The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned.

PubMed

Yusen, Roger D; Criner, Gerard J; Sternberg, Alice L; Au, David H; Fuhlbrigge, Anne L; Albert, Richard K; Casaburi, Richard; Stoller, James K; Harrington, Kathleen F; Cooper, J Allen D; Diaz, Philip; Gay, Steven; Kanner, Richard; MacIntyre, Neil; Martinez, Fernando J; Piantadosi, Steven; Sciurba, Frank; Shade, David; Stibolt, Thomas; Tonascia, James; Wise, Robert; Bailey, William C

2018-01-01

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Rationale and Design of the Echocardiographic Study of Hispanics/Latinos (ECHO-SOL).

PubMed

Rodriguez, Carlos J; Dharod, Ajay; Allison, Matthew A; Shah, Sanjiv J; Hurwitz, Barry; Bangdiwala, Shrikant I; Gonzalez, Franklyn; Kitzman, Dalane; Gillam, Linda; Spevack, Daniel; Dadhania, Rupal; Langdon, Sarah; Kaplan, Robert

2015-01-01

Information regarding the prevalence and determinants of cardiac structure and function (systolic and diastolic) among the various Hispanic background groups in the United States is limited. The Echocardiographic Study of Latinos (ECHO-SOL) ancillary study recruited 1,824 participants through a stratified-sampling process representative of the population-based Hispanic Communities Health Study - Study of Latinos (HCHS-SOL) across four sites (Bronx, NY; Chicago, Ill; San Diego, Calif; Miami, Fla). The HCHS-SOL baseline cohort did not include an echo exam. ECHO-SOL added the echocardiographic assessment of cardiac structure and function to an array of existing HCHS-SOL baseline clinical, psychosocial, and socioeconomic data and provides sufficient statistical power for comparisons among the Hispanic subgroups. Standard two-dimensional (2D) echocardiography protocol, including M-mode, spectral, color and tissue Doppler study was performed. The main objectives were to: 1) characterize cardiac structure and function and its determinants among Hispanics and Hispanic subgroups; and 2) determine the contributions of specific psychosocial factors (acculturation and familismo) to cardiac structure and function among Hispanics. We describe the design, methods and rationale of currently the largest and most comprehensive study of cardiac structure and function exclusively among US Hispanics. ECHO-SOL aims to enhance our understanding of Hispanic cardiovascular health as well as help untangle the relative importance of Hispanic subgroup heterogeneity and sociocultural factors on cardiac structure and function.

Rationale, design and methods of the HEALTHY study behavior intervention component

PubMed Central

Venditti, EM; Elliot, DL; Faith, MS; Firrell, LS; Giles, CM; Goldberg, L; Marcus, MD; Schneider, M; Solomon, S; Thompson, D; Yin, Z

2009-01-01

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data informed the development of the behavior intervention component. Principles of social learning and health-related behavior change were incorporated. One element of the behavior intervention component was a sequence of peer-led, teacher-facilitated learning activities known as FLASH (Fun Learning Activities for Student Health). Five FLASH modules were implemented over five semesters of the HEALTHY study, with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade. Each module contained sessions that were designed to be delivered on a weekly basis to foster self-awareness, knowledge, decision-making skills and peer involvement for health behavior change. FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity. Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student's lifestyle change choices. Family outreach strategies included the delivery of newsletters and supplemental packages with materials to promote healthy behavior in the home environment during school summer and winter holiday breaks. In conclusion, the HEALTHY behavior intervention component, when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns, is a feasible and

Improving physical activity in arthritis clinical trial (IMPAACT): study design, rationale, recruitment, and baseline data.

PubMed

Chang, Rowland W; Semanik, Pamela A; Lee, Jungwha; Feinglass, Joseph; Ehrlich-Jones, Linda; Dunlop, Dorothy D

2014-11-01

Over 21 million Americans report an arthritis-attributable activity limitation. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of the most common/disabling forms of arthritis. Various forms of physical activity (PA) can improve a variety of health outcomes and reduce health care costs, but the proportion of the US population engaging in the recommended amount of PA is low and even lower among those with arthritis. The Improving Motivation for Physical Activity in Arthritis Clinical Trial (IMPAACT) is a randomized clinical trial that studied the effects of a lifestyle PA promotion intervention on pain and physical function outcomes. The IMPAACT intervention was based on a chronic care/disease management model in which allied health professionals promote patient self-management activities outside of traditional physician office encounters. The program was a motivational interviewing-based, individualized counseling and referral intervention, directed by a comprehensive assessment of individual patient barriers and strengths related to PA performance. The specific aims of IMPAACT were to test the efficacy of the IMPAACT intervention for persons with arthritis (N=185 persons with RA and 155 persons with knee OA) in improving arthritis-specific and generic self-reported pain and Physical Function outcomes, observed measures of function, and objectively measured and self-reported PA levels. Details of the stratified-randomized study design, subject recruitment, and data collection are described. The results from IMPAACT will generate empiric evidence pertaining to increasing PA levels in persons with arthritis and result in widely applicable strategies for health behavior change. Copyright © 2014 Elsevier Inc. All rights reserved.

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital.

PubMed

Rowlands, Ceri; Rooshenas, Leila; Fairhurst, Katherine; Rees, Jonathan; Gamble, Carrol; Blazeby, Jane M

2018-02-02

To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more 'real' RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

STARPROBE: Scientific rationale

NASA Technical Reports Server (NTRS)

Underwood, J. H. (Editor); Randolph, J. E. (Editor)

1982-01-01

The scientific rationale and instrumentation problems in the areas of solar internal dynamics and relativity, solar plasma and particle dynamics, and solar atmosphere structure were studied. Current STARPROBE mission and system design concepts are summarized.

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

PubMed

Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

2017-04-01

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization

Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.

PubMed

Rutledge, Thomas; Nidich, Sanford; Schneider, Robert H; Mills, Paul J; Salerno, John; Heppner, Pia; Gomez, Mayra A; Gaylord-King, Carolyn; Rainforth, Maxwell

2014-09-01

Although meditation therapies such as the Transcendental Meditation (TM) technique are commonly used to assist with stress and stress-related diseases, there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness. This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder (PTSD) in a Veteran population. This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure (PE) - and an active control condition (health education [HE]) for PTSD. This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD, with testing conducted at 0 and 3 months for PTSD symptoms, depression, mood disturbance, quality of life, behavioral factors, and physiological/biochemical and gene expression mechanisms using validated measures. The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms, using the Clinician Administered PTSD Scale (CAPS). The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD. The projected results will help to establish the overall efficacy of TM for PTSD among Veterans, identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms, and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD. Published by Elsevier Inc.

Psychosocial rehabilitation after war trauma with adaptive disclosure: Design and rationale of a comparative efficacy trial.

PubMed

Yeterian, Julie D; Berke, Danielle S; Litz, Brett T

2017-10-01

Posttraumatic stress disorder (PTSD) from warzone exposure is associated with chronic and disabling social and occupational problems. However, functional impairment is rarely assessed or targeted directly in PTSD treatments, which instead focus on symptom reduction. Trauma-related contributors to diminished functioning, including guilt, shame, and anger resulting from morally compromising or loss-based war experiences, are also underemphasized. The goal of this clinical trial is to fill a substantial gap in the treatment of military-related PTSD by testing a modified Adaptive Disclosure (AD) therapy for war-related PTSD stemming from moral injury and traumatic loss focused on improving psychosocial functioning AD. This paper describes the rationale and design of a multi-site randomized controlled trial comparing AD to Present-Centered Therapy (PCT). We will recruit 186 veterans with PTSD, who will be assessed at baseline, post-treatment, and 3- and 6-months post-treatment. Primary outcomes are functional changes (i.e., functioning/disability and quality of life). Secondary outcomes are mental health variables (i.e., PTSD, depression, guilt, shame). We hypothesize that veterans treated with AD will experience greater improvements in all outcomes compared to those treated with PCT. This trial will advance knowledge in rehabilitation research by testing the first therapy specifically designed to address psychosocial functioning among veterans with war-related PTSD. The results may improve the quality of mental health care for veterans by offering an ecologically sound treatment for experiences that are uniquely impactful for war veterans. Published by Elsevier Inc.

Rationale, design and baseline data of a mixed methods study examining the clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: the DON'T RETARD project.

PubMed

Hilderson, Deborah; Westhovens, Rene; Wouters, Carine; Van der Elst, Kristien; Goossens, Eva; Moons, Philip

2013-12-02

To describe (1) the content of a transition programme for young people with juvenile idiopathic arthritis (JIA) designed as a brief intervention, (2) the rationale and design of a mixed-methods study evaluating the clinical impact of this transition programme and (3) to provide baseline data of the intervention group. An 'embedded experimental' design is used for the evaluation of the transition programme. A 'one-group pretest-posttest, with a non-equivalent posttest-only comparison group design' is used to quantitatively evaluate the impact of the transition programme, applying both longitudinal and comparative analyses. Subsequently, experiences of adolescents and their parents who participated in the experimental group will be analysed qualitatively using content analysis. Participants in the intervention are recruited at a tertiary care centre in Belgium. The comparison group participants are recruited from one tertiary and three secondary care centres in Belgium. The intervention group consists of 33 young people (25 females; 8 males) with a median age of 16 years. Main diagnoses are persistent or extended oligoarticular JIA (33%), polyarticular JIA (30%), enthesitis-related JIA (21%) or systemic arthritis (15%). The transition programme comprises eight key components: (1) transition coordinator; (2) providing information and education; (3) availability by telephone; (4) information about and contact with an adult care programme; (5) guidance of parents; (6) meeting with peers; (7) transfer plan; and (8) actual transfer to adult care. The primary outcome is health status, as perceived by the adolescents. Secondary outcomes are health status, as perceived by the parents; medication adherence; illness-related knowledge; quality of life; fatigue; promotion of independence; support of autonomy; behavioural control and psychological control. At baseline, the median score was 69.2 (Q1=60.0;Q3=92.9) on psychosocial health and 68.8 (Q1=56.3; Q3=89.1) on physical

Rationale and design of the Tanzania Vitamin and HIV Infection Trial.

PubMed

Fawzi, W W; Msamanga, G I; Spiegelman, D; Urassa, E J; Hunter, D J

1999-02-01

We present the rationale and design of a randomized, double-blind, placebo-controlled trial of vitamin supplements among HIV-positive pregnant women in Dar es Salaam, Tanzania. Higher levels of intake of vitamins A, B, C, and E may decrease the risk of vertical transmission and progression of HIV infection by enhancing maternal and infant immune function; by reducing viral load in the blood, breast milk, or lower genital tract secretions; and/or by strengthening the placental barrier to infection. Eligible pregnant women were randomized to receive vitamin A, multivitamins excluding A, vitamin A and multivitamins, or placebo. The main endpoints include vertical transmission of HIV infection, as assessed by examination of infection in infants using polymerase chain reaction (PCR), and progression of HIV disease as measured by the WHO clinical staging system. Over a period of 2 years, 13,876 women were tested for HIV infection, with appropriate pre- and posttest counseling, to enroll 1085 consenting HIV-positive women. The trial assesses women and their children once a month for a minimum of 18 months after delivery or up to the end of this 5-year study. We examine recruitment strategies and means of enhancing cohort retention in long-term follow-up. We assess compliance with the use of supplements by direct questioning, by counting pills, and biochemically by using serum beta-carotene and urine riboflavin levels. Briefly, we discuss ethical issues related to the conduct of AIDS prevention trials in this setting. In sub-Saharan Africa, most HIV-infected persons lack access to the relevant antiretroviral and prophylactic drugs, and the region urgently needs low-cost treatments and preventive strategies. The Tanzania trial should provide valuable data to address the effect of vitamin supplements in the transmission and progression of HIV infection.

Age-related changes relevant to health in women: design, recruitment, and retention strategies for the Longitudinal Assessment of Women (LAW) study.

PubMed

Khoo, Soo Keat; O'Neill, Sheila; Travers, Catherine; Oldenburg, Brian

2008-01-01

The primary aim was to assess the age-related changes that occur in older women. This paper describes the study rationale and methods, recruitment, and retention strategies. The Longitudinal Assessment of Women (LAW) Study was a longitudinal, observational, and multidisciplinary evaluation of a population-based cohort of urban-living women, aged between 40 and 80 years at recruitment and randomly invited from a district in Brisbane (a city in Australia) via the electoral roll. Five hundred eleven women were recruited and stratified into four age groups (40-49, 50-59, 60-69, 70-79 years) and were assessed on three or four occasions each year, using interviews and diagnostic instruments (echocardiography, applination tonometry, dual-energy x-ray absorptiometry [DEXA]) Retention strategies included flexibility, accessibility, personalized attention, and feedback. From a sample frame of 1598 names, there were 1082 respondents, of whom 511 (47%) were successfully recruited from those eligible to participate. Recruitment was quickest for the oldest age group, 70-79 years, and slowest for the age group 40-49 years; all age groups achieved their required quota. A scheduling program was developed to minimize the number of visits and maximize the use of allocated time. The largest dropout was seen in year 1 of the study, with very few thereafter. Of the 9 deaths, cancer was the cause in 7. The retention rate after 5 years was 95.5%. The design of the present study, with careful attention to coordination and a personal approach, facilitated the completion of a 5-year study, enabling a collection of a set of wide-ranging data from almost all the women recruited. The information thus collected will form the basis of cross-linking analysis of the risk factors associated with health problems in aging women.

Better exercise adherence after treatment for cancer (BEAT Cancer) study: Rationale, design, and methods

PubMed Central

Rogers, Laura Q.; McAuley, Edward; Anton, Philip M.; Courneya, Kerry S.; Vicari, Sandra; Hopkins-Price, Patricia; Verhulst, Steven; Mocharnuk, Robert; Hoelzer, Karen

2011-01-01

Most breast cancer survivors do not engage in regular physical activity. Our physical activity behavior change intervention for breast cancer survivors significantly improved physical activity and health outcomes post-intervention during a pilot, feasibility study. Testing in additional sites with a larger sample and longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, enhancing our potential for testing mechanisms mediating physical activity behavior change. Here, we report the rationale, design, and methods for a two-site, randomized controlled trial comparing the effects of the BEAT Cancer physical activity behavior change intervention to usual care on short and longer term physical activity adherence among breast cancer survivors. Secondary aims include examining social cognitive theory mechanisms of physical activity behavior change and health benefits of the intervention. Study recruitment goal is 256 breast cancer survivors with a history of ductal carcinoma in situ or Stage I, II, or IIIA disease who have completed primary cancer treatment. Outcome measures are obtained at baseline, 3 months (i.e., immediately post-intervention), 6 months, and 12 months and include physical activity, psychosocial factors, fatigue, sleep quality, lower extremity joint dysfunction, cardiorespiratory fitness, muscle strength, and waist-to-hip ratio. Confirming behavior change effectiveness, health effects, and underlying mechanisms of physical activity behavior change interventions will facilitate translation to community settings for improving the health and well-being of breast cancer survivors. PMID:21983625

Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

PubMed

Turner, E L; Metcalfe, C; Donovan, J L; Noble, S; Sterne, J A C; Lane, J A; Avery, K N; Down, L; Walsh, E; Davis, M; Ben-Shlomo, Y; Oliver, S E; Evans, S; Brindle, P; Williams, N J; Hughes, L J; Hill, E M; Davies, C; Ng, S Y; Neal, D E; Hamdy, F C; Martin, R M

2014-06-10

Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50-69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up. Among randomised practices, 271 (68%) in the intervention arm (198,114 men) and 302 (78%) in the control arm (221,929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices). The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.

Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

ERIC Educational Resources Information Center

Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

2008-01-01

This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

Design, rationale and feasibility of a multidimensional experimental protocol to study early life stress.

PubMed

Bartholomeusz, M Dillwyn; Bolton, Philip S; Callister, Robin; Skinner, Virginia; Hodgson, Deborah

2017-09-01

There is a rapidly accumulating body of evidence regarding the influential role of early life stress (ELS) upon medical and psychiatric conditions. While self-report instruments, with their intrinsic limitations of recall, remain the primary means of detecting ELS in humans, biological measures are generally limited to a single biological system. This paper describes the design, rationale and feasibility of a study to simultaneously measure neuroendocrine, immune and autonomic nervous system (ANS) responses to psychological and physiological stressors in relation to ELS. Five healthy university students were recruited by advertisement. Exclusion criteria included chronic medical conditions, psychotic disorders, needle phobia, inability to tolerate pain, and those using anti-inflammatory medications. They were clinically interviewed and physiological recordings made over a two-hour period pre, during and post two acute stressors: the cold pressor test and recalling a distressing memory. The Childhood Trauma Questionnaire and the Parental Bonding Index were utilised to measure ELS. Other psychological measures of mood and personality were also administered. Measurements of heart rate, blood pressure, respiratory rate, skin conductance, skin blood flow and temporal plasma samples were successfully obtained before, during and after acute stress. Participants reported the extensive psychological and multisystem physiological data collection and stress provocations were tolerable. Most (4/5) participants indicated a willingness to return to repeat the protocol, indicating acceptability. Our protocol is viable and safe in young physically healthy adults and allows us to assess simultaneously neuroendocrine, immune and autonomic nervous system responses to stressors in persons assessed for ELS.

Rationale, design and baseline data of a mixed methods study examining the clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: the DON'T RETARD project

PubMed Central

Hilderson, Deborah; Westhovens, Rene; Wouters, Carine; Van der Elst, Kristien; Goossens, Eva; Moons, Philip

2013-01-01

Objectives To describe (1) the content of a transition programme for young people with juvenile idiopathic arthritis (JIA) designed as a brief intervention, (2) the rationale and design of a mixed-methods study evaluating the clinical impact of this transition programme and (3) to provide baseline data of the intervention group. Design An ‘embedded experimental’ design is used for the evaluation of the transition programme. A ‘one-group pretest-posttest, with a non-equivalent posttest-only comparison group design’ is used to quantitatively evaluate the impact of the transition programme, applying both longitudinal and comparative analyses. Subsequently, experiences of adolescents and their parents who participated in the experimental group will be analysed qualitatively using content analysis. Setting Participants in the intervention are recruited at a tertiary care centre in Belgium. The comparison group participants are recruited from one tertiary and three secondary care centres in Belgium. Participants The intervention group consists of 33 young people (25 females; 8 males) with a median age of 16 years. Main diagnoses are persistent or extended oligoarticular JIA (33%), polyarticular JIA (30%), enthesitis-related JIA (21%) or systemic arthritis (15%). Intervention The transition programme comprises eight key components: (1) transition coordinator; (2) providing information and education; (3) availability by telephone; (4) information about and contact with an adult care programme; (5) guidance of parents; (6) meeting with peers; (7) transfer plan; and (8) actual transfer to adult care. Primary and secondary outcomes The primary outcome is health status, as perceived by the adolescents. Secondary outcomes are health status, as perceived by the parents; medication adherence; illness-related knowledge; quality of life; fatigue; promotion of independence; support of autonomy; behavioural control and psychological control. Results At baseline, the median

Rationale, design and methods of the HEALTHY study behavior intervention component

USDA-ARS?s Scientific Manuscript database

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physic...

Exercise for methamphetamine dependence: rationale, design, and methodology.

PubMed

Mooney, Larissa J; Cooper, Christopher; London, Edythe D; Chudzynski, Joy; Dolezal, Brett; Dickerson, Daniel; Brecht, Mary-Lynn; Peñate, Jose; Rawson, Richard A

2014-01-01

Effective pharmacotherapies to treat methamphetamine (MA) dependence have not been identified, and behavioral therapies are marginally effective. Based on behavioral studies demonstrating the potential efficacy of aerobic exercise for improving depressive symptoms, anxiety, cognitive deficits, and substance use outcomes, the study described here is examining exercise as a potential treatment for MA-dependent individuals. This study is randomizing 150 participants with MA dependence at a residential treatment facility for addictive disorders to receive either a thrice-weekly structured aerobic and resistance exercise intervention or a health education condition. Recruitment commenced in March, 2010. Enrollment and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates. Seeking evidence for a possibly effective adjunct to traditional behavioral approaches for treatment of MA dependence, this study is assessing the ability of an 8-week aerobic and resistance exercise protocol to reduce relapse to MA use during a 12-week follow-up period after discharge from residential-based treatment. The study also is evaluating improvements in health and functional outcomes during and after the protocol. This paper describes the design and methods of the study. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study).

PubMed

Walsh, Timothy S; Kydonaki, Kalliopi; Antonelli, Jean; Stephen, Jacqueline; Lee, Robert J; Everingham, Kirsty; Hanley, Janet; Uutelo, Kimmo; Peltola, Petra; Weir, Christopher J

2016-03-04

To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs). 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis. Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period. The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured. Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed. The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex

An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment.

PubMed

Jepson, Marcus; Elliott, Daisy; Conefrey, Carmel; Wade, Julia; Rooshenas, Leila; Wilson, Caroline; Beard, David; Blazeby, Jane M; Birtle, Alison; Halliday, Alison; Stein, Rob; Donovan, Jenny L

2018-07-01

To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties. One in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was "best for them". Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation. The methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation. Copyright © 2018 University of Bristol. Published by Elsevier Inc. All rights reserved.

The 'robust' capture-recapture design allows components of recruitment to be estimated

USGS Publications Warehouse

Pollock, K.H.; Kendall, W.L.; Nichols, J.D.; Lebreton, J.-D.; North, P.M.

1993-01-01

The 'robust' capture-recapture design (Pollock 1982) allows analyses which combine features of closed population model analyses (Otis et aI., 1978, White et aI., 1982) and open population model analyses (Pollock et aI., 1990). Estimators obtained under these analyses are more robust to unequal catch ability than traditional Jolly-Seber estimators (Pollock, 1982; Pollock et al., 1990; Kendall, 1992). The robust design also allows estimation of parameters for population size, survival rate and recruitment numbers for all periods of the study unlike under Jolly-Seber type models. The major advantage of this design that we emphasize in this short review paper is that it allows separate estimation of immigration and in situ recruitment numbers for a two or more age class model (Nichols and Pollock, 1990). This is contrasted with the age-dependent Jolly-Seber model (Pollock, 1981; Stokes, 1984; Pollock et L, 1990) which provides separate estimates for immigration and in situ recruitment for all but the first two age classes where there is at least a three age class model. The ability to achieve this separation of recruitment components can be very important to population modelers and wildlife managers as many species can only be separated into two easily identified age classes in the field.

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based internet-mediated walking program in veterans with chronic obstructive pulmonary disease

PubMed Central

2014-01-01

Background Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. Methods/Design This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. Discussion Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George’s Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220). Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. Trial registration Clinical Trials.gov NCT01102777

Model Strategies for the Recruitment and Retention of Undergraduate Criminal Justice Students.

ERIC Educational Resources Information Center

Positive Futures, Inc., Washington, DC.

Components for a model strategy/program for the recruitment and retention of students in criminal justice (CJ) programs are presented to stimulate planning activity. These 24 general examples of approaches identify the strategy, state the objectives, provide a rationale, describe implementation, discuss intervention activities, and delineate the…

Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study.

PubMed

Bedke, Jens; Grimm, Marc-Oliver; Grünwald, Viktor

2018-05-01

Renal cell carcinoma (RCC) represents the seventh (men) respectively tenth (women) most frequent cancer in western countries. After one or more lines of VEGF-targeted therapy, immunotherapy with nivolumab is strongly recommended in patients with metastatic RCC. Nivolumab is the first, and so far, only approved PD-1 immune checkpoint inhibitor to demonstrate a gain in overall survival in RCC. We describe herein design and rationale of trial CA209653 ('NIS NORA'), a prospective, noninterventional cohort study investigating the effectiveness of nivolumab. This systematic collection of real-world effectiveness data will recruit 323 patients with advanced RCC to provide a precise estimate for overall survival over a 5-year follow-up period (Trial registration: NCT02940639).

Readiness for diabetes prevention and barriers to lifestyle change in women with a history of gestational diabetes mellitus: rationale and study design.

PubMed

Lipscombe, Lorraine L; Banerjee, Ananya Tina; McTavish, Sarah; Mukerji, Geetha; Lowe, Julia; Ray, Joel; Evans, Marilyn; Feig, Denice S

2014-10-01

Women with gestational diabetes mellitus (GDM) have a high risk of future diabetes, which can be prevented with lifestyle modification. Prior diabetes prevention programmes in this population have been limited by lack of adherence. The aim of this study is to evaluate readiness for behaviour change at different time points after GDM diagnosis and identify barriers and facilitators, to inform a lifestyle modification programme specifically designed for this group. The objective of this paper is to present the rationale and methodological design of this study. The ongoing prospective cohort study has recruited a multi-ethnic cohort of 1353 women with GDM from 7 Ontario, Canada hospitals during their pregnancy. A questionnaire was developed to evaluate stage of readiness for behaviour change, and sociodemographic, psychosocial, and clinical predictors of healthy diet and physical activity. Thus far, 960 women (71%) have completed a baseline survey prior to delivery. Prospective postpartum follow-up is ongoing. We are surveying women at 2 time-points after delivery: 3-12 months postpartum, and 13-24 months postpartum. Survey data will be linked to health care administrative databases for long-term follow-up for diabetes. Qualitative interviews were conducted in a subset of women to gain a deeper understanding of barriers and facilitators to lifestyle change. Our study is a fundamental first step in effectively addressing diabetes prevention in women with GDM. Our findings will aid in the design of a diabetes prevention intervention specifically targeted to women with recent GDM, which can then be evaluated in a clinical trial. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The effects of model composition design choices on high-fidelity simulations of motoneuron recruitment and firing behaviors

NASA Astrophysics Data System (ADS)

Allen, John M.; Elbasiouny, Sherif M.

2018-06-01

Objective. Computational models often require tradeoffs, such as balancing detail with efficiency; yet optimal balance should incorporate sound design features that do not bias the results of the specific scientific question under investigation. The present study examines how model design choices impact simulation results. Approach. We developed a rigorously-validated high-fidelity computational model of the spinal motoneuron pool to study three long-standing model design practices which have yet to be examined for their impact on motoneuron recruitment, firing rate, and force simulations. The practices examined were the use of: (1) generic cell models to simulate different motoneuron types, (2) discrete property ranges for different motoneuron types, and (3) biological homogeneity of cell properties within motoneuron types. Main results. Our results show that each of these practices accentuates conditions of motoneuron recruitment based on the size principle, and minimizes conditions of mixed and reversed recruitment orders, which have been observed in animal and human recordings. Specifically, strict motoneuron orderly size recruitment occurs, but in a compressed range, after which mixed and reverse motoneuron recruitment occurs due to the overlap in electrical properties of different motoneuron types. Additionally, these practices underestimate the motoneuron firing rates and force data simulated by existing models. Significance. Our results indicate that current modeling practices increase conditions of motoneuron recruitment based on the size principle, and decrease conditions of mixed and reversed recruitment order, which, in turn, impacts the predictions made by existing models on motoneuron recruitment, firing rate, and force. Additionally, mixed and reverse motoneuron recruitment generated higher muscle force than orderly size motoneuron recruitment in these simulations and represents one potential scheme to increase muscle efficiency. The examined model

The effects of model composition design choices on high-fidelity simulations of motoneuron recruitment and firing behaviors.

PubMed

Allen, John M; Elbasiouny, Sherif M

2018-06-01

Computational models often require tradeoffs, such as balancing detail with efficiency; yet optimal balance should incorporate sound design features that do not bias the results of the specific scientific question under investigation. The present study examines how model design choices impact simulation results. We developed a rigorously-validated high-fidelity computational model of the spinal motoneuron pool to study three long-standing model design practices which have yet to be examined for their impact on motoneuron recruitment, firing rate, and force simulations. The practices examined were the use of: (1) generic cell models to simulate different motoneuron types, (2) discrete property ranges for different motoneuron types, and (3) biological homogeneity of cell properties within motoneuron types. Our results show that each of these practices accentuates conditions of motoneuron recruitment based on the size principle, and minimizes conditions of mixed and reversed recruitment orders, which have been observed in animal and human recordings. Specifically, strict motoneuron orderly size recruitment occurs, but in a compressed range, after which mixed and reverse motoneuron recruitment occurs due to the overlap in electrical properties of different motoneuron types. Additionally, these practices underestimate the motoneuron firing rates and force data simulated by existing models. Our results indicate that current modeling practices increase conditions of motoneuron recruitment based on the size principle, and decrease conditions of mixed and reversed recruitment order, which, in turn, impacts the predictions made by existing models on motoneuron recruitment, firing rate, and force. Additionally, mixed and reverse motoneuron recruitment generated higher muscle force than orderly size motoneuron recruitment in these simulations and represents one potential scheme to increase muscle efficiency. The examined model design practices, as well as the present results

Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture.

PubMed

Rua, Tiago; Vijayanathan, Sanjay; Parkin, David; Goh, Vicky; McCrone, Paul; Gidwani, Sam

2018-04-01

Background Wrist injury is a common presentation to the Emergency Department in the United Kingdom. Among these injuries, the scaphoid is the most common fractured carpal bone. However, given the limited ability of conventional radiography to accurately diagnose a suspected scaphoid fracture on presentation, its diagnosis and management remain challenging. Despite the vast clinical evidence supporting the superior accuracy of magnetic resonance imaging, there is little to no evidence around the real-world clinical and economic impact of immediate magnetic resonance imaging in the management of suspected scaphoid fractures. Methods Review of design and implementation challenges associated with the identification and subsequent recruitment of eligible patients, implementation of a novel clinical pathway in an acute setting, rationale behind the primary and secondary outcomes selected and measurement of the primary outcome. Results The Scaphoid Magnetic Resonance Imaging in Trauma trial is a single-site prospective, randomised, non-blinded, parallel design trial that aims to evaluate the use of immediate magnetic resonance imaging in the management of patients presenting to the acute setting with suspected scaphoid fractures. The primary outcome is the total 3-month cost per patient associated with the diagnosis and treatment of suspected scaphoid fractures. It is hypothesised that the immediate use of magnetic resonance imaging, a more accurate but expensive imaging modality, in patients with negative findings in the initial four-view radiography, will reduce the overall National Health Service costs by promoting definitive care and avoiding unnecessary diagnostic and treatment procedures. Other rationale design considerations in the recruitment, randomisation, data acquisition and intervention implementation are also discussed. Several of these challenges derive from real-world operational issues associated with the provision of magnetic resonance imaging in an

Pharmacogenetic study of second-generation antipsychotic long-term treatment metabolic side effects (the SLiM Study): rationale, objectives, design and sample description.

PubMed

Pina-Camacho, Laura; Díaz-Caneja, Covadonga M; Saiz, Pilar A; Bobes, Julio; Corripio, Iluminada; Grasa, Eva; Rodriguez-Jimenez, Roberto; Fernández, Miryam; Sanjuán, Julio; García-López, Aurelio; Tapia-Casellas, Cecilia; Álvarez-Blázquez, María; Fraguas, David; Mitjans, Marina; Arias, Bárbara; Arango, Celso

2014-01-01

Weight gain is an important and common side effect of second generation antipsychotics (SGAs). Furthermore, these drugs can induce other side effects associated with higher cardiovascular morbidity and mortality, such as insulin resistance, diabetes or metabolic syndrome. Preliminary studies show that inter-individual genetic differences produce varying degrees of vulnerability to the different SGA-induced side effects. The Second-generation antipsychotic Long-term treatment Metabolic side effects (SLiM) study aims to identify clinical, environmental and genetic factors that explain inter-individual differences in weight gain and metabolic changes in drug-naïve patients after six months of treatment with SGAs. The SLIM study is a multicenter, observational, six-month pharmacogenetic study where a cohort of 307 drug-naïve paediatric and adult patients (age range 8.8-90.1 years) and a cohort of 150 age- and sex- matched healthy controls (7.8-73.2 years) were recruited. This paper describes the rationale, objectives and design of the study and provides a description of the sample at baseline. Results from the SLiM study will provide a better understanding of the clinical, environmental, and genetic factors involved in weight gain and metabolic disturbances associated with SGA treatment. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

Twins Eye Study in Tasmania (TEST): Rationale and Methodology to Recruit and Examine Twins

PubMed Central

Mackey, David A; MacKinnon, Jane R; Brown, Shayne A; Kearns, Lisa S; Ruddle, Jonathan B; Sanfilippo, Paul G; Sun, Cong; Hammond, Christopher J; Young, Terri L; Martin, Nicholas G; Hewitt, Alex W

2013-01-01

Visual impairment is a leading cause for morbidity and poor quality of life in our community. Unravelling the mechanisms underpinning important blinding diseases could allow for preventative or curative steps to be implemented. Twin siblings provide a unique opportunity in biology to discover genes associated with numerous eye diseases and ocular biometry. Twins are particularly useful for quantitative trait analysis through genome-wide association and linkage studies. Although many studies involving twins rely on twin registries, we present our approach to the Twins Eye Study in Tasmania to provide insight into possible recruitment strategies, expected participation rates and potential examination strategies that can be considered by other researchers for similar studies. Five separate avenues for cohort recruitment were adopted: 1) piggy-backing existing studies where twins had been recruited; 2); utilising the national twin registry; 3) word of mouth and local media publicity; 4) directly approaching schools; and finally 5) collaborating with other research groups studying twins. PMID:19803772

Rationale and study design of the Japan environment and children’s study (JECS)

PubMed Central

2014-01-01

Background There is global concern over significant threats from a wide variety of environmental hazards to which children face. Large-scale and long-term birth cohort studies are needed for better environmental management based on sound science. The primary objective of the Japan Environment and Children’s Study (JECS), a nation-wide birth cohort study that started its recruitment in January 2011, is to elucidate environmental factors that affect children’s health and development. Methods/Design Approximately 100,000 expecting mothers who live in designated study areas will be recruited over a 3-year period from January 2011. Participating children will be followed until they reach 13 years of age. Exposure to environmental factors will be assessed by chemical analyses of bio-specimens (blood, cord blood, urine, breast milk, and hair), household environment measurements, and computational simulations using monitoring data (e.g. ambient air quality monitoring) as well as questionnaires. JECS’ priority outcomes include reproduction/pregnancy complications, congenital anomalies, neuropsychiatric disorders, immune system disorders, and metabolic/endocrine system disorders. Genetic factors, socioeconomic status, and lifestyle factors will also be examined as covariates and potential confounders. To maximize representativeness, we adopted provider-mediated community-based recruitment. Discussion Through JECS, chemical substances to which children are exposed during the fetal stage or early childhood will be identified. The JECS results will be translated to better risk assessment and management to provide healthy environment for next generations. PMID:24410977

The Lifeways Cross-Generation Study: design, recruitment and data management considerations.

PubMed

O'Mahony, D; Fallon, U B; Hannon, F; Kloeckner, K; Avalos, G; Murphy, A W; Kelleher, C C

2007-09-01

The Lifeways Cross-Generation Cohort Study was first established in 2001 and is a unique longitudinal database in Ireland, with currently over three and a half thousand family participants derived from 1124 mothers recruited initially during pregnancy, mainly during 2002. The database comprises a) baseline self-reported health data for all mothers, a third of fathers and at least one grandparent b) clinical hospital data at recruitment, c) three year follow-up data from the families' General Practitioners, and d) linkage to hospital and vaccination databases. Data collection for the five-year follow-up with parents is underway, continuing through 2007. Because there is at present no single national/regional health information system in Ireland, original data instruments were designed to capture data directly from family members and through their hospitals and healthcare providers. A system of relational databases was designed to coordinate data capture for a complex array of study instruments and to facilitate tracking of family members at different time points.

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.

Holonic Rationale and Bio-inspiration on Design of Complex Emergent and Evolvable Systems

NASA Astrophysics Data System (ADS)

Leitao, Paulo

Traditional centralized and rigid control structures are becoming inflexible to face the requirements of reconfigurability, responsiveness and robustness, imposed by customer demands in the current global economy. The Holonic Manufacturing Systems (HMS) paradigm, which was pointed out as a suitable solution to face these requirements, translates the concepts inherited from social organizations and biology to the manufacturing world. It offers an alternative way of designing adaptive systems where the traditional centralized control is replaced by decentralization over distributed and autonomous entities organized in hierarchical structures formed by intermediate stable forms. In spite of its enormous potential, methods regarding the self-adaptation and self-organization of complex systems are still missing. This paper discusses how the insights from biology in connection with new fields of computer science can be useful to enhance the holonic design aiming to achieve more self-adaptive and evolvable systems. Special attention is devoted to the discussion of emergent behavior and self-organization concepts, and the way they can be combined with the holonic rationale.

Reducing alcohol consumption among university students: recruitment and program design strategies based on Social Marketing Theory.

PubMed

Black, D R; Smith, M A

1994-09-01

Recruitment of program participants and development of appealing comprehensive alcohol abuse prevention programs is an exigent priority for university campuses due to the serious physical and emotional consequences related to alcohol consumption. A sample of 67 students from a large midwestern university completed a survey based on Social Marketing Theory (SMT) which was developed to improve recruitment and enhance the design of comprehensive alcohol abuse prevention programs. The results indicate that recruitment may be optimized by providing a flexible, convenient, low-cost program that encourages friends' participation, communicates alcohol-related risks and offers university credit or refund as participation incentives. The design of alcohol abuse prevention programs may be enhanced by emphasizing the positive outcomes of reducing alcohol consumption, improving the quality and quantity of alternatives to the social atmosphere connected with drinking, and soliciting respected opinion leaders (physicians and parents) to communicate alcohol reduction messages. This project is a first initiative to 'fill the gap' in the social marketing research literature by providing formative information pertinent to recruitment and design of alcohol reduction programs specifically for college students.

A Qualitative Study of Motivations for Minority Recruitment in Cancer Clinical Trials Across Five NCI-Designated Cancer Centers.

PubMed

Simoni, Zachary R; Martin, Michelle; Wenzel, Jennifer A; Cook, Elise D; Konety, Badrinath; Vickers, Selwyn M; Chen, Moon S; Foaud, Mona N; Durant, Raegan W

2016-11-08

Minority enrollment in cancer clinical trials is traditionally low. In light of this fact, numerous studies have investigated barriers to recruitment and retention within minority populations. However, very little research has investigated the importance of clinicians' and researchers' motivations for minority recruitment in cancer clinical trials. Therefore, we sought to examine motivations for minority recruitment across four professional stakeholder groups (principal investigators, clinicians, research staff, and Cancer Center leaders) at five National Cancer Institute (NCI)-designated Comprehensive Cancer Centers. This study is based on the data from 91 qualitative interviews conducted across the five NCI-designated Comprehensive Cancer Centers to investigate stakeholders' motivations for minority recruitment in cancer clinical trials. Emergent themes include (a) minority recruitment increases generalizability of cancer clinical trials, (b) minority recruitment is motivated by social justice, (c) some institutions promote minority recruitment through the use of supplemental financial support, (d) federal funding requirements for minority inclusion in clinical research motivate investigators to focus on minority recruitment, and (e) some stakeholders favor a more race-neutral approach to participant recruitment rather than an emphasis on targeted minority recruitment. The perspectives of clinical and research stakeholders potentially inform the assessment of existing strategies and the development of new strategies to increase motivation for minority recruitment in cancer clinical trials.

Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in Argentina.

PubMed

Mills, Katherine T; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A; He, Jiang

2014-08-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This article summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure [BP], health education for medication adherence and lifestyle modification) conducted by community health workers and a mobile health intervention. The primary outcome is net change in systolic BP from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic BP, BP control and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries.

Rationale and study design of the Japan environment and children's study (JECS).

PubMed

Kawamoto, Toshihiro; Nitta, Hiroshi; Murata, Katsuyuki; Toda, Eisaku; Tsukamoto, Naoya; Hasegawa, Manabu; Yamagata, Zentaro; Kayama, Fujio; Kishi, Reiko; Ohya, Yukihiro; Saito, Hirohisa; Sago, Haruhiko; Okuyama, Makiko; Ogata, Tsutomu; Yokoya, Susumu; Koresawa, Yuji; Shibata, Yasuyuki; Nakayama, Shoji; Michikawa, Takehiro; Takeuchi, Ayano; Satoh, Hiroshi

2014-01-10

There is global concern over significant threats from a wide variety of environmental hazards to which children face. Large-scale and long-term birth cohort studies are needed for better environmental management based on sound science. The primary objective of the Japan Environment and Children's Study (JECS), a nation-wide birth cohort study that started its recruitment in January 2011, is to elucidate environmental factors that affect children's health and development. Approximately 100,000 expecting mothers who live in designated study areas will be recruited over a 3-year period from January 2011. Participating children will be followed until they reach 13 years of age. Exposure to environmental factors will be assessed by chemical analyses of bio-specimens (blood, cord blood, urine, breast milk, and hair), household environment measurements, and computational simulations using monitoring data (e.g. ambient air quality monitoring) as well as questionnaires. JECS' priority outcomes include reproduction/pregnancy complications, congenital anomalies, neuropsychiatric disorders, immune system disorders, and metabolic/endocrine system disorders. Genetic factors, socioeconomic status, and lifestyle factors will also be examined as covariates and potential confounders. To maximize representativeness, we adopted provider-mediated community-based recruitment. Through JECS, chemical substances to which children are exposed during the fetal stage or early childhood will be identified. The JECS results will be translated to better risk assessment and management to provide healthy environment for next generations.

The Female Athlete Body (FAB) study: Rationale, design, and baseline characteristics.

PubMed

Stewart, Tiffany M; Pollard, Tarryn; Hildebrandt, Tom; Beyl, Robbie; Wesley, Nicole; Kilpela, Lisa Smith; Becker, Carolyn Black

2017-09-01

Eating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers. This paper describes the design, intervention, and participant baseline characteristics. Future papers will discuss outcomes. Female collegiate athletes (N=481) aged 17-21 were randomized by site, team, and sport type to either FAB or a waitlist control group. FAB consisted of three sessions (1.3h each) of a behavioral ED prevention program. Assessments were conducted at baseline (pre-intervention), post-intervention (3weeks), and six-, 12-, and 18-month follow-ups. This study achieved 96% (N=481) of target recruitment (N=500). Few group differences emerged at baseline. Total sample analyses revealed moderately low baseline instances of ED symptoms and clinical cases. Health risks associated with EDs necessitate interventions for female athletes. The FAB study is the largest existing RCT for female athletes aimed at both reduction of ED risk factors and ED prevention. The methods presented and population recruited for this study represent an ideal intervention for assessing the effects of FAB on both the aforementioned outcomes. We anticipate that findings of this study (reported in future papers) will make a significant contribution to the ED risk factor reduction and prevention literature. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of Providing a Rationale for Learning a Lesson on Students' Motivation and Learning in Online Learning Environments

ERIC Educational Resources Information Center

Shin, Tae Seob

2010-01-01

This study examined whether providing a rationale for learning a particular lesson influences students' motivation and learning in online learning environments. A mixed-method design was used to investigate the effects of two types of rationales (former student vs. instructor rationales) presented in an online introductory educational psychology…

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus.

PubMed

Nobels, Frank; Debacker, Noëmi; Brotons, Carlos; Elisaf, Moses; Hermans, Michel P; Michel, Georges; Muls, Erik

2011-09-22

To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Recruitment was completed in December 2008 with 3994 evaluable patients. This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. NCT00681850.

Rationales for Commonly "Challenged" Taught Books.

ERIC Educational Resources Information Center

Shugert, Diane P., Ed.; And Others

1983-01-01

Intended for teachers, this focused journal issue contains separate rationales for teaching books that have been challenged as appropriate instructional materials. Following a discussion of the purpose for rationales and suggestions for using them, the journal presents rationales for teaching the following books: "To Kill a Mockingbird,""The Diary…

Design Rationale Behind the Serious Self-Regulation Game Intervention "Balance It": Overweight Prevention Among Secondary Vocational Education Students in The Netherlands.

PubMed

Spook, Jorinde E; Paulussen, Theo; Paulissen, Rosie; Visschedijk, Gillian; Kok, Gerjo; van Empelen, Pepijn

2015-10-01

This article describes the design rationale behind a serious self-regulation game intervention. The aim of the game is to promote healthy dietary intake and physical activity among secondary vocational educational students in The Netherlands (approximately 16-20 years of age). The game "Balance It" was developed according to an intervention mapping (IM) protocol. Following IM, we specified health promotion and usability objectives and linked these objectives to selected behavior change and persuasive methods. Accordingly, these methods were translated into a coherent intervention program. The health behavior change objectives were derived from the determinants of the behavior and from Self-Regulation Theory (e.g., students are asked to set goals, monitor and evaluate their behavior, and create coping plans). Usability objectives were derived from the RE-AIM model (i.e., Reach, Effectiveness, Adoption, Implementation, and Maintenance). Next, behavior change and persuasive techniques were selected (e.g., goal setting and prompting, respectively) that did fit with the targeted change objectives and were translated in the design of a (mobile) serious self-regulation game intervention. Subsequently, three concept and usability tests were performed to improve intervention usability, and an evaluation plan was developed. The aim of this study was to provide a design rationale for game interventions targeting health-related behaviors. We developed a coherent program design in which both health behavior change and usability factors are addressed. The IM protocol can serve as a useful guide for decision making in program development and evaluation.

Treatment of early-onset schizophrenia spectrum disorders (TEOSS): rationale, design, and methods.

PubMed

McClellan, Jon; Sikich, Linmarie; Findling, Robert L; Frazier, Jean A; Vitiello, Benedetto; Hlastala, Stefanie A; Williams, Emily; Ambler, Denisse; Hunt-Harrison, Tyehimba; Maloney, Ann E; Ritz, Louise; Anderson, Robert; Hamer, Robert M; Lieberman, Jeffrey A

2007-08-01

The Treatment of Early Onset Schizophrenia Spectrum Disorders Study is a publicly funded clinical trial designed to compare the therapeutic benefits, safety, and tolerability of risperidone, olanzapine, and molindone in youths with early-onset schizophrenia spectrum disorders. The rationale, design, and methods of the Treatment of Early Onset Schizophrenia Spectrum Disorders Study are described. Using a randomized, double-blind, parallel-group design at four sites, youths with EOSS (ages 8-19 years) were assigned to an 8-week acute trial of risperidone (0.5-6.0 mg/day), olanzapine (2.5-20 mg/day), or molindone (10-140 mg/day). Responders continued double-blind treatment for 44 weeks. The primary outcome measure was responder status at 8 weeks, defined by a 20% reduction in baseline Positive and Negative Symptom Scale scores plus ratings of significant improvement on the Clinical Global Impressions. Secondary outcome measures included assessments of psychopathology, functional impairment, quality of life, and medication safety. An intent-to-treat analytic plan was used. From February 2002 to May 2006, 476 youths were screened, 173 were further evaluated, and 119 were randomized. Several significant study modifications were required to address safety, the use of adjunctive medications, and the termination of the olanzapine treatment arm due to weight gain. The Treatment of Early Onset Schizophrenia Spectrum Disorders Study will inform clinical practice regarding the use of antipsychotic medications for youths with early-onset schizophrenia spectrum disorders. Important safety concerns emerged during the study, including higher than anticipated rates of suicidality and problems tapering thymoleptic agents before randomization.

