The Influence of Social Conditions Across the Life Course on the Human Gut Microbiota: A Pilot Project With the Wisconsin Longitudinal Study.

PubMed

Herd, Pamela; Schaeffer, Nora Cate; DiLoreto, Kerryann; Jacques, Karen; Stevenson, John; Rey, Federico; Roan, Carol

2017-12-15

To test the feasibility of collecting and integrating data on the gut microbiome into one of the most comprehensive longitudinal studies of aging and health, the Wisconsin Longitudinal Study (WLS). The long-term goal of this integration is to clarify the contribution of social conditions in shaping the composition of the gut microbiota late in life. Research on the microbiome, which is considered to be of parallel importance to human health as the human genome, has been hindered by human studies with nonrandomly selected samples and with limited data on social conditions over the life course. No existing population-based longitudinal study had collected fecal specimens. Consequently, we created an in-person protocol to collect stool specimens from a subgroup of WLS participants. We collected 429 stool specimens, yielding a 74% response rate and one of the largest human samples to date. The addition of data on the gut microbiome to the WLS-and to other population based longitudinal studies of aging-is feasible, under the right conditions, and can generate innovative research on the relationship between social conditions and the gut microbiome. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Effects of running-induced fatigue on plantar pressure distribution in novice runners with different foot types.

PubMed

Anbarian, Mehrdad; Esmaeili, Hamed

2016-07-01

This study aimed to assess the effects of running-induced fatigue on plantar pressure parameters in novice runners with low and high medial longitudinal arch. Plantar pressure data from 42 novice runners (21 with high, and 21 with low arch) were collected before and after running-induced fatigue protocol during running at 3.3m/s along the Footscan(®) platform. Peak plantar pressure, peak force and force-time integral (impulse) were measured in ten anatomical zones. Relative time for foot roll-over phases and medio-lateral force ratio were calculated before and after the fatigue protocol. After the fatigue protocol, increases in the peak pressure under the first-third metatarsal zones and reduction under the fourth-fifth metatarsal regions were observed in the low arch individuals. In the high arch group, increases in peak pressure under the fourth-fifth metatarsal zones after the running-induced fatigue was observed. It could be concluded that running-induced fatigue had different effects on plantar pressure distribution pattern among novice runners with low and high medial longitudinal foot arch. These findings could provide some information related to several running injuries among individuals with different foot types. Copyright © 2016 Elsevier B.V. All rights reserved.

High-capacity quantum secure direct communication with two-photon six-qubit hyperentangled states

NASA Astrophysics Data System (ADS)

Wu, FangZhou; Yang, GuoJian; Wang, HaiBo; Xiong, Jun; Alzahrani, Faris; Hobiny, Aatef; Deng, FuGuo

2017-12-01

This study proposes the first high-capacity quantum secure direct communication (QSDC) with two-photon six-qubit hyper-entangled Bell states in two longitudinal momentum and polarization degrees of freedom (DOFs) of photon pairs, which can be generated using two 0.5 mm-thick type-I β barium borate crystal slabs aligned one behind the other and an eight-hole screen. The secret message can be independently encoded on the photon pairs with 64 unitary operations in all three DOFs. This protocol has a higher capacity than previous QSDC protocols because each photon pair can carry 6 bits of information, not just 2 or 4 bits. Our QSDC protocol decreases the influence of decoherence from environment noise by exploiting the decoy photons to check the security of the transmission of the first photon sequence. Compared with two-way QSDC protocols, our QSDC protocol is immune to an attack by an eavesdropper using Trojan horse attack strategies because it is a one-way quantum communication. The QSDC protocol has good applications in the future quantum communication because of all these features.

High dose microCT does not contribute towards improved microPET/CT image quantitative accuracy and can limit longitudinal scanning of small animals

NASA Astrophysics Data System (ADS)

McDougald, Wendy A.; Collins, Richard; Green, Mark; Tavares, Adriana A. S.

2017-10-01

Obtaining accurate quantitative measurements in preclinical Positron Emission Tomography/Computed Tomography (PET/CT) imaging is of paramount importance in biomedical research and helps supporting efficient translation of preclinical results to the clinic. The purpose of this study was two-fold: (1) to investigate the effects of different CT acquisition protocols on PET/CT image quality and data quantification; and (2) to evaluate the absorbed dose associated with varying CT parameters. Methods: An air/water quality control CT phantom, tissue equivalent material phantom, an in-house 3D printed phantom and an image quality PET/CT phantom were imaged using a Mediso nanoPET/CT scanner. Collected data was analyzed using PMOD software, VivoQuant software and National Electric Manufactures Association (NEMA) software implemented by Mediso. Measured Hounsfield Unit (HU) in collected CT images were compared to the known HU values and image noise was quantified. PET recovery coefficients (RC), uniformity and quantitative bias were also measured. Results: Only less than 2% and 1% of CT acquisition protocols yielded water HU values < -80 and air HU values < -840, respectively. Four out of eleven CT protocols resulted in more than 100 mGy absorbed dose. Different CT protocols did not impact PET uniformity and RC, and resulted in <4% overall bias relative to expected radioactive concentration. Conclusion: Preclinical CT protocols with increased exposure times can result in high absorbed doses to the small animals. These should be avoided, as they do not contributed towards improved microPET/CT image quantitative accuracy and could limit longitudinal scanning of small animals.

In Vivo MRI Quantification of Individual Muscle and Organ Volumes for Assessment of Anabolic Steroid Growth Effects

PubMed Central

Wu, Ed X.; Tang, Haiying; Tong, Christopher; Heymsfield, Steve B.; Vasselli, Joseph R.

2015-01-01

This study aimed to develop a quantitative and in vivo magnetic resonance imaging (MRI) approach to investigate the muscle growth effects of anabolic steroids. A protocol of MRI acquisition on a standard clinical 1.5 Tesla scanner and quantitative image analysis was established and employed to measure the individual muscle and organ volumes in the intact and castrated guinea pigs undergoing a 16-week treatment protocol by two well-documented anabolic steroids, testosterone and nandrolone, via implanted silastic capsules. High correlations between the in vivo MRI and postmortem dissection measurements were observed for shoulder muscle complex (R = 0.86), masseter (R=0.79), temporalis (R=0.95), neck muscle complex (R=0.58), prostate gland and seminal vesicles (R=0.98), and testis (R=0.96). Furthermore, the longitudinal MRI measurements yielded adequate sensitivity to detect the restoration of growth to or towards normal in castrated guinea pigs by replacing circulating steroid levels to physiological or slightly higher levels, as expected. These results demonstrated that quantitative MRI using a standard clinical scanner provides accurate and sensitive measurement of individual muscles and organs, and this in vivo MRI protocol in conjunction with the castrated guinea pig model constitutes an effective platform to investigate the longitudinal and cross-sectional growth effects of other potential anabolic steroids. The quantitative MRI protocol developed can also be readily adapted for human studies on most clinical MRI scanner to investigate the anabolic steroid growth effects, or monitor the changes in individual muscle and organ volume and geometry following injury, strength training, neuromuscular disorders, and pharmacological or surgical interventions. PMID:18241900

Analysis of longitudinal data from animals where some data are missing in SPSS

PubMed Central

Duricki, DA; Soleman, S; Moon, LDF

2017-01-01

Testing of therapies for disease or injury often involves analysis of longitudinal data from animals. Modern analytical methods have advantages over conventional methods (particularly where some data are missing) yet are not used widely by pre-clinical researchers. We provide here an easy to use protocol for analysing longitudinal data from animals and present a click-by-click guide for performing suitable analyses using the statistical package SPSS. We guide readers through analysis of a real-life data set obtained when testing a therapy for brain injury (stroke) in elderly rats. We show that repeated measures analysis of covariance failed to detect a treatment effect when a few data points were missing (due to animal drop-out) whereas analysis using an alternative method detected a beneficial effect of treatment; specifically, we demonstrate the superiority of linear models (with various covariance structures) analysed using Restricted Maximum Likelihood estimation (to include all available data). This protocol takes two hours to follow. PMID:27196723

Sleep, biological stress, and health among toddlers living in socioeconomically disadvantaged homes: A research protocol.

PubMed

Ordway, Monica R; Sadler, Lois S; Canapari, Craig A; Jeon, Sangchoon; Redeker, Nancy S

2017-12-01

Healthy sleep is important to behavioral, neurobiological, and physiologic health. In older children and adults, stress biomarkers, such as cortisol and C-reactive protein, increase when they do not practice healthy sleep habits. However, little is known about the relationships among sleep health, stress, and health outcomes among very young children living with socioeconomic adversity, a group that is particularly at risk for poor future health. The NIH-funded study described in this protocol addresses this scientific gap to improve understanding of these relationships during a critical developmental period in children's lives-toddlerhood. We will use a longitudinal design with repeated measures to prospectively examine the relationships among sleep health, stress, and toddlers' health from age 12 to 24 months, to address the following aims: i) examine changes in subjective and objective sleep health measures; ii) examine changes in stress biomarkers; iii) examine the cross-sectional and longitudinal relationships between sleep health measures and stress response; and iv) examine the cross-sectional and longitudinal relationships between sleep health measures, stress biomarkers, and toddlers' behavioral health. The sample will include 113 toddlers and their caregivers. We are collecting subjective and objective data on sleep health, multi-systemic biomarkers of stress, and toddlers' behavioral health. Generalized linear models will be used in the data analyses. Results from this study will be used to support development and testing of interventions, such as those that may improve sleep, among young children at risk for toxic stress. © 2017 Wiley Periodicals, Inc.

Clinical Pharmacology Quality Assurance (CPQA) Program: Models for Longitudinal Analysis of Antiretroviral (ARV) Proficiency Testing for International Laboratories

PubMed Central

DiFrancesco, Robin; Rosenkranz, Susan L.; Taylor, Charlene R.; Pande, Poonam G.; Siminski, Suzanne M.; Jenny, Richard W.; Morse, Gene D.

2013-01-01

Among National Institutes of Health (NIH) HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals (ARV). Drug assay data are, in turn, entered into study-specific datasets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semi-annual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance (CPQA) program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1)assess the precision and accuracy of concentrations reported by individual CPLs; (2)determine factors associated with round-specific and long-term assay accuracy, precision and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21)drug concentration results reported for clinical trial samples by multiple CPLs).Using the CLIA acceptance of meeting criteria for ≥2/3 consecutive rounds, all ten laboratories that participated in three or more rounds per analyte maintained CLIA proficiency. Significant associations were present between magnitude of error and CPL (Kruskal Wallis [KW]p<0.001), and ARV (KW p<0.001). PMID:24052065

Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories.

PubMed

DiFrancesco, Robin; Rosenkranz, Susan L; Taylor, Charlene R; Pande, Poonam G; Siminski, Suzanne M; Jenny, Richard W; Morse, Gene D

2013-10-01

Among National Institutes of Health HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals. Drug assay data are, in turn, entered into study-specific data sets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis, and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semiannual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1) assess the precision and accuracy of concentrations reported by individual CPLs and (2) determine factors associated with round-specific and long-term assay accuracy, precision, and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21) drug concentration results reported for clinical trial samples by multiple CPLs). Using the Clinical Laboratory Improvement Act acceptance of meeting criteria for ≥2/3 consecutive rounds, all 10 laboratories that participated in 3 or more rounds per analyte maintained Clinical Laboratory Improvement Act proficiency. Significant associations were present between magnitude of error and CPL (Kruskal-Wallis P < 0.001) and antiretroviral (Kruskal-Wallis P < 0.001).

A Randomized Longitudinal Factorial Design to Assess Malaria Vector Control and Disease Management Interventions in Rural Tanzania

PubMed Central

Kramer, Randall A.; Mboera, Leonard E. G.; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H.; Paul, Christopher J.; Miranda, Marie Lynn

2014-01-01

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials. PMID:24840349

A randomized longitudinal factorial design to assess malaria vector control and disease management interventions in rural Tanzania.

PubMed

Kramer, Randall A; Mboera, Leonard E G; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H; Paul, Christopher J; Miranda, Marie Lynn

2014-05-16

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

Characterizing Design Cognition of High School Students: Initial Analyses Comparing Those with and without Pre-Engineering Experiences

ERIC Educational Resources Information Center

Wells, John; Lammi, Matthew; Gero, John; Grubbs, Michael E.; Paretti, Marie; Williams, Christopher

2016-01-01

Reported in this article are initial results from of a longitudinal study to characterize the design cognition and cognitive design styles of high school students with and without pre-engineering course experience over a 2-year period, and to compare them with undergraduate engineering students. The research followed a verbal protocol analysis…

Application of zero-inflated poisson mixed models in prognostic factors of hepatitis C.

PubMed

Akbarzadeh Baghban, Alireza; Pourhoseingholi, Asma; Zayeri, Farid; Jafari, Ali Akbar; Alavian, Seyed Moayed

2013-01-01

In recent years, hepatitis C virus (HCV) infection represents a major public health problem. Evaluation of risk factors is one of the solutions which help protect people from the infection. This study aims to employ zero-inflated Poisson mixed models to evaluate prognostic factors of hepatitis C. The data was collected from a longitudinal study during 2005-2010. First, mixed Poisson regression (PR) model was fitted to the data. Then, a mixed zero-inflated Poisson model was fitted with compound Poisson random effects. For evaluating the performance of the proposed mixed model, standard errors of estimators were compared. The results obtained from mixed PR showed that genotype 3 and treatment protocol were statistically significant. Results of zero-inflated Poisson mixed model showed that age, sex, genotypes 2 and 3, the treatment protocol, and having risk factors had significant effects on viral load of HCV patients. Of these two models, the estimators of zero-inflated Poisson mixed model had the minimum standard errors. The results showed that a mixed zero-inflated Poisson model was the almost best fit. The proposed model can capture serial dependence, additional overdispersion, and excess zeros in the longitudinal count data.

Does Partner Responsiveness Predict Hedonic and Eudaimonic Well-Being? A 10-Year Longitudinal Study

PubMed Central

Selcuk, Emre; Gunaydin, Gul; Ong, Anthony D.; Almeida, David M.

2017-01-01

Motivated by attachment theory and recent conceptualizations of perceived partner responsiveness as a core feature of close relationships, the present study examined change in hedonic and eudaimonic well-being over a decade in a sample of more than 2,000 married adults across the United States. Longitudinal analyses revealed that perceived partner responsiveness— the extent to which individuals believe that their partner cares for, appreciates, and understands them—predicted increases in eudaimonic well-being a decade later. These results remained after controlling for initial hedonic and eudaimonic well-being, age, gender, extraversion, neuroticism, and perceived responsiveness of family and friends. Affective reactivity, measured via an 8-day diary protocol in a subset of the sample, partially mediated this longitudinal association. After controlling for covariates, perceived partner responsiveness did not prospectively predict hedonic well-being. These findings are the first to document the long-term benefits of perceived partner responsiveness on eudaimonic well-being. PMID:28592909

Long term potentiation, but not depression, in interlamellar hippocampus CA1.

PubMed

Sun, Duk-Gyu; Kang, Hyeri; Tetteh, Hannah; Su, Junfeng; Lee, Jihwan; Park, Sung-Won; He, Jufang; Jo, Jihoon; Yang, Sungchil; Yang, Sunggu

2018-03-26

Synaptic plasticity in the lamellar CA3 to CA1 circuitry has been extensively studied while interlamellar CA1 to CA1 connections have not yet received much attention. One of our earlier studies demonstrated that axons of CA1 pyramidal neurons project to neighboring CA1 neurons, implicating information transfer along a longitudinal interlamellar network. Still, it remains unclear whether long-term synaptic plasticity is present within this longitudinal CA1 network. Here, we investigate long-term synaptic plasticity between CA1 pyramidal cells, using in vitro and in vivo extracellular recordings and 3D holography glutamate uncaging. We found that the CA1-CA1 network exhibits NMDA receptor-dependent long-term potentiation (LTP) without direction or layer selectivity. By contrast, we find no significant long-term depression (LTD) under various LTD induction protocols. These results implicate unique synaptic properties in the longitudinal projection suggesting that the interlamellar CA1 network could be a promising structure for hippocampus-related information processing and brain diseases.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

PubMed Central

Agot, Kawango

2017-01-01

Background Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. Conclusions The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. Trial Registration ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54) PMID:28274904

Study of Use of Products and Exposure-Related Behaviors (SUPERB): study design, methods, and demographic characteristics of cohorts

PubMed Central

2010-01-01

Background Exposure to toxic chemicals in the home is a growing concern. This report presents an overview of the recruitment, methods for data collection, instruments used to collect data, and participant demographics for a study examining behaviors that influence exposure to environmental toxins in the home environment, also known as SUPERB (Study of Use of Products and Exposure Related Behaviors). Methods The methods involved three different platforms: telephone interviews, internet-based surveys, and home-based monitoring. The purposes of SUPERB were: first, to compare data collection platforms with regard to feasibility, acceptability and reliability; and second, to provide longitudinal population-based data characterizing seasonal and long-term changes in exposure-related behaviors including food consumption, temporal-spatial activity, and household product use. Results Two cohorts of households were enrolled: families (one parent and one child) from northern California and older individuals (age 55+) from central California. Parents (n = 499) in Northern California families were on average 36 years of age, 47.1% were Latino or nonwhite, and 10.2% took the survey in Spanish. Most of the children enrolled (n = 566) were under 6 years (82.7%). The older adults enrolled (n = 156) were, on average, 66 years of age and 23.7% were Latino or nonwhite, but only 2.6% completed the survey in Spanish. Conclusions We found that oversampling was successful in improving recruitment of under-represented subgroups, such as those with low education, thereby increasing diversity of our study sample. Protocols that minimize participant time, e.g., use of bar scanners and scales rather than questionnaires regarding use of household products, and the implementation of these protocols by staff who built relationships of trust, resulted in high retention over a longitudinal data collection scheme. A relatively small fraction of those who volunteer for longitudinal internet surveys are consistent in filling them out. Future reports will provide critical information on cross-sectional, seasonal and longitudinal patterns of exposure related behaviors in young children, parents of young children, and older adults. PMID:20799988

Analysis of longitudinal data from animals with missing values using SPSS.

PubMed

Duricki, Denise A; Soleman, Sara; Moon, Lawrence D F

2016-06-01

Testing of therapies for disease or injury often involves the analysis of longitudinal data from animals. Modern analytical methods have advantages over conventional methods (particularly when some data are missing), yet they are not used widely by preclinical researchers. Here we provide an easy-to-use protocol for the analysis of longitudinal data from animals, and we present a click-by-click guide for performing suitable analyses using the statistical package IBM SPSS Statistics software (SPSS). We guide readers through the analysis of a real-life data set obtained when testing a therapy for brain injury (stroke) in elderly rats. If a few data points are missing, as in this example data set (for example, because of animal dropout), repeated-measures analysis of covariance may fail to detect a treatment effect. An alternative analysis method, such as the use of linear models (with various covariance structures), and analysis using restricted maximum likelihood estimation (to include all available data) can be used to better detect treatment effects. This protocol takes 2 h to carry out.

THE COOPERATIVE INTERNATIONAL NEUROMUSCULAR RESEARCH GROUP DUCHENNE NATURAL HISTORY STUDY—A LONGITUDINAL INVESTIGATION IN THE ERA OF GLUCOCORTICOID THERAPY: DESIGN OF PROTOCOL AND THE METHODS USED

PubMed Central

McDonald, Craig M.; Henricson, Erik K.; Abresch, R. Ted; Han, Jay J.; Escolar, Diana M.; Florence, Julaine M.; Duong, Tina; Arrieta, Adrienne; Clemens, Paula R.; Hoffman, Eric P.; Cnaan, Avital

2014-01-01

Contemporary natural history data in Duchenne muscular dystrophy (DMD) is needed to assess care recommendations and aid in planning future trials. Methods The Cooperative International Neuromuscular Research Group (CINRG) DMD Natural History Study (DMD-NHS) enrolled 340 individuals, aged 2–28 years, with DMD in a longitudinal, observational study at 20 centers. Assessments obtained every 3 months for 1 year, at 18 months, and annually thereafter included: clinical history; anthropometrics; goniometry; manual muscle testing; quantitative muscle strength; timed function tests; pulmonary function; and patient-reported outcomes/ health-related quality-of-life instruments. Results Glucocorticoid (GC) use at baseline was 62% present, 14% past, and 24% GC-naive. In those ≥6 years of age, 16% lost ambulation over the first 12 months (mean age 10.8 years). Conclusions Detailed information on the study methodology of the CINRG DMD-NHS lays the groundwork for future analyses of prospective longitudinal natural history data. These data will assist investigators in designing clinical trials of novel therapeutics. PMID:23677550

An unusual stress fracture: Bilateral posterior longitudinal stress fracture of tibia.

PubMed

Malkoc, Melih; Korkmaz, Ozgur; Ormeci, Tugrul; Oltulu, Ismail; Isyar, Mehmet; Mahirogulları, Mahir

2014-01-01

Stress fractures (SF) occur when healthy bone is subjected to cyclic loading, which the normal carrying range capacity is exceeded. Usually, stress fractures occur at the metatarsal bones, calcaneus, proximal or distal tibia and tends to be unilateral. This article presents a 58-year-old male patient with bilateral posterior longitudinal tibial stress fractures. A 58 years old male suffering for persistent left calf pain and decreased walking distance for last one month and after imaging studies posterior longitudinal tibial stress fracture was detected on his left tibia. After six months the patient was admitted to our clinic with the same type of complaints in his right leg. All imaging modalities and blood counts were performed and as a result longitudinal posterior tibial stress fractures were detected on his right tibia. Treatment of tibial stress fracture includes rest and modified activity, followed by a graded return to activity commensurate with bony healing. We have applied the same treatment protocol and our results were acceptable but our follow up time short for this reason our study is restricted for separate stress fractures of the posterior tibia. Although the main localization of tibial stress fractures were unilateral, anterior and transverse pattern, rarely, like in our case, the unusual bilateral posterior localization and longitudinal pattern can be seen. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Rural habitat as risk factor for hepatitis E virus seroconversion in HIV-infected patients: A prospective longitudinal study.

PubMed

Rivero-Juarez, A; Cuenca-Lopez, F; Martinez-Peinado, A; Camacho, A; Real, L M; Frias, M; Gordon, A; Cantisán, S; Torre-Cisneros, J; Pineda, J A; Rivero, A

2017-11-01

Our objective was to determine the incidence and clinical manifestations of acute hepatitis E virus (HEV) in HIV-infected patients. A prospective longitudinal study including HIV-infected HEV-seronegative patients was conducted; HEV seroconversion (to IgG and/or IgM) was the main outcome variable. All patients were tested for HEV antibodies every 3-6 months. For patients who developed HEV seroconversion, a data collection protocol was followed to identify associated clinical manifestations and analytical alterations. A total of 627 patients (89.9%) were followed during a median of 11.96 months (IQR: 8.52-14.52 months) and formed the study population. Forty-one patients developed detectable anti-HEV antibodies (7.2 cases per 100 patients/year). Our study found a high incidence of HEV in HIV-infected patients in southern Spain strongly associated with a rural habitat. © 2017 Blackwell Verlag GmbH.

Longitudinal assessment of brain-derived neurotrophic factor in Sardinian psychotic patients (LABSP): a protocol for a prospective observational study

PubMed Central

Primavera, Diego; Deriu, Luca; Collu, Roberto; Scherma, Maria; Fadda, Paola; Fratta, Walter; Carpiniello, Bernardo

2017-01-01

Introduction Brain-derived neurotrophic factor (BDNF) plays a crucial role in neurodevelopment, synaptic plasticity and neuronal function and survival. Serum and plasma BDNF levels are moderately, but consistently, decreased in patients with schizophrenia (SCZ) compared with healthy controls. There is a lack of knowledge, however, on the temporal manifestation of this decline. Clinical, illness course and treatment factors might influence the variation of BDNF serum levels in patients with psychosis. In this context, we propose a longitudinal study of a cohort of SCZ and schizophrenic and schizoaffective disorder (SAD) Sardinian patients with the aim of disentangling the relationship between peripheral BDNF serum levels and changes of psychopathology, cognition and drug treatments. Methods and analysis Longitudinal assessment of BDNF in Sardinian psychotic patients (LABSP) is a 24-month observational prospective cohort study. Patients with SAD will be recruited at the Psychiatry Research Unit of the Department of Medical Science and Public Health, University of Cagliari and University of Cagliari Health Agency, Cagliari, Italy. We will collect BDNF serum levels as well as sociodemographic, psychopathological and neurocognitive measures. Structured, semistructured and self-rating assessment tools, such as the Positive and Negative Syndrome Scale for psychopathological measures and the Brief Assessment of Cognition in Schizophrenia for cognitive function, will be used. Ethics and dissemination This study protocol was approved by the University of Cagliari Health Agency Ethics Committee (NP2016/5491). The study will be conducted in accordance with the principles of good clinical practice, in the Declaration of Helsinki in compliance with the regulations. Participation will be voluntary and written informed consent will be obtained for each participant upon entry into the study. We plan to disseminate the results of our study through conference presentations and publication in international peer-reviewed journals. Access to raw data will be available in anonymised form upon request to the corresponding author. PMID:28550022

Physical Activity and Motor Competence Present a Positive Reciprocal Longitudinal Relationship Across Childhood and Early Adolescence.

PubMed

Lima, Rodrigo A; Pfeiffer, Karin; Larsen, Lisbeth R; Bugge, Anna; Moller, Niels C; Anderson, Lars B; Stodden, David F

2017-06-01

The current study evaluated the reciprocal longitudinal relationship between physical activity (PA) and motor competence (MC) and the potential mediation of cardiorespiratory endurance across 7 years. This was a 7-year longitudinal study, the Copenhagen School Child Intervention Study (CoSCIS), with 3 measuring points [mean ages (in years) and respective sample size: 6.75 ± 0.37, n = 696; 9.59 ± 1.07, n = 617; 13.35 ± 0.34, n = 513]. PA was assessed using accelerometers. MC was evaluated by the Körperkoordinationstest für Kinder (KTK) test battery. Cardiorespiratory fitness (VO 2 peak) was evaluated using a continuous running protocol until exhaustion. Structural equation modeling was performed to evaluate the longitudinal associations. Vigorous PA (VPA) and MC presented reciprocal longitudinal association during the 7-year follow-up (VPA → MC; β = 0.18; 95% CI: 0.10, 0.26; MC → VPA; β = 0.14; 95% CI: 0.08, 0.21). In addition, VO 2 peak mediated the relationship in both directions (VPA → MC; β = 0.09; 95% CI: 0.06, 0.12; MC → VPA; β = 0.06; 95% CI: 0.03, 0.09). PA and MC presented a positive reciprocal relationship across childhood through early adolescence and VO 2 peak mediated the association in both directions. Interventions targeting to increase PA in children and adolescents should also address the development of MC skills because of the clear positive feedback loop between PA and MC.

Electrical Stimulation of Coleopteran Muscle for Initiating Flight.

PubMed

Choo, Hao Yu; Li, Yao; Cao, Feng; Sato, Hirotaka

2016-01-01

Some researchers have long been interested in reconstructing natural insects into steerable robots or vehicles. However, until recently, these so-called cyborg insects, biobots, or living machines existed only in science fiction. Owing to recent advances in nano/micro manufacturing, data processing, and anatomical and physiological biology, we can now stimulate living insects to induce user-desired motor actions and behaviors. To improve the practicality and applicability of airborne cyborg insects, a reliable and controllable flight initiation protocol is required. This study demonstrates an electrical stimulation protocol that initiates flight in a beetle (Mecynorrhina torquata, Coleoptera). A reliable stimulation protocol was determined by analyzing a pair of dorsal longitudinal muscles (DLMs), flight muscles that oscillate the wings. DLM stimulation has achieved with a high success rate (> 90%), rapid response time (< 1.0 s), and small variation (< 0.33 s; indicating little habituation). Notably, the stimulation of DLMs caused no crucial damage to the free flight ability. In contrast, stimulation of optic lobes, which was earlier demonstrated as a successful flight initiation protocol, destabilized the beetle in flight. Thus, DLM stimulation is a promising secure protocol for inducing flight in cyborg insects or biobots.

Electrical Stimulation of Coleopteran Muscle for Initiating Flight

PubMed Central

Choo, Hao Yu; Li, Yao; Cao, Feng; Sato, Hirotaka

2016-01-01

Some researchers have long been interested in reconstructing natural insects into steerable robots or vehicles. However, until recently, these so-called cyborg insects, biobots, or living machines existed only in science fiction. Owing to recent advances in nano/micro manufacturing, data processing, and anatomical and physiological biology, we can now stimulate living insects to induce user-desired motor actions and behaviors. To improve the practicality and applicability of airborne cyborg insects, a reliable and controllable flight initiation protocol is required. This study demonstrates an electrical stimulation protocol that initiates flight in a beetle (Mecynorrhina torquata, Coleoptera). A reliable stimulation protocol was determined by analyzing a pair of dorsal longitudinal muscles (DLMs), flight muscles that oscillate the wings. DLM stimulation has achieved with a high success rate (> 90%), rapid response time (< 1.0 s), and small variation (< 0.33 s; indicating little habituation). Notably, the stimulation of DLMs caused no crucial damage to the free flight ability. In contrast, stimulation of optic lobes, which was earlier demonstrated as a successful flight initiation protocol, destabilized the beetle in flight. Thus, DLM stimulation is a promising secure protocol for inducing flight in cyborg insects or biobots. PMID:27050093

Successful minority recruitment and adherence in physical activity Internet-based research: the WIN study.

PubMed

Frierson, Georita M; Morrow, James R; Vidales, Andrew

2012-01-01

Researchers studying physical activity often face challenges dealing with recruitment and resources, particularly when conducting longitudinal Internet-based research. Commonly raised methodological problems such as minority recruitment, participant commitment, and participant-staff involvement are addressed through a theoretically driven recruitment and adherence protocol in The Women's Exercise Injuries: Incidence and Risk Factors (WIN) Internet-based study. The objectives of this paper were to review and suggest solutions to problems of: (1) low recruitment of diverse samples, (2) low adherence, and (3) staffing needs. We recruited 1303 community-dwelling women and followed them through a multiple-phase, longitudinal, Internet-based study. Recruitment and adherence data were analyzed through descriptive methods and logistic regressions to examine participant adherence and sociodemographic factors and predictors of who entered the long-term phase of the study. We successfully retained 71.6% of the sample through 4 recruitment phases. Twenty-seven percent of the initially recruited sample was racial/ethnically diverse, 24% began the long-term phase, and 23% completed. Several strategies to enhance participant commitment were successfully used during the practice phase, providing a successful, low staff to participant ratio. Logistic regression indicated being married, being older, and having greater Internet skills were predictive of successfully entering the long-term phase of the study. Recruitment and compliance protocols were successful in meeting overall and racial/ethnic enrollment and recruitment goals. The theoretically based practice phase techniques were successful in re-engaging noncompliant participants. Strategies for minority enrollment and compliance are evaluated.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

PubMed

Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

2017-03-08

Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54). ©Jasmine Buttolph, Irene Inwani, Kawango Agot, Charles M Cleland, Peter Cherutich, James N Kiarie, Alfred Osoti, Connie L Celum, Jared M Baeten, Ruth Nduati, John Kinuthia, Timothy B Hallett, Ramzi Alsallaq, Ann E Kurth. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.03.2017.

Assessing corporate project impacts in changeable contexts: A human rights perspective

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

Salcito, Kendyl, E-mail: kendyl.salcito@unibas.ch; University of Basel, P.O. Box, CH-4003 Basel; NomoGaia, 1900 Wazee Street, Suite 303, Denver, CO 80202

Project-level impact assessment was originally conceived as a snapshot taken in advance of project implementation, contrasting current conditions with a likely future scenario involving a variety of predicted impacts. Current best practice guidance has encouraged a shift towards longitudinal assessments from the pre-project stage through the implementation and operating phases. Experience and study show, however, that assessment of infrastructure-intensive projects rarely endures past the project's construction phase. Negative consequences for environmental, social and health outcomes have been documented. Such consequences clarify the pressing need for longitudinal assessment in each of these domains, with human rights impact assessment (HRIA) as anmore » umbrella over, and critical augmentation of, environmental, social and health assessments. Project impacts on human rights are more closely linked to political, economic and other factors beyond immediate effects of a company's policy and action throughout the project lifecycle. Delineating these processes requires an adequate framework, with strategies for collecting longitudinal data, protocols that provide core information for impact assessment and guidance for adaptive mitigation strategies as project-related effects change over time. This article presents general principles for the design and implementation of sustained, longitudinal HRIA, based on experience assessing and responding to human rights impact in a uranium mining project in Malawi. The case study demonstrates the value of longitudinal assessment both for limiting corporate risk and improving human welfare. - Graphical abstract: Assessing changes in human rights condition as affected by both project and context, over time. - Highlights: • Corporate capital projects affect human rights in myriad ways. • Ongoing, longitudinal impact assessment techniques are needed. • We present an approach for conducting longitudinal human rights impact assessment. • Our methodology allows distinguishing corporate impacts from contextual changes. • Promptly observing context changes and impacts enables companies to react nimbly.« less

Effectiveness and Value of Prophylactic 5-Layer Foam Sacral Dressings to Prevent Hospital-Acquired Pressure Injuries in Acute Care Hospitals: An Observational Cohort Study.

PubMed

Padula, William V

The purpose of this study was to examine the effectiveness and value of prophylactic 5-layer foam sacral dressings to prevent hospital-acquired pressure injury rates in acute care settings. Retrospective observational cohort. We reviewed records of adult patients 18 years or older who were hospitalized at least 5 days across 38 acute care hospitals of the University Health System Consortium (UHC) and had a pressure injury as identified by Patient Safety Indicator #3 (PSI-03). All facilities are located in the United States. We collected longitudinal data pertaining to prophylactic 5-layer foam sacral dressings purchased by hospital-quarter for 38 academic medical centers between 2010 and 2015. Longitudinal data on acute care, hospital-level patient outcomes (eg, admissions and PSI-03 and pressure injury rate) were queried through the UHC clinical database/resource manager from the Johns Hopkins Medicine portal. Data on volumes of dressings purchased per UHC hospital were merged with UHC data. Mixed-effects negative binomial regression was used to test the longitudinal association of prophylactic foam sacral dressings on pressure injury rates, adjusted for hospital case-mix and Medicare payments rules. Significant pressure injury rate reductions in US acute care hospitals between 2010 and 2015 were associated with the adoption of prophylactic 5-layer foam sacral dressings within a prevention protocol (-1.0 cases/quarter; P = .002) and changes to Medicare payment rules in 2014 (-1.13 cases/quarter; P = .035). Prophylactic 5-layer foam sacral dressings are an effective component of a pressure injury prevention protocol. Hospitals adopting these technologies should expect good value for use of these products.

Longitudinal Assessment of Neurocognitive Outcomes in Survivors of Childhood Acute Lymphoblastic Leukemia Treated on a Contemporary Chemotherapy Protocol.

PubMed

Jacola, Lisa M; Krull, Kevin R; Pui, Ching-Hon; Pei, Deqing; Cheng, Cheng; Reddick, Wilburn E; Conklin, Heather M

2016-04-10

Survivors of childhood acute lymphoblastic leukemia (ALL) treated with CNS-directed chemotherapy are at risk for neurocognitive deficits. Prospective longitudinal studies are needed to clarify the neurodevelopmental trajectory in this vulnerable population. Patients enrolled in the St. Jude Total Therapy Study XV, which omitted prophylactic cranial radiation therapy in all patients, completed comprehensive neuropsychological assessments at induction (n = 142), end of maintenance (n = 243), and 2 years after completion of therapy (n = 211). We report on longitudinal change in neurocognitive function and predictors of neurocognitive outcomes 2 years after completing therapy. Neurocognitive function was largely age appropriate 2 years after completing therapy; however, the overall group demonstrated significant attention deficits and a significantly greater frequency of learning problems as compared with national normative data (all P ≤ .005). Higher-intensity CNS-directed chemotherapy conferred elevated risk for difficulties in attention, processing speed, and academics (all P ≤ .01). The rate and direction of change in performance and caregiver-reported attention difficulties differed significantly by age at diagnosis and sex. End-of-therapy attention problems predicted lower academic scores 2 years later, with small to moderate effect sizes (│r│= 0.17 to 0.25, all P ≤ .05). Two years after chemotherapy-only treatment, neurocognitive function is largely age appropriate. Nonetheless, survivors remain at elevated risk for attention problems that impact real-world functioning. Attention problems at the end of therapy predicted decreased academics 2 years later, suggesting an amplified functional impact of discrete neurocognitive difficulties. Age at diagnosis and patient sex may alter neurocognitive development in survivors of childhood ALL treated with chemotherapy-only protocols. © 2016 by American Society of Clinical Oncology.

Optimizing a dynamical decoupling protocol for solid-state electronic spin ensembles in diamond

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

Farfurnik, D.; Jarmola, A.; Pham, L. M.

2015-08-24

In this study, we demonstrate significant improvements of the spin coherence time of a dense ensemble of nitrogen-vacancy (NV) centers in diamond through optimized dynamical decoupling (DD). Cooling the sample down to 77 K suppresses longitudinal spin relaxation T 1 effects and DD microwave pulses are used to increase the transverse coherence time T 2 from ~0.7ms up to ~30ms. Furthermore, we extend previous work of single-axis (Carr-Purcell-Meiboom-Gill) DD towards the preservation of arbitrary spin states. Following a theoretical and experimental characterization of pulse and detuning errors, we compare the performance of various DD protocols. We also identify that themore » optimal control scheme for preserving an arbitrary spin state is a recursive protocol, the concatenated version of the XY8 pulse sequence. The improved spin coherence might have an immediate impact on improvements of the sensitivities of ac magnetometry. Moreover, the protocol can be used on denser diamond samples to increase coherence times up to NV-NV interaction time scales, a major step towards the creation of quantum collective NV spin states.« less

Study protocol for evaluating the implementation and effectiveness of an emergency department longitudinal patient monitoring system using a mixed-methods approach.

PubMed

Ward, Marie; McAuliffe, Eilish; Wakai, Abel; Geary, Una; Browne, John; Deasy, Conor; Schull, Michael; Boland, Fiona; McDaid, Fiona; Coughlan, Eoin; O'Sullivan, Ronan

2017-01-23

Early detection of patient deterioration is a key element of patient safety as it allows timely clinical intervention and potential rescue, thus reducing the risks of serious patient safety incidents. Longitudinal patient monitoring systems have been widely recommended for use to detect clinical deterioration. However, there is conflicting evidence on whether they improve patient outcomes. This may in part be related to variation in the rigour with which they are implemented and evaluated. This study aims to evaluate the implementation and effectiveness of a longitudinal patient monitoring system designed for adult patients in the unique environment of the Emergency Department (ED). A novel participatory action research (PAR) approach is taken where socio-technical systems (STS) theory and analysis informs the implementation through the improvement methodology of 'Plan Do Study Act' (PDSA) cycles. We hypothesise that conducting an STS analysis of the ED before beginning the PDSA cycles will provide for a much richer understanding of the current situation and possible challenges to implementing the ED-specific longitudinal patient monitoring system. This methodology will enable both a process and an outcome evaluation of implementing the ED-specific longitudinal patient monitoring system. Process evaluations can help distinguish between interventions that have inherent faults and those that are badly executed. Over 1.2 million patients attend EDs annually in Ireland; the successful implementation of an ED-specific longitudinal patient monitoring system has the potential to affect the care of a significant number of such patients. To the best of our knowledge, this is the first study combining PAR, STS and multiple PDSA cycles to evaluate the implementation of an ED-specific longitudinal patient monitoring system and to determine (through process and outcome evaluation) whether this system can significantly improve patient outcomes by early detection and appropriate intervention for patients at risk of clinical deterioration.

Bidirectional Relations between Parenting Practices and Child Externalizing Behavior: A Cross-Lagged Panel Analysis in the Context of a Psychosocial Treatment and 3-Year Follow-up

ERIC Educational Resources Information Center

Shaffer, Anne; Lindhiem, Oliver; Kolko, David J.; Trentacosta, Christopher J.

2013-01-01

In the current study, we examined longitudinal changes in, and bidirectional effects between, parenting practices and child behavior problems in the context of a psychosocial treatment and 3-year follow-up period. The sample comprised 139 parent-child dyads (child ages 6-11) who participated in a modular treatment protocol for early-onset ODD or…

Development of a protocol to quantify local bone adaptation over space and time: Quantification of reproducibility.

PubMed

Lu, Yongtao; Boudiffa, Maya; Dall'Ara, Enrico; Bellantuono, Ilaria; Viceconti, Marco

2016-07-05

In vivo micro-computed tomography (µCT) scanning of small rodents is a powerful method for longitudinal monitoring of bone adaptation. However, the life-time bone growth in small rodents makes it a challenge to quantify local bone adaptation. Therefore, the aim of this study was to develop a protocol, which can take into account large bone growth, to quantify local bone adaptations over space and time. The entire right tibiae of eight 14-week-old C57BL/6J female mice were consecutively scanned four times in an in vivo µCT scanner using a nominal isotropic image voxel size of 10.4µm. The repeated scan image datasets were aligned to the corresponding baseline (first) scan image dataset using rigid registration. 80% of tibia length (starting from the endpoint of the proximal growth plate) was selected as the volume of interest and partitioned into 40 regions along the tibial long axis (10 divisions) and in the cross-section (4 sectors). The bone mineral content (BMC) was used to quantify bone adaptation and was calculated in each region. All local BMCs have precision errors (PE%CV) of less than 3.5% (24 out of 40 regions have PE%CV of less than 2%), least significant changes (LSCs) of less than 3.8%, and 38 out of 40 regions have intraclass correlation coefficients (ICCs) of over 0.8. The proposed protocol allows to quantify local bone adaptations over an entire tibia in longitudinal studies, with a high reproducibility, an essential requirement to reduce the number of animals to achieve the necessary statistical power. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

A Murine Model of Robotic Training to Evaluate Skeletal Muscle Recovery after Injury.

PubMed

Lai, Stefano; Panarese, Alessandro; Lawrence, Ross; Boninger, Michael L; Micera, Silvestro; Ambrosio, Fabrisia

2017-04-01

In vivo studies have suggested that motor exercise can improve muscle regeneration after injury. Nevertheless, preclinical investigations still lack reliable tools to monitor motor performance over time and to deliver optimal training protocols to maximize force recovery. Here, we evaluated the utility of a murine robotic platform (i) to detect early impairment and longitudinal recovery after acute skeletal muscle injury and (ii) to administer varying intensity training protocols to enhance forelimb motor performance. A custom-designed robotic platform was used to train mice to perform a forelimb retraction task. After an acute injury to bilateral biceps brachii muscles, animals performed a daily training protocol in the platform at high (HL) or low (LL) loading levels over the course of 3 wk. Control animals were not trained (NT). Motor performance was assessed by quantifying force, time, submovement count, and number of movement attempts to accomplish the task. Myofiber number and cross-sectional area at the injury site were quantified histologically. Two days after injury, significant differences in the time, submovement count, number of movement attempts, and exerted force were observed in all mice, as compared with baseline values. Interestingly, the recovery time of muscle force production differed significantly between intervention groups, with HL group showing a significantly accelerated recovery. Three weeks after injury, all groups showed motor performance comparable with baseline values. Accordingly, there were no differences in the number of myofibers or average cross-sectional area among groups after 3 wk. Our findings demonstrate the utility of our custom-designed robotic device for the quantitative assessment of skeletal muscle function in preclinical murine studies. Moreover, we demonstrate that this device may be used to apply varying levels of resistance longitudinally as a means manipulate physiological muscle responses.

An introduction to the Emergency Department Adult Clinical Escalation protocol: ED-ACE.

PubMed

Coughlan, Eoin; Geary, Una; Wakai, Abel; O'Sullivan, Ronan; Browne, John; McAuliffe, Eilish; Ward, Marie; McDaid, Fiona; Deasy, Conor

2017-09-01

This study demonstrates how a participatory action research approach was used to address the challenge of the early and effective detection of the deteriorating patient in the ED setting. The approach enabled a systematic approach to patient monitoring and escalation of care to be developed to address the wide-ranging spectrum of undifferentiated presentations and the phases of ED care from triage to patient admission. This paper presents a longitudinal patient monitoring system, which aims to provide monitoring and escalation of care, where necessary, of adult patients from triage to admission to hospital in a manner that is feasible in the unique ED environment. An action research approach was taken to designing a longitudinal patient monitoring system appropriate for the ED. While the first draft protocol for post-triage monitoring and escalation was designed by a core research group, six clinical sites were included in iterative cycles of planning, action, reviewing and further planning. Reasons for refining the system at each site were collated and the protocol was adjusted accordingly before commencing the process at the next site. The ED Adult Clinical Escalation longitudinal patient monitoring system (ED-ACE) evolved through iterative cycles of design and testing to include: (1) a monitoring chart for adult patients; (2) a standardised approach to the monitoring and reassessment of patients after triage until they are assessed by a clinician; (3) the ISBAR (I=Identify, S=Situation, B=Background, A=Assessment, R=Recommendation) tool for interprofessional communication relating to clinical escalation; (4) a template for prescribing a patient-specific monitoring plan to be used by treating clinicians to guide patient monitoring from the time the patient is assessed until when they leave the ED and (5) a protocol for clinical escalation prompted by single physiological triggers and clinical concern. This tool offers a link in the 'Chain of Prevention' between the Manchester Triage System and ward-based early warning scores taking account of the importance of standardisation, while being sufficiently adaptable for the unique working environment and patient population in the ED. 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 CogBIAS longitudinal study protocol: cognitive and genetic factors influencing psychological functioning in adolescence.

PubMed

Booth, Charlotte; Songco, Annabel; Parsons, Sam; Heathcote, Lauren; Vincent, John; Keers, Robert; Fox, Elaine

2017-12-29

Optimal psychological development is dependent upon a complex interplay between individual and situational factors. Investigating the development of these factors in adolescence will help to improve understanding of emotional vulnerability and resilience. The CogBIAS longitudinal study (CogBIAS-L-S) aims to combine cognitive and genetic approaches to investigate risk and protective factors associated with the development of mood and impulsivity-related outcomes in an adolescent sample. CogBIAS-L-S is a three-wave longitudinal study of typically developing adolescents conducted over 4 years, with data collection at age 12, 14 and 16. At each wave participants will undergo multiple assessments including a range of selective cognitive processing tasks (e.g. attention bias, interpretation bias, memory bias) and psychological self-report measures (e.g. anxiety, depression, resilience). Saliva samples will also be collected at the baseline assessment for genetic analyses. Multilevel statistical analyses will be performed to investigate the developmental trajectory of cognitive biases on psychological functioning, as well as the influence of genetic moderation on these relationships. CogBIAS-L-S represents the first longitudinal study to assess multiple cognitive biases across adolescent development and the largest study of its kind to collect genetic data. It therefore provides a unique opportunity to understand how genes and the environment influence the development and maintenance of cognitive biases and provide insight into risk and protective factors that may be key targets for intervention.

Adaptive quantification and longitudinal analysis of pulmonary emphysema with a hidden Markov measure field model.

PubMed

Hame, Yrjo; Angelini, Elsa D; Hoffman, Eric A; Barr, R Graham; Laine, Andrew F

2014-07-01

The extent of pulmonary emphysema is commonly estimated from CT scans by computing the proportional area of voxels below a predefined attenuation threshold. However, the reliability of this approach is limited by several factors that affect the CT intensity distributions in the lung. This work presents a novel method for emphysema quantification, based on parametric modeling of intensity distributions and a hidden Markov measure field model to segment emphysematous regions. The framework adapts to the characteristics of an image to ensure a robust quantification of emphysema under varying CT imaging protocols, and differences in parenchymal intensity distributions due to factors such as inspiration level. Compared to standard approaches, the presented model involves a larger number of parameters, most of which can be estimated from data, to handle the variability encountered in lung CT scans. The method was applied on a longitudinal data set with 87 subjects and a total of 365 scans acquired with varying imaging protocols. The resulting emphysema estimates had very high intra-subject correlation values. By reducing sensitivity to changes in imaging protocol, the method provides a more robust estimate than standard approaches. The generated emphysema delineations promise advantages for regional analysis of emphysema extent and progression.

Adapting an evidence-based model to retain adolescent study participants in longitudinal research.

PubMed

Davis, Erin; Demby, Hilary; Jenner, Lynne Woodward; Gregory, Alethia; Broussard, Marsha

2016-02-01

Maintaining contact with and collecting outcome data from adolescent study participants can present a significant challenge for researchers conducting longitudinal studies. Establishing an organized and effective protocol for participant follow-up is crucial to reduce attrition and maintain high retention rates. This paper describes our methods in using and adapting the evidence-based Engagement, Verification, Maintenance, and Confirmation (EVMC) model to follow up with adolescents 6 and 12 months after implementation of a health program. It extends previous research by focusing on two key modifications to the model: (1) the central role of cell phones and texting to maintain contact with study participants throughout the EVMC process and, (2) use of responsive two-way communication between staff and participants and flexible administration modes and methods in the confirmation phase to ensure that busy teens not only respond to contacts, but also complete data collection. These strategies have resulted in high overall retention rates (87-91%) with adolescent study participants at each follow-up data collection point without the utilization of other, more involved tracking measures. The methods and findings presented may be valuable for other researchers with limited resources planning for or engaged in collecting follow-up outcome data from adolescents enrolled in longitudinal studies. Copyright © 2015. Published by Elsevier Ltd.

Long-term variability of sleep bruxism and psychological stress in patients with jaw-muscle pain: Report of two longitudinal clinical cases.

PubMed

Muzalev, K; Visscher, C M; Koutris, M; Lobbezoo, F

2018-02-01

Sleep bruxism (SB) and psychological stress are commonly considered as contributing factors in the aetiology of temporomandibular disorder (TMD) pain. However, the lack of longitudinal studies and fluctuating nature of SB, psychological stress and TMD pain have led to contradictory results regarding the association between the possible aetiological factors and TMD pain. In the present study we investigated the contribution of SB and psychological stress to TMD pain in a longitudinal study of 2 clinical TMD pain cases during a 6-week study protocol. Two female volunteers with clinically diagnosed myalgia based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) participated in the study. Questionnaires were used to record jaw-muscle pain and psychological stress experience, and an ambulatory polysomnography technique was used to record SB intensity. Visual analysis of the data revealed that the intensity of TMD pain was not hardwired, neither with psychological stress experience nor with increased SB activity. Within the limitations of single-patient clinical cases design, our study suggested that the presence of TMD pain cannot be explained by a simple linear model which takes psychological stress or SB into account. It also seems that psychological stress was a more important predictor factor for TMD pain than SB. © 2017 John Wiley & Sons Ltd.

Analysis of the contribution of experimental bias, experimental noise, and inter-subject biological variability on the assessment of developmental trajectories in diffusion MRI studies of the brain.

PubMed

Sadeghi, Neda; Nayak, Amritha; Walker, Lindsay; Okan Irfanoglu, M; Albert, Paul S; Pierpaoli, Carlo

2015-04-01

Metrics derived from the diffusion tensor, such as fractional anisotropy (FA) and mean diffusivity (MD) have been used in many studies of postnatal brain development. A common finding of previous studies is that these tensor-derived measures vary widely even in healthy populations. This variability can be due to inherent inter-individual biological differences as well as experimental noise. Moreover, when comparing different studies, additional variability can be introduced by different acquisition protocols. In this study we examined scans of 61 individuals (aged 4-22 years) from the NIH MRI study of normal brain development. Two scans were collected with different protocols (low and high resolution). Our goal was to separate the contributions of biological variability and experimental noise to the overall measured variance, as well as to assess potential systematic effects related to the use of different protocols. We analyzed FA and MD in seventeen regions of interest. We found that biological variability for both FA and MD varies widely across brain regions; biological variability is highest for FA in the lateral part of the splenium and body of the corpus callosum along with the cingulum and the superior longitudinal fasciculus, and for MD in the optic radiations and the lateral part of the splenium. These regions with high inter-individual biological variability are the most likely candidates for assessing genetic and environmental effects in the developing brain. With respect to protocol-related effects, the lower resolution acquisition resulted in higher MD and lower FA values for the majority of regions compared with the higher resolution protocol. However, the majority of the regions did not show any age-protocol interaction, indicating similar trajectories were obtained irrespective of the protocol used. Published by Elsevier Inc.

An Observational Study to Assess Brain MRI Change and Disease Progression in Multiple Sclerosis Clinical Practice-The MS-MRIUS Study.

PubMed

Zivadinov, Robert; Khan, Nasreen; Medin, Jennie; Christoffersen, Pia; Price, Jennifer; Korn, Jonathan R; Bonzani, Ian; Dwyer, Michael G; Bergsland, Niels; Carl, Ellen; Silva, Diego; Weinstock-Guttman, Bianca

2017-05-01

To describe methodology, interim baseline, and longitudinal magnetic resonance imaging (MRI) acquisition parameter characteristics of the multiple sclerosis clinical outcome and MRI in the United States (MS-MRIUS). The MS-MRIUS is an ongoing longitudinal and retrospective study of MS patients on fingolimod. Clinical and brain MRI image scan data were collected from 600 patients across 33 MS centers in the United States. MRI brain outcomes included change in whole-brain volume, lateral ventricle volume, T2- and T1-lesion volumes, and new/enlarging T2 and gadolinium-enhancing lesions. Interim baseline and longitudinal MRI acquisition parameters results are presented for 252 patients. Mean age was 44 years and 81% were female. Forty percent of scans had 3-dimensional (3D) T1 sequence in the preindex period, increasing to 50% in the postindex period. Use of 2-dimensional (2D) T1 sequence decreased over time from 85% in the preindex period to 65% in the postindex. About 95% of the scans with FLAIR and 2D T1-WI were considered acceptable or good quality compared to 99-100% with 3D T1-WI. There were notable changes in MRI hardware, software, and coil (39.5% in preindex to index and 50% in index to postindex). MRI sequence parameters (orientation, thickness, or protocol) differed for 36%, 29%, and 20% of index/postindex scans for FLAIR, 2D T1-WI, and 3D T1-WI, respectively. The MS-MRIUS study linked the clinical and brain MRI outcomes into an integrated database to create a cohort of fingolimod patients in real-world practice. Variability was observed in MRI acquisition protocols overtime. © 2016 The Authors. Journal of Neuroimaging published by Wiley Periodicals, Inc. on behalf of American Society of Neuroimaging.

Effects of the TCARE® intervention on caregiver burden and depressive symptoms: preliminary findings from a randomized controlled study.

PubMed

Montgomery, Rhonda J V; Kwak, Jung; Kosloski, Karl; O'Connell Valuch, Katharine

2011-09-01

We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden-objective, relationship, and stress burdens; depression; and intention for nursing home placement. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes.

Effects of the TCARE® Intervention on Caregiver Burden and Depressive Symptoms: Preliminary Findings From a Randomized Controlled Study

PubMed Central

Kwak, Jung; Kosloski, Karl; O’Connell Valuch, Katharine

2011-01-01

Objectives. We examined the effects of a manualized care management protocol specifically designed for care managers working with caregivers, the Tailored Caregiver Assessment and Referral® (TCARE®) protocol, on caregiver identity discrepancy, burden, and depressive symptoms. Methods. Preliminary data from a longitudinal, randomized, controlled intervention study with 266 family caregivers served by 52 care managers in 4 states were analyzed using repeated measures random effects regression procedures. Caregivers in the intervention and control groups were repeatedly assessed for up to 9 months on caregiver identity discrepancy, 3 areas of caregiving burden—objective, relationship, and stress burdens; depression; and intention for nursing home placement. Results. We found significant group by time interaction effects for caregiver identity discrepancy, relationship burden, stress burden, depression, and intention for nursing home placement. Caregivers in the intervention group experienced significant improvement on these measures, whereas caregivers in the control group worsened on these measures over time. Discussion. The preliminary findings provide strong support for effectiveness of the TCARE® protocol on improving caregiver well-being and mental health outcomes. PMID:21840840

Quality of life in stroke survivor-caregiver dyads: a new conceptual framework and longitudinal study protocol.

PubMed

Savini, Serenella; Buck, Harleah G; Dickson, Victoria Vaughan; Simeone, Silvio; Pucciarelli, Gianluca; Fida, Roberta; Matarese, Maria; Alvaro, Rosaria; Vellone, Ercole

2015-03-01

To describe a new conceptual framework and the research protocol of a study designed to examine the quality of life in stroke survivor-caregiver dyads. Stroke has a significant impact on the patient-caregiver dyad. Few studies have been guided by a specific conceptual framework which considers the interactions among pre-existing situations prior to stroke, the new situation caused by the stroke and the moderating effects of environmental and caregiver-related variables. Longitudinal study. A sample of stroke survivor-caregiver dyads will be enrolled at patient discharge from rehabilitation hospitals and will be surveyed every 3 months for 1-year. Hypotheses generated from the conceptual framework will test predictors, mediators and moderators of stroke survivor and caregiver quality of life from the pre-existing situation prior to the stroke, the new situation mediation poststroke and situation moderators. The study is supported by a grant from the Centre of Excellence for Nursing Scholarship, Rome, December 2013. This study seeks to identify variables in the pre-existing situation prior to the stroke (e.g. living condition), the new situation mediation poststroke (e.g. type of stroke and caregiver burden) as well as situation moderators (e.g. social support) that influence stroke survivor-caregiver dyad's quality of life across the stroke trajectory. Also, the study will inform clinical practice and research by identifying variables that are potentially modifiable and therefore amenable to intervention. The proposed framework will also be helpful for future research focused on stroke survivor-caregiver dyads. © 2014 John Wiley & Sons Ltd.

[Study protocol on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain].

PubMed

Pérez, Glòria; Gotsens, Mercè; Palència, Laia; Marí-Dell'Olmo, Marc; Domínguez-Berjón, M Felicitas; Rodríguez-Sanz, Maica; Puig, Vanessa; Bartoll, Xavier; Gandarillas, Ana; Martín, Unai; Bacigalupe, Amaia; Díez, Elia; Ruiz, Miguel; Esnaola, Santiago; Calvo, Montserrat; Sánchez, Pablo; Luque Fernández, Miguel Ángel; Borrell, Carme

The aim is to present the protocol of the two sub-studies on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain. Substudy 1: describe the evolution of mortality and reproductive health between 1990 and 2013 through a longitudinal ecological study in the Autonomous Communities. This study will identify changes caused by the economic crisis in trends or reproductive health and mortality indicators using panel data (17 Autonomous Communities per study year) and adjusting Poisson models with random effects variance. Substudy 2: analyse inequalities by socioeconomic deprivation in mortality and reproductive health in several areas of Spain. An ecological study analysing trends in the pre-crisis (1999-2003 and 2004-2008) and crisis (2009-2013) periods will be performed. Random effects models Besag York and Mollié will be adjusted to estimate mortality indicators softened in reproductive health and census tracts. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Multilingualism and fMRI: Longitudinal Study of Second Language Acquisition

PubMed Central

Andrews, Edna; Frigau, Luca; Voyvodic-Casabo, Clara; Voyvodic, James; Wright, John

2013-01-01

BOLD fMRI is often used for the study of human language. However, there are still very few attempts to conduct longitudinal fMRI studies in the study of language acquisition by measuring auditory comprehension and reading. The following paper is the first in a series concerning a unique longitudinal study devoted to the analysis of bi- and multilingual subjects who are: (1) already proficient in at least two languages; or (2) are acquiring Russian as a second/third language. The focus of the current analysis is to present data from the auditory sections of a set of three scans acquired from April, 2011 through April, 2012 on a five-person subject pool who are learning Russian during the study. All subjects were scanned using the same protocol for auditory comprehension on the same General Electric LX 3T Signa scanner in Duke University Hospital. Using a multivariate analysis of covariance (MANCOVA) for statistical analysis, proficiency measurements are shown to correlate significantly with scan results in the Russian conditions over time. The importance of both the left and right hemispheres in language processing is discussed. Special attention is devoted to the importance of contextualizing imaging data with corresponding behavioral and empirical testing data using a multivariate analysis of variance. This is the only study to date that includes: (1) longitudinal fMRI data with subject-based proficiency and behavioral data acquired in the same time frame; and (2) statistical modeling that demonstrates the importance of covariate language proficiency data for understanding imaging results of language acquisition. PMID:24961428

Multilingualism and fMRI: Longitudinal Study of Second Language Acquisition.

PubMed

Andrews, Edna; Frigau, Luca; Voyvodic-Casabo, Clara; Voyvodic, James; Wright, John

2013-05-28

BOLD fMRI is often used for the study of human language. However, there are still very few attempts to conduct longitudinal fMRI studies in the study of language acquisition by measuring auditory comprehension and reading. The following paper is the first in a series concerning a unique longitudinal study devoted to the analysis of bi- and multilingual subjects who are: (1) already proficient in at least two languages; or (2) are acquiring Russian as a second/third language. The focus of the current analysis is to present data from the auditory sections of a set of three scans acquired from April, 2011 through April, 2012 on a five-person subject pool who are learning Russian during the study. All subjects were scanned using the same protocol for auditory comprehension on the same General Electric LX 3T Signa scanner in Duke University Hospital. Using a multivariate analysis of covariance (MANCOVA) for statistical analysis, proficiency measurements are shown to correlate significantly with scan results in the Russian conditions over time. The importance of both the left and right hemispheres in language processing is discussed. Special attention is devoted to the importance of contextualizing imaging data with corresponding behavioral and empirical testing data using a multivariate analysis of variance. This is the only study to date that includes: (1) longitudinal fMRI data with subject-based proficiency and behavioral data acquired in the same time frame; and (2) statistical modeling that demonstrates the importance of covariate language proficiency data for understanding imaging results of language acquisition.

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.

Comparison of longitudinal excursion of a nerve-phantom model using quantitative ultrasound imaging and motion analysis system methods: A convergent validity study.

PubMed

Paquette, Philippe; El Khamlichi, Youssef; Lamontagne, Martin; Higgins, Johanne; Gagnon, Dany H

2017-08-01

Quantitative ultrasound imaging is gaining popularity in research and clinical settings to measure the neuromechanical properties of the peripheral nerves such as their capability to glide in response to body segment movement. Increasing evidence suggests that impaired median nerve longitudinal excursion is associated with carpal tunnel syndrome. To date, psychometric properties of longitudinal nerve excursion measurements using quantitative ultrasound imaging have not been extensively investigated. This study investigates the convergent validity of the longitudinal nerve excursion by comparing measures obtained using quantitative ultrasound imaging with those determined with a motion analysis system. A 38-cm long rigid nerve-phantom model was used to assess the longitudinal excursion in a laboratory environment. The nerve-phantom model, immersed in a 20-cm deep container filled with a gelatin-based solution, was moved 20 times using a linear forward and backward motion. Three light-emitting diodes were used to record nerve-phantom excursion with a motion analysis system, while a 5-cm linear transducer allowed simultaneous recording via ultrasound imaging. Both measurement techniques yielded excellent association ( r  = 0.99) and agreement (mean absolute difference between methods = 0.85 mm; mean relative difference between methods = 7.48 %). Small discrepancies were largely found when larger excursions (i.e. > 10 mm) were performed, revealing slight underestimation of the excursion by the ultrasound imaging analysis software. Quantitative ultrasound imaging is an accurate method to assess the longitudinal excursion of an in vitro nerve-phantom model and appears relevant for future research protocols investigating the neuromechanical properties of the peripheral nerves.

Longitudinal comparative evaluation of the equivalence of an integrated peer-support and clinical staffing model for residential mental health rehabilitation: a mixed methods protocol incorporating multiple stakeholder perspectives.

PubMed

Parker, Stephen; Dark, Frances; Newman, Ellie; Korman, Nicole; Meurk, Carla; Siskind, Dan; Harris, Meredith

2016-06-02

A novel staffing model integrating peer support workers and clinical staff within a unified team is being trialled at community based residential rehabilitation units in Australia. A mixed-methods protocol for the longitudinal evaluation of the outcomes, expectations and experiences of care by consumers and staff under this staffing model in two units will be compared to one unit operating a traditional clinical staffing. The study is unique with regards to the context, the longitudinal approach and consideration of multiple stakeholder perspectives. The longitudinal mixed methods design integrates a quantitative evaluation of the outcomes of care for consumers at three residential rehabilitation units with an applied qualitative research methodology. The quantitative component utilizes a prospective cohort design to explore whether equivalent outcomes are achieved through engagement at residential rehabilitation units operating integrated and clinical staffing models. Comparative data will be available from the time of admission, discharge and 12-month period post-discharge from the units. Additionally, retrospective data for the 12-month period prior to admission will be utilized to consider changes in functioning pre and post engagement with residential rehabilitation care. The primary outcome will be change in psychosocial functioning, assessed using the total score on the Health of the Nation Outcome Scales (HoNOS). Planned secondary outcomes will include changes in symptomatology, disability, recovery orientation, carer quality of life, emergency department presentations, psychiatric inpatient bed days, and psychological distress and wellbeing. Planned analyses will include: cohort description; hierarchical linear regression modelling of the predictors of change in HoNOS following CCU care; and descriptive comparisons of the costs associated with the two staffing models. The qualitative component utilizes a pragmatic approach to grounded theory, with collection of data from consumers and staff at multiple time points exploring their expectations, experiences and reflections on the care provided by these services. It is expected that the new knowledge gained through this study will guide the adaptation of these and similar services. For example, if differential outcomes are achieved for consumers under the integrated and clinical staffing models this may inform staffing guidelines.

A Perspective on a Possible Relation Between the Psychopathology of the Schizophrenia/Schizoaffective Spectrum and Unconjugated Bilirubin: A Longitudinal Protocol Study.

PubMed

Gama Marques, João; Arantes-Gonçalves, Filipe

2018-01-01

Some authors suggest a relation between Unconjugated Bilirubin (UCB) plasma high levels and schizophrenia, as schizophrenia patients have been showing higher UCB levels when compared with other psychiatric patients and general population. These higher UCB levels have been already correlated with acute psychotic states, positive symptoms, and poor outcome in patients with schizophrenia. Schizophrenia and schizoaffective disorders share common symptoms but there aren't yet accepted biomarkers for their distinction. In our study protocol we propose an observational longitudinal study on a sample composed of two subgroups: patients with schizophrenia and patients with schizoaffective disorder. We will compare the UCB levels between groups, and search for a possible correlation with patient's psychopathology. For that purpose we will use nosological, psychopathological, neuropsychological, and psychosocial instruments. Thus we will be testing two different hypotheses: (1) Is UCB serum level a diagnosis indicator, with categorical distinction potential, between groups of patients with different psychotic disorders? (2) Is UCB serum level a severity indicator, with dimensional distinction potential, among groups of patients with the same psychotic disorder? We believe that UCB mean levels may contribute to some clarification of this controversy, as a potential biological indicator, facilitating the distinction between these two diagnostic categories and\\or discriminating the dimensional severity among each of these psychotic conditions. Thus we may be opening a new opportunities for innovative and exciting biological psychiatry research regarding organic aspects in the schizophrenia spectrum.

A Perspective on a Possible Relation Between the Psychopathology of the Schizophrenia/Schizoaffective Spectrum and Unconjugated Bilirubin: A Longitudinal Protocol Study

PubMed Central

Gama Marques, João; Arantes-Gonçalves, Filipe

2018-01-01

Some authors suggest a relation between Unconjugated Bilirubin (UCB) plasma high levels and schizophrenia, as schizophrenia patients have been showing higher UCB levels when compared with other psychiatric patients and general population. These higher UCB levels have been already correlated with acute psychotic states, positive symptoms, and poor outcome in patients with schizophrenia. Schizophrenia and schizoaffective disorders share common symptoms but there aren't yet accepted biomarkers for their distinction. In our study protocol we propose an observational longitudinal study on a sample composed of two subgroups: patients with schizophrenia and patients with schizoaffective disorder. We will compare the UCB levels between groups, and search for a possible correlation with patient's psychopathology. For that purpose we will use nosological, psychopathological, neuropsychological, and psychosocial instruments. Thus we will be testing two different hypotheses: (1) Is UCB serum level a diagnosis indicator, with categorical distinction potential, between groups of patients with different psychotic disorders? (2) Is UCB serum level a severity indicator, with dimensional distinction potential, among groups of patients with the same psychotic disorder? We believe that UCB mean levels may contribute to some clarification of this controversy, as a potential biological indicator, facilitating the distinction between these two diagnostic categories and\\or discriminating the dimensional severity among each of these psychotic conditions. Thus we may be opening a new opportunities for innovative and exciting biological psychiatry research regarding organic aspects in the schizophrenia spectrum. PMID:29740357

Analysis of dental arch relationships in Swedish unilateral cleft lip and palate subjects: 20-year longitudinal consecutive series treated with delayed hard palate closure.

PubMed

Lilja, Jan; Mars, Michael; Elander, Anna; Enocson, Lars; Hagberg, Catharina; Worrell, Emma; Batra, Puneet; Friede, Hans

2006-09-01

To evaluate the dental arch relationships for a consecutive series from Goteborg, Sweden, who had delayed hard palate closure. Retrospective study. Sahlgrenska University Hospital, Goteborg, Sweden. The dental study models of 104 consecutive unilateral cleft lip and palate subjects. The study cohort was born between 1979 and 1994. Longitudinal records were available at ages 5 (n = 94), 10 (n = 97), 16 (n = 59), and 19 years (n = 46). Five assessors rated models according to the GOSLON Yardstick on two separate occasions each. These patients had been operated upon according to the Goteborg protocol of delayed hard palate closure (at age 8 years). 85% of subjects were rated in groups 1 and 2 (excellent or very good outcome), 12% were rated in group 3 (satisfactory), and 3% were assigned to group 4 (poor). No patients presented in Group 5 (very poor). Weighted kappa statistics for double determination of Yardstick allocation for five assessors demonstrated values between .65 and .90 for interrater agreement (good/very good) and between .70 and .90 for intrarater agreement (very good). Delayed hard palate closure as practiced in Goteborg since 1979 has produced the best GOSLON Yardstick ratings in a consecutive series of patients ever recorded worldwide, since the Yardstick was first used in 1983. However, it is noteworthy that a new protocol has been introduced in Goteborg since 1994, in which hard palate closure is done at 3 years due to concerns regarding speech.

Obese parents--obese children? Psychological-psychiatric risk factors of parental behavior and experience for the development of obesity in children aged 0-3: study protocol.

PubMed

Grube, Matthias; Bergmann, Sarah; Keitel, Anja; Herfurth-Majstorovic, Katharina; Wendt, Verena; von Klitzing, Kai; Klein, Annette M

2013-12-17

The incidences of childhood overweight and obesity have increased substantially and with them the prevalence of associated somatic and psychiatric health problems. Therefore, it is important to identify modifiable risk factors for early childhood overweight in order to develop effective prevention or intervention programs. Besides biological factors, familial interactions and parental behavioral patterns may influence children's weight development. Longitudinal investigation of children at overweight risk could help to detect significant risk and protective factors. We aim to describe infants' weight development over time and identify risk and protective factors for the incidence of childhood obesity. Based on our findings we will draw up a risk model that will lay the foundation for an intervention/prevention program. We present the protocol of a prospective longitudinal study in which we investigate families with children aged from 6 months to 47 months. In half of the families at least one parent is obese (risk group), in the other half both parents are normal weight (control group). Based on developmental and health-psychological models, we consider measurements at three levels: the child, the parents and parent-child-relationship. Three assessment points are approximately one year apart. At each assessment point we evaluate the psychological, social, and behavioral situation of the parents as well as the physical and psychosocial development of the child. Parents are interviewed, fill in questionnaires, and take part in standardized interaction tasks with their child in a feeding and in a playing context in our research laboratory. The quality of these video-taped parent-child interactions is assessed by analyzing them with standardized, validated instruments according to scientific standards. Strengths of the presented study are the prospective longitudinal design, the multi-informant approach, including the fathers, and the observation of parent-child interaction. A limitation is the variation in children's age.

Obese parents – obese children? Psychological-psychiatric risk factors of parental behavior and experience for the development of obesity in children aged 0–3: study protocol

PubMed Central

2013-01-01

Background The incidences of childhood overweight and obesity have increased substantially and with them the prevalence of associated somatic and psychiatric health problems. Therefore, it is important to identify modifiable risk factors for early childhood overweight in order to develop effective prevention or intervention programs. Besides biological factors, familial interactions and parental behavioral patterns may influence children’s weight development. Longitudinal investigation of children at overweight risk could help to detect significant risk and protective factors. We aim to describe infants’ weight development over time and identify risk and protective factors for the incidence of childhood obesity. Based on our findings we will draw up a risk model that will lay the foundation for an intervention/prevention program. Methods/Design We present the protocol of a prospective longitudinal study in which we investigate families with children aged from 6 months to 47 months. In half of the families at least one parent is obese (risk group), in the other half both parents are normal weight (control group). Based on developmental and health-psychological models, we consider measurements at three levels: the child, the parents and parent–child-relationship. Three assessment points are approximately one year apart. At each assessment point we evaluate the psychological, social, and behavioral situation of the parents as well as the physical and psychosocial development of the child. Parents are interviewed, fill in questionnaires, and take part in standardized interaction tasks with their child in a feeding and in a playing context in our research laboratory. The quality of these video-taped parent–child interactions is assessed by analyzing them with standardized, validated instruments according to scientific standards. Discussion Strengths of the presented study are the prospective longitudinal design, the multi-informant approach, including the fathers, and the observation of parent–child interaction. A limitation is the variation in children’s age. PMID:24341703

The aging physician and surgeon.

PubMed

Sataloff, Robert T; Hawkshaw, Mary; Kutinsky, Joshua; Maitz, Edward A

2016-01-01

As the population of aging physicians increases, methods of assessing physicians' cognitive function and predicting clinically significant changes in clinical performance become increasingly important. Although several approaches have been suggested, no evaluation system is accepted or utilized widely. This article reviews literature using MEDLINE, PubMed, and other sources. Articles discussing the problems of geriatric physicians are summarized, stressing publications that proposed methods of evaluation. Selected literature on evaluating aging pilots also was reviewed, and potential applications for physician evaluation are proposed. Neuropsychological cognitive test protocols were summarized, and a reduced evaluation protocol is proposed for interdisciplinary longitudinal research. Although there are several articles evaluating cognitive function in aging physicians and aging pilots, and although a few institutions have instituted cognitive evaluation, there are no longitudinal data assessing cognitive function in physicians over time or correlating them with performance. Valid, reliable testing of cognitive function of physicians is needed. In order to understand its predictive value, physicians should be tested over time starting when they are young, and results should be correlated with physician performance. Early testing is needed to determine whether cognitive deficits are age-related or long-standing. A multi-institutional study over many years is proposed. Additional assessments of other factors such as manual dexterity (perhaps using simulators) and physician frailty are recommended.

The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study.

PubMed

Claes, Annes J; Mertens, Griet; Gilles, Annick; Hofkens-Van den Brandt, Anouk; Fransen, Erik; Van Rompaey, Vincent; Van de Heyning, Paul

2016-01-01

Background: Currently, an independent relationship between hearing loss and cognitive decline in older adults is suggested by large prospective studies. In general, cochlear implants improve hearing and the quality of life in severely to profoundly hearing impaired older persons. However, little is known about the effects of cochlear implantation on the cognitive evolution in this population. Aim of the study: The primary goal of this prospective, longitudinal cohort study is to explore the cognitive profile of severely to profoundly postlingually hearing impaired subjects before and after cochlear implantation. In addition, the current study aims to investigate the relationship between the cognitive function, audiometric performances, quality of life, and self-reliance in these patients. Methods: Twenty-five patients aged 55 or older, scheduled for cochlear implantation, will be enrolled in the study. They will be examined prior to implantation, at 6 and 12 months after implantation and annually thereafter. The test battery consists of (1) a cognitive examination, using the Repeatable Battery for the Assessment of Neuropsychological Status adapted for Hearing impaired persons (RBANS-H), (2) an audiological examination, including unaided and aided pure tone audiometry, speech audiometry in quiet and speech audiometry in noise, (3) the administration of four questionnaires evaluating quality of life and subjective hearing benefit and (4) a semi-structured interview about the self-reliance of the participant. Discussion: Up until now only one study has been conducted on this topic, focusing on the short-term effects of cochlear implantation on cognition in older adults. The present study is the first study to apply a comprehensive neuropsychological assessment adapted for severely to profoundly hearing impaired subjects in order to investigate the cognitive capabilities before and after cochlear implantation. Trial registration: The present protocol is retrospectively registered at Clinical Trials (ClinicalTrials.gov) on June 9th, 2016. The first participant was enrolled on June 22nd, 2015. The protocol identifier is NCT02794350.

The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study

PubMed Central

Claes, Annes J.; Mertens, Griet; Gilles, Annick; Hofkens-Van den Brandt, Anouk; Fransen, Erik; Van Rompaey, Vincent; Van de Heyning, Paul

2016-01-01

Background: Currently, an independent relationship between hearing loss and cognitive decline in older adults is suggested by large prospective studies. In general, cochlear implants improve hearing and the quality of life in severely to profoundly hearing impaired older persons. However, little is known about the effects of cochlear implantation on the cognitive evolution in this population. Aim of the study: The primary goal of this prospective, longitudinal cohort study is to explore the cognitive profile of severely to profoundly postlingually hearing impaired subjects before and after cochlear implantation. In addition, the current study aims to investigate the relationship between the cognitive function, audiometric performances, quality of life, and self-reliance in these patients. Methods: Twenty-five patients aged 55 or older, scheduled for cochlear implantation, will be enrolled in the study. They will be examined prior to implantation, at 6 and 12 months after implantation and annually thereafter. The test battery consists of (1) a cognitive examination, using the Repeatable Battery for the Assessment of Neuropsychological Status adapted for Hearing impaired persons (RBANS-H), (2) an audiological examination, including unaided and aided pure tone audiometry, speech audiometry in quiet and speech audiometry in noise, (3) the administration of four questionnaires evaluating quality of life and subjective hearing benefit and (4) a semi-structured interview about the self-reliance of the participant. Discussion: Up until now only one study has been conducted on this topic, focusing on the short-term effects of cochlear implantation on cognition in older adults. The present study is the first study to apply a comprehensive neuropsychological assessment adapted for severely to profoundly hearing impaired subjects in order to investigate the cognitive capabilities before and after cochlear implantation. Trial registration: The present protocol is retrospectively registered at Clinical Trials (ClinicalTrials.gov) on June 9th, 2016. The first participant was enrolled on June 22nd, 2015. The protocol identifier is NCT02794350. PMID:27895549

Testing the effectivity of the mixed virtual reality training Into D'mentia for informal caregivers of people with dementia: protocol for a longitudinal, quasi-experimental study.

PubMed

Jütten, Linda Helena; Mark, Ruth Elaine; Maria Janssen, Ben Wilhelmus Jacobus; Rietsema, Jan; Dröes, Rose-Marie; Sitskoorn, Margriet Maria

2017-08-21

Informal caregivers for people with dementia (hereafter: caregivers) often feel (over)burdened by the care for a loved one with dementia, and this can have various deleterious effects on both caregivers and patients. Support for caregivers is urgently needed, and for this reason, a dementia simulator (Into D'mentia) was developed in which caregivers experience what it is like to have dementia. The simulator attempts to heighten caregivers' empathy and understanding for the patient and, in turn, diminish their own caregiver burden. The current study evaluates whether the simulator is effective on a number of outcomes. A longitudinal, quasi-experimental study is ongoing in the Netherlands. We aim to recruit 142 caregivers in total divided over two groups: 71 caregivers in the intervention group and 71 caregivers in the control group. All participants will complete interviews and questionnaires at four time points: at baseline, 1 week, 2.5 months and 15 months after the training. The primary outcomes include empathy, caregiver burden, caregiver's sense of competence, social reliance, anxiety, depression and caregivers' subjective and objective health. This study is being carried out in agreement with the Declaration of Helsinki, and the protocol has been approved by the local ethics committees. This study is registered with The Netherlands National Trial Register (NNTR5856). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

An extended protocol for usability validation of medical devices: Research design and reference model.

PubMed

Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten

2017-05-01

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a prevailing focus on cross-sectional validation studies, ignoring the issues of learnability and training. The U.S. Federal Drug and Food Administration's recent proposal for a validation testing protocol for medical devices is then extended to address these shortcomings: (1) a novel process measure 'normative path deviations' is introduced that is useful for both quantitative and qualitative usability studies and (2) a longitudinal, completely within-subject study design is presented that assesses learnability, training effects and allows analysis of diversity of users. A reference regression model is introduced to analyze data from this and similar studies, drawing upon generalized linear mixed-effects models and a Bayesian estimation approach. The extended protocol is implemented and demonstrated in a study comparing a novel syringe infusion pump prototype to an existing design with a sample of 25 healthcare professionals. Strong performance differences between designs were observed with a variety of usability measures, as well as varying training-on-the-job effects. We discuss our findings with regard to validation testing guidelines, reflect on the extensions and discuss the perspectives they add to the validation process. Copyright © 2017 Elsevier Inc. All rights reserved.

Longitudinal qualitative exploration of cancer information-seeking experiences across the disease trajectory: the INFO-SEEK protocol.

PubMed

Germeni, Evi; Bianchi, Monica; Valcarenghi, Dario; Schulz, Peter J

2015-10-06

Α substantial corpus of literature has sought to describe the information-seeking behaviour of patients with cancer. Yet, available evidence comes mainly from cross-sectional studies, which provide 'snapshots' of patients' information needs and information-seeking styles at a single time point. Only a few longitudinal studies currently exist; however, these are quantitative in nature and, despite successfully documenting changes in patients' information needs throughout the clinical course of cancer, they have failed to provide an evidence-based interpretation of the causes and consequences of change. The goal of this study is threefold: First, we wish to provide a holistic understanding of how cancer information-seeking behaviour may evolve across different stages of the patient journey. Second, we will seek to elucidate the contextual and intervening conditions that may affect possible changes in information seeking. Third, we will attempt to identify what the consequences of these changes are, while heightening their implications for clinical practice and policy. We will carry out a longitudinal qualitative study, based on face-to-face, in-depth interviews with approximately 25 individuals diagnosed with cancer. Patients will be recruited from 2 oncology hospitals located in Ticino, Switzerland, and will be interviewed at 3 different time points: (1) within 2 weeks after receiving the cancer diagnosis; (2) within 2 weeks after their initial treatment; and (3) 6 months after their initial treatment. All interviews will be recorded and transcribed verbatim. A grounded theory approach will be used for the analysis of the data. The study protocol has been approved by the Ethics Committee of Canton Ticino (CE 2813). Participation in the study will be voluntary, and confidentiality and anonymity ensured. Prior to study participation, patients will be asked to provide signed informed consent. Findings will be disseminated in international peer-reviewed journals and presented in relevant conferences. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Quantitative echocardiographic measures in the assessment of single ventricle function post-Fontan: Incorporation into routine clinical practice.

PubMed

Rios, Rodrigo; Ginde, Salil; Saudek, David; Loomba, Rohit S; Stelter, Jessica; Frommelt, Peter

2017-01-01

Quantitative echocardiographic measurements of single ventricular (SV) function have not been incorporated into routine clinical practice. A clinical protocol, which included quantitative measurements of SV deformation (global circumferential and longitudinal strain and strain rate), standard deviation of time to peak systolic strain, myocardial performance index (MPI), dP/dT from an atrioventricular valve regurgitant jet, and superior mesenteric artery resistance index, was instituted for all patients with a history of Fontan procedure undergoing echocardiography. All measures were performed real time during clinically indicated studies and were included in clinical reports. A total of 100 consecutive patients (mean age = 11.95±6.8 years, range 17 months-31.3 years) completed the protocol between September 1, 2014 to April 29, 2015. Deformation measures were completed in 100% of the studies, MPI in 93%, dP/dT in 55%, and superior mesenteric artery Doppler in 82%. The studies were reviewed to assess for efficiency in completing the protocol. The average time for image acquisition was 27.4±8.8 (range 10-62 minutes). The average time to perform deformation measures was 10.8±5.5 minutes (range 5-35 minutes) and time from beginning of imaging to report completion was 53.4±13.7 minutes (range 27-107 minutes). There was excellent inter-observer reliability when deformation indices were blindly repeated. Patients with a single left ventricle had significantly higher circumferential strain and strain rate, longitudinal strain and strain rate, and dP/dT compared to a single right ventricle. There were no differences in quantitative indices of ventricular function between patients <10 vs. >10 years post-Fontan. Advanced quantitative assessment of SV function post-Fontan can be consistently and efficiently performed real time during clinically indicated echocardiograms with excellent reliability. © 2016, Wiley Periodicals, Inc.

A Military-Relevant Model of Closed Concussive Head Injury: Longitudinal Studies Characterizing and Validating Single and Repetitive mTBI

DTIC Science & Technology

2013-10-01

processed at FD Neurotechnologies Inc. (Ellicott City, MD, USA). A series of coronal free floating brain sections (40 μm; 960 µm interval from +4.0...axonal damage. Another series of coronal sections was stained using FD NeuroSilverTM Kit II (FD Neurotechnologies Inc., Ellicott City, MD, USA) for... Neurotechnologies Inc for processing and staining. Tissue processing and staining protocols have been optimized for fluorescent staining of AQ4 co

Emerging Therapeutic Strategies and Future Challenges in Clinical Periodontics.

