Use of Objective Metrics in Dynamic Facial Reanimation: A Systematic Review.

PubMed

Revenaugh, Peter C; Smith, Ryan M; Plitt, Max A; Ishii, Lisa; Boahene, Kofi; Byrne, Patrick J

2018-06-21

Facial nerve deficits cause significant functional and social consequences for those affected. Existing techniques for dynamic restoration of facial nerve function are imperfect and result in a wide variety of outcomes. Currently, there is no standard objective instrument for facial movement as it relates to restorative techniques. To determine what objective instruments of midface movement are used in outcome measurements for patients treated with dynamic methods for facial paralysis. Database searches from January 1970 to June 2017 were performed in PubMed, Embase, Cochrane Library, Web of Science, and Scopus. Only English-language articles on studies performed in humans were considered. The search terms used were ("Surgical Flaps"[Mesh] OR "Nerve Transfer"[Mesh] OR "nerve graft" OR "nerve grafts") AND (face [mh] OR facial paralysis [mh]) AND (innervation [sh]) OR ("Face"[Mesh] OR facial paralysis [mh]) AND (reanimation [tiab]). Two independent reviewers evaluated the titles and abstracts of all articles and included those that reported objective outcomes of a surgical technique in at least 2 patients. The presence or absence of an objective instrument for evaluating outcomes of midface reanimation. Additional outcome measures were reproducibility of the test, reporting of symmetry, measurement of multiple variables, and test validity. Of 241 articles describing dynamic facial reanimation techniques, 49 (20.3%) reported objective outcome measures for 1898 patients. Of those articles reporting objective measures, there were 29 different instruments, only 3 of which reported all outcome measures. Although instruments are available to objectively measure facial movement after reanimation techniques, most studies do not report objective outcomes. Of objective facial reanimation instruments, few are reproducible and able to measure symmetry and multiple data points. To accurately compare objective outcomes in facial reanimation, a reproducible, objective, and universally applied instrument is needed.

[Systematic development of a scale for determination of health-related quality of life in multiple trauma patients. The Polytrauma Outcome (POLO) Chart].

PubMed

Pirente, N; Bouillon, B; Schäfer, B; Raum, M; Helling, H J; Berger, E; Neugebauer, E

2002-05-01

Even years after having sustained multiple injuries patients often suffer from its sequelae. These comprise restrictions in physical function, but also pain, social and psychological impairments. Although the Meran Consensus Conference in 1990 defined the contents of "quality of life" (QoL) measures in surgery, still no instrument is available for the valid assessment of all relevant QoL domains in multiple injured patients. This paper describes the systematic development of a modular instrument for the assessment of health related QoL. Within three phases (phase I: generation of items, phase II: item reduction, phase III: pre-testing in 70 multiple injured and control patients) a questionnaire of 57 items was developed, which measures all relevant trauma-related aspects of QoL after acute hospital care. In combination with the Glascow Outcome Scale (GOS), the EUROQOL and the SF-36, the newly developed instrument builds the Polytrauma Outcome Chart (POLO-Chart) which will also be used as "Part E" for outcome assessment within the "Trauma registry" of the German Society for Trauma Surgery. In phase IV, the POLO-Chart will finally be validated in five trauma centres (Celle, Essen, Hanover, Cologne und Munich).

Do Multiple Concussions Lead to Cumulative Cognitive Deficits? A Literature Review.

PubMed

Yumul, Joy Noelle; McKinlay, Audrey

2016-11-01

A concussion is an important health concern for children and adolescents, particularly in the context of sporting injuries. Some research suggests a cumulative effect from multiple concussions (also referred to as mild traumatic brain injury), which creates a dilemma when considering how to manage children and young persons who may experience multiple concussive events within a sporting season. However, there is very little research regarding the outcomes of multiple concussions and their optimal management. The purpose of this review is to evaluate the evidence regarding the cognitive outcomes of multiple concussions. After assessing the eligibility of the articles from the literature search, 7 studies were identified and included in the review. In most of the available literature, the cognitive outcomes related to multiple concussions are measured during the same developmental age as when the injuries happened. Moreover, most studies that investigated multiple concussions are focused on sports-related injuries, and only some are conducted in children and adolescents in the general population. The current evidence is inconclusive; whereas some studies reported adverse outcomes, others reported null findings. The studies that reported adverse or cumulative effects based their findings on worse cognitive outcomes, more subjective symptoms, and prolonged recovery postinjury. II. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

THE STATISTICAL ANALYSIS OF DISCRETE AND CONTINUOUS OUTCOMES USING DESIRABILITY FUNCTIONS.

EPA Science Inventory

Multiple types of outcomes are sometimes measured on each animal in toxicology dose-response experiments. In this paper we introduce a method of deriving a composite score for a dose-response experiment that combines information from discrete and continuous outcomes through the ...

Strength, Multijoint Coordination, and Sensorimotor Processing Are Independent Contributors to Overall Balance Ability

PubMed Central

Lawrence, Emily L.; Cesar, Guilherme M.; Bromfield, Martha R.; Peterson, Richard; Valero-Cuevas, Francisco J.; Sigward, Susan M.

2015-01-01

For young adults, balance is essential for participation in physical activities but is often disrupted following lower extremity injury. Clinical outcome measures such as single limb balance (SLB), Y-balance (YBT), and the single limb hop and balance (SLHB) tests are commonly used to quantify balance ability following injury. Given the varying demands across tasks, it is likely that such outcome measures provide useful, although task-specific, information. But the extent to which they are independent and contribute to understanding the multiple contributors to balance is not clear. Therefore, the purpose of this study was to investigate the associations among these measures as they relate to the different contributors to balance. Thirty-seven recreationally active young adults completed measures including Vertical Jump, YBT, SLB, SLHB, and the new Lower Extremity Dexterity test. Principal components analysis revealed that these outcome measures could be thought of as quantifying the strength, multijoint coordination, and sensorimotor processing contributors to balance. Our results challenge the practice of using a single outcome measure to quantify the naturally multidimensional mechanisms for everyday functions such as balance. This multidimensional approach to, and interpretation of, multiple contributors to balance may lead to more effective, specialized training and rehabilitation regimens. PMID:26665007

Evaluation of the Environmental Scoring System in Multiple Child Asthma Intervention Programs in Boston, Massachusetts.

PubMed

Dong, Zhao; Nath, Anjali; Guo, Jing; Bhaumik, Urmi; Chin, May Y; Dong, Sherry; Marshall, Erica; Murphy, Johnna S; Sandel, Megan T; Sommer, Susan J; Ursprung, W W Sanouri; Woods, Elizabeth R; Reid, Margaret; Adamkiewicz, Gary

2018-01-01

To test the applicability of the Environmental Scoring System, a quick and simple approach for quantitatively measuring environmental triggers collected during home visits, and to evaluate its contribution to improving asthma outcomes among various child asthma programs. We pooled and analyzed data from multiple child asthma programs in the Greater Boston Area, Massachusetts, collected in 2011 to 2016, to examine the association of environmental scores (ES) with measures of asthma outcomes and compare the results across programs. Our analysis showed that demographics were important contributors to variability in asthma outcomes and total ES, and largely explained the differences among programs at baseline. Among all programs in general, we found that asthma outcomes were significantly improved and total ES significantly reduced over visits, with the total Asthma Control Test score negatively associated with total ES. Our study demonstrated that the Environmental Scoring System is a useful tool for measuring home asthma triggers and can be applied regardless of program and survey designs, and that demographics of the target population may influence the improvement in asthma outcomes.

Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis.

PubMed

Ratzer, Rikke; Iversen, Pernille; Börnsen, Lars; Dyrby, Tim B; Romme Christensen, Jeppe; Ammitzbøll, Cecilie; Madsen, Camilla Gøbel; Garde, Ellen; Lyksborg, Mark; Andersen, Birgit; Hyldstrup, Lars; Sørensen, Per Soelberg; Siebner, Hartwig R; Sellebjerg, Finn

2016-06-01

There is a large unmet need for treatments for patients with progressive multiple sclerosis (MS). Phase 2 studies with cerebrospinal fluid (CSF) biomarker outcomes may be well suited for the initial evaluation of efficacious treatments. To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS. In this open-label phase 2A study, 15 primary progressive and 15 secondary progressive MS patients received oral methylprednisolone pulse treatment for 60 weeks. Primary outcome was changes in CSF concentrations of osteopontin. Secondary outcomes were other CSF biomarkers of inflammation, axonal damage and demyelination; clinical scores; magnetic resonance imaging measures of disease activity, magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI); motor evoked potentials; and bone density scans. We found no change in the CSF concentration of osteopontin, but we observed significant improvement in clinical scores, MTR, DTI and some secondary CSF outcome measures. Adverse events were well-known side effects to methylprednisolone. Monthly methylprednisolone pulse treatment was safe, but had no effect on the primary outcome. However, improvements in secondary clinical and MRI outcome measures suggest that this treatment regimen may have a beneficial effect in progressive MS. © The Author(s), 2015.

The multiple sclerosis work difficulties questionnaire: translation and cross-cultural adaptation to Turkish and assessment of validity and reliability.

PubMed

Kahraman, Turhan; Özdoğar, Asiye Tuba; Honan, Cynthia Alison; Ertekin, Özge; Özakbaş, Serkan

2018-05-09

To linguistically and culturally adapt the Multiple Sclerosis Work Difficulties Questionnaire-23 (MSWDQ-23) for use in Turkey, and to examine its reliability and validity. Following standard forward-back translation of the MSWDQ-23, it was administered to 124 people with multiple sclerosis (MS). Validity was evaluated using related outcome measures including those related to employment status and expectations, disability level, fatigue, walking, and quality of life. Randomly selected participants were asked to complete the MSWDQ-23 again to assess test-retest reliability. Confirmatory factor analysis on the MSWDQ-23 demonstrated a good fit for the data, and the internal consistency of each subscale was excellent. The test-retest reliability for the total score, psychological/cognitive barriers, physical barriers, and external barriers subscales were high. The MSWDQ-23 and its subscales were positively correlated with the employment, disability level, walking, and fatigue outcome measures. This study suggests that the Turkish version of MSWDQ-23 has high reliability and adequate validity, and it can be used to determine the difficulties faced by people with multiple sclerosis in workplace. Moreover, the study provides evidence about the test-retest reliability of the questionnaire. Implications for rehabilitation Multiple sclerosis affects young people of working age. Understanding work-related problems is crucial to enhance people with multiple sclerosis likelihood of maintaining their job. The Multiple Sclerosis Work Difficulties Questionnaire-23 (MSWDQ-23) is a valid and reliable measure of perceived workplace difficulties in people with multiple sclerosis: we presented its validation to Turkish. Professionals working in the field of vocational rehabilitation may benefit from using the MSWDQ-23 to predict the current work outcomes and future employment expectations.

What Matters in Education: A Decomposition of Educational Outcomes with Multiple Measures

ERIC Educational Resources Information Center

Li, Jinjing; Miranti, Riyana; Vidyattama, Yogi

2017-01-01

Significant variations in educational outcomes across both the spatial and socioeconomic spectra in Australia have been widely debated by policymakers in recent years. This paper examines these variations and decomposes educational outcomes into 3 major input factors: availability of school resources, socioeconomic background, and a latent factor…

An investigation of outcome expectancies as a predictor of treatment response for combat veterans with PTSD: comparison of clinician, self-report, and biological measures.

PubMed

Price, Matthew; Maples, Jessica L; Jovanovic, Tanja; Norrholm, Seth D; Heekin, Mary; Rothbaum, Barbara O

2015-06-01

Outcome expectancy, or the degree to which a client believes that therapy will result in improvement, is related to improved treatment outcomes for multiple disorders. There is a paucity of research investigating this relation in regards to posttraumatic stress disorder (PTSD). Additionally, the bulk of the research on outcome expectancy and treatment outcomes has relied mostly on self-report outcome measures. The relation between outcome expectancy on self-report measures, clinician-rated measures, and two biological indices (fear-potentiated startle and cortisol reactivity) of PTSD symptoms was explored. The sample included combat veterans (N = 116) treated with virtual reality exposure therapy for PTSD. Results supported a negative association between outcome expectancy and both self-report and clinician-rated symptoms at the conclusion of treatment, but outcome expectancy was related to the magnitude of change during treatment for self-report measures only. Outcome expectancy was unrelated to biological measures of treatment response. These findings suggest that outcome expectancy may be related to patient and clinician perceptions of outcomes, but not biological indices of outcome for PTSD. © 2015 Wiley Periodicals, Inc.

Multiple imputation for assessment of exposures to drinking water contaminants: evaluation with the Atrazine Monitoring Program.

PubMed

Jones, Rachael M; Stayner, Leslie T; Demirtas, Hakan

2014-10-01

Drinking water may contain pollutants that harm human health. The frequency of pollutant monitoring may occur quarterly, annually, or less frequently, depending upon the pollutant, the pollutant concentration, and community water system. However, birth and other health outcomes are associated with narrow time-windows of exposure. Infrequent monitoring impedes linkage between water quality and health outcomes for epidemiological analyses. To evaluate the performance of multiple imputation to fill in water quality values between measurements in community water systems (CWSs). The multiple imputation method was implemented in a simulated setting using data from the Atrazine Monitoring Program (AMP, 2006-2009 in five Midwestern states). Values were deleted from the AMP data to leave one measurement per month. Four patterns reflecting drinking water monitoring regulations were used to delete months of data in each CWS: three patterns were missing at random and one pattern was missing not at random. Synthetic health outcome data were created using a linear and a Poisson exposure-response relationship with five levels of hypothesized association, respectively. The multiple imputation method was evaluated by comparing the exposure-response relationships estimated based on multiply imputed data with the hypothesized association. The four patterns deleted 65-92% months of atrazine observations in AMP data. Even with these high rates of missing information, our procedure was able to recover most of the missing information when the synthetic health outcome was included for missing at random patterns and for missing not at random patterns with low-to-moderate exposure-response relationships. Multiple imputation appears to be an effective method for filling in water quality values between measurements. Copyright © 2014 Elsevier Inc. All rights reserved.

Outcome measures for clinical rehabilitation trials: impairment, function, quality of life, or value?

PubMed

Wade, Derick T

2003-10-01

Choosing outcome measures in rehabilitation research depends on the standard research skills of clear thinking, attention to detail, and minimizing the amount of data collected. In rehabilitation, outcome is more difficult to measure because (1) usually several outcomes are relevant, (2) relevant outcomes are affected by multiple factors in addition to treatment, and (3) even good measures rarely reflect the specific interest of any individual patient or member of the rehabilitation team, leading to some dissent. Measurement of general quality of life is not possible because there is little agreement as to the nature of the construct; moreover, measurement of relevant aspects of quality of life would probably give similar results. Cost in terms of resources can be estimated, but there is no validated or even widely accepted method of relating this to benefit in a fair, open, and rational way. Outcome is best measured at the level of behavior (activities), with other measures being used to aid interpretation.

Statistical approaches to assessing single and multiple outcome measures in dry eye therapy and diagnosis.

PubMed

Tomlinson, Alan; Hair, Mario; McFadyen, Angus

2013-10-01

Dry eye is a multifactorial disease which would require a broad spectrum of test measures in the monitoring of its treatment and diagnosis. However, studies have typically reported improvements in individual measures with treatment. Alternative approaches involve multiple, combined outcomes being assessed by different statistical analyses. In order to assess the effect of various statistical approaches to the use of single and combined test measures in dry eye, this review reanalyzed measures from two previous studies (osmolarity, evaporation, tear turnover rate, and lipid film quality). These analyses assessed the measures as single variables within groups, pre- and post-intervention with a lubricant supplement, by creating combinations of these variables and by validating these combinations with the combined sample of data from all groups of dry eye subjects. The effectiveness of single measures and combinations in diagnosis of dry eye was also considered. Copyright © 2013. Published by Elsevier Inc.

RACE AS LIVED EXPERIENCE

PubMed Central

Garcia, John A.; Sanchez, Gabriel R.; Sanchez-Youngman, Shannon; Vargas, Edward D.; Ybarra, Vickie D.

2015-01-01

A growing body of social science research has sought to conceptualize race as a multidimensional concept in which context, societal relations, and institutional dynamics are key components. Utilizing a specially designed survey, we develop and use multiple measures of race (skin color, ascribed race, and discrimination experiences) to capture race as “lived experience” and assess their impact on Latinos’ self-rated health status. We model these measures of race as a lived experience to test the explanatory power of race, both independently and as an integrated scale with categorical regression, scaling, and dimensional analyses. Our analyses show that our multiple measures of race have significant and negative effects on Latinos’ self-reported health. Skin color is a dominant factor that impacts self-reported health both directly and indirectly. We then advocate for the utilization of multiple measures of race, adding to those used in our analysis, and their application to other health and social outcomes. Our analysis provides important contributions across a wide range of health, illness, social, and political outcomes for communities of color. PMID:26681972

Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. Clinical Outcomes in Routine Evaluation-Outcome Measures.

PubMed

Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G

2001-04-01

To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.

Convergent Evidence Scaling for Multiple Assessment Indicators: Conceptual Issues, Applications, and Technical Challenges

ERIC Educational Resources Information Center

Busse, R. T.; Elliott, Stephen N.; Kratochwill, Thomas R.

2010-01-01

The purpose of this article is to present Convergent Evidence Scaling (CES) as an emergent method for combining data from multiple assessment indicators. The CES method combines single-case assessment data by converging data gathered across multiple persons, settings, or measures, thereby providing an overall criterion-referenced outcome on which…

Design-Comparable Effect Sizes in Multiple Baseline Designs: A General Modeling Framework

ERIC Educational Resources Information Center

Pustejovsky, James E.; Hedges, Larry V.; Shadish, William R.

2014-01-01

In single-case research, the multiple baseline design is a widely used approach for evaluating the effects of interventions on individuals. Multiple baseline designs involve repeated measurement of outcomes over time and the controlled introduction of a treatment at different times for different individuals. This article outlines a general…

Outcome science in practice: an overview and initial experience at the Vanderbilt Spine Center.

PubMed

McGirt, Matthew J; Speroff, Theodore; Godil, Saniya Siraj; Cheng, Joseph S; Selden, Nathan R; Asher, Anthony L

2013-01-01

In terms of policy, research, quality improvement, and practice-based learning, there are essential principles--namely, quality, effectiveness, and value of care--needed to navigate changes in the current and future US health care environment. Patient-centered outcome measurement lies at the core of all 3 principles. Multiple measures of disease-specific disability, generic health-related quality of life, and preference-based health state have been introduced to quantify disease impact and define effectiveness of care. This paper reviews the basic principles of patient outcome measurement and commonly used outcome instruments. The authors provide examples of how utilization of outcome measurement tools in everyday neurosurgical practice can facilitate practice-based learning, quality improvement, and real-world comparative effectiveness research, as well as promote the value of neurosurgical care.

Standardized Reporting of the Eczema Area and Severity Index (EASI) and the Patient-Oriented Eczema Measure (POEM): A Recommendation by the Harmonising Outcome Measures for Eczema (HOME) Initiative.

PubMed

Grinich, E; Schmitt, J; Küster, D; Spuls, P I; Williams, H C; Chalmers, J R; Thomas, K S; Apfelbacher, C; Prinsen, C A C; Furue, M; Stuart, B; Carter, B; Simpson, E

2018-05-10

Several organizations from multiple fields of medicine are setting standards for clinical research including protocol development, 1 harmonization of outcome reporting, 2 statistical analysis, 3 quality assessment 4 and reporting of findings. 1 Clinical research standardization facilitates the interpretation and synthesis of data, increases the usability of trial results for guideline groups and shared decision-making, and reduces selective outcome reporting bias. The mission of the Harmonising Outcome Measures for Eczema (HOME) initiative is to establish an agreed-upon core set of outcomes to be measured and reported in all clinical trials of atopic dermatitis (AD). This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

PubMed

Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

2015-04-15

Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

Comparative Study of Outcome Measures and Analysis Methods for Traumatic Brain Injury Trials

PubMed Central

Alali, Aziz S.; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B.

2015-01-01

Abstract Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a “super” dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data. PMID:25317951

Financial burden is associated with worse health-related quality of life in adults with multiple endocrine neoplasia type 1.

PubMed

Peipert, Benjamin J; Goswami, Sneha; Helenowski, Irene; Yount, Susan E; Sturgeon, Cord

2017-12-01

Health-related quality of life and financial burden among patients with multiple endocrine neoplasia type 1 is poorly described. It is not known how financial burden influences health-related quality of life in this population. We hypothesized that the financial burden attributable to multiple endocrine neoplasia type 1 is associated with worse health-related quality of life. United States adults (≥18 years) with multiple endocrine neoplasia type 1 were recruited from the AMENSupport MEN online support group. Patient demographics, clinical characteristics, and financial burden were assessed via an online survey. The instrument Patient-Reported Outcomes Measurement Information System 29-item profile measure was used to assess health-related quality of life. Multivariable linear regression was used to identify significant variables in each Patient-Reported Outcomes Measurement Information System domain. Out of 1,378 members in AMENSupport, our survey link was accessed 449 times (33%). Of 153 US respondents who completed our survey, 84% reported financial burden attributable to multiple endocrine neoplasia type 1. The degree of financial burden had a linear relationship with worse health-related quality of life across all Patient-Reported Outcomes Measurement Information System domains (r = 0.36-0.55, P < .001); 63% reported experiencing ≥1 negative financial event(s). Borrowing money from friends/family (30%), unemployment (13%), and spending >$100/month out-of-pocket on prescription medications (46%) were associated consistently with impaired health-related quality of life (ß = 3.75-6.77, P < .05). Respondents were 3- and 34-times more likely to be unemployed and declare bankruptcy than the US population, respectively. This study characterizes the financial burden in patients with multiple endocrine neoplasia type 1. Individuals with multiple endocrine neoplasia type 1 report a high degree of financial burden, negative financial events, and unemployment. Each of these factors was associated with worse health-related quality of life. Copyright © 2017 Elsevier Inc. All rights reserved.

Resilience Mediates the Longitudinal Relationships Between Social Support and Mental Health Outcomes in Multiple Sclerosis.

PubMed

Koelmel, Emily; Hughes, Abbey J; Alschuler, Kevin N; Ehde, Dawn M

2017-06-01

To investigate the longitudinal relationships between social support and subsequent mental health outcomes in individuals with multiple sclerosis (MS), and to examine resilience as a mediator between social support and subsequent mental health outcomes in this population. Observational, longitudinal cohort study. Participants were assessed at 4 time points over 12 months in the context of a previously reported randomized controlled trial. Telephone-based measures administered to community-based participants. Individuals (N=163) with MS and 1 or more of the following symptoms: depression, fatigue, and pain. Not applicable. Mental health outcomes included (1) depressive symptomatology, assessed using the Patient Health Questionnaire-9; (2) anxious symptomatology, assessed using the short form of the Emotional Distress-Anxiety Scale from the Patient-Reported Outcomes Measurement Information System; and (3) general mental health status, assessed using the Mental Component Summary score from the Short Form-8 Health Survey. Resilience was assessed using the Connor-Davidson Resilience Scale. At any given time, social support from significant others, family members, and friends was significantly associated with subsequent mental health outcomes for all 3 measures assessed (all P values <.05). Resilience measured concomitantly with social support significantly mediated the relationships between social support and subsequent mental health outcomes. After controlling for resilience, most of the direct relationships between social support and mental health outcomes were no longer significant. There are significant longitudinal relationships between social support, resilience, and mental health outcomes for people with MS. Given the mediating role of resilience in supporting better mental health outcomes, future clinical research and practice may benefit from an emphasis on resilience-focused psychological interventions. Copyright © 2016 American Congress of Rehabilitation Medicine. All rights reserved.