Rationale of Early Adopters of Fossil Fuel Divestment

ERIC Educational Resources Information Center

Beer, Christopher Todd

2016-01-01

Purpose: This research uses the social science perspectives of institutions, ecological modernization and social movements to analyze the rationale used by the early-adopting universities of fossil fuel divestment in the USA. Design/methodology/approach: Through analysis of qualitative data from interviews with key actors at the universities that…

The Mediterranean healthy eating, ageing, and lifestyle (MEAL) study: rationale and study design.

PubMed

Grosso, Giuseppe; Marventano, Stefano; D'Urso, Maurizio; Mistretta, Antonio; Galvano, Fabio

2017-08-01

There is accumulating evidence suggesting that Mediterranean lifestyles, including nutrition and sleeping patterns as well as social integration, may play a role in reducing age-related diseases. However, the literature is mostly deficient of evidence provided by Italian Mediterranean islands that more closely adhered to the originally described lifestyles. In this paper, we described the rationale and the study design of the Mediterranean healthy Eating, Ageing, and Lifestyle (MEAL) study, a prospective population-based cohort established in Sicily, southern Italy. The main exposures investigated are classical determinants of health, including demographic, nutritional habits, smoking and physical activity status, as well as eating-related behaviors, sleeping habits, sun exposure, social resources, and perceived stress. Anthropometric measurements will be collected. The main outcomes included depression, quality of life, and, after the follow-up period, also cardiovascular disease and cancer. The MEAL study may provide important data to increase our knowledge regarding the prevalence, incidence, and risk factors of age-related disorders in the Mediterranean region.

Oral Health Promotion in Schools: Rationale and Evaluation

ERIC Educational Resources Information Center

Kizito, Alex; Caitlin, Meredith; Wang, Yili; Kasangaki, Arabat; Macnab, Andrew J.

2014-01-01

Purpose: The purpose of this paper is to explain the rationale and potential for the WHO health promoting schools (HPS) to improve children's oral health, and describe validated quantitative methodologies and qualitative approaches to measure program impact. Design/Methodology/Approach: Critical discussion of the impact of poor oral health and…

Stillbirth Collaborative Research Network: design, methods and recruitment experience.

PubMed

Parker, Corette B; Hogue, Carol J R; Koch, Matthew A; Willinger, Marian; Reddy, Uma M; Thorsten, Vanessa R; Dudley, Donald J; Silver, Robert M; Coustan, Donald; Saade, George R; Conway, Deborah; Varner, Michael W; Stoll, Barbara; Pinar, Halit; Bukowski, Radek; Carpenter, Marshall; Goldenberg, Robert

2011-09-01

The Stillbirth Collaborative Research Network (SCRN) has conducted a multisite, population-based, case-control study, with prospective enrollment of stillbirths and livebirths at the time of delivery. This paper describes the general design, methods and recruitment experience. The SCRN attempted to enroll all stillbirths and a representative sample of livebirths occurring to residents of pre-defined geographical catchment areas delivering at 59 hospitals associated with five clinical sites. Livebirths <32 weeks gestation and women of African descent were oversampled. The recruitment hospitals were chosen to ensure access to at least 90% of all stillbirths and livebirths to residents of the catchment areas. Participants underwent a standardised protocol including maternal interview, medical record abstraction, placental pathology, biospecimen testing and, in stillbirths, post-mortem examination. Recruitment began in March 2006 and was completed in September 2008 with 663 women with a stillbirth and 1932 women with a livebirth enrolled, representing 69% and 63%, respectively, of the women identified. Additional surveillance for stillbirths continued until June 2009 and a follow-up of the case-control study participants was completed in December 2009. Among consenting women, there were high consent rates for the various study components. For the women with stillbirths, 95% agreed to a maternal interview, chart abstraction and a placental pathological examination; 91% of the women with a livebirth agreed to all of these components. Additionally, 84% of the women with stillbirths agreed to a fetal post-mortem examination. This comprehensive study is poised to systematically study a wide range of potential causes of, and risk factors for, stillbirths and to better understand the scope and incidence of the problem. © 2011 Blackwell Publishing Ltd.

A workplace email-linked website intervention for modifying cancer-related dietary and lifestyle risk factors: rationale, design and baseline findings.

PubMed

Ang, Y K; Mirnalini, K; Zalilah, M S

2013-04-01

The use of email and website as channels for workplace health information delivery is not fully explored. This study aims to describe the rationale, design, and baseline findings of an email-linked website intervention to improve modifiable cancer risk factors. Employees of a Malaysian public university were recruited by systematic random sampling and randomised into an intervention (n = 174) or control group (n = 165). A website was developed for the intervention and educational modules were uploaded onto the website. The intervention group received ten consecutive weekly emails with hypertext links to the website for downloading the modules and two individual phone calls as motivational support whilst the control group received none. Diet, lifestyle, anthropometric measurements, psychosocial factors and stages of change related to dietary fat, fruit and vegetable intake, and physical activity were assessed. Participants were predominantly female and in non-academic positions. Obesity was prevalent in 15% and 37% were at risk of co-morbidities. Mean intake of fats was 31%, fruit was -1 serving/day and vegetable was < 1 serving/day. Less than 20% smoked and drank alcohol and about 40% were physically inactive. The majority of the participants fell into the Preparation stage for decreasing fat intake, eating more fruit and vegetables, and increasing physical activity. Self-efficacy and perceived benefits were lowest among participants in the Precontemplation/Contemplation stage compared to the Preparation and Action/Maintenance stages. Baseline data show that dietary and lifestyle practices among the employees did not meet the international guidelines for cancer prevention. Hence the findings warrant the intervention planned.

Rationale and design for the Predictors of Arrhythmic and Cardiovascular Risk in End Stage Renal Disease (PACE) study.

PubMed

Parekh, Rulan S; Meoni, Lucy A; Jaar, Bernard G; Sozio, Stephen M; Shafi, Tariq; Tomaselli, Gordon F; Lima, Joao A; Tereshchenko, Larisa G; Estrella, Michelle M; Kao, W H Linda

2015-04-24

Sudden cardiac death occurs commonly in the end-stage renal disease population receiving dialysis, with 25% dying of sudden cardiac death over 5 years. Despite this high risk, surprisingly few prospective studies have studied clinical- and dialysis-related risk factors for sudden cardiac death and arrhythmic precursors of sudden cardiac death in end-stage renal disease. We present a brief summary of the risk factors for arrhythmias and sudden cardiac death in persons with end-stage renal disease as the rationale for the Predictors of Arrhythmic and Cardiovascular Risk in End Stage Renal Disease (PACE) study, a prospective cohort study of patients recently initiated on chronic hemodialysis, with the overall goal to understand arrhythmic and sudden cardiac death risk. Participants were screened for eligibility and excluded if they already had a pacemaker or an automatic implantable cardioverter defibrillator. We describe the study aims, design, and data collection of 574 incident hemodialysis participants from the Baltimore region in Maryland, U.S.A.. Participants were recruited from 27 hemodialysis units and underwent detailed clinical, dialysis and cardiovascular evaluation at baseline and follow-up. Cardiovascular phenotyping was conducted on nondialysis days with signal averaged electrocardiogram, echocardiogram, pulse wave velocity, ankle, brachial index, and cardiac computed tomography and angiography conducted at baseline. Participants were followed annually with study visits including electrocardiogram, pulse wave velocity, and ankle brachial index up to 4 years. A biorepository of serum, plasma, DNA, RNA, and nails were collected to study genetic and serologic factors associated with disease. Studies of modifiable risk factors for sudden cardiac death will help set the stage for clinical trials to test therapies to prevent sudden cardiac death in this high-risk population.

So you think you've designed an effective recruitment protocol?

PubMed

Green, Cara; Vandall-Walker, Virginia

2017-03-22

Background Recruiting acutely ill patients to participate in research can be challenging. This paper outlines the difficulties the first author encountered in a study and the steps she took to overcome problems with research ethics, gain access to participants and implement a recruitment protocol in multiple hospitals. It also compares these steps with literature related to recruitment. Aim To inform and inspire neophyte researchers about the need for planning and resilience when dealing with recruitment challenges in multiple hospitals. Discussion The multiple enablers and barriers to the successful implementation of a hospital-based study recruitment protocol are explored based on a neophyte researcher's optimistic assumptions about this stage of the study. Conclusions Perseverance, adequately planning for contingencies, and accepting the barriers and challenges to recruitment are essential for completing one's research study and ensuring fulfilment as a researcher. Implications for practice Healthcare students carrying out research require adequate knowledge about conducting hospital-based, patient research to inform their recruitment plan. Maximising control over recruitment, allowing for adequate time to conduct data collection, and maintaining a good work ethic will help to ensure success.

The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT)

PubMed Central

2010-01-01

Background Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum) till one year (maximum) will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy), also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE) and functional status (Neck Disability Index (NDI-DV)). Secondary outcomes are neck pain (Numeric Rating Scale (NRS)), Eurocol, costs and quality of life (SF36). Discussion This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration ClinicalTrials.gov Identifier: NCT00713843 PMID:20096136

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

PubMed Central

2011-01-01

Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

Recruiting Black Americans in a Large Cohort Study: The Adventist Health Study-2 (AHS-2) Design, Methods and Participant Characteristics

PubMed Central

Herring, R. Patti; Butler, Terry; Hall, Sonja; Montgomery, Susanne B.; Fraser, Gary E.

2011-01-01

Objective The goal of the prospective Adventist Health Study-2 (AHS-2) was to examine the relationship between diet and risk of breast, prostate and colon cancers in Black and White participants. This paper describes the study design, recruitment methods, response rates, and characteristics of Blacks in the AHS-2, thus providing insights about effective strategies to recruit Blacks to participate in research studies. Design We designed a church-based recruitment model and trained local recruiters who used various strategies to recruit participants in their churches. Participants completed a 50-page self-administered dietary and lifestyle questionnaire. Participants Participants are Black Seventh-day Adventists, aged 30–109 years, and members of 1,209 Black churches throughout the United States and Canada. Results Approximately 48,328 Blacks from an estimated target group of over 90,000 signed up for the study and 25,087 completed the questionnaire, comprising about 26% of the larger 97,000 AHS-2-member cohort. Participants were diverse in age, geographic location, education, and income. Seventy percent were female with a median age of 59 years. Conclusion In spite of many recruitment challenges and barriers, we successfully recruited a large cohort whose data should provide some answers as to why Blacks have poorer health outcomes than several other ethnic groups, and help explain existing health disparities. PMID:21305834

Comprehensive Approach for Hypertension Control in Low-income Populations: Rationale and Study Design for the Hypertension Control Program in Argentina (HCPIA)

PubMed Central

Mills, Katherine T.; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A.; He, Jiang

2014-01-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This paper summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure, health education for medication adherence and lifestyle modification) conducted by community health workers, and a mobile health intervention. The primary outcome is net change in systolic blood pressure from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic blood pressure, blood pressure control, and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical, and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries. PMID:24978148

The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer.

PubMed

Hamilton, D W; de Salis, I; Donovan, J L; Birchall, M

2013-08-01

We aimed to investigate the factors contributing to poor recruitment to the EaStER trial "Early Stage glottic cancer: Endoscopic excision or Radiotherapy" feasibility study. We performed a prospective qualitative assessment of the EaStER trial at three centres to investigate barriers to recruitment and implement changes. Methods used included semi-structured interviews, focus groups and audio-recordings of recruitment encounters. First, surgeons and recruiters did not all accept the primary outcome as the rationale for the trial. Surgeons did not always adhere to the trial eligibility criteria leading to variations between centres in the numbers of "eligible" patients. Second, as both treatments were considered equally successful, recruiters and patients focused on the pragmatics of the different trial arms, favouring surgery over radiotherapy. The lack of equipoise was reflected in the way recruiters presented trial information. Third, patient views, beliefs and preferences were not fully elicited or addressed by recruiters. Fourth, in some centres, logistical issues made trial participation difficult. This qualitative research identified several major issues that explained recruitment difficulties. While there was insufficient time to address these in the EaStER trial, several factors would need to be addressed to launch further RCTs in head and neck cancer. These include the need for clear ongoing agreement among recruiting clinicians regarding details in the study protocol; an understanding of the logistical issues hindering recruitment at individual centres; and training recruiters to enable them to explain the need for randomisation and the rationale for the RCT to patients.

Recruit--An Ontology Based Information Retrieval System for Clinical Trials Recruitment.

PubMed

Patrão, Diogo F C; Oleynik, Michel; Massicano, Felipe; Morassi Sasso, Ariane

2015-01-01

Clinical trials are studies designed to assess whether a new intervention is better than the current alternatives. However, most of them fail to recruit participants on schedule. It is hard to use Electronic Health Record (EHR) data to find eligible patients, therefore studies rely on manual assessment, which is time consuming, inefficient and requires specialized training. In this work we describe the design and development of an information retrieval system with the objective of finding eligible patients for cancer trials. The Recruit system has been in use at A. C. Camargo Cancer Center since August/2014 and contains data from more than 500,000 patients and 9 databases. It uses ontologies to integrate data from several sources and represent medical knowledge, which helps enhance results. One can search both in structured data and inside free text reports. The preliminary quality assessments shows excellent recall rates. Recruit proved to be an useful tool for researchers and its modular design could be applied to other clinical conditions and hospitals.

Design and Rationale for a Parent-Led Intervention to Increase Fruit and Vegetable Intake in Young Childhood Cancer Survivors (Reboot): Protocol for a Pilot Study

PubMed Central

Cohen, Jennifer; Wakefield, Claire; Grech, Allison; Garnett, Sarah; Gohil, Paayal; Cohn, Richard

2018-01-01

Background Poor dietary habits are common among childhood cancer survivors, despite increasing their risk of cardio metabolic complications after cancer treatment. Here, we describe the design and rationale for a pilot telephone-based, parent-led intervention aimed at increasing fruit and vegetable intake in young cancer survivors (Reboot). Objective This pilot study aims to assess the feasibility and acceptability of delivering evidence-based telephone support to parents of childhood cancer survivors. A secondary aim includes assessing the effect of Reboot on improving childhood cancer survivors’ dietary quality by increasing child fruit and vegetable intake and variety and its contribution to overall nutrient intake. Methods We aim to recruit parents of 15 young cancer survivors aged 2 to 12 years who have completed cancer treatment less than five years ago. The intervention comprises of 4 weekly 45-minute telephone sessions led by a health professional and one booster session 6 weeks later. Sessions address the effects of cancer treatment on children’s diets, recommended fruit and vegetable intake for children, and evidence-based strategies to promote the consumption of fruit and vegetables as well as to manage fussy eating. Results Reboot is based on an existing, evidence-based parent nutrition intervention and modified for childhood cancer survivors following extensive collaboration with experts in the field. Primary outcomes of feasibility and acceptability will be measured by the number of participants who complete all five sessions, average session length (minutes), length between sessions (days) and parent Likert ratings of the usefulness and impact of the intervention collected after the booster session. Of the 15 participants we aim to recruit, 3 have completed the intervention, 1 declined to participate, 11 are actively completing the intervention and 2 participants are providing written consent. The remaining 3 participants will be recruited via

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

Corporate incentives for promoting safety belt use : rationale, guidelines, and examples

DOT National Transportation Integrated Search

1982-10-01

This manual was designed to teach the corporate executive successful strategies for implementing and evaluating a successful industry-based program to motivate employee safety belt use. A rationale is given for the general approach; and specific guid...

Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

PubMed Central

FRIEDMANN, PETER D.; KATZ, ELIZABETH C.; RHODES, ANNE G.; TAXMAN, FAYE S.; O'CONNELL, DANIEL J.; FRISMAN, LINDA K.; BURDON, WILLIAM M.; FLETCHER, BENNETT W.; LITT, MARK D.; CLARKE, JENNIFER; MARTIN, STEVEN S.

2009-01-01

This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment counselors to provide role induction counseling, contract for pro-social behavior, and deliver contingent reinforcement of behaviors consistent with treatment objectives. The Step'n Out study will randomize 450 drug-involved parolees to collaborative behavioral management or usual parole. Follow-up at 3-and 9-months will assess primary outcomes of rearrest, crime and drug use. If collaborative behavioral management is effective, its wider adoption could improve the outcomes of community reentry of drug-involved ex-offenders. PMID:19809591

Building confidence in quantitative systems pharmacology models: An engineer's guide to exploring the rationale in model design and development.

PubMed

Timmis, J; Alden, K; Andrews, P; Clark, E; Nellis, A; Naylor, B; Coles, M; Kaye, P

2017-03-01

This tutorial promotes good practice for exploring the rationale of systems pharmacology models. A safety systems engineering inspired notation approach provides much needed rigor and transparency in development and application of models for therapeutic discovery and design of intervention strategies. Structured arguments over a model's development, underpinning biological knowledge, and analyses of model behaviors are constructed to determine the confidence that a model is fit for the purpose for which it will be applied. © 2016 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Recruiting black Americans in a large cohort study: the Adventist Health Study-2 (AHS-2) design, methods and participant characteristics.

PubMed

Herring, R Patti; Butler, Terry; Hall, Sonja; Montgomery, Susanne B; Fraser, Gary E

2010-01-01

The goal of the prospective Adventist Health Study-2 (AHS-2) was to examine the relationship between diet and risk of breast, prostate and colon cancers in Black and White participants. This paper describes the study design, recruitment methods, response rates, and characteristics of Blacks in the AHS-2, thus providing insights about effective strategies to recruit Blacks to participate in research studies. We designed a church-based recruitment model and trained local recruiters who used various strategies to recruit participants in their churches. Participants completed a 50-page self-administered dietary and lifestyle questionnaire. Participants are Black Seventh-day Adventists, aged 30-109 years, and members of 1,209 Black churches throughout the United States and Canada. Approximately 48,328 Blacks from an estimated target group of over 90,000 signed up for the study and 25,087 completed the questionnaire, comprising about 26% of the larger 97,000 AHS-2-member cohort. Participants were diverse in age, geographic location, education, and income. Seventy percent were female with a median age of 59 years. In spite of many recruitment challenges and barriers, we successfully recruited a large cohort whose data should provide some answers as to why Blacks have poorer health outcomes than several other ethnic groups, and help explain existing health disparities.

Ethics and Privacy Implications of Using the Internet and Social Media to Recruit Participants for Health Research: A Privacy-by-Design Framework for Online Recruitment

PubMed Central

Cyr, Alaina B; Arbuckle, Luk; Ferris, Lorraine E

2017-01-01

Background The Internet and social media offer promising ways to improve the reach, efficiency, and effectiveness of recruitment efforts at a reasonable cost, but raise unique ethical dilemmas. We describe how we used social media to recruit cancer patients and family caregivers for a research study, the ethical issues we encountered, and the strategies we developed to address them. Objective Drawing on the principles of Privacy by Design (PbD), a globally recognized standard for privacy protection, we aimed to develop a PbD framework for online health research recruitment. Methods We proposed a focus group study on the dietary behaviors of cancer patients and their families, and the role of Web-based dietary self-management tools. Using an established blog on our hospital website, we proposed publishing a recruitment post and sharing the link on our Twitter and Facebook pages. The Research Ethics Board (REB) raised concern about the privacy risks associated with our recruitment strategy; by clicking on a recruitment post, an individual could inadvertently disclose personal health information to third-party companies engaged in tracking online behavior. The REB asked us to revise our social media recruitment strategy with the following questions in mind: (1) How will you inform users about the potential for privacy breaches and their implications? and (2) How will you protect users from privacy breaches or inadvertently sharing potentially identifying information about themselves? Results Ethical guidelines recommend a proportionate approach to ethics assessment, which advocates for risk mitigation strategies that are proportional to the magnitude and probability of risks. We revised our social media recruitment strategy to inform users about privacy risks and to protect their privacy, while at the same time meeting our recruitment objectives. We provide a critical reflection of the perceived privacy risks associated with our social media recruitment strategy and

Improving Navy Recruiting with the New Planned Resource Optimization Model With Experimental Design (PROM-WED)

DTIC Science & Technology

2017-03-01

RECRUITING WITH THE NEW PLANNED RESOURCE OPTIMIZATION MODEL WITH EXPERIMENTAL DESIGN (PROM-WED) by Allison R. Hogarth March 2017 Thesis...with the New Planned Resource Optimization Model With Experimental Design (PROM-WED) 5. FUNDING NUMBERS 6. AUTHOR(S) Allison R. Hogarth 7. PERFORMING...has historically used a non -linear optimization model, the Planned Resource Optimization (PRO) model, to help inform decisions on the allocation of

The National Children's Study: Recruitment Outcomes Using the Provider-Based Recruitment Approach.

PubMed

Hale, Daniel E; Wyatt, Sharon B; Buka, Stephen; Cherry, Debra; Cislo, Kendall K; Dudley, Donald J; McElfish, Pearl Anna; Norman, Gwendolyn S; Reynolds, Simone A; Siega-Riz, Anna Maria; Wadlinger, Sandra; Walker, Cheryl K; Robbins, James M

2016-06-01

In 2009, the National Children's Study (NCS) Vanguard Study tested the feasibility of household-based recruitment and participant enrollment using a birth-rate probability sample. In 2010, the NCS Program Office launched 3 additional recruitment approaches. We tested whether provider-based recruitment could improve recruitment outcomes compared with household-based recruitment. The NCS aimed to recruit 18- to 49-year-old women who were pregnant or at risk for becoming pregnant who lived in designated geographic segments within primary sampling units, generally counties. Using provider-based recruitment, 10 study centers engaged providers to enroll eligible participants at their practice. Recruitment models used different levels of provider engagement (full, intermediate, information-only). The percentage of eligible women per county ranged from 1.5% to 57.3%. Across the centers, 3371 potential participants were approached for screening, 3459 (92%) were screened and 1479 were eligible (43%). Of those 1181 (80.0%) gave consent and 1008 (94%) were retained until delivery. Recruited participants were generally representative of the county population. Provider-based recruitment was successful in recruiting NCS participants. Challenges included time-intensity of engaging the clinical practices, differential willingness of providers to participate, and necessary reliance on providers for participant identification. The vast majority of practices cooperated to some degree. Recruitment from obstetric practices is an effective means of obtaining a representative sample. Copyright © 2016 by the American Academy of Pediatrics.

33 CFR 279.9 - Objective rationale.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Section 279.9 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE RESOURCE USE: ESTABLISHMENT OF OBJECTIVES § 279.9 Objective rationale. (a) Statement of objectives... objective(s) and providing the rationale, impact, and basic management measures for their accomplishment...

33 CFR 279.9 - Objective rationale.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Section 279.9 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE RESOURCE USE: ESTABLISHMENT OF OBJECTIVES § 279.9 Objective rationale. (a) Statement of objectives... objective(s) and providing the rationale, impact, and basic management measures for their accomplishment...

33 CFR 279.9 - Objective rationale.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Section 279.9 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE RESOURCE USE: ESTABLISHMENT OF OBJECTIVES § 279.9 Objective rationale. (a) Statement of objectives... objective(s) and providing the rationale, impact, and basic management measures for their accomplishment...

33 CFR 279.9 - Objective rationale.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Section 279.9 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE RESOURCE USE: ESTABLISHMENT OF OBJECTIVES § 279.9 Objective rationale. (a) Statement of objectives... objective(s) and providing the rationale, impact, and basic management measures for their accomplishment...

33 CFR 279.9 - Objective rationale.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Section 279.9 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE RESOURCE USE: ESTABLISHMENT OF OBJECTIVES § 279.9 Objective rationale. (a) Statement of objectives... objective(s) and providing the rationale, impact, and basic management measures for their accomplishment...

Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods.

PubMed

Apers, Silke; Kovacs, Adrienne H; Luyckx, Koen; Alday, Luis; Berghammer, Malin; Budts, Werner; Callus, Edward; Caruana, Maryanne; Chidambarathanu, Shanthi; Cook, Stephen C; Dellborg, Mikael; Enomoto, Junko; Eriksen, Katrine; Fernandes, Susan M; Jackson, Jamie L; Johansson, Bengt; Khairy, Paul; Kutty, Shelby; Menahem, Samuel; Rempel, Gwen; Sluman, Maayke A; Soufi, Alexandra; Thomet, Corina; Veldtman, Gruschen; Wang, Jou-Kou; White, Kamila; Moons, Philip

2015-01-20

Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research methods. The APPROACH-IS consortium (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study) was created for this purpose and investigates PROs in adults with CHD worldwide. This paper outlines the project rationale, design, and methods. APPROACH-IS is a cross-sectional study. The goal is to recruit 3500-4000 adults with CHD from 15 countries in five major regions of the world (Asia, Australia, Europe, North and South America). Self-report questionnaires are administered to capture information on PRO domains: (i) perceived health status (12-item Short-form Health Survey & EuroQOL-5D); (ii) psychological functioning (Hospital Anxiety and Depression Scale); (iii) health behaviors (Health-Behavior Scale-Congenital Heart Disease); and (iv) quality of life (Linear Analog Scale & Satisfaction With Life Scale). Additionally, potential explanatory variables are assessed: (i) socio-demographic variables; (ii) medical history (chart review); (iii) sense of coherence (Orientation to Life Questionnaire); and (iv) illness perceptions (Brief Illness Perception Questionnaire). Descriptive analyses and multilevel models will examine differences in PROs and investigate potential explanatory variables. APPROACH-IS represents a global effort to increase research understanding and capacity in the field of CHD, and will have major implications for patient care. Results will generate valuable information for developing interventions to optimize patients' health and well-being. ClinicalTrials.gov: NCT02150603. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Clinical Evaluation of Effects of Chronic Resveratrol Supplementation on Cerebrovascular Function, Cognition, Mood, Physical Function and General Well-Being in Postmenopausal Women-Rationale and Study Design.

PubMed

Evans, Hamish Michael; Howe, Peter Ranald Charles; Wong, Rachel Heloise Xiwen

2016-03-09

This methodological paper presents both a scientific rationale and a methodological approach for investigating the effects of resveratrol supplementation on mood and cognitive performance in postmenopausal women. Postmenopausal women have an increased risk of cognitive decline and dementia, which may be at least partly due to loss of beneficial effects of estrogen on the cerebrovasculature. We hypothesise that resveratrol, a phytoestrogen, may counteract this risk by enhancing cerebrovascular function and improving regional blood flow in response to cognitive demands. A clinical trial was designed to test this hypothesis. Healthy postmenopausal women were recruited to participate in a randomised, double-blind, placebo-controlled (parallel comparison) dietary intervention trial to evaluate the effects of resveratrol supplementation (75 mg twice daily) on cognition, cerebrovascular responsiveness to cognitive tasks and overall well-being. They performed the following tests at baseline and after 14 weeks of supplementation: Rey Auditory Verbal Learning Test, Cambridge Semantic Memory Battery, the Double Span and the Trail Making Task. Cerebrovascular function was assessed simultaneously by monitoring blood flow velocity in the middle cerebral arteries using transcranial Doppler ultrasound. This trial provides a model approach to demonstrate that, by optimising circulatory function in the brain, resveratrol and other vasoactive nutrients may enhance mood and cognition and ameliorate the risk of developing dementia in postmenopausal women and other at-risk populations.

The effect of army vest design on the occurrence of stress fractures and overuse injuries in female military recruits.

PubMed

Palmanovich, Ezequiel; Frankl, M; Nyska, M; Hetsroni, I; Constantini, N; Trejo, L; Bechar, R; Novak, G; Lankovsky, Z; Mann, G

2017-08-01

Stress fractures (SFs) occur when microdamage caused by repetitive mechanical load exceeds the biological load-bearing capacity of the bone. The study objective was to test whether a vest specifically designed and manufactured for female recruits, compared with the standard vest used on a regular basis by Border Police recruits, would reduce the incidence of SF in female Border Police recruits. Data based on reports of military personnel show that women are more likely to sustain SFs. A follow-up of 240 female Border Police infantry recruits, divided into two trial groups, was conducted from 2007 to 2009. Two different vests were evaluated-the standard special unit fighting vest, which was conventionally used by both men and women during basic training, and the new fighting vest, specially design for female body shape. No significant difference was noted in the number of SFs between the two groups which may be attributed to increased weight of the new vest. There was a lower incidence of long bone SFs which may have been due to the superior vest design. The female Border Police Infantry recruits expressed great satisfaction with the new vest. Increased effort should be invested to further reduce the weight of female combat gear, alongside efforts to improve fit and comfort. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study)

PubMed Central

2012-01-01

Background Randomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. Methods/Design Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs. We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. Discussion Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical

Ethics and Privacy Implications of Using the Internet and Social Media to Recruit Participants for Health Research: A Privacy-by-Design Framework for Online Recruitment.

PubMed

Bender, Jacqueline Lorene; Cyr, Alaina B; Arbuckle, Luk; Ferris, Lorraine E

2017-04-06

The Internet and social media offer promising ways to improve the reach, efficiency, and effectiveness of recruitment efforts at a reasonable cost, but raise unique ethical dilemmas. We describe how we used social media to recruit cancer patients and family caregivers for a research study, the ethical issues we encountered, and the strategies we developed to address them. Drawing on the principles of Privacy by Design (PbD), a globally recognized standard for privacy protection, we aimed to develop a PbD framework for online health research recruitment. We proposed a focus group study on the dietary behaviors of cancer patients and their families, and the role of Web-based dietary self-management tools. Using an established blog on our hospital website, we proposed publishing a recruitment post and sharing the link on our Twitter and Facebook pages. The Research Ethics Board (REB) raised concern about the privacy risks associated with our recruitment strategy; by clicking on a recruitment post, an individual could inadvertently disclose personal health information to third-party companies engaged in tracking online behavior. The REB asked us to revise our social media recruitment strategy with the following questions in mind: (1) How will you inform users about the potential for privacy breaches and their implications? and (2) How will you protect users from privacy breaches or inadvertently sharing potentially identifying information about themselves? Ethical guidelines recommend a proportionate approach to ethics assessment, which advocates for risk mitigation strategies that are proportional to the magnitude and probability of risks. We revised our social media recruitment strategy to inform users about privacy risks and to protect their privacy, while at the same time meeting our recruitment objectives. We provide a critical reflection of the perceived privacy risks associated with our social media recruitment strategy and the appropriateness of the risk

The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke.

PubMed

Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

2016-01-01

The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

The National Children’s Study: Recruitment Outcomes Using the Provider-Based Recruitment Approach

PubMed Central

Wyatt, Sharon B.; Buka, Stephen; Cherry, Debra; Cislo, Kendall K.; Dudley, Donald J.; McElfish, Pearl Anna; Norman, Gwendolyn S.; Reynolds, Simone A.; Siega-Riz, Anna Maria; Wadlinger, Sandra; Walker, Cheryl K.; Robbins, James M.

2016-01-01

OBJECTIVE: In 2009, the National Children’s Study (NCS) Vanguard Study tested the feasibility of household-based recruitment and participant enrollment using a birth-rate probability sample. In 2010, the NCS Program Office launched 3 additional recruitment approaches. We tested whether provider-based recruitment could improve recruitment outcomes compared with household-based recruitment. METHODS: The NCS aimed to recruit 18- to 49-year-old women who were pregnant or at risk for becoming pregnant who lived in designated geographic segments within primary sampling units, generally counties. Using provider-based recruitment, 10 study centers engaged providers to enroll eligible participants at their practice. Recruitment models used different levels of provider engagement (full, intermediate, information-only). RESULTS: The percentage of eligible women per county ranged from 1.5% to 57.3%. Across the centers, 3371 potential participants were approached for screening, 3459 (92%) were screened and 1479 were eligible (43%). Of those 1181 (80.0%) gave consent and 1008 (94%) were retained until delivery. Recruited participants were generally representative of the county population. CONCLUSIONS: Provider-based recruitment was successful in recruiting NCS participants. Challenges included time-intensity of engaging the clinical practices, differential willingness of providers to participate, and necessary reliance on providers for participant identification. The vast majority of practices cooperated to some degree. Recruitment from obstetric practices is an effective means of obtaining a representative sample. PMID:27251870

The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size®-based clinical trial: The "Health and Wellness in Obesity" study.

PubMed

Ulian, Mariana D; Gualano, Bruno; Benatti, Fabiana B; de Campos-Ferraz, Patricia Lopes; Coelho, Desire; Roble, Odilon J; Sabatini, Fernanda; Perez, Isabel; Aburad, Luiz; Pinto, Ana Jéssica; Vessoni, André; Victor, Jhessica Campos; Lima, Victoria Kupper; Unsain, Ramiro Fernandez; de Morais Sato, Priscila; Rogero, Marcelo Macedo; Toporcov, Tatiana Natasha; Scagliusi, Fernanda B

2017-12-01

This manuscript describes the design and rationale of a clinical trial that aims to investigate the multiple physiological, attitudinal, nutritional, and behavioral effects of a new interdisciplinary intervention based on the Health at Every Size® (HAES®) approach in obese women. This will be a prospective, 7-month, randomized (2:1), mixed-method clinical trial. Obese women will be recruited and randomly allocated into two groups. The intervention group (I-HAES®; proposed n = 40) will undertake a novel HAES®-based intervention. Participants will take part in an exercise program, nutrition counseling sessions, and philosophical workshops, all aligned with the principles of the HAES® approach. The control group (CTRL; proposed n = 20) will participate in a program using a traditional HAES®-based group format, characterized by bimonthly lectures about the same topics offered to the experimental group, encouraging the adoption of a healthy lifestyle. The following multiple quantitative outcomes will be assessed pre and post intervention: health-related quality of life, cardiovascular risk factors, anthropometric assessments, physical activity level, physical capacity and function, and psychological and behavioral assessments. Qualitative analysis will be used to evaluate the experiences of the participants throughout the intervention, as assessed by focus groups and semi-structured interviews. The interdisciplinary research team leading this study has varied and complementary expertise. The knowledge arising from this study will help to guide new interdisciplinary interventions with the potential to holistically improve the health of obese individuals. This trial is registered at Clinicaltrials.gov (NCT02102061).

Treatment rationale and design of the RAMNITA study: A phase II study of the efficacy of docetaxel + ramucirumab for non-small cell lung cancer with brain metastasis.

PubMed

Tanimura, Keiko; Uchino, Junji; Tamiya, Nobuyo; Kaneko, Yoshiko; Yamada, Tadaaki; Yoshimura, Kenichi; Takayama, Koichi

2018-06-01

We described the treatment rationale and procedure for a phase II study of docetaxel plus ramucirumab for non-small cell lung cancer (NSCLC) patients with brain metastasis (RAMNITA study: University Information Network Clinical Trials Registry identification no. [UMIN]: 000024551). Combination therapy of angiogenetic inhibitor with chemotherapy improved the outcome of patients with brain metastasis in previous reports; however, the efficacy of ramucirumab, a vascular endothelial growth factor receptor-2 monoclonal antibody, for brain metastasis has not been shown. This RAMNITA study is a prospective, multicenter, open-label, single-arm phase II study designed to evaluate efficacy and safety of docetaxel and ramucirumab for advanced NSCLC patients with brain metastasis. Eligible patients will receive docetaxel (60 mg/m) and ramucirumab (10 mg/kg) every 21 days until disease progression. The primary endpoint is progression-free survival (PFS), and secondary endpoints are overall survival, intracranial PFS, response rate, and safety. Sixty-five participants will be recruited from September 2017 to December 2019 and followed up for 1 year after final registration. The results from this study may suggest a treatment option for brain metastasis in NSCLC. The protocol was approved by the institutional review board of each study center. Written informed consent will be obtained from all patients before registration, in accordance with the Declaration of Helsinki.

Design and Rationale for a Parent-Led Intervention to Increase Fruit and Vegetable Intake in Young Childhood Cancer Survivors (Reboot): Protocol for a Pilot Study.

PubMed

Touyz, Lauren; Cohen, Jennifer; Wakefield, Claire; Grech, Allison; Garnett, Sarah; Gohil, Paayal; Cohn, Richard

2018-05-16

Poor dietary habits are common among childhood cancer survivors, despite increasing their risk of cardio metabolic complications after cancer treatment. Here, we describe the design and rationale for a pilot telephone-based, parent-led intervention aimed at increasing fruit and vegetable intake in young cancer survivors (Reboot). This pilot study aims to assess the feasibility and acceptability of delivering evidence-based telephone support to parents of childhood cancer survivors. A secondary aim includes assessing the effect of Reboot on improving childhood cancer survivors' dietary quality by increasing child fruit and vegetable intake and variety and its contribution to overall nutrient intake. We aim to recruit parents of 15 young cancer survivors aged 2 to 12 years who have completed cancer treatment less than five years ago. The intervention comprises of 4 weekly 45-minute telephone sessions led by a health professional and one booster session 6 weeks later. Sessions address the effects of cancer treatment on children's diets, recommended fruit and vegetable intake for children, and evidence-based strategies to promote the consumption of fruit and vegetables as well as to manage fussy eating. Reboot is based on an existing, evidence-based parent nutrition intervention and modified for childhood cancer survivors following extensive collaboration with experts in the field. Primary outcomes of feasibility and acceptability will be measured by the number of participants who complete all five sessions, average session length (minutes), length between sessions (days) and parent Likert ratings of the usefulness and impact of the intervention collected after the booster session. Of the 15 participants we aim to recruit, 3 have completed the intervention, 1 declined to participate, 11 are actively completing the intervention and 2 participants are providing written consent. The remaining 3 participants will be recruited via telephone follow-up calls. The intervention

Rationales for Challenged Books. [CD-ROM].

ERIC Educational Resources Information Center

National Council of Teachers of English, Urbana, IL.

This CD-ROM presents a collection of over 200 rationales for over 170 works (mainly novels but a few films) for use by teachers combating censorship. Some rationales on the disc are from published sources; others are student papers. Although the materials in the collection range from kindergarten through grade 12, the emphasis is on the middle…

Foraging recruitment by the Giant Tropical Ant Paraponera clavata (Hymenoptera, Formicidae)

USGS Publications Warehouse

Barrett, Bruce A.; Jorgenson, Clive D.; Looman, Sandra J.

1985-01-01

Increased foraging of an exceptionally abundant, but ephemeral, food source by ants can result from foraging excitement that does not include pheromone trails, tandem running, or from recruitment of other workers along pheromone trails (Carrol and Janzen, 1973). They also provided rationale for two types of short-lived pheromone trails resulting in mass or group recruitment. These both seem to fall into the Type II foraging strategy described by Oster and Wilson (1978). Neither of these discussions conveniently allow for pheromone recruitment by relatively small colonies of a primitive monomorphic species such as Paraponera clavata. Our observations suggest that recruitment to an abundant ephemeral food source does occur naturally and can be induced artificially in colonies of P. clavata.Paraponera clavata is considered primitive (Wilson, 1958), particularly in foraging habits (Young and Hermann, 1980; Young, 1977). Hermann (1973, 1975) reported the P. clavata, unlike more advanced species, forages independently; following shot periods of apparent group activity outside of the colony (Young and Hermann, 1980). It reportedly does not return to a food source when only part has been harvested. After returning to its colony with booty, a single worker resumes foraging independently, with no observable tendency to return to partially harvested booty or without recruiting additional workers to collect the remaining food (Hermann, 1973; Young and Hermann, 1980). Reports of independent foraging, lack of forager recruitment, and apparent lack of food source fidelity resulted in the assumption that P. clavata probably lacks an effective pheromone trail communication system (Young and Hermann, 1980).

Effects of Role and Assignment Rationale on Attitudes Formed During Peer Tutoring

PubMed Central

Bierman, Karen Linn; Furman, Wyndol

2012-01-01

This study examined the role of contextual factors, such as assignment rationale, on the attitudinal effects of peer tutoring. Fourth-grade children engaged in brief tutoring experiences as either a tutor or tutee. Subjects received four rationales for being selected as tutor or tutee: (a) a competence rationale, (b) a physical characteristic rationale, (c) a chance rationale, or (d) no rationale. As predicted, tutors had more positive attitudes than tutees when they had been given a competence or physical characteristic rationale but not when the tutors were provided a chance rationale or no rationale. Additionally, the tutors’ and tutees’ attitudes were enhanced when no rationale was provided. Results are discussed in terms of their implications for a role-theory analysis of tutoring and their implications for applied programs. PMID:23946549

Effects of Role and Assignment Rationale on Attitudes Formed During Peer Tutoring.

PubMed

Bierman, Karen Linn; Furman, Wyndol

1981-02-01

This study examined the role of contextual factors, such as assignment rationale, on the attitudinal effects of peer tutoring. Fourth-grade children engaged in brief tutoring experiences as either a tutor or tutee. Subjects received four rationales for being selected as tutor or tutee: (a) a competence rationale, (b) a physical characteristic rationale, (c) a chance rationale, or (d) no rationale. As predicted, tutors had more positive attitudes than tutees when they had been given a competence or physical characteristic rationale but not when the tutors were provided a chance rationale or no rationale. Additionally, the tutors' and tutees' attitudes were enhanced when no rationale was provided. Results are discussed in terms of their implications for a role-theory analysis of tutoring and their implications for applied programs.

Rationale, design and baseline characteristics of a randomized controlled trial of a web-based computer-tailored physical activity intervention for adults from Quebec City.

PubMed

Boudreau, François; Walthouwer, Michel Jean Louis; de Vries, Hein; Dagenais, Gilles R; Turbide, Ginette; Bourlaud, Anne-Sophie; Moreau, Michel; Côté, José; Poirier, Paul

2015-10-09

The relationship between physical activity and cardiovascular disease (CVD) protection is well documented. Numerous factors (e.g. patient motivation, lack of facilities, physician time constraints) can contribute to poor PA adherence. Web-based computer-tailored interventions offer an innovative way to provide tailored feedback and to empower adults to engage in regular moderate- to vigorous-intensity PA. To describe the rationale, design and content of a web-based computer-tailored PA intervention for Canadian adults enrolled in a randomized controlled trial (RCT). 244 men and women aged between 35 and 70 years, without CVD or physical disability, not participating in regular moderate- to vigorous-intensity PA, and familiar with and having access to a computer at home, were recruited from the Quebec City Prospective Urban and Rural Epidemiological (PURE) study centre. Participants were randomized into two study arms: 1) an experimental group receiving the intervention and 2) a waiting list control group. The fully automated web-based computer-tailored PA intervention consists of seven 10- to 15-min sessions over an 8-week period. The theoretical underpinning of the intervention is based on the I-Change Model. The aim of the intervention was to reach a total of 150 min per week of moderate- to vigorous-intensity aerobic PA. This study will provide useful information before engaging in a large RCT to assess the long-term participation and maintenance of PA, the potential impact of regular PA on CVD risk factors and the cost-effectiveness of a web-based computer-tailored intervention. ISRCTN36353353 registered on 24/07/2014.

Rationale and design of a large registry on renal denervation: the Global SYMPLICITY registry.

PubMed

Böhm, Michael; Mahfoud, Felix; Ukena, Christian; Bauer, Axel; Fleck, Eckart; Hoppe, Uta C; Kintscher, Ulrich; Narkiewicz, Krzysztof; Negoita, Manuela; Ruilope, Luis; Rump, L Christian; Schlaich, Markus; Schmieder, Roland; Sievert, Horst; Weil, Joachim; Williams, Bryan; Zeymer, Uwe; Mancia, Giuseppe

2013-08-22

Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure. The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities. The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.

Teaching Economics to Young Adolescents: A Research-Based Rationale.

ERIC Educational Resources Information Center

Davis, James E.

This booklet presents a research-based rationale for teaching economics at the middle/junior high school level in the United States. Chapter 1, "Introduction," describes the project in which the rationale was developed and outlines the remainder of the document. Chapter 2, "Elements of a Rationale for Middle School Economic Education," presents…

Rationale and Design of the Women and Inclusion in Academic Medicine Study.

PubMed

Hill, Emorcia V; Wake, Michael; Carapinha, René; Normand, Sharon-Lise; Wolf, Robert E; Norris, Keith; Reede, Joan Y

2016-04-21

Women of color (WOC) (African American, Hispanic, Native American/Alaskan Native, and Asian American) faculty remain disproportionately underrepresented among medical school faculty and especially at senior ranks compared with White female faculty. The barriers or facilitators to the career advancement of WOC are poorly understood. The Women and Inclusion in Academic Medicine (WIAM) study was developed to characterize individual, institutional and sociocultural factors that influence the entry, progression and persistence, and advancement of women faculty in academic medical careers with a focus on WOC. Using a purposive sample of 13 academic medical institutions, we collected qualitative interview data from 21 WOC junior faculty and quantitative data from 3,127 (38.9% of 8,053 eligible women) respondents via an online survey. To gather institutional data, we used an online survey and conducted 23 key administrative informant interviews from the 13 institutions. Grounded theory methodology will be used to analyze qualitative data. Multivariable analysis including hierarchical linear modeling will be used to investigate outcomes, such as the inclusiveness of organizational gender climate and women faculty's intent to stay. We describe the design, methods, rationale and limitations of one of the largest and most comprehensive studies of women faculty in academic medicine with a focus on WOC. This study will enhance our understanding of challenges that face women, and, especially WOC, faculty in academic medicine and will provide solutions at both the individual and institutional levels.

The credibility of exposure therapy: Does the theoretical rationale matter?