PubMed

Shin, Daniel; Hamada, Yusuke; John, Vanchit

2016-01-01

Currently, the protocol for treating periodontitis follows a standardized and straightforward algorithm: 1) review and reinforce oral hygiene; 2) perform scaling and root planing; 3) proceed to periodontal surgery if the disease process has not been arrested; then 4) enroll the patient in a customized periodontal maintenance recall program to maintain the health of the reduced periodontium. Multiple longitudinal studies have demonstrated that the aforementioned treatment regimen can arrest the progression of periodontitis and can increase the likelihood of tooth retention and periodontal stability.

Estimating gestational age at birth from fundal height and additional anthropometrics: a prospective cohort study.

PubMed

Pugh, S J; Ortega-Villa, A M; Grobman, W; Newman, R B; Owen, J; Wing, D A; Albert, P S; Grantz, K L

2018-02-23

Accurate assessment of gestational age (GA) is critical to paediatric care, but is limited in developing countries without access to ultrasound. Our objectives were to assess the accuracy of prediction of GA at birth and preterm birth classification using routinely collected anthropometry measures. Prospective cohort study. United States. A total of 2334 non-obese and 468 obese pregnant women. Enrolment GA was determined based on last menstrual period, confirmed by first-trimester ultrasound. Maternal anthropometry and fundal height (FH) were measured by a standardised protocol at study visits; FH alone was additionally abstracted from medical charts. Neonatal anthropometry measurements were obtained at birth. To estimate GA at delivery, we developed three predictor models using longitudinal FH alone and with maternal and neonatal anthropometry. For all predictors, we repeatedly sampled observations to construct training (60%) and test (40%) sets. Linear mixed models incorporated longitudinal maternal anthropometry and a shared parameter model incorporated neonatal anthropometry. We assessed models' accuracy under varied scenarios. Estimated GA at delivery. Prediction error for various combinations of anthropometric measures ranged between 13.9 and 14.9 days. Longitudinal FH alone predicted GA within 14.9 days with relatively stable prediction errors across individual race/ethnicities [whites (13.9 days), blacks (15.1 days), Hispanics (15.5 days) and Asians (13.1 days)], and correctly identified 75% of preterm births. The model was robust to additional scenarios. In low-risk, non-obese women, longitudinal FH measures alone can provide a reasonably accurate assessment of GA when ultrasound measures are not available. Longitudinal fundal height alone predicts gestational age at birth when ultrasound measures are unavailable. © 2018 Royal College of Obstetricians and Gynaecologists.

A longitudinal study of urea cycle disorders.

PubMed

Batshaw, Mark L; Tuchman, Mendel; Summar, Marshall; Seminara, Jennifer

2014-01-01

The Urea Cycle Disorders Consortium (UCDC) is a member of the NIH funded Rare Diseases Clinical Research Network and is performing a longitudinal study of 8 urea cycle disorders (UCDs) with initial enrollment beginning in 2006. The consortium consists of 14 sites in the U.S., Canada and Europe. This report summarizes data mining studies of 614 patients with UCDs enrolled in the UCDC's longitudinal study protocol. The most common disorder is ornithine transcarbamylase deficiency, accounting for more than half of the participants. We calculated the overall prevalence of urea cycle disorders to be 1/35,000, with 2/3rds presenting initial symptoms after the newborn period. We found the mortality rate to be 24% in neonatal onset cases and 11% in late onset cases. The most common precipitant of clinical hyperammonemic episodes in the post-neonatal period was intercurrent infections. Elevations in both blood ammonia and glutamine appeared to be biomarkers for neurocognitive outcome. In terms of chronic treatment, low protein diet appeared to result in normal weight but decreased linear growth while N-scavenger therapy with phenylbutyrate resulted in low levels of branched chain amino acids. Finally, we found an unexpectedly high risk for hepatic dysfunction in patients with ornithine transcarbamylase deficiency. This natural history study illustrates how a collaborative study of a rare genetic disorder can result in an improved understanding of morbidity and disease outcome. Copyright © 2014 Elsevier Inc. All rights reserved.

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

Samet, J.; Gilliland, F.D.

This project incorporates two related research projects directed toward understanding respiratory carcinogenesis in radon-exposed former uranium miners. The first project involved a continuation of the tissue resource of lung cancer cases from former underground uranium miners and comparison cases from non-miners. The second project was a pilot study for a proposed longitudinal study of respiratory carcinogenesis in former uranium miners. The objectives including facilitating the investigation of molecular changes in radon exposed lung cancer cases, developing methods for prospectively studying clinical, cytologic, cytogenetic, and molecular changes in the multi-event process of respiratory carcinogenesis, and assessing the feasibility of recruiting formermore » uranium miners into a longitudinal study that collected multiple biological specimens. A pilot study was conducted to determine whether blood collection, induced sputum, bronchial brushing, washings, and mucosal biopsies from participants at two of the hospitals could be included efficiently. A questionnaire was developed for the extended study and all protocols for specimen collection and tissue handling were completed. Resource utilization is in progress at ITRI and the methods have been developed to study molecular and cellular changes in exfoliated cells contained in sputum as well as susceptibility factors.« less

Language ability of children with and without a history of stuttering: a longitudinal cohort study.

PubMed

Watts, Amy; Eadie, Patricia; Block, Susan; Mensah, Fiona; Reilly, Sheena

2015-02-01

This study aims to determine whether the communication and language skills of children who have a history of stuttering are different from children who do not have a history of stuttering at ages 2-5 years. This study utilizes data from the Early Language in Victoria Study (ELVS), a longitudinal study with a community sample of 1910 children recruited in Melbourne, Australia, as well as a concurrent study examining the onset and progression of stuttering. Participants with a history of stuttering (n = 181) and a control group without a history of stuttering (n = 1438) were identified according to the established protocol of these two existing studies. The stuttering group scored higher than the non-stuttering group on all of the communication and language outcomes measured. The group differences were statistically significant on four of the seven measures and these findings were maintained when potentially confounding factors were controlled for. Importantly, the children with a history of stuttering, as a group, and the control group without a history of stuttering demonstrated developmentally-appropriate early communication and language skills.

Longitudinal social networks impacts on weight and weight-related behaviors assessed using mobile-based ecological momentary assessments: Study Protocols for the SPARC study.

PubMed

Bruening, Meg; Ohri-Vachaspati, Punam; Brewis, Alexandra; Laska, Melissa; Todd, Michael; Hruschka, Daniel; Schaefer, David R; Whisner, Corrie M; Dunton, Genevieve

2016-08-30

The transition from the home to college is a phase in which emerging adults shift toward more unhealthy eating and physical activity patterns, higher body mass indices, thus increasing risk of overweight/obesity. Currently, little is understood about how changing friendship networks shape weight gain behaviors. This paper describes the recruitment, data collection, and data analytic protocols for the SPARC (Social impact of Physical Activity and nutRition in College) study, a longitudinal examination of the mechanisms by which friends and friendship networks influence nutrition and physical activity behaviors and weight gain in the transition to college life. The SPARC study aims to follow 1450 university freshmen from a large university over an academic year, collecting data on multiple aspects of friends and friendship networks. Integrating multiple types of data related to student lives, ecological momentary assessments (EMAs) are administered via a cell phone application, devilSPARC. EMAs collected in four 1-week periods (a total of 4 EMA waves) are integrated with linked data from web-based surveys and anthropometric measurements conducted at four times points (for a total of eight data collection periods including EMAs, separated by ~1 month). University databases will provide student card data, allowing integration of both time-dated data on food purchasing, use of physical activity venues, and geographical information system (GIS) locations of these activities relative to other students in their social networks. Findings are intended to guide the development of more effective interventions to enhance behaviors among college students that protect against weight gain during college.

A methodology for assessing deployment trauma and its consequences in OEF/OIF/OND veterans: The TRACTS longitudinal prospective cohort study

PubMed Central

McGlinchey, Regina E.; Milberg, William P.; Fonda, Jennifer R.; Fortier, Catherine Brawn

2017-01-01

Many US veterans of Afghanistan and Iraq have multiple physical and psychiatric problems. A major focus of research has been on determining the effects of mild Traumatic Brain Injury (mTBI), but mTBI is rarely diagnosed in the absence of co-occurring conditions such as blast exposure, post-traumatic stress disorder (PTSD), depression, substance abuse, etc. These potentially interactive psychological and physical conditions produce complex patterns of cognitive, psychological, and physical symptoms that impede civilian reintegration and complicate efficient and effective treatment planning. The Translational Research Center for TBI and Stress Disorders (TRACTS) has developed a multidisciplinary approach to the assessment of deployment trauma and its consequences in veterans of these wars. The prospective TRACTS longitudinal cohort study conducts state-of-the-art assessments in the domains of biomedical function, lifetime head trauma, psychological function encompassing deployment experience and lifetime exposure to traumatic events, neuropsychological function, and structural and functional neuroimaging. The TRACTS longitudinal cohort study is the first of its kind to comprehensively evaluate lifetime incidence of TBI and PTSD in these veterans, in addition to those incurred during military deployment. The protocol has begun to reveal information that will help improve understanding of the complex pathophysiology associated with co-occurring mTBI and related stress disorders. PMID:28211592

Simple Perfusion Apparatus (SPA) for Manipulation, Tracking and Study of Oocytes and Embryos

PubMed Central

Angione, Stephanie L.; Oulhen, Nathalie; Brayboy, Lynae M.; Tripathi, Anubhav; Wessel, Gary M.

2016-01-01

Objective To develop and implement a device and protocol for oocyte analysis at a single cell level. The device must be capable of high resolution imaging, temperature control, perfusion of media, drugs, sperm, and immunolabeling reagents all at defined flow-rates. Each oocyte and resultant embryo must remain spatially separated and defined. Design Experimental laboratory study Setting University and Academic Center for reproductive medicine. Patients/Animals Women with eggs retrieved for ICSI cycles, adult female FVBN and B6C3F1 mouse strains, sea stars. Intervention Real-time, longitudinal imaging of oocytes following fluorescent labeling, insemination, and viability tests. Main outcome measure(s) Cell and embryo viability, immunolabeling efficiency, live cell endocytosis quantitation, precise metrics of fertilization and embryonic development. Results Single oocytes were longitudinally imaged following significant changes in media, markers, endocytosis quantitation, and development, all with supreme control by microfluidics. Cells remained viable, enclosed, and separate for precision measurements, repeatability, and imaging. Conclusions We engineered a simple device to load, visualize, experiment, and effectively record individual oocytes and embryos, without loss of cells. Prolonged incubation capabilities provide longitudinal studies without need for transfer and potential loss of cells. This simple perfusion apparatus (SPA) provides for careful, precise, and flexible handling of precious samples facilitating clinical in vitro fertilization approaches. PMID:25450296

Effectiveness and Value of Prophylactic 5-Layer Foam Sacral Dressings to Prevent Hospital-Acquired Pressure Injuries in Acute Care Hospitals

PubMed Central

2017-01-01

PURPOSE: The purpose of this study was to examine the effectiveness and value of prophylactic 5-layer foam sacral dressings to prevent hospital-acquired pressure injury rates in acute care settings. DESIGN: Retrospective observational cohort. SAMPLE AND SETTING: We reviewed records of adult patients 18 years or older who were hospitalized at least 5 days across 38 acute care hospitals of the University Health System Consortium (UHC) and had a pressure injury as identified by Patient Safety Indicator #3 (PSI-03). All facilities are located in the United States. METHODS: We collected longitudinal data pertaining to prophylactic 5-layer foam sacral dressings purchased by hospital-quarter for 38 academic medical centers between 2010 and 2015. Longitudinal data on acute care, hospital-level patient outcomes (eg, admissions and PSI-03 and pressure injury rate) were queried through the UHC clinical database/resource manager from the Johns Hopkins Medicine portal. Data on volumes of dressings purchased per UHC hospital were merged with UHC data. Mixed-effects negative binomial regression was used to test the longitudinal association of prophylactic foam sacral dressings on pressure injury rates, adjusted for hospital case-mix and Medicare payments rules. RESULTS: Significant pressure injury rate reductions in US acute care hospitals between 2010 and 2015 were associated with the adoption of prophylactic 5-layer foam sacral dressings within a prevention protocol (−1.0 cases/quarter; P = .002) and changes to Medicare payment rules in 2014 (−1.13 cases/quarter; P = .035). CONCLUSIONS: Prophylactic 5-layer foam sacral dressings are an effective component of a pressure injury prevention protocol. Hospitals adopting these technologies should expect good value for use of these products. PMID:28816929

A study protocol for tracking quality of life among U.S. service members wounded in Iraq and Afghanistan: the Wounded Warrior Recovery Project.

PubMed

Woodruff, Susan I; Galarneau, Michael R; Luu, Bethi N; Sack, Daniel; Han, Peggy

2014-03-01

There is a need for more work to understand the quality of life (QOL) outcomes of survivors of Operations Enduring Freedom and Iraqi Freedom combat injury to improve care and treatment, and prevent poor physical, psychological, and social outcomes. We describe the study design and methods of the Wounded Warrior Recovery Project, a study supported by the Department of Defense that will track close to 10,000 military personnel wounded in Operations Enduring Freedom and Iraqi Freedom. The overall objective of the 6-year longitudinal study is to track changes in QOL and describe variations in those changes as they relate to sociodemographic factors, injury characteristics, service-related factors, clinical/diagnostic measures including traumatic brain injury and posttraumatic stress disorder, and medical procedures and services. The Wounded Warrior Recovery Project study will be among the first longitudinal population-based investigations of QOL outcomes after combat injury and will provide a basis upon which large-scale epidemiological studies can be conducted. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

Distribution of Parvovirus B19 DNA in Blood Compartments and Persistence of Virus in Blood Donors

PubMed Central

Lee, Tzong-Hae; Kleinman, Steven H.; Wen, Li; Montalvo, Lani; Todd, Deborah S.; Wright, David J.; Tobler, Leslie H.; Busch, Michael P.

2013-01-01

Introduction Because the receptor for Parvovirus B19 (B19V) is on erythrocytes, we investigated B19V distribution in blood by in-vitro spiking experiments and evaluated viral compartmentalization and persistence in natural infection. Methods Two whole blood protocols (ultracentrifugation and a rapid RBC lysis/removal protocol) were evaluated using quantitative real-time PCR. Whole blood (WB) was spiked with known concentrations of B19V and recovery in various blood fractions was determined. The rapid RBC lysis/removal protocol was then used to compare B19V concentrations in 104 paired whole blood and plasma samples collected longitudinally from 43 B19V infected donors with frozen specimens in the REDS Allogeneic Donor and Recipient Repository (RADAR). Results In B19V spiking experiments, ~one-third of viral DNA was recovered in plasma and two-thirds was loosely bound to erythrocytes. In the IgM positive stage of infection in blood donors when plasma B19V DNA concentrations were > 100 IU/mL, median DNA concentrations were ~30-fold higher in WB than in plasma. In contrast, when IgM was absent and when the B19V DNA concentration was lower, the median whole blood to plasma ratio was ~1. Analysis of longitudinal samples demonstrated persistent detection of B19V in WB but declining ratios of WB/plasma B19V with declining plasma VL levels and loss of IgM-reactivity. Conclusions The WB/plasma B19V DNA ratio varies by stage of infection. Further study is required to determine if this is related to the presence of circulating DNA-positive erythrocytes derived from B19V infected erythroblasts, B19V-specific IgM mediated binding of virus to cells, or other factors. PMID:21303368

Association between post-game recovery protocols, physical and perceived recovery, and performance in elite Australian Football League players.

PubMed

Bahnert, Andrew; Norton, Kevin; Lock, Phillip

2013-03-01

To determine the associations between post-game recovery protocols and physical and perceptual recovery, and game performance in Australian Football League players. A longitudinal quasi-experimental study design was used across a season. A full squad of 44 footballers was monitored weekly across a 23-game season. Players were required to choose from a number of recovery modalities available immediately post-game. These included floor stretching, pool stretching, bike active recovery, pool active recovery, cold-water immersion, contrast therapy and use of a compression garment. Perceptual measures of recovery were recorded throughout the week and a test of physical performance was conducted two days post-game. Game performance ratings were also recorded. The associations between the post-game recovery protocols chosen and players' perceived recovery, and physical and game performances were determined by the association rule data-mining strategy. Statistically significant associations were found between a number of post-game recovery protocols and perceptual recovery. In general, players who chose cold-water immersion, floor stretching, no active recovery (neither bike or pool) and the use of a compression garment post-game, had an increased probability of reporting greater perceptual recovery across the following week, relative to all other permutations of recovery protocols chosen. There were no associations found between post-game recovery protocol combinations and physical recovery. No associations were found between the post-game recovery methods and the next game performance. Perceptual recovery among players was enhanced through the selection of specific combinations of recovery protocols post game. However, no links were found between recovery protocols and physical or game performance measures. Copyright © 2012 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Feasibility and Acceptability of Adapting the Eating in the Absence of Hunger Assessment for Preschoolers in the Classroom Setting

PubMed Central

Soltero, Erica G.; Ledoux, Tracey; Lee, Rebecca E.

2015-01-01

Eating in the Absence of Hunger (EAH) represents a failure to self-regulate intake leading to overconsumption. Existing research on EAH has come from the clinical setting, limiting our understanding of this behavior. The purpose of this study was to describe the adaptation of the clinical EAH paradigm for preschoolers to the classroom setting and evaluate the feasibility and acceptability of measuring EAH in the classroom. The adapted protocol was implemented in childcare centers in Houston, Texas (N=4) and Phoenix, Arizona (N=2). The protocol was feasible, economical, and time efficient, eliminating previously identified barriers to administering the EAH assessment such as limited resources and the time constraint of delivering the assessment to participants individually. Implementation challenges included difficulty in choosing palatable test snacks that were in compliance with childcare center food regulations and the limited control over the meal that was administered prior to the assessment. The adapted protocol will allow for broader use of the EAH assessment and encourage researchers to incorporate the assessment into longitudinal studies in order to further our understanding of the causes and emergence of EAH. PMID:26172567

Multidetector computed tomographic morphology of ovaries in cynomolgus macaques (Macaca fascicularis).

PubMed

Jones, Jeryl C; Appt, Susan E; Bourland, J Daniel; Hoyer, Patricia B; Clarkson, Thomas B; Kaplan, Jay R

2007-09-01

Macaques are important models for menopause and associated diseases in women. A sensitive, noninvasive technique for quantifying changes in ovarian morphology would facilitate longitudinal studies focused on the health-related sequelae of naturally occurring or experimentally induced alterations in ovarian structure and function. Multidetector computed tomography (MDCT) is a fast, non-invasive imaging technique that uses X-rays, multiple rows of detectors, and computers to generate detailed slice images of structures. The purpose of this study was to describe the utility of MDCT for reliably characterizing ovarian morphology in macaques. Five macaques were scanned using contrast-enhanced MDCT. The following characteristics were described: 1) appearance of ovaries and adjacent landmarks, 2) effects of varying technical protocols on ovarian image quality, 3) radiation doses delivered to the pelvic region during scanning, and 4) MDCT estimates of ovarian volume and antral follicle counts versus those measured directly in ovarian tissue. Ovaries were distinguishable in all MDCT scans and exhibited heterogeneous contrast enhancement. Antral follicles appeared as focal areas of nonenhancement. Ovarian image quality with 5 pediatric scanning protocols was sufficient for discriminating ovarian margins. Pelvic region radiation doses ranged from 0.5 to 0.7 rad. Antral follicles counted using MDCT ranged from 3 to 5 compared with 3 to 4 counted using histology. Ovarian volumes measured using MDCT ranged from 0.41 to 0.67 ml compared with 0.40 to 0.65 ml by water displacement. MDCT is a promising technique for measuring longitudinal changes in macaque ovarian morphology reliably and noninvasively.

The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome

PubMed Central

Dietrich, Johannes W; Stachon, Axel; Antic, Biljana; Klein, Harald H; Hering, Steffen

2008-01-01

Background Non-thyroidal illness syndrome (NTIS) is a characteristic functional constellation of thyrotropic feedback control that frequently occurs in critically ill patients. Although this condition is associated with significantly increased morbidity and mortality, there is still controversy on whether NTIS is caused by artefacts, is a form of beneficial adaptation, or is a disorder requiring treatment. Trials investigating substitution therapy of NTIS revealed contradictory results. The comparison of heterogeneous patient cohorts may be the cause for those inconsistencies. Objectives Primary objective of this study is the identification and differentiation of different functional states of thyrotropic feedback control in order to define relevant evaluation criteria for the prognosis of affected patients. Furthermore, we intend to assess the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent (so-called "sub-clinical") thyrotoxicosis. Secondary objective is observation of variables that quantify distinct components of NTIS in the context of independent predictors of evolution, survival or pathophysiological condition and influencing or disturbing factors like medication. Design The approach to a quantitative follow-up of non-thyroidal illness syndrome (AQUA FONTIS study) is designed as both a cross-sectional and prospective longitudinal observation trial in critically ill patients. Patients are observed in at least two evaluation points with consecutive assessments of thyroid status, physiological and clinical data in additional weekly observations up to discharge. A second part of the study investigates the neuropsychological impact of NTIS and medium-term outcomes. The study design incorporates a two-module structure that covers a reduced protocol in form of an observation trial before patients give informed consent. Additional investigations are performed if and after patients agree in participation. Trial Registration ClinicalTrials.gov NCT00591032 PMID:18851740

Efficacy of family mediation and the role of family violence: study protocol.

PubMed

Cleak, Helen; Schofield, Margot; Bickerdike, Andrew

2014-01-21

Family law reforms in Australia require separated parents in dispute to attempt mandatory family dispute resolution (FDR) in community-based family services before court attendance. However, there are concerns about such services when clients present with a history of high conflict and family violence. This study protocol describes a longitudinal study of couples presenting for family mediation services. The study aims to describe the profile of family mediation clients, including type of family violence, and determine the impact of violence profiles on FDR processes and outcomes, such as the type and durability of shared parenting arrangements and clients' satisfaction with mediated agreements. A mixed method, naturalistic longitudinal design is used. The sampling frame is clients presenting at nine family mediation centres across metropolitan, outer suburban, and regional/rural sites in Victoria, Australia. Data are collected at pre-test, completion of mediation, and six months later. Self-administered surveys are administered at the three time points, and a telephone interview at the final post-test. The key study variable is family violence. Key outcome measures are changes in the type and level of acrimony and violent behaviours, the relationship between violence and mediated agreements, the durability of agreements over six months, and client satisfaction with mediation. Family violence is a major risk to the physical and mental health of women and children. This study will inform debates about the role of family violence and how to manage it in the family mediation context. It will also inform decision-making about mediation practices by better understanding how mediation impacts on parenting agreements, and the implications for children, especially in the context of family violence.

Efficacy of family mediation and the role of family violence: study protocol

PubMed Central

2014-01-01

Background Family law reforms in Australia require separated parents in dispute to attempt mandatory family dispute resolution (FDR) in community-based family services before court attendance. However, there are concerns about such services when clients present with a history of high conflict and family violence. This study protocol describes a longitudinal study of couples presenting for family mediation services. The study aims to describe the profile of family mediation clients, including type of family violence, and determine the impact of violence profiles on FDR processes and outcomes, such as the type and durability of shared parenting arrangements and clients’ satisfaction with mediated agreements. Methods A mixed method, naturalistic longitudinal design is used. The sampling frame is clients presenting at nine family mediation centres across metropolitan, outer suburban, and regional/rural sites in Victoria, Australia. Data are collected at pre-test, completion of mediation, and six months later. Self-administered surveys are administered at the three time points, and a telephone interview at the final post-test. The key study variable is family violence. Key outcome measures are changes in the type and level of acrimony and violent behaviours, the relationship between violence and mediated agreements, the durability of agreements over six months, and client satisfaction with mediation. Discussion Family violence is a major risk to the physical and mental health of women and children. This study will inform debates about the role of family violence and how to manage it in the family mediation context. It will also inform decision-making about mediation practices by better understanding how mediation impacts on parenting agreements, and the implications for children, especially in the context of family violence. PMID:24443936

DVH- and NTCP-based dosimetric comparison of different longitudinal margins for VMAT-IMRT of esophageal cancer.

PubMed

Münch, S; Oechsner, M; Combs, S E; Habermehl, D

2017-08-15

To cover the microscopic tumor spread in squamous cell carcinoma of the esophagus (SCC), longitudinal margins of 3-4 cm are used for radiotherapy (RT) protocols. However, smaller margins of 2-3 cm might be reasonable when advanced diagnostic imaging is integrated into target volume delineation. Purpose of this study was to compare the dose distribution and deposition to the organs at risk (OAR) for different longitudinal margins using a DVH- and NTCP-based approach. Ten patients with SCC of the middle or lower third were retrospectively selected. Three planning target volumes (PTV) with longitudinal margins of 4 cm, 3 cm and 2 cm and an axial margin of 1.5 cm to the gross target volume (GTV) were defined for each patient. For each PTV two treatment plans with total doses of 41.4 Gy (neoadjuvant treatment) and 50.4 Gy (definite treatment) were calculated. Dose to the lungs, heart, myelon and liver were then evaluated and compared between different PTVs. When using a longitudinal margin of 3 cm instead of 4 cm, all dose parameters (Dmin, Dmean, Dmedian and V5-V35), except Dmax could be significantly reduced for the lungs. Regarding the heart, a significant reduction was seen for Dmean and V5, but not for Dmin, Dmax, Dmedian and V10-V35. When comparing a longitudinal margin of 4 cm to a longitudinal margin of 2 cm, a significant difference was calculated for Dmin, Dmean, Dmedian and V5-V35 of the lungs and for Dmax, Dmean and V5-V35 of the heart. Nevertheless, no difference was seen for median heart dose. An additional dose reduction for V10 of the heart was achieved for definite treatment plans when using a longitudinal margin of 3 cm. The NTCP-based risk of pneumonitis was significantly reduced by a margin reduction to 2 cm for neoadjuvant and definite treatment plans. Reduction of longitudinal margins from 4 cm to 3 cm can significantly reduce the dose to lungs and Dmean of the heart. Despite clinical benefit and oncologic outcome remain unclear, reduction of the longitudinal margins might provide the opportunity to reduce side effects of chemoradiation (CRT) for SCC in upcoming studies.

Redesigning a large school-based clinical trial in response to changes in community practice

PubMed Central

Gerald, Lynn B; Gerald, Joe K; McClure, Leslie A; Harrington, Kathy; Erwin, Sue; Bailey, William C

2011-01-01

Background Asthma exacerbations are seasonal with the greatest risk in elementary-age students occurring shortly after returning to school following summer break. Recent research suggests that this seasonality in children is primarily related to viral respiratory tract infections. Regular hand washing is the most effective method to prevent the spread of viral respiratory infections; unfortunately, achieving hand washing recommendations in schools is difficult. Therefore, we designed a study to evaluate the effect of hand sanitizer use in elementary schools on exacerbations among children with asthma. Purpose To describe the process of redesigning the trial in response to changes in the safety profile of the hand sanitizer as well as changes in hand hygiene practice in the schools. Methods The original trial was a randomized, longitudinal, subject-blinded, placebo-controlled, community-based crossover trial. The primary aim was to evaluate the incremental effectiveness of hand sanitizer use in addition to usual hand hygiene practices to decrease asthma exacerbations in elementary-age children. Three events occurred that required major modifications to the original study protocol: (1) safety concerns arose regarding the hand sanitizer’s active ingredient; (2) no substitute placebo hand sanitizer was available; and (3) community preferences changed regarding hand hygiene practices in the schools. Results The revised protocol is a randomized, longitudinal, community-based crossover trial. The primary aim is to evaluate the incremental effectiveness of a two-step hand hygiene process (hand hygiene education plus institutionally provided alcohol-based hand sanitizer) versus usual care to decrease asthma exacerbations. Enrollment was completed in May 2009 with 527 students from 30 schools. The intervention began in August 2009 and will continue through May 2011. Study results should be available at the end of 2011. Limitations The changed design does not allow us to directly measure the effectiveness of hand sanitizer use as a supplement to traditional hand washing practices. Conclusions The need to balance a rigorous study design with one that is acceptable to the community requires investigators to be actively involved with community collaborators and able to adapt study protocols to fit changing community practices. PMID:21730079

Redesigning a large school-based clinical trial in response to changes in community practice.

PubMed

Gerald, Lynn B; Gerald, Joe K; McClure, Leslie A; Harrington, Kathy; Erwin, Sue; Bailey, William C

2011-06-01

Asthma exacerbations are seasonal with the greatest risk in elementary-age students occurring shortly after returning to school following summer break. Recent research suggests that this seasonality in children is primarily related to viral respiratory tract infections. Regular hand washing is the most effective method to prevent the spread of viral respiratory infections; unfortunately, achieving hand washing recommendations in schools is difficult. Therefore, we designed a study to evaluate the effect of hand sanitizer use in elementary schools on exacerbations among children with asthma. To describe the process of redesigning the trial in response to changes in the safety profile of the hand sanitizer as well as changes in hand hygiene practice in the schools. The original trial was a randomized, longitudinal, subject-blinded, placebo-controlled, community-based crossover trial. The primary aim was to evaluate the incremental effectiveness of hand sanitizer use in addition to usual hand hygiene practices to decrease asthma exacerbations in elementary-age children. Three events occurred that required major modifications to the original study protocol: (1) safety concerns arose regarding the hand sanitizer's active ingredient; (2) no substitute placebo hand sanitizer was available; and (3) community preferences changed regarding hand hygiene practices in the schools. The revised protocol is a randomized, longitudinal, community-based crossover trial. The primary aim is to evaluate the incremental effectiveness of a two-step hand hygiene process (hand hygiene education plus institutionally provided alcohol-based hand sanitizer) versus usual care to decrease asthma exacerbations. Enrollment was completed in May 2009 with 527 students from 30 schools. The intervention began in August 2009 and will continue through May 2011. Study results should be available at the end of 2011. The changed design does not allow us to directly measure the effectiveness of hand sanitizer use as a supplement to traditional hand washing practices. The need to balance a rigorous study design with one that is acceptable to the community requires investigators to be actively involved with community collaborators and able to adapt study protocols to fit changing community practices.

Critical review of immediate implant loading.

PubMed

Gapski, Ricardo; Wang, Hom-Lay; Mascarenhas, Paulo; Lang, Niklaus P

2003-10-01

Implant dentistry has become successful with the discovery of the biological properties of titanium. In the original protocol, studies have advocated a 2-stage surgical protocol for load-free and submerged healing to ensure predictable osseointegration. However, the discomfort, inconvenience, and anxiety associated with waiting period remains a challenge to both patients and clinicians. Hence, loading implant right after placement was attempted and has gained popularity among clinicians. Issues/questions related to this approach remain unanswered. Therefore, it is the purpose of this review article to (1). review and analyze critically the current available literature in the field of immediate implant loading and (2). discuss, based on scientific evidence, factors that may influence this treatment modality. Literature published over the past 20 years was selected and reviewed. Findings from these studies were discussed and summarized in the tables. The advantages and disadvantages associated with immediate implant loading were analyzed. Factors that may influence the success of immediate implant loading, including patient selection, type of bone quality, required implant length, micro- and macrostructure of the implant, surgical skill, need for achieving primary stability/control of occlusal force, and prosthesis guidelines, were thoroughly reviewed and discussed. Various studies have demonstrated the feasibility and predictability of this technique. However, most of these articles are based on retrospective data or uncontrolled cases. Randomized, prospective, parallel-armed longitudinal human trials are primarily based on short-term results and long-term follow-ups are still scarce in this field. Nonetheless, from available literature, it may be concluded that anatomic locations, implant designs, and restricted prosthetic guidelines are key to ensure successful outcomes. Future studies, preferably randomized, prospective longitudinal studies, are certainly needed before this approach can be widely used.

Pattern of structural brain changes in social anxiety disorder after cognitive behavioral group therapy: a longitudinal multimodal MRI study.

PubMed

Steiger, V R; Brühl, A B; Weidt, S; Delsignore, A; Rufer, M; Jäncke, L; Herwig, U; Hänggi, J

2017-08-01

Social anxiety disorder (SAD) is characterized by fears of social and performance situations. Cognitive behavioral group therapy (CBGT) has in general positive effects on symptoms, distress and avoidance in SAD. Prior studies found increased cortical volumes and decreased fractional anisotropy (FA) in SAD compared with healthy controls (HCs). Thirty-three participants diagnosed with SAD attended in a 10-week CBGT and were scanned before and after therapy. We applied three neuroimaging methods-surface-based morphometry, diffusion tensor imaging and network-based statistics-each with specific longitudinal processing protocols, to investigate CBGT-induced structural brain alterations of the gray and white matter (WM). Surface-based morphometry revealed a significant cortical volume reduction (pre- to post-treatment) in the left inferior parietal cortex, as well as a positive partial correlation between treatment success (indexed by reductions in Liebowitz Social Anxiety Scale) and reductions in cortical volume in bilateral dorsomedial prefrontal cortex. Diffusion tensor imaging analysis revealed a significant increase in FA in bilateral uncinate fasciculus and right inferior longitudinal fasciculus. Network-based statistics revealed a significant increase of structural connectivity in a frontolimbic network. No partial correlations with treatment success have been found in WM analyses. For, we believe, the first time, we present a distinctive pattern of longitudinal structural brain changes after CBGT measured with three established magnetic resonance imaging analyzing techniques. Our findings are in line with previous cross-sectional, unimodal SAD studies and extent them by highlighting anatomical brain alterations that point toward the level of HCs in parallel with a reduction in SAD symptomatology.

An Examination of Effective Practice: Moving Toward Elimination of Achievement Gaps in Science

NASA Astrophysics Data System (ADS)

Johnson, Carla C.

2009-06-01

This longitudinal study of middle school science teachers explored the relationship between effective science instruction, as defined by the National Science Education Standards (NRC in National science education standards. National Academy Press, Washington, DC, 1996), and student achievement in science. Eleven teachers participated in a three year study of teacher effectiveness, determined by the LSC Classroom Observation Protocol (Horizon Research, Inc. in Local Systemic Change Classroom Observation Protocol. May 1, 2002) and student achievement, which was assessed using the Discovery Inquiry Test in Science. Findings in this study revealed the positive impact that effective science teachers have on student learning, eliminating achievement gaps between White and Non-White students. Case studies of three teachers, both effective and ineffective explore the beliefs and experiences that influence teachers to change, or not to change practice. This study provides justification for teaching science effectively to narrow achievement gaps in science and provides insight to stakeholders in science education as to how to support teachers in becoming more effective, through addressing existing teacher beliefs and providing experiences that challenge those beliefs.

COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis.

PubMed

Palmer, Suetonia C; Ruospo, Marinella; Barulli, Maria Rosaria; Iurillo, Annalisa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Murgo, Angelo M; Loy, Clement; van Zwieten, Anita; Wong, Germaine; Tortelli, Rosanna; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Hegbrant, Jörgen; Wollheim, Charlotta; Logroscino, Giancarlo; Strippoli, G F M

2015-12-09

The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes. A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months. This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61-62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants have provided written and informed consent and can withdraw from the study at any time. The findings of the study will be disseminated through peer-reviewed journals and national and international conference presentations and to the participants through communication within the dialysis network in which this study is conducted. 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/

Multiphoton Intravital Calcium Imaging.

PubMed

Cheetham, Claire E J

2018-06-26

Multiphoton intravital calcium imaging is a powerful technique that enables high-resolution longitudinal monitoring of cellular and subcellular activity hundreds of microns deep in the living organism. This unit addresses the application of 2-photon microscopy to imaging of genetically encoded calcium indicators (GECIs) in the mouse brain. The protocols in this unit enable real-time intravital imaging of intracellular calcium concentration simultaneously in hundreds of neurons, or at the resolution of single synapses, as mice respond to sensory stimuli or perform behavioral tasks. Protocols are presented for implantation of a cranial imaging window to provide optical access to the brain and for 2-photon image acquisition. Protocols for implantation of both open skull and thinned skull windows for single or multi-session imaging are described. © 2018 by John Wiley & Sons, Inc. © 2018 John Wiley & Sons, Inc.

Do we need 3D tube current modulation information for accurate organ dosimetry in chest CT? Protocols dose comparisons.

PubMed

Lopez-Rendon, Xochitl; Zhang, Guozhi; Coudyzer, Walter; Develter, Wim; Bosmans, Hilde; Zanca, Federica

2017-11-01

To compare the lung and breast dose associated with three chest protocols: standard, organ-based tube current modulation (OBTCM) and fast-speed scanning; and to estimate the error associated with organ dose when modelling the longitudinal (z-) TCM versus the 3D-TCM in Monte Carlo simulations (MC) for these three protocols. Five adult and three paediatric cadavers with different BMI were scanned. The CTDI vol of the OBTCM and the fast-speed protocols were matched to the patient-specific CTDI vol of the standard protocol. Lung and breast doses were estimated using MC with both z- and 3D-TCM simulated and compared between protocols. The fast-speed scanning protocol delivered the highest doses. A slight reduction for breast dose (up to 5.1%) was observed for two of the three female cadavers with the OBTCM in comparison to the standard. For both adult and paediatric, the implementation of the z-TCM data only for organ dose estimation resulted in 10.0% accuracy for the standard and fast-speed protocols, while relative dose differences were up to 15.3% for the OBTCM protocol. At identical CTDI vol values, the standard protocol delivered the lowest overall doses. Only for the OBTCM protocol is the 3D-TCM needed if an accurate (<10.0%) organ dosimetry is desired. • The z-TCM information is sufficient for accurate dosimetry for standard protocols. • The z-TCM information is sufficient for accurate dosimetry for fast-speed scanning protocols. • For organ-based TCM schemes, the 3D-TCM information is necessary for accurate dosimetry. • At identical CTDI vol , the fast-speed scanning protocol delivered the highest doses. • Lung dose was higher in XCare than standard protocol at identical CTDI vol .

Temporal Precedence Checking for Switched Models and its Application to a Parallel Landing Protocol

NASA Technical Reports Server (NTRS)

Duggirala, Parasara Sridhar; Wang, Le; Mitra, Sayan; Viswanathan, Mahesh; Munoz, Cesar A.

2014-01-01

This paper presents an algorithm for checking temporal precedence properties of nonlinear switched systems. This class of properties subsume bounded safety and capture requirements about visiting a sequence of predicates within given time intervals. The algorithm handles nonlinear predicates that arise from dynamics-based predictions used in alerting protocols for state-of-the-art transportation systems. It is sound and complete for nonlinear switch systems that robustly satisfy the given property. The algorithm is implemented in the Compare Execute Check Engine (C2E2) using validated simulations. As a case study, a simplified model of an alerting system for closely spaced parallel runways is considered. The proposed approach is applied to this model to check safety properties of the alerting logic for different operating conditions such as initial velocities, bank angles, aircraft longitudinal separation, and runway separation.

Murine chronic lymph node window for longitudinal intravital lymph node imaging.

PubMed

Meijer, Eelco F J; Jeong, Han-Sin; Pereira, Ethel R; Ruggieri, Thomas A; Blatter, Cedric; Vakoc, Benjamin J; Padera, Timothy P

2017-08-01

Chronic imaging windows in mice have been developed to allow intravital microscopy of many different organs and have proven to be of paramount importance in advancing our knowledge of normal and disease processes. A model system that allows long-term intravital imaging of lymph nodes would facilitate the study of cell behavior in lymph nodes during the generation of immune responses in a variety of disease settings and during the formation of metastatic lesions in cancer-bearing mice. We describe a chronic lymph node window (CLNW) surgical preparation that allows intravital imaging of the inguinal lymph node in mice. The CLNW is custom-made from titanium and incorporates a standard coverslip. It allows stable longitudinal imaging without the need for serial surgeries while preserving lymph node blood and lymph flow. We also describe how to build and use an imaging stage specifically designed for the CLNW to prevent (large) rotational changes as well as respiratory movement during imaging. The entire procedure takes approximately half an hour per mouse, and subsequently allows for longitudinal intravital imaging of the murine lymph node and surrounding structures for up to 14 d. Small-animal surgery experience is required to successfully carry out the protocol.

Simultaneous maximum a posteriori longitudinal PET image reconstruction

NASA Astrophysics Data System (ADS)

Ellis, Sam; Reader, Andrew J.

2017-09-01

Positron emission tomography (PET) is frequently used to monitor functional changes that occur over extended time scales, for example in longitudinal oncology PET protocols that include routine clinical follow-up scans to assess the efficacy of a course of treatment. In these contexts PET datasets are currently reconstructed into images using single-dataset reconstruction methods. Inspired by recently proposed joint PET-MR reconstruction methods, we propose to reconstruct longitudinal datasets simultaneously by using a joint penalty term in order to exploit the high degree of similarity between longitudinal images. We achieved this by penalising voxel-wise differences between pairs of longitudinal PET images in a one-step-late maximum a posteriori (MAP) fashion, resulting in the MAP simultaneous longitudinal reconstruction (SLR) method. The proposed method reduced reconstruction errors and visually improved images relative to standard maximum likelihood expectation-maximisation (ML-EM) in simulated 2D longitudinal brain tumour scans. In reconstructions of split real 3D data with inserted simulated tumours, noise across images reconstructed with MAP-SLR was reduced to levels equivalent to doubling the number of detected counts when using ML-EM. Furthermore, quantification of tumour activities was largely preserved over a variety of longitudinal tumour changes, including changes in size and activity, with larger changes inducing larger biases relative to standard ML-EM reconstructions. Similar improvements were observed for a range of counts levels, demonstrating the robustness of the method when used with a single penalty strength. The results suggest that longitudinal regularisation is a simple but effective method of improving reconstructed PET images without using resolution degrading priors.

External Quality Control for Dried Blood Spot Based C-reactive Protein Assay: Experience from the Indonesia Family Life Survey and the Longitudinal Aging Study in India

PubMed Central

Hu, Peifeng; Herningtyas, Elizabeth H.; Kale, Varsha; Crimmins, Eileen M.; Risbud, Arun R.; McCreath, Heather; Lee, Jinkook; Strauss, John; O’Brien, Jennifer C.; Bloom, David E.; Seeman, Teresa E.

2015-01-01

Measurement of C-reactive protein, a marker of inflammation, in dried blood spots has been increasingly incorporated in community-based social surveys internationally. Although the dried blood spot based CRP assay protocol has been validated in the United States, it remains unclear whether laboratories in other less developed countries can generate C-reactive protein results of similar quality. We therefore conducted external quality monitoring for dried blood spot based C-reactive protein measurement for the Indonesia Family Life Survey and the Longitudinal Aging Study in India. Our results show that dried blood spot based C-reactive protein results in these two countries have excellent and consistent correlations with serum-based values and dried blood spot based results from the reference laboratory in the United States. Even though the results from duplicate samples may have fluctuations in absolute values over time, the relative order of C-reactive protein levels remains similar and the estimates are reasonably precise for population-based studies that investigate the association between socioeconomic factors and health. PMID:25879265

Stent longitudinal integrity bench insights into a clinical problem.

PubMed

Ormiston, John A; Webber, Bruce; Webster, Mark W I

2011-12-01

Standardized bench-top compression and elongation testing was undertaken to assess the longitudinal strength of contemporary stents. Insights gained may improve clinical stent choice and deployment techniques, and facilitate future stent design improvements. The hoops of coronary stents provide radial support, and connectors hold hoops together. Strut material, shape, and thickness, along with connector number and configuration, provide the balance between stent flexibility and longitudinal integrity. Longitudinal distortion manifests as length change, strut overlap, strut separation, malapposition, and luminal obstruction. These may predispose to restenosis and stent thrombosis, obstruct passage of devices, be misinterpreted as strut fracture, and require additional stenting. The force required to compress and to elongate 7 contemporary stents was measured with an Instron universal testing machine (Norwood, Massachusetts). Stents deployed in a silicone phantom damaged by a balloon or guide catheter were imaged by microcomputed tomography to understand better the appearances and effects of longitudinal distortion. Stents with 2 connectors (Boston Scientific [Natick, Massachusetts] Omega and Medtronic [Santa Rosa, California] Driver) required significantly less force to be compressed up to 5 mm and elongated by 1 mm than designs with more connectors. The 6-connector Cypher Select required significantly more force to be elongated 5 mm than other designs. Stents with 2 connectors between hoops have less longitudinal strength when exposed to compressing or elongating forces than those with more connectors. This independent, standardized study may assist stent selection in clinical situations where longitudinal integrity is important, and may aid future design improvements. Stent longitudinal strength, the resistance to shortening or elongation, appears related to the number of connectors between hoops. Using a standardized testing protocol, designs with 2 connectors were more likely to shorten or elongate than those with more connectors. Distortion may be recognized clinically as bunching or separation of struts, and may be confused with strut fracture. Without post-dilation or further stent deployment, the patient may be at increased risk for adverse clinical events. A stent design change ensuring 3 connectors, especially at the proximal end of a stent, should increase longitudinal integrity, but perhaps at the expense of stent flexibility. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Multisite longitudinal reliability of tract-based spatial statistics in diffusion tensor imaging of healthy elderly subjects.

PubMed

Jovicich, Jorge; Marizzoni, Moira; Bosch, Beatriz; Bartrés-Faz, David; Arnold, Jennifer; Benninghoff, Jens; Wiltfang, Jens; Roccatagliata, Luca; Picco, Agnese; Nobili, Flavio; Blin, Oliver; Bombois, Stephanie; Lopes, Renaud; Bordet, Régis; Chanoine, Valérie; Ranjeva, Jean-Philippe; Didic, Mira; Gros-Dagnac, Hélène; Payoux, Pierre; Zoccatelli, Giada; Alessandrini, Franco; Beltramello, Alberto; Bargalló, Núria; Ferretti, Antonio; Caulo, Massimo; Aiello, Marco; Ragucci, Monica; Soricelli, Andrea; Salvadori, Nicola; Tarducci, Roberto; Floridi, Piero; Tsolaki, Magda; Constantinidis, Manos; Drevelegas, Antonios; Rossini, Paolo Maria; Marra, Camillo; Otto, Josephin; Reiss-Zimmermann, Martin; Hoffmann, Karl-Titus; Galluzzi, Samantha; Frisoni, Giovanni B

2014-11-01

Large-scale longitudinal neuroimaging studies with diffusion imaging techniques are necessary to test and validate models of white matter neurophysiological processes that change in time, both in healthy and diseased brains. The predictive power of such longitudinal models will always be limited by the reproducibility of repeated measures acquired during different sessions. At present, there is limited quantitative knowledge about the across-session reproducibility of standard diffusion metrics in 3T multi-centric studies on subjects in stable conditions, in particular when using tract based spatial statistics and with elderly people. In this study we implemented a multi-site brain diffusion protocol in 10 clinical 3T MRI sites distributed across 4 countries in Europe (Italy, Germany, France and Greece) using vendor provided sequences from Siemens (Allegra, Trio Tim, Verio, Skyra, Biograph mMR), Philips (Achieva) and GE (HDxt) scanners. We acquired DTI data (2 × 2 × 2 mm(3), b = 700 s/mm(2), 5 b0 and 30 diffusion weighted volumes) of a group of healthy stable elderly subjects (5 subjects per site) in two separate sessions at least a week apart. For each subject and session four scalar diffusion metrics were considered: fractional anisotropy (FA), mean diffusivity (MD), radial diffusivity (RD) and axial (AD) diffusivity. The diffusion metrics from multiple subjects and sessions at each site were aligned to their common white matter skeleton using tract-based spatial statistics. The reproducibility at each MRI site was examined by looking at group averages of absolute changes relative to the mean (%) on various parameters: i) reproducibility of the signal-to-noise ratio (SNR) of the b0 images in centrum semiovale, ii) full brain test-retest differences of the diffusion metric maps on the white matter skeleton, iii) reproducibility of the diffusion metrics on atlas-based white matter ROIs on the white matter skeleton. Despite the differences of MRI scanner configurations across sites (vendors, models, RF coils and acquisition sequences) we found good and consistent test-retest reproducibility. White matter b0 SNR reproducibility was on average 7 ± 1% with no significant MRI site effects. Whole brain analysis resulted in no significant test-retest differences at any of the sites with any of the DTI metrics. The atlas-based ROI analysis showed that the mean reproducibility errors largely remained in the 2-4% range for FA and AD and 2-6% for MD and RD, averaged across ROIs. Our results show reproducibility values comparable to those reported in studies using a smaller number of MRI scanners, slightly different DTI protocols and mostly younger populations. We therefore show that the acquisition and analysis protocols used are appropriate for multi-site experimental scenarios. Copyright © 2014 Elsevier Inc. All rights reserved.

Tailored frequency-escalated primary prophylaxis for severe haemophilia A: results of the 16-year Canadian Hemophilia Prophylaxis Study longitudinal cohort.

PubMed

Feldman, Brian M; Rivard, Georges E; Babyn, Paul; Wu, John K M; Steele, MacGregor; Poon, Man-Chiu; Card, Robert T; Israels, Sara J; Laferriere, Nicole; Gill, Kulwant; Chan, Anthony K; Carcao, Manuel; Klaassen, Robert J; Cloutier, Stephanie; Price, Victoria E; Dover, Saunya; Blanchette, Victor S

2018-06-01

Severe haemophilia A has high morbidity, and treatment, while effective, is very expensive. We report the 16-year follow-up of the Canadian Hemophilia Prophylaxis Study, which examined the effectiveness of tailored frequency-escalated primary prophylaxis with a focus on health outcomes within the domains of body structures and functions, and activities and participation (according to the WHO International Classification of Functioning, Disability and Health [WHO-ICF] framework) and a view to reducing consumption of costly clotting factor, which accounts for more than 90% of the cost of care of severe haemophilia. In this longitudinal study, boys with severe haemophilia A from 12 Canadian centres were enrolled at age 1·0-2·5 years. They were treated with standard half-life recombinant factor VIII (SHL-rFVIII), beginning as once-weekly prophylaxis with 50 IU/kg and escalating in frequency (with accompanying dose adjustments) in response to breakthrough bleeding as determined by the protocol. The primary endpoint for this analysis was joint health, as measured by the modified Colorado Child Physical Examination Scores (CCPES) at study end. All analyses were done by intention to treat. The trial is complete, and is registered with ClinicalTrials.gov, number NCT01085344. Between June 26, 1997, and Jan 30, 2007, 56 boys were enrolled. They were followed for a median of 10·2 years (to a maximum of 16·1 years). Median rFVIII usage was about 3600 IU/kg per year. The median end-of-study CCPES physical examination score was 1 (IQR 1-3; range 0-12) for the left ankle and 1 (1-2; 0-12) for the right ankle, with all other joints having a median score of 0. No treatment-related safety events occurred over the duration of the study, including central venous catheter infections. The median annualised index joint bleeding rate was 0·95 per year (IQR 0·44-1·35; range 0·00-13·43), but 17 (30%) patients had protocol-defined unacceptable breakthrough bleeding at some point during the study. Tailored frequency-escalated prophylaxis leads to very little arthropathy and very good health outcomes within the WHO-ICF domains, and only uses a moderate amount of expensive clotting factor as compared with standard prophylaxis protocols. Some sequelae of bleeding were observed in our cohort, and future studies should consider a more stringent protocol of escalation. This study was initially funded by grants from the Medical Research Council of Canada/Pharmaceutical Manufacturers Association of Canada Partnership Fund and the Bayer/Canadian Blood Services/Hema-Quebec Partnership Fund. Subsequent renewals were funded by Bayer. Copyright © 2018 Elsevier Ltd. All rights reserved.

A longitudinal study of the impact of chronic psychological stress on health-related quality of life and clinical biomarkers: protocol for the Australian Healthy Aging of Women Study.

PubMed

Seib, Charrlotte; Whiteside, Eliza; Humphreys, Janice; Lee, Kathryn; Thomas, Patrick; Chopin, Lisa; Crisp, Gabrielle; O'Keeffe, Angela; Kimlin, Michael; Stacey, Andrew; Anderson, Debra

2014-01-08

Despite advancements in our understanding of the importance of stress reduction in achieving good health, we still only have limited insight into the impact of stress on cellular function. Recent studies have suggested that exposure to prolonged psychological stress may alter an individual's physiological responses, and contribute to morbidity and mortality. This paper presents an overview of the study protocol we are using to examine the impact of life stressors on lifestyle factors, health-related quality of life and novel and established biomarkers of stress in midlife and older Australian women.The primary aim of this study is to explore the links between chronic psychological stress on both subjective and objective health markers in midlife and older Australian women. The study examines the extent to which exposure frightening, upsetting or stressful events such as natural disasters, illness or death of a relative, miscarriage and relationship conflict is correlated with a variety of objective and subjective health markers. This study is embedded within the longitudinal Healthy Aging of Women's study which has collected data from midlife and older Australian women at 5 yearly intervals since 2001, and uses the Allostastic model of women's health by Groër and colleagues in 2010. The current study expands the focus of the HOW study and will assess the impact of life stressors on quality of life and clinical biomarkers in midlife and older Australian women to explain the impact of chronic psychological stress in women. The proposed study hypothesizes that women are at increased risk of exposure to multiple or repeated stressors, some being unique to women, and the frequency and chronicity of stressors increases women's risk of adverse health outcomes. This study aims to further our understanding of the relationships between stressful life experiences, perceived quality of life, stress biomarkers, chronic illness, and health status in women.

Improving the consistency in cervical esophageal target volume definition by special training.

PubMed

Tai, Patricia; Van Dyk, Jake; Battista, Jerry; Yu, Edward; Stitt, Larry; Tonita, Jon; Agboola, Olusegun; Brierley, James; Dar, Rashid; Leighton, Christopher; Malone, Shawn; Strang, Barbara; Truong, Pauline; Videtic, Gregory; Wong, C Shun; Wong, Rebecca; Youssef, Youssef

2002-07-01

Three-dimensional conformal radiation therapy requires the precise definition of the target volume. Its potential benefits could be offset by the inconsistency in target definition by radiation oncologists. In a previous survey of radiation oncologists, a large degree of variation in target volume definition of cervical esophageal cancer was noted for the boost phase of radiotherapy. The present study evaluated whether special training could improve the consistency in target volume definitions. A pre-training survey was performed to establish baseline values. This was followed by a special one-on-one training session on treatment planning based on the RTOG 94-05 protocol to 12 radiation oncologists. Target volumes were redrawn immediately and at 1-2 months later. Post-training vs. pre-training target volumes were compared. There was less variability in the longitudinal positions of the target volumes post-training compared to pre-training (p < 0.05 in 5 of 6 comparisons). One case had more variability due to the lack of a visible gross tumor on CT scans. Transverse contours of target volumes did not show any significant difference pre- or post-training. For cervical esophageal cancer, this study suggests that special training on protocol guidelines may improve consistency in target volume definition. Explicit protocol directions are required for situations where the gross tumor is not easily visible on CT scans. This may be particularly important for multicenter clinical trials, to reduce the occurrences of protocol violations.

Suicide Risk Management Protocol in Post-Cardiac Arrest Survivors: Development, Feasibility, and Outcomes.

PubMed

Bucy, Rachel A; Hanisko, Kaitlyn A; Kamphuis, Lee A; Nallamothu, Brahmajee K; Iwashyna, Theodore J; Pfeiffer, Paul N

2017-03-01

Suicidal ideation is an important part of the spectrum of depression, but studies of outcomes after cardiac events often avoid asking about suicide as part of their assessment due to perceived resource constraints and the complexity of managing this finding. To describe the development, feasibility, and outcomes of a suicide risk management protocol implemented by research assistants administering the Patient Health Questionnaire Depression Scale (PHQ-9). Patients surviving in-hospital cardiac arrest at any Veterans Affairs hospital during 2014 to 2015 received PHQ-9 screening as a part of longitudinal telephone or mail interviews administered at 3, 6, 9, and 12 months after hospital discharge. Those who screened positive for suicidal ideation were administered a telephone risk assessment protocol. Fifty-five of 366 (15%) interviewed Veterans endorsed suicidal ideation according to the PHQ-9 on 82 of their completed interviews. Of those who endorsed suicidal ideation during their interview, 81% of interviews included passive suicidal ideation without intent or plan. Five (9%) patients were recommended to receive expedited follow-up with a mental health provider or suicide prevention coordinator located within their Veterans Affairs healthcare facility. In 50 (63%) interviews, the patient already had reliable resources, such as a mental health provider or the number to the Veterans Crisis Line. Suicidal ideation is common after in-hospital cardiac arrest, although most patients are at low risk. Addressing suicidal ideation in an observational research study is feasible, with a detailed protocol and research staff who can respond to incidents of high-risk suicidal ideation in collaboration with study clinicians.

Imaging of cardiac perfusion of free-breathing small animals using dynamic phase-correlated micro-CT

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

Sawall, Stefan; Kuntz, Jan; Socher, Michaela

Purpose:Mouse models of cardiac diseases have proven to be a valuable tool in preclinical research. The high cardiac and respiratory rates of free breathing mice prohibit conventional in vivo cardiac perfusion studies using computed tomography even if gating methods are applied. This makes a sacrification of the animals unavoidable and only allows for the application of ex vivo methods. Methods: To overcome this issue the authors propose a low dose scan protocol and an associated reconstruction algorithm that allows for in vivo imaging of cardiac perfusion and associated processes that are retrospectively synchronized to the respiratory and cardiac motion ofmore » the animal. The scan protocol consists of repetitive injections of contrast media within several consecutive scans while the ECG, respiratory motion, and timestamp of contrast injection are recorded and synchronized to the acquired projections. The iterative reconstruction algorithm employs a six-dimensional edge-preserving filter to provide low-noise, motion artifact-free images of the animal examined using the authors' low dose scan protocol. Results: The reconstructions obtained show that the complete temporal bolus evolution can be visualized and quantified in any desired combination of cardiac and respiratory phase including reperfusion phases. The proposed reconstruction method thereby keeps the administered radiation dose at a minimum and thus reduces metabolic inference to the animal allowing for longitudinal studies. Conclusions: The authors' low dose scan protocol and phase-correlated dynamic reconstruction algorithm allow for an easy and effective way to visualize phase-correlated perfusion processes in routine laboratory studies using free-breathing mice.« less

Assessing the impact of a food supplement on the nutritional status and body composition of HIV-infected Zambian women on ARVs.

PubMed

Zulu, Rodah M; Byrne, Nuala M; Munthali, Grace K; Chipeta, James; Handema, Ray; Musonda, Mofu; Hills, Andrew P

2011-09-21

Zambia is a sub-Saharan country with one of the highest prevalence rates of HIV, currently estimated at 14%. Poor nutritional status due to both protein-energy and micronutrient malnutrition has worsened this situation. In an attempt to address this combined problem, the government has instigated a number of strategies, including the provision of antiretroviral (ARV) treatment coupled with the promotion of good nutrition. High-energy protein supplement (HEPS) is particularly promoted; however, the impact of this food supplement on the nutritional status of people living with HIV/AIDS (PLHA) beyond weight gain has not been assessed. Techniques for the assessment of nutritional status utilising objective measures of body composition are not commonly available in Zambia. The aim of this study is therefore to assess the impact of a food supplement on nutritional status using a comprehensive anthropometric protocol including measures of skinfold thickness and circumferences, plus the criterion deuterium dilution technique to assess total body water (TBW) and derive fat-free mass (FFM) and fat mass (FM). This community-based controlled and longitudinal study aims to recruit 200 HIV-infected females commencing ARV treatment at two clinics in Lusaka, Zambia. Data will be collected at four time points: baseline, 4-month, 8-month and 12-month follow-up visits. Outcome measures to be assessed include body height and weight, body mass index (BMI), body composition, CD4, viral load and micronutrient status. This protocol describes a study that will provide a longitudinal assessment of the impact of a food supplement on the nutritional status of HIV-infected females initiating ARVs using a range of anthropometric and body composition assessment techniques. Pan African Clinical Trial Registry PACTR201108000303396.

Assessing the impact of a food supplement on the nutritional status and body composition of HIV-infected Zambian women on ARVs

PubMed Central

2011-01-01

Background Zambia is a sub-Saharan country with one of the highest prevalence rates of HIV, currently estimated at 14%. Poor nutritional status due to both protein-energy and micronutrient malnutrition has worsened this situation. In an attempt to address this combined problem, the government has instigated a number of strategies, including the provision of antiretroviral (ARV) treatment coupled with the promotion of good nutrition. High-energy protein supplement (HEPS) is particularly promoted; however, the impact of this food supplement on the nutritional status of people living with HIV/AIDS (PLHA) beyond weight gain has not been assessed. Techniques for the assessment of nutritional status utilising objective measures of body composition are not commonly available in Zambia. The aim of this study is therefore to assess the impact of a food supplement on nutritional status using a comprehensive anthropometric protocol including measures of skinfold thickness and circumferences, plus the criterion deuterium dilution technique to assess total body water (TBW) and derive fat-free mass (FFM) and fat mass (FM). Methods/Design This community-based controlled and longitudinal study aims to recruit 200 HIV-infected females commencing ARV treatment at two clinics in Lusaka, Zambia. Data will be collected at four time points: baseline, 4-month, 8-month and 12-month follow-up visits. Outcome measures to be assessed include body height and weight, body mass index (BMI), body composition, CD4, viral load and micronutrient status. Discussion This protocol describes a study that will provide a longitudinal assessment of the impact of a food supplement on the nutritional status of HIV-infected females initiating ARVs using a range of anthropometric and body composition assessment techniques. Trial Registration Pan African Clinical Trial Registry PACTR201108000303396. PMID:21936938

Noninvasive Longitudinal Study of a Magnetic Resonance Imaging Biomarker for the Quantification of Colon Inflammation in a Mouse Model of Colitis.

PubMed

Bianchi, Andrea; Bluhmki, Teresa; Schönberger, Tanja; Kaaru, Eric; Beltzer, Anne; Raymond, Ernest; Wunder, Andreas; Thakker, Paresh; Stierstorfer, Birgit; Stiller, Detlef

2016-06-01

Colonoscopy is the gold standard to diagnose and follow up the evolution of inflammatory bowel diseases. However, this technique can still present a risk of severe complications, a general discomfort in patients, and its diagnostic value is limited to the visualization of the colon mucosal changes. Magnetic resonance imaging (MRI) is emerging as a noninvasive imaging technique of choice to overcome these limitations. The aim of this work was to evaluate the potential of colon wall thickness measured using MRI as an in vivo imaging biomarker of inflammation for inflammatory bowel disease in an animal model of this disease. On day 0, 2% or 3% Dextran sodium sulfate was added to the drinking water of mice (n = 10/group) for 5 days. Six mice were left as controls. Animals were imaged with colonoscopy and MRI on days 7, 11, and 21 to study the colitis progression. Histology was performed at the end of the protocol. The colon wall thickness measured in Dextran sodium sulfate-treated animals was shown to be significantly and dose dependently increased compared to controls. Colonoscopy showed similar results and excellently correlated with MRI measurements and histology. The proposed protocol showed high robustness, with negligible interoperator and intraoperator variability. The findings of this investigation suggest the feasibility of using MRI for the noninvasive assessment of colon wall thickness as a robust surrogate biomarker for colon inflammation detection and follow-up. The data presented show the potential of MRI in in vivo preclinical longitudinal studies, including testing of new drugs or investigation of inflammatory bowel disease development mechanisms.

Measuring vascular reactivity with breath-holds after stroke: a method to aid interpretation of group-level BOLD signal changes in longitudinal fMRI studies.

PubMed

Geranmayeh, Fatemeh; Wise, Richard J S; Leech, Robert; Murphy, Kevin

2015-05-01

Blood oxygenation level-dependent (BOLD) contrast functional magnetic resonance imaging (fMRI) is a widely used technique to map brain function, and to monitor its recovery after stroke. Since stroke has a vascular etiology, the neurovascular coupling between cerebral blood flow and neural activity may be altered, resulting in uncertainties when interpreting longitudinal BOLD signal changes. The purpose of this study was to demonstrate the feasibility of using a recently validated breath-hold task in patients with stroke, both to assess group level changes in cerebrovascular reactivity (CVR) and to determine if alterations in regional CVR over time will adversely affect interpretation of task-related BOLD signal changes. Three methods of analyzing the breath-hold data were evaluated. The CVR measures were compared over healthy tissue, infarcted tissue and the peri-infarct tissue, both sub-acutely (∼2 weeks) and chronically (∼4 months). In this cohort, a lack of CVR differences in healthy tissue between the patients and controls indicates that any group level BOLD signal change observed in these regions over time is unlikely to be related to vascular alterations. CVR was reduced in the peri-infarct tissue but remained unchanged over time. Therefore, although a lack of activation in this region compared with the controls may be confounded by a reduced CVR, longitudinal group-level BOLD changes may be more confidently attributed to neural activity changes in this cohort. By including this breath-hold-based CVR assessment protocol in future studies of stroke recovery, researchers can be more assured that longitudinal changes in BOLD signal reflect true alterations in neural activity. © 2015 The Authors Human Brain Mapping Published by Wiley Periodicals, Inc.

How does tissue preparation affect skeletal muscle transverse isotropy?

PubMed Central

Wheatley, Benjamin B.; Odegard, Gregory M.; Kaufman, Kenton R.; Haut Donahue, Tammy L.

2016-01-01

The passive tensile properties of skeletal muscle play a key role in its physiological function. Previous research has identified conflicting reports of muscle transverse isotropy, with some data suggesting the longitudinal direction is stiffest, while others show the transverse direction is stiffest. Accurate constitutive models of skeletal muscle must be employed to provide correct recommendations for and observations of clinical methods. The goal of this work was to identify transversely isotropic tensile muscle properties as a function of post mortem handling. Six pairs of tibialis anterior muscles were harvested from Giant Flemish rabbits and split into two groups: fresh testing (within four hours post mortem), and non-fresh testing (subject to delayed testing and a freeze/thaw cycle). Longitudinal and transverse samples were removed from each muscle and tested to identify tensile modulus and relaxation behavior. Longitudinal non-fresh samples exhibited a higher initial modulus value and faster relaxation than longitudinal fresh, transverse fresh, and transverse rigor samples (p<0.05), while longitudinal fresh samples were less stiff at lower strain levels than longitudinal non-fresh, transverse fresh, and transverse non-fresh samples (p<0.05), but exhibited more nonlinear behavior. While fresh skeletal muscle exhibits a higher transverse modulus than longitudinal modulus, discrepancies in previously published data may be the result of a number of differences in experimental protocol. Constitutive modeling of fresh muscle should reflect these data by identifying the material as truly transversely isotropic and not as an isotropic matrix reinforced with fibers. PMID:27425557

Quantitative quality assurance in a multicenter HARDI clinical trial at 3T.

PubMed

Zhou, Xiaopeng; Sakaie, Ken E; Debbins, Josef P; Kirsch, John E; Tatsuoka, Curtis; Fox, Robert J; Lowe, Mark J

2017-01-01

A phantom-based quality assurance (QA) protocol was developed for a multicenter clinical trial including high angular resolution diffusion imaging (HARDI). A total of 27 3T MR scanners from 2 major manufacturers, GE (Discovery and Signa scanners) and Siemens (Trio and Skyra scanners), were included in this trial. With this protocol, agar phantoms doped to mimic relaxation properties of brain tissue are scanned on a monthly basis, and quantitative procedures are used to detect spiking and to evaluate eddy current and Nyquist ghosting artifacts. In this study, simulations were used to determine alarm thresholds for minimal acceptable signal-to-noise ratio (SNR). Our results showed that spiking artifact was the most frequently observed type of artifact. Overall, Trio scanners exhibited less eddy current distortion than GE scanners, which in turn showed less distortion than Skyra scanners. This difference was mainly caused by the different sequences used on these scanners. The SNR for phantom scans was closely correlated with the SNR from volunteers. Nearly all of the phantom measurements with artifact-free images were above the alarm threshold, suggesting that the scanners are stable longitudinally. Software upgrades and hardware replacement sometimes affected SNR substantially but sometimes did not. In light of these results, it is important to monitor longitudinal SNR with phantom QA to help interpret potential effects on in vivo measurements. Our phantom QA procedure for HARDI scans was successful in tracking scanner performance and detecting unwanted artifacts. Copyright © 2016 Elsevier Inc. All rights reserved.

Quantitative Quality Assurance in a Multicenter HARDI Clinical Trial at 3T

PubMed Central

Zhou, Xiaopeng; Sakaie, Ken E.; Debbins, Josef P.; Kirsch, John E.; Tatsuoka, Curtis; Fox, Robert J.; Lowe, Mark J.

2016-01-01

A phantom-based quality assurance (QA) protocol was developed for a multicenter clinical trial including high angular resolution diffusion imaging (HARDI). A total of 27 3T MR scanners from 2 major manufacturers, GE (Discovery and Signa scanners) and Siemens (Trio and Skyra scanners), were included in this trial. With this protocol, agar phantoms doped to mimic relaxation properties of brain tissue are scanned on a monthly basis, and quantitative procedures are used to detect spiking and to evaluate eddy current and Nyquist ghosting artifacts. In this study, simulations were used to determine alarm thresholds for minimal acceptable signal-to-noise ratio (SNR). Our results showed that spiking artifact was the most frequently observed type of artifact. Overall, Trio scanners exhibited less eddy current distortion than GE scanners, which in turn showed less distortion than Skyra scanners. This difference was mainly caused by the different sequences used on these scanners. The SNR for phantom scans was closely correlated with the SNR from volunteers. Nearly all of the phantom measurements with artifact-free images were above the alarm threshold, suggesting that the scanners are stable longitudinally. Software upgrades and hardware replacement sometimes affected SNR substantially but sometimes did not. In light of these results, it is important to monitor longitudinal SNR with phantom QA to help interpret potential effects on in vivo measurements. Our phantom QA procedure for HARDI scans was successful in tracking scanner performance and detecting unwanted artifacts. PMID:27587227

End of life care for frail older patients in family practice (ELFOP)--protocol of a longitudinal qualitative study on needs, appropriateness and utilisation of services.

PubMed

Müller-Mundt, Gabriele; Bleidorn, Jutta; Geiger, Karin; Klindtworth, Katharina; Pleschberger, Sabine; Hummers-Pradier, Eva; Schneider, Nils

2013-05-03

Frail elderly people represent a major patient group in family practice. Little is known about the patients' needs, and how their needs evolve over time with increasing frailty towards the end of life. This study will address end-of-life care needs, service utilisation, and experiences of frail elderly patients and their informal caregivers, with regard to family practice. This paper aims to introduce the research protocol. The study uses a multiple perspective approach qualitative design. The first study part consists of serial six-monthly in-depth interviews with 30 community-dwelling elderly patients (≥70 years) with moderate to severe frailty and their key informal caregivers, over a period of 18 months. Additionally, semi-structured interviews with the patients' family physician will be conducted. The serial interviews will be analysed with grounded theory and narrative approaches. Special attention will be paid to the comparison of distinct views of the patients', informal caregivers', and family physicians' as well as on chronological aspects. In the second study part, five focus groups with experts in family medicine, geriatrics, palliative medicine, and nursing will be conducted. Finally, the implications for family practice and health care policy will be discussed in an expert workshop. To our knowledge, this is the first prospective, longitudinal qualitative study on the needs of elderly patients with advanced frailty towards the end of life in German family practice, which integrates the perspectives of patients, informal caregivers, family physicians and other health professionals. The study will contribute to the understanding of the clinical, psychosocial and information needs of patients and their caregivers, and of respective changes of experiences and needs along the illness/frailty trajectory including the last phase of life. It will provide an empirical basis for improving patient-centred care for this increasingly relevant target group.

Examining the Interplay of Processes Across Multiple Time-Scales: Illustration With the Intraindividual Study of Affect, Health, and Interpersonal Behavior (iSAHIB).

PubMed

Ram, Nilam; Conroy, David E; Pincus, Aaron L; Lorek, Amy; Rebar, Amanda; Roche, Michael J; Coccia, Michael; Morack, Jennifer; Feldman, Josh; Gerstorf, Denis

Human development is characterized by the complex interplay of processes that manifest at multiple levels of analysis and time-scales. We introduce the Intraindividual Study of Affect, Health and Interpersonal Behavior (iSAHIB) as a model for how multiple time-scale study designs facilitate more precise articulation of developmental theory. Combining age heterogeneity, longitudinal panel, daily diary, and experience sampling protocols, the study made use of smartphone and web-based technologies to obtain intensive longitudinal data from 150 persons age 18-89 years as they completed three 21-day measurement bursts ( t = 426 bursts, t = 8,557 days) wherein they provided reports on their social interactions ( t = 64,112) as they went about their daily lives. We illustrate how multiple time-scales of data can be used to articulate bioecological models of development and the interplay among more 'distal' processes that manifest at 'slower' time-scales (e.g., age-related differences and burst-to-burst changes in mental health) and more 'proximal' processes that manifest at 'faster' time-scales (e.g., changes in context that progress in accordance with the weekly calendar and family influence processes).

[Design and implementation of the ELSA-Brasil biobank: a prospective study in a Brazilian population].

PubMed

Pereira, Alexandre C; Bensenor, Isabela M; Fedeli, Ligia M; Castilhos, Cristina; Vidigal, Pedro G; Maniero, Viviane; Leite, Claudia M; Pimentel, Robercia A; Duncan, Bruce B; Mill, Jose Geraldo; Lotufo, Paulo A

2013-06-01

The Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) is a multicenter prospective cohort of civil servants designed to assess the determinants of chronic diseases, especially cardiovascular diseases and type 2 diabetes. The present article describes the main design and implementation points of the ELSA-Brasil biobank project. Economic, political, logistical and technological aspects of this study are characterized. Additionally, it discusses the final biorepository protocol and the facilities implemented to achieve this objective. The design and implementation process of the ELSA-Brasil biobank took three years to be performed. Both the central and local biobanks were built according to the best biorepository techniques, using different technological solutions for the distinct needs expected in this study.

An unexplored ethical issue in clinical research: disclosure of individual findings in the Creando Posibilidades [Creating Possibilities] study.

PubMed

Stein, Karen Farchaus; Keller, Colleen; Fishstrom, Astrid

2013-06-01

Individual disclosure refers to the presumptive ethical responsibility of an investigator to communicate to a study participant information that was collected as a part of a research study protocol and is specific to the individual. Currently, there are no federal regulatory guidelines specifying the conditions and management of disclosure of health-related individual-specific information. In this report, the authors discuss the challenges associated with individual disclosure in the context of a longitudinal descriptive study. Arguments favoring disclosure and those challenging disclosure as a general ethical duty are presented. Finally, strategies for addressing individual disclosure are discussed using a research exemplar in which risk behaviors related to health outcomes were measured. Copyright © 2013 Wiley Periodicals, Inc.

Health Care Utilization Among Complementary and Alternative Medicine Users in a Large Military Cohort

DTIC Science & Technology

2011-04-11

the Naval Health Research Center (protocol NHRC.2000.0007). Data Sources In addition to our longitudinal survey instrument , other data sources...megavitamin therapy, homeopathic remedies, hypnosis , massage therapy, relaxation, and spiritual healing. For the purposes of these analyses...acupuncture, biofeedback, chiropractic care, energy healing, folk medicine, hypnosis , and massage therapy were grouped together as practitioner-assisted

Longitudinal assessment of mouse renal injury using high-resolution anatomic and magnetization transfer MR imaging.

PubMed

Wang, Feng; Jiang, Rosie; Takahashi, Keiko; Gore, John; Harris, Raymond C; Takahashi, Takamune; Quarles, C Chad

2014-11-01

The purpose of this study is to evaluate the utility of high-resolution non-invasive endogenous high-field MRI methods for the longitudinal structural and quantitative assessments of mouse kidney disease using the model of unilateral ureter obstruction (UUO). T1-weighted, T2-weighted and magnetization transfer (MT) imaging protocols were optimized to improve the regional contrast in mouse kidney. Conventional T1 and T2 weighted images were collected in UUO mice on day 0 (~3h), day 1, day 3 and day 6 after injury, on a 7 T small animal MRI system. Cortical and medullary thickness, corticomedullary contrast and Magnetization Transfer Ratio (MTR) were assessed longitudinally. Masson trichrome staining was used to histologically assess changes in tissue microstructure. Over the course of UUO progression there were significant (p<0.05) changes in thickness of cortex and outer medulla, and regional changes in T2 signal intensity and MTR values. Histological changes included tubular cell death, tubular dilation, urine retention, and interstitial fibrosis, assessed by histology. The MRI measures of renal cortical and medullary atrophy, cortical-medullary differentiation and MTR changes provide an endogenous, non-invasive and quantitative evaluation of renal morphology and tissue composition during UUO progression. Copyright © 2014 Elsevier Inc. All rights reserved.

Carotid intima-media thickness in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil): a narrative review.

PubMed

Santos, Eduardo Henrique Sena; Santos Neto, Pedro José Dos; Santos, Itamar de Souza

2018-01-01

Carotid intima-media thickness (CIMT), as measured by ultrasound, has been used in large studies as a non-invasive marker for subclinical atherosclerosis. The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) is a cohort of 15,105 civil servants in six Brazilian cities that included CIMT evaluation in its baseline assessment. The aim of the present narrative review was to provide an overview of ELSA-Brasil CIMT articles published up to July 31, 2017. Narrative review of ELSA-Brasil CIMT studies using baseline assessment data. We searched PubMed for the terms "ELSA-Brasil" and "intima-media". This search yielded 21 published articles using CIMT data from the ELSA-Brasil baseline assessment, which were included in this review. We also present information about intima-media thickness assessment from ongoing onsite reevaluations of the study participants. Most published studies focused on the association with traditional and novel cardiovascular risk factors. Studies also presented information about the ELSA-Brasil CIMT protocol at baseline and CIMT value distribution in this large sample. Analyses on the ELSA-Brasil data led to important insights on CIMT interpretation and physiology. Besides the highlighted contributions which have already been made in this field, new data gathered during the ongoing third onsite assessment will enable investigation of substantially new research questions.

PRIMARY IMMUNE DEFICIENCY TREATMENT CONSORTIUM (PIDTC) UPDATE

PubMed Central

Griffith, Linda M.; Cowan, Morton J.; Notarangelo, Luigi D.; Kohn, Donald B.; Puck, Jennifer M.; Shearer, William T.; Burroughs, Lauri M.; Torgerson, Troy R.; Decaluwe, Hélène; Haddad, Elie

2016-01-01

The Primary Immune Deficiency Treatment Consortium (PIDTC) is a collaboration of 41 North American centers studying therapy for rare primary immune deficiency diseases (PID) including Severe Combined Immune Deficiency (SCID), Wiskott-Aldrich syndrome (WAS) and chronic granulomatous disease (CGD). An additional 3 European centers have partnered with the PIDTC to study CGD. Natural history protocols of the PIDTC analyze outcomes of treatment for rare PID in multicenter longitudinal retrospective, prospective and cross-sectional studies. Since 2009, participating centers have enrolled over 800 subjects on PIDTC protocols for SCID, and enrollment on the studies in WAS and CGD is underway. Four pilot projects have been funded and 12 junior investigators have received fellowship awards. Important publications of the consortium describe outcomes of hematopoietic cell transplantation (HCT) for SCID during 2000–2009, diagnostic criteria for SCID, and the pilot project of newborn screening (NBS) for SCID in the Navajo Nation. The PIDTC Annual Scientific Workshops provide an opportunity to strengthen collaborations with junior investigators, patient advocacy groups and international colleagues. Funded by the NIAID and ORDR, NCATS, the PIDTC has recently received renewal for another 5 years. Here, we review accomplishments of the group, projects underway, highlights of recent workshops and challenges for the future. PMID:27262745

Protocol of a longitudinal cohort study on physical activity behaviour in physically disabled patients participating in a rehabilitation counselling programme: ReSpAct

PubMed Central

Alingh, Rolinde A; Hoekstra, Femke; van der Schans, Cees P; Hettinga, Florentina J; Dekker, Rienk; van der Woude, Lucas H V

2015-01-01

Introduction Stimulating physical activity behaviour in persons with a physical disability is important, especially after discharge from rehabilitation. A tailored counselling programme covering both the period of the rehabilitation treatment and the first months at home seems on the average effective. However, a considerable variation in response is observed in the sense that some patients show a relevant beneficial response while others show no or only a small response on physical activity behaviour. The Rehabilitation, Sports and Active lifestyle (ReSpAct) study aims to estimate the associations of patient and programme characteristics with patients’ physical activity behaviour after their participation in a tailored counselling programme. Methods and analysis A questionnaire-based nationwide longitudinal prospective cohort study is conducted. Participants are recruited from 18 rehabilitation centres and hospitals in The Netherlands. 2000 participants with a physical disability or chronic disease will be followed during and after their participation in a tailored counselling programme. Programme outcomes on physical activity behaviour and patient as well as programme characteristics that may be associated with differences in physical activity behaviour after programme completion are being assessed. Data collection takes place at baseline and 14, 33 and 52 weeks after discharge from rehabilitation. Ethics and dissemination The study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Groningen and at individual participating institutions. All participants give written informed consent. The study results will provide new insights into factors that may help explain the differences in physical activity behaviour of patients with a physical disability after they have participated in the same physical activity and sports stimulation programme. Thereby, it will support healthcare professionals to tailor their guidance and care to individual patients in order to stimulate physical activity after discharge in a more efficient and effective way. Trial registration number NTR3961. PMID:25633288

Longitudinal cohort protocol study of oropharyngeal dysphagia: relationships to gross motor attainment, growth and nutritional status in preschool children with cerebral palsy

PubMed Central

Benfer, Katherine A; Weir, Kelly A; Bell, Kristie L; Ware, Robert S; Davies, Peter S W; Boyd, Roslyn N

2012-01-01

Introduction The prevalence of oropharyngeal dysphagia (OPD) in children with cerebral palsy (CP) is estimated to be between 19% and 99%. OPD can impact on children's growth, nutrition and overall health. Despite the growing recognition of the extent and significance of health issues relating to OPD in children with CP, lack of knowledge of its profile in this subpopulation remains. This study aims to investigate the relationship between OPD, attainment of gross motor skills, growth and nutritional status in young children with CP at and between two crucial age points, 18–24 and 36 months, corrected age. Methods and analysis This prospective longitudinal population-based study aims to recruit a total of 200 children with CP born in Queensland, Australia between 1 September 2006 and 31 December 2009 (60 per birth-year). Outcomes include clinically assessed OPD (Schedule for Oral Motor Assessment, Dysphagia Disorders Survey, Pre-Speech Assessment Scale, signs suggestive of pharyngeal phase impairment, Thomas-Stonell and Greenberg Saliva Severity Scale), parent-reported OPD on a feeding questionnaire, gross motor skills (Gross Motor Function Measure, Gross Motor Function Classification System and motor type), growth and nutritional status (linear growth and body composition) and dietary intake (3 day food record). The strength of relationship between outcome and exposure variables will be analysed using regression modelling with ORs and relative risk ratios. Ethics and dissemination This protocol describes a study that provides the first large population-based study of OPD in a representative sample of preschool children with CP, using direct clinical assessment. Ethics has been obtained through the University of Queensland Medical Research Ethics Committee, the Children's Health Services District Ethics Committee, and at other regional and organisational ethics committees. Results are planned to be disseminated in six papers submitted to peer reviewed journals, and presentations at relevant international conferences. PMID:22893668

Robotic set-up to quantify hand-eye behavior in motor execution and learning of children with autism spectrum disorder.

PubMed

Casellato, Claudia; Gandolla, Marta; Crippa, Alessandro; Pedrocchi, Alessandra

2017-07-01

Autism spectrum disorder (ASD) is a multifaceted neurodevelopmental disorder characterized by a persistence of social and communication impairment, and restricted and repetitive behaviors. However, motor disorders have also been described, but not objectively assessed. Most studies showed inefficient eye-hand coordination and motor learning in children with ASD; in other experiments, mechanisms of acquisition of internal models in self-generated movements appeared to be normal in autism. In this framework, we have developed a robotic protocol, recording gaze and hand data during upper limb tasks, in which a haptic pen-like handle is moved along specific trajectories displayed on the screen. The protocol includes trials of reaching under a perturbing force field and catching moving targets, with or without visual availability of the whole path. We acquired 16 typically-developing scholar-age children and one child with ASD as a case study. Speed-accuracy tradeoff, motor performance, and gaze-hand spatial coordination have been evaluated. Compared to typically developing peers, in the force field sequence, the child with ASD showed an intact but delayed learning, and more variable gazehand patterns. In the catching trials, he showed less efficient movements, but an intact capability of exploiting the available a-priori plan. The proposed protocol represents a powerful tool, easily tunable, for quantitative (longitudinal) assessment, and for subject-tailored training in ASD.

The Alzheimer's Disease Neuroimaging Initiative (ADNI): MRI Methods

PubMed Central

Jack, Clifford R.; Bernstein, Matt A.; Fox, Nick C.; Thompson, Paul; Alexander, Gene; Harvey, Danielle; Borowski, Bret; Britson, Paula J.; Whitwell, Jennifer L.; Ward, Chadwick; Dale, Anders M.; Felmlee, Joel P.; Gunter, Jeffrey L.; Hill, Derek L.G.; Killiany, Ron; Schuff, Norbert; Fox-Bosetti, Sabrina; Lin, Chen; Studholme, Colin; DeCarli, Charles S.; Krueger, Gunnar; Ward, Heidi A.; Metzger, Gregory J.; Scott, Katherine T.; Mallozzi, Richard; Blezek, Daniel; Levy, Joshua; Debbins, Josef P.; Fleisher, Adam S.; Albert, Marilyn; Green, Robert; Bartzokis, George; Glover, Gary; Mugler, John; Weiner, Michael W.