Long-term safety and real-world effectiveness of fingolimod in relapsing multiple sclerosis

PubMed Central

Druart, Charlotte; El Sankari, Souraya; van Pesch, Vincent

2018-01-01

With a growing number of disease-modifying therapies becoming available for relapsing multiple sclerosis, there is an important need to gather real-world evidence data regarding long-term treatment effectiveness and safety in unselected patient populations. Although not providing as high a level of evidence as randomized controlled trials, and prone to bias, real-world studies from observational studies or registries nevertheless provide crucial information on real-world outcomes of a given therapy. In addition, evaluation of treatment satisfaction and impact on quality of life are increasingly regarded as complementary outcome measures. Fingolimod was the first oral disease-modifying therapy approved for relapsing multiple sclerosis. This review aims to summarize current knowledge on the long-term effectiveness and safety outcomes of multiple sclerosis patients on fingolimod. Impact on treatment satisfaction and quality of life will be discussed according to available data. PMID:29317850

Imaging outcomes for trials of remyelination in multiple sclerosis

PubMed Central

Mallik, Shahrukh; Samson, Rebecca S; Wheeler-Kingshott, Claudia A M; Miller, David H

2014-01-01

Trials of potential neuroreparative agents are becoming more important in the spectrum of multiple sclerosis research. Appropriate imaging outcomes are required that are feasible from a time and practicality point of view, as well as being sensitive and specific to myelin, while also being reproducible and clinically meaningful. Conventional MRI sequences have limited specificity for myelination. We evaluate the imaging modalities which are potentially more specific to myelin content in vivo, such as magnetisation transfer ratio (MTR), restricted proton fraction f (from quantitative magnetisation transfer measurements), myelin water fraction and diffusion tensor imaging (DTI) metrics, in addition to positron emission tomography (PET) imaging. Although most imaging applications to date have focused on the brain, we also consider measures with the potential to detect remyelination in the spinal cord and in the optic nerve. At present, MTR and DTI measures probably offer the most realistic and feasible outcome measures for such trials, especially in the brain. However, no one measure currently demonstrates sufficiently high sensitivity or specificity to myelin, or correlation with clinical features, and it should be useful to employ more than one outcome to maximise understanding and interpretation of findings with these sequences. PET may be less feasible for current and near-future trials, but is a promising technique because of its specificity. In the optic nerve, visual evoked potentials can indicate demyelination and should be correlated with an imaging outcome (such as optic nerve MTR), as well as clinical measures. PMID:24769473

Validation of a Quantitative Single-Subject Based Evaluation for Rehabilitation-Induced Improvement Assessment.

PubMed

Gandolla, Marta; Molteni, Franco; Ward, Nick S; Guanziroli, Eleonora; Ferrigno, Giancarlo; Pedrocchi, Alessandra

2015-11-01

The foreseen outcome of a rehabilitation treatment is a stable improvement on the functional outcomes, which can be longitudinally assessed through multiple measures to help clinicians in functional evaluation. In this study, we propose an automatic comprehensive method of combining multiple measures in order to assess a functional improvement. As test-bed, a functional electrical stimulation based treatment for foot drop correction performed with chronic post-stroke participants is presented. Patients were assessed on five relevant outcome measures before, after intervention, and at a follow-up time-point. A novel algorithm based on variables minimum detectable change is proposed and implemented in a custom-made software, combining the outcome measures to obtain a unique parameter: capacity score. The difference between capacity scores at different timing is three holded to obtain improvement evaluation. Ten clinicians evaluated patients on the Improvement Clinical Global Impression scale. Eleven patients underwent the treatment, and five resulted to achieve a stable functional improvement, as assessed by the proposed algorithm. A statistically significant agreement between intra-clinicians and algorithm-clinicians evaluations was demonstrated. The proposed method evaluates functional improvement on a single-subject yes/no base by merging different measures (e.g., kinematic, muscular) and it is validated against clinical evaluation.

The Cultural Adaptability of Intermediate Measures of Functional Outcome in Schizophrenia*

PubMed Central

Rubin, Maureen; Fredrick, Megan M.; Mintz, Jim; Nuechterlein, Keith H.; Schooler, Nina R.; Jaeger, Judith; Peters, Nancy M.; Buller, Raimund; Marder, Stephen R.; Dube, Sanjay

2012-01-01

The Measurement and Treatment Research to Improve Cognition in Schizophrenia initiative was designed to encourage the development of cognitive enhancing agents for schizophrenia. For a medication to receive this indication, regulatory agencies require evidence of improvement in both cognition and functional outcome. Because medication trials are conducted across multiple countries, we examined ratings of the cross-cultural adaptability of 4 intermediate measures of functional outcome (Independent Living Scales, UCSD Performance-based Skills Assessment, Test of Adaptive Behavior in Schizophrenia, Cognitive Assessment Interview [CAI]) made by experienced clinical researchers at 31 sites in 8 countries. English-speaking research staff familiar with conducting medication trials rated the extent to which each subscale of each intermediate measure could be applied to their culture and to subgroups within their culture based on gender, geographic region, ethnicity, and socioeconomic status on the Cultural Adaptation Rating Scale. Ratings suggested that the CAI would be easiest to adapt across cultures. However, in a recent study, the CAI was found to have weaker psychometric properties than some of the other measures. Problems were identified for specific subscales on all the performance-based assessments across multiple countries. India, China, and Mexico presented the greatest challenges in adaptation. For international clinical trials, it would be important to use the measures that are most adaptable, to adapt subscales that are problematic for specific countries or regions, or to develop a battery composed of the subscales from different instruments that may be most acceptable across multiple cultures with minimal adaptation. PMID:21134973

Neurocognition and community outcome in schizophrenia: long-term predictive validity.

PubMed

Fujii, Daryl E; Wylie, A Michael

2003-02-01

The present study examined the predictive validity of neuropsychological measures to functional outcome in 26 schizophrenic patients 15-plus year post-testing. Outcome measures included score on the Resource Associated Functional Level Scale (RAFLS), number of state hospital admissions, and total duration of state hospital inpatient stay. Results of several stepwise multiple regressions revealed that verbal memory significantly predicted RAFLS score, accounting for nearly half of the variance. Trails B significantly predicted duration of state hospital inpatient status. Discussion focused on the utility of these measures for clinicians and system planners. Copyright 2002 Elsevier Science B.V.

Prognosis of the individual course of disease: the elements of time, heterogeneity and precision.

PubMed

Daumer, Martin; Neuhaus, Anneke; Herbert, Joseph; Ebers, George

2009-12-01

There is no gold standard in monitoring disease activity for clinical trials in multiple sclerosis. Various outcome measures, including relapses, disability and magnetic resonance imaging (MRI) measures have been used to demonstrate the efficacy of the different available therapies for multiple sclerosis. Recently, the potential limitations of these measures have received increasing attention, and these have stimulated research into more appropriate and sensitive outcome measures for clinical trials. For example, it has been shown that widely-used MRI measures add little, if any, independent information to that provided by more clinically relevant measures such as relapses and disability. Similarly, the Expanded Disability status Scale (EDSS), which is the most widely-used measure of disability related to multiple sclerosis, is insufficiently sensitive to detect robust changes in disability over the timeframes usually used in clinical trials. An alternative to the EDSS is the Multiple Sclerosis Severity Score (MSSS), a severity scale which relates clinical disability to disease duration. The MSSS was originally developed from a database of nearly ten thousand patients from eleven European countries and Australia and has since been reproduced in an independent dataset of 1134 patients from the placebo arms of randomised clinical trials. Based on the MSSS score, disease severity can be defined, which shows stability over time and may provide evidence-based decision support for patient management. Another alternative to measure disability is the objective quantification of physical activity. There is evidence that recent developments in pervasive computing using tiny accelerometers may have the potential to increase the reliability and precision of motor assessment, especially in the mid-range of the EDSS. The outcome measures discussed have potential use as online tools for evidence-based decision support which are increasingly being used in medical research and clinical decision-making. Copyright 2009 Elsevier Ltd. All rights reserved.

Do Wellness Tourists Get Well? An Observational Study of Multiple Dimensions of Health and Well-Being After a Week-Long Retreat

PubMed Central

Elliott, Fiona; Oates, Liza; Schembri, Adrian; Mantri, Nitin

2017-01-01

Abstract Background: Wellness retreats use many complementary and alternative therapies within a holistic residential setting, yet few studies have evaluated the effect of retreat experiences on multiple dimensions of health and well-being, and no published studies have reported health outcomes in wellness tourists. Objectives: To assess the effect of a week-long wellness-retreat experience in wellness tourists. Design: A longitudinal observational study with outcomes assessed upon arrival and departure and 6 weeks after the retreat. Setting: A rural health retreat in Queensland, Australia. Interventions: A holistic, 1-week, residential, retreat experience that included many educational, therapeutic, and leisure activities and an organic, mostly plant-based diet. Outcome measures: Multiple outcome measures were performed upon arrival and departure and 6 weeks after the retreat. These included anthropometric measures, urinary pesticide metabolites, a food and health symptom questionnaire, the Five Factor Wellness Inventory, the General Self Efficacy questionnaire, the Pittsburgh Insomnia Rating Scale, the Depression Anxiety Stress Scale, the Profile of Mood States, and the Cogstate cognitive function test battery. Results: Statistically significant improvements (p < 0.05) were seen in almost all measures (n = 37) after 1 week and were sustained at 6 weeks (n = 17). There were statistically significant improvements (p < 0.001) in all anthropometric measures after 1 week, with reductions in abdominal girth (2.7 cm), weight (1.6 kg), and average systolic and diastolic pressure (−16.1 mmHg and −9.3 mmHg, respectively). Statistically significant improvements (p < 0.05) were also seen in psychological and health symptom measures. Urinary pesticide metabolites were detected in pooled urine samples before the retreat and were undetectable after the retreat. Conclusion: Retreat experiences can lead to substantial improvements in multiple dimensions of health and well-being that are maintained for 6 weeks. Further research that includes objective biomarkers and economic measures in different populations is required to determine the mechanisms of these effects and assess the value and relevance of retreat experiences to clinicians and health insurers. PMID:28068147

Measuring outcomes for neurological disorders: a review of disease-specific health status instruments for three degenerative neurological conditions.

PubMed

Heffernan, Catherine; Jenkinson, Crispin

2005-06-01

Health-related quality-of-life measures have been increasingly used in research into neurological disorders in recent years. The aim of this paper is to provide an objective appraisal of the evidence in regard to disease-specific quality-of-life measures used in research on health interventions for three degenerative neurological disorders: multiple sclerosis, motor neurone disease/amyotrophic lateral sclerosis and Parkinson's disease. A comprehensive search strategy was developed to include nine relevant electronic databases. Only studies pertaining to patient-based outcome measurements in multiple sclerosis, motor neurone disease and Parkinson's disease were included. We identified 76 eligible studies. As studies consisted of descriptive and cross-sectional survey study designs, results were reported qualitatively rather than in the form of a meta-analysis. Four disease-specific measures were found for Parkinson's disease, 11 for multiple sclerosis and one for motor neurone disease. We conclude that health-related quality-of-life measures are useful in assessing the impact of treatments and interventions for neurological disorders. However, further research is needed on the development of instruments using psychometric methods and on the validation, utilization and responsiveness of instruments to change.

Multiple Aspects of High School Students' Strategic Processing on Reading Outcomes: The Role of Quantity, Quality, and Conjunctive Strategy Use

ERIC Educational Resources Information Center

Parkinson, Meghan M.; Dinsmore, Daniel L.

2018-01-01

Background: While the literature on strategy use is relatively mature, measures of strategy use overwhelmingly measure only one aspect of that use, frequency, when relating that strategy use to performance outcomes. While this might be one important attribute of strategy use, there is increasing evidence that quality and conditional use of…

Validation of an Instrument for Measuring Students' Understanding of Interdisciplinary Science in Grades 4-8 over Multiple Semesters: A Rasch Measurement Study

ERIC Educational Resources Information Center

Yang, Yang; He, Peng; Liu, Xiufeng

2018-01-01

So far, not enough effort has been invested in developing reliable, valid, and engaging assessments in school science, especially assessment of interdisciplinary science based on the new Next Generation Science Standards (NGSS). Furthermore, previous tools rely mostly on multiple-choice items and evaluation of student outcome is linked only to…

Prediction of Autism at 3 Years from Behavioural and Developmental Measures in High-Risk Infants: A Longitudinal Cross-Domain Classifier Analysis

ERIC Educational Resources Information Center

Bussu, G.; Jones, E. J. H.; Charman, T.; Johnson, M. H.; Buitelaar, J. K.; Baron-Cohen, S.; Bedford, R.; Bolton, P.; Blasi, A.; Chandler, S.; Cheung, C.; Davies, K.; Elsabbagh, M.; Fernandes, J.; Gammer, I.; Garwood, H.; Gliga, T.; Guiraud, J.; Hudry, K.; Liew, M.; Lloyd-Fox, S.; Maris, H.; O'Hara, L.; Pasco, G.; Pickles, A.; Ribeiro, H.; Salomone, E.; Tucker, L.; Volein, A.

2018-01-01

We integrated multiple behavioural and developmental measures from multiple time-points using machine learning to improve early prediction of individual Autism Spectrum Disorder (ASD) outcome. We examined Mullen Scales of Early Learning, Vineland Adaptive Behavior Scales, and early ASD symptoms between 8 and 36 months in high-risk siblings (HR; n…

DEMONSTRATION OF LOW COST, LOW BURDEN EXPOSURE MONITORING STRATEGIES FOR USE IN LONGITUDINAL COHORT STUDIES

EPA Science Inventory

A large longitudinal cohort study designed to evaluate the association between children's exposures to environmental agents and health outcomes presents many challenges for exposure monitoring. Exposure of the child must be measured for multiple chemicals through multiple path...

How is the sustainability of chronic disease health programmes empirically measured in hospital and related healthcare services?-a scoping review.

PubMed

Francis, Linda; Dunt, David; Cadilhac, Dominique A

2016-05-31

Programmes to address chronic disease are a focus of governments worldwide. Despite growth in 'implementation science', there is a paucity of knowledge regarding the best means to measure sustainability. The aim of this review was to summarise current practice for measuring sustainability outcomes of chronic disease health programmes, providing guidance for programme planners and future directions for the academic field. A scoping review of the literature spanning 1985-2015 was conducted using MEDLINE, CINAHL, PsychINFO and The Cochrane Library limited to English language and adults. Main search terms included chronic disease, acute care, sustainability, institutionalisation and health planning. A descriptive synthesis was required. Settings included primary care, hospitals, mental health centres and community health. Programmes included preventing or managing chronic conditions including diabetes, heart disease, depression, respiratory disease, cancer, obesity, dental hygiene and multiple chronic diseases. Outcome measures included clarifying a sustainability definition, types of methodologies used, timelines for assessment, criteria levels to determine outcomes and how methodology varies between intervention types. Among 153 abstracts retrieved, 87 were retained for full article review and 42 included in the qualitative synthesis. Five definitions for sustainability outcome were identified with 'maintenance of programme activities' most frequent. Achieving sustainability was dependent on inter-relationships between various organisational and social contexts supporting a broad scale approach to evaluation. An increasing trend in use of mixed methods designs over multiple time points to determine sustainability outcomes was found. Despite the importance and investment in chronic disease programmes, few studies are undertaken to measure sustainability. Methods to evaluate sustainability are diverse with some emerging patterns in measurement found. Use of mixed methods approaches over multiple time points may serve to better guide measurement of sustainability. Consensus on aspects of standardised measurement would promote the future possibility of meta-analytic syntheses. 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/

Cost-effectiveness with multiple outcomes.

PubMed

Bjørner, Jakob; Keiding, Hans

2004-12-01

In a large number of situations, activities in health care have to be measured in terms of outcome and cost. However, the cases where outcome is fully captured by a single measure are rather few, so that one uses some index for outcome, computed by weighing together several outcome measures using subjective and somewhat arbitrary weights. In the paper we propose an approach to cost-effectiveness analysis where such artificial aggregation is avoided. This is achieved by assigning to each activity the weights which are the most favourable in a comparison with the other options available, so that activities which have a poor score in this method are guaranteed to be inferior. The method corresponds to applying Data envelopment analysis, known from the theory of productivity, to the context of health economic evaluations. The method is applied to an analysis of the cost-effectiveness of alternative health plans using data from the Medical Outcome Study (JAMA 1996; 276: 1039-1047), where outcome is measured as improvement in mental and physical health. 2004 John Wiley & Sons, Ltd.

Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial.

PubMed

Warke, Kim; Al-Smadi, Jamal; Baxter, David; Walsh, Deirdre M; Lowe-Strong, Andrea S

2006-01-01

This study was designed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation (TENS) on chronic low-back pain (LBP) in a multiple sclerosis (MS) population. Ninety participants with probable or definite MS (aged 21 to 78 y) presenting with chronic LBP were recruited and randomized into 3 groups (n=30 per group): (1) low-frequency TENS group (4 Hz, 200 micros); (2) high-frequency TENS group (110 Hz, 200 micros); and (3) placebo TENS. Participants self-applied TENS for 45 minutes, a minimum of twice daily, for 6 weeks. Outcome measures were recorded at weeks 1, 6, 10, and 32. Primary outcome measures included: Visual Analog Scale for average LBP and the McGill Pain Questionnaire. Secondary outcome measures included: Visual Analog Scale for worst and weekly LBP, back and leg spasm; Roland Morris Disability Questionnaire; Barthel Index; Rivermead Mobility Index; Multiple Sclerosis Quality of Life-54 Instrument, and a daily logbook. Data were analyzed blind using parametric and nonparametric tests, as appropriate. Results indicated a statistically significant interactive effect between groups for average LBP (P=0.008); 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied (P>0.05). However, clinically important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods. Although not statistically significant, the observed effects may have implications for the clinical prescription and the use of TENS within this population.

"Hits" (Not "Discussion Posts") Predict Student Success in Online Courses: A Double Cross-Validation Study

ERIC Educational Resources Information Center

Ramos, Cheryl; Yudko, Errol

2008-01-01

The efficacy of individual components of an online course on positive course outcome was examined via stepwise multiple regression analysis. Outcome was measured as the student's total score on all exams given during the course. The predictors were page hits, discussion posts, and discussion reads. The vast majority of the variance of outcome was…

Can we "predict" long-term outcome for ambulatory transcutaneous electrical nerve stimulation in patients with chronic pain?

PubMed

Köke, Albère J; Smeets, Rob J E M; Perez, Roberto S; Kessels, Alphons; Winkens, Bjorn; van Kleef, Maarten; Patijn, Jacob

2015-03-01

Evidence for effectiveness of transcutaneous electrical nerve stimulation (TENS) is still inconclusive. As heterogeneity of chronic pain patients might be an important factor for this lack of efficacy, identifying factors for a successful long-term outcome is of great importance. A prospective study was performed to identify variables with potential predictive value for 2 outcome measures on long term (6 months); (1) continuation of TENS, and (2) a minimally clinical important pain reduction of ≥ 33%. At baseline, a set of risk factors including pain-related variables, psychological factors, and disability was measured. In a multiple logistic regression analysis, higher patient's expectations, neuropathic pain, no severe pain (< 80 mm visual analogue scale [VAS]) were independently related to long-term continuation of TENS. For the outcome "minimally clinical important pain reduction," the multiple logistic regression analysis indicated that no multisited pain (> 2 pain locations) and intermittent pain were positively and independently associated with a minimally clinical important pain reduction of ≥ 33%. The results showed that factors associated with a successful outcome in the long term are dependent on definition of successful outcome. © 2014 World Institute of Pain.

Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis

PubMed Central

Benedict, Ralph HB; DeLuca, John; Phillips, Glenn; LaRocca, Nicholas; Hudson, Lynn D; Rudick, Richard

2017-01-01

Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude. PMID:28206827

Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis.

PubMed

Benedict, Ralph Hb; DeLuca, John; Phillips, Glenn; LaRocca, Nicholas; Hudson, Lynn D; Rudick, Richard

2017-04-01

Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude.

Improving hand functional use in subjects with multiple sclerosis using a musical keyboard: a randomized controlled trial.

PubMed

Gatti, Roberto; Tettamanti, Andrea; Lambiase, Simone; Rossi, Paolo; Comola, Mauro

2015-06-01

Playing an instrument implies neuroplasticity in different cerebral regions. This phenomenon has been described in subjects with stroke, suggesting that it could play a role in hand rehabilitation. The aim of this study is to analyse the effectiveness of playing a musical keyboard in improving hand function in subjects with multiple sclerosis. Nineteen hospitalized subjects were randomized in two groups: nine played a turned-on musical keyboard by sequences of fingers movements (audio feedback present) and 10 performed the same exercises on a turned-off musical keyboard (audio feedback absent). Training duration was half an hour per day for 15 days. Primary outcome was the perceived hand functional use measured by ABILHAND Questionnaire. Secondary outcomes were hand dexterity, measured by Nine-Hole Peg Test, and hand strength, measured by Jamar and Pinch dynamometers. Two-way analysis of variance was used for data analysis. The interaction time × group was significant (p = 0.003) for ABILHAND Questionnaire in favour of experimental group (mean between-group difference 0.99 logit [IC95%: 0.44; 1.54]). The two groups showed a significant time effect for all outcomes except for Jamar measure. Playing a musical keyboard seems a valid method to train the functional use of hands in subjects with multiple sclerosis. Copyright © 2014 John Wiley & Sons, Ltd.

Low Back Pain Subgroups using Fear-Avoidance Model Measures: Results of a Cluster Analysis

PubMed Central

Beneciuk, Jason M.; Robinson, Michael E.; George, Steven Z.

2012-01-01

Objectives The purpose of this secondary analysis was to test the hypothesis that an empirically derived psychological subgrouping scheme based on multiple Fear-Avoidance Model (FAM) constructs would provide additional capabilities for clinical outcomes in comparison to a single FAM construct. Methods Patients (n = 108) with acute or sub-acute low back pain (LBP) enrolled in a clinical trial comparing behavioral physical therapy interventions to classification based physical therapy completed baseline questionnaires for pain catastrophizing (PCS), fear-avoidance beliefs (FABQ-PA, FABQ-W), and patient-specific fear (FDAQ). Clinical outcomes were pain intensity and disability measured at baseline, 4-weeks, and 6-months. A hierarchical agglomerative cluster analysis was used to create distinct cluster profiles among FAM measures and discriminant analysis was used to interpret clusters. Changes in clinical outcomes were investigated with repeated measures ANOVA and differences in results based on cluster membership were compared to FABQ-PA subgrouping used in the original trial. Results Three distinct FAM subgroups (Low Risk, High Specific Fear, and High Fear & Catastrophizing) emerged from cluster analysis. Subgroups differed on baseline pain and disability (p’s<.01) with the High Fear & Catastrophizing subgroup associated with greater pain than the Low Risk subgroup (p<.01) and the greatest disability (p’s<.05). Subgroup × time interactions were detected for both pain and disability (p’s<.05) with the High Fear & Catastrophizing subgroup reporting greater changes in pain and disability than other subgroups (p’s<.05). In contrast, FABQ-PA subgroups used in the original trial were not associated with interactions for clinical outcomes. Discussion These data suggest that subgrouping based on multiple FAM measures may provide additional information on clinical outcomes in comparison to determining subgroup status by FABQ-PA alone. Subgrouping methods for patients with LBP should include multiple psychological factors to further explore if patients can be matched with appropriate interventions. PMID:22510537

A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries.

PubMed

Two, Rebecca; Verjee-Lorenz, Aneesa; Clayson, Darren; Dalal, Mehul; Grotzinger, Kelly; Younossi, Zobair M

2010-01-01

The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.

Minimal Clinically Important Difference: A Review of Outcome Measure Score Interpretation.

PubMed

Engel, Lisa; Beaton, Dorcas E; Touma, Zahi

2018-05-01

Clinicians, researchers, and outcome stakeholders have the crucial, albeit difficult, task of quantifying when a person or group experiences important change or difference on any given outcome measure, often in response to a specific intervention. The minimal clinically important difference (MCID) provides this quantified value of change/difference for a measure. There are many methods for MCID derivation, which can result in multiple values for the same measure. Thus, it is important for potential users of MCID values to be aware of the nuances of MCID development and cautions for interpreting values. This review outlines MCID-related definitions, methods, and guidelines. Copyright © 2018 Elsevier Inc. All rights reserved.

Patient-reported outcomes in child and adolescent mental health services (CAMHS): use of idiographic and standardized measures.

