Influence of form structure on the anesthesia preoperative evaluation.

PubMed

Marco, Alan P; Buchman, Debra; Lancz, Colleen

2003-09-01

To determine the impact of changes in form design on the capture of administrative and clinical data elements. Randomized retrospective chart review. Academic health center. Patients undergoing surgical procedures in the operating rooms at Medical College Hospital. The principal intervention was the implementation of a newly designed anesthesiology preoperative evaluation form with the intent to improve data capture. Charts were reviewed for the presence or absence of the following indicators: Addressograph Stamp, Proposed Surgery, Current Medications, Medication Doses/Frequency, Allergies, ASA Physical Status, Anesthesia Plan, Attending Note, and fasting (NPO) Status. Completion of Proposed Surgery and ASA Physical Status was lower for the structured form. Completion of Attending Notes was higher with the new form. Medication Doses were more often completed, but they remained below desired levels on the new form. Design of a form can have a significant impact on the completion rate of form elements. Visual cues such as a labeled space for medication doses may improve the completion of these elements. Design layout can also have an influence on completion. In this case, changes to the layout may have impeded the completion rate for ASA Physical Status.

A primer on stand and forest inventory designs

Treesearch

H. Gyde Lund; Charles E. Thomas

1989-01-01

Covers designs for the inventory of stands and forests in detail and with worked-out examples. For stands, random sampling, line transects, ricochet plot, systematic sampling, single plot, cluster, subjective sampling and complete enumeration are discussed. For forests inventory, the main categories are subjective sampling, inventories without prior stand mapping,...

School Happiness and School Success: An Investigation across Multiple Grade Levels.

ERIC Educational Resources Information Center

Parish, Joycelyn Gay; Parish, Thomas S.; Batt, Steve

A total of 572 randomly selected sixth-grade students and 908 randomly selected ninth-grade students from a large metropolitan school district in the Midwest were asked to complete a series of survey questions designed to measure the extent to which they were happy while at school, as well as questions concerning the extent to which they treated…

Effects of Animation on Naming and Identification across Two Graphic Symbol Sets Representing Verbs and Prepositions

ERIC Educational Resources Information Center

Schlosser, Ralf W.; Koul, Rajinder; Shane, Howard; Sorce, James; Brock, Kristofer; Harmon, Ashley; Moerlein, Dorothy; Hearn, Emilia

2014-01-01

Purpose: The effects of animation on naming and identification of graphic symbols for verbs and prepositions were studied in 2 graphic symbol sets in preschoolers. Method: Using a 2 × 2 × 2 × 3 completely randomized block design, preschoolers across three age groups were randomly assigned to combinations of symbol set (Autism Language Program…

Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system.

PubMed

Engel, Charles C; Bray, Robert M; Jaycox, Lisa H; Freed, Michael C; Zatzick, Doug; Lane, Marian E; Brambilla, Donald; Rae Olmsted, Kristine; Vandermaas-Peeler, Russ; Litz, Brett; Tanielian, Terri; Belsher, Bradley E; Evatt, Daniel P; Novak, Laura A; Unützer, Jürgen; Katon, Wayne J

2014-11-01

War-related trauma, posttraumatic stress disorder (PTSD), depression and suicide are common in US military members. Often, those affected do not seek treatment due to stigma and barriers to care. When care is sought, it often fails to meet quality standards. A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system. The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care. The STEPS-UP Trial (STepped Enhancement of PTSD Services Using Primary Care) is a 6 installation (18 clinic) randomized effectiveness trial in the US military health system. Study rationale, design, enrollment and sample characteristics are summarized. Military members attending primary care with suspected PTSD, depression or both were referred to care management and recruited for the trial (2592), and 1041 gave permission to contact for research participation. Of those, 666 (64%) met eligibility criteria, completed baseline assessments, and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care. Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP. Research reassessments occurred at 3-, 6-, and 12-months. Baseline characteristics were similar across the two intervention groups. STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system, assessing how an implementation model affects collaborative care impact on mental health outcomes. It promises lessons for health system change. Copyright © 2014 Elsevier Inc. All rights reserved.

Quasi-experimental designs in practice-based research settings: design and implementation considerations.

PubMed

Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

2011-01-01

Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

A Randomized Crossover Study of Web-Based Media Literacy to Prevent Smoking

ERIC Educational Resources Information Center

Shensa, Ariel; Phelps-Tschang, Jane; Miller, Elizabeth; Primack, Brian A.

2016-01-01

Feasibly implemented Web-based smoking media literacy (SML) programs have been associated with improving SML skills among adolescents. However, prior evaluations have generally had weak experimental designs. We aimed to examine program efficacy using a more rigorous crossover design. Seventy-two ninth grade students completed a Web-based SML…

Designing Guidance for Interpreting Dynamic Visualizations: Generating versus Reading Explanations

ERIC Educational Resources Information Center

Ryoo, Kihyun; Linn, Marcia C.

2014-01-01

We compared designs of guidance to support students while interacting with dynamic visualizations of complex scientific phenomena in inquiry instruction. Three hundred thirty-two 7th-grade students were randomly assigned to either a reading or a generating condition and completed a web-based inquiry unit focusing on energy concepts in…

Morpho-physiological characterization of cold-and pre-flowering drought tolerance in grain Sorghum (Sorghum bicolor L. Moench) inbreds

USDA-ARS?s Scientific Manuscript database

Aim: The relationships between early-season cold temperature germination and preflowering drought stress in eight grain sorghum inbreds were assessed using morphophysiological traits. Study Design: Field was laid out in a randomized complete block design. Place and Duration: The experiment was condu...

A Multicenter, Rater-Blinded, Randomized Controlled Study of Auditory Processing-Focused Cognitive Remediation Combined With Open-Label Lurasidone in Patients With Schizophrenia and Schizoaffective Disorder.

PubMed

Kantrowitz, Joshua T; Sharif, Zafar; Medalia, Alice; Keefe, Richard S E; Harvey, Philip; Bruder, Gerard; Barch, Deanna M; Choo, Tse; Lee, Seonjoo; Lieberman, Jeffrey A

2016-06-01

Small-scale studies of auditory processing cognitive remediation programs have demonstrated efficacy in schizophrenia. We describe a multicenter, rater-blinded, randomized, controlled study of auditory-focused cognitive remediation, conducted from June 24, 2010, to June 14, 2013, and approved by the local institutional review board at all sites. Prior to randomization, participants with schizophrenia (DSM-IV-TR) were stabilized on a standardized antipsychotic regimen (lurasidone [40-160 mg/d]), followed by randomization to adjunctive cognitive remediation: auditory focused (Brain Fitness) versus control (nonspecific video games), administered 1-2 times weekly for 30 sessions. Coprimary outcome measures included MATRICS Consensus Cognitive Battery (MCCB) and the University of California, San Diego, Performance-Based Skills Assessment-Brief scale. 120 participants were randomized and completed at least 1 auditory-focused cognitive remediation (n = 56) or video game control session (n = 64). 74 participants completed ≥ 25 sessions and postrandomization assessments. At study completion, the change from prestabilization was statistically significant for MCCB composite score (d = 0.42, P < .0001) across groups. Participants randomized to auditory-focused cognitive remediation had a trend-level higher mean MCCB composite score compared to participants randomized to control cognitive remediation (P = .08). After controlling for scores at the time of randomization, there were no significant between-treatment group differences at study completion. Auditory processing cognitive remediation combined with lurasidone did not lead to differential improvement over nonspecific video games. Across-group improvement from prestabilization baseline to study completion was observed, but since all participants were receiving lurasidone open label, it is difficult to interpret the source of these effects. Future studies comparing both pharmacologic and behavioral cognitive enhancers should consider a 2 × 2 design, using a control for both the medication and the cognitive remediation. ClinicalTrials.gov identifier: NCT01173874. © Copyright 2016 Physicians Postgraduate Press, Inc.

The Impact of Silhouette Randomization on the Results of Figure Rating Scales

ERIC Educational Resources Information Center

Duncan, Michael J.; Dodd, Lorna J.; Al-Nakeeb, Yahya

2005-01-01

This study was designed to examine the impact of silhouette randomization on the responses to rating scales developed to rate the perceived current and ideal body shape, as well as body dissatisfaction. Seventy students (30 men and 40 women), ages 18 to 43 (M [plus or minus] SD = 22.1 [plus or minus] 5.7) years, completed the Stunkard, Sorensen,…

The Effectiveness of a Group Triple P with Chinese Parents Who Have a Child with Developmental Disabilities: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Fan, Angel; Sanders, Matthew R.

2013-01-01

The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on…

The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial

PubMed Central

2012-01-01

Background The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS) in athletes in a non-military setting was the same. Methods The study design was randomized and multi-centered. Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion. 81 athletes were assessed for eligibility of which 74 athletes were included and randomized to three treatment groups. Group one performed a graded running program, group two performed a graded running program with additional stretching and strengthening exercises for the calves, while group three performed a graded running program with an additional sports compression stocking. The primary outcome measure was: time to complete a running program (able to run 18 minutes with high intensity) and secondary outcome was: general satisfaction with treatment. Results 74 Athletes were randomized and included of which 14 did not complete the study due a lack of progress (18.9%). The data was analyzed on an intention-to-treat basis. Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups. Conclusion This was the first randomized trial on the treatment of MTSS in athletes in a non-military setting. No differences were found between the groups for the time to complete a running program. Trial registration CCMO; NL23471.098.08 PMID:22464032

Internet-Based Interventions Have Potential to Affect Short-Term Mediators and Indicators of Dietary Behavior of Young Adults

ERIC Educational Resources Information Center

Park, Amanda; Nitzke, Susan; Kritsch, Karen; Kattelmann, Kendra; White, Adrienne; Boeckner, Linda; Lohse, Barbara; Hoerr, Sharon; Greene, Geoffrey; Zhang, Zhumin

2008-01-01

Objective: Evaluate a theory-based, Internet-delivered nutrition education module. Design: Randomized, treatment-control design with pre-post intervention assessments. Setting and Participants: Convenience sample of 160 young adults (aged 18-24) recruited by community educators in 4 states. Study completers (n = 96) included a mix of…

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally.

PubMed

Solomon, Todd M; Leech, Jarrett; deBros, Guy B; Murphy, Cynthia A; Budson, Andrew E; Vassey, Elizabeth A; Solomon, Paul R

2016-03-01

Alpha BRAIN® is a nootropic supplement that purports to enhance cognitive functioning in healthy adults. The goal of this study was to investigate the efficacy of this self-described cognitive enhancing nootropic on cognitive functioning in a group of healthy adults by utilizing a randomized, double blind, placebo-controlled design. A total of 63-treatment naïve individuals between 18 and 35 years of age completed the randomized, double-blind, placebo controlled trial. All participants completed a 2-week placebo run in before receiving active product, Alpha BRAIN® or new placebo, for 6 weeks. Participants undertook a battery of neuropsychological tests at randomization and at study completion. Primary outcome measures included a battery of neuropsychological tests and measures of sleep. Compared with placebo, Alpha BRAIN® significantly improved on tasks of delayed verbal recall and executive functioning. Results also indicated significant time-by-group interaction in delayed verbal recall for the Alpha BRAIN® group. The use of Alpha BRAIN® for 6 weeks significantly improved recent verbal memory when compared with controls, in a group of healthy adults. While the outcome of the study is encouraging, this is the first randomized controlled trial of Alpha BRAIN®, and the results merit further study. Copyright © 2016 John Wiley & Sons, Ltd.

Determining the Effects That the Order of Abstraction and Type of Reflection Have on Content Knowledge When Teaching Experientially: An Exploratory Experiment

ERIC Educational Resources Information Center

Baker, Marshall A.; Brown, Nicholas R.; Blackburn, J. Joey; Robinson, J. Shane

2014-01-01

The purpose of this experimental study was to determine the effects of order of abstraction and type of reflection on student knowledge acquisition. Students were assigned randomly to one of four treatment combinations in the completely randomized 2 x 2 design which included either abstraction prior to or directly after an experience, and either…

Chaos and complexity by design

DOE PAGES

Roberts, Daniel A.; Yoshida, Beni

2017-04-20

We study the relationship between quantum chaos and pseudorandomness by developing probes of unitary design. A natural probe of randomness is the “frame poten-tial,” which is minimized by unitary k-designs and measures the 2-norm distance between the Haar random unitary ensemble and another ensemble. A natural probe of quantum chaos is out-of-time-order (OTO) four-point correlation functions. We also show that the norm squared of a generalization of out-of-time-order 2k-point correlators is proportional to the kth frame potential, providing a quantitative connection between chaos and pseudorandomness. In addition, we prove that these 2k-point correlators for Pauli operators completely determine the k-foldmore » channel of an ensemble of unitary operators. Finally, we use a counting argument to obtain a lower bound on the quantum circuit complexity in terms of the frame potential. This provides a direct link between chaos, complexity, and randomness.« less

The effectiveness of a Group Triple P with Chinese parents who have a child with developmental disabilities: a randomized controlled trial.

PubMed

Leung, Cynthia; Fan, Angel; Sanders, Matthew R

2013-03-01

The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on child behaviour, parental stress, dysfunctional discipline styles and parental conflict before and after program completion by the Intervention group. Intervention group participants also completed these same measures six months after program completion. Compared to the Waitlist Control group, parents receiving Group Triple P reported significantly lower levels of child behaviour problems, parental stress, dysfunctional discipline style and parental conflict scores. The Intervention group participants maintained their gains six months after program completion. The results provided promising evidence for the Level 4 Group Triple P as an effective intervention program for Chinese parents who have preschool aged children with developmental disabilities. Copyright © 2012 Elsevier Ltd. All rights reserved.

The Effects of Follow-up and Peer Interaction on Quality of Performance and Completion of Online Professional Development

ERIC Educational Resources Information Center

Green, Marybeth; Cifuentes, Lauren

2011-01-01

This study examined the effects of the inclusion of online follow-up and online peer interaction with a face-to face workshop on quality of support plan and completion of a support plan by Texas school librarians. The study used a posttest-only control group experimental design with randomly assigned self-selected participants. Three online…

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. Methods/Design We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. Discussion This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. Clinical trial registration ClinicalTrials.gov NCT02054598. PMID:25004983

Alcohol assessment among college students using wireless mobile technology.

PubMed

Bernhardt, Jay M; Usdan, Stuart; Mays, Darren; Martin, Ryan; Cremeens, Jennifer; Arriola, Kimberly Jacob

2009-09-01

This study used a two-group randomized design to assess the validity of measuring self-reported alcohol consumption among college students using the Handheld Assisted Network Diary (HAND), a daily diary assessment administered using wireless mobile devices. A convenience sample of college students was recruited at a large, public university in the southeastern United States and randomized into two groups. A randomly assigned group of 86 students completed the daily HAND assessment during the 30-day study and a Timeline Followback (TLFB) at 30-day follow-up. A randomly assigned group of 82 students completed the paper-and-pencil Daily Social Diary (DSD) over the same study period. Data from the daily HAND assessment were compared with the TLFB completed at follow-up by participants who completed the HAND using 95% limits of agreement analysis. Furthermore, individual growth models were used to examine differences between the HAND and DSD by comparing the total drinks, drinking days, and drinks per drinking day captured by the two assessments over the study period. Results suggest that the HAND captured similar levels of alcohol use compared with the TLFB completed at follow-up by the same participants. In addition, comparisons of the two study groups suggest that, controlling for baseline alcohol use and demographics, the HAND assessment captured similar levels of total drinks, drinking days, and drinks per drinking day as the paper-and-pencil DSD. The study findings support the validity of wireless mobile devices as a daily assessment of alcohol use among college students.

Assessing the quality of a non-randomized pragmatic trial for primary prevention of falls among older adults.

PubMed

Albert, Steven M; Edelstein, Offer; King, Jennifer; Flatt, Jason; Lin, Chyongchiou J; Boudreau, Robert; Newman, Anne B

2015-01-01

Current approaches to falls prevention mostly rely on secondary and tertiary prevention and target individuals at high risk of falls. An alternative is primary prevention, in which all seniors are screened, referred as appropriate, and educated regarding falls risk. Little information is available on research designs that allow investigation of this approach in the setting of aging services delivery, where randomization may not be possible. Healthy Steps for Older Adults, a statewide program of the Pennsylvania (PA) Department of Aging, involves a combination of education about falls and screening for balance problems, with referral to personal physicians and home safety assessments. We developed a non-randomized statewide trial, Falls Free PA, to assess its effectiveness in reducing falls incidence over 12 months. We recruited 814 seniors who completed the program (503 first-time participants, 311 people repeating the program) and 1,020 who did not participate in the program, from the same sites. We assessed the quality of this non-randomized design by examining recruitment, follow-up across study groups, and comparability at baseline. Of older adults approached in senior centers, 90.5 % (n = 2,219) signed informed consent, and 1,834 (82.4 %) completed baseline assessments and were eligible for follow-up. Attrition in the three groups over 12 months was low and non-differential (<10 % for withdrawal and <2 % for other loss to follow-up). Median follow-up, which involved standardized monthly assessment of falls, was 10 months in all study groups. At baseline, the groups did not differ in measures of health or falls risk factors. Comparable status at baseline, recruitment from common sites, and similar experience with retention suggest that the non-randomized design will be effective for assessment of this approach to primary prevention of falls.

Enhancing Adherence among Older African American Men Enrolled in a Longitudinal Cancer Screening Trial

ERIC Educational Resources Information Center

Ford, Marvella E.; Havstad, Suzanne; Vernon, Sally W.; Davis, Shawna D.; Kroll, David; Lamerato, Lois; Swanson, G. Marie

2006-01-01

Purpose: The purpose of this study was to enhance adherence among older (aged 55 years and older) African American men enrolled in a cancer screening trial for prostate, lung, and colorectal cancer. For this study, we defined "adherence" as completing the trial screenings. Design and Methods: We used a randomized trial design. Case managers…

A pilot cluster randomized controlled trial of structured goal-setting following stroke.

PubMed

Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

2012-04-01

To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

Smoking relapse-prevention intervention for cancer patients: Study design and baseline data from the surviving SmokeFree randomized controlled trial.

PubMed

Díaz, Diana B; Brandon, Thomas H; Sutton, Steven K; Meltzer, Lauren R; Hoehn, Hannah J; Meade, Cathy D; Jacobsen, Paul B; McCaffrey, Judith C; Haura, Eric B; Lin, Hui-Yi; Simmons, Vani N

2016-09-01

Continued smoking after a cancer diagnosis contributes to several negative health outcomes. Although many cancer patients attempt to quit smoking, high smoking relapse rates have been observed. This highlights the need for a targeted, evidence-based smoking-relapse prevention intervention. The design, method, and baseline characteristics of a randomized controlled trial assessing the efficacy of a self-help smoking-relapse prevention intervention are presented. Cancer patients who had recently quit smoking were randomized to one of two conditions. The Usual Care (UC) group received the institution's standard of care. The smoking relapse-prevention intervention (SRP) group received standard of care, plus 8 relapse-prevention booklets mailed over a 3month period, and a targeted educational DVD developed specifically for cancer patients. Four hundred and fourteen participants were enrolled and completed a baseline survey. Primary outcomes will be self-reported smoking status at 6 and 12-months after baseline. Biochemical verification of smoking status was completed for a subsample. If found to be efficacious, this low-cost intervention could be easily disseminated with significant potential for reducing the risk of negative cancer outcomes associated with continued smoking. Copyright © 2016 Elsevier Inc. All rights reserved.

Using GIS to generate spatially balanced random survey designs for natural resource applications.

PubMed

Theobald, David M; Stevens, Don L; White, Denis; Urquhart, N Scott; Olsen, Anthony R; Norman, John B

2007-07-01

Sampling of a population is frequently required to understand trends and patterns in natural resource management because financial and time constraints preclude a complete census. A rigorous probability-based survey design specifies where to sample so that inferences from the sample apply to the entire population. Probability survey designs should be used in natural resource and environmental management situations because they provide the mathematical foundation for statistical inference. Development of long-term monitoring designs demand survey designs that achieve statistical rigor and are efficient but remain flexible to inevitable logistical or practical constraints during field data collection. Here we describe an approach to probability-based survey design, called the Reversed Randomized Quadrant-Recursive Raster, based on the concept of spatially balanced sampling and implemented in a geographic information system. This provides environmental managers a practical tool to generate flexible and efficient survey designs for natural resource applications. Factors commonly used to modify sampling intensity, such as categories, gradients, or accessibility, can be readily incorporated into the spatially balanced sample design.

The effect of parent education program for preschool children with developmental disabilities: A randomized controlled trial.

PubMed

Leung, Cynthia; Chan, Stanley; Lam, Tiney; Yau, Sharon; Tsang, Sandra

2016-09-01

This study aimed to evaluate the efficacy of a parent education program, the Happy Parenting program, for Chinese preschool children with developmental disabilities. This study adopted randomized controlled trial design without blinding. Participants were randomized into intervention group (n=62) who were offered the Happy Parenting program delivered by educational psychologists and trainee educational psychologists, and a control group (n=57) who were offered a parent talk after the intervention group had completed treatment. Parent participants were requested to complete questionnaires on their children's behavior, their parenting stress, and discipline strategies. Analysis was by intention-to-treat. The results indicated significant decrease in child problem behaviors, parenting stress and dysfunctional discipline strategies in the intervention group at post-intervention. This study provided promising evidence on the effectiveness of a parent education program, the Happy Parenting program, for Chinese preschool children with developmental disabilities. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of language of assessment on the measurement of acculturation: measurement equivalence and cultural frame switching.

PubMed

Schwartz, Seth J; Benet-Martínez, Verónica; Knight, George P; Unger, Jennifer B; Zamboanga, Byron L; Des Rosiers, Sabrina E; Stephens, Dionne P; Huang, Shi; Szapocznik, José

2014-03-01

The present study used a randomized design, with fully bilingual Hispanic participants from the Miami area, to investigate 2 sets of research questions. First, we sought to ascertain the extent to which measures of acculturation (Hispanic and U.S. practices, values, and identifications) satisfied criteria for linguistic measurement equivalence. Second, we sought to examine whether cultural frame switching would emerge--that is, whether latent acculturation mean scores for U.S. acculturation would be higher among participants randomized to complete measures in English and whether latent acculturation mean scores for Hispanic acculturation would be higher among participants randomized to complete measures in Spanish. A sample of 722 Hispanic students from a Hispanic-serving university participated in the study. Participants were first asked to complete translation tasks to verify that they were fully bilingual. Based on ratings from 2 independent coders, 574 participants (79.5% of the sample) qualified as fully bilingual and were randomized to complete the acculturation measures in either English or Spanish. Theoretically relevant criterion measures--self-esteem, depressive symptoms, and personal identity--were also administered in the randomized language. Measurement equivalence analyses indicated that all of the acculturation measures--Hispanic and U.S. practices, values, and identifications-met criteria for configural, weak/metric, strong/scalar, and convergent validity equivalence. These findings indicate that data generated using acculturation measures can, at least under some conditions, be combined or compared across languages of administration. Few latent mean differences emerged. These results are discussed in terms of the measurement of acculturation in linguistically diverse populations. 2014 APA

Effects of Language of Assessment on the Measurement of Acculturation: Measurement Equivalence and Cultural Frame Switching

PubMed Central

Schwartz, Seth J.; Benet-Martínez, Verónica; Knight, George P.; Unger, Jennifer B.; Zamboanga, Byron L.; Des Rosiers, Sabrina E.; Stephens, Dionne; Huang, Shi; Szapocznik, José

2014-01-01

The present study used a randomized design, with fully bilingual Hispanic participants from the Miami area, to investigate two sets of research questions. First, we sought to ascertain the extent to which measures of acculturation (heritage and U.S. practices, values, and identifications) satisfied criteria for linguistic measurement equivalence. Second, we sought to examine whether cultural frame switching would emerge – that is, whether latent acculturation mean scores for U.S. acculturation would be higher among participants randomized to complete measures in English, and whether latent acculturation mean scores for Hispanic acculturation would be higher among participants randomized to complete measures in Spanish. A sample of 722 Hispanic students from a Hispanic-serving university participated in the study. Participants were first asked to complete translation tasks to verify that they were fully bilingual. Based on ratings from two independent coders, 574 participants (79.5% of the sample) qualified as fully bilingual and were randomized to complete the acculturation measures in either English or Spanish. Theoretically relevant criterion measures – self-esteem, depressive symptoms, and personal identity – were also administered in the randomized language. Measurement equivalence analyses indicated that all of the acculturation measures – Hispanic and U.S. practices, values, and identifications – met criteria for configural, weak/metric, strong/scalar, and convergent validity equivalence. These findings indicate that data generated using acculturation measures can, at least under some conditions, be combined or compared across languages of administration. Few latent mean differences emerged. These results are discussed in terms of the measurement of acculturation in linguistically diverse populations. PMID:24188146

A Meta-Intervention to Increase Completion of an HIV-Prevention Intervention: Results from a Randomized Controlled Trial in the State of Florida

PubMed Central

Albarracín, Dolores; Wilson, Kristina; Durantini, Marta R.; Sunderrajan, Aashna; Livingood, William

2016-01-01

Objective A randomized control trial with 722 eligible clients from a health department in the State of Florida was conducted to identify a simple, effective meta-intervention to increase completion of an HIV-prevention counseling program. Method The overall design involved two factors representing an empowering and instrumental message, as well as an additional factor indicating presence or absence of expectations about the counseling. Completion of the three-session counseling was determined by recording attendance. Results A logistic regression analysis with the three factors of empowering message, instrumental message, and presence of mediator measures, as well as all interactions, revealed significant interactions between instrumental and empowering messages and between instrumental messages and presence of mediator measures. Results indicated that (a) the instrumental message alone produced most completion than any other message, and (b) when mediators were not measured, including the instrumental message led to greater completion. Conclusions The overall gains in completion as a result of the instrumental message were 16%, implying success in the intended facilitation of counseling completion. The measures of mediators did not detect any experimental effects, probably because the effects were happening without much conscious awareness. PMID:27786499

Estimating temporary emigration and breeding proportions using capture-recapture data with Pollock's robust design

USGS Publications Warehouse

Kendall, W.L.; Nichols, J.D.; Hines, J.E.

1997-01-01

Statistical inference for capture-recapture studies of open animal populations typically relies on the assumption that all emigration from the studied population is permanent. However, there are many instances in which this assumption is unlikely to be met. We define two general models for the process of temporary emigration, completely random and Markovian. We then consider effects of these two types of temporary emigration on Jolly-Seber (Seber 1982) estimators and on estimators arising from the full-likelihood approach of Kendall et al. (1995) to robust design data. Capture-recapture data arising from Pollock's (1982) robust design provide the basis for obtaining unbiased estimates of demographic parameters in the presence of temporary emigration and for estimating the probability of temporary emigration. We present a likelihood-based approach to dealing with temporary emigration that permits estimation under different models of temporary emigration and yields tests for completely random and Markovian emigration. In addition, we use the relationship between capture probability estimates based on closed and open models under completely random temporary emigration to derive three ad hoc estimators for the probability of temporary emigration, two of which should be especially useful in situations where capture probabilities are heterogeneous among individual animals. Ad hoc and full-likelihood estimators are illustrated for small mammal capture-recapture data sets. We believe that these models and estimators will be useful for testing hypotheses about the process of temporary emigration, for estimating demographic parameters in the presence of temporary emigration, and for estimating probabilities of temporary emigration. These latter estimates are frequently of ecological interest as indicators of animal movement and, in some sampling situations, as direct estimates of breeding probabilities and proportions.

Effect of seeding rate on organic production

USDA-ARS?s Scientific Manuscript database

Increased demand for organic rice (Oryza sativa L.) has incentivized producer conversion from conventional to organically-managed rice production in the U.S. Little is known on the impacts of seeding rate on organic rice production. A completely randomized factorial design with four replications was...

The effects of teachers' homework follow-up practices on students' EFL performance: a randomized-group design

PubMed Central

Rosário, Pedro; Núñez, José C.; Vallejo, Guillermo; Cunha, Jennifer; Nunes, Tânia; Suárez, Natalia; Fuentes, Sonia; Moreira, Tânia

2015-01-01

This study analyzed the effects of five types of homework follow-up practices (i.e., checking homework completion; answering questions about homework; checking homework orally; checking homework on the board; and collecting and grading homework) used in class by 26 teachers of English as a Foreign Language (EFL) using a randomized-group design. Once a week, for 6 weeks, the EFL teachers used a particular type of homework follow-up practice they had previously been assigned to. At the end of the 6 weeks students completed an EFL exam as an outcome measure. The results showed that three types of homework follow-up practices (i.e., checking homework orally; checking homework on the board; and collecting and grading homework) had a positive impact on students' performance, thus highlighting the role of EFL teachers in the homework process. The effect of EFL teachers' homework follow-up practices on students' performance was affected by students' prior knowledge, but not by the number of homework follow-up sessions. PMID:26528204

The effects of teachers' homework follow-up practices on students' EFL performance: a randomized-group design.

PubMed

Rosário, Pedro; Núñez, José C; Vallejo, Guillermo; Cunha, Jennifer; Nunes, Tânia; Suárez, Natalia; Fuentes, Sonia; Moreira, Tânia

2015-01-01

This study analyzed the effects of five types of homework follow-up practices (i.e., checking homework completion; answering questions about homework; checking homework orally; checking homework on the board; and collecting and grading homework) used in class by 26 teachers of English as a Foreign Language (EFL) using a randomized-group design. Once a week, for 6 weeks, the EFL teachers used a particular type of homework follow-up practice they had previously been assigned to. At the end of the 6 weeks students completed an EFL exam as an outcome measure. The results showed that three types of homework follow-up practices (i.e., checking homework orally; checking homework on the board; and collecting and grading homework) had a positive impact on students' performance, thus highlighting the role of EFL teachers in the homework process. The effect of EFL teachers' homework follow-up practices on students' performance was affected by students' prior knowledge, but not by the number of homework follow-up sessions.

Design challenges in transdiagnostic psychotherapy research: Comparing Transdiagnostic Behavior Therapy (TBT) to existing evidence-based psychotherapy in veterans with affective disorders.

PubMed

Gros, Daniel F

2015-07-01

To address the limitations of disorder-specific approaches, newer transdiagnostic approaches to psychotherapy have been developed to provide a single treatment that is capable of addressing several, related disorders. However, the recruitment of multiple diagnoses presents many challenges to the traditional design of psychotherapy randomized controlled trials (RCTs). The goal of the manuscript is to present the challenges and rationale for designing a RCT for transdiagnostic treatment to inform and aid in the development of future investigations. A recently funded and ongoing RCT for Transdiagnostic Behavior Therapy (TBT) is used as an example to discuss the related design challenges. The TBT study involves the recruitment of 96 veteran participants with any of the following eight principal diagnoses: posttraumatic stress disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, generalized anxiety disorder, specific phobia, major depressive disorder, or persistent depressive disorder. Within the TBT study, participants will complete a semi-structured diagnostic interview and a series of transdiagnostic self-report measures to determine eligibility and assess baseline symptomatology. Qualifying participants will be randomized to TBT or control psychotherapy. Additional assessments will be completed at post-treatment and 6-month follow-up. Due to the transdiagnostic nature of the sample, adjustments to the recruitment and randomization procedures, selection of measures, selection of control psychotherapy, and analysis plan were required. These adjustments have implications to future trials on transdiagnostic psychotherapy protocols as well as future research in line with the transdiagnostic focus of the National Institute of Mental Health's Research Domain Criteria (RDoC) funding strategy. Published by Elsevier Inc.

Acceptability of randomization to levonorgestrel versus copper intrauterine device among women requesting IUD insertion for contraception

PubMed Central

Achilles, Sharon L.; Chen, Beatrice A.; Lee, Jessica K.; Gariepy, Aileen M.; Creinin, Mitchell D.

2015-01-01

Objective Assess feasibility of randomizing women to intrauterine device (IUD) type. Study Design Women enrolling in a 2-month study who desired an IUD for contraception were randomized 1:1 to receive a levonorgestrel 52mg IUD (LNG-IUD) or copper T380A (Cu-IUD), understanding they could switch IUD type at the end of the study. Results Randomization to IUD type was acceptable to 54/55 (98%) women who screened. All 32 enrolled participants completed follow-up. Two women exchanged their IUD (Cu-IUD to LNG-IUD) and 2 requested removal (1 LNG-IUD, 1 Cu-IUD). Overall, 88% continued their assigned IUD. Conclusions Randomization to IUD type is feasible and few women change their IUD. PMID:26297203

Nonfumigant Alternatives to Methyl Bromide for Production of Snapdragon (Antirrhinum majus)

USDA-ARS?s Scientific Manuscript database

Two field experiments were conducted in north Florida to examine effects of solarization and reduced-risk pesticides on weeds, nematodes, soil-borne diseases, and yield of snapdragon (Antirrhinum majus). Five treatments were replicated five times in a randomized complete block design: fumigation wit...

Maronutrient distribution in 'Tifblue' rabbiteye blueberry

USDA-ARS?s Scientific Manuscript database

This study was developed and initiated to determine the nutrient distribution within a ‘Tifblue’ rabbiteye blueberry. Rooted cuttings were potted into 3.8 liter containers and placed into a completely randomized design on a covered bench. Plants were divided evenly into 3 groups for low, high a...

Rhizoctonia crown and root rot disease nursery

USDA-ARS?s Scientific Manuscript database

The BSDF cooperative CRR Eastern Evaluation Nursery Rhizoctonia crown and root rot Evaluation Nursery in 2016 was a randomized complete-block design with five replications in 15 feet long, one-row plots (20 in row spacing), at the Saginaw Valley Research and Education Center near Frankenmuth, MI. F...

EVALUATION OF BIOREMEDIATION STRATEGIES OF A CONTROLLED OIL RELEASE IN A WETLAND

EPA Science Inventory

A controlled petroleum release was conducted to evaluate bioremediation in a wetland near Houston, Texas. The 140-day study was conducted using a randomized, complete block design to test three treatments with six replicates per treatment. The three treatment strategies were in...

[Design of the National Surveillance of Nutritional Indicators (MONIN), Peru 2007-2010].

PubMed

Campos-Sánchez, Miguel; Ricaldi-Sueldo, Rita; Miranda-Cuadros, Marianella

2011-06-01

To describe the design and methods of the national surveillance of nutritional indicators (MONIN) 2007-2010, carried out by INS/CENAN. MONIN was designed as a continuous (repeated cross-sectional) survey, with stratified multi-stage random sampling, considering the universe as all under five children and pregnant women residing in Peru, divided into 5 geographical strata and 6 trimesters (randomly permuted weeks, about 78% of the time between November 19, 2007 and April 2, 2010). The total sample was 3,827 children in 361 completed clusters. The dropout rate was 8.4% in clusters, 1.8% in houses, and 13.2% in households. Dropout was also 4.2, 13.3, 21.2, 55% and 29% in anthropometry, hemoglobin, food intake, retinol and ioduria measurements, respectively. The MONIN design is feasible and useful for the estimation of indicators of childhood malnutrition.

Osteoporosis therapies: evidence from health-care databases and observational population studies.

PubMed

Silverman, Stuart L

2010-11-01

Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

On random field Completely Automated Public Turing Test to Tell Computers and Humans Apart generation.

PubMed

Kouritzin, Michael A; Newton, Fraser; Wu, Biao

2013-04-01

Herein, we propose generating CAPTCHAs through random field simulation and give a novel, effective and efficient algorithm to do so. Indeed, we demonstrate that sufficient information about word tests for easy human recognition is contained in the site marginal probabilities and the site-to-nearby-site covariances and that these quantities can be embedded directly into certain conditional probabilities, designed for effective simulation. The CAPTCHAs are then partial random realizations of the random CAPTCHA word. We start with an initial random field (e.g., randomly scattered letter pieces) and use Gibbs resampling to re-simulate portions of the field repeatedly using these conditional probabilities until the word becomes human-readable. The residual randomness from the initial random field together with the random implementation of the CAPTCHA word provide significant resistance to attack. This results in a CAPTCHA, which is unrecognizable to modern optical character recognition but is recognized about 95% of the time in a human readability study.

Nitrogen fertilization effects on sorghum forage yield and quality

USDA-ARS?s Scientific Manuscript database

The study objective was to determine the effect of nitrogen fertilization on yield and quality of photoperiod sensitive (PS) and non-PS forage sorghum, sorghum-sudangrass, and sudangrass compared to corn. This study was a randomized complete block design with treatments arranged in a 4 x 8 factorial...

Destiny-yield relationship for channel catfish reared in a biofloc technology production system

USDA-ARS?s Scientific Manuscript database

The effect of stocking density on yield of stocker channel catfish and water quality in a biofloc technology production system was studied in this completely randomized design experiment. Fingerling channel catfish (Ictalurus punctatus; 48.0 g/fish, 17.8 cm/fish) were stocked into nine continuously ...

Influence of aluminum on growth, mineral nutrition and organic acid exudation of rambutan (Nephelium lappaceum)

USDA-ARS?s Scientific Manuscript database

A randomized complete block design experiment with six aluminum (Al) concentrations was carried out to evaluate the effect of aluminum on nutrient content, plant growth, dry matter production and Al-induced organic acid exudation in rambutan (Nephelium lappaceum). One rambutan cultivar was grown in...

An Analysis of Factors Contributing to Achievement in Physics of Secondary Students in Mississippi Schools.

ERIC Educational Resources Information Center

Harpole, Sandra H.; And Others

Designed to examine the factors that contribute to student achievement, this study focused specifically on the relationship between physics achievement and selected teacher characteristics, student characteristics, and school and district characteristics. Questionnaires and attitude surveys were completed by 39 randomly selected Mississippi…

CACAO (THEOBROMA CACAO L.) GENETIC RESOURCES RESEARCH AT THE USDA-ARS TROPICAL AGRICULTURE RESEARCH STATION

USDA-ARS?s Scientific Manuscript database

The current USDA ARS Tropical Agriculture Research Station’s cacao (Theobroma cacao) collection consists of 154 clonally propagated accessions. Each accession is represented by six individual trees grafted on Amelonado rootstocks and planted in a completely randomized block design with three blocks...

EXTENT, PROPERTIES, AND LANDSCAPE SETTING OF GEOGRAPHICALLY ISOLATED WETLANDS IN URBAN SOUTHERN NEW ENGLAND WATERSHEDS

EPA Science Inventory

We assessed the extent and characteristics of geographically isolated wetlands (i.e., wetlands completely surrounded by upland) in a series of drainage basins in the urban northeast U.S. We employed a random sampling design that stratifies study sites according to their degree o...

INVESTIGATION OF ORGANIC WEED CONTROL METHODS, PESTICIDE SPECIAL STUDY, COLORADO STATE UNIVERSITY

EPA Science Inventory

The project is proposed for the 2003 and 2004 growing seasons. Corn gluten meal (CGM), treated paper mulch and plastic mulch, along with conventional herbicide, will be applied to fields of drip irrigated broccoli in a randomized complete block design with 6 replicates. Due to ...

Shade, irrigation, and nutrients affect flavanoid concentration and yield in American Skullcap.

USDA-ARS?s Scientific Manuscript database

American skullcap (Scutellaria lateriflora L.) is valued for its sedative properties that are associated with flavonoids. Information on how growing conditions affect flavonoid content is lacking. A 2x2x3 factorial experiment was conducted in a randomized complete block design (r = 4) with a split ...

Mastery, Maladaptive Learning Behaviour, and Academic Achievement: An Intervention Approach

ERIC Educational Resources Information Center

Ranellucci, John; Hall, Nathan; Muis, Krista; Lajoie, Susanne; Robinson, Kristy

2017-01-01

The effects of three interventions designed to boost academic achievement among mastery-oriented students were evaluated on interest-based studying, social desirability, and perceived goal difficulty. Undergraduate students (N = 177) completed relevant self-report measures at the beginning and the end of the semester and were randomly assigned to…

The effects of Lactobacillus Acidophilus fermentation products as an alternative to antibiotics

USDA-ARS?s Scientific Manuscript database

This experiment compared the effects of Lactobacillus acidophilus fermentation products (LAFP) to carbadox and copper sulfate on growth performance and complete blood counts (CBC). Eight hundred pigs were weaned at 24 d of age and utilized in a randomized block design (4 farrowing groups, blocked by...

The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

ERIC Educational Resources Information Center

Bainbridge, Lauren A.; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong; Ingham, Roger J.

2015-01-01

Purpose: Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method: Four groups, each with 12 randomly allocated participants, completed a pretest-posttest design training study. They were evaluated by their counts of…

Selecting the best design for nonstandard toxicology experiments.

PubMed

Webb, Jennifer M; Smucker, Byran J; Bailer, A John

2014-10-01

Although many experiments in environmental toxicology use standard statistical experimental designs, there are situations that arise where no such standard design is natural or applicable because of logistical constraints. For example, the layout of a laboratory may suggest that each shelf serve as a block, with the number of experimental units per shelf either greater than or less than the number of treatments in a way that precludes the use of a typical block design. In such cases, an effective and powerful alternative is to employ optimal experimental design principles, a strategy that produces designs with precise statistical estimates. Here, a D-optimal design was generated for an experiment in environmental toxicology that has 2 factors, 16 treatments, and constraints similar to those described above. After initial consideration of a randomized complete block design and an intuitive cyclic design, it was decided to compare a D-optimal design and a slightly more complicated version of the cyclic design. Simulations were conducted generating random responses under a variety of scenarios that reflect conditions motivated by a similar toxicology study, and the designs were evaluated via D-efficiency as well as by a power analysis. The cyclic design performed well compared to the D-optimal design. © 2014 SETAC.

MSC/NASTRAN Stress Analysis of Complete Models Subjected to Random and Quasi-Static Loads

NASA Technical Reports Server (NTRS)

Hampton, Roy W.

2000-01-01

Space payloads, such as those which fly on the Space Shuttle in Spacelab, are designed to withstand dynamic loads which consist of combined acoustic random loads and quasi-static acceleration loads. Methods for computing the payload stresses due to these loads are well known and appear in texts and NASA documents, but typically involve approximations such as the Miles' equation, as well as possible adjustments based on "modal participation factors." Alternatively, an existing capability in MSC/NASTRAN may be used to output exact root mean square [rms] stresses due to the random loads for any specified elements in the Finite Element Model. However, it is time consuming to use this methodology to obtain the rms stresses for the complete structural model and then combine them with the quasi-static loading induced stresses. Special processing was developed as described here to perform the stress analysis of all elements in the model using existing MSC/NASTRAN and MSC/PATRAN and UNIX utilities. Fail-safe and buckling analyses applications are also described.

A randomized trial of the impact of survey design characteristics on response rates among nursing home providers.

PubMed

Clark, Melissa; Rogers, Michelle; Foster, Andrew; Dvorchak, Faye; Saadeh, Frances; Weaver, Jessica; Mor, Vincent

2011-12-01

An experiment was conducted to maximize participation of both the Director of Nursing (DoN) and the Administrator (ADMIN) in long-term care facilities. Providers in each of the 224 randomly selected facilities were randomly assigned to 1 of 16 conditions based on the combination of data collection mode (web vs. mail), questionnaire length (short vs. long), and incentive structure. Incentive structures were determined by amount compensated if the individual completed and an additional amount per individual if the pair completed (a) $30 individual/$5 pair/$35 total; (b) $10 individual/$25 pair/$35 total; (c) $30 individual/$20 pair/$50 total; and (d) $10 individual/$40 pair/$50 total. Overall, 47.4% of eligible respondents participated; both respondents participated in 29.3% of facilities. In multivariable analyses, there were no differences in the likelihood of both respondents participating by mode, questionnaire length, or incentive structure. Providing incentives contingent on participation by both providers of a facility was an ineffective strategy for significantly increasing response rates.

Bacteriological evaluation for one-and two-piece implant design supporting mandibular overdenture

PubMed Central

Abdelwahed, Ahmed; Mahrous, Ahmed I.; Abadallah, Mohamed Farouk; Asfour, Hani; Aldawash, Hussien A.; Alagha, Ebaa I.

2015-01-01

Background: This study evaluated and compared the bacteriological effect of two-piece implants and one-piece implants in complete overdenture cases on supporting structures. Materials and Methods: Ten male completely edentulous patients were selected and randomly divided into two equal groups according to the implant design and surgical technique for this study; Group 1: Patients were rehabilitated with complete mandibular overdenture supported by two-piece implants one on each side of the lower arch following two-stage surgical technique and Group 2: Patients were rehabilitated with complete mandibular overdenture supported by one-piece implants one on each side. Evaluation was made at the time of insertion, 6, 12, and 18 months after overdenture insertion, by measuring bacteriological changes around implants abutments. Results: Complete overdenture supported by one-piece implants showed better effect on the bacteriological changes as compared to that supported by two-piece implants. Conclusion: Complete overdenture supported by one-piece implants one on each side of the lower arch showed better effect on the bacteriological changes than using the same prosthesis supported by two-piece implants. PMID:26903697

Design and rationale of the assessment of proper physiologic response with rate adaptive pacing driven by minute ventilation or accelerometer (APPROPRIATE) trial.

PubMed

Gilliam, F Roosevelt; Giudici, Michael; Benn, Andrew; Koplan, Bruce; Berg, Kellie Jean Chase; Kraus, Stacia Merkel; Stolen, Kira Q; Alvarez, Guy E; Hopper, Donald L; Wilkoff, Bruce L

2011-02-01

Rate-adaptive sensors are designed to restore a physiologic heart rate response to activity, in particular for patients that have chronotropic incompetence (CI). Limited data exist comparing two primary types of sensors; an accelerometer (XL) sensor which detects activity or motion and a minute ventilation (MV) sensor, which detects the product of respiration rate and tidal volume. The APPROPRIATE study will evaluate the MV sensor compared with the XL sensor for superiority in improving functional capacity (peak VO(2)) in pacemaker patients that have CI. This study is a double-blind, randomized, two-arm trial that will enroll approximately 1,000 pacemaker patients. Patients will complete a 6-min walk test at the 2-week visit to screen for potential CI. Those projected to have CI will advance to a 1-month visit. At the 1-month visit, final determination of CI will be done by completing a peak exercise treadmill test while the pacemaker is programmed to DDDR with the device sensors set to passive. Patients failing to meet the study criteria for CI will not continue further in the trial. Patients that demonstrate CI will be randomized to program their rate-adaptive sensors to either MV or XL in a 1:1 ratio. The rate-adaptive sensor will be optimized for each patient using a short walk to determine the appropriate response factor. At a 2-month visit, patients will complete a CPX test with the rate-adaptive sensors in their randomized setting.

Enhancing motivation with the "virtual" supervisory role: a randomized trial.

PubMed

Wingo, Majken T; Thomas, Kris G; Thompson, Warren G; Cook, David A

2015-04-14

We aimed to explore the influence of a motivationally-enhanced instructional design on motivation to learn and knowledge, hypothesizing that outcomes would be higher for the enhanced instructional format. Medicine residents completed four online learning modules on primary care topics. Using a crossover design, learners were randomized to receive two standard and two motivationally-enhanced learning modules. Both formats had self-assessment questions, but the enhanced format questions were framed to place learners in a supervisory/teaching role. Learners received a baseline motivation questionnaire, a short motivation survey before and after each module, and a knowledge posttest. One hundred twenty seven residents were randomized. 123 residents (97%) completed at least one knowledge posttest and 119 (94%) completed all four posttests. Across all modules, a one-point increase in the pretest short motivation survey was associated with a 2.1-point increase in posttest knowledge. The change in motivation was significantly higher for the motivationally enhanced format (standard mean change -0.01, enhanced mean change +0.09, difference = 0.10, CI 0.001 to 0.19; p = 0.048). Mean posttest knowledge score was similar (standard mean 72.8, enhanced mean 73.0, difference = 0.2, CI -1.9 to 2.1; p = 0.90). The motivationally enhanced instructional format improved motivation more than the standard format, but impact on knowledge scores was small and not statistically significant. Learners with higher pre-intervention motivation scored better on post-intervention knowledge tests, suggesting that motivation may prove a viable target for future instructional enhancements.

A Randomized Phase II Dose-Response Exercise Trial among Colon Cancer Survivors: Purpose, Study Design, Methods, and Recruitment Results

PubMed Central

Brown, Justin C.; Troxel, Andrea B.; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S.; Rickels, Michael R.; Rhim, Andrew D.; Rustgi, Anil K.; Courneya, Kerry S.; Schmitz, Kathryn H.

2016-01-01

Background Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the COURAGE trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. Methods/Results The primary objective of the COURAGE trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·wk−1) and high-dose (300 min·wk−1) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1,433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (P<0.001) and randomization onto the study protocol (P<0.001). No other demographic, clinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. Discussion The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. PMID:26970181

Influences of shelterwood prescriptions to aboveground carbon storage and herpetofaunal and small mammal communities

Treesearch

Padraic Conner; Yong Wang; Callie Jo Schweitzer

2015-01-01

We examined the response of herpetofaunal and small mammal communities to silvicultural treatments. In addition, differences between silvicultural treatments of carbon storage ratios in trees, shrubs, vines, herbaceous material, course woody debris, and fine woody debris were studied. A complete randomized design with multiple replications, 20 experimental stands of...

Sunn Hemp Biomass and Nitrogen Production for Different Planting Dates and Seeding Rates

USDA-ARS?s Scientific Manuscript database

Elevated nitrogen (N) fertilizer costs have renewed interest in alternative N sources, such as legumes. Sunn hemp (Crotalaria juncea L.) is a tropical legume capable of producing considerable biomass in a short period of time. A randomized complete block design with a split-plot restriction and fou...

Family Meals among New Zealand Young People: Relationships with Eating Behaviors and Body Mass Index

ERIC Educational Resources Information Center

Utter, Jennifer; Denny, Simon; Robinson, Elizabeth; Fleming, Terry; Ameratunga, Shanthi; Grant, Sue

2013-01-01

Objective: To examine the relationship between family meals and nutrition behaviors of adolescents. Design: Secondary analysis of Youth'07, a nationally representative survey. Setting: Secondary schools in New Zealand. Participants: Randomly selected adolescents (aged 13-17 years, n = 9,107) completed a multimedia and anonymous survey about their…

Knowledge, Attitudes and Behaviours. Concerning Education for Sustainable Development: Two Exploratory Studies

ERIC Educational Resources Information Center

Michalos, Alex C.; Creech, Heather; McDonald, Christina; Kahlke, P. Maurine Hatch

2011-01-01

Celebrating the UN Decade of Education for Sustainable Development (2005-2014), this paper presents results of two exploratory surveys taken in the province of Manitoba, Canada in January to March 2008. A random sample of 506 adults completed a mailed out questionnaire designed to measure respondents' knowledge, attitudes and behaviours concerning…

Supplemental dietary L-arginine attenuates intestinal mucosal disruption during a coccidial vaccine challenge in broiler chickens

USDA-ARS?s Scientific Manuscript database

The present study investigated the effects of dietary arginine (Arg) supplementation on intestinal barrier integrity in broiler chickens undergoing coccidial challenge. The design of this study was a randomized complete block employing a 3 x 2 factorial arrangement (n = 8) with 3 level of Arg (1.11,...

NAA thinning of ‘W. Murcott’

USDA-ARS?s Scientific Manuscript database

This study was conducted to determine if NAA thinning may be useful for managing cropload in Florida ‘W Murcott’. Trials were conducted in two groves of ages 4 and 6 years. NAA was applied on 13 May, 2010, when fruitlets averaged 10-12 mm in diameter. A randomized complete block design was used, ...

Effect of selenium treatment on biomass production and mineral content in common bean varieties

USDA-ARS?s Scientific Manuscript database

The mineral selenium is important to human health. The goal of the research was to evaluate common bean cultivars for their responses to and abilities to accumulate selenium. The experimental design was completely randomized and the treatments consisted of control (in modified Hoagland and Arnon's s...

Evaluation of fungicide rotations for management of Phytophthora fruit rot of watermelon, 2015

USDA-ARS?s Scientific Manuscript database

The experiment was conducted at the U.S. Vegetable Laboratory farm in Charleston, SC. The soil was Yonges loamy fine sand. For the past 6 years, the field has been infested with Phytophthora capsici. The experimental design was a randomized complete block with four replications. Five-week-old seedli...

Performance of finishing beef steers in response to anabolic implant dose and zilpaterol hydrochloride

USDA-ARS?s Scientific Manuscript database

British × Continental steers (n = 168; 7 pens/treatment; initial BW = 362 kg) were used to evaluate the dose of trenbolone acetate (TBA) and estradiol-17ß (E2) and feeding of zilpaterol hydrochloride (ZH) on performance and carcass characteristics. A randomized complete block design was used with a ...

Performance of finishing beef steers in response to anabolic implant and zilpaterol hydrochloride supplementation

USDA-ARS?s Scientific Manuscript database

Our objectives were to evaluate the dose/payout pattern of trenbolone acetate (TBA) and estradiol-17b (E2) implants and feeding of zilpaterol hydrochloride (ZH) on performance and carcass characteristics of finishing beef steers. A randomized complete block design was used with a 3 × 2 factorial arr...

Biodiversity and fire in shortgrass steppe

Treesearch

P. L. (Paulette) Ford

2001-01-01

Effects of fire at two levels of intensity on beetle diversity in shortgrass steppe were examined. The experimental design was completely randomized, with 3 treatments and 4 replicates per treatment. Treatments were two levels of fire 1) dormant-season fire (relatively hot), and 2) growing-season fire (relatively cool), and unburned plots. The response variables were...

Chromium supplementation alters the performance, metabolism, and immune response of feedlot cattle during the receiving period

USDA-ARS?s Scientific Manuscript database

Crossbreed steers (n = 180; 507 +/- 13 lb) were fed during a 56-d receiving period to determine if supplementing chromium (Cr; KemTRACEbrandChromiumPropionate 0.04%, Kemin Industries) would improve feedlot performance and health of newly received cattle. A completely randomized block design (36 pens...

Understory response to fuel reduction treatments in the Blue Mountains of northeastern Oregon.

Treesearch

Kerry L. Metlen; Carl E. Fiedler; Andrew. Youngblood

2004-01-01

Understory response to fuel reduction treatments was evaluated in fire-adapted ponderosa pine-Douglas-fir forests in northeastern Oregon. Treatments included: no management (control), prescribed fall burning (burn), low thinning (thin), and low thinning followed by prescribed fall burning (thin/burn), replicated four times in a completely randomized design. Treatment...

Effect of Starch Sources and Protein Content on Extruded Aquaculture Feed Containing DDGS

USDA-ARS?s Scientific Manuscript database

A 3x3 completely randomized design was used to investigate the extrusion cooking and product characteristics of DDGS, protein levels, and various starch sources in a laboratory scale single screw extruder. Cassava, corn, and potato starches with varying levels of DDGS (20, 30, and 40% wb) were extru...

Evaluation of a Brief Intervention Designed to Increase CPR Training among Pregnant Pool Owners

ERIC Educational Resources Information Center

Girasek, Deborah C.

2011-01-01

This study evaluated whether a brief videotape could motivate pregnant pool owners to be trained in infant/child cardiopulmonary resuscitation (CPR). Women were recruited from prenatal classes in South Florida. Eligible volunteers were randomized to view a video or receive standard treatment, after completing a questionnaire. The video explained…

Loblolly Pine Growth 16 Years After Four Site Preparation Treatments

Treesearch

John C. Adams; Clyde Vidrine

2002-01-01

Thirteen-year growth results of 1-0 planted loblolly pine seedlings (Pinus taeda L.) on differently prepared upland mixed pine-hardwood sites located in north western Louisiana are presented. The study was designed as a randomized complete block consisting of three blocks of four site preparation treatments, which included: chop and burn, windrow,...

Evaluation of Residential Consumers Knowledge of Wireless Network Security and Its Correlation with Identity Theft

ERIC Educational Resources Information Center

Kpaduwa, Fidelis Iheanyi

2010-01-01

This current quantitative correlational research study evaluated the residential consumers' knowledge of wireless network security and its relationship with identity theft. Data analysis was based on a sample of 254 randomly selected students. All the study participants completed a survey questionnaire designed to measure their knowledge of…

Multiple rolling/crimping effects on termination of two summer cover crops in a conservation system

USDA-ARS?s Scientific Manuscript database

A field experiment was initiated in the 2015 growing season at the USDA-NSDL to determine the effectiveness of a prototype two-stage roller/crimper in mechanical termination of two summer cover crops intended for organic systems. The experiment was a randomized complete block design with four replic...

Ergonomics intervention in an Iranian television manufacturing industry.

PubMed

Motamedzade, M; Mohseni, M; Golmohammadi, R; Mahjoob, H

2011-01-01

The primary goal of this study was to use the Strain Index (SI) to assess the risk of developing upper extremity musculoskeletal disorders in a television (TV) manufacturing industry and evaluate the effectiveness of an educational intervention. The project was designed and implemented in two stages. In first stage, the SI score was calculated and the Nordic Musculoskeletal Questionnaire (NMQ) was completed. Following this, hazardous jobs were identified and existing risk factors in these jobs were studied. Based on these data, an educational intervention was designed and implemented. In the second stage, three months after implementing the interventions, the SI score was re-calculated and the Nordic Musculoskeletal Questionnaire (NMQ) completed again. 80 assembly workers of an Iranian TV manufacturing industry were randomly selected using simple random sampling approach. The results showed that the SI score had a good correlation with the symptoms of musculoskeletal disorders. It was also observed that the difference between prevalence of signs and symptoms of musculoskeletal disorders, before and after intervention, was significantly reduced. A well conducted implementation of an interventional program with total participation of all stakeholders can lead to a decrease in musculoskeletal disorders.

Improving recruitment and retention for an online randomized controlled trial: experience from the Youthnet study.

PubMed

Bull, S S; Vallejos, D; Levine, D; Ortiz, C

2008-09-01

The objective of the study was to present recruitment and retention findings for an Internet based HIV prevention trial evaluated using a randomized controlled design among 15-25-year-olds accessing a website on the Internet. We used a combination of automated electronic and personalized approaches to increase and diversify recruitment, verify participant eligibility and increase retention. We posted 3.5 million banner advertisements, 9354 individuals clicked on the advertisement, 8950 completed an eligibility screener and 3298 a baseline survey; we flagged 675 of these as suspicious and enrolled 2623 individuals. Of these, 2082 (79%) completed a follow-up at one-month and 1398 (53%) completed a two-month follow-up. This retention rate is the highest we have seen for an Internet-based HIV-prevention trial. Our procedures can be replicated in other trials. We stress the importance of using a combination of automated and personalized techniques to increase enrollment, verify eligibility and promote retention.

A phase 2 autologous cellular therapy trial in patients with acute, complete spinal cord injury: pragmatics, recruitment, and demographics.

PubMed

Jones, L A T; Lammertse, D P; Charlifue, S B; Kirshblum, S C; Apple, D F; Ragnarsson, K T; Poonian, D; Betz, R R; Knoller, N; Heary, R F; Choudhri, T F; Jenkins, A L; Falci, S P; Snyder, D A

2010-11-01

Post hoc analysis from a randomized controlled cellular therapy trial in acute, complete spinal cord injury (SCI). Description and quantitative review of study logistics, referral patterns, current practice patterns and subject demographics. Subjects were recruited to one of six international study centers. Data are presented from 1816 patients pre-screened, 75 participants screened and 50 randomized. Of the 1816 patients pre-screened, 53.7% did not meet initial study criteria, primarily due to an injury outside the time window (14 days) or failure to meet neurological criteria (complete SCI between C5 motor/C4 sensory and T11). MRIs were obtained on 339 patients; 51.0% were ineligible based on imaging criteria. Of the 75 participants enrolled, 25 failed screening (SF), leaving 50 randomized. The primary reason for SF was based on the neurological exam (51.9%), followed by failure to meet MRI criteria (22.2%). Of the 50 randomized subjects, there were no significant differences in demographics in the active versus control arms. In those participants for whom data was available, 93.8% (45 of 48) of randomized participants received steroids before study entry, whereas 94.0% (47 of 50) had spine surgery before study enrollment. The 'funnel effect' (large numbers of potentially eligible participants with a small number enrolled) impacts all trials, but was particularly challenging in this trial due to eligibility criteria and logistics. Data collected may provide information on current practice patterns and the issues encountered and addressed may facilitate design of future trials.

Probabilistic DHP adaptive critic for nonlinear stochastic control systems.

PubMed

Herzallah, Randa

2013-06-01

Following the recently developed algorithms for fully probabilistic control design for general dynamic stochastic systems (Herzallah & Káarnáy, 2011; Kárný, 1996), this paper presents the solution to the probabilistic dual heuristic programming (DHP) adaptive critic method (Herzallah & Káarnáy, 2011) and randomized control algorithm for stochastic nonlinear dynamical systems. The purpose of the randomized control input design is to make the joint probability density function of the closed loop system as close as possible to a predetermined ideal joint probability density function. This paper completes the previous work (Herzallah & Káarnáy, 2011; Kárný, 1996) by formulating and solving the fully probabilistic control design problem on the more general case of nonlinear stochastic discrete time systems. A simulated example is used to demonstrate the use of the algorithm and encouraging results have been obtained. Copyright © 2013 Elsevier Ltd. All rights reserved.

The effect of implementing cognitive load theory-based design principles in virtual reality simulation training of surgical skills: a randomized controlled trial.