2008-01-01

The Alzheimer's Disease Neuroimaging Initiative (ADNI) is a longitudinal multisite observational study of healthy elders, mild cognitive impairment (MCI), and Alzheimer's disease. Magnetic resonance imaging (MRI), (18F)-fluorode-oxyglucose positron emission tomography (FDG PET), urine serum, and cerebrospinal fluid (CSF) biomarkers, as well as clinical/psychometric assessments are acquiredat multiple time points. All data will be cross-linked and made available to the general scientific community. The purpose of this report is to describe the MRI methods employed in ADNI. The ADNI MRI core established specifications thatguided protocol development. A major effort was devoted toevaluating 3D T1-weighted sequences for morphometric analyses. Several options for this sequence were optimized for the relevant manufacturer platforms and then compared in a reduced-scale clinical trial. The protocol selected for the ADNI study includes: back-to-back 3D magnetization prepared rapid gradient echo (MP-RAGE) scans; B1-calibration scans when applicable; and an axial proton density-T2 dual contrast (i.e., echo) fast spin echo/turbo spin echo (FSE/TSE) for pathology detection. ADNI MRI methods seek to maximize scientific utility while minimizing the burden placed on participants. The approach taken in ADNI to standardization across sites and platforms of the MRI protocol, postacquisition corrections, and phantom-based monitoring of all scanners could be used as a model for other multisite trials. PMID:18302232

Cardio-autonomic control and wellbeing due to oscillating color light exposure.

PubMed

Grote, Vincent; Kelz, Christina; Goswami, Nandu; Stossier, Harald; Tafeit, Erwin; Moser, Maximilian

2013-04-10

We investigated the cardio-autonomic and psychological effects of colored light cycling with the wavelength of ultradian rhythms. In two consecutive experiments, an explorative, longitudinal test followed by a randomized crossover design, 20 healthy subjects each were exposed to oscillating red, green and blue light. Heart rate, heart rate variability (HRV) and subjective wellbeing were measured. Significant effects of the oscillating color light exposure were observed for heart rate and cardio-autonomic control rhythms, derived from HRV (p≤.001). These effects on HRV were replicated in the second experiment in comparison to a similar white light exposure protocol (p≤.05). Vigilance showed improvement over the two weeks (p≤.001) in the longitudinal study. External color light cycling at the wavelength of blood pressure oscillations appears to amplify the endogenous autonomic oscillations. This leads to an optimization of cardio-autonomic control; an effect that was reflected shortly after the onset of the light exposure sessions by the increase of heart rate variability. From the results, we conclude that it takes repeated light exposure session to foster the positive effects on the psychological aspects, as we observed an increase of subjectively perceived mood only in the longitudinal study, not for the crossover design study. The results of our study imply some possible health effects of a color light exposure that is adjusted to 10 s and 1 min oscillations of humans' ultradian rhythms. These novel results show possible applications of oscillating visual inputs to the activation of processes connected to physiological regulation. Copyright © 2013 Elsevier Inc. All rights reserved.

Longitudinal evaluation of dementia care in German nursing homes: the “DemenzMonitor” study protocol

PubMed Central

2013-01-01

Background In Germany, the number of people with dementia living in nursing homes is rapidly increasing. Providing adequate care for their special needs is a challenge for institutions and their staff members. Because of the growing number of people with dementia, changes to the conceptual orientation of nursing homes have occurred. These changes include specialized living arrangements and psychosocial interventions recommended for people with dementia. Until now, the provision of dementia care and its association to the residents’ behavior and quality of life is not well investigated in Germany. The purpose of this study is to describe the provision of dementia care and to identify resident- as well as facility-related factors associated with residents behavior and quality of life. Methods/Design The DemenzMonitor study is designed as a longitudinal study that is repeated annually. Data will be derived from a convenience sample consisting of nursing homes across Germany. For the data collection, three questionnaires have been developed that measure information on the level of the nursing home, the living units, and the residents. Data collection will be performed by staff members from the nursing homes. The data collection procedure will be supervised by a study coordinator who is trained by the research team. Data analysis will be performed on each data level using appropriate techniques for descriptions and comparisons as well as longitudinal regression analysis. Discussion The DemenzMonitor is the first study in Germany that assesses how dementia care is provided in nursing homes with respect to living arrangements and recommended interventions. This study links the acquired data with residents’ outcome measurements, making it possible to evaluate different aspects and concepts of care. PMID:24237990

Adaptability and reproducibility of a memory disruption rTMS protocol in the PharmaCog IMI European project.

PubMed

Martin-Trias, Pablo; Lanteaume, Laura; Solana, Elisabeth; Cassé-Perrot, Catherine; Fernández-Cabello, Sara; Babiloni, Claudio; Marzano, Nicola; Junqué, Carme; Rossini, Paolo Maria; Micallef, Joëlle; Truillet, Romain; Charles, Estelle; Jouve, Elisabeth; Bordet, Régis; Santamaria, Joan; Jovicich, Jorge; Rossi, Simone; Pascual-Leone, Alvaro; Blin, Olivier; Richardson, Jill; Bartrés-Faz, David

2018-06-19

Transcranial magnetic stimulation (TMS) can interfere with cognitive processes, such as transiently impairing memory. As part of a multi-center European project, we investigated the adaptability and reproducibility of a previously published TMS memory interfering protocol in two centers using EEG or fMRI scenarios. Participants were invited to attend three experimental sessions on different days, with sham repetitive TMS (rTMS) applied on day 1 and real rTMS on days 2 and 3. Sixty-eight healthy young men were included. On each experimental day, volunteers were instructed to remember visual pictures while receiving neuronavigated rTMS trains (20 Hz, 900 ms) during picture encoding at the left dorsolateral prefrontal cortex (L-DLPFC) and the vertex. Mixed ANOVA model analyses were performed. rTMS to the L-DLPFC significantly disrupted recognition memory on experimental day 2. No differences were found between centers or between fMRI and EEG recordings. Subjects with lower baseline memory performances were more susceptible to TMS disruption. No stability of TMS-induced memory interference could be demonstrated on day 3. Our data suggests that adapted cognitive rTMS protocols can be implemented in multi-center studies incorporating standardized experimental procedures. However, our center and modality effects analyses lacked sufficient statistical power, hence highlighting the need to conduct further studies with larger samples. In addition, inter and intra-subject variability in response to TMS might limit its application in crossover or longitudinal studies.

A protocol for a new methodological model for work-related shoulder complex injuries: From diagnosis to rehabilitation.

PubMed

Setuain, Igor; Gonzalez-Izal, Miriam; Paularena, Ainara; Luque, Jose Luis; Andersen, Lars L; Izquierdo, Mikel

2017-02-07

Work-related injuries of the shoulder complex represent a challenge for clinicians because of the large variety of clinical entities involved and the broad anatomic structures that can be affected. Furthermore, commonly performed orthopedic tests have demonstrated limited accuracy for diagnosing the injury despite considerable research efforts. The aim of this study protocol is therefore to describe a comprehensive approach integrating both a clinical- and functional status-based pathology and an adapted rehabilitation prescription. A longitudinal cohort study will be performed at the Department of Rehabilitation and Medical Assistance of a mutual insurance society for work-related injury management in Spain (Mutua Navarra, Pamplona, Navarra Spain). Patients will be attended by an occupational physician who specializes in work-related injuries and is part of the project team that will systematically visit all the participants. After the medical diagnosis and any requested supplementary evaluations (i.e., radiological examinations), the patients will be referred to the rehabilitation service. Before the physiotherapeutic rehabilitation program is initiated, the patients will undergo a comprehensive functional screening at the biomechanics laboratory. Using a decision-making scheme, the identified functional deficits will be used to customize the individual rehabilitation plan. The proposed objective criteria-based shoulder diagnosis and rehabilitation model could be a new effective strategy for minimizing the time required to regain functional capacity and recover from symptoms among patients with work-related shoulder injuries. The study protocol has been registered on Clinical Trials.gov as NCT02732002 (April 10 th 2016).

Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.

PubMed

Lernmark, Barbro; Lynch, Kristian; Baxter, Judith; Roth, Roswith; Simell, Tuula; Smith, Laura; Swartling, Ulrica; Johnson, Suzanne Bennett

2016-01-01

To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.

A place to call home: study protocol for a longitudinal, mixed methods evaluation of two housing first adaptations in Sydney, Australia.

PubMed

Whittaker, Elizabeth; Swift, Wendy; Flatau, Paul; Dobbins, Timothy; Schollar-Root, Olivia; Burns, Lucinda

2015-04-09

This protocol describes a study evaluating two 'Housing First' programs, Platform 70 and Common Ground, presently being implemented in the inner-city region of Sydney, Australia. The Housing First approach prioritises housing individuals who are homeless in standard lease agreement tenancies as rapidly as possible to lock in the benefits from long-term accommodation, even where the person may not be seen as 'housing ready'. The longitudinal, mixed methods evaluation utilises both quantitative and qualitative data collected at baseline and 12-month follow-up time points. For the quantitative component, clients of each program were invited to complete client surveys that reported on several factors associated with chronic homelessness and were hypothesised to improve under stable housing, including physical and mental health status and treatment rates, quality of life, substance use patterns, and contact with the health and criminal justice systems. Semi-structured interviews with clients and stakeholders comprised the qualitative component and focused on individual experiences with, and perceptions of, the two programs. In addition, program data on housing stability, rental subsidies and support levels provided to clients by agencies was collected and will be used in conjunction with the client survey data to undertake an economic evaluation of the two programs. This study will systematically evaluate the efficacy of a scatter site model (Platform 70) and a congregated model (Common Ground) of the Housing First approach; an examination that has not yet been made either in Australia or internationally. A clear strength of the study is its timing. It was designed and implemented as the programs in question themselves were introduced. Moreover, the programs were introduced when the Australian Government, with State and Territory support, began a more focused, coordinated response to homelessness and funded rapid expansion of innovative homelessness programs across the country, including Common Ground supportive housing developments.

Lifestyle in Multiple Myeloma - a longitudinal cohort study protocol.

PubMed

Heinrich, M; Fisher, A; Paton, B; McCourt, O; Beeken, R J; Hackshaw, A; Wardle, J; Yong, K

2016-07-04

Deterioration in bone health is one of the presenting symptoms of Multiple Myeloma (MM), a cancer of plasma cells. As a consequence of this condition, patients suffer bone pain and bone damage and report cancer-related fatigue, resulting in deterioration in their quality of life. Evidence in patients with solid tumours shows promise for the positive effects of physical activity on quality of life. However, in the case of patients with MM a better understanding of the association between physical fitness and quality of life factors is still required. Therefore, this cohort study aims to objectively and longitudinally assess activity and fitness levels in patients with MM in order to explore their role in bone health, fatigue and quality of life for this patient population. The study is a prospective cohort study of MM patients in remission to assess physical activity, fatigue and bone health. Clinical markers of health, self-reported measures of psychological and physical well-being, and lifestyle behaviours are assessed at baseline, 3, 6 and 12 months. At each time point, patients complete cardiopulmonary exercise testing (CPET) along with a series of objective tests to assess physical fitness (eg accelerometry) and a number of self-report measures. A complementary qualitative study will be carried out in order to explore patients' desire for lifestyle advice and when in their cancer journey they deem such advice to be useful. This study will be the first to prospectively and longitudinally explore associations between physical fitness and well-being, bone health, and fatigue (along with a number of other physical and clinical outcomes) in a cohort of patients with MM with the use of objective measures. The findings will also help to identify time points within the MM pathway at which physical activity interventions may be introduced for maximum benefit.

The utility of micro-CT and MRI in the assessment of longitudinal growth of liver metastases in a preclinical model of colon carcinoma.

PubMed

Pandit, Prachi; Johnston, Samuel M; Qi, Yi; Story, Jennifer; Nelson, Rendon; Johnson, G Allan

2013-04-01

Liver is a common site for distal metastases in colon and rectal cancer. Numerous clinical studies have analyzed the relative merits of different imaging modalities for detection of liver metastases. Several exciting new therapies are being investigated in preclinical models. But, technical challenges in preclinical imaging make it difficult to translate conclusions from clinical studies to the preclinical environment. This study addresses the technical challenges of preclinical magnetic resonance imaging (MRI) and micro-computed tomography (CT) to enable comparison of state-of-the-art methods for following metastatic liver disease. We optimized two promising preclinical protocols to enable a parallel longitudinal study tracking metastatic human colon carcinoma growth in a mouse model: T2-weighted MRI using two-shot PROPELLER (Periodically Rotated Overlapping ParallEL Lines with Enhanced Reconstruction) and contrast-enhanced micro-CT using a liposomal contrast agent. Both methods were tailored for high throughput with attention to animal support and anesthesia to limit biological stress. Each modality has its strengths. Micro-CT permitted more rapid acquisition (<10 minutes) with the highest spatial resolution (88-micron isotropic resolution). But detection of metastatic lesions requires the use of a blood pool contrast agent, which could introduce a confound in the evaluation of new therapies. MRI was slower (30 minutes) and had lower anisotropic spatial resolution. But MRI eliminates the need for a contrast agent and the contrast-to-noise between tumor and normal parenchyma was higher, making earlier detection of small lesions possible. Both methods supported a relatively high-throughput, longitudinal study of the development of metastatic lesions. Copyright © 2013 AUR. Published by Elsevier Inc. All rights reserved.

Understanding developmental language disorder - the Helsinki longitudinal SLI study (HelSLI): a study protocol.

PubMed

Laasonen, Marja; Smolander, Sini; Lahti-Nuuttila, Pekka; Leminen, Miika; Lajunen, Hanna-Reetta; Heinonen, Kati; Pesonen, Anu-Katriina; Bailey, Todd M; Pothos, Emmanuel M; Kujala, Teija; Leppänen, Paavo H T; Bartlett, Christopher W; Geneid, Ahmed; Lauronen, Leena; Service, Elisabet; Kunnari, Sari; Arkkila, Eva

2018-05-21

Developmental language disorder (DLD, also called specific language impairment, SLI) is a common developmental disorder comprising the largest disability group in pre-school-aged children. Approximately 7% of the population is expected to have developmental language difficulties. However, the specific etiological factors leading to DLD are not yet known and even the typical linguistic features appear to vary by language. We present here a project that investigates DLD at multiple levels of analysis and aims to make the reliable prediction and early identification of the difficulties possible. Following the multiple deficit model of developmental disorders, we investigate the DLD phenomenon at the etiological, neural, cognitive, behavioral, and psychosocial levels, in a longitudinal study of preschool children. In January 2013, we launched the Helsinki Longitudinal SLI study (HelSLI) at the Helsinki University Hospital ( http://tiny.cc/HelSLI ). We will study 227 children aged 3-6 years with suspected DLD and their 160 typically developing peers. Five subprojects will determine how the child's psychological characteristics and environment correlate with DLD and how the child's well-being relates to DLD, the characteristics of DLD in monolingual versus bilingual children, nonlinguistic cognitive correlates of DLD, electrophysiological underpinnings of DLD, and the role of genetic risk factors. Methods include saliva samples, EEG, computerized cognitive tasks, neuropsychological and speech and language assessments, video-observations, and questionnaires. The project aims to increase our understanding of the multiple interactive risk and protective factors that affect the developing heterogeneous cognitive and behavioral profile of DLD, including factors affecting literacy development. This accumulated knowledge will form a heuristic basis for the development of new interventions targeting linguistic and non-linguistic aspects of DLD.

Neuropsychiatric and cardiometabolic comorbidities in patients with previously diagnosed Cushing's disease: a longitudinal observational study

PubMed Central

Dimopoulou, C; Geraedts, V; Stalla, G K; Sievers, C

2015-01-01

Introduction Only few studies have systematically investigated neuropsychiatric aspects in patients with Cushing's disease (CD). Pain syndromes have been described in patients with pituitary adenomas, but so far no systematical investigation has been conducted in patients with CD. Additionally, CD has an association with cardiometabolic comorbidities which ultimately leads to increased morbidity and mortality. Long-term treatment of the hypercortisolic state cannot prevent the persistence of an unfavourable cardiometabolic risk profile. Finally, chronic hypercortisolism is known to impact the health-related quality of life (HRQoL). We aim to systematically investigate the neuropsychiatric and cardiometabolic comorbidities, as well as assess the HRQoL, in patients with previously diagnosed CD in a longitudinal fashion. Methods and analysis In this longitudinal study, we will assess 20 patients with CD displaying biochemical control 24 months after recruitment in the initial cross-sectional study (n=80). This will be a mixed cohort including patients after surgical, after radiation therapy and/or under current medical treatment for CD. Primary outcomes include changes in mean urinary free cortisol and changes in specific pain patterns. Secondary/exploratory neuropsychiatric domains include depression, anxiety, personality, sleep, body image and quality of life. Secondary/exploratory cardiometabolic domains include anthropometric parameters, cardiometabolic risk biomarkers and insulin resistance. Additional domains will be investigated if warranted by clinical indication. Safety assessment under medical therapy will include liver enzymes, ECG abnormalities and hyperglycaemia. Ethics and dissemination Risk of damage from study-conditioned measures is very small and considered ethically justified. Dual-energy X-ray absorptiometry may call for detailed fracture risk assessment. However, the radiation dose is very small and only administered on clinical indication; therefore, it is considered ethically justified. This protocol has been approved by the local medical ethics committee. PMID:25818269

Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis.

PubMed

Belkin, Amanda; Fier, Kaitlin; Albright, Karen; Baird, Susan; Crowe, Brenda; Eres, Linda; Korn, Marjorie; Maginn, Leslie; McCormick, Mark; Root, Elisabeth D; Vierzba, Thomas; Wamboldt, Frederick S; Swigris, Jeffrey J

2014-11-01

Little is known about whether or how supplemental oxygen affects patients with pulmonary fibrosis. A mixed-methods study is described. Patients with pulmonary fibrosis, informal caregivers of pulmonary fibrosis patients and practitioners who prescribe supplemental oxygen will be interviewed to gather data on perceptions of how supplemental oxygen impacts patients. In addition, three hundred pulmonary fibrosis patients who do not use daytime supplemental oxygen will be recruited to participate in a longitudinal, pre-/post- study in which patient-reported outcome (PRO) and activity data will be collected at baseline, immediately before daytime supplemental oxygen is initiated, and then once and again 9-12 months later. Activity data will be collected using accelerometers and portable GPS data recorders. The primary outcome is change in dyspnea from before to one month after supplemental oxygen is initiated. Secondary outcomes include scores from PROs to assess cough, fatigue and quality of life as well as the activity data. In exploratory analyses, we will use longitudinal data analytic techniques to assess the trajectories of outcomes over time while controlling for potentially influential variables. Throughout the study and at its completion, results will be posted on the website for our research program (the Participation Program for Pulmonary Fibrosis or P3F) at http://www.pulmonaryfibrosisresearch.org.

Update on the MRI Core of the Alzheimer's Disease Neuroimaging Initiative

PubMed Central

Jack, Clifford R; Bernstein, Matt A; Borowski, Bret J; Gunter, Jeffrey L; Fox, Nick C; Thompson, Paul M; Schuff, Norbert; Krueger, Gunnar; Killiany, Ronald J; DeCarli, Charles S; Dale, Anders M; Weiner, Michael W

2010-01-01

Functions of the ADNI MRI core fall into three categories: (1) those of the central MRI core lab at Mayo Clinic, Rochester, Minnesota, needed to generate high quality MRI data in all subjects at each time point; (2) those of the funded ADNI MRI core imaging analysis groups responsible for analyzing the MRI data, and (3) the joint function of the entire MRI core in designing and problem solving MR image acquisition, pre-processing and analyses methods. The primary objective of ADNI was and continues to be improving methods for clinical trials in Alzheimer's disease. Our approach to the present (“ADNI-GO”) and future (“ADNI-2”, if funded) MRI protocol will be to maintain MRI methodological consistency in previously enrolled “ADNI-1” subjects who are followed longitudinally in ADNI-GO and ADNI-2. We will modernize and expand the MRI protocol for all newly enrolled ADNI-GO and ADNI-2 subjects. All newly enrolled subjects will be scanned at 3T with a core set of three sequence types: 3D T1-weighted volume, FLAIR, and a long TE gradient echo volumetric acquisition for micro hemorrhage detection. In addition to this core ADNI-GO and ADNI-2 protocol, we will perform vendor specific pilot sub-studies of arterial spin labeling perfusion, resting state functional connectivity and diffusion tensor imaging. One each of these sequences will be added to the core protocol on systems from each MRI vendor. These experimental sub-studies are designed to demonstrate the feasibility of acquiring useful data in a multi-center (but single vendor) setting for these three emerging MRI applications. PMID:20451869

Update on the magnetic resonance imaging core of the Alzheimer's disease neuroimaging initiative.

PubMed

Jack, Clifford R; Bernstein, Matt A; Borowski, Bret J; Gunter, Jeffrey L; Fox, Nick C; Thompson, Paul M; Schuff, Norbert; Krueger, Gunnar; Killiany, Ronald J; Decarli, Charles S; Dale, Anders M; Carmichael, Owen W; Tosun, Duygu; Weiner, Michael W

2010-05-01

Functions of the Alzheimer's Disease Neuroimaging Initiative (ADNI) magnetic resonance imaging (MRI) core fall into three categories: (1) those of the central MRI core laboratory at Mayo Clinic, Rochester, Minnesota, needed to generate high quality MRI data in all subjects at each time point; (2) those of the funded ADNI MRI core imaging analysis groups responsible for analyzing the MRI data; and (3) the joint function of the entire MRI core in designing and problem solving MR image acquisition, pre-processing, and analyses methods. The primary objective of ADNI was and continues to be improving methods for clinical trials in Alzheimer's disease. Our approach to the present ("ADNI-GO") and future ("ADNI-2," if funded) MRI protocol will be to maintain MRI methodological consistency in the previously enrolled "ADNI-1" subjects who are followed up longitudinally in ADNI-GO and ADNI-2. We will modernize and expand the MRI protocol for all newly enrolled ADNI-GO and ADNI-2 subjects. All newly enrolled subjects will be scanned at 3T with a core set of three sequence types: 3D T1-weighted volume, FLAIR, and a long TE gradient echo volumetric acquisition for micro hemorrhage detection. In addition to this core ADNI-GO and ADNI-2 protocol, we will perform vendor-specific pilot sub-studies of arterial spin-labeling perfusion, resting state functional connectivity, and diffusion tensor imaging. One of these sequences will be added to the core protocol on systems from each MRI vendor. These experimental sub-studies are designed to demonstrate the feasibility of acquiring useful data in a multicenter (but single vendor) setting for these three emerging MRI applications. Copyright 2010 The Alzheimer

Addressing Methodological Challenges in Large Communication Data Sets: Collecting and Coding Longitudinal Interactions in Home Hospice Cancer Care.

PubMed

Reblin, Maija; Clayton, Margaret F; John, Kevin K; Ellington, Lee

2016-07-01

In this article, we present strategies for collecting and coding a large longitudinal communication data set collected across multiple sites, consisting of more than 2000 hours of digital audio recordings from approximately 300 families. We describe our methods within the context of implementing a large-scale study of communication during cancer home hospice nurse visits, but this procedure could be adapted to communication data sets across a wide variety of settings. This research is the first study designed to capture home hospice nurse-caregiver communication, a highly understudied location and type of communication event. We present a detailed example protocol encompassing data collection in the home environment, large-scale, multisite secure data management, the development of theoretically-based communication coding, and strategies for preventing coder drift and ensuring reliability of analyses. Although each of these challenges has the potential to undermine the utility of the data, reliability between coders is often the only issue consistently reported and addressed in the literature. Overall, our approach demonstrates rigor and provides a "how-to" example for managing large, digitally recorded data sets from collection through analysis. These strategies can inform other large-scale health communication research.

Addressing Methodological Challenges in Large Communication Datasets: Collecting and Coding Longitudinal Interactions in Home Hospice Cancer Care

PubMed Central

Reblin, Maija; Clayton, Margaret F; John, Kevin K; Ellington, Lee

2015-01-01

In this paper, we present strategies for collecting and coding a large longitudinal communication dataset collected across multiple sites, consisting of over 2000 hours of digital audio recordings from approximately 300 families. We describe our methods within the context of implementing a large-scale study of communication during cancer home hospice nurse visits, but this procedure could be adapted to communication datasets across a wide variety of settings. This research is the first study designed to capture home hospice nurse-caregiver communication, a highly understudied location and type of communication event. We present a detailed example protocol encompassing data collection in the home environment, large-scale, multi-site secure data management, the development of theoretically-based communication coding, and strategies for preventing coder drift and ensuring reliability of analyses. Although each of these challenges have the potential to undermine the utility of the data, reliability between coders is often the only issue consistently reported and addressed in the literature. Overall, our approach demonstrates rigor and provides a “how-to” example for managing large, digitally-recorded data sets from collection through analysis. These strategies can inform other large-scale health communication research. PMID:26580414

SALGOT - Stroke Arm Longitudinal study at the University of Gothenburg, prospective cohort study protocol

PubMed Central

2011-01-01

Background Recovery patterns of upper extremity motor function have been described in several longitudinal studies, but most of these studies have had selected samples, short follow up times or insufficient outcomes on motor function. The general understanding is that improvements in upper extremity occur mainly during the first month after the stroke incident and little if any, significant recovery can be gained after 3-6 months. The purpose of this study is to describe the recovery of upper extremity function longitudinally in a non-selected sample initially admitted to a stroke unit with first ever stroke, living in Gothenburg urban area. Methods/Design A sample of 120 participants with a first-ever stroke and impaired upper extremity function will be consecutively included from an acute stroke unit and followed longitudinally for one year. Assessments are performed at eight occasions: at day 3 and 10, week 3, 4 and 6, month 3, 6 and 12 after onset of stroke. The primary clinical outcome measures are Action Research Arm Test and Fugl-Meyer Assessment for Upper Extremity. As additional measures, two new computer based objective methods with kinematic analysis of arm movements are used. The ABILHAND questionnaire of manual ability, Stroke Impact Scale, grip strength, spasticity, pain, passive range of motion and cognitive function will be assessed as well. At one year follow up, two patient reported outcomes, Impact on Participation and Autonomy and EuroQol Quality of Life Scale, will be added to cover the status of participation and aspects of health related quality of life. Discussion This study comprises a non-selected population with first ever stroke and impaired arm function. Measurements are performed both using traditional clinical assessments as well as computer based measurement systems providing objective kinematic data. The ICF classification of functioning, disability and health is used as framework for the selection of assessment measures. The study design with several repeated measurements on motor function will give us more confident information about the recovery patterns after stroke. This knowledge is essential both for optimizing rehabilitation planning as well as providing important information to the patient about the recovery perspectives. Trial registration ClinicalTrials.gov: NCT01115348 PMID:21612620

Implementation of the guidelines for targeted temperature management after cardiac arrest: a longitudinal qualitative study of barriers and facilitators perceived by hospital resuscitation champions.

PubMed

Kim, Young-Min; Lee, Seung Joon; Jo, Sun Jin; Park, Kyu Nam

2016-01-05

To identify the barriers to and facilitators of implementing guidelines for targeted temperature management (TTM) after cardiac arrest perceived by hospital resuscitation champions and to investigate the changes in their perceptions over the early implementation period. A longitudinal qualitative study (up to 2 serial semistructured interviews over 1 year and focus groups). The individual interviews and focus groups were transcribed and coded by 2 independent assessors. Contents were analysed thematically; group interaction was also examined. 21 hospitals, including community and tertiary care centres in South Korea. 21 hospital champions (14 acting champions and 7 managerial champions). The final data set included 40 interviews and 2 focus groups. The identified barriers and facilitators could be classified into 3 major themes: (1) healthcare professionals' perceptions of the guidelines and protocols, (2) interdisciplinary and interprofessional collaboration and (3) organisational resources. Lack of resources was the most commonly agreed on barrier for the acting champions, whereas lack of interdisciplinary collaboration was the most common barrier for the managerial champions. Educational activities and sharing successfully treated cases were the most frequently identified facilitators. Most of the participants identified and agreed that cooling equipment was an important barrier as well as a facilitator of successful TTM implementation. Perception of the guidelines and protocols has improved with the accumulation of clinical experience over the study period. Healthcare professionals' internal barriers to TTM implementation may be influenced by new guidelines and can be changed with the accumulation of successful clinical experiences during the early implementation period. Promoting interprofessional and interdisciplinary collaboration through educational activities and the use of cooling equipment with an automated feedback function can improve adherence to guidelines in hospitals with limited human resources in critical care. 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/

Implementation of the guidelines for targeted temperature management after cardiac arrest: a longitudinal qualitative study of barriers and facilitators perceived by hospital resuscitation champions

PubMed Central

Kim, Young-Min; Lee, Seung Joon; Jo, Sun Jin; Park, Kyu Nam

2016-01-01

Objectives To identify the barriers to and facilitators of implementing guidelines for targeted temperature management (TTM) after cardiac arrest perceived by hospital resuscitation champions and to investigate the changes in their perceptions over the early implementation period. Design A longitudinal qualitative study (up to 2 serial semistructured interviews over 1 year and focus groups). The individual interviews and focus groups were transcribed and coded by 2 independent assessors. Contents were analysed thematically; group interaction was also examined. Setting 21 hospitals, including community and tertiary care centres in South Korea. Participants 21 hospital champions (14 acting champions and 7 managerial champions). Results The final data set included 40 interviews and 2 focus groups. The identified barriers and facilitators could be classified into 3 major themes: (1) healthcare professionals’ perceptions of the guidelines and protocols, (2) interdisciplinary and interprofessional collaboration and (3) organisational resources. Lack of resources was the most commonly agreed on barrier for the acting champions, whereas lack of interdisciplinary collaboration was the most common barrier for the managerial champions. Educational activities and sharing successfully treated cases were the most frequently identified facilitators. Most of the participants identified and agreed that cooling equipment was an important barrier as well as a facilitator of successful TTM implementation. Perception of the guidelines and protocols has improved with the accumulation of clinical experience over the study period. Conclusions Healthcare professionals’ internal barriers to TTM implementation may be influenced by new guidelines and can be changed with the accumulation of successful clinical experiences during the early implementation period. Promoting interprofessional and interdisciplinary collaboration through educational activities and the use of cooling equipment with an automated feedback function can improve adherence to guidelines in hospitals with limited human resources in critical care. PMID:26733568

Risk taking and refusal assertiveness in a longitudinal model of alcohol use among inner-city adolescents.

PubMed

Epstein, J A; Griffin, K W; Botvin, G J

2001-09-01

Risk taking and refusal assertiveness have been shown to be important determinants of adolescent alcohol use. However, it remains unclear whether youth predisposed to risk taking would be less likely to assertively refuse. This study examined the relationships among risk taking, refusal assertiveness, and alcohol use in a sample of inner-city minority students (N = 1,459), using a cross-lagged longitudinal structural equation model. Data collectors administered the questionnaire to students following a standardized protocol during a 40-min class period. Based on the tested model, risk taking was more stable over time than refusal assertiveness. Furthermore, high risk takers reported less frequent subsequent refusal assertiveness, and less frequent refusal assertiveness predicted greater drinking. A predisposition toward risk taking appears to be an enduring characteristic that is associated with low refusal assertiveness and increased alcohol use. These findings suggest that alcohol prevention programs that emphasize refusal skills training may be less effective for high risk takers. But programs that focus on enhancing competence or reducing normative expectations for peer alcohol use might be more effective for high risk-taking youth.

Impact of exercise on fecal and cecal metabolome over aging: a longitudinal study in rats.

PubMed

Deda, Olga; Gika, Helen; Panagoulis, Theodoros; Taitzoglou, Ioannis; Raikos, Nikolaos; Theodoridis, Georgios

2017-01-01

Physical exercise can reduce adverse conditions during aging, while both exercise and aging act as metabolism modifiers. The present study investigates rat fecal and cecal metabolome alterations derived from exercise during rats' lifespan. Groups of rats trained life-long or for a specific period of time were under study. The training protocol consisted of swimming, 15-18 min per day, 3-5 days per week, with load of 4-0% of rat's weight. Fecal samples and cecal extracts were analyzed by targeted and untargeted metabolic profiling methods (GC-MS and LC-MS/MS). Effects of exercise and aging on the rats' fecal and cecal metabolome were observed. Fecal and cecal metabolomics are a promising field to investigate exercise biochemistry and age-related alterations.

Review of guidelines and literature for handling missing data in longitudinal clinical trials with a case study.

PubMed

Liu, M; Wei, L; Zhang, J

2006-01-01

Missing data in clinical trials are inevitable. We highlight the ICH guidelines and CPMP points to consider on missing data. Specifically, we outline how we should consider missing data issues when designing, planning and conducting studies to minimize missing data impact. We also go beyond the coverage of the above two documents, provide a more detailed review of the basic concepts of missing data and frequently used terminologies, and examples of the typical missing data mechanism, and discuss technical details and literature for several frequently used statistical methods and associated software. Finally, we provide a case study where the principles outlined in this paper are applied to one clinical program at protocol design, data analysis plan and other stages of a clinical trial.

The evaluation of a healthcare passport to improve quality of care and communication for people living with dementia (EQuIP): a protocol paper for a qualitative, longitudinal study.

PubMed

Leavey, Gerard; Abbott, Aine; Watson, Max; Todd, Stephen; Coates, Vivien; McIlfactrick, Sonja; McCormack, Brendan; Waterhouse-Bradley, Bethany; Curran, Emma

2016-08-09

There is an urgent need for the development of simple communication tools that convey the strengths, assets, and healthcare needs of people living with dementia. A Healthcare Passport may improve communication with range of health and social support services, enhancing quality and continuity of care, and to permit a consideration of the challenges and how these might be managed effectively and compassionately. This study aims to evaluate the acceptability and use of this type of intervention for people living with dementia and their carers. This is a qualitative longitudinal study informed by a critical realist review. The participants will be individuals identified as having mild-moderate dementia and informal carers. The in-depth interviews will occur at three points over the course of 18 months as they use the passport. This will be supplemented by analysis of the content of the passports and information from health and social care providers on the daily practicalities of using the passport in a range of healthcare settings. By using a critical realist review and a qualitative, longitudinal approach, the study allows for the assessment of a complex intervention in a manner which goes beyond evaluating the basic efficacy of the passport, but looking more deeply at how it worked, for whom, and in what context. It has the potential to develop new data on how interventions improve communication across a range of service providers, while encouraging health and social care professionals to respect and encourage the development of self-management and retention of personhood throughout the progression of life-limiting illnesses.

Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III)

PubMed Central

Turner-Stokes, Lynne; Ashford, Stephen; Jacinto, Jorge; Maisonobe, Pascal; Balcaitiene, Jovita; Fheodoroff, Klemens

2016-01-01

Objectives Describe the rationale and protocol for the Upper Limb International Spasticity (ULIS)-III study, which aims to evaluate the impact of integrated spasticity management, involving multiple botulinum toxin A (BoNT-A) injection cycles and concomitant therapies, on patient-centred goal attainment. Outline novel outcome assessment methods for ULIS-III and report initial evaluation data from goal setting in early stages of the study. Design Large international longitudinal cohort study of integrated upper limb spasticity management, including BoNT-A. Participants and setting ULIS-III is a 2-year study expected to enrol >1000 participants at 58 study centres across 14 countries. Interventions The study design is non-interventional and intended to reflect real-life clinical practice. It will describe injection practices and additional treatment strategies, and record clinical decision-making in a serial approach to long-term spasticity management. Outcome measures ULIS-III will use a goal-directed approach to selection of targeted standardised measures to capture the diversity of presentation, goals and outcomes. ULIS-III will implement the Upper Limb Spasticity Index, a battery of assessments including a structured approach to goal attainment scaling (Goal Attainment Scaling—Evaluation of Outcomes for Upper Limb Spasticity tool), alongside a limited set of standardised measures, chosen according to patients' selected goal areas. Concomitant therapy inputs, patient satisfaction with engagement in goal setting, health economic end points and health-related quality of life data will also be captured. Results of initial evaluation of goal quality Recruitment started in January 2015. By June 2015, 58 sites had been identified and initial data collected for 79 patients across 13 sites in 3 countries. Goal setting data were quality-checked and centres rated on the basis of function-related and Specific, Measurable, Achievable, Realistic, Timed (SMART) characteristics of goal statements. Overall, 11/13 centres achieved the highest rating (A++). Conclusions ULIS-III will provide valuable information regarding treatment of and outcomes from real-life upper limb spasticity management worldwide. Trial registration number NCT02454803; Pre-results. PMID:27315835

A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol.

PubMed

Robert, Glenn B; Anderson, Janet E; Burnett, Susan J; Aase, Karina; Andersson-Gare, Boel; Bal, Roland; Calltorp, Johan; Nunes, Francisco; Weggelaar, Anne-Marie; Vincent, Charles A; Fulop, Naomi J

2011-10-26

although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. in-depth multi-level (macro, meso and micro-system) analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims). the protocol is based on the premise that future research, policy and practice need to address the sociology of improvement in equal measure to the science and technique of improvement, or at least expand the discipline of improvement to include these critical organisational and cultural processes. We define the 'organisational and cultural characteristics associated with better quality of care' in a broad sense that encompasses all the features of a hospital that might be hypothesised to impact upon clinical effectiveness, patient safety and/or patient experience.

Impact of Michelangelo prosthetic hand: Findings from a crossover longitudinal study.

PubMed

Luchetti, Martina; Cutti, Andrea G; Verni, Gennaro; Sacchetti, Rinaldo; Rossi, Nicolino

2015-01-01

This work explores the functional and psychosocial impact of the multigrip Michelangelo (M) prosthetic hand. Transradial myoelectric prosthesis users (6 men, median age: 47 y) participated in a crossover longitudinal study. A multifactorial assessment protocol was applied before the application of M and after 3 mo (functional assessment) and 6 mo (psychosocial assessment) of home use. Functional assessment included both practical tests (i.e., Southampton Hand Assessment Procedure [SHAP], Box and Blocks Test [BBT], and Minnesota Manual Dexterity Test [MMDT]) and self-report functional scales. Psychosocial assessment consisted of a clinical interview and a battery of self-report questionnaires concerning current anxious-depressive symptoms and health-related quality of life, body image concerns, adjustment and satisfaction with prosthesis, social support, coping style, and personality. Increased manual dexterity was observed after 3 mo based on improvements in the SHAP, BBT, and MMDT. Two important themes emerged from the clinical interviews at the 6 mo follow-up: (1) the enhanced functionality and (2) the "like a real hand" aspect of the M, which further increased prosthesis integration to the Self. A few patients expressed concerns about M dimension, noise, and weight. The M appeared to restore hand function and natural appearance. The present findings provide preliminary evidence, and additional studies are needed.

Evaluation of the Methods and Management of Acute Coronary Events (EMMACE)-3: protocol for a longitudinal study.

PubMed

Alabas, O A; West, R M; Gillott, R G; Khatib, R; Hall, A S; Gale, C P

2015-06-23

Patients with cardiovascular disease are living longer and are more frequently accessing healthcare resources. The Evaluation of the Methods and Management of Acute Coronary Events (EMMACE)-3 national study is designed to improve understanding of the effect of quality of care on health-related outcomes for patients hospitalised with acute coronary syndrome (ACS). EMMACE-3 is a longitudinal study of 5556 patients hospitalised with an ACS in England. The study collects repeated measures of health-related quality of life, information about medications and patient adherence profiles, a survey of hospital facilities, and morbidity and mortality data from linkages to multiple electronic health records. Together with EMMACE-3X and EMMACE-4, EMMACE-3 will assimilate detailed information for about 13 000 patients across more than 60 hospitals in England. EMMACE-3 was given a favourable ethical opinion by Leeds (West) Research Ethics committee (REC reference: 10/H131374). On successful application, study data will be shared with academic collaborators. The findings from EMMACE-3 will be disseminated through peer-reviewed publications, at scientific conferences, the media, and through patient and public involvement. ClinicalTrials.gov Identifier: NCT01808027. Information about the study is also available at EMMACE.org. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study.

PubMed

Marthick, Michael; Dhillon, Haryana M; Alison, Jennifer A; Cheema, Birinder S; Shaw, Tim

2018-05-15

Significant benefits accrue from increasing physical activity levels in people with a history of cancer. Physical activity levels can be increased using behavioral change interventions in this population. Access to Web portals and provision of activity monitors to provide feedback may support behavior change by encouraging patient engagement in physical therapy. The Web portal evaluated in this study will provide a system to monitor physical activity and sleep, for use by both clinician and patient, along with symptom and health-related quality of life tracking capabilities. The aim of this study was to outline a protocol for a feasibility study focused on a Web-based portal that provides activity monitoring and personalized messaging to increase physical activity in people with cancer. Using a longitudinal cohort design, people with cancer will be serially allocated to 3 intervention cohorts of 20 participants each and followed for 10 weeks. Cohort 1 will be provided a wearable activity monitor and access to a Web-based portal. Cohort 2 will receive the same content as Cohort 1 and in addition will receive a weekly activity summary message. Cohort 3 will receive the same content as Cohorts 1 and 2 and in addition will receive a personalized weekly coaching message. Feasibility of the use of the portal is the primary outcome. Results are expected in early 2018. Outcome measures will include goal attainment and completion rate. This study will provide information about the feasibility of investigating eHealth initiatives to promote physical activity in people with cancer. RR1-10.2196/9586. ©Michael Marthick, Haryana M Dhillon, Jennifer A Alison, Birinder S Cheema, Tim Shaw. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.05.2018.

Deformable Medical Image Registration: A Survey

PubMed Central

Sotiras, Aristeidis; Davatzikos, Christos; Paragios, Nikos

2013-01-01

Deformable image registration is a fundamental task in medical image processing. Among its most important applications, one may cite: i) multi-modality fusion, where information acquired by different imaging devices or protocols is fused to facilitate diagnosis and treatment planning; ii) longitudinal studies, where temporal structural or anatomical changes are investigated; and iii) population modeling and statistical atlases used to study normal anatomical variability. In this paper, we attempt to give an overview of deformable registration methods, putting emphasis on the most recent advances in the domain. Additional emphasis has been given to techniques applied to medical images. In order to study image registration methods in depth, their main components are identified and studied independently. The most recent techniques are presented in a systematic fashion. The contribution of this paper is to provide an extensive account of registration techniques in a systematic manner. PMID:23739795

The population-based Occupational and Environmental Health Prospective Cohort Study (AMIGO) in The Netherlands.

PubMed

Slottje, Pauline; Yzermans, C Joris; Korevaar, Joke C; Hooiveld, Mariëtte; Vermeulen, Roel C H

2014-11-26

Occupational and environmental exposures remain important modifiable risk factors of public health. Existing cohort studies are often limited by the level of detail of data collected on these factors and health. It is also often assumed that the more healthy group is over-represented in cohort studies, which is of concern for their external validity. In this cohort profile, we describe how we set up the population-based Occupational and Environmental Health Cohort Study (AMIGO) to longitudinally study occupational and environmental determinants of diseases and well-being from a multidisciplinary and life course point of view. Reviewed by the Medical Ethics Research Committee of the University Medical Center Utrecht (protocol 10-268/C). All cohort members participate voluntarily and gave informed consent prior to their inclusion. 14,829 adult cohort members (16% of those invited) consented and filled in the online baseline questionnaire. Determinants include chemical, biological, physical (eg, electromagnetic fields), and psychosocial factors. Priority health outcomes include cancer, neurological, cardiovascular and respiratory diseases and non-specific symptoms. Owing to the recruitment strategy via general practitioners of an established network, we also collect longitudinal data registered in their electronic medical records including symptoms, diagnosis and treatments. Besides the advantage of health outcomes that cannot be easily captured longitudinally by other means, this created a unique opportunity to assess health-related participation bias by comparing general practitioner-registered prevalence rates in the cohort and its source population. We found no indications of such a systematic bias. The major assets of the AMIGO approach are its detailed occupational and environmental determinants in combination with the longitudinal health data registered in general practice besides linkage to cancer and mortality registries and self-reported health. We are now in the phase of prospective follow-up, with the aim of continuing this for as long as possible (20+ years), pending future funding. Findings will be disseminated through scientific conferences and peer-reviewed journals, and through newsletters and the project website to participants, stakeholders and the wider public. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Collaborative SDOCT Segmentation and Analysis Software.

PubMed

Yun, Yeyi; Carass, Aaron; Lang, Andrew; Prince, Jerry L; Antony, Bhavna J

2017-02-01

Spectral domain optical coherence tomography (SDOCT) is routinely used in the management and diagnosis of a variety of ocular diseases. This imaging modality also finds widespread use in research, where quantitative measurements obtained from the images are used to track disease progression. In recent years, the number of available scanners and imaging protocols grown and there is a distinct absence of a unified tool that is capable of visualizing, segmenting, and analyzing the data. This is especially noteworthy in longitudinal studies, where data from older scanners and/or protocols may need to be analyzed. Here, we present a graphical user interface (GUI) that allows users to visualize and analyze SDOCT images obtained from two commonly used scanners. The retinal surfaces in the scans can be segmented using a previously described method, and the retinal layer thicknesses can be compared to a normative database. If necessary, the segmented surfaces can also be corrected and the changes applied. The interface also allows users to import and export retinal layer thickness data to an SQL database, thereby allowing for the collation of data from a number of collaborating sites.

A direct morphometric comparison of five labeling protocols for multi-atlas driven automatic segmentation of the hippocampus in Alzheimer's disease.

PubMed

Nestor, Sean M; Gibson, Erin; Gao, Fu-Qiang; Kiss, Alex; Black, Sandra E

2013-02-01

Hippocampal volumetry derived from structural MRI is increasingly used to delineate regions of interest for functional measurements, assess efficacy in therapeutic trials of Alzheimer's disease (AD) and has been endorsed by the new AD diagnostic guidelines as a radiological marker of disease progression. Unfortunately, morphological heterogeneity in AD can prevent accurate demarcation of the hippocampus. Recent developments in automated volumetry commonly use multi-template fusion driven by expert manual labels, enabling highly accurate and reproducible segmentation in disease and healthy subjects. However, there are several protocols to define the hippocampus anatomically in vivo, and the method used to generate atlases may impact automatic accuracy and sensitivity - particularly in pathologically heterogeneous samples. Here we report a fully automated segmentation technique that provides a robust platform to directly evaluate both technical and biomarker performance in AD among anatomically unique labeling protocols. For the first time we test head-to-head the performance of five common hippocampal labeling protocols for multi-atlas based segmentation, using both the Sunnybrook Longitudinal Dementia Study and the entire Alzheimer's Disease Neuroimaging Initiative 1 (ADNI-1) baseline and 24-month dataset. We based these atlas libraries on the protocols of (Haller et al., 1997; Killiany et al., 1993; Malykhin et al., 2007; Pantel et al., 2000; Pruessner et al., 2000), and a single operator performed all manual tracings to generate de facto "ground truth" labels. All methods distinguished between normal elders, mild cognitive impairment (MCI), and AD in the expected directions, and showed comparable correlations with measures of episodic memory performance. Only more inclusive protocols distinguished between stable MCI and MCI-to-AD converters, and had slightly better associations with episodic memory. Moreover, we demonstrate that protocols including more posterior anatomy and dorsal white matter compartments furnish the best voxel-overlap accuracies (Dice Similarity Coefficient=0.87-0.89), compared to expert manual tracings, and achieve the smallest sample sizes required to power clinical trials in MCI and AD. The greatest distribution of errors was localized to the caudal hippocampus and the alveus-fimbria compartment when these regions were excluded. The definition of the medial body did not significantly alter accuracy among more comprehensive protocols. Voxel-overlap accuracies between automatic and manual labels were lower for the more pathologically heterogeneous Sunnybrook study in comparison to the ADNI-1 sample. Finally, accuracy among protocols appears to significantly differ the most in AD subjects compared to MCI and normal elders. Together, these results suggest that selection of a candidate protocol for fully automatic multi-template based segmentation in AD can influence both segmentation accuracy when compared to expert manual labels and performance as a biomarker in MCI and AD. Copyright © 2012 Elsevier Inc. All rights reserved.

A Direct Morphometric Comparison of Five Labeling Protocols for Multi-Atlas Driven Automatic Segmentation of the Hippocampus in Alzheimer’s Disease

PubMed Central

Nestor, Sean M.; Gibson, Erin; Gao, Fu-Qiang; Kiss, Alex; Black, Sandra E.

2012-01-01

Hippocampal volumetry derived from structural MRI is increasingly used to delineate regions of interest for functional measurements, assess efficacy in therapeutic trials of Alzheimer’s disease (AD) and has been endorsed by the new AD diagnostic guidelines as a radiological marker of disease progression. Unfortunately, morphological heterogeneity in AD can prevent accurate demarcation of the hippocampus. Recent developments in automated volumetry commonly use multitemplate fusion driven by expert manual labels, enabling highly accurate and reproducible segmentation in disease and healthy subjects. However, there are several protocols to define the hippocampus anatomically in vivo, and the method used to generate atlases may impact automatic accuracy and sensitivity – particularly in pathologically heterogeneous samples. Here we report a fully automated segmentation technique that provides a robust platform to directly evaluate both technical and biomarker performance in AD among anatomically unique labeling protocols. For the first time we test head-to-head the performance of five common hippocampal labeling protocols for multi-atlas based segmentation, using both the Sunnybrook Longitudinal Dementia Study and the entire Alzheimer’s Disease Neuroimaging Initiative 1 (ADNI-1) baseline and 24-month dataset. We based these atlas libraries on the protocols of (Haller et al., 1997; Killiany et al., 1993; Malykhin et al., 2007; Pantel et al., 2000; Pruessner et al., 2000), and a single operator performed all manual tracings to generate de facto “ground truth” labels. All methods distinguished between normal elders, mild cognitive impairment (MCI), and AD in the expected directions, and showed comparable correlations with measures of episodic memory performance. Only more inclusive protocols distinguished between stable MCI and MCI-to-AD converters, and had slightly better associations with episodic memory. Moreover, we demonstrate that protocols including more posterior anatomy and dorsal white matter compartments furnish the best voxel-overlap accuracies (Dice Similarity Coefficient = 0.87–0.89), compared to expert manual tracings, and achieve the smallest sample sizes required to power clinical trials in MCI and AD. The greatest distribution of errors was localized to the caudal hippocampus and alveus-fimbria compartment when these regions were excluded. The definition of the medial body did not significantly alter accuracy among more comprehensive protocols. Voxel-overlap accuracies between automatic and manual labels were lower for the more pathologically heterogeneous Sunnybrook study in comparison to the ADNI-1 sample. Finally, accuracy among protocols appears to significantly differ the most in AD subjects compared to MCI and normal elders. Together, these results suggest that selection of a candidate protocol for fully automatic multi-template based segmentation in AD can influence both segmentation accuracy when compared to expert manual labels and performance as a biomarker in MCI and AD. PMID:23142652

The PiGeOn project: protocol for a longitudinal study examining psychosocial, behavioural and ethical issues and outcomes in cancer tumour genomic profiling.

PubMed

Best, Megan; Newson, Ainsley J; Meiser, Bettina; Juraskova, Ilona; Goldstein, David; Tucker, Kathy; Ballinger, Mandy L; Hess, Dominique; Schlub, Timothy E; Biesecker, Barbara; Vines, Richard; Vines, Kate; Thomas, David; Young, Mary-Anne; Savard, Jacqueline; Jacobs, Chris; Butow, Phyllis

2018-04-05

Genomic sequencing in cancer (both tumour and germline), and development of therapies targeted to tumour genetic status, hold great promise for improvement of patient outcomes. However, the imminent introduction of genomics into clinical practice calls for better understanding of how patients value, experience, and cope with this novel technology and its often complex results. Here we describe a protocol for a novel mixed-methods, prospective study (PiGeOn) that aims to examine patients' psychosocial, cognitive, affective and behavioural responses to tumour genomic profiling and to integrate a parallel critical ethical analysis of returning results. This is a cohort sub-study of a parent tumour genomic profiling programme enrolling patients with advanced cancer. One thousand patients will be recruited for the parent study in Sydney, Australia from 2016 to 2019. They will be asked to complete surveys at baseline, three, and five months. Primary outcomes are: knowledge, preferences, attitudes and values. A purposively sampled subset of patients will be asked to participate in three semi-structured interviews (at each time point) to provide deeper data interpretation. Relevant ethical themes will be critically analysed to iteratively develop or refine normative ethical concepts or frameworks currently used in the return of genetic information. This will be the first Australian study to collect longitudinal data on cancer patients' experience of tumour genomic profiling. Findings will be used to inform ongoing ethical debates on issues such as how to effectively obtain informed consent for genomic profiling return results, distinguish between research and clinical practice and manage patient expectations. The combination of quantitative and qualitative methods will provide comprehensive and critical data on how patients cope with 'actionable' and 'non-actionable' results. This information is needed to ensure that when tumour genomic profiling becomes part of routine clinical care, ethical considerations are embedded, and patients are adequately prepared and supported during and after receiving results. Not required for this sub-study, parent trial registration ACTRN12616000908437 .

A Novel In Vivo Protocol for Molecular Study of Radiation-Induced Fibrosis in Head and Neck Cancer Patients.

PubMed

Krisciunas, Gintas P; Platt, Michael; Trojanowska, Maria; Grillone, Gregory A; Haines, Paul C; Langmore, Susan E

2016-03-01

Radiation-induced fibrosis is a common complication for patients following head and neck cancer treatment. This study presents a novel minimally invasive protocol for molecular study of fibrosis in the stromal tissues. Subjects with radiation-induced fibrosis in the head and neck who were at least 6 months post treatment received submental core needle biopsies, followed by molecular processing and quantification of gene expression for 14 select pro-inflammatory and pro-fibrotic genes. Control biopsies from the upper arm were obtained from the same subjects. Patients were followed up at 1 and 2 weeks to monitor for safety and adverse outcomes. Six subjects were enrolled and completed the study. No subjects experienced adverse outcomes or complication. An 18 gauge core biopsy needle with a 10 mm notch inserted for up to 60 seconds was needed. Subcutaneous tissue yielded 3 ng of RNA, amplified to 6 µg of cDNA, allowing for adequately sensitive quantitative polymerase chain reaction (qPCR) analysis of approximately 28 genes. This study demonstrates the safety and utility of a novel technique for the molecular study of fibrosis in head and neck cancer patients. Longitudinal studies of patients undergoing radiation therapy will allow for identification of molecular targets that contribute to the process of fibrosis in the head and neck. © The Author(s) 2015.

Anonymization of Longitudinal Electronic Medical Records

PubMed Central

Tamersoy, Acar; Loukides, Grigorios; Nergiz, Mehmet Ercan; Saygin, Yucel; Malin, Bradley

2013-01-01

Electronic medical record (EMR) systems have enabled healthcare providers to collect detailed patient information from the primary care domain. At the same time, longitudinal data from EMRs are increasingly combined with biorepositories to generate personalized clinical decision support protocols. Emerging policies encourage investigators to disseminate such data in a deidentified form for reuse and collaboration, but organizations are hesitant to do so because they fear such actions will jeopardize patient privacy. In particular, there are concerns that residual demographic and clinical features could be exploited for reidentification purposes. Various approaches have been developed to anonymize clinical data, but they neglect temporal information and are, thus, insufficient for emerging biomedical research paradigms. This paper proposes a novel approach to share patient-specific longitudinal data that offers robust privacy guarantees, while preserving data utility for many biomedical investigations. Our approach aggregates temporal and diagnostic information using heuristics inspired from sequence alignment and clustering methods. We demonstrate that the proposed approach can generate anonymized data that permit effective biomedical analysis using several patient cohorts derived from the EMR system of the Vanderbilt University Medical Center. PMID:22287248

The Andalusian Bipolar Family (ABiF) Study: Protocol and sample description.

PubMed

Guzman-Parra, Jose; Rivas, Fabio; Strohmaier, Jana; Forstner, Andreas; Streit, Fabian; Auburger, Georg; Propping, Peter; Orozco-Diaz, Guillermo; González, Maria José; Gil-Flores, Susana; Cabaleiro-Fabeiro, Francisco Javier; Del Río-Noriega, Francisco; Perez-Perez, Fermin; Haro-González, Jesus; de Diego-Otero, Yolanda; Romero-Sanchiz, Pablo; Moreno-Küstner, Berta; Cichon, Sven; Nöthen, Markus M; Rietschel, Marcella; Mayoral, Fermin

2017-06-12

Here, we present the first description of the Andalusian Bipolar Family (ABiF) Study. This longitudinal investigation of families from Andalusia, Spain commenced in 1997 with the aim of elucidating the molecular genetic causes of bipolar affective disorder. The cohort has since contributed to a number of key genetic findings, as reported in international journals. However, insight into the genetic underpinnings of the disorder in these families remains limited. In the initial 1997-2003 study phase, 100 multiplex bipolar disorder and other mood disorder families were recruited. The ongoing second phase of the project commenced in 2013, and involves follow-up of a subgroup of the originally recruited families. The aim of the follow-up investigation is to generate: i) longitudinal clinical data; ii) results from detailed neuropsychological assessments; and iii) a more extensive collection of biomaterials for future molecular biological studies. The ABiF Study will thus generate a valuable resource for future investigations into the aetiology of bipolar affective disorder; in particular the causes of high disease loading within multiply affected families. We discuss the value of this approach in terms of new technologies for the identification of high-penetrance genetic factors. These new technologies include exome and whole genome sequencing, and the use of induced pluripotent stem cells or model organisms to determine functional consequences. Copyright © 2017 SEP y SEPB. Publicado por Elsevier España, S.L.U. All rights reserved.

Data resource profile: the World Health Organization Study on global AGEing and adult health (SAGE).

PubMed

Kowal, Paul; Chatterji, Somnath; Naidoo, Nirmala; Biritwum, Richard; Fan, Wu; Lopez Ridaura, Ruy; Maximova, Tamara; Arokiasamy, Perianayagam; Phaswana-Mafuya, Nancy; Williams, Sharon; Snodgrass, J Josh; Minicuci, Nadia; D'Este, Catherine; Peltzer, Karl; Boerma, J Ties

2012-12-01

Population ageing is rapidly becoming a global issue and will have a major impact on health policies and programmes. The World Health Organization's Study on global AGEing and adult health (SAGE) aims to address the gap in reliable data and scientific knowledge on ageing and health in low- and middle-income countries. SAGE is a longitudinal study with nationally representative samples of persons aged 50+ years in China, Ghana, India, Mexico, Russia and South Africa, with a smaller sample of adults aged 18-49 years in each country for comparisons. Instruments are compatible with other large high-income country longitudinal ageing studies. Wave 1 was conducted during 2007-2010 and included a total of 34 124 respondents aged 50+ and 8340 aged 18-49. In four countries, a subsample consisting of 8160 respondents participated in Wave 1 and the 2002/04 World Health Survey (referred to as SAGE Wave 0). Wave 2 data collection will start in 2012/13, following up all Wave 1 respondents. Wave 3 is planned for 2014/15. SAGE is committed to the public release of study instruments, protocols and meta- and micro-data: access is provided upon completion of a Users Agreement available through WHO's SAGE website (www.who.int/healthinfo/systems/sage) and WHO's archive using the National Data Archive application (http://apps.who.int/healthinfo/systems/surveydata).

Data Resource Profile: The World Health Organization Study on global AGEing and adult health (SAGE)

PubMed Central

Kowal, Paul; Chatterji, Somnath; Naidoo, Nirmala; Biritwum, Richard; Fan, Wu; Lopez Ridaura, Ruy; Maximova, Tamara; Arokiasamy, Perianayagam; Phaswana-Mafuya, Nancy; Williams, Sharon; Snodgrass, J Josh; Minicuci, Nadia; D'Este, Catherine; Peltzer, Karl; Boerma, J Ties; Yawson, A.; Mensah, G.; Yong, J.; Guo, Y.; Zheng, Y.; Parasuraman, P.; Lhungdim, H.; Sekher, TV.; Rosa, R.; Belov, VB.; Lushkina, NP; Peltzer, K.; Makiwane, M.; Zuma, K.; Ramlagan, S.; Davids, A.; Mbelle, N.; Matseke, G.; Schneider, M.; Tabane, C.; Tollman, S.; Kahn, K.; Ng, N.; Juvekar, S.; Sankoh, O.; Debpuur, CY.; Nguyen, TK Chuc; Gomez-Olive, FX.; Hakimi, M.; Hirve, S.; Abdullah, S.; Hodgson, A.; Kyobutungi, C.; Egondi, T.; Mayombana, C.; Minh, HV.; Mwanyangala, MA.; Razzaque, A.; Wilopo, S.; Streatfield, PK.; Byass, P.; Wall, S.; Scholten, F.; Mugisha, J.; Seeley, J.; Kinyanda, E.; Nyirenda, M.; Mutevedzi, P.; Newell, M-L.

2012-01-01

Population ageing is rapidly becoming a global issue and will have a major impact on health policies and programmes. The World Health Organization’s Study on global AGEing and adult health (SAGE) aims to address the gap in reliable data and scientific knowledge on ageing and health in low- and middle-income countries. SAGE is a longitudinal study with nationally representative samples of persons aged 50+ years in China, Ghana, India, Mexico, Russia and South Africa, with a smaller sample of adults aged 18–49 years in each country for comparisons. Instruments are compatible with other large high-income country longitudinal ageing studies. Wave 1 was conducted during 2007–2010 and included a total of 34 124 respondents aged 50+ and 8340 aged 18–49. In four countries, a subsample consisting of 8160 respondents participated in Wave 1 and the 2002/04 World Health Survey (referred to as SAGE Wave 0). Wave 2 data collection will start in 2012/13, following up all Wave 1 respondents. Wave 3 is planned for 2014/15. SAGE is committed to the public release of study instruments, protocols and meta- and micro-data: access is provided upon completion of a Users Agreement available through WHO’s SAGE website (www.who.int/healthinfo/systems/sage) and WHO’s archive using the National Data Archive application (http://apps.who.int/healthinfo/systems/surveydata). PMID:23283715

Implementation of Injury and Illness Surveillance Protocols in Varsity Athletes.

PubMed

Gamble, Alexander Shand Davis; Mountjoy, Margo Lynn; Bigg, Jessica Lynne; Spriet, Lawrence Leon

2018-05-02

To develop and implement a prospective varsity athlete surveillance system to identify injury and illness trends in a multisport varsity-level university setting. Longitudinal prospective surveillance study. Varsity-level sport program at the University of Guelph, Guelph, ON, Canada. Athletic therapists (ATs) (n = 35) from 17 varsity sports provided injury and illness information on 624 varsity-level athletes (381 men and 243 women) during the 2016/2017 competitive season. Team ATs reported athlete health complaints weekly. Athletes reported additional details on the injury or illness that was reported. The outcome measurements included when the injury or illness occurred, anatomical location, diagnosis, cause, perceived severity, treatment, estimated athlete exposure (AE) to training and competition, and time loss from sport. Measures were recorded from the teams' first competition through to end their season and/or playoffs. Twenty-nine of 30 varsity sports teams participated in this injury and illness surveillance protocol. The compliance of team ATs and varsity athletes was 89% (men: 94%, women: 82%). The overall injury and illness rates were 5.5 injuries and 1.7 illnesses per 1000 AEs, respectively. Men's injury rates were greater than women's, and injury rates of contact sports were greater than noncontact sports. The utilization of a prospective injury and illness surveillance protocol in the Canadian University sport system is feasible with good athlete, AT, and coach acceptance. The surveillance data should inform future injury and illness prevention strategies.

Longitudinal Research on Aging Drivers (LongROAD): study design and methods.

PubMed

Li, Guohua; Eby, David W; Santos, Robert; Mielenz, Thelma J; Molnar, Lisa J; Strogatz, David; Betz, Marian E; DiGuiseppi, Carolyn; Ryan, Lindsay H; Jones, Vanya; Pitts, Samantha I; Hill, Linda L; DiMaggio, Charles J; LeBlanc, David; Andrews, Howard F

2017-12-01

As an important indicator of mobility, driving confers a host of social and health benefits to older adults. Despite the importance of safe mobility as the population ages, longitudinal data are lacking about the natural history and determinants of driving safety in older adults. The Longitudinal Research on Aging Drivers (LongROAD) project is a multisite prospective cohort study designed to generate empirical data for understanding the role of medical, behavioral, environmental and technological factors in driving safety during the process of aging. A total of 2990 active drivers aged 65-79 years at baseline have been recruited through primary care clinics or health care systems in five study sites located in California, Colorado, Maryland, Michigan, and New York. Consented participants were assessed at baseline with standardized research protocols and instruments, including vehicle inspection, functional performance tests, and "brown-bag review" of medications. The primary vehicle of each participant was instrumented with a small data collection device that records detailed driving data whenever the vehicle is operating and detects when a participant is driving. Annual follow-up is being conducted for up to three years with a telephone questionnaire at 12 and 36 months and in-person assessment at 24 months. Medical records are reviewed annually to collect information on clinical diagnoses and healthcare utilization. Driving records, including crashes and violations, are collected annually from state motor vehicle departments. Pilot testing was conducted on 56 volunteers during March-May 2015. Recruitment and enrollment were completed between July 2015 and March 2017. Results of the LongROAD project will generate much-needed evidence for formulating public policy and developing intervention programs to maintain safe mobility while ensuring well-being for older adults.

A patient self-collection method for longitudinal monitoring of respiratory virus infection in solid organ transplant recipients.

PubMed

Preiksaitis, Carl M; Kuypers, Jane M; Fisher, Cynthia E; Campbell, Angela P; Jerome, Keith R; Huang, Meei-Li; Boeckh, Michael; Limaye, Ajit P

2015-01-01

Methods for the longitudinal study of respiratory virus infections are cumbersome and limit our understanding of the natural history of these infections in solid organ transplant (SOT) recipients. To assess the feasibility and patient acceptability of self-collected foam nasal swabs for detection of respiratory viruses in SOT recipients and to define the virologic and clinical course. We prospectively monitored the course of symptomatic respiratory virus infection in 18 SOT patients (14 lung, 3 liver, and 1 kidney) using patient self-collected swabs. The initial study sample was positive in 15 patients with the following respiratory viruses: rhinovirus (6), metapneumovirus (1), coronavirus (2), respiratory syncytial virus (2), parainfluenza virus (2), and influenza A virus (2). One hundred four weekly self-collected nasal swabs were obtained, with a median of 4 samples per patient (range 1-17). Median duration of viral detection was 21 days (range 4-77 days). Additional new respiratory viruses detected during follow-up of these 15 patients included rhinovirus (3), metapneumovirus (2), coronavirus (1), respiratory syncytial virus (1), parainfluenza virus (1), and adenovirus (1). Specimen collection compliance was good; 16/18 (89%) patients collected all required specimens and 79/86 (92%) follow-up specimens were obtained within the 7 ± 3 day protocol-defined window. All participants agreed or strongly agreed that the procedure was comfortable, simple, and 13/14 (93%) were willing to participate in future studies using this procedure. Self-collected nasal swabs provide a convenient, feasible, and patient-acceptable methodology for longitudinal monitoring of upper respiratory virus infection in SOT recipients. Copyright © 2014 Elsevier B.V. All rights reserved.

Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol.

PubMed

Rimland, Joseph M; Abraha, Iosief; Luchetta, Maria Laura; Cozzolino, Francesco; Orso, Massimiliano; Cherubini, Antonio; Dell'Aquila, Giuseppina; Chiatti, Carlos; Ambrosio, Giuseppe; Montedori, Alessandro

2016-06-01

Healthcare databases are useful sources to investigate the epidemiology of chronic obstructive pulmonary disease (COPD), to assess longitudinal outcomes in patients with COPD, and to develop disease management strategies. However, in order to constitute a reliable source for research, healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of codes related to COPD diagnoses in healthcare databases. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched using appropriate search strategies. Studies that evaluated the validity of COPD codes (such as the International Classification of Diseases 9th Revision and 10th Revision system; the Real codes system or the International Classification of Primary Care) in healthcare databases will be included. Inclusion criteria will be: (1) the presence of a reference standard case definition for COPD; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc); and (3) the use of a healthcare database (including administrative claims databases, electronic healthcare databases or COPD registries) as a data source. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on the Standards for Reporting of Diagnostic accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 statement. Ethics approval is not required. Results of this study will be submitted to a peer-reviewed journal for publication. The results from this systematic review will be used for outcome research on COPD and will serve as a guide to identify appropriate case definitions of COPD, and reference standards, for researchers involved in validating healthcare databases. CRD42015029204. 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/

How socioeconomic inequalities impact pathways of care for coronary artery disease among elderly patients: study protocol for a qualitative longitudinal study

PubMed Central

Schröder, Sara L; Fink, Astrid; Schumann, Nadine; Moor, Irene; Plehn, Alexander; Richter, Matthias

2015-01-01

Introduction Several studies have identified that socioeconomic inequalities in coronary artery disease (CAD) morbidity and mortality lead to a disadvantage in patients with low socioeconomic status (SES). International studies have shown that socioeconomic inequalities also exist in terms of access, utilisation and quality of cardiac care. The aim of this qualitative study is to provide information on the impact of socioeconomic inequalities on the pathway of care for CAD, and to establish which factors lead to socioeconomic inequality of care to form and expand existing scientific theories. Methods and analysis A longitudinal qualitative study with 48 patients with CAD, aged 60–80 years, is being conducted. Patients have been recruited consecutively at the University Hospital in Halle/Saale, Germany, and will be followed for a period of 6 months. Patients are interviewed two times face-to-face using semistructured interviews. Data are transcribed and analysed based on grounded theory. Ethics and dissemination Only participants who have been informed and who have signed a declaration of consent have been included in the study. The study complies rigorously with data protection legislation. Approval of the Ethical Review Committee at the Martin-Luther University Halle-Wittenberg, Germany was obtained. The results of the study will be presented at several congresses, and will be published in high-quality peer-reviewed international journals. Trial registration number This study has been registered with the German Clinical Trials Register and assigned DRKS00007839. PMID:26553827

Protocol of a longitudinal cohort study on physical activity behaviour in physically disabled patients participating in a rehabilitation counselling programme: ReSpAct.

PubMed

Alingh, Rolinde A; Hoekstra, Femke; van der Schans, Cees P; Hettinga, Florentina J; Dekker, Rienk; van der Woude, Lucas H V

2015-01-29

Stimulating physical activity behaviour in persons with a physical disability is important, especially after discharge from rehabilitation. A tailored counselling programme covering both the period of the rehabilitation treatment and the first months at home seems on the average effective. However, a considerable variation in response is observed in the sense that some patients show a relevant beneficial response while others show no or only a small response on physical activity behaviour. The Rehabilitation, Sports and Active lifestyle (ReSpAct) study aims to estimate the associations of patient and programme characteristics with patients' physical activity behaviour after their participation in a tailored counselling programme. A questionnaire-based nationwide longitudinal prospective cohort study is conducted. Participants are recruited from 18 rehabilitation centres and hospitals in The Netherlands. 2000 participants with a physical disability or chronic disease will be followed during and after their participation in a tailored counselling programme. Programme outcomes on physical activity behaviour and patient as well as programme characteristics that may be associated with differences in physical activity behaviour after programme completion are being assessed. Data collection takes place at baseline and 14, 33 and 52 weeks after discharge from rehabilitation. The study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Groningen and at individual participating institutions. All participants give written informed consent. The study results will provide new insights into factors that may help explain the differences in physical activity behaviour of patients with a physical disability after they have participated in the same physical activity and sports stimulation programme. Thereby, it will support healthcare professionals to tailor their guidance and care to individual patients in order to stimulate physical activity after discharge in a more efficient and effective way. NTR3961. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee.

PubMed

von Elm, Erik; Röllin, Alexandra; Blümle, Anette; Huwiler, Karin; Witschi, Mark; Egger, Matthias

2008-04-05

Not all clinical trials are published, which may distort the evidence that is available in the literature. We studied the publication rate of a cohort of clinical trials and identified factors associated with publication and nonpublication of results. We analysed the protocols of randomized clinical trials of drug interventions submitted to the research ethics committee of University Hospital (Inselspital) Bern, Switzerland from 1988 to 1998. We identified full articles published up to 2006 by searching the Cochrane CENTRAL database (issue 02/2006) and by contacting investigators. We analyzed factors associated with the publication of trials using descriptive statistics and logistic regression models. 451 study protocols and 375 corresponding articles were analyzed. 233 protocols resulted in at least one publication, a publication rate of 52%. A total of 366 (81%) trials were commercially funded, 47 (10%) had non-commercial funding. 346 trials (77%) were multi-centre studies and 272 of these (79%) were international collaborations. In the adjusted logistic regression model non-commercial funding (Odds Ratio [OR] 2.42, 95% CI 1.14-5.17), multi-centre status (OR 2.09, 95% CI 1.03-4.24), international collaboration (OR 1.87, 95% CI 0.99-3.55) and a sample size above the median of 236 participants (OR 2.04, 95% CI 1.23-3.39) were associated with full publication. In this cohort of applications to an ethics committee in Switzerland, only about half of clinical drug trials were published. Large multi-centre trials with non-commercial funding were more likely to be published than other trials, but most trials were funded by industry.

The effect of standardized patient feedback in teaching surgical residents informed consent: results of a pilot study.

PubMed

Leeper-Majors, Kristine; Veale, James R; Westbrook, Thomas S; Reed, Kendall

2003-01-01

The purpose of this pilot study was to determine the effectiveness of using feedback from a standardized patient (SP) to teach a surgical resident (SR) informed consent (IC) protocol. Four general case types of increasing difficulty were tested in a longitudinal experimental design format. The four types of cases were appendectomy, cholecystectomy, colorectal cancer, and breast cancer. Eight SRs of varying years of completion in medical school served as subjects-four in the experimental group (received performance feedback from an SP) and four in the control group (received no SP feedback). Both the control and experimental groups participated in two patient encounters per case type. The first patient encounter served as the pretest, and the second patient encounter was the posttest. In each encounter, an SP rated the resident on 14 measures using an open-ended seven-point rating scale adopted and modified from the Brown University Interpersonal Skill Evaluation (BUISE). Each resident also reviewed a videotape of an expert giving IC between pretest and the posttest for basic instructional protocol. Random stratified sampling was used to equally distribute the residents by postgraduate years. A total of 16 SPs were used in this study. All patient/SR encounters were videotaped. There was a statistically significant overall change--pretest to posttest and across cases (p = 0.001). The group effect was statistically significant (p = 0.000), with the experimental group averaging about 10 points greater than the control group. Standardized patient feedback is an effective modality in teaching surgical residents informed consent protocol. This conclusion is tentative, due to the limitations of sample size. The results of this study support continued research on the effects of standardized patient feedback to teach informed consent to surgical residents.

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study.

PubMed

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol implementation to date. We expect that these novel measures will be feasible and acceptable. The implications of this research will be the identification and evaluation of innovative and accurate metrics of ARV adherence for future implementation.

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study

PubMed Central

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

Background There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. Methods The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Discussion Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol implementation to date. We expect that these novel measures will be feasible and acceptable. The implications of this research will be the identification and evaluation of innovative and accurate metrics of ARV adherence for future implementation. PMID:29950816

Learning ability in aged beagle dogs is preserved by behavioral enrichment and dietary fortification: a two-year longitudinal study.

PubMed

Milgram, N W; Head, E; Zicker, S C; Ikeda-Douglas, C J; Murphey, H; Muggenburg, B; Siwak, C; Tapp, D; Cotman, C W

2005-01-01

The effectiveness of two interventions, dietary fortification with antioxidants and a program of behavioral enrichment, was assessed in a longitudinal study of cognitive aging in beagle dogs. A baseline protocol of cognitive testing was used to select four cognitively equivalent groups: control food-control experience (C-C), control food-enriched experience (C-E), antioxidant fortified food-control experience (A-C), and antioxidant fortified food-enriched experience(A-E). We also included two groups of young behaviorally enriched dogs, one receiving the control food and the other the fortified food. Discrimination learning and reversal was assessed after one year of treatment with a size discrimination task, and again after two years with a black/white discrimination task. The four aged groups were comparable at baseline. At one and two years, the aged combined treatment group showed more accurate learning than the other aged groups. Discrimination learning was significantly improved by behavioral enrichment. Reversal learning was improved by both behavioral enrichment and dietary fortification. By contrast, the fortified food had no effect on the young dogs. These results suggest that behavioral enrichment or dietary fortification with antioxidants over a long-duration can slow age-dependent cognitive decline, and that the two treatments together are more effective than either alone in older dogs.

Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial.

PubMed

Quinlan, Alison; Rhodes, Ryan E; Beauchamp, Mark R; Symons Downs, Danielle; Warburton, Darren E R; Blanchard, Chris M

2017-11-09

Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners. This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 .

ARAMIS (The American Rheumatism Association Medical Information System)

PubMed Central

Fries, James F.; McShane, Dennis J.

1986-01-01

ARAMIS is a prototype of a national chronic-disease data-bank system consisting of parallel, longitudinal, clinical data sets from 17 diverse locations; the data describe the courses of thousands of patients with rheumatic disease followed over many years. Chronic-disease data-bank systems include the data themselves, protocols to ensure their quality, computer systems for their manipulation, statistical procedures for analysis and an appropriately skilled staff. Such a data resource facilitates analyzing long-term health outcomes and the factors associated with particular outcomes. Such systems are mandated by the overwhelming prevalence of chronic illness; the variability, complexity and uniqueness of a patient's course; the difficulties of traditional randomized approaches in these areas, and the time span required for studying these problems. ImagesFigure 4. PMID:3492816

Physiological Responses to On-Court vs Running Interval Training in Competitive Tennis Players

PubMed Central

Fernandez-Fernandez, Jaime; Sanz-Rivas, David; Sanchez-Muñoz, Cristobal; de la Aleja Tellez, Jose Gonzalez; Buchheit, Martin; Mendez-Villanueva, Alberto

2011-01-01

The aim of this study was to compare heart rate (HR), blood lactate (LA) and rate of perceived exertion (RPE) responses to a tennis-specific interval training (i.e., on-court) session with that of a matched-on-time running interval training (i.e., off-court). Eight well-trained, male (n = 4) and female (n = 4) tennis players (mean ± SD; age: 16.4 ± 1.8 years) underwent an incremental test where peak treadmill speed, maximum HR (HRmax) and maximum oxygen uptake (VO2max) were determined. The two interval training protocols (i.e., off- court and on-court) consisted of 4 sets of 120 s of work, interspersed with 90 s rest. Percentage of HRmax (95.9 ± 2.4 vs. 96.1 ± 2.2%; p = 0.79), LA (6.9 ± 2.5 vs. 6.2 ± 2.4 mmol·L-1; p = 0.14) and RPE (16.7 ± 2.1 vs. 16.3 ± 1.8; p = 0.50) responses were similar for off-court and on-court, respectively. The two interval training protocols used in the present study have equivalent physiological responses. Longitudinal studies are still warranted but tennis-specific interval training sessions could represent a time-efficient alternative to off-court (running) interval training for the optimization of the specific cardiorespiratory fitness in tennis players. Key points On-court interval training protocol can be used as an alternative to running interval training Technical/tactical training should be performed under conditions that replicate the physical and technical demands of a competitive match During the competitive season tennis on-court training might be preferred to off-court training PMID:24150630

Fixed-flexion knee radiography using a new positioning device produced highly repeatable measurements of joint space width: ELSA-Brasil Musculoskeletal Study (ELSA-Brasil MSK).

PubMed

Telles, Rosa Weiss; Costa-Silva, Luciana; Machado, Luciana A C; Reis, Rodrigo Citton Padilha Dos; Barreto, Sandhi Maria

To describe the performance of a non-fluoroscopic fixed-flexion PA radiographic protocol with a new positioning device, developed for the assessment of knee osteoarthritis (OA) in Brazilian Longitudinal Study of Adult Health Musculoskeletal Study (ELSA-Brasil MSK). A test-retest design including 19 adults (38 knee images) was conducted. Feasibility of the radiographic protocol was assessed by image quality parameters and presence of radioanatomic alignment according to intermargin distance (IMD) values. Repeatability was assessed for IMD and joint space width (JSW) measured at three different locations. Approximately 90% of knee images presented excellent quality. Frequencies of nearly perfect radioanatomic alignment (IMD ≤1mm) ranged from 29% to 50%, and satisfactory alignment was found in up to 71% and 76% of the images (IMD ≤1.5mm and ≤1.7mm, respectively). Repeatability analyses yielded the following results: IMD [SD of mean difference=1.08; coefficient of variation (%CV)=54.68%; intraclass correlation coefficient (ICC) (95%CI)=0.59 (0.34-0.77)]; JSW [SD of mean difference=0.34-0.61; %CV=4.48%-9.80%; ICC (95%CI)=0.74 (0.55-0.85)-0.94 (0.87-0.97)]. Adequately reproducible measurements of IMD and JSW were found in 68% and 87% of the images, respectively. Despite the difficulty in achieving consistent radioanatomic alignment between subsequent radiographs in terms of IMD, the protocol produced highly repeatable JSW measurements when these were taken at midpoint and 10mm from the medial extremity of the medial tibial plateau. Therefore, measurements of JSW at these locations can be considered adequate for the assessment of knee OA in ELSA-Brasil MSK. Copyright © 2016. Published by Elsevier Editora Ltda.

Effectiveness of various irrigation protocols for the removal of calcium hydroxide from artificial standardized grooves

PubMed Central

GOKTURK, Hakan; OZKOCAK, Ismail; BUYUKGEBIZ, Feyzi; DEMIR, Osman

2017-01-01

Abstract Objective The aim of this study was to investigate the ability of laser-activated irrigation (LAI), XP-endo Finisher, CanalBrush, Vibringe, passive ultrasonic irrigation (PUI), and conventional syringe irrigation systems on the removal of calcium hydroxide (CH) from simulated root canal irregularities. Material and Methods The root canals of one hundred and five extracted single-rooted teeth were instrumented using Reciproc rotary files up to size R40. The teeth were split longitudinally. Two of the three standard grooves were created in the coronal and apical section of one segment, and another in the middle part of the second segment. The standardized grooves were filled with CH and the root halves were reassembled. After 14 days, the specimens were randomly divided into 7 experimental groups (n=15/group). CH was removed as follows: Group 1: beveled needle irrigation; Group 2: double side-vented needle irrigation; Group 3: CanalBrush; Group 4: XP-endo Finisher; Group 5: Vibringe; Group 6: PUI; Group 7: LAI. The amount of remaining CH in the grooves was scored under a stereomicroscope at 20× magnification. Statistical evaluation was performed using Kruskal–Wallis and Bonferroni-Correction Mann–Whitney U tests. Results Groups 1 and 2 were the least efficient in eliminating CH from the grooves. Groups 6 and 7 eliminated more CH than the other protocols; however, no significant differences were found between these two groups (P>.05). Conclusions Nevertheless, none of the investigated protocols were able to completely remove all CH from all three root regions. LAI and PUI showed less residual CH than the other protocols from artificial grooves. PMID:28678948

Hypersensitivity and desensitization to antineoplastic agents: outcomes of 189 procedures with a new short protocol and novel diagnostic tools assessment.

PubMed

Madrigal-Burgaleta, R; Berges-Gimeno, M P; Angel-Pereira, D; Ferreiro-Monteagudo, R; Guillen-Ponce, C; Pueyo, C; Gomez de Salazar, E; Alvarez-Cuesta, E

2013-07-01

Desensitization to antineoplastic agents is becoming a standard of care. Efforts to establish and improve these techniques are being made at many institutions. Our aims are to evaluate a new rapid desensitization protocol designed to be shorter (approximately 4 h) and safer (reducing hazardous drugs exposure risks) and to assess the oxaliplatin-specific immunoglobulin E (IgE) as a novel diagnostic tool. Prospective, observational, longitudinal study with patients who, for a 1-year period, suffered reactions to antineoplastic agents and were referred to the Desensitization Program at Ramon y Cajal University Hospital (RCUH). Patients were included or excluded as desensitization candidates after anamnesis, skin testing, risk assessment, and graded challenge. Specific IgE was determined in oxaliplatin-reactive patients. Candidate patients were desensitized using the new RCUH rapid desensitization protocol. Of 189 intravenous rapid desensitizations, 188 were successfully accomplished in the 23 patients who met inclusion criteria for desensitization (of 58 referred patients). No breakthrough reactions occurred in 94% of desensitizations, and most breakthrough reactions were mild. In 10 oxaliplatin-reactive patients, 38 desensitizations were successfully accomplished. Sensitivity for oxaliplatin-specific IgE was 38% (0.35UI/l cutoff point) and 54% (0.10UI/l cutoff point); specificity was 100% for both cutoff points. In the hands of a Desensitization Program, managed by drug desensitization experts, this new protocol has proven an effective therapeutic tool for hypersensitivity to several antineoplastic agents (oxaliplatin, carboplatin, paclitaxel, docetaxel, cyclophosphamide, and rituximab); moreover, it improves safety handling of hazardous drugs. We report the first large series of oxaliplatin desensitizations. Oxaliplatin-specific IgE determination could be helpful. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Imaging mechanical properties of hepatic tissue by magnetic resonance elastography

NASA Astrophysics Data System (ADS)

Yin, Meng; Rouviere, Olivier; Burgart, Lawrence J.; Fidler, Jeff L.; Manduca, Armando; Ehman, Richard L.

