Coordination of international multicenter studies: Governance and administrative structure

A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. the organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. the elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. the experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (World-SAFE), illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators. the English version of this paper is available too at: http://www.insp.mx/salud/index.html.Univ N Carolina, Chapel Hill, NC USAUniversidade Federal de São Paulo, Escola Paulista Med, São Paulo, BrazilUniv Philippines, Manila, PhilippinesUniv La Frontera, Temuco, ChileUniversidade Federal de São Paulo, Escola Paulista Med, São Paulo, BrazilWeb of Scienc

Reliability and validity of a nutrition and physical activity environmental self-assessment for child care

<p>Abstract</p> <p>Background</p> <p>Few assessment instruments have examined the nutrition and physical activity environments in child care, and none are self-administered. Given the emerging focus on child care settings as a target for intervention, a valid and reliable measure of the nutrition and physical activity environment is needed.</p> <p>Methods</p> <p>To measure inter-rater reliability, 59 child care center directors and 109 staff completed the self-assessment concurrently, but independently. Three weeks later, a repeat self-assessment was completed by a sub-sample of 38 directors to assess test-retest reliability. To assess criterion validity, a researcher-administered environmental assessment was conducted at 69 centers and was compared to a self-assessment completed by the director. A weighted kappa test statistic and percent agreement were calculated to assess agreement for each question on the self-assessment.</p> <p>Results</p> <p>For inter-rater reliability, kappa statistics ranged from 0.20 to 1.00 across all questions. Test-retest reliability of the self-assessment yielded kappa statistics that ranged from 0.07 to 1.00. The inter-quartile kappa statistic ranges for inter-rater and test-retest reliability were 0.45 to 0.63 and 0.27 to 0.45, respectively. When percent agreement was calculated, questions ranged from 52.6% to 100% for inter-rater reliability and 34.3% to 100% for test-retest reliability. Kappa statistics for validity ranged from -0.01 to 0.79, with an inter-quartile range of 0.08 to 0.34. Percent agreement for validity ranged from 12.9% to 93.7%.</p> <p>Conclusion</p> <p>This study provides estimates of criterion validity, inter-rater reliability and test-retest reliability for an environmental nutrition and physical activity self-assessment instrument for child care. Results indicate that the self-assessment is a stable and reasonably accurate instrument for use with child care interventions. We therefore recommend the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) instrument to researchers and practitioners interested in conducting healthy weight intervention in child care. However, a more robust, less subjective measure would be more appropriate for researchers seeking an outcome measure to assess intervention impact.</p

A public health vs a risk-based intervention to improve cardiovascular health in elementary school children : The cardiovascular health in children study

Objectives. This study sought to determine the population effects of both classroom-based and risk-based interventions designed to reduce cardiovascular disease risk factors in children. Methods. Elemenary school children (n = 2109; age range 7-12 years) were randomized by school to a classroom-based intervention for all third and fourth graders, a risk-based intervention only for those with 1 or more cardiovascular disease risk factors, or a control group. The 8-week interventions involved both knowledge-attitude and physical activity components. Results. School-level analyses showed that physical activity in the risk-based group and posttest knowledge in the classroom-based groups were significantly higher than in the control group. With regard to trends shown by individual-level analyses, cholesterol dropped more in the classroom-based than in the control group, and skinfold thickness decreased 2,9% in the classroom-based group and 3.2% in the risk-based group (as compared with a 1.1% increase in the control group). Conclusions. Both classroom-based and risk-based interventions had positive effects on physical activity and knowledge, with trends toward reduced body fat and cholesterol. However, the classroom-based approach was easier to implement and evidenced stronger results than the risk-based intervention

Addressing healthcare needs of people living below the poverty line: a rapid assessment of the Andhra Pradesh Health Insurance Scheme

BACKGROUND: Families living below the poverty line in countries which do not have universal healthcare coverage are drawn into indebtedness and bankruptcy. The state of Andhra Pradesh in India established the Rajiv Aarogyasri Community Health Insurance Scheme (RACHIS) in 2007 with the aim of breaking this cycle by improving the access of below the poverty line (BPL) families to secondary and tertiary healthcare. It covered a wide range of surgical and medical treatments for serious illnesses requiring specialist healthcare resources not always available at district-level government hospitals. The impact of this scheme was evaluated by a rapid assessment, commissioned by the government of Andhra Pradesh. The aim of the assessment was to explore the contribution of the scheme to the reduction of catastrophic health expenditure among the poor and to recommend ways by which delivery of the scheme could be improved. We report the findings of this assessment. METHODS: Two types of data were used for the assessment. Patient data pertaining to 89 699 treatment requests approved by the scheme during its first 18 months were examined. Second, surveys of scheme beneficiaries and providers were undertaken in 6 randomly selected districts of Andhra Pradesh. RESULTS: This novel scheme was beginning to reach the BPL households in the state and providing access to free secondary and tertiary healthcare to seriously ill poor people. CONCLUSION: An integrated model encompassing primary, secondary and tertiary care would be of greater benefit to families below the poverty line and more cost-effective for the government. There is considerable potential for the government to build on this successful start and to strengthen equity of access and the quality of care provided by the scheme

Statistical methodologies to pool across multiple intervention studies

Combining and analyzing data from heterogeneous randomized controlled trials of complex multiple-component intervention studies, or discussing them in a systematic review, is not straightforward. The present article describes certain issues to be considered when combining data across studies, based on discussions in an NIH-sponsored workshop on pooling issues across studies in consortia (see Belle et al. in Psychol Aging, 18(3):396–405, 2003). Several statistical methodologies are described and their advantages and limitations are explored. Whether weighting the different studies data differently, or via employing random effects, one must recognize that different pooling methodologies may yield different results. Pooling can be used for comprehensive exploratory analyses of data from RCTs and should not be viewed as replacing the standard analysis plan for each study. Pooling may help to identify intervention components that may be more effective especially for subsets of participants with certain behavioral characteristics. Pooling, when supported by statistical tests, can allow exploratory investigation of potential hypotheses and for the design of future interventions

Performance of Lipoarabinomannan Assay using Cerebrospinal fluid for the diagnosis of Tuberculous meningitis among HIV patients.

Background: The diagnostic utility of the Mycobacteria tuberculosis lipoarabinomannan (TB-LAM) antigen lateral flow assay on cerebrospinal fluid (CSF) for the diagnosis of tuberculous meningitis (TBM) has not been extensively studied and the few published studies have conflicting results. Methods: Lumbar CSF from 59 HIV-positive patients with suspected TBM was tested with TB-LAM and Xpert MTB/Rif Ultra. The diagnostic performance of CSF TB-LAM was compared to positive CSF Xpert MTB/Rif Ultra (definite TBM) and a composite reference of probable or definite TBM according to the uniform case definition.  Results: Of 59 subjects, 12 (20%) had definite TBM and five (9%) had probable TBM. With reference to definite TBM, CSF TB-LAM assay had a diagnostic sensitivity of 33% and specificity of 96%. When compared to a composite reference of definite or probable TBM, the sensitivity was 24% and specificity was 95%. There were two false positive tests with TB-LAM (3+ grade). In-hospital mortality in CSF TB-LAM positive patients was 17% compared to 0% in those with definite TBM by Xpert MTB/Rif Ultra but negative LAM. Conclusions: Lumbar CSF TB-LAM has a poor performance in diagnosing TBM. Both urine TB-LAM and Xpert Ultra should be further investigated in the diagnosis of TBM

Impact of social isolation on mortality and morbidity in 20 high-income, middle-income and low-income countries in five continents

Objective: To examine the association between social isolation and mortality and incident diseases in middle-aged adults in urban and rural communities from high-income, middle-income and low-income countries.Design: Population-based prospective observational study.Setting: Urban and rural communities in 20 high income, middle income and low income.Participants: 119 894 community-dwelling middle-aged adults.Main outcome measures: Associations of social isolation with mortality, cardiovascular death, non-cardiovascular death and incident diseases.Results: Social isolation was more common in middle-income and high-income countries compared with low-income countries, in urban areas than rural areas, in older individuals and among women, those with less education and the unemployed. It was more frequent among smokers and those with a poorer diet. Social isolation was associated with greater risk of mortality (HR of 1.26, 95% CI: 1.17 to 1.36), incident stroke (HR: 1.23, 95% CI: 1.07 to 1.40), cardiovascular disease (HR: 1.15, 95% CI: 1.05 to 1.25) and pneumonia (HR: 1.22, 95% CI: 1.09 to 1.37), but not cancer. The associations between social isolation and mortality were observed in populations in high-income, middle-income and low-income countries (HR (95% CI): 1.69 (1.32 to 2.17), 1.27 (1.15 to 1.40) and 1.47 (1.25 to 1.73), respectively, interaction p=0.02). The HR associated with social isolation was greater in men than women and in younger than older individuals. Mediation analyses for the association between social isolation and mortality showed that unhealthy behaviours and comorbidities may account for about one-fifth of the association.Conclusion: Social isolation is associated with increased risk of mortality in countries at different economic levels. The increasing share of older people in populations in many countries argues for targeted strategies to mitigate its adverse effects

Parent’s Physical Activity Associated With Preschooler Activity in Underserved Populations

INTRODUCTION: In the U.S., children from low-income families are more likely to be obese. The impact of parent modeling of physical activity (PA) and sedentary behaviors in low-income American ethnic minorities is unclear, and studies examining objective measures of preschooler and parent PA are sparse. METHODS: This cross-sectional study examined 1,003 parent-child pairs who were of low income, largely Latino and African American, and living in one of two geographically disparate metropolitan areas in the U.S. Parents and children wore GT3X/GT3X+ accelerometers for an average of >12 hours/day (7:00am-9:00pm) for 1 week (September 2012 to May 2014). Analysis occurred in 2015-2016. RESULTS: About 75% of children were Latino and >10% were African American. Mean child age was 3.9 years. The majority of children (60%) were normal weight (BMI ≥50th and <85th percentiles), and more than a third were overweight/obese. Children's total PA was 6.03 hours/day, with 1.5 hours spent in moderate to vigorous PA (MVPA). Covariate-adjusted models showed a monotonic, positive association between parent and child minutes of sedentary behavior (β=0.10, 95% CI=0.06, 0.15) and light PA (β=0.06; 95% CI=0.03, 0.09). Child and parent MVPA were positively associated up to 40 minutes/day of parent MVPA, but an inverse association was observed when parental MVPA was beyond 40 minutes/day (p=0.002). CONCLUSIONS: Increasing parental PA and reducing sedentary behavior correlate with increased PA-related behaviors in children. However, more work is needed to understand the impact of high levels of parental MVPA on the MVPA levels of their children

Development and validation of the Patient‐Physician Relationship Scale among patients with irritable bowel syndrome

BackgroundAn effective patient‐physician relationship (PPR) is essential to the care of patients with irritable bowel syndrome (IBS). We sought to develop and validate an IBS‐specific instrument to measure expectations of the PPR.MethodsWe conducted structured focus groups about PPRs with 12 patients with IBS. Qualitative analysis was used to generate a questionnaire (the Patient‐Physician Relationship Scale [PPRS]), which was modified with input from content experts and usability testing. For validation, we administered it online to US adults with IBS. Participants also completed the Functional Bowel Disorder Severity Index, the Rome III Adult Functional gastrointestinal (GI) Disorder Criteria Questionnaire, and modified versions of the Communication Assessment Tool (CAT‐15) and Patient‐Doctor Relationship Questionnaire (PDRQ‐9). We performed principal components factor analysis for the PPRS.Key ResultsThe PPRS contained 32 questions with responses on a 7‐item Likert scale. Themes included interpersonal features, clinical care expectations, and aspects of communication. One thousand and fifty‐four eligible individuals completed the survey (88% completion rate). Most participants were middle aged (mean 48 years, SD 16.3), white (90%), and female (86%). Factor analysis showed only one relevant factor, relating to quality of PPR. The final scale ranged from possible‐96 to +96 (mean 62.0, SD 37.6). It correlated moderately with the CAT‐15 (r=.40, P<.001) and PDRQ‐9 (r=.30, P<.001), establishing concurrent validity.Conclusions & InferencesWe describe the development and validation of the first questionnaire for use in measuring patient expectations of the PPR, which can be used for future outcomes studies and training physicians.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138227/1/nmo13106.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/138227/2/nmo13106_am.pd