The Effective Management of Primary Schools in Ekiti State, Nigeria: An Analytical Assessment

ERIC Educational Resources Information Center

Adeyemi, T. O.

2009-01-01

This study investigated the management of education in primary schools in Ekiti State, Nigeria. As a correlational research, the study population comprised all the 694 primary schools in the State. Out of this, a sample of 320 schools was selected through the stratified random sampling technique. Two instruments were used to collect data for the…

The dilemma of selecting suitable proximal carious lesions in primary molars for restoration using ART technique.

PubMed

Kemoli, A M; van Amerongen, W E

2011-03-01

To determine the examiner's accuracy in selecting proximal carious lesions in primary molars for restoration using the atraumatic restorative treatment (ART) approach. Intervention study. CLINICAL SETTING AND PARTICIPANTS: A total of 804 six to eight year-olds from 30 rural schools in Kenya participated in the study. Three examiners selected a total of 1,280 suitable proximal carious lesions in primary molars after examining 6,002 children from 30 schools randomly selected out of 142 schools in two divisions. Seven operators randomly paired on a daily basis with eight assistants restored the lesions. An explanation was provided for any cavity that was not restored. Pre-and post-operative radiographs of the cavities were also taken for evaluation. The examiner's choice of suitable proximal cavities restorable using the ART approach was related to the decision made to either restore or not during the operative stage. The radiographic findings of the selected cavities were also compared to the decision made by the operator. The results obtained were used to determine the examiner's accuracy in selecting suitable proximal cavities for restoration using the ART approach. The majority of the children recruited in the study were excluded due to absenteeism, pulpal-exposure or anxiety during the operative stage. Only 804 children received one restoration in their primary molars. The examiner's accuracy in selecting suitable ART-restorable cavities clinically was 94.9% and based on radiographic analysis was 91.7%. A trained and diligent examiner has a very good chance of selecting proximal carious lesions restorable with the use of ART approach, without the threat of dental pulpal-involvement during the excavation of caries.

What affects response rates in primary healthcare-based programmes? An analysis of individual and unit-related factors associated with increased odds of non-response based on HCV screening in the general population in Poland

PubMed Central

Parda, Natalia; Stępień, Małgorzata; Zakrzewska, Karolina; Madaliński, Kazimierz; Kołakowska, Agnieszka; Godzik, Paulina; Rosińska, Magdalena

2016-01-01

Objectives Response rate in public health programmes may be a limiting factor. It is important to first consider their delivery and acceptability for the target. This study aimed at determining individual and unit-related factors associated with increased odds of non-response based on hepatitis C virus screening in primary healthcare. Design Primary healthcare units (PHCUs) were extracted from the Register of Health Care Centres. Each of the PHCUs was to enrol adult patients selected on a random basis. Data on the recruitment of PHCUs and patients were analysed. Multilevel modelling was applied to investigate individual and unit-related factors associated with non-response. Multilevel logistic model was developed with fixed effects and only a random intercept for the unit. Preliminary analysis included a random effect for unit and each of the individual or PHCU covariates separately. For each of the PHCU covariates, we applied a two-level model with individual covariates, unit random effect and a single fixed effect of this unit covariate. Setting This study was conducted in primary care units in selected provinces in Poland. Participants A total of 242 PHCUs and 24 480 adults were invited. Of them, 44 PHCUs and 20 939 patients agreed to participate. Both PHCUs and patients were randomly selected. Results Data on 44 PHCUs and 24 480 patients were analysed. PHCU-level factors and recruitment strategies were important predictors of non-response. Unit random effect was significant in all models. Larger and private units reported higher non-response rates, while for those with a history of running public health programmes the odds of non-response was lower. Proactive recruitment, more working hours devoted to the project and patient resulted in higher acceptance of the project. Higher number of personnel had no such effect. Conclusions Prior to the implementation of public health programme, several factors that could hinder its execution should be addressed. PMID:27927665

What affects response rates in primary healthcare-based programmes? An analysis of individual and unit-related factors associated with increased odds of non-response based on HCV screening in the general population in Poland.

PubMed

Parda, Natalia; Stępień, Małgorzata; Zakrzewska, Karolina; Madaliński, Kazimierz; Kołakowska, Agnieszka; Godzik, Paulina; Rosińska, Magdalena

2016-12-07

Response rate in public health programmes may be a limiting factor. It is important to first consider their delivery and acceptability for the target. This study aimed at determining individual and unit-related factors associated with increased odds of non-response based on hepatitis C virus screening in primary healthcare. Primary healthcare units (PHCUs) were extracted from the Register of Health Care Centres. Each of the PHCUs was to enrol adult patients selected on a random basis. Data on the recruitment of PHCUs and patients were analysed. Multilevel modelling was applied to investigate individual and unit-related factors associated with non-response. Multilevel logistic model was developed with fixed effects and only a random intercept for the unit. Preliminary analysis included a random effect for unit and each of the individual or PHCU covariates separately. For each of the PHCU covariates, we applied a two-level model with individual covariates, unit random effect and a single fixed effect of this unit covariate. This study was conducted in primary care units in selected provinces in Poland. A total of 242 PHCUs and 24 480 adults were invited. Of them, 44 PHCUs and 20 939 patients agreed to participate. Both PHCUs and patients were randomly selected. Data on 44 PHCUs and 24 480 patients were analysed. PHCU-level factors and recruitment strategies were important predictors of non-response. Unit random effect was significant in all models. Larger and private units reported higher non-response rates, while for those with a history of running public health programmes the odds of non-response was lower. Proactive recruitment, more working hours devoted to the project and patient resulted in higher acceptance of the project. Higher number of personnel had no such effect. Prior to the implementation of public health programme, several factors that could hinder its execution should be addressed. 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/.

A Randomized Effectiveness Trial of Brief Cognitive-Behavioral Therapy for Depressed Adolescents Receiving Antidepressant Medication

ERIC Educational Resources Information Center

Clarke, Gregory; DeBar, Lynn; Lynch, Frances; Powell, James; Gale, John; O'Connor, Elizabeth; Ludman, Evette; Bush, Terry; Lin, Elizabeth H. B.; Von Korff, Michael; Hertert, Stephanie

2005-01-01

Objective: To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. Method: A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the…

Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).

PubMed

González-González, Ana Isabel; Orrego, Carola; Perestelo-Perez, Lilisbeth; Bermejo-Caja, Carlos Jesús; Mora, Nuria; Koatz, Débora; Ballester, Marta; Del Pino, Tasmania; Pérez-Ramos, Jeannet; Toledo-Chavarri, Ana; Robles, Noemí; Pérez-Rivas, Francisco Javier; Ramírez-Puerta, Ana Belén; Canellas-Criado, Yolanda; Del Rey-Granado, Yolanda; Muñoz-Balsa, Marcos José; Becerril-Rojas, Beatriz; Rodríguez-Morales, David; Sánchez-Perruca, Luis; Vázquez, José Ramón; Aguirre, Armando

2017-10-30

Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases. This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice. This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases. ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

Scientific Reasoning and Its Relationship with Problem Solving: The Case of Upper Primary Science Teachers

ERIC Educational Resources Information Center

Alshamali, Mahmoud A.; Daher, Wajeeh M.

2016-01-01

This study aimed at identifying the levels of scientific reasoning of upper primary stage (grades 4-7) science teachers based on their use of a problem-solving strategy. The study sample (N = 138; 32 % male and 68 % female) was randomly selected using stratified sampling from an original population of 437 upper primary school teachers. The…

Effect of Emotional Intelligence and Gender on Job Satisfaction of Primary School Teachers

ERIC Educational Resources Information Center

Singh, Bhagat; Kumar, Arun

2016-01-01

The objective of the study was to find out the effect of EI and gender on job satisfaction of primary school teachers. A total of 300 (150 male and 150 female) primary school teachers were selected randomly for the study. Emotional Intelligence Scale (EIS) and Teachers' Job Satisfaction Scale (TJSS) were used to collect the data. The study found a…

Primordial and primary prevention programs for cardiovascular diseases: from risk assessment through risk communication to risk reduction. A review of the literature

PubMed Central

Lancarotte, Inês; Nobre, Moacyr Roberto

2016-01-01

The aim of this study was to identify and reflect on the methods employed by studies focusing on intervention programs for the primordial and primary prevention of cardiovascular diseases. The PubMed, EMBASE, SciVerse Hub-Scopus, and Cochrane Library electronic databases were searched using the terms ‘effectiveness AND primary prevention AND risk factors AND cardiovascular diseases’ for systematic reviews, meta-analyses, randomized clinical trials, and controlled clinical trials in the English language. A descriptive analysis of the employed strategies, theories, frameworks, applied activities, and measurement of the variables was conducted. Nineteen primary studies were analyzed. Heterogeneity was observed in the outcome evaluations, not only in the selected domains but also in the indicators used to measure the variables. There was also a predominance of repeated cross-sectional survey design, differences in community settings, and variability related to the randomization unit when randomization was implemented as part of the sample selection criteria; furthermore, particularities related to measures, limitations, and confounding factors were observed. The employed strategies, including their advantages and limitations, and the employed theories and frameworks are discussed, and risk communication, as the key element of the interventions, is emphasized. A methodological process of selecting and presenting the information to be communicated is recommended, and a systematic theoretical perspective to guide the communication of information is advised. The risk assessment concept, its essential elements, and the relevant role of risk perception are highlighted. It is fundamental for communication that statements targeting other people’s understanding be prepared using systematic data. PMID:27982169

Physical Education in Primary Schools: Classroom Teachers' Perceptions of Benefits and Outcomes

ERIC Educational Resources Information Center

Morgan, Philip J.; Hansen, Vibeke

2008-01-01

Objective: The aim of the current study was to examine the perceptions of classroom teachers regarding the benefits and outcomes of their PE programs. Design: Cross-sectional. Setting: Thirty eight randomly selected primary schools in New South Wales (NSW), Australia. Method: A mixed-mode methodology was utilized, incorporating semi-structured…

Primary Care Physicians' Dementia Care Practices: Evidence of Geographic Variation

ERIC Educational Resources Information Center

Fortinsky, Richard H.; Zlateva, Ianita; Delaney, Colleen; Kleppinger, Alison

2010-01-01

Purpose: This article explores primary care physicians' (PCPs) self-reported approaches and barriers to management of patients with dementia, with a focus on comparisons in dementia care practices between PCPs in 2 states. Design and Methods: In this cross-sectional study, questionnaires were mailed to 600 randomly selected licensed PCPs in…

Effect of Training in Math Metacognitive Strategy on Fractional Achievement of Nigerian Schoolchildren

ERIC Educational Resources Information Center

Onu, V. C.; Eskay, M.; Igbo, J. N.; Obiyo, N.; Agbo, O.

2012-01-01

This study examined the effect of training in math metacognition on fractional mathematics among primary school pupils, with a quasi-experimental design, specifically a post-test only control group design. Two intact classes were randomly selected and assigned to treatment and control conditions. Sixty primary six pupils constituted the sample…

Transtheoretical Model-Based Dietary Interventions in Primary Care: A Review of the Evidence in Diabetes

ERIC Educational Resources Information Center

Salmela, Sanna; Poskiparta, Marita; Kasila, Kirsti; Vahasarja, Kati; Vanhala, Mauno

2009-01-01

The objective of this study was to review the evidence concerning stage-based dietary interventions in primary care among persons with diabetes or an elevated diabetes risk. Search strategies were electronic databases and manual search. Selection criteria were randomized controlled studies with stage-based dietary intervention, conducted in…

Georgia's Pre-K Professional Development Evaluation: Technical Appendix. Publication #2015-02B

ERIC Educational Resources Information Center

Early, Diane M.; Pan, Yi; Maxwell, Kelly L.

2014-01-01

The primary purpose of the accompanying final study was to evaluate the impact of two professional development models on teacher-child interactions in Georgia's Pre-K classrooms. Teachers were randomly selected to participate and were randomly assigned to one of the professional development conditions or to a control group. Because of this…

Many Children Left Behind? Textbooks and Test Scores in Kenya. NBER Working Paper No. 13300

ERIC Educational Resources Information Center

Glewwe, Paul; Kremer, Michael; Moulin, Sylvie

2007-01-01

A randomized evaluation suggests that a program which provided official textbooks to randomly selected rural Kenyan primary schools did not increase test scores for the average student. In contrast, the previous literature suggests that textbook provision has a large impact on test scores. Disaggregating the results by students' initial academic…

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chen, Minghao; Wei, Shiyou; Hu, Junyan; Yuan, Jing; Liu, Fenghua

2017-01-01

The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94-1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06-1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80-1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use.

Comparison of Cardiovascular Risk Screening Methods and Mortality Data among Hungarian Primary Care Population: Preliminary Results of the First Government-Financed Managed Care Program.

PubMed

Móczár, Csaba; Rurik, Imre

2015-09-01

Besides participation in the primary prevention, screening as secondary prevention is an important requirement for primary care services. The effect of this work is influenced by the characteristics of individual primary care practices and doctors' screening habits, as well as by the regulation of screening processes and available financial resources. Between 1999 and 2009, a managed care program was introduced and carried out in Hungary, financed by the government. This financial support and motivation gave the opportunity to increase the number of screenings. 4,462 patients of 40 primary care practices were screened on the basis of SCORE risk assessment. The results of the screening were compared on the basis of two groups of patients, namely: those who had been pre-screened (pre-screening method) for known risk factors in their medical history (smoking, BMI, age, family cardiovascular history), and those randomly screened. The authors also compared the mortality data of participating primary care practices with the regional and national data. The average score was significantly higher in the pre-screened group of patients, regardless of whether the risk factors were considered one by one or in combination. Mortality was significantly lower in the participating primary practices than had been expected on the basis of the national mortality data. This government-financed program was a big step forward to establish a proper screening method within Hungarian primary care. Performing cardiovascular screening of a selected target group is presumably more appropriate than screening within a randomly selected population. Both methods resulted in a visible improvement in regional mortality data, though it is very likely that with pre-screening a more cost-effective selection for screening may be obtained.

Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

PubMed

Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

2017-10-01

Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to a large extent, to selective outcome reporting. Readers should be aware of this to avoid implementation of false or misleading results in clinical practice. No funding received and there are no conflicts of interest. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Prevalence and Pattern of Learning Difficulties in Primary School Students in Jordan

ERIC Educational Resources Information Center

Abu-Hamour, Bashir; Al-Hmouz, Hanan

2016-01-01

The major purpose of this study was to investigate the prevalence of learning difficulties (LDs) among primary school students (Grade 1 to Grade 3) in Jordan. A total of 306 students were randomly selected and tested using the Arabic version of the Woodcock-Johnson Basic Achievement Tests that measure reading, spelling, and calculation skills. The…

The Relationship between Happiness, Subjective Well-Being, Creativity and Job Performance of Primary School Teachers in Ramhormoz City

ERIC Educational Resources Information Center

Jalali, Zohreh; Heidari, Alireza

2016-01-01

The research aimed to investigate the relationship between happiness, subjective well-being, creativity and job performance of primary school teachers in Ramhormoz City. Hence, a sample of 330 individuals was selected through random stratified sampling. The research tools included Oxford Happiness Inventory, Subjective Well-being Scale by Keyes…

Miscue Analysis of Oral Reading among Less Proficient Readers in Primary Schools in Brunei Darussalam

ERIC Educational Resources Information Center

Hamid, Juliana Bte Haji Abdul; Abosi, Okechukwu

2011-01-01

Reading disability is the most common disability. At least one in five children has significant challenges learning to read. This study focused on the oral reading performance of 30 Year-Three students. The students were identified as less proficient readers from two randomly selected primary schools in Brunei Darussalam. The oral reading…

Acceptability of Adaptations for Struggling Writers: A National Survey with Primary-Grade Teachers

ERIC Educational Resources Information Center

Graham, Steve; Harris, Karen R.; Bartlett, Brendan J.; Popadopoulou, Eleni; Santoro, Julia

2016-01-01

One hundred twenty-five primary-grade teachers randomly selected from across the United States indicated how frequently they made 20 instructional adaptations for the struggling writers in their classroom. The measure of frequency ranged from never, several times a year, monthly, weekly, several times a week, and daily. Using a 6-point Likert-type…

Effectiveness of Supervisions Conducted by Primary Education Supervisors According to School Principals' Evaluations

ERIC Educational Resources Information Center

Yavuz, Mustafa

2010-01-01

The author conducted a qualitative case study. The population of the study consisted of 8 randomly selected school principals in the area of primary education supervisors working in Konya, a province of the Turkish Republic. Face-to-face and semistructured interviews were held with the school principals within the population for 90 min. The…

Cluster Supervision Practices in Primary School of Jimma Zone

ERIC Educational Resources Information Center

Afework, E. A.; Frew, A. T.; Abeya, G. G.

2017-01-01

The main objective of this study was to assess the supervisory practice of cluster resource centre (CRC) supervisors in Jimma Zone primary schools. To achieve this purpose, the descriptive survey design was employed. Data were collected from 238 randomly selected teachers, and 60 school principals with a response rate of 98.6%. Moreover, 12 CRC…

A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol

PubMed Central

Kangovi, Shreya; Mitra, Nandita; Turr, Lindsey; Huo, Hairong; Grande, David; Long, Judith A.

2017-01-01

Upstream interventions – e.g. housing programs and community health worker interventions-address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of an upstream intervention in a sample of patients with different diseases? This paper addresses this question using an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus community health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and tobacco dependence. At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus on during the study, and to collaboratively set a goal for that disease. Patients randomly assigned to a community health worker also received six months of support to address socioeconomic and behavioral barriers to chronic disease control. The primary hypothesis was that there would be differences in patients’ selected chronic disease control as measured by HbA1c, body mass index, systolic blood pressure and cigarettes per day, between the goal-setting alone and community health worker support arms. To test this hypothesis, we will conduct a stratum specific multivariate analysis of variance which allows all patients (regardless of their selected chronic disease) to be included in a single model for the primary outcome. Population health researchers can use this approach to measure clinical outcomes across diseases. PMID:27965180

Quantification of diabetes consultations by the main primary health care nurse groups in Auckland, New Zealand.

PubMed

Daly, Barbara; Arroll, Bruce; Sheridan, Nicolette; Kenealy, Timothy; Scragg, Robert

2016-09-01

Diabetes prevalence continues to increase, with most diabetes patients managed in primary care. This report quantifies the number of diabetes consultations undertaken by primary healthcare nurses in Auckland, New Zealand. Of 335 primary healthcare nurses randomly selected, 287 (86%) completed a telephone interview in 2006-2008. On a randomly sampled day (from the past seven) for each nurse, 42% of the nurses surveyed (n=120) consulted 308 diabetes patients. From the proportion of nurses sampled in the study, it is calculated that the number of diabetes patients consulted by primary healthcare nurses per week in Auckland between September 2006 and February 2008 was 4210, with 61% consulted by practice, 23% by specialist and 16% by district nurses. These findings show that practice nurses carry out the largest number of community diabetes consultations by nurses. Their major contribution needs to be incorporated into future planning of the community management of diabetes.

Modeling of Academic Achievement of Primary School Students in Ethiopia Using Bayesian Multilevel Approach

ERIC Educational Resources Information Center

Sebro, Negusse Yohannes; Goshu, Ayele Taye

2017-01-01

This study aims to explore Bayesian multilevel modeling to investigate variations of average academic achievement of grade eight school students. A sample of 636 students is randomly selected from 26 private and government schools by a two-stage stratified sampling design. Bayesian method is used to estimate the fixed and random effects. Input and…

Frequent users of rural primary care: comparisons with randomly selected users.

PubMed

Mehl-Madrona, L E

1998-01-01

Frequent users of primary care have not been adequately characterized. The unique characteristics of this population was sought--why they come so often, what their care costs, and whether psychosocial factors play a role in their high utilization of health care. The billing system of a rural primary care clinic was used to find the frequency of visits for all patients attending the clinic for the previous 12 months. The 211 most frequent visitors were selected. A comparison group of 250 patients was drawn from the billing records using a random number generator. Charts were reviewed to compare diagnoses (by frequency), number of procedures, amount billed for care, amount received from those billings, number of psychotropic medications prescribed, and response to medication. A subgroup of each group was interviewed to confirm chart review findings and to inquire about personal reasons for coming to the clinic. Compared with patients who were random users, patients who were frequent users were more likely to come from the younger and older age groups, they averaged significantly more emergency department visits and visits to other specialists (P < 0.0001), and they had more mental health problems diagnosed (P < 0.01). Significantly more frequent users were insured by Medicaid and fewer were insured by Medicare. They had more detailed office visits and more laboratory tests. They received twice as much psychotherapy and had a higher percentage of problem-focused office visits. Chart audits and interviews of selected patients revealed that many nonmedical reasons were related to visits in addition to psychosocial stressors. Nonmedical factors are important among the most frequent users of a primary care clinic. Proposals to improve care for frequent users should consider the psychosocial needs of this population.

Performance of Universal Adhesive in Primary Molars After Selective Removal of Carious Tissue: An 18-Month Randomized Clinical Trial.

PubMed

Lenzi, Tathiane Larissa; Pires, Carine Weber; Soares, Fabio Zovico Maxnuck; Raggio, Daniela Prócida; Ardenghi, Thiago Machado; de Oliveira Rocha, Rachel

2017-09-15

To evaluate the 18-month clinical performance of a universal adhesive, applied under different adhesion strategies, after selective carious tissue removal in primary molars. Forty-four subjects (five to 10 years old) contributed with 90 primary molars presenting moderately deep dentin carious lesions on occlusal or occluso-proximal surfaces, which were randomly assigned following either self-etch or etch-and-rinse protocol of Scotchbond Universal Adhesive (3M ESPE). Resin composite was incrementally inserted for all restorations. Restorations were evaluated at one, six, 12, and 18 months using the modified United States Public Health Service criteria. Survival estimates for restorations' longevity were evaluated using the Kaplan-Meier method. Multivariate Cox regression analysis with shared frailty to assess the factors associated with failures (P<0.05). Estimated survival rates of the restorations were 100 percent, 100 percent, 90.6 percent, and 81.4 percent at one, six, 12, and 18 months, respectively. The adhesion strategy did not influence the restorations' longevity (P=0.06; 72.2 percent and 89.7 percent with etch-and-rinse and self-etch mode, respectively). Self-etch and etch-and-rinse strategies did not influence the clinical behavior of universal adhesive used in primary molars after selective carious tissue removal; although there was a tendency for better outcome of the self-etch strategy.

The Effect of Children's Rights Training on Primary School Students' Utilisation and Knowledge Level about Children's Rights

ERIC Educational Resources Information Center

Ozmen, Suna Kaymak; Ocal, Tugba; Ozmen, Ahmet

2014-01-01

Recently, children's rights issue has taken attention. In this study, main purpose was to investigate the utilisation and knowledge level of 4th and 5th grade primary school students after children's rights training. The participants of this survey study were selected randomly from 10 schools. Results indicated that students had the chance to…

Teachers' Opinions on the Incorporation of Environmental Education in the Nigerian Primary School Curriculum

ERIC Educational Resources Information Center

Jekayinfa, Alice Arinlade; Yusuf, Abdul Raheem

2008-01-01

This paper presents the report of a research carried out in Kwara Sate of Nigeria to seek the opinions of teachers on the incorporation of Environmental Education (EE) in the Nigerian Primary School Curriculum. The descriptive survey method was employed for the study. 200 teachers were selected through stratified random sampling technique to cater…

Factors Influencing Teachers' Competence in Developing Resilience in Vulnerable Children in Primary Schools in Uasin Gishu County, Kenya

ERIC Educational Resources Information Center

Silyvier, Tsindoli; Nyandusi, Charles

2015-01-01

The purpose of the study was to assess the effect of teacher characteristics on their competence in developing resilience in vulnerable primary school children. A descriptive survey research design was used. This study was based on resiliency theory as proposed by Krovetz (1998). Simple random sampling was used to select a sample size of 108…

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials

PubMed Central

Yuan, Jing; Liu, Fenghua

2017-01-01

Objective The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Methods Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Results Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94–1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06–1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80–1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Conclusions Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use. PMID:28570713

The Effectiveness of Conflict Maps and the V-Shape Teaching Method in Science Conceptual Change among Eighth-Grade Students in Jordan

ERIC Educational Resources Information Center

Bawaneh, Ali Khalid Ali; Zain, Ahmad Nurulazam Md; Ghazali, Munirah

2010-01-01

The purpose of the present study is to investigate the effectiveness of Conflict Maps and the V-Shape method as teaching methods in bringing about conceptual change in science among primary eighth-grade students in Jordan. A randomly selected sample (N = 63) from the Bani Kenana region North of Jordan was randomly assigned to the two teaching…

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

PubMed Central

Scott, Jared T.; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Background Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. Methods We searched PubMed for randomized controlled trials from Jan 1, 2010 –Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. Results 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Conclusion Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes. PMID:28727834

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals.

PubMed

Howard, Benjamin; Scott, Jared T; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. We searched PubMed for randomized controlled trials from Jan 1, 2010 -Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes.

Investigation of the Effectiveness of Teacher-Education Curriculum in Primary School Mathematics in Tanzania Mainland. African Studies in Curriculum Development & Evaluation. No. 64.

ERIC Educational Resources Information Center

Masota, Laurent Anatoly

An investigation was made of the effectiveness of the teacher education curriculum for primary school mathematics teachers in Tanzania. Subjects were a random sample of 8 teacher trainees in each of 4 selected colleges, as well as 4 school principals, 12 tutors, and 16 serving teachers. Data were gathered by means of questionnaires and…

Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial.

PubMed

Kloeckner, Roman; Ruckes, Christian; Kronfeld, Kai; Wörns, Marcus Alexander; Weinmann, Arndt; Galle, Peter Robert; Lang, Hauke; Otto, Gerd; Eichhorn, Waltraud; Schreckenberger, Mathias; Dueber, Christoph; Pitton, Michael Bernhard

2014-08-06

Cholangiocellular carcinoma is the second most common primary liver cancer after hepatocellular carcinoma. Over the last 30 years, the incidence of intrahepatic cholangiocellular carcinoma has risen continuously worldwide. Meanwhile, the intrahepatic cholangiocellular carcinoma has become more common than the extrahepatic growth type and currently accounts for 10-15% of all primary hepatic malignancies. Intrahepatic cholangiocellular carcinoma is typically diagnosed in advanced stages due to late clinical symptoms and an absence of classic risk factors. A late diagnosis precludes curative surgical resection. There is evidence that transarterial chemoembolization leads to better local tumor control and prolongs survival compared to systemic chemotherapy. New data indicates that selective internal radiotherapy, also referred to as radioembolization, provides promising results for treating intrahepatic cholangiocellular carcinoma. This pilot study is a randomized, controlled, single center, phase II trial. Twenty-four patients with intrahepatic cholangiocellular carcinoma will be randomized in a 1:1 ratio to receive either chemoembolization or radioembolization. Randomization will be stratified according to tumor load. Progression-free survival is the primary endpoint; overall survival and time to progression are secondary endpoints. To evaluate treatment success, patients will receive contrast enhanced magnetic resonance imaging every 3 months. Currently, chemoembolization is routinely performed in many centers instead of systemic chemotherapy for treating intrahepatic cholangiocellular carcinoma confined to the liver. Recently, radioembolization has been increasingly applied to cholangiocellular carcinoma as second line therapy after TACE failure or even as an alternative first line therapy. Nonetheless, no randomized studies have compared radioembolization and chemoembolization. Considering all this background information, we recognized a strong need for a randomized controlled trial (RCT) to compare the two treatments. Therefore, the present protocol describes the design of a RCT that compares SIRT and TACE as the first line therapy for inoperable CCC confined to the liver. ClinicalTrials.gov, Identifier: NCT01798147, registered 16th of February 2013.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial

PubMed Central

2013-01-01

Background To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Methods/design Experimental study. Randomized clinical trial. Follow-up period: one year. Study setting: primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. Intervention components: a) Organizational intervention on the patient/professional relationship. Centered on the Chronic Care Model, the Stanford Expert Patient Program and the Kaiser Permanente model: Teamwork, informed and active patient, decision making shared with the patient, recommendations based on clinical guidelines, single electronic medical history per patient that allows the use of indicators for risk monitoring and stratification. b) Formative strategy for professionals: 4 face-to-face training workshops (one every 3 months), monthly update clinical sessions, online tutorial by a cardiologist, availability through the intranet of the action protocol and related documents. Measurements: Blood pressure, blood glucose, HbA1c, lipid profile and smoking. Frequent health care visits. Number of hospitalizations related to vascular disease. Therapeutic compliance. Drug use. Discussion This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. Trial registration NCT01826929 PMID:23915267

Reweighting of the primary sampling units in the National Automotive Sampling System

DOT National Transportation Integrated Search

1997-09-01

The original design of hte National Automotive Sampling System - formerly the National Accident Sampling System - called for 75 PSUs randomly selected from PSUs which were grouped into various strata across the U.S. The implementation of the PSU samp...

Studying the Effectiveness of Combination Therapy (Based on Executive Function and Sensory Integration) Child-Centered on the Symptoms of Attention Deficit/hyperactivity Disorder (ADHD)

ERIC Educational Resources Information Center

Salami, Fatemeh; Ashayeri, Hassan; Estaki, Mahnaz; Farzad, Valiollah; Entezar, Roya Koochak

2017-01-01

The aim of the present study is to examine the effectiveness of combination therapy based on executive function and sensory integration child-centered on ADHD. For this purpose, from among all first, second and third grade primary school students in Shiraz, 40 children were selected. The selected students were randomly assigned in two groups of…

Laparoscopy to Predict the Result of Primary Cytoreductive Surgery in Patients With Advanced Ovarian Cancer: A Randomized Controlled Trial.

PubMed

Rutten, Marianne J; van Meurs, Hannah S; van de Vrie, Roelien; Gaarenstroom, Katja N; Naaktgeboren, Christiana A; van Gorp, Toon; Ter Brugge, Henk G; Hofhuis, Ward; Schreuder, Henk W R; Arts, Henriette J G; Zusterzeel, Petra L M; Pijnenborg, Johanna M A; van Haaften, Maarten; Fons, Guus; Engelen, Mirjam J A; Boss, Erik A; Vos, M Caroline; Gerestein, Kees G; Schutter, Eltjo M J; Opmeer, Brent C; Spijkerboer, Anje M; Bossuyt, Patrick M M; Mol, Ben Willem; Kenter, Gemma G; Buist, Marrije R

2017-02-20

Purpose To investigate whether initial diagnostic laparoscopy can prevent futile primary cytoreductive surgery (PCS) by identifying patients with advanced-stage ovarian cancer in whom > 1 cm of residual disease will be left after PCS. Patients and Methods This multicenter, randomized controlled trial was undertaken within eight gynecologic cancer centers in the Netherlands. Patients with suspected advanced-stage ovarian cancer who qualified for PCS were eligible. Participating patients were randomly assigned to either laparoscopy or PCS. Laparoscopy was used to guide selection of primary treatment: either primary surgery or neoadjuvant chemotherapy followed by interval surgery. The primary outcome was futile laparotomy, defined as a PCS with residual disease of > 1 cm. Primary analyses were performed according to the intention-to-treat principle. Results Between May 2011 and February 2015, 201 participants were included, of whom 102 were assigned to diagnostic laparoscopy and 99 to primary surgery. In the laparoscopy group, 63 (62%) of 102 patients underwent PCS versus 93 (94%) of 99 patients in the primary surgery group. Futile laparotomy occurred in 10 (10%) of 102 patients in the laparoscopy group versus 39 (39%) of 99 patients in the primary surgery group (relative risk, 0.25; 95% CI, 0.13 to 0.47; P < .001). In the laparoscopy group, three (3%) of 102 patients underwent both primary and interval surgery compared with 28 (28%) of 99 patients in the primary surgery group ( P < .001). Conclusion Diagnostic laparoscopy reduced the number of futile laparotomies in patients with suspected advanced-stage ovarian cancer. In women with a plan for PCS, these data suggest that performance of diagnostic laparoscopy first is reasonable and that if cytoreduction to < 1 cm of residual disease seems feasible, to proceed with PCS.

Double-Blind, Placebo-Controlled, Randomized Phase III Trial Evaluating Pertuzumab Combined With Chemotherapy for Low Tumor Human Epidermal Growth Factor Receptor 3 mRNA-Expressing Platinum-Resistant Ovarian Cancer (PENELOPE).

PubMed

Kurzeder, Christian; Bover, Isabel; Marmé, Frederik; Rau, Joern; Pautier, Patricia; Colombo, Nicoletta; Lorusso, Domenica; Ottevanger, Petronella; Bjurberg, Maria; Marth, Christian; Barretina-Ginesta, Pilar; Vergote, Ignace; Floquet, Anne; Del Campo, Josep M; Mahner, Sven; Bastière-Truchot, Lydie; Martin, Nicolas; Oestergaard, Mikkel Z; Kiermaier, Astrid; Schade-Brittinger, Carmen; Polleis, Sandra; du Bois, Andreas; Gonzalez-Martin, Antonio

2016-07-20

The AGO-OVAR 2.29/ENGOT-ov14/PENELOPE prospectively randomized phase III trial evaluated the addition of pertuzumab to chemotherapy in patients with platinum-resistant ovarian carcinoma with low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression. We report the results of the primary efficacy analysis. Eligible patients had ovarian carcinoma that progressed during or within 6 months of completing four or more platinum cycles, centrally tested low tumor HER3 mRNA expression (concentration ratio ≤ 2.81 by quantitative reverse transcriptase polymerase chain reaction on cobas z480 [Roche Molecular Diagnostics, Pleasanton, CA]), and no more than two prior lines of chemotherapy. After investigators' selection of the chemotherapy backbone (single-agent topotecan, weekly paclitaxel, or gemcitabine), patients were randomly assigned to also receive either placebo or pertuzumab (840-mg loading dose followed by 420 mg every 3 weeks). Stratification factors were selected chemotherapy, prior antiangiogenic therapy, and platinum-free interval. The primary end point was independent review committee-assessed progression-free survival (PFS). Additional end points included overall survival, investigator-assessed PFS, objective response rate, safety, patient-reported outcomes, and translational research. Overall, 156 patients were randomly assigned. Adding pertuzumab to chemotherapy did not significantly improve independent review committee-assessed PFS for the primary analysis (stratified hazard ratio, 0.74; 95% CI, 0.50 to 1.11; P = .14; median PFS, 4.3 months for pertuzumab plus chemotherapy v 2.6 months for placebo plus chemotherapy). Sensitivity analyses and secondary efficacy end point results were consistent with the primary analysis. The effect on PFS favoring pertuzumab was more pronounced in the gemcitabine and paclitaxel cohorts. No new safety signals were seen. Although the primary objective was not met, subgroup analyses showed trends in PFS favoring pertuzumab in the gemcitabine and paclitaxel cohorts, meriting further exploration of pertuzumab in ovarian cancer. © 2016 by American Society of Clinical Oncology.

Provider-related barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs) and hospitals.

PubMed

Bogart, Laura M; Howerton, Devery; Lange, James; Setodji, Claude Messan; Becker, Kirsten; Klein, David J; Asch, Steven M

2010-06-01

We examined provider-reported barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs), and hospitals. 12 primary metropolitan statistical areas (PMSAs; three per region) were sampled randomly, with sampling weights proportional to AIDS case reports. Across PMSAs, all 671 hospitals and a random sample of 738 clinics/CBOs were telephoned for a survey on rapid HIV test availability. Of the 671 hospitals, 172 hospitals were randomly selected for barriers questions, for which 158 laboratory and 136 department staff were eligible and interviewed in 2005. Of the 738 clinics/CBOs, 276 were randomly selected for barriers questions, 206 were reached, and 118 were eligible and interviewed in 2005-2006. In multivariate models, barriers regarding translation of administrative/quality assurance policies into practice were significantly associated with rapid HIV testing availability. For greater rapid testing diffusion, policies are needed to reduce administrative barriers and provide quality assurance training to non-laboratory staff.

Authentic Leadership and Altruism: The Mediating Role of Meaningfulness

ERIC Educational Resources Information Center

Sagnak, Mesut; Kuruöz, Mehmet

2017-01-01

The purpose of this study was to investigate the mediating effects of meaningfulness on the relationship between authentic leadership and altruistic behavior. The participants consisted of 356 teachers randomly selected from 14 primary and secondary schools in Nigde. Three different instruments were used in this study. The scales were translated…

A Developmental Analysis of Certain Piagetian Concepts among Some Nigerian Children.

ERIC Educational Resources Information Center

Ehindero, O. J.

1982-01-01

The concepts of distance, area, and the coordinate reference systems were investigated in relation to the displacement volume task among 300 randomly selected primary and high school children in Nigeria. Although results support Piaget's hypothesis, a developmental lag of about two years was observed in Nigerian students. (JN)

Comparing Help-Seeking Behavior of Male and Female Survivors of Sexual Assault: A Content Analysis of a Hotline.

PubMed

Young, Stephen M; Pruett, Jana A; Colvin, Marianna L

2018-06-01

This content analysis examines written documentation of telephone calls to a regional sexual assault hotline over a 5-year period. All male callers identified as primary victims were selected for analysis ( n = 58) and a corresponding sample of female primary victims ( n = 58) were randomly selected for comparison to better understand the help-seeking behavior of sexual assault survivors and inform services accordingly. A summative content analysis revealed significant contrasting themes between male and female victims, including females significantly receiving more referrals and males accessing the hotline to tell their experience of being sexually assaulted due to perceived limited support. Implications for training, practice, and future research are discussed.

Dissecting partner recognition by an intrinsically disordered protein using descriptive random mutagenesis.

PubMed

Gruet, Antoine; Dosnon, Marion; Vassena, Andrea; Lombard, Vincent; Gerlier, Denis; Bignon, Christophe; Longhi, Sonia

2013-09-23

In view of getting insights into the molecular determinants of the binding efficiency of intrinsically disordered proteins (IDPs), we used random mutagenesis. As a proof of concept, we chose the interaction between the intrinsically disordered C-terminal domain of the measles virus nucleoprotein (NTAIL) and the X domain (XD) of the viral phosphoprotein and assessed how amino acid substitutions introduced at random within NTAIL affect partner recognition. In contrast with directed evolution approaches, we did not apply any selection and used the gene library approach not for production purposes but for achieving a better understanding of the NTAIL/XD interaction. For that reason, and to differentiate our approach from similar approaches that make use of systematic (i.e., targeted) mutagenesis, we propose to call it "descriptive random mutagenesis" (DRM). NTAIL variants generated by error-prone PCR were picked at random in the absence of selection pressure and were characterized in terms of sequence and binding abilities toward XD. DRM not only identified determinants of NTAIL/XD interaction that were in good agreement with previous work but also provided new insights. In particular, we discovered that the primary interaction site is poorly evolvable in terms of binding abilities toward XD. We also identified a critical NTAIL residue whose role in stabilizing the NTAIL/XD complex had previously escaped detection, and we identified NTAIL regulatory sites that dampen the interaction while being located outside the primary interaction site. Results show that DRM is a valuable approach to study binding abilities of IDPs. © 2013 Elsevier Ltd. All rights reserved.

Satisfaction of Patients Attending in Primary Healthcare Centers in Riyadh, Saudi Arabia: A Random Cross-Sectional Study.

PubMed

Almutairi, Khalid M

2017-06-01

This study aims to determine the level of satisfaction of patients who visit primary healthcare centers in Riyadh, Saudi Arabia. The investigation was a cross-sectional study conducted in twenty randomly selected primary healthcare centers in Riyadh, Saudi Arabia from October to December 2014. A descriptive data analysis was performed. Eligible participants had visited at least one of the selected primary healthcare centers within the past 12 months. A total of 1741 participants completed the survey, providing a response rate of 87 % (43 % male, 57 % female). The highest satisfaction rates were in the following areas: comprehensiveness and coordination 76.2 % (95 % CI 74.8 ± 77.5), communication 72.7 % (95 % CI 71.3 ± 74) and attitude of staff 73.4 % (95 % CI 72.1 ± 74.8) The areas of greatest concern expressed by the participants were the length of the wait and the quality of the facility 55.4 % (95 % CI 53.3 ± 57.5), 50.5 % (95 % CI 48.3 ± 52.7), respectively. The majority of the patients attending primary healthcare centers in Riyadh showed high levels of satisfaction; however, there are still some factors that need to be considered and improved upon. These include the accessibility of primary healthcare centers as well as waiting time of patients. The results of the current study showed relative improvement in other factors such as comprehensiveness and coordination, communication and attitude of staff. The level of satisfaction of patients and stakeholders shows the progress of the quality of care in healthcare facilities in Riyadh, Saudi Arabia.

Evaluation of the Effectiveness of a Primary Preventive Dental Health Education Programme Implemented Through School Teachers for Primary School Children in Mysore City

PubMed Central

Naidu, Jaya; Nandlal, B.

2017-01-01

Aims and Objectives: The present study was conducted with the aim of evaluating the effectiveness of a Primary Preventive Dental Health Education Programme conducted for 6–12-year-old primary school children in Mysore City. Materials and Methods: A total of 12 schools, one each in the category of Government, Aided, and Unaided, were randomly selected per zone viz., North, South, East, and West. These 12 schools constituted the study group where the Primary Preventive School Dental Health Education Programme (PPSDHEP) was implemented. Two additional schools were selected at random from the four zones to serve as the control. A total of 926 children participated in the study. The PPSDHEP involved the second-level transfer of preventive package wherein the oral health education was imparted to the school children by schoolteachers trained by the investigator. Among the parameters for evaluating the outcome of the programme were the pre and post-programme assessment (at the baseline and at follow-up, i.e., after 6 months) of knowledge, attitude, and practice (KAP), dental caries status, oral hygiene, and gingival health status. Results: The results suggest that the PPSDHEP resulted in bringing about an enhancement in the KAP towards oral health and also an improvement in dental caries, oral hygiene, and gingival health status of the school children in the study group. Conclusion: The present study supports the implementation of similar programmes in schools and the contention that schoolteachers are suitable personnel for imparting dental health education to school children on a regular basis. PMID:28462175

Shared Genetic Influences on Negative Emotionality and Major Depression/Conduct Disorder Comorbidity

ERIC Educational Resources Information Center

Tackett, Jennifer L.; Waldman, Irwin D.; Van Hulle, Carol A.; Lahey, Benjamin B.

2011-01-01

Objective: To investigate whether genetic contributions to major depressive disorder and conduct disorder comorbidity are shared with genetic influences on negative emotionality. Method: Primary caregivers of 2,022 same- and opposite-sex twin pairs 6 to 18 years of age comprised a population-based sample. Participants were randomly selected across…

An Analysis of Young Children Learning Keyboarding Skills.

ERIC Educational Resources Information Center

Cowles, Milly; And Others

The primary purpose of this study was to demonstrate whether children ages 5 through 8 could learn keyboarding skills. A secondary purpose was to examine the relationship between typing skill development and motor proficiency. A sample of 24 children was randomly selected from a group attending a summer school enrichment program. The…

Barriers to Distance Education in Rural Schools

ERIC Educational Resources Information Center

Irvin, Matthew J.; Hannum, Wallace H.; Varre, Claire de la; Farmer, Thomas W.

2010-01-01

The primary purpose of the current study was to examine barriers to the use of distance education and explore related factors in small and low-income rural schools. Data were collected via a telephone survey with administrators or other qualified personnel. The sample involved 417 randomly selected small and low-income rural school districts…

Approaches to Building Teacher-Parent Cooperation

ERIC Educational Resources Information Center

Cankar, Franc; Deutsch, Tomi; Sentocnik, Sonja

2012-01-01

The purpose of this study was to explore the areas of cooperation in which parent and teacher expectations were the same and where they differed. Data were obtained from a sample of 55 randomly selected primary schools. We analyzed school-to home communications, parental influence on school decisions, and parent involvement in different school…

Development of Effective Teacher Program: Teamwork Building Program for Thailand's Municipal Schools

ERIC Educational Resources Information Center

Chantathai, Pimpka; Tesaputa, Kowat; Somprach, Kanokorn

2015-01-01

This research is aimed to formulate the effective teacher teamwork program in municipal schools in Thailand. Primary survey on current situation and problem was conducted to develop the plan to suggest potential programs. Samples were randomly selected from municipal schools by using multi-stage sampling method in order to investigate their…

Evaluation of Students' Perceptions about Efficiency of Educational Club Practices in Primary Schools

ERIC Educational Resources Information Center

Gelen, Ismail; Onay, Ihsan; Varol, Volkan

2014-01-01

The purpose of this study is to examine the efficiency of "Educational Club Practices" that has been in Elementary School program since 2005-2006, by examining the attitudes of students about "Educational Club Practices". Sample was selected in two steps. First, stratified sampling was employed and then random sampling was…

The Evaluation of Teachers' Job Performance Based on Total Quality Management (TQM)

ERIC Educational Resources Information Center

Shahmohammadi, Nayereh

2017-01-01

This study aimed to evaluate teachers' job performance based on total quality management (TQM) model. This was a descriptive survey study. The target population consisted of all primary school teachers in Karaj (N = 2917). Using Cochran formula and simple random sampling, 340 participants were selected as sample. A total quality management…

The Community Education Coordinator: Sources of Job Satisfaction and Dissatisfaction.

ERIC Educational Resources Information Center

Sheppard, Bunny G.

The determination of those factors of motivation and hygiene which led to job satisfaction/dissatisfaction of forty-five randomly selected community education coordinators in six mid-Atlantic states was the primary purpose of this interview-oriented research study. A second purpose was to examine the relationship between age, gender, marital…

The Effects of Portfolio Assessment on Writing of EFL Students

ERIC Educational Resources Information Center

Nezakatgoo, Behzad

2011-01-01

The primary focus of this study was to determine the effect of portfolio assessment on final examination scores of EFL students' writing skill. To determine the impact of portfolio-based writing assessment 40 university students who enrolled in composition course were initially selected and divided randomly into two experimental and control…

Adolescent Sexuality Related Beliefs and Differences by Sexual Experience Status

ERIC Educational Resources Information Center

Tolma, Eleni L.; Oman, Roy F.; Vesely, Sara K.; Aspy, Cheryl B.; Rodine, Sharon; Marshall, LaDonna; Fluhr, Janene

2007-01-01

Purpose: To examine if attitudes toward premarital sex, beliefs about peer influence, and family communication about sexual relationships differ by sexual experience status. Methods: Data were collected from a randomly selected ethnically diverse youth sample (N = 1,318) residing in two Midwestern cities. The primary method used in data analysis…

Mental Computation: Evidence from Fifth Graders

ERIC Educational Resources Information Center

Erdem, Emrullah

2017-01-01

The current study examines the mental computation performance owned by students at fifth grade. This study was carried out with 118 fifth graders (11-12-year-olds) studying at 3 randomly selected primary schools that served low and middle socio-economic areas in a city of Turkey. "Mental Computation Test (MCT)" has been used to reach how…

The Impact of Property Wealth and Income Wealth on School Bond Elections.

ERIC Educational Resources Information Center

Jacobson, Thomas

1997-01-01

Examines the linkage between facility bond elections and the indicators of wealth (property valuation and income) and the appropriateness of relying on property valuations as the primary indicator of school district wealth. Results from 31 randomly selected schools in Nebraska show an unclear relationship between wealth factors and success in…

Farmers as Consumers of Agricultural Education Services: Willingness to Pay and Spend Time

ERIC Educational Resources Information Center

Charatsari, Chrysanthi; Papadaki-Klavdianou, Afroditi; Michailidis, Anastasios

2011-01-01

This study assessed farmers' willingness to pay for and spend time attending an Agricultural Educational Program (AEP). Primary data on the demographic and socio-economic variables of farmers were collected from 355 farmers selected randomly from Northern Greece. Descriptive statistics and multivariate analysis methods were used in order to meet…

Evidence of selective reporting bias in hematology journals: A systematic review

PubMed Central

Scheckel, Caleb; Hicks, Chandler; Nissen, Timothy; Leduc, Linda; Som, Mousumi; Vassar, Matt

2017-01-01

Introduction Selective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored. Methods Our primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included. Results Of 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes. Conclusion Our results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making. PMID:28570573

Chile: Acceptability of a Training Program for Depression Management in Primary Care.

PubMed

Marín, Rigoberto; Martínez, Pablo; Cornejo, Juan P; Díaz, Berta; Peralta, José; Tala, Álvaro; Rojas, Graciela

2016-01-01

In Chile, there are inconsistencies in the management of depression in primary care settings, and the National Depression Program, currently in effect, was implemented without a standardized training program. The objective of this study is to evaluate the acceptability of a training program on the management of depression for primary care health teams. The study was a randomized controlled trial, and two primary centers from the Metropolitan Region of Santiago were randomly selected to carry out the intervention training program. Pre-post surveys were applied, to evaluate expectations and satisfaction with the intervention, respectively. Descriptive and content analysis was carried out. The sample consisted of 41 health professionals, 56.1% of who reported that their expectations for the intervention were met. All of the training activities were evaluated with scores higher than 6.4 (on a 1-7 scale). The trainers, the methodology, and the learning environment were considered strengths and facilitators of the program, while the limited duration of the training, the logistical problems faced during part of the program, and the lack of educational material were viewed as weaknesses. The intervention was well accepted by primary health care teams. However, the clinical impact in patients still has to be evaluated.

A randomized, controlled trial of disability prevention in frail older patients screened in primary care: the FRASI study. Design and baseline evaluation.

PubMed

Bandinelli, Stefania; Lauretani, Fulvio; Boscherini, Vittorio; Gandi, Francesca; Pozzi, Martina; Corsi, Anna Maria; Bartali, Benedetta; Lova, Raffaello Molino; Guralnik, Jack M; Ferrucci, Luigi

2006-10-01

We describe the enrollment and intervention phases of FRASI (FRAilty, Screening and Intervention), a randomized controlled trial aimed at preventing ADL disability in frail older persons screened in primary care. Patients, 70-85 years old, non-disabled and noncognitively impaired, were screened for frailty (score < or = 9 on the Short Physical Performance Battery, SPPB) during primary care visits. Of 447 eligible persons, 410 came to the study clinic and 251 were randomized into treatment (n=126) and control groups (n=125). The active group received an intensive medical intervention, and sixteen 90-minute supervised exercise sessions over 8 weeks. The primary outcome was time to ADL disability onset or death in the 12-month period after study enrollment. The two study arms were similar for demographics, cognitive function, physical function and health status. Compared with a population-based sample selected according to FRASI inclusion criteria except SPPB score, FRASI participants had significantly worse health and functional status. Restricting the comparison to persons with SPPB < or = 9, all differences disappeared. The 99 participants (78.6% of 126) who completed the intervention participated in a mean of 15.3+/-1.6 exercise sessions. Screening in primary care for non-disabled, older persons with SPPB < or = 9 yields individuals with substantial morbidity, impairments and functional limitations that can be successfully involved in an intensive medical and exercise intervention. Whether such an intervention effectively prevents new disability remains to be confirmed.

Errors in causal inference: an organizational schema for systematic error and random error.

PubMed

Suzuki, Etsuji; Tsuda, Toshihide; Mitsuhashi, Toshiharu; Mansournia, Mohammad Ali; Yamamoto, Eiji

2016-11-01

To provide an organizational schema for systematic error and random error in estimating causal measures, aimed at clarifying the concept of errors from the perspective of causal inference. We propose to divide systematic error into structural error and analytic error. With regard to random error, our schema shows its four major sources: nondeterministic counterfactuals, sampling variability, a mechanism that generates exposure events and measurement variability. Structural error is defined from the perspective of counterfactual reasoning and divided into nonexchangeability bias (which comprises confounding bias and selection bias) and measurement bias. Directed acyclic graphs are useful to illustrate this kind of error. Nonexchangeability bias implies a lack of "exchangeability" between the selected exposed and unexposed groups. A lack of exchangeability is not a primary concern of measurement bias, justifying its separation from confounding bias and selection bias. Many forms of analytic errors result from the small-sample properties of the estimator used and vanish asymptotically. Analytic error also results from wrong (misspecified) statistical models and inappropriate statistical methods. Our organizational schema is helpful for understanding the relationship between systematic error and random error from a previously less investigated aspect, enabling us to better understand the relationship between accuracy, validity, and precision. Copyright © 2016 Elsevier Inc. All rights reserved.

Distribution of Orientation Selectivity in Recurrent Networks of Spiking Neurons with Different Random Topologies

PubMed Central

Sadeh, Sadra; Rotter, Stefan

2014-01-01

Neurons in the primary visual cortex are more or less selective for the orientation of a light bar used for stimulation. A broad distribution of individual grades of orientation selectivity has in fact been reported in all species. A possible reason for emergence of broad distributions is the recurrent network within which the stimulus is being processed. Here we compute the distribution of orientation selectivity in randomly connected model networks that are equipped with different spatial patterns of connectivity. We show that, for a wide variety of connectivity patterns, a linear theory based on firing rates accurately approximates the outcome of direct numerical simulations of networks of spiking neurons. Distance dependent connectivity in networks with a more biologically realistic structure does not compromise our linear analysis, as long as the linearized dynamics, and hence the uniform asynchronous irregular activity state, remain stable. We conclude that linear mechanisms of stimulus processing are indeed responsible for the emergence of orientation selectivity and its distribution in recurrent networks with functionally heterogeneous synaptic connectivity. PMID:25469704

Protocol of an ongoing randomized controlled trial of care management for comorbid depression and hypertension: the Chinese Older Adult Collaborations in Health (COACH) study.

PubMed

Chen, Shulin; Conwell, Yeates; Xue, Jiang; Li, Lydia W; Tang, Wan; Bogner, Hillary R; Dong, Hengjin

2018-05-29

Depression and hypertension are common, costly, and destructive conditions among the rapidly aging population of China. The two disorders commonly coexist and are poorly recognized and inadequately treated, especially in rural areas. The Chinese Older Adult Collaborations in Health (COACH) Study is a cluster randomized controlled trial (RCT) designed to test the hypotheses that the COACH intervention, designed to manage comorbid depression and hypertension in older adult, rural Chinese primary care patients, will result in better treatment adherence and greater improvement in depressive symptoms and blood pressure control, and better quality of life, than enhanced Care-as-Usual (eCAU). Based on chronic disease management and collaborative care principles, the COACH model integrates the care provided by the older person's primary care provider (PCP) with that delivered by an Aging Worker (AW) from the village's Aging Association, supervised by a psychiatrist consultant. One hundred sixty villages, each of which is served by one PCP, will be randomly selected from two counties in Zhejiang Province and assigned to deliver eCAU or the COACH intervention. Approximately 2400 older adult residents from the selected villages who have both clinically significant depressive symptoms and a diagnosis of hypertension will be recruited into the study, randomized by the villages in which they live and receive primary care. After giving informed consent, they will undergo a baseline research evaluation; receive treatment for 12 months with the approach to which their village was assigned; and be re-evaluated at 3, 6, 9, and 12 months after entry. Depression and HTN control are the primary outcomes. Treatment received, health care utilization, and cost data will be obtained from the subjects' electronic medical records (EMR) and used to assess adherence to care recommendations and, in a preliminary manner, to establish cost and cost effectiveness of the intervention. The COACH intervention is designed to serve as a model for primary care-based management of common mental disorders that occur in tandem with common chronic conditions of later life. It leverages existing resources in rural settings, integrates social interventions with the medical model, and is consistent with the cultural context of rural life. ClinicalTrials.gov ID: NCT01938963 ; First posted: September 10, 2013.

Perceptual expertise and top-down expectation of musical notation engages the primary visual cortex.

PubMed

Wong, Yetta Kwailing; Peng, Cynthia; Fratus, Kristyn N; Woodman, Geoffrey F; Gauthier, Isabel

2014-08-01

Most theories of visual processing propose that object recognition is achieved in higher visual cortex. However, we show that category selectivity for musical notation can be observed in the first ERP component called the C1 (measured 40-60 msec after stimulus onset) with music-reading expertise. Moreover, the C1 note selectivity was observed only when the stimulus category was blocked but not when the stimulus category was randomized. Under blocking, the C1 activity for notes predicted individual music-reading ability, and behavioral judgments of musical stimuli reflected music-reading skill. Our results challenge current theories of object recognition, indicating that the primary visual cortex can be selective for musical notation within the initial feedforward sweep of activity with perceptual expertise and with a testing context that is consistent with the expertise training, such as blocking the stimulus category for music reading.

Effects on readiness to change of an educational intervention on depressive disorders for general physicians in primary care based on a modified Prochaska model--a randomized controlled study.

PubMed

Shirazi, M; Zeinaloo, A A; Parikh, S V; Sadeghi, M; Taghva, A; Arbabi, M; Kashani, A Sabouri; Alaeddini, F; Lonka, K; Wahlström, R

2008-04-01

The Prochaska model of readiness to change has been proposed to be used in educational interventions to improve medical care. To evaluate the impact on readiness to change of an educational intervention on management of depressive disorders based on a modified version of the Prochaska model in comparison with a standard programme of continuing medical education (CME). This is a randomized controlled trial within primary care practices in southern Tehran, Iran. The participants included 192 general physicians working in primary care (GPs) were recruited after random selection and randomized to intervention (96) and control (96). Intervention consisted of interactive, learner-centred educational methods in large and small group settings depending on the GPs' stages of readiness to change. Change in stage of readiness to change measured by the modified version of the Prochaska questionnaire was the The final number of participants was 78 (81%) in the intervention arm and 81 (84%) in the control arm. Significantly (P < 0.01), more GPs (57/96 = 59% versus 12/96 = 12%) in the intervention group changed to higher stages of readiness to change. The intervention effect was 46% points (P < 0.001) and 50% points (P < 0.001) in the large and small group setting, respectively. Educational formats that suit different stages of learning can support primary care doctors to reach higher stages of behavioural change in the topic of depressive disorders. Our findings have practical implications for conducting CME programmes in Iran and are possibly also applicable in other parts of the world.

Proven in vitro evolution of protease cathepsin E-inhibitors and -activators at pH 4.5 using a paired peptide method.

PubMed

Kitamura, Koichiro; Komatsu, Masayuki; Biyani, Madhu; Futakami, Masae; Kawakubo, Tomoyo; Yamamoto, Kenji; Nishigaki, Koichi

2012-12-01

Improving a particular function of molecules is often more difficult than identifying such molecules ab initio. Here, a method to acquire higher affinity and/or more functional peptides was developed as a progressive library selection method. The primary library selection products were utilized to build a secondary library composed of blocks of 4 amino acids, of which selection led to peptides with increased activity. These peptides were further converted to randomly generate paired peptides. Cathepsin E-inhibitors thus obtained exhibited the highest activities and affinities (pM order). This was also the case with cathepsin E-activating peptides, proving the methodological effectiveness. The primary, secondary, and tertiary library selections can be regarded as module-finding, module-shuffling, and module-pairing, respectively, which resembles the progression of the natural evolution of proteins. The mode of peptide binding to their target proteins is discussed in analogy to antibodies and epitopes of an antigen. Copyright © 2012 European Peptide Society and John Wiley & Sons, Ltd.

Evaluation of Four Pulpotomy Techniques in Primary Molars: A Randomized Controlled Trial

PubMed Central

Ansari, Ghassem; Morovati, Seyyedeh Pouya; Asgary, Saeed

2018-01-01

Introduction: This trial was designed to evaluate the clinical and radiographic success rates of calcium-enriched mixture (CEM) cement with and without low level laser therapy (LLLT) and compare them to that of formocresol (FC) and ferric sulfate (FS) in primary molar pulpotomies. Methods and Materials: This randomized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3-9 years. Patients with at least four primary molars needing pulpotomy, were included in order to have each tooth assigned randomly in one of the four following groups; FC, FS, CEM, and LLLT/CEM. Six- and twelve-month follow-up periods were conducted in order to enable a clinical and radiographic evaluation of the treated teeth. Collected data were analyzed using Cochran Q Tests. Results: The 12-month clinical success rate for each technique was: FC=100%, FS=95%, CEM=97.5% and LLLT/CEM=100% with no significant differences (P>0.05). Furthermore, 12-month radiographic success rate for each technique was: FC=100%, FS=92.5%, CEM=95% and LLLT/CEM=100% with no significant differences (P>0.05). Conclusion: Favorable outcomes of four treatment techniques in pulpotomy of primary molar teeth were comparable. CEM with/without LLLT may be considered as a safe and successful pulpotomy treatment modality compared to current conventional methods. PMID:29692828

Investigating Organizational Alienation Behavior in Terms of Some Variables

ERIC Educational Resources Information Center

Dagli, Abidin; Averbek, Emel

2017-01-01

The aim of this study is to detect the perceptions of public primary school teachers regarding organizational alienation behaviors in terms of some variables (gender, marital status and seniority). Survey model was used in this study. The research sample consists of randomly selected 346 teachers from 40 schools in the central district of Mardin,…

Depression Screening Patterns for Women in Rural Health Clinics

ERIC Educational Resources Information Center

Tudiver, Fred; Edwards, Joellen Beckett; Pfortmiller, Deborah T.

2010-01-01

Context: Rates and types of screening for depression in rural primary care practices are unknown. Purpose: To identify rates of depression screening among rural women in a sample of rural health clinics (RHCs). Methods: A chart review of 759 women's charts in 19 randomly selected RHCs across the nation. Data were collected from charts of female…

Implementing Structured English Immersion in Arizona: Benefits, Costs, Challenges, and Opportunities

ERIC Educational Resources Information Center

Rios-Aguilar, Cecilia; Gonzalez-Canche, Manuel; Moll, Luis C.

2010-01-01

This study conducted telephone interviews with 26 randomly selected English Language Coordinators from 26 Arizona school districts with enrollment patterns that were representative of the state as whole. Three primary questions were posed to the respondents: (a) How is the 4-hour ELD block being implemented?; (b) What are the benefits of the…

Assessing Changes in Socioemotional Adjustment across Early School Transitions--New National Scales for Children at Risk

ERIC Educational Resources Information Center

McDermott, Paul A.; Watkins, Marley W.; Rovine, Michael J.; Rikoon, Samuel H.

2013-01-01

This article reports the development and evidence for validity and application of the Adjustment Scales for Early Transition in Schooling (ASETS). Based on primary analyses of data from the Head Start Impact Study, a nationally representative sample (N = 3077) of randomly selected children from low-income households is configured to inform…

Relationship between Psychological Well-Being and Smartphone Addiction of University Students

ERIC Educational Resources Information Center

Kumcagiz, Hatice; Gündüz, Yüksel

2016-01-01

This study was carried out to examine the relationship between university students' levels of psychological well-being and smartphone addiction. The study group consists of a total of 408 students (303 female and 105 male) selected by random sampling method and studying at the departments of Primary Education, Science Teaching, Art and Crafts…

Ethical Leadership and Teachers' Voice Behavior: The Mediating Roles of Ethical Culture and Psychological Safety

ERIC Educational Resources Information Center

Sagnak, Mesut

2017-01-01

The purpose of this study is to investigate the mediating effects of ethical culture and psychological safety on the relationship between ethical leadership and teachers' voice behavior. The sample consists of 342 teachers randomly selected from 25 primary and secondary schools. Four different instruments are used in this study. The scales have…

Primary Education in Vietnam and Pupil Online Engagement

ERIC Educational Resources Information Center

Nguyen, Quynh Thi; Naguib, Raouf N. G.; Das, Ashish K.; Papathomas, Michail; Vallar, Edgar A.; Wickramasinghe, Nilmini; Santos, Gil Nonato; Galvez, Maria Cecilia; Nguyen, Viet Anh

2018-01-01

Purpose: The purpose of this paper is to explore the disparities in social awareness and use of the internet between urban and rural school children in the North of Vietnam. Design/methodology/approach: A total of 525 pupils, aged 9-11 years old, randomly selected from seven urban and rural schools, who are internet users, participated in the…

Teachers' Continuing Professional Development as Correlates of Sustainable Universal Basic Education in Bayelsa State, Nigeria

ERIC Educational Resources Information Center

Iyunade, Olufunmilayo T.

2017-01-01

The study examined the correlates of teachers' continuing professional development on universal basic education in Bayelsa State, Nigeria. Using descriptive survey, a sample of 500 teachers was randomly selected from twenty (20) Basic Junior Secondary Schools and Primary Schools used for the study. The instrument used for data collection was a…

Teachers' Difficulties in Preparation and Implementation of Performance Task

ERIC Educational Resources Information Center

Metin, Mustafa

2013-01-01

The aim of study is to determinate the difficulties of teachers in preparation and implementation of performance task. This study was carried out with 25 teachers (5 science and technology, 5 primary, 5 mathematic, 5 social science and 5 Turkish teachers) who working at elementary schools in Artvin. Sample of study is selected randomly. Case study…

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

PubMed

Zhang, Sheng; Liang, Fei; Li, Wenfeng

2017-11-01

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

Combined universal and selective prevention for adolescent alcohol use: a cluster randomized controlled trial.

PubMed

Teesson, M; Newton, N C; Slade, T; Carragher, N; Barrett, E L; Champion, K E; Kelly, E V; Nair, N K; Stapinski, L A; Conrod, P J

2017-07-01

No existing models of alcohol prevention concurrently adopt universal and selective approaches. This study aims to evaluate the first combined universal and selective approach to alcohol prevention. A total of 26 Australian schools with 2190 students (mean age: 13.3 years) were randomized to receive: universal prevention (Climate Schools); selective prevention (Preventure); combined prevention (Climate Schools and Preventure; CAP); or health education as usual (control). Primary outcomes were alcohol use, binge drinking and alcohol-related harms at 6, 12 and 24 months. Climate, Preventure and CAP students demonstrated significantly lower growth in their likelihood to drink and binge drink, relative to controls over 24 months. Preventure students displayed significantly lower growth in their likelihood to experience alcohol harms, relative to controls. While adolescents in both the CAP and Climate groups demonstrated slower growth in drinking compared with adolescents in the control group over the 2-year study period, CAP adolescents demonstrated faster growth in drinking compared with Climate adolescents. Findings support universal, selective and combined approaches to alcohol prevention. Particularly novel are the findings of no advantage of the combined approach over universal or selective prevention alone.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

PubMed

Zick, Suzanna M; Wright, Benjamin D; Sen, Ananda; Arnedt, J Todd

2011-09-22

Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

Dentists' Preferences for Diagnosis, Management and Referral of Chronic Oro-Facial Pain: Results from a National Survey

ERIC Educational Resources Information Center

Aggarwal, Vishal R.; Joughin, Amy; Zakrzewska, Joanna; Appelbe, Priscilla; Tickle, Martin

2012-01-01

Aim: To explore the diagnosis, treatment and referral patterns of chronic oro-facial pain patients by generalist primary care dentists (GDPs) in the UK. Methods: A cross-sectional survey was conducted using a non-stratified random sample of 500 GDPs who were selected from the General Dental Council register. A self-complete postal questionnaire…

Effect of Demographic Factors on E-Learning Effectiveness in a Higher Learning Institution in Malaysia

ERIC Educational Resources Information Center

Islam, Md. Aminul; Rahim, Noor Asliza Abdul; Liang, Tan Chee; Momtaz, Hasina

2011-01-01

This research attempted to find out the effect of demographic factors on the effectiveness of the e-learning system in a higher learning Institution. The students from this institution were randomly selected in order to evaluate the effectiveness of learning system in student's learning process. The primary data source is the questionnaires that…

States of Matter Explanations in Slovenian Textbooks for Students Aged 6 to 14

ERIC Educational Resources Information Center

Devetak, Iztok; Vogrinc, Janez; Glazar, Sasa A.

2010-01-01

The basic aim of this study is to investigate the content of textual and pictorial material of Slovenian science textbooks and notebooks on topic states of matter. The paper presents the results of the analysis of educational material from two randomly selected publishers for students aged 6 to 14 in the Slovenian primary and the lower secondary…

Baseline Survey of Sun Protection Policies and Practices in Primary School Settings in New Zealand

ERIC Educational Resources Information Center

Reeder, A. I.; Jopson, J. A.; Gray, A.

2009-01-01

The SunSmart Schools Accreditation Programme (SSAP) was launched as a national programme in October 2005 to help reduce the risk of excessive child exposure to ultraviolet radiation. As part of the need for evaluation, this paper reports the findings of a national survey of a randomly selected sample of approximately 12% of New Zealand primary…

A Study of the Relationship between Academic Achievement Motivation and Home Environment among Standard Eight Pupils

ERIC Educational Resources Information Center

Muola, J. M.

2010-01-01

The objective of this study was to investigate the relationship between academic achievement motivation and home environment among standard eight pupils. The study was carried out on 235 standard eight Kenyan pupils from six urban and rural primary schools randomly selected from Machakos district. Their age ranged between 13 and 17 years. Two…

Bridging the Gap: A Longitudinal Study of the Relationship between Pedagogical Continuity and Early Chinese Literacy Acquisition

ERIC Educational Resources Information Center

Li, Hui; Rao, Nirmala; Tse, Shek Kam

2011-01-01

This longitudinal study examined the relationship between pedagogical continuity in literacy education and early literacy development by comparing Chinese children in Hong Kong and Shenzhen. Stratified random sampling was used to select 24 preschool and Primary 1 classes in four communities catering to middle-class families in each city. The 24…

Investigation of the Relationship between the Spatial Visualization Success and Visual/Spatial Intelligence Capabilities of Sixth Grade Students

ERIC Educational Resources Information Center

Yenilmez, Kursat; Kakmaci, Ozlem

2015-01-01

The main aim of this research was to examine the relationship between the spatial visualization success and visual/spatial intelligence capabilities of sixth grade students. The sample of the research consists of 1011 sixth grade students who were randomly selected from the primary schools in Eskisehir. In this correlational study, data were…

A Study on Primary School Teacher Burnout Levels: The Northern Cyprus Case

ERIC Educational Resources Information Center

Ozan, Mukadder Boydak

2009-01-01

The study population included the 1482 teachers who were working at the 98 schools affiliated to the Ministry of National Education and Culture in Lefkosa, Girne, Gazimagusa and Guzelyurt during the 2007-2008 academic year. The sample comprised 196 teachers from 14 of these schools which were selected randomly. Data was collected by using the (1)…

Chile: Acceptability of a Training Program for Depression Management in Primary Care

PubMed Central

Marín, Rigoberto; Martínez, Pablo; Cornejo, Juan P.; Díaz, Berta; Peralta, José; Tala, Álvaro; Rojas, Graciela

2016-01-01

Background: In Chile, there are inconsistencies in the management of depression in primary care settings, and the National Depression Program, currently in effect, was implemented without a standardized training program. The objective of this study is to evaluate the acceptability of a training program on the management of depression for primary care health teams. Methods: The study was a randomized controlled trial, and two primary centers from the Metropolitan Region of Santiago were randomly selected to carry out the intervention training program. Pre-post surveys were applied, to evaluate expectations and satisfaction with the intervention, respectively. Descriptive and content analysis was carried out. Result: The sample consisted of 41 health professionals, 56.1% of who reported that their expectations for the intervention were met. All of the training activities were evaluated with scores higher than 6.4 (on a 1–7 scale). The trainers, the methodology, and the learning environment were considered strengths and facilitators of the program, while the limited duration of the training, the logistical problems faced during part of the program, and the lack of educational material were viewed as weaknesses. Conclusion: The intervention was well accepted by primary health care teams. However, the clinical impact in patients still has to be evaluated. PMID:27375531

Renal calyceal anatomy characterization with 3-dimensional in vivo computerized tomography imaging.

PubMed

Miller, Joe; Durack, Jeremy C; Sorensen, Mathew D; Wang, James H; Stoller, Marshall L

2013-02-01

Calyceal selection for percutaneous renal access is critical for safe, effective performance of percutaneous nephrolithotomy. Available anatomical evidence is contradictory and incomplete. We present detailed renal calyceal anatomy obtained from in vivo 3-dimentional computerized tomography renderings. A total of 60 computerized tomography urograms were randomly selected. The renal collecting system was isolated and 3-dimensional renderings were constructed. The primary plane of each calyceal group of 100 kidneys was determined. A coronal maximum intensity projection was used for simulated percutaneous access. The most inferior calyx was designated calyx 1. Moving superiorly, the subsequent calyces were designated calyx 2 and, when present, calyx 3. The surface rendering was rotated to assess the primary plane of the calyceal group and the orientation of the select calyx. The primary plane of the upper pole calyceal group was mediolateral in 95% of kidneys and the primary plane of the lower pole calyceal group was anteroposterior in 95%. Calyx 2 was chosen in 90 of 97 simulations and it was appropriate in 92%. Calyx 3 was chosen in 7 simulations but it was appropriate in only 57%. Calyx 1 was not selected in any simulation and it was anteriorly oriented in 75% of kidneys. Appropriate lower pole calyceal access can be reliably accomplished with an understanding of the anatomical relationship between individual calyceal orientation and the primary plane of the calyceal group. Calyx 2 is most often appropriate for accessing the anteroposterior primary plane of the lower pole. Calyx 1 is most commonly oriented anterior. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Identification of chondrocyte-binding peptides by phage display.