PubMed

Wolpert, Miranda; Ford, Tamsin; Trustam, Emma; Law, Duncan; Deighton, Jessica; Flannery, Halina; Fugard, Andrew J B; Fugard, Rew J B

2012-04-01

There is increasing emphasis on use of patient-reported outcome measures (PROMs) in mental health but little research on the best approach, especially where there are multiple perspectives. To present emerging findings from both standardized and idiographic child-, parent- and clinician-rated outcomes in child and adolescent mental health services (CAMHS) and consider their correlations. Outcomes were collected in CAMHS across the UK. These comprised idiographic measures (goal-based outcomes) and standardized measures (practitioner-rated Children's Global Assessment Scale; child- and parent-rated Strengths and Difficulties Questionnaire). There was reliable positive change from the beginning of treatment to later follow-up according to all informants. Standardized clinician function report was correlated with standardized child difficulty report (r  =  - 0.26), standardized parent report (r  =  - 0.28) and idiographic joint client-determined goals (r  =  0.38) in the expected directions. These results suggest that routine outcome monitoring is feasible, and suggest the possibility of using jointly agreed idiographic measures alongside particular perspectives on outcome as part of a PROMs approach.

Improving Cross-Sector Comparisons: Going Beyond the Health-Related QALY.

PubMed

Brazier, John; Tsuchiya, Aki

2015-12-01

The quality-adjusted life-year (QALY) has become a widely used measure of health outcomes for use in informing decision making in health technology assessment. However, there is growing recognition of outcomes beyond health within the health sector and in related sectors such as social care and public health. This paper presents the advantages and disadvantages of ten possible approaches covering extending the health-related QALY and using well-being and monetary-based methods, in order to address the problem of using multiple outcome measures to inform resource allocation within and between sectors.

Associations between Distal Upper Extremity Job Physical Factors and Psychosocial Measures in a Pooled Study

PubMed Central

2015-01-01

Introduction. There is an increasing body of literature relating musculoskeletal diseases to both job physical exposures and psychosocial outcomes. Relationships between job physical exposure measures and psychosocial factors have not been well examined or quantified. These exploratory analyses evaluate relationships between quantified exposures and psychosocial outcomes. Methods. Individualized quantification of duration, repetition, and force and composite scores of the Strain Index (SI) and the Threshold Limit Value for Hand Activity Level (TLV for HAL) were compared to 10 psychosocial measures. Relationships and predicted probabilities were assessed using ordered logistic regression. Analyses were adjusted for age, BMI, and gender. Results and Discussion. Among 1834 study participants there were multiple statistically significant relationships. In general, as duration, repetition, and force increased, psychosocial factors worsened. However, general health and mental exhaustion improved with increasing job exposures. Depression was most strongly associated with increased repetition, while physical exhaustion was most strongly associated with increased force. SI and TLV for HAL were significantly related to multiple psychosocial factors. These relationships persisted after adjustment for strong confounders. Conclusion. This study quantified multiple associations between job physical exposures and occupational and nonoccupational psychosocial factors. Further research is needed to quantify the impacts on occupational health outcomes. PMID:26557686

Design and baseline data from the Gratitude Research in Acute Coronary Events (GRACE) study

PubMed Central

Huffman, Jeff C.; Beale, Eleanor E.; Beach, Scott R.; Celano, Christopher M.; Belcher, Arianna M.; Moore, Shannon V.; Suarez, Laura; Gandhi, Parul U.; Motiwala, Shweta R.; Gaggin, Hanna; Januzzi, James L.

2015-01-01

Background Positive psychological constructs, especially optimism, have been linked with superior cardiovascular health. However, there has been minimal study of positive constructs in patients with acute coronary syndrome (ACS), despite the prevalence and importance of this condition. Furthermore, few studies have examined multiple positive psychological constructs and multiple cardiac-related outcomes within the same cohort to determine specifically which positive construct may affect a particular cardiac outcome. Materials and methods The Gratitude Research in Acute Coronary Events (GRACE) study examines the association between optimism/gratitude 2 weeks post-ACS and subsequent clinical outcomes. The primary outcome measure is physical activity at 6 months, measured via accelerometer, and key secondary outcome measures include levels of prognostic biomarkers and rates of nonelective cardiac rehospitalization at 6 months. These relationships will be analyzed using multivariate linear regression, controlling for sociodemographic, medical, and negative psychological factors; associations between baseline positive constructs and subsequent rehospitalizations will be assessed via Cox regression. Results Overall, 164 participants enrolled and completed the baseline 2-week assessment; the cohort had a mean age of 61.5 +/− 10.5 years and was 84% men; this was the first ACS for 58% of participants. Conclusion The GRACE study will determine whether optimism and gratitude are prospectively and independently associated with physical activity and other critical outcomes in the 6 months following an ACS. If these constructs are associated with superior outcomes, this may highlight the importance of these constructs as independent prognostic factors post-ACS. PMID:26166171

Design and baseline data from the Gratitude Research in Acute Coronary Events (GRACE) study.

PubMed

Huffman, Jeff C; Beale, Eleanor E; Beach, Scott R; Celano, Christopher M; Belcher, Arianna M; Moore, Shannon V; Suarez, Laura; Gandhi, Parul U; Motiwala, Shweta R; Gaggin, Hanna; Januzzi, James L

2015-09-01

Positive psychological constructs, especially optimism, have been linked with superior cardiovascular health. However, there has been minimal study of positive constructs in patients with acute coronary syndrome (ACS), despite the prevalence and importance of this condition. Furthermore, few studies have examined multiple positive psychological constructs and multiple cardiac-related outcomes within the same cohort to determine specifically which positive construct may affect a particular cardiac outcome. The Gratitude Research in Acute Coronary Events (GRACE) study examines the association between optimism/gratitude 2weeks post-ACS and subsequent clinical outcomes. The primary outcome measure is physical activity at 6months, measured via accelerometer, and key secondary outcome measures include levels of prognostic biomarkers and rates of nonelective cardiac rehospitalization at 6months. These relationships will be analyzed using multivariable linear regression, controlling for sociodemographic, medical, and negative psychological factors; associations between baseline positive constructs and subsequent rehospitalizations will be assessed via Cox regression. Overall, 164 participants enrolled and completed the baseline 2-week assessment; the cohort had a mean age of 61.5+/?10.5years and was 84% men; this was the first ACS for 58% of participants. The GRACE study will determine whether optimism and gratitude are prospectively and independently associated with physical activity and other critical outcomes in the 6months following an ACS. If these constructs are associated with superior outcomes, this may highlight the importance of these constructs as independent prognostic factors post-ACS. Copyright © 2015 Elsevier Inc. All rights reserved.

CONTENT VALIDITY OF SYMPTOM-BASED MEASURES FOR DIABETIC, CHEMOTHERAPY, AND HIV PERIPHERAL NEUROPATHY

PubMed Central

GEWANDTER, JENNIFER S.; BURKE, LAURIE; CAVALETTI, GUIDO; DWORKIN, ROBERT H.; GIBBONS, CHRISTOPHER; GOVER, TONY D.; HERRMANN, DAVID N.; MCARTHUR, JUSTIN C.; MCDERMOTT, MICHAEL P.; RAPPAPORT, BOB A.; REEVE, BRYCE B.; RUSSELL, JAMES W.; SMITH, A. GORDON; SMITH, SHANNON M.; TURK, DENNIS C.; VINIK, AARON I.; FREEMAN, ROY

2017-01-01

Introduction No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures. Methods This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. Results Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included. Conclusions Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. PMID:27447116

Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy.

PubMed

Gewandter, Jennifer S; Burke, Laurie; Cavaletti, Guido; Dworkin, Robert H; Gibbons, Christopher; Gover, Tony D; Herrmann, David N; Mcarthur, Justin C; McDermott, Michael P; Rappaport, Bob A; Reeve, Bryce B; Russell, James W; Smith, A Gordon; Smith, Shannon M; Turk, Dennis C; Vinik, Aaron I; Freeman, Roy

2017-03-01

No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures. This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included. Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. Muscle Nerve 55: 366-372, 2017. © 2016 Wiley Periodicals, Inc.

A latent process model for forecasting multiple time series in environmental public health surveillance.

PubMed

Morrison, Kathryn T; Shaddick, Gavin; Henderson, Sarah B; Buckeridge, David L

2016-08-15

This paper outlines a latent process model for forecasting multiple health outcomes arising from a common environmental exposure. Traditionally, surveillance models in environmental health do not link health outcome measures, such as morbidity or mortality counts, to measures of exposure, such as air pollution. Moreover, different measures of health outcomes are treated as independent, while it is known that they are correlated with one another over time as they arise in part from a common underlying exposure. We propose modelling an environmental exposure as a latent process, and we describe the implementation of such a model within a hierarchical Bayesian framework and its efficient computation using integrated nested Laplace approximations. Through a simulation study, we compare distinct univariate models for each health outcome with a bivariate approach. The bivariate model outperforms the univariate models in bias and coverage of parameter estimation, in forecast accuracy and in computational efficiency. The methods are illustrated with a case study using healthcare utilization and air pollution data from British Columbia, Canada, 2003-2011, where seasonal wildfires produce high levels of air pollution, significantly impacting population health. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Implementation of generalized quantum measurements for unambiguous discrimination of multiple non-orthogonal coherent states.

PubMed

Becerra, F E; Fan, J; Migdall, A

2013-01-01

Generalized quantum measurements implemented to allow for measurement outcomes termed inconclusive can perform perfect discrimination of non-orthogonal states, a task which is impossible using only measurements with definitive outcomes. Here we demonstrate such generalized quantum measurements for unambiguous discrimination of four non-orthogonal coherent states and obtain their quantum mechanical description, the positive-operator valued measure. For practical realizations of this positive-operator valued measure, where noise and realistic imperfections prevent perfect unambiguous discrimination, we show that our experimental implementation outperforms any ideal standard-quantum-limited measurement performing the same non-ideal unambiguous state discrimination task for coherent states with low mean photon numbers.

Multiple Year Extension Program Outcomes & Impacts through Evaluation

ERIC Educational Resources Information Center

Hachfeld, Gary A.; Bau, David B.; Holcomb, C. Robert; Craig, J. William

2013-01-01

Dwindling public funding as well as greater competition for grant dollars create a challenge for Extension. For Extension to remain a financially viable organization, educators have to be able to produce substantive, measurable program outcomes and impacts. Evaluative data can inform program development and delivery, and helps administrators…

Conceptualization and Exploration of Composite Career Anchors: An Analysis of Information Systems Personnel.

ERIC Educational Resources Information Center

Ramakrishna, Hindupur V.; Potosky, Denise

2003-01-01

Information systems professionals (n=163) completed measures of career anchors and outcomes (career/job satisfaction, job performance, perceived advancement prospects); 46% had multiple dominant anchors and these individuals did not have significantly different career outcomes than those with single dominant anchors. (Contains 26 references.) (SK)

Self-Rated Estimates of Multiple Intelligences Based on Approaches to Learning

ERIC Educational Resources Information Center

Bowles, Terry

2008-01-01

To date questionnaires that measure Multiple Intelligences (MIs) have typically not been systematically developed, have poor psychometric properties, and relatively low reliability. The aim of this research was to define the factor structure, and reliability of nine talents which are the behavioural outcomes of MIs, using items representing…

Quality of life after multiple trauma: validation and population norm of the Polytrauma Outcome (POLO) chart.

PubMed

Lefering, R; Tecic, T; Schmidt, Y; Pirente, N; Bouillon, B; Neugebauer, E

2012-08-01

Due to an increasing number of survivors after multiple injuries in Western countries, the health-related quality of life (QoL) is considered to be an important outcome parameter. Up to now, measuring instruments used in this field lacked validity and comparability. Within 6 years, our working group developed a new modular instrument, called the Polytrauma Outcome (POLO) chart. This study documents the validation of the trauma-specific module specifically designed for trauma patients, the Trauma Outcome Profile (TOP). A total of 172 multiply injured patients (mean Injury Severity Score [ISS] 26.7) recruited from eight trauma centres participating in the German Trauma Registry were compared with 166 marginally injured patients (mean ISS 3.9). The mean follow-up was 24.2 and 26.4 months, respectively. The validation questionnaires used were the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), Impact of Event Scale-Revised (IES-R), Social Support Questionnaire (F-SOZU-K-22), Barthel Index of Activities of Daily Living (ADL) and the Short Form Health Survey (SF-36). The internal consistency of the different dimensions of QoL assessed with the TOP was good. Factor analysis provides evidence of the construct validity of the questionnaire. Correlation with external measures gives evidence of criterion validity for the various dimensions of QoL and similar exceedance of proposed cut-off points within TOP and external measures is verified. The TOP module is a reliable and valid instrument to assess health-related QoL in patients with multiple injuries. It can be used stand-alone or as part of the POLO chart together with the Glasgow Outcome Scale (GOS), the EuroQoL and the SF-36 as a regular systematic follow-up instrument.

Movement measurements at home for multiple sclerosis: walking speed measured by a novel ambient measurement system.

PubMed

Smith, Victoria Mj; Varsanik, Jonathan S; Walker, Rachel A; Russo, Andrew W; Patel, Kevin R; Gabel, Wendy; Phillips, Glenn A; Kimmel, Zebadiah M; Klawiter, Eric C

2018-01-01

Gait disturbance is a major contributor to clinical disability in multiple sclerosis (MS). A sensor was developed to assess walking speed at home for people with MS using infrared technology in real-time without the use of wearables. To develop continuous in-home outcome measures to assess gait in adults with MS. Movement measurements were collected continuously for 8 months from six people with MS. Average walking speed and peak walking speed were calculated from movement data, then analyzed for variability over time, by room (location), and over the course of the day. In-home continuous gait outcomes and variability were correlated with standard in-clinic gait outcomes. Measured in-home average walking speed of participants ranged from 0.33 m/s to 0.96 m/s and peak walking speed ranged from 0.89 m/s to 1.51 m/s. Mean total within-participant coefficient of variation for daily average walking speed and peak walking speed were 10.75% and 10.93%, respectively. Average walking speed demonstrated a moderately strong correlation with baseline Timed 25-Foot Walk (r s  = 0.714, P  = 0.111). New non-wearable technology provides reliable and continuous in-home assessment of walking speed.

Relationship between urban sprawl and physical activity, obesity, and morbidity - update and refinement.

PubMed

Ewing, Reid; Meakins, Gail; Hamidi, Shima; Nelson, Arthur C

2014-03-01

This study aims to model multiple health outcomes and behaviors in terms of the updated, refined, and validated county compactness/sprawl measures. Multiple health outcomes and behaviors are modeled using multi-level analysis. After controlling for observed confounding influences, both original and new compactness measures are negatively related to BMI, obesity, heart disease, high blood pressure, and diabetes. Indices are not significantly related to physical activity, perhaps because physical activity is not defined broadly to include active travel to work, shopping, and other destinations. Developing urban and suburban areas in a more compact manner may have some salutary effect on obesity and chronic disease trends. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

PubMed

NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

Multivariate analysis of longitudinal rates of change.

PubMed

Bryan, Matthew; Heagerty, Patrick J

2016-12-10

Longitudinal data allow direct comparison of the change in patient outcomes associated with treatment or exposure. Frequently, several longitudinal measures are collected that either reflect a common underlying health status, or characterize processes that are influenced in a similar way by covariates such as exposure or demographic characteristics. Statistical methods that can combine multivariate response variables into common measures of covariate effects have been proposed in the literature. Current methods for characterizing the relationship between covariates and the rate of change in multivariate outcomes are limited to select models. For example, 'accelerated time' methods have been developed which assume that covariates rescale time in longitudinal models for disease progression. In this manuscript, we detail an alternative multivariate model formulation that directly structures longitudinal rates of change and that permits a common covariate effect across multiple outcomes. We detail maximum likelihood estimation for a multivariate longitudinal mixed model. We show via asymptotic calculations the potential gain in power that may be achieved with a common analysis of multiple outcomes. We apply the proposed methods to the analysis of a trivariate outcome for infant growth and compare rates of change for HIV infected and uninfected infants. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Characterizing the Joint Effect of Diverse Test-Statistic Correlation Structures and Effect Size on False Discovery Rates in a Multiple-Comparison Study of Many Outcome Measures

NASA Technical Reports Server (NTRS)

Feiveson, Alan H.; Ploutz-Snyder, Robert; Fiedler, James

2011-01-01

In their 2009 Annals of Statistics paper, Gavrilov, Benjamini, and Sarkar report the results of a simulation assessing the robustness of their adaptive step-down procedure (GBS) for controlling the false discovery rate (FDR) when normally distributed test statistics are serially correlated. In this study we extend the investigation to the case of multiple comparisons involving correlated non-central t-statistics, in particular when several treatments or time periods are being compared to a control in a repeated-measures design with many dependent outcome measures. In addition, we consider several dependence structures other than serial correlation and illustrate how the FDR depends on the interaction between effect size and the type of correlation structure as indexed by Foerstner s distance metric from an identity. The relationship between the correlation matrix R of the original dependent variables and R, the correlation matrix of associated t-statistics is also studied. In general R depends not only on R, but also on sample size and the signed effect sizes for the multiple comparisons.

From Retention to Satisfaction: New Outcomes for Assessing the Freshman Experience. AIR 1994 Annual Forum Paper.

ERIC Educational Resources Information Center

Sanders, Liz; And Others

To meet accountability challenges from a customer-satisfaction perspective, an urban institution of higher education has developed an integrated approach to studying the freshman year experience in order to develop comprehensive outcomes measures for assessing freshman success. Multiple sources of data (freshman satisfaction survey data,…

A Powerful, Potential Outcomes Method for Estimating Any Estimand across Multiple Groups

ERIC Educational Resources Information Center

Pattanayak, Cassandra W.; Rubin, Donald B.; Zell, Elizabeth R.

2013-01-01

In educational research, outcome measures are often estimated across separate studies or across schools, districts, or other subgroups to assess the overall causal effect of an active treatment versus a control treatment. Students may be partitioned into such strata or blocks by experimental design, or separated into studies within a…

Imaging outcomes for trials of remyelination in multiple sclerosis.

PubMed

Mallik, Shahrukh; Samson, Rebecca S; Wheeler-Kingshott, Claudia A M; Miller, David H

2014-12-01

Trials of potential neuroreparative agents are becoming more important in the spectrum of multiple sclerosis research. Appropriate imaging outcomes are required that are feasible from a time and practicality point of view, as well as being sensitive and specific to myelin, while also being reproducible and clinically meaningful. Conventional MRI sequences have limited specificity for myelination. We evaluate the imaging modalities which are potentially more specific to myelin content in vivo, such as magnetisation transfer ratio (MTR), restricted proton fraction f (from quantitative magnetisation transfer measurements), myelin water fraction and diffusion tensor imaging (DTI) metrics, in addition to positron emission tomography (PET) imaging. Although most imaging applications to date have focused on the brain, we also consider measures with the potential to detect remyelination in the spinal cord and in the optic nerve. At present, MTR and DTI measures probably offer the most realistic and feasible outcome measures for such trials, especially in the brain. However, no one measure currently demonstrates sufficiently high sensitivity or specificity to myelin, or correlation with clinical features, and it should be useful to employ more than one outcome to maximise understanding and interpretation of findings with these sequences. PET may be less feasible for current and near-future trials, but is a promising technique because of its specificity. In the optic nerve, visual evoked potentials can indicate demyelination and should be correlated with an imaging outcome (such as optic nerve MTR), as well as clinical measures. 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.

Multidimensional outcome considerations in assessing the efficacy of medical educational programs.

PubMed

Blumberg, Phyllis

2003-01-01

To be accredited, schools must evaluate the effectiveness of their programs. Educators are looking for specific indicators beyond the traditional measures. Data from multiple methods, including indicators of student performance and of the institutional environment, can be used to determine if educational program goals are met. This article outlines specific ways to consider three types of efficacy outcomes that are consistent with accreditation guidelines: educational, clinical career, and environmental outcomes. Specific measurable outcomes for each of these categories are derived from higher education literature: for example, learning approaches and information acquisition for education; professional behaviors and interpersonal dimensions for clinical career, and scholarship of teaching and teaching itself as a shared and valued activity for environmental outcomes. These outcomes address student assessment and program evaluation. Data from problem-based learning programs illustrate these outcomes. Educators can determine if educational program innovations have met their goals by collecting efficacy outcome data.

The reliability, precision and clinically meaningful change of walking assessments in multiple sclerosis.

PubMed

Learmonth, Yvonne C; Dlugonski, Deirdre D; Pilutti, Lara A; Sandroff, Brian M; Motl, Robert W

2013-11-01

Assessing walking impairment in those with multiple sclerosis (MS) is common, however little is known about the reliability, precision and clinically important change of walking outcomes. The purpose of this study was to determine the reliability, precision and clinically important change of the Timed 25-Foot Walk (T25FW), Six-Minute Walk (6MW), Multiple Sclerosis Walking Scale-12 (MSWS-12) and accelerometry. Data were collected from 82 persons with MS at two time points, six months apart. Analyses were undertaken for the whole sample and stratified based on disability level and usage of walking aids. Intraclass correlation coefficient (ICC) analyses established reliability: standard error of measurement (SEM) and coefficient of variation (CV) determined precision; and minimal detectable change (MDC) defined clinically important change. All outcome measures were reliable with precision and MDC varying between measures in the whole sample: T25FW: ICC=0.991; SEM=1 s; CV=6.2%; MDC=2.7 s (36%), 6MW: ICC=0.959; SEM=32 m; CV=6.2%; MDC=88 m (20%), MSWS-12: ICC=0.927; SEM=8; CV=27%; MDC=22 (53%), accelerometry counts/day: ICC=0.883; SEM=28450; CV=17%; MDC=78860 (52%), accelerometry steps/day: ICC=0.907; SEM=726; CV=16%; MDC=2011 (45%). Variation in these estimates was seen based on disability level and walking aid. The reliability of these outcomes is good and falls within acceptable ranges. Precision and clinically important change estimates provide guidelines for interpreting these outcomes in clinical and research settings.

Analyzing Multiple Outcomes in Clinical Research Using Multivariate Multilevel Models

PubMed Central

Baldwin, Scott A.; Imel, Zac E.; Braithwaite, Scott R.; Atkins, David C.

2014-01-01

Objective Multilevel models have become a standard data analysis approach in intervention research. Although the vast majority of intervention studies involve multiple outcome measures, few studies use multivariate analysis methods. The authors discuss multivariate extensions to the multilevel model that can be used by psychotherapy researchers. Method and Results Using simulated longitudinal treatment data, the authors show how multivariate models extend common univariate growth models and how the multivariate model can be used to examine multivariate hypotheses involving fixed effects (e.g., does the size of the treatment effect differ across outcomes?) and random effects (e.g., is change in one outcome related to change in the other?). An online supplemental appendix provides annotated computer code and simulated example data for implementing a multivariate model. Conclusions Multivariate multilevel models are flexible, powerful models that can enhance clinical research. PMID:24491071

Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.

PubMed

Pukall, Caroline F; Bergeron, Sophie; Brown, Candace; Bachmann, Gloria; Wesselmann, Ursula

2017-08-01

Vulvodynia (idiopathic chronic vulvar pain) is a prevalent condition associated with significant and negative impacts in many areas of function. Despite the increased research interest in vulvodynia in recent years, recommendations for outcome measures for use in clinical trials are missing. The purpose of this paper, therefore, was to provide recommendations for outcome measures for vulvodynia clinical trials so that consistent measures are used across trials to facilitate between-study comparisons and the conduct of large multicenter trials, and to improve measurement of the multiple dimensions of vulvodynia. Given that provoked vestibulodynia (PVD)-characterized by provoked pain localized to the vaginal opening-is the most common subtype of vulvodynia and the current main focus of clinical trials, this paper focused on recommended outcome measures in PVD clinical trials. The framework used to guide the selection of outcome measures was based on the one proposed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). The IMMPACT framework provided a well-suited guideline for outcome measure recommendations in PVD clinical trials. However, given the provoked presentation of PVD and the significant impact it has on sexuality, modifications to some of the IMMPACT recommendations were made and specific additional measures were suggested. Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.

Predictors of postoperative outcomes of cubital tunnel syndrome treatments using multiple logistic regression analysis.