2006-03-01

PURPOSE: To assess the feasibility of a modified phase-contrast MRI technique (MR Elastography) for quantitatively assessing the mechanical properties of hepatic tissues by imaging propagating acoustic shear waves. MATERIALS AND METHODS: Both phantom and human studies were performed to develop and optimize a practical imaging protocol by visualizing and investigating the diffraction field of shear waves generated from pneumatic longitudinal drivers. The effects of interposed ribs in a transcostal approach were also investigated. A gradient echo MRE pulse sequence was adapted for shear wave imaging in the liver during suspended respiration, and then tested to measure hepatic shear stiffness in 13 healthy volunteers and 1 patient with chronic liver disease to determine the potential of non-invasively detecting liver fibrosis. RESULTS: Phantom studies demonstrate that longitudinal waves generated by the driver are mode-converted to shear waves in a distribution governed by diffraction principles. The transcostal approach was determined to be the most effective method for generating shear waves in human studies. Hepatic stiffness measurements in the 13 normal volunteers demonstrated a mean value of 2.0+/-0.2kPa. The shear stiffness measurement in the patient was much higher at 8.5kPa. CONCLUSION: MR Elastography of the liver shows promise as a method to non-invasively detect and characterize diffuse liver disease, potentially reducing the need for biopsy to diagnose hepatic fibrosis.

Neuropsychiatric and cardiometabolic comorbidities in patients with previously diagnosed Cushing's disease: a longitudinal observational study.

PubMed

Dimopoulou, C; Geraedts, V; Stalla, G K; Sievers, C

2015-03-27

Only few studies have systematically investigated neuropsychiatric aspects in patients with Cushing's disease (CD). Pain syndromes have been described in patients with pituitary adenomas, but so far no systematical investigation has been conducted in patients with CD. Additionally, CD has an association with cardiometabolic comorbidities which ultimately leads to increased morbidity and mortality. Long-term treatment of the hypercortisolic state cannot prevent the persistence of an unfavourable cardiometabolic risk profile. Finally, chronic hypercortisolism is known to impact the health-related quality of life (HRQoL). We aim to systematically investigate the neuropsychiatric and cardiometabolic comorbidities, as well as assess the HRQoL, in patients with previously diagnosed CD in a longitudinal fashion. In this longitudinal study, we will assess 20 patients with CD displaying biochemical control 24 months after recruitment in the initial cross-sectional study (n=80). This will be a mixed cohort including patients after surgical, after radiation therapy and/or under current medical treatment for CD. Primary outcomes include changes in mean urinary free cortisol and changes in specific pain patterns. Secondary/exploratory neuropsychiatric domains include depression, anxiety, personality, sleep, body image and quality of life. Secondary/exploratory cardiometabolic domains include anthropometric parameters, cardiometabolic risk biomarkers and insulin resistance. Additional domains will be investigated if warranted by clinical indication. Safety assessment under medical therapy will include liver enzymes, ECG abnormalities and hyperglycaemia. Risk of damage from study-conditioned measures is very small and considered ethically justified. Dual-energy X-ray absorptiometry may call for detailed fracture risk assessment. However, the radiation dose is very small and only administered on clinical indication; therefore, it is considered ethically justified. This protocol has been approved by the local medical ethics committee. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM.

PubMed

Bonnot, Olivier; Bonneau, Dominique; Doudard, Aude; Duverger, Philippe

2016-11-22

Longitudinal studies on the evolution of autism spectrum disorder (ASD) symptoms are limited and have primarily used repeated measurements performed several months apart. However, measurements of changes in everyday life should more closely reflect the 'real life' of the patient and his or her family. We propose to study the child's ASD symptoms and their effect on the quality of life, psychological status and anxiety of the child's parents over a 6-month period using SMARTAUTISM, a smartphone application. This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period. Data will be recorded longitudinally over multiple weeks under natural conditions. The factors affecting the quality of life and anxiety of parents of children with ASD and the children's functional symptoms will be examined, and the feasibility of using a smartphone application designed for parents of ASD patients will be assessed. Explore the evolution of a child's behaviour over 6 months and the (psychological and social) effects of these changes on the family. Assess the feasibility of our application by examining the filling rate and application usage by parents for 6 months. 100 families containing 1 child diagnosed with ASD will be included. At baseline, sociodemographic, psychiatric and medical data will be recorded. The correlations of the general epidemiological variables (primary outcome measure) will be evaluated via multivariate analysis. The application filling rate (relative to the ideal filling rate) will be used to assess the feasibility of the application (secondary outcome measure). The SMARTAUTISM study has the approval of the local ethics committee, and data security will be ensured via the use of encryption and a secure medical server. The use of this application will be proposed at autism resource centres across France. 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/.

Rose Bengal Photothrombosis by Confocal Optical Imaging In Vivo: A Model of Single Vessel Stroke.

PubMed

Talley Watts, Lora; Zheng, Wei; Garling, R Justin; Frohlich, Victoria C; Lechleiter, James Donald

2015-06-23

In vivo imaging techniques have increased in utilization due to recent advances in imaging dyes and optical technologies, allowing for the ability to image cellular events in an intact animal. Additionally, the ability to induce physiological disease states such as stroke in vivo increases its utility. The technique described herein allows for physiological assessment of cellular responses within the CNS following a stroke and can be adapted for other pathological conditions being studied. The technique presented uses laser excitation of the photosensitive dye Rose Bengal in vivo to induce a focal ischemic event in a single blood vessel. The video protocol demonstrates the preparation of a thin-skulled cranial window over the somatosensory cortex in a mouse for the induction of a Rose Bengal photothrombotic event keeping injury to the underlying dura matter and brain at a minimum. Surgical preparation is initially performed under a dissecting microscope with a custom-made surgical/imaging platform, which is then transferred to a confocal microscope equipped with an inverted objective adaptor. Representative images acquired utilizing this protocol are presented as well as time-lapse sequences of stroke induction. This technique is powerful in that the same area can be imaged repeatedly on subsequent days facilitating longitudinal in vivo studies of pathological processes following stroke.

Use of virtual reality to promote hand therapy post-stroke

NASA Astrophysics Data System (ADS)

Tsoupikova, Daria; Stoykov, Nikolay; Vick, Randy; Li, Yu; Kamper, Derek; Listenberger, Molly

2013-03-01

A novel artistic virtual reality (VR) environment was developed and tested for use as a rehabilitation protocol for post-stroke hand rehabilitation therapy. The system was developed by an interdisciplinary team of engineers, art therapists, occupational therapists, and VR artists to improve patients' motivation and engagement. Specific exercises were developed to explicitly promote the practice of therapeutic tasks requiring hand and arm coordination for upper extremity rehabilitation. Here we describe system design, development, and user testing for efficiency, subject's satisfaction and clinical feasibility. We report results of the completed qualitative, pre-clinical pilot study of the system effectiveness for therapy. Fourteen stroke survivors with chronic hemiparesis participated in a single training session within the environment to gauge user response to the protocol through a custom survey. Results indicate that users found the system comfortable, enjoyable, tiring; instructions clear, and reported a high level of satisfaction with the VR environment and rehabilitation task variety and difficulty. Most patients reported very positive impressions of the VR environment and rated it highly, appreciating its engagement and motivation. We are currently conducting a longitudinal intervention study over 6 weeks in stroke survivors with chronic hemiparesis. Initial results following use of the system on the first subjects demonstrate that the system is operational and can facilitate therapy for post stroke patients with upper extremity impairment.

Prevalence and predictors of anxiety and depression after completion of chemotherapy for childhood acute lymphoblastic leukemia: A prospective longitudinal study

PubMed Central

Kunin-Batson, Alicia S.; Lu, Xiaomin; Balsamo, Lyn; Graber, Kelsey; Devidas, Meenakshi; Hunger, Stephen P.; Carroll, William L.; Winick, Naomi J.; Mattano, Leonard A.; Maloney, Kelly W.; Kadan-Lottick, Nina S.

2016-01-01

Background The months immediately following completion of treatment for childhood acute lymphoblastic leukemia (ALL) are often regarded as a stressful time for children and families. In this prospective, longitudinal study, the prevalence and predictors of anxiety and depressive symptoms after completion of treatment were examined. Methods Participants included 160 children (ages 2-9 years) with standard-risk ALL enrolled on Children's Oncology Group protocol AALL0331. Parents completed standardized rating scales of children's emotional-behavioral functioning, and measures of coping and family functioning at ∼1, 6, and 12 months after diagnosis, and again 3 months following completion of chemotherapy. Results Three months off-therapy, 24% of survivors had at-risk/clinically elevated anxiety scores and 28% had elevated depression scores, significantly higher than the expected 15% in the general population (p=0.028 and 0.001, respectively). Patients with elevated anxiety one-month post-diagnosis were at greater risk for off–therapy anxiety (OR=4.1; 95% CI, 1.31-12.73, p=0.022), and those with elevated depressive symptoms 6-months post-diagnosis were at greater risk for off-therapy depression (OR=7.88, 95% CI, 2.61-23.81, p=0.0002). In adjusted longitudinal analyses, unhealthy family functioning (p=0.008), and less reliance on social support coping (p=0.009) were associated with risk for emotional distress. Children from Spanish-speaking families (p=0.05) were also at greater risk for distress. Conclusions A significant proportion of children experience emotional distress during and after therapy for ALL. These data provide a compelling rationale for targeted early screening, and psychosocial interventions to support family functioning and coping skills. PMID:27028090

The longitudinal relationship between motor competence and measures of fatness and fitness from childhood into adolescence.

PubMed

Lima, Rodrigo Antunes; Bugge, Anna; Ersbøll, Annette K; Stodden, David F; Andersen, Lars B

2018-05-18

To examine longitudinal (seven years) relationships among cardiorespiratory fitness (VO 2peak ), body fatness, and motor competence. Data were collected as part of the Copenhagen School Child Intervention Study (CoSCIS). Body fatness was assessed by the sum of four skinfolds. VO 2peak was measured directly in a continuous running protocol. Motor competence was assessed using the Körperkoordinationtest für Kinder. This study used multilevel linear mixed models to evaluate the reciprocal longitudinal association between body fatness, VO 2peak , and motor competence. All regressions were stratified by sex and adjusted by intervention and pubertal status. All variable coefficients were standardized. A reciprocal relationship was observed between children's motor competence with body fatness and VO 2peak at the seven-year follow-up (6-13 years of age). Children with higher motor competence at baseline had a lower risk of having higher body fatness (β boys =-0.45, 95% CI: -0.52 to -0.38; β girls =-0.35, 95% CI: -0.42 to -0.28) and higher VO 2peak (β boys =0.34, 95% CI: 0.27-0.40; β girls =0.27, 95% CI: 0.20-0.33) during childhood. Alternatively, higher body fatness or lower levels of VO 2peak at baseline were associated with lower motor competence during childhood. These data suggest motor competence, body fatness, and VO 2peak demonstrate reciprocal relationships across childhood (6-13 years of age). Interventions addressing motor competence, cardiorespiratory fitness, and body fatness in early childhood are recommended, as intervention effects are likely to be enhanced because of the mutual reciprocal associations between these three variables. Copyright © 2018. Published by Elsevier Editora Ltda.

Patient Core Data Set. Standard for a longitudinal health/medical record.

PubMed

Renner, A L; Swart, J C

1997-01-01

Blue Chip Computers Company, in collaboration with Wright State University-Miami Valley College of Nursing and Health, with support from the Agency for Health Care Policy and Research, Public Health Service, completed Small Business innovative Research research to design a comprehensive integrated Patient information System. The Wright State University consultants undertook the development of a Patient Core Data Set (PCDS) in response to the lack of uniform standards of minimum data sets, and lack of standards in data transfer for continuity of care. The purpose of the Patient Core Data Set is to develop a longitudinal patient health record and medical history using a common set of standard data elements with uniform definitions and coding consistent with Health Level 7 (HL7) protocol and the American Society for Testing and Materials (ASTM) standards. The PCDS, intended for transfer across all patient-care settings, is essential information for clinicians, administrators, researchers, and health policy makers.

Biofeedback to Promote Movement Symmetry After Total Knee Arthroplasty: A Feasibility Study

PubMed Central

ZENI, JOSEPH; ABUJABER, SUMAYAH; FLOWERS, PORTIA; POZZI, FEDERICO; SNYDER-MACKLER, LYNN

2014-01-01

STUDY DESIGN Prospective analysis of a longitudinal cohort with an embedded comparison group at a single time point. OBJECTIVES To determine the feasibility and effectiveness of an outpatient rehabilitation protocol that includes movement symmetry biofeedback on functional and biomechanical outcomes after total knee arthroplasty (TKA). BACKGROUND TKA reduces pain and improves functional ability, but many patients experience strength deficits and movement abnormalities in the operated limb, despite outpatient rehabilitation. These asymmetries increase load on the nonoperated limb, and greater asymmetry is related to worse functional outcomes. METHODS Biomechanical and functional metrics were assessed 2 to 3 weeks prior to TKA, at discharge from outpatient physical therapy, and 6 months after TKA in 11 patients (9 men, 2 women; mean ± SD age, 61.4 ± 5.8 years; body mass index, 33.1 ± 5.4 kg/m2) who received 6 to 8 weeks of outpatient physical therapy that included specialized symmetry training. Six-month outcomes were compared to a control group, matched by age, body mass index, and sex (9 men, 2 women; mean ± SD age, 61.8 ± 5 years; body mass index, 34.3 ± 5.1 kg/m2), that did not receive specialized symmetry retraining. RESULTS Of the 11 patients who received added symmetry training, 9 demonstrated clinically meaningful improvements that exceeded the minimal detectable change for all performance-based functional tests at 6 months post-TKA compared to pre-TKA. Six months after TKA, when walking, patients who underwent symmetry retraining had greater knee extension during midstance and had mean sagittal knee moments that were more symmetrical, biphasic, and more representative of normal knee kinetics compared to patients who did not undergo symmetry training. No patients experienced adverse events as the result of the protocol. CONCLUSION Adding symmetry retraining to postoperative protocols is clinically viable, safe, and may have additional benefits compared to rehabilitation protocols that focus on range of motion, strength, and return to independence. PMID:23892267

A bespoke mobile application for the longitudinal assessment of depression and mood during pregnancy: protocol of a feasibility study.

PubMed

Marcano Belisario, Jose Salvador; Doherty, Kevin; O'Donoghue, John; Ramchandani, Paul; Majeed, Azeem; Doherty, Gavin; Morrison, Cecily; Car, Josip

2017-05-29

Depression is a common mental health disorder during pregnancy, with important consequences for mothers and their children. Despite this, it goes undiagnosed and untreated in many women attending antenatal care. Smartphones could help support the prompt identification of antenatal depression in this setting. In addition, these devices enable the implementation of ecological momentary assessment techniques, which could be used to assess how mood is experienced during pregnancy. With this study, we will assess the feasibility of using a bespoke mobile application (app) running on participants' own handsets for the longitudinal (6 months) monitoring of antenatal mood and screening of depression. We will use a randomised controlled study design to compare two types of assessment strategies: retrospective + momentary (consisting of the Edinburgh Postnatal Depression Scale plus five momentary and two contextual questions), and retrospective (consisting of the Edinburgh Postnatal Depression Scale only). We will assess the impact that these strategies have on participant adherence to a prespecified sampling protocol, dropout rates and timeliness of data completion. We will evaluate differences in acceptance of the technology through a short quantitative survey and open-ended questions. We will also assess the potential effect that momentary assessments could have on retrospective data. We will attempt to identify any patterns in app usage through the analysis of log data. This study has been reviewed and approved by the National Research Ethics Service Committee South East Coast-Surrey on 15 April 2016 as a notice of substantial amendment to the original submission (9 July 2015) under the Research Ethics Committee (REC) reference 15/LO/0977. This study is being sponsored by Imperial College London under the reference number 15IC2687 and has been included in the UK Clinical Research Network Study Portfolio under the Central Portfolio Management System number 19280. The findings of this study will be disseminated through academic peer-reviewed publications, poster presentations and abstracts at academic and professional conferences, discussion with peers, and social media. The findings of this study will also inform the PhD theses of JSMB and KD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Consistent and reproducible positioning in longitudinal imaging for phenotyping genetically modified swine

NASA Astrophysics Data System (ADS)

Hammond, Emily; Dilger, Samantha K. N.; Stoyles, Nicholas; Judisch, Alexandra; Morgan, John; Sieren, Jessica C.

2015-03-01

Recent growth of genetic disease models in swine has presented the opportunity to advance translation of developed imaging protocols, while characterizing the genotype to phenotype relationship. Repeated imaging with multiple clinical modalities provides non-invasive detection, diagnosis, and monitoring of disease to accomplish these goals; however, longitudinal scanning requires repeatable and reproducible positioning of the animals. A modular positioning unit was designed to provide a fixed, stable base for the anesthetized animal through transit and imaging. Post ventilation and sedation, animals were placed supine in the unit and monitored for consistent vitals. Comprehensive imaging was performed with a computed tomography (CT) chest-abdomen-pelvis scan at each screening time point. Longitudinal images were rigidly registered, accounting for rotation, translation, and anisotropic scaling, and the skeleton was isolated using a basic thresholding algorithm. Assessment of alignment was quantified via eleven pairs of corresponding points on the skeleton with the first time point as the reference. Results were obtained with five animals over five screening time points. The developed unit aided in skeletal alignment within an average of 13.13 +/- 6.7 mm for all five subjects providing a strong foundation for developing qualitative and quantitative methods of disease tracking.

Parental engagement and early interactions with preterm infants during the stay in the neonatal intensive care unit: protocol of a mixed-method and longitudinal study

PubMed Central

Stefana, Alberto; Lavelli, Manuela

2017-01-01

Introduction The preterm infants' developmental outcomes depend on biological and environmental risk factors. The environmental factors include prolonged parental separation, less exposure to early mother/father–infant interactions and the parents' ability to respond to the trauma of premature birth. In the case of premature birth, the father's ability to take an active part in the care of the infant from the start is essential. The parents' emotional closeness to the preterm infant hospitalised in the neonatal intensive care unit (NICU) may be crucial to the well-being of the newborn, the development of mutual regulation, the establishment of a functioning parent–infant affective relationship and the parents' confidence in their ability to provide care for their baby. Methods and analysis This is a mixed-method, observational and longitudinal study. The methodological strategy will include: (1) ethnographic observation in a level III NICU located in Italy for a duration of 18 months; (2) 3-minute video recordings of mother–infant and father–infant interaction in the NICU; (3) a semistructured interview with fathers during the infants' hospital stay; (4) 3-minute video recordings of mother–infant and father–infant face-to-face interaction in the laboratory at 4 months of corrected age; (5) self-report questionnaires for parents on depression and quality of the couple relationship at the approximate times of the video recording sessions. Ethics and dissemination The study protocol was approved by the Ethical Committee for Clinical Trials of the Verona and Rovigo Provinces. Results aim to be published in international peer-reviewed journals, and presented at relevant national and international conferences. This research project will develop research relevant to (1) the quality and modalities of maternal and paternal communication with the preterm infant in the NICU; (2) the influence of maternal/paternal social stimulation on the infant behavioural states; (3) the quality and modalities of paternal support to the partner and possible influences on mother–infant relationship. PMID:28153932

Quantitative MRI establishes the efficacy of PI3K inhibitor (GDC-0941) multi-treatments in PTEN-deficient mice lymphoma.

PubMed

Wullschleger, Stephan; García-Martínez, Juan M; Duce, Suzanne L

2012-02-01

To assess the efficacy of multiple treatment of phosphatidylinositol-3-kinase (PI3K) inhibitor on autochthonous tumours in phosphatase and tensin homologue (Pten)-deficient genetically engineered mouse cancer models using a longitudinal magnetic resonance imaging (MRI) protocol. Using 3D MRI, B-cell follicular lymphoma growth was quantified in a Pten(+/-)Lkb1(+/hypo) mouse line, before, during and after repeated treatments with a PI3K inhibitor GDC-0941 (75 mg/kg). Mean pre-treatment linear tumour growth rate was 16.5±12.8 mm(3)/week. Repeated 28-day GDC-0941 administration, with 21 days 'off-treatment', induced average tumour regression of 41±7%. Upon cessation of the second treatment (which was not permanently cytocidal), tumours re-grew with an average linear growth rate of 40.1±15.5 mm(3)/week. There was no evidence of chemoresistance. This protocol can accommodate complex dosing schedules, as well as combine different cancer therapies. It reduces biological variability problems and resulted in a 10-fold reduction in mouse numbers compared with terminal assessment methods. It is ideal for preclinical efficacy studies and for phenotyping molecularly characterized mouse models when investigating gene function.

Validation of Non-Invasive Tracer Kinetic Analysis of 18F-Florbetaben PET Using a Dual Time-Window Acquisition Protocol.

PubMed

Bullich, Santiago; Barthel, Henryk; Koglin, Norman; Becker, Georg A; De Santi, Susan; Jovalekic, Aleksandar; Stephens, Andrew W; Sabri, Osama

2017-11-24

Accurate amyloid PET quantification is necessary for monitoring amyloid-beta accumulation and response to therapy. Currently, most of the studies are analyzed using the static standardized uptake value ratio (SUVR) approach because of its simplicity. However, this approach may be influenced by changes in cerebral blood flow (CBF) or radiotracer clearance. Full tracer kinetic models require arterial blood sampling and dynamic image acquisition. The objectives of this work were: (1) to validate a non-invasive kinetic modeling approach for 18 F-florbetaben PET using an acquisition protocol with the best compromise between quantification accuracy and simplicity and (2) to assess the impact of CBF changes and radiotracer clearance on SUVRs and non-invasive kinetic modeling data in 18 F-florbetaben PET. Methods: Data from twenty subjects (10 patients with probable Alzheimer's dementia/ 10 healthy volunteers) were used to compare the binding potential (BP ND ) obtained from the full kinetic analysis to the SUVR and to non-invasive tracer kinetic methods (simplified reference tissue model (SRTM), and multilinear reference tissue model 2 (MRTM2)). Different approaches using shortened or interrupted acquisitions were compared to the results of the full acquisition (0-140 min). Simulations were carried out to assess the effect of CBF and radiotracer clearance changes on SUVRs and non-invasive kinetic modeling outputs. Results: A 0-30 and 120-140 min dual time-window acquisition protocol using appropriate interpolation of the missing time points provided the best compromise between patient comfort and quantification accuracy. Excellent agreement was found between BP ND obtained using full and dual time-window (2TW) acquisition protocols (BP ND,2TW =0.01+ 1.00 BP ND,FULL , R2=0.97 (MRTM2); BP ND,2TW = 0.05+ 0.92·BP ND,FULL , R2=0.93 (SRTM)). Simulations showed a limited impact of CBF and radiotracer clearance changes on MRTM parameters and SUVRs. Conclusion: This study demonstrates accurate non-invasive kinetic modeling of 18 F-florbetaben PET data using a dual time-window acquisition protocol, thus providing a good compromise between quantification accuracy, scan duration and patient burden. The influence of CBF and radiotracer clearance changes on amyloid-beta load estimates was small. For most clinical research applications, the SUVR approach is appropriate. However, for longitudinal studies in which a maximum quantification accuracy is desired, this non-invasive dual time-window acquisition protocol and kinetic analysis is recommended. Copyright © 2017 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study

PubMed Central

Chandler, Melanie; Locke, Dona EC; Fields, Julie; Phatak, Vaishali; Crook, Julia; Hanna, Sherrie; Lunde, Angela; Morris, Miranda; Graff-Radford, Michelle; Hughes, Christine A; Lepore, Susan; Cuc, Andrea; Caselli, Maria; Hurst, Duane; Wethe, Jennifer; Francone, Andrea; Eilertsen, Jeanne; Lucas, Pauline; Hoffman Snyder, Charlene; Kuang, LeeAnn; Becker, Marigrace; Dean, Pamela; Diehl, Nancy; Lofquist, Marvin; Vanderhook, Shirley; Myles, Diana; Cochran, Denise

2017-01-01

Background Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. Objective The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. Methods This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. Results In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. Conclusions This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial. Trial Registration  ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv) PMID:29180344

A prospective, longitudinal study of growth, nutrition and sedentary behaviour in young children with cerebral palsy.

PubMed

Bell, Kristie L; Boyd, Roslyn N; Tweedy, Sean M; Weir, Kelly A; Stevenson, Richard D; Davies, Peter S W

2010-04-06

Cerebral palsy is the most common cause of physical disability in childhood, occurring in one in 500 children. It is caused by a static brain lesion in the neonatal period leading to a range of activity limitations. Oral motor and swallowing dysfunction, poor nutritional status and poor growth are reported frequently in young children with cerebral palsy and may impact detrimentally on physical and cognitive development, health care utilisation, participation and quality of life in later childhood. The impact of modifiable factors (dietary intake and physical activity) on growth, nutritional status, and body composition (taking into account motor severity) in this population is poorly understood. This study aims to investigate the relationship between a range of factors - linear growth, body composition, oral motor and feeding dysfunction, dietary intake, and time spent sedentary (adjusting for motor severity) - and health outcomes, health care utilisation, participation and quality of life in young children with cerebral palsy (from corrected age of 18 months to 5 years). This prospective, longitudinal, population-based study aims to recruit a total of 240 young children with cerebral palsy born in Queensland, Australia between 1st September 2006 and 31st December 2009 (80 from each birth year). Data collection will occur at three time points for each child: 17 - 25 months corrected age, 36 +/- 1 months and 60 +/- 1 months. Outcomes to be assessed include linear growth, body weight, body composition, dietary intake, oral motor function and feeding ability, time spent sedentary, participation, medical resource use and quality of life. This protocol describes a study that will provide the first longitudinal description of the relationship between functional attainment and modifiable lifestyle factors (dietary intake and habitual time spent sedentary) and their impact on the growth, body composition and nutritional status of young children with cerebral palsy across all levels of functional ability.

A prospective, longitudinal study of growth, nutrition and sedentary behaviour in young children with cerebral palsy

PubMed Central

2010-01-01

Background Cerebral palsy is the most common cause of physical disability in childhood, occurring in one in 500 children. It is caused by a static brain lesion in the neonatal period leading to a range of activity limitations. Oral motor and swallowing dysfunction, poor nutritional status and poor growth are reported frequently in young children with cerebral palsy and may impact detrimentally on physical and cognitive development, health care utilisation, participation and quality of life in later childhood. The impact of modifiable factors (dietary intake and physical activity) on growth, nutritional status, and body composition (taking into account motor severity) in this population is poorly understood. This study aims to investigate the relationship between a range of factors - linear growth, body composition, oral motor and feeding dysfunction, dietary intake, and time spent sedentary (adjusting for motor severity) - and health outcomes, health care utilisation, participation and quality of life in young children with cerebral palsy (from corrected age of 18 months to 5 years). Design/Methods This prospective, longitudinal, population-based study aims to recruit a total of 240 young children with cerebral palsy born in Queensland, Australia between 1st September 2006 and 31st December 2009 (80 from each birth year). Data collection will occur at three time points for each child: 17 - 25 months corrected age, 36 ± 1 months and 60 ± 1 months. Outcomes to be assessed include linear growth, body weight, body composition, dietary intake, oral motor function and feeding ability, time spent sedentary, participation, medical resource use and quality of life. Discussion This protocol describes a study that will provide the first longitudinal description of the relationship between functional attainment and modifiable lifestyle factors (dietary intake and habitual time spent sedentary) and their impact on the growth, body composition and nutritional status of young children with cerebral palsy across all levels of functional ability. PMID:20370929

Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial.

PubMed

Bulteau, Samuel; Sébille, Veronique; Fayet, Guillemette; Thomas-Ollivier, Veronique; Deschamps, Thibault; Bonnin-Rivalland, Annabelle; Laforgue, Edouard; Pichot, Anne; Valrivière, Pierre; Auffray-Calvier, Elisabeth; Fortin, June; Péréon, Yann; Vanelle, Jean-Marie; Sauvaget, Anne

2017-01-13

The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression. This paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements). The purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression. ClinicalTrials.gov, Identifier NCT02376491 . Registered on 17 February 2015 at http://clinicaltrials.gov .

The experiences, unmet needs and outcomes of parents of severely injured children: a longitudinal mixed methods study protocol.

PubMed

Foster, Kim; Curtis, Kate; Mitchell, Rebecca; Van, Connie; Young, Alexandra

2016-09-06

Being the parent of a severely injured child involves many stressors throughout the trauma journey. Internationally, little is known about the experiences or levels of emotional distress, parenting stress, quality of life, and resilience for parents of injured children. The aim of this study is to investigate the experiences, unmet needs and outcomes of parents of physically injured children 0-12 years over the 2 year period following injury. This is a prospective longitudinal study using an embedded mixed methods design. This design has a primary qualitative strand which incorporates supplementary quantitative data on child quality of life, and parental quality of life, parenting stress, emotional distress, and resilience at four time points; the acute hospitalisation phase, and at 6, 12 and 24 months following injury. The primary sample are parents of injured children 0-12 years hospitalised in the Australian states of New South Wales, Queensland, Victoria and South Australia. Primary data sources are child and parent demographic data; survey data; and semi-structured interview data across a 24 month period. This study aims to address the existing gap in knowledge on the experiences and unmet support needs of parents in the 2 years following child injury to provide guidance for care provision for these families. There is a lack of evidence-based recommendations for supporting parents and families of injured children and strengthening their capacity to address the challenges they face.

A longitudinal twin study on IQ, executive functioning, and attention problems during childhood and early adolescence.

PubMed

Polderman, Tinca J C; Gosso, M Florencia; Posthuma, Danielle; Van Beijsterveldt, Toos C E M; Heutink, Peter; Verhulst, Frank C; Boomsma, Dorret I

2006-12-01

Variation in human behavior may be caused by differences in genotype and by non-genetic differences ("environment") between individuals. The relative contributions of genotype (G) and environment (E) to phenotypic variation can be assessed with the classical twin design. We illustrate this approach with longitudinal data collected in 5 and 12-year-old Dutch twins. At age 5 data on cognitive abilities as assessed with a standard intelligence test (IQ), working memory, selective and sustained attention, and attention problems were collected in 237 twin pairs. Seven years later, 172 twin pairs participated again when they were 12 years old and underwent a similar protocol. Results showed that variation in all phenotypes was influenced by genetic factors. For IQ the heritability estimates increased from 30% at age 5, to 80% at age 12. For executive functioning performance genetic factors accounted for around 50% of the variance at both ages. Attention problems showed high heritabilities (above 60%) at both ages, for maternal and teacher ratings. Longitudinal analyses revealed that executive functioning during childhood was weakly correlated with IQ scores at age 12. Attention problems during childhood, as rated by the mother and the teacher were stronger predictors (r = -0.28 and -0.36, respectively). This association could be attributed to a partly overlapping set of genes influencing attention problems at age 5 and IQ at age 12. IQ performance at age 5 was the best predictor of IQ at age 12. IQ at both ages was influenced by the same genes, whose influence was amplified during development.

Project YOURLIFE (What Young People Think and Feel about Relationships, Love, Sexuality, and Related Risk Behavior): Cross-sectional and Longitudinal Protocol.

PubMed

Carlos, Silvia; Osorio, Alfonso; Calatrava, María; Lopez-Del Burgo, Cristina; Ruiz-Canela, Miguel; de Irala, Jokin

2016-01-01

Sexually transmitted infections and unplanned pregnancies affect adolescent sexual health and are serious public health concerns. They result from sexual intercourse in adolescence, which is usually associated with multiple partners, unprotected sex, and condom misuse. This behavior is related to socio-ecological factors that influence lifestyles. The YOURLIFE project aims to find out what young people think and feel about relationships, love, and sexuality, and to assess the associations between these thoughts and attitudes, adolescents' social factors, and sexual health. An international school-based study with a cross-sectional and optional subsequent longitudinal design. Three online questionnaires designed for adolescents aged 13/14, 15/16, and 17/18, respectively, will be used. A matching coding system will allow longitudinal follow-up when adolescents reply to follow-up surveys. Questionnaires will include questions related to sociodemographic data; information/communication technologies; leisure time; parental supervision; influences of parents/friends; information sources; messages perceived; and sexuality-related knowledge, attitudes, and opinions. The second and third questionnaires for participants aged 15/16 and 17/18 will also contain variables concerning sexual behavior. Schools will be able to use their results to tailor educational approaches targeting the needs of their students. Multivariate analyses will be performed using the larger international dataset. The YOURLIFE project will collect comprehensive information about the socio-ecological determinants of the sexual risk-taking of schooled adolescents worldwide. Effective preventive programs could be subsequently designed and tailored to the specific determinants of adolescents from different schools and settings, and also, when analyzed globally, to public health professionals.

Chronic kidney disease in Asia: Protocol for a collaborative overview.

PubMed

Liyanage, Thaminda; Ninomiya, Toshiharu; Perkovic, Vlado; Woodward, Mark; Stirnadel-Farrant, Heide; Matsushita, Kunihiro; Iseki, Kunitoshi; Seong, Hooi Lai; Monaghan, Helen; Jha, Vivekanand

2017-06-01

The burden of chronic kidney disease (CKD) is growing rapidly around the world. However, there is limited information on the overall regional prevalence of CKD, as well as the prognostic implications and treatment patterns in Asian region. We have established the Asian Renal Collaboration (ARC) with the goal of consolidating region-wide data regarding CKD. This collaborative project will synthesize data and perform meta-analyses of observational studies conducted in Asia. Studies will be identified through a systematic literature search including abstracts, proceedings of meetings, electronic databases such as MEDLINE and EMBASE. Personal enquiry among collaborators and experts in the region will identify additional studies, or other data sources such as registries. Both cross-sectional and longitudinal studies that describe the prevalence of CKD and its complications will be included, as will longitudinal studies that describe important clinical outcomes for people with CKD. Individual participant data will be sought, where possible, from each of the studies included in the collaboration for baseline parameters and subsequent outcomes, in order to maximize flexibility and consistency of data analyses. This study is an initiative offering a unique opportunity to obtain information about the prevalence and manifestations of CKD in Asia, as well as its risk factors. The ARC will also provide insights into important outcomes including progression of CKD, CKD complications, cardiovascular disease and death. These findings will improve our understanding of kidney disease in Asia, and thus help inform service provision, preventive care and further research across the region. © 2016 Asian Pacific Society of Nephrology.

Leveraging Electronic Health Care Record Information to Measure Pressure Ulcer Risk in Veterans With Spinal Cord Injury: A Longitudinal Study Protocol.

PubMed

Luther, Stephen L; Thomason, Susan S; Sabharwal, Sunil; Finch, Dezon K; McCart, James; Toyinbo, Peter; Bouayad, Lina; Matheny, Michael E; Gobbel, Glenn T; Powell-Cope, Gail

2017-01-19

Pressure ulcers (PrUs) are a frequent, serious, and costly complication for veterans with spinal cord injury (SCI). The health care team should periodically identify PrU risk, although there is no tool in the literature that has been found to be reliable, valid, and sensitive enough to assess risk in this vulnerable population. The immediate goal is to develop a risk assessment model that validly estimates the probability of developing a PrU. The long-term goal is to assist veterans with SCI and their providers in preventing PrUs through an automated system of risk assessment integrated into the veteran's electronic health record (EHR). This 5-year longitudinal, retrospective, cohort study targets 12,344 veterans with SCI who were cared for in the Veterans Health Administration (VHA) in fiscal year (FY) 2009 and had no record of a PrU in the prior 12 months. Potential risk factors identified in the literature were reviewed by an expert panel that prioritized factors and determined if these were found in structured data or unstructured form in narrative clinical notes for FY 2009-2013. These data are from the VHA enterprise Corporate Data Warehouse that is derived from the EHR structured (ie, coded in database/table) or narrative (ie, text in clinical notes) data for FY 2009-2013. This study is ongoing and final results are expected in 2017. Thus far, the expert panel reviewed the initial list of risk factors extracted from the literature; the panel recommended additions and omissions and provided insights about the format in which the documentation of the risk factors might exist in the EHR. This list was then iteratively refined through review and discussed with individual experts in the field. The cohort for the study was then identified, and all structured, unstructured, and semistructured data were extracted. Annotation schemas were developed, samples of documents were extracted, and annotations are ongoing. Operational definitions of structured data elements have been created and steps to create an analytic dataset are underway. To our knowledge, this is the largest cohort employed to identify PrU risk factors in the United States. It also represents the first time natural language processing and statistical text mining will be used to expand the number of variables available for analysis. A major strength of this quantitative study is that all VHA SCI centers were included in the analysis, reducing potential for selection bias and providing increased power for complex statistical analyses. This longitudinal study will eventually result in a risk prediction tool to assess PrU risk that is reliable and valid, and that is sensitive to this vulnerable population. ©Stephen L Luther, Susan S Thomason, Sunil Sabharwal, Dezon K Finch, James McCart, Peter Toyinbo, Lina Bouayad, Michael E Matheny, Glenn T Gobbel, Gail Powell-Cope. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.01.2017.

Assessing competence: the European Survey on Aging Protocol (ESAP).

PubMed

Fernández-Ballesteros, Rocío; Zamarrón, María Dolores; Rudinger, Georg; Schroots, Johannes J F; Hekkinnen, Eino; Drusini, Andrea; Paul, Constanza; Charzewska, Jadwiga; Rosenmayr, Leopold

2004-01-01

The main goal of this research project was to translate and adapt the European Survey on Ageing Protocol (ESAP) to 7 European countries/cultures. This article presents preliminary results from the ESAP, the basic assessment instrument of EXCELSA (European Longitudinal Study of Aging). 672 individuals aged 30-85, selected through quota sampling (by age, gender, education and living conditions), participated in this study, with 96 subjects from each of the 7 European countries. The basic research protocol for assessing competence and its determinants was designed to be administered in a 90-min in-home face-to-face interview. It contains a series of questions, instruments, scales and physical tests assessing social relationships and caregiving, mental abilities, well-being, personality, mastery and perceived control, self-reported health, lifestyles, anthropometry, biobehavioral measures and sociodemographic variables. 84% of ESAP measures are age-dependent and 75% of them discriminate between education levels. Minor differences were found due to gender, and between people living in rural and urban areas. Exploratory factor analysis yielded 10 factors accounting for 67.85% of total variance, one of which was identified as cognitive and physical 'competence'. This factorial structure was tested across countries through concordance coefficients. Finally, using structural equation modeling, our data were fitted into a model of competence. When the sample was split into younger groups (aged 30-49 years) and older ones (50 and more years), the same model was appropriate for our data. The results are discussed in accordance with other findings on psychosocial, biophysical and sociodemographic components of competence, and also in accordance with theories on competence and successful aging. Copyright 2004 S. Karger AG, Basel

Optimized magnetic resonance diffusion protocol for ex-vivo whole human brain imaging with a clinical scanner

NASA Astrophysics Data System (ADS)

Scherrer, Benoit; Afacan, Onur; Stamm, Aymeric; Singh, Jolene; Warfield, Simon K.

2015-03-01

Diffusion-weighted magnetic resonance imaging (DW-MRI) provides a novel insight into the brain to facilitate our understanding of the brain connectivity and microstructure. While in-vivo DW-MRI enables imaging of living patients and longitudinal studies of brain changes, post-mortem ex-vivo DW-MRI has numerous advantages. Ex-vivo imaging benefits from greater resolution and sensitivity due to the lack of imaging time constraints; the use of tighter fitting coils; and the lack of movement artifacts. This allows characterization of normal and abnormal tissues with unprecedented resolution and sensitivity, facilitating our ability to investigate anatomical structures that are inaccessible in-vivo. This also offers the opportunity to develop today novel imaging biomarkers that will, with tomorrow's MR technology, enable improved in-vivo assessment of the risk of disease in an individual. Post-mortem studies, however, generally rely on the fixation of specimen to inhibit tissue decay which starts as soon as tissue is deprived from its blood supply. Unfortunately, fixation of tissues substantially alters tissue diffusivity profiles. In addition, ex-vivo DW-MRI requires particular care when packaging the specimen because the presence of microscopic air bubbles gives rise to geometric and intensity image distortion. In this work, we considered the specific requirements of post-mortem imaging and designed an optimized protocol for ex-vivo whole brain DW-MRI using a human clinical 3T scanner. Human clinical 3T scanners are available to a large number of researchers and, unlike most animal scanners, have a bore diameter large enough to image a whole human brain. Our optimized protocol will facilitate widespread ex-vivo investigations of large specimen.

Mustard gas or sulfur mustard: an old chemical agent as a new terrorist threat.

PubMed

Wattana, Monica; Bey, Tareg

2009-01-01

Sulfur mustard is a member of the vesicant class of chemical warfare agents that causes blistering to the skin and mucous membranes. There is no specific antidote, and treatment consists of systematically alleviating symptoms. Historically, sulfur mustard was used extensively in inter-governmental conflicts within the trenches of Belgium and France during World War I and during the Iran-Iraq conflict. Longitudinal studies of exposed victims show that sulfur mustard causes long-term effects leading to high morbidity. Given that only a small amount of sulfur mustard is necessary to potentially cause an enormous number of casualties, disaster-planning protocol necessitates the education and training of first-line healthcare responders in the recognition, decontamination, triage, and treatment of sulfur mustard-exposed victims in a large-scale scenario.

Motor competence and cardiorespiratory fitness have greater influence on body fatness than physical activity across time.

PubMed

Lima, R A; Pfeiffer, K A; Bugge, A; Møller, N C; Andersen, L B; Stodden, D F

2017-12-01

We investigated the longitudinal associations among physical activity (PA), motor competence (MC), cardiorespiratory fitness (VO 2peak ), and body fatness across 7 years, and also analyzed the possible mediation effects of PA, MC, and VO 2peak on the relationships with body fatness. This was a seven-year longitudinal study with three measuring points (mean ages [in years] and respective sample size: 6.75±0.37, n=696; 9.59±1.07, n=617; 13.35±0.34, n=513). PA (moderate-to-vigorous PA-MVPA and vigorous PA-VPA) was monitored using accelerometers. MC was assessed by the "Körperkoordinationstest für Kinder-KTK" test battery. VO 2peak was evaluated using a continuous running protocol until exhaustion. Body fatness was determined by the sum of four skinfolds. Structural equation modeling was performed to evaluate the longitudinal associations among PA, MC, VO 2peak, and body fatness and the potential mediation effects of PA, MC, and VO 2peak . All coefficients presented were standardized (z-scores). MC and VO 2peak directly influenced the development of body fatness, and VO 2peak mediated the associations between MVPA, VPA, MC, and body fatness. MC also mediated the associations between MVPA, VPA, and body fatness. In addition, VO 2peak had the largest total association with body fatness (β=-0.431; P<.05), followed by MC (β=-0.369; P<.05) and VPA (β=-0.112; P<.05). As PA, MC, and VO 2peak exhibited longitudinal association with body fatness, it seems logical that interventions should strive to promote the development of fitness and MC through developmentally appropriate physical activities, as the synergistic interactions of all three variables impacted body fatness. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Using and Interpreting Mental Health Measures in the National Social Life, Health, and Aging Project

PubMed Central

Payne, Carolyn; Hedberg, E. C.; Kozloski, Michael; Dale, William

2014-01-01

Introduction. National Social Life, Health, and Aging Project (NSHAP) included five unique mental health measures in Waves 1 and 2 that researchers can use to measure the overall emotional health of participants: depressive symptoms, happiness–unhappiness, anxiety symptoms, perceived stress, and felt loneliness. For each, we detail the rationale for its development and explain how to score, analyze, and interpret results. Method. NSHAP developed its measures by modifying traditional short-form scales to improve response efficiency and reduce respondent burden. Scoring protocols and interpretations were developed for each measure. U.S. population estimates for older adults born between 1920 and 1947 were generated using age-eligible samples from Waves 1 and 2. Results. NSHAP’s protocols yielded U.S. prevalence rates similar to other nationally representative studies of older adults and comparable between waves. Higher estimates of anxiety symptoms and perceived stress in Wave 2 compared with Wave 1 were explained by age, administration mode, and time period. Analytic strategies for longitudinal analyses are provided. In Wave 2, mental health generally was worse at older ages, with women having more symptoms at younger ages than men. Women had fewer anxiety symptoms at the oldest ages. Discussion. NSHAP’s mental health measures were successfully integrated into the project’s survey and showed acceptable external reliability as well as moderately stable individual characteristics across the 5 years between Waves 1 and 2. Depressive symptoms and unhappiness may form a mental health cluster in the elderly, distinct from anxiety symptoms, perceived stress, and felt loneliness. Gender differences in age-specific patterns of mental health were evident using the exact age of participants rather than the traditional decade groupings. Administration mode and time period (between 2005–2006 and 2010–2011) were determined to be potential confounds that need to be accommodated in longitudinal analyses of aging, whereas sample composition was not an issue for interpreting mental health measures. PMID:25360028

Glycosylated hemoglobin testing in the National Social Life, Health, and Aging Project.

PubMed

Gregg, Forest T; O'Doherty, Katie; Schumm, L Philip; McClintock, Martha K; Huang, Elbert S

2014-11-01

Longitudinal biomeasures of health are still new in nationally representative social science survey research. Data measuring blood sugar control provide opportunities for understanding the development of diabetes and its complications in older adults, but researchers must be aware that some of the differences across time can be due to variations in measurement procedures. This is a well-recognized issue whenever all samples cannot be assayed at the same time and we sought to present the analytic methods to quantify and adjust for the variation. We collected and analyzed HbA1C, glycated hemoglobin, a biomeasure of average blood sugar concentrations within the past few months. Improvements were made in the collection protocol for Wave 2, and assays were performed by a different lab. The HbA1C data obtained during Wave 1 and Wave 2 are consistent with the expected population distributions for differences by gender, age, race/ethnicity, and diabetes status. Age-adjusted mean HbA1C declined slightly from Wave 1 to Wave 2 by -0.19 (95% confidence interval [CI]: -0.27, -0.10), and the average longitudinal change was -0.12 (95% CI: -0.18, -0.06). Collection of HbA1C in Wave 2 permits researchers to examine the relationship between HbA1C and new health and social measures added in Wave 2, and to identify factors related to the change in HbA1C. Changes in collection protocol and labs between waves may have yielded small systematic differences that require analysts to carefully interpret absolute HbA1C values. We recommend analytic methods for cross wave differences in HbA1C and steps to ensure cross wave comparability in future studies. © The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Engagement and Retention of Suicide Attempters in Clinical Research

PubMed Central

Gibbons, Carly J.; Stirman, Shannon Wiltsey; Brown, Gregory K.; Beck, Aaron T.

2010-01-01

Background High attrition rates in longitudinal research can limit study generalizability, threaten internal validity, and decrease statistical power. Research has demonstrated that there can be significant differences between participants who complete a research study and those who drop out prematurely, and that treatment outcomes may be dependent on retention in a treatment protocol. Aims The current paper describes the challenges encountered when implementing a randomized controlled trial of cognitive therapy for the prevention of suicide attempts and the solutions developed to overcome these problems. Methods Problems unique to suicide attempters are discussed, and strategies successfully implemented to boost retention rates are provided. Results The methods implemented appeared to increase retention rates in the randomized controlled trial. Conclusions Many steps can be taken to work with this difficult population, and researchers are encouraged to be as involved and flexible with participants as possible. PMID:20418211

In Vivo Noninvasive Analysis of Human Forearm Muscle Function and Fatigue: Applications to EVA Operations and Training Maneuvers

NASA Technical Reports Server (NTRS)

Fotedar, L. K.; Marshburn, T.; Quast, M. J.; Feeback, D. L.

1999-01-01

Forearm muscle fatigue is one of the major limiting factors affecting endurance during performance of deep-space extravehicular activity (EVA) by crew members. Magnetic resonance (MR) provides in vivo noninvasive analysis of tissue level metabolism and fluid exchange dynamics in exercised forearm muscles through the monitoring of proton magnetic resonance imaging (MRI) and phosphorus magnetic resonance spectroscopy (P-31-MRS) parameter variations. Using a space glove box and EVA simulation protocols, we conducted a preliminary MRS/MRI study in a small group of human test subjects during submaximal exercise and recovery and following exhaustive exercise. In assessing simulated EVA-related muscle fatigue and function, this pilot study revealed substantial changes in the MR image longitudinal relaxation times (T2) as an indicator of specific muscle activation and proton flux as well as changes in spectral phosphocreatine-to-phosphate (PCr/Pi) levels as a function of tissue bioenergetic potential.

Acute kidney injury after contrast-enhanced examination among elderly1

PubMed Central

Aoki, Beatriz Bonadio; Fram, Dayana; Taminato, Mônica; Batista, Ruth Ester Sayad; Belasco, Angélica; Barbosa, Dulce Aparecida

2014-01-01

OBJECTIVES: to assess renal function in elderly patients undergoing contrast-enhanced computed tomography and identify the preventive measures of acute kidney injury in the period before and after the examination. METHOD: longitudinal cohort study conducted at the Federal University of São Paulo Hospital, from March 2011 to March 2013. All hospitalized elderly, of both sexes, aged 60 years and above, who performed the examination, were included (n=93). We collected sociodemographic data, data related to the examination and to the care provided, and creatinine values prior and post exam. RESULTS: an alteration in renal function was observed in 51 patients (54%) with a statistically significant increase of creatinine values (p<0.04), and two patients (4.0%) required hemodialysis. CONCLUSION: There is an urgent need for protocols prior to and post contrast-enhanced examination in the elderly, and other studies to verify the prognosis of this population. PMID:25296148

Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study.

PubMed

Smith, Glenn; Chandler, Melanie; Locke, Dona Ec; Fields, Julie; Phatak, Vaishali; Crook, Julia; Hanna, Sherrie; Lunde, Angela; Morris, Miranda; Graff-Radford, Michelle; Hughes, Christine A; Lepore, Susan; Cuc, Andrea; Caselli, Maria; Hurst, Duane; Wethe, Jennifer; Francone, Andrea; Eilertsen, Jeanne; Lucas, Pauline; Hoffman Snyder, Charlene; Kuang, LeeAnn; Becker, Marigrace; Dean, Pamela; Diehl, Nancy; Lofquist, Marvin; Vanderhook, Shirley; Myles, Diana; Cochran, Denise

2017-11-27

Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial.  ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv). ©Glenn Smith, Melanie Chandler, Dona EC Locke, Julie Fields, Vaishali Phatak, Julia Crook, Sherrie Hanna, Angela Lunde, Miranda Morris, Michelle Graff-Radford, Christine A Hughes, Susan Lepore, Andrea Cuc, Maria Caselli, Duane Hurst, Jennifer Wethe, Andrea Francone, Jeanne Eilertsen, Pauline Lucas, Charlene Hoffman Snyder, LeeAnn Kuang, Marigrace Becker, Pamela Dean, Nancy Diehl, Marvin Lofquist, Shirley Vanderhook, Diana Myles, Denise Cochran. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.11.2017.

Cranial magnetic resonance imaging (MRI) in elderly American Indians: Design, methods, and implementation of the Cerebrovascular Disease and its Consequences in American Indians Study

PubMed Central

Suchy-Dicey, Astrid M.; Shibata, Dean; Best, Lyle G.; Verney, Steven P.; Longstreth, W.T.; Lee, Elisa T.; Okin, Peter M.; Devereux, Richard; O’Leary, Marcia; Ali, Tauqeer; Jensen, Paul N.; Muller, Clemma; Nelson, Lonnie A.; Rhoades, Everett; Madhyastha, Tara; Grabowski, Thomas J.; Beauchamp, Norman; Umans, Jason G.; Buchwald, Dedra

2016-01-01

The Cerebrovascular Disease and Its Consequences in American Indians (CDCAI) Study recruited surviving members of a 20-year, longitudinal, population-based cohort of American Indians focused on cardiovascular disease, its risk factors, and its consequences. The goal of CDCAI Study is to characterize the burden, risk factors, and manifestations of vascular brain injury identified on cranial magnetic resonance imaging (MRI). CDCAI Study investigators enrolled 1,033 participants aged 60 years and older from 11 American Indian communities and tribes in the Northern Plains, Southern Plains, and Southwestern U.S. In addition to cranial MRI performed according to standardized protocols, participants underwent extensive medical interview, clinical examination, neurocognitive testing, physical function evaluation, electrocardiogram, and provided blood and urine specimens. Participants also self-administered questionnaires covering demographics, quality of life, and medical history. This report describes the design, implementation, and some of the unique challenges of this study and data collection. PMID:27603047

Transdisciplinary research for impact: protocol for a realist evaluation of the relationship between transdisciplinary research collaboration and knowledge translation

PubMed Central

Archibald, Mandy M; Harvey, Gillian; Kitson, Alison L

2018-01-01

Introduction Transdisciplinary teams are increasingly regarded as integral to conducting effective research. Similarly, knowledge translation is often seen as a solution to improving the relevance and benefits of health research. Yet, whether, how, for whom and under which circumstances transdisciplinary research influences knowledge translation is undertheorised, which limits its potential impact. The proposed research aims to identify the contexts and mechanisms by which transdisciplinary research contributes to developing shared understandings and behaviours of knowledge translation between team members. Methods and analysis Using a longitudinal case-study design approach to realist evaluation, we outline a study protocol examining whether, how, if and for whom transdisciplinary collaboration can impact knowledge translation understandings and behaviours within a 5-year transdisciplinary Centre of Research Excellence. Data are being collected between February 2017 and December 2020 over four rounds of theory development, refinement and testing using interviews, observation, document review and visual elicitation as data sources. Ethics and dissemination The Health Research Ethics Committee of the University of Adelaide approved this study. Findings will be communicated with team members at scheduled intervals throughout the study verbally and by means of creative reflective approaches (eg, arts elicitation, journalling). This research will be used to help support optimal team functioning by identifying strategies to support knowledge sharing and communication within and beyond the team to facilitate attainment of research objectives. Academic dissemination will occur through publication and presentations. PMID:29627820

Altitude exposure in sports: the Athlete Biological Passport standpoint.

PubMed

Sanchis-Gomar, Fabian; Pareja-Galeano, Helios; Brioche, Thomas; Martinez-Bello, Vladimir; Lippi, Giuseppe

2014-03-01

The Athlete Biological Passport (ABP) is principally founded on monitoring an athlete's biological variables over time, to identify abnormal biases on a longitudinal basis. Several factors are known to influence the results of these markers. However, the manner in which the altitude factor is taken into account still needs to be standardized. Causal relationships between haematological variables should be correctly integrated into ABP software. In particular, modifications of haematological parameters during and after exposure to different altitudes/hypoxic protocols need to be properly included within detection models. Copyright © 2013 John Wiley & Sons, Ltd.

Parental History of Premature Cardiovascular Disease, Estimated GFR, and Rate of Estimated GFR Decline: Results From the Aerobics Center Longitudinal Study

PubMed Central

Huang, Xiaoyan; Sui, Xuemei; Ruiz, Jonatan R.; Hirth, Victor; Ortega, Francisco B.; Blair, Steven N.; Carrero, Juan J.

2015-01-01

Background Despite cardiovascular disease (CVD) and chronic kidney disease (CKD) sharing similar etiologies and interplay, it remains unknown if a broader relationship between these diseases exists across generations. We investigated the association between parental CVD history and estimated glomerular filtration rate (eGFR) in the community. Study Design Cross-sectional and longitudinal analyses. Setting & Participants A total of 13,241 community-based adults with serum creatinine measurement and follow-up visits (from 1 to 8 visits, approximately 2 years apart) from the Aerobics Center Longitudinal Study. Predictors Premature parental CVD history (before age of 50 years). Outcomes eGFR, decreased eGFR (<60 mL/min/1.73m2), and rate of eGFR decline. Measurements Information of parental history was collected by protocol-standardized questionnaires. eGFR was assessed with serum creatinine. Results A total of 3,339 (25.2%) participants reported a history of parental CVD. Individuals with parental CVD had significantly lower eGFR compared with those without parental CVD (69.4 ± 12.9 vs. 74.8 ± 14.2 mL/min/1.73m2; P<0.001). After multivariable adjustment, parental CVD was independently associated with higher odds of having decreased eGFR (adjusted OR, 1.68; 95% CI, 1.52–1.86). Random-coefficient models showed that individuals with parental CVD had a faster decline in eGFR compared with those without parental CVD (sex- and ethnicity-adjusted annual change of −0.47 vs. −0.41 mL/min/1.73 m2; P=0.06). Limitations Approximately 70% of the participants did not attend a second examination. Conclusions Parental history of CVD was associated with lower baseline eGFR, higher odds of decreased eGFR, and a nominally faster rate of eGFR decline in the offspring. Such findings may imply previously unrecognized cross-generational links between both diseases and be of support in community screening programs. PMID:25600488

Computer classes and games in virtual reality environment to reduce loneliness among students of an elderly reference center: Study protocol for a randomised cross-over design.

PubMed

Antunes, Thaiany Pedrozo Campos; Oliveira, Acary Souza Bulle de; Crocetta, Tania Brusque; Antão, Jennifer Yohanna Ferreira de Lima; Barbosa, Renata Thais de Almeida; Guarnieri, Regiani; Massetti, Thais; Monteiro, Carlos Bandeira de Mello; Abreu, Luiz Carlos de

2017-03-01

Physical and mental changes associated with aging commonly lead to a decrease in communication capacity, reducing social interactions and increasing loneliness. Computer classes for older adults make significant contributions to social and cognitive aspects of aging. Games in a virtual reality (VR) environment stimulate the practice of communicative and cognitive skills and might also bring benefits to older adults. Furthermore, it might help to initiate their contact to the modern technology. The purpose of this study protocol is to evaluate the effects of practicing VR games during computer classes on the level of loneliness of students of an elderly reference center. This study will be a prospective longitudinal study with a randomised cross-over design, with subjects aged 50 years and older, of both genders, spontaneously enrolled in computer classes for beginners. Data collection will be done in 3 moments: moment 0 (T0) - at baseline; moment 1 (T1) - after 8 typical computer classes; and moment 2 (T2) - after 8 computer classes which include 15 minutes for practicing games in VR environment. A characterization questionnaire, the short version of the Short Social and Emotional Loneliness Scale for Adults (SELSA-S) and 3 games with VR (Random, MoviLetrando, and Reaction Time) will be used. For the intervention phase 4 other games will be used: Coincident Timing, Motor Skill Analyser, Labyrinth, and Fitts. The statistical analysis will compare the evolution in loneliness perception, performance, and reaction time during the practice of the games between the 3 moments of data collection. Performance and reaction time during the practice of the games will also be correlated to the loneliness perception. The protocol is approved by the host institution's ethics committee under the number 52305215.3.0000.0082. Results will be disseminated via peer-reviewed journal articles and conferences. This clinical trial is registered at ClinicalTrials.gov identifier: NCT02798081.

Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer

PubMed Central

Sundar, Sudha; Rick, Caroline; Dowling, Francis; Au, Pui; Rai, Nirmala; Champaneria, Rita; Stobart, Hilary; Neal, Richard; Davenport, Clare; Mallett, Susan; Sutton, Andrew; Kehoe, Sean; Timmerman, Dirk; Bourne, Tom; Van Calster, Ben; Gentry-Maharaj, Aleksandra; Deeks, Jon

2016-01-01

Introduction Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III). Methods and analysis ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios. PMID:27507231

The Marburg-Münster Affective Disorders Cohort Study (MACS): A quality assurance protocol for MR neuroimaging data.

PubMed

Vogelbacher, Christoph; Möbius, Thomas W D; Sommer, Jens; Schuster, Verena; Dannlowski, Udo; Kircher, Tilo; Dempfle, Astrid; Jansen, Andreas; Bopp, Miriam H A

2018-05-15

Large, longitudinal, multi-center MR neuroimaging studies require comprehensive quality assurance (QA) protocols for assessing the general quality of the compiled data, indicating potential malfunctions in the scanning equipment, and evaluating inter-site differences that need to be accounted for in subsequent analyses. We describe the implementation of a QA protocol for functional magnet resonance imaging (fMRI) data based on the regular measurement of an MRI phantom and an extensive variety of currently published QA statistics. The protocol is implemented in the MACS (Marburg-Münster Affective Disorders Cohort Study, http://for2107.de/), a two-center research consortium studying the neurobiological foundations of affective disorders. Between February 2015 and October 2016, 1214 phantom measurements have been acquired using a standard fMRI protocol. Using 444 healthy control subjects which have been measured between 2014 and 2016 in the cohort, we investigate the extent of between-site differences in contrast to the dependence on subject-specific covariates (age and sex) for structural MRI, fMRI, and diffusion tensor imaging (DTI) data. We show that most of the presented QA statistics differ severely not only between the two scanners used for the cohort but also between experimental settings (e.g. hardware and software changes), demonstrate that some of these statistics depend on external variables (e.g. time of day, temperature), highlight their strong dependence on proper handling of the MRI phantom, and show how the use of a phantom holder may balance this dependence. Site effects, however, do not only exist for the phantom data, but also for human MRI data. Using T1-weighted structural images, we show that total intracranial (TIV), grey matter (GMV), and white matter (WMV) volumes significantly differ between the MR scanners, showing large effect sizes. Voxel-based morphometry (VBM) analyses show that these structural differences observed between scanners are most pronounced in the bilateral basal ganglia, thalamus, and posterior regions. Using DTI data, we also show that fractional anisotropy (FA) differs between sites in almost all regions assessed. When pooling data from multiple centers, our data show that it is a necessity to account not only for inter-site differences but also for hardware and software changes of the scanning equipment. Also, the strong dependence of the QA statistics on the reliable placement of the MRI phantom shows that the use of a phantom holder is recommended to reduce the variance of the QA statistics and thus to increase the probability of detecting potential scanner malfunctions. Copyright © 2018 Elsevier Inc. All rights reserved.

Study protocol: Evaluating the impact of a rural Australian primary health care service on rural health

PubMed Central

2011-01-01

Background Rural communities throughout Australia are experiencing demographic ageing, increasing burden of chronic diseases, and de-population. Many are struggling to maintain viable health care services due to lack of infrastructure and workforce shortages. Hence, they face significant health disadvantages compared with urban regions. Primary health care yields the best health outcomes in situations characterised by limited resources. However, few rigorous longitudinal evaluations have been conducted to systematise them; assess their transferability; or assess sustainability amidst dynamic health policy environments. This paper describes the study protocol of a comprehensive longitudinal evaluation of a successful primary health care service in a small rural Australian community to assess its performance, sustainability, and responsiveness to changing community needs and health system requirements. Methods/Design The evaluation framework aims to examine the health service over a six-year period in terms of: (a) Structural domains (health service performance; sustainability; and quality of care); (b) Process domains (health service utilisation and satisfaction); and (c) Outcome domains (health behaviours, health outcomes and community viability). Significant international research guided the development of unambiguous reliable indicators for each domain that can be routinely and unobtrusively collected. Data are to be collected and analysed for trends from a range of sources: audits, community surveys, interviews and focus group discussions. Discussion This iterative evaluation framework and methodology aims to ensure the ongoing monitoring of service activity and health outcomes that allows researchers, providers and administrators to assess the extent to which health service objectives are met; the factors that helped or hindered achievements; what worked or did not work well and why; what aspects of the service could be improved and how; what benefits have been realised and for whom; the level of community satisfaction with the service; and the impact of a health service on community viability. While the need to reduce the rural-urban health service disparity in Australia is pressing, the evidence regarding how to move forward is inadequate. This comprehensive evaluation will add significant new knowledge regarding the characteristics associated with a sustainable rural primary health care service. PMID:21356123

Cohort Profile: The Social Environment and Biomarkers of Aging Study (SEBAS) in Taiwan

PubMed Central

Cornman, Jennifer C; Glei, Dana A; Goldman, Noreen; Chang, Ming-Cheng; Lin, Hui-Sheng; Chuang, Yi-Li; Hurng, Baai-Shyun; Lin, Yu-Hsuan; Lin, Shu-Hui; Liu, I-Wen; Liu, Hsia-Yuan; Weinstein, Maxine

2016-01-01

The Social Environment and Biomarkers of Aging Study (SEBAS) is a nationally representative longitudinal survey of Taiwanese middle-aged and older adults. It adds the collection of biomarkers and performance assessments to the Taiwan Longitudinal Study of Aging (TLSA), a nationally representative study of adults aged 60 and over, including the institutionalized population. The TLSA began in 1989, with follow-ups approximately every 3 years; younger refresher cohorts were added in 1996 and 2003. The first wave of SEBAS, based on a sub-sample of respondents from the 1999 TLSA, was conducted in 2000. A total of 1023 respondents completed both a face-to-face home interview and, several weeks later, a hospital-based physical examination. In addition to a 12-h (7 pm–7 am) urine specimen collected the night before and a fasting blood specimen collected during the examination, trained staff measured blood pressure, height, weight and waist and hip circumferences. A second wave of SEBAS was conducted in 2006 using a similar protocol to SEBAS 2000, but with the addition of performance assessments conducted by the interviewers at the end of the home interview. Both waves of SEBAS also included measures of health status (physical, emotional, cognitive), health behaviours, social relationships and exposure to stressors. The SEBAS data, which are publicly available at [http://www.icpsr.umich.edu/icpsrweb/NACDA/studies/3792/version/5], allow researchers to explore the relationships among life challenges, the social environment and health and to examine the antecedents, correlates and consequences of change in biological measures and health. PMID:25205853

Organ damage in sickle cell disease study (ORDISS): protocol for a longitudinal cohort study based in Ghana.

PubMed

Anie, Kofi A; Paintsil, Vivian; Owusu-Dabo, Ellis; Ansong, Daniel; Osei-Akoto, Alex; Ohene-Frempong, Kwaku; Amissah, Kofi Aikins; Addofoh, Nicholas; Ackah, Ezekiel Bonwin; Owusu-Ansah, Amma Twumwa; Ofori-Acquah, Solomon Fiifi

2017-08-28

Sickle cell disease is highly prevalent in Africa with a significant public health burden. Nonetheless, morbidity and mortality in sickle cell disease that result from the progression of organ damage is not well understood. The Organ Damage in Sickle Cell Disease Study (ORDISS) is designed as a longitudinal cohort study to provide critical insight into cellular and molecular pathogenesis of chronic organ damage for the development of future innovative treatment. ORDISS aims to recruit children aged 0-15 years who attend the Kumasi Centre for Sickle Cell Disease based at the Komfo Anokye Teaching Hospital in Kumasi, Ghana. Consent is obtained to collect blood and urine samples from the children during specified clinic visits and hospitalisations for acute events, to identify candidate and genetic markers of specific organ dysfunction and end-organ damage, over a 3 year period. In addition, data concerning clinical history and complications associated with sickle cell disease are collected. Samples are stored in biorepositories and analysed at the Kumasi Centre for Collaborative Research in Tropical Medicine, Ghana and the Centre for Translational and International Haematology, University of Pittsburgh, USA. Appropriate statistical analyses will be performed on the data acquired. Research ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals, and the key findings presented at national and international conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

3D culture of murine neural stem cells on decellularized mouse brain sections.

PubMed

De Waele, Jorrit; Reekmans, Kristien; Daans, Jasmijn; Goossens, Herman; Berneman, Zwi; Ponsaerts, Peter

2015-02-01

Transplantation of neural stem cells (NSC) in diseased or injured brain tissue is widely studied as a potential treatment for various neurological pathologies. However, effective cell replacement therapy relies on the intrinsic capacity of cellular grafts to overcome hypoxic and/or immunological barriers after transplantation. In this context, it is hypothesized that structural support for grafted NSC will be of utmost importance. With this study, we present a novel decellularization protocol for 1.5 mm thick mouse brain sections, resulting in the generation of acellular three-dimensional (3D) brain sections. Next, the obtained 3D brain sections were seeded with murine NSC expressing both the eGFP and luciferase reporter proteins (NSC-eGFP/Luc). Using real-time bioluminescence imaging, the survival and growth of seeded NSC-eGFP/Luc cells was longitudinally monitored for 1-7 weeks in culture, indicating the ability of the acellular brain sections to support sustained ex vivo growth of NSC. Next, the organization of a 3D maze-like cellular structure was examined using confocal microscopy. Moreover, under mitogenic stimuli (EGF and hFGF-2), most cells in this 3D culture retained their NSC phenotype. Concluding, we here present a novel protocol for decellularization of mouse brain sections, which subsequently support long-term 3D culture of undifferentiated NSC. Copyright © 2014 Elsevier Ltd. All rights reserved.

A process-based hierarchical framework for monitoring glaciated alpine headwaters

USGS Publications Warehouse

Weekes, Anne A.; Torgersen, Christian E.; Montgomery, David R.; Woodward, Andrea; Bolton, Susan M.

2012-01-01

Recent studies have demonstrated the geomorphic complexity and wide range of hydrologic regimes found in alpine headwater channels that provide complex habitats for aquatic taxa. These geohydrologic elements are fundamental to better understand patterns in species assemblages and indicator taxa and are necessary to aquatic monitoring protocols that aim to track changes in physical conditions. Complex physical variables shape many biological and ecological traits, including life history strategies, but these mechanisms can only be understood if critical physical variables are adequately represented within the sampling framework. To better align sampling design protocols with current geohydrologic knowledge, we present a conceptual framework that incorporates regional-scale conditions, basin-scale longitudinal profiles, valley-scale glacial macroform structure, valley segment-scale (i.e., colluvial, alluvial, and bedrock), and reach-scale channel types. At the valley segment- and reach-scales, these hierarchical levels are associated with differences in streamflow and sediment regime, water source contribution and water temperature. Examples of linked physical-ecological hypotheses placed in a landscape context and a case study using the proposed framework are presented to demonstrate the usefulness of this approach for monitoring complex temporal and spatial patterns and processes in glaciated basins. This approach is meant to aid in comparisons between mountain regions on a global scale and to improve management of potentially endangered alpine species affected by climate change and other stressors.

How socioeconomic inequalities impact pathways of care for coronary artery disease among elderly patients: study protocol for a qualitative longitudinal study.

PubMed

Schröder, Sara L; Fink, Astrid; Schumann, Nadine; Moor, Irene; Plehn, Alexander; Richter, Matthias

2015-11-09

Several studies have identified that socioeconomic inequalities in coronary artery disease (CAD) morbidity and mortality lead to a disadvantage in patients with low socioeconomic status (SES). International studies have shown that socioeconomic inequalities also exist in terms of access, utilisation and quality of cardiac care. The aim of this qualitative study is to provide information on the impact of socioeconomic inequalities on the pathway of care for CAD, and to establish which factors lead to socioeconomic inequality of care to form and expand existing scientific theories. A longitudinal qualitative study with 48 patients with CAD, aged 60-80 years, is being conducted. Patients have been recruited consecutively at the University Hospital in Halle/Saale, Germany, and will be followed for a period of 6 months. Patients are interviewed two times face-to-face using semistructured interviews. Data are transcribed and analysed based on grounded theory. Only participants who have been informed and who have signed a declaration of consent have been included in the study. The study complies rigorously with data protection legislation. Approval of the Ethical Review Committee at the Martin-Luther University Halle-Wittenberg, Germany was obtained. The results of the study will be presented at several congresses, and will be published in high-quality peer-reviewed international journals. This study has been registered with the German Clinical Trials Register and assigned DRKS00007839. 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/

An International Survey of Brain Banking Operation and Characterization Practices

PubMed Central

Palmer-Aronsten, Beatrix; McCrossin, Toni; Kril, Jillian

2016-01-01

Brain banks continue to make a major contribution to the study of neurological and psychiatric disorders. The current complexity and scope of research heighten the need for well-characterized cases and the demand for larger cohorts and necessitate strategies, such as the establishment of bank networks based in regional areas. While individual brain banks have developed protocols that meet researchers' needs within the confines of resources and funding, to further promote collaboration, standardization and scientific validity and understanding of the current protocols of participating banks are required. A survey was sent to brain banks, identified by an Internet search, to investigate operational protocols, case characterization, cohort management, data collection, standardization, and degree of collaboration between banks. The majority of the 24 banks that returned the survey have been established for more than 20 years, and most are affiliated with a regional network. While prospective donor programs were the primary source of donation, the data collected on donors varied. Longitudinal information assists case characterization and enhances the analysis capabilities of research. However, acquiring this information depended on the availability of qualified staff. Respondents indicated a high level of importance for standardization, but only 8 of 24 considered this occurred between banks. Standard diagnostic criteria were not achieved in the classification of controls, and some banks relied on the researcher to indicate the criteria for classification of controls. Although the capacity to collaborate with other banks was indicated by 16 of 24 banks, this occurred infrequently. Engagement of all brain banks to participate toward a consensus of diagnostic tools, especially for controls, will strengthen collaboration. PMID:27399803

An International Survey of Brain Banking Operation and Characterization Practices.

PubMed

Palmer-Aronsten, Beatrix; Sheedy, Donna; McCrossin, Toni; Kril, Jillian

2016-12-01

Brain banks continue to make a major contribution to the study of neurological and psychiatric disorders. The current complexity and scope of research heighten the need for well-characterized cases and the demand for larger cohorts and necessitate strategies, such as the establishment of bank networks based in regional areas. While individual brain banks have developed protocols that meet researchers' needs within the confines of resources and funding, to further promote collaboration, standardization and scientific validity and understanding of the current protocols of participating banks are required. A survey was sent to brain banks, identified by an Internet search, to investigate operational protocols, case characterization, cohort management, data collection, standardization, and degree of collaboration between banks. The majority of the 24 banks that returned the survey have been established for more than 20 years, and most are affiliated with a regional network. While prospective donor programs were the primary source of donation, the data collected on donors varied. Longitudinal information assists case characterization and enhances the analysis capabilities of research. However, acquiring this information depended on the availability of qualified staff. Respondents indicated a high level of importance for standardization, but only 8 of 24 considered this occurred between banks. Standard diagnostic criteria were not achieved in the classification of controls, and some banks relied on the researcher to indicate the criteria for classification of controls. Although the capacity to collaborate with other banks was indicated by 16 of 24 banks, this occurred infrequently. Engagement of all brain banks to participate toward a consensus of diagnostic tools, especially for controls, will strengthen collaboration.

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial.

PubMed

Pastor, María-Ángeles; López-Roig, Sofía; Lledó, Ana; Peñacoba, Cecilia; Velasco, Lilian; Schweiger-Gallo, Inge; Cigarán, Margarita; Ecija, Carmen; Limón, Ramón; Sanz, Yolanda

2014-04-11

Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients' associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients' associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. The first data gathered have allowed us to identify the characteristics of the study population and they support the appropriateness of the inclusion criteria.. When the study is complete, the results will enable us to establish whether this kind of intervention can be used as a self-regulation tool for increasing and maintaining walking as unsupervised physical exercise of low to moderate intensity in fibromyalgia patients. ISRCTN68584893.

Protocol for a prospective longitudinal study investigating the participation and educational trajectories of Australian students with autism

PubMed Central

Roberts, Jacqueline Margaret Anne; Adams, Dawn; Heussler, Helen; Keen, Deborah; Paynter, Jessica; Trembath, David; Westerveld, Marleen; Williams, Katrina

2018-01-01

Introduction Autism is associated with high cost to individuals, families, communities and government. Understanding educational and participation trajectories during the school years, and factors influencing these, is fundamental to reducing financial and personal costs. The primary aim of this study is to document the trajectories of Australian students with autism during their education. The secondary aim is to examine personal (eg, student skills) and environmental (eg, school setting) factors associated with differing trajectories and outcomes. Methods and analysis The cross-sequential longitudinal study will recruit two cohorts of 120 parents/caregivers of children with autism. Cohort 1 aged between 4 and 5 years and cohort 2 between 9 and 10 years to start the study. Information will be gathered from parents, teachers and school principals at six annual time points (T1 to T6). Parents will be emailed a link to an online initial questionnaire (T1) and then contacted annually and asked to complete either an extended questionnaire (T3, T5 and T6) or an abbreviated questionnaire (T2, T4). Where consent is given, the child’s current school will be contacted annually (T1 to T6) and teacher and school principal asked to complete questionnaires about the child and school. Parent and school questionnaires are comprised of questions about demographic and school factors that could influence trajectories and a battery of developmental and behavioural assessment tools designed to assess educational and participation trajectories and outcomes. Surveys will provide longitudinal data on educational and participation trajectories for children and adolescents with autism. In addition cross-sectional comparisons (within or between age groups) at each time point and cohort effects will be explored. Ethics and dissemination Ethics approvals have been granted for this study by all recruiting sites and universities in the project. Study findings will inform policy and practice to promote successful inclusion and participation of children with autism in education. Results will be disseminated through journal publication, conference and seminar presentation. PMID:29362247

A Preliminary Study of the Effects of a Multitheory-Driven Intervention in Adults With Prediabetes Mellitus.

PubMed

Tsai, Fu-Mian; Lin, Chiu-Chu; Lin, Huey-Shyan; Liu, Yi

2018-06-01

Prediabetes mellitus (pre-DM) is an important predictive indicator of Type 2 diabetes. A person with pre-DM is eight times more likely to develop diabetes than a person without pre-DM. Prior research suggests that proactive interventions may delay the progression of this disease and reduce the rate of disease development. The purposes of this preliminary study were to develop a multitheory-driven lifestyle intervention protocol for adults with pre-DM and to evaluate its feasibility and impacts on knowledge regarding pre-DM, dietary behaviors, and physical activity (primary outcomes) as well as to describe the disease progression indicators (secondary outcomes). A single-group, longitudinal study design was used. Thirty-nine participants were included in the analysis. A generalized estimating equation model was used to determine the trends in changes in the outcomes. All of the participants underwent testing at baseline (T0) and at 3 (T1), 6 (T2), and 12 (T3) months after the 4-week lifestyle intervention. There were significantly increasing trends for each study parameter (Pre-DM Knowledge Assessment Form-12, p < .01; Dietary Behavior Scale, p < .01) and significantly positive changes in body weight (p < .01), body mass index (p < .01), fasting glucose level (p < .01), and glycated hemoglobin level (p < .01) over the 12-month study period. This study supports the feasibility of the developed multitheory-driven lifestyle intervention protocol and suggests that its application may improve the effectiveness of diabetes prevention programs in clinical settings. Further randomized controlled trials are needed.

Development of a hospital-based patient-reported outcome framework for lung cancer patients: a study protocol.

PubMed

Moloczij, Natasha; Gough, Karla; Solomon, Benjamin; Ball, David; Mileshkin, Linda; Duffy, Mary; Krishnasamy, Mei

2018-01-11

Patient-reported outcome (PRO) data is central to the delivery of quality health care. Establishing sustainable, reliable and cost-efficient methods for routine collection and integration of PRO data into health information systems is challenging. This protocol paper describes the design and structure of a study to develop and pilot test a PRO framework to systematically and longitudinally collect PRO data from a cohort of lung cancer patients at a comprehensive cancer centre in Australia. Best-practice guidelines for developing registries aimed at collecting PROs informed the development of this PRO framework. Framework components included: achieving consensus on determining the purpose of the framework, the PRO measures to be included, the data collection time points and collection methods (electronic and paper), establishing processes to safeguard the quality of the data collected and to link the PRO framework to an existing hospital-based lung cancer clinical registry. Lung cancer patients will be invited to give feedback on the PRO measures (PROMs) chosen and the data collection time points and methods. Implementation of the framework will be piloted for 12 months. Then a mixed-methods approach used to explore patient and multidisciplinary perspectives on the feasibility of implementing the framework and linking it to the lung cancer clinical registry, its clinical utility, perceptions of data collection burden, and preliminary assessment of resource costs to integrate, implement and sustain the PRO framework. The PRO data set will include: a quality of life questionnaire (EORTC-QLQ-C30) and the EORTC lung cancer specific module (QLQC-LC-13). These will be collected pre-treatment (baseline), 2, 6 and 12 months post-baseline. Also, four social isolation questions (PROMIS) will be collected at baseline. Identifying and deciding on the overall purpose, clinical utility of data and which PROs to collect from patients requires careful consideration. Our study will explore how PRO data collection processes that link to a clinical data set can be developed and integrated; how PRO systems that are easy for patients to complete and professionals to use in practice can be achieved, and will provide indicative costs of developing and integrating a longitudinal PRO framework into routine hospital data collection systems. This study is not a clinical trial and is therefore not registered in any trial registry. However, it has received human research ethics approval (LNR/16/PMCC/45).

The "Medicine in Australia: Balancing Employment and Life (MABEL)" longitudinal survey - Protocol and baseline data for a prospective cohort study of Australian doctors' workforce participation

PubMed Central

2010-01-01

Background While there is considerable research on medical workforce supply trends, there is little research examining the determinants of labour supply decisions for the medical workforce. The "Medicine in Australia: Balancing Employment and Life (MABEL)" study investigates workforce participation patterns and their determinants using a longitudinal survey of Australian doctors. It aims to generate evidence to support developing effective policy responses to workforce issues such as shortages and maldistribution. This paper describes the study protocol and baseline cohort, including an analysis of response rates and response bias. Methods/Design MABEL is a prospective cohort study. All Australian doctors undertaking clinical work in 2008 (n = 54,750) were invited to participate, and annual waves of data collections will be undertaken until at least 2011. Data are collected by paper or optional online version of a questionnaire, with content tailored to four sub-groups of clinicians: general practitioners, specialists, specialists in training, and hospital non-specialists. In the baseline wave, data were collected on: job satisfaction, attitudes to work and intentions to quit or change hours worked; a discrete choice experiment examining preferences and trade-offs for different types of jobs; work setting; workload; finances; geographic location; demographics; and family circumstances. Discussion The baseline cohort includes 10,498 Australian doctors, representing an overall response rate of 19.36%. This includes 3,906 general practitioners, 4,596 specialists, 1,072 specialists in training, and 924 hospital non-specialists. Respondents were more likely to be younger, female, and to come from non-metropolitan areas, the latter partly reflecting the effect of a financial incentive on response for doctors in remote and rural areas. Specialists and specialists in training were more likely to respond, whilst hospital non-specialists were less likely to respond. The distribution of hours worked was similar between respondents and data from national medical labour force statistics. The MABEL survey provides a large, representative cohort of Australian doctors. It enables investigation of the determinants of doctors' decisions about how much, where and in what circumstances they practice, and of changes in these over time. MABEL is intended to provide an important resource for policy makers and other stakeholders in the Australian medical workforce. PMID:20181288

Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study: a protocol for a prospective, longitudinal cohort study

PubMed Central

Liu, Bin; Xu, Yun; Zhang, Ying; Cai, Jian; Deng, Langhui; Yang, Jianbo; Zhou, Yi; Long, Yuhang; Zhang, Jinxin; Wang, Zilian

2016-01-01

Introduction A diagnosis of gestational diabetes mellitus (GDM) in low-risk pregnant women is based on an oral glucose tolerance test (OGTT) between 24 and 28 gestational weeks. However, there is insufficient evidence for why the test is performed in this time period. Moreover, the fetus may be exposed to hyperglycaemia prior to the current testing time frame, making earlier administration potentially advantageous. The main purpose of the present study is to investigate the GDM diagnostic value of an OGTT performed at 18–20 gestational weeks. The results of the study may provide scientific insight into the most beneficial time of OGTT for pregnant women. Methods and analysis As a prospective, longitudinal cohort study, the Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study will recruit 570 pregnant women who meet the inclusion and exclusion criteria outlined below. OGTTs will be performed between 18 and 20 gestational weeks (early OGTT) and 24–28 gestational weeks (regular OGTT). Clinical and laboratory information of the mother and their offspring will be collected for analysis. The prevalence of GDM at 18–20 gestational weeks will be described, and the sensitivity, specificity, positive predictive value and negative predictive value of early OGTT on diagnosis of GDM will be studied. Clinical outcomes associated with hyperglycaemia will be compared between groups diagnosed by early or regular OGTT. Ethics and dissemination The study was approved by The Ethical Committees of The First Affiliated Hospital of Sun Yat-sen University (number 2016-042). Signed informed consent will be obtained from all participants. The results of this study will be disseminated in peer-reviewed journals. Trial registration number NCT02740283. PMID:27872115

Characterization of Postinfusion Phenotypic Differences in Fresh Versus Cryopreserved TCR Engineered Adoptive Cell Therapy Products.

PubMed

Nowicki, Theodore S; Escuin-Ordinas, Helena; Avramis, Earl; Chmielowski, Bartosz; Chodon, Thinle; Berent-Maoz, Beata; Wang, Xiaoyan; Kaplan-Lefko, Paula; Yang, Lili; Baltimore, David; Economou, James S; Ribas, Antoni; Comin-Anduix, Begoña

2018-06-01

Adoptive cell therapy (ACT) consisting of genetically engineered T cells expressing tumor antigen-specific T-cell receptors displays robust initial antitumor activity, followed by loss of T-cell activity/persistence and frequent disease relapse. We characterized baseline and longitudinal T-cell phenotype variations resulting from different manufacturing and administration protocols in patients who received ACT. Patients with melanoma who enrolled in the F5-MART-1 clinical trial (NCT00910650) received infusions of MART-1 T-cell receptors transgenic T cells with MART-1 peptide-pulsed dendritic cell vaccination. Patients were divided into cohorts based on several manufacturing changes in the generation and administration of the transgenic T cells: decreasing ex vivo stimulation/expansion time, increased cell dose, and receiving fresh instead of cryopreserved cells. T-cell phenotypes were analyzed by flow cytometry at baseline and longitudinally in peripheral blood. Transgenic T cells with shorter ex vivo culture/expansion periods displayed significantly increased expression of markers associated with less differentiated naive/memory populations, as well as significantly decreased expression of the inhibitory receptor programmed death 1 (PD1). Patients receiving fresh infusions of transgenic cells demonstrated expansion of central memory T cells and delayed acquisition of PD1 expression compared with patients who received cryopreserved products. Freshly infused transgenic T cells showed persistence and expansion of naive and memory T-cell populations and delayed acquisition of PD1 expression, which correlated with this cohort's superior persistence of transgenic cells and response to dendritic cell vaccines. These results may be useful in designing future ACT protocols.

Characterization of Postinfusion Phenotypic Differences in Fresh Versus Cryopreserved TCR Engineered Adoptive Cell Therapy Products

PubMed Central

Nowicki, Theodore S.; Escuin-Ordinas, Helena; Avramis, Earl; Chmielowski, Bartosz; Chodon, Thinle; Berent-Maoz, Beata; Wang, Xiaoyan; Kaplan-Lefko, Paula; Yang, Lili; Baltimore, David; Economou, James S.; Ribas, Antoni

2018-01-01

Adoptive cell therapy (ACT) consisting of genetically engineered T cells expressing tumor antigen-specific T-cell receptors displays robust initial antitumor activity, followed by loss of T-cell activity/persistence and frequent disease relapse. We characterized baseline and longitudinal T-cell phenotype variations resulting from different manufacturing and administration protocols in patients who received ACT. Patients with melanoma who enrolled in the F5-MART-1 clinical trial (NCT00910650) received infusions of MART-1 T-cell receptors transgenic T cells with MART-1 peptide-pulsed dendritic cell vaccination. Patients were divided into cohorts based on several manufacturing changes in the generation and administration of the transgenic T cells: decreasing ex vivo stimulation/expansion time, increased cell dose, and receiving fresh instead of cryopreserved cells. T-cell phenotypes were analyzed by flow cytometry at baseline and longitudinally in peripheral blood. Transgenic T cells with shorter ex vivo culture/expansion periods displayed significantly increased expression of markers associated with less differentiated naive/memory populations, as well as significantly decreased expression of the inhibitory receptor programmed death 1 (PD1). Patients receiving fresh infusions of transgenic cells demonstrated expansion of central memory T cells and delayed acquisition of PD1 expression compared with patients who received cryopreserved products. Freshly infused transgenic T cells showed persistence and expansion of naive and memory T-cell populations and delayed acquisition of PD1 expression, which correlated with this cohort’s superior persistence of transgenic cells and response to dendritic cell vaccines. These results may be useful in designing future ACT protocols. PMID:29470191

Quantitative MRI Establishes the Efficacy of PI3K Inhibitor (GDC-0941) Multi-Treatments in PTEN-deficient Mice Lymphoma

PubMed Central

WULLSCHLEGER, STEPHAN; GARCÍA-MARTÍNEZ, JUAN M.; DUCE, SUZANNE L.

2012-01-01

Aim To assess the efficacy of multiple treatment of phosphatidylinositol-3-kinase (PI3K) inhibitor on autochthonous tumours in phosphatase and tensin homologue (Pten)-deficient genetically engineered mouse cancer models using a longitudinal magnetic resonance imaging (MRI) protocol. Materials and Methods Using 3D MRI, B-cell follicular lymphoma growth was quantified in a Pten+/−Lkb1+/hypo mouse line, before, during and after repeated treatments with a PI3K inhibitor GDC-0941 (75 mg/kg). Results Mean pre-treatment linear tumour growth rate was 16.5±12.8 mm3/week. Repeated 28-day GDC-0941 administration, with 21 days “off-treatment”, induced average tumour regression of 41±7%. Upon cessation of the second treatment (which was not permanently cytocidal), tumours re-grew with an average linear growth rate of 40.1±15.5 mm3/week. There was no evidence of chemoresistance. Conclusion This protocol can accommodate complex dosing schedules, as well as combine different cancer therapies. It reduces biological variability problems and resulted in a 10-fold reduction in mouse numbers compared with terminal assessment methods. It is ideal for preclinical efficacy studies and for phenotyping molecularly characterized mouse models when investigating gene function. PMID:22287727

Six-color intravital two-photon imaging of brain tumors and their dynamic microenvironment.

PubMed

Ricard, Clément; Debarbieux, Franck Christian

2014-01-01

The majority of intravital studies on brain tumor in living animal so far rely on dual color imaging. We describe here a multiphoton imaging protocol to dynamically characterize the interactions between six cellular components in a living mouse. We applied this methodology to a clinically relevant glioblastoma multiforme (GBM) model designed in reporter mice with targeted cell populations labeled by fluorescent proteins of different colors. This model permitted us to make non-invasive longitudinal and multi-scale observations of cell-to-cell interactions. We provide examples of such 5D (x,y,z,t,color) images acquired on a daily basis from volumes of interest, covering most of the mouse parietal cortex at subcellular resolution. Spectral deconvolution allowed us to accurately separate each cell population as well as some components of the extracellular matrix. The technique represents a powerful tool for investigating how tumor progression is influenced by the interactions of tumor cells with host cells and the extracellular matrix micro-environment. It will be especially valuable for evaluating neuro-oncological drug efficacy and target specificity. The imaging protocol provided here can be easily translated to other mouse models of neuropathologies, and should also be of fundamental interest for investigations in other areas of systems biology.

Differentiating gold nanorod samples using particle size and shape distributions from transmission electron microscope images

NASA Astrophysics Data System (ADS)

Grulke, Eric A.; Wu, Xiaochun; Ji, Yinglu; Buhr, Egbert; Yamamoto, Kazuhiro; Song, Nam Woong; Stefaniak, Aleksandr B.; Schwegler-Berry, Diane; Burchett, Woodrow W.; Lambert, Joshua; Stromberg, Arnold J.

2018-04-01

Size and shape distributions of gold nanorod samples are critical to their physico-chemical properties, especially their longitudinal surface plasmon resonance. This interlaboratory comparison study developed methods for measuring and evaluating size and shape distributions for gold nanorod samples using transmission electron microscopy (TEM) images. The objective was to determine whether two different samples, which had different performance attributes in their application, were different with respect to their size and/or shape descriptor distributions. Touching particles in the captured images were identified using a ruggedness shape descriptor. Nanorods could be distinguished from nanocubes using an elongational shape descriptor. A non-parametric statistical test showed that cumulative distributions of an elongational shape descriptor, that is, the aspect ratio, were statistically different between the two samples for all laboratories. While the scale parameters of size and shape distributions were similar for both samples, the width parameters of size and shape distributions were statistically different. This protocol fulfills an important need for a standardized approach to measure gold nanorod size and shape distributions for applications in which quantitative measurements and comparisons are important. Furthermore, the validated protocol workflow can be automated, thus providing consistent and rapid measurements of nanorod size and shape distributions for researchers, regulatory agencies, and industry.

Dual tracer imaging of SPECT and PET probes in living mice using a sequential protocol

PubMed Central

Chapman, Sarah E; Diener, Justin M; Sasser, Todd A; Correcher, Carlos; González, Antonio J; Avermaete, Tony Van; Leevy, W Matthew

2012-01-01

Over the past 20 years, multimodal imaging strategies have motivated the fusion of Positron Emission Tomography (PET) or Single Photon Emission Computed Tomography (SPECT) scans with an X-ray computed tomography (CT) image to provide anatomical information, as well as a framework with which molecular and functional images may be co-registered. Recently, pre-clinical nuclear imaging technology has evolved to capture multiple SPECT or multiple PET tracers to further enhance the information content gathered within an imaging experiment. However, the use of SPECT and PET probes together, in the same animal, has remained a challenge. Here we describe a straightforward method using an integrated trimodal imaging system and a sequential dosing/acquisition protocol to achieve dual tracer imaging with 99mTc and 18F isotopes, along with anatomical CT, on an individual specimen. Dosing and imaging is completed so that minimal animal manipulations are required, full trimodal fusion is conserved, and tracer crosstalk including down-scatter of the PET tracer in SPECT mode is avoided. This technique will enhance the ability of preclinical researchers to detect multiple disease targets and perform functional, molecular, and anatomical imaging on individual specimens to increase the information content gathered within longitudinal in vivo studies. PMID:23145357

What you need to know about ossification of the posterior longitudinal ligament to optimize cervical spine surgery: A review

PubMed Central

Epstein, Nancy E.

2014-01-01

What are the risks, benefits, alternatives, and pitfalls for operating on cervical ossification of the posterior longitudinal ligament (OPLL)? To successfully diagnose OPLL, it is important to obtain Magnetic Resonance Images (MR). These studies, particularly the T2 weighted images, provide the best soft-tissue documentation of cord/root compression and intrinsic cord abnormalities (e.g. edema vs. myelomalacia) on sagittal, axial, and coronal views. Obtaining Computed Tomographic (CT) scans is also critical as they best demonstrate early OPLL, or hypertrophied posterior longitudinal ligament (HPLL: hypo-isodense with punctate ossification) or classic (frankly ossified) OPLL (hyperdense). Furthermore, CT scans reveal the “single layer” and “double layer” signs indicative of OPLL penetrating the dura. Documenting the full extent of OPLL with both MR and CT dictates whether anterior, posterior, or circumferential surgery is warranted. An adequate cervical lordosis allows for posterior cervical approaches (e.g. lamionplasty, laminectomy/fusion), which may facilitate addressing multiple levels while avoiding the risks of anterior procedures. However, without lordosis and with significant kyphosis, anterior surgery may be indicated. Rarely, this requires single/multilevel anterior cervical diskectomy/fusion (ACDF), as this approach typically fails to address retrovertebral OPLL; single or multilevel corpectomies are usually warranted. In short, successful OPLL surgery relies on careful patient selection (e.g. assess comorbidities), accurate MR/CT documentation of OPLL, and limiting the pros, cons, and complications of these complex procedures by choosing the optimal surgical approach. Performing OPLL surgery requires stringent anesthetic (awake intubation/positioning) and also the following intraoperative monitoring protocols: Somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), and electromyography (EMG). PMID:24843819

Longitudinal testing of hippocampal plasticity reveals the onset and maintenance of endogenous human Aß-induced synaptic dysfunction in individual freely behaving pre-plaque transgenic rats: rapid reversal by anti-Aß agents.

PubMed

Qi, Yingjie; Klyubin, Igor; Harney, Sarah C; Hu, NengWei; Cullen, William K; Grant, Marianne K; Steffen, Julia; Wilson, Edward N; Do Carmo, Sonia; Remy, Stefan; Fuhrmann, Martin; Ashe, Karen H; Cuello, A Claudio; Rowan, Michael J

2014-12-24

Long before synaptic loss occurs in Alzheimer's disease significant harbingers of disease may be detected at the functional level. Here we examined if synaptic long-term potentiation is selectively disrupted prior to extracellular deposition of Aß in a very complete model of Alzheimer's disease amyloidosis, the McGill-R-Thy1-APP transgenic rat. Longitudinal studies in freely behaving animals revealed an age-dependent, relatively rapid-onset and persistent inhibition of long-term potentiation without a change in baseline synaptic transmission in the CA1 area of the hippocampus. Thus the ability of a standard 200 Hz conditioning protocol to induce significant NMDA receptor-dependent short- and long-term potentiation was lost at about 3.5 months of age and this deficit persisted for at least another 2-3 months, when plaques start to appear. Consistent with in vitro evidence for a causal role of a selective reduction in NMDA receptor-mediated synaptic currents, the deficit in synaptic plasticity in vivo was associated with a reduction in the synaptic burst response to the conditioning stimulation and was overcome using stronger 400 Hz stimulation. Moreover, intracerebroventricular treatment for 3 days with an N-terminally directed monoclonal anti- human Aß antibody, McSA1, transiently reversed the impairment of synaptic plasticity. Similar brief treatment with the BACE1 inhibitor LY2886721 or the γ-secretase inhibitor MRK-560 was found to have a comparable short-lived ameliorative effect when tracked in individual rats. These findings provide strong evidence that endogenously generated human Aß selectively disrupts the induction of long-term potentiation in a manner that enables potential therapeutic options to be assessed longitudinally at the pre-plaque stage of Alzheimer's disease amyloidosis.

MRI allows for longitudinal quantitative analysis of body fat composition in rats: an analysis of sibutramine-associated changes at the group level.

PubMed

Müller, Hans-Peter; Niessen, Heiko G; Kaulisch, Thomas; Ludolph, Albert C; Kassubek, Jan; Stiller, Detlef

2013-09-01

Body fat distribution changes are associated with multiple alterations in metabolism. Therefore, the assessment of body fat compartments by MRI in animal models is a promising approach to obesity research. Standard T1-weighted (T1w) whole body MRI was used here to quantify different effects in the subcutaneous and visceral fat compartments in rats under treatment with an anorexiant. Twenty rats on a high caloric diet were investigated by the identical MRI protocol at baseline and after seven weeks. Ten rats received a treatment with sibutramine, 10 rats served as vehicle control group. To longitudinally assess body fat components, MRI analysis was used with two approaches: 2D slicewise graphic analysis (SGA) was compared with an automated 3D analysis algorithm (3DA). At the group level, fat volume differences showed a longitudinal increase of subcutaneous and visceral fat volumes for the control group, whereas the sibutramine group showed stable subcutaneous fat volumes and decrease in visceral fat volumes. SGA and 3DA volume determination showed significant correlations for subcutaneous fat volume (C=0.85, p<0.001), visceral fat volume (C=0.87, p<0.001), and total fat volume (C=0.90, p<0.001). It could be demonstrated that computer-based analysis of T1w MRI could be used to longitudinally assess changes in body fat compartments in rats at the group level. In detail, it was possible to investigate the effect of sibutramine separate on the fat compartments in rats. Copyright © 2013 Elsevier Inc. All rights reserved.

Influence of Exercise and Training on Critical Stages of Bone Growth and Development.

PubMed

Klentrou, Panagiota

2016-05-01

Although osteoporosis is considered a geriatric disease, factors affecting bone strength are most influential during child growth and development. This article reviews what is known and still unclear in terms of bone growth, development and adaptation relative to physical activity before and during puberty. Bone is responsive to certain exercise protocols early in puberty and less so in postpubertal years, where bone strength, rather than bone mass, being the outcome of interest. Mechanical loading and high impact exercise promote bone strength. Intense training before and during puberty, however, may negatively affect bone development. Future research should focus on increasing our mechanistic understanding of the manner by which diverse physical stressors alter the integrity of bone. Longitudinal studies that examine the extent to which muscle and bone are comodulated by growth in children are also recommended.

Early nutrition, growth and cognitive development of infants from birth to 2 years in Malaysia: a study protocol.

PubMed

Nurliyana, Abdul Razak; Mohd Shariff, Zalilah; Mohd Taib, Mohd Nasir; Gan, Wan Ying; Tan, Kit-Aun

2016-09-29

The first 2 years of life is a critical period of rapid growth and brain development. During this period, nutrition and environmental factors play important roles in growth and cognitive development of a child. This report describes the study protocol of early nutrition, growth and cognitive development of infants from birth to 2 years of age. This is a prospective cohort study of mothers and infants recruited from government health clinics in Seremban district in Negeri Sembilan, Malaysia. Infants are followed-up at 6, 12, 18 and 24 months of age. Pre-natal factors that include mother's pre-pregnancy body mass index, gestational weight gain, blood glucose and blood pressure during pregnancy, infant's gestational age, birth weight and head circumference at birth are obtained from patient card. Post-natal factors assessed at each follow-up are feeding practices, dietary intake, anthropometric measurements and cognitive development of infants. Iron status is assessed at 6 months, while infant temperament and home environment are assessed at 12 months. Maternal intelligence is assessed at 18 months. Early life nutritional programming is of current interest as many longitudinal studies are actively being conducted in developed countries to investigate this concept. The concept however is relatively new in developing countries such as Malaysia. This study will provide useful information on early nutrition and infant development in the first two years of life which can be further followed up to identify factors that track into childhood and contribute to growth and cognitive deviations.

Further investigation of phenotypes and confounding factors of progressive ratio performance and feeding behavior in the BACHD rat model of Huntington disease.

PubMed

Clemensson, Erik Karl Håkan; Clemensson, Laura Emily; Fabry, Benedikt; Riess, Olaf; Nguyen, Huu Phuc

2017-01-01

Huntington disease is an inherited neurodegenerative disorder characterized by motor, cognitive, psychiatric and metabolic symptoms. We recently published a study describing that the BACHD rat model of HD shows an obesity phenotype, which might affect their motivation to perform food-based behavioral tests. Further, we argued that using a food restriction protocol based on matching BACHD and wild type rats' food consumption rates might resolve these motivational differences. In the current study, we followed up on these ideas in a longitudinal study of the rats' performance in a progressive ratio test. We also investigated the phenotype of reduced food consumption rate, which is typically seen in food-restricted BACHD rats, in greater detail. In line with our previous study, the BACHD rats were less motivated to perform the progressive ratio test compared to their wild type littermates, although the phenotype was no longer present when the rats' food consumption rates had been matched. However, video analysis of food consumption tests suggested that the reduced consumption rate found in the BACHD rats was not entirely based on differences in hunger, but likely involved motoric impairments. Thus, restriction protocols based on food consumption rates are not appropriate when working with BACHD rats. As an alternative, we suggest that studies where BACHD rats are used should investigate how the readouts of interest are affected by motivational differences, and use appropriate control tests to avoid misleading results. In addition, we show that BACHD rats display distinct behavioral changes in their progressive ratio performance, which might be indicative of striatal dysfunction.

Prevalence of hypertrophic cardiomyopathy on an electrocardiogram-based pre-participation screening programme in a young male South-East Asian population: results from the Singapore Armed Forces Electrocardiogram and Echocardiogram screening protocol.

PubMed

Ng, Choon Ta; Chee, Tek Siong; Ling, Lee Fong; Lee, Yian Ping; Ching, Chi Keong; Chua, Terrance S J; Cheok, Christopher; Ong, Hean Yee

2011-06-01

Hypertrophic cardiomyopathy is a leading cause of sudden cardiac death (SCD) in young people in the USA. Pre-participation screening for athletes might reduce the incidence of SCD. In Singapore, military service is compulsory for all young able-bodied male citizens. The Singapore Armed Forces Electrocardiogram and Echocardiogram (SAFE) pre-participation screening protocol based on the Italian programme was introduced. This study evaluates the prevalence of hypertrophic cardiomyopathy (HCM) in a young male South-East Asian population. From October 2008 to May 2009, all male military conscripts underwent pre-participation screening. For all conscripts whose electrocardiogram (ECG) findings fulfilled any of these pre-specified criteria (Group A), direct referral for a transthoracic echocardiogram was mandatory. Conscripts with ECG findings other than pre-specified criteria (e.g. T-wave inversions, repolarization abnormalities) were referred for secondary screening by cardiologists (Group B), which could include echocardiography. Out of 18 476 subjects screened during the study period, 988 (5.3%) subjects were fast tracked for echocardiogram (Group A). Of them, there were three (0.3%) cases with severe abnormalities; there was one case each of HCM, bicuspid aortic valve with significant aortic valve regurgitation, and atrial septal defect with right ventricular systolic dysfunction. The patient with HCM had left axis deviation on ECG. None of the 215 patients who underwent echocardiography following cardiology consult (Group B) had HCM. The prevalence of HCM in our young male population (mean age 19.5, range 16-27) using an ECG-based screening protocol was 0.005%; this appeared lower than published data from other geographical cohorts. Possible explanations include a later age of phenotypic manifestation in our population, limitations of the ECG criteria for screening, or a truly lower prevalence of HCM. More population-based longitudinal studies would be needed to ascertain the true prevalence of HCM in our South-East Asian population.

The Maternal Adversity, Vulnerability and Neurodevelopment Project: Theory and Methodology

PubMed Central

O’Donnell, Katherine A; Gaudreau, Hélène; Colalillo, Sara; Steiner, Meir; Atkinson, Leslie; Moss, Ellen; Goldberg, Susan; Karama, Sherif; Matthews, Stephen G; Lydon, John E; Silveira, Patricia P; Wazana, Ashley D; Levitan, Robert D; Sokolowski, Marla B; Kennedy, James L; Fleming, Alison; Meaney, Michael J

2014-01-01

Objective: To describe the theory and methodology of the multi-wave, prospective Maternal Adversity, Vulnerability and Neurodevelopment (MAVAN) study. The goal of MAVAN is to examine the pre- and postnatal influences, and their interaction, in determining individual differences in mental health. Method: MAVAN is a community-based, birth cohort study of pregnant Canadian mothers and their offspring. Dyads are assessed longitudinally, with multiple assessments of both mother and child in home and laboratory across the child’s development. Study measures, including assessments of cognitive and emotional function, are described. The study uses a candidate gene approach to examine gene–environment interdependence in specific developmental outcomes. Finally, the study includes measures of both brain-based phenotypes and metabolism to explore comorbidities associated with child obesity. One of the unique features of the MAVAN protocol is the extensive measures of the mother–child interaction. The relation between these measures will be discussed. Results: Evidence from the MAVAN project shows interesting results about maternal care, families, and child outcomes. In our review, preliminary analyses showing the correlations between measures of maternal care are reported. As predicted, early evidence suggests that maternal care measures are positively correlated, over time. Conclusions: This review provides evidence for the feasibility and value of laboratory-based measures embedded within a longitudinal birth cohort study. Though retention of the samples has been a challenge of MAVAN, they are within a comparable range to other studies of this nature. Indeed, the trade-off of somewhat greater participant burden has allowed for a rich database. The results yielded from the MAVAN project will not only describe typical development but also possible targets for intervention. Understanding certain endophenotypes will shed light on the pathogenesis of various mental and physical disorders, as well as their interrelation. PMID:25565695

Examining unanswered questions about the home environment and childhood obesity disparities using an incremental, mixed-methods, longitudinal study design: The Family Matters study.

PubMed

Berge, Jerica M; Trofholz, Amanda; Tate, Allan D; Beebe, Maureen; Fertig, Angela; Miner, Michael H; Crow, Scott; Culhane-Pera, Kathleen A; Pergament, Shannon; Neumark-Sztainer, Dianne

2017-11-01

There are disparities in the prevalence of childhood obesity for children from low-income and minority households. Mixed-methods studies that examine home environments in an in-depth manner are needed to identify potential mechanisms driving childhood obesity disparities that have not been examined in prior research. The Family Matters study aims to identify risk and protective factors for childhood obesity in low-income and minority households through a two-phased incremental, mixed-methods, and longitudinal approach. Individual, dyadic (i.e., parent/child; siblings), and familial factors that are associated with, or moderate associations with childhood obesity will be examined. Phase I includes in-home observations of diverse families (n=150; 25 each of African American, American Indian, Hispanic/Latino, Hmong, Somali, and White families). In-home observations include: (1) an interactive observational family task; (2) ecological momentary assessment of parent stress, mood, and parenting practices; (3) child and parent accelerometry; (4) three 24-hour child dietary recalls; (5) home food inventory; (6) built environment audit; (7) anthropometry on all family members; (8) an online survey; and (9) a parent interview. Phase I data will be used for analyses and to inform development of a culturally appropriate survey for Phase II. The survey will be administered at two time points to diverse parents (n=1200) of children ages 5-9. The main aim of the current paper is to describe the Family Matters complex study design and protocol and to report Phase I feasibility data for participant recruitment and study completion. Results from this comprehensive study will inform the development of culturally-tailored interventions to reduce childhood obesity disparities. Copyright © 2017 Elsevier Inc. All rights reserved.

Anterior Cruciate Ligament Reconstruction Rehabilitation

PubMed Central

Wright, Rick W.; Haas, Amanda K.; Anderson, Joy; Calabrese, Gary; Cavanaugh, John; Hewett, Timothy E.; Lorring, Dawn; McKenzie, Christopher; Preston, Emily; Williams, Glenn; Amendola, Annunziato

2015-01-01

Context: Anterior cruciate ligament (ACL) reconstruction rehabilitation has evolved over the past 20 years. This evolution has been driven by a variety of level 1 and level 2 studies. Evidence Acquisition: The MOON Group is a collection of orthopaedic surgeons who have developed a prospective longitudinal cohort of the ACL reconstruction patients. To standardize the management of these patients, we developed, in conjunction with our physical therapy committee, an evidence-based rehabilitation guideline. Study Design: Clinical review. Level of Evidence: Level 2. Results: This review was based on 2 systematic reviews of level 1 and level 2 studies. Recently, the guideline was updated by a new review. Continuous passive motion did not improve ultimate motion. Early weightbearing decreases patellofemoral pain. Postoperative rehabilitative bracing did not improve swelling, pain range of motion, or safety. Open chain quadriceps activity can begin at 6 weeks. Conclusion: High-level evidence exists to determine appropriate ACL rehabilitation guidelines. Utilizing this protocol follows the best available evidence. PMID:26131301

HIV-1 low copy viral sequencing-A prototype assay.

PubMed

Mellberg, Tomas; Krabbe, Jon; Gisslén, Magnus; Svennerholm, Bo

2016-01-01

In HIV-1 patients with low viral burden, sequencing is often problematic, yet important. This study presents a sensitive, sub-type independent system for sequencing of low level viremia. Sequencing data from 32 HIV-1 infected patients with low level viremia were collected longitudinally. A combination of ViroSeq® HIV-1 Genotyping System and an in-house nesting protocol was used. Eight sub-types were represented. The success-rate of amplification of both PR and RT in the same sample was 100% in samples with viral loads above 100 copies/ml. Below 100 copies/ml, this study managed to amplify both regions in 7/13 (54%) samples. The assays were able to amplify either PR or RT in all sub-types included but one sub-type A specimen. In conclusion, this study presents a promising, simple assay to increase the ability to perform HIV-1 resistance testing at low level viremia. This is a prototype assay and the method needs further testing to evaluate clinical performance.

Five-year multicenter study of magnetic attachments used for natural overdenture abutments.

PubMed

Gonda, T; Yang, T C; Maeda, Y

2013-04-01

The purpose of this study was to examine a longitudinal clinical performance of magnetic attachments used for natural overdenture abutments. The study included 131 patients who had used removable prostheses (complete overdentures 31%, partial dentures 69%) more than 5 years (40-90 years old) with 211 magnetic attachments on natural abutments (Magfit 400 or 600; Aichi Steel co., Aichi, Japan) treated in 15 clinics using a standardized protocol. Analyses were performed on the degree of patient satisfaction regarding retention, complications of magnets (corrosion, detachment from denture base), abutments (pain during mastication, periodontal pocket formation, inflammation, mobility), and dentures (fracture etc.). Ninety-seven percent of patients were satisfied with the retention and stability of their dentures. No corrosion of magnet was observed, and 19 magnets were detached. Most frequent complication of abutments was periodontal pocket formation (52%), followed by the inflammation (29%), increase in mobility (27%) and pain (4%). Magnetic attachment on natural tooth abutments provided a viable and long-term treatment option. © 2013 Blackwell Publishing Ltd.

Exploring the Waveform Characteristics of Tidal Breathing Carbon Dioxide, Measured Using the N-Tidal C Device in Different Breathing Conditions (The General Breathing Record Study): Protocol for an Observational, Longitudinal Study.

PubMed

Neville, Daniel M; Rupani, Hitasha; Kalra, Paul R; Adeniji, Kayode; Quint, Matthew; De Vos, Ruth; Begum, Selina; Mottershaw, Mark; Fogg, Carole; Jones, Thomas L; Lanning, Eleanor; Bassett, Paul; Chauhan, Anoop J

2018-05-24

In an increasingly comorbid population, there are significant challenges to diagnosing the cause of breathlessness, and once diagnosed, considerable difficulty in detecting deterioration early enough to provide effective intervention. The burden of the breathless patient on the health care economy is substantial, with asthma, chronic heart failure, and pneumonia affecting over 6 million people in the United Kingdom alone. Furthermore, these patients often have more than one contributory factor to their breathlessness symptoms, with conditions such as dysfunctional breathing pattern disorders-an under-recognized component. Current methods of diagnosing and monitoring breathless conditions can be extensive and difficult to perform. As a consequence, home monitoring is poorly complied with. In contrast, capnography (the measurement of tidal breath carbon dioxide) is performed during normal breathing. There is a need for a simple, easy-to-use, personal device that can aid in the diagnosis and monitoring of respiratory and cardiac causes of breathlessness. The aim of this study was to explore the use of a new, handheld capnometer (called the N-Tidal C) in different conditions that cause breathlessness. We will study whether the tidal breath carbon dioxide (TBCO 2 ) waveform, as measured by the N-Tidal C, has different characteristics in a range of respiratory and cardiac conditions. We will perform a longitudinal, observational study of the TBCO 2 waveform (capnogram) as measured by the N-Tidal C capnometer. Participants with a confirmed diagnosis of asthma, breathing pattern disorders, chronic heart failure, motor neurone disease, pneumonia, as well as volunteers with no history of lung disease will be asked to provide twice daily, 75-second TBCO 2 collection via the N-Tidal C device for 6 months duration. The collated capnograms will be correlated with the underlying diagnosis and disease state (stable or exacerbation) to determine if there are different TBCO 2 characteristics that can distinguish different respiratory and cardiac causes of breathlessness. This study's recruitment is ongoing. It is anticipated that the results will be available in late 2018. The General Breathing Record Study will provide an evaluation of the use of capnography as a diagnostic and home-monitoring tool for various diseases. RR1-10.2196/9767. ©Daniel M Neville, Hitasha Rupani, Paul R Kalra, Kayode Adeniji, Matthew Quint, Ruth De Vos, Selina Begum, Mark Mottershaw, Carole Fogg, Thomas L Jones, Eleanor Lanning, Paul Bassett, Anoop J Chauhan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.05.2018.

Prevalence and predictors of anxiety and depression after completion of chemotherapy for childhood acute lymphoblastic leukemia: A prospective longitudinal study.

PubMed

Kunin-Batson, Alicia S; Lu, Xiaomin; Balsamo, Lyn; Graber, Kelsey; Devidas, Meenakshi; Hunger, Stephen P; Carroll, William L; Winick, Naomi J; Mattano, Leonard A; Maloney, Kelly W; Kadan-Lottick, Nina S

2016-05-15

The months immediately after the completion of treatment for childhood acute lymphoblastic leukemia (ALL) are often regarded as a stressful time for children and families. In this prospective, longitudinal study, the prevalence and predictors of anxiety and depressive symptoms after the completion of treatment were examined. Participants included 160 children aged 2 to 9 years with standard-risk ALL who were enrolled on Children's Oncology Group protocol AALL0331. Parents completed standardized rating scales of their children's emotional-behavioral functioning and measures of coping and family functioning at approximately 1 month, 6 months, and 12 months after diagnosis and again 3 months after the completion of chemotherapy. At 3 months off therapy, approximately 24% of survivors had at-risk/clinically elevated anxiety scores and 28% had elevated depression scores, which are significantly higher than the expected 15% in the general population (P = .028 and .001, respectively). Patients with elevated anxiety 1 month after diagnosis were at greater risk of off-therapy anxiety (odds ratio, 4.1; 95% confidence interval, 1.31-12.73 [P = .022]) and those with elevated depressive symptoms 6 months after diagnosis were at greater risk of off-therapy depression (odds ratio, 7.88; 95% confidence interval, 2.61-23.81 [P = .0002]). In adjusted longitudinal analyses, unhealthy family functioning (P = .008) and less reliance on social support coping (P = .009) were found to be associated with risk of emotional distress. Children from Spanish-speaking families (P = .05) also were found to be at a greater risk of distress. A significant percentage of children experience emotional distress during and after therapy for ALL. These data provide a compelling rationale for targeted early screening and psychosocial interventions to support family functioning and coping skills. Cancer 2016;122:1608-17. © 2015 American Cancer Society. © 2016 American Cancer Society.

Scan-rescan precision of subchondral bone curvature maps from routine 3D DESS water excitation sequences: Data from the Osteoarthritis Initiative.

PubMed

Farber, Joshua M; Totterman, Saara M S; Martinez-Torteya, Antonio; Tamez-Peña, Jose G

2016-02-01

Subchondral bone (SCB) undergoes changes in the shape of the articulating bone surfaces and is currently recognized as a key target in osteoarthritis (OA) treatment. The aim of this study was to present an automated system that determines the curvature of the SCB regions of the knee and to evaluate its cross-sectional and longitudinal scan-rescan precision Six subjects with OA and six control subjects were selected from the Osteoarthritis Initiative (OAI) pilot study database. As per OAI protocol, these subjects underwent 3T MRI at baseline and every twelve months thereafter, including a 3D DESS WE sequence. We analyzed the baseline and twenty-four month images. Each subject was scanned twice at these visits, thus generating scan-rescan information. Images were segmented with an automated multi-atlas framework platform and then 3D renderings of the bone structure were created from the segmentations. Curvature maps were extracted from the 3D renderings and morphed into a reference atlas to determine precision, to generate population statistics, and to visualize cross-sectional and longitudinal curvature changes. The baseline scan-rescan root mean square error values ranged from 0.006mm(-1) to 0.013mm(-1), and from 0.007mm(-1) to 0.018mm(-1) for the SCB of the femur and the tibia, respectively. The standardized response of the mean of the longitudinal changes in curvature in these regions ranged from -0.09 to 0.02 and from -0.016 to 0.015, respectively. The fully automated system produces accurate and precise curvature maps of femoral and tibial SCB, and will provide a valuable tool for the analysis of the curvature changes of articulating bone surfaces during the course of knee OA. Copyright © 2015 Elsevier Ltd. All rights reserved.

Left ventricular myocardial velocities and deformation indexes in top-level athletes.

PubMed

D'Andrea, Antonello; Cocchia, Rosangela; Riegler, Lucia; Scarafile, Raffaella; Salerno, Gemma; Gravino, Rita; Golia, Enrica; Pezzullo, Enrica; Citro, Rodolfo; Limongelli, Giuseppe; Pacileo, Giuseppe; Cuomo, Sergio; Caso, Pio; Russo, Maria Giovanna; Bossone, Eduardo; Calabrò, Raffaele

2010-12-01

The aim of this study was to define the range of left ventricular (LV) velocities and deformation indexes in highly trained athletes, analyzing potential differences induced by different long-term training protocols. Standard echocardiography, pulsed-wave tissue Doppler echocardiography, and two-dimensional strain echocardiography of the interventricular septum and lateral wall were performed in 370 endurance athletes and 280 power athletes. Using pulsed-wave tissue Doppler, the following parameters of myocardial function were assessed: systolic peak velocities (S(m)), early (E(m)) and late (A(m)) diastolic velocities, and the E(m)/A(m) ratio. By two-dimensional strain echocardiography, peaks of regional systolic strain and LV global longitudinal strain were calculated. LV mass index and ejection fraction did not significantly differ between the two groups. However, power athletes showed an increased sum of wall thicknesses (P < .01) and relative wall thickness, while LV stroke volume and LV end-diastolic diameter (P < .001) were greater in endurance athletes. By pulsed-wave tissue Doppler analysis, E(m) and E(m)/A(m) at both the septal and lateral wall levels were higher in endurance athletes. By two-dimensional strain echocardiography, myocardial deformation indexes were comparable between the two groups. E(m)/A(m) ratios ≥ 1 were found in the overall population, while 90 % of athletes had an E(m) ≥ 16 cm/sec, S(m) ≥ 10 cm/sec, and global longitudinal strain ≤ -16%. Multivariate analyses evidenced independent positive association between Em peak velocity and LV end-diastolic volume (P < .001) and an independent correlation of global longitudinal strain with the sum of LV wall thicknesses (P < .005). This study describes the full spectrum of systolic and diastolic myocardial velocities and deformation indexes in a large population of competitive athletes. Copyright © 2010 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.

Protocol for a prospective longitudinal study of risk factors for hypertension incidence in a Mexico City population: the Tlalpan 2020 cohort

PubMed Central

Colín-Ramírez, Eloisa; Rivera-Mancía, Susana; Infante-Vázquez, Oscar; Cartas-Rosado, Raúl; Vargas-Barrón, Jesús; Madero, Magdalena; Vallejo, Maite

2017-01-01

Introduction Systemic hypertension (HTN) is a common risk factor for cardiovascular disease. In Mexico, HTN prevalence has increased over time and is currently 31%. Nonetheless, information about the country's HTN incidence and its associated risk factors is scarce. Understanding this condition is a priority for identifying the scope of primary prevention. The main objective of this study is to evaluate the effect of traditional and non-traditional risk factors on the incidence of HTN in a cohort of healthy Mexico City residents under biannual follow-up for 10 years. Methods and analysis A prospective longitudinal study is proposed in which clinically healthy residents of Mexico City between 20 and 50 years old will be recruited; the participants will be evaluated every 2 years over a period of 10 years or until they develop HTN. Evaluations regarding sociodemographic, clinical, anthropometric, biochemical, diet, physical activity, stress, sleep quality, alcohol and tobacco consumption factors will be performed. The participants will be recruited from the 16 municipalities of Mexico City through promotional strategies aimed at the community and will be clinically evaluated at a tertiary care institution, Instituto Nacional de Cardiología Ignacio Chávez (National Institute of Cardiology Ignacio Chavez), located in Mexico City, Mexico. Sample size estimated for this study is 3436, and the Cox proportional hazards model will be used to estimate HRs for the association between explanatory variables and HTN using both raw and adjusted data. Ethics and dissemination This study was approved by the Institutional Bioethics Committee of the Instituto Nacional de Cardiología Ignacio Chávez (National Institute of Cardiology Ignacio Chavez) under number 13-802. Findings from this study will be disseminated through scientific papers and research conferences. PMID:28760800

Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

NASA Astrophysics Data System (ADS)

Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

2014-02-01

Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

The Canadian Assessment of Physical Literacy: Development of a Model of Children's Capacity for a Healthy, Active Lifestyle Through a Delphi Process.

PubMed

Francis, Claire E; Longmuir, Patricia E; Boyer, Charles; Andersen, Lars Bo; Barnes, Joel D; Boiarskaia, Elena; Cairney, John; Faigenbaum, Avery D; Faulkner, Guy; Hands, Beth P; Hay, John A; Janssen, Ian; Katzmarzyk, Peter T; Kemper, Han C; Knudson, Duane; Lloyd, Meghann; McKenzie, Thomas L; Olds, Tim S; Sacheck, Jennifer M; Shephard, Roy J; Zhu, Weimo; Tremblay, Mark S

2016-02-01

The Canadian Assessment of Physical Literacy (CAPL) was conceptualized as a tool to monitor children's physical literacy. The original model (fitness, activity behavior, knowledge, motor skill) required revision and relative weights for calculating/interpreting scores were required. Nineteen childhood physical activity/fitness experts completed a 3-round Delphi process. Round 1 was open-ended questions. Subsequent rounds rated statements using a 5-point Likert scale. Recommendations were sought regarding protocol inclusion, relative importance within composite scores and score interpretation. Delphi participant consensus was achieved for 64% (47/73) of statement topics, including a revised conceptual model, specific assessment protocols, the importance of longitudinal tracking, and the relative importance of individual protocols and composite scores. Divergent opinions remained regarding the inclusion of sleep time, assessment/ scoring of the obstacle course assessment of motor skill, and the need for an overall physical literacy classification. The revised CAPL model (overlapping domains of physical competence, motivation, and knowledge, encompassed by daily behavior) is appropriate for monitoring the physical literacy of children aged 8 to 12 years. Objectively measured domains (daily behavior, physical competence) have higher relative importance. The interpretation of CAPL results should be reevaluated as more data become available.

Application of confocal Raman micro-spectroscopy for label-free monitoring of oxidative stress in living bronchial cells

NASA Astrophysics Data System (ADS)

Surmacki, Jakub M.; Quirós Gonzalez, Isabel; Bohndiek, Sarah E.

2018-02-01

Oxidative stress in cancer is implicated in tumor progression, being associated with increased therapy resistance and metastasis. Conventional approaches for monitoring oxidative stress in tissue such as high-performance liquid chromatography and immunohistochemistry are bulk measurements and destroy the sample, meaning that longitudinal monitoring of cancer cell heterogeneity remains elusive. Raman spectroscopy has the potential to overcome this challenge, providing a chemically specific, label free readout from single living cells. Here, we applied a standardized protocol for label-free confocal Raman micro-spectroscopy in living cells to monitor oxidative stress in bronchial cells. We used a quartz substrate in a commercial cell chamber contained within a microscope incubator providing culture media for cell maintenance. We studied the effect of a potent reactive oxygen species inducer, tert-butyl hydroperoxide (TBHP), and antioxidant, N-acetyl-L-cysteine (NAC) on living cells from a human bronchial epithelial cells (HBEC). We found that the Raman bands corresponding to nucleic acids, proteins and lipids were significantly different (p<0.05) for control, TBHP, and NAC. Encouragingly, partial least squares discriminant analysis applied to our data showed high sensitivity and specificity for identification of control (87.3%, 71.7%), NAC (92.3%, 85.1%) and TBHP (86.9%, 92.9%). These results suggest that confocal Raman micro-spectroscopy may be able to monitor the biological impact of oxidative and reductive processes in cells, hence enabling longitudinal studies of oxidative stress in therapy resistance and metastasis at the single cell level.

Exponential Speedup of Quantum Annealing by Inhomogeneous Driving of the Transverse Field

NASA Astrophysics Data System (ADS)

Susa, Yuki; Yamashiro, Yu; Yamamoto, Masayuki; Nishimori, Hidetoshi

2018-02-01

We show, for quantum annealing, that a certain type of inhomogeneous driving of the transverse field erases first-order quantum phase transitions in the p-body interacting mean-field-type model with and without longitudinal random field. Since a first-order phase transition poses a serious difficulty for quantum annealing (adiabatic quantum computing) due to the exponentially small energy gap, the removal of first-order transitions means an exponential speedup of the annealing process. The present method may serve as a simple protocol for the performance enhancement of quantum annealing, complementary to non-stoquastic Hamiltonians.

Dose profile variation with voltage in head CT scans using radiochromic films

NASA Astrophysics Data System (ADS)

Mourão, A. P.; Alonso, T. C.; DaSilva, T. A.

2014-02-01

The voltage source used in an X-ray tube is an important part of defining the generated beam spectrum energy profile. The X-ray spectrum energy defines the X-ray beam absorption as well as the characteristics of the energy deposition in an irradiated object. Although CT scanners allow one to choose between four different voltage values, most of them employ a voltage of 120 kV in their scanning protocols, regardless of the patient characteristics. Based on this fact, this work investigated the deposited dose in a polymethyl methacrylate (PMMA) cylindrical head phantom. The entire volume was irradiated twice. Two CT scanning protocols were used with two different voltage values: 100 and 120 kV. The phantom volume was irradiated, and radiochromic films were employed to record dose profiles. Measurements were conducted with a calibrated pencil ionization chamber, which was positioned in the center and in four peripheral bores of the head PMMA phantom, to calibrate the radiochromic films. The central slice was then irradiated. This procedure allowed us to find the conversion factors necessary to obtain dose values recorded in the films. The data obtained allowed us to observe the dose variation profile inside the phantom head as well as in the peripheral and central regions. The peripheral region showed higher dose values than those of the central region for scans using both voltage values: approximately 31% higher for scanning with 120 kV and 25% higher with 100 kV. Doses recorded with the highest voltage are significantly higher, approximately 50% higher in the peripheral region and 40% higher in the central region. A longitudinal variation could be observed, and the maximum dose was recorded at the peripheral region, at the midpoint of the longitudinal axis. The obtained results will most likely contribute to the dissemination of proper procedure as well as to optimize dosimetry and tests of quality control in CT because the choice of protocols with different voltage values can be a way to optimize the CT scans.

Extracting aerobic system dynamics during unsupervised activities of daily living using wearable sensor machine learning models.

PubMed

Beltrame, Thomas; Amelard, Robert; Wong, Alexander; Hughson, Richard L

2018-02-01

Physical activity levels are related through algorithms to the energetic demand, with no information regarding the integrity of the multiple physiological systems involved in the energetic supply. Longitudinal analysis of the oxygen uptake (V̇o 2 ) by wearable sensors in realistic settings might permit development of a practical tool for the study of the longitudinal aerobic system dynamics (i.e., V̇o 2 kinetics). This study evaluated aerobic system dynamics based on predicted V̇o 2 data obtained from wearable sensors during unsupervised activities of daily living (μADL). Thirteen healthy men performed a laboratory-controlled moderate exercise protocol and were monitored for ≈6 h/day for 4 days (μADL data). Variables derived from hip accelerometer (ACC HIP ), heart rate monitor, and respiratory bands during μADL were extracted and processed by a validated random forest regression model to predict V̇o 2 . The aerobic system analysis was based on the frequency-domain analysis of ACC HIP and predicted V̇o 2 data obtained during μADL. Optimal samples for frequency domain analysis (constrained to ≤0.01 Hz) were selected when ACC HIP was higher than 0.05 g at a given frequency (i.e., participants were active). The temporal characteristics of predicted V̇o 2 data during μADL correlated with the temporal characteristics of measured V̇o 2 data during laboratory-controlled protocol ([Formula: see text] = 0.82, P < 0.001, n = 13). In conclusion, aerobic system dynamics can be investigated during unsupervised activities of daily living by wearable sensors. Although speculative, these algorithms have the potential to be incorporated into wearable systems for early detection of changes in health status in realistic environments by detecting changes in aerobic response dynamics. NEW & NOTEWORTHY The early detection of subclinical aerobic system impairments might be indicative of impaired physiological reserves that impact the capacity for physical activity. This study is the first to use wearable sensors in unsupervised activities of daily living in combination with novel machine learning algorithms to investigate the aerobic system dynamics with the potential to contribute to models of functional health status and guide future individualized health care in the normal population.

Accelerometer-based physical activity in a large observational cohort--study protocol and design of the activity and function of the elderly in Ulm (ActiFE Ulm) study.

PubMed

Denkinger, Michael D; Franke, Sebastian; Rapp, Kilian; Weinmayr, Gudrun; Duran-Tauleria, Enric; Nikolaus, Thorsten; Peter, Richard

2010-07-27

A large number of studies have demonstrated a positive effect of increased physical activity (PA) on various health outcomes. In all large geriatric studies, however, PA has only been assessed by interview-based instruments which are all subject to substantial bias. This may represent one reason why associations of PA with geriatric syndromes such as falls show controversial results. The general aim of the Active-Ulm study was to determine the association of accelerometer-based physical activity with different health-related parameters, and to study the influence of this standardized objective measure of physical activity on health- and disability-related parameters in a longitudinal setting. We have set up an observational cohort study in 1500 community dwelling older persons (65 to 90 years) stratified by age and sex. Addresses have been obtained from the local residents registration offices. The study is carried out jointly with the IMCA--Respiratory Health Survey in the Elderly implemented in the context of the European project IMCA II. The study has a cross-sectional part (1) which focuses on PA and disability and two longitudinal parts (2) and (3). The primary information for part (2) is a prospective 1 year falls calendar including assessment of medication change. Part (3) will be performed about 36 months following baseline. Primary variables of interest include disability, PA, falls and cognitive function. Baseline recruitment has started in March 2009 and will be finished in April 2010.All participants are visited three times within one week, either at home or in the study center. Assessments included interviews on quality of life, diagnosed diseases, common risk factors as well as novel cognitive tests and established tests of physical functioning. PA is measured using an accelerometer-based sensor device, carried continuously over a one week period and accompanied by a prospective activity diary. The assessment of PA using a high standard accelerometer-based device is feasible in a large population-based study. The results obtained from cross-sectional and longitudinal analyses will shed light on important associations between PA and various outcomes and may provide information for specific interventions in older people.

Design of a short nonuniform acquisition protocol for quantitative analysis in dynamic cardiac SPECT imaging - a retrospective 123 I-MIBG animal study.

PubMed

Zan, Yunlong; Long, Yong; Chen, Kewei; Li, Biao; Huang, Qiu; Gullberg, Grant T

2017-07-01

Our previous works have found that quantitative analysis of 123 I-MIBG kinetics in the rat heart with dynamic single-photon emission computed tomography (SPECT) offers the potential to quantify the innervation integrity at an early stage of left ventricular hypertrophy. However, conventional protocols involving a long acquisition time for dynamic imaging reduce the animal survival rate and thus make longitudinal analysis difficult. The goal of this work was to develop a procedure to reduce the total acquisition time by selecting nonuniform acquisition times for projection views while maintaining the accuracy and precision of estimated physiologic parameters. Taking dynamic cardiac imaging with 123 I-MIBG in rats as an example, we generated time activity curves (TACs) of regions of interest (ROIs) as ground truths based on a direct four-dimensional reconstruction of experimental data acquired from a rotating SPECT camera, where TACs represented as the coefficients of B-spline basis functions were used to estimate compartmental model parameters. By iteratively adjusting the knots (i.e., control points) of B-spline basis functions, new TACs were created according to two rules: accuracy and precision. The accuracy criterion allocates the knots to achieve low relative entropy between the estimated left ventricular blood pool TAC and its ground truth so that the estimated input function approximates its real value and thus the procedure yields an accurate estimate of model parameters. The precision criterion, via the D-optimal method, forces the estimated parameters to be as precise as possible, with minimum variances. Based on the final knots obtained, a new protocol of 30 min was built with a shorter acquisition time that maintained a 5% error in estimating rate constants of the compartment model. This was evaluated through digital simulations. The simulation results showed that our method was able to reduce the acquisition time from 100 to 30 min for the cardiac study of rats with 123 I-MIBG. Compared to a uniform interval dynamic SPECT protocol (1 s acquisition interval, 30 min acquisition time), the newly proposed protocol with nonuniform interval achieved comparable (K1 and k2, P = 0.5745 for K1 and P = 0.0604 for k2) or better (Distribution Volume, DV, P = 0.0004) performance for parameter estimates with less storage and shorter computational time. In this study, a procedure was devised to shorten the acquisition time while maintaining the accuracy and precision of estimated physiologic parameters in dynamic SPECT imaging. The procedure was designed for 123 I-MIBG cardiac imaging in rat studies; however, it has the potential to be extended to other applications, including patient studies involving the acquisition of dynamic SPECT data. © 2017 American Association of Physicists in Medicine.

Transdisciplinary research for impact: protocol for a realist evaluation of the relationship between transdisciplinary research collaboration and knowledge translation.

PubMed

Archibald, Mandy M; Lawless, Michael; Harvey, Gillian; Kitson, Alison L

2018-04-07

Transdisciplinary teams are increasingly regarded as integral to conducting effective research. Similarly, knowledge translation is often seen as a solution to improving the relevance and benefits of health research. Yet, whether, how, for whom and under which circumstances transdisciplinary research influences knowledge translation is undertheorised, which limits its potential impact. The proposed research aims to identify the contexts and mechanisms by which transdisciplinary research contributes to developing shared understandings and behaviours of knowledge translation between team members. Using a longitudinal case-study design approach to realist evaluation, we outline a study protocol examining whether, how, if and for whom transdisciplinary collaboration can impact knowledge translation understandings and behaviours within a 5-year transdisciplinary Centre of Research Excellence. Data are being collected between February 2017 and December 2020 over four rounds of theory development, refinement and testing using interviews, observation, document review and visual elicitation as data sources. The Health Research Ethics Committee of the University of Adelaide approved this study. Findings will be communicated with team members at scheduled intervals throughout the study verbally and by means of creative reflective approaches (eg, arts elicitation, journalling). This research will be used to help support optimal team functioning by identifying strategies to support knowledge sharing and communication within and beyond the team to facilitate attainment of research objectives. Academic dissemination will occur through publication and presentations. © 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.

Engagement Strategies for Self-Monitoring Symptoms of Bipolar Disorder With Mobile and Wearable Technology: Protocol for a Randomized Controlled Trial.

PubMed

Cochran, Amy; Belman-Wells, Livia; McInnis, Melvin

2018-05-10

Monitoring signs and symptoms in bipolar disorder (BP) is typically based on regular assessments from patient-clinician interactions. Mobile and wearable technology promises to make monitoring symptoms in BP easier, but little is known about how best to engage individuals with BP in monitoring symptoms. The objective of this study was to provide the rationale and protocol for a randomized controlled trial that investigates engagement strategies for monitoring symptoms of BP, including the strategies of using activity trackers compared with self-reports and reviewing recorded symptoms weekly with an interviewer. A total of 50 individuals with BP will be recruited from the Prechter Longitudinal Study of Bipolar Disorder at the University of Michigan to participate in a 6-week study. Participants will monitor their symptoms through an activity tracker (Fitbit Alta HR) and a mobile phone app designed for this study. In addition to monitoring symptoms, participants have a 50-50 chance of being assigned to an arm that reviews self-reports and activity information weekly. Statistical tests will be performed to test hypotheses that participants adhere to activity tracking significantly more than self-reporting, prefer activity tracking significantly more than self-reporting, and better adhere to both activity tracking and self-reporting when reviewing collected information weekly. Recruitment commenced in November 2017. The first group of participants began the study in January 2018. This study aims to establish strategies to engage individuals with BP in monitoring their symptoms with mobile and wearable technology. Better engagement strategies are expected to aid current efforts in bipolar research and clinical care, from the development of new mobile phone apps to providing the right intervention to the right individual at the right moment. ClinicalTrials.gov NCT03358238; https://clinicaltrials.gov/ct2/show/NCT03358238 (Archived by WebCite at http://www.webcitation.org/6yebuNfz5). RR1-10.2196/9899. ©Amy Cochran, Livia Belman-Wells, Melvin McInnis. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.05.2018.

Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial.

PubMed

Pozet, Astrid; Lejeune, Catherine; Bonnet, Magalie; Dabakuyo, Sandrine; Dion, Michèle; Fagnoni, Philippe; Gaimard, Maryse; Imbert, Geneviève; Nerich, Virginie; Foubert, Audrey; Chotard, Morgane; Bonin, Marie; Anota, Amélie; Bonnetain, Franck

2016-11-03

Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and diversity of informal tasks may jeopardize the physical, mental and social wellbeing of caregivers. The aim of the Informal Carers of Elderly cohort is to define, through a longitudinal study, profiles of caregivers of older patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colorectal), neurodegenerative diseases (Parkinson's disease, Alzheimer's disease and similar diseases), neurovascular diseases (stroke), sensory diseases (age-related macular degeneration (AMD)) and heart disease (heart failure). Patients must be at least 60 years old and living in the region of Burgundy-Franche-Comte (France). By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers, coping strategies, levels of anxiety and depression, social support and the extent of their burden. We will also evaluate the efficacy and efficiency of the implementation of a pragmatic intervention by a social worker to help informal caregivers, through a randomized interventional trial nested in the cohort. Qualitative approaches aimed at studying the caregiver/patient relationship, and situations leading to breakdown of the caregiver relationship will be also undertaken. Through an analytical and longitudinal definition of profiles of informal caregivers, this study will gather detailed information on their life courses and their health trajectory by identifying consequences associated with the concept of their role as carers. In addition, the randomized interventional trial will explore the relevance of the implementation of a supportive intervention by a social worker to help caregivers. These data will help to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support adapted to caregivers, and provide an impulse for new health care policies. ClinicalTrials.gov Identifier: NCT02626377 . Retrospectively registered on 9 December 2015. Protocol date/version: 23 October 2014/version 2.

High-resolution fiber-optic microendoscopy for in situ cellular imaging.

PubMed

Pierce, Mark; Yu, Dihua; Richards-Kortum, Rebecca

2011-01-11

Many biological and clinical studies require the longitudinal study and analysis of morphology and function with cellular level resolution. Traditionally, multiple experiments are run in parallel, with individual samples removed from the study at sequential time points for evaluation by light microscopy. Several intravital techniques have been developed, with confocal, multiphoton, and second harmonic microscopy all demonstrating their ability to be used for imaging in situ. With these systems, however, the required infrastructure is complex and expensive, involving scanning laser systems and complex light sources. Here we present a protocol for the design and assembly of a high-resolution microendoscope which can be built in a day using off-the-shelf components for under US$5,000. The platform offers flexibility in terms of image resolution, field-of-view, and operating wavelength, and we describe how these parameters can be easily modified to meet the specific needs of the end user. We and others have explored the use of the high-resolution microendoscope (HRME) in in vitro cell culture, in excised and living animal tissues, and in human tissues in vivo. Users have reported the use of several different fluorescent contrast agents, including proflavine, benzoporphyrin-derivative monoacid ring A (BPD-MA), and fluoroscein, all of which have received full, or investigational approval from the FDA for use in human subjects. High-resolution microendoscopy, in the form described here, may appeal to a wide range of researchers working in the basic and clinical sciences. The technique offers an effective and economical approach which complements traditional benchtop microscopy, by enabling the user to perform high-resolution, longitudinal imaging in situ.

Ecological Momentary Assessment in Behavioral Research: Addressing Technological and Human Participant Challenges

PubMed Central

Shiffman, Saul; Music, Edvin; Styn, Mindi A; Kriska, Andrea; Smailagic, Asim; Siewiorek, Daniel; Ewing, Linda J; Chasens, Eileen; French, Brian; Mancino, Juliet; Mendez, Dara; Strollo, Patrick; Rathbun, Stephen L

2017-01-01

Background Ecological momentary assessment (EMA) assesses individuals’ current experiences, behaviors, and moods as they occur in real time and in their natural environment. EMA studies, particularly those of longer duration, are complex and require an infrastructure to support the data flow and monitoring of EMA completion. Objective Our objective is to provide a practical guide to developing and implementing an EMA study, with a focus on the methods and logistics of conducting such a study. Methods The EMPOWER study was a 12-month study that used EMA to examine the triggers of lapses and relapse following intentional weight loss. We report on several studies that informed the implementation of the EMPOWER study: (1) a series of pilot studies, (2) the EMPOWER study’s infrastructure, (3) training of study participants in use of smartphones and the EMA protocol and, (4) strategies used to enhance adherence to completing EMA surveys. Results The study enrolled 151 adults and had 87.4% (132/151) retention rate at 12 months. Our learning experiences in the development of the infrastructure to support EMA assessments for the 12-month study spanned several topic areas. Included were the optimal frequency of EMA prompts to maximize data collection without overburdening participants; the timing and scheduling of EMA prompts; technological lessons to support a longitudinal study, such as proper communication between the Android smartphone, the Web server, and the database server; and use of a phone that provided access to the system’s functionality for EMA data collection to avoid loss of data and minimize the impact of loss of network connectivity. These were especially important in a 1-year study with participants who might travel. It also protected the data collection from any server-side failure. Regular monitoring of participants’ response to EMA prompts was critical, so we built in incentives to enhance completion of EMA surveys. During the first 6 months of the 12-month study interval, adherence to completing EMA surveys was high, with 88.3% (66,978/75,888) completion of random assessments and around 90% (23,411/25,929 and 23,343/26,010) completion of time-contingent assessments, despite the duration of EMA data collection and challenges with implementation. Conclusions This work informed us of the necessary preliminary steps to plan and prepare a longitudinal study using smartphone technology and the critical elements to ensure participant engagement in the potentially burdensome protocol, which spanned 12 months. While this was a technology-supported and -programmed study, it required close oversight to ensure all elements were functioning correctly, particularly once human participants became involved. PMID:28298264

The Evolving MCART Multimodal Imaging Core: Establishing a protocol for Computed Tomography and Echocardiography in the Rhesus macaque to perform longitudinal analysis of radiation-induced organ injury

PubMed Central

de Faria, Eduardo B.; Barrow, Kory R.; Ruehle, Bradley T.; Parker, Jordan T.; Swartz, Elisa; Taylor-Howell, Cheryl; Kieta, Kaitlyn M.; Lees, Cynthia J.; Sleeper, Meg M.; Dobbin, Travis; Baron, Adam D.; Mohindra, Pranshu; MacVittie, Thomas J.

2015-01-01

Computed Tomography (CT) and Echocardiography (EC) are two imaging modalities that produce critical longitudinal data that can be analyzed for radiation-induced organ-specific injury to the lung and heart. The Medical Countermeasures Against Radiological Threats (MCART) consortium has a well-established animal model research platform that includes nonhuman primate (NHP) models of the acute radiation syndrome and the delayed effects of acute radiation exposure. These models call for a definition of the latency, incidence, severity, duration, and resolution of different organ-specific radiation-induced subsyndromes. The pulmonary subsyndromes and cardiac effects are a pair of inter-dependent syndromes impacted by exposure to potentially lethal doses of radiation. Establishing a connection between these will reveal important information about their interaction and progression of injury and recovery. Herein, we demonstrate the use of CT and EC data in the rhesus macaque models to define delayed organ injury thereby establishing: a) consistent and reliable methodology to assess radiation-induced damage to the lung and heart, b) an extensive database in normal age-matched NHP for key primary and secondary endpoints, c) identified problematic variables in imaging techniques and proposed solutions to maintain data integrity and d) initiated longitudinal analysis of potentially lethal radiation-induced damage to the lung and heart. PMID:26425907

Isotopic characterization of flight feathers in two pelagic seabirds: Sampling strategies for ecological studies

USGS Publications Warehouse

Wiley, Anne E.; Ostrom, Peggy H.; Stricker, Craig A.; James, Helen F.; Gandhi, Hasand

2010-01-01

We wish to use stable-isotope analysis of flight feathers to understand the feeding behavior of pelagic seabirds, such as the Hawaiian Petrel (Pterodroma sandwichensis) and Newell’s Shearwater (Puffinus auricularis newelli). Analysis of remiges is particularly informative because the sequence and timing of remex molt are often known. The initial step, reported here, is to obtain accurate isotope values from whole remiges by means of a minimally invasive protocol appropriate for live birds or museum specimens. The high variability observed in D13C and D15N values within a feather precludes the use of a small section of vane. We found the average range within 42 Hawaiian Petrel remiges to be 1.3‰ for both D13C and D15N and that within 10 Newell’s Shearwater remiges to be 1.3‰ and 0.7‰ for D13C and D15N, respectively. The D13C of all 52 feathers increased from tip to base, and the majority of Hawaiian Petrel feathers showed an analogous trend in D15N. Although the average range of DD in 21 Hawaiian Petrel remiges was 11‰, we found no longitudinal trend. We discuss influences of trophic level, foraging location, metabolism, and pigmentation on isotope values and compare three methods of obtaining isotope averages of whole feathers. Our novel barb-sampling protocol requires only 1.0 mg of feather and minimal preparation time. Because it leaves the feather nearly intact, this protocol will likely facilitate obtaining isotope values from remiges of live birds and museum specimens. As a consequence, it will help expand the understanding of historical trends in foraging behavior

Stimulated echo diffusion tensor imaging and SPAIR T2-weighted imaging in Chronic Exertional Compartment Syndrome of the lower leg muscles

PubMed Central

Sigmund, Eric E.; Sui, Dabang; Ukpebor, Obehi; Baete, Steven; Fieremans, Els; Babb, James S.; Mechlin, Michael; Liu, Kecheng; Kwon, Jane; Mcgorty, KellyAnne; Hodnett, Phil; Bencardino, Jenny

2013-01-01

Purpose To evaluate the performance of diffusion tensor imaging (DTI) in the evaluation of chronic exertional compartment syndrome (CECS) as compared to T2-weighted imaging. Materials and Methods Using an IRB-approved HIPAA-compliant protocol, spectral adiabatic inversion recovery (SPAIR) T2-weighted imaging (T2w) and stimulated echo DTI were applied to 8 healthy volunteers and 14 suspected CECS patients before and after exertion. Longitudinal and transverse diffusion eigenvalues, mean diffusivity (MD), and fractional anisotropy (FA) were measured in 7 calf muscle compartments, which in patients were classified by their response on T2w: normal (<20% change), and CECS (>20% change). Mixed model analysis of variance compared subject groups and compartments in terms of response factors (post-/pre-exercise ratios) of DTI parameters. Results All diffusivities significantly increased (p<0.0001) and FA decreased (p=.0014) with exercise. Longitudinal diffusion responses were significantly smaller than transversal diffusion responses (p<0.0001). 19 of 98 patient compartments were classified as CECS on T2w. MD increased by 3.8±3.4% (volunteer), 7.4±4.2 % (normal), and 9.1±7.0% (CECS) with exercise. Conclusion DTI shows promise as an ancillary imaging method in the diagnosis and understanding of the pathophysiology in CECS. Future studies may explore its utility in predicting response to treatment. PMID:23440764

A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol.

PubMed

Currow, David; Watts, Gareth John; Johnson, Miriam; McDonald, Christine F; Miners, John O; Somogyi, Andrew A; Denehy, Linda; McCaffrey, Nicola; Eckert, Danny J; McCloud, Philip; Louw, Sandra; Lam, Lawrence; Greene, Aine; Fazekas, Belinda; Clark, Katherine C; Fong, Kwun; Agar, Meera R; Joshi, Rohit; Kilbreath, Sharon; Ferreira, Diana; Ekström, Magnus

2017-07-17

Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD. The primary question is what effect regular ER morphine has on worst breathlessness, measured daily on a 0-10 numerical rating scale. Uniquely, the coprimary outcome will use a FitBit to measure habitual physical activity. Secondary questions include safety and, whether upward titration after initial benefit delivers greater net symptom reduction. Substudies include longitudinal driving simulation, sleep, caregiver, health economic and pharmacogenetic studies. Seventeen centres will recruit 171 participants from respiratory and palliative care. The study has five phases including three randomisation phases to increasing doses of ER morphine. All participants will receive placebo or active laxatives as appropriate. Appropriate statistical analysis of primary and secondary outcomes will be used. Ethics approval has been obtained. Results of the study will be submitted for publication in peer-reviewed journals, findings presented at relevant conferences and potentially used to inform registration of ER morphine for chronic breathlessness. NCT02720822; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol

PubMed Central

Watts, Gareth John; Johnson, Miriam; McDonald, Christine F; Miners, John O; Somogyi, Andrew A; Denehy, Linda; McCaffrey, Nicola; Eckert, Danny J; McCloud, Philip; Louw, Sandra; Lam, Lawrence; Greene, Aine; Fazekas, Belinda; Clark, Katherine C; Fong, Kwun; Agar, Meera R; Joshi, Rohit; Kilbreath, Sharon; Ferreira, Diana; Ekström, Magnus

2017-01-01

Introduction Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD. Methods and analysis The primary question is what effect regular ER morphine has on worst breathlessness, measured daily on a 0–10 numerical rating scale. Uniquely, the coprimary outcome will use a FitBit to measure habitual physical activity. Secondary questions include safety and, whether upward titration after initial benefit delivers greater net symptom reduction. Substudies include longitudinal driving simulation, sleep, caregiver, health economic and pharmacogenetic studies. Seventeen centres will recruit 171 participants from respiratory and palliative care. The study has five phases including three randomisation phases to increasing doses of ER morphine. All participants will receive placebo or active laxatives as appropriate. Appropriate statistical analysis of primary and secondary outcomes will be used. Ethics and dissemination Ethics approval has been obtained. Results of the study will be submitted for publication in peer-reviewed journals, findings presented at relevant conferences and potentially used to inform registration of ER morphine for chronic breathlessness. Trial registration number NCT02720822; Pre-results. PMID:28716797

Modular low-light microscope for imaging cellular bioluminescence and radioluminescence

PubMed Central

Kim, Tae Jin; Türkcan, Silvan; Pratx, Guillem

2017-01-01

Low-light microscopy methods are receiving increased attention as new applications have emerged. One such application is to allow longitudinal imaging of light-sensitive cells with no phototoxicity and no photobleaching of fluorescent biomarkers. Another application is for imaging signals that are inherently dim and undetectable using standard microscopy, such as bioluminescence, chemiluminescence, or radioluminescence. In this protocol, we provide instructions on how to build a modular low-light microscope (1-4 d) by coupling two microscope objective lenses, back-to-back from each other, using standard optomechanical components. We also provide directions on how to image dim signals such as radioluminescence (1-1.5 h), bioluminescence (∼30 min) and low-excitation fluorescence (∼15 min). In particular, radioluminescence microscopy is explained in detail as it is a newly developed technique, which enables the study of small molecule transport (eg. radiolabeled drugs, metabolic precursors, and nuclear medicine contrast agents) by single cells without perturbing endogenous biochemical processes. In this imaging technique, a scintillator crystal (eg. CdWO4) is placed in close proximity to the radiolabeled cells, where it converts the radioactive decays into optical flashes detectable using a sensitive camera. Using the image reconstruction toolkit provided in this protocol, the flashes can be reconstructed to yield high-resolution image of the radiotracer distribution. With appropriate timing, the three aforementioned imaging modalities may be performed altogether on a population of live cells, allowing the user to perform parallel functional studies of cell heterogeneity at the single-cell level. PMID:28426025

Brain stimulation-induced neuroplasticity underlying therapeutic response in phantom sounds.

PubMed

Poeppl, Timm B; Langguth, Berthold; Lehner, Astrid; Frodl, Thomas; Rupprecht, Rainer; Kreuzer, Peter M; Landgrebe, Michael; Schecklmann, Martin

2018-01-01

Noninvasive brain stimulation can modify phantom sounds for longer periods by modulating neural activity and putatively inducing regional neuroplastic changes. However, treatment response is limited and there are no good demographic or clinical predictors for treatment outcome. We used state-of-the-art voxel-based morphometry (VBM) to investigate whether transcranial magnetic stimulation-induced neuroplasticity determines therapeutic outcome. Sixty subjects chronically experiencing phantom sounds (i.e., tinnitus) received repetitive transcranial magnetic stimulation (rTMS) of left dorsolateral prefrontal and temporal cortex according to a protocol that has been shown to yield a significantly higher number of treatment responders than sham stimulation and previous stimulation protocols. Structural magnetic resonance imaging was performed before and after rTMS. In VBM whole-brain analyses (P < 0.05, FWE corrected), we assessed longitudinal gray matter changes as well as structural connectivity between the ensuing regions. We observed longitudinal mesoscopic gray matter changes of left dorsolateral prefontal (DLPFC), left operculo-insular, and right inferior temporal cortex (ITC) in responders (N = 22) but not nonresponders (N = 38), as indicated by a group × time interaction and post-hoc tests. These results were neither influenced by age, sex, hearing loss nor by tinnitus laterality, duration, and severity at baseline. Furthermore, we found robust DLPFC-insula and insula-ITC connectivity in responders, while only relatively weak DLPFC-insula connectivity and no insula-ITC connectivity could be demonstrated in nonresponders. Our results reinforce the implication of nonauditory brain regions in phantom sounds and suggest the dependence of therapeutic response on their neuroplastic capabilities. The latter in turn may depend on (differences in) their individual structural connectivity. Hum Brain Mapp 39:554-562, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Anisotropic diffusion of fluorescently labeled ATP in rat cardiomyocytes determined by raster image correlation spectroscopy

PubMed Central

Vendelin, Marko; Birkedal, Rikke

2008-01-01

A series of experimental data points to the existence of profound diffusion restrictions of ADP/ATP in rat cardiomyocytes. This assumption is required to explain the measurements of kinetics of respiration, sarcoplasmic reticulum loading with calcium, and kinetics of ATP-sensitive potassium channels. To be able to analyze and estimate the role of intracellular diffusion restrictions on bioenergetics, the intracellular diffusion coefficients of metabolites have to be determined. The aim of this work was to develop a practical method for determining diffusion coefficients in anisotropic medium and to estimate the overall diffusion coefficients of fluorescently labeled ATP in rat cardiomyocytes. For that, we have extended raster image correlation spectroscopy (RICS) protocols to be able to discriminate the anisotropy in the diffusion coefficient tensor. Using this extended protocol, we estimated diffusion coefficients of ATP labeled with the fluorescent conjugate Alexa Fluor 647 (Alexa-ATP). In the analysis, we assumed that the diffusion tensor can be described by two values: diffusion coefficient along the myofibril and that across it. The average diffusion coefficients found for Alexa-ATP were as follows: 83 ± 14 μm2/s in the longitudinal and 52 ± 16 μm2/s in the transverse directions (n = 8, mean ± SD). Those values are ∼2 (longitudinal) and ∼3.5 (transverse) times smaller than the diffusion coefficient value estimated for the surrounding solution. Such uneven reduction of average diffusion coefficient leads to anisotropic diffusion in rat cardiomyocytes. Although the source for such anisotropy is uncertain, we speculate that it may be induced by the ordered pattern of intracellular structures in rat cardiomyocytes. PMID:18815224

The influence of physical activity, sedentary behavior on health-related quality of life among the general population of children and adolescents: A systematic review

PubMed Central

Han, Li Hui; Zhang, Jian Hua; Luo, Sheng; Hu, Jin Wei; Sun, Kui

2017-01-01

Background The association between physical activity, sedentary behavior and health-related quality of life in children and adolescents has been mostly investigated in those young people with chronic disease conditions. No systematic review to date has synthesized the relationship between physical activity, sedentary behavior and health-related quality of life in the general healthy population of children and adolescents. The purpose of this study was to review systematically the existing literature that evaluated the relations between physical activity, sedentary behavior and health-related quality of life in the general population of children and adolescents. Methods We conducted a computer search for English language literature from databases of MEDLINE, EMBASE, PSYCINFO and PubMed-related articles as well as the reference lists of existing literature between 1946 and the second week of January 2017 to retrieve eligible studies. We included the studies that assessed associations between physical activity and/or sedentary behavior and health-related quality of life among the general population of children and adolescents aged between 3–18 years. The study design included cross-sectional, longitudinal and health intervention studies. We excluded the studies that examined associations between physical activity, sedentary behavior and health-related quality of life among children and adolescents with specific chronic diseases, and other studies and reports including reviews, meta-analyses, study protocols, comments, letters, case reports and guidelines. We followed up the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement in the reporting of this review. The risk of bias of the primary studies was assessed by the Newcastle-Ottawa Scale. We synthesized the difference in health-related quality of life scores between different levels of physical activity and sedentary time. Results In total, 31 studies met the inclusion criteria and were synthesized in the review. Most of the included studies used a cross-sectional design (n = 21). There were six longitudinal studies and three school-based physical activity intervention studies. One study used both cross-sectional and longitudinal designs. We found that higher levels of physical activity were associated with better health-related quality of life and increased time of sedentary behavior was linked to lower health-related quality of life among children and adolescents. A dose-response relation between physical activity, sedentary behavior and health-related quality of life was observed in several studies suggesting that the higher frequency of physical activity or the less time being sedentary, the better the health-related quality of life. Conclusions The findings in this study suggest that school health programs promoting active lifestyles among children and adolescents may contribute to the improvement of health-related quality of life. Future research is needed to extend studies on longitudinal relationships between physical activity, sedentary behavior and health-related quality of life, and on effects of physical activity interventions on health-related quality of life among children and youth. PMID:29121640

Predicting two-year longitudinal MD Anderson Dysphagia Inventory outcomes after intensity modulated radiotherapy for locoregionally advanced oropharyngeal carcinoma.

PubMed

Goepfert, Ryan P; Lewin, Jan S; Barrow, Martha P; Fuller, C David; Lai, Stephen Y; Song, Juhee; Hobbs, Brian P; Gunn, G Brandon; Beadle, Beth M; Rosenthal, David I; Garden, Adam S; Kies, Merrill S; Papadimitrakopoulou, Vali A; Schwartz, David L; Hutcheson, Katherine A

2017-04-01

To determine the factors associated with longitudinal patient-reported dysphagia as measured by the MD Anderson Dysphagia Inventory (MDADI) in locoregionally advanced oropharyngeal carcinoma (OPC) survivors treated with split-field intensity modulated radiotherapy (IMRT). Retrospective patient analysis. A retrospective analysis combined data from three single-institution clinical trials for stage III/IV head and neck carcinoma. According to trial protocols, patients had prospectively collected MDADI at baseline, 6, 12, and 24 months after treatment. OPC patients with baseline and at least one post-treatment MDADI were included. Longitudinal analysis was completed with multivariate linear mixed effects modeling. There were 116 patients who met inclusion criteria. Mean baseline MDADI composite was 88.3, dropping to 73.8 at 6 months, and rising to 78.6 and 83.3 by 12 and 24 months, respectively (compared to baseline, all P < .0001). Tumor stage and smoking status were significant predictors of longitudinal MDADI composite scores. Patients with T1, T2, and T3 tumors had 15.9 (P = .0001), 10.9 (P = .0049), and 7.5 (P = .0615), respectively, higher mean MDADI composite than those with T4 tumors, and current smokers had a 9.4 (P = .0007) lower mean MDADI composite than never smokers. Patients report clinically meaningful dysphagia early after split-field IMRT for locoregionally advanced OPC that remains apparent 6 months after treatment. MDADI scores recover slowly thereafter, but remain depressed at 24 months compared to baseline. Higher tumor stage and smoking status are important markers of patient-reported function through the course of treatment, suggesting these are important groups for heightened surveillance and more intensive interventions to optimize swallowing outcomes. 4 Laryngoscope, 127:842-848, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Electromyographic Activity of the Masseter and Temporal Muscles in Patients With Nonsyndromic Complete Unilateral Cleft Lip and Palate: 2-Stage Versus 1-Stage Palate Repair.

PubMed

Sabbag, Anelise; Denadai, Rafael; Raposo-Amaral, Cesar Augusto; Buzzo, Celso Luiz; Raposo-Amaral, Cassio Eduardo; Nagae, Mirian H

2018-05-14

To assess the electromyographic activity of the masseter and temporal muscles in cleft patients who underwent 1-stage palate repair versus 2-stage palate repair. Thirty-two patients with nonsyndromic complete unilateral cleft lip and palate operated by 2 different protocols for palate repair, 1-stage (group 1, n = 16) versus 2-stage with delayed hard palate closure (group 2, n = 16) were available in the retrospective longitudinal study. Standardized electromyographic records of the masseter and anterior portion of temporal muscles were obtained with 2 repetitions during mastication and rest. No statistically significant (all P > 0.05) differences were observed in the electromyographic data between the groups 1 and 2. There were similar electromyographic activity of masseter and temporal muscles during mastication and at rest after 1- and 2-stage palate closure.

Prevalence of mitral valve regurgitation in 79 asymptomatic Norfolk terriers.

PubMed

Bodegård-Westling, A; Tidholm, A; Häggström, J

2017-04-01

To determine the prevalence of mitral valve regurgitation (MR) in asymptomatic Swedish Norfolk terriers. Seventy-nine privately owned Norfolk terriers. A prospective observational study was conducted where dogs were recruited via the Swedish Norfolk terrier club. All dogs were examined using the same protocol including physical examination and Doppler echocardiography. Fifteen dogs (19%) had a murmur at the time of the examination. A total of 35 dogs (44%) had MR, including 23 dogs (29%) with both MR and tricuspid valve regurgitation and 12 dogs (15%) with MR only, identified on Doppler echocardiography. In addition, 7 dogs (9%) had tricuspid valve regurgitation only. The prevalence of MR increased with increasing age (p < 0.0001). Mitral valve regurgitation is common in asymptomatic Norfolk terriers with and without murmurs and the prevalence increases with age. The impact of MR in this breed on survival remains to be elucidated by a longitudinal study. Copyright © 2017 Elsevier B.V. All rights reserved.

Language Profile in Congenital Hypothyroid Children Receiving Replacement Therapy.

PubMed

Soliman, Hend; Abdel Hady, Aisha Fawzy; Abdel Hamid, Asmaa; Mahmoud, Heba

2016-01-01

The aim of this work was to evaluate receptive and expressive language skills in children with congenital hypothyroidism receiving early hormonal replacement treatment before the age of 3 months and to identify any subtle areas of weaknesses in their language development to check the necessity for future language intervention. The study was conducted on 30 hypothyroid children receiving hormonal replacement. They were subdivided into group I (5-8 years 11 months; 12 cases) and group II (9-12 years 11 months; 18 cases). All patients were subjected to a protocol of assessment applied in the Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU) and evaluation of language skills by the REAL scale. The younger group reached average Arabic language scores, while the older group showed moderate language delay. Early replacement therapy supports language development in young children. However, longitudinal and follow-up studies are required to identify difficulties presenting at older ages that may affect children in the academic settings. © 2016 S. Karger AG, Basel.

Toward an objective measure of functional disability in dysferlinopathy.

PubMed

Woudt, Lisanne; Di Capua, Gabriella A; Krahn, Martin; Castiglioni, Claudia; Hughes, Ricardo; Campero, Mario; Trangulao, Alejandra; González-Hormazábal, Patricio; Godoy-Herrera, Raúl; Lévy, Nicolas; Urtizberea, Jon Andoni; Jara, Lilian; Bevilacqua, Jorge A

2016-01-01

Understanding the natural history of dysferlinopathy is essential to design and quantify novel therapeutic protocols. Our aim in this study was to assess, clinically and functionally, a cohort of patients with dysferlinopathy, using validated scales. Thirty-one patients with genetically confirmed dysferlinopathy were assessed using the motor function measure (MFM), Modified Rankin Scale (MRS), Muscle Research Council (MRC) scale, serum creatine kinase (CK) assessment, baseline spirometry data, and echocardiographic and electrophysiologic studies. MFM and MRC scores showed a significant negative correlation with disease duration and inverse correlation with MRS, but not with onset age, clinical phenotype, or CK levels. Percent forced vital capacity (%FVC) correlated negatively with disease duration and onset age. Eight known pathogenic mutations were identified recurrently, 4 of which accounted for 79% of the total. The results suggest that MFM is a reliable outcome measure that may be useful for longitudinal follow-up in dysferlinopathy. Recurrent mutations suggest a founder effect in the Chilean population. © 2015 Wiley Periodicals, Inc.

Motivational and evolutionary aspects of a physical exercise training program: a longitudinal study

PubMed Central

Rosa, João P. P.; de Souza, Altay A. L.; de Lima, Giscard H. O.; Rodrigues, Dayane F.; de Aquino Lemos, Valdir; da Silva Alves, Eduardo; Tufik, Sergio; de Mello, Marco T.

2015-01-01

Several studies have indicated that motivational level and prior expectations influence one’s commitment to physical activity. Moreover, these aspects are not properly described in terms of proximal (SDT, Self Determination Theory) and distal (evolutionary) explanations in the literature. This paper aims to verify if level of motivation (BREQ-2, Behavioral Regulation in Exercise Questionnaire-2) and expectations regarding regular physical exercise (IMPRAF-54) before starting a 1-year exercise program could determine likelihood of completion. Ninety-four volunteers (53 women) included a completed protocol group (CPG; n = 21) and drop-out group (n = 73). The IMPRAF-54 scale was used to assess six different expectations associated with physical activity, and the BREQ-2 inventory was used to assess the level of motivation in five steps (from amotivation to intrinsic motivation). Both questionnaires were assessed before starting a regular exercise program. The CPG group presented higher sociability and lower pleasure scores according to IMPRAF-54 domains. A logistic regression analysis showed that a one-point increment on sociability score increased the chance of completing the program by 10%, and the same one-point increment on pleasure score reduced the chance of completing the protocol by 16%. ROC curves were also calculated to establish IMPRAF-54 cutoffs for adherence (Sociability – 18.5 points – 81% sensibility/50% specificity) and dropout (Pleasure – 25.5 points – 86% sensibility/20% specificity) of the exercise protocol. Our results indicate that an expectation of social interaction was a positive factor in predicting adherence to exercise. Grounded in SDT and its innate needs (competence, autonomy, relatedness), physical exercise is not an end; it is a means to achieve autonomy and self-cohesion. The association of physical activity with social practices, as occurs in hunter-gathering groups, can engage people to be physically active and can provide better results in adherence exercise programs for the general population. PMID:26042076

Regional fat distribution in adolescent and adult females with anorexia nervosa: A longitudinal study.

PubMed

El Ghoch, Marwan; Milanese, Chiara; Calugi, Simona; Müller, Manfred J; Pourhassan, Maryam; Ruocco, Antonella; Dalle Grave, Riccardo

2015-12-01

No study has yet compared body fat distribution before and after weight restoration in adolescent and adult patients with anorexia nervosa (AN) treated according to the same protocol. The study was set up to measure body fat distribution before and after short-term weight restoration in adolescent and adult patients with AN treated according to the same protocol in a specialist inpatient unit. We recruited 33 consecutive adolescent female patients with AN, and 33 controls matched by age and post-treatment BMI centile, as well as 33 adult female patients with AN, and 33 controls matched by age and post-treatment BMI. Dual-energy X-ray absorptiometry (DXA) was used to assess body composition before and after short-term weight restoration (BMI ≥ 18.5 kg/m²). Compared with controls, both adolescents and adults with AN showed that a greater amount of fat was lost from the extremities than the trunk before weight restoration, and that there was a central adiposity phenotype after short-term weight restoration. There were no significant differences in body fat distribution between adolescents and adults with AN before or after short-term weight restoration. Adolescent and adult females with AN have similar body fat distribution both before and after short-term weight restoration, and show a central adiposity phenotype after short-term weight restoration. The clinical implications of this finding are as yet unknown. Clinical Trials Registry- Regional Fat Distribution in Adolescent Girls and Adults with Anorexia Nervosa (ISRCTN73572502). Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Japanese Study on Stratification, Health, Income, and Neighborhood: Study Protocol and Profiles of Participants

PubMed Central

Takada, Misato; Kondo, Naoki; Hashimoto, Hideki

2014-01-01

Background The Japanese Study on Stratification, Health, Income, and Neighborhood (J-SHINE) aims to clarify the complex associations between social factors and health from an interdisciplinary perspective and to provide a database for use in various health policy evaluations. Methods J-SHINE is an ongoing longitudinal panel study of households of adults aged 25–50 years. The wave 1 survey was carried out in 2010 among adults randomly selected from the resident registry of four urban and suburban municipalities in the greater Tokyo metropolitan area, Japan. In 2011, surveys for the participants’ spouse/partner and child were additionally conducted. The wave 2 survey was conducted in 2012 for the wave 1 participants and will be followed by the wave 2 survey for spouse/partner and child in 2013. Results Wave 1 sample sizes were 4357 for wave 1 participants (valid response rate: 31.3%; cooperation rate: 51.8%), 1873 for spouse/partner (response rate: 61.9%), and 1520 for child (response rate: 67.7%). Wave 2 captured 69.0% of wave 1 participants. Information gathered covered socio-demographics, household economy, self-reported health conditions and healthcare utilization, stress and psychological values, and developmental history. A subpopulation underwent physiological (n = 2468) and biomarker (n = 1205) measurements. Conclusions Longitudinal survey data, including repeated measures of social factors evaluated based on theories and techniques of various disciplines, like J-SHINE, should contribute toward opening a web of causality for society and health, which may have important policy implications for recent global health promotion strategies such as the World Health Organization’s Social Determinants of Health approach and the second round of Japan’s Healthy Japan 21. PMID:24814507

COBRA: A prospective multimodal imaging study of dopamine, brain structure and function, and cognition.