PubMed

Arch, Joanna J; Twohig, Michael P; Deacon, Brett J; Landy, Lauren N; Bluett, Ellen J

2015-09-01

Little is understood about how the public perceives exposure-based therapy (ET) for treating anxiety and trauma-related disorders or how ET rationales affect treatment credibility. Distinct approaches to framing ET are practiced, including those emphasized in traditional cognitive behavioral therapy, acceptance and commitment therapy, and the more recent inhibitory learning model. However, their relative effect on ET's credibility remains unknown. A final sample of 964 U.S. adults provided baseline views of ET. Participants rated ET treatment credibility following a simple ET definition (pre-rationale) and following randomization to rationale modules addressing ET goals, fear, and cognitive strategies from distinct theoretical perspectives (post-rationale). Baseline ET views, symptoms, and sociodemographic characteristics were examined as putative moderators and predictors. At baseline, the majority had never heard of ET. From pre- to post-rationale, ET treatment credibility significantly increased but the rationales' theoretical perspective had little impact. More negative baseline ET views, specific ethnic/racial minority group status, and lower education moderated or predicted greater increases in treatment credibility following the rationale. ET remains relatively unknown as a treatment for anxiety or trauma, supporting the need for direct-to-consumer marketing. Diverse theory-driven rationales similarly increased ET credibility, particularly among those less likely to use ET. Copyright © 2015 Elsevier Ltd. All rights reserved.

Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica

PubMed Central

Herrero, Rolando; Hildesheim, Allan; Rodríguez, Ana C; Wacholder, Sholom; Bratti, Concepción; Solomon, Diane; González, Paula; Porras, Carolina; Jiménez, Silvia; Guillen, Diego; Morales, Jorge; Alfaro, Mario; Cyr, Jean; Morrisey, Kerrygrace; Estrada, Yenory; Cortés, Bernal; Morera, Lidia Ana; Freer, Enrique; Schussler, John; Schiller, John; Lowy, Douglas; Schiffman, Mark

2008-01-01

We report the rationale, design, methods and details of participation of a community-based, double blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7,466 women (30% of those prescreened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and Gonorrhea testing. Eighty percent of the women received 3 doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self-collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant. PMID:18640170

Rationale, Design and Methods of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men in the Southeastern United States (The MARI Study)

PubMed Central

Hickson, DeMarc A.; Truong, Nhan L.; Smith-Bankhead, Neena; Sturdevant, Nikendrick; Duncan, Dustin T.; Schnorr, Jordan; Gipson, June A.; Mena, Leandro A.

2015-01-01

Background This paper describes the rationale, design, and methodology of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men (MSM) in the Southeastern United States (U.S.; known locally simply as the MARI Study). Methods Participants are African American MSM aged 18 years and older residing in the deep South. Results Between 2013 and 2015, 800 African American MSM recruited from two study sites (Jackson, MS and Atlanta, GA) will undergo a 1.5-hour examination to obtain anthropometric and blood pressure measures as well as to undergo testing for sexually transmitted infections (STI), including HIV. Intrapersonal, interpersonal, and environmental factors are assessed by audio computer-assisted self-interview survey. Primary outcomes include sexual risk behaviors (e.g., condomless anal sex) and prevalent STIs (HIV, syphilis, gonorrhea, and Chlamydia). Conclusion The MARI Study will typify the HIV environmental 'riskscape' and provide empirical evidence into novel ecological correlates of HIV risk among African American MSM in the deep South, a population most heavily impacted by HIV. The study's anticipated findings will be of interest to a broad audience and lead to more informed prevention efforts, including effective policies and interventions, that achieve the goals of the updated 2020 U.S. National HIV/AIDS Strategy. PMID:26700018

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.

Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices

PubMed Central

Frew, Paula M.; Saint-Victor, Diane S.; Isaacs, Margaret Brewinski; Kim, Sonnie; Swamy, Geeta K.; Sheffield, Jeanne S.; Edwards, Kathryn M.; Villafana, Tonya; Kamagate, Ouda; Ault, Kevin

2014-01-01

Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies. PMID:25425718

The Family Value of Information, Community Support, and Experience Study: Rationale, Design, and Methods of a "Family-Centered" Research Study.

PubMed

Reeves, Gloria M; Wehring, Heidi J; Connors, Kathleen M; Bussell, Kristin; Schiffman, Jason; Medoff, Deborah R; Tsuji, Thomas; Walker, Jane; Brown, Alicia; Strobeck, Danielle; Clough, Tammy; Rush, Caitlin B; Riddle, Mark A; Love, Raymond C; Zachik, Albert; Hoagwood, Kimberly; Olin, S Serene; Stephan, Sharon; Okuzawa, Nana; Edwards, Sarah; Baquet, Claudia; dosReis, Susan

2015-12-01

The Patient Protection and Affordable Care Act focuses on improving consumer engagement and patient-centered care. This article describes the design and rationale of a study targeting family engagement in pediatric mental health services. The study is a 90-day randomized trial of a telephone-delivered Family Navigator services versus usual care for parents of Medicaid-insured youth younger than 13 years with serious mental illness. Youth are identified through a pediatric antipsychotic medication preauthorization program. Family Navigators offer peer support to empower and engage parents in their child's recovery. Outcomes include parent report of empowerment, social support, satisfaction with child mental health services, and child functioning as well as claims-based measures of psychotherapy service utilization and antipsychotic medication dosage. The focus on "family-centered" care in this study is strongly supported by the active role of consumers in study design and implementation.

Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

PubMed

Sztam, Kevin A; Ndirangu, Murugi; Sheriff, Muhsin; Arpadi, Stephen M; Hawken, Mark; Rashid, Juma; Deckelbaum, Richard J; El Sadr, Wafaa M

2013-01-01

Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.

Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial.

PubMed

Napolitano, Melissa A; Whiteley, Jessica A; Mavredes, Meghan N; Faro, Jamie; DiPietro, Loretta; Hayman, Laura L; Neighbors, Charles J; Simmens, Samuel

2017-09-01

The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years. The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019. This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912. Copyright © 2017. Published by Elsevier Inc.

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

PubMed

Cho, Alex H; Killeya-Jones, Ley A; O'Daniel, Julianne M; Kawamoto, Kensaku; Gallagher, Patrick; Haga, Susanne; Lucas, Joseph E; Trujillo, Gloria M; Joy, Scott V; Ginsburg, Geoffrey S

2012-01-18

Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve

Rationales for the Lightning Launch Commit Criteria

NASA Technical Reports Server (NTRS)

Willett, John C. (Editor); Merceret, Francis J. (Editor); Krider, E. Philip; O'Brien, T. Paul; Dye, James E.; Walterscheid, Richard L.; Stolzenburg, Maribeth; Cummins, Kenneth; Christian, Hugh J.; Madura, John T.

2016-01-01

Since natural and triggered lightning are demonstrated hazards to launch vehicles, payloads, and spacecraft, NASA and the Department of Defense (DoD) follow the Lightning Launch Commit Criteria (LLCC) for launches from Federal Ranges. The LLCC were developed to prevent future instances of a rocket intercepting natural lightning or triggering a lightning flash during launch from a Federal Range. NASA and DoD utilize the Lightning Advisory Panel (LAP) to establish and develop robust rationale from which the criteria originate. The rationale document also contains appendices that provide additional scientific background, including detailed descriptions of the theory and observations behind the rationales. The LLCC in whole or part are used across the globe due to the rigor of the documented criteria and associated rationale. The Federal Aviation Administration (FAA) adopted the LLCC in 2006 for commercial space transportation and the criteria were codified in the FAA's Code of Federal Regulations (CFR) for Safety of an Expendable Launch Vehicle (Appendix G to 14 CFR Part 417, (G417)) and renamed Lightning Flight Commit Criteria in G417.

Conceptual and statistical issues in couples observational research: Rationale and methods for design decisions.

PubMed

Baucom, Brian R W; Leo, Karena; Adamo, Colin; Georgiou, Panayiotis; Baucom, Katherine J W

2017-12-01

Observational behavioral coding methods are widely used for the study of relational phenomena. There are numerous guidelines for the development and implementation of these methods that include principles for creating new and adapting existing coding systems as well as principles for creating coding teams. While these principles have been successfully implemented in research on relational phenomena, the ever expanding array of phenomena being investigated with observational methods calls for a similar expansion of these principles. Specifically, guidelines are needed for decisions that arise in current areas of emphasis in couple research including observational investigation of related outcomes (e.g., relationship distress and psychological symptoms), the study of change in behavior over time, and the study of group similarities and differences in the enactment and perception of behavior. This article describes conceptual and statistical considerations involved in these 3 areas of research and presents principle- and empirically based rationale for design decisions related to these issues. A unifying principle underlying these guidelines is the need for careful consideration of fit between theory, research questions, selection of coding systems, and creation of coding teams. Implications of (mis)fit for the advancement of theory are discussed. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Rationale, Timeline, Study Design, and Protocol Overview of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

PubMed Central

Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S.; Christensen, James R.; Dean, Michael

2014-01-01

Objective To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design Multicenter randomized controlled trials. Setting Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials. PMID:23842585

Guidelines for reporting embedded recruitment trials.

PubMed

Madurasinghe, Vichithranie W

2016-01-14

Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials. We followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines. We developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial. Implementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.

Alaska Special Education Recruitment and Retention Resource Manual.

ERIC Educational Resources Information Center

Schnorr, Janice M.; Brady, Nancy J.

This resource manual is designed to assist Alaska school districts in recruiting and retaining special education teachers. It offers 50 practical suggestions for developing an effective recruitment program, focusing on the processes of gathering information; developing recruiters, materials, and strategies; and screening and interviewing…

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

Today's Recruitment Trends.

ERIC Educational Resources Information Center

Sugarman, Joe

1996-01-01

Five trends in the creation of college student recruitment publications are identified: (1) using market research and marketing principles; (2) targeting specific groups; (3) honesty about campus personality and reputation; (4) cost-effectiveness; and (5) creativity in using effective copy and design. (MSE)

Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: Rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives

PubMed Central

Sparks, Jeffrey A.; Iversen, Maura D.; Kroouze, Rachel Miller; Mahmoud, Taysir G.; Triedman, Nellie A.; Kalia, Sarah S.; Atkinson, Michael L.; Lu, Bing; Deane, Kevin D.; Costenbader, Karen H.; Green, Robert C.; Karlson, Elizabeth W.

2014-01-01

We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. PMID:25151341

Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives.

PubMed

Sparks, Jeffrey A; Iversen, Maura D; Miller Kroouze, Rachel; Mahmoud, Taysir G; Triedman, Nellie A; Kalia, Sarah S; Atkinson, Michael L; Lu, Bing; Deane, Kevin D; Costenbader, Karen H; Green, Robert C; Karlson, Elizabeth W

2014-09-01

We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. Copyright © 2014 Elsevier Inc. All rights reserved.

Facilitating Development Research: Suggestions for Recruiting and Re-Recruiting Children and Families

PubMed Central

Hurwitz, Lisa B.; Schmitt, Kelly L.; Olsen, Megan K.

2017-01-01

Recruiting children and families for research studies can be challenging, and re-recruiting former participants for longitudinal research can be even more difficult, especially when a study was not prospectively designed to encompass continuous data collection. In this article, we explain how researchers can set up initial studies to potentially facilitate later waves of data collection; locate former study participants using newer, often digital, tools; schedule families using recruitment phone/email/mail scripts that highlight the many benefits to continued study participation; and confirm appointments with other digital tools. We draw from prior methodological and longitudinal pieces to provide suggestions to others wishing to re-recruit families for longitudinal studies. In addition, we draw upon our own experience conducting a non-prospective longitudinal study 6 years after an educational intervention, in which we successfully re-located 122 (90%) and interviewed 101 of 136 (83% of the located sample and 74% of the full original sample) parents and their early adolescent children. Although the majority of participants were recruited via original contact information (especially phone numbers), using a range of strategies to recruit (e.g., search engines focused on contact information, social media) and motivate participation (e.g., multifaceted phone/email/mail scheduling scripts, flexibility in location and means of participation) yielded a more desirable sample size at relatively low costs. PMID:28955265

Women in HIV cure research: multilevel interventions to improve sex equity in recruitment.

PubMed

Grewe, Mary E; Ma, Yuntong; Gilbertson, Adam; Rennie, Stuart; Tucker, Joseph D

Women are underrepresented in HIV cure research. In this paper we discuss the rationale for including women and propose multilevel strategies to improve sex equity in HIV cure research. The inadequate inclusion of women in HIV cure research is concerning for both scientific and ethical reasons. Biological responses to HIV and HIV treatment, as well as social contexts, differ between men and women, and this may affect the efficacy of curative interventions. Strategies for improving sex equity in HIV cure research include addressing eligibility criteria, adapting recruitment strategies, engaging community members early in the research process, and promoting funder policy changes. We conclude by describing the Gender, Race, and Clinical Experience (GRACE) study, which is one example of how women can be effectively recruited into HIV-related clinical trials. While HIV cure research is currently in the early stages, as it continues to develop it is important to mobilise for adequate inclusion of women.

Overcoming limitations in previous research on exercise as a smoking cessation treatment: rationale and design of the "Quit for Health" trial.

PubMed

Williams, David M; Ussher, Michael; Dunsiger, Shira; Miranda, Robert; Gwaltney, Chad J; Monti, Peter M; Emerson, Jessica

2014-01-01

Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)--an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants' natural environments. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

Recruiting Health Information Faculty: The Effects of Monetary Recruitment Incentives

ERIC Educational Resources Information Center

Winter, Paul A.; Logsdon, Marsha R.

2004-01-01

This paper addresses recruitment of Health Information faculty for community and technical colleges, an issue of crucial importance because many faculty hired during the enrollment boom of the 1960s are retiring. The design for this research was a factorial experiment, involving a two-way analysis of variance. The participants (N = 194) were…

Social network recruitment for Yo Puedo - an innovative sexual health intervention in an underserved urban neighborhood: sample and design implications

PubMed Central

Minnis, Alexandra M.; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Cheng, Helen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S.

2016-01-01

Most existing evidence-based sexual health interventions focus on individual-level behavior, even though there is substantial evidence that highlights the influential role of social environments in shaping adolescents’ behaviors and reproductive health outcomes. We developed Yo Puedo, a combined conditional cash transfer (CCT) and life skills intervention for youth to promote educational attainment, job training, and reproductive health wellness that we then evaluated for feasibility among 162 youth aged 16–21 years in a predominantly Latino community in San Francisco, CA. The intervention targeted youth’s social networks and involved recruitment and randomization of small social network clusters. In this paper we describe the design of the feasibility study and report participants’ baseline characteristics. Furthermore, we examined the sample and design implications of recruiting social network clusters as the unit of randomization. Baseline data provide evidence that we successfully enrolled high risk youth using a social network recruitment approach in community and school-based settings. Nearly all participants (95%) were high risk for adverse educational and reproductive health outcomes based on multiple measures of low socioeconomic status (81%) and/or reported high risk behaviors (e.g., gang affiliation, past pregnancy, recent unprotected sex, frequent substance use) (62%). We achieved variability in the study sample through heterogeneity in recruitment of the index participants, whereas the individuals within the small social networks of close friends demonstrated substantial homogeneity across sociodemographic and risk profile characteristics. Social networks recruitment was feasible and yielded a sample of high risk youth willing to enroll in a randomized study to evaluate a novel sexual health intervention. PMID:25358834

Social network recruitment for Yo Puedo: an innovative sexual health intervention in an underserved urban neighborhood—sample and design implications.

PubMed

Minnis, Alexandra M; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Cheng, Helen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S

2015-02-01

Most existing evidence-based sexual health interventions focus on individual-level behavior, even though there is substantial evidence that highlights the influential role of social environments in shaping adolescents' behaviors and reproductive health outcomes. We developed Yo Puedo, a combined conditional cash transfer and life skills intervention for youth to promote educational attainment, job training, and reproductive health wellness that we then evaluated for feasibility among 162 youth aged 16-21 years in a predominantly Latino community in San Francisco, CA. The intervention targeted youth's social networks and involved recruitment and randomization of small social network clusters. In this paper we describe the design of the feasibility study and report participants' baseline characteristics. Furthermore, we examined the sample and design implications of recruiting social network clusters as the unit of randomization. Baseline data provide evidence that we successfully enrolled high risk youth using a social network recruitment approach in community and school-based settings. Nearly all participants (95%) were high risk for adverse educational and reproductive health outcomes based on multiple measures of low socioeconomic status (81%) and/or reported high risk behaviors (e.g., gang affiliation, past pregnancy, recent unprotected sex, frequent substance use; 62%). We achieved variability in the study sample through heterogeneity in recruitment of the index participants, whereas the individuals within the small social networks of close friends demonstrated substantial homogeneity across sociodemographic and risk profile characteristics. Social networks recruitment was feasible and yielded a sample of high risk youth willing to enroll in a randomized study to evaluate a novel sexual health intervention.

Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials.

PubMed

Moler, Frank W; Silverstein, Faye S; Meert, Kathleen L; Clark, Amy E; Holubkov, Richard; Browning, Brittan; Slomine, Beth S; Christensen, James R; Dean, J Michael

2013-09-01

To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Multicenter randomized controlled trials. Pediatric intensive care and cardiac ICUs in the United States and Canada. Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Therapeutic hypothermia or therapeutic normothermia. From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.

Rationale for windshield glass system specification requirements for shuttle orbiter

NASA Technical Reports Server (NTRS)

Hayashida, K.; King, G. L.; Tesinsiky, J.; Wittenburg, D. R.

1972-01-01

A preliminary procurement specification for the space shuttle orbiter windshield pane, and some of the design considerations and rationale leading to its development are presented. The windshield designer is given the necessary methods and procedures for assuring glass pane structural integrity by proof test. These methods and procedures are fully developed for annealed and thermally tempered aluminosilicate, borosilicate, and soda lime glass and for annealed fused silica. Application of the method to chemically tempered glass is considered. Other considerations are vision requirements, protection against bird impact, hail, frost, rain, and meteoroids. The functional requirements of the windshield system during landing, ferrying, boost, space flight, and entry are included.

A Comparison of Three Online Recruitment Strategies for Engaging Parents.

PubMed

Dworkin, Jodi; Hessel, Heather; Gliske, Kate; Rudi, Jessie H

2016-10-01

Family scientists can face the challenge of effectively and efficiently recruiting normative samples of parents and families. Utilizing the Internet to recruit parents is a strategic way to find participants where they already are, enabling researchers to overcome many of the barriers to in-person recruitment. The present study was designed to compare three online recruitment strategies for recruiting parents: e-mail Listservs, Facebook, and Amazon Mechanical Turk (MTurk). Analyses revealed differences in the effectiveness and efficiency of data collection. In particular, MTurk resulted in the most demographically diverse sample, in a short period of time, with little cost. Listservs reached a large number of participants and resulted in a comparatively homogeneous sample. Facebook was not successful in recruiting a general sample of parents. Findings provide information that can help family researchers and practitioners be intentional about recruitment strategies and study design.

A Systematic Review and Meta-Analysis of Practices Exposing Humans to Avian Influenza Viruses, Their Prevalence, and Rationale

PubMed Central

Fournié, Guillaume; Høg, Erling; Barnett, Tony; Pfeiffer, Dirk U.; Mangtani, Punam

2017-01-01

Abstract. Almost all human infections by avian influenza viruses (AIVs) are transmitted from poultry. A systematic review was conducted to identify practices associated with human infections, their prevalence, and rationale. Observational studies were identified through database searches. Meta-analysis produced combined odds ratio estimates. The prevalence of practices and rationales for their adoptions were reported. Of the 48,217 records initially identified, 65 articles were included. Direct and indirect exposures to poultry were associated with infection for all investigated viral subtypes and settings. For the most frequently reported practices, association with infection seemed stronger in markets than households, for sick and dead than healthy poultry, and for H7N9 than H5N1. Practices were often described in general terms and their frequency and intensity of contact were not provided. The prevalence of practices was highly variable across studies, and no studies comprehensively explored reasons behind the adoption of practices. Combining epidemiological and targeted anthropological studies would increase the spectrum and detail of practices that could be investigated and should aim to provide insights into the rationale(s) for their existence. A better understanding of these rationales may help to design more realistic and acceptable preventive public health measures and messages. PMID:28749769

Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design.

PubMed

Liu, Liping; Wang, Yilong; Meng, Xia; Li, Na; Tan, Ying; Nie, Ximing; Liu, Dacheng; Zhao, Xingquan

2017-04-01

Rationale Acute intracerebral hemorrhage inflicts a high-economic and -health burden. Computed tomography angiography spot sign is a predictor of hematoma expansion, is associated with poor clinical outcome and is an important stratifying variable for patients treated with haemostatic therapy. Aims We aim to compare the effect of treatment with tranexamic acid to placebo for the prevention of hemorrhage growth in patients with high-risk acute intracerebral hemorrhage with a positive spot sign. Design The tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign (TRAIGE) is a prospective, multicenter, placebo-controlled, double-blind, investigator-led, randomized clinical trial that will include an estimated 240 participants. Patients with intracerebral hemorrhage demonstrating symptom onset within 8 h and with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy, will be enrolled to receive either tranexamic acid or placebo. The primary outcome measure is the presence of hemorrhage growth defined as an increase in intracerebral hemorrhage volume >33% or >6 ml from baseline to 24 ± 2 h. The secondary outcomes include safety and clinical outcomes. Conclusion The TRAIGE trial evaluates the efficacy of haemostatic therapy with tranexamic acid in the prevention of hemorrhage growth among high-risk patients with acute intracerebral hemorrhage.

Clinical Validation Trial of a Diagnostic for Ebola Zaire Antigen Detection: Design Rationale and Challenges to Implementation

PubMed Central

Schieffelin, John; Moses, Lina M; Shaffer, Jeffrey; Goba, Augustine; Grant, Donald S

2015-01-01

The current Ebola outbreak in West Africa has affected more people than all previous outbreaks combined. The current diagnostic method of choice, quantitative polymerase chain reaction, requires specialized conditions as well as specially trained technicians. Insufficient testing capacity has extended the time from sample collection to results. These delays have led to further delays in the transfer and treatment to Ebola Treatment Units. A sensitive and specific point-of-care device that could be used reliably in low resource settings by healthcare workers with minimal training would increase the efficiency of triage and appropriate transfer of care. This article describes a study designed to validate the sensitivity and specificity of the ReEBOVTM RDT using venous whole blood and capillary blood obtained via fingerprick. We present the scientific and clinical rationale for the decisions made in the design of a diagnostic validation study to be conducted in an outbreak setting. The multi-site strategy greatly complicated implementation. In addition, a decrease in cases in one geographic area along with a concomitant increase in other areas made site selection challenging. Initiation of clinical trials during rapidly evolving outbreaks requires significant cooperation on a national level between research teams implementing studies and clinical care providers. Coordination and streamlining of approval process is essential if trials are to be implemented in a timely fashion. PMID:26768566

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

PubMed

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

2016-12-08

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

Rationale and cross-sectional study design of the Research on Obesity and type 2 Diabetes among African Migrants: the RODAM study

PubMed Central

Agyemang, Charles; Beune, Erik; Meeks, Karlijn; Owusu-Dabo, Ellis; Agyei-Baffour, Peter; Aikins, Ama de-Graft; Dodoo, Francis; Smeeth, Liam; Addo, Juliet; Mockenhaupt, Frank P; Amoah, Stephen K; Schulze, Matthias B; Danquah, Ina; Spranger, Joachim; Nicolaou, Mary; Klipstein-Grobusch, Kerstin; Burr, Tom; Henneman, Peter; Mannens, Marcel M; van Straalen, Jan P; Bahendeka, Silver; Zwinderman, A H; Kunst, Anton E; Stronks, Karien

2014-01-01

Introduction Obesity and type 2 diabetes (T2D) are highly prevalent among African migrants compared with European descent populations. The underlying reasons still remain a puzzle. Gene–environmental interaction is now seen as a potential plausible factor contributing to the high prevalence of obesity and T2D, but has not yet been investigated. The overall aim of the Research on Obesity and Diabetes among African Migrants (RODAM) project is to understand the reasons for the high prevalence of obesity and T2D among sub-Saharan Africans in diaspora by (1) studying the complex interplay between environment (eg, lifestyle), healthcare, biochemical and (epi)genetic factors, and their relative contributions to the high prevalence of obesity and T2D; (2) to identify specific risk factors within these broad categories to guide intervention programmes and (3) to provide a basic knowledge for improving diagnosis and treatment. Methods and analysis RODAM is a multicentre cross-sectional study among homogenous sub-Saharan African participants (ie, Ghanaians) aged >25 years living in rural and urban Ghana, the Netherlands, Germany and the UK (http://rod-am.eu/). Standardised data on the main outcomes, genetic and non-genetic factors are collected in all locations. The aim is to recruit 6250 individuals comprising five subgroups of 1250 individuals from each site. In Ghana, Kumasi and Obuasi (urban stratum) and villages in the Ashanti region (rural stratum) are served as recruitment sites. In Europe, Ghanaian migrants are selected through the municipality or Ghanaian organisations registers. Ethics and dissemination Ethical approval has been obtained in all sites. This paper gives an overview of the rationale, conceptual framework and methods of the study. The differences across locations will allow us to gain insight into genetic and non-genetic factors contributing to the occurrence of obesity and T2D and will inform targeted intervention and prevention programmes, and

Rationale and cross-sectional study design of the Research on Obesity and type 2 Diabetes among African Migrants: the RODAM study.

PubMed

Agyemang, Charles; Beune, Erik; Meeks, Karlijn; Owusu-Dabo, Ellis; Agyei-Baffour, Peter; Aikins, Ama de-Graft; Dodoo, Francis; Smeeth, Liam; Addo, Juliet; Mockenhaupt, Frank P; Amoah, Stephen K; Schulze, Matthias B; Danquah, Ina; Spranger, Joachim; Nicolaou, Mary; Klipstein-Grobusch, Kerstin; Burr, Tom; Henneman, Peter; Mannens, Marcel M; van Straalen, Jan P; Bahendeka, Silver; Zwinderman, A H; Kunst, Anton E; Stronks, Karien

2014-03-21

Obesity and type 2 diabetes (T2D) are highly prevalent among African migrants compared with European descent populations. The underlying reasons still remain a puzzle. Gene-environmental interaction is now seen as a potential plausible factor contributing to the high prevalence of obesity and T2D, but has not yet been investigated. The overall aim of the Research on Obesity and Diabetes among African Migrants (RODAM) project is to understand the reasons for the high prevalence of obesity and T2D among sub-Saharan Africans in diaspora by (1) studying the complex interplay between environment (eg, lifestyle), healthcare, biochemical and (epi)genetic factors, and their relative contributions to the high prevalence of obesity and T2D; (2) to identify specific risk factors within these broad categories to guide intervention programmes and (3) to provide a basic knowledge for improving diagnosis and treatment. RODAM is a multicentre cross-sectional study among homogenous sub-Saharan African participants (ie, Ghanaians) aged >25 years living in rural and urban Ghana, the Netherlands, Germany and the UK (http://rod-am.eu/). Standardised data on the main outcomes, genetic and non-genetic factors are collected in all locations. The aim is to recruit 6250 individuals comprising five subgroups of 1250 individuals from each site. In Ghana, Kumasi and Obuasi (urban stratum) and villages in the Ashanti region (rural stratum) are served as recruitment sites. In Europe, Ghanaian migrants are selected through the municipality or Ghanaian organisations registers. Ethical approval has been obtained in all sites. This paper gives an overview of the rationale, conceptual framework and methods of the study. The differences across locations will allow us to gain insight into genetic and non-genetic factors contributing to the occurrence of obesity and T2D and will inform targeted intervention and prevention programmes, and provide the basis for improving diagnosis and treatment in these

An anthology: Rationale for a US ballistic missile defense (1969 - 1984)

NASA Astrophysics Data System (ADS)

Tircuit, E. C.

1985-04-01

This anthology is a selection and short synopsis of representative articles on the rationale for a US ballistic missile defense (BMD). Unclassified articles and documents were reviewed and analyzed to identify and include nine representative articles in the anthology. The anthology reduces the search for quality material on the subject and documents the fundamental rationale for a BMD. The author concluded that the fundamental rationale for a US BMD is to deter nuclear war. In addition, specific rationale for a US BMD is provided in the anthology. Finally, an extensive bibliography is included in the anthology to enhance further research on the subject.

A Comparison of Three Online Recruitment Strategies for Engaging Parents

PubMed Central

Dworkin, Jodi; Hessel, Heather; Gliske, Kate; Rudi, Jessie H.

2017-01-01

Family scientists can face the challenge of effectively and efficiently recruiting normative samples of parents and families. Utilizing the Internet to recruit parents is a strategic way to find participants where they already are, enabling researchers to overcome many of the barriers to in-person recruitment. The present study was designed to compare three online recruitment strategies for recruiting parents: e-mail Listservs, Facebook, and Amazon Mechanical Turk (MTurk). Analyses revealed differences in the effectiveness and efficiency of data collection. In particular, MTurk resulted in the most demographically diverse sample, in a short period of time, with little cost. Listservs reached a large number of participants and resulted in a comparatively homogeneous sample. Facebook was not successful in recruiting a general sample of parents. Findings provide information that can help family researchers and practitioners be intentional about recruitment strategies and study design. PMID:28804184

Longitudinal Andhra Pradesh Eye Disease Study: rationale, study design and research methodology.

PubMed

Khanna, Rohit C; Murthy, Gudlavalleti Vs; Marmamula, Srinivas; Mettla, Asha Latha; Giridhar, Pyda; Banerjee, Seema; Shekhar, Konegari; Chakrabarti, Subhabrata; Gilbert, Clare; Rao, Gullapalli N

2016-03-01

The rationale, objectives, study design and procedures for the longitudinal Andhra Pradesh Eye Disease Study are described. A longitudinal cohort study was carried out. Participants include surviving cohort from the rural component of Andhra Pradesh Eye Disease Study. During 1996-2000, Andhra Pradesh Eye Disease Survey was conducted in three rural (n = 7771) and one urban (n = 2522) areas (now called Andhra Pradesh Eye Disease Study 1). In 2009-2010, a feasibility exercise (Andhra Pradesh Eye Disease Study 2) for a longitudinal study (Andhra Pradesh Eye Disease Study 3) was undertaken in the rural clusters only, as urban clusters no longer existed. In Andhra Pradesh Eye Disease Study 3, a detailed interview will be carried out to collect data on sociodemographic factors, ocular and systemic history, risk factors, visual function, knowledge of eye diseases and barriers to accessing services. All participants will also undergo a comprehensive eye examination including photography of lens, optic disc and retina, Optic Coherence Tomography of the posterior segment, anthropometry, blood pressure and frailty measures. Measures include estimates of the incidence of visual impairment and age-related eye disease (lens opacities, glaucoma and age-related macular degeneration) and the progression of eye disease (lens opacities and myopia) and associated risk factors. Of the 7771 respondents examined in rural areas in Andhra Pradesh Eye Disease Study 1, 5447 (70.1%) participants were traced in Andhra Pradesh Eye Disease Study 2. These participants will be re-examined. Andhra Pradesh Eye Disease Study 3 will provide data on the incidence and progression of visual impairment and major eye diseases and their associated risk factors in India. The study will provide further evidence to aid planning eye care services. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

A Multi-site, Two-Phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, Design, and Methodology

PubMed Central

Weiss, Roger D.; Potter, Jennifer Sharpe; Provost, Scott E.; Huang, Zhen; Jacobs, Petra; Hasson, Albert; Lindblad, Robert; Connery, Hilary Smith; Prather, Kristi; Ling, Walter

2010-01-01

The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age ≥18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. PMID:20116457

A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): rationale, design, and methodology.

PubMed

Weiss, Roger D; Potter, Jennifer Sharpe; Provost, Scott E; Huang, Zhen; Jacobs, Petra; Hasson, Albert; Lindblad, Robert; Connery, Hilary Smith; Prather, Kristi; Ling, Walter

2010-03-01

The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age > or =18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. Copyright 2010 Elsevier Inc. All rights reserved.

A seamless phase IIB/III adaptive outcome trial: design rationale and implementation challenges.

PubMed

Chen, Y H Joshua; Gesser, Richard; Luxembourg, Alain

2015-02-01

The licensed four-valent prophylactic human papillomavirus vaccine is highly efficacious in preventing cervical, vulvar, vaginal, and anal cancers and related precancers caused by human papillomavirus types 6, 11, 16, and 18. These four types account for approximately 70% of cervical cancers. A nine-valent human papillomavirus vaccine, including the four original types (6, 11, 16, and 18) plus the next five most prevalent types in cervical cancer (31, 33, 45, 52, and 58) could provide approximately 90% overall cervical cancer coverage. To expedite the nine-valent human papillomavirus vaccine clinical development, an adaptive, seamless Phase IIB/III outcome trial with ∼ 15,000 subjects was conducted to facilitate dose formulation selection and provide pivotal evidence of safety and efficacy for regulatory registrations. We discuss the design rationale and implementation challenges of the outcome trial, focusing on the adaptive feature of the seamless Phase IIB/III design. Subjects were enrolled in two parts (Part A and Part B). Approximately 1240 women, 16-26 years of age, were enrolled in Part A for Phase IIB evaluation and equally randomized to one of three dose formulations of the nine-valent human papillomavirus vaccine or the four-valent human papillomavirus vaccine (active control). Based on an interim analysis of immunogenicity and safety, one dose formulation of the nine-valent human papillomavirus vaccine was selected for evaluation in the Phase III part of the study. Subjects enrolled in Part A who received the selected dose formulation of the nine-valent human papillomavirus vaccine or four-valent human papillomavirus vaccine continued to be followed up and contributed to the final efficacy and safety analyses. In addition, ∼ 13,400 women 16-26 years of age were enrolled in Part B, randomized to nine-valent human papillomavirus vaccine at the selected dose formulation or four-valent human papillomavirus vaccine, and followed for immunogenicity

Designing medical internships to improve recruitment and retention of doctors in rural areas

PubMed Central

Gaski, Margrete; Abelsen, Birgit

2017-01-01

ABSTRACT Background: The medical internship as a way of exposing young doctors to training in a rural context is regarded as a useful tool to recruit and retain doctors in rural areas. Norwegian health authorities tested an arrangement of early sign-up for medical internships in the Finnmark County in Norway. Objective: To report on the effects of the early sign-up for medical internship. Design: This study compares the choice of workplace after internship among physicians who signed up early with those candidates assigned to the raffle model of internship in the study area, and in a comparison area experiencing similar recruitment and retention problems. Results: The proportion of interns who signed up early that still worked as physicians in the study area by April 2014 (29%) was twice as high as among the regular interns (15%) and interns in the comparison area (14%). Among the 59 interns who signed up early still working in the study area in April 2014, 33% had grown up in this area. However, the greatest benefits were for the most densely populated municipalities in the study area. Conclusions: The early sign-up model had a net contribution of proving additional physicians in the study area. PMID:28417680

Using a Non-Equivalent Groups Quasi Experimental Design to Reduce Internal Validity Threats to Claims Made by Math and Science K-12 Teacher Recruitment Programs

NASA Astrophysics Data System (ADS)

Moin, Laura

2009-10-01

The American Recovery and Reinvestment Act national policy established in 2009 calls for ``meaningful data'' that demonstrate educational improvements, including the recruitment of high-quality teachers. The scant data available and the low credibility of many K-12 math/science teacher recruitment program evaluations remain the major barriers for the identification of effective recruitment strategies. Our study presents a methodology to better evaluate the impact of recruitment programs on increasing participants' interest in teaching careers. The research capitalizes on the use of several control groups and presents a non-equivalent groups quasi-experimental evaluation design that produces program effect claims with higher internal validity than claims generated by current program evaluations. With this method that compares responses to a teaching career interest question from undergraduates all along a continuum from just attending an information session to participating (or not) in the recruitment program, we were able to compare the effect of the program in increasing participants' interest in teaching careers versus the evolution of the same interest but in the absence of the program. We were also able to make suggestions for program improvement and further research. While our findings may not apply to other K-12 math/science teacher recruitment programs, we believe that our evaluation methodology does and will contribute to conduct stronger program evaluations. In so doing, our evaluation procedure may inform recruitment program designers and policy makers.

The Volunteer Recruitment (and Membership Development) Book. Second Edition.

ERIC Educational Resources Information Center

Ellis, Susan J.

This book is designed to help nonprofit organizations recruit and retain volunteers. Following an introductory section covering the recruitment and use of volunteers, it contains 14 chapters organized in 3 sections. The chapters in the first section discuss what volunteer recruiters need to do before actually asking anyone to volunteer. They…

Overcoming Limitations in Previous Research on Exercise as a Smoking Cessation Treatment: Rationale and Design of the “Quit for Health” Trial

PubMed Central

Williams, David M.; Ussher, Michael; Dunsiger, Shira; Miranda, Robert; Gwaltney, Chad J.; Monti, Peter M.; Emerson, Jessica

2013-01-01

Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)—an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants’ natural environments. PMID:24246818

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

PubMed

Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

2017-11-01

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

The steps to health employee weight management randomized control trial: rationale, design and baseline characteristics.

PubMed

Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

2013-07-01

The workplace can be an important setting for addressing obesity. An increasing number of employers offer weight management programs. Present the design, rationale and baseline characteristics of the Steps to Health study (STH), a randomized trial to evaluate the effectiveness of two preexisting employee weight management programs offered at Duke University and Medical Center. 550 obese (BMI ≥30) employee volunteers were randomized 1:1 to two programs. Baseline data, collected between January 2011 and July 2012, included height/weight, accelerometry, workplace injuries, health care utilization, and questionnaires querying socio-cognitive factors, perceptions of health climate, physical activity, and dietary intake. In secondary analyses participants in the two programs will also be compared to a non-randomized observational control group of obese employees. At baseline, the mean age was 45 years, 83% were female, 41% white, and 53% black. Mean BMI was 37.2. Participants consumed a mean of 2.37 servings of fruits and vegetables per day (in the past week), participated in 11.5 min of moderate-to-vigorous physical activity, and spent 620 min being sedentary. STH addresses the need for evaluation of worksite interventions to promote healthy weight. In addition to having direct positive effects on workers' health, worksite programs have the potential to increase productivity and reduce health care costs. Copyright © 2013 Elsevier Inc. All rights reserved.

Rationale and Design of the Lung Cancer Screening Implementation. Evaluation of Patient-Centered Care Study.

PubMed

Miranda, Leah S; Datta, Santanu; Melzer, Anne C; Wiener, Renda Soylemez; Davis, James M; Tong, Betty C; Golden, Sara E; Slatore, Christopher G

2017-10-01

Screening for lung cancer using low-dose computed tomography has been demonstrated to reduce lung cancer-related mortality and is being widely implemented. Further research in this area is needed to assess the impact of screening on patient-centered outcomes. Here, we describe the design and rationale for a new study entitled Lung Cancer Screening Implementation: Evaluation of Patient-Centered Care. The protocol is composed of an interconnected series of studies evaluating patients and clinicians who are engaged in lung cancer screening in real-world settings. The primary goal of this study is to evaluate communication processes that are being used in routine care and to identify best practices that can be readily scaled up for implementation in multiple settings. We hypothesize that higher overall quality of patient-clinician communication processes will be associated with lower levels of distress and decisional conflict as patients decide whether or not to participate in lung cancer screening. This work is a critical step toward identifying modifiable mechanisms that are associated with high quality of care for the millions of patients who will consider lung cancer screening. Given the enormous potential benefits and burdens of lung cancer screening on patients, clinicians, and the healthcare system, it is important to identify and then scale up quality communication practices that positively influence patient-centered care.

Interim Methadone and Patient Navigation in Jail: Rationale and Design of a Randomized Clinical Trial

PubMed Central

Schwartz, Robert P.; Kelly, Sharon M.; Mitchell, Shannon G.; Dunlap, Laura; Zarkin, Gary A.; Sharma, Anjalee; O’Grady, Kevin E.; Jaffe, Jerome H.

2016-01-01

Background Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. Methods This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30 days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. Results We describe the background and rationale for the study, its aims, hypotheses, and study design. Conclusions Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. PMID:27282117

Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial.

PubMed

Schwartz, Robert P; Kelly, Sharon M; Mitchell, Shannon G; Dunlap, Laura; Zarkin, Gary A; Sharma, Anjalee; O'Grady, Kevin E; Jaffe, Jerome H

2016-07-01

Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. We describe the background and rationale for the study, its aims, hypotheses, and study design. Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. ClinicalTrials.gov: NCT02334215. Copyright © 2016 Elsevier Inc. All rights reserved.

Kids and adults now! Defeat Obesity (KAN-DO): rationale, design and baseline characteristics.

PubMed

Ostbye, Truls; Zucker, Nancy L; Krause, Katrina M; Lovelady, Cheryl A; Evenson, Kelly R; Peterson, Bercedis L; Bastian, Lori A; Swamy, Geeta K; West, Deborah G; Brouwer, Rebecca J N

2011-05-01

Prevention of childhood obesity is a public health priority. Parents influence a child's weight by modeling healthy behaviors, controlling food availability and activity opportunities, and appropriate feeding practices. Thus interventions should target education and behavioral change in the parent, and positive, mutually reinforcing behaviors within the family. This paper presents the design, rationale and baseline characteristics of Kids and Adults Now! - Defeat Obesity (KAN-DO), a randomized controlled behavioral intervention trial targeting weight maintenance in children of healthy weight, and weight reduction in overweight children. 400 children aged 2-5 and their overweight or obese mothers in the Triangle and Triad regions of North Carolina are randomized equally to control or the KAN-DO intervention, consisting of mailed family kits encouraging healthy lifestyle change. Eight (monthly) kits are supported by motivational counseling calls and a single group session. Mothers are targeted during a hypothesized "teachable moment" for health behavior change (the birth of a new baby), and intervention content addresses: parenting skills ((e.g., emotional regulation, authoritative parenting), healthy eating, and physical activity. The 400 mother-child dyads randomized to trial are 75% white and 22% black; 19% have a household income of $30,000 or below. At baseline, 15% of children are overweight (85th-95th percentile for body mass index) and 9% are obese (≥ 95th percentile). This intervention addresses childhood obesity prevention by using a family-based, synergistic approach, targeting at-risk children and their mothers during key transitional periods, and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change. Copyright © 2011 Elsevier Inc. All rights reserved.

Kids and Adults Now! Defeat Obesity (KAN-DO): Rationale, Design and Baseline Characteristics

PubMed Central

Østbye, Truls; Zucker, Nancy; Krause, Katrina M.; Lovelady, Cheryl A.; Evenson, Kelly; Peterson, Bercedis L.; Bastian, Lori A.; Swamy, Geeta K.; West, Deborah J; Brouwer, Rebecca JN

2011-01-01

Background Prevention of childhood obesity is a public health priority. Parents influence a child’s weight by modeling healthy behaviors, controlling food availability and activity opportunities, and appropriate feeding practices. Thus interventions should target education and behavioral change in the parent, and positive, mutually reinforcing behaviors within the family. Methods This paper presents the design, rationale and baseline characteristics of Kids and Adults Now! – Defeat Obesity (KAN-DO), a randomized controlled behavioral intervention trial targeting weight maintenance in children of healthy weight, and weight reduction in overweight children. 400 children aged 2–5 and their overweight or obese mothers in the Triangle and Triad regions of North Carolina are randomized equally to control or the KAN-DO intervention, consisting of mailed family kits encouraging healthy lifestyle change. Eight (monthly) kits are supported by motivational counseling calls and a single group session. Mothers are targeted during a hypothesized “teachable moment” for health behavior change (the birth of a new baby), and intervention content addresses: parenting skills (emotional regulation, authoritative parenting), healthy eating, and physical activity. Results The 400 mother-child dyads randomized to trial are 75% white and 22% black; 19% have a household income of $30,000 or below. At baseline, 15% of children are overweight (85th–95th percentile for body mass index) and 9% are obese (≥95th percentile). Conclusion This intervention addresses childhood obesity prevention by using a family-based, synergistic approach, targeting at-risk children and their mothers during key transitional periods, and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change. PMID:21300177

Education about Aging: A Rationale.

ERIC Educational Resources Information Center

Wass, Hannelore; And Others

1981-01-01

Reviews studies on children's and adolescents' attitudes about aging. Analyzes media content such as children's literature, textbooks, and public television programs to determine how older persons are portrayed. Provides a rationale for systematic education about aging in the public schools. (Author)

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

PubMed

Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H

2016-03-01

A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. Copyright © 2016 Elsevier Inc. All rights reserved.

West End Walkers 65+: a randomised controlled trial of a primary care-based walking intervention for older adults: study rationale and design.

PubMed

Macmillan, Freya; Fitzsimons, Claire; Black, Karen; Granat, Malcolm H; Grant, Margaret P; Grealy, Madeleine; Macdonald, Hazel; McConnachie, Alex; Rowe, David A; Shaw, Rebecca; Skelton, Dawn A; Mutrie, Nanette

2011-02-19

In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged 65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group) or a 12-week waiting list control group (delayed group) who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor), mood (Positive and Negative Affect Schedule), functional ability (Perceived Motor-Efficacy Scale for Older Adults), quality of life (Short-Form (36) Health Survey version 2) and loneliness (UCLA Loneliness Scale) were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged 65 years. The study will also examine the effect of the intervention on the well-being of

Zambian Peer Educators for HIV Self-Testing (ZEST) study: rationale and design of a cluster randomised trial of HIV self-testing among female sex workers in Zambia.

PubMed

Oldenburg, Catherine E; Ortblad, Katrina F; Chanda, Michael M; Mwanda, Kalasa; Nicodemus, Wendy; Sikaundi, Rebecca; Fullem, Andrew; Barresi, Leah G; Harling, Guy; Bärnighausen, Till

2017-04-20

HIV testing and knowledge of status are starting points for HIV treatment and prevention interventions. Among female sex workers (FSWs), HIV testing and status knowledge remain far from universal. HIV self-testing (HIVST) is an alternative to existing testing services for FSWs, but little evidence exists how it can be effectively and safely implemented. Here, we describe the rationale and design of a cluster randomised trial designed to inform implementation and scale-up of HIVST programmes for FSWs in Zambia. The Zambian Peer Educators for HIV Self-Testing (ZEST) study is a 3-arm cluster randomised trial taking place in 3 towns in Zambia. Participants (N=900) are eligible if they are women who have exchanged sex for money or goods in the previous 1 month, are HIV negative or status unknown, have not tested for HIV in the previous 3 months, and are at least 18 years old. Participants are recruited by peer educators working in their communities. Participants are randomised to 1 of 3 arms: (1) direct distribution (in which they receive an HIVST from the peer educator directly); (2) fixed distribution (in which they receive a coupon with which to collect the HIVST from a drug store or health post) or (3) standard of care (referral to existing HIV testing services only, without any offer of HIVST). Participants are followed at 1 and 4 months following distribution of the first HIVST. The primary end point is HIV testing in the past month measured at the 1-month and 4-month visits. This study was approved by the Institutional Review Boards at the Harvard T.H. Chan School of Public Health in Boston, USA and ERES Converge in Lusaka, Zambia. The findings of this trial will be presented at local, regional and international meetings and submitted to peer-reviewed journals for publication. Pre-results; NCT02827240. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods.