PubMed

Suzuki, Taku; Iwamoto, Takuji; Shizu, Kanae; Suzuki, Katsuji; Yamada, Harumoto; Sato, Kazuki

2017-05-01

This retrospective study was designed to investigate prognostic factors for postoperative outcomes for cubital tunnel syndrome (CubTS) using multiple logistic regression analysis with a large number of patients. Eighty-three patients with CubTS who underwent surgeries were enrolled. The following potential prognostic factors for disease severity were selected according to previous reports: sex, age, type of surgery, disease duration, body mass index, cervical lesion, presence of diabetes mellitus, Workers' Compensation status, preoperative severity, and preoperative electrodiagnostic testing. Postoperative severity of disease was assessed 2 years after surgery by Messina's criteria which is an outcome measure specifically for CubTS. Bivariate analysis was performed to select candidate prognostic factors for multiple linear regression analyses. Multiple logistic regression analysis was conducted to identify the association between postoperative severity and selected prognostic factors. Both bivariate and multiple linear regression analysis revealed only preoperative severity as an independent risk factor for poor prognosis, while other factors did not show any significant association. Although conflicting results exist regarding prognosis of CubTS, this study supports evidence from previous studies and concludes early surgical intervention portends the most favorable prognosis. Copyright © 2017 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

The nature and outcomes of work: a replication and extension of interdisciplinary work-design research.

PubMed

Edwards, J R; Scully, J A; Brtek, M D

2000-12-01

Research into the changing nature of work requires comprehensive models of work design. One such model is the interdisciplinary framework (M. A. Campion, 1988), which integrates 4 work-design approaches (motivational, mechanistic, biological, perceptual-motor) and links each approach to specific outcomes. Unfortunately, studies of this framework have used methods that disregard measurement error, overlook dimensions within each work-design approach, and treat each approach and outcome separately. This study reanalyzes data from M. A. Campion (1988), using structural equation models that incorporate measurement error, specify multiple dimensions for each work-design approach, and examine the work-design approaches and outcomes jointly. Results show that previous studies underestimate relationships between work-design approaches and outcomes and that dimensions within each approach exhibit relationships with outcomes that differ in magnitude and direction.

A Randomized Pilot Study of Naturopathic Medicine in Multiple Sclerosis

PubMed Central

Calabrese, Carlo; Morris, Cynthia; Yadav, Vijayshree; Griffith, Debbie; Frank, Rachel; Oken, Barry S.; Baldauf-Wagner, Sara; Bourdette, Dennis

2008-01-01

Abstract Background Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. Objective To assess quality of life in MS subjects who received interventions designed to “model” the “whole practice” of naturopathy. Design A pilot, randomized, controlled study with a 6-month intervention period. Participants Participants who met criteria for clinically definite MS. Interventions The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. Outcome measures The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. Results Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. Conclusions Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation. PMID:18532899

Distance Education in a Cost Accounting Course: Instruction, Interaction, and Multiple Measures of Learning Outcomes

ERIC Educational Resources Information Center

Chen, Clement C.; Jones, Keith T.; Moreland, Keith

2010-01-01

Students in online and traditional classroom sections of an intermediate-level cost accounting course responded to a survey about their experiences in the course. Specifically, several items related to the instruction and learning outcomes were addressed. Additionally, student examination performance in the two types of sections was compared. The…

An Examination of the Effects of Flow on Learning in a Graduate-Level Introductory Operations Management Course

ERIC Educational Resources Information Center

Klein, Barbara D.; Rossin, Don; Guo, Yi Maggie; Ro, Young K.

2010-01-01

The authors investigated the effects of flow on learning outcomes in a graduate-level operations management course. Flow was assessed through an overall flow score, four dimensions of flow, and three characteristics of flow activities. Learning outcomes were measured objectively through multiple-choice quiz scores and subjectively using measures…

A Systematic Review of Palliative Care Intervention Outcomes and Outcome Measures in Low-Resource Countries.

PubMed

Potts, Maryellen; Cartmell, Kathleen B; Nemeth, Lynne; Bhattacharjee, Gautam; Qanungo, Suparna

2018-05-01

To meet the growing need for palliative care in low-resource countries, palliative care programs should be evidence based and contextually appropriate. This study was conducted to synthesize the current evidence to guide future programmatic and research efforts. This systematic review evaluated palliative care outcome measures, outcomes, and interventions in low-resource countries. After title searches, abstracts and full-text articles were screened for inclusion. Data were extracted to report on intervention models, outcome measures used, and intervention outcomes. Eighteen papers were reviewed, reporting on interventions conducted across nine low-resource countries. These interventions evaluated home-based palliative care models; a community-managed model; palliative care integrated with hospitals, hospices, or HIV clinics; and models focused on patients' self-management. Three studies were randomized controlled trials. Other studies used nonrandomized trials, cohort studies, mixed methods, pre-post test evaluation, cost-accounting evaluation, and cross-sectional surveys. Thirteen studies measured physical outcomes, 10 using multidimensional instruments. Nine studies measured psychological outcomes, eight using multidimensional instruments. Nine studies measured social outcomes, seven using multidimensional instruments. Nine studies measured outcomes across multiple domains. Across outcomes evaluated, results were reported in the direction of benefit associated with palliative care interventions. Many palliative care intervention models exist to serve patients in low-resource countries. Yet, limited high-quality evidence from low-resource countries is available to document intervention outcomes. Rigorous experimental studies and greater measurement of multidimensional aspects of palliative care are needed to advance the science of palliative care in low-resource settings. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Patient-reported outcome measures in reconstructive breast surgery: is there a role for generic measures?

PubMed

Korus, Lisa J; Cypel, Tatiana; Zhong, Toni; Wu, Albert W

2015-03-01

Patient-reported outcomes provide an invaluable tool in the assessment of outcomes in plastic surgery. Traditionally, patient-reported outcomes have consisted of either generic or ad hoc measures; however, more recently, there has been interest in formally constructed and validated questionnaires that are specifically designed for a particular patient population. The purpose of this systematic review was to determine whether generic measures still have a role in the evaluation of breast reconstruction outcomes, given the recent popularity and push for use of specific measures. A systematic review was performed to identify all articles using patient-reported outcomes in the assessment of postmastectomy breast reconstruction. Frequency of use was tabulated and the most frequently used tools were assessed for success of use, using criteria described previously by the Medical Outcomes Trust. To date, the most frequently used measures are still generic measures. The 36-Item Short-Form Health Survey was the most frequently used and most successfully applied showing evidence of responsiveness in multiple settings. Other measures such as the Hospital Anxiety and Depression Scale, the Hopwood Body Image Scale, and the Rosenberg Self-Esteem Scale were able to show responsiveness in certain settings but lacked evidence as universal tools for the assessment of outcomes in reconstructive breast surgery. Despite the recent advent of measures designed specifically to assess patient-reported outcomes in the breast reconstruction population, there still appears to be a role for the use of generic instruments. Many of these tools would benefit from undergoing formal validation in the breast reconstruction population.

Disability and Fatigue Can Be Objectively Measured in Multiple Sclerosis.

PubMed

Motta, Caterina; Palermo, Eduardo; Studer, Valeria; Germanotta, Marco; Germani, Giorgio; Centonze, Diego; Cappa, Paolo; Rossi, Silvia; Rossi, Stefano

2016-01-01

The available clinical outcome measures of disability in multiple sclerosis are not adequately responsive or sensitive. To investigate the feasibility of inertial sensor-based gait analysis in multiple sclerosis. A cross-sectional study of 80 multiple sclerosis patients and 50 healthy controls was performed. Lower-limb kinematics was evaluated by using a commercially available magnetic inertial measurement unit system. Mean and standard deviation of range of motion (mROM, sROM) for each joint of lower limbs were calculated in one minute walking test. A motor performance index (E) defined as the sum of sROMs was proposed. We established two novel observer-independent measures of disability. Hip mROM was extremely sensitive in measuring lower limb motor impairment, being correlated with muscle strength and also altered in patients without clinically detectable disability. On the other hand, E index discriminated patients according to disability, being altered only in patients with moderate and severe disability, regardless of walking speed. It was strongly correlated with fatigue and patient-perceived health status. Inertial sensor-based gait analysis is feasible and can detect clinical and subclinical disability in multiple sclerosis.

Addressing the targeting range of the ABILHAND-56 in relapsing-remitting multiple sclerosis: A mixed methods psychometric study.

PubMed

Cleanthous, Sophie; Strzok, Sara; Pompilus, Farrah; Cano, Stefan; Marquis, Patrick; Cohan, Stanley; Goldman, Myla D; Kresa-Reahl, Kiren; Petrillo, Jennifer; Castrillo-Viguera, Carmen; Cadavid, Diego; Chen, Shih-Yin

2018-01-01

ABILHAND, a manual ability patient-reported outcome instrument originally developed for stroke patients, has been used in multiple sclerosis clinical trials; however, psychometric analyses indicated the measure's limited measurement range and precision in higher-functioning multiple sclerosis patients. The purpose of this study was to identify candidate items to expand the measurement range of the ABILHAND-56, thus improving its ability to detect differences in manual ability in higher-functioning multiple sclerosis patients. A step-wise mixed methods design strategy was used, comprising two waves of patient interviews, a combination of qualitative (concept elicitation and cognitive debriefing) and quantitative (Rasch measurement theory) analytic techniques, and consultation interviews with three clinical neurologists specializing in multiple sclerosis. Original ABILHAND was well understood in this context of use. Eighty-two new manual ability concepts were identified. Draft supplementary items were generated and refined with patient and neurologist input. Rasch measurement theory psychometric analysis indicated supplementary items improved targeting to higher-functioning multiple sclerosis patients and measurement precision. The final pool of Early Multiple Sclerosis Manual Ability items comprises 20 items. The synthesis of qualitative and quantitative methods used in this study improves the ABILHAND content validity to more effectively identify manual ability changes in early multiple sclerosis and potentially help determine treatment effect in higher-functioning patients in clinical trials.

Outcome expectations and physical activity in persons with longstanding multiple sclerosis.

PubMed

Morrison, Janet D; Stuifbergen, Alexa K

2014-06-01

Research suggests that persons with multiple sclerosis (MS) are much less physically active than the general population and that increased physical activity in persons with MS is associated with numerous benefits such as improvements in fatigue, mobility, and quality of life (). Potentially modifiable theory-based determinants of physical activity behavior need to be identified so that researchers may study their effectiveness in randomized clinical trials and clinicians may integrate them into practice to promote physical activity in this population. The purpose of this study was to explore the multidimensional (physical, social, and self-evaluative) outcome expectations for physical activity among persons with longstanding MS. A sample of 369 participants diagnosed with MS for more than 15 years completed surveys to measure multidimensional outcome expectations for exercise, MS functional limitations, and physical activity using two different instruments: one measuring physical activity engagement and the other measuring physical activity capability. Results indicated that MS functional limitation was the strongest predictor of both physical activity engagement and physical activity capability. Physical and social outcome expectations contributed to the model explaining 12% of the variation in physical activity engagement, whereas none of the outcome expectancy dimensions (physical, social, or self-evaluative) contributed to the model explaining variation in physical activity capability. Although analyses of cross-sectional data do not infer causation, these findings suggest that positive physical and social outcome expectations for physical activity are associated with engagement in physical activity as well as being potential sources of motivation for increasing physical activity behavior in individuals living with longstanding MS.

Measuring performance improvement: total organizational commitment or clinical specialization.

PubMed

Caron, Aleece; Jones, Paul; Neuhauser, Duncan; Aron, David C

2004-01-01

Resources for hospitals are limited when they are faced with multiple publicly reported performance measures as tools to assess quality. The leadership in these organizations may choose to focus on 1 or 2 of these outcomes. An alternative approach is that the leadership may commit resources or create conditions that result in improved quality over a broad range of measures. We used aggregated data on mortality, length of stay, and obstetrical outcomes from Greater Cleveland Health Quality Choice data to test these theories. We used Pearson correlation analysis to determine of outcomes were correlated with one another. We used repeated-measures ANOVA to determine if an association existed between outcome and time and outcome and hospital. All of the outcomes across all hospitals demonstrate a trend of overall improvement. Both the Pearson and ANOVA result support the hypothesis for the organization-wide approach to quality improvement. Hospital that make improvements in one clinical area trend to make improvements in others. Hospitals that produce improvements in limited clinical or administrative areas may not have completely adopted CQI into their culture or may not have yet realized the benefits of their organizational commitments, but use some of the concepts to improve quality outcomes.

Examining the role of unmeasured confounding in mediation analysis with genetic and genomic applications.

PubMed

Lutz, Sharon M; Thwing, Annie; Schmiege, Sarah; Kroehl, Miranda; Baker, Christopher D; Starling, Anne P; Hokanson, John E; Ghosh, Debashis

2017-07-19

In mediation analysis if unmeasured confounding is present, the estimates for the direct and mediated effects may be over or under estimated. Most methods for the sensitivity analysis of unmeasured confounding in mediation have focused on the mediator-outcome relationship. The Umediation R package enables the user to simulate unmeasured confounding of the exposure-mediator, exposure-outcome, and mediator-outcome relationships in order to see how the results of the mediation analysis would change in the presence of unmeasured confounding. We apply the Umediation package to the Genetic Epidemiology of Chronic Obstructive Pulmonary Disease (COPDGene) study to examine the role of unmeasured confounding due to population stratification on the effect of a single nucleotide polymorphism (SNP) in the CHRNA5/3/B4 locus on pulmonary function decline as mediated by cigarette smoking. Umediation is a flexible R package that examines the role of unmeasured confounding in mediation analysis allowing for normally distributed or Bernoulli distributed exposures, outcomes, mediators, measured confounders, and unmeasured confounders. Umediation also accommodates multiple measured confounders, multiple unmeasured confounders, and allows for a mediator-exposure interaction on the outcome. Umediation is available as an R package at https://github.com/SharonLutz/Umediation A tutorial on how to install and use the Umediation package is available in the Additional file 1.

Multivariate Analysis of Longitudinal Rates of Change

PubMed Central

Bryan, Matthew; Heagerty, Patrick J.

2016-01-01

Longitudinal data allow direct comparison of the change in patient outcomes associated with treatment or exposure. Frequently, several longitudinal measures are collected that either reflect a common underlying health status, or characterize processes that are influenced in a similar way by covariates such as exposure or demographic characteristics. Statistical methods that can combine multivariate response variables into common measures of covariate effects have been proposed by Roy and Lin [1]; Proust-Lima, Letenneur and Jacqmin-Gadda [2]; and Gray and Brookmeyer [3] among others. Current methods for characterizing the relationship between covariates and the rate of change in multivariate outcomes are limited to select models. For example, Gray and Brookmeyer [3] introduce an “accelerated time” method which assumes that covariates rescale time in longitudinal models for disease progression. In this manuscript we detail an alternative multivariate model formulation that directly structures longitudinal rates of change, and that permits a common covariate effect across multiple outcomes. We detail maximum likelihood estimation for a multivariate longitudinal mixed model. We show via asymptotic calculations the potential gain in power that may be achieved with a common analysis of multiple outcomes. We apply the proposed methods to the analysis of a trivariate outcome for infant growth and compare rates of change for HIV infected and uninfected infants. PMID:27417129

Post-injury personality in the prediction of outcome following severe acquired brain injury.

PubMed

Cattran, Charlotte Jane; Oddy, Michael; Wood, Rodger Llewellyn; Moir, Jane Frances

2011-01-01

The aim of the study was to examine the utility of five measures of non-cognitive neurobehavioural (NCNB) changes that often occur following acquired brain injury, in predicting outcome (measured in terms of participation and social adaptation) at 1-year follow-up. The study employed a longitudinal, correlational design. Multiple regression was employed to investigate the value of five new NCNB measures of social perception, emotional regulation, motivation, impulsivity and disinhibition in the prediction of outcome as measured by the Mayo-Portland Adaptability Inventory (MPAI). Two NCNB measures (motivation and emotional regulation) were found to significantly predict outcome at 1-year follow-up, accounting for 53% of the variance in MPAI total scores. These measures provide a method of quantifying the extent of NCNB changes following brain injury. The predictive value of the measures indicates that they may represent a useful tool which could aid clinicians in identifying early-on those whose symptoms are likely to persist and who may require ongoing intervention. This could facilitate the planning of rehabilitation programmes.

[A case of favourable outcome of the treatment of extremely severe acute poisoning with methanol].

PubMed

Batotsyrenov, B V; Livanov, G A; Vasil'ev, S A; Fedorov, A V; Antrianov, A Iu

2013-01-01

A case of favourable outcome of the treatment of extremely severe acute poisoning after prolonged exposure to lethal doses of methanol is reported. The complex treatment included urgent and effective elimination of the poison (multiple gastric lavage, hemodialysis), antidote therapy (administration of ethanol), correction of decompensated metabolic acidosis (alkali therapy and infusion therapy with reamberin). These measures had beneficial effect on the clinical course of poisoning and ensured its favourable outcome.

The Popularity of Outcome Measures for Hip and Knee Arthroplasties.

PubMed

Lovelock, Thomas M; Broughton, Nigel S; Williams, Cylie M

2018-01-01

The optimal methods of determining outcomes following hip and knee arthroplasty remain controversial. The objectives of this study were to determine the most frequently used outcome measures in randomized controlled trials (RCT) and study protocols registered with clinical trials registries (CTR) on hip and knee arthroplasty. A systematic search strategy was undertaken to identify the outcome measures used in RCT and CTR following joint arthroplasty. Databases searched included Embase, Ovid MEDLINE (including In-Process), Cochrane Central Register of Controlled Trials, CINAHL Plus, clinicaltrials.gov, ISRCTN registry, and ANZCTR. Differences in the use of outcome measures between RCT and CTR were assessed using logistic regression. There were 291 RCT and 113 CTR on hip arthroplasty and 452 RCT and 184 CTR on knee arthroplasty that met the inclusion criteria. The most popular outcome measures were the Harris Hip Score and the Knee Society Score. Multiple outcome measures were used in greater than 50% of the included studies. The Oxford Hip Score, Oxford Knee Score, EuroQol-5D, and Knee Injury and Osteoarthritis Outcome Score (all P < .001) were used in significantly more CTR than RCT. There is a clear preference for the use of the Harris Hip Score and Knee Society Score, contrary to existing international guidelines and reviews on the topic. Both measures require clinician input, which potentially influences their validity and increases their overall administration cost. Some patient-reported outcome measures, such as the Oxford Hip and Knee Scores, EuroQol-5D, and KOOS, appear to be increasing in popularity. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparing depression screening tools in persons with multiple sclerosis (MS).

PubMed

Hanna, Joshua; Santo, Jonathan B; Blair, Mervin; Smolewska, Kathy; Warriner, Erin; Morrow, Sarah A

2017-02-01

Depression is more common among persons with multiple sclerosis (MS) than the general population. Depression in MS is associated with reduced quality of life, transition to unemployment, and cognitive impairment. Two proposed screening measures for depression in MS populations are the Hospital Anxiety and Depression Scale (HADS) and the Beck Depression Inventory-Fast Screen (BDI-FS). Our objective was to compared the associations of the BDI-FS and the HADS-D scores with history of depressive symptoms, fatigue, and functional outcomes to determine the differential clinical utility of these screening measures among persons with MS. We reviewed charts of 133 persons with MS for demographic information; scores on the HADS, BDI-FS, a fatigue measure, and a processing speed measure; and employment status. Structural equation modeling results indicated the HADS-D predicted employment status, disability status, and processing speed more effectively than did the BDI-FS, whereas both measures predicted fatigue. This study suggests the HADS-D is more effective than the BDI-FS in predicting functional outcomes known to be associated with depression among persons with MS. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The influence of television and video game use on attention and school problems: a multivariate analysis with other risk factors controlled.

PubMed

Ferguson, Christopher J

2011-06-01

Research on youth mental health has increasingly indicated the importance of multivariate analyses of multiple risk factors for negative outcomes. Television and video game use have often been posited as potential contributors to attention problems, but previous studies have not always been well-controlled or used well-validated outcome measures. The current study examines the multivariate nature of risk factors for attention problems symptomatic of attention deficit hyperactivity disorder and poor school performance. A predominantly Hispanic population of 603 children (ages 10-14) and their parents/guardians responded to multiple behavioral measures. Outcome measures included parent and child reported attention problem behaviors on the Child Behavior Checklist (CBCL) as well as poor school performance as measured by grade point average (GPA). Results found that internal factors such as male gender, antisocial traits, family environment and anxiety best predicted attention problems. School performance was best predicted by family income. Television and video game use, whether total time spent using, or exposure to violent content specifically, did not predict attention problems or GPA. Television and video game use do not appear to be significant predictors of childhood attention problems. Intervention and prevention efforts may be better spent on other risk factors. Copyright © 2010 Elsevier Ltd. All rights reserved.

Changes in magnetic resonance imaging disease measures over 3 years in mildly disabled patients with relapsing-remitting multiple sclerosis receiving interferon β-1a in the COGnitive Impairment in MUltiple Sclerosis (COGIMUS) study

PubMed Central

2011-01-01

Background Conventional magnetic resonance imaging (MRI) has improved the diagnosis and monitoring of multiple sclerosis (MS). In clinical trials, MRI has been found to detect treatment effects with greater sensitivity than clinical measures; however, clinical and MRI outcomes tend to correlate poorly. Methods In this observational study, patients (n = 550; 18-50 years; relapsing-remitting MS [Expanded Disability Status Scale score ≤4.0]) receiving interferon (IFN) β-1a therapy (44 or 22 µg subcutaneously [sc] three times weekly [tiw]) underwent standardized MRI, neuropsychological and quality-of-life (QoL) assessments over 3 years. In this post hoc analysis, MRI outcomes and correlations between MRI parameters and clinical and functional outcomes were analysed. Results MRI data over 3 years were available for 164 patients. T2 lesion and T1 gadolinium-enhancing (Gd+) lesion volumes, but not black hole (BH) volumes, decreased significantly from baseline to Year 3 (P < 0.0001). Percentage decreases (baseline to Year 3) were greater with the 44 μg dose than with the 22 μg dose for T2 lesion volume (-10.2% vs -4.5%, P = 0.025) and T1 BH volumes (-7.8% vs +10.3%, P = 0.002). A decrease in T2 lesion volume over 3 years predicted stable QoL over the same time period. Treatment with IFN β-1a, 44 μg sc tiw, predicted an absence of cognitive impairment at Year 3. Conclusion Subcutaneous IFN β-1a significantly decreased MRI measures of disease, with a significant benefit shown for the 44 µg over the 22 µg dose; higher-dose treatment also predicted better cognitive outcomes over 3 years. PMID:21999142

The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results

PubMed Central

Li, Lingsheng; Blake, Caitlin; Sung, Yoon; Shpritz, Barnett; Chen, David; Genther, Dane J.; Betz, Joshua; Lin, Frank R.

2017-01-01

Hearing loss may affect critical domains of health and functioning in older adults. This article describes the rationale and design of the Studying Multiple Outcomes After Aural Rehabilitative Treatment (SMART) study, which was developed to determine to what extent current hearing rehabilitative therapies could mitigate the effects of hearing loss on health outcomes. One hundred and forty-five patients ≥50 years receiving hearing aids (HA) or cochlear implants (CI) were recruited from the Johns Hopkins Department of Otolaryngology-HNS. A standardized outcome battery was administered to assess cognitive, social, mental, and physical functioning. Of the 145 participants aged 50 to 94.9 years who completed baseline evaluations, CI participants had significantly greater loneliness, social isolation, and poorer hearing and communicative function compared with HA participants. This study showed that standardized measures of health-related outcomes commonly used in gerontology appear sensitive to hearing impairment and are feasible to implement in clinical studies of hearing loss. PMID:28491918

Satisfaction with communicative participation as defined by adults with multiple sclerosis: a qualitative study.

PubMed

Yorkston, Kathryn M; Baylor, Carolyn R; Klasner, Estelle R; Deitz, Jean; Dudgeon, Brian J; Eadie, Tanya; Miller, Robert M; Amtmann, Dagmar

2007-01-01

This study examined satisfaction with communicative participation as reported by adults with multiple sclerosis (MS). Eight community-dwelling adults with MS participated in semi-structured interviews. They were asked to discuss their satisfaction with their communication in a variety of situations. Interviews were analyzed using a constant comparative method of qualitative description. Themes derived included: Comfort, consisting of Ease and Confidence; Success of the Outcome, including Function is Achieved and A Connection is Made; and Personal Meaning of Participation, including Personal Preferences, Comparison with the Past, and Thinking about One's Own Communication. Participants described multiple facets of satisfaction with communicative participation. Some of the dimensions were similar to those in existing assessment instruments such as levels of ease or difficulty with performance. Participants did not talk about frequency of activities as a key part of their satisfaction. Implications for identifying intervention targets and treatment outcome measurements are provided. The reader should be able to: 1) define communicative participation and identify key elements of this construct; 2) identify the issues that were most relevant to satisfaction with communicative participation with participants with MS; and 3) identify reasons for greater emphasis on the subjective viewpoint of people with communication disorders in measurement of treatment outcomes.