PubMed

Nevalainen, N; Riklund, K; Andersson, M; Axelsson, J; Ögren, M; Lövdén, M; Lindenberger, U; Bäckman, L; Nyberg, L

2015-07-01

Cognitive decline is a characteristic feature of normal human aging. Previous work has demonstrated marked interindividual variability in onset and rate of decline. Such variability has been linked to factors such as maintenance of functional and structural brain integrity, genetics, and lifestyle. Still, few, if any, studies have combined a longitudinal design with repeated multimodal imaging and a comprehensive assessment of cognition as well as genetic and lifestyle factors. The present paper introduces the Cognition, Brain, and Aging (COBRA) study, in which cognitive performance and brain structure and function are measured in a cohort of 181 older adults aged 64 to 68 years at baseline. Participants will be followed longitudinally over a 10-year period, resulting in a total of three equally spaced measurement occasions. The measurement protocol at each occasion comprises a comprehensive set of behavioral and imaging measures. Cognitive performance is evaluated via computerized testing of working memory, episodic memory, perceptual speed, motor speed, implicit sequence learning, and vocabulary. Brain imaging is performed using positron emission tomography with [(11)C]-raclopride to assess dopamine D2/D3 receptor availability. Structural magnetic resonance imaging (MRI) is used for assessment of white and gray-matter integrity and cerebrovascular perfusion, and functional MRI maps brain activation during rest and active task conditions. Lifestyle descriptives are collected, and blood samples are obtained and stored for future evaluation. Here, we present selected results from the baseline assessment along with a discussion of sample characteristics and methodological considerations that determined the design of the study. This article is part of a Special Issue entitled SI: Memory & Aging. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Japanese study on stratification, health, income, and neighborhood: study protocol and profiles of participants.

PubMed

Takada, Misato; Kondo, Naoki; Hashimoto, Hideki

2014-01-01

The Japanese Study on Stratification, Health, Income, and Neighborhood (J-SHINE) aims to clarify the complex associations between social factors and health from an interdisciplinary perspective and to provide a database for use in various health policy evaluations. J-SHINE is an ongoing longitudinal panel study of households of adults aged 25-50 years. The wave 1 survey was carried out in 2010 among adults randomly selected from the resident registry of four urban and suburban municipalities in the greater Tokyo metropolitan area, Japan. In 2011, surveys for the participants' spouse/partner and child were additionally conducted. The wave 2 survey was conducted in 2012 for the wave 1 participants and will be followed by the wave 2 survey for spouse/partner and child in 2013. Wave 1 sample sizes were 4357 for wave 1 participants (valid response rate: 31.3%; cooperation rate: 51.8%), 1873 for spouse/partner (response rate: 61.9%), and 1520 for child (response rate: 67.7%). Wave 2 captured 69.0% of wave 1 participants. Information gathered covered socio-demographics, household economy, self-reported health conditions and healthcare utilization, stress and psychological values, and developmental history. A subpopulation underwent physiological (n = 2468) and biomarker (n = 1205) measurements. Longitudinal survey data, including repeated measures of social factors evaluated based on theories and techniques of various disciplines, like J-SHINE, should contribute toward opening a web of causality for society and health, which may have important policy implications for recent global health promotion strategies such as the World Health Organization's Social Determinants of Health approach and the second round of Japan's Healthy Japan 21.

Further investigation of phenotypes and confounding factors of progressive ratio performance and feeding behavior in the BACHD rat model of Huntington disease

PubMed Central

Clemensson, Laura Emily; Fabry, Benedikt; Riess, Olaf; Nguyen, Huu Phuc

2017-01-01

Huntington disease is an inherited neurodegenerative disorder characterized by motor, cognitive, psychiatric and metabolic symptoms. We recently published a study describing that the BACHD rat model of HD shows an obesity phenotype, which might affect their motivation to perform food-based behavioral tests. Further, we argued that using a food restriction protocol based on matching BACHD and wild type rats’ food consumption rates might resolve these motivational differences. In the current study, we followed up on these ideas in a longitudinal study of the rats’ performance in a progressive ratio test. We also investigated the phenotype of reduced food consumption rate, which is typically seen in food-restricted BACHD rats, in greater detail. In line with our previous study, the BACHD rats were less motivated to perform the progressive ratio test compared to their wild type littermates, although the phenotype was no longer present when the rats’ food consumption rates had been matched. However, video analysis of food consumption tests suggested that the reduced consumption rate found in the BACHD rats was not entirely based on differences in hunger, but likely involved motoric impairments. Thus, restriction protocols based on food consumption rates are not appropriate when working with BACHD rats. As an alternative, we suggest that studies where BACHD rats are used should investigate how the readouts of interest are affected by motivational differences, and use appropriate control tests to avoid misleading results. In addition, we show that BACHD rats display distinct behavioral changes in their progressive ratio performance, which might be indicative of striatal dysfunction. PMID:28273120

HIV Futures 8: Protocol for a Repeated Cross-sectional and Longitudinal Survey of People Living with HIV in Australia.

PubMed

Power, Jennifer; Brown, Graham; Lyons, Anthony; Thorpe, Rachel; Dowsett, Gary W; Lucke, Jayne

2017-01-01

More than 27,000 Australians currently live with HIV. Most of these people have access to quality clinical care and antiretroviral treatment (ART) and can expect good general health. However, HIV-related stigma is a problem and many people living with HIV experience poorer than average mental health. Issues of aging are also of increasing concern. This paper describes the methods and sample for the HIV Futures 8 study, a national survey of people living with HIV in Australia that aimed to identify factors that support health and well-being among this population. HIV Futures 8 forms part of a series of cross-sectional surveys (The "HIV Futures" studies) that have been repeated periodically since 1997. In the most recent survey, participants were able to opt into a prospective longitudinal study. HIV Futures 8 was open to people aged over 17 who were living with HIV. Data were collected in 2015/2016 using a self-complete survey that contained approximately 250 items related to physical and mental health, use of ART, HIV exposure and testing, financial security, social connectedness, relationships, life satisfaction, resilience, stigma, use of health and support services, and health literacy. To enable comparison of cross-sectional data over time, questionnaire items were consistent with those used in previous HIV Futures surveys. In HIV Futures 8, participants were invited to volunteer coded information that will allow longitudinal follow-up when participants complete subsequent HIV Futures surveys. The survey was advertised through the networks of HIV organizations, on social media and through HIV clinics and services. HIV Futures 8 was completed by 895 participants. This represents approximately 3.8% of the total number of people living with diagnosed HIV in Australia in 2014. Findings from HIV Futures 8 will contribute important insights into the complexity of factors that support physical and mental well-being among people living with HIV. The findings will also assist HIV services to align with broader public health goals related to increasing ART use and improving quality of life among people living with HIV.

Performing piety in sexual health research: gender, health and evangelical Christianities in a Mexican human papillomavirus (HPV) study.

PubMed

Wentzell, Emily

2017-12-01

Recent research suggests that health surveillance experiences like clinical trial participation might have unanticipated social consequences. I investigate how evangelical Christians participating in longitudinal, observational sexual health research incorporate that long-term medical surveillance into their religious practice. This exploratory research focuses on Mexican Cristianos' participation in the Cuernavaca arm of the multinational 'Human Papillomavirus in Men' ('HIM') study, which tested men for the common and usually asymptomatic sexually transmitted infection human papillomavirus (HPV) over time. I draw on interviews with heterosexual male research participants and their female partners throughout their medical research involvement, and data from church-based participant observation, to understand how couples framed the HIM study as an arena for performing piety. I argue that evangelical understandings of piety as moral practice encouraged participants to view long-term sexual health surveillance as assistance for living out the health, gender, and marital behaviors promoted by their congregations. This finding suggests that health research designers and ethics committees should consider the health and social outcomes of research participants' agentive incorporation of religious observance into study protocols.

Using and interpreting mental health measures in the National Social Life, Health, and Aging Project.

PubMed

Payne, Carolyn; Hedberg, E C; Kozloski, Michael; Dale, William; McClintock, Martha K

2014-11-01

National Social Life, Health, and Aging Project (NSHAP) included five unique mental health measures in Waves 1 and 2 that researchers can use to measure the overall emotional health of participants: depressive symptoms, happiness-unhappiness, anxiety symptoms, perceived stress, and felt loneliness. For each, we detail the rationale for its development and explain how to score, analyze, and interpret results. NSHAP developed its measures by modifying traditional short-form scales to improve response efficiency and reduce respondent burden. Scoring protocols and interpretations were developed for each measure. U.S. population estimates for older adults born between 1920 and 1947 were generated using age-eligible samples from Waves 1 and 2. NSHAP's protocols yielded U.S. prevalence rates similar to other nationally representative studies of older adults and comparable between waves. Higher estimates of anxiety symptoms and perceived stress in Wave 2 compared with Wave 1 were explained by age, administration mode, and time period. Analytic strategies for longitudinal analyses are provided. In Wave 2, mental health generally was worse at older ages, with women having more symptoms at younger ages than men. Women had fewer anxiety symptoms at the oldest ages. NSHAP's mental health measures were successfully integrated into the project's survey and showed acceptable external reliability as well as moderately stable individual characteristics across the 5 years between Waves 1 and 2. Depressive symptoms and unhappiness may form a mental health cluster in the elderly, distinct from anxiety symptoms, perceived stress, and felt loneliness. Gender differences in age-specific patterns of mental health were evident using the exact age of participants rather than the traditional decade groupings. Administration mode and time period (between 2005-2006 and 2010-2011) were determined to be potential confounds that need to be accommodated in longitudinal analyses of aging, whereas sample composition was not an issue for interpreting mental health measures. © The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Academic Performance of Language-Minority Students and All-Day Kindergarten: A Longitudinal Study

ERIC Educational Resources Information Center

Chang, Mido

2012-01-01

This longitudinal study examined the effect of all-day kindergarten programs on the academic achievement of students from racial language minority and low socioeconomic class. The study employed a series of 3-level longitudinal multilevel analyses using a nationally representative database, the Early Childhood Longitudinal Study (ECLS). The study…

Functional change in the pattern of swallowing through the performance of orofacial exercises.

PubMed

Alves, Irina Claudia Fernandes; Andrade, Claudia Regina Furquim de

2017-05-22

The objective was to determine if there was functional improvement of swallowing pattern in subjects identified with risk of oropharyngeal dysphagia after four weeks of specific oropharyngeal exercises. These exercises have pre-determined intensity and duration. It is a longitudinal study of functional effect, determined by initial and final comparative measures. Participants were adults and elderly, selected in a period of 24 months. A total of 68 participants were included. All subjects had a clinical evaluation of swallowing, and an initial measure in a functional scale. The individuals were split into two groups, according to the initial levelling of ASHA NOMS scale. In Group 1 (G1) - ASHA NOMS, initial of levels 1 and 2; Group 2 (G2) - ASHA NOMS, initial of levels 3, 4 and 5. All subjects executed an exercise protocol performed for four weeks. The protocol includes sessions with a speech therapist, and continuity of activities in home environment. Finally, new measurement of swallowing performance was held. For G2 group there was statistically significant improvement. For G1, the relation was insignificant, despite the intense change in ASHA NOMS scale, however, in this group there was a reduced number of individuals due to the profile severity. The program was effective because after four exercise sessions, there was significant improvement in swallowing pattern, demonstrated by functional scale.

An in vitro evaluation of various irrigation techniques for the removal of double antibiotic paste from root canal surfaces

PubMed Central

GOKTURK, Hakan; OZKOCAK, Ismail; BUYUKGEBİZ, Fevzi; DEMİR, Osman

2016-01-01

ABSTRACT Objective The aim of this study was to investigate the effectiveness of conventional syringe irrigations, passive ultrasonic irrigation (PUI), Vibringe, CanalBrush, XP-endo Finisher, and laser-activated irrigation (LAI) systems in removing double antibiotic paste (DAP) from root canals. Material and Methods One hundred five extracted single-rooted teeth were instrumented. The roots were split longitudinally. Three standard grooves were created and covered with DAP. The roots were distributed into seven groups: Group 1, beveled needle irrigation; Group 2, double side-vented needle irrigation; Group 3, CanalBrush; Group 4, XP-endo Finisher; Group 5, Vibringe; Group 6, PUI; Group 7, LAI. The amount of remaining DAP was scored under a stereomicroscope. Results Group 4, Group 6, and Group 7 removed significantly more DAP than the other protocols in the coronal region. Group 7 was more efficient in the middle region; however, no significant difference was found between Group 7 and Group 6. No differences were found between groups in the apical region either, except for the comparisons between groups 7 and 2, and groups 2 and 3. Conclusions None of the investigated protocols were able to completely remove the DAP from the grooves. The Vibringe and XP-endo Finisher systems showed results similar to those of conventional needle irrigation. PMID:28076461

Ultrasound and anatomical assessment of the infraspinatus tendon through anterosuperolateral approach.

PubMed

Michelin, Paul; Kasprzak, Kevin; Dacher, Jean Nicolas; Lefebvre, Valentin; Duparc, Fabrice

2015-08-01

In the literature, shoulder ultrasound (US) protocols rely on the widely accepted anatomical concept of the infraspinatus tendon (IST) running parallel and posterior to the supraspinatus tendon (SST). To assess the IST, authors currently recommend placing the transducer posteroinferior to the acromion; however the examination of the anterosuperior part of the IST remains problematic. The aim of our study was to apply recent anatomical knowledge to propose a simple protocol to assess the IST over its entire width including its anterosuperior margin. Six non-diseased shoulders from four cadavers were assessed in hyperextended internal rotation (HIR) position with US anterosuperolateral approach followed by dissection. Twelve healthy volunteers underwent similar US examination of the shoulder. The IST is a thin, wide, strap-like tendon. The HIR position exposed the largest area of IST beyond the acromion; combined anterosuperolateral US approach enabled imaging of the IST over its entire width with transverse and longitudinal views. The anterosuperior margin of the IST was distinguishable from the SST. The anterosuperolateral US approach in HIR position enables an accurate assessment of the IST including the transverse plane. The limit between the SST and IST appears more clearly. • The hyperextended internal rotation of the shoulder brings the infraspinatus tendon forward. • The infraspinatus tendon is visible with anterosuperolateral ultrasound approach. • The anterosuperior margin of the infraspinatus tendon is visible with this technique.

Cardiac parasympathetic regulation in obese women with binge eating disorder.

PubMed

Friederich, H-C; Schild, S; Schellberg, D; Quenter, A; Bode, C; Herzog, W; Zipfel, S

2006-03-01

Obese individuals with a binge eating disorder (BED) differ from obese non-binge eaters (NBED) with respect to (a) eating behaviour, (b) psychiatric comorbidity and (c) level of psychosocial distress. The aim of the study was to explore whether these three factors have an influence on cardiac parasympathetic function, that is independent of obesity: as alterations in cardiac parasympathetic function may have a role in the higher cardiovascular mortality that is present in obese individuals. In total, 38 obese women (BMI>30 kg/m(2)), with a BED and 34 age and BMI matched healthy controls (NBED) completed a laboratory stress protocol that incorporated a baseline resting period, Head-up Tilt Testing (HUT) and two challenging mental tasks. Heart rate and blood pressure were measured continuously during the protocol. Parasympathetic cardiac regulation was assessed as the high frequency component of heart rate variability (HRV-HF). Mental challenge led to an augmented reduction of HRV-HF in obese binge eaters, which was linked to the binge eating frequency and hunger perception, but not to psychiatric comorbidity. During baseline conditions and HUT, no significant differences in parasympathetic measures were observed between the two subject groups. Subjects with a BED showed greater reduction in parasympathetic cardiac control (HRV-HF) during mental stress, suggesting higher stress vulnerability in women with a BED. Longitudinal investigations are necessary to evaluate whether this is associated with an increased cardiovascular mortality.

Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer.

PubMed

Sundar, Sudha; Rick, Caroline; Dowling, Francis; Au, Pui; Snell, Kym; Rai, Nirmala; Champaneria, Rita; Stobart, Hilary; Neal, Richard; Davenport, Clare; Mallett, Susan; Sutton, Andrew; Kehoe, Sean; Timmerman, Dirk; Bourne, Tom; Van Calster, Ben; Gentry-Maharaj, Aleksandra; Menon, Usha; Deeks, Jon

2016-08-09

Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III). ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios. 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/

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients’ associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Methods/design Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients’ associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. Discussion The first data gathered have allowed us to identify the characteristics of the study population and they support the appropriateness of the inclusion criteria.. When the study is complete, the results will enable us to establish whether this kind of intervention can be used as a self-regulation tool for increasing and maintaining walking as unsupervised physical exercise of low to moderate intensity in fibromyalgia patients. Trial registration Trial registration number: ISRCTN68584893 PMID:24721143

Assessment of the radioanatomic positioning of the osteoarthritic knee in serial radiographs: comparison of three acquisition techniques.

PubMed

Le Graverand, M-P H; Mazzuca, S; Lassere, M; Guermazi, A; Pickering, E; Brandt, K; Peterfy, C; Cline, G; Nevitt, M; Woodworth, T; Conaghan, P; Vignon, E

2006-01-01

Recent studies using various standardized radiographic acquisition techniques have demonstrated the necessity of reproducible radioanatomic alignment of the knee to assure precise measurements of medial tibiofemoral joint space width (JSW). The objective of the present study was to characterize the longitudinal performance of several acquisition techniques with respect to long-term reproducibility of positioning of the knee, and the impact of changes in positioning on the rate and variability of joint space narrowing (JSN). Eighty subjects were randomly selected from each of three cohorts followed in recent studies of the radiographic progression of knee osteoarthritis (OA): the Health ABC study (paired fixed-flexion [FF] radiographs taken at a 36-month interval); the Glucosamine Arthritis Intervention Trial (GAIT) (paired metatarsophalangeal [MTP] radiographs obtained at a 12-month interval), and a randomized clinical trial of doxycycline (fluoroscopically assisted semiflexed anteroposterior (AP) radiographs taken at a 16-month interval). Manual measurements were obtained from each radiograph to represent markers of radioanatomic positioning of the knee (alignment of the medial tibial plateau and X-ray beam, knee rotation, femorotibial angle) and to evaluate minimum JSW (mJSW) in the medial tibiofemoral compartment. The effects on the mean annualized rate of JSN and on the variability of that rate of highly reproduced vs variable positioning of the knee in serial radiographs were evaluated. Parallel or near-parallel alignment was achieved significantly more frequently with the fluoroscopically guided positioning used in the semiflexed AP protocol than with either the non-fluoroscopic FF or MTP protocol (68% vs 14% for both FF and MTP protocols when measured at the midpoint of the medial compartment; 75% vs 26% and 34% for the FF and MTP protocols, respectively, when measured at the site of mJSW; P<0.001 for each). Knee rotation was reproduced more frequently in semiflexed AP radiographs than in FF radiographs (66% vs 45%, P<0.01). In contrast, the FF technique yielded a greater proportion of paired radiographs in which the femorotibial angle was accurately reproduced than the semiflexed AP or MTP protocol (78% vs 59% and 56%, respectively, P<0.01 for each). Notably, only paired radiographs with parallel or near-parallel alignment exhibited a mean rate of JSN (+/-SD) in the OA knee that was more rapid and less variable than that measured in all knees (0.186+/-0.274 mm/year, standardized response to mean [SRM]=0.68 vs 0.128+/-0.291 mm/year, SRM=0.44). This study confirms the importance of parallel radioanatomic alignment of the anterior and posterior margins of the medial tibial plateau in detecting JSN in subjects with knee OA. The use of radiographic methods that assure parallel alignment during serial X-ray examinations will permit the design of more efficient studies of biomarkers of OA progression and of structure modification in knee OA.

Tracking Temperature-Dependent Relaxation Times of Ferritin Nanomagnets with a Wideband Quantum Spectrometer

NASA Astrophysics Data System (ADS)

Schäfer-Nolte, Eike; Schlipf, Lukas; Ternes, Markus; Reinhard, Friedemann; Kern, Klaus; Wrachtrup, Jörg

2014-11-01

We demonstrate the tracking of the spin dynamics of ensemble and individual magnetic ferritin proteins from cryogenic up to room temperature using the nitrogen-vacancy color center in diamond as a magnetic sensor. We employ different detection protocols to probe the influence of the ferritin nanomagnets on the longitudinal and transverse relaxation of the nitrogen-vacancy center, which enables magnetic sensing over a wide frequency range from Hz to GHz. The temperature dependence of the observed spectral features can be well understood by the thermally induced magnetization reversals of the ferritin and enables the determination of the anisotropy barrier of single ferritin molecules.

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

Tsalafoutas, Ioannis A.; Varsamidis, Athanasios; Thalassinou, Stella

Purpose: To investigate the utility of the nested polymethylacrylate (PMMA) phantom (which is available in many CT facilities for CTDI measurements), as a tool for the presentation and comparison of the ways that two different CT automatic exposure control (AEC) systems respond to a phantom when various scan parameters and AEC protocols are modified.Methods: By offsetting the two phantom's components (the head phantom and the body ring) half-way along their longitudinal axis, a phantom with three sections of different x-ray attenuation was created. Scan projection radiographs (SPRs) and helical scans of the three-section phantom were performed on a Toshiba Aquilionmore » 64 and a Philips Brilliance 64 CT scanners, with different scan parameter selections [scan direction, pitch factor, slice thickness, and reconstruction interval (ST/RI), AEC protocol, and tube potential used for the SPRs]. The dose length product (DLP) values of each scan were recorded and the tube current (mA) values of the reconstructed CT images were plotted against the respective Z-axis positions on the phantom. Furthermore, measurements of the noise levels at the center of each phantom section were performed to assess the impact of mA modulation on image quality.Results: The mA modulation patterns of the two CT scanners were very dissimilar. The mA variations were more pronounced for Aquilion 64, where changes in any of the aforementioned scan parameters affected both the mA modulations curves and DLP values. However, the noise levels were affected only by changes in pitch, ST/RI, and AEC protocol selections. For Brilliance 64, changes in pitch affected the mA modulation curves but not the DLP values, whereas only AEC protocol and SPR tube potential selection variations affected both the mA modulation curves and DLP values. The noise levels increased for smaller ST/RI, larger weight category AEC protocol, and larger SPR tube potential selection.Conclusions: The nested PMMA dosimetry phantom can be effectively utilized for the comprehension of CT AEC systems performance and the way that different scan conditions affect the mA modulation patterns, DLP values, and image noise. However, in depth analysis of the reasons why these two systems exhibited such different behaviors in response to the same phantom requires further investigation which is beyond the scope of this study.« less

Methods of in-vivo mouse lung micro-CT

NASA Astrophysics Data System (ADS)

Recheis, Wolfgang A.; Nixon, Earl; Thiesse, Jacqueline; McLennan, Geoffrey; Ross, Alan; Hoffman, Eric

2005-04-01

Micro-CT will have a profound influence on the accumulation of anatomical and physiological phenotypic changes in natural and transgenetic mouse models. Longitudinal studies will be greatly facilitated, allowing for a more complete and accurate description of events if in-vivo studies are accomplished. The purpose of the ongoing project is to establish a feasible and reproducible setup for in-vivo mouse lung micro-computed tomography (μCT). We seek to use in-vivo respiratory-gated μCT to follow mouse models of lung disease with subsequent recovery of the mouse. Methodologies for optimizing scanning parameters and gating for the in-vivo mouse lung are presented. A Scireq flexiVent ventilated the gas-anesthetized mice at 60 breaths/minute, 30 cm H20 PEEP, 30 ml/kg tidal volume and provided a respiratory signal to gate a Skyscan 1076 μCT. Physiologic monitoring allowed the control of vital functions and quality of anesthesia, e.g. via ECG monitoring. In contrary to longer exposure times with ex-vivo scans, scan times for in-vivo were reduced using 35μm pixel size, 158ms exposure time and 18μm pixel size, 316ms exposure time to reduce motion artifacts. Gating via spontaneous breathing was also tested. Optimal contrast resolution was achieved at 50kVp, 200μA, applying an aluminum filter (0.5mm). There were minimal non-cardiac related motion artifacts. Both 35μm and 1μm voxel size images were suitable for evaluation of the airway lumen and parenchymal density. Total scan times were 30 and 65 minutes respectively. The mice recovered following scanning protocols. In-vivo lung scanning with recovery of the mouse delivered reasonable image quality for longitudinal studies, e.g. mouse asthma models. After examining 10 mice, we conclude μCT is a feasible tool evaluating mouse models of lung pathology in longitudinal studies with increasing anatomic detail available for evaluation as one moves from in-vivo to ex-vivo studies. Further developments include automated bronchial tree segmentation and airway wall thickness measurement tools. Improvements in Hounsfield unit calibration have to be performed when the interest of the study lies in determining and quantifying parenchymal changes and rely on estimating partial volume contributions of underlying structures to voxel densities.

Prevalence, Motivations, and Social, Mental Health and Health Consequences of Cyberbullying Among School-Aged Children and Youth: Protocol of a Longitudinal and Multi-Perspective Mixed Method Study

PubMed Central

McInroy, Lauren B; Lacombe-Duncan, Ashley; Bhole, Payal; Van Wert, Melissa; Schwan, Kaitlin; Birze, Arija; Daciuk, Joanne; Beran, Tanya; Craig, Wendy; Pepler, Debra J; Wiener, Judith; Khoury-Kassabri, Mona; Johnston, David

2016-01-01

Background While the online environment may promote important developmental and social benefits, it also enables the serious and rapidly growing issue of cyberbullying. Cyberbullying constitutes an increasing public health problem – victimized children and youth experience a range of health and mental health concerns, including emotional and psychosomatic problems, maladaptive behaviors, and increased suicidality. Perpetrators demonstrate a lack of empathy, and may also struggle with health and mental health issues. Objective This paper describes the protocols applied in a longitudinal and multi-perspective mixed-methods study with five objectives: (1) to explore children/youth’s experiences, and children/youth’s, parents’, and teachers’ conceptions, definitions, and understanding of cyberbullying; (2) to explore how children/youth view the underlying motivations for cyberbullying; (3) to document the shifting prevalence rates of cyberbullying victimization, witnessing, and perpetration; (4) to identify risk and protective factors for cyberbullying involvement; and (5) to explore social, mental health, and health consequences of cyberbullying. Methods Quantitative survey data were collected over three years (2012-2014) from a stratified random baseline sample of fourth (n=160), seventh (n=243), and tenth (n=267) grade children/youth, their parents (n=246), and their teachers (n=103). Quantitative data were collected from students and teachers during in-person school visits, and from parents via mail-in surveys. Student, parent, and teacher surveys included questions regarding: student experiences with bullying/cyberbullying; student health, mental health, and social and behavioral issues; socio-demographics; and information and communication technology use. In-depth semi-structured qualitative interviews were conducted twice with a sub-sample of students (n=57), purposively selected based on socio-demographics and cyberbullying experience, twice with their parents (n=50), and once with their teachers (n=30). Results Data collection for this study is complete. Planned analyses include transition probabilities and repeated measures analyses to determine involvement in cyberbullying. Repeated measures analyses, including between-subject factors (eg, socio-demographics), will be utilized to determine factors that protect or increase risk of involvement in cyberbullying. Qualitative analysis utilizing grounded theory is planned, to permit rich understanding of participant experiences and perspectives. Results will be reported in 2016 and 2017. Conclusions This study will offer insight into the contemporary phenomenon of cyberbullying while also informing interventions to curb cyberbullying and address its pervasive social, mental health, and health consequences. Knowledge mobilization strategies and implications for research and practice are discussed. PMID:27220556

77 FR 39344 - Agency Information (Post-9/11 GI Bill Education Longitudinal Study Survey) Activity Under OMB Review

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-02

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-New (Post-9/11 GI Bill Longitudinal Study Survey)] Agency Information (Post-9/11 GI Bill Education Longitudinal Study Survey) Activity Under OMB...-9/11 GI Bill Longitudinal Study Survey) in any correspondence For Further Information or a Copy of...

Attrition and retention in upper limb prosthetics research: experience of the VA home study of the DEKA arm.

PubMed

Resnik, Linda; Klinger, Shana

2017-11-01

(1) Describe study attrition; (2) identify reasons for attrition, and (3) discuss implications for prosthetic prescription and design of future device studies. Design and methodological procedures used: Completion phase (during in-laboratory training, after training, or home use) was identified for 42 participants. Qualitative data were analyzed to identify attrition reasons. Reasons were classified as related to the DEKA arm, or not. Study attrition was 57%, with 43% completing the full study. Attrition during the in-laboratory portion was 21%. Reasons for attrition were related to the DEKA arm entirely or in-part for 42%, 25%, respectively. Most common reasons were scheduling/personal (54%); device weight (29%); and dissatisfaction with device (25%). About 21% withdrew because of concerns about compliance with study protocol. This study had a high attrition rate with evidence of selective attrition due to device characteristics. Strategies to minimize attrition and the importance of tracking reasons for withdrawal are discussed. Given that retention could be an indicator of willingness to adopt the DEKA arm, findings suggest that it would be prudent to provide patients with the opportunity to train with the DEKA arm before a decision is made regarding the appropriateness of the device for the patient. Implications for Rehabilitation This study of a new upper limb prosthesis, the DEKA arm, had a 57% attrition rate with evidence of selective attrition due to characteristics of the DEKA arm. Findings point to the need for strategies to minimize attrition in future studies. Findings also illustrate the importance of tracking reasons for subject withdrawal in longitudinal prosthesis device studies. Because participant retention in longitudinal device studies may be an indicator of future willingness to adopt a device, our findings suggest that it would be prudent to provide patients with the opportunity to train with the DEKA arm before a final decision is made regarding the appropriateness of the device for the patient.

SU-E-I-24: Method for CT Automatic Exposure Control Verification

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

Gracia, M; Olasolo, J; Martin, M

Purpose: Design of a phantom and a simple method for the automatic exposure control (AEC) verification in CT. This verification is included in the computed tomography (CT) Spanish Quality Assurance Protocol. Methods: The phantom design is made from the head and the body phantom used for the CTDI measurement and PMMA plates (35×35 cm2) of 10 cm thickness. Thereby, three different thicknesses along the longitudinal axis are obtained which permit to evaluate the longitudinal AEC performance. Otherwise, the existent asymmetry in the PMMA layers helps to assess angular and 3D AEC operation.Recent acquisition in our hospital (August 2014) of Nomexmore » electrometer (PTW), together with the 10 cm pencil ionization chamber, led to register dose rate as a function of time. Measurements with this chamber fixed at 0° and 90° on the gantry where made on five multidetector-CTs from principal manufacturers. Results: Individual analysis of measurements shows dose rate variation as a function of phantom thickness. The comparative analysis shows that dose rate is kept constant in the head and neck phantom while the PMMA phantom exhibits an abrupt variation between both results, being greater results at 90° as the thickness of the phantom is 3.5 times larger than in the perpendicular direction. Conclusion: Proposed method is simple, quick and reproducible. Results obtained let a qualitative evaluation of the AEC and they are consistent with the expected behavior. A line of future development is to quantitatively study the intensity modulation and parameters of image quality, and a possible comparative study between different manufacturers.« less

Prediction of 30-year risk for cardiovascular mortality by fitness and risk factor levels: the Cooper Center Longitudinal Study.

PubMed

Wickramasinghe, Chanaka D; Ayers, Colby R; Das, Sandeep; de Lemos, James A; Willis, Benjamin L; Berry, Jarett D

2014-07-01

Fitness and traditional risk factors have well-known associations with cardiovascular disease (CVD) death in both short-term (10 years) and across the remaining lifespan. However, currently available short-term and long-term risk prediction tools do not incorporate measured fitness. We included 16 533 participants from the Cooper Center Longitudinal Study (CCLS) without prior CVD. Fitness was measured using the Balke protocol. Sex-specific fitness levels were derived from the Balke treadmill times and categorized into low, intermediate, and high fit according to age- and sex-specific treadmill times. Sex-specific 30-year risk estimates for CVD death adjusted for competing risk of non-CVD death were estimated using the cause-specific hazards model and included age, body mass index, systolic blood pressure, fitness, diabetes mellitus, total cholesterol, and smoking. During a median follow-up period of 28 years, there were 1123 CVD deaths. The 30-year risk estimates for CVD mortality derived from the cause-specific hazards model demonstrated overall good calibration (Nam-D'Agostino χ(2) [men, P=0.286; women, P=0.664] and discrimination (c statistic; men, 0.81 [0.80-0.82] and women, 0.86 [0.82-0.91]). Across all risk factor strata, the presence of low fitness was associated with a greater 30-year risk for CVD death. Fitness represents an important additional covariate in 30-year risk prediction functions that may serve as a useful tool in clinical practice. © 2014 American Heart Association, Inc.

Natural Killer (NK) Cell Functionality after human Spinal Cord Injury (SCI): protocol of a prospective, longitudinal study.

PubMed

Laginha, Inês; Kopp, Marcel A; Druschel, Claudia; Schaser, Klaus-Dieter; Brommer, Benedikt; Hellmann, Rick C; Watzlawick, Ralf; Ossami-Saidi, Ramin-Raul; Prüss, Harald; Failli, Vieri; Meisel, Christian; Liebscher, Thomas; Prilipp, Erik; Niedeggen, Andreas; Ekkernkamp, Axel; Grittner, Ulrike; Piper, Sophie K; Dirnagl, Ulrich; Killig, Monica; Romagnani, Chiara; Schwab, Jan M

2016-09-13

Natural killer (NK) cells comprise the main components of lymphocyte-mediated nonspecific immunity. Through their effector function they play a crucial role combating bacterial and viral challenges. They are also thought to be key contributors to the systemic spinal cord injury-induced immune-deficiency syndrome (SCI-IDS). SCI-IDS increases susceptibility to infection and extends to the post-acute and chronic phases after SCI. The prospective study of NK cell function after traumatic SCI was carried out in two centers in Berlin, Germany. SCI patients and control patients with neurologically silent vertebral fracture also undergoing surgical stabilization were enrolled. Furthermore healthy controls were included to provide reference data. The NK cell function was assessed at 7 (5-9) days, 14 days (11-28) days, and 10 (8-12) weeks post-trauma. Clinical documentation included the American Spinal Injury Association (ASIA) impairment scale (AIS), neurological level of injury, infection status, concomitant injury, and medications. The primary endpoint of the study is CD107a expression by NK cells (cytotoxicity marker) 8-12 weeks following SCI. Secondary endpoints are the NK cell's TNF-α and IFN-γ production by the NK cells 8-12 weeks following SCI. The protocol of this study was developed to investigate the hypotheses whether i) SCI impairs NK cell function throughout the post-acute and sub-acute phases after SCI and ii) the degree of impairment relates to lesion height and severity. A deeper understanding of the SCI-IDS is crucial to enable strategies for prevention of infections, which are associated with poor neurological outcome and elevated mortality. DRKS00009855 .

Protocol for the process evaluation of interventions combining performance-based financing with health equity in Burkina Faso.

PubMed

Ridde, Valéry; Turcotte-Tremblay, Anne-Marie; Souares, Aurélia; Lohmann, Julia; Zombré, David; Koulidiati, Jean Louis; Yaogo, Maurice; Hien, Hervé; Hunt, Matthew; Zongo, Sylvie; De Allegri, Manuela

2014-10-12

The low quality of healthcare and the presence of user fees in Burkina Faso contribute to low utilization of healthcare and elevated levels of mortality. To improve access to high-quality healthcare and equity, national authorities are testing different intervention arms that combine performance-based financing with community-based health insurance and pro-poor targeting. There is a need to evaluate the implementation of these unique approaches. We developed a research protocol to analyze the conditions that led to the emergence of these intervention arms, the fidelity between the activities initially planned and those conducted, the implementation and adaptation processes, the sustainability of the interventions, the possibilities for scaling them up, and their ethical implications. The study adopts a longitudinal multiple case study design with several embedded levels of analyses. To represent the diversity of contexts where the intervention arms are carried out, we will select three districts. Within districts, we will select both primary healthcare centers (n =18) representing different intervention arms and the district or regional hospital (n =3). We will select contrasted cases in relation to their initial performance (good, fair, poor). Over a period of 18 months, we will use quantitative and qualitative data collection and analytical tools to study these cases including in-depth interviews, participatory observation, research diaries, and questionnaires. We will give more weight to qualitative methods compared to quantitative methods. Performance-based financing is expanding rapidly across low- and middle-income countries. The results of this study will enable researchers and decision makers to gain a better understanding of the factors that can influence the implementation and the sustainability of complex interventions aiming to increase healthcare quality as well as equity.

Tailored Panel Management: A Theory-Based Approach to Building and Maintaining Participant Commitment to a Longitudinal Study.

PubMed

Estrada, Mica; Woodcock, Anna; Schultz, P Wesley

2014-02-01

Many psychological processes unfold over time, necessitating longitudinal research designs. Longitudinal research poses a host of methodological challenges, foremost of which is participant attrition. Building on Dillman's work, we provide a review of how social influence and relationship research informs retention strategies in longitudinal studies. Objective: We introduce the tailored panel management (TPM) approach, which is designed to establish communal norms that increase commitment to a longitudinal study, and this commitment, in turn, increases response rates and buffers against attrition. Specifically, we discuss practices regarding compensation, communication, consistency, and credibility that increase longer term commitment to panel participation. Research design: Throughout the article, we describe how TPM is being used in a national longitudinal study of undergraduate minority science students. TheScienceStudy is a continuing panel, which has 12 waves of data collected across 6 academic years, with response rates ranging from 70% to 92%. Although more than 90% of participants have either left or graduated from their undergraduate degree program, this highly mobile group of people remains engaged in the study. TheScienceStudy has usable longitudinal data from 96% of the original panel. Conclusion: This article combines social psychological theory, current best practice, and a detailed case study to illustrate the TPM approach to longitudinal data collection. The approach provides guidance for other longitudinal researchers, and advocates for empirical research into longitudinal research methodologies. © The Author(s) 2014.

Protocol for the Northern babies longitudinal study: predicting postpartum depression and improving parent–infant interaction with The Newborn Behavioral Observation

PubMed Central

Høifødt, Ragnhild Sørensen; Nordahl, Dag; Pfuhl, Gerit; Landsem, Inger Pauline; Thimm, Jens C; Ilstad, Linn Kathrin K; Wang, Catharina Elisabeth Arfwedson

2017-01-01

Introduction Postpartum depression (PPD) is a prevalent disorder. Studying the factors related to PPD will help to identify families at risk and provide preventive interventions. This can in turn improve the developmental trajectories for the children. Several previous studies have investigated risk factors for PPD. However, few studies have focused on cognitive vulnerability factors. The first aim of the present study is to explore a range of protective and risk factors, including cognitive factors, for PPD, parent–infant interactions and child development. The second aim of the study is to evaluate the effectiveness of The Newborn Behavioral Observation (NBO) as a universal preventive intervention delivered in routine practice. The NBO is a brief relationship-enhancing intervention that may reduce depressive symptomatology in mothers. Methods The study is a longitudinal observational study with an intervention. The observational study uses a prospective cohort design, whereas the intervention study has a non-randomised cluster-controlled design comparing a group receiving NBO with a group receiving standard care. The intervention group will receive three NBO sessions within the first 4 weeks postdelivery. Between 2015 and 2018, approximately 200 families will be recruited in the municipality of Tromsø, Norway. Parents are recruited during pregnancy, and assessments will be performed during gestational weeks 16–22, 24–30 and 31, and at 6 weeks, 4 months and 6 months postdelivery. Predictor variables include several cognitive vulnerability factors including early maladaptive schemas, implicit attitudes and cognitive processing of emotionally valenced infant facial information. Ethics and dissemination The Regional Committee for Medical and Health Research Ethics in Northern Norway has approved the project. The research team has collaboration with local health services and can assist participants who need more extensive follow-up. Results from the project will be disseminated in international and national peer-reviewed journals, and at courses and conferences. Trials registration number NCT02538497; Pre-results. PMID:28963284

Normalization of mass cytometry data with bead standards

PubMed Central

Finck, Rachel; Simonds, Erin F.; Jager, Astraea; Krishnaswamy, Smita; Sachs, Karen; Fantl, Wendy; Pe’er, Dana; Nolan, Garry P.; Bendall, Sean C.

2013-01-01

Mass cytometry uses atomic mass spectrometry combined with isotopically pure reporter elements to currently measure as many as 40 parameters per single cell. As with any quantitative technology, there is a fundamental need for quality assurance and normalization protocols. In the case of mass cytometry, the signal variation over time due to changes in instrument performance combined with intervals between scheduled maintenance must be accounted for and then normalized. Here, samples were mixed with polystyrene beads embedded with metal lanthanides, allowing monitoring of mass cytometry instrument performance over multiple days of data acquisition. The protocol described here includes simultaneous measurements of beads and cells on the mass cytometer, subsequent extraction of the bead-based signature, and the application of an algorithm enabling correction of both short- and long-term signal fluctuations. The variation in the intensity of the beads that remains after normalization may also be used to determine data quality. Application of the algorithm to a one-month longitudinal analysis of a human peripheral blood sample reduced the range of median signal fluctuation from 4.9-fold to 1.3-fold. PMID:23512433

Optical Cross-Sectional Muscle Area Determination of Drosophila Melanogaster Adult Indirect Flight Muscles.

PubMed

Selma-Soriano, Estela; Artero, Rubén; Llamusi, Beatriz

2018-03-31

Muscle mass wasting, known as muscle atrophy, is a common phenotype in Drosophila models of neuromuscular diseases. We have used the indirect flight muscles (IFMs) of flies, specifically the dorso-longitudinal muscles (DLM), as the experimental subject to measure the atrophic phenotype brought about by different genetic causes. In this protocol, we describe how to embed fly thorax muscles for semi thin sectioning, how to obtain a good contrast between muscle and the surrounding tissue, and how to process optical microscope images for semiautomatic acquisition of quantifiable data and analysis. We describe three specific applications of the methodological pipeline. First, we show how the method can be applied to quantify muscle degeneration in a myotonic dystrophy fly model; second, measurement of muscle cross-sectional area can help to identify genes that either promote or prevent muscle atrophy and/or muscle degeneration; third, this protocol can be applied to determine whether a candidate compound is able to significantly modify a given atrophic phenotype induced by a disease-causing mutation or by an environmental trigger.

Factors Affecting the Implementation of Argument in the Elementary Science Classroom. A Longitudinal Case Study

NASA Astrophysics Data System (ADS)

Martin, Anita M.; Hand, Brian

2009-01-01

This longitudinal case study describes the factors that affect an experienced teacher’s attempt to shift her pedagogical practices in order to implement embedded elements of argument into her science classroom. Research data was accumulated over 2 years through video recordings of science classes. The Reformed Teacher Observation Protocol (RTOP) is an instrument designed to quantify changes in classroom environments as related to reform as defined by the National Research Council ( National science education standards. Washington, DC: National Academy Press, 1996b) and the National Research Council ( Fulfilling the promise: Biology education in the nation’s schools, Washington, DC: National Academy Press, 1990) and was used to analyze videotaped science lessons. Analysis of the data shows that there was a significant shift in the areas of teacher questioning, and student voice. Several levels of subsequent analysis were completed related to teacher questioning and student voice. The data suggests a relationship between these areas and the implementation of scientific argument. Results indicate that the teacher moved from a traditional, teacher-centered, didactic teaching style to instructional practices that allowed the focus and direction of the lesson to be affected by student voice. This was accomplished by a change in teacher questioning that included a shift from factual recall to more divergent questioning patterns allowing for increased student voice. As student voice increased, students began to investigate ideas, make statements or claims and to support these claims with strong evidence. Finally, students were observed refuting claims in the form of rebuttals. This study informs professional development related to experienced teachers in that it highlights pedagogical issues involved in implementing embedded elements of argument in the elementary classroom.

Longitudinal Changes in Visual Acuity and Health Related Quality of Life. The Los Angeles Latino Eye Study

PubMed Central

McKean-Cowdin, Roberta; Varma, Rohit; Hays, Ron D.; Wu, Joanne; Choudhury, Farzana; Azen, Stanley P.

2010-01-01

Purpose To examine the association between longitudinal changes in visual acuity (VA) and Health Related Quality of Life (HRQOL) in a population-based sample of adult Latinos. Design A population-based cohort study of eye disease in Latinos. Participants 3,169 adult Latino participants who live in the city of La Puente, California. Methods Data for these analyses were collected for the Los Angeles Latino Eye Study (LALES). Distance visual acuity (VA) was measured during a detailed ophthalmologic examination using the standard Early Treatment Diabetic Retinopathy Study protocol at baseline and a 4 year follow-up examination. HRQOL was assessed by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and the Medical Outcomes Study 12-Item Short-Form Health Survey version 1 (SF-12 v.1). Main Outcome Measures Mean differences in HRQOL composite and subscale scores between baseline and follow-up were calculated for 3,169 participants with complete clinical examination and HRQOL data at both time points. Mean differences and effect sizes (ES) for NEI-VFQ and SF-12 v.1 scores were calculated for 3 categories of VA change over the 4 year follow-up period (VA improved ≥ 2 lines, no change in VA or −2

An assessment of US microbiome research.

PubMed

Stulberg, Elizabeth; Fravel, Deborah; Proctor, Lita M; Murray, David M; LoTempio, Jonathan; Chrisey, Linda; Garland, Jay; Goodwin, Kelly; Graber, Joseph; Harris, M Camille; Jackson, Scott; Mishkind, Michael; Porterfield, D Marshall; Records, Angela

2016-01-11

Genome-enabled technologies have supported a dramatic increase in our ability to study microbial communities in environments and hosts. Taking stock of previously funded microbiome research can help to identify common themes, under-represented areas and research priorities to consider moving forward. To assess the status of US microbiome research, a team of government scientists conducted an analysis of federally funded microbiome research. Microbiomes were defined as host-, ecosystem- or habitat-associated communities of microorganisms, and microbiome research was defined as those studies that emphasize community-level analyses using 'omics technologies. Single pathogen, single strain and culture-based studies were not included, except symbiosis studies that served as models for more complex communities. Fourteen governmental organizations participated in the data call. The analysis examined three broad research themes, eight environments and eight microbial categories. Human microbiome research was larger than any other environment studied, and the basic biology research theme accounted for half of the total research activities. Computational biology and bioinformatics, reference databases and biorepositories, standardized protocols and high-throughput tools were commonly identified needs. Longitudinal and functional studies and interdisciplinary research were also identified as needs. This study has implications for the funding of future microbiome research, not only in the United States but beyond.

Myocardial strain in healthy adults across a broad age range as revealed by cardiac magnetic resonance imaging at 1.5 and 3.0T: Associations of myocardial strain with myocardial region, age, and sex.

PubMed

Mangion, Kenneth; Clerfond, Guillaume; McComb, Christie; Carrick, David; Rauhalammi, Samuli M; McClure, John; Corcoran, David S; Woodward, Rosemary; Orchard, Vanessa; Radjenovic, Aleksandra; Zhong, Xiaodong; Berry, Colin

2016-11-01

To assess myocardial strain using cine displacement encoding with stimulated echoes (DENSE) using 1.5T and 3.0T MRI in healthy adults. Healthy adults without any history of cardiovascular disease underwent magnetic resonance imaging (MRI) at 1.5T and 3.0T within 2 days. The MRI protocol included balanced steady-state free-precession (b-SSFP), 2D cine-echo planar imaging (EPI)-DENSE, and late gadolinium enhancement in subjects >45 years. Acquisitions were divided into six segments; global and segmental peak longitudinal and circumferential strain were derived and analyzed by field strength, age, and gender. In all, 89 volunteers (mean age 44.8 ± 18.0 years, range: 18-87 years) underwent MRI at 1.5T, and 88 of these subjects underwent MRI at 3.0T (1.4 ± 1.4 days between the scans). Compared with 3.0T, the magnitudes of global circumferential (-19.5 ± 2.6% vs. -18.47 ± 2.6%; P = 0.001) and longitudinal (-12.47 ± 3.2% vs. -10.53 ± 3.1%; P = 0.004) strain were greater at 1.5T. At 1.5T, longitudinal strain was greater in females than in males: -10.17 ± 3.4% vs. -13.67 ± 2.4%; P = 0.001. Similar observations occurred for circumferential strain at 1.5T (-18.72 ± 2.2% vs. -20.10 ± 2.7%; P = 0.014) and at 3.0T (-17.92 ± 1.8% vs. -19.1 ± 3.1%; P = 0.047). At 1.5T, longitudinal and circumferential strain were not associated with age after accounting for sex (longitudinal strain P = 0.178, circumferential strain P = 0.733). At 3.0T, longitudinal and circumferential strain were associated with age (P < 0.05). Longitudinal strain values were greater in the apico-septal, basal-lateral, and mid-lateral segments and circumferential strain in the inferior, infero-lateral, and antero-lateral LV segments. Myocardial strain parameters as revealed by cine-DENSE at different MRI field strengths were associated with myocardial region, age, and sex. J. Magn. Reson. Imaging 2016;44:1197-1205. © 2016 The Authors Journal of Magnetic Resonance Imaging published by Wiley Periodicals, Inc. on behalf of International Society for Magnetic Resonance in Medicine.

Large-Scale Wearable Sensor Deployment in Parkinson's Patients: The Parkinson@Home Study Protocol.

PubMed

Silva de Lima, Ana Lígia; Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

2016-08-26

Long-term management of Parkinson's disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients' own home environment) might fill this knowledge gap. The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson's patients during daily functioning. The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson's patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients' self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes. Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016. The Parkinson@Home study is expected to generate new insights into the feasibility of integrating self-collected information from wearable sensors into both daily routines and clinical practices for Parkinson's patients. This study represents an important step towards building a reliable system that translates and integrates real-life information into clinical decisions, with the long-term aim of delivering personalized disease management support. ClinicalTrials.gov NCT02474329; https://clinicaltrials.gov/ct2/show/NCT02474329 (Archived at http://www.webcitation.org/6joEc5P1v).

Large-Scale Wearable Sensor Deployment in Parkinson’s Patients: The Parkinson@Home Study Protocol

PubMed Central

Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

2016-01-01

Background Long-term management of Parkinson’s disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients’ own home environment) might fill this knowledge gap. Objective The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson’s patients during daily functioning. Methods The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson’s patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients’ self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes. Results Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016. Conclusions The Parkinson@Home study is expected to generate new insights into the feasibility of integrating self-collected information from wearable sensors into both daily routines and clinical practices for Parkinson’s patients. This study represents an important step towards building a reliable system that translates and integrates real-life information into clinical decisions, with the long-term aim of delivering personalized disease management support. ClinicalTrial ClinicalTrials.gov NCT02474329; https://clinicaltrials.gov/ct2/show/NCT02474329 (Archived at http://www.webcitation.org/6joEc5P1v) PMID:27565186

Study protocol for a longitudinal study evaluating the impact of rape on women’s health and their use of health services in South Africa

PubMed Central

Seedat, Soraya; Lombard, Carl; Kengne, Andre P; Myers, Bronwyn; Sewnath, Alesha; Mhlongo, Shibe; Ramjee, Gita; Peer, Nasheeta; Garcia-Moreno, Claudia; Jewkes, Rachel

2017-01-01

Introduction South Africa is a country known for its high levels of HIV infection and sexual violence. Although the interface between gender-based violence, HIV and mental health has been described, there are substantial gaps in knowledge of the medium-term and long-term health impact. The 2010 Global Burden of Disease study excluded many health outcomes associated with rape and other forms of gender-based violence because systematic reviews revealed huge gaps in data and poor evidence of health effects. This study aims to describe the incidence and attributable burden of physical and mental health problems (including HIV acquisition) in adult women over a 2-year postrape period, through comparison with a cohort of women who have not been raped. The study will substantially advance our understanding of the impact of rape and will generate robust data to assist in the development of postrape health services and the delivery of evidence-based care. Methods and analysis This longitudinal study seeks to recruit 1008 rape-exposed and 1008 rape non-exposed women. Women were recruited from health services, and assessments were carried out at baseline, 3, 6, 9, 12, 18 and 24 months. Outcome measures include exposure to risk factors; mental health status; cardio-metabolic risks; and biomarkers for HIV, sexually transmitted infections, pregnancy and stress. The primary analysis will be to compare HIV incidence in the two groups using log-rank tests. Appropriate models to predict health outcomes over time will also be applied. Ethics and dissemination The South African Medical Research Council’s Ethics Committee approved the study. As rape is a key element of the study, the safety and protection of participants guides the research process. We will adopt a research uptake strategy to ensure dissemination to policy makers, service providers and advocacy groups. Peer-reviewed journal articles will be published. PMID:28965098

Study protocol for the translating research in elder care (TREC): building context – an organizational monitoring program in long-term care project (project one)

PubMed Central

Estabrooks, Carole A; Squires, Janet E; Cummings, Greta G; Teare, Gary F; Norton, Peter G

2009-01-01

Background While there is a growing awareness of the importance of organizational context (or the work environment/setting) to successful knowledge translation, and successful knowledge translation to better patient, provider (staff), and system outcomes, little empirical evidence supports these assumptions. Further, little is known about the factors that enhance knowledge translation and better outcomes in residential long-term care facilities, where care has been shown to be suboptimal. The project described in this protocol is one of the two main projects of the larger five-year Translating Research in Elder Care (TREC) program. Aims The purpose of this project is to establish the magnitude of the effect of organizational context on knowledge translation, and subsequently on resident, staff (unregulated, regulated, and managerial) and system outcomes in long-term care facilities in the three Canadian Prairie Provinces (Alberta, Saskatchewan, Manitoba). Methods/Design This study protocol describes the details of a multi-level – including provinces, regions, facilities, units within facilities, and individuals who receive care (residents) or work (staff) in facilities – and longitudinal (five-year) research project. A stratified random sample of 36 residential long-term care facilities (30 urban and 6 rural) from the Canadian Prairie Provinces will comprise the sample. Caregivers and care managers within these facilities will be asked to complete the TREC survey – a suite of survey instruments designed to assess organizational context and related factors hypothesized to be important to successful knowledge translation and to achieving better resident, staff, and system outcomes. Facility and unit level data will be collected using standardized data collection forms, and resident outcomes using the Resident Assessment Instrument-Minimum Data Set version 2.0 instrument. A variety of analytic techniques will be employed including descriptive analyses, psychometric analyses, multi-level modeling, and mixed-method analyses. Discussion Three key challenging areas associated with conducting this project are discussed: sampling, participant recruitment, and sample retention; survey administration (with unregulated caregivers); and the provision of a stable set of study definitions to guide the project. PMID:19671166

Comparative Evaluation of the Effects of Nd:YAG Laser and a Desensitizer Agent on the Treatment of Dentin Hypersensitivity: A Clinical Study

PubMed Central

Lopes, Anely Oliveira

2013-01-01

Abstract Objective: The aim of this randomized longitudinal clinical study was to assess different treatment protocols for dentin hypersensitivity with high-power laser, desensitizing agent, and its association between high-power laser and desensitizing agent, for a period of 6 months. Background data: The literature shows a lack of treatment for dentin hypersensitivity, and lasers are contemporary alternatives. Methods: After inclusion and exclusion analysis, volunteers were selected. The lesions were divided into three groups (n=10): G1, Gluma Desensitizer (Heraeus Kulzer); G2, Nd:YAG Laser (Power Laser™ ST6, Lares Research®) contact mode, laser protocol of 1.5 W, 10 Hz, and 100 mJ,≈85 J/cm2, four irradiations performed, each for 15 sec, in mesiodistal and occluso-apical directions, totaling 60 sec of irradiation with intervals of 10 sec between them; G3, Nd:YAG Laser+Gluma Desensitizer. The level of sensitivity to pain of each volunteer was analyzed by visual analog scale (VAS) using cold air stimuli and exploratory probe 5 min, 1 week, and 1, 3, and 6 months after treatment. Data were collected and subjected to statistical analysis that detected statistically significant differences between the various studied time intervals of treatments (p>0.05). Results: For the air stimulus, no significant differences were found for each time interval. For the long-term evaluation, all groups showed statistical differences (p>0.05), indicating that for G2 and G3, this difference was statistically significant from the first time of evaluation (post 1), whereas in G1, the difference was significant from the post 2 evaluation (1 week). Comparison among groups using the probe stimulation showed significant differences in pain (p<0.001). Only in G1 and G3 did this difference become significant from post 01. Conclusions: All protocols were effective in reducing dentinal hypersensitivity after 6 months of treatment; however, the association of Nd:YAG and Gluma Desensitizer is an effective treatment strategy that has immediate and long-lasting effects. PMID:23421629

Ecological Momentary Assessment in Behavioral Research: Addressing Technological and Human Participant Challenges.

PubMed

Burke, Lora E; Shiffman, Saul; Music, Edvin; Styn, Mindi A; Kriska, Andrea; Smailagic, Asim; Siewiorek, Daniel; Ewing, Linda J; Chasens, Eileen; French, Brian; Mancino, Juliet; Mendez, Dara; Strollo, Patrick; Rathbun, Stephen L

2017-03-15

Ecological momentary assessment (EMA) assesses individuals' current experiences, behaviors, and moods as they occur in real time and in their natural environment. EMA studies, particularly those of longer duration, are complex and require an infrastructure to support the data flow and monitoring of EMA completion. Our objective is to provide a practical guide to developing and implementing an EMA study, with a focus on the methods and logistics of conducting such a study. The EMPOWER study was a 12-month study that used EMA to examine the triggers of lapses and relapse following intentional weight loss. We report on several studies that informed the implementation of the EMPOWER study: (1) a series of pilot studies, (2) the EMPOWER study's infrastructure, (3) training of study participants in use of smartphones and the EMA protocol and, (4) strategies used to enhance adherence to completing EMA surveys. The study enrolled 151 adults and had 87.4% (132/151) retention rate at 12 months. Our learning experiences in the development of the infrastructure to support EMA assessments for the 12-month study spanned several topic areas. Included were the optimal frequency of EMA prompts to maximize data collection without overburdening participants; the timing and scheduling of EMA prompts; technological lessons to support a longitudinal study, such as proper communication between the Android smartphone, the Web server, and the database server; and use of a phone that provided access to the system's functionality for EMA data collection to avoid loss of data and minimize the impact of loss of network connectivity. These were especially important in a 1-year study with participants who might travel. It also protected the data collection from any server-side failure. Regular monitoring of participants' response to EMA prompts was critical, so we built in incentives to enhance completion of EMA surveys. During the first 6 months of the 12-month study interval, adherence to completing EMA surveys was high, with 88.3% (66,978/75,888) completion of random assessments and around 90% (23,411/25,929 and 23,343/26,010) completion of time-contingent assessments, despite the duration of EMA data collection and challenges with implementation. This work informed us of the necessary preliminary steps to plan and prepare a longitudinal study using smartphone technology and the critical elements to ensure participant engagement in the potentially burdensome protocol, which spanned 12 months. While this was a technology-supported and -programmed study, it required close oversight to ensure all elements were functioning correctly, particularly once human participants became involved. ©Lora E Burke, Saul Shiffman, Edvin Music, Mindi A Styn, Andrea Kriska, Asim Smailagic, Daniel Siewiorek, Linda J Ewing, Eileen Chasens, Brian French, Juliet Mancino, Dara Mendez, Patrick Strollo, Stephen L Rathbun. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.03.2017.

E6 and E7 Antibody Levels Are Potential Biomarkers of Recurrence in Patients with Advanced-Stage Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma.

PubMed

Spector, Matthew E; Sacco, Assuntina G; Bellile, Emily; Taylor, Jeremy M G; Jones, Tamara; Sun, Kan; Brown, William C; Birkeland, Andrew C; Bradford, Carol R; Wolf, Gregory T; Prince, Mark E; Moyer, Jeffrey S; Malloy, Kelly; Swiecicki, Paul; Eisbruch, Avraham; McHugh, Jonathan B; Chepeha, Douglas B; Rozek, Laura; Worden, Francis P

2017-06-01

Purpose: There is a paucity of biomarkers to predict failure in human papillomavirus-positive (HPV + ) oropharyngeal squamous cell carcinoma (OPSCC) following curative therapy. E6/E7 viral oncoproteins are constitutively expressed in HPV + tumors and highly immunogenic, resulting in readily detected serum antibodies. The purpose of this study is to determine whether serum E6 and E7 antibody levels can potentially serve as a biomarker of recurrence in patients with HPV+OPSCC. Experimental Design: We evaluated E6/E7 antibody levels in patients with previously untreated, advanced stage (III, IVa-b), HPV+OPSCC receiving definitive chemoradiation under a uniform protocol from 2003 to 2010. Baseline and longitudinal serum samples were obtained from our archived repository. E6/E7 serum levels were measured using a glutathione- S -transferase capture ELISA and quantified by approximating the area under the dilution curve, and were analyzed using ANOVA and linear mixed model for longitudinal analysis. Results: We compared 22 HPV+OPSCC patients who developed recurrence with 30 patients who remained disease-free. There were no differences in T classification, N classification, disease subsite, or smoking status between the groups. In a longitudinal analysis, recurrent patients had significantly higher E6 and E7 serum antibody levels than the nonrecurrent patients over the follow-up period ( P = 0.02 and P = 0.002, respectively). Patients who recurred had a lower clearance of E7 antibody than patients who remained disease-free ( P = 0.0016). Conclusions: Patients with HPV+OPSCC whose disease recurs have a lower clearance of E6 and E7 antibodies than patients who do not have recurrence. The ratio of E7 antibody at disease recurrence compared with baseline is potentially a clinically significant measurement of disease status in HPV+OPSCC. Clin Cancer Res; 23(11); 2723-9. ©2016 AACR . ©2016 American Association for Cancer Research.

Early Clinical Outcomes Demonstrate Preserved Cognitive Function in Children With Average-Risk Medulloblastoma When Treated With Hyperfractionated Radiation Therapy

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

Gupta, Tejpal, E-mail: tejpalgupta@rediffmail.com; Jalali, Rakesh; Goswami, Savita

Purpose: To report on acute toxicity, longitudinal cognitive function, and early clinical outcomes in children with average-risk medulloblastoma. Methods and Materials: Twenty children {>=}5 years of age classified as having average-risk medulloblastoma were accrued on a prospective protocol of hyperfractionated radiation therapy (HFRT) alone. Radiotherapy was delivered with two daily fractions (1 Gy/fraction, 6 to 8 hours apart, 5 days/week), initially to the neuraxis (36 Gy/36 fractions), followed by conformal tumor bed boost (32 Gy/32 fractions) for a total tumor bed dose of 68 Gy/68 fractions over 6 to 7 weeks. Cognitive function was prospectively assessed longitudinally (pretreatment and atmore » specified posttreatment follow-up visits) with the Wechsler Intelligence Scale for Children to give verbal quotient, performance quotient, and full-scale intelligence quotient (FSIQ). Results: The median age of the study cohort was 8 years (range, 5-14 years), representing a slightly older cohort. Acute hematologic toxicity was mild and self-limiting. Eight (40%) children had subnormal intelligence (FSIQ <85), including 3 (15%) with mild mental retardation (FSIQ 56-70) even before radiotherapy. Cognitive functioning for all tested domains was preserved in children evaluable at 3 months, 1 year, and 2 years after completion of HFRT, with no significant decline over time. Age at diagnosis or baseline FSIQ did not have a significant impact on longitudinal cognitive function. At a median follow-up time of 33 months (range, 16-58 months), 3 patients had died (2 of relapse and 1 of accidental burns), resulting in 3-year relapse-free survival and overall survival of 83.5% and 83.2%, respectively. Conclusion: HFRT without upfront chemotherapy has an acceptable acute toxicity profile, without an unduly increased risk of relapse, with preserved cognitive functioning in children with average-risk medulloblastoma.« less

Immigrant family skills-building to prevent tobacco use in Latino youth: study protocol for a community-based participatory randomized controlled trial

PubMed Central

2012-01-01

Background Despite declines over recent years, youth tobacco and other substance use rates remain high. Latino youth are at equal or increased risk for lifetime tobacco, alcohol, marijuana, and other illicit drug use compared with their white peers. Family plays an important and influential role in the lives of youth, and longitudinal research suggests that improving parenting skills may reduce youth substance use. However, few interventions are oriented towards immigrant Latino families, and none have been developed and evaluated using a community-based participatory research (CBPR) process that may increase the effectiveness and sustainability of such projects. Therefore, using CBPR principles, we developed a randomized clinical trial to assess the efficacy of a family-skills training intervention to prevent tobacco and other substance use intentions in Latino youth. Methods/Design In collaboration with seven Latino community-serving agencies, we will recruit and randomize 336 immigrant families, into intervention or delayed treatment conditions. The primary outcome is youth intention to smoke 6 months post intervention. The intervention consists of eight parent and four youth sessions targeting parenting skills and parent–youth relational factors associated with lower smoking and other substance use in youth. Discussion We present the study protocol for a family intervention using a CBPR randomized clinical trial to prevent smoking among Latino youth. The results of this trial will contribute to the limited information on effective and sustainable primary prevention programs for tobacco and other substance use directed at the growing US Latino communities. Trial registration ClinicalTrials.gov: NCT01442753 PMID:23253201

Unexplained infertility: overall ongoing pregnancy rate and mode of conception.

PubMed

Brandes, M; Hamilton, C J C M; van der Steen, J O M; de Bruin, J P; Bots, R S G M; Nelen, W L D M; Kremer, J A M

2011-02-01

Unexplained infertility is one of the most common diagnoses in fertility care. The aim of this study was to evaluate the outcome of current fertility management in unexplained infertility. In an observational, longitudinal, multicentre cohort study, 437 couples were diagnosed with unexplained infertility and were available for analysis. They were treated according to their prognosis using standing national treatment protocols: (i) expectant management-IUI-IVF (main treatment route), (ii) IUI-IVF and (iii) directly IVF. Primary outcome measures were: ongoing pregnancy rate, patient flow over the strategies, numbers of protocol violation and drop out rates. A secondary outcome measure was the prediction of ongoing pregnancy and mode of conception. Of all couples 81.5% (356/437) achieved an ongoing pregnancy and 73.9% (263/356) of the pregnancies were conceived spontaneously. There were 408 couples (93.4%) in strategy-1, 21 (5.0%) in strategy-2 and 8 (1.8%) in strategy-3. In total, 33 (7.6%) couples entered the wrong strategy. There were 104 couples (23.8%) who discontinued fertility treatment prematurely: 26 on doctor's advice (with 4 still becoming pregnant) and 78 on their own initiative (with 33 still achieving a pregnancy). Predictors for overall pregnancy chance and mode of conception were duration of infertility, female age and obstetrical history. Overall success rate in couples with unexplained infertility is high. Most pregnancies are conceived spontaneously. We recommend that if the pregnancy prognosis is good, expectant management should be suggested. The prognosis criteria for treatment with IUI or IVF needs to be investigated in randomized controlled trials.

Stimulated echo diffusion tensor imaging and SPAIR T2 -weighted imaging in chronic exertional compartment syndrome of the lower leg muscles.

PubMed

Sigmund, Eric E; Sui, Dabang; Ukpebor, Obehi; Baete, Steven; Fieremans, Els; Babb, James S; Mechlin, Michael; Liu, Kecheng; Kwon, Jane; McGorty, KellyAnne; Hodnett, Philip A; Bencardino, Jenny

2013-11-01

To evaluate the performance of diffusion tensor imaging (DTI) in the evaluation of chronic exertional compartment syndrome (CECS) as compared to T2 -weighted (T2w) imaging. Using an Institutional Review Board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, spectral adiabatic inversion recovery (SPAIR) T2w imaging and stimulated echo DTI were applied to eight healthy volunteers and 14 suspected CECS patients before and after exertion. Longitudinal and transverse diffusion eigenvalues, mean diffusivity (MD), and fractional anisotropy (FA) were measured in seven calf muscle compartments, which in patients were classified by their response on T2w: normal (<20% change), and CECS (>20% change). Mixed model analysis of variance compared subject groups and compartments in terms of response factors (post/pre-exercise ratios) of DTI parameters. All diffusivities significantly increased (P < 0.0001) and FA decreased (P = 0.0014) with exercise. Longitudinal diffusion responses were significantly smaller than transversal diffusion responses (P < 0.0001). Nineteen of 98 patient compartments were classified as CECS on T2w. MD increased by 3.8 ± 3.4% (volunteer), 7.4 ± 4.2% (normal), and 9.1 ± 7.0% (CECS) with exercise. DTI shows promise as an ancillary imaging method in the diagnosis and understanding of the pathophysiology in CECS. Future studies may explore its utility in predicting response to treatment. Copyright © 2013 Wiley Periodicals, Inc.

Health-related quality-of-life outcomes: a reflexology trial with patients with advanced-stage breast cancer.

PubMed

Wyatt, Gwen; Sikorskii, Alla; Rahbar, Mohammad Hossein; Victorson, David; You, Mei

2012-11-01

To evaluate the safety and efficacy of reflexology, a complementary therapy that applies pressure to specific areas of the feet. Longitudinal, randomized clinical trial. Thirteen community-based medical oncology clinics across the midwestern United States. A convenience sample of 385 predominantly Caucasian women with advanced-stage breast cancer receiving chemotherapy and/or hormonal therapy. Following the baseline interview, women were randomized into three primary groups: reflexology (n = 95), lay foot manipulation (LFM) (n = 95), or conventional care (n = 96). Two preliminary reflexology (n = 51) and LFM (n = 48) test groups were used to establish the protocols. Participants were interviewed again postintervention at study weeks 5 and 11. Breast cancer-specific health-related quality of life (HRQOL), physical functioning, and symptoms. No adverse events were reported. A longitudinal comparison revealed significant improvements in physical functioning for the reflexology group compared to the control group (p = 0.04). Severity of dyspnea was reduced in the reflexology group compared to the control group (p < 0.01) and the LFM group (p = 0.02). No differences were found on breast cancer-specific HRQOL, depressive symptomatology, state anxiety, pain, and nausea. Reflexology may be added to existing evidence-based supportive care to improve HRQOL for patients with advanced-stage breast cancer during chemotherapy and/or hormonal therapy. Reflexology can be recommended for safety and usefulness in relieving dyspnea and enhancing functional status among women with advanced-stage breast cancer.

The relationship between allometry and preferred transition speed in human locomotion.

PubMed

Ranisavljev, Igor; Ilic, Vladimir; Soldatovic, Ivan; Stefanovic, Djordje

2014-04-01

The purpose of this study was to explore the relationships between preferred transition speed (PTS) and anthropometric characteristics, body composition and different human body proportions in males. In a sample of 59 male students, we collected anthropometric and body composition data and determined individual PTS using increment protocol. The relationships between PTS and other variables were determined using Pearson correlation, stepwise linear and hierarchical regression. Body ratios were formed as quotient of two variables whereby at least one significantly correlated to PTS. Circular and transversal (except bitrochanteric diameter) body dimensions did not correlate with PTS. Moderate correlations were found between longitudinal leg dimensions (foot, leg and thigh length) and PTS, while the highest correlation was found for lower leg length (r=.488, p<.01). Two parameters related to body composition showed weak correlation with PTS: body fat mass (r=-.250, p<.05) and amount of lean leg mass scaled to body weight (r=.309, p<.05). Segmental body proportions correlated more significantly with PTS, where thigh/lower leg length ratio showed the highest correlation (r=.521, p<.01). Prediction model with individual variables (lower leg and foot length) have explained just 31% of PTS variability, while model with body proportions showed almost 20% better prediction (R(2)=.504). These results suggests that longitudinal leg dimensions have moderate influence on PTS and that segmental body proportions significantly more explain PTS than single anthropometric variables. Copyright © 2014 Elsevier B.V. All rights reserved.

Effects of fatigue induced damage on the longitudinal fracture resistance of cortical bone.

PubMed

Fletcher, Lloyd; Codrington, John; Parkinson, Ian

2014-07-01

As a composite material, cortical bone accumulates fatigue microdamage through the repetitive loading of everyday activity (e.g. walking). The accumulation of fatigue microdamage is thought to contribute to the occurrence of fragility fractures in older people. Therefore it is beneficial to understand the relationship between microcrack accumulation and the fracture resistance of cortical bone. Twenty longitudinally orientated compact tension fracture specimens were machined from a single bovine femur, ten specimens were assigned to both the control and fatigue damaged groups. The damaged group underwent a fatigue loading protocol to induce microdamage which was assessed via fluorescent microscopy. Following fatigue loading, non-linear fracture resistance tests were undertaken on both the control and damaged groups using the J-integral method. The interaction of the crack path with the fatigue induced damage and inherent toughening mechanisms were then observed using fluorescent microscopy. The results of this study show that fatigue induced damage reduces the initiation toughness of cortical bone and the growth toughness within the damage zone by three distinct mechanisms of fatigue-fracture interaction. Further analysis of the J-integral fracture resistance showed both the elastic and plastic component were reduced in the damaged group. For the elastic component this was attributed to a decreased number of ligament bridges in the crack wake while for the plastic component this was attributed to the presence of pre-existing fatigue microcracks preventing energy absorption by the formation of new microcracks.

Camden active spaces: does the construction of active school playgrounds influence children's physical activity levels? A longitudinal quasi-experiment protocol.

PubMed

Smith, Lee; Kipps, Courtney; Aggio, Daniel; Fox, Paul; Robinson, Nigel; Trend, Verena; Munnery, Suzie; Kelly, Barry; Hamer, Mark

2014-01-01

Physical activity is essential for every facet of children's health. However, physical activity levels in British children are low. The school environment is a promising setting to increase children's physical activity but limited empirical evidence exists on how a change in the outdoor physical school environment influences physical activity behaviour. The London Borough of Camden is redesigning seven existing school playgrounds to engage children to become more physically active. The primary aim of this project is to evaluate the impact of the redesigned playgrounds on children's physical activity, well-being and physical function/fitness. This project will use a longitudinal quasi-experimental design. Seven experimental schools and one control school will take part. One baseline data collection session and two follow-ups will be carried out. Between baseline and follow-up, the experimental school playgrounds will be redesigned. At baseline, a series of fitness tests, anthropometric and questionnaire measurements, and 7-day objective physical activity monitoring (Actigraph accelerometer) will be carried out on children (aged 5–16 years). This will be repeated at follow-up. Changes in overall physical activity levels and levels during different times of the day (eg, school breaks) will be examined. Multilevel regression modelling will be used to analyse the data. The results of this study will be disseminated through peer-review publications and scientific presentations. Ethical approval was obtained through the University College London Research Ethics Committee (Reference number: 4400/002).

Protocol for a 1-year prospective, longitudinal cohort study of patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy: the BARI-LIFESTYLE observational study

PubMed Central

Jassil, Friedrich C; Carnemolla, Alisia; Kingett, Helen; Paton, Bruce; O’Keeffe, Aidan G; Doyle, Jacqueline; Morris, Stephen; Lewis, Neville; Kirk, Amy; Pucci, Andrea; Chaiyasoot, Kusuma; Batterham, Rachel L

2018-01-01

Introduction Roux-en-Y gastric bypass and sleeve gastrectomy are the two most common bariatric surgery performed in the UK that result in comparable weight loss and remission of obesity-associated comorbidities. However, there is a paucity of studies examining the impact of these procedures on body composition, physical activity levels, sedentary behaviour, physical function and strength, dietary intake, health-related quality of life and costs. Methods and analysis The BARI-LIFESTYLE observational study is a 1-year prospective, longitudinal cohort study within a real-world routine clinical care setting aiming to recruit 100 patients with severe obesity undergoing either primary Roux-en-Y gastric bypass or sleeve gastrectomy from two bariatric centres in London, UK. Participants will be followed up four times during the study period; presurgery baseline (T0) and at 3 (T1), 6 (T2) and 12 months (T3) postsurgery. In addition to the standard follow-up investigations, assessments including dual-energy X-ray absorptiometry scan, bioelectric impedance analysis, 6 min walk test, sit-to-stand test and handgrip test will be undertaken together with completion of questionnaires. Physical activity levels and sedentary behaviour will be assessed using accelerometer, and dietary intake will be recorded using a 3-day food diary. Outcome measures will include body weight, body fat mass, lean muscle mass, bone mineral density, physical activity levels, sedentary behaviour, physical function and strength, dietary intake, health-related quality of life, remission of comorbidities, healthcare resource utilisation and costs. Ethics and dissemination This study has been reviewed and given a favourable ethical opinion by London-Dulwich Research Ethics Committee (17/LO/0950). The results will be presented to stakeholder groups locally, nationally and internationally and published in peer-reviewed medical journals. The lay-person summary of the findings will be published on the Centre for Obesity Research, University College London website (http://www.ucl.ac.uk/obesity). PMID:29549212

Short and long-term effectiveness of couple counselling: a study protocol

PubMed Central

2012-01-01

Background Healthy couple relationships are fundamental to a healthy society, whereas relationship breakdown and discord are linked to a wide range of negative health and wellbeing outcomes. Two types of relationship services (couple counselling and relationship education) have demonstrated efficacy in many controlled studies but evidence of the effectiveness of community-based relationship services has lagged behind. This study protocol describes an effectiveness evaluation of the two types of community-based relationship services. The aims of the Evaluation of Couple Counselling study are to: map the profiles of clients seeking agency-based couple counselling and relationship enhancement programs in terms of socio-demographic, relationship, health, and health service use indicators; to determine 3 and 12-month outcomes for relationship satisfaction, commitment, and depression; and determine relative contributions of client and therapy factors to outcomes. Methods/Design A quasi-experimental pre-post-post evaluation design is used to assess outcomes for couples presenting for the two types of community-based relationship services. The longitudinal design involves a pre-treatment survey and two follow-up surveys at 3- and 12-months post-intervention. The study is set in eight Relationships Australia Victoria centres, across metropolitan, outer suburbs, and regional/rural sites. Relationships Australia, a non-government organisation, is the largest provider of couple counselling and relationship services in Australia. The key outcomes are couple satisfaction, relationship commitment, and depression measured by the CESD-10. Multi-level modelling will be used to account for the dyadic nature of couple data. Discussion The study protocol describes the first large scale investigation of the effectiveness of two types of relationship services to be conducted in Australia. Its significance lies in providing more detailed profiles of couples who seek relationship services, in evaluating both 3 and 12-month relationship and health outcomes, and in determining factors that best predict improvements. It builds on prior research by using a naturalistic sample, an effectiveness research design, a more robust measure of relationship satisfaction, robust health indicators, a 12-month follow-up period, and a more rigorous statistical procedure suitable for dyadic data. Findings will provide a more precise description of those seeking relationship services and factors associated with improved relationship and health outcomes. PMID:22943742

Development of the Tailored Rett Intervention and Assessment Longitudinal (TRIAL) database and the Rett Evaluation of Symptoms and Treatments (REST) Questionnaire.

PubMed

Santosh, Paramala; Lievesley, Kate; Fiori, Federico; Singh, Jatinder

2017-06-21

Rett syndrome (RTT) is a pervasive neurodevelopmental disorder that presents with deficits in brain functioning leading to language and learning regression, characteristic hand stereotypies and developmental delay. Different mutations in the gene implicated in RTT- methyl-CpG-binding protein 2 ( MECP2 ) establishes RTT as a disorder with divergent symptomatology ranging from individuals with severe to milder phenotypes. A reliable and single multidimensional questionnaire is needed that can embrace all symptoms, and the relationships between them, and can map clinically meaningful data to symptomatology across the lifespan in patients with RTT. As part of the HealthTracker-based Tailored Rett Intervention and Assessment Longitudinal (TRIAL) database, the Rett Evaluation of Symptoms and Treatments (REST) Questionnaire will be able to marry with the physiological aspects of the disease obtained using wearable sensor technology, along with genetic and psychosocial data to stratify patients. Taken together, the web-based TRIAL database will empower clinicians and researchers with the confidence to delineate between different aspects of disorder symptomatology to streamline care pathways for individuals or for those patients entering clinical trials. This protocol describes the anticipated development of the REST questionnaire and the TRIAL database which links with the outcomes of the wearable sensor technology, and will serve as a barometer for longitudinal patient monitoring in patients with RTT. The US Food and Drug Administration Guidance for Patient-Reported Outcome Measures will be used as a template to inform the methodology of the study. It will follow an iterative framework that will include item/concept identification, item/concept elicitation in parent/carer-mediated focus groups, expert clinician feedback, web-based presentation of questionnaires, initial scale development, instrument refinement and instrument validation. The study has received favourable opinion from the National Health Service (NHS) Research Ethics Committee (REC): NHS Research Ethics Committee (REC)-London, Bromley Research Ethics Committee (reference: 15/LO/1772). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Long-Term Impact of Implementation of a Stroke Protocol on Door-to-Needle Time in the Administration of Intravenous Tissue Plasminogen Activator.

PubMed

Hillen, Machteld E; He, Wenzhuan; Al-Qudah, Zaid; Wang, Weizhen; Hidalgo, Andrea; Walia, Jessy

2017-07-01

This study aims to evaluate the effectiveness of implementing a stroke protocol (SP) in improving door-to-needle time (DTNT) and door-to-computed tomography (DTCT) time from 2010 to 2014. Published data from the Get With The Guidelines-Stroke (GWTGS) participating hospitals showed that median DTNT = 75 minutes with 26.6% of the patients achieving the recommended DTNT of 60 minutes or less. Implementation of an SP, which specifies the role of nurses, physicians, and technicians during acute stroke evaluation, can improve DTNT. This longitudinal quality assurance study was designed to compare the DTNT and the DTCT time pre- and post implementation of an SP in our hospital. Patients' data before (2009-2010) and after (2010-2014) the implementation of an SP were collected each year during the same 6-month period and compared using statistical software SPSS 20.0 for Windows (SPSS Inc., Chicago, IL). Although our DTNT did not significantly improve over the years, the median DTNT (59 minutes) was much less than the reported 75 minutes of GWTGS hospitals. Our DTCT time diminished from 20.6 minutes in 2009 to 15.9 minutes in 2014. The percentage of patients with a DTNT of 1 hour or less did not differ among all years (P = .296) and was 55.8%. Our study suggests that our performance in evaluating acute ischemic stroke patients within the American Heart Association/American Stroke Association suggested time window is reachable for prolonged periods of time. Continuous monitoring and education of all players involved are crucial to ensure best possible outcomes in the timely administration of intravenous tissue plasminogen activator. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Protocol for a mixed methods study investigating the impact of investment in housing, regeneration and neighbourhood renewal on the health and wellbeing of residents: the GoWell programme

PubMed Central

2010-01-01

Background There is little robust evidence to test the policy assumption that housing-led area regeneration strategies will contribute to health improvement and reduce social inequalities in health. The GoWell Programme has been designed to measure effects on health and wellbeing of multi-faceted regeneration interventions on residents of disadvantaged neighbourhoods in the city of Glasgow, Scotland. Methods/Design This mixed methods study focused (initially) on 14 disadvantaged neighbourhoods experiencing regeneration. These were grouped by intervention into 5 categories for comparison. GoWell includes a pre-intervention householder survey (n = 6008) and three follow-up repeat-cross sectional surveys held at two or three year intervals (the main focus of this protocol) conducted alongside a nested longitudinal study of residents from 6 of those areas. Self-reported responses from face-to-face questionnaires are analysed along with various routinely produced ecological data and documentary sources to build a picture of the changes taking place, their cost and impacts on residents and communities. Qualitative methods include interviews and focus groups of residents, housing managers and other stakeholders exploring issues such as the neighbourhood context, potential pathways from regeneration to health, community engagement and empowerment. Discussion Urban regeneration programmes are 'natural experiments.' They are complex interventions that may impact upon social determinants of population health and wellbeing. Measuring the effects of such interventions is notoriously challenging. GoWell compares the health and wellbeing effects of different approaches to regeneration, generates theory on pathways from regeneration to health and explores the attitudes and responses of residents and other stakeholders to neighbourhood change. PMID:20459767

The Perinatal Adverse events and Special Trends in Cognitive Trajectory (PLASTICITY) - pre-protocol for a prospective longitudinal follow-up cohort study

PubMed Central

Hokkanen, Laura

2013-01-01

Prospective follow-up studies on long term effects of pre- and perinatal adverse conditions in adulthood are rare. We will continue to follow the prospective cohort of initially 1196 subjects with predefined at-delivery risk factors out of 22,359 consecutive deliveries during 1971-74 at a single maternity hospital. The risk cohort and 93 controls have been followed up with a comprehensive clinical program at 5, 9, and 16 years of age and by questionnaire at the age of 30 years. Major medical events known to affect the development and growth of the brain, or cognitive functions and personality have been documented. Here we present a pre-protocol for the project, which we will call PLASTICITY, whose aim is to follow consenting subjects and controls into mid-adulthood and beyond, and to explore how the neonatal risk factors modulate neurodevelopmental and neurodegenerative processes such as learning disabilities, ADHD, aging, early onset mild cognitive impairment and even dementia. Our first focus is on the neurological and cognitive outcomes at age 40 years, using detailed neurological, neuropsychological, neuroimaging, genetic, blood chemistry and registry based methods. Results will be expected to offer information on the risk of neurological, psychiatric, metabolic and other medical consequences as well as the need for health and social services at the brink of middle age, when new degenerative phenomena are known to emerge. The evaluation at age 40 years will serve as a baseline for later aging studies. We welcome all comments and suggestions, which we will apply in finalizing details and inviting collaboration. PMID:24358867

The International Alcohol Control (IAC) study-evaluating the impact of alcohol policies.

PubMed

Casswell, Sally; Meier, Petra; MacKintosh, Anne M; Brown, Abraham; Hastings, Gerard; Thamarangsi, Thaksaphon; Chaiyasong, Surasak; Chun, Sungsoo; Huckle, Taisia; Wall, Martin; You, Ru Q

2012-08-01

This paper describes a new multicountry collaborative project to assess the impact of alcohol control policy. Longitudinal surveys of drinkers in a number of participating countries and analysis of the policy context allow for the assessment of change over time within countries and comparison between countries. The design of the study is modeled on the International Tobacco Control study and aims to assess the impact of alcohol policies in different cultural contexts on policy-related behaviors and alcohol consumption. A survey instrument and protocol for policy analysis have been developed by the initial participating countries: England, Scotland, Thailand, South Korea, and New Zealand. The first round of data collection is scheduled for 2011-2012. The survey instrument (International Alcohol Control [IAC] survey) measures key policy relevant behaviors: place and time of purchase, amounts purchased and price paid; ease of access to alcohol purchase; alcohol marketing measures; social supply; perceptions of alcohol affordability and availability and salience of price; perceptions of enforcement; people's experiences with specific alcohol restrictions; support for policy and consumption (typical quantity, frequency using beverage and location-specific measures). The Policy Analysis Protocol (PoLAP) assesses relevant aspects of the policy environment including regulation and implementation. It has proved feasible to design instruments to collect detailed data on behaviors relevant to alcohol policy change and to assess the policy environment in different cultural settings. In a policy arena in which the interest groups and stakeholders have different perceptions of appropriate policy responses to alcohol-related harm, a robust methodology to assess the impact of policy will contribute to the debate. Copyright © 2012 by the Research Society on Alcoholism.

Trajectories of Mental Health over 16 Years amongst Young Adult Women: The Australian Longitudinal Study on Women's Health

ERIC Educational Resources Information Center

Holden, Libby; Ware, Robert S.; Lee, Christina

2016-01-01

This article used data from 5,171 young women participating in the Australian Longitudinal Study on Women's Health, a nationally representative longitudinal cohort study, to identify longitudinal trajectory patterns of mental health across 6 surveys over 16 years of early adulthood, from age 18-23 to age 34-39. In addition, we identified both…

A Longitudinal Examination of Childhood Maltreatment and Adolescent Obesity: Results from the National Longitudinal Study of Adolescent Health (AddHealth) Study

ERIC Educational Resources Information Center

Shin, Sunny Hyucksun; Miller, Daniel P.

2012-01-01

Objectives: We sought to explore the association between childhood maltreatment (e.g., neglect, physical and sexual abuse) and longitudinal growth trajectories of body mass index (BMI) from adolescence to young adulthood. Methods: We used latent curve modeling to examine data from the National Longitudinal Study of Adolescent Health (N = 8,471),…

Coping with Memory Effect and Serial Correlation when Estimating Reliability in a Longitudinal Framework

ERIC Educational Resources Information Center

Laenen, Annouschka; Alonso, Ariel; Molenberghs, Geert; Vangeneugden, Tony; Mallinckrodt, Craig H.

2010-01-01

Longitudinal studies are permeating clinical trials in psychiatry. Therefore, it is of utmost importance to study the psychometric properties of rating scales, frequently used in these trials, within a longitudinal framework. However, intrasubject serial correlation and memory effects are problematic issues often encountered in longitudinal data.…

Non-pharmacological interventions on cognitive functions in older people with mild cognitive impairment (MCI).

PubMed

Teixeira, Camila Vieira Ligo; Gobbi, Lilian Teresa Bucken; Corazza, Danilla Icassatti; Stella, Florindo; Costa, José Luiz Riani; Gobbi, Sebastião

2012-01-01

Mild cognitive impairment (MCI) can be a stage of pre-dementia. There is no consensus about pharmacological treatment for this population, so it is important to structure non-pharmacological interventions for increasing their cognitive reserve. We intended to analyze the effects of non-pharmacological interventions in the cognitive functions in older people with MC, in form of a systemic review. Data sources were the Web of Science, Biological Abstracts, Medline, Pub Med, EBSCHost, Scirus and Google Scholar. All studies were longitudinal trials, with MCI sample, aged>60 years, community-dwelling, and having cognitive functions as dependent variable. Seven studies, from 91 previously selected ones, were identified according to the inclusion criteria. Six studies used cognitive intervention, improving memory and one study used physical activity as intervention, improving executive functions. The results show evidence that physical activity and cognitive exercise may improve memory and executive functions in older people with MCI. But yet, more controlled studies are needed to establish a protocol of recommendations regarding the systemization of exercise, necessary to produce benefits in the cognitive functioning in older people with MCI. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Use of missing data methods in longitudinal studies: the persistence of bad practices in developmental psychology.

PubMed

Jelicić, Helena; Phelps, Erin; Lerner, Richard M

2009-07-01

Developmental science rests on describing, explaining, and optimizing intraindividual changes and, hence, empirically requires longitudinal research. Problems of missing data arise in most longitudinal studies, thus creating challenges for interpreting the substance and structure of intraindividual change. Using a sample of reports of longitudinal studies obtained from three flagship developmental journals-Child Development, Developmental Psychology, and Journal of Research on Adolescence-we examined the number of longitudinal studies reporting missing data and the missing data techniques used. Of the 100 longitudinal studies sampled, 57 either reported having missing data or had discrepancies in sample sizes reported for different analyses. The majority of these studies (82%) used missing data techniques that are statistically problematic (either listwise deletion or pairwise deletion) and not among the methods recommended by statisticians (i.e., the direct maximum likelihood method and the multiple imputation method). Implications of these results for developmental theory and application, and the need for understanding the consequences of using statistically inappropriate missing data techniques with actual longitudinal data sets, are discussed.

Measurement of backbone hydrogen-deuterium exchange in the type III secretion system needle protein PrgI by solid-state NMR

NASA Astrophysics Data System (ADS)

Chevelkov, Veniamin; Giller, Karin; Becker, Stefan; Lange, Adam

2017-10-01

In this report we present site-specific measurements of amide hydrogen-deuterium exchange rates in a protein in the solid state phase by MAS NMR. Employing perdeuteration, proton detection and a high external magnetic field we could adopt the highly efficient Relax-EXSY protocol previously developed for liquid state NMR. According to this method, we measured the contribution of hydrogen exchange on apparent 15N longitudinal relaxation rates in samples with differing D2O buffer content. Differences in the apparent T1 times allowed us to derive exchange rates for multiple residues in the type III secretion system needle protein.

Advancing Concussion Assessment in Pediatrics (A-CAP): a prospective, concurrent cohort, longitudinal study of mild traumatic brain injury in children: study protocol

PubMed Central

Beauchamp, Miriam; Craig, William; Doan, Quynh; Zemek, Roger; Bjornson, Bruce H; Gravel, Jocelyn; Mikrogianakis, Angelo; Goodyear, Bradley; Abdeen, Nishard; Beaulieu, Christian; Dehaes, Mathieu; Deschenes, Sylvain; Harris, Ashley; Lebel, Catherine; Lamont, Ryan; Williamson, Tyler; Barlow, Karen Maria; Bernier, Francois; Brooks, Brian L; Emery, Carolyn; Freedman, Stephen B; Kowalski, Kristina; Mrklas, Kelly; Tomfohr-Madsen, Lianne; Schneider, Kathryn J

2017-01-01

Introduction Paediatric mild traumatic brain injury (mTBI) is a public health burden. Clinicians urgently need evidence-based guidance to manage mTBI, but gold standards for diagnosing and predicting the outcomes of mTBI are lacking. The objective of the Advancing Concussion Assessment in Pediatrics (A-CAP) study is to assess a broad pool of neurobiological and psychosocial markers to examine associations with postinjury outcomes in a large sample of children with either mTBI or orthopaedic injury (OI), with the goal of improving the diagnosis and prognostication of outcomes of paediatric mTBI. Methods and analysis A-CAP is a prospective, longitudinal cohort study of children aged 8.00–16.99 years with either mTBI or OI, recruited during acute emergency department (ED) visits at five sites from the Pediatric Emergency Research Canada network. Injury information is collected in the ED; follow-up assessments at 10 days and 3 and 6 months postinjury measure a variety of neurobiological and psychosocial markers, covariates/confounders and outcomes. Weekly postconcussive symptom ratings are obtained electronically. Recruitment began in September 2016 and will occur for approximately 24 months. Analyses will test the major hypotheses that neurobiological and psychosocial markers can: (1) differentiate mTBI from OI and (2) predict outcomes of mTBI. Models initially will focus within domains (eg, genes, imaging biomarkers, psychosocial markers), followed by multivariable modelling across domains. The planned sample size (700 mTBI, 300 OI) provides adequate statistical power and allows for internal cross-validation of some analyses. Ethics and dissemination The ethics boards at all participating institutions have approved the study and all participants and their parents will provide informed consent or assent. Dissemination will follow an integrated knowledge translation plan, with study findings presented at scientific conferences and in multiple manuscripts in peer-reviewed journals. PMID:28710227

A descriptive longitudinal study protocol: recurrence and pregnancy post-repair of obstetric fistula in Guinea.

PubMed

Delamou, Alexandre; Delvaux, Therese; Beavogui, Abdoul Habib; Levêque, Alain; Zhang, Wei-Hong; De Brouwere, Vincent

2016-10-10

Obstetric fistula is a serious medical condition which affects women in low income countries. Despite the progress of research on fistula, there is little data on long term follow-up after surgical repair. The objective of this study is to analyse the factors associated with the recurrence of fistula and the outcomes of pregnancy following fistula repair in Guinea. A descriptive longitudinal study design will be used. The study will include women who underwent fistula repair between 2012 and 2015 at 3 fistula repair sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé Regional Hospital and Jean Paul II Hospital of Conakry). Participants giving an informed consent after a home visit by the Fistula Counsellors will be interviewed for enrolment at least 3 months after hospital discharge The study enrolment period is January 1, 2012 - June 30, 2015. Participants will be followed-up until June 30, 2016 for a maximum follow up period of 48 months. The sample size is estimated at 364 women. The cumulative incidence rates of fistula recurrence and pregnancy post-repair will be calculated using Kaplan-Meier methods and the risk factor analyses will be performed using adjusted Cox regression. The outcomes of pregnancy will be analysed using proportions, the Pearson's Chi Square (χ2) and a logistic regression with associations reported as risk ratios with 95 % confidence intervals. All analyses will be done using STATA version 13 (STATA Corporation, College Station, TX, USA) with a level of significance set at P < 0.05. This study will contribute to improving the prevention and management of obstetric fistula within the community and support advocacy efforts for the social reintegration of fistula patients into their communities. It will also guide policy makers and strategic planning for fistula programs. ClinicalTrials.gov Identifier: NCT02686957 . Registered 12 February 2016 (Retrospectively registered).

Protocol for a prospective longitudinal study of risk factors for hypertension incidence in a Mexico City population: the Tlalpan 2020 cohort.

PubMed

Colín-Ramírez, Eloisa; Rivera-Mancía, Susana; Infante-Vázquez, Oscar; Cartas-Rosado, Raúl; Vargas-Barrón, Jesús; Madero, Magdalena; Vallejo, Maite

2017-07-31

Systemic hypertension (HTN) is a common risk factor for cardiovascular disease. In Mexico, HTN prevalence has increased over time and is currently 31%. Nonetheless, information about the country's HTN incidence and its associated risk factors is scarce. Understanding this condition is a priority for identifying the scope of primary prevention. The main objective of this study is to evaluate the effect of traditional and non-traditional risk factors on the incidence of HTN in a cohort of healthy Mexico City residents under biannual follow-up for 10 years. A prospective longitudinal study is proposed in which clinically healthy residents of Mexico City between 20 and 50 years old will be recruited; the participants will be evaluated every 2 years over a period of 10 years or until they develop HTN. Evaluations regarding sociodemographic, clinical, anthropometric, biochemical, diet, physical activity, stress, sleep quality, alcohol and tobacco consumption factors will be performed. The participants will be recruited from the 16 municipalities of Mexico City through promotional strategies aimed at the community and will be clinically evaluated at a tertiary care institution, Instituto Nacional de Cardiología Ignacio Chávez (National Institute of Cardiology Ignacio Chavez), located in Mexico City, Mexico. Sample size estimated for this study is 3436, and the Cox proportional hazards model will be used to estimate HRs for the association between explanatory variables and HTN using both raw and adjusted data. This study was approved by the Institutional Bioethics Committee of the Instituto Nacional de Cardiología Ignacio Chávez (National Institute of Cardiology Ignacio Chavez) under number 13-802. Findings from this study will be disseminated through scientific papers and research conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A recall-by-genotype study of CHRNA5-A3-B4 genotype, cotinine and smoking topography: study protocol.

PubMed

Ware, Jennifer J; Timpson, Nic; Davey Smith, George; Munafò, Marcus R

2014-01-22

Genome-wide association studies have revealed an association between several loci in the nicotinic acetylcholine receptor gene cluster CHRNA5-A3-B4 and daily cigarette consumption. Recent studies have sought to refine this phenotype, and have shown that a locus within this cluster, marked primarily by rs1051730 and rs16969968, is also associated with levels of cotinine, the primary metabolite of nicotine. This association remains after adjustment for self-reported smoking, which suggests that even amongst people who smoke the same number of cigarettes there is still genetically-influenced variation in nicotine consumption. This is likely to be due to differences in smoking topography, that is, how a cigarette is smoked (e.g., volume of smoke inhaled per puff, number of puffs taken per cigarette). The aim of this study is to determine potential mediation of the relationship between the rs1051730 locus and cotinine levels by smoking topography. Adopting a recall-by-genotype design, we will recruit 200 adults from the Avon Longitudinal Study of Parents and Children on the basis of minor or major homozygote status at rs1051730 (100 in each genotype group). All participants will be current, daily smokers. Our primary study outcome measures will be measures of smoking topography: total volume of smoke (ml) inhaled per cigarette, total volume of smoke (ml) inhaled over of the course of one day, and salivary cotinine level (ng/ml). This study will extend our understanding of the biological basis of inter-individual variability in heaviness of smoking, and therefore in exposure to smoking-related toxins. The novel recall-by-genotype approach we will use is efficient, maximising statistical power, and enables the collection of extremely precise phenotypic data that are impractical to collect in a larger sample. The methods described within this protocol also hold the potential for wider application in the field of molecular genetics.

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR NONCLINICAL LABORATORY STUDIES Protocol for and Conduct of a Nonclinical Laboratory Study § 58.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following...

Interdisciplinary care in disorders/differences of sex development (DSD): The psychosocial component of the DSD-Translational research network.

PubMed

Sandberg, David E; Gardner, Melissa; Callens, Nina; Mazur, Tom

2017-06-01

Scientific discovery and clinical management strategies for Disorders/Differences of Sex Development (DSD) have advanced in recent years. The 2006 Consensus Statement on Management of Intersex Disorders stated that a mental health component to care is integral to promote positive adaptation, yet the parameters of this element have not been described. The objective of this paper is threefold: to describe the psychosocial screening protocol adopted by the clinical centers of the DSD-Translational Research Network; to summarize psychosocial data collected at 1 of the 10 network sites; and to suggest how systematic behavioral health screenings can be employed to tailor care in DSD that results in better health and quality of life outcomes. Steps taken in developing the largely "noncategorical" screening protocol are described. These preliminary findings suggest that DSD, as one category of pediatric chronic conditions, is not associated with marked disturbances of psychosocial adaptation, either for the family or the child; however, screening frequently uncovered "risk factors" for individual families or patients that can potentially be addressed in the context of ongoing clinical care. Administration of the DSD-TRN psychosocial screening protocol was demonstrated to be feasible in the context of interdisciplinary team care and was acceptable to families on a longitudinal basis. The ultimate value of systematic screening will be demonstrated through a tailoring of psychosocial, medical and surgical services, based on this information that enhances the quality of patient and family-centered care and subsequent outcomes. © 2017 Wiley Periodicals, Inc.

Adaptive Quantification and Longitudinal Analysis of Pulmonary Emphysema with a Hidden Markov Measure Field Model

PubMed Central

Häme, Yrjö; Angelini, Elsa D.; Hoffman, Eric A.; Barr, R. Graham; Laine, Andrew F.

2014-01-01

The extent of pulmonary emphysema is commonly estimated from CT images by computing the proportional area of voxels below a predefined attenuation threshold. However, the reliability of this approach is limited by several factors that affect the CT intensity distributions in the lung. This work presents a novel method for emphysema quantification, based on parametric modeling of intensity distributions in the lung and a hidden Markov measure field model to segment emphysematous regions. The framework adapts to the characteristics of an image to ensure a robust quantification of emphysema under varying CT imaging protocols and differences in parenchymal intensity distributions due to factors such as inspiration level. Compared to standard approaches, the present model involves a larger number of parameters, most of which can be estimated from data, to handle the variability encountered in lung CT scans. The method was used to quantify emphysema on a cohort of 87 subjects, with repeated CT scans acquired over a time period of 8 years using different imaging protocols. The scans were acquired approximately annually, and the data set included a total of 365 scans. The results show that the emphysema estimates produced by the proposed method have very high intra-subject correlation values. By reducing sensitivity to changes in imaging protocol, the method provides a more robust estimate than standard approaches. In addition, the generated emphysema delineations promise great advantages for regional analysis of emphysema extent and progression, possibly advancing disease subtyping. PMID:24759984

Postfatigue potentiation of the paralyzed soleus muscle: evidence for adaptation with long-term electrical stimulation training

PubMed Central

Shields, Richard K.; Dudley-Javoroski, Shauna; Littmann, Andrew E.

2012-01-01

Understanding the torque output behavior of paralyzed muscle has important implications for the use of functional neuromuscular electrical stimulation systems. Postfatigue potentiation is an augmentation of peak muscle torque during repetitive activation after a fatigue protocol. The purposes of this study were 1) to quantify postfatigue potentiation in the acutely and chronically paralyzed soleus and 2) to determine the effect of long-term soleus electrical stimulation training on the potentiation characteristics of recently paralyzed soleus muscle. Five subjects with chronic paralysis (>2 yr) demonstrated significant postfatigue potentiation during a repetitive soleus activation protocol that induced low-frequency fatigue. Ten subjects with acute paralysis (<6 mo) demonstrated no torque potentiation in response to repetitive stimulation. Seven of these acute subjects completed 2 yr of home-based isometric soleus electrical stimulation training of one limb (compliance = 83%; 8,300 contractions/wk). With the early implementation of electrically stimulated training, potentiation characteristics of trained soleus muscles were preserved as in the acute postinjury state. In contrast, untrained limbs showed marked postfatigue potentiation at 2 yr after spinal cord injury (SCI). A single acute SCI subject who was followed longitudinally developed potentiation characteristics very similar to the untrained limbs of the training subjects. The results of the present investigation support that postfatigue potentiation is a characteristic of fast-fatigable muscle and can be prevented by timely neuromuscular electrical stimulation training. Potentiation is an important consideration in the design of functional electrical stimulation control systems for people with SCI. PMID:16575026

Postfatigue potentiation of the paralyzed soleus muscle: evidence for adaptation with long-term electrical stimulation training.

PubMed

Shields, Richard K; Dudley-Javoroski, Shauna; Littmann, Andrew E

2006-08-01

Understanding the torque output behavior of paralyzed muscle has important implications for the use of functional neuromuscular electrical stimulation systems. Postfatigue potentiation is an augmentation of peak muscle torque during repetitive activation after a fatigue protocol. The purposes of this study were 1) to quantify postfatigue potentiation in the acutely and chronically paralyzed soleus and 2) to determine the effect of long-term soleus electrical stimulation training on the potentiation characteristics of recently paralyzed soleus muscle. Five subjects with chronic paralysis (>2 yr) demonstrated significant postfatigue potentiation during a repetitive soleus activation protocol that induced low-frequency fatigue. Ten subjects with acute paralysis (<6 mo) demonstrated no torque potentiation in response to repetitive stimulation. Seven of these acute subjects completed 2 yr of home-based isometric soleus electrical stimulation training of one limb (compliance = 83%; 8,300 contractions/wk). With the early implementation of electrically stimulated training, potentiation characteristics of trained soleus muscles were preserved as in the acute postinjury state. In contrast, untrained limbs showed marked postfatigue potentiation at 2 yr after spinal cord injury (SCI). A single acute SCI subject who was followed longitudinally developed potentiation characteristics very similar to the untrained limbs of the training subjects. The results of the present investigation support that postfatigue potentiation is a characteristic of fast-fatigable muscle and can be prevented by timely neuromuscular electrical stimulation training. Potentiation is an important consideration in the design of functional electrical stimulation control systems for people with SCI.

The implementation of game in a 20-day head-down tilting bed rest experiment upon mood status and neurotic levels of rest subjects

NASA Astrophysics Data System (ADS)

Ishizaki, Yuko; Fukuoka, Hideoki; Ishizaki, Tatsuro; Tanaka, Hidetaka; Ishitobi, Hiromi

2004-12-01

This study evaluated the effect of the implementation of game on mental health among participants in a bed rest (BR) experiment. Subjects were 12 healthy males aged 20-26, who participated in a 20-day 6-degrees head-down tilting BR experiment. The participants were asked to complete psychometrical questionnaires before, during, and after the experiment. We entrusted the participants to manage their leisure time and they intended a game in which all of them could take part over the experiment period. The general conversation and light-hearted mood among the subjects continued during the experimental period. Longitudinal data analysis showed that levels of neurosis and mood status did not deteriorate during the experiment, while our previous experiments, which were performed under the same protocol as this study except for the implementation of the game showed a distinct deterioration in psychosocial status. We consider that the implementation of game autonomously contributes to the positive effects on the mental health among the participants.

Colorado Longitudinal Twin Study of Reading Disability

ERIC Educational Resources Information Center

Wadsworth, Sally J.; DeFries, John C.; Olson, Richard K.; Willcutt, Erik G.

2007-01-01

The primary objectives of the present study are to introduce the Colorado Longitudinal Twin Study of Reading Disability, the first longitudinal twin study in which subjects have been specifically selected for having a history of reading difficulties, and to present some initial assessments of the stability of reading performance and cognitive…

76 FR 65187 - Notice of Proposed Information Collection Requests

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... careers. This study includes a new student assessment in algebraic skills, reasoning, and problem solving... School Longitudinal Study of 2009 (HSLS:09) High School Transcript Collection and College Update Field... Longitudinal Study of 2009 (HSLS:09) is a nationally representative, longitudinal study of more than 20,000...

Quality of Documentation as a Surrogate Marker for Awareness and Training Effectiveness of PHTLS-Courses. Part of the Prospective Longitudinal Mixed-Methods EPPTC-Trial.

PubMed

Häske, David; Beckers, Stefan K; Hofmann, Marzellus; Lefering, Rolf; Gliwitzky, Bernhard; Wölfl, Christoph C; Grützner, Paul; Stöckle, Ulrich; Dieroff, Marc; Münzberg, Matthias

2017-01-01

Care for severely injured patients requires multidisciplinary teamwork. A decrease in the number of accident victims ultimately affects the routine and skills. PHTLS ("Pre-Hospital Trauma Life Support") courses are established two-day courses for medical and non-medical rescue service personnel, aimed at improving the pre-hospital care of trauma patients worldwide. The study aims the examination of the quality of documentation before and after PHTLS courses as a surrogate endpoint of training effectiveness and awareness. This was a prospective pre-post intervention trial and was part of the mixed-method longitudinal EPPTC (Effect of Paramedic Training on Pre-Hospital Trauma Care) study, evaluating subjective and objective changes among participants and real patient care, as a result of PHTLS courses. The courses provide an overview of the SAMPLE approach for interrogation of anamnestic information, which is believed to be responsible for patient safety as relevant, among others, "Allergies," "Medication," and "Patient History" (AMP). The focus of the course is not the documentation. In total, 320 protocols were analyzed before and after the training. The PHTLS course led to a significant increase (p < 0.001) in the "AMP" information in the documentation. The subgroups analysis of "allergies" (+47.2%), "drugs" (+38.1%), and "medical history" (+27.8%) before and after the PHTLS course showed a significant increase in the information content. In summary, we showed that PHTLS training improves documentation quality, which we used as a surrogate endpoint for learning effectiveness and awareness. In this regard, we demonstrated that participants use certain parts of training in real life, thereby suggesting that the learning methods of PHTLS training are effective. These results, however, do not indicate whether patient care has changed.

Reproducibility and interoperator reliability of obtaining images and measurements of the cervix and uterus with brachytherapy treatment applicators in situ using transabdominal ultrasound.

PubMed

van Dyk, Sylvia; Garth, Margaret; Oates, Amanda; Kondalsamy-Chennakesavan, Srinivas; Schneider, Michal; Bernshaw, David; Narayan, Kailash

2016-01-01

To validate interoperator reliability of brachytherapy radiation therapists (RTs) in obtaining an ultrasound image and measuring the cervix and uterine dimensions using transabdominal ultrasound. Patients who underwent MRI with applicators in situ after the first insertion were included in the study. Imaging was performed by three RTs (RT1, RT2, and RT3) with varying degrees of ultrasound experience. All RTs were required to obtain a longitudinal planning image depicting the applicator in the uterine canal and measure the cervix and uterus. The MRI scan, taken 1 hour after the ultrasound, was used as the reference standard against which all measurements were compared. Measurements were analyzed with intraclass correlation coefficient and Bland-Altman plots. All RTs were able to obtain a suitable longitudinal image for each patient in the study. Mean differences (SD) between MRI and ultrasound measurements obtained by RTs ranged from 3.5 (3.6) to 4.4 (4.23) mm and 0 (3.0) to 0.9 (2.5) mm on the anterior and posterior surface of the cervix, respectively. Intraclass correlation coefficient for absolute agreement between MRI and RTs was >0.9 for all posterior measurement points in the cervix and ranged from 0.41 to 0.92 on the anterior surface. Measurements were not statistically different between RTs at any measurement point. RTs with variable training attained high levels of interoperator reliability when using transabdominal ultrasound to obtain images and measurements of the uterus and cervix with brachytherapy applicators in situ. Access to training and use of a well-defined protocol assist in achieving these high levels of reliability. Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

STroke imAging pRevention and treatment (START): A longitudinal stroke cohort study: Clinical trials protocol.

PubMed

Carey, Leeanne M; Crewther, Sheila; Salvado, Olivier; Lindén, Thomas; Connelly, Alan; Wilson, William; Howells, David W; Churilov, Leonid; Ma, Henry; Tse, Tamara; Rose, Stephen; Palmer, Susan; Bougeat, Pierrick; Campbell, Bruce C V; Christensen, Soren; Macaulay, S Lance; Favaloro, Jenny; O' Collins, Victoria; McBride, Simon; Bates, Susan; Cowley, Elise; Dewey, Helen; Wijeratne, Tissa; Gerraty, Richard; Phan, Thanh G; Yan, Bernard; Parsons, Mark W; Bladin, Chris; Barber, P Alan; Read, Stephen; Wong, Andrew; Lee, Andrew; Kleinig, Tim; Hankey, Graeme J; Blacker, David; Markus, Romesh; Leyden, James; Krause, Martin; Grimley, Rohan; Mahant, Neil; Jannes, Jim; Sturm, Jonathan; Davis, Stephen M; Donnan, Geoffrey A

2015-06-01

Stroke and poststroke depression are common and have a profound and ongoing impact on an individual's quality of life. However, reliable biological correlates of poststroke depression and functional outcome have not been well established in humans. Our aim is to identify biological factors, molecular and imaging, associated with poststroke depression and recovery that may be used to guide more targeted interventions. In a longitudinal cohort study of 200 stroke survivors, the START-STroke imAging pRevention and Treatment cohort, we will examine the relationship between gene expression, regulator proteins, depression, and functional outcome. Stroke survivors will be investigated at baseline, 24 h, three-days, three-months, and 12 months poststroke for blood-based biological associates and at days 3-7, three-months, and 12 months for depression and functional outcomes. A sub-group (n = 100), the PrePARE: Prediction and Prevention to Achieve optimal Recovery Endpoints after stroke cohort, will also be investigated for functional and structural changes in putative depression-related brain networks and for additional cognition and activity participation outcomes. Stroke severity, diet, and lifestyle factors that may influence depression will be monitored. The impact of depression on stroke outcomes and participation in previous life activities will be quantified. Clinical significance lies in the identification of biological factors associated with functional outcome to guide prevention and inform personalized and targeted treatments. Evidence of associations between depression, gene expression and regulator proteins, functional and structural brain changes, lifestyle and functional outcome will provide new insights for mechanism-based models of poststroke depression. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Prevalence of Periodontal Diseases in a Multicenter Cohort of Perinatally HIV-Infected and HIV-exposed and Uninfected Youth

PubMed Central

Ryder, Mark I.; Yao, Tzy-Jyun; Russell, Jonathan S.; Moscicki, Anna-Barbara; Shiboski, Caroline H.

2016-01-01

Aims To compare the prevalence and severity of periodontal diseases between 180 perinatally HIV-infected (PHIV) and 118 perinatally HIV-exposed and uninfected (PHEU) youth in a cross-sectional study conducted at 11 clinical sites in the United States and Puerto Rico from the Adolescent Master Protocol (AMP) study of the Pediatric HIV/AIDS cohort study (PHACS) network. Methods Several analyses were conducted, employing the current CDC/AAP classification for periodontitis and incorporating a definition of gingivitis based on a bleeding on probing threshold, and analyses based on more detailed whole mouth, intraoral regionally, site-based, and tooth-based criteria of bleeding on probing, plaque levels, pockets depths and clinical attachment levels. Results After adjusting for plaque control habits, and behavioral and sociodemographic factors, there were no significant differences in periodontal diseases between the PHIV and PHEU youth using any of these criteria. For PHIV youth, there was no significant association between parameters of periodontal disease and current HIV status. Conclusions While no significant differences in periodontal parameters were noted between the PHIV and PHEU youth, the influence of antiretroviral therapy on merits further exploration in this cohort in a longitudinal study. PMID:27801947

A Platform to Monitor Tumor Cellular and Vascular Response to Radiation Therapy by Optical Coherence Tomography and Fluorescence Microscopy in vivo

NASA Astrophysics Data System (ADS)

Leung, Michael Ka Kit

Radiotherapy plays a significant role in cancer treatment, and is thought to be curative by mainly killing tumor cells through damage to their genetic material. However, recent findings indicate that the tumor's vascular blood supply is also a major determinant of radiation response. The goals of this thesis are to: (1) develop an experimental platform for small animals to deliver ionizing radiation and perform high-resolution optical imaging to treatment targets, and (2) use this toolkit to longitudinally monitor the response of tumors and the associated vasculature. The thesis has achieved: (1) customization of a novel micro-irradiator for mice, (2) technical development of an improved optical coherence tomography imaging system, (3) comprehensive experimental protocol and imaging optimization for optical microscopy in a specialized animal model, and (4) completion of a feasibility study to demonstrate the capabilities of the experimental platform in monitoring the response of tumor and vasculature to radiotherapy.

Breaking up is hard to do: Women's experience of dissolving their same-sex relationship.

PubMed

Balsam, Kimberly F; Rostosky, Sharon S; Riggle, Ellen D B

2017-01-02

While prior research has compared same-sex to heterosexual relationships, very little attention has been paid to the unique experiences of women dissolving same-sex relationships, especially in the context of shifting legal and social policies. The current study examined the experience of 20 women who dissolved their same-sex relationship between 2002 and 2014. Participants were drawn from a longitudinal sample of same-sex and heterosexual couples and were interviewed using a semi-structured protocol. Interviews focused on three primary research questions: reasons for dissolution, emotional reactions, and role of legal status. While reasons for dissolution largely mirrored literature on women in heterosexual relationships, emotional reactions and the role of legal status were both influenced by sexual minority-specific factors related to minority stress and the recent societal changes pertaining to legal relationship recognition. Results are interpreted in a framework of minority stress and the ongoing legacy of institutional discrimination experienced by women in same-sex relationships.

Micro/nano-computed tomography technology for quantitative dynamic, multi-scale imaging of morphogenesis.

PubMed

Gregg, Chelsea L; Recknagel, Andrew K; Butcher, Jonathan T

2015-01-01

Tissue morphogenesis and embryonic development are dynamic events challenging to quantify, especially considering the intricate events that happen simultaneously in different locations and time. Micro- and more recently nano-computed tomography (micro/nanoCT) has been used for the past 15 years to characterize large 3D fields of tortuous geometries at high spatial resolution. We and others have advanced micro/nanoCT imaging strategies for quantifying tissue- and organ-level fate changes throughout morphogenesis. Exogenous soft tissue contrast media enables visualization of vascular lumens and tissues via extravasation. Furthermore, the emergence of antigen-specific tissue contrast enables direct quantitative visualization of protein and mRNA expression. Micro-CT X-ray doses appear to be non-embryotoxic, enabling longitudinal imaging studies in live embryos. In this chapter we present established soft tissue contrast protocols for obtaining high-quality micro/nanoCT images and the image processing techniques useful for quantifying anatomical and physiological information from the data sets.

Individualized dry-land intervention program for an élite Paralympic swimmer: a case report.

PubMed

Cavaggioni, Luca; Trecroci, Athos; Tosin, Massimiliano; Iaia, F Marcello; Alberti, Giampietro

2018-03-01

The aim of this retrospective case study is the longitudinal description of the physical and functional parameters of a top-level Paralympic swimmer class S9-SB8-SM9 during four swimming seasons of training, from the Paralympic games in London 2012 to the Paralympic games in Rio 2016. A 22-year-old male swimmer underwent a specific preventive dry-land training based on diaphragmatic breathing, postural alignment, and slow-velocity resistance training aimed to improve his muscle strength. He was tested by using the Functional Movement ScreenTM, photographic postural assessment and vertical jump. The swimmer improved his functional, postural and strength parameters indicating a better functional movement and muscular power. These results shows that a four-year specific dry-land intervention could be capable of enhancing the functional and physical requirements of a top-level Paralympic swimmer. This approach might be a suitable novel alternative for physical therapists and athletic trainers to integrate their training protocols for athletes with similar impairments.

Neutral endopeptidase (NEP) and its role in pathological pulmonary change with inhalation exposure to JP-8 jet fuel.

PubMed

Pfaff, J K; Tollinger, B J; Lantz, R C; Chen, H; Hays, A M; Witten, M L

1996-01-01

Through a simulated flightline exposure protocol, Fischer 344 rats (F344) were subjected to an aerosol/vapor mix of the military jet fuel, JP-8. Previous studies with this model of lung injury have revealed significant increases in pulmonary resistance, increased alveolar clearance of 99mTcDTPA, and a decrease in bronchoalveolar lavage fluid (BALF) concentration of the neuropeptide substance P (SP). Exposures to JP-8 were nose-only and for one hour daily. Six groups of Fischer 344 rats were exposed for 7, 28, or 56 days at two JP-8 concentrations (low dose = 469-520 mg/m3/hr, high dose = 814-1263 mg/m3/hr). Exposed groups were matched with longitudinal controls. In response to JP-8 inhalation, exposure animals demonstrated a dose-dependent as well as duration-determined reduction in BALF SP concentration. Both JP-8 concentrations caused significant pathological changes in lower pulmonary structures.

The influence of biological and technical factors on quantitative analysis of amyloid PET: Points to consider and recommendations for controlling variability in longitudinal data.

PubMed

Schmidt, Mark E; Chiao, Ping; Klein, Gregory; Matthews, Dawn; Thurfjell, Lennart; Cole, Patricia E; Margolin, Richard; Landau, Susan; Foster, Norman L; Mason, N Scott; De Santi, Susan; Suhy, Joyce; Koeppe, Robert A; Jagust, William

2015-09-01

In vivo imaging of amyloid burden with positron emission tomography (PET) provides a means for studying the pathophysiology of Alzheimer's and related diseases. Measurement of subtle changes in amyloid burden requires quantitative analysis of image data. Reliable quantitative analysis of amyloid PET scans acquired at multiple sites and over time requires rigorous standardization of acquisition protocols, subject management, tracer administration, image quality control, and image processing and analysis methods. We review critical points in the acquisition and analysis of amyloid PET, identify ways in which technical factors can contribute to measurement variability, and suggest methods for mitigating these sources of noise. Improved quantitative accuracy could reduce the sample size necessary to detect intervention effects when amyloid PET is used as a treatment end point and allow more reliable interpretation of change in amyloid burden and its relationship to clinical course. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Longitudinal impact of interprofessional education on attitudes, skills and career trajectories: a protocol for a quasi­experimental study in New Zealand

PubMed Central

Darlow, Ben; Brown, Melanie; Gallagher, Peter; Gray, Lesley; McKinlay, Eileen; Purdie, Gordon; Wilson, Christine; Pullon, Sue

2018-01-01

Introduction Interprofessional practice is recognised as an important element of safe and effective healthcare. However, few studies exist that evaluate how preregistration education contributes to interprofessional competencies, and how these competencies develop throughout the early years of a health professional’s career. This quasiexperimental study will gather longitudinal data during students’ last year of preregistration training and their first 3 years of professional practice to evaluate the ongoing development of interprofessional competencies and the influence that preregistration education including an explicit interprofessional education (IPE) programme may have on these. Methods and analysis Participants are students and graduates from the disciplines of dentistry, dietetics, medicine, nursing, occupational therapy, oral health, pharmacy and physiotherapy recruited before their final year of study. A subset of these students attended a 5-week IPE immersion programme during their final year of training. All data will be collected via five written or electronic surveys completed at 12-month intervals. Each survey will contain the Attitudes Towards Health Care Teams Scale and the Team Skills Scale, as well as quantitative and free-text items to explore vocational satisfaction, career trajectories and influences on these. Students who attend the IPE programme will complete additional free-text items to explore the effects of this programme on their careers. Quantitative analysis will compare scores at each time point, adjusted for baseline scores, for graduates who did and did not participate in the IPE programme. Associations between satisfaction data and discipline, professional setting, location and IPE participation will also be examined. Template analysis will explore free-text themes related to influences on career choices including participation in preregistration IPE. Ethics and dissemination This study has received approval from the University of Otago Ethics Committee (D13/019). Results will be disseminated through peer-reviewed publications, conferences and stakeholder reports. Findings will inform future IPE developments and health workforce planning. PMID:29358432

Progress in the implementation of Quality Management in Dutch health care: 1995-2000.

PubMed

Sluijs, Emmy M; Wagner, Cordula

2003-06-01

Policymakers and researchers in all countries like to know whether the implementation of Quality Management (QM) in health care is proceeding satisfactorily. Longitudinal surveys can reveal whether sufficient progress is being made. The main objective of the study was to investigate the progress in QM in Dutch health care organizations during the period 1995-2000. A second objective was to explore whether the progress in QM was related to subsectors of care and/or to cultural characteristics of health care organizations. The study has a descriptive longitudinal design, based on repeat measurements in 1995 and 2000. Empirical data about QM activities in health care organizations were gathered using a questionnaire. The analyses are based on data from the 474 health care organizations that participated in the study in 1995 and 2000. Participants in the study were organizations from all subsectors of health care, including providers of home care, nursing homes, hospitals, and other care sectors. Outcome measures are 46 distinct QM activities, which were listed in the questionnaire. Two-thirds of the organizations had made progress in the implementation of QM activities. A mean of 25 QM activities per organization was found in 2000 compared with 20 in 1995. More care providers had set up a client council and had carried out patient satisfaction surveys. Home care organizations had made twice as much progress as many other health care organizations. However, nearly one-third of the health care organizations showed a decline in QM activities. Patient organizations were less often involved in the development of quality criteria and protocols. Progress in QM was weakly related to the dedicated and flexible attitude of employees and a non-hierarchical decision-making structure. The study demonstrates that the implementation of QM activities can be monitored at the national level and that differences between subsectors of care can be assessed. The decline in QM activities in one-third of the organizations needs to be researched further.

Leveraging ongoing research to evaluate the health impacts of South Africa's salt reduction strategy: a prospective nested cohort within the WHO-SAGE multicountry, longitudinal study

PubMed Central

Charlton, Karen; Menyanu, Elias; Biritwum, Richard Berko; Naidoo, Nirmala; Pieterse, Chiné; Madurai, Savathree (Lorna); Baumgartner, Jeannine; Asare, George A; Thiele, Elizabeth; Schutte, Aletta E; Kowal, Paul

2016-01-01

Introduction Attempting to curb the rising epidemic of hypertension, South Africa implemented legislation in June 2016 mandating maximum sodium levels in a range of manufactured foods that contribute significantly to population salt intake. This natural experiment, comparing two African countries with and without salt legislation, will provide timely information on the impact of legislative approaches addressing the food supply to improve blood pressure in African populations. This article outlines the design of this ongoing prospective nested cohort study. Methods and analysis Baseline sodium intake was assessed in a nested cohort of the WHO Study on global AGEing and adult health (WHO-SAGE) wave 2 (2014–2015), a multinational longitudinal study on the health and well-being of adults and the ageing process. The South African cohort consisted of randomly selected households (n=4030) across the country. Spot and 24-hour urine samples are collected in a random subsample (n=1200) and sodium, potassium, creatinine and iodine analysed. Salt behaviour and sociodemographic data are captured using face-to-face interviews, alongside blood pressure and anthropometric measures. Ghana, the selected control country with no formal salt policy, provided a nested subsample (n=1200) contributing spot and 24-hour urine samples from the SAGE Ghana cohort (n=5000). Follow-up interviews and urine collection (wave 3) in both countries will take place in 2017 (postlegislation) to assess change in population-level sodium intake and blood pressure. Ethics and dissemination SAGE was approved by the WHO Ethics Review Committee (reference number RPC149) with local approval from the North-West University Human Research Ethics Committee and University of the Witwatersrand Human Research Ethics Committee (South Africa), and University of Ghana Medical School Ethics and Protocol Review Committee (Ghana). The results of the study will be published in peer-reviewed international journals, presented at national and international conferences, and summarised as research and policy briefs. PMID:27903563

Protocol of the Swiss Longitudinal Cohort Study (SWICOS) in rural Switzerland

PubMed Central

Schoenenberger, Andreas W; Muggli, Franco; Parati, Gianfranco; Gallino, Augusto; Ehret, Georg; Suter, Paolo M; Schoenenberger-Berzins, Renate; Resink, Therese J; Erne, Paul

2016-01-01

Introduction Increased longevity and consequent major changes in demographics and population lifestyles necessitate new approaches to reduce the burden of ageing-related diseases (including cardiovascular disease) and maintain an optimal quality of life. This study aims to examine and longitudinally follow health status and disease risk factors in a Swiss rural cohort, evaluating all health-related research and practice disciplines to assure development of new implementable and successful preventive strategies for healthy ageing. Methods and objectives Small Swiss villages with low migration rates will be selected for this study. 2 villages (Cama/Lostallo) have already been selected as initial study sites. All residents (age ≥6 years, no upper age limit) are eligible. The target enrolment number per village is 300. Examinations and measurements encompass medical history, anthropometry, cardiac and vascular health, pulmonary function, physical performance, nutritional, mental and emotional status, biochemical and molecular analyses. Follow-up examinations (identical to baseline) will be performed after 5 and 10 years, and in 10-year intervals thereafter. The major objective is to assess, and observe change in, health status over time in a prospective manner. Secondary objectives are to: (1) identify ‘hidden’ (asymptomatic and/or unrecognised) health problems which enhance risk for chronic diseases; (2) identify barriers to accessing healthcare and adapting health behaviours; (3) evaluate efficacy of present preventive strategies and recommendations; (4) evaluate knowledge and attitude towards ongoing health programmes and public health recommendations; (5) monitor change and progress towards the national health objectives; (6) formulate new preventive strategies and recommendations based on the findings and knowledge base of the past 10 years; (7) formulate models for successful prevention of chronic diseases and for healthy ageing. Ethics and dissemination The Ethics Committee of Nordwest-und Zentralschweiz approved this study (EKNZ 2014-209). It is registered at ClinicalTrials.gov (NCT02282748). Findings will be disseminated through scientific articles/presentations and public events. PMID:27895066

Study protocol of the internet user Cohort for Unbiased Recognition of gaming disorder in Early adolescence (iCURE), Korea, 2015–2019

PubMed Central

Jeong, Hyunsuk; Jo, Sun-Jin; Lee, Seung-Yup; Kim, Eunjin; Son, Hye Jung; Han, Hyun-ho; Lee, Hae Kook; Kweon, Yong-Sil; Bhang, Soo-young; Choi, Jung-Seok; Kim, Bung-Nyun; Gentile, Douglas A; Potenza, Marc N

2017-01-01

Introduction In 2013, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) proposed nine internet gaming disorder (IGD) diagnostic criteria as a condition warranting further empirical and clinical research. The aim of this study is to clarify the natural and clinical courses of IGD proposed DSM-5 in adolescents and to evaluate its risk and protective factors. Methods and analysis The Internet user Cohort for Unbiased Recognition of gaming disorder in Early Adolescence (iCURE) study is an ongoing multidisciplinary, prospective, longitudinal cohort study conducted in 21 schools in Korea. Participant recruitment commenced in March 2015 with the goal of registering 3000 adolescents. The baseline assessment included surveys on emotional, social and environmental characteristics. A parent or guardian completed questionnaires and a structured psychiatric comorbidity diagnostic interview regarding their children. Adolescents with the Internet Game Use-Elicited Symptom Screen total scores of 6 or higher were asked to participate in the clinical diagnostic interview. Two subcohorts of adolescents were constructed: a representative subcohort and a clinical evaluation subcohort. The representative subcohort comprises a randomly selected 10% of the iCURE to investigate the clinical course of IGD based on clinical diagnosis and to estimate the false negative rate. The clinical evaluation subcohort comprised participants meeting three or more of the nine IGD criteria, determined by clinical diagnostic interview, to show the clinical course of IGD. Follow-up data will be collected annually for the 3 years following the baseline assessments. The primary endpoint is 2-year incidence, remission and recurrence rates of IGD. Cross-sectional and longitudinal associations between exposures and outcomes as well as mediation factors will be evaluated. Ethics and dissemination This study is approved by the Institutional Review Board of the Catholic University of Korea. Results will be published in peer-reviewed journals. Trial registration number ClinicalTrials.gov (identifier: NCT02415322). PMID:28982839

InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients - the LIAISON study protocol

PubMed Central

2013-01-01

Background According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The ‘InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)’ observational study has been designed to evaluate asthma control and its determinants, including components of asthma management. Methods/design The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs. The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment. The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months. Discussion The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation. Trial registration ClinicalTrials.gov identifier, NCT01567280. PMID:23530817

Publication trends of study protocols in rehabilitation.

PubMed

Jesus, Tiago S; Colquhoun, Heather L

2017-09-04

Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved in rigor and/or transparency if the publications of rehabilitation SRs protocols become more common.

Marked brain asymmetry with intact cognitive functioning in idiopathic Parkinson's disease: a longitudinal analysis.

PubMed

Tanner, Jared J; Levy, Shellie-Anne; Schwab, Nadine A; Hizel, Loren P; Nguyen, Peter T; Okun, Michael S; Price, Catherine C

2017-04-01

A 71-year-old (MN) with an 11-year history of left onset tremor diagnosed as Parkinson's disease (PD) completed longitudinal brain magnetic resonance imaging (MRI) and neuropsychological testing. MRI scans showed an asymmetric caudate nucleus (right < left volume). We describe this asymmetry at baseline and the progression over time relative to other subcortical gray, frontal white matter, and cortical gray matter regions of interest. Isolated structural changes are compared to MN's cognitive profiles. MN completed yearly MRIs and neuropsychological assessments. For comparison, left onset PD (n = 15) and non-PD (n = 43) peers completed the same baseline protocol. All MRI scans were processed with FreeSurfer and the FMRIB Software Library to analyze gray matter structures and frontal fractional anisotropy (FA) metrics. Processing speed, working memory, language, verbal memory, abstract reasoning, visuospatial, and motor functions were examined using reliable change methods. At baseline, MN had striatal volume and frontal lobe thickness asymmetry relative to peers with mild prefrontal white matter FA asymmetry. Over time only MN's right caudate nucleus showed accelerated atrophy. Cognitively, MN had slowed psychomotor speed and visuospatial-linked deficits with mild visuospatial working memory declines longitudinally. This is a unique report using normative neuroimaging and neuropsychology to describe an individual diagnosed with PD who had striking striatal asymmetry followed secondarily by cortical thickness asymmetry and possible frontal white matter asymmetry. His decline and variability in visual working memory could be linked to ongoing atrophy of his right caudate nucleus.

Marked brain asymmetry with intact cognitive functioning in idiopathic Parkinson’s disease: A longitudinal analysis

PubMed Central

Tanner, Jared J.; Levy, Shellie-Anne; Schwab, Nadine A.; Hizel, Loren P.; Nguyen, Peter T.; Okun, Michael S.; Price, Catherine C.

2016-01-01

Objective A 71-year old (MN) with an 11-year history of left onset tremor diagnosed as Parkinson’s disease (PD) completed longitudinal brain magnetic resonance imaging (MRI) and neuropsychological testing. MRI scans showed an asymmetric caudate nucleus (right< left volume). We describe this asymmetry at baseline and the progression over time relative to other subcortical gray, frontal white matter, and cortical gray matter regions of interest. Isolated structural changes are compared to MN’s cognitive profiles. Method MN completed yearly MRIs and neuropsychological assessments. For comparison, left onset PD (n=15) and non-PD (n=43) peers completed the same baseline protocol. All MRI scans were processed with FreeSurfer and the FMRIB Software Library (FSL) to analyze gray matter structures and frontal fractional anisotropy (FA) metrics. Processing speed, working memory, language, verbal memory, abstract reasoning, visuospatial, and motor functions were examined using reliable change methods. Results At baseline MN had striatal volume and frontal lobe thickness asymmetry relative to peers with mild prefrontal white matter FA asymmetry. Over time only MN’s right caudate nucleus showed accelerated atrophy. Cognitively, MN had slowed psychomotor speed and visuospatial-linked deficits with mild visuospatial working memory declines longitudinally. Conclusions This is a unique report using normative neuroimaging and neuropsychology to describe an individual diagnosed with PD who had striking striatal asymmetry followed secondarily by cortical thickness asymmetry and possible frontal white matter asymmetry. His decline and variability in visual working memory could be linked to ongoing atrophy of his right caudate nucleus. PMID:27813459

Digital tooth-based superimposition method for assessment of alveolar bone levels on cone-beam computed tomography images.

PubMed

Romero-Delmastro, Alejandro; Kadioglu, Onur; Currier, G Frans; Cook, Tanner

2014-08-01

Cone-beam computed tomography images have been previously used for evaluation of alveolar bone levels around teeth before, during, and after orthodontic treatment. Protocols described in the literature have been vague, have used unstable landmarks, or have required several software programs, file conversions, or hand tracings, among other factors that could compromise the precision of the measurements. The purposes of this article are to describe a totally digital tooth-based superimposition method for the quantitative assessment of alveolar bone levels and to evaluate its reliability. Ultra cone-beam computed tomography images (0.1-mm reconstruction) from 10 subjects were obtained from the data pool of the University of Oklahoma; 80 premolars were measured twice by the same examiner and a third time by a second examiner to determine alveolar bone heights and thicknesses before and more than 6 months after orthodontic treatment using OsiriX (version 3.5.1; Pixeo, Geneva, Switzerland). Intraexaminer and interexaminer reliabilities were evaluated, and Dahlberg's formula was used to calculate the error of the measurements. Cross-sectional and longitudinal evaluations of alveolar bone levels were possible using a digital tooth-based superimposition method. The mean differences for buccal alveolar crest heights and thicknesses were below 0.10 mm for the same examiner and below 0.17 mm for all examiners. The ranges of errors for any measurement were between 0.02 and 0.23 mm for intraexaminer errors, and between 0.06 and 0.29 mm for interexaminer errors. This protocol can be used for cross-sectional or longitudinal assessment of alveolar bone levels with low interexaminer and intraexaminer errors, and it eliminates the use of less reliable or less stable landmarks and the need for multiple software programs and image printouts. Standardization of the methods for bone assessment in orthodontics is necessary; this method could be the answer to this need. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

A Longitudinal Study of Adolescent Adjustment Following Family Transitions

ERIC Educational Resources Information Center

Ruschena, Eda; Prior, Margot; Sanson, Ann; Smart, Diana

2005-01-01

Background: This study examined the impact of family transitions, that is, parental separation, divorce, remarriage and death, upon the lives of Australian children and adolescents in a longitudinal study of temperament and development. Methods: Using longitudinal and concurrent questionnaire data, outcomes for young people experiencing…

77 FR 51788 - Notice of Submission for OMB Review; Institute of Education Sciences; Education Longitudinal...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

...; Education Longitudinal Study 2002 (ELS:2002) Third Follow-Up Postsecondary Transcripts (ELS:2002 PETS) and Financial Aid Feasibility Study (ELS:2002 FAFS) SUMMARY: The Education Longitudinal Study of 2002 (ELS:2002) is a nationally representative study of two high school grade cohorts (spring 2002 tenth-graders and...

The Impact of Mixing Modes on Reliability in Longitudinal Studies

ERIC Educational Resources Information Center

Cernat, Alexandru

2015-01-01

Mixed-mode designs are increasingly important in surveys, and large longitudinal studies are progressively moving to or considering such a design. In this context, our knowledge regarding the impact of mixing modes on data quality indicators in longitudinal studies is sparse. This study tries to ameliorate this situation by taking advantage of a…

Integrating Prospective Longitudinal Data: Modeling Personality and Health in the Terman Life Cycle and Hawaii Longitudinal Studies

ERIC Educational Resources Information Center

Kern, Margaret L.; Hampson, Sarah E.; Goldberg, Lewis R.; Friedman, Howard S.

2014-01-01

The present study used a collaborative framework to integrate 2 long-term prospective studies: the Terman Life Cycle Study and the Hawaii Personality and Health Longitudinal Study. Within a 5-factor personality-trait framework, teacher assessments of child personality were rationally and empirically aligned to establish similar factor structures…

Restoration of motor function after operative reconstruction of the acutely transected spinal cord in the canine model.

PubMed

Liu, Zehan; Ren, Shuai; Fu, Kuang; Wu, Qiong; Wu, Jun; Hou, Liting; Pan, Hong; Sun, Linlin; Zhang, Jian; Wang, Bingjian; Miao, Qing; Sun, Guiyin; Bonicalzi, Vincenzo; Canavero, Sergio; Ren, Xiaoping

2018-05-01

Cephalosomatic anastomosis or what has been called a "head transplantation" requires full reconnection of the respective transected ends of the spinal cords. The GEMINI spinal cord fusion protocol has been developed for this reason. Here, we report the first randomized, controlled study of the GEMINI protocol in large animals. We conducted a randomized, controlled study of a complete transection of the spinal cord at the level of T10 in dogs at Harbin Medical University, Harbin, China. These dogs were followed for up to 8 weeks postoperatively by assessments of recovery of motor function, somato-sensory evoked potentials, and diffusion tensor imaging using magnetic resonance imaging. A total of 12 dogs were subjected to operative exposure of the dorsal aspect of the spinal cord after laminectomy and longitudinal durotomy followed by a very sharp, controlled, full-thickness, complete transection of the spinal cord at T10. The fusogen, polyethylene glycol, was applied topically to the site of the spinal cord transection in 7 of 12 dogs; 0.9% NaCl saline was applied to the site of transection in the remaining 5 control dogs. Dogs were selected randomly to receive polyethylene glycol or saline. All polyethylene glycol-treated dogs reacquired a substantial amount of motor function versus none in controls over these first 2 months as assessed on the 20-point (0-19), canine, Basso-Beattie-Bresnahan rating scale (P<.006). Somatosensory evoked potentials confirmed restoration of electrical conduction cranially across the site of spinal cord transection which improved over time. Diffusion tensor imaging, a magnetic resonance permutation that assesses the integrity of nerve fibers and cells, showed restitution of the transected spinal cord with polyethylene glycol treatment (at-injury level difference: P<.02). A sharply and fully transected spinal cord at the level of T10 can be reconstructed with restoration of many aspects of electrical continuity in large animals following the GEMINI spinal cord fusion protocol, with objective evidence of motor recovery and of electrical continuity across the site of transection, opening the way to the first cephalosomatic anastomosis. (Surgery 2017;160:XXX-XXX.). Copyright © 2017. Published by Elsevier Inc.

77 FR 2349 - Proposed Information Collection (Vocational Rehabilitation and Employment Longitudinal Study...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-17

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-New (VR&E Longitudinal Study Survey... Rehabilitation and Employment (VR&E) Program. DATES: Written comments and recommendations on the proposed [[Page... . Please refer to ``OMB Control No. 2900--New (VR&E Longitudinal Study Survey)'' in any correspondence...

Beyond Terman: Contemporary Longitudinal Studies of Giftedness and Talent.

ERIC Educational Resources Information Center

Subotnik, Rena F., Ed.; Arnold, Karen D., Ed.

This volume presents 16 papers describing recent longitudinal studies of giftedness. Papers have the following titles and authors: (1) "Longitudinal Study of Giftedness and Talent" (Rena F. Subotnik and Karen D. Arnold); (2) "The Illinois Valedictorian Project: Early Adult Careers of Academically Talented Male High School Students" (Karen D.…

Peer Victimization in Childhood and Internalizing Problems in Adolescence: A Prospective Longitudinal Study

ERIC Educational Resources Information Center

Zwierzynska, Karolina; Wolke, Dieter; Lereya, Tanya S.

2013-01-01

Traumatic childhood experiences have been found to predict later internalizing problems. This prospective longitudinal study investigated whether repeated and intentional harm doing by peers (peer victimization) in childhood predicts internalizing symptoms in early adolescence. 3,692 children from the Avon Longitudinal Study of Parents and…

Studying the Longitudinal Study. I. Introduction: Do Impromptu Essays Show Changes in Critical Thinking over the Span of College? Cautions and Insights from a Pilot Case Study.

ERIC Educational Resources Information Center

Clark, Francelia

The problematic results of longitudinal studies on college writing indicate the need for multidimensional studies to be able to explore perceptible changes in students' writing. Accordingly a small pilot case study, to explore the promise and the limitations of doing a longitudinal multidimensional study, investigated whether impromptu essays…

Exercise and bone mass in adults.

PubMed

Guadalupe-Grau, Amelia; Fuentes, Teresa; Guerra, Borja; Calbet, Jose A L

2009-01-01

There is a substantial body of evidence indicating that exercise prior to the pubertal growth spurt stimulates bone growth and skeletal muscle hypertrophy to a greater degree than observed during growth in non-physically active children. Bone mass can be increased by some exercise programmes in adults and the elderly, and attenuate the losses in bone mass associated with aging. This review provides an overview of cross-sectional and longitudinal studies performed to date involving training and bone measurements. Cross-sectional studies show in general that exercise modalities requiring high forces and/or generating high impacts have the greatest osteogenic potential. Several training methods have been used to improve bone mineral density (BMD) and content in prospective studies. Not all exercise modalities have shown positive effects on bone mass. For example, unloaded exercise such as swimming has no impact on bone mass, while walking or running has limited positive effects. It is not clear which training method is superior for bone stimulation in adults, although scientific evidence points to a combination of high-impact (i.e. jumping) and weight-lifting exercises. Exercise involving high impacts, even a relatively small amount, appears to be the most efficient for enhancing bone mass, except in postmenopausal women. Several types of resistance exercise have been tested also with positive results, especially when the intensity of the exercise is high and the speed of movement elevated. A handful of other studies have reported little or no effect on bone density. However, these results may be partially attributable to the study design, intensity and duration of the exercise protocol, and the bone density measurement techniques used. Studies performed in older adults show only mild increases, maintenance or just attenuation of BMD losses in postmenopausal women, but net changes in BMD relative to control subjects who are losing bone mass are beneficial in decreasing fracture risk. Older men have been less studied than women, and although it seems that men may respond better than their female counterparts, the experimental evidence for a dimorphism based on sex in the osteogenic response to exercise in the elderly is weak. A randomized longitudinal study of the effects of exercise on bone mass in elderly men and women is still lacking. It remains to be determined if elderly females need a different exercise protocol compared with men of similar age. Impact and resistance exercise should be advocated for the prevention of osteoporosis. For those with osteoporosis, weight-bearing exercise in general, and resistance exercise in particular, as tolerated, along with exercise targeted to improve balance, mobility and posture, should be recommended to reduce the likelihood of falling and its associated morbidity and mortality. Additional randomized controlled trials are needed to determine the most efficient training loads depending on age, sex, current bone mass and training history for improvement of bone mass.

Longitudinal Changes in Access to Health Care by Immigrant Status among Older Adults: The Importance of Health Insurance as a Mediator

ERIC Educational Resources Information Center

Choi, Sunha

2011-01-01

Purpose: This longitudinal study examined the role of health insurance in access to health care among older immigrants. Design and Methods: Using data from the Second Longitudinal Study of Aging, the longitudinal trajectories of having a usual source of care were compared between 3 groups (all 70+ years): (a) late-life immigrants with less than 15…

Stress Process of Illicit Drug Use among U.S. Immigrants' Adolescent Children: A Longitudinal Study

ERIC Educational Resources Information Center

Choo, Hyekyung

2012-01-01

This study examined a full path model of stress process for predicting illicit drug use among Asian and Latino immigrants' adolescent children. Using 2-year longitudinal data (National Longitudinal Study of Adolescent Health) from a sample of adolescents with Asian or Latino immigrant parents (N = 2,353), the study explored structural…

Investigation of 2‐stage meta‐analysis methods for joint longitudinal and time‐to‐event data through simulation and real data application

PubMed Central

Tudur Smith, Catrin; Gueyffier, François; Kolamunnage‐Dona, Ruwanthi

2017-01-01

Background Joint modelling of longitudinal and time‐to‐event data is often preferred over separate longitudinal or time‐to‐event analyses as it can account for study dropout, error in longitudinally measured covariates, and correlation between longitudinal and time‐to‐event outcomes. The joint modelling literature focuses mainly on the analysis of single studies with no methods currently available for the meta‐analysis of joint model estimates from multiple studies. Methods We propose a 2‐stage method for meta‐analysis of joint model estimates. These methods are applied to the INDANA dataset to combine joint model estimates of systolic blood pressure with time to death, time to myocardial infarction, and time to stroke. Results are compared to meta‐analyses of separate longitudinal or time‐to‐event models. A simulation study is conducted to contrast separate versus joint analyses over a range of scenarios. Results Using the real dataset, similar results were obtained by using the separate and joint analyses. However, the simulation study indicated a benefit of use of joint rather than separate methods in a meta‐analytic setting where association exists between the longitudinal and time‐to‐event outcomes. Conclusions Where evidence of association between longitudinal and time‐to‐event outcomes exists, results from joint models over standalone analyses should be pooled in 2‐stage meta‐analyses. PMID:29250814

Systematic literature review of determinants of sedentary behaviour in older adults: a DEDIPAC study.

PubMed

Chastin, Sebastien F M; Buck, Christoph; Freiberger, Ellen; Murphy, Marie; Brug, Johannes; Cardon, Greet; O'Donoghue, Grainne; Pigeot, Iris; Oppert, Jean-Michel

2015-10-06

Older adults are the most sedentary segment of society and high sedentary time is associated with poor health and wellbeing outcomes in this population. Identifying determinants of sedentary behaviour is a necessary step to develop interventions to reduce sedentary time. A systematic literature review was conducted to identify factors associated with sedentary behaviour in older adults. Pubmed, Embase, CINAHL, PsycINFO and Web of Science were searched for articles published between 2000 and May 2014. The search strategy was based on four key elements: (a) sedentary behaviour and its synonyms; (b) determinants and its synonyms (e.g. correlates, factors); (c) types of sedentary behaviour (e.g. TV viewing, sitting, gaming) and (d) types of determinants (e.g. environmental, behavioural). Articles were included in the review if specific information about sedentary behaviour in older adults was reported. Studies on samples identified by disease were excluded. Study quality was rated by means of QUALSYST. The full review protocol is available from PROSPERO (PROSPERO 2014: CRD42014009823). The analysis was guided by the socio-ecological model framework. Twenty-two original studies were identified out of 4472 returned by the systematic search. These included 19 cross-sectional, 2 longitudinal and 1 qualitative studies, all published after 2011. Half of the studies were European. The study quality was generally high with a median of 82 % (IQR 69-96 %) using Qualsyst tool. Personal factors were the most frequently investigated with consistent positive association for age, negative for retirement, obesity and health status. Only four studies considered environmental determinants suggesting possible association with mode of transport, type of housing, cultural opportunities and neighbourhood safety and availability of places to rest. Only two studies investigated mediating factors. Very limited information was available on contexts and sub-domains of sedentary behaviours. Few studies have investigated determinants of sedentary behaviour in older adults and these have to date mostly focussed on personal factors, and qualitative studies were mostly lacking. More longitudinal studies are needed as well as inclusion of a broader range of personal and contextual potential determinants towards a systems-based approach, and future studies should be more informed by qualitative work.

Copenhagen comorbidity in HIV infection (COCOMO) study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark.

PubMed

Ronit, Andreas; Haissman, Judith; Kirkegaard-Klitbo, Ditte Marie; Kristensen, Thomas Skårup; Lebech, Anne-Mette; Benfield, Thomas; Gerstoft, Jan; Ullum, Henrik; Køber, Lars; Kjær, Andreas; Kofoed, Klaus; Vestbo, Jørgen; Nordestgaard, Børge; Lundgren, Jens; Nielsen, Susanne Dam

2016-11-26

Modern combination antiretroviral therapy (cART) has improved survival for people living with HIV (PLWHIV). Non-AIDS comorbidities have replaced opportunistic infections as leading causes of mortality and morbidity, and are becoming a key health concern as this population continues to age. The aim of this study is to estimate the prevalence and incidence of non-AIDS comorbidity among PLWHIV in Denmark in the cART era and to determine risk factors contributing to the pathogenesis. The study primarily targets cardiovascular, respiratory, and hepatic non-AIDS comorbidity. The Copenhagen comorbidity in HIV-infection (COCOMO) study is an observational, longitudinal cohort study. The study was initiated in 2015 and recruitment is ongoing with the aim of including 1500 PLWHIV from the Copenhagen area. Follow-up examinations after 2 and 10 years are planned. Uninfected controls are derived from the Copenhagen General Population Study (CGPS), a cohort study including 100,000 uninfected participants from the same geographical region. Physiological and biological measures including blood pressure, ankle-brachial index, electrocardiogram, spirometry, exhaled nitric oxide, transient elastography of the liver, computed tomography (CT) angiography of the heart, unenhanced CT of the chest and upper abdomen, and a number of routine biochemical analysis are uniformly collected in participants from the COCOMO study and the CGPS. Plasma, serum, buffy coat, peripheral blood mononuclear cells (PBMC), urine, and stool samples are collected in a biobank for future studies. Data will be updated through periodical linking to national databases. As life expectancy for PLWHIV improves, it is essential to study long-term impact of HIV and cART. We anticipate that findings from this cohort study will increase knowledge on non-AIDS comorbidity in PLWHIV and identify targets for future interventional trials. Recognizing the demographic, clinical and pathophysiological characteristics of comorbidity in PLWHIV may help inform development of new guidelines and enable us to move forward to a more personalized HIV care. ClinicalTrials.gov: NCT02382822 .

Prefabricated Bar System for Immediate Loading in Edentulous Patients: A 5-Year Follow-Up Prospective Longitudinal Study

PubMed Central

Gherlone, Enrico F.; Rapanelli, Andrea; Crespi, Roberto; Gastaldi, Giorgio

2018-01-01

Objectives The aim of this clinical study was to evaluate a new type of prefabricated bar system, supported by axial and tilted implants at 5-year follow-up. Materials and Methods Twenty-nine consecutive participants (19 females, 10 males) (mean age 61.4 years), edentulous in one or both jaws, with severe atrophy of the posterior regions, were treated according to the All-on-four® protocol with immediately loaded axial (64) and tilted (64) implants supporting complete-arch screw-retained prostheses (12 maxillary, 20 mandibular) featuring a prefabricated bar as framework. Follow-up visits were performed at 3, 6, 12, 24, 48, and 60 months after implant insertion. Radiographic assessments were made using panoramic radiographs obtained immediately after surgery and at each follow-up visit. Bone level measurements around the axial and tilted implants were compared by means of the Student's t-test. Results One axial implant failed in the lower jaw and did not compromise prosthetic function. The 60-month overall implant survival rate was 100% for axially positioned implants and 98.44% for tilted implants. The implant survival rates were 100% in the maxilla and 98.75% in the mandible. None of the 32 fixed prostheses were lost during the observation period, representing a prosthetic survival rate of 100%. No statistically significant differences (P > 0.05) in marginal bone loss between tilted and axial implants were detected in either jaw over time. Conclusions The use of the evaluated prefabricated bar for immediately loaded implants placed according to the All-on-four concept may significantly reduce implant failures; however, more long-term prospective clinical trials are needed to affirm the effectiveness of the surgical-prosthetic protocol. PMID:29682552

Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial.

PubMed

Foraker, Randi E; Pennell, Michael; Sprangers, Peter; Vitolins, Mara Z; DeGraffinreid, Cecilia; Paskett, Electra D

2014-08-01

Low-fat and low-carbohydrate weight-loss diets can have a beneficial effect on longitudinal measures of blood pressure and blood lipids. We aimed to assess longitudinal changes in blood pressure and blood lipids in a population of premenopausal women. We hypothesized that results may differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia. Overweight or obese premenopausal women were randomized to a low-fat (n=41) or low-carbohydrate (n=38) diet. As part of the 52-week Lifestyle Eating and Fitness (LEAF) intervention trial, we fit linear mixed models to determine whether a change in outcome differed by treatment arm. Within-group trends in blood pressure and blood lipids did not differ (p>0.30). Across study arms, there was a significant decrease in systolic blood pressure (SBP, 3 mm Hg, p=0.01) over time, but diastolic blood pressure (DBP) did not change significantly over the course of the study. Blood lipids (total cholesterol [TC], low-density lipoproteins [LDL], and high-density lipoproteins [HDL]) all exhibited nonlinear trends over time (p<0.01); each decreased initially but returned to levels comparable to baseline by study conclusion (p>0.20). We observed a decline in SBP among women who were hypertensive at baseline (p<0.01), but hypercholesterolemia at baseline did not affect trends in blood lipids (p>0.40). Our results support that dietary interventions may be efficacious for lowering blood pressure and blood lipids among overweight or obese premenopausal women. However, a decrease in SBP was the only favorable change that was sustained in this study population. These changes can be maintained over the course of a 1-year intervention, yet changes in blood lipids may be less sustainable.

Individual differences in compliance and agreement for sleep logs and wrist actigraphy: A longitudinal study of naturalistic sleep in healthy adults

PubMed Central

Wasylyshyn, Nick; Roy, Heather; Lieberman, Gregory; Garcia, Javier O.; Asturias, Alex; Okafor, Gold N.; Elliott, James C.; Giesbrecht, Barry; Grafton, Scott T.; Mednick, Sara C.; Vettel, Jean M.

2018-01-01

There is extensive laboratory research studying the effects of acute sleep deprivation on biological and cognitive functions, yet much less is known about naturalistic patterns of sleep loss and the potential impact on daily or weekly functioning of an individual. Longitudinal studies are needed to advance our understanding of relationships between naturalistic sleep and fluctuations in human health and performance, but it is first necessary to understand the efficacy of current tools for long-term sleep monitoring. The present study used wrist actigraphy and sleep log diaries to obtain daily measurements of sleep from 30 healthy adults for up to 16 consecutive weeks. We used non-parametric Bland-Altman analysis and correlation coefficients to calculate agreement between subjectively and objectively measured variables including sleep onset time, sleep offset time, sleep onset latency, number of awakenings, the amount of wake time after sleep onset, and total sleep time. We also examined compliance data on the submission of daily sleep logs according to the experimental protocol. Overall, we found strong agreement for sleep onset and sleep offset times, but relatively poor agreement for variables related to wakefulness including sleep onset latency, awakenings, and wake after sleep onset. Compliance tended to decrease significantly over time according to a linear function, but there were substantial individual differences in overall compliance rates. There were also individual differences in agreement that could be explained, in part, by differences in compliance. Individuals who were consistently more compliant over time also tended to show the best agreement and lower scores on behavioral avoidance scale (BIS). Our results provide evidence for convergent validity in measuring sleep onset and sleep offset with wrist actigraphy and sleep logs, and we conclude by proposing an analysis method to mitigate the impact of non-compliance and measurement errors when the two methods provide discrepant estimates. PMID:29377925

Improvement in lipids after switch to boosted atazanavir or darunavir in children/adolescents with perinatally acquired HIV on older protease inhibitors: results from the Pediatric HIV/AIDS Cohort Study.

PubMed

Jao, J; Yu, W; Patel, K; Miller, T L; Karalius, B; Geffner, M E; DiMeglio, L A; Mirza, A; Chen, J S; Silio, M; McFarland, E J; Van Dyke, R B; Jacobson, D

2018-03-01

Dyslipidaemia is common in perinatally HIV-infected (PHIV) youth receiving protease inhibitors (PIs). Few studies have evaluated longitudinal lipid changes in PHIV youth after switch to newer PIs. We compared longitudinal changes in fasting lipids [total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and TC:HDL-C ratio] in PHIV youth enrolled in the Pediatric HIV/AIDS Cohort Study (PHACS) Adolescent Master Protocol (AMP) study who switched to atazanavir/ritonavir (ATV/r)- or darunavir/ritonavir (DRV/r)-based antiretroviral therapy (ART) from an older PI-based ART and those remaining on an older PI. Generalized estimating equation models were fitted to assess the association of a switch to ATV/r- or DRV/r-based ART with the rate of change in lipids, adjusted for potential confounders. From 2007 to 2014, 47 PHIV children/adolescents switched to ATV/r or DRV/r, while 120 remained on an older PI [primarily lopinavir/r (72%) and nelfinavir (24%)]. Baseline age ranged from 7 to 21 years. After adjustment for age, Tanner stage, race/ethnicity, and HIV RNA level, a switch to ATV/r or DRV/r was associated with a more rapid annual rate of decline in the ratio of TC:HDL-C. (β = -0.12; P = 0.039) than remaining on an older PI. On average, TC declined by 4.57 mg/dL/year (P = 0.057) more in the switch group. A switch to ATV/r or DRV/r was not associated with the rate of HDL-C, LDL-C, or TG change. A switch to ATV/r or DRV/r may result in more rapid reduction in TC and the TC:HDL-C ratio in PHIV youth, potentially impacting long-term cardiovascular disease risk. © 2017 British HIV Association.

Effect of a Low-Fat or Low-Carbohydrate Weight-Loss Diet on Markers of Cardiovascular Risk Among Premenopausal Women: A Randomized Trial

PubMed Central

Pennell, Michael; Sprangers, Peter; Vitolins, Mara Z.; DeGraffinreid, Cecilia; Paskett, Electra D.

2014-01-01

Abstract Background: Low-fat and low-carbohydrate weight-loss diets can have a beneficial effect on longitudinal measures of blood pressure and blood lipids. We aimed to assess longitudinal changes in blood pressure and blood lipids in a population of premenopausal women. We hypothesized that results may differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia. Methods: Overweight or obese premenopausal women were randomized to a low-fat (n=41) or low-carbohydrate (n=38) diet. As part of the 52-week Lifestyle Eating and Fitness (LEAF) intervention trial, we fit linear mixed models to determine whether a change in outcome differed by treatment arm. Results: Within-group trends in blood pressure and blood lipids did not differ (p>0.30). Across study arms, there was a significant decrease in systolic blood pressure (SBP, 3 mm Hg, p=0.01) over time, but diastolic blood pressure (DBP) did not change significantly over the course of the study. Blood lipids (total cholesterol [TC], low-density lipoproteins [LDL], and high-density lipoproteins [HDL]) all exhibited nonlinear trends over time (p<0.01); each decreased initially but returned to levels comparable to baseline by study conclusion (p>0.20). We observed a decline in SBP among women who were hypertensive at baseline (p<0.01), but hypercholesterolemia at baseline did not affect trends in blood lipids (p>0.40). Conclusions: Our results support that dietary interventions may be efficacious for lowering blood pressure and blood lipids among overweight or obese premenopausal women. However, a decrease in SBP was the only favorable change that was sustained in this study population. These changes can be maintained over the course of a 1-year intervention, yet changes in blood lipids may be less sustainable. PMID:25029619

Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya

PubMed Central

Brooker, Simon J; Mwandawiro, Charles S; Halliday, Katherine E; Njenga, Sammy M; Mcharo, Carlos; Gichuki, Paul M; Wasunna, Beatrice; Kihara, Jimmy H; Njomo, Doris; Alusala, Dorcas; Chiguzo, Athuman; Turner, Hugo C; Teti, Caroline; Gwayi-Chore, Claire; Nikolay, Birgit; Truscott, James E; Hollingsworth, T Déirdre; Balabanova, Dina; Griffiths, Ulla K; Freeman, Matthew C; Allen, Elizabeth; Pullan, Rachel L; Anderson, Roy M

2015-01-01

Introduction In recent years, an unprecedented emphasis has been given to the control of neglected tropical diseases, including soil-transmitted helminths (STHs). The mainstay of STH control is school-based deworming (SBD), but mathematical modelling has shown that in all but very low transmission settings, SBD is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH, and, if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? Methods and analysis Two cluster randomised trials are being implemented in contrasting settings in Kenya. The interventions are annual mass anthelmintic treatment delivered to preschool- and school-aged children, as part of a national SBD programme, or to entire communities, delivered by community health workers. Allocation to study group is by cluster, using predefined units used in public health provision—termed community units (CUs). CUs are randomised to one of three groups: receiving either (1) annual SBD; (2) annual community-based deworming (CBD); or (3) biannual CBD. The primary outcome measure is the prevalence of hookworm infection, assessed by four cross-sectional surveys. Secondary outcomes are prevalence of Ascaris lumbricoides and Trichuris trichiura, intensity of species infections and treatment coverage. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, worm burden and proportion of unfertilised eggs will be assessed longitudinally. A nested process evaluation, using semistructured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. Ethics and dissemination Study protocols have been reviewed and approved by the ethics committees of the Kenya Medical Research Institute and National Ethics Review Committee, and London School of Hygiene and Tropical Medicine. The study has a dedicated web site. Trial registration number NCT02397772. PMID:26482774

A hospital-based observational cohort study exploring pain and biomarkers in patients with hand osteoarthritis in Norway: The Nor-Hand protocol

PubMed Central

Gløersen, Marthe; Mulrooney, Elisabeth; Hammer, Hilde Berner; Slatkowsky-Christensen, Barbara; Faraj, Karwan; Isaksen, Thore; Neogi, Tuhina; Kvien, Tore K; Magnusson, Karin; Haugen, Ida Kristin

2017-01-01

Introduction We have limited knowledge about the underlying disease mechanisms and causes of pain in hand osteoarthritis (OA). Consequently, no disease-modifying drug exists, and more knowledge about the pathogenesis of hand OA is needed, as well as a validation of different outcome measures. Our first aim of this study is to explore the validity of various imaging modalities for the assessment of hand OA. Second, we want to gain a better understanding of the disease processes, with a special focus on pain mechanisms. Methods and analysis The Nor-Hand study is a hospital-based observational study including 300 patients with evidence of hand OA by ultrasound and/or clinical examination. The baseline examination consists of functional tests and joint assessment of the hands, medical assessment, pain sensitisation tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet), CT and MRI of the dominant hand, conventional radiographs of the hands and feet, fluorescence optical imaging of the hands, collection of blood and urine samples as well as self-reported demographic factors and OA-related questionnaires. Two follow-up examinations are planned. Cross-sectional analyses will be used to investigate agreements and associations between different relevant measures at the baseline examination, whereas the longitudinal data will be used for evaluation of predictors for clinical outcomes. Ethics and dissemination The protocol is approved by the Norwegian Regional Committee for Medical and Health Research Ethics (Ref. no: 2014/2057). The participants receive oral and written information about the project and sign a consent form before participation. They can, whenever they want, withdraw from the study, and all de-identified data will be safely stored on the research server at Diakonhjemmet Hospital. Results will be presented at international and national congresses and in peer-reviewed rheumatology journals. Trial registration number NCT03083548; Pre-results. PMID:28947452

A hospital-based observational cohort study exploring pain and biomarkers in patients with hand osteoarthritis in Norway: The Nor-Hand protocol.

PubMed

Gløersen, Marthe; Mulrooney, Elisabeth; Mathiessen, Alexander; Hammer, Hilde Berner; Slatkowsky-Christensen, Barbara; Faraj, Karwan; Isaksen, Thore; Neogi, Tuhina; Kvien, Tore K; Magnusson, Karin; Haugen, Ida Kristin

2017-09-24

We have limited knowledge about the underlying disease mechanisms and causes of pain in hand osteoarthritis (OA). Consequently, no disease-modifying drug exists, and more knowledge about the pathogenesis of hand OA is needed, as well as a validation of different outcome measures. Our first aim of this study is to explore the validity of various imaging modalities for the assessment of hand OA. Second, we want to gain a better understanding of the disease processes, with a special focus on pain mechanisms. The Nor-Hand study is a hospital-based observational study including 300 patients with evidence of hand OA by ultrasound and/or clinical examination. The baseline examination consists of functional tests and joint assessment of the hands, medical assessment, pain sensitisation tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet), CT and MRI of the dominant hand, conventional radiographs of the hands and feet, fluorescence optical imaging of the hands, collection of blood and urine samples as well as self-reported demographic factors and OA-related questionnaires. Two follow-up examinations are planned. Cross-sectional analyses will be used to investigate agreements and associations between different relevant measures at the baseline examination, whereas the longitudinal data will be used for evaluation of predictors for clinical outcomes. The protocol is approved by the Norwegian Regional Committee for Medical and Health Research Ethics (Ref. no: 2014/2057). The participants receive oral and written information about the project and sign a consent form before participation. They can, whenever they want, withdraw from the study, and all de-identified data will be safely stored on the research server at Diakonhjemmet Hospital. Results will be presented at international and national congresses and in peer-reviewed rheumatology journals. NCT03083548; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Protocol of a feasibility study for cognitive assessment of an ageing cohort within the Southeast Asia Community Observatory (SEACO), Malaysia

PubMed Central

Mohan, Devi; Stephan, Blossom C M; Allotey, Pascale; Jagger, Carol; Pearce, Mark; Siervo, Mario; Reidpath, Daniel D

2017-01-01

Introduction There is a growing proportion of population aged 65 years and older in low-income and middle-income countries. In Malaysia, this proportion is predicted to increase from 5.1% in 2010 to more than 15.4% by 2050. Cognitive ageing and dementia are global health priorities. However, risk factors and disease associations in a multiethnic, middle-income country like Malaysia may not be consistent with those reported in other world regions. Knowing the burden of cognitive impairment and its risk factors in Malaysia is necessary for the development of management strategies and would provide valuable information for other transitional economies. Methods and analysis This is a community-based feasibility study focused on the assessment of cognition, embedded in the longitudinal study of health and demographic surveillance site of the South East Asia Community Observatory (SEACO), in Malaysia. In total, 200 adults aged ≥50 years are selected for an in-depth health and cognitive assessment including the Mini Mental State Examination, the Montreal Cognitive Assessment, blood pressure, anthropometry, gait speed, hand grip strength, Depression Anxiety Stress Score and dried blood spots. Discussion and conclusions The results will inform the feasibility, response rates and operational challenges for establishing an ageing study focused on cognitive function in similar middle-income country settings. Knowing the burden of cognitive impairment and dementia and risk factors for disease will inform local health priorities and management, and place these within the context of increasing life expectancy. Ethics and dissemination The study protocol is approved by the Monash University Human Research Ethics Committee. Informed consent is obtained from all the participants. The project's analysed data and findings will be made available through publications and conference presentations and a data sharing archive. Reports on key findings will be made available as community briefs on the SEACO website. PMID:28104710

Toward the greening of nuclear energy: A content analysis of nuclear energy frames from 1991 to 2008

NASA Astrophysics Data System (ADS)

Miller, Sonya R.