PubMed

Cheung, Crystal S F; Lui, Julian C; Baron, Jeffrey

2013-07-01

As an initial step toward targeting cartilage tissue for potential therapeutic applications, we sought cartilage-binding peptides using phage display, a powerful technology for selection of peptides that bind to molecules of interest. A library of phage displaying random 12-amino acid peptides was iteratively incubated with cultured chondrocytes to select phage that bind cartilage. The resulting phage clones demonstrated increased affinity to chondrocytes by ELISA, when compared to a wild-type, insertless phage. Furthermore, the selected phage showed little preferential binding to other cell types, including primary skin fibroblast, myocyte and hepatocyte cultures, suggesting a tissue-specific interaction. Immunohistochemical staining revealed that the selected phage bound chondrocytes themselves and the surrounding extracellular matrix. FITC-tagged peptides were synthesized based on the sequence of cartilage-binding phage clones. These peptides, but not a random peptide, bound cultured chondrocytes, and extracelluar matrix. In conclusion, using phage display, we identified peptide sequences that specifically target chondrocytes. We anticipate that such peptides may be coupled to therapeutic molecules to provide targeted treatment for cartilage disorders. Copyright © 2013 Orthopaedic Research Society.

Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1).

PubMed

Jänne, Pasi A; Mann, Helen; Ghiorghiu, Dana

2016-03-01

Oncogenic KRAS mutations represent the largest genomically defined subset of lung cancer, and are associated with activation of the RAS/RAF/MEK/ERK pathway. There are currently no therapies specifically approved for patients with KRAS-mutant (KRASm) non-small-cell lung cancer (NSCLC), and these patients derive less clinical benefit from chemotherapy than the overall NSCLC population. In a recent phase II study, selumetinib (AZD6244, ARRY-142886), an oral, potent and selective, allosteric MEK1/2 inhibitor with a short half-life, combined with docetaxel, improved clinical outcome as second-line treatment for patients with KRASm NSCLC. This combination will be further evaluated in the phase III SELECT-1 study. SELECT-1 (NCT01933932) is a randomized, double-blind, placebo-controlled phase III study assessing the efficacy and safety of selumetinib plus docetaxel in patients with KRASm locally advanced or metastatic NSCLC, eligible for second-line treatment. The primary endpoint is progression-free survival (PFS); secondary endpoints include overall survival, objective response rate, duration of response, and safety and tolerability. Approximately 634 patients will be randomized 1:1 to receive selumetinib (75 mg twice daily on a continuous oral administration schedule) in combination with docetaxel (75 mg/m(2), intravenously on day 1 of every 21-day cycle) or placebo in combination with docetaxel (same schedule), until objective disease progression. Patients may continue to receive treatment after objective disease progression if deemed appropriate by the investigator. If the primary endpoint of PFS is met, selumetinib plus docetaxel would be the first targeted treatment for patients with KRASm advanced NSCLC who are eligible for second-line treatment. Copyright © 2016 Elsevier Inc. All rights reserved.

Barriers to management of cardiovascular risk in a low-resource setting using hypertension as an entry point.

PubMed

Mendis, Shanthi; Abegunde, Dele; Oladapo, Olulola; Celletti, Francesca; Nordet, Porfirio

2004-01-01

Assess capacity of health-care facilities in a low-resource setting to implement the absolute risk approach for assessment of cardiovascular risk in hypertensive patients and effective management of hypertension. A descriptive cross-sectional study in Egbeda and Oluyole local government areas of Oyo State in Nigeria in 56 randomly selected primary- (n = 42) and secondary-level (n = 2) health-care and private health-care (n = 12) facilities. One thousand consecutive, known hypertensives attending the selected facilities for follow-up, and health-care providers working in the above randomly selected facilities, were interviewed. About two-thirds of hypertensives utilized primary-care centers both for diagnosis and for follow-up. Laboratory and other investigations to exclude secondary hypertension or to assess target organ damage were not available in the majority of facilities, particularly in primary care. A considerable knowledge and awareness gap related to hypertension and its complications was found, both among patients and health-care providers. Blood pressure control rates were poor (28% with systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg] and drug prescription patterns were not evidence based and cost effective. The majority of patients (73%) in this low socio-economic group (mean monthly income 73 US dollars) had to pay fully, out of their own pocket, for consultations and medications. If the absolute risk approach for assessment of risk and effective management of hypertension is to be implemented in low-resource settings, appropriate policy measures need to be taken to improve the competency of health-care providers, to provide basic laboratory facilities and to develop affordable financing mechanisms.

Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial.

PubMed

Korteland, Nelleke M; Ahmed, Yunus; Koolbergen, David R; Brouwer, Marjan; de Heer, Frederiek; Kluin, Jolanda; Bruggemans, Eline F; Klautz, Robert J M; Stiggelbout, Anne M; Bucx, Jeroen J J; Roos-Hesselink, Jolien W; Polak, Peter; Markou, Thanasie; van den Broek, Inge; Ligthart, Rene; Bogers, Ad J J C; Takkenberg, Johanna J M

2017-02-01

A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection. In a 5-center randomized controlled trial, patients were allocated to receive either standard preoperative care (control group) or additional access to the patient decision aid (intervention group). Legally capable adult patients accepted for elective isolated or combined aortic and mitral valve replacement were included. Primary outcome was preoperative decisional conflict (Decisional Conflict Scale); secondary outcomes included patient knowledge, involvement in valve selection, anxiety and depression, (valve-specific) quality of life, and regret. Out of 306 eligible patients, 155 were randomized (78 control and 77 intervention). Preoperative decisional conflict did not differ between the groups (34% versus 33%; P =0.834). Intervention patients felt better informed (median Decisional Conflict Scale informed subscore: 8 versus 17; P =0.046) and had a better knowledge of prosthetic valves (85% versus 68%; P =0.004). Intervention patients experienced less anxiety and depression (median Hospital Anxiety and Depression Scale score: 6 versus 9; P =0.015) and better mental well-being (mean Short Form Health Survey score: 54 versus 50; P =0.032). Three months postoperatively, valve-specific quality of life and regret did not differ between the groups. A patient decision aid to support shared decision making in prosthetic heart valve selection does not lower decisional conflict. It does result in more knowledgeable, better informed, and less anxious and depressed patients, with a better mental well-being. http://www.trialregister.nl. Unique identifier: NTR4350. © 2017 American Heart Association, Inc.

Phenotypic Screening for Friedreich Ataxia Using Random shRNA Selection.

PubMed

Cotticelli, M Grazia; Acquaviva, Fabio; Xia, Shujuan; Kaur, Avinash; Wang, Yongping; Wilson, Robert B

2015-10-01

Friedreich ataxia (FRDA) is an autosomal recessive neuro- and cardio-degenerative disorder for which there are no proven effective treatments. FRDA is caused by decreased expression and/or function of the protein frataxin. Frataxin chaperones iron in the mitochondrial matrix and regulates the iron-sulfur cluster (ISC) assembly complex. ISCs are prosthetic groups critical for the function of the Krebs cycle and the mitochondrial electron transport chain. Decreased expression of frataxin is associated with decreased ISC assembly, mitochondrial iron accumulation, and increased oxidative stress, all of which contribute to mitochondrial dysfunction. In media with beta-hydroxybutyrate (BHB) as carbon source, primary FRDA fibroblasts grow poorly and/or lose viability over several days. We screened a random, short-hairpin-RNA (shRNA)-expressing library in primary FRDA fibroblasts and identified two shRNAs that reverse the growth/viability defect in BHB media. One of these two clones increases frataxin expression in primary FRDA fibroblasts, either as a vector-expressed shRNA or as a transfected short-interfering RNA (siRNA). © 2015 Society for Laboratory Automation and Screening.

The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

PubMed

Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

2015-01-01

To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design.

PubMed

Rush, A John; Fava, Maurizio; Wisniewski, Stephen R; Lavori, Philip W; Trivedi, Madhukar H; Sackeim, Harold A; Thase, Michael E; Nierenberg, Andrew A; Quitkin, Frederic M; Kashner, T Michael; Kupfer, David J; Rosenbaum, Jerrold F; Alpert, Jonathan; Stewart, Jonathan W; McGrath, Patrick J; Biggs, Melanie M; Shores-Wilson, Kathy; Lebowitz, Barry D; Ritz, Louise; Niederehe, George

2004-02-01

STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.

HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial.

PubMed

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

2015-12-15

Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced patients in the absence of data from randomized trials. To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394). Outpatient HIV clinics. Treatment-experienced patients with HIV infection and viral resistance. Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. 360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, -6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. Unblinded study design, and the study may not be applicable to resource-poor settings. Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).

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

PubMed Central

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

2015-01-01

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

Can Schools Offer Solutions to Small-Scale Farmers in Africa? Analysis of the Socioeconomic Benefits of Primary School Agriculture in Uganda

ERIC Educational Resources Information Center

Okiror, John James; Oonyu, Joseph; Matsiko, Frank; Kibwika, Paul

2011-01-01

Agriculture;This paper discusses the factors influencing application of school gardening knowledge and skills by pupils at school and household level; and whether pupils are effective sources of information to their parents. A quasi-experimental design was used to compare cohorts of 30 pupils randomly selected from eight schools in Kumi and Tororo…

A Preliminary Study on Motivation and Gender in CLIL and Non-CLIL Types of Instruction

ERIC Educational Resources Information Center

Fontecha, Almudena Fernández; Alonso, Andrés Canga

2014-01-01

This paper sets out to enquiry about gender-based differences in motivation towards EFL in two different types of instruction, i.e. CLIL and EFL (non-CLIL). The study was carried out with 4th Primary education Spanish students randomly selected from two mixed-gender schools in La Rioja (Spain). The results show that non-CLIL learners are…

The Construction of a Muscular Strength Test Battery for Girls in the Primary Grades.

ERIC Educational Resources Information Center

DiNucci, James M.; Pelton, Elois B.

This study was designed to construct a gross muscular strength test battery for girls 6-9 years of age in grades 1-3. The subjects for this investigation were a random sample of 183 girls in grades 1-3 of the public schools of Natchitoches, Louisiana. The variables selected were 22 cable tension strength tests developed by Clarke and associates.…

A Study on Young Turkish Students' Living Thing Conception

ERIC Educational Resources Information Center

Özgur, Sami

2018-01-01

The aim of this study is to find out young Turkish students' opinions about living thing concept in detail and to investigate the criteria used by the students to define this concept. The study sample consisted of randomly selected 140 students studying at the 3rd, 4th and 5th grades in four different primary and middle schools located in the…

The Contribution of Teachers' Continuous Professional Development (CPD) Program to Quality of Education and Its Teacher-Related Challenging Factors at Chagni Primary Schools, Awi Zone, Ethiopia

ERIC Educational Resources Information Center

Belay, Sintayehu

2016-01-01

This study examined the contribution of teachers' Continuous Professional Development (CPD) to quality of education and its challenging factors related with teachers. For this purpose, the study employed descriptive survey method. 76 or 40.86% participant teachers were selected using simple random sampling technique. Close-ended questionnaire was…

Antibiotics for URTI and UTI -- prescribing in Malaysian primary care settings.

PubMed

Teng, Cheong Lieng; Tong, Seng Fah; Khoo, Ee Ming; Lee, Verna; Zailinawati, Abu Hassan; Mimi, Omar; Chen, Wei Seng; Nordin, Salleh

2011-05-01

Overprescription of antibiotics is a continuing problem in primary care. This study aims to assess the antibiotic prescribing rates and antibiotic choices for upper respiratory tract infections (URTI) and urinary tract infections (UTI) in Malaysian primary care. Antibiotic prescribing data for URTI and UTI was extracted from a morbidity survey of randomly selected primary care clinics in Malaysia. Analysis was performed of 1,163 URTI and 105 UTI encounters. Antibiotic prescribing rates for URTI and UTI were 33.8% and 57.1% respectively. Antibiotic prescribing rates were higher in private clinics compared to public clinics for URTI, but not for UTI. In URTI encounters, the majority of antibiotics prescribed were penicillins and macrolides, but penicillin V was notably underused. In UTI encounters, the antibiotics prescribed were predominantly penicillins or cotrimoxazole. Greater effort is needed to bring about evidence based antibiotic prescribing in Malaysian primary care, especially for URTIs in private clinics.

Prevalence, diagnostics and management of musculoskeletal disorders in primary health care in Sweden – an investigation of 2000 randomly selected patient records

PubMed Central

Fahlström, Martin; Djupsjöbacka, Mats

2016-01-01

Abstract Rationale, aims and objectives The aims of this study is to investigate the prevalence of patients seeking care due to different musculoskeletal disorders (MSDs) at primary health care centres (PHCs), to chart different factors such as symptoms, diagnosis and actions prescribed for patients that visited the PHCs due to MSD and to make comparisons regarding differences due to gender, age and rural or urban PHC. Methods Patient records (2000) for patients in working age were randomly selected equally distributed on one rural and one urban PHC. A 3‐year period was reviewed retrospectively. For all patient records' background data, cause to the visit and diagnosis were registered. For visits due to MSD, type and location of symptoms and actions to resolve the patients problems were registered. Data was analysed using cross tabulation, multidimensional chi‐squared. Results The prevalence of MSD was high; almost 60% of all patients were seeking care due to MSD. Upper and lower limb problems were most common. Symptoms were most prevalent in the young and middle age groups. The patients got a variety of different diagnoses, and between 13 and 35% of the patients did not receive a MSD diagnose despite having MSD symptoms. There was a great variation in how the cases were handled. Conclusions The present study points out some weaknesses regarding diagnostics and management of MSD in primary care. PMID:27538347

Prevalence, diagnostics and management of musculoskeletal disorders in primary health care in Sweden - an investigation of 2000 randomly selected patient records.

PubMed

Wiitavaara, Birgitta; Fahlström, Martin; Djupsjöbacka, Mats

2017-04-01

The aims of this study is to investigate the prevalence of patients seeking care due to different musculoskeletal disorders (MSDs) at primary health care centres (PHCs), to chart different factors such as symptoms, diagnosis and actions prescribed for patients that visited the PHCs due to MSD and to make comparisons regarding differences due to gender, age and rural or urban PHC. Patient records (2000) for patients in working age were randomly selected equally distributed on one rural and one urban PHC. A 3-year period was reviewed retrospectively. For all patient records' background data, cause to the visit and diagnosis were registered. For visits due to MSD, type and location of symptoms and actions to resolve the patients problems were registered. Data was analysed using cross tabulation, multidimensional chi-squared. The prevalence of MSD was high; almost 60% of all patients were seeking care due to MSD. Upper and lower limb problems were most common. Symptoms were most prevalent in the young and middle age groups. The patients got a variety of different diagnoses, and between 13 and 35% of the patients did not receive a MSD diagnose despite having MSD symptoms. There was a great variation in how the cases were handled. The present study points out some weaknesses regarding diagnostics and management of MSD in primary care. © 2016 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

PubMed

Li, Nicole; Yan, Lijing L; Niu, Wenyi; Labarthe, Darwin; Feng, Xiangxian; Shi, Jingpu; Zhang, Jianxin; Zhang, Ruijuan; Zhang, Yuhong; Chu, Hongling; Neiman, Andrea; Engelgau, Michael; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

2013-11-01

Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine. The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide. © 2013.

Emergence of Primary Teeth in Children of Sunsari District of Eastern Nepal

PubMed Central

Gupta, Anita; Hiremath, SS; Singh, SK; Poudyal, S; Niraula, SR; Baral, DD; Singh, RK

2007-01-01

This study assessed the timing and eruption sequence of primary teeth in children of Sunsari district of Eastern Nepal and compared the eruption pattern of males & females between various, ethnic groups. Method This cross-sectional study, included 501 subjects, aged 3 months to 60 months selected by simple random sampling method. The determinant variables such as age, gender, ethnicity, and eruption of teeth were recorded. Results This study provides a model data on emergence of primary teeth and number of deciduous teeth in these children. This is a first study of its kind in Nepal. The findings of this study will help as a reference data for optimal use in clinical, academic, and research activities, especially for children of Eastern Nepal. PMID:18523631

The effect of asthma education program on knowledge of school teachers: a randomized controlled trial.

PubMed

Kawafha, Mariam M; Tawalbeh, Loai Issa

2015-04-01

The purpose of this study was to examine the effect of an asthma education program on schoolteachers' knowledge. Pre-test-post-test experimental randomized controlled design was used. A multistage-cluster sampling technique was used to randomly select governorate, primary schools, and schoolteachers. Schoolteachers were randomly assigned either to the experimental group (n = 36) and attended three educational sessions or to the control group (n = 38) who did not receive any intervention. Knowledge about asthma was measured using the Asthma General Knowledge Questionnaire for Adults (AGKQA). The results indicated that teachers in the experimental group showed significantly (p < .001) higher knowledge of asthma in the first post-test and the second post-test compared with those in the control group. Implementing asthma education enhanced schoolteachers' knowledge of asthma. The asthma education program should target schoolteachers to improve knowledge about asthma. © The Author(s) 2014.

Effect of short-term hazelnut consumption on DNA damage and oxidized LDL in children and adolescents with primary hyperlipidemia: a randomized controlled trial.

PubMed

Guaraldi, Federica; Deon, Valeria; Del Bo', Cristian; Vendrame, Stefano; Porrini, Marisa; Riso, Patrizia; Guardamagna, Ornella

2018-07-01

Children with primary hyperlipidemia are prone to develop premature atherosclerosis, possibly associated with increased oxidative stress. Nutritional therapy is the primary strategy in the treatment of hyperlipidemia and associated conditions. Dietary interventions with bioactive-rich foods, such as nuts, may contribute to the modulation of both lipid profile and the oxidative/antioxidant status. Our study aimed to assess the impact of a dietary intervention with hazelnuts on selected oxidative stress markers in children and adolescents with primary hyperlipidemia. A single-blind, 8-week, randomized, controlled, three-arm, parallel-group study was performed. Children and adolescents diagnosed with primary hyperlipidemia (n=60) received dietary guidelines and were randomized into three groups: group 1 received hazelnuts with skin (HZN+S), and group 2 hazelnuts without skin (HZN-S), at equivalent doses (15-30 g/day, based on body weight); group 3 (controls) received only dietary recommendations (no nuts). At baseline and after 8 weeks, plasma oxidized low-density lipoprotein (ox-LDL) concentrations, oxidative levels of DNA damage in PBMCs and potential correlation with changes in serum lipids were examined. A reduction of endogenous DNA damage by 18.9%±51.3% (P=.002) and 23.1%±47.9% (P=.007) was observed after HZN+S and HZN-S, respectively. Oxidatively induced DNA strand breaks decreased by 16.0%±38.2% (P=.02) following HZN+S treatment. Ox-LDL levels did not change after HZN+S intervention but positively correlated with total cholesterol and LDL cholesterol. A short-term hazelnut intervention improves cell DNA protection and resistance against oxidative stress but not ox-LDL in hyperlipidemic pediatric patients. The trial was registered at ISRCTN.com, ID no. ISRCTN12261900. Copyright © 2018 Elsevier Inc. All rights reserved.

A structured framework for assessing sensitivity to missing data assumptions in longitudinal clinical trials.

PubMed

Mallinckrodt, C H; Lin, Q; Molenberghs, M

2013-01-01

The objective of this research was to demonstrate a framework for drawing inference from sensitivity analyses of incomplete longitudinal clinical trial data via a re-analysis of data from a confirmatory clinical trial in depression. A likelihood-based approach that assumed missing at random (MAR) was the primary analysis. Robustness to departure from MAR was assessed by comparing the primary result to those from a series of analyses that employed varying missing not at random (MNAR) assumptions (selection models, pattern mixture models and shared parameter models) and to MAR methods that used inclusive models. The key sensitivity analysis used multiple imputation assuming that after dropout the trajectory of drug-treated patients was that of placebo treated patients with a similar outcome history (placebo multiple imputation). This result was used as the worst reasonable case to define the lower limit of plausible values for the treatment contrast. The endpoint contrast from the primary analysis was - 2.79 (p = .013). In placebo multiple imputation, the result was - 2.17. Results from the other sensitivity analyses ranged from - 2.21 to - 3.87 and were symmetrically distributed around the primary result. Hence, no clear evidence of bias from missing not at random data was found. In the worst reasonable case scenario, the treatment effect was 80% of the magnitude of the primary result. Therefore, it was concluded that a treatment effect existed. The structured sensitivity framework of using a worst reasonable case result based on a controlled imputation approach with transparent and debatable assumptions supplemented a series of plausible alternative models under varying assumptions was useful in this specific situation and holds promise as a generally useful framework. Copyright © 2012 John Wiley & Sons, Ltd.

Comparison of Antimicrobial Efficacy of Diode Laser, Triphala, and Sodium Hypochlorite in Primary Root Canals: A Randomized Controlled Trial

PubMed Central

Asokan, Sharath; John, Baby; Priya, Geetha; Kumar, S

2017-01-01

Aim To evaluate the antimicrobial efficacy of diode laser, triphala, and sodium hypochlorite (NaOCl) against Enterococc-cus faecalis contaminated primary root canals. Materials and methods Forty-nine single-rooted human primary teeth were reduced up to cemento-enamel junction and biomechanically prepared. After sterilization, five teeth were selected as negative controls and remaining teeth were inoculated with E. faecalis. The teeth were then randomly divided into four groups. The first group was irradiated with diode laser, the second group was irrigated with sodium hypochlorite, and the third group with triphala solution. The fourth group served as the positive control. The antimicrobial efficacy was tested by collecting transfer fluid saline from the canals and counting the colony forming units (CFUs) of viable E. faecalis on agar plates. The Mann-Whitney test was used to analyze the results, using Statistical Package for the Social Sciences software version 19. Results The results showed that mean bacterial CFU were 8.00 ± 7.87 for laser, 58.60 ± 16.63 for triphala, and 69.80 ± 19.57 for NaOCl. Laser group showed significant reduction in the colony count compared to the other groups. Triphala group showed better antibacterial activity than NaOCl, but the difference was not statistically significant. Conclusion Laser was most effective against E. faecalis and triphala can be used as an alternative disinfectant to NaOCl in primary root canals. How to cite this article Thomas S, Asokan S, John B, Priya G, Kumar S. Comparison of Antimicrobial Efficacy of Diode Laser, Triphala, and Sodium Hypochlorite in Primary Root Canals: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2017;10(1):14-17. PMID:28377648

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

PubMed Central

2011-01-01

Background Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. Methods We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. Results There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions. Trial Registration ClinicalTrials.gov Identifier NCT01286324 PMID:21939549

Effects of water fluoridation on caries experience in the primary dentition in a high caries risk community in Queensland, Australia.

PubMed

Koh, Rongzhen; Pukallus, Margaret L; Newman, Bruce; Foley, Michael; Walsh, Laurence J; Seow, W Kim

2015-01-01

In December 2008, artificial water fluoridation was introduced for the first time to the Logan-Beaudesert district in the state of Queensland, Australia. The aim of this study was to evaluate the effects of water fluoridation in the primary dentition in this community after a period of 36 months. Children aged 4-9 years with clinical examinations and bitewing radiographs (BWs) taken before water fluoridation (pre-F) were randomly selected as comparison controls for age matched children who had been exposed to a mean period of 36 months of water fluoridation (post-F). A total of 201 sets of pre-F BWs from children (mean age 6.95 ± 1.05 years) and 256 sets of post-F BWs from children (mean age 7.19 ± 1.23 years) attending schools in the district were randomly selected. Caries experience in the primary dentition was determined as decayed, missing or filled teeth/surfaces (dmft/dmfs). The caries prevalence for the pre-F group was 87% compared to 75% in the post-F group (Odds ratio (OR): 0.44, 95% CI: 0.27-0.72). Overall, there was a 19 percent reduction of mean dmft from 4.54 in the pre-F group to 3.66 in the post-F group (p = 0.005). After fluoridation, the dmfs was reduced from 6.68 to 5.17 (p = 0.0056). The distal surfaces of maxillary first primary molars experienced the greatest reduction (26%) in caries experience after water fluoridation (p < 0.001). After only 36 months of water fluoridation there was a significant drop in caries prevalence from 87 to 75% and a 19% reduction in caries experience in a community with one of the highest caries rates in Australia.

Predictors of Primary Care Physicians’ Self-reported Intention to Conduct Suicide Risk Assessments

PubMed Central

Epstein, Steven A.; Weinfurt, Kevin P.; DeCoster, Jamie; Qu, Lixin; Hannah, Natalie J.

2013-01-01

Primary care physicians play a significant role in depression care, suicide assessment, and suicide prevention. However, little is known about what factors relate to and predict quality of depression care (assessment, diagnosis, and treatment), including suicide assessment. The authors explored the extent to which select patient and physician factors increase the probability of one element of quality of care: namely, intention to conduct suicide assessment. Data were collected from 404 randomly selected primary care physicians after their interaction with CD-ROM vignettes of actors portraying major depression with moderate levels of severity. The authors examined which patient factors and physician factors increase the likelihood of physicians’ intention to conduct a suicide assessment. Data from the study revealed that physician-participants inquired about suicide 36% of the time. A random effects logistic model indicated that several factors were predictive of physicians’ intention to conduct a suicide assessment: patient’s comorbidity status (odds ratio (OR) = 0.61; 95% confidence interval (CI) = 0.37–1.00), physicians’ age (OR = 0.67; 95% CI = 0.49–0.92), physicians’ race (OR = 1.84; 95% CI = 1.08–3.13), and how depressed the physician perceived the virtual patient to be (OR = 0.58; 95% CI = 0.39–0.87). A substantial number of primary care physicians in this study indicated they would not assess for suicide, even though most physicians perceived the virtual patient to be depressed or very depressed. Further study is needed to establish factors that may be modified and targeted to increase the likelihood of physicians’ providing one element of quality of care—suicide assessment—for depressed patients. PMID:22218814

Prevalence of head lice infestation and pediculicidal effect of permethrine shampoo in primary school girls in a low-income area in southeast of Iran.

PubMed

Soleimani-Ahmadi, Moussa; Jaberhashemi, Seyed Aghil; Zare, Mehdi; Sanei-Dehkordi, Alireza

2017-07-24

Head lice infestation is a common public health problem that is most prevalent in primary school children throughout the world, especially in developing countries including different parts of Iran. This study aimed to determine the prevalence and risk factors associated with head lice infestation and pediculicidal effect of 1% permethrin shampoo in primary schools girls of Bashagard County, one of the low socioeconomic areas in southeast of Iran. In this interventional study six villages with similar demographical situations were selected and randomly assigned into intervention and control areas. In each area 150 girl students aged 7-12 years were selected randomly and screened for head lice infestation by visual scalp examination. In intervention area, treatment efficacy of 1% permethrin shampoo was evaluated via re-examination for infestation after one, two, and three weeks. Pre-tested structured questionnaire was used to collect data on socio-demographic and associated factors of head lice infestation. The prevalence of head lice infestation was 67.3%. There was significant association between head lice infestation and school grade, family size, parents' literacy, bathing facilities, frequency of hair washing, and use of shared articles (p < 0.05). The effectiveness of 1% permethrin shampoo for head lice treatment was 29.2, 68.9, and 90.3% after the first, second, and third weeks, respectively. The head lice infestation is a health problem in primary school girls of Bashagard County. Improvement of socioeconomic status and providing appropriate educational programs about head lice risk factors and prevention can be effective for reduction of infestation in this area. This trial has been registered and approved by Hormozgan University of Medical Sciences ethical committee (Trial No.764). Trial registration date: March 17 2014.

A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma patients (REACT-2)

PubMed Central

2012-01-01

Background Computed tomography (CT) scanning has become essential in the early diagnostic phase of trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT scanners and infrastructural improvements made total-body CT scanning technically feasible and its usage is currently becoming common practice in several trauma centers. However, literature provides limited evidence whether immediate total-body CT leads to better clinical outcome then conventional radiographic imaging supplemented with selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the value of immediate total-body CT scanning in trauma patients. Methods/design The REACT-2 trial is an international, multicenter randomized clinical trial. All participating trauma centers have a multi-slice CT scanner located in the trauma room or at the Emergency Department (ED). All adult, non-pregnant, severely injured trauma patients according to predefined criteria will be included. Patients in whom direct scanning will hamper necessary cardiopulmonary resuscitation or who require an immediate operation because of imminent death (both as judged by the trauma team leader) are excluded. Randomization will be computer assisted. The intervention group will receive a contrast-enhanced total-body CT scan (head to pelvis) during the primary survey. The control group will be evaluated according to local conventional trauma imaging protocols (based on ATLS guidelines) supplemented with selective CT scanning. Primary outcome will be in-hospital mortality. Secondary outcomes are differences in mortality and morbidity during the first year post trauma, several trauma work-up time intervals, radiation exposure, general health and quality of life at 6 and 12 months post trauma and cost-effectiveness. Discussion The REACT-2 trial is a multicenter randomized clinical trial that will provide evidence on the value of immediate total-body CT scanning during the primary survey of severely injured trauma patients. If immediate total-body CT scanning is found to be the best imaging strategy in severely injured trauma patients it could replace conventional imaging supplemented with CT in this specific group. Trial Registration ClinicalTrials.gov: (NCT01523626). PMID:22458247

Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer.

PubMed

Bell, R; Brown, J; Parmar, M; Toi, M; Suter, T; Steger, G G; Pivot, X; Mackey, J; Jackisch, C; Dent, R; Hall, P; Xu, N; Morales, L; Provencher, L; Hegg, R; Vanlemmens, L; Kirsch, A; Schneeweiss, A; Masuda, N; Overkamp, F; Cameron, D

2017-04-01

The purpose of this analysis was to assess the long-term impact of adding bevacizumab to adjuvant chemotherapy for early triple-negative breast cancer (TNBC). Patients eligible for the open-label randomized phase III BEATRICE trial had centrally confirmed triple-negative operable primary invasive breast cancer (pT1a-pT3). Investigators selected anthracycline- and/or taxane-based chemotherapy for each patient. After definitive surgery, patients were randomized 1:1 to receive ≥4 cycles of chemotherapy alone or with 1 year of bevacizumab (5 mg/kg/week equivalent). Stratification factors were nodal status, selected chemotherapy, hormone receptor status, and type of surgery. The primary end point was invasive disease-free survival (IDFS; previously reported). Secondary outcome measures included overall survival (OS) and safety. After 56 months' median follow-up, 293 of 2591 randomized patients had died. There was no statistically significant difference in OS between treatment arms in either the total population (hazard ratio 0.93, 95% confidence interval [CI] 0.74-1.17; P = 0.52) or pre-specified subgroups. The 5-year OS rate was 88% (95% CI 86-90%) in both treatment arms. Updated IDFS results were consistent with the primary IDFS analysis. Five-year IDFS rates were 77% (95% CI 75-79%) with chemotherapy alone versus 80% (95% CI 77-82%) with bevacizumab. From 18 months after first study dose to study end, new grade ≥3 adverse events occurred in 4.6% and 4.5% of patients in the two arms, respectively. Final OS results showed no significant benefit from bevacizumab therapy for early TNBC. Late-onset toxicities were rare in both groups. Five-year OS and IDFS rates suggest that the prognosis for patients with TNBC is better than previously thought. NCT00528567. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Comparison of periodontal ligament injection and inferior alveolar nerve block in mandibular primary molars pulpotomy: a randomized control trial.

PubMed

Haghgoo, Roza; Taleghani, Ferial

2015-05-01

Inferior alveolar nerve block is a common technique for anesthesia of the primary mandibular molars. A number of disadvantages have been shown to be associated with this technique. Periodontal ligament (PDL) injection could be considered as an alternative to inferior alveolar nerve block. The aim of this study was to evaluate the effectiveness of PDL injection in the anesthesia of primary molar pulpotomy with mandibular block. This study was performed using a sequential double-blind randomized trial design. 80 children aged 3-7 years old who required pulpotomy in symmetrical mandibular primary molars were selected. The teeth of these children were anesthetized with periodontal injection on one side of the mandible and block on the other. Pulpotomy was performed on each patient during the same appointment. Signs of discomfort, including hand and body tension and eye movement, the verbal complaint and crying (SEM scale), were evaluated by a dental assistant who was blinded to the treatment allocation of the patients. Finally, the data were analyzed using the exact Fisher test and Pearson Chi-squared exact test. Success rate was 88/75 and 91/25 in the PDL injection and nerve block groups, respectively. There was no statistically significant difference between the two techniques (P = 0.250). Results showed that PDL injection can be used as an alternative to nerve block in pulpotomy of the mandibular primary molars.

The Effectiveness of the "Lions Quest Program: Skills for Growing" on School Climate, Students' Behaviors, Perceptions of School, and Conflict Resolution Skills

ERIC Educational Resources Information Center

Gol-Guven, Mine

2017-01-01

This study examines the effectiveness of the Lions Quest Program: Skills for Growing by employing a quasi-experimental design with a control group. The experimental and control group each comprises two primary schools--one public, one private. One classroom at each grade level, 1 through 4, in each school was selected by random sampling for a…

An Assessment of Farmers' Willingness to Pay for Extension Services Using the Contingent Valuation Method (CVM): The Case of Oyo State, Nigeria

ERIC Educational Resources Information Center

Ajayi, A. O.

2006-01-01

This study assessed farmers' willingness to pay (WTP) for extension services. The Contingent Valuation Method (CVM) was used to assess the amount which farmers are willing to pay. Primary data on the demographic, socio-economic variables of farmers and their WTP were collected from 228 farmers selected randomly in a stage-wise sampling procedure…

Cost-effectiveness of a primary care treatment program for depression in low-income women in Santiago, Chile.

PubMed

Araya, Ricardo; Flynn, Terry; Rojas, Graciela; Fritsch, Rosemarie; Simon, Greg

2006-08-01

The authors compared the incremental cost-effectiveness of a stepped-care, multicomponent program with usual care for the treatment of depressed women in primary care in Santiago, Chile. A cost-effectiveness study was conducted of a previous randomized controlled trial involving 240 eligible women with DSM-IV major depression who were selected from a consecutive sample of adult women attending primary care clinics. The patients were randomly allocated to usual care or a multicomponent stepped-care program led by a nonmedical health care worker. Depression-free days and health care costs derived from local sources were assessed after 3 and 6 months. A health service perspective was used in the economic analysis. Complete data were determined for 80% of the randomly assigned patients. After we adjusted for initial severity, women receiving the stepped-care program had a mean of 50 additional depression-free days over 6 months relative to patients allocated to usual care. The stepped-care program was marginally more expensive than usual care (an extra 216 Chilean pesos per depression-free day). There was a 90% probability that the incremental cost of obtaining an extra depression-free day with the intervention would not exceed 300 pesos (1.04 US dollars). The stepped-care program was significantly more effective and marginally more expensive than usual care for the treatment of depressed women in primary care. Small investments to improve depression appear to yield larger gains in poorer environments. Simple and inexpensive treatment programs tested in developing countries might provide good study models for developed countries.

Early Brain Damage and the Development of Motor Behavior in Children: Clues for Therapeutic Intervention?

PubMed Central

Hadders-Algra, Mijna

2001-01-01

The Neuronal Group Selection Theory (NGST) could offer new insights into the mechanisms directing motor disorders, such as cerebral palsy and developmental coordination disorder. According to NGST, normal motor development is characterized by two phases of variability. Variation is not at random but determined by criteria set by genetic information. Development starts with the phase of primary variability,during which variation in motor behavior is not geared to external conditions. At function-specific ages secondary variability starts, during which motor performance can be adapted to specific situations. In both forms, of variability, selection on the basis of afferent information plays a significant role. From the NGST point of view, children with pre- or perinatally acquired brain damage, such as children with cerebral palsy and part of the children with developmental coordination disorder, suffer from stereotyped motor behavior, produced by a limited repertoire or primary (sub)cortical neuronal networks. These children also have roblems in selecting the most efficient neuronal activity, due to deficits in the processing of sensory information. Therefore, NGST suggests that intervention in these children at early age should aim at an enlargement of the primary neuronal networks. With increasing age, the emphasis of intervention could shift to the provision of ample opportunities for active practice, which might form a compensation for the impaired selection. PMID:11530887

[Renal denervation in refractory hypertension: joint statement of the German hypertension league DHL eV and the German societies of cardiology, angiology, nephrology and radiology].

PubMed

Vonend, Oliver; Böhm, Michael; Eckert, Siegfried; Hausberg, Martin; Rittger, Harald; Rump, Lars-Christian; Schmieder, Roland; Schulte, Karl-Ludwig; Schunkert, Heribert; Uder, Michael; Veelken, Roland; Vorwerk, Dierk; Weil, Joachim; Wenzel, Ulrich; Mahfoud, Felix

2015-03-01

Arterial hypertension is a major risk factor for cardiovascular mortality and remains insufficiently controlled in Germany. The sham controlled Symplicity HTN-3 trial did meet its primary safety endpoint but failed to meet its primary efficacy endpoint. Renal denervation can not replace established, well-proven therapies. It can only be used in selected truly resistant hypertensive patients as an additive approach and should be performed by specialized centers only. Randomized controlled trials are needed to further evaluate renal denervation. © Georg Thieme Verlag KG Stuttgart · New York.

Physician Surveys to Assess Customary Care in Medical Malpractice Cases

PubMed Central

Hartz, Arthur; Lucas, Joshua; Cramm, Timothy; Green, Michael; Bentler, Suzanne; Ely, John; Wolfe, Steven; James, Paul

2002-01-01

OBJECTIVE Physician experts hired and prepared by the litigants provide most information on standard of care for medical malpractice cases. Since this information may not be objective or accurate, we examined the feasibility and potential value of surveying community physicians to assess standard of care. DESIGN Seven physician surveys of mutually exclusive groups of randomly selected physicians. SETTING Iowa. PARTICIPANTS Community and academic primary care physicians and relevant specialists. INTERVENTIONS Included in each survey was a case vignette of a primary care malpractice case and key quotes from medical experts on each side of the case. Surveyed physicians were asked whether the patient should have been referred to a specialist for additional evaluation. The 7 case vignettes included 3 closed medical malpractice cases, 3 modifications of these cases, and 1 active case. MEASUREMENTS AND MAIN RESULTS Sixty-three percent of 350 community primary care physicians and 51% of 216 community specialists completed the questionnaire. For 3 closed cases, 47%, 78%, and 88% of primary care physician respondents reported that they would have made a different referral decision than the defendant. Referral percentages were minimally affected by modifying patient outcome but substantially changed by modifying patient presentation. Most physicians, even those whose referral decisions were unusual, assumed that other physicians would make similar referral decisions. For each case, at least 65% of the primary care physicians disagreed with the testimony of one of the expert witnesses. In the active case, the response rate was high (71%), and the respondents did not withhold criticism of the defendant doctor. CONCLUSIONS Randomly selected peer physicians are willing to participate in surveys of medical malpractice cases. The surveys can be used to construct the distribution of physician self-reported practice relevant to a particular malpractice case. This distribution may provide more information about customary practice or standard of care than the opinion of a single physician expert. PMID:12133145

China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China

PubMed Central

Gao, Peng; Zhao, Zhenwei; Wang, Daming; Wu, Jian; Cai, Yiling; Li, Tianxiao; Wu, Wei; Shi, Huaizhang; He, Weiwen; Zhu, Fengshui; Ling, Feng

2015-01-01

Background Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria. Methods The China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. It recruits patients with recent TIA or stroke caused by 70%–99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. Conclusion In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high-volume centers. PMID:25934656

Rationale and protocol of the Study Of diabetic Nephropathy with AtRasentan (SONAR) trial: A clinical trial design novel to diabetic nephropathy

PubMed Central

Heerspink, Hiddo J. L.; Andress, Dennis L.; Bakris, George; Brennan, John J.; Correa‐Rotter, Ricardo; Dey, Jyotirmoy; Hou, Fan Fan; Kitzman, Dalane W.; Kohan, Donald; Makino, Hirofumi; McMurray, John; Perkovic, Vlado; Tobe, Sheldon; Wigderson, Melissa; Parving, Hans‐Henrik

2018-01-01

Aims Individuals with diabetes and chronic kidney disease (CKD) are at high risk for renal events. Recent trials of novel treatments have been negative, possibly because of variability in response to treatment of the target risk factor. Atrasentan is a selective endothelin A receptor antagonist that reduces urinary albumin‐to‐creatinine ratio (UACR), with a large variability between patients. We are assessing its effect on renal outcomes in the Study Of diabetic Nephropathy with AtRasentan (SONAR; NCT01858532) with an enrichment design (>30% lowering of albuminuria) to select patients most likely to benefit. Materials and Methods SONAR is a randomized, double‐blind, placebo‐controlled trial with approximately 3500 participants who have stage 2–4 CKD and macroalbuminuria and are receiving a maximum tolerated dose of a renin‐angiotensin system inhibitor. Results After 6 weeks of exposure to atrasentan 0.75 mg once daily (enrichment period), participants with ≥30% UACR decrease and no tolerability issues (responders) were randomly assigned to placebo or atrasentan 0.75 mg/day. The responder group will be used for primary efficacy and safety analyses. Approximately 1000 participants with <30% UACR reduction (non‐responders) were also randomized to placebo or atrasentan. The primary endpoint is a composite of a sustained doubling of serum creatinine or end‐stage renal disease. The original power calculation indicated that a total of 425 primary renal events in the responder group provides 90% power to detect a 27% reduction in relative risk (alpha level of .05). Conclusion SONAR aims to determine whether atrasentan added to guideline‐recommended therapies safely reduces the risk of CKD progression and delays the onset of end‐stage renal disease in patients with type 2 diabetes and nephropathy. SONAR also aims to establish whether the enrichment of patients based on their initial “surrogate” response to atrasentan will deliver a trial design in accord with personalized treatment of diabetic kidney disease. PMID:29405626

Application of a haematopoetic progenitor cell-targeted adeno-associated viral (AAV) vector established by selection of an AAV random peptide library on a leukaemia cell line

PubMed Central

Stiefelhagen, Marius; Sellner, Leopold; Kleinschmidt, Jürgen A; Jauch, Anna; Laufs, Stephanie; Wenz, Frederik; Zeller, W Jens; Fruehauf, Stefan; Veldwijk, Marlon R

2008-01-01

Background For many promising target cells (e.g.: haematopoeitic progenitors), the susceptibility to standard adeno-associated viral (AAV) vectors is low. Advancements in vector development now allows the generation of target cell-selected AAV capsid mutants. Methods To determine its suitability, the method was applied on a chronic myelogenous leukaemia (CML) cell line (K562) to obtain a CML-targeted vector and the resulting vectors tested on leukaemia, non-leukaemia, primary human CML and CD34+ peripheral blood progenitor cells (PBPC); standard AAV2 and a random capsid mutant vector served as controls. Results Transduction of CML (BV173, EM3, K562 and Lama84) and AML (HL60 and KG1a) cell lines with the capsid mutants resulted in an up to 36-fold increase in CML transduction efficiency (K562: 2-fold, 60% ± 2% green fluorescent protein (GFP)+ cells; BV173: 9-fold, 37% ± 2% GFP+ cells; Lama84: 36-fold, 29% ± 2% GFP+ cells) compared to controls. For AML (KG1a, HL60) and one CML cell line (EM3), no significant transduction (<1% GFP+ cells) was observed for any vector. Although the capsid mutant clone was established on a cell line, proof-of-principle experiments using primary human cells were performed. For CML (3.2-fold, mutant: 1.75% ± 0.45% GFP+ cells, p = 0.03) and PBPC (3.5-fold, mutant: 4.21% ± 3.40% GFP+ cells) a moderate increase in gene transfer of the capsid mutant compared to control vectors was observed. Conclusion Using an AAV random peptide library on a CML cell line, we were able to generate a capsid mutant, which transduced CML cell lines and primary human haematopoietic progenitor cells with higher efficiency than standard recombinant AAV vectors. PMID:18789140

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

PubMed

Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

2013-11-20

Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95% CI: $16 to $44) per additional action met. A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner.

Effects of one versus two bouts of moderate intensity physical activity on selective attention during a school morning in Dutch primary schoolchildren: A randomized controlled trial.

PubMed

Altenburg, Teatske M; Chinapaw, Mai J M; Singh, Amika S

2016-10-01

Evidence suggests that physical activity is positively related to several aspects of cognitive functioning in children, among which is selective attention. To date, no information is available on the optimal frequency of physical activity on cognitive functioning in children. The current study examined the acute effects of one and two bouts of moderate-intensity physical activity on children's selective attention. Randomized controlled trial (ISRCTN97975679). Thirty boys and twenty-six girls, aged 10-13 years, were randomly assigned to three conditions: (A) sitting all morning working on simulated school tasks; (B) one 20-min physical activity bout after 90min; and (C) two 20-min physical activity bouts, i.e. at the start and after 90min. Selective attention was assessed at five time points during the morning (i.e. at baseline and after 20, 110, 130 and 220min), using the 'Sky Search' subtest of the 'Test of Selective Attention in Children'. We used GEE analysis to examine differences in Sky Search scores between the three experimental conditions, adjusting for school, baseline scores, self-reported screen time and time spent in sports. Children who performed two 20-min bouts of moderate-intensity physical activity had significantly better Sky Search scores compared to children who performed one physical activity bout or remained seated the whole morning (B=-0.26; 95% CI=[-0.52; -0.00]). Our findings support the importance of repeated physical activity during the school day for beneficial effects on selective attention in children. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Primary Care Physicians’ Evaluation and Treatment of Depression

PubMed Central

Epstein, Steven A.; Hooper, Lisa M.; Weinfurt, Kevin P.; DePuy, Venita; Cooper, Lisa A.; Harless, William G.; Tracy, Cynthia M.

2009-01-01

Little is known about how patient and primary care physician characteristics are associated with quality of depression care. The authors conducted structured interviews of 404 randomly selected primary care physicians after their interaction with CD-ROM vignettes of actors portraying depressed patients. Vignettes varied along the dimensions of medical comorbidity, attributions regarding the cause of depression, style, race/ethnicity, and gender. Results show that physicians showed wide variation in treatment decisions; for example, most did not inquire about suicidal ideation, and most did not state that they would inform the patient that there can be a delay before an antidepressant is therapeutic. Several physician characteristics were significantly associated with management decisions. Notably, physician age was inversely correlated with a number of quality-of-care measures. In conclusion, quality of care varies among primary care physicians and appears to be associated with physician characteristics to a greater extent than patient characteristics. PMID:18832109

A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF COMMUNITY-BASED DIETARY SODIUM REDUCTION – THE CHINA RURAL HEALTH INITIATIVE SODIUM REDUCTION STUDY

PubMed Central

Li, Nicole; Yan, Lijing L.; Niu, Wenyi; Labarthe, Darwin; Feng, Xiangxian; Shi, Jingpu; Zhang, Jianxin; Zhang, Ruijuan; Zhang, Yuhong; Chu, Hongling; Neiman, Andrea; Engelgau, Michael; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

2013-01-01

Background Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. Design This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24 hour urine. Trial status The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. Discussion The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide. PMID:24176436

Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT)

PubMed Central

MacDonald, Thomas M.; Hawkey, Chris J.; Ford, Ian; McMurray, John J.V.; Scheiman, James M.; Hallas, Jesper; Findlay, Evelyn; Grobbee, Diederick E.; Hobbs, F.D. Richard; Ralston, Stuart H.; Reid, David M.; Walters, Matthew R.; Webster, John; Ruschitzka, Frank; Ritchie, Lewis D.; Perez-Gutthann, Susana; Connolly, Eugene; Greenlaw, Nicola; Wilson, Adam; Wei, Li; Mackenzie, Isla S.

2017-01-01

Background Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to celecoxib vs. continuing nsNSAID therapy in a European setting. Method Patients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR). Results In total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81–1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81–1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than celecoxib, but more patients withdrew from celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P < 0.0001). Interpretation In subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed celecoxib. Clinical Trial Registration https://clinicaltrials.gov/show/NCT00447759; Unique identifier: NCT00447759. PMID:27705888

Comparing Resident Self-Report to Chart Audits for Quality Improvement Projects: Accurate Reflection or Cherry-Picking?

PubMed Central

Kuperman, Ethan F.; Tobin, Kristen; Kraschnewski, Jennifer L.

2014-01-01

Background Resident engagement in quality improvement is a requirement for graduate medical education, but the optimal means of instruction and evaluation of resident progress remain unknown. Objective To determine the accuracy of self-reported chart audits in measuring resident adherence to primary care clinical practice guidelines. Methods During the 2010–2011 academic year, second- and third-year internal medicine residents at a single, university hospital–based program performed chart audits on 10 patients from their primary care clinic to determine adherence to 16 US Preventive Services Task Force primary care guidelines. We compared residents' responses to independent audits of randomly selected patient charts by a single external reviewer. Results Self-reported data were collected by 18 second-year and 15 third-year residents for 330 patients. Independently, 70 patient charts were randomly selected for review by an external auditor. Overall guideline compliance was significantly higher on self-reported audits compared to external audits (82% versus 68%, P < .001). Of 16 guidelines, external audits found significantly lower rates of adherence for 5 (tetanus vaccination, osteoporosis screening, colon cancer screening, cholesterol screening, and obesity screening). Chlamydia screening was more common in audited charts than in self-reported data. Although third-year residents self-reported higher guideline adherence than second-year residents (86% versus 78%, P < .001), external audits for third-year residents found lower overall adherence (64% versus 72%, P  =  .040). Conclusions Residents' self-reported chart audits may significantly overestimate guideline adherence. Increased supervision and independent review appear necessary to accurately evaluate resident performance. PMID:26140117

Microbiological assessment of root canals following use of rotary and manual instruments in primary molars.

PubMed

Subramaniam, Priya; Tabrez, T A; Babu, K L Girish

2013-01-01

To assess the microflora of root canals in primary molars following use of rotary NiTi files and conventional hand NiTi and stainless steel files. This randomized clinical trial consisted of a total of 60 first and second primary molars requiring root canal treatment, who were selected from children aged 5-9 years. Based on type of root canal instrumentation, the teeth were randomly assigned to three groups of twenty teeth each; Group A: Rotary NiTi files, Group B: Hand NiTi files and Group C: Hand stainless steel files. Following administration of local anesthesia, isolation with rubber dam was carried out. For the purpose of instrumentation and sampling, the palatal canal of maxillary molars and the distal canal of mandibular molars were selected. Prior to sampling, the orifices of other canals in these teeth were sealed, so as to prevent any contamination. Instrumentation was carried out in each group using respective instruments along with intermittent saline irrigation. Root canal samples were obtained both before and after instrumentation, using sterile absorbent paper points and transferred to a sterile vial with transport fluid. Serial dilutions were prepared and cultured on suitable agar media. Both aerobic and anaerobic microbial counts were made. Data obtained was subjected to statistical analysis using Wilcoxon signed rank test and one-way Analysis of variance. In all three groups, there was a significant reduction in both aerobic and anaerobic mean microbial count following root canal instrumentation. (p < 0.001). Rotary NiTi files were as efficient as conventional hand instruments in significantly reducing the root canal microflora.

Identifying Human Papillomavirus Vaccination Practices Among Primary Care Providers of Minority, Low-Income and Immigrant Patient Populations

PubMed Central

Bruno, Denise M.; Wilson, Tracey E.; Gany, Francesca; Aragones, Abraham

2014-01-01

Objective Minority populations in the United States are disproportionally affected by Human Papillomavirus (HPV) infection and HPV-related cancer. We sought to understand physician practices, knowledge and beliefs that affect utilization of the HPV vaccine in primary care settings serving large minority populations in areas with increased rates of HPV-related cancer. Study Design Cross-sectional survey of randomly selected primary care providers, including pediatricians, family practice physicians and internists, serving large minority populations in Brooklyn, N.Y. and in areas with higher than average cervical cancer rates. Results Of 156 physicians randomly selected, 121 eligible providers responded to the survey; 64% were pediatricians, 19% were internists and 17% were family practitioners. Thirty-four percent of respondents reported that they routinely offered HPV vaccine to their eligible patients. Seventy percent of physicians reported that the lack of preventive care visits for patients in the eligible age group limited their ability to recommend the HPV vaccine and 70% of those who reported this barrier do not routinely recommend HPV vaccine. The lack of time to educate parents about the HPV vaccine and cost of the vaccine to their patients were two commonly reported barriers that affected whether providers offered the vaccine. Conclusions Our study found that the majority of providers serving the highest risk populations for HPV infection and HPV-related cancers are not routinely recommending the HPV vaccine to their patients. Reasons for providers' failure to recommend the HPV vaccine routinely are identified and possible areas for targeted interventions to increase HPV vaccination rates are discussed. PMID:24886959

Comparing Resident Self-Report to Chart Audits for Quality Improvement Projects: Accurate Reflection or Cherry-Picking?

PubMed

Kuperman, Ethan F; Tobin, Kristen; Kraschnewski, Jennifer L

2014-12-01

Resident engagement in quality improvement is a requirement for graduate medical education, but the optimal means of instruction and evaluation of resident progress remain unknown. To determine the accuracy of self-reported chart audits in measuring resident adherence to primary care clinical practice guidelines. During the 2010-2011 academic year, second- and third-year internal medicine residents at a single, university hospital-based program performed chart audits on 10 patients from their primary care clinic to determine adherence to 16 US Preventive Services Task Force primary care guidelines. We compared residents' responses to independent audits of randomly selected patient charts by a single external reviewer. Self-reported data were collected by 18 second-year and 15 third-year residents for 330 patients. Independently, 70 patient charts were randomly selected for review by an external auditor. Overall guideline compliance was significantly higher on self-reported audits compared to external audits (82% versus 68%, P < .001). Of 16 guidelines, external audits found significantly lower rates of adherence for 5 (tetanus vaccination, osteoporosis screening, colon cancer screening, cholesterol screening, and obesity screening). Chlamydia screening was more common in audited charts than in self-reported data. Although third-year residents self-reported higher guideline adherence than second-year residents (86% versus 78%, P < .001), external audits for third-year residents found lower overall adherence (64% versus 72%, P  =  .040). Residents' self-reported chart audits may significantly overestimate guideline adherence. Increased supervision and independent review appear necessary to accurately evaluate resident performance.

Salvage therapy for locally recurrent prostate cancer after radiation.

PubMed

Marcus, David M; Canter, Daniel J; Jani, Ashesh B; Dobbs, Ryan W; Schuster, David M; Carthon, Bradley C; Rossi, Peter J

2012-12-01

External beam radiotherapy (EBRT) is widely utilized as primary therapy for clinically localized prostate cancer. For patients who develop locally recurrent disease after EBRT, local salvage therapy may be indicated. The primary modalities for local salvage treatment in this setting include radical prostatectomy, cryotherapy, and brachytherapy. To date, there is little data describing outcomes and toxicity associated with each of these salvage modalities. A review of the literature was performed to identify studies of local salvage therapy for patients who had failed primary EBRT for localized prostate cancer. We focused on prospective trials and multi-institutional retrospective series in order to identify the highest level of evidence describing these therapies. The majority of reports describing the use of local salvage treatment for recurrent prostate cancer after EBRT are single-institution, retrospective reports, although small prospective studies are available for salvage cryotherapy and salvage brachytherapy. Clinical outcomes and toxicity for each modality vary widely across studies, which is likely due to the heterogeneity of patient populations, treatment techniques, and definitions of failure. In general, most studies demonstrate that local salvage therapy after EBRT may provide long-term local control in appropriately selected patients, although toxicity is often significant. As there are no randomized trials comparing salvage treatment modalities for localized prostate cancer recurrence after EBRT, the selection of a local treatment modality should be made on a patient-by-patient basis, with careful consideration of each patient's disease characteristics and tolerance for the risks of treatment. Additional data, ideally from prospective randomized trials, is needed to guide decision making for patients with local recurrence after EBRT failure.

Effect of an obesity best practice alert on physician documentation and referral practices.

PubMed

Fitzpatrick, Stephanie L; Dickins, Kirsten; Avery, Elizabeth; Ventrelle, Jennifer; Shultz, Aaron; Kishen, Ekta; Rothschild, Steven

2017-12-01

The Centers for Medicare & Medicaid Services Electronic Health Record Meaningful Use Incentive Program requires physicians to document body mass index (BMI) and a follow-up treatment plan for adult patients with BMI ≥ 25. To examine the effect of a best practice alert on physician documentation of obesity-related care and referrals to weight management treatment, in a cluster-randomized design, 14 primary care clinics at an academic medical center were randomized to best practice alert intervention (n = 7) or comparator (n = 7). The alert was triggered when both height and weight were entered and BMI was ≥30. Both intervention and comparator clinics could document meaningful use by selecting a nutrition education handout within the alert. Intervention clinics could also select a referral option from the list of clinic and community-based weight management programs embedded in the alert. Main outcomes were proportion of eligible patients with (1) obesity-related documentation and (2) referral. There were 26,471 total primary care encounters with 12,981 unique adult patients with BMI ≥ 30 during the 6-month study period. Documentation doubled (17 to 33%) with implementation of the alert. However, intervention clinics were not significantly more likely to refer patients to weight management than comparator clinics (2.8 vs. 1.3%, p = 0.07). Although the alert was associated with increased physician meaningful use compliance, it was not an effective strategy for improving patient access to weight management services. Further research is needed to understand system-level characteristics that influence obesity management in primary care.

Valuing Equal Protection in Aviation Security Screening.

PubMed

Nguyen, Kenneth D; Rosoff, Heather; John, Richard S

2017-12-01

The growing number of anti-terrorism policies has elevated public concerns about discrimination. Within the context of airport security screening, the current study examines how American travelers value the principle of equal protection by quantifying the "equity premium" that they are willing to sacrifice to avoid screening procedures that result in differential treatments. In addition, we applied the notion of procedural justice to explore the effect of alternative selective screening procedures on the value of equal protection. Two-hundred and twenty-two respondents were randomly assigned to one of three selective screening procedures: (1) randomly, (2) using behavioral indicators, or (3) based on demographic characteristics. They were asked to choose between airlines using either an equal or a discriminatory screening procedure. While the former requires all passengers to be screened in the same manner, the latter mandates all passengers undergo a quick primary screening and, in addition, some passengers are selected for a secondary screening based on a predetermined selection criterion. Equity premiums were quantified in terms of monetary cost, wait time, convenience, and safety compromise. Results show that equity premiums varied greatly across respondents, with many indicating little willingness to sacrifice to avoid inequitable screening, and a smaller minority willing to sacrifice anything to avoid the discriminatory screening. The selective screening manipulation was effective in that equity premiums were greater under selection by demographic characteristics compared to the other two procedures. © 2017 Society for Risk Analysis.

Cheating Tendency in Examinations among Secondary School Students in Nigeria: A Case Study of Schools in the Odukpani Local Government Area, Cross River State

ERIC Educational Resources Information Center

Bisong, Nonso Ngozika; Akpama, Felicia; Edet, Pauline B.

2009-01-01

This study is designed to examine cheating tendency among secondary school students in Nigeria, with evidence from schools in the Odukpani Local Government Area of Cross River State. A total of 331 respondents in Senior Secondary 3 classes were randomly selected from 10 post-primary schools in the area. A survey questionnaire was used to elicit…

Text-messaging versus telephone reminders to reduce missed appointments in an academic primary care clinic: a randomized controlled trial

PubMed Central

2013-01-01

Background Telephone or text-message reminders have been shown to significantly reduce the rate of missed appointments in different medical settings. Since text-messaging is less resource-demanding, we tested the hypothesis that text-message reminders would be as effective as telephone reminders in an academic primary care clinic. Methods A randomized controlled non-inferiority trial was conducted in the academic primary care division of the Geneva University Hospitals between November 2010 and April 2011. Patients registered for an appointment at the clinic, and for whom a cell phone number was available, were randomly selected to receive a text-message or a telephone call reminder 24 hours before the planned appointment. Patients were included each time they had an appointment. The main outcome was the rate of unexplained missed appointments. Appointments were not missed if they were cancelled or re-scheduled before or independently from the intervention. We defined non-inferiority as a difference below 2% in the rate of missed appointments and powered the study accordingly. A satisfaction survey was conducted among a random sample of 900 patients (response rate 41%). Results 6450 patients were included, 3285 in the text-message group and 3165 in the telephone group. The rate of missed appointments was similar in the text-message group (11.7%, 95% CI: 10.6-12.8) and in the telephone group (10.2%, 95% CI: 9.2-11.3 p = 0.07). However, only text message reminders were cost-effective. No patient reported any disturbance by any type of reminder in the satisfaction survey. Three quarters of surveyed patients recommended its regular implementation in the clinic. Conclusions Text-message reminders are equivalent to telephone reminders in reducing the proportion of missed appointments in an academic primary care clinic and are more cost-effective. Both types of reminders are well accepted by patients. PMID:23557331

"Open mesh" or "strictly selected population" recruitment? The experience of the randomized controlled MeMeMe trial.

PubMed

Cortellini, Mauro; Berrino, Franco; Pasanisi, Patrizia

2017-01-01

Among randomized controlled trials (RCTs), trials for primary prevention require large samples and long follow-up to obtain a high-quality outcome; therefore the recruitment process and the drop-out rates largely dictate the adequacy of the results. We are conducting a Phase III trial on persons with metabolic syndrome to test the hypothesis that comprehensive lifestyle changes and/or metformin treatment prevents age-related chronic diseases (the MeMeMe trial, EudraCT number: 2012-005427-32, also registered on ClinicalTrials.gov [NCT02960711]). Here, we briefly analyze and discuss the reasons which may lead to participants dropping out from trials. In our experience, participants may back out of a trial for different reasons. Drug-induced side effects are certainly the most compelling reason. But what are the other reasons, relating to the participants' perception of the progress of the trial which led them to withdraw after randomization? What about the time-dependent drop-out rate in primary prevention trials? The primary outcome of this analysis is the point of drop-out from trial, defined as the time from the randomization date to the withdrawal date. Survival functions were non-parametrically estimated using the product-limit estimator. The curves were statistically compared using the log-rank test ( P =0.64, not significant). Researchers involved in primary prevention RCTs seem to have to deal with the paradox of the proverbial "short blanket syndrome". Recruiting only highly motivated candidates might be useful for the smooth progress of the trial but it may lead to a very low enrollment rate. On the other hand, what about enrolling all the eligible subjects without considering their motivation? This might boost the enrollment rate, but it can lead to biased results on account of large proportions of drop-outs. Our experience suggests that participants do not change their mind depending on the allocation group (intervention or control). There is no single answer to sort out the short blanket syndrome.

A focus group study to understand biases and confounders in a cluster randomized controlled trial on low back pain in primary care in Norway.

PubMed

Werner, Erik L; Løchting, Ida; Storheim, Kjersti; Grotle, Margreth

2018-05-22

Cluster randomized controlled trials are often used in research in primary care but creates challenges regarding biases and confounders. We recently presented a study on low back pain from primary care in Norway with equal effects in the intervention and the control group. In order to understand the specific mechanisms that may produce biases in a cluster randomized trial we conducted a focus group study among the participating health care providers. The aim of this study was to understand how the participating providers themselves influenced on the study and thereby possibly on the results of the cluster randomized controlled trial. The providers were invited to share their experiences from their participation in the COPE study, from recruitment of patients to accomplishment of either the intervention or control consultations. Six clinicians from the intervention group and four from the control group took part in the focus group interviews. The group discussions focused on feasibility of the study in primary care and particularly on identifying potential biases and confounders in the study. The audio-recorded interviews were transcribed verbatim and analyzed according to a systematic text condensation. The themes for the analysis emerged from the group discussions. A personal interest for back pain, logistic factors at the clinics and an assessment of the patients' capacity to accomplish the study prior to their recruitment was reported. The providers were allowed to provide additional therapy to the intervention and it turned out that some of these could be regarded as opposed to the messages of the intervention. The providers seemed to select different items from the educational package according to personal beliefs and their perception of the patients' acceptance. The study disclosed several potential biases to the COPE study which may have impacted on the study results. Awareness of these is highly important when planning and conducting a cluster randomized controlled trial. Procedures in the recruitment of both providers and patients seem to be key factors and the providers should be aware of their role in a scientific study in order to standardize the provision of the intervention.

Effect of mirtazapine versus selective serotonin reuptake inhibitors on benzodiazepine use in patients with major depressive disorder: a pragmatic, multicenter, open-label, randomized, active-controlled, 24-week trial.

PubMed

Hashimoto, Tasuku; Shiina, Akihiro; Hasegawa, Tadashi; Kimura, Hiroshi; Oda, Yasunori; Niitsu, Tomihisa; Ishikawa, Masatomo; Tachibana, Masumi; Muneoka, Katsumasa; Matsuki, Satoshi; Nakazato, Michiko; Iyo, Masaomi

2016-01-01

This study aimed to evaluate whether selecting mirtazapine as the first choice for current depressive episode instead of selective serotonin reuptake inhibitors (SSRIs) reduces benzodiazepine use in patients with major depressive disorder (MDD). We concurrently examined the relationship between clinical responses and serum mature brain-derived neurotrophic factor (BDNF) and its precursor, proBDNF. We conducted an open-label randomized trial in routine psychiatric practice settings. Seventy-seven MDD outpatients were randomly assigned to the mirtazapine or predetermined SSRIs groups, and investigators arbitrarily selected sertraline or paroxetine. The primary outcome was the proportion of benzodiazepine users at weeks 6, 12, and 24 between the groups. We defined patients showing a ≥50 % reduction in Hamilton depression rating scale (HDRS) scores from baseline as responders. Blood samples were collected at baseline, weeks 6, 12, and 24. Sixty-five patients prescribed benzodiazepines from prescription day 1 were analyzed for the primary outcome. The percentage of benzodiazepine users was significantly lower in the mirtazapine than in the SSRIs group at weeks 6, 12, and 24 (21.4 vs. 81.8 %; 11.1 vs. 85.7 %, both P  < 0.001; and 12.5 vs. 81.8 %, P  = 0.0011, respectively). No between-group difference was observed in HDRS score changes. Serum proBDNF levels were significantly decreased ( χ 2  = 8.5, df  = 3, P  = 0.036) and serum mature BDNF levels were temporarily significantly decreased ( F  = 3.5, df  = 2.4, P  = 0.027) in the responders of both groups at week 24. This study demonstrated mirtazapine as the first-choice antidepressant for current depressive episodes may reduce benzodiazepine use in patients with MDD. Trial registration UMIN000004144. Registered 2nd September 2010. The date of enrolment of the first participant to the trial was 24th August 2010. This study was retrospectively registered 9 days after the first participant was enrolled.

Estimating the price elasticity of beer: meta-analysis of data with heterogeneity, dependence, and publication bias.

PubMed

Nelson, Jon P

2014-01-01

Precise estimates of price elasticities are important for alcohol tax policy. Using meta-analysis, this paper corrects average beer elasticities for heterogeneity, dependence, and publication selection bias. A sample of 191 estimates is obtained from 114 primary studies. Simple and weighted means are reported. Dependence is addressed by restricting number of estimates per study, author-restricted samples, and author-specific variables. Publication bias is addressed using funnel graph, trim-and-fill, and Egger's intercept model. Heterogeneity and selection bias are examined jointly in meta-regressions containing moderator variables for econometric methodology, primary data, and precision of estimates. Results for fixed- and random-effects regressions are reported. Country-specific effects and sample time periods are unimportant, but several methodology variables help explain the dispersion of estimates. In models that correct for selection bias and heterogeneity, the average beer price elasticity is about -0.20, which is less elastic by 50% compared to values commonly used in alcohol tax policy simulations. Copyright © 2013 Elsevier B.V. All rights reserved.

Implantable cardioverter defibrillators for primary prevention in patients with nonischemic cardiomyopathy: A systematic review and meta-analysis.

PubMed

Akel, Tamer; Lafferty, James

2017-06-01

Implantable cardioverter defibrillators (ICDs) have proved their favorable outcomes on survival in selected patients with cardiomyopathy. Although previous meta-analyses have shown benefit for their use in primary prevention, the evidence remains less robust for patients with nonischemic cardiomyopathy (NICM) in comparison to patients with coronary artery disease (CAD). To evaluate the effect of ICD therapy on reducing all-cause mortality and sudden cardiac death (SCD) in patients with NICM. PubMed (1993-2016), the Cochrane Central Register of Controlled Trials (2000-2016), reference lists of relevant articles, and previous meta-analyses. Search terms included defibrillator, heart failure, cardiomyopathy, randomized controlled trials, and clinical trials. Eligible trials were randomized controlled trials with at least an arm of ICD, an arm of medical therapy and enrolled some patients with NICM. The primary endpoint in the trials should include all-cause mortality or mortality from SCD. Hazard ratios (HRs) for all-cause mortality and mortality from SCD were either extracted or calculated along with their standard errors. Of the 1047 abstracts retained by the initial screen, eight randomized controlled trials were identified. Five of these trials reported relevant data regarding patients with NICM and were subsequently included in this meta-analysis. Pooled analysis of HRs suggested a statistically significant reduction in all-cause mortality among a total of 2573 patients randomized to ICD vs medical therapy (HR 0.80; 95% CI, 0.67-0.96; P=.02). Pooled analysis of HRs for mortality from SCD was also statistically significant (n=1677) (HR 0.51; 95% CI, 0.34-0.76; P=.001). ICD implantation is beneficial in terms of all-cause mortality and mortality from SCD in certain subgroups of patients with NICM. © 2017 John Wiley & Sons Ltd.

A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity): rationale, design and methodology of a randomized controlled trial in Nanjing city, China.

PubMed

Xu, Fei; Ware, Robert S; Tse, Lap Ah; Wang, Zhiyong; Hong, Xin; Song, Aiju; Li, Jiequan; Wang, Youfa

2012-06-15

The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group). Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a) classroom curriculum, (including physical education and healthy diet education), b) school environment support, c) family involvement, and d) fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools' regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. ChiCTR-ERC-11001819.

Refining the Use of Nasal High-Flow Therapy as Primary Respiratory Support for Preterm Infants.

PubMed

Manley, Brett J; Roberts, Calum T; Frøisland, Dag H; Doyle, Lex W; Davis, Peter G; Owen, Louise S

2018-05-01

To identify clinical and demographic variables that predict nasal high-flow (nHF) treatment failure when used as a primary respiratory support for preterm infants. This secondary analysis used data from a multicenter, randomized, controlled trial comparing nHF with continuous positive airway pressure as primary respiratory support in preterm infants 28-36 completed weeks of gestation. Treatment success or failure with nHF was determined using treatment failure criteria within the first 72 hours after randomization. Infants in whom nHF treatment failed received continuous positive airway pressure, and were then intubated if failure criteria were again met. There were 278 preterm infants included, with a mean gestational age (GA) of 32.0 ± 2.1 weeks and a birth weight of 1737 ± 580 g; of these, nHF treatment failed in 71 infants (25.5%). Treatment failure was moderately predicted by a lower GA and higher prerandomization fraction of inspired oxygen (FiO 2 ): area under a receiver operating characteristic curve of 0.76 (95% CI, 0.70-0.83). Nasal HF treatment success was more likely in infants born at ≥30 weeks GA and with prerandomization FiO 2 <0.30. In preterm infants ≥28 weeks' GA enrolled in a randomized, controlled trial, lower GA and higher FiO 2 before randomization predicted early nHF treatment failure. Infants were more likely to be successfully treated with nHF from soon after birth if they were born at ≥30 weeks GA and had a prerandomization FiO 2 <0.30. However, even in this select population, continuous positive airway pressure remains superior to nHF as early respiratory support in preventing treatment failure. Australian New Zealand Clinical Trials Registry: ACTRN12613000303741. Copyright © 2018 Elsevier Inc. All rights reserved.

[Penetrant injuries of colon--our experience].

PubMed

Lazović, R; Krivokapić, Z; Dobricanin, V

2010-01-01

In attemption to determine the place of primary repair in management of colon injuries, an open, non randomized clinical study was performed. Retrospective (RS) group of 62 patients according to exclusion criteria by Stone (S/F) and Flint (F1) was managed by one or two stage surgical procedure. Prospective (PR) group of 34 patients was managed using one stage repair non-selectively: two stage procedures were performed in 3 cases of advanced peritonitis and multi-segmental lacerations with impaired circulation of colon. In RS group 36 patients were managed by primary repair and in PR group, 31 were managed by primary repair. Both groups were of similar age/sex. Indexes of trauma severity were similar (TS, ISS, PATI). The latent time was shorter in PR group. Associated injuries to other body regions and abdominal organs were similar in both groups. S/F criteria and Flint grading in both (RS vs. PR) groups were similar. Comparison of attempted and successful primary repairs justifies the more liberal use of primary repair in early management of colon injuries.

Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

PubMed

Utz, Bettina; Assarag, Bouchra; Essolbi, Amina; Barkat, Amina; El Ansari, Nawal; Fakhir, Bouchra; Delamou, Alexandre; De Brouwere, Vincent

2017-06-19

Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up. We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers. In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and treatment delays. Implementation of a strategy that enables detection, management and follow-up of affected women at primary health care level is expected to positively impact on access to care and medical outcomes. The trial has been registered on clininicaltrials.gov ; identifier NCT02979756 ; retrospectively registered 22 November 2016.