PubMed

Swift, Damon L; Dover, Sara E; Nevels, Tyara R; Solar, Chelsey A; Brophy, Patricia M; Hall, Tyler R; Houmard, Joseph A; Lutes, Lesley D

2015-11-01

Recent data has suggested that prolonged sedentary behavior is independent risk factor for cardiovascular and all-cause mortality independent of adequate amounts of moderate to vigorous physical activity. However, few studies have prospectively evaluated if exercise training and increasing non-exercise physical activity leads to greater reduction in cardiometabolic risk compared to aerobic training alone. The purpose of the Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study is to determine whether a physical activity program composed of both aerobic training (consistent with public health recommendations) and increasing non-exercise physical activity (3000 steps above baseline levels) leads to enhanced improvements in waist circumference, oral glucose tolerance, systemic inflammation, body composition, and fitness compared to aerobic training alone in obese adults (N=45). Commercially available accelerometers (Fitbits) will be used to monitor physical activity levels and behavioral coaching will be used to develop strategies of how to increase non-exercise physical activity levels. In this manuscript, we describe the design, rationale, and methodology associated with the I-CAN study. Copyright © 2015 Elsevier Inc. All rights reserved.

Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods

PubMed Central

2013-01-01

Background Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) study, a federally funded, randomized trial comparing two pharmacologic strategies against a control condition to manage SGA-related weight gain. Methods The design and methodology considerations of the IMPACT trial are described and embedded in a description of health risks associated with antipsychotic-related weight gain and the limitations of currently available research. Results The IMPACT study is a 4-site, six month, randomized, open-label, clinical trial of overweight/obese youth ages 8–19 years with pediatric schizophrenia-spectrum and bipolar-spectrum disorders, psychotic or non-psychotic major depressive disorder, or irritability associated with autistic disorder. Youth who have experienced clinically significant weight gain during antipsychotic treatment in the past 3 years are randomized to either (1) switch antipsychotic plus healthy lifestyle education (HLE); (2) add metformin plus HLE; or (3) HLE with no medication change. The primary aim is to compare weight change (body mass index z-scores) for each pharmacologic intervention with the control condition. Key secondary assessments include percentage body fat, insulin resistance, lipid profile, psychiatric symptom stability (monitored independently by the pharmacotherapist and a blinded evaluator), and all-cause and specific cause discontinuation. This study is ongoing, and the targeted sample size is 132 youth. Conclusion Antipsychotic-related weight gain is an important public health issue for youth requiring

The 1984 ARI Survey of Army Recruits: User’s Manual

DTIC Science & Technology

1986-05-01

KCEY WOROS (Caiu.a on toaa.. aide linaloiiaial ai .,, Ida &r bloog naea Army Recruiting, New Recruit Survey Enlistment Motivations . -’Recruit...designed in 1982 to answer questions concerning the demo- graphics and enlistment motivations of new Army recruits. In addition to the ability to track...SURVIY OF ARMY RECRUITS: USER’S MANUAL EXECUTIVE SUMMArY ~Reguirement: To obtain information on the characteristics, enlistment motivations , attitudes

Rationale for Student Dress Codes: A Review of School Handbooks

ERIC Educational Resources Information Center

Freeburg, Elizabeth W.; Workman, Jane E.; Lentz-Hees, Elizabeth S.

2004-01-01

Through dress codes, schools establish rules governing student appearance. This study examined stated rationales for dress and appearance codes in secondary school handbooks; 182 handbooks were received. Of 150 handbooks containing a rationale, 117 related dress and appearance regulations to students' right to a non-disruptive educational…

Bioethics: A Rationale and a Model

ERIC Educational Resources Information Center

Barman, Charles R.; Rusch, John J.

1978-01-01

Discusses the rationale for and development of an undergraduate bioethics course. Based on experiences with the course, general suggestions are offered to instructors planning to add bioethics to existing curricula. (MA)

Rationale for Students' Participation in University Governance and Organizational Effectiveness in Ekiti and Ondo States, Nigeria

ERIC Educational Resources Information Center

Akomolafe, C. O.; Ibijola, E. Y.

2012-01-01

The study investigated the rationale for students' participation in university governance and organizational effectiveness. A descriptive research of survey design was adopted. The population consisted of all staff and students of Ekiti State University, Ado Ekiti, Ekiti State and Adekunle Ajasin University, Akungba-Akoko, Ondo State. 700 subjects…

Conservation of design knowledge. [of large complex spaceborne systems

NASA Technical Reports Server (NTRS)

Sivard, Cecilia; Zweben, Monte; Cannon, David; Lakin, Fred; Leifer, Larry

1989-01-01

This paper presents an approach for acquiring knowledge about a design during the design process. The objective is to increase the efficiency of the lifecycle management of a space-borne system by providing operational models of the system's structure and behavior, as well as the design rationale, to human and automated operators. A design knowledge acquisition system is under development that compares how two alternative design versions meet the system requirements as a means for automatically capturing rationale for design changes.

"Socialized Music": Historical Formations of Community Music through Social Rationales

ERIC Educational Resources Information Center

Yerichuk, Deanna

2014-01-01

This article traces the formation of community music through professional and scholarly articles over the last century in North America, and argues that community music has been discursively formed through social rationales, although the specific rationales have shifted. The author employs an archaeological framework inspired by Michel Foucault to…

Employee recruitment.

PubMed

Breaugh, James A

2013-01-01

The way an organization recruits can influence the type of employees it hires, how they perform, and their retention rate. This article provides a selective review of research that has addressed recruitment targeting, recruitment methods, the recruitment message, recruiters, the organizational site visit, the job offer, and the timing of recruitment actions. These and other topics (e.g., the job applicant's perspective) are discussed in terms of their potential influence on prehire (e.g., the quality of job applicants) and posthire (e.g., new employee retention) recruitment outcomes. In reviewing research, attention is given to the current state of scientific knowledge, limitations of previous research, and important issues meriting future investigation.

Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness

PubMed Central

Howard, Louise; de Salis, Isabel; Tomlin, Zelda; Thornicroft, Graham; Donovan, Jenny

2009-01-01

Background Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. Aim To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness Methods Qualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques. Results Recruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism. Conclusion Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials. PMID:18718555

Utilization of Design Principles for Hybrid Learning Configurations by Interprofessional Design Teams

ERIC Educational Resources Information Center

Cremers, Petra H. M.; Wals, Arjen E. J.; Wesselink, Renate; Mulder, Martin

2017-01-01

Educational design research yields design knowledge, often in the form of design principles or guidelines that provide the rationale or "know-why" for the design of educational interventions. As such, design principles can be utilized by designers in contexts other than the research context in which they were generated. Although research…

The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods.

PubMed

Humphrey, Jean H; Jones, Andrew D; Manges, Amee; Mangwadu, Goldberg; Maluccio, John A; Mbuya, Mduduzi N N; Moulton, Lawrence H; Ntozini, Robert; Prendergast, Andrew J; Stoltzfus, Rebecca J; Tielsch, James M

2015-12-15

among a subgroup of infants enrolled in an EED substudy. This article describes the rationale, design, and methods underlying the SHINE trial. NCT01824940. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods.

PubMed

Williams, Allison N; Konopken, Yolanda P; Keller, Colleen S; Castro, Felipe Gonzalez; Arcoleo, Kimberly J; Barraza, Estela; Patrick, Donald L; Olson, Micah L; Shaibi, Gabriel Q

2017-03-01

Type 2 diabetes (T2D) disproportionately impacts Latino youth yet few diabetes prevention programs address this important source of health disparities. To address this knowledge gap, we describe the rationale, design, and methodology underpinning a culturally-grounded T2D prevention program for obese Latino youth. The study aims to: 1) to test the efficacy of the intervention for reducing T2D risk, 2) explore potential mediators and moderators of changes in health behaviors and health outcomes and, 3) examine the incremental cost-effectiveness for reducing T2D risk. Latino adolescents (N=160, age 14-16) will be randomized to either a 3-month intensive lifestyle intervention or a control condition. The intervention consists of weekly health education delivered by bilingual/bicultural promotores and 3 moderate-to-vigorous physical activity (PA) sessions/week. Control youth receive health information and results from their laboratory testing. Insulin sensitivity, glucose tolerance, and weight-specific quality of life are assessed at baseline, 3-months, 6-months, and 12-months. We will explore whether enhanced self-efficacy and/or social support mediate improvements in nutrition/PA behaviors and T2D outcomes. We will also explore whether effects are moderated by sex and/or acculturation. Cost-effectiveness from the health system perspective will be estimated by the incremental cost-effectiveness ratio using changes in insulin sensitivity at 12-months. The results of this study will provide much needed information on how T2D prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution oriented programs to prevent T2D in this and other high-risk populations. Copyright © 2017 Elsevier Inc. All rights reserved.

Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods

PubMed Central

Williams, AN; Konopken, YP; Keller, CS; Castro, FG; Arcoleo, K; Barraza, E; Patrick, DL; Olson, ML; Shaibi, GQ

2017-01-01

Background Type 2 diabetes (T2D) disproportionately impacts Latino youth yet few diabetes prevention programs address this important source of health disparities. Objectives To address this knowledge gap, we describe the rationale, design, and methodology underpinning a culturally-grounded T2D prevention program for obese Latino youth. The study aims to: 1) to test the efficacy of the intervention for reducing T2D risk, 2) explore potential mediators and moderators of changes in health behaviors and health outcomes and, 3) examine the incremental cost-effectiveness for reducing T2D risk. Latino adolescents (N=160, age 14–16) will be randomized to either a 3-month intensive lifestyle intervention or a control condition. The intervention consists of weekly health education delivered by bilingual/bicultural promotores and 3 moderate-to-vigorous physical activity (PA) sessions/week. Control youth receive health information and results from their laboratory testing. Insulin sensitivity, glucose tolerance, and weight-specific quality of life are assessed at baseline, 3-months, 6-months, and 12-months. We will explore whether enhanced self-efficacy and/or social support mediate improvements in nutrition/PA behaviors and T2D outcomes. We will also explore whether effects are moderated by sex and/or acculturation. Cost-effectiveness from the health system perspective will be estimated by the incremental cost-effectiveness ratio using changes in insulin sensitivity at 12-months. Conclusions The results of this study will provide much needed information on how T2D prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution oriented programs to prevent T2D in this and other high-risk populations. PMID:28104469

Insights into Cullin-RING E3 ubiquitin ligase recruitment: structure of the VHL-EloBC-Cul2 complex.

PubMed

Nguyen, Henry C; Yang, Haitao; Fribourgh, Jennifer L; Wolfe, Leslie S; Xiong, Yong

2015-03-03

The von Hippel-Lindau tumor suppressor protein (VHL) recruits a Cullin 2 (Cul2) E3 ubiquitin ligase to downregulate HIF-1α, an essential transcription factor for the hypoxia response. Mutations in VHL lead to VHL disease and renal cell carcinomas. Inhibition of this pathway to upregulate erythropoietin production is a promising new therapy to treat ischemia and chronic anemia. Here, we report the crystal structure of VHL bound to a Cul2 N-terminal domain, Elongin B, and Elongin C (EloC). Cul2 interacts with both the VHL BC box and cullin box and a novel EloC site. Comparison with other cullin E3 ligase structures shows that there is a conserved, yet flexible, cullin recognition module and that cullin selectivity is influenced by distinct electrostatic interactions. Our structure provides a structural basis for the study of the pathogenesis of VHL disease and rationale for the design of novel compounds that may modulate cullin-substrate receptor interactions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Study Healthy Ageing and Intellectual Disabilities: Recruitment and Design

ERIC Educational Resources Information Center

Hilgenkamp, Thessa I. M.; Bastiaanse, Luc P.; Hermans, Heidi; Penning, Corine; van Wijck, Ruud; Evenhuis, Heleen M.

2011-01-01

Problems encountered in epidemiologic health research in older adults with intellectual disabilities (ID) are how to recruit a large-scale sample of participants and how to measure a range of health variables in such a group. This cross-sectional study into healthy ageing started with founding a consort of three large care providers with a total…

A randomized trial of blood donor recruitment strategies.

PubMed

Reich, Pascale; Roberts, Paula; Laabs, Nancy; Chinn, Artina; McEvoy, Patrick; Hirschler, Nora; Murphy, Edward L

2006-07-01

Improvement in donor return rates, especially among first-time donors, may significantly improve the blood supply. There are few rigorous studies of the effectiveness of various approaches to donor recruitment, however. By use of a single-blind, randomized trial design, 6919 post-September 11, 2001, first-time donors were randomly assigned into the following intervention arms: T-shirt incentive versus none, recruitment scripts with a patient story (Script A) versus a complimentary message including the donor's blood type (Script B), and telephone versus e-mail recruitment. Our primary outcome was a second donation within 6 months. Rate ratios (RRs) and 95 percent confidence intervals (95% CIs) were calculated with Taylor series methods. A total of 1421 (20.5%) first-time donors returned within the 6 months, including 1252 with a second and 169 with both second and third donations. The T-shirt incentive was not effective in increasing returns compared to no incentive (20.5% vs. 20.6%; RR, 0.99; 95% CI, 0.91-1.09). Script A was significantly more effective than Script B (22.2% vs. 18.9%; RR, 1.18; 95% CI, 1.07-1.29). E-mail was substantially less effective than telephone recruitment (13.2% vs. 27.8%; RR, 0.48; 95% CI, 0.40-0.57). A T-shirt incentive had no apparent effect, but an empathetic message significantly improved the return donation rate. E-mail recruitment was substantially less effective than telephone recruitment, perhaps due to technical problems. The study illustrates the utility of the randomized clinical trial study design for testing donor recruitment strategies.

Recruiting for Caregiver Education Research

PubMed Central

Finlayson, Marcia; Henkel, Christin

2012-01-01

Caregiver education programs can support participants in a role that is often challenging. Research is needed to determine the effectiveness of these programs; however, recruitment for such studies can be difficult. The objectives of this study were to explore 1) how multiple sclerosis (MS) caregivers respond to recruitment materials for a research study evaluating a caregiver education program, including aspects of the materials that encourage or discourage their interest in participation; and 2) what recommendations MS caregivers have for improving study recruitment advertising. Qualitative interviews were conducted with seven MS caregivers. Participants were asked about their reactions to advertisements for a pilot study intended to evaluate an MS caregiver education program. Participants were also asked to reflect on factors that would influence their decision to participate in the program and to provide suggestions to improve recruitment materials. Data were analyzed using a constant-comparative approach. Study findings indicated that the language and visual design of the advertisements influenced the participants' initial responses. Some caregivers first responded to the fact that the program was part of a research study, and these caregivers had overall negative responses to the advertising, such as concern that the program was being “tested.” Other caregivers first considered the personal relevance of the program. These caregivers had neutral-to-positive responses to the flyers and weighed the relevance of the program against the research and logistical aspects. Participants provided recommendations to improve the recruitment materials. While recruiting for caregiver education research can be challenging, piloting recruitment materials and using a variety of advertising options may improve response. PMID:24453751

Rationale and Design of the Feeding Dynamic Intervention (FDI) Study for Self-Regulation of Energy Intake in Preschoolers

PubMed Central

Eneli, Ihuoma U.; Tylka, Tracy L.; Hummel, Jessica; Watowicz, Rosanna P.; Perez, Susana A.; Kaciroti, Niko; Lumeng, Julie C.

2015-01-01

In 2011, the Institute of Medicine Early Childhood Prevention Policies Report identified feeding dynamics as an important focus area for childhood obesity prevention and treatment. Feeding dynamics include two central components: (1) caregiver feeding practices (i.e., determining how, when, where, and what they feed their children) and (2) child eating behaviors (i.e., determining how much and what to eat from what food caregivers have provided). Although there has been great interest in overweight and obesity prevention and treatment in young children, they have not focused comprehensively on feeding dynamics. Interventions on feeding dynamics that reduce caregivers’ excessive controlling and restrictive feeding practices and encourage the development of children’s self-regulation of energy intake may hold promise for tackling childhood obesity especially in the young child but currently lack an evidence base. This manuscript describes the rationale and design for a randomized controlled trial designed to compare a group of mothers and their 3-to 5-year old children who received an intervention focused primarily on feeding dynamics called the Feeding Dynamic Intervention (FDI) with a Wait-list Control Group (WLC). The primary aim of the study will be to investigate the efficacy of the FDI for decreasing Eating in the Absence of Hunger (EAH) and improving energy compensation (COMPX). The secondary aim will be to examine the effect of the FDI in comparison to the WLC on maternal self-reported feeding practices and child satiety responsiveness. PMID:25616192

Rationale and design of Mi-CARE: The mile square colorectal cancer screening, awareness and referral and education project.

PubMed

Buscemi, Joanna; Miguel, Yazmin San; Tussing-Humphreys, Lisa; Watts, Elizabeth A; Fitzgibbon, Marian L; Watson, Karriem; Winn, Robert A; Matthews, Kameron L; Molina, Yamile

2017-01-01

Although colorectal cancer (CRC) is largely preventable through identification of pre-cancerous polyps through various screening modalities, morbidity and mortality rates remain a challenge, especially in African-American, Latino, low-income and uninsured/underinsured patients. Barriers to screening include cost, access to health care facilities, lack of recommendation to screen, and psychosocial factors such as embarrassment, fear of the test, anxiety about testing preparation and fear of a cancer diagnosis. Various intervention approaches to improve CRC screening rates have been developed. However, comparative effectiveness research (CER) to investigate the relative performance of different approaches has been understudied, especially across different real-life practice settings. Assessment of differential efficacy across diverse vulnerable populations is also lacking. The current paper describes the rationale and design for the Mile Square Colorectal Cancer Screening, Awareness and Referral and Education Project (Mi-CARE), which aims to increase CRC screening rates in 3 clinics of a large Federally Qualified Health Center (FQHC) by reducing prominent barriers to screening for low-income, minority and underserved patients. Patients attending these clinics will receive one of three interventions to increase screening uptake: lay patient navigator (LPN)-based navigation, provider level navigation, or mailed birthday CRC screening reminders. The design of our program allows for comparison of the effectiveness of the tailored interventions across sites and patient populations. Data from Mi-CARE may help to inform the dissemination of tailored interventions across FQHCs to reduce health disparities in CRC. Copyright © 2016 Elsevier Inc. All rights reserved.

Improving recruitment into geriatric medicine in Canada: Findings and recommendations from the geriatric recruitment issues study.

PubMed

Torrible, Susan J; Diachun, Laura L; Rolfson, Darryl B; Dumbrell, Andrea C; Hogan, David B

2006-09-01

As the number of Canadians aged 65 and older continues to increase, declining recruitment into geriatric medicine (GM) raises concerns about the future viability of this medical subspecialty. To develop effective strategies to attract more GM trainees into the field, it is necessary to understand how medical students, residents, GM trainees, and specialists make career choices. The Geriatric Recruitment Issues Study (GRIST) was designed to assess specific methods that could be used to improve recruitment into geriatrics in Canada. Between November 2002 and January 2003, 530 participants were invited to complete the GRIST survey (117 Canadian geriatricians, 12 GM trainees, 96 internal medicine residents, and 305 senior medical students). Two hundred fifty-three surveys (47.7%) were completed and returned (from 54 participating geriatricians, 9 GM trainees, 50 internal medicine residents, and 140 senior medical students). The survey asked respondents to rate factors influencing their choice of medical career, the attractiveness of GM, and the anticipated effectiveness of potential recruitment strategies. Although feedback varied across the four groups on these issues, consistencies were observed between medical students and residents and between GM trainees and geriatricians. All groups agreed that role modeling was effective and that summer student research programs were an ineffective recruitment strategy. Based on the GRIST findings, this article proposes six recommendations for improving recruitment into Canadian geriatric medicine training programs.

Institutional and Managerial Factors Affecting International Student Recruitment Management

ERIC Educational Resources Information Center

Ross, Mitchell; Heaney, Joo-Gim; Cooper, Maxine

2007-01-01

Purpose: The purpose of this paper is to investigate international student recruitment from an institutional perspective and to consider institutional factors that may affect recruitment. Design/methodology/approach: A qualitative study is undertaken in which education marketing practitioners are interviewed regarding aspects of international…

Designing the Future: The Recruitment Connection. Summary of Proceedings (Orlando, Florida, February 12-14, 1988).

ERIC Educational Resources Information Center

American Dental Hygienists' Association, Chicago, IL.

A summary of the proceedings from a hygienists' conference is presented. Papers are as follows: "Career Recruitment: A Vested Interest" (Marge Reveal); "Partners in Career Recruitment" (Sharon Kershaw); "Educational Structure: Its Role in Career Recruitment" (Sarah Turner); "Communicating Our Professional Goals" (Connie Tussing); "Career…

The "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study: Rationale, design and methods.

PubMed

Calvani, Riccardo; Picca, Anna; Marini, Federico; Biancolillo, Alessandra; Cesari, Matteo; Pesce, Vito; Lezza, Angela Maria Serena; Bossola, Maurizio; Leeuwenburgh, Christiaan; Bernabei, Roberto; Landi, Francesco; Marzetti, Emanuele

2018-05-10

Sarcopenia, the progressive and generalised loss of muscle mass and strength/function, is a major health issue in older adults given its high prevalence and burdensome clinical implications. Over the years, this condition has been endorsed as a marker for discriminating biological from chronological age. However, the absence of a unified operational definition has hampered its full appreciation by healthcare providers, researchers and policy-makers. In addition to this unsolved debate, the complexity of musculoskeletal ageing represents a major challenge to the identification of clinically meaningful biomarkers. Here, we illustrate the advantages of biomarker discovery procedures in muscle ageing based on multivariate methodologies as an alternative approach to traditional single-marker strategies. The rationale, design and methods of the "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study are described as an application of a multi-marker strategy for the development of biomarkers for the newly operationalised Physical Frailty & Sarcopenia condition. Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

BiomarCaRE: rationale and design of the European BiomarCaRE project including 300,000 participants from 13 European countries.

PubMed

Zeller, Tanja; Hughes, Maria; Tuovinen, Tarja; Schillert, Arne; Conrads-Frank, Annette; Ruijter, Hester den; Schnabel, Renate B; Kee, Frank; Salomaa, Veikko; Siebert, Uwe; Thorand, Barbara; Ziegler, Andreas; Breek, Heico; Pasterkamp, Gerard; Kuulasmaa, Kari; Koenig, Wolfgang; Blankenberg, Stefan

2014-10-01

Biomarkers are considered as tools to enhance cardiovascular risk estimation. However, the value of biomarkers on risk estimation beyond European risk scores, their comparative impact among different European regions and their role towards personalised medicine remains uncertain. Biomarker for Cardiovascular Risk Assessment in Europe (BiomarCaRE) is an European collaborative research project with the primary objective to assess the value of established and emerging biomarkers for cardiovascular risk prediction. BiomarCaRE integrates clinical and epidemiological biomarker research and commercial enterprises throughout Europe to combine innovation in biomarker discovery for cardiovascular disease prediction with consecutive validation of biomarker effectiveness in large, well-defined primary and secondary prevention cohorts including over 300,000 participants from 13 European countries. Results from this study will contribute to improved cardiovascular risk prediction across different European populations. The present publication describes the rationale and design of the BiomarCaRE project.

Academic plastic surgery: faculty recruitment and retention.

PubMed

Chen, Jenny T; Girotto, John A; Kitzmiller, W John; Lawrence, W Thomas; Verheyden, Charles N; Vedder, Nicholas B; Coleman, John J; Bentz, Michael L

2014-03-01

A critical element of a thriving academic plastic surgery program is the quality of faculty. A decline in recruitment and retention of faculty has been attributed to the many challenges of academic medicine. Given the substantial resources required to develop faculty, academic plastic surgery has a vested interest in improving the process of faculty recruitment and retention. The American Council of Academic Plastic Surgeons Issues Committee and the American Society of Plastic Surgeons/Plastic Surgery Foundation Academic Affairs Council surveyed the 83 existing programs in academic plastic surgery in February of 2012. The survey addressed the faculty-related issues in academic plastic surgery programs over the past decade. Recruitment and retention strategies were evaluated. This study was designed to elucidate trends, and define best strategies, on a national level. Academic plastic surgery programs have added substantially more full-time faculty over the past decade. Recruitment efforts are multifaceted and can include guaranteed salary support, moving expenses, nurse practitioner/physician's assistant hires, protected time for research, seed funds to start research programs, and more. Retention efforts can include increased compensation, designation of a leadership appointment, protected academic time, and call dilution. Significant change and growth of academic plastic surgery has occurred in the past decade. Effective faculty recruitment and retention are critical to a successful academic center. Funding sources in addition to physician professional fees (institutional program support, grants, contracts, endowment, and so on) are crucial to sustain the academic missions.

Design, Recruitment and Start Up of a Primary Care Weight Loss Trial Targeting African American and Hispanic Adults

PubMed Central

Kumanyika, Shiriki; Fassbender, Jennifer; Phipps, Etienne; Tan-Torres, Susan; Localio, Russell; Morales, Knashawn H.; Sarwer, David B.; Harralson, Tina; Allison, Kelly; Wesby, Lisa; Kessler, Ronni; Tsai, Adam Gilden; Wadden, Thomas A.

2011-01-01

Primary care offices are critical access points for obesity treatment, but evidence for approaches that can be implemented within these settings is limited. The Think Health! (¡Vive Saludable!) Study was designed to assess the feasibility and effectiveness of a behavioral weight loss program, adapted from the Diabetes Prevention Program, for implementation in routine primary care. Recruitment of clinical sites targeted primary care practices serving African American and Hispanic adults. The randomized design compares (a) a moderate-intensity treatment consisting of primary care provider counseling plus additional counseling by an auxiliary staff member (i.e., lifestyle coach), with (b) a low-intensity, control treatment involving primary care provider counseling only. Treatment and follow up duration are 1 to 2 years. The primary outcome is weight change from baseline at 1 and 2 years post-randomization. Between November 2006 and January 2008, 14 primary care providers (13 physicians; 1 physician assistant) were recruited at five clinical sites. Patients were recruited between October 2007 and November 2008. A total of 412 patients were pre-screened, of whom 284 (68.9%) had baseline assessments and 261 were randomized, with the following characteristics: 65% African American; 16% Hispanic American; 84% female; mean (SD) age of 47.2 (11.7) years; mean (SD) BMI of 37.2(6.4) kg/m2; 43.7% with high blood pressure; and 18.4% with diabetes. This study will provide insights into the potential utility of moderate-intensity lifestyle counseling delivered by motivated primary care clinicians and their staff. The study will have particular relevance to African Americans and women. PMID:21062645

Overall Rationale and Design of Study.

ERIC Educational Resources Information Center

Hegsted, D. Mark

This paper outlines research designed to establish dietary correlates of malnutrition, and questions the common assumption that high protein foods should be used as dietary supplements in humans. Because thorough investigation of dietary needs in children is ethically unfeasible, squirrel monkeys were used in the research to study the biological…

Challenges in recruitment and retention of clinical trial subjects.

PubMed

Kadam, Rashmi Ashish; Borde, Sanghratna Umakant; Madas, Sapna Amol; Salvi, Sundeep Santosh; Limaye, Sneha Saurabh

2016-01-01

Successful recruitment of patients is known to be one of the most challenging aspects in conduct of randomized controlled trials. Inadequate patient retention during conduct of trial affects conclusive results. To assess the level of challenges faced by Indian investigators in recruitment and retention of trial subjects. We developed a survey questionnaire on challenges encountered by investigators in subject recruitment and retention which was hosted on a web portal. Seventy-three investigators from India participated in the survey. The frequently encountered challenges in subject recruitment were complexity of study protocol (38%), lack of awareness about clinical trials in patients (37%), and sociocultural issues related to trial participation (37%). About 63% of participants strongly agreed that creating a positive awareness about clinical trials among people through press and media, having a dedicated clinical research coordinator for trial (50.7%), and designing a recruitment strategy prior to study initiation (46.6%) would enhance recruitment. Almost 50.7% of participants agreed that interacting with medical community in vicinity of the study site and educating patients about clinical trials during routine outpatient department visits (46.6%) would enhance recruitment. Experiencing a serious adverse event, subject's fear for study procedures (47%) and side effects (44%) were thought to have a moderate effect on subject retention. Our survey has put forth factors related to negative publicity by media, lack of patient education about clinical trials; complex study designs are barriers to clinical trial recruitment in India. It is essential to devise innovative and effective strategies focusing on education of public and mass media about clinical research in India.

Issues of Recruitment and Rationale for Conducting Clinical Trials on Mutans Streptococci Suppression in Mothers

PubMed Central

Bretz, Walter A.; Rosa, Odila P. S.; Silva, Salete M. B.; Corby, Patricia; Weissfeld, Lisa; Loesche, Walter J.

2010-01-01

The aims of this study are (1) to describe issues related to recruitment of mothers participating in a clinical trial of transmission of mutans streptococci (MS) from mother to child in Bauru, Brazil and (2) to perform cross-cultural and temporal comparisons of levels of infection of the MS in mothers of Bauru. A total of 1422 mothers were visited at their domiciles. Cutoff levels for the MS were established at ≥105 CFU/mL saliva. The main reason for a mother not enrolling was not being highly infected by the MS, yet 76% of mothers presented with levels ≥105 CFU/mL saliva. Recent studies in industrialized countries showed a negative coefficient for linear tests indicating significant decline overtime in the levels of MS in mothers. Intercountry comparisons for mothers' salivary levels of the MS with the Bauru study as the reference revealed significant differences with studies conducted in the last two decades. PMID:20827385

A community based prevention of weight gain intervention (Mothers In Motion) among young low-income overweight and obese mothers: design and rationale.

PubMed

Chang, Mei-Wei; Nitzke, Susan; Brown, Roger; Resnicow, Ken

2014-03-25

Over 45% of American women 20-39 years old are at risk for type 2 diabetes, cardiovascular disease, and other health conditions because they are overweight or obese. The prevalence of overweight and obesity is disproportionately high among low-income women. This paper describes the study design and rationale of a community based intervention (Mothers In Motion, MIM) aimed to prevent weight gain among low-income overweight and obese mothers 18-39 years old by promoting stress management, healthy eating, and physical activity. Peer recruiters approach participants from 5 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Michigan. The MIM delivers theory-based, culturally-sensitive intervention messages via a combination of DVDs and peer support group teleconferences (PSGTs). The DVD features African American and white overweight and obese WIC mothers who participated in a healthy lifestyle intervention patterned after MIM. The PSGTs are led by paraprofessionals from Michigan State University Extension and WIC providers in Michigan who are trained in motivational interviewing and group facilitation skills. Participants are randomly assigned to an intervention (n=350) or comparison group (n=175). The intervention group receives a 16-week intervention on a weekly or bi-weekly basis. Participants are asked to watch 10 MIM DVD chapters at home and join 10 PSGT sessions by phone. The comparison group receives printed educational materials. The primary outcome is body weight. Secondary outcomes include dietary fat, fruit, and vegetable intake; physical activity; stress, and affect. Mediators are self-efficacy, emotional coping response, social support, and autonomous motivation. Telephone interviews and in-person data collection at WIC offices occur at 3 time points: baseline, immediately, and 3 months after the 16-week intervention. If MIM shows effectiveness, it could have a favorable impact on public health and community programs. The DVDs

The Students-Recruiting-Students Undergraduate Engineering Recruiting Programme.

ERIC Educational Resources Information Center

Gattis, Carol; Nachtmann, Heather; Youngblood, Alisha D.

2003-01-01

Describes the Students-Recruiting-Students (SRS) program developed to recruit high school students into the Industrial Engineering Department at the University of Arkansas. Presents four phases of the program along with seven years of program results. Encourages successful development of similar recruiting programs. (KHR)

Recruitment/Selectors' Perceptions of Male and Female Trainee Managers

ERIC Educational Resources Information Center

Kniveton, Bromley H.

2008-01-01

Purpose: The aim of this paper is to investigate whether those involved with recruitment/selection (RS) react differently towards male and female trainee managers. Design/methodology/approach: Measures of the perceptions towards trainee managers were collected from 440 managers and professionals involved in recruitment/selection (RS). Findings: It…

Applying Semiotic Theories to Graphic Design Education: An Empirical Study on Poster Design Teaching

ERIC Educational Resources Information Center

Yang, Chao-Ming; Hsu, Tzu-Fan

2015-01-01

The rationales behind design are dissimilar to those behind art. Establishing an adequate theoretical foundation for conducting design education can facilitate scientising design methods. Thus, from the perspectives of the semiotic theories proposed by Saussure and Peirce, we investigated graphic design curricula by performing teaching…

Nurse forecasting in Europe (RN4CAST): Rationale, design and methodology

PubMed Central

2011-01-01

Background Current human resources planning models in nursing are unreliable and ineffective as they consider volumes, but ignore effects on quality in patient care. The project RN4CAST aims innovative forecasting methods by addressing not only volumes, but quality of nursing staff as well as quality of patient care. Methods/Design A multi-country, multilevel cross-sectional design is used to obtain important unmeasured factors in forecasting models including how features of hospital work environments impact on nurse recruitment, retention and patient outcomes. In each of the 12 participating European countries, at least 30 general acute hospitals were sampled. Data are gathered via four data sources (nurse, patient and organizational surveys and via routinely collected hospital discharge data). All staff nurses of a random selection of medical and surgical units (at least 2 per hospital) were surveyed. The nurse survey has the purpose to measure the experiences of nurses on their job (e.g. job satisfaction, burnout) as well as to allow the creation of aggregated hospital level measures of staffing and working conditions. The patient survey is organized in a sub-sample of countries and hospitals using a one-day census approach to measure the patient experiences with medical and nursing care. In addition to conducting a patient survey, hospital discharge abstract datasets will be used to calculate additional patient outcomes like in-hospital mortality and failure-to-rescue. Via the organizational survey, information about the organizational profile (e.g. bed size, types of technology available, teaching status) is collected to control the analyses for institutional differences. This information will be linked via common identifiers and the relationships between different aspects of the nursing work environment and patient and nurse outcomes will be studied by using multilevel regression type analyses. These results will be used to simulate the impact of changing

Secondary School Students Learning from Reflections on the Rationale behind Self-Made Errors: A Field Experiment

ERIC Educational Resources Information Center

Heemsoth, Tim; Heinze, Aiso

2016-01-01

Thus far, it is unclear how students can learn most effectively from their own errors. In this study, reflections on the rationale behind self-made errors are assumed to enhance knowledge acquisition. In a field experiment with pre/post/follow-up design, the authors practiced fractions with 174 seventh- and eighth-grade students who were randomly…

Moral and Instrumental Rationales for Affirmative Action in Five National Contexts

ERIC Educational Resources Information Center

Moses, Michele S.

2010-01-01

The author's primary aims are to clarify the differing rationales for affirmative action that have emerged in five nations--France, India, South Africa, the United States, and Brazil--and to make the case for the most compelling rationales, whether instrumentally or morally based. She examines the different social contexts surrounding the…

Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE-AF) randomized trial: Design and rationale.

PubMed

Bernstein, Richard A; Kamel, Hooman; Granger, Christopher B; Kowal, Robert C; Ziegler, Paul D; Schwamm, Lee H

2017-08-01

Approximately 20% of ischemic strokes are associated with clinically apparent atrial fibrillation (AF). Regardless of stroke etiology, detection of AF in patients with ischemic strokes often changes antithrombotic treatment from anti-platelet to oral anticoagulation therapy. The role and the optimum duration of cardiac monitoring to detect AF in patients with strokes presumed due to large vessel atherosclerosis or small vessel disease is unknown. This manuscript describes the design and rationale of the STROKE-AF trial. STROKE-AF is a randomized, controlled, open-label, post-market clinical trial. Detection of AF will be evaluated using continuous arrhythmia monitoring with an insertable cardiac monitor (ICM) compared with standard of care follow-up in patients with stroke (within the prior 10 days) that is presumed due to large vessel cervical or intracranial atherosclerosis, or to small vessel disease. Approximately 500 patients will be enrolled at approximately 40 centers in the United States. Patients will be randomized 1:1 to arrhythmia monitoring with an ICM (continuous monitoring arm) or standard of care follow-up (control arm). Subjects will be followed for ≥12 months and up to 3 years. The primary objective is to compare the incidence rate of detected AF through 12 months of follow-up between the two arms. This trial will provide information on the value of ICMs to detect subclinical AF in patients with stroke presumed due to large vessel atherosclerosis or small vessel disease, which will have implications for guiding treatment with oral anticoagulation for secondary stroke prevention. Copyright © 2017 Elsevier Inc. All rights reserved.

ADA Integrated Environment I. Design Rationale.

DTIC Science & Technology

1981-12-01

integration and integrated communications are evidenced across data, control and development concepts. STONEMAN [STONEMAN] and the S.O.W. suggest a layered...their managers, but others as well. During development , ongoing communication must be maintained with system specifiers and designers, hardware engineers...reorganization as a result of organizational change or of technology insertion. Consequently, current MAPSE development must be viewed in the context of

Public financing of IVF: a review of policy rationales.

PubMed

Mladovsky, Philipa; Sorenson, Corinna

2010-06-01

There is great diversity in in vitro fertilization (IVF) funding and reimbursement policies and practice throughout Europe and the rest of the world. While many existing reimbursement and regulatory frameworks address safety and legal concerns, economic factors also assume a central role. However, there are several problems with the evidence that is available on the economics of IVF. This suggests there is a need for more robust cost-effectiveness studies. It also indicates the need for alternative rationales to justify the reimbursement of IVF, which might more fully account for the social, political, ethical, and philosophical considerations embedded in notions of infertility and technology-driven reproductive treatments. The merits and limitations of five alternative rationales are discussed. The review suggests that while no existing single rationale provides a complete framework with which to support funding decisions, taken together they provide guideposts which signal important issues for consideration and highlight where further research, action, and debate are needed.

Actuarial analysis of surgical results: rationale and method.

PubMed

Grunkemeier, G L; Starr, A

1977-11-01

The use of time-related methods of statistical analysis is essential for valid evaluation of the long-term results of a surgical procedure. Accurate comparison of two procedures or two prosthetic devices is possible only when the length of follow-up is properly accounted for. The purpose of this report is to make the technical aspects of the acturial, or life table, method easily accessible to the surgeon, with emphasis on the motivation for and the rationale behind it. This topic is illustrated in terms of heart valve prostheses, a field that is rapidly developing. Both the authors and readers of articles must be aware that controversies surrounding the relative merits of various prosthetic designs or operative procedures can be settled only if proper time-related methods of analysis are utilized.

Attitudes towards Affirmative Action: Effects of Procedural Rationale and Candidates' Qualifications.

ERIC Educational Resources Information Center

Mann, Jeffrey A.; Fasolo, Peter M.

This study examined whether individuals in higher education who are exposed to a hiring rationale based on a diversity value (minority group differences are valuable and should be relevant criteria for employment decisions in higher education) will rate affirmative action as fairer than those exposed to a compensation rationale (minority status is…

Recruitment and retention of rural African Americans in diabetes research: lessons learned.

PubMed

Loftin, Wanda Anderson; Barnett, Steven K; Bunn, Peggy Summers; Sullivan, Patra

2005-01-01

The purpose of this article was to describe lessons learned about recruitment and retention of rural African Americans from published literature, the authors' research, and research experience. Two rural, community-based research studies with African Americans with diabetes are used to illustrate different issues and strategies in recruitment and retention. Relevant MEDLINE articles and clinical studies were reviewed, and the design, implementation, and results of the 2 community-based studies were evaluated. Information from the literature, research results, and sample selection, participation, and attrition experiences were synthesized to determine effective approaches for recruitment and retention. Research funding, design, and implementation; recruitment methods; culturally competent approaches; caring, trusting provider-patient relationships; incentives; follow-up; and factors in the rural environment emerged as important issues influencing recruitment and retention. Recruitment and retention of African Americans in rural diabetes research is a significant challenge, and adequate funding should be sought early in the research process. Culturally competent approaches; caring, trusting relationships; incentives; and follow-up are important concepts in successful recruitment, participation, and retention of African Americans. The lessons learned may be applicable to the more widespread issue of recruitment and retention of rural African Americans in diabetes education programs.

Recruiting medical students to rural practice

PubMed Central

Jutzi, Leah; Vogt, Kelly; Drever, Erin; Nisker, Jeff

2009-01-01

ABSTRACT OBJECTIVE To explore the strategies used by rural recruitment programs and their perceived influence on medical students. DESIGN Two original questionnaires delivered electronically, one to medical students and the other to recruiters in rural Ontario communities. SETTING Ontario, Canada. PARTICIPANTS All 525 medical students enrolled in the Schulich School of Medicine & Dentistry at the University of Western Ontario in London and physician recruiters in 71 rural communities in Ontario were invited to participate in the study. MAIN OUTCOME MEASURES The factors that influence medical students to consider rural practice, strategies used by recruiters, and student perceptions of the ethical appropriateness of both. RESULTS The questionnaire was completed by 42.1% of medical students. Lifestyle considerations were an important influence for 93.1% of students. Themes from the qualitative analysis included the ethical appropriateness of financial considerations, economic forces, perceived disadvantages of rural practice, competition between communities, and lack of altruism. Responses were received from recruiters in 43.7% of communities; of those, 92.9% offered financial incentives to attract prospective physicians. CONCLUSION Financial and lifestyle considerations are important influences on medical students’ choice to practise in rural communities. Most medical students felt incentive programs offered by rural communities were ethically appropriate. PMID:19155375

Recruitment Gaming: A New Tool at the Interface of Education and Employers

ERIC Educational Resources Information Center

Porter, Gavin W.; Tanenbaum, Michael A.

2015-01-01

Recruitment gaming embodies an exciting new tool at the interface of the education and private sectors. Employers and recruitment platforms add new complications to the already problematic relationship between game designers and educators. To better understand the emerging recruitment aspects of gaming and identify areas for those in educational…

Effective recruitment strategies in primary care research: a systematic review.

PubMed

Ngune, Irene; Jiwa, Moyez; Dadich, Ann; Lotriet, Jaco; Sriram, Deepa

2012-01-01

Patient recruitment in primary care research is often a protracted and frustrating process, affecting project timeframes, budget and the dissemination of research findings. Yet, clear guidance on patient recruitment strategies in primary care research is limited. This paper addresses this issue through a systematic review. Articles were sourced from five academic databases - AustHealth, CINAHL, the Cochrane Methodology Group, EMBASE and PubMed/Medline; grey literature was also sourced from an academic library and the Primary Healthcare Research & Information Service (PHCRIS) website. Two reviewers independently screened the articles using the following criteria: (1) published in English, (2) reported empirical research, (3) focused on interventions designed to increase patient recruitment in primary care settings, and (4) reported patient recruitment in primary care settings. Sixty-six articles met the inclusion criteria. Of these, 23 specifically focused on recruitment strategies and included randomised trials (n = 7), systematic reviews (n = 8) and qualitative studies (n = 8). Of the remaining articles, 30 evaluated recruitment strategies, while 13 addressed the value of recruitment strategies using descriptive statistics and/or qualitative data. Among the 66 articles, primary care chiefly included general practice (n = 30); nursing and allied health services, multiple settings, as well as other community settings (n = 30); and pharmacy (n = 6). Effective recruitment strategies included the involvement of a discipline champion, simple patient eligibility criteria, patient incentives and organisational strategies that reduce practitioner workload. The most effective recruitment in primary care research requires practitioner involvement. The active participation of primary care practitioners in both the design and conduct of research helps to identify strategies that are congruent with the context in which patient care is delivered. This is reported to be the

Designing a physical activity parenting course: Parental views on recruitment, content and delivery

PubMed Central

2012-01-01

Background Many children do not engage in sufficient levels of physical activity (PA) and spend too much time screen-viewing (SV). High levels of SV (e.g. watching TV, playing video games and surfing the internet) and low levels of PA have been associated with adverse health outcomes. Parenting courses may hold promise as an intervention medium to change children’s PA and SV. The current study was formative work conducted to design a new parenting programme to increase children’s PA and reduce their SV. Specifically, we focussed on interest in a course, desired content and delivery style, barriers and facilitators to participation and opinions on control group provision. Methods In-depth telephone interviews were conducted with thirty two parents (29 female) of 6–8 year olds. Data were analysed thematically. An anonymous online survey was also completed by 750 parents of 6–8 year old children and descriptive statistics calculated. Results Interview participants were interested in a parenting course because they wanted general parenting advice and ideas to help their children be physically active. Parents indicated that they would benefit from knowing how to quantify their child’s PA and SV levels. Parents wanted practical ideas of alternatives to SV. Most parents would be unable to attend unless childcare was provided. Schools were perceived to be a trusted source of information about parenting courses and the optimal recruitment location. In terms of delivery style, the majority of parents stated they would prefer a group-based approach that provided opportunities for peer learning and support with professional input. Survey participants reported the timing of classes and the provision of childcare were essential factors that would affect participation. In terms of designing an intervention, the most preferred control group option was the opportunity to attend the same course at a later date. Conclusions Parents are interested in PA/SV parenting

Designing a physical activity parenting course: parental views on recruitment, content and delivery.