Framing theory has emerged as one of the predominant theories employed in mass communications research in the 21st century. Frames are identified as interpretive packages for content where some issue attributes are highlighted over other attributes. While framing effects studies appear plentiful, longitudinal studies assessing trends in dominant framing packages and story elements for an issue appear to be less understood. Through content analysis, this study examines dominant frame packages, story elements, headline tone, story tone, stereotypes, and source attribution for nuclear energy from 1991-2008 in the New York Times, USA Today, the Wall Street Journal, and the Washington Post. Unlike many content analysis studies, this study compares intercoder reliability among three indices---percentage agreement, proportional reduction of loss and Scott's Pi. The newspapers represented in this study possess a commonality in the types of dominant frames packages employed. Significant dominant frame packages among the four newspapers include human/health, proliferation, procedural, and marketplace. While the procedural frame package was more likely to appear prior to the 1997 Kyoto Protocol, the proliferation frame packaged was more likely to appear after the Kyoto Protol. Over time, the sustainable frame package demonstrated increased significance. This study is part of the growing literature regarding the function of frames over time.

77 FR 20885 - Agency Information Collection (Vocational Rehabilitation and Employment Longitudinal Study Survey...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-New (VR&E Longitudinal Study Survey)] Agency... Building, Room 10235, Washington, DC 20503 (202) 395-7316. Please refer to ``OMB Control No. 2900-New (VR&E....gov . Please refer to ``OMB Control No. 2900-New (VR&E Longitudinal Study Survey)''. SUPPLEMENTARY...

The Timing of Maternal Depressive Symptoms and Child Cognitive Development: A Longitudinal Study

ERIC Educational Resources Information Center

Evans, Jonathan; Melotti, Roberto; Heron, Jon; Ramchandani, Paul; Wiles, Nicola; Murray, Lynne; Stein, Alan

2012-01-01

Background: Maternal depression is known to be associated with impairments in child cognitive development, although the effect of timing of exposure to maternal depression is unclear. Methods: Data collected for the Avon Longitudinal Study of Parents and Children, a longitudinal study beginning in pregnancy, included self-report measures of…

National Prevalence Rates of Bully Victimization among Students with Disabilities in the United States

ERIC Educational Resources Information Center

Blake, Jamilia J.; Lund, Emily M.; Zhou, Qiong; Kwok, Oi-man; Benz, Michael R.

2012-01-01

This study examined the prevalence rates of bully victimization and risk for repeated victimization among students with disabilities using the Special Education Elementary Longitudinal Study and the National Longitudinal Transition Study-2 longitudinal datasets. Results revealed that a prevalence rate ranging from 24.5% in elementary school to…

Fears in Czech Adolescents: A Longitudinal Study

ERIC Educational Resources Information Center

Michalcáková, Radka; Lacinová, Lenka; Kyjonková, Hana; Bouša, Ondrej; Jelínek, Martin

2013-01-01

The present study investigates developmental patterns of fear in adolescence. It is based on longitudinal data collected as a part of the European Longitudinal Study of Pregnancy and Childhood (ELSPAC) project. A total of 186 Czech adolescents (43% girls) were assessed repeatedly at the age of 11, 13, and 15 years. The free-response method was…

Reducing Bias Due to Systematic Attrition in Longitudinal Studies: The Benefits of Multiple Imputation

ERIC Educational Resources Information Center

Asendorpf, Jens B.; van de Schoot, Rens; Denissen, Jaap J. A.; Hutteman, Roos

2014-01-01

Most longitudinal studies are plagued by drop-out related to variables at earlier assessments (systematic attrition). Although systematic attrition is often analysed in longitudinal studies, surprisingly few researchers attempt to reduce biases due to systematic attrition, even though this is possible and nowadays technically easy. This is…

Nonlinear Gompertz Curve Models of Achievement Gaps in Mathematics and Reading

ERIC Educational Resources Information Center

Cameron, Claire E.; Grimm, Kevin J.; Steele, Joel S.; Castro-Schilo, Laura; Grissmer, David W.

2015-01-01

This study examined achievement trajectories in mathematics and reading from school entry through the end of middle school with linear and nonlinear growth curves in 2 large longitudinal data sets (National Longitudinal Study of Youth--Children and Young Adults and Early Childhood Longitudinal Study--Kindergarten Cohort [ECLS-K]). The S-shaped…

Paternal Alcoholism, Family Functioning, and Infant Mental Health

ERIC Educational Resources Information Center

Fitzgerald, Hiram E.; Eiden, Rina Das

2007-01-01

The authors share results from two longitudinal studies exploring the impact of father's alcohol use on child development. The Michigan Longitudinal Study (MLS) has followed a sample of alcoholic families with 3-5 year old children for 20 years. The Buffalo Longitudinal Study (BLS) has followed a sample of alcoholic and nonalcoholic families…

Imaging of cartilage and bone: promises and pitfalls in clinical trials of osteoarthritis

PubMed Central

Eckstein, F.; Guermazi, A.; Gold, G.; Duryea, J.; Le Graverand, M.-P. Hellio; Wirth, W.; Miller, C.G.

2015-01-01

summary Imaging in clinical trials is used to evaluate subject eligibility, and/or efficacy of intervention, supporting decision making in drug development by ascertaining treatment effects on joint structure. This review focusses on imaging of bone and cartilage in clinical trials of (knee) osteoarthritis. We narratively review the full-text literature on imaging of bone and cartilage, adding primary experience in the implementation of imaging methods in clinical trials. Aims and constraints of applying imaging in clinical trials are outlined. The specific uses of semi-quantitative and quantitative imaging biomarkers of bone and cartilage in osteoarthritis trials are summarized, focusing on radiography and magnetic resonance imaging (MRI). Studies having compared both imaging methodologies directly and those having established a relationship between imaging biomarkers and clinical outcomes are highlighted. To make this review of practical use, recommendations are provided as to which imaging protocols are ideal for capturing specific aspects of bone and cartilage tissue, and pitfalls in their usage are highlighted. Further, the longitudinal sensitivity to change, of different imaging methods is reported for various patient strata. From these power calculations can be accomplished, provided the strength of the treatment effect is known. In conclusion, current imaging methodologies provide powerful tools for scoring and measuring morphological and compositional aspects of most articular tissues, capturing longitudinal change with reasonable to excellent sensitivity. When employed properly, imaging has tremendous potential for ascertaining treatment effects on various joint structures, potentially over shorter time scales than required for demonstrating effects on clinical outcomes. PMID:25278061

Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast Cancer

PubMed Central

Wyatt, Gwen; Sikorskii, Alla; Rahbar, Mohammad Hossein; Victorson, David; You, Mei

2013-01-01

Purpose/Objectives To evaluate the safety and efficacy of reflexology, a complementary therapy that applies pressure to specific areas of the feet. Design Longitudinal, randomized clinical trial. Setting Thirteen community-based medical oncology clinics across the midwestern United States. Sample A convenience sample of 385 predominantly Caucasian women with advanced-stage breast cancer receiving chemotherapy and/or hormonal therapy. Methods Following the baseline interview, women were randomized into three primary groups: reflexology (n = 95), lay foot manipulation (LFM) (n = 95), or conventional care (n = 96). Two preliminary reflexology (n = 51) and LFM (n = 48) test groups were used to establish the protocols. Participants were interviewed again postintervention at study weeks 5 and 11. Main Research Variables Breast cancer–specific health-related quality of life (HRQOL), physical functioning, and symptoms. Findings No adverse events were reported. A longitudinal comparison revealed significant improvements in physical functioning for the reflexology group compared to the control group (p = 0.04). Severity of dyspnea was reduced in the reflexology group compared to the control group (p < 0.01) and the LFM group (p = 0.02). No differences were found on breast cancer–specific HRQOL, depressive symptomatology, state anxiety, pain, and nausea. Conclusions Reflexology may be added to existing evidence-based supportive care to improve HRQOL for patients with advanced-stage breast cancer during chemotherapy and/or hormonal therapy. Implications for Nursing Reflexology can be recommended for safety and usefulness in relieving dyspnea and enhancing functional status among women with advanced-stage breast cancer. PMID:23107851

Out with the old, in with the new: Assessing change in screen time when measurement changes over time.

PubMed

Gunnell, Katie E; Brunet, Jennifer; Bélanger, Mathieu

2018-03-01

We examined if screen time can be assessed over time when the measurement protocol has changed to reflect advances in technology. Beginning in 2011, 929 youth (9-12 years at time one) living in in New Brunswick (Canada) self-reported the amount of time spent watching television (cycles 1-13), using computers (cycles 1-13), and playing video games (cycles 3-13). Using longitudinal invariance to test a shifting indicators model of screen time, we found that the relationships between the latent variable reflecting overall screen time and the indicators used to assess screen time were invariant across cycles (weak invariance). We also found that 31 out of 37 indicator intercepts were invariant, meaning that most indicators were answered similarly (i.e., on the same metric) across cycles (partial strong invariance), and that 28 out of 37 indicator residuals were invariant indicating that similar sources of error were present over time (partial strict invariance). Overall, across all survey cycles, 76% of indicators were fully invariant. Whereas issues were noted when new examples of screen-based technology (e.g., iPads) were added, having established partial invariance, we suggest it is still possible to assess change in screen time despite having changing indicators over time. Although it is not possible to draw definitive conclusions concerning other self-report measures of screen time, our findings may assist other researchers considering modifying self-report measures in longitudinal studies to reflect technological advancements and increase the precision of their results.

Camden active spaces: Does the construction of active school playgrounds influence children's physical activity levels? A longitudinal quasi-experiment protocol

PubMed Central

Smith, Lee; Kipps, Courtney; Aggio, Daniel; Fox, Paul; Robinson, Nigel; Trend, Verena; Munnery, Suzie; Kelly, Barry; Hamer, Mark

2014-01-01

Introduction Physical activity is essential for every facet of children's health. However, physical activity levels in British children are low. The school environment is a promising setting to increase children's physical activity but limited empirical evidence exists on how a change in the outdoor physical school environment influences physical activity behaviour. The London Borough of Camden is redesigning seven existing school playgrounds to engage children to become more physically active. The primary aim of this project is to evaluate the impact of the redesigned playgrounds on children's physical activity, well-being and physical function/fitness. Method and analysis This project will use a longitudinal quasi-experimental design. Seven experimental schools and one control school will take part. One baseline data collection session and two follow-ups will be carried out. Between baseline and follow-up, the experimental school playgrounds will be redesigned. At baseline, a series of fitness tests, anthropometric and questionnaire measurements, and 7-day objective physical activity monitoring (Actigraph accelerometer) will be carried out on children (aged 5–16 years). This will be repeated at follow-up. Changes in overall physical activity levels and levels during different times of the day (eg, school breaks) will be examined. Multilevel regression modelling will be used to analyse the data. Ethics and dissemination The results of this study will be disseminated through peer-review publications and scientific presentations. Ethical approval was obtained through the University College London Research Ethics Committee (Reference number: 4400/002). PMID:25232566

Accelerometry: A feasible method to monitor physical activity during sub-acute rehabilitation of persons with stroke.

PubMed

Joseph, Conran; Strömbäck, Björn; Hagströmer, Maria; Conradsson, David

2018-05-08

To investigate the feasibility of using accelerometers to monitor physical activity in persons with stroke admitted to inpatient rehabilitation. Longitudinal observational study. Persons with stroke admitted to a specialized rehabilitation centre for sub-acute rehabilitation were recruited between August and December 2016. Volume and intensity of physical activity were assessed with accelerometers throughout the rehabilitation period. Indicators of feasibility included processes (recruitment, protocol adherence and participants' experiences) and scientific feasibility, which assessed the accelerometers' ability to detect change in physical activity among stroke survivors who ambulate independently and those who are dependent on a mobility device. Twenty-seven out of 31 eligible individuals took part in this study, with 23 (85%) completing it. In total, 432 days of rehabilitation were monitored and valid physical activity data were obtained for 408 days (94%). There were no indications that the measurement interfered with participants' ability to participate in rehabilitation. Despite the subjects' ambulation status, the number of steps and time spent in moderate-to-vigorous physical activity increased significantly across the first 18 days of rehabilitation, whereas sedentary time was unchanged. This study supports the feasibility of using accelerometers to capture physical activity behaviour in survivors of stroke during inpatient rehabilitation.

Ultrasonic characterization of silicate glasses, polymer composites and hydrogels

NASA Astrophysics Data System (ADS)

Lee, Wan Jae

In many applications of material designing and engineering, high-frequency linear viscoelastic properties of materials are essential. Traditionally, the high-frequency properties are estimated through the time-temperature superposition (WLF equation) of low-frequency data, which are questionable because the existence of multi-phase in elastomer compounds. Moreover, no reliable data at high frequencies over MHz have been available thus far. Ultrasound testing is cost-effective for measuring high-frequency properties. Although both ultrasonic longitudinal and shear properties are necessary in order to fully characterize high-frequency mechanical properties of materials, longitudinal properties will be extensively explored in this thesis. Ultrasonic pulse echo method measures longitudinal properties. A precision ultrasonic measurement system has been developed in our laboratory, which allows us to monitor the in-situ bulk and/or surface properties of silicate glasses, polymer composites and even hydrogels. The system consists of a pulse-echo unit and an impedance measurement unit. A pulse echo unit is explored mainly. First, a systematic procedure was developed to obtain precise water wavespeed value. A calibration curve of water wavespeed as a function of temperature has been established, and water wavespeed at 23°C serves as a yardstick to tell whether or not a setup is properly aligned. Second, a sound protocol in calculating attenuation coefficient and beam divergence effects was explored using three kinds of silicate glass of different thicknesses. Then the system was applied to four composite slabs, two slabs for each type of fiberglass reinforced plastics, phenolic and polyester manufactured under different processing conditions: one was made by the normal procedures and the other with deliberate flaws such as voids, tapes and/or prepared at improper operation temperature and pressure. The experiment was conducted under the double blind test protocol. After carefully and methodically analyzing the data, we are able to detect defected specimens from all the specimens supplied to us, differentiate polyester-based composite from the phenolic-based composite and even recognized types of defects. Lastly, ultrasonic monitoring of advancement of the swollen-unswollen fronts, and hence monitor phase transition from glassy state to rubbery state, of poly(acrylic-acid) hydrogel of one of the three different crosslinking densities is performed. With ultrasonic measurement, swelling monitoring is possible since the structural and mechanical changes during swelling of a dry hydrogel are related to changes in density and elastic constants. Using our carefully developed methodology from previous chapters, we may obtain and monitor average acoustic properties of each layer of hydrogel as it swells.

Longitudinal multigroup invariance analysis of the satisfaction with food-related life scale in university students.

PubMed

Schnettler, Berta; Miranda, Horacio; Miranda-Zapata, Edgardo; Salinas-Oñate, Natalia; Grunert, Klaus G; Lobos, Germán; Sepúlveda, José; Orellana, Ligia; Hueche, Clementina; Bonilla, Héctor

2017-06-01

This study examined longitudinal measurement invariance in the Satisfaction with Food-related Life (SWFL) scale using follow-up data from university students. We examined this measure of the SWFL in different groups of students, separated by various characteristics. Through non-probabilistic longitudinal sampling, 114 university students (65.8% female, mean age: 22.5) completed the SWFL questionnaire three times, over intervals of approximately one year. Confirmatory factor analysis was used to examine longitudinal measurement invariance. Two types of analysis were conducted: first, a longitudinal invariance by time, and second, a multigroup longitudinal invariance by sex, age, socio-economic status and place of residence during the study period. Results showed that the 3-item version of the SWFL exhibited strong longitudinal invariance (equal factor loadings and equal indicator intercepts). Longitudinal multigroup invariance analysis also showed that the 3-item version of the SWFL displays strong invariance by socio-economic status and place of residence during the study period over time. Nevertheless, it was only possible to demonstrate equivalence of the longitudinal factor structure among students of both sexes, and among those older and younger than 22 years. Generally, these findings suggest that the SWFL scale has satisfactory psychometric properties for longitudinal measurement invariance in university students with similar characteristics as the students that participated in this research. It is also possible to suggest that satisfaction with food-related life is associated with sex and age. Copyright © 2017 Elsevier Ltd. All rights reserved.

Stability and change in adult personality over 6 years: findings from the Victoria Longitudinal Study.

PubMed

Small, Brent J; Hertzog, Christopher; Hultsch, David F; Dixon, Roger A

2003-05-01

Data from the Victoria Longitudinal Study were used to examine the 6-year longitudinal stability of personality in older adults. Personality was measured with the NEO Personality Inventory. The longitudinal sample consisted of 223 adults initially ranging from 55 to 85 years of age. Longitudinal confirmatory factor analyses were used to examine the stability of individual differences in change over time, and the stability of the longitudinal factor structure. The results indicated both substantial stability at the level of individual differences in change, as well as significant individual differences in change that were related to age and gender. Finally, the factor structure of personality was invariant over time but did not approximate simple structure for the five dimensions of personality. Our study of 6-year personality development provided both (a). a confirmation of early significant stability findings and (b). unique evidence for significant individual differences in late adulthood.

Why Missing Data Matter in the Longitudinal Study of Adolescent Development: Using the 4-H Study to Understand the Uses of Different Missing Data Methods

ERIC Educational Resources Information Center

Jelicic, Helena; Phelps, Erin; Lerner, Richard M.

2010-01-01

The study of adolescent development rests on methodologically appropriate collection and interpretation of longitudinal data. While all longitudinal studies of adolescent development involve missing data, the methods to treat missingness that have been recommended most often focus on missing data from cross-sectional studies. The problems of…

Analyzing the effect of routing protocols on media access control protocols in radio networks

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

Barrett, C. L.; Drozda, M.; Marathe, A.

2002-01-01

We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i)more » number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.« less

Optimal early active mobilisation protocol after extensor tendon repairs in zones V and VI: A systematic review of literature.

PubMed

Collocott, Shirley Jf; Kelly, Edel; Ellis, Richard F

2018-03-01

Early mobilisation protocols after repair of extensor tendons in zone V and VI provide better outcomes than immobilisation protocols. This systematic review investigated different early active mobilisation protocols used after extensor tendon repair in zone V and VI. The purpose was to determine whether any one early active mobilisation protocol provides superior results. An extensive literature search was conducted to identify articles investigating the outcomes of early active mobilisation protocols after extensor tendon repair in zone V and VI. Databases searched were AMED, Embase, Medline, Cochrane and CINAHL. Studies were included if they involved participants with extensor tendon repairs in zone V and VI in digits 2-5 and described a post-operative rehabilitation protocol which allowed early active metacarpophalangeal joint extension. Study designs included were randomised controlled trials, observational studies, cohort studies and case series. The Structured Effectiveness Quality Evaluation Scale was used to evaluate the methodological quality of the included studies. Twelve articles met the inclusion criteria. Two types of early active mobilisation protocols were identified: controlled active motion protocols and relative motion extension splinting protocols. Articles describing relative motion extension splinting protocols were more recent but of lower methodological quality than those describing controlled active motion protocols. Participants treated with controlled active motion and relative motion extension splinting protocols had similar range of motion outcomes, but those in relative motion extension splinting groups returned to work earlier. The evidence reviewed suggested that relative motion extension splinting protocols may allow an earlier return to function than controlled active motion protocols without a greater risk of complication.

Impact of PET/CT system, reconstruction protocol, data analysis method, and repositioning on PET/CT precision: An experimental evaluation using an oncology and brain phantom.

PubMed

Mansor, Syahir; Pfaehler, Elisabeth; Heijtel, Dennis; Lodge, Martin A; Boellaard, Ronald; Yaqub, Maqsood

2017-12-01

In longitudinal oncological and brain PET/CT studies, it is important to understand the repeatability of quantitative PET metrics in order to assess change in tracer uptake. The present studies were performed in order to assess precision as function of PET/CT system, reconstruction protocol, analysis method, scan duration (or image noise), and repositioning in the field of view. Multiple (repeated) scans have been performed using a NEMA image quality (IQ) phantom and a 3D Hoffman brain phantom filled with 18 F solutions on two systems. Studies were performed with and without randomly (< 2 cm) repositioning the phantom and all scans (12 replicates for IQ phantom and 10 replicates for Hoffman brain phantom) were performed at equal count statistics. For the NEMA IQ phantom, we studied the recovery coefficients (RC) of the maximum (SUV max ), peak (SUV peak ), and mean (SUV mean ) uptake in each sphere as a function of experimental conditions (noise level, reconstruction settings, and phantom repositioning). For the 3D Hoffman phantom, the mean activity concentration was determined within several volumes of interest and activity recovery and its precision was studied as function of experimental conditions. The impact of phantom repositioning on RC precision was mainly seen on the Philips Ingenuity PET/CT, especially in the case of smaller spheres (< 17 mm diameter, P < 0.05). This effect was much smaller for the Siemens Biograph system. When exploring SUV max , SUV peak , or SUV mean of the spheres in the NEMA IQ phantom, it was observed that precision depended on phantom repositioning, reconstruction algorithm, and scan duration, with SUV max being most and SUV peak least sensitive to phantom repositioning. For the brain phantom, regional averaged SUVs were only minimally affected by phantom repositioning (< 2 cm). The precision of quantitative PET metrics depends on the combination of reconstruction protocol, data analysis methods and scan duration (scan statistics). Moreover, precision was also affected by phantom repositioning but its impact depended on the data analysis method in combination with the reconstructed voxel size (tissue fraction effect). This study suggests that for oncological PET studies the use of SUV peak may be preferred over SUV max because SUV peak is less sensitive to patient repositioning/tumor sampling. © 2017 The Authors. Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Reading Fluency from Grade 2-6: A Longitudinal Examination

ERIC Educational Resources Information Center

Lipka, Orly

2017-01-01

The goal of this study was to examine oral word reading fluency from a developmental perspective in a longitudinal study of students from second grade to sixth grade. The sample consisted of native English speaking students that took part in a large longitudinal study. Participants were assessed on cognitive and literacy measures such as working…

Early Predictors of Adolescent Depression: A 7-Year Longitudinal Study

ERIC Educational Resources Information Center

Mazza, James J.; Abbott, Robert D.; Fleming, Charles B.; Harachi, Tracy W.; Cortes, Rebecca C.; Park, Jisuk; Haggerty, Kevin P.; Catalano, Richard F.

2009-01-01

This study examined the longitudinal relationship of early elementary predictors to adolescent depression 7 years later. The sample consisted of 938 students who have been part of a larger longitudinal study that started in 1993. Data collected from parents, teachers, and youth self-reports on early risk factors when students were in 1st and 2nd…

77 FR 22068 - Proposed Information Collection (Post-9/11 GI Bill Education Longitudinal Study Survey) Activity...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-New (Post-9/11 GI Bill Longitudinal Study Survey)] Proposed Information Collection (Post-9/11 GI Bill Education Longitudinal Study Survey) Activity... information needed to determine the long-term outcomes of Veterans participating in VBA's Post-9/11GI Bill...

Investigation of 2-stage meta-analysis methods for joint longitudinal and time-to-event data through simulation and real data application.

PubMed

Sudell, Maria; Tudur Smith, Catrin; Gueyffier, François; Kolamunnage-Dona, Ruwanthi

2018-04-15

Joint modelling of longitudinal and time-to-event data is often preferred over separate longitudinal or time-to-event analyses as it can account for study dropout, error in longitudinally measured covariates, and correlation between longitudinal and time-to-event outcomes. The joint modelling literature focuses mainly on the analysis of single studies with no methods currently available for the meta-analysis of joint model estimates from multiple studies. We propose a 2-stage method for meta-analysis of joint model estimates. These methods are applied to the INDANA dataset to combine joint model estimates of systolic blood pressure with time to death, time to myocardial infarction, and time to stroke. Results are compared to meta-analyses of separate longitudinal or time-to-event models. A simulation study is conducted to contrast separate versus joint analyses over a range of scenarios. Using the real dataset, similar results were obtained by using the separate and joint analyses. However, the simulation study indicated a benefit of use of joint rather than separate methods in a meta-analytic setting where association exists between the longitudinal and time-to-event outcomes. Where evidence of association between longitudinal and time-to-event outcomes exists, results from joint models over standalone analyses should be pooled in 2-stage meta-analyses. © 2017 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Strategies for Longitudinal Analysis of the Career Paths of Beginning Teachers: Results from the First through Fourth Waves of the 2007-08 Beginning Teacher Longitudinal Study. Research and Development Report. NCES 2013-336

ERIC Educational Resources Information Center

Gray, Lucinda; Brauen, Marsha

2013-01-01

To learn more about the early career patterns of beginning teachers, the National Center for Education Statistics (NCES) of the Institute of Education Sciences within the U.S. Department of Education undertook the Beginning Teacher Longitudinal Study (BTLS). The ultimate purpose of this report is to develop a strategy for the longitudinal analysis…

Longitudinal axons are guided by Slit/Robo signals from the floor plate.

PubMed

Mastick, Grant S; Farmer, W Todd; Altick, Amy L; Nural, Hikmet Feyza; Dugan, James P; Kidd, Thomas; Charron, Frederic

2010-01-01

Longitudinal axons grow long distances along precise pathways to connect major CNS regions. However, during embryonic development, it remains largely undefined how the first longitudinal axons choose specific positions and grow along them. Here, we review recent evidence identifying a critical role for Slit/Robo signals to guide pioneer longitudinal axons in the embryonic brain stem. These studies indicate that Slit/Robo signals from the floor plate have dual functions: to repel longitudinal axons away from the ventral midline, and also to maintain straight longitudinal growth. These dual functions likely cooperate with other guidance cues to establish the major longitudinal tracts in the brain.

Orotracheal administration of contrast agents: a new protocol for brain tumor targeting.

PubMed

Bianchi, Andrea; Moncelet, Damien; Lux, François; Plissonneau, Marie; Rizzitelli, Silvia; Ribot, Emeline Julie; Tassali, Nawal; Bouchaud, Véronique; Tillement, Olivier; Voisin, Pierre; Crémillieux, Yannick

2015-06-01

The development of new non-invasive diagnostic and therapeutic approaches is of paramount importance in order to improve the outcome of patients with glioblastoma (GBM). In this work we investigated a completely non-invasive pre-clinical protocol to effectively target and detect brain tumors through the orotracheal route, using ultra-small nanoparticles (USRPs) and MRI. A mouse model of GBM was developed. In vivo MRI acquisitions were performed before and after intravenous or orotracheal administration of the nanoparticles to identify and segment the tumor. The accumulation of the nanoparticles in neoplastic lesions was assessed ex vivo through fluorescence microscopy. Before the administration of contrast agents, MR images allowed the identification of the presence of abnormal brain tissue in 73% of animals. After orotracheal or intravenous administration of USRPs, in all the mice an excellent co-localization of the position of the tumor with MRI and histology was observed. The elimination time of the USRPs from the tumor after the orotracheal administration was approximately 70% longer compared with intravenous injection. MRI and USRPs were shown to be powerful imaging tools able to detect, quantify and longitudinally monitor the development of GBMs. The absence of ionizing radiation and high resolution of MRI, along with the complete non-invasiveness and good reproducibility of the proposed protocol, make this technique potentially translatable to humans. To our knowledge, this is the first time that the advantages of a needle-free orotracheal administration route have been demonstrated for the investigation of the pathomorphological changes due to GBMs. Copyright © 2015 John Wiley & Sons, Ltd.

Interdisciplinary Care in Disorders/Differences of Sex Development (DSD): The Psychosocial Component of the DSD – Translational Research Network

PubMed Central

Sandberg, David E.; Gardner, Melissa; Callens, Nina; Mazur, Tom

2017-01-01

Scientific discovery and clinical management strategies for Disorders/Differences of Sex Development (DSD) have advanced in recent years. The 2006 Consensus Statement on Management of Intersex Disorders stated that a mental health component to care is integral to promote positive adaptation, yet the parameters of this element have not been described. The objective of this paper is three-fold: to describe the psychosocial screening protocol adopted by the clinical centers of the DSD-Translational Research Network; to summarize psychosocial data collected at one of the 10 network sites; and to suggest how systematic behavioral health screenings can be employed to tailor care in DSD that results in better health and quality of life outcomes. Steps taken in developing the largely “noncategorical” screening protocol are described. These preliminary findings suggest that DSD, as one category of pediatric chronic conditions, is not associated with marked disturbances of psychosocial adaptation, either for the family or the child; however, screening frequently uncovered “risk factors” for individual families or patients that can potentially be addressed in the context of ongoing clinical care. Administration of the DSD-TRN psychosocial screening protocol was demonstrated to be feasible in the context of interdisciplinary team care and was acceptable to families on a longitudinal basis. The ultimate value of systematic screening will be demonstrated through a tailoring of psychosocial, medical and surgical services, based on this information that enhances the quality of patient and family-centered care and subsequent outcomes. PMID:28574671

Bias in dyslexia screening in a Dutch multicultural population.

PubMed

Verpalen, Anick; Van de Vijver, Fons; Backus, Ad

2018-04-01

We set out to address the adequacy of dyslexia screening in Dutch and non-western immigrant children, using the Dutch Dyslexia Screening Test (DST-NL) and outcomes of the Dutch dyslexia protocol, both of which are susceptible to cultural bias. Using the protocol as standard, we conducted an ROC (Receiver Operating Characteristics) analysis in Dutch and immigrant third, fifth, and seventh graders, combining a cross-sectional and longitudinal design. Sensitivity and specificity increased with grade, but were non-significant for various subtests in the lowest grade, suggesting considerable non-convergence between the two measures. Effective subtests in all grades, presumably not strongly influenced by Cultural Background or Word Lexicon, were One-Minute Reading, Non-Word Reading, and Nonsense Passage Reading. In a multilevel analysis, cultural background, dyslexia diagnosis, parental education, and grade of first assessment were predictors of subtest performance. In a second analysis, Word Lexicon was added as a proxy of knowledge of the Dutch language and culture. After controlling for Word Lexicon, cultural background became significant for most subtests, suggesting the presence of cultural bias. Subtests assessing technical literacy, such as One-Minute-Reading, Non-Word-Reading, One-Minute-Writing, or Two-Minutes-Spelling, showed more convergence between the two assessments. Less-effective subtests were Naming Pictures, Backward Digit Span, and Verbal and Semantic Fluency. It is concluded that the DST-NL and the standard protocol do not show complete convergence, notably in the lower grades in the multilingual pupil group of our cohort, mainly because dyslexia and literacy difficulties are hard to disentangle.

Using a Large Scale Computational Model to Study the Effect of Longitudinal and Radial Electrical Coupling in the Cochlea

NASA Astrophysics Data System (ADS)

Mistrík, Pavel; Ashmore, Jonathan

2009-02-01

We describe a large scale computational model of electrical current flow in the cochlea which is constructed by a flexible Modified Nodal Analysis algorithm to incorporate electrical components representing hair cells and the intercellular radial and longitudinal current flow. The model is used as a laboratory to study the effects of changing longitudinal gap junctional coupling, and shows the way in which cochlear microphonic spreads and tuning is affected. The process for incorporating mechanical longitudinal coupling and feedback is described. We find a difference in tuning and attenuation depending on whether longitudinal or radial couplings are altered.

College Women's Female Friendships: A Longitudinal View

ERIC Educational Resources Information Center

Aleman, Ana M. Martinez

2010-01-01

This article presents a longitudinal qualitative study of the cognitive value of female friendships formed in college and seeks to appraise the meaning of the phenomenon for the participants. To grasp the temporal effects of the longitudinal data in this study, the author examines and assesses the relevant developmental literature, particularly…

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

PubMed

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-05-15

To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

Tulsa 1000: a naturalistic study protocol for multilevel assessment and outcome prediction in a large psychiatric sample.

PubMed

Victor, Teresa A; Khalsa, Sahib S; Simmons, W Kyle; Feinstein, Justin S; Savitz, Jonathan; Aupperle, Robin L; Yeh, Hung-Wen; Bodurka, Jerzy; Paulus, Martin P

2018-01-24

Although neuroscience has made tremendous progress towards understanding the basic neural circuitry underlying important processes such as attention, memory and emotion, little progress has been made in applying these insights to psychiatric populations to make clinically meaningful treatment predictions. The overall aim of the Tulsa 1000 (T-1000) study is to use the NIMH Research Domain Criteria framework in order to establish a robust and reliable dimensional set of variables that quantifies the positive and negative valence, cognition and arousal domains, including interoception, to generate clinically useful treatment predictions. The T-1000 is a naturalistic study that will recruit, assess and longitudinally follow 1000 participants, including healthy controls and treatment-seeking individuals with mood, anxiety, substance use and eating disorders. Each participant will undergo interview, behavioural, biomarker and neuroimaging assessments over the course of 1 year. The study goal is to determine how disorders of affect, substance use and eating behaviour organise across different levels of analysis (molecules, genes, cells, neural circuits, physiology, behaviour and self-report) to predict symptom severity, treatment outcome and long-term prognosis. The data will be used to generate computational models based on Bayesian statistics. The final end point of this multilevel latent variable analysis will be standardised assessments that can be developed into clinical tools to help clinicians predict outcomes and select the best intervention for each individual, thereby reducing the burden of mental disorders, and taking psychiatry a step closer towards personalised medicine. Ethical approval was obtained from Western Institutional Review Board screening protocol #20101611. The dissemination plan includes informing health professionals of results for clinical practice, submitting results to journals for peer-reviewed publication, presenting results at national and international conferences and making the dataset available to researchers and mental health professionals. NCT02450240; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Examining the social determinants of children's developmental health: protocol for building a pan-Canadian population-based monitoring system for early childhood development

PubMed Central

Guhn, Martin; Janus, Magdalena; Enns, Jennifer; Brownell, Marni; Forer, Barry; Duku, Eric; Muhajarine, Nazeem; Raos, Rob

2016-01-01

Introduction Early childhood is a key period to establish policies and practices that optimise children's health and development, but Canada lacks nationally representative data on social indicators of children's well-being. To address this gap, the Early Development Instrument (EDI), a teacher-administered questionnaire completed for kindergarten-age children, has been implemented across most Canadian provinces over the past 10 years. The purpose of this protocol is to describe the Canadian Neighbourhoods and Early Child Development (CanNECD) Study, the aims of which are to create a pan-Canadian EDI database to monitor trends over time in children's developmental health and to advance research examining the social determinants of health. Methods and analysis Canada-wide EDI records from 2004 to 2014 (representing over 700 000 children) will be linked to Canada Census and Income Taxfiler data. Variables of socioeconomic status derived from these databases will be used to predict neighbourhood-level EDI vulnerability rates by conducting a series of regression analyses and latent variable models at provincial/territorial and national levels. Where data are available, we will measure the neighbourhood-level change in developmental vulnerability rates over time and model the socioeconomic factors associated with those trends. Ethics and dissemination Ethics approval for this study was granted by the Behavioural Research Ethics Board at the University of British Columbia. Study findings will be disseminated to key partners, including provincial and federal ministries, schools and school districts, collaborative community groups and the early childhood development research community. The database created as part of this longitudinal population-level monitoring system will allow researchers to associate practices, programmes and policies at school and community levels with trends in developmental health outcomes. The CanNECD Study will guide future early childhood development action and policies, using the database as a tool for formative programme and policy evaluation. PMID:27130168

Realist evaluation of the antiretroviral treatment adherence club programme in selected primary healthcare facilities in the metropolitan area of Western Cape Province, South Africa: a study protocol

PubMed Central

Mukumbang, Ferdinand C; Van Belle, Sara; Marchal, Bruno; Van Wyk, Brian

2016-01-01

Introduction Suboptimal retention in care and poor treatment adherence are key challenges to antiretroviral therapy (ART) in sub-Saharan Africa. Community-based approaches to HIV service delivery are recommended to improve patient retention in care and ART adherence. The implementation of the adherence clubs in the Western Cape province of South Africa was with variable success in terms of implementation and outcomes. The need for operational guidelines for its implementation has been identified. Therefore, understanding the contexts and mechanisms for successful implementation of the adherence clubs is crucial to inform the roll-out to the rest of South Africa. The protocol outlines an evaluation of adherence club intervention in selected primary healthcare facilities in the metropolitan area of the Western Cape Province, using the realist approach. Methods and analysis In the first phase, an exploratory study design will be used. Document review and key informant interviews will be used to elicit the programme theory. In phase two, a multiple case study design will be used to describe the adherence clubs in five contrastive sites. Semistructured interviews will be conducted with purposively selected programme implementers and members of the clubs to assess the context and mechanisms of the adherence clubs. For the programme's primary outcomes, a longitudinal retrospective cohort analysis will be conducted using routine patient data. Data analysis will involve classifying emerging themes using the context-mechanism-outcome (CMO) configuration, and refining the primary CMO configurations to conjectured CMO configurations. Finally, we will compare the conjectured CMO configurations from the cases with the initial programme theory. The final CMOs obtained will be translated into middle range theories. Ethics and dissemination The study will be conducted according to the principles of the declaration of Helsinki (1964). Ethics clearance was obtained from the University of the Western Cape. Dissemination will be done through publications and curation. PMID:27044575

"Old Age and Loneliness: Cross-Sectional and Longitudinal Analyses in the Tampere Longitudinal Study on Aging"

ERIC Educational Resources Information Center

Jylha, Marja

2004-01-01

The purpose of this study was to examine whether older age is associated with increasing loneliness in people aged 60 and over. Data came from TamELSA, a population-based prospective longitudinal study in Tampere, Finland. The followup time was 20 years. Loneliness was measured by a single question--"Do you feel lonely?"--with the…

Higher Weight, Lower Education: A Longitudinal Association between Adolescents' Body Mass Index and Their Subsequent Educational Achievement Level?

ERIC Educational Resources Information Center

Larsen, Junilla K.; Kleinjan, Marloes; Engels, Rutger C. M. E.; Fisher, Jennifer O.; Hermans, Roel

2014-01-01

Background: The purpose of this study was to examine the association between adolescents' body mass index (BMI) z-scores and their subsequent level of schooling, extending previous longitudinal research by using objectively measured weight and height data. Methods: A longitudinal study with 3 study waves (1-year intervals) involving 1248 Dutch…

How Does Longitudinally Measured Maternal Expressed Emotion Affect Internalizing and Externalizing Symptoms of Adolescents from the General Community?

ERIC Educational Resources Information Center

Hale, William W., III; Keijsers, Loes; Klimstra, Theo A.; Raaijmakers, Quinten A. W.; Hawk, Skyler; Branje, Susan J. T.; Frijns, Tom; Wijsbroek, Saskia A. M.; van Lier, Pol; Meeus, Wim H. J.

2011-01-01

Background: In previous studies, maternal expressed emotion (EE) has been found to be a good predictor of the course of adolescent internalizing and externalizing symptoms. However, these studies have been cross-section as opposed to longitudinal. The goal of this study is to examine longitudinal data of perceived maternal EE and adolescent…

High School Longitudinal Study of 2009 (HSLS:09): Base-Year Data File Documentation. NCES 2011-328

ERIC Educational Resources Information Center

Ingels, Steven J.; Pratt, Daniel J.; Herget, Deborah R.; Burns, Laura J.; Dever, Jill A.; Ottem, Randolph; Rogers, James E.; Jin, Ying; Leinwand, Steve

2011-01-01

The High School Longitudinal Study of 2009 (HSLS:09) is the fifth in a series of National Center for Education Statistics (NCES) secondary longitudinal studies. The core research questions for HSLS:09 explore secondary to postsecondary transition plans and the evolution of those plans; the paths into and out of science, technology, engineering,…

A Group of 500 Women Whose Health May Depart Notably From the Norm: Protocol for a Cross-Sectional Survey.

PubMed

Schnelle, Christoph; Minford, Eunice J; McHardy, Vanessa; Keep, Jane

2017-11-23

Longitudinal studies of women's health often seek to identify predictors of good health. Research has shown that following simple guidelines can halve women's mortality. The ongoing Australian Longitudinal Study of Women's Health (ALSWH) shows that Australian women are getting better at reducing their smoking and alcohol use, and are generally diligent about attending recommended health screenings, but are becoming less successful at dealing with obesity. There are communities of women who live unusually healthy lives (Rosetans, Seventh-Day Adventists, traditional Japanese women), but their lifestyles are unlikely to be adopted widely. Universal Medicine (UM) is a complementary-to-medicine approach that emphasizes personal empowerment and the importance of menstrual health symptoms. This survey investigates whether the approximately 500 women associated with UM exhibit health status significantly above the norm. As part of this investigation, questions for a newly developed menstrual attitudes questionnaire will also be evaluated. A quantitative cross-sectional survey of women in a UM cohort was designed with the help of three focus groups of women at three life stages: in menses, peri-menopausal, and menopausal. The menstrual attitudes portion of the survey incorporates the insights of these women regarding female health issues. The survey also includes 41 questions taken from the ALSWH. Focus groups generated additional questions about symptoms experienced and attitudes toward female health issues. ALSWH questions, including a range of health scales like the Short Form 36 (SF-36), Center for Epidemiologic Studies Depression Scale, Perceived Control Scale, Kessler Psychological Distress Scale, and the Multi-Item Summed Score for Perceived Stress, along with questions about experienced major health events, were investigated and incorporated if considered suitable. The validity of the menstrual attitudes questionnaire will be evaluated with Cohen's kappa. ALSWH respondents and UM participants will be compared, using unweighted regression or regression weighted or normalized by age, education, and interest in alternative treatments (to increase comparability), as appropriate. Analyses will determine whether UM-related variables (being a UM participant, length of UM participation, number of UM events attended) are associated with: differences in the number of major health events and health symptoms experienced; SF-36 physical and mental health scores; body mass index; and consumption of alcohol, tobacco, sugar, salt, caffeine, and dairy. If women in the UM cohort are truly in substantially better health than the norm, further investigations may be worthwhile to see whether UM plays a causal role, and whether the women's practices are generalizable. ©Christoph Schnelle, Eunice J Minford, Vanessa McHardy, Jane Keep. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 23.11.2017.

Rehabilitation After Hamstring-Strain Injury Emphasizing Eccentric Strengthening at Long Muscle Lengths: Results of Long-Term Follow-Up.

PubMed

Tyler, Timothy F; Schmitt, Brandon M; Nicholas, Stephen J; McHugh, Malachy P

2017-04-01

Hamstring-strain injuries have a high recurrence rate. To determine if a protocol emphasizing eccentric strength training with the hamstrings in a lengthened position resulted in a low recurrence rate. Longitudinal cohort study. Sports-medicine physical therapy clinic. Fifty athletes with hamstring-strain injury (age 36 ± 16 y; 30 men, 20 women; 3 G1, 43 G2, 4 G3; 25 recurrent injuries) followed a 3-phase rehabilitation protocol emphasizing eccentric strengthening with the hamstrings in a lengthened position. Injury recurrence; isometric hamstring strength at 80°, 60°, 40°, and 20° knee flexion in sitting with the thigh flexed to 40° above the horizontal and the seat back at 90° to the horizontal (strength tested before return to sport). Four of the 50 athletes sustained reinjuries between 3 and 12 mo after return to sport (8% recurrence rate). The other 42 athletes had not sustained a reinjury at an average of 24 ± 12 mo after return to sport. Eight noncompliant athletes did not complete the rehabilitation and returned to sport before initiating eccentric strengthening in the lengthened state. All 4 reinjuries occurred in these noncompliant athletes. At time of return to sport, compliant athletes had full restoration of strength while noncompliant athletes had significant hamstring weakness, which was progressively worse at longer muscle lengths (compliance × side × angle P = .006; involved vs noninvolved at 20°, compliant 7% stronger, noncompliant 43% weaker). Compliance with rehabilitation emphasizing eccentric strengthening with the hamstrings in a lengthened position resulted in no reinjuries.

Study protocol for a longitudinal study evaluating the impact of rape on women's health and their use of health services in South Africa.

PubMed

Abrahams, Naeemah; Seedat, Soraya; Lombard, Carl; Kengne, Andre P; Myers, Bronwyn; Sewnath, Alesha; Mhlongo, Shibe; Ramjee, Gita; Peer, Nasheeta; Garcia-Moreno, Claudia; Jewkes, Rachel

2017-09-29

South Africa is a country known for its high levels of HIV infection and sexual violence. Although the interface between gender-based violence, HIV and mental health has been described, there are substantial gaps in knowledge of the medium-term and long-term health impact. The 2010 Global Burden of Disease study excluded many health outcomes associated with rape and other forms of gender-based violence because systematic reviews revealed huge gaps in data and poor evidence of health effects. This study aims to describe the incidence and attributable burden of physical and mental health problems (including HIV acquisition) in adult women over a 2-year postrape period, through comparison with a cohort of women who have not been raped. The study will substantially advance our understanding of the impact of rape and will generate robust data to assist in the development of postrape health services and the delivery of evidence-based care. This longitudinal study seeks to recruit 1008 rape-exposed and 1008 rape non-exposed women. Women were recruited from health services, and assessments were carried out at baseline, 3, 6, 9, 12, 18 and 24 months. Outcome measures include exposure to risk factors; mental health status; cardio-metabolic risks; and biomarkers for HIV, sexually transmitted infections, pregnancy and stress. The primary analysis will be to compare HIV incidence in the two groups using log-rank tests. Appropriate models to predict health outcomes over time will also be applied. The South African Medical Research Council's Ethics Committee approved the study. As rape is a key element of the study, the safety and protection of participants guides the research process. We will adopt a research uptake strategy to ensure dissemination to policy makers, service providers and advocacy groups. Peer-reviewed journal articles will be published. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Longitudinal joint study.

DOT National Transportation Integrated Search

2001-09-01

In previous years there has been a problem with longitudinal joint : deterioration, due in part to poor construction techniques. : The degradation of the longitudinal joints has increased the cost of : maintaining these projects and caused unnecessar...

Novel and emerging strategies for longitudinal data collection.

PubMed

Udtha, Malini; Nomie, Krystle; Yu, Erica; Sanner, Jennifer

2015-03-01

To describe novel and emerging strategies practiced globally in research to improve longitudinal data collection. In research studies, numerous strategies such as telephone interviews, postal mailing, online questionnaires, and electronic mail are traditionally utilized in longitudinal data collection. However, due to technological advances, novel and emerging strategies have been applied to longitudinal data collection, such as two-way short message service, smartphone applications (or "apps"), retrieval capabilities applied to the electronic medical record, and an adapted cloud interface. In this review, traditional longitudinal data collection strategies are briefly described, emerging and novel strategies are detailed and explored, and information regarding the impact of novel methods on participant response rates, the timeliness of participant responses, and cost is provided. We further discuss how these novel and emerging strategies affect longitudinal data collection and advance research, specifically nursing research. Evidence suggests that the novel and emerging longitudinal data collection strategies discussed in this review are valuable approaches to consider. These strategies facilitate collecting longitudinal research data to better understand a variety of health-related conditions. Future studies, including nursing research, should consider using novel and emerging strategies to advance longitudinal data collection. A better understanding of novel and emerging longitudinal data collection strategies will ultimately improve longitudinal data collection as well as foster research efforts. Nurse researchers, along with all researchers, must be aware of and consider implementing novel and emerging strategies to ensure future healthcare research success. © 2014 Sigma Theta Tau International.

Bayesian Modeling of NMR Data: Quantifying Longitudinal Relaxation in Vivo, and in Vitro with a Tissue-Water-Relaxation Mimic (Crosslinked Bovine Serum Albumin).

PubMed

Meinerz, Kelsey; Beeman, Scott C; Duan, Chong; Bretthorst, G Larry; Garbow, Joel R; Ackerman, Joseph J H

2018-01-01

Recently, a number of MRI protocols have been reported that seek to exploit the effect of dissolved oxygen (O 2 , paramagnetic) on the longitudinal 1 H relaxation of tissue water, thus providing image contrast related to tissue oxygen content. However, tissue water relaxation is dependent on a number of mechanisms, and this raises the issue of how best to model the relaxation data. This problem, the model selection problem, occurs in many branches of science and is optimally addressed by Bayesian probability theory. High signal-to-noise, densely sampled, longitudinal 1 H relaxation data were acquired from rat brain in vivo and from a cross-linked bovine serum albumin (xBSA) phantom, a sample that recapitulates the relaxation characteristics of tissue water in vivo . Bayesian-based model selection was applied to a cohort of five competing relaxation models: (i) monoexponential, (ii) stretched-exponential, (iii) biexponential, (iv) Gaussian (normal) R 1 -distribution, and (v) gamma R 1 -distribution. Bayesian joint analysis of multiple replicate datasets revealed that water relaxation of both the xBSA phantom and in vivo rat brain was best described by a biexponential model, while xBSA relaxation datasets truncated to remove evidence of the fast relaxation component were best modeled as a stretched exponential. In all cases, estimated model parameters were compared to the commonly used monoexponential model. Reducing the sampling density of the relaxation data and adding Gaussian-distributed noise served to simulate cases in which the data are acquisition-time or signal-to-noise restricted, respectively. As expected, reducing either the number of data points or the signal-to-noise increases the uncertainty in estimated parameters and, ultimately, reduces support for more complex relaxation models.

Longitudinal in vivo microcomputed tomography of mouse lungs: No evidence for radiotoxicity

PubMed Central

Vande Velde, Greetje; De Langhe, Ellen; Poelmans, Jennifer; Bruyndonckx, Peter; d'Agostino, Emiliano; Verbeken, Erik; Bogaerts, Ria; Himmelreich, Uwe

2015-01-01

Before microcomputed tomography (micro-CT) can be exploited to its full potential for longitudinal monitoring of transgenic and experimental mouse models of lung diseases, radiotoxic side effects such as inflammation or fibrosis must be considered. We evaluated dose and potential radiotoxicity to the lungs for long-term respiratory-gated high-resolution micro-CT protocols. Free-breathing C57Bl/6 mice underwent four different retrospectively respiratory gated micro-CT imaging schedules of repeated scans during 5 or 12 wk, followed by ex vivo micro-CT and detailed histological and biochemical assessment of lung damage. Radiation exposure, dose, and absorbed dose were determined by ionization chamber, thermoluminescent dosimeter measurements and Monte Carlo calculations. Despite the relatively large radiation dose delivered per micro-CT acquisition, mice did not show any signs of radiation-induced lung damage or fibrosis when scanned weekly during 5 and up to 12 wk. Doubling the scanning frequency and once tripling the radiation dose as to mimic the instant repetition of a failed scan also stayed without detectable toxicity after 5 wk of scanning. Histological analyses confirmed the absence of radiotoxic damage to the lungs, thereby demonstrating that long-term monitoring of mouse lungs using high-resolution micro-CT is safe. This opens perspectives for longitudinal monitoring of (transgenic) mouse models of lung diseases and therapeutic response on an individual basis with high spatial and temporal resolution, without concerns for radiation toxicity that could potentially influence the readout of micro-CT-derived lung biomarkers. This work further supports the introduction of micro-CT for routine use in the preclinical pulmonary research field where postmortem histological approaches are still the gold standard. PMID:26024893

Does adopting a prenatal substance use protocol reduce racial disparities in CPS reporting related to maternal drug use? A California case study.

PubMed

Roberts, S C M; Zahnd, E; Sufrin, C; Armstrong, M A

2015-02-01

This study examined whether adopting a standardized prenatal substance use protocol (protocol) in a hospital labor and delivery unit reduced racial disparities in reporting to child protective services (CPS) related to maternal drug use during pregnancy. This study used an interrupted time series design with a non-equivalent control. One hospital adopted a protocol and another hospital group serving a similar geographic population did not change protocols. Data on CPS reporting disparities from these hospitals over 3.5 years were analyzed using segmented regression. In the hospital that adopted the protocol, almost five times more black than white newborns were reported during the study period. Adopting the protocol was not associated with reduced disparities. Adopting a protocol cannot be assumed to reduce CPS reporting disparities. Efforts to encourage hospitals to adopt protocols as a strategy to reduce disparities may be misguided. Other strategies to reduce disparities are needed.

Promoting physical activity and health literacy: study protocol for a longitudinal, mixed methods evaluation of a cross-provider workplace-related intervention in Germany (The AtRisk study).

PubMed

Schaller, Andrea; Dejonghe, Lea; Alayli-Goebbels, Adrienne; Biallas, Bianca; Froboese, Ingo

2016-07-22

Physical activity and health literacy are topics of utmost importance in the prevention of chronic diseases. The present article describes the study protocol for evaluating a cross-provider workplace-related intervention promoting physical activity and health literacy. The RE-AIM Framework will be the conceptual framework of the AtRisk study. A controlled natural experiment and a qualitative study will be conducted. The cross-provider intervention is based on the cooperation of the German Pension Fund Rhineland and cooperating German Statutory Health Insurances. It combines two components: a behavior-oriented lifestyle intervention and the assignment of a health coach. The single-provider intervention only includes the behavior-oriented lifestyle intervention. The quantitative study (natural experiment) encompasses three measuring points (T0 = start of the behavior-oriented lifestyle intervention (baseline); T1 = end of the behavior-oriented lifestyle intervention (16 weeks); T2 = 6 month follow-up) and will compare the effectiveness of the cross-provider workplace-related intervention compared with the single provider intervention. Participants are employees with health related risk factors. ANCOVA will be used to evaluate the effect of the intervention on the outcome variables leisure time physical (primary outcome) activity and health literacy (secondary outcome). The qualitative study comprises semi-structured interviews, systematic field notes of stakeholder meetings and document analyses. The AtRisk study will contribute towards the claim for cross-provider interventions and workplace-related approaches described in the new Preventive Health Care Act. The results of this study will inform providers, payers and policy makers about the effectiveness of a cross-provider workplace-related lifestyle intervention compared to a single-provider intervention. Beyond, the study will identify challenges for implementing cross-provider preventive interventions. With respect to the sustainability of preventive interventions the AtRisk study will give insight in the expectations and needs on health coaching from the perspective of different stakeholders. DRKS00010693 .

Work-related heat stress concerns in automotive industries: a case study from Chennai, India

PubMed Central

Ayyappan, Ramalingam; Sankar, Sambandam; Rajkumar, Paramasivan; Balakrishnan, Kalpana

2009-01-01

Background Work-related heat stress assessments, the quantification of thermal loads and their physiological consequences have mostly been performed in non-tropical developed country settings. In many developing countries (many of which are also tropical), limited attempts have been made to create detailed job-exposure profiles for various sectors. We present here a case study from Chennai in southern India that illustrates the prevalence of work-related heat stress in multiple processes of automotive industries and the efficacy of relatively simple controls in reducing prevalence of the risk through longitudinal assessments. Methods We conducted workplace heat stress assessments in automotive and automotive parts manufacturing units according to the protocols recommended by NIOSH, USA. Sites for measurements included indoor locations with process-generated heat exposure, indoor locations without direct process-generated heat exposure and outdoor locations. Nearly 400 measurements of heat stress were made over a four-year period at more than 100 locations within eight units involved with automotive or automotive parts manufacturing in greater Chennai metropolitan area. In addition, cross-sectional measurements were made in select processes of glass manufacturing and textiles to estimate relative prevalence of heat stress. Results Results indicate that many processes even in organised large-scale industries have yet to control heat stress-related hazards adequately. Upwards of 28% of workers employed in multiple processes were at risk of heat stress-related health impairment in the sectors assessed. Implications of longitudinal baseline data for assessing efficacy of interventions as well as modelling potential future impacts from climate change (through contributions from worker health and productivity impairments consequent to increases in ambient temperature) are described. Conclusions The study re-emphasises the need for recognising heat stress as an important occupational health risk in both formal and informal sectors in India. Making available good baseline data is critical for estimating future impacts. PMID:20052426

Clinical effects of blood donor characteristics in transfusion recipients: protocol of a framework to study the blood donor–recipient continuum

PubMed Central

Chassé, Michaël; McIntyre, Lauralyn; Tinmouth, Alan; Acker, Jason; English, Shane W; Knoll, Greg; Forster, Alan; Shehata, Nadine; Wilson, Kumanan; van Walraven, Carl; Ducharme, Robin; Fergusson, Dean A

2015-01-01

Introduction When used appropriately, transfusion of red blood cells (RBCs) is a necessary life-saving therapy. However, RBC transfusions have been associated with negative outcomes such as infection and organ damage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource. This study will create a framework to analyse the influence of blood donor characteristics on recipient outcomes. Methods and analysis We will conduct a multisite, longitudinal cohort study using blood donor data routinely collected by Canadian Blood Services, and recipient data from health administrative databases. Our project will include a thorough validation of primary data, the linkage of various databases into one large longitudinal database, an in-depth epidemiological analysis and a careful interpretation and dissemination of the results to assist the decision-making process of clinicians, researchers and policymakers in transfusion medicine. Our primary donor characteristic will be age of blood donors and our secondary donor characteristics will be donor–recipient blood group compatibility and blood donor sex. Our primary recipient outcome will be a statistically appropriate survival analysis post-RBC transfusion up to a maximum of 8 years. Our secondary recipient outcomes will include 1-year, 2-year and 5-year mortality; hospital and intensive care unit length of stay; rehospitalisation; new cancer and cancer recurrence rate; infection rate; new occurrence of myocardial infarctions and need for haemodialysis. Ethics and dissemination Our results will help determine whether we need to tailor transfusion based on donor characteristics, and perhaps this will improve patient outcome. Our results will be customised to target the different stakeholders involved with blood transfusions and will include presentations, peer-reviewed publications and the use of the dissemination network of blood supply organisations. We obtained approval from the Research Ethics boards and privacy offices of all involved institutions. PMID:25600255

Uncertainty in assessment of radiation-induced diffusion index changes in individual patients

NASA Astrophysics Data System (ADS)

Nazem-Zadeh, Mohammad-Reza; Chapman, Christopher H.; Lawrence, Theodore S.; Tsien, Christina I.; Cao, Yue

2013-06-01

The purpose of this study is to evaluate repeatability coefficients of diffusion tensor indices to assess whether longitudinal changes in diffusion indices were true changes beyond the uncertainty for individual patients undergoing radiation therapy (RT). Twenty-two patients who had low-grade or benign tumors and were treated by partial brain radiation therapy (PBRT) participated in an IRB-approved MRI protocol. The diffusion tensor images in the patients were acquired pre-RT, week 3 during RT, at the end of RT, and 1, 6, and 18 months after RT. As a measure of uncertainty, repeatability coefficients (RC) of diffusion indices in the segmented cingulum, corpus callosum, and fornix were estimated by using test-retest diffusion tensor datasets from the National Biomedical Imaging Archive (NBIA) database. The upper and lower limits of the 95% confidence interval of the estimated RC from the test and retest data were used to evaluate whether the longitudinal percentage changes in diffusion indices in the segmented structures in the individual patients were beyond the uncertainty and thus could be considered as true radiation-induced changes. Diffusion indices in different white matter structures showed different uncertainty ranges. The estimated RC for fractional anisotropy (FA) ranged from 5.3% to 9.6%, for mean diffusivity (MD) from 2.2% to 6.8%, for axial diffusivity (AD) from 2.4% to 5.5%, and for radial diffusivity (RD) from 2.9% to 9.7%. Overall, 23% of the patients treated by RT had FA changes, 44% had MD changes, 50% had AD changes, and 50% had RD changes beyond the uncertainty ranges. In the fornix, 85.7% and 100% of the patients showed changes beyond the uncertainty range at 6 and 18 months after RT, demonstrating that radiation has a pronounced late effect on the fornix compared to other segmented structures. It is critical to determine reliability of a change observed in an individual patient for clinical decision making. Assessments of the repeatability and confidence interval of diffusion tensor measurements in white matter structures allow us to determine the true longitudinal change in individual patients.

Does simulated walking cause gapping of meniscal repairs?

PubMed

McCulloch, Patrick C; Jones, Hugh L; Hamilton, Kendall; Hogen, Michael G; Gold, Jonathan E; Noble, Philip C

2016-12-01

The objective of rehabilitation following meniscal repair is to promote healing by limiting stresses on repairs, while simultaneously preserving muscle strength and joint motion. Both protective protocols limiting weight bearing and accelerated which do not, have shown clinical success. This study assesses the effects of physiologic gait loading on the kinematic behavior of a repaired medial meniscus. The medial menisci of eight fresh cadaveric knees were implanted with arrays of six 0.8-1.0 mm beads. Pneumatic actuators delivered muscle loads and forces on the knee as each specimen was subjected to a simulated stance phase of gait. Meniscus motion was measured at loading response, mid stance, and toe-off positions. Measurements were performed using biplanar radiography and RSA, with each knee: (a) intact, (b) with posterior longitudinal tear, and (c) after inside-out repair. The tissue spanning the site of the longitudinal tear underwent compression rather than gapping open in all states (intact [I], torn [T] and repaired [R] states). Average compression at three sites along the posterior half of the meniscus was: posterior horn -0.20 ± 0.08 mm [I], -0.39 ± 0.10 mm [T], and -0.20 ± 0.06 mm [R] (p = 0.15); junction of posterior horn and body -0.11 ± 0.12 mm [I], -0.21 ± 12 mm [T], -0.17 ± 0.09 mm [R] (p = 0.87); and adjacent to the medial collateral ligament -0.07 ± 0.06 mm [I], -0.29 ± 0.13 mm [T], -0.07 ± 0.17 mm [R] (p = 0.35). The entire meniscus translated posteriorly from mid-stance to toe off. Displacement was greatest in the torn state compared to intact, but was not restored to normal levels after repair. The edges of a repaired longitudinal medial meniscal tear undergo compression, not gapping, during simulated gait.

Substance Use as a Longitudinal Predictor of the Perpetration of Teen Dating Violence

ERIC Educational Resources Information Center

Temple, Jeff R.; Shorey, Ryan C.; Fite, Paula; Stuart, Gregory L.; Le, Vi Donna

2013-01-01

The prevention of teen dating violence is a major public health priority. However, the dearth of longitudinal studies makes it difficult to develop programs that effectively target salient risk factors. Using a school-based sample of ethnically diverse adolescents, this longitudinal study examined whether substance use (alcohol, marijuana, and…

Transformative Learning in Medical Education: Context Matters, a South Australian Longitudinal Study

ERIC Educational Resources Information Center

Greenhill, Jenenne; Richards, Janet Noreen; Mahoney, Sarah; Campbell, Narelle; Walters, Lucie

2018-01-01

This longitudinal study followed the clinical learning journey of 20 medical students over 4 years, from the beginning of their clinical immersion, through one of the three different clinical placement models: block rotation, longitudinal integrated clerkship, or community- and hospital-integrated learning, and then into Year 4 and the intern year…

Executive Function in Early Childhood: Longitudinal Measurement Invariance and Developmental Change

ERIC Educational Resources Information Center

Willoughby, Michael T.; Wirth, R. J.; Blair, Clancy B.

2012-01-01

This study tested the longitudinal measurement invariance and developmental changes of a newly developed battery of executive function (EF) tasks for use in early childhood. The battery was administered in the Family Life Project--a prospective longitudinal study (N = 1,292) of families who were oversampled from low-income and African American…

Use of Missing Data Methods in Longitudinal Studies: The Persistence of Bad Practices in Developmental Psychology

ERIC Educational Resources Information Center

Jelicic, Helena; Phelps, Erin; Lerner, Richard M.

2009-01-01

Developmental science rests on describing, explaining, and optimizing intraindividual changes and, hence, empirically requires longitudinal research. Problems of missing data arise in most longitudinal studies, thus creating challenges for interpreting the substance and structure of intraindividual change. Using a sample of reports of longitudinal…

Cultural Orientation Trajectories and Substance Use: Findings from a Longitudinal Study of Mexican-Origin Youth

ERIC Educational Resources Information Center

Cruz, Rick A.; King, Kevin M.; Cauce, Ana M.; Conger, Rand D.; Robins, Richard W.

2017-01-01

Cultural adaptation may influence Latino youth substance use (SU) development, yet few longitudinal studies have examined cultural change over time and adolescent SU outcomes. Using longitudinal data collected annually across ages 10-16 from 674 Mexican-origin youth (50% female), the authors characterized cultural adaptation patterns for language…

A Longitudinal Study of Children's Social Behaviors and Their Causal Relationship to Reading Growth

ERIC Educational Resources Information Center

Lim, Hyo Jin; Kim, Junyeop

2011-01-01

This paper aims at investigating the causal effects of social behaviors on subsequent reading growth in elementary school, using the "Early Childhood Longitudinal Study-Kindergarten" ("ECLS-K") data. The sample was 8,869 subjects who provided longitudinal measures of reading IRT scores from kindergarten (1998-1999) to fifth…

Changes in HRM in Europe: A Longitudinal Comparative Study among 18 European Countries

ERIC Educational Resources Information Center

Nikandrou, Irene; Apospori, Eleni; Papalexandris, Nancy

2005-01-01

Purpose: To examine HRM strategies and practices and HRM position within organizations in various cultural, economic and sociopolitical contexts from a longitudinal perspective. Design/methodology/approach: The study uses the 1995 and 1999 Cranet data in a longitudinal methodological framework to explore the changes and trends in 18 European…

The Multiple-Institution Database for Investigating Engineering Longitudinal Development: An Experiential Case Study of Data Sharing and Reuse

ERIC Educational Resources Information Center

Ohland, Matthew W.; Long, Russell A.

2016-01-01

Sharing longitudinal student record data and merging data from different sources is critical to addressing important questions being asked of higher education. The Multiple-Institution Database for Investigating Engineering Longitudinal Development (MIDFIELD) is a multi-institution, longitudinal, student record level dataset that is used to answer…

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement

PubMed Central

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-01-01

Objective To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. Methods We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Results Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. Conclusions The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future. PMID:29872509

Optimizing the high-resolution manometry (HRM) study protocol.

PubMed

Patel, A; Ding, A; Mirza, F; Gyawali, C P

2015-02-01

Intolerance of the esophageal manometry catheter may prolong high-resolution manometry (HRM) studies and increase patient distress. We assessed the impact of obtaining the landmark phase at the end of the study when the patient has acclimatized to the HRM catheter. 366 patients (mean age 55.4 ± 0.8 years, 62.0% female) undergoing esophageal HRM over a 1-year period were studied. The standard protocol consisted of the landmark phase, 10 5 mL water swallows 20-30 s apart, and multiple rapid swallows where 4-6 2 mL swallows were administered in rapid succession. The modified protocol consisted of the landmark phase at the end of the study after test swallows. Study duration, technical characteristics, indications, and motor findings were compared between standard and modified protocols. Of the 366 patients, 89.6% underwent the standard protocol (study duration 12.9 ± 0.3 min). In 10.4% with poor catheter tolerance undergoing the modified protocol, study duration was significantly longer (15.6 ± 1.0 min, p = 0.004) despite similar duration of study maneuvers. Only elevated upper esophageal sphincter basal pressures at the beginning of the study segregated modified protocol patients. The 95th percentile time to landmark phase in the standard protocol patients was 6.1 min; as many as 31.4% of modified protocol patients could not obtain their first study maneuver within this period (p = 0.0003). Interpretation was not impacted by shifting the landmark phase to the end of the study. Modification of the HRM study protocol with the landmark phase obtained at the end of the study optimizes study duration without compromising quality. © 2014 John Wiley & Sons Ltd.

Autism Spectrum Disorder and Autistic Traits in the Avon Longitudinal Study of Parents and Children: Precursors and Early Signs

ERIC Educational Resources Information Center

Bolton, Patrick F.; Golding, Jean; Emond, Alan; Steer, Colin D.

2012-01-01

Objective: To chart the emergence of precursors and early signs of autism spectrum disorder (ASD) and autistic traits in the Avon Longitudinal Study of Parents and Children, a prospective longitudinal cohort study of the surviving offspring of 14,541 pregnant women from southwestern England with an expected delivery date between April 1991 and…

An Analysis of Pedagogical Moves for Facilitating the Development of In-Service Middle-School Mathematics Teachers' Recognition of Reasoning

ERIC Educational Resources Information Center

Cipriani, Phyllis J.

2017-01-01

A constructivist approach for teaching and learning mathematics was the foundation for a longitudinal study at Rutgers University in 1987 (Maher, 2011). One of the objectives of the longitudinal study was to provide an environment where students solve problems in collaborative groups (Maher, 2011). Videos from the longitudinal study are stored in…

The Etiology of Variation in Language Skills Changes with Development: A Longitudinal Twin Study of Language from 2 to 12 Years

ERIC Educational Resources Information Center

Hayiou-Thomas, Marianna E.; Dale, Philip S.; Plomin, Robert

2012-01-01

The present study is the first long-term longitudinal examination of the etiology of individual differences in language from early childhood through to adolescence. We applied a multivariate latent factor genetic model to longitudinal data from the Twins Early Development Study in order to (a) compare the magnitude of genetic and environmental…

Retention of Children and Their Families in the Longitudinal Outcome Study of the Comprehensive Community Mental Health Services for Children and Their Families Program: A Multilevel Analysis

ERIC Educational Resources Information Center

Gebreselassie, Tesfayi; Stephens, Robert L.; Maples, Connie J.; Johnson, Stacy F.; Tucker, Alyce L.

2014-01-01

Predictors of retention of participants in a longitudinal study and heterogeneity between communities were investigated using a multilevel logistic regression model. Data from the longitudinal outcome study of the national evaluation of the Comprehensive Community Mental Health Services for Children and Their Families program and information on…

Characteristics of At-Risk Students in NELS:88. National Education Longitudinal Study of 1988. Statistical Analysis Report. Contractor Report. NCES 92-042

ERIC Educational Resources Information Center

Kaufman, Phillip; Bradbury, Denise

1992-01-01

The National Education Longitudinal Study of 1988 (NELS:88) is a large-scale, national longitudinal study designed and sponsored by the National Center for Education Statistics (NCES), with support from other government agencies. Beginning in the spring of 1988 with a cohort of eighth graders (25,000) attending public and private schools across…

Using Hand Grip Force as a Correlate of Longitudinal Acceleration Comfort for Rapid Transit Trains

PubMed Central

Guo, Beiyuan; Gan, Weide; Fang, Weining

2015-01-01

Longitudinal acceleration comfort is one of the essential metrics used to evaluate the ride comfort of train. The aim of this study was to investigate the effectiveness of using hand grip force as a correlate of longitudinal acceleration comfort of rapid transit trains. In the paper, a motion simulation system was set up and a two-stage experiment was designed to investigate the role of the grip force on the longitudinal comfort of rapid transit trains. The results of the experiment show that the incremental grip force was linearly correlated with the longitudinal acceleration value, while the incremental grip force had no correlation with the direction of the longitudinal acceleration vector. The results also show that the effects of incremental grip force and acceleration duration on the longitudinal comfort of rapid transit trains were significant. Based on multiple regression analysis, a step function model was established to predict the longitudinal comfort of rapid transit trains using the incremental grip force and the acceleration duration. The feasibility and practicably of the model was verified by a field test. Furthermore, a comparative analysis shows that the motion simulation system and the grip force based model were valid to support the laboratory studies on the longitudinal comfort of rapid transit trains. PMID:26147730

Protocol for a 1-year prospective, longitudinal cohort study of patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy: the BARI-LIFESTYLE observational study.

PubMed

Jassil, Friedrich C; Carnemolla, Alisia; Kingett, Helen; Paton, Bruce; O'Keeffe, Aidan G; Doyle, Jacqueline; Morris, Stephen; Lewis, Neville; Kirk, Amy; Pucci, Andrea; Chaiyasoot, Kusuma; Batterham, Rachel L

2018-03-16

Roux-en-Y gastric bypass and sleeve gastrectomy are the two most common bariatric surgery performed in the UK that result in comparable weight loss and remission of obesity-associated comorbidities. However, there is a paucity of studies examining the impact of these procedures on body composition, physical activity levels, sedentary behaviour, physical function and strength, dietary intake, health-related quality of life and costs. The BARI-LIFESTYLE observational study is a 1-year prospective, longitudinal cohort study within a real-world routine clinical care setting aiming to recruit 100 patients with severe obesity undergoing either primary Roux-en-Y gastric bypass or sleeve gastrectomy from two bariatric centres in London, UK. Participants will be followed up four times during the study period; presurgery baseline (T0) and at 3 (T1), 6 (T2) and 12 months (T3) postsurgery. In addition to the standard follow-up investigations, assessments including dual-energy X-ray absorptiometry scan, bioelectric impedance analysis, 6 min walk test, sit-to-stand test and handgrip test will be undertaken together with completion of questionnaires. Physical activity levels and sedentary behaviour will be assessed using accelerometer, and dietary intake will be recorded using a 3-day food diary. Outcome measures will include body weight, body fat mass, lean muscle mass, bone mineral density, physical activity levels, sedentary behaviour, physical function and strength, dietary intake, health-related quality of life, remission of comorbidities, healthcare resource utilisation and costs. This study has been reviewed and given a favourable ethical opinion by London-Dulwich Research Ethics Committee (17/LO/0950). The results will be presented to stakeholder groups locally, nationally and internationally and published in peer-reviewed medical journals. The lay-person summary of the findings will be published on the Centre for Obesity Research, University College London website (http://www.ucl.ac.uk/obesity). © 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.

Maintaining Superior Follow-Up Rates in a Longitudinal Study: Experiences from the College Life Study

PubMed Central

Vincent, Kathryn B.; Kasperski, Sarah J.; Caldeira, Kimberly M.; Garnier-Dykstra, Laura M.; Pinchevsky, Gillian M.; O’Grady, Kevin E.; Arria, Amelia M.

2011-01-01

Longitudinal studies are often considered to be a gold standard for research, but the operational management of such studies is not often discussed in detail; this paper describes strategies used to track and maintain high levels of participation in a longitudinal study involving annual personal interviews with a cohort of 1,253 undergraduates (first-time, first-year students at time of enrollment) at a large public mid-Atlantic university. PMID:22247739

The Behavior of TCP and Its Extensions in Space

NASA Technical Reports Server (NTRS)

Wang, Ruhai; Horan, Stephen

2001-01-01

The performance of Transmission Control Protocol (TCP) in space has been examined from the observations of simulation and experimental tests for several years at National Aeronautics and Space Administration (NASA), Department of Defense (DoD) and universities. At New Mexico State University (NMSU), we have been concentrating on studying the performance of two protocol suites: the file transfer protocol (ftp) running over Transmission Control Protocol/Internet Protocol (TCP/IP) stack and the file protocol (fp) running over the Space Communications Protocol Standards (SCPS)-Transport Protocol (TP) developed under the Consultative Committee for Space Data Systems (CCSDS) standards process. SCPS-TP is considered to be TCP's extensions for space communications. This dissertation experimentally studies the behavior of TCP and SCPS-TP by running the protocol suites over both the Space-to-Ground Link Simulator (SGLS) test-bed and realistic satellite link. The study concentrates on comparing protocol behavior by plotting the averaged file transfer times for different experimental configurations and analyzing them using Statistical Analysis System (SAS) based procedures. The effects of different link delays and various Bit-Error-Rates (BERS) on each protocol performance are also studied and linear regression models are built for experiments over SGLS test-bed to reflect the relationships between the file transfer time and various transmission conditions.

COBA-Cohort: a prospective cohort of HIV-negative men who have sex with men, attending community-based HIV testing services in five European countries (a study protocol).

PubMed

Lorente, Nicolas; Fernàndez-López, Laura; Fuertes, Ricardo; Rojas Castro, Daniela; Pichon, François; Cigan, Bojan; Chanos, Sophocles; Meireles, Paula; Lucas, Raquel; Morel, Stéphane; Slaaen Kaye, Per; Agustí, Cristina; Klavs, Irena; Platteau, Tom; Casabona, Jordi

2016-07-13

Community-based voluntary counselling and testing (CBVCT) services for men who have sex with men (MSM) can reach those most-at-risk and provide an environment for gay men that is likely to be non-stigmatising. Longitudinal data on the behaviour of HIV-negative MSM are scarce in Europe. The aim of this protocol, developed during the Euro HIV Early Diagnosis And Treatment (EDAT) project, is to implement a multicentre community-based cohort of HIV-negative MSM attending 15 CBVCT services in 5 European countries. (1) To describe the patterns of CBVCT use, (2) to estimate HIV incidence, and to identify determinants of (3) HIV seroconversion and (4) HIV and/or sexually transmitted infection (STI) test-seeking behaviour. All MSM aged 18 years or over and who had a negative HIV test result are invited to participate in the COmmunity-BAsed Cohort (COBA-Cohort). Study enrolment started in February 2015, and is due to continue for at least 12 months at each study site. Follow-up frequency depends on the testing recommendations in each country (at least 1 test per year). Sociodemographic data are collected at baseline; baseline and follow-up questionnaires both gather data on attitudes and perceptions, discrimination, HIV/STI testing history, sexual behaviour, condom use, and pre- and post-exposure prophylaxis. Descriptive, exploratory and multivariate analyses will be performed to address the main research objectives of this study, using appropriate statistical tests and models. These analyses will be performed on the whole cohort data and stratified by study site or country. The study was approved by the Public Health authorities of each country where the study is being implemented. Findings from the COBA-Cohort study will be summarised in a report to the European Commission, and in leaflets to be distributed to study participants. Articles and conference abstracts will be submitted to peer-reviewed journals and conferences. 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/

Prognostic value of quantitative sensory testing in low back pain: a systematic review of the literature

PubMed Central

Marcuzzi, Anna; Dean, Catherine M; Wrigley, Paul J; Chakiath, Rosemary J; Hush, Julia M

2016-01-01

Quantitative sensory testing (QST) measures have recently been shown to predict outcomes in various musculoskeletal and pain conditions. The aim of this systematic review was to summarize the emerging body of evidence investigating the prognostic value of QST measures in people with low back pain (LBP). The protocol for this review was prospectively registered on the International Prospective Register of Systematic Reviews. An electronic search of six databases was conducted from inception to October 2015. Experts in the field were contacted to retrieve additional unpublished data. Studies were included if they were prospective longitudinal in design, assessed at least one QST measure in people with LBP, assessed LBP status at follow-up, and reported the association of QST data with LBP status at follow-up. Statistical pooling of results was not possible due to heterogeneity between studies. Of 6,408 references screened after duplicates removed, three studies were finally included. None of them reported a significant association between the QST measures assessed and the LBP outcome. Three areas at high risk of bias were identified which potentially compromise the validity of these results. Due to the paucity of available studies and the methodological shortcomings identified, it remains unknown whether QST measures are predictive of outcome in LBP. PMID:27660486

Prognostic value of quantitative sensory testing in low back pain: a systematic review of the literature.

PubMed

Marcuzzi, Anna; Dean, Catherine M; Wrigley, Paul J; Chakiath, Rosemary J; Hush, Julia M

2016-01-01

Quantitative sensory testing (QST) measures have recently been shown to predict outcomes in various musculoskeletal and pain conditions. The aim of this systematic review was to summarize the emerging body of evidence investigating the prognostic value of QST measures in people with low back pain (LBP). The protocol for this review was prospectively registered on the International Prospective Register of Systematic Reviews. An electronic search of six databases was conducted from inception to October 2015. Experts in the field were contacted to retrieve additional unpublished data. Studies were included if they were prospective longitudinal in design, assessed at least one QST measure in people with LBP, assessed LBP status at follow-up, and reported the association of QST data with LBP status at follow-up. Statistical pooling of results was not possible due to heterogeneity between studies. Of 6,408 references screened after duplicates removed, three studies were finally included. None of them reported a significant association between the QST measures assessed and the LBP outcome. Three areas at high risk of bias were identified which potentially compromise the validity of these results. Due to the paucity of available studies and the methodological shortcomings identified, it remains unknown whether QST measures are predictive of outcome in LBP.

The EMBARC European Bronchiectasis Registry: protocol for an international observational study

PubMed Central

Aliberti, Stefano; Polverino, Eva; Vendrell, Montserrat; Crichton, Megan; Loebinger, Michael; Dimakou, Katerina; Clifton, Ian; van der Eerden, Menno; Rohde, Gernot; Murris-Espin, Marlene; Masefield, Sarah; Gerada, Eleanor; Shteinberg, Michal; Ringshausen, Felix; Haworth, Charles; Boersma, Wim; Rademacher, Jessica; Hill, Adam T.; Aksamit, Timothy; O'Donnell, Anne; Morgan, Lucy; Milenkovic, Branislava; Tramma, Leandro; Neves, Joao; Menendez, Rosario; Paggiaro, Perluigi; Botnaru, Victor; Skrgat, Sabina; Wilson, Robert; Goeminne, Pieter; De Soyza, Anthony; Welte, Tobias; Torres, Antoni; Elborn, J. Stuart; Blasi, Francesco

2016-01-01

Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1) a clinical history consistent with bronchiectasis; and 2) computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1) bronchiectasis due to known cystic fibrosis; 2) age <18 years; and 3) patients who are unable or unwilling to provide informed consent. The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications. The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials. PMID:27730179

Role of ART in Imprinting Disorders

PubMed Central

Eroglu, Ali; Layman, Lawrence C.

2013-01-01

Assisted reproductive technologies (ART) offer revolutionary infertility treatments for millions of childless couples around the world. Currently, ART accounts for 1 to 3% of annual births in industrialized countries and continues to expand rapidly. Except for an increased incidence of premature births, these technologies are considered safe. However, new evidence published during the past decade has suggested an increased incidence of imprinting disorders in children conceived by ART. Specifically, an increased risk was reported for Beckwith-Wiedemann syndrome (BWS), Angelman syndrome (AS), Silver-Russell syndrome, and retinoblastoma. In contrast, some studies have found no association between ART and BWS, AS, Prader-Willi syndrome, transient neonatal diabetes mellitus, and retinoblastoma. The variability in ART protocols and the rarity of imprinting disorders complicate determining the causative relationship between ART and an increased incidence of imprinting disorders. Nevertheless, compelling experimental data from animal studies also suggest a link between increased imprinting disorders and ART. Further comprehensive, appropriately powered studies are needed to better address the magnitude of the risk for ART-associated imprinting disorders. Large longitudinal studies are particularly critical to evaluate long-term effects of ART not only during the perinatal period but also into adulthood. An important consideration is to determine if the implicated association between ART and imprinting disorders is actually related to the procedures or to infertility itself. PMID:22549709

Using Longitudinal Assessment Data to Improve Retention and Student Experiences

ERIC Educational Resources Information Center

Trosset, Carol; Weisler, Steven

2010-01-01

The Wabash National Study of Liberal Arts Education presents a longitudinal analysis of how students change on a number of scales that purport to measure many of the outcomes of liberal learning over the span of a college education. The Wabash Study is designed to collect information longitudinally from students at the beginning and end of their…

Predicting Family Poverty and Other Disadvantaged Conditions for Child Rearing from Childhood Aggression and Social Withdrawal: A 30-Year Longitudinal Study

ERIC Educational Resources Information Center

Serbin, Lisa A.; Temcheff, Caroline E.; Cooperman, Jessica M.; Stack, Dale M.; Ledingham, Jane; Schwartzman, Alex E.

2011-01-01

This 30-year longitudinal study examined pathways from problematic childhood behavior patterns to future disadvantaged conditions for family environment and child rearing in adulthood. Participants were mothers (n = 328) and fathers (n = 222) with lower income backgrounds participating in the ongoing Concordia Longitudinal Risk Project. Structural…

Longitudinal Pathways between Maternal Mental Health in Infancy and Offspring Romantic Relationships in Adulthood: A 30-Year Prospective Study

ERIC Educational Resources Information Center

Slominski, Lisa; Sameroff, Arnold; Rosenblum, Katherine; Kasser, Tim

2011-01-01

Longitudinal pathways between maternal mental health in infancy and offspring romantic relationship outcomes in adulthood were examined using a 30-year prospective longitudinal study of 196 mothers and their children. Structural equation modeling revealed that maternal mental health at 30 months was related to offspring relationship status and…

Longitudinal Associations between Observed and Perceived Neighborhood Food Availability and Body Mass Index in a Multiethnic Urban Sample

ERIC Educational Resources Information Center

Zenk, Shannon N.; Mentz, Graciela; Schulz, Amy J.; Johnson-Lawrence, Vicki; Gaines, Causandra R.

2017-01-01

Introduction: Blacks, Hispanics, and women of lower socioeconomic status tend to have a higher risk of obesity. Numerous studies over the past decade examined the role of the neighborhood food environment in body weight. However, few were longitudinal. Purpose: This longitudinal study examined whether multiple measures of neighborhood food…

Longitudinal Effects of Perceived Maternal Approval on Sexual Behaviors of Asian and Pacific Islander (API) Young Adults

ERIC Educational Resources Information Center

Hahm, Hyeouk; Lee, Jieha; Zerden, Lisa; Ozonoff, Al; Amodeo, Maryann; Adkins, Chris

2008-01-01

Data were obtained from the National Longitudinal Study of Adolescent Health to examine the longitudinal association between Asian and Pacific Islander (API) adolescents' perceptions of maternal approval of their sexual activity and contraception use, and four sexual outcomes during young adulthood. The study includes a nationally representative…

Longitudinal Relations between Ethnic/Racial Identity Process and Content: Exploration, Commitment, and Salience among Diverse Adolescents

ERIC Educational Resources Information Center

Wang, Yijie; Douglass, Sara; Yip, Tiffany

2017-01-01

The present study bridges the process and content perspectives of ethnic/racial identity (ERI) by examining the longitudinal links between identity process (i.e., exploration, commitment) and a component of identity content, salience. Data were drawn from a 4-wave longitudinal study of 405 ethnically/racially diverse adolescents (63% female) from…