Improving Quality of Care in Primary Health-Care Facilities in Rural Nigeria

PubMed Central

Ugo, Okoli; Ezinne, Eze-Ajoku; Modupe, Oludipe; Nicole, Spieker; Kelechi, Ohiri

2016-01-01

Background: Nigeria has a high population density but a weak health-care system. To improve the quality of care, 3 organizations carried out a quality improvement pilot intervention at the primary health-care level in selected rural areas. Objective: To assess the change in quality of care in primary health-care facilities in rural Nigeria following the provision of technical governance support and to document the successes and challenges encountered. Method: A total of 6 states were selected across the 6 geopolitical zones of the country. However, assessments were carried out in 40 facilities in only 5 states. Selection was based on location, coverage, and minimum services offered. The facilities were divided randomly into 2 groups. The treatment group received quality-of-care assessment, continuous feedback, and improvement support, whereas the control group received quality assessment and no other support. Data were collected using the SafeCare Healthcare Standards and managed on the SafeCare Data Management System—AfriDB. Eight core areas were assessed at baseline and end line, and compliance to quality health-care standards was compared. Result: Outcomes from 40 facilities were accepted and analyzed. Overall scores increased in the treatment facilities compared to the control facilities, with strong evidence of improvement (t = 5.28, P = .0004) and 11% average improvement, but no clear pattern of improvement emerged in the control group. Conclusion: The study demonstrated governance support and active community involvement offered potential for quality improvement in primary health-care facilities. PMID:28462280

Improving Quality of Care in Primary Health-Care Facilities in Rural Nigeria: Successes and Challenges.

PubMed

Ugo, Okoli; Ezinne, Eze-Ajoku; Modupe, Oludipe; Nicole, Spieker; Winifred, Ekezie; Kelechi, Ohiri

2016-01-01

Nigeria has a high population density but a weak health-care system. To improve the quality of care, 3 organizations carried out a quality improvement pilot intervention at the primary health-care level in selected rural areas. To assess the change in quality of care in primary health-care facilities in rural Nigeria following the provision of technical governance support and to document the successes and challenges encountered. A total of 6 states were selected across the 6 geopolitical zones of the country. However, assessments were carried out in 40 facilities in only 5 states. Selection was based on location, coverage, and minimum services offered. The facilities were divided randomly into 2 groups. The treatment group received quality-of-care assessment, continuous feedback, and improvement support, whereas the control group received quality assessment and no other support. Data were collected using the SafeCare Healthcare Standards and managed on the SafeCare Data Management System-AfriDB. Eight core areas were assessed at baseline and end line, and compliance to quality health-care standards was compared. Outcomes from 40 facilities were accepted and analyzed. Overall scores increased in the treatment facilities compared to the control facilities, with strong evidence of improvement ( t = 5.28, P = .0004) and 11% average improvement, but no clear pattern of improvement emerged in the control group. The study demonstrated governance support and active community involvement offered potential for quality improvement in primary health-care facilities.

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease

PubMed Central

Sperling, R.; Keren, R.; Porsteinsson, A.P.; van Dyck, C.H.; Tariot, P.N.; Gilman, S.; Arnold, D.; Abushakra, S.; Hernandez, C.; Crans, G.; Liang, E.; Quinn, G.; Bairu, M.; Pastrak, A.; Cedarbaum, J.M.

2011-01-01

Objective: This randomized, double-blind, placebo-controlled, dose-ranging phase 2 study explored safety, efficacy, and biomarker effects of ELND005 (an oral amyloid anti-aggregation agent) in mild to moderate Alzheimer disease (AD). Methods: A total of 353 patients were randomized to ELND005 (250, 1,000, or 2,000 mg) or placebo twice daily for 78 weeks. Coprimary endpoints were the Neuropsychological Test Battery (NTB) and Alzheimer's Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) scale. The primary analysis compared 250 mg (n =84) to placebo (n =82) after an imbalance of infections and deaths led to early discontinuation of the 2 higher dose groups. Results: The 250 mg dose demonstrated acceptable safety. The primary efficacy analysis at 78 weeks revealed no significant differences between the treatment groups on the NTB or ADCS-ADL. Brain ventricular volume showed a small but significant increase in the overall 250 mg group (p =0.049). At the 250 mg dose, scyllo-inositol concentrations increased in CSF and brain and CSF Aβx-42 was decreased significantly compared to placebo (p =0.009). Conclusions: Primary clinical efficacy outcomes were not significant. The safety and CSF biomarker results will guide selection of the optimal dose for future studies, which will target earlier stages of AD. Classification of evidence: Due to the small sample sizes, this Class II trial provides insufficient evidence to support or refute a benefit of ELND005. PMID:21917766

Comparison of Periodontal Ligament Injection and Inferior Alveolar Nerve Block in Mandibular Primary Molars Pulpotomy: A Randomized Control Trial

PubMed Central

Haghgoo, Roza; Taleghani, Ferial

2015-01-01

Background: Inferior alveolar nerve block is a common technique for anesthesia of the primary mandibular molars. A number of disadvantages have been shown to be associated with this technique. Periodontal ligament (PDL) injection could be considered as an alternative to inferior alveolar nerve block. The aim of this study was to evaluate the effectiveness of PDL injection in the anesthesia of primary molar pulpotomy with mandibular block. Methods: This study was performed using a sequential double-blind randomized trial design. 80 children aged 3-7 years old who required pulpotomy in symmetrical mandibular primary molars were selected. The teeth of these children were anesthetized with periodontal injection on one side of the mandible and block on the other. Pulpotomy was performed on each patient during the same appointment. Signs of discomfort, including hand and body tension and eye movement, the verbal complaint and crying (SEM scale), were evaluated by a dental assistant who was blinded to the treatment allocation of the patients. Finally, the data were analyzed using the exact Fisher test and Pearson Chi-squared exact test. Results: Success rate was 88/75 and 91/25 in the PDL injection and nerve block groups, respectively. There was no statistically significant difference between the two techniques (P = 0.250). Conclusion: Results showed that PDL injection can be used as an alternative to nerve block in pulpotomy of the mandibular primary molars. PMID:26028895

Foot examinations of diabetes patients by primary health care nurses in Auckland, New Zealand.

PubMed

Daly, Barbara; Arroll, Bruce; Sheridan, Nicolette; Kenealy, Timothy; Stewart, Alistair; Scragg, Robert

2014-07-01

To identify factors associated with patients receiving foot examinations by primary health care nurses. A cross-sectional survey of 287 randomly sampled primary health care nurses, from a total of 1091 in Auckland, completed a postal self-administered questionnaire and telephone interview. Biographical and diabetes management details were collected for 265 diabetes patients consulted by the nurses on a randomly selected day. A response rate of 86% was achieved. Nurses examined patient's feet in 46% of consultations. Controlling for demographic variables, foot examinations were associated with age, odds ratio (1.25, 95% CI 0.57-2.74) for patients aged 51-65 years and >66 years (2.50, 1.08-5.75) compared with those ≤50 years, consultations by district compared with practice nurses (14.23, 95% CI 3.82-53.05), special programme consultations compared with usual follow-up consults (8.81, 95% CI 2.99-25.93) and length of consultation (1.89, 0.72-4.97) for 15-30 min and (4.45, 95% CI 1.48-13.41) >30 min compared with consultations ≤15 min, or for wound care (2.58, 1.01-6.61). Diabetes foot examinations by primary health care nurses varies greatly, and are associated with characteristics of the patient (age, need for wound care) and the consultation (district nurses, diabetes programme and duration). Copyright © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

A sampling design framework for monitoring secretive marshbirds

USGS Publications Warehouse

Johnson, D.H.; Gibbs, J.P.; Herzog, M.; Lor, S.; Niemuth, N.D.; Ribic, C.A.; Seamans, M.; Shaffer, T.L.; Shriver, W.G.; Stehman, S.V.; Thompson, W.L.

2009-01-01

A framework for a sampling plan for monitoring marshbird populations in the contiguous 48 states is proposed here. The sampling universe is the breeding habitat (i.e. wetlands) potentially used by marshbirds. Selection protocols would be implemented within each of large geographical strata, such as Bird Conservation Regions. Site selection will be done using a two-stage cluster sample. Primary sampling units (PSUs) would be land areas, such as legal townships, and would be selected by a procedure such as systematic sampling. Secondary sampling units (SSUs) will be wetlands or portions of wetlands in the PSUs. SSUs will be selected by a randomized spatially balanced procedure. For analysis, the use of a variety of methods as a means of increasing confidence in conclusions that may be reached is encouraged. Additional effort will be required to work out details and implement the plan.

Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting.

PubMed

George, Steven Z; Teyhen, Deydre S; Wu, Samuel S; Wright, Alison C; Dugan, Jessica L; Yang, Guijun; Robinson, Michael E; Childs, John D

2009-07-01

The general population has a pessimistic view of low back pain (LBP), and evidence-based information has been used to positively influence LBP beliefs in previously reported mass media studies. However, there is a lack of randomized trials investigating whether LBP beliefs can be modified in primary prevention settings. This cluster randomized clinical trial investigated the effect of an evidence-based psychosocial educational program (PSEP) on LBP beliefs for soldiers completing military training. A military setting was selected for this clinical trial, because LBP is a common cause of soldier disability. Companies of soldiers (n = 3,792) were recruited, and cluster randomized to receive a PSEP or no education (control group, CG). The PSEP consisted of an interactive seminar, and soldiers were issued the Back Book for reference material. The primary outcome measure was the back beliefs questionnaire (BBQ), which assesses inevitable consequences of and ability to cope with LBP. The BBQ was administered before randomization and 12 weeks later. A linear mixed model was fitted for the BBQ at the 12-week follow-up, and a generalized linear mixed model was fitted for the dichotomous outcomes on BBQ change of greater than two points. Sensitivity analyses were performed to account for drop out. BBQ scores (potential range: 9-45) improved significantly from baseline of 25.6 +/- 5.7 (mean +/- SD) to 26.9 +/- 6.2 for those receiving the PSEP, while there was a significant decline from 26.1 +/- 5.7 to 25.6 +/- 6.0 for those in the CG. The adjusted mean BBQ score at follow-up for those receiving the PSEP was 1.49 points higher than those in the CG (P < 0.0001). The adjusted odds ratio of BBQ improvement of greater than two points for those receiving the PSEP was 1.51 (95% CI = 1.22-1.86) times that of those in the CG. BBQ improvement was also mildly associated with race and college education. Sensitivity analyses suggested minimal influence of drop out. In conclusion, soldiers that received the PSEP had an improvement in their beliefs related to the inevitable consequences of and ability to cope with LBP. This is the first randomized trial to show positive influence on LBP beliefs in a primary prevention setting, and these findings have potentially important public health implications for prevention of LBP.

Remission in Depressed Geriatric Primary Care Patients: A Report From the PROSPECT Study

PubMed Central

Alexopoulos, George S.; Katz, Ira R.; Bruce, Martha L.; Heo, Moonseong; Have, Thomas Ten; Raue, Patrick; Bogner, Hillary R.; Schulberg, Herbert C.; Mulsant, Benoit H.; Reynolds, Charles F.

2009-01-01

Objective This study compared time to first remission for elderly depressed patients in primary care for practices that implemented a care management model versus those providing usual care. In addition, it sought to identify risk factors for nonremission that could guide treatment planning and referral to care managers or specialists. Method Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT) data were analyzed. Participants were older patients (≥60 years) selected following screening of 9,072 randomly identified primary care patients. The present analysis examined patients with major depression and a 24-item Hamilton Depression Rating Scale score of 18 or greater who were followed for at least 4 months (N=215). Primary care practices were randomly assigned to offer the PROSPECT intervention or usual care. The intervention consisted of services of trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 18 months. Results First remission occurred earlier and was more common among patients receiving the intervention than among those receiving usual care. For all patients, limitations in physical and emotional functions predicted poor remission rate. Patients experiencing hopelessness were more likely to achieve remission if treated in intervention practices. Similarly, the intervention was more effective in patients with low baseline anxiety. Conclusions Longitudinal assessment of depression, hopelessness, anxiety, and physical and emotional functional limitations in depressed older primary care patients is critical. Patients with prominent symptoms or impairment in these areas may be candidates for care management or mental health care, since they are at risk for remaining depressed and disabled. PMID:15800144

Agreement in reporting between trial publications and current clinical trial registry in high impact journals: A methodological review.

PubMed

Kosa, Sarah Daisy; Mbuagbaw, Lawrence; Borg Debono, Victoria; Bhandari, Mohit; Dennis, Brittany B; Ene, Gabrielle; Leenus, Alvin; Shi, Daniel; Thabane, Michael; Valvasori, Sara; Vanniyasingam, Thuva; Ye, Chenglin; Yranon, Elgene; Zhang, Shiyuan; Thabane, Lehana

2018-02-01

The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor). Two hundred abstracts (50 from each year) were randomly selected for data extraction. Agreement in reporting of 11 key study conduct items (e.g., sample size) and study characteristics (e.g., funding, number of sites) were extracted by two independent reviewers. Descriptive analyses were conducted to determine the proportion of studies on which there was agreement in reporting of key study conduct items. Generalized estimating equations were used to explore factors associated with agreement in reporting of the primary outcome. Of the 200 included studies, 87% had agreement in reporting of the primary outcome. After adjusting for other covariates, having greater than 50 sites was associated with an increased likelihood of agreement in reporting of the primary outcome (odds ratio=7.1, 95% confidence interval=1.39, 36.27, p=0.018). We identified substantive disagreement in reporting between publications and current clinical trial registry, which were associated with several study characteristics. Further measures are needed to improve reporting given the potential threats to the quality and integrity of scientific research. Copyright © 2017 Elsevier Inc. All rights reserved.

Combined cognitive-strategy and task-specific training improves transfer to untrained activities in sub-acute stroke: An exploratory randomized controlled trial

PubMed Central

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2014-01-01

Purpose The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared to usual outpatient rehabilitation on activity and participation in people less than 3 months post stroke. Methods An exploratory, single blind, randomized controlled trial with a usual care control arm was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either Usual Care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self Efficacy Gauge. Results Thirty-five (35) eligible participants were randomized; 26 completed the intervention. Post-intervention, PQRS change scores demonstrated CO-OP had a medium effect over Usual Care on trained self-selected activities (d=0.5) and a large effect on untrained (d=1.2). At a 3 month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d=1.6) and untrained activities (d=1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and the Self-Efficacy Gauge. Conclusion CO-OP was associated with a large treatment effect on follow up performances of self-selected activities, and demonstrated transfer to untrained activities. A larger trial is warranted. PMID:25416738

Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial.

PubMed

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2015-07-01

The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared with usual outpatient rehabilitation on activity and participation in people <3 months poststroke. An exploratory, single-blind, randomized controlled trial, with a usual-care control arm, was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either usual care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self-Efficacy Gauge. A total of 35 eligible participants were randomized; 26 completed the intervention. Post intervention, PQRS change scores demonstrated that CO-OP had a medium effect over usual care on trained self-selected activities (d = 0.5) and a large effect on untrained activities (d = 1.2). At a 3-month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d = 1.6) and untrained activities (d = 1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and on the Self-Efficacy Gauge. CO-OP was associated with a large treatment effect on follow-up performances of self-selected activities and demonstrated transfer to untrained activities. A larger trial is warranted. © The Author(s) 2014.

Colorectal Adenomas in Participants of the SELECT Randomized Trial of Selenium and Vitamin E for Prostate Cancer Prevention

PubMed Central

Lance, Peter; Alberts, David S.; Thompson, Patricia A.; Fales, Liane; Wang, Fang; Jose, Jerilyn San; Jacobs, Elizabeth T.; Goodman, Phyllis J.; Darke, Amy K.; Yee, Monica; Minasian, Lori; Thompson, Ian M.; Roe, Denise J.

2017-01-01

Selenium and vitamin E micronutrients have been advocated for the prevention of colorectal cancer. Colorectal adenoma occurrence was used as a surrogate for colorectal cancer in an ancillary study to the Selenium and Vitamin E Cancer Prevention Trial (SELECT) for prostate cancer prevention. The primary objective was to measure the effect of selenium (as selenomethionine) on colorectal adenomas occurrence, with the effect of vitamin E (as alpha tocopherol) supplementation on colorectal adenoma occurrence considered as a secondary objective. Participants who underwent lower endoscopy while in SELECT were identified from a subgroup of the 35,533 men randomized in the trial. Adenoma occurrence was ascertained from the endoscopy and pathology reports for these procedures. Relative risk (RR) estimates and 95% confidence intervals (CI) of adenoma occurrence were generated comparing those randomized to selenium versus placebo and to vitamin E versus placebo based on the full factorial design. Evaluable endoscopy information was obtained for 6,546 participants, of whom 2,286 had 1+ adenomas. Apart from 21 flexible sigmoidoscopies, all the procedures yielding adenomas were colonoscopies. Adenomas occurred in 34.2% and 35.7%, respectively, of participants whose intervention included or did not include selenium. Compared with placebo, the RR for adenoma occurrence in participants randomized to selenium was 0.96 (95% CI, 0.90–1.02; P = 0.194). Vitamin E did not affect adenoma occurrence compared to placebo (RR = 1.03, 95% CI, 0.96–1.10; P = 0.38). Neither selenium nor vitamin E supplementation can be recommended for colorectal adenoma prevention. PMID:27777235

Secondary outcome analysis for data from an outcome-dependent sampling design.

PubMed

Pan, Yinghao; Cai, Jianwen; Longnecker, Matthew P; Zhou, Haibo

2018-04-22

Outcome-dependent sampling (ODS) scheme is a cost-effective way to conduct a study. For a study with continuous primary outcome, an ODS scheme can be implemented where the expensive exposure is only measured on a simple random sample and supplemental samples selected from 2 tails of the primary outcome variable. With the tremendous cost invested in collecting the primary exposure information, investigators often would like to use the available data to study the relationship between a secondary outcome and the obtained exposure variable. This is referred as secondary analysis. Secondary analysis in ODS designs can be tricky, as the ODS sample is not a random sample from the general population. In this article, we use the inverse probability weighted and augmented inverse probability weighted estimating equations to analyze the secondary outcome for data obtained from the ODS design. We do not make any parametric assumptions on the primary and secondary outcome and only specify the form of the regression mean models, thus allow an arbitrary error distribution. Our approach is robust to second- and higher-order moment misspecification. It also leads to more precise estimates of the parameters by effectively using all the available participants. Through simulation studies, we show that the proposed estimator is consistent and asymptotically normal. Data from the Collaborative Perinatal Project are analyzed to illustrate our method. Copyright © 2018 John Wiley & Sons, Ltd.

[Impact of an informative intervention on the colorectal cancer screening program in primary care professionals].

PubMed

Benito-Aracil, Llúcia; Binefa-Rodriguez, Gemma; Milà-Diaz, Núria; Lluch-Canut, M Teresa; Puig-Llobet, Montse; Garcia-Martinez, Montse

2015-01-01

To evaluate the impact of an intervention in primary care professionals on their current knowledge about colorectal cancer screening, subsequent surveillance recommendations and referral strategies. Cluster randomized controlled trial. Primary Care Centers in L'Hospitalet de Llobregat (Barcelona). Primary Care Professionals (doctors and nurses). Training session in six of the 12 centers (randomly selected) about the colorrectal cancer screening program, and three emails with key messages. Professionals and centers characteristics and two contextual variables; involvement of professionals in the screening program; information about colorectal cancer knowledge, risk factors, screening procedures, surveillance recommendations and referral strategies. The total score mean on the first questionnaire was 8.07 (1.38) and the second 8.31 (1.39). No statistically significant differences between the intervention and control groups were found, however, in 9 out of 11 questions the percentage of correct responses was increased in the intervention group, mostly related to the surveillance after the diagnostic examination. The intervention improves the percentage of correct answers, especially in those in which worst score obtained in the first questionnaire. This study shows that professionals are familiar with colorectal cancer screening, but there's a need to maintain frequent communication in order to keep up to date the information related to the colorectal cancer screening. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

RECODE: design and baseline results of a cluster randomized trial on cost-effectiveness of integrated COPD management in primary care.

PubMed

Kruis, Annemarije L; Boland, Melinde R S; Schoonvelde, Catharina H; Assendelft, Willem J J; Rutten-van Mölken, Maureen P M H; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Chavannes, Niels H

2013-03-23

Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated disease management (IDM) programs on quality of care and health status of COPD patients in primary care, representing a much larger group of COPD patients. Therefore, the RECODE trial assesses the long-term clinical and cost-effectiveness of IDM in primary care. RECODE is a cluster randomized trial with two years of follow-up, during which 40 clusters of primary care teams (including 1086 COPD patients) are randomized to IDM or usual care. The intervention started with a 2-day multidisciplinary course in which healthcare providers are trained as a team in essential components of effective COPD IDM in primary care. During the course, the team redesigns the care process and defines responsibilities of different caregivers. They are trained in how to use feedback on process and outcome data to guide implement guideline-driven integrated healthcare. Practice-tailored feedback reports are provided at baseline, and at 6 and 12 months. The team learns the details of an ICT program that supports recording of process and outcome measures. Afterwards, the team designs a time-contingent individual practice plan, agreeing on steps to be taken in order to integrate a COPD IDM program into daily practice. After 6 and 12 months, there is a refresher course for all teams simultaneously to enable them to learn from each other's experience. Health status of patients at 12 months is the primary outcome, measured by the Clinical COPD Questionnaire (CCQ). Secondary outcomes include effects on quality of care, disease-specific and generic health-related quality of life, COPD exacerbations, dyspnea, costs of healthcare utilization, and productivity loss. This article presents the protocol and baseline results of the RECODE trial. This study will allow to evaluate whether IDM implemented in primary care can positively influence quality of life and quality of care in mild to moderate COPD patients, thereby making the benefits of multidisciplinary rehabilitation applicable to a substantial part of the COPD population. Netherlands Trial Register (NTR): NTR2268.

The Prevalence and Causes of Primary Infertility in Iran: A Population-Based Study.

PubMed

Kazemijaliseh, Hadigheh; Ramezani Tehrani, Fahimeh; Behboudi-Gandevani, Samira; Hosseinpanah, Farhad; Khalili, Davood; Azizi, Fereidoun

2015-04-19

Primary infertility is a health issue among women over the world. The aim of this study was to investigate the prevalence and causes of primary infertility based on a population-based study in an urban area of Iran. In a cross-sectional study, a total of 1067 married women who participated in the Tehran Lipid and Glucose Study were randomly selected using systematic random sampling. Unmarried women, those with unwilling pregnancy and duration of marriage below one year were excluded from the study. Data was collected by using validated ad-hoc questionnaires. Descriptive and inferential statistics were used for data analysis. The mean (SD) of age and marriage age of the studied women were 40.3 (9.3) and 20.6 (4.49) years, respectively; the overall prevalence of lifetime primary infertility among couples was 17.3% (185/1067). Ovulatory disorder (39.7%) and male factors (29.1%) were the main causes of primary infertility. In addition, 31 (17%) of the women were diagnosed with more than one cause. According to the logistic regression analysis, primary infertility was independently related to the old age of women (OR: 1.37; 95% CI: 1.14-13.63, P.value: 0.001), higher BMI (OR: 1.95; 95% CI: 1.87-4.14, P.value: 0.003), active smoking (OR: 1.47; 95% CI: 1.38-3.53, P.value: 0.012) and higher educational level (OR: 2.23; 95% CI: 1.12-5.53, P.value: 0.03). The prevalence of primary infertility in Iran was higher than the worldwide trends of infertility, indicating that understanding such risks help healthcare providers and policy makers to design and implement interventions to slow down this trend.

Randomizer for High Data Rates

NASA Technical Reports Server (NTRS)

Garon, Howard; Sank, Victor J.

2018-01-01

NASA as well as a number of other space agencies now recognize that the current recommended CCSDS randomizer used for telemetry (TM) is too short. When multiple applications of the PN8 Maximal Length Sequence (MLS) are required in order to fully cover a channel access data unit (CADU), spectral problems in the form of elevated spurious discretes (spurs) appear. Originally the randomizer was called a bit transition generator (BTG) precisely because it was thought that its primary value was to insure sufficient bit transitions to allow the bit/symbol synchronizer to lock and remain locked. We, NASA, have shown that the old BTG concept is a limited view of the real value of the randomizer sequence and that the randomizer also aids in signal acquisition as well as minimizing the potential for false decoder lock. Under the guidelines we considered here there are multiple maximal length sequences under GF(2) which appear attractive in this application. Although there may be mitigating reasons why another MLS sequence could be selected, one sequence in particular possesses a combination of desired properties which offsets it from the others.

Dual dietary intake problems among under-five years old children living in an armed conflict area of southern Thailand.

PubMed

Jeharsae, Rohani; Sangthong, Rassamee; Chongsuvivatwong, Virasakdi

2011-09-01

This survey examined nutritional intake and the effects of armed conflict on energy-protein inadequacy amonng children aged one to less than five years. Fifty health centers were randomly selected. Three children were randomly selected from each 12-month old interval age groups in each health center. Four hundred seventy eight children and their primary caregivers were recruited. Food intake was collected from a single 24-hour food recall and was computed to percentage of the Thai Dietary Reference Intake (DRI). Violent event rates were classified by quartiles. Dietary intake stratified by age groups was examined. Logistic regression was used to examine association between armed conflict and inadequacy of food intake. Average of DRI was above 100% for both energy and protein intake. Snacks contributed to one-fourth of energy intake. Inadequacy of energy and protein intake was 27% and 7%, respectively. There was no association between armed conflict and inadequacy of energy and protein consumption.

Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study.

PubMed

Bergman, R Lindsey; Gonzalez, Araceli; Piacentini, John; Keller, Melody L

2013-10-01

To evaluate the feasibility, acceptability, and preliminary efficacy of a novel behavioral intervention for reducing symptoms of selective mutism and increasing functional speech. A total of 21 children ages 4 to 8 with primary selective mutism were randomized to 24 weeks of Integrated Behavior Therapy for Selective Mutism (IBTSM) or a 12-week Waitlist control. Clinical outcomes were assessed using blind independent evaluators, parent-, and teacher-report, and an objective behavioral measure. Treatment recipients completed a three-month follow-up to assess durability of treatment gains. Data indicated increased functional speaking behavior post-treatment as rated by parents and teachers, with a high rate of treatment responders as rated by blind independent evaluators (75%). Conversely, children in the Waitlist comparison group did not experience significant improvements in speaking behaviors. Children who received IBTSM also demonstrated significant improvements in number of words spoken at school compared to baseline, however, significant group differences did not emerge. Treatment recipients also experienced significant reductions in social anxiety per parent, but not teacher, report. Clinical gains were maintained over 3 month follow-up. IBTSM appears to be a promising new intervention that is efficacious in increasing functional speaking behaviors, feasible, and acceptable to parents and teachers. Copyright © 2013 Elsevier Ltd. All rights reserved.

Study of relation of continuing medical education to quality of family physicians' care.

PubMed

Dunn, E V; Bass, M J; Williams, J I; Borgiel, A E; MacDonald, P; Spasoff, R A

1988-10-01

A random sample of 120 physicians in Ontario was studied to assess quality of care in primary care and test an hypothesis that quality of care was related to continuing medical education (CME) activities. The quality-of-care scores were obtained by an in-office audit of a random selection of charts. The scores were global scores for charting, prevention, the use of 13 classes of drugs, and care of a two-year period for 182 different diagnoses. There were no relationships between global quality-of-care scores based on these randomly chosen charts and either the type or quantity of the physicians' CME activities. These activities were reading journals, attending rounds, attending scientific conferences, having informal consultations, using audio and video cassettes, and engaging in self-assessment. The implications of these findings are significant for future research in CME and for planners of present CME programs.

The effects of epidural analgesia on the course and outcome of labour.

PubMed

Finster, M; Santos, A C

1998-09-01

The potential effects of epidural analgesia on the progress and outcome of labour have been the subject of lasting controversy. Retrospective reviews indicate that epidurals are associated with longer labours and/or an increase in the incidence of instrumental or operative delivery. Similar results were obtained in non-randomized prospective studies. None of them established a causal relationship, because without randomization the selection bias cannot be ruled out. Other factors, such as premature rupture of membranes and maternal socioeconomic status, may affect the outcome of labour. It was also reported that introduction of the on-demand epidural service did not increase the primary caesarean section rate. The few prospective randomized studies are contradictory and not very reliable owing to small patient populations and high cross-over rates. There is, however, unanimity among the authors regarding the superiority of pain relief provided by epidural blocks over systemically administered opioids.

Publication bias in animal research presented at the 2008 Society of Critical Care Medicine Conference.

PubMed

Conradi, Una; Joffe, Ari R

2017-07-07

To determine a direct measure of publication bias by determining subsequent full-paper publication (P) of studies reported in animal research abstracts presented at an international conference (A). We selected 100 random (using a random-number generator) A from the 2008 Society of Critical Care Medicine Conference. Using a data collection form and study manual, we recorded methodology and result variables from A. We searched PubMed and EMBASE to June 2015, and DOAJ and Google Scholar to May 2017 to screen for subsequent P. Methodology and result variables were recorded from P to determine changes in reporting from A. Predictors of P were examined using Fisher's Exact Test. 62% (95% CI 52-71%) of studies described in A were subsequently P after a median 19 [IQR 9-33.3] months from conference presentation. Reporting of studies in A was of low quality: randomized 27% (the method of randomization and allocation concealment not described), blinded 0%, sample-size calculation stated 0%, specifying the primary outcome 26%, numbers given with denominators 6%, and stating number of animals used 47%. Only being an orally presented (vs. poster presented) A (14/16 vs. 48/84, p = 0.025) predicted P. Reporting of studies in P was of poor quality: randomized 39% (the method of randomization and allocation concealment not described), likely blinded 6%, primary outcome specified 5%, sample size calculation stated 0%, numbers given with denominators 34%, and number of animals used stated 56%. Changes in reporting from A to P occurred: from non-randomized to randomized 19%, from non-blinded to blinded 6%, from negative to positive outcomes 8%, from having to not having a stated primary outcome 16%, and from non-statistically to statistically significant findings 37%. Post-hoc, using publication data, P was predicted by having positive outcomes (published 62/62, unpublished 33/38; p = 0.003), or statistically significant results (published 58/62, unpublished 20/38; p < 0.001). Only 62% (95% CI 52-71%) of animal research A are subsequently P; this was predicted by oral presentation of the A, finally having positive outcomes, and finally having statistically significant results. Publication bias is prevalent in critical care animal research.

Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.

PubMed

Camenzind, Edoardo; Wijns, William; Mauri, Laura; Boersma, Eric; Parikh, Keyur; Kurowski, Volkhard; Gao, Runlin; Bode, Christoph; Greenwood, John P; Gershlick, Anthony; O'Neill, William; Serruys, Patrick W; Jorissen, Brenda; Steg, P Gabriel

2009-12-01

Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial.

PubMed

Glina, Sidney; Damiao, Ronaldo; Afif-Abdo, Joao; Santa Maria, Carlos Francisco; Novoa, Raúl; Cairoli, Carlos Eurico Dornelles; Wajsbrot, Dalia; Araya, Gaston

2011-01-01

Although non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.

Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

PubMed

Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

2017-03-01

To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

Naproxen, paracetamol and pamabrom versus paracetamol, pyrilamine and pamabrom in primary dysmenorrhea: a randomized, double-blind clinical trial.

PubMed

Ortiz, Mario I; Murguía-Cánovas, Gabriela; Vargas-López, Laura C; Silva, Rodolfo; González-de la Parra, Mario

2016-10-24

Dysmenorrhea is caused by the discharge of prostaglandins into the uterine tissue; therefore, non-steroidal anti-inflammatory drugs (NSAIDs) are the established initial therapy for dysmenorrhea. Dysmenorrhea therapy may include the administration of drug monotherapy or combination therapy. However, clinical scientific evidence on the efficacy of medications with two or three drugs combined is scarce or nonexistent. To evaluate and compare the efficacy and safety of two oral fixed-dose combinations for the relief of the symptoms of primary dysmenorrhea among Mexican women. One of the combinations is widely used in Mexico (paracetamol, pyrilamine and pamabrom) and the selected comparison was a medication with naproxen sodium, paracetamol and pamabrom based on the pathophysiology of primary dysmenorrhea. This was a single-centre, double blind, experimental, parallel group, randomized trial. Female patients with primary dysmenorrhea, older than 17 years and with pain intensity greater than 45 mm on a visual analogue scale, were included. The patients were then randomized to receive tablets with naproxen sodium, paracetamol and pamabrom or tablets with paracetamol, pyrilamine and pamabrom for one menstrual cycle. Patient evaluations of symptomatology and pain intensity were recorded throughout one menstrual period. Descriptive and inferential statistical analyses were utilized. An intention-to-treat population of 91 women, with a mean age of 21.3 ± 3.2 years, received paracetamol, pyrilamine and pamabrom tablets, and 98 participants, with a mean age of 21.0 ± 3.2 years, received naproxen sodium, paracetamol and pamabrom tablets. The participants’ assessments of pain on the Visual Analogue Scale during the menstrual cycle demonstrated a significant reduction in both treatment groups (p<0.05). There is no significant difference in efficacy between both groups (p>0.05). The results showed that both drug combinations were not different in reducing dysmenorrheic pain. Likewise, both treatments were well tolerated. Therefore, both treatments may be used for the treatment of primary dysmenorrhea.

Mesalazine for the Treatment of Symptomatic Uncomplicated Diverticular Disease of the Colon and for Primary Prevention of Diverticulitis: A Systematic Review of Randomized Clinical Trials.

PubMed

Picchio, Marcello; Elisei, Walter; Brandimarte, Giovanni; Di Mario, Francesco; Malfertheiner, Peter; Scarpignato, Carmelo; Tursi, Antonio

2016-10-01

Symptomatic uncomplicated diverticular disease (SUDD) is a common gastrointestinal disease, because it affects about one fourth of the patient harboring colonic diverticula. To assess the effectiveness of mesalazine in improving symptoms (namely abdominal pain) and in preventing diverticulitis occurrence in patients with SUDD. Only randomized clinical trials (irrespective of language, blinding, or publication status) that compared mesalazine with placebo or any other therapy in SUDD were evaluated. The selected endpoints were symptom relief and diverticulitis occurrence at maximal follow-up. Absolute risk reduction (ARR, with 95% confidence interval) and the number needed to treat were used as measures of the therapeutic effect. Six randomized clinical trials enrolled 1021 patients: 526 patients were treated with mesalazine and 495 with placebo or other therapies. Symptom relief with mesalazine was always larger than that with placebo and other therapies. However, absolute risk reduction was significant only when mesalazine was compared with placebo, a high-fiber diet, and low-dose rifaximin. The incidence of diverticulitis with mesalazine was lower than that observed with placebo and other treatments, being significant only when compared with placebo. Mesalazine is effective in achieving symptom relief and primary prevention of diverticulitis in patients with SUDD.

Waveform analysis-guided treatment versus a standard shock-first protocol for the treatment of out-of-hospital cardiac arrest presenting in ventricular fibrillation: results of an international randomized, controlled trial.

PubMed

Freese, John P; Jorgenson, Dawn B; Liu, Ping-Yu; Innes, Jennifer; Matallana, Luis; Nammi, Krishnakant; Donohoe, Rachael T; Whitbread, Mark; Silverman, Robert A; Prezant, David J

2013-08-27

Ventricular fibrillation (VF) waveform properties have been shown to predict defibrillation success and outcomes among patients treated with immediate defibrillation. We postulated that a waveform analysis algorithm could be used to identify VF unlikely to respond to immediate defibrillation, allowing selective initial treatment with cardiopulmonary resuscitation in an effort to improve overall survival. In a multicenter, double-blind, randomized study, out-of-hospital cardiac arrest patients in 2 urban emergency medical services systems were treated with automated external defibrillators using either a VF waveform analysis algorithm or the standard shock-first protocol. The VF waveform analysis used a predefined threshold value below which return of spontaneous circulation (ROSC) was unlikely with immediate defibrillation, allowing selective treatment with a 2-minute interval of cardiopulmonary resuscitation before initial defibrillation. The primary end point was survival to hospital discharge. Secondary end points included ROSC, sustained ROSC, and survival to hospital admission. Of 6738 patients enrolled, 987 patients with VF of primary cardiac origin were included in the primary analysis. No immediate or long-term survival benefit was noted for either treatment algorithm (ROSC, 42.5% versus 41.2%, P=0.70; sustained ROSC, 32.4% versus 33.4%, P=0.79; survival to admission, 34.1% versus 36.4%, P=0.46; survival to hospital discharge, 15.6% versus 17.2%, P=0.55, respectively). Use of a waveform analysis algorithm to guide the initial treatment of out-of-hospital cardiac arrest patients presenting in VF did not improve overall survival compared with a standard shock-first protocol. Further study is recommended to examine the role of waveform analysis for the guided management of VF.

Machine Learning Algorithms for prediction of regions of high Reynolds Averaged Navier Stokes Uncertainty

NASA Astrophysics Data System (ADS)

Mishra, Aashwin; Iaccarino, Gianluca

2017-11-01

In spite of their deficiencies, RANS models represent the workhorse for industrial investigations into turbulent flows. In this context, it is essential to provide diagnostic measures to assess the quality of RANS predictions. To this end, the primary step is to identify feature importances amongst massive sets of potentially descriptive and discriminative flow features. This aids the physical interpretability of the resultant discrepancy model and its extensibility to similar problems. Recent investigations have utilized approaches such as Random Forests, Support Vector Machines and the Least Absolute Shrinkage and Selection Operator for feature selection. With examples, we exhibit how such methods may not be suitable for turbulent flow datasets. The underlying rationale, such as the correlation bias and the required conditions for the success of penalized algorithms, are discussed with illustrative examples. Finally, we provide alternate approaches using convex combinations of regularized regression approaches and randomized sub-sampling in combination with feature selection algorithms, to infer model structure from data. This research was supported by the Defense Advanced Research Projects Agency under the Enabling Quantification of Uncertainty in Physical Systems (EQUiPS) project (technical monitor: Dr Fariba Fahroo).

Risk factors for goiter in primary school girls in Qom city of Iran.

PubMed

Mousavi, S M; Tavakoli, N; Mardan, F

2006-03-01

Goiter is endemic in Iran. The iodine deficiency disorders program was begun a few years ago in Iran, and the coverage of iodized salt is sufficient now. But, in a periodic yearly medical examination of primary school girls in Qom, the prevalence of goiter was above 30% in 2002. This survey was designed to study the risk factors of goiter in those students. The study was a randomized (multistage, proportional simple random sampling) case-control study. We selected and performed thyroid examinations in 1050 girl students in primary schools in Qom city of Iran in 2002. We found 284 cases: girls in primary schools had goiter in accordance with the clinical exam of World Health Organization classification. Among students who did not present with goiter in the clinical exam, we randomly selected 288 students as the control group. We used a questionnaire to evaluate them for the risk factors of goiter. The mean+/-s.d. ages of cases and controls were 8.7+/-1.3 and 8.9+/-1.3 years, respectively. There is no significant difference between the two groups regarding history of soya, kale, turnip, fish, daily iodized salt usage, education and job of mothers, monthly family income, nationality, immigration and residential situation. By using multinomial logistic regression, we found that storage of iodized salt in open containers, odds ratio (OR): 2.201 (1.412-3.428); P-value <0.0001, medium socioeconomic situation (SES) of family, OR: 2.099 (1.029-4.282), P-value=0.041, district 2 of Qom city, OR: 2.880 (1.376-6.027), P-value=0.005, and district 3 of Qom city, OR: 2.051(1.032-4.078), P-value=0.041, were the major risk factors for goiter in this population. In this study, the main risk factors for goiter were storage of iodized salt in open containers, medium SES and also living in specific districts of Qom city. As the coverage of iodinized salt is over 95% in Iran, we advise the education of the family about storage of iodized salt in closed containers. We also recommend the study of the other risk factors of goiter in the different geographical areas of Iran, because of differences in the SES and nutritional habits. This study was supported by issuing permission letters for our activities: (not funding support) Qom Health Network and Medical Services, Qom Medical University, Qom Primary School Education Office, Fathemieh Medical University.

Identification of polypeptides with selective affinity to intact mouse cerebellar granule neurons from a random peptide-presenting phage library.

PubMed

Hou, Sheng T; Dove, Mike; Anderson, Erica; Zhang, Jiangbing; MacKenzie, C Roger

2004-09-30

Targeting of postmitotic neurons selectively for gene delivery poses a challenge. One way to achieve such a selective targeting is to link the gene delivery vector with small ligand-binding polypeptides which have selective affinity to intact neurons. In order to identify such novel neuron selective polypeptides, we screened a phage-display library displaying random 12-mer polypeptides and subtractively bio-panned for clones having selectivity towards cultured mouse cerebellar granule neurons. The selected phage clones were amplified and sequenced. Affinities of these clones to neurons were determined by the visible presence or absence of fluorescence of phage particles as detected by immunocytochemistry using an antibody to M-13 phage. This affinity was further qualified by how much phage was bound, and where in or on the cell it tended to accumulate. The selectivity of binding to neurons was determined by the negative binding of these clones to several cultured non-neuronal cells, including, primary glial cells, NT2 cells, human embryonic kidney 293 cells, neuroblastoma cells, and mouse 3T3 cells. Among the 46 clones that we have sequenced and characterized, four clones appeared to have excellent selectivity in binding to neurons. Homology comparison of these polypeptides revealed that three of them contained a consensus D(E)-W(F)-I(N)-D-W motif. This motif was also present in the Bdm1 gene product which was predominantly expressed in postnatal brains. Further characterizations of these polypeptides are required to reveal the utilities of these peptides to function as an effective linker to facilitate gene transfer selectively to neurons.

Prevalence of Dyslexia among Male Students in Primary Schools and Its Relationship with Obesity and Being Overweight in Ahvaz, Iran

PubMed Central

Hakim, Ashrafalsadat; Ghorbanibirgani, Alireza

2015-01-01

Background The most important process in childhood and adolescence is learning. The purpose of this study was to determine the prevalence of dyslexia among primary male school students and the relationship between dyslexia, obesity and overweight. Methods This is a cross-sectional study conducted on 1000 male students (first to fifth grade) in primary schools (20 schools) by using the multi-stage random sampling (50 students were selected randomly from each school). Data collection instruments were a weighting scale, a meter for evaluation of obesity and overweight and a reading inventory test for dyslexia. The height and weight were measured based on body mass index (BMI). Data were analyzed using SPSS17 by χ² test. Results 17 and 28 percent of the students were obese and overweight in the first to fifth grades, respectively. On average, the percentage of dyslexia among the unhealthy students was 21 per cent; this rate was 3.5 per cent among the healthy students. In addition, χ² test showed that there was a significant difference between dyslexic and healthy students (P=0.001). Conclusion The prevalence of dyslexia among students with overweight and obesity in comparison to healthy students is high; then close monitoring will ensure that these problems are minimized. PMID:26005691

Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment.

PubMed

Onslow, Mark; Jones, Mark; O'Brian, Sue; Packman, Ann; Menzies, Ross; Lowe, Robyn; Arnott, Simone; Bridgman, Kate; de Sonneville, Caroline; Franken, Marie-Christine

2018-04-17

This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland-Altman plots, analysis of covariance, and Spearman rho correlations. Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial.

PubMed

Henderson, Victor W; Ala, Tom; Sainani, Kristin L; Bernstein, Allan L; Stephenson, B Sue; Rosen, Allyson C; Farlow, Martin R

2015-12-01

To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect. This pilot study was conducted as a randomized, double-blind, placebo-controlled trial, with a planned treatment of 12 months. Women with late-onset AD of mild to moderate severity were randomly allocated to high-dose (120 mg) oral raloxifene or identical placebo provided once daily. The primary outcome compared between treatment groups at 12 months was change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog). Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68-84), and 39 women contributed 12-month outcomes. ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval -0.39 to 0.44, 2-tailed p = 0.89). Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score. Caregiver burden and caregiver distress were similar in both groups. Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group. This study provides Class I evidence that for women with AD, raloxifene does not have a significant cognitive effect. The study lacked the precision to exclude a small effect. © 2015 American Academy of Neurology.

Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial.

PubMed

Jemmott, John B; Jemmott, Loretta S; Ngwane, Zolani; Zhang, Jingwen; Heeren, G Anita; Icard, Larry D; O'Leary, Ann; Mtose, Xoliswa; Teitelman, Anne; Carty, Craig

2014-07-01

To determine whether a health-promotion intervention increases South African men's adherence to physical-activity guidelines. We utilized a cluster-randomized controlled trial design. Eligible clusters, residential neighborhoods near East London, South Africa, were matched in pairs. Within randomly selected pairs, neighborhoods were randomized to theory-based, culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention. Men residing in the neighborhoods and reporting coitus in the previous 3 months were eligible. Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments. Data were collected in 2007-2010. Data collectors, but not facilitators or participants, were blind to group assignment. Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention. Model-estimated probability of meeting physical-activity guidelines was 51.0% in the health-promotion intervention and 44.7% in attention-matched control (OR=1.34; 95% CI, 1.09-1.63), adjusting for baseline prevalence and clustering from 44 neighborhoods. A theory-based culturally congruent intervention increased South African men's self-reported physical activity, a key contributor to deaths from non-communicable diseases in South Africa. ClinicalTrials.gov Identifier: NCT01490359. Copyright © 2014 Elsevier Inc. All rights reserved.

47 CFR 1.1602 - Designation for random selection.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

47 CFR 1.1602 - Designation for random selection.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

Effectiveness of Student Learning during Experimental Work in Primary School.

PubMed

Logar, Ana; Peklaj, Cirila; Ferk Savec, Vesna

2017-09-01

The aim of the research was to optimize the effectiveness of student learning based on experimental work in chemistry classes in Slovenian primary schools. To obtain evidence about how experimental work is implemented during regular chemistry classes, experimental work was videotaped during 19 units of chemistry lessons at 12 Slovenian primary schools from the pool of randomly selected schools. Altogether 332 eight-grade students were involved in the investigation, with an average age of 14.2 years. Students were videotaped during chemistry lessons, and their worksheets were collected afterward. The 12 chemistry teachers, who conducted lessons in these schools, were interviewed before the lessons; their teaching plans were also collected. The collected data was analyzed using qualitative methods. The results indicate that many teachers in Slovenian primary schools are not fully aware of the potential of experimental work integrated into chemistry lessons for the development of students' experimental competence. Further research of the value of different kinds of training to support teachers for the use of experimental work in chemistry teaching is needed.

Effectiveness of Psychological and Educational Interventions to Prevent Depression in Primary Care: A Systematic Review and Meta-Analysis.

PubMed

Conejo-Cerón, Sonia; Moreno-Peral, Patricia; Rodríguez-Morejón, Alberto; Motrico, Emma; Navas-Campaña, Desirée; Rigabert, Alina; Martín-Pérez, Carlos; Rodríguez-Bayón, Antonina; Ballesta-Rodríguez, María Isabel; Luna, Juan de Dios; García-Campayo, Javier; Roca, Miquel; Bellón, Juan Ángel

2017-05-01

Although evidence exists for the efficacy of psychosocial interventions to prevent the onset of depression, little is known about its prevention in primary care. We aimed to evaluate the effectiveness of psychological and educational interventions to prevent depression in primary care. We conducted a systematic review and meta-analysis of relevant randomized controlled trials (RCTs) examining the effect of psychological and educational interventions to prevent depression in nondepressed primary care attendees. We searched MEDLINE, PsycINFO, Web of Science, OpenGrey Repository, Cochrane Central Register of Controlled Trials, and other sources up to May 2016. At least 2 reviewers independently evaluated the eligibility criteria, extracted data, and assessed the risk of bias. We calculated standardized mean differences (SMD) using random-effects models. We selected 14 studies (7,365 patients) that met the inclusion criteria, 13 of which were valid to perform a meta-analysis. Most of the interventions had a cognitive-behavioral orientation, and in only 4 RCTs were the intervention clinicians primary care staff. The pooled SMD was -0.163 (95%CI, -0.256 to -0.070; P = .001). The risk of bias and the heterogeneity (I 2 = 20.6%) were low, and there was no evidence of publication bias. Meta-regression detected no association between SMD and follow-up times or SMD and risk of bias. Subgroup analysis suggested greater effectiveness when the RCTs used care as usual as the comparator compared with those using placebo. Psychological and educational interventions to prevent depression had a modest though statistically significant preventive effect in primary care. Further RCTs using placebo or active comparators are needed. © 2017 Annals of Family Medicine, Inc.

Effectiveness of Psychological and Educational Interventions to Prevent Depression in Primary Care: A Systematic Review and Meta-Analysis

PubMed Central

Conejo-Cerón, Sonia; Moreno-Peral, Patricia; Rodríguez-Morejón, Alberto; Motrico, Emma; Navas-Campaña, Desirée; Rigabert, Alina; Martín-Pérez, Carlos; Rodríguez-Bayón, Antonina; Ballesta-Rodríguez, María Isabel; Luna, Juan de Dios; García-Campayo, Javier; Roca, Miquel; Bellón, Juan Ángel

2017-01-01

PURPOSE Although evidence exists for the efficacy of psychosocial interventions to prevent the onset of depression, little is known about its prevention in primary care. We aimed to evaluate the effectiveness of psychological and educational interventions to prevent depression in primary care. METHODS We conducted a systematic review and meta-analysis of relevant randomized controlled trials (RCTs) examining the effect of psychological and educational interventions to prevent depression in nondepressed primary care attendees. We searched MEDLINE, PsycINFO, Web of Science, OpenGrey Repository, Cochrane Central Register of Controlled Trials, and other sources up to May 2016. At least 2 reviewers independently evaluated the eligibility criteria, extracted data, and assessed the risk of bias. We calculated standardized mean differences (SMD) using random-effects models. RESULTS We selected 14 studies (7,365 patients) that met the inclusion criteria, 13 of which were valid to perform a meta-analysis. Most of the interventions had a cognitive-behavioral orientation, and in only 4 RCTs were the intervention clinicians primary care staff. The pooled SMD was −0.163 (95%CI, −0.256 to −0.070; P = .001). The risk of bias and the heterogeneity (I2 = 20.6%) were low, and there was no evidence of publication bias. Meta-regression detected no association between SMD and follow-up times or SMD and risk of bias. Subgroup analysis suggested greater effectiveness when the RCTs used care as usual as the comparator compared with those using placebo. CONCLUSIONS Psychological and educational interventions to prevent depression had a modest though statistically significant preventive effect in primary care. Further RCTs using placebo or active comparators are needed. PMID:28483893

Impact of gastroesophageal reflux disease on work absenteeism, presenteeism and productivity in daily life: a European observational study

PubMed Central

Gisbert, Javier P; Cooper, Alun; Karagiannis, Dimitrios; Hatlebakk, Jan; Agréus, Lars; Jablonowski, Helmut; Nuevo, Javier

2009-01-01

Background The RANGE (Retrospective ANalysis of GastroEsophageal reflux disease [GERD]) study assessed differences among patients consulting a primary care physician due to GERD-related reasons in terms of: symptoms, diagnosis and management, response to treatment, and effects on productivity, costs and health-related quality of life. This subanalysis of RANGE determined the impact of GERD on productivity in work and daily life. Methods RANGE was conducted at 134 primary care sites across six European countries (Germany, Greece, Norway, Spain, Sweden and the UK). All subjects (aged ≥18 years) who consulted with their primary care physician over a 4-month identification period were screened retrospectively, and those consulting at least once for GERD-related reasons were identified (index visit). From this population, a random sample was selected to enter the study and attended a follow-up appointment, during which the impact of GERD on productivity while working (absenteeism and presenteeism) and in daily life was evaluated using the self-reported Work Productivity and Activity Impairment Questionnaire for patients with GERD (WPAI-GERD). Results Overall, 373,610 subjects consulted with their primary care physician over the 4-month identification period, 12,815 for GERD-related reasons (3.4%); 2678 randomly selected patients attended the follow-up appointment. Average absenteeism due to GERD was highest in Germany (3.2 hours/week) and lowest in the UK (0.4 hours/week), with an average of up to 6.7 additional hours/week lost due to presenteeism in Norway. The average monetary impact of GERD-related work absenteeism and presenteeism were substantial in all countries (from €55/week per employed patient in the UK to €273/patient in Sweden). Reductions in productivity in daily life of up to 26% were observed across the European countries. Conclusion GERD places a significant burden on primary care patients, in terms of work absenteeism and presenteeism and in daily life. The resulting costs to the local economy may be substantial. Improved management of GERD could be expected to lessen the impact of GERD on productivity and reduce costs. PMID:19835583

Impact of gastroesophageal reflux disease on work absenteeism, presenteeism and productivity in daily life: a European observational study.

PubMed

Gisbert, Javier P; Cooper, Alun; Karagiannis, Dimitrios; Hatlebakk, Jan; Agréus, Lars; Jablonowski, Helmut; Nuevo, Javier

2009-10-16

The RANGE (Retrospective ANalysis of GastroEsophageal reflux disease [GERD]) study assessed differences among patients consulting a primary care physician due to GERD-related reasons in terms of: symptoms, diagnosis and management, response to treatment, and effects on productivity, costs and health-related quality of life. This subanalysis of RANGE determined the impact of GERD on productivity in work and daily life. RANGE was conducted at 134 primary care sites across six European countries (Germany, Greece, Norway, Spain, Sweden and the UK). All subjects (aged >or=18 years) who consulted with their primary care physician over a 4-month identification period were screened retrospectively, and those consulting at least once for GERD-related reasons were identified (index visit). From this population, a random sample was selected to enter the study and attended a follow-up appointment, during which the impact of GERD on productivity while working (absenteeism and presenteeism) and in daily life was evaluated using the self-reported Work Productivity and Activity Impairment Questionnaire for patients with GERD (WPAI-GERD). Overall, 373,610 subjects consulted with their primary care physician over the 4-month identification period, 12,815 for GERD-related reasons (3.4%); 2678 randomly selected patients attended the follow-up appointment. Average absenteeism due to GERD was highest in Germany (3.2 hours/week) and lowest in the UK (0.4 hours/week), with an average of up to 6.7 additional hours/week lost due to presenteeism in Norway. The average monetary impact of GERD-related work absenteeism and presenteeism were substantial in all countries (from euro55/week per employed patient in the UK to euro273/patient in Sweden). Reductions in productivity in daily life of up to 26% were observed across the European countries. GERD places a significant burden on primary care patients, in terms of work absenteeism and presenteeism and in daily life. The resulting costs to the local economy may be substantial. Improved management of GERD could be expected to lessen the impact of GERD on productivity and reduce costs.

Nonprescription Antimicrobial Use in a Primary Care Population in the United States

PubMed Central

Zoorob, Roger; Nash, Susan; Trautner, Barbara W.

2016-01-01

Community antimicrobial resistance rates are high in communities with frequent use of nonprescription antibiotics. Studies addressing nonprescription antibiotic use in the United States have been restricted to Latin American immigrants. We estimated the prevalence of nonprescription antibiotic use in the previous 12 months as well as intended use (intention to use antibiotics without a prescription) and storage of antibiotics and examined patient characteristics associated with nonprescription use in a random sample of adults. We selected private and public primary care clinics that serve ethnically and socioeconomically diverse patients. Within the clinics, we used race/ethnicity-stratified systematic random sampling to choose a random sample of primary care patients. We used a self-administered standardized questionnaire on antibiotic use. Multivariate regression analysis was used to identify independent predictors of nonprescription use. The response rate was 94%. Of 400 respondents, 20 (5%) reported nonprescription use of systemic antibiotics in the last 12 months, 102 (25.4%) reported intended use, and 57 (14.2%) stored antibiotics at home. These rates were similar across race/ethnicity groups. Sources of antibiotics used without prescriptions or stored for future use were stores or pharmacies in the United States, “leftover” antibiotics from previous prescriptions, antibiotics obtained abroad, or antibiotics obtained from a relative or friend. Respiratory symptoms were common reasons for the use of nonprescription antibiotics. In multivariate analyses, public clinic patients, those with less education, and younger patients were more likely to endorse intended use. The problem of nonprescription use is not confined to Latino communities. Community antimicrobial stewardship must include a focus on nonprescription antibiotics. PMID:27401572

Selective Cannabinoids for Chronic Neuropathic Pain: A Systematic Review and Meta-analysis.

PubMed

Meng, Howard; Johnston, Bradley; Englesakis, Marina; Moulin, Dwight E; Bhatia, Anuj

2017-11-01

There is a lack of consensus on the role of selective cannabinoids for the treatment of neuropathic pain (NP). Guidelines from national and international pain societies have provided contradictory recommendations. The primary objective of this systematic review and meta-analysis (SR-MA) was to determine the analgesic efficacy and safety of selective cannabinoids compared to conventional management or placebo for chronic NP. We reviewed randomized controlled trials that compared selective cannabinoids (dronabinol, nabilone, nabiximols) with conventional treatments (eg, pharmacotherapy, physical therapy, or a combination of these) or placebo in patients with chronic NP because patients with NP may be on any of these therapies or none if all standard treatments have failed to provide analgesia and or if these treatments have been associated with adverse effects. MEDLINE, EMBASE, and other major databases up to March 11, 2016, were searched. Data on scores of numerical rating scale for NP and its subtypes, central and peripheral, were meta-analyzed. The certainty of evidence was classified using the Grade of Recommendations Assessment, Development, and Evaluation approach. Eleven randomized controlled trials including 1219 patients (614 in selective cannabinoid and 605 in comparator groups) were included in this SR-MA. There was variability in the studies in quality of reporting, etiology of NP, type and dose of selective cannabinoids. Patients who received selective cannabinoids reported a significant, but clinically small, reduction in mean numerical rating scale pain scores (0-10 scale) compared with comparator groups (-0.65 points; 95% confidence interval, -1.06 to -0.23 points; P = .002, I = 60%; Grade of Recommendations Assessment, Development, and Evaluation: weak recommendation and moderate-quality evidence). Use of selective cannabinoids was also associated with improvements in quality of life and sleep with no major adverse effects. Selective cannabinoids provide a small analgesic benefit in patients with chronic NP. There was a high degree of heterogeneity among publications included in this SR-MA. Well-designed, large, randomized studies are required to better evaluate specific dosage, duration of intervention, and the effect of this intervention on physical and psychologic function.

Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics.

PubMed

Kroenke, Kurt; Krebs, Erin; Wu, Jingwei; Bair, Matthew J; Damush, Teresa; Chumbler, Neale; York, Tish; Weitlauf, Sharon; McCalley, Stephanie; Evans, Erica; Barnd, Jeffrey; Yu, Zhangsheng

2013-03-01

Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Although collaborative care interventions are well-established for conditions such as depression, fewer systems-based interventions have been tested for chronic pain. This paper describes the study design and baseline characteristics of the enrolled sample for the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial conducted in five primary care clinics. SCOPE has enrolled 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomized them to either the stepped care intervention or usual care control group. Using a telemedicine collaborative care approach, the intervention couples automated symptom monitoring with a telephone-based, nurse care manager/physician pain specialist team to treat pain. The goal is to optimize analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects undergo comprehensive outcome assessments at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. The primary outcome is pain severity/disability, and secondary outcomes include pain beliefs and behaviors, psychological functioning, health-related quality of life and treatment satisfaction. Innovations of SCOPE include optimized analgesic management (including a stepped care approach, opioid risk stratification, and criteria-based medication adjustment), automated monitoring, and centralized care management that can cover multiple primary care practices. Published by Elsevier Inc.

Colorectal Adenomas in Participants of the SELECT Randomized Trial of Selenium and Vitamin E for Prostate Cancer Prevention.

PubMed

Lance, Peter; Alberts, David S; Thompson, Patricia A; Fales, Liane; Wang, Fang; San Jose, Jerilyn; Jacobs, Elizabeth T; Goodman, Phyllis J; Darke, Amy K; Yee, Monica; Minasian, Lori; Thompson, Ian M; Roe, Denise J

2017-01-01

Selenium and vitamin E micronutrients have been advocated for the prevention of colorectal cancer. Colorectal adenoma occurrence was used as a surrogate for colorectal cancer in an ancillary study to the Selenium and Vitamin E Cancer Prevention Trial (SELECT) for prostate cancer prevention. The primary objective was to measure the effect of selenium (as selenomethionine) on colorectal adenomas occurrence, with the effect of vitamin E (as α-tocopherol) supplementation on colorectal adenoma occurrence considered as a secondary objective. Participants who underwent lower endoscopy while in SELECT were identified from a subgroup of the 35,533 men randomized in the trial. Adenoma occurrence was ascertained from the endoscopy and pathology reports for these procedures. Relative Risk (RR) estimates and 95% confidence intervals (CI) of adenoma occurrence were generated comparing those randomized to selenium versus placebo and to vitamin E versus placebo based on the full factorial design. Evaluable endoscopy information was obtained for 6,546 participants, of whom 2,286 had 1+ adenomas. Apart from 21 flexible sigmoidoscopies, all the procedures yielding adenomas were colonoscopies. Adenomas occurred in 34.2% and 35.7%, respectively, of participants whose intervention included or did not include selenium. Compared with placebo, the RR for adenoma occurrence in participants randomized to selenium was 0.96 (95% CI, 0.90-1.02; P = 0.194). Vitamin E did not affect adenoma occurrence compared with placebo (RR = 1.03; 95% CI, 0.96-1.10; P = 0.38). Neither selenium nor vitamin E supplementation can be recommended for colorectal adenoma prevention. Cancer Prev Res; 10(1); 45-54. ©2016 AACR. ©2016 American Association for Cancer Research.

Record of hospitalizations for ambulatory care sensitive conditions: validation of the hospital information system.

PubMed

Rehem, Tania Cristina Morais Santa Barbara; de Oliveira, Maria Regina Fernandes; Ciosak, Suely Itsuko; Egry, Emiko Yoshikawa

2013-01-01

To estimate the sensitivity, specificity and positive and negative predictive values of the Unified Health System's Hospital Information System for the appropriate recording of hospitalizations for ambulatory care-sensitive conditions. The hospital information system records for conditions which are sensitive to ambulatory care, and for those which are not, were considered for analysis, taking the medical records as the gold standard. Through simple random sampling, a sample of 816 medical records was defined and selected by means of a list of random numbers using the Statistical Package for Social Sciences. The sensitivity was 81.89%, specificity was 95.19%, the positive predictive value was 77.61% and the negative predictive value was 96.27%. In the study setting, the Hospital Information System (SIH) was more specific than sensitive, with nearly 20% of care sensitive conditions not detected. There are no validation studies in Brazil of the Hospital Information System records for the hospitalizations which are sensitive to primary health care. These results are relevant when one considers that this system is one of the bases for assessment of the effectiveness of primary health care.

47 CFR 1.1603 - Conduct of random selection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Conduct of random selection. 1.1603 Section 1.1603 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1603 Conduct of random selection. The...

47 CFR 1.1603 - Conduct of random selection.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Conduct of random selection. 1.1603 Section 1.1603 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1603 Conduct of random selection. The...

[Diagnosis of primary hyperlipoproteinemia in umbilical cord blood (author's transl)].

PubMed

Parwaresch, M R; Radzun, H J; Mäder, C

1977-10-01

The aim of the present investigation was to assay the frequency of primary dyslipoproteinemia in a random sample of one hundred newborns and to describe the minimal methodical requirements for sound diagnosis. After comparison of different methods total lipids were determined by gravimetry, cholesterol and triglycerides by enzymatic methods, nonesterified fatty acids by direct colorimetry; phospholipids were estimated indirectly. All measurements were applied to umbilical cord sera and to lipoprotein fractions separated by selective precipitation. The diagnosis of hyperlipoproteinemia type IV, which is the most frequent one in adults, is highly afflicted with pitfalls in the postnatal period. A primary hyper-alpha-liproteinemia occured in one case and type II-hyperlipoproteinemia in two cases, one of the parents being involved in each case. For mass screening triglycerides should be assayed in serum and cholesterol in precipitated and resolubilized LDL-fraction, for which the minimal requirements are described.

Primary versus secondary closure of cutaneous abscesses in the emergency department: a randomized controlled trial.

PubMed

Singer, Adam J; Taira, Breena R; Chale, Stuart; Bhat, Rahul; Kennedy, David; Schmitz, Gillian

2013-01-01

Cutaneous abscesses have traditionally been treated with incision and drainage (I&D) and left to heal by secondary closure. The objective was to compare the healing rates of cutaneous abscesses following I&D after primary or secondary closure. This was a randomized, controlled, trial, balanced by center, with blocked randomization created by a random-number generator. One urban and one suburban academic emergency department (ED) participated. Subjects were randomized to primary or secondary wound closure following I&D of the abscess. Main outcome measures were the percentage of healed wounds (wound was completely closed by visual inspection; a 40% difference in wound healing was sought) and overall failure rate (need for additional intervention including suture removal, additional drainage, antibiotics, or admission within 7 days after drainage). Fifty-six adult patients with simple localized cutaneous abscesses were included; 29 were randomized to primary closure, and 27 were randomized to secondary closure. Healing rates at 7 days were similar between the primary and secondary closure groups (69.6%, 95% confidence interval [CI] = 49.1% to 84.4% vs. 59.3%, 95% CI = 40.7% to 75.5%; difference 10.3%, 95% CI = -15.8% to 34.1%). Overall failure rates at 7 days were also similar between the primary and secondary closure groups (30.4%, 95% CI = 15.6% to 50.9% vs. 28.6%, 95% CI = 15.2% to 47.1%; difference 1.8%, 95% CI = -24.2% to 28.8%). The rates of wound healing and treatment failure following I&D of simple abscesses in the ED are similar after primary or secondary closure. The authors did not detect a difference of at least 40% in healing rates between primary and secondary closure. © 2013 by the Society for Academic Emergency Medicine.

Rationale and protocol of the Study Of diabetic Nephropathy with AtRasentan (SONAR) trial: A clinical trial design novel to diabetic nephropathy.

PubMed

Heerspink, Hiddo J L; Andress, Dennis L; Bakris, George; Brennan, John J; Correa-Rotter, Ricardo; Dey, Jyotirmoy; Hou, Fan Fan; Kitzman, Dalane W; Kohan, Donald; Makino, Hirofumi; McMurray, John; Perkovic, Vlado; Tobe, Sheldon; Wigderson, Melissa; Parving, Hans-Henrik; de Zeeuw, Dick

2018-06-01

Individuals with diabetes and chronic kidney disease (CKD) are at high risk for renal events. Recent trials of novel treatments have been negative, possibly because of variability in response to treatment of the target risk factor. Atrasentan is a selective endothelin A receptor antagonist that reduces urinary albumin-to-creatinine ratio (UACR), with a large variability between patients. We are assessing its effect on renal outcomes in the Study Of diabetic Nephropathy with AtRasentan (SONAR; NCT01858532) with an enrichment design (>30% lowering of albuminuria) to select patients most likely to benefit. SONAR is a randomized, double-blind, placebo-controlled trial with approximately 3500 participants who have stage 2-4 CKD and macroalbuminuria and are receiving a maximum tolerated dose of a renin-angiotensin system inhibitor. After 6 weeks of exposure to atrasentan 0.75 mg once daily (enrichment period), participants with ≥30% UACR decrease and no tolerability issues (responders) were randomly assigned to placebo or atrasentan 0.75 mg/day. The responder group will be used for primary efficacy and safety analyses. Approximately 1000 participants with <30% UACR reduction (non-responders) were also randomized to placebo or atrasentan. The primary endpoint is a composite of a sustained doubling of serum creatinine or end-stage renal disease. The original power calculation indicated that a total of 425 primary renal events in the responder group provides 90% power to detect a 27% reduction in relative risk (alpha level of .05). SONAR aims to determine whether atrasentan added to guideline-recommended therapies safely reduces the risk of CKD progression and delays the onset of end-stage renal disease in patients with type 2 diabetes and nephropathy. SONAR also aims to establish whether the enrichment of patients based on their initial "surrogate" response to atrasentan will deliver a trial design in accord with personalized treatment of diabetic kidney disease. © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Involving patients in setting priorities for healthcare improvement: a cluster randomized trial.

PubMed

Boivin, Antoine; Lehoux, Pascale; Lacombe, Réal; Burgers, Jako; Grol, Richard

2014-02-20

Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Professionals established priorities among themselves, without patient involvement. A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. The primary outcome was the level of agreement between patients' and professionals' priorities. Secondary outcomes included professionals' intention to use the selected quality indicators, and the costs of patient involvement. Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p < 0.01). Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p < 0.01). Professionals' intention to use the selected quality indicators was similar in intervention and control sites. Patient involvement increased the costs of the prioritization process by 17%, and required 10% more time to reach consensus on common priorities. Patient involvement can change priorities driving healthcare improvement at the population level. Future research should test the generalizability of these findings to other contexts, and assess its impact on patient care. The Netherlands National Trial Register #NTR2496.

Involving patients in setting priorities for healthcare improvement: a cluster randomized trial

PubMed Central

2014-01-01

Background Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Methods Design: Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Setting: Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Intervention: Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Control: Professionals established priorities among themselves, without patient involvement. Participants: A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. Outcomes: The primary outcome was the level of agreement between patients’ and professionals’ priorities. Secondary outcomes included professionals’ intention to use the selected quality indicators, and the costs of patient involvement. Results Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p < 0.01). Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p < 0.01). Professionals’ intention to use the selected quality indicators was similar in intervention and control sites. Patient involvement increased the costs of the prioritization process by 17%, and required 10% more time to reach consensus on common priorities. Conclusions Patient involvement can change priorities driving healthcare improvement at the population level. Future research should test the generalizability of these findings to other contexts, and assess its impact on patient care. Trial registration The Netherlands National Trial Register #NTR2496. PMID:24555508

Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials.

PubMed

Sun, Xin; Briel, Matthias; Busse, Jason W; Akl, Elie A; You, John J; Mejza, Filip; Bala, Malgorzata; Diaz-Granados, Natalia; Bassler, Dirk; Mertz, Dominik; Srinathan, Sadeesh K; Vandvik, Per Olav; Malaga, German; Alshurafa, Mohamed; Dahm, Philipp; Alonso-Coello, Pablo; Heels-Ansdell, Diane M; Bhatnagar, Neera; Johnston, Bradley C; Wang, Li; Walter, Stephen D; Altman, Douglas G; Guyatt, Gordon H

2009-11-09

Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered. The objectives of this study are: 1) to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2) to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3) to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes. A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize the conduct and reporting of subgroup analyses, and claim and interpretation of subgroup effects in randomized trials.

Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials

PubMed Central

Sun, Xin; Briel, Matthias; Busse, Jason W; Akl, Elie A; You, John J; Mejza, Filip; Bala, Malgorzata; Diaz-Granados, Natalia; Bassler, Dirk; Mertz, Dominik; Srinathan, Sadeesh K; Vandvik, Per Olav; Malaga, German; Alshurafa, Mohamed; Dahm, Philipp; Alonso-Coello, Pablo; Heels-Ansdell, Diane M; Bhatnagar, Neera; Johnston, Bradley C; Wang, Li; Walter, Stephen D; Altman, Douglas G; Guyatt, Gordon H

2009-01-01

Background Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered. The objectives of this study are: 1) to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2) to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3) to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. Methods We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes. Discussion A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize the conduct and reporting of subgroup analyses, and claim and interpretation of subgroup effects in randomized trials. PMID:19900273

Bridging the Gaps Between Patients and Primary Care in China: A Nationwide Representative Survey

PubMed Central

Wong, William C. W.; Jiang, Sunfang; Ong, Jason J.; Peng, Minghui; Wan, Eric; Zhu, Shanzhu; Lam, Cindy L. K.; Kidd, Michael R.; Roland, Martin

2017-01-01

PURPOSE China introduced a national policy of developing primary care in 2009, establishing 8,669 community health centers (CHCs) by 2014 that employed more than 300,000 staff. These facilities have been underused, however, because of public mistrust of physicians and overreliance on specialist care. METHODS We selected a stratified random sample of CHCs throughout China based on geographic distribution and urban-suburban ratios between September and December 2015. Two questionnaires, 1 for lead clinicians and 1 for primary care practitioners (PCPs), asked about the demographics of the clinic and its clinical and educational activities. Responses were obtained from 158 lead clinicians in CHCs and 3,580 PCPs (response rates of 84% and 86%, respectively). RESULTS CHCs employed a median of 8 physicians and 13 nurses, but only one-half of physicians were registered as PCPs, and few nurses had training specifically for primary care. Although virtually all clinics were equipped with stethoscopes (98%) and sphygmomanometers (97%), only 43% had ophthalmoscopes and 64% had facilities for gynecologic examination. Clinical care was selectively skewed toward certain chronic diseases. Physicians saw a median of 12.5 patients per day. Multivariate analysis showed that more patients were seen daily by physicians in CHCs organized by private hospitals and those having pharmacists and nurses. CONCLUSIONS Our survey confirms China’s success in establishing a large, mostly young primary care workforce and providing ongoing professional training. Facilities are basic, however, with few clinics providing the comprehensive primary care required for a wide range of common physical and mental conditions. Use of CHCs by patients remains low. PMID:28483889

Rates of Cerebral Protein Synthesis in Primary Visual Cortex during Sleep-Dependent Memory Consolidation, a Study in Human Subjects.

PubMed

Picchioni, Dante; Schmidt, Kathleen C; McWhirter, Kelly K; Loutaev, Inna; Pavletic, Adriana J; Speer, Andrew M; Zametkin, Alan J; Miao, Ning; Bishu, Shrinivas; Turetsky, Kate M; Morrow, Anne S; Nadel, Jeffrey L; Evans, Brittney C; Vesselinovitch, Diana M; Sheeler, Carrie A; Balkin, Thomas J; Smith, Carolyn B

2018-05-15

If protein synthesis during sleep is required for sleep-dependent memory consolidation, we might expect rates of cerebral protein synthesis (rCPS) to increase during sleep in the local brain circuits that support performance on a particular task following training on that task. To measure circuit-specific brain protein synthesis during a daytime nap opportunity, we used the L-[1-(11)C]leucine positron emission tomography (PET) method with simultaneous polysomnography. We trained subjects on the visual texture discrimination task (TDT). This was followed by a nap opportunity during the PET scan, and we retested them later in the day after the scan. The TDT is considered retinotopically specific, so we hypothesized that higher rCPS in primary visual cortex would be observed in the trained hemisphere compared to the untrained hemisphere in subjects who were randomized to a sleep condition. Our results indicate that the changes in rCPS in primary visual cortex depended on whether subjects were in the wakefulness or sleep condition but were independent of the side of the visual field trained. That is, only in the subjects randomized to sleep, rCPS in the right primary visual cortex was higher than the left regardless of side trained. Other brain regions examined were not so affected. In the subjects who slept, performance on the TDT improved similarly regardless of the side trained. Results indicate a regionally selective and sleep-dependent effect that occurs with improved performance on the TDT.

[Compliance with process indicators in people with type 2 diabetes and linking incentives in Primary Care].

PubMed

Pascual de la Pisa, Beatriz; Márquez Calzada, Cristina; Cuberos Sánchez, Carla; Cruces Jiménez, José Miguel; Fernández Gamaza, Manuel; Martínez Martínez, María Isabel

2015-03-01

Pay-for-performance programs to improve the quality of health care are extending gradually, particularly en Primary Health Care. Our aim was to explore the relationship between the degree of compliance with the process indicators (PrI) of type 2 diabetes (T2DM) in Primary Care and linkage to incentives. Cross-sectional, descriptive, observational study. Six Primary Health Care centers in Seville Aljarafe District randomly selected and stratified by population size. From 3.647 adults included in Integrated Healthcare Process of T2DM during 2008, 366 patients were included according sample size calculation by stratified random sampling. PrI: eye and feet examination, glycated hemoglobin, lipid profile, microalbuminuria and electrocardiogram. Confounding: Age, gender, characteristics town for patients and professional variables. The mean age was 66.36 years (standard deviation [DE]: 11,56); 48.9% were women. PrI with better compliance were feet examination, glycated hemoglobin and lipid profile (59.6%, 44.3% and 44%, respectively). 2.7% of patients had simultaneous compliance of the six PrI and 11.74% of patients three PrI linkage to incentives. Statistical association was observed in the compliance of the PrI incentives linked or not (P=.001). The degree of compliance with the PrI for screening chronic complications of T2DM is mostly low but this was higher on indicators linked to incentives. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

A systematic review of lifestyle counseling for diverse patients in primary care.

PubMed

Melvin, Cathy L; Jefferson, Melanie S; Rice, LaShanta J; Nemeth, Lynne S; Wessell, Andrea M; Nietert, Paul J; Hughes-Halbert, Chanita

2017-07-01

Prior research and systematic reviews have examined strategies related to weight management, less is known about lifestyle and behavioral counseling interventions optimally suited for implementation in primary care practices generally, and among racial and ethnic patient populations. Primary care practitioners may find it difficult to access and use available research findings on effective behavioral and lifestyle counseling strategies and to assess their effects on health behaviors among their patients. This systematic review compiled existing evidence from randomized trials to inform primary care providers about which lifestyle and behavioral change interventions are shown to be effective for changing patients' diet, physical activity and weight outcomes. Searches identified 444 abstracts from all sources (01/01/2004-05/15/2014). Duplicate abstracts were removed, selection criteria applied and dual abstractions conducted for 106 full text articles. As of June 12, 2015, 29 articles were retained for inclusion in the body of evidence. Randomized trials tested heterogeneous multi-component behavioral interventions for an equally wide array of outcomes in three population groups: diverse patient populations (23 studies), African American patients only (4 studies), and Hispanic/Mexican American/Latino patients only (2 studies). Significant and consistent findings among diverse populations showed that weight and physical activity related outcomes were more amenable to change via lifestyle and behavioral counseling interventions than those associated with diet modification. Evidence to support specific interventions for racial and ethnic minorities was promising, but insufficient based on the small number of studies. Copyright © 2017. Published by Elsevier Inc.

Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial.

PubMed

Lee, Janet T; Marquez, Thao T; Clerc, Daniel; Gie, Olivier; Demartines, Nicolas; Madoff, Robert D; Rothenberger, David A; Christoforidis, Dimitrios

2014-11-01

Surgical site infection after stoma reversal is common. The optimal skin closure technique after stoma reversal has been widely debated in the literature. We hypothesized that pursestring near-complete closure of the stoma site would lead to fewer surgical site infections compared with conventional primary closure. This study was a parallel prospective multicenter randomized controlled trial. This study was conducted at 2 university medical centers. Patients (N = 122) presenting for elective colostomy or ileostomy reversal were selected. Pursestring versus conventional primary closure of stoma sites were compared. Stoma site surgical site infection within 30 days of surgery, overall surgical site infection, delayed healing (open wound for >30 days), time to wound epithelialization, and patient satisfaction were the primary outcomes measured. The pursestring group had a significantly lower stoma site infection rate (2% vs 15%, p = 0.01). There was no difference in delayed healing or patient satisfaction between groups. Time to epithelialization was measured in only 51 patients but was significantly longer in the pursestring group (34.6 ± 20 days vs 24.1 ± 17 days, p = 0.02). This study was limited by the variability in procedures and surgeons, the limited follow-up after 30 days, and the inability to perform blinding. Pursestring closure after stoma reversal has a lower risk of stoma site surgical site infection than conventional primary closure, although wounds may take longer to heal with the use of this approach. NCT01713452 (www.clinicaltrials.gov).

Fluoxetine and imipramine: are there differences in cost-utility for depression in primary care?

PubMed

Serrano-Blanco, Antoni; Suárez, David; Pinto-Meza, Alejandra; Peñarrubia, Maria T; Haro, Josep Maria

2009-02-01

Depressive disorders generate severe personal burden and high economic costs. Cost-utility analyses of the different therapeutical options are crucial to policy-makers and clinicians. Previous cost-utility studies, comparing selective serotonin reuptake inhibitors and tricyclic antidepressants, have used modelling techniques or have not included indirect costs in the economic analyses. To determine the cost-utility of fluoxetine compared with imipramine for treating depressive disorders in primary care. A 6-month randomized prospective naturalistic study comparing fluoxetine with imipramine was conducted in three primary care centres in Spain. One hundred and three patients requiring antidepressant treatment for a DSM-IV depressive disorder were included in the study. Patients were randomized either to fluoxetine (53 patients) or to imipramine (50 patients) treatment. Patients were treated with antidepressants according to their general practitioner's usual clinical practice. Outcome measures were the quality of life tariff of the European Quality of Life Questionnaire: EuroQoL-5D (five domains), direct costs, indirect costs and total costs. Subjects were evaluated at the beginning of treatment and after 1, 3 and 6 months. Incremental cost-utility ratios (ICUR) were obtained. To address uncertainty in the ICUR's sampling distribution, non-parametric bootstrapping was carried out. Taking into account adjusted total costs and incremental quality of life gained, imipramine dominated fluoxetine with 81.5% of the bootstrap replications in the dominance quadrant. Imipramine seems to be a better cost-utility antidepressant option for treating depressive disorders in primary care.

The antimicrobial effectiveness of 25% propolis extract in root canal irrigation of primary teeth.

PubMed

Verma, Manjesh Kumar; Pandey, Ramesh Kumar; Khanna, Richa; Agarwal, Jyotsna

2014-01-01

The choice of irrigating solution used in root canals of primary teeth is complicated by their complex morphology and paucity of associated literature. Propolis is a natural product that has gained interest in this context due to its antibacterial effectiveness against several endodontic pathogens. The present study was undertaken to assess the potential of water-soluble 25% propolis extract against microorganisms present in root canals of primary teeth during endodontic procedures. The child patients in the age group of 4-7 years with radiographic evidence of carious pulp exposure were included in the study. Definitive selection was done after gaining access into the pulp chamber and root canals of the selected teeth. The clinical and radiographic evidence of pathosis was ruled out for inclusion in the study. The selected teeth were divided into two groups randomly. In Group A 0.9% isotonic saline and in Group B 25% extract water-soluble propolis were used as irrigating solution, respectively. The bacterial samples were collected both pre- and post-irrigation and were transferred for microbial assay. STAISTISTICAL ANALYSIS: Wilcoxon matched signed rank test was used to compare the pre-and post-irrigation bacterial counts. Mann-Whitney test was used to compare the mean change (pre-post) in bacterial colony counts of groups in the study. Antimicrobial effectiveness of 25% water-soluble extract of propolis in the root canals of primary teeth was confirmed in the present study. The reduction in the mean bacterial colony counts of all the isolated bacteria was noticed higher in Group B than Group A. The results of the present study have confirmed that the antibacterial effectiveness of water-soluble extract of propolis in the root canals of primary teeth in vivo. Considering the low toxicity concerns and antibacterial effectiveness, water-soluble extract of 25% propolis can be advocated as a root canal irrigant in endodontic treatment of primary teeth.

Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of DESTRESS-PC

DTIC Science & Technology

2009-08-01

Bryant, R, Engel, CC (2004). A therapist-assisted internet self-help program for traumatic stress . Professional Psychology: Research and Practice, 35...Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of “DESTRESS-PC” PRINCIPAL INVESTIGATOR: Charles Engel...Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of DESTRESS-PC 5b. GRANT NUMBER

Socio-economic Status, Needs, and Utilization of Dental Services among Rural Adults in a Primary Health Center Area in Southern India

PubMed Central

Bommireddy, Vikram Simha; Pachava, Srinivas; Ravoori, Srinivas; Sanikommu, Suresh; Talluri, Devaki; Vinnakota, Narayana Rao

2014-01-01

Background: The oral disease burden in India is showing a steady increase in the recent years. Utilization of dental care being the major factor affecting the oral health status of the population is used as an important tool in oral health policy decision-making and is measured in terms of the number of dental visits per annum. Materials and Methods: A cross-sectional house to house questionnaire survey was conducted in three rural clusters which were randomly selected from a total of eight clusters served by a primary health center. Simple random sampling was used to select 100 houses from each cluster. Screening was done to examine the existing oral diseases. A total of 385 completed questionnaires were collected from 300 houses. Results: Of 385 study subjects, 183 have experienced previous dental problems. Major dental problem experienced by the study subjects was toothache (68.85%) and the treatment underwent was extraction (50.27%). Most preferred treatment centers by the study subjects were private dental hospital (68.25%) and reason identified was accessibility which constituted (45.24%) of all the reasons given. Negative attitude toward dental care is one of the important barriers; 50.8% of the non-utilizers felt dental treatment is not much important. Conclusion: Person’s attitude, lack of awareness, and affordability remain the barriers for utilization of dental services. Effective methods have to be exercised to breach such barriers. PMID:25628485

Identifying Depressed Older Adults in Primary Care: A Secondary Analysis of a Multisite Randomized Controlled Trial

PubMed Central

Voils, Corrine I.; Olsen, Maren K.; Williams, John W.; for the IMPACT Study Investigators

2008-01-01

Objective: To determine whether a subset of depressive symptoms could be identified to facilitate diagnosis of depression in older adults in primary care. Method: Secondary analysis was conducted on 898 participants aged 60 years or older with major depressive disorder and/or dysthymic disorder (according to DSM-IV criteria) who participated in the Improving Mood–Promoting Access to Collaborative Treatment (IMPACT) study, a multisite, randomized trial of collaborative care for depression (recruitment from July 1999 to August 2001). Linear regression was used to identify a core subset of depressive symptoms associated with decreased social, physical, and mental functioning. The sensitivity and specificity, adjusting for selection bias, were evaluated for these symptoms. The sensitivity and specificity of a second subset of 4 depressive symptoms previously validated in a midlife sample was also evaluated. Results: Psychomotor changes, fatigue, and suicidal ideation were associated with decreased functioning and served as the core set of symptoms. Adjusting for selection bias, the sensitivity of these 3 symptoms was 0.012 and specificity 0.994. The sensitivity of the 4 symptoms previously validated in a midlife sample was 0.019 and specificity was 0.997. Conclusion: We identified 3 depression symptoms that were highly specific for major depressive disorder in older adults. However, these symptoms and a previously identified subset were too insensitive for accurate diagnosis. Therefore, we recommend a full assessment of DSM-IV depression criteria for accurate diagnosis. PMID:18311416

Habitat selection of a declining white-tailed deer herd in the central Black Hills, South Dakota and Wyoming

NASA Astrophysics Data System (ADS)

Deperno, Christopher Shannon

Habitat selection, survival rates, the Black Hills National Forest Habitat Capability Model (HABCAP), and the USDA Forest Service Geographic Information System (GIS) data base were evaluated for a declining white-tailed deer (Odocoileus virginianus dacotensis) herd in the central Black Hills of South Dakota and Wyoming. From July 1993 through July 1996, 73 adult and yearling female and 12 adult and yearling male white-tailed deer were radiocollared and visually monitored. Habitat information was collected at 4,662 white-tailed deer locations and 1,087 random locations. Natural mortality (71%) was the primary cause of female mortality, followed by harvest (22.5%) and accidental causes (6.5%). More females died in spring (53.2%) than in fall (22.6%), winter (14.5%), or summer (9.7%). Male mortality resulted from hunting in fall (66.7%) and natural causes in spring (33.3%). Survival rates for all deer by year were 62.1% in 1993, 51.1% in 1994, 56.4% in 1995, and 53.9% in 1996 and were similar (P = 0.691) across years. During winter, white-tailed deer selected ponderosa pine- (Pinus ponderosa ) deciduous and burned pine cover types. Overstory-understory habitats selected included pine/grass-forb, pine/bearberry (Arctostaphylos uva-ursi), pine/snowberry (Symphoricarpos albus), burned pine/grass-forb, and pine/shrub habitats. Structural stages selected included sapling-pole pine stands with >70% canopy cover, burned pine sapling-pole and saw-timber stands with <40% canopy cover. Bedding locations were represented by saw-timber pine structural stages with >40% canopy cover and all sapling-pole pine structural stages; sapling-pole stands with >70% canopy cover received the greatest use. White-tailed deer primarily fed in pine saw-timber structural stage with less than 40% canopy cover. Overall, selected habitats contained lower amounts of grass/forb, shrubs, and litter than random locations. Male and female deer generally bedded in areas that were characterized by greater horizontal cover than feeding and random sites. When feeding and bedding sites were combined males selected areas that were characterized by greater levels of horizontal cover than females. During summer, white-tailed deer selected pine-deciduous, aspen (Populus tremuloides), aspen-coniferous, spruce (Picea glauca), and spruce-deciduous cover types. Overstory-understory habitats selected included pine/juniper (Juniperus communis), aspen/shrubs, spruce/juniper, and spruce/shrub habitats. Structural stages selected included pine, aspen, and spruce sapling pole stands with all levels (0--40%, 41--70%, 71--100%) of canopy cover. All habitat types (i.e., pine, aspen, and spruce) were used as bedding locations with pine sapling-pole structural stages with >70% canopy cover used most, whereas pine saw-timber structural stage with less than 40% canopy cover was primarily used for feeding. Females bedded in areas that were characterized by greater horizontal cover than feeding and random sites, whereas male feeding sites had greater horizontal cover characteristics than bedding or random locations.

The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial.

PubMed

Zhang, Ying; Sun, Jin; Zhang, Yun-Jiao; Chai, Qian-Yun; Zhang, Kang; Ma, Hong-Li; Wu, Xiao-Ke; Liu, Jian-Ping

2016-10-21

Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting. We specified detailed methods for data management and statistical analyses. Statistics in corresponding tables, listings, and graphs were outlined. The SAP provided more detailed information than trial protocol on data management and statistical analysis methods. Any post hoc analyses could be identified via referring to this SAP, and the possible selection bias and performance bias will be reduced in the trial. This study is registered at ClinicalTrials.gov, NCT01138930 , registered on 7 June 2010.

The Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS) study: rationale and study design.

PubMed

Rossi, G P; Seccia, T M; Miotto, D; Zucchetta, P; Cecchin, D; Calò, L; Puato, M; Motta, R; Caielli, P; Vincenzi, M; Ramondo, G; Taddei, S; Ferri, C; Letizia, C; Borghi, C; Morganti, A; Pessina, A C

2012-08-01

It is unclear whether revascularization of renal artery stenosis (RAS) by means of percutaneous renal angioplasty and stenting (PTRAS) is advantageous over optimal medical therapy. Hence, we designed a randomized clinical trial based on an optimized patient selection strategy and hard experimental endpoints. Primary objective of this study is to determine whether PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate (GFR) in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan. Secondary objectives of this study are to establish whether the two treatments are equivalent in lowering blood pressure, preserving overall renal function and regressing target organ damage, preventing cardiovascular events and improving quality of life. The study is designed as a prospective multicentre randomized, un-blinded two-arm study. Eligible patients will have clinical and angio-CT evidence of RAS. Inclusion criteria is RAS affecting the main renal artery or its major branches either >70% or, if <70, with post-stenotic dilatation. Renal function will be assessed with 99mTc-DTPA renal scintigraphy. Patients will be randomized to either arms considering both resistance index value in the ischemic kidney and the presence of unilateral/bilateral stenosis. Primary experimental endpoint will be the GFR of the ischemic kidney, assessed as quantitative variable by 99TcDTPA, and the loss of ischemic kidney defined as a categorical variable.

Ibuprofen versus acetaminophen as a post-partum analgesic for women with severe pre-eclampsia: randomized clinical study.

PubMed

Vigil-De Gracia, Paulino; Solis, Valentin; Ortega, Nelson

2017-06-01

To compare differences in blood pressure levels between patients with severe post-partum pre-eclampsia using ibuprofen or acetaminophen. A randomized controlled trial was made in women with severe pre-eclampsia or superimposed pre-eclampsia after vaginal birth. The patient was randomly selected to receive either 400 mg of ibuprofen every 8 h or 1 g of acetaminophen every 6 h during the post-partum. The primary variable was systolic hypertension ≥150 mmHg and/or diastolic hypertension ≥100 mmHg after the first 24 h post-partum. Secondary variables were the arterial blood pressure readings at 24, 48, 72, and 96 h post-partum and maternal complications. A total of 113 patients were studied: 56 in the acetaminophen group and 57 in the ibuprofen group. With regard to the primary outcome, more cases were significantly hypertensive in the ibuprofen group (36/57; 63.1%) than in the acetaminophen group (16/56; 28.6%). Severe hypertension (≥160/110 mmHg) was not significantly different between the groups, 14.5% (acetaminophen) and 24.5% (ibuprofen). The levels of arterial blood pressure show a hammock-shaped curve independent of the drug used, however, is more noticeable with ibuprofen. This study shows that ibuprofen significantly elevates blood pressure in women with severe pre-eclampsia during the post-partum period.

Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone-corticotrophine releasing hormone test and other potential endophenotypes in healthy first-degree relatives of persons with depression

PubMed Central

Knorr, Ulla; Vinberg, Maj; Klose, Marianne; Feldt-Rasmussen, Ulla; Hilsted, Linda; Gade, Anders; Haastrup, Eva; Paulson, Olaf; Wetterslev, Jørn; Gluud, Christian; Gether, Ulrik; Kessing, Lars

2009-01-01

Background Endophenotypes are heritable markers, which are more prevalent in patients and their healthy relatives than in the general population. Recent studies point at disturbed regulation of the hypothalamic-pituitary-adrenocortical axis as a possible endophenotype for depression. We hypothesize that potential endophenotypes for depression may be affected by selective serotonin re-uptake inhibitor antidepressants in healthy first-degree relatives of depressed patients. The primary outcome measure is the change in plasma cortisol in the dexamethasone-corticotrophin releasing hormone test from baseline to the end of intervention. Methods The AGENDA trial is designed as a participant, investigator, observer, and data-analyst-blinded randomized trial. Participants are 80 healthy first-degree relatives of patients with depression. Participants are randomized to escitalopram 10 mg per day versus placebo for four weeks. Randomization is stratified by gender and age. The primary outcome measure is the change in plasma cortisol in the dexamethasone-corticotrophin releasing hormone test at entry before intervention to after four weeks of intervention. With the inclusion of 80 participants, a 60% power is obtained to detect a clinically relevant difference in the primary outcome between the intervention and the placebo group. Secondary outcome measures are changes from baseline to four weeks in scores of: 1) cognition and 2) neuroticism. Tertiary outcomes measures are changes from baseline to four weeks in scores of: 1) depression and anxiety symptoms; 2) subjective evaluations of depressive symptoms, perceived stress, quality of life, aggression, sleep, and pain; and 3) salivary cortisol at eight different timepoints during an ordinary day. Assessments are undertaken by assessors blinded to the randomization group. Trial registration Local Ethics Committee: H-KF 307413 Danish Medicines Agency: 2612-3162. EudraCT: 2006-001750-28. Danish Data Agency: 2006-41-6737. ClinicalTrials.gov: NCT 00386841 PMID:19671139

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

Exceptionally low prevalence of refractive error and visual impairment in schoolchildren from Lao People's Democratic Republic.

PubMed

Casson, Robert J; Kahawita, Shyalle; Kong, Aimee; Muecke, James; Sisaleumsak, Siphetthavong; Visonnavong, Vithoune

2012-10-01

Vientiane Province is an urbanizing region in Southeast Asia. We aimed to determine the prevalence of refractive error and visual impairment in primary school-aged children in this region. Prospective, cross-sectional survey. A total of 2899 schoolchildren from Vientiane Province, Lao People's Democratic Republic (Lao PDR). Ten districts from Vientiane were randomly selected and 2 primary schools were randomly selected from each district. All children aged 6 to 11 years at selected schools were eligible to participate. The examination included visual acuity (VA) testing, cycloplegic retinoscopy with subjective refinement if indicated, ocular motility testing, and anterior segment and fundus examinations in visually impaired children. Cycloplegic refraction and VA. There was an estimated total of 3330 children who were eligible to participate, and data were recorded from 2899 (87%) of these children. Complete refractive data were available on 2842 children (85% of eligible population). The mean spherical equivalent (SE) in the right eyes was +0.60 diopter (D) (95% confidence interval [CI], 0.49-0.72), and the mean SE in the left eyes was +0.59 (95% CI, 0.50-0.68). The prevalence of hyperopia was 2.8% (95% CI, 1.9-3.7; 88 subjects), and the prevalence of myopia was 0.8% (95% CI, 0.3-1.4; 24 subjects). The majority of children (98%; 95% CI, 97.0-99.0) had normal unaided binocular VA (at least 20/32 in their better eye). The overall prevalence of any visual impairment (presenting VA <20/32 in the better eye) was 1.9% (95% CI, 1.0-2.9; 55 subjects). In multivariate logistic regression analysis, age (P = 0.001) was a significant predictor, and female gender (P = 0.08) and Yao ethnicity (P = 0.09) were borderline significant predictors of the presence of any visual impairment. Visual impairment is not a public health concern in this primary school-aged population; however, visually impaired children in the community were not studied. From this baseline, future surveys could determine the effect of increasing urbanization on myopia prevalence in this population. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Immobilization in External Rotation Versus Internal Rotation After Primary Anterior Shoulder Dislocation: A Meta-analysis of Randomized Controlled Trials.

PubMed

Whelan, Daniel B; Kletke, Stephanie N; Schemitsch, Geoffrey; Chahal, Jaskarndip

2016-02-01

The recurrence rate after primary anterior shoulder dislocation is high, especially in young, active individuals. Recent studies have suggested external rotation immobilization as a method to reduce the rate of recurrent shoulder dislocation in comparison to traditional sling immobilization. To assess and summarize evidence from randomized controlled trials on the effect of internal rotation versus external rotation immobilization on the rate of recurrence after primary anterior shoulder dislocation. Meta-analysis. PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and abstracts from recent proceedings were searched for eligible studies. Two reviewers selected studies for inclusion, assessed methodological quality, and extracted data. Six randomized controlled trials (632 patients) were included in this review. Demographic and prognostic variables measured at baseline were similar in the pooled groups. The average age was 30.1 years in the pooled external rotation group and 30.3 years in the pooled internal rotation group. Two studies found that external rotation immobilization reduced the rate of recurrence after initial anterior shoulder dislocation compared with conventional internal rotation immobilization, whereas 4 studies failed to find a significant difference between the 2 groups. This meta-analysis suggested no overall significant difference in the rate of recurrence among patients treated with internal rotation versus external rotation immobilization (risk ratio, 0.69; 95% CI, 0.42-1.14; P = .15). There was no significant difference in the rate of compliance between internal and external rotation immobilization (P = .43). The Western Ontario Shoulder Instability Index scores were pooled across 3 studies, and there was no significant difference between the 2 groups (P = .54). Immobilization in external rotation is not significantly more effective in reducing the recurrence rate after primary anterior shoulder dislocation than immobilization in internal rotation. Additionally, this review suggests that there is minimal difference in patients' perceptions of their health-related quality of life after immobilization in internal versus external rotation. © 2015 The Author(s).

Impact of Nano Hydroxyapatite, Nano Silver Fluoride and Sodium Fluoride Varnish on Primary Teeth Enamel Remineralization: An In Vitro Study

PubMed Central

Nozari, Ali; Ajami, Shabnam; Rafiei, Azade

2017-01-01

Introduction Dental caries is still prevailing worldwide, although different anti caries products have been introduced. Each remineralizing agent has its own shortcomings. Therefore, looking for new agents to have benefits of previous ones with lesser side effects is worthwhile. Aim To determine the remineralization ability of NaF varnish, nano-Hydroxyapatite Serum (n-HAP) and Nano Silver Fluoride (NSF) on enamel of primary anterior teeth. Materials and Methods Incipient caries were induced in primary sound anterior teeth by storing each specimen in demineralization solution for 72 hours. Then they were randomly divided into four groups of 15 samples each: (1) NaF varnish; (2) n-HAP repairing serum; (3) NSF and (4) no treatment (control). Surface Microhardness (SMH) was assessed with Vickers micro hardness tester before and after demineralization and after 10 days of pH-cycling. A total of 12 random specimens from groups 1 to 4 (3 random samples of each group) were examined by Atomic Force Microscopy (AFM). The SMH values were analysed with one-way and repeated measures ANOVA. Level of significance was set at p=0.05. Results Post lesion SMH values significantly decreased in all groups (p<0.001). Post treatment SMH values significantly increased in comparison to post lesion ones (p<0.001) except for control group which was not different statistically (p=0.86). The highest SMH values were observed in NSF group (mean 222.90 ± 28.79). Statistically significant differences were shown between all groups (p<0.05). However, NaF varnish and n-HAP groups were not statistically different (p=0.165). AFM images demonstrated protective layers in all treated groups. Conclusion The results of this in vitro study suggest that NSF could have the greatest remineralization efficacy. NaF varnish and n-HAP serum were similar in remineralizing initial caries. Future clinical studies are recommended for selection of the most appropriate remineralizing agent in primary teeth. PMID:29207844

PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

PubMed

Douglas, Pamela S; Hoffmann, Udo; Lee, Kerry L; Mark, Daniel B; Al-Khalidi, Hussein R; Anstrom, Kevin; Dolor, Rowena J; Kosinski, Andrzej; Krucoff, Mitchell W; Mudrick, Daniel W; Patel, Manesh R; Picard, Michael H; Udelson, James E; Velazquez, Eric J; Cooper, Lawton

2014-06-01

Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Copyright © 2014 Mosby, Inc. All rights reserved.

PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

PubMed Central

Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

2014-01-01

Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

Trade-off study and computer simulation for assessing spacecraft pointing accuracy and stability capabilities

NASA Astrophysics Data System (ADS)

Algrain, Marcelo C.; Powers, Richard M.

1997-05-01

A case study, written in a tutorial manner, is presented where a comprehensive computer simulation is developed to determine the driving factors contributing to spacecraft pointing accuracy and stability. Models for major system components are described. Among them are spacecraft bus, attitude controller, reaction wheel assembly, star-tracker unit, inertial reference unit, and gyro drift estimators (Kalman filter). The predicted spacecraft performance is analyzed for a variety of input commands and system disturbances. The primary deterministic inputs are the desired attitude angles and rate set points. The stochastic inputs include random torque disturbances acting on the spacecraft, random gyro bias noise, gyro random walk, and star-tracker noise. These inputs are varied over a wide range to determine their effects on pointing accuracy and stability. The results are presented in the form of trade- off curves designed to facilitate the proper selection of subsystems so that overall spacecraft pointing accuracy and stability requirements are met.

The Impact of a School-Based Hygiene, Water Quality and Sanitation Intervention on Soil-Transmitted Helminth Reinfection: A Cluster-Randomized Trial

PubMed Central

Freeman, Matthew C.; Clasen, Thomas; Brooker, Simon J.; Akoko, Daniel O.; Rheingans, Richard

2013-01-01

We conducted a cluster-randomized trial to assess the impact of a school-based water treatment, hygiene, and sanitation program on reducing infection with soil-transmitted helminths (STHs) after school-based deworming. We assessed infection with STHs at baseline and then at two follow-up rounds 8 and 10 months after deworming. Forty government primary schools in Nyanza Province, Kenya were randomly selected and assigned to intervention or control arms. The intervention reduced reinfection prevalence (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.31–1.00) and egg count (rate ratio [RR] 0.34, CI 0.15–0.75) of Ascaris lumbricoides. We found no evidence of significant intervention effects on the overall prevalence and intensity of Trichuris trichiura, hookworm, or Schistosoma mansoni reinfection. Provision of school-based sanitation, water quality, and hygiene improvements may reduce reinfection of STHs after school-based deworming, but the magnitude of the effects may be sex- and helminth species-specific. PMID:24019429

Primary ICD-therapy in patients with advanced heart failure: selection strategies and future trials.

PubMed

Frankenstein, Lutz; Zugck, Christian; Nelles, Manfred; Schellberg, Dieter; Remppis, Andrew; Katus, Hugo

2008-09-01

For allocation of primary ICD-therapy, a possible lower limit of inclusion criteria--defining overly advanced heart failure--is less well investigated. Also, a multi-variable approach to stratification beyond ejection fraction (LVEF) appears warranted. We examined whether adding a selection limit of peak VO(2)

About the necessity to manage events coded with MedDRA prior to statistical analysis: proposal of a strategy with application to a randomized clinical trial, ANRS 099 ALIZE.

PubMed

Journot, Valérie; Tabuteau, Sophie; Collin, Fidéline; Molina, Jean-Michel; Chene, Geneviève; Rancinan, Corinne

2008-03-01

Since 2003, the Medical Dictionary for Regulatory Activities (MedDRA) is the regulatory standard for safety report in clinical trials in the European Community. Yet, we found no published example of a practical experience for a scientifically oriented statistical analysis of events coded with MedDRA. We took advantage of a randomized trial in HIV-infected patients with MedDRA-coded events to explain the difficulties encountered during the events analysis and the strategy developed to report events consistently with trial-specific objectives. MedDRA has a rich hierarchical structure, which allows the grouping of coded terms into 5 levels, the highest being "System Organ Class" (SOC). Each coded term may be related to several SOCs, among which one primary SOC is defined. We developed a new general 5-step strategy to select a SOC as trial primary SOC, consistently with trial-specific objectives for this analysis. We applied it to the ANRS 099 ALIZE trial, where all events were coded with MedDRA version 3.0. We compared the MedDRA and the ALIZE primary SOCs. In the ANRS 099 ALIZE trial, 355 patients were recruited, and 3,722 events were reported and documented, among which 35% had multiple SOCs (2 to 4). We applied the proposed 5-step strategy. Altogether, 23% of MedDRA primary SOCs were modified, mainly from MedDRA primary SOCs "Investigations" (69%) and "Ear and labyrinth disorders" (6%), for the ALIZE primary SOCs "Hepatobiliary disorders" (35%), "Musculoskeletal and connective tissue disorders" (21%), and "Gastrointestinal disorders" (15%). MedDRA largely enhanced in size and complexity with versioning and the development of Standardized MedDRA Queries. Yet, statisticians should not systematically rely on primary SOCs proposed by MedDRA to report events. A simple general 5-step strategy to re-classify events consistently with the trial-specific objectives might be useful in HIV trials as well as in other fields.

The effect of synaptic plasticity on orientation selectivity in a balanced model of primary visual cortex

PubMed Central

Gonzalo Cogno, Soledad; Mato, Germán

2015-01-01

Orientation selectivity is ubiquitous in the primary visual cortex (V1) of mammals. In cats and monkeys, V1 displays spatially ordered maps of orientation preference. Instead, in mice, squirrels, and rats, orientation selective neurons in V1 are not spatially organized, giving rise to a seemingly random pattern usually referred to as a salt-and-pepper layout. The fact that such different organizations can sharpen orientation tuning leads to question the structural role of the intracortical connections; specifically the influence of plasticity and the generation of functional connectivity. In this work, we analyze the effect of plasticity processes on orientation selectivity for both scenarios. We study a computational model of layer 2/3 and a reduced one-dimensional model of orientation selective neurons, both in the balanced state. We analyze two plasticity mechanisms. The first one involves spike-timing dependent plasticity (STDP), while the second one considers the reconnection of the interactions according to the preferred orientations of the neurons. We find that under certain conditions STDP can indeed improve selectivity but it works in a somehow unexpected way, that is, effectively decreasing the modulated part of the intracortical connectivity as compared to the non-modulated part of it. For the reconnection mechanism we find that increasing functional connectivity leads, in fact, to a decrease in orientation selectivity if the network is in a stable balanced state. Both counterintuitive results are a consequence of the dynamics of the balanced state. We also find that selectivity can increase due to a reconnection process if the resulting connections give rise to an unstable balanced state. We compare these findings with recent experimental results. PMID:26347615

The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial.

PubMed

Carles, Misericòrdia; Martínez-Alonso, Montserrat; Pons, Anna; Pérez-Lacasta, Maria José; Perestelo-Pérez, Lilisbeth; Sala, Maria; Vidal, Carmen; Garcia, Montse; Toledo-Chávarri, Ana; Codern, Núria; Feijoo-Cid, Maria; Romero, Anabel; Pla, Roger; Soler-González, Jorge; Castells, Xavier; Rué, Montserrat

2017-09-12

The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening. A two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2-3 weeks after the intervention. This is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country. ClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

PubMed Central

Macciò, Antonio; Madeddu, Clelia; Serpe, Roberto; Massa, Elena; Dessì, Mariele; Panzone, Filomena; Contu, Paolo

2010-01-01

Purpose. A phase III, randomized study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia—lean body mass (LBM), resting energy expenditure (REE), and fatigue—and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines. Patients and Methods. Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were randomly assigned to one of five treatment arms: arm 1, medroxyprogesterone (500 mg/day) or megestrol acetate (320 mg/day); arm 2, oral supplementation with eicosapentaenoic acid; arm 3, L-carnitine (4 g/day); arm 4, thalidomide (200 mg/day); and arm 5, a combination of the above. Treatment duration was 4 months. Results. Analysis of variance showed a significant difference between treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms. Conclusion. The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite, IL-6, GPS, and ECOG PS score was the combination regimen that included all selected agents. PMID:20156909

A model study of aggregates composed of spherical soot monomers with an acentric carbon shell

NASA Astrophysics Data System (ADS)

Luo, Jie; Zhang, Yongming; Zhang, Qixing

2018-01-01

Influences of morphology on the optical properties of soot particles have gained increasing attentions. However, studies on the effect of the way primary particles are coated on the optical properties is few. Aimed to understand how the primary particles are coated affect the optical properties of soot particles, the coated soot particle was simulated using the acentric core-shell monomers model (ACM), which was generated by randomly moving the cores of concentric core-shell monomers (CCM) model. Single scattering properties of the CCM model with identical fractal parameters were calculated 50 times at first to evaluate the optical diversities of different realizations of fractal aggregates with identical parameters. The results show that optical diversities of different realizations for fractal aggregates with identical parameters cannot be eliminated by averaging over ten random realizations. To preserve the fractal characteristics, 10 realizations of each model were generated based on the identical 10 parent fractal aggregates, and then the results were averaged over each 10 realizations, respectively. The single scattering properties of all models were calculated using the numerically exact multiple-sphere T-matrix (MSTM) method. It is found that the single scattering properties of randomly coated soot particles calculated using the ACM model are extremely close to those using CCM model and homogeneous aggregate (HA) model using Maxwell-Garnett effective medium theory. Our results are different from previous studies. The reason may be that the differences in previous studies were caused by fractal characteristics but not models. Our findings indicate that how the individual primary particles are coated has little effect on the single scattering properties of soot particles with acentric core-shell monomers. This work provides a suggestion for scattering model simplification and model selection.

Evaluation of the Efficacy, Safety, and Tolerability of BI 409306, a Novel Phosphodiesterase 9 Inhibitor, in Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.

PubMed

Brown, David; Nakagome, Kazuyuki; Cordes, Joachim; Brenner, Ronald; Gründer, Gerhard; Keefe, Richard S E; Riesenberg, Robert; Walling, David P; Daniels, Kristen; Wang, Lara; McGinniss, Jennifer; Sand, Michael

2018-05-01

Patients with cognitive impairment associated with schizophrenia may benefit from treatments targeting dysfunctional glutamatergic neurotransmission. BI 409306, a potent and selective phosphodiesterase 9 inhibitor, was assessed in patients with schizophrenia using a learn-and-confirm adaptive trial design. This double-blind, parallel-group trial randomized patients 2:1:1:1:1 to once-daily placebo or BI 409306 (10, 25, 50, or 100 mg) for 12 weeks. Stage 1 (learn) assessed change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) scores (week 12) to identify ≥1 meaningful endpoints for stage 2 (confirm). If no domains showed efficacy, change from baseline in Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) composite scores (week 12) was the primary endpoint. The key secondary endpoint was change from baseline in Schizophrenia Cognition Rating Scale (SCoRS) total score. Safety was monitored. Five hundred eighteen patients were randomized. In stage 1, CANTAB did not differentiate between BI 409306 and placebo (n = 120), so the primary endpoint of change from baseline in MCCB composite score was analyzed in 450 patients in stage 2. There was no significant difference between BI 409306 (1.2-2.8) and placebo (2.5) in MCCB composite score change. BI 409306 did not significantly improve change from baseline in SCoRS total score (-3.1 to -2.0) vs placebo (-2.5). Adverse events were dose-dependent, increasing from 33.3% (10 mg) to 53.5% (100 mg), vs 36.4% for placebo. The primary endpoint of cognitive function improvement was not met. BI 409306 was well-tolerated, with an acceptable safety profile.

Evolution of Randomized Trials in Advanced/Metastatic Soft Tissue Sarcoma: End Point Selection, Surrogacy, and Quality of Reporting.

PubMed

Zer, Alona; Prince, Rebecca M; Amir, Eitan; Abdul Razak, Albiruni

2016-05-01

Randomized controlled trials (RCTs) in soft tissue sarcoma (STS) have used varying end points. The surrogacy of intermediate end points, such as progression-free survival (PFS), response rate (RR), and 3-month and 6-month PFS (3moPFS and 6moPFS) with overall survival (OS), remains unknown. The quality of efficacy and toxicity reporting in these studies is also uncertain. A systematic review of systemic therapy RCTs in STS was performed. Surrogacy between intermediate end points and OS was explored using weighted linear regression for the hazard ratio for OS with the hazard ratio for PFS or the odds ratio for RR, 3moPFS, and 6moPFS. The quality of reporting for efficacy and toxicity was also evaluated. Fifty-two RCTs published between 1974 and 2014, comprising 9,762 patients, met the inclusion criteria. There were significant correlations between PFS and OS (R = 0.61) and between RR and OS (R = 0.51). Conversely, there were nonsignificant correlations between 3moPFS and 6moPFS with OS. A reduction in the use of RR as the primary end point was observed over time, favoring time-based events (P for trend = .02). In 14% of RCTs, the primary end point was not met, but the study was reported as being positive. Toxicity was comprehensively reported in 47% of RCTs, whereas 14% inadequately reported toxicity. In advanced STS, PFS and RR seem to be appropriate surrogates for OS. There is poor correlation between OS and both 3moPFS and 6moPFS. As such, caution is urged with the use of these as primary end points in randomized STS trials. The quality of toxicity reporting and interpretation of results is suboptimal. © 2016 by American Society of Clinical Oncology.

0.025-inch vs 0.035-inch guide wires for wire-guided cannulation during endoscopic retrograde cholangiopancreatography: A randomized study

PubMed Central

Kitamura, Katsuya; Yamamiya, Akira; Ishii, Yu; Sato, Yoshiki; Iwata, Tomoyuki; Nomoto, Tomohiro; Ikegami, Akitoshi; Yoshida, Hitoshi

2015-01-01

AIM: To compare the clinical outcomes between 0.025-inch and 0.035-inch guide wires (GWs) when used in wire-guided cannulation (WGC). METHODS: A single center, randomized study was conducted between April 2011 and March 2013. This study was approved by the Medical Ethics Committee at our hospital. Informed, written consent was obtained from each patient prior to study enrollment. Three hundred and twenty-two patients with a naïve papilla of Vater who underwent endoscopic retrograde cholangiopancreatography (ERCP) for the purpose of selective bile duct cannulation with WGC were enrolled in this study. Fifty-three patients were excluded based on the exclusion criteria, and 269 patients were randomly allocated to two groups by a computer and analyzed: the 0.025-inch GW group (n = 109) and the 0.035-inch GW group (n = 160). The primary endpoint was the success rate of selective bile duct cannulation with WGC. Secondary endpoints were the success rates of the pancreatic GW technique and precutting, selective bile duct cannulation time, ERCP procedure time, the rate of pancreatic duct stent placement, the final success rate of selective bile duct cannulation, and the incidence of post-ERCP pancreatitis (PEP). RESULTS: The primary success rates of selective bile duct cannulation with WGC were 80.7% (88/109) and 86.3% (138/160) for the 0.025-inch and the 0.035-inch groups, respectively (P = 0.226). There were no statistically significant differences in the success rates of selective bile duct cannulation using the pancreatic duct GW technique (46.7% vs 52.4% for the 0.025-inch and 0.035-inch groups, respectively; P = 0.884) or in the success rates of selective bile duct cannulation using precutting (66.7% vs 63.6% for the 0.025-inch and 0.035-inch groups, respectively; P = 0.893). The final success rates for selective bile duct cannulation using these procedures were 92.7% (101/109) and 97.5% (156/160) for the 0.025-inch and 0.035-inch groups, respectively (P = 0.113). There were no significant differences in selective bile duct cannulation time (median ± interquartile range: 3.7 ± 13.9 min vs 4.0 ± 11.2 min for the 0.025-inch and 0.035-inch groups, respectively; P = 0.851), ERCP procedure time (median ± interquartile range: 32 ± 29 min vs 30 ± 25 min for the 0.025-inch and 0.035-inch groups, respectively; P = 0.184) or in the rate of pancreatic duct stent placement (14.7% vs 15.6% for the 0.025-inch and 0.035-inch groups, respectively; P = 0.832). The incidence of PEP was 2.8% (3/109) and 2.5% (4/160) for the 0.025-inch and 0.035-inch groups, respectively (P = 0.793). CONCLUSION: The thickness of the GW for WGC does not appear to affect either the success rate of selective bile duct cannulation or the incidence of PEP. PMID:26290646

Application of a multipurpose unequal probability stream survey in the Mid-Atlantic Coastal Plain

USGS Publications Warehouse

Ator, S.W.; Olsen, A.R.; Pitchford, A.M.; Denver, J.M.

2003-01-01

A stratified, spatially balanced sample with unequal probability selection was used to design a multipurpose survey of headwater streams in the Mid-Atlantic Coastal Plain. Objectives for the survey include unbiased estimates of regional stream conditions, and adequate coverage of unusual but significant environmental settings to support empirical modeling of the factors affecting those conditions. The design and field application of the survey are discussed in light of these multiple objectives. A probability (random) sample of 175 first-order nontidal streams was selected for synoptic sampling of water chemistry and benthic and riparian ecology during late winter and spring 2000. Twenty-five streams were selected within each of seven hydrogeologic subregions (strata) that were delineated on the basis of physiography and surficial geology. In each subregion, unequal inclusion probabilities were used to provide an approximately even distribution of streams along a gradient of forested to developed (agricultural or urban) land in the contributing watershed. Alternate streams were also selected. Alternates were included in groups of five in each subregion when field reconnaissance demonstrated that primary streams were inaccessible or otherwise unusable. Despite the rejection and replacement of a considerable number of primary streams during reconnaissance (up to 40 percent in one subregion), the desired land use distribution was maintained within each hydrogeologic subregion without sacrificing the probabilistic design.

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

PubMed

Miller, David; Topping, Keith; Thurston, Allen

2010-09-01

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

Cluster randomized trial of a mHealth intervention "ImTeCHO" to improve delivery of proven maternal, neonatal, and child care interventions through community-based Accredited Social Health Activists (ASHAs) by enhancing their motivation and strengthening supervision in tribal areas of Gujarat, India: study protocol for a randomized controlled trial.

PubMed

Modi, Dhiren; Desai, Shrey; Dave, Kapilkumar; Shah, Shobha; Desai, Gayatri; Dholakia, Nishith; Gopalan, Ravi; Shah, Pankaj

2017-06-09

To facilitate the delivery of proven maternal, neonatal, and child health (MNCH) services, a new cadre of village-based frontline workers, called the Accredited Social Health Activists (ASHAs), was created in 2005 under the aegis of the National Rural Health Mission in India. Evaluations have noted that coverage of selected MNCH services to be delivered by the ASHAs is low. Reasons for low coverage are inadequate supervision and support to ASHAs apart from insufficient skills, poor quality of training, and complexity of tasks to be performed. The proposed study aims to implement and evaluate an innovative intervention based on mobile phone technology (mHealth) to improve the performance of ASHAs through better supervision and support in predominantly tribal and rural communities of Gujarat, India. This is a two-arm, stratified, cluster randomized trial of 36 months in which the units of randomization will be Primary Health Centers (PHCs). There are 11 PHCs in each arm. The intervention is a newly built mobile phone application used in the public health system and evaluated in three ways: (1) mobile phone as a job aid to ASHAs to increase coverage of MNCH services; (2) mobile phone as a job aid to ASHAs and Auxiliary Nurse Midwives (ANMs) to increase coverage of care among complicated cases by facilitating referrals, if indicated and home-based care; (3) web interface as a job aid for medical officers and PHC staff to improve supervision and support to the ASHA program. Participants of the study are pregnant women, mothers, infants, ASHAs, and PHC staff. Primary outcome measures are a composite index made of critical, proven MNCH services and the proportion of neonates who were visited by ASHAs at home within the first week of birth. Secondary outcomes include coverage of selected MNCH services and care sought by complicated cases. Outcomes will be measured by conducting household surveys at baseline and post-intervention which will be compared with usual practice in the control area, where the current level of services provided by the government will continue. The primary analysis will be intention to treat. This study will help answer some critical questions about the effectiveness and feasibility of implementing an mHealth solution in an area of MNCH services. Clinical Trial Registry of India, CTRI/2015/06/005847 . Registered on 3 June 2015.

Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.

PubMed

Mark, Daniel B; Anstrom, Kevin J; Clapp-Channing, Nancy E; Knight, J David; Boineau, Robin; Goertz, Christine; Rozema, Theodore C; Liu, Diane M; Nahin, Richard L; Rosenberg, Yves; Drisko, Jeanne; Lee, Kerry L; Lamas, Gervasio A

2014-07-01

The National Institutes of Health.funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stablecoronary disease patients aged .50 years who were .6 months post.myocardial infarction (2003.2010) to 40 infusions ofa multicomponent EDTA chelation solution or placebo. Chelation reduced the primary composite end point of mortality,recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio, 0.82; 95%confidence interval, 0.69.0.99; P=0.035). In a randomly selected subset of 911 patients, we prospectively collected a battery of quality-of-life(QOL) instruments at baseline and at 6, 12, and 24 months after randomization. The prespecified primary QOL measures were the Duke Activity Status Index (Table I in the Data Supplement) and the Medical Outcomes Study Short-Form 36 Mental Health Inventory-5. All comparisons were by intention to treat. Baseline clinical and QOL variables were well balanced in the 451 patients randomized to chelation and in the 460 patients randomized to placebo. The Duke Activity Status Index improved in both groups during the first 6 months of therapy, but we found no evidence for a treatment-related difference (mean difference [chelation.placebo] during follow-up, 0.9 [95% confidence interval, .0.7 to 2.6; P=0.27]).There was no statistically significant evidence of a treatment-related difference in the Mental Health Inventory-5 during follow-up (mean difference, 1.0; 95% confidence interval, .0.1 to 2.0; P=0.08). None of the secondary QOL measures showed a consistent treatment-related difference. In stable, predominantly asymptomatic coronary disease patients with a history of myocardial infarction,EDTA chelation therapy did not have a detectable effect on QOL during 2 years of follow-up. URL: http://clinicaltrials.gov. Unique identifier: NCT00044213.

A randomized controlled trial of a pharmacist consultation program for family physicians and their elderly patients

PubMed Central

Sellors, John; Kaczorowski, Janusz; Sellors, Connie; Dolovich, Lisa; Woodward, Christel; Willan, Andrew; Goeree, Ron; Cosby, Roxanne; Trim, Kristina; Sebaldt, Rolf; Howard, Michelle; Hardcastle, Linda; Poston, Jeff

2003-01-01

Background Pharmacists can improve patient outcomes in institutional and pharmacy settings, but little is known about their effectiveness as consultants to primary care physicians. We examined whether an intervention by a specially trained pharmacist could reduce the number of daily medication units taken by elderly patients, as well as costs and health care use. Methods We conducted a randomized controlled trial in family practices in 24 sites in Ontario. We randomly allocated 48 randomly selected family physicians (69.6% participation rate) to the intervention or the control arm, along with 889 (69.5% participation rate) of their randomly selected community-dwelling, elderly patients who were taking 5 or more medications daily. In the intervention group, pharmacists conducted face-to-face medication reviews with the patients and then gave written recommendations to the physicians to resolve any drug-related problems. Process outcomes included the number of drug-related problems identified among the senior citizens in the intervention arm and the proportion of recommendations implemented by the physicians. Results After 5 months, seniors in the intervention and control groups were taking a mean of 12.4 and 12.2 medication units per day respectively (p = 0.50). There were no statistically significant differences in health care use or costs between groups. A mean of 2.5 drug-related problems per senior was identified in the intervention arm. Physicians implemented or attempted to implement 72.3% (790/1093) of the recommendations. Interpretation The intervention did not have a significant effect on patient outcomes. However, physicians were receptive to the recommendations to resolve drug-related problems, suggesting that collaboration between physicians and pharmacists is feasible. PMID:12847034

A case study of outsourced primary healthcare services in Sindh, Pakistan: is this a real reform?

PubMed

Tanzil, Sana; Zahidie, Aysha; Ahsan, Adeel; Kazi, Ambreen; Shaikh, Babar Tasneem

2014-06-25

Since a decade, low and middle income countries have a rising trend of contracting their primary healthcare services to NGOs. In Pakistan, public sector often lacks capacity to effectively & equitably manage the healthcare services. It led the government to outsource the administration of primary health care services to a semi-autonomous government entity i.e. Peoples' Primary Healthcare Initiative (PPHI). This small scale study has assessed the quality of healthcare services at the contracted Basic Health Units (BHUs) with the PPHI and compared it with those managed by the local district government in the province of Sindh. A cross-sectional mix methods survey was conducted in November 2011. Two BHUs of each type were selected from the districts Karachi and Thatta in Sindh province. BHUs were selected randomly and a purposive sampling technique was used to recruit the study participants at the two study sites. Focus group discussions were conducted with patients visiting the facility while in-depth interviews were conducted with service providers. An observation based resource availability checklist was also administered. There was a significant difference between the PPHI and the district government administered BHUs with regard to infrastructure, availability of essential medicines, basic medical appliances, mini-lab facilities and vehicles for referrals. These BHUs were found to have sufficient number of trained clinical staff and no punctuality and retention issues whatsoever. The district government administered BHUs presented a dismal picture in all the aspects. Out-sourcing of primary healthcare facilities has resulted in significantly improved certain aspects quality and responsiveness of primary healthcare services. This strategy is likely to achieve an efficient and perhaps an equitable healthcare delivery in low and middle income countries where governments have limited capacity to manage healthcare services.

A case study of outsourced primary healthcare services in Sindh, Pakistan: is this a real reform?

PubMed Central

2014-01-01

Background Since a decade, low and middle income countries have a rising trend of contracting their primary healthcare services to NGOs. In Pakistan, public sector often lacks capacity to effectively & equitably manage the healthcare services. It led the government to outsource the administration of primary health care services to a semi-autonomous government entity i.e. Peoples’ Primary Healthcare Initiative (PPHI). This small scale study has assessed the quality of healthcare services at the contracted Basic Health Units (BHUs) with the PPHI and compared it with those managed by the local district government in the province of Sindh. Methods A cross-sectional mix methods survey was conducted in November 2011. Two BHUs of each type were selected from the districts Karachi and Thatta in Sindh province. BHUs were selected randomly and a purposive sampling technique was used to recruit the study participants at the two study sites. Focus group discussions were conducted with patients visiting the facility while in-depth interviews were conducted with service providers. An observation based resource availability checklist was also administered. Results There was a significant difference between the PPHI and the district government administered BHUs with regard to infrastructure, availability of essential medicines, basic medical appliances, mini-lab facilities and vehicles for referrals. These BHUs were found to have sufficient number of trained clinical staff and no punctuality and retention issues whatsoever. The district government administered BHUs presented a dismal picture in all the aspects. Conclusion Out-sourcing of primary healthcare facilities has resulted in significantly improved certain aspects quality and responsiveness of primary healthcare services. This strategy is likely to achieve an efficient and perhaps an equitable healthcare delivery in low and middle income countries where governments have limited capacity to manage healthcare services. PMID:24965769

Prevalence of health promotion programs in primary health care units in Brazil

PubMed Central

Ramos, Luiz Roberto; Malta, Deborah Carvalho; Gomes, Grace Angélica de Oliveira; Bracco, Mário M; Florindo, Alex Antonio; Mielke, Gregore Iven; Parra, Diana C; Lobelo, Felipe; Simoes, Eduardo J; Hallal, Pedro Curi

2014-01-01

OBJECTIVE Assessment of prevalence of health promotion programs in primary health care units within Brazil’s health system. METHODS We conducted a cross-sectional descriptive study based on telephone interviews with managers of primary care units. Of a total 42,486 primary health care units listed in the Brazilian Unified Health System directory, 1,600 were randomly selected. Care units from all five Brazilian macroregions were selected proportionally to the number of units in each region. We examined whether any of the following five different types of health promotion programs was available: physical activity; smoking cessation; cessation of alcohol and illicit drug use; healthy eating; and healthy environment. Information was collected on the kinds of activities offered and the status of implementation of the Family Health Strategy at the units. RESULTS Most units (62.0%) reported having in place three health promotion programs or more and only 3.0% reported having none. Healthy environment (77.0%) and healthy eating (72.0%) programs were the most widely available; smoking and alcohol use cessation were reported in 54.0% and 42.0% of the units. Physical activity programs were offered in less than 40.0% of the units and their availability varied greatly nationwide, from 51.0% in the Southeast to as low as 21.0% in the North. The Family Health Strategy was implemented in most units (61.0%); however, they did not offer more health promotion programs than others did. CONCLUSIONS Our study showed that most primary care units have in place health promotion programs. Public policies are needed to strengthen primary care services and improve training of health providers to meet the goals of the agenda for health promotion in Brazil. PMID:25372175

Diagnostic Accuracy of the Primary Care Screener for Affective Disorder (PC-SAD) in Primary Care.

PubMed

Picardi, Angelo; Adler, D A; Rogers, W H; Lega, I; Zerella, M P; Matteucci, G; Tarsitani, L; Caredda, M; Gigantesco, A; Biondi, M

2013-01-01

Depression goes often unrecognised and untreated in non-psychiatric medical settings. Screening has recently gained acceptance as a first step towards improving depression recognition and management. The Primary Care Screener for Affective Disorders (PC-SAD) is a self-administered questionnaire to screen for Major Depressive Disorder (MDD) and Dysthymic Disorder (Dys) which has a sophisticated scoring algorithm that confers several advantages. This study tested its performance against a 'gold standard' diagnostic interview in primary care. A total of 416 adults attending 13 urban general internal medicine primary care practices completed the PC-SAD. Of 409 who returned a valid PC-SAD, all those scoring positive (N=151) and a random sample (N=106) of those scoring negative were selected for a 3-month telephone follow-up assessment including the administration of the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I) by a psychiatrist who was masked to PC-SAD results. Most selected patients (N=212) took part in the follow-up assessment. After adjustment for partial verification bias the sensitivity, specificity, positive and negative predictive value for MDD were 90%, 83%, 51%, and 98%. For Dys, the corresponding figures were 78%, 79%, 8%, and 88%. While some study limitations suggest caution in interpreting our results, this study corroborated the diagnostic validity of the PC-SAD, although the low PPV may limit its usefulness with regard to Dys. Given its good psychometric properties and the short average administration time, the PC-SAD might be the screening instrument of choice in settings where the technology for computer automated scoring is available.

Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial.

PubMed

Staedke, Sarah G; Maiteki-Sebuguzi, Catherine; Rehman, Andrea M; Kigozi, Simon P; Gonahasa, Samuel; Okiring, Jaffer; Lindsay, Steve W; Kamya, Moses R; Chandler, Clare I R; Dorsey, Grant; Drakeley, Chris

2018-06-01

Intermittent preventive treatment (IPT) is a well established malaria control intervention. Evidence that delivering IPT to schoolchildren could provide community-level benefits is limited. We did a cluster-randomised controlled trial to assess the effect of IPT of primary schoolchildren with dihydroartemisinin-piperaquine (DP) on indicators of malaria transmission in the community, in Jinja, Uganda. We included 84 clusters, each comprising one primary school and the 100 closest available households. The clusters were randomly assigned 1:1 to receive IPT with DP or standard care (control) by restricted randomisation to ensure balance by geography and school type. Children in intervention schools received IPT monthly for up to six rounds (June to December, 2014). We did cross-sectional community surveys in randomly selected households at baseline and in January to April, 2015, during which we measured participants' temperatures and obtained finger-prick blood smears for measurement of parasite prevalence by microscopy. We also did entomological surveys 1 night per month in households from 20 randomly selected IPT and 20 control clusters. The primary trial outcome was parasite prevalence in the final community survey. The primary entomological survey outcome was the annual entomological inoculation rate (aEIR) from July, 2014, to April, 2015. This trial is registered at ClinicalTrials.gov, number NCT02009215. Among 23 280 students registered in the 42 intervention schools, 10 079 (43%) aged 5-20 years were enrolled and received at least one dose of DP. 9286 (92%) of 10 079 received at least one full course of DP (three doses). Community-level parasite prevalence was lower in the intervention clusters than in the control clusters (19% vs 23%, adjusted risk ratio 0·85, 95% CI 0·73-1·00, p=0·05). The aEIR was lower in the intervention group than in the control group, but not significantly so (10·1 vs 15·2 infective bites per person, adjusted incidence rate ratio 0·80, 95% CI 0·36-1·80, p=0·59). IPT of schoolchildren with DP might have a positive effect on community-level malaria indicators and be operationally feasible. Studies with greater IPT coverage are needed. UK Medical Research Council, UK Department for International Development, and Wellcome Trust. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Management of diabetes by primary health care nurses in Auckland, New Zealand.

PubMed

Daly, Barbara; Arroll, Bruce; Kenealy, Timothy; Sheridan, Nicolette; Scragg, Robert

2015-03-01

The increasing prevalence of diabetes has led to expanded roles for primary health care nurses in diabetes management. To describe and compare anthropometric and glycaemic characteristics of patients with diabetes and their management by practice nurses, district nurses and specialist nurses. Primary health care nurses in Auckland randomly sampled in a cross-sectional survey, completed a postal self-administered questionnaire (n=284) and telephone interview (n=287) between 2006 and 2008. Biographical and diabetes management details were collected for 265 (86%) of the total 308 patients with diabetes seen by participants on a randomly selected day. Nurses were able to access key clinical information for only a proportion of their patients: weight for 68%; BMI for 16%; HbA1c for 76% and serum glucose levels for 34% (for either measure 82%); although most (96%) records were available about whether patients self-monitored blood glucose levels. Most nursing management activities focused on giving advice on dietary intake (70%) and physical activity (66%), weighing patients (58%), and testing or discussing blood glucose levels (42% and 43%, respectively). These proportions varied by nurse group (p<0.05), generally being highest for specialist nurses and lowest for district nurses. Most practice and specialist nurses could access patients' weight and HbA1c levels and focused their clinical management on health education to decrease these if indicated. Communication and organisational systems and contracts that allow district nurses to work across both primary and secondary health services are necessary to improve community-based nursing services for patients with diabetes.

Prevalence of attention deficit hyperactivity disorder and comorbid psychiatric and behavioral problems among primary school students in western Saudi Arabia

PubMed Central

AlZaben, Faten N.; Sehlo, Mohammad G.; Alghamdi, Waleed A.; Tayeb, Haythum O.; Khalifa, Doaa A.; Mira, Abdulrahman T.; Alshuaibi, Abdulaziz M.; Alguthmi, Mosab A.; Derham, Ahmad A.; Koenig, Harold G.

2018-01-01

Objectives: To determine the prevalence of attention deficit hyperactivity disorder (ADHD), subtypes of ADHD, and psychiatric, academic, and behavioral comorbidity in public primary school students in Jeddah, Saudi Arabia. Methods: This is a cross-sectional study. A simple random sample of 6 primary government schools in Jeddah, Saudi Arabia, was identified (3 male, 3 female), and a random sample of classes in each of grades 1-6 were selected. Between July and November 2016, teachers in these classes were asked to complete the Vanderbilt ADHD scale on all students in their classes. Results: A total of 929 students were screened. The overall prevalence of ADHD was 5% (5.3% in girls, 4.7% in boys). The most prevalent subtype of ADHD was combined type (2.7%), followed by hyperactive type (1.2%), and inattentive type (1.1%). The highest prevalence of ADHD overall was in grade 3 (7.1%) and the lowest prevalence in grade 6 (3.4%). Among students with ADHD, prevalence of comorbid psychiatric, academic, and behavioral problems was widespread (56.5% oppositional defiant disorder/conduct disorder, 54.4% impaired academic performance, 44.4% classroom behavioral problems, 41.3% depression/anxiety). Comorbid problems were especially prevalent in combined ADHD subtype and in boys. Conclusions: Attention deficit hyperactivity disorder is common in primary school children in Jeddah, and is associated with widespread psychiatric, academic, and behavioral problems, especially in boys. These findings have implications for the diagnosis and treatment of this serious neurobehavioral disorder. PMID:29332109

Nano-hydroxyapatite and calcium-enriched mixture for pulp capping of sound primary teeth: a randomized clinical trial.

PubMed

Haghgoo, Roza; Asgary, Saeed; Mashhadi Abbas, Fatemeh; Montazeri Hedeshi, Roshanak

2015-01-01

Nano-hydroxyapatite (NHA) has been used for regeneration of osseous defects. Calcium-enriched mixture (CEM) cement is also used for various dental treatments. This trial compared the efficacy of NHA and CEM cement for direct pulp capping (DPC) of sound primary teeth. In this randomized clinical trial with split-mouth design, after attaining informed consent, 20 sound primary canines scheduled for orthodontic extraction, were selected. After mechanical pulp exposure, the exposed site was capped with either NHA or CEM cement and then immediately restored with glass-ionomer and resin composite. The teeth were extracted after two months and examined histologically. Parameters of hard tissue bridge (HTB) formation, its type and quality as well as pulpal inflammation scores were compared between the two experimental groups. The data were analyzed using the Mann Whitney U and Fisher's exact test. The level of significance was set at 0.001. All CEM specimens showed inflammation score of 0 (less than 10%). However, in NHA group, inflammation scores of 0 (less than 10%), 1 (10%-30%) and 2 (30%-50%) were observed in 2 (20%), 4 (40%) and 4 (40%) specimens, respectively (P<0.001). HTB was formed in all CEM specimens while it was developed in 2 specimens of NHA (20%; P<0.001). All CEM specimens showed normal pulp; only two cases in NHA group (20%) demonstrated uninflamed normal pulp. CEM cement was superior to NHA as a DPC agent in terms of HTB formation and pulp inflammation scores. It is a suitable material for the DPC of primary teeth.

Neuro-Compatible Metabolic Glycan Labeling of Primary Hippocampal Neurons in Noncontact, Sandwich-Type Neuron-Astrocyte Coculture.

PubMed

Choi, Ji Yu; Park, Matthew; Cho, Hyeoncheol; Kim, Mi-Hee; Kang, Kyungtae; Choi, Insung S

2017-12-20

Glycans are intimately involved in several facets of neuronal development and neuropathology. However, the metabolic labeling of surface glycans in primary neurons is a difficult task because of the neurotoxicity of unnatural monosaccharides that are used as a metabolic precursor, hindering the progress of metabolic engineering in neuron-related fields. Therefore, in this paper, we report a neurosupportive, neuron-astrocyte coculture system that neutralizes the neurotoxic effects of unnatural monosaccharides, allowing for the long-term observation and characterization of glycans in primary neurons in vitro. Polysialic acids in neurons are selectively imaged, via the metabolic labeling of sialoglycans with peracetylated N-azidoacetyl-d-mannosamine (Ac 4 ManNAz), for up to 21 DIV. Two-color labeling shows that neuronal activities, such as neurite outgrowth and recycling of membrane components, are highly dynamic and change over time during development. In addition, the insertion sites of membrane components are suggested to not be random, but be predominantly localized in developing neurites. This work provides a new research platform and also suggests advanced 3D systems for metabolic-labeling studies of glycans in primary neurons.

A double-blind, placebo-controlled study of edivoxetine as an adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment.

PubMed

Ball, Susan; Dellva, Mary Anne; D'Souza, Deborah N; Marangell, Lauren B; Russell, James M; Goldberger, Celine

2014-01-01

This phase 2 study examined the efficacy and tolerability of edivoxetine, a highly selective norepinephrine reuptake inhibitor, as an adjunctive treatment for patients with major depressive disorder (MDD) who have a partial response to selective serotonin reuptake inhibitor (SSRI) treatment. Study design consisted of double-blind, 10-week therapy of adjunctive edivoxetine (6-18 mg once daily) or adjunctive placebo with SSRI. Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression (HAMD17) total score ≥16. The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Safety measures included treatment-emergent adverse events (TEAE) and vital signs. For the primary evaluable population (n=63 for adjunctive edivoxetine and n=68 for adjunctive placebo), the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score; the effect size of edivoxetine treatment was 0.26. Significant treatment differences, favoring adjunctive edivoxetine (p≤.05), were shown for improvements in role functioning and the functional impact of fatigue. For the adjunctive edivoxetine randomized group (N=111), the most frequent TEAEs were hyperhidrosis (7.2%), nausea (7.2%), erectile dysfunction (6.3%) and testicular pain (6.3%). Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups. Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome. For patients with MDD who had a partial response to SSRIs, adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure. However, pending further study, improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression. Copyright © 2014 Elsevier B.V. All rights reserved.

Efficacy of low interatrial septum and right atrial appendage pacing for prevention of permanent atrial fibrillation in patients with sinus node disease: results from the electrophysiology-guided pacing site selection (EPASS) study.

PubMed

Verlato, Roberto; Botto, Giovanni Luca; Massa, Riccardo; Amellone, Claudia; Perucca, Antonello; Bongiorni, Maria Grazia; Bertaglia, Emanuele; Ziacchi, Vigilio; Piacenti, Marcello; Del Rosso, Attilio; Russo, Giovanni; Baccillieri, Maria Stella; Turrini, Pietro; Corbucci, Giorgio

2011-12-01

The role of pacing sites and atrial electrophysiology on the progression of atrial fibrillation (AF) to the permanent form in patients with sinus node dysfunction (SND) has never been investigated. The aim of the study was to investigate the relationship between atrial electrophysiology and the efficacy of atrial pacing at the low interatrial septum (IAS) or at the right atrial appendage (RAA) to prevent persistent/permanent AF in patients with SND. The Electrophysiology-Guided Pacing Site Selection (EPASS) Study was a prospective, controlled, randomized study. Atrial refractoriness, basal and incremental conduction times from the RAA to the coronary sinus ostium were measured before implantation, and the difference (ΔCTos) was calculated. Patients with ΔCTos ≥ 50 ms (study group) and those with ΔCTos <50 ms (control group) were randomly assigned to RAA or IAS with algorithms for continuous atrial stimulation "on." The primary end point was time to development of permanent or persistent AF within a 2-year follow-up in the study group, IAS versus RAA. Data were analyzed by intention to treat. One hundred two patients (77 ± 7 years, 44 mol/L) were enrolled, 69 (68%) in the study group and 33 (32%) in the control group. Of these, 97 ended the study, respectively, randomly assigned: 29 IAS versus 36 RAA and 18 IAS versus 14 RAA. After a mean follow-up of 15 ± 7 (median, 17) months, 11 (16.6%) patients in the study group met the primary end point: 2 IAS versus 9 RAA (log rank=3.93, P=0.047). In patients with SND and intra-atrial conduction delay, low IAS pacing was superior to RAA pacing in preventing progression to persistent or permanent AF. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239226.

Antihypertensive effect of Iranian Crataegus curvisepala Lind.: a randomized, double-blind study.

PubMed

Asgary, S; Naderi, G H; Sadeghi, M; Kelishadi, R; Amiri, M

2004-01-01

The aim of the present study was to investigate the potential antihypertensive effects of extracts of the flavonoid-rich Iranian flower, Crataegus curvisepala Lind., a member of the Rosaceae family. The hydroalcoholic extract of the leaves and flowers were studied in a double-blind, placebo-controlled clinical trial to determine its effects. A total of 92 men and women with primary mild hypertension, aged 40-60 years, were selected and divided randomly into two groups, receiving either hydroalcoholic extract of C. curvisepala Lind. or placebo three times daily for more than 4 months. Blood pressure (BP) was measured each month. Statistical analysis was carried out using Student's t-test. The results obtained showed a significant decrease in both systolic and diastolic BP after 3 months (p < 0.05). C. curvisepala has a time-dependent antihypertensive effect.

A financial analysis of maxillomandibular fixation versus rigid internal fixation for treatment of mandibular fractures.

PubMed

Schmidt, B L; Kearns, G; Gordon, N; Kaban, L B

2000-11-01

The aim of this study was to compare the cost-effectiveness of mandibular fracture treatment by closed reduction with maxillomandibular fixation (CRF) with open reduction and rigid internal fixation (ORIF). This was a retrospective study of 85 patients admitted to the Oral and Maxillofacial Surgery Service at San Francisco General Hospital and treated for mandibular fractures from January 1 to December 31, 1993. The patients were divided into 2 groups: 1) those treated with CRF and 2) those treated with ORIF. The outcome variables were length of hospital stay, duration of anesthesia, and time in operating room. The charge for primary fracture treatment included the fees for the operation and hospitalization without any complications. Within the group of 85 patients treated for mandibular fractures in 1993, 10 patients treated with CRF and 10 patients treated with ORIF were randomly selected, and hospital billing statements were used to estimate the average charge of primary treatment. The average charge to manage a major postoperative infection also was estimated based on the billing statements of 10 randomly selected patients treated in 1992 (5 treated with CRF, 5 with ORIF) who required hospital admission for the management of a complication. The average total charge was computed by using the average charge for primary treatment plus the incidence of postoperative infection multiplied by the average charge for management of that complication. Eighty-five patients were included in the study. The average charge for primary treatment was $10,100 for the CRF group and $28,362 for the ORIF group. The average charge for the inpatient management of a major postoperative infection was $26,671 for the CRF group and $39,213 for the ORIF group. The average total charge for management of a mandible fracture with CRF was $10,927; the total charge for the ORIF group was $34,636. The results of this retrospective study suggest that the use of CRF in the management of mandibular fractures at our institution provides considerable savings over treatment by using ORIF. The use of ORIF should be reserved for patients and fracture types with specific indications.

The impact of ethics and work-related factors on nurse practitioners' and physician assistants' views on quality of primary healthcare in the United States

PubMed Central

Ulrich, Connie M.; Zhou, Qiuping (Pearl); Hanlon, Alexandra; Danis, Marion; Grady, Christine

2016-01-01

Purpose Nurse practitioners (NPs) and physician assistants (PAs) provide primary care services for many American patients. Ethical knowledge is foundational to resolving challenging practice issues, yet little is known about the importance of ethics and work-related factors in the delivery of quality care. The aim of this study was to quantitatively assess whether the quality of the care that practitioners deliver is influenced by ethics and work-related factors. Methods This paper is a secondary data analysis of a cross-sectional self-administered mailed survey of 1,371 primary care NPs and PAs randomly selected from primary care and primary care subspecialties in the United States. Results Ethics preparedness and confidence were significantly associated with perceived quality of care (p < 0.01) as were work-related characteristics such as percentage of patients with Medicare and Medicaid, patient demands, physician collegiality, and practice autonomy (p < 0.01). Forty-four percent of the variance in quality of care was explained by these factors. Conclusions Investing in ethics education and addressing restrictive practice environments may improve collaborative practice, teamwork, and quality of care. PMID:24613597

Quality of life in Chinese patients with schizophrenia treated in primary care.

PubMed

Li, Yan; Hou, Cai-Lan; Ma, Xin-Rong; Zhong, Bao-Liang; Zang, Yu; Jia, Fu-Jun; Lin, Yong-Qiang; Lai, Kelly Y C; Chiu, Helen F K; Ungvari, Gabor S; Hall, Brian J; Cai, Mei-Ying; Ng, Chee H; Xiang, Yu-Tao

2017-08-01

In China, maintenance treatment for clinically stable patients with schizophrenia is usually provided by primary care physicians. This study examined the quality of life (QOL) in patients with schizophrenia treated in primary care and explored the demographic and clinical characteristics associated with QOL. Altogether, 612 patients with schizophrenia treated in 22 randomly selected primary care services in China formed the study sample. QOL, psychotic and depressive symptoms, extra-pyramidal symptoms and insight were assessed using standardized instruments. Data analyses were conducted with the one sample t-test and multiple linear regression analyses. Compared with the normative data for the Chinese general population, significantly lower scores in physical and mental QOL domains were found in the patient group. Older age, being unemployed, major medical conditions, no smoking, more severe depressive and negative symptoms, more frequent insomnia, and suicidality were independently associated with poor physical QOL. Male gender, more severe depressive and anxiety symptoms, more frequent insomnia, and suicidality were independently associated with poor mental QOL. Patients with schizophrenia treated in primary care had lower level of QOL in comparison with general population. Effective measures need to be implemented to improve their QOL. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

The impact of ethics and work-related factors on nurse practitioners' and physician assistants' views on quality of primary healthcare in the United States.

PubMed

Ulrich, Connie M; Zhou, Qiuping Pearl; Hanlon, Alexandra; Danis, Marion; Grady, Christine

2014-08-01

Nurse practitioners (NPs) and physician assistants (PAs) provide primary care services for many American patients. Ethical knowledge is foundational to resolving challenging practice issues, yet little is known about the importance of ethics and work-related factors in the delivery of quality care. The aim of this study was to quantitatively assess whether the quality of the care that practitioners deliver is influenced by ethics and work-related factors. This paper is a secondary data analysis of a cross-sectional self-administered mailed survey of 1,371 primary care NPs and PAs randomly selected from primary care and primary care subspecialties in the United States. Ethics preparedness and confidence were significantly associated with perceived quality of care (p<0.01) as were work-related characteristics such as percentage of patients with Medicare and Medicaid, patient demands, physician collegiality, and practice autonomy (p<0.01). Forty-four percent of the variance in quality of care was explained by these factors. Investing in ethics education and addressing restrictive practice environments may improve collaborative practice, teamwork, and quality of care. Copyright © 2014 Elsevier Inc. All rights reserved.

Barriers for dental treatment of primary teeth in East and West Germany.

PubMed

Splieth, Christian H; Bünger, Bianka; Pine, Cynthia

2009-03-01

In many countries, restorative treatment in primary teeth is suboptimal. Thus, this study tried to detect barriers for dentists to restore primary teeth in kindergarten children (3-6 years). For a representative survey, 320 dentists (184 West, 136 East Germany) were randomly selected from the dental associations' registers and asked to answer a questionnaire on their profile, their view of the National Health System, and possible barriers for restoring primary teeth. The analysis (response rate 57.7%) showed that the parents were no barrier and the dentists felt the need of restoring primary teeth. In addition to the children's anxiety, the inadequate reimbursement for fillings were perceived as clear barrier. The comparison of West and East German dentists detected statistically significantly higher barriers in West Germany, where - in contrast to the German Democratic Republic - no structured training in paediatric dentistry was compulsory before unification. Only 35% of the East German dentists rated restorative treatment in 3- to 6-year-olds as stressful in contrast to 65% in West Germany, where especially male dentists found no time to treat children. This study reveals that dentists can also be a considerable barrier to restorative treatment in small children, especially without adequate training in dental schools.

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

PubMed

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

2017-11-01

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

Metabolic Syndrome as a Cardiovascular Disease Risk Factor: Patients Evaluated in Primary Care

PubMed Central

Cabré, Joan-Josep; Martín, Francisco; Costa, Bernardo; Piñol, Josep L; Llor, Josep L; Ortega, Yolanda; Basora, Josep; Baldrich, Marta; Solà, Rosa; Daniel, Jordi; Hernández, Josep Ma; Saumell, Judit; Bladé, Jordi; Sagarra, Ramon; Basora, Teresa; Montañés, Dolors; Frigola, Joan L; Donado-Mazarrón, Angel; García-Vidal, Maria Teresa; Sánchez-Oro, Isabel; de Magriñà, Josep M; Urbaneja, Ana; Barrio, Francisco; Vizcaíno, Jesús; Sabaté, Josep M; Pascual, Irene; Revuelta, Vanesa

2008-01-01

To estimate the prevalence of metabolic syndrome (MS) in a population receiving attention in primary care centers (PCC) we selected a random cohort of ostensibly normal subjects from the registers of 5 basic-health area (BHA) PCC. Diagnosis of MS was with the WHO, NCEP and IDF criteria. Variables recorded were: socio-demographic data, CVD risk factors including lipids, obesity, diabetes, blood pressure and smoking habit and a glucose tolerance test outcome. Of the 720 individuals selected (age 60.3 ± 11.5 years), 431 were female, 352 hypertensive, 142 diabetic, 233 pre-diabetic, 285 obese, 209 dyslipemic and 106 smokers. CVD risk according to the Framingham and REGICOR calculation was 13.8 ± 10% and 8.8 ± 9.8%, respectively. Using the WHO, NCEP and IDF criteria, MS was diagnosed in 166, 210 and 252 subjects, respectively and the relative risk of CVD complications in MS subjects was 2.56. Logistic regression analysis indicated that the MS components (WHO set), the MS components (IDF set) and the female gender had an increased odds ratio for CVD of 3.48 (95CI%: 2.26–5.37), 2.28 (95%CI: 1.84–4.90) and 2.26 (95%CI: 1.48–3.47), respectively. We conclude that MS and concomitant CVD risk is high in ostensibly normal population attending primary care clinics, and this would necessarily impinge on resource allocation in primary care. PMID:18647383

Prevalence of contagious mastitis pathogens in bulk tank milk in Québec

PubMed Central

Francoz, David; Bergeron, Luc; Nadeau, Marie; Beauchamp, Guy

2012-01-01

The objective of this study was to estimate the prevalence of mycoplasma, Staphylococcus aureus, and Streptococcus agalactiae in bulk tank milk (BTM) in Québec dairy herds. BTM was sampled 3 times a month in 117 randomly selected dairy herds. Samples were submitted for S. aureus, S. agalactiae, and mycoplasma and for direct mycoplasma detection by polymerase chain reaction (PCR). Mycoplasma spp. was identified at least once in 3 herds (2.6%) by primary culture and/or PCR and in 4 herds (3.4%) by enrichment culture and/or PCR. Staphylococcus aureus was isolated at least once in 99 (84.6%) and 112 (95.7%) herds in primary culture and after enrichment, respectively. Streptococcus agalactiae was isolated at least once in 9 (7.7%) and 10 (8.6%) herds in primary culture and after enrichment, respectively. Herd prevalence of mycoplasma was similar to that previously reported in Canada. Staphylococcus aureus is still by far the most important contagious mastitis pathogen. PMID:23543925

Pediculosis capitis among primary-school children in Mafraq Governorate, Jordan.

PubMed

AlBashtawy, M; Hasna, F

2012-01-01

Pediculosis capitis (head lice infestation) is a worldwide public health concern affecting mostly primary-school children. In a cross-sectional study in 2009/2010, the prevalence of pediculosis capitis and some risk factors for infestation were investigated among 1550 randomly selected primary-school children in Mafraq governorate, Jordan. The prevalence of pediculosis capitis was 26.6%. There were significant differences in the prevalence between girls (34.7%) and boys (19.6%), rural (31.2%) and urban (23.5%) residents, and history of infestation in the previous year (57.4%) versus no history (11.5%), as well as between children of different ages, family size and income (P<0.001). Longer hair length, lack of bathing facilities, low frequency of hair-washing and bathing, and sharing of articles (e.g. combs, scarves) were significantly associated with infestation (P<0.001). The prevalence of infestation was higher than reported in previous studies in Jordan (< 14%). Programmes are needed to increase awareness of pediculosis capitis and the importance of good personal hygiene.

Electronic Health Records and Information Portability: A Pilot Study in a Rural Primary Healthcare Center in India

PubMed Central

Radhakrishna, Kedar; Goud, B. Ramakrishna; Kasthuri, Arvind; Waghmare, Abijeet; Raj, Tony

2014-01-01

Clinical documentation and health information portability pose unique challenges in urban and rural areas of India. This article presents findings of a pilot study conducted in a primary health center in rural India. In this article, we focus on primary care in rural India and how a portable health record system could facilitate the availability of medical information at the point of care. We followed a geriatric cohort and a maternal cohort of 308 participants over a nine-month period. Physician encounters were entered into a web-based electronic health record. This information was made available to all study participants through a short messaging service (SMS). Additionally, 135 randomly selected participants from the cohort were issued a USB-based memory card that contained their detailed health records and could be viewed on most computers. The dual portability model implemented in the pilot study demonstrates the utility of the concept. PMID:25214819

Patient views on reminder letters for influenza vaccinations in an older primary care patient population: a mixed methods study.

PubMed

Anderson, Kelly K; Sebaldt, Rolf J; Lohfeld, Lynne; Karwalajtys, Tina; Ismaila, Afisi S; Goeree, Ron; Donald, Faith C; Burgess, Ken; Kaczorowski, Janusz

2008-01-01

To explore the perspectives of older adults on the acceptability of reminder letters for influenza vaccinations. We randomly selected 23 family physicians from each Family Health and Primary Care network participating in a demonstration project designed to increase the delivery of preventive services in Ontario. From the roster of each physician, we surveyed 35 randomly selected patients over 65 years of age who recently received a reminder letter regarding influenza vaccinations from their physician. The questionnaires sought patient perspectives on the acceptability and usefulness of the letter. We also conducted follow-up telephone interviews with a subgroup of respondents to explore some of the survey findings in greater depth. 85.3% (663/767) of patients completed the questionnaire. Sixty-five percent of respondents recalled receiving the reminder (n=431), and of those, 77.3% found it helpful. Of the respondents who recalled the letter and received a flu shot (n=348), 11.2% indicated they might not have done so without the letter. The majority of respondents reported that they would like to continue receiving reminder letters for influenza vaccinations (63.0%) and other preventive services (77.1%) from their family physician. The interview participants endorsed the use of reminder letters for improving vaccination coverage in older adults, but did not feel that the strategy was required for them personally. The general attitude of older adults towards reminder letters was favourable, and the reminders appear to have contributed to a modest increase in influenza vaccination rates.

Full central neurokinin-1 receptor blockade is required for efficacy in depression: evidence from orvepitant clinical studies.

PubMed

Ratti, Emiliangelo; Bettica, Paolo; Alexander, Robert; Archer, Graeme; Carpenter, David; Evoniuk, Gary; Gomeni, Roberto; Lawson, Erica; Lopez, Monica; Millns, Helen; Rabiner, Eugenii A; Trist, David; Trower, Michael; Zamuner, Stefano; Krishnan, Ranga; Fava, Maurizio

2013-05-01

Full, persistent blockade of central neurokinin-1 (NK1) receptors may be a potential antidepressant mechanism. The selective NK1 antagonist orvepitant (GW823296) was used to test this hypothesis. A preliminary positron emission tomography study in eight male volunteers drove dose selection for two randomized six week studies in patients with major depressive disorder (MDD). Displacement of central [(11)C]GR205171 binding indicated that oral orvepitant doses of 30-60 mg/day provided >99% receptor occupancy for ≥24 h. Studies 733 and 833 randomized patients with MDD and 17-item Hamilton Depression Rating Scale (HAM-D)≥22 to double-blind treatment with orvepitant 30 mg/day, orvepitant 60 mg/day or placebo (1:1:1). Primary outcome measure was change from baseline in 17-item HAM-D total score at Week 6 analyzed using mixed models repeated measures. Study 733 (n=328) demonstrated efficacy on the primary endpoint (estimated drug-placebo differences of 30 mg: -2.41, 95% confidence interval (CI) (-4.50 to -0.31) p=0.0245; 60 mg: -2.86, 95% CI (-4.97 to -0.75) p=0.0082). Study 833 (n=345) did not show significance (estimated drug-placebo differences of 30 mg: -1.67, 95% CI (-3.73 to 0.39) p=0.1122; 60 mg: -0.76, 95% CI (-2.85 to 1.32) p=0.4713). The results support the hypothesis that full, long lasting blockade of central NK1 receptors may be an efficacious mechanism for the treatment of MDD.

Perception and use of massive open online courses among medical students in a developing country: multicentre cross-sectional study

PubMed Central

Aboshady, Omar A; Radwan, Ahmed E; Eltaweel, Asmaa R; Azzam, Ahmed; Aboelnaga, Amr A; Hashem, Heba A; Darwish, Salma Y; Salah, Rehab; Kotb, Omar N; Afifi, Ahmed M; Noaman, Aya M; Salem, Dalal S; Hassouna, Ahmed

2015-01-01

Objectives To assess the prevalence of awareness and use of massive open online courses (MOOCs) among medical undergraduates in Egypt as a developing country, as well as identifying the limitations and satisfaction of using these courses. Design A multicentre, cross-sectional study using a web-based, pilot-tested and self-administered questionnaire. Settings Ten out of 19 randomly selected medical schools in Egypt. Participants 2700 undergraduate medical students were randomly selected, with an equal allocation of participants in each university and each study year. Primary and secondary outcome measures Primary outcome measures were the percentages of students who knew about MOOCs, students who enrolled and students who obtained a certificate. Secondary outcome measures included the limitations and satisfaction of using MOOCs through five-point Likert scale questions. Results Of 2527 eligible students, 2106 completed the questionnaire (response rate 83.3%). Of these students, 456 (21.7%) knew the term MOOCs or websites providing these courses. Out of the latter, 136 (29.8%) students had enrolled in at least one course, but only 25 (18.4%) had completed courses earning certificates. Clinical year students showed significantly higher rates of knowledge (p=0.009) and enrolment (p<0.001) than academic year students. The primary reasons for the failure of completion of courses included lack of time (105; 77.2%) and slow Internet speed (73; 53.7%). Regarding the 25 students who completed courses, 21 (84%) were satisfied with the overall experience. However, there was less satisfaction regarding student–instructor (8; 32%) and student–student (5; 20%) interactions. Conclusions About one-fifth of Egyptian medical undergraduates have heard about MOOCs with only about 6.5% actively enrolled in courses. Students who actively participated showed a positive attitude towards the experience, but better time-management skills and faster Internet connection speeds are required. Further studies are needed to survey the enrolled students for a better understanding of their experience. PMID:25564149

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.

PubMed

Maron, David J; Hochman, Judith S; O'Brien, Sean M; Reynolds, Harmony R; Boden, William E; Stone, Gregg W; Bangalore, Sripal; Spertus, John A; Mark, Daniel B; Alexander, Karen P; Shaw, Leslee; Berger, Jeffrey S; Ferguson, T Bruce; Williams, David O; Harrington, Robert A; Rosenberg, Yves

2018-07-01

Prior trials comparing a strategy of optimal medical therapy with or without revascularization have not shown that revascularization reduces cardiovascular events in patients with stable ischemic heart disease (SIHD). However, those trials only included participants in whom coronary anatomy was known prior to randomization and did not include sufficient numbers of participants with significant ischemia. It remains unknown whether a routine invasive approach offers incremental value over a conservative approach with catheterization reserved for failure of medical therapy in patients with moderate or severe ischemia. The ISCHEMIA trial is a National Heart, Lung, and Blood Institute supported trial, designed to compare an initial invasive or conservative treatment strategy for managing SIHD patients with moderate or severe ischemia on stress testing. Five thousand one-hundred seventy-nine participants have been randomized. Key exclusion criteria included estimated glomerular filtration rate (eGFR) <30 mL/min, recent myocardial infarction (MI), left ventricular ejection fraction <35%, left main stenosis >50%, or unacceptable angina at baseline. Most enrolled participants with normal renal function first underwent blinded coronary computed tomography angiography (CCTA) to exclude those with left main coronary artery disease (CAD) and without obstructive CAD. All randomized participants receive secondary prevention that includes lifestyle advice and pharmacologic interventions referred to as optimal medical therapy (OMT). Participants randomized to the invasive strategy underwent routine cardiac catheterization followed by revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery, when feasible, as selected by the local Heart Team to achieve optimal revascularization. Participants randomized to the conservative strategy undergo cardiac catheterization only for failure of OMT. The primary endpoint is a composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest. Assuming the primary endpoint will occur in 16% of the conservative group within 4 years, estimated power exceeds 80% to detect an 18.5% reduction in the primary endpoint. Major secondary endpoints include the composite of CV death and nonfatal MI, net clinical benefit (primary and secondary endpoints combined with stroke), angina-related symptoms and disease-specific quality of life, as well as a cost-effectiveness assessment in North American participants. Ancillary studies of patients with advanced chronic kidney disease and those with documented ischemia and non-obstructive coronary artery disease are being conducted concurrently. ISCHEMIA will provide new scientific evidence regarding whether an invasive management strategy improves clinical outcomes when added to optimal medical therapy in patients with SIHD and moderate or severe ischemia. Copyright © 2018 Elsevier Inc. All rights reserved.

Selecting promising treatments in randomized Phase II cancer trials with an active control.

PubMed

Cheung, Ying Kuen

2009-01-01

The primary objective of Phase II cancer trials is to evaluate the potential efficacy of a new regimen in terms of its antitumor activity in a given type of cancer. Due to advances in oncology therapeutics and heterogeneity in the patient population, such evaluation can be interpreted objectively only in the presence of a prospective control group of an active standard treatment. This paper deals with the design problem of Phase II selection trials in which several experimental regimens are compared to an active control, with an objective to identify an experimental arm that is more effective than the control or to declare futility if no such treatment exists. Conducting a multi-arm randomized selection trial is a useful strategy to prioritize experimental treatments for further testing when many candidates are available, but the sample size required in such a trial with an active control could raise feasibility concerns. In this study, we extend the sequential probability ratio test for normal observations to the multi-arm selection setting. The proposed methods, allowing frequent interim monitoring, offer high likelihood of early trial termination, and as such enhance enrollment feasibility. The termination and selection criteria have closed form solutions and are easy to compute with respect to any given set of error constraints. The proposed methods are applied to design a selection trial in which combinations of sorafenib and erlotinib are compared to a control group in patients with non-small-cell lung cancer using a continuous endpoint of change in tumor size. The operating characteristics of the proposed methods are compared to that of a single-stage design via simulations: The sample size requirement is reduced substantially and is feasible at an early stage of drug development.

Modified Angle's Classification for Primary Dentition.

PubMed

Chandranee, Kaushik Narendra; Chandranee, Narendra Jayantilal; Nagpal, Devendra; Lamba, Gagandeep; Choudhari, Purva; Hotwani, Kavita

2017-01-01

This study aims to propose a modification of Angle's classification for primary dentition and to assess its applicability in children from Central India, Nagpur. Modification in Angle's classification has been proposed for application in primary dentition. Small roman numbers i/ii/iii are used for primary dentition notation to represent Angle's Class I/II/III molar relationships as in permanent dentition, respectively. To assess applicability of modified Angle's classification a cross-sectional preschool 2000 children population from central India; 3-6 years of age residing in Nagpur metropolitan city of Maharashtra state were selected randomly as per the inclusion and exclusion criteria. Majority 93.35% children were found to have bilateral Class i followed by 2.5% bilateral Class ii and 0.2% bilateral half cusp Class iii molar relationships as per the modified Angle's classification for primary dentition. About 3.75% children had various combinations of Class ii relationships and 0.2% children were having Class iii subdivision relationship. Modification of Angle's classification for application in primary dentition has been proposed. A cross-sectional investigation using new classification revealed various 6.25% Class ii and 0.4% Class iii molar relationships cases in preschool children population in a metropolitan city of Nagpur. Application of the modified Angle's classification to other population groups is warranted to validate its routine application in clinical pediatric dentistry.

Using Maximum Entropy to Find Patterns in Genomes

NASA Astrophysics Data System (ADS)

Liu, Sophia; Hockenberry, Adam; Lancichinetti, Andrea; Jewett, Michael; Amaral, Luis

The existence of over- and under-represented sequence motifs in genomes provides evidence of selective evolutionary pressures on biological mechanisms such as transcription, translation, ligand-substrate binding, and host immunity. To accurately identify motifs and other genome-scale patterns of interest, it is essential to be able to generate accurate null models that are appropriate for the sequences under study. There are currently no tools available that allow users to create random coding sequences with specified amino acid composition and GC content. Using the principle of maximum entropy, we developed a method that generates unbiased random sequences with pre-specified amino acid and GC content. Our method is the simplest way to obtain maximally unbiased random sequences that are subject to GC usage and primary amino acid sequence constraints. This approach can also be easily be expanded to create unbiased random sequences that incorporate more complicated constraints such as individual nucleotide usage or even di-nucleotide frequencies. The ability to generate correctly specified null models will allow researchers to accurately identify sequence motifs which will lead to a better understanding of biological processes. National Institute of General Medical Science, Northwestern University Presidential Fellowship, National Science Foundation, David and Lucile Packard Foundation, Camille Dreyfus Teacher Scholar Award.

Feasibility of an obesity intervention for paediatric primary care targeting parenting and children: Helping HAND.

PubMed

O'Connor, T M; Hilmers, A; Watson, K; Baranowski, T; Giardino, A P

2013-01-01

  The primary care setting offers the opportunity to reach children and parents to encourage healthy lifestyle behaviours, and improve weight status among children.   Test the feasibility of Helping HAND (Healthy Activity and Nutrition Directions), an obesity intervention for 5- to 8-year-old children in primary care clinics.   A randomized controlled pilot study of Helping HAND, a 6-month intervention, targeted children with body mass index 85-99%tile and their parents. Intervention group attended monthly sessions and self-selected child behaviours and parenting practices to change. Control group received regular paediatric care and was wait-listed for Helping HAND. Session completion, participant satisfaction, child anthropometrics, dietary intake, physical activity, TV viewing and behaviour-specific parenting practices were measured pre and post intervention.   Forty parent-child dyads enrolled: 82.5% were Hispanic, 80% had a girl and 65% reported income ≤ $30, 000/year. There was 20% attrition from Helping HAND (attended <4/6 sessions). Families self-selected 4.35 (SD 1.75) behaviours to target during the 6-month programme and each of the seven behaviours was selected by 45-80% of the families. There were no between group differences in the child's body mass index z-score, dietary intake or physical activity post intervention. Intervention group viewed 14.9 (SE 2.3) h/week of TV post intervention versus control group 23.3 (SE 2.4) h/week (P < 0.05).   Helping HAND is feasible, due to low attrition, good programme attendance, and clinically relevant improvements in some child and parenting behaviours. © 2011 Blackwell Publishing Ltd.

A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

PubMed Central

Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

2013-01-01

Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty followed by stent placement is feasible. The immediate procedural outcomes with primary angioplasty are comparable to stent placement and warrant further studies. PMID:24358415

Primary School Teachers' Understanding of Science Process Skills in Relation to Their Teaching Qualifications and Teaching Experience

NASA Astrophysics Data System (ADS)

Shahali, Edy H. M.; Halim, Lilia; Treagust, David F.; Won, Mihye; Chandrasegaran, A. L.

2017-04-01

This study investigated the understanding of science process skills (SPS) of 329 science teachers from 52 primary schools selected by random sampling. The understanding of SPS was measured in terms of conceptual and operational aspects of SPS using an instrument called the Science Process Skills Questionnaire (SPSQ) with a Cronbach's alpha reliability of 0.88. The findings showed that the teachers' conceptual understanding of SPS was much weaker than their practical application of SPS. The teachers' understanding of SPS differed by their teaching qualifications but not so much by their teaching experience. Emphasis needs to be given to both conceptual and operational understanding of SPS during pre-service and in-service teacher education to enable science teachers to use the skills and implement inquiry-based lessons in schools.

Influences of human and livestock density on winter habitat selection of Mongolian gazelle (Procapra gutturosa).

PubMed

Luo, Zhenhua; Liu, Bingwan; Liu, Songtao; Jiang, Zhigang; Halbrook, Richard S

2014-01-01

Human and livestock related disturbances of habitat selection by ungulates are topics of global concern, as they have profound impacts on ungulate survival, population density, fitness, and management; however, differences in ungulate habitat use under different human and livestock densities are not fully understood. Mongolian gazelle (Procapra gutturosa), an endemic ungulate species on the Asia-European steppe, faces varying intensities of human and livestock disturbances in the area around Dalai Lake, China. To investigate how habitat selection strategies vary as disturbance intensity changes, we randomly set 20 transects containing 1486 plots, on which we conducted repeated surveys of 21 ecological factors during the winters in the period of 2005-2008. We aimed to: 1) determine the critical factors underlying habitat selection of the gazelles; 2) determine the gazelles' habitat preferences in this area; 3) determine how habitat selection varies with disturbance intensity and explore the primary underlying mechanism. We used binary-logistic regressions and information theoretic approaches to build best-fit habitat selection models, and calculated resource selection functions. Sixty-six herds, 522 individuals, and 499 tracks were recorded. Our results indicate that snow depth and aboveground biomass are the main factors affecting habitat selection by Mongolian gazelle throughout the district in winter. Thin snow cover and abundant aboveground biomass are preferred. Avoiding disturbance was the primary factor accounting for habitat selection in low disturbance areas, although with increasing human or live-stock-related disturbance, gazelle maintained a reduced distance to the source of the disturbance. Presumably owing to that shift, movement costs were more important as disturbance increased. In addition, Mongolian gazelle selected habitats based on topographical features promoting greater visibility where disturbance was lower. We suggest several management implications of our findings for this ungulate species will contribute to the effective conservation of Mongolian gazelle in the Dalai Lake area.

'On Your Feet to Earn Your Seat', a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial.

PubMed

Gardner, Benjamin; Thuné-Boyle, Ingela; Iliffe, Steve; Fox, Kenneth R; Jefferis, Barbara J; Hamer, Mark; Tyler, Nick; Wardle, Jane

2014-09-20

Many older adults are both highly sedentary (that is, spend considerable amounts of time sitting) and physically inactive (that is, do little physical activity). This protocol describes an exploratory trial of a theory-based behaviour change intervention in the form of a booklet outlining simple activities ('tips') designed both to reduce sedentary behaviour and to increase physical activity in older adults. The intervention is based on the 'habit formation' model, which proposes that consistent repetition leads to behaviour becoming automatic, sustaining activity gains over time. The intervention is being developed iteratively, in line with Medical Research Council complex intervention guidelines. Selection of activity tips was informed by semi-structured interviews and focus groups with older adults, and input from a multidisciplinary expert panel. An ongoing preliminary field test of acceptability among 25 older adults will inform further refinement. An exploratory randomized controlled trial will be conducted within a primary care setting, comparing the tips booklet with a control fact sheet. Retired, inactive and sedentary adults (n = 120) aged 60 to 74 years, with no physical impairments precluding light physical activity, will be recruited from general practices in north London, UK. The primary outcomes are recruitment and attrition rates. Secondary outcomes are changes in behaviour, habit, health and wellbeing over 12 weeks. Data will be used to inform study procedures for a future, larger-scale definitive randomized controlled trial. Current Controlled Trials ISRCTN47901994.

Raloxifene for women with Alzheimer disease

PubMed Central

Ala, Tom; Sainani, Kristin L.; Bernstein, Allan L.; Stephenson, B. Sue; Rosen, Allyson C.; Farlow, Martin R.

2015-01-01

Objective: To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect. Methods: This pilot study was conducted as a randomized, double-blind, placebo-controlled trial, with a planned treatment of 12 months. Women with late-onset AD of mild to moderate severity were randomly allocated to high-dose (120 mg) oral raloxifene or identical placebo provided once daily. The primary outcome compared between treatment groups at 12 months was change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog). Results: Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68–84), and 39 women contributed 12-month outcomes. ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval −0.39 to 0.44, 2-tailed p = 0.89). Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score. Caregiver burden and caregiver distress were similar in both groups. Conclusions: Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group. Classification of evidence: This study provides Class I evidence that for women with AD, raloxifene does not have a significant cognitive effect. The study lacked the precision to exclude a small effect. PMID:26537053

Treatment of Non-neurogenic Overactive Bladder with OnabotulinumtoxinA: Systematic Review and Meta-analysis of Prospective, Randomized, Placebo-controlled Clinical Trials.

PubMed

Arruda, Raquel Martins; Takano, Claudia Cristina; Girão, Manoel João Batista Castelo; Haddad, Jorge Milhem; Aleixo, Gabriel Francisco; Castro, Rodrigo Aquino

2018-04-01

We performed a systematic review and meta-analysis of randomized placebo-controlled trials that studied non-neurogenic overactive bladder patients who were treated with 100 units of onabotulinumtoxinA or placebo. The primary purpose of our study was to evaluate the clinical effectiveness with regard to urinary urgency, urinary frequency, nocturia, and incontinence episodes. Our secondary purpose consisted of evaluating the adverse effects. Our initial search yielded 532 entries. Of these, seven studies met all the inclusion criteria (prospective, randomized, placebo-controlled studies, ≥ 3 points on the Jadad scale) and were selected for analysis. For all primary endpoints, the toxin was more effective than placebo ( p  < 0.0001; 95% confidence interval [95CI]), namely: urgency (mean difference = -2.07; 95CI = [-2.55-1.58]), voiding frequency (mean difference = -1.64; 95CI = [-2.10-1.18]), nocturia (mean difference = -0.25; 95CI = [-0.39-0.11]) and incontinence episodes (mean difference = -2.06; 95CI= [-2.60-1.52]). The need for intermittent catheterization and the occurrence of urinary tract infection (UTI) were more frequent in patients treated with onabotulinumtoxinA than in patients treated with placebo ( p  < 0.0001). Compared with placebo, onabotulinumtoxinA had significantly and clinically relevant reductions in overactive bladder symptoms and is associated with higher incidence of intermittent catheterization and UTI. Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil.

Healthy together Victoria and childhood obesity-a methodology for measuring changes in childhood obesity in response to a community-based, whole of system cluster randomized control trial.

PubMed

Strugnell, Claudia; Millar, Lynne; Churchill, Andrew; Jacka, Felice; Bell, Colin; Malakellis, Mary; Swinburn, Boyd; Allender, Steve

2016-01-01

Healthy Together Victoria (HTV) - a complex 'whole of system' intervention, including an embedded cluster randomized control trial, to reduce chronic disease by addressing risk factors (physical inactivity, poor diet quality, smoking and harmful alcohol use) among children and adults in selected communities in Victoria, Australia (Healthy Together Communities). To describe the methodology for: 1) assessing changes in the prevalence of measured childhood obesity and associated risks between primary and secondary school students in HTV communities, compared with comparison communities; and 2) assessing community-level system changes that influence childhood obesity in HTC and comparison communities. Twenty-four geographically bounded areas were randomized to either prevention or comparison (2012). A repeat cross-sectional study utilising opt-out consent will collect objectively measured height, weight, waist and self-reported behavioral data among primary [Grade 4 (aged 9-10y) and Grade 6 (aged 11-12y)] and secondary [Grade 8 (aged 13-14y) and Grade 10 (aged 15-16y)] school students (2014 to 2018). Relationships between measured childhood obesity and system causes, as defined in the Foresight obesity systems map, will be assessed using a range of routine and customised data. This research methodology describes the beginnings of a state-wide childhood obesity monitoring system that can evolve to regularly inform progress on reducing obesity, and situate these changes in the context of broader community-level system change.

Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

PubMed

Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

2016-04-15

A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease.

PubMed

Ostrowitzki, Susanne; Lasser, Robert A; Dorflinger, Ernest; Scheltens, Philip; Barkhof, Frederik; Nikolcheva, Tania; Ashford, Elizabeth; Retout, Sylvie; Hofmann, Carsten; Delmar, Paul; Klein, Gregory; Andjelkovic, Mirjana; Dubois, Bruno; Boada, Mercè; Blennow, Kaj; Santarelli, Luca; Fontoura, Paulo

2017-12-08

Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD). In this randomized, double-blind, placebo-controlled phase III study, we investigated gantenerumab over 2 years. Patients were randomized to gantenerumab 105 mg or 225 mg or placebo every 4 weeks by subcutaneous injection. The primary endpoint was the change from baseline to week 104 in Clinical Dementia Rating Sum of Boxes (CDR-SB) score. We evaluated treatment effects on cerebrospinal fluid biomarkers (all patients) and amyloid positron emission tomography (substudy). A futility analysis was performed once 50% of patients completed 2 years of treatment. Safety was assessed in patients who received at least one dose. Of the 3089 patients screened, 797 were randomized. The study was halted early for futility; dosing was discontinued; and the study was unblinded. No differences between groups in the primary (least squares mean [95% CI] CDR-SB change from baseline 1.60 [1.28, 1.91], 1.69 [1.37, 2.01], and 1.73 [1.42, 2.04] for placebo, gantenerumab 105 mg, and gantenerumab 225 mg, respectively) or secondary clinical endpoints were observed. The incidence of generally asymptomatic amyloid-related imaging abnormalities increased in a dose- and APOE ε4 genotype-dependent manner. Exploratory analyses suggested a dose-dependent drug effect on clinical and biomarker endpoints. The study was stopped early for futility, but dose-dependent effects observed in exploratory analyses on select clinical and biomarker endpoints suggest that higher dosing with gantenerumab may be necessary to achieve clinical efficacy. ClinicalTrials.gov, NCT01224106 . Registered on October 14, 2010.

Transcatheter Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Darmoch, Fahed; Al-Khadra, Yasser; Soud, Mohamad; Fanari, Zaher; Alraies, M Chadi

2018-01-01

Patent foramen ovale (PFO) with atrial septal aneurysm is suggested as an important potential source for cryptogenic strokes. Percutaneous PFO closure to reduce the recurrence of stroke compared to medical therapy has been intensely debated. The aim of this study is to assess whether PFO closure in patients with cryptogenic stroke is safe and effective compared with medical therapy. A search of PubMed, Medline, and Cochrane Central Register from January 2000 through September 2017 for randomized controlled trails (RCT), which compared PFO closure to medical therapy in patients with cryptogenic stroke was conducted. We used the items "PFO or patent foramen ovale", "paradoxical embolism", "PFO closure" and "stroke". Data were pooled for the primary outcome measure using the random-effects model as pooled rate ratio (RR). The primary outcome was reduction in recurrent strokes. Among 282 studies, 5 were selected. Our analysis included 3,440 patients (mean age 45 years, 55% men, mean follow-up 2.9 years), 1,829 in the PFO closure group and 1,611 in the medical therapy group. The I2 heterogeneity test was found to be 48%. A random effects model combining the results of the included studies demonstrated a statistically significant risk reduction in risk of recurrent stroke in the PFO closure group when compared with medical therapy (RR 0.42; 95% CI 0.20-0.91, p = 0.03). Pooled data from 5 large RCTs showed that PFO closure in patients with cryptogenic stroke is safe and effective intervention for prevention of stroke recurrence compared with medical therapy. © 2018 S. Karger AG, Basel.

Organizational interventions improving access to community-based primary health care for vulnerable populations: a scoping review.

PubMed

Khanassov, Vladimir; Pluye, Pierre; Descoteaux, Sarah; Haggerty, Jeannie L; Russell, Grant; Gunn, Jane; Levesque, Jean-Frederic

2016-10-10

Access to community-based primary health care (hereafter, 'primary care') is a priority in many countries. Health care systems have emphasized policies that help the community 'get the right service in the right place at the right time'. However, little is known about organizational interventions in primary care that are aimed to improve access for populations in situations of vulnerability (e.g., socioeconomically disadvantaged) and how successful they are. The purpose of this scoping review was to map the existing evidence on organizational interventions that improve access to primary care services for vulnerable populations. Scoping review followed an iterative process. Eligibility criteria: organizational interventions in Organisation for Economic Cooperation and Development (OECD) countries; aiming to improve access to primary care for vulnerable populations; all study designs; published from 2000 in English or French; reporting at least one outcome (avoidable hospitalization, emergency department admission, or unmet health care needs). Main bibliographic databases (Medline, Embase, CINAHL) and team members' personal files. One researcher selected relevant abstracts and full text papers. Theory-driven synthesis: The researcher classified included studies using (i) the 'Patient Centered Access to Healthcare' conceptual framework (dimensions and outcomes of access to primary care), and (ii) the classification of interventions of the Cochrane Effective Practice and Organization of Care. Using pattern analysis, interventions were mapped in accordance with the presence/absence of 'dimension-outcome' patterns. Out of 8,694 records (title/abstract), 39 studies with varying designs were included. The analysis revealed the following pattern. Results of 10 studies on interventions classified as 'Formal integration of services' suggested that these interventions were associated with three dimensions of access (approachability, availability and affordability) and reduction of hospitalizations (four/four studies), emergency department admissions (six/six studies), and unmet healthcare needs (five/six studies). These 10 studies included seven non-randomized studies, one randomized controlled trial, one quantitative descriptive study, and one mixed methods study. Our results suggest the limited breadth of research in this area, and that it will be feasible to conduct a full systematic review of studies on the effectiveness of the formal integration of services to improve access to primary care services for vulnerable populations.

Strategy to recognize and initiate treatment of chronic heart failure in primary care (STRETCH): a cluster randomized trial.

PubMed

van Riet, Evelien E S; Hoes, Arno W; Limburg, Alexander; van der Hoeven, Henk; Landman, Marcel A J; Rutten, Frans H

2014-01-08

Most patients with heart failure are diagnosed and managed in primary care, however, underdiagnosis and undertreatment are common. We assessed whether implementation of a diagnostic-therapeutic strategy improves functionality, health-related quality of life, and uptake of heart failure medication in primary care. A selective screening study followed by a single-blind cluster randomized trial in primary care. The study population consists of patients aged 65 years or over who presented themselves to the general practitioner in the previous 12 months with shortness of breath on exertion. Patients already known with established heart failure, confirmed by echocardiography, are excluded. Diagnostic investigations include history taking, physical examination, electrocardiography, and serum N-terminal pro B-type natriuretic peptide levels. Only participants with an abnormal electrocardiogram or an N-terminal pro B-type natriuretic peptide level exceeding the exclusionary cutpoint for non-acute onset heart failure (> 15 pmol/L (≈ 125 pg/ml)) will undergo open-access echocardiography. The diagnosis of heart failure (with reduced or preserved ejection fraction) is established by an expert panel consisting of two cardiologists and a general practitioner, according to the criteria of the European Society of Cardiology guidelines.Patients with newly established heart failure are allocated to either the 'care as usual' group or the 'intervention' group. Randomization is at the level of the general practitioner. In the intervention group general practitioners receive a single half-day training in heart failure management and the use of a structured up-titration scheme. All participants fill out quality of life questionnaires at baseline and after six months of follow-up. A six-minute walking test will be performed in patients with heart failure. Information on medication and hospitalization rates is extracted from the electronic medical files of the general practitioners. This study will provide information on the prevalence of unrecognized heart failure in elderly with shortness of breath on exertion, and the randomized comparison will reveal whether management based on a half-day training of general practitioners in the practical application of an up-titration scheme results in improvements in functionality, health-related quality of life, and uptake of heart failure medication in heart failure patients compared to care as usual. ClinicalTrials.gov NCT01202006.

COMPARISON OF RANDOM AND SYSTEMATIC SITE SELECTION FOR ASSESSING ATTAINMENT OF AQUATIC LIFE USES IN SEGMENTS OF THE OHIO RIVER

EPA Science Inventory

This report is a description of field work and data analysis results comparing a design comparable to systematic site selection with one based on random selection of sites. The report is expected to validate the use of random site selection in the bioassessment program for the O...

The Good School Toolkit for reducing physical violence from school staff to primary school students: a cluster-randomised controlled trial in Uganda.

PubMed

Devries, Karen M; Knight, Louise; Child, Jennifer C; Mirembe, Angel; Nakuti, Janet; Jones, Rebecca; Sturgess, Joanna; Allen, Elizabeth; Kyegombe, Nambusi; Parkes, Jenny; Walakira, Eddy; Elbourne, Diana; Watts, Charlotte; Naker, Dipak

2015-07-01

Violence against children from school staff is widespread in various settings, but few interventions address this. We tested whether the Good School Toolkit-a complex behavioural intervention designed by Ugandan not-for-profit organisation Raising Voices-could reduce physical violence from school staff to Ugandan primary school children. We randomly selected 42 primary schools (clusters) from 151 schools in Luwero District, Uganda, with more than 40 primary 5 students and no existing governance interventions. All schools agreed to be enrolled. All students in primary 5, 6, and 7 (approximate ages 11-14 years) and all staff members who spoke either English or Luganda and could provide informed consent were eligible for participation in cross-sectional baseline and endline surveys in June-July 2012 and 2014, respectively. We randomly assigned 21 schools to receive the Good School Toolkit and 21 to a waitlisted control group in September, 2012. The intervention was implemented from September, 2012, to April, 2014. Owing to the nature of the intervention, it was not possible to mask assignment. The primary outcome, assessed in 2014, was past week physical violence from school staff, measured by students' self-reports using the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. Analyses were by intention to treat, and are adjusted for clustering within schools and for baseline school-level means of continuous outcomes. The trial is registered at clinicaltrials.gov, NCT01678846. No schools left the study. At 18-month follow-up, 3820 (92·4%) of 4138 randomly sampled students participated in a cross-sectional survey. Prevalence of past week physical violence was lower in the intervention schools (595/1921, 31·0%) than in the control schools (924/1899, 48·7%; odds ratio 0·40, 95% CI 0·26-0·64, p<0·0001). No adverse events related to the intervention were detected, but 434 children were referred to child protective services because of what they disclosed in the follow-up survey. The Good School Toolkit is an effective intervention to reduce violence against children from school staff in Ugandan primary schools. MRC, DfID, Wellcome Trust, Hewlett Foundation. Copyright © 2015 Devries et al. Open access article published under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

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

ERIC Educational Resources Information Center

Wagler, Amy; Wagler, Ron

2014-01-01

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

Discovery of an artificial peptide agonist to the fibroblast growth factor receptor 1c/βKlotho complex from random peptide T7 phage display.

PubMed

Sakamoto, Kotaro; Kawata, Yayoi; Masuda, Yasushi; Umemoto, Tadashi; Ito, Takashi; Asami, Taiji; Takekawa, Shiro; Ohtaki, Tetsuya; Inooka, Hiroshi

2016-11-04

Fibroblast growth factor receptor-1c (FGFR1c)/βKlotho (KLB) complex is a receptor of fibroblast growth factor 21 (FGF21). Pharmacologically, FGF21 shows anti-obesity and anti-diabetic effects upon peripheral administration. Here, we report the development of an artificial peptide agonist to the FGFR1c/KLB heterodimer complex. The peptide, F91-8A07 (LPGRTCREYPDLWWVRCY), was discovered from random peptide T7 phage display and selectively bound to the FGFR1c/KLB complex, but not to FGFR1c and KLB individually. After subsequent peptide dimerization using a short polyethyleneglycol (PEG) linker, the dimeric F91-8A07 peptide showed higher potent agonist activity than that of FGF21 in cultured primary human adipocytes. Moreover, the dimeric peptide led to an expression of the early growth response protein-1 (Egr-1) mRNA in vivo, which is a target gene of FGFR1c. To the best of our knowledge, this is the first report of a FGFR1c/KLB complex-selective artificial peptide agonist. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Meta-analysis of selective serotonin reuptake inhibitors in patients with depression and coronary heart disease.

PubMed

Pizzi, Carmine; Rutjes, Anne Wilhelmina Saskia; Costa, Grazia Maria; Fontana, Fiorella; Mezzetti, Andrea; Manzoli, Lamberto

2011-04-01

The occurrence of depression in patients with coronary heart disease (CHD) substantially increases the likelihood of a poorer cardiovascular prognosis. Although antidepressants are generally effective in decreasing depression, their use in patients with CHD is controversial. We carried out a meta-analysis to evaluate the health effects of selective serotonin reuptake inhibitors (SSRIs) versus placebo or no antidepressants in patients with CHD and depression. Observational studies and randomized controlled trials (RCTs) were searched in MEDLINE, EMBASE, PsycINFO, Cochrane Controlled Clinical Trial Register and other trial registries, and references of relevant articles. Primary outcomes were readmission for CHD (including myocardial infarction, unstable angina, and stroke) and all-cause mortality; the secondary outcome was severity of depression symptoms. Seven articles on 6 RCTs involving 2,461 participants were included. One study incorrectly randomized participants, and another was a reanalysis of RCT data. These were considered observational and analyzed separately. When only properly randomized trials were considered (n = 734 patients), patients on SSRIs showed no significant differences in mortality (risk ratio 0.39, 95% confidence interval 0.08 to 2.01) or CHD readmission rates (0.74, 0.44 to 1.23) compared to controls. Conversely, when all studies were included, SSRI use was associated with a significant decrease in CHD readmission (0.63, 0.46 to 0.86) and mortality rates (0.56, 0.35 to 0.88). A significantly greater improvement in depression symptoms was always apparent in patients on SSRIs with all selected indicators. In conclusion, in patients with CHD and depression, SSRI medication decreases depression symptoms and may improve CHD prognosis. Crown Copyright © 2011. Published by Elsevier Inc. All rights reserved.

Public perspectives on nuclear security. US national security surveys, 1993--1997

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

Herron, K.G.; Jenkins-Smith, H.C.

This is the third report in a series of studies to examine how US attitudes about nuclear security are evolving in the post-Cold War era and to identify trends in public perceptions and preferences relevant to the evolution of US nuclear security policy. It presents findings from three surveys: a nationwide telephone survey of randomly selected members of the US general public; a written survey of randomly selected members of American Men and Women of Science; and a written survey of randomly selected state legislators from all fifty US states. Key areas of investigation included nuclear security, cooperation between USmore » and Russian scientists about nuclear issues, vulnerabilities of critical US infrastructures and responsibilities for their protection, and broad areas of US national science policy. While international and US national security were seen to be slowly improving, the primary nuclear threat to the US was perceived to have shifted from Russia to China. Support was found for nuclear arms control measures, including mutual reductions in stockpiles. However, respondents were pessimistic about eliminating nuclear armaments, and nuclear deterrence continued to be highly values. Participants favored decreasing funding f/or developing and testing new nuclear weapons, but supported increased investments in nuclear weapons infrastructure. Strong concerns were expressed about nuclear proliferation and the potential for nuclear terrorism. Support was evident for US scientific cooperation with Russia to strengthen security of Russian nuclear assets. Elite and general public perceptions of external and domestic nuclear weapons risks and external and domestic nuclear weapons benefits were statistically significantly related to nuclear weapons policy options and investment preferences. Demographic variables and individual belief systems were systematically related both to risk and benefit perceptions and to policy and spending preferences.« less

Selenium- or vitamin E-related gene variants, interaction with supplementation, and risk of high-grade prostate cancer in SELECT

PubMed Central

Chan, June M.; Darke, Amy K.; Penney, Kathryn L.; Tangen, Catherine M.; Goodman, Phyllis J.; Lee, Gwo-Shu Mary; Sun, Tong; Peisch, Sam; Tinianow, Alex M.; Rae, James M.; Klein, Eric A.; Thompson, Ian M.

2016-01-01

Background Epidemiological studies and secondary analyses of randomized trials supported the hypothesis that selenium and vitamin E lower prostate cancer risk. However, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) showed no benefit of either supplement. Genetic variants involved in selenium or vitamin E metabolism or transport may underlie the complex associations of selenium and vitamin E. Methods We undertook a case-cohort study of SELECT participants randomized to placebo, selenium or vitamin E. The subcohort included 1,434 men; our primary outcome was high-grade prostate cancer (N=278 cases, Gleason 7 or higher cancer). We used weighted Cox regression to examine the association between SNPs and high-grade prostate cancer risk. To assess effect modification, we created interaction terms between randomization arm and genotype and calculated log likelihood statistics. Results We noted statistically significant (p<0.05) interactions between selenium assignment, SNPs in CAT, SOD2, PRDX6, SOD3, and TXNRD2 and high-grade prostate cancer risk. Statistically significant SNPs that modified the association of vitamin E assignment and high-grade prostate cancer included SEC14L2, SOD1, and TTPA. In the placebo arm, several SNPs, hypothesized to interact with supplement assignment and risk of high-grade prostate cancer, were also directly associated with outcome. Conclusion Variants in selenium and vitamin E metabolism/transport genes may influence risk of overall and high-grade prostate cancer, and may modify an individual man’s response to vitamin E or selenium supplementation with regards to these risks. Impact The effect of selenium or vitamin E supplementation on high-grade prostate cancer risk may vary by genotype. PMID:27197287

Traumatic dental injuries to primary incisors and the terminal or occlusal plane relationship in Indian preschool children.

PubMed

Shekhar, M G; Mohan, R

2011-03-01

To determine the prevalence of traumatic dental injuries to primary incisors in 3-5 year-old preschool children and to study the relationship between dental injuries and age, gender and terminal plane relation. A cross-sectional study was conducted in 1,126 preschool children aged three to five years enrolled in eleven private and public nursery schools, randomly selected in Chennai, India. Data regarding the age, gender, cause and type of trauma and terminal plane relation were recorded. Maxillary and mandibular primary incisors were examined for traumatic injuries and were recorded according to the method described by Andreasen & Andreasen (1994). Data were analyzed through descriptive analysis and chi-square test. Traumatic injuries to primary incisors were identified in 6.2% of children. No significant gender differences in prevalence were seen (p > 0.05). Enamel fractures (57.3%) dominated amongst the type of injuries. Majority of children who sustained traumatic dental injuries to their primary incisors were associated with mesial step molar relation. Mesial step molar relation may be considered one of the possible predisposing factors to trauma in primary dentition. Further, there is need to intensify oral health education targeted at both parents and teachers at nursery schools to inform them about consequences of primary teeth injuries on permanent dentition and emphasize the importance of prevention of dental injuries in children.

Efficacy of Ginger for Alleviating the Symptoms of Primary Dysmenorrhea: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

PubMed

Daily, James W; Zhang, Xin; Kim, Da Sol; Park, Sunmin

2015-12-01

There has been no attempt to date to synthesize the available evidence for the efficacy of ginger for treating primary dysmenorrhea. This systematic review evaluates the current evidence for the effectiveness of ginger for treating primary dysmenorrhea. Literature searches were conducted using 12 electronic databases including PubMed, EMBASE, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were: "ginger" or "Zingiber officinale" and "dysmenorrhea" and "pain." Studies using ginger as a treatment of primary dysmenorrhea were considered for inclusion. The major outcome of primary dysmenorrhea was assessed using a pain visual analogue score (PVAS). Initial searches yielded 29 articles. Of these original results, seven met specific selection criteria. Four of the RCTs compared the therapeutic efficacy of ginger with a placebo during the first 3-4 days of the menstrual cycle and were included in the meta analysis. The meta-analysis of these data showed a significant effect of ginger in reducing PVAS in subjects having primary dysmenorrhea (risk ratio, -1.85; 95% CI of -2.87, -0.84, P = 0.0003). Six RCTs out of 7 exhibited low to moderate of risk of bias. Collectively these RCTs provide suggestive evidence for the effectiveness of 750-2000 mg ginger powder during the first 3-4 days of menstrual cycle for primary dysmenorrhea. Wiley Periodicals, Inc.

Does Implant Design Affect Implant Primary Stability? A Resonance Frequency Analysis-Based Randomized Split-Mouth Clinical Trial.

PubMed

Gehrke, Sergio Alexandre; da Silva, Ulisses Tavares; Del Fabbro, Massimo

2015-12-01

The purpose of this study was to assess implant stability in relation to implant design (conical vs. semiconical and wide-pitch vs narrow-pitch) using resonance frequency analysis. Twenty patients with bilateral edentulous maxillary premolar region were selected. In one hemiarch, conical implants with wide pitch (group 1) were installed; in the other hemiarch, semiconical implants with narrow pitch were installed (group 2). The implant allocation was randomized. The implant stability quotient (ISQ) was measured by resonance frequency analysis immediately following implant placement to assess primary stability (time 1) and at 90 days after placement (time 2). In group 1, the mean and standard deviation ISQ for time 1 was 65.8 ± 6.22 (95% confidence interval [CI], 55 to 80), and for time 2, it was 68.0 ± 5.52 (95% CI, 57 to 77). In group 2, the mean and standard deviation ISQ was 63.6 ± 5.95 (95% CI, 52 to 78) for time 1 and 67.0 ± 5.71 (95% CI, 58 to 78) for time 2. The statistical analysis demonstrated significant difference in the ISQ values between groups at time 1 (P = .007) and no statistical difference at time 2 (P = .54). The greater primary stability of conical implants with wide pitch compared with semiconical implants with narrow pitch might suggest a preference for the former in case of the adoption of immediate or early loading protocols.

Impact of an academic-community partnership in medical education on community health: evaluation of a novel student-based home visitation program.

PubMed

Rock, John A; Acuña, Juan M; Lozano, Juan Manuel; Martinez, Iveris L; Greer, Pedro J; Brown, David R; Brewster, Luther; Simpson, Joe L

2014-04-01

Current US healthcare delivery systems do not adequately address healthcare demands. Physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes. Home visitation is an effective method for changing health outcomes in some populations. The Florida International University Herbert Wertheim College of Medicine Green Family Foundation NeighborhoodHELP service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs. We performed a prospective evaluation of 330 households randomly assigned to one of two groups: visitation from a student team (intervention group) or limited intervention (control group). The program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition. All of the households were surveyed at baseline and after 1 year of participation in the study. After 1 year in the program and after adjustment for confounders, intervention group households proved more likely (P ≤ 0.05) than control households to have undergone physical examinations, blood pressure monitoring, and cervical cytology screenings. Cholesterol screenings and mammograms were borderline significant (P = 0.05 and P = 0.06, respectively). This study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures. The study underscores the important role interprofessional student teams may play in improving the health of US communities, while students concurrently learn about primary prevention and primary care.

Indirect language therapy for children with persistent language impairment in mainstream primary schools: outcomes from a cohort intervention.

PubMed

McCartney, Elspeth; Boyle, James; Ellis, Sue; Bannatyne, Susan; Turnbull, Mary

2011-01-01

A manualized language therapy developed via a randomized controlled trial had proved efficacious in the short-term in developing expressive language for mainstream primary school children with persistent language impairment. This therapy had been delivered to a predetermined schedule by speech and language therapists or speech and language therapy assistants to children individually or in groups. However, this model of service delivery is no longer the most common model in UK schools, where indirect consultancy approaches with intervention delivered by school staff are often used. A cohort study was undertaken to investigate whether the therapy was equally efficacious when delivered to comparable children by school staff, rather than speech and language therapists or speech and language therapy assistants. Children in the cohort study were selected using the same criteria as in the randomized controlled trial, and the same manualized therapy was used, but delivered by mainstream school staff using a consultancy model common in the UK. Outcomes were compared with those of randomized controlled trial participants. The gains in expressive language measured in the randomized controlled trial were not replicated in the cohort study. Less language-learning activity was recorded than had been planned, and less than was delivered in the randomized controlled trial. Implications for 'consultancy' speech and language therapist service delivery models in mainstream schools are outlined. At present, the more efficacious therapy is that delivered by speech and language therapists or speech and language therapy assistants to children individually or in groups. This may be related to more faithful adherence to the interventions schedule, and to a probably greater amount of language-learning activity undertaken. Intervention delivered via school-based 'consultancy' approaches in schools will require to be carefully monitored by schools and SLT services. © 2010 Royal College of Speech & Language Therapists.

Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial.

PubMed

Perrin, Ellen C; Sheldrick, R Christopher; McMenamy, Jannette M; Henson, Brandi S; Carter, Alice S

2014-01-01

Disruptive behavior disorders, such as attention-deficient/hyperactivity disorder and oppositional defiant disorder, are common and stable throughout childhood. These disorders cause long-term morbidity but benefit from early intervention. While symptoms are often evident before preschool, few children receive appropriate treatment during this period. Group parent training, such as the Incredible Years program, has been shown to be effective in improving parenting strategies and reducing children's disruptive behaviors. Because they already monitor young children's behavior and development, primary care pediatricians are in a good position to intervene early when indicated. To investigate the feasibility and effectiveness of parent-training groups delivered to parents of toddlers in pediatric primary care settings. This randomized clinical trial was conducted at 11 diverse pediatric practices in the Greater Boston area. A total of 273 parents of children between 2 and 4 years old who acknowledged disruptive behaviors on a 20-item checklist were included. A 10-week Incredible Years parent-training group co-led by a research clinician and a pediatric staff member. Self-reports and structured videotaped observations of parent and child behaviors conducted prior to, immediately after, and 12 months after the intervention. A total of 150 parents were randomly assigned to the intervention or the waiting-list group. An additional 123 parents were assigned to receive intervention without a randomly selected comparison group. Compared with the waiting-list group, greater improvement was observed in both intervention groups (P < .05). No differences were observed between the randomized and the nonrandomized intervention groups. Self-reports and structured observations provided evidence of improvements in parenting practices and child disruptive behaviors that were attributable to participation in the Incredible Years groups. This study demonstrated the feasibility and effectiveness of parent-training groups conducted in pediatric office settings to reduce disruptive behavior in toddlers. clinicaltrials.gov Identifier: NCT00402857.

A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial.

PubMed

Piccini, Jonathan P; Connolly, Stuart J; Abraham, William T; Healey, Jeff S; Steinberg, Benjamin A; Al-Khalidi, Hussein R; Dignacco, Patricia; van Veldhuisen, Dirk J; Sauer, William H; White, Michel; Wilton, Stephen B; Anand, Inder S; Dufton, Christopher; Marshall, Debra A; Aleong, Ryan G; Davis, Gordon W; Clark, Richard L; Emery, Laura L; Bristow, Michael R

2018-05-01

Few therapies are available for the safe and effective treatment of atrial fibrillation (AF) in patients with heart failure. Bucindolol is a non-selective beta-blocker with mild vasodilator activity previously found to have accentuated antiarrhythmic effects and increased efficacy for preventing heart failure events in patients homozygous for the major allele of the ADRB1 Arg389Gly polymorphism (ADRB1 Arg389Arg genotype). The safety and efficacy of bucindolol for the prevention of AF or atrial flutter (AFL) in these patients has not been proven in randomized trials. The Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Metoprolol Succinate for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure (GENETIC-AF) trial is a multicenter, randomized, double-blinded "seamless" phase 2B/3 trial of bucindolol hydrochloride versus metoprolol succinate, for the prevention of symptomatic AF/AFL in patients with reduced ejection fraction heart failure (HFrEF). Patients with pre-existing HFrEF and recent history of symptomatic AF are eligible for enrollment and genotype screening, and if they are ADRB1 Arg389Arg, eligible for randomization. A total of approximately 200 patients will comprise the phase 2B component and if pre-trial assumptions are met, 620 patients will be randomized at approximately 135 sites to form the Phase 3 population. The primary endpoint is the time to recurrence of symptomatic AF/AFL or mortality over a 24-week follow-up period, and the trial will continue until 330 primary endpoints have occurred. GENETIC-AF is the first randomized trial of pharmacogenetic guided rhythm control, and will test the safety and efficacy of bucindolol compared with metoprolol succinate for the prevention of recurrent symptomatic AF/AFL in patients with HFrEF and an ADRB1 Arg389Arg genotype. (ClinicalTrials.govNCT01970501). Copyright © 2017 Elsevier Inc. All rights reserved.

Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?

PubMed

Als-Nielsen, Bodil; Chen, Wendong; Gluud, Christian; Kjaergard, Lise L

2003-08-20

Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions. To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events. Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication). Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not. The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; chi2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events. Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.

Feasibility of ballistic strength training in sub-acute stroke: A randomized, controlled, assessor-blinded pilot study.

PubMed

Hendrey, Genevieve; Clark, Ross A; Holland, Anne E; Mentiplay, Benjamin F; Davis, Carly; Windfeld-Lund, Cristie; Raymond, Melissa J; Williams, Gavin

2018-05-30

To establish the feasibility and effectiveness of a six week ballistic strength training protocol in people with stroke. Randomized, controlled, assessor-blinded study. Sub-acute inpatient rehabilitation. Consecutively admitted inpatients with a primary diagnosis of first ever stroke with lower limb weakness, functional ambulation category score of ≥3, and ability to walk ≥14m were screened for eligibility to recruit 30 participants for randomization. Participants were randomized to standard therapy or ballistic strength training three times per week for six weeks. The primary aim was to evaluate feasibility and outcomes included recruitment rate, participant retention and attrition, feasibility of the exercise protocol, therapist burden and participant safety. Secondary outcomes included measures of mobility, lower limb muscle strength, muscle power and quality of life. Thirty participants (11% of those screened) with mean age of 50 (SD 18) years were randomized. The median number of sessions attended was 15/18 and 17/18 for the ballistic and control groups respectively. Earlier than expected discharge home (n=4) and illness (n=7) were the most common reasons for non-attendance. Participants performed the exercises safely, with no study-related adverse events. There were significant (p<0.05) between-group changes favoring the ballistic group for comfortable gait velocity (mean difference (MD) 0.31m/s, 95% confidence interval CI: 0.08 to 0.52), muscle power, as measured by peak jump height (MD 8cm, 95% CI: 3 to 13) and peak propulsive velocity (MD 64cm/s, 95% CI: 17 to 112). Ballistic training was safe and feasible in select ambulant people with stroke. Similar rates of retention and attrition suggest that ballistic training was acceptable to patients. Secondary outcomes provide promising results that warrant further investigation in a larger trial. Copyright © 2018. Published by Elsevier Inc.

Line-of-sight pointing accuracy/stability analysis and computer simulation for small spacecraft

NASA Astrophysics Data System (ADS)

Algrain, Marcelo C.; Powers, Richard M.

1996-06-01

This paper presents a case study where a comprehensive computer simulation is developed to determine the driving factors contributing to spacecraft pointing accuracy and stability. The simulation is implemented using XMATH/SystemBuild software from Integrated Systems, Inc. The paper is written in a tutorial manner and models for major system components are described. Among them are spacecraft bus, attitude controller, reaction wheel assembly, star-tracker unit, inertial reference unit, and gyro drift estimators (Kalman filter). THe predicted spacecraft performance is analyzed for a variety of input commands and system disturbances. The primary deterministic inputs are desired attitude angles and rate setpoints. The stochastic inputs include random torque disturbances acting on the spacecraft, random gyro bias noise, gyro random walk, and star-tracker noise. These inputs are varied over a wide range to determine their effects on pointing accuracy and stability. The results are presented in the form of trade-off curves designed to facilitate the proper selection of subsystems so that overall spacecraft pointing accuracy and stability requirements are met.

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

PubMed

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

2014-11-01

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

Application of random effects to the study of resource selection by animals

USGS Publications Warehouse

Gillies, C.S.; Hebblewhite, M.; Nielsen, S.E.; Krawchuk, M.A.; Aldridge, Cameron L.; Frair, J.L.; Saher, D.J.; Stevens, C.E.; Jerde, C.L.

2006-01-01

1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence.2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability.3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed.4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects.5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection.6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions limiting their generality. This approach will allow researchers to appropriately estimate marginal (population) and conditional (individual) responses, and account for complex grouping, unbalanced sample designs and autocorrelation.

Application of random effects to the study of resource selection by animals.

PubMed

Gillies, Cameron S; Hebblewhite, Mark; Nielsen, Scott E; Krawchuk, Meg A; Aldridge, Cameron L; Frair, Jacqueline L; Saher, D Joanne; Stevens, Cameron E; Jerde, Christopher L

2006-07-01

1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence. 2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability. 3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed. 4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects. 5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection. 6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions limiting their generality. This approach will allow researchers to appropriately estimate marginal (population) and conditional (individual) responses, and account for complex grouping, unbalanced sample designs and autocorrelation.

Surrogacy of progression-free survival (PFS) for overall survival (OS) in esophageal cancer trials with preoperative therapy: Literature-based meta-analysis.

PubMed

Kataoka, K; Nakamura, K; Mizusawa, J; Kato, K; Eba, J; Katayama, H; Shibata, T; Fukuda, H

2017-10-01

There have been no reports evaluating progression-free survival (PFS) as a surrogate endpoint in resectable esophageal cancer. This study was conducted to evaluate the trial level correlations between PFS and overall survival (OS) in resectable esophageal cancer with preoperative therapy and to explore the potential benefit of PFS as a surrogate endpoint for OS. A systematic literature search of randomized trials with preoperative chemotherapy or preoperative chemoradiotherapy for esophageal cancer reported from January 1990 to September 2014 was conducted using PubMed and the Cochrane Library. Weighted linear regression using sample size of each trial as a weight was used to estimate coefficient of determination (R 2 ) within PFS and OS. The primary analysis included trials in which the HR for both PFS and OS was reported. The sensitivity analysis included trials in which either HR or median survival time of PFS and OS was reported. In the sensitivity analysis, HR was estimated from the median survival time of PFS and OS, assuming exponential distribution. Of 614 articles, 10 trials were selected for the primary analysis and 15 for the sensitivity analysis. The primary analysis did not show a correlation between treatment effects on PFS and OS (R 2 0.283, 95% CI [0.00-0.90]). The sensitivity analysis did not show an association between PFS and OS (R 2 0.084, 95% CI [0.00-0.70]). Although the number of randomized controlled trials evaluating preoperative therapy for esophageal cancer is limited at the moment, PFS is not suitable for primary endpoint as a surrogate endpoint for OS. Copyright © 2017 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

The preliminary development and testing of a global trigger tool to detect error and patient harm in primary-care records.

PubMed

de Wet, C; Bowie, P

2009-04-01

A multi-method strategy has been proposed to understand and improve the safety of primary care. The trigger tool is a relatively new method that has shown promise in American and secondary healthcare settings. It involves the focused review of a random sample of patient records using a series of "triggers" that alert reviewers to potential errors and previously undetected adverse events. To develop and test a global trigger tool to detect errors and adverse events in primary-care records. Trigger tool development was informed by previous research and content validated by expert opinion. The tool was applied by trained reviewers who worked in pairs to conduct focused audits of 100 randomly selected electronic patient records in each of five urban general practices in central Scotland. Review of 500 records revealed 2251 consultations and 730 triggers. An adverse event was found in 47 records (9.4%), indicating that harm occurred at a rate of one event per 48 consultations. Of these, 27 were judged to be preventable (42%). A further 17 records (3.4%) contained evidence of a potential adverse event. Harm severity was low to moderate for most patients (82.9%). Error and harm rates were higher in those aged > or =60 years, and most were medication-related (59%). The trigger tool was successful in identifying undetected patient harm in primary-care records and may be the most reliable method for achieving this. However, the feasibility of its routine application is open to question. The tool may have greater utility as a research rather than an audit technique. Further testing in larger, representative study samples is required.

Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications. Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation. This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. Methods/design The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo. Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years, determined at 12 weeks. The analysis will be based on all participants as randomized (intention to treat). The trial has 90% power with a type I error rate of 5% to detect a 10% increase in primary outcome between the tamsulosin and nifedipine treatment groups. Trial registration ISRCTN69423238; EudraCT number: 2010-019469-26 PMID:24947817

Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial.

PubMed

McClinton, Sam; Starr, Kathryn; Thomas, Ruth; McLennan, Graeme; McPherson, Gladys; McDonald, Alison; Lam, Thomas; N'Dow, James; Kilonzo, Mary; Pickard, Robert; Anson, Ken; Burr, Jennifer

2014-06-20

Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications.Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation.This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo.Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years, determined at 12 weeks. The analysis will be based on all participants as randomized (intention to treat). The trial has 90% power with a type I error rate of 5% to detect a 10% increase in primary outcome between the tamsulosin and nifedipine treatment groups. ISRCTN69423238; EudraCT number: 2010-019469-26.

Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: A randomized controlled open-label trial

PubMed Central

Adenis, A.; Blay, J.-Y.; Bui-Nguyen, B.; Bouché, O.; Bertucci, F.; Isambert, N.; Bompas, E.; Chaigneau, L.; Domont, J.; Ray-Coquard, I.; Blésius, A.; Van Tine, B. A.; Bulusu, V. R.; Dubreuil, P.; Mansfield, C. D.; Acin, Y.; Moussy, A.; Hermine, O.; Le Cesne, A.

2014-01-01

Background Masitinib is a highly selective tyrosine kinase inhibitor with activity against the main oncogenic drivers of gastrointestinal stromal tumor (GIST). Masitinib was evaluated in patients with advanced GIST after imatinib failure or intolerance. Patients and methods Prospective, multicenter, randomized, open-label trial. Patients with inoperable, advanced imatinib-resistant GIST were randomized (1 : 1) to receive masitinib (12 mg/kg/day) or sunitinib (50 mg/day 4-weeks-on/2-weeks-off) until progression, intolerance, or refusal. Primary efficacy analysis was noncomparative, testing whether masitinib attained a median progression-free survival (PFS) (blind centrally reviewed RECIST) threshold of >3 months according to the lower bound of the 90% unilateral confidence interval (CI). Secondary analyses on overall survival (OS) and PFS were comparative with results presented according to a two-sided 95% CI. Results Forty-four patients were randomized to receive masitinib (n = 23) or sunitinib (n = 21). Median follow-up was 14 months. Patients receiving masitinib experienced less toxicity than those receiving sunitinib, with significantly lower occurrence of severe adverse events (52% versus 91%, respectively, P = 0.008). Median PFS (central RECIST) for the noncomparative primary analysis in the masitinib treatment arm was 3.71 months (90% CI 3.65). Secondary analyses showed that median OS was significantly longer for patients receiving masitinib followed by post-progression addition of sunitinib when compared against patients treated directly with sunitinib in second-line [hazard ratio (HR) = 0.27, 95% CI 0.09–0.85, P = 0.016]. This improvement was sustainable as evidenced by 26-month follow-up OS data (HR = 0.40, 95% CI 0.16–0.96, P = 0.033); an additional 12.4 months survival advantage being reported for the masitinib treatment arm. Risk of progression while under treatment with masitinib was in the same range as for sunitinib (HR = 1.1, 95% CI 0.6–2.2, P = 0.833). Conclusions Primary efficacy analysis ensured the masitinib treatment arm could satisfy a prespecified PFS threshold. Secondary efficacy analysis showed that masitinib followed by the standard of care generated a statistically significant survival benefit over standard of care. Encouraging median OS and safety data from this well-controlled and appropriately designed randomized trial indicate a positive benefit–risk ratio. Further development of masitinib in imatinib-resistant/intolerant patients with advanced GIST is warranted. PMID:25122671

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Lurie, Jon D.; Tosteson, Tor D.; Tosteson, Anna N. A.; Zhao, Wenyan; Morgan, Tamara S.; Abdu, William A.; Herkowitz, Harry; Weinstein, James N.

2014-01-01

Study Design Concurrent prospective randomized and observational cohort studies. Objective To assess the 8-year outcomes of surgery vs. non-operative care. Summary of Background Data Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial. Methods Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter. Results Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (−36.2 vs. −24.8; −11.2; −13.6 to −9.1). Conclusion Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years. PMID:24153171

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

PubMed

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

2014-03-26

Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. ClinicalTrials.gov NCT01821222; http://www.clinicaltrials.gov/ct2/show/NCT01821222 (Archived by WebCite at http://www.webcitation.org/6NqxnxYn0).

Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study)

PubMed Central

2013-01-01

Background Colorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening. Methods/Design A total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC. Discussion This study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC. Trial registration ClinicalTrials.gov Identifier: NCT01651624. PMID:23497601

Kansas Primary Care Weighs In: A Pilot Randomized Trial of a Chronic Care Model Program for Obesity in 3 Rural Kansas Primary Care Practices

ERIC Educational Resources Information Center

Ely, Andrea C.; Banitt, Angela; Befort, Christie; Hou, Qing; Rhode, Paula C.; Grund, Chrysanne; Greiner, Allen; Jeffries, Shawn; Ellerbeck, Edward

2008-01-01

Context: Obesity is a chronic disease of epidemic proportions in the United States. Primary care providers are critical to timely diagnosis and treatment of obesity, and need better tools to deliver effective obesity care. Purpose: To conduct a pilot randomized trial of a chronic care model (CCM) program for obesity care in rural Kansas primary…

Child language interventions in public health: a systematic literature review.

PubMed

De Cesaro, Bruna Campos; Gurgel, Léia Gonçalves; Nunes, Gabriela Pisoni Canedo; Reppold, Caroline Tozzi

2013-01-01

Systematically review the literature on interventions in children's language in primary health care. One searched the electronic databases (January 1980 to March 2013) MEDLINE (accessed by PubMed), Scopus, Lilacs and Scielo. The search terms used were "child language", "primary health care", "randomized controlled trial" and "intervention studies" (in English, Portuguese and Spanish). There were included any randomized controlled trials that addressed the issues child language and primary health care. The analysis was based on the type of language intervention conducted in primary health care. Seven studies were included and used intervention strategies such as interactive video, guidance for parents and group therapy. Individuals of both genders were included in the seven studies. The age of the children participant in the samples of the articles included in this review ranged from zero to 11 years. These seven studies used approaches that included only parents, parents and children or just children. The mainly intervention in language on primary health care, used in randomized controlled trials, involved the use of interactional video. Several professionals, beyond speech and language therapist, been inserted in the language interventions on primary health care, demonstrating the importance of interdisciplinary work. None of the articles mentioned aspects related to hearing. There was scarcity of randomized controlled trials that address on language and public health, either in Brazil or internationally.

Analysis of the project synthesis goal cluster orientation and inquiry emphasis of elementary science textbooks

NASA Astrophysics Data System (ADS)

Staver, John R.; Bay, Mary

The purpose of this descriptive study was to examine selected units of commonly used elementary science texts, using the Project Synthesis goal clusters as a framework for part of the examination. An inquiry classification scheme was used for the remaining segment. Four questions were answered: (1) To what extent do elementary science textbooks focus on each Project Synthesis goal cluster? (2) In which part of the text is such information found? (3) To what extent are the activities and experiments merely verifications of information already introduced in the text? (4) If inquiry is present in an activity, then what is the level of such inquiry?Eleven science textbook series, which comprise approximately 90 percent of the national market, were selected for analysis. Two units, one primary (K-3) and one intermediate (4-6), were selected for analysis by first identifying units common to most series, then randomly selecting one primary and one intermediate unit for analysis.Each randomly selected unit was carefully read, using the sentence as the unit of analysis. Each declarative and interrogative sentence in the body of the text was classified as: (1) academic; (2) personal; (3) career; or (4) societal in its focus. Each illustration, except those used in evaluation items, was similarly classified. Each activity/experiment and each miscellaneous sentence in end-of-chapter segments labelled review, summary, evaluation, etc., were similarly classified. Finally, each activity/experiment, as a whole, was categorized according to a four-category inquiry scheme (confirmation, structured inquiry, guided inquiry, open inquiry).In general, results of the analysis are: (1) most text prose focuses on academic science; (2) most remaining text prose focuses on the personal goal cluster; (3) the career and societal goal clusters receive only minor attention; (4) text illustrations exhibit a pattern similar to text prose; (5) text activities/experiments are academic in orientation, almost to the exclusion of other goal clusters; (6) end-of-chapter sentences are largely academic; (7) inquiry is absent or present only in limited forms in text activities/experiments; and (8) texts allocate only a minor portion of space to activities/experiments. Detailed findings are given as numeral, percentage, and decimal values. Discussion focuses on the implications of the results and a comparison of NSTA recommendations with the results of this analysis.

The evidence for immunotherapy in dermatomyositis and polymyositis: a systematic review.

PubMed

Vermaak, Erin; Tansley, Sarah L; McHugh, Neil J

2015-12-01

Dermatomyositis and polymyositis are rare chronic inflammatory disorders with significant associated morbidity and mortality despite treatment. High-dose corticosteroids in addition to other interventions such as immunosuppressants, immunomodulators, and more recently, biologics are commonly used in clinical practice; however, there are no clear guidelines directing their use. Our objective was to systematically review the evidence for immunotherapy in the treatment of dermatomyositis and polymyositis. Relevant studies were identified through Embase and PubMed database searches. Trials were selected using pre-determined selection criteria and then assessed for quality. Randomized controlled trials and experimental studies without true randomization and including adult patients with definite or probable dermatomyositis or polymyositis were evaluated. Any type of immunotherapy was considered. Clinical improvement, judged by assessment of muscle strength after 6 months, was the primary outcome. Secondary outcomes included IMACS definition of improvement, improvements in patient and physician global scores, physical function, and muscle enzymes. Twelve studies met eligibility criteria. Differences in trial design, quality, and variable reporting of baseline characteristics and outcomes made direct comparison impossible. Although no treatment can be recommended on the basis of this review, improved outcomes were demonstrated with a number of agents including methotrexate, azathioprine, ciclosporin, rituximab, and intravenous immunoglobulin. Plasmapheresis and leukapheresis were of no apparent benefit. More high-quality randomized controlled trials are needed to establish the role of immunosuppressive agents in the treatment of these conditions and the clinical context in which they are most likely to be beneficial.

Modelling changes in small area disability free life expectancy: trends in London wards between 2001 and 2011.

PubMed

Congdon, Peter

2014-12-20

Existing analyses of trends in disability free life expectancy (DFLE) are mainly at aggregate level (national or broad regional). However, major differences in DFLE, and trends in these expectancies, exist between different neighbourhoods within regions, so supporting a small area perspective. However, this raises issues regarding the stability of conventional life table estimation methods at small area scales. This paper advocates a Bayesian borrowing strength technique to model trends in mortality and disability differences across 625 small areas in London, using illness data from the 2001 and 2011 population Censuses, and deaths data for two periods centred on the Census years. From this analysis, estimates of total life expectancy and DFLE are obtained. The spatio-temporal modelling perspective allows assessment of whether significant compression or expansion of morbidity has occurred in each small area. Appropriate models involve random effects that recognise correlation and interaction effects over relevant dimensions of the observed deaths and illness data (areas, ages), as well as major spatial trends (e.g. gradients in health and mortality according to area deprivation category). Whilst borrowing strength is a primary consideration (and demonstrated by raised precision for estimated life expectancies), so also is model parsimony. Therefore, pure borrowing strength models are compared with models allowing selection of random age-area interaction effects using a spike-slab prior, and in fact borrowing strength combined with random effects selection provides better fit. Copyright © 2014 John Wiley & Sons, Ltd.

Results from 2 proof-of-concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder.

PubMed

Spencer, Thomas; Heiligenstein, John H; Biederman, Joseph; Faries, Douglas E; Kratochvil, Christopher J; Conners, C Keith; Potter, William Z

2002-12-01

Atomoxetine is a nonstimulant drug being studied for the treatment of attention-deficit/hyperactivity disorder (ADHD). Atomoxetine is a highly specific inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or other neurotransmitter transporters or receptors. Results of 2 proof-of-concept studies are reported that tested the hypothesis that a selective inhibitor of presynaptic norepinephrine uptake would be effective for the treatment of ADHD in school-aged children. Two identical 12-week, stratified, randomized, double-blind, placebo-controlled trials were conducted in children who met DSM-IV criteria for ADHD. The primary efficacy outcome measure was the mean change from baseline to endpoint in the Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD RS) total score. Secondary efficacy measures included the Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) and the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S). A total of 291 patients were randomized in the 2 trials combined (Study 1, N = 147; Study 2, N = 144). Stimulant-naive patients were randomized to atomoxetine, placebo, or methylphenidate. Patients with prior stimulant exposure were randomized to atomoxetine or placebo. Atomoxetine significantly reduced ADHD RS total scores compared with placebo in each study (p <.001). Changes in the CGI-ADHD-S (Study 1: p =.003; Study 2: p =.001) and CPRS-ADHD Index (Study 1: p =.023; Study 2: p <.001) also showed atomoxetine to be statistically significantly superior to placebo in reducing ADHD symptoms. Atomoxetine was found to be well tolerated in this population of pediatric patients. Two studies of atomoxetine early in its development confirmed that atomoxetine, a specific and selective inhibitor of noradrenergic uptake, was effective for the treatment of children with ADHD. In addition, atomoxetine was found to be well tolerated.

Optimizing the Primary Prevention of Type-2 Diabetes in Primary Health Care

ClinicalTrials.gov

2017-08-18

Interprofessional Relations; Primary Health Care/Organization & Administration; Diabetes Mellitus, Type 2/Prevention & Control; Primary Prevention/Methods; Risk Reduction Behavior; Randomized Controlled Trial; Life Style

Comparative Evaluation of Shear Bond Strength of Three Commercially Available Glass Ionomer Cements in Primary Teeth

PubMed Central

Murthy, S Srinivasa; Murthy, Gargi S

2015-01-01

Background: This study aims to comparatively evaluate the shear bond strength (SBS) of three commercially available glass ionomer cements - Miracle Mix (MM) (GC America Inc., Alsip, USA), Ketac Molar (KM) (3M Corp., Minnesota, USA) and amalgomer CR (AM) (Advanced Healthcare Ltd., Kent, England) in primary teeth and later examine the mode of the adhesive failure at the interface. Materials and Methods: Totally, 90 extracted sound primary molars were selected, and dentin on the buccal surface of crowns was exposed. Specimens were randomly assigned into three groups according to the restorative materials being tested. SBS tests were performed, and the obtained values were statistically analyzed using ANOVA and Tukey tests (P < 0.05). SBS mean values on were recorded in megapascals (MPa) and the mode of failure was assessed using a scanning electron microscope. Results: SBS (in MPa) was - MM-5.39, KM-4.84, AM-6.38. The predominant failure mode was cohesive. Conclusion: Amalgomer CR exhibited statistically significant higher SBS of 6.38 MPa to primary teeth and has better adhesion to the primary teeth compared to the other test materials and can be considered as a restorative material in pediatric dentistry. However, the results of this study should be corroborated with further investigation to reach a definitive conclusion. PMID:26464550

Does the Implant Surgical Technique Affect the Primary and/or Secondary Stability of Dental Implants? A Systematic Review

PubMed Central

Shadid, Rola Muhammed; Sadaqah, Nasrin Rushdi; Othman, Sahar Abdo

2014-01-01

Background. A number of surgical techniques for implant site preparation have been advocated to enhance the implant of primary and secondary stability. However, there is insufficient scientific evidence to support the association between the surgical technique and implant stability. Purpose. This review aimed to investigate the influence of different surgical techniques including the undersized drilling, the osteotome, the piezosurgery, the flapless procedure, and the bone stimulation by low-level laser therapy on the primary and/or secondary stability of dental implants. Materials and methods. A search of PubMed, Cochrane Library, and grey literature was performed. The inclusion criteria comprised observational clinical studies and randomized controlled trials (RCTs) conducted in patients who received dental implants for rehabilitation, studies that evaluated the association between the surgical technique and the implant primary and/or secondary stability. The articles selected were carefully read and classified as low, moderate, and high methodological quality and data of interest were tabulated. Results. Eight clinical studies were included then they were classified as moderate or high methodological quality and control of bias. Conclusions. There is a weak evidence suggesting that any of previously mentioned surgical techniques could influence the primary and/or secondary implant stability. PMID:25126094

Clinical and radiographic evaluation of zinc oxide with aloe vera as an obturating material in pulpectomy: an in vivo study.

PubMed

Khairwa, Abhishek; Bhat, Manohar; Sharma, Rajesh; Satish, V; Maganur, Prabhadevi; Goyal, Anil Kumar

2014-01-01

Pulp therapy for pulpally involved primary teeth continues to be a challenge to clinicians. One of the major areas of continued research is in the area of finding obturating materials to suit the specific properties of these teeth. Zinc oxide eugenol is used frequently in pulpectomy for the obturation of the primary teeth. To evaluate clinically and radiographically a mixture of zinc oxide eugenol and aloe vera as an obturating material. A total of 50 children, aged between 4 and 9 years, who were screened for unilateral or bilateral carious deciduous molars were studied. Out of these, 15 children were randomly selected for endodontic treatment. Obturation was done with a mixture of zinc oxide powder and aloe vera gel. Clinical and radiographic evaluation was done after 7 days, 1 month, 3 months, 6 months, and 9 months. The data were statistically analyzed. Endodontic treatment using a mixture of zinc oxide powder and aloe vera gel in primary teeth has shown good clinical and radiographic success. A detailed observational study with longer follow-up will highlight the benefits of aloe vera in primary teeth as an obturating medium.

Managing an Online Survey about Influenza Vaccination in Primary Healthcare Workers

PubMed Central

Toledo, Diana; Aerny, Nicole; Soldevila, Núria; Baricot, Maretva; Godoy, Pere; Castilla, Jesús; García-Gutierrez, Susana; Torner, Núria; Astray, Jenaro; Mayoral, José María; Tamames, Sonia; González-Candelas, Fernando; Martín, Vicente; Díaz, José; Domíguez, Angela

2015-01-01

Online surveys are increasingly used due to their speed and efficiency. The aim of this study was to analyze factors that may have contributed to the quality and speed of response of an online survey on influenza vaccination in primary healthcare workers. A multicenter study including family physicians, nurses and pediatricians from primary healthcare teams from seven Spanish Autonomous Communities was designed. The centers were selected by simple random sampling. The survey remained active and accessible for 56 days and four reminders were sent. The odds ratios (OR) and their 95% confidence intervals (CI) were calculated to assess the association of sociodemographic variables and responding to the survey before the second reminder. Complete, validated information was obtained from 1965 primary healthcare workers. The total response rate was 36.2%. More nurses (46.3%) responded before the second reminder and more family physicians (52.8%) after the second reminder. The adjusted OR shows that family physicians responded later (AOR 1.46, 95% CI 1.2–1.8) than nurses. The responses obtained in the first 24 h after the initial sending and the reminders accounted for 41.7% of the completed surveys, indicating the importance of reminders. PMID:25584421

Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

PubMed

Ramallo-Fariña, Yolanda; García-Pérez, Lidia; Castilla-Rodríguez, Iván; Perestelo-Pérez, Lilisbeth; Wägner, Ana María; de Pablos-Velasco, Pedro; Domínguez, Armando Carrillo; Cortés, Mauro Boronat; Vallejo-Torres, Laura; Ramírez, Marcos Estupiñán; Martín, Pablo Pedrianes; García-Puente, Ignacio; Salinero-Fort, Miguel Ángel; Serrano-Aguilar, Pedro Guillermo

2015-04-09

Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands. The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients. Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used to analyze changes in outcomes. The cost-effectiveness analysis, from the healthcare services perspective, involves direct medical costs per quality-adjusted life year gained and two periods, a 'within-trial' period and a lifetime Markov model. Deterministic and probabilistic sensitivity analyses are planned. This ongoing trial aims to set up the implementation of evidence-based programs in the clinical setting for chronic patients. Clinical Trial.gov NCT01657227.

Cost-effectiveness of strategies to market and train primary health care physicians in brief intervention techniques for hazardous alcohol use.

PubMed

Gomel, M K; Wutzke, S E; Hardcastle, D M; Lapsley, H; Reznik, R B

1998-07-01

The cost-effectiveness of strategies to market and train primary care physicians in brief intervention for hazardous alcohol consumption was examined. Physicians were randomly assigned to one of three marketing strategies designed to promote the "uptake" of a brief intervention package for hazardous and harmful alcohol consumption. The strategies were direct mail, tele-marketing, or academic detailing. One hundred and twenty-seven of those physicians who requested the package during the marketing phase (phase 1) and who also agreed to participate in the training and support phase of the project (phase 2) were matched into one of three training and support conditions: training and no support, training and minimal support, training and maximal support. An additional 34 physicians were randomly selected and assigned to a control condition. The ultimate aim of training and support was to maximise physician screening and counselling rates. Tele-marketing was found to be more cost-effective than academic detailing and direct mail in promoting the uptake of the package. For the training and support phase costs and effects increased with the level of support, hence the issue to be considered is whether the additional cost incurred in moving from one strategy to another is warranted given the increase in the level of outcome.

Patient or treatment centre? Where are efforts invested to improve cancer patients' psychosocial outcomes?

PubMed Central

Carey, ML; Clinton-McHarg, T; Sanson-Fisher, RW; Campbell, S; Douglas, HE

2011-01-01

The psychosocial outcomes of cancer patients may be influenced by individual-level, social and treatment centre predictors. This paper aimed to examine the extent to which individual, social and treatment centre variables have been examined as predictors or targets of intervention for psychosocial outcomes of cancer patients. Medline was searched to find studies in which the psychological outcomes of cancer patient were primary variables. Papers published in English between 1999 and 2009 that reported primary data relevant to psychosocial outcomes for cancer patients were included, with 20% randomly selected for further coding. Descriptive studies were coded for inclusion of individual, social or treatment centre variables. Intervention studies were coded to determine if the unit of intervention was the individual patient, social unit or treatment centre. After random sampling, 412 publications meeting the inclusion criteria were identified, 169 were descriptive and 243 interventions. Of the descriptive papers 95.0% included individual predictors, and 5.0% social predictors. None of the descriptive papers examined treatment centre variables as predictors of psychosocial outcomes. Similarly, none of the interventions evaluated the effectiveness of treatment centre interventions for improving psychosocial outcomes. Potential reasons for the overwhelming dominance of individual predictors and individual-focused interventions in psychosocial literature are discussed. PMID:20646035

Press releases by academic medical centers: not so academic?

PubMed

Woloshin, Steven; Schwartz, Lisa M; Casella, Samuel L; Kennedy, Abigail T; Larson, Robin J

2009-05-05

The news media are often criticized for exaggerated coverage of weak science. Press releases, a source of information for many journalists, might be a source of those exaggerations. To characterize research press releases from academic medical centers. Content analysis. Press releases from 10 medical centers at each extreme of U.S. News & World Report's rankings for medical research. Press release quality. Academic medical centers issued a mean of 49 press releases annually. Among 200 randomly selected releases analyzed in detail, 87 (44%) promoted animal or laboratory research, of which 64 (74%) explicitly claimed relevance to human health. Among 95 releases about primary human research, 22 (23%) omitted study size and 32 (34%) failed to quantify results. Among all 113 releases about human research, few (17%) promoted studies with the strongest designs (randomized trials or meta-analyses). Forty percent reported on the most limited human studies--those with uncontrolled interventions, small samples (<30 participants), surrogate primary outcomes, or unpublished data--yet 58% lacked the relevant cautions. The effects of press release quality on media coverage were not directly assessed. Press releases from academic medical centers often promote research that has uncertain relevance to human health and do not provide key facts or acknowledge important limitations. National Cancer Institute.

The Prevalence of Visual Acuity Impairment among School Children at Arada Subcity Primary Schools in Addis Ababa, Ethiopia.

PubMed

Darge, Haile Fentahun; Shibru, Getahun; Mulugeta, Abiy; Dagnachew, Yinebeb Mezgebu

2017-01-01

Visual impairment and blindness are major public health problems in developing countries where there is no enough health-care service. To determine the prevalence of visual impairment among school children. A school-based cross-sectional study was conducted between 15 June 2015 and 30 November 2015 at Arada subcity primary schools, Addis Ababa, Ethiopia. Two schools were selected randomly, and 378 students were screened from grades 1 to 8 using systematic random sampling method. Snellen chart was used for visual acuity test. Students who had visual acuity of ≤6/12 were further examined by an ophthalmologist to diagnose the reason for low vision. Data was analyzed using SPSS version 20. A total of 378 students were screened, and 192 (50.8%) were females and the remaining 186 (49.2%) were males. The prevalence of visual impairment (VA) of ≤6/12 on either eye was 5.8%, VA < 6/18 on either eye was 1.1%, and VA < 6/18 on the better eye was 0.53%. In this study, color blindness [OR: 19.65, 95% CI (6.01-64.33)] was significantly associated with visual acuity impairment. The prevalence of visual impairment among school children in the study area was 5.8% and school screening is recommended.

The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema.

PubMed

Wood, Douglas E; Nader, Daniel A; Springmeyer, Steven C; Elstad, Mark R; Coxson, Harvey O; Chan, Andrew; Rai, Navdeep S; Mularski, Richard A; Cooper, Christopher B; Wise, Robert A; Jones, Paul W; Mehta, Atul C; Gonzalez, Xavier; Sterman, Daniel H

2014-10-01

Lung volume reduction surgery improves quality of life, exercise capacity, and survival in selected patients but is accompanied by significant morbidity. Bronchoscopic approaches may provide similar benefits with less morbidity. In a randomized, sham procedure controlled, double-blind trial, 277 subjects were enrolled at 36 centers. Patients had emphysema, airflow obstruction, hyperinflation, and severe dyspnea. The primary effectiveness measure was a significant improvement in disease-related quality of life (St. George's Respiratory Questionnaire) and changes in lobar lung volumes. The primary safety measure was a comparison of serious adverse events. There were 6/121 (5.0%) responders in the treatment group at 6 months, significantly >1/134 (0.7%) in the control group [Bayesian credible intervals (BCI), 0.05%, 9.21%]. Lobar volume changes were significantly different with an average decrease in the treated lobes of -224 mL compared with -17 mL for the control group (BCI, -272, -143). The proportion of responders in St. George's Respiratory Questionnaire was not greater in the treatment group. There were significantly more subjects with a serious adverse event in the treatment group (n=20 or 14.1%) compared with the control group (n=5 or 3.7%) (BCI, 4.0, 17.1), but most were neither procedure nor device related. This trial had technical and statistical success but partial-bilateral endobronchial valve occlusion did not obtain clinically meaningful results. Safety results were acceptable and compare favorably to lung volume reduction surgery and other bronchial valve studies. Further studies need to focus on improved patient selection and a different treatment algorithm. ClinicalTrials.gov NCT00475007.

Evaluation of Cognitive and Behavioral Effects of Peer Education Model-Based Intervention to Sun Safe in Children

PubMed Central

HU, Ping; HAN, Lingli; SHARMA, Manoj; ZENG, Huan; ZHANG, Yong; LI, Hui; ZHAO, Yong

2014-01-01

Abstract Background There have been many studies that evidence the health hazards of sunlight exposure, but less study on sun safe intervention model, especially in China. Our aim was to evaluate the cognitive and behavioral effects of a peer education model-based intervention to sun safe in children. Methods Cluster random control intervention was conducted in one district in Chongqing, China. Two primary schools, selected through stratified clustered sampling approach (two grades in each school, three classes in each grade) were designated as intervention (n=304) and control schools (n=305) randomly. 36 students, selected as peer educators in intervention group, were trained for one month. Educational activities such as discussions were organized by peer educator for one month. There was no sun safe education to participants in control school during the project period. The evaluation of changes of sun safe knowledge (the primary outcome), attitude and behavior (the secondary outcome measures) were conducted before intervention and at months of 0, 1 and 6 of the intervention to two groups using quantitative and qualitative methods. Results After the intervention, sun safe knowledge score which gained by the students from intervention group has been remarkably improved, compared to baseline survey (24.48±6.17 vs. 29.51±6.75) (P<0.001), and it kept this high level (29.02±7.96 and. 28.65±8.96), while control group students' scores have made no difference (P=0.410). Most of students have changed their sun safe behavior after the intervention. Conclusion Peer education program is somewhat effective in some dimensions for improving children's understanding of sun safe knowledge and behavior. PMID:25988089

Effects of family presence on the content and dynamics of the clinical encounter among diabetic patients.

PubMed

Katerndahl, David; Parchman, Michael

2013-12-01

Primary care visits often include a family member or friend. The purpose of this study was to determine the effect of the presence of a family member on the visit content and dynamics among diabetic patients in Family Medicine settings. Encounters of patients with type 2 diabetes from 20 primary care clinics were audio-recorded and transcribed. Encounters were coded using the Davis Observation Codes, classifying content into 20 different categories at 15-second intervals. A random sample of 30 patients with family members was selected; 30 encounters in which no family was present were then matched to the randomly selected patients so that they would be similar group-wise in A1C level, length of visit, level of distress and discussion of non-patient family problems for analysis using orbital decomposition, an analytic technique based on symbolic dynamics in which categorical time series data are used to identify amount of complexity present and recurrent patterns of strings. Visits were more linear if family members were present. When family members were present, 90-second strings of preventive services and evaluation/feedback were observed while 90 seconds of exercise discussion occurred when they were absent. Visits without family members tended to include more chatting, compliance discussion and nutrition counselling, while those with family members included more patient questions and evaluation/feedback. Finally, the sequence of history-to-planning-to-evaluation was observed when family were absent, but evaluation-to-planning-to-history when family were present. The presence of a family member was associated with increased linearity and recurrent patterns that focused more on evaluation/feedback, preventive services, and patient questions, and less on chatting, exercise, compliance and nutrition in diabetic encounters. © 2013 John Wiley & Sons Ltd.

The relationship between hypochondriasis and medical illness.

PubMed

Barsky, A J; Wyshak, G; Latham, K S; Klerman, G L

1991-01-01

Forty-one Diagnostic and Statistical Manual of Mental Disorders-III-Revised hypochondriacs were accrued from a primary care practice. Seventy-five control subjects were selected at random from among the remainder of the patients in the same clinic. All subjects completed a structured diagnostic interview and standardized self-report questionnaires. Medical morbidity was assessed with a medical record audit and with primary physicians' ratings. The hypochondriacal and comparison samples did not differ in aggregate medical morbidity, although the hypochondriacal sample had more undiagnosed complaints and nonspecific findings in their medical records. Within the comparison sample, higher levels of medical morbidity were associated with higher levels of hypochondriacal symptoms. This occurred primarily because the most serious medical disorders were associated with more bodily preoccupation, disease conviction, and somatization. Within the hypochondriacal sample, no correlation was found between the degree of hypochondriasis and the extent of medical morbidity.

WHO/INRUD patient care and facility-specific drug use indicators at primary health care centres in Eastern province, Saudi Arabia.

PubMed

El Mahalli, A A; Akl, O A M; Al-Dawood, S F; Al-Nehab, A A; Al-Kubaish, H A; Al-Saeed, S; Elkahky, A A A; Salem, A M A A

2012-11-01

This study aimed to measure the performance of primary health care centres in Eastern province, Saudi Arabia, using the WHO/International Network of Rational Use of Drugs patient care and facility-specific drug use indicators. In a cross-sectional study, 10 health centres were selected using systematic random sampling. A total of 300 patients were interviewed while visiting the centre from January to March 2011 and 10 pharmacists from the same centres were interviewed. Average consultation time was 7.3 min (optimal > or = 30 min), percentage of drugs adequately labelled was 10% (optimal 100%) and patient's knowledge of correct dosage was 79.3% (optimal 100%). The percentage of key drugs in stock was only 59.2% (optimal 100%). An overall index of rational facility-specific drug use was calculated and applied to rank the health centres for benchmarking.

NullSeq: A Tool for Generating Random Coding Sequences with Desired Amino Acid and GC Contents.

PubMed

Liu, Sophia S; Hockenberry, Adam J; Lancichinetti, Andrea; Jewett, Michael C; Amaral, Luís A N

2016-11-01

The existence of over- and under-represented sequence motifs in genomes provides evidence of selective evolutionary pressures on biological mechanisms such as transcription, translation, ligand-substrate binding, and host immunity. In order to accurately identify motifs and other genome-scale patterns of interest, it is essential to be able to generate accurate null models that are appropriate for the sequences under study. While many tools have been developed to create random nucleotide sequences, protein coding sequences are subject to a unique set of constraints that complicates the process of generating appropriate null models. There are currently no tools available that allow users to create random coding sequences with specified amino acid composition and GC content for the purpose of hypothesis testing. Using the principle of maximum entropy, we developed a method that generates unbiased random sequences with pre-specified amino acid and GC content, which we have developed into a python package. Our method is the simplest way to obtain maximally unbiased random sequences that are subject to GC usage and primary amino acid sequence constraints. Furthermore, this approach can easily be expanded to create unbiased random sequences that incorporate more complicated constraints such as individual nucleotide usage or even di-nucleotide frequencies. The ability to generate correctly specified null models will allow researchers to accurately identify sequence motifs which will lead to a better understanding of biological processes as well as more effective engineering of biological systems.

An approximate generalized linear model with random effects for informative missing data.

PubMed

Follmann, D; Wu, M

1995-03-01

This paper develops a class of models to deal with missing data from longitudinal studies. We assume that separate models for the primary response and missingness (e.g., number of missed visits) are linked by a common random parameter. Such models have been developed in the econometrics (Heckman, 1979, Econometrica 47, 153-161) and biostatistics (Wu and Carroll, 1988, Biometrics 44, 175-188) literature for a Gaussian primary response. We allow the primary response, conditional on the random parameter, to follow a generalized linear model and approximate the generalized linear model by conditioning on the data that describes missingness. The resultant approximation is a mixed generalized linear model with possibly heterogeneous random effects. An example is given to illustrate the approximate approach, and simulations are performed to critique the adequacy of the approximation for repeated binary data.

Impact of different approaches of primary care mental health on the prevalence of mental disorders.

PubMed

Moscovici, Leonardo; de Azevedo-Marques, Joao Mazzoncini; Bolsoni, Lívia Maria; Rodrigues-Junior, Antonio Luiz; Zuardi, Antonio Waldo

2018-05-01

AimTo compare the impact of three different approaches to primary care mental health on the prevalence of mental disorders. Millions of people suffer from mental disorders. As entry point into the health service, primary healthcare plays an important role in providing mental health prevention and treatment. Random sample of households in three different areas of the city of Ribeirão Preto (state of São Paulo, Brazil) were selected, and 20 trained medical students conducted interviews using a mental health screening instrument, the Mini-Screening of Mental Disorders, and a socio-demographic datasheet. Primary care mental health was provided in each area through a specific approach. The influence of the area of residence and the socio-demographic variables on the prevalence of mental disorder was explored and analyzed by univariate binary logistic regression and then by a multiple logistic regression model.FindingsA total of 1545 subjects were interviewed. Comparison between the three areas showed a significantly higher number of people with mental disorders in the area covered by the primary care team that did not have physicians with specific primary care mental health training, even when this association was adjusted for the influence of age, education, and socio-economic status.Our results suggest that residing in areas with family physicians with mental health training is associated with a lower prevalence of mental disorders.

Virtual standardized patients: an interactive method to examine variation in depression care among primary care physicians

PubMed Central

Hooper, Lisa M.; Weinfurt, Kevin P.; Cooper, Lisa A.; Mensh, Julie; Harless, William; Kuhajda, Melissa C.; Epstein, Steven A.

2009-01-01

Background Some primary care physicians provide less than optimal care for depression (Kessler et al., Journal of the American Medical Association 291, 2581–90, 2004). However, the literature is not unanimous on the best method to use in order to investigate this variation in care. To capture variations in physician behaviour and decision making in primary care settings, 32 interactive CD-ROM vignettes were constructed and tested. Aim and method The primary aim of this methods-focused paper was to review the extent to which our study method – an interactive CD-ROM patient vignette methodology – was effective in capturing variation in physician behaviour. Specifically, we examined the following questions: (a) Did the interactive CD-ROM technology work? (b) Did we create believable virtual patients? (c) Did the research protocol enable interviews (data collection) to be completed as planned? (d) To what extent was the targeted study sample size achieved? and (e) Did the study interview protocol generate valid and reliable quantitative data and rich, credible qualitative data? Findings Among a sample of 404 randomly selected primary care physicians, our voice-activated interactive methodology appeared to be effective. Specifically, our methodology – combining interactive virtual patient vignette technology, experimental design, and expansive open-ended interview protocol – generated valid explanations for variations in primary care physician practice patterns related to depression care. PMID:20463864

[Current status of malaria control knowledge awareness of primary and sec- ondary school students in Xuzhou City].

PubMed

Sun, Xing-sheng; Li, Li; Zhang, Kan-kan

2015-12-01

To understand the current status of malaria control knowledge awareness of primary and secondary school students and its influencing factors in Yunlong District, Xuzhou City, so as to provide the evidence for improving the malaria prevention work. A total of 800 students from 4 urban and rural primary and secondary schools were randomly selected and investigated with questionnaires. The total awareness rate of malaria control knowledge was 61.27%, and the awareness rates of symptoms of malaria and malaria prevention were only 38.99% and 57.59% respectively. The main approach of obtaining the malaria control knowledge was media (51.52%). The univariate analysis showed that sex, area and different education levels affected the awareness rates of malaria control knowledge (P < 0.05), and the Logistic analysis showed that the awareness rate of malaria control knowledge of country students was lower than that of urban students (P < 0.05), and the awareness rate of malaria control knowledge of the secondary school students was higher than that of the primary school students (P < 0.05). The awareness rate of malaria control knowledge of primary and secondary school students in Yunlong District is lower than that required by the national standard. Therefore, the health education of malaria control should be strengthened, especially in countryside school students and primary school students.

Modified Angle's Classification for Primary Dentition

PubMed Central

Chandranee, Kaushik Narendra; Chandranee, Narendra Jayantilal; Nagpal, Devendra; Lamba, Gagandeep; Choudhari, Purva; Hotwani, Kavita

2017-01-01

Aim: This study aims to propose a modification of Angle's classification for primary dentition and to assess its applicability in children from Central India, Nagpur. Methods: Modification in Angle's classification has been proposed for application in primary dentition. Small roman numbers i/ii/iii are used for primary dentition notation to represent Angle's Class I/II/III molar relationships as in permanent dentition, respectively. To assess applicability of modified Angle's classification a cross-sectional preschool 2000 children population from central India; 3–6 years of age residing in Nagpur metropolitan city of Maharashtra state were selected randomly as per the inclusion and exclusion criteria. Results: Majority 93.35% children were found to have bilateral Class i followed by 2.5% bilateral Class ii and 0.2% bilateral half cusp Class iii molar relationships as per the modified Angle's classification for primary dentition. About 3.75% children had various combinations of Class ii relationships and 0.2% children were having Class iii subdivision relationship. Conclusions: Modification of Angle's classification for application in primary dentition has been proposed. A cross-sectional investigation using new classification revealed various 6.25% Class ii and 0.4% Class iii molar relationships cases in preschool children population in a metropolitan city of Nagpur. Application of the modified Angle's classification to other population groups is warranted to validate its routine application in clinical pediatric dentistry. PMID:29326514

Breast Cancer Chemoprevention: A Network Meta-Analysis of Randomized Controlled Trials.

PubMed

Mocellin, Simone; Pilati, Pierluigi; Briarava, Marta; Nitti, Donato

2016-02-01

Several agents have been advocated for breast cancer primary prevention. However, few of them appear effective, the associated severe adverse effects limiting their uptake. We performed a comprehensive search for randomized controlled trials (RCTs) reporting on the ability of chemoprevention agents (CPAs) to reduce the incidence of primary breast carcinoma. Using network meta-analysis, we ranked CPAs based simultaneously on efficacy and acceptability (an inverse measure of toxicity). All statistical tests were two-sided. We found 48 eligible RCTs, enrolling 271 161 women randomly assigned to receive either placebo or one of 21 CPAs. Aromatase inhibitors (anastrozole and exemestane, considered a single CPA class because of the lack of between-study heterogeneity; relative risk [RR] = 0.468, 95% confidence interval [CI] = 0.346 to 0.634), arzoxifene (RR = 0.415, 95% CI = 0.253 to 0.682), lasofoxifene (RR = 0.208, 95% CI = 0.079 to 0.544), raloxifene (RR = 0.572, 95% CI = 0.372 to 0.881), tamoxifen (RR = 0.708, 95% CI = 0.595 to 0.842), and tibolone (RR = 0.317, 95% CI = 0.127 to 0.792) were statistically significantly associated with a therapeutic effect, which was restricted to estrogen receptor-positive tumors of postmenopausal women (except for tamoxifen, which is active also during premenopause). Network meta-analysis ranking showed that the new selective estrogen receptor modulators (SERMs) arzoxifene, lasofoxifene, and raloxifene have the best benefit-risk ratio. Aromatase inhibitors and tamoxifen ranked second and third, respectively. These results provide physicians and health care regulatory agencies with RCT-based evidence on efficacy and acceptability of currently available breast cancer CPAs; at the same time, we pinpoint how much work still remains to be done before pharmacological primary prevention becomes a routine option to reduce the burden of this disease. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial.

PubMed

Demaerschalk, Bart M; Brown, Robert D; Roubin, Gary S; Howard, Virginia J; Cesko, Eldina; Barrett, Kevin M; Longbottom, Mary E; Voeks, Jenifer H; Chaturvedi, Seemant; Brott, Thomas G; Lal, Brajesh K; Meschia, James F; Howard, George

2017-09-01

Multicenter clinical trials attempt to select sites that can move rapidly to randomization and enroll sufficient numbers of patients. However, there are few assessments of the success of site selection. In the CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials), we assess factors associated with the time between site selection and authorization to randomize, the time between authorization to randomize and the first randomization, and the average number of randomizations per site per month. Potential factors included characteristics of the site, specialty of the principal investigator, and site type. For 147 sites, the median time between site selection to authorization to randomize was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified. The median time between authorization to randomize and a randomization was 4.6 months (interquartile range, 2.6, 10.5). Sites with authorization to randomize in only the carotid endarterectomy study were slower to randomize, and other factors examined were not significantly associated with time-to-randomization. The recruitment rate was 0.26 (95% confidence interval, 0.23-0.28) patients per site per month. By univariate analysis, factors associated with faster recruitment were authorization to randomize in both trials, principal investigator specialties of interventional radiology and cardiology, pre-trial reported performance >50 carotid angioplasty and stenting procedures per year, status in the top half of recruitment in the CREST trial, and classification as a private health facility. Participation in StrokeNet was associated with slower recruitment as compared with the non-StrokeNet sites. Overall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217. © 2017 American Heart Association, Inc.

A randomized, controlled trial of oral propranolol in infantile hemangioma.

PubMed

Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques

2015-02-19

Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by Pierre Fabre Dermatologie; ClinicalTrials.gov number, NCT01056341.).

Randomized controlled trials in dentistry: common pitfalls and how to avoid them.

PubMed

Fleming, Padhraig S; Lynch, Christopher D; Pandis, Nikolaos

2014-08-01

Clinical trials are used to appraise the effectiveness of clinical interventions throughout medicine and dentistry. Randomized controlled trials (RCTs) are established as the optimal primary design and are published with increasing frequency within the biomedical sciences, including dentistry. This review outlines common pitfalls associated with the conduct of randomized controlled trials in dentistry. Common failings in RCT design leading to various types of bias including selection, performance, detection and attrition bias are discussed in this review. Moreover, methods of minimizing and eliminating bias are presented to ensure that maximal benefit is derived from RCTs within dentistry. Well-designed RCTs have both upstream and downstream uses acting as a template for development and populating systematic reviews to permit more precise estimates of treatment efficacy and effectiveness. However, there is increasing awareness of waste in clinical research, whereby resource-intensive studies fail to provide a commensurate level of scientific evidence. Waste may stem either from inappropriate design or from inadequate reporting of RCTs; the importance of robust conduct of RCTs within dentistry is clear. Optimal reporting of randomized controlled trials within dentistry is necessary to ensure that trials are reliable and valid. Common shortcomings leading to important forms or bias are discussed and approaches to minimizing these issues are outlined. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Randomized Controlled Trial of COMPASS Web-Based and Face-to-Face Teacher Coaching in Autism

PubMed Central

Ruble, Lisa A.; McGrew, John H.; Toland, Michael D.; Dalrymple, Nancy J.; Jung, Lee Ann

2013-01-01

Objective Most children with autism rely on schools as their primary source of intervention, yet research has suggested that teachers rarely use evidence-based practices. To address the need for improved educational outcomes, a previously tested consultation intervention called the Collaborative Model for Promoting Competence and Success (COMPASS; Ruble, Dalrymple, & McGrew, 2010; Ruble, Dalrymple, & McGrew, 2012) was evaluated in a 2nd randomized controlled trial, with the addition of a web-based group. Method Forty-nine teacher–child dyads were randomized into 1 of 3 groups: (1) a placebo control (PBO) group, (2) COMPASS followed by face-to-face (FF) coaching sessions, and (3) COMPASS followed by web-based (WEB) coaching sessions. Three individualized goals (social, communication, and independence skills) were selected for intervention for each child. The primary outcome of independent ratings of child goal attainment and several process measures (e.g., consultant and teacher fidelity) were evaluated. Results Using an intent-to-treat approach, findings replicated earlier results with a very large effect size (d = 1.41) for the FF group and a large effect size (d = 1.12) for the WEB group relative to the PBO group. There were no differences in overall change across goal domains between the FF and WEB groups, suggesting the efficacy of videoconferencing technology. Conclusions COMPASS is effective and results in improved educational outcomes for young children with autism. Videoconferencing technology, as a scalable tool, has promise for facilitating access to autism specialists and bridging the research-to-practice gap. PMID:23438314

Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control.

PubMed

Quinn, Charlene C; Gruber-Baldini, Ann L; Shardell, Michelle; Weed, Kelly; Clough, Suzanne S; Peeples, Malinda; Terrin, Michael; Bronich-Hall, Lauren; Barr, Erik; Lender, Dan

2009-07-01

National data find glycemic control is within target (A1c<7.0%) for 37% of patients with diabetes, and only 7% meet recommended glycemic, lipid, and blood pressure goals. To compare active interventions and usual care for glucose control in a randomized clinical trial (RCT) among persons with diabetes cared for by primary care physicians (PCPs) over the course of 1 year. Physician practices (n=36) in 4 geographic areas are randomly assigned to 1 of 4 study groups. The intervention is a diabetes communication system, using mobile phones and patient/physician portals to allow patient-specific treatment and communication. All physicians receive American Diabetes Association (ADA) Guidelines for diabetes care. Patients with poor diabetes control (A1c> or =7.5%) at baseline (n=260) are enrolled in study groups based on PCP randomization. All study patients receive blood glucose (BG) meters and a year's supply of testing materials. Patients in three treatment groups select one of two mobile phone models, receive one-year unlimited mobile phone data and service plan, register on the web-based individual patient portal and receive study treatment phone software based on study assignment. Control group patients receive usual care from their PCP. The primary outcome is mean change in A1c over a 12-month intervention period. Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes. Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians. This RCT is ongoing.

Outcomes and moderators of a preventive school-based mental health intervention for children affected by war in Sri Lanka: a cluster randomized trial

PubMed Central

TOL, WIETSE A.; KOMPROE, IVAN H.; JORDANS, MARK J.D.; VALLIPURAM, ANAVARATHAN; SIPSMA, HEATHER; SIVAYOKAN, SAMBASIVAMOORTHY; MACY, ROBERT D.; DE JONG, JOOP T.

2012-01-01

We aimed to examine outcomes, moderators and mediators of a preventive school-based mental health intervention implemented by paraprofessionals in a war-affected setting in northern Sri Lanka. A cluster randomized trial was employed. Subsequent to screening 1,370 children in randomly selected schools, 399 children were assigned to an intervention (n=199) or waitlist control condition (n=200). The intervention consisted of 15 manualized sessions over 5 weeks of cognitive behavioral techniques and creative expressive elements. Assessments took place before, 1 week after, and 3 months after the intervention. Primary outcomes included post-traumatic stress disorder (PTSD), depressive, and anxiety symptoms. No main effects on primary outcomes were identified. A main effect in favor of intervention for conduct problems was observed. This effect was stronger for younger children. Furthermore, we found intervention benefits for specific subgroups. Stronger effects were found for boys with regard to PTSD and anxiety symptoms, and for younger children on pro-social behavior. Moreover, we found stronger intervention effects on PTSD, anxiety, and function impairment for children experiencing lower levels of current war-related stressors. Girls in the intervention condition showed smaller reductions on PTSD symptoms than waitlisted girls. We conclude that preventive school-based psychosocial interventions in volatile areas characterized by ongoing war-related stressors may effectively improve indicators of psychological wellbeing and posttraumatic stress-related symptoms in some children. However, they may undermine natural recovery for others. Further research is necessary to examine how gender, age and current war-related experiences contribute to differential intervention effects. PMID:22654944

Industry Collaboration and Primary Guest Authorship of High-Impact Randomized Clinical Trials: A Cross-Sectional Study.

PubMed

Roper, Nitin; Korenstein, Deborah

2015-10-01

Journals have increased disclosure requirements in recent years, in part to deter guest authorship. The prevalence of guest authorship among primary authors (first and last) in the current era of increased disclosure requirements is unknown. Our aim was to examine the self-reported prevalence of guest authorship among primary authors from a sample of randomized clinical trials with and without industry funding and industry collaboration in the design, analysis or reporting of trials. Cross-sectional analysis of randomized, drug/device clinical trials with published details on the "Role of the Funding Source/Sponsor" published in high-impact biomedical journals between 1 December 2011 and 31 November 2012. Phase 1 or 2 trials, secondary trial analyses, and trials that were not listed on ClinicalTrials.gov were excluded. Primary guest authorship was defined, based on International Committee of Medical Journal Editors (ICMJE) criteria, when neither the first nor last author contributed to either of the following: 1) the design of the trial or the analysis/interpretation of data; or 2) drafting part or all of the manuscript. One hundred and sixty-eight randomized clinical trials that met inclusion criteria were included. We measured differences in the prevalence of guest authorship between trials with neither industry funding nor collaboration and 1) trials with industry funding without collaboration, and 2) trials with industry funding with collaboration. The overall prevalence of primary guest authorship was 6 % (10/168). Primary guest authorship was significantly more common in trials with industry funding with collaboration than in those with neither industry funding nor collaboration [13.2 % (10/76) vs. 0 % (0/39); p < 0.02]. Primary guest authorship did not differ between trials with industry funding without collaboration and trials with neither industry funding nor collaboration. Among a sample of randomized, drug/device clinical trials in high-impact biomedical journals, primary guest authorship was overall uncommon and occurred exclusively among trials with industry funding with collaboration.

Nurse prescribing in Poland

PubMed Central

Binkowska-Bury, Monika; Więch, Paweł; Bazaliński, Dariusz; Marć, Małgorzata; Bartosiewicz, Anna; Januszewicz, Paweł

2016-01-01

Abstract The aim of this study was to identify and examine the differences in opinions held by health care professionals and the general public concerning the right to administer and prescribe medication which has been awarded to nurses and midwives in Poland. The study was conducted from December 1, 2014 to July 1, 2015, in randomly selected primary health care clinics, among 2227 individuals, including 849 subjects representing medical personnel of primary health care and 1378 patients receiving primary care services. The study used 2 versions of a questionnaire. The relationships were examined with χ2 test for independence and Kruskal–Wallis test. Health professionals do not believe the new rights awarded to nurses and midwives will reduce the waiting time for medical consultations (P < 0.001). Nurses’ qualifications for the new tasks were most highly rated by patients, whereas the least favorable opinion was expressed by doctors (P < 0.001). To introduce nurse prescribing it is necessary to develop a suitable strategy enabling implementation of the government's initiative and facilitating the process of taking up the new task by nurses. PMID:27537573

Does sex-ratio selection influence nest-site choice in a reptile with temperature-dependent sex determination?

PubMed

Mitchell, Timothy S; Maciel, Jessica A; Janzen, Fredric J

2013-12-07

Evolutionary theory predicts that dioecious species should produce a balanced primary sex ratio maintained by frequency-dependent selection. Organisms with environmental sex determination, however, are vulnerable to maladaptive sex ratios, because environmental conditions vary spatio-temporally. For reptiles with temperature-dependent sex determination, nest-site choice is a behavioural maternal effect that could respond to sex-ratio selection, as mothers could adjust offspring sex ratios by choosing nest sites that will have particular thermal properties. This theoretical prediction has generated decades of empirical research, yet convincing evidence that sex-ratio selection is influencing nesting behaviours remains absent. Here, we provide the first experimental evidence from nature that sex-ratio selection, rather than only viability selection, is probably an important component of nest-site choice in a reptile with temperature-dependent sex determination. We compare painted turtle (Chrysemys picta) neonates from maternally selected nest sites with those from randomly selected nest sites, observing no substantive difference in hatching success or survival, but finding a profound difference in offspring sex ratio in the direction expected based on historical records. Additionally, we leverage long-term data to reconstruct our sex ratio results had the experiment been repeated in multiple years. As predicted by theory, our results suggest that sex-ratio selection has shaped nesting behaviour in ways likely to enhance maternal fitness.

Does sex-ratio selection influence nest-site choice in a reptile with temperature-dependent sex determination?

PubMed Central

Mitchell, Timothy S.; Maciel, Jessica A.; Janzen, Fredric J.

2013-01-01

Evolutionary theory predicts that dioecious species should produce a balanced primary sex ratio maintained by frequency-dependent selection. Organisms with environmental sex determination, however, are vulnerable to maladaptive sex ratios, because environmental conditions vary spatio-temporally. For reptiles with temperature-dependent sex determination, nest-site choice is a behavioural maternal effect that could respond to sex-ratio selection, as mothers could adjust offspring sex ratios by choosing nest sites that will have particular thermal properties. This theoretical prediction has generated decades of empirical research, yet convincing evidence that sex-ratio selection is influencing nesting behaviours remains absent. Here, we provide the first experimental evidence from nature that sex-ratio selection, rather than only viability selection, is probably an important component of nest-site choice in a reptile with temperature-dependent sex determination. We compare painted turtle (Chrysemys picta) neonates from maternally selected nest sites with those from randomly selected nest sites, observing no substantive difference in hatching success or survival, but finding a profound difference in offspring sex ratio in the direction expected based on historical records. Additionally, we leverage long-term data to reconstruct our sex ratio results had the experiment been repeated in multiple years. As predicted by theory, our results suggest that sex-ratio selection has shaped nesting behaviour in ways likely to enhance maternal fitness. PMID:24266033

Rotary Mtwo system versus manual K-file instruments: efficacy in preparing primary and permanent molar root canals.

PubMed

Azar, Mohammad-Reza; Mokhtare, Maziar

2011-01-01

To compare the cleaning ability and preparation time of rotary instruments (Mtwo) and conventional manual instruments (K-file) in preparing primary and permanent molar root canals. Access cavities were prepared in 70 primary and 70 permanent teeth and India ink was injected into 120 canals of selected molars. The teeth were randomly divided into two main subgroups (n=20) and three control groups (n=10). In each of these main subgroups, either the manual instrument (K-file) or the rotary system (Mtwo) was used to prepare root canals. After cleaning the canals and clearing the teeth, dye removal was evaluated with the help of a stereomicroscope. In addition, the time needed for root canal preparation was recorded by a chronometer. Statistical analyses were done using the Kruskal-Wallis, Mann-Whitney and t tests. With regard to the cleaning ability of root canals, there were no significant differences between the K-file and Mtwo rotary system in primary and permanent teeth in the apical, middle or coronal third of the canals. Moreover, there were no significant differences between primary and permanent teeth prepared with K-files and rotary instruments. In all the groups, shorter times were recorded with the rotary technique. The working time was shorter in primary than in permanent teeth. The Mtwo rotary system showed acceptable cleaning ability in both primary and permanent teeth, and achieved results similar to those of K-files in less time.

Socioeconomic factors affecting patients’ utilization of primary care services at a Tertiary Teaching Hospital in Riyadh, Saudi Arabia

PubMed Central

Alsubaie, Abdulaziz M.; Almohaimede, Khaled A.; Aljadoa, Abdulrahman F.; Jarallah, Osamah J.; Althnayan, Yasser I.; Alturki, Yousef A.

2016-01-01

Background: Primary care services utilization is dependent on socioeconomic factors. It is proven that variation in socioeconomic factors result in discrepancies in the use of such services. Admittedly, research is limited on the socioeconomic factors affecting the utilization of primary care services in Saudi Arabia. Objectives: The aim of this research was to study the effect of the main socioeconomic factors affecting patients' utilization of primary care services at a tertiary teaching hospital, Riyadh, Saudi Arabia. Materials and Methods: A cross-sectional study was conducted from January to February 2014 in a primary care clinic of a tertiary teaching hospital in Riyadh city; subjects selected using a random consecutive sampling technique. A self-administered questionnaire in Arabic was given to the participants to collect the data which comprised sociodemographic data, utilization measures, and health needs. The data were analyzed using SPSS version 21. Results: A total of 358 subjects participated in the study. The main factors that best determine the utilization of primary health care clinic in a tertiary teaching hospital were the possession of a health insurance (P = 0.046, odds ratio [OR] = 8.333), and bad self-health-perception (P < 0.014, OR: 2.088). Chronic illness was also associated with higher utilization (OR = 2.003). Conclusion: Our results reveal that chronic health problems, self-health-perception, and health insurance are the most significant socioeconomic factors affecting the utilization of primary care services. PMID:26929723

Clinical Assessment of Various Obturating Techniques for Primary Teeth: A Comparative Study

PubMed Central

Tandon, Sandeep; Vijay, Akshat; Kalia, Garima; Rathore, Khushboo

2017-01-01

Introduction Lifelong preservation of tooth in a healthy state is the ultimate goal of dentistry. Premature loss of primary teeth is common due to caries, dental trauma or other causes. As the primary teeth are the best space maintainers, teeth with infected pulps should be retained until exfoliation, whenever possible. Aim The purpose of this in vivo study was to evaluate and compare the efficacy of different obturating methods used in primary teeth. Materials and Methods Forty one patients aged four to nine years with a total of 60 teeth were selected. Out of the 60 teeth, 32 were primary mandibular first molars and 28 were primary mandibular second molars, the sample was randomly divided into three groups. Disposable syringe, lentulo spiral and past inject were used for obturation. Postoperative evaluation was done for; quality of canal obturation, presence of voids using postoperative radiographs following obturation of teeth. The data were analysed to assess the success rate of the three methods used for obturation using Chi-square test. Results Among the three groups of the study, past inject exhibited the maximum number of optimally filled canals. Maximum number of underfilled canals was found with lentulospiral, and the maximum number of overfilled canals was seen with disposable syringe. Least number of voids was observed in canals filled with the past inject technique and disposable syringe. Conclusion The results suggest that the most successful technique for obturation of primary teeth was past inject. PMID:28893042

State of personal hygiene among primary school children: A community based cohort study.

PubMed

Ahmadu, Baba Usman; Rimamchika, Musa; Ibrahim, Ahmad; Nnanubumom, Andy Angela; Godiya, Andrew; Emmanuel, Pembi

2013-01-01

Good personal hygiene in primary school children could be effective towards preventing infectious diseases. This work examined personal cleanliness of primary school children in Banki based on the following variables: bathing, state of uniforms, hair, nails and oral hygiene. One hundred and fifty primary school children in Banki community were selected using the cluster random sampling method. Analysis of variance was used to compare means and to test for significance of data, and coefficient of correlation to investigate the relationship between cleanliness and age of subjects. There were 87 (58 %) boys and 63 (42 %) girls in a ratio of 1.4:1. Ninety six (64 %) pupils belong to low socioeconomic class. Whereas, 53 (35.3 %) were found within 11-13 years age group, the overall mean age was 9 years (Standard deviation [SD] was 2.2), 95 CI (7.0 - 11.0) years. Comparing means for the different categories of personal hygiene, there was significant difference (F= 61.47, p < 0.0001). General personal cleanliness in our participants improved with age, and a positive significant correlation was observed between age and personal cleanliness in (r = 0.971, p = 0.026). In conclusion, significant number of primary school pupils in Banki community had good personal hygiene, which was observed to be directly proportional with age. Therefore, all efforts towards quality health education on personal hygiene as a means of primary prevention of illnesses in primary school pupils should be sustained.

Improving Learning in Primary Schools of Developing Countries: A Meta-Analysis of Randomized Experiments

ERIC Educational Resources Information Center

McEwan, Patrick J.

2015-01-01

I gathered 77 randomized experiments (with 111 treatment arms) that evaluated the effects of school-based interventions on learning in developing-country primary schools. On average, monetary grants and deworming treatments had mean effect sizes that were close to zero and not statistically significant. Nutritional treatments, treatments that…

Selection of Aptamers for Mature White Adipocytes by Cell SELEX Using Flow Cytometry

PubMed Central

Kim, Eun Young; Kim, Ji Won; Kim, Won Kon; Han, Baek Soo; Park, Sung Goo; Chung, Bong Hyun; Lee, Sang Chul; Bae, Kwang-Hee

2014-01-01

Background Adipose tissue, mainly composed of adipocytes, plays an important role in metabolism by regulating energy homeostasis. Obesity is primarily caused by an abundance of adipose tissue. Therefore, specific targeting of adipose tissue is critical during the treatment of obesity, and plays a major role in overcoming it. However, the knowledge of cell-surface markers specific to adipocytes is limited. Methods and Results We applied the CELL SELEX (Systematic Evolution of Ligands by EXponential enrichment) method using flow cytometry to isolate molecular probes for specific recognition of adipocytes. The aptamer library, a mixture of FITC-tagged single-stranded random DNAs, is used as a source for acquiring molecular probes. With the increasing number of selection cycles, there was a steady increase in the fluorescence intensity toward mature adipocytes. Through 12 rounds of SELEX, enriched aptamers showing specific recognition toward mature 3T3-L1 adipocyte cells were isolated. Among these, two aptamers (MA-33 and 91) were able to selectively bind to mature adipocytes with an equilibrium dissociation constant (Kd) in the nanomolar range. These aptamers did not bind to preadipocytes or other cell lines (such as HeLa, HEK-293, or C2C12 cells). Additionally, it was confirmed that MA-33 and 91 can distinguish between mature primary white and primary brown adipocytes. Conclusions These selected aptamers have the potential to be applied as markers for detecting mature white adipocytes and monitoring adipogenesis, and could emerge as an important tool in the treatment of obesity. PMID:24844710

47 CFR 1.1604 - Post-selection hearings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Post-selection hearings. 1.1604 Section 1.1604 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1604 Post-selection hearings. (a) Following the random...

47 CFR 1.1604 - Post-selection hearings.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Post-selection hearings. 1.1604 Section 1.1604 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1604 Post-selection hearings. (a) Following the random...

Vibegron, a Novel Potent and Selective β3-Adrenoreceptor Agonist, for the Treatment of Patients with Overactive Bladder: A Randomized, Double-blind, Placebo-controlled Phase 3 Study.

PubMed

Yoshida, Masaki; Takeda, Masayuki; Gotoh, Momokazu; Nagai, Shinji; Kurose, Takafumi

2018-05-01

Vibegron is a novel, potent, and selective β 3 -adrenoreceptor agonist for the treatment of patients with overactive bladder (OAB). To evaluate the efficacy and safety of vibegron versus placebo in Japanese OAB patients. Patients with OAB entered a 2-wk placebo run-in phase. Once eligibility (≥8 micturition/d and either ≥1 urgency episodes/d or ≥1 urgency incontinence episodes/d) was confirmed, patients entered a 12-wk double-blind treatment phase. The anticholinergic imidafenacin was used as an active reference. A total of 1232 patients were randomly assigned to one of the four 12-wk treatment groups: vibegron (50mg or 100mg once daily), placebo, or imidafenacin (0.1mg twice daily). The primary endpoint was change in the mean number of micturitions/d at wk 12 from baseline. The secondary endpoints were changes from baselines in OAB symptom variables (daily episodes of urgency, urgency incontinence, incontinence, and nocturia, and voided volume/micturition). Quality of life (QoL) and safety were assessed. A constrained longitudinal data analysis model was used for analysis of efficacy. Patients taking vibegron 50mg and 100mg orally for 12 wk had significant improvements over the placebo in the primary and secondary endpoints. The proportions of patients with normalization of micturition, resolution of urgency, urgency incontinence, and incontinence were significantly greater than placebo. Vibegron significantly improved QoL, with high patient satisfaction. Incidences of drug-related adverse events with vibegron 50mg and 100mg were 7.6%, 5.4%, similar to placebo (5.1%), and less than imidafenacin (10.3%). Treatment was for just 12 wk and a long-term study is needed. The 12-wk treatment with vibegron is effective and well tolerated in patients with OAB. This randomized study demonstrated that vibegron is clinically useful for treatment of patients with OAB. Trial registration ​JapicCTI-152936. http://www.clinicaltrials.jp/user/cteDetail.jsp. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Effectiveness of a selective intervention program targeting personality risk factors for alcohol misuse among young adolescents: results of a cluster randomized controlled trial.

PubMed

Lammers, Jeroen; Goossens, Ferry; Conrod, Patricia; Engels, Rutger; Wiers, Reinout W; Kleinjan, Marloes

2015-07-01

The effectiveness of Preventure was tested on drinking behaviour of young adolescents in secondary education in the Netherlands. A cluster randomized controlled trial was carried out, with participants assigned randomly to a two-session coping skills intervention or a control no-intervention condition. Fifteen secondary schools throughout the Netherlands; seven schools in the intervention and eight schools in the control condition. A total of 699 adolescents aged 13-15 years participated, 343 allocated to the intervention and 356 to the control condition, with drinking experience and elevated scores in either negative thinking, anxiety sensitivity, impulsivity or sensation-seeking. Preventure is a selective school-based alcohol prevention programme targeting personality risk factors. The comparator was a no-intervention control. The effects of the intervention on the primary outcome past-month binge drinking, and the secondary outcomes binge drinking frequency, alcohol use, alcohol frequency and problem drinking, were examined. The primary analyses of interest were intervention main effects at 12 months post-intervention. In addition, intervention effects on the linear development of binge drinking using a latent-growth curve approach were examined. Binge drinking rates were not significantly different between the intervention (42.9%) and control group (49.2%) at 12 months follow-up [odds ratio (OR) = 1.05, confidence interval (CI) = 0.99, 1.11]. Intention-to-treat analyses revealed no significant intervention effects on alcohol use (53.9 versus 61.5%; OR = 0.99, CI = 0.86, 1.14) and problem drinking (37.0 versus 44.7%; OR = 1.03, CI = 0.92, 1.10) at 12 months follow-up. The post-hoc latent-growth analyses revealed significant effects on the development of binge drinking (β = -0.16, P = 0.05), and binge drinking frequency (β = -0.14, P = 0.05). The alcohol prevention programme, Preventure, appears to have little or no effect on overall prevalence of binge drinking in adolescents in the Netherlands but may reduce the development of binge drinking over time. © 2015 Society for the Study of Addiction.

Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial.

PubMed

Tingey, Lauren; Chambers, Rachel; Goklish, Novalene; Larzelere, Francene; Lee, Angelita; Suttle, Rosemarie; Rosenstock, Summer; Lake, Kristin; Barlow, Allison

2017-02-27

American Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents have the highest substance use-related morbidity and mortality of any US racial group. Despite these disparities, there are no existing, evidence-based programs for pregnancy prevention that have been rigorously evaluated among American Indian teens. The proposed study is a randomized controlled trial to test the efficacy of a comprehensive sexual and reproductive health program developed in partnership with an American Indian community. Participants will be American Indians ages 11-19 and their parent or trusted adult, randomized to receive the control condition or intervention called Respecting the Circle of Life: Mind, Body and Spirit. The intervention includes eight lessons delivered to self-selected peer groups during a summer basketball camp and one lesson delivered to the youth and parent/trusted adult together within 3 months after camp. All lessons are administered by trained community health workers from the participating American Indian community. Youth and parent/trusted adult participants will complete assessments at baseline, 3, 9, 12, 24 and 36 months post-intervention completion. The primary outcome variables are sexual/reproductive health knowledge, sexual initiation, condom use self-efficacy and intent to use a condom at next sex as changed from baseline to post-intervention between intervention and control participants. Selected primary outcomes are applicable to all study participants. Currently there are no sexual and reproductive health programs designed specifically for American Indian youth that have been rigorously evaluated and found to have an evidence base. Respecting the Circle of Life is highly innovative by incorporating lesson delivery into a summer basketball camp and involving parents or other trusted adults in curriculum administration. If found successful, it will be the first evidence-based program for teen pregnancy prevention for American Indian youth and adolescents. Clinicaltrials.gov, NCT02904629 . Retrospectively registered on 23 September 2016.

REDUCING SUICIDAL IDEATION AND DEPRESSION IN OLDER PRIMARY CARE PATIENTS: 24-MONTH OUTCOMES OF THE PROSPECT STUDY

PubMed Central

Alexopoulos, George S.; Reynolds, Charles F.; Bruce, Martha L.; Katz, Ira R.; Raue, Patrick J.; Mulsant, Benoit H.; Oslin, David; Have, Thomas Ten

2010-01-01

Objective The PROSPECT Study evaluated the impact of a care management intervention on suicidal ideation and depression in older primary care patients. This is the first report of outcomes over a 2-year period. Method The subjects (N=599) were older (>=60 years) patients with major or minor depression selected after screening 9,072 randomly identified patients of 20 primary care practices randomly assigned to the PROSPECT intervention or usual care. The intervention consisted of services of 15 trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 24 months. Results Intervention patients had a higher likelihood to receive antidepressants and or psychotherapy (84.9–89% vs. 49–59%) and a 2.2 times greater decline in suicidal ideation than usual care patients over 24 months. Treatment response occurred earlier in intervention patients and continued to increase from the 18th to the 24th month, while there was no appreciable increase in usual care patients during the same period. Among patients with major depression, a greater number achieved remission in the intervention than the usual care group at 4 (26.6 vs. 15.2%), 8 (36% vs. 22.5%), and 24 (45.4% vs. 31.5%) months. Patients with minor depression had favorable outcomes regardless of treatment assignment. Conclusions Sustained collaborative care maintains high utilization of antidepressant treatment, reduces suicidal ideation, and improves the outcomes of major depression over two years. These observations suggest that sustained collaborative care increases depression-free days. PMID:19528195

Do primary health care nurses address cardiovascular risk in diabetes patients?

PubMed

Daly, Barbara; Kenealy, Timothy; Arroll, Bruce; Sheridan, Nicolette; Scragg, Robert

2014-11-01

To identify factors associated with assessment and nursing management of blood pressure, smoking and other major cardiovascular risk factors by primary health care nurses in Auckland, New Zealand. Primary health care nurses (n = 287) were randomly sampled from the total (n=1091) identified throughout the Auckland region and completed a self-administered questionnaire (n = 284) and telephone interview. Nurses provided details for 86% (n =265) of all diabetes patients they consulted on a randomly selected day. The response rate for nurses was 86%. Of the patients sampled, 183 (69%) patients had their blood pressure measured, particularly if consulted by specialist (83%) and practice (77%) nurses compared with district (23%, p = 0.0003). After controlling for demographic variables, multivariate analyses showed patients consulted by nurses who had identified stroke as a major diabetes-related complication were more likely to have their blood pressure measured, and those consulted by district nurses less likely. Sixteen percent of patients were current smokers. Patients consulted by district nurses were more likely to smoke while, those >66 years less likely. Of those who wished to stop, only 50% were offered nicotine replacement therapy. Patients were significantly more likely to be advised on diet and physical activity if they had their blood pressure measured (p < 0.0001). Measurement of blood pressure and advice on diet or physical activity were not related to patient's cardiovascular risk profile and management of smoking cessation was far from ideal. Education of the community-based nursing workforce is essential to ensure cardiovascular risk management becomes integrated into diabetes management. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial of exercise therapy for dizziness and vertigo in primary care.

PubMed Central

Yardley, L; Beech, S; Zander, L; Evans, T; Weinman, J

1998-01-01

BACKGROUND: 'Vestibular rehabilitation' (VR) is an increasingly popular treatment option for patients with persistent dizziness. Previous clinical trials have only evaluated the effects of specialist therapy programmes in small, selective, or uncontrolled patient samples. AIM: To determine the benefits of VR compared with standard medical care, using a brief intervention for dizzy patients in primary care. METHOD: Adults consulting their general practitioner (GP) with dizziness or vertigo were randomly assigned to treatment or control groups. Patients in both groups received the same evaluation at baseline, six-week follow-up, and six-month follow-up, comprising examination of nystagmus, postural control, and movement-provoked dizziness, and a questionnaire assessment of subjective status, symptoms, handicap, anxiety, and depression. At baseline and six weeks later, the treatment group also received an individualized 30-minute therapy session, in which they were taught head, eye, and body exercises designed to promote vestibular compensation and enhance skill and confidence in balance. RESULTS: The treatment group (n = 67) improved on all measures, whereas the control group (n = 76) showed no improvement, resulting in a significant difference between the two groups on physical indices of balance and subjective indices of symptoms and distress. Odds ratios for improvement in treated patients relative to untreated patients were 3.1:1 at six weeks (95% CI = 1.4-6.8) and 3.8:1 at six months (95% CI = 1.6-8.7). CONCLUSION: VR is a simple, inexpensive, and beneficial treatment, and may be an appropriate first stage of management for many dizzy patients in primary care. PMID:9667087

Evaluation of the Effect of Decision Support on the Efficiency of Primary Care Providers in the Outpatient Practice

PubMed Central

Hankey, Ronald A.; Decker, Lindsay K.; Cha, Stephen S.; Greenes, Robert A.; Liu, Hongfang; Chaudhry, Rajeev

2015-01-01

Background: Clinical decision support (CDS) for primary care has been shown to improve delivery of preventive services. However, there is little evidence for efficiency of physicians due to CDS assistance. In this article, we report a pilot study for measuring the impact of CDS on the time spent by physicians for deciding on preventive services and chronic disease management. Methods: We randomly selected 30 patients from a primary care practice, and assigned them to 10 physicians. The physicians were requested to perform chart review to decide on preventive services and chronic disease management for the assigned patients. The patients assignment was done in a randomized crossover design, such that each patient received 2 sets of recommendations—one from a physician with CDS assistance and the other from a different physician without CDS assistance. We compared the physician recommendations made using CDS assistance, with the recommendations made without CDS assistance. Results: The physicians required an average of 1 minute 44 seconds, when they were they had access to the decision support system and 5 minutes when they were unassisted. Hence the CDS assistance resulted in an estimated saving of 3 minutes 16 seconds (65%) of the physicians’ time, which was statistically significant (P < .0001). There was no statistically significant difference in the number of recommendations. Conclusion: Our findings suggest that CDS assistance significantly reduced the time spent by physicians for deciding on preventive services and chronic disease management. The result needs to be confirmed by performing similar studies at other institutions. PMID:25155103

A nationwide population-based study on incidence and cost of non-fatal injuries in Iran.

PubMed

Hafezi-Nejad, Nima; Rahimi-Movaghar, Afarin; Motevalian, Abbas; Amin-Esmaeili, Masoumeh; Sharifi, Vandad; Hajebi, Ahmad; Radgoodarzi, Reza; Hefazi, Mitra; Eslami, Vahid; Saadat, Soheil; Rahimi-Movaghar, Vafa

2014-10-01

Elucidating the epidemiological status of injuries is a critical component of preventive strategies in countries with high incidence of injuries, like Iran. Population-based surveys are able to estimate all types of non-fatal injuries. This study protocol is the core unit in describing Iran's national cost and epidemiology of non-fatal injuries, and also as a guide for other studies. In a cross-sectional study, 1525 primary sampling units are randomly selected with probability proportional to size regarding the number of households in each enumeration area based on Iran's 2006 national census. Six of the households are randomly selected. One member of each household is chosen using Kish Grid tables. In all, 9150 subjects are selected. Data on demographics are collected. For each injury during the past three months, activity, place, mechanism, site, type and the place of treatment are coded to match the International Classification of Diseases, 10th revision 2012 (ICD10-2012) classifications. Subjects are contacted via telephone to obtain data on cost of injury. Finally, sampling weights are calculated so that data for each respondent can be inflated to represent other individuals in Iran. Quality control and quality assurance issues are discussed. Our objectives will describe the present impact and the future priorities of injury prevention in Iran. 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.

A randomized controlled trial investigating the use of a predictive nomogram for the selection of the FSH starting dose in IVF/ICSI cycles.

PubMed

Allegra, Adolfo; Marino, Angelo; Volpes, Aldo; Coffaro, Francesco; Scaglione, Piero; Gullo, Salvatore; La Marca, Antonio

2017-04-01

The number of oocytes retrieved is a relevant intermediate outcome in women undergoing IVF/intracytoplasmic sperm injection (ICSI). This trial compared the efficiency of the selection of the FSH starting dose according to a nomogram based on multiple biomarkers (age, day 3 FSH, anti-Müllerian hormone) versus an age-based strategy. The primary outcome measure was the proportion of women with an optimal number of retrieved oocytes defined as 8-14. At their first IVF/ICSI cycle, 191 patients underwent a long gonadotrophin-releasing hormone agonist protocol and were randomized to receive a starting dose of recombinant (human) FSH, based on their age (150 IU if ≤35 years, 225 IU if >35 years) or based on the nomogram. Optimal response was observed in 58/92 patients (63%) in the nomogram group and in 42/99 (42%) in the control group (+21%, 95% CI = 0.07 to 0.35, P = 0.0037). No significant differences were found in the clinical pregnancy rate or the number of embryos cryopreserved per patient. The study showed that the FSH starting dose selected according to ovarian reserve is associated with an increase in the proportion of patients with an optimal response: large trials are recommended to investigate any possible effect on the live-birth rate. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Development and testing of a scale for assessing the quality of home nursing.