PubMed

Jago, Russell; Steeds, Joanna K; Bentley, Georgina F; Sebire, Simon J; Lucas, Patricia J; Fox, Kenneth R; Stewart-Brown, Sarah; Turner, Katrina M

2012-07-05

Many children do not engage in sufficient levels of physical activity (PA) and spend too much time screen-viewing (SV). High levels of SV (e.g. watching TV, playing video games and surfing the internet) and low levels of PA have been associated with adverse health outcomes. Parenting courses may hold promise as an intervention medium to change children's PA and SV. The current study was formative work conducted to design a new parenting programme to increase children's PA and reduce their SV. Specifically, we focussed on interest in a course, desired content and delivery style, barriers and facilitators to participation and opinions on control group provision. In-depth telephone interviews were conducted with thirty two parents (29 female) of 6-8 year olds. Data were analysed thematically. An anonymous online survey was also completed by 750 parents of 6-8 year old children and descriptive statistics calculated. Interview participants were interested in a parenting course because they wanted general parenting advice and ideas to help their children be physically active. Parents indicated that they would benefit from knowing how to quantify their child's PA and SV levels. Parents wanted practical ideas of alternatives to SV. Most parents would be unable to attend unless childcare was provided. Schools were perceived to be a trusted source of information about parenting courses and the optimal recruitment location. In terms of delivery style, the majority of parents stated they would prefer a group-based approach that provided opportunities for peer learning and support with professional input. Survey participants reported the timing of classes and the provision of childcare were essential factors that would affect participation. In terms of designing an intervention, the most preferred control group option was the opportunity to attend the same course at a later date. Parents are interested in PA/SV parenting courses but the provision of child care is essential

Why Do Higher Education Institutions Internationalize? An Investigation of the Multilevel Determinants of Internationalization Rationales

ERIC Educational Resources Information Center

Seeber, Marco; Cattaneo, Mattia; Huisman, Jeroen; Paleari, Stefano

2016-01-01

In recent decades internationalization has risen to prominence in higher education institutions (HEIs). Scholars have identified several rationales for internationalization. There is however a lack of conceptual understanding and empirical evidence for which rationale(s) for internationalization are chosen by a given HEI and why. The goal of this…

Universal Playground Design.

ERIC Educational Resources Information Center

Ensign, Arselia, Ed.

1993-01-01

This publication presents principles of universal playgrounds, designed to maximize accessibility for all children, with and without disabilities. First, the rationale for the universal playground is given including the importance of play and the value of integration. Next current guidelines for playground design are discussed including safety,…

Engendering healthy masculinities to prevent sexual violence: Rationale for and design of the Manhood 2.0 trial.

PubMed

Abebe, Kaleab Z; Jones, Kelley A; Culyba, Alison J; Feliz, Nayck B; Anderson, Heather; Torres, Irving; Zelazny, Sarah; Bamwine, Patricia; Boateng, Adwoa; Cirba, Benjamin; Detchon, Autumn; Devine, Danielle; Feinstein, Zoe; Macak, Justin; Massof, Michael; Miller-Walfish, Summer; Morrow, Sarah Elizabeth; Mulbah, Paul; Mulwa, Zabi; Paglisotti, Taylor; Ripper, Lisa; Ports, Katie A; Matjasko, Jennifer L; Garg, Aapta; Kato-Wallace, Jane; Pulerwitz, Julie; Miller, Elizabeth

2018-05-23

Violence against women and girls is an important global health concern. Numerous health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health prevention strategy. Adapted from an international setting for use in the US, "Manhood 2.0" is a "gender transformative" program that involves challenging harmful gender and sexuality norms that foster violence against women while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce the perpetration of sexual violence (SV) and adolescent relationship abuse (ARA). Manhood 2.0 is being rigorously evaluated in a community-based cluster-randomized trial in 21 lower resource Pittsburgh neighborhoods with 866 adolescent males ages 13-19. The comparison intervention is a job readiness training program which focuses on the skills needed to prepare youth for entering the workforce, including goal setting, accountability, resume building, and interview preparation. This study will provide urgently needed information about the effectiveness of a gender transformative program, which combines healthy sexuality education, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males. In this manuscript, we outline the rationale for and evaluation design of Manhood 2.0. Clinical Trials #: NCT02427061. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

ProsLab -- A Method for Pretesting Printed Army Recruiting Advertisements.

DTIC Science & Technology

1973-05-01

The principal objective of this report was to design and implement a printed advertising pretest prototype facility for the U. S. Army Recruiting...related to ad response and enlistment. A total of 29 recruiting magazine advertisements were evaluated; each of these ads had been printed in several

Impact of study design on recruitment of patients to a primary care trial: an observational time series analysis of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study.

PubMed

Fletcher, K; Mant, J; Roalfe, A; Hobbs, F D R

2010-12-01

recruitment targets to randomized controlled trials (RCTs) are often not met. Many interventions are used to improve recruitment but there is little empirical evidence on whether these approaches work. to examine whether changes to the design and conduct of a primary care-based RCT were associated with changes in patient recruitment. an observational time series analysis of recruitment to a primary care-based multi-centre RCT of aspirin versus warfarin for stroke prevention, which involved 330 practices. Several changes to the trial protocol and procedures were made over the 4 years of patient recruitment. For each quarter throughout the recruitment period, the recruitment rate per 1000 total population in active practices was calculated. the recruitment target of 930 patients was exceeded. Fluctuations in recruitment rate occurred during the recruitment period. Following protocol changes aimed to reduce clinical workload, there was a significant increase in recruitment during the final 6 months of the study, during a period when there was not a similarly large increase in the total population available. these findings suggest that the conduct of a trial is an important consideration if studies are to recruit successfully. Expanding the number of centres may not be the most effective way to improve recruitment.

Training for Corrections: Rationale and Techniques.

ERIC Educational Resources Information Center

Southern Illinois Univ., Carbondale. Center for the Study of Crime, Delinquency and Corrections.

A manual focuses on how to teach in inservice training programs for professional personnel in correctional agencies. A chapter on rationale discusses training objectives and curriculum. A second chapter covers learning environment, lesson plans, and learning problems. One, on teaching techniques, covers lecture, group discussion, case study,…

The Cohort for Childhood Origin of Asthma and allergic diseases (COCOA) study: design, rationale and methods

PubMed Central

2014-01-01

Background This paper describes the background, aim, and design of a prospective birth-cohort study in Korea called the COhort for Childhood Origin of Asthma and allergic diseases (COCOA). COCOA objectives are to investigate the individual and interactive effects of genetics, perinatal environment, maternal lifestyle, and psychosocial stress of mother and child on pediatric susceptibility to allergic diseases. Methods/Design The participants in COCOA represents a Korean inner-city population. Recruitment started on 19 November, 2007 and will continue until 31 December, 2015. Recruitment is performed at five medical centers and eight public-health centers for antenatal care located in Seoul. Participating mother-baby pairs are followed from before birth to adolescents. COCOA investigates whether the following five environmental variables contribute causally to the development and natural course of allergic diseases: (1) perinatal indoor factors (i.e. house-dust mite, bacterial endotoxin, tobacco smoking, and particulate matters 2.5 and 10), (2) perinatal outdoor pollutants, (3) maternal prenatal psychosocial stress and the child’s neurodevelopment, (4) perinatal nutrition, and (5) perinatal microbiome. Cord blood and blood samples from the child are used to assess whether the child’s genes and epigenetic changes influence allergic-disease susceptibility. Thus, COCOA aims to investigate the contributions of genetics, epigenetics, and various environmental factors in early life to allergic-disease susceptibility in later life. How these variables interact to shape allergic-disease susceptibility is also a key aim. The COCOA data collection schedule includes 11 routine standardized follow-up assessments of all children at 6 months and every year until 10 years of age, regardless of allergic-disease development. The mothers will complete multiple questionnaires to assess the baseline characteristics, the child’s exposure to environmental factors, maternal pre

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.

Cultural Variables Underlying Obesity in Latino Men: Design, Rationale and Participant Characteristics from the Latino Men's Health Initiative.

PubMed

Sanchez-Johnsen, Lisa; Craven, Meredith; Nava, Magdalena; Alonso, Angelica; Dykema-Engblade, Amanda; Rademaker, Alfred; Xie, Hui

2017-08-01

Overweight and obesity are associated with significant health problems and rates of obesity are high among Latino men. This paper describes the design, rationale and participant characteristics of the key demographic variables assessed in an NIH-funded study (R21-CA143636) addressing culture and several obesity-related variables (diet, physical activity, and body image) among Mexican and Puerto Rican men using a community-based participatory research framework. Participants completed objective measures (height, weight, body fat, hip, waist), a health and culture interview, a diet questionnaire, and used an accelerometer to measure their level of physical activity. A total of 203 participants completed the measures and the health and culture interview and 193 completed all study components. Puerto Ricans were older than Mexicans (p < .0001) and there were significant differences in marital status (p < .05), country of birth (p < .05), smoking (p < .05) and work status (p < .001). There were no significant differences in religion, education, health insurance, Body Mass Index, body fat, hip and waist measurements, and the language preference of the interview. Results have implications for the development of a future intervention that incorporates the role of cultural factors into a community participatory obesity intervention for Latino men.

Forum: The Rise of International Large-Scale Assessments and Rationales for Participation

ERIC Educational Resources Information Center

Addey, Camilla; Sellar, Sam; Steiner-Khamsi, Gita; Lingard, Bob; Verger, Antoni

2017-01-01

This Forum discusses the significant growth of international large-scale assessments (ILSAs) since the mid-1990s. Addey and Sellar's contribution ("A Framework for Analysing the Multiple Rationales for Participating in International Large-Scale Assessments") outlines a framework of rationales for participating in ILSAs and examines the…

Telemetry: Summary of concept and rationale

NASA Astrophysics Data System (ADS)

1987-12-01

This report presents the concept and supporting rationale for the telemetry system developed by the Consultative Committee for Space Data Systems (CCSDS). The concepts, protocols and data formats developed for the telemetry system are designed for flight and ground data systems supporting conventional, contemporary free-flyer spacecraft. Data formats are designed with efficiency as a primary consideration, i.e., format overhead is minimized. The results reflect the consensus of experts from many space agencies. An overview of the CCSDS telemetry system introduces the notion of architectural layering to achieve transparent and reliable delivery of scientific and engineering sensor data (generated aboard space vehicles) to users located in space or on earth. The system is broken down into two major conceptual categories: a packet telemetry concept and a telemetry channel coding concept. Packet telemetry facilitates data transmission from source to user in a standardized and highly automated manner. It provides a mechanism for implementing common data structures and protocols which can enhance the development and operation of space mission systems. Telemetry channel coding is a method by which data can be sent from a source to a destination by processing it in such a way that distinct messages are created which are easily distinguishable from one another. This allows construction of the data with low error probability, thus improving performance of the channel.

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

PubMed Central

2011-01-01

Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. Trial

Rationale and design of a pilot study examining Acceptance and Commitment Therapy for persistent pain in an integrated primary care clinic.

PubMed

Kanzler, Kathryn E; Robinson, Patricia J; McGeary, Donald D; Mintz, Jim; Potter, Jennifer Sharpe; Muñante, Mariana; Lopez, Eliot J; Dougherty, Donald M; Hale, Willie J; Velligan, Dawn I

2018-03-01

Most of the 100 million Americans with persistent pain are treated in primary care clinics, but evidence-based psychosocial approaches targeting pain-related disability are not usually provided in these settings. This manuscript describes the rationale and methods for a protocol to pilot test the feasibility and effectiveness of Acceptance and Commitment Therapy (ACT), an evidence-based psychological treatment for persistent pain, delivered by a Behavioral Health Consultant in primary care. Eligible patients are identified through electronic health record registries and invited to participate via secure messaging, letters and a follow-up phone call. Participants are also recruited with advertising and clinician referral. Patients agreeing to participate are consented and complete initial assessments, with a target of 60 participants. Randomization is stratified based on pain severity with participants assigned to either ACT or Enhanced Treatment as Usual (E-TAU). ACT participants receive one standardized Behavioral Health Consultation visit followed by three ACT-based group visits and one group booster visit. All patients attend six assessment visits, during which the E-TAU patients are provided with educational pain management handouts based on standard cognitive behavioral treatment of pain. The study aims to determine feasibility and effectiveness of brief ACT for persistent pain delivered by an integrated behavioral health clinician in primary care from pre- to post-treatment, and to examine mechanisms of change in ACT participants. This study, in a "real-world" setting, will lay groundwork for a larger trial. If effective, it could improve treatment methods and quality of life for patients with persistent pain using a scalable approach. Copyright © 2018 Elsevier Inc. All rights reserved.

Recruitment and Retention of Latino Children in a Lifestyle Intervention

ERIC Educational Resources Information Center

Guzman, Angelica; Richardson, Irma M.; Gesell, Sabina; Barkin, Shari L.

2009-01-01

Objective: To describe promising recruitment and retention strategies for transient Latino populations, assisting investigators who work with this population in their research design and implementation. Methods: Strategies in recruitment and retention from a year-long intervention in children and their families are described. Results: Of the 159…

Recruitment of Dual-Career Academic Medicine Couples.

PubMed

Putnam, Charles W; DiMarco, Judy; Cairns, Charles B

2017-11-28

Today it is not uncommon to discover that a candidate for a faculty position has a partner or spouse who is also an academician, adding complexity to the recruitment process. Here, the authors address two practical obstacles to the recruitment of faculty who have an academic partner: dual recruitment and conflict-of-interest. The authors have found that tandem recruitment works best when suitable positions for both spouses are first identified so that recruitment can proceed synchronously. This approach decreases misperceptions of favoritism toward either's candidacy. Managing conflict-of-interest, generated by the appointment of one spouse in a supervisory position over the other, requires a proactive, transparent, well-designed plan. After canvassing human resource policies and conducting interviews with national academic leaders, the authors have developed an administrative structure that places "key" decisions (hiring and retention; promotion and tenure; salary, bonuses, and benefits; performance evaluations; and disciplinary matters) regarding the supervised spouse in the jurisdiction of an alternate administrator or committee. The authors also offer suggestions both for mitigating misperceptions of bias in day-to-day decisions and for the support and mentoring of the supervised partner or spouse.

Evaluation of different recruitment and randomisation methods in a trial of general practitioner-led interventions to increase physical activity: a randomised controlled feasibility study with factorial design

PubMed Central

2014-01-01

Background Interventions promoting physical activity by General Practitioners (GPs) lack a strong evidence base. Recruiting participants to trials in primary care is challenging. We investigated the feasibility of (i) delivering three interventions to promote physical activity in inactive participants and (ii) different methods of participant recruitment and randomised allocation. Methods We recruited general practices from Devon, Bristol and Coventry. We used a 2-by-2 factorial design for participant recruitment and randomisation. Recruitment strategies were either opportunistic (approaching patients attending their GP surgery) or systematic (selecting patients from practice lists and approaching them by letter). Randomisation strategies were either individual or by practice cluster. Feasibility outcomes included time taken to recruit the target number of participants within each practice. Participants were randomly allocated to one of three interventions: (i) written advice (control); (ii) brief GP advice (written advice plus GP advice on physical activity), and (iii) brief GP advice plus a pedometer to self-monitor physical activity during the trial. Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity, and were instructed not to unseal the pedometer before the scheduled day of data collection. Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period, and European Quality of Life (EuroQoL)-5 dimensions (EQ-5D) scores, recorded at 12 weeks’ follow-up. Results We recruited 24 practices (12 using each recruitment method; 18 randomising by cluster, 6 randomising by individual participant), encompassing 131 participants. Opportunistic recruitment was associated with less time to target recruitment compared with systematic (mean difference (days) -54.9, 95% confidence interval (CI) -103.6; -6.2) but with greater loss to follow up

Desktop software to identify patients eligible for recruitment into a clinical trial: using SARMA to recruit to the ROAD feasibility trial.

PubMed

Treweek, Shaun; Pearson, Ewan; Smith, Natalie; Neville, Ron; Sargeant, Paul; Boswell, Brian; Sullivan, Frank

2010-01-01

Recruitment to trials in primary care is often difficult, particularly when practice staff need to identify study participants with acute conditions during consultations. The Scottish Acute Recruitment Management Application (SARMA) system is linked to general practice electronic medical record (EMR) systems and is designed to provide recruitment support to multi-centre trials by screening patients against trial inclusion criteria and alerting practice staff if the patient appears eligible. For patients willing to learn more about the trial, the software allows practice staff to send the patient's contact details to the research team by text message. To evaluate the ability of the software to support trial recruitment. Software evaluation embedded in a randomised controlled trial. Five general practices in Tayside and Fife, Scotland. SARMA was used to support recruitment to a feasibility trial (the Response to Oral Agents in Diabetes, or ROAD trial) looking at users of oral therapy in diabetes. The technical performance of the software and its utility as a recruitment tool were evaluated. The software was successfully installed at four of the five general practices and recruited 11 of the 29 participants for ROAD (other methods were letter and direct invitation by a practice nurse) and had a recruitment return of 35% (11 of 31 texts sent led to a recruitment). Screen failures were relatively low (7 of 31 referred). Practice staff members were positive about the system. An automated recruitment tool can support primary care trials in Scotland and has the potential to support recruitment in other jurisdictions. It offers a low-cost supplement to other trial recruitment methods and is likely to have a much lower screen failure rate than blanket approaches such as mailshots and newspaper campaigns.

Design and recruitment of the Chicago Healthy Living Study: a study of health behaviors in a diverse cohort of adult childhood cancer survivors.

PubMed

Stolley, Melinda R; Sharp, Lisa K; Arroyo, Claudia; Ruffin, Cherese; Restrepo, Jacqueline; Campbell, Richard

2009-09-15

Adult childhood cancer survivors are at higher risk for developing late medical effects related to their cancer treatments. Health-promoting behaviors may reduce the risk of some late effects and the severity of others. This article describes the design and recruitment of the Chicago Healthy Living Study (CHLS), an on-going study designed to examine the health behaviors and body mass index of minority adult childhood cancer survivors compared with nonminority survivors and noncancer controls. Survivors are identified by the hospital cancer registries at 5 treating institutions in the Chicago area; then, a multilevel recruitment plan will be implemented with the objective of enrolling 450 adult survivors of childhood cancer (150 in each racial/ethnic group). Simultaneously, 375 adult African-American, Hispanic, and non-Hispanic white noncancer controls (125 in each racial/ethnic group) living in the Chicago area will be recruited by using listed, targeted digit dialing. All participants will complete a 2-hour interview of questionnaires related to diet, physical activity, smoking, and associated mediators. Height and weight also will be measured. The CHLS will provide important information on the health behaviors of adult minority childhood cancer survivors that can be used to inform the development of interventions to improve modifiable risks. Copyright (c) 2009 American Cancer Society.

Bio-inspired online variable recruitment control of fluidic artificial muscles

NASA Astrophysics Data System (ADS)

Jenkins, Tyler E.; Chapman, Edward M.; Bryant, Matthew

2016-12-01

This paper details the creation of a hybrid variable recruitment control scheme for fluidic artificial muscle (FAM) actuators with an emphasis on maximizing system efficiency and switching control performance. Variable recruitment is the process of altering a system’s active number of actuators, allowing operation in distinct force regimes. Previously, FAM variable recruitment was only quantified with offline, manual valve switching; this study addresses the creation and characterization of novel, on-line FAM switching control algorithms. The bio-inspired algorithms are implemented in conjunction with a PID and model-based controller, and applied to a simulated plant model. Variable recruitment transition effects and chatter rejection are explored via a sensitivity analysis, allowing a system designer to weigh tradeoffs in actuator modeling, algorithm choice, and necessary hardware. Variable recruitment is further developed through simulation of a robotic arm tracking a variety of spline position inputs, requiring several levels of actuator recruitment. Switching controller performance is quantified and compared with baseline systems lacking variable recruitment. The work extends current variable recruitment knowledge by creating novel online variable recruitment control schemes, and exploring how online actuator recruitment affects system efficiency and control performance. Key topics associated with implementing a variable recruitment scheme, including the effects of modeling inaccuracies, hardware considerations, and switching transition concerns are also addressed.

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

PubMed

Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

2015-10-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol

PubMed Central

Koth, Laura L.; Maier, Lisa A.; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K.; Collman, Ronald G.; Hamzeh, Nabeel; Sweiss, Nadera J.; Zhang, Yingze; O’Neal, Scott; Senior, Robert M.; Becich, Michael; Hochheiser, Harry S.; Kaminski, Naftali; Wisniewski, Stephen R.; Gibson, Kevin F.

2015-01-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant’s clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis. PMID:26193069

Generational Recruiting: Applying Generational Theory to Tactical Level Recruiting

DTIC Science & Technology

2013-04-24

Development Command Quantico, Virginia 22134-5068 MASTER OF MILITARY STUDIES TITLE: GENERATIONAL RECRUITING: APPLYING GENERATIONAL THEORY TO TACTICAL...MAIN SECTION 1:The Three Generations: Their Development , Traits, Values, and How Best to Communicate With Them...evaluation of the present young adult generation of Americans to determine how to most effectively recruit and efficiently recruit this generation for

The Land Use Model Intercomparison Project (LUMIP) Contribution to CMIP6: Rationale and Experimental Design

NASA Astrophysics Data System (ADS)

Lawrence, D. M.; Hurtt, G. C.; Arneth, A.; Brovkin, V.; Calvin, K. V.; Jones, A. D.; Jones, C.; Lawrence, P.; De Noblet-Ducoudré, N.; Pongratz, J.; Seneviratne, S. I.; Shevliakova, E.

2016-12-01

Human land-use activities have resulted in large changes to the Earth surface, with resulting implications for climate. The Land Use Model Intercomparison Project (LUMIP) aims to further advance understanding of the impacts of land-use and land-cover change (LULCC) on climate, specifically addressing the questions: (1) What are the effects of LULCC on climate and biogeochemical cycling (past-future)? (2) What are the impacts of land management on surface fluxes of carbon, water, and energy and (3) Are there regional land-management strategies with promise to help mitigate against climate change? LUMIP will also address a range of more detailed science questions to get at process-level attribution, uncertainty, data requirements, and other related issues in more depth and sophistication than possible in a multi-model context to date. Foci will include separation and quantification of the effects on climate from LULCC relative to all forcings, separation of biogeochemical from biogeophysical effects of land-use, the unique impacts of land-cover change versus land management change, modulation of land-use impact on climate by land-atmosphere coupling strength, and the extent that CO2 fertilization is modulated by past and future land use. LUMIP involves three sets of activities: (1) development of an updated and expanded historical and future land-use dataset, (2) an experimental protocol for LUMIP experiments, and (3) definition of metrics that quantify model performance with respect to LULCC. LUMIP experiments are designed to be complementary to simulations requested in the CMIP6 DECK and historical simulations and other CMIP6 MIPs including ScenarioMIP, C4MIP, LS3MIP, and DAMIP. LUMIP includes idealized coupled and land-only model simulations designed to advance process-level understanding of LULCC impacts on climate. LUMIP also includes simulations that allow quantification of the historic impact of land use and the potential for future land management decisions

Effective recruitment strategies and community-based participatory research: Community Networks Program Centers’ recruitment in cancer prevention studies

PubMed Central

Greiner, K. Allen; Friedman, Daniela B.; Adams, Swann Arp; Gwede, Clement K.; Cupertino, Paula; Engelman, Kimberly K.; Meade, Cathy D.; Hébert, James R.

2014-01-01

Background Community-based participatory research (CBPR) approaches that involve community and academic partners in activities ranging from protocol design through dissemination of study findings can increase recruitment of medically underserved and underrepresented racial/ethnic minority populations into biomedical research. Settings/Methods Five cancer screening and prevention trials in three NCI-funded Community Networks Program Centers (CNPCs); in Florida, Kansas and South Carolina, were conducted across diverse populations. Data were collected on total time period of recruitment, ratios of participants enrolled over potential participants approached, selected CBPR strategies, capacity-building development, and systematic procedures for community stakeholder involvement. Findings Community-engaged approaches employed included establishing co-learning opportunities, participatory procedures for community-academic involvement, and community and clinical capacity building. A relatively large proportion of individuals identified for recruitment were actually approached (between 50% and 100%). The proportion of subjects who were eligible among all those approached ranged from 25% to over 70% (in the community setting). Recruitment rates were very high (78%–100% of eligible individuals approached) and the proportion who refused or who were not interested among those approached was very low (5%–11%). Conclusions Recruitment strategies used by the CNPCs were associated with low refusal and high enrollment ratios of potential subjects. Adherence to CBPR principles in the spectrum of research activities; from strategic planning to project implementation has significant potential to increase involvement in biomedical research and improve our ability to make appropriate recommendations for cancer prevention and control programming in underrepresented diverse populations. Impact CBPR strategies should be more widely implemented to enhance study recruitment. PMID

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol.

PubMed

Fine, Naomi B; Achituv, Michal; Etkin, Amit; Merin, Ofer; Shalev, Arieh Y

2018-01-01

Background : The immediate aftermath of traumatic events is a period of enhanced neural plasticity, following which some survivors remain with post-traumatic stress disorder (PTSD) whereas others recover. Evidence points to impairments in emotional reactivity, emotion regulation, and broader executive functions as critically contributing to PTSD. Emerging evidence further suggests that the neural mechanisms underlying these functions remain plastic in adulthood and that targeted retraining of these systems may enhance their efficiency and could reduce the likelihood of developing PTSD. Administering targeted neurocognitive training shortly after trauma exposure is a daunting challenge. This work describes a study design addressing that challenge. The study evaluated the direct effects of cognitive remediation training on neurocognitive mechanisms that hypothetically underlay PTSD, and the indirect effect of this intervention on emerging PTSD symptoms. Method : We describe a study rationale, design, and methodological choices involving: (a) participants' enrolment; (b) implementation and management of a daily self-administered, web-based intervention; (c) reliable, timely screening and assessment of treatment of eligible survivors; and (d) defining control conditions and outcome measures. We outline the rationale of choices made regarding study sample, timing of intervention, measurements, monitoring participants' adherence, and ways to harmonize and retain interviewers' fidelity and mitigate eventual burnout by repeated contacts with recently traumatized survivors. Conclusion : Early web-based interventions targeting causative mechanisms of PTSD can be informed by the model presented in this paper.

The rationale and design of the national familial hypercholesterolemia registries in Turkey: A-HIT1 and A-HIT2 studies.

PubMed

Kayıkçıoğlu, Meral; Tokgözoğlu, Lale

2017-04-01

Familial hypercholesterolemia (FH) is a genetic disease characterized by extremely high levels of cholesterol, leading to premature atherosclerosis. Although many countries have already addressed the burden of FH by means of national registries, Turkey has no national FH registry or national screening program to detect FH. Creation of a series of FH registries is planned as part of Turkish FH Initiative endorsed by the Turkish Society of Cardiology to meet this need. This article provides detailed information on the rationale and design of the first 2 FH registries (A-HIT1 and A-HIT2). A-HIT1 is a nationwide survey of adult homozygous FH (HoFH) patients undergoing low-density lipoprotein (LDL) apheresis (LA) in Turkey. A-HIT1 will provide insight into the clinical status of HoFH patients undergoing LA. Primary objective of this cross-sectional study is to identify how HoFH patients on LA are managed. Inclusion criteria are age >12 years, diagnosis of HoFH, and regular LA treatment. All available apheresis centers were electronically invited to participate in the study. The principal physicians of each center will respond to a questionnaire regarding their attitude toward LA. For each patient, another questionnaire will be used to collect data on clinical status, medication use, and disease data. In addition, patients will be asked to complete self-report questionnaires that provide information on quality of life, disease-related anxiety, and depression. A-HIT2 is a registry of adult FH patients presenting at outpatient clinics. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 statistical regions in Turkey based on the EU NUTS classification. Sites specializing in cardiology, internal medicine, and endocrinology were invited to participate. The primary objective of this cross-sectional study is to determine clinical status and management of patients in Turkey diagnosed with FH. Eligibility for screening was defined as having

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol.

PubMed

Petersen, Laura A; Urech, Tracy; Simpson, Kate; Pietz, Kenneth; Hysong, Sylvia J; Profit, Jochen; Conrad, Douglas; Dudley, R Adams; Lutschg, Meghan Z; Petzel, Robert; Woodard, Lechauncy D

2011-10-03

Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. http://www.clinicaltrials.govNCT00302718.

The Family Spirit trial for American Indian teen mothers and their children: CBPR rationale, design, methods and baseline characteristics.

PubMed

Mullany, Britta; Barlow, Allison; Neault, Nicole; Billy, Trudy; Jones, Tanya; Tortice, Iralene; Lorenzo, Sherilynn; Powers, Julia; Lake, Kristin; Reid, Raymond; Walkup, John

2012-10-01

The purpose of this paper is to describe the rationale, design, methods and baseline results of the Family Spirit trial. The goal of the trial is to evaluate the impact of the paraprofessional-delivered "Family Spirit" home-visiting intervention to reduce health and behavioral risks for American Indian teen mothers and their children. A community based participatory research (CBPR) process shaped the design of the current randomized controlled trial of the Family Spirit intervention. Between 2006 and 2008, 322 pregnant teens were randomized to receive the Family Spirit intervention plus Optimized Standard Care, or Optimized Standard Care alone. The Family Spirit intervention is a 43-session home-visiting curriculum administered by American Indian paraprofessionals to teen mothers from 28 weeks gestation until the baby's third birthday. A mixed methods assessment administered at nine intervals measures intervention impact on parental competence, mother's and children's social, emotional and behavioral risks for drug use, and maladaptive functioning. Participants are young (mean age = 18.1 years), predominantly primiparous, unmarried, and challenged by poverty, residential instability and low educational attainment. Lifetime and pregnancy drug use were ~2-4 times higher and ~5-6 times higher, respectively, than US All Races. Baseline characteristics were evenly distributed between groups, except for higher lifetime cigarette use and depressive symptoms among intervention mothers. If study aims are achieved, the public health field will have new evidence supporting multi-generational prevention of behavioral health disparities affecting young American Indian families and the utility of indigenous paraprofessional interventionists in under-resourced communities.

Design for Effective Staff Development.

ERIC Educational Resources Information Center

Seagren, Alan T.

This paper presents a model for designing an effective staff development program. The rationale, philosophy, and instructional design utilized in the instructional Staff Development (ISD) program provides the basis for the design presented. The ISD program was conceptualized, developed, pilot tested, and field tested as a cooperative research…

Quality and cost improvement of healthcare via complementary measurement and diagnosis of patient general health outcome using electronic health record data: research rationale and design.

PubMed

Stusser, Rodolfo J; Dickey, Richard A

2013-12-01

In this evolving 'third era of health', one of the US Health Care Reform Act's goals is to effectively facilitate the primary care physician's ability to better diagnose and manage the health outcome of the outpatient. That goal must include research on the complementary quantitative-qualitative assessment and rating of the patient's health status. This paper proposes an overview of the rationale and design of a research program for a balanced measurement and diagnostic clinical decision support system (CDSS) of the changing general health status of the patient -including disease- using electronic health record (EHR) data. The rationale, objectives, health metric-diagnostic tools architecture, simulation-optimization, and clinical trials are outlined. Resources, time frames, costs, feasibility, healthcare benefits and data-integration of the project are delineated. The basis and components of the research program to achieve an automated-CDSS to complement physician's clinical judgment, calculating a mathematical 'health equation' from each patient's EHR database, assisting physician-patient collaboration to diagnose, and improve general health outcomes is described. Use of multiple dimensional index, ways of classification, and causal factors' assessments, to arrive at the EHR-based CDSS algorithm-software providing a general health level and state rating of the patient are proposed. Its application could provide a compass for the general practitioner's best choice and use of the myriad of healthcare educational and technological options available with lower costs for everyday clinical practice and research. It could advance the approaches and focus of the 'eras of diseases', to the promising 'era of health', in an integrated, general approach to 'health.'

Not just another multi-professional course! Part 1. Rationale for a transformative curriculum.

PubMed

Duncan, Madeleine; Alperstein, Melanie; Mayers, Pat; Olckers, Lorna; Gibbs, Trevor

2006-02-01

Undergraduate inter- and multi-professional education has traditionally aimed to develop health professionals who are able to collaborate effectively in comprehensive healthcare delivery. The respective professions learn from and about each other through comparisons of roles, responsibilities, powers, duties and perspectives in order to promote integrated service. Described here is the educational rationale of a multi-professional course with a difference; one that injects value to undergraduate health professional education through the development of critical cross-field knowledge, skills and attitudes that unite rather than differentiate professions. The aim of this course, offered at the Faculty of Health Sciences, University of Cape Town, is to lay an integrated, pan-professional foundation for the advancement of collective commitment to and understanding of national health and social development objectives such as primary health care, human rights and professionalism. Pan-professional refers to curriculum content that is core and of critical relevance to all participating professions. What is learned, how it is learned, how learning is facilitated and how it is applied, has been co-constructed by a multi-professional design team representing a range of health professions (audiology, medicine, occupational therapy, nursing, physiotherapy and speech therapy) and academic disciplines (anthropology, sociology, psychology, history, African studies and social development, information technology and language literacy). Education specialists facilitate the ongoing design process ensuring that the structure and content of the curriculum complies with contemporary adult learning principles and national higher education imperatives. Designing the original curriculum required the deconstruction of intra-professional and disciplinary canons of knowledge and ways of 'doing things' in order to identify and develop shared interpretations of critical epistemology and axiology

A Rationale for Building a Comprehensive Science Program for Inner-City Education.

ERIC Educational Resources Information Center

Martin, Charles Arthur

The intent of this dissertation was to develop a science curriculum from an inner-city perspective. Five units and a rationale for inner-city education are included. The units include both physical and biological science topics. The units are as follows: (1) Rationale for Building a Comprehensive Science Program for Inner-City Education; (2) With…

SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity

PubMed Central

Eisenmann, Joey C; Gentile, Douglas A; Welk, Gregory J; Callahan, Randi; Strickland, Sarah; Walsh, Monica; Walsh, David A

2008-01-01

Background Although several previous projects have attempted to address the issue of child obesity through school-based interventions, the overall effectiveness of school-based programs on health-related outcomes in youth has been poor. Thus, it has been suggested that multi-level interventions that aim to influence healthy lifestyle behaviors at the community, school and family levels may prove more successful in the prevention of childhood obesity. Methods/Design This paper describes the rationale, design, and implementation of a community-, school-, and family-based intervention aimed at modifying key behaviors (physical activity, screen time (Internet, television, video games), and nutrition) related to childhood obesity among third through fifth graders in two mid-western cities. The intervention involves a randomized study of 10 schools (5 intervention and 5 control schools). The intervention is being conducted during the duration of the academic year – approximately 9 months – and includes baseline and post-intervention measurements of physical activity, dietary intake, screen time and body composition. Discussion We hope this report will be useful to researchers, public health professionals, and school administrators and health professionals (nurses and physical/health educators) seeking to develop similar prevention programs. It is obvious that more collaborative, inter-disciplinary, multi-level work is needed before a proven, effective intervention package to modify behaviors related to childhood obesity can be generally recommended. It is our hope that SWITCH is a step in that direction. Trial Registration ClinicalTrials.gov NCT00685555 PMID:18588706

Implicit Assumptions in High Potentials Recruitment

ERIC Educational Resources Information Center

Posthumus, Jan; Bozer, Gil; Santora, Joseph C.

2016-01-01

Purpose: Professionals of human resources (HR) use different criteria in practice than they verbalize. Thus, the aim of this research was to identify the implicit criteria used for the selection of high-potential employees in recruitment and development settings in the pharmaceutical industry. Design/methodology/approach: A semi-structured…

Providence Sponsors Diocesan Teacher Recruiting Campaign.

ERIC Educational Resources Information Center

Dygert, William

2001-01-01

Addresses the issue of teacher recruitment in Providence, Rhode Island. Explains that the Catholic education staff designed a campaign that involved creating marketing materials, advertising in daily newspapers, and holding job fairs and open houses. Stresses the importance of promoting teaching at Catholic schools as both rewarding and…

Tracing the Rationale Behind UML Model Change Through Argumentation

NASA Astrophysics Data System (ADS)

Jureta, Ivan J.; Faulkner, Stéphane

Neglecting traceability—i.e., the ability to describe and follow the life of a requirement—is known to entail misunderstanding and miscommunication, leading to the engineering of poor quality systems. Following the simple principles that (a) changes to UML model instances ought be justified to the stakeholders, (b) justification should proceed in a structured manner to ensure rigor in discussions, critique, and revisions of model instances, and (c) the concept of argument instantiated in a justification process ought to be well defined and understood, the present paper introduces the UML Traceability through Argumentation Method (UML-TAM) to enable the traceability of design rationale in UML while allowing the appropriateness of model changes to be checked by analysis of the structure of the arguments provided to justify such changes.

Cost-effectiveness of health research study participant recruitment strategies: a systematic review.

PubMed

Huynh, Lynn; Johns, Benjamin; Liu, Su-Hsun; Vedula, S Swaroop; Li, Tianjing; Puhan, Milo A

2014-10-01

A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials. To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies. We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies. We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$-International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials. We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis. Systematic and explicit reporting of

How might acupuncture work? A systematic review of physiologic rationales from clinical trials.

PubMed

Moffet, Howard H

2006-07-07

Scientific interest in acupuncture has led numerous investigators to conduct clinical trials to test the efficacy of acupuncture for various conditions, but the mechanisms underlying acupuncture are poorly understood. The author conducted a PubMed search to obtain a fair sample of acupuncture clinical trials published in English in 2005. Each article was reviewed for a physiologic rationale, as well as study objectives and outcomes, experimental and control interventions, country of origin, funding sources and journal type. Seventy-nine acupuncture clinical trials were identified. Twenty-six studies (33%) offered no physiologic rationale. Fifty-three studies (67%) posited a physiologic basis for acupuncture: 33 (62% of 53) proposed neurochemical mechanisms, 2 (4%) segmental nervous system effects, 6 (11%) autonomic nervous system regulation, 3 (6%) local effects, 5 (9%) effects on brain function and 5 (9%) other effects. No rationale was proposed for stroke; otherwise having a rationale was not associated with objective, positive or negative findings, means of intervention, country of origin, funding source or journal type. The dominant explanation for how acupuncture might work involves neurochemical responses and is not reported to be dependent on treatment objective, specific points, means or method of stimulation. Many acupuncture trials fail to offer a meaningful rationale, but proposing a rationale can help investigators to develop and test a causal hypothesis, choose an appropriate control and rule out placebo effects. Acupuncture may stimulate self-regulatory processes independent of the treatment objective, points, means or methods used; this would account for acupuncture's reported benefits in so many disparate pathologic conditions.

Dose timing of D-cycloserine to augment cognitive behavioral therapy for social anxiety: Study design and rationale.

PubMed

Hofmann, Stefan G; Carpenter, Joseph K; Otto, Michael W; Rosenfield, David; Smits, Jasper A J; Pollack, Mark H

2015-07-01

The use of D-cycloserine (DCS) as a cognitive enhancer to augment exposure-based cognitive-behavioral therapy (CBT) represents a promising new translational research direction with the goal to accelerate and optimize treatment response for anxiety disorders. Some studies suggest that DCS may not only augment extinction learning but could also facilitate fear memory reconsolidation. Therefore, the effect of DCS may depend on fear levels reported at the end of exposure sessions. This paper presents the rationale and design for a randomized controlled trial examining the relative efficacy of tailoring DCS administration based on exposure success (i.e. end fear levels) during a 5-session group CBT protocol for social anxiety disorder (n = 156). Specifically, tailored post-session DCS administration will be compared against untailored post-session DCS, untailored pre-session DCS, and pill placebo in terms of reduction in social anxiety symptoms and responder status. In addition, a subset of participants (n = 96) will undergo a fear extinction retention experiment prior to the clinical trial in which they will be randomly assigned to receive either DCS or placebo prior to extinguishing a conditioned fear. The results from this experimental paradigm will clarify the mechanism of the effects of DCS on exposure procedures. This study aims to serve as the first step toward developing an algorithm for the personalized use of DCS during CBT for social anxiety disorder, with the ultimate goal of optimizing treatment outcome for anxiety disorders. Copyright © 2015 Elsevier Inc. All rights reserved.

Using re-randomization to increase the recruitment rate in clinical trials - an assessment of three clinical areas.

PubMed

Kahan, Brennan C

2016-12-13

Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be increased in practice. We modelled the expected recruitment rate for parallel-group and re-randomization trials in different settings based on estimates from real trials and datasets. We considered three clinical areas: in vitro fertilization, severe asthma exacerbations, and acute sickle cell pain crises. We compared the two designs in terms of the expected time to complete recruitment, and the sample size recruited over a fixed recruitment period. Across the different scenarios we considered, we estimated that re-randomization could reduce the expected time to complete recruitment by between 4 and 22 months (relative reductions of 19% and 45%), or increase the sample size recruited over a fixed recruitment period by between 29% and 171%. Re-randomization can increase recruitment most for trials with a short follow-up period, a long trial recruitment duration, and patients with high rates of treatment episodes. Re-randomization has the potential to increase the recruitment rate in certain settings, and could lead to quicker and more efficient trials in these scenarios.

Supplement use in sport: is there a potentially dangerous incongruence between rationale and practice?

PubMed Central

Petróczi, Andrea; Naughton, Declan P

2007-01-01

Background Supplement use by athletes is complex and research supports the alarming notion of misinformed decisions regarding supplements. Hypothesis A frequent divergence between the type of supplements chosen by athletes and the rationale dictating the supplement use is hypothesized. Thus, a potentially dangerous incongruence may exist between rationale and practice. Testing the hypothesis In the continued absence of reliable data on supplement use, an alternative approach of studying the reasons underlying supplement use in athletes is proposed to determine whether there is an incongruence between rationale and practice. Existing data from large scale national surveys can be used to investigate this incongruence. Implications of the hypothesis In this report, analyses of distinctive patterns between the use and rationale for use of supplements among athletes are recommended to explore this potentially dangerous phenomenon. PMID:17535442

Examination of print and telephone channels for physical activity promotion: Rationale, design, and baseline data from Project STRIDE.

PubMed

Marcus, Bess H; Napolitano, Melissa A; King, Abby C; Lewis, Beth A; Whiteley, Jessica A; Albrecht, Anna E; Parisi, Alfred F; Bock, Beth C; Pinto, Bernardine M; Sciamanna, Christopher A; Jakicic, John M; Papandonatos, George D

2007-01-01

Project STRIDE is a 4-year randomized controlled trial comparing two computer-based expert system guided intervention delivery channels (phone vs. print) for physical activity adoption and short-term maintenance among previously sedentary adults. Sedentary adults (n=239) were randomized to one of the following (1) telephone-based, individualized motivationally-tailored feedback; (2) print-based, individualized motivationally-tailored feedback; (3) contact-control delayed treatment group (received intervention after 12 months as control). This paper: (1) outlines the study design, rationale, and participant sample; and (2) describes relationships between baseline variables to better understand their influence on the efficacy of the intervention. Participants averaged 19.8+/-25.0 min of physical activity/week that was at least of moderate intensity, with no group differences. The average estimated VO(2) at 85% of maximum heart rate was 25.6 ml/kg/min. Body fat was 34.1% for women and 23.2% for men and the BMI of the sample averaged 28.5 kg/m(2). Project STRIDE examines non face-to-face approaches for promoting physical activity behavior. It has unique features including a direct comparison of an expert system guided intervention delivered via phone or print. Future analyses will examine the cost-effectiveness of the interventions and this will likely yield important information for policy-makers.

Corporate social marketing: message design to recruit program participants.

PubMed

Black, David R; Blue, Carolyn L; Coster, Daniel C; Chrysler, Lisa M

2002-01-01

To identify variables for a corporate social marketing (SM) health message based on the 4 Ps of SM in order to recruit future participants to an existing national, commercial, self-administered weight-loss program. A systematically evaluated, author-developed, 310-response survey was administered to a random sample of 270 respondents. A previously established research plan was used to empirically identify the audience segments and the "marketing mix" appropriate for the total sample and each segment. Tangible product, pertaining to the unique program features, should be emphasized rather than positive core product and outcome expectation related to use of the program.

Recruiting to a large-scale physical activity randomised controlled trial - experiences with the gift of hindsight.

PubMed

Copeland, Robert J; Horspool, Kimberley; Humphreys, Liam; Scott, Emma

2016-02-24

Recruitment issues continue to impact a large number of trials. Sharing recruitment information is vital to supporting researchers to accurately predict recruitment and to manage the risk of poor recruitment during study design and implementation. The purpose of this article is to build on the knowledge available to researchers on recruiting to community-based trials. A critical commentary of the recruitment challenges encountered during the Booster Study, a randomised controlled trial in which researchers investigated the effectiveness of a motivational interviewing style intervention on the maintenance of physical activity. An overview of recruitment is provided, as well as strategies employed to recruit prospective participants and possible barriers to recruitment. Two hundred eighty-two people, 47 % of the original target, were recruited through mail-outs, with secondary recruitment pathways yielding no additional participants. The research team encountered problems with recontacting interested participants and providing study materials in non-English languages. A lower response rate to the mail-out and a greater number of non-contactable participants in the full study than in the pilot study resulted in a smaller pool of eligible participants from the brief intervention eligible for recruitment into the randomised controlled trial. Despite using widely accepted recruitment strategies and incorporating new recruitment tactics in response to challenges, the Booster Study investigators failed to randomise a sufficient number of participants. Recruitment in trials of community-based behavioural interventions may have different challenges than trials based on clinical or primary care pathways. Specific challenges posed by the complexity of the study design and problems with staffing and resources were exacerbated by the need to revise upwards the number of mailed invitations as a result of the pilot study. Researchers should ensure study design facilitates

Guidelines for research recruitment of underserved populations (EERC).

PubMed

Matsuda, Yui; Brooks, Jada L; Beeber, Linda S

2016-11-01

Despite concerted efforts to establish health equity, significant disparities persist. One roadblock to eliminating health disparities is the inadequate recruitment of underserved populations, which prevents researchers from creating culturally-tailored interventions. To further develop the science of recruitment, we argue that a systematic approach should be applied to research participant recruitment. Given the lack of practical and comprehensive recruitment conceptual frameworks or guidelines in the literature, the authors propose newly synthesized guidelines for research recruitment of underserved populations: EERC (evaluate, engage, reflect, and carefully match). The EERC guidelines are delineated, and the application of these guidelines is illustrated through a study recently conducted by the authors. The guidelines consist of the following four components: 1. Evaluate the composition of the research team; 2. Engage fully with the community by working with key informants and cultural insiders; 3. Reflect the unique cultural characteristics of the community in the research conduct; and 4. Carefully use a matching technique. The application component of the article demonstrates concrete examples of how the guidelines can enhance research recruitment for an underserved population. The authors intend these guidelines to be broadly applicable for research teams regardless of research design or characteristics of the underserved population. Application of these guidelines in nursing and health science will contribute to increasing research recruitment of underserved populations, with the goal of reducing health disparities and achieving health equity for all persons. Copyright © 2016 Elsevier Inc. All rights reserved.

Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669)

PubMed Central

2014-01-01

Background Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. Methods/Design This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. Discussion This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. Trial registration Current Controlled Trials ISRCTN52269669. PMID:25012813

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.