Family Quality of Life: A Key Outcome in Early Childhood Intervention Services--A Scoping Review

ERIC Educational Resources Information Center

Bhopti, Anoo; Brown, Ted; Lentin, Primrose

2016-01-01

A scoping review was conducted to identify factors influencing the quality of life of families of children with disability. The review also explored the scales used to measure family quality of life (FQOL) as an outcome in early childhood intervention services (ECIS). Multiple databases were searched from 2000 to 2013 to include studies pertinent…

Exploring Student Perceptions of Self-Regulation as a Moderator for Successful Literacy Outcomes: A Multiple Case Study of Fourth-Grade Students

ERIC Educational Resources Information Center

Nellis, Theresa M.

2017-01-01

Self-regulation is a significant predictor of student academic performance, over those traditional measures of intelligence and socioeconomic status. The failure to develop these skills may produce students who are at a four-times greater risk of behavioral issues, school dropout, and poor academic performance. This multiple qualitative case study…

Panel discussion review: Session two - Interpretation of Observed Associations between Multiple Ambient Air Pollutants and Health Effects in Epidemiologic Analysis

EPA Science Inventory

Air pollution epidemiologic research has often utilized ambient air concentrations measured from centrally located monitors as a surrogate measure of exposure to these pollutants. Associations between these ambient concentrations and health outcomes such as lung function, hospita...

Examining the Bricks and Mortar of Socioeconomic Status: An Empirical Comparison of Measurement Methods

ERIC Educational Resources Information Center

Markle, Ross Edward

2010-01-01

The impact of socioeconomic status (SES) on educational outcomes has been widely demonstrated in the fields of sociology, psychology, and educational research. Across these fields however, measurement models of SES vary, including single indicators (parental income, education, and occupation), multiple indicators, hierarchical models, and most…

Attenuating the Systemic Inflammatory Response to Adult Cardiopulmonary Bypass: A Critical Review of the Evidence Base

PubMed Central

Landis, R. Clive; Brown, Jeremiah R.; Fitzgerald, David; Likosky, Donald S.; Shore-Lesserson, Linda; Baker, Robert A.; Hammon, John W.

2014-01-01

Abstract: A wide range of pharmacological, surgical, and mechanical pump approaches have been studied to attenuate the systemic inflammatory response to cardiopulmonary bypass, yet no systematically based review exists to cover the scope of anti-inflammatory interventions deployed. We therefore conducted an evidence-based review to capture “self-identified” anti-inflammatory interventions among adult cardiopulmonary bypass procedures. To be included, trials had to measure at least one inflammatory mediator and one clinical outcome, specified in the “Outcomes 2010” consensus statement. Ninety-eight papers satisfied inclusion criteria and formed the basis of the review. The review identified 33 different interventions and approaches to attenuate the systemic inflammatory response. However, only a minority of papers (35 of 98 [35.7%]) demonstrated any clinical improvement to one or more of the predefined outcome measures (most frequently myocardial protection or length of intensive care unit stay). No single intervention was supported by strong level A evidence (multiple randomized controlled trials [RCTs] or meta-analysis) for clinical benefit. Interventions at level A evidence included off-pump surgery, minimized circuits, biocompatible circuit coatings, leukocyte filtration, complement C5 inhibition, preoperative aspirin, and corticosteroid prophylaxis. Interventions at level B evidence (single RCT) for minimizing inflammation included nitric oxide donors, C1 esterase inhibition, neutrophil elastase inhibition, propofol, propionyl-L-carnitine, and intensive insulin therapy. A secondary analysis revealed that suppression of at least one inflammatory marker was necessary but not sufficient to confer clinical benefit. The most effective interventions were those that targeted multiple inflammatory pathways. These observations are consistent with a “multiple hit” hypothesis, whereby clinically effective suppression of the systemic inflammatory response requires hitting multiple inflammatory targets simultaneously. Further research is warranted to evaluate if combinations of interventions that target multiple inflammatory pathways are capable of synergistically reducing inflammation and improving outcomes after cardiopulmonary bypass. PMID:26357785

Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis.

PubMed

Sebastião, Emerson; Sandroff, Brian M; Learmonth, Yvonne C; Motl, Robert W

2016-07-01

To examine the validity of the timed Up and Go (TUG) test as a measure of functional mobility in persons with multiple sclerosis (MS) by using a comprehensive framework based on construct validity (ie, convergent and divergent validity). Cross-sectional study. Hospital setting. Community-residing persons with MS (N=47). Not applicable. Main outcome measures included the TUG test, timed 25-foot walk test, 6-minute walk test, Multiple Sclerosis Walking Scale-12, Late-Life Function and Disability Instrument, posturography evaluation, Activities-specific Balance Confidence scale, Symbol Digits Modalities Test, Expanded Disability Status Scale, and the number of steps taken per day. The TUG test was strongly associated with other valid outcome measures of ambulatory mobility (Spearman rank correlation, rs=.71-.90) and disability status (rs=.80), moderately to strongly associated with balance confidence (rs=.66), and weakly associated with postural control (ie, balance) (rs=.31). The TUG test was moderately associated with cognitive processing speed (rs=.59), but not associated with other nonambulatory measures (ie, Late-Life Function and Disability Instrument-upper extremity function). Our findings support the validity of the TUG test as a measure of functional mobility. This warrants its inclusion in patients' assessment alongside other valid measures of functional mobility in both clinical and research practice in persons with MS. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Characterizing Tumor Heterogeneity With Functional Imaging and Quantifying High-Risk Tumor Volume for Early Prediction of Treatment Outcome: Cervical Cancer as a Model

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

Mayr, Nina A., E-mail: Nina.Mayr@osumc.edu; Huang Zhibin; Wang, Jian Z.

2012-07-01

Purpose: Treatment response in cancer has been monitored by measuring anatomic tumor volume (ATV) at various times without considering the inherent functional tumor heterogeneity known to critically influence ultimate treatment outcome: primary tumor control and survival. This study applied dynamic contrast-enhanced (DCE) functional MRI to characterize tumors' heterogeneous subregions with low DCE values, at risk for treatment failure, and to quantify the functional risk volume (FRV) for personalized early prediction of treatment outcome. Methods and Materials: DCE-MRI was performed in 102 stage IB{sub 2}-IVA cervical cancer patients to assess tumor perfusion heterogeneity before and during radiation/chemotherapy. FRV represents the totalmore » volume of tumor voxels with critically low DCE signal intensity (<2.1 compared with precontrast image, determined by previous receiver operator characteristic analysis). FRVs were correlated with treatment outcome (follow-up: 0.2-9.4, mean 6.8 years) and compared with ATVs (Mann-Whitney, Kaplan-Meier, and multivariate analyses). Results: Before and during therapy at 2-2.5 and 4-5 weeks of RT, FRVs >20, >13, and >5 cm{sup 3}, respectively, significantly predicted unfavorable 6-year primary tumor control (p = 0.003, 7.3 Multiplication-Sign 10{sup -8}, 2.0 Multiplication-Sign 10{sup -8}) and disease-specific survival (p = 1.9 Multiplication-Sign 10{sup -4}, 2.1 Multiplication-Sign 10{sup -6}, 2.5 Multiplication-Sign 10{sup -7}, respectively). The FRVs were superior to the ATVs as early predictors of outcome, and the differentiating power of FRVs increased during treatment. Discussion: Our preliminary results suggest that functional tumor heterogeneity can be characterized by DCE-MRI to quantify FRV for predicting ultimate long-term treatment outcome. FRV is a novel functional imaging heterogeneity parameter, superior to ATV, and can be clinically translated for personalized early outcome prediction before or as early as 2-5 weeks into treatment.« less

Mediation analysis with multiple versions of the mediator.

PubMed

Vanderweele, Tyler J

2012-05-01

The causal inference literature has provided definitions of direct and indirect effects based on counterfactuals that generalize the approach found in the social science literature. However, these definitions presuppose well-defined hypothetical interventions on the mediator. In many settings, there may be multiple ways to fix the mediator to a particular value, and these various hypothetical interventions may have very different implications for the outcome of interest. In this paper, we consider mediation analysis when multiple versions of the mediator are present. Specifically, we consider the problem of attempting to decompose a total effect of an exposure on an outcome into the portion through the intermediate and the portion through other pathways. We consider the setting in which there are multiple versions of the mediator but the investigator has access only to data on the particular measurement, not information on which version of the mediator may have brought that value about. We show that the quantity that is estimated as a natural indirect effect using only the available data does indeed have an interpretation as a particular type of mediated effect; however, the quantity estimated as a natural direct effect, in fact, captures both a true direct effect and an effect of the exposure on the outcome mediated through the effect of the version of the mediator that is not captured by the mediator measurement. The results are illustrated using 2 examples from the literature, one in which the versions of the mediator are unknown and another in which the mediator itself has been dichotomized.

Mediation analysis with multiple versions of the mediator

PubMed Central

VanderWeele, Tyler J.

2013-01-01

The causal inference literature has provided definitions of direct and indirect effects based on counterfactuals that generalize the approach found in the social science literature. However, these definitions presuppose well defined hypothetical interventions on the mediator. In many settings there may be multiple ways to fix the mediator to a particular value and these different hypothetical interventions may have very different implications for the outcome of interest. In this paper we consider mediation analysis when multiple versions of the mediator are present. Specifically, we consider the problem of attempting to decompose a total effect of an exposure on an outcome into the portion through the intermediate and the portion through other pathways. We consider the setting in which there are multiple versions of the mediator but the investigator only has access to data on the particular measurement, not which version of the mediator may have brought that value about. We show that the quantity that is estimated as a natural indirect effect using only the available data does indeed have an interpretation as a particular type of mediated effect; however, the quantity estimated as a natural direct effect in fact captures both a true direct effect and an effect of the exposure on the outcome mediated through the effect of the version of the mediator that is not captured by the mediator measurement. The results are illustrated using two examples from the literature, one in which the versions of the mediator are unknown and another in which the mediator itself has been dichotomized. PMID:22475830

Comparison of microdose flare-up and antagonist multiple-dose protocols for poor-responder patients: a randomized study.

PubMed

Demirol, Aygul; Gurgan, Timur

2009-08-01

To compare the efficacy of the microdose flare-up and multiple-dose antagonist protocols for poor-responder patients in intracytoplasmic sperm injection-ET cycles. A randomized, prospective study. Center for assisted reproductive technology in Turkey. Ninety patients with poor ovarian response in a minimum of two previous IVF cycles. All women were prospectively randomized into two groups by computer-assisted randomization. The patients in group 1 were stimulated according to the microdose flare-up protocol (n = 45), while the patients in group 2 were stimulated according to antagonist multiple-dose protocol (n = 45). The mean number of mature oocytes retrieved was the primary outcome measure, and fertilization rate, implantation rate per embryo, and clinical pregnancy rates were secondary outcome measures. The mean age of the women, the mean duration of infertility, basal FSH level, and the number of previous IVF cycles were similar in both groups. The total gonadotropin dose used was significantly higher in group 2, while the number of oocytes retrieved was significantly greater in group 1. Although the fertilization and clinical pregnancy rates were nonsignificantly higher in group 1 compared with group 2, the implantation rate was significantly higher in the microdose flare-up group than in the multiple-dose antagonist group (22% vs. 11%). The microdose flare-up protocol seems to have a better outcome in poor-responder patients, with a significantly higher mean number of mature oocytes retrieved and higher implantation rate.

Association between changes on the Negative Symptom Assessment scale (NSA-16) and measures of functional outcome in schizophrenia.

PubMed

Velligan, Dawn I; Alphs, Larry; Lancaster, Scott; Morlock, Robert; Mintz, Jim

2009-09-30

We examined whether changes in negative symptoms, as measured by scores on the 16-item Negative Symptom Assessment scale (NSA-16), were associated with changes in functional outcome. A group of 125 stable outpatients with schizophrenia were assessed at baseline and at 6 months using the NSA-16, the Brief Psychiatric Rating Scale, and multiple measures of functional outcome. Baseline adjusted regression coefficients indicated moderate correlations between negative symptoms and functional outcomes when baseline values of both variables were controlled. Results were nearly identical when we controlled for positive symptoms. Cross-lag panel correlations and Structural Equation Modeling were used to examine whether changes in negative symptoms drove changes in functional outcomes over time. Results indicated that negative symptoms drove the changes in the Social and Occupational Functioning Scale (SOFAS) rather than the reverse. Measures of Quality of Life and measures of negative symptoms may be assessing overlapping constructs or changes in both may be driven by a third variable. Negative symptoms were unrelated over time to scores on a performance-based measure of functional capacity. This study indicates that the relationship between negative symptom change and the change in functional outcomes is complex, and points to potential issues in selection of assessments.

Participation in Pre-High School Football and Neurological, Neuroradiological, and Neuropsychological Findings in Later Life: A Study of 45 Retired National Football League Players.

PubMed

Solomon, Gary S; Kuhn, Andrew W; Zuckerman, Scott L; Casson, Ira R; Viano, David C; Lovell, Mark R; Sills, Allen K

2016-05-01

A recent study found that an earlier age of first exposure (AFE) to tackle football was associated with long-term neurocognitive impairment in retired National Football League (NFL) players. To assess the association between years of exposure to pre-high school football (PreYOE) and neuroradiological, neurological, and neuropsychological outcome measures in a different sample of retired NFL players. Cross-sectional study; Level of evidence, 3. Forty-five former NFL players were included in this study. All participants prospectively completed extensive history taking, a neurological examination, brain magnetic resonance imaging, and a comprehensive battery of neuropsychological tests. To measure the associations between PreYOE and these outcome measures, multiple regression models were utilized while controlling for several covariates. After applying a Bonferroni correction for multiple comparisons, none of the neurological, neuroradiological, or neuropsychological outcome measures yielded a significant relationship with PreYOE. A second Bonferroni-corrected analysis of a subset of these athletes with self-reported learning disability yielded no significant relationships on paper-and-pencil neurocognitive tests but did result in a significant association between learning disability and computerized indices of visual motor speed and reaction time. The current study failed to replicate the results of a prior study, which concluded that an earlier AFE to tackle football might result in long-term neurocognitive deficits. In 45 retired NFL athletes, there were no associations between PreYOE and neuroradiological, neurological, and neuropsychological outcome measures. © 2016 The Author(s).

One session treatment for pediatric blood-injection-injury phobia: A controlled multiple baseline trial.

PubMed

Oar, Ella L; Farrell, Lara J; Waters, Allison M; Conlon, Elizabeth G; Ollendick, Thomas H

2015-10-01

The present study evaluated the effectiveness of a modified One Session Treatment (OST), which included an e-therapy homework maintenance program over 4 weeks for Blood-Injection-Injury (BII) phobia in children and adolescents. Using a single case, non-concurrent multiple-baseline design, 24 children and adolescents (8-18 years; 7 males, 17 females) with a primary diagnosis of BII phobia were randomly assigned to a one, two or three week baseline prior to receiving OST. Primary outcome measures included diagnostic severity, diagnostic status, and child and parent fear ratings. Secondary outcome measures included avoidance during behavioural avoidance tasks (BAT), global functioning and self and parent reported anxiety, fear and depression. Efficacy was assessed at post-treatment, 1-month, and 3-month follow-up. BII symptoms and diagnostic severity remained relatively stable during the baseline periods and then significantly improved following implementation of the intervention. Treatment response was supported by changes across multiple measures, including child, parent and independent clinician ratings. At post-treatment 8 of the 24 (33.33%) children were BII diagnosis free. Treatment gains improved at follow-ups with 14 (58.33%) children diagnosis free at 1-month follow-up and 15 (62.5%) diagnosis free at 3-month follow-up. Preliminary findings support the effectiveness of a modified OST approach for BII phobic youth with treatment outcomes improving over follow-up intervals. Copyright © 2015 Elsevier Ltd. All rights reserved.

Assessing Women's Preferences and Preference Modeling for Breast Reconstruction Decision-Making.

PubMed

Sun, Clement S; Cantor, Scott B; Reece, Gregory P; Crosby, Melissa A; Fingeret, Michelle C; Markey, Mia K

2014-03-01

Women considering breast reconstruction must make challenging trade-offs amongst issues that often conflict. It may be useful to quantify possible outcomes using a single summary measure to aid a breast cancer patient in choosing a form of breast reconstruction. In this study, we used multiattribute utility theory to combine multiple objectives to yield a summary value using nine different preference models. We elicited the preferences of 36 women, aged 32 or older with no history of breast cancer, for the patient-reported outcome measures of breast satisfaction, psychosocial well-being, chest well-being, abdominal well-being, and sexual wellbeing as measured by the BREAST-Q in addition to time lost to reconstruction and out-of-pocket cost. Participants ranked hypothetical breast reconstruction outcomes. We examined each multiattribute utility preference model and assessed how often each model agreed with participants' rankings. The median amount of time required to assess preferences was 34 minutes. Agreement among the nine preference models with the participants ranged from 75.9% to 78.9%. None of the preference models performed significantly worse than the best performing risk averse multiplicative model. We hypothesize an average theoretical agreement of 94.6% for this model if participant error is included. There was a statistically significant positive correlation with more unequal distribution of weight given to the seven attributes. We recommend the risk averse multiplicative model for modeling the preferences of patients considering different forms of breast reconstruction because it agreed most often with the participants in this study.

Multilevel joint competing risk models

NASA Astrophysics Data System (ADS)

Karunarathna, G. H. S.; Sooriyarachchi, M. R.

2017-09-01

Joint modeling approaches are often encountered for different outcomes of competing risk time to event and count in many biomedical and epidemiology studies in the presence of cluster effect. Hospital length of stay (LOS) has been the widely used outcome measure in hospital utilization due to the benchmark measurement for measuring multiple terminations such as discharge, transferred, dead and patients who have not completed the event of interest at the follow up period (censored) during hospitalizations. Competing risk models provide a method of addressing such multiple destinations since classical time to event models yield biased results when there are multiple events. In this study, the concept of joint modeling has been applied to the dengue epidemiology in Sri Lanka, 2006-2008 to assess the relationship between different outcomes of LOS and platelet count of dengue patients with the district cluster effect. Two key approaches have been applied to build up the joint scenario. In the first approach, modeling each competing risk separately using the binary logistic model, treating all other events as censored under the multilevel discrete time to event model, while the platelet counts are assumed to follow a lognormal regression model. The second approach is based on the endogeneity effect in the multilevel competing risks and count model. Model parameters were estimated using maximum likelihood based on the Laplace approximation. Moreover, the study reveals that joint modeling approach yield more precise results compared to fitting two separate univariate models, in terms of AIC (Akaike Information Criterion).

Defining a set of standardised outcome measures for newly diagnosed patients with multiple myeloma using the Delphi consensus method: the IMPORTA project.

PubMed

Blade, Joan; Calleja, Miguel Ángel; Lahuerta, Juan José; Poveda, José Luis; de Paz, Héctor David; Lizán, Luis

2018-02-22

To define a standard set of outcomes and the most appropriate instruments to measure them for managing newly diagnosed patients with multiple myeloma (MM). A literature review and five discussion groups facilitated the design of two-round Delphi questionnaire. Delphi panellists (haematologists, hospital pharmacists and patients) were identified by the scientific committee, the Spanish Program of Haematology Treatments Foundation, the Spanish Society of Hospital Pharmacies and the Spanish Community of Patients with MM. Panellist's perception about outcomes' suitability and feasibility of use was assessed on a seven-point Likert scale. Consensus was reached when at least 75% of the respondents reached agreement or disagreement. A scientific committee led the project. Fifty-one and 45 panellists participated in the first and second Delphi rounds, respectively. Consensus was reached to use overall survival, progression-free survival, minimal residual disease and treatment response to assess survival and disease control. Panellists agreed to measure health-related quality of life, pain, performance status, fatigue, psychosocial status, symptoms, self-perception on body image, sexuality and preferences/satisfaction. However, panellist did not reach consensus about the feasibility of assessing in routine practice psychosocial status, symptoms, self-perception on body image and sexuality. Consensus was reached to collect patient-reported outcomes through the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core questionnaire 30 (C30), three items from EORTC-QLQ-Multiple Myeloma (MY20) and EORTC-QLQ-Breast Cancer (BR23), pain Visual Analogue Scale, Morisky-Green and ad hoc questions about patients' preferences/satisfaction. A consensual standard set of outcomes for managing newly diagnosed patients with MM has been defined. The feasibility of its implementation in routine practice will be assessed in a future pilot study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Do Wellness Tourists Get Well? An Observational Study of Multiple Dimensions of Health and Well-Being After a Week-Long Retreat.

PubMed

Cohen, Marc M; Elliott, Fiona; Oates, Liza; Schembri, Adrian; Mantri, Nitin

2017-02-01

Wellness retreats use many complementary and alternative therapies within a holistic residential setting, yet few studies have evaluated the effect of retreat experiences on multiple dimensions of health and well-being, and no published studies have reported health outcomes in wellness tourists. To assess the effect of a week-long wellness-retreat experience in wellness tourists. A longitudinal observational study with outcomes assessed upon arrival and departure and 6 weeks after the retreat. A rural health retreat in Queensland, Australia. A holistic, 1-week, residential, retreat experience that included many educational, therapeutic, and leisure activities and an organic, mostly plant-based diet. Multiple outcome measures were performed upon arrival and departure and 6 weeks after the retreat. These included anthropometric measures, urinary pesticide metabolites, a food and health symptom questionnaire, the Five Factor Wellness Inventory, the General Self Efficacy questionnaire, the Pittsburgh Insomnia Rating Scale, the Depression Anxiety Stress Scale, the Profile of Mood States, and the Cogstate cognitive function test battery. Statistically significant improvements (p < 0.05) were seen in almost all measures (n = 37) after 1 week and were sustained at 6 weeks (n = 17). There were statistically significant improvements (p < 0.001) in all anthropometric measures after 1 week, with reductions in abdominal girth (2.7 cm), weight (1.6 kg), and average systolic and diastolic pressure (-16.1 mmHg and -9.3 mmHg, respectively). Statistically significant improvements (p < 0.05) were also seen in psychological and health symptom measures. Urinary pesticide metabolites were detected in pooled urine samples before the retreat and were undetectable after the retreat. Retreat experiences can lead to substantial improvements in multiple dimensions of health and well-being that are maintained for 6 weeks. Further research that includes objective biomarkers and economic measures in different populations is required to determine the mechanisms of these effects and assess the value and relevance of retreat experiences to clinicians and health insurers.

Multiple indicators, multiple causes measurement error models

DOE PAGES

Tekwe, Carmen D.; Carter, Randy L.; Cullings, Harry M.; ...

2014-06-25

Multiple indicators, multiple causes (MIMIC) models are often employed by researchers studying the effects of an unobservable latent variable on a set of outcomes, when causes of the latent variable are observed. There are times, however, when the causes of the latent variable are not observed because measurements of the causal variable are contaminated by measurement error. The objectives of this study are as follows: (i) to develop a novel model by extending the classical linear MIMIC model to allow both Berkson and classical measurement errors, defining the MIMIC measurement error (MIMIC ME) model; (ii) to develop likelihood-based estimation methodsmore » for the MIMIC ME model; and (iii) to apply the newly defined MIMIC ME model to atomic bomb survivor data to study the impact of dyslipidemia and radiation dose on the physical manifestations of dyslipidemia. Finally, as a by-product of our work, we also obtain a data-driven estimate of the variance of the classical measurement error associated with an estimate of the amount of radiation dose received by atomic bomb survivors at the time of their exposure.« less

Multiple Indicators, Multiple Causes Measurement Error Models

PubMed Central

Tekwe, Carmen D.; Carter, Randy L.; Cullings, Harry M.; Carroll, Raymond J.

2014-01-01

Multiple Indicators, Multiple Causes Models (MIMIC) are often employed by researchers studying the effects of an unobservable latent variable on a set of outcomes, when causes of the latent variable are observed. There are times however when the causes of the latent variable are not observed because measurements of the causal variable are contaminated by measurement error. The objectives of this paper are: (1) to develop a novel model by extending the classical linear MIMIC model to allow both Berkson and classical measurement errors, defining the MIMIC measurement error (MIMIC ME) model, (2) to develop likelihood based estimation methods for the MIMIC ME model, (3) to apply the newly defined MIMIC ME model to atomic bomb survivor data to study the impact of dyslipidemia and radiation dose on the physical manifestations of dyslipidemia. As a by-product of our work, we also obtain a data-driven estimate of the variance of the classical measurement error associated with an estimate of the amount of radiation dose received by atomic bomb survivors at the time of their exposure. PMID:24962535

Multiple indicators, multiple causes measurement error models

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

Tekwe, Carmen D.; Carter, Randy L.; Cullings, Harry M.