PubMed

Chiou, Chii-Jun; Wang, Hsiu-Hung; Chang, Hsing-Yi

2016-03-01

To develop a home nursing quality scale and to evaluate its psychometric properties. This was a 3-year study. In the first year, 19 focus group interviews with caregivers of people using home nursing services were carried out in northern, central and southern Taiwan. Content analysis was carried out and a pool of questionnaire items compiled. In the second year (2007), study was carried out on a stratified random sample selected from home nursing organizations covered by the national health insurance scheme in southern Taiwan. The study population was the co-resident primary caregivers of home care nursing service users. Item analysis and exploratory factor analysis were carried out on data from 365 self-administered questionnaires collected from 13 selected home care organizations. In the third year (2008), a random sample of participants was selected from 206 hospital-based home care nursing organizations throughout Taiwan, resulting in completion of 294 questionnaires from 27 organizations. Confirmatory factor analysis was then carried out on the scale, and the validity and reliability of the scale assessed. The present study developed a reliable and valid home nursing quality scale from the perspective of users of home nursing services. The scale comprised three factors: dependability, communication skills and service usefulness. This scale is of practical value for the promotion of long-term community care aging in local policies. The scale is ready to be used to assess the quality of services provided by home care nursing organizations. © 2015 Japan Geriatrics Society.

Systematic Review of Interventions to Improve the Provision of Information for Adults with Primary Brain Tumors and Their Caregivers

PubMed Central

Langbecker, Danette; Janda, Monika

2014-01-01

Background: Adults with primary brain tumors and their caregivers have significant information needs. This review assessed the effect of interventions to improve information provision for adult primary brain tumor patients and/or their caregivers. Methods: We included randomized or non-randomized trials testing educational interventions that had outcomes of information provision, knowledge, understanding, recall, or satisfaction with the intervention, for adults diagnosed with primary brain tumors and/or their family or caregivers. PubMed, MEDLINE, EMBASE, and Cochrane Reviews databases were searched for studies published between 1980 and June 2014. Results: Two randomized controlled, 1 non-randomized controlled, and 10 single group pre–post trials enrolled more than 411 participants. Five group, four practice/process change, and four individual interventions assessed satisfaction (12 studies), knowledge (4 studies), and information provision (2 studies). Nine studies reported high rates of satisfaction. Three studies showed statistically significant improvements over time in knowledge and two showed greater information was provided to intervention than control group participants, although statistical testing was not performed. Discussion: The trials assessed intermediate outcomes such as satisfaction, and only 4/13 reported on knowledge improvements. Few trials had a randomized controlled design and risk of bias was either evident or could not be assessed in most domains. PMID:25667919

Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial.

PubMed

Rees, Clare M; Eaton, Simon; Kiely, Edward M; Wade, Angie M; McHugh, Kieran; Pierro, Agostino

2008-07-01

To determine whether primary peritoneal drainage improves survival and outcome of extremely low birth weight (ELBW) infants with intestinal perforation. Optimal surgical management of ELBW infants with intestinal perforation is unknown. An international multicenter randomized controlled trial was performed between 2002 and 2006. Inclusion criteria were birthweight >or=1000 g and pneumoperitoneum on x-ray (necrotizing enterocolitis or isolated perforation). Patients were randomized to peritoneal drain or laparotomy, minimizing differences in weight, gestation, ventilation, inotropes, platelets, country, and on-site surgical facilities. Patients randomized to drain were allowed to have a delayed laparotomy after at least 12 hours of no clinical improvement. Sixty-nine patients were randomized (35 drain, 34 laparotomy); 1 subsequently withdrew consent. Six-month survival was 18/35 (51.4%) with a drain and 21/33 (63.6%) with laparotomy (P = 0.3; difference 12% 95% CI, -11, 34%). Cox regression analysis showed no significant difference between groups (hazard ratio for primary drain 1.6; P = 0.3; 95% CI, 0.7-3.4). Delayed laparotomy was performed in 26/35 (74%) patients after a median of 2.5 days (range, 0.4-21) and did not improve 6-month survival compared with primary laparotomy (relative risk of mortality 1.4; P = 0.4; 95% CI, 0.6-3.4). Drain was effective as a definitive treatment in only 4/35 (11%) surviving neonates, the rest either had a delayed laparotomy or died. Seventy-four percent of neonates treated with primary peritoneal drainage required delayed laparotomy. There were no significant differences in outcomes between the 2 randomization groups. Primary peritoneal drainage is ineffective as either a temporising measure or definitive treatment. If a drain is inserted, a timely "rescue" laparotomy should be considered. Trial registration number ISRCTN18282954; http://isrctn.org/

Hyperparathyroidism in persons exposed to iodine-131 from the Hanford Nuclear Site.

PubMed

Hamilton, Thomas E; Davis, Scott; Onstad, Lynn; Kopecky, Kenneth J

2005-12-01

The risk of primary hyperparathyroidism from exposure to external radiation has been well documented in the last 20 yr. However, it remains unclear whether hyperparathyroidism might also be caused by internal exposure to radioactive iodine. The objective of this study was to determine whether exposure to 131I from the Hanford Nuclear Site during 1944-1957 increased the risk of hyperparathyroidism among people living in the area. The Hanford Thyroid Disease Study was conducted as a retrospective cohort study. The study setting was the general community in Washington State. The participants were 5199 persons born to mothers with usual residence in one of seven counties in eastern Washington State, randomly selected from birth records for the years 1940-1946. Of the 5199 selected, 3440 underwent a Hanford Thyroid Disease Study clinical evaluation, including an evaluation for hyperparathyroidism. Individual thyroid radiation dose, which could be estimated for 3191 study participants, ranged from 0.0029-2823 mGy (mean, 174 mGy). Hyperparathyroidism was the main outcome measure. Of 3440 evaluable participants, we confirmed 12 cases of primary hyperparathyroidism (0.35%). We found no evidence that the cumulative incidence of hyperparathyroidism increased with increasing radiation dose. In summary, this study shows no evidence that 131I, received at young ages and at the doses and exposure conditions experienced by this cohort, increased the risk of primary hyperparathyroidism. However, the effects of different doses and conditions of exposure to 131I on the risk of hyperparathyroidism remain to be defined.

Comparing the knowledge, attitude and practices of health care workers in public and private primary care facilities in Lagos State on Ebola virus disease.

PubMed

Idris, Bilqisu Jibril; Inem, Victor; Balogun, Mobolanle

2015-01-01

The West African sub-region is currently witnessing an outbreak of EVD that began in December 2013. The first case in Nigeria was diagnosed in Lagos, at a private medical facility in July 2014. Health care workers are known amplifiers of the disease. The study aimed to determine and compare EVD knowledge, attitude and practices among HCWs in public and private primary care facilities in Lagos, Nigeria. This was a comparative cross-sectional study. Seventeen public and private primary care facilities were selected from the 3 senatorial districts that make up Lagos State. 388 respondents from these facilities were selected at random and interviewed using a structured questionnaire. Proportion of respondents with good knowledge and practice among public HCWs was 98.5% and 93.8%; and among private HCW, 95.9% and 89.7%. Proportion of respondents with positive attitude was 67% (public) and 72.7% (private). Overall, there were no statistically significant differences between the knowledge, attitude and preventive practices of public HCWs and that of private HCWs, (p≤0.05). Timely and intense social mobilization and awareness campaigns are the best tools to educate all segments of the community about public health emergencies. There exists significant surmountable gaps in EVD knowledge, negative attitude and sub-standard preventive practices that can be eliminated through continued training of HCW and provision of adequate material resources.

Comparing the knowledge, attitude and practices of health care workers in public and private primary care facilities in Lagos State on Ebola virus disease

PubMed Central

Idris, Bilqisu Jibril; Inem, Victor; Balogun, Mobolanle

2015-01-01

Introduction The West African sub-region is currently witnessing an outbreak of EVD that began in December 2013. The first case in Nigeria was diagnosed in Lagos, at a private medical facility in July 2014. Health care workers are known amplifiers of the disease. The study aimed to determine and compare EVD knowledge, attitude and practices among HCWs in public and private primary care facilities in Lagos, Nigeria. Methods This was a comparative cross-sectional study. Seventeen public and private primary care facilities were selected from the 3 senatorial districts that make up Lagos State. 388 respondents from these facilities were selected at random and interviewed using a structured questionnaire. Results Proportion of respondents with good knowledge and practice among public HCWs was 98.5% and 93.8%; and among private HCW, 95.9% and 89.7%. Proportion of respondents with positive attitude was 67% (public) and 72.7% (private). Overall, there were no statistically significant differences between the knowledge, attitude and preventive practices of public HCWs and that of private HCWs, (p≤0.05). Conclusion Timely and intense social mobilization and awareness campaigns are the best tools to educate all segments of the community about public health emergencies. There exists significant surmountable gaps in EVD knowledge, negative attitude and sub-standard preventive practices that can be eliminated through continued training of HCW and provision of adequate material resources. PMID:26740847

Primary care access for new patients on the eve of health care reform.

PubMed

Rhodes, Karin V; Kenney, Genevieve M; Friedman, Ari B; Saloner, Brendan; Lawson, Charlotte C; Chearo, David; Wissoker, Douglas; Polsky, Daniel

2014-06-01

Current measures of access to care have intrinsic limitations and may not accurately reflect the capacity of the primary care system to absorb new patients. To assess primary care appointment availability by state and insurance status. We conducted a simulated patient study. Trained field staff, randomly assigned to private insurance, Medicaid, or uninsured, called primary care offices requesting the first available appointment for either routine care or an urgent health concern. The study included a stratified random sample of primary care practices treating nonelderly adults within each of 10 states (Arkansas, Georgia, Illinois, Iowa, Massachusetts, Montana, New Jersey, Oregon, Pennsylvania, and Texas), selected for diversity along numerous dimensions. Collectively, these states comprise almost one-third of the US nonelderly, Medicaid, and currently uninsured populations. Sampling was based on enrollment by insurance type by county. Analyses were weighted to obtain population-based estimates for each state. The ability to schedule an appointment and number of days to the appointment. We also examined cost and payment required at the visit for the uninsured. Between November 13, 2012, and April 4, 2013, we made 12,907 calls to 7788 primary care practices requesting new patient appointments. Across the 10 states, 84.7% (95% CI, 82.6%-86.8%) of privately insured and 57.9% (95% CI, 54.8%-61.0%) of Medicaid callers received an appointment. Appointment rates were 78.8% (95% CI, 75.6%-82.0%) for uninsured patients with full cash payment but only 15.4% (95% CI, 13.2%-17.6%) if payment required at the time of the visit was restricted to $75 or less. Conditional on getting an appointment, median wait times were typically less than 1 week (2 weeks in Massachusetts), with no differences by insurance status or urgency of health concern. Although most primary care physicians are accepting new patients, access varies widely across states and insurance status. Navigator programs are needed, not only to help patients enroll but also to identify practices accepting new patients within each plan's network. Tracking new patient appointment availability over time can inform policies designed to strengthen primary care capacity and enhance the effectiveness of the coverage expansions with the Patient Protection and Affordable Care Act.

Vitamin E in the prevention of cardiovascular disease: the importance of proper patient selection

PubMed Central

Vardi, Moshe; Levy, Nina S.; Levy, Andrew P.

2013-01-01

Vitamin E is a naturally occurring fat-soluble antioxidant which has been proposed as a treatment for both primary and secondary protection against cardiovascular (CV) events. Promising data from observational epidemiological studies associating higher vitamin E dietary intake with lower risk of CV events have not been validated in randomized controlled clinical trials assessing the effect of vitamin E on CV outcomes. While the pendulum of medical opinion has swung to suggest that high dose vitamin E supplements have no place in the treatment and prevention of CV disease, new data is emerging that allows identification of a specific target population for this treatment, namely patients with diabetes mellitus and the haptoglobin genotype 2-2. This review details the scientific basis and clinical evidence related to the effect of vitamin E on CV outcomes, and the importance of proper patient selection in gaining therapeutic benefit from this intervention. PMID:23505320

Biochemical Profile of Heritage and Modern Apple Cultivars and Application of Machine Learning Methods To Predict Usage, Age, and Harvest Season.

PubMed

Anastasiadi, Maria; Mohareb, Fady; Redfern, Sally P; Berry, Mark; Simmonds, Monique S J; Terry, Leon A

2017-07-05

The present study represents the first major attempt to characterize the biochemical profile in different tissues of a large selection of apple cultivars sourced from the United Kingdom's National Fruit Collection comprising dessert, ornamental, cider, and culinary apples. Furthermore, advanced machine learning methods were applied with the objective to identify whether the phenolic and sugar composition of an apple cultivar could be used as a biomarker fingerprint to differentiate between heritage and mainstream commercial cultivars as well as govern the separation among primary usage groups and harvest season. A prediction accuracy of >90% was achieved with the random forest method for all three models. The results highlighted the extraordinary phytochemical potency and unique profile of some heritage, cider, and ornamental apple cultivars, especially in comparison to more mainstream apple cultivars. Therefore, these findings could guide future cultivar selection on the basis of health-promoting phytochemical content.

Risk Factors for Uterine Atony/Postpartum Hemorrhage Requiring Treatment after Vaginal Delivery

PubMed Central

Wetta, Luisa A; Szychowski, Jeff M; Seals, Ms. Samantha; Mancuso, Melissa S; Biggio, Joseph R; Tita, Alan TN

2013-01-01

Objective To identify risk factors for uterine atony or hemorrhage. Study Design Secondary analysis of a 3-arm double-blind randomized trial of different dose-regimens of oxytocin to prevent uterine atony after vaginal delivery. The primary outcome was uterine atony or hemorrhage requiring treatment. Twenty-one potential risk factors were evaluated. Logistic regression was used to identify independent risk factors using 2 complementary pre-defined model selection strategies. Results Among 1798 women randomized to 10, 40 or 80U prophylactic oxytocin after vaginal delivery, treated uterine atony occurred in 7%. Hispanic (OR 2.1; 95% CI 1.3–3.4) and non-Hispanic whites (OR 1.6; 95% CI 1.0–2.5), preeclampsia (OR 3.2; 95% CI 2.0–4.9) and chorioamnionitis (OR 2.8; 95% CI 1.6–5.0) were consistent independent risk factors. Other risk factors based on the specified selection strategies were obesity, induction/augmentation of labor, twins, hydramnios, anemia, and arrest of descent. Amnioinfusion appeared to be protective against uterine atony (OR 0.53; 95% CI 0.29–0.98). Conclusion Independent risk factors for uterine atony requiring treatment include Hispanic and non-Hispanic white ethnicity, preeclampsia and chorioamnionitis. PMID:23507549

The Effect of Very High versus Very Low Sustained Loading on the Lower Back and Knees in Middle Life

PubMed Central

Milgrom, Yael; Constantini, Naama; Applbaum, Yaakov; Radeva-Petrova, Denitsa; Finestone, Aharon S.

2013-01-01

To evaluate the effect of the extremes of long term high and low physical activities on musculoskeletal heath in middle age, a historical cohort study was performed. The MRI knee and back findings of 25 randomly selected subjects who were inducted into the armed forces in 1983 and served at least 3 years as elite infantry soldiers were compared 25 years later, with 20 randomly selected subjects who were deferred from army service for full time religious studies at the same time. Both cohorts were from the same common genome. The two primary outcome measures were degenerative lumbar disc disease evaluated by the Pfirrmann score and degenerative knee changes evaluated by the WORMS score. At the 25-year follow up, the mean Pfirrmann score (8.6) for the L1 to S1 level of the elite infantry group was significantly higher than that of the sedentary group (6.7), (P = 0.003). There was no statistically significant difference between the WORMS knee scores between the two cohorts (P = 0.7). In spite of the much greater musculoskeletal loading history of the elite infantry cohort, only their lumbar spines but not their knees showed increased degenerative changes at middle age by MRI criteria. PMID:24093109

A prospective randomized multicentre study of the impact of gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging for staging high-risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): clinical trial protocol.

PubMed

Hofman, Michael S; Murphy, Declan G; Williams, Scott G; Nzenza, Tatenda; Herschtal, Alan; Lourenco, Richard De Abreu; Bailey, Dale L; Budd, Ray; Hicks, Rodney J; Francis, Roslyn J; Lawrentschuk, Nathan

2018-05-03

Accurate staging of patients with prostate cancer (PCa) is important for therapeutic decision-making. Relapse after surgery or radiotherapy of curative intent is not uncommon and, in part, represents a failure of staging with current diagnostic imaging techniques to detect disease spread. Prostate-specific membrane antigen (PSMA) positron-emission tomography (PET)/computed tomography (CT) is a new whole-body scanning technique that enables visualization of PCa with high contrast. The hypotheses of this study are that: (i) PSMA-PET/CT has improved diagnostic performance compared with conventional imaging; (ii) PSMA-PET/CT should be used as a first-line diagnostic test for staging; (iii) the improved diagnostic performance of PSMA-PET/CT will result in significant management impact; and (iv) there are economic benefits if PSMA-PET/CT is incorporated into the management algorithm. The proPSMA trial is a prospective, multicentre study in which patients with untreated high-risk PCa will be randomized to gallium-68-PSMA-11 PET/CT or conventional imaging, consisting of CT of the abdomen/pelvis and bone scintigraphy with single-photon emission CT/CT. Patients eligible for inclusion are those with newly diagnosed PCa with select high-risk features, defined as International Society of Urological Pathology grade group ≥3 (primary Gleason grade 4, or any Gleason grade 5), prostate-specific antigen level ≥20 ng/mL or clinical stage ≥T3. Patients with negative, equivocal or oligometastatic disease on first line-imaging will cross over to receive the other imaging arm. The primary objective is to compare the accuracy of PSMA-PET/CT with that of conventional imaging for detecting nodal or distant metastatic disease. Histopathological, imaging and clinical follow-up at 6 months will define the primary endpoint according to a predefined scoring system. Secondary objectives include comparing management impact, the number of equivocal studies, the incremental value of second-line imaging in patients who cross over, the cost of each imaging strategy, radiation exposure, inter-observer agreement and safety of PSMA-PET/CT. Longer-term follow-up will also assess the prognostic value of a negative PSMA-PET/CT. This trial will provide data to establish whether PSMA-PET/CT should replace conventional imaging in the primary staging of select high-risk localized PCa, or whether it should be used to provide incremental diagnostic information in selected cases. © 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.

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

Antonysamy, A.A., E-mail: alphons.antonysamy@GKNAerospace.com; Meyer, J., E-mail: jonathan.meyer@eads.com; Prangnell, P.B., E-mail: philip.prangnell@manchester.ac.uk

With titanium alloys, the solidification conditions in Additive Manufacturing (AM) frequently lead to coarse columnar β-grain structures. The effect of geometry on the variability in the grain structure and texture, seen in Ti-6Al-4V alloy components produced by Selective Electron Beam Melting (SEBM), has been investigated. Reconstruction of the primary β-phase, from α-phase EBSD data, has confirmed that in bulk sections where in-fill “hatching” is employed growth selection favours columnar grains aligned with an <001> {sub β} direction normal to the deposited powder layers; this results in a coarse β-grain structure with a strong < 001 > {sub β} fibre texturemore » (up 8 x random) that can oscillate between a near random distribution around the fibre axis and cube reinforcement with build height. It is proposed that this behaviour is related to the highly elongated melt pool and the raster directions alternating between two orthogonal directions every layer, which on average favours grains with cube alignment. In contrast, the outline, or “contour”, pass produces a distinctly different grain structure and texture resulting in a skin layer on wall surfaces, where nucleation occurs off the surrounding powder and growth follows the curved surface of the melt pool. This structure becomes increasingly important in thin sections. Local heterogeneities have also been found within different section transitions, resulting from the growth of skin grain structures into thicker sections. Texture simulations have shown that the far weaker α-texture (∼ 3 x random), seen in the final product, arises from transformation on cooling occurring with a near random distribution of α-plates across the 12 variants possible from the Burgers relationship. - Highlights: • Distinctly different skin and bulk structures are produced by the contour and hatching passes. • Bulk sections contain coarse β-grains with a < 001 > fibre texture in the build direction. • This oscillates between a random distribution around the axis and cube reinforcement. • In the skin layer nucleation occurs off the surrounding powder bed and growth occurs inwards. • Simulations show that a weak α-texture results from a random distribution across habit variants.« less

Efficacy and tolerability balance of oxycodone/naloxone and tapentadol in chronic low back pain with a neuropathic component: a blinded end point analysis of randomly selected routine data from 12-week prospective open-label observations.

PubMed

Ueberall, Michael A; Mueller-Schwefe, Gerhard H H

2016-01-01

To evaluate the benefit-risk profile (BRP) of oxycodone/naloxone (OXN) and tapentadol (TAP) in patients with chronic low back pain (cLBP) with a neuropathic component (NC) in routine clinical practice. This was a blinded end point analysis of randomly selected 12-week routine/open-label data of the German Pain Registry on adult patients with cLBP-NC who initiated an index treatment in compliance with the current German prescribing information between 1st January and 31st October 2015 (OXN/TAP, n=128/133). Primary end point was defined as a composite of three efficacy components (≥30% improvement of pain, pain-related disability, and quality of life each at the end of observation vs baseline) and three tolerability components (normal bowel function, absence of either central nervous system side effects, and treatment-emergent adverse event [TEAE]-related treatment discontinuation during the observation period) adopted to reflect BRP assessments under real-life conditions. Demographic as well as baseline and pretreatment characteristics were comparable for the randomly selected data sets of both index groups without any indicators for critical selection biases. Treatment with OXN resulted formally in a BRP noninferior to that of TAP and showed a significantly higher primary end point response vs TAP (39.8% vs 25.6%, odds ratio: 1.93; P =0.014), due to superior analgesic effects. Between-group differences increased with stricter response definitions for all three efficacy components in favor of OXN: ≥30%/≥50%/≥70% response rates for OXN vs TAP were seen for pain intensity in 85.2%/67.2%/39.1% vs 83.5%/54.1%/15.8% ( P = ns/0.031/<0.001), for pain-related disability in 78.1%/64.8%/43.8% vs 66.9%/50.4%/24.8% ( P =0.043/0.018/0.001), and for quality of life in 76.6%/68.0%/50.0% vs 63.9%/54.1%/34.6% ( P =0.026/0.022/0.017). Overall, OXN vs TAP treatments were well tolerated, and proportions of patients who either maintained a normal bowel function (68.0% vs 72.2%), reported no central nervous system side effects (91.4% vs 89.5%), or completed the 12-week evaluation period without any TEAE-related treatment discontinuations (93.0% vs 92.5%) were similar for both index medications ( P = ns for each comparison). In daily practice, the BRP of OXN proved to be noninferior to that of TAP in patients with cLBP-NC, but showed a superior efficacy if stricter analgesic response definitions were evaluated.

Efficacy and tolerability balance of oxycodone/naloxone and tapentadol in chronic low back pain with a neuropathic component: a blinded end point analysis of randomly selected routine data from 12-week prospective open-label observations

PubMed Central

Ueberall, Michael A; Mueller-Schwefe, Gerhard H H

2016-01-01

Objective To evaluate the benefit–risk profile (BRP) of oxycodone/naloxone (OXN) and tapentadol (TAP) in patients with chronic low back pain (cLBP) with a neuropathic component (NC) in routine clinical practice. Methods This was a blinded end point analysis of randomly selected 12-week routine/open-label data of the German Pain Registry on adult patients with cLBP-NC who initiated an index treatment in compliance with the current German prescribing information between 1st January and 31st October 2015 (OXN/TAP, n=128/133). Primary end point was defined as a composite of three efficacy components (≥30% improvement of pain, pain-related disability, and quality of life each at the end of observation vs baseline) and three tolerability components (normal bowel function, absence of either central nervous system side effects, and treatment-emergent adverse event [TEAE]-related treatment discontinuation during the observation period) adopted to reflect BRP assessments under real-life conditions. Results Demographic as well as baseline and pretreatment characteristics were comparable for the randomly selected data sets of both index groups without any indicators for critical selection biases. Treatment with OXN resulted formally in a BRP noninferior to that of TAP and showed a significantly higher primary end point response vs TAP (39.8% vs 25.6%, odds ratio: 1.93; P=0.014), due to superior analgesic effects. Between-group differences increased with stricter response definitions for all three efficacy components in favor of OXN: ≥30%/≥50%/≥70% response rates for OXN vs TAP were seen for pain intensity in 85.2%/67.2%/39.1% vs 83.5%/54.1%/15.8% (P= ns/0.031/<0.001), for pain-related disability in 78.1%/64.8%/43.8% vs 66.9%/50.4%/24.8% (P=0.043/0.018/0.001), and for quality of life in 76.6%/68.0%/50.0% vs 63.9%/54.1%/34.6% (P=0.026/0.022/0.017). Overall, OXN vs TAP treatments were well tolerated, and proportions of patients who either maintained a normal bowel function (68.0% vs 72.2%), reported no central nervous system side effects (91.4% vs 89.5%), or completed the 12-week evaluation period without any TEAE-related treatment discontinuations (93.0% vs 92.5%) were similar for both index medications (P= ns for each comparison). Conclusion In daily practice, the BRP of OXN proved to be noninferior to that of TAP in patients with cLBP-NC, but showed a superior efficacy if stricter analgesic response definitions were evaluated. PMID:27881925

Efficacy outcome selection in the therapeutic hypothermia after pediatric cardiac arrest trials.

PubMed

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

2015-01-01

The Therapeutic Hypothermia After Pediatric Cardiac Arrest trials will determine whether therapeutic hypothermia improves survival with good neurobehavioral outcome, as assessed by the Vineland Adaptive Behavior Scales Second Edition, in children resuscitated after cardiac arrest in the in-hospital and out-of-hospital settings. We describe the innovative efficacy outcome selection process during Therapeutic Hypothermia After Pediatric Cardiac Arrest protocol development. Consensus assessment of potential outcomes and evaluation timepoints. None. We evaluated practical and technical advantages of several follow-up timepoints and continuous/categorical outcome variants. Simulations estimated power assuming varying hypothermia benefit on mortality and on neurobehavioral function among survivors. Twelve months after arrest was selected as the optimal assessment timepoint for pragmatic and clinical reasons. Change in Vineland Adaptive Behavior Scales Second Edition from prearrest level, measured as quasicontinuous with death and vegetative status being worst-possible levels, yielded optimal statistical power. However, clinicians preferred simpler multicategorical or binary outcomes because of easier interpretability and favored outcomes based solely on postarrest status because of concerns about accurate parental assessment of prearrest status and differing clinical impact of a given Vineland Adaptive Behavior Scales Second Edition change depending on prearrest status. Simulations found only modest power loss from categorizing or dichotomizing quasicontinuous outcomes because of high expected mortality. The primary outcome selected was survival with 12-month Vineland Adaptive Behavior Scales Second Edition no less than two SD below a reference population mean (70 points), necessarily evaluated only among children with prearrest Vineland Adaptive Behavior Scales Second Edition greater than or equal to 70. Two secondary efficacy outcomes, 12-month survival and quasicontinuous Vineland Adaptive Behavior Scales Second Edition change from prearrest level, will be evaluated among all randomized children, including those with compromised function prearrest. Extensive discussion of optimal efficacy assessment timing, and of the advantages versus drawbacks of incorporating prearrest status and using quasicontinuous versus simpler outcomes, was highly beneficial to the final Therapeutic Hypothermia After Pediatric Cardiac Arrest design. A relatively simple, binary primary outcome evaluated at 12 months was selected, with two secondary outcomes that address the potential disadvantages of primary outcome.

Redesigning printed educational materials for primary care physicians: design improvements increase usability.

PubMed

Grudniewicz, Agnes; Bhattacharyya, Onil; McKibbon, K Ann; Straus, Sharon E

2015-11-04

Printed educational materials (PEMs) are a frequently used tool to disseminate clinical information and attempt to change behavior within primary care. However, their effect on clinician behavior is limited. In this study, we explored how PEMs can be redesigned to better meet the needs of primary care physicians (PCPs) and whether usability and selection can be increased when design principles and user preferences are used. We redesigned a publicly available PEM using physician preferences, design principles, and graphic designer support. We invited PCPs to select their preferred document between the redesigned and original versions in a discrete choice experiment, followed by an assessment of usability with the System Usability Scale and a think aloud process. We conducted this study in both a controlled and opportunistic setting to determine whether usability testing results vary by study location. Think aloud data was thematically analyzed, and results were interpreted using the Technology Acceptance Model. One hundred and eighty four PCPs participated in the discrete choice experiment at the 2014 Family Medicine Forum, a large Canadian conference for family physicians. Of these, 87.7 % preferred the redesigned version. Follow-up interviews were held with a randomly selected group of seven participants. We repeated this in a controlled setting in Toronto, Canada, with a set of 14 participants. Using the System Usability Scale, we found that usability scores were significantly increased with the redesign (p < 0.001). We also found that when PCPs were given the choice between the two versions, they selected the redesigned version as their preferred PEM more often than the original (p < 0.001). Results did not appear to differ between the opportunistic and controlled setting. We used the results of the think aloud process to add to a list of end user preferences developed in a previous study. We found that redesigning a PEM with user preferences and design principles can improve its usability and result in the PEM being selected more often than the original. We feel this finding supports the involvement of the user, application of design principles, and the assistance of a graphic designer in the development of PEMs.

Impact of communication strategies to increase knowledge, acceptability, and uptake of a new Woman's Condom in urban Lusaka, Zambia: study protocol for a randomized controlled trial.

PubMed

Pinchoff, Jessie; Chowdhuri, Rachna Nag; Taruberekera, Noah; Ngo, Thoai D

2016-12-13

Globally, 220 million women experience an unmet need for family planning. A newly designed female condom, the Woman's Condom (WC), has been developed featuring an improved design. It is the first dual-protection, female-initiated contraceptive that is a premium, higher price point product. However, market availability alone will not increase uptake. In February 2016 the WC will be distributed with a strong media campaign and interpersonal communication (IPC) outreach intervention. The impact of these on knowledge, acceptability, and use of the WC will be measured. A baseline survey of 2314 randomly selected 18- to 24-year-old sexually active men and women has been conducted. The WC and mass media will be introduced throughout 40 urban wards in and surrounding Lusaka, Zambia. The baseline survey will serve as a quasi-control arm to determine the impact of introducing the WC with mass media. Half of the wards will be randomly allocated to additionally receive the IPC intervention. A single-blind randomized controlled trial will determine the impact of the IPC intervention on knowledge, uptake, and use of the WC. After one year, another 2314 individuals will be randomly selected to participate in the endline survey. We hypothesize that (1) the distribution and media campaign of the WC will increase overall condom use in selected urban wards, and specifically use of the WC; (2) the IPC intervention will significantly impact knowledge, acceptability, and use of the WC. The primary outcome measures are use of the WC, use of any condom, and willingness to use the WC. Secondary outcomes include measures of knowledge, acceptability, and choice of contraception. Odds ratios will be estimated to measure the effect of the intervention on the outcomes with 95% confidence intervals. All analyses will be based on the intention-to-treat principle. Increasing uptake of dual prevention measures (such as the WC) may reduce incidence of sexually transmitted infections/HIV and unplanned pregnancies. It is important to ensure young, urban adults have access to new contraceptive methods; and, understanding how mass media and IPC impact contraceptive knowledge, acceptability, and use is critical to reduce unmet need. AEARCTR-0000899 . Registered on 26 October 2015.

An audit of the nature and impact of clinical coding subjectivity variability and error in otolaryngology.

PubMed

Nouraei, S A R; Hudovsky, A; Virk, J S; Chatrath, P; Sandhu, G S

2013-12-01

To audit the accuracy of clinical coding in otolaryngology, assess the effectiveness of previously implemented interventions, and determine ways in which it can be further improved. Prospective clinician-auditor multidisciplinary audit of clinical coding accuracy. Elective and emergency ENT admissions and day-case activity. Concordance between initial coding and the clinician-auditor multi-disciplinary teams (MDT) coding in respect of primary and secondary diagnoses and procedures, health resource groupings health resource groupings (HRGs) and tariffs. The audit of 3131 randomly selected otolaryngology patients between 2010 and 2012 resulted in 420 instances of change to the primary diagnosis (13%) and 417 changes to the primary procedure (13%). In 1420 cases (44%), there was at least one change to the initial coding and 514 (16%) health resource groupings changed. There was an income variance of £343,169 or £109.46 per patient. The highest rates of health resource groupings change were observed in head and neck surgery and in particular skull-based surgery, laryngology and within that tracheostomy, and emergency admissions, and specially, epistaxis management. A randomly selected sample of 235 patients from the audit were subjected to a second audit by a second clinician-auditor multi-disciplinary team. There were 12 further health resource groupings changes (5%) and at least one further coding change occurred in 57 patients (24%). These changes were significantly lower than those observed in the pre-audit sample, but were also significantly greater than zero. Asking surgeons to 'code in theatre' and applying these codes without further quality assurance to activity resulted in an health resource groupings error rate of 45%. The full audit sample was regrouped under health resource groupings 3.5 and was compared with a previous audit of 1250 patients performed between 2007 and 2008. This comparison showed a reduction in the baseline rate of health resource groupings change from 16% during the first audit cycle to 9% in the current audit cycle (P < 0.001). Otolaryngology coding is complex and susceptible to subjectivity, variability and error. Coding variability can be improved, but not eliminated through regular education supported by an audit programme. © 2013 John Wiley & Sons Ltd.

Primary repair of the anterior cruciate ligament: A paradigm shift.

PubMed

van der List, Jelle P; DiFelice, Gregory S

2017-06-01

Over the last century, many surgical treatments have been developed in the orthopedic field, including treatments of anterior cruciate ligament (ACL) injuries. These treatments ideally evolve in a process of trial and error with prospective comparison of new treatments to the current treatment standard. However, these evolutions are sometimes not linear and periodically undergo paradigm shifts. In this article, we review the evolution of ACL treatment and explain how it underwent a paradigm shift. Open primary ACL repair was the most common treatment in the 1970s and 1980s, but because multiple studies noted deterioration of outcomes at mid-term follow-up, in addition to several randomized clinical trials (RCTs) that noted better outcomes following ACL reconstruction, the open primary repair technique was abandoned. At the end of the primary repair era, however, several studies showed that outcomes of open primary repair were good to excellent and did not deteriorate when this technique was selectively performed in patients with proximal ACL tears, whereas primary repair led to disappointing and unpredictable results in patients with mid-substance tears. Unfortunately, enrollment of patients in the aforementioned RCTs was already finished, ultimately leading to abandoning of open primary repair, despite the advantages of ligament preservation. In this review, we discuss (I) why the evolution of ACL treatment underwent a paradigm shift, (II) which factors may have played a role in this and (III) what the future role of arthroscopic primary ACL repair is in the evolution of ACL treatments. Copyright © 2016. Published by Elsevier Ltd.

Prevalence of Head Lice Infestation and Its Associated Factors among Primary School Students in Iran: A Systematic Review and Meta-analysis.

PubMed

Moosazadeh, Mahmood; Afshari, Mahdi; Keianian, Hormoz; Nezammahalleh, Asghar; Enayati, Ahmad Ali

2015-12-01

Head lice infestation is one of the most important health problems, generally involving children aged 5-13 years. This study aims to estimate the prevalence of head lice infestation and its associated factors among primary school children using systematic review and meta-analysis methods. Different national and international databases were searched for selecting the relevant studies using appropriate keywords, Medical Subject Heading terms, and references. Relevant studies with acceptable quality for meta-analysis were selected having excluded duplicate and irrelevant articles, quality assessment, and application of inclusion/exclusion criteria. With calculating standard errors according to binomial distribution and also considering the Cochrane's Q test as well as I-squared index for heterogeneity, pediculosis prevalence rate was estimated using Stata SE V.11 software. Forty studies met the inclusion criteria of this review and entered into the meta-analysis including 200,306 individuals. Using a random effect model, the prevalence (95% confidence interval) of head lice infestation among primary school children was estimated as 1.6% (1.2-2.05), 8.8% (7.6-9.9), and 7.4% (6.6-8.2) for boys, girls, and all the students, respectively. The infestation rate was found to be associated with low educational level of parents, long hair, family size, mother's job (housewife), father's job (worker/unemployed), using a common comb, lack of bathrooms in the house, and a low frequency of bathing. This meta-analysis revealed that the prevalence of head lice infestation among Iranian primary school children is relatively high with more prevalence among girls. We also found that economic, social, cultural, behavioral, and hygienic factors are associated with this infestation.

Impact of Socioeconomic Status on the Diagnosis of Primary Open-Angle Glaucoma and Primary Angle Closure Glaucoma: A Nationwide Population-Based Study in Taiwan.

PubMed

Ko, Yu-Chieh; Hwang, De-Kuang; Chen, Wei-Ta; Lee, Ching-Chih; Liu, Catherine J

2016-01-01

To understand the impact of socioeconomic status (SES) on the diagnosis of primary open-angle glaucoma (POAG) and primary angle closure glaucoma (PACG) in Taiwan. Subjects with glaucoma were identified from the National Health Insurance Research Database of year 2006, which included one million randomly selected insurants. Individuals who had ≥4 ambulatory visits within one year which had the diagnosis code of POAG (ICD-9-CM 365.11 or 365.12) or PACG (365.23) and concurrent prescription of anti-glaucoma medication or surgery were selected. Individual SES was represented by monthly income calculated from the insurance premium. Neighborhood SES was defined based on neighborhood household income averages. Urbanization level of habitation was categorized into 3 levels. The odds ratio of having POAG or PACG in subjects with different SES was evaluated by using multiple logistic regression analysis. In total, 752 and 561 subjects with POAG and PACG, respectively, who were treated on a regular basis, were identified. The diagnosis of glaucoma was affected by age, gender, frequency of healthcare utilization, individual SES, and urbanization level of habitation. With the adjustment of age, gender, healthcare utilization, neighborhood SES and level of urbanization, subjects with lower income were more likely to be diagnosed as PACG, but less likely as POAG. Subjects with more frequent healthcare utilization were more likely to be diagnosed with glaucoma. Subjects with low SES were more susceptible to PACG, but subjects with high SES were more likely to be diagnosed as POAG. This information is useful for the design and target participant setting in glaucoma education and screening campaign to maximize the efficacy of limited resources in preventing glaucoma blindness.

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

PubMed

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

2017-10-01

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

Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

ERIC Educational Resources Information Center

Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

2012-01-01

This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

Cost-Effectiveness of Primary Care Management With or Without Early Physical Therapy for Acute Low Back Pain: Economic Evaluation of a Randomized Clinical Trial.

PubMed

Fritz, Julie M; Kim, Minchul; Magel, John S; Asche, Carl V

2017-03-01

Economic evaluation of a randomized clinical trial. Compare costs and cost-effectiveness of usual primary care management for patients with acute low back pain (LBP) with or without the addition of early physical therapy. Low back pain is among the most common and costly conditions encountered in primary care. Early physical therapy after a new primary care consultation for acute LBP results in small clinical improvement but cost-effectiveness of a strategy of early physical therapy is unknown. Economic evaluation was conducted alongside a randomized clinical trial of patients with acute, nonspecific LBP consulting a primary care provider. All patients received usual primary care management and education, and were randomly assigned to receive four sessions of physical therapy or usual care of delaying referral consideration to permit spontaneous recovery. Data were collected in a randomized trial involving 220 participants age 18 to 60 with LBP <16 days duration without red flags or signs of nerve root compression. The EuroQoL EQ-5D health states were collected at baseline and after 1-year and used to compute the quality adjusted life year (QALY) gained. Direct (health care utilization) and indirect (work absence or reduced productivity) costs related to LBP were collected monthly and valued using standard costs. The incremental cost-effectiveness ratio was computed as incremental total costs divided by incremental QALYs. Early physical therapy resulted in higher total 1-year costs (mean difference in adjusted total costs = $580, 95% CI: $175, $984, P = 0.005) and better quality of life (mean difference in QALYs = 0.02, 95% CI: 0.005, 0.35, P = 0.008) after 1-year. The incremental cost-effectiveness ratio was $32,058 (95% CI: $10,629, $151,161) per QALY. Our results support early physical therapy as cost-effective relative to usual primary care after 1 year for patients with acute, nonspecific LBP. 2.

A randomized trial of misoprostol versus extra-amniotic sodium chloride infusion with oxytocin for induction of labor.

PubMed

Buccellato, C A; Stika, C S; Frederiksen, M C

2000-05-01

Our purpose was to compare the efficacy and safety of misoprostol and extra-amniotic sodium chloride infusion with oxytocin for induction of labor. This randomized trial compared two methods of labor induction in women requiring cervical ripening. One hundred twenty-three women undergoing labor induction with a Bishop score < or =5 were randomly selected to receive either misoprostol, 50 microg intravaginally every 4 hours, or extra-amniotic sodium chloride infusion. The primary outcome variable was the time interval from induction to vaginal delivery. Sixty-one women received extra-amniotic sodium chloride infusion and 62 women received misoprostol. The mean time interval from the start of induction to vaginal delivery was 15.0 +/- 5.0 hours and 16.5 +/- 7.2 hours for the extra-amniotic infusion and misoprostol groups, respectively (P, not significant). The cesarean delivery rate was not significantly different between the 2 groups (32.8% for the extra-amniotic infusion group; 19.4% for the misoprostol group). Maternal and neonatal outcomes were similar between the 2 groups. Both methods of induction are equally efficacious and result in similar maternal and neonatal outcomes.

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

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

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

Costs of health care across primary care models in Ontario.

PubMed

Laberge, Maude; Wodchis, Walter P; Barnsley, Jan; Laporte, Audrey

2017-08-01

The purpose of this study is to analyze the relationship between newly introduced primary care models in Ontario, Canada, and patients' primary care and total health care costs. A specific focus is on the payment mechanisms for primary care physicians, i.e. fee-for-service (FFS), enhanced-FFS, and blended capitation, and whether providers practiced as part of a multidisciplinary team. Utilization data for a one year period was measured using administrative databases for a 10% sample selected at random from the Ontario adult population. Primary care and total health care costs were calculated at the individual level and included costs from physician services, hospital visits and admissions, long term care, drugs, home care, lab tests, and visits to non-medical health care providers. Generalized linear model regressions were conducted to assess the differences in costs between primary care models. Patients not enrolled with a primary care physicians were younger, more likely to be males and of lower socio-economic status. Patients in blended capitation models were healthier and wealthier than FFS and enhanced-FFS patients. Primary care and total health care costs were significantly different across Ontario primary care models. Using the traditional FFS as the reference, we found that patients in the enhanced-FFS models had the lowest total health care costs, and also the lowest primary care costs. Patients in the blended capitation models had higher primary care costs but lower total health care costs. Patients that were in multidisciplinary teams (FHT), where physicians are also paid on a blended capitation basis, had higher total health care costs than non-FHT patients but still lower than the FFS reference group. Primary care and total health care costs increased with patients' age, morbidity, and lower income quintile across all primary care payment types. The new primary care models were associated with lower total health care costs for patients compared to the traditional FFS model, despite higher primary care costs in some models.

Comparison of low-dose spinal anesthesia and single-shot femoral block combination with conventional dose spinal anesthesia in outpatient arthroscopic meniscus repair.

PubMed

Turhan, K S Cakar; Akmese, R; Ozkan, F; Okten, F F

2015-04-01

In the current prospective, randomized study, we aimed to compare the effects of low dose selective spinal anesthesia with 5 mg of hyperbaric bupivacaine and single-shot femoral nerve block combination with conventional dose selective spinal anesthesia in terms of intraoperative anesthesia characteristics, block recovery characteristics, and postoperative analgesic consumption. After obtaining institutional Ethics Committee approval, 52 ASA I-II patients aged 25-65, undergoing arthroscopic meniscus repair were randomly assigned to Group S (conventional dose selective spinal anesthesia with 10 mg bupivacaine) and Group FS (low-dose selective spinal anesthesia with 5mg bupivacaine +single-shot femoral block with 0.25% bupivacaine). Primary endpoints were time to reach T12 sensory block level, L2 regression, and complete motor block regression. Secondary endpoints were maximum sensory block level (MSBL); time to reach MSBL, time to first urination, time to first analgesic consumption and pain severity at the time of first mobilization. Demographic characteristics were similar in both groups (p > 0.05). MSBL and time to reach T12 sensory level were similar in both groups (p > 0.05). Time to reach L2 regression, complete motor block regression, and time to first micturition were significantly shorter; time to first analgesic consumption was significantly longer; and total analgesic consumption and severity of pain at time of first mobilization were significantly lower in Group FS (p < 0.05). The findings of the current study suggest that addition of single-shot femoral block to low dose spinal anesthesia could be an alternative to conventional dose spinal anesthesia in outpatient arthroscopic meniscus repair. NCT02322372.

Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis.

PubMed

Anheyer, Dennis; Leach, Matthew J; Klose, Petra; Dobos, Gustav; Cramer, Holger

2018-01-01

Background Mindfulness-based stress reduction/cognitive therapy are frequently used for pain-related conditions, but their effects on headache remain uncertain. This review aimed to assess the efficacy and safety of mindfulness-based stress reduction/cognitive therapy in reducing the symptoms of chronic headache. Data sources and study selection MEDLINE/PubMed, Scopus, CENTRAL, and PsychINFO were searched to 16 June 2017. Randomized controlled trials comparing mindfulness-based stress reduction/cognitive therapy with usual care or active comparators for migraine and/or tension-type headache, which assessed headache frequency, duration or intensity as a primary outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Tool. Results Five randomized controlled trials (two on tension-type headache; one on migraine; two with mixed samples) with a total of 185 participants were included. Compared to usual care, mindfulness-based stress reduction/cognitive therapy did not improve headache frequency (three randomized controlled trials; standardized mean difference = 0.00; 95% confidence interval = -0.33,0.32) or headache duration (three randomized controlled trials; standardized mean difference = -0.08; 95% confidence interval = -1.03,0.87). Similarly, no significant difference between groups was found for pain intensity (five randomized controlled trials; standardized mean difference = -0.78; 95% confidence interval = -1.72,0.16). Conclusions Due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.

Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

PubMed

Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

2002-05-01

Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

Survival of Fuji IX ART fillings in permanent teeth of primary school children in Tanzania.

PubMed

Kikwilu, E N; Mandari, G J; Honkala, E

2001-08-01

To evaluate the clinical performance of atraumatic restorative treatment (ART) fillings using Fuji IX as a filling material in field conditions. Longitudinal study of the ART fillings in permanent teeth of primary school children aged eight to fifteen years. Primary schools in Morogoro municipality, Tanzania. Standard 3 and 4 children in five primary schools randomly selected from a list of 36 primary schools of Morogoro municipality were examined for dental caries and periodontal conditions. All 296 carious lesions that were indicated for restoration were treated using ART approach according to the instructions given in the manual for ART approach for the control of dental caries. Essential measurements for treated teeth and cavity were taken. The cavities were filled with Fuji IX glass ionomer cement as per manufacturer's instructions. After one year, 238 restorations were evaluated using the criteria for evaluating ART restorations. Clinical appearance of the surface of the restorations. Ninety four per cent of the restorations evaluated were rated as good and intact, while 1.7% were rated as having slight defects that needed no repair, giving a one year survival rate of 96.1%. Mean working time was 14.5 minutes. The one-year survival rate of 96.1% is high enough to recommend wide use of ART in Tanzania. Town and municipal councils should be encouraged to adopt ART in their school oral health programmes.

Selective Acid Etching Improves the Bond Strength of Universal Adhesive to Sound and Demineralized Enamel of Primary Teeth.

PubMed

Antoniazzi, Bruna Feltrin; Nicoloso, Gabriel Ferreira; Lenzi, Tathiane Larissa; Soares, Fabio Zovico Maxnuck; Rocha, Rachel de Oliveira

To evaluate the influence of enamel condition and etching strategy on bond strength of a universal adhesive in primary teeth. Thirty-six primary molars were randomly assigned to six groups (n = 6) according to the enamel condition (sound [S] and demineralized [DEM]/cariogenic challenge by pH cycling prior to restorative procedures) and adhesive system (Scotchbond Universal Adhesive [SBU]) used in either etch-and-rinse (ER) or selfetching (SE) mode, with Clearfil SE Bond as the self-etching control. The adhesives were applied to flat enamel surfaces and composite cylinders (0.72 mm2) were built up. After 24-h storage in water, specimens were subjected to the microshear test. Bond strength (MPa) data were analyzed using two-way ANOVA and Tukey's post-hoc tests (α = 0.05). Significant differences were found considering the factors adhesive system (p = 0.003) and enamel condition (p = 0.001). Demineralized enamel negatively affected the bond strength, with μSBS values approximately 50% lower than those obtained for sound enamel. SBU performed better in etch-and-rinse mode, and the bond strength found for SBU applied in self-etching mode was similar to that of CSE. Enamel etching with phosphoric acid improves the bond strength of a universal adhesive system to primary enamel. Demineralized primary enamel results in lower bond strength.

Family medicine patients who use retail clinics have lower continuity of care.

PubMed

Rohrer, James E; Angstman, Kurt B; Garrison, Gregory M; Maxson, Julie A; Furst, Joseph W

2013-04-01

The purpose of this study was to compare continuity of care for family medicine patients using retail medicine clinics to continuity for patients not using retail clinics. Retail medicine clinics have become popular in some markets. However, their impact on continuity of care has not been studied. Electronic medical records of adult primary care patients seen in a large group practice in Minnesota in 2011 were analyzed for this study. Two randomly chosen groups of patients were selected (N = 400): those using 1 of 3 retail walk-in clinics staffed by nurse practitioners in addition to standard office care and a comparison group that only used standard office care. Continuity was measured as the percentage of visits that involved the primary care provider. We also compared patients who made zero visits to their primary care providers with those who made some visits to their primary care providers. Continuity of care was lower for patients who used retail clinics than for patients who did not use retail clinics (0.17 vs 0.44, mean difference 0.27). The percentage of patients who made zero visits to their primary care providers was 54.5 for users of retail clinics versus 31.0 for those who did not use retail clinics. Continuity of care should be monitored as retail medicine continues to expand.

Awareness in Primary School Teachers regarding Traumatic Dental Injuries in Children and Their Emergency Management: A Survey in South Jaipur.

PubMed

Nirwan, Mitakshara; Syed, Ather Ahmed; Chaturvedi, Shefali; Goenka, Puneet; Sharma, Swati

2016-01-01

Trauma to primary and permanent teeth and their supporting structures is one of the most common dental problems seen in children. The prognosis of traumatized teeth depends on timely attention with prompt and appropriate treatment, which often relies on knowledge of the teachers who may be present at the place of accidents. Thus, the aim of this study was to evaluate via a questionnaire the knowledge level of primary school teachers in South Jaipur regarding dental trauma. Questionnaire survey. A self-designed questionnaire was administered to 300 primary school teachers from 20 randomly selected private and semi-aided schools of South Jaipur. A total of 278 teachers responded to the survey. The collected data were subjected to statistical analysis. It was found that most of the respondents had accepted poor knowledge regarding dental trauma, with a mean knowledge of 10.56 ± 2.58. This study highlighted inadequate knowledge regarding emergency management of traumatic dental injuries, and teachers felt the need for training in the management of dental trauma as part of their training program. How to cite this article: Nirwan M, Syed AA, Chaturvedi S, Goenka P, Sharma S. Awareness in Primary School Teachers regarding Traumatic Dental Injuries in Children and Their Emergency Management: A Survey in South Jaipur. Int J Clin Pediatr Dent 2016;9(1):62-66.

Impact of a Pay-for-Performance Program on Care for Black Patients with Hypertension: Important Answers in the Era of the Affordable Care Act.

PubMed

Petersen, Laura A; Ramos, Kate Simpson; Pietz, Kenneth; Woodard, LeChauncy D

2017-06-01

Evaluate the effect of a pay-for-performance intervention on the quality of hypertension care provided to black patients and determine whether it produced risk selection. Primary data collected between 2007 and 2009 from Veterans Affairs physicians and their primary care panels. Nested study within a cluster randomized controlled trial of three types of financial incentives and no incentives (control). We compared the proportion of physicians' black patients meeting hypertension performance measures for baseline and final performance periods. We measured risk selection by comparing the proportion of patients who switched providers, patient visit frequency, and panel turnover. Due to limited power, we prespecified in the analysis plan combining the three incentive groups and oversampling black patients. Data collected electronically and by chart review. The proportion of black patients who achieved blood pressure control or received an appropriate response to uncontrolled blood pressure in the final period was 6.3 percent (95 percent confidence interval, 0.8-11.7 percent) greater for physicians who received an incentive than for controls. There was no difference between intervention and controls in the proportion of patients who switched providers, visit frequency, or panel turnover. A pay-for-performance intervention improved blood pressure control or appropriate response to uncontrolled blood pressure in black patients and did not produce risk selection. © Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

Geographic Distribution of Disease Mutations in the Ashkenazi Jewish Population Supports Genetic Drift over Selection

PubMed Central

Risch, Neil; Tang, Hua; Katzenstein, Howard; Ekstein, Josef

2003-01-01

The presence of four lysosomal storage diseases (LSDs) at increased frequency in the Ashkenazi Jewish population has suggested to many the operation of natural selection (carrier advantage) as the driving force. We compare LSDs and nonlysosomal storage diseases (NLSDs) in terms of the number of mutations, allele-frequency distributions, and estimated coalescence dates of mutations. We also provide new data on the European geographic distribution, in the Ashkenazi population, of seven LSD and seven NLSD mutations. No differences in any of the distributions were observed between LSDs and NLSDs. Furthermore, no regular pattern of geographic distribution was observed for LSD versus NLSD mutations—with some being more common in central Europe and others being more common in eastern Europe, within each group. The most striking disparate pattern was the geographic distribution of the two primary Tay-Sachs disease mutations, with the first being more common in central Europe (and likely older) and the second being exclusive to eastern Europe (primarily Lithuania and Russia) (and likely much younger). The latter demonstrates a pattern similar to two other recently arisen Lithuanian mutations, those for torsion dystonia and familial hypercholesterolemia. These observations provide compelling support for random genetic drift (chance founder effects, one ∼11 centuries ago that affected all Ashkenazim and another ∼5 centuries ago that affected Lithuanians), rather than selection, as the primary determinant of disease mutations in the Ashkenazi population. PMID:12612865

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

PubMed

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites. If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas. ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

Immediate total-body CT scanning versus conventional imaging and selective CT scanning in patients with severe trauma (REACT-2): a randomised controlled trial.

PubMed

Sierink, Joanne C; Treskes, Kaij; Edwards, Michael J R; Beuker, Benn J A; den Hartog, Dennis; Hohmann, Joachim; Dijkgraaf, Marcel G W; Luitse, Jan S K; Beenen, Ludo F M; Hollmann, Markus W; Goslings, J Carel

2016-08-13

Published work suggests a survival benefit for patients with trauma who undergo total-body CT scanning during the initial trauma assessment; however, level 1 evidence is absent. We aimed to assess the effect of total-body CT scanning compared with the standard work-up on in-hospital mortality in patients with trauma. We undertook an international, multicentre, randomised controlled trial at four hospitals in the Netherlands and one in Switzerland. Patients aged 18 years or older with trauma with compromised vital parameters, clinical suspicion of life-threatening injuries, or severe injury were randomly assigned (1:1) by ALEA randomisation to immediate total-body CT scanning or to a standard work-up with conventional imaging supplemented with selective CT scanning. Neither doctors nor patients were masked to treatment allocation. The primary endpoint was in-hospital mortality, analysed in the intention-to-treat population and in subgroups of patients with polytrauma and those with traumatic brain injury. The χ(2) test was used to assess differences in mortality. This trial is registered with ClinicalTrials.gov, number NCT01523626. Between April 22, 2011, and Jan 1, 2014, 5475 patients were assessed for eligibility, 1403 of whom were randomly assigned: 702 to immediate total-body CT scanning and 701 to the standard work-up. 541 patients in the immediate total-body CT scanning group and 542 in the standard work-up group were included in the primary analysis. In-hospital mortality did not differ between groups (total-body CT 86 [16%] of 541 vs standard work-up 85 [16%] of 542; p=0.92). In-hospital mortality also did not differ between groups in subgroup analyses in patients with polytrauma (total-body CT 81 [22%] of 362 vs standard work-up 82 [25%] of 331; p=0.46) and traumatic brain injury (68 [38%] of 178 vs 66 [44%] of 151; p=0.31). Three serious adverse events were reported in patients in the total-body CT group (1%), one in the standard work-up group (<1%), and one in a patient who was excluded after random allocation. All five patients died. Diagnosing patients with an immediate total-body CT scan does not reduce in-hospital mortality compared with the standard radiological work-up. Because of the increased radiation dose, future research should focus on the selection of patients who will benefit from immediate total-body CT. ZonMw, the Netherlands Organisation for Health Research and Development. Copyright © 2016 Elsevier Ltd. All rights reserved.

Alcohol Consumption Practices among Married Women of Reproductive Age in Nepal: A Population Based Household Survey

PubMed Central

Thapa, Narbada; Aryal, Krishna Kumar; Puri, Rupendra; Shrestha, Saraswoti; Shrestha, Sheela; Thapa, Pukar; Mehata, Suresh; Thapa, Pushpa; Banjara, Megha Raj; Stray-Pedersen, Babill

2016-01-01

Background Alcohol chemically known as ethanol, causes several health, economic and social consequences across the world. Literatures suggest potential harm of alcohol drinking by pregnant women especially to the fetus and the mother. Despite anumber of significant public health problems related to alcohol consumption, this area has been ignored in Nepal and information at the national level is limited. Thus this study aimed at finding the prevalence of alcohol consumption among married women of reproductive age. Methods A nationally representative household survey was carried out from April to August 2013 by taking 16 districts across all 15 eco administrative regions. From the selected districts, 86 village development committees and 14 municipalities were selected as primary sampling units using probability proportionate to size, followed by random selection of 3 wards from each primary sampling unit. Finally, 30 households within each ward were selected using systematic random sampling, and one married women of reproductive age from each household. A total of 9000 married women of reproductive age were interviewed using a semi-structured questionnaire, on alcohol consumption practices including environmental factors and socio demographic characteristics and were included in the analysis. Results National prevalence of alcohol consumption ever among married women of reproductive age was 24.7% (95% CI:21.7–28.0), last 12 months 17.9% (95% CI:15.3–20.7) and last 30 days (current drinking) 11.8% (95% CI:9.8–14.1). There was substantial variation among the districts ranging from 2% to 60%. Multivariable analysis suggests women with no education or within formal education, dalit and janajatis ethnicity, whose husbands drink alcohol, who brew alcohol at home and women from mountains were significantly at higher risk of consuming alcohol. Among the women who drank alcohol in last 12 months, a substantial proportion of them drank home brewed alcoholic beverages (95.9%, 95% CI:94.3–97.4). Conclusion Alcohol consumption was common practice among married women of reproductive age in Nepal with variation among the subgroups of population. Thus, further investigation and behavior change communication interventions to reduce alcohol consumption especially among the women with higher risk of drinking is essential. PMID:27035722

Randomized double-blind placebo-controlled multicenter evaluation of efficacy and dose finding of midodrine hydrochloride in women with mild to moderate stress urinary incontinence: a phase II study.

PubMed

Weil, E H; Eerdmans, P H; Dijkman, G A; Tamussino, K; Feyereisl, J; Vierhout, M E; Schmidbauer, C; Egarter, C; Kölle, D; Plasman, J E; Heidler, H; Abbühl, B E; Wein, W

1998-01-01

Midodrine is a potent and selective alpha1-receptor agonist and its potential to increase urethral closure pressure could be useful in the treatment of female stress incontinence. The aim of this randomized double-blind placebo-controlled multicenter study was to evaluate the efficacy and safety of midodrine for the treatment of stress urinary incontinence. The primary criterion of efficacy was the maximum urethral closure pressure at rest. Voiding diaries, symptom and incontinence questionnaires and patient/investigator global assessment were also used to evaluate its efficacy. After 4 weeks of treatment no significant changes in MUCP were found. The global assessment by the patient and investigator did indicate that patients on active treatment had a more positive assessment than the placebo group. In conclusion, midodrine did not cause significant improvements in urodynamic parameters, but there were subjective improvements in some of the patients in the treated groups. Furthermore midodrine was well tolerated.

The effect of grape seed extract on estrogen levels of postmenopausal women: a pilot study.

PubMed

Wahner-Roedler, Dietlind L; Bauer, Brent A; Loehrer, Laura L; Cha, Stephen S; Hoskin, Tanya L; Olson, Janet E

2014-06-01

The role of estrogens in breast cancer (BC) development is widely accepted, leading to the development of selective estrogen receptor modulators and aromatase inhibitors for BC treatment and prevention. However, because of potential adverse effects, healthy women with high risk of BC are hesitant to take them. Preliminary evidence from animal studies shows that grapes may have an aromatase-inhibiting effect, decreasing estrogen synthesis and increasing androgen precursors. We conducted a randomized, double-blind, dose-finding early-phase trial on the effect of grape seed extract (GSE) on estrogen levels. Postmenopausal women who met study inclusion criteria (N = 46) were randomly assigned to daily GSE at a dose of 200, 400, 600, or 800 mg for 12 weeks. Primary outcome was change in plasma levels of estrogen conjugates from baseline to 12 weeks posttreatment. Thirty-nine participants (84.8%) completed the study. GSE in the 4 daily doses did not significantly decrease estrogen or increase androgen precursors.

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

Columnar organization of orientation domains in V1

NASA Astrophysics Data System (ADS)

Liedtke, Joscha; Wolf, Fred

In the primary visual cortex (V1) of primates and carnivores, the functional architecture of basic stimulus selectivities appears similar across cortical layers (Hubel & Wiesel, 1962) justifying the use of two-dimensional cortical models and disregarding organization in the third dimension. Here we show theoretically that already small deviations from an exact columnar organization lead to non-trivial three-dimensional functional structures. We extend two-dimensional random field models (Schnabel et al., 2007) to a three-dimensional cortex by keeping a typical scale in each layer and introducing a correlation length in the third, columnar dimension. We examine in detail the three-dimensional functional architecture for different cortical geometries with different columnar correlation lengths. We find that (i) topological defect lines are generally curved and (ii) for large cortical curvatures closed loops and reconnecting topological defect lines appear. This theory extends the class of random field models by introducing a columnar dimension and provides a systematic statistical assessment of the three-dimensional functional architecture of V1 (see also (Tanaka et al., 2011)).

Teaching adolescents about changing bodies: Randomized controlled trial of an Internet puberty education and body dissatisfaction prevention program.

PubMed

Cousineau, Tara M; Franko, Debra L; Trant, Meredith; Rancourt, Diana; Ainscough, Jessica; Chaudhuri, Anamika; Brevard, Julie

2010-09-01

This study tested the efficacy of an Internet-based prevention program, Trouble on the Tightrope: In Search of Skateboard Sam, on pubertal knowledge, body esteem, and self-esteem. One hundred and ninety participants (mean age 11.6 years) were randomized to either an intervention or attention placebo control condition and were assessed at baseline, after three Internet-based sessions, and at 3-month follow-up. Although the primary hypotheses were not supported, exploratory moderator analyses indicated that the intervention was beneficial for select students. Specifically, pubertal status moderated the effects on weight-related body esteem and several domains of self-esteem, resulting in positive effects for participants in the intervention group who had begun puberty. Gender differences were found on self-esteem subscales, indicating more robust effects for girls than boys. Tailored Internet programs based on personal characteristics such as gender and pubertal status may be a fruitful area for future research with adolescents. Copyright © 2010 Elsevier Ltd. All rights reserved.

The effects of honey compared to silver sulfadiazine for the treatment of burns: A systematic review of randomized controlled trials.

PubMed

Aziz, Zoriah; Abdul Rasool Hassan, Bassam

2017-02-01

Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Primary Definitive Procedure versus Conventional Three-staged Procedure for the Management of Low-type Anorectal Malformation in Females: A Randomized Controlled Trial.

PubMed

Gupta, Alisha; Agarwala, Sandeep; Sreenivas, Vishnubhatla; Srinivas, Madhur; Bhatnagar, Veereshwar

2017-01-01

Females with Krickenbeck low-type anorectal malformations - vestibular fistula (VF) and perineal fistula (PF) - are managed either by a primary definitive or conventional three-staged approach. Ultimate outcome in these children may be affected by wound dehiscence leading to healing by fibrosis. Most of the literature favors one approach over other based on retrospective analysis of their outcomes. Whether a statistically significant difference in wound dehiscence rates between these approaches exists needed to be seen. A randomized controlled trial for girls <14 years with VF or PF was done. Random tables were used to randomize 33 children to Group I (primary procedure) and 31 to Group II (three-staged procedure). Statistical analysis was done for significance of difference ( P < 0.05) in the primary outcome (wound dehiscence) and secondary outcomes (immediate and early postoperative complications). Of the 64 children randomized, 54 (84%) had VF. Both groups were comparable in demography, clinical profile and age at surgery. The incidence of wound dehiscence (39.4% vs. 18.2%; P = 0.04), immediate postoperative complications (51.5% vs. 12.9%; P = 0.001), and early postoperative complications (42.4% vs. 12.9%; P = 0.01) was significantly higher in Group I as compared to Group II. Six of 13 children (46.2%) with dehiscence in Group I required a diverting colostomy to be made. Females with VF or PF undergoing primary definitive procedure have a significantly higher incidence of wound dehiscence ( P = 0.04), immediate ( P = 0.001) and early postoperative complications ( P = 0.01).

Evaluation of Buccal Infiltration with Articaine and Inferior Alveolar Nerve Block with Lignocaine for Pulp Therapy in Mandibular Primary Molars.

PubMed

Chopra, Radhika; Marwaha, Mohita; Bansal, Kalpana; Mittal, Meenu

2016-01-01

Failure of inferior alveolar nerve block in achieving profound anesthesia of the pulp due to various reasons has led to the introduction of more potent local anesthetic agents like articaine. This study was conducted to compare the efficacy of buccal infiltration with articaine in achieving pulpal anesthesia of primary molars as compared to inferior alveolar nerve block with lignocaine. 30 patients (4-8 years) with indication of pulp therapy in at least two mandibular primary molars were selected. Patients were randomly assigned to receive nerve block with lignocaine or infiltration with articaine on first appointment and the other solution on second appointment. All the pulpotomies and pulpectomies were performed by a pediatric dentist. Two researchers standing at a distance of 1.5 m recorded the Pain Scores and Sound, Eye, Motor (SEM) scores. After the completion of procedure, the patient was asked to record the Facial Image score and Heft-Parker Visual Analogue Score (HP-VAS). Pain Score recorded at the time of injection showed significantly more movements with block as compared to infiltration (p<0.001). SEM scores at time of pulp extirpation were also higher for block than infiltration (p<0.001). Articaine infiltration has the potential to replace inferior alveolar nerve block for primary mandibular molars.

Improving diabetes care at primary care level with a multistrategic approach: results of the DIAPREM programme.

PubMed

Prestes, Mariana; Gayarre, Maria A; Elgart, Jorge F; Gonzalez, Lorena; Rucci, Enzo; Paganini, Jose M; Gagliardino, Juan J

2017-09-01

To present results, 1 year postimplementation at primary care level, of an integrated diabetes care programme including systemic changes, education, registry (clinical, metabolic, and therapeutic indicators), and disease management (DIAPREM). We randomly selected and trained 15 physicians and 15 nurses from primary care units of La Matanza County (intervention-IG) and another 15 physicians/nurses to participate as controls (control-CG). Each physician-nurse team controlled and followed up 10 patients with type 2 diabetes for 1 year; both groups used structured medical records. Patients in IG had quarterly clinical appointments, whereas those in CG received traditional care. Statistical data analysis included parametric/nonparametric tests according to data distribution profile and Chi-squared test for proportions. After 12 months, the dropout rate was significantly lower in IG than in CG. Whereas in IG HbA1c, blood pressure and lipid profile levels significantly decreased, no changes were recorded in CG. Drug prescriptions showed no significant changes in IG except a decrease in oral monotherapy. DIAPREM is an expedient and simple multistrategic model to implement at the primary care level in order to decrease patient dropout and improve control and treatment adherence, and quality of care of people with diabetes.

Home range, den selection and habitat use of Carolina northern flying squirrels (Glaucomys sabrinus coloratus)

USGS Publications Warehouse

Diggins, Corinne A.; Silvis, Alexander; Kelly, Christine A.; Ford, W. Mark

2017-01-01

Context: Understanding habitat selection is important for determining conservation and management strategies for endangered species. The Carolina northern flying squirrel (CNFS; Glaucomys sabrinus coloratus) is an endangered subspecies found in the high-elevation montane forests of the southern Appalachians, USA. The primary use of nest boxes to monitor CNFS has provided biased information on habitat use for this subspecies, as nest boxes are typically placed in suitable denning habitat.Aims: We conducted a radio-telemetry study on CNFS to determine home range, den site selection and habitat use at multiple spatial scales.Methods: We radio-collared 21 CNFS in 2012 and 2014–15. We tracked squirrels to diurnal den sites and during night-time activity.Key results: The MCP (minimum convex polygon) home range at 95% for males was 5.2 ± 1.2 ha and for females was 4.0 ± 0.7. The BRB (biased random bridge) home range at 95% for males was 10.8 ± 3.8 ha and for females was 8.3 ± 2.1. Den site (n = 81) selection occurred more frequently in montane conifer dominate forests (81.4%) vs northern hardwood forests or conifer–northern hardwood forests (9.9% and 8.7%, respectively). We assessed habitat selection using Euclidean distance-based analysis at the 2nd order and 3rd order scale. We found that squirrels were non-randomly selecting for habitat at both 2nd and 3rd order scales.Conclusions: At both spatial scales, CNFS preferentially selected for montane conifer forests more than expected based on availability on the landscape. Squirrels selected neither for nor against northern hardwood forests, regardless of availability on the landscape. Additionally, CNFS denned in montane conifer forests more than other habitat types.Implications: Our results highlight the importance of montane conifer to CNFS in the southern Appalachians. Management and restoration activities that increase the quality, connectivity and extent of this naturally rare forest type may be important for long-term conservation of this subspecies, especially with the impending threat of anthropogenic climate change.

Primary aldosteronism and thyroid disorders in atrial fibrillation: A Swedish nationwide case-control study.

PubMed

Mourtzinis, Georgios; Adamsson Eryd, Samuel; Rosengren, Annika; Björck, Lena; Adiels, Martin; Johannsson, Gudmundur; Manhem, Karin

2018-05-01

Background Atrial fibrillation is associated with hyperthyroidism. Patients with primary aldosteronism have an increased prevalence of atrial fibrillation. However, the prevalence of primary aldosteronism in the atrial fibrillation population is unknown. Aim This nationwide case-control study aimed to compare the prevalence of primary aldosteronism and thyroid disorders in patients with atrial fibrillation with that of age- and sex-matched controls. Methods We identified all atrial fibrillation cases in Sweden between 1987 and 2013 ( n = 713,569) by using the Swedish National Patient Register. A control cohort without atrial fibrillation was randomly selected from the Swedish Total Population Register with a case to control ratio of 1:2. This control cohort was matched for age, sex and place of birth ( n = 1,393,953). Results The prevalence of primary aldosteronism in December 2013 was 0.056% in the atrial fibrillation cohort and 0.024% in controls. At the same time, the prevalence of hypothyroidism was 5.9% in the atrial fibrillation cohort and 3.7% in controls. The prevalence of hyperthyroidism was 2.3% in the atrial fibrillation cohort and 0.8% in controls. Conclusion This study shows, for the first time, a doubled prevalence of primary aldosteronism in a large cohort of patients with atrial fibrillation compared with the general population. There is also an increased prevalence of hypo- and hyper-thyroidism in patients with atrial fibrillation compared with the general population.

Dental anomalies associated with unilateral and bilateral cleft lip and palate.

PubMed

Qureshi, Wafa A; Beiraghi, Soraya; Leon-Salazar, Vladimir

2012-01-01

The purpose of this study was to compare the prevalence of dental anomalies in the primary and permanent dentition of patients with unilateral (UCLP) and bilateral (BCLP) cleft lip with or without palate. One hundred two complete clinical records were randomly selected for review from a university-based cleft palate clinic. Only nonsyndromic UCLP and BCLP cases were further selected for analysis of dental anomalies. The prevalence of 9 dental categories, including anomalies in number, crown structure, position, and maxillary-mandibular relationship, was assessed and compared between UCLP and BCLP cases using Fisher's exact test. Of the 102 charts evaluated, there were 67 cases of UCLP and 29 cases of BCLP for a total of 96 cases. There was a high prevalence of dental anomalies in primary and permanent teeth; 93% of UCLP cases and 96% of BCLP cases presented with at least 1 dental anomaly. Significant differences ( P <.05) were only found in the prevalence of anodontia of a single tooth (UCLP=39%, BCLP=14%), multiple anodontia (UCLP=22%, BCLP=54%), and anterior malocclusion (UCLP=15%, BCLP=41%). There is a high prevalence of dental anomalies associated with orofacial clefts regardless of whether they are unilateral or bilateral cleft lip with or without palate.

Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

ERIC Educational Resources Information Center

Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

2013-01-01

Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

Implementing Group Medical Visits for Older Adults at Group Health Cooperative

PubMed Central

Levine, Martin D.; Ross, Tyler R.; Balderson, Benjamin H.K.; Phelan, Elizabeth A.

2010-01-01

In a pair of randomized controlled trials in Kaiser Colorado in the 1990s, Group Visits for older adults (monthly non disease-specific group medical appointments for a cohort of patients led by primary care teams) were proven to reduce costs, decrease hospitalizations, and improve patient and provider satisfaction. As part of a translational effort, this Group Visit intervention was replicated in a delivery system in Seattle, WA, and the log of total health care costs measured in the first year of the intervention. Utilization and patient and physician satisfaction were secondary outcomes. For the cost and utilization analysis, a retrospective case-control design compared 221 case patients 65 years of age and older with high outpatient utilization in the previous 18 months with 1,015 control patient selected randomly from clinics not participating in the intervention. Controls were matched to cases on the number of primary care visits in the prior 18 months. Total costs were not statistically different for intervention patients compared to controls ($8,845 vs. $10,288, p=0.11), nor were there statistically significant differences in utilization, including hospital admissions and outpatient visits. However, patient and provider satisfaction was high. This translational effort did not demonstrate the cost savings of the original efficacy trials. Possible explanations for these divergent results may have to do with differences in those who participated and differences between the two delivery systems. PMID:20002506

Young children's after-school activities - there's more to it than screen time: a cross-sectional study of young primary school children.

PubMed

Engelen, Lina; Bundy, Anita C; Bauman, Adrian; Naughton, Geraldine; Wyver, Shirley; Baur, Louise

2015-01-01

Children can spend substantial amounts of leisure time in sedentary activities, dominated by TV/screen time. However, objective real-time measurement of activities after school among young school children is seldom described. School children (n = 246, 5-7 years old, mean 6.0) and their parents were recruited by random selection from 14 schools across Sydney, Australia. Parents used a real-time objective measure (Experience Sampling Method, ESM) to record children's activities and whether they were indoors or outdoors at 3 random times each day after school. Data were collected across 4 weekdays in 1 week and then, 13 weeks later, another 4 weekdays in 1 week. Results were based on 2940 responses from 214 child-parent dyads showed that 25% of behavior involved physical activity, 51% was spent in sedentary activities, and 22% was TV/screen time. Most instances (81%) occurred indoors. Despite a high proportion of TV/screen time, children were also engaged in a range of other sedentary and physically active pursuits after school. Hence TV/screen time is not a suitable proxy for all sedentary behavior, and it is important to gather information on other non-screen-based sedentary and physically active behaviors. Future research is warranted to further investigate after-school activities in young primary school children.

Primary prevention of dental erosion by calcium and fluoride: a systematic review.

PubMed

Zini, A; Krivoroutski, Y; Vered, Y

2014-02-01

Overviews of the current literature only provide summaries of existing relevant preventive strategies for dental erosion. To perform a systematic review according to the quantitative meta-analysis method of the scientific literature on prevention of dental erosion. The focused question will address primary prevention of dental erosion by calcium and fluoride. Randomized clinical trials (RCTs) regarding dental erosion prevention. The search included five databases: Embase, Cochrane database of systematic reviews, PubMed (MEDLINE), FDA publication and Berman medical library of the Hebrew University. The search included data in the English language, with effect on preventing dental erosion always presented as mean enamel loss and measured by profilometer. Statistical meta-analysis was performed by StatsDirect program and PEPI statistical software. Fixed- and random-effect models were used to analyse the data. Heterogeneity tests were employed to validate the fixed-effect model assumption. A total of 475 articles on dental erosion prevention were located. A four-stage selection process was employed, and 10 RCT articles were found to be suitable for meta-analysis. The number of studies on prevention of dental erosion maintaining standards of evidence-based dentistry remains insufficient to reach any definite conclusions. The focused questions of this review cannot be addressed according to the existing literature. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis.

PubMed

Karyotaki, E; Kleiboer, A; Smit, F; Turner, D T; Pastor, A M; Andersson, G; Berger, T; Botella, C; Breton, J M; Carlbring, P; Christensen, H; de Graaf, E; Griffiths, K; Donker, T; Farrer, L; Huibers, M J H; Lenndin, J; Mackinnon, A; Meyer, B; Moritz, S; Riper, H; Spek, V; Vernmark, K; Cuijpers, P

2015-10-01

It is well known that web-based interventions can be effective treatments for depression. However, dropout rates in web-based interventions are typically high, especially in self-guided web-based interventions. Rigorous empirical evidence regarding factors influencing dropout in self-guided web-based interventions is lacking due to small study sample sizes. In this paper we examined predictors of dropout in an individual patient data meta-analysis to gain a better understanding of who may benefit from these interventions. A comprehensive literature search for all randomized controlled trials (RCTs) of psychotherapy for adults with depression from 2006 to January 2013 was conducted. Next, we approached authors to collect the primary data of the selected studies. Predictors of dropout, such as socio-demographic, clinical, and intervention characteristics were examined. Data from 2705 participants across ten RCTs of self-guided web-based interventions for depression were analysed. The multivariate analysis indicated that male gender [relative risk (RR) 1.08], lower educational level (primary education, RR 1.26) and co-morbid anxiety symptoms (RR 1.18) significantly increased the risk of dropping out, while for every additional 4 years of age, the risk of dropping out significantly decreased (RR 0.94). Dropout can be predicted by several variables and is not randomly distributed. This knowledge may inform tailoring of online self-help interventions to prevent dropout in identified groups at risk.

Effect of Fluoride Varnish on Streptococcus mutans Count in Saliva of Caries Free Children Using Dentocult SM Strip Mutans Test: A Randomized Controlled Triple Blind Study.

PubMed

A, Deepti; Jeevarathan, J; Muthu, Ms; Prabhu V, Rathna; Chamundeswari

2008-09-01

The aim of this study was to estimate the count of Streptococcus mutans in saliva of caries free children using Dentocult SM strip mutans and to evaluate the effect of fluoride varnish on the Streptococcus mutans count in saliva of these caries free children. Thirty caries free children were selected for the study based on the information obtained from a questionnaire prepared. They were randomly assigned into the control group and the study group consisting of ten and twenty children respectively. Samples of saliva were collected using the saliva strips from the Dentocult SM kit and after incubation the presence of the Streptococcus mutans was evaluated using the manufacturers' chart. The study group was subjected to Fluor Protector fluoride varnish application after 24 hours following which the samples were collected again. The average Streptococcus mutans count in primary dentition of caries free children was in the range of 10(4) to 10(5) colony forming units/ml. The average Streptococcus mutans count in primary dentition of caries free children after Fluor Protector fluoride varnish application was below 10(4) colony forming units/ml. Fluor Protector fluoride varnish application showed a statistically significant reduction in the Streptococcus mutans count in saliva of the caries free children in the study group.

Assessment of the relationship between perceptions of dental aesthetics and demand for orthodontic treatment in 10-11 year old school children in Birmingham, UK.

PubMed

Hamdan, A M; Singh, V; Rock, W P

2012-03-01

To examine the relationship between perceptions of dental aesthetics and demand for orthodontic treatment, and to determine whether the former can be used to predict the latter. A prospective cross sectional epidemiological survey of a random and representative sample of comprehensive primary schools in South Birmingham, UK. Participants were 389 randomly selected school children aged 10-11 years from 7 primary schools in South Birmingham. Their perceptions of dental aesthetics were determined using the Aesthetic Component (AC) of the Index of Orthodontic Treatment Need (IOTN). Demand for treatment was assessed by asking subjects if they wanted treatment with braces to correct their teeth. Only 2% of subjects assessed their dentition in the "definite need" for orthodontic treatment category. Demand for treatment was significantly greater in girls than boys (49% and 37% respectively, p < 0.05). Total demand (41%) was considerably greater than self assessed aesthetics in the "definite need" and "borderline need" categories combined (14%). Demand was accurately reflected in patients who perceived their dentition as having moderate to severe (AC 6-9) and very mild aesthetic impairment (AC 1). Perceptions of dental aesthetics using the AC of IOTN were able to predict demand for orthodontic treatment in patients with malocclusions of moderate to severe (AC 6-9) aesthetic impairment.

Randomization at the level of primary care practice: use of pre-intervention data and random effects models.

PubMed

Nixon, R M; Duffy, S W; Fender, G R; Day, N E; Prevost, T C

2001-06-30

The Anglia menorrhagia education study tests the effectiveness of an education package for the treatment of menorrhagia given to doctors at a primary care level. General practices were randomized to receive or not receive the package. It is hoped that this intervention will reduce the proportion of women suffering from menorrhagia that are referred to hospital. Data are available on the treatment and referral of women in the practices in the education and control groups, both pre- and post-intervention. We define and demonstrate a random effects logistic regression model that includes pre-intervention data for calculating the effectiveness of the intervention. Copyright 2001 John Wiley & Sons, Ltd.

What do we know about the effects of exposure to 'Low alcohol' and equivalent product labelling on the amounts of alcohol, food and tobacco people select and consume? A systematic review.

PubMed

Shemilt, Ian; Hendry, Vivien; Marteau, Theresa M

2017-01-12

Explicit labelling of lower strength alcohol products could reduce alcohol consumption by attracting more people to buy and drink such products instead of higher strength ones. Alternatively, it may lead to more consumption due to a 'self-licensing' mechanism. Equivalent labelling of food or tobacco (for example "Low fat" or "Low tar") could influence consumption of those products by similar mechanisms. This systematic review examined the effects of 'Low alcohol' and equivalent labelling of alcohol, food and tobacco products on selection, consumption, and perceptions of products among adults. A systematic review was conducted based on Cochrane methods. Electronic and snowball searches identified 26 eligible studies. Evidence from 12 randomised controlled trials (all on food) was assessed for risk of bias, synthesised using random effects meta-analysis, and interpreted in conjunction with evidence from 14 non-randomised studies (one on alcohol, seven on food and six on tobacco). Outcomes assessed were: quantities of the product (i) selected or (ii) consumed (primary outcomes - behaviours), (iii) intentions to select or consume the product, (iv) beliefs associated with it consumption, (v) product appeal, and (vi) understanding of the label (secondary outcomes - cognitions). Evidence for impacts on the primary outcomes (i.e. amounts selected or consumed) was overall of very low quality, showing mixed effects, likely to vary by specific label descriptors, products and population characteristics. Overall very low quality evidence suggested that exposure to 'Low alcohol' and equivalent labelling on alcohol, food and tobacco products can shift consumer perceptions of products, with the potential to 'self-licence' excess consumption. Considerable uncertainty remains about the effects of labels denoting low alcohol, and equivalent labels, on alcohol, food and tobacco selection and consumption. Independent, high-quality studies are urgently needed to inform policies on labelling regulations.

Access to water and sanitation facilities in primary schools: A neglected educational crisis in Ngamiland district in Botswana

NASA Astrophysics Data System (ADS)

Ngwenya, B. N.; Thakadu, O. T.; Phaladze, N. A.; Bolaane, B.

2018-06-01

In developing countries, the sanitation and hygiene provision often receives limited resources compared to the water supply. However, water supply benefits tend to diminish if improved sanitation and hygiene are neglected. This paper presents findings of a situational analysis of water supply, sanitation and hygiene infrastructure and their utilization in three primary schools in north-western Botswana. The overall objective of the paper is to determine access and functionality of water supply, sanitation and hygiene infrastructure in three primary schools. The specific objectives are: a) Learners' perspective of their water and sanitation facilities and b) gendered utilization of sanitation and hygiene facilities. Data were collected through a face-to-face administered social survey tool to 286 learners selected through proportionate stratified random sampling from three purposively selected villages in the middle and lower Okavango Delta. Findings indicate that standpipes provide 96% of potable water supply. However, the majority (65% of leaners) indicated that they 'sometimes' experienced water shortage due to dry/nonfunctioning taps/pumps and leaks/wastage. Overall, schools have relatively sufficient sanitation facilities consisting of both water borne toilets and VIP latrines. The major sanitation gap identified was that 80% flush toilets hardly work, while 77% of VIP toilets were in disrepair. Furthermore, poor water supply compromised hand washing with 65.7% learners "always" washing their hands if school standpipes had water, while the majority did not wash hands if standpipes were dry. The study concluded that availability of sanitation infrastructure does not necessarily translate into utilization in the study area due to multiple problems, such as lack of personal hygiene supplies (regular toilet paper and hand washing detergents), privacy issues and recurring water problems. The chronicity of inadequate water, sanitation and hygiene infrastructure in primary schools is critical and there is urgent need to address these challenges in order to create a conducive learning environment in primary schools in the district.

Primary venous insufficiency increases risk of deep vein thrombosis.

PubMed

Shaydakov, Maxim E; Comerota, Anthony J; Lurie, Fedor

2016-04-01

Varicose veins have been recognized as a risk factor for deep vein thrombosis (DVT). However, venous reflux has not carried the same correlation. This study evaluated the association between primary valvular reflux and DVT. We performed a nested case-control study with enrollment of outpatients presenting to the vascular laboratory with signs and symptoms of DVT. All patients had a complete bilateral venous duplex examination evaluating for DVT and superficial and deep venous valvular reflux. Eighty-seven patients with confirmed DVT on venous duplex were selected for the study group. The control group was randomly selected from the same cohort in a 4:1 ratio matched by age and gender (n = 348). Groups were compared for the prevalence of deep and superficial reflux. DVT outpatients were 4.7-times more likely to have primary valvular reflux than symptomatic controls (65.5% vs 29.0%; 95% confidence interval [CI], 2.8-7.7; P < .000001). Deep reflux was 2.1-times more prevalent (36.8% vs 21.6%; odds ratio, 2.12; 95% CI, 1.28-3.51; P = .005) and superficial reflux was 4.6-times more prevalent (43.7% vs 14.4%; odds ratio, 4.62; 95% CI, 2.75-7.77; P < .0000001) in DVT patients than in controls. DVT patients were also 2.1-times more likely to have combined deep and superficial reflux than non-DVT patients (13.8% vs 6.6%, 95% CI, 1.08-4.75; P = .044). The prevalence of primary valvular reflux in patients with DVT is significantly higher than expected. Reflux may be considered as a novel risk factor for DVT. Two-thirds of patients with DVT have pre-existent primary chronic venous disease, which is likely to contribute to post-thrombotic morbidity. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

School-located Influenza Vaccinations for Adolescents: A Randomized Controlled Trial.

PubMed

Szilagyi, Peter G; Schaffer, Stanley; Rand, Cynthia M; Goldstein, Nicolas P N; Vincelli, Phyllis; Hightower, A Dirk; Younge, Mary; Eagan, Ashley; Blumkin, Aaron; Albertin, Christina S; DiBitetto, Kristine; Yoo, Byung-Kwang; Humiston, Sharon G

2018-02-01

We aimed to evaluate the effect of school-located influenza vaccination (SLIV) on adolescents' influenza vaccination rates. In 2015-2016, we performed a cluster-randomized trial of adolescent SLIV in middle/high schools. We selected 10 pairs of schools (identical grades within pairs) and randomly allocated schools within pairs to SLIV or usual care control. At eight suburban SLIV schools, we sent parents e-mail notifications about upcoming SLIV clinics and promoted online immunization consent. At two urban SLIV schools, we sent parents (via student backpack fliers) paper immunization consent forms and information about SLIV. E-mails were unavailable at these schools. Local health department nurses administered nasal or injectable influenza vaccine at dedicated SLIV clinics and billed insurers. We compared influenza vaccination rates at SLIV versus control schools using school directories to identify the student sample in each school. We used the state immunization registry to determine receipt of influenza vaccination. The final sample comprised 17,650 students enrolled in the 20 schools. Adolescents at suburban SLIV schools had higher overall influenza vaccination rates than did adolescents at control schools (51% vs. 46%, p < .001; adjusted odds ratio = 1.27, 95% confidence interval 1.18-1.38, controlling for vaccination during the prior two seasons). No effect of SLIV was noted among urbanschools on multivariate analysis. SLIV did not substitute for vaccinations in primary care or other settings; in suburban settings, SLIV was associated with increased vaccinations in primary care or other settings (adjusted odds ratio = 1.10, 95% confidence interval 1.02-1.19). SLIV in this community increased influenza vaccination rates among adolescents attending suburban schools. Copyright © 2018. Published by Elsevier Inc.

Re-starting smoking in the postpartum period after receiving a smoking cessation intervention: a systematic review.

PubMed

Jones, Matthew; Lewis, Sarah; Parrott, Steve; Wormall, Stephen; Coleman, Tim

2016-06-01

In pregnant smoking cessation trial participants, to estimate (1) among women abstinent at the end of pregnancy, the proportion who re-start smoking at time-points afterwards (primary analysis) and (2) among all trial participants, the proportion smoking at the end of pregnancy and at selected time-points during the postpartum period (secondary analysis). Trials identified from two Cochrane reviews plus searches of Medline and EMBASE. Twenty-seven trials were included. The included trials were randomized or quasi-randomized trials of within-pregnancy cessation interventions given to smokers who reported abstinence both at end of pregnancy and at one or more defined time-points after birth. Outcomes were validated biochemically and self-reported continuous abstinence from smoking and 7-day point prevalence abstinence. The primary random-effects meta-analysis used longitudinal data to estimate mean pooled proportions of re-starting smoking; a secondary analysis used cross-sectional data to estimate the mean proportions smoking at different postpartum time-points. Subgroup analyses were performed on biochemically validated abstinence. The pooled mean proportion re-starting at 6 months postpartum was 43% [95% confidence interval (CI) = 16-72%, I(2)  = 96.7%] (11 trials, 571 abstinent women). The pooled mean proportion smoking at the end of pregnancy was 87% (95% CI = 84-90%, I(2)  = 93.2%) and 94% (95% CI = 92-96%, I(2)  = 88%) at 6 months postpartum (23 trials, 9262 trial participants). Findings were similar when using biochemically validated abstinence. In clinical trials of smoking cessation interventions during pregnancy only 13% are abstinent at term. Of these, 43% re-start by 6 months postpartum. © 2016 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Clinical and microbiological effectiveness of photodynamic therapy on primary endodontic infections: a 6-month randomized clinical trial.

PubMed

de Miranda, Rachel Garcia; Colombo, Ana Paula Vieira

2018-05-01

This short-term randomized controlled trial evaluated the effectiveness of photodynamic therapy (PDT) on clinical success (periapical healing) and on the microbiota of primary endodontic infections. Thirty-two patients presenting mandibular molars with apical periodontitis (one tooth/patient) were selected and randomly allocated into two therapeutic groups: control (chemo-mechanical debridement [CMD]; n = 16) and PDT (CMD + PDT; n = 16). All teeth in both groups had intracanal medication with calcium hydroxide for 7 days before final obturation. Follow-up radiographs were made at 3 and 6 months. Periapical healing was evaluated by the periapical index (PAI). Samples were obtained at baseline, after CMD with or without PDT, and just before root filling to determine the frequency and levels of 37 taxa by checkerboard. Significant decreases in PAI scores were observed in both groups over time, although at 6 months, the PDT group presented a significantly better healing score than the control (p < 0.05). At baseline, the most prevalent species in all samples were Candida albicans (46.9%), Dialister pneumosintes (31.2%), Prevotella nigrescens (28.2%), Prevotella tannerae (28.1%), and Peptostreptococcus anaerobius (25%). Most species reduced over time in both groups, and no significant differences in frequency and levels of the tested species were observed between groups in any time point evaluated. C. albicans and D. pneumosintes were still detected in high frequency in both groups at 3 months post-therapy. Conventional endodontic therapy with or without PDT is effective in reducing microbial load, resulting in periapical healing. Nevertheless, adjunctive PDT provides better periapical healing at 6-month follow-up. Teeth with apical periodontitis treated with PDT adjunct to conventional treatment would demonstrate superior healing and reduction of microorganisms.

Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

PubMed

Min, Jie; Li, Xiao-qiang; She, Bin; Chen, Yan; Mao, Bing

2015-05-19

Although the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS). This is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score. This trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial. The registration number is ChiCTR-TRC-14004255 , which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.

Treatment of hypothyroidism with levothyroxine plus liothyronine: a randomized, double-blind, crossover study.

PubMed

Kaminski, Juliana; Miasaki, Fabíola Yukiko; Paz-Filho, Gilberto; Graf, Hans; Carvalho, Gisah Amaral de

2016-01-01

To compare the effects of a unique fixed combination levothyroxine/liothyronine (LT4/LT3) therapy in patients with primary hypothyroidism. This is a randomized, double-blind, crossover study. Adults with primary hypothyroidism (n = 32, age 42.6 ± 13.3, 30 females) on stable doses of LT4 for ≥ 6 months (125 or 150 μg/day) were randomized to continue LT4 treatment (G1) or to start LT4/LT3 therapy (75/15 μg/day; G2). After 8 weeks, participants switched treatments for 8 more weeks. Thyroid function, lipid profile, plasma glucose, body weight, electrocardiogram, vital signs, and quality of life (QoL) were evaluated at weeks 0, 8 and 16. Free T4 levels were significantly lower while on LT4/LT3 (G1: 1.07 ± 0.29 vs. 1.65 ± 0.46; G2: 0.97 ± 0.26 vs. 1.63 ± 0.43 ng/dL; P < 0.001). TSH and T3 levels were not affected by type of therapy. More patients on LT4/LT3 had T3 levels above the upper limit (15% vs. 3%). The combination therapy led to an increase in heart rate, with no significant changes in electrocardiogram or arterial blood pressure. Lipid profile, body weight and QoL remained unchanged. The combination therapy yielded significantly lower free T4 levels, with no changes in TSH or T3 levels. More patients on LT4/T3 had elevated T3 levels, with no significant alterations in the evaluated outcomes. No clear clinical benefit of the studied formulation could be observed. Future trials need to evaluate different formulations and the impact of the combined therapy in select populations with genetic polymorphisms.

Clinical, metabolic and psychological outcomes and treatment costs of a prospective randomized trial based on different educational strategies to improve diabetes care (PRODIACOR).

PubMed

Gagliardino, J J; Lapertosa, S; Pfirter, G; Villagra, M; Caporale, J E; Gonzalez, C D; Elgart, J; González, L; Cernadas, C; Rucci, E; Clark, C

2013-09-01

To evaluate the effect of system interventions (formalized data collection and 100% coverage of medications and supplies) combined with physician and/or patient education on therapeutic indicators and costs in Type 2 diabetes. This was a randomized 2 × 2 design in public health, social security or private prepaid primary care clinics in Corrientes, Argentina. Thirty-six general practitioners and 468 adults with Type 2 diabetes participated. Patients of nine participating physicians were selected randomly and assigned to one of four structured group education programmes (117 patients each): control (group 1), physician education (group 2), patient education (group 3), and both physician education and patient education (group 4), with identical system interventions in all four groups. Outcome measures included HbA(1c), BMI, blood pressure, fasting glucose, lipid profile, drug consumption, resource use and patient well-being at baseline and every 6 months up to 42 months. HbA(1c) decreased significantly from 4 mmol/mol to 10 mmol/mol by 42 months (P < 0.05); the largest and more consistent decrease was in the groups where patients and physicians were educated. Blood pressure and triglycerides decreased significantly in all groups; the largest changes were recorded in the combined education group. The World Health Organization-5 Lowe score showed significant improvements, without differences among groups. The lowest treatment cost was seen in the combined education group. In a primary care setting, educational interventions combined with comprehensive care coverage resulted in long-term improvement in clinical, metabolic and psychological outcomes at the best cost-effectiveness ratio. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

A Content Analysis of E-mail Communication between Patients and Their Providers: Patients Get the Message

PubMed Central

White, Casey B.; Moyer, Cheryl A.; Stern, David T.; Katz, Steven J.

2004-01-01

Objective: E-mail use in the clinical setting has been slow to diffuse for several reasons, including providers' concerns about patients' inappropriate and inefficient use of the technology. This study examined the content of a random sample of patient–physician e-mail messages to determine the validity of those concerns. Design: A qualitative analysis of patient–physician e-mail messages was performed. Measurements: A total of 3,007 patient–physician e-mail messages were collected over 11 months as part of a randomized, controlled trial of a triage-based e-mail system in two primary care centers (including 98 physicians); 10% of messages were randomly selected for review. Messages were coded across such domains as message type, number of requests per e-mail, inclusion of sensitive content, necessity of a physician response, and message tone. Results: The majority (82.8%) of messages addressed a single issue. The most common message types included information updates to the physicians (41.4%), prescription renewals (24.2%), health questions (13.2%), questions about test results (10.9%), referrals (8.8%), “other” (including thank yous, apologies) (8.8%), appointments (5.4%), requests for non-health-related information (4.8%), and billing questions (0.3%). Overall, messages were concise, formal, and medically relevant. Very few (5.1%) included sensitive content, and none included urgent messages. Less than half (43.2%) required a physician response. Conclusion: A triage-based e-mail system promoted e-mail exchanges appropriate for primary care. Most patients adhered to guidelines aimed at focusing content, limiting the number of requests per message, and avoiding urgent requests or highly sensitive content. Thus, physicians' concerns about the content of patients' e-mails may be unwarranted. PMID:15064295

Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

PubMed

Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

2013-01-01

Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

Stress reduction in the secondary prevention of cardiovascular disease: randomized, controlled trial of transcendental meditation and health education in Blacks.

PubMed

Schneider, Robert H; Grim, Clarence E; Rainforth, Maxwell V; Kotchen, Theodore; Nidich, Sanford I; Gaylord-King, Carolyn; Salerno, John W; Kotchen, Jane Morley; Alexander, Charles N

2012-11-01

Blacks have disproportionately high rates of cardiovascular disease. Psychosocial stress may contribute to this disparity. Previous trials on stress reduction with the Transcendental Meditation (TM) program have reported improvements in cardiovascular disease risk factors, surrogate end points, and mortality in blacks and other populations. This was a randomized, controlled trial of 201 black men and women with coronary heart disease who were randomized to the TM program or health education. The primary end point was the composite of all-cause mortality, myocardial infarction, or stroke. Secondary end points included the composite of cardiovascular mortality, revascularizations, and cardiovascular hospitalizations; blood pressure; psychosocial stress factors; and lifestyle behaviors. During an average follow-up of 5.4 years, there was a 48% risk reduction in the primary end point in the TM group (hazard ratio, 0.52; 95% confidence interval, 0.29-0.92; P=0.025). The TM group also showed a 24% risk reduction in the secondary end point (hazard ratio, 0.76; 95% confidence interval, 0.51-0.1.13; P=0.17). There were reductions of 4.9 mmHg in systolic blood pressure (95% confidence interval -8.3 to -1.5 mmHg; P=0.01) and anger expression (P<0.05 for all scales). Adherence was associated with survival. A selected mind-body intervention, the TM program, significantly reduced risk for mortality, myocardial infarction, and stroke in coronary heart disease patients. These changes were associated with lower blood pressure and psychosocial stress factors. Therefore, this practice may be clinically useful in the secondary prevention of cardiovascular disease. Clinical Trial Registration- URL: www.clinicaltrials.gov Unique identifier: NCT01299935.

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial.

PubMed

Hustedt, John; Doum, Dyna; Keo, Vanney; Ly, Sokha; Sam, BunLeng; Chan, Vibol; Alexander, Neal; Bradley, John; Prasetyo, Didot Budi; Rachmat, Agus; Muhammad, Shafique; Lopes, Sergio; Leang, Rithea; Hii, Jeffrey

2017-08-04

Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia. In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control). Households will be invited to participate, and entomology surveys among 40 randomly selected households per cluster will be carried out quarterly. The primary outcome will be the population density of adult female Aedes mosquitoes (i.e., number per house) trapped using adult resting collections. Secondary outcome measures will include the House Index, Container Index, Breteau Index, Pupae Per House, Pupae Per Person, mosquito infection rate, guppy fish coverage, Sumilarv® 2MR coverage, and percentage of respondents with knowledge about Aedes mosquitoes causing dengue. In the primary analysis, adult female Aedes density and mosquito infection rates will be aggregated over follow-up time points to give a single rate per cluster. This will be analyzed by negative binomial regression, yielding density ratios. This trial is expected to provide robust estimates of the intervention effect. A rigorous evaluation of these vector-control interventions is vital to developing an evidence-based dengue control strategy and to help direct government resources. Current Controlled Trials, ID: ISRCTN85307778 . Registered on 25 October 2015.

Treatment of post-myocardial infarction depressive disorder: a randomized, placebo-controlled trial with mirtazapine.

PubMed

Honig, Adriaan; Kuyper, Astrid M G; Schene, Aart H; van Melle, Joost P; de Jonge, Peter; Tulner, Dorien M; Schins, Annique; Crijns, Harry J G M; Kuijpers, Petra M J C; Vossen, Helen; Lousberg, Richel; Ormel, Johan

2007-01-01

To examine the antidepressant efficacy of a dual-acting antidepressant (mirtazapine) in patients with post-myocardial infarction (MI) depressive disorder. Antidepressants used in post MI trials with a randomized, double-blind, placebo-controlled design have been restricted to selective serotonin reuptake inhibitors (SSRIs). Antidepressant effects have been limited. In a prospective multicenter study, 2177 patients with MI were evaluated for depressive disorder during the first year post MI. Ninety-one patients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major or minor depressive disorder were randomized to a 24-week, double-blind, placebo-controlled trial. Antidepressant efficacy was tested using last-observation-carried-forward procedure and repeated measurements analysis using the SPPS mixed models approach, with as primary outcome reduction in depressive symptomatology on the 17-item Hamilton-Depression Rating Scale (Ham-D), and secondary outcomes the Beck Depression Inventory (BDI) and depression subscale of the Symptom Check List 90 items (dSCL-90) as well as the Clinical Global Impression (CGI) scale. Using the "last observation carried forward" (LOCF) method, mirtazapine did not show to be superior to placebo on the Ham-D, but did on the BDI, dSCL-90, and CGI scale over the acute treatment phase of 8 weeks (n = 91). Using mixed models analysis over the entire 24 weeks of treatment (n = 40), we did find a significant difference favoring mirtazapine to placebo on the Ham-D, BDI, and CGI, but on the dSCL-90, this difference was not significant. This trial shows efficacy of mirtazapine on primary and secondary depression measures. Mirtazapine seems to be safe in the treatment of post-MI depression.

Clinical benefit of drugs targeting mitochondrial function as an adjunct to reperfusion in ST-segment elevation myocardial infarction: A meta-analysis of randomized clinical trials.

PubMed

Campo, Gianluca; Pavasini, Rita; Morciano, Giampaolo; Lincoff, A Michael; Gibson, C Michael; Kitakaze, Masafumi; Lonborg, Jacob; Ahluwalia, Amrita; Ishii, Hideki; Frenneaux, Michael; Ovize, Michel; Galvani, Marcello; Atar, Dan; Ibanez, Borja; Cerisano, Giampaolo; Biscaglia, Simone; Neil, Brandon J; Asakura, Masanori; Engstrom, Thomas; Jones, Daniel A; Dawson, Dana; Ferrari, Roberto; Pinton, Paolo; Ottani, Filippo

2017-10-01

To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. Inclusion criteria: RCTs enrolling STEMI patients treated with primary percutaneous coronary intervention (PCI) and comparing drugs targeting mitochondrial function vs. placebo. Odds ratios (OR) were computed from individual studies and pooled with random-effect meta-analysis. Fifteen studies were identified involving 5680 patients. When compared with placebo, drugs targeting mitochondrial component/pathway were not associated with significant reduction of cardiovascular and all-cause mortality (OR 0.9, 95% CI 0.7-1.17 and OR 0.92, 95% CI 0.69-1.23, respectively). However, these agents significantly reduced hospital admission for heart failure (HF) (OR 0.64; 95% CI 0.45-0.92) and increased left ventricular ejection fraction (LVEF) (OR 1.44; 95% CI 1.15-1.82). After analysis for subgroups according to the mechanism of action, drugs with direct/selective action did not reduce any outcome. Conversely, those with indirect/unspecific action showed a significant effect on cardiovascular mortality (0.65, 95% CI 0.46-0.92), all-cause mortality (OR 0.69, 95% CI 0.52-0.92), hospital readmission for HF (OR 0.41, 95% CI 0.28-0.6) and LVEF (OR 1.49, 95% CI 1.09-2.05). Administration of drugs targeting mitochondrial function in STEMI patients undergoing primary PCI appear to have no effect on mortality, but may reduce hospital readmission for HF. The drugs with a broad-spectrum mechanism of action seem to be more effective in reducing adverse events. Copyright © 2017 Elsevier B.V. All rights reserved.

S-1 versus S-1 plus cisplatin concurrent intensity modulated radiation therapy in the treatment of esophageal squamous cell carcinoma: Study protocol for a randomized controlled phase II trial.

PubMed

Wen, Yixue; Zhao, Zhenhuan; Miao, Jidong; Yang, Qilin; Gui, Yan; Sun, Mingqiang; Tian, Honggang; Jia, Qiang; Liao, Dongbiao; Yang, Chen; Du, Xiaobo

2017-12-01

Chemotherapy regimens are often a 2-drug regimen in concurrent chemotherapy and radiotherapy for esophageal cancer (EC). However, some retrospective studies have suggested that for patients with EC receiving radiotherapy combined with 2-drug chemotherapy have the severe toxicity. And S-1 alone with the combination of radiotherapy treatment effect is good, and achieved good clinical remission rate. The purpose of this trial is compare the efficacy and toxicity of combining S-1 or S-1 plus cisplatin with radiotherapy for esophageal squamous cell carcinoma. The study is a randomized, controlled, multicenter trial, comparing S-1 versus S-1 plus cisplatin concurrent radiotherapy for patients with esophageal squamous cell carcinoma. Eighty-eight patients with unresectable or medically unfit for surgery esophageal squamous cell carcinoma (clinical stage I to III), will randomly assigned to receive four cycles (2 concomitant and 2 postradiotherapy) S-1 or S-1 plus cisplatin along with radiotherapy 60-66 Gy/30 to 33 fractions. The primary outcome is complete response rate of primary tumor which will be measured by endoscopy and computer screen at 3 months after the completion of treatment. Secondary outcomes include survival and toxicity. To our knowledge, this study protocol is the first to test the effect between S-1 versus S-1 plus cisplatin concurrent intensity modulated radiation therapy in the treatment of esophageal squamous cell carcinoma. If the result will be the same effect and fewer side effects and less costly in S-1 plus radiotherapy. It will supply more treatment selection for esophageal squamous cell carcinoma.

Exercise Training and Recreational Activities to Promote Executive Functions in Chronic Stroke: A Proof-of-Concept Study

PubMed Central

Liu-Ambrose, Teresa; Eng, Janice J

2015-01-01

Background Stroke survivors represent a target population in need of intervention strategies to promote cognitive function and prevent dementia. Both exercise and recreational activities are promising strategies. We assessed the effect of a six-month exercise and recreation program on executive functions in adults with chronic stroke. Methods A six-month ancillary study within a multi-centre randomized trial. Twenty-eight chronic stroke survivors (i.e., ≥ 12 months since an index stroke) were randomized to one of two experimental groups: intervention (INT; n=12) or delayed intervention (D-INT; n=16). Participants of the INT group received a six-month community-based structured program that included two sessions of exercise training and one session of recreation and leisure activities per week. Participants of the D-INT group received usual care. The primary outcome measure was the Stroop Test, a cognitive test of selective attention and conflict resolution. Secondary cognitive measures included set shifting and working memory. Mood, functional capacity, and general balance and mobility were additional secondary outcome measures. Results Compared with the D-INT group, the INT group significantly improved selective attention and conflict resolution (p=0.02), working memory (p=0.04), and functional capacity (p=0.02) at the end of the six-month intervention period. Improved selective attention and conflict resolution was significantly associated with functional capacity at six months (r=0.39; p=0.04). Conclusions This is the first randomized study to demonstrate that an exercise and recreation program can significantly benefit executive functions in community-dwelling chronic stroke survivors who are mildly cognitively impaired – a population at high-risk for dementia and functional decline. Thus, clinicians should consider prescribing exercise and recreational activities in the cognitive rehabilitation of chronic stroke survivors. Clinical Trial Registration http://clinicaltrials.gov. Unique identifier: NCT01085240. PMID:25440324

Automatic learning-based beam angle selection for thoracic IMRT

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

Amit, Guy; Marshall, Andrea; Purdie, Thomas G., E-mail: tom.purdie@rmp.uhn.ca

Purpose: The treatment of thoracic cancer using external beam radiation requires an optimal selection of the radiation beam directions to ensure effective coverage of the target volume and to avoid unnecessary treatment of normal healthy tissues. Intensity modulated radiation therapy (IMRT) planning is a lengthy process, which requires the planner to iterate between choosing beam angles, specifying dose–volume objectives and executing IMRT optimization. In thorax treatment planning, where there are no class solutions for beam placement, beam angle selection is performed manually, based on the planner’s clinical experience. The purpose of this work is to propose and study a computationallymore » efficient framework that utilizes machine learning to automatically select treatment beam angles. Such a framework may be helpful for reducing the overall planning workload. Methods: The authors introduce an automated beam selection method, based on learning the relationships between beam angles and anatomical features. Using a large set of clinically approved IMRT plans, a random forest regression algorithm is trained to map a multitude of anatomical features into an individual beam score. An optimization scheme is then built to select and adjust the beam angles, considering the learned interbeam dependencies. The validity and quality of the automatically selected beams evaluated using the manually selected beams from the corresponding clinical plans as the ground truth. Results: The analysis included 149 clinically approved thoracic IMRT plans. For a randomly selected test subset of 27 plans, IMRT plans were generated using automatically selected beams and compared to the clinical plans. The comparison of the predicted and the clinical beam angles demonstrated a good average correspondence between the two (angular distance 16.8° ± 10°, correlation 0.75 ± 0.2). The dose distributions of the semiautomatic and clinical plans were equivalent in terms of primary target volume coverage and organ at risk sparing and were superior over plans produced with fixed sets of common beam angles. The great majority of the automatic plans (93%) were approved as clinically acceptable by three radiation therapy specialists. Conclusions: The results demonstrated the feasibility of utilizing a learning-based approach for automatic selection of beam angles in thoracic IMRT planning. The proposed method may assist in reducing the manual planning workload, while sustaining plan quality.« less

Chromium picolinate reduces insulin resistance in polycystic ovary syndrome: Randomized controlled trial.

PubMed

Ashoush, Sherif; Abou-Gamrah, Amgad; Bayoumy, Hassan; Othman, Noura

2016-03-01

To investigate the effect of chromium picolinate (CrP) on insulin resistance (IR) in polycystic ovary syndrome (PCOS). This double blinded randomized controlled trial was conducted in the Gynecology outpatient clinics at Ain Shams University Women's Hospital. Using closed and randomly mixed envelopes, 100 women were selected out of 400 PCOS patients. Eighty-five patients finished the study and were analyzed, 44 in group I and 41 in group II. They were randomly allocated to 6 months of either 1000 μg CrP (50 patients), or placebo capsules (50 patients). Patients were seen monthly to encourage similar diet control and physical exercise plans. The primary outcome was fasting glucose insulin ratio (FGIR), secondary outcomes included ovulation, regularity of the cycle, body mass index (BMI), fasting blood sugar (FBS), fasting serum insulin (FSI), and serum testosterone level. There were no significant differences between women of both groups regarding pretreatment levels of FBS, FSI, FGIR, and serum testosterone. Use of CrP for 6 months was associated with significant reduction of BMI (P < 0.001) and FSI (P = 0.007), and significant rise in FGIR (P = 0.045). CrP significantly increased the chances of ovulation (P = 0.011) and regular menstruation (P = 0.002) by almost twofold after the fifth month of treatment. Chromium picolinate is useful in PCOS to reduce IR and stimulate ovulation. © 2015 Japan Society of Obstetrics and Gynecology.

Meta-analysis of randomized trials on access site selection for percutaneous coronary intervention in ST-segment elevation myocardial infarction

PubMed Central

Komócsi, András; Aradi, Dániel; Kehl, Dániel; Ungi, Imre; Thury, Attila; Pintér, Tünde; Di Nicolantonio, James J.; Tornyos, Adrienn

2014-01-01

Introduction Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI. Material and methods Electronic databases were searched for relevant studies from January 1993 to November 2012. Outcome parameters of RCTs were pooled with the DerSimonian-Laird random-effects model. Results Twelve RCTs involving 5,124 patients were identified. According to the pooled analysis, TRPCI was associated with a significant reduction in major bleeding (odds ratio (OR): 0.52 (95% confidence interval (CI) 0.38–0.71, p < 0.0001)). The risk of mortality and major adverse events was significantly lower after TRPCI (OR = 0.58 (95% CI: 0.43–0.79), p = 0.0005 and OR = 0.67 (95% CI: 0.52–0.86), p = 0.002 respectively). Conclusions Robust data from randomized clinical studies indicate that TRPCI reduces both ischemic and bleeding complications in STEMI. These findings support the preferential use of radial access for primary PCI. PMID:24904651

Meta-analysis of randomized trials on access site selection for percutaneous coronary intervention in ST-segment elevation myocardial infarction.

PubMed

Komócsi, András; Aradi, Dániel; Kehl, Dániel; Ungi, Imre; Thury, Attila; Pintér, Tünde; Di Nicolantonio, James J; Tornyos, Adrienn; Vorobcsuk, András

2014-05-12

Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI. Electronic databases were searched for relevant studies from January 1993 to November 2012. Outcome parameters of RCTs were pooled with the DerSimonian-Laird random-effects model. Twelve RCTs involving 5,124 patients were identified. According to the pooled analysis, TRPCI was associated with a significant reduction in major bleeding (odds ratio (OR): 0.52 (95% confidence interval (CI) 0.38-0.71, p < 0.0001)). The risk of mortality and major adverse events was significantly lower after TRPCI (OR = 0.58 (95% CI: 0.43-0.79), p = 0.0005 and OR = 0.67 (95% CI: 0.52-0.86), p = 0.002 respectively). Robust data from randomized clinical studies indicate that TRPCI reduces both ischemic and bleeding complications in STEMI. These findings support the preferential use of radial access for primary PCI.

Patient navigation and financial incentives to promote smoking cessation in an underserved primary care population: A randomized controlled trial protocol.

PubMed

Quintiliani, Lisa M; Russinova, Zlatka L; Bloch, Philippe P; Truong, Ve; Xuan, Ziming; Pbert, Lori; Lasser, Karen E

2015-11-01

Despite the high risk of tobacco-related morbidity and mortality among low-income persons, few studies have connected low-income smokers to evidence-based treatments. We will examine a smoking cessation intervention integrated into primary care. To begin, we completed qualitative formative research to refine an intervention utilizing the services of a patient navigator trained to promote smoking cessation. Next, we will conduct a randomized controlled trial combining two interventions: patient navigation and financial incentives. The goal of the intervention is to promote smoking cessation among patients who receive primary care in a large urban safety-net hospital. Our intervention will encourage patients to utilize existing smoking cessation resources (e.g., quit lines, smoking cessation groups, discussing smoking cessation with their primary care providers). To test our intervention, we will conduct a randomized controlled trial, randomizing 352 patients to the intervention condition (patient navigation and financial incentives) or an enhanced traditional care control condition. We will perform follow-up at 6, 12, and 18 months following the start of the intervention. Evaluation of the intervention will target several implementation variables: reach (participation rate and representativeness), effectiveness (smoking cessation at 12 months [primary outcome]), unintended consequences (e.g., purchase of illicit substances with incentive money), adoption (use of intervention across primary care suites), implementation (delivery of intervention), and maintenance (smoking cessation after conclusion of intervention). Improving the implementation of smoking cessation interventions in primary care settings serving large underserved populations could have substantial public health impact, reducing cancer-related morbidity/mortality and associated health disparities. Copyright © 2015 Elsevier Inc. All rights reserved.

Moving a randomized clinical trial into an observational cohort.

PubMed

Goodman, Phyllis J; Hartline, Jo Ann; Tangen, Catherine M; Crowley, John J; Minasian, Lori M; Klein, Eric A; Cook, Elise D; Darke, Amy K; Arnold, Kathryn B; Anderson, Karen; Yee, Monica; Meyskens, Frank L; Baker, Laurence H

2013-02-01

The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled prostate cancer prevention study funded by the National Cancer Institute (NCI) and conducted by the Southwest Oncology Group (SWOG). A total of 35,533 men were assigned randomly to one of the four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, and placebo + placebo). The independent Data and Safety Monitoring Committee (DSMC) recommended the discontinuation of study supplements because of the lack of efficacy for risk reduction and because futility analyses demonstrated no possibility of benefit of the supplements to the anticipated degree (25% reduction in prostate cancer incidence) with additional follow-up. Study leadership agreed that the randomized trial should be terminated but believed that the cohort should be maintained and followed as the additional follow-up would contribute important information to the understanding of the biologic consequences of the intervention. Since the participants no longer needed to be seen in person to assess acute toxicities or to be given study supplements, it was determined that the most efficient and cost-effective way to follow them was via a central coordinated effort. A number of changes were necessary at the local Study Sites and SELECT Statistical Center to transition to following participants via a Central Coordinating Center. We describe the transition process from a randomized clinical trial to the observational Centralized Follow-Up (CFU) study. The process of transitioning SELECT, implemented at more than 400 Study Sites across the United States, Canada, and Puerto Rico, entailed many critical decisions and actions including updates to online documents such as the SELECT Workbench and Study Manual, a protocol amendment, reorganization of the Statistical Center, creation of a Transition Committee, development of materials for SELECT Study Sites, development of procedures to close Study Sites, and revision of data collection procedures and the process by which to contact participants. At the time of the publication of the primary SELECT results in December 2008, there were 32,569 men alive and currently active in the trial. As of 31 December 2011, 17,761 participants had been registered to the CFU study. This number is less than had been anticipated due to unforeseen difficulties with local Study Site institutional review boards (IRBs). However, from this cohort, we estimate that an additional 580 prostate cancer cases and 215 Gleason 7 or higher grade cancers will be identified. Over 109,000 individual items have been mailed to participants. Active SELECT ancillary studies have continued. The substantial SELECT biorepository is available to researchers; requests to use the specimens are reviewed for feasibility and scientific merit. As of April 2012, 12 proposals had been approved. The accrual goal of the follow-up study was not met, limiting our power to address the study objectives satisfactorily. The CFU study is also dependent on a number of factors including continued funding, continued interest of investigators in the biorepository, and the continued contribution of the participants. Our experience may be less pertinent to investigators who wish to follow participants in a treatment trial or participants in prevention trials in other medical areas. Extended follow-up of participants in prevention research is important to study the long-term effects of the interventions, such as those used in SELECT. The approach taken by SELECT investigators was to continue to follow participants centrally via an annual questionnaire and with a web-based option. The participants enrolled in the CFU study represent a large, well-characterized, generally healthy cohort. The CFU has enabled us to collect additional prostate and other cancer endpoints and longer follow-up on the almost 18,000 participants enrolled. The utility of the extensive biorepository that was developed during the course of the SELECT is enhanced by longer follow-up.

Moving a Randomized Clinical Trial into an Observational Cohort

PubMed Central

Goodman, Phyllis J.; Hartline, Jo Ann; Tangen, Catherine M.; Crowley, John J.; Minasian, Lori M.; Klein, Eric A.; Cook, Elise D.; Darke, Amy K.; Arnold, Kathryn B.; Anderson, Karen; Yee, Monica; Meyskens, Frank L.; Baker, Laurence H.

2013-01-01

Background The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double blind, placebo-controlled prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo. The independent Data and Safety Monitoring Committee recommended the discontinuation of study supplements because of the lack of efficacy for risk reduction and because futility analyses demonstrated no possibility of benefit of the supplements to the anticipated degree (25% reduction in prostate cancer incidence) with additional follow-up. Study leadership agreed that the randomized trial should be terminated but believed that the cohort should be maintained and followed as the additional follow-up would contribute important information to the understanding of the biologic consequences of the intervention. Since the participants no longer needed to be seen in person to assess acute toxicities or to be given study supplements, it was determined that the most efficient and cost-effective way to follow them was via a central coordinated effort. Purpose A number of changes were necessary at the local Study Sites and SELECT Statistical Center to transition to following participants via a Central Coordinating Center. We describe the transition process from a randomized clinical trial to the observational Centralized Follow-up (CFU) study. Methods The process of transitioning SELECT, implemented at more than 400 Study Sites across the United States, Canada and Puerto Rico, entailed many critical decisions and actions including updates to online documents such as the SELECT Workbench and Study Manual, a protocol amendment, reorganization of the Statistical Center, creation of a Transition Committee, development of materials for SELECT Study Sites, development of procedures to close Study Sites, and revision of data collection procedures and the process by which to contact participants. Results At the time of the publication of the primary SELECT results in December 2008, there were 32,569 men alive and currently active in the trial. As of December 31, 2011, 17,761 participants had been registered to the CFU study. This number is less than had been anticipated due to unforeseen difficulties with local Study Site IRBs. However, from this cohort we estimate that an additional 580 prostate cancer cases and 215 Gleason 7 or higher cancers will be identified. Over 109,000 individual items have been mailed to participants. Active SELECT ancillary studies have continued. The substantial SELECT biorepository is available to researchers; requests to use the specimens are reviewed for feasibility and scientific merit. As of April 2012, 12 proposals had been approved. Limitations The accrual goal of the follow-up study was not met, limiting our power to address the study objectives satisfactorily. The CFU study is also dependent on a number of factors including continued funding, continued interest of investigators in the biorepository and the continued contribution of the participants. Our experience may be less pertinent to investigators who wish to follow participants in a treatment trial or participants in prevention trials in other medical areas. Conclusions Extended follow-up of participants in prevention research is important to study the long-term effects of the interventions, such as those used in SELECT. The approach taken by SELECT investigators was to continue to follow participants centrally via an annual questionnaire and with a web-based option. The participants enrolled in the CFU study represent a large, well-characterized, generally healthy cohort. The CFU has enabled us to collect additional prostate and other cancer endpoints and longer follow-up on the almost 18,000 participants enrolled. The utility of the extensive biorepository that was developed during the course of the SELECT is enhanced by longer follow-up. PMID:23064404

An Overview of Randomization and Minimization Programs for Randomized Clinical Trials

PubMed Central

Saghaei, Mahmoud

2011-01-01

Randomization is an essential component of sound clinical trials, which prevents selection biases and helps in blinding the allocations. Randomization is a process by which subsequent subjects are enrolled into trial groups only by chance, which essentially eliminates selection biases. A serious consequence of randomization is severe imbalance among the treatment groups with respect to some prognostic factors, which invalidate the trial results or necessitate complex and usually unreliable secondary analysis to eradicate the source of imbalances. Minimization on the other hand tends to allocate in such a way as to minimize the differences among groups, with respect to prognostic factors. Pure minimization is therefore completely deterministic, that is, one can predict the allocation of the next subject by knowing the factor levels of a previously enrolled subject and having the properties of the next subject. To eliminate the predictability of randomization, it is necessary to include some elements of randomness in the minimization algorithms. In this article brief descriptions of randomization and minimization are presented followed by introducing selected randomization and minimization programs. PMID:22606659

Phase II trial of CoQ10 for ALS finds insufficient evidence to justify Phase III

PubMed Central

Kaufmann, Petra; Thompson, John L.P.; Levy, Gilberto; Buchsbaum, Richard; Shefner, Jeremy; Krivickas, Lisa S.; Katz, Jonathan; Rollins, Yvonne; Barohn, Richard J.; Jackson, Carlayne E.; Tiryaki, Ezgi; Lomen-Hoerth, Catherine; Armon, Carmel; Tandan, Rup; Rudnicki, Stacy A.; Rezania, Kourosh; Sufit, Robert; Pestronk, Alan; Novella, Steven P.; Heiman-Patterson, Terry; Kasarskis, Edward J.; Pioro, Erik P.; Montes, Jacqueline; Arbing, Rachel; Vecchio, Darleen; Barsdorf, Alexandra; Mitsumoto, Hiroshi; Levin, Bruce

2010-01-01

Objective Amyotrophic lateral sclerosis (ALS) is a devastating, and currently incurable, neuromuscular disease in which oxidative stress and mitochondrial impairment are contributing to neuronal loss. Coenzyme Q10 (CoQ10), an antioxidant and mitochondrial cofactor, has shown promise in ALS transgenic mice, and in clinical trials for neurodegenerative diseases other than ALS. Our aims were to choose between two high doses of CoQ10 for ALS, and to determine if it merits testing in a Phase III clinical trial. Methods We designed and implemented a multi-center trial with an adaptive, two-stage, bias-adjusted, randomized, placebo-controlled, double-blind, Phase II design (n=185). The primary outcome in both stages was decline in the ALS Functional Rating Scale-revised (ALSFRSr) score over 9 months. Stage 1 (dose selection, 35 participants per group) compared CoQ10 doses of 1,800 and 2,700 mg/day. Stage 2 (futility test, 75 patients per group) compared the dose selected in Stage 1 against placebo. Results Stage 1 selected the 2,700 mg dose. In Stage 2, the pre-specified primary null hypothesis that this dose is superior to placebo was not rejected. It was rejected, however, in an accompanying pre-specified sensitivity test, and further supplementary analyses. Pre-specified secondary analyses showed no significant differences between CoQ10 at 2,700 mg/day and placebo. There were no safety concerns. Interpretation CoQ10 at 2,700 mg daily for 9 months shows insufficient promise to warrant Phase III testing. Given this outcome, the adaptive Phase II design incorporating a dose selection and a futility test avoided the need for a much larger conventional Phase III trial. PMID:19743457

Strategies to tackle the challenges of external beam radiotherapy for liver tumors.

PubMed

Lock, Michael I; Klein, Jonathan; Chung, Hans T; Herman, Joseph M; Kim, Edward Y; Small, William; Mayr, Nina A; Lo, Simon S

2017-05-18

Primary and metastatic liver cancer is an increasingly common and difficult to control disease entity. Radiation offers a non-invasive treatment alternative for these patients who often have few options and a poor prognosis. However, the anatomy and aggressiveness of liver cancer poses significant challenges such as accurate localization at simulation and treatment, management of motion and appropriate selection of dose regimen. This article aims to review the options available and provide information for the practical implementation and/or improvement of liver cancer radiation programs within the context of stereotactic body radiotherapy and image-guided radiotherapy guidelines. Specific patient inclusion and exclusion criteria are presented given the significant toxicity found in certain sub-populations treated with radiation. Indeed, certain sub-populations, such as those with tumor thrombosis or those with larger lesions treated with transarterial chemoembolization, have been shown to have significant improvements in outcome with the addition of radiation and merit special consideration. Implementing a liver radiation program requires three primary challenges to be addressed: (1) immobilization and motion management; (2) localization; and (3) dose regimen and constraint selection. Strategies to deal with motion include simple internal target volume (ITV) expansions, non-gated ITV reduction strategies, breath hold methods, and surrogate marker methods to enable gating or tracking. Localization of the tumor and organs-at-risk are addressed using contrast infusion techniques to take advantage of different normal liver and cancer vascular anatomy, imaging modalities, and margin management. Finally, a dose response has been demonstrated and dose regimens appear to be converging. A more uniform approach to treatment in terms of technique, dose selection and patient selection will allow us to study liver radiation in larger and, hopefully, multicenter randomized studies.

Strategies to tackle the challenges of external beam radiotherapy for liver tumors

PubMed Central

Lock, Michael I; Klein, Jonathan; Chung, Hans T; Herman, Joseph M; Kim, Edward Y; Small, William; Mayr, Nina A; Lo, Simon S

2017-01-01

Primary and metastatic liver cancer is an increasingly common and difficult to control disease entity. Radiation offers a non-invasive treatment alternative for these patients who often have few options and a poor prognosis. However, the anatomy and aggressiveness of liver cancer poses significant challenges such as accurate localization at simulation and treatment, management of motion and appropriate selection of dose regimen. This article aims to review the options available and provide information for the practical implementation and/or improvement of liver cancer radiation programs within the context of stereotactic body radiotherapy and image-guided radiotherapy guidelines. Specific patient inclusion and exclusion criteria are presented given the significant toxicity found in certain sub-populations treated with radiation. Indeed, certain sub-populations, such as those with tumor thrombosis or those with larger lesions treated with transarterial chemoembolization, have been shown to have significant improvements in outcome with the addition of radiation and merit special consideration. Implementing a liver radiation program requires three primary challenges to be addressed: (1) immobilization and motion management; (2) localization; and (3) dose regimen and constraint selection. Strategies to deal with motion include simple internal target volume (ITV) expansions, non-gated ITV reduction strategies, breath hold methods, and surrogate marker methods to enable gating or tracking. Localization of the tumor and organs-at-risk are addressed using contrast infusion techniques to take advantage of different normal liver and cancer vascular anatomy, imaging modalities, and margin management. Finally, a dose response has been demonstrated and dose regimens appear to be converging. A more uniform approach to treatment in terms of technique, dose selection and patient selection will allow us to study liver radiation in larger and, hopefully, multicenter randomized studies. PMID:28588749

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

PubMed

Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

2016-01-01

Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31-0.89] (P value = 0.009). Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency

PubMed Central

Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

2016-01-01

Background Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. Methods From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. Results 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31–0.89] (P value = 0.009). Conclusion Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies. PMID:27716793

Risk of Mycobacterium tuberculosis infection in Somalia: national tuberculin survey 2006.

PubMed

Munim, A; Rajab, Y; Barker, A; Daniel, M; Williams, B

2008-01-01

To estimate the annual risk of tuberculosis (TB) infection (ARTI) in Somalia a tuberculin survey was conducted in February/March 2006. Stratified cluster sampling was carried out within the 18 regions and 101 randomly selected primary schools. Tuberculin testing was done in 10 680 grade 1 schoolchildren. Transverse tuberculin reaction size was measured 72 hours later. The number of children with a satisfactory test read was 10 364. The overall BCG coverage was 54%. Based on frequency distribution of tuberculin reaction sizes, the ARTI in Somalia was estimated at 2.2% (confidence interval: 1.5%-3.2%). There was an annual decline of 2.6% comparing with a previous study in 1956.

Enhancing Informed Choice to Undergo Health Screening: A Systematic Review

PubMed Central

Biesecker, Barbara Bowles; Schwartz, Marc D.; Marteau, Theresa M.

2012-01-01

Objective To assess the effectiveness of health screening interventions aimed at enhancing informed choice. Methods Studies were selected if (1) they were randomized controlled trials conducted between January 1, 2000, and March 30, 2010, (2) participants in one arm underwent a prescreening intervention aimed at improving informed choice, and (3) informed choice was the primary outcome. Results Eight studies that met the inclusion criteria involved screening for prostate, colorectal and breast cancer, and diabetes. Five of the 8 prescreening interventions led to greater informed choice. Conclusions With researchers mindful of the limited number of studies, findings were encouraging, but conclusions regarding the most effective ways of facilitating informed choice for screening are at best tentative. PMID:23985182

Fertility and its relationship with sociocultural factors in Kuwaiti society.

PubMed

Al-Kandari, Y Y

2007-01-01

The aim of this study was to examine the effect of some sociocultural variables on the fertility of Kuwaiti women. A questionnaire was administered to a sample of 7749 married women (aged 15-78 years) selected randomly from 10 primary health care clinics in Kuwait. The fertility rate was 3.58 live births per woman. Fertility was higher among Sunni Muslim women, those of Bedouin ethnicity, and those in a consanguineous marriage (P < 0.001). There was a significant negative relationship between fertility and respondents' educational level, occupation, age at marriage, socioeconomic status and type of marriage (consanguineous or not). There was a positive relationship between fertility and the respondents' age and the family income.

Surgery for congenital choanal atresia.

PubMed

Cedin, Antonio C; Atallah, Alvaro N; Andriolo, Régis B; Cruz, Oswaldo L; Pignatari, Shirley N

2012-02-15

Congenital choanal atresia is a rare abnormality characterized by unilateral or bilateral lack of patency of the posterior end of the nasal cavity. With an incidence of 1:5000 to 1:8000 births, it is twice as prevalent in females as it is in males. Surgical procedures aim to provide adequate functional choanal patency and a low rate of restenosis, avoid harm to any structure in development, enable shorter surgery and hospitalization times, and minimize morbidity and mortality. To evaluate the effectiveness and safety of the available surgical techniques for the treatment of congenital choanal atresia in patients with unilateral and bilateral atresia. We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the search was 31 January 2011. We planned to include parallel randomized or quasi-randomized controlled trials testing surgical approaches for the treatment of congenital atresia (irrespective of gender and age) that evaluated normal/adequate respiratory function (self reported or preserved nasal airway) and restenosis as the main primary outcomes. We did not consider reoperation and non-congenital atresia (e.g. traumatic, iatrogenic atresias) for inclusion. Three review authors independently assessed the titles and abstracts of the identified articles to determine potential relevance. For dichotomous and continuous variables, we planned to calculate risk ratios (relative risks; RR) and mean differences (MD) with 95% confidence intervals (CI), respectively. We planned to use the random-effects model since we were expecting substantial clinical and methodological heterogeneity. No randomized controlled trials were identified. From the 120 reports retrieved using our search strategy, 46 primary studies had the potential to be included since they had tested surgical approaches for choanal atresia. However, we excluded all of them during the final selection process because their study designs did not meet our inclusion criteria. There is no definitive evidence, based on randomized controlled trials, to demonstrate the potential advantages and disadvantages of any specific surgical technique for patients with choanal atresia. Specialists should unify their efforts in multicenter randomized controlled trials that test the effectiveness and safety of different surgical techniques in patients with choanal atresia.

The RANDOM computer program: A linear congruential random number generator

NASA Technical Reports Server (NTRS)

Miles, R. F., Jr.

1986-01-01

The RANDOM Computer Program is a FORTRAN program for generating random number sequences and testing linear congruential random number generators (LCGs). The linear congruential form of random number generator is discussed, and the selection of parameters of an LCG for a microcomputer described. This document describes the following: (1) The RANDOM Computer Program; (2) RANDOM.MOD, the computer code needed to implement an LCG in a FORTRAN program; and (3) The RANCYCLE and the ARITH Computer Programs that provide computational assistance in the selection of parameters for an LCG. The RANDOM, RANCYCLE, and ARITH Computer Programs are written in Microsoft FORTRAN for the IBM PC microcomputer and its compatibles. With only minor modifications, the RANDOM Computer Program and its LCG can be run on most micromputers or mainframe computers.

Primary Prevention of Parent-Child Conflict and Abuse in Iranian Mothers: A Randomized-Controlled Trial

ERIC Educational Resources Information Center

Oveisi, Sonia; Ardabili, Hassan Eftekhare; Dadds, Mark R.; Majdzadeh, Reza; Mohammadkhani, Parvaneh; Rad, Javad Alaqband; Shahrivar, Zahra

2010-01-01

Objective: The aim of this study was to assess whether primary health care settings can be used to engage and provide a preventive intervention to mothers of young children. Methods: Two hundred and twenty-four mothers who had come to the health centers were randomly assigned to either control group (CG: n=116) or intervention group (IG: n = 108).…

Influence of General Self-Efficacy on the Effects of a School-Based Universal Primary Prevention Program of Depressive Symptoms in Adolescents: A Randomized and Controlled Follow-up Study

ERIC Educational Resources Information Center

Possel, Patrick; Baldus, Christiane; Horn, Andrea B.; Groen, Gunter; Hautzinger, Martin

2005-01-01

Background: Depressive disorders in adolescents are a widespread and increasing problem. Prevention seems a promising and feasible approach. Methods: We designed a cognitive-behavioral school-based universal primary prevention program and followed 347 eighth-grade students participating in a randomized controlled trial for three months. Results:…

Somato-Visceral Effects in the Treatment of Dysmenorrhea: Neuromuscular Manual Therapy and Standard Pharmacological Treatment.

PubMed

Barassi, Giovanni; Bellomo, Rosa Grazia; Porreca, Annamaria; Di Felice, Piera Attilia; Prosperi, Loris; Saggini, Raoul

2018-03-01

This study aims to verify whether neuromuscular therapy (NMT) or pharmacology therapy (PT) is more effective for reducing symptoms in women affected by primary dysmenorrhea and the effects associated with each treatment. A controlled, randomized, single-blind clinical trial within the framework of the chair of physical medicine and rehabilitation of the University "G. d'Annunzio" of Chieti-Pescara. The study was conducted on a sample of 60 women suffering from primary dysmenorrhea. Subjects were randomly divided in two groups (A and B). Group A was treated with NMT and group B with PT. Group B was given ibuprofen or naproxen because they are considered the best painkillers for this condition. Group A was treated with 8 neuromuscular manual lumbosacral and abdominal therapy sessions twice per week for 4 weeks. Results were analyzed at the beginning (T0) and end (T1) of the study with a menstrual distress questionnaire, brief pain inventory, and visual analogue scale. Twenty patients from Group A were selected for evaluation of their maintenance of the eventual improvement that was detected in T1 at follow-up (T2). Both therapies had significant short-term effects in reducing the perception and duration of pain. However, NMT appears to give more improvements in the duration of pain. NMT had a long-term effect on perception of pain because patients conserved the positive effects of treatment after 4 weeks. NMT also had a long-term effect on duration of pain because patients conserved benefits of treatment, but this improvement started to decrease after 4 weeks. In the treatment of primary dysmenorrhea, NMT represents a valid therapeutic alternative method to PT. NMT is free from potential adverse effects of analgesics, is noninvasive, and is easy to perform.

Dignity Impact as a Primary Outcome Measure for Dignity Therapy.

PubMed

Scarton, Lisa; Oh, Sungho; Sylvera, Ashley; Lamonge, Ralph; Yao, Yingwei; Chochinov, Harvey; Fitchett, George; Handzo, George; Emanuel, Linda; Wilkie, Diana

2018-01-01

Feasibility of dignity therapy (DT) is well established in palliative care. Evidence of its efficacy, however, has been inconsistent and may stem from DT's primary effects differing from the outcomes measured in previous studies. We proposed that DT effects were in the spiritual domain and created a new outcome measure, Dignity Impact Scale (DIS), from items previously used in a large randomized controlled trial (RCT). The purpose of this secondary analysis study was to examine properties of a new measure of dignity impact. Using the DIS, we conducted reanalysis of posttest data from a large 3-arm, multi-site RCT study. Participants were receiving hospice/palliative care (n = 326, 50.6% female, mean age = 65.1 years, 89.3% white, all with a terminal illness with 6 months or less life expectancy). They had been randomized to standard palliative care (n = 111), client-centered care (n = 107), or DT (n = 108). The 7-item DIS was derived from selected items in a posttest DT Patient Feedback Questionnaire. The DIS had strong internal consistency (α = 0.85). The DT group mean DIS score (21.4 ± 5.0) was significantly higher than the usual care group mean score (17.7 ± 5.5; t = 5.2, df = 216, P < .001) and a client-centered intervention group mean score (17.9 ± 4.9; t = 5.2, df = 213, P < .001). We found that, compared to both other groups, patients who received DT reported significantly higher DIS ratings, which is consistent with the DT focus on meaning-making, preparation for death, and life completion tasks. We propose that the DIS be used as the primary outcome measure in evaluating the effects of DT.

Adverse events analysis as an educational tool to improve patient safety culture in primary care: A randomized trial

PubMed Central

2011-01-01

Background Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following: - Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia. - Find and analyze educational tools to improve patient safety culture in primary care. - Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. Design and methods Design Experimental unifactorial study of two groups, control and intervention. Study population Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. Sample From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. Intervention Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group-either intervention or control-through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After the intervention has ended, the survey will once again be provided to all participants. Outcome measures Change in safety culture as measured by Hospital Survey on Patient Safety Culture CONSORT Extension for Non-Pharmacologic Treatments 2008 was applied. Discussion The most significant limitations on the project are related to selecting a tool to measure the safety environment, the training calendar of residents in Family and Community Medicine in last year of studies and the no-answer bias inherent to research conducted through self-administered surveys. The development and application of a safety culture in the health sector, specifically in primary care, is as yet limited. Thus, identifying the strengths and weaknesses in the safety environment may assist in designing strategies for improvement in the primary care health centers of our region. Trial registration ISRCTN: ISRCTN41911128 PMID:21672197

Adverse events analysis as an educational tool to improve patient safety culture in primary care: a randomized trial.

PubMed

González-Formoso, Clara; Martín-Miguel, María Victoria; Fernández-Domínguez, Ma José; Rial, Antonio; Lago-Deibe, Fernando Isidro; Ramil-Hermida, Luis; Pérez-García, Margarita; Clavería, Ana

2011-06-14

Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following:--Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.--Find and analyze educational tools to improve patient safety culture in primary care.--Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. Experimental unifactorial study of two groups, control and intervention. Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group--either intervention or control--through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After the intervention has ended, the survey will once again be provided to all participants. Change in safety culture as measured by Hospital Survey on Patient Safety CultureCONSORT Extension for Non-Pharmacologic Treatments 2008 was applied. The most significant limitations on the project are related to selecting a tool to measure the safety environment, the training calendar of residents in Family and Community Medicine in last year of studies and the no-answer bias inherent to research conducted through self-administered surveys.The development and application of a safety culture in the health sector, specifically in primary care, is as yet limited. Thus, identifying the strengths and weaknesses in the safety environment may assist in designing strategies for improvement in the primary care health centers of our region. ISRCTN: ISRCTN41911128.

Prevalence of undifferentiated fever in adults of Rawalpindi having primary dengue fever.

PubMed

Zafar, Humaira; Hayyat, Abbas; Akhtar, Naeem; Rizwan, Syeda Fatima

2013-06-01

The objectives of the study were to highlight early subclinical presentation of dengue viral infection (DVI) as an undifferentiated febrile illness. The descriptive cross-sectional study was carried out at Microbiology Department, Rawalpindi Medical College from March to September 2009. Stratified random sampling was used to select subjects from various urban and rural areas of Rawalpindi, and Serum IgG anti-dengue antibodies were detected by using 3rd generation enzyme-linked immunosorbent assay (ELISA). Out of the total 240 subjects, 69 (28.75%) were found to be positive for anti-dengue IgG antibodies. Of the positive cases, 41 (59.4%) - comprising 31 (44.9%) urban residents - and 10 (14.4%) rural residents presented with a previous history of undifferentiated fever (p<0.05). It was concluded that primary DVI can present as subclinical form in healthy population residing in rural and urban areas of Rawalpindi, which is an alarming situation indicating the spread of disease in the study area.

Missed opportunities in primary care: the importance of identifying depression through screening, family history, and chronic disease management.

PubMed

Maradiegue, Ann H; Khan, Fakiha

2013-02-01

This study explored the adequacy of depression screening in a community health center. The medical charts of individuals (N = 90) enrolled at a community health center were randomly selected, reviewed, and compared to current standard-of-care guidelines for four elements: family history, screening for depression, control of chronic illnesses, and missed opportunities for preventive care. Family history documentation collected by the providers was limited and 44.4% had no family history. There was no routine depression screening process, although 48.9% of the clients had red flags (warning signals) for depression. Laboratory values used for screening control of chronic disease in the medical records were: fasting glucose levels ⩽100 mg/dL (46%), total cholesterol levels ⩽200 mg/dL (38%), and blood pressure ⩽120/80 mmHg (23%). The results highlight the need to focus on depression screening as part of preventive care and the management of chronic disease in the primary care setting. Copyright 2013, SLACK Incorporated.

Managing anemia in low-income toddlers: barriers, challenges and context in primary care.

PubMed

Crowell, Rebecca; Pierce, Michelle B; Ferris, Ann M; Slivka, Hilda; Joyce, Patricia; Bernstein, Bruce A; Russell-Curtis, Suzanne

2005-11-01

Iron-deficiency remains a concern among low-income toddlers in the U.S. This formative study describes how primary care providers serving high-risk 1- to 3-year-old children in an urban ambulatory care setting approach anemia. Data collection included a retrospective review of randomly selected medical records (n=264) and semi-structured interviews with clinicians (n=41). Thirty-eight percent of the children presented with anemia (Hgb < 11.0 g/dl) at least once between 12 and 36 months of age. Just under half of these children were treated for anemia. Follow-up laboratories for iron-treated children were completed within 35 days in 16% of cases (median: 3 months). Interviews identified four key themes (iron-deficiency, communication, poverty, system) running through the two major categories of prevention and treatment. Treatment cut-points were variable. While providers felt clinically comfortable with anemia, they felt burdened and challenged by follow-up. Communication and system barriers weighed most heavily on perceived treatment outcomes.