PubMed

Andersen, Steven Arild Wuyts; Mikkelsen, Peter Trier; Konge, Lars; Cayé-Thomasen, Per; Sørensen, Mads Sølvsten

2016-01-01

Cognitive overload can inhibit learning, and cognitive load theory-based instructional design principles can be used to optimize learning situations. This study aims to investigate the effect of implementing cognitive load theory-based design principles in virtual reality simulation training of mastoidectomy. Eighteen novice medical students received 1 h of self-directed virtual reality simulation training of the mastoidectomy procedure randomized for standard instructions (control) or cognitive load theory-based instructions with a worked example followed by a problem completion exercise (intervention). Participants then completed two post-training virtual procedures for assessment and comparison. Cognitive load during the post-training procedures was estimated by reaction time testing on an integrated secondary task. Final-product analysis by two blinded expert raters was used to assess the virtual mastoidectomy performances. Participants in the intervention group had a significantly increased cognitive load during the post-training procedures compared with the control group (52 vs. 41 %, p  = 0.02). This was also reflected in the final-product performance: the intervention group had a significantly lower final-product score than the control group (13.0 vs. 15.4, p  < 0.005). Initial instruction using worked examples followed by a problem completion exercise did not reduce the cognitive load or improve the performance of the following procedures in novices. Increased cognitive load when part tasks needed to be integrated in the post-training procedures could be a possible explanation for this. Other instructional designs and methods are needed to lower the cognitive load and improve the performance in virtual reality surgical simulation training of novices.

Confidence intervals for single-case effect size measures based on randomization test inversion.

PubMed

Michiels, Bart; Heyvaert, Mieke; Meulders, Ann; Onghena, Patrick

2017-02-01

In the current paper, we present a method to construct nonparametric confidence intervals (CIs) for single-case effect size measures in the context of various single-case designs. We use the relationship between a two-sided statistical hypothesis test at significance level α and a 100 (1 - α) % two-sided CI to construct CIs for any effect size measure θ that contain all point null hypothesis θ values that cannot be rejected by the hypothesis test at significance level α. This method of hypothesis test inversion (HTI) can be employed using a randomization test as the statistical hypothesis test in order to construct a nonparametric CI for θ. We will refer to this procedure as randomization test inversion (RTI). We illustrate RTI in a situation in which θ is the unstandardized and the standardized difference in means between two treatments in a completely randomized single-case design. Additionally, we demonstrate how RTI can be extended to other types of single-case designs. Finally, we discuss a few challenges for RTI as well as possibilities when using the method with other effect size measures, such as rank-based nonoverlap indices. Supplementary to this paper, we provide easy-to-use R code, which allows the user to construct nonparametric CIs according to the proposed method.

Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.

PubMed

Roboz, Gail J; Montesinos, Pau; Selleslag, Dominik; Wei, Andrew; Jang, Jun-Ho; Falantes, Jose; Voso, Maria T; Sayar, Hamid; Porkka, Kimmo; Marlton, Paula; Almeida, Antonio; Mohan, Sanjay; Ravandi, Farhad; Garcia-Manero, Guillermo; Skikne, Barry; Kantarjian, Hagop

2016-02-01

Older patients with acute myeloid leukemia (AML) have worse rates of complete remission and shorter overall survival than younger patients. The epigenetic modifier CC-486 is an oral formulation of azacitidine with promising clinical activity in patients with AML in Phase I studies. The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged ≥55 years with AML in first complete remission. The primary end point is overall survival. Secondary end points include relapse-free survival, safety, health-related quality of life and healthcare resource utilization. This trial will investigate whether CC-486 maintenance can prolong remission and improve survival for older patients with AML.

The use of vignettes to empower effective responses to attempted sexual assault.

PubMed

Allen, Kaylie T; Meadows, Elizabeth A

2017-01-01

Women assertively resisting sexual aggression have the best chances of avoiding completed rape. Especially with acquaintances, there are significant social and psychological barriers to resistance. Novel vignettes depicting acquaintance rape were designed to enhance self-efficacy, reduce unrealistic optimism, and empower assertive resistance. The data were collected using a Web-based survey of 449 female college students from multiple universities in August-October 2014. Between-subjects mixed-methods design. Participants were randomly assigned to read one of four vignettes and complete self-report measures of personal vulnerability, self-efficacy, and beliefs and intention about resistance. Although vignettes did not impact self-efficacy, one vignette enhanced perceived controllability and decreased unrealistic optimism. Women who read about completed acquaintance rape described intention to use physically assertive responses at double the rate of women reading about successful resistance. As low-cost, easily disseminated materials, vignettes about sexual assault may enhance campus prevention efforts.

A randomized comparison between records made with an anesthesia information management system and by hand, and evaluation of the Hawthorne effect.

PubMed

Edwards, Kylie-Ellen; Hagen, Sander M; Hannam, Jacqueline; Kruger, Cornelis; Yu, Richard; Merry, Alan F

2013-10-01

Anesthesia information management system (AIMS) technology is designed to facilitate high-quality anesthetic recordkeeping. We examined the hypothesis that no difference exists between AIMS and handwritten anesthetic records in regard to the completeness of important information contained as text data. We also investigated the effect of observational research on the completeness of anesthesiologists' recordkeeping. As part of a larger randomized controlled trial, participants were randomized to produce 400 anesthetic records, either handwritten (n = 200) or using an AIMS (n = 200). Records were assessed against a 32-item checklist modified from a clinical guideline. Intravenous agent and bolus recordings were quantified, and data were compared between handwritten and AIMS records. Records produced with intensive research observation during the initial phase of the study (n = 200) were compared with records produced with reduced intensity observation during the final phase of the study (n = 200). The AIMS records were more complete than the handwritten records (mean difference 7.1%; 95% confidence interval [CI] 5.6 to 8.6%; P < 0.0001), with higher completion rates for six individual items on the checklist (P < 0.0001). Drug annotation data were equal between arms. The records completed early in the study, during a period of more intense observation, were more thorough than subsequent records (87.3% vs 81.6%, respectively; mean difference 5.7%; 95% CI 4.2 to 7.3%; P < 0.0001). The AIMS records were more complete than the handwritten records for 32 predefined items. The potential of observational research to influence professional behaviour in an anesthetic context was confirmed. This trial was registered at the Australian New Zealand Clinical Trials Registry No 12608000068369.

Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

PubMed

Hoberman, Alejandro; Shaikh, Nader; Bhatnagar, Sonika; Haralam, Mary Ann; Kearney, Diana H; Colborn, D Kathleen; Kienholz, Michelle L; Wang, Li; Bunker, Clareann H; Keren, Ron; Carpenter, Myra A; Greenfield, Saul P; Pohl, Hans G; Mathews, Ranjiv; Moxey-Mims, Marva; Chesney, Russell W

2013-06-01

A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND RELEVANCE Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision, and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty. Consideration of the factors included in the conceptual model should enhance the quality of the informed consent process and improve participation in pediatric clinical trials.

Growth performance and total tract nutrient digestion for Holstein heifers limit-fed diets high in distillers grains with different forage particle sizes

USDA-ARS?s Scientific Manuscript database

This study evaluated dairy heifer growth performance and total tract nutrient digestion when fed diets high in dried distillers grains with solubles (DDGS) with different forage particle size. An 8-wk randomized complete block design study was conducted utilizing twenty-two Holstein heifers (123 ±...

Forest-floor disturbance reduces chipmunk (Tamias spp.) abundance two years after variable-retention harvest of Pacific Northwestern forests

Treesearch

Randall J. Wilk; Timothy B. Harrington; Robert A. Gitzen; Chris C. Maguire

2015-01-01

We evaluated the two-year effects of variable-retention harvest on chipmunk (Tamias spp.) abundance (N^) and habitat in mature coniferous forests in western Oregon and Washington because wildlife responses to density/pattern of retained trees remain largely unknown. In a randomized complete-block design, six...

Evaluation of fungicide rotations and MELCAST for management of Phytophthora fruit rot of watermelon, 2014

USDA-ARS?s Scientific Manuscript database

The experiment was conducted at the U.S. Vegetable Laboratory farm in Charleston, SC. The soil was Yonges loamy fine sand, and for the past 5 years, the field has been infested with Phytophthora capsici. The experimental design was a randomized complete block with four replications. Four-week-old...

Effects of Higher and Lower Level Writing-To-Learn Assignments on Higher and Lower Level Examination Questions

ERIC Educational Resources Information Center

Nevid, Jeffrey S.; Ambrose, Michael A.; Pyun, Yea Seul

2017-01-01

Our study examined whether brief writing-to-learn assignments linked to lower and higher levels in Bloom's taxonomy affected performance differentially on examination performance in assessing these skill levels. Using a quasi-random design, 91 undergraduate students in an introductory psychology class completed eight lower level and eight higher…

Evaluating the Impact of a Brief Artistic Intervention on Cardiovascular Recovery from Acute Stress

ERIC Educational Resources Information Center

Keogh, Katharina; Creaven, Ann-Marie

2017-01-01

In this study we tested whether drawing and coloring influence cardiovascular recovery and perceived stress following exposure to a stressor. In a mixed experimental design, participants (N = 62) completed an acute stress task before being randomly assigned to one of three brief activities: free-form drawing (full creative control), coloring…

Impact of dietary starch concentration formulated with two types corn silage on the performance of dairy cows

USDA-ARS?s Scientific Manuscript database

This study explored the effect of feeding different starch concentrations and conventional or brown midrib corn silage on the performance of lactating dairy cows. Forty-eight Holstein cows were assigned to 1 of 4 diets using a randomized complete block design with a 2-wk covariate period followed by...

Conditions Restraining the Teaching of Major Nigerian Languages in Secondary School in Ebonyi State, Nigeria

ERIC Educational Resources Information Center

Chidi-Ehiem, Ugochi Ijeoma

2015-01-01

This descriptive survey was carried out in order to determine the conditions handicapping the teaching of major Nigerian languages in secondary schools in Ebonyi State, Nigeria. A random sample of 953 students and 602 language teachers completed a corresponding copies of questionnaire designed for the study. Out of 1555 copies of questionnaire…

Influence of pine straw harvesting, prescribed fire, and fertilization on a Louisiana longleaf pine site

Treesearch

James D. Haywood

2009-01-01

This research was initiated in a 34-year-old, direct-seeded stand of longleaf pine (Pinus palustris Mill.) to study how pine straw management practices (harvesting, fire, and fertilization) affected the longleaf pine overstory and pine straw yields. A randomized complete block split-plot design was installed with two main plot treatments...

Design and Methodology of the Trial to Assess Chelation Therapy (TACT)

PubMed Central

Lamas, Gervasio A.; Goertz, Christine; Boineau, Robin; Mark, Daniel B.; Rozema, Theodore; Nahin, Richard L.; Drisko, Jeanne A.; Lee, Kerry L.

2011-01-01

The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored, randomized, double blind, placebo-controlled, 2×2 factorial clinical trial testing the benefits and risks of 40 infusions of a multi-component Na2EDTA-chelation solution compared with placebo, and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow 1708 patients for an average of approximately 4 years. The primary endpoint is a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900 patient substudy will examine quality of life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary endpoint for each treatment factor. Enrollment began in September 2003 and completed in October 2010. PMID:22172430

Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

PubMed

Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

2016-03-01

Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

PubMed

Choi, Woong Gil; Rha, Seung Woon; Choi, Cheol Ung; Kim, Eung Ju; Oh, Dong Joo; Cho, Yoon Hyung; Park, Sang Ho; Lee, Seung Jin; Hur, Ae Yong; Ko, Young Guk; Park, Sang Min; Kim, Ki Chang; Kim, Joo Han; Kim, Min Woong; Kim, Sang Min; Bae, Jang Ho; Bong, Jung Min; Kang, Won Yu; Seo, Jae Bin; Jung, Woo Yong; Cho, Jang Hyun; Kim, Do Hoi; Ahn, Ji Hoon; Kim, Soo Hyun; Jang, Ji Yong

2016-06-25

The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

Conducting pilot and feasibility studies.

PubMed

Cope, Diane G

2015-03-01

Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
.

Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial.

PubMed

You, John J; Liu, Yudong; Kirby, John; Vora, Parag; Moayyedi, Paul

2015-07-09

No head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial. Eligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada, between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated, centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding. A total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated screening procedure was completed by 43 (64%) subjects allocated to FOBT (95% confidence interval [CI], 52-75%), 53 (80%) subjects allocated to OC (95% CI, 69-88%), and 50 (77%) subjects allocated to VC (95% CI, 65-85%); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences in completion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0%) subjects allocated to FOBT, 12 (18%) subjects allocated to OC, and 2 (3%) subjects allocated to VC. One subject in the OC arm had histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer. In this pilot randomized controlled trial of colorectal cancer screening in a primary care setting, 64-80% of subjects completed their allocated screening test. These findings may be of value to investigators planning clinical trials to evaluate the effectiveness of colorectal cancer screening. ClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527.

Optimal sampling design for estimating spatial distribution and abundance of a freshwater mussel population

USGS Publications Warehouse

Pooler, P.S.; Smith, D.R.

2005-01-01

We compared the ability of simple random sampling (SRS) and a variety of systematic sampling (SYS) designs to estimate abundance, quantify spatial clustering, and predict spatial distribution of freshwater mussels. Sampling simulations were conducted using data obtained from a census of freshwater mussels in a 40 X 33 m section of the Cacapon River near Capon Bridge, West Virginia, and from a simulated spatially random population generated to have the same abundance as the real population. Sampling units that were 0.25 m 2 gave more accurate and precise abundance estimates and generally better spatial predictions than 1-m2 sampling units. Systematic sampling with ???2 random starts was more efficient than SRS. Estimates of abundance based on SYS were more accurate when the distance between sampling units across the stream was less than or equal to the distance between sampling units along the stream. Three measures for quantifying spatial clustering were examined: Hopkins Statistic, the Clumping Index, and Morisita's Index. Morisita's Index was the most reliable, and the Hopkins Statistic was prone to false rejection of complete spatial randomness. SYS designs with units spaced equally across and up stream provided the most accurate predictions when estimating the spatial distribution by kriging. Our research indicates that SYS designs with sampling units equally spaced both across and along the stream would be appropriate for sampling freshwater mussels even if no information about the true underlying spatial distribution of the population were available to guide the design choice. ?? 2005 by The North American Benthological Society.

An adapted mindfulness-based stress reduction program for elders in a continuing care retirement community: quantitative and qualitative results from a pilot randomized controlled trial.

PubMed

Moss, Aleezé S; Reibel, Diane K; Greeson, Jeffrey M; Thapar, Anjali; Bubb, Rebecca; Salmon, Jacqueline; Newberg, Andrew B

2015-06-01

The purpose of this study was to test the feasibility and effectiveness of an adapted 8-week Mindfulness-Based Stress Reduction (MBSR) program for elders in a continuing care community. This mixed-methods study used both quantitative and qualitative measures. A randomized waitlist control design was used for the quantitative aspect of the study. Thirty-nine elderly were randomized to MBSR (n = 20) or a waitlist control group (n = 19), mean age was 82 years. Both groups completed pre-post measures of health-related quality of life, acceptance and psychological flexibility, facets of mindfulness, self-compassion, and psychological distress. A subset of MBSR participants completed qualitative interviews. MBSR participants showed significantly greater improvement in acceptance and psychological flexibility and in role limitations due to physical health. In the qualitative interviews, MBSR participants reported increased awareness, less judgment, and greater self-compassion. Study results demonstrate the feasibility and potential effectiveness of an adapted MBSR program in promoting mind-body health for elders. © The Author(s) 2014.

A Randomized Trial of the Impact of Survey Design Characteristics on Response Rates Among Nursing Home Providers

PubMed Central

Clark, Melissa; Rogers, Michelle; Foster, Andrew; Dvorchak, Faye; Saadeh, Frances; Weaver, Jessica; Mor, Vincent

2013-01-01

An experiment was conducted to maximize participation of both the Director of Nursing (DoN) and the Administrator (ADMIN) in long-term care facilities. Providers in each of the 224 randomly selected facilities were randomly assigned to 1 of 16 conditions based on the combination of data collection mode (web vs. mail), questionnaire length (short vs. long), and incentive structure. Incentive structures were determined by amount compensated if the individual completed and an additional amount per individual if the pair completed (a) $30 individual/$5 pair/$35 total; (b) $10 individual/$25 pair/$35 total; (c) $30 individual/$20 pair/$50 total; and (d) $10 individual/$40 pair/$50 total. Overall, 47.4% of eligible respondents participated; both respondents participated in 29.3% of facilities. In multivariable analyses, there were no differences in the likelihood of both respondents participating by mode, questionnaire length, or incentive structure. Providing incentives contingent on participation by both providers of a facility was an ineffective strategy for significantly increasing response rates. PMID:21411474

Treatment fidelity of brief motivational interviewing and health education in a randomized clinical trial to promote dental attendance of low-income mothers and children: Community-Based Intergenerational Oral Health Study "Baby Smiles".

PubMed

Weinstein, Philip; Milgrom, Peter; Riedy, Christine A; Mancl, Lloyd A; Garson, Gayle; Huebner, Colleen E; Smolen, Darlene; Sutherland, Marilynn; Nykamp, Ann

2014-02-24

Fidelity assessments are integral to intervention research but few published trials report these processes in detail. We included plans for fidelity monitoring in the design of a community-based intervention trial. The study design was a randomized clinical trial of an intervention provided to low-income women to increase utilization of dental care during pregnancy (mother) or the postpartum (child) period. Group assignment followed a 2 × 2 factorial design in which participants were randomly assigned to receive either brief Motivational Interviewing (MI) or Health Education (HE) during pregnancy (prenatal) and then randomly reassigned to one of these groups for the postpartum intervention. The study setting was four county health departments in rural Oregon State, USA. Counseling was standardized using a step-by-step manual. Counselors were trained to criteria prior to delivering the intervention and fidelity monitoring continued throughout the implementation period based on audio recordings of counselor-participant sessions. The Yale Adherence and Competence Scale (YACS), modified for this study, was used to code the audio recordings of the counselors' delivery of both the MI and HE interventions. Using Interclass Correlation Coefficients totaling the occurrences of specific MI counseling behaviors, ICC for prenatal was .93, for postpartum the ICC was .75. Participants provided a second source of fidelity data. As a second source of fidelity data, the participants completed the Feedback Questionnaire that included ratings of their satisfaction with the counselors at the completion of the prenatal and post-partum interventions. Coding indicated counselor adherence to MI protocol and variation among counselors in the use of MI skills in the MI condition. Almost no MI behaviors were found in the HE condition. Differences in the length of time to deliver intervention were found; as expected, the HE intervention took less time. There were no differences between the overall participants' satisfaction ratings of the HE and MI sessions by individual counselor or overall (p > .05). Trial design, protocol specification, training, and continuous supervision led to a high degree of treatment fidelity for the counseling interventions in this randomized clinical trial and will increase confidence in the interpretation of the trial findings.

Improvement of Automated POST Case Success Rate Using Support Vector Machines

NASA Technical Reports Server (NTRS)

Zwack, Matthew R.; Dees, Patrick D.

2017-01-01

During early conceptual design of complex systems, concept down selection can have a large impact upon program life-cycle cost. Therefore, any concepts selected during early design will inherently commit program costs and affect the overall probability of program success. For this reason it is important to consider as large a design space as possible in order to better inform the down selection process. For conceptual design of launch vehicles, trajectory analysis and optimization often presents the largest obstacle to evaluating large trade spaces. This is due to the sensitivity of the trajectory discipline to changes in all other aspects of the vehicle design. Small deltas in the performance of other subsystems can result in relatively large fluctuations in the ascent trajectory because the solution space is non-linear and multi-modal [1]. In order to help capture large design spaces for new launch vehicles, the authors have performed previous work seeking to automate the execution of the industry standard tool, Program to Optimize Simulated Trajectories (POST). This work initially focused on implementation of analyst heuristics to enable closure of cases in an automated fashion, with the goal of applying the concepts of design of experiments (DOE) and surrogate modeling to enable near instantaneous throughput of vehicle cases [2]. Additional work was then completed to improve the DOE process by utilizing a graph theory based approach to connect similar design points [3]. The conclusion of the previous work illustrated the utility of the graph theory approach for completing a DOE through POST. However, this approach was still dependent upon the use of random repetitions to generate seed points for the graph. As noted in [3], only 8% of these random repetitions resulted in converged trajectories. This ultimately affects the ability of the random reps method to confidently approach the global optima for a given vehicle case in a reasonable amount of time. With only an 8% pass rate, tens or hundreds of thousands of reps may be needed to be confident that the best repetition is at least close to the global optima. However, typical design study time constraints require that fewer repetitions be attempted, sometimes resulting in seed points that have only a handful of successful completions. If a small number of successful repetitions are used to generate a seed point, the graph method may inherit some inaccuracies as it chains DOE cases from the non-global-optimal seed points. This creates inherent noise in the graph data, which can limit the accuracy of the resulting surrogate models. For this reason, the goal of this work is to improve the seed point generation method and ultimately the accuracy of the resulting POST surrogate model. The work focuses on increasing the case pass rate for seed point generation.

Costs of pulmonary rehabilitation and predictors of adherence in the National Emphysema Treatment Trial.

PubMed

Fan, Vincent S; Giardino, Nicholas D; Blough, David K; Kaplan, Robert M; Ramsey, Scott D

2008-04-01

This study reports the costs associated with rehabilitation among participants in the National Emphysema Treatment Trial (NETT), and evaluates factors associated with adherence to rehabilitation. Pulmonary rehabilitation is recommended for moderate-to-severe COPD and required by the Centers for Medicare and Medicaid Services (CMS) prior to lung volume reduction surgery (LVRS). Between January 1998 and July 2002, 1,218 subjects with emphysema and severe airflow limitation (FEV(1) < or = 45% predicted) were randomized. Primary outcome measures were designated as mortality and maximal exercise capacity 2 years after randomization. Pre-randomization, estimated mean total cost per patient of rehabilitation was $2,218 (SD $314; 2006 dollars) for the medical group and $2,187 (SD $304) for the surgical group. Post-randomization, mean cost per patient in the medical and surgical groups was $766 and $962 respectively. Among patients who attended > or = 1 post-randomization rehabilitation session, LVRS patients, patients with an FEV(1) > or = 20% predicted, and higher education were significantly more likely to complete rehabilitation. Patients with depressive and anxiety symptoms, and those who live > 36 miles compared to < 6 miles away were less likely to be adherent. Patients who underwent LVRS completed more exercise sessions than those in the medical group and were more likely to be adherent with post-randomization rehabilitation. A better understanding of patient factors such as socioeconomic status, depression, anxiety and transportation issues may improve adherence to pulmonary rehabilitation.

Complete convergence of randomly weighted END sequences and its application.

PubMed

Li, Penghua; Li, Xiaoqin; Wu, Kehan

2017-01-01

We investigate the complete convergence of partial sums of randomly weighted extended negatively dependent (END) random variables. Some results of complete moment convergence, complete convergence and the strong law of large numbers for this dependent structure are obtained. As an application, we study the convergence of the state observers of linear-time-invariant systems. Our results extend the corresponding earlier ones.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD).

PubMed

Saunders, Gabrielle H; Biswas, Kousick; Serpi, Tracey; McGovern, Stephanie; Groer, Shirley; Stock, Eileen M; Magruder, Kathryn M; Storzbach, Daniel; Skelton, Kelly; Abrams, Thad; McCranie, Mark; Richerson, Joan; Dorn, Patricia A; Huang, Grant D; Fallon, Michael T

2017-11-01

Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD. Trial design considerations prioritized participant and intervention (dog) safety, selection of an intervention comparison group that would optimize enrollment in all treatment arms, pragmatic methods to ensure healthy well-trained dogs, and the selection of outcomes for achieving scientific and clinical validity in a Veteran PTSD population. Since there is no blueprint for conducting a randomized clinical trial examining the impact of dogs on PTSD of this size and scope, it is our primary intent that the successful completion of this trial will set a benchmark for future trial design and scientific rigor, as well as guiding researchers aiming to better understand the role that dogs can have in the management of Veterans experiencing mental health conditions such as PTSD. Published by Elsevier Inc.

CENTRAL, PEDro, PubMed, and EMBASE are the most comprehensive databases indexing randomized controlled trials of physical therapy interventions.

PubMed

Michaleff, Zoe A; Costa, Leonardo O P; Moseley, Anne M; Maher, Christopher G; Elkins, Mark R; Herbert, Robert D; Sherrington, Catherine

2011-02-01

Many bibliographic databases index research studies evaluating the effects of health care interventions. One study has concluded that the Physiotherapy Evidence Database (PEDro) has the most complete indexing of reports of randomized controlled trials of physical therapy interventions, but the design of that study may have exaggerated estimates of the completeness of indexing by PEDro. The purpose of this study was to compare the completeness of indexing of reports of randomized controlled trials of physical therapy interventions by 8 bibliographic databases. This study was an audit of bibliographic databases. Prespecified criteria were used to identify 400 reports of randomized controlled trials from the reference lists of systematic reviews published in 2008 that evaluated physical therapy interventions. Eight databases (AMED, CENTRAL, CINAHL, EMBASE, Hooked on Evidence, PEDro, PsycINFO, and PubMed) were searched for each trial report. The proportion of the 400 trial reports indexed by each database was calculated. The proportions of the 400 trial reports indexed by the databases were as follows: CENTRAL, 95%; PEDro, 92%; PubMed, 89%; EMBASE, 88%; CINAHL, 53%; AMED, 50%; Hooked on Evidence, 45%; and PsycINFO, 6%. Almost all of the trial reports (99%) were found in at least 1 database, and 88% were indexed by 4 or more databases. Four trial reports were uniquely indexed by a single database only (2 in CENTRAL and 1 each in PEDro and PubMed). The results are only applicable to searching for English-language published reports of randomized controlled trials evaluating physical therapy interventions. The 4 most comprehensive databases of trial reports evaluating physical therapy interventions were CENTRAL, PEDro, PubMed, and EMBASE. Clinicians seeking quick answers to clinical questions could search any of these databases knowing that all are reasonably comprehensive. PEDro, unlike the other 3 most complete databases, is specific to physical therapy, so studies not relevant to physical therapy are less likely to be retrieved. Researchers could use CENTRAL, PEDro, PubMed, and EMBASE in combination to conduct exhaustive searches for randomized trials in physical therapy.

Isotropic band gaps and freeform waveguides observed in hyperuniform disordered photonic solids

PubMed Central

Man, Weining; Florescu, Marian; Williamson, Eric Paul; He, Yingquan; Hashemizad, Seyed Reza; Leung, Brian Y. C.; Liner, Devin Robert; Torquato, Salvatore; Chaikin, Paul M.; Steinhardt, Paul J.

2013-01-01

Recently, disordered photonic media and random textured surfaces have attracted increasing attention as strong light diffusers with broadband and wide-angle properties. We report the experimental realization of an isotropic complete photonic band gap (PBG) in a 2D disordered dielectric structure. This structure is designed by a constrained optimization method, which combines advantages of both isotropy due to disorder and controlled scattering properties due to low-density fluctuations (hyperuniformity) and uniform local topology. Our experiments use a modular design composed of Al2O3 walls and cylinders arranged in a hyperuniform disordered network. We observe a complete PBG in the microwave region, in good agreement with theoretical simulations, and show that the intrinsic isotropy of this unique class of PBG materials enables remarkable design freedom, including the realization of waveguides with arbitrary bending angles impossible in photonic crystals. This experimental verification of a complete PBG and realization of functional defects in this unique class of materials demonstrate their potential as building blocks for precise manipulation of photons in planar optical microcircuits and has implications for disordered acoustic and electronic band gap materials. PMID:24043795

The Effects of Low Atmosphere Stunning and Deboning Time on Broiler Breast Meat Quality

USDA-ARS?s Scientific Manuscript database

A randomized complete block design with 3 replications (n = 432, 72 broilers per treatment) was used to evaluate the effects of electrical (ES) and vacuum stunning (VS) on broiler breast meat quality. Electrical stunning was performed by applying 11.5 V, <0.05 mA, AC to DC current for 3 s for each b...

Effects of soil compaction, forest leaf litter and nitrogen fertilizer on two oak species and microbial activity

Treesearch

D. Jordan; F., Jr. Ponder; V. C. Hubbard

2003-01-01

A greenhouse study examined the effects of soil compaction and forest leaf litter on the growth and nitrogen (N) uptake and recovery of red oak (Quercus rubra L.) and scarlet oak (Quercus coccinea Muencch) seedlings and selected microbial activity over a 6-month period. The experiment had a randomized complete block design with...

Effects of bale feeder type and supplementation of monensin on hay waste, intake, and performance of beef cattle

USDA-ARS?s Scientific Manuscript database

The effects of feeder type and supplemental monensin on hay utilization in beef cows was investigated using 56 crossbred beef cows (BW= 494 ± 50 kg; BCS= 5.2 ± 0.5) in a split-plot treatment arrangement with a completely randomized design. Supplement treatment served as the main plot and feeder desi...

Assessing benefits and risk of using flue gas desulfurized gypsum (FGDG) as soil amendment in a Coastal Plain soil

USDA-ARS?s Scientific Manuscript database

The influence of FGDG and grass buffers on runoff water quality and corn production following poultry litter (PL) application is being evaluated as part of a regional USDA-ARS project (Auburn-AL, Oxford-MS, and Tifton-GA). Treatments at Tifton were laid out in a randomized complete block design wit...

The Validity of the Major Field Test in Psychology as a Programme Assessment Tool

ERIC Educational Resources Information Center

Gallagher, Shawn P.; Cook, Shaun P.

2013-01-01

The Major Field Test in Psychology (MFT) is a standardised test designed to assess subject mastery at the conclusion of an undergraduate career. Eighty-one graduating majors completed the MFT and 56 of them also took a multiple-choice exam of questions drawn randomly from an introductory psychology test bank. Like the MFT, the constructed exam was…

Effect of midrotation fertilization on growth and specific gravity of loblolly pine

Treesearch

Finto Antony; Lewis Jordan; Richard F. Daniels; Laurence R. Schimleck; Alexander Clark III; Daniel B. Hall

2009-01-01

Wood properties and growth were measured on breast-height cores and on disks collected at different heights from a thinned and fertilized midrotation loblolly pine (Pinus taeda L.) plantation in the lower Coastal Plain of North Carolina. The study was laid out in a randomized complete-block design receiving four levels of nitrogen (N) fertilizer: unfertilized...

Effects of herbaceous and woody plant control on longleaf pine growth and understory plant cover

Treesearch

James D. Haywood

2013-01-01

To determine if either herbaceous or woody plants are more competitive with longleaf pine (Pinus palustris Mill.) trees, four vegetation management treatments— check, herbaceous plant control (HPC), woody plant control (WPC), and HPC+WPC—were applied in newly established longleaf pine plantings in a randomized complete block design in two studies....

Continuous, low-dose oral exposure to sodium chlorate reduces fecal Enterobacteriaceae coliforms in sheep feces without inducing subclinical chlorate toxicosis

USDA-ARS?s Scientific Manuscript database

Our objectives were to determine a minimal daily dose of sodium chlorate, to be included in the drinking water for 5 days, that is safe yet maintains efficacy in reducing fecal shedding of Escherichia coli in mature ewes. In a complete randomized experimental design, 25 Targhee ewes (age = 18- to 20...

Comparing effects of fire modeling methods on simulated fire patterns and succession: a case study in the Missouri Ozarks

Treesearch

Jian Yang; Hong S. He; Brian R. Sturtevant; Brian R. Miranda; Eric J. Gustafson

2008-01-01

We compared four fire spread simulation methods (completely random, dynamic percolation. size-based minimum travel time algorithm. and duration-based minimum travel time algorithm) and two fire occurrence simulation methods (Poisson fire frequency model and hierarchical fire frequency model) using a two-way factorial design. We examined these treatment effects on...

Seasonal Biennial Burning and Woody Plant Control Influence Native Vegetation in Loblolly Pine Stands

Treesearch

James D. Haywood; Alton Martin; Henry A. Pearson; Harold E. Grelen

1998-01-01

This paper documents the results of a study to determine the effects of selectedvegetation-management treatments in loblolly pine. Vegetation in precommercially thinned, 6-year-old stands was subjected to five biennial growing season burns in either early March, May, or July coupled with hand felling of residual woody stems. Using a randomized complete block design, we...

Effects of D-a-tocopherol and dietary energy on growth and health of preruminant dairy calves

USDA-ARS?s Scientific Manuscript database

To observe the effects of supplemental dietary d-a-tocopherol in relation to dietary energy on growth and immune status in dairy calves, 32 newborn Holstein bull calves were assigned to 1 of 4 treatments for 5 weeks in a 2x2 factorial randomized complete block, split-plot design. Calves received mod...

Effects of d-a-Tocopherol and Dietary Energy on Growth and Health of Pre-ruminant Dairy Calves

USDA-ARS?s Scientific Manuscript database

To observe the effects of supplemental dietary d-a-tocopherol in relation to dietary energy on growth and immune status in dairy calves, 32 newborn Holstein bull calves were assigned to 1 of 4 treatments for 5 wks in a 2x2 factorial randomized complete block, split-plot design. Calves received moder...

Chromium supplementation alters the performance and health of feedlot cattle during the receiving period and enhances their metabolic response to a lipopolysaccharide challenge

USDA-ARS?s Scientific Manuscript database

Crossbred steers (n = 180; 230 +/- 6 kg) were fed during a 56-d receiving period to determine if supplementing chromium (Cr; KemTRACE®brandChromiumPropionate0.04%, Kemin Industries) would improve feedlot performance and health of newly-received cattle. A completely randomized block design (36 pens; ...

Performance of mixed pine-hardwood stands 16 years after fell-and-burn treatments

Treesearch

Elizabeth M. Blizzard; David H. van Lear; G. Geoff Wang; Thomas A. Waldrop

2006-01-01

Four variations of the fell-and-burn technique were compared for height and volume production on dry Piedmont sites. A two-factorial randomized complete block design of winter versus spring felling, with and without a summer burn, was implemented, followed by planting of loblolly pine (Pinus taeda L.) at 15 x 15 foot spacing. After 16 growing seasons...

A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial.

PubMed

Krishnamurti, Tamar; Argo, Nichole

2016-08-01

Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Results suggest that providing concise informed consent content, systematically developed from patients' self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment. © The Author(s) 2016.

Multicenter Randomized Controlled Trial on Duration of Therapy for Thrombosis in Children and Young Adults (Kids-DOTT): Pilot/Feasibility Phase Findings

PubMed Central

Goldenberg, N.A.; Abshire, T.; Blatchford, P.J.; Fenton, L.Z.; Halperin, J.L.; Hiatt, W.R.; Kessler, C.M.; Kittelson, J.M.; Manco-Johnson, M.J.; Spyropoulos, A.C.; Steg, P.G.; Stence, N.V.; Turpie, A.G.G.; Schulman, S.

2015-01-01

BACKGROUND Randomized controlled trials (RCTs) in pediatric venous thromboembolism (VTE) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. METHODS Kids-DOTT is a multicenter RCT investigating non-inferiority of a 6-week (shortened) vs. 3-month (conventional) duration of anticoagulation in patients <21 years old with provoked venous thrombosis. Primary efficacy and safety endpoints are symptomatic recurrent VTE at 1 year and anticoagulant-related, clinically-relevant bleeding. In the P/F phase, 100 participants were enrolled in an open, blinded endpoint, parallel-cohort RCT design. RESULTS No eligibility violations or randomization errors occurred. Of enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in pre-specified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. Retention at 1 year was 82%. Inter-observer agreement between local vs. blinded central determination of venous occlusion by imaging at 6 weeks post-diagnosis was strong (κ-statistic=0.75; 95% confidence interval [CI] 0.48–1.0). Primary efficacy and safety event rates were 3.3% (95% CI 0.3–11.5%) and 1.4% (0.03–7.4%). CONCLUSIONS The P/F phase of Kids-DOTT has demonstrated validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention, and endpoint rates to inform the fully-powered RCT. PMID:26118944

On the use of secondary capture-recapture samples to estimate temporary emigration and breeding proportions

USGS Publications Warehouse

Kendall, W.L.; Nichols, J.D.; North, P.M.; Nichols, J.D.

1995-01-01

The use of the Cormack- Jolly-Seber model under a standard sampling scheme of one sample per time period, when the Jolly-Seber assumption that all emigration is permanent does not hold, leads to the confounding of temporary emigration probabilities with capture probabilities. This biases the estimates of capture probability when temporary emigration is a completely random process, and both capture and survival probabilities when there is a temporary trap response in temporary emigration, or it is Markovian. The use of secondary capture samples over a shorter interval within each period, during which the population is assumed to be closed (Pollock's robust design), provides a second source of information on capture probabilities. This solves the confounding problem, and thus temporary emigration probabilities can be estimated. This process can be accomplished in an ad hoc fashion for completely random temporary emigration and to some extent in the temporary trap response case, but modelling the complete sampling process provides more flexibility and permits direct estimation of variances. For the case of Markovian temporary emigration, a full likelihood is required.

Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

PubMed

Silverman, Michael J

2013-10-01

Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

A multiobjective hybrid genetic algorithm for the capacitated multipoint network design problem.

PubMed

Lo, C C; Chang, W H

2000-01-01

The capacitated multipoint network design problem (CMNDP) is NP-complete. In this paper, a hybrid genetic algorithm for CMNDP is proposed. The multiobjective hybrid genetic algorithm (MOHGA) differs from other genetic algorithms (GAs) mainly in its selection procedure. The concept of subpopulation is used in MOHGA. Four subpopulations are generated according to the elitism reservation strategy, the shifting Prufer vector, the stochastic universal sampling, and the complete random method, respectively. Mixing these four subpopulations produces the next generation population. The MOHGA can effectively search the feasible solution space due to population diversity. The MOHGA has been applied to CMNDP. By examining computational and analytical results, we notice that the MOHGA can find most nondominated solutions and is much more effective and efficient than other multiobjective GAs.

Development of a Novel Six-Month Nutrition Intervention for a Randomized Trial in Older Men with Mobility Limitations.

PubMed

Apovian, C M; Singer, M R; Campbell, W W; Bhasin, S; McCarthy, A C; Shah, M; Basaria, S; Moore, L L

2017-01-01

Nutrition impacts the development of sarcopenia and protein intake is an important modulator of skeletal muscle mass loss in older people. The Optimizing Protein Intake in Older Men with Mobility Limitation (OPTIMEN) Trial was designed to assess the independent and combined effects of higher protein intake and a promyogenic agent, testosterone, on lean body mass, muscle strength and physical function in older men with mobility disability. The purpose of this paper is to describe the experimental design and nutrition intervention, including techniques used by research dietitians to develop and deliver energy and protein-specific meals to the homes of community-dwelling participants. Strategies to enhance long-term dietary compliance are detailed. Randomized, double-blind, placebo-controlled six-month intervention trial. Participants were recruited from Boston MA USA and surrounding communities. Older men who were mobility-limited (Short Physical Performance Battery (SPPB) 3-10) and consuming less protein (<0.83 g/kg/day) were recruited for this study. Here we report the successful implementation of a double-blind, placebo-controlled, parallel group, randomized controlled trial with a 6-month intervention period among community-living men, age 65 years and older with a mobility limitation. A controlled feeding plan was used to deliver required energy intakes and prescribed protein quantities of 0.8 or 1.3 grams/kilogram/day (g/kg/d) in three meals plus snacks and supplements. A 2x2 factorial design was used to assess the effects of protein level alone and in combination with testosterone (vs. placebo) on changes in lean body mass (primary outcome), muscle strength, and physical function. A total of 154 men met the eligibility criteria; 112 completed a 2-week run-in period designed to evaluate compliance with the nutrition intervention. Of these, 92 subjects met compliance eligibility criteria and agreed to be randomized; 85% completed the full trial. The study successfully delivered three meals per day to subjects, with a high degree of compliance and subject satisfaction. Overall self-reported compliance rates were 80% and 93% for the meals and supplements, respectively. Details of compliance strategies are discussed. This community-based study design may serve as a model for longer-term nutritional interventions requiring monitoring of dietary compliance in a home-based feeding and supplementation trial.

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

PubMed

Brenner, Alison T; Getrich, Christina M; Pignone, Michael; Rhyne, Robert L; Hoffman, Richard M; McWilliams, Andrew; de Hernandez, Brisa Urquieta; Weaver, Mark A; Tapp, Hazel; Harbi, Khalil; Reuland, Daniel

2014-07-08

Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. ClinicalTrials.gov NCT02054598.

On-plant movement and feeding of western bean cutworm (Lepidoptera: Noctuidae) early instars on corn.

PubMed

Paula-Moraes, S V; Hunt, T E; Wright, R J; Hein, G L; Blankenship, E E

2012-12-01

Western bean cutworm, Striacosta albicosta (Smith), has undergone a recent eastward expansion from the western U.S. Corn Belt to Pennsylvania and parts of Canada. Little is known about its ecology and behavior, particularly during the early instars, on corn (Zea mays L.). There is a narrow treatment window for larvae, and early detection of the pest in the field is essential. An understanding of western bean cutworm larval feeding and early-instar dispersal is essential to understand larval survival and establishment in corn. Studies were conducted in 2009 through 2011 in Nebraska to determine the feeding and dispersal of early-instar western bean cutworm on corn. The treatment design was a factorial with three corn stages (pretassel, tassel, and posttassel) and five corn plant zones (tassel, above ear, primary ear, secondary ear, and below ear) in a randomized complete block design. The effects of different corn tissues on larval survival and development were investigated in laboratory studies in a randomized complete block design during 2009 and 2011. Treatments were different corn tissues (leaf alone, leaf with developing tassel, pollen, pollen plus silk, and silk alone). Results demonstrated that neonate larvae move to the upper part of the plant, independent of corn stage. Larval growth was optimal when fed on tassel tissue. Overall results indicated a selective benefit for movement of the early instar to upper part of the plant.

Virtual versus face-to-face clinical simulation in relation to student knowledge, anxiety, and self-confidence in maternal-newborn nursing: A randomized controlled trial.

PubMed

Cobbett, Shelley; Snelgrove-Clarke, Erna

2016-10-01

Clinical simulations can provide students with realistic clinical learning environments to increase their knowledge, self-confidence, and decrease their anxiety prior to entering clinical practice settings. To compare the effectiveness of two maternal newborn clinical simulation scenarios; virtual clinical simulation and face-to-face high fidelity manikin simulation. Randomized pretest-posttest design. A public research university in Canada. Fifty-six third year Bachelor of Science in Nursing students. Participants were randomized to either face-to-face or virtual clinical simulation and then to dyads for completion of two clinical simulations. Measures included: (1) Nursing Anxiety and Self-Confidence with Clinical Decision Making Scale (NASC-CDM) (White, 2011), (2) knowledge pretest and post-test related to preeclampsia and group B strep, and (3) Simulation Completion Questionnaire. Before and after each simulation students completed a knowledge test and the NASC-CDM and the Simulation Completion Questionnaire at study completion. There were no statistically significant differences in student knowledge and self-confidence between face-to-face and virtual clinical simulations. Anxiety scores were higher for students in the virtual clinical simulation than for those in the face-to-face simulation. Students' self-reported preference was face-to-face citing the similarities to practicing in a 'real' situation and the immediate debrief. Students not liking the virtual clinical simulation most often cited technological issues as their rationale. Given the equivalency of knowledge and self-confidence when undergraduate nursing students participate in either maternal newborn clinical scenarios of face-to-face or virtual clinical simulation identified in this trial, it is important to take into the consideration costs and benefits/risks of simulation implementation. Copyright © 2016 Elsevier Ltd. All rights reserved.

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

PubMed

Meltzer, Lauren R; Simmons, Vani N; Sutton, Steven K; Drobes, David J; Quinn, Gwendolyn P; Meade, Cathy D; Unrod, Marina; Brandon, Karen O; Harrell, Paul T; Eissenberg, Thomas; Bullen, Christopher R; Brandon, Thomas H

2017-09-01

Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated. Copyright © 2017 Elsevier Inc. All rights reserved.

"Fair Play": A Videogame Designed to Address Implicit Race Bias Through Active Perspective Taking.

PubMed

Gutierrez, Belinda; Kaatz, Anna; Chu, Sarah; Ramirez, Dennis; Samson-Samuel, Clem; Carnes, Molly

2014-12-01

Having diverse faculty in academic health centers will help diversify the healthcare workforce and reduce health disparities. Implicit race bias is one factor that contributes to the underrepresentation of Black faculty. We designed the videogame "Fair Play" in which players assume the role of a Black graduate student named Jamal Davis. As Jamal, players experience subtle race bias while completing "quests" to obtain a science degree. We hypothesized that participants randomly assigned to play the game would have greater empathy for Jamal and lower implicit race bias than participants randomized to read narrative text describing Jamal's experience. University of Wisconsin-Madison graduate students were recruited via e-mail and randomly assigned to play "Fair Play" or read narrative text through an online link. Upon completion, participants took an Implicit Association Test to measure implicit bias and answered survey questions assessing empathy toward Jamal and awareness of bias. As hypothesized, gameplayers showed the least implicit bias but only when they also showed high empathy for Jamal (P=0.013). Gameplayers did not show greater empathy than text readers, and women in the text condition reported the greatest empathy for Jamal (P=0.008). However, high empathy only predicted lower levels of implicit bias among those who actively took Jamal's perspective through gameplay (P=0.014). A videogame in which players experience subtle race bias as a Black graduate student has the potential to reduce implicit bias, possibly because of a game's ability to foster empathy through active perspective taking.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

PubMed Central

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-01-01

Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. PMID:27212005

Complete Numerical Solution of the Diffusion Equation of Random Genetic Drift

PubMed Central

Zhao, Lei; Yue, Xingye; Waxman, David

2013-01-01

A numerical method is presented to solve the diffusion equation for the random genetic drift that occurs at a single unlinked locus with two alleles. The method was designed to conserve probability, and the resulting numerical solution represents a probability distribution whose total probability is unity. We describe solutions of the diffusion equation whose total probability is unity as complete. Thus the numerical method introduced in this work produces complete solutions, and such solutions have the property that whenever fixation and loss can occur, they are automatically included within the solution. This feature demonstrates that the diffusion approximation can describe not only internal allele frequencies, but also the boundary frequencies zero and one. The numerical approach presented here constitutes a single inclusive framework from which to perform calculations for random genetic drift. It has a straightforward implementation, allowing it to be applied to a wide variety of problems, including those with time-dependent parameters, such as changing population sizes. As tests and illustrations of the numerical method, it is used to determine: (i) the probability density and time-dependent probability of fixation for a neutral locus in a population of constant size; (ii) the probability of fixation in the presence of selection; and (iii) the probability of fixation in the presence of selection and demographic change, the latter in the form of a changing population size. PMID:23749318

Is a videotape to change beliefs and behaviors superior to a standard videotape in acute low back pain? A randomized controlled trial.

PubMed

Newcomer, Karen L; Vickers Douglas, Kristin S; Shelerud, Randy A; Long, Kirsten Hall; Crawford, Brianna

2008-01-01

Cognitive behavioral therapy has been used successfully in acute low back pain (LBP) treatment, but the use of a cognitive behavioral videotape as an adjunct to treatment has not been studied. To determine outcomes for patients with acute LBP receiving a videotape designed to change beliefs and behaviors compared with a standard instructional videotape. Randomized controlled trial; multidisciplinary clinic in an academic setting. Consecutive subjects with less than 3 months of LBP. Of 224 eligible subjects, 138 participated and completed the initial questionnaires. Oswestry Disability Index, Pain and Impairment Relationship Scale, Fear-Avoidance Beliefs Questionnaire; medical costs related to LBP and total medical costs incurred by participants during 1 year of follow-up. Subjects were randomly assigned to receive a behavioral videotape or a control videotape. Other than the videotape, usual care was provided to each patient. No significant differences in any outcome measures or medical costs between the two groups at 12 months. However, baseline Vermont Disability Prediction Questionnaire was significantly lower in those who completed the entire study compared with those who did not complete the study. Compared with a standard instructional videotape, a behavioral videotape did not change beliefs, outcomes, or costs over 1 year. Cost-effective behavioral interventions with high patient retention rates are needed, especially for those at greatest risk of high utilization of resources.

Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.

PubMed

Rignon-Bret, Christophe; Hadida, Alain; Aidan, Alexis; Nguyen, Thien-Huong; Pasquet, Gerard; Fron-Chabouis, Helene; Wulfman, Claudine

2016-05-20

Bone preservation is an essential issue in the context of last teeth extraction and complete edentulism. The intended treatment, whether a complete denture or an implant placement, is facilitated with a voluminous residual ridge. Bone resorption after multiple extractions has not been as well studied as the bone resorption that occurs after the extraction of a single tooth. Recent advances in bone substitute materials have revived this issue. The purpose of this study is to evaluate the interest in using bone substitute material to fill the socket after last teeth extraction in a maxillary immediate complete denture procedure compared with the conventional protocol without socket filling. A randomized, controlled, clinical trial was designed. The 34 participants eligible for maxillary immediate complete denture were divided into two groups. Complete dentures were prepared despite persistence of the last anterior teeth. The control group received a conventional treatment including denture placement immediately after extractions. In the experimental group, in addition to the immediate denture placement, a xenograft bone-substitute material (Bio-Oss Collagen®) was placed in the fresh sockets. The primary outcome of the study is to compare mean bone ridge height loss 1 year after maxillary immediate complete denture placement, with or without bone-substitute material, in incisor and canine sockets. The secondary outcomes are to compare the average bone ridge height and width loss for each extraction site. An original quantitative evaluation method using cone beam computed tomography was designed for reproducible measurements, with a radio-opaque denture duplicate. Two independent operators perform the radiologic measurements. The immediate complete denture technique limits bone resorption in multiple extraction situations and thus allows better denture retention and better options for implant placement. To compare the benefit of using any bone socket-filling material, we proposed a quantitative evaluation protocol of resorption in the specific case of the last anterior maxillary teeth extraction with immediate denture placement. ClinicalTrials.gov, NCT02120053 . Registered on 18 April 2014.

Methods of learning in statistical education: Design and analysis of a randomized trial

NASA Astrophysics Data System (ADS)

Boyd, Felicity Turner

Background. Recent psychological and technological advances suggest that active learning may enhance understanding and retention of statistical principles. A randomized trial was designed to evaluate the addition of innovative instructional methods within didactic biostatistics courses for public health professionals. Aims. The primary objectives were to evaluate and compare the addition of two active learning methods (cooperative and internet) on students' performance; assess their impact on performance after adjusting for differences in students' learning style; and examine the influence of learning style on trial participation. Methods. Consenting students enrolled in a graduate introductory biostatistics course were randomized to cooperative learning, internet learning, or control after completing a pretest survey. The cooperative learning group participated in eight small group active learning sessions on key statistical concepts, while the internet learning group accessed interactive mini-applications on the same concepts. Controls received no intervention. Students completed evaluations after each session and a post-test survey. Study outcome was performance quantified by examination scores. Intervention effects were analyzed by generalized linear models using intent-to-treat analysis and marginal structural models accounting for reported participation. Results. Of 376 enrolled students, 265 (70%) consented to randomization; 69, 100, and 96 students were randomized to the cooperative, internet, and control groups, respectively. Intent-to-treat analysis showed no differences between study groups; however, 51% of students in the intervention groups had dropped out after the second session. After accounting for reported participation, expected examination scores were 2.6 points higher (of 100 points) after completing one cooperative learning session (95% CI: 0.3, 4.9) and 2.4 points higher after one internet learning session (95% CI: 0.0, 4.7), versus nonparticipants or controls, adjusting for other performance predictors. Students who preferred learning by reflective observation and active experimentation experienced improved performance through internet learning (5.9 points, 95% CI: 1.2, 10.6) and cooperative learning (2.9 points, 95% CI: 0.6, 5.2), respectively. Learning style did not influence study participation. Conclusions. No performance differences by group were observed by intent-to-treat analysis. Participation in active learning appears to improve student performance in an introductory biostatistics course and provides opportunities for enhancing understanding beyond that attained in traditional didactic classrooms.

The behavioral dynamics of clinical trials.

PubMed

Leventhal, H; Nerenz, D R; Leventhal, E A; Love, R R; Bendena, L M

1991-01-01

Two ways of approaching the design of long-term clinical trials are presented and contrasted. The first, termed the "static" view, emphasizes close adherence to formal rules of study design. The second, termed the "dynamic" view, emphasizes the behavioral aspects of patient participation in trials of long duration. The dynamic view is discussed in detail, with discussion of how recruitment of participants, random assignment to conditions, compliance with protocol, and measurement of outcomes are affected by behavioral dynamics. Data from a recently completed tamoxifen toxicity trial are used to illustrate the points and to focus the discussion of behavioral dynamics on the design of a chemoprevention trial for breast cancer using tamoxifen.

The Quantitative Effect of Students Using Podcasts in a First Year Undergraduate Exercise Physiology Module

ERIC Educational Resources Information Center

Abt, Grant; Barry, Tim

2007-01-01

This study reports the quantitative effect of students using podcasts in a 1st year undergraduate exercise physiology module. From a cohort of 70 students, 50 volunteered and completed the study. Using a pre-post random allocation research design, students were allocated to either a podcast group (PG) or control group (CG) based on a 32-question…

A Mixed Method Study of the Effectiveness of the Accelerated Reader Program on Middle School Students' Reading Achievement and Motivation

ERIC Educational Resources Information Center

Huang, SuHua

2012-01-01

The mixed-method explanatory research design was employed to investigate the effectiveness of the Accelerated Reader (AR) program on middle school students' reading achievement and motivation. A total of 211 sixth to eighth-grade students provided quantitative data by completing an AR Survey. Thirty of the 211 students were randomly selected to…

Personal Health Risks Behaviour Profile among University Students in the South East Nigeria: Implication for Health Education

ERIC Educational Resources Information Center

Ilo, Cajetan I.; Onwunaka, Chinagorom; Nwimo, Ignatius O.

2015-01-01

This descriptive survey was carried out in order to determine the personal health risks behaviour profile among university students in the south east of Nigeria. A random sample of 900 students completed the questionnaire designed for the study. Out of this number 821, representing about 91.2% return rate, were used for data analysis. Means and…

Habitat use of two songbird species in pine-hardwood forests treated with prescribed burning and thinning: first year results

Treesearch

Jill M. Wick; Yong Wang

2010-01-01

We evaluated habitat use and home range size of hooded warblers (Wilsonia citrine) and worm-eating warblers (Helmitheros vermivorus) in six treated mixed oak-pine stands on the Bankhead National Forest in north-central AL. Study design is a randomized complete block with a factorial arrangement of three thinning levels (no thin, 11...

Feeding fat from distillers dried grains with solubles to dairy heifers: III. Effects on long-term reproductive and lactation performance

USDA-ARS?s Scientific Manuscript database

During the prepubertal growth phase, 33 Holstein heifers (133 ± 18 d old) were used in a 24-week randomized complete block design. Treatments included: 1) a control diet (CON) containing ground corn (15.9% of DM) and soybean products (17.9%); 2) a low-fat diet (LFDG) formulated with 21.9% fat-extrac...

CTN-194 (PICCO): design of a trial of citalopram for the prevention of depression and its consequences in HIV-hepatitis C co-infected individuals initiating pegylated interferon/ribavirin therapy.

PubMed

Klein, Marina B; Cooper, Curtis; Brouillette, Marie-Josée; Sheehan, Nancy L; Benkelfat, Chawki; Annable, Lawrence; Weston, Francine; Kraus, Deborah; Singer, Joel

2008-07-01

Hepatitis C (HCV)-related end stage liver disease is a primary cause of morbidity and mortality in people with HIV. Despite this, co-infected patients have low rates of HCV treatment initiation and completion. This is in large part due to the risk of pegylated-interferon alpha (PEG-IFN-alpha)-related neuropsychiatric complications. We describe the design of a multicentre randomized, placebo-controlled trial that evaluates whether antidepressant prophylaxis is superior to early detection and treatment of depression in increasing the successful completion of HCV therapy. Seventy-six HIV+ adults with chronic HCV infection requiring therapy and with no contraindications to PEG-IFN-alpha/ribavirin will be randomized in a 1:1 ratio to receive citalopram or placebo starting three weeks prior to HCV treatment. A novel aspect of the trial design is the built-in management of emergent depression while maintaining the blinded treatment assignment. This will permit the comparison of prophylactic versus therapeutic use of citalopram. The primary outcome is the average proportion of prescribed PEG-IFN-alpha and ribavirin doses taken per month at weeks 12 and 24, and will be compared between treatment arms. The study will also compare the development of moderate-to-severe depression between treatment arms. A unique feature of this trial will be the use of Telepsychiatry to standardize observer-administered neuropsychiatric evaluations. Assessments of anxiety, quality of life, and adherence to therapy, as well as pathogenetic studies of neuropsychiatric side effects, will be conducted. Intention-to-treat analyses using random regression modeling will be employed to analyze longitudinal data on prescribed PEG-IFN-alpha and ribavirin doses. Survival analyses will be used to compare the time to the development of depression between the two arms. Effective prevention of a broad range of neuropsychiatric symptoms by citalopram has the potential to diminish PEG-IFN-alpha associated morbidity and consequently, allow a greater number of patients to complete full therapy.

Effects of a dietary Aspergillus oryzae extract containing alpha-amylase activity on performance and carcass characteristics of finishing beef cattle.

PubMed

Tricarico, J M; Abney, M D; Galyean, M L; Rivera, J D; Hanson, K C; McLeod, K R; Harmon, D L

2007-03-01

Three experiments were conducted to examine the effects of an Aspergillus oryzae extract containing alpha-amylase activity on performance and carcass characteristics of finishing beef cattle. In Exp. 1, 120 crossbred steers were used in a randomized complete block design to evaluate the effects of roughage source (alfalfa hay vs. cottonseed hulls) and supplemental alpha-amylase at 950 dextrinizing units (DU)/kg of DM. Significant roughage source x alpha-amylase interactions (P < 0.05) were observed for performance. In steers fed cottonseed hulls, supplemental alpha-amylase increased ADG through d 28 and 112 and tended (P < 0.15) to increase ADG in all other periods. The increases in ADG were related to increased DMI and efficiency of gain during the initial 28-d period but were primarily related to increased DMI as the feeding period progressed. Supplemental alpha-amylase increased (P = 0.02) the LM area across both roughage sources. In Exp. 2, 96 crossbred heifers were used in a randomized complete block design with a 2 x 3 factorial arrangement of treatments to evaluate the effects of corn processing (dry cracked vs. high moisture) and supplemental alpha-amylase concentration (0, 580, or 1,160 DU/kg of DM). Alpha-amylase supplementation increased DMI (P = 0.05) and ADG (P = 0.03) during the initial 28 d on feed and carcass-adjusted ADG (P = 0.04) across corn processing methods. Longissimus muscle area was greatest (quadratic effect, P = 0.04), and yield grade was least (quadratic effect, P = 0.02) in heifers fed 580 DU of alpha-amylase/kg of DM across corn processing methods. In Exp. 3, 56 crossbred steers were used in a randomized complete block design to evaluate the effects of supplemental alpha-amylase (930 DU/kg of DM) on performance when DMI was restricted to yield a programmed ADG. Alpha-amylase supplementation did not affect performance when DMI was restricted. We conclude that dietary alpha-amylase supplementation of finishing beef diets may result in increased ADG through increased DMI under certain dietary conditions and that further research is warranted to explain its mode of action and interactions with dietary ingredients.

Design, objectives, execution and reporting of published open-label extension studies.

PubMed

Megan, Bowers; Pickering, Ruth M; Weatherall, Mark

2012-04-01

Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity. © 2010 Blackwell Publishing Ltd.

First Step in Telehealth Assessment: A Randomized Controlled Trial to Investigate the Effectiveness of an Electronic Case History Form for Dysphagia.

PubMed

Kantarcigil, Cagla; Malandraki, Georgia A

2017-08-01

The need for developing effective telehealth tools for dysphagia management is high not only for people who live in rural areas, but also for individuals with mobility/access limitations. We aimed to develop an electronic case History Tool/form (thereafter, e-HiT) for dysphagia, and compare its effectiveness with its paper-based version (PBV) on completion time, completeness, independence, and patient perceptions/satisfaction. Secondarily, we examined associations between the aforementioned variables and predictor variables, such as age, cognition, and computer/internet use. Forty adults who expressed concerns with eating/swallowing participated. To compare both versions, a randomized, controlled two-period crossover design was used. In Visit 1, Group A completed the e-HiT and Group B completed the PBV. In Visit 2, Group A completed the PBV and Group B completed the e-HiT. A satisfaction survey was completed post visits. There were no statistically significant differences for completion time (p = 0.743), completeness (p = 0.486), and independence (p = 0.738). Patient perception/satisfaction was significantly higher with the e-HiT (p = 0.004). In addition, a significant association was found between completion time and age (p = 0.0063). Our results indicate that completing the e-HiT is as time efficient as completing the PBV and that both forms elicit the same amount of information with no or minimal support. Also, completion of the e-HiT yielded significantly higher satisfaction responses. This is the first study documenting the effectiveness of the e-HiT for outpatients with dysphagia, providing evidence that the first step of a swallowing assessment-case history completion-can be effectively completed via telehealth by individuals with reliable internet connection and basic computer literacy skills.

Reliability of Videoconferencing Administration of a Communication Questionnaire to People With Traumatic Brain Injury and Their Close Others.

PubMed

Rietdijk, Rachael; Power, Emma; Brunner, Melissa; Togher, Leanne

To compare in-person with videoconferencing administration of a communication questionnaire for people with traumatic brain injury (TBI) and their close others. Repeated-measures design with randomized order of administration. Twenty adults with severe TBI and their close others. Both participants with TBI and their close others completed the La Trobe Communication Questionnaire (LCQ) via interview with a clinician, once via Skype and once during a home visit. Total LCQ score and time taken for completion. There were no significant differences between videoconferencing and in-person conditions in the total scores or time taken to complete the questionnaire. Videoconferencing-based administration of the LCQ is as reliable and efficient as in-person administration.

A Pilot Feasibility Intervention to Increase Advance Care Planning among African Americans in the Deep South.

PubMed

Huang, Chao-Hui Sylvia; Crowther, Martha; Allen, Rebecca S; DeCoster, Jamie; Kim, Giyeon; Azuero, Casey; Ang, Xinying; Kvale, Elizabeth

2016-02-01

Despite growing efforts to facilitate advance care planning (ACP) to decrease health disparities in palliative care, low completion rates of advance directives (AD) have been consistently found among African Americans. The objective was to examine the feasibility of a multicomponent ACP intervention program that integrates motivational interviewing, evidence-based ACP facilitation program (Respecting Choices(®)), and health-literacy adjusted AD. This pilot study aims to address the unique barriers to ACP engagement among African Americans in the Deep South. The design was a mixed-method randomized controlled trial design. Analysis of covariance (ANCOVA) and thematic content analysis (TCA) were conducted to identify barriers and facilitators for ACP engagement and to assess feasibility, knowledge, and intention to complete an AD. Thirty community-dwelling African Americans (mean age M = 55.43, SD = 6.71, range = 47-73) were recruited from the Deep South and randomly assigned to receive intervention (n = 15) or educational material (n = 15) at a local university medical center. All participants (n = 30) reported high satisfaction (M = 4.81, SD = 0.44, max score = 5) and increased intent to complete an AD at postintervention. A significant increase in knowledge on AD from baseline to postintervention was observed in the intervention group-t(14) = -3.06, p = 0.01, d = 1.67); no significant change was found for control. Lack of information, mistrust of doctors, and avoidance of discussing death were primary barriers to ACP discussions. Facilitators include ACP education, decreased mistrust, and proactive initiation of ongoing ACP discussions. Feasibility data revealed successful implementation of a brief intervention to increase ACP engagement and willingness to complete an AD among southern African Americans.

Contrast fluoroscopic evaluation of gastrointestinal transit times with and without the use of falconry hoods in red-tailed hawks (Buteo jamaicensis).

PubMed

Doss, Grayson A; Williams, Jackie M; Mans, Christoph

2017-11-01

OBJECTIVE To evaluate gastrointestinal transit times in red-tailed hawks (Buteo jamaicensis) by use of contrast fluoroscopic imaging and investigate the effect of falconry hooding in these hawks on gastrointestinal transit time. DESIGN Prospective, randomized, blinded, complete crossover study. ANIMALS 9 healthy red-tailed hawks. PROCEDURES Hawks were gavage-fed a 30% weight-by-volume barium suspension (25 mL/kg [11.3 mL/lb]) into the crop. Fluoroscopic images were obtained at multiple time points after barium administration. Time to filling and emptying of various gastrointestinal tract organs and overall transit time were measured. The effect of hooding (hooded vs nonhooded) on these variables was assessed in a randomized complete crossover design. RESULTS In nonhooded birds, overall gastrointestinal transit time ranged from 30 to 180 minutes (mean ± SD, 100 ± 52 min). Time to complete crop emptying ranged from 30 to 180 minutes (83 ± 49 min). Contrast medium was present in the ventriculus in all birds within 5 minutes of administration and in the small intestines within 5 to 15 minutes (median, 5 min). Hooding of red-tailed hawks resulted in a significant delay of complete crop emptying (no hood, 83 ± 49 minutes; hood, 133 ± 48 minutes), but no significant effects of hooding were found on other measured variables. CONCLUSIONS AND CLINICAL RELEVANCE These results indicated that overall gastrointestinal transit times are faster in red-tailed hawks than has been reported for psittacines and that the use of a falconry hood in red-tailed hawks may result in delayed crop emptying. Hooding did not exert significant effects on overall gastrointestinal transit time in this raptorial species.

Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention

PubMed Central

2012-01-01

Background Multiple sclerosis (MS) is a complex, chronic and progressive disease and rehabilitation services can provide important support to patients. Few MS rehabilitation programs have been shown to provide health improvements to patients in a cost-effective manner. The objective of this study is to assess the effects in terms of changes measured by a variety of standardized quality of life, mastery, coping, compliance and individual goal-related endpoints. This combination provides the basis for analyzing the complexity of MS and outcomes of a personalized rehabilitation. Methods/Design Patients with MS referred to hospital rehabilitation services will be randomized to either early admission (within two months) or usual admission (after an average waiting time of eight months). They will complete a battery of standardized health outcome instruments prior to randomization, and again six and twelve months after randomization, and a battery of goal-related outcome measures at admission and discharge, and again one, six and twelve months after randomization. Discussion The results of the study are expected to contribute to further development of MS rehabilitation services and to discussions about the design and content of such services. The results will also provide additional information to health authorities responsible for providing and financing rehabilitation services. Trial registration Current Controlled Trials (ISRCTN05245917) PMID:22954027

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

Effect of treated tannery effluent with domestic wastewater and amendments on growth and yield of cotton.

PubMed

Jagathjothi, N; Amanullah, M Mohamed; Muthukrishnan, P

2013-11-15

Pot culture and field experiments were carried out at the Common Effluent Treatment Plant (CETP), Dindigul during kharif 2011-12 to investigate the influence of irrigation of treated tannery effluent along with domestic wastewater on growth, yield attributes and yield of cotton. The pot culture was in a factorial completely randomized design and field experiment laid out in factorial randomized block design with four replications. The results revealed that the mixing proportion of 25% Treated Tannery Effluent (TTE)+75% domestic wastewater (DWW) application recorded taller plants, higher dry matter production, number of sympodial branches plant(-1), number of fruiting points plant(-1), number of bolls plant(-1) and seed cotton yield with yield reduction of 15.28 and 16.11% compared to normal water irrigation under pot culture and field experiment, respectively. Regarding amendments, gypsum application registered higher seed cotton yield followed by VAM.

The Analysis of Completely Randomized Factorial Experiments When Observations Are Lost at Random.

ERIC Educational Resources Information Center

Hummel, Thomas J.

An investigation was conducted of the characteristics of two estimation procedures and corresponding test statistics used in the analysis of completely randomized factorial experiments when observations are lost at random. For one estimator, contrast coefficients for cell means did not involve the cell frequencies. For the other, contrast…

Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials.

PubMed

Dinglas, Victor D; Huang, Minxuan; Sepulveda, Kristin A; Pinedo, Mariela; Hopkins, Ramona O; Colantuoni, Elizabeth; Needham, Dale M

2015-01-09

Effective strategies for contacting and recruiting study participants are critical in conducting clinical research. In this study, we conducted two sequential randomized controlled trials of mail- and telephone-based strategies for contacting and recruiting participants, and evaluated participant-related variables' association with time to survey completion and survey completion rates. Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical, cognitive and mental health outcomes, with their last study visit completed at a median of 34 months previously. Eligible subjects were contacted to complete a new research survey as part of two randomized trials, initially using a randomized mail-based contact strategy, followed by a randomized telephone-based contact strategy for non-responders to the mail strategy. Both strategies focused on using either a personalized versus a generic approach. In addition, 18 potentially relevant subject-related variables (e.g., demographics, last known physical and mental health status) were evaluated for association with time to survey completion. Of 308 eligible subjects, 67% completed the survey with a median (IQR) of 3 (2, 5) contact attempts required. There was no significant difference in the time to survey completion for either randomized trial of mail- or phone-based contact strategy. Among all subject-related variables, age ≤40 years and minority race were independently associated with a longer time to survey completion. We found that age ≤40 years and minority race were associated with a longer time to survey completion, but personalized versus generic approaches to mail- and telephone-based contact strategies had no significant effect. Repeating both mail and telephone contact attempts was important for increasing survey completion rate. NCT00719446.

Optimizing the Scientific Yield from a Randomized Controlled Trial (RCT): Evaluating Two Behavioral Interventions and Assessment Reactivity with a Single Trial

PubMed Central

Carey, Michael P.; Senn, Theresa E.; Coury-Doniger, Patricia; Urban, Marguerite A.; Vanable, Peter A.; Carey, Kate B.

2013-01-01

Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. PMID:23816489

Random sampling of elementary flux modes in large-scale metabolic networks.

PubMed

Machado, Daniel; Soons, Zita; Patil, Kiran Raosaheb; Ferreira, Eugénio C; Rocha, Isabel

2012-09-15

The description of a metabolic network in terms of elementary (flux) modes (EMs) provides an important framework for metabolic pathway analysis. However, their application to large networks has been hampered by the combinatorial explosion in the number of modes. In this work, we develop a method for generating random samples of EMs without computing the whole set. Our algorithm is an adaptation of the canonical basis approach, where we add an additional filtering step which, at each iteration, selects a random subset of the new combinations of modes. In order to obtain an unbiased sample, all candidates are assigned the same probability of getting selected. This approach avoids the exponential growth of the number of modes during computation, thus generating a random sample of the complete set of EMs within reasonable time. We generated samples of different sizes for a metabolic network of Escherichia coli, and observed that they preserve several properties of the full EM set. It is also shown that EM sampling can be used for rational strain design. A well distributed sample, that is representative of the complete set of EMs, should be suitable to most EM-based methods for analysis and optimization of metabolic networks. Source code for a cross-platform implementation in Python is freely available at http://code.google.com/p/emsampler. dmachado@deb.uminho.pt Supplementary data are available at Bioinformatics online.

The Effects of Using Animations on Sixth Grade Students' Academic Success in Turkish Grammar Learning

ERIC Educational Resources Information Center

Gün, Mesut

2016-01-01

The purpose of this empirical study is to determine how and to what extent the use of animations impacts auditory acquisition, one of the key learning fields in 6th grade grammar, as measured by students' academic success and completion rates. By using a pre-test and post-test design, this empirical study randomly divided a group of Turkish 6th…

Short-term effects of silviculture on breeding birds in William B. Bankhead National Forest

Treesearch

Jill M. Wick; Yong Wang; Callie Jo Schweitzer

2013-01-01

We evaluated the changes in the bird community in relation to six disturbance treatments in the William B. Bankhead National Forest, AL. The study design is randomized complete block with a factorial arrangement of three thinning levels [no thin, 11 m²/ha residual basal area (BA), and 17 m²/ha residual BA] and two burn treatments (burn and no burn),...

Short-term effects of seasonal prescribed burning on the ectomycorrhizal fungal community and fine root biomass in ponderosa pine stands in the Blue Mountains of Oregon.

Treesearch

J.E. Smith; D. McKay; C.G. Niwa; W.G. Thies; G. Brenner; J.W. Spatafora

2004-01-01

The effects of seasonal prescribed fire on the belowground ectomycorrhizal community and live fine root biomass were investigated before, 1 year after, and 2 years after prescribed underburning. Ectomycorrhizas were sampled from four replications of three treatments (fall underburning, spring underburning, and a nonburned.control) in a randomized complete block design...

Size of Coarse Woody Debris 5 Years After Girdling and Removal Treatments in 50-Year-Old Loblolly Pine Plantations

Treesearch

M. Boyd Edwards

2004-01-01

In 1996, a study began at Savannah River Site to investigate large-scale replicated forest areas to control coarse woody debris for integrated biodiversity objectives. Research design was a randomized complete block with four treatments replicated in four blocks, resulting in 16 plots. The treatments applied to 50-year-old loblolly pine stands were (1) control, (2)...

Preplanting Treatments and Natural Invasion of Tree Species Onto Former Agricultural Fields at the Tensas River National Wildlife Refuge, Louisiana

Treesearch

John W. McCoy; Bobby D. Keeland; Brian Roy Lockhart; Thomas Dean

2002-01-01

As part of a study of oak planting techniques for bottomland hardwood afforestation we examined the natural invasion of woody species onto former agricultural fields at Tensas River National Wildlife Refuge. Three replications of 14 treatments were established as 0.4 hectare (1 acre) plots in a complete randomized block design. Combinations of these treatments were...

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

Predictors of study completion and withdrawal in a randomized clinical trial of a pediatric diabetes adherence intervention.

PubMed

Driscoll, Kimberly A; Killian, Michael; Johnson, Suzanne Bennett; Silverstein, Janet H; Deeb, Larry C

2009-05-01

Loss of participants in randomized clinical trials threatens the validity of study findings. The purpose of this study was to determine pre-randomization predictors of study completion status throughout the course of a randomized clinical trial involving young children with type 1 diabetes and their primary caregivers. An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child's regular 3-month diabetes clinic visit. The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group. Among those who completed the study and regardless of treatment group, participants were categorized into two groups: On-Time Completers (n=41) and Late Completers (n=39). Demographic, disease, and psychosocial characteristics of children and their primary caregivers measured prior to study randomization were tested for their association with the participants' completion status (i.e., On-Time Completers, Late Completers, or Withdrawals). Of the 108 participants, 28 (25.9%) withdrew and 80 (74.1%) completed the study. On-Time Completers (i.e., study completed within 4 months of expected date) were more likely to have private insurance and primary caregivers with some college education. Late Completers (i.e., study completion took longer than 4 months) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression. Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home. Pre-randomization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence, permitting the investigators to develop retention strategies aimed at this high-risk group.

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome.

PubMed

Leigh, Mary Jacena S; Nguyen, Danh V; Mu, Yi; Winarni, Tri I; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M; Hessl, David; Hagerman, Randi J

2013-04-01

Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Previous open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, aged 3.5 years to 16 years (n = 55, mean age 9.2 [SD, 3.6] years). Participants were randomized to minocycline or placebo for 3 months and then switched to the other treatment. Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared with placebo (2.49 ± 0.13 and 2.97 ± 0.13, respectively, p = .0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analog Scale (minocycline: 5.26 cm ± 0.46 cm, placebo: 4.05 cm ± 0.46 cm; p = .0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding, and preliminary efficacy analysis results known to investigators. Minocycline treatment for 3 months in children with FXS resulted in greater global improvement than placebo. Treatment for 3 months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline.

STAR 3 randomized controlled trial to compare sensor-augmented insulin pump therapy with multiple daily injections in the treatment of type 1 diabetes: research design, methods, and baseline characteristics of enrolled subjects.

PubMed

Davis, Stephen N; Horton, Edward S; Battelino, Tadej; Rubin, Richard R; Schulman, Kevin A; Tamborlane, William V

2010-04-01

Sensor-augmented pump therapy (SAPT) integrates real-time continuous glucose monitoring (RT-CGM) with continuous subcutaneous insulin infusion (CSII) and offers an alternative to multiple daily injections (MDI). Previous studies provide evidence that SAPT may improve clinical outcomes among people with type 1 diabetes. Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 is a multicenter randomized controlled trial comparing the efficacy of SAPT to that of MDI in subjects with type 1 diabetes. Subjects were randomized to either continue with MDI or transition to SAPT for 1 year. Subjects in the MDI cohort were allowed to transition to SAPT for 6 months after completion of the study. SAPT subjects who completed the study were also allowed to continue for 6 months. The primary end point was the difference between treatment groups in change in hemoglobin A1c (HbA1c) percentage from baseline to 1 year of treatment. Secondary end points included percentage of subjects with HbA1c < or =7% and without severe hypoglycemia, as well as area under the curve of time spent in normal glycemic ranges. Tertiary end points include percentage of subjects with HbA1c < or =7%, key safety end points, user satisfaction, and responses on standardized assessments. A total of 495 subjects were enrolled, and the baseline characteristics similar between the SAPT and MDI groups. Study completion is anticipated in June 2010. Results of this randomized controlled trial should help establish whether an integrated RT-CGM and CSII system benefits patients with type 1 diabetes more than MDI.

A Randomized Double-Blind, Placebo-Controlled Trial of Minocycline in Children and Adolescents with Fragile X Syndrome

PubMed Central

Leigh, Mary Jacena S.; Nguyen, Danh V.; Mu, Yi; Winarni, Tri I.; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M.; Hessl, David; Hagerman, Randi J.

2013-01-01

Objective Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Prior open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Method Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, ages 3.5-16 years (n=55, mean age 9.2 (SD 3.6 years)). Participants were randomized to minocycline or placebo for three months, then switched to the other treatment. Results Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared to placebo (2.49 ±0.13, 2.97 ±0.13, respectively, p 0.0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analoge Scale (minocycline 5.26 cm ±0.46 cm, placebo 4.05 cm±0.46cm; p 0.0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators. Conclusion Minocycline treatment for three months in children with FXS resulted in greater global improvement than placebo. Treatment for three months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline. PMID:23572165

Telephone follow-up to a mail survey: when to offer an interview compared to a reminder call.

PubMed

Ziegenfuss, Jeanette Y; Burmeister, Kelly R; Harris, Ann; Holubar, Stefan D; Beebe, Timothy J

2012-03-20

Using a different mode of contact on the final follow-up to survey non-respondents is an identified strategy to increase response rates. This study was designed to determine if a reminder phone call or a phone interview as a final mode of contact to a mailed survey works better to increase response rates and which strategy is more cost effective. A randomized study was embedded within a survey study of individuals treated with ulcerative colitis conducted in March 2009 in Olmsted County, Minnesota. After two mail contacts, non-respondents were randomly assigned to either a reminder telephone call or a telephone interview. Average cost per completed interview and response rates were compared between the two experimental conditions. The response rate in the reminder group and the interview did not differ where we considered both a completed survey and a signed form a complete (24% vs. 29%, p = 0.08). However, if such a signed form was not required, there was a substantial advantage to completing the interview over the phone (24% vs. 43%, p < 0.0001). The reminder group on average cost $27.00 per completed survey, while the interview group on average cost $53.00 per completed survey when a signed form was required and $36.00 per complete when a signed form was not required. The additional cost of completing an interview is worth it when an additional signed form is not required of the respondent. However, when such a signed form is required, offering an interview instead of a reminder phone call as a follow up to non-respondents does not increase response rates enough to outweigh the additional costs.

Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial.

PubMed

Goodkind, Jessica R; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian L; Baca, Brandon; Ndayisenga, Martin; Greene, R Neil; Shantzek, Cece

2017-02-01

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their feasibility and acceptability. In the current mixed-methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African, and Iraqi refugee adults and to engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013 and 2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, and postintervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community-academic partnerships engaged in RCTs.

CHALLENGES AND INNOVATIONS IN A COMMUNITY-BASED PARTICIPATORY RANDOMIZED CONTROLLED TRIAL

PubMed Central

Goodkind, Jessica R.; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian; Baca, Brandon; Ndaysenga, Martin; Greene, R. Neil; Shantzek, Cece

2016-01-01

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants’ intervention experiences, and their feasibility and acceptability. In the current mixed methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African and Iraqi refugee adults and engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013-2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, post-intervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community-academic partnerships engaged in RCTs. PMID:27179291

Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial.

PubMed

Pinheiro, Marina B; Ho, Kevin K; Ferreira, Manuela L; Refshauge, Kathryn M; Grunstein, Ron; Hopper, John L; Maher, Christopher G; Koes, Bart W; Ordoñana, Juan R; Ferreira, Paulo H

2016-10-01

Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months' follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial.

Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial.

PubMed

Johal, Ama; Haria, Priya; Manek, Seema; Joury, Easter; Riha, Renata

2017-02-15

To compare the effectiveness of a custom-made (MRDc) versus ready-made (MRDr) mandibular repositioning devices (MRD) in the management of obstructive sleep apnea (OSA). A randomized crossover trial design was adopted in which patients with a confirmed diagnosis of OSA were randomly allocated to receive either a 3-month period of ready-made or custom-made MRD, with an intervening washout period of 2 weeks, prior to crossover. Treatment outcomes included both objective sleep monitoring and patient-centered measures (daytime sleepiness, partner snoring and quality of life). Twenty-five patients, with a mild degree of OSA (apnea-hypopnea index of 13.3 [10.9-25] events/h) and daytime sleepiness (Epworth Sleepiness Scale of 11 [6-16]), completed both arms of the trial. The MRDc achieved a complete treatment response in 64% of participants, compared with 24% with the MRDr (p < 0.001). A significant difference was observed in treatment failures, when comparing the MRDr (36%) with the MRDc (4%). Excessive daytime sleepiness (Epworth Sleepiness Scale ≥ 10) persisted in 33% (MRDc) and 66% (MRDr) of OSA subjects, following treatment. A statistically significant improvement was observed in quality of life scales following MRDc therapy only. Significant differences were observed in relation to both the number of nights per week (p = 0.004) and hours per night (p = 0.006) between the two different designs of device. The study demonstrates the significant clinical effectiveness of a custom-made mandibular repositioning device, particularly in terms of patient compliance and tolerance, in the treatment of OSA. © 2017 American Academy of Sleep Medicine

“Fair Play”: A Videogame Designed to Address Implicit Race Bias Through Active Perspective Taking

PubMed Central

Kaatz, Anna; Chu, Sarah; Ramirez, Dennis; Samson-Samuel, Clem; Carnes, Molly

2014-01-01

Abstract Objective: Having diverse faculty in academic health centers will help diversify the healthcare workforce and reduce health disparities. Implicit race bias is one factor that contributes to the underrepresentation of Black faculty. We designed the videogame “Fair Play” in which players assume the role of a Black graduate student named Jamal Davis. As Jamal, players experience subtle race bias while completing “quests” to obtain a science degree. We hypothesized that participants randomly assigned to play the game would have greater empathy for Jamal and lower implicit race bias than participants randomized to read narrative text describing Jamal's experience. Materials and Methods: University of Wisconsin–Madison graduate students were recruited via e-mail and randomly assigned to play “Fair Play” or read narrative text through an online link. Upon completion, participants took an Implicit Association Test to measure implicit bias and answered survey questions assessing empathy toward Jamal and awareness of bias. Results: As hypothesized, gameplayers showed the least implicit bias but only when they also showed high empathy for Jamal (P=0.013). Gameplayers did not show greater empathy than text readers, and women in the text condition reported the greatest empathy for Jamal (P=0.008). However, high empathy only predicted lower levels of implicit bias among those who actively took Jamal's perspective through gameplay (P=0.014). Conclusions: A videogame in which players experience subtle race bias as a Black graduate student has the potential to reduce implicit bias, possibly because of a game's ability to foster empathy through active perspective taking. PMID:26192644

Compassion meditation enhances empathic accuracy and related neural activity

PubMed Central

Mascaro, Jennifer S.; Rilling, James K.; Tenzin Negi, Lobsang; Raison, Charles L.

2013-01-01

The ability to accurately infer others’ mental states from facial expressions is important for optimal social functioning and is fundamentally impaired in social cognitive disorders such as autism. While pharmacologic interventions have shown promise for enhancing empathic accuracy, little is known about the effects of behavioral interventions on empathic accuracy and related brain activity. This study employed a randomized, controlled and longitudinal design to investigate the effect of a secularized analytical compassion meditation program, cognitive-based compassion training (CBCT), on empathic accuracy. Twenty-one healthy participants received functional MRI scans while completing an empathic accuracy task, the Reading the Mind in the Eyes Test (RMET), both prior to and after completion of either CBCT or a health discussion control group. Upon completion of the study interventions, participants randomized to CBCT and were significantly more likely than control subjects to have increased scores on the RMET and increased neural activity in the inferior frontal gyrus (IFG) and dorsomedial prefrontal cortex (dmPFC). Moreover, changes in dmPFC and IFG activity from baseline to the post-intervention assessment were associated with changes in empathic accuracy. These findings suggest that CBCT may hold promise as a behavioral intervention for enhancing empathic accuracy and the neurobiology supporting it. PMID:22956676

Lessons learned: a pilot study on occupational therapy effectiveness for children with sensory modulation disorder.

PubMed

Miller, Lucy Jane; Schoen, Sarah A; James, Katherine; Schaaf, Roseann C

2007-01-01

The purpose of this pilot study was to prepare for a randomized controlled study of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) with children who have sensory processing disorders (SPD). A one-group pretest, posttest design with 30 children was completed with a subset of children with SPD, those with sensory modulation disorder. Lessons learned relate to (a) identifying a homogeneous sample with quantifiable inclusion criteria, (b) developing an intervention manual for study replication and a fidelity to treatment measure, (c) determining which outcomes are sensitive to change and relate to parents' priorities, and (d) clarifying rigorous methodologies (e.g., blinded examiners, randomization, power). A comprehensive program of research is needed, including multiple pilot studies to develop enough knowledge that high-quality effectiveness research in occupational therapy can be completed. Previous effectiveness studies in OT-SI have been single projects not based on a unified long-term program of research.

The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment.

PubMed

Ockhuijsen, Henrietta D L; van den Hoogen, Agnes; Macklon, Nickolas S; Boivin, Jacky

2013-09-03

Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle. In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During recruitment for the RCT it was decided to add a fourth non-randomized group, a PRCI Control group that received the PRCI and completed the questionnaires but did not complete daily monitoring. Positive reappraisal is one of the few ways of coping that has been shown to be associated with increased wellbeing during unpredictable and uncontrollable situations like medical waiting periods. A simple evidence based self-help intervention could facilitate coping during this common medical situation. This RCT study will evaluate the value of a self-help coping intervention designed for medical waiting periods in women undergoing fertility treatment. The study is registered at the Clinical Tials.gov (NCT01701011).

Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

PubMed

Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

2010-11-30

Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be evaluated. Potential moderation by pre- and post-illness lifestyle, health and exercise-related attitudes, beliefs and motivation will also be assessed. Finally, the cost-effectiveness of both exercise interventions will be evaluated. This randomized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy, aiming to contribute to evidence-based practice in cancer rehabilitation programmes. This study is registered at the Netherlands Trial Register (NTR2153).

Incentive and Reminder Strategies to Improve Response Rate for Internet-Based Physician Surveys: A Randomized Experiment

PubMed Central

Wittich, Christopher M; Daniels, Wendlyn L; West, Colin P; Harris, Ann M; Beebe, Timothy J

2016-01-01

Background Most research on how to enhance response rates in physician surveys has been done using paper surveys. Uncertainties remain regarding how to enhance response rates in Internet-based surveys. Objective To evaluate the impact of a low-cost nonmonetary incentive and paper mail reminders (formal letter and postcard) on response rates in Internet-based physician surveys. Methods We executed a factorial-design randomized experiment while conducting a nationally representative Internet-based physician survey. We invited 3966 physicians (randomly selected from a commercial database of all licensed US physicians) via email to complete an Internet-based survey. We used 2 randomly assigned email messages: one message offered a book upon survey completion, whereas the other did not mention the book but was otherwise identical. All nonrespondents received several email reminders. Some physicians were further assigned at random to receive 1 reminder via paper mail (either a postcard or a letter) or no paper reminder. The primary outcome of this study was the survey response rate. Results Of the 3966 physicians who were invited, 451 (11.4%) responded to at least one survey question and 336 (8.5%) completed the entire survey. Of those who were offered a book, 345/2973 (11.6%) responded compared with 106/993 (10.7%) who were not offered a book (odds ratio 1.10, 95% CI 0.87-1.38, P=.42). Regarding the paper mail reminder, 168/1572 (10.7%) letter recipients, 148/1561 (9.5%) postcard recipients, and 69/767 (9.0%) email-only recipients responded (P=.35). The response rate for those receiving letters or postcards was similar (odds ratio 1.14, 95% CI 0.91-1.44, P=.26). Conclusions Offering a modest nonmonetary incentive and sending a paper reminder did not improve survey response rate. Further research on how to enhance response rates in Internet-based physician surveys is needed. PMID:27637296

Incentive and Reminder Strategies to Improve Response Rate for Internet-Based Physician Surveys: A Randomized Experiment.

PubMed

Cook, David A; Wittich, Christopher M; Daniels, Wendlyn L; West, Colin P; Harris, Ann M; Beebe, Timothy J

2016-09-16

Most research on how to enhance response rates in physician surveys has been done using paper surveys. Uncertainties remain regarding how to enhance response rates in Internet-based surveys. To evaluate the impact of a low-cost nonmonetary incentive and paper mail reminders (formal letter and postcard) on response rates in Internet-based physician surveys. We executed a factorial-design randomized experiment while conducting a nationally representative Internet-based physician survey. We invited 3966 physicians (randomly selected from a commercial database of all licensed US physicians) via email to complete an Internet-based survey. We used 2 randomly assigned email messages: one message offered a book upon survey completion, whereas the other did not mention the book but was otherwise identical. All nonrespondents received several email reminders. Some physicians were further assigned at random to receive 1 reminder via paper mail (either a postcard or a letter) or no paper reminder. The primary outcome of this study was the survey response rate. Of the 3966 physicians who were invited, 451 (11.4%) responded to at least one survey question and 336 (8.5%) completed the entire survey. Of those who were offered a book, 345/2973 (11.6%) responded compared with 106/993 (10.7%) who were not offered a book (odds ratio 1.10, 95% CI 0.87-1.38, P=.42). Regarding the paper mail reminder, 168/1572 (10.7%) letter recipients, 148/1561 (9.5%) postcard recipients, and 69/767 (9.0%) email-only recipients responded (P=.35). The response rate for those receiving letters or postcards was similar (odds ratio 1.14, 95% CI 0.91-1.44, P=.26). Offering a modest nonmonetary incentive and sending a paper reminder did not improve survey response rate. Further research on how to enhance response rates in Internet-based physician surveys is needed.

A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening among Latino Immigrants in a Primary Care Facility

PubMed Central

Schwartz, Mark D.; Shah, Nirav R.; Gany, Francesca M.

2010-01-01

BACKGROUND Latino immigrants face a higher burden of colorectal cancer (CRC) and screening rates are low. OBJECTIVE To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants. DESIGN A randomized controlled trial, with randomization at the physician level. PARTICIPANTS Pairs of 65 primary care physicians and 65 Latino immigrant patients participated, 31 in the intervention and 34 in the control group. INTERVENTION CRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient, and a patient-delivered paper-based reminder for their physician. MEASUREMENTS Completed CRC screening, physician recommendation for CRC screening, and patient adherence to physician recommended CRC screening. RESULTS The overall rate of completed screening for CRC was 55% for the intervention and 18% for the control group (p = 0.002). Physicians recommended CRC screening for 61% of patients in the intervention group versus 41% in the control group (p = 0.08). Of those that received a recommendation, 90% in the intervention group adhered to it versus 26% in the control group (p = 0.007). CONCLUSIONS The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended. Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening, while employing effective patient adherence interventions. PMID:20213208

Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial.

PubMed

Tronieri, Jena Shaw; Alfaris, Nasreen; Chao, Ariana M; Pearl, Rebecca L; Alamuddin, Naji; Bakizada, Zayna M; Berkowitz, Robert I; Wadden, Thomas A

2017-08-01

Few studies have examined the efficacy of recently approved medications for chronic weight management in facilitating the maintenance of lost weight. This paper provides an overview of the design and rationale for a trial investigating whether lorcaserin, when combined with behavioral weight loss maintenance sessions (WLM), will facilitate the maintenance of losses of ≥5% of initial weight. In this two-phase trial, participants with obesity will enroll in a 14-week run-in diet program consisting of weekly group lifestyle modification sessions and a 1000-1200kcal/d meal replacement diet. Participants who complete this weight induction phase and lose at least 5% of initial weight will then be randomized to 52weeks of WLM plus lorcaserin or WLM plus placebo. We hypothesize that at 52weeks post randomization, participants assigned to WLM plus lorcaserin will achieve significantly better maintenance of the prior 5% weight loss. We will recruit 182 adults with obesity to participate in the diet run-in, 136 of whom (75%) are expected to become eligible for the randomized controlled trial. Co-primary outcomes include the percentage of participants who maintain a loss of at least 5% of initial weight at week 52 and change in weight (kg) from randomization to week 52. This two-phase design will allow us to determine the potential efficacy of chronic weight management using lorcaserin for maintaining initial losses of at least 5% body weight, induced by the use of a structured meal-replacement diet. This combined approach holds promise of achieving larger long-term weight losses. NCT02388568 on ClinicalTrials.gov. Copyright © 2017 Elsevier Inc. All rights reserved.

Systems of support to increase colorectal cancer screening and follow-up rates (SOS): design, challenges, and baseline characteristics of trial participants.

PubMed

Green, Beverly B; Wang, C Y; Horner, Kathryn; Catz, Sheryl; Meenan, Richard T; Vernon, Sally W; Carrell, David; Chubak, Jessica; Ko, Cynthia; Laing, Sharon; Bogart, Andy

2010-11-01

Screening decreases colorectal cancer (CRC) morbidity and mortality, yet remains underutilized. Screening breakdowns arise from lack of uptake and failure to follow-up after a positive screening test. Systems of support to increase colorectal cancer screening and follow-up (SOS) is a randomized trial designed to increase: (1) CRC screening and (2) follow-up of positive screening tests. The Chronic Care Model and the Preventive Health Model inform study design. The setting is a large nonprofit healthcare organization. In part-1 study, patients age 50-75 due for CRC screening are randomized to one of 4 study conditions. Arm 1 receives usual care. Arm 2 receives automated support (mailed information about screening choices and fecal occult blood tests (FOBT)). Arm 3 receives automated and assisted support (a medical assistant telephone call). Arm 4 receives automated, assisted, and care management support (a registered nurse provides behavioral activation and coordination of care). In part-2, study patients with a positive FOBT or adenomas on flexible sigmoidoscopy are randomized to receive either usual care or nurse care management. Primary outcomes are: 1) the proportion with CRC screening, 2) the proportion with a complete diagnostic evaluation after a positive screening test. We sent recruitment letters to 15,414 patients and 4675 were randomized. Randomly assigned treatment groups were similar in age, sex, race, education, self-reported health, and CRC screening history. We will determine the effectiveness and cost effectiveness of stepped increases in systems of support to increase CRC screening and follow-up after a positive screening test over 2years. Copyright © 2010 Elsevier Inc. All rights reserved.

Evaluating the parent-adolescent communication toolkit: Usability and preliminary content effectiveness of an online intervention.

PubMed

Toombs, Elaine; Unruh, Anita; McGrath, Patrick

2018-01-01

This study aimed to assess the Parent-Adolescent Communication Toolkit, an online intervention designed to help improve parent communication with their adolescents. Participant preferences for two module delivery systems (sequential and unrestricted module access) were identified. Usability assessment of the PACT intervention was completed using pre-test and posttest comparisons. Usability data, including participant completion and satisfaction ratings were examined. Parents ( N  =   18) of adolescents were randomized to a sequential or unrestricted chapter access group. Parent participants completed pre-test measures, the PACT intervention and posttest measures. Participants provided feedback for the intervention to improve modules and provided usability ratings. Adolescent pre- and posttest ratings were evaluated. Usability ratings were high and parent feedback was positive. The sequential module access groups rated the intervention content higher and completed more content than the unrestricted chapter access group, indicating support for the sequential access design. Parent mean posttest communication scores were significantly higher ( p  <   .05) than pre-test scores. No significant differences were detected for adolescent participants. Findings suggest that the Parent-Adolescent Communication Toolkit has potential to improve parent-adolescent communication but further effectiveness assessment is required.

Motivational and Skills Training HIV/STI Sexual Risk Reduction Groups for Men

PubMed Central

Calsyn, Donald A.; Hatch-Maillette, Mary; Tross, Susan; Doyle, Suzanne R.; Crits-Christoph, Paul; Song, Yong S.; Harrer, Judy M.; Lalos, Genise; Berns, Sara B.

2009-01-01

The effectiveness of a motivational and skills training HIV/AIDS group intervention designed for men in substance abuse treatment was evaluated. Men in methadone maintenance (n=288) or outpatient psychosocial treatment (n=302) completed assessments at baseline, 2 weeks, 3- and 6-months post intervention. Participants were randomly assigned to attend either “Real Men Are Safe” (REMAS; five sessions containing information, motivational exercises and skills training), or HIV education (HIV-Ed; one session containing HIV prevention information). REMAS participants engaged in significantly fewer unprotected vaginal and anal sexual intercourse occasions (USO) during the 90 days prior to the 3- and 6-month follow-ups than HIV-Ed participants. Completing REMAS resulted in an even stronger effect: completers reduced their number of USO by 21% from baseline to 6-month follow-up. In contrast, HIV-Ed completers increased the number of USO by 2%. A motivational and skills training HIV prevention intervention designed for men was associated with greater sexual risk reduction over standard HIV education. Substance abuse treatment programs can therefore help reduce sexual risk among their clientele by providing a more intensive intervention than what is traditionally provided. PMID:19150206

Factors associated with attrition from a randomized controlled trial of meaning-centered group psychotherapy for patients with advanced cancer

PubMed Central

Applebaum, Allison J.; Lichtenthal, Wendy G.; Pessin, Hayley A.; Radomski, Julia N.; Gökbayrak, N. Simay; Katz, Aviva M.; Rosenfeld, Barry; Breitbart, William

2013-01-01

Objective The generalizability of palliative care intervention research is often limited by high rates of study attrition. This study examined factors associated with attrition from a randomized controlled trial comparing meaning-centered group psychotherapy (MCGP), an intervention designed to help advanced cancer patients sustain or enhance their sense of meaning to the supportive group psychotherapy (SGP), a standardized support group. Methods Patients with advanced solid tumor cancers (n = 153) were randomized to eight sessions of either the MCGP or SGP. They completed assessments of psychosocial, spiritual, and physical well-being pretreatment, midtreatment, and 2 months post-treatment. Attrition was assessed in terms of the percent of participants who failed to complete these assessments, and demographic, psychiatric, medical, and study-related correlates of attrition were examined for the participants in each of these categories. Results The rates of attrition at these time points were 28.1%, 17.7%, and 11.1%, respectively; 43.1% of the participants (66 of 153) completed the entire study. The most common reason for dropout was patients feeling too ill. Attrition rates did not vary significantly between study arms. The participants who dropped out pretreatment reported less financial concerns than post-treatment dropouts, and the participants who dropped out of the study midtreatment had poorer physical health than treatment completers. There were no other significant associations between attrition and any demographic, medical, psychiatric, or study-related variables. Conclusions These findings highlight the challenge of maintaining advanced cancer patients in longitudinal research and suggest the need to consider alternative approaches (e.g., telemedicine) for patients who might benefit from group interventions but are too ill to travel. PMID:21751295

Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention.

PubMed

Thompson, Patricia; Roe, Denise J; Fales, Liane; Buckmeier, Julie; Wang, Fang; Hamilton, Stanley R; Bhattacharyya, Achyut; Green, Sylvan; Hsu, Chiu-Hsieh; Chow, H-H Sherry; Ahnen, Dennis J; Boland, C Richard; Heigh, Russell I; Fay, David E; Martinez, Maria Elena; Jacobs, Elizabeth; Ashbeck, Erin L; Alberts, David S; Lance, Peter

2012-12-01

COX inhibitors reduce colorectal adenoma recurrence by up to 45% and selenium supplementation may prevent colorectal cancer. Following colonoscopic adenoma resection, 1,600 men and women, ages 40 to 80 years, were randomized to celecoxib (400 mg daily), a selective COX-2 inhibitor, and/or selenium (200 μg daily as selenized yeast), or double placebo. The trial was initiated in November 2001. The primary trial endpoint is adenoma recurrence in each intervention group compared with placebo, as determined by surveillance colonoscopy conducted three to five years after baseline. Randomization was stratified by use of low-dose aspirin (81 mg) and clinic site. Following reports of cardiovascular toxicity associated with COX-2 inhibitors, the celecoxib arm was discontinued in December 2004 when 824 participants had been randomized. Accrual continued with randomization to selenium alone or placebo. Randomization of the originally planned cohort (n = 1,621) was completed in November 2008. A further 200 patients with one or more advanced adenomas (denoting increased risk for colorectal cancer) were accrued to enhance statistical power for determining intervention efficacy in this higher-risk subgroup. Accrual of the total cohort (n = 1,824) was completed in January 2011. Baseline cohort characteristics include: mean age 62.9 years; 65% male; body mass index (BMI) 29.1 ± 5.1; 47% taking low-dose aspirin while on trial; 20% with three or more adenomas; and 38% with advanced adenomas. Intervention effects on adenoma recurrence will be determined, and their modification by genetic background and baseline selenium level. The effect of selenium supplementation on risk for type II diabetes will also be reported. ©2012 AACR

The Skillings-Mack test (Friedman test when there are missing data).

PubMed

Chatfield, Mark; Mander, Adrian

2009-04-01

The Skillings-Mack statistic (Skillings and Mack, 1981, Technometrics 23: 171-177) is a general Friedman-type statistic that can be used in almost any block design with an arbitrary missing-data structure. The missing data can be either missing by design, for example, an incomplete block design, or missing completely at random. The Skillings-Mack test is equivalent to the Friedman test when there are no missing data in a balanced complete block design, and the Skillings-Mack test is equivalent to the test suggested in Durbin (1951, British Journal of Psychology, Statistical Section 4: 85-90) for a balanced incomplete block design. The Friedman test was implemented in Stata by Goldstein (1991, Stata Technical Bulletin 3: 26-27) and further developed in Goldstein (2005, Stata Journal 5: 285). This article introduces the skilmack command, which performs the Skillings-Mack test.The skilmack command is also useful when there are many ties or equal ranks (N.B. the Friedman statistic compared with the chi(2) distribution will give a conservative result), as well as for small samples; appropriate results can be obtained by simulating the distribution of the test statistic under the null hypothesis.

Feasibility of collecting 24-h urine to monitor sodium intake in the National Health and Nutrition Examination Survey123

PubMed Central

Terry, Ana L; Cogswell, Mary E; Wang, Chia-Yih; Chen, Te-Ching; Loria, Catherine M; Wright, Jacqueline D; Zhang, Xinli; Lacher, David A; Merritt, Robert K; Bowman, Barbara A

2016-01-01

Background: Twenty-four–hour urine sodium excretion is recommended for monitoring population sodium intake. Because of concerns about participation and completion, sodium excretion has not been collected previously in US nationally representative surveys. Objective: We assessed the feasibility of implementing 24-h urine collections as part of a nationally representative survey. Design: We selected a random half sample of nonpregnant US adults aged 20–69 y in 3 geographic locations of the 2013 NHANES. Participants received explicit instructions, started and ended the urine collection in a urine study mobile examination center, and answered questions about their collection. Among those with a complete 24-h urine collection, a random one-half were asked to collect a second 24-h urine sample. Sodium, potassium, chloride, and creatinine excretion were analyzed. Results: The final NHANES examination response rate for adults aged 20–69 y in these 3 study locations was 71%. Of those examined (n = 476), 282 (59%) were randomly selected to participate in the 24-h urine collection. Of these, 212 persons [75% of those selected for 24-h urine collection; 53% (equal to 71% × 75% of those selected for the NHANES)] collected a complete initial 24-h specimen and 92 persons (85% of 108 selected) collected a second complete 24-h urine sample. More men than women completed an initial collection (P = 0.04); otherwise, completion did not vary by sociodemographic characteristics, body mass index, education, or employment status for either collection. Mean 24-h urine volume and sodium excretion were 1964 ± 1228 mL and 3657 ± 2003 mg, respectively, for the first 24-h urine sample, and 2048 ± 1288 mL and 3773 ± 1891 mg, respectively, for the second collection. Conclusion: Given the 53% final component response rate and 75% completion rate, 24-h urine collections were deemed feasible and implemented in the NHANES 2014 on a subsample of adults aged 20–69 y to assess population sodium intake. This study was registered at clinicaltrials.gov as NCT02723682. PMID:27413136

An efficient dynamic load balancing algorithm

NASA Astrophysics Data System (ADS)

Lagaros, Nikos D.

2014-01-01

In engineering problems, randomness and uncertainties are inherent. Robust design procedures, formulated in the framework of multi-objective optimization, have been proposed in order to take into account sources of randomness and uncertainty. These design procedures require orders of magnitude more computational effort than conventional analysis or optimum design processes since a very large number of finite element analyses is required to be dealt. It is therefore an imperative need to exploit the capabilities of computing resources in order to deal with this kind of problems. In particular, parallel computing can be implemented at the level of metaheuristic optimization, by exploiting the physical parallelization feature of the nondominated sorting evolution strategies method, as well as at the level of repeated structural analyses required for assessing the behavioural constraints and for calculating the objective functions. In this study an efficient dynamic load balancing algorithm for optimum exploitation of available computing resources is proposed and, without loss of generality, is applied for computing the desired Pareto front. In such problems the computation of the complete Pareto front with feasible designs only, constitutes a very challenging task. The proposed algorithm achieves linear speedup factors and almost 100% speedup factor values with reference to the sequential procedure.

Utility-based designs for randomized comparative trials with categorical outcomes

PubMed Central

Murray, Thomas A.; Thall, Peter F.; Yuan, Ying

2016-01-01

A general utility-based testing methodology for design and conduct of randomized comparative clinical trials with categorical outcomes is presented. Numerical utilities of all elementary events are elicited to quantify their desirabilities. These numerical values are used to map the categorical outcome probability vector of each treatment to a mean utility, which is used as a one-dimensional criterion for constructing comparative tests. Bayesian tests are presented, including fixed sample and group sequential procedures, assuming Dirichlet-multinomial models for the priors and likelihoods. Guidelines are provided for establishing priors, eliciting utilities, and specifying hypotheses. Efficient posterior computation is discussed, and algorithms are provided for jointly calibrating test cutoffs and sample size to control overall type I error and achieve specified power. Asymptotic approximations for the power curve are used to initialize the algorithms. The methodology is applied to re-design a completed trial that compared two chemotherapy regimens for chronic lymphocytic leukemia, in which an ordinal efficacy outcome was dichotomized and toxicity was ignored to construct the trial’s design. The Bayesian tests also are illustrated by several types of categorical outcomes arising in common clinical settings. Freely available computer software for implementation is provided. PMID:27189672

The persuasiveness of synthetic speech versus human speech.

PubMed

Stern, S E; Mullennix, J W; Dyson, C; Wilson, S J

1999-12-01

Is computer-synthesized speech as persuasive as the human voice when presenting an argument? After completing an attitude pretest, 193 participants were randomly assigned to listen to a persuasive appeal under three conditions: a high-quality synthesized speech system (DECtalk Express), a low-quality synthesized speech system (Monologue), and a tape recording of a human voice. Following the appeal, participants completed a posttest attitude survey and a series of questionnaires designed to assess perceptions of speech qualities, perceptions of the speaker, and perceptions of the message. The human voice was generally perceived more favorably than the computer-synthesized voice, and the speaker was perceived more favorably when the voice was a human voice than when it was computer synthesized. There was, however, no evidence that computerized speech, as compared with the human voice, affected persuasion or perceptions of the message. Actual or potential applications of this research include issues that should be considered when designing synthetic speech systems.

Acceleration of block-matching algorithms using a custom instruction-based paradigm on a Nios II microprocessor

NASA Astrophysics Data System (ADS)

González, Diego; Botella, Guillermo; García, Carlos; Prieto, Manuel; Tirado, Francisco

2013-12-01

This contribution focuses on the optimization of matching-based motion estimation algorithms widely used for video coding standards using an Altera custom instruction-based paradigm and a combination of synchronous dynamic random access memory (SDRAM) with on-chip memory in Nios II processors. A complete profile of the algorithms is achieved before the optimization, which locates code leaks, and afterward, creates a custom instruction set, which is then added to the specific design, enhancing the original system. As well, every possible memory combination between on-chip memory and SDRAM has been tested to achieve the best performance. The final throughput of the complete designs are shown. This manuscript outlines a low-cost system, mapped using very large scale integration technology, which accelerates software algorithms by converting them into custom hardware logic blocks and showing the best combination between on-chip memory and SDRAM for the Nios II processor.

Low-Cost Behavioral Nudges Increase Medicaid Take-Up Among Eligible Residents Of Oregon.

PubMed

Wright, Bill J; Garcia-Alexander, Ginny; Weller, Margarette A; Baicker, Katherine

2017-05-01

Efforts to reduce the ranks of the uninsured hinge on take-up of available programs and subsidies, but take-up of even free insurance is often less than complete. The evidence of the effectiveness of policies aiming to increase take-up is limited. We used a randomized controlled design to evaluate the impact of improved communication and behaviorally informed "nudges" designed to increase Medicaid take-up among eligible populations. Fielding randomized interventions in two different study populations in Oregon, we found that even very low-cost interventions substantially increased enrollment. Effects were larger in a population whose members had already expressed interest in obtaining coverage, but the effects were more persistent in low-income populations whose members were already enrolled in other state assistance programs but had not expressed interest in health insurance. The effects were similar across different demographic groups. Our results suggest that improving the design of enrollment processes and using low-cost mass-outreach efforts have the potential to substantially increase insurance coverage of vulnerable populations. Project HOPE—The People-to-People Health Foundation, Inc.

Perception of young adults with sickle cell disease or sickle cell trait about participation in the CHOICES randomized controlled trial.

PubMed

Hershberger, Patricia E; Gallo, Agatha M; Molokie, Robert; Thompson, Alexis A; Suarez, Marie L; Yao, Yingwei; Wilkie, Diana J

2016-06-01

To gain an in-depth understanding of the perceptions of young adults with sickle cell disease and sickle cell trait about parenthood and participating in the CHOICES randomized controlled trial that used computer-based, educational programmes. In the USA, there is insufficient education to assure that all young adults with sickle cell disease or sickle cell trait understand genetic inheritance risks and reproductive options to make informed reproductive decisions. To address this educational need, we developed a computer-based, multimedia program (CHOICES) and reformatted usual care into a computer-based (e-Book) program. We then conducted a two-year randomized controlled trial that included a qualitative component that would deepen understanding of young adults' perceptions of parenthood and use of computer-based, educational programmes. A qualitative descriptive approach completed after a randomized controlled trial. Sixty-eight men and women of childbearing age participated in semi-structured interviews at the completion of the randomized controlled trial from 2012-2013. Thematic content analysis guided the qualitative description. Three main themes were identified: (1) increasing knowledge and new ways of thinking and behaving; (2) rethinking parenting plans; and (3) appraising the program design and delivery. Most participants reported increased knowledge and rethinking of their parenting plans and were supportive of computer-based learning. Some participants expressed difficulty in determining individual transmission risks. Participants perceived the computer programs as beneficial to their learning. Future development of an Internet-based educational programme is warranted, with emphasis on providing tailored education or memory boosters about individual transmission risks. © 2015 John Wiley & Sons Ltd.

An entertainment-education colorectal cancer screening decision aid for African American patients: A randomized controlled trial.

PubMed

Hoffman, Aubri S; Lowenstein, Lisa M; Kamath, Geetanjali R; Housten, Ashley J; Leal, Viola B; Linder, Suzanne K; Jibaja-Weiss, Maria L; Raju, Gottumukkala S; Volk, Robert J

2017-04-15

Colorectal cancer screening rates for African American patients remain suboptimal. Patient decision aids designed with an entertainment-education approach have been shown to improve saliency and foster informed decision making. The purpose of this study was to assess whether an entertainment-education decision aid tailored for African American patients improved patients' decision making, attitudes, intentions, or colorectal cancer screening behavior. Eighty-nine participants were randomized to view 1) a patient decision aid video containing culturally tailored information about colorectal cancer screening options and theory-based support in decision making presented in an entertainment-education format or 2) an attention control video about hypertension that contained similarly detailed information. Participants met with their clinician and then completed follow-up questionnaires assessing their knowledge, decisional conflict, self-advocacy, attitudes, perceived social norms, and intentions. At 3 months, completion of screening was assessed by chart review. Viewing the culturally tailored decision aid significantly increased African American patients' knowledge of colorectal cancer screening recommendations and options. It also significantly reduced their decisional conflict and improved their self-advocacy. No significant differences were observed in participants' attitudes, norms, or intentions. At three months, 23% of all patients had completed a colonoscopy. Designing targeted, engaging patient decision aids for groups that receive suboptimal screening holds promise for improving patient decision making and self-advocacy. Additional research is warranted to investigate the effectiveness of such aids in clinical practices with suboptimal screening rates and on downstream behaviors (such as repeat testing). Cancer 2017;123:1401-1408. © 2016 American Cancer Society. © 2016 American Cancer Society.

Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness.

PubMed

Zhao, Wenle; Weng, Yanqiu; Wu, Qi; Palesch, Yuko

2012-01-01

To evaluate the performance of randomization designs under various parameter settings and trial sample sizes, and identify optimal designs with respect to both treatment imbalance and allocation randomness, we evaluate 260 design scenarios from 14 randomization designs under 15 sample sizes range from 10 to 300, using three measures for imbalance and three measures for randomness. The maximum absolute imbalance and the correct guess (CG) probability are selected to assess the trade-off performance of each randomization design. As measured by the maximum absolute imbalance and the CG probability, we found that performances of the 14 randomization designs are located in a closed region with the upper boundary (worst case) given by Efron's biased coin design (BCD) and the lower boundary (best case) from the Soares and Wu's big stick design (BSD). Designs close to the lower boundary provide a smaller imbalance and a higher randomness than designs close to the upper boundary. Our research suggested that optimization of randomization design is possible based on quantified evaluation of imbalance and randomness. Based on the maximum imbalance and CG probability, the BSD, Chen's biased coin design with imbalance tolerance method, and Chen's Ehrenfest urn design perform better than popularly used permuted block design, EBCD, and Wei's urn design. Copyright © 2011 John Wiley & Sons, Ltd.

Complementary and Alternative Medicine Use Among US Navy and Marine Corps Personnel

DTIC Science & Technology

2007-05-16

protection of human subjects in research (Protocol NHRC.2001.0001). Postal survey The choice of questions and question layouts for the sur- vey instrument were...specific health problems within the past 12 months. The optically scanned 10-page survey instrument was designed to take approximately 30 minutes to...suggestions, the survey instrument was refined before the initial mailing. Additionally, a random sample of 33% of individuals who completed the

Complementary and Alternative Medicine Use Among US Navy and Marine Corps Personnel

DTIC Science & Technology

2007-05-16

subjects in research (Protocol NHRC.2001.0001). Postal survey The choice of questions and question layouts for the sur- vey instrument were modeled...health problems within the past 12 months. The optically scanned 10-page survey instrument was designed to take approximately 30 minutes to com- plete...the survey instrument was refined before the initial mailing. Additionally, a random sample of 33% of individuals who completed the initial

Effect of Fertilization on Growth and Wood Properties of Thinned and Un-thinned Mid-rotation Loblolly Pine (Pinus taeda L.) Stands

Treesearch

Finto Antony; Laurence R. Schimleck; Richard F. Daniels; Alexander Clark

2011-01-01

Growth and wood properties were measured on breast height cores collected from two stands, New Bern and Bertie, located in the lower Coastal Plain of North Carolina. The New Bern site was thinned before fertilizer application, and the Bertie site was not. The study was laid out in a randomized complete block design with each treatment replicated in four blocks at New...

Development of Understory Vegetation in Pine and Pine-Hardwood Shelterwood Stands in the Ouachita Mountains-the First 3 Years

Treesearch

Michael G. Shelton

1997-01-01

The shelterwood reproduction cutting method using two overstory compositions (a pine basal area of 30 ft* per acre with and without 15 ft’ per acre of hardwoods) and two methods of submerchantable hardwood control (chain-saw felling with and without stump-applied herbicide) was tested in a 2x2 factorial, split-plot design with four randomized complete blocks....

The influence from combinations of prescribed fire, herbicide injection, and partial overstory removal on restoration of natural oak stands in the Arkansas Ozarks

Treesearch

K. Kyle Cunningham; Michael S. McGowan; H. Christoph Stuhlinger

2016-01-01

Two studies were conducted in the Springfield Plateau province of the Arkansas Ozarks from 2009 to 2014 incorporating the applied silvicultural methods proven beneficial to promote oak natural reproduction. The first study, River Hills, was a completely randomized design with treatments including: partial overstory removal to basal area 50 (BA50), partial overstory...

Imposed Power of Breathing Associated With Use of an Impedance Threshold Device

DTIC Science & Technology

2007-02-01

threshold device and a sham impedance threshold device. DESIGN: Prospective randomized blinded protocol. SETTING: University medical center. PATIENTS...for males). METHODS: The volunteers completed 2 trials of breathing through a face mask fitted with an active impedance threshold device set to open...at -7cmH 2 O pressure, or with a sham impedance threshold device, which was identical to the active device except that it did not contain an

Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods

PubMed Central

2010-01-01

Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. Trial registration ClinicalTrials.gov NCT00052078. PMID:20051130

Recruiting participants with peripheral arterial disease for clinical trials: experience from the Study to Improve Leg Circulation (SILC).

PubMed

McDermott, Mary M; Domanchuk, Kathryn; Dyer, Alan; Ades, Philip; Kibbe, Melina; Criqui, Michael H

2009-03-01

To describe the success of diverse recruitment methods in a randomized controlled clinical trial of exercise in persons with peripheral arterial disease (PAD). An analysis of recruitment sources conducted for the 746 men and women completing a baseline visit for the study to improve leg circulation (SILC), a randomized controlled trial of exercise for patients with PAD. For each recruitment source, we determined the number of randomized participants, the rate of randomization among those completing a baseline visit, and cost per randomized participant. Of the 746 individuals who completed a baseline visit, 156 were eligible and randomized. The most frequent sources of randomized participants were newspaper advertising (n = 67), mailed recruitment letters to patients with PAD identified at the study medical center (n = 25), and radio advertising (n = 18). Costs per randomized participant were $2750 for television advertising, $2167 for Life Line Screening, $2369 for newspaper advertising, $3931 for mailed postcards to older community dwelling men and women, and $5691 for radio advertising. Among those completing a baseline visit, randomization rates ranged from 10% for those identified from radio advertising to 32% for those identified from the Chicago Veterans Administration and 33% for those identified from posted flyers. Most participants in a randomized controlled trial of exercise were recruited from newspaper advertising and mailed recruitment letters to patients with known PAD. The highest randomization rates after a baseline visit occurred among participants identified from posted flyers and mailed recruitment letters to PAD patients.

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project.

PubMed

Merle, Corinne S C; Sismanidis, Charalambos; Sow, Oumou Bah; Gninafon, Martin; Horton, John; Lapujade, Olivier; Lo, Mame Bocar; Mitchinson, Denis A; Perronne, Christian; Portaels, Francoise; Odhiambo, Joseph; Olliaro, Piero; Rustomjee, Roxana; Lienhardt, Christian; Fielding, Katherine

2012-05-18

There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish between relapse and re-infection.

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

PubMed Central

2012-01-01

Background There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Methods Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). Results In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. Conclusion When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish between relapse and re-infection. PMID:22607233

Effects of form-focused training on running biomechanics: A pilot randomized trial in untrained individuals

PubMed Central

Kumar, Deepak; McDermott, Kelly; Feng, Haojun; Goldman, Veronica; Luke, Anthony; Souza, Richard B; Hecht, Frederick M

2015-01-01

Objective To investigate the changes in running biomechanics after training in Form-Focused running using ChiRunning vs. Not-Form focused training and Self-Directed training in untrained individuals. Design Pilot study - Randomized controlled trial. Setting Research Institution with Tertiary Care Medical Center. Participants Seventeen subjects (9 males, 8 females) with pre-hypertension. Methods Twenty-two participants were randomized to three study arms but 17 completed the study. The study arms were: 1) group-based Form-Focused running using ChiRunning (enrolled, n =10; completed, n=7); 2) group-based conventional running (enrolled, n=6; completed, n=4); 3) self-directed training with educational materials (enrolled, n =6; completed, n=6). The training schedule was prescribed for 8 weeks with 4 weeks of follow-up. All subjects completed overground running motion analyses before and after training. Outcomes Ankle, knee, hip joint peak moments and powers; Average vertical loading rate (AVLR), impact peak, cadence, stride length, strike index, and stride reach. Paired T-tests were used to compare differences with-in groups over-time. Results Form-Focused group reduced their Stride Reach (P = .047) after the training but not the other groups. Form-Focused group showed a close to significant reduction in knee adduction moment (P = .051) and a reduction in the peak ankle eversion moment (P = .027). Self-Directed group showed an increase in the running speed, (P =.056) and increases in ankle and knee joint powers and moments. Conclusions There are differences in the changes in running biomechanics between individuals trained in running form that emphazies mid-foot strike, higher cadence, and shorter stride compared to those not trained in the thise technique. These differences may be associated with reduced lower extremity stress in individuals trained in this running form but future studies are needed to confirm these findings in larger samples. PMID:25633634

Clinical and Morphological Changes Following 2 Rehabilitation Programs for Acute Hamstring Strain Injuries: A Randomized Clinical Trial

PubMed Central

SILDER, AMY; SHERRY, MARC A.; SANFILIPPO, JENNIFER; TUITE, MICHAEL J.; HETZEL, SCOTT J.; HEIDERSCHEIT, BRYAN C.

2013-01-01

STUDY DESIGN Randomized, double-blind, parallel-group clinical trial. OBJECTIVES To assess differences between a progressive agility and trunk stabilization rehabilitation program and a progressive running and eccentric strengthening rehabilitation program in recovery characteristics following an acute hamstring injury, as measured via physical examination and magnetic resonance imaging (MRI). BACKGROUND Determining the type of rehabilitation program that most effectively promotes muscle and functional recovery is essential to minimize reinjury risk and to optimize athlete performance. METHODS Individuals who sustained a recent hamstring strain injury were randomly assigned to 1 of 2 rehabilitation programs: (1) progressive agility and trunk stabilization or (2) progressive running and eccentric strengthening. MRI and physical examinations were conducted before and after completion of rehabilitation. RESULTS Thirty-one subjects were enrolled, 29 began rehabilitation, and 25 completed rehabilitation. There were few differences in clinical or morphological outcome measures between rehabilitation groups across time, and reinjury rates were low for both rehabilitation groups after return to sport (4 of 29 subjects had reinjuries). Greater craniocaudal length of injury, as measured on MRI before the start of rehabilitation, was positively correlated with longer return-to-sport time. At the time of return to sport, although all subjects showed a near-complete resolution of pain and return of muscle strength, no subject showed complete resolution of injury as assessed on MRI. CONCLUSION The 2 rehabilitation programs employed in this study yielded similar results with respect to hamstring muscle recovery and function at the time of return to sport. Evidence of continuing muscular healing is present after completion of rehabilitation, despite the appearance of normal physical strength and function on clinical examination. LEVEL OF EVIDENCE Therapy, level 1b–. J Orthop Sports Phys Ther 2013;43(5):284-299. Epub 13 March 2013. doi:10.2519/jospt.2013.4452 PMID:23485730

Sequential multiple-assignment randomized trial design of neurobehavioral treatment for patients with metastatic malignant melanoma undergoing high-dose interferon-alpha therapy.