Multiple indicators, multiple causes (MIMIC) models are often employed by researchers studying the effects of an unobservable latent variable on a set of outcomes, when causes of the latent variable are observed. There are times, however, when the causes of the latent variable are not observed because measurements of the causal variable are contaminated by measurement error. The objectives of this study are as follows: (i) to develop a novel model by extending the classical linear MIMIC model to allow both Berkson and classical measurement errors, defining the MIMIC measurement error (MIMIC ME) model; (ii) to develop likelihood-based estimation methodsmore » for the MIMIC ME model; and (iii) to apply the newly defined MIMIC ME model to atomic bomb survivor data to study the impact of dyslipidemia and radiation dose on the physical manifestations of dyslipidemia. Finally, as a by-product of our work, we also obtain a data-driven estimate of the variance of the classical measurement error associated with an estimate of the amount of radiation dose received by atomic bomb survivors at the time of their exposure.« less

Race and Gender Differences in One-Year Outcomes for Community-Dwelling Stroke Survivors with Family Caregivers

PubMed Central

Roth, David L.; Haley, William E.; Clay, Olivio J.; Perkins, Martinique; Grant, Joan S.; Rhodes, J. David; Wadley, Virginia G.; Kissela, Brett; Howard, George

2011-01-01

Background and Purpose Previous research has reported worse outcomes after stroke for women and for African Americans, but few prospective, population-based studies have systematically examined demographic differences on long-term stroke outcomes. Race and gender differences on one-year stroke outcomes were examined using an epidemiologically-derived sample of first-time stroke survivors from the national REasons for Geographic and Racial Differences in Stroke (REGARDS) study. Methods Participants of REGARDS who reported a first-time stroke event during regular surveillance calls were interviewed by telephone and then completed an in-home evaluation approximately one year after the verified first-time stroke event (N = 112). A primary family caregiver was also enrolled and interviewed for each stroke survivor. Measures from the in-home evaluation included previously validated stroke outcomes assessments of neurological deficits, functional impairments, and patient-reported effects of stroke in multiple domains. Results African American stroke survivors were less likely to be living with their primary family caregivers than White participants. Analyses that controlled for age, education, and whether the stroke survivors lived with their primary family caregivers indicated that African Americans and women showed significantly greater deficits on multiple one-year outcome measures compared to Whites and men, respectively. Conclusions Among community-dwelling stroke survivors with family caregivers, women and African Americans are at heightened risk for poor long-term outcomes one year after first-time stroke events. Rehabilitation services and public health policies aimed at enhancing stroke recovery rates should address these disparities in post-stroke outcomes. PMID:21257820

Effect of Contralateral Strength Training on Muscle Weakness in People With Multiple Sclerosis: Proof-of-Concept Case Series.

PubMed

Manca, Andrea; Cabboi, Maria Paola; Ortu, Enzo; Ginatempo, Francesca; Dragone, Daniele; Zarbo, Ignazio Roberto; de Natale, Edoardo Rosario; Mureddu, Giovanni; Bua, Guido; Deriu, Franca

2016-06-01

The contralateral strength training (CST) effect is a transfer of muscle performance to the untrained limb following training of the contralateral side. The aim of this study was to explore, in individuals with multiple sclerosis (MS) presenting marked lower limb strength asymmetry, the effectiveness of CST on management of muscle weakness of the more-affected limb following training of the less-affected limb. A single-subject research design was used. Eight individuals with MS underwent 16 to 18 high-intensity training sessions of the less-affected ankle dorsiflexor muscles. The primary outcome measure of this single-system case series was maximal strength expressed as peak moment and maximal work. Secondary outcome measures were: Six-Minute-Walk Test, Timed "Up & Go" Test, 10-Meter Timed Walk Test, and Multiple Sclerosis Quality of Life-54 questionnaire. After the 6-week intervention, the contralateral more affected (untrained) limb showed a 22% to 24% increase in maximal strength. From pretest-posttest measurements, participants also performed significantly better on the clinical and functional secondary outcome measures. At the 12-week follow-up, the strength levels of the weaker untrained limb remained significantly superior to baseline levels in the majority (5 out of 8) of the outcome parameters. Considering the design used, the absence of a control group, and the sample size, these findings should be cautiously generalized and will need confirmation in a properly planned randomized controlled trial. The present proof-of-concept study shows, for the first time, the occurrence of the CST effect on muscle performance of ankle dorsiflexor muscles in people with MS. These preliminary findings reveal new potential implications for CST as a promising rehabilitation approach to those conditions where unilateral muscle weakness does not allow or makes difficult performing conventional strength training of the weaker limb. © 2016 American Physical Therapy Association.

Neuromuscular electrical stimulation and the treatment of lower urinary tract dysfunction in multiple sclerosis--a double blind, placebo controlled, randomised clinical trial.

PubMed

McClurg, D; Ashe, R G; Lowe-Strong, A S

2008-01-01

Lower urinary tract dysfunction affects up to 75% of the multiple sclerosis population. Results from our recent Pilot Study (McClurg et al., 2006) indicated that a combined programme of pelvic floor muscle training, electromyography biofeedback and neuromuscular electrical stimulation modalities may alleviate some of the distressing symptoms within this population. This clinical trial aimed to evaluate further the efficacy of these interventions and to establish the benefit of neuromuscular electrical stimulation above and beyond that of EMG biofeedback and pelvic floor muscle training. 74 multiple sclerosis patients who presented with lower urinary tract dysfunction were randomly allocated to one of two groups - Group 1 received Pelvic Floor Muscle Training, Electromyography Biofeedback and Placebo Neuromuscular Electrical Stimulation (n=37), and Group 2 which received Pelvic Floor Muscle Training, Electromyography Biofeedback, and Active Neuromuscular Electrical Stimulation (n=37). Treatment was for nine weeks with outcome measures recorded at weeks 0, 9, 16 and 24. The Primary Outcome Measure was the number of leakage episodes. Within group analysis was by Paired Samples t-test. Group differences were analysed using Repeated Measures Analysis of Variance and Post-hoc tests were used to determine the significance of differences between Groups at each time point. The mean number of incontinence episodes were reduced in Group 2 by 85% (p=0.001) whereas in Group 1 a lesser reduction of 47% (p=0.001) was observed. However, there was a statistically superior benefit in Group 2 when compared to Group 1 (p=0.0028). This superior benefit was evident in all other outcome measures. The addition of Active Neuromuscular Electrical Stimulation to a programme of Pelvic Floor Muscle Training and Electromyography Biofeedback should be considered as a first-line option in alleviating some of the symptoms of lower urinary tract dysfunction associated with multiple sclerosis. (c) 2007 Wiley-Liss, Inc.

Retention in Differentiated Care: Multiple Measures Analysis for a Decentralized HIV Care and Treatment Program in North Central Nigeria

PubMed Central

Agaba, Patricia A; Genberg, Becky L; Sagay, Atiene S; Agbaji, Oche O; Meloni, Seema T; Dadem, Nancin Y; Kolawole, Grace O; Okonkwo, Prosper; Kanki, Phyllis J; Ware, Norma C

2018-01-01

Objective Differentiated care refers collectively to flexible service models designed to meet the differing needs of HIV-infected persons in resource-scarce settings. Decentralization is one such service model. Retention is a key indicator for monitoring the success of HIV treatment and care programs. We used multiple measures to compare retention in a cohort of patients receiving HIV care at “hub” (central) and “spoke” (decentralized) sites in a large public HIV treatment program in north central Nigeria. Methods This retrospective cohort study utilized longitudinal program data representing central and decentralized levels of care in the Plateau State Decentralization Initiative, north central Nigeria. We examined retention with patient- level (retention at fixed times, loss-to-follow-up [LTFU]) and visit-level (gaps-in-care, visit constancy) measures. Regression models with generalized estimating equations (GEE) were used to estimate the effect of decentralization on visit-level measures. Patient-level measures were examined using survival methods with Cox regression models, controlling for baseline variables. Results Of 15,650 patients, 43% were enrolled at the hub. Median time in care was 3.1 years. Hub patients were less likely to be LTFU (adjusted hazard ratio (AHR)=0.91, 95% CI: 0.85-0.97), compared to spoke patients. Visit constancy was lower at the hub (−4.5%, 95% CI: −3.5, −5.5), where gaps in care were also more likely to occur (adjusted odds ratio=1.95, 95% CI: 1.83-2.08). Conclusion Decentralized sites demonstrated better retention outcomes using visit-level measures, while the hub achieved better retention outcomes using patient-level measures. Retention estimates produced by incorporating multiple measures showed substantial variation, confirming the influence of measurement strategies on the results of retention research. Future studies of retention in HIV care in sub-Saharan Africa will be well-served by including multiple measures. PMID:29682399

Retention in Differentiated Care: Multiple Measures Analysis for a Decentralized HIV Care and Treatment Program in North Central Nigeria.

PubMed

Agaba, Patricia A; Genberg, Becky L; Sagay, Atiene S; Agbaji, Oche O; Meloni, Seema T; Dadem, Nancin Y; Kolawole, Grace O; Okonkwo, Prosper; Kanki, Phyllis J; Ware, Norma C

2018-01-01

Differentiated care refers collectively to flexible service models designed to meet the differing needs of HIV-infected persons in resource-scarce settings. Decentralization is one such service model. Retention is a key indicator for monitoring the success of HIV treatment and care programs. We used multiple measures to compare retention in a cohort of patients receiving HIV care at "hub" (central) and "spoke" (decentralized) sites in a large public HIV treatment program in north central Nigeria. This retrospective cohort study utilized longitudinal program data representing central and decentralized levels of care in the Plateau State Decentralization Initiative, north central Nigeria. We examined retention with patient- level (retention at fixed times, loss-to-follow-up [LTFU]) and visit-level (gaps-in-care, visit constancy) measures. Regression models with generalized estimating equations (GEE) were used to estimate the effect of decentralization on visit-level measures. Patient-level measures were examined using survival methods with Cox regression models, controlling for baseline variables. Of 15,650 patients, 43% were enrolled at the hub. Median time in care was 3.1 years. Hub patients were less likely to be LTFU (adjusted hazard ratio (AHR)=0.91, 95% CI: 0.85-0.97), compared to spoke patients. Visit constancy was lower at the hub (-4.5%, 95% CI: -3.5, -5.5), where gaps in care were also more likely to occur (adjusted odds ratio=1.95, 95% CI: 1.83-2.08). Decentralized sites demonstrated better retention outcomes using visit-level measures, while the hub achieved better retention outcomes using patient-level measures. Retention estimates produced by incorporating multiple measures showed substantial variation, confirming the influence of measurement strategies on the results of retention research. Future studies of retention in HIV care in sub-Saharan Africa will be well-served by including multiple measures.

Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

PubMed

Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

2010-10-01

In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

Applied immuno-epidemiological research: an approach for integrating existing knowledge into the statistical analysis of multiple immune markers.

PubMed

Genser, Bernd; Fischer, Joachim E; Figueiredo, Camila A; Alcântara-Neves, Neuza; Barreto, Mauricio L; Cooper, Philip J; Amorim, Leila D; Saemann, Marcus D; Weichhart, Thomas; Rodrigues, Laura C

2016-05-20

Immunologists often measure several correlated immunological markers, such as concentrations of different cytokines produced by different immune cells and/or measured under different conditions, to draw insights from complex immunological mechanisms. Although there have been recent methodological efforts to improve the statistical analysis of immunological data, a framework is still needed for the simultaneous analysis of multiple, often correlated, immune markers. This framework would allow the immunologists' hypotheses about the underlying biological mechanisms to be integrated. We present an analytical approach for statistical analysis of correlated immune markers, such as those commonly collected in modern immuno-epidemiological studies. We demonstrate i) how to deal with interdependencies among multiple measurements of the same immune marker, ii) how to analyse association patterns among different markers, iii) how to aggregate different measures and/or markers to immunological summary scores, iv) how to model the inter-relationships among these scores, and v) how to use these scores in epidemiological association analyses. We illustrate the application of our approach to multiple cytokine measurements from 818 children enrolled in a large immuno-epidemiological study (SCAALA Salvador), which aimed to quantify the major immunological mechanisms underlying atopic diseases or asthma. We demonstrate how to aggregate systematically the information captured in multiple cytokine measurements to immunological summary scores aimed at reflecting the presumed underlying immunological mechanisms (Th1/Th2 balance and immune regulatory network). We show how these aggregated immune scores can be used as predictors in regression models with outcomes of immunological studies (e.g. specific IgE) and compare the results to those obtained by a traditional multivariate regression approach. The proposed analytical approach may be especially useful to quantify complex immune responses in immuno-epidemiological studies, where investigators examine the relationship among epidemiological patterns, immune response, and disease outcomes.

Toward the Development of Integrative Risk-Adjusted Measures of Quality Using Large Clinical Data Bases: The Case of Anesthesia Services.

ERIC Educational Resources Information Center

Fleming, Steven T.

1992-01-01

The concept of risk-adjusted measures of quality is discussed, and a methodology is proposed for risk-adjusting and integrating multiple adverse outcomes of anesthesia services into measures for quality assurance and quality improvement programs. Although designed for a new anesthesiology database, the methods should apply to other health…

Randomized controlled pilot study of customized pamphlets to promote physical activity and symptom self-management in women with multiple sclerosis.

PubMed

Plow, Matthew; Bethoux, Francois; McDaniel, Corey; McGlynn, Mark; Marcus, Bess

2014-02-01

Investigate the feasibility and potential efficacy of a customized print-based intervention to promote physical activity and symptom self-management in women with multiple sclerosis. A randomly allocated two-group repeated measures design, with a delayed-treatment contact group serving as the control. Participants were randomized to receive the intervention immediately (n =14) or receive it at week 12 (n =16). Outcome measures were administered at weeks 1, 12, and 24. Community-based in metropolitan area. Thirty women with multiple sclerosis. Prescribing a home-exercise program and following up with customized pamphlets, which are matched to participants' stage of readiness to change physical activity behavior and physical activity barriers (e.g. encouraging self-management of symptoms). Physical Activity and Disability Survey-revised, Godin Leisure-Time Exercise Questionnaire, SF-12, Symptoms of Multiple Sclerosis Scale, and 6-minute walk test. Intent-to-treat analyses using mixed multivariate analysis of variance (MANOVA) were conducted on (1) physical activity levels and (2) health and function outcomes. The mixed MANOVAs for physical activity levels and health and function outcomes indicated significant improvements in the immediate group compared with the delayed group (i.e. condition by time interaction was significant, Wilks' λ = 0.59, F(2, 27) = 9.31, P = 0.001 and Wilks' λ = 0.70, F(4, 25) = 2.72, P = 0.052, respectively). The intervention had moderate to large effect sizes in improving physical activity levels (d = 0.63 to 0.89), perceptions of physical function (d = 0.63), and 6-minute walk test (d=0.86). This pilot study indicates that a customized print-based intervention shows promise in improving physical activity levels and health and function in women with multiple sclerosis.

An Examination of Alternate Assessment Durations when Assessing Multiple-Skill Computational Fluency: The Generalizability and Dependability of Curriculum-Based Outcomes within the Context of Educational Decisions

ERIC Educational Resources Information Center

Christ, Theodore J.; Johnson-Gros, Kristin H.

2005-01-01

The current study extended previous research on curriculum-based measurement in mathematics (M-CBM) assessments. The purpose was to examine the generalizability and dependability of multiple-skill M-CBM computation assessments across various assessment durations (1, 2, 3, 4, 5, and 6 minutes). Results of generalizability and dependability studies…

The relationship between supervisor support and registered nurse outcomes in nursing care units.

PubMed

Hall, Debra S

2007-01-01

Workplace social support is a major characteristic related to the Job Demand-Control model of job stress. Organizational and managerial support have an effect on nurse satisfaction and burnout. The relationships between perceived supervisor support and measures of nurse occupation-related outcomes were investigated in 3 nursing units within an academic medical center. Nurses with greater levels of perceived supervisor support experienced more positive job outcomes and less negative outcomes, including less occupational stress, than nurses with less perceived supervisor support. Implications for refocusing the role of the nurse supervisor and its effect on multiple nursing occupation-related outcomes are discussed.

Assessment of Cross-Chemical Predictibility for Changes in Serum Clinical Bioindicators and EEG Produced by Pesticides with Different Modes of Action

EPA Science Inventory

Electroencephalography (EEG) is often used as an apical measure of multiple types of central nervous system (CNS) changes, while biomarkers in blood may serve as predictors for adverse outcomes. Correlation between these two measures would suggest that certain changes in biomarke...

Disability and Fatigue Can Be Objectively Measured in Multiple Sclerosis

PubMed Central

Motta, Caterina; Palermo, Eduardo; Studer, Valeria; Germanotta, Marco; Germani, Giorgio; Centonze, Diego; Cappa, Paolo

2016-01-01

Background The available clinical outcome measures of disability in multiple sclerosis are not adequately responsive or sensitive. Objective To investigate the feasibility of inertial sensor-based gait analysis in multiple sclerosis. Methods A cross-sectional study of 80 multiple sclerosis patients and 50 healthy controls was performed. Lower-limb kinematics was evaluated by using a commercially available magnetic inertial measurement unit system. Mean and standard deviation of range of motion (mROM, sROM) for each joint of lower limbs were calculated in one minute walking test. A motor performance index (E) defined as the sum of sROMs was proposed. Results We established two novel observer-independent measures of disability. Hip mROM was extremely sensitive in measuring lower limb motor impairment, being correlated with muscle strength and also altered in patients without clinically detectable disability. On the other hand, E index discriminated patients according to disability, being altered only in patients with moderate and severe disability, regardless of walking speed. It was strongly correlated with fatigue and patient-perceived health status. Conclusions Inertial sensor-based gait analysis is feasible and can detect clinical and subclinical disability in multiple sclerosis. PMID:26863109

Disparities at the intersection of marginalized groups

PubMed Central

Jackson, John W.; Williams, David R.; VanderWeele, Tyler J.

2016-01-01

Mental health disparities exist across several dimensions of social inequality, including race/ethnicity, socioeconomic status and gender. Most investigations of health disparities focus on one dimension. Recent calls by researchers argue for studying persons who are marginalized in multiple ways, often from the perspective of intersectionality, a theoretical framework applied to qualitative studies in law, sociology, and psychology. Quantitative adaptations are emerging but there is little guidance as to what measures or methods are helpful. Here, we consider the concept of a joint disparity and its composition, show that this approach can illuminate how outcomes are patterned for social groups that are marginalized across multiple axes of social inequality, and compare the insights gained with that of other measures of additive interaction. We apply these methods to a cohort of males from the National Longitudinal Survey of Youth, examining disparities for black males with low early life SES vs. white males with high early life SES across several outcomes that predict mental health, including unemployment, wages, and incarceration. We report striking disparities in each outcome, but show that the contribution of race, SES, and their intersection varies. PMID:27531592

Disparities at the intersection of marginalized groups.

PubMed

Jackson, John W; Williams, David R; VanderWeele, Tyler J

2016-10-01

Mental health disparities exist across several dimensions of social inequality, including race/ethnicity, socioeconomic status and gender. Most investigations of health disparities focus on one dimension. Recent calls by researchers argue for studying persons who are marginalized in multiple ways, often from the perspective of intersectionality, a theoretical framework applied to qualitative studies in law, sociology, and psychology. Quantitative adaptations are emerging but there is little guidance as to what measures or methods are helpful. Here, we consider the concept of a joint disparity and its composition, show that this approach can illuminate how outcomes are patterned for social groups that are marginalized across multiple axes of social inequality, and compare the insights gained with that of other measures of additive interaction. We apply these methods to a cohort of young men from the National Longitudinal Survey of Youth, examining disparities for black men with low early life SES vs. white men with high early life SES across several outcomes that predict mental health, including unemployment, wages, and incarceration. We report striking disparities in each outcome, but show that the contribution of race, SES, and their intersection varies.

Multiple aspects of high school students' strategic processing on reading outcomes: The role of quantity, quality, and conjunctive strategy use.

PubMed

Parkinson, Meghan M; Dinsmore, Daniel L

2018-03-01

While the literature on strategy use is relatively mature, measures of strategy use overwhelmingly measure only one aspect of that use, frequency, when relating that strategy use to performance outcomes. While this might be one important attribute of strategy use, there is increasing evidence that quality and conditional use of cognitive and metacognitive strategies may also be important. This study examines how multiple aspects of strategy use, namely frequency, quality, and conjunctive use of strategies, influence task performance on both well- and ill-structured task outcomes in addition to other concomitant variables that may interact with strategic processing during reading. The sample consisted of 21 high school students enrolled in an upper-level biology class in a suburban school in the north-eastern United States. These participants completed measures of prior knowledge and interest, then read either an expository or persuasive text while thinking aloud. They then completed a passage recall and open-ended response following passage completion. In general, quantity was not positively related to the study outcomes and was negatively related to one of them. Quality of strategy use, on the other hand, was consistently related to positive reading outcomes. The influence of knowledge and interest in terms of strategies is also discussed as well as six cases which illustrate the relation of aspects of strategy use and the other concomitant variables. Evaluating strategy use by solely examining the frequency of strategy use did not explain differences in task performance as well as evaluating the quality and conjunctive use of strategies. Further, important relations between prior knowledge, interest, and the task outcomes appeared to be mediated and moderated by the aspects of strategy use investigated. © 2017 The British Psychological Society.

A longitudinal analysis of nursing home outcomes.

PubMed

Porell, F; Caro, F G; Silva, A; Monane, M

1998-10-01

To investigate resident and facility attributes associated with long-term care health outcomes in nursing homes. Quarterly Management Minutes Questionnaire (MMQ) survey data for Medicaid case-mix reimbursement of nursing homes in Massachusetts from 1991 to 1994, for specification of outcomes and resident attributes. Facility attributes are specified from cost report data. Multivariate logistic and "state-dependence" regression models are estimated for survival, ADL functional status, incontinence status, and mental status outcomes from longitudinal residence histories of Medicaid residents spanning 3 to 36 months in length. Outcomes are specified to be a function of resident demographic and diagnostic attributes and facility-level operating and nurse staffing attributes. The estimated parameters for resident demographic and diagnostic attributes showed a great deal of construct validity with respect to clinical expectations regarding risk factors for adverse outcomes. Few facility attributes were associated with outcomes generally, and none was significantly associated with all four outcomes. The absence of uniform associations between facility attributes and the various long-term care health outcomes studied suggests that strong facility performance on one health outcome may coexist with much weaker performance on other outcomes. This has implications for the aggregation of individual facility performance measures on multiple outcomes and the development of overall outcome performance measures.

Plantarflexor weakness negatively impacts walking in persons with multiple sclerosis more than plantarflexor spasticity

PubMed Central

Wagner, Joanne M.; Kremer, Theodore R.; Van Dillen, Linda R.; Naismith, Robert T.

2014-01-01

Objective To determine if plantarflexor (PF) spasticity or ankle strength best predicts variance in walking capacity or self-perceived limitations in walking in persons with multiple sclerosis (pwMS), and if pwMS with PF spasticity are weaker and have greater walking dysfunction than pwMS without PF spasticity. Design Cross-sectional study. Setting University research laboratory. Participants Forty-two pwMS (age: 42.9 ± 10.1 years; Expanded Disability Status Scale (EDSS): median = 3.0, range = 0–6) and 14 adults without disability (WD) (age: 41.9 ± 10.1 years). Intervention Not applicable. Main Outcome Measures PF spasticity and dorsiflexion (DF) and PF maximum voluntary isometric torque (MVIT) were assessed using the Modified Ashworth Scale (MAS) and a computerized dynamometer, respectively. The Timed 25-Foot Walk Test (T25FWT) was the primary outcome measure of walking capacity. Secondary measures included the Six Minute Walk Test (6MWT) and 12-item Multiple Sclerosis Walking Scale (MSWS-12). Results PF strength was the most consistent predictor of the variance in walking capacity (T25FWT: R2 change = 0.23 to 0.29, p ≤ 0.001; 6MWT: R2 change = 0.12 to 0.29, p ≤ 0.012), and self-perceived limitations of walking (MSWS-12: R2 change = 0.04 to 0.14, p < 0.18). There were no significant differences (p > 0.05) between the pwMS with PF spasticity and pwMS without PF spasticity for any of the outcome measures. Conclusions Our study suggests a unique contribution of PF weakness to walking dysfunction in pwMS, and highlights the importance of evaluating PF strength in this clinical population. PMID:24582617

Latent variable models for gene-environment interactions in longitudinal studies with multiple correlated exposures.