The Land Use Model Intercomparison Project (LUMIP) contribution to CMIP6: rationale and experimental design

NASA Astrophysics Data System (ADS)

Lawrence, David M.; Hurtt, George C.; Arneth, Almut; Brovkin, Victor; Calvin, Kate V.; Jones, Andrew D.; Jones, Chris D.; Lawrence, Peter J.; de Noblet-Ducoudré, Nathalie; Pongratz, Julia; Seneviratne, Sonia I.; Shevliakova, Elena

2016-09-01

complementary to simulations requested in the CMIP6 DECK and historical simulations and other CMIP6 MIPs including ScenarioMIP, C4MIP, LS3MIP, and DAMIP. LUMIP includes a two-phase experimental design. Phase one features idealized coupled and land-only model simulations designed to advance process-level understanding of LULCC impacts on climate, as well as to quantify model sensitivity to potential land-cover and land-use change. Phase two experiments focus on quantification of the historic impact of land use and the potential for future land management decisions to aid in mitigation of climate change. This paper documents these simulations in detail, explains their rationale, outlines plans for analysis, and describes a new subgrid land-use tile data request for selected variables (reporting model output data separately for primary and secondary land, crops, pasture, and urban land-use types). It is essential that modeling groups participating in LUMIP adhere to the experimental design as closely as possible and clearly report how the model experiments were executed.

The Land Use Model Intercomparison Project (LUMIP) contribution to CMIP6: rationale and experimental design

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

Lawrence, David M.; Hurtt, George C.; Arneth, Almut

designed to be complementary to simulations requested in the CMIP6 DECK and historical simulations and other CMIP6 MIPs including ScenarioMIP, C4MIP, LS3MIP, and DAMIP. LUMIP includes a two-phase experimental design. Phase one features idealized coupled and land-only model simulations designed to advance process-level understanding of LULCC impacts on climate, as well as to quantify model sensitivity to potential land-cover and land-use change. Phase two experiments focus on quantification of the historic impact of land use and the potential for future land management decisions to aid in mitigation of climate change. This paper documents these simulations in detail, explains their rationale, outlines plans for analysis, and describes a new subgrid land-use tile data request for selected variables (reporting model output data separately for primary and secondary land, crops, pasture, and urban land-use types). It is essential that modeling groups participating in LUMIP adhere to the experimental design as closely as possible and clearly report how the model experiments were executed.« less

The Land Use Model Intercomparison Project (LUMIP) contribution to CMIP6: rationale and experimental design

DOE PAGES

Lawrence, David M.; Hurtt, George C.; Arneth, Almut; ...

2016-09-02

designed to be complementary to simulations requested in the CMIP6 DECK and historical simulations and other CMIP6 MIPs including ScenarioMIP, C4MIP, LS3MIP, and DAMIP. LUMIP includes a two-phase experimental design. Phase one features idealized coupled and land-only model simulations designed to advance process-level understanding of LULCC impacts on climate, as well as to quantify model sensitivity to potential land-cover and land-use change. Phase two experiments focus on quantification of the historic impact of land use and the potential for future land management decisions to aid in mitigation of climate change. This paper documents these simulations in detail, explains their rationale, outlines plans for analysis, and describes a new subgrid land-use tile data request for selected variables (reporting model output data separately for primary and secondary land, crops, pasture, and urban land-use types). It is essential that modeling groups participating in LUMIP adhere to the experimental design as closely as possible and clearly report how the model experiments were executed.« less

Effect of ticagrelor with clopidogrel on high on-treatment platelet reactivity in acute stroke or transient ischemic attack (PRINCE) trial: Rationale and design.

PubMed

Wang, Yilong; Lin, Yi; Meng, Xia; Chen, Weiqi; Chen, Guohua; Wang, Zhimin; Wu, Jialing; Wang, Dali; Li, Jianhua; Cao, Yibin; Xu, Yuming; Zhang, Guohua; Li, Xiaobo; Pan, Yuesong; Li, Hao; Liu, Liping; Zhao, Xingquan; Wang, Yongjun

2017-04-01

Rationale and aim Little is known about the safety and efficacy of the combination of ticagrelor and aspirin in acute ischemic stroke. This study aimed to evaluate whether the combination of ticagrelor and aspirin was superior to that of clopidogrel and aspirin in reducing the 90-day high on-treatment platelet reactivity for acute minor stroke or transient ischemic attack, especially for carriers of cytochrome P450 2C19 loss-of-function allele. Sample size and design This study was designed as a prospective, multicenter, randomized, open-label, active-controlled, and blind-endpoint, phase II b trial. The required sample size was 952 patients. It was registered with ClinicalTrials.gov (NCT02506140). Study outcomes The primary outcome was the proportion of patients with high on-treatment platelet reactivity at 90 days. High on-treatment platelet reactivity is defined as the P2Y12 reaction unit >208 measured using the VerifyNow P2Y12 assay. Conclusion The Platelet Reactivity in Acute Non-disabling Cerebrovascular Events study explored whether ticagrelor combined with aspirin could reduce further the proportion of patients with high on-treatment platelet reactivity at 90 days after acute minor stroke or transient ischemic attack compared with clopidogrel and aspirin.

[Rationale, design and methodology of physical attributes identification of the fear of falling syndrome (FISTAC study)].

PubMed

Esbrí Víctor, Mariano; Huedo Rodenas, Isabel; López Utiel, Melisa; Martínez Reig, Marta; López Jiménez, Esther; Herizo Muñoz, María Ángeles; Sánchez Nievas, Ginés; Abizanda Soler, Pedro

The aim of this study was to identify the physical determining factors of the Fear of Falling Syndrome (FoF) in older adults with a history of falls. An observational study was conducted on 183 subjects older than 64 years with a fall in the previous year, with data collected from the geriatrics outpatient clinic of the Complejo Hospitalario Universitario from Albacete, Spain. Sociodemographic and anthropometric data, as well as comorbidity, drugs usually taken, functional status, physical function, frailty, cognitive and affective status were collected. Muscle mass was measured using bioimpedancy meter (BIA), and densitometry (DXA), strength with digital hand-held JAMAR dynamometer and with a Leg-press machine, muscle potency with a T-Force instrument, gait variability with the Gait-Rite instrument, and postural stability with the Neurocom Balance Master posturograph were also determined. An analysis was performed to determine if the FoF is associated with physical impairments adjusted for the study covariates. The study included 140 subjects with FoF, and 43 without it. The mean age was 78.4 years, and 147 were women. Posturography could be measured in 182 participants, DXA in 117, BIA in 165, and muscle potency in 146. FoF was associated with female sex, frailty, depressed mood, social risk, muscle strength and power, physical function, number of drugs used, and orthostatic hypotension in the overall sample. After adjusting for sex, only frailty, depressed mood, and number of drugs remained associated. Rationale, design, and methods of the FISTAC study are presented. Copyright © 2016 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

PubMed

Abraham, William T; Burkhoff, Daniel; Nademanee, Koonlawee; Carson, Peter; Bourge, Robert; Ellenbogen, Kenneth A; Parides, Michael; Kadish, Alan

2008-10-01

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.

Childhood obesity prevention in rural settings: background, rationale, and study design of '4-Health,' a parent-only intervention.

PubMed

Lynch, Wesley C; Martz, Jill; Eldridge, Galen; Bailey, Sandra J; Benke, Carrie; Paul, Lynn

2012-04-02

Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent-child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program) or a "best-practices" (Healthy Living Information) control group. This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents' ability to intervene effectively in the lives of their families during this critical developmental period. ClinicalTrials.gov ID: NCT01510587.

Social Stories[TM]: A Possible Theoretical Rationale

ERIC Educational Resources Information Center

Reynhout, Georgina; Carter, Mark

2011-01-01

Social Stories[TM] are an intervention widely used with individuals with autism spectrum disorders (ASD). This paper discusses a possible theoretical rationale that might account for the purported efficacy of Social Stories[TM]. Attributes of individuals with ASD in relation to Social Story intervention including difficulties with theory of mind…

Adhesives: Test Method, Group Assignment, and Categorization Guide for High-Loading Rate Applications - History and Rationale

DTIC Science & Technology

2017-04-20

Categorization Guide for High -Loading- Rate Applications – History and Rationale by Robert Jensen, David Flanagan, Daniel DeSchepper, and Charles...Adhesives: Test Method, Group Assignment, and Categorization Guide for High -Loading- Rate Applications – History and Rationale by Robert Jensen...Categorization Guide for High - Loading-Rate Applications – History and Rationale 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6

Rationale, design, and methodology of a trial evaluating three models of care for HCV treatment among injection drug users on opioid agonist therapy.

PubMed

Akiyama, Matthew J; Agyemang, Linda; Arnsten, Julia H; Heo, Moonseong; Norton, Brianna L; Schackman, Bruce R; Linas, Benjamin P; Litwin, Alain H

2018-02-09

People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York. In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness. This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack

Implementing Attachment and Biobehavioral Catch-Up with birth parents: Rationale and case example.

PubMed

Hoye, Julie R; Dozier, Mary

2018-05-25

Attachment and Biobehavioral Catch-Up (ABC) is an intervention designed for vulnerable children and their parents. This intervention enhances parental sensitivity and nurturance with the goal of promoting secure, organized attachments and strong self-regulatory capabilities among children. Here, we provide a brief rationale for the need for such interventions to be delivered to parent-child dyads in the child welfare system. Next, we review specific intervention targets of ABC. We include a case example of two birth parents and their daughter who became involved in Child Protective Services due to domestic violence. © 2018 Wiley Periodicals, Inc.

An unusual recruitment strategy in a mass-recruiting stingless bee, Partamona orizabaensis.

PubMed

Flaig, Isabelle C; Aguilar, Ingrid; Schmitt, Thomas; Jarau, Stefan

2016-10-01

Foragers of several stingless bee species deposit attractive scent marks on solid substrates to precisely recruit nestmates to food. Interestingly, Partamona workers quickly recruit large numbers of nest mates to resources, likely even without the deposition of attractive scent marks. However, systematic studies of the recruitment system of these bees are lacking. We now studied the recruitment behavior of P. orizabaensis. Our findings show that foragers of this species can recruit large numbers of nestmates to food sources at a particular location. The precise nestmate recruitment does not rely on attractive scent marks deposited on substrates. We never observed any scent marking behavior and feeders baited with labial or mandibular gland extracts were not attractive for the bees. Chemical analyses showed that the foragers' labial gland secretions exclusively contain long chain hydrocarbons, which render their role in recruitment communication unlikely. Whether mandibular gland secretions, which contain esters and alcohols that are known as attractive pheromones in other bee species, are used to guide recruits toward food during flight, remains elusive. We conclude that Partamona's quick recruitment system that does not rely on conspicuous scent marks has evolved as a strategy against competition with sympatrically occurring and more aggressive bee species.

Placebo versus "standard" hypnosis rationale: attitudes, expectancies, hypnotic responses, and experiences.

PubMed

Accardi, Michelle; Cleere, Colleen; Lynn, Steven Jay; Kirsch, Irving

2013-10-01

In this study participants were provided with either the standard rationale that accompanies the Harvard Group Scale of Hypnotic Susceptibility: A (Shor & Orne, 1962) or a rationale that presented hypnosis as a nondeceptive placebo, consistent with Kirsch's (1994) sociocognitive perspective of hypnosis. The effects of the placebo and standard rationales were highly comparable with respect to hypnotic attitudes; prehypnotic expectancies; objective, subjective, and involuntariness measures of hypnotic responding; as well as a variety of subjective experiences during hypnosis, as measured by the Phenomenology of Consciousness Inventory (Pekala, 1982). Differences among correlations were not evident when measures were compared across groups. However, indices of hypnotic responding were correlated with attitudes in the hypnosis but not the placebo condition, and, generally speaking, the link between subjective experiences during hypnosis and measures of hypnotic responding were more reliable in the placebo than the hypnosis group. Researcher findings are neutral with respect to providing support for altered state versus sociocognitive models of hypnosis.

On decentralized design: Rationale, dynamics, and effects on decision-making

NASA Astrophysics Data System (ADS)

Chanron, Vincent

The focus of this dissertation is the design of complex systems, including engineering systems such as cars, airplanes, and satellites. Companies who design these systems are under constant pressure to design better products that meet customer expectations, and competition forces them to develop them faster. One of the responses of the industry to these conflicting challenges has been the decentralization of the design responsibilities. The current lack of understanding of the dynamics of decentralized design processes is the main motivation for this research, and places value on the descriptive base. It identifies the main reasons and the true benefits for companies to decentralize the design of their products. It also demonstrates the limitations of this approach by listing the relevant issues and problems created by the decentralization of decisions. Based on these observations, a game-theoretic approach to decentralized design is proposed to model the decisions made during the design process. The dynamics are modeled using mathematical formulations inspired from control theory. Building upon this formalism, the issue of convergence in decentralized design is analyzed: the equilibrium points of the design space are identified and convergent and divergent patterns are recognized. This rigorous investigation of the design process provides motivation and support for proposing new approaches to decentralized design problems. Two methods are developed, which aim at improving the design process in two ways: decreasing the product development time, and increasing the optimality of the final design. The frame of these methods are inspired by eigenstructure decomposition and set-based design, respectively. The value of the research detailed within this dissertation is in the proposed methods which are built upon the sound mathematical formalism developed. The contribution of this work is two fold: rigorous investigation of the design process, and practical support to

Cultures of Success: Recruiting and Retaining New Live-In Residence Life Professionals

ERIC Educational Resources Information Center

Belch, Holly A.; Wilson, Maureen E.; Dunkel, Norbert

2009-01-01

A qualitative inquiry designed to understand entry-level, live-in, professional staff recruitment and retention practices perceived as successful revealed a link to elements of organizational culture. Several important areas of understanding emerged: the actual recruitment and retention practices, the impact of leadership, and the role of…

Dose Timing of D-cycloserine to Augment Cognitive Behavioral Therapy for Social Anxiety: Study Design and Rationale

PubMed Central

Carpenter, Joseph K.; Otto, Michael W.; Rosenfield, David; Smits, Jasper A. J.; Pollack, Mark H.

2015-01-01

The use of d-cycloserine (DCS) as a cognitive enhancer to augment exposure-based cognitive-behavioral therapy (CBT) represents a promising new translational research direction with the goal to accelerate and optimize treatment response for anxiety disorders. Some studies suggest that DCS may not only augment extinction learning but could also facilitate fear memory reconsolidation. Therefore, the effect of DCS may depend on fear levels reported at the end of exposure sessions. This paper presents the rationale and design for an ongoing randomized controlled trial examining the relative efficacy of tailoring DCS administration based on exposure success (i.e. end fear levels) during a 5-session group CBT protocol for social anxiety disorder (n = 156). Specifically, tailored post-session DCS administration will be compared against untailored post-session DCS, untailored pre-session DCS, and pill placebo in terms of reduction in social anxiety symptoms and responder status. In addition, a subset of participants (n = 96) will undergo a fear extinction retention experiment prior to the clinical trial in which they will be randomly assigned to receive either DCS or placebo prior to extinguishing a conditioned fear. The results from this experimental paradigm will clarify the mechanism of the effects of DCS on exposure procedures. This study aims to serve as the first step toward developing an algorithm for the personalized use of DCS during CBT for social anxiety disorder, with the ultimate goal of optimizing treatment outcome for anxiety disorders. ClinicalTrials.gov identifier: NCT02066792 PMID:26111923

The NordICC Study: Rationale and design of a randomized trial on colonoscopy screening for colorectal cancer

PubMed Central

F.Kaminski, Michal; Bretthauer, Michael; Zauber, Ann G.; Kuipers, Ernst J.; Adami, Hans-Olov; van Ballegooijen, Marjolein; Regula, Jaroslaw; van Leerdam, Monique; Stefansson, Tryggvi; Påhlman, Lars; Dekker, Evelien; Hernán, Miguel A.; Garborg, Kjetil; Hoff, Geir

2017-01-01

Background While colonoscopy screening is widely used in several European countries and the United States, no randomised trials exist to quantify its benefits. The Nordic-European Initiative on Colorectal Cancer (NordICC) is a multinational, randomized controlled trial aiming at investigating the effect of colonoscopy screening on CRC incidence and mortality. This paper describes the rationale and design of the NordICC trial. Material and methods Men and women age 55 to 64 years are drawn from the population registries in the participating countries and randomly assigned to either once-only colonoscopy screening with removal of all detected lesions, or no screening (standard of care in the trial regions). All individuals are followed for 15 years after inclusion using dedicated national registries. Results The primary endpoints of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow up. We hypothesize a 50% CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50% compliance, yielding a 25% mortality reduction among those invited to screening. For 90% power and a two-sided alpha level of 0.05, using a 2:1 randomisation, 45,600 individuals will be randomised to control, and 22,800 individuals to the colonoscopy group. Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10 years follow-up. Conclusions The aim of the NordICC trial is to quantify the effectiveness of population-based colonoscopy screening. This will allow development of evidence-based guidelines for CRC screening in the general population. PMID:22723185

Rationale for the Use of CAD/CAM Technology in Implant Prosthodontics

PubMed Central

Abduo, Jaafar; Lyons, Karl

2013-01-01

Despite the predictable longevity of implant prosthesis, there is an ongoing interest to continue to improve implant prosthodontic treatment and outcomes. One of the developments is the application of computer-aided design and computer-aided manufacturing (CAD/CAM) to produce implant abutments and frameworks from metal or ceramic materials. The aim of this narrative review is to critically evaluate the rationale of CAD/CAM utilization for implant prosthodontics. To date, CAD/CAM allows simplified production of precise and durable implant components. The precision of fit has been proven in several laboratory experiments and has been attributed to the design of implants. Milling also facilitates component fabrication from durable and aesthetic materials. With further development, it is expected that the CAD/CAM protocol will be further simplified. Although compelling clinical evidence supporting the superiority of CAD/CAM implant restorations is still lacking, it is envisioned that CAD/CAM may become the main stream for implant component fabrication. PMID:23690778

Vestibular recruitment

NASA Technical Reports Server (NTRS)

Tsemakhov, S. G.

1980-01-01

Vestibular recruitment is defined through the analysis of several references. It is concluded that vestibular recruitment is an objective phenomenon which manifests itself during the affection of the vestibular receptor and thus serves as a diagnostic tool during affection of the vestibular system.

Adult Recruitment Practices.

ERIC Educational Resources Information Center

Kaufman, Juliet, Ed.; And Others

Findings of an American College Testing Program 1981 survey on college recruitment of adult students are summarized, and 12 articles on adult recruitment are presented. Titles and authors are as follows: "Adult Recruitment Practices: A Report of a National Survey" (Patricia Spratt, Juliet Kaufmann, Lee Noel); "Three Programs for Adults in Shopping…

Local sensitivity of per-recruit fishing mortality reference points.

PubMed

Cadigan, N G; Wang, S

2016-12-01

We study the sensitivity of fishery management per-recruit harvest rates which may be part of a quantitative harvest strategy designed to achieve some objective for catch or population size. We use a local influence sensitivity analysis to derive equations that describe how these reference harvest rates are affected by perturbations to productivity processes. These equations give a basic theoretical understanding of sensitivity that can be used to predict what the likely impacts of future changes in productivity will be. Our results indicate that per-recruit reference harvest rates are more sensitive to perturbations when the equilibrium catch or population size per recruit, as functions of the harvest rate, have less curvature near the reference point. Overall our results suggest that per recruit reference points will, with some exceptions, usually increase if (1) growth rates increase, (2) natural mortality rates increase, or (3) fishery selectivity increases to an older age.

Childhood obesity prevention in rural settings: background, rationale, and study design of ‘4-Health,’ a parent-only intervention

PubMed Central

2012-01-01

Background Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. Methods/Design A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent–child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program) or a “best-practices” (Healthy Living Information) control group. Discussion This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents’ ability to intervene effectively in the lives of their families during this critical developmental period. Trial registration ClinicalTrials.gov ID: NCT01510587 PMID:22471650

Help Design Software Project

DTIC Science & Technology

1988-11-30

discrete guidelines or rules to be used in the design. They pay little if any attention to how the developer can utilize the guidance. At best, they...designer’s attention on the critical design features and present ihe rationale for those features. It also describes alternative designs that were...more leading between lines, and careful attention to the selection of fonts (Rubens and Krull, 1985 ; Brockman, 1986). Bradford (1984) outlines the

Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening

PubMed Central

2010-01-01

Background Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus (T2DM). Latent phase identification through screening requires structured, appropriately targeted population-based approaches. Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from randomised intervention trials in screen-detected T2DM cases. UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM. To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care. Here we describe the rationale and methods of a systematic community screening programme and randomised controlled trial of cardiovascular risk management within a UK multiethnic setting (ADDITION-Leicester). Design A single-blind cluster randomised, parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care. Methods ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practices coordinated from a single academic research centre. Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40-75 years (25-75 years South Asian). Volunteers also provide detailed medical and family histories; complete health questionnaires, undergo anthropometric measures, lipid profiling and a proteinuria assessment. Primary outcome is reduction in modelled Coronary Heart Disease (UKPDS CHD) risk at five years. Seven thousand (30% of South Asian ethnic origin) volunteers over three years will be recruited to identify a screen-detected T2DM cohort (n = 285) powered to detected a 6% relative difference (80% power, alpha 0.05) between treatment

Enzyme Recruitment and Its Role in Metabolic Expansion

PubMed Central

2015-01-01

Although more than 109 years have passed since the existence of the last universal common ancestor, proteins have yet to reach the limits of divergence. As a result, metabolic complexity is ever expanding. Identifying and understanding the mechanisms that drive and limit the divergence of protein sequence space impact not only evolutionary biologists investigating molecular evolution but also synthetic biologists seeking to design useful catalysts and engineer novel metabolic pathways. Investigations over the past 50 years indicate that the recruitment of enzymes for new functions is a key event in the acquisition of new metabolic capacity. In this review, we outline the genetic mechanisms that enable recruitment and summarize the present state of knowledge regarding the functional characteristics of extant catalysts that facilitate recruitment. We also highlight recent examples of enzyme recruitment, both from the historical record provided by phylogenetics and from enzyme evolution experiments. We conclude with a look to the future, which promises fruitful consequences from the convergence of molecular evolutionary theory, laboratory-directed evolution, and synthetic biology. PMID:24483367

Recruitment of Chinese American Elders into Dementia Research: The UCSF ADRC Experience

ERIC Educational Resources Information Center

Chao, Steven Z.; Lai, Ngan B.; Tse, Marian M.; Ho, Rachel J.; Kong, Joanne P.; Matthews, Brandy R.; Miller, Bruce L.; Rosen, Howard J.

2011-01-01

Purpose: To describe the results of efforts to recruit Asian Americans into longitudinal research on cognitive decline in aging. Design and Methods: Recruitment strategies include clinics for assessment of cognitive impairment at the University of California, San Francisco campus and San Francisco's Chinatown, lectures to local health care…

What Recruiters Should Look for in Applicants.

ERIC Educational Resources Information Center

Steele, E.W.

1981-01-01

One method for determining requirements of job applicants is to survey, by function, various segments of the company. A three-part questionnaire was designed to identify the preferences of hiring supervisors, the personal attitudes of management, and feelings related to recruiting women/minorities and obsolete employees. (Author/KMF)

Teacher Grading Decisions: Influences, Rationale, and Practices

ERIC Educational Resources Information Center

Kunnath, Joshua P.

2017-01-01

This mixed-methods study applied a decision-making theoretical framework to an investigation of teacher grading in a large urban school district in California. A sample of 251 high school teachers of core subjects were surveyed, and 15 teachers participated in four focus group interviews in order provide data on the influences, rationale, and…

6 CFR 17.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 6 Domestic Security 1 2010-01-01 2010-01-01 false Recruitment. 17.310 Section 17.310 Domestic... in Admission and Recruitment Prohibited § 17.310 Recruitment. (a) Nondiscriminatory recruitment. A... recruitment and admission of students. A recipient may be required to undertake additional recruitment efforts...

14 CFR 1253.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Recruitment. 1253.310 Section 1253.310... in Admission and Recruitment Prohibited § 1253.310 Recruitment. (a) Nondiscriminatory recruitment. A... recruitment and admission of students. A recipient may be required to undertake additional recruitment efforts...

eHealth Recruitment Challenges

ERIC Educational Resources Information Center

Thompson, Debbe; Canada, Ashanti; Bhatt, Riddhi; Davis, Jennifer; Plesko, Lisa; Baranowski, Tom; Cullen, Karen; Zakeri, Issa

2006-01-01

Little is known about effective eHealth recruitment methods. This paper presents recruitment challenges associated with enrolling African-American girls aged 8-10 years in an eHealth obesity prevention program, their effect on the recruitment plan, and potential implications for eHealth research. Although the initial recruitment strategy was…

Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study

PubMed Central

2013-01-01

Background Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Methods/Design Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22–36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22–36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. Discussion Findings from this trial may lead to an effective

Learning Rationales and Virtual Reality Technology in Education.

ERIC Educational Resources Information Center

Chiou, Guey-Fa

1995-01-01

Defines and describes virtual reality technology and differentiates between virtual learning environment, learning material, and learning tools. Links learning rationales to virtual reality technology to pave conceptual foundations for application of virtual reality technology education. Constructivism, case-based learning, problem-based learning,…

Documenting the Engineering Design Process

ERIC Educational Resources Information Center

Hollers, Brent

2017-01-01

Documentation of ideas and the engineering design process is a critical, daily component of a professional engineer's job. While patent protection is often cited as the primary rationale for documentation, it can also benefit the engineer, the team, company, and stakeholders through creating a more rigorously designed and purposeful solution.…

In Search of Design Principles for Developing Digital Learning and Performance Support for a Student Design Task

ERIC Educational Resources Information Center

Bollen, Lars; van der Meij, Hans; Leemkuil, Henny; McKenney, Susan

2015-01-01

A digital learning and performance support environment for university student design tasks was developed. This paper describes on the design rationale, process, and the usage results to arrive at a core set of design principles for the construction of such an environment. We present a collection of organizational, technical, and course-related…

Recruitment and Selection in Business and Industry: Learning from the Private Sector Theory and Practice.

ERIC Educational Resources Information Center

Munoz, Maria D.; Munoz, Marco A.

Recruitment and selection practices in the private sector were examined through a literature review to identify strategies that human resource (HR) departments can use in designing new employee recruitment and selection processes or improving existing processes. The following were among the findings: (1) new employees recruited by using informal…

eHealth recruitment challenges.

PubMed

Thompson, Debbe; Canada, Ashanti; Bhatt, Riddhi; Davis, Jennifer; Plesko, Lisa; Baranowski, Tom; Cullen, Karen; Zakeri, Issa

2006-11-01

Little is known about effective eHealth recruitment methods. This paper presents recruitment challenges associated with enrolling African-American girls aged 8-10 years in an eHealth obesity prevention program, their effect on the recruitment plan, and potential implications for eHealth research. Although the initial recruitment strategy was literature-informed, it failed to enroll the desired number of girls within a reasonable time period. Therefore, the recruitment strategy was reformulated to incorporate principles of social marketing and traditional marketing techniques. The resulting plan included both targeted, highly specific strategies (e.g., selected churches), and more broad-based approaches (e.g., media exposure, mass mailings, radio advertisements). The revised plan enabled recruitment goals to be attained. Media appeared to be particularly effective at reaching the intended audience. Future research should identify the most effective recruitment strategies for reaching potential eHealth audiences.

Designing Design into an Advanced Desktop Publishing Course (A Teaching Tip).

ERIC Educational Resources Information Center

Guthrie, Jim

1995-01-01

Describes an advanced desktop publishing course that combines instruction in a few advanced techniques for using software with extensive discussion of such design principles as consistency, proportion, asymmetry, appropriateness, contrast, and color. Describes computer hardware and software, class assignments, problems, and the rationale for such…

Recruiting a Diverse Group of Middle School Girls Into the Trial of Activity for Adolescent Girls

PubMed Central

Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

2009-01-01

BACKGROUND School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among middle school—aged girls. TAAG provided a unique opportunity to recruit large cohorts of randomly sampled girls within 36 diverse middle schools across the United States. METHODS Key elements of the formative planning, coordination, and design of TAAG’s recruitment efforts included flexibility, tailoring, and the use of incentives. Various barriers, including a natural disaster, political tension, and district regulations, were encountered throughout the recruitment process, but coordinated strategies and frequent communication between the 6 TAAG sites were helpful in tailoring the recruitment process at the 36 intervention and control schools. RESULTS Progressively refined recruitment strategies and specific attention to the target audience of middle school girls resulted in overall study recruitment rates of 80%, 85%, and 89%, for the baseline, posttest, and follow-up period, respectively. DISCUSSION The steady increase in recruitment rates over time is attributed to an emphasis on successful strategies and a willingness to modify less successful methods. Open and consistent communication, an increasingly coordinated recruitment strategy, interactive recruitment presentations, and participant incentives resulted in an effective recruitment campaign. PMID:18808471

High-dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and design of the PANTHEON Study.

PubMed

Zheng, Jin-Ping; Wen, Fu-Qiang; Bai, Chun-Xue; Wan, Huan-Ying; Kang, Jian; Chen, Ping; Yao, Wan-Zhen; Ma, Li-Jun; Xia, Qi-Kui; Gao, Yi; Zhong, Nan-Shan

2013-04-01

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation; from a pathophysiological point of view it involves many components, including mucus hypersecretion, oxidative stress and inflammation. N-acetylcysteine (NAC) is a mucolytic agent with antioxidant and anti-inflammatory properties. Long-term efficacy of NAC 600mg/d in COPD is controversial; a dose-effect relationship has been demonstrated, but at present it is not known whether a higher dose provides clinical benefits. The PANTHEON Study is a prospective, ICS stratified, randomized, double-blind, placebo-controlled, parallel-group, multi-center trial designed to assess the efficacy and safety of high-dose (1200 mg/daily) NAC treatment for one year in moderate-to-severe COPD patients. The primary endpoint is the annual exacerbation rate. Secondary endpoints include recurrent exacerbations hazard ratio, time to first exacerbation, as well as quality of life and pulmonary function. The hypothesis, design and methodology are described and baseline characteristics of recruited patients are presented. 1006 COPD patients (444 treated with maintenance ICS, 562 ICS naive, aged 66.27±8.76 yrs, average post-bronchodilator FEV1 48.95±11.80 of predicted) have been randomized at 34 hospitals in China. Final results of this study will provide objective data on the effects of high-dose (1200 mg/daily) long-term NAC treatment in the prevention of COPD exacerbations and other outcome variables.

A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

PubMed Central

Silva, Marlene N; Markland, David; Minderico, Cláudia S; Vieira, Paulo N; Castro, Margarida M; Coutinho, Sílvia R; Santos, Teresa C; Matos, Margarida G; Sardinha, Luís B; Teixeira, Pedro J

2008-01-01

Background Research on the motivational model proposed by Self-Determination Theory (SDT) provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i) to describe a 3-year randomized controlled trial (RCT) aimed at testing a novel obesity treatment program based on SDT, and ii) to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies) are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal), recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total), and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self-regulation, influence treatment

Rationale and Roadmap for Moon Exploration

NASA Astrophysics Data System (ADS)

Foing, B. H.; ILEWG Team

We discuss the different rationale for Moon exploration. This starts with areas of scientific investigations: clues on the formation and evolution of rocky planets, accretion and bombardment in the inner solar system, comparative planetology processes (tectonic, volcanic, impact cratering, volatile delivery), records astrobiology, survival of organics; past, present and future life. The rationale includes also the advancement of instrumentation: Remote sensing miniaturised instruments; Surface geophysical and geochemistry package; Instrument deployment and robotic arm, nano-rover, sampling, drilling; Sample finder and collector. There are technologies in robotic and human exploration that are a drive for the creativity and economical competitivity of our industries: Mecha-electronics-sensors; Tele control, telepresence, virtual reality; Regional mobility rover; Autonomy and Navigation; Artificially intelligent robots, Complex systems, Man-Machine interface and performances. Moon-Mars Exploration can inspire solutions to global Earth sustained development: In-Situ Utilisation of resources; Establishment of permanent robotic infrastructures, Environmental protection aspects; Life sciences laboratories; Support to human exploration. We also report on the IAA Cosmic Study on Next Steps In Exploring Deep Space, and ongoing IAA Cosmic Studies, ILEWG/IMEWG ongoing activities, and we finally discuss possible roadmaps for robotic and human exploration, starting with the Moon-Mars missions for the coming decade, and building effectively on joint technology developments.

Prospective study of one million deaths in India: rationale, design, and validation results.

PubMed

Jha, Prabhat; Gajalakshmi, Vendhan; Gupta, Prakash C; Kumar, Rajesh; Mony, Prem; Dhingra, Neeraj; Peto, Richard

2006-02-01

Over 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity), behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history), and biological (such as blood lipids and gene polymorphisms) measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the world's largest prospective study of the causes and correlates of mortality. We will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998-2003 sample frame and 7.6 million people in 1.3 million households in the 2004-2014 sample frame) for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA) instrument. About 300,000 deaths from 1998-2003 and some 700,000 deaths from 2004-2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates. Household case-control, proportional mortality

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.

Rationale, Design, Methodology and Hospital Characteristics of the First Gulf Acute Heart Failure Registry (Gulf CARE).

PubMed

Sulaiman, Kadhim J; Panduranga, Prashanth; Al-Zakwani, Ibrahim; Alsheikh-Ali, Alawi; Al-Habib, Khalid; Al-Suwaidi, Jassim; Al-Mahmeed, Wael; Al-Faleh, Husam; El-Asfar, Abdelfatah; Al-Motarreb, Ahmed; Ridha, Mustafa; Bulbanat, Bassam; Al-Jarallah, Mohammed; Bazargani, Nooshin; Asaad, Nidal; Amin, Haitham

2014-01-01

There is paucity of data on heart failure (HF) in the Gulf Middle East. The present paper describes the rationale, design, methodology and hospital characteristics of the first Gulf acute heart failure registry (Gulf CARE). Gulf CARE is a prospective, multicenter, multinational registry of patients >18 year of age admitted with diagnosis of acute HF (AHF). The data collected included demographics, clinical characteristics, etiology, precipitating factors, management and outcomes of patients admitted with AHF. In addition, data about hospital readmission rates, procedures and mortality at 3 months and 1-year follow-up were recorded. Hospital characteristics and care provider details were collected. Data were entered in a dedicated website using an electronic case record form. A total of 5005 consecutive patients were enrolled from February 14, 2012 to November 13, 2012. Forty-seven hospitals in 7 Gulf States (Oman, Saudi Arabia, Yemen, Kuwait, United Gulf Emirates, Qatar and Bahrain) participated in the project. The majority of hospitals were community hospitals (46%; 22/47) followed by non-University teaching (32%; 15/47 and University hospitals (17%). Most of the hospitals had intensive or coronary care unit facilities (93%; 44/47) with 59% (28/47) having catheterization laboratory facilities. However, only 29% (14/47) had a dedicated HF clinic facility. Most patients (71%) were cared for by a cardiologist. Gulf CARE is the first prospective registry of AHF in the Middle East, intending to provide a unique insight into the demographics, etiology, management and outcomes of AHF in the Middle East. HF management in the Middle East is predominantly provided by cardiologists. The data obtained from this registry will help the local clinicians to identify the deficiencies in HF management as well as provide a platform to implement evidence based preventive and treatment strategies to reduce the burden of HF in this region.

Rationale, Design, Methodology and Hospital Characteristics of the First Gulf Acute Heart Failure Registry (Gulf CARE)

PubMed Central

Sulaiman, Kadhim J.; Panduranga, Prashanth; Al-Zakwani, Ibrahim; Alsheikh-Ali, Alawi; Al-Habib, Khalid; Al-Suwaidi, Jassim; Al-Mahmeed, Wael; Al-Faleh, Husam; El-Asfar, Abdelfatah; Al-Motarreb, Ahmed; Ridha, Mustafa; Bulbanat, Bassam; Al-Jarallah, Mohammed; Bazargani, Nooshin; Asaad, Nidal; Amin, Haitham

2014-01-01

Background: There is paucity of data on heart failure (HF) in the Gulf Middle East. The present paper describes the rationale, design, methodology and hospital characteristics of the first Gulf acute heart failure registry (Gulf CARE). Materials and Methods: Gulf CARE is a prospective, multicenter, multinational registry of patients >18 year of age admitted with diagnosis of acute HF (AHF). The data collected included demographics, clinical characteristics, etiology, precipitating factors, management and outcomes of patients admitted with AHF. In addition, data about hospital readmission rates, procedures and mortality at 3 months and 1-year follow-up were recorded. Hospital characteristics and care provider details were collected. Data were entered in a dedicated website using an electronic case record form. Results: A total of 5005 consecutive patients were enrolled from February 14, 2012 to November 13, 2012. Forty-seven hospitals in 7 Gulf States (Oman, Saudi Arabia, Yemen, Kuwait, United Gulf Emirates, Qatar and Bahrain) participated in the project. The majority of hospitals were community hospitals (46%; 22/47) followed by non-University teaching (32%; 15/47 and University hospitals (17%). Most of the hospitals had intensive or coronary care unit facilities (93%; 44/47) with 59% (28/47) having catheterization laboratory facilities. However, only 29% (14/47) had a dedicated HF clinic facility. Most patients (71%) were cared for by a cardiologist. Conclusions: Gulf CARE is the first prospective registry of AHF in the Middle East, intending to provide a unique insight into the demographics, etiology, management and outcomes of AHF in the Middle East. HF management in the Middle East is predominantly provided by cardiologists. The data obtained from this registry will help the local clinicians to identify the deficiencies in HF management as well as provide a platform to implement evidence based preventive and treatment strategies to reduce the burden of HF in

Talent identification and recruitment in youth soccer: Recruiter's perceptions of the key attributes for player recruitment.

PubMed

Larkin, Paul; O'Connor, Donna

2017-01-01

Using the modified Delphi method, we aimed to understand the attributes youth coaches and recruiters perceive as important when identifying skilled youth performance at the entry level of representative soccer in Australia (i.e., Under 13 years). Furthermore, we also aimed to describe the current methods youth coaches and recruiters use to assess and identify these attributes in youth players. Australian regional youth technical directors and coaches (n = 20) completed a three stage process, including an initial interview and two subsequent questionnaires, whereby attributes and qualities associated with talent identification were rated and justified according to the importance for youth player performance and talent identification. Results indicate a hierarchy of attributes recruiters perceive as important for Under 13 soccer performance, including technical (i.e., first touch, striking the ball, one-versus-one ability, and technical ability under pressure), tactical (i.e., decision-making ability) and psychological attributes (i.e., coachability and positive attitude). In addition, the findings indicated attributes and qualities not emphasised within the talent identification process including, physiological, anthropometrical, sociological and several psychological attributes. It is suggested talent recruiters apply a holistic multidisciplinary approach to talent identification, with the current findings potentially providing initial evidence to suggest recruiters do consider numerous attributes when selecting and identifying youth players.

Multicenter Trial of Rivaroxaban for Early Discharge of Pulmonary Embolism From the Emergency Department (MERCURY PE): Rationale and Design.

PubMed

Singer, Adam J; Xiang, Jim; Kabrhel, Christopher; Merli, Gino J; Pollack, Charles; Tapson, Victor F; Wildgoose, Peter; Peacock, W Frank

2016-11-01

Traditionally, patients with pulmonary embolism (PE) are admitted from the emergency department and treated with low-molecular-weight heparin followed by warfarin. Several studies now demonstrate that it is possible to identify low-risk PE patients that can safely be treated as outpatients. The advent of the direct-acting oral anticoagulants such as rivaroxaban has made it easier than ever to manage patients outside of the hospital. This article describes the design of a randomized controlled trial aimed at testing the hypothesis that low-risk PE patients can be safely and effectively managed at home using rivaroxaban, resulting in fewer days of hospitalization than standard-of-care treatment. We have initiated a multicenter, open-label, randomized clinical trial in which low-risk adult PE patients (identified by the Hestia criteria) are randomized to outpatient management with oral rivaroxaban 15 mg twice daily for 21 days followed by 20 mg once daily for 90 days versus standard care, determined by the treating physician and based on local practices. The primary clinical endpoint will be the total number of inpatient hospital days (including the index admission) for venous thromboembolic or bleeding-related events during the first 30 days after randomization. A total of 150 subjects per group will provide 82% power to detect a difference of 1 day or greater in the primary outcome. Patient enrollment is ongoing at present in 45 of 60 planned sites. No interim analysis is planned and the study is being monitored by a data safety management board. The MERCURY PE study is designed to test the hypothesis that outpatient management of low-risk PE patients with rivaroxaban reduces the number of hospitalization days from venous thromboembolism and bleeding compared with standard care. This article describes the rationale and methodology for this study. © 2016 by the Society for Academic Emergency Medicine.

Variable recruitment fluidic artificial muscles: modeling and experiments

NASA Astrophysics Data System (ADS)

Bryant, Matthew; Meller, Michael A.; Garcia, Ephrahim

2014-07-01

We investigate taking advantage of the lightweight, compliant nature of fluidic artificial muscles to create variable recruitment actuators in the form of artificial muscle bundles. Several actuator elements at different diameter scales are packaged to act as a single actuator device. The actuator elements of the bundle can be connected to the fluidic control circuit so that different groups of actuator elements, much like individual muscle fibers, can be activated independently depending on the required force output and motion. This novel actuation concept allows us to save energy by effectively impedance matching the active size of the actuators on the fly based on the instantaneous required load. This design also allows a single bundled actuator to operate in substantially different force regimes, which could be valuable for robots that need to perform a wide variety of tasks and interact safely with humans. This paper proposes, models and analyzes the actuation efficiency of this actuator concept. The analysis shows that variable recruitment operation can create an actuator that reduces throttling valve losses to operate more efficiently over a broader range of its force-strain operating space. We also present preliminary results of the design, fabrication and experimental characterization of three such bioinspired variable recruitment actuator prototypes.

Nurse forecasting in Europe (RN4CAST): Rationale, design and methodology.

PubMed

Sermeus, Walter; Aiken, Linda H; Van den Heede, Koen; Rafferty, Anne Marie; Griffiths, Peter; Moreno-Casbas, Maria Teresa; Busse, Reinhard; Lindqvist, Rikard; Scott, Anne P; Bruyneel, Luk; Brzostek, Tomasz; Kinnunen, Juha; Schubert, Maria; Schoonhoven, Lisette; Zikos, Dimitrios

2011-04-18

Current human resources planning models in nursing are unreliable and ineffective as they consider volumes, but ignore effects on quality in patient care. The project RN4CAST aims innovative forecasting methods by addressing not only volumes, but quality of nursing staff as well as quality of patient care. A multi-country, multilevel cross-sectional design is used to obtain important unmeasured factors in forecasting models including how features of hospital work environments impact on nurse recruitment, retention and patient outcomes. In each of the 12 participating European countries, at least 30 general acute hospitals were sampled. Data are gathered via four data sources (nurse, patient and organizational surveys and via routinely collected hospital discharge data). All staff nurses of a random selection of medical and surgical units (at least 2 per hospital) were surveyed. The nurse survey has the purpose to measure the experiences of nurses on their job (e.g. job satisfaction, burnout) as well as to allow the creation of aggregated hospital level measures of staffing and working conditions. The patient survey is organized in a sub-sample of countries and hospitals using a one-day census approach to measure the patient experiences with medical and nursing care. In addition to conducting a patient survey, hospital discharge abstract datasets will be used to calculate additional patient outcomes like in-hospital mortality and failure-to-rescue. Via the organizational survey, information about the organizational profile (e.g. bed size, types of technology available, teaching status) is collected to control the analyses for institutional differences.This information will be linked via common identifiers and the relationships between different aspects of the nursing work environment and patient and nurse outcomes will be studied by using multilevel regression type analyses. These results will be used to simulate the impact of changing different aspects of the

The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population

PubMed Central

Redline, Susan; Amin, Raouf; Beebe, Dean; Chervin, Ronald D.; Garetz, Susan L.; Giordani, Bruno; Marcus, Carole L.; Moore, Renee H.; Rosen, Carol L.; Arens, Raanan; Gozal, David; Katz, Eliot S.; Mitchell, Ronald B.; Muzumdar, Hiren; Taylor, H.G.; Thomas, Nina; Ellenberg, Susan

2011-01-01

Each year, over 500,000 adenotonsillectomies (AT), mostly for the treatment of pediatric obstructive sleep apnea (OSA) are performed in the US in children under 15 years of age. No definitive study, however, has been yet conducted that has rigorously evaluated the effectiveness of AT for not only improving sleep disordered breathing, but also for improving clinically relevant outcomes, such as neurocognitive function, behavior, and quality of life. The Childhood Adenotonsillectomy Trial (CHAT) was designed to assess neuropsychological and health outcomes in children randomized to receive early AT (eAT) as compared to Watchful Waiting with Supportive Care (WWSC). Important secondary goals of the study are to evaluate outcomes in subgroups defined by obesity and race. This paper addresses key elements in the design and implementation of a controlled trial for a widely used “standard practice” surgical intervention in a pediatric population, that include establishment of standardized data collection procedures across sites for a wide variety of data types, establishment of equipoise, and approaches for minimizing unblinding of selected key personnel. The study framework that was established should provide a useful template for other pediatric controlled studies or other studies that evaluate surgical interventions. Citation: Redline S; Amin R; Beebe D; Chervin RD; Garetz SL; Giordani B; Marcus CL; Moore RH; Rosen CL; Arens R; Gozal D; Katz ES; Mitchell RB; Muzumdar H; Taylor HG; Thomas N; Ellenberg S. The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population. SLEEP 2011;34(11):1509-1517. PMID:22043122

Recruitment of Participants to a Clinical Trial of Botanical Therapy for Benign Prostatic Hyperplasia

PubMed Central

Foster, Harris E.; McVary, Kevin T.; Meleth, Sreelatha; Stavris, Karen; Downey, Joe; Kusek, John W.

2011-01-01

Abstract Objectives The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy. Design CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS. Subjects The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS. Results The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms. Conclusions Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated

Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment.

PubMed

Middleton, Lee J; Daniels, Jane P; Weckesser, Annalise; Bhattacharya, Siladitya

2017-03-11

Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis. A survey of gynaecologists indicated that there was no consensus about which LARC (Levonorgestrel Intrauterine System (LNG-IUS) or depot medroxyprogesterone acetate injection (DMPA)) or comparator (combined oral contraceptive pill (COCP) or no treatment) should be evaluated. Hence, we designed a 'flexible-entry' internal pilot to assess whether a four-arm trial was feasible including a possible design adaption based on pilot findings. In this pilot, women could be randomised to two, three or four treatment options provided that one was a LARC and one was a non-LARC. An assessment of feasibility based on recruitment to these options and a revised substantive trial design was considered by an independent oversight committee. The study ran for 1 year from April 2014 and 77 women were randomised. Only 5 (6%) women accepted randomisation to all groups, with 63 (82%) having a LARC preference and 55 (71%) a non-LARC preference. Four-way and three-way designs were ruled out with a two-way LARC versus COCP design, stratified by prerandomisation choice of LARC and optional subrandomisation to LNG-IUS versus DMPA considered a feasible substantive study. Multi-arm studies are potentially efficient as they can answer multiple questions simultaneously but are difficult to recruit to if there are strong patient or clinician preferences. A flexible approach to randomisation in a pilot phase can be used to assess feasibility of such studies and modify a trial design

"Citizen Jane": Rethinking Design Principles for Closing the Gender Gap in Computing.

ERIC Educational Resources Information Center

Raphael, Chad

This paper identifies three rationales in the relevant literature for closing the gender gap in computing: economic, cultural and political. Each rationale implies a different set of indicators of present inequalities, disparate goals for creating equality, and distinct principles for software and web site design that aims to help girls overcome…

Invitation to the Birthday Party: Rationale and Description

ERIC Educational Resources Information Center

Ginsburg, Herbert P.; Pappas, Sandra

2016-01-01

Educators in many countries around the world have a strong interest in improving early childhood mathematics education, one component of which is formative assessment. Unlike summative assessment, this approach can provide teachers with information useful for understanding and teaching individual children. This paper describes the rationale for…

A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial

PubMed Central

Deeks, Jonathan J; Griffith, Michael; Lip, Gregory YH; Mehta, Samir; Slinn, Gemma; Stanbury, Mary; Steeds, Richard P; Townend, Jonathan N

2017-01-01

Background and objective Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article, we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity. Such a trial should concentrate on the long-term effects of treatment in the largest proportion of patients with AF, those with symptomatic permanent AF, with the aim of improving patient well-being. Design and intervention The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial will enrol 160 participants with a prospective, randomised, open-label, blinded end point design comparing initial rate control with digoxin or bisoprolol. This will be the first head-to-head randomised trial of digoxin and beta-blockers in AF. Participants Recruited patients will be aged ≥60 years with permanent AF and symptoms of breathlessness (equivalent to New York Heart Association class II or above), with few exclusion criteria to maximise generalisability to routine clinical practice. Outcome measures The primary outcome is patient-reported quality of life, with secondary outcomes including echocardiographic ventricular function, exercise capacity and biomarkers of cellular and clinical response. Follow-up will occur at 6 and 12 months, with feasibility components to inform the design of a future trial powered to detect a difference in hospital admission. The RATE-AF trial will underpin an integrated approach to management including biomarkers, functions and symptoms that will guide future research into optimal, personalised rate control in patients with AF. Ethics and dissemination

Evaluation of conceptual framework for recruitment of African American patients with breast cancer.

PubMed

Heiney, Sue P; Adams, Swann Arp; Wells, Linda M; Johnson, Hiluv

2010-05-01

To describe the Heiney-Adams Recruitment Framework (H-ARF); to delineate a recruitment plan for a randomized, behavioral trial (RBT) based on H-ARF; and to provide evaluation data on its implementation. All data for this investigation originated from a recruitment database created for an RBT designed to test the effectiveness of a therapeutic group convened via teleconference for African American women with breast cancer. Major H-ARF concepts include social marketing and relationship building. The majority of social marketing strategies yielded 100% participant recruitment. Greater absolute numbers were recruited via Health Insurance Portability and Accountability Act waivers. Using H-ARF yielded a high recruitment rate (66%). Application of H-ARF led to successful recruitment in an RBT. The findings highlight three areas that researchers should consider when devising recruitment plans: absolute numbers versus recruitment rate, cost, and efficiency with institutional review board-approved access to protected health information. H-ARF may be applied to any clinical or population-based research setting because it provides direction for researchers to develop a recruitment plan based on the target audience and cultural attributes that may hinder or help recruitment.

Evaluation of Conceptual Framework for Recruitment of African American Patients With Breast Cancer

PubMed Central

Heiney, Sue P.; Adams, Swann Arp; Wells, Linda M.; Johnson, Hiluv

2010-01-01

Purpose/Objectives To describe the Heiney-Adams Recruitment Framework (H-ARF); to delineate a recruitment plan for a randomized, behavioral trial (RBT) based on H-ARF; and to provide evaluation data on its implementation. Data Sources All data for this investigation originated from a recruitment database created for an RBT designed to test the effectiveness of a therapeutic group convened via teleconference for African American women with breast cancer. Data Synthesis Major H-ARF concepts include social marketing and relationship building. The majority of social marketing strategies yielded 100% participant recruitment. Greater absolute numbers were recruited via Health Insurance Portability and Accountability Act waivers. Using H-ARF yielded a high recruitment rate (66%). Conclusions Application of H-ARF led to successful recruitment in an RBT. The findings highlight three areas that researchers should consider when devising recruitment plans: absolute numbers versus recruitment rate, cost, and efficiency with institutional review board–approved access to protected health information. Implications for Nursing H-ARF may be applied to any clinical or population-based research setting because it provides direction for researchers to develop a recruitment plan based on the target audience and cultural attributes that may hinder or help recruitment. PMID:20439201

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

PubMed

Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

2016-03-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. Published by Elsevier Inc.

Rationale and Design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

PubMed Central

Hedayati, S. Susan; Daniel, Divya M.; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M.; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L.; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H.; Unruh, Mark; Weisbord, Steven; Young, Bessie A.; Mehrotra, Rajnish

2015-01-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. PMID:26621218

A survey of facilitators and barriers to recruitment to the MAGNETIC trial.

PubMed

Kaur, Geetinder; Smyth, Rosalind L; Powell, Colin V E; Williamson, Paula

2016-12-23

Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool. MAGNETIC is a multicentre randomised trial of nebulised magnesium in acute severe asthma, recruiting 508 children from 30 UK sites. Recruiters were asked to grade a list of factors from -3 to +3 depending on whether the factor was perceived as a strong, intermediate or weak barrier (-3 to -1) or facilitator (+1 to + 3), and using (0) if it was thought to be not applicable. Free text responses were invited on strategies applied to counter the identified barriers. The commonly identified facilitators were motivation and experience of study teams, effective communication and coordination between teams at site and between sites and the Clinical Trials Unit, the presence of designated research nurses, good trial management, clinical trial publicity, simple inclusion criteria, effective communication with parents and presentation of trial information in a simple and clear manner. The commonly identified barriers were heavy clinical workload, shift patterns of work, Good Clinical Practice (GCP) training, inadequate number of trained staff, time and setting of consent seeking, non-availability of research staff out of hours and parents' concerns about their child taking an experimental medicine. Having a designated research nurse, arranging GCP training and trial-related training sessions for staff were the most commonly reported interventions. This study highlights important generic and trial-specific facilitators and barriers to recruitment to a paediatric trial in the acute setting and provides information on the recruitment strategies or interventions that were applied to overcome these barriers. This information can be very useful in informing the design

A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment.

PubMed

Hampson, Lisa V; Williamson, Paula R; Wilby, Martin J; Jaki, Thomas

2017-01-01

Just over half of publicly funded trials recruit their target sample size within the planned study duration. When recruitment targets are missed, the funder of a trial is faced with the decision of either committing further resources to the study or risk that a worthwhile treatment effect may be missed by an underpowered final analysis. To avoid this challenging situation, when there is insufficient prior evidence to support predicted recruitment rates, funders now require feasibility assessments to be performed in the early stages of trials. Progression criteria are usually specified and agreed with the funder ahead of time. To date, however, the progression rules used are typically ad hoc. In addition, rules routinely permit adaptations to recruitment strategies but do not stipulate criteria for evaluating their effectiveness. In this paper, we develop a framework for planning and designing internal pilot studies which permit a trial to be stopped early if recruitment is disappointing or to continue to full recruitment if enrolment during the feasibility phase is adequate. This framework enables a progression rule to be pre-specified and agreed upon prior to starting a trial. The novel two-stage designs stipulate that if neither of these situations arises, adaptations to recruitment should be made and subsequently evaluated to establish whether they have been successful. We derive optimal progression rules for internal pilot studies which minimise the expected trial overrun and maintain a high probability of completing the study when the recruitment rate is adequate. The advantages of this procedure are illustrated using a real trial example.

Making the most of on-line recruiting.

PubMed

Cappelli, P

2001-03-01

Ninety percent of large U.S. companies are already recruiting via the Internet. By simply logging on to the Web, company recruiters can locate vast numbers of qualified candidates for jobs at every level, screen them in minutes, and contact the most promising ones immediately. The payoffs can be enormous: it costs substantially less to hire someone on-line, and the time saved is equally great. In this article, Peter Cappelli examines some of the emerging service providers and technologies--matchmakers, job boards, hiring management systems software, and applicant-screening mechanisms that test skills and record interests. He also looks at some of the strategies companies are adopting as they enter on-line labor markets. Recruiting needs to be refashioned to resemble marketing, he stresses. Accordingly, smart companies are designing Web pages, and even product ads, with potential recruits in mind. They're giving line managers authority to hire so that candidates in cyberspace aren't lost. They're building internal on-line job networks to retain talent. Integrating recruiting efforts with overall marketing campaigns, especially through coordination and identification with the company's brand, is the most important thing companies can do to ensure success in on-line hiring. Along the way, Cappelli sounds two cautionary notes. First, a human touch, not electronic contact, is vital in the last steps of a successful hiring process. Second, companies must make sure that on-line testing and hiring criteria do not discriminate against women, disabled people, workers over 40, or members of minority groups. When competition for talent is fierce, companies that master the art and science of on-line recruiting will be the ones that attract and keep the best people.

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

Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

PubMed

Berry, Diane C; Neal, Madeline; Hall, Emily G; Schwartz, Todd A; Verbiest, Sarah; Bonuck, Karen; Goodnight, William; Brody, Seth; Dorman, Karen F; Menard, Mary K; Stuebe, Alison M

2013-10-10

Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to

Overcoming recruitment challenges in construction safety intervention research.

PubMed

Kidd, Pamela; Parshall, Mark; Wojcik, Susan; Struttmann, Tim

2004-03-01

Recruiting workers in small construction companies and securing their participation in voluntary safety programs or safety research poses unique challenges. Worker turnover and worksite changes contribute to difficulties in locating and enrolling participants. Economic pressures and time demands potentially threaten ongoing participation. Six simulation exercises designed to reduce back and fall injuries in small construction companies were developed based on data from focus groups of workers and company owners. Working with a workers' compensation insurer, we had access to owner-operators of general, heavy, and special trade construction companies reporting less than $10,000 in payroll expenses. Recruitment methods included a participation incentive, mailed invitations followed by phone contacts, and follow-up reminders. Despite using recruitment methods recommended in the literature, participation rates were low over a 2-year intervention period. Because of these difficulties, factors affecting participation or nonparticipation became an additional research focus. Owners' perceptions of already having a good safety record and of the time demands of participation were the most commonly cited reasons for not participating. Literature on recruitment emphasizes processes and procedures under investigator control rather than understanding potential participants' judgments about the adequacy of their existing practices and the potential benefits of intervention participation relative to potential time and productivity trade-offs. Greater attention to such judgments may enhance recruitment and participation in under-studied and difficult to access populations. Copyright 2004 Wiley-Liss, Inc.

ABE Outreach: Teacher, Recruiter, Counselor. A Handbook for Adult Basic Education Teacher/Recruiter/Counselors. A Guide for Program Managers. Revised.

ERIC Educational Resources Information Center

Singer, Elizabeth W.

Designed for program managers and teacher/recruiter/counselors (TRC's), this handbook provides information on Brevard Community College's Adult Basic Education (ABE) Outreach program. First, background information on the ABE/TRC concept is presented, identifying the major functions of the TRC as counseling through door-to-door contact, conducting…

22 CFR 229.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Recruitment. 229.310 Section 229.310 Foreign... and Recruitment Prohibited § 229.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 229.300 through 229.310 apply shall not discriminate on the basis of sex in the recruitment and...

49 CFR 25.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Recruitment. 25.310 Section 25.310 Transportation... Recruitment Prohibited § 25.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 25.300 through 25.310 apply shall not discriminate on the basis of sex in the recruitment and admission of...

10 CFR 1042.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Recruitment. 1042.310 Section 1042.310 Energy DEPARTMENT... Recruitment Prohibited § 1042.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 1042.300 through 1042.310 apply shall not discriminate on the basis of sex in the recruitment and admission...

Recruitment for radiologic technologists.

PubMed

Fodor, J

1988-01-01

The increasing shortage of radiologic technologists makes the recruiting of new staff more important than ever. This paper introduces the manager to numerous recruiting concepts and discusses some useful strategies to employ when approaching the important recruiting task.

Structure, Citizenship, and Professionalism: Exploring Rationale Development as Part of Graduate Education in Social Studies

ERIC Educational Resources Information Center

Hawley, Todd S.; Pifel, A. Robert; Jordan, Adam W.

2012-01-01

This article details an interpretive, qualitative interview study that explored rationales developed by seven social studies graduate students, all experienced teachers, at a large Midwestern university. Interviews revealed three common themes regarding the influence of the rationale development process. The three themes were: providing structure,…

From loquacious to reticent: understanding patient health information communication to guide consumer health IT design.

PubMed

Valdez, Rupa S; Guterbock, Thomas M; Fitzgibbon, Kara; Williams, Ishan C; Wellbeloved-Stone, Claire A; Bears, Jaime E; Menefee, Hannah K

2017-07-01

It is increasingly recognized that some patients self-manage in the context of social networks rather than alone. Consumer health information technology (IT) designed to support socially embedded self-management must be responsive to patients' everyday communication practices. There is an opportunity to improve consumer health IT design by explicating how patients currently leverage social media to support health information communication. The objective of this study was to determine types of health information communication patterns that typify Facebook users with chronic health conditions to guide consumer health IT design. Seven hundred participants with type 2 diabetes were recruited through a commercial survey access panel. Cluster analysis was used to identify distinct approaches to health information communication both on and off Facebook. Analysis of variance (ANOVA) methods were used to identify demographic and behavioral differences among profiles. Secondary analysis of qualitative interviews ( n  = 25) and analysis of open-ended survey questions were conducted to understand participant rationales for each profile. Our analysis yielded 7 distinct health information communication profiles. Five of 7 profiles had consistent patterns both on and off Facebook, while the remaining 2 demonstrated distinct practices, with no health information communication on Facebook but some off Facebook. One profile was distinct from all others in both health information communication practices and demographic composition. Rationales for following specific health information communication practices were categorized under 6 themes: altruism, instrumental support, social support, privacy and stigma, convenience, and Facebook knowledge. Facebook has been widely adopted for health information communication; This study demonstrates that Facebook has been widely adopted for health information communication. It also shows that the ways in which patients communicate health

Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.

PubMed

Riddler, Sharon A; Husnik, Marla; Gorbach, Pamina M; Levy, Lisa; Parikh, Urvi; Livant, Edward; Pather, Arendevi; Makanani, Bonus; Muhlanga, Felix; Kasaro, Margaret; Martinson, Francis; Elharrar, Vanessa; Balkus, Jennifer E

2016-09-01

As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort. Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing. MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness. Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.

Pilot Aircraft Interface Objectives/Rationale

NASA Technical Reports Server (NTRS)

Shively, Jay

2010-01-01

Objective: Database and proof of concept for guidelines for GCS compliance a) Rationale: 1) Provide research test-bed to develop guidelines. 2) Modify GCS for NAS Compliance to provide proof of concept. b) Approach: 1) Assess current state of GCS technology. 2) Information Requirements Definition. 3) SME Workshop. 4) Modify an Existing GCS for NAS Compliance. 5) Define exemplar UAS (choose system to develop prototype). 6) Define Candidate Displays & Controls. 7) Evaluate/ refine in Simulations. 8) Demonstrate in flight. c) Deliverables: 1) Information Requirements Report. 2) Workshop Proceedings. 3) Technical Reports/ papers on Simulations & Flight Demo. 4) Database for guidelines.

Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study

PubMed Central

Babiker, Abdel G; Emery, Sean; Fätkenheuer, Gerd; Gordin, Fred M; Grund, Birgit; Lundgren, Jens D; Neaton, James D; Pett, Sarah L; Phillips, Andrew; Touloumi, Giota; Vjecha, Michael J

2012-01-01

Background Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development of opportunistic diseases (acquired immunodeficiency syndrome (AIDS)), and more recent data suggest that HIV is also associated with an increased risk of serious non-AIDS (SNA) diseases including cardiovascular, renal, and liver diseases and non-AIDS-defining cancers. Although combination antiretroviral treatment (ART) has resulted in a substantial decrease in morbidity and mortality in persons with HIV infection, viral eradication is not feasible with currently available drugs. The optimal time to start ART for asymptomatic HIV infection is controversial and remains one of the key unanswered questions in the clinical management of HIV-infected individuals. Purpose In this article, we outline the rationale and methods of the Strategic Timing of AntiRetroviral Treatment (START) study, an ongoing multicenter international trial designed to assess the risks and benefits of initiating ART earlier than is currently practiced. We also describe some of the challenges encountered in the design and implementation of the study and how these challenges were addressed. Methods A total of 4000 study participants who are HIV type 1 (HIV-1) infected, ART naïve with CD4 count > 500 cells/μL are to be randomly allocated in a 1:1 ratio to start ART immediately (early ART) or defer treatment until CD4 count is <350 cells/ μL (deferred ART) and followed for a minimum of 3 years. The primary outcome is time to AIDS, SNA, or death. The study had a pilot phase to establish feasibility of accrual, which was set as the enrollment of at least 900 participants in the first year. Results Challenges encountered in the design and implementation of the study included the limited amount of data on the risk of a major component of the primary endpoint (SNA) in the study population, changes in treatment guidelines when the pilot

Building "Applied Linguistic Historiography": Rationale, Scope, and Methods

ERIC Educational Resources Information Center

Smith, Richard

2016-01-01

In this article I argue for the establishment of "Applied Linguistic Historiography" (ALH), that is, a new domain of enquiry within applied linguistics involving a rigorous, scholarly, and self-reflexive approach to historical research. Considering issues of rationale, scope, and methods in turn, I provide reasons why ALH is needed and…

Logistic Approximation to the Normal: The KL Rationale

ERIC Educational Resources Information Center

Savalei, Victoria

2006-01-01

A rationale is proposed for approximating the normal distribution with a logistic distribution using a scaling constant based on minimizing the Kullback-Leibler (KL) information, that is, the expected amount of information available in a sample to distinguish between two competing distributions using a likelihood ratio (LR) test, assuming one of…

Recruitment of motor units in the medial gastrocnemius muscle during human quiet standing: is recruitment intermittent? What triggers recruitment?

PubMed Central

Loram, Ian D.; Muceli, Silvia; Merletti, Roberto; Farina, Dario

2012-01-01

The recruitment and the rate of discharge of motor units are determinants of muscle force. Within a motoneuron pool, recruitment and rate coding of individual motor units might be controlled independently, depending on the circumstances. In this study, we tested whether, during human quiet standing, the force of the medial gastrocnemius (MG) muscle is predominantly controlled by recruitment or rate coding. If MG control during standing was mainly due to recruitment, then we further asked what the trigger mechanism is. Is it determined internally, or is it related to body kinematics? While seven healthy subjects stood quietly, intramuscular electromyograms were recorded from the MG muscle with three pairs of wire electrodes. The number of active motor units and their mean discharge rate were compared for different sway velocities and positions. Motor unit discharges occurred more frequently when the body swayed faster and forward (Pearson R = 0.63; P < 0.0001). This higher likelihood of observing motor unit potentials was explained chiefly by the recruitment of additional units. During forward body shifts, the median number of units detected increased from 3 to 11 (P < 0.0001), whereas the discharge rate changed from 8 ± 1.1 (mean ± SD) to 10 ± 0.9 pulses/s (P = 0.001). Strikingly, motor units did not discharge continuously throughout standing. They were recruited within individual, forward sways and intermittently, with a modal rate of two recruitments per second. This modal rate is consistent with previous circumstantial evidence relating the control of standing to an intrinsic, higher level planning process. PMID:21994258

Recruitment of motor units in the medial gastrocnemius muscle during human quiet standing: is recruitment intermittent? What triggers recruitment?

PubMed

Vieira, Taian M M; Loram, Ian D; Muceli, Silvia; Merletti, Roberto; Farina, Dario

2012-01-01

The recruitment and the rate of discharge of motor units are determinants of muscle force. Within a motoneuron pool, recruitment and rate coding of individual motor units might be controlled independently, depending on the circumstances. In this study, we tested whether, during human quiet standing, the force of the medial gastrocnemius (MG) muscle is predominantly controlled by recruitment or rate coding. If MG control during standing was mainly due to recruitment, then we further asked what the trigger mechanism is. Is it determined internally, or is it related to body kinematics? While seven healthy subjects stood quietly, intramuscular electromyograms were recorded from the MG muscle with three pairs of wire electrodes. The number of active motor units and their mean discharge rate were compared for different sway velocities and positions. Motor unit discharges occurred more frequently when the body swayed faster and forward (Pearson R = 0.63; P < 0.0001). This higher likelihood of observing motor unit potentials was explained chiefly by the recruitment of additional units. During forward body shifts, the median number of units detected increased from 3 to 11 (P < 0.0001), whereas the discharge rate changed from 8 ± 1.1 (mean ± SD) to 10 ± 0.9 pulses/s (P = 0.001). Strikingly, motor units did not discharge continuously throughout standing. They were recruited within individual, forward sways and intermittently, with a modal rate of two recruitments per second. This modal rate is consistent with previous circumstantial evidence relating the control of standing to an intrinsic, higher level planning process.

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

PubMed

Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

2015-09-11

Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

A community-based obesity prevention program for minority children: rationale and study design for Hip-Hop to Health Jr.

PubMed

Fitzgibbon, Marian L; Stolley, Melinda R; Dyer, Alan R; VanHorn, Linda; KauferChristoffel, Katherine

2002-02-01

BACKGROUND; The increasing prevalence of overweight among children in the United States presents a national health priority. Higher rates of overweight/obesity among minority women place their children at increased risk. Although increased rates of overweight are observed in 4- to 5-year-old children, they are not observed in 2- to 3-year-old children. Therefore, early prevention efforts incorporating families are critical. The primary aim of Hip-Hop to Health Jr. is to alter the trajectory toward overweight/obesity among preschool African-American and Latino children. This 5-year randomized intervention is conducted in 24 Head Start programs, where each site is randomized to either a 14-week dietary/physical activity intervention or a general health intervention. This paper presents the rationale and design of the study. Efficacy of the intervention will be determined by weight change for the children and parent/caretaker. Secondary measures include reductions in dietary fat and increases in fiber, fruit/vegetable intake, and physical activity. Baseline data will be presented in future papers. The problem of overweight/obesity is epidemic in the United States. Behaviors related to diet and physical activity are established early in life and modeled by family members. Early intervention efforts addressing the child and family are needed to prevent obesity later in life. This paper describes a comprehensive, family-oriented obesity prevention program for minority preschool children. Copyright 2002 American Health Foundation and Elsevier Science (USA).

"ComPost": A Writing Program Newsletter and Its Rationale.

ERIC Educational Resources Information Center

Hall, Dennis R.

1993-01-01

Discusses the development and rationale of "ComPost," a weekly newsletter of the Composition Program at the University of Louisville. Suggests that a vehicle like ComPost can promote the communications that contribute to accomplishing collegiality and genuine program consensus. (RS)

Soft Power as a Policy Rationale for International Education in the UK: A Critical Analysis

ERIC Educational Resources Information Center

Lomer, Sylvie

2017-01-01

This article presents the results of a textual analysis conducted on policy discourses on international students in the UK between 1999 and 2013. A number of rationales for and against increasing their numbers have been made, which have largely remained consistent over changing political administrations. One key rationale is that international…

Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment.

PubMed

Hubbard, Gill; Campbell, Anna; Davies, Zoe; Munro, Julie; Ireland, Aileen V; Leslie, Stephen; Watson, Angus Jm; Treweek, Shaun

2015-01-01

Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation. Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used:Nurse assessed patients for eligibility.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group. Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded. There were variations in the time taken to award Research Management approval to run the study at the three sites (45-359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation. Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial's recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and

Clinical trials: the challenge of recruitment and retention of participants.

PubMed

Gul, Raisa B; Ali, Parveen A

2010-01-01

conceptual thinking as part of the research design. An understanding of the challenges and issues related to recruitment and retention can help researchers to think ahead about the strategies to overcome these issues and consequently save the time and energy of the participants, researchers and funding agencies.

Recruitment and Training. Symposium.

ERIC Educational Resources Information Center

2002

This document contains three papers from a symposium on recruitment and training. "College Choice: The State of Marketing and Effective Student Recruitment Strategies" (Fredrick Muyia Nafukho, Michael F. Burnett) reports on a study of the recruitment strategies used by Louisiana State University's admissions office and College of…

Exploring recruitment issues in stroke research: a qualitative study of nurse researchers' experiences.

PubMed

Boxall, Leigh; Hemsley, Anthony; White, Nicola

2016-05-01

To explore the practice of experienced stroke nurse researchers to understand the issues they face in recruiting participants. Participant recruitment is one of the greatest challenges in conducting clinical research, with many trials failing due to recruitment problems. Stroke research is a particularly difficult area in which to recruit; however various strategies can improve participation. Analysis revealed three main types of problems for recruiting participants to stroke research: those related to patients, those related to the nurse researcher, and those related to the study itself. Impairments affecting capacity to consent, the acute recruitment time frame of most stroke trials, paternalism by nurse researchers, and low public awareness were especially pertinent. The disabling nature of a stroke, which often includes functional and cognitive impairments, and the acute stage of illness at which patients are appropriate for many trials, make recruiting patients particularly complex and challenging. An awareness of the issues surrounding the recruitment of stroke patients may help researchers in designing and conducting trials. Future work is needed to address the complexities of obtaining informed consent when patient capacity is compromised.

Market Failures and the Rationale for National Parks.

ERIC Educational Resources Information Center

Turner, Robert W.

2002-01-01

Discusses how market failures can, in principle, be used to justify national parks. States the best rationale is based on existence or nonuse values instead of the recreational aspects. Shows more evidence (costs of providing and operating the parks and the magnitude of nonuse values) is needed before the case becomes compelling. (JEH)

Recruitment efforts to reduce adverse impact: targeted recruiting for personality, cognitive ability, and diversity.

PubMed

Newman, Daniel A; Lyon, Julie S

2009-03-01

Noting the presumed tradeoff between diversity and performance goals in contemporary selection practice, the authors elaborate on recruiting-based methods for avoiding adverse impact while maintaining aggregate individual productivity. To extend earlier work on the primacy of applicant pool characteristics for resolving adverse impact, they illustrate the advantages of simultaneous cognitive ability- and personality-based recruiting. Results of an algebraic recruiting model support general recruiting for cognitive ability, combined with recruiting for conscientiousness within the underrepresented group. For realistic recruiting effect sizes, this type of recruiting strategy greatly increases average performance of hires and percentage of hires from the underrepresented group. Further results from a policy-capturing study provide initial guidance on how features of organizational image can attract applicants with particular job-related personalities and abilities, in addition to attracting applicants on the basis of demographic background. (c) 2009 APA, all rights reserved.

The Cohort for Childhood Origin of Asthma and allergic diseases (COCOA) study: design, rationale and methods.

PubMed

Yang, Hyeon-Jong; Lee, So-Yeon; Suh, Dong In; Shin, Youn Ho; Kim, Byoung-Ju; Seo, Ju-Hee; Chang, Hyoung Yoon; Kim, Kyung Won; Ahn, Kangmo; Shin, Yee-Jin; Lee, Kyung-Sook; Lee, Cheol Min; Oh, Se-Young; Kim, Ho; Leem, Jong-Han; Kim, Hwan-Cheol; Kim, Eun-Jin; Lee, Joo-Shil; Hong, Soo-Jong

2014-07-03

This paper describes the background, aim, and design of a prospective birth-cohort study in Korea called the COhort for Childhood Origin of Asthma and allergic diseases (COCOA). COCOA objectives are to investigate the individual and interactive effects of genetics, perinatal environment, maternal lifestyle, and psychosocial stress of mother and child on pediatric susceptibility to allergic diseases. The participants in COCOA represents a Korean inner-city population. Recruitment started on 19 November, 2007 and will continue until 31 December, 2015. Recruitment is performed at five medical centers and eight public-health centers for antenatal care located in Seoul. Participating mother-baby pairs are followed from before birth to adolescents. COCOA investigates whether the following five environmental variables contribute causally to the development and natural course of allergic diseases: (1) perinatal indoor factors (i.e. house-dust mite, bacterial endotoxin, tobacco smoking, and particulate matters 2.5 and 10), (2) perinatal outdoor pollutants, (3) maternal prenatal psychosocial stress and the child's neurodevelopment, (4) perinatal nutrition, and (5) perinatal microbiome. Cord blood and blood samples from the child are used to assess whether the child's genes and epigenetic changes influence allergic-disease susceptibility. Thus, COCOA aims to investigate the contributions of genetics, epigenetics, and various environmental factors in early life to allergic-disease susceptibility in later life. How these variables interact to shape allergic-disease susceptibility is also a key aim.The COCOA data collection schedule includes 11 routine standardized follow-up assessments of all children at 6 months and every year until 10 years of age, regardless of allergic-disease development. The mothers will complete multiple questionnaires to assess the baseline characteristics, the child's exposure to environmental factors, maternal pre- and post-natal psychological stress

Overcoming recruitment challenges in palliative care clinical trials.

PubMed

LeBlanc, Thomas W; Lodato, Jordan E; Currow, David C; Abernethy, Amy P

2013-11-01

Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study. The PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications. From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%). Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.

What Is Implementation Research? Rationale, Concepts, and Practices

ERIC Educational Resources Information Center

Bhattacharyya, Onil; Reeves, Scott; Zwarenstein, Merrick

2009-01-01

Despite the growing knowledge base on evidence-based practices in social work and medicine, there is a large gap between what is known and what is consistently done. Implementation research is the study of methods to promote the uptake of research findings into routine practice. In this article, we describe the rationale for implementation…

28 CFR 54.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Recruitment. 54.510 Section 54.510... in Employment in Education Programs or Activities Prohibited § 54.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

41 CFR 101-4.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 2 2010-07-01 2010-07-01 true Recruitment. 101-4.310... Admission and Recruitment Prohibited § 101-4.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient... recruitment and admission of students. A recipient may be required to undertake additional recruitment efforts...

Cue-recruitment for extrinsic signals after training with low information stimuli.

PubMed

Jain, Anshul; Fuller, Stuart; Backus, Benjamin T

2014-01-01

Cue-recruitment occurs when a previously ineffective signal comes to affect the perceptual appearance of a target object, in a manner similar to the trusted cues with which the signal was put into correlation during training. Jain, Fuller and Backus reported that extrinsic signals, those not carried by the target object itself, were not recruited even after extensive training. However, recent studies have shown that training using weakened trusted cues can facilitate recruitment of intrinsic signals. The current study was designed to examine whether extrinsic signals can be recruited by putting them in correlation with weakened trusted cues. Specifically, we tested whether an extrinsic visual signal, the rotary motion direction of an annulus of random dots, and an extrinsic auditory signal, direction of an auditory pitch glide, can be recruited as cues for the rotation direction of a Necker cube. We found learning, albeit weak, for visual but not for auditory signals. These results extend the generality of the cue-recruitment phenomenon to an extrinsic signal and provide further evidence that the visual system learns to use new signals most quickly when other, long-trusted cues are unavailable or unreliable.

Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team.

PubMed

Ho, M W; Pick, A S; Sutton, D N; Dyker, K; Cardale, K; Gilbert, K; Johnson, J; Quantrill, J; McCaul, J A

2018-05-01

We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009-2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and "step-up" randomisation with "non-inferiority" randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach.

PubMed

Amorrortu, Rossybelle P; Arevalo, Mariana; Vernon, Sally W; Mainous, Arch G; Diaz, Vanessa; McKee, M Diane; Ford, Marvella E; Tilley, Barbara C

2018-02-17

Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers' ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan. The intervention included five educational modules, one in-person and four web-based, plus technical assistance calls to coordinators. Modules addressed the intervention rationale, development of clinic-specific plans to obtain minority-serving physician referrals, physician-centered and patient-centered communication, and patient navigation. The evaluation, a randomized trial, was recently completed in 50 specialty clinics and is under analysis. Using IM we developed a recruitment intervention that focused on building relationships with minority-serving physicians to encourage minority patient referrals. IM enhanced our understanding of factors that may influence minority recruitment and helped us integrate strategies from multiple disciplines that were relevant for our audience.

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.

49 CFR 25.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Recruitment. 25.510 Section 25.510 Transportation... Education Programs or Activities Prohibited § 25.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees...

43 CFR 41.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Recruitment. 41.510 Section 41.510 Public... in Employment in Education Programs or Activities Prohibited § 41.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

44 CFR 19.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Recruitment. 19.510 Section... Programs or Activities Prohibited § 19.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a...

10 CFR 1042.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Recruitment. 1042.510 Section 1042.510 Energy DEPARTMENT... Education Programs or Activities Prohibited § 1042.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees...

6 CFR 17.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 6 Domestic Security 1 2010-01-01 2010-01-01 false Recruitment. 17.510 Section 17.510 Domestic... in Employment in Education Programs or Activities Prohibited § 17.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

45 CFR 86.53 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Recruitment. 86.53 Section 86.53 Public Welfare... in Employment in Education Programs or Activities Prohibited § 86.53 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

14 CFR 1253.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Recruitment. 1253.510 Section 1253.510... in Employment in Education Programs or Activities Prohibited § 1253.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

34 CFR 106.53 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Recruitment. 106.53 Section 106.53 Education... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

44 CFR 19.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Recruitment. 19.310 Section... RECEIVING FEDERAL FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 19.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 19.300 through 19...

Natural Resource Information System, design analysis

NASA Technical Reports Server (NTRS)

1972-01-01

The computer-based system stores, processes, and displays map data relating to natural resources. The system was designed on the basis of requirements established in a user survey and an analysis of decision flow. The design analysis effort is described, and the rationale behind major design decisions, including map processing, cell vs. polygon, choice of classification systems, mapping accuracy, system hardware, and software language is summarized.

15 CFR 8a.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Recruitment. 8a.310 Section 8a.310... in Admission and Recruitment Prohibited § 8a.310 Recruitment. (a) Nondiscriminatory recruitment. A... recruitment and admission of students. A recipient may be required to undertake additional recruitment efforts...

An Analysis of Recruit Training Attrition in the U.S. Marine Corps

DTIC Science & Technology

1978-02-01

direct ir-licatimns for tt.e recruit-r..t. sel)(tion, arJ organizational entry process . To the extent potential recr-uits can :e given accurate...assimilation-socialization process (Graen, 1976) as it influences these and other variables and as this process relates to attrition. Summnarizing the...considers both individual and organizational variables; c) Combined with a longitudinal design, it permits assessment of the learning-socialization process

Strategies to improve recruitment to randomised trials.

PubMed

Treweek, Shaun; Pitkethly, Marie; Cook, Jonathan; Fraser, Cynthia; Mitchell, Elizabeth; Sullivan, Frank; Jackson, Catherine; Taskila, Tyna K; Gardner, Heidi

2018-02-22

health care.We found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI -1% to 3%).We had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.We had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones. The literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology

45 CFR 618.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Recruitment. 618.510 Section 618.510 Public... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

13 CFR 113.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Recruitment. 113.510 Section 113... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

45 CFR 2555.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Recruitment. 2555.510 Section 2555.510 Public... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

18 CFR 1317.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Recruitment. 1317.510... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

32 CFR 196.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 2 2010-07-01 2010-07-01 false Recruitment. 196.510 Section 196.510 National... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

34 CFR 106.23 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Recruitment. 106.23 Section 106.23 Education... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 106.23 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which this subpart applies shall not discriminate on the basis of sex...

24 CFR 3.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Recruitment. 3.510 Section 3.510... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

36 CFR 1211.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Recruitment. 1211.510 Section... Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found to be presently...

Recruitment of participants to a multiple sclerosis trial: The CombiRx experience

PubMed Central

Bhanushali, Minal J; Gustafson, Tarah; Powell, Steve; Conwit, Robin A; Wolinsky, Jerry S; Cutter, Gary R; Lublin, Fred; Cofield, Stacey S

2014-01-01

Background and Purpose: Participant recruitment is central to all clinical trials. Any delay in recruitment affects the completion and ultimate success of the trial. We report our experience with patient screening and randomization in CombiRx, which may inform the design of other trials. CombiRx was a multi-center, phase III, double-blind, randomized clinical trial comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in patients with relapsing-remitting multiple sclerosis (RRMS). This trial was launched in January 2005 in 69 centers in the U.S. and Canada under a co-operative agreement with the National Institute of Neurological Disorders and Stroke (NINDS). The goal was to recruit 1000 patients over 1.5 years after a 6 month startup period. Instead, the investigators required 4.25 years to enroll 1008 patients. Methods: During this trial, we assessed the effectiveness of various recruitment strategies, utility of rescreening prior screen failures, and potential factors and strategies used in study conduct, research and infrastructure, all of which affected recruitment of participants and ultimately time to completion of CombiRx. We particularly were interested in the variability in time to site initiation between academic centers and private practice sites. Results: Physicians who were directly involved in the medical care of patients with RRMS were the primary source of patients recruited to CombiRx. A flexible study design that allowed for re-screening of the initial screen failures after a period of time was useful due to the relapsing/remitting course of the disease. Academic centers took longer to implement the trial than the private practice centers, but once sites were approved for enrollment, there was no important difference in the number of participants enrolled. Limitations: The CombiRx trial was conducted during a period when multiple new medications were being tested, thus affecting the pace of recruitment and

Stanton's "The Solitude of Self": A Rationale for Feminism.

ERIC Educational Resources Information Center

Campbell, Karlyn Kohrs

1980-01-01

Examines Elizabeth Cady Stanton's speech, "The Solitude of Self," as a philosophical statement of the principles underlying the nineteenth century struggle for woman's rights in the United States. Analyzes the lyric structure and tone of the speech and its tragic, existential rationale for feminism. (JMF)

Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial

PubMed Central

2010-01-01

Background Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD) loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength) are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks. Methods/Design A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen), bone formation (osteocalcin), and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16) to explore the feasibility of modeling skeletal mechanical loads and

31 CFR 28.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Recruitment. 28.510 Section 28.510... Basis of Sex in Employment in Education Programs or Activities Prohibited § 28.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment...

36 CFR 1211.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Recruitment. 1211.310 Section... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 1211.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 1211.300 through 1211.310 apply shall not discriminate on the...

45 CFR 2555.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Recruitment. 2555.310 Section 2555.310 Public... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 2555.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 2555.300 through 2555.310 apply shall not discriminate on the...

10 CFR 5.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Recruitment. 5.510 Section 5.510 Energy NUCLEAR REGULATORY... Prohibited § 5.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has been found...

32 CFR 196.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 2 2010-07-01 2010-07-01 false Recruitment. 196.310 Section 196.310 National... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 196.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 196.300 through 196.310 apply shall not discriminate on the...

10 CFR 5.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Recruitment. 5.310 Section 5.310 Energy NUCLEAR REGULATORY... FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 5.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 5.300 through 5.310 apply shall not...

13 CFR 113.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Recruitment. 113.310 Section 113... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 113.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 113.300 through 113.310 apply shall not discriminate on the...

29 CFR 36.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Recruitment. 36.510 Section 36.510 Labor Office of the... Activities Prohibited § 36.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not discriminate on the basis of sex in the recruitment and hiring of employees. Where a recipient has...

45 CFR 83.12 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Recruitment. 83.12 Section 83.12 Public Welfare... § 83.12 Recruitment. (a) Comparable recruitment. A federally supported entity shall, with respect to... demonstrate that such action is part of a recruitment program which does not have the effect of discriminating...

18 CFR 1317.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Recruitment. 1317.310... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 1317.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 1317.300 through 1317.310 apply shall not discriminate on the...

45 CFR 618.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Recruitment. 618.310 Section 618.310 Public... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 618.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 618.300 through 618.310 apply shall not discriminate on the...

29 CFR 36.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Recruitment. 36.310 Section 36.310 Labor Office of the... FEDERAL FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 36.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 36.300 through 36.310...

38 CFR 23.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Recruitment. 23.310... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 23.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 23.300 through 23.310 apply shall not discriminate on the...

Data book: Space station/base food system study. Book 3: Study selection rationale sheets

NASA Technical Reports Server (NTRS)

1970-01-01

The supporting rationale sheets are presented which were utilized in the selection and support of the concepts considered in the final phase of the study. Each concept, conceived to fulfill a specific function of the food system, was assessed in terms of the eight critical factors depicted on the rationale sheet. When weighted and totaled, the resulting selection factor was used as a guide in making the final decision.

Research recruitment: A marketing framework to improve sample representativeness in health research.

PubMed

Howcutt, Sarah J; Barnett, Anna L; Barbosa-Boucas, Sofia; Smith, Lesley A

2018-04-01

This discussion paper proposes a five-part theoretical framework to inform recruitment strategies. The framework is based on a marketing model of consumer decision-making. Respondents in surveys are typically healthier than non-respondents, which has an impact on the availability of information about those most in need. Previous research has identified response patterns, provided theories about why people participate in research and evaluated different recruitment strategies. Social marketing has been applied successfully to recruitment and promotes focus on the needs of the participant, but little attention has been paid to the periods before and after participant-researcher contact (during advertising and following completion of studies). We propose a new model which conceptualises participation as a decision involving motivation, perception of information, attitude formation, integration of intention and action and finally evaluation and sharing of experience. Discussion paper. This discussion paper presents a critical review. No literature was excluded on date and the included citations span the years 1981-2017. The proposed framework suggests that researchers could engage a broader demographic if they shape research design and advertising to perform functions that participants are seeking to achieve. The framework provides a novel and useful conceptualisation of recruitment which could help to inform public engagement in research design, researcher training and research policy. This framework challenges researchers to investigate the goals of the potential participants when designing a study's advertising and procedures. © 2017 John Wiley & Sons Ltd.

Rationale and design of South Asian Birth Cohort (START): a Canada-India collaborative study.

PubMed

Anand, Sonia S; Vasudevan, Anil; Gupta, Milan; Morrison, Katherine; Kurpad, Anura; Teo, Koon K; Srinivasan, Krishnamachari

2013-01-28

People who originate from the Indian subcontinent (South Asians) suffer among the highest rates of type 2 diabetes in the world. Prior evidence suggests that metabolic risk factors develop early in life and are influenced by maternal and paternal behaviors, the intrauterine environment, and genetic factors. The South Asian Birth Cohort Study (START) will investigate the environmental and genetic basis of adiposity among 750 South Asian offspring recruited from highly divergent environments, namely, rural and urban India and urban Canada. Detailed information on health behaviors including diet and physical activity, and blood samples for metabolic parameters and DNA are collected from pregnant women of South Asian ancestry who are free of significant chronic disease. They also undergo a provocative test to diagnose impaired glucose tolerance and gestational diabetes. At delivery, cord blood and newborn anthropometric indices (i.e. birth weight, length, head circumference and skin fold thickness) are collected. The mother and growing offspring are followed prospectively and information on the growth trajectory, adiposity and health behaviors will be collected annually up to age 3 years. Our aim is to recruit a minimum of 750 mother-infant pairs equally divided between three divergent environments: rural India, urban India, and Canada. The START cohort will increase our understanding of the environmental and genetic determinants of adiposity and related metabolic abnormalities among South Asians living in India and Canada.

31 CFR 28.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Recruitment. 28.310 Section 28.310... Basis of Sex in Admission and Recruitment Prohibited § 28.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 28.300 through 28.310 apply shall not discriminate on the basis of sex in...

24 CFR 3.310 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Recruitment. 3.310 Section 3.310... Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 3.310 Recruitment. (a) Nondiscriminatory recruitment. A recipient to which §§ 3.300 through 3.310 apply shall not discriminate on the basis...

Women and Men Together in Recruit Training.

PubMed

Orme, Geoffrey J; Kehoe, E James

2018-05-01

male recruits, those in mixed-gender platoons had scores that were reliably lower than in all-male platoons, χ2 (4) = 48.38, p < 0.001; its effect size (V = 0.11) just exceeded the criterion for a small effect (0.10). Further analyses revealed that male scores had a near-zero correlation (r = -0.033) with the proportion of females in platoons (0-45%). This large-scale secondary analysis of instructor ratings of female and male recruits provides a platform for monitoring the integration of women into the combat arms. The analyses revealed nearly complete overlap in the performance of female versus male recruits. The detected gender-related differences were negligible to small in size. These small differences must be viewed with considerable caution. They may be artifacts of rater bias or other uncontrolled features of the rating system, which was designed for reporting individual recruit performance rather than aggregate analyses. Even with these limitations, this baseline snapshot of recruit performance suggests that, at recruit training, women and men are already working well together, which bodes well for their subsequent integration into the combat arms.

Simulating clinical trial visits yields patient insights into study design and recruitment.

PubMed

Lim, S Sam; Kivitz, Alan J; McKinnell, Doug; Pierson, M Edward; O'Brien, Faye S

2017-01-01

We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention. Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits. The Atlanta study involved 6 African-American patients (5 female) aged 27-60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32-75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1) information, communication, and education; 2) responsiveness to needs; 3) access to care; and 4) coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in discussing SLE, emphasis on transportation and child care help during the visits, and concerns related to financial matters; and they placed greater importance on time commitment, understanding of potential personal benefit, trust, and confidentiality of patient data as factors for participation. Using these results, we present recommendations to improve study procedures to increase retention, recruitment, and compliance

Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study.

PubMed

Thayabaranathan, Tharshanah; Cadilhac, Dominique A; Srikanth, Velandai K; Fitzgerald, Sharyn M; Evans, Roger G; Kim, Joosup; Gerraty, Richard P; Phan, Thanh G; Bladin, Christopher F; Nelson, Mark R; Frayne, Judith H; Thrift, Amanda G

2016-06-01

Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke. Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention. All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (n = 532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home. Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Advancing the science of recruitment and retention of ethnically diverse populations.

PubMed

Nápoles, Anna M; Chadiha, Letha A

2011-06-01

We highlight several critical challenges that must be addressed to accelerate the advancement of the science on recruitment and retention of ethnically diverse older adults into health research. These include the relative lack of attention by researchers to methodological issues related to recruitment and retention of ethnically diverse populations and the inadequacy of funding to advance systematically this field. We describe strategies used by the Resource Centers on Minority Aging Research and other National Institute of Aging-funded programs to advance the science of recruitment of ethnically diverse older adults. Finally, we propose a set of broad recommendations designed to generate a body of evidence on successful methods of recruitment and retention of ethnically diverse populations in health research. To eliminate health disparities and better understand aging processes in ethnically diverse populations, much more research is needed on effective strategies for increasing minority enrollment in health research. Comparative effectiveness research on more intensive recruitment and retention methods, which are often needed for including diverse populations, will require dedicated funding and concerted efforts by investigators.

A beginner's guide to writing the nursing conceptual model-based theoretical rationale.

PubMed

Gigliotti, Eileen; Manister, Nancy N

2012-10-01

Writing the theoretical rationale for a study can be a daunting prospect for novice researchers. Nursing's conceptual models provide excellent frameworks for placement of study variables, but moving from the very abstract concepts of the nursing model to the less abstract concepts of the study variables is difficult. Similar to the five-paragraph essay used by writing teachers to assist beginning writers to construct a logical thesis, the authors of this column present guidelines that beginners can follow to construct their theoretical rationale. This guide can be used with any nursing conceptual model but Neuman's model was chosen here as the exemplar.

Boomerang recruitment: bridging the gap.

PubMed

Hart, Karen A

2009-01-01

In today's competitive health care recruitment environment, one of the most cost-effective and successful recruitment strategies is alumni or "boomerang" recruitment. A proven business model, alumni recruitment is just beginning to be used in a significant way in the health care arena. The cost to recruit alumni is much lower than for those in the general workforce and the alumni population is a known quantity. Alumni will assimilate much more easily into your corporate culture, will need less orientation and onboarding, and will be more productive.

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: trial design, rationale and feasibility

PubMed Central

Reilly-Spong, Maryanne; Reibel, Diane; Pearson, Terry; Koppa, Pat; Gross, Cynthia R.

2015-01-01

Background Mindfulness-based stress reduction (MBSR) has demonstrated benefits for stress-related symptoms; however, for patients with burdensome treatment regimens, multiple co-morbidities and mobility impairment, time and travel requirements pose barriers to MBSR training. Purpose To describe the design, rationale and feasibility results of Journeys to Wellness, a clinical trial of mindfulness training delivered in a novel workshop and teleconference format. The trial aim is to reduce symptoms and improve quality of life in people waiting for a kidney transplant. Methods The standard 8-week MBSR program was reconfigured for delivery as two in-person workshops separated in time by six weekly teleconferences (tMBSR). A time and attention comparison condition (tSupport) was created using the workshop-telephone format. Feasibility results Kidney transplant candidates (N=63) were randomly assigned to tMBSR or tSupport: 87% (n=55) attended ≥1 class, and for these, attendance was high (6.6 ± 1.8 tMBSR and 7.0 ± 1.4 tSupport sessions). Fidelity monitoring found all treatment elements were delivered as planned and few technical problems occurred. Patients in both groups reported high treatment satisfaction, but more tMBSR (83%) than tSupport (43%) participants expected their intervention to be quite a bit or extremely useful for managing their health. Symptoms and quality of life outcomes collected before (baseline, 8 weeks and 6 months) and after kidney transplantation (2, 6 and 12 months) will be analyzed for efficacy. Conclusions tMBSR is an accessible intervention that may be useful to people with a wide spectrum of health conditions. Clinicaltrials.gov: NCT01254214 PMID:25847578

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches.

PubMed

Elliott, Daisy; Husbands, Samantha; Hamdy, Freddie C; Holmberg, Lars; Donovan, Jenny L

2017-11-01

The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups

Rationale for Incorporating Health and Safety into the Curriculum.

ERIC Educational Resources Information Center

Fleischman, Marvin

1988-01-01

Presents a philosophical commentary on the need and rationale for incorporating safety and health into the chemical engineering curriculum. Proposes safety and health assessments as useful teaching methods. Describes an approach to bringing safety and health into undergraduate engineering curricula. Gives examples of integration of these curricula…

Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis

PubMed Central

Treweek, Shaun; Lockhart, Pauline; Pitkethly, Marie; Cook, Jonathan A; Kjeldstrøm, Monica; Johansen, Marit; Taskila, Taina K; Sullivan, Frank M; Wilson, Sue; Jackson, Catherine; Jones, Ritu; Mitchell, Elizabeth D

2013-01-01

This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review. Objective To identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation. Design Systematic review. Data sources The Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied. Study selection Randomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility. Results 45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95

Using Google Adwords to recruit family carers of people with dementia.

PubMed

O'Dwyer, Siobhan T; Moyle, Wendy

2014-06-01

Online advertising is a new frontier in research recruitment and Google Adwords (GA) is one method of online advertising. Only a handful of studies, however, have described its cost and effectiveness and none have focused on older adults. The aim of this paper is to describe a GA campaign used to recruit family carers of people with dementia and provide insight for researchers planning to use GA to recruit other older adults. A GA campaign was used to recruit family carers of people with dementia to a cross-sectional study of wellbeing. The ads were viewed more than 450,000 times in a six-week period, but only 49 surveys were completed, at a cost of $122 per survey. GA has promise, but much remains to be understood about how to maximize its potential in ageing research. Recommendations for the design of future GA campaigns are provided. © 2013 ACOTA.

Next Steps in Primary Prevention of Coronary Heart Disease: Rationale for and Design of the ECAD Trial.

PubMed

Domanski, Michael J; Fuster, Valentin; Diaz-Mitoma, Francisco; Grundy, Scott; Lloyd-Jones, Donald; Mamdani, Muhammad; Roberts, Robin; Thorpe, Kevin; Hall, Judith; Udell, Jacob A; Farkouh, Michael E

2015-10-20

Atherosclerotic cardiovascular disease (ASCVD) events, including coronary heart disease and stroke, are the most frequent cause of death and major disability in the world. Current American College of Cardiology/American Heart Association primary prevention guidelines are mainly on the basis of randomized controlled trials of statin-based low-density lipoprotein cholesterol (LDL-C)-lowering therapy for primary prevention of ASCVD events. Despite the clear demonstration of statin-based LDL-C lowering, substantial 10-year and lifetime risks of incident ASCVD continue. Although the 10-year risk is low in young and middle-aged adults who would not be treated according to current guidelines, they ultimately account for most incident ASCVD. If statin-based LDL-C lowering were initiated in them at an age before complex coronary plaques are common in the population, a substantial reduction in lifetime risk of incident coronary heart disease might be achieved. We examine this hypothesis and introduce the design of a currently recruiting trial to address it. (Eliminate Coronary Artery Disease [ECAD]; NCT02245087). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results

PubMed Central

Li, Lingsheng; Blake, Caitlin; Sung, Yoon; Shpritz, Barnett; Chen, David; Genther, Dane J.; Betz, Joshua; Lin, Frank R.

2017-01-01

Hearing loss may affect critical domains of health and functioning in older adults. This article describes the rationale and design of the Studying Multiple Outcomes After Aural Rehabilitative Treatment (SMART) study, which was developed to determine to what extent current hearing rehabilitative therapies could mitigate the effects of hearing loss on health outcomes. One hundred and forty-five patients ≥50 years receiving hearing aids (HA) or cochlear implants (CI) were recruited from the Johns Hopkins Department of Otolaryngology-HNS. A standardized outcome battery was administered to assess cognitive, social, mental, and physical functioning. Of the 145 participants aged 50 to 94.9 years who completed baseline evaluations, CI participants had significantly greater loneliness, social isolation, and poorer hearing and communicative function compared with HA participants. This study showed that standardized measures of health-related outcomes commonly used in gerontology appear sensitive to hearing impairment and are feasible to implement in clinical studies of hearing loss. PMID:28491918

Computationally efficient models of neuromuscular recruitment and mechanics.

PubMed

Song, D; Raphael, G; Lan, N; Loeb, G E

2008-06-01

We have improved the stability and computational efficiency of a physiologically realistic, virtual muscle (VM 3.*) model (Cheng et al 2000 J. Neurosci. Methods 101 117-30) by a simpler structure of lumped fiber types and a novel recruitment algorithm. In the new version (VM 4.0), the mathematical equations are reformulated into state-space representation and structured into a CMEX S-function in SIMULINK. A continuous recruitment scheme approximates the discrete recruitment of slow and fast motor units under physiological conditions. This makes it possible to predict force output during smooth recruitment and derecruitment without having to simulate explicitly a large number of independently recruited units. We removed the intermediate state variable, effective length (Leff), which had been introduced to model the delayed length dependency of the activation-frequency relationship, but which had little effect and could introduce instability under physiological conditions of use. Both of these changes greatly reduce the number of state variables with little loss of accuracy compared to the original VM. The performance of VM 4.0 was validated by comparison with VM 3.1.5 for both single-muscle force production and a multi-joint task. The improved VM 4.0 model is more suitable for the analysis of neural control of movements and for design of prosthetic systems to restore lost or impaired motor functions. VM 4.0 is available via the internet and includes options to use the original VM model, which remains useful for detailed simulations of single motor unit behavior.

Computationally efficient models of neuromuscular recruitment and mechanics

NASA Astrophysics Data System (ADS)

Song, D.; Raphael, G.; Lan, N.; Loeb, G. E.

2008-06-01

We have improved the stability and computational efficiency of a physiologically realistic, virtual muscle (VM 3.*) model (Cheng et al 2000 J. Neurosci. Methods 101 117-30) by a simpler structure of lumped fiber types and a novel recruitment algorithm. In the new version (VM 4.0), the mathematical equations are reformulated into state-space representation and structured into a CMEX S-function in SIMULINK. A continuous recruitment scheme approximates the discrete recruitment of slow and fast motor units under physiological conditions. This makes it possible to predict force output during smooth recruitment and derecruitment without having to simulate explicitly a large number of independently recruited units. We removed the intermediate state variable, effective length (Leff), which had been introduced to model the delayed length dependency of the activation-frequency relationship, but which had little effect and could introduce instability under physiological conditions of use. Both of these changes greatly reduce the number of state variables with little loss of accuracy compared to the original VM. The performance of VM 4.0 was validated by comparison with VM 3.1.5 for both single-muscle force production and a multi-joint task. The improved VM 4.0 model is more suitable for the analysis of neural control of movements and for design of prosthetic systems to restore lost or impaired motor functions. VM 4.0 is available via the internet and includes options to use the original VM model, which remains useful for detailed simulations of single motor unit behavior.

Talent Search: Purposes, Rationale, and Role in Gifted Education.

ERIC Educational Resources Information Center

Olszewski-Kubilius, Paula

1998-01-01

This paper describes the purpose and rationale of a "talent search" effort to identify gifted students through use of off-level testing. Three components are stressed: diagnosis and evaluation of domains and levels of talent; educational placement and guidance; and talent development opportunities. Research supporting the talent-search…

Recruitment dynamics in adaptive social networks

NASA Astrophysics Data System (ADS)

Shkarayev, Maxim; Shaw, Leah; Schwartz, Ira

2011-03-01

We model recruitment in social networks in the presence of birth and death processes. The recruitment is characterized by nodes changing their status to that of the recruiting class as a result of contact with recruiting nodes. The recruiting nodes may adapt their connections in order to improve recruitment capabilities, thus changing the network structure. We develop a mean-field theory describing the system dynamics. Using mean-field theory we characterize the dependence of the growth threshold of the recruiting class on the adaptation parameter. Furthermore, we investigate the effect of adaptation on the recruitment dynamics, as well as on network topology. The theoretical predictions are confirmed by the direct simulations of the full system.

The Coordination and Activity Tracking in CHildren (CATCH) study: rationale and design.

PubMed

Cairney, John; Missiuna, Cheryl; Timmons, Brian W; Rodriguez, Christine; Veldhuizen, Scott; King-Dowling, Sara; Wellman, Sarah; Le, Tuyen

2015-12-21

Past studies have found that children with Developmental Coordination Disorder (DCD) engage in less physical activity than typically developing children. This "activity deficit" may result in children with DCD being less physically fit and more likely to be overweight or obese, potentially increasing later risk for poor cardiovascular health. Unfortunately, the majority of DCD research has been limited to cross-sectional designs, leading to questions about the complex relationship among motor ability, inactivity and health-related fitness. Of the few longitudinal studies on the topic, determining precedence amongst these factors is difficult because study cohorts typically focus on mid to late childhood. By this age, both decreased physical fitness and obesity are often established. The Coordination and Activity Tracking in CHildren (CATCH) study will examine the pathways connecting DCD, physical activity, physical fitness, and body composition from early to middle childhood. The CATCH study is a prospective cohort study. We aim to recruit a cohort of 600 children aged 4 to 5 years (300 probable DCD [pDCD] and 300 controls) and test them once a year for 4 years. At Phase 1 of baseline testing, we assess motor skills, cognitive ability (IQ), basic anthropometry, flexibility and lower body muscle strength, while parents complete an interview and questionnaires regarding family demographics, their child's physical activity, and behavioural characteristics. Children who move on to Phase 2 (longitudinal cohort) have their body fat percentage, foot structure, aerobic and anaerobic fitness assessed. An accelerometer to measure physical activity is then given to the child and interested family members. The family also receives an accelerometer logbook and 3-day food dairy. At years 2 to 4, children in the longitudinal cohort will have all baseline assessments repeated (excluding the IQ test), and complete an additional measure of perceived self-efficacy. Parents will

Treating alcoholism through a narrative approach. Case study and rationale.

PubMed Central

Kaminsky, D.; Rabinowitz, S.; Kasan, R.

1996-01-01

A case study illustrates the narrative or story-telling approach to treating alcoholism. We discuss the rationale for this method and describe how it could be useful in family practice for treating people with alcohol problems. PMID:8653035

The Minority Recruitment Program at the Pennsylvania College of Optometry.

ERIC Educational Resources Information Center

Cohen, Karen

1987-01-01

A program to recruit and retain minority group optometry students is described, including the program's design, student financial aid, a preenrollment enrichment program to ease the adjustment to professional school, and the personal and academic program outcomes. (MSE)

Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study

PubMed Central

2012-01-01

Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. Methods/Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy. A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I), 9 months of continued monthly contact (Phase II) and then 6 months

A randomised study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery; rationale and design of DECREASE-XIII.

PubMed

Bakker, E J; Ravensbergen, N J; Voute, M T; Hoeks, S E; Chonchol, M; Klimek, M; Poldermans, D

2011-09-01

This article describes the rationale and design of the DECREASE-XIII trial, which aims to evaluate the potential of esmolol infusion, an ultra-short-acting beta-blocker, during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery. A double-blind, placebo-controlled, randomised trial. A total of 260 vascular surgery patients will be randomised to esmolol or placebo as an add-on to standard medical care, including chronic low-dose beta-blockers. Esmolol is titrated to maintain a heart rate within a target window of 60-80 beats per minute for 24 h from the induction of anaesthesia. Heart rate and ischaemia are assessed by continuous 12-lead electrocardiographic monitoring for 72 h, starting 1 day prior to surgery. The primary outcome measure is duration of heart rate outside the target window during infusion of the study drug. Secondary outcome measures will be the efficacy parameters of occurrence of cardiac ischaemia, troponin T release, myocardial infarction and cardiac death within 30 days after surgery and safety parameters such as the occurrence of stroke and hypotension. This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters. Copyright © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Recruitment strategies should not be randomly selected: empirically improving recruitment success and diversity in developmental psychology research

PubMed Central

Sugden, Nicole A.; Moulson, Margaret C.

2015-01-01

Psychological and developmental research have been critiqued for the lack of diversity of research samples. Because differences in culture, race, and ethnicity can influence participant behavior, limited diversity limits the generalizability of the findings. These differences may also impact how participants behave in response to recruitment attempts, which suggests that recruitment itself may be leveraged to increase sample diversity. The goal of the current study was to determine what factors, within a recruitment interaction, could be leveraged to increase success and diversity when recruiting families with children for developmental research. Study 1 found three factors influenced success: (1) recruitment was more successful when other potential participants were also interested (i.e., recruiters were busy), (2) recruiters of particular races were more successful than recruiters of other races, and (3) differences in success were related to what the recruiter said to engage the potential participant (i.e., the script). The latter two factors interacted, suggesting some recruiters were using less optimal scripts. To improve success rates, study 2 randomly assigned scripts to recruiters and encouraged them to recruit more vigorously during busy periods. Study 2 found that two factors influenced success: (1) some scripts were more successful than others and (2) we were more successful at recruiting non-White potential participants than White participants. These two interacted, with some scripts being more successful with White and other scripts being more successful with non-White families. This intervention significantly increased recruitment success rate by 8.1% and the overall number of families recruited by 15.3%. These findings reveal that empirically evaluating and tailoring recruitment efforts based on the most successful strategies is effective in boosting diversity through increased participation of children from non-White families. PMID:25972829

Recruiting from within: Action-Oriented Research Solutions to Internal Student Recruitment in Collegiate Aviation Education.

ERIC Educational Resources Information Center

Bowen, Brent; Carstenson, Larry; Hansen, Frederick

1999-01-01

Discusses student recruitment in aviation education and establishes that internal recruitment methods are the most productive and cost effective. Provides examples of recruitment strategies based on a model of action research. (JOW)

Rationale and design of South Asian Birth Cohort (START): a Canada-India collaborative study

PubMed Central

2013-01-01

Background People who originate from the Indian subcontinent (South Asians) suffer among the highest rates of type 2 diabetes in the world. Prior evidence suggests that metabolic risk factors develop early in life and are influenced by maternal and paternal behaviors, the intrauterine environment, and genetic factors. The South Asian Birth Cohort Study (START) will investigate the environmental and genetic basis of adiposity among 750 South Asian offspring recruited from highly divergent environments, namely, rural and urban India and urban Canada. Methods Detailed information on health behaviors including diet and physical activity, and blood samples for metabolic parameters and DNA are collected from pregnant women of South Asian ancestry who are free of significant chronic disease. They also undergo a provocative test to diagnose impaired glucose tolerance and gestational diabetes. At delivery, cord blood and newborn anthropometric indices (i.e. birth weight, length, head circumference and skin fold thickness) are collected. The mother and growing offspring are followed prospectively and information on the growth trajectory, adiposity and health behaviors will be collected annually up to age 3 years. Our aim is to recruit a minimum of 750 mother-infant pairs equally divided between three divergent environments: rural India, urban India, and Canada. Summary The START cohort will increase our understanding of the environmental and genetic determinants of adiposity and related metabolic abnormalities among South Asians living in India and Canada. PMID:23356884

Recruitment dynamics in adaptive social networks

NASA Astrophysics Data System (ADS)

Shkarayev, Maxim S.; Schwartz, Ira B.; Shaw, Leah B.

2013-06-01

We model recruitment in adaptive social networks in the presence of birth and death processes. Recruitment is characterized by nodes changing their status to that of the recruiting class as a result of contact with recruiting nodes. Only a susceptible subset of nodes can be recruited. The recruiting individuals may adapt their connections in order to improve recruitment capabilities, thus changing the network structure adaptively. We derive a mean-field theory to predict the dependence of the growth threshold of the recruiting class on the adaptation parameter. Furthermore, we investigate the effect of adaptation on the recruitment level, as well as on network topology. The theoretical predictions are compared with direct simulations of the full system. We identify two parameter regimes with qualitatively different bifurcation diagrams depending on whether nodes become susceptible frequently (multiple times in their lifetime) or rarely (much less than once per lifetime).

Recruitment dynamics in adaptive social networks.

PubMed

Shkarayev, Maxim S; Schwartz, Ira B; Shaw, Leah B

2013-01-01

We model recruitment in adaptive social networks in the presence of birth and death processes. Recruitment is characterized by nodes changing their status to that of the recruiting class as a result of contact with recruiting nodes. Only a susceptible subset of nodes can be recruited. The recruiting individuals may adapt their connections in order to improve recruitment capabilities, thus changing the network structure adaptively. We derive a mean field theory to predict the dependence of the growth threshold of the recruiting class on the adaptation parameter. Furthermore, we investigate the effect of adaptation on the recruitment level, as well as on network topology. The theoretical predictions are compared with direct simulations of the full system. We identify two parameter regimes with qualitatively different bifurcation diagrams depending on whether nodes become susceptible frequently (multiple times in their lifetime) or rarely (much less than once per lifetime).

The effects of two different incentives on recruitment rates of families into a prevention program.

PubMed

Heinrichs, Nina

2006-07-01

This study experimentally manipulated two incentives for participation (monetary: paid participation for sessions and setting: group vs. individual) in a child behavior problem prevention program to analyze their effects on recruitment and retention of families. A population of 690 eligible families from 15 preschools located in socially disadvantaged neighborhoods was invited to participate in a parent training (PT) program. The study recruited parents by using advertisements that had information describing only the indicated condition (i.e., PT in group-unpaid, or PT individual-unpaid, or PT in group-paid, or PT individual-paid). Results demonstrate significant impact of payment on recruitment and initial attendance. Training setting alone (individual or group) did not significantly influence these rates. Editors' Strategic Implications: A compelling case is made for the utility of monetary incentives to increase proportions of low-income families in prevention research and programs. Evaluators and program designers should note the impressive use of the experimental design and hierarchical linear modeling to test the effects on recruitment.

Recruiting patients as partners in health research: a qualitative descriptive study.

PubMed

Vat, Lidewij Eva; Ryan, Devonne; Etchegary, Holly

2017-01-01

Increasingly, funders and researchers want to partner with patients in health research, but it can be challenging for researchers to find patient partners. More than taking part in research as participants, patient partners help design, carry out and manage research projects. The goal of this study was to describe ways that patient partners have been recruited by researchers and patient engagement leads (individuals within organizations responsible for promoting and supporting patients as research partners). We talked with researchers and patient engagement leads in Canada and the United Kingdom, as well as a patient representative. We found three ways that could help researchers and patients find each other. One way is a case-by-case basis, where patients are often sought with experience of a health condition that is the focus of the research. The other ways involved directories where projects were posted and could be found by patients and researchers, or a third party matched patients with research projects. We found four recruitment strategies:Social marketingCommunity outreachHealth systemPartnering with other organizations (e.g., advocacy groups) There are many influences on finding, selecting and retaining patient partners: patient characteristics, the local setting, the opportunity, work climate, education and support. We hope study results will provide a useful starting point for research teams in recruiting their patient partners. Background Patient engagement in clinical trials and other health research continues to gain momentum. While the benefits of patient engagement in research are emerging, relatively little is known about recruiting patients as research partners. The purpose of this study was to describe recruitment strategies and models of recruiting patients as partners in health research. Methods Qualitative descriptive study. Thirteen patient engagement leads and health researchers from Canada and the United Kingdom, as well as one patient

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

Recruiting U.S. Chinese Elders into Clinical Research for Dementia

PubMed Central

Li, Clara; Neugroschl, Judith; Umpierre, Mari; Martin, Jane; Huang, QiYing; Zeng, Xiaoyi; Cai, Dongming; Sano, Mary

2016-01-01

Purpose This study described and evaluated the rapid recruitment of elderly Chinese into clinical research at the Mount Sinai Alzheimer’s Disease Research Center (MSADRC). Design and Methods Methods of publicizing the study included lectures to local senior centers/churches and publications in local Chinese newspapers. The amount of time and success of these methods were evaluated. A “go to them” model of evaluation was employed to enable participants to complete the study visit at locations where they were comfortable. Results From January to December 2015, we recruited 98 participants aged ≥ 65 who primarily speak Mandarin/Cantonese and reside in New York. The mean age and years of education was 73.93±6.34 and 12.79±4.58, respectively. The majority of participants were female (65.3%) and primarily Mandarin speaking (53.1%). Of all enrollees, 54.1% were recruited from community lectures, 29.6% through newspapers, 10.2% through word of mouth, and 6.1% from our clinical services. 40.8% of participants underwent evaluations at the MSADRC, 44.9% at local senior centers/churches, and 14.3% at home. Implications Given that the majority of our participants had low English proficiency, the use of bilingual recruiters probably allowed us to overcome the language barrier, facilitating recruitment. Our “go to them” model of evaluation is another important factor contributing to our successful recruitment. PMID:27819841

Rethinking Recruitment: The Comprehensive and Strategic Recruitment of Secondary Science Teachers

ERIC Educational Resources Information Center

Luft, Julie A.; Wong, Sissy S.; Semken, Steve

2011-01-01

The shortage of science teachers has spurred a discussion about their retention and recruitment. While discussion about retaining science teachers has increased dramatically in just the last few years, science teacher educators have not attended to the recruitment of science teachers with the same tenacity. This paper is our effort to initiate…

Rationale and Design of the Randomized Evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study

PubMed Central

Coburn, Brian W; Cheetham, T Craig; Rashid, Nazia; Chang, John M; Levy, Gerald D; Kerimian, Artak; Low, Kimberly J; Redden, David T; Bridges, S Louis; Saag, Kenneth G; Curtis, Jeffrey R; Mikuls, Ted R

2016-01-01

Background Despite the availability of effective therapies, most gout patients achieve suboptimal treatment outcomes. Current best practices suggest gradual dose-escalation of urate lowering therapy and serial serum urate (sUA) measurement to achieve sUA < 6.0 mg/dl. However, this strategy is not routinely used. Here we present the study design rationale and development for a pharmacist-led intervention to promote sUA goal attainment. Methods To overcome barriers in achieving optimal outcomes, we planned and implemented the Randomized Evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) study. This is a large pragmatic cluster-randomized trial designed to assess a highly automated, pharmacist-led intervention to optimize allopurinol treatment in gout. Ambulatory clinics (n=101) from a large health system were randomized to deliver either the pharmacist-led intervention or usual care to gout patients over the age of 18 years newly initiating allopurinol. All participants received educational materials and could opt-out of the study. For intervention sites, pharmacists conducted outreach primarily via an automated telephone interactive voice recognition system. The outreach, guided by a gout care algorithm developed for this study, systematically promoted adherence assessment, facilitated sUA testing, provided education, and adjusted allopurinol dosing. The primary study outcomes are achievement of sUA < 6.0 mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently. Conclusion Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients. PMID:27449546

Rationale and design of the randomized evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) Study.

PubMed

Coburn, Brian W; Cheetham, T Craig; Rashid, Nazia; Chang, John M; Levy, Gerald D; Kerimian, Artak; Low, Kimberly J; Redden, David T; Bridges, S Louis; Saag, Kenneth G; Curtis, Jeffrey R; Mikuls, Ted R

2016-09-01

Despite the availability of effective therapies, most gout patients achieve suboptimal treatment outcomes. Current best practices suggest gradual dose-escalation of urate lowering therapy and serial serum urate (sUA) measurement to achieve sUA<6.0mg/dl. However, this strategy is not routinely used. Here we present the study design rationale and development for a pharmacist-led intervention to promote sUA goal attainment. To overcome barriers in achieving optimal outcomes, we planned and implemented the Randomized Evaluation of an Ambulatory Care Pharmacist-Led Intervention to Optimize Urate Lowering Pathways (RAmP-UP) study. This is a large pragmatic cluster-randomized trial designed to assess a highly automated, pharmacist-led intervention to optimize allopurinol treatment in gout. Ambulatory clinics (n=101) from a large health system were randomized to deliver either the pharmacist-led intervention or usual care to gout patients over the age of 18years newly initiating allopurinol. All participants received educational materials and could opt-out of the study. For intervention sites, pharmacists conducted outreach primarily via an automated telephone interactive voice recognition system. The outreach, guided by a gout care algorithm developed for this study, systematically promoted adherence assessment, facilitated sUA testing, provided education, and adjusted allopurinol dosing. The primary study outcomes are achievement of sUA<6.0mg/dl and treatment adherence determined after one year. With follow-up ongoing, study results will be reported subsequently. Ambulatory care pharmacists and automated calling technology represent potentially important, underutilized resources for improving health outcomes for gout patients. Copyright © 2016 Elsevier Inc. All rights reserved.

The Effects of Rationales, Differential Reinforcement, and a Guided Compliance Procedure to Increase Compliance among Preschool Children

ERIC Educational Resources Information Center

Wilder, David A.; Myers, Kristin; Nicholson, Katie; Allison, Janelle; Fischetti, Anthony T.

2012-01-01

Previous research suggests that rationales, or statements describing why a child should comply with a caregiver-delivered instruction, are ineffective at increasing compliance. In the current study, we compared the effects of rationales to a differential reinforcement procedure and a guided compliance procedure. The results indicated that…

Recruitment of obese black women into a physical activity and nutrition intervention trial.

PubMed

Sharp, Lisa K; Fitzgibbon, Marian L; Schiffer, Linda

2008-11-01

Despite the increased health risks for obese Black women, relatively little research has explored physical activity and nutrition interventions for these women. This article describes the recruitment strategies used in a program designed specifically for obese Black women. Recruitment of Black women age 30 to 65 years with body mass indices between 30 kg/m2and 50 kg/m2was completed using in-person recruitment and flyers within 2 miles of the intervention site along with mass e-mails within the sponsoring university system. Medical clearance from a physician was an eligibility requirement because of Institutional Review Board safety concerns. Of the 690 women who were screened, 213 (31%) were eligible and randomized. The most common reason for exclusion was failure to return a medical clearance form (n = 167, 39% of ineligible). Different rates of efficiency were noted across recruitment approaches. Black women were successfully recruited using in-person community recruitment, e-mail, and community flyers within close proximity to the intervention site. Careful consideration should be given to the advantages and disadvantages of various recruitment strategies that might not generalize across studies.

Rare lung disease research: strategies for improving identification and recruitment of research participants.

PubMed

Gupta, Samir; Bayoumi, Ahmed M; Faughnan, Marie E

2011-11-01

Research in rare lung diseases faces methodologic limitations by virtue of the small number of participants available to be studied. We explored several strategies that may improve researchers' ability to identify and recruit research participants with rare lung diseases. We provide an overview of strategies based on available evidence, previously used approaches, and reasoning. First, disease detection is generally poor and may be improved through strategies targeted at primary care practitioners or directly at patients, thus increasing the pool of patients available for research studies. Next, standardization of case definitions in rare lung diseases is often lacking, hindering research recruitment efforts because of confusion over appropriate recruitment criteria. Expert consensus statements can enhance both clinical care and research recruitment by standardizing definitions. Finally, recruitment strategies using rare lung disease registries, clinical research networks, novel Internet-based direct patient recruitment approaches, and patient organizations may facilitate recruitment of patients with rare lung diseases. In summary, although several strategies for improving the identification and recruitment of research participants with rare lung diseases have been proposed, published examples are few. Objective measurement and reporting of novel recruitment methods and collaboration among researchers facing the same limitations across various rare lung diseases are required. Advancements in this area are vital to the design and performance of much-needed robust clinical studies across the spectrum of rare lung diseases.

A Psychological Rationale for Adventure Therapy with Hospitalized Adolescents.

ERIC Educational Resources Information Center

Gillis, H. L.; And Others

The purpose of this study was to examine the Wechsler Intelligence Scale for Children-Revised (WISC-R) profiles of two treatment populations and present a theoretical rationale for using adventure therapy. Data for the first group were obtained from the psychological testing records of 150 randomly selected inpatients (81 males, 69 females)…

Throwing Caution to the Wind: Rationales for Risky Behavior.

ERIC Educational Resources Information Center

de La Rue, Denise; Ruback, R. Barry

There appears to be a tendency for people who have not been victimized by negative life events to perceive themselves as less vulnerable to victimization than others. Research has revealed this unrealistic optimism in risk perception. A study on rationales for risky behaviors was conducted to identify reasons other than this illusion of…

Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia.

PubMed

Lee, Jeannette Y; Foster, Harris E; McVary, Kevin T; Meleth, Sreelatha; Stavris, Karen; Downey, Joe; Kusek, John W

2011-05-01

The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy. CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS. The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS. The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms. Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated study population.

Beyond traditional advertisements: leveraging Facebook's social structures for research recruitment.

PubMed

Valdez, Rupa S; Guterbock, Thomas M; Thompson, Morgan J; Reilly, Jeremiah D; Menefee, Hannah K; Bennici, Maria S; Williams, Ishan C; Rexrode, Deborah L

2014-10-27

Obtaining access to a demographically and geographically diverse sample for health-related research can be costly and time consuming. Previous studies have reported mixed results regarding the potential of using social media-based advertisements to overcome these challenges. Our aim was to develop and assess the feasibility, benefits, and challenges of recruiting for research studies related to consumer health information technology (IT) by leveraging the social structures embedded in the social networking platform, Facebook. Two recruitment strategies that involved direct communication with existing Facebook groups and pages were developed and implemented in two distinct populations. The first recruitment strategy involved posting a survey link directly to consenting groups and pages and was used to recruit Filipino-Americans to a study assessing the perceptions, use of, and preferences for consumer health IT. This study took place between August and December 2013. The second recruitment strategy targeted individuals with type 2 diabetes and involved creating a study-related Facebook group and asking administrators of other groups and pages to publicize our group to their members. Group members were then directly invited to participate in an online pre-study survey. This portion of a larger study to understand existing health management practices as a foundation for consumer health IT design took place between May and June 2014. In executing both recruitment strategies, efforts were made to establish trust and transparency. Recruitment rate, cost, content of interaction, and characteristics of the sample obtained were used to assess the recruitment methods. The two recruitment methods yielded 87 and 79 complete responses, respectively. The first recruitment method yielded a rate of study completion proportionate to that of the rate of posts made, whereas recruitment successes of the second recruitment method seemed to follow directly from the actions of a subset

The Conceptual Design of the Magdalena Ridge Observatory Interferometer

NASA Astrophysics Data System (ADS)

Buscher, D. F.; Creech-Eakman, M.; Farris, A.; Haniff, C. A.; Young, J. S.

We describe the scientific motivation for and conceptual design of the Magdalena Ridge Observatory Interferometer, an imaging interferometer designed to operate at visible and near-infrared wavelengths. The rationale for the major technical decisions in the interferometer design is discussed, the success of the concept is appraised, and the implications of this analysis for the design of future arrays are drawn out.

44 CFR 19.510 - Recruitment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Recruitment. 19.510 Section 19.510 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF... Programs or Activities Prohibited § 19.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A...

From COPD epidemiology to studies of pathophysiological disease mechanisms: challenges with regard to study design and recruitment process: Respiratory and Cardiovascular Effects in COPD (KOLIN).

PubMed

Lindberg, Anne; Linder, Robert; Backman, Helena; Eriksson Ström, Jonas; Frølich, Andreas; Nilsson, Ulf; Rönmark, Eva; Johansson Strandkvist, Viktor; Behndig, Annelie F; Blomberg, Anders

2017-01-01

Background : Chronic obstructive pulmonary disease (COPD) is a largely underdiagnosed disease including several phenotypes. In this report, the design of a study intending to evaluate the pathophysiological mechanism in COPD in relation to the specific phenotypes non-rapid and rapid decline in lung function is described together with the recruitment process of the study population derived from a population based study. Method : The OLIN COPD study includes a population-based COPD cohort and referents without COPD identified in 2002-04 ( n  = 1986), and thereafter followed annually since 2005. Lung function decline was estimated from baseline in 2002-2004 to 2010 (first recruitment phase) or to 2012/2013 (second recruitment phase). Individuals who met the predefined criteria for the following four groups were identified; group A) COPD grade 2-3 with rapid decline in FEV 1 and group B) COPD grade 2-3 without rapid decline in FEV 1 (≥60 and ≤30 ml/year, respectively), group C) ever-smokers, and group D) non-smokers with normal lung function. Groups A-C included ever-smokers with >10 pack years. The intention was to recruit 15 subjects in each of the groups A-D. Results : From the database groups A-D were identified; group A n  = 37, group B n  = 29, group C n  = 41, and group D n  = 55. Fifteen subjects were recruited from groups C and D, while this goal was not reached in the groups A ( n  = 12) and B ( n  = 10). The most common reasons for excluding individuals identified as A or B were comorbidities contraindicating bronchoscopy, or inflammatory diseases/immune suppressive medication expected to affect the outcome. Conclusion : The study is expected to generate important results regarding pathophysiological mechanisms associated with rate of decline in lung function among subjects with COPD and the in-detail described recruitment process, including reasons for non-participation, is a strength when interpreting the results in forthcoming studies.

Effects of Interdisciplinary Education on Technology-Driven Application Design

ERIC Educational Resources Information Center

Tafa, Z.; Rakocevic, G.; Mihailovic, D.; Milutinovic, V.

2011-01-01

This paper describes the structure and the underlying rationale of a new course dedicated to capability maturity model integration (CMMI)-directed design of wireless sensor networks (WSNs)-based biomedical applications that stresses: 1) engineering-, medico-engineering-, and informatics-related issues; 2) design for general- and special-purpose…

Application of plantar pressure assessment in footwear and insert design.

PubMed

Mueller, M J

1999-12-01

This clinical perspective describes the application of plantar pressure assessment in footwear and insert design. First, the rationale and evidence for using pressure assessment to assist in the design of footwear for patients with diabetes is described. I discuss 2 important measures obtained from pressure assessment: peak pressure, because it represents the magnitude of potential mechanical stresses that can contribute to skin breakdown, and contact area, because this identifies the treatment areas. Using measures obtained from pressure assessment, guidelines are presented to maximize contact area of the insert to the foot and reduce highest peak pressures on the skin, with the goal of preventing skin breakdown. Second, a rationale and guidelines are presented for the application of plantar pressure assessment in the evaluation and design of footwear for people without impairments (i.e., the general public). Finally, future applications of pressure assessment to improve the design and fit of shoes are discussed. Benefits and limitations of using pressure assessment to assist in footwear design are addressed throughout.

Recruitment of black women with type 2 diabetes into a self-management intervention trial.

PubMed

Newlin, Kelley; Melkus, Gail D'Eramo; Jefferson, Vanessa; Langerman, Susan; Womack, Julie; Chyun, Deborah

2006-01-01

The purpose of this study was to evaluate the relationship of recruitment methods to enrollment status in Black women with type 2 diabetes screened for entry into a randomized clinical trial (RCT). Using a cross-sectional study design with convenience sampling procedures, data were collected on recruitment methods to which the women responded (N=236). Results demonstrated that the RCT had a moderate overall recruitment rate of 46% and achieved only 84% of its projected accrual goal (N=109). Chi-square analysis demonstrated that enrollment outcomes varied significantly according to recruitment methods (P=.05). Recruitment methods such as community health fairs (77.8%), private practice referrals (75.0%), participant referrals (61.5%), community clinic referrals (44.6%), community advertising and marketing (40.9%), and chart review (40.4%) demonstrated variable enrollment yields. Results confirm previous findings that indicate that Black Americans may be successfully recruited into research studies at moderate rates when traditional recruitment methods are enhanced and integrated with more culturally sensitive methods. Lessons learned are considered.

44 CFR 19.510 - Recruitment.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Recruitment. 19.510 Section 19.510 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND... Activities Prohibited § 19.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall...

10 CFR 1042.510 - Recruitment.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Recruitment. 1042.510 Section 1042.510 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR... Education Programs or Activities Prohibited § 1042.510 Recruitment. (a) Nondiscriminatory recruitment and...

28 CFR 345.31 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Recruitment. 345.31 Section 345.31 Judicial Administration FEDERAL PRISON INDUSTRIES, INC., DEPARTMENT OF JUSTICE FEDERAL PRISON INDUSTRIES (FPI) INMATE WORK PROGRAMS Recruitment and Hiring Practices § 345.31 Recruitment. Inmate workers for...

The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods.

PubMed

Williamson, Jeff D; Miller, Michael E; Bryan, R Nick; Lazar, Ronald M; Coker, Laura H; Johnson, Janice; Cukierman, Tali; Horowitz, Karen R; Murray, Anne; Launer, Lenore J

2007-06-18

Type 2 diabetes mellitus and cognitive impairment are 2 of the most common chronic conditions found in persons aged > or = 60 years. Clinical studies have shown a greater prevalence of global cognitive impairment, incidence of cognitive decline, and incidence of Alzheimer disease in patients with type 2 diabetes. To date, there have been no randomized trials of the effects of long-term glycemic control on cognitive function and structural brain changes in patients with type 2 diabetes. The primary aim of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Memory in Diabetes Study (ACCORD-MIND) is to test whether there is a difference in the rate of cognitive decline and structural brain change in patients with diabetes treated with standard-care guidelines compared with those treated with intensive-care guidelines. This comparison will be made in a subsample of 2,977 patients with diabetes participating in the ongoing ACCORD trial, a clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI) with support from the National Institute on Aging (NIA). Data from this ACCORD substudy on the possible beneficial or adverse effects of intensive treatment on cognitive function will be obtained from a 30-minute test battery, administered at baseline and 20-month and 40-month visits. In addition, full-brain magnetic resonance imaging will be performed on 630 participants at baseline and at 40 months to assess the relation between the ACCORD treatments and structural brain changes. The general aim of ACCORD-MIND is to determine whether the intensive treatment of diabetes, a major risk factor for Alzheimer disease and vascular dementia, can reduce the early decline in cognitive function that could later evolve into more cognitively disabling conditions. This report presents the design, rationale, and methods of the ACCORD-MIND substudy.

On Recruiting: A Multivariate Analysis of Marine Corps Recruiters and the Market

DTIC Science & Technology

Three recommendations result from this study. The quantitative recommendation developed in this thesis is to add approximately three missioned...canvassing recruiters per Recruiting Station, or 144 total, where the marginal cost of the 1,400 potentially gained contracts is the most economical manpower

International Student Recruitment: Trends and Challenges

ERIC Educational Resources Information Center

Falcone, Santa

2017-01-01

This paper provides a review of current trends in international student recruitment. Focusing specifically on recruitment of Chinese students, important aspects of China's educational system relevant to recruitment are presented. Barriers to Chinese student recruitment are then discussed. Successful, employed, international graduates validate…

Developing a Language Learning Rationale for African Language Tutorials.

ERIC Educational Resources Information Center

Dwyer, David

1999-01-01

Presents a rationale for the supervised tutorial component of the African language program at Michigan State University. The supervised tutorial is one of two modes through which African languages are offered at Michigan State University. The other, which is teacher led, is offered for high enrollment languages such as Arabic, Swahili, and Hausa.…

Introducing ICT in Schools in England: Rationale and Consequences

ERIC Educational Resources Information Center

Hammond, Michael

2014-01-01

This paper provides a critical perspective on the attempts to promote the use of information and communication technology (ICT) in teaching and learning in England. It describes the rationale given for the introduction of ICT in terms of its potential to impact on educational standards to contribute to developing a curriculum which has more…

Preparing Alumni for Student Recruitment.

ERIC Educational Resources Information Center

Mount, Brian

As recruitment budgets continue to tighten and with fewer colleges reporting application increases for their freshmen classes, enrollment managers must continue to explore all potential sources of recruitment talent. Alumni are often an underutilized or sometimes poorly utilized resource in recruitment efforts. Younger alumni, for example, may…

45 CFR 618.310 - Recruitment.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Discrimination on the Basis of Sex in Admission and Recruitment Prohibited § 618.310 Recruitment. (a... basis of sex in the recruitment and admission of students. A recipient may be required to undertake...

22 CFR 146.510 - Recruitment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Recruitment. 146.510 Section 146.510 Foreign Relations DEPARTMENT OF STATE CIVIL RIGHTS NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR... Education Programs or Activities Prohibited § 146.510 Recruitment. (a) Nondiscriminatory recruitment and...

22 CFR 146.510 - Recruitment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Recruitment. 146.510 Section 146.510 Foreign Relations DEPARTMENT OF STATE CIVIL RIGHTS NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR... Education Programs or Activities Prohibited § 146.510 Recruitment. (a) Nondiscriminatory recruitment and...

10 CFR 5.510 - Recruitment.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Recruitment. 5.510 Section 5.510 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Prohibited § 5.510 Recruitment. (a) Nondiscriminatory recruitment and hiring. A recipient shall not...

49 CFR 25.510 - Recruitment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false Recruitment. 25.510 Section 25.510 Transportation Office of the Secretary of Transportation NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR... Education Programs or Activities Prohibited § 25.510 Recruitment. (a) Nondiscriminatory recruitment and...

Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

PubMed

Lundström, Erik; Isaksson, Eva; Wester, Per; Laska, Ann-Charlotte; Näsman, Per

2018-01-08

Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the

Recruitment of mental health survey participants using Internet advertising: content, characteristics and cost effectiveness.

PubMed

Batterham, Philip J

2014-06-01

Postal and telephone survey research is threatened by declining response rates and high cost. Online recruitment is becoming more popular, although there is little empirical evidence about its cost-effectiveness or the representativeness of online samples. There is also limited research on optimal strategies for developing advertising content for online recruitment. The present study aimed to assess these aspects of online recruitment. Two mental health surveys used advertisements within a social network website (Facebook) to recruit adult Australian participants. The initial survey used advertisements linking directly to an external survey website, and recruited 1283 participants at $9.82 per completed survey. A subsequent survey used advertisements linking to a Facebook page that featured links to the external survey, recruiting 610 participants at $1.51 per completion. Both surveys were more cost-effective than similar postal surveys conducted previously, which averaged $19.10 per completion. Online and postal surveys both had somewhat unrepresentative samples. However, online surveys tended to be more successful in recruiting hard-to-reach populations. Advertising using "problem" terminology was more effective than "positive" terminology, while there was no significant effect of altruistic versus self-gain terminology. Online recruitment is efficient, flexible and cost-effective, suggesting that online recruitment has considerable potential for specific research designs. Copyright © 2014 John Wiley & Sons, Ltd.

20 CFR 656.21 - Supervised recruitment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Supervised recruitment. 656.21 Section 656.21... Supervised recruitment. (a) Supervised recruitment. Where the Certifying Officer determines it appropriate, post-filing supervised recruitment may be required of the employer for the pending application or...