PubMed

Auyeung, S Freda; Long, Qi; Royster, Erica Bruce; Murthy, Smitha; McNutt, Marcia D; Lawson, David; Miller, Andrew; Manatunga, Amita; Musselman, Dominique L

2009-10-01

Interferon-alpha therapy, which is used to treat metastatic malignant melanoma, can cause patients to develop two distinct neurobehavioral symptom complexes: a mood syndrome and a neurovegetative syndrome. Interferon-alpha effects on serotonin metabolism appear to contribute to the mood and anxiety syndrome, while the neurovegetative syndrome appears to be related to interferon-alpha effects on dopamine. Our goal is to propose a design for utilizing a sequential, multiple assignment, randomized trial design for patients with malignant melanoma to test the relative efficacy of drugs that target serotonin versus dopamine metabolism during 4 weeks of intravenous, then 8 weeks of subcutaneous, interferon-alpha therapy. Patients will be offered participation in a double-blinded, randomized, controlled, 14-week trial involving two treatment phases. During the first month of intravenous interferon-alpha therapy, we will test the hypotheses that escitalopram will be more effective in reducing depressed mood, anxiety, and irritability, whereas methylphenidate will be more effective in diminishing interferon-alpha-induced neurovegetative symptoms, such as fatigue and psychomotor slowing. During the next 8 weeks of subcutaneous interferon therapy, participants whose symptoms do not improve significantly will be randomized to the alternate agent alone versus escitalopram and methylphenidate together. We present a prototype for a single-center, sequential, multiple assignment, randomized trial, which seeks to determine the efficacy of sequenced and targeted treatment for the two distinct symptom complexes suffered by patients treated with interferon-alpha. Because we cannot completely control for external factors, a relevant question is whether or not 'short-term' neuropsychiatric interventions can increase the number of interferon-alpha doses tolerated and improve long-term survival. This sequential, multiple assignment, randomized trial proposes a framework for developing optimal treatment strategies; however, additional studies are needed to determine the best strategy for treating or preventing neurobehavioral symptoms induced by the immunotherapy interferon-alpha.

Random spectrum loading of dental implants: An alternative approach to functional performance assessment.

PubMed

Shemtov-Yona, K; Rittel, D

2016-09-01

The fatigue performance of dental implants is usually assessed on the basis of cyclic S/N curves. This neither provides information on the anticipated service performance of the implant, nor does it allow for detailed comparisons between implants unless a thorough statistical analysis is performed, of the kind not currently required by certification standards. The notion of endurance limit is deemed to be of limited applicability, given unavoidable stress concentrations and random load excursions, that all characterize dental implants and their service conditions. We propose a completely different approach, based on random spectrum loading, as long used in aeronautical design. The implant is randomly loaded by a sequence of loads encompassing all load levels it would endure during its service life. This approach provides a quantitative and comparable estimate of its performance in terms of lifetime, based on the very fact that the implant will fracture sooner or later, instead of defining a fatigue endurance limit of limited practical application. Five commercial monolithic Ti-6Al-4V implants were tested under cyclic, and another 5 under spectrum loading conditions, at room temperature and dry air. The failure modes and fracture planes were identical for all implants. The approach is discussed, including its potential applications, for systematic, straightforward and reliable comparisons of various implant designs and environments, without the need for cumbersome statistical analyses. It is believed that spectrum loading can be considered for the generation of new standardization procedures and design applications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Randomized Controlled Trial of Expressive Writing and Quality of Life in Men and Women Treated for Colorectal Cancer

PubMed Central

Lepore, Stephen J.; Revenson, Tracey A.; Roberts, Katherine J.; Pranikoff, Julie R.; Davey, Adam

2014-01-01

Objective This randomized trial tested (1) whether a home-based expressive writing (EW) intervention improves quality of life in patients with colorectal cancer and (2) whether the intervention is more beneficial for men or for people who feel constrained in disclosing cancer-related concerns and feelings. Design Patients treated for colorectal cancer were randomized to an EW (n = 101) or control writing (CW; n = 92) group. Assessments were completed at 1 month pre- and post-intervention. Sex and perceived social constraints on disclosure were evaluated as moderators. Main Outcome Measures Primary outcomes were depressive symptoms, sleep problems and quality of life indicators. Results 81% of participants completed all writing assignments. Consistent with hypotheses, relative to the CW group, participants in the EW group expressed more emotion in writing and rated their writings as more meaningful, personal, and emotionally revealing. There were no significant main effects of EW or moderating effects of sex or social constraints on outcomes. Conclusions Although EW is feasible to use with persons who have colorectal cancer, it was not effective as a stand-alone psychotherapeutic intervention. Nor was it more effective for men or for people who felt they could not freely disclose cancer-related concerns and feelings. PMID:25271396

The effect of sexual health education program on women sexual function in Iran.

PubMed

Behboodi Moghadam, Zahra; Rezaei, Elham; Khaleghi Yalegonbadi, Fariba; Montazeri, Ali; Arzaqi, Syed Masood; Tavakol, Zeinab; Yari, Fatemeh

2015-01-01

Sexual dysfunction is the most common disorder in women. According to the WHO, sexual education programs are considered as a need. Therefore, this study was designed to investigate the effect of educational program on sexual function in women with sexual dysfunction. This randomized trial, was conducted in 2013 on 90 married women by convenient sampling in Qazvin, central Iran. The demographic, Female Sexual Function Index (FSFI), and Beck's Depression Inventory (BDI) questionnaires were completed during structured interviews. After completing the sample size, subjects were divided randomly into two groups by using the table of random numbers (educational and control groups), then respectively received an educational intervention in the four sessions with one week interval and routine program offered by the center and following-up was done with refilling questionnaires 8 weeks after intervention. Sexual function improved after sex educational programs in all dimensions (sexual desire (P=0.006), sexual exciting (P=0.006), vaginal moisture (P=0.002), sexual satisfaction (P=0.011), and total score of sexual function (P=0.001). Considering the importance role of sexual function in family strength, health, and development, it can be claimed that educational sex programs can help practitioners to improve sexual function of married women with sexual dysfunction.

Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial.

PubMed

Marissen, Marlies A E; Franken, Ingmar H A; Blanken, Peter; van den Brink, Wim; Hendriks, Vincent M

2007-01-01

Persistent cue reactivity to drug-related stimuli is a well-known phenomenon among abstinent drug users and has been found to be a predictor of relapse. Cue exposure therapy (CET) aims to reduce this cue reactivity by exposing abstinent drug users to conditioned drug-related stimuli while preventing their habitual response, i.e. drug use. 127 abstinent heroin-dependent Dutch inpatients were randomized to CET (n = 65; 55 completers) and placebo psychotherapy treatment (PPT) (n = 62; 59 completers). It was examined whether CET would lead to a decrease in drug-related cue reactivity (using mixed-design ANOVA) and subsequently to lower dropout and relapse rates (using logistic regression) compared to PPT. Both groups responded with a similar decrease in self-reported cue reactivity (craving, mood). The CET group did show a significant decrease in physiological reactivity (skin conductance) compared to PPT. However, dropout and relapse rates were, contrary to our expectations, significantly higher in the CET group. This is the first randomized controlled trial showing that CET, compared to a non-specific psychotherapy, might increase dropout and relapse rates among abstinent heroin-dependent clients in a drug-free setting. Caution is warranted when applying CET in this specific context. Copyright 2007 S. Karger AG, Basel.

Does user-centred design affect the efficiency, usability and safety of CPOE order sets?

PubMed

Chan, Julie; Shojania, Kaveh G; Easty, Anthony C; Etchells, Edward E

2011-05-01

Application of user-centred design principles to Computerized provider order entry (CPOE) systems may improve task efficiency, usability or safety, but there is limited evaluative research of its impact on CPOE systems. We evaluated the task efficiency, usability, and safety of three order set formats: our hospital's planned CPOE order sets (CPOE Test), computer order sets based on user-centred design principles (User Centred Design), and existing pre-printed paper order sets (Paper). 27 staff physicians, residents and medical students. Sunnybrook Health Sciences Centre, an academic hospital in Toronto, Canada. Methods Participants completed four simulated order set tasks with three order set formats (two CPOE Test tasks, one User Centred Design, and one Paper). Order of presentation of order set formats and tasks was randomized. Users received individual training for the CPOE Test format only. Completion time (efficiency), requests for assistance (usability), and errors in the submitted orders (safety). 27 study participants completed 108 order sets. Mean task times were: User Centred Design format 273 s, Paper format 293 s (p=0.73 compared to UCD format), and CPOE Test format 637 s (p<0.0001 compared to UCD format). Users requested assistance in 31% of the CPOE Test format tasks, whereas no assistance was needed for the other formats (p<0.01). There were no significant differences in number of errors between formats. The User Centred Design format was more efficient and usable than the CPOE Test format even though training was provided for the latter. We conclude that application of user-centred design principles can enhance task efficiency and usability, increasing the likelihood of successful implementation.

Does user-centred design affect the efficiency, usability and safety of CPOE order sets?

PubMed Central

Chan, Julie; Shojania, Kaveh G; Easty, Anthony C

2011-01-01

Background Application of user-centred design principles to Computerized provider order entry (CPOE) systems may improve task efficiency, usability or safety, but there is limited evaluative research of its impact on CPOE systems. Objective We evaluated the task efficiency, usability, and safety of three order set formats: our hospital's planned CPOE order sets (CPOE Test), computer order sets based on user-centred design principles (User Centred Design), and existing pre-printed paper order sets (Paper). Participants 27staff physicians, residents and medical students. Setting Sunnybrook Health Sciences Centre, an academic hospital in Toronto, Canada. Methods Participants completed four simulated order set tasks with three order set formats (two CPOE Test tasks, one User Centred Design, and one Paper). Order of presentation of order set formats and tasks was randomized. Users received individual training for the CPOE Test format only. Main Measures Completion time (efficiency), requests for assistance (usability), and errors in the submitted orders (safety). Results 27 study participants completed 108 order sets. Mean task times were: User Centred Design format 273 s, Paper format 293 s (p=0.73 compared to UCD format), and CPOE Test format 637 s (p<0.0001 compared to UCD format). Users requested assistance in 31% of the CPOE Test format tasks, whereas no assistance was needed for the other formats (p<0.01). There were no significant differences in number of errors between formats. Conclusions The User Centred Design format was more efficient and usable than the CPOE Test format even though training was provided for the latter. We conclude that application of user-centred design principles can enhance task efficiency and usability, increasing the likelihood of successful implementation. PMID:21486886

The effect of four user interface concepts on visual scan pattern similarity and information foraging in a complex decision making task.

PubMed

Starke, Sandra D; Baber, Chris

2018-07-01

User interface (UI) design can affect the quality of decision making, where decisions based on digitally presented content are commonly informed by visually sampling information through eye movements. Analysis of the resulting scan patterns - the order in which people visually attend to different regions of interest (ROIs) - gives an insight into information foraging strategies. In this study, we quantified scan pattern characteristics for participants engaging with conceptually different user interface designs. Four interfaces were modified along two dimensions relating to effort in accessing information: data presentation (either alpha-numerical data or colour blocks), and information access time (all information sources readily available or sequential revealing of information required). The aim of the study was to investigate whether a) people develop repeatable scan patterns and b) different UI concepts affect information foraging and task performance. Thirty-two participants (eight for each UI concept) were given the task to correctly classify 100 credit card transactions as normal or fraudulent based on nine transaction attributes. Attributes varied in their usefulness of predicting the correct outcome. Conventional and more recent (network analysis- and bioinformatics-based) eye tracking metrics were used to quantify visual search. Empirical findings were evaluated in context of random data and possible accuracy for theoretical decision making strategies. Results showed short repeating sequence fragments within longer scan patterns across participants and conditions, comprising a systematic and a random search component. The UI design concept showing alpha-numerical data in full view resulted in most complete data foraging, while the design concept showing colour blocks in full view resulted in the fastest task completion time. Decision accuracy was not significantly affected by UI design. Theoretical calculations showed that the difference in achievable accuracy between very complex and simple decision making strategies was small. We conclude that goal-directed search of familiar information results in repeatable scan pattern fragments (often corresponding to information sources considered particularly important), but no repeatable complete scan pattern. The underlying concept of the UI affects how visual search is performed, and a decision making strategy develops. This should be taken in consideration when designing for applied domains. Copyright © 2018 Elsevier Ltd. All rights reserved.

Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial.

PubMed

Carey, Michael P; Senn, Theresa E; Coury-Doniger, Patricia; Urban, Marguerite A; Vanable, Peter A; Carey, Kate B

2013-09-01

Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. © 2013 Elsevier Inc. All rights reserved.

Methodological Overview of an African American Couple-Based HIV/STD Prevention Trial

PubMed Central

2010-01-01

Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history). Conclusions The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples based clinical trials in HIV/STD risk reduction and can be generalized to other couples based behavioral interventions. PMID:18724188

A Pilot Study of Women’s Affective Responses to Common and Uncommon Forms of Aerobic Exercise

PubMed Central

Stevens, Courtney J.; Smith, Jane Ellen; Bryan, Angela D.

2015-01-01

Objective To test the extent to which participants exposed to an uncommon versus common exercise stimulus would result in more favourable affect at post task. Design Experimental design. Participants, (N = 120) American women aged 18–45 years, were randomly assigned to complete 30-minutes of either the uncommon (HOOP; n = 58) or common (WALK; n = 62) exercise stimulus. Main Outcome Measures Self-reported affect and intentions for future exercise were measured before and after the 30-minute exercise bout. Results Analyses of covariance (ANCOVA) were run to compare post-task affect across the HOOP and WALK conditions. At post-task, participants assigned to HOOP reported more positively valenced affect, higher ratings of positive activated affect, lower ratings of negative deactivated affect, and stronger intentions for future aerobic exercise compared to participants assigned to WALK. Conclusions Participants who completed an uncommon bout of aerobic exercise (HOOP) reported more favourable affect post-exercise, as well as stronger intentions for future exercise, compared to participants who completed a common bout of aerobic exercise (WALK). Future work using a longitudinal design is needed to understand the relationships between familiarity with an exercise stimulus, affective responses to exercise, motivation for future exercise behaviour, and exercise maintenance over time. PMID:26394246

The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.

PubMed

Rash, Joshua A; Lavoie, Kim L; Sigal, Ronald J; Campbell, David J T; Manns, Braden J; Tonelli, Marcello; Campbell, Tavis S

2016-07-01

Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication. Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile. Copyright © 2016 Elsevier Inc. All rights reserved.

Next-generation avionics packaging and cooling 'test results from a prototype system'

NASA Astrophysics Data System (ADS)

Seals, J. D.

The author reports on the design, material characteristics, and test results obtained under the US Air Force's advanced aircraft avionics packaging technologies (AAAPT) program, whose charter is to investigate new designs and technologies for reliable packaging, interconnection, and thermal management. Under this program, AT&T Bell Laboratories has completed the preliminary testing of and is evaluating a number of promising materials and technologies, including conformal encapsulation, liquid flow-through cooling, and a cyanate ester backplane. A fifty-two module system incorporating these and and other technologies has undergone preliminary cooling efficiency, shock, sine and random vibration, and maintenance testing. One of the primary objectives was to evaluate the interaction compatibility of new materials and designs with other components in the system.

Current Status of Renal Denervation in Hypertension.

PubMed

Briasoulis, Alexander; Bakris, George L

2016-11-01

Over the past 7 years, prospective cohorts and small randomized controlled studies showed that renal denervation therapy (RDN) in patients with resistant hypertension is safe but associated with variable effects on BP which are not substantially better than medical therapy alone. The failure of the most rigorously designed randomized sham-control study, SYMPLICITY HTN-3, to meet the efficacy endpoints has raised several methodological concerns. However, recently reported studies and ongoing trials with improved procedural characteristics, identification of patients with true treatment-resistant hypertension on appropriate antihypertensive regimens further explore potential benefits of RDN. The scope of this review is to summarize evidence from currently completed studies on RDN and discuss future perspectives of RDN therapy in patients with resistant hypertension.

Formulation, Rate and Season and Application Effects of Hexazinone (Velpar) Gridball on Oak Topkill

Treesearch

J.L. Michael

1980-01-01

Hexazinone [3-cyclohexyl-6-(dimethylamino)-1-methyl-l,3,5-triazine-2,4(1H,2H)-dione] gridball was tested for site preparation on a loamy sand soil. The gridball was applied in the 1 and 2 cc formulations at 0.56, 0.84 and 1.12 kg ai/ha in a completel~y randomized design with three replications in April, June, and August 1978. After two growing seasons the 1 cc...

Design and evaluation of an aerial spray trial with true replicates to test the efficacy of Bacillus thuringiensis insecticide in a boreal forest.

PubMed

Cadogan, Beresford L; Scharbach, Roger D

2003-04-01

A field trial using true replicates was conducted successfully in a boreal forest in 1996 to evaluate the efficacy of two aerially applied Bacillus thuringiensis formulations, ABG 6429 and ABG 6430. A complete randomized design with four replicates per treatment was chosen. Twelve to 15 balsam fir (Abies balsamea [L.] Mill.) per plot were randomly selected as sample trees. Interplot buffer zones, > or = 200 m wide, adequately prevented cross contamination from sprays that were atomized with four rotary atomizers (volume median diameters ranging from 64.6 to 139.4 microm) and released approximately 30 m above the ground. The B. thuringiensis formulations were not significantly different (P > 0.05) from each other in reducing spruce budworm (Choristoneura fumiferana [Clem.]) populations and protecting balsam trees from defoliation but both formulations were significantly more efficacious than the controls. The results suggest that true replicates are a feasible alternative to pseudoreplication in experimental forest aerial applications.

Nursing Case Management, Peer Coaching, and Hepatitis A and B Vaccine Completion Among Homeless Men Recently Released on Parole: Randomized Clinical Trial

PubMed Central

Nyamathi, Adeline; Salem, Benissa E.; Zhang, Sheldon; Farabee, David; Hall, Betsy; Khalilifard, Farinaz; Leake, Barbara

2015-01-01

Background Although hepatitis A virus (HAV) and hepatitis B virus (HBV) infections are vaccine-preventable diseases, few homeless parolees coming out of prisons and jails have received the hepatitis A and B vaccination series. Objectives The study focused on completion of the HAV and HBV vaccine series among homeless men on parole. The efficacy of three levels of peer coaching and nurse-delivered interventions was compared at 12-month follow up: (a) intensive peer coaching and nurse case management (PC-NCM); (b) intensive peer coaching (PC) intervention condition, with minimal nurse involvement; and a (c) usual care (UC) intervention condition, which included minimal PC and nurse involvement. Further, we assessed predictors of vaccine completion among this targeted sample. Methods A randomized control trial was conducted with 600 recently paroled men to assess the impact of the three intervention conditions (PC-NCM vs. PC vs. UC) on reducing drug use and recidivism; of these, 345 seronegative, vaccine-eligible subjects were included in this analysis of completion of the Twinrix HAV/HAB vaccine. Logistic regression was added to assess predictors of completion of the HAV/HBV vaccine series and chi-squared analysis to compare completion rates across the three levels of intervention. Results Vaccine completion rate for the intervention conditions were 75.4% (PC-NCM), 71.8% (PC), and 71.9% (UC) (p =. 78). Predictors of vaccine noncompletion included being Asian and Pacific Islander, experiencing high levels of hostility, positive social support, reporting a history of injection drug use, being released early from California prisons, and being admitted for psychiatric illness. Predictors of vaccine series completion included reporting six or more friends, recent cocaine use, and staying in drug treatment for at least 90 days. Discussion Findings allow greater understanding of factors affecting vaccination completion in order to design more effective programs among the high-risk population of men recently released from prison and on parole. PMID:25932697

Nursing case management, peer coaching, and hepatitis a and B vaccine completion among homeless men recently released on parole: randomized clinical trial.

PubMed

Nyamathi, Adeline; Salem, Benissa E; Zhang, Sheldon; Farabee, David; Hall, Betsy; Khalilifard, Farinaz; Leake, Barbara

2015-01-01

Although hepatitis A virus (HAV) and hepatitis B virus (HBV) infections are vaccine-preventable diseases, few homeless parolees coming out of prisons and jails have received the hepatitis A and B vaccination series. The study focused on completion of the HAV and HBV vaccine series among homeless men on parole. The efficacy of three levels of peer coaching (PC) and nurse-delivered interventions was compared at 12-month follow-up: (a) intensive peer coaching and nurse case management (PC-NCM); (b) intensive PC intervention condition, with minimal nurse involvement; and (c) usual care (UC) intervention condition, which included minimal PC and nurse involvement. Furthermore, we assessed predictors of vaccine completion among this targeted sample. A randomized control trial was conducted with 600 recently paroled men to assess the impact of the three intervention conditions (PC-NCM vs. PC vs. UC) on reducing drug use and recidivism; of these, 345 seronegative, vaccine-eligible subjects were included in this analysis of completion of the Twinrix HAV/HBV vaccine. Logistic regression was added to assess predictors of completion of the HAV/HBV vaccine series and chi-square analysis to compare completion rates across the three levels of intervention. Vaccine completion rate for the intervention conditions were 75.4% (PC-NCM), 71.8% (PC), and 71.9% (UC; p = .78). Predictors of vaccine noncompletion included being Asian and Pacific Islander, experiencing high levels of hostility, positive social support, reporting a history of injection drug use, being released early from California prisons, and being admitted for psychiatric illness. Predictors of vaccine series completion included reporting having six or more friends, recent cocaine use, and staying in drug treatment for at least 90 days. Findings allow greater understanding of factors affecting vaccination completion in order to design more effective programs among the high-risk population of men recently released from prison and on parole.

The effects of umbilical cord milking in extremely preterm infants: a randomized controlled trial

PubMed Central

March, MI; Hacker, MR; Parson, AW; Modest, AM; de Veciana, M

2014-01-01

OBJECTIVE Delayed cord clamping has been shown to decrease the need for transfusion in preterm neonates, but may delay resuscitation. The aim of this study was to determine whether umbilical cord milking compared with immediate cord clamping in extremely preterm deliveries reduces the need for neonatal red blood cell transfusion. STUDY DESIGN Women admitted to a tertiary care center and expected to deliver between 24 to 28 completed weeks of gestation were randomized to cord milking before clamping or immediate cord clamping. The primary outcome was the risk of neonatal transfusion, reported as risk ratio (RR) and 95% confidence interval (CI). RESULT Of 113 women who were enrolled and randomized, 56 were assigned to cord milking with 36 remaining eligible and completing the study and 57 were assigned to the control group with 39 remaining eligible and completing the study. Albeit not statistically significant, neonates in the cord milking group were less likely to require transfusion compared with those in the control group (RR: 0.86; 95% CI: 0.73 to 1.0). Neonates whose cords were milked had higher hematocrits at birth (P = 0.004) and were less likely to develop an intraventricular hemorrhage (P = 0.0195). CONCLUSION Milking the umbilical cord of a preterm neonate is an easy intervention with the potential to improve perinatal outcomes. Our results suggest that milking of the cord increases the neonate’s initial hematocrit and may lessen the need for transfusion in the neonatal period. The observed reduction in the incidence of intraventricular hemorrhage may have important long-term implications that warrant further study. PMID:23867960

A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

PubMed

Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

2018-05-01

To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Tobacco dependence counseling in a randomized multisite clinical trial

PubMed Central

Croghan, Ivana T.; Trautman, Judith A.; Winhusen, Theresa; Ebbert, Jon O.; Kropp, Frankie; Schroeder, Darrell R.; Hurt, Richard D.

2012-01-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a “train-the-trainer” model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3 ± 2.8 sessions (mean ± SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and “meeting expectations” on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. PMID:22406192

Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial).

PubMed

Ballard, Clive; Brown, Richard; Fossey, Jane; Douglas, Simon; Bradley, Paul; Hancock, Judith; James, Ian A; Juszczak, Edmund; Bentham, Peter; Burns, Alistair; Lindesay, James; Jacoby, Robin; O'Brien, John; Bullock, Roger; Johnson, Tony; Holmes, Clive; Howard, Robert

2009-09-01

Good practice guidelines state that a psychological intervention should usually precede pharmacotherapy, but there are no data evaluating the feasibility of psychological interventions used in this way. At the first stage of a randomized blinded placebo-controlled trial, 318 patients with Alzheimer disease (AD) with clinically significant agitated behavior were treated in an open design with a psychological intervention (brief psychosocial therapy [BPST]) for 4 weeks, preceding randomization to pharmacotherapy. The therapy involved social interaction, personalized music, or removal of environmental triggers. Overall, 318 patients with AD completed BPST with an improvement of 5.6 points on the total Cohen-Mansfield Agitation Inventory (CMAI; mean [SD], 63.3 [16.0] to 57.7 [18.4], t = 4.8, df = 317, p < 0.0001). Therapy worksheets were completed in six of the eight centers, with the key elements of the intervention delivered according to the manual for >95% of patients. More detailed evaluation of outcome was completed for the 198 patients with AD from these centers, who experienced a mean improvement of 6.6 points on the total CMAI (mean [SD], 62.2 [14.3] to 55.6 [15.8], t = 6.5, df = 197, p < 0.0001). Overall, 43% of participants achieved a 30% improvement in their level of agitation. The specific attributable benefits of BPST cannot be determined from an open trial. However, the BPST therapy was feasible and was successfully delivered according to an operationalized manual. The encouraging outcome indicates the need for a randomized controlled trial of BPST.

Tobacco dependence counseling in a randomized multisite clinical trial.

PubMed

Croghan, Ivana T; Trautman, Judith A; Winhusen, Theresa; Ebbert, Jon O; Kropp, Frankie B; Schroeder, Darrell R; Hurt, Richard D

2012-07-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. Copyright © 2012 Elsevier Inc. All rights reserved.

Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de). PMID:24884848

Environmental qualification testing of the prototype pool boiling experiment

NASA Technical Reports Server (NTRS)

Sexton, J. Andrew

1992-01-01

The prototype Pool Boiling Experiment (PBE) flew on the STS-47 mission in September 1992. This report describes the purpose of the experiment and the environmental qualification testing program that was used to prove the integrity of the prototype hardware. Component and box level vibration and thermal cycling tests were performed to give an early level of confidence in the hardware designs. At the system level, vibration, thermal extreme soaks, and thermal vacuum cycling tests were performed to qualify the complete design for the expected shuttle environment. The system level vibration testing included three axis sine sweeps and random inputs. The system level hot and cold soak tests demonstrated the hardware's capability to operate over a wide range of temperatures and gave the project team a wider latitude in determining which shuttle thermal altitudes were compatible with the experiment. The system level thermal vacuum cycling tests demonstrated the hardware's capability to operate in a convection free environment. A unique environmental chamber was designed and fabricated by the PBE team and allowed most of the environmental testing to be performed within the project's laboratory. The completion of the test program gave the project team high confidence in the hardware's ability to function as designed during flight.

Empowering and protecting children by enhancing knowledge, skills and well-being: A randomized trial of Learn to BE SAFE with Emmy.

PubMed

Dale, Rebecca; Shanley, Dianne C; Zimmer-Gembeck, Melanie J; Lines, Katrina; Pickering, Kaye; White, Codi

2016-01-01

Australia needs effective programs to protect children and prevent abuse, but there is little information available for policymakers or families. Using a randomized controlled trial, Learn to BE SAFE with Emmy, a school-based protection program for young children designed by Act for Kids, was evaluated to determine its effectiveness for promoting young children's knowledge and skills. Grade one children (n=245) from 15 classrooms across 5 primary schools completed assessment measures. A subset of these children received the program (n=131) or acted as a comparison group (n=114). Parents (n=72) completed questionnaires about their child's participation in the program. When compared with children who had not received the program, children who completed Learn to BE SAFE with Emmy demonstrated increased knowledge of interpersonal safety and were more likely to choose a safe response option to hypothetical unsafe scenarios 6 months after participation than at both pre- and post-intervention. Parents reported their children who participated used more safety strategies immediately and 6 months after participation compared to pre-intervention. Outcomes can assist in guiding future policies around the prevention of child abuse and protect the well-being of Australian children. Copyright © 2015 Elsevier Ltd. All rights reserved.

Acceptance of a pre-visit intervention to engage teens in pediatric asthma visits.

PubMed

Sleath, Betsy; Carpenter, Delesha M; Davis, Scott A; Watson, Claire Hayes; Lee, Charles; Loughlin, Ceila E; Garcia, Nacire; Etheridge, Dana; Rivera-Duchesne, Laura; Reuland, Daniel S; Batey, Karolyne; Duchesne, Cristina; Tudor, Gail

2017-11-01

The objectives of this study were to: (a) describe teen feedback on an asthma question prompt list/video intervention designed to motivate teens to be more engaged during visits and (b) examine teen demographics associated with teen acceptance of the intervention. Two hundred and fifty-nine teens ages 11 to 17 with persistent asthma were enrolled into a randomized, controlled trial and assigned to either a standard care or an intervention group where they watched an educational video with their parents and received a prompt list to complete before visits. Teens were interviewed after visits. Of the 185 teens randomized to the intervention group: 93% said teens should complete the prompt lists before visits; 95% recommended teens should watch the video before visits; teens with moderate/severe persistent asthma were significantly more likely to find the prompt list useful; non-White teens were significantly more likely to find the prompt list and video more useful. Teens exposed to the question prompt list/video had very positive feedback about the intervention. Providers/practices should consider having teens complete question prompt lists during pre-visit wait time for use during visits and watch the video with their parents before visits. Copyright © 2017 Elsevier B.V. All rights reserved.

Aripiprazole effects on self-administration and pharmacodynamics of intravenous cocaine and cigarette smoking in humans.

PubMed

Lofwall, Michelle R; Nuzzo, Paul A; Campbell, Charles; Walsh, Sharon L

2014-06-01

Aripiprazole is a partial agonist at dopamine (D2) and serotonin (5-HT1a) receptors and 5-HT2 antagonist. Because cocaine affects dopamine and serotonin, this study assessed whether aripiprazole could diminish the reinforcing efficacy of cocaine. Secondary aims evaluated aripiprazole on ad lib cigarette smoking and with a novel 40-hr smoking abstinence procedure. Adults with regular cocaine and cigarette use completed this inpatient double blind, randomized, placebo-controlled mixed-design study. A placebo lead-in was followed by randomization to aripiprazole (0, 2 or 10 mg/day/p.o.; n = 7 completed/group). Three sets of test sessions, each consisting of 3 cocaine sample-choice (i.e., self-administration) sessions and 1 dose-response session, were conducted (once during the lead-in and twice after randomization). Sample sessions tested each cocaine dose (0, 20 and 40 mg/70 kg, i.v.) in random order; subjective, observer-rated and physiologic outcomes were collected. Later that day, participants chose between the morning's sample dose or descending amounts of money over 7 trials. In dose response sessions, all doses were given 1 hr apart in ascending order for pharmacodynamic and pharmacokinetic assessment. Two sets of smoking topography sessions were conducted during the lead-in and after randomization; 1 with and 1 without 40 hr of smoking abstinence. Number of ad lib cigarettes smoked during non-session days was collected. Cocaine produced prototypic effects, but aripiprazole did not significantly alter these effects or smoking outcomes. The smoking abstinence procedure reliably produced nicotine withdrawal and craving and increased smoking modestly. These data do not support further investigation of aripiprazole for cocaine or tobacco use disorder treatment. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Respiratory Outcomes of the Surfactant Positive Pressure and Oximetry Randomized Trial

PubMed Central

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

2014-01-01

Objective To explore the early childhood pulmonary outcomes of infants who participated in the NICHD SUPPORT Trial, using a factorial design that randomized extremely preterm infants to lower vs. higher oxygen saturation targets and delivery room CPAP vs. intubation/surfactant, found no significant difference in the primary composite outcome of death or BPD. Study design The Breathing Outcomes Study, a prospective secondary to SUPPORT, assessed respiratory morbidity at 6 month intervals from hospital discharge to 18–22 months corrected age (CA). Two pre-specified primary outcomes, wheezing more than twice per week during the worst 2 week period and cough longer than 3 days without a cold were compared between each randomized intervention. Results One or more interviews were completed for 918 of 922 eligible infants. The incidence of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between study arms of either randomized intervention. Infants randomized to lower vs. higher oxygen saturation targets had similar risks of death or respiratory morbidities (except for croup, treatment with oxygen or diuretics at home). Infants randomized to CPAP vs. intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs. 36.5%, p<0.05), respiratory illnesses diagnosed by a doctor (47.7% vs. 55.2%, p<0.05) and physician or emergency room visits for breathing problems (68.0% vs. 72.9%, p<0.05) by 18–22 months CA. Conclusion Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18–22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates. PMID:24725582

Improving the evidence base in palliative care to inform practice and policy: thinking outside the box.

PubMed

Aoun, Samar M; Nekolaichuk, Cheryl

2014-12-01

The adoption of evidence-based hierarchies and research methods from other disciplines may not completely translate to complex palliative care settings. The heterogeneity of the palliative care population, complexity of clinical presentations, and fluctuating health states present significant research challenges. The aim of this narrative review was to explore the debate about the use of current evidence-based approaches for conducting research, such as randomized controlled trials and other study designs, in palliative care, and more specifically to (1) describe key myths about palliative care research; (2) highlight substantive challenges of conducting palliative care research, using case illustrations; and (3) propose specific strategies to address some of these challenges. Myths about research in palliative care revolve around evidence hierarchies, sample heterogeneity, random assignment, participant burden, and measurement issues. Challenges arise because of the complex physical, psychological, existential, and spiritual problems faced by patients, families, and service providers. These challenges can be organized according to six general domains: patient, system/organization, context/setting, study design, research team, and ethics. A number of approaches for dealing with challenges in conducting research fall into five separate domains: study design, sampling, conceptual, statistical, and measures and outcomes. Although randomized controlled trials have their place whenever possible, alternative designs may offer more feasible research protocols that can be successfully implemented in palliative care. Therefore, this article highlights "outside the box" approaches that would benefit both clinicians and researchers in the palliative care field. Ultimately, the selection of research designs is dependent on a clearly articulated research question, which drives the research process. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Adaptive Randomization of Veliparib-Carboplatin Treatment in Breast Cancer.

PubMed

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

2016-07-07

The genetic and clinical heterogeneity of breast cancer makes the identification of effective therapies challenging. We designed I-SPY 2, a phase 2, multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer. The goal is to match experimental regimens with responding cancer subtypes. We report results for veliparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, combined with carboplatin. In this ongoing trial, women are eligible for participation if they have stage II or III breast cancer with a tumor 2.5 cm or larger in diameter; cancers are categorized into eight biomarker subtypes on the basis of status with regard to human epidermal growth factor receptor 2 (HER2), hormone receptors, and a 70-gene assay. Patients undergo adaptive randomization within each biomarker subtype to receive regimens that have better performance than the standard therapy. Regimens are evaluated within 10 biomarker signatures (i.e., prospectively defined combinations of biomarker subtypes). Veliparib-carboplatin plus standard therapy was considered for HER2-negative tumors and was therefore evaluated in 3 signatures. The primary end point is pathological complete response. Tumor volume changes measured by magnetic resonance imaging during treatment are used to predict whether a patient will have a pathological complete response. Regimens move on from phase 2 if and when they have a high Bayesian predictive probability of success in a subsequent phase 3 neoadjuvant trial within the biomarker signature in which they performed well. With regard to triple-negative breast cancer, veliparib-carboplatin had an 88% predicted probability of success in a phase 3 trial. A total of 72 patients were randomly assigned to receive veliparib-carboplatin, and 44 patients were concurrently assigned to receive control therapy; at the completion of chemotherapy, the estimated rates of pathological complete response in the triple-negative population were 51% (95% Bayesian probability interval [PI], 36 to 66%) in the veliparib-carboplatin group versus 26% (95% PI, 9 to 43%) in the control group. The toxicity of veliparib-carboplatin was greater than that of the control. The process used in our trial showed that veliparib-carboplatin added to standard therapy resulted in higher rates of pathological complete response than standard therapy alone specifically in triple-negative breast cancer. (Funded by the QuantumLeap Healthcare Collaborative and others; I-SPY 2 TRIAL ClinicalTrials.gov number, NCT01042379.).

Report from a Multi-Institutional Randomized Clinical Trial Examining Computer-Assisted Problem-Solving Skills Training for English- and Spanish-Speaking Mothers of Children with Newly Diagnosed Cancer

PubMed Central

Sahler, Olle Jane Z.; Sherman, Sandra A.; Fairclough, Diane L.; Butler, Robert W.; Katz, Ernest R.; Dolgin, Michael J.; Varni, James W.; Noll, Robert B.; Phipps, Sean

2009-01-01

Objectives To evaluate the feasibility and efficacy of a handheld personal digital assistant (PDA)-based supplement for maternal Problem-Solving Skills Training (PSST) and to explore Spanish-speaking mothers’ experiences with it. Methods Mothers (n = 197) of children with newly diagnosed cancer were randomized to traditional PSST or PSST + PDA 8-week programs. Participants completed the Social Problem-Solving Inventory-Revised, Beck Depression Inventory-II, Profile of Mood States, and Impact of Event Scale-Revised pre-, post-treatment, and 3 months after completion of the intervention. Mothers also rated optimism, logic, and confidence in the intervention and technology. Results Both groups demonstrated significant positive change over time on all psychosocial measures. No between-group differences emerged. Despite technological “glitches,” mothers expressed moderately high optimism, appreciation for logic, and confidence in both interventions and rated the PDA-based program favorably. Technology appealed to all Spanish-speaking mothers, with younger mothers showing greater proficiency. Conclusions Well-designed, supported technology holds promise for enhancing psychological interventions. PMID:19091804

Disruption of Calcium Homeostasis during Exercise as a Mediator of Bone Metabolism

DTIC Science & Technology

2014-10-01

2013. We met the goal of having 14 women and 14 men complete EXP1. Progress on EXP1: Enrolled Screen Withdrew Randomized Withdrew Completed Failure...Before After Randomized Randomized Women 18 2 1 15 1 14 Men 22 2 3 17 3 14 Total 40 4 4 32 4 28 Reasons for withdrawals: Screening failures...Prepare annual progress report in Q4 This was accomplished. • Data from EXP1 As planned, 14 women and 14 men completed EXP1. The characteristics of

Gaze training enhances laparoscopic technical skill acquisition and multi-tasking performance: a randomized, controlled study.

PubMed

Wilson, Mark R; Vine, Samuel J; Bright, Elizabeth; Masters, Rich S W; Defriend, David; McGrath, John S

2011-12-01

The operating room environment is replete with stressors and distractions that increase the attention demands of what are already complex psychomotor procedures. Contemporary research in other fields (e.g., sport) has revealed that gaze training interventions may support the development of robust movement skills. This current study was designed to examine the utility of gaze training for technical laparoscopic skills and to test performance under multitasking conditions. Thirty medical trainees with no laparoscopic experience were divided randomly into one of three treatment groups: gaze trained (GAZE), movement trained (MOVE), and discovery learning/control (DISCOVERY). Participants were fitted with a Mobile Eye gaze registration system, which measures eye-line of gaze at 25 Hz. Training consisted of ten repetitions of the "eye-hand coordination" task from the LAP Mentor VR laparoscopic surgical simulator while receiving instruction and video feedback (specific to each treatment condition). After training, all participants completed a control test (designed to assess learning) and a multitasking transfer test, in which they completed the procedure while performing a concurrent tone counting task. Not only did the GAZE group learn more quickly than the MOVE and DISCOVERY groups (faster completion times in the control test), but the performance difference was even more pronounced when multitasking. Differences in gaze control (target locking fixations), rather than tool movement measures (tool path length), underpinned this performance advantage for GAZE training. These results suggest that although the GAZE intervention focused on training gaze behavior only, there were indirect benefits for movement behaviors and performance efficiency. Additionally, focusing on a single external target when learning, rather than on complex movement patterns, may have freed-up attentional resources that could be applied to concurrent cognitive tasks.

Do Published Data in Trials Assessing Cancer Drugs Reflect the Real Picture of Efficacy and Safety?

PubMed

Lv, Jia-Wei; Chen, Yu-Pei; Zhou, Guan-Qun; Liu, Xu; Guo, Ying; Mao, Yan-Ping; Ma, Jun; Sun, Ying

2017-11-01

Background: The reporting quality of publications is of vital importance to ensure accurate evidence dissemination. This study aimed to compare the consistency of results reporting between the ClinicalTrials.gov results database and the respective matching publications. Methods: We identified 323 phase III/IV cancer drug trials with a randomized controlled design and searched PubMed for publications in a 50% random sample (n=160). Data were extracted independently from ClinicalTrials.gov and publications. A scoring system was applied to determine characteristics associated with reporting quality. Results: Of 117 reviewed trials with publications, result reporting was significantly more complete in ClinicalTrials.gov for efficacy measurement (92.3% vs 90.6%), serious adverse events (SAEs; 100% vs 43.6%), and other adverse events (OAEs; 100% vs 62.4%). For trials with both posted and published results for design information (n=117), efficacy measurements (n=98), SAEs (n=51), and OAEs (n=73), discrepancies were found in 16 (13.7%), 38 (38.8%), 26 (51.0%), and 54 (74.0%) trials, respectively. Overreporting of treatment effects (7 trials) and alteration of primary end points favoring statistically significant outcomes (11 trials) were the major discrepancies in efficacy reporting; incomplete (66 trials) and underreporting (20 trials) of SAEs were the predominant issues in benefit/risk reporting. Median quality score was 21 (range, 14-28). Trials that had parallel assignment, were phase IV, had primary funding by industry, were completed after 2009, and had earlier results posted possessed better reporting quality. Conclusions: Although most trials showed reasonable completeness and consistency, some discrepancies are prevalent and persistent, jeopardizing evidence-based decision-making. Our findings highlight the need to consult results systematically from both ClinicalTrials.gov and publications. Copyright © 2017 by the National Comprehensive Cancer Network.

Block randomization versus complete randomization of human perception stimuli: is there a difference?

NASA Astrophysics Data System (ADS)

Moyer, Steve; Uhl, Elizabeth R.

2015-05-01

For more than 50 years, the U.S. Army RDECOM CERDEC Night Vision and Electronic Sensors Directorate (NVESD) has been studying and modeling the human visual discrimination process as it pertains to military imaging systems. In order to develop sensor performance models, human observers are trained to expert levels in the identification of military vehicles. From 1998 until 2006, the experimental stimuli were block randomized, meaning that stimuli with similar difficulty levels (for example, in terms of distance from target, blur, noise, etc.) were presented together in blocks of approximately 24 images but the order of images within the block was random. Starting in 2006, complete randomization came into vogue, meaning that difficulty could change image to image. It was thought that this would provide a more statistically robust result. In this study we investigated the impact of the two types of randomization on performance in two groups of observers matched for skill to create equivalent groups. It is hypothesized that Soldiers in the Complete Randomized condition will have to shift their decision criterion more frequently than Soldiers in the Block Randomization group and this shifting is expected to impede performance so that Soldiers in the Block Randomized group perform better.

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

PubMed Central

Wiljer, David; Cafazzo, Joseph A

2016-01-01

Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study duration than trials with two data collection points: F4,56=3.2, P=.021, η2=0.18. Single-blinded trials had a longer data collection period compared to open trials: F2,58=3.8, P=.028, η2=0.12. Academic sponsorship was the most common form of trial funding (73%, 52/71). Trials with academic sponsorship had a longer study duration compared to industry sponsorship: F2,61=3.7, P=.030, η2=0.11. Combined, data collection frequency, study masking, sample size, and study sponsorship accounted for 32.6% of the variance in study duration: F4,55=6.6, P<.01, adjusted r2=.33. Only 7 trials had been completed at the time this retrospective review was conducted (10%, 7/71). Conclusions mHealth evaluation methodology has not deviated from common methods, despite the need for more relevant and timely evaluations. There is a need for clinical evaluation to keep pace with the level of innovation of mHealth if it is to have meaningful impact in informing payers, providers, policy makers, and patients. PMID:27613084

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

PubMed

Pham, Quynh; Wiljer, David; Cafazzo, Joseph A

2016-09-09

Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study duration than trials with two data collection points: F4,56=3.2, P=.021, η(2)=0.18. Single-blinded trials had a longer data collection period compared to open trials: F2,58=3.8, P=.028, η(2)=0.12. Academic sponsorship was the most common form of trial funding (73%, 52/71). Trials with academic sponsorship had a longer study duration compared to industry sponsorship: F2,61=3.7, P=.030, η(2)=0.11. Combined, data collection frequency, study masking, sample size, and study sponsorship accounted for 32.6% of the variance in study duration: F4,55=6.6, P<.01, adjusted r(2)=.33. Only 7 trials had been completed at the time this retrospective review was conducted (10%, 7/71). mHealth evaluation methodology has not deviated from common methods, despite the need for more relevant and timely evaluations. There is a need for clinical evaluation to keep pace with the level of innovation of mHealth if it is to have meaningful impact in informing payers, providers, policy makers, and patients.

A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

PubMed

Koethe, John R; Westfall, Andrew O; Luhanga, Dora K; Clark, Gina M; Goldman, Jason D; Mulenga, Priscilla L; Cantrell, Ronald A; Chi, Benjamin H; Zulu, Isaac; Saag, Michael S; Stringer, Jeffrey S A

2010-03-12

The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree). Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. Clinicaltrials.gov NCT00929604.

Increased statistical power with combined independent randomization tests used with multiple-baseline design.

PubMed

Tyrrell, Pascal N; Corey, Paul N; Feldman, Brian M; Silverman, Earl D

2013-06-01

Physicians often assess the effectiveness of treatments on a small number of patients. Multiple-baseline designs (MBDs), based on the Wampold-Worsham (WW) method of randomization and applied to four subjects, have relatively low power. Our objective was to propose another approach with greater power that does not suffer from the time requirements of the WW method applied to a greater number of subjects. The power of a design that involves the combination of two four-subject MBDs was estimated using computer simulation and compared with the four- and eight-subject designs. The effect of a delayed linear response to treatment on the power of the test was also investigated. Power was found to be adequate (>80%) for a standardized mean difference (SMD) greater than 0.8. The effect size associated with 80% power from combined tests was smaller than that of the single four-subject MBD (SMD=1.3) and comparable with the eight-subject MBD (SMD=0.6). A delayed linear response to the treatment resulted in important reductions in power (20-35%). By combining two four-subject MBD tests, an investigator can detect better effect sizes (SMD=0.8) and be able to complete a comparatively timelier and feasible study. Copyright © 2013 Elsevier Inc. All rights reserved.

Influence function based variance estimation and missing data issues in case-cohort studies.

PubMed

Mark, S D; Katki, H

2001-12-01

Recognizing that the efficiency in relative risk estimation for the Cox proportional hazards model is largely constrained by the total number of cases, Prentice (1986) proposed the case-cohort design in which covariates are measured on all cases and on a random sample of the cohort. Subsequent to Prentice, other methods of estimation and sampling have been proposed for these designs. We formalize an approach to variance estimation suggested by Barlow (1994), and derive a robust variance estimator based on the influence function. We consider the applicability of the variance estimator to all the proposed case-cohort estimators, and derive the influence function when known sampling probabilities in the estimators are replaced by observed sampling fractions. We discuss the modifications required when cases are missing covariate information. The missingness may occur by chance, and be completely at random; or may occur as part of the sampling design, and depend upon other observed covariates. We provide an adaptation of S-plus code that allows estimating influence function variances in the presence of such missing covariates. Using examples from our current case-cohort studies on esophageal and gastric cancer, we illustrate how our results our useful in solving design and analytic issues that arise in practice.

Metadisorder for designer light in random systems

PubMed Central

Yu, Sunkyu; Piao, Xianji; Hong, Jiho; Park, Namkyoo

2016-01-01

Disorder plays a critical role in signal transport by controlling the correlation of a system, as demonstrated in various complex networks. In wave physics, disordered potentials suppress wave transport, because of their localized eigenstates, from the interference between multiple scattering paths. Although the variation of localization with tunable disorder has been intensively studied as a bridge between ordered and disordered media, the general trend of disorder-enhanced localization has remained unchanged, and the existence of complete delocalization in highly disordered potentials has not been explored. We propose the concept of “metadisorder”: randomly coupled optical systems in which eigenstates can be engineered to achieve unusual localization. We demonstrate that one of the eigenstates in a randomly coupled system can always be arbitrarily molded, regardless of the degree of disorder, by adjusting the self-energy of each element. Ordered waves with the desired form are then achieved in randomly coupled systems, including plane waves and globally collective resonances. We also devise counterintuitive functionalities in disordered systems, such as “small-world–like” transport from non–Anderson-type localization, phase-conserving disorder, and phase-controlled beam steering. PMID:27757414

Patient and program factors that bridge the detoxification-treatment gap: a structured evidence review.

PubMed

Timko, Christine; Below, Maureen; Schultz, Nicole R; Brief, Deborah; Cucciare, Michael A

2015-05-01

Although completion of detoxification (detox) and a successful transition from detox to substance use disorder (SUD) treatment and/or mutual-help groups are associated with better SUD outcomes, many patients do not complete detox or do not receive SUD care following detox. The purpose of this structured evidence review, summarizing data extraction on a yield of 26 articles, is to identify patient, program, and system factors associated with the outcomes of completion of alcohol detox and successful transitions from alcohol detox to SUD treatment and mutual-help group participation. The review found wide variability among studies in the rates at which patients complete a detox episode (45 to 95%) and enter SUD treatment or mutual-help groups after detox (14 to 92%). Within program factors, behavioral practices that contribute to both detox completion and transitioning to SUD care after detox entail involving the patient's family and utilizing motivational-based approaches. Such practices should be targeted at younger patients, who are less likely to complete detox. Although more studies using a randomized controlled trial design are needed, the evidence suggests that barriers to detox completion and transition to SUD care can be overcome to improve patient outcomes. Published by Elsevier Inc.

Transpiration rates of rice plants treated with Trichoderma spp.

NASA Astrophysics Data System (ADS)

Doni, Febri; Anizan, I.; Che Radziah C. M., Z.; Yusoff, Wan Mohtar Wan

2014-09-01

Trichoderma spp. are considered as successful plant growth promoting fungi and have positive role in habitat engineering. In this study, the potential for Trichoderma spp. to regulate transpiration process in rice plant was assessed experimentally under greenhouse condition using a completely randomized design. The study revealed that Trichoderma spp. have potential to enhance growth of rice plant through transpirational processes. The results of the study add to the advancement of the understanding as to the role of Trichoderma spp. in improving rice physiological process.

Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

PubMed

Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

2017-01-01

Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.

Design, methods, and baseline characteristics of the Kids’ Health Insurance by Educating Lots of Parents (Kids’ HELP) trial: A randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children✰

PubMed Central

Flores, Glenn; Walker, Candy; Lin, Hua; Lee, Michael; Fierro, Marco; Henry, Monica; Massey, Kenneth; Portillo, Alberto

2014-01-01

Background & objectives Six million US children have no health insurance, and substantial racial/ethnic disparities exist. The design, methods, and baseline characteristics are described for Kids’ Health Insurance by Educating Lots of Parents (Kids’ HELP), the first randomized, clinical trial of the effectiveness of Parent Mentors (PMs) in insuring uninsured minority children. Methods & research design Latino and African-American children eligible for but not enrolled in Medicaid/CHIP were randomized to PMs, or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents with ≥ 1 Medicaid/CHIP-covered children. PMs received two days of training, and provide intervention families with information on Medicaid/CHIP eligibility, assistance with application submission, and help maintaining coverage. Primary outcomes include obtaining health insurance, time interval to obtain coverage, and parental satisfaction. A blinded assessor contacts subjects monthly for one year to monitor outcomes. Results Of 49,361 candidates screened, 329 fulfilled eligibility criteria and were randomized. The mean age is seven years for children and 32 years for caregivers; 2/3 are Latino, 1/3 are African-American, and the mean annual family income is $21,857. Half of caregivers were unaware that their uninsured child is Medicaid/CHIP eligible, and 95% of uninsured children had prior insurance. Fifteen PMs completed two-day training sessions. All PMs are female and minority, 60% are unemployed, and the mean annual family income is $20,913. Post-PM-training, overall knowledge/skills test scores significantly increased, and 100% reported being very satisfied/satisfied with the training. Conclusions Kids’ HELP successfully reached target populations, met participant enrollment goals, and recruited and trained PMs. PMID:25476583

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

PubMed

Bowers, Alex R; Keeney, Karen; Peli, Eli

2014-02-01

There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition. To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia. Double-masked, randomized crossover trial at 13 study sites, including the Peli laboratory at Schepens Eye Research Institute, 11 vision rehabilitation clinics in the United States, and 1 in the United Kingdom. Patients were 18 years or older with complete homonymous hemianopia for at least 3 months and without visual neglect or significant cognitive decline. Patients were allocated by minimization into 2 groups. One group received real (57-prism diopter) oblique and sham (<5-prism diopter) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. Each crossover period was 4 weeks. The primary outcome was the overall difference, across the 2 periods of the crossover, between the proportion of participants who wanted to continue with (said yes to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs 36%; odds ratio, 5.3; 95% CI, 1.8-21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (P = .002); participants who discontinued wear reported no difference. Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. clinicaltrials.gov Identifier: NCT00494676.

Improving data sharing in research with context-free encoded missing data.

PubMed

Hoevenaar-Blom, Marieke P; Guillemont, Juliette; Ngandu, Tiia; Beishuizen, Cathrien R L; Coley, Nicola; Moll van Charante, Eric P; Andrieu, Sandrine; Kivipelto, Miia; Soininen, Hilkka; Brayne, Carol; Meiller, Yannick; Richard, Edo

2017-01-01

Lack of attention to missing data in research may result in biased results, loss of power and reduced generalizability. Registering reasons for missing values at the time of data collection, or-in the case of sharing existing data-before making data available to other teams, can save time and efforts, improve scientific value and help to prevent erroneous assumptions and biased results. To ensure that encoding of missing data is sufficient to understand the reason why data are missing, it should ideally be context-free. Therefore, 11 context-free codes of missing data were carefully designed based on three completed randomized controlled clinical trials and tested in a new randomized controlled clinical trial by an international team consisting of clinical researchers and epidemiologists with extended experience in designing and conducting trials and an Information System expert. These codes can be divided into missing due to participant and/or participation characteristics (n = 6), missing by design (n = 4), and due to a procedural error (n = 1). Broad implementation of context-free missing data encoding may enhance the possibilities of data sharing and pooling, thus allowing more powerful analyses using existing data.

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

PubMed

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

2011-10-01

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

Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol.

PubMed

Gibson, Dustin G; Pariyo, George William; Wosu, Adaeze C; Greenleaf, Abigail R; Ali, Joseph; Ahmed, Saifuddin; Labrique, Alain B; Islam, Khaleda; Masanja, Honorati; Rutebemberwa, Elizeus; Hyder, Adnan A

2017-05-05

Mobile phone ownership and access have increased rapidly across low- and middle-income countries (LMICs) within the last decade. Concomitantly, LMICs are experiencing demographic and epidemiologic transitions, where non-communicable diseases (NCDs) are increasingly becoming leading causes of morbidity and mortality. Mobile phone surveys could aid data collection for prevention and control of these NCDs but limited evidence of their feasibility exists. The objective of this paper is to describe a series of sub-studies aimed at optimizing the delivery of interactive voice response (IVR) and computer-assisted telephone interviews (CATI) for NCD risk factor data collection in LMICs. These sub-studies are designed to assess the effect of factors such as airtime incentive timing, amount, and structure, survey introduction characteristics, different sampling frames, and survey modality on key survey metrics, such as survey response, completion, and attrition rates. In a series of sub-studies, participants will be randomly assigned to receive different airtime incentive amounts (eg, 10 minutes of airtime versus 20 minutes of airtime), different incentive delivery timings (airtime delivered before survey begins versus delivery upon completion of survey), different survey introductions (informational versus motivational), different narrative voices (male versus female), and different sampling frames (random digit dialing versus mobile network operator-provided numbers) to examine which study arms will yield the highest response and completion rates. Furthermore, response and completion rates and the inter-modal reliability of the IVR and CATI delivery methods will be compared. Research activities are expected to be completed in Bangladesh, Tanzania, and Uganda in 2017. This is one of the first studies to examine the feasibility of using IVR and CATI for systematic collection of NCD risk factor information in LMICs. Our findings will inform the future design and implementation of mobile phone surveys in LMICs. ©Dustin G Gibson, George William Pariyo, Adaeze C Wosu, Abigail R Greenleaf, Joseph Ali, Saifuddin Ahmed, Alain B Labrique, Khaleda Islam, Honorati Masanja, Elizeus Rutebemberwa, Adnan A Hyder. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.05.2017.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative.

PubMed

Barchi, Francis H; Kasimatis-Singleton, Megan; Kasule, Mary; Khulumani, Pilate; Merz, Jon F

2013-02-01

Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

PubMed Central

2013-01-01

Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate. PMID:23368699

The reliability of a VISION COACH task as a measure of psychomotor skills.

PubMed

Xi, Yubin; Rosopa, Patrick J; Mossey, Mary; Crisler, Matthew C; Drouin, Nathalie; Kopera, Kevin; Brooks, Johnell O

2014-10-01

The VISION COACH™ interactive light board is designed to test and enhance participants' psychomotor skills. The primary goal of this study was to examine the test-retest reliability of the Full Field 120 VISION COACH task. One hundred eleven male and 131 female adult participants completed six trials where they responded to 120 randomly distributed lights displayed on the VISION COACH interactive light board. The mean time required for a participant to complete a trial was 101 seconds. Intraclass correlation coefficients, ranging from 0.962 to 0.987 suggest the VISION COACH Full Field 120 task was a reliable task. Cohen's d's of adjacent pairs of trials suggest learning effects did not negatively affect reliability after the third trial.

MDC-Analyzer: a novel degenerate primer design tool for the construction of intelligent mutagenesis libraries with contiguous sites.

PubMed

Tang, Lixia; Wang, Xiong; Ru, Beibei; Sun, Hengfei; Huang, Jian; Gao, Hui

2014-06-01

Recent computational and bioinformatics advances have enabled the efficient creation of novel biocatalysts by reducing amino acid variability at hot spot regions. To further expand the utility of this strategy, we present here a tool called Multi-site Degenerate Codon Analyzer (MDC-Analyzer) for the automated design of intelligent mutagenesis libraries that can completely cover user-defined randomized sequences, especially when multiple contiguous and/or adjacent sites are targeted. By initially defining an objective function, the possible optimal degenerate PCR primer profiles could be automatically explored using the heuristic approach of Greedy Best-First-Search. Compared to the previously developed DC-Analyzer, MDC-Analyzer allows for the existence of a small amount of undesired sequences as a tradeoff between the number of degenerate primers and the encoded library size while still providing all the benefits of DC-Analyzer with the ability to randomize multiple contiguous sites. MDC-Analyzer was validated using a series of randomly generated mutation schemes and experimental case studies on the evolution of halohydrin dehalogenase, which proved that the MDC methodology is more efficient than other methods and is particularly well-suited to exploring the sequence space of proteins using data-driven protein engineering strategies.

The effect of ergonomic laparoscopic tool handle design on performance and efficiency.

PubMed

Tung, Kryztopher D; Shorti, Rami M; Downey, Earl C; Bloswick, Donald S; Merryweather, Andrew S

2015-09-01

Many factors can affect a surgeon's performance in the operating room; these may include surgeon comfort, ergonomics of tool handle design, and fatigue. A laparoscopic tool handle designed with ergonomic considerations (pistol grip) was tested against a current market tool with a traditional pinch grip handle. The goal of this study is to quantify the impact ergonomic design considerations which have on surgeon performance. We hypothesized that there will be measurable differences between the efficiency while performing FLS surgical trainer tasks when using both tool handle designs in three categories: time to completion, technical skill, and subjective user ratings. The pistol grip incorporates an ergonomic interface intended to reduce contact stress points on the hand and fingers, promote a more neutral operating wrist posture, and reduce hand tremor and fatigue. The traditional pinch grip is a laparoscopic tool developed by Stryker Inc. widely used during minimal invasive surgery. Twenty-three (13 M, 10 F) participants with no existing upper extremity musculoskeletal disorders or experience performing laparoscopic procedures were selected to perform in this study. During a training session prior to testing, participants performed practice trials in a SAGES FLS trainer with both tools. During data collection, participants performed three evaluation tasks using both handle designs (order was randomized, and each trial completed three times). The tasks consisted of FLS peg transfer, cutting, and suturing tasks. Feedback from test participants indicated that they significantly preferred the ergonomic pistol grip in every category (p < 0.05); most notably, participants experienced greater degrees of discomfort in their hands after using the pinch grip tool. Furthermore, participants completed cutting and peg transfer tasks in a shorter time duration (p < 0.05) with the pistol grip than with the pinch grip design; there was no significant difference between completion times for the suturing task. Finally, there was no significant interaction between tool type and errors made during trials. There was a significant preference for as well as lower pain experienced during use of the pistol grip tool as seen from the survey feedback. Both evaluation tasks (cutting and peg transfer) were also completed significantly faster with the pistol grip tool. Finally, due to the high degree of variability in the error data, it was not possible to draw any meaningful conclusions about the effect of tool design on the number or degree of errors made.

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Isotonic designs for phase I trials in partially ordered groups.

PubMed

Conaway, Mark

2017-10-01

Dose-finding trials can be conducted such that patients are first stratified into multiple risk groups before doses are allocated. The risk groups are often completely ordered in that, for a fixed dose, the probability of toxicity is monotonically increasing across groups. In some trials, the groups are only partially ordered. For example, one of several groups in a trial may be known to have the least risk of toxicity for a given dose, but the ordering of the risk among the remaining groups may not be known. The aim of the article is to introduce a method for designing dose-finding trials of cytotoxic agents in completely or partially ordered groups of patients. This article presents a method for dose-finding that combines previously proposed mathematical models, augmented with results using order restricted inference. The resulting method is computationally convenient and allows for dose-finding in trials with completely or partially ordered groups. Extensive simulations are done to evaluate the performance of the method, using randomly generated dose-toxicity curves where, within each group, the risk of toxicity is an increasing function of dose. Our simulations show that the hybrid method, in which order-restricted estimation is applied to parameters of a parsimonious mathematical model, gives results that are similar to previously proposed methods for completely ordered groups. Our method generalizes to a wide range of partial orders among the groups. The problem of dose-finding in partially ordered groups has not been extensively studied in the statistical literature. The proposed method is computationally feasible, and provides a potential solution to the design of dose-finding studies in completely or partially ordered groups.

Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Function, and Quality of Life in Fibromyalgia: A Double-Blind Randomized Clinical Trial

PubMed Central

Noehren, Brian; Dailey, Dana L.; Rakel, Barbara A.; Vance, Carol G.T.; Zimmerman, Miriam B.; Crofford, Leslie J.

2015-01-01

Background Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia. Objectives The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia. Design This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial. Participants Three hundred forty-three participants with fibromyalgia will be recruited for this study. Intervention Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity. Measurements The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing. Limitations Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded. Conclusions The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia. PMID:25212518

A randomized controlled trial to evaluate the Make Safe Happen® app-a mobile technology-based safety behavior change intervention for increasing parents' safety knowledge and actions.

PubMed

McKenzie, Lara B; Roberts, Kristin J; Clark, Roxanne; McAdams, Rebecca; Abdel-Rasoul, Mahmoud; Klein, Elizabeth G; Keim, Sarah A; Kristel, Orie; Szymanski, Alison; Cotton, Christopher G; Shields, Wendy C

2018-03-12

Many unintentional injuries that occur in and around the home can be prevented through the use of safety equipment and by consistently following existing safety recommendations. Unfortunately, uptake of these safety behaviors is unacceptably low. This paper describes the design of the Make Safe Happen® smartphone application evaluation study, which aims to evaluate a mobile technology-based safety behavior change intervention on parents' safety knowledge and actions. Make Safe Happen® app evaluation study is a randomized controlled trial. Participants will be parents of children aged 0-12 years who are recruited from national consumer online survey panels. Parents will complete a pretest survey, and will be randomized to receive the Make Safe Happen® app or a non-injury-related app, and then complete a posttest follow-up survey after 1 week. Primary outcomes are: (1) safety knowledge; (2) safety behaviors; (3) safety device acquisition and use, and (4) behavioral intention to take safety actions. Anticipated study results are presented. Wide-reaching interventions, to reach substantial parent and caregiver audiences, to effectively reduce childhood injuries are needed. This study will contribute to the evidence-base about how to increase safety knowledge and actions to prevent home-related injuries in children. NCT02751203 ; Pre-results.

A randomized controlled trial to enhance coping and posttraumatic growth and decrease posttraumatic stress disorder in HIV-Infected men who have sex with men in Beijing, China.

PubMed

Ye, Zhi; Yu, Nancy Xiaonan; Zhu, Wanling; Chen, Lihua; Lin, Danhua

2018-06-01

Although HIV-infected men who have sex with men (MSM) constitute a newly emerged high-risk group in China, little research outside Western countries is available on effective intervention programs to enhance their well-being. The purpose of this randomized controlled trial was to evaluate the efficacy of a group intervention program designed to improve the well-being and adaptive coping strategies of 60 HIV-infected MSM in Beijing, China, randomly assigned either to the intervention group for participation in four weekly sessions or to the control group for placement on a waiting list. They all completed measurements at pre- and postintervention. Compared with the control group, the intervention group reported significantly increased problem-focused coping strategies and levels of posttraumatic growth (PTG) as well as decreased symptoms of posttraumatic stress disorder (PTSD) at the completion of the intervention. In addition, mediation analysis showed that changes in problem-focused coping strategies mediated the intervention effect on increases in PTG; however, the mediating effect of coping strategies on the association of intervention and PTSD was not significant. This study provides empirical evidence for conducting psychological intervention to promote the well-being of HIV-infected MSM. The findings also elucidate the mechanism through which intervention improved PTG.

Animated Randomness, Avatars, Movement, and Personalization in Risk Graphics

PubMed Central

Fuhrel-Forbis, Andrea; Wijeysundera, Harindra C; Exe, Nicole; Dickson, Mark; Holtzman, Lisa; Kahn, Valerie C; Zikmund-Fisher, Brian J

2014-01-01

Background Risk communication involves conveying two inherently difficult concepts about the nature of risk: the underlying random distribution of outcomes and how a population-based proportion applies to an individual. Objective The objective of this study was to test whether 4 design factors in icon arrays—animated random dispersal of risk events, avatars to represent an individual, personalization (operationalized as choosing the avatar’s color), and a moving avatar—might help convey randomness and how a given risk applies to an individual, thereby better aligning risk perceptions with risk estimates. Methods A diverse sample of 3630 adults with no previous heart disease or stroke completed an online nested factorial experiment in which they entered personal health data into a risk calculator that estimated 10-year risk of cardiovascular disease based on a robust and validated model. We randomly assigned them to view their results in 1 of 10 risk graphics that used different combinations of the 4 design factors. We measured participants’ risk perceptions as our primary outcome, as well as behavioral intentions and recall of the risk estimate. We also assessed subjective numeracy, whether or not participants knew anyone who had died of cardiovascular causes, and whether or not they knew their blood pressure and cholesterol as potential moderators. Results Animated randomness was associated with better alignment between risk estimates and risk perceptions (F 1,3576=6.12, P=.01); however, it also led to lower scores on healthy lifestyle intentions (F 1,3572=11.1, P<.001). Using an avatar increased risk perceptions overall (F 1,3576=4.61, P=.03) and most significantly increased risk perceptions among those who did not know a particular person who had experienced the grave outcomes of cardiovascular disease (F 1,3576=5.88, P=.02). Using an avatar also better aligned actual risk estimates with intentions to see a doctor (F 1,3556=6.38, P=.01). No design factors had main effects on recall, but animated randomness was associated with better recall for those at lower risk and worse recall for those at higher risk (F 1,3544=7.06, P=.01). Conclusions Animated randomness may help people better understand the random nature of risk. However, in the context of cardiovascular risk, such understanding may result in lower healthy lifestyle intentions. Therefore, whether or not to display randomness may depend on whether one’s goal is to persuade or to inform. Avatars show promise for helping people grasp how population-based statistics map to an individual case. PMID:24642037

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

PubMed Central

2009-01-01

Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires. Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651 PMID:19954550

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.

PubMed

Krist, Alex H; Glenn, Beth A; Glasgow, Russell E; Balasubramanian, Bijal A; Chambers, David A; Fernandez, Maria E; Heurtin-Roberts, Suzanne; Kessler, Rodger; Ory, Marcia G; Phillips, Siobhan M; Ritzwoller, Debra P; Roby, Dylan H; Rodriguez, Hector P; Sabo, Roy T; Sheinfeld Gorin, Sherri N; Stange, Kurt C

2013-06-25

There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. Clinicaltrials.gov: NCT01825746.

A comparative study of grasping-type scissors forceps and insulated-tip knife for endoscopic submucosal dissection of early gastric cancer: a randomized controlled trial

PubMed Central

Nagai, Kengo; Uedo, Noriya; Yamashina, Takeshi; Matsui, Fumi; Matsuura, Noriko; Ito, Takashi; Yamamoto, Sachiko; Hanaoka, Noboru; Takeuchi, Yoji; Higashino, Koji; Ishihara, Ryu; Iishi, Hiroyasu

2016-01-01

Background and study aims: Endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is technically difficult for beginners. Few comparative studies of technical feasibility, efficacy, and safety using various devices have been reported. This study evaluated the feasibility, efficacy, and safety of ESD for EGC < 2 cm using grasping-type scissors forceps (GSF) or insulated-tip knife (IT2) for three resident endoscopists. Patients and methods: This was a randomized phase II study in a cancer referral center. A total of 108 patients with 120 EGCs were enrolled with the following characteristics: differentiated-type mucosal EGC, without ulcers or scars, < 2 cm (86 men, 22 women; median age 72 years). All lesions were stratified according to operator and tumor location (antrum or corpus), assigned randomly to two groups (GSF or IT2), and resected by ESD. Self-completion rate, complete resection rate, procedure time, and adverse events were evaluated as main outcome measures. Results: There was no difference in self-completion rate between the IT2 group (77 %, 47/61, P = 0.187) and the GSF group (66 %, 37/56). Also, there were no differences in en bloc resection rate (98 %, 60/61 vs. 93 %, 52/56, P = 0.195) and adverse events (3.3 %, 2/61 vs. 7.1 %, 4/56, P = 0.424). Median (min [range]) procedure time in the IT2 group (47 [33 – 67], P = 0.003) was shorter than that in the GSF group (66 [40 – 100]). Limitations of this study were the small sample size and single center design. Conclusions: ESD with GSF did not show a statistically significant advantage in improvement of self-completion rate over IT2. (Study registration: UMIN 000005048) PMID:27556074

Open-Label, Randomized, Parallel-Group Controlled Clinical Trial of Massage for Treatment of Depression in HIV-Infected Subjects

PubMed Central

Gertsik, Lev; Favreau, Joya T.; Smith, Shawnee I.; Mirocha, James M.; Rao, Uma; Daar, Eric S.

2013-01-01

Abstract Objectives The study objectives were to determine whether massage therapy reduces symptoms of depression in subjects with human immunodeficiency virus (HIV) disease. Design Subjects were randomized non-blinded into one of three parallel groups to receive Swedish massage or to one of two control groups, touch or no intervention for eight weeks. Settings/location The study was conducted at the Department of Psychiatry and Behavioral Neurosciences at Cedars-Sinai Medical Center in Los Angeles, California, which provided primary clinical care in an institutional setting. Subjects Study inclusion required being at least 16 years of age, HIV-seropositive, with a diagnosis of major depressive disorder. Subjects had to be on a stable neuropsychiatric, analgesic, and antiretroviral regimen for >30 days with no plans to modify therapy for the duration of the study. Approximately 40% of the subjects were currently taking antidepressants. All subjects were medically stable. Fifty-four (54) subjects were randomized, 50 completed at least 1 week (intent-to-treat; ITT), and 37 completed the study (completers). Interventions Swedish massage and touch subjects visited the massage therapist for 1 hour twice per week. The touch group had a massage therapist place both hands on the subject with slight pressure, but no massage, in a uniform distribution in the same pattern used for the massage subjects. Outcome measures The primary outcome measure was the Hamilton Rating Scale for Depression score, with the secondary outcome measure being the Beck Depression Inventory. Results For both the ITT and completers analyses, massage significantly reduced the severity of depression beginning at week 4 (p≤0.04) and continuing at weeks 6 (p≤0.03) and 8 (p≤0.005) compared to no intervention and/or touch. Conclusions The results indicate that massage therapy can reduce symptoms of depression in subjects with HIV disease. The durability of the response, optimal “dose” of massage, and mechanisms by which massage exerts its antidepressant effects remain to be determined. PMID:23098696

The Statistical Power of the Cluster Randomized Block Design with Matched Pairs--A Simulation Study

ERIC Educational Resources Information Center

Dong, Nianbo; Lipsey, Mark

2010-01-01

This study uses simulation techniques to examine the statistical power of the group- randomized design and the matched-pair (MP) randomized block design under various parameter combinations. Both nearest neighbor matching and random matching are used for the MP design. The power of each design for any parameter combination was calculated from…

A randomized clinical trial of an intervention to promote resilience in young children of HIV-positive mothers in South Africa.

PubMed

Eloff, Irma; Finestone, Michelle; Makin, Jennifer D; Boeving-Allen, Alex; Visser, Maretha; Ebersöhn, Liesel; Ferreira, Ronél; Sikkema, Kathleen J; Briggs-Gowan, Margaret J; Forsyth, Brian W C

2014-07-01

The objective of this study is to assess the efficacy of an intervention designed to promote resilience in young children living with their HIV-positive mothers. HIV-positive women attending clinics in Tshwane, South Africa, and their children, aged 6-10 years, were randomized to the intervention (I) or standard care (S). The intervention consisted of 24 weekly group sessions led by community care workers. Mothers and children were in separate groups for 14 sessions, followed by 10 interactive sessions. The primary focus was on parent-child communication and parenting. Assessments were completed by mothers and children at baseline and 6, 12 and 18 months. Repeated mixed linear analyses were used to assess change over time. Of 390 mother-child pairs, 84.6% (I: 161 and S: 169) completed at least two interviews and were included in the analyses. Children's mean age was 8.4 years and 42% of mothers had been ill in the prior 3 months. Attendance in groups was variable: only 45.7% attended more than 16 sessions. Intervention mothers reported significant improvements in children's externalizing behaviours (ß = -2.8, P = 0.002), communication (ß = 4.3, P = 0.025) and daily living skills (ß = 5.9, P = 0.024), although improvement in internalizing behaviours and socialization was not significant (P = 0.061 and 0.052, respectively). Intervention children reported a temporary increase in anxiety but did not report differences in depression or emotional intelligence. This is the first study demonstrating benefits of an intervention designed to promote resilience among young children of HIV-positive mothers. The intervention was specifically designed for an African context and has the potential to benefit large numbers of children, if it can be widely implemented.

The "Interval Walking in Colorectal Cancer" (I-WALK-CRC) study: Design, methods and recruitment results of a randomized controlled feasibility trial.

PubMed

Banck-Petersen, Anna; Olsen, Cecilie K; Djurhuus, Sissal S; Herrstedt, Anita; Thorsen-Streit, Sarah; Ried-Larsen, Mathias; Østerlind, Kell; Osterkamp, Jens; Krarup, Peter-Martin; Vistisen, Kirsten; Mosgaard, Camilla S; Pedersen, Bente K; Højman, Pernille; Christensen, Jesper F

2018-03-01

Low physical activity level is associated with poor prognosis in patients with colorectal cancer (CRC). To increase physical activity, technology-based platforms are emerging and provide intriguing opportunities to prescribe and monitor active lifestyle interventions. The "Interval Walking in Colorectal Cancer"(I-WALK-CRC) study explores the feasibility and efficacy a home-based interval-walking intervention delivered by a smart-phone application in order to improve cardio-metabolic health profile among CRC survivors. The aim of the present report is to describe the design, methods and recruitment results of the I-WALK-CRC study.Methods/Results: The I-WALK-CRC study is a randomized controlled trial designed to evaluate the feasibility and efficacy of a home-based interval walking intervention compared to a waiting-list control group for physiological and patient-reported outcomes. Patients who had completed surgery for local stage disease and patients who had completed surgery and any adjuvant chemotherapy for locally advanced stage disease were eligible for inclusion. Between October 1st , 2015, and February 1st , 2017, 136 inquiries were recorded; 83 patients were eligible for enrollment, and 42 patients accepted participation. Age and employment status were associated with participation, as participants were significantly younger (60.5 vs 70.8 years, P < 0.001) and more likely to be working (OR 5.04; 95%CI 1.96-12.98, P < 0.001) than non-participants. In the present study, recruitment of CRC survivors was feasible but we aim to better the recruitment rate in future studies. Further, the study clearly favored younger participants. The I-WALK-CRC study will provide important information regarding feasibility and efficacy of a home-based walking exercise program in CRC survivors.

Learning from instructional explanations: effects of prompts based on the active-constructive-interactive framework.

PubMed

Roelle, Julian; Müller, Claudia; Roelle, Detlev; Berthold, Kirsten

2015-01-01

Although instructional explanations are commonly provided when learners are introduced to new content, they often fail because they are not integrated into effective learning activities. The recently introduced active-constructive-interactive framework posits an effectiveness hierarchy in which interactive learning activities are at the top; these are then followed by constructive and active learning activities, respectively. Against this background, we combined instructional explanations with different types of prompts that were designed to elicit these learning activities and tested the central predictions of the active-constructive-interactive framework. In Experiment 1, N = 83 students were randomly assigned to one of four combinations of instructional explanations and prompts. To test the active < constructive learning hypothesis, the learners received either (1) complete explanations and engaging prompts designed to elicit active activities or (2) explanations that were reduced by inferences and inference prompts designed to engage learners in constructing the withheld information. Furthermore, in order to explore how interactive learning activities can be elicited, we gave the learners who had difficulties in constructing the prompted inferences adapted remedial explanations with either (3) unspecific engaging prompts or (4) revision prompts. In support of the active < constructive learning hypothesis, we found that the learners who received reduced explanations and inference prompts outperformed the learners who received complete explanations and engaging prompts. Moreover, revision prompts were more effective in eliciting interactive learning activities than engaging prompts. In Experiment 2, N = 40 students were randomly assigned to either (1) a reduced explanations and inference prompts or (2) a reduced explanations and inference prompts plus adapted remedial explanations and revision prompts condition. In support of the constructive < interactive learning hypothesis, the learners who received adapted remedial explanations and revision prompts as add-ons to reduced explanations and inference prompts acquired more conceptual knowledge.

Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder.

PubMed

Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja; Gold, Christian

2016-01-01

To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and strategies to facilitate study implementation is available in the music therapy literature. Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety, document concomitant treatment, and report consistency of individuals' trends over time in chosen outcome measures. Children with ASD aged between 4 years, 0 months, and 6 years, 11 months, were randomly assigned to one of three conditions: one (low intensity) vs. three weekly IMT sessions (high intensity) for five months vs. standard care. Feasibility was evaluated by examining recruitment, implementation of study conditions, assessment procedures, blinding, and retention; we also evaluated safety, concomitant treatment, and consistency of changes in standardized scales completed by blinded assessors and parents before and 5 months after randomization. Within this subsample (n = 15), recruitment rates, session attendance in the high-intensity condition, and consistency between outcome measures were lower than expected. Session attendance in the low-intensity and control conditions, treatment fidelity, measurement completion, blinding, retention, and safety met a priori thresholds for feasibility. By discussing strategies to improve recruitment and to minimize potential burden on study participants, referrers, and researchers, this study helps build knowledge about designing and implementing trials successfully. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Learning from Instructional Explanations: Effects of Prompts Based on the Active-Constructive-Interactive Framework

PubMed Central

Roelle, Julian; Müller, Claudia; Roelle, Detlev; Berthold, Kirsten

2015-01-01

Although instructional explanations are commonly provided when learners are introduced to new content, they often fail because they are not integrated into effective learning activities. The recently introduced active-constructive-interactive framework posits an effectiveness hierarchy in which interactive learning activities are at the top; these are then followed by constructive and active learning activities, respectively. Against this background, we combined instructional explanations with different types of prompts that were designed to elicit these learning activities and tested the central predictions of the active-constructive-interactive framework. In Experiment 1, N = 83 students were randomly assigned to one of four combinations of instructional explanations and prompts. To test the active < constructive learning hypothesis, the learners received either (1) complete explanations and engaging prompts designed to elicit active activities or (2) explanations that were reduced by inferences and inference prompts designed to engage learners in constructing the withheld information. Furthermore, in order to explore how interactive learning activities can be elicited, we gave the learners who had difficulties in constructing the prompted inferences adapted remedial explanations with either (3) unspecific engaging prompts or (4) revision prompts. In support of the active < constructive learning hypothesis, we found that the learners who received reduced explanations and inference prompts outperformed the learners who received complete explanations and engaging prompts. Moreover, revision prompts were more effective in eliciting interactive learning activities than engaging prompts. In Experiment 2, N = 40 students were randomly assigned to either (1) a reduced explanations and inference prompts or (2) a reduced explanations and inference prompts plus adapted remedial explanations and revision prompts condition. In support of the constructive < interactive learning hypothesis, the learners who received adapted remedial explanations and revision prompts as add-ons to reduced explanations and inference prompts acquired more conceptual knowledge. PMID:25853629

Permission Form Synopses to Improve Parents' Understanding of Research: A Randomized Trial

PubMed Central

D'Angio, Carl T.; Wang, Hongyue; Hunn, Julianne E.; Pryhuber, Gloria S.; Chess, Patricia R.; Lakshminrusimha, Satyan

2017-01-01

Objective We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control). Study Design This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured. Result Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8 ± 5.7 v. 16.3 ± 3.5), subjective understanding (median 6.0 v. 6.5), or overall satisfaction with consent (median 7.0 v. 6.5) between control and intervention groups (all p>0.50). Conclusion A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited. PMID:28358380

Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men

PubMed Central

Das, Moupali; Santos, Deirdre; Matheson, Tim; Santos, Glenn-Milo; Chu, Priscilla; Vittinghoff, Eric; Shoptaw, Steve; Colfax, Grant N.

2010-01-01

Objective To determine whether actively using, methamphetamine (meth)-dependent men who have sex with men (MSM) could be enrolled and retained in a pharmacologic intervention trial, and the degree to which participants would adhere to study procedures, including medication adherence. Study design Phase II randomized, double-blind trial of bupropion vs. placebo. Methods Thirty meth-dependent, sexually active MSM were randomized to receive daily bupropion XL 300 mg or placebo for 12 weeks. Participants received weekly substance use counseling, provided weekly urine specimens, and completed monthly audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps (the number of distinct MEMS cap openings divided by the number of expected doses) and self-report. Results Ninety percent completed the trial: 89% of monthly ACASIs were completed, 81% of study visits were attended, and 81% of urine samples were collected. Adherence by MEMS cap was 60% and by self-report was 81% and did not differ significantly by treatment assignment. The median number of positive urine samples was 5.5 out of a possible 11 (50%). Participants in both arms reported similar declines in the median number of sex partners (P = 0.52). No serious adverse events occurred and there were no significant differences in adverse events by treatment assignment (P = 0.11). Conclusions It is feasible to enroll and retain actively using, meth-dependent MSM in a pharmacologic intervention. Bupropion was well tolerated. Study participation and retention rates were high, however, study drug medication adherence was only moderate. Findings support a larger trial with improved adherence support to evaluate the efficacy of bupropion and other pharmacologic interventions for meth dependence in this population. PMID:20397286

Impact on Family and Parental Stress of Prenatal versus Postnatal Repair of Myelomeningocele

PubMed Central

Antiel, Ryan M.; Adzick, N. Scott; Thom, Elizabeth A.; Burrows, Pamela K.; Farmer, Diana L.; Brock, John W.; Howell, Lori J.; Farrell, Jody A.; Houtrow, Amy J.

2016-01-01

BACKGROUND The Management of Myelomeningocele Study (MOMS) was a multicenter, randomized controlled trial that compared prenatal repair with standard postnatal repair for fetal myelomeningocele. OBJECTIVE We sought to describe the long-term impact on the families of the women who participated and to evaluate how the timing of repair influenced the impact on families and parental stress. STUDY DESIGN Randomized women completed the 24-item Impact on Family Scale (IFS) and the 36-item Parenting Stress Index Short Form (PSI-SF) at 12 and 30 months after delivery. A revised 15-item score of the IFS (RIFS) describing overall impact was also computed. Higher scores reflect more negative impacts or greater stress. In addition, we examined Family Support Scale (FSS) and Family Resource Scale (FRS) scores along with various neonatal outcomes. Repeated measures analysis was conducted for each scale and subscale. RESULTS Of 183 women randomized, 171 women completed the IFS and 172 completed the PSI at both 12 and 30 months. The prenatal surgery group had significantly lower RIFS scores as well as familial-social impact subscale scores compared to the postnatal surgery group (p=0.02 and 0.004, respectively). There was no difference in total parental stress between the two groups (p=0.89) or in any of the PSI-SF subscales. In addition, walking independently at 30 months and family resources at 12 months are associated with both family impact and parental stress. CONCLUSION The overall negative family impact of caring for a child with spina bifida, up to 30 months of age, was significantly lower in the prenatal surgery group compared to the postnatal surgery group. Ambulation status and family resources were predictive of impact on family and parental stress. PMID:27263997

Randomizing Roaches: Exploring the "Bugs" of Randomization in Experimental Design

ERIC Educational Resources Information Center

Wagler, Amy; Wagler, Ron

2014-01-01

Understanding the roles of random selection and random assignment in experimental design is a central learning objective in most introductory statistics courses. This article describes an activity, appropriate for a high school or introductory statistics course, designed to teach the concepts, values and pitfalls of random selection and assignment…

The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial

PubMed Central

2014-01-01

Background Individuals with a personal or family history of cancer, can opt for genetic counseling and DNA-testing. Approximately 25% of these individuals experience clinically relevant levels of psychosocial distress, depression and/or anxiety after counseling. These problems are frequently left undetected by genetic counselors. The aim of this study is to evaluate the efficacy of a cancer genetics-specific screening questionnaire for psychosocial problems, the ‘Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire’ together with the Distress Thermometer, in: (1) facilitating personalized counselor-counselee communication; (2) increasing counselors’ awareness of their counselees’ psychosocial problems; and (3) facilitating the management of psychosocial problems during and after genetic counseling. Methods This multicenter, randomized controlled trial will include 264 individuals undergoing cancer genetic counseling in two family cancer clinics in the Netherlands. Participants will be randomized to either: (1) an intervention group that completes the PAHC questionnaire, the results of which are made available to the genetic counselor prior to the counseling session; or (2) a control group that completes the PAHC questionnaire, but without feedback being given to the genetic counselor. The genetic counseling sessions will be audiotaped for content analysis. Additionally, study participants will be asked to complete questionnaires at baseline, three weeks after the initial counseling session, and four months after a telephone follow-up counseling session. The genetic counselors will be asked to complete questionnaires at the start of and at completion of the study, as well as a checklist directly after each counseling session. The questionnaires/checklists of the study include items on communication during genetic counseling, counselor awareness of their clients’ psychosocial problems, the (perceived) need for professional psychosocial support, cancer worries, general distress, specific psychosocial problems, satisfaction with care received, and experience using the PAHC questionnaire. Discussion This study will provide empirical evidence regarding the efficacy of a relatively brief psychosocial screening questionnaire in terms of facilitating personalized communication, increasing counselors’ awareness, and optimizing management of psychosocial problems in the cancer genetic counseling setting. Trial registration This study is registered at the Netherlands Trial Register (NTR3205) and ClinicalTrials.gov (NCT01562431). PMID:24428912

The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial.

PubMed

Eijzenga, Willem; Aaronson, Neil K; Kluijt, Irma; Sidharta, Grace N; Hahn, Daniela Ee; Ausems, Margreet Gem; Bleiker, Eveline Ma

2014-01-15

Individuals with a personal or family history of cancer, can opt for genetic counseling and DNA-testing. Approximately 25% of these individuals experience clinically relevant levels of psychosocial distress, depression and/or anxiety after counseling. These problems are frequently left undetected by genetic counselors. The aim of this study is to evaluate the efficacy of a cancer genetics-specific screening questionnaire for psychosocial problems, the 'Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire' together with the Distress Thermometer, in: (1) facilitating personalized counselor-counselee communication; (2) increasing counselors' awareness of their counselees' psychosocial problems; and (3) facilitating the management of psychosocial problems during and after genetic counseling. This multicenter, randomized controlled trial will include 264 individuals undergoing cancer genetic counseling in two family cancer clinics in the Netherlands. Participants will be randomized to either: (1) an intervention group that completes the PAHC questionnaire, the results of which are made available to the genetic counselor prior to the counseling session; or (2) a control group that completes the PAHC questionnaire, but without feedback being given to the genetic counselor. The genetic counseling sessions will be audiotaped for content analysis. Additionally, study participants will be asked to complete questionnaires at baseline, three weeks after the initial counseling session, and four months after a telephone follow-up counseling session. The genetic counselors will be asked to complete questionnaires at the start of and at completion of the study, as well as a checklist directly after each counseling session. The questionnaires/checklists of the study include items on communication during genetic counseling, counselor awareness of their clients' psychosocial problems, the (perceived) need for professional psychosocial support, cancer worries, general distress, specific psychosocial problems, satisfaction with care received, and experience using the PAHC questionnaire. This study will provide empirical evidence regarding the efficacy of a relatively brief psychosocial screening questionnaire in terms of facilitating personalized communication, increasing counselors' awareness, and optimizing management of psychosocial problems in the cancer genetic counseling setting. This study is registered at the Netherlands Trial Register (NTR3205) and ClinicalTrials.gov (NCT01562431).

Prospecting of popcorn hybrids for resistance to fall armyworm.

PubMed

Crubelati-Mulati, N C S; Scapim, C A; Albuquerque, F A; Amaral Junior, A T; Vivas, M; Rodovalho, M A

2014-08-26

The fall armyworm, Spodoptera frugiperda, is the pest that causes the greatest economic losses for both common corn and popcorn crops, and the use of resistant plant genotypes is an important tool for integrated pest management. The goal of the present study was to evaluate the damage caused by S. frugiperda on single-cross popcorn hybrids under field conditions with natural infestation as well as to study the effect of 11 popcorn hybrids on the S. frugiperda life cycle under laboratory conditions. A completely randomized block design with 4 replicates was used for the field experiment, and a completely randomized design with 10 replicates was used for the laboratory experiment. In the field experiment, the damage caused by fall armyworm, grain yield, and popping expansion were quantified, and a diallel analysis was performed to select the best hybrids. For the laboratory experiment, caterpillars were obtained from laboratory cultures kept on an artificial diet and were fed with leaves from the 11 hybrids. Hybrids P7.0 x P9.4, P7.1 x P9.6, P7.2.0 x P9.3, P7.4.0 x P9.1 and P7.4.1 x P9.4 exhibited negative specific combining ability for injury by fall armyworm and positive specific combining ability for yield and popping expansion. In the laboratory experiment, the hybrids influenced the mean larval stage duration, mean larval mass, final larval mass, pupal stage duration, mean pupal mass, and adult longevity.

A model of tailoring effects: A randomized controlled trial examining the mechanisms of tailoring in a web-based STD screening intervention.

PubMed

Lustria, Mia Liza A; Cortese, Juliann; Gerend, Mary A; Schmitt, Karla; Kung, Ying Mai; McLaughlin, Casey

2016-11-01

This study explores the mechanisms of tailoring within the context of RU@Risk a brief Web-based intervention designed to promote sexually transmitted disease (STD) testing among young adults. This is one of a few studies to empirically examine theorized message processing mechanisms of tailoring and persuasion outcomes in a single model. Sexually active college students (N = 1065) completed a pretest, were randomly assigned to explore a tailored or nontailored website, completed a posttest, and were offered the opportunity to order a free at-home STD test kit. As intervention effects were hypothesized to work via increases in perceived risk, change in perceived risk from pretest to posttest by condition was examined. Hypothesized mechanisms of tailoring (perceived personal relevance, attention, and elaboration) were examined using structural equation modeling (SEM). All analyses controlled for demographic variables and sexual history. As predicted, perceived risk of STDs increased from pretest to posttest, but only in the tailored condition. Results revealed that exposure to the tailored (vs. nontailored) website increased perceived personal relevance, attention to, and elaboration of the message. These effects in turn were associated with greater perceived risk of STDs and intentions to get tested. Additionally, participants in the tailored condition were more likely to order a test kit. Findings provide insight into the mechanisms of tailoring with important implications for optimizing message design. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

A randomized controlled trial assessing the effectiveness of strategies delivering low vision rehabilitation: design and baseline characteristics of study participants.

PubMed

Christy, Beula; Keeffe, Jill E; Nirmalan, Praveen K; Rao, Gullapalli N

2010-08-01

To design a randomized controlled trial (RCT) to compare the effectiveness of four different strategies to deliver low vision rehabilitation services. The four arms of the RCT comprised-center based rehabilitation, home based rehabilitation, a mix of center based and home based rehabilitation, and center based rehabilitation with home based non interventional supplementary visits by rehabilitation workers. Outcomes were assessed 9 months after baseline and included measuring changes in adaptation to age-related vision loss, quality of life, impact of vision impairment and effectiveness of low vision rehabilitation training. The socio-demographic and vision characteristics of the sample in each of the 4 arms were compared to ensure that outcomes are not associated with differences between the groups. Four hundred and thirty six individuals were enrolled in the study; 393 individuals completed the study. One-fifth of participants were children aged 8 to 16 years. At baseline, socio-demographic and clinical characteristics were similar between individuals in the four arms of the trial. Socio-demographic and clinical characteristics did not differ significantly, except for age, between the 393 individuals who completed the trial and the 43 individuals who dropped out of the study. Twenty six (60.46%) of the forty three drop outs were from the center based arm of the trial. Information from this trial has the potential to shape policy and practice pertaining to low vision rehabilitation services.

Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial.

PubMed

Trent, Maria; Chung, Shang-En; Gaydos, Charlotte; Frick, Kevin D; Anders, Jennifer; Huettner, Steven; Rothman, Richard; Butz, Arlene

2016-08-01

Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused on strategies to improve outpatient adherence or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community-health nursing (TECH-N) intervention among urban AYA with PID. AYA women aged 13-25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing performed at the 30-and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. In the first 48 months, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been within the 5-day window and over 90% of patients in both arms have been retained over the 3-month follow-up period. Biological data suggests a shift in the biological milieu with the predominance of Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis infections. Preliminary data from the TECH-N study demonstrated that urban, low-income, minority AYA with PID can effectively be recruited and retained to participate in sexual and reproductive health RCTs with sufficient investment in the design and infrastructure of the study. Community-based sexual health interventions appear to be both feasible and acceptable in this population.

Using a UK Virtual Supermarket to Examine Purchasing Behavior Across Different Income Groups in the United Kingdom: Development and Feasibility Study

PubMed Central

Waterlander, Wilma Elzeline; Rayner, Mike; Scarborough, Peter

2017-01-01

Background The majority of food in the United Kingdom is purchased in supermarkets, and therefore, supermarket interventions provide an opportunity to improve diets. Randomized controlled trials are costly, time-consuming, and difficult to conduct in real stores. Alternative approaches of assessing the impact of supermarket interventions on food purchases are needed, especially with respect to assessing differential impacts on population subgroups. Objective The aim of this study was to assess the feasibility of using the United Kingdom Virtual Supermarket (UKVS), a three-dimensional (3D) computer simulation of a supermarket, to measure food purchasing behavior across income groups. Methods Participants (primary household shoppers in the United Kingdom with computer access) were asked to conduct two shopping tasks using the UKVS and complete questionnaires on demographics, food purchasing habits, and feedback on the UKVS software. Data on recruitment method and rate, completion of study procedure, purchases, and feedback on usability were collected to inform future trial protocols. Results A total of 98 participants were recruited, and 46 (47%) fully completed the study procedure. Low-income participants were less likely to complete the study (P=.02). Most participants found the UKVS easy to use (38/46, 83%) and reported that UKVS purchases resembled their usual purchases (41/46, 89%). Conclusions The UKVS is likely to be a useful tool to examine the effects of nutrition interventions using randomized controlled designs. Feedback was positive from participants who completed the study and did not differ by income group. However, retention was low and needs to be addressed in future studies. This study provides purchasing data to establish sample size requirements for full trials using the UKVS. PMID:28993301

Direct-to-Consumer Prescription Drug Advertising and the Public

PubMed Central

Bell, Robert A; Kravitz, Richard L; Wilkes, Michael S

1999-01-01

OBJECTIVE Drug manufacturers are intensely promoting their products directly to consumers, but the impact has not been widely studied. Consumers' awareness and understanding of, attitudes toward, and susceptibility to direct-to-consumer (DTC) drug advertising were examined. DESIGN Random-digit dialing telephone survey with a random household member selection procedure (completion and response rates, 58% and 69%, respectively). SETTING Respondents were interviewed while they were at their residences. PARTICIPANTS Complete data were obtained from 329 adults in Sacramento County, California. MEASUREMENTS AND MAIN RESULTS Outcome measures included awareness of advertisements for 10 selected drugs, misconceptions about DTC advertising, attitudes toward DTC ads, and behavioral responses to such promotions. The influence of demographic characteristics, health status, attitudes, beliefs, and media exposure on awareness and behaviors was examined. On average, respondents were aware of advertisements for 3.7 of the 10 drugs; awareness varied from 8% for Buspar (buspirone) to 72% for Claritin (loratadine). Awareness was associated with prescription drug use, media exposure, positive attitudes toward DTC advertising, poorer health, and insurance status. Substantial misconceptions were revealed; e.g., 43% thought that only “completely safe” drugs could be advertised. Direct-to-consumer advertisements had led one third of respondents to ask their physicians for drug information and one fifth to request a prescription. CONCLUSIONS Direct-to-consumer advertisements are reaching the public, but selectively so, and affecting their behaviors. Implications for public policy are examined. PMID:10571712

Environmental qualification testing of payload G-534, the Pool Boiling Experiment

NASA Technical Reports Server (NTRS)

Sexton, J. Andrew

1992-01-01

Payload G-534, the prototype Pool Boiling Experiment (PBE), is scheduled to fly on the STS-47 mission in September 1992. This paper describes the purpose of the experiment and the environmental qualification testing program that was used to prove the integrity of the hardware. Component and box level vibration and thermal cycling tests were performed to give an early level of confidence in the hardware designs. At the system level, vibration, thermal extreme soaks, and thermal vacuum cycling tests were performed to qualify the complete design for the expected shuttle environment. The system level vibration testing included three axis sine sweeps and random inputs. The system level hot and cold soak tests demonstrated the hardware's capability to operate over a wide range of temperatures and gave wider latitude in determining which shuttle thermal attitudes were compatible with the experiment. The system level thermal vacuum cycling tests demonstrated the hardware's capability to operate in a convection free environment. A unique environmental chamber was designed and fabricated by the PBE team and allowed most of the environmental testing to be performed within the hardware build laboratory. The completion of the test program gave the project team high confidence in the hardware's ability to function as designed during flight.

Randomized controlled trial to evaluate the effects of combined progressive exercise on metabolic syndrome in breast cancer survivors: rationale, design, and methods

PubMed Central

2014-01-01

Background Metabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments. Methods/Design This study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation. Discussion This is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship, and that are ultimately aimed at improving prognosis. Trial registration NCT01140282; Registration: June 10, 2010 PMID:24708832

Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD). Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient’s treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. Methods/design Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1) cognitive behavior therapy (CBT, 16 sessions); (2) duloxetine (30–60 mg/d); or (3) escitalopram (10–20 mg/d). Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI), immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH) testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products) occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12-week course of treatment, during which they receive a combination of CBT and antidepressant medication. Predictors of the primary outcome, remission, will be identified for overall and treatment-specific effects, and a statistical model incorporating multiple predictors will be developed to predict outcomes. Discussion The PReDICT study’s evaluation of biological, psychological, and clinical factors that may differentially impact treatment outcomes represents a sizeable step toward developing personalized treatments for MDD. Identified predictors should help guide the selection of initial treatments, and identify those patients most vulnerable to recurrence, who thus warrant maintenance or combination treatments to achieve and maintain wellness. Trial registration Clinicaltrials.gov Identifier: NCT00360399. Registered 02 AUG 2006. First patient randomized 09 FEB 2007. PMID:22776534

Comparative Efficacy and Durability of Continuation Phase Cognitive Therapy for Preventing Recurrent Depression: Design of a Double-Blinded, Fluoxetine- and Pill-Placebo–Controlled, Randomized Trial with 2-Year Follow-up

PubMed Central

Thase, Michael E.

2010-01-01

Background Major depressive disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences. Purpose This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower versus higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24-months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX). Methods Outpatients, aged 18 to 70 years, with recurrent MDD received 12–14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression ≤ 12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months. Results The trial began in 2000. Enrollment is complete (N=523). The follow-up continues. Conclusions The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide. PMID:20451668

HIV salvage therapy does not require nucleoside reverse transcriptase inhibitors: a randomized trial

PubMed Central

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-01-01

Background Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral (ARV) regimens in treatment-experienced patients in the absence of data from randomized trials. Objective To compare treatment success between participants who omit versus Add NRTIs to an optimized ARV regimen of three or more agents. Design Multisite, randomized, controlled trial. Setting Outpatient HIV clinics. Participants HIV-infected patients with three-class ARV experience and/or viral resistance. Intervention Open-label optimized regimens (not including NRTIs) were selected based upon treatment history and susceptibility testing. Participants were randomized to Omit or Add NRTIs. Measurements The primary efficacy outcome was regimen failure through week 48, using a non-inferiority margin of 15%. The primary safety outcome was time to initial episode of severe sign/symptom or laboratory abnormality prior to discontinuation of NRTI assignment. Results 360 participants were randomized and 93% completed a week 48 visit. The cumulative probability of regimen failure was 29.8% in the Omit NRTI arm versus 25.9% in the Add NRTI arm (difference= 3.2%: 95% CI, −6.1 to 12.5). There were no significant differences in the primary safety endpoints or the proportion of participants with HIV RNA <50 copies/mL between arms. No deaths occurred in the Omit NRTIs arm, compared with 7 deaths in the Add NRTIs arm. Limitations Non-blinded study design and may not be applicable to resource poor settings. Conclusion HIV-infected treatment-experienced patients starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. PMID:26595748

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial

PubMed Central

2013-01-01

Background There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users’ readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Methods Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. Results The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants’ therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Conclusion Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. Trial registration ClinicalTrials.Gov.UK Identifier - NCT01132976 PMID:23414174

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial.

PubMed

McMurran, Mary; Cox, W Miles; Whitham, Diane; Hedges, Lucy

2013-02-17

There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users' readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants' therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. ClinicalTrials.Gov.UK Identifier - NCT01132976.

Glutamine supplementation in cystic fibrosis: A randomized placebo-controlled trial.

PubMed

Forrester, Doug L; Knox, Alan J; Smyth, Alan R; Barr, Helen L; Simms, Rebecca; Pacey, Sarah J; Pavord, Ian D; Honeybourne, David; Dewar, Jane; Clayton, Andy; Fogarty, Andrew W

2016-03-01

Pulmonary infection and malnutrition in cystic fibrosis are associated with decreased survival. Glutamine has a possible anti-microbial effect, with a specific impact against Pseudomonas aeruginosa. We aimed to test the hypothesis that oral glutamine supplementation (21 g/day) for 8 weeks in adults with cystic fibrosis would decrease pulmonary inflammation and improve clinical status. The study design was a randomized double-blind placebo-controlled study design with an iso-nitrogenous placebo. The primary analysis was intention to treat, and the primary outcome was change in induced sputum neutrophils. Thirty-nine individuals were recruited and thirty-six completed the study. Glutamine supplementation had no impact on any of the outcome measures in the intention-to-treat analysis. In the per protocol analysis, glutamine supplementation was associated with an increase in induced sputum neutrophils (P = 0.046), total cells (P = 0.03), and in Pseudomonas isolation agar colony forming units (P = 0.04) compared to placebo. There was no effect of glutamine supplementation on markers of pulmonary inflammation in the intention-to-treat analysis. © 2015 Wiley Periodicals, Inc.

Finding the Optimal Nets for Self-Folding Kirigami

NASA Astrophysics Data System (ADS)

Araújo, N. A. M.; da Costa, R. A.; Dorogovtsev, S. N.; Mendes, J. F. F.

2018-05-01

Three-dimensional shells can be synthesized from the spontaneous self-folding of two-dimensional templates of interconnected panels, called nets. However, some nets are more likely to self-fold into the desired shell under random movements. The optimal nets are the ones that maximize the number of vertex connections, i.e., vertices that have only two of its faces cut away from each other in the net. Previous methods for finding such nets are based on random search, and thus, they do not guarantee the optimal solution. Here, we propose a deterministic procedure. We map the connectivity of the shell into a shell graph, where the nodes and links of the graph represent the vertices and edges of the shell, respectively. Identifying the nets that maximize the number of vertex connections corresponds to finding the set of maximum leaf spanning trees of the shell graph. This method allows us not only to design the self-assembly of much larger shell structures but also to apply additional design criteria, as a complete catalog of the maximum leaf spanning trees is obtained.

A Randomized Trial Comparing Classical Participatory Design to VandAID, an Interactive CrowdSourcing Platform to Facilitate User-centered Design.

PubMed

Dufendach, Kevin R; Koch, Sabine; Unertl, Kim M; Lehmann, Christoph U

2017-10-26

Early involvement of stakeholders in the design of medical software is particularly important due to the need to incorporate complex knowledge and actions associated with clinical work. Standard user-centered design methods include focus groups and participatory design sessions with individual stakeholders, which generally limit user involvement to a small number of individuals due to the significant time investments from designers and end users. The goal of this project was to reduce the effort for end users to participate in co-design of a software user interface by developing an interactive web-based crowdsourcing platform. In a randomized trial, we compared a new web-based crowdsourcing platform to standard participatory design sessions. We developed an interactive, modular platform that allows responsive remote customization and design feedback on a visual user interface based on user preferences. The responsive canvas is a dynamic HTML template that responds in real time to user preference selections. Upon completion, the design team can view the user's interface creations through an administrator portal and download the structured selections through a REDCap interface. We have created a software platform that allows users to customize a user interface and see the results of that customization in real time, receiving immediate feedback on the impact of their design choices. Neonatal clinicians used the new platform to successfully design and customize a neonatal handoff tool. They received no specific instruction and yet were able to use the software easily and reported high usability. VandAID, a new web-based crowdsourcing platform, can involve multiple users in user-centered design simultaneously and provides means of obtaining design feedback remotely. The software can provide design feedback at any stage in the design process, but it will be of greatest utility for specifying user requirements and evaluating iterative designs with multiple options.

Percolation of the site random-cluster model by Monte Carlo method

NASA Astrophysics Data System (ADS)

Wang, Songsong; Zhang, Wanzhou; Ding, Chengxiang

2015-08-01

We propose a site random-cluster model by introducing an additional cluster weight in the partition function of the traditional site percolation. To simulate the model on a square lattice, we combine the color-assignation and the Swendsen-Wang methods to design a highly efficient cluster algorithm with a small critical slowing-down phenomenon. To verify whether or not it is consistent with the bond random-cluster model, we measure several quantities, such as the wrapping probability Re, the percolating cluster density P∞, and the magnetic susceptibility per site χp, as well as two exponents, such as the thermal exponent yt and the fractal dimension yh of the percolating cluster. We find that for different exponents of cluster weight q =1.5 , 2, 2.5 , 3, 3.5 , and 4, the numerical estimation of the exponents yt and yh are consistent with the theoretical values. The universalities of the site random-cluster model and the bond random-cluster model are completely identical. For larger values of q , we find obvious signatures of the first-order percolation transition by the histograms and the hysteresis loops of percolating cluster density and the energy per site. Our results are helpful for the understanding of the percolation of traditional statistical models.

Development and pilot of an advance care planning website for women with ovarian cancer: a randomized controlled trial.

PubMed

Vogel, Rachel Isaksson; Petzel, Sue V; Cragg, Julie; McClellan, Molly; Chan, Daniel; Dickson, Elizabeth; Jacko, Julie A; Sainfort, François; Geller, Melissa A

2013-11-01

Few available tools facilitate cancer patients and physicians' discussions of quality of life and end-of-life. Our objective was to develop a web-based tool to promote advance care planning for women with ovarian cancer. Women with ovarian cancer, their families, clinicians and researchers met to identify ways to improve cancer care. A prototype website was created to address advance care planning, focusing on advance healthcare directives (AHD) and palliative care consultation. Patients were recruited from a gynecologic oncology clinic for a pilot randomized controlled trial. Primary outcomes included completion of an AHD and palliative care consultation. At study completion, 53 women with ovarian cancer were enrolled and 35 completed the study. The mean age at enrollment was 57.9 ± 9.5 years; most were newly diagnosed or at first recurrence. There were no statistical differences in completion of AHD (p=0.220) or palliative care consultation (p=0.440) between intervention and control groups. However, women in the intervention group showed evidence of moving toward decision making regarding AHD and palliative care and lower decisional conflict. Women assigned to the intervention, compared to control website, were highly satisfied with the amount (p=0.054) and quality (p=0.119) of information and when they accessed the website, used it longer (p=0.049). Overall website use was lower than expected, resulting from several patient-related and design barriers. A website providing information and decisional support for women with ovarian cancer is feasible. Increasing frequency of website use requires future research. © 2013.

Development and pilot of an advance care planning website for women with ovarian cancer: A randomized controlled trial

PubMed Central

Vogel, Rachel Isaksson; Petzel, Sue V.; Cragg, Julie; McClellan, Molly; Chan, Daniel; Dickson, Elizabeth; Jacko, Julie A.; Sainfort, François; Geller, Melissa A.

2015-01-01

Objective Few available tools facilitate cancer patients and physicians' discussions of quality of life and end-of-life. Our objective was to develop a web-based tool to promote advance care planning for women with ovarian cancer. Methods Women with ovarian cancer, their families, clinicians and researchers met to identify ways to improve cancer care. A prototype website was created to address advance care planning, focusing on advance healthcare directives (AHD) and palliative care consultation. Patients were recruited from a gynecologic oncology clinic for a pilot randomized controlled trial. Primary outcomes included completion of an AHD and palliative care consultation. Results At study completion, 53 women with ovarian cancer were enrolled and 35 completed the study. The mean age at enrollment was 57.9 ± 9.5 years; most were newly diagnosed or at first recurrence. There were no statistical differences in completion of AHD (p = 0.220) or palliative care consultation (p = 0.440) between intervention and control groups. However, women in the intervention group showed evidence of moving toward decision making regarding AHD and palliative care and lower decisional conflict. Women assigned to the intervention, compared to control website, were highly satisfied with the amount (p = 0.054) and quality (p = 0.119) of information and when they accessed the website, used it longer (p = 0.049). Overall website use was lower than expected, resulting from several patient-related and design barriers. Conclusions A website providing information and decisional support for women with ovarian cancer is feasible. Increasing frequency of website use requires future research. PMID:23988413

New Estimates of Design Parameters for Clustered Randomization Studies: Findings from North Carolina and Florida. Working Paper 43

ERIC Educational Resources Information Center

Xu, Zeyu; Nichols, Austin

2010-01-01

The gold standard in making causal inference on program effects is a randomized trial. Most randomization designs in education randomize classrooms or schools rather than individual students. Such "clustered randomization" designs have one principal drawback: They tend to have limited statistical power or precision. This study aims to…

47 CFR 1.1602 - Designation for random selection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Designation for random selection. 1.1602 Section 1.1602 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1602 Designation for random selection...

47 CFR 1.1602 - Designation for random selection.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Designation for random selection. 1.1602 Section 1.1602 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1602 Designation for random selection...

The design and implementation of a randomized controlled trial of a risk reduction and human immunodeficiency virus prevention videogame intervention in minority adolescents: PlayForward: Elm City Stories.

PubMed

Fiellin, Lynn E; Kyriakides, Tassos C; Hieftje, Kimberly D; Pendergrass, Tyra M; Duncan, Lindsay R; Dziura, James D; Sawyer, Benjamin G; Fiellin, David A

2016-08-01

To address the need for risk behavior reduction and human immunodeficiency virus prevention interventions that capture adolescents "where they live," we created a tablet-based videogame to teach skills and knowledge and influence psychosocial antecedents for decreasing risk and preventing human immunodeficiency virus infection in minority youth in schools, after-school programs, and summer camps. We developed PlayForward: Elm City Stories over a 2-year period, working with researchers, commercial game designers, and staff and teens from community programs. The videogame PlayForward provides an interactive world where players, using an avatar, "travel" through time, facing challenges such as peer pressure to drink alcohol or engage in risky sexual behaviors. Players experience how their choices affect their future and then are able to go back in time and change their choices, creating different outcomes. A randomized controlled trial was designed to evaluate the efficacy of PlayForward. Participants were randomly assigned to play PlayForward or a set of attention/time control games on a tablet at their community-based program. Assessment data were collected during face-to-face study visits and entered into a web-based platform and unique real-time "in-game" PlayForward data were collected as players engaged in the game. The innovative methods of this randomized controlled trial are described. We highlight the logistical issues of conducting a large-scale trial using mobile technology such as the iPad(®), and collecting, transferring, and storing large amounts of in-game data. We outline the methods used to analyze the in-game data alone and in conjunction with standardized assessment data to establish correlations between behaviors during gameplay and those reported in real life. We also describe the use of the in-game data as a measure of fidelity to the intervention. In total, 333 boys and girls, aged 11-14 years, were randomized over a 14-month period: 166 were assigned to play PlayForward and 167 to play the control games. To date (as of 1 March 2016), 18 have withdrawn from the study; the following have completed the protocol-defined assessments: 6 weeks: 271 (83%), 3 months: 269 (84%), 6 months: 254 (79%), 12 months: 259 (82%), and 24 months: is ongoing with 152 having completed out of the 199 participants (76%) who were eligible to date (assessment windows were still open). Videogames can be developed to address complex behaviors and can be subject to empiric testing using community-based randomized controlled trials. Although mobile technologies pose challenges in their use as interventions and in the collection and storage of data they produce, they provide unique opportunities as new sources of potentially valid data and novel methods to measure the fidelity of digitally delivered behavioral interventions. © The Author(s) 2016.

The design and implementation of a randomized controlled trial of a risk reduction and human immunodeficiency virus prevention videogame intervention in minority adolescents: PlayForward: Elm City Stories

PubMed Central

Fiellin, Lynn E; Kyriakides, Tassos C; Hieftje, Kimberly D; Pendergrass, Tyra M; Duncan, Lindsay R; Dziura, James D; Sawyer, Benjamin G; Fiellin, David A

2016-01-01

Background To address the need for risk behavior reduction and HIV prevention interventions that capture adolescents “where they live,” we created a tablet-based videogame to teach skills and knowledge and influence psychosocial antecedents for decreasing risk and preventing HIV infection in minority youth in schools, after-school programs, and summer camps. Methods We developed PlayForward: Elm City Stories over a 2-year period, working with researchers, commercial game designers, and staff and teens from community programs. The videogame PlayForward provides an interactive world where players, using an avatar, “travel” through time, facing challenges such as peer pressure to drink alcohol or engage in risky sexual behaviors. Players experience how their choices affect their future and then are able to go back in time and change their choices, creating different outcomes. A randomized controlled trial was designed to evaluate the efficacy of PlayForward. Participants were randomly assigned to play PlayForward or a set of attention/time control games on a tablet at their community-based program. Assessment data were collected during face-to-face study visits and entered into a web-based platform and unique real-time “in-game” PlayForward data were collected as players engaged in the game. The innovative methods of this randomized controlled trial are described. We highlight the logistical issues of conducting a large-scale trial using mobile technology such as the iPad®, and collecting, transferring, and storing large amounts of in-game data. We outline the methods used to analyze the in-game data alone and in conjunction with standardized assessment data to establish correlations between behaviors during gameplay and those reported in real life. We also describe the use of the in-game data as a measure of fidelity to the intervention. Results In total, 333 boys and girls, aged 11–14 years, were randomized over a 14-month period: 166 were assigned to play PlayForward and 167 to play the control games. To date (as of 1 March 2016), 18 have withdrawn from the study; the following have completed the protocol-defined assessments: 6 weeks: 271 (83%); 3 months: 269 (84%); 6 months: 254 (79%); 12 months: 259 (82%); and 24 months: is ongoing with 152 having completed out of the 199 participants (76%) who were eligible to date (assessment windows were still open). Conclusion Videogames can be developed to address complex behaviors and can be subject to empiric testing using community-based randomized controlled trials. Although mobile technologies pose challenges in their use as interventions and in the collection and storage of data they produce, they provide unique opportunities as new sources of potentially valid data and novel methods to measure the fidelity of digitally delivered behavioral interventions. PMID:27013483

A guide to missing data for the pediatric nephrologist.

PubMed

Larkins, Nicholas G; Craig, Jonathan C; Teixeira-Pinto, Armando

2018-03-13

Missing data is an important and common source of bias in clinical research. Readers should be alert to and consider the impact of missing data when reading studies. Beyond preventing missing data in the first place, through good study design and conduct, there are different strategies available to handle data containing missing observations. Complete case analysis is often biased unless data are missing completely at random. Better methods of handling missing data include multiple imputation and models using likelihood-based estimation. With advancing computing power and modern statistical software, these methods are within the reach of clinician-researchers under guidance of a biostatistician. As clinicians reading papers, we need to continue to update our understanding of statistical methods, so that we understand the limitations of these techniques and can critically interpret literature.

Feasibility study design and methods for a home-based, square-stepping exercise program among older adults with multiple sclerosis: The SSE-MS project.

PubMed

Sebastião, Emerson; McAuley, Edward; Shigematsu, Ryosuke; Motl, Robert W

2017-09-01

We propose a randomized controlled trial (RCT) examining the feasibility of square-stepping exercise (SSE) delivered as a home-based program for older adults with multiple sclerosis (MS). We will assess feasibility in the four domains of process, resources, management and scientific outcomes. The trial will recruit older adults (aged 60 years and older) with mild-to-moderate MS-related disability who will be randomized into intervention or attention control conditions. Participants will complete assessments before and after completion of the conditions delivered over a 12-week period. Participants in the intervention group will have biweekly meetings with an exercise trainer in the Exercise Neuroscience Research Laboratory and receive verbal and visual instruction on step patterns for the SSE program. Participants will receive a mat for home-based practice of the step patterns, an instruction manual, and a logbook and pedometer for monitoring compliance. Compliance will be further monitored through weekly scheduled Skype calls. This feasibility study will inform future phase II and III RCTs that determine the actual efficacy and effectiveness of a home-based exercise program for older adults with MS.

Determining knowledge and behaviour change after nutrition screening among older adults.

PubMed

Southgate, Katherine M; Keller, Heather H; Reimer, Holly D

2010-01-01

Two education interventions involving personalized messages after nutrition screening in older adults were compared to determine changes in nutrition knowledge and risk behaviour. Of 150 older adults randomly selected from a local seniors' centre, 61 completed baseline screening and a demographic and nutrition knowledge questionnaire and were randomized to one of two groups. Group A received personalized letters plus an educational booklet, and Group B received personalized letters only. All materials were sent through the mail. Forty-four participants completed post-test questionnaires to determine change in knowledge and risk behaviour. Both groups had reduced nutrition risk scores and increased knowledge scores at post-test. After the intervention, a significant difference was observed in knowledge change by treatment group. Group A participants experienced greater gains in knowledge, with a mean gain of 5.43 points, than did those in Group B, who had a mean gain of 1.36 points (p=0.018). Screening and education with print materials have the potential to change risk behaviour and nutrition knowledge in older adults. A specially designed booklet on older adults' nutrition risk factors plus a personalized letter provide an effective education strategy for older adults after screening.

A policy for science.

PubMed

Lauer, Michael S

2012-06-12

Policy and science often interact. Typically, we think of policymakers looking to scientists for advice on issues informed by science. We may appreciate less the opposite look: where people outside science inform policies that affect the conduct of science. In clinical medicine, we are forced to make decisions about practices for which there is insufficient, inadequate evidence to know whether they improve clinical outcomes, yet the health care system may not be structured to rapidly generate needed evidence. For example, when the Centers for Medicare and Medicaid Services noted insufficient evidence to support routine use of computed tomography angiography and they called for a national commitment to completion of randomized trials, their call ran into substantial opposition. I use the computed tomography angiography story to illustrate how we might consider a "policy for science" in which stakeholders would band together to identify evidence gaps and to use their influence to promote the efficient design, implementation, and completion of high-quality randomized trials. Such a policy for science could create a culture that incentivizes and invigorates the rapid generation of evidence, ultimately engaging all clinicians, all patients, and indeed all stakeholders into the scientific enterprise. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Teen CHAT: Development and Utilization of a Web-Based Intervention to Improve Physician Communication with Adolescents About Healthy Weight

PubMed Central

Bravender, Terrill; Tulsky, James A.; Farrell, David; Alexander, Stewart C.; Østbye, Truls; Lyna, Pauline; Dolor, Rowena J.; Coffman, Cynthia J.; Bilheimer, Alicia; Lin, Pao-Hwa; Pollak, Kathryn I.

2013-01-01

Objective To describe the theoretical basis, use, and satisfaction with Teen CHAT, an online educational intervention designed to improve physician-adolescent communication about healthy weight. Methods Routine health maintenance encounters between pediatricians and family practitioners and their overweight adolescent patients were audio recorded, and content was coded to summarize adherence with motivational interviewing techniques. An online educational intervention was developed using constructs from social cognitive theory and using personalized audio recordings. Physicians were randomized to the online intervention or not, and completed post-intervention surveys. Results Forty-six physicians were recruited, and 22 physicians were randomized to view the intervention website. The educational intervention took an average of 54 minutes to complete, and most physicians thought it was useful, that they would use newly acquired skills with their patients, and would recommend it to others. Fewer physicians thought it helped them address confidentiality issues with their adolescent patients. Conclusion The Teen CHAT online intervention shows potential for enhancing physician motivational interviewing skills in an acceptable and time-efficient manner. Practice Implications If found to be effective in enhancing motivational interviewing skills and changing adolescent weight-related behaviors, wide dissemination will be feasible and indicated. PMID:24021419

[Formula: see text]-convergence, complete convergence, and weak laws of large numbers for asymptotically negatively associated random vectors with values in [Formula: see text].

PubMed

Ko, Mi-Hwa

2018-01-01

In this paper, based on the Rosenthal-type inequality for asymptotically negatively associated random vectors with values in [Formula: see text], we establish results on [Formula: see text]-convergence and complete convergence of the maximums of partial sums are established. We also obtain weak laws of large numbers for coordinatewise asymptotically negatively associated random vectors with values in [Formula: see text].

Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

PubMed

VanVleet, Thomas; Voss, Michelle; Dabit, Sawsan; Mitko, Alex; DeGutis, Joseph

2018-05-03

Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual's level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and increased risk of falls or motor-vehicle accidents. Several experimental behavioral therapies designed to remediate age-related cognitive decline have been developed, but differ widely in content, method and dose. Preliminary studies demonstrate that Tonic and Phasic Alertness Training (TAPAT) can improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments. The purpose of the current trial (referred to as the Attention training for Learning Enhancement and Resilience Trial or ALERT) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 120 patients with age-related cognitive decline. Patients will be asked to complete 36 training sessions remotely (30 min/day, 5 days a week, over 3 months) of either the experimental TAPAT training program or an active control computer games condition. Patients will be assessed on a battery of cognitive and functional outcomes at four time points, including: a) immediately before training, b) halfway through training, c) within forty-eight hours post completion of total training, and d) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in adults with age-related cognitive decline; employs highly sensitive computer-based assessments of cognition as well as functional abilities, and incorporates a large sample size in an RCT design. ClinicalTrials.gov identifier: NCT02416401.

Decision analysis to complete diagnostic research by closing the gap between test characteristics and cost-effectiveness.

PubMed

Schaafsma, Joanna D; van der Graaf, Yolanda; Rinkel, Gabriel J E; Buskens, Erik

2009-12-01

The lack of a standard methodology in diagnostic research impedes adequate evaluation before implementation of constantly developing diagnostic techniques. We discuss the methodology of diagnostic research and underscore the relevance of decision analysis in the process of evaluation of diagnostic tests. Overview and conceptual discussion. Diagnostic research requires a stepwise approach comprising assessment of test characteristics followed by evaluation of added value, clinical outcome, and cost-effectiveness. These multiple goals are generally incompatible with a randomized design. Decision-analytic models provide an important alternative through integration of the best available evidence. Thus, critical assessment of clinical value and efficient use of resources can be achieved. Decision-analytic models should be considered part of the standard methodology in diagnostic research. They can serve as a valid alternative to diagnostic randomized clinical trials (RCTs).

Evaluation of a Culturally Targeted, Personalized Mail-Home Brochure Directed to Partners of At-Risk Men to Facilitate Prostate Cancer Risk Assessment

DTIC Science & Technology

2010-11-01

described the study design, study measures, st udy records to be kept, and the data safety and monitoring plan for protection of human subjects. On...KnowlegePanel 9 Miller, Suzanne were canvassed for participation in the st udy (see Table 1). Of th ese, 1085 agreed to participate, of whom 341...were d etermined to be eligib le. A tota l of 3 32 of the la tter completed the baseline survey, after which they were randomized in equal numbers to

A Study to Design a Functional Patient Health Education Program for Implementation at the United States Army Medical Department Activity, Fort Benning, Georgia

DTIC Science & Technology

1980-08-01

Inventory of Innovations Required in Outpatient Care Delivery Mechanisms. 6APC Model #14: 2-3. 1k. 7 Elizabeth A. Lee, "Health Education," Hospitals...within Appendix K. A complete inventory of clinical settings was then assembled, and utilizing a random numbers table, gross numbers of patient...are aimed at most of the major seg- I. ments of the patient beneficiary population, while addressing a well balanced inventory of subject matter. In

A random walk rule for phase I clinical trials.

PubMed

Durham, S D; Flournoy, N; Rosenberger, W F

1997-06-01

We describe a family of random walk rules for the sequential allocation of dose levels to patients in a dose-response study, or phase I clinical trial. Patients are sequentially assigned the next higher, same, or next lower dose level according to some probability distribution, which may be determined by ethical considerations as well as the patient's response. It is shown that one can choose these probabilities in order to center dose level assignments unimodally around any target quantile of interest. Estimation of the quantile is discussed; the maximum likelihood estimator and its variance are derived under a two-parameter logistic distribution, and the maximum likelihood estimator is compared with other nonparametric estimators. Random walk rules have clear advantages: they are simple to implement, and finite and asymptotic distribution theory is completely worked out. For a specific random walk rule, we compute finite and asymptotic properties and give examples of its use in planning studies. Having the finite distribution theory available and tractable obviates the need for elaborate simulation studies to analyze the properties of the design. The small sample properties of our rule, as determined by exact theory, compare favorably to those of the continual reassessment method, determined by simulation.

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 randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PubMed

Jose, Anto; Siddiqi, Muhammad; Cronin, Matthew; DiLauro, Thomas S; Bosma, Mary Lynn

2016-02-01

This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial.

PubMed

Han, Ji Won; Son, Kyung Lak; Byun, Hye Jin; Ko, Ji Won; Kim, Kayoung; Hong, Jong Woo; Kim, Tae Hyun; Kim, Ki Woong

2017-06-06

Spaced retrieval training (SRT) is a nonpharmacological intervention for mild cognitive impairment (MCI) and dementia that trains the learning and retention of target information by recalling it over increasingly long intervals. We recently developed the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program as a convenient, self-administered tablet-based SRT program. We also demonstrated the utility of USMART for improving memory in individuals with MCI through an open-label uncontrolled trial. This study had an open-label, single-blind, randomized, controlled, two-period crossover design. Fifty patients with MCI were randomized into USMART-usual care and usual care-USMART treatment sequences. USMART was completed or usual care was provided biweekly over a 4-week treatment period with a 2-week washout period between treatment periods. Primary outcome measures included the Word List Memory Test, Word List Recall Test (WLRT), and Word List Recognition Test. Outcomes were measured at baseline, week 5, and week 11 by raters who were blinded to intervention type. An intention-to-treat analysis and linear mixed modeling were used. Of 50 randomized participants, 41 completed the study (18% dropout rate). The USMART group had larger improvements in WLRT score (effect size = 0.49, p = 0.031) than the usual care group. There were no significant differences in other primary or secondary measures between the USMART and usual care groups. Moreover, no USMART-related adverse events were reported. The 4-week USMART modestly improved information retrieval in older people with MCI, and was well accepted with minimal technical support. ClinicalTrials.gov NCT01688128 . Registered 12 September 2012.

A randomized, controlled trial of bright light therapy for agitated behaviors in dementia patients residing in long-term care.

PubMed

Lyketsos, C G; Lindell Veiel, L; Baker, A; Steele, C

1999-07-01

Agitated behaviors are common in dementia patients residing in chronic care settings. Their occurrence may be associated with lack of adequate exposure to sunlight and with circadian rhythm disturbances. Prior research has suggested that bright light therapy (BLT) may reduce agitated behaviors in dementia patients. The aim of this study was to test the efficacy of BLT in a randomized, controlled, crossover clinical trial. Fifteen patients with dementia and agitated behaviors residing in a chronic care facility were randomized in a crossover design to morning BLT for 1 hour per day or to a control condition with dim light exposure. Patients were treated in either condition for 4 weeks, followed by 1 week on no treatment, prior to being crossed over to the other condition. Eight out of 15 patients completed the entire study. The rest completed at least 2 weeks of study. Patients randomized to the BLT condition exhibited a statistically significant improvement in nocturnal sleep from a mean of 6.4 hours/night to 8.1 hours/night 4 weeks later (p<0.05). The sleep of patients in the control condition did not improve significantly. There were no other significant differences between baseline and follow-up, nor between BLT and control treated patients on the other outcome measures, which included the Behavioral Pathology in Alzheimer Disease scale (Behave-AD) and the Cornell Scale for Depression in Dementia. Patients with dementia in chronic care who exhibit agitated behaviors sleep more hours at night when administered morning BLT. However, BLT does not lead to improvements in agitated behaviors in institutionalized patients with dementia with non-disturbed sleep-wake cycles. Copyright 1999 John Wiley & Sons, Ltd.

Feasibility of a clinical trial of vision therapy for treatment of amblyopia.

PubMed

Lyon, Don W; Hopkins, Kristine; Chu, Raymond H; Tamkins, Susanna M; Cotter, Susan A; Melia, B Michele; Holmes, Jonathan M; Repka, Michael X; Wheeler, David T; Sala, Nicholas A; Dumas, Janette; Silbert, David I

2013-05-01

We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

Feasibility of a Clinical Trial of Vision Therapy for Treatment of Amblyopia

PubMed Central

Lyon, Don W.; Hopkins, Kristine; Chu, Raymond H.; Tamkins, Susanna M.; Cotter, Susan A.; Melia, B. Michele; Holmes, Jonathan M.; Repka, Michael X.; Wheeler, David T.; Sala, Nicholas A.; Dumas, Janette; Silbert, David I.

2013-01-01

Purpose We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. Methods A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, 7 to less than 13 years of age, with amblyopia (20/40–20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. Results Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. Conclusions This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis, might be required to allow enrollment of a broader group of subjects. PMID:23563444

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

PubMed

Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

PubMed Central

Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

2014-01-01

Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

Addressing People and Place Microenvironments in Weight Loss Disparities (APP-Me): Design of a randomized controlled trial testing timely messages for weight loss behavior in low income black and white women

PubMed Central

Clark, Daniel O.; Srinivas, Preethi; Bodke, Kunal; Keith, NiCole; Hood, Sula; Tu, Wanzhu

2018-01-01

Background Behavioral interventions for weight loss have been less effective in lower income and black women. These poorer outcomes may in part be related to these women having more frequent exposures to social and physical situations that are obesogenic, i.e., eating and sedentary cues or situations. Objectives Working with obese, lower income black and white women, Addressing People and Place Microenvironments (APP-Me) was designed to create awareness of self-behavior at times and places of frequent eating and sedentary behavior. Design APP-Me is being evaluated in a randomized controlled trial with 240 participants recruited from federally qualified health centers located in a single Midwestern city. All participants complete four weeks of ecological momentary assessments (EMA) of situations and behavior. At the end of the four weeks, participants are randomized to enhanced usual care (UC) or UC plus APP-Me. Methods APP-Me is an automated short messaging system (SMS). Messages are text, image, audio, or a combination, and are delivered to participants’ mobile devices with the intent of creating awareness at the times and places of frequent eating or sedentary behavior. Summary This project aims to create and test timely awareness messages in a subpopulation that has not responded well to traditional behavioral interventions for weight loss. Novel aspects of the study include the involvement of a low income population, the use of data on time and place of obesogenic behavior, and message delivery time tailored to an individual’s behavioral patterns. PMID:29357313

Simulation-Based Abdominal Ultrasound Training - A Systematic Review.

PubMed

Østergaard, M L; Ewertsen, C; Konge, L; Albrecht-Beste, E; Bachmann Nielsen, M

2016-06-01

The aim is to provide a complete overview of the different simulation-based training options for abdominal ultrasound and to explore the evidence of their effect. This systematic review was performed according to the PRISMA guidelines and Medline, Embase, Web of Science, and the Cochrane Library was searched. Articles were divided into three categories based on study design (randomized controlled trials, before-and-after studies and descriptive studies) and assessed for level of evidence using the Oxford Centre for Evidence Based Medicine (OCEBM) system and for bias using the Cochrane Collaboration risk of bias assessment tool. Seventeen studies were included in the analysis: four randomized controlled trials, eight before-and-after studies with pre- and post-test evaluations, and five descriptive studies. No studies scored the highest level of evidence, and 14 had the lowest level. Bias was high for 11 studies, low for four, and unclear for two. No studies used a test with established evidence of validity or examined the correlation between obtained skills on the simulators and real-life clinical skills. Only one study used blinded assessors. The included studies were heterogeneous in the choice of simulator, study design, participants, and outcome measures, and the level of evidence for effect was inadequate. In all studies simulation training was equally or more beneficial than other instructions or no instructions. Study designs had significant built-in bias and confounding issues; therefore, further research should be based on randomized controlled trials using tests with validity evidence and blinded assessors. © Georg Thieme Verlag KG Stuttgart · New York.

Development and testing of an iOS waiting room "app" for contraceptive counseling in a Title X family planning clinic.

PubMed

Gilliam, Melissa L; Martins, Summer L; Bartlett, Emily; Mistretta, Stephanie Q; Holl, Jane L

2014-11-01

Long-acting reversible contraceptive (LARC) methods, such as the intrauterine device and implant, are highly effective but used by less than 10% of US women. The objective of our study was to improve LARC interest by enhancing clinic counseling. A quality improvement methodology was used to evaluate intrauterine device service delivery in 3 Chicago Title X clinics. To address identified barriers, we developed a theory-based iOS application (app) for patients to use in the clinic waiting room using human-centered design. The final prototype was tested in a randomized controlled trial in a Title X clinic with sexually active females (79% African American) under age 30 years. Our sample of 60 was chosen to detect an increase from 10% (baseline) to 45% (app intervention) in the proportion of patients expressing interest in discussing a LARC method during their clinic visit with 80% power and two-sided α = 0.05. After completing demographic and baseline knowledge questionnaires, participants were randomized 1:1 to intervention (app) or standard care arms. App users also completed a posttest. Our primary outcome was expressed interest in discussing a LARC method during the clinic visit. Secondary outcomes were contraceptive knowledge and LARC selection. App testers (n = 17) preferred interactive, visually appealing design and video testimonials. In the pilot randomized controlled trial (n = 52), app users had a significantly higher knowledge of contraceptive effectiveness (P = .0001) and increased interest in the implant (7.1-32.1%, P = .02) after the intervention. Users were highly satisfied with the app. Staff reported no problems using the app in the clinic. Use of a theory-based counseling app offers a novel method to optimize wait time while minimizing clinic flow disruption. Preliminary data demonstrate that app use was associated with improvements in patients' contraceptive knowledge and interest in the implant. Copyright © 2014 Elsevier Inc. All rights reserved.

Building Networks for Global Clinical Research: The Basics.

PubMed

Shearer, David W; Volberding, Paul A; Schemitsch, Emil H; Cook, Gillian E; Slobogean, Gerard P; Morshed, Saam

2015-12-01

Over the last several decades, interest in global health across all fields of medicine, including orthopaedic surgery, has grown markedly. Cross-national collaborations are an effective means of conducting high-quality clinical research and offer many advantages over single-center investigations. Successful collaboration requires a well-designed research protocol, development of an effective team structure, and the funding to ensure the project is sustained to completion. Equally important, investigators must consider the social, linguistic, and cultural context in which the study is being undertaken. Although randomized clinical trials are the highest level of evidence, study designs may have to be adapted to accommodate available resources, expertise, and local contextual factors. With appropriate planning, these collaborative endeavors can generate changes in clinical practice and positively impact health policy.

In-Person versus Telehealth Assessment of Discourse Ability in Adults with Traumatic Brain Injury

PubMed Central

Turkstra, Lyn S.; Quinn-Padron, Maura; Johnson, Jacqueline E.; Workinger, Marilyn S.; Antoniotti, Nina

2011-01-01

Objectives To compare in-person (IP) vs. telehealth (TH) assessment of discourse ability in adults with chronic traumatic brain injury (TBI). Design Repeated-measures design with random order of conditions. Participants Twenty adults with moderate-to-severe TBI. Method Participants completed conversation, picture description, story-generation, and procedural description tasks. Sessions were video-recorded and transcribed. Measures Measures of productivity and quality of discourse. Results Significant differences between conditions were not detected in this sample, and feedback from participants was positive. Conclusions These preliminary results support the use of TH for the assessment of discourse ability in adults with TBI, at least for individuals with sufficient cognitive skills to follow TH procedures. PMID:22190010

Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study.

PubMed

Gafos, Mitzy; Brodnicki, Elizabeth; Desai, Monica; McCormack, Sheena; Nutland, Will; Wayal, Sonali; White, Ellen; Wood, Gemma; Barber, Tristan; Bell, Gill; Clarke, Amanda; Dolling, David; Dunn, David; Fox, Julie; Haddow, Lewis; Lacey, Charles; Nardone, Anthony; Quinn, Killian; Rae, Caroline; Reeves, Iain; Rayment, Michael; White, David; Apea, Vanessa; Ayap, Wilbert; Dewsnap, Claire; Collaco-Moraes, Yolanda; Schembri, Gabriel; Sowunmi, Yinka; Horne, Rob

2017-01-01

PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design. Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants. Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported 'being deferred' as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design. The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in this study.

Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm Randomized Controlled Trial

PubMed Central

Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

2014-01-01

Background Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. Objective The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. Methods The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months. Results Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation). Conclusions This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change. Trial Registration Clinicaltrials.gov NCT00148525; http://clinicaltrials.gov/ct2/show/NCT00148525 (Archived by Webcite at http://www.webcitation.org/6TiRriJOs). PMID:25387065

The impact of dose escalation and resistance modulation in older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome: the results of the LRF AML14 trial.

PubMed

Burnett, Alan K; Milligan, Donald; Goldstone, Anthony; Prentice, Archibald; McMullin, Mary-Frances; Dennis, Michael; Sellwood, Elizabeth; Pallis, Monica; Russell, Nigel; Hills, Robert K; Wheatley, Keith

2009-05-01

The acute myeloid leukaemia (AML)14 trial addressed four therapeutic questions in patients predominantly aged over 60 years with AML and High Risk Myelodysplastic Syndrome: (i) Daunorubicin 50 mg/m(2) vs. 35 mg/m(2); (ii) Cytarabine 200 mg/m(2) vs. 400 mg/m(2) in two courses of DA induction; (iii) for part of the trial, patients allocated Daunorubicin 35 mg/m(2) were also randomized to receive, or not, the multidrug resistance modulator PSC-833 in a 1:1:1 randomization; and (iv) a total of three versus four courses of treatment. A total of 1273 patients were recruited. The response rate was 62% (complete remission 54%, complete remission without platelet/neutrophil recovery 8%); 5-year survival was 12%. No benefits were observed in either dose escalation randomization, or from a fourth course of treatment. There was a trend for inferior response in the PSC-833 arm due to deaths in induction. Multivariable analysis identified cytogenetics, presenting white blood count, age and secondary disease as the main predictors of outcome. Although patients with high Pgp expression and function had worse response and survival, this was not an independent prognostic factor, and was not modified by PSC-833. In conclusion, these four interventions have not improved outcomes in older patients. New agents need to be explored and novel trial designs are required to maximise prospects of achieving timely progress.

A randomized controlled trial to assess the pain associated with the debond of orthodontic fixed appliances

PubMed Central

Mangnall, Louise A R; Dietrich, Thomas; Scholey, John M

2013-01-01

Objective: To determine patient experience of pain during treatment with fixed orthodontic appliances, expectations of pain during debond and whether biting on a soft acrylic wafer during debond decreases pain experience. Design: Multicentre randomized controlled trial. Setting: Three UK hospital based orthodontic departments: Mid-Staffordshire NHS Foundation Trust, Birmingham Dental Hospital and University Hospital of North Staffordshire. Materials and methods: Ninety patients were randomly allocated to either the control (n = 45) or wafer group (n = 45). A visual analogue scale-based questionnaire was completed pre-debond to determine pain experience during treatment and expectations of pain during debond. The appliances were debonded and those in the wafer group bit on a soft acrylic wafer. A second questionnaire was completed post-debond to assess the pain experienced. Results: Biting on an acrylic wafer significantly reduced the pain experienced when debonding the posterior teeth (P≤0·05). Thirty-nine per cent found the lower anterior teeth the most painful. The expected pain was significantly greater than that actually experienced (P≤0·0001). Greater pain during treatment correlated with increased expectations and increased actually experienced pain (P≤0·0001). Conclusions: Biting on a soft acrylic wafer during debond of the posterior teeth reduces the pain experienced. The lower anterior teeth are the most painful. The pain expected is significantly greater than actually experienced. Patients who had greater pain during treatment expected and experienced greater pain at debond. PMID:24009318

Brief hypnotherapeutic-behavioral intervention for functional abdominal pain and irritable bowel syndrome in childhood: a randomized controlled trial.

PubMed

Gulewitsch, Marco Daniel; Müller, Judith; Hautzinger, Martin; Schlarb, Angelika Anita

2013-08-01

Functional abdominal pain and irritable bowel syndrome are two prevalent disorders in childhood which are associated with recurrent or chronic abdominal pain, disabilities in daily functioning, and reduced quality of life. This study aimed to evaluate a brief hypnotherapeutic-behavioral intervention program in a prospective randomized controlled design. Thirty-eight children, 6 to 12 years of age, and their parents were randomly assigned to a standardized hypnotherapeutic-behavioral treatment (n = 20) or to a waiting list condition (n = 18). Both groups were reassessed 3 months after beginning. Primary outcome variables were child-completed pain measures and pain-related disability. Secondary outcome variables were parent-completed measures of their children's pain and pain-related disability. Health-related quality of life from both perspectives also served as a secondary outcome. In the treatment group, 11 of 20 children (55.0%) showed clinical remission (>80% improvement), whereas only one child (5.6%) in the waiting list condition was classified as responder. Children in the treatment group reported a significantly greater reduction of pain scores and pain-related disability than children of the waiting list condition. Parental ratings also showed a greater reduction of children's abdominal pain and pain-related disability. Health-related quality of life did not increase significantly. Hypnotherapeutic and behavioral interventions are effective in treating children with long-standing AP. Treatment success of this brief program should be further evaluated against active interventions with a longer follow-up.

Outcome of patients after lower limb fracture with partial weight bearing postoperatively treated with or without anti-gravity treadmill (alter G®) during six weeks of rehabilitation - a protocol of a prospective randomized trial.

PubMed

Henkelmann, Ralf; Schneider, Sebastian; Müller, Daniel; Gahr, Ralf; Josten, Christoph; Böhme, Jörg

2017-03-14

Partial or complete immobilization leads to different adjustment processes like higher risk of muscle atrophy or a decrease of general performance. The present study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau (group 1)or ankle fractures (group 2) with six weeks of partial weight bearing of 20 kg. This prospective randomized study will include a total of 60 patients for each group according to predefined inclusion and exclusion criteria. 1:1 randomization will be performed centrally via fax supported by the Clinical Trial Centre Leipzig (ZKS Leipzig). Patients in the treatment arm will be treated with an anti-gravity treadmill (alter G®) instead of physiotherapy. The protocol is designed parallel to standard physiotherapy with a frequency of two to three times of training with the treadmill per week with duration of 20 min for six weeks. Up to date no published randomized controlled trial with an anti-gravity treadmill is available. The findings of this study can help to modify rehabilitation of patients with partial weight bearing due to their injury or postoperative protocol. It will deliver interesting results if an anti-gravity treadmill is useful in rehabilitation in those patients. Further ongoing studies will identify different indications for an anti-gravity treadmill. Thus, in connection with those studies, a more valid statement regarding safety and efficacy is possible. NCT02790229 registered on May 29, 2016.

Design and Methods of a Randomized Trial of Continuous Glucose Monitoring in Persons With Type 1 Diabetes With Impaired Glycemic Control Treated With Multiple Daily Insulin Injections (GOLD Study).

PubMed

Lind, Marcus; Polonsky, William; Hirsch, Irl B; Heise, Tim; Bolinder, Jan; Dahlqvist, Sofia; Pehrsson, Nils-Gunnar; Moström, Peter

2016-05-01

The majority of individuals with type 1 diabetes today have glucose levels exceeding guidelines. The primary aim of this study was to evaluate whether continuous glucose monitoring (CGM), using the Dexcom G4 stand-alone system, improves glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections (MDI). Individuals with type 1 diabetes and inadequate glycemic control (HbA1c ≥ 7.5% = 58 mmol/mol) treated with MDI were randomized in a cross-over design to the Dexcom G4 versus conventional care for 6 months followed by a 4-month wash-out period. Masked CGM was performed before randomization, during conventional treatment, and during the wash-out period to evaluate effects on hypoglycemia, hyperglycemia, and glycemic variability. Questionnaires were used to evaluate diabetes treatment satisfaction, fear of hypoglycemia, hypoglycemia confidence, diabetes-related distress, overall well-being, and physical activity during the different phases of the trial. The primary endpoint was the difference in HbA1c at the end of each treatment phase. A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016. It is expected that the results of this study will establish whether using the Dexcom G4 stand-alone system in individuals with type 1 diabetes treated with MDI improves glycemic control, reduces hypoglycemia, and influences quality-of-life indicators and glycemic variability. © 2016 Diabetes Technology Society.

The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial: a community-based participatory research (CBPR) trial with African-American church congregations for reducing cardiovascular disease risk factors--recruitment, measurement, and randomization.

PubMed

DeHaven, Mark J; Ramos-Roman, Maria A; Gimpel, Nora; Carson, JoAnn; DeLemos, James; Pickens, Sue; Simmons, Chris; Powell-Wiley, Tiffany; Banks-Richard, Kamakki; Shuval, Kerem; Duvahl, Julie; Duval, Julie; Tong, Liyue; Hsieh, Natalie; Lee, Jenny J

2011-09-01

Although cardiovascular diseases (CVD) are the leading cause of death among Americans, significant disparities persist in CVD prevalence, morbidity, and mortality based on race and ethnicity. However, few studies have examined risk factor reduction among the poor and ethnic minorities. Community-based participatory research (CBPR) study using a cluster randomized design--African-American church congregations are the units of randomization and individuals within the congregations are the units of analysis. Outcome variables include dietary change (Diet History Questionnaire), level of physical activity (7-Day Physical Activity Recall), lipoprotein levels, blood pressure, fasting glucose, and hemoglobin A1c. Eighteen (18) church congregations were randomized to either a health maintenance intervention or a control condition. Complete data were obtained on 392 African-American individuals, 18 to 70 years of age, predominantly employed women with more than a high school diploma. Treatment and intervention groups were similar at baseline on saturated fat intake, metabolic equivalent of tasks (METS) per day, and other risk factors for CVD. The GoodNEWS trial successfully recruited and evaluated CVD-related risk among African-American participants using a CBPR approach. Several logistical challenges resulted in extending the recruitment, preliminary training, and measurement periods. The challenges were overcome with the assistance of a local community consultant and a professional event planner. Our experience supports the need for incorporating non-traditional community-based staff into the design and operational plan of CBPR trials. Copyright © 2011 Elsevier Inc. All rights reserved.

Impact of a health promotion intervention on maternal depressive symptoms at 15 months postpartum.

PubMed

Surkan, Pamela J; Gottlieb, Barbara R; McCormick, Marie C; Hunt, Anne; Peterson, Karen E

2012-01-01

Given that diet, physical activity, and social support are associated with depression, we examined whether a health promotion intervention designed to modify these factors in low-income, postpartum women would reduce depressive symptoms. This study used a randomized, controlled design to examine the effect of the Just for You (JFY) Program, an educational intervention promoting healthy lifestyles through home visits by nutrition paraprofessionals and motivational telephone counseling, on postpartum depressive symptoms. A total of 679 women income-eligible for the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) were recruited at 6-20 weeks post delivery and randomized to Usual WIC Care or JFY. Using an intention-to-treat analysis, the authors modeled depressive symptoms on the Center for Epidemiologic Studies Depression Scale (CES-D) among 403 women (59%) completing follow-up at a mean of 15 months infant age, adjusting for baseline CES-D, age, household income and randomization strata (body mass index (BMI), race/region). As a secondary analysis, the authors evaluated potential mediators related to social support and self-efficacy to change one or more health behaviors targeted by the intervention. Women randomized to JFY reported 2.5 units lower CES-D score (P = 0.046) compared with those receiving Usual WIC Care alone. This relationship was attenuated by change in self-efficacy (β = -2.3; P = 0.065), suggesting this construct may partially have mediated the effect of JFY on maternal depressive symptoms. A health promotion intervention delivered through home visits and telephone calls can reduce depressive symptoms at 15 months postpartum among low-income, ethnically diverse women.

The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study.

PubMed

Roberts, Matthew A; Pilmore, Helen L; Ierino, Francesco L; Badve, Sunil V; Cass, Alan; Garg, Amit X; Hawley, Carmel M; Isbel, Nicole M; Krum, Henry; Pascoe, Elaine M; Tonkin, Andrew M; Vergara, Liza A; Perkovic, Vlado

2015-03-01

The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study aims to determine the feasibility of a large-scale randomized controlled trial with clinical endpoints comparing the beta-blocking agent carvedilol with placebo in patients receiving dialysis. The BLOCADE Feasibility Study is a randomized, double-blind, placebo-controlled, parallel group feasibility study comparing the beta-blocking agent carvedilol with placebo. Patients receiving dialysis for ≥3 months and who are aged ≥50 years, or who are ≥18 years and have diabetes or cardiovascular disease, were eligible. The primary outcome was the proportion of participants who complete a 6-week run-in phase in which all participants received carvedilol titrated from 3.125 mg twice daily to 6.25 mg twice daily. Other measures included how many patients are screened, the proportion recruited, the overall recruitment rate, the proportion of participants who remain on study drug for 12 months and the incidence of intra-dialytic hypotension while on randomized treatment. The BLOCADE Feasibility Study commenced recruiting in May 2011 and involves 11 sites in Australia and New Zealand. The BLOCADE Feasibility Study will inform the design of a larger clinical endpoint study to determine whether beta-blocking agents provide benefit to patients receiving dialysis, and define whether such a study is feasible. © 2014 Asian Pacific Society of Nephrology.

The Minnesota Green Tea Trial (MGTT), a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: Study rationale, design, methods, and participant characteristics

PubMed Central

Samavat, Hamed; Dostal, Allison M.; Wang, Renwei; Bedell, Sarah; Emory, Tim H.; Ursin, Giske; Torkelson, Carolyn J.; Gross, Myron D.; Le, Chap T.; Yu, Mimi C.; Yang, Chung S.; Yee, Douglas; Wu, Anna H.; Yuan, Jian-Min; Kurzer, Mindy S.

2015-01-01

Purpose The Minnesota Green Tea Trial (MGTT) was a randomized, placebo-controlled, double-blinded trial investigating the effect of daily green tea extract consumption for 12 months on biomarkers of breast cancer risk. Methods Participants were healthy postmenopausal women at high risk of breast cancer due to dense breast tissue with differing catechol-O-methyltransferase (COMT) genotypes. The intervention was a green tea catechin extract containing 843.0 ± 44.0 mg/day epigallocatechin gallate or placebo capsules for one year. Annual digital screening mammograms were obtained at baseline and month 12, and fasting blood and 24-hour urine samples were provided at baseline, months 6, and 12. Primary endpoints included changes in percent mammographic density, circulating endogenous sex hormones and insulin-like growth factor axis proteins; secondary endpoints were changes in urinary estrogens and estrogen metabolites and circulating F2-isoprostanes, a biomarker of oxidative stress. Results The MGTT screened more than 100,000 mammograms and randomized 1075 participants based on treatment (green tea extract vs. placebo), stratified by COMT genotype activity (high COMT vs. low/intermediate COMT genotype activity). 937 women successfully completed the study and 138 dropped out (overall dropout rate= 12.8%). Conclusions In this paper we report the rationale, design, recruitment, participant characteristics, and methods for biomarker and statistical analyses. PMID:26206423

Evaluating Data Abstraction Assistant, a novel software application for data abstraction during systematic reviews: protocol for a randomized controlled trial.

PubMed

Saldanha, Ian J; Schmid, Christopher H; Lau, Joseph; Dickersin, Kay; Berlin, Jesse A; Jap, Jens; Smith, Bryant T; Carini, Simona; Chan, Wiley; De Bruijn, Berry; Wallace, Byron C; Hutfless, Susan M; Sim, Ida; Murad, M Hassan; Walsh, Sandra A; Whamond, Elizabeth J; Li, Tianjing

2016-11-22

Data abstraction, a critical systematic review step, is time-consuming and prone to errors. Current standards for approaches to data abstraction rest on a weak evidence base. We developed the Data Abstraction Assistant (DAA), a novel software application designed to facilitate the abstraction process by allowing users to (1) view study article PDFs juxtaposed to electronic data abstraction forms linked to a data abstraction system, (2) highlight (or "pin") the location of the text in the PDF, and (3) copy relevant text from the PDF into the form. We describe the design of a randomized controlled trial (RCT) that compares the relative effectiveness of (A) DAA-facilitated single abstraction plus verification by a second person, (B) traditional (non-DAA-facilitated) single abstraction plus verification by a second person, and (C) traditional independent dual abstraction plus adjudication to ascertain the accuracy and efficiency of abstraction. This is an online, randomized, three-arm, crossover trial. We will enroll 24 pairs of abstractors (i.e., sample size is 48 participants), each pair comprising one less and one more experienced abstractor. Pairs will be randomized to abstract data from six articles, two under each of the three approaches. Abstractors will complete pre-tested data abstraction forms using the Systematic Review Data Repository (SRDR), an online data abstraction system. The primary outcomes are (1) proportion of data items abstracted that constitute an error (compared with an answer key) and (2) total time taken to complete abstraction (by two abstractors in the pair, including verification and/or adjudication). The DAA trial uses a practical design to test a novel software application as a tool to help improve the accuracy and efficiency of the data abstraction process during systematic reviews. Findings from the DAA trial will provide much-needed evidence to strengthen current recommendations for data abstraction approaches. The trial is registered at National Information Center on Health Services Research and Health Care Technology (NICHSR) under Registration # HSRP20152269: https://wwwcf.nlm.nih.gov/hsr_project/view_hsrproj_record.cfm?NLMUNIQUE_ID=20152269&SEARCH_FOR=Tianjing%20Li . All items from the World Health Organization Trial Registration Data Set are covered at various locations in this protocol. Protocol version and date: This is version 2.0 of the protocol, dated September 6, 2016. As needed, we will communicate any protocol amendments to the Institutional Review Boards (IRBs) of Johns Hopkins Bloomberg School of Public Health (JHBSPH) and Brown University. We also will make appropriate as-needed modifications to the NICHSR website in a timely fashion.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

PubMed

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-08-01

Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial

PubMed Central

Parvizi, Mohammad Mahdi; Moein, Mahmoodreza; Hatam, Gholamreza; Nimrouzi, Majid; Hassanzadeh, Jafar; Hamidizadeh, Nasrin; Khorrami, Hamid Reza; Zarshenas, Mohammad Mehdi

2017-01-01

Background Cutaneous leishmaniasis is one of the highly prevalent endemic diseases in the Middle East and North Africa. Many treatment modalities have been recommended for this condition but success rates remain limited. Herbal remedies have also been used for treatment but evidence-based clinical trials with these products are sparse. In-vitro and in-vivo studies have shown the anti-leishmanial and curative effects of extract of fruits and leaves of Juniperus excelsa (J. excelsa). The aim of this study was to determine the efficacy of topical J. excelsa M. Bieb extract as an adjuvant to cryotherapy for the treatment of human CL. Materials and methods This study was designed as a two-arm triple-blind randomized placebo-controlled clinical trial using a parallel design. Seventy-two patients with clinical diagnosis of CL confirmed by leishmania smears were allocated to receive either a topical formulation of leaf of J. excelsa extract (group A) or placebo (group B) for 3 months. Both groups received cryotherapy as baseline standard treatment. Patients were evaluated before and weekly after the intervention was initiated until complete cure. Results Overall, 82% of patients in group A, experienced complete cure and 9% of them had partial cure. On the other hand, 34% in group B reported complete cure, while 14% of them had partial cure at the end of treatment protocol with a significant difference between the two groups (P< 0.001). The mean duration to healing of the lesions in patients who received J. excelsa extract was statistically significantly shorter than the placebo group (p = 0.04). No significant side effect was seen in the J. excelsa extract group except for mild to moderate local irritation after a few weeks in a few numbers of patients. Conclusion The results of this study showed that topical J. excelsa extract can be used as an adjuvant treatment modality in addition to cryotherapy for accelerating the time to cure in addition to increasing the complete cure rate in CL. Trial registration ClinicalTrials.gov IRCT2015082523753N1 PMID:28981503

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

PubMed

Brubaker, Linda; Litman, Heather J; Kim, Hae-Young; Zimmern, Philippe; Dyer, Keisha; Kusek, John W; Richter, Holly E; Stoddard, Anne

2015-08-01

Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

Comparison of positive pressure gloves on hand function in adults with burns.

PubMed

O'Brien, Kimberly A; Weinstock-Zlotnick, Gwen; Hunter, Hope; Yurt, Roger W

2006-01-01

The purpose of this study was to analyze the impact of a standard, custom-made pressure glove vs The NewYork-Presbyterian Dexterity Glove (NYPDG) with silon application on the palmer surface on functional hand use of burn survivors. A standard, custom-made pressure glove and NYPDG were given to 18 participants in a randomized order. Subjects wore each glove for 7 to 10 days during all activities of daily living (ADL). Variables such as hand function, difficulty of fine and gross motor ADL, and participant glove preference were assessed with each glove condition. Data collection of the second glove took place 7 to 10 days later incorporating a quasiexperimental, repeated measure design. A crossover design was used to analyze the data. The NYPDG demonstrated significantly better results in all of the four outcome categories measured: time to complete the Jebsen, the Jebsen Likert scale, fine motor ADL, and gross motor ADL. This study demonstrated that functional tasks took less time to complete and were more easily performed when using the NYPDG.

Effects of temperature and photoperiod on postponing bermudagrass (Cynodon dactylon [L.] Pers.) turf dormancy.

PubMed

Esmaili, Somayeh; Salehi, Hassan

2012-06-15

Growth chamber and field experiments were carried out to determine the effects of extended photoperiod under low and freezing temperatures on bermudagrass turf dormancy at Bajgah, in the southern part of Iran. The experiment in the growth chamber was conducted with four temperature regimes (15, 7.5, 0 and -7.5°C) and three light durations (8, 12 and 16h) in a completely randomized design with four replications. The field study was conducted in two consecutive years (2008-2009) with three light durations (8, 12 and 16h) in months with natural short day length and arranged in a randomized complete blocks design with three replications. Results in both experiments showed that decreasing temperature and photoperiod decreased verdure fresh and dry weight, shoot height, tiller density, leaf area and chlorophyll and relative water contents (RWC). However, rooting depth and fresh weight of roots increased in the growth chamber. Decreasing the temperature and light duration increased electrolyte leakage and proline content. Reducing sugars increased with decreasing temperature and declined with lowering light duration in both shoots and roots. Starch content of both shoots and roots showed an adverse trend compared to reducing sugars; starch content increased in both shoots and roots in all treatments by shortening the photoperiod. Practically, the problem of bermudagrass turf's dormancy could be solved via increasing the photoperiod in months with short day lengths. This treatment would be efficient and useful for turfgrass managers to apply in landscapes and stadiums. Copyright © 2012 Elsevier GmbH. All rights reserved.

Telehealth Protocol to Prevent Readmission Among High-Risk Patients With Congestive Heart Failure.

PubMed

Rosen, Daniel; McCall, Janice D; Primack, Brian A

2017-11-01

Congestive heart failure is the leading cause of hospital readmissions. We aimed to assess adherence to and effectiveness of a telehealth protocol designed to prevent hospital admissions for congestive heart failure. We recruited a random sample of 50 patients with congestive heart failure (mean age 61 years) from a managed care organization. We developed a telehealth platform allowing for daily, real-time reporting of health status and video conferencing. We defined adherence as the percentage of days on which the patient completed the daily check-in protocol. To assess efficacy, we compared admission and readmission rates between the 6-month intervention period and the prior 6 months. Primary outcomes were admissions and readmissions due to congestive heart failure, and secondary outcomes were admissions and readmissions due to any cause. Forty-eight patients (96%) completed the protocol. Approximately half (46%) were at high risk for readmission according to standardized measures. Median 120-day adherence was 96% (interquartile range, 92%-98%), and adherence did not significantly differ across sex, race, age, living situation, depression, cognitive ability, or risk for readmission. Approximately equal proportions of patients were admitted for all causes during the 6-month intervention period versus the comparison period (37% vs 43%; P = .32). Half as many patients were admitted for congestive heart failure during the 6-month intervention period compared with the comparison period (12% vs 25%; P = .11). Adherence to this telehealth protocol was excellent and consistent, even among high-risk patients. Future research should test the protocol using a more rigorous randomized design. Copyright © 2017 Elsevier Inc. All rights reserved.

Effectiveness of nursing management information systems: a systematic review.

PubMed

Choi, Mona; Yang, You Lee; Lee, Sun-Mi

2014-10-01

The purpose of this study was to review evaluation studies of nursing management information systems (NMISs) and their outcome measures to examine system effectiveness. For the systematic review, a literature search of the PubMed, CINAHL, Embase, and Cochrane Library databases was conducted to retrieve original articles published between 1970 and 2014. Medical Subject Headings (MeSH) terms included informatics, medical informatics, nursing informatics, medical informatics application, and management information systems for information systems and evaluation studies and nursing evaluation research for evaluation research. Additionally, manag(*) and admin(*), and nurs(*) were combined. Title, abstract, and full-text reviews were completed by two reviewers. And then, year, author, type of management system, study purpose, study design, data source, system users, study subjects, and outcomes were extracted from the selected articles. The quality and risk of bias of the studies that were finally selected were assessed with the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS) criteria. Out of the 2,257 retrieved articles, a total of six articles were selected. These included two scheduling programs, two nursing cost-related programs, and two patient care management programs. For the outcome measurements, usefulness, time saving, satisfaction, cost, attitude, usability, data quality/completeness/accuracy, and personnel work patterns were included. User satisfaction, time saving, and usefulness mostly showed positive findings. The study results suggest that NMISs were effective in time saving and useful in nursing care. Because there was a lack of quality in the reviewed studies, well-designed research, such as randomized controlled trials, should be conducted to more objectively evaluate the effectiveness of NMISs.

Research to Encourage Exercise for Fibromyalgia (REEF): Use of Motivational Interviewing Design and Method

PubMed Central

Ang, Dennis C.; Kaleth, Anthony S.; Bigatti, Silvia; Mazzuca, Steve; Saha, Chandan; Hilligoss, Janna; Lengerich, Mimi; Bandy, Robert

2010-01-01

Fibromyalgia (FM), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, is an illness associated with major personal and societal burden. Supervised aerobic exercise is an important treatment modality to improve patient symptoms. Unfortunately, adherence to an exercise regimen after a structured supervised program is disappointingly low. Since FM is a chronic illness, studies are needed to test strategies that would enhance exercise adherence in these individuals. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. The objective of this paper was to describe the protocol of the Research to Encourage Exercise for Fibromyalgia (REEF). REEF is a randomized attention-controlled trial that seeks to test the efficacy of 6 sessions of telephone delivered motivational interviewing (MI) that targets exercise adherence to improve FM-relevant clinical outcomes (i.e., physical function and pain severity). The trial has recently completed enrolling 216 subjects, and randomization has resulted in well balanced groups. Details on the study design, MI program, and treatment fidelity are provided in the paper. Outcome assessments at week 12, week 24 and week 36 will test the immediate, intermediate and long term effects of exercise-based MI on adherence (as measured by the Community Health Activities Model Program for Seniors/CHAMPS and accelerometer) and clinical outcomes. When completed, REEF will determine whether exercise-based MI could be utilized as a management strategy to sustain the clinical benefits of exercise for FM. PMID:20828634

Research to Encourage Exercise for Fibromyalgia (REEF): use of motivational interviewing design and method.

PubMed

Ang, Dennis C; Kaleth, Anthony S; Bigatti, Silvia; Mazzuca, Steve; Saha, Chandan; Hilligoss, Janna; Lengerich, Mimi; Bandy, Robert

2011-01-01

Fibromyalgia (FM), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, is an illness associated with major personal and societal burden. Supervised aerobic exercise is an important treatment modality to improve patient symptoms. Unfortunately, adherence to an exercise regimen after a structured supervised program is disappointingly low. Since FM is a chronic illness, studies are needed to test strategies that would enhance exercise adherence in these individuals. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. The objective of this paper was to describe the protocol of the Research to Encourage Exercise for Fibromyalgia (REEF). REEF is a randomized attention-controlled trial that seeks to test the efficacy of 6 sessions of telephone delivered motivational interviewing (MI) that targets exercise adherence to improve FM-relevant clinical outcomes (i.e., physical function and pain severity). The trial has recently completed enrolling 216 subjects, and randomization has resulted in well-balanced groups. Details on the study design, MI program, and treatment fidelity are provided in the paper. Outcome assessments at week 12, week 24 and week 36 will test the immediate, intermediate and long-term effects of exercise-based MI on adherence (as measured by the Community Health Activities Model Program for Seniors/CHAMPS and accelerometer) and clinical outcomes. When completed, REEF will determine whether exercise-based MI could be utilized as a management strategy to sustain the clinical benefits of exercise for FM. Copyright © 2010 Elsevier Inc. All rights reserved.

Evaluation of wheat-based thin stillage as a water source for growing and finishing beef cattle.

PubMed

Fisher, D J; McKinnon, J J; Mustafa, A F; Christensen, D A; McCartney, D

1999-10-01

Two trials were conducted to evaluate the nutritional value of wheat-based thin stillage as a water source for cattle. In Trial 1, 20 large-framed steers were fed a basal diet based primarily on barley grain and barley silage, with ad libitum access to water or thin stillage at one of three DM concentrations (2, 4, and 6.7%) in a completely randomized design. The trial consisted of a 70-d growing period and a finishing phase. In Trial 2, total-tract nutrient digestibility coefficients of the basal diet and water treatments fed in the growing period were determined in a randomized complete block design using 12 medium-framed steers. The results showed that when only DMI from the basal diet was considered, there was a linear reduction (P<.01) in DMI and a linear improvement (P<.01) in the gain:feed ratio with no effect on daily gain as thin stillage DM concentration increased. No differences were detected in DMI or efficiency of gain when total DMI (basal diet and thin stillage) was considered. Carcass traits indicated a trend toward increased (P<.06) carcass fat with increasing thin stillage DM concentration. Results of Trial 2 indicated a linear improvement (P<.05) in apparent digestibility of DM, CP, NDF, and energy of the total diet (basal diet and thin stillage) as thin stillage DM concentration increased. We concluded that supplementing growing and finishing cattle with thin stillage reduced the amount of the basal diet required for gain and improved nutrient utilization.

Usability of a Novel Mobile Health iPad App by Vulnerable Populations.

PubMed

Miller, David P; Weaver, Kathryn E; Case, L Doug; Babcock, Donald; Lawler, Donna; Denizard-Thompson, Nancy; Pignone, Michael P; Spangler, John G

2017-04-11

Recent advances in mobile technologies have created new opportunities to reach broadly into populations that are vulnerable to health disparities. However, mobile health (mHealth) strategies could paradoxically increase health disparities, if low socioeconomic status individuals lack the technical or literacy skills needed to navigate mHealth programs. The aim of this study was to determine whether patients from vulnerable populations could successfully navigate and complete an mHealth patient decision aid. We analyzed usability data from a randomized controlled trial of an iPad program designed to promote colorectal cancer (CRC) screening. The trial was conducted in six primary care practices and enrolled 450 patients, aged 50-74 years, who were due for CRC screening. The iPad program included a self-survey and randomly displayed either a screening decision aid or a video about diet and exercise. We measured participant ability to complete the program without assistance and participant-rated program usability. Two-thirds of the participants (305/450) were members of a vulnerable population (limited health literacy, annual income < US $20,000, or black race). Over 92% (417/450) of the participants rated the program highly on all three usability items (90.8% for vulnerable participants vs 96.6% for nonvulnerable participants, P=.006). Only 6.9% (31/450) of the participants needed some assistance to complete the program. In multivariable logistic regression, being a member of a vulnerable population was not associated with needing assistance. Only older age, less use of text messaging (short message service, SMS), and lack of Internet use predicted needing assistance. Individuals who are vulnerable to health disparities can successfully use well-designed mHealth programs. Future research should investigate whether mHealth interventions can reduce health disparities. ©David P Miller Jr, Kathryn E Weaver, L Doug Case, Donald Babcock, Donna Lawler, Nancy Denizard-Thompson, Michael P Pignone, John G Spangler. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 11.04.2017.

Black gram (Vigna Mungo L.) foliage supplementation to crossbred cows: effects on feed intake, nutrient digestibility and milk production

PubMed Central

Dey, Avijit; De, Partha Sarathi; Gangopadhyay, Prabir Kumar

2017-01-01

Objective An experiment was conducted to examine the effect of dietary supplementation of dried and ground foliage of black gram (Vigna mungo L.) on feed intake and utilization, and production performance of crossbred lactating cows. Methods Eighteen lactating crossbred (Bos taurus×Bos indicus) cows (body weight 330.93± 10.82 kg) at their second and mid lactation (milk yield 6.77±0.54 kg/d) were randomly divided into three groups of six each in a completely randomized block design. Three supplements were formulated by quantitatively replacing 0, 50, and 100 per cent of dietary wheat bran of concentrate mixture with dried and ground foliage of black gram. The designated supplement was fed to each group with basal diet of rice straw (ad libitum) to meet the requirements for maintenance and milk production. Daily feed intake and milk yield was recorded. A digestion trial was conducted to determine the total tract digestibility of various nutrients. Results The daily feed intake was increased (p<0.05) with the supplementation of black gram foliage. Although the digestibility of dry matter, organic matter, crude protein, and ether extract did not vary (p>0.05), the fibre digestibility was increased (p<0.05), which ultimately improved (p<0.05) the total digestible nutrients content of composite diet. Although, the average milk yield (kg/animal/d) and composition did not differ (p>0.05) among the groups, milk yield was increased by 10 per cent with total replacement of wheat bran in concentrate mixture with of black gram foliage. The economics of milk production calculated as feed cost per kg milk yield (INR 10.61 vs 7.98) was reduced by complete replacement of wheat bran with black gram foliage. Conclusion Black gram foliage could be used as complete replacement for wheat bran in concentrate mixture of dairy cows in formulating least cost ration for economic milk production in small holders’ animal production. PMID:27282971

On the design of random metasurface based devices.

PubMed

Dupré, Matthieu; Hsu, Liyi; Kanté, Boubacar

2018-05-08

Metasurfaces are generally designed by placing scatterers in periodic or pseudo-periodic grids. We propose and discuss design rules for functional metasurfaces with randomly placed anisotropic elements that randomly sample a well-defined phase function. By analyzing the focusing performance of random metasurface lenses as a function of their density and the density of the phase-maps used to design them, we find that the performance of 1D metasurfaces is mostly governed by their density while 2D metasurfaces strongly depend on both the density and the near-field coupling configuration of the surface. The proposed approach is used to design all-polarization random metalenses at near infrared frequencies. Challenges, as well as opportunities of random metasurfaces compared to periodic ones are discussed. Our results pave the way to new approaches in the design of nanophotonic structures and devices from lenses to solar energy concentrators.

Assessment of the core learning objectives curriculum for the urology clerkship.

PubMed

Rapp, David E; Gong, Edward M; Reynolds, W Stuart; Lucioni, Alvaro; Zagaja, Gregory P

2007-11-01

The traditional approach to the surgical clerkship has limitations, including variability of clinical exposure. To optimize student education we developed and introduced the core learning objectives curriculum, which is designed to allow students freedom to direct their learning and focus on core concepts. We performed a prospective, randomized, controlled study to compare the efficacy of core learning objectives vs traditional curricula through objective and subjective measures. Medical students were randomly assigned to the core learning objectives or traditional curricula during the 2-week urology clerkship. Faculty was blinded to student assignment. Upon rotation completion all students were given a 20-question multiple choice examination covering basic urology concepts. In addition, students completed a questionnaire addressing subjective clerkship satisfaction, comprising 15 questions. Between June 2005 and January 2007, 10 core learning objectives students and 10 traditional students completed the urology clerkship. The average +/- SEM multiple choice examination score was 12.1 +/- 0.87 and 9.8 +/- 0.59 for students assigned to the core learning objectives and traditional curricula, respectively (p <0.05). Subjective scores were higher in the core learning objectives cohort, although this result did not attain statistical significance (124.9 +/- 3.72 vs 114.3 +/- 4.96, p = 0.1). Core learning objectives students reported higher satisfaction in all 15 assessed subjective end points. Our experience suggests that the core learning objectives model may be an effective educational tool to help students achieve a broad and directed exposure to the core urological concepts.

Attrition Bias Related to Missing Outcome Data: A Longitudinal Simulation Study.

PubMed

Lewin, Antoine; Brondeel, Ruben; Benmarhnia, Tarik; Thomas, Frédérique; Chaix, Basile

2018-01-01

Most longitudinal studies do not address potential selection biases due to selective attrition. Using empirical data and simulating additional attrition, we investigated the effectiveness of common approaches to handle missing outcome data from attrition in the association between individual education level and change in body mass index (BMI). Using data from the two waves of the French RECORD Cohort Study (N = 7,172), we first examined how inverse probability weighting (IPW) and multiple imputation handled missing outcome data from attrition in the observed data (stage 1). Second, simulating additional missing data in BMI at follow-up under various missing-at-random scenarios, we quantified the impact of attrition and assessed how multiple imputation performed compared to complete case analysis and to a perfectly specified IPW model as a gold standard (stage 2). With the observed data in stage 1, we found an inverse association between individual education and change in BMI, with complete case analysis, as well as with IPW and multiple imputation. When we simulated additional attrition under a missing-at-random pattern (stage 2), the bias increased with the magnitude of selective attrition, and multiple imputation was useless to address it. Our simulations revealed that selective attrition in the outcome heavily biased the association of interest. The present article contributes to raising awareness that for missing outcome data, multiple imputation does not do better than complete case analysis. More effort is thus needed during the design phase to understand attrition mechanisms by collecting information on the reasons for dropout.

Embedding medical student computer tutorials into a busy emergency department.

PubMed

Pusic, Martin V; Pachev, George S; MacDonald, Wendy A

2007-02-01

To explore medical students' use of computer tutorials embedded in a busy clinical setting; to demonstrate that such tutorials can increase knowledge gain over and above that attributable to the clinical rotation itself. Six tutorials were installed on a computer placed in a central area in an emergency department. Each tutorial was made up of between 33 and 85 screens of information that include text, graphics, animations, and questions. They were designed to be brief (10 minutes), focused, interactive, and immediately relevant. The authors evaluated the intervention using quantitative research methods, including usage tracking, surveys of faculty and students, and a randomized pretest-posttest study. Over 46 weeks, 95 medical students used the tutorials 544 times, for an overall average of 1.7 times a day. The median time spent on completed tutorials was 11 minutes (average [SD], 14 [+/-12] minutes). Seventy-four students completed the randomized study. They completed 65% of the assigned tutorials, resulting in improved examination scores compared with the control (effect size, 0.39; 95% confidence interval = 0.15 to 0.62). Students were positively disposed to the tutorials, ranking them as "valuable." Fifty-four percent preferred the tutorials to small group teaching sessions with a preceptor. The faculty was also positive about the tutorials, although they did not appear to integrate the tutorials directly into their teaching. Medical students on rotation in a busy clinical setting can and will use appropriately presented computer tutorials. The tutorials are effective in raising examination scores.

An intervention to preschool children for reducing screen time: a randomized controlled trial.

PubMed

Yilmaz, G; Demirli Caylan, N; Karacan, C D

2015-05-01

Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.

The Limited Impact of Exposure Duration on Holistic Word Processing.

PubMed

Chen, Changming; Abbasi, Najam Ul Hasan; Song, Shuang; Chen, Jie; Li, Hong

2016-01-01

The current study explored the impact of stimuli exposure duration on holistic word processing measured by the complete composite paradigm (CPc paradigm). The participants were asked to match the cued target parts of two characters which were presented for either a long (600 ms) or a short duration (170 ms). They were also tested by two popular versions of the CPc paradigm: the "early-fixed" task where the attention cue was visible from the beginning of each trial at a fixed position, and the "delayed-random" task where the cue showed up after the study character at random locations. The holistic word effect, as indexed by the alignment × congruency interaction, was identified in both tasks and was unaffected by the stimuli duration in both tasks. Meanwhile, the "delayed-random" task did not bring about larger holistic word effect than the "early-fixed" task. These results suggest the exposure duration (from around 150 to 600 ms) has a limited impact on the holistic word effect, and have methodological implications for experiment designs in this field.

Naproxen or Estradiol for Bleeding and Spotting with the Levonorgestrel Intrauterine System: A Randomized Controlled Trial

PubMed Central

MADDEN, Tessa; PROEHL, Sarah; ALLSWORTH, Jenifer E.; SECURA, Gina M.; PEIPERT, Jeffrey F.

2011-01-01

Objective To evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women initiating the levonorgestrel-releasing intrauterine system (LNG-IUS). Study Design We conducted a randomized controlled trial of naproxen, estradiol, or placebo administered over the first 12 weeks of LNG-IUS use. Participants completed a written bleeding diary. We imputed missing values and performed an intention-to-treat analysis. Results There were 129 women randomized to naproxen (n=42), estradiol (n=44), or placebo (n=43). The naproxen group was more likely to be in the lowest quartile of bleeding and spotting days compared to placebo, 42.9% versus 16.3% (p=0.03). In the multivariable analysis, the naproxen group had a 10% reduction in bleeding and spotting days (RRadj 0.90, 95%CI 0.84–0.97) compared to placebo. More frequent bleeding and spotting was observed in the estradiol group (RRadj 1.25, 95%CI 1.17–1.34). Conclusions Administration of naproxen resulted in a reduction in bleeding and spotting days compared to placebo. (150 words) PMID:22055339

Design and test of a situation-augmented display for an unmanned aerial vehicle monitoring task.

PubMed

Lu, Jen-Li; Horng, Ruey-Yun; Chao, Chin-Jung

2013-08-01

In this study, a situation-augmented display for unmanned aerial vehicle (UAV) monitoring was designed, and its effects on operator performance and mental workload were examined. The display design was augmented with the knowledge that there is an invariant flight trajectory (formed by the relationship between altitude and velocity) for every flight, from takeoff to landing. 56 participants were randomly assigned to the situation-augmented display or a conventional display condition to work on 4 (number of abnormalities) x 2 (noise level) UAV monitoring tasks three times. Results showed that the effects of situation-augmented display on flight completion time and time to detect abnormalities were robust under various workload conditions, but error rate and perceived mental workload were unaffected by the display type. Results suggest that the UAV monitoring task is extremely difficult, and that display devices providing high-level situation-awareness may improve operator monitoring performance.

Evolution of a designed retro-aldolase leads to complete active site remodeling

PubMed Central

Giger, Lars; Caner, Sami; Obexer, Richard; Kast, Peter; Baker, David; Ban, Nenad; Hilvert, Donald

2013-01-01

Evolutionary advances are often fueled by unanticipated innovation. Directed evolution of a computationally designed enzyme suggests that dramatic molecular changes can also drive the optimization of primitive protein active sites. The specific activity of an artificial retro-aldolase was boosted >4,400 fold by random mutagenesis and screening, affording catalytic efficiencies approaching those of natural enzymes. However, structural and mechanistic studies reveal that the engineered catalytic apparatus, consisting of a reactive lysine and an ordered water molecule, was unexpectedly abandoned in favor of a new lysine residue in a substrate binding pocket created during the optimization process. Structures of the initial in silico design, a mechanistically promiscuous intermediate, and one of the most evolved variants highlight the importance of loop mobility and supporting functional groups in the emergence of the new catalytic center. Such internal competition between alternative reactive sites may have characterized the early evolution of many natural enzymes. PMID:23748672

Adapting the buying funnel model of consumer behavior to the design of an online health research recruitment tool.

PubMed

Doshi, Aalap; Connally, Lisa; Spiroff, Meghan; Johnson, Anita; Mashour, George A

2017-08-01

UMHealthResearch is the University of Michigan's digital health research recruitment platform. It allows health researchers to connect efficiently with potentially eligible volunteers. In 2013, the UMHealthResearch team strategically adapted a consumer behavior model, the buying funnel, to create the Digital Health Research Participation Funnel. The Digital Health Research Participation Funnel was then used to design a more active way for potential participants to volunteer for research studies through UMHealthResearch. In the 5 years before the redesign (2007-2012), an average of 1844 new accounts were created every year, whereas in the completed years after the redesign (2013-2016) the annual average improved to 3906, an increase of 111%. Although a randomized design was not possible in this instance, these preintervention and postintervention data suggest that the focus on user experience is an effective strategy for improving web-based research recruitment platforms.

Design of concrete waste basin in Integrated Temporarily Sanitary Landfill (ITSL) in Siosar, Karo Regency, Indonesia on supporting clean environment and sustainable fertilizers for farmers

NASA Astrophysics Data System (ADS)

Ginting, N.; Siahaan, J.; Tarigan, A. P.

2018-03-01

A new settlement in Siosar village of Karo Regency has been developed for people whose villages have been completely destroyed by the prolong eruptions of Sinabung. An integrated temporarily sanitary landfill (ITSL) was built there to support the new living environment. The objective of this study is to investigate the organic waste decomposing in order to improve the design of the conventional concrete waste basin installed in the ITSL. The study was last from May until August 2016. The used design was Completely Randomized Design (CRD) in which organic waste was treated using decomposer with five replications in three composter bins. Decomposting process lasted for three weeks. Research parameters were pH, temperature, waste reduction in weight, C/N, and organic fertilizer production(%). The results of waste compost as follows : pH was 9.45, ultimate temperature was 31.6°C, C/N was in the range of 10.5-12.4, waste reduction was 53% and organic fertilizer production was 47%. Based on the decomposting process and the analysis, it is recommended that the conventional concrete waste basin should be divided into three colums and each column would be filled with waste when previous column is fulled. It is predicted that when the third column is fully occupied then the waste in the first column already become a sustainable fertilizer.

A randomized, blinded, multicenter trial of a gentamicin vancomycin gel (DFA-02) in patients undergoing abdominal surgery.

PubMed

Bennett-Guerrero, Elliott; Berry, Scott M; Bergese, Sergio D; Fleshner, Phillip R; Minkowitz, Harold S; Segura-Vasi, Alvaro M; Itani, Kamal M F; Henderson, Karen W; Rackowski, Felicia P; Aberle, Laura H; Stryjewski, Martin E; Corey, G Ralph; Allenby, Kent S

2017-06-01

SI is a significant medical problem. DFA-02 is an investigational bioresorbable modified release gel consisting of both gentamicin (16.8 mg/mL) and vancomycin (18.8 mg/mL). A Phase 2a study, where the drug was applied during surgical incision closure, suggested safety and tolerability but was not designed to assess its efficacy. In a Phase 2b randomized, blinded trial patients undergoing abdominal, primarily colorectal, surgery were randomized (4:1:1) to one of three study arms: DFA-02, matching placebo gel, or standard of care (SOC) involving irrigation of the wound with normal saline. The DFA-02 and placebo gel groups received up to 20 mL of study drug inserted above the fascia during wound closure, and were treated in a double-blind manner; the SOC group was treated in a single-blind manner. The primary endpoint was SSI (adjudicated centrally by a blinded committee) through postoperative day 30. Overall, 445 subjects (intention-to-treat) were randomized at 35 centers with 425 subjects completing the study and being evaluable. There were 67 SSIs (15.8%): 64.2% superficial, 7.5% deep, and 28.4% organ space. The incidence of SSI was not statistically significantly different between the DFA-02 and the placebo gel/SOC arms combined, 42/287 = 14.6% vs 25/138 = 18.1% (p = 0.36), respectively. Rehospitalization within 30 days was also similar between study groups (DFA-02 28.6%, placebo gel 21.4%, SOC 27.3%). In this multicenter, blinded, randomized trial with central adjudication, the gentamicin/vancomycin gel was not associated with a significant reduction in SSI. Patients undergoing abdominal surgery were randomized to one of three study arms: DFA-02 gel consisting of both gentamicin and vancomycin, matching placebo gel, or standard of care (SOC). Of 425 patients completing the study at 35 sites the gentamicin/vancomycin gel was not associated with a significant reduction in SSI. Copyright © 2016 Elsevier Inc. All rights reserved.

The AIDS Memorial Quilt as preventative education: a developmental analysis of the Quilt.

PubMed

Knaus, C S; Austin, E W

1999-12-01

This study consisted of a survey given to college students (N = 560) at a rural university in the Pacific Northwest. The sample was randomly assigned into four groups, following the Solomon four-group study design. The two levels of treatment included interventions consisting of a visit to the AIDS Memorial Quilt for the experimental groups and attendance at an unrelated event for the control groups. Pretests were completed 4 weeks prior to interventions; posttests were completed by the entire sample 4 weeks after the interventions. Results confirmed expected differences among the four groups in terms of social distance, perceptions of people with AIDS, self-efficacy, and discussion of risky behavior. The results suggest that the AIDS Memorial Quilt addresses issues centrally related to behavior change and indicates support for the message interpretation process and stages of change models.

Realization of the Switching Mechanism in Resistance Random Access Memory™ Devices: Structural and Electronic Properties Affecting Electron Conductivity in a Hafnium Oxide-Electrode System Through First-Principles Calculations

NASA Astrophysics Data System (ADS)

Aspera, Susan Meñez; Kasai, Hideaki; Kishi, Hirofumi; Awaya, Nobuyoshi; Ohnishi, Shigeo; Tamai, Yukio

2013-01-01

The resistance random access memory (RRAM™) device, with its electrically induced nanoscale resistive switching capacity, has attracted considerable attention as a future nonvolatile memory device. Here, we propose a mechanism of switching based on an oxygen vacancy migration-driven change in the electronic properties of the transition-metal oxide film stimulated by set pulse voltages. We used density functional theory-based calculations to account for the effect of oxygen vacancies and their migration on the electronic properties of HfO2 and Ta/HfO2 systems, thereby providing a complete explanation of the RRAM™ switching mechanism. Furthermore, computational results on the activation energy barrier for oxygen vacancy migration were found to be consistent with the set and reset pulse voltage obtained from experiments. Understanding this mechanism will be beneficial to effectively realizing the materials design in these devices.

Recruitment of black and Latina women to a randomized controlled trial.

PubMed

Martin, Anika; Negron, Rennie; Balbierz, Amy; Bickell, Nina; Howell, Elizabeth A

2013-08-01

Minority women are often not adequately represented in randomized controlled trials, limiting the generalizability of research trial results. We implemented a recruitment strategy for a postpartum depression prevention trial that utilized patient feedback to identify and understand the recruitment barriers of black and Latina postpartum women. Feedback on patients' reasons for trial refusal informed adaptations to the recruitment process. We calculated weekly recruitment rates and analyzed qualitative and quantitative data from patient refusals. Of the 668 women who were approached and completed the consent process, 540 enrolled in the trial and 128 declined participation. Over 52-weeks of recruitment, refusal rates decreased from 40% to 19%. A taxonomy of eight reasons for refusal derived from patient responses identified barriers to recruitment and generated targeted revisions to the recruitment message. A recruitment strategy designed to incorporate and respond to patient feedback improved recruitment of Black and Latina women to a clinical trial.

Representation of high frequency Space Shuttle data by ARMA algorithms and random response spectra

NASA Technical Reports Server (NTRS)

Spanos, P. D.; Mushung, L. J.

1990-01-01

High frequency Space Shuttle lift-off data are treated by autoregressive (AR) and autoregressive-moving-average (ARMA) digital algorithms. These algorithms provide useful information on the spectral densities of the data. Further, they yield spectral models which lend themselves to incorporation to the concept of the random response spectrum. This concept yields a reasonably smooth power spectrum for the design of structural and mechanical systems when the available data bank is limited. Due to the non-stationarity of the lift-off event, the pertinent data are split into three slices. Each of the slices is associated with a rather distinguishable phase of the lift-off event, where stationarity can be expected. The presented results are rather preliminary in nature; it is aimed to call attention to the availability of the discussed digital algorithms and to the need to augment the Space Shuttle data bank as more flights are completed.

Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design

PubMed Central

2011-01-01

Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (<45 versus ≥45 years), presence of atrial septal aneurysm (ASA yes or no) and number of embolic events before randomization (one versus more than one event). Primary endpoints are death, nonfatal stroke and peripheral embolism. Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011). Trial Registration Trial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA PMID:21356042

Teen Online Problem Solving for Teens With Traumatic Brain Injury: Rationale, Methods, and Preliminary Feasibility of a Teen Only Intervention

PubMed Central

Wade, Shari L.; Narad, Megan E.; Kingery, Kathleen M.; Taylor, H. Gerry; Stancin, Terry; Kirkwood, Michael W.; Yeates, Keith O.

2017-01-01

Purpose/Objective To describe the Teen Online Problem Solving—Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving—Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11–18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Results Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). Conclusions/Implications TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. PMID:28836809

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

PubMed Central

Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

2015-01-01

Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

Review: Assessment of completeness of reporting in intervention studies using livestock: an example from pain mitigation interventions in neonatal piglets.

PubMed

O'Connor, A; Anthony, R; Bergamasco, L; Coetzee, J F; Dzikamunhenga, R S; Johnson, A K; Karriker, L A; Marchant-Forde, J N; Martineau, G P; Millman, S T; Pajor, E A; Rutherford, K; Sprague, M; Sutherland, M A; von Borell, E; Webb, S R

2016-04-01

Accurate and complete reporting of study methods, results and interpretation are essential components for any scientific process, allowing end-users to evaluate the internal and external validity of a study. When animals are used in research, excellence in reporting is expected as a matter of continued ethical acceptability of animal use in the sciences. Our primary objective was to assess completeness of reporting for a series of studies relevant to mitigation of pain in neonatal piglets undergoing routine management procedures. Our second objective was to illustrate how authors can report the items in the Reporting guidElines For randomized controLled trials for livEstoCk and food safety (REFLECT) statement using examples from the animal welfare science literature. A total of 52 studies from 40 articles were evaluated using a modified REFLECT statement. No single study reported all REFLECT checklist items. Seven studies reported specific objectives with testable hypotheses. Six studies identified primary or secondary outcomes. Randomization and blinding were considered to be partially reported in 21 and 18 studies, respectively. No studies reported the rationale for sample sizes. Several studies failed to report key design features such as units for measurement, means, standard deviations, standard errors for continuous outcomes or comparative characteristics for categorical outcomes expressed as either rates or proportions. In the discipline of animal welfare science, authors, reviewers and editors are encouraged to use available reporting guidelines to ensure that scientific methods and results are adequately described and free of misrepresentations and inaccuracies. Complete and accurate reporting increases the ability to apply the results of studies to the decision-making process and prevent wastage of financial and animal resources.

Teen online problem solving for teens with traumatic brain injury: Rationale, methods, and preliminary feasibility of a teen only intervention.

PubMed

Wade, Shari L; Narad, Megan E; Kingery, Kathleen M; Taylor, H Gerry; Stancin, Terry; Kirkwood, Michael W; Yeates, Keith O

2017-08-01

To describe the Teen Online Problem Solving-Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving-Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design: This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11-18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Impact of post-remission therapy in patients aged 65–70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria

PubMed Central

Itzykson, Raphael; Gardin, Claude; Pautas, Cécile; Thomas, Xavier; Turlure, Pascal; Raffoux, Emmanuel; Terré, Christine; Fenaux, Pierre; Castaigne, Sylvie; Dombret, Hervé; Boissel, Nicolas

2011-01-01

Background There is no standard post-remission therapy in older patients with acute myeloid leukemia. Design and Methods From 1999 to 2006, the Acute Leukemia French Association group ran two concurrent randomized trials with overlapping inclusion criteria for patients aged 65 to 70 with acute myeloid leukemia, with different post-remission strategies: two intensive courses in the 9801 trial, one intensive course or six outpatient courses in the 9803 trial. We analyzed the outcome of these patients per protocol and per post-remission therapy. Results Two hundred and eleven patients aged 65 to 70 years with de novo acute myeloid leukemia were enrolled in trial 9801 (n=76) or 9803 (n=135). The patients in the two trials had comparable white blood cell counts (P=0.3), cytogenetics (P=0.49), and complete remission rates (70% and 57%, respectively; P=0.17). Overall survival was identical in both trials (32% and 34% at 2 years, respectively; P=0.71). Overall survival after complete remission was identical in the 103 of 130 patients who received the planned post-remission courses (n=44 with two intensive courses, n=28 with one intensive course, n=31 with six outpatient courses; 41%, 55%, and 58% at 2 years, respectively; P=0.34). Even in patients with favorable or normal karyotype (n=97), overall survival from complete remission was not improved by more intensive post-remission therapy. Conclusions In patients aged 65 to 70 years with de novo acute myeloid leukemia in complete remission after standard intensive induction chemotherapy, there is no apparent benefit from intensive post-remission therapy. (ClinicalTrials.gov Identifiers: NCT00931138 and NCT00363025) PMID:21459791

Efficacy of educational video game versus traditional educational apps at improving physician decision making in trauma triage: randomized controlled trial

PubMed Central

Farris, Coreen; Fischhoff, Baruch; Rosengart, Matthew R; Angus, Derek C; Yealy, Donald M; Wallace, David J; Barnato, Amber E

2017-01-01

Abstract Objective To determine whether a behavioral intervention delivered through a video game can improve the appropriateness of trauma triage decisions in the emergency department of non-trauma centers. Design Randomized clinical trial. Setting Online intervention in national sample of emergency medicine physicians who make triage decisions at US hospitals. Participants 368 emergency medicine physicians primarily working at non-trauma centers. A random sample (n=200) of those with primary outcome data was reassessed at six months. Interventions Physicians were randomized in a 1:1 ratio to one hour of exposure to an adventure video game (Night Shift) or apps based on traditional didactic education (myATLS and Trauma Life Support MCQ Review), both on iPads. Night Shift was developed to recalibrate the process of using pattern recognition to recognize moderate-severe injuries (representativeness heuristics) through the use of stories to promote behavior change (narrative engagement). Physicians were randomized with a 2×2 factorial design to intervention (game v traditional education apps) and then to the experimental condition under which they completed the outcome assessment tool (low v high cognitive load). Blinding could not be maintained after allocation but group assignment was masked during the analysis phase. Main outcome measures Outcomes of a virtual simulation that included 10 cases; in four of these the patients had severe injuries. Participants completed the simulation within four weeks of their intervention. Decisions to admit, discharge, or transfer were measured. The proportion of patients under-triaged (patients with severe injuries not transferred to a trauma center) was calculated then (primary outcome) and again six months later, with a different set of cases (primary outcome of follow-up study). The secondary outcome was effect of cognitive load on under-triage. Results 149 (81%) physicians in the game arm and 148 (80%) in the traditional education arm completed the trial. Of these, 64/100 (64%) and 58/100 (58%), respectively, completed reassessment at six months. The mean age was 40 (SD 8.9), 283 (96%) were trained in emergency medicine, and 207 (70%) were ATLS (advanced trauma life support) certified. Physicians exposed to the game under-triaged fewer severely injured patients than those exposed to didactic education (316/596 (0.53) v 377/592 (0.64), estimated difference 0.11, 95% confidence interval 0.05 to 0.16; P<0.001). Cognitive load did not influence under-triage (161/308 (0.53) v 155/288 (0.54) in the game arm; 197/300 (0.66) v 180/292 (0.62) in the traditional educational apps arm; P=0.66). At six months, physicians exposed to the game remained less likely to under-triage patients (146/256 (0.57) v 172/232 (0.74), estimated difference 0.17, 0.09 to 0.25; P<0.001). No physician reported side effects. The sample might not reflect all emergency medicine physicians, and a small set of cases was used to assess performance. Conclusions Compared with apps based on traditional didactic education, exposure of physicians to a theoretically grounded video game improved triage decision making in a validated virtual simulation. Though the observed effect was large, the wide confidence intervals include the possibility of a small benefit, and the real world efficacy of this intervention remains uncertain. Trial registration clinicaltrials.gov; NCT02857348 (initial study)/NCT03138304 (follow-up). PMID:29233854

Orthopaedic resident preparedness for closed reduction and pinning of pediatric supracondylar fractures is improved by e-learning: a multisite randomized controlled study.

PubMed

Hearty, Thomas; Maizels, Max; Pring, Maya; Mazur, John; Liu, Raymond; Sarwark, John; Janicki, Joseph

2013-09-04

There is a need to provide more efficient surgical training methods for orthopaedic residents. E-learning could possibly increase resident surgical preparedness, confidence, and comfort for surgery. Using closed reduction and pinning of pediatric supracondylar humeral fractures as the index case, we hypothesized that e-learning could increase resident knowledge acquisition for case preparation in the operating room. An e-learning surgical training module was created on the Computer Enhanced Visual Learning platform. The module provides a detailed and focused road map of the procedure utilizing a multimedia format. A multisite prospective randomized controlled study design compared residents who used a textbook for case preparation (control group) with residents who used the same textbook plus completed the e-learning module (test group). All subjects completed a sixty-question test on the theory and methods of the case. After completion of the test, the control group then completed the module as well. All subjects were surveyed on their opinion regarding the effectiveness of the module after performing an actual surgical case. Twenty-eight subjects with no previous experience in this surgery were enrolled at four academic centers. Subjects were randomized into two equal groups. The test group scored significantly better (p < 0.001) and demonstrated competence on the test compared with the control group; the mean correct test score (and standard deviation) was 90.9% ± 6.8% for the test group and 73.5% ± 6.4% for the control group. All residents surveyed (n = 27) agreed that the module is a useful supplement to traditional methods for case preparation and twenty-two of twenty-seven residents agreed that it reduced their anxiety during the case and improved their attention to surgical detail. E-learning using the Computer Enhanced Visual Learning platform significantly improved preparedness, confidence, and comfort with percutaneous closed reduction and pinning of a pediatric supracondylar humeral fracture. We believe that adapting such methods into residency training programs will improve efficiency in surgical training.

Changing friend selection in middle school: A social network analysis of a randomized intervention study designed to prevent adolescent problem behavior

PubMed Central

DeLay, Dawn; Ha, Thao; Van Ryzin, Mark; Winter, Charlotte; Dishion, Thomas J.

2015-01-01

Adolescent friendships that promote problem behavior are often chosen in middle school. The current study examines the unintended impact of a randomized school based intervention on the selection of friends in middle school, as well as on observations of deviant talk with friends five years later. Participants included 998 middle school students (526 boys and 472 girls) recruited at the onset of middle school (age 11-12 years) from three public middle schools participating in the Family Check-up model intervention. The current study focuses only on the effects of the SHAPe curriculum—one level of the Family Check-up model—on friendship choices. Participants nominated friends and completed measures of deviant peer affiliation. Approximately half of the sample (n=500) was randomly assigned to the intervention and the other half (n=498) comprised the control group within each school. The results indicate that the SHAPe curriculum affected friend selection within School 1, but not within Schools 2 or 3. The effects of friend selection in School 1 translated into reductions in observed deviancy training five years later (age 16-17 years). By coupling longitudinal social network analysis with a randomized intervention study the current findings provide initial evidence that a randomized public middle school intervention can disrupt the formation of deviant peer groups and diminish levels of adolescent deviance five years later. PMID:26377235

Recruitment and retention of women in a large randomized control trial to reduce repeat preterm births: the Philadelphia Collaborative Preterm Prevention Project

PubMed Central

2010-01-01

Background Recruitment and retention of patients for randomized control trial (RCT) studies can provide formidable challenges, particularly with minority and underserved populations. Data are reported for the Philadelphia Collaborative Preterm Prevention Project (PCPPP), a large RCT targeting risk factors for repeat preterm births among women who previously delivered premature (< 35 weeks gestation) infants. Methods Design of the PCPPP incorporated strategies to maximize recruitment and retention. These included an advanced database system tracking follow-up status and assessment completion rates; cultural sensitivity training for staff; communication to the community and eligible women of the benefits of participation; financial incentives; assistance with transportation and supervised childcare services; and reminder calls for convenient, flexibly scheduled appointments. Analyses reported here: 1) compare recruitment projections to actual enrollment 2) explore recruitment bias; 3) validate the randomization process 4) document the extent to which contact was maintained and complete assessments achieved 5) determine if follow-up was conditioned upon socio-economic status, race/ethnicity, or other factors. Results Of eligible women approached, 1,126 (77.7%) agreed to participate fully. Of the 324 not agreeing, 118 (36.4%) completed a short survey. Consenting women were disproportionately from minority and low SES backgrounds: 71.5% consenting were African American, versus 38.8% not consenting. Consenting women were also more likely to report homelessness during their lifetime (14.6% vs. 0.87%) and to be unmarried at the time of delivery (81.6% versus 47.9%). First one-month postpartum assessment was completed for 83.5% (n = 472) of the intervention group (n = 565) and 76% (426) of the control group. Higher assessment completion rates were observed for the intervention group throughout the follow-up. Second, third, fourth and fifth postpartum assessments were 67.6% vs. 57.5%, 60.0% vs. 48.9%, 54.2% vs. 46.3% and 47.3% vs. 40.8%, for the intervention and control group women, respectively. There were no differences in follow-up rates according to race/ethnicity, SES or other factors. Greater retention of the intervention group may reflect the highly-valued nature of the medical and behavior services constituting the intervention arms of the Project. Conclusion Findings challenge beliefs that low income and minority women are averse to enrolling and continuing in clinical trials or community studies. PMID:20920265

Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

PubMed

Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

2011-10-01

Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial.

PubMed

Burbach, J P Maarten; Verkooijen, Helena M; Intven, Martijn; Kleijnen, Jean-Paul J E; Bosman, Mirjam E; Raaymakers, Bas W; van Grevenstein, Wilhelmina M U; Koopman, Miriam; Seravalli, Enrica; van Asselen, Bram; Reerink, Onne

2015-02-22

Treatment for locally advanced rectal cancer (LARC) consists of chemoradiation therapy (CRT) and surgery. Approximately 15% of patients show a pathological complete response (pCR). Increased pCR-rates can be achieved through dose escalation, thereby increasing the number patients eligible for organ-preservation to improve quality of life (QoL). A randomized comparison of 65 versus 50Gy with external-beam radiation alone has not yet been performed. This trial investigates pCR rate, clinical response, toxicity, QoL and (disease-free) survival in LARC patients treated with 65Gy (boost + chemoradiation) compared with 50Gy standard chemoradiation (sCRT). This study follows the 'cohort multiple randomized controlled trial' (cmRCT) design: rectal cancer patients are included in a prospective cohort that registers clinical baseline, follow-up, survival and QoL data. At enrollment, patients are asked consent to offer them experimental interventions in the future. Eligible patients-histologically confirmed LARC (T3NxM0 <1 mm from mesorectal fascia, T4NxM0 or TxN2M0) located ≤10 cm from the anorectal transition who provided consent for experimental intervention offers-form a subcohort (n = 120). From this subcohort, a random sample is offered the boost prior to sCRT (n = 60), which they may accept or refuse. Informed consent is signed only after acceptance of the boost. Non-selected patients in the subcohort (n = 60) undergo sCRT alone and are not notified that they participate in the control arm until the trial is completed. sCRT consists of 50Gy (25 × 2Gy) with concomitant capecitabine. The boost (without chemotherapy) is given prior to sCRT and consists of 15 Gy (5 × 3Gy) delivered to the gross tumor volume (GTV). The primary endpoint is pCR (TRG 1). Secondary endpoints include acute grade 3-4 toxicity, good pathologic response (TRG 1-2), clinical response, surgical complications, QoL and (disease-free) survival. Data is analyzed by intention to treat. The boost is delivered prior to sCRT so that GTV adjustment for tumor shrinkage during sCRT is not necessary. Small margins also aim to limit irradiation of healthy tissue. The cmRCT design provides opportunity to overcome common shortcomings of classic RCTs, such as slow recruitment, disappointment-bias in control arm patients and poor generalizability. The Netherlands Trials Register NL46051.041.13. Registered 22 August 2013. ClinicalTrials.gov NCT01951521 . Registered 18 September 2013.

The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults.

PubMed

Squiers, Linda; Brown, Derick; Parvanta, Sarah; Dolina, Suzanne; Kelly, Bridget; Dever, Jill; Southwell, Brian G; Sanders, Amy; Augustson, Erik

2016-06-27

Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study's operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute's SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were eligible to participate. Of the 15,462 who were eligible, 9486 passed the antifraud measures that were implemented; however, 3882 failed to verify their email addresses or cell phone numbers, leaving 5604 who were invited to complete the baseline survey. Of the 5604 who were invited, 4432 completed the baseline survey, but only 4027 were retained for analysis because 405 did not receive the intervention. Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected, it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study. Future research should explore ways to implement verification methods without risking the loss of so many potential participants. Clinical Trials.gov NCT01885052; https://clinicaltrials.gov/ct2/show/NCT01885052; (Archived by WebCite at http://www.webcitation.org/6iWzcmFdw).

The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults

PubMed Central

Brown, Derick; Parvanta, Sarah; Dolina, Suzanne; Kelly, Bridget; Dever, Jill; Southwell, Brian G; Sanders, Amy; Augustson, Erik

2016-01-01

Background Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study’s operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. Objective The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute’s SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. Methods Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. Results Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were eligible to participate. Of the 15,462 who were eligible, 9486 passed the antifraud measures that were implemented; however, 3882 failed to verify their email addresses or cell phone numbers, leaving 5604 who were invited to complete the baseline survey. Of the 5604 who were invited, 4432 completed the baseline survey, but only 4027 were retained for analysis because 405 did not receive the intervention. Conclusions Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected, it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study. Future research should explore ways to implement verification methods without risking the loss of so many potential participants. ClinicalTrial Clinical Trials.gov NCT01885052; https://clinicaltrials.gov/ct2/show/NCT01885052; (Archived by WebCite at http://www.webcitation.org/6iWzcmFdw) PMID:27349898

A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison

ERIC Educational Resources Information Center

Gordon, Michael S.; Kinlock, Timothy W.; Couvillion, Kathryn A.; Schwartz, Robert P.; O'Grady, Kevin

2012-01-01

The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly…

Examining the Missing Completely at Random Mechanism in Incomplete Data Sets: A Multiple Testing Approach

ERIC Educational Resources Information Center

Raykov, Tenko; Lichtenberg, Peter A.; Paulson, Daniel

2012-01-01

A multiple testing procedure for examining implications of the missing completely at random (MCAR) mechanism in incomplete data sets is discussed. The approach uses the false discovery rate concept and is concerned with testing group differences on a set of variables. The method can be used for ascertaining violations of MCAR and disproving this…

Quantum walk on a chimera graph

NASA Astrophysics Data System (ADS)

Xu, Shu; Sun, Xiangxiang; Wu, Jizhou; Zhang, Wei-Wei; Arshed, Nigum; Sanders, Barry C.

2018-05-01

We analyse a continuous-time quantum walk on a chimera graph, which is a graph of choice for designing quantum annealers, and we discover beautiful quantum walk features such as localization that starkly distinguishes classical from quantum behaviour. Motivated by technological thrusts, we study continuous-time quantum walk on enhanced variants of the chimera graph and on diminished chimera graph with a random removal of vertices. We explain the quantum walk by constructing a generating set for a suitable subgroup of graph isomorphisms and corresponding symmetry operators that commute with the quantum walk Hamiltonian; the Hamiltonian and these symmetry operators provide a complete set of labels for the spectrum and the stationary states. Our quantum walk characterization of the chimera graph and its variants yields valuable insights into graphs used for designing quantum-annealers.

Development of land based radar polarimeter processor system

NASA Technical Reports Server (NTRS)

Kronke, C. W.; Blanchard, A. J.

1983-01-01

The processing subsystem of a land based radar polarimeter was designed and constructed. This subsystem is labeled the remote data acquisition and distribution system (RDADS). The radar polarimeter, an experimental remote sensor, incorporates the RDADS to control all operations of the sensor. The RDADS uses industrial standard components including an 8-bit microprocessor based single board computer, analog input/output boards, a dynamic random access memory board, and power supplis. A high-speed digital electronics board was specially designed and constructed to control range-gating for the radar. A complete system of software programs was developed to operate the RDADS. The software uses a powerful real time, multi-tasking, executive package as an operating system. The hardware and software used in the RDADS are detailed. Future system improvements are recommended.

The Effectiveness of the Harm Reduction Group Therapy Based on Bandura's Self-Efficacy Theory on Risky Behaviors of Drug-Dependent Sex Worker Women.

PubMed

Rabani-Bavojdan, Marjan; Rabani-Bavojdan, Mozhgan; Rajabizadeh, Ghodratollah; Kaviani, Nahid; Bahramnejad, Ali; Ghaffari, Zohreh; Shafiei-Bafti, Mehdi

2017-07-01

The aim of this study was to investigate the effectiveness of the harm reduction group therapy based on Bandura's self-efficacy theory on risky behaviors of sex workers in Kerman, Iran. A quasi-experimental two-group design (a random selection with pre-test and post-test) was used. A risky behaviors questionnaire was used to collect. The sample was selected among sex workers referring to drop-in centers in Kerman. Subjects were allocated to two groups and were randomly classified into two experimental and control groups. The sample group consisted of 56 subjects. The experimental design was carried out during 12 sessions, and the post-test was performed one month and two weeks after the completion of the sessions. The results were analyzed statistically. By reducing harm based on Bandura's self-efficacy theory, the risky behaviors of the experimental group, including injection behavior, sexual behavior, violence, and damage to the skin, were significantly reduced in the pre-test compared to the post-test (P < 0.010). The harm reduction group therapy based on Bandura's self-efficacy theory can reduce the risky behaviors of sex workers.

Advantages and disadvantages of biodegradable platforms in drug eluting stents.

PubMed

Rodriguez-Granillo, Agustina; Rubilar, Bibiana; Rodriguez-Granillo, Gaston; Rodriguez, Alfredo E

2011-03-26

Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to bare-metal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place. Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

Design of a completely model free adaptive control in the presence of parametric, non-parametric uncertainties and random control signal delay.

PubMed

Tutsoy, Onder; Barkana, Duygun Erol; Tugal, Harun

2018-05-01

In this paper, an adaptive controller is developed for discrete time linear systems that takes into account parametric uncertainty, internal-external non-parametric random uncertainties, and time varying control signal delay. Additionally, the proposed adaptive control is designed in such a way that it is utterly model free. Even though these properties are studied separately in the literature, they are not taken into account all together in adaptive control literature. The Q-function is used to estimate long-term performance of the proposed adaptive controller. Control policy is generated based on the long-term predicted value, and this policy searches an optimal stabilizing control signal for uncertain and unstable systems. The derived control law does not require an initial stabilizing control assumption as in the ones in the recent literature. Learning error, control signal convergence, minimized Q-function, and instantaneous reward are analyzed to demonstrate the stability and effectiveness of the proposed adaptive controller in a simulation environment. Finally, key insights on parameters convergence of the learning and control signals are provided. Copyright © 2018 ISA. Published by Elsevier Ltd. All rights reserved.

Randomized trial of an uncertainty self-management telephone intervention for patients awaiting liver transplant.

PubMed

Bailey, Donald E; Hendrix, Cristina C; Steinhauser, Karen E; Stechuchak, Karen M; Porter, Laura S; Hudson, Julie; Olsen, Maren K; Muir, Andrew; Lowman, Sarah; DiMartini, Andrea; Salonen, Laurel Williams; Tulsky, James A

2017-03-01

We tested an uncertainty self-management telephone intervention (SMI) with patients awaiting liver transplant and their caregivers. Participants were recruited from four transplant centers and completed questionnaires at baseline, 10, and 12 weeks from baseline (generally two and four weeks after intervention delivery, respectively). Dyads were randomized to either SMI (n=56) or liver disease education (LDE; n=59), both of which involved six weekly telephone sessions. SMI participants were taught coping skills and uncertainty management strategies while LDE participants learned about liver function and how to stay healthy. Outcomes included illness uncertainty, uncertainty management, depression, anxiety, self-efficacy, and quality of life. General linear models were used to test for group differences. No differences were found between the SMI and LDE groups for study outcomes. This trial offers insight regarding design for future interventions that may allow greater flexibility in length of delivery beyond our study's 12-week timeframe. Our study was designed for the time constraints of today's clinical practice setting. This trial is a beginning point to address the unmet needs of these patients and their caregivers as they wait for transplants that could save their lives. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Design for cyclic loading endurance of composites

NASA Technical Reports Server (NTRS)

Shiao, Michael C.; Murthy, Pappu L. N.; Chamis, Christos C.; Liaw, Leslie D. G.

1993-01-01

The application of the computer code IPACS (Integrated Probabilistic Assessment of Composite Structures) to aircraft wing type structures is described. The code performs a complete probabilistic analysis for composites taking into account the uncertainties in geometry, boundary conditions, material properties, laminate lay-ups, and loads. Results of the analysis are presented in terms of cumulative distribution functions (CDF) and probability density function (PDF) of the fatigue life of a wing type composite structure under different hygrothermal environments subjected to the random pressure. The sensitivity of the fatigue life to a number of critical structural/material variables is also computed from the analysis.

Effective Web and Desktop Retrieval with Enhanced Semantic Spaces

NASA Astrophysics Data System (ADS)

Daoud, Amjad M.

We describe the design and implementation of the NETBOOK prototype system for collecting, structuring and efficiently creating semantic vectors for concepts, noun phrases, and documents from a corpus of free full text ebooks available on the World Wide Web. Automatic generation of concept maps from correlated index terms and extracted noun phrases are used to build a powerful conceptual index of individual pages. To ensure scalabilty of our system, dimension reduction is performed using Random Projection [13]. Furthermore, we present a complete evaluation of the relative effectiveness of the NETBOOK system versus the Google Desktop [8].

Evaluation of the Dogs, Physical Activity, and Walking (Dogs PAW) Intervention: A Randomized Controlled Trial.

PubMed

Richards, Elizabeth A; Ogata, Niwako; Cheng, Ching-Wei

2016-01-01

To facilitate physical activity (PA) adoption and maintenance, promotion of innovative population-level strategies that focus on incorporating moderate-intensity lifestyle PAs are needed. The purpose of this randomized controlled trial was to evaluate the Dogs, Physical Activity, and Walking intervention, a 3-month, social cognitive theory (SCT), e-mail-based PA intervention. In a longitudinal, repeated-measures design, 49 dog owners were randomly assigned to a control (n = 25) or intervention group (n = 24). The intervention group received e-mail messages (twice weekly for 4 weeks and weekly for 8 weeks) designed to influence SCT constructs of self-efficacy, self-regulation, outcome expectations and expectancies, and social support. At baseline and every 3 months through 1 year, participants completed self-reported questionnaires of individual, interpersonal, and PA variables. Linear mixed models were used to assess for significant differences in weekly minutes of dog walking and theoretical constructs between groups (intervention and control) across time. To test self-efficacy as a mediator of social support for dog walking, tests for mediation were conducted using the bootstrapping technique. With the exception of Month 9, participants in the intervention group accumulated significantly more weekly minutes of dog walking than the control group. On average, the intervention group accumulated 58.4 more minutes (SD = 18.1) of weekly dog walking than the control group (p < .05). Self-efficacy partially mediated the effect of social support variables on dog walking. Results indicate that a simple SCT-based e-mail intervention is effective in increasing and maintaining an increase in dog walking among dog owners at 12-month follow-up. In light of these findings, it may be advantageous to design dog walking interventions that focus on increasing self-efficacy for dog walking by fostering social support.

Design and rationale for the Effects of Ticagrelor and Clopidogrel in Patients with Peripheral Artery Disease (EUCLID) trial.

PubMed

Berger, Jeffrey S; Katona, Brian G; Jones, W Schuyler; Patel, Manesh R; Norgren, Lars; Baumgartner, Iris; Blomster, Juuso; Mahaffey, Kenneth W; Held, Peter; Millegård, Marcus; Heizer, Gretchen; Reist, Craig; Fowkes, F Gerry; Hiatt, William R

2016-05-01

Despite overwhelming data demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data in peripheral artery disease (PAD) are less compelling. Aspirin has modest evidence supporting a reduction in cardiovascular events in patients with PAD, whereas clopidogrel monotherapy may be more effective in PAD. Ticagrelor, a potent, reversibly binding P2Y12 receptor antagonist, is beneficial in patients with acute coronary syndrome and prior myocardial infarction. The EUCLID trial is designed to address the need for effective antiplatelet therapy in PAD to decrease the risk of cardiovascular events. EUCLID is a randomized, double-blind, parallel-group, multinational clinical trial designed to evaluate the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events in subjects with symptomatic PAD. Subjects with established PAD will be randomized in a 1:1 fashion to ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. The primary end point is a composite of cardiovascular death, myocardial infarction, or ischemic stroke. Other end points address limb events including acute leg ischemia, need for revascularization, disease progression by ankle-brachial index, and quality of life. The primary safety objective is Thrombolysis in Myocardial Infarction-defined major bleeding. Recruitment began in December 2012 and was completed in March 2014; 13,887 patients were randomized. The trial will continue until at least 1,364 adjudicated primary end points occur. The EUCLID study is investigating whether treatment with ticagrelor versus clopidogrel, given as antiplatelet monotherapy, will reduce the incidence of cardiovascular and limb-specific events in patients with symptomatic PAD. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

PubMed

Fries, James F; Krishnan, Eswar

2004-01-01

The concept of 'equipoise', or the 'uncertainty principle', has been represented as a central ethical principle, and holds that a subject may be enrolled in a randomized controlled trial (RCT) only if there is true uncertainty about which of the trial arms is most likely to benefit the patient. We sought to estimate the frequency with which equipoise conditions were met in industry-sponsored RCTs in rheumatology, to explore the reasons for any deviations from equipoise, to examine the concept of 'design bias', and to consider alternative ethical formulations that might improve subject safety and autonomy. We studied abstracts accepted for the 2001 American College of Rheumatology meetings that reported RCTs, acknowledged industry sponsorship, and had clinical end-points (n = 45), and examined the proportion of studies that favored the registration or marketing of the sponsor's drug. In every trial (45/45) results were favorable to the sponsor, indicating that results could have been predicted in advance solely by knowledge of sponsorship (P < 0.0001). Equipoise clearly was being systematically violated. Publication bias appeared to be an incomplete explanation for this dramatic result; this bias occurs after a study is completed. Rather, we hypothesize that 'design bias', in which extensive preliminary data are used to design studies with a high likelihood of being positive, is the major cause of the asymmetric results. Design 'bias' occurs before the trial is begun and is inconsistent with the equipoise principle. However, design bias increases scientific efficiency, decreases drug development costs, and limits the number of subjects required, probably reducing aggregate risks to participants. Conceptual and ethical issues were found with the equipoise principle, which encourages performance of negative studies; ignores patient values, patient autonomy, and social benefits; is applied at a conceptually inappropriate decision point (after randomization rather than before); and is in conflict with the Belmont, Nuremberg, and other sets of ethical principles, as well as with US Food and Drug Administration procedures. We propose a principle of 'positive expected outcomes', which informs the assessment that a trial is ethical, together with a restatement of the priority of personal autonomy.

What's in a name? The challenge of describing interventions in systematic reviews: analysis of a random sample of reviews of non-pharmacological stroke interventions

PubMed Central

Hoffmann, Tammy C; Walker, Marion F; Langhorne, Peter; Eames, Sally; Thomas, Emma; Glasziou, Paul

2015-01-01

Objective To assess, in a sample of systematic reviews of non-pharmacological interventions, the completeness of intervention reporting, identify the most frequently missing elements, and assess review authors’ use of and beliefs about providing intervention information. Design Analysis of a random sample of systematic reviews of non-pharmacological stroke interventions; online survey of review authors. Data sources and study selection The Cochrane Library and PubMed were searched for potentially eligible systematic reviews and a random sample of these assessed for eligibility until 60 (30 Cochrane, 30 non-Cochrane) eligible reviews were identified. Data collection In each review, the completeness of the intervention description in each eligible trial (n=568) was assessed by 2 independent raters using the Template for Intervention Description and Replication (TIDieR) checklist. All review authors (n=46) were invited to complete a survey. Results Most reviews were missing intervention information for the majority of items. The most incompletely described items were: modifications, fidelity, materials, procedure and tailoring (missing from all interventions in 97%, 90%, 88%, 83% and 83% of reviews, respectively). Items that scored better, but were still incomplete for the majority of reviews, were: ‘when and how much’ (in 31% of reviews, adequate for all trials; in 57% of reviews, adequate for some trials); intervention mode (in 22% of reviews, adequate for all trials; in 38%, adequate for some trials); and location (in 19% of reviews, adequate for all trials). Of the 33 (71%) authors who responded, 58% reported having further intervention information but not including it, and 70% tried to obtain information. Conclusions Most focus on intervention reporting has been directed at trials. Poor intervention reporting in stroke systematic reviews is prevalent, compounded by poor trial reporting. Without adequate intervention descriptions, the conduct, usability and interpretation of reviews are restricted and therefore, require action by trialists, systematic reviewers, peer reviewers and editors. PMID:26576811

Circumventing the “Ick” Factor: A Randomized Trial of the Effects of Omitting Affective Attitudes Questions to Increase Intention to Become an Organ Donor

PubMed Central

Doherty, Sally; Dolan, Elizabeth; Flynn, Jennifer; O’Carroll, Ronan E.; Doyle, Frank

2017-01-01

Objectives: Including or excluding certain questions about organ donation may influence peoples’ intention to donate. We investigated the effect of omitting certain affective attitudinal items on potential donors’ intention and behavior for donation. Design: A cross-sectional survey with a subgroup nested randomized trial. Methods: A total of 578 members of the public in four shopping centers were surveyed on their attitudes to organ donation. Non-donors (n = 349) were randomly assigned to one of three groups: Group 1 completed items on affective and cognitive attitudes, anticipated regret, intention, subjective norm and perceived behavioral control. Group 2 completed all items above but excluded affective attitudes. Group 3 completed all items but omitted negatively worded affective attitudes. The primary outcome was intention to donate, taking a donor card after the interview was a secondary behavioral outcome, and both were predicted using linear and logistic regression with group 1 as the reference. Results: Mean (SD) 1–7 intention scores for groups 1, 2 and 3 were, respectively: 4.43 (SD 1.89), 4.95 (SD 1.64) and 4.88 (SD 1.81), with group 2 significantly higher than group 1 (β = 0.518, 95% confidence interval [CI] 0.18 to 0.86).At the end of the interview, people in group 2 (66.7%; OR = 1.40, 95% CI 0.94 to 2.07, p = 0.096) but not those in group 3 (61.7%; OR = 1.10, 95% CI 0.69 to 1.75, p = 0.685), were marginally more likely to accept a donor card from the interviewer than people in group 1 (59.7%). Conclusion: Omitting affective attitudinal items results in higher intention to donate organs and marginally higher rates of acceptance of donor cards, which has important implications for future organ donation public health campaigns. PMID:28894429

Knowledge of quality performance measures associated with endoscopy among gastroenterology trainees and the impact of a web-based intervention

PubMed Central

Thompson, Jennifer S.; Lebwohl, Benjamin; Syngal, Sapna; Kastrinos, Fay

2013-01-01

Background Knowledge of quality measures in endoscopy among trainees is unknown. Objective To assess knowledge of endoscopy-related quality indicators among U.S. trainees and determine whether it improves with a Web-based intervention. Design Randomized, controlled study. Setting Multicenter. Participants This study involved trainees identified from the American Society for Gastrointestinal Endoscopy membership database. Intervention Participants were invited to complete an 18-question online test. Respondents were randomized to receive a Web-based tutorial (intervention) or not. The test was readministered 6 weeks after randomization to determine the intervention’s impact. Main Outcome Measurements Baseline knowledge of endoscopy-related quality indicators and impact of the tutorial. Results A total of 347 of 1220 trainees (28%) completed the test; the mean percentage of correct responses was 55%. For screening colonoscopy, 44% knew the adenoma detection rate benchmark, 42% identified the cecal intubation rate goal, and 74% knew the recommended minimum withdrawal time. A total of 208 of 347 trainees (59%) completed the second test; baseline scores were similar for the tutorial (n = 106) and no tutorial (n = 102) groups (56.4% vs 56.9%, respectively). Scores improved after intervention for the tutorial group (65%, P = .003) but remained unchanged in the no tutorial group. On multivariate analysis, each additional year in training (odds ratio [OR] 2.3; 95% confidence interval [CI], 1.5–3.4), training at an academic institution (OR 2.6; 95% CI, 1.1–6.3), and receiving the tutorial (OR 3.2; 95% CI, 1.7–5.9) were associated with scores in the upper tertile. Limitations Low response rate. Conclusion Knowledge of endoscopy-related quality performance measures is low among trainees but can improve with a Web-based tutorial. Gastroenterology training programs may need to incorporate a formal didactic curriculum to supplement practice-based learning of quality standards in endoscopy. (Gastrointest Endosc 2012;76:100–6.) PMID:22421498

Happy@Work: protocol for a web-based randomized controlled trial to improve mental well-being among an Asian working population

PubMed Central

2014-01-01

Background Mental health issues pose a serious concern in the workplace for the huge productivity loss and financial burden associated with it. Unlike the traditional ‘fixing-what-is-wrong’ approach, positive psychology offers a less-stigmatized way to promote mental health. Psychological capital, a concept originated from positive psychology, has been proven effective in improving mental well-being and work performance. However, little evidence exists for its implementation among Asian working population or its cost-benefit for organizations adopting such promotion strategy. The current study is designed to assess the protective effects of a web-based psychology capital intervention among Hong Kong working population on individuals’ mental health and work performance, as well as organizations’ return-on-investment. Methods/Design A two-arm randomized controlled trial design will be adopted. Eligible working adults will be randomly allocated to either the intervention group or the waiting-list control group, with 177 participants in each arm. The intervention, which consists of four web-based training sessions, each targeting one of the psychological capital components (hope, efficacy, optimism and resilience), will be implemented over a 4-week period. On-line surveys will assess the participants in each group at baseline, intervention completion, 1 and 3 months after the completion. The primary outcome is individuals’ psychological capital level; secondary outcomes include individuals’ well-being, depressive symptoms, work engagement and productivity. Return-on-investment will be calculated from the employers’ perspective based on productivity gain, savings in medical expenditure, as well as operation and time costs. Analysis will follow the intention-to-treat principle. Discussion This is the first experimental study that explores the applicability of psychological capital development among Asian population. Through investigating changes in individuals’ work productivity from absenteeism and presenteeism, this will be one of the few studies that quantify productivity gains from any type of mental health promotion. By demonstrating effectiveness in improving mental well-being and a positive return-on-investment rate, the study may help convince more uptake of similar positive psychology interventions at workplace in Asia and elsewhere. Trail Registration Number (assigned by Centre for Clinical Trials, Clinical Trials Registry, The Chinese University of Hong Kong): CUHK_CCT00396. Registration Date: 2014/02/13 PMID:24997007

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

PubMed Central

DeWalt, Darren A; Broucksou, Kimberly A; Hawk, Victoria; Baker, David W; Schillinger, Dean; Ruo, Bernice; Bibbins-Domingo, Kirsten; Holmes, Mark; Weinberger, Morris; Macabasco-O'Connell, Aurelia; Pignone, Michael

2009-01-01

Background Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. Discussion Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. Trial Registration ClinicalTrials.gov NCT00378950 PMID:19519904

Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized controlled trial

PubMed Central

Michopoulos, Vasiliki; Mancini, Fulvia; Loucks, Tammy L.; Berga, Sarah L.

2013-01-01

Objective To determine whether cognitive behavior therapy (CBT), which we previously showed restored ovarian function in women with functional hypothalamic amenorrhea (FHA), also ameliorated hypercortisolemia and improved other neuroendocrine and metabolic concomitants of in FHA. Design Randomized controlled trial. Intervention CBT vs. observation. Setting Clinical research center at an academic medical university. Patient(s) Seventeen women with FHA were randomized either to CBT or observation. Main Outcome Measure(s) Circulatory concentrations of cortisol, leptin, TSH, total and free thyronine (T3), and total and free thyroxine (T4) before and immediately after completion of CBT or observation. Each woman served as her own control. Results CBT but not observation reduced cortisol levels in women with FHA. There were no changes in cortisol, leptin, TSH, T3, or T4 levels in women randomized to observation. Women treated with CBT showed increased levels of leptin and TSH, while levels of T3 and T4 remained unchanged. Conclusions CBT ameliorated hypercortisolism and improved neuroendocrine and metabolic concomitants of FHA while observation did not. We conclude that a cognitive, nonpharmacological approach aimed at alleviating problematic attitudes not only restored ovarian activity but also improved neuroendocrine and metabolic function in women with FHA. PMID:23507474

Decentring and distraction reduce overgeneral autobiographical memory in depression.

PubMed

Watkins, E; Teasdale, J D; Williams, R M

2000-07-01

Increased recall of categorical autobiographical memories is a phenomenon unique to depression and post-traumatic stress disorder, and is associated with a poor prognosis for depression. Although the elevated recall of categorical memories does not change on remission from depression, recent findings suggest that overgeneral memory may be reduced by cognitive interventions and maintained by rumination. This study tested whether cognitive manipulations could influence the recall of categorical memories in dysphoric participants. Forty-eight dysphoric and depressed participants were randomly allocated to rumination or distraction conditions. Before and after the manipulation, participants completed the Autobiographical Memory Test, a standard measure of overgeneral memory. Participants were then randomized to either a 'decentring' question (Socratic questions designed to facilitate viewing moods within a wider perspective) or a control question condition, before completing the Autobiographical Memory Test again. Distraction produced significantly greater decreases in the proportion of memories retrieved that were categorical than rumination. Decentring questions produced significantly greater decreases in the proportion of memories retrieved that were categorical than control questions, with this effect independent of the prior manipulation. Elevated categorical memory in depression is more modifiable than has been previously assumed; it may reflect the dynamic maintenance of a cognitive style that can be interrupted by brief cognitive interventions.

School factors and smoking prevalence among high school students in Japan.

PubMed

Osaki, Y; Minowa, M

1996-10-01

The purpose of this study was to analyze the relationship between student smoking prevalence by school and school factors. Junior and senior high schools were selected from throughout Japan using a simple random sampling. One hundred junior high schools and 50 senior high schools were randomly selected. Of these 70 junior high schools (70%) and 33 senior high schools (66%) responded to this survey. Self-administered anonymous questionnaires were completed by all enrolled students in each school. The principal of each school completed a school questionnaire about school factors. The smoking rate of male teachers was significantly related to the student smoking rate in junior high schools. This factor was still associated with the student smoking rate after adjusting for family smoking status. Surprisingly, the smoking rates for junior high school boys in schools with a school policy against teachers smoking were higher than those of schools without one. The dropout rate and the proportion of students who went on to college were significantly related to the smoking rates among senior high school students of both sexes. The regular-smoker rate of boys in schools with health education on smoking was more likely to be low. It is important to take account of school factors in designing smoking control programs for junior and senior high schools.

Design and use of a quantitative scale for measuring presyncope.

PubMed

Sheldon, Robert S; Amuah, Joseph E; Connolly, Stuart J; Rose, Sarah; Morillo, Carlos A; Talajic, Mario; Kus, Teresa; Fouad-Tarazi, Fetnat; Klingenheben, Thomas; Krahn, Andrew D; Sheldon, Aaron; Koshman, Mary-Lou; Ritchie, Debbie

2009-08-01

Vasovagal syncope is common and distressing. One important symptom is presyncope, but there are no clinimetric measures of this. We developed the Calgary Presyncope Form (CPF) and used it to test whether metoprolol reduces presyncope in a randomized trial. The CPF captures the frequency, duration, and severity of presyncope. We administered it to participants in the Prevention of Syncope Trial (POST), a randomized clinical trial that tested the hypothesis that metoprolol reduces syncope and presyncope in adult patients with vasovagal syncope. The CPF was completed by 44 patients on metoprolol and 39 patients on placebo, of a total of 208 subjects. Completion of the CPF for each of the threedimensions was 84-87% in the 83 respondents. Results were centrally distributed in duration and severity dimensions, but not in frequency. Patients had a median of 1.2 presyncopal spells per day, with a median moderate severity, lasting a median 10 minutes. The 3 scales were statistically independent of each other. These results were independent of subject age, and results in all 3 dimensions were stable over the observation period. There was no significant difference between patients on metoprolol and placebo in any dimension. The 3-dimensional CPF is simple, easy to use, stable over time, measures 3 independent variables, and documents that metoprolol does not reduce presyncope.

Construction of random sheared fosmid library from Chinese cabbage and its use for Brassica rapa genome sequencing project.

PubMed

Park, Tae-Ho; Park, Beom-Seok; Kim, Jin-A; Hong, Joon Ki; Jin, Mina; Seol, Young-Joo; Mun, Jeong-Hwan

2011-01-01

As a part of the Multinational Genome Sequencing Project of Brassica rapa, linkage group R9 and R3 were sequenced using a bacterial artificial chromosome (BAC) by BAC strategy. The current physical contigs are expected to cover approximately 90% euchromatins of both chromosomes. As the project progresses, BAC selection for sequence extension becomes more limited because BAC libraries are restriction enzyme-specific. To support the project, a random sheared fosmid library was constructed. The library consists of 97536 clones with average insert size of approximately 40 kb corresponding to seven genome equivalents, assuming a Chinese cabbage genome size of 550 Mb. The library was screened with primers designed at the end of sequences of nine points of scaffold gaps where BAC clones cannot be selected to extend the physical contigs. The selected positive clones were end-sequenced to check the overlap between the fosmid clones and the adjacent BAC clones. Nine fosmid clones were selected and fully sequenced. The sequences revealed two completed gap filling and seven sequence extensions, which can be used for further selection of BAC clones confirming that the fosmid library will facilitate the sequence completion of B. rapa. Copyright © 2011. Published by Elsevier Ltd.

The role of psychological flexibility in a self-help acceptance and commitment therapy intervention for psychological distress in a randomized controlled trial.

PubMed

Fledderus, Martine; Bohlmeijer, Ernst T; Fox, Jean-Paul; Schreurs, Karlein M G; Spinhoven, Philip

2013-03-01

This study examined the role of psychological flexibility, as a risk factor and as a process of change, in a self-help Acceptance and Commitment Therapy (ACT) intervention for adults with mild to moderate depression and anxiety. Participants were randomized to the self-help programme with e-mail support (n=250), or to a waiting list control group (n=126). All participants completed measures before and after the intervention to assess depression, anxiety and psychological flexibility. Participants in the experimental condition also completed these measures during the intervention (after three and six weeks) and at a three-month follow-up. With multilevel modelling, it was shown that the effects of the intervention on psychological distress were stronger for participants with higher levels of psychological flexibility. Furthermore, our study showed that improved psychological flexibility mediated the effects of the ACT intervention. With a cross-lagged panel design, it was shown that especially improvements in psychological flexibility in the last three sessions of the intervention were important for further reductions in anxiety. To conclude, our study showed the importance of targeting psychological flexibility during an ACT intervention for a reduction in depressive and anxiety symptoms. Copyright © 2012 Elsevier Ltd. All rights reserved.

Health Literacy Assessment of the STOFHLA: Paper versus electronic administration continuation study.

PubMed

Chesser, Amy K; Keene Woods, Nikki; Wipperman, Jennifer; Wilson, Rachel; Dong, Frank

2014-02-01

Low health literacy is associated with poor health outcomes. Research is needed to understand the mechanisms and pathways of its effects. Computer-based assessment tools may improve efficiency and cost-effectiveness of health literacy research. The objective of this preliminary study was to assess if administration of the Short Test of Functional Health Literacy in Adults (STOFHLA) through a computer-based medium was comparable to the paper-based test in terms of accuracy and time to completion. A randomized, crossover design was used to compare computer versus paper format of the STOFHLA at a Midwestern family medicine residency program. Eighty participants were initially randomized to either computer (n = 42) or paper (n = 38) format of the STOFHLA. After a 30-day washout period, participants returned to complete the other version of the STOFHLA. Data analysis revealed no significant difference between paper- and computer-based surveys (p = .9401; N = 57). The majority of participants showed "adequate" health literacy via paper- and computer-based surveys (100% and 97% of participants, respectively). Electronic administration of STOFHLA results were equivalent to the paper administration results for evaluation of adult health literacy. Future investigations should focus on expanded populations in multiple health care settings and validation of other health literacy screening tools in a clinical setting.

Teen CHAT: Development and utilization of a web-based intervention to improve physician communication with adolescents about healthy weight.

PubMed

Bravender, Terrill; Tulsky, James A; Farrell, David; Alexander, Stewart C; Østbye, Truls; Lyna, Pauline; Dolor, Rowena J; Coffman, Cynthia J; Bilheimer, Alicia; Lin, Pao-Hwa; Pollak, Kathryn I

2013-12-01

To describe the theoretical basis, use, and satisfaction with Teen CHAT, an online educational intervention designed to improve physician-adolescent communication about healthy weight. Routine health maintenance encounters between pediatricians and family practitioners and their overweight adolescent patients were audio recorded, and content was coded to summarize adherence with motivational interviewing techniques. An online educational intervention was developed using constructs from social cognitive theory and using personalized audio recordings. Physicians were randomized to the online intervention or not, and completed post-intervention surveys. Forty-six physicians were recruited, and 22 physicians were randomized to view the intervention website. The educational intervention took an average of 54min to complete, and most physicians thought it was useful, that they would use newly acquired skills with their patients, and would recommend it to others. Fewer physicians thought it helped them address confidentiality issues with their adolescent patients. The Teen CHAT online intervention shows potential for enhancing physician motivational interviewing skills in an acceptable and time-efficient manner. If found to be effective in enhancing motivational interviewing skills and changing adolescent weight-related behaviors, wide dissemination will be feasible and indicated. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Implementing collaborative care for depression treatment in primary care: A cluster randomized evaluation of a quality improvement practice redesign

PubMed Central

2011-01-01

Background Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness. Methods The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM. For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months. Results Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low predilection to adopt CCM (74% versus 48%%, p = 0.003). Conclusions Depression CCM designed and implemented by primary care practices using EBQI improved antidepressant initiation. Combining QI methods with a randomized evaluation proved challenging, but enabled new insights into the process of translating research-based CCM into practice. Future research on the effects of PCC attitudes and skills on CCM results, as well as on enhancing the link between improved antidepressant use and symptom outcomes, is needed. Trial Registration ClinicalTrials.gov: NCT00105820 PMID:22032247

Capacity-building and clinical competence in infectious disease in Uganda: a mixed-design study with pre/post and cluster-randomized trial components.

PubMed

Weaver, Marcia R; Crozier, Ian; Eleku, Simon; Makanga, Gyaviira; Mpanga Sebuyira, Lydia; Nyakake, Janepher; Thompson, MaryLou; Willis, Kelly

2012-01-01

Best practices for training mid-level practitioners (MLPs) to improve global health-services are not well-characterized. Two hypotheses were: 1) Integrated Management of Infectious Disease (IMID) training would improve clinical competence as tested with a single arm, pre-post design, and 2) on-site support (OSS) would yield additional improvements as tested with a cluster-randomized trial. Thirty-six Ugandan health facilities (randomized 1∶1 to parallel OSS and control arms) enrolled two MLPs each. All MLPs participated in IMID (3-week core course, two 1-week boost sessions, distance learning). After the 3-week course, OSS-arm trainees participated in monthly OSS. Twelve written case scenarios tested clinical competencies in HIV/AIDS, tuberculosis, malaria, and other infectious diseases. Each participant completed different randomly-assigned blocks of four scenarios before IMID (t0), after 3-week course (t1), and after second boost course (t2, 24 weeks after t1). Scoring guides were harmonized with IMID content and Ugandan national policy. Score analyses used a linear mixed-effects model. The primary outcome measure was longitudinal change in scenario scores. Scores were available for 856 scenarios. Mean correct scores at t0, t1, and t2 were 39.3%, 49.1%, and 49.6%, respectively. Mean score increases (95% CI, p-value) for t0-t1 (pre-post period) and t1-t2 (parallel-arm period) were 12.1 ((9.6, 14.6), p<0.001) and -0.6 ((-3.1, +1.9), p = 0.647) percent for OSS arm and 7.5 ((5.0, 10.0), p<0.001) and 1.6 ((-1.0, +4.1), p = 0.225) for control arm. The estimated mean difference in t1 to t2 score change, comparing arm A (participated in OSS) vs. arm B was -2.2 ((-5.8, +1.4), p = 0.237). From t0-t2, mean scores increased for all 12 scenarios. Clinical competence increased significantly after a 3-week core course; improvement persisted for 24 weeks. No additional impact of OSS was observed. Data on clinical practice, facility-level performance and health outcomes will complete assessment of overall impact of IMID and OSS. ClinicalTrials.gov NCT01190540.

A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners.

PubMed

Milbury, Kathrin; Tsao, Anne S; Liao, Zhongxing; Owns, April; Engle, Rosalinda; Gonzalez, Edrea A; Bruera, Eduardo; Cohen, Lorenzo

2018-01-01

Given the generally incurable nature of metastatic non-small cell lung cancer (mNSCLC), patients and their romantic partners are at risk for existential/spiritual distress. Although a handful of dyadic psychosocial interventions for lung cancer patients and their caregivers exist, none of them target spiritual well-being. Informed by the mindfulness-based intervention literature and our pilot work in couples affected by lung cancer, we developed a brief couple-based mind-body (CBMB) intervention. The primary aim of this research protocol is to determine the feasibility of implementing the CBMB intervention versus an active control (AC) or wait list control (WLC) group in patients with mNSCLC and their partners using a randomized controlled trial design. Seventy-five patients with mNSCLC receiving treatment and their partners are randomized to the CBMB intervention, an AC or a WLC group. Those in the CBMB intervention and AC groups receive four intervention sessions of 60 min each over 4 weeks and complete weekly homework assignments. The first session is delivered in person, and the remaining sessions are delivered via videoconference. The dyads in the AC group discuss cancer-related and personal growth concerns with the interventionist but are not taught coping skills. Patients and partners in all groups complete baseline assessments of quality of life (QOL) prior to randomization. Follow-up assessments are performed 4 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 30% of eligible couples consent, ≥ 70% of enrolled couples are retained, and ≥ 50% of all CBMB and AC sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., spiritual well-being and psychological distress) and explore potential intervention mediators (i.e., compassion, communication, mindfulness, and closeness) to inform a larger, future trial. This trial will provide important information regarding the feasibility of a behavioral intervention in a vulnerable yet understudied population using videoconferencing and descriptive data regarding spiritual well-being and other indices of QOL in both mNSCLC patients and their partners. ClinicalTrials.gov NCT02596490.

V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial

PubMed Central

2013-01-01

Background Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk. Methods/Design Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson’s disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function. Discussion This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit. Trial Registration (NIH)–NCT01732653 PMID:23388087

Effect of Vitamin D Supplementation on Breast Cancer Biomarkers: CALGB 70806 (Alliance) Study Design and Baseline Data

PubMed Central

Apoe, Ogheneruona; Jung, Sin-Ho; Liu, Heshan; Seisler, Drew K; Charlamb, Jayne; Zekan, Patricia; Wang, Lili X.; Unzeitig, Gary W.; Garber, Judy; Marshall, James; Wood, Marie

2017-01-01

One in eight women will develop breast cancer over their lifetime with 230,000 women diagnosed in 2015. For this reason, breast cancer prevention efforts are essential. Vitamin D, with anticancer properties, may have a role in prevention of some cancers, including breast cancer. This report discusses the rationale, study protocol, and baseline data for a clinical trial of vitamin D and its effects on breast cancer biomarkers. This study was a randomized controlled trial designed to evaluate the effect of a fixed dose of vitamin D on specfic breast cancer biomarkers. Study participants were randomized to take either vitamin D or placebo for a period of 1 year. All participants had mammograms and blood drawn for serum biomarkers. A subset of participants underwent random periareolar fine needle aspiration to draw tissue for biomarkers. From January 2011 to December 2013, 300 premenopausal women, aged 59 or younger, were recruited from 41 institutions across the United States. A total of 102 women underwent random periareolar fine needle aspiration. The last subject completed the trial in January 2015. Baseline vitamin D levels for all participants ranged from 4–72 ng/mL, with 62% of participants being vitamin D deficient at enrollment (≥30 ng/mL or ≥75 nmo-l/L). The mean body mass index was 27.0 kg/m2 (range 15.1–53.6 kg/m2). 14% and 11.7% of participants were Hispanic or African American, respectively. Accrual and enrollment of participants is feasible for this type of multi-center prevention trial, and it can readily be carried out in a cooperative group setting. PMID:29081880

Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

PubMed

Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

2014-11-01

Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. Copyright © 2014 Elsevier Inc. All rights reserved.

Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: a randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children.

PubMed

Flores, Glenn; Walker, Candy; Lin, Hua; Lee, Michael; Fierro, Marco; Henry, Monica; Massey, Kenneth; Portillo, Alberto

2015-01-01

Six million US children have no health insurance, and substantial racial/ethnic disparities exist. The design, methods, and baseline characteristics are described for Kids' Health Insurance by Educating Lots of Parents (Kids' HELP), the first randomized, clinical trial of the effectiveness of Parent Mentors (PMs) in insuring uninsured minority children. Latino and African-American children eligible for but not enrolled in Medicaid/CHIP were randomized to PMs, or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents with ≥1 Medicaid/CHIP-covered children. PMs received two days of training, and provide intervention families with information on Medicaid/CHIP eligibility, assistance with application submission, and help maintaining coverage. Primary outcomes include obtaining health insurance, time interval to obtain coverage, and parental satisfaction. A blinded assessor contacts subjects monthly for one year to monitor outcomes. Of 49,361 candidates screened, 329 fulfilled eligibility criteria and were randomized. The mean age is seven years for children and 32 years for caregivers; 2/3 are Latino, 1/3 are African-American, and the mean annual family income is $21,857. Half of caregivers were unaware that their uninsured child is Medicaid/CHIP eligible, and 95% of uninsured children had prior insurance. Fifteen PMs completed two-day training sessions. All PMs are female and minority, 60% are unemployed, and the mean annual family income is $20,913. Post-PM-training, overall knowledge/skills test scores significantly increased, and 100% reported being very satisfied/satisfied with the training. Kids' HELP successfully reached target populations, met participant enrollment goals, and recruited and trained PMs. Copyright © 2014 Elsevier Inc. All rights reserved.

Results of Mujeres Felices por ser Saludables: a dietary/breast health randomized clinical trial for Latino women.

PubMed

Fitzgibbon, Marian L; Gapstur, Susan M; Knight, Sara J

2004-10-01

Data are limited on the efficacy of health-focused interventions for young, low-acculturated Latino women. Because breast cancer is the most commonly diagnosed cancer and the most common cause of cancer mortality in this population, combined interventions that address both early detection and dietary patterns could help reduce both morbidity and mortality associated with breast cancer in this underserved population. Mujeres Felices por ser Saludables was randomized intervention study designed to assess the efficacy of an 8-month combined dietary and breast health intervention to reduce fat and increase fiber intake as well as to increase the frequency and proficiency of breast self-examination (BSE) and reduce anxiety related to BSE among Latinas. Blocked randomization in blocks of 6 was used to randomize 256 20- to 40-year-old Latinas to the intervention (n = 127) or control group (n = 129). The intervention group attended an 8-month multicomponent education program designed specifically for low-acculturated Latinas. The control group received mailed health education material on a schedule comparable to the intervention. A total of 195 women (76.2%) completed both the baseline and 8-month follow-up interviews. The intervention and control groups were similar on baseline sociodemographic characteristics. At the 8-month follow up, the intervention group reported lower dietary fat (P < .001) and higher fiber intake (p = .06); a higher proportion reported practicing BSE at the recommended interval (p < .001) and showed improved BSE proficiency (p < .001) compared to the control group. BSE-related anxiety was low for both groups at baseline, and no difference in reduction was observed. This project provides a successful model for achieving dietary change and improving breast health behavior in young, low-acculturated Latinas.

Treatment of fatigue with methylphenidate, modafinil and amantadine in multiple sclerosis (TRIUMPHANT-MS): Study design for a pragmatic, randomized, double-blind, crossover clinical trial.

PubMed

Nourbakhsh, Bardia; Revirajan, Nisha; Waubant, Emmanuelle

2018-01-01

Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used fatigue medications in patients with MS. The study is a randomized, placebo-controlled, crossover, four-sequence, four-period, double-blind, multicenter trial of three commonly used medications for the treatment of MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued subjects with MS. Adult patients with MS, with an Expanded Disability Status Scale of <7.0 are eligible to participate. Participants will be randomized to one of four predefined sequences of medication administration. Each sequence comprises four 6-week periods of treatment with one of the 3 study drugs or placebo, and three 2-week washout periods between medication periods. 136 participants will be randomized over two years in two academic centers in the United States starting in the Summer 2017. Complete enrollment is expected by early 2019. The primary outcome of the study is the modified fatigue impact scale (MFIS) score while participants receive the maximally tolerated dose of each study medication (or placebo). Safety and tolerability of the medications and heterogeneity of treatment effect will also be assessed. Results of the proposed study will provide evidence-based and personalized treatment options for patients affected by MS-related fatigue. Clinicaltrials.gov registration number: NCT03185065. Copyright © 2017 Elsevier Inc. All rights reserved.

Improving health outcomes for youth living with the human immunodeficiency virus: a multisite randomized trial of a motivational intervention targeting multiple risk behaviors.

PubMed

Naar-King, Sylvie; Parsons, Jeffrey T; Murphy, Debra A; Chen, Xinguang; Harris, D Robert; Belzer, Marvin E

2009-12-01

To determine if Healthy Choices, a motivational interviewing intervention targeting multiple risk behaviors, improved human immunodeficiency virus (HIV) viral load. A randomized, 2-group repeated measures design with analysis of data from baseline and 6- and 9-month follow-up collected from 2005 to 2007. Five US adolescent medicine HIV clinics. A convenience sample with at least 1 of 3 risk behaviors (nonadherence to HIV medications, substance abuse, and unprotected sex) was enrolled. The sample was aged 16 to 24 years and primarily African American. Of the 205 enrolled, 19 did not complete baseline data collections, for a final sample size of 186. Young people living with HIV were randomized to the intervention plus specialty care (n = 94) or specialty care alone (n = 92). The 3- and 6-month follow-up rates, respectively, were 86% and 82% for the intervention group and 81% and 73% for controls. Intervention Healthy Choices was a 4-session individual clinic-based motivational interviewing intervention delivered during a 10-week period. Motivational interviewing is a method of communication designed to elicit and reinforce intrinsic motivation for change. Outcome Measure Plasma viral load. Youth randomized to Healthy Choices showed a significant decline in viral load at 6 months postintervention compared with youth in the control condition (beta = -0.36, t = -2.15, P = .03), with those prescribed antiretroviral medications showing the lowest viral loads. Differences were no longer significant at 9 months. A motivational interviewing intervention targeting multiple risk behaviors resulted in short-term improvements in viral load for youth living with HIV. Trial Registration clinicaltrials.gov Identifier: NCT00103532.

Evaluation of a cancer patient navigation program ("Onkolotse") in terms of hospitalization rates, resource use and healthcare costs: rationale and design of a randomized, controlled study.

PubMed

Porzig, Ralf; Neugebauer, Sina; Heckmann, Thomas; Adolf, Daniela; Kaskel, Peter; Froster, Ursula G

2018-06-05

Concepts for the nursing and care of cancer patients through a "navigation service" have attracted much interest. However, there is still room for improvement in terms of their funding and coverage. The Saxon Cancer Society designed a prospective, randomized, multicenter, longitudinal study with a view to determining the positive effects of a cancer patient navigator program. The objective of this ongoing study is to evaluate the impact of the cancer patient navigation program on cancer patients and cost bearers in Germany. The study population in this evaluation comprises cancer patients with gastric carcinoma, pancreatic carcinoma, colorectal cancer, melanoma or gynecological cancer who have been hospitalized at least once at one of the study centers as well as their relatives, outpatient and inpatient physicians, and cancer nurses. It is planned to randomize 340 cancer patients (stomach, colonic/rectal cancer, gynecological cancer, melanoma) at five centers to an intervention group (care by patient navigators based on standardized operating procedures) or a control group in a one-to-one ratio. The primary target parameter is the number of hospitalizations within the 12-month intervention period. The participants are asked to complete various questionnaires on patient-related outcomes at baseline and at 3 and 12 months (SF 36, HADS, PAM 13, and others). Data on drug therapy, utilization of health services, and medical expenses will also be analyzed. For the first time, the study will provide data on the effectiveness of a patient support program in cancer care in Germany from a randomized trial with a high level of evidence. The study has been registered under DRKS00013199 in the German Clinical Trials Register.

Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial

PubMed Central

Donovan, Heidi; Wang, Stephanie; Weaver, Carrie; Grove, Jillian Rae; Facco, Francesca Lucia

2017-01-01

Background During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. Objectives The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. Methods We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. Results The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users’ experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06). Conclusions We have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system. Trial Registration Clinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk) PMID:29017990

A novel approach to quality improvement in a safety-net practice: concurrent peer review visits.

PubMed

Fiscella, Kevin; Volpe, Ellen; Winters, Paul; Brown, Melissa; Idris, Amna; Harren, Tricia

2010-12-01

Concurrent peer review visits are structured office visits conducted by clinician peers of the primary care clinician that are specifically designed to reduce competing demands, clinical inertia, and bias. We assessed whether a single concurrent peer review visit reduced clinical inertia and improved control of hypertension, hyperlipidemia, and diabetes control among underserved patients. We conducted a randomized encouragement trial to evaluate concurrent peer review visits with a community health center. Seven hundred twenty-seven patients with hypertension, hyperlipidemia, and/or diabetes who were not at goal for systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and/or glycated hemoglobin (A1c) were randomly assigned to an invitation to participate in a concurrent peer review visit or to usual care. We compared change in these measures using mixed models and rates of therapeutic intensification during concurrent peer review visits with control visits. One hundred seventy-one patients completed a concurrent peer review visit. SBP improved significantly (p < .01) more among those completing concurrent peer review visits than among those who failed to respond to a concurrent peer review invitation or those randomized to usual care. There were no differences seen for changes in LDL-C or A1c. Concurrent peer review visits were associated with statistically significant greater clinician intensification of blood pressure (p < .001), lipid (p < .001), and diabetes (p < .005) treatment than either for control visits for patients in either the nonresponse group or usual care group. Concurrent peer review visits represent a promising strategy for improving blood pressure control and improving therapeutic intensification in community health centers.

Racial and Ethnic Differences in the Delivery of the Resources for Enhancing Alzheimer's Caregiver Health II Intervention.

PubMed

Graham-Phillips, Anita; Roth, David L; Huang, Jin; Dilworth-Anderson, Peggye; Gitlin, Laura N

2016-08-01

To determine whether there are racial and ethnicity group differences in Resources for Enhancing Alzheimer's Caregiver Health (REACH II) intervention delivery. Randomized controlled trial. Community-based intervention delivered at five sites across the United States. Family caregivers of persons with dementia who were randomized to the active intervention condition (N = 323). Nine in-home sessions (90 minutes each) and three telephone sessions (30 minutes each) were intended to be delivered and designed to reduce caregiver burden and depression, improve caregiver self-care and social support, and help caregivers manage behavior problems in persons with dementia. Interventionists recorded the type of intervention (home or telephone), start and stop times, and whether specific intervention content modules (e.g., stress management, social support) were administered in each session. Overall, REACH II intervention delivery was high, with more than 80% of randomized caregivers completing at least five in-home sessions and receiving eight or more hours of intervention contact, but black caregivers completed fewer in-home sessions (mean 6.98) than Hispanics (mean 7.84) or whites (mean 8.25) and received less total intervention contact time (mean 683 minutes) than Hispanics (mean 842 minutes) or whites (mean 798 minutes). No significant differences in exposure to content according to race or ethnicity were found after controlling for demographic covariates. Blacks in REACH II received significantly less intervention contact. Similar multicomponent interventions should examine whether there are systematic differences in intervention delivery across specific demographic subgroups and explore implications for treatment outcomes. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

PubMed Central

Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

2016-01-01

Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP <150/95 mm Hg; intolerant of/at maximum RAASi dose. Protocol. 3-wk screening; Baseline randomization; Urine and blood measures at months 1, 2, 4, and Month 6 study completion. Urine interleukin-6 (IL-6) and osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr) ratio at Month 6 vs Baseline. Results 30 patients completed the study. The 15% decline in U P: Cr in minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

Using a UK Virtual Supermarket to Examine Purchasing Behavior Across Different Income Groups in the United Kingdom: Development and Feasibility Study.

PubMed

Mizdrak, Anja; Waterlander, Wilma Elzeline; Rayner, Mike; Scarborough, Peter

2017-10-09

The majority of food in the United Kingdom is purchased in supermarkets, and therefore, supermarket interventions provide an opportunity to improve diets. Randomized controlled trials are costly, time-consuming, and difficult to conduct in real stores. Alternative approaches of assessing the impact of supermarket interventions on food purchases are needed, especially with respect to assessing differential impacts on population subgroups. The aim of this study was to assess the feasibility of using the United Kingdom Virtual Supermarket (UKVS), a three-dimensional (3D) computer simulation of a supermarket, to measure food purchasing behavior across income groups. Participants (primary household shoppers in the United Kingdom with computer access) were asked to conduct two shopping tasks using the UKVS and complete questionnaires on demographics, food purchasing habits, and feedback on the UKVS software. Data on recruitment method and rate, completion of study procedure, purchases, and feedback on usability were collected to inform future trial protocols. A total of 98 participants were recruited, and 46 (47%) fully completed the study procedure. Low-income participants were less likely to complete the study (P=.02). Most participants found the UKVS easy to use (38/46, 83%) and reported that UKVS purchases resembled their usual purchases (41/46, 89%). The UKVS is likely to be a useful tool to examine the effects of nutrition interventions using randomized controlled designs. Feedback was positive from participants who completed the study and did not differ by income group. However, retention was low and needs to be addressed in future studies. This study provides purchasing data to establish sample size requirements for full trials using the UKVS. ©Anja Mizdrak, Wilma Elzeline Waterlander, Mike Rayner, Peter Scarborough. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 09.10.2017.

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers.

PubMed

Levinson, Arnold H; Valverde, Patricia; Garrett, Kathleen; Kimminau, Michele; Burns, Emily K; Albright, Karen; Flynn, Debra

2015-07-09

A majority of continuing smokers in the United States are socioeconomically disadvantaged (SED) adults, who are less likely than others to achieve and maintain abstinence despite comparable quit-attempt rates. A national research initiative seeks effective new strategies for increasing successful smoking cessation outcomes among SED populations. There is evidence that chronic and acute stressors may interfere with SED smokers who try to quit on their own. Patient navigators have been effectively used to improve adherence to chronic disease treatment. We designed and have pilot-tested an innovative, non-clinical community-based intervention--smoking cessation treatment navigators--to determine feasibility (acceptance, adherence, and uncontrolled results) for evaluation by randomized controlled trial (RCT). The intervention was developed for smokers among parents and other household members of inner city pre-school for low-income children. Smoking cessation treatment navigators were trained and deployed to help participants choose and adhere to evidence-based cessation treatment (EBCT). Navigators provided empathy, resource-linking, problem-solving, and motivational reinforcement. Measures included rates of study follow-up completion, EBCT utilization, navigation participation, perceived intervention quality, 7-day point abstinence and longest abstinence at three months. Both complete-case and intent-to-treat analyses were performed. Eighty-five percent of study participants (n = 40) completed final data collection. More than half (53%) enrolled in a telephone quitline and nearly three-fourths (71%) initiated nicotine replacement therapy. Participants completed a mean 3.4 navigation sessions (mean 30 min duration) and gave the intervention very high quality and satisfaction ratings. Self-reported abstinence was comparable to rates for evidence-based cessation strategies (21% among study completers, 18% using intent-to-treat analysis; median 21 days abstinent among relapsers). The pilot results suggest that smoking cessation treatment navigators are feasible to study in community settings and are well-accepted for increasing use of EBCT among low-income smokers. Randomized controlled trial for efficacy is warranted.

An evaluation of the genetic-matched pair study design using genome-wide SNP data from the European population.

PubMed

Lu, Timothy Tehua; Lao, Oscar; Nothnagel, Michael; Junge, Olaf; Freitag-Wolf, Sandra; Caliebe, Amke; Balascakova, Miroslava; Bertranpetit, Jaume; Bindoff, Laurence Albert; Comas, David; Holmlund, Gunilla; Kouvatsi, Anastasia; Macek, Milan; Mollet, Isabelle; Nielsen, Finn; Parson, Walther; Palo, Jukka; Ploski, Rafal; Sajantila, Antti; Tagliabracci, Adriano; Gether, Ulrik; Werge, Thomas; Rivadeneira, Fernando; Hofman, Albert; Uitterlinden, André Gerardus; Gieger, Christian; Wichmann, Heinz-Erich; Ruether, Andreas; Schreiber, Stefan; Becker, Christian; Nürnberg, Peter; Nelson, Matthew Roberts; Kayser, Manfred; Krawczak, Michael

2009-07-01

Genetic matching potentially provides a means to alleviate the effects of incomplete Mendelian randomization in population-based gene-disease association studies. We therefore evaluated the genetic-matched pair study design on the basis of genome-wide SNP data (309,790 markers; Affymetrix GeneChip Human Mapping 500K Array) from 2457 individuals, sampled at 23 different recruitment sites across Europe. Using pair-wise identity-by-state (IBS) as a matching criterion, we tried to derive a subset of markers that would allow identification of the best overall matching (BOM) partner for a given individual, based on the IBS status for the subset alone. However, our results suggest that, by following this approach, the prediction accuracy is only notably improved by the first 20 markers selected, and increases proportionally to the marker number thereafter. Furthermore, in a considerable proportion of cases (76.0%), the BOM of a given individual, based on the complete marker set, came from a different recruitment site than the individual itself. A second marker set, specifically selected for ancestry sensitivity using singular value decomposition, performed even more poorly and was no more capable of predicting the BOM than randomly chosen subsets. This leads us to conclude that, at least in Europe, the utility of the genetic-matched pair study design depends critically on the availability of comprehensive genotype information for both cases and controls.

Preventing Depression in Later Life: Translation From Concept to Experimental Design and Implementation

PubMed Central

Sriwattanakomen, Roy; Ford, Angela F.; Thomas, Stephen B.; Miller, Mark D.; Stack, Jacqueline A.; Morse, Jennifer Q.; Kasckow, John; Brown, Charlotte; Reynolds, Charles F.

2009-01-01

Objective The authors detail the public health need for depression prevention research and the decisions made in designing an experiment testing problem solving therapy as “indicated” preventive intervention for high-risk older adults with subsyndromal depression. Special attention is given to the recruitment of African Americans because of well-documented inequalities in mental health services and depression treatment outcomes between races. Methods A total of 306 subjects (half white, half African American) with scores of 16 or higher on the Center for Epidemiological Studies of Depression Scale, but with no history of major depressive disorder in the past 12 months, are being recruited and randomly assigned to either problem solving therapy-primary care or to a dietary education control condition. Time to, and rate of, incident episodes of major depressive disorder are to be modeled using survival analysis. Level of depressive symptoms will be analyzed via a mixed models approach. Results Twenty-two subjects have been recruited into the study, and to date eight have completed the randomly assigned intervention and postintervention assessment. Four of 22 have exited after developing major depressive episodes. None have complained about study procedures or demands. Implementation in a variety of community settings is going well. Conclusion The data collected to date support the feasibility of translating from epidemiology to RCT design and implementation of empirical depression prevention research in later life. PMID:18515690

A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal.

PubMed

Ivanova, Anastasia; Tamura, Roy N

2015-12-01

A new clinical trial design, designated the two-way enriched design (TED), is introduced, which augments the standard randomized placebo-controlled trial with second-stage enrichment designs in placebo non-responders and drug responders. The trial is run in two stages. In the first stage, patients are randomized between drug and placebo. In the second stage, placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo. All first-stage data, and second-stage data from first-stage placebo non-responders and first-stage drug responders, are utilized in the efficacy analysis. The authors developed one, two and three degrees of freedom score tests for treatment effect in the TED and give formulae for asymptotic power and for sample size computations. The authors compute the optimal allocation ratio between drug and placebo in the first stage for the TED and compare the operating characteristics of the design to the standard parallel clinical trial, placebo lead-in and randomized withdrawal designs. Two motivating examples from different disease areas are presented to illustrate the possible design considerations. © The Author(s) 2011.

A Bayesian sequential design with adaptive randomization for 2-sided hypothesis test.

PubMed

Yu, Qingzhao; Zhu, Lin; Zhu, Han

2017-11-01

Bayesian sequential and adaptive randomization designs are gaining popularity in clinical trials thanks to their potentials to reduce the number of required participants and save resources. We propose a Bayesian sequential design with adaptive randomization rates so as to more efficiently attribute newly recruited patients to different treatment arms. In this paper, we consider 2-arm clinical trials. Patients are allocated to the 2 arms with a randomization rate to achieve minimum variance for the test statistic. Algorithms are presented to calculate the optimal randomization rate, critical values, and power for the proposed design. Sensitivity analysis is implemented to check the influence on design by changing the prior distributions. Simulation studies are applied to compare the proposed method and traditional methods in terms of power and actual sample sizes. Simulations show that, when total sample size is fixed, the proposed design can obtain greater power and/or cost smaller actual sample size than the traditional Bayesian sequential design. Finally, we apply the proposed method to a real data set and compare the results with the Bayesian sequential design without adaptive randomization in terms of sample sizes. The proposed method can further reduce required sample size. Copyright © 2017 John Wiley & Sons, Ltd.

Random deflections of a string on an elastic foundation.

NASA Technical Reports Server (NTRS)

Sanders, J. L., Jr.

1972-01-01

The paper is concerned with the problem of a taut string on a random elastic foundation subjected to random loads. The boundary value problem is transformed into an initial value problem by the method of invariant imbedding. Fokker-Planck equations for the random initial value problem are formulated and solved in some special cases. The analysis leads to a complete characterization of the random deflection function.

Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial.

PubMed

Anderson, Robert M; Funnell, Martha M; Nwankwo, Robin; Gillard, Mary Lou; Oh, Mary; Fitzgerald, J Thomas

2005-01-01

The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes. The study used a randomized controlled trial (RCT) pretest/post-test design with repeated measures. Patients were randomly assigned to either a six-week intervention group or a six-week wait-listed control group. After completing the six sessions, patients were invited to participate in one of two follow-up conditions; attend a monthly support group or receive a monthly phone call from a nurse. Assessment measures included HbA1C, lipids, blood pressure, weight, self-management behavior and psychosocial adaptation. Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT. These gains were maintained or improved upon during the one-year follow-up period. For patients in the two follow-up conditions, a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values. We believe that results of this study can be attributed to volunteer bias, study effects (ie, providing study data on several occasions to patients and their physicians during the one-year study period), and impact of the interventions. However, the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period.

Treating obstructive sleep apnea in adults with epilepsy

PubMed Central

Malow, B A.; Foldvary-Schaefer, N; Vaughn, B V.; Selwa, L M.; Chervin, R D.; Weatherwax, K J.; Wang, L; Song, Y

2008-01-01

Objective: Small uncontrolled series suggest that treatment of obstructive sleep apnea (OSA) in patients with epilepsy may improve seizure control. Prior to conducting a definitive randomized controlled trial, we addressed critical design issues in a pilot study. Methods: We identified a cohort of adult patients with medically refractory epilepsy and coexisting OSA, documented by polysomnography (PSG). After an 8-week baseline period, subjects with OSA were randomized to therapeutic or sham continuous positive airway pressure (CPAP) for 10 weeks. Subjects maintained seizure calendars and antiepileptic drug dosages were held constant. Results: Sixty-eight subjects with suspected OSA were enrolled and 35 subjects randomized to therapeutic CPAP (22 subjects) or sham (13 subjects) CPAP. Male gender and an elevated sleep apnea questionnaire score were predictive of OSA on PSG. Nineteen subjects in the therapeutic group and all 13 subjects in the sham group completed the trial. Baseline apnea-hypopnea index (AHI) and CPAP adherence were comparable between groups. A significant reduction in AHI was observed in the therapeutic CPAP group as compared to the sham group. Subjects, study coordinators, and principal investigators were unable to predict treatment allocation. Conclusions: This pilot study provided critical information related to study design and feasibility for planning a comprehensive trial to test the hypothesis that treating obstructive sleep apnea in patients with epilepsy improves seizure control. GLOSSARY AEDs = antiepileptic drugs; AHI = apnea-hypopnea index; BMI = body mass index; CPAP = continuous positive airway pressure; OSA = obstructive sleep apnea; PSG = polysomnography. PMID:18711110

Hip Abductor Strengthening Improves Physical Function Following Total Knee Replacement: One-Year Follow-Up of a Randomized Pilot Study.

PubMed

Harikesavan, Karvannan; Chakravarty, Raj D; Maiya, Arun G; Hegde, Sanjay P; Y Shivanna, Shivakumar

2017-01-01

Total knee replacement (TKR) is the commonest surgical procedure for patients with severe pain and impaired physical function following end stage knee osteoarthritis. The hip abductors are well renowned in stabilization of the trunk and hip during walking, maintaining the lower limb position, and transferring the forces from the lower limbs to the pelvis. To assess the efficacy of hip abductor strengthening exercise on functional outcome using performance based outcome measures following total knee replacement. An observer blinded randomized pilot trial design was conducted at Manipal hospital, Bangalore, India. Participants designated for elective TKR were randomized to experimental group hip abductor strengthening along with standard rehabilitation (n=10) or control group standard rehabilitation alone (n=10). Participants followed for one year to assess physical function using performance based outcomes, such as timed up and go test, single leg stance test, six minute walk test, knee extensor strength and hip abductor strength. Eighteen participants with a mean age of 63.1 ± 5.5 years (8 Males and 10 Females) completed the study. Improvement in hip abduction strength, single leg stand test was superior in hip abductor strengthening group at 3 months and 1 year when compared to standard rehabilitation alone. Hip abductor strengthening showed superior improvements in single leg stance test and six minute walk test. Hip abductor strengthening exercises has the potential to improve physical function following total knee replacement.

Hip Abductor Strengthening Improves Physical Function Following Total Knee Replacement: One-Year Follow-Up of a Randomized Pilot Study

PubMed Central

Harikesavan, Karvannan; Chakravarty, Raj D.; Maiya, Arun G; Hegde, Sanjay P.; Y. Shivanna, Shivakumar

2017-01-01

Background: Total knee replacement (TKR) is the commonest surgical procedure for patients with severe pain and impaired physical function following end stage knee osteoarthritis. The hip abductors are well renowned in stabilization of the trunk and hip during walking, maintaining the lower limb position, and transferring the forces from the lower limbs to the pelvis. Objective: To assess the efficacy of hip abductor strengthening exercise on functional outcome using performance based outcome measures following total knee replacement. Methods: An observer blinded randomized pilot trial design was conducted at Manipal hospital, Bangalore, India. Participants designated for elective TKR were randomized to experimental group hip abductor strengthening along with standard rehabilitation (n=10) or control group standard rehabilitation alone (n=10). Participants followed for one year to assess physical function using performance based outcomes, such as timed up and go test, single leg stance test, six minute walk test, knee extensor strength and hip abductor strength. Result: Eighteen participants with a mean age of 63.1 ± 5.5 years (8 Males and 10 Females) completed the study. Improvement in hip abduction strength, single leg stand test was superior in hip abductor strengthening group at 3 months and 1 year when compared to standard rehabilitation alone. Conclusion: Hip abductor strengthening showed superior improvements in single leg stance test and six minute walk test. Hip abductor strengthening exercises has the potential to improve physical function following total knee replacement. PMID:28567148

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study.

PubMed

Bier, Nathalie; Grenier, Sébastien; Brodeur, Catherine; Gauthier, Serge; Gilbert, Brigitte; Hudon, Carol; Lepage, Émilie; Ouellet, Marie-Christine; Viscogliosi, Chantal; Belleville, Sylvie

2015-03-01

Several studies have suggested that cognitive training is a potentially effective way to improve cognition and postpone cognitive decline in older adults with mild cognitive impairment (MCI). The MEMO+ study is a randomized, controlled, single-blind trial designed to test the efficacy, specificity, and long-term effect of a cognitive training intervention and a psychosocial intervention in persons with MCI. One hundred and sixty-two participants with MCI will be recruited. They will be randomized into three groups: cognitive training, psychosocial intervention, and no-contact. Each intervention will last for eight weeks (one session per week) and a booster training session will be provided three months after the end of the intervention. Various proximal and distal outcomes will be measured at pre-intervention as well as at one week, three months, and six months post-training. Proximal outcomes include memory and psychological health measures. Distal outcomes focus on self-rated functioning in complex daily activities and strategies used in daily life to enhance function. Socio-demographic factors (age, gender, and education), general cognition, personality traits, engagement in activities, and self-efficacy will be used as moderators. Enrolment began in April 2012 and will be completed by December 2014. This study is likely to have a significant impact on the well-being of persons with MCI by contributing to the development of adapted and scientifically supported cognitive and psychosocial interventions.

A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

ERIC Educational Resources Information Center

Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

2016-01-01

Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

[The 'Beijing clinical database' on severe acute respiratory syndrome patients: its design, process, quality control and evaluation].

PubMed

2004-04-01

To develop a large database on clinical presentation, treatment and prognosis of all clinical diagnosed severe acute respiratory syndrome (SARS) cases in Beijing during the 2003 "crisis", in order to conduct further clinical studies. The database was designed by specialists, under the organization of the Beijing Commanding Center for SARS Treatment and Cure, including 686 data items in six sub-databases: primary medical-care seeking, vital signs, common symptoms and signs, treatment, laboratory and auxiliary test, and cost. All hospitals having received SARS inpatients were involved in the project. Clinical data was transferred and coded by trained doctors and data entry was carried out by trained nurses, according to a uniformed protocol. A series of procedures had been taken before the database was finally established which included programmed logic checking, digit-by-digit check on 5% random sample, data linkage for transferred cases, coding of characterized information, database structure standardization, case reviewe by computer program according to SARS Clinical Diagnosis Criteria issued by the Ministry of Health, and exclusion of unqualified patients. The database involved 2148 probable SARS cases in accordant with the clinical diagnosis criteria, including 1291 with complete records. All cases and record-complete cases showed an almost identical distribution in sex, age, occupation, residence areas and time of onset. The completion rate of data was not significantly different between the two groups except for some items on primary medical-care seeking. Specifically, the data completion rate was 73% - 100% in primary medical-care seeking, 90% in common symptoms and signs, 100% for treatment, 98% for temperature, 90% for pulse, 100% for outcomes and 98% for costs in hospital. The number of cases collected in the Beijing Clinical Database of SARS Patients was fairly complete. Cases with complete records showed that they could serve as excellent representatives of all cases. The completeness of data was quite satisfactory with primary clinical items which allowed for further clinical studies.

Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial.

PubMed

Gelli, Aulo; Becquey, Elodie; Ganaba, Rasmane; Headey, Derek; Hidrobo, Melissa; Huybregts, Lieven; Verhoef, Hans; Kenfack, Romain; Zongouri, Sita; Guedenet, Hannah

2017-09-06

The SELEVER study is designed to evaluate the impact of an integrated agriculture-nutrition package of interventions (including poultry value chain development, women's empowerment activities, and a behavior change communications strategy to promote improved diets and feeding, care, and hygiene practices) on the diets, health, and nutritional status of women and children in Burkina Faso. This paper presents the rationale and study design. The impact evaluation involves a cluster randomized controlled trial design that will be implemented in 120 rural communities/villages within 60 communes supported by SELEVER in the Boucle de Mouhoun, Centre-Ouest, and Haut-Bassins regions of Burkina Faso. Communities will be randomly assigned to one of three treatment arms, including: (1) SELEVER intervention group; (2) SELEVER with an intensive WASH component; and (3) control group without intervention. Primary outcomes include the mean probability of adequacy of diets for women and children (aged 2-4 years at baseline), infant and young child feeding practices of caregivers of children aged 0-2 years, and household poultry production and sales. Intermediate outcomes along the agriculture and nutrition pathways will also be measured, including child nutrition status and development. The evaluation will follow a mixed-methods approach, including a panel of child-, household-, community-, and market-level surveys, and data collection points during post-harvest and lean seasons, as well as one year after implementation completion to examine sustainability. To our knowledge, this study is the first to rigorously examine from a food systems perspective, the simultaneous impact of scaling-up nutrition-specific and nutrition-sensitive interventions through a livestock value-chain and community-intervention platform, across nutrition, health, and agriculture domains. The findings of this evaluation will provide evidence to support the design of market-based nutrition-sensitive interventions. ISRCTN registry, ISRCTN16686478 . Registered on 2 December 2016.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Trial registration Current Controlled Trials ISRCTN19506752 PMID:21672213

Psychometric testing on the NLN Student Satisfaction and Self-Confidence in Learning, Simulation Design Scale, and Educational Practices Questionnaire using a sample of pre-licensure novice nurses.

PubMed

Franklin, Ashley E; Burns, Paulette; Lee, Christopher S

2014-10-01

In 2006, the National League for Nursing published three measures related to novice nurses' beliefs about self-confidence, scenario design, and educational practices associated with simulation. Despite the extensive use of these measures, little is known about their reliability and validity. The psychometric properties of the Student Satisfaction and Self-Confidence in Learning Scale, Simulation Design Scale, and Educational Practices Questionnaire were studied among a sample of 2200 surveys completed by novice nurses from a liberal arts university in the southern United States. Psychometric tests included item analysis, confirmatory and exploratory factor analyses in randomly-split subsamples, concordant and discordant validity, and internal consistency. All three measures have sufficient reliability and validity to be used in education research. There is room for improvement in content validity with the Student Satisfaction and Self-Confidence in Learning and Simulation Design Scale. This work provides robust evidence to ensure that judgments made about self-confidence after simulation, simulation design and educational practices are valid and reliable. Copyright © 2014 Elsevier Ltd. All rights reserved.

Methodological reporting of randomized trials in five leading Chinese nursing journals.

PubMed

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495].

PubMed

van Hout, Hein P J; Nijpels, Giel; van Marwijk, Harm W J; Jansen, Aaltje P D; Van't Veer, Petronella J; Tybout, Willemijn; Stalman, Wim A B

2005-09-08

The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Main study: The main study concerns a randomized controlled in primary care practices (PCP) with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1) visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2) determine the care priorities together with the patient; (3) design and execute interventions according to protocols; (4) and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search): 1) Vulnerable Elders Screen, 2) Strawbridge's frailty screen, and 3) COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. The design holds several unique elements such as early identification of frail persons combined with case-management by nurses. From two pilots we learned that of three potential postal frailty measures, the COOP-WONCA charts were completed best by elderly and that preventive home visits by nurses were positively evaluated to have potential for quality of care improvement.

Improved variance estimation of classification performance via reduction of bias caused by small sample size.

PubMed

Wickenberg-Bolin, Ulrika; Göransson, Hanna; Fryknäs, Mårten; Gustafsson, Mats G; Isaksson, Anders

2006-03-13

Supervised learning for classification of cancer employs a set of design examples to learn how to discriminate between tumors. In practice it is crucial to confirm that the classifier is robust with good generalization performance to new examples, or at least that it performs better than random guessing. A suggested alternative is to obtain a confidence interval of the error rate using repeated design and test sets selected from available examples. However, it is known that even in the ideal situation of repeated designs and tests with completely novel samples in each cycle, a small test set size leads to a large bias in the estimate of the true variance between design sets. Therefore different methods for small sample performance estimation such as a recently proposed procedure called Repeated Random Sampling (RSS) is also expected to result in heavily biased estimates, which in turn translates into biased confidence intervals. Here we explore such biases and develop a refined algorithm called Repeated Independent Design and Test (RIDT). Our simulations reveal that repeated designs and tests based on resampling in a fixed bag of samples yield a biased variance estimate. We also demonstrate that it is possible to obtain an improved variance estimate by means of a procedure that explicitly models how this bias depends on the number of samples used for testing. For the special case of repeated designs and tests using new samples for each design and test, we present an exact analytical expression for how the expected value of the bias decreases with the size of the test set. We show that via modeling and subsequent reduction of the small sample bias, it is possible to obtain an improved estimate of the variance of classifier performance between design sets. However, the uncertainty of the variance estimate is large in the simulations performed indicating that the method in its present form cannot be directly applied to small data sets.

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

PubMed

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

2015-08-01

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

Shaping electromagnetic waves using software-automatically-designed metasurfaces.

PubMed

Zhang, Qian; Wan, Xiang; Liu, Shuo; Yuan Yin, Jia; Zhang, Lei; Jun Cui, Tie

2017-06-15

We present a fully digital procedure of designing reflective coding metasurfaces to shape reflected electromagnetic waves. The design procedure is completely automatic, controlled by a personal computer. In details, the macro coding units of metasurface are automatically divided into several types (e.g. two types for 1-bit coding, four types for 2-bit coding, etc.), and each type of the macro coding units is formed by discretely random arrangement of micro coding units. By combining an optimization algorithm and commercial electromagnetic software, the digital patterns of the macro coding units are optimized to possess constant phase difference for the reflected waves. The apertures of the designed reflective metasurfaces are formed by arranging the macro coding units with certain coding sequence. To experimentally verify the performance, a coding metasurface is fabricated by automatically designing two digital 1-bit unit cells, which are arranged in array to constitute a periodic coding metasurface to generate the required four-beam radiations with specific directions. Two complicated functional metasurfaces with circularly- and elliptically-shaped radiation beams are realized by automatically designing 4-bit macro coding units, showing excellent performance of the automatic designs by software. The proposed method provides a smart tool to realize various functional devices and systems automatically.

Interpersonal Change in Brief Supportive Psychotherapy

PubMed Central

Rosenthal, Richard N.; Muran, J. Christopher; Pinsker, Henry; Hellerstein, David; Winston, Arnold

1999-01-01

As a substudy of a manual-based outcome study of the Beth Israel Brief Psychotherapy Program, the authors studied the efficacy of supportive psychotherapy in personality change, with particular attention to changes that outlast the period of treatment. They examined results from the Inventory of Interpersonal Problems (IIP) at intake, 40th-session termination, and 6-month follow-up in the first 20 subjects randomized to the supportive group. Eight subjects (40%) dropped out, but their initial IIP scores did not differ from those of follow-up completers. Six of 10 subjects with complete 6-month follow-up data showed significant improvement in interpersonal problems (4 cases P < 0.001; 2 cases P < 0.05). In a case method design, using the IIP mapped to an interpersonal circumplex model, the authors graphically demonstrate lasting positive changes in interpersonal functioning in subjects treated with supportive psychotherapy. (The Journal of Psychotherapy Practice and Research 1999; 8:55–63) PMID:9888107

Relative Effectiveness of Reading Intervention Programs for Adults with Low Literacy.

PubMed

Sabatini, John P; Shore, Jane; Holtzman, Steven; Scarborough, Hollis S

2011-01-01

To compare the efficacy of instructional programs for adult learners with basic reading skills below the seventh grade level, 300 adults were randomly assigned to one of three supplementary tutoring programs designed to strengthen decoding and fluency skills, and gains were examined for the 148 adult students who completed the program. The three intervention programs were based on or adapted from instructional programs that have been shown to benefit children with reading levels similar to those of the adult sample. Each program varied in its relative emphasis on basic decoding versus reading fluency instruction. A repeated measures MANOVA confirmed small to moderate reading gains from pre- to post-testing across a battery of targeted reading measures, but no significant relative differences across interventions. An additional 152 participants who failed to complete the intervention differed initially from those who persisted. Implications for future research and adult literacy instruction are discussed.

Assessing the Robustness of Complete Bacterial Genome Segmentations

NASA Astrophysics Data System (ADS)

Devillers, Hugo; Chiapello, Hélène; Schbath, Sophie; El Karoui, Meriem

Comparison of closely related bacterial genomes has revealed the presence of highly conserved sequences forming a "backbone" that is interrupted by numerous, less conserved, DNA fragments. Segmentation of bacterial genomes into backbone and variable regions is particularly useful to investigate bacterial genome evolution. Several software tools have been designed to compare complete bacterial chromosomes and a few online databases store pre-computed genome comparisons. However, very few statistical methods are available to evaluate the reliability of these software tools and to compare the results obtained with them. To fill this gap, we have developed two local scores to measure the robustness of bacterial genome segmentations. Our method uses a simulation procedure based on random perturbations of the compared genomes. The scores presented in this paper are simple to implement and our results show that they allow to discriminate easily between robust and non-robust bacterial genome segmentations when using aligners such as MAUVE and MGA.

Early outcomes following low dose naltrexone enhancement of opioid detoxification.

PubMed

Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathleen; Gottheil, Edward; Wu, Li-Tzy; Gorelick, David A

2009-01-01

Although withdrawal severity and treatment completion are the initial focus of opioid detoxification, post-detoxification outcome better defines effective interventions. Very low dose naltrexone (VLNTX) in addition to methadone taper was recently associated with attenuated withdrawal intensity during detoxification. We describe the results of a seven-day follow-up evaluation of 96 subjects who completed inpatient detoxification consisting of the addition of VLNTX (0.125 or 0.250 mg per day) or placebo to methadone taper in a double blind, randomized investigation. Individuals receiving VLNTX during detoxification reported reduced withdrawal and drug use during the first 24 hours after discharge. VLNTX addition was also associated with higher rates of negative drug tests for opioids and cannabis and increased engagement in outpatient treatment after one week. Further studies are needed to test the utility of this approach in easing the transition from detoxification to various follow-up treatment modalities designed to address opioid dependence.

Food increases the bioavailability of isotretinoin.

PubMed

Colburn, W A; Gibson, D M; Wiens, R E; Hanigan, J J

1983-01-01

Twenty healthy male subjects received 80 mg (2 X 40 mg SEG capsules) oral isotretinoin separated by two-week washout periods in an open randomized crossover design. Isotretinoin was administered during a complete fast, 1 hour after a standard breakfast, with a standard breakfast, or 1 hour before a standard breakfast. Blood samples were obtained at specific times over a 72-hour period. Isotretinoin blood concentrations were determined by a specific HPLC method. The relative bioavailability (AUC) of isotretinoin was found to be approximately 1.5 to 2 times greater when the dose was administered 1 hour before, concomitantly with, or 1 hour after a meal than when it was given during a complete fast. In addition, because the Cmax value is lower when the dose is administered with food rather than 1 hour after a meal, coadministration of isotretinoin with food may be the best method of administration.

Using Communication Technology to Enhance Interprofessional Education Simulations

PubMed Central

Shrader, Sarah; Shin, Tiffany; Heble, Annie; Kempin, Brian; Miller, Astyn; Patykiewicz, Nick

2016-01-01

Objective. To determine the impact of simulations using an alternative method of communication on students’ satisfaction, attitudes, confidence, and performance related to interprofessional communication. Design. One hundred sixty-three pharmacy students participated in a required applications-based capstone course. Students were randomly assigned to one of three interprofessional education (IPE) simulations with other health professions students using communication methods such as telephone, e-mail, and video conferencing. Assessment. Pharmacy students completed a validated survey instrument, Attitude Toward Healthcare Teams Scale (ATHCTS) prior to and after course participation. Significant positive changes occurred for 5 out of 20 items. Written reflection papers and student satisfaction surveys completed after participation showed positive themes and satisfaction. Course instructors evaluated student performance using rubrics for formative feedback. Conclusion. Implementation of IPE simulations using various methods of communication technology is an effective way for pharmacy schools to incorporate IPE into their curriculum. PMID:26941439

A physical activity program to mobilize older people: a practical and sustainable approach.

PubMed

Jancey, Jonine M; Clarke, Ann; Howat, Peter A; Lee, Andy H; Shilton, Trevor; Fisher, John

2008-04-01

Despite the documented benefits of physical activity, it remains difficult to motivate older adults to start and maintain regular physical activity. This study tested an innovative intervention for mobilizing older adults into a neighborhood-based walking program. Researchers recruited a total of 260 healthy but insufficiently active adults aged 65 to 74 years and randomly selected from the Australian electoral roll from 30 Perth metropolitan neighborhoods. Social cognitive theory guided the design of the program. Researchers collected both qualitative and quantitative data to inform the development, together with ongoing process evaluation. A total of 65% of participants completed the program. Their mean weekly walking time for recreation increased by about 100 min, and 80% of participants reported that they would continue to walk twice per week upon program completion. This practical program is potentially effective and sustainable with respect to mobilizing physically inactive older people.

Effectiveness of Nursing Management Information Systems: A Systematic Review

PubMed Central

Choi, Mona; Yang, You Lee

2014-01-01

Objectives The purpose of this study was to review evaluation studies of nursing management information systems (NMISs) and their outcome measures to examine system effectiveness. Methods For the systematic review, a literature search of the PubMed, CINAHL, Embase, and Cochrane Library databases was conducted to retrieve original articles published between 1970 and 2014. Medical Subject Headings (MeSH) terms included informatics, medical informatics, nursing informatics, medical informatics application, and management information systems for information systems and evaluation studies and nursing evaluation research for evaluation research. Additionally, manag* and admin*, and nurs* were combined. Title, abstract, and full-text reviews were completed by two reviewers. And then, year, author, type of management system, study purpose, study design, data source, system users, study subjects, and outcomes were extracted from the selected articles. The quality and risk of bias of the studies that were finally selected were assessed with the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS) criteria. Results Out of the 2,257 retrieved articles, a total of six articles were selected. These included two scheduling programs, two nursing cost-related programs, and two patient care management programs. For the outcome measurements, usefulness, time saving, satisfaction, cost, attitude, usability, data quality/completeness/accuracy, and personnel work patterns were included. User satisfaction, time saving, and usefulness mostly showed positive findings. Conclusions The study results suggest that NMISs were effective in time saving and useful in nursing care. Because there was a lack of quality in the reviewed studies, well-designed research, such as randomized controlled trials, should be conducted to more objectively evaluate the effectiveness of NMISs. PMID:25405060

Learning style and teaching method preferences of Saudi students of physical therapy

PubMed Central

Al Maghraby, Mohamed A.; Alshami, Ali M.

2013-01-01

Context: To the researchers’ knowledge, there are no published studies that have investigated the learning styles and preferred teaching methods of physical therapy students in Saudi Arabia. Aim: The study was conducted to determine the learning styles and preferred teaching methods of Saudi physical therapy students. Settings and Design: A cross-sectional study design. Materials and Methods: Fifty-three Saudis studying physical therapy (21 males and 32 females) participated in the study. The principal researcher gave an introductory lecture to explain the different learning styles and common teaching methods. Upon completion of the lecture, questionnaires were distributed, and were collected on completion. Statistical Analysis Used: Percentages were calculated for the learning styles and teaching methods. Pearson’s correlations were performed to investigate the relationship between them. Results: More than 45 (85%) of the students rated hands-on training as the most preferred teaching method. Approximately 30 (57%) students rated the following teaching methods as the most preferred methods: “Advanced organizers,” “demonstrations,” and “multimedia activities.” Although 31 (59%) students rated the concrete-sequential learning style the most preferred, these students demonstrated mixed styles on the other style dimensions: Abstract-sequential, abstract-random, and concrete-random. Conclusions: The predominant concrete-sequential learning style is consistent with the most preferred teaching method (hands-on training). The high percentage of physical therapy students whose responses were indicative of mixed learning styles suggests that they can accommodate multiple teaching methods. It is recommended that educators consider the diverse learning styles of the students and utilize a variety of teaching methods in order to promote an optimal learning environment for the students. PMID:24672278

Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

PubMed

Minami, Haruka; Brinkman, Hannah R; Nahvi, Shadi; Arnsten, Julia H; Rivera-Mindt, Monica; Wetter, David W; Bloom, Erika Litvin; Price, Lawrence H; Vieira, Carlos; Donnelly, Remington; McClain, Lauren M; Kennedy, Katherine A; D'Aquila, Erica; Fine, Micki; McCarthy, Danielle E; Graham Thomas, J; Hecht, Jacki; Brown, Richard A

2018-03-01

Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study. In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST). The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5). The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

Influence of post hatch dietary supplementation of fat on performance, carcass cuts and biochemical profile in Ven Cobb broiler.

PubMed

Rai, Komal Prasad; Gendley, M K; Tiwari, S P; Sahu, Tarini; Naik, Surendra Kumar

2015-02-01

The present experiment was conducted to study the effect of post hatch dietary fat supplementation on performance of broiler chicken. A total of 120 day-old Ven Cobb broiler chicks were randomly assigned to 4 treatment groups of 30 chicks in each (three replicates of 10 birds/treatment). The trial lasted for 35 days. The experimental design was a completely randomized design. Four types of diet were formulated for 1(st) week: T1, T2, T3 and T4 contained control diet with no added fat, 2.5, 5 and 7.5% fat, respectively. After 1(st) week post-hatch period chicks were fed ad libitum with the normal basal diet as per Bureau of Indian Standard recommendations till completion of the experiment (8-35 days). Significantly higher (p<0.05) body weight and improved feed conversion ratio (FCR) was recorded in birds fed 5% dietary fat at the end of the experiment whereas, feed intake was not significantly affected. Significantly (p<0.05) higher dressed weight was observed due to 5% fat supplementation than other groups whereas, it was not significant for other carcass cuts. No significant differences were observed in moisture, protein and lipid content of breast and thigh muscle of broiler due to supplemented fat whereas, 2.5% dietary fat significantly (p<0.05) increase the serum HI titer on day 28(th). In biochemical profile, higher serum albumin (g/dl) was recorded due to 5% fat supplementation whereas other biochemical components did not show any significance difference among treatments. It may be concluded that supplementation of fat in broilers diet improves the overall FCR, dressing percentage and gain more body weight.

Composting Phragmites australis Cav. plant material and compost effects on soil and tomato (Lycopersicon esculentum Mill.) growth.

PubMed

Toumpeli, Anna; Pavlatou-Ve, Athina K; Kostopoulou, Sofia K; Mamolos, Andreas P; Siomos, Anastasios S; Kalburtji, Kiriaki L

2013-10-15

Composting organic residues is a friendly to the environment alternative to producing fertilizer. This research was carried out to study the process of composting Phragmites australis Cav. plant material alone or with animal manure on a pilot-scale, to evaluate firstly the quality of the composts produced and secondly, using a pot experiment, the effects of their application on soil physicochemical characteristics and tomato plants development. For the compost production a randomized complete block design was used with five treatments (five compost types) and four replications. For the pot experiment, a completely randomized design was used with 17 treatments (plain soil, soil with synthetic fertilizer and the application of five compost types, at three rates each) and five replications. Compost N increased with composting time, while C/N ratio decreased significantly and by the end it ranged from 43.3 for CM to 22.6 for CY. Compost pH became almost neutral, ranging from 6.73 for CY to 7.21 for CM3Y3AM4 by the end. Compost combinations CY7AM3 and CM7AM3 had a more positive influence on the soil physicochemical characteristics than the others. Soil N, P, Ca and Mg concentrations and the reduction of clay dispersion were the highest when CM7AM3 compost was added. The macro-aggregate stability was the highest for CY7AM3, which also sustained plant growth. The latter compost combination improved most of the soil physicochemical characteristics and plant growth especially, when the application rate was 4% (w/w), which equals to 156 Mg ha(-1). Copyright © 2013 Elsevier Ltd. All rights reserved.

Effect of some Evaporation Matters on Storability of Sunflower ( Helianthus annuus L.) Seed.

PubMed

El-Saidy, Aml E A; El-Hai, K M Abd

This study focuses on finding compounds that are safe to humans and environment, such as propionic and acetic acids that may provide an alternative control of seed-borne pathogens and decrease seed deterioration during storage. The objectives of this study were to reduce sunflower seed deterioration and improve the viability of sunflower seed using environmentally safe organic acids. Propionic and acetic acids were applied on sunflower seed at different concentrations under laboratory conditions during different storage periods. After 6 months storage period, the viability of sunflower seed as well as morphological and physiological characteristics of seedlings were evaluated under greenhouse conditions. Laboratory experiment was conducted in a factorial completely randomized design and randomized complete block design for greenhouse experiment. Propionic and acetic acids at different concentrations showed inhibitory effects on the presence of different fungal genera in all storage periods. Propionic acid was most effective followed by acetic acid. Increasing storage periods from 0-6 months significantly decreased germination percentage, germination energy, seedling characters, survived healthy seedlings and seed oil and protein percentages but dead and rotted seeds, as well as rotted seedlings were increased. Treating sunflower seeds with propionic acid (100%) improved germination criteria, seedling characters and seed chemical characters as well as survival seedlings and minimized the dead seeds, rotted seeds and rotted seedlings as compared with the control under all storage periods. Under greenhouse conditions, the maximum growth parameter and physiological characters (chlorophylls a, b, carotenoids and total phenols) were recorded from seed treated with 100% propionic acid after 6 months of storage. It may be concluded that propionic and acetic acids vapors can have considerable fungicidal activity against sunflower pathogens and improve seed viability. Therefore, it is recommended using 100% propionic acid to reduce deterioration and seed-borne pathogens of sunflower under storage conditions.

Interactive, culturally sensitive education on colorectal cancer screening.

PubMed

Menon, Usha; Szalacha, Laura A; Belue, Rhonda; Rugen, Kathryn; Martin, Kelly R; Kinney, Anita Y

2008-09-01

Increasing colorectal cancer screening (CRCS) can have a substantial positive impact on morbidity and mortality. The purpose of this report is to describe the development and feasibility testing of a computer-based, theory-guided educational program designed to increase CRCS. This mixed-methods study used focus groups and subsequent randomized controlled trial design. Participants (N = 199) were randomized to an intervention or control group; 75% were African American; mean age was 57.36 (SD = 6.8); 71% were male. Previously validated measures on knowledge, beliefs, and screening test adherence were used to establish pre- and post-intervention perceptions. Feasibility was measured by response and completion rates, and participants' perceptions of the program. Before feasibility testing, the program was presented to 2 focus groups. Changes were made to the program based on discussion, leading to a visually appealing, easy to understand and navigate, self-paced program. In the RCT pilot test that followed, of the participants in the intervention group, 80% said the education helped them decide to get CRCS; 49% agreed it helped them overcome barriers; 91% agreed it was useful, 68% thought it raised new concerns about cancer, but only 30% said it made them worry about CRC; 95% agreed their doctor's office should continue giving such education, and 99% said they would inform family about the program. The response rate of 83% demonstrated feasibility of conducting colorectal cancer education in the primary care setting; overall the program was well received; participants averaged 23 minutes to complete it. Participants sought no help from attending data collectors and navigated the revised touch screen program with ease. Computer-based education is feasible in primary care clinics.

Web-based Screening and Brief Intervention for Student Marijuana Use in a University Health Center: Pilot Study to Examine the Implementation of eCHECKUP TO GO in Different Contexts

PubMed Central

Palfai, Tibor P.; Saitz, Richard; Winter, Michael; Brown, Timothy A.; Kypri, Kypros; Goodness, Tracie M.; O’Brien, Lauren M.; Lu, Jon

2014-01-01

This pilot study sought to test the feasibility of procedures to screen students for marijuana use in Student Health Services (SHS) and test the efficacy of a web-based intervention designed to reduce marijuana use and consequences. Students were asked to participate in voluntary screening of health behaviors upon arrival at SHS. One hundred and twenty-three students who used marijuana at least monthly completed assessments and were randomized to one of four intervention conditions in a 2 (Intervention: Marijuana eCHECKUP TO GO vs. Control) × 2 (Site of Intervention: On-site vs. Off-site) between-groups design. Follow-up assessments were conducted online at 3 and 6 months. Latent growth modeling was used to provide effect size estimates for the influence of intervention on outcomes. One thousand and eighty undergraduate students completed screening. The intervention did not influence marijuana use frequency. However, there was evidence of a small overall intervention effect on marijuana-related consequences and a medium effect in stratified analyses in the on-site condition. Analyses of psychological variables showed that the intervention significantly reduced perceived norms regarding peer marijuana use. These findings demonstrate that it is feasible to identify marijuana users in SHS and deliver an automated web-based intervention to these students in different contexts. Effect size estimates suggest that the intervention has some promise as a means of correcting misperceptions of marijuana use norms and reducing marijuana-related consequences. Future work should test the efficacy of this intervention in a full scale randomized controlled trial. PMID:24845164

Web-based screening and brief intervention for student marijuana use in a university health center: pilot study to examine the implementation of eCHECKUP TO GO in different contexts.

PubMed

Palfai, Tibor P; Saitz, Richard; Winter, Michael; Brown, Timothy A; Kypri, Kypros; Goodness, Tracie M; O'Brien, Lauren M; Lu, Jon

2014-09-01

This pilot study sought to test the feasibility of procedures to screen students for marijuana use in Student Health Services (SHS) and test the efficacy of a web-based intervention designed to reduce marijuana use and consequences. Students were asked to participate in voluntary screening of health behaviors upon arrival at SHS. One hundred and twenty-three students who used marijuana at least monthly completed assessments and were randomized to one of four intervention conditions in a 2 (intervention: Marijuana eCHECKUP TO GO vs. control)×2 (site of intervention: on-site vs. off-site) between-groups design. Follow-up assessments were conducted online at 3 and 6 months. Latent growth modeling was used to provide effect size estimates for the influence of intervention on outcomes. One thousand and eighty undergraduate students completed screening. The intervention did not influence marijuana use frequency. However, there was evidence of a small overall intervention effect on marijuana-related consequences and a medium effect in stratified analyses in the on-site condition. Analyses of psychological variables showed that the intervention significantly reduced perceived norms regarding peer marijuana use. These findings demonstrate that it is feasible to identify marijuana users in SHS and deliver an automated web-based intervention to these students in different contexts. Effect size estimates suggest that the intervention has some promise as a means of correcting misperceptions of marijuana use norms and reducing marijuana-related consequences. Future work should test the efficacy of this intervention in a full scale randomized controlled trial. Copyright © 2014 Elsevier Ltd. All rights reserved.

Design and operation of the National Survey of Children with Special Health Care Needs, 2009-2010.

PubMed

Bramlett, Matthew D; Blumberg, Stephen J; Ormson, A Elizabeth; George, Jacquelyn M; Williams, Kim L; Frasier, Alicia M; Skalland, Benjamin J; Santos, Kathleen B; Vsetecka, Danielle M; Morrison, Heather M; Pedlow, Steven; Wang, Fang

2014-11-01

This report presents the development, plan, and operation of the 2009-2010 National Survey of Children with Special Health Care Needs, a module of the State and Local Area Integrated Telephone Survey. The survey is conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics. This survey was designed to produce national and state-specific prevalence estimates of children with special health care needs (CSHCN), to describe the types of services that they need and use, and to assess aspects of the system of care for CSHCN. A random-digit-dial sample of households with children under age 18 years was constructed for each of the 50 states and the District of Columbia. The sampling frame consisted of landline phone numbers and cellular(cell) phone numbers of households that reported a cell-phone-only or cell-phone-mainly status. Children in identified households were screened for special health care needs. If CSHCN were identified in the household, a detailed interview was conducted for one randomly selected child with special health care needs. Respondents were parents or guardians who knew about the children's health and health care. A total of 196,159 household screening interviews were completed from July 2009 through March 2011, resulting in 40,242 completed special-needs interviews, including 2,991 from cell-phone interviews. The weighted overall response rate was 43.7% for the landline sample, 15.2% for the cell-phone sample, and 25.5% overall. All material appearing in this report is in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated.

Designing Studies That Would Address the Multilayered Nature of Health Care

PubMed Central

Pennell, Michael; Rhoda, Dale; Hade, Erinn M.; Paskett, Electra D.

2010-01-01

We review design and analytic methods available for multilevel interventions in cancer research with particular attention to study design, sample size requirements, and potential to provide statistical evidence for causal inference. The most appropriate methods will depend on the stage of development of the research and whether randomization is possible. Early on, fractional factorial designs may be used to screen intervention components, particularly when randomization of individuals is possible. Quasi-experimental designs, including time-series and multiple baseline designs, can be useful once the intervention is designed because they require few sites and can provide the preliminary evidence to plan efficacy studies. In efficacy and effectiveness studies, group-randomized trials are preferred when randomization is possible and regression discontinuity designs are preferred otherwise if assignment based on a quantitative score is possible. Quasi-experimental designs may be used, especially when combined with recent developments in analytic methods to reduce bias in effect estimates. PMID:20386057

Blocking for Sequential Political Experiments

PubMed Central

Moore, Sally A.

2013-01-01

In typical political experiments, researchers randomize a set of households, precincts, or individuals to treatments all at once, and characteristics of all units are known at the time of randomization. However, in many other experiments, subjects “trickle in” to be randomized to treatment conditions, usually via complete randomization. To take advantage of the rich background data that researchers often have (but underutilize) in these experiments, we develop methods that use continuous covariates to assign treatments sequentially. We build on biased coin and minimization procedures for discrete covariates and demonstrate that our methods outperform complete randomization, producing better covariate balance in simulated data. We then describe how we selected and deployed a sequential blocking method in a clinical trial and demonstrate the advantages of our having done so. Further, we show how that method would have performed in two larger sequential political trials. Finally, we compare causal effect estimates from differences in means, augmented inverse propensity weighted estimators, and randomization test inversion. PMID:24143061