PubMed

Tao, Yebin; Sánchez, Brisa N; Mukherjee, Bhramar

2015-03-30

Many existing cohort studies designed to investigate health effects of environmental exposures also collect data on genetic markers. The Early Life Exposures in Mexico to Environmental Toxicants project, for instance, has been genotyping single nucleotide polymorphisms on candidate genes involved in mental and nutrient metabolism and also in potentially shared metabolic pathways with the environmental exposures. Given the longitudinal nature of these cohort studies, rich exposure and outcome data are available to address novel questions regarding gene-environment interaction (G × E). Latent variable (LV) models have been effectively used for dimension reduction, helping with multiple testing and multicollinearity issues in the presence of correlated multivariate exposures and outcomes. In this paper, we first propose a modeling strategy, based on LV models, to examine the association between repeated outcome measures (e.g., child weight) and a set of correlated exposure biomarkers (e.g., prenatal lead exposure). We then construct novel tests for G × E effects within the LV framework to examine effect modification of outcome-exposure association by genetic factors (e.g., the hemochromatosis gene). We consider two scenarios: one allowing dependence of the LV models on genes and the other assuming independence between the LV models and genes. We combine the two sets of estimates by shrinkage estimation to trade off bias and efficiency in a data-adaptive way. Using simulations, we evaluate the properties of the shrinkage estimates, and in particular, we demonstrate the need for this data-adaptive shrinkage given repeated outcome measures, exposure measures possibly repeated and time-varying gene-environment association. Copyright © 2014 John Wiley & Sons, Ltd.

Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process.

PubMed

Bujkiewicz, Sylwia; Thompson, John R; Riley, Richard D; Abrams, Keith R

2016-03-30

A number of meta-analytical methods have been proposed that aim to evaluate surrogate endpoints. Bivariate meta-analytical methods can be used to predict the treatment effect for the final outcome from the treatment effect estimate measured on the surrogate endpoint while taking into account the uncertainty around the effect estimate for the surrogate endpoint. In this paper, extensions to multivariate models are developed aiming to include multiple surrogate endpoints with the potential benefit of reducing the uncertainty when making predictions. In this Bayesian multivariate meta-analytic framework, the between-study variability is modelled in a formulation of a product of normal univariate distributions. This formulation is particularly convenient for including multiple surrogate endpoints and flexible for modelling the outcomes which can be surrogate endpoints to the final outcome and potentially to one another. Two models are proposed, first, using an unstructured between-study covariance matrix by assuming the treatment effects on all outcomes are correlated and second, using a structured between-study covariance matrix by assuming treatment effects on some of the outcomes are conditionally independent. While the two models are developed for the summary data on a study level, the individual-level association is taken into account by the use of the Prentice's criteria (obtained from individual patient data) to inform the within study correlations in the models. The modelling techniques are investigated using an example in relapsing remitting multiple sclerosis where the disability worsening is the final outcome, while relapse rate and MRI lesions are potential surrogates to the disability progression. © 2015 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Systematic Review of Programs Treating High-Need and High-Cost People With Multiple Chronic Diseases or Disabilities in the United States, 2008–2014

PubMed Central

Bleich, Sara N.; Sherrod, Cheryl; Chiang, Anne; Boyd, Cynthia; Wolff, Jennifer; DuGoff, Eva; Salzberg, Claudia; Anderson, Keely; Leff, Bruce

2015-01-01

Introduction Finding ways to provide better and less expensive health care for people with multiple chronic conditions or disability is a pressing concern. The purpose of this systematic review was to evaluate different approaches for caring for this high-need and high-cost population. Methods We searched Medline for articles published from May 31, 2008, through June 10, 2014, for relevant studies. Articles were considered eligible for this review if they met the following criteria: included people with multiple chronic conditions (behavioral or mental health) or disabilities (2 or more); addressed 1 or more of clinical outcomes, health care use and spending, or patient satisfaction; and compared results from an intervention group with a comparison group or baseline measurements. We extracted information on program characteristics, participant characteristics, and significant (positive and negative) clinical findings, patient satisfaction, and health care use outcomes. For each outcome, the number of significant and positive results was tabulated. Results Twenty-seven studies were included across 5 models of care. Of the 3 studies reporting patient satisfaction outcomes, 2 reported significant improvements; both were randomized controlled trials (RCTs). Of the 14 studies reporting clinical outcomes, 12 reported improvements (8 were RCTs). Of the 13 studies reporting health care use and spending outcomes, 12 reported significant improvements (2 were RCTs). Two models of care — care and case management and disease management — reported improvements in all 3 outcomes. For care and case management models, most improvements were related to health care use. For the disease management models, most improvements were related to clinical outcomes. Conclusions Care and case management as well as disease management may be promising models of care for people with multiple chronic conditions or disabilities. More research and consistent methods are needed to understand the most appropriate care for these high-need and high-cost patients. PMID:26564013

Systematic Review of Programs Treating High-Need and High-Cost People With Multiple Chronic Diseases or Disabilities in the United States, 2008-2014.

PubMed

Bleich, Sara N; Sherrod, Cheryl; Chiang, Anne; Boyd, Cynthia; Wolff, Jennifer; DuGoff, Eva; Chang, Eva; Salzberg, Claudia; Anderson, Keely; Leff, Bruce; Anderson, Gerard

2015-11-12

Finding ways to provide better and less expensive health care for people with multiple chronic conditions or disability is a pressing concern. The purpose of this systematic review was to evaluate different approaches for caring for this high-need and high-cost population. We searched Medline for articles published from May 31, 2008, through June 10, 2014, for relevant studies. Articles were considered eligible for this review if they met the following criteria: included people with multiple chronic conditions (behavioral or mental health) or disabilities (2 or more); addressed 1 or more of clinical outcomes, health care use and spending, or patient satisfaction; and compared results from an intervention group with a comparison group or baseline measurements. We extracted information on program characteristics, participant characteristics, and significant (positive and negative) clinical findings, patient satisfaction, and health care use outcomes. For each outcome, the number of significant and positive results was tabulated. Twenty-seven studies were included across 5 models of care. Of the 3 studies reporting patient satisfaction outcomes, 2 reported significant improvements; both were randomized controlled trials (RCTs). Of the 14 studies reporting clinical outcomes, 12 reported improvements (8 were RCTs). Of the 13 studies reporting health care use and spending outcomes, 12 reported significant improvements (2 were RCTs). Two models of care - care and case management and disease management - reported improvements in all 3 outcomes. For care and case management models, most improvements were related to health care use. For the disease management models, most improvements were related to clinical outcomes. Care and case management as well as disease management may be promising models of care for people with multiple chronic conditions or disabilities. More research and consistent methods are needed to understand the most appropriate care for these high-need and high-cost patients.

The ICF Core Sets for hearing loss--researcher perspective. Part I: Systematic review of outcome measures identified in audiological research.

PubMed

Granberg, Sarah; Dahlström, Jennie; Möller, Claes; Kähäri, Kim; Danermark, Berth

2014-02-01

To review the literature in order to identify outcome measures used in research on adults with hearing loss (HL) as part of the ICF Core Sets development project, and to describe study and population characteristics of the reviewed studies. A systematic review methodology was applied using multiple databases. A comprehensive search was conducted and two search pools were created, pool I and pool II. The study population included adults (≥ 18 years of age) with HL and oral language as the primary mode of communication. 122 studies were included. Outcome measures were distinguished by 'instrument type', and 10 types were identified. In total, 246 (pool I) and 122 (pool II) different measures were identified, and only approximately 20% were extracted twice or more. Most measures were related to speech recognition. Fifty-one different questionnaires were identified. Many studies used small sample sizes, and the sex of participants was not revealed in several studies. The low prevalence of identified measures reflects a lack of consensus regarding the optimal outcome measures to use in audiology. Reflections and discussions are made in relation to small sample sizes and the lack of sex differentiation/descriptions within the included articles.

Systematic Review: The Effectiveness of Interventions to Reduce Falls and Improve Balance in Adults With Multiple Sclerosis.

PubMed

Gunn, Hilary; Markevics, Sophie; Haas, Bernhard; Marsden, Jonathan; Freeman, Jennifer

2015-10-01

To evaluate the effectiveness of interventions in reducing falls and/or improving balance as a falls risk in multiple sclerosis (MS). Computer-based and manual searches included the following medical subject heading keywords: "Multiple Sclerosis AND accidental falls" OR "Multiple Sclerosis AND postural balance" OR "Multiple Sclerosis AND exercise" OR "Multiple Sclerosis AND physical/physio therapy" NOT animals. All literature published to November 2014 with available full-text details were included. Studies were reviewed against the PICO (participants, interventions, comparisons, outcomes) selection criteria: P, adults with MS; I, falls management/balance rehabilitation interventions; C, randomized/quasi-randomized studies comparing intervention with usual care or placebo control; O, falls outcomes and measures of balance. Fifteen articles of the original 529 search results were included. Two reviewers independently extracted data and assessed methodological quality using the Cochrane Risk of Bias tool. Random-effects meta-analysis indicated a small decrease in falls risk (risk ratio, .74), although the 95% confidence interval (CI) crossed 1 (95% CI, .12-4.38). The pooled standardized mean difference (SMD) for balance outcomes was .55 (95% CI, .35-.74). SMD varied significantly between exercise subgroupings; gait, balance, and functional training interventions yielded the greatest pooled effect size (ES) (SMD=.82; 95% CI, 0.55-1.10). There was a moderate positive correlation between program volume (min/wk) and ES (Cohen's d) (r=.70, P=.009), and a moderate negative correlation between program duration in weeks and ES (r=-.62, P=.03). Variations in interventions and outcomes and methodological limitations mean that results must be viewed with caution. This review suggests that balance may improve through exercise interventions, but that the magnitude of the improvements achieved in existing programs may not be sufficient to impact falls outcomes. Supporting participants to achieve an appropriate intensity of practice of highly challenging balance activities appears to be critical to maximizing effectiveness. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A pilot study to evaluate multi-dimensional effects of dance for people with Parkinson's disease.

PubMed

Ventura, Maria I; Barnes, Deborah E; Ross, Jessica M; Lanni, Kimberly E; Sigvardt, Karen A; Disbrow, Elizabeth A

2016-11-01

Parkinson's disease (PD) is a progressive neurodegenerative disease associated with deficits in motor, cognitive, and emotion/quality of life (QOL) domains, yet most pharmacologic and behavioral interventions focus only on motor function. Our goal was to perform a pilot study of Dance for Parkinson's-a community-based program that is growing in popularity-in order to compare effect sizes across multiple outcomes and to inform selection of primary and secondary outcomes for a larger trial. Study participants were people with PD who self-enrolled in either Dance for Parkinson's classes (intervention group, N=8) or PD support groups (control group, N=7). Assessments of motor function (Timed-Up-and-Go, Gait Speed, Standing Balance Test), cognitive function (Test of Everyday Attention, Verbal Fluency, Alternate Uses, Digit Span Forward and Backward), and emotion/QOL (Geriatric Depression Scale, Falls Efficacy Scale-International, Parkinson's Disease Questionnaire-39 (total score and Activities of Daily Living subscale)) were performed in both groups at baseline and follow-up. Standardized effect sizes were calculated within each group and between groups for all 12 measures. Effect sizes were positive (suggesting improvement) for all 12 measures within the intervention group and 7 of 12 measures within the control group. The largest between-group differences were observed for the Test of Everyday Attention (a measure of cognitive switching), gait speed and falls efficacy. Our findings suggest that dance has potential to improve multiple outcomes in people with PD. Future trials should consider co-primary outcomes given potential benefits in motor, cognitive and emotion/QOL domains. Copyright © 2016 Elsevier Inc. All rights reserved.

Design of the Economic Evaluation for the Interventional Management of Stroke (III) Trial

PubMed Central

Mauldin, Patrick D.; Simpson, Kit N.; Palesch, Yuko Y.; Spilker, Judy S.; Hill, Michael D.; Khatri, Pooja; Broderick, Joseph P.

2011-01-01

SUMMARY Rationale Stroke is a common and costly condition where an effective early reatment may be expected to affect patients’ future quality of life, the cost of acute medical treatment, and the cost of rehabilitation and any supportive care needed for their remaining lifetime. To assist in informing discussions on early adoption of potential treatments, economic analyses should accompany investigations that seek to improve outcomes for stroke patients. Aims The primary aim is to assess whether IV/IA rt-PA therapy is cost-effective at 3 months compared to IV rt-PA, and provides cost-savings or is cost-neutral by 12 months. Design Cost-effectiveness of the two treatment arms will be measured at months 3, 6, 9, and 12. Cost-effectiveness will be calculated using 1) standard cost-effectiveness methodology (Incremental Cost-Effectiveness Ratios), and 2) an econometric model to assess multiple outcome measures while controlling for multiple subject and treatment-related factors that are known to affect both outcomes and costs. Study Outcomes Total cost for the initial hospitalization of treating stroke subjects randomized to either IV/IA or IV rt-PA treatment arms will be measured, as will differences in types of resource utilization over 12 months between the two arms of the trial. Quality-of-life data (EuroQol EQ-5D) will be collected over a 12-month period and quality adjusted life years (QALYs) will be used as a morbidity-adjusted measure of effectiveness. Subgroup analyses will include dichotomized NIH Stroke Scale (<20, ≥20), country, time between onset and randomization, and IA devices. PMID:18706008

A pilot study to evaluate multi-dimensional effects of dance for people with Parkinson’s disease

PubMed Central

Ventura, Maria I.; Barnes, Deborah E.; Ross, Jessica M.; Lanni, Kimberly E.; Sigvardt, Karen A.; Disbrow, Elizabeth A.

2016-01-01

Parkinson’s disease (PD) is a progressive neurodegenerative disease associated with deficits in motor, cognitive, and emotion/quality of life (QOL) domains, yet most pharmacologic and behavioral interventions focus only on motor function. Our goal was to perform a pilot study of Dance for Parkinson’s—a community-based program that is growing in popularity—in order to compare effect sizes across multiple outcomes and to inform selection of primary and secondary outcomes for a larger trial. Study participants were people with PD who self-enrolled in either Dance for Parkinson’s classes (intervention group, N=8) or PD support groups (control group, N=7). Assessments of motor function (Timed-Up-and-Go, Gait Speed, Standing Balance Test), cognitive function (Test of Everyday Attention, Verbal Fluency, Alternate Uses, Digit Span Forward and Backward), and emotion/QOL (Geriatric Depression Scale, Falls Efficacy Scale-International, Parkinson’s Disease Questionnaire-39 (total score and Activities of Daily Living subscale)) were performed in both groups at baseline and follow-up. Standardized effect sizes were calculated within each group and between groups for all 12 measures. Effect sizes were positive (suggesting improvement) for all 12 measures within the intervention group and 7 of 12 measures within the control group. The largest between-group differences were observed for the Test of Everyday Attention (a measure of cognitive switching), gait speed and falls efficacy. Our findings suggest that dance has potential to improve multiple outcomes in people with PD. Future trials should consider co-primary outcomes given potential benefits in motor, cognitive and emotion/QOL domains. PMID:27765693

Behavioral and cognitive outcomes for clinical trials in children with neurofibromatosis type 1.

PubMed

van der Vaart, Thijs; Rietman, André B; Plasschaert, Ellen; Legius, Eric; Elgersma, Ype; Moll, Henriëtte A

2016-01-12

To evaluate the appropriateness of cognitive and behavioral outcome measures in clinical trials in neurofibromatosis type 1 (NF1) by analyzing the degree of deficits compared to reference groups, test-retest reliability, and how scores correlate between outcome measures. Data were analyzed from the Simvastatin for cognitive deficits and behavioral problems in patients with neurofibromatosis type 1 (NF1-SIMCODA) trial, a randomized placebo-controlled trial of simvastatin for cognitive deficits and behavioral problems in children with NF1. Outcome measures were compared with age-specific reference groups to identify domains of dysfunction. Pearson r was computed for before and after measurements within the placebo group to assess test-retest reliability. Principal component analysis was used to identify the internal structure in the outcome data. Strongest mean score deviations from the reference groups were observed for full-scale intelligence (-1.1 SD), Rey Complex Figure Test delayed recall (-2.0 SD), attention problems (-1.2 SD), and social problems (-1.1 SD). Long-term test-retest reliability were excellent for Wechsler scales (r > 0.88), but poor to moderate for other neuropsychological tests (r range 0.52-0.81) and Child Behavioral Checklist subscales (r range 0.40-0.79). The correlation structure revealed 2 strong components in the outcome measures behavior and cognition, with no correlation between these components. Scores on psychosocial quality of life correlate strongly with behavioral problems and less with cognitive deficits. Children with NF1 show distinct deficits in multiple domains. Many outcome measures showed weak test-retest correlations over the 1-year trial period. Cognitive and behavioral outcomes are complementary. This analysis demonstrates the need to include reliable outcome measures on a variety of cognitive and behavioral domains in clinical trials for NF1. © 2015 American Academy of Neurology.

Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

PubMed

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing. The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient. Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects. Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.

Finger and foot tapping as alternative outcomes of upper and lower extremity function in multiple sclerosis.

PubMed

Tanigawa, Makoto; Stein, Jason; Park, John; Kosa, Peter; Cortese, Irene; Bielekova, Bibiana

2017-01-01

While magnetic resonance imaging contrast-enhancing lesions represent an excellent screening tool for disease-modifying treatments in relapsing-remitting multiple sclerosis (RRMS), this biomarker is insensitive for testing therapies against compartmentalized inflammation in progressive multiple sclerosis (MS). Therefore, alternative sensitive outcomes are needed. Using machine learning, clinician-acquired disability scales can be combined with timed measures of neurological functions such as walking speed (e.g. 25-foot walk; 25FW) or fine finger movements (e.g. 9-hole peg test; 9HPT) into sensitive composite clinical scales, such as the recently developed combinatorial, weight-adjusted disability scale (CombiWISE). Ideally, these complementary simplified measurements of certain neurological functions could be performed regularly at patients' homes using smartphones. We asked whether tests amenable to adaptation to smartphone technology, such as finger and foot tapping have comparable sensitivity and specificity to current non-clinician-acquired disability measures. We observed that finger and foot tapping can differentiate RRMS and progressive MS in a cross-sectional study and can also measure yearly and two-year disease progression in the latter, with better power (based on z-scores) in comparison to currently utilized 9HPT and 25FW. Replacing the 9HPT and 25FW with simplified tests broadly adaptable to smartphone technology may enhance the power of composite scales for progressive MS.

Second-trimester maternal serum marker screening: maternal serum alpha-fetoprotein, beta-human chorionic gonadotropin, estriol, and their various combinations as predictors of pregnancy outcome.

PubMed

Yaron, Y; Cherry, M; Kramer, R L; O'Brien, J E; Hallak, M; Johnson, M P; Evans, M I

1999-10-01

We evaluated the value of all 3 common biochemical serum markers, maternal serum alpha-fetoprotein, beta-human chorionic gonadotropin, and unconjugated estriol, and combinations thereof as predictors of pregnancy outcome. A total of 60,040 patients underwent maternal serum screening. All patients had maternal serum alpha-fetoprotein measurements; beta-human chorionic gonadotropin was measured in 45,565 patients, and 24,504 patients had determination of all 3 markers, including unconjugated estriol. The incidences of various pregnancy outcomes were evaluated according to the serum marker levels by using clinically applied cutoff points. In confirmation of previous observations, increased maternal serum alpha-fetoprotein levels (>2.5 multiples of the median) were found to be significantly associated with pregnancy-induced hypertension, miscarriage, preterm delivery, intrauterine growth restriction, intrauterine fetal death, oligohydramnios, and abruptio placentae. Increased beta-human chorionic gonadotropin levels (>2.5 multiples of the median [MoM]) were significantly associated with pregnancy-induced hypertension, miscarriage, preterm delivery, and intrauterine fetal death. Finally, decreased unconjugated estriol levels (<0.5 MoM) were found to be significantly associated with pregnancy-induced hypertension, miscarriage, intrauterine growth restriction, and intrauterine fetal death. As with increased second-trimester maternal serum alpha-fetoprotein levels, increased serum beta-human chorionic gonadotropin and low unconjugated estriol levels are significantly associated with adverse pregnancy outcomes. These are most likely attributed to placental dysfunction. Multiple-marker screening can be used not only for the detection of fetal anomalies and aneu-ploidy but also for detection of high-risk pregnancies.

Alemtuzumab improves quality-of-life outcomes compared with subcutaneous interferon beta-1a in patients with active relapsing-remitting multiple sclerosis.

PubMed

Arroyo González, Rafael; Kita, Mariko; Crayton, Heidi; Havrdova, Eva; Margolin, David H; Lake, Stephen L; Giovannoni, Gavin

2017-09-01

Alemtuzumab was superior on clinical and magnetic resonance imaging (MRI) outcomes versus subcutaneous interferon beta-1a in phase 3 trials in patients with relapsing-remitting multiple sclerosis. To examine quality-of-life (QoL) outcomes in the alemtuzumab phase 3 trials. Patients who were treatment naive (Comparison of Alemtuzumab and Rebif ® Efficacy in Multiple Sclerosis I [CARE-MS I]) or had an inadequate response to prior therapy (CARE-MS II) received annual courses of alemtuzumab 12 mg/day at baseline (5 days) and Month 12 (3 days) or subcutaneous interferon beta-1a 44 µg three times/week. QoL was measured every 6 or 12 months using Functional Assessment of Multiple Sclerosis (FAMS), European Quality of Life-5 Dimensions (EQ-5D) and its visual analog scale (EQ-VAS), and 36-Item Short-Form Survey (SF-36). Statistically significant improvements from baseline with alemtuzumab were observed on all three QoL instruments at the earliest post-baseline assessment and sustained through Year 2. Statistically significant greater QoL improvements over subcutaneous interferon beta-1a were seen at all time points in CARE-MS II with FAMS, EQ-VAS and SF-36 physical component summary, and in CARE-MS I with FAMS. Patients treated with alemtuzumab had improvements in physical, mental, and emotional QoL regardless of treatment history. Improvements were significantly greater with alemtuzumab versus subcutaneous interferon beta-1a on both disease-specific and general measures of QoL.

Web-based physiotherapy for people moderately affected with Multiple Sclerosis; quantitative and qualitative data from a randomized, controlled pilot study.

PubMed

Paul, Lorna; Coulter, Elaine H; Miller, Linda; McFadyen, Angus; Dorfman, Joe; Mattison, Paul George G

2014-09-01

To explore the effectiveness and participant experience of web-based physiotherapy for people moderately affected with Multiple Sclerosis (MS) and to provide data to establish the sample size required for a fully powered, definitive randomized controlled study. A randomized controlled pilot study. Rehabilitation centre and participants' homes. Thirty community dwelling adults moderately affected by MS (Expanded Disability Status Scale 5-6.5). Twelve weeks of individualised web-based physiotherapy completed twice per week or usual care (control). Online exercise diaries were monitored; participants were telephoned weekly by the physiotherapist and exercise programmes altered remotely by the physiotherapist as required. The following outcomes were completed at baseline and after 12 weeks; 25 Foot Walk, Berg Balance Scale, Timed Up and Go, Multiple Sclerosis Impact Scale, Leeds MS Quality of Life Scale, MS-Related Symptom Checklist and Hospital Anxiety and Depression Scale. The intervention group also completed a website evaluation questionnaire and interviews. Participants reported that website was easy to use, convenient, and motivating and would be happy to use in the future. There was no statistically significant difference in the primary outcome measure, the timed 25ft walk in the intervention group (P=0.170), or other secondary outcome measures, except the Multiple Sclerosis Impact Scale (P=0.048). Effect sizes were generally small to moderate. People with MS were very positive about web-based physiotherapy. The results suggested that 80 participants, 40 in each group, would be sufficient for a fully powered, definitive randomized controlled trial. © The Author(s) 2014.

Feasibility and potential effectiveness of a non-pharmacological multidisciplinary care programme for persons with generalised osteoarthritis: a randomised, multiple-baseline single-case study

PubMed Central

Kwakkenbos, Linda; Rietveld, Leonie; den Broeder, Alfons A; de Bie, Rob A; van den Ende, Cornelia H M

2012-01-01

Objectives To evaluate the feasibility and potential effectiveness of a 12-week, non-pharmacological multidisciplinary intervention in patients with generalised osteoarthritis (GOA). Design A randomised, concurrent, multiple-baseline single-case design. During the baseline period, the intervention period and the postintervention period, all participants completed several health outcomes twice a week on Visual Analogue Scales. Setting Rheumatology outpatient department of a specialised hospital in the Netherlands. Participants 1 man and four women (aged 51–76 years) diagnosed with GOA. Primary outcome measures To assess feasibility, the authors assessed the number of dropouts and adverse events, adherence rates and patients' satisfaction. Secondary outcome measures To assess the potential effectiveness, the authors assessed pain and self-efficacy using visual data inspection and randomisation tests. Results The intervention was feasible in terms of adverse events (none) and adherence rate but not in terms of participants' satisfaction with the intervention. Visual inspection of the data and randomisation testing demonstrated no effects on pain (p=0.93) or self-efficacy (p=0.85). Conclusions The results of the present study indicate that the proposed intervention for patients with GOA was insufficiently feasible and effective. The data obtained through this multiple-baseline study have highlighted several areas in which the therapy programme can be optimised. PMID:22815466

Upper Limb Outcome Measures Used in Stroke Rehabilitation Studies: A Systematic Literature Review

PubMed Central

Santisteban, Leire; Térémetz, Maxime; Bleton, Jean-Pierre; Baron, Jean-Claude; Maier, Marc A.; Lindberg, Påvel G.

2016-01-01

Background Establishing which upper limb outcome measures are most commonly used in stroke studies may help in improving consensus among scientists and clinicians. Objective In this study we aimed to identify the most commonly used upper limb outcome measures in intervention studies after stroke and to describe domains covered according to ICF, how measures are combined, and how their use varies geographically and over time. Methods Pubmed, CinHAL, and PeDRO databases were searched for upper limb intervention studies in stroke according to PRISMA guidelines and477 studies were included. Results In studies 48different outcome measures were found. Only 15 of these outcome measures were used in more than 5% of the studies. The Fugl-Meyer Test (FMT)was the most commonly used measure (in 36% of studies). Commonly used measures covered ICF domains of body function and activity to varying extents. Most studies (72%) combined multiple outcome measures: the FMT was often combined with the Motor Activity Log (MAL), the Wolf Motor Function Test and the Action Research Arm Test, but infrequently combined with the Motor Assessment Scale or the Nine Hole Peg Test. Key components of manual dexterity such as selective finger movements were rarely measured. Frequency of use increased over a twelve-year period for the FMT and for assessments of kinematics, whereas other measures, such as the MAL and the Jebsen Taylor Hand Test showed decreased use over time. Use varied largely between countries showing low international consensus. Conclusions The results showed a large diversity of outcome measures used across studies. However, a growing number of studies used the FMT, a neurological test with good psychometric properties. For thorough assessment the FMT needs to be combined with functional measures. These findings illustrate the need for strategies to build international consensus on appropriate outcome measures for upper limb function after stroke. PMID:27152853

Assessing Women’s Preferences and Preference Modeling for Breast Reconstruction Decision Making

PubMed Central

Sun, Clement S.; Cantor, Scott B.; Reece, Gregory P.; Crosby, Melissa A.; Fingeret, Michelle C.

2014-01-01

Background: Women considering breast reconstruction must make challenging trade-offs among issues that often conflict. It may be useful to quantify possible outcomes using a single summary measure to aid a breast cancer patient in choosing a form of breast reconstruction. Methods: In this study, we used multiattribute utility theory to combine multiple objectives to yield a summary value using 9 different preference models. We elicited the preferences of 36 women, aged 32 or older with no history of breast cancer, for the patient-reported outcome measures of breast satisfaction, psychosocial well-being, chest well-being, abdominal well-being, and sexual well-being as measured by the BREAST-Q in addition to time lost to reconstruction and out-of-pocket cost. Participants ranked hypothetical breast reconstruction outcomes. We examined each multiattribute utility preference model and assessed how often each model agreed with participants’ rankings. Results: The median amount of time required to assess preferences was 34 minutes. Agreement among the 9 preference models with the participants ranged from 75.9% to 78.9%. None of the preference models performed significantly worse than the best-performing risk-averse multiplicative model. We hypothesize an average theoretical agreement of 94.6% for this model if participant error is included. There was a statistically significant positive correlation with more unequal distribution of weight given to the 7 attributes. Conclusions: We recommend the risk-averse multiplicative model for modeling the preferences of patients considering different forms of breast reconstruction because it agreed most often with the participants in this study. PMID:25105083

Assessing Adult Exposure to Community Violence: A Review of Definitions and Measures.

PubMed

DeCou, Christopher R; Lynch, Shannon M

2017-01-01

Although experiences of community violence are linked with negative outcomes for adults and children, few standardized measures assessing community violence exist, and available measures lack consistency concerning the definition of community violence. Further, most measures currently utilized to assess adult exposure to community violence were designed for use with children and adolescents. To address these identified concerns and make recommendations for future research, this article reviews contemporary definitions of community violence, identifies the outcomes of exposure to community violence for adults, and evaluates measures of exposure to community violence with published psychometric data employing adult samples. A systematic review of the literature was conducted to identify studies that (1) included a self-report of community violence exposure, (2) included primarily adult respondents, and (3) reported psychometric data. Seventeen studies met the inclusion criteria. Measures employed in these studies were reviewed and basic psychometric properties discussed. Notably, the Survey of Exposure to Community Violence was the most commonly used measure among these studies. Although multiple measures demonstrated limited but acceptable psychometric performance in select studies, few in-depth psychometric analyses exist for measures of adult exposure to community violence. Also, it is difficult to compare studies due to variations in definitions of community violence and multiple versions of each measure. Recommendations for future research include provision of explicit definitions of community violence and reporting psychometric data for measures. © The Author(s) 2015.

Association between length of storage of red blood cell units and outcome of critically ill children: a prospective observational study

PubMed Central

2010-01-01

Introduction Transfusion is a common treatment in pediatric intensive care units (PICUs). Studies in adults suggest that prolonged storage of red blood cell units is associated with worse clinical outcome. No prospective study has been conducted in children. Our objectives were to assess the clinical impact of the length of storage of red blood cell units on clinical outcome of critically ill children. Methods Prospective, observational study conducted in 30 North American centers, in consecutive patients aged <18 years with a stay ≥ 48 hours in a PICU. The primary outcome measure was the incidence of multiple organ dysfunction syndrome after transfusion. The secondary outcomes were 28-day mortality and PICU length of stay. Odds ratios were adjusted for gender, age, number of organ dysfunctions at admission, total number of transfusions, and total dose of transfusion, using a multiple logistic regression model. Results The median length of storage was 14 days in 296 patients with documented length of storage. For patients receiving blood stored ≥ 14 days, the adjusted odds ratio for an increased incidence of multiple organ dysfunction syndrome was 1.87 (95% CI 1.04;3.27, P = 0.03). There was also a significant difference in the total PICU length of stay (adjusted median difference +3.7 days, P < 0.001) and no significant change in mortality. Conclusions In critically ill children, transfusion of red blood cell units stored for ≥ 14 days is independently associated with an increased occurrence of multiple organ dysfunction syndrome and prolonged PICU stay. PMID:20377853

Role of vaccinations as risk factors for ill health in veterans of the Gulf war: cross sectional study

PubMed Central

Hotopf, Matthew; David, Anthony; Hull, Lisa; Ismail, Khalida; Unwin, Catherine; Wessely, Simon

2000-01-01

Objectives To explore the relation between ill health after the Gulf war and vaccines received before or during the conflict. To test the hypothesis that such ill health is limited to military personnel who received multiple vaccines during deployment and that pesticide use modifies any effect. Design Cross sectional study of Gulf war veterans followed for six to eight years after deployment. Setting UK armed forces. Participants Military personnel who served in the Gulf and who still had their vaccine records. Main outcome measures Multisymptom illness as classified by the Centers for Disease Control and Prevention; fatigue; psychological distress; post-traumatic stress reaction; health perception; and physical functioning. Results The response rate for the original survey was 70.4% (n=3284). Of these, 28% (923) had vaccine records. Receipt of multiple vaccines before deployment was associated with only one of the six health outcomes (post-traumatic stress reaction). By contrast five of the six outcomes (all but post-traumatic stress reaction) were associated with multiple vaccines received during deployment. The strongest association was for the multisymptom illness (odds ratio 5.0; 95% confidence interval 2.5 to 9.8). Conclusion Among veterans of the Gulf war there is a specific relation between multiple vaccinations given during deployment and later ill health. Multiple vaccinations in themselves do not seem to be harmful but combined with the “stress” of deployment they may be associated with adverse health outcomes. These results imply that every effort should be made to maintain routine vaccines during peacetime. PMID:10818024

Feasibility, Test-Retest Reliability, and Interrater Reliability of the Modified Ashworth Scale and Modified Tardieu Scale in Persons with Profound Intellectual and Multiple Disabilities

ERIC Educational Resources Information Center

Waninge, A.; Rook, R. A.; Dijkhuizen, A.; Gielen, E.; van der Schans, C. P.

2011-01-01

Caregivers of persons with profound intellectual and multiple disabilities (PIMD) often describe the quality of the daily movements of these persons in terms of flexibility or stiffness. Objective outcome measures for flexibility and stiffness are muscle tone or level of spasticity. Two instruments used to grade muscle tone and spasticity are the…

Gender Differences in the Consequences of Divorce: A Study of Multiple Outcomes.

PubMed

Leopold, Thomas

2018-06-01

In this study, I examined gender differences in the consequences of divorce by tracing annual change in 20 outcome measures covering four domains: economic, housing and domestic, health and well-being, and social. I used data from the German Socio-Economic Panel Study (SOEP) and fixed-effects panel regression models on a sample of N = 18,030 individuals initially observed in a marital union, N = 1,220 of whom divorced across the observation period (1984-2015). Three main findings emerged from the analysis. First, men were more vulnerable to short-term consequences of divorce for subjective measures of well-being, but postdivorce adaptation alleviated gender differences in these outcomes. Second, a medium-term view on multiple outcomes showed more similarity than differences between women and men. The medium-term consequences of divorce were similar in terms of subjective economic well-being; mental health, physical health, and psychological well-being; residential moves, homeownership, and satisfaction with housework; and chances of repartnering, social integration with friends and relatives, and feelings of loneliness. Third, the key domain in which large and persistent gender differences emerged were women's disproportionate losses in household income and associated increases in their risk of poverty and single parenting. Taken together, these findings suggest that men's disproportionate strain of divorce is transient, whereas women's is chronic.

LOW COST, LOW BURDEN, EXPOSURE MONITORING STRATEGIES

EPA Science Inventory

A birth cohort study designed to evaluate the association between exposures to environmental agents and health outcomes presents many challenges for exposure monitoring. Exposure of the child must be measured for multiple chemicals through multiply pathways over an extended peri...

Developing public health performance measures to capture the effects of transportation facilities on multiple public health outcomes.

DOT National Transportation Integrated Search

2016-04-15

Increasingly, federal transportation and public health agencies are working together to identify : transportation investments that improve public health. Investments in transportation : infrastructure represent one method to utilize transportation to...

HEALTH EFFECTS INSTITUTE (2005-2010)

EPA Science Inventory

The center is conducting research in a number of priority areas, including: new approaches to understanding exposure to and health effect of multiple pollutants including particulate matter, gases, and air toxics; measuring health outcomes and benefits resulting from air qu...

HEALTH EFFECTS INSTITUTE (2010-2015)

EPA Science Inventory

The center is conducting research in a number of priority areas, including: new approaches to understanding exposure to and health effect of multiple pollutants )including particulate matter, gases, and air toxics; measuring health outcomes and benefits resulting from air qual...

Province-Level Income Inequality and Health Outcomes in Canadian Adolescents

PubMed Central

McGrath, Jennifer J.

2015-01-01

Objective To examine the effects of provincial income inequality (disparity between rich and poor), independent of provincial income and family socioeconomic status, on multiple adolescent health outcomes. Methods Participants (aged 12–17 years; N = 11,899) were from the Canadian National Longitudinal Survey of Children and Youth. Parental education, household income, province income inequality, and province mean income were measured. Health outcomes were measured across a number of domains, including self-rated health, mental health, health behaviors, substance use behaviors, and physical health. Results Income inequality was associated with injuries, general physical symptoms, and limiting conditions, but not associated with most adolescent health outcomes and behaviors. Income inequality had a moderating effect on family socioeconomic status for limiting conditions, hyperactivity/inattention, and conduct problems, but not for other outcomes. Conclusions Province-level income inequality was associated with some physical and mental health outcomes in adolescents, which has research and policy implications for this age-group. PMID:25324533

A Quantitative Assessment of the Cultural Knowledge, Attitudes, and Experiences of Junior and Senior Dietetics Students

ERIC Educational Resources Information Center

McArthur, Laura H.; Greathouse, Karen R.; Smith, Erskine R.; Holbert, Donald

2011-01-01

Objective: To assess the cultural competence of dietetics majors. Design: Self-administered questionnaire. Setting: Classrooms at 7 universities. Participants: Two hundred eighty-three students--98 juniors (34.6%) and 185 seniors (65.4%)--recruited during class time. Main Outcome Measures: Knowledge was measured using a multiple-choice test,…

Using Multiple Measures to Make Math Placement Decisions: Implications for Access and Success in Community Colleges

ERIC Educational Resources Information Center

Ngo, Federick; Kwon, William W.

2015-01-01

Community college students are often placed in developmental math courses based on the results of a single placement test. However, concerns about accurate placement have recently led states and colleges across the country to consider using other measures to inform placement decisions. While the relationships between college outcomes and such…

Measuring School Climate in High Schools: A Focus on Safety, Engagement, and the Environment

ERIC Educational Resources Information Center

Bradshaw, Catherine P.; Waasdorp, Tracy E.; Debnam, Katrina J.; Johnson, Sarah Lindstrom

2014-01-01

Background: School climate has been linked to multiple student behavioral, academic, health, and social-emotional outcomes. The US Department of Education (USDOE) developed a 3-factor model of school climate comprised of safety, engagement, and environment. This article examines the factor structure and measurement invariance of the USDOE model.…

Curriculum-Based Measurement of Oral Reading: Quality of Progress Monitoring Outcomes

ERIC Educational Resources Information Center

Christ, Theodore J.; Zopluoglu, Cengiz; Long, Jeffery D.; Monaghen, Barbara D.

2012-01-01

Curriculum-based measurement of oral reading (CBM-R) is frequently used to set student goals and monitor student progress. This study examined the quality of growth estimates derived from CBM-R progress monitoring data. The authors used a linear mixed effects regression (LMER) model to simulate progress monitoring data for multiple levels of…

Multiple Measures of Juvenile Drug Court Effectiveness: Results of a Quasi-Experimental Design

ERIC Educational Resources Information Center

Rodriguez, Nancy; Webb, Vincent J.

2004-01-01

Prior studies of juvenile drug courts have been constrained by small samples, inadequate comparison groups, or limited outcome measures. The authors report on a 3-year evaluation that examines the impact of juvenile drug court participation on recidivism and drug use. A quasi-experimental design is used to compare juveniles assigned to drug court…

Predictors of the physical impact of Multiple Sclerosis following community-based, exercise trial.

PubMed

Kehoe, M; Saunders, J; Jakeman, P; Coote, S

2015-04-01

Studies evaluating exercise interventions in people with multiple sclerosis (PwMS) demonstrate small to medium positive effects and large variability on a number of outcome measures. No study to date has tried to explain this variability. This paper presents a novel exploration of data examining the predictors of outcome for PwMS with minimal gait impairment following a randomised, controlled trial evaluating community-based exercise interventions (N = 242). The primary variable was the physical component of the Multiple Sclerosis Impact Scale-29, version 2 (MSIS-29, v2) after a 10-week, controlled intervention period. Predictors were identified a priori and were measured at baseline. Multiple linear regression was conducted. Four models are presented lower MSIS-29, v2 scores after the intervention period were best predicted by a lower baseline MSIS-29,v2, a lower baseline Modified Fatigue Impact Score (physical subscale), randomisation to an exercise intervention, a longer baseline walking distance measured by the Six Minute Walk Test and female gender. This model explained 57.4% of the variance (F (5, 211) = 59.24, p < 0.01). These results suggest that fatigue and walking distance at baseline contribute significantly to predicting MSIS-29, v29 (physical component) after intervention, and thus should be the focus of intervention and assessment. Exercise is an important contributor to minimising the physical impact of MS, and gender-specific interventions may be warranted. © The Author(s), 2014.

Association of Antenatal Corticosteroids with Mortality, Morbidity, and Neurodevelopmental Outcomes in Extremely Preterm Multiple Gestation Infants

PubMed Central

Boghossian, Nansi S.; McDonald, Scott A.; Bell, Edward F.; Carlo, Waldemar A.; Brumbaugh, Jane E.; Stoll, Barbara J.; Laptook, Abbot R.; Shankaran, Seetha; Walsh, Michele C.; Das, Abhik; Higgins, Rosemary D.

2017-01-01

Importance Little is known about the benefits of antenatal corticosteroids on extremely preterm multiples. Objective To examine in extremely preterm multiples if use of antenatal corticosteroids is associated with improvement in major outcomes. Design, Setting, and Participants Infants with gestational age 22–28 weeks born at an NICHD Neonatal Research Network center (1998–2013) were studied. Generalized estimating equation models were used to generate adjusted relative risks (aRR) controlling for important maternal and neonatal variables. Main Outcome Measures In-hospital mortality, the composite outcome of neurodevelopmental impairment at 18–22 months’ corrected age or death before assessment. Results Of 6925 multiple-birth infants, 6094 (88%) were born to women who received antenatal corticosteroids. In-hospital mortality was lower among infants with exposure to antenatal corticosteroids vs no exposure (aRR=0.87, 95% CI 0.78–0.96). Neurodevelopmental impairment or death was not significantly lower among those exposed to antenatal corticosteroids vs no exposure (aRR=0.93, 95% CI 0.84–1.03). Other adverse outcomes that occurred less frequently among infants of women receiving antenatal corticosteroids included severe intraventricular hemorrhage (aRR=0.68, 95% CI 0.58–0.78) and the combined outcomes of necrotizing enterocolitis or death and severe intraventricular hemorrhage or death. Subgroup analyses indicated that exposure to antenatal corticosteroids was associated with a lower risk of mortality and the composite of neurodevelopmental impairment or mortality among non-small for gestational age multiples (aRR=0.82, 95% CI 0.74–0.92 and aRR=0.89, 95% CI 0.80–0.98, respectively) and a higher risk among small for gestational age multiples (aRR=1.40, 95% CI 1.02–1.93 and aRR=1.62, 95% CI 1.22–2.16, respectively). Antenatal corticosteroids were associated with higher neurodevelopmental impairment or mortality among multiple-birth infants of mothers with diabetes (aRR=1.55, 95% CI 1.00–2.38) but not among infants of mothers without diabetes (aRR=0.91, 95% CI 0.83–1.01). Conclusion In extremely preterm multiples, exposure to antenatal corticosteroids compared with no exposure was associated with a lower risk of mortality with no significant differences for the composite of neurodevelopmental impairment or death. Future research should investigate the increased risks of mortality and the composite of neurodevelopmental impairment or death associated with exposure to corticosteroids among small for gestational age multiples. PMID:27088897

Community integration following multidisciplinary rehabilitation for traumatic brain injury.

PubMed

Goranson, Tamara E; Graves, Roger E; Allison, Deborah; La Freniere, Ron

2003-09-01

To determine the extent to which participation in a multidisciplinary rehabilitation programme and patient characteristics predict improvement in community integration following mild-to-moderate traumatic brain injury (TBI). A non-randomized case-control study was conducted employing a pre-test-post-test multiple regression design. Archival data for 42 patients with mild-to-moderate TBI who completed the Community Integration Questionnaire (CIQ) at intake and again 6-18 months later were analysed. Half the sample participated in an intensive outpatient rehabilitation programme that provided multi-modal interventions, while the other half received no rehabilitation. The two groups were matched on age, education and time since injury. On the CIQ Home Integration scale, participation in rehabilitation and female gender predicted better outcome. On the Productivity scale, patients with a lower age at injury had better outcome. Outcome on both of these scales, as well as on the Social Integration scale, was predicted by the baseline pre-test score (initial severity). Overall, multidisciplinary rehabilitation appeared to increase personal independence. It is also concluded that: (1) multivariate analysis can reveal the relative importance of multiple predictors of outcome; (2) different predictors may predict different aspects of outcome; and (3) more sensitive and specific outcome measures are needed.

Pregnancy and oral contraceptive use do not significantly influence outcome in long term rheumatoid arthritis.

PubMed

Drossaers-Bakker, K W; Zwinderman, A H; van Zeben, D; Breedveld, F C; Hazes, J M W

2002-05-01

Oral contraceptives (OC) and pregnancy are known to have an influence on the risk of onset of rheumatoid arthritis (RA). Pregnancy itself has beneficial effects on the activity of the disease, with relapses post partum. It is not known, however, whether OC and pregnancies influence the ultimate outcome of RA. To explore whether OC use and pregnancies influence the 12 year outcome in RA as measured by radiological damage and disability. In a prospective inception cohort of 132 female patients with recent RA according to the 1987 American College of Rheumatology criteria-a cohort initially gathered to study the association between hormonal factors and the onset of RA-outcome was assessed in a follow up after 12 years. The outcome was evaluated in 112 (85%) women by the radiological damage of hands and feet as measured with the Sharp score modification van der Heijde (SHS), the damage of the large joints measured with the Larsen score (LS) of large joints (0-60), and the disability measured with the Health Assessment Questionnaire (HAQ). The median values of each outcome variable were calculated for several subgroups of patients stratified for OC use and pregnancies before and after onset of the disease and the tertiles of the total number of months of OC use and of pregnancies. The association of OC use and pregnancies before and after onset of the disease with the outcome variables was calculated using Spearman's rank correlation (r(s)). The combined influence of OC use and pregnancies on the SHS, LS, and HAQ at 12 years was estimated using ordinal polytomous logistic regression. The median values of the SHS, LS, and HAQ showed a trend towards less radiological joint damage and less disability in women with long term OC use and multiple pregnancies. This difference, however, was not significant, except for the HAQ score in women with three or more pregnancies in life. There was no association between pregnancies, however defined, and any parameter of RA outcome after 12 years (maximum r(s)=-0.10). The only significant correlation was found between OC use before symptom onset and the LS (r(s)=-0.22, p<0.05). The combination of hormonal variables explained no more than a maximum of 3% of the variance of the 12 year outcome as measured by the SHS. OC use and pregnancy do not significantly influence outcome in long term RA. There is, however, a trend for patients with multiple pregnancies and long term OC use to have less radiographic joint damage and a better functional level.

Early Social-Emotional Functioning and Public Health: The Relationship Between Kindergarten Social Competence and Future Wellness.

PubMed

Jones, Damon E; Greenberg, Mark; Crowley, Max

2015-11-01

We examined whether kindergarten teachers' ratings of children's prosocial skills, an indicator of noncognitive ability at school entry, predict key adolescent and adult outcomes. Our goal was to determine unique associations over and above other important child, family, and contextual characteristics. Data came from the Fast Track study of low-socioeconomic status neighborhoods in 3 cities and 1 rural setting. We assessed associations between measured outcomes in kindergarten and outcomes 13 to 19 years later (1991-2000). Models included numerous control variables representing characteristics of the child, family, and context, enabling us to explore the unique contributions among predictors. We found statistically significant associations between measured social-emotional skills in kindergarten and key young adult outcomes across multiple domains of education, employment, criminal activity, substance use, and mental health. A kindergarten measure of social-emotional skills may be useful for assessing whether children are at risk for deficits in noncognitive skills later in life and, thus, help identify those in need of early intervention. These results demonstrate the relevance of noncognitive skills in development for personal and public health outcomes.

Improