexpensive to deliver, has the potential to benefit child cognitive development in LMIC contexts where such development is commonly compromised. PMID:25399699

The IDEFICS intervention trial to prevent childhood obesity: design and study methods.

PubMed

Pigeot, I; Baranowski, T; De Henauw, S

2015-12-01

One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.

Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts.

PubMed

Murphy, D A; O'Keefe, Z H; Kaufman, A H

1999-10-01

A simplified version of the prototype HIV vaccine material was developed through (a) reducing reading grade level, (b) restructuring of the organization and categorization of the material, (c) adding pictures designed to emphasize key concepts, and (d) obtaining feedback on the simplified version through focus groups with the target population. Low-income women at risk for HIV (N = 141) recruited from a primary care clinic were randomly assigned to be presented the standard or the simplified version. There were no significant differences between the groups in terms of education or Vocabulary, Block Design, and Passage Comprehension scores. Women who received the simplified version had significantly higher comprehension scores immediately following presentation of the material than did women who received the standard version and were also significantly more likely to recall study benefits and risks. These findings were maintained at 3-month follow-up. Implications for informed consent are discussed.

Four-year-old outcomes of a universal infant-toddler shared reading intervention: the let's read trial.

PubMed

Goldfeld, Sharon; Quach, Jon; Nicholls, Ruth; Reilly, Sheena; Ukoumunne, Obioha C; Wake, Melissa

2012-11-01

To determine the emergent literacy and language effects of a low-intensity literacy promotion program (Let's Read) provided via universal well-child services to parents during the first 4 years of their child's life. Population-based, cluster randomized controlled trial performed between March 1, 2006, and December 10, 2010. Maternal and child health centers (clusters) in 5 relatively disadvantaged local government areas in Melbourne, Australia. All parents attending their 4-week well-child appointments in participating centers were invited to take part in the study. The Let's Read program was delivered at 4, 12, 18, and 42 months during universal well-child care visits. Child emergent literacy skills (intrasyllabic, phonemic, and sound/letter knowledge) and language (core, receptive, and expressive), measured at 4 years of age. A total of 630 parents participated, with 365 children in 32 intervention clusters and 265 children in 33 control clusters; 563 children (89.4%) were retained in the study to 4 years of age. The adjusted mean differences (intervention minus control) for emergent literacy was 0.2 (95% CI, -0.2 to 0.6; P = .29) for intrasyllabic units, 0.05 (95% CI, -0.4 to 0.5; P = .85) for phonemic awareness, and 0.1 (95% CI, -1.5 to 1.6; P = .92) for letter knowledge. For language, the differences were 1.6 (95% CI, -1.1 to 4.3; P = .25) for core, 0.8 (95% CI, -2.0 to 3.7; P = .56) for receptive, and 1.4 (95% CI, -1.4 to 4.2; P = .32) for expressive scores. This population-wide primary care literacy promotion and book distribution program provided neither the anticipated benefits to literacy and language nor enhanced uptake of literacy activities at 4 years of age, even when targeted to relatively disadvantaged areas. isrctn.org Identifier: ISRCTN04602902.

Using Technology and Assessment to Personalize Instruction: Preventing Reading Problems.

PubMed

Connor, Carol McDonald

2017-09-15

Children who fail to learn to read proficiently are at serious risk of referral to special education, grade retention, dropping out of high school, and entering the juvenile justice system. Accumulating research suggests that instruction regimes that rely on assessment to inform instruction are effective in improving the implementation of personalized instruction and, in turn, student learning. However, teachers find it difficult to interpret assessment results in a way that optimizes learning opportunities for all of the students in their classrooms. This article focuses on the use of language, decoding, and comprehension assessments to develop personalized plans of literacy instruction for students from kindergarten through third grade, and A2i technology designed to support teachers' use of assessment to guide instruction. Results of seven randomized controlled trials demonstrate that personalized literacy instruction is more effective than traditional instruction, and that sustained implementation of personalized literacy instruction first through third grade may prevent the development of serious reading problems. We found effect sizes from .2 to .4 per school year, which translates into about a 2-month advantage. These effects accumulated from first through third grade with a large effect size (d = .7) equivalent to a full grade-equivalent advantage on standardize tests of literacy. These results demonstrate the efficacy of technology-supported personalized data-driven literacy instruction to prevent serious reading difficulties. Implications for translational prevention research in education and healthcare are discussed.

Does Poor Spelling Equate to Slow Reading? The Relationship between Reading, Spelling, and Orthographic Quality

ERIC Educational Resources Information Center

Martin-Chang, Sandra; Ouellette, Gene; Madden, Melanie

2014-01-01

High quality lexical representations in memory, characterized by accuracy and stability, are said to underpin fluent reading. Here, the relationship between orthographic quality and reading speed was examined by asking undergraduates (N = 74) to repeatedly read and spell words. Spelling performance over five trials indicated orthographic quality.…

Recruiting older people at nutritional risk for clinical trials: what have we learned?

PubMed

Piantadosi, Cynthia; Chapman, Ian M; Naganathan, Vasi; Hunter, Peter; Cameron, Ian D; Visvanathan, Renuka

2015-04-15

The difficulty of recruiting older people to clinical trials is well described, but there is limited information about effective ways to screen and recruit older people into trials, and the reasons for their reluctance to enrol. This paper examines recruitment efforts for a community-based health intervention study that targeted older adults. One year randomized control trial. Undernourished men and women, aged ≥ 65 years and living independently in the community were recruited in three Australian states. Participants were allocated to either oral testosterone undecanoate and high calorie oral nutritional supplement or placebo medication and low calorie oral nutritional supplementation. Hospital admissions, functional status, nutritional health, muscle strength, and other variables were assessed. 4023 potential participants were identified and 767 were screened by a variety of methods: hospital note screening, referrals from geriatric health services, advertising and media segments/appearances. 53 participants (7% of total screened) were recruited. The majority of potentially eligible participants declined participation in the trial after reading the information sheet. Media was the more successful method of recruiting, whereas contacting people identified by screening a large number of hospital records was not successful in recruiting any participants. Recruitment of frail and older participants is difficult and multiple strategies are required to facilitate participation. Australian Clinical Trial Registry: ACTRN 12610000356066 date registered 4/5/2010.

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

NAEP 1994 Reading State Report for Department of Defense Education Activity Overseas Schools. Trial State Assessment.

ERIC Educational Resources Information Center

National Assessment of Educational Progress, Princeton, NJ.

In 1990, the National Assessment of Educational Progress (NAEP) included a Trial State Assessment (TSA); for the first time in NAEP's history, voluntary state-by-state assessments were made. In 1994, TSA was expanded to include non-public school students. The 1994 reading assessment considered students' proficiency in situations that involved…

DARTTS Diagnostic Assessments of Reading with Trial Teaching Strategies: Administrator's Summary. Report No. 9-49040.

ERIC Educational Resources Information Center

Riverside Publishing Co., Chicago. IL.

The Diagnostic Assessments of Reading with Trial Teaching Strategies (DARTTS) is a program of diagnostic tests with sample lessons in aspects of literacy. Developed by Florence G. Roswell and Jeanne S. Chall, the DARTTS program is published in a multilevel format for beginning through advanced (high school) readers. Teachers administer and score…

A systematic review on the effectiveness of titratable over nontitratable mandibular advancement appliances for sleep apnea.

PubMed

Sivaramakrishnan, Gowri; Sridharan, Kannan

2017-01-01

Mandibular advancement appliances are being tested for use in patients with obstructive sleep apnea (OSA). However, the effectiveness of titration of these appliances does not have conclusive evidence. Systematic reviews help us to compile all available clinical evidence using statistical principles. Hence, the aim of this systematic review is to identify the effectiveness of titratable over nontitratable mandibular advancement appliances in patients with mild to moderate OSA. This review objective is to identify if titration of these appliances produce significant benefits over fixed appliances. Electronic databases were searched to identify eligible studies based on set inclusion criteria. Data extraction form was created and the data were extracted. The participants were mild to moderate OSA patients who received mandibular advancement appliances. Studies included a comparison between titratable and nontitratable mandibular advancement appliance. Of the five included studies, three were observational and two were a randomized trial. All these studies were conducted in adults. The outcome attributes were polysomnographic readings and apnea-hypopnea index (AHI). A significant heterogeneity was seen between the eligible studies and hence a meta-analysis could not be performed. The results from this systematic review did not show significant advantages of titratable appliances, although titratable appliances performed better from individual studies as regards to reduction in AHI and polysomnography. The reason is the lack of sufficient clinical trials on the same. More high quality randomized controlled trials comparing titratable and fixed appliances have to be initiated to get to conclusive evidence.

Exploring Differential Effects Across Two Decoding Treatments on Item-Level Transfer in Children with Significant Word Reading Difficulties: A New Approach for Testing Intervention Elements.

PubMed

Steacy, Laura M; Elleman, Amy M; Lovett, Maureen W; Compton, Donald L

2016-01-01

In English, gains in decoding skill do not map directly onto increases in word reading. However, beyond the Self-Teaching Hypothesis (Share, 1995), little is known about the transfer of decoding skills to word reading. In this study, we offer a new approach to testing specific decoding elements on transfer to word reading. To illustrate, we modeled word-reading gains among children with reading disability (RD) enrolled in Phonological and Strategy Training (PHAST) or Phonics for Reading (PFR). Conditions differed in sublexical training with PHAST stressing multi-level connections and PFR emphasizing simple grapheme-phoneme correspondences. Thirty-seven children with RD, 3 rd - 6 th grade, were randomly assigned 60 lessons of PHAST or PFR. Crossed random-effects models allowed us to identify specific intervention elements that differentially impacted word-reading performance at posttest, with children in PHAST better able to read words with variant vowel pronunciations. Results suggest that sublexical emphasis influences transfer gains to word reading.

Effect of Music Therapy on Patients' Anxiety and Hemodynamic Parameters During Coronary Angioplasty: A Randomized Controlled Trial.

PubMed

Forooghy, Masoumeh; Mottahedian Tabrizi, Elaheh; Hajizadeh, Ebrahim; Pishgoo, Bahram

2015-06-01

A cardiac catheterization laboratory can be a frightening environment and music can be a supportive source of environmental sound that stimulates and maintains relaxation. However, the results of studies are conflicting in this regard. The aim of this study was to investigate the effect of music therapy on patients' anxiety and hemodynamic parameters during percutaneous transluminal coronary angioplasty. This was a randomized controlled trial, conducted in the Catheterization Laboratory Unit of Baqiyatallah Hospital, in Tehran, Iran. A sample of 64 patients, who were planned to undergo coronary angioplasty, was recruited. Patients were randomly allocated to either the control or the experimental groups. In the experimental group, patients received a 20 to 40-minute music therapy intervention, consisting of light instrumental music albums by Johann Sebastian Bach and Mariko Makino. Patients in the control group received the routine care of the study setting, which consisted of no music therapy intervention. Study data were collected by a demographic questionnaire, the Spielberger's State Anxiety Inventory, and a data sheet for documenting hemodynamic parameters. Chi-square, independent-samples t tests, paired-samples t-test and repeated measures analysis of variance were used to analyze the data. Before the intervention, the study groups did not differ significantly in terms of anxiety level and hemodynamic parameters. Moreover, the differences between the two groups, regarding hemodynamic parameters, were not significant after the intervention (P > 0.05). However, the level of post-intervention anxiety in the experimental group was significantly lower than the control group (32.06 ± 8.57 and 38.97 ± 12.77, respectively; P = 0.014). Compared with the baseline readings, the level of anxiety in the control group did not change significantly after the study (41.91 ± 9.88 vs. 38.97 ± 12.77; P = 0.101); however, in the experimental group, the level of post-intervention anxiety was significantly lower than the pretest readings (32.06 ± 8.57 vs. 41.16 ± 10.6; P = 0.001). Music therapy is a safe, simple, inexpensive, and non-invasive nursing intervention, which can significantly alleviate patients' anxiety during coronary angioplasty.

Fluency Gains in Struggling College Readers from Wide Reading and Repeated Readings

ERIC Educational Resources Information Center

Ari, Omer

2015-01-01

Effects of wide reading and repeated readings were examined on struggling college readers' silent reading rate and reading comprehension relative to a vocabulary study control condition. Randomly assigned to a condition, community college students (N = 30) completed 25-min sessions individually in class three times a week for three weeks.…

Findings from a Multi-Year Scale-Up Effectiveness Trial of Open-Court Reading (Imagine It!)

ERIC Educational Resources Information Center

Vaden-Kiernan, Michael; Borman, Geoffrey; Caverly, Sarah; Bell, Nance; de Castilla, Veronica Ruiz; Sullivan, Kate; Fleming, Grace

2016-01-01

This study addresses the effectiveness of a widely used core reading program that reflects the research-based practices recommended by the National Reading Panel. This and other similar programs are increasingly used to prevent reading difficulties and ensure that all children are reading at or above grade level by the end of third grade.…

Preliminary Findings from a Multi-Year Scale-Up Effectiveness Trial of Open-Court Reading (Imagine It!)

ERIC Educational Resources Information Center

Borman, Geoffrey; Vaden-Kiernan, Michael; Caverly, Sarah; Bell, Nance; de Castilla, Veronica Ruiz; Sullivan, Kate

2015-01-01

This study addresses the effectiveness of a nationally used core reading program that reflects the research-based practices recommended by the National Reading Panel. This and other similar programs are increasingly used to prevent reading difficulties and ensure that all children are reading at or above grade level by the end of third grade. The…

Methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association, 1999-2013.

PubMed

Landorf, Karl B; Menz, Hylton B; Armstrong, David G; Herbert, Robert D

2015-07-01

Randomized trials must be of high methodological quality to yield credible, actionable findings. The main aim of this project was to evaluate whether there has been an improvement in the methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association (JAPMA). Randomized trials published in JAPMA during a 15-year period (January 1999 to December 2013) were evaluated. The methodological quality of randomized trials was evaluated using the PEDro scale (scores range from 0 to 10, with 0 being lowest quality). Linear regression was used to assess changes in methodological quality over time. A total of 1,143 articles were published in JAPMA between January 1999 and December 2013. Of these, 44 articles were reports of randomized trials. Although the number of randomized trials published each year increased, there was only minimal improvement in their methodological quality (mean rate of improvement = 0.01 points per year). The methodological quality of the trials studied was typically moderate, with a mean ± SD PEDro score of 5.1 ± 1.5. Although there were a few high-quality randomized trials published in the journal, most (84.1%) scored between 3 and 6. Although there has been an increase in the number of randomized trials published in JAPMA, there is substantial opportunity for improvement in the methodological quality of trials published in the journal. Researchers seeking to publish reports of randomized trials should seek to meet current best-practice standards in the conduct and reporting of their trials.

The Diagnosis and Treatment of Reading and/or Spelling Disorders in Children and Adolescents.

PubMed

Galuschka, Katharina; Schulte-Körne, Gerd

2016-04-22

3-11% of children and adolescents suffer from a reading andor spelling disorder. Their poor written-language skills markedly impair their scholastic performance and are often associated with other mental disorders. A great deal of uncertainty still surrounds the question of the appropriate methods of diagnosis and treatment. We systematically searched for pertinent publications in databases and literature reference lists, summarized the evidence in six tables, and examined some of it in a meta-analysis. Recommendations were developed in a consensus conference. A reading and/or spelling disorder should only be diagnosed if performance in these areas is below average. It should be determined whether an attention deficit-hyperactivity disorder, anxiety disorder, or disorder of arithmetical skills is also present. Reading and spelling performance should be reinforced with systematic instruction about letter-sound and sound-letter correspondences, letter-syllable-morpheme synthesis, and sound-syllablemorpheme analysis (g' = 0.32) (recommendation grade A). Spelling ability responds best to spelling-rule training (recommendation grade A). Irlen lenses, visual and/or auditory perceptual training, hemispheric stimulation, piracetam, and prism spectacles should not be used (recommendation grade A). Evidence- and consensus-based guidelines for the diagnosis and treatment of reading and/or spelling disorders in children and adolescents are now available for the first time. Reading and spelling abilities should be systematically and comprehensively reinforced, and potential comorbid disorders should be sought and treated appropriately. The efficacy of many treatments now in use has not been documented; if they are to be used in the future, they must be tested in randomized, controlled trials. For adult sufferers, adequate diagnostic instruments and therapeutic methods are not yet available.

EFFECT OF QUALITY OF CHEST RADIOGRAPHS ON THE CATEGORIZATION OF COALWORKERS' PNEUMOCONIOSIS

PubMed Central

Pearson, N. G.; Ashford, J. R.; Morgan, D. C.; Pasqual, R. S. H.; Rae, S.

1965-01-01

An investigation into the effect of variations in radiographic technical quality on pneumoconiosis reading standards in the Pneumoconiosis Field Research of the National Coal Board is reported. From the group of men for whom retake films had been obtained because of unsatisfactory technique of the originals, a trial series of pairs and triplets of films showing differing technique was assembled. A total of 778 films was read for pneumoconiosis and assessed for technical quality by four readers. The quality was assessed in terms of three separate factors, viz., density (at high, medium, and low levels), contrast (satisfactory and unsatisfactory), and definition (satisfactory and unsatisfactory). The intra and inter observer consistency of this assessment was estimated, and the effect of techical quality on the reading of pneumoconiosis category was determined. A tendency for lower pneumoconiosis readings to be recorded on films with unsatisfactory technique was demonstrated. A random 10% sample of the best available films (those on which routine pneumoconiosis readings have been made) for all men examined since the beginning of the research was also read for technical quality. Of the total of 4,188 films, 80% were considered satisfactory. It appeared that films taken on second surveys were, in general, of rather better quality than those taken on first surveys. The physical attributes of the men examined had some effect on the technical standards, the proportion of unsatisfactory films rising with increasing values of the weight/sitting height ratio and being greater in men with pneumoconiosis categories 1 and A and in the middle age group. The tendency for lower pneumoconiosis readings to be recorded on films with unsatisfactory technique is in contrast to the results of work previously published. Different criteria for the selection of films and the assessment of technical quality, and possibly differing reading conventions, make comparison with other work difficult. PMID:14278806

Revisiting sample size: are big trials the answer?

PubMed

Lurati Buse, Giovanna A L; Botto, Fernando; Devereaux, P J

2012-07-18

The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence.

Digital Reading Disposition Scale: A Study of Validity and Reliability

ERIC Educational Resources Information Center

Bulut, Berker; Karasakaloglu, Nuri

2018-01-01

In this study, "a Digital Reading Disposition Scale" was developed to determine undergraduate pre-service teacher students' dispositions towards digital reading, opposed to a preference for printed reading material. Initially, a 20-items trial version of the scale was administered to a total sample of N = 301 undergraduate pre-service…

Does Early Reading Failure Decrease Children's Reading Motivation?

ERIC Educational Resources Information Center

Morgan, Paul L.; Fuchs, Douglas; Compton, Donald L.; Cordray, David S.; Fuchs, Lynn S.

2008-01-01

The authors used a pretest-posttest control group design with random assignment to evaluate whether early reading failure decreases children's motivation to practice reading. First, they investigated whether 60 first-grade children would report substantially different levels of interest in reading as a function of their relative success or failure…

Impacts of Dialogical Storybook Reading on Young Children's Reading Attitudes and Vocabulary Development

ERIC Educational Resources Information Center

Kotaman, Huseyin

2013-01-01

The current study assessed the impact of parents' dialogical storybook reading on their children's receptive vocabulary and reading attitudes. Forty parents and their preschoolers participated in the study. Parents were randomly assigned to experimental or control groups. The experimental group received dialogical storybook reading training.…

A randomized trial of pictorial versus prose-based medication information pamphlets.

PubMed

Thompson, Andrew E; Goldszmidt, Mark A; Schwartz, Alan J; Bashook, Philip G

2010-03-01

The goal of this study was to compare prose and pictorial-based information pamphlets about the medication methotrexate in the domains of free recall, cued recall, comprehension and utility. A single blind, randomized trial of picture versus prose-based information pamphlets including 100 participants aged 18-65 years of age, who had not completed high school, could read English, and had no prior knowledge about methotrexate. Superiority of pamphlet type was assessed using immediate free recall, cued recall and comprehension. There were no differences between picture and prose pamphlets in free recall, cued recall, and comprehension either immediately or after a 1-week interval. Immediate free recall of important information was 17-26%; free recall fell even lower to 7-16% after 1 week. The pictorial pamphlet was preferred over the prose-based pamphlet. This study found no benefit in free recall, cued recall, or comprehension through the addition of pictograms to a simple prose-based medication pamphlet. In order for them to be effective in clinical practice, even simple medication information pamphlets that have been assessed for patients' ability to comprehend them cannot be used as the sole means for conveying important medication-related information to patients. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

Computerized Silent Reading Rate and Strategy Instruction for Fourth Graders at Risk in Silent Reading Rate

ERIC Educational Resources Information Center

Niedo, Jasmin; Lee, Yen-Ling; Breznitz, Zvia; Berninger, Virginia W.

2014-01-01

Fourth graders whose silent word reading and/or sentence reading rate was, on average, two-thirds standard deviation below their oral reading of real and pseudowords and reading comprehension accuracy were randomly assigned to treatment ("n" = 7) or wait-listed ("n" = 7) control groups. Following nine sessions combining…

Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial.

PubMed

Mackillop, Lucy; Hirst, Jane Elizabeth; Bartlett, Katy Jane; Birks, Jacqueline Susan; Clifton, Lei; Farmer, Andrew J; Gibson, Oliver; Kenworthy, Yvonne; Levy, Jonathan Cummings; Loerup, Lise; Rivero-Arias, Oliver; Ming, Wai-Kit; Velardo, Carmelo; Tarassenko, Lionel

2018-03-20

Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits. We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance. Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study. A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (-0.16 mmol/L in the intervention and -0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean 2.63 [SD 1.71] readings per day in the intervention and control groups, respectively; P<.001). There was no significant difference in direct health care costs between the two groups, with a mean cost difference of the intervention group compared to control of -£1044 (95% CI -£2186 to £99). There were no unexpected adverse outcomes. Remote blood glucocse monitoring in women with GDM is safe. We demonstrated superior data capture using GDm-health. Although glycemic control and maternal and neonatal outcomes were similar, women preferred this model of care. Further studies are required to explore whether digital health solutions can promote desired self-management lifestyle behaviors and dietetic adherence, and influence maternal and neonatal outcomes. Digital blood glucose monitoring may provide a scalable, practical method to address the growing burden of GDM around the world. ClinicalTrials.gov NCT01916694; https://clinicaltrials.gov/ct2/show/NCT01916694 (Archived by WebCite at http://www.webcitation.org/6y3lh2BOQ). ©Lucy Mackillop, Jane Elizabeth Hirst, Katy Jane Bartlett, Jacqueline Susan Birks, Lei Clifton, Andrew J Farmer, Oliver Gibson, Yvonne Kenworthy, Jonathan Cummings Levy, Lise Loerup, Oliver Rivero-Arias, Wai-Kit Ming, Carmelo Velardo, Lionel Tarassenko. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.03.2018.

Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension.

PubMed

Rifkin, Dena E; Abdelmalek, Joseph A; Miracle, Cynthia M; Low, Chai; Barsotti, Ryan; Rios, Phil; Stepnowsky, Carl; Agha, Zia

2013-02-01

Older adults with chronic kidney disease have a high rate of uncontrolled hypertension. Home monitoring of blood pressure (BP) is an integral part of management, but requires that patients bring records to clinic visits. Telemonitoring interventions, however, have not targeted older, less technologically-skilled populations. Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were randomized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub, which wirelessly transmitted readings (n=28), or usual care (n=15). Home recordings were reviewed weekly and telemonitoring participants were contacted if BP was above goal. The prespecified primary endpoints were improved data exchange and device acceptability. Secondary endpoint was BP change. Forty-three participants (average age 68 years, 75% white) completed the 6-month study. Average start-of-study BP was 147/78 mmHg. Those in the intervention arm had a median of 29 (IQR 22, 53) transmitted BP readings per month, with 78% continuing to use the device regularly, whereas only 20% of those in the usual care group brought readings to in-person visits. The median number of telephone contacts triggered by the wireless monitoring was 2 (IQR 1, 4) per patient. Both groups had a significant improvement in systolic BP (P<0.05, for both changes); systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5 mmHg in usual care participants (P for comparison 0.31). This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months.

Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

PubMed

NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data From the Efficacy Trial for Lunch Is in the Bag.

PubMed

Roberts-Gray, Cindy; Sweitzer, Sara J; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E; Briley, Margaret E; Hoelscher, Deanna M

2017-08-01

A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the Lunch Is in the Bag intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). To examine the utility of structuring the trial's process evaluation to forecast use, sustainability, and readiness of the intervention for wider dissemination and implementation. Pretrial, the research team simulated user experience to forecast use of the intervention. Multiattribute evaluation of user experience measured during the trial assessed use and sustainability of the intervention. Thematic analysis of posttrial interviews with users evaluated sustained use and readiness for wider dissemination. Moderate use was forecast by the research team. Multiattribute evaluation of activity logs, surveys, and observations during the trial indicated use consistent with the forecast except that prevalence of parents reading the newsletters was greater (83% vs. 50%) and hearing their children talk about the classroom was less (4% vs. 50%) than forecast. Early care and education center-level likelihood of sustained use was projected to be near zero. Posttrial interviews indicated use was sustained at zero centers. Structuring the efficacy trial's process evaluation as a progression of assessments of user experience produced generally accurate forecasts of use and sustainability of the intervention at the trial sites. This approach can assist interpretation of trial outcomes, aid decisions about dissemination of the intervention, and contribute to translational science for improving health.

Differential Effects of Context and Feedback on Orthographic Learning: How Good Is Good Enough?

ERIC Educational Resources Information Center

Martin-Chang, Sandra; Ouellette, Gene; Bond, Linda

2017-01-01

In this study, students in Grade 2 read different sets of words under 4 experimental training conditions (context/feedback, isolation/feedback, context/no-feedback, isolation/no-feedback). Training took place over 10 trials, followed by a spelling test and a delayed reading posttest. Reading in context boosted reading accuracy initially; in…

A Shared Reading Intervention with Parents to Enhance Young Children's Early Literacy Skills

ERIC Educational Resources Information Center

Sim, Susan S. H.; Berthelsen, Donna; Walker, Susan; Nicholson, Jan M.; Fielding-Barnsley, Ruth

2014-01-01

A pragmatic randomised controlled trial was used to investigate the effects of two forms of shared reading on children's language and literacy skills. Parents of 80 children in the preparatory year of school participated in an eight-week home reading intervention. Families were assigned to one of three groups: dialogic reading (DR), dialogic…

Dyslexics’ faster decay of implicit memory for sounds and words is manifested in their shorter neural adaptation

PubMed Central

Jaffe-Dax, Sagi; Frenkel, Or; Ahissar, Merav

2017-01-01

Dyslexia is a prevalent reading disability whose underlying mechanisms are still disputed. We studied the neural mechanisms underlying dyslexia using a simple frequency-discrimination task. Though participants were asked to compare the two tones in each trial, implicit memory of previous trials affected their responses. We hypothesized that implicit memory decays faster among dyslexics. We tested this by increasing the temporal intervals between consecutive trials, and by measuring the behavioral impact and ERP responses from the auditory cortex. Dyslexics showed a faster decay of implicit memory effects on both measures, with similar time constants. Finally, faster decay of implicit memory also characterized the impact of sound regularities in benefitting dyslexics' oral reading rate. Their benefit decreased faster as a function of the time interval from the previous reading of the same non-word. We propose that dyslexics’ shorter neural adaptation paradoxically accounts for their longer reading times, since it reduces their temporal window of integration of past stimuli, resulting in noisier and less reliable predictions for both simple and complex stimuli. Less reliable predictions limit their acquisition of reading expertise. DOI: http://dx.doi.org/10.7554/eLife.20557.001 PMID:28115055

A randomized controlled trial to test the efficacy of the SCI Get Fit Toolkit on leisure-time physical activity behaviour and social-cognitive processes in adults with spinal cord injury.

PubMed

Arbour-Nicitopoulos, Kelly P; Sweet, Shane N; Lamontagne, Marie-Eve; Ginis, Kathleen A Martin; Jeske, Samantha; Routhier, François; Latimer-Cheung, Amy E

2017-01-01

Single blind, two-group randomized controlled trial. To evaluate the efficacy of the SCI Get Fit Toolkit delivered online on theoretical constructs and moderate-to-vigorous physical activity (MVPA) among adults with SCI. Ontario and Quebec, Canada. Inactive, English- and French-speaking Canadian adults with traumatic SCI with Internet access, and no self-reported cognitive or memory impairments. Participants ( N =90 M age =48.12±11.29 years; 79% male) were randomized to view the SCI Get Fit Toolkit or the Physical Activity Guidelines for adults with SCI (PAG-SCI) online. Primary (intentions) and secondary (outcome expectancies, self-efficacy, planning and MVPA behaviour) outcomes were assessed over a 1-month period. Of the 90 participants randomized, 77 were included in the analyses. Participants viewed the experimental stimuli only briefly, reading the 4-page toolkit for approximately 2.5 min longer than the 1-page guideline document. No condition effects were found for intentions, outcome expectancies, self-efficacy, and planning (ΔR 2 ⩽0.03). Individuals in the toolkit condition were more likely to participate in at least one bout of 20 min of MVPA behaviour at 1-week post-intervention compared to individuals in the guidelines condition (OR=3.54, 95% CI=0.95, 13.17). However, no differences were found when examining change in weekly minutes of MVPA or comparing whether participants met the PAG-SCI. No firm conclusions can be made regarding the impact of the SCI Get Fit Toolkit in comparison to the PAG-SCI on social cognitions and MVPA behaviour. The limited online access to this resource may partially explain these null findings.

Early diagnostic suggestions improve accuracy of family physicians: a randomized controlled trial in Greece.

PubMed

Kostopoulou, Olga; Lionis, Christos; Angelaki, Agapi; Ayis, Salma; Durbaba, Stevo; Delaney, Brendan C

2015-06-01

In a recent randomized controlled trial, providing UK family physicians with 'early support' (possible diagnoses to consider before any information gathering) was associated with diagnosing hypothetical patients on computer more accurately than control. Another group of physicians, who gathered information, gave a diagnosis, and subsequently received a list of possible diagnoses to consider ('late support'), were no more accurate than control, despite being able to change their initial diagnoses. To replicate the UK study findings in another country with a different primary health care system. All study materials were translated into Greek. Greek family physicians were randomly allocated to one of three groups: control, early support and late support. Participants saw nine scenarios in random order. After reading some information about the patient and the reason for encounter, they requested more information to diagnose. The main outcome measure was diagnostic accuracy. One hundred fifty Greek family physicians participated. The early support group was more accurate than control [odds ratio (OR): 1.67 (1.21-2.31)]. Like their UK counterparts, physicians in the late support group rarely changed their initial diagnoses after receiving support. The pooled OR for the early support versus control comparison from the meta-analysis of the UK and Greek data was 1.40 (1.13-1.67). Using the same methodology with a different sample of family physicians in a different country, we found that suggesting diagnoses to consider before physicians start gathering information was associated with more accurate diagnoses. This constitutes further supportive evidence of a generalizable effect of early support. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Oxytocin effects on mind-reading are moderated by experiences of maternal love withdrawal: an fMRI study.

PubMed

Riem, Madelon M E; Bakermans-Kranenburg, Marian J; Voorthuis, Alexandra; van IJzendoorn, Marinus H

2014-06-03

The neuropeptide oxytocin has been shown to stimulate a range of social behaviors. However, recent studies indicate that the effects of intranasal oxytocin are more nuanced than previously thought and that contextual factors and individual characteristics moderate the beneficiary oxytocin effects. In this randomized-controlled trial we examine the influence of intranasally administered oxytocin on neural activity during mind-reading with fMRI, taking into account harsh caregiving experiences as a potential moderator. Participants were 50 women who received a nasal spray containing either 16 IU of oxytocin or a placebo and had reported how often their mother used love withdrawal as a disciplinary strategy. Participants performed an adapted version of the Reading the Mind in the Eyes Test (RMET), a task which requires individuals to infer mental states by looking at photographs of the eye region of faces. We found that oxytocin enhanced neural activation in the superior temporal gyrus (STG) and insula during the RMET. Moreover, oxytocin increased RMET performance outside the scanner. However, the oxytocin induced changes in STG activation and RMET performance were only brought about in potentially less socially proficient individuals who had low RMET performance, that is, participants reporting higher levels of maternal love withdrawal. Copyright © 2014 Elsevier Inc. All rights reserved.

The Effects of Pre-Reading Activities on Reading Comprehension of Iranian EFL Learners

ERIC Educational Resources Information Center

Moghaddam, Nahid Nemati; Mahmoudi, Asgar

2016-01-01

This study investigated the effects of three types of pre-reading activities (movie-watching, vocabulary presentation, and pre-reading summarization) on the reading comprehension of 76 elementary-level EFL Iranian learners. The participants were randomly assigned to one control and three experimental conditions and then a pretest was given to…

Interventions for Reading Difficulties: A Comparison of Response to Intervention by ELL and EFL Struggling Readers

ERIC Educational Resources Information Center

Lovett, Maureen W.; De Palma, Maria; Frijters, Jan; Steinbach, Karen; Temple, Meredith; Benson, Nancy; Lacerenza, Lea

2008-01-01

This article explores whether struggling readers from different primary language backgrounds differ in response to phonologically based remediation. Following random assignment to one of three reading interventions or to a special education reading control program, reading and reading-related outcomes of 166 struggling readers were assessed…

Effects of an Informational Text Reading Comprehension Intervention for Fifth-Grade Students

ERIC Educational Resources Information Center

Ritchey, Kristen D.; Palombo, Kimberly; Silverman, Rebecca D.; Speece, Deborah L.

2017-01-01

Upper elementary school students who have reading problems may have difficulty in one or more areas of reading, each requiring specific types of interventions. This study evaluated a short-term reading intervention for 46 fifth-grade students with poor reading comprehension. Students were randomly assigned to an intervention or no treatment…

An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial.

PubMed

Richardson, Caroline R; Buis, Lorraine R; Janney, Adrienne W; Goodrich, David E; Sen, Ananda; Hess, Michael L; Mehari, Kathleen S; Fortlage, Laurie A; Resnick, Paul J; Zikmund-Fisher, Brian J; Strecher, Victor J; Piette, John D

2010-12-17

Approximately half of American adults do not meet recommended physical activity guidelines. Face-to-face lifestyle interventions improve health outcomes but are unlikely to yield population-level improvements because they can be difficult to disseminate, expensive to maintain, and inconvenient for the recipient. In contrast, Internet-based behavior change interventions can be disseminated widely at a lower cost. However, the impact of some Internet-mediated programs is limited by high attrition rates. Online communities that allow participants to communicate with each other by posting and reading messages may decrease participant attrition. Our objective was to measure the impact of adding online community features to an Internet-mediated walking program on participant attrition and average daily step counts. This randomized controlled trial included sedentary, ambulatory adults who used email regularly and had at least 1 of the following: overweight (body mass index [BMI] ≥ 25), type 2 diabetes, or coronary artery disease. All participants (n = 324) wore enhanced pedometers throughout the 16-week intervention and uploaded step-count data to the study server. Participants could log in to the study website to view graphs of their walking progress, individually-tailored motivational messages, and weekly calculated goals. Participants were randomized to 1 of 2 versions of a Web-based walking program. Those randomized to the "online community" arm could post and read messages with other participants while those randomized to the "no online community" arm could not read or post messages. The main outcome measures were participant attrition and average daily step counts over 16 weeks. Multiple regression analyses assessed the effect of the online community access controlling for age, sex, disease status, BMI, and baseline step counts. Both arms significantly increased their average daily steps between baseline and the end of the intervention period, but there were no significant differences in increase in step counts between arms using either intention-to-treat or completers analysis. In the intention-to-treat analysis, the average step count increase across both arms was 1888 ± 2400 steps. The percentage of completers was 13% higher in the online community arm than the no online community arm (online community arm, 79%, no online community arm, 66%, P = .02). In addition, online community arm participants remained engaged in the program longer than no online community arm participants (hazard ratio = 0.47, 95% CI = 0.25 - 0.90, P = .02). Participants with lower baseline social support posted more messages to the online community (P < .001) and viewed more posts (P < .001) than participants with higher baseline social support. Adding online community features to an Internet-mediated walking program did not increase average daily step counts but did reduce participant attrition. Participants with low baseline social support used the online community features more than those with high baseline social support. Thus, online communities may be a promising approach to reducing attrition from online health behavior change interventions, particularly in populations with low social support. NCT00729040; http://clinicaltrials.gov/ct2/show/NCT00729040 (Archived by WebCite at http://www.webcitation.org/5v1VH3n0A).

The management and treatment of hypertension.

PubMed

Germino, F Wilford

2009-01-01

High blood pressure (HBP) is one of the most prevalent conditions seen today by clinicians, affecting an estimated 73 million--or 1 in 3--adult Americans, only one third of whom have achieved control of their hypertension (HBP). Central to the management of this pervasive medical condition are the issues of accurate diagnosis and maintaining control through appropriate treatment. Accurate diagnosis depends primarily on reliable measurement. Over the years, it has become increasingly recognized that blood pressure (BP) measurement occurring in clinical settings produces far less accurate and reliable readings than do other methods, notably 24-hour ambulatory BP monitoring and home BP measurement. Beyond technique, there are additional challenges to obtaining accurate readings, including emotional factors that produce either falsely elevated or lowered results, having the potential to mislead the clinician. The need to overcome obstacles to proper diagnosis and determine effective treatments has reached heightened urgency, especially for patients with compelling comorbidities such as diabetes, renal disease, congestive heart failure, and other cardiovascular diseases. The continuing evolution of the management of HBP is reflected in updated guidelines from the American Heart Association and evidence-based information stemming from recent studies and randomized clinical trials. The appropriate selection of antihypertensive agents, at the proper doses, is a complex issue requiring greater understanding of our pharmacologic options. The contributions of some of the more recent and salient studies and trials are mentioned here, although there is no attempt in this brief review to match drug classes with compelling indications. The trials discussed involve such pharmacologic treatments as diuretic therapy, alpha-blockers, conventional beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers. Trial outcomes shed light on the relative benefits and drawbacks of these agents, often within the context of various patient characteristics such as age, comorbidities, and risk status. Successful management of HBP is a multi-faceted and ongoing endeavor, in which developing knowledge constantly tempered by new questions moves us toward the goal of improving the lives of our patients.

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

PubMed

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

2016-02-01

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

The Impact of Supplemental Antioxidants on Visual Function in Nonadvanced Age-Related Macular Degeneration: A Head-to-Head Randomized Clinical Trial.

PubMed

Akuffo, Kwadwo Owusu; Beatty, Stephen; Peto, Tunde; Stack, Jim; Stringham, Jim; Kelly, David; Leung, Irene; Corcoran, Laura; Nolan, John M

2017-10-01

The purpose of this study was to evaluate the impact of supplemental macular carotenoids (including versus not including meso-zeaxanthin) in combination with coantioxidants on visual function in patients with nonadvanced age-related macular degeneration. In this study, 121 participants were randomly assigned to group 1 (Age-Related Eye Disease Study 2 formulation with a low dose [25 mg] of zinc and an addition of 10 mg meso-zeaxanthin; n = 60) or group 2 (Age-Related Eye Disease Study 2 formulation with a low dose [25 mg] of zinc; n = 61). Visual function was assessed using best-corrected visual acuity, contrast sensitivity (CS), glare disability, retinal straylight, photostress recovery time, reading performance, and the National Eye Institute Visual Function Questionnaire-25. Macular pigment was measured using customized heterochromatic flicker photometry. There was a statistically significant improvement in the primary outcome measure (letter CS at 6 cycles per degree [6 cpd]) over time (P = 0.013), and this observed improvement was statistically comparable between interventions (P = 0.881). Statistically significant improvements in several secondary outcome visual function measures (letter CS at 1.2 and 2.4 cpd; mesopic and photopic CS at all spatial frequencies; mesopic glare disability at 1.5, 3, and 6 cpd; photopic glare disability at 1.5, 3, 6, and 12 cpd; photostress recovery time; retinal straylight; mean and maximum reading speed) were also observed over time (P < 0.05, for all), and were statistically comparable between interventions (P > 0.05, for all). Statistically significant increases in macular pigment at all eccentricities were observed over time (P < 0.0005, for all), and the degree of augmentation was statistically comparable between interventions (P > 0.05). Antioxidant supplementation in patients with nonadvanced age-related macular degeneration results in significant increases in macular pigment and improvements in CS and other measures of visual function. (Clinical trial, http://www.isrctn.com/ISRCTN13894787).

Evidence for a Simplicity Principle: Teaching Common Complex Grapheme-to-Phonemes Improves Reading and Motivation in At-Risk Readers

ERIC Educational Resources Information Center

Chen, Victoria; Savage, Robert S.

2014-01-01

This study examines the effects of teaching common complex grapheme-to-phoneme correspondences (GPCs) on reading and reading motivation for at-risk readers using a randomised control trial design with taught intervention and control conditions. One reading programme taught children complex GPCs ordered by their frequency of occurrence in…

Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

ERIC Educational Resources Information Center

Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

2016-01-01

Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

Effects of a Computer-Based Early Reading Program on the Early Reading and Oral Language Skills of At-Risk Preschool Children

ERIC Educational Resources Information Center

Huffstetter, Mary; King, James R.; Onwuegbuzie, Anthony J.; Schneider, Jenifer J.; Powell-Smith, Kelly A.

2010-01-01

This study examined the effects of a computer-based early reading program (Headsprout Early Reading) on the oral language and early reading skills of at-risk preschool children. In a pretest-posttest control group design, 62 children were randomly assigned to receive supplemental instruction with Headsprout Early Reading (experimental group) or…

Reading Intervention Using Interactive Metronome in Children with Language and Reading Impairment: A Preliminary Investigation

ERIC Educational Resources Information Center

Ritter, Michaela; Colson, Karen A.; Park, Jungjun

2013-01-01

This exploratory study examined the effects of Interactive Metronome (IM) when integrated with a traditional language and reading intervention on reading achievement. Forty-nine school-age children with language and reading impairments were assigned randomly to either an experimental group who received the IM treatment or to a control group who…

Reading Linear Texts on Paper versus Computer Screen: Effects on Reading Comprehension

ERIC Educational Resources Information Center

Mangen, Anne; Walgermo, Bente R.; Bronnick, Kolbjorn

2013-01-01

Objective: To explore effects of the technological interface on reading comprehension in a Norwegian school context. Participants: 72 tenth graders from two different primary schools in Norway. Method: The students were randomized into two groups, where the first group read two texts (1400-2000 words) in print, and the other group read the same…

The Effects of an Intensive Reading Intervention for Ninth Graders with Very Low Reading Comprehension

ERIC Educational Resources Information Center

Solís, Michael; Vaughn, Sharon; Scammacca, Nancy

2015-01-01

This experimental study examined the efficacy of a multicomponent reading intervention compared to a control condition on the reading comprehension of adolescent students with low reading comprehension (more than 1½ standard deviations below normative sample). Ninth-grade students were randomly assigned to treatment (n = 25) and comparison (n =…

Reading Readiness and Early Linguistic Skills as a Function of Individual Differences in the Orienting Response. Working Paper No. 94.

ERIC Educational Resources Information Center

Berkowitz, Gloria D.; Farley, Frank H.

The research paradigm of Farley and Manske on individual differences in the orienting response (OR) defined by heart rate (HR) deceleration was extended to performance in reading readiness tasks. The OR was measured in 114 kindergarteners. Fifteen trials of pure tone stimulation (1000 cps, 61 db) followed by a 16th trial at 2000 cps and a…

A Randomized Experiment of a Mixed-Methods Literacy Intervention for Struggling Readers in Grades 4-6: Effects on Word Reading Efficiency, Reading Comprehension and Vocabulary, and Oral Reading Fluency

ERIC Educational Resources Information Center

Kim, James S.; Samson, Jennifer F.; Fitzgerald, Robert; Hartry, Ardice

2010-01-01

The purpose of this study was (1) to examine the causal effects of READ 180, a mixed-methods literacy intervention, on measures of word reading efficiency, reading comprehension and vocabulary, and oral reading fluency and (2) to examine whether print exposure among children in the experimental condition explained variance in posttest reading…

The Effect of CAI on Reading Achievement.

ERIC Educational Resources Information Center

Hardman, Regina

A study determined whether computer assisted instruction (CAI) had an effect on students' reading achievement. Subjects were 21 randomly selected fourth-grade students at D. S. Wentworth Elementary School on the south side of Chicago in a low-income neighborhood who received a year's exposure to a CAI program, and 21 randomly selected students at…

Donepezil improved memory in multiple sclerosis in a randomized clinical trial.

PubMed

Krupp, L B; Christodoulou, C; Melville, P; Scherl, W F; MacAllister, W S; Elkins, L E

2004-11-09

To determine the effect of donepezil in treating memory and cognitive dysfunction in multiple sclerosis (MS). This single-center double-blind placebo-controlled clinical trial evaluated 69 MS patients with cognitive impairment who were randomly assigned to receive a 24-week treatment course of either donepezil (10 mg daily) or placebo. Patients underwent neuropsychological assessment at baseline and after 24 weeks of treatment. The primary outcome was change in verbal learning and memory on the Selective Reminding Test (SRT). Secondary outcomes included other tests of cognitive function, patient-reported change in memory, and clinician-reported impression of cognitive change. Donepezil-treated patients showed significant improvement in memory performance on the SRT compared to placebo (p = 0.043). The benefit of donepezil remained significant after controlling for various covariates including age, Expanded Disability Status Scale, baseline SRT score, reading ability, MS subtype, and sex. Donepezil-treated patients did not show significant improvements on other cognitive tests, but were more than twice as likely to report memory improvement than those in the placebo group (p = 0.006). The clinician also reported cognitive improvement in almost twice as many donepezil vs placebo patients (p = 0.036). No serious adverse events related to study medication occurred, although more donepezil (34.3%) than placebo (8.8%) subjects reported unusual/abnormal dreams (p = 0.010). Donepezil improved memory in MS patients with initial cognitive impairment in a single center clinical trial. A larger multicenter investigation of donepezil in MS is warranted in order to more definitively assess the efficacy of this intervention.

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial.

PubMed

Spoelstra, Sandra L; Given, Charles W; Sikorskii, Alla; Coursaris, Constantinos K; Majumder, Atreyee; DeKoekkoek, Tracy; Schueller, Monica; Given, Barbara A

2016-06-01

This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Measures were administered at baseline, weekly (Weeks 1-8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n = 38) were satisfied. The differences between experimental and control groups' ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04; ES = 0.54) in the experimental group. Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice.

Reading aloud: does previous trial history modulate the joint effects of stimulus quality and word frequency?

PubMed

O'Malley, Shannon; Besner, Derek

2013-07-01

No one would argue with the proposition that how we process events in the world is strongly affected by our experience. Nonetheless, recent experience (e.g., from the previous trial) is typically not considered in the analysis of timed cognitive performance in the laboratory. Masson and Kliegl (2013) reported that, in the context of the lexical decision task, the nature of the previous trial strongly modulates the joint effects of word frequency and stimulus quality-a joint effect that is widely reported to be additive when averaged over trial history. In particular, their analysis suggests there may be no genuine additivity of these factors. Here we extended this line of investigation by reanalyzing data reported by O'Malley and Besner (2008) in which subjects read words and nonwords aloud, with word frequency and stimulus quality as manipulated factors. These factors are additive on reaction time in the standard analysis of variance. Contrary to Masson and Kliegl's finding for lexical decision, when previous trial history is taken into consideration, these 2 factors still do not interact. This suggests that, at least in the context of reading aloud, previous trial does not modulate how the effects of these 2 factors combine. Some implications are briefly noted. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Productive extension of semantic memory in school-aged children: Relations with reading comprehension and deployment of cognitive resources.

PubMed

Bauer, Patricia J; Blue, Shala N; Xu, Aoxiang; Esposito, Alena G

2016-07-01

We investigated 7- to 10-year-old children's productive extension of semantic memory through self-generation of new factual knowledge derived through integration of separate yet related facts learned through instruction or through reading. In Experiment 1, an experimenter read the to-be-integrated facts. Children successfully learned and integrated the information and used it to further extend their semantic knowledge, as evidenced by high levels of correct responses in open-ended and forced-choice testing. In Experiment 2, on half of the trials, the to-be-integrated facts were read by an experimenter (as in Experiment 1) and on half of the trials, children read the facts themselves. Self-generation performance was high in both conditions (experimenter- and self-read); in both conditions, self-generation of new semantic knowledge was related to an independent measure of children's reading comprehension. In Experiment 3, the way children deployed cognitive resources during reading was predictive of their subsequent recall of newly learned information derived through integration. These findings indicate self-generation of new semantic knowledge through integration in school-age children as well as relations between this productive means of extension of semantic memory and cognitive processes engaged during reading. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Productive Extension of Semantic Memory in School-aged Children: Relations with Reading Comprehension and Deployment of Cognitive Resources

PubMed Central

Bauer, Patricia J.; Blue, Shala N.; Xu, Aoxiang; Esposito, Alena G.

2016-01-01

We investigated 7- to 10-year-old children’s productive extension of semantic memory through self-generation of new factual knowledge derived through integration of separate yet related facts learned through instruction or through reading. In Experiment 1, an experimenter read the to-be-integrated facts. Children successfully learned and integrated the information and used it to further extend their semantic knowledge, as evidenced by high levels of correct responses in open-ended and forced-choice testing. In Experiment 2, on half of the trials, the to-be-integrated facts were read by an experimenter (as in Experiment 1) and on half of the trials, children read the facts themselves. Self-generation performance was high in both conditions (experimenter- and self-read); in both conditions, self-generation of new semantic knowledge was related to an independent measure of children’s reading comprehension. In Experiment 3, the way children deployed cognitive resources during reading was predictive of their subsequent recall of newly learned information derived through integration. These findings indicate self-generation of new semantic knowledge through integration in school-age children as well as relations between this productive means of extension of semantic memory and cognitive processes engaged during reading. PMID:27253263

Reading Success and Failure among Chinese Children.

ERIC Educational Resources Information Center

Hsu, Chen-chin

Drawing on a cross-national study of children's reading, a study examined the correlates of reading success and failure in Taiwan. Subjects, 240 randomly selected Taipei fifth graders, were administered a reading test, cognitive test, and mathematics achievement test. A structured interview with each child's mother and classroom behavior…

Comparing the impact on Latinos of a depression brochure and an entertainment-education depression fotonovela.

PubMed

Cabassa, Leopoldo J; Oh, Hans; Humensky, Jennifer L; Unger, Jennifer B; Molina, Gregory B; Baron, Melvin

2015-03-01

The purpose was to evaluate the impact of a depression fotonovela in increasing knowledge of depression symptoms and treatments and reducing stigma among Latinos. Data were from a randomized controlled trial in which Latinos from adult schools (N=132) were assigned to receive the fotonovela or a depression brochure and were assessed on knowledge and stigma measures before and after reading the material and one month later. Random-effects linear and logistic regression models assessed changes within and between groups. No significant differences were found between groups in symptom knowledge, social distance, and perceptions of dangerousness. Gains in depression treatment knowledge were significantly greater for the fotonovela than for the depression brochure group. Findings suggest that a depression fotonovela informed by an entertainment-education approach is a useful tool for improving depression treatment knowledge among Latinos but is limited in improving symptom knowledge and reducing stigma related to social distance and perceptions of dangerousness.

Comparing the Impact on Latinos of a Depression Brochure and an Entertainment-Education Depression Fotonovela

PubMed Central

Cabassa, Leopoldo J.; Oh, Hans; Humensky, Jennifer L; Unger, Jennifer B.; Molina, Gregory B.; Baron, Melvin

2015-01-01

Objective The purpose was to evaluate the impact of a depression fotonovela in increasing knowledge of depression symptoms and treatments and reducing stigma among Latinos. Methods Data were from a randomized controlled trial in which Latinos from adult schools (N=132) were assigned to receive the fotonovela or a depression brochure and were assessed on knowledge and stigma measures before and after reading the material and one month later. Random-effects linear and logistic regression models assessed changes within and between groups. Results No significant differences were found between groups in symptom knowledge, social distance, and perceptions of dangerousness. Gains in depression treatment knowledge were significantly greater for the fotonovela than for the depression brochure group. Conclusions Findings suggest that a depression fotonovela informed by an entertainment-education approach is a useful tool for improving depression treatment knowledge among Latinos but is limited in improving symptom knowledge and reducing stigma related to social distance and perceptions of dangerousness. PMID:25727121

Trial type mixing substantially reduces the response set effect in the Stroop task.

PubMed

Hasshim, Nabil; Parris, Benjamin A

2017-03-20

The response set effect refers to the finding that an irrelevant incongruent colour-word produces greater interference when it is one of the response options (referred to as a response set trial), compared to when it is not (a non-response set trial). Despite being a key effect for models of selective attention, the magnitude of the effect varies considerably across studies. We report two within-subjects experiments that tested the hypothesis that presentation format modulates the magnitude of the response set effect. Trial types (e.g. response set, non-response set, neutral) were either presented in separate blocks (pure) or in blocks containing trials from all conditions presented randomly (mixed). In the first experiment we show that the response set effect is substantially reduced in the mixed block context as a result of a decrease in RTs to response set trials. By demonstrating the modulation of the response set effect under conditions of trial type mixing we present evidence that is difficult for models of the effect based on strategic, top-down biasing of attention to explain. In a second experiment we tested a stimulus-driven account of the response set effect by manipulating the number of colour-words that make up the non-response set of distractors. The results show that the greater the number of non-response set colour concepts, the smaller the response set effect. Alternative accounts of the data and its implications for research debating the automaticity of reading are discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

A booklet on participants' rights to improve consent for clinical research: a randomized trial.

PubMed

Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

2012-01-01

Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.

A Booklet on Participants’ Rights to Improve Consent for Clinical Research: A Randomized Trial

PubMed Central

Benatar, Jocelyne R.; Mortimer, John; Stretton, Matthew; Stewart, Ralph A. H.

2012-01-01

Objective Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. Methods 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants’ rights. A booklet designed to provide information on participants’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Results Information related to participants’ rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). Conclusions A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials. PMID:23094034

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Effectiveness of Various Methods of Teaching Proper Inhaler Technique.

PubMed

Axtell, Samantha; Haines, Seena; Fairclough, Jamie

2017-04-01

To compare the effectiveness of 4 different instructional interventions in training proper inhaler technique. Randomized, noncrossover trial. Health fair and indigent clinic. Inhaler-naive adult volunteers who spoke and read English. Subjects were assigned to complete the following: (1) read a metered dose inhaler (MDI) package insert pamphlet, (2) watch a Centers for Disease Control and Prevention (CDC) video demonstrating MDI technique, (3) watch a YouTube video demonstrating MDI technique, or (4) receive direct instruction of MDI technique from a pharmacist. Inhaler use competency (completion of all 7 prespecified critical steps). Of the 72 subjects, 21 (29.2%) demonstrated competent inhaler technique. A statistically significant difference between pharmacist direct instruction and the remaining interventions, both combined ( P < .0001) and individually ( P ≤ .03), was evident. No statistically significant difference was detected among the remaining 3 intervention groups. Critical steps most frequently omitted or improperly performed were exhaling before inhalation and holding of breath after inhalation. A 2-minute pharmacist counseling session is more effective than other interventions in successfully educating patients on proper inhaler technique. Pharmacists can play a pivotal role in reducing the implications of improper inhaler use.

Mental exercises for cognitive function: clinical evidence.

PubMed

Kawashima, Ryuta

2013-01-01

The purpose of this study was to examine the beneficial effects of a new cognitive intervention program designed for the care and prevention of dementia, namely Learning Therapy. The training program used systematized basic problems in arithmetic and Japanese language as training tasks. In study 1, 16 individuals in the experimental group and 16 in the control group were recruited from a nursing home. In both groups, all individuals were clinically diagnosed with senile dementia of the Alzheimer type. In study 2, we performed a single-blind, randomized controlled trial in our cognitive intervention program of 124 community-dwelling seniors. In both studies, the daily training program using reading and arithmetic tasks was carried out approximately 5 days a week, for 15 to 20 minutes a day in the intervention groups. Neuropsychological measures were determined simultaneously in the groups both prior to and after six months of the intervention. The results of our investigations indicate that our cognitive intervention using reading and arithmetic problems demonstrated a transfer effect and they provide convincing evidence that cognitive training maintains and improves the cognitive functions of dementia patients and healthy seniors.

Modulation of additive and interactive effects in lexical decision by trial history.

PubMed

Masson, Michael E J; Kliegl, Reinhold

2013-05-01

Additive and interactive effects of word frequency, stimulus quality, and semantic priming have been used to test theoretical claims about the cognitive architecture of word-reading processes. Additive effects among these factors have been taken as evidence for discrete-stage models of word reading. We present evidence from linear mixed-model analyses applied to 2 lexical decision experiments indicating that apparent additive effects can be the product of aggregating over- and underadditive interaction effects that are modulated by recent trial history, particularly the lexical status and stimulus quality of the previous trial's target. Even a simple practice effect expressed as improved response speed across trials was powerfully modulated by the nature of the previous target item. These results suggest that additivity and interaction between factors may reflect trial-to-trial variation in stimulus representations and decision processes rather than fundamental differences in processing architecture.

How Should Debriefing Be Undertaken in Web-Based Studies? Findings From a Randomized Controlled Trial

PubMed Central

Kypri, Kypros; Wilson, Amanda

2012-01-01

Background Internet research may raise older ethical issues in new forms or pose new issues. It has been recommended that debriefing information online be kept very short, with further information including study results made available if requested by participants. There are no empirical studies that compare possible alternative methods of debriefing in online studies. Objective To undertake a randomized controlled trial evaluating how to implement the recommended approach by assessing the effects of two different approaches on accessing of additional information. Methods All 11,943 participants in the Effects of Study Design and Allocation (ESDA) study, which employed deception, were randomly assigned to one of two methods of debriefing: Group A received the debriefing information in the body of an email with links to protocol and results pages; Group B was presented with these links after clicking on an initial link in the body of the email to view the debriefing information on a website. Outcomes assessed were the proportions clicking on the links to the protocol and results summary and the time spent on these pages by those accessing them. Results The group who were presented with no debriefing information in the body of the email and went to a website for this information (Group B) were approximately twice as likely to subsequently access the protocol and the results summary. These differences between the two groups were highly statistically significant. Although these differences are clear, the overall proportions accessing such information were low, and there were no differences in mean time spent reading these pages. Only one quarter of Group B actually accessed debriefing information. Conclusions In circumstances where the uptake of fuller information on study design, methods, and findings is deemed important, debriefing information may be better provided via a link and not included in the body of an email. Doing so may, however, reduce the extent of receiving any debriefing information at all. There is a wider need for high quality empirical studies to inform ethical evaluations. Trial Registration Australian New Zealand Clinical Trials Registry, ACTRN12610000846022 (http://www.anzctr.org.au/) PMID:23160103

Expanding the Boundaries of Shared Book Reading: E-Books and Printed Books in Parent-Child Reading as Support for Children's Language

ERIC Educational Resources Information Center

Korat, Ofra; Shamir, Adina; Heibal, Shani

2013-01-01

Early shared book reading activities are considered to be a promising context for supporting young children's language development. Ninety low socioeconomic status preschoolers and their mothers were randomly assigned to one of three groups: (1) e-book reading; (2) printed book reading; (3) regular kindergarten literacy program (control). Mothers…

Reading Electronic and Printed Books with and without Adult Instruction: Effects on Emergent Reading

ERIC Educational Resources Information Center

Segal-Drori, Ora; Korat, Ofra; Shamir, Adina; Klein, Pnina S.

2010-01-01

The effects of electronic book (e-book) and printed book reading on children's emergent reading with and without adult instruction were investigated. One hundred twenty-eight 5- to 6-year-old kindergarten children from low SES families were randomly assigned to one of four groups (32 children each): (1) independently reading the e-book (EB); (2)…

Effect of an Online Video-Based Intervention to Increase HIV Testing in Men Who Have Sex with Men in Peru

PubMed Central

Blas, Magaly M.; Alva, Isaac E.; Carcamo, Cesar P.; Cabello, Robinson; Goodreau, Steven M.; Kimball, Ann M.; Kurth, Ann E.

2010-01-01

Background Although many men who have sex with men (MSM) in Peru are unaware of their HIV status, they are frequent users of the Internet, and can be approached by that medium for promotion of HIV testing. Methods We conducted an online randomized controlled trial to compare the effect of HIV-testing motivational videos versus standard public health text, both offered through a gay website. The videos were customized for two audiences based on self-identification: either gay or non-gay men. The outcomes evaluated were ‘intention to get tested’ and ‘HIV testing at the clinic.’ Findings In the non-gay identified group, 97 men were randomly assigned to the video-based intervention and 90 to the text-based intervention. Non-gay identified participants randomized to the video-based intervention were more likely to report their intention of getting tested for HIV within the next 30 days (62.5% vs. 15.4%, Relative Risk (RR): 2.77, 95% Confidence Interval (CI): 1.42–5.39). After a mean of 125.5 days of observation (range 42–209 days), 11 participants randomized to the video and none of the participants randomized to text attended our clinic requesting HIV testing (p = 0.001). In the gay-identified group, 142 men were randomized to the video-based intervention and 130 to the text-based intervention. Gay-identified participants randomized to the video were more likely to report intentions of getting an HIV test within 30 days, although not significantly (50% vs. 21.6%, RR: 1.54, 95% CI: 0.74–3.20). At the end of follow up, 8 participants who watched the video and 10 who read the text visited our clinic for HIV testing (Hazard Ratio: 1.07, 95% CI: 0.40–2.85). Conclusion This study provides some evidence of the efficacy of a video-based online intervention in improving HIV testing among non-gay-identified MSM in Peru. This intervention may be adopted by institutions with websites oriented to motivate HIV testing among similar MSM populations. Trial registration Clinicaltrials.gov NCT00751192 PMID:20454667

Effects of physical activity on schoolchildren's academic performance: The Active Smarter Kids (ASK) cluster-randomized controlled trial.

PubMed

Resaland, Geir K; Aadland, Eivind; Moe, Vegard Fusche; Aadland, Katrine N; Skrede, Turid; Stavnsbo, Mette; Suominen, Laura; Steene-Johannessen, Jostein; Glosvik, Øyvind; Andersen, John R; Kvalheim, Olav M; Engelsrud, Gunn; Andersen, Lars B; Holme, Ingar M; Ommundsen, Yngvar; Kriemler, Susi; van Mechelen, Willem; McKay, Heather A; Ekelund, Ulf; Anderssen, Sigmund A

2016-10-01

To investigate the effect of a seven-month, school-based cluster-randomized controlled trial on academic performance in 10-year-old children. In total, 1129 fifth-grade children from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention group or to the control group. The children in the 28 intervention schools participated in a physical activity intervention between November 2014 and June 2015 consisting of three components: 1) 90min/week of physically active educational lessons mainly carried out in the school playground; 2) 5min/day of physical activity breaks during classroom lessons; 3) 10min/day physical activity homework. Academic performance in numeracy, reading and English was measured using standardized Norwegian national tests. Physical activity was measured objectively by accelerometry. We found no effect of the intervention on academic performance in primary analyses (standardized difference 0.01-0.06, p>0.358). Subgroup analyses, however, revealed a favorable intervention effect for those who performed the poorest at baseline (lowest tertile) for numeracy (p=0.005 for the subgroup∗group interaction), compared to controls (standardized difference 0.62, 95% CI 0.19-1.07). This large, rigorously conducted cluster RCT in 10-year-old children supports the notion that there is still inadequate evidence to conclude that increased physical activity in school enhances academic achievement in all children. Still, combining physical activity and learning seems a viable model to stimulate learning in those academically weakest schoolchildren. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

De-stigmatising human papillomavirus in the context of cervical cancer: a randomised controlled trial.

PubMed

Kwan, Tracy T C; Tam, Kar-Fai; Lee, Peter W H; Lo, Sue S T; Chan, Karen K L; Ngan, Hextan Y S

2010-12-01

To identify the components of a human papillomavirus (HPV) message contributing to reducing the stigma of HPV in cervical cancer. 294 ethnic Chinese women attending a community-based clinic in Hong Kong were randomly allocated to read one of three written HPV messages: Group 'lr+hrHPV': low-risk and high-risk HPVs facts, Group 'hrHPV': high-risk HPV facts only and Group 'ds+hrHPV': high-risk HPV facts and de-stigmatising components, namely being anti-stereotypical, motivational and low in complexity. Main outcome measures were high-risk HPV-related sexual stigma, knowledge, attitude towards message, and intention to be HPV-tested measured by self-administered questionnaires immediately before and after reading. Message allocation had a significant effect on sexual stigma (F = 5.219, p = 0.006). Participants who read message ds+hrHPV showed the least stigma, and were significantly less likely to believe that high-risk HPV infection implicated promiscuity, non-monogamy or that monogamy offered complete protection against high-risk HPV. The genital HPV-focused message was more stigmatising than cervical cancer-focused messages. Of all participants, 93% (237/254) and 97% (260/269) indicated a positive intention to be HPV-tested before and after reading, respectively. There were no between-group differences noted in terms of knowledge and intention to be HPV-tested before or after reading. Our findings show that an HPV message containing specific de-stigmatising components may reduce public stigma towards high-risk HPV. Also, focusing solely on high-risk HPV in the context of cervical cancer helps to avoid the stigmatising effect of genital warts from tainting perceptions about high-risk HPV infection. Copyright © 2010 John Wiley & Sons, Ltd.

Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus.

PubMed

Connor, Jason T; Elm, Jordan J; Broglio, Kristine R

2013-08-01

We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping. The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design. The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment. When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size. Copyright © 2013 Elsevier Inc. All rights reserved.

Academic Outcomes 2 Years After Working Memory Training for Children With Low Working Memory: A Randomized Clinical Trial.

PubMed

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, 0.25-0.62]) and 12 months (effect size, 0.49 [95% CI, 0.28-0.70]), but not at 24 months. There were no benefits to any other outcomes; in fact, the math scores of the children in the intervention arm were worse at 2 years (mean difference, -3.0 [95% CI, -5.4 to -0.7]; P = .01). Intervention costs were A$1035 per child. Working memory screening of children 6 to 7 years of age is feasible, and an adaptive working memory training program may temporarily improve visuospatial short-term memory. Given the loss of classroom time, cost, and lack of lasting benefit, we cannot recommend population-based delivery of Cogmed within a screening paradigm. anzctr.org.au Identifier: ACTRN12610000486022.

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

PubMed

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

2015-02-05

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

A Randomised Controlled Trial of the Use of a Piece of Commercial Software for the Acquisition of Reading Skills

ERIC Educational Resources Information Center

Khan, Muhammad Ahmad; Gorard, Stephen

2012-01-01

We report here the overall results of a cluster randomised controlled trial of the use of computer-aided instruction with 672 Year 7 pupils in 23 secondary school classes in the north of England. A new piece of commercial software, claimed on the basis of publisher testing to be effective in improving reading after just six weeks of use in the…

Perspectives on the Impact of the 1994 Trial State Assessments: State Assessment Directors, State Mathematics Specialists, and State Reading Specialists.

ERIC Educational Resources Information Center

Hartka, Liz; Stancavage, Fran

This paper is the fourth in a series prepared for the National Academy of Education on the evaluation of the National Assessment of Educational Progress Trial State Assessment (TSA) and the impact of reporting TSA results. This paper provides a perspective on the last of the TSAs, an assessment of fourth-grade reading that was carried out in 44…

Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial.

PubMed

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

2013-01-01

Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. We conducted a double-blind (de facto masking) randomized controlled trial using a popular brain training game (Brain Age) and a popular puzzle game (Tetris). Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability). Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed) in the healthy young adults. Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields. UMIN Clinical Trial Registry 000005618.

The Random Forests Statistical Technique: An Examination of Its Value for the Study of Reading

ERIC Educational Resources Information Center

Matsuki, Kazunaga; Kuperman, Victor; Van Dyke, Julie A.

2016-01-01

Studies investigating individual differences in reading ability often involve data sets containing a large number of collinear predictors and a small number of observations. In this article, we discuss the method of Random Forests and demonstrate its suitability for addressing the statistical concerns raised by such data sets. The method is…

The Effect of Departmentalization on the Reading Achievement of Sixth-Grade Students.

ERIC Educational Resources Information Center

Harris, Mary B.

A study examined whether departmentalization affected the reading achievement of sixth-grade students attending a Chicago public school. A random sample of 30 students was chosen from a group of 53 who received instruction in a departmentalized program. A second random sample of 30 was selected from a total of 54 students who received instruction…

Influence of mono-axis random vibration on reading activity.

PubMed

Bhiwapurkar, M K; Saran, V H; Harsha, S P; Goel, V K; Berg, Mats

2010-01-01

Recent studies on train passengers' activities found that many passengers were engaged in some form of work, e.g., reading and writing, while traveling by train. A majority of the passengers reported that their activities were disturbed by vibrations or motions during traveling. A laboratory study was therefore set up to study how low-frequency random vibrations influence the difficulty to read. The study involved 18 healthy male subjects of 23 to 32 yr of age group. Random vibrations were applied in the frequency range (1-10 Hz) at 0.5, 1.0 and 1.5 m/s(2) rms amplitude along three directions (longitudinal, lateral and vertical). The effect of vibration on reading activity was investigated by giving a word chain in two different font types (Times New Roman and Arial) and three different sizes (10, 12 and 14 points) of font for each type. Subjects performed reading tasks under two sitting positions (with backrest support and leaning over a table). The judgments of perceived difficulty to read were rated using 7-point discomfort judging scale. The result shows that reading difficulty increases with increasing vibration magnitudes and found to be maximum in longitudinal direction, but with leaning over a table position. In comparison with Times New Roman type and sizes of font, subjects perceived less difficulty with Arial type for all font sizes under all vibration magnitude.

Reading Intervention for Poor Readers at the Transition to Secondary School

ERIC Educational Resources Information Center

Clarke, Paula J.; Paul, Shirley-Anne S.; Smith, Glynnis; Snowling, Margaret J.; Hulme, Charles

2017-01-01

This study evaluated two 20-week reading interventions for pupils entering secondary school with reading difficulties. The interventions were delivered by trained teaching assistants (three 35-min sessions per week). 287 pupils (ages 11-13) from 27 schools were randomly allocated to three groups: reading intervention (targeting word recognition…

A Comparison of Responsive Interventions on Kindergarteners' Early Reading Achievement

ERIC Educational Resources Information Center

Little, Mary E.; Rawlinson, D'Ann; Simmons, Deborah C.; Kim, Minjung; Kwok, Oi-man; Hagan-Burke, Shanna; Simmons, Leslie E.; Fogarty, Melissa; Oslund, Eric; Coyne, Michael D.

2012-01-01

This study compared the effects of Tier 2 reading interventions that operated in response-to-intervention contexts. Kindergarten children (N = 90) who were identified as at risk for reading difficulties were stratified by school and randomly assigned to receive (a) Early Reading Intervention (ERI; Pearson/Scott Foresman, 2004) modified in response…

Examining the Relationships of Component Reading Skills to Reading Comprehension in Struggling Adult Readers

ERIC Educational Resources Information Center

Tighe, Elizabeth L.; Schatschneider, Christopher

2016-01-01

The current study employed a meta-analytic approach to investigate the relative importance of component reading skills to reading comprehension in struggling adult readers. A total of 10 component skills were consistently identified across 16 independent studies and 2,707 participants. Random effects models generated 76 predictor-reading…

Switch-On Effectiveness Trial: Evaluation Report and Executive Summary

ERIC Educational Resources Information Center

Patel, Rakhee; Jabin, Nico; Bussard, Loraine; Cartagena, Javiera; Haywood, Sarah; Lumpkin, Michael

2017-01-01

Switch-on is an intensive, targeted literacy intervention that aims to improve the reading skills of pupils who are struggling with literacy. There are two versions of the intervention: Switch-on Reading and Switch-on Reading and Writing. Both involve specially trained Teaching Assistants (TAs) delivering a tailored programme of literacy support…

Relations between CBM (Oral Reading and Maze) and Reading Comprehension on State Achievement Tests: A Meta-Analysis

ERIC Educational Resources Information Center

Shin, Jaehyun

2017-01-01

The purpose of this study was to examine the validity of two widely used Curriculum-Based Measurement (CBM) in reading--oral reading and maze task--in relation to reading comprehension on state tests using a meta-analysis. A total of 61 studies (132 correlations) were identified across Grades 1 to 10. A random-effects meta-analysis was conducted…

The Relationship between Prosodic Oral Reading Assessments and Standards-Based Reading Assessment in a 2nd Grade Classroom

ERIC Educational Resources Information Center

Kariuki, Patrick; Baxter, Andrew

2011-01-01

The purpose of this study was to examine the relationship between prosodic oral reading and overall reading comprehension of second grade students. The sample consisted of ten students who were randomly selected from a second grade classroom. The students read aloud from the book "Bedtime for Frances" by Lillian and Russell Hoban for a…

The effects of two health information texts on patient recognition memory: a randomized controlled trial.

PubMed

Freed, Erin; Long, Debra; Rodriguez, Tonantzin; Franks, Peter; Kravitz, Richard L; Jerant, Anthony

2013-08-01

To compare the effects of two health information texts on patient recognition memory, a key aspect of comprehension. Randomized controlled trial (N=60), comparing the effects of experimental and control colorectal cancer (CRC) screening texts on recognition memory, measured using a statement recognition test, accounting for response bias (score range -0.91 to 5.34). The experimental text had a lower Flesch-Kincaid reading grade level (7.4 versus 9.6), was more focused on addressing screening barriers, and employed more comparative tables than the control text. Recognition memory was higher in the experimental group (2.54 versus 1.09, t=-3.63, P=0.001), including after adjustment for age, education, and health literacy (β=0.42, 95% CI: 0.17, 0.68, P=0.001), and in analyses limited to persons with college degrees (β=0.52, 95% CI: 0.18, 0.86, P=0.004) or no self-reported health literacy problems (β=0.39, 95% CI: 0.07, 0.71, P=0.02). An experimental CRC screening text improved recognition memory, including among patients with high education and self-assessed health literacy. CRC screening texts comparable to our experimental text may be warranted for all screening-eligible patients, if such texts improve screening uptake. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of an educational video as an instrument to refresh and reinforce the learning of a nursing technique: a randomized controlled trial.

PubMed

Salina, Loris; Ruffinengo, Carlo; Garrino, Lorenza; Massariello, Patrizia; Charrier, Lorena; Martin, Barbara; Favale, Maria Santina; Dimonte, Valerio

2012-05-01

The Undergraduate Nursing Course has been using videos for the past year or so. Videos are used for many different purposes such as during lessons, nurse refresher courses, reinforcement, and sharing and comparison of knowledge with the professional and scientific community. The purpose of this study was to estimate the efficacy of the video (moving an uncooperative patient from the supine to the lateral position) as an instrument to refresh and reinforce nursing techniques. A two-arm randomized controlled trial (RCT) design was chosen: both groups attended lessons in the classroom as well as in the laboratory; a month later while one group received written information as a refresher, the other group watched the video. Both groups were evaluated in a blinded fashion. A total of 223 students agreed to take part in the study. The difference observed between those who had seen the video and those who had read up on the technique turned out to be an average of 6.19 points in favour of the first (P < 0.05). The results of the RCT demonstrated that students who had seen the video were better able to apply the technique, resulting in a better performance. The video, therefore, represents an important tool to refresh and reinforce previous learning.

Influence of oxytocin on emotion recognition from body language: A randomized placebo-controlled trial.

PubMed

Bernaerts, Sylvie; Berra, Emmely; Wenderoth, Nicole; Alaerts, Kaat

2016-10-01

The neuropeptide 'oxytocin' (OT) is known to play a pivotal role in a variety of complex social behaviors by promoting a prosocial attitude and interpersonal bonding. One mechanism by which OT is hypothesized to promote prosocial behavior is by enhancing the processing of socially relevant information from the environment. With the present study, we explored to what extent OT can alter the 'reading' of emotional body language as presented by impoverished biological motion point light displays (PLDs). To do so, a double-blind between-subjects randomized placebo-controlled trial was conducted, assessing performance on a bodily emotion recognition task in healthy adult males before and after a single-dose of intranasal OT (24 IU). Overall, a single-dose of OT administration had a significant effect of medium size on emotion recognition from body language. OT-induced improvements in emotion recognition were not differentially modulated by the emotional valence of the presented stimuli (positive versus negative) and also, the overall tendency to label an observed emotional state as 'happy' (positive) or 'angry' (negative) was not modified by the administration of OT. Albeit moderate, the present findings of OT-induced improvements in bodily emotion recognition from whole-body PLD provide further support for a link between OT and the processing of socio-communicative cues originating from the body of others. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The Effects of Two Health Information Texts on Patient Recognition Memory: A Randomized Controlled Trial

PubMed Central

Freed, Erin; Long, Debra; Rodriguez, Tonantzin; Franks, Peter; Kravitz, Richard L.; Jerant, Anthony

2013-01-01

Objective To compare the effects of two health information texts on patient recognition memory, a key aspect of comprehension. Methods Randomized controlled trial (N = 60), comparing the effects of experimental and control colorectal cancer (CRC) screening texts on recognition memory, measured using a statement recognition test, accounting for response bias (score range −0.91 to 5.34). The experimental text had a lower Flesch-Kincaid reading grade level (7.4 versus 9.6), was more focused on addressing screening barriers, and employed more comparative tables than the control text. Results Recognition memory was higher in the experimental group (2.54 versus 1.09, t= −3.63, P = 0.001), including after adjustment for age, education, and health literacy (β = 0.42, 95% CI 0.17, 0.68, P = 0.001), and in analyses limited to persons with college degrees (β = 0.52, 95% CI 0.18, 0.86, P = 0.004) or no self-reported health literacy problems (β = 0.39, 95% CI 0.07, 0.71, P = 0.02). Conclusion An experimental CRC screening text improved recognition memory, including among patients with high education and self-assessed health literacy. Practice Implications CRC screening texts comparable to our experimental text may be warranted for all screening-eligible patients, if such texts improve screening uptake. PMID:23541216

Cancer Patient and Survivor Research from the Cancer Information Service Research Consortium: A Preview of Three Large Randomized Trials and Initial Lessons Learned

PubMed Central

MARCUS, ALFRED C.; DIEFENBACH, MICHAEL A.; STANTON, ANNETTE L.; MILLER-HALEGOUA, SUZANNE N.; FLEISHER, LINDA; RAICH, PETER C.; MORRA, MARION E.; PEROCCHIA, ROSEMARIE SLEVIN; TRAN, ZUNG VU; BRIGHT, MARY ANNE

2014-01-01

Three large randomized trials are described from the Cancer Information Service Research Consortium (CISRC). Three web-based multimedia programs are being tested to help newly diagnosed prostate (Project 1) and breast cancer patients (Project 2) make informed treatment decisions and breast cancer patients prepare for life after treatment (Project 3). Project 3 is also testing a telephone callback intervention delivered by a cancer information specialist. All participants receive standard print material specific to each project. Preliminary results from the two-month follow-up interviews are reported for the initial wave of enrolled participants, most of whom were recruited from the Cancer Information Service (1-800-4-CANCER) telephone information program (Project 1 = 208, Project 2 = 340, Project 3 = 792). Self-reported use of the multimedia program was 51%, 52% and 67% for Projects 1–3, respectively. Self-reported use of the print materials (read all, most or some) was 90%, 85% and 83% for Projects 1–3, respectively. The callback intervention was completed by 92% of Project 3 participants. Among those using the CISRC interventions, perceived utility and benefit was high, and more than 90% would recommend them to other cancer patients. Five initial lessons learned are presented that may help inform future cancer communications research. PMID:23448232

Cancer patient and survivor research from the cancer information service research consortium: a preview of three large randomized trials and initial lessons learned.

PubMed

Marcus, Alfred C; Diefenbach, Michael A; Stanton, Annette L; Miller, Suzanne M; Fleisher, Linda; Raich, Peter C; Morra, Marion E; Perocchia, Rosemarie Slevin; Tran, Zung Vu; Bright, Mary Anne

2013-01-01

The authors describe 3 large randomized trials from the Cancer Information Service Research Consortium. Three web-based multimedia programs are being tested to help newly diagnosed prostate (Project 1) and breast cancer patients (Project 2) make informed treatment decisions and breast cancer patients prepare for life after treatment (Project 3). Project 3 also tests a telephone callback intervention delivered by a cancer information specialist. All participants receive standard print material specific to each project. Preliminary results from the 2-month follow-up interviews are reported for the initial wave of enrolled participants, most of whom were recruited from the Cancer Information Service (1-800-4-CANCER) telephone information program (Project 1: n =208; Project 2: n =340; Project 3: n =792). Self-reported use of the multimedia program was 51%, 52%, and 67% for Projects 1, 2, and 3, respectively. Self-reported use of the print materials (read all, most, or some) was 90%, 85%, and 83% for Projects 1, 2, and 3, respectively. The callback intervention was completed by 92% of Project 3 participants. Among those using the Cancer Information Service Research Consortium interventions, perceived usefulness and benefit was high, and more than 90% reported that they would recommend them to other cancer patients. The authors present 5 initial lessons learned that may help inform future cancer communications research.

[Transcultural prevention of alcohol-related disorders : effects of a culture- and migration-sensitive approach in elderly migrants with respect to attitudes and behavior: a cluster randomized controlled trial].

PubMed

Bermejo, Isaac; Frank, F; Komarahadi, F; Albicker, J; Ries, Z; Kriston, L; Härter, M

2015-07-01

For migrants who are older than 50, alcohol frequently becomes a problem. Simultaneously alcohol-related prevention measures only reach this group insufficiently. Therefore, a transcultural concept for preventing alcohol-related disorders in elderly (≥ 45 years) migrants has been developed. The transcultural concept, which consisted of a prevention event as well as a cultural and language-sensitive information booklet, was evaluated in a cluster-randomized controlled trial (n = 310 immigrants). As a control condition there was a prevention event with materials from Deutsche Hauptstelle für Suchtfragen (German Centre for Addiction Issues). Data were obtained before and after the event, as well as after 6 months. All materials were available both in German and in Russian, Italian, Spanish and Turkish. Directly after the event, as well as 6 months thereafter, the transcultural approach was rated significantly better than the general prevention event. 73.4 % of the participants read the cultural and migration-sensitive booklet, whereas only 21.2 % in the control condition (p = 0.0001). Furthermore, significantly more participants of the transcultural approach reported a reduced alcohol consumption (49.4 vs. 16.7 %; p = 0.004) after 6 months. The consideration of diversity with respect to cultural, migration-related, socio demographic und linguistic aspects improves the effectiveness of prevention measures.

Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial.

PubMed

Bunnapradist, S; Ciechanowski, K; West-Thielke, P; Mulgaonkar, S; Rostaing, L; Vasudev, B; Budde, K

2013-03-01

Phase III noninferiority trial examining efficacy and safety of converting stable renal transplant recipients from twice-daily tacrolimus to a novel extended-release once-daily tacrolimus formulation (LCPT) with a controlled agglomeration technology. Controls maintained tacrolimus twice daily. The primary efficacy endpoint was proportion of patients with efficacy failures (death, graft failure, locally read biopsy-proven acute rejection [BPAR], or loss to follow-up) within 12 months. Starting LCPT dose was 30% lower (15% for blacks) than preconversion tacrolimus dose; target trough levels were 4-15 ng/mL. A total of 326 patients were randomized; the mITT population (n = 162 each group) was similar demographically in the two groups. Mean daily dose of LCPT was significantly (p < 0.0001) lower than preconversion tacrolimus dose at each visit; mean trough levels between groups were similar. There were four efficacy failures in each group; safety outcomes were similar between groups. Frequency of premature study drug discontinuation was LCPT: 12% versus tacrolimus twice daily: 5% (p = 0.028). LCPT demonstrated noninferiority to tacrolimus twice daily in efficacy failure rates. LCPT may offer a safe and effective alternative for converting patients to a once-daily formulation. Compared to currently available tacrolimus formulation, LCPT requires lower doses to achieve target trough levels. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

The impact of cataract surgery on visual functioning, vision-related disability and psychological distress: a randomized controlled trial.

PubMed

Walker, Janine G; Anstey, Kaarin J; Hennessy, Michael P; Lord, Stephen R; von Sanden, Chwee

2006-11-01

Determine whether there are changes in visual functioning, vision-related disability, health status and mood after cataract surgery. 45 adults (mean age = 73.7 years) with bilateral cataract needing surgery for the first eye were recruited from public ophthalmology clinics. The Visual Functioning-14 survey assessed visual disability. Minimal angle of resolution tested visual acuity, and the Melbourne Edge Test examined contrast sensitivity. Demographic, psychological, health and medication use variables were examined. Participants were randomized to either an intervention or control arm. Controls were assessed on two occasions at a 3-month interval before having surgery. The intervention group was assessed 1-2 weeks before surgery and then reassessed 3 months after surgery. Visual functioning improved for those who had cataract surgery with better visual acuity in the better (P = 0.010) and worse (P = 0.028) eye compared with controls. The intervention group reported fewer difficulties with overall vision-related disability (P = 0.0001), reading (P = 0.004) and instrumental activities of daily living (P = 0.010) post-surgery compared with controls. People with improved depression scores (P = 0.048) after surgery had less difficulty with reading compared with those with unchanged or worsened depression scores. Cataract surgery did not improve health status. First eye cataract surgery is effective in improving outcomes in visual functioning and disability. Improved mood after surgery was related to less vision-related disability compared with unchanged or worse depression.

Reading aids for adults with low vision

PubMed Central

Virgili, Gianni; Acosta, Ruthy; Grover, Lori L; Bentley, Sharon A; Giacomelli, Giovanni

2014-01-01

Background The purpose of low-vision rehabilitation is to allow people to resume or to continue to perform daily living tasks, with reading being one of the most important. This is achieved by providing appropriate optical devices and special training in the use of residual-vision and low-vision aids, which range from simple optical magnifiers to high-magnification video magnifiers. Objectives To assess the effects of reading aids for adults with low vision. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 1), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE, (January 1950 to January 2013), EMBASE (January 1980 to January 2013), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to January 2013), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov/) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 31 January 2013. We searched the reference lists of relevant articles and used the Science Citation Index to find articles that cited the included studies and contacted investigators and manufacturers of low-vision aids. We handsearched the British Journal of Visual Impairment from 1983 to 1999 and the Journal of Visual Impairment and Blindness from 1976 to 1991. Selection criteria This review includes randomised and quasi-randomised trials in which any device or aid used for reading had been compared to another device or aid in people aged 16 or over with low vision as defined by the study investigators. Data collection and analysis At least two authors independently assessed trial quality and extracted data. Main results We included nine small studies with a cross-over-like design (181 people overall) and one study with three parallel arms (243 participants) in the review. All studies reported the primary outcome, results for reading speed. Two studies including 92 participants found moderate- or low-quality evidence suggesting that reading speed is higher with stand-mounted electronic devices or electronic devices with the camera mounted in a ‘mouse’ than with optical magnifiers, which in these trials were generally stand-mounted or, less frequently, hand-held magnifiers or microscopic lenses. In another study of 20 participants there was moderate-quality evidence that optical devices are better than head-mounted electronic devices (four types). There was low-quality evidence from three studies (93 participants) that reading using head-mounted electronic devices is slower than with stand-based electronic devices. The technology of electronic devices may have changed and improved since these studies were conducted. One study suggested no difference between a diffractive spectacle-mounted magnifier and either refractive (15 participants) or aplanatic (15 participants) magnifiers. One study of 10 people suggested that several overlay coloured filters were no better and possibly worse than a clear filter. A parallel-arm study including 243 participants with age-related macular degeneration found that custom or standard prism spectacles were no different from conventional reading spectacles, although the data did not allow precise estimates of performance to be made. Authors' conclusions There is insufficient evidence on the effect of different types of low-vision aids on reading performance. It would be necessary to investigate which patient characteristics predict performance with different devices, including costly electronic devices. Better-quality research should also focus on assessing sustained long-term use of each device. Authors of studies testing several devices on the same person should consider design and reporting issues related to their sequential presentation and to the cross-over-like study design. PMID:24154864

Constructing high complexity synthetic libraries of long ORFs using in vitro selection

NASA Technical Reports Server (NTRS)

Cho, G.; Keefe, A. D.; Liu, R.; Wilson, D. S.; Szostak, J. W.

2000-01-01

We present a method that can significantly increase the complexity of protein libraries used for in vitro or in vivo protein selection experiments. Protein libraries are often encoded by chemically synthesized DNA, in which part of the open reading frame is randomized. There are, however, major obstacles associated with the chemical synthesis of long open reading frames, especially those containing random segments. Insertions and deletions that occur during chemical synthesis cause frameshifts, and stop codons in the random region will cause premature termination. These problems can together greatly reduce the number of full-length synthetic genes in the library. We describe a strategy in which smaller segments of the synthetic open reading frame are selected in vitro using mRNA display for the absence of frameshifts and stop codons. These smaller segments are then ligated together to form combinatorial libraries of long uninterrupted open reading frames. This process can increase the number of full-length open reading frames in libraries by up to two orders of magnitude, resulting in protein libraries with complexities of greater than 10(13). We have used this methodology to generate three types of displayed protein library: a completely random sequence library, a library of concatemerized oligopeptide cassettes with a propensity for forming amphipathic alpha-helical or beta-strand structures, and a library based on one of the most common enzymatic scaffolds, the alpha/beta (TIM) barrel. Copyright 2000 Academic Press.

Feasibility and user perception of a fully automated push-based multiple-session alcohol intervention for university students: randomized controlled trial.

PubMed

Bendtsen, Marcus; Bendtsen, Preben

2014-06-23

In recent years, many electronic health behavior interventions have been developed in order to reach individuals with unhealthy behaviors, such as risky drinking. This is especially relevant for university students, many of whom are risky drinkers. This study explored the acceptability and feasibility in a nontreatment-seeking group of university students (including both risk and nonrisk drinkers), of a fully automated, push-based, multiple-session, alcohol intervention, comparing two modes of delivery by randomizing participants to receive the intervention either by SMS text messaging (short message service, SMS) or by email. A total of 5499 students at Luleå University in northern Sweden were invited to participate in a single-session alcohol assessment and feedback intervention; 28.04% (1542/5499) students completed this part of the study. In total, 29.44% (454/1542) of those participating in the single-session intervention accepted to participate further in the extended multiple-session intervention lasting for 4 weeks. The students were randomized to receive the intervention messages via SMS or email. A follow-up questionnaire was sent immediately after the intervention and 52.9% (240/454) responded. No difference was seen regarding satisfaction with the length and frequency of the intervention, regardless of the mode of delivery. Approximately 15% in both the SMS (19/136) and email groups (15/104) would have preferred the other mode of delivery. On the other hand, more students in the SMS group (46/229, 20.1%) stopped participating in the intervention during the 4-week period compared with the email group (10/193, 5.2%). Most students in both groups expressed satisfaction with the content of the messages and would recommend the intervention to a fellow student in need of reducing drinking. A striking difference was seen regarding when a message was read; 88.2% (120/136) of the SMS group read the messages within 1 hour in contrast to 45.2% (47/104) in the email group. In addition, 83.1% (113/136) in the SMS group stated that they read all or almost all the messages, compared with only 63.5% (66/104) in the email group. Based on the feedback from the students, an extended, multiple-session, push-based intervention seems to be a feasible option for students interested in additional support after a single-session alcohol intervention. SMS as a mode of delivery seems to have some advantages over email regarding when a message is read and the proportion of messages read. However, more students in the SMS group stopped the intervention than in the email group. Based on these promising findings, further studies comparing the effectiveness of single-session interventions with extended multiple-session interventions delivered separately or in combination are warranted.

A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-16-1-0726 TITLE: A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI PRINCIPAL...2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI 5b. GRANT...forthcoming, The current study addresses this need through a double blind, placebo- controlled , randomized clinical trial (RCT) of a group

Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT)

PubMed Central

2014-01-01

Background Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being. Methods/Design The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum. Clinic-based providers and researchers conducting chart abstraction and analysis are blinded. Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention. Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal, infant, and family-based outcomes. Trial registration ClinicalTrials.gov Identifier: NCT01901796 PMID:24597683

A randomized controlled trial of an early-intervention, computer-based literacy program to boost phonological skills in 4- to 6-year-old children.

PubMed

O'Callaghan, Paul; McIvor, Aimee; McVeigh, Claire; Rushe, Teresa

2016-12-01

Many school-based interventions are being delivered in the absence of evidence of effectiveness (Snowling & Hulme, 2011, Br. J. Educ. Psychol., 81, 1). This study sought to address this oversight by evaluating the effectiveness of the commonly used the Lexia Reading Core5 intervention, with 4- to 6-year-old pupils in Northern Ireland. A total of 126 primary school pupils in year 1 and year 2 were screened on the Phonological Assessment Battery 2nd Edition (PhAB-2). Children were recruited from the equivalent year groups to Reception and Year 1 in England and Wales, and Pre-kindergarten and Kindergarten in North America. A total of 98 below-average pupils were randomized (T0) to either an 8-week block (x¯ = 647.51 min, SD = 158.21) of daily access to Lexia Reading Core5 (n = 49) or a waiting-list control group (n = 49). Assessment of phonological skills was completed at post-intervention (T1) and at 2-month follow-up (T2) for the intervention group only. Analysis of covariance which controlled for baseline scores found that the Lexia Reading Core5 intervention group made significantly greater gains in blending, F(1, 95) = 6.50, p = .012, partial η 2  = .064 (small effect size) and non-word reading, F(1, 95) = 7.20, p = .009, partial η 2  = .070 (small effect size). Analysis of the 2-month follow-up of the intervention group found that all group treatment gains were maintained. However, improvements were not uniform among the intervention group with 35% failing to make progress despite access to support. Post-hoc analysis revealed that higher T0 phonological working memory scores predicted improvements made in phonological skills. An early-intervention, computer-based literacy program can be effective in boosting the phonological skills of 4- to 6-year-olds, particularly if these literacy difficulties are not linked to phonological working memory deficits. © 2016 The British Psychological Society.

Randomized Controlled Trial Comparing Transepithelial Corneal Cross-linking Using Iontophoresis with the Dresden Protocol in Progressive Keratoconus.

PubMed

Lombardo, Marco; Giannini, Daniela; Lombardo, Giuseppe; Serrao, Sebastiano

2017-06-01

To compare clinical outcomes of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) and standard corneal cross-linking (standard CL) for the treatment of progressive keratoconus 12 months after the operation. Prospective randomized controlled clinical trial. Thirty-four eyes of 25 participants with progressive keratoconus were randomized into T-ionto CL (22 eyes) or standard CL (12 eyes). T-ionto CL was performed using an iontophoresis device with dextran-free 0.1% riboflavin-5-phosphate solution with enhancers and by irradiating the cornea with a 10 mW/cm 2 ultraviolet A device for 9 minutes. Standard CL was performed according to the Dresden protocol. The primary outcome measure was stabilization of keratoconus after 12 months through analysis of maximum simulated keratometry readings (K max , diopters). Other outcome measures were corrected distance visual acuity (CDVA, logarithm of the minimum angle of resolution [logMAR]), manifest spherical equivalent refraction (D), central corneal thickness (CCT, micrometers) and endothelial cell density (ECD). Follow-up examinations were arranged at 3 and 7 days and 1, 3, 6, and 12 months. Twelve months after T-ionto CL and standard CL, K max on average flattened by -0.52±1.30 D (P = 0.06) and -0.82±1.20 D (P = 0.04), respectively. The mean change in CDVA was -0.10±0.12 logMAR (P = 0.003) and -0.03±0.06 logMAR (P = 0.10) after T-ionto CL and standard CL, respectively. The manifest spherical equivalent refraction changed on average by +0.71±1.44 D (P = 0.03) and +0.21±0.76 D (P = 0.38), respectively. The CCT and ECD measures did not change significantly in any group at 12 months. Significant differences in the outcome measures between treatments were found in the first week postoperatively. No complications occurred in the T-ionto CL group; 1 eye (8%) had sterile corneal infiltrates, which did not affect the final visual acuity, in the standard CL group. Significant visual and refractive improvements were found 12 months after T-ionto CL, though the average improvement in corneal topography readings was slightly lower than the Dresden protocol in the same period. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Assessing the Generalizability of Randomized Trial Results to Target Populations

PubMed Central

Stuart, Elizabeth A.; Bradshaw, Catherine P.; Leaf, Philip J.

2014-01-01

Recent years have seen increasing interest in and attention to evidence-based practices, where the “evidence” generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as “internal validity”), they do not always yield relevant information about the effects in a particular target population (known as “external validity”). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a pre-specified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of School-wide Positive Behavioral Interventions and Supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific populations unless they are confident of the similarity between the trial sample and that target population. PMID:25307417

Assessing the generalizability of randomized trial results to target populations.

PubMed

Stuart, Elizabeth A; Bradshaw, Catherine P; Leaf, Philip J

2015-04-01

Recent years have seen increasing interest in and attention to evidence-based practices, where the "evidence" generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as "internal validity"), they do not always yield relevant information about the effects in a particular target population (known as "external validity"). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a prespecified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of school-wide positive behavioral interventions and supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific populations unless they are confident of the similarity between the trial sample and that target population.

Effect of Delay on Search Decisions in a Task-Oriented Reading Environment

ERIC Educational Resources Information Center

Mañá, Amelia; Vidal-Abarca, Eduardo; Salmerón, Ladislao

2017-01-01

The goal of this study was to determine the effect of setting a delay between reading a text and answering comprehension questions on "when"-to-search and "what"-to-search decisions in a task-oriented reading environment. Fifty-five eighth-grade students were randomly divided into two groups. One group read one text, answered…

Tablet vs. Paper: The Effect on Learners' Reading Performance

ERIC Educational Resources Information Center

Dundar, Hakan; Akcayir, Murat

2012-01-01

The purpose of this study is to compare primary school 5th-class students' electronic text reading performance, reading speed and reading comprehension with tablet PCs and printed books. This study examined a sample of 20 students. The students were randomly divided into two groups, a control group and a treatment group. The control group students…

Miscue Analysis of Oral Reading among Less Proficient Readers in Primary Schools in Brunei Darussalam

ERIC Educational Resources Information Center

Hamid, Juliana Bte Haji Abdul; Abosi, Okechukwu

2011-01-01

Reading disability is the most common disability. At least one in five children has significant challenges learning to read. This study focused on the oral reading performance of 30 Year-Three students. The students were identified as less proficient readers from two randomly selected primary schools in Brunei Darussalam. The oral reading…

Impact of Intensive Summer Reading Intervention for Children with Reading Disabilities and Difficulties in Early Elementary School

ERIC Educational Resources Information Center

Christodoulou, Joanna A.; Cyr, Abigail; Murtagh, Jack; Chang, Patricia; Lin, Jiayi; Guarino, Anthony J.; Hook, Pamela; Gabrieli, John D. E.

2017-01-01

Efficacy of an intensive reading intervention implemented during the nonacademic summer was evaluated in children with reading disabilities or difficulties (RD). Students (ages 6-9) were randomly assigned to receive Lindamood-Bell's "Seeing Stars" program (n = 23) as an intervention or to a waiting-list control group (n = 24). Analysis…

Examining a Motivational Treatment and Its Impact on Adolescents' Reading Comprehension and Fluency

ERIC Educational Resources Information Center

Wolters, Christopher A.; Barnes, Marcia A.; Kulesz, Paulina A.; York, Mary; Francis, David J.

2017-01-01

The authors' purpose was to examine adolescents' reading motivation in relation to standardized assessments of reading comprehension and fluency. After a reading pretest, 60 ninth-grade students (M age = 14.9 years) were randomly assigned to two groups. Compared to those in the control condition, those administered brief oral feedback intended to…

The Effects of Differentiated Instruction and Enrichment Pedagogy on Reading Achievement in Five Elementary Schools

ERIC Educational Resources Information Center

Reis, Sally M.; McCoach, D. Betsy; Little, Catherine A.; Muller, Lisa M.; Kaniskan, R. Burcu

2011-01-01

This experimental study examined the effect of a differentiated, enriched reading program on students' oral reading fluency and comprehension using the schoolwide enrichment model-reading (SEM-R). Treatment and control conditions were randomly assigned to 63 teachers and 1,192 second through fifth grade students across five elementary schools.…

Hierarchy of evidence: differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures.

PubMed

Bhandari, Mohit; Tornetta, Paul; Ellis, Thomas; Audige, Laurent; Sprague, Sheila; Kuo, Jonathann C; Swiontkowski, Marc F

2004-01-01

There have been a number of non-randomized studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. However, there remains considerable debate about whether the results of non-randomized studies are consistent with the results of randomized, controlled trials. Given the economic burden of hip fractures, it remains essential to identify therapies to improve outcomes; however, whether data from non-randomized studies of an intervention should be used to guide patient care remains unclear. We aimed to determine whether the pooled results of mortality and revision surgery among non-randomized studies were similar to those of randomized trials in studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. We conducted a Medline search from 1969 to June 2002, identifying both randomized and non-randomized studies comparing internal fixation with arthroplasty in patients with femoral neck fractures. Additional strategies to identify relevant articles included Cochrane database, SCISEARCH, textbooks, annual meeting programs, and content experts. We abstracted information on mortality and revision rates in each study and compared the pooled results between non-randomized and randomized studies. In addition, we explored potential reasons for dissimilar results between the two study designs. We identified 140 citations that addressed the general topic of comparison of arthroplasty and internal fixation for hip fracture. Of these, 27 studies met the eligibility criteria, 13 of which were non-randomized studies and 14 of which were randomized trials. Mortality data was available in all 13 non-randomized studies ( n=3108 patients) and in 12 randomized studies ( n=1767 patients). Non-randomized studies overestimated the risk of mortality by 40% when compared with the results of randomized trials (relative risk 1.44 vs 1.04, respectively). Information on revision risk was available in 9 non-randomized studies ( n=2764 patients) and all 14 randomized studies ( n=1901 patients). Both estimates from non-randomized and randomized studies revealed a significant reduction in the risk of revision surgery with arthroplasty compared with internal fixation (relative risk 0.38 vs 0.23, respectively). The reduction in the risk of revision surgery with arthroplasty compared with internal fixation was 62% for non-randomized studies and 77% for randomized trials. Thus, non-randomized studies underestimated the relative benefit of arthroplasty by 19.5%. Non-randomized studies with point estimates of relative risk similar to the pooled estimate for randomized trials all controlled for patient age, gender, and fracture displacement in their comparisons of mortality. We were unable to identify reasons for differences in the revision rate results between the study designs. Similar to other reports in medical subspecialties, non-randomized studies provided results dissimilar to randomized trials of arthroplasty vs internal fixation for mortality and revision rates in patients with femoral neck fractures. Investigators should be aware of these discrepancies when evaluating the merits of alternative surgical interventions, especially when both randomized trials and non-randomized comparative studies are available.

Plasma-Generating Glucose Monitor Accuracy Demonstrated in an Animal Model

PubMed Central

Magarian, Peggy; Sterling, Bernhard

2009-01-01

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

Antihypertensive treatment decreases arterial stiffness at night but not during the day. Results from the Hypertension in the Very Elderly Trial.

PubMed

Bulpitt, Christopher J; Webb, Richard; Beckett, Nigel; Peters, Ruth; Cheek, Elizabeth; Anderson, Craig; Antikainen, Riitta; Staessen, Jan A; Rajkumar, Chakravarthi

2017-04-01

The main Hypertension in the Very Elderly Trial (HYVET) demonstrated a very marked reduction in cardiovascular events by treating hypertensive participants 80 years or older with a low dose, sustained release prescription of indapamide (indapamide SR, 1.5 mg) to which was added a low dose of an angiotensin converting enzyme inhibitor in two-thirds of cases (perindopril 2-4 mg). This report from the ambulatory blood pressure sub-study investigates whether changes in arterial stiffness and ambulatory blood pressure (BP) could both explain the benefits observed in the main trial. A total of 139 participants were randomized to placebo [67] and to active treatment [72] and had both day and night observations of BP and arterial stiffness as determined from the Q wave Korotkoff diastolic (QKD) interval. The QKD interval was 5.6 ms longer (p = 0.017) in the actively treated group at night than in the placebo group. This was not true for the more numerous daytime readings so that 24-h results were similar in the two groups. The QKD interval remained longer at night in the actively treated group even when adjusted for systolic pressure, heart rate and height. The reduced arterial stiffness at night may partly explain the marked benefits observed in the main trial.

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

The Impact of Intensive Reading Intervention on Level of Attention in Middle School Students.

PubMed

Roberts, Greg; Rane, Shruti; Fall, Anna-Mária; Denton, Carolyn A; Fletcher, Jack M; Vaughn, Sharon

2015-01-01

The purpose of the study was to estimate the impact of reading intervention on ratings of student attention over time. We used extant data from a longitudinal randomized study of a response-based reading intervention to fit a multiple-indicator, multilevel growth model. The sample at randomization was 54% male, 18% limited English proficient, 85% eligible for free or reduced-price lunch, 58% African American, and 32% Hispanic. Reading ability was measured by using the Woodcock-Johnson III Tests of Achievement. Attention was measured by using the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale. Findings indicate that intensive, response-based reading intervention over 3 years improved reading achievement and behavioral attention in middle school struggling readers, with treatment directly affecting reading, which in turn influenced attention. In the business-as-usual condition, there was no relation between improved reading and attention. The results are consistent with a correlated liabilities model of comorbidity. The results do not align with the inattention-as-cause hypothesis, which predicts that reading intervention should not affect attention. The findings do not support, but do not necessarily preclude, the phenocopy hypothesis. The results are especially pertinent for older students who may be inattentive partly because of years of struggling with reading.

The Impact of Intensive Reading Intervention on Level of Attention in Middle School Students

PubMed Central

Roberts, Greg; Rane, Shruti; Fall, Anna-Mária; Denton, Carolyn A.; Fletcher, Jack M.; Vaughn, Sharon

2014-01-01

Objective The purpose of the study was to estimate the impact of reading intervention on ratings of student attention over time. Method We used extant data from a longitudinal randomized study of a response-based reading intervention to fit a multiple-indicator, multilevel growth model. The sample at randomization was 54% male, 18% limited English proficient, 85% eligible for free or reduced-price lunch, 58% African American, and 32% Hispanic. Reading ability was measured by using the Woodcock-Johnson III Tests of Achievement. Attention was measured by using the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale. Results Findings indicate that intensive, response-based reading intervention over 3 years improved reading achievement and behavioral attention in middle school struggling readers, with treatment directly affecting reading, which in turn influenced attention. In the business-as-usual condition, there was no relation between improved reading and attention. Conclusions The results are consistent with a correlated liabilities model of comorbidity. The results do not align with the inattention-as-cause hypothesis, which predicts that reading intervention should not affect attention. The findings do not support, but do not necessarily preclude, the phenocopy hypothesis. The results are especially pertinent for older students who may be inattentive partly because of years of struggling with reading. PMID:24885289

Development and pilot‐testing of a Decision Aid for use among Chinese women facing breast cancer surgery

PubMed Central

Au, Angel H.Y.; Lam, Wendy W.T.; Chan, Miranda C.M.; Or, Amy Y.M.; Kwong, Ava; Suen, Dacita; Wong, Annie L.; Juraskova, Ilona; Wong, Teresa W.T.; Fielding, Richard

2011-01-01

Abstract Background  Women choosing breast cancer surgery encounter treatment decision‐making (TDM) difficulties, which can cause psychological distress. Decision Aids (DAs) may facilitate TDM, but there are no DAs designed for Chinese populations. We developed a DA for Chinese women newly diagnosed with breast cancer, for use during the initial surgical consultation. Aims  Conduct a pilot study to assess the DA acceptability and utility among Chinese women diagnosed with breast cancer. Methods  Women preferred the DA in booklet format. A booklet was developed and revised and evaluated in two consecutive pilot studies (P1 and P2). On concluding their initial diagnostic consultation, 95 and 38 Chinese women newly diagnosed with breast cancer received the draft and revised draft DA booklet, respectively. Four‐day post‐consultation, women had questionnaires read out to them and to which they responded assessing attitudes towards the DA and their understanding of treatment options. Results  The original DA was read/partially read by 66/22% (n = 84) of women, whilst the revised version was read/partially read by 74/16% (n = 35), including subliterate women (χ2 = 0.76, P = 0.679). Knowledge scores varied with the extent the booklet was read (P1: F = 12.68, d.f. 2, P < 0.001; P2: F = 3.744, d.f. 2, P = 0.034). The revised, shorter version was graphically rich and resulted in improved perceived utility, [except for the ‘treatment options’ (χ2 = 5.50, P = 0.019) and ‘TDM guidance’ (χ2 = 8.19, P = 0.004) sections] without increasing anxiety (F = 0.689, P = 0.408; F = 3.45, P = 0.073). Conclusion  The DA was perceived as acceptable and useful for most women. The DA effectiveness is currently being evaluated using a randomized controlled trial. PMID:21223468

Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials.

PubMed

Herman, Amir; Botser, Itamar Busheri; Tenenbaum, Shay; Chechick, Ahron

2009-09-01

The intention-to-treat principle implies that all patients who are randomized in a clinical trial should be analyzed according to their original allocation. This means that patients crossing over to another treatment group and patients lost to follow-up should be included in the analysis as a part of their original group. This principle is important for preserving the randomization scheme, which is the basis for correct inference in any randomized trial. In this study, we examined the use of the intention-to-treat principle in recently published orthopaedic clinical trials. We surveyed eight leading orthopaedic journals for randomized clinical trials published between January 2005 and August 2008. We determined whether the intention-to-treat principle was implemented and, if so, how it was used in each trial. Specifically, we ascertained which methods were used to account for missing data. Our search yielded 274 randomized clinical trials, and the intention-to-treat principle was used in ninety-six (35%) of them. There were significant differences among the journals with regard to the use of the intention-to-treat principle. The relative number of trials in which the principle was used increased each year. The authors adhered to the strict definition of the intention-to-treat principle in forty-five of the ninety-six studies in which it was claimed that this principle had been used. In forty-four randomized trials, patients who had been lost to follow-up were excluded from the final analysis; this practice was most notable in studies of surgical interventions. The most popular method of adjusting for missing data was the "last observation carried forward" technique. In most of the randomized clinical trials published in the orthopaedic literature, the investigators did not adhere to the stringent use of the intention-to-treat principle, with the most conspicuous problem being a lack of accounting for patients lost to follow-up. This omission might introduce bias to orthopaedic randomized clinical trials and their analysis.

Reporting of participant flow diagrams in published reports of randomized trials.

PubMed

Hopewell, Sally; Hirst, Allison; Collins, Gary S; Mallett, Sue; Yu, Ly-Mee; Altman, Douglas G

2011-12-05

Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all.

PubMed

Papageorgiou, Spyridon N; Antonoglou, Georgios N; Sándor, George K; Eliades, Theodore

2017-01-01

A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date.

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all

PubMed Central

Antonoglou, Georgios N.; Sándor, George K.; Eliades, Theodore

2017-01-01

A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date. PMID:28777820

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955–2013

PubMed Central

Armijo-Olivo, Susan; Cummings, Greta G.; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

Objectives To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. Methods We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Results Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955–2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. Conclusions The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed. PMID:29272315

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

PubMed

Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed.

A highly symmetrical 10 transistor 2-read/write dual-port static random access memory bitcell design in 28 nm high-k/metal-gate planar bulk CMOS technology

NASA Astrophysics Data System (ADS)

Ishii, Yuichiro; Tanaka, Miki; Yabuuchi, Makoto; Sawada, Yohei; Tanaka, Shinji; Nii, Koji; Lu, Tien Yu; Huang, Chun Hsien; Sian Chen, Shou; Tse Kuo, Yu; Lung, Ching Cheng; Cheng, Osbert

2018-04-01

We propose a highly symmetrical 10 transistor (10T) 2-read/write (2RW) dual-port (DP) static random access memory (SRAM) bitcell in 28 nm high-k/metal-gate (HKMG) planar bulk CMOS. It replaces the conventional 8T 2RW DP SRAM bitcell without any area overhead. It significantly improves the robustness of process variations and an asymmetric issue between the true and bar bitline pairs. Measured data show that read current (I read) and read static noise margin (SNM) are respectively boosted by +20% and +15 mV by introducing the proposed bitcell with enlarged pull-down (PD) and pass-gate (PG) N-channel MOSs (NMOSs). The minimum operating voltage (V min) of the proposed 256 kbit 10T DP SRAM is 0.53 V in the TT process, 25 °C under the worst access condition with read/write disturbances, and improved by 90 mV (15%) compared with the conventional one.

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

PubMed Central

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

Progressive addition spectacle lenses: Design preferences and head movements while reading

NASA Astrophysics Data System (ADS)

Preston, Julie Lynn

In a subjective preference study, two key progressive addition lens parameters, near zone width and corridor length, were varied in a double-masked, randomized, clinical trial of 49 patients. Each subject received a complete eye examination and a new frame. Each wore 6 pairs of lenses for one week at a time and completed questionnaires relating to vision, adaptation, and satisfaction. The preferred lens was identified from the three near zone width lenses and from the three corridor length lenses. Patient characteristics were analyzed for their effect on design preference. Satisfaction ratings following a brief experience with each design were compared to ratings after one week of wear in order to ascertain the predictability of initial impressions. One lens design appeared twice in the preference trial, providing an assessment of the repeatability of the rating instrument. The lens design with the widest near zone was rated significantly lower than the other near zone width designs for nearly every question relating to vision, adaptation, and satisfaction. This lens was also least preferred of all the designs. Preferences for corridor length were evenly distributed among the three designs. Of patient characteristics, years of progressive addition lens wear and gender significantly affected design preference in this population. Initial impressions were not predictive of satisfaction after a week of wear. The rating instrument was judged to have low repeatability. In the head movement portion of the study, 18 participants from the preference study wore the three near zone width designs while reading three paragraphs of varying print size. From a 20 second recording for each of three different paragraphs with each lens, measures of head rotation and posture were collected. The amplitude of head rotation was significantly affected by print size but not by lens design. The effective zone widths on the lenses scanned by the eyes and the locations of the reading levels were calculated from the head rotation and posture data. Effective zone widths were narrower than the contour plot widths for each condition.

Investigation of the contextual interference effect in the manipulation of the motor parameter of over-all force.

PubMed

Goodwin, J E; Meeuwsen, H J

1996-12-01

This investigation examined the contextual interference effect when manipulating over-all force in a golf-putting task. Undergraduate women (N = 30) were randomly assigned to a Random, Blocked-Random, or Blocked practice condition and practiced golf putting from distances of 2.43 m, 3.95 m, and 5.47 m during acquisition. Subjects in the Random condition practiced trials in a quasirandom sequence and those in the Blocked-Random condition practiced trials initially in a blocked sequence with the remainder of the trials practiced in a quasirandom sequence. In the Blocked condition subjects practiced trials in a blocked sequence. A 24-hr. transfer test consisted of 30 trials with 10 trials each from 1.67 m, 3.19 m, and 6.23 m. Transfer scores supported the Magill and Hall (1990) hypothesis that, when task variations involve learning parameters of a generalized motor program, the benefit of random practice over blocked practice would not be found.

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome.

PubMed

Peterson, P K; Pheley, A; Schroeppel, J; Schenck, C; Marshall, P; Kind, A; Haugland, J M; Lambrecht, L J; Swan, S; Goldsmith, S

1998-04-27

To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome. A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone. An outpatient clinical trials unit. Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76%] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment. Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits. At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial. Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.

Evaluation of a device for standardized measurements of reading performance in a prepresbyopic population.

PubMed

Arad, Tschingis; Baumeister, Martin; Bühren, Jens; Kohnen, Thomas

2017-04-20

Automated measurements of reading performance are required for clinical trials involving presbyopia-correcting surgery options. Repeatability of a testing device for reading (Salzburg Reading Desk) was evaluated in a prepresbyopic population. Subjective reading performance of 50 subjects divided into 2 age groups (23-30 years and 38-49 years) with distance-corrected eyes was investigated with different log-scaled reading charts. At study entry, refractive parameters were measured and distance visual acuity assessed. Two standardized binocular measurements were performed for each subject (32.24 ± 9.87 days apart [mean ± SD]). The repeatability of the tests was estimated using correlation coefficients, Wilcoxon signed-rank test, and Bland-Altman method. The test parameters at both maximum reading rate (MRR) measurements demonstrate a strong relationship of age group 2 subjects (correlation coefficient [r] = 0.74 p = 10-4) and of younger subjects (age group 1: r = 0.69, p = 10-4). Prepresbyopic subjects of age group 2 showed moderate results for near reading distance (r = 0.67, p = 10-4); by contrast, younger subjects had poorer results (r = 0.55, p = 10-3). The Wilcoxon signed-rank test revealed agreement between measurements and Bland-Altman plots showed a wide data spread for MRR and near reading distance in both groups. The device measures repeatedly selected reading performance parameters of near real world conditions, such as MRR, in prepresbyopic populations if several factors are taken into account. The option to choose preferred distance leads to more variance in measuring repeated reading performance. German Clinical Trials Register (DRKS) registration reference number: DRKS00000784.

Read clouds uncover variation in complex regions of the human genome

PubMed Central

Bishara, Alex; Liu, Yuling; Weng, Ziming; Kashef-Haghighi, Dorna; Newburger, Daniel E.; West, Robert; Sidow, Arend; Batzoglou, Serafim

2015-01-01

Although an increasing amount of human genetic variation is being identified and recorded, determining variants within repeated sequences of the human genome remains a challenge. Most population and genome-wide association studies have therefore been unable to consider variation in these regions. Core to the problem is the lack of a sequencing technology that produces reads with sufficient length and accuracy to enable unique mapping. Here, we present a novel methodology of using read clouds, obtained by accurate short-read sequencing of DNA derived from long fragment libraries, to confidently align short reads within repeat regions and enable accurate variant discovery. Our novel algorithm, Random Field Aligner (RFA), captures the relationships among the short reads governed by the long read process via a Markov Random Field. We utilized a modified version of the Illumina TruSeq synthetic long-read protocol, which yielded shallow-sequenced read clouds. We test RFA through extensive simulations and apply it to discover variants on the NA12878 human sample, for which shallow TruSeq read cloud sequencing data are available, and on an invasive breast carcinoma genome that we sequenced using the same method. We demonstrate that RFA facilitates accurate recovery of variation in 155 Mb of the human genome, including 94% of 67 Mb of segmental duplication sequence and 96% of 11 Mb of transcribed sequence, that are currently hidden from short-read technologies. PMID:26286554

Scaffolding Voluntary Summer Reading for Children in Grades 3 to 5: An Experimental Study

ERIC Educational Resources Information Center

Kim, James S.; White, Thomas G.

2008-01-01

The effects of a voluntary summer reading intervention with teacher and parent scaffolding were investigated in an experimental study. A total of 24 teachers and 400 children in Grades 3, 4, and 5 were randomly assigned to one of four experimental conditions: control, books only, books with oral reading scaffolding, and books with oral reading and…

Diagnostic electrocardiography in epidemiological studies of Chagas' disease: multicenter evaluation of a standardized method.

PubMed

Lázzari, J O; Pereira, M; Antunes, C M; Guimarães, A; Moncayo, A; Chávez Domínguez, R; Hernández Pieretti, O; Macedo, V; Rassi, A; Maguire, J; Romero, A

1998-11-01

An electrocardiographic recording method with an associated reading guide, designed for epidemiological studies on Chagas' disease, was tested to assess its diagnostic reproducibility. Six cardiologists from five countries each read 100 electrocardiographic (ECG) tracings, including 30 from chronic chagasic patients, then reread them after an interval of 6 months. The readings were blind, with the tracings numbered randomly for the first reading and renumbered randomly for the second reading. The physicians, all experienced in interpreting ECGs from chagasic patients, followed printed instructions for reading the tracings. Reproducibility of the readings was evaluated using the kappa (kappa) index for concordance. The results showed a high degree of interobserver concordance with respect to the diagnosis of normal vs. abnormal tracings (kappa = 0.66; SE 0.02). While the interpretations of some categories of ECG abnormalities were highly reproducible, others, especially those having a low prevalence, showed lower levels of concordance. Intraobserver concordance was uniformly higher than interobserver concordance. The findings of this study justify the use by specialists of the recording of readings method proposed for epidemiological studies on Chagas' disease, but warrant caution in the interpretation of some categories of electrocardiographic alterations.

Nonvolatile GaAs Random-Access Memory

NASA Technical Reports Server (NTRS)

Katti, Romney R.; Stadler, Henry L.; Wu, Jiin-Chuan

1994-01-01

Proposed random-access integrated-circuit electronic memory offers nonvolatile magnetic storage. Bits stored magnetically and read out with Hall-effect sensors. Advantages include short reading and writing times and high degree of immunity to both single-event upsets and permanent damage by ionizing radiation. Use of same basic material for both transistors and sensors simplifies fabrication process, with consequent benefits in increased yield and reduced cost.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

Interobserver agreement of interim and end-of-treatment 18F-FDG PET/CT in diffuse large B-cell lymphoma (DLBCL): impact on clinical practice and trials.

PubMed

Burggraaff, Coreline N; Cornelisse, Alexander C; Hoekstra, Otto S; Lugtenburg, Pieternella J; de Keizer, Bart; Arens, Anne I J; Celik, Filiz; Huijbregts, Julia E; De Vet, Henrica C W; Zijlstra, Josee M

2018-05-04

We aimed to assess the interobserver agreement of Interim PET (I-PET) and End-of-Treatment PET (EoT-PET) using the Deauville 5-point scale (DS) in first-line DLBCL patients. Methods: I-PET and EoT-PET scans of DLBCL patients were performed in the HOVON84 study (2007-2012), an international multicenter randomized controlled trial. Patients received R-CHOP14 and were randomized to receive rituximab intensification in the first 4 cycles or not. I-PET was made after 4 cycles (for observational purposes), and EoT-PET scan after 6 or 8 cycles. Two independent central reviewers retrospectively scored all scans according to the DS-system, blinded to clinical outcomes. Results were dichotomised as 'negative' (DS: 1-3) or 'positive' (DS: 4-5). Besides percentage overall agreement we calculated agreement for positive and negative scores, expressed as positive agreement (PA) and negative agreement (NA), respectively. Results: 465 I-PET and 457 EoT-PET scans were centrally reviewed; baseline 18 F-FDG PET(/CT) was available in 75-77%, and CT in the remaining cases. Percentage overall agreement for I-PET and EoT-PET were 87.7% and 91.7% ( P =0.049), with NA of 92.0% and 95.0% ( P =0.091), and PA of 73.7% and 76.3% ( P =0.656), respectively. Conclusion: Interobserver agreement using DS in DLBCL patients in I-PET and EoT-PET yields high overall and negative agreement. The lower positive agreement suggests that EoT-PET/CT treatment evaluation in daily practice and I-PET adapted trials may benefit from dual reads and central review, respectively. Copyright © 2018 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Treatment for Insomnia in Combat-Exposed OEF/OIF/OND Military Veterans: Preliminary Randomized Controlled Trial

PubMed Central

Germain, Anne; Richardson, Robin; Stocker, Ryan; Mammen, Oommen; Hall, Martica; Bramoweth, Adam D.; Begley, Amy; Rode, Noelle; Frank, Ellen; Haas, Gretchen; Buysse, Daniel J.

2014-01-01

Objective Chronic insomnia is highly prevalent among military personnel returning from Iraq and Afghanistan. We evaluated the effects of a military version of a brief behavioral treatment of insomnia (BBTI-MV) compared to an information only control (IC) condition in combat-exposed Veterans of Operations Enduring/Iraqi Freedom or Operation New Dawn (OEF/OIF/OND) on insomnia, sleep quality, and daytime symptoms of anxiety and depression. Method Forty OEF/OIF/OND Veterans (Mean age = 38.4 years old, s.d. = 11.69; 85% men; 77.5% white) were randomized to one of two conditions. BBTI-MV consisted of two in-person sessions and two telephone contacts delivered over four weeks, and included personalized recommendations to reduce insomnia. The IC condition also consisted of 2 in-person sessions two telephone contacts delivered over four weeks, and Veterans were encouraged to read written information about sleep-promoting behaviors. The Insomnia Severity Index, Pittsburgh Sleep Quality Index, PTSD Checklist, and Beck Depression and Anxiety Inventories were completed at baseline, post-treatment, and at the six-month follow-up. Results Both interventions were associated with clinically significant improvements in insomnia, although the magnitude of improvements in sleep and rates of treatment response and remission were greater for BBTI-MV compared to IC from pre- to post-treatment. Conclusion Both BBTI-MV and the provision of information were associated with clinically significant improvements in insomnia among Veterans. Despite the preliminary nature of the findings and limitations inherent to small controlled trials, the findings suggest that both approaches may provide viable options in a stepped-care approach to the treatment of insomnia in retuning combat-exposed Veterans. Larger, confirmatory effectiveness trials are required. PMID:25194223

Review of Recent Methodological Developments in Group-Randomized Trials: Part 1—Design

PubMed Central

Li, Fan; Gallis, John A.; Prague, Melanie; Murray, David M.

2017-01-01

In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have highlighted the developments of the past 13 years in design with a companion article to focus on developments in analysis. As a pair, these articles update the 2004 review. We have discussed developments in the topics of the earlier review (e.g., clustering, matching, and individually randomized group-treatment trials) and in new topics, including constrained randomization and a range of randomized designs that are alternatives to the standard parallel-arm GRT. These include the stepped-wedge GRT, the pseudocluster randomized trial, and the network-randomized GRT, which, like the parallel-arm GRT, require clustering to be accounted for in both their design and analysis. PMID:28426295

Review of Recent Methodological Developments in Group-Randomized Trials: Part 1-Design.

PubMed

Turner, Elizabeth L; Li, Fan; Gallis, John A; Prague, Melanie; Murray, David M

2017-06-01

In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have highlighted the developments of the past 13 years in design with a companion article to focus on developments in analysis. As a pair, these articles update the 2004 review. We have discussed developments in the topics of the earlier review (e.g., clustering, matching, and individually randomized group-treatment trials) and in new topics, including constrained randomization and a range of randomized designs that are alternatives to the standard parallel-arm GRT. These include the stepped-wedge GRT, the pseudocluster randomized trial, and the network-randomized GRT, which, like the parallel-arm GRT, require clustering to be accounted for in both their design and analysis.

A Stacked Approach to Reading Intervention: Increasing 2nd- and 3rd-Graders' Independent Reading Levels with an Intervention Program

ERIC Educational Resources Information Center

Young, Chase; Durham, Patricia; Rosenbaum-Martinez, Crystal

2018-01-01

Fifty 2nd- and 3rd-grade students identified as experiencing difficulty reading were randomly assigned to experimental and control groups. In the experimental group, students received a reading intervention called Read Two Impress for a total of 360 min. Students in the control continued to receive regular instruction from their teacher. A 2 × 3…

Estimation of treatment efficacy with complier average causal effects (CACE) in a randomized stepped wedge trial.

PubMed

Gruber, Joshua S; Arnold, Benjamin F; Reygadas, Fermin; Hubbard, Alan E; Colford, John M

2014-05-01

Complier average causal effects (CACE) estimate the impact of an intervention among treatment compliers in randomized trials. Methods used to estimate CACE have been outlined for parallel-arm trials (e.g., using an instrumental variables (IV) estimator) but not for other randomized study designs. Here, we propose a method for estimating CACE in randomized stepped wedge trials, where experimental units cross over from control conditions to intervention conditions in a randomized sequence. We illustrate the approach with a cluster-randomized drinking water trial conducted in rural Mexico from 2009 to 2011. Additionally, we evaluated the plausibility of assumptions required to estimate CACE using the IV approach, which are testable in stepped wedge trials but not in parallel-arm trials. We observed small increases in the magnitude of CACE risk differences compared with intention-to-treat estimates for drinking water contamination (risk difference (RD) = -22% (95% confidence interval (CI): -33, -11) vs. RD = -19% (95% CI: -26, -12)) and diarrhea (RD = -0.8% (95% CI: -2.1, 0.4) vs. RD = -0.1% (95% CI: -1.1, 0.9)). Assumptions required for IV analysis were probably violated. Stepped wedge trials allow investigators to estimate CACE with an approach that avoids the stronger assumptions required for CACE estimation in parallel-arm trials. Inclusion of CACE estimates in stepped wedge trials with imperfect compliance could enhance reporting and interpretation of the results of such trials.

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Finding a Donor

MedlinePlus

... became mother's motivation Be The Match Blog Stories Anna, transplant recipient and her daughter Every patient — from ... your doctor Clinical Trials Read results of recent studies Find a clinical trial Before Transplant Things to ...

Patients and families

MedlinePlus

... became mother's motivation Be The Match Blog Stories Anna, transplant recipient and her daughter Every patient — from ... your doctor Clinical Trials Read results of recent studies Find a clinical trial Before Transplant Things to ...

Treatment Before Transplant

MedlinePlus

... became mother's motivation Be The Match Blog Stories Anna, transplant recipient and her daughter Every patient — from ... your doctor Clinical Trials Read results of recent studies Find a clinical trial Before Transplant Things to ...

Life After Transplant

MedlinePlus

... became mother's motivation Be The Match Blog Stories Anna, transplant recipient and her daughter Every patient — from ... your doctor Clinical Trials Read results of recent studies Find a clinical trial Before Transplant Things to ...

Using re-randomization to increase the recruitment rate in clinical trials - an assessment of three clinical areas.

PubMed

Kahan, Brennan C

2016-12-13

Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be increased in practice. We modelled the expected recruitment rate for parallel-group and re-randomization trials in different settings based on estimates from real trials and datasets. We considered three clinical areas: in vitro fertilization, severe asthma exacerbations, and acute sickle cell pain crises. We compared the two designs in terms of the expected time to complete recruitment, and the sample size recruited over a fixed recruitment period. Across the different scenarios we considered, we estimated that re-randomization could reduce the expected time to complete recruitment by between 4 and 22 months (relative reductions of 19% and 45%), or increase the sample size recruited over a fixed recruitment period by between 29% and 171%. Re-randomization can increase recruitment most for trials with a short follow-up period, a long trial recruitment duration, and patients with high rates of treatment episodes. Re-randomization has the potential to increase the recruitment rate in certain settings, and could lead to quicker and more efficient trials in these scenarios.

Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.

PubMed

Blencowe, Natalie S; Cook, Jonathan A; Pinkney, Thomas; Rogers, Chris; Reeves, Barnaby C; Blazeby, Jane M

2017-04-01

Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

Two Autistic Savant Readers.

ERIC Educational Resources Information Center

O'Connor, N.; Hermelin, B.

1994-01-01

Two young autistic children exhibited normal reading comprehension but reading speeds considerably faster than controls. The effect of randomizing word order was minimal for the older of the two autistic boys. Results indicate that efficient grapheme-phoneme conversion is primarily responsible for the fast reading of the autistic children.…

Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial.

PubMed

Tang, Paul C; Overhage, J Marc; Chan, Albert Solomon; Brown, Nancy L; Aghighi, Bahar; Entwistle, Martin P; Hui, Siu Lui; Hyde, Shauna M; Klieman, Linda H; Mitchell, Charlotte J; Perkins, Anthony J; Qureshi, Lubna S; Waltimyer, Tanya A; Winters, Leigha J; Young, Charles Y

2013-05-01

To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes. Engaging and Motivating Patients Online With Enhanced Resources for Diabetes was a 12-month parallel randomized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin (A1C) values ≥7.5% from primary care sites sharing an electronic health record. The intervention included: (1) wirelessly uploaded home glucometer readings with graphical feedback; (2) comprehensive patient-specific diabetes summary status report; (3) nutrition and exercise logs; (4) insulin record; (5) online messaging with the patient's health team; (6) nurse care manager and dietitian providing advice and medication management; and (7) personalized text and video educational 'nuggets' dispensed electronically by the care team. A1C was the primary outcome variable. Compared with usual care (UC, n=189), patients in the intervention (INT, n=193) group had significantly reduced A1C at 6 months (-1.32% INT vs -0.66% UC; p<0.001). At 12 months, the differences were not significant (-1.14% INT vs -0.95% UC; p=0.133). In post hoc analysis, significantly more INT patients had improved diabetes control (>0.5% reduction in A1C) than UC patients at 12 months (69.9 (95% CI 63.2 to 76.5) vs 55.4 (95% CI 48.4 to 62.5); p=0.006). A nurse-led, multidisciplinary health team can manage a population of diabetic patients in an online disease management program. INT patients achieved greater decreases in A1C at 6 months than UC patients, but the differences were not sustained at 12 months. More INT than UC patients achieved improvement in A1C (>0.5% decrease). Trial registered in clinical trials.gov: #NCT00542204.

Online disease management of diabetes: Engaging and Motivating Patients Online With Enhanced Resources-Diabetes (EMPOWER-D), a randomized controlled trial

PubMed Central

Tang, Paul C; Overhage, J Marc; Chan, Albert Solomon; Brown, Nancy L; Aghighi, Bahar; Entwistle, Martin P; Hui, Siu Lui; Hyde, Shauna M; Klieman, Linda H; Mitchell, Charlotte J; Perkins, Anthony J; Qureshi, Lubna S; Waltimyer, Tanya A; Winters, Leigha J; Young, Charles Y

2013-01-01

Objective To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes. Materials and methods Engaging and Motivating Patients Online With Enhanced Resources for Diabetes was a 12-month parallel randomized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin (A1C) values ≥7.5% from primary care sites sharing an electronic health record. The intervention included: (1) wirelessly uploaded home glucometer readings with graphical feedback; (2) comprehensive patient-specific diabetes summary status report; (3) nutrition and exercise logs; (4) insulin record; (5) online messaging with the patient's health team; (6) nurse care manager and dietitian providing advice and medication management; and (7) personalized text and video educational ‘nuggets’ dispensed electronically by the care team. A1C was the primary outcome variable. Results Compared with usual care (UC, n=189), patients in the intervention (INT, n=193) group had significantly reduced A1C at 6 months (−1.32% INT vs −0.66% UC; p<0.001). At 12 months, the differences were not significant (−1.14% INT vs −0.95% UC; p=0.133). In post hoc analysis, significantly more INT patients had improved diabetes control (>0.5% reduction in A1C) than UC patients at 12 months (69.9 (95% CI 63.2 to 76.5) vs 55.4 (95% CI 48.4 to 62.5); p=0.006). Conclusions A nurse-led, multidisciplinary health team can manage a population of diabetic patients in an online disease management program. INT patients achieved greater decreases in A1C at 6 months than UC patients, but the differences were not sustained at 12 months. More INT than UC patients achieved improvement in A1C (>0.5% decrease). Trial registered in clinical trials.gov: #NCT00542204 PMID:23171659

Clinical Trials Management | Division of Cancer Prevention

Cancer.gov

Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

Reading Ahead: Adult Music Students' Eye Movements in Temporally Controlled Performances of a Children's Song

ERIC Educational Resources Information Center

Penttinen, Marjaana; Huovinen, Erkki; Ylitalo, Anna-Kaisa

2015-01-01

In the present study, education majors minoring in music education (n = 24) and music performance majors (n =14) read and performed the original version and melodically altered versions of a simple melody in a given tempo. Eye movements during music reading and piano performances were recorded. Errorless trials were analyzed to explore the…

Replicability of sight word training and phonics training in poor readers: a randomised controlled trial

PubMed Central

Kohnen, S; Jones, K; Eve, P; Banales, E; Larsen, L; Castles, A

2015-01-01

Given the importance of effective treatments for children with reading impairment, paired with growing concern about the lack of scientific replication in psychological science, the aim of this study was to replicate a quasi-randomised trial of sight word and phonics training using a randomised controlled trial (RCT) design. One group of poor readers (N = 41) did 8 weeks of phonics training (i.e., phonological decoding) and then 8 weeks of sight word training (i.e., whole-word recognition). A second group did the reverse order of training. Sight word and phonics training each had a large and significant valid treatment effect on trained irregular words and word reading fluency. In addition, combined sight word and phonics training had a moderate and significant valid treatment effect on nonword reading accuracy and fluency. These findings demonstrate the reliability of both phonics and sight word training in treating poor readers in an era where the importance of scientific reliability is under close scrutiny. PMID:26019992

Cord Blood and Transplants

MedlinePlus

... became mother's motivation Be The Match Blog Stories Anna, transplant recipient and her daughter Every patient — from ... your doctor Clinical Trials Read results of recent studies Find a clinical trial Before Transplant Things to ...

Choosing a Transplant Center

MedlinePlus

... became mother's motivation Be The Match Blog Stories Anna, transplant recipient and her daughter Every patient — from ... your doctor Clinical Trials Read results of recent studies Find a clinical trial Before Transplant Things to ...

Physical Health and Recovery

MedlinePlus

... became mother's motivation Be The Match Blog Stories Anna, transplant recipient and her daughter Every patient — from ... your doctor Clinical Trials Read results of recent studies Find a clinical trial Before Transplant Things to ...

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis.

PubMed

Turner, Elizabeth L; Prague, Melanie; Gallis, John A; Li, Fan; Murray, David M

2017-07-01

In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.

Run-Reversal Equilibrium for Clinical Trial Randomization

PubMed Central

Grant, William C.

2015-01-01

In this paper, we describe a new restricted randomization method called run-reversal equilibrium (RRE), which is a Nash equilibrium of a game where (1) the clinical trial statistician chooses a sequence of medical treatments, and (2) clinical investigators make treatment predictions. RRE randomization counteracts how each investigator could observe treatment histories in order to forecast upcoming treatments. Computation of a run-reversal equilibrium reflects how the treatment history at a particular site is imperfectly correlated with the treatment imbalance for the overall trial. An attractive feature of RRE randomization is that treatment imbalance follows a random walk at each site, while treatment balance is tightly constrained and regularly restored for the overall trial. Less predictable and therefore more scientifically valid experiments can be facilitated by run-reversal equilibrium for multi-site clinical trials. PMID:26079608

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

Research Design Options for Intervention Studies.

PubMed

Lobo, Michele A; Kagan, Sarah H; Corrigan, John D

2017-07-01

To review research designs for rehabilitation. Single-case, observational, and qualitative designs are highlighted in terms of recent advances and ability to answer important scientific questions about rehabilitation. Single-case, observational, and qualitative designs can be conducted in a systematic and rigorous manner that provides important information that cannot be acquired using more common designs, such as randomized controlled trials. These less commonly used designs may be more feasible and effective in answering many research questions in the field of rehabilitation. Researchers should consider these designs when selecting the optimal design to answer their research questions. We should improve education about the advantages and disadvantages of existing research designs to enable more critical analysis of the scientific literature we read and review to avoid undervaluing studies not within more commonly used categories.

Effect of food additives on hyperphosphatemia among patients with end-stage renal disease: a randomized controlled trial.

PubMed

Sullivan, Catherine; Sayre, Srilekha S; Leon, Janeen B; Machekano, Rhoderick; Love, Thomas E; Porter, David; Marbury, Marquisha; Sehgal, Ashwini R

2009-02-11

High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well. To prevent hyperphosphatemia, patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus. However, phosphorus-containing additives are increasingly being added to processed and fast foods. The effect of such additives on serum phosphorus levels is unclear. To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease. Cluster randomized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio. Two hundred seventy-nine patients with elevated baseline serum phosphorus levels (>5.5 mg/dL) were recruited between May and October 2007. Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were randomly assigned to an intervention or control group. Intervention participants (n=145) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants. Control participants (n=134) continued to receive usual care. Change in serum phosphorus level after 3 months. At baseline, there was no significant difference in serum phosphorus levels between the 2 groups. After 3 months, the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants (95% confidence interval, -1.0 to -0.1 mg/dL). Intervention participants also had statistically significant increases in reading ingredient lists (P<.001) and nutrition facts labels (P = .04) but no significant increase in food knowledge scores (P = .13). Educating end-stage renal disease patients to avoid phosphorus-containing food additives resulted in modest improvements in hyperphosphatemia. clinicaltrials.gov Identifier: NCT00583570.

The Presence or Absence of QTc Prolongation in Buprenorphine-Naloxone Among Youth with Opioid Dependence

PubMed Central

Poole, Sabrina A.; Pecoraro, Anna; Subramaniam, Geetha; Woody, George; Vetter, Victoria L

2015-01-01

Objective To evaluate buprenorphine-naloxone effects on the QTc in youth with opioid dependence. Buprenorphine is a partial agonist that is an effective treatment for opioid dependence. Compared to methadone it has a lower risk of QTc prolongation in adults but is less well studied in youth. It may also reduce the risk for torsades de pointes (TdP) an uncommon variant of polymorphic ventricular tachycardia, that can result in syncope, ventricular fibrillation, and sudden death. Methods Secondary analysis of ECG data from 95 subjects who participated in a multi-site trial for youth with opioid dependence. Subjects were randomized to a 2-week (DETOX), or a 12-week course of buprenorphine-naloxone (BUP). 12-lead ECGs were done at baseline, weeks 4 and 12, and QTc intervals were hand measured and calculated using Bazett's formula. Increases > 60 milliseconds (ms) were considered clinically significant, and readings > 450 ms (males) and 470 ms (females) indicated a prolonged QTc. Results Mean QTc intervals were higher for BUP than DETOX participants at baseline, week 4, and week 12 (p = 0.045), and females had longer mean QTc intervals than males (p < 0.0005). Variations in QTc intervals were observed in some, however none were above 500 ms, the level at which risk for TdP becomes more significant. Conclusion In this randomized trial, the mean QTc at baseline, before randomization, was higher in BUP than DETOX patients. Minimal changes in the QTc were seen at 4 and 12-weeks in a few patients in both groups. There was no evidence that buprenorphine-naloxone alone increased the QTc to a level that increased the risk for TdP. PMID:26690291

Presence or Absence of QTc Prolongation in Buprenorphine-Naloxone Among Youth With Opioid Dependence.

PubMed

Poole, Sabrina A; Pecoraro, Anna; Subramaniam, Geetha; Woody, George; Vetter, Victoria L

2016-01-01

The aim of the study was to evaluate buprenorphine-naloxone effects on the QTc in youth with opioid dependence. Buprenorphine is a partial agonist that is an effective treatment for opioid dependence. Compared with methadone, it has a lower risk of QTc prolongation in adults, but is less studied in the youth. It may also reduce the risk of torsades de pointes (TdP)--an uncommon variant of polymorphic ventricular tachycardia--that can result in syncope, ventricular fibrillation, and sudden death. Secondary analysis of the electrocardiogram data from 95 individuals who participated in a multisite trial for youth with opioid dependence. The participants were randomized to a 2-week (DETOX) or a 12-week course of buprenorphine-naloxone (BUP). At baseline, 12-lead electrocardiograms were done at weeks 4 and 12, and QTc intervals were hand-measured and calculated using Bazett formula. Increases above 60 milliseconds were considered clinically significant, and readings above 450 milliseconds (in men) and 470 milliseconds (in women) indicated a prolonged QTc. Mean QTc intervals were higher for BUP than for DETOX participants at baseline, week 4, and week 12 (P = 0.045), and women had longer mean QTc intervals than men (P < 0.0005). Variations in the QTc intervals were observed in some; however, none were above 500 milliseconds--the level at which risk for TdP becomes more significant. In this randomized trial, the mean QTc at baseline, before randomization, was higher in BUP than in DETOX patients. Minimal changes in the QTc were seen at 4 and 12 weeks in a few patients in both groups. There was no evidence that buprenorphine-naloxone alone increased the QTc to a level that increased the risk for TdP.

Development and face validation of a Virtual Reality Epley Maneuver System (VREMS) for home Epley treatment of benign paroxysmal positional vertigo: A randomized, controlled trial.

PubMed

Tabanfar, Reza; Chan, Harley H L; Lin, Vincent; Le, Trung; Irish, Jonathan C

To develop and validate a smartphone based Virtual Reality Epley Maneuver System (VREMS) for home use. A smartphone application was designed to produce stereoscopic views of a Virtual Reality (VR) environment, which when viewed after placing a smartphone in a virtual reality headset, allowed the user to be guided step-by-step through the Epley maneuver in a VR environment. Twenty healthy participants were recruited and randomized to undergo either assisted Epleys or self-administered Epleys following reading instructions from an Instructional Handout (IH). All participants were filmed and two expert Otologists reviewed the videos, assigning each participant a score (out of 10) for performance on each step. Participants rated their perceived workload by completing a validated task-load questionnaire (NASA Task Load Index) and averages for both groups were calculated. Twenty participants were evaluated with average age 26.4±7.12years old in the VREMS group and 26.1±7.72 in the IH group. The VR assisted group achieved an average score of 7.78±0.99 compared to 6.65±1.72 in the IH group. This result was statistically significant with p=0.0001 and side dominance did not appear to play a factor. Analyzing each step of the Epley maneuver demonstrated that assisted Epleys were done more accurately with statically significant results in steps 2-4. Results of the NASA-TLX scores were variable with no significant findings. We have developed and demonstrated face validity for VREMS through our randomized controlled trial. The VREMS platform is promising technology, which may improve the accuracy and effectiveness of home Epley treatments. N/A. Copyright © 2017 Elsevier Inc. All rights reserved.

Texting atopic dermatitis patients to optimize learning and eczema area and severity index scores: A pilot randomized control trial.

PubMed

Singer, Hannah M; Levin, Laura E; Morel, Kimberly D; Garzon, Maria C; Stockwell, Melissa S; Lauren, Christine T

2018-05-02

Atopic dermatitis is a common, chronic, debilitating disease. Poor adherence to treatment is the most important preventable contributor to adverse outcomes. Thus, improving adherence can improve patient outcomes. Text message reminders with embedded condition-specific information have been shown to improve pediatric immunization adherence but have not been assessed in atopic dermatitis. The objective was to assess the effect of daily text messages on Eczema Area Severity Index scores and caregiver knowledge of atopic dermatitis. In this pilot randomized controlled trial, caregivers of children with atopic dermatitis enrolled during their initial appointment with a pediatric dermatologist and randomized 1:1 to standard care or daily text messages with patient education material and treatment reminders. Participants completed a multiple-choice atopic dermatitis knowledge quiz at initial and follow-up visits, and Eczema Area Severity Index scores were assessed. Forty-two patients enrolled, and 30 completed the study: 16 standard care group, 14 text message group. There was no significant difference in Eczema Area Severity Index score between the standard care and text message groups at follow-up, with mean decreases in Eczema Area Severity Index score of 53% and 58%, respectively. Mean score on follow-up atopic dermatitis knowledge quiz was significantly higher in the text message group (84% correct) than in the standard care group (75% correct) (P = .04). This pilot study did not demonstrate a difference in Eczema Area Severity Index scores with text message reminders. The significantly higher follow-up atopic dermatitis quiz score in the text message group indicates that participants read and retained information from text messages. Limitations include small sample size and short duration of follow-up. © 2018 Wiley Periodicals, Inc.

An online spaced-education game among clinicians improves their patients' time to blood pressure control: a randomized controlled trial.

PubMed

Kerfoot, B Price; Turchin, Alexander; Breydo, Eugene; Gagnon, David; Conlin, Paul R

2014-05-01

Many patients with high blood pressure (BP) do not have antihypertensive medications appropriately intensified at clinician visits. We investigated whether an online spaced-education (SE) game among primary care clinicians can decrease time to BP target among their hypertensive patients. A 2-arm randomized trial was conducted over 52 weeks among primary care clinicians at 8 hospitals. Educational content consisted of 32 validated multiple-choice questions with explanations on hypertension management. Providers were randomized into 2 groups: SE clinicians were enrolled in the game, whereas control clinicians received identical educational content in an online posting. SE game clinicians were e-mailed 1 question every 3 days. Adaptive game mechanics resent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition. Primary outcome measure was time to BP target (<140/90 mm Hg). One hundred eleven clinicians enrolled. The SE game was completed by 87% of clinicians (48/55), whereas 84% of control clinicians (47/56) read the online posting. In multivariable analysis of 17 866 hypertensive periods among 14 336 patients, the hazard ratio for time to BP target in the SE game cohort was 1.043 (95% confidence interval, 1.007-1.081; P=0.018). The number of hypertensive episodes needed to treat to normalize one additional patient's BP was 67.8. The number of clinicians needed to teach to achieve this was 0.43. An online SE game among clinicians generated a modest but significant reduction in the time to BP target among their hypertensive patients. http://www.clinicaltrials.gov. Unique identifier: NCT00904007. © 2014 American Heart Association, Inc.

A Randomized Controlled Trial to Evaluate an Internet-Based Self-Management Program in Systemic Sclerosis.

PubMed

Khanna, Dinesh; Serrano, Jennifer; Berrocal, Veronica J; Silver, Richard M; Cuencas, Pedro; Newbill, Sharon L; Battyany, Josephine; Maxwell, Cynthia; Alore, Mary; Dyas, Laura; Riggs, Robert; Connolly, Kerri; Kellner, Saville; Fisher, Jody J; Bush, Erica; Sachdeva, Anjali; Evnin, Luke; Raisch, Dennis W; Poole, Janet L

2018-05-09

A pilot study showed that an internet-based self-management program improves self-efficacy in systemic sclerosis (SSc). The objective of the present study was to compare the internet-based self-management program to an educational book developed for people with SSc in measures of self-efficacy and other patient-reported outcomes. A 16-week randomized, controlled trial. Of the 267 participants who completed baseline questionnaires and were randomized to the intervention (internet) or control (book) condition, 123 (93%) in the internet and 124 (94%) in the control completed the 16-week RCT. The mean (SD) age of all participants was 53.7 (11.7) years, 91% were female, and 79.4% had some college or a higher degree. The mean (SD) disease duration after diagnosis of SSc was 8.97 (8.50) years. There were no statistical differences between the 2 groups for the primary outcome measure (PROMIS Self Efficacy Managing Symptoms: mean change of 0.35 in the internet group vs. 0.94 in control group, p=0.47) and secondary outcome measures, except the EQ5D visual analog scale (p=0.05). Internet group participants agreed that the self-management modules were of importance to them, the information was presented clearly, and the website was easy to use and at an appropriate reading level. Our RCT showed that the internet-based self-management website was not statistically superior to an educational patient-focused book in improving self-efficacy and other measures. The participants were enthusiastic for the content and presentation of the self-management website. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial.

PubMed

Esplen, Mary Jane; Wong, Jiahui; Warner, Ellen; Toner, Brenda

2018-03-10

Purpose This study aimed to test a group psychosocial intervention focused on improving disturbances of body image (BI), sexual functioning, and quality of life in breast cancer (BC) survivors. Methods A prospective, randomized controlled trial was conducted to assess the efficacy of an 8-week group intervention in women after BC treatment. The manual-based intervention combined two powerful ingredients: expressive guided-imagery exercises integrated within a model of group-therapy principles. The intervention facilitates exploration of identity, the development of new self-schemas, and personal growth. In addition, the intervention included an educational component on the social and cultural factors affecting women's self-esteem and BI. The control condition included standard care plus educational reading materials. One hundred ninety-four BC survivors who had expressed concerns about negative BI and/or difficulties with sexual functioning participated in the study; 131 were randomly assigned to the intervention, and 63 were assigned to the control condition. Participants were followed for 1 year. Results Women in the intervention group reported significantly less concern/distress about body appearance ( P < .01), decreased body stigma ( P < .01), and lower level of BC-related concerns ( P < .01), compared with women in the control group. BC-related quality of life was also better in the intervention group compared with the control group at the 1-year follow-up ( P < .01). There was no statistically significant group difference in sexual functioning. Conclusion Restoring Body Image After Cancer (ReBIC), a group intervention using guided imagery within a group-therapy approach, is an effective method for addressing BI-related concerns and quality of life post-BC. The manual-based intervention can be easily adapted to both cancer centers and primary care settings.

Fitness, fatness, cognition, behavior, and academic achievement among overweight children: Do cross-sectional associations correspond to exercise trial outcomes?

PubMed Central

Davis, Catherine L.; Cooper, Stephanie

2011-01-01

Background This study examined associations of fitness and fatness with cognitive processes, academic achievement, and behavior, independent of demographic factors, at the baseline of an exercise trial. Methods Overweight, sedentary but otherwise healthy 7–11 year olds (N=170) participated in a study of health, cognition and achievement in the Augusta, GA area from 2003–2006. Children underwent evaluations of fatness and fitness, psychological assessments of cognition and academic achievement, and behavior ratings by parents and teachers. Partial correlations examined associations of fitness and fatness with cognitive and achievement scores and behavior ratings, controlling for demographic factors. Results Fitness was associated with better cognition, achievement and behavior, and fatness with worse scores. Specifically, executive function, mathematics and reading achievement, and parent ratings of child behavior were related to fitness and fatness. Teacher ratings were related to fitness. Conclusion These results extend prior studies by providing reliable, standardized measures of cognitive processes, achievement, and behavior in relation to detailed measures of fitness and fatness. However, cross-sectional associations do not necessarily indicate that improving one factor, such as fatness or fitness, will result in improvements in factors that were associated with it. Thus, randomized clinical trials are necessary to determine the effects of interventions. PMID:21281668

Fitness, fatness, cognition, behavior, and academic achievement among overweight children: do cross-sectional associations correspond to exercise trial outcomes?

PubMed

Davis, Catherine L; Cooper, Stephanie

2011-06-01

This study examined associations of fitness and fatness with cognitive processes, academic achievement, and behavior, independent of demographic factors, at the baseline of an exercise trial. Overweight, sedentary but otherwise healthy 7-11 year olds (N=170) participated in a study of health, cognition and achievement in the Augusta, GA area from 2003-2006. Children underwent evaluations of fatness and fitness, psychological assessments of cognition and academic achievement, and behavior ratings by parents and teachers. Partial correlations examined associations of fitness and fatness with cognitive and achievement scores and behavior ratings, controlling for demographic factors. Fitness was associated with better cognition, achievement and behavior, and fatness with worse scores. Specifically, executive function, mathematics and reading achievement, and parent ratings of child behavior were related to fitness and fatness. Teacher ratings were related to fitness. These results extend prior studies by providing reliable, standardized measures of cognitive processes, achievement, and behavior in relation to detailed measures of fitness and fatness. However, cross-sectional associations do not necessarily indicate that improving one factor, such as fatness or fitness, will result in improvements in factors that were associated with it. Thus, randomized clinical trials are necessary to determine the effects of interventions. Copyright © 2011. Published by Elsevier Inc.

Do Specific Relevance Instructions Promote Transfer Appropriate Processing?

ERIC Educational Resources Information Center

McCrudden, Matthew T.

2011-01-01

This study examined whether specific relevance instructions affect transfer appropriate processing. Undergraduates (n = 52) were randomly assigned to one of three pre-reading question conditions that asked them what-questions, why-questions, or to read for understanding (i.e., control condition). There were no differences in reading time across…

Building Vocabulary Knowledge in Preschoolers through Shared Book Reading and Gameplay

ERIC Educational Resources Information Center

Hassinger-Das, Brenna; Ridge, Katherine; Parker, Amira; Golinkoff, Roberta Michnick; Hirsh-Pasek, Kathy; Dickinson, David K.

2016-01-01

This study moves beyond previous investigations to examine whether an educational intervention combining shared book reading with a vocabulary game increases children's vocabulary knowledge. Four-year-olds (N = 44) were randomly assigned to dyads in either an intervention (shared book reading plus vocabulary review game) or comparison condition…

Collaborative Strategic Reading for Students with Learning Disabilities in Upper Elementary Classrooms

ERIC Educational Resources Information Center

Boardman, Alison G.; Vaughn, Sharon; Buckley, Pamela; Reutebuch, Colleen; Roberts, Greg; Klingner, Janette

2016-01-01

Sixty fourth- and fifth-grade general education teachers were randomly assigned to teach Collaborative Strategic Reading (CSR; Klingner, Vaughn, Boardman, & Swanson, 2012), a set of reading comprehension strategies, or to a business-as-usual comparison group. Results demonstrate that students with learning disabilities (LD) who received CSR…

Professional Literature: Who Reads It?

ERIC Educational Resources Information Center

Lewis, Patricia F.

1977-01-01

To find out if professional periodicals and books are really being read, the American Management Association and the American Society for Training and Development made a joint national survey of the reading habits of three thousand training managers randomly selected from their memberships. Charts of the 801 responses are presented and discussed.…

Validation of a Supplemental Reading Intervention for First-Grade Children

ERIC Educational Resources Information Center

Case, Lisa Pericola; Speece, Deborah L.; Silverman, Rebecca; Ritchey, Kristen D.; Schatschneider, Christopher; Cooper, David H.; Montanaro, Elizabeth; Jacobs, Dawn

2010-01-01

This experimental study was designed to validate a short-term supplemental reading intervention for at-risk first-grade children. Although substantial research on long-term supplemental reading interventions exists, less is known about short-term interventions. Thirty first-grade children were randomly assigned to intervention or control…

A Report on IRI Scoring and Interpretation.

ERIC Educational Resources Information Center

Anderson, Betty

Noting that most classroom teachers use informal reading inventories (IRI) as diagnostic instruments, a study examined what oral reading accuracy level is most appropriate for the instructional level and whether repetitions should be counted as oral reading errors. Randomly selected students from the second through fifth grades at two elementary…

Adult Age Differences in Knowledge-Driven Reading

ERIC Educational Resources Information Center

Miller, Lisa M. Soederberg; Stine-Morrow, Elizabeth A. L.; Kirkorian, Heather L.; Conroy, Michelle L.

2004-01-01

The authors investigated the effects of domain knowledge on online reading among younger and older adults. Individuals were randomly assigned to either a domain-relevant (i.e., high-knowledge) or domain-irrelevant (i.e., low-knowledge) training condition. Two days later, participants read target passages on a computer that drew on information…

Reading Attitudes of Texas High School Students

ERIC Educational Resources Information Center

Bussert-Webb, Kathy; Zhang, Zhidong

2016-01-01

Through random sampling, we surveyed 2,568 high school students throughout Texas to determine their reading attitudes vis-à-vis individual and school background variables. Sources were the Rhody reading attitude scale and public domain campus summary data; the lenses of attitude theory and social justice informed this study. Significant…

What can Written-Words Tell us About Lexical Retrieval in Speech Production?

PubMed Central

Navarrete, Eduardo; Mahon, Bradford Z.; Lorenzoni, Anna; Peressotti, Francesca

2016-01-01

In recent decades, researchers have exploited semantic context effects in picture naming tasks in order to investigate the mechanisms involved in the retrieval of words from the mental lexicon. In the blocked naming paradigm, participants name target pictures that are either blocked or not blocked by semantic category. In the continuous naming task, participants name a sequence of target pictures that are drawn from multiple semantic categories. Semantic context effects in both tasks are a highly reliable phenomenon. The empirical evidence is, however, sparse and inconsistent when the target stimuli are printed-words instead of pictures. In the first part of the present study we review the empirical evidence regarding semantic context effects with written-word stimuli in the blocked and continuous naming tasks. In the second part, we empirically test whether semantic context effects are transferred from picture naming trials to word reading trials, and from word reading trials to picture naming trials. The results indicate a transfer of semantic context effects from picture naming to subsequently read within-category words. There is no transfer of semantic effects from target words that were read to subsequently named within-category pictures. These results replicate previous findings (Navarrete et al., 2010) and are contrary to predictions from a recent theoretical analysis by Belke (2013). The empirical evidence reported in the literature together with the present results, are discussed in relation to current accounts of semantic context effects in speech production. PMID:26779090

Clinical predictors of the optimal spectacle correction for comfort performing desktop tasks.

PubMed

Leffler, Christopher T; Davenport, Byrd; Rentz, Jodi; Miller, Amy; Benson, William

2008-11-01

The best strategy for spectacle correction of presbyopia for near tasks has not been determined. Thirty volunteers over the age of 40 years were tested for subjective accommodative amplitude, pupillary size, fusional vergence, interpupillary distance, arm length, preferred working distance, near and far visual acuity and preferred reading correction in the phoropter and trial frames. Subjects performed near tasks (reading, writing and counting change) using various spectacle correction strengths. Predictors of the correction maximising near task comfort were determined by multivariable linear regression. The mean age was 54.9 years (range 43 to 71) and 40 per cent had diabetes. Significant predictors of the most comfortable addition in univariate analyses were age (p<0.001), interpupillary distance (p=0.02), fusional vergence amplitude (p=0.02), distance visual acuity in the worse eye (p=0.01), vision at 40 cm in the worse eye with distance correction (p=0.01), duration of diabetes (p=0.01), and the preferred correction to read at 40 cm with the phoropter (p=0.002) or trial frames (p<0.001). Target distance selected wearing trial frames (in dioptres), arm length, and accommodative amplitude were not significant predictors (p>0.15). The preferred addition wearing trial frames holding a reading target at a distance selected by the patient was the only independent predictor. Excluding this variable, distance visual acuity was predictive independent of age or near vision wearing distance correction. The distance selected for task performance was predicted by vision wearing distance correction at near and at distance. Multivariable linear regression can be used to generate tables based on distance visual acuity and age or near vision wearing distance correction to determine tentative near spectacle addition. Final spectacle correction for desktop tasks can be estimated by subjective refraction with trial frames.

Effect of Modified Otago Exercises on Postural Balance, Fear of Falling, and Fall Risk in Older Fallers With Knee Osteoarthritis and Impaired Gait and Balance: A Secondary Analysis.

PubMed

Mat, Sumaiyah; Ng, Chin Teck; Tan, Pey June; Ramli, Norlisah; Fadzli, Farhana; Rozalli, Faizatul Izza; Mazlan, Mazlina; Hill, Keith D; Tan, Maw Pin

2018-03-01

Osteoarthritis (OA) is considered an established risk factor for falls. Published studies evaluating secondary falls prevention strategies among individuals with OA are limited. To evaluate the effect of a personalized home-based exercise program to improve postural balance, fear of falling, and falls risk in older fallers with knee OA and gait and balance problems. Randomized controlled trial. University of Malaya Medical Centre. Fallers who had both radiological OA and a Timed Up and Go (TUG) score of over 13.5 seconds. Postural sway (composite sway) was quantified with the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) under 4 different sensory conditions: eyes open on firm surface, eyes closed on firm surface, eyes open on unstable foam surface, and eyes closed on unstable foam surface. Participants were asked to stand upright and to attempt to hold their position for 10 seconds for each test condition. The average reading for all conditions were calculated. Participants randomized to the intervention arm received a home-based modified Otago Exercise Program (OEP) as part of a multifactorial intervention, whereas control participants received general health advice and conventional treatment. This was a secondary subgroup analysis from an original randomized controlled trial, the Malaysian Falls Assessment and Intervention Trial (MyFAIT) (trial registration number: ISRCTN11674947). Posturography using a long force plate balance platform (Balancemaster, NeuroCom, USA), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the short-form Falls Efficacy Scale-International (short FES-I) were assessed at baseline and 6 months. Results of 41 fallers with radiological evidence of OA and impaired TUG (intervention, 17; control, 24) were available for the final analysis. Between-group analysis revealed significant improvements in the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), Limits of Stability (LOS), and short FES-I scores by the intervention group compared to the control group at 6 months. No significant difference in time to first fall or in fall-free survival between the intervention and control groups was found. Home-based balance and strength exercises benefited older fallers with OA and gait and balance disorders by improving postural control, with no observable trend in reduction of fall recurrence. Our findings will now inform a future, adequately powered, randomized controlled study using fall events as definitive outcomes. I. Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

The Effects of Reading from the Screen on the Reading Motivation Levels of Elementary 5th Graders

ERIC Educational Resources Information Center

Aydemir, Zeynep; Ozturk, Ergun

2012-01-01

This study aims to explore the effects of reading from the screen on elementary 5th grade students' reading motivation levels. It used the randomized control-group pretest-posttest model, which is a true experimental design. The study group consisted of 60 students, 30 experimental and 30 control, who were attending the 5th grade of a public…

A Comparison of Performance on Cloze Tests, Group Reading Inventories and Standardized Reading Achievement in Grades Seven, Eight and Nine.

ERIC Educational Resources Information Center

Rakes, Thomas A.; McWilliams, Lana J.

A random sample of 300 seventh, eighth, and ninth grade students participated in a comparative study of performance on social studies cloze tests, social studies group reading inventories (GRI), and a popular standardized test (Gates-MacGinitie Reading Tests, Survey E). It was found that cloze tests and GRIs constructed from social studies content…

The Effect of Speed Reading Strategies on Developing Reading Comprehension among the 2nd Secondary Students in English Language

ERIC Educational Resources Information Center

Abdelrahman, Mahmoud Sulaiman Hamad Bani; Bsharah, Muwafaq Saleem

2014-01-01

This study aimed to find the effect of speed reading strategies on developing reading comprehension among second secondary literary stream students in English language. The sample of the study consists of (42) students assigned into two groups who were chosen randomly from schools, a controlled group (21) students, and an experimental (21)…

The Connection between Print Awareness and Concepts of Reading in Young Children.

ERIC Educational Resources Information Center

Tevis, Glenna

A study investigated the relationship between reading to a child, the child's awareness of print, and the child's concept of reading. Twenty-four kindergarten children and 24 three-year-old children at a day care center were randomly assigned to three groups. Three times a week for four weeks, each child in each group was read a book in a…

Differences in the effects of school meals on children's cognitive performance according to gender, household education and baseline reading skills.

PubMed

Sørensen, L B; Damsgaard, C T; Petersen, R A; Dalskov, S-M; Hjorth, M F; Dyssegaard, C B; Egelund, N; Tetens, I; Astrup, A; Lauritzen, L; Michaelsen, K F

2016-10-01

We previously found that the OPUS School Meal Study improved reading and increased errors related to inattention and impulsivity. This study explored whether the cognitive effects differed according to gender, household education and reading proficiency at baseline. This is a cluster-randomised cross-over trial comparing Nordic school meals with packed lunch from home (control) for 3 months each among 834 children aged 8 to 11 years. At baseline and at the end of each dietary period, we assessed children's performance in reading, mathematics and the d2-test of attention. Interactions were evaluated using mixed models. Analyses included 739 children. At baseline, boys and children from households without academic education were poorer readers and had a higher d2-error%. Effects on dietary intake were similar in subgroups. However, the effect of the intervention on test outcomes was stronger in boys, in children from households with academic education and in children with normal/good baseline reading proficiency. Overall, this resulted in increased socioeconomic inequality in reading performance and reduced inequality in impulsivity. Contrary to this, the gender difference decreased in reading and increased in impulsivity. Finally, the gap between poor and normal/good readers was increased in reading and decreased for d2-error%. The effects of healthy school meals on reading, impulsivity and inattention were modified by gender, household education and baseline reading proficiency. The differential effects might be related to environmental aspects of the intervention and deserves to be investigated further in future school meal trials.

Reporting of participant flow diagrams in published reports of randomized trials

PubMed Central

2011-01-01

Background Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. Methods A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Results Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Conclusions Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented. PMID:22141446

Bayesian network meta-analysis for cluster randomized trials with binary outcomes.

PubMed

Uhlmann, Lorenz; Jensen, Katrin; Kieser, Meinhard

2017-06-01

Network meta-analysis is becoming a common approach to combine direct and indirect comparisons of several treatment arms. In recent research, there have been various developments and extensions of the standard methodology. Simultaneously, cluster randomized trials are experiencing an increased popularity, especially in the field of health services research, where, for example, medical practices are the units of randomization but the outcome is measured at the patient level. Combination of the results of cluster randomized trials is challenging. In this tutorial, we examine and compare different approaches for the incorporation of cluster randomized trials in a (network) meta-analysis. Furthermore, we provide practical insight on the implementation of the models. In simulation studies, it is shown that some of the examined approaches lead to unsatisfying results. However, there are alternatives which are suitable to combine cluster randomized trials in a network meta-analysis as they are unbiased and reach accurate coverage rates. In conclusion, the methodology can be extended in such a way that an adequate inclusion of the results obtained in cluster randomized trials becomes feasible. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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

PubMed

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

2009-01-01

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

Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial.

PubMed

Demaerschalk, Bart M; Brown, Robert D; Roubin, Gary S; Howard, Virginia J; Cesko, Eldina; Barrett, Kevin M; Longbottom, Mary E; Voeks, Jenifer H; Chaturvedi, Seemant; Brott, Thomas G; Lal, Brajesh K; Meschia, James F; Howard, George

2017-09-01

Multicenter clinical trials attempt to select sites that can move rapidly to randomization and enroll sufficient numbers of patients. However, there are few assessments of the success of site selection. In the CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials), we assess factors associated with the time between site selection and authorization to randomize, the time between authorization to randomize and the first randomization, and the average number of randomizations per site per month. Potential factors included characteristics of the site, specialty of the principal investigator, and site type. For 147 sites, the median time between site selection to authorization to randomize was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified. The median time between authorization to randomize and a randomization was 4.6 months (interquartile range, 2.6, 10.5). Sites with authorization to randomize in only the carotid endarterectomy study were slower to randomize, and other factors examined were not significantly associated with time-to-randomization. The recruitment rate was 0.26 (95% confidence interval, 0.23-0.28) patients per site per month. By univariate analysis, factors associated with faster recruitment were authorization to randomize in both trials, principal investigator specialties of interventional radiology and cardiology, pre-trial reported performance >50 carotid angioplasty and stenting procedures per year, status in the top half of recruitment in the CREST trial, and classification as a private health facility. Participation in StrokeNet was associated with slower recruitment as compared with the non-StrokeNet sites. Overall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217. © 2017 American Heart Association, Inc.

A Randomized Controlled Trial Comparing the Letter Project Advance Directive to Traditional Advance Directive.

PubMed

Periyakoil, Vyjeyanthi S; Neri, Eric; Kraemer, Helena

2017-09-01

Simpler alternatives to traditional advance directives that are easy to understand and available in multiple formats and can be initiated by patients and families will help facilitate advance care planning. The goal of this study was to compare the acceptability of the letter advance directive (LAD) to the traditional advance directive (TAD) of the state of California. A web-based, randomized controlled trial was conducted, in which the participants were randomized to one of two types of advance directives (ADs): the LAD (intervention) or the TAD (control). Primary outcomes were participant ratings of the ease, value, and their level of comfort in the AD document they completed. A total of 400 participants completed the study, with 216 randomized to the LAD and 184 to the TAD by a computerized algorithm. Overall, participants preferred the LAD to the TAD (success rate difference [SRD] = 0.46, 95th percentile confidence interval [CI]: 0.36-0.56, p < 0.001). The participants felt that, compared to the TAD, the LAD was easier to read and understand (SRD = 0.56, CI: 0.47-0.65, p < 0.001); better reflected what matters most to them (SRD = 0.39, CI: 0.29-0.48, p < 0.001); helped stimulate their thinking about the types of treatments they wanted at the end of life (SRD = 0.32, CI: 0.23-0.42, p < 0.001); allowed them to describe how they made medical decisions in their family (SRD = 0.31, CI: 0.21-0.40, p < 0.001); and could help their doctor(s) (SRD = 0.24, CI: 0.13-0.34, p < 0.001) and their families (SRD = 0.19, CI: 0.08-0.28, p < 0.001) understand their end-of-life treatment preferences. Patients reported the letter advance directive to be a better alternative to the traditional advance directive form.

[Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

PubMed

Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

2016-11-01

To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles such as blindness, randomization and control in RCTs, while requiring reporting in accordance with international standards. Copyright© by the Chinese Pharmaceutical Association.

Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

ERIC Educational Resources Information Center

Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

2017-01-01

Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

A Randomized Trial of Telephone Psychotherapy and Pharmacotherapy for Depression: Continuation and Durability of Effects

ERIC Educational Resources Information Center

Ludman, Evette J.; Simon, Gregory E.; Tutty, Steve; Von Korff, Michael

2007-01-01

Randomized trial evidence and expert guidelines are mixed regarding the value of combined pharmacotherapy and psychotherapy as initial treatment for depression. This study describes long-term results of a randomized trial (N = 393) evaluating telephone-based cognitive-behavioral therapy (CBT) plus care management for primary care patients…

Breast Cancer Screening by Physical Examination: Randomized Trial in the Phillipines

DTIC Science & Technology

2005-10-01

J -4327 TITLE: Breast Cancer Screening by Physical Examination: Randomized Trial in the Phillipines...Examination: Randomized Trial in the 5a. CONTRACT NUMBER Phillipines 5b. GRANT NUMBER DAMD17-94- J -4327 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S...Grant DAMD17-94- J -4327 3 Table of

Weighted re-randomization tests for minimization with unbalanced allocation.

PubMed

Han, Baoguang; Yu, Menggang; McEntegart, Damian

2013-01-01

Re-randomization test has been considered as a robust alternative to the traditional population model-based methods for analyzing randomized clinical trials. This is especially so when the clinical trials are randomized according to minimization, which is a popular covariate-adaptive randomization method for ensuring balance among prognostic factors. Among various re-randomization tests, fixed-entry-order re-randomization is advocated as an effective strategy when a temporal trend is suspected. Yet when the minimization is applied to trials with unequal allocation, fixed-entry-order re-randomization test is biased and thus compromised in power. We find that the bias is due to non-uniform re-allocation probabilities incurred by the re-randomization in this case. We therefore propose a weighted fixed-entry-order re-randomization test to overcome the bias. The performance of the new test was investigated in simulation studies that mimic the settings of a real clinical trial. The weighted re-randomization test was found to work well in the scenarios investigated including the presence of a strong temporal trend. Copyright © 2013 John Wiley & Sons, Ltd.

Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial.

PubMed

Ali, Hasmot; Hamadani, Jena; Mehra, Sucheta; Tofail, Fahmida; Hasan, Md Imrul; Shaikh, Saijuddin; Shamim, Abu Ahmed; Wu, Lee S-F; West, Keith P; Christian, Parul

2017-07-01

Background: The impact of early vitamin A supplementation on neurodevelopmental function has not been adequately studied. In rural Bangladesh we examined cognitive and motor function and scholastic achievement in a cohort of children who were exposed to vitamin A in utero or at birth. Objective: The aim of this study was to examine independent and combined effects of antenatal and newborn supplementation with vitamin A on the cognitive function of children at 8 y of age. Design: A cohort of rural Bangladeshi children from 2 previous double-blind, placebo-controlled cluster-randomized trials were revisited at age 8 y between February 2013 and June 2014. Data on sociodemographic, social, and physical conditions; schooling; child care behavior; anthropometric measures; and cognitive function were collected with the use of various psychometric assessment tools. Results: Among 11,950 children from the parent trial who were last known to be alive, a subset of 1803 children balanced by treatment group in a selected contiguous study area were re-enrolled and 1613 (89%) provided consent for assessments. Of these, 1577 (87%) children had a complete cognitive evaluation. All groups were highly comparable on baseline variables collected in the previous trials and factors measured at re-enrollment. Overall, there was no impact of either maternal or newborn supplementation with vitamin A on intelligence, memory, and motor function. Compared with placebo, children who received both interventions had significantly better performance in reading, spelling, and math computation, with increased mean (95% CI) scores of 8.0 (2.2, 13.8), 6.8 (1.9, 11.7), and 4.8 (0.6, 9.0), respectively. Conclusions: General intelligence or memory and motor functions were not affected by antenatal or newborn supplementation with vitamin A. Scholastic performance and aspects of executive function improved when both interventions were provided. These trials were registered at clinicaltrials.gov as NCT00198822 and NCT00128557. © 2017 American Society for Nutrition.

The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)

PubMed Central

2013-01-01

Background Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is relatively common in children with limited evidence for treatment. The Phil Parker Lightning Process (LP) is a trademarked intervention, which >250 children use annually. There are no reported studies investigating the effectiveness or possible side effects of LP. Methods The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service. The study was designed as a pilot randomized trial with children (aged 12 to 18 years) comparing specialist medical care with specialist medical care plus the Lightning Process. Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment, randomization and interventions. Results A total of 56 children were recruited from 156 eligible children (1 October 2010 to 16 June 2012). Recruitment, randomization and both interventions were feasible and acceptable. Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol: stopped collecting 6-week outcomes; introduced a second reminder letter; used phone calls to collect primary outcomes from nonresponders; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability (SF-36 physical function subscale) and fatigue (Chalder Fatigue Scale). Conclusions Conducting randomized controlled trials (RCTs) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME. Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants. This is likely to improve recruitment rate and trial retention. Trial registration Feasibility study first randomization: 29 September 2010. Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012). Full trial first randomization: 19 September 2012. PMID:24304689

The effect of computer-assisted therapeutic practice for children with handwriting deficit: a comparison with the effect of the traditional sensorimotor approach.

PubMed

Chang, Shao-Hsia; Yu, Nan-Ying

2014-07-01

The objective of this study was to compare the effect of computer-assisted practice with the sensorimotor approach on the remediation of handwriting problems in children with dysgraphia. In a randomized controlled trial, experiments were conducted to verify the intervention effect. Forty two children with handwriting deficit were assigned to computer-assisted instruction, sensorimotor training, or a control group. Handwriting performance was measured using the elementary reading/writing test and computerized handwriting evaluation before and after 6 weeks of intervention. Repeated-measures ANOVA of changed scores were conducted to show whether statistically significant differences across the three groups were present. Significant differences in the elementary reading/writing test were found among the three groups. The computer group showed more significant improvements than the other two groups did. In the kinematic and kinetic analyses, the computer group showed promising results in the remediation of handwriting speed and fluency. This study provided clinical evidence for applying a computer-assisted handwriting program for children with dysgraphia. Clinicians and school teachers are provided with a systematic intervention for the improvement of handwriting difficulties. Copyright © 2014 Elsevier Ltd. All rights reserved.

Report on Phase I (Interest, Comprehension, & Readability) Prepublication Learner Verification of "Reading Basics Plus," Harper & Row, Publishers, Inc.

ERIC Educational Resources Information Center

Ball, Edward H.

"Reading Basics Plus" consists of an integrated set of texts, workbooks, duplicating masters, word cards, charts, and teacher's guidebooks. By a process of small group trials, students' and teachers' reactions to the proposed content of the "Reading Basics Plus" program for grades four, five, and six were obtained in order to provide editors and…

Read clouds uncover variation in complex regions of the human genome.

PubMed

Bishara, Alex; Liu, Yuling; Weng, Ziming; Kashef-Haghighi, Dorna; Newburger, Daniel E; West, Robert; Sidow, Arend; Batzoglou, Serafim

2015-10-01

Although an increasing amount of human genetic variation is being identified and recorded, determining variants within repeated sequences of the human genome remains a challenge. Most population and genome-wide association studies have therefore been unable to consider variation in these regions. Core to the problem is the lack of a sequencing technology that produces reads with sufficient length and accuracy to enable unique mapping. Here, we present a novel methodology of using read clouds, obtained by accurate short-read sequencing of DNA derived from long fragment libraries, to confidently align short reads within repeat regions and enable accurate variant discovery. Our novel algorithm, Random Field Aligner (RFA), captures the relationships among the short reads governed by the long read process via a Markov Random Field. We utilized a modified version of the Illumina TruSeq synthetic long-read protocol, which yielded shallow-sequenced read clouds. We test RFA through extensive simulations and apply it to discover variants on the NA12878 human sample, for which shallow TruSeq read cloud sequencing data are available, and on an invasive breast carcinoma genome that we sequenced using the same method. We demonstrate that RFA facilitates accurate recovery of variation in 155 Mb of the human genome, including 94% of 67 Mb of segmental duplication sequence and 96% of 11 Mb of transcribed sequence, that are currently hidden from short-read technologies. © 2015 Bishara et al.; Published by Cold Spring Harbor Laboratory Press.

A Data Management System Integrating Web-based Training and Randomized Trials: Requirements, Experiences and Recommendations.

PubMed

Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D

2011-01-01

This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance of web-course-trained participants (intervention group) and printed-manual-trained participants (comparison group) to determine the effectiveness of the web-course in teaching CBT skills. A single DMS was needed to support all aspects of the study: web-course delivery and management, as well as randomized trial management. The authors briefly reviewed several other systems that were described as built either to handle randomized trials or to deliver and evaluate web-based training. However it was clear that these systems fell short of meeting our needs for simultaneous, coordinated management of the web-course and the randomized trial. New England Research Institute's (NERI) proprietary Advanced Data Entry and Protocol Tracking (ADEPT) system was coupled with the web-programmed course and customized for our purposes. This article highlights the requirements for a DMS that operates at the intersection of web-based course management systems and randomized clinical trial systems, and the extent to which the coupled, customized ADEPT satisfied those requirements. Recommendations are included for institutions and individuals considering conducting randomized trials and web-based training programs, and seeking a DMS that can meet similar requirements.

Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement.

PubMed

Zhang, J; Chen, X; Zhu, Q; Cui, J; Cao, L; Su, J

2016-11-01

In recent years, the number of randomized controlled trials (RCTs) in the field of orthopaedics is increasing in Mainland China. However, randomized controlled trials (RCTs) are inclined to bias if they lack methodological quality. Therefore, we performed a survey of RCT to assess: (1) What about the quality of RCTs in the field of orthopedics in Mainland China? (2) Whether there is difference between the core journals of the Chinese department of orthopedics and Orthopaedics Traumatology Surgery & Research (OTSR). This research aimed to evaluate the methodological reporting quality according to the CONSORT statement of randomized controlled trials (RCTs) in seven key orthopaedic journals published in Mainland China over 5 years from 2010 to 2014. All of the articles were hand researched on Chongqing VIP database between 2010 and 2014. Studies were considered eligible if the words "random", "randomly", "randomization", "randomized" were employed to describe the allocation way. Trials including animals, cadavers, trials published as abstracts and case report, trials dealing with subgroups analysis, or trials without the outcomes were excluded. In addition, eight articles selected from Orthopaedics Traumatology Surgery & Research (OTSR) between 2010 and 2014 were included in this study for comparison. The identified RCTs are analyzed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT), including the sample size calculation, allocation sequence generation, allocation concealment, blinding and handling of dropouts. A total of 222 RCTs were identified in seven core orthopaedic journals. No trials reported adequate sample size calculation, 74 (33.4%) reported adequate allocation generation, 8 (3.7%) trials reported adequate allocation concealment, 18 (8.1%) trials reported adequate blinding and 16 (7.2%) trials reported handling of dropouts. In OTSR, 1 (12.5%) trial reported adequate sample size calculation, 4 (50.0%) reported adequate allocation generation, 1 (12.5%) trials reported adequate allocation concealment, 2 (25.0%) trials reported adequate blinding and 5 (62.5%) trials reported handling of dropouts. There were statistical differences as for sample size calculation and handling of dropouts between papers from Mainland China and OTSR (P<0.05). The findings of this study show that the methodological reporting quality of RCTs in seven core orthopaedic journals from the Mainland China is far from satisfaction and it needs to further improve to keep up with the standards of the CONSORT statement. Level III case control. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

A comparison of two-coloured filter systems for treating visual reading difficulties.

PubMed

Hall, Roger; Ray, Nicola; Harries, Priscilla; Stein, John

2013-01-01

Visual disturbances that make it difficult to read text are often termed "visual stress". Coloured filters in spectacles may help some children overcome reading problems that are often caused by visual stress. It has been suggested that for optimal effect each child requires an individually prescribed colour for each eye, as determined in systems such as the "Harris Foundation" coloured filters. Alternatively, it has been argued that only blue or yellow filters, as used in the "Dyslexia Research Trust" (DRT) filter system, are necessary to affect the underlying physiology. A randomised, double blind trial with 73 delayed readers, was undertaken to compare changes in reading and spelling as well as irregular and non-word reading skills after 3 months of wearing either the Harris or the DRT filters. Reading improved significantly after wearing either type of filter (t = -8.4, p < 0.01), with 40% of the children improving their reading age by 6 months or more during the 3 month trial. However, spelling ability (t = 2.1, p = 0.05) and non-word reading (f = 4.7, p < 0.05) improved significantly more with the DRT than with the Harris filters. Education and rehabilitation professionals should therefore, consider coloured filters as an effective intervention for delayed readers experiencing visual stress. Any disability that impacts on a child's capacity to read has serious implications for academic development as well as the ability to participate independently in activities of daily living. One reading disability, generally termed "visual stress", is related to visual disturbances that make it difficult to read text. This research demonstrates the beneficial use of coloured filters for promoting visual reading capacity for children with visual stress. Professionals who are involved in the needs of children with reading delay, may like to consider the benefits that coloured filters can afford children with visual reading problems.

A comparison of two-coloured filter systems for treating visual reading difficulties

PubMed Central

Hall, Roger; Ray, Nicola; Harries, Priscilla

2013-01-01

Purpose Visual disturbances that make it difficult to read text are often termed “visual stress”. Coloured filters in spectacles may help some children overcome reading problems that are often caused by visual stress. It has been suggested that for optimal effect each child requires an individually prescribed colour for each eye, as determined in systems such as the “Harris Foundation” coloured filters. Alternatively, it has been argued that only blue or yellow filters, as used in the “Dyslexia Research Trust” (DRT) filter system, are necessary to affect the underlying physiology. Method A randomised, double blind trial with 73 delayed readers, was undertaken to compare changes in reading and spelling as well as irregular and non-word reading skills after 3 months of wearing either the Harris or the DRT filters. Results Reading improved significantly after wearing either type of filter (t = −8.4, p < 0.01), with 40% of the children improving their reading age by 6 months or more during the 3 month trial. However, spelling ability (t = 2.1, p = 0.05) and non-word reading (f = 4.7, p < 0.05) improved significantly more with the DRT than with the Harris filters. Conclusion Education and rehabilitation professionals should therefore, consider coloured filters as an effective intervention for delayed readers experiencing visual stress. Implications for Rehabilitation Any disability that impacts on a child’s capacity to read has serious implications for academic development as well as the ability to participate independently in activities of daily living. One reading disability, generally termed “visual stress”, is related to visual disturbances that make it difficult to read text. This research demonstrates the beneficial use of coloured filters for promoting visual reading capacity for children with visual stress. Professionals who are involved in the needs of children with reading delay, may like to consider the benefits that coloured filters can afford children with visual reading problems. PMID:23627538

Does early reading failure decrease children's reading motivation?

PubMed

Morgan, Paul L; Fuchs, Douglas; Compton, Donald L; Cordray, David S; Fuchs, Lynn S

2008-01-01

The authors used a pretest-posttest control group design with random assignment to evaluate whether early reading failure decreases children's motivation to practice reading. First, they investigated whether 60 first-grade children would report substantially different levels of interest in reading as a function of their relative success or failure in learning to read. Second, they evaluated whether increasing the word reading ability of 15 at-risk children would lead to gains in their motivation to read. Multivariate analyses of variance suggest marked differences in both motivation and reading practice between skilled and unskilled readers. However, bolstering at-risk children's word reading ability did not yield evidence of a causal relationship between early reading failure and decreased motivation to engage in reading activities. Instead, hierarchical regression analyses indicate a covarying relationship among early reading failure, poor motivation, and avoidance of reading.

Combined Modality Intervention for ADHD with Comorbid Reading Disorders: A Proof of Concept Study

ERIC Educational Resources Information Center

Tannock, Rosemary; Frijters, Jan C.; Martinussen, Rhonda; White, Erin Jacquelyn; Ickowicz, Abel; Benson, Nancy J.; Lovett, Maureen W.

2018-01-01

To evaluate the relative efficacy of two reading programs with and without adjunctive stimulant medication for children with attention-deficit/hyperactivity disorder and comorbid reading disorder (ADHD+RD). Sixty-five children (7-11 years in age) were assigned randomly to one of three intensive remedial academic programs (phonologically or…

Impact Evaluation: Minnesota Reading Corps K-3 Program. Appendices

ERIC Educational Resources Information Center

Markovitz, Carrie E.; Hernandez, Marc W.; Hedberg, Eric C.; Silberglitt, Benjamin

2014-01-01

Minnesota Reading Corps (MRC) is the largest AmeriCorps State program in the country. The goal of MRC is to ensure that students become successful readers and meet reading proficiency targets by the end of the third grade. Starting in 2011, the "Corporation for National and Community Service" (CNCS) sponsored a randomized controlled…

Integrating Reading Instruction into Vocational Agriculture Classes. Miscellaneous Publication 586. Contribution Number 3813.

ERIC Educational Resources Information Center

Sullivan, Dorothy D.; Cardozier, V.R.

An experiment was conducted to determine whether special reading instruction integrated with agricultural instruction would result in improved reading ability and increased achievement in subject matter. random assignment was made of vocational agriculture classes in 12 Maryland schools to experimental and control groups. Units on soil sampling…

Experience Corps: A dual trial to promote the health of older adults and children's academic success

PubMed Central

Fried, Linda P.; Carlson, Michelle C.; McGill, Sylvia; Seeman, Teresa; Xue, Qian-Li; Frick, Kevin; Tan, Erwin; Tanner, Elizabeth K.; Barron, Jeremy; Frangakis, Constantine; Piferi, Rachel; Martinez, Iveris; Gruenewald, Tara; Martin, Barbara K.; Berry-Vaughn, Laprisha; Stewart, John; Dickersin, Kay; Willging, Paul R.; Rebok, George W.

2014-01-01

Background As the population ages, older adults are seeking meaningful, and impactful, post-retirement roles. As a society, improving the health of people throughout longer lives is a major public health goal. This paper presents the design and rationale for an effectiveness trial of Experience Corps™, an intervention created to address both these needs. This trial evaluates (1) whether senior volunteer roles within Experience Corps™ beneficially impact children's academic achievement and classroom behavior in public elementary schools and (2) impact on the health of volunteers. Methods Dual evaluations of (1) an intention-to-treat trial randomizing eligible adults 60 and older to volunteer service in Experience Corps™, or to a control arm of usual volunteering opportunities, and (2) a comparison of eligible public elementary schools receiving Experience Corps™ to matched, eligible control schools in a 1:1 control:intervention school ratio. Outcomes For older adults, the primary outcome is decreased disability in mobility and Instrumental Activities of Daily Living (IADL). Secondary outcomes are decreased frailty, falls, and memory loss; slowed loss of strength, balance, walking speed, cortical plasticity, and executive function; objective performance of IADLs; and increased social and psychological engagement. For children, primary outcomes are improved reading achievement and classroom behavior in Kindergarten through the 3rd grade; secondary outcomes are improvements in school climate, teacher morale and retention, and teacher perceptions of older adults. Summary This trial incorporates principles and practices of community-based participatory research and evaluates the dual benefit of a single intervention, versus usual opportunities, for two generations: older adults and children. PMID:23680986

Repeated Reading of CD-ROM Storybook as a Support for Emergent Literacy: A Developmental Perspective in Two SES Groups

ERIC Educational Resources Information Center

Korat, Ofra; Blau, Hila

2010-01-01

We investigated the effect of repeated readings of an electronic book (e-book) on pre-kindergarten and kindergarten children from low (n = 127) and middle (n = 120) SES groups. Children were randomly assigned to one of three options: reading an e-book in five sessions, reading an e-book in three sessions, or receiving the regular kindergarten…

Can reading-specific training stimuli improve the effect of perceptual learning on peripheral reading speed?

PubMed

Bernard, Jean-Baptiste; Arunkumar, Amit; Chung, Susana T L

2012-08-01

In a previous study, Chung, Legge, and Cheung (2004) showed that training using repeated presentation of trigrams (sequences of three random letters) resulted in an increase in the size of the visual span (number of letters recognized in a glance) and reading speed in the normal periphery. In this study, we asked whether we could optimize the benefit of trigram training on reading speed by using trigrams more specific to the reading task (i.e., trigrams frequently used in the English language) and presenting them according to their frequencies of occurrence in normal English usage and observers' performance. Averaged across seven observers, our training paradigm (4 days of training) increased the size of the visual span by 6.44 bits, with an accompanied 63.6% increase in the maximum reading speed, compared with the values before training. However, these benefits were not statistically different from those of Chung, Legge, and Cheung (2004) using a random-trigram training paradigm. Our findings confirm the possibility of increasing the size of the visual span and reading speed in the normal periphery with perceptual learning, and suggest that the benefits of training on letter recognition and maximum reading speed may not be linked to the types of letter strings presented during training. Copyright © 2012 Elsevier Ltd. All rights reserved.

A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial.

PubMed

Chesnut, Randall M; Bleck, Thomas P; Citerio, Giuseppe; Classen, Jan; Cooper, D James; Coplin, William M; Diringer, Michael N; Grände, Per-Olof; Hemphill, J Claude; Hutchinson, Peter J; Le Roux, Peter; Mayer, Stephan A; Menon, David K; Myburgh, John A; Okonkwo, David O; Robertson, Claudia S; Sahuquillo, Juan; Stocchetti, Nino; Sung, Gene; Temkin, Nancy; Vespa, Paul M; Videtta, Walter; Yonas, Howard

2015-11-15

Widely-varying published and presented analyses of the Benchmark Evidence From South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial of intracranial pressure (ICP) monitoring have suggested denying trial generalizability, questioning the need for ICP monitoring in severe traumatic brain injury (sTBI), re-assessing current clinical approaches to monitored ICP, and initiating a general ICP-monitoring moratorium. In response to this dissonance, 23 clinically-active, international opinion leaders in acute-care sTBI management met to draft a consensus statement to interpret this study. A Delphi method-based approach employed iterative pre-meeting polling to codify the group's general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of more than 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83% to 100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that the BEST TRIP trial: 1) studied protocols, not ICP-monitoring per se; 2) applies only to those protocols and specific study groups and should not be generalized to other treatment approaches or patient groups; 3) strongly calls for further research on ICP interpretation and use; 4) should be applied cautiously to regions with much different treatment milieu; 5) did not investigate the utility of treating monitored ICP in the specific patient group with established intracranial hypertension; 6) should not change the practice of those currently monitoring ICP; and 7) provided a protocol, used in non-monitored study patients, that should be considered when treating without ICP monitoring. Consideration of these statements can clarify study interpretation.

Communication skills course in an Indian undergraduate dental curriculum: a randomized controlled trial.

PubMed

Sangappa, Sunila B; Tekian, Ara

2013-08-01

This study assessed the impact of a course on communication skills for third-year undergraduate dental students at a dental institute in India. A randomized pretest, posttest controlled trial was conducted with all the students from four cohorts of third-year dental undergraduate students, divided into an intervention group (n=30) and a control group (n=30). The course was developed using Kern's six-step approach to curriculum development. Needs assessment was ascertained, and readings, lectures, and role-plays with real and simulated patients were implemented. Encounters of students during two patient interviews (simulated and real) were rated by two raters using a twenty-seven-item dental consultation communication checklist with a rating scale 0 to 3. Students completed a questionnaire regarding their acceptance of the course. A 2×2 (group × time) ANOVA with group as a between-subjects factor (control vs. experimental) and time as a within-subjects factor (pre vs. post) was performed. The two groups did not differ at pretest but differed significantly at posttest. This study showed that simply attending to patients during a clinical course did not improve professional communication skills. In contrast, the implementation of a course on communication skills did improve the students' dentist-patient interactions. Integrating the teaching and development of a relevant, outcome-based course on communication skills provided clear evidence of communication skills acquisition among these dental students. The course could be introduced in other Indian dental schools.

Implementation strategies for guidelines at ICUs: a systematic review.

PubMed

Jordan, Portia; Mpasa, Ferestas; Ten Ham-Baloyi, Wilma; Bowers, Candice

2017-05-08

Purpose The purpose of this paper is to critically analyze empirical studies related to the implementation strategies for clinical practice guidelines (CPGs) in intensive care units (ICUs). Design/methodology/approach A systematic review with a narrative synthesis adapted from Popay et al.'s method for a narrative synthesis was conducted. A search using CINAHL, Google Scholar, Academic search complete, Cochrane Register for Randomized Controlled Trials, MEDLINE via PUBMED and grey literature was conducted in 2014 and updated in 2016 (August). After reading the abstracts, titles and full-text articles, 11 ( n=11) research studies met the inclusion criteria. Findings After critical appraisal, using the Joanna Briggs Critical Appraisal Tools, eight randomized controlled trials conducted in adult and neonatal ICUs using implementation strategies remained. Popay et al.'s method for narrative synthesis was adapted and used to analyze and synthesize the data and formulate concluding statements. Included studies found that multi-faceted strategies appear to be more effective than single strategies. Strategies mostly used were printed educational materials, information/ sessions, audit, feedback, use of champion leaders, educational outreach visits, and computer or internet usage. Practical training, monitoring visits and grand rounds were less used. Practical implications Findings can be used by clinicians to implement the best combination of multi-faceted implementation strategies in the ICUs in order to enhance the optimal use of CPGs. Originality/value No systematic review was previously done on the implementation strategies that should be used best for optimal CPG implementation in the ICU.

Controlling indoor allergens.

PubMed

Custovic, Adnan; Murray, Clare S; Gore, Robin B; Woodcock, Ashley

2002-05-01

Reading of this article reinforces the reader's knowledge of the role of allergen exposure in relation to asthma and its severity, as well as the relevance of allergen avoidance in the treatment of asthma. Initial literature search for existing evidence-based guidelines, reviews, and meta-analyses was carried out, and further literature searches were performed to review individual randomized controlled trials. Evidence level was graded according to the Scottish Intercollegiate Guidelines Network recommendations. There is good evidence for the link between mite and cockroach allergen exposure and sensitization, and between sensitization and asthma. For pet allergens, some studies found that exposure to pets in early life was associated with specific immunoglobulin E sensitization and allergic disease later in childhood, whereas others reported a protective effect. The effectiveness of allergen reduction in the treatment of asthma is suggested by studies in which the patients improve substantially when moved into the low-allergen environment of hospitals or high-altitude sanatoria. Because of limitations in the design of the most clinical of studies, we do not yet have a conclusive answer on the effectiveness of domestic aeroallergen avoidance. Minimizing the impact of identified environmental risk factors is an important first step to reduce the severity of asthma. Although environmental control is difficult, it should be an integral part of the overall management of sensitized patients. However, what is unclear is which patients would benefit and by how much, and whether the intervention is cost-effective. These questions will be answered satisfactorily only by large randomized trials.

Internet-based monitoring of asthma symptoms, peak flow meter readings, and absence data in a school-based clinical trial

PubMed Central

McClure, Leslie A; Harrington, Kathy F; Graham, Holli; Gerald, Lynn B

2009-01-01

Background Asthma is the most common chronic childhood disease and has significant impact on morbidity and mortality in children. Proper adherence to asthma medication has been shown to reduce morbidity among those with asthma; however, adherence to medications is known to be low, especially among low-income urban populations. We conducted a randomized clinical trial to examine the effectiveness of an intervention designed to increase adherence to asthma medication among children with asthma that required daily collection of data. Purpose and Methods A specifically designed web-based data collection system, the Asthma Agents System, was used to collect daily data from participant children at school. These data were utilized to examine the intervention’s effectiveness in reducing the frequency of asthma exacerbations. This study examines the Asthma Agents System’s effect on the frequency of missing data. Data collection methods are discussed in detail, as well as the processes for retrieving missing data. Results For the 290 children randomized, 97% of the daily data expected were available. Of the outcome data retrieved via the Asthma Agents System, 5% of those expected were missing during the period examined. Limitations Challenges encountered in this study include issues regarding the use of technology in urban school settings, transfer of data between study sites, and availability of data during school breaks. Conclusions Use of the Asthma Agents System resulted in lower rates of missing data than rates reported elsewhere in the literature. PMID:18283077

Predictive Validity of a Cigarette Purchase Task in a Randomized Controlled Trial of Contingent Vouchers for Smoking in Individuals With Substance Use Disorders

PubMed Central

Mackillop, James; Murphy, Cara M.; Martin, Rosemarie A.; Stojek, Monika; Tidey, Jennifer W.; Colby, Suzanne M.

2016-01-01

Abstract Introduction: A cigarette purchase task (CPT) is a behavioral economic measure of the reinforcing value of smoking in monetary terms (ie, cigarette demand). This study investigated whether cigarette demand predicted response to contingent monetary rewards for abstinence among individuals with substance use disorders. It also sought to replicate evidence for greater price sensitivity at whole-dollar pack price transitions (ie, left-digit effects). Methods: Participants ( N = 338) were individuals in residential substance use disorder treatment who participated in a randomized controlled trial that compared contingent vouchers to noncontingent vouchers for smoking abstinence. Baseline demand indices were used to predict number of abstinent days during the 14-day voucher period (after the reduction lead-in) and at 1 and 3 months afterward. Results: Demand indices correlated with measures of smoking and nicotine dependence. As measured by elasticity, intensity and Omax , higher demand significantly predicted fewer abstinent exhaled carbon monoxide readings during voucher period for individuals in the noncontingent vouchers condition. Breakpoint exhibited a trend-level association with abstinent exhaled carbon monoxide readings. Demand indices did not predict abstinence in the contingent vouchers group, and did not predict abstinence at 1- and 3-month follow-ups. Left-digit price transitions were associated with significantly greater reductions in consumption. Conclusions: The association of cigarette demand with smoking behavior only in the group for whom abstinence was not incentivized indicates that CPT assesses the value of smoking more than the value of money per se and that vouchers counteract the effects of the intrinsic reinforcing value of cigarettes. Results provide initial short-term evidence of predictive validity for the CPT indices. Implications: This study provides the first evidence of the validity of the CPT for predicting early response to brief advice for smoking cessation plus nicotine replacement in smokers with substance dependence. However, demand for cigarettes did not predict voucher-based treatment response, indicating that incentives serve as a powerful motivator not to smoke that acts in opposition to the intrinsic reinforcing value of cigarettes and that the indices reflect the value of smoking more than the value of money per se. PMID:26498173

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

ERIC Educational Resources Information Center

Coalition for Evidence-Based Policy, 2005

2005-01-01

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

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

ERIC Educational Resources Information Center

Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2016-01-01

Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

Identifying Learning Patterns of Children at Risk for Specific Reading Disability

PubMed Central

Barbot, Baptiste; Krivulskaya, Suzanna; Hein, Sascha; Reich, Jodi; Thuma, Philip E.; Grigorenko, Elena L.

2016-01-01

Differences in learning patterns of vocabulary acquisition in children at risk (+SRD) and not at risk (SRD) for Specific Reading Disability (SRD) were examined using a microdevelopmental paradigm applied to the multi-trial Foreign Language Learning Task (FLLT; Baddeley et al., 1995). The FLLT was administered to 905 children from rural Chitonga-speaking Zambia. A multi-group Latent Growth Curve Model (LGCM) was implemented to study interindividual differences in intraindividual change across trials. Results showed that the +SRD group recalled fewer words correctly in the first trial, learned at a slower rate during the subsequent trials, and demonstrated a more linear learning pattern compared to the SRD group. This study illustrates the promise of LGCM applied to multi-trial learning tasks, by isolating three components of the learning process (initial recall, rate of learning, and functional pattern of learning). Implications of this microdevelopmental approach to SRD research in low-to-middle income countries are discussed. PMID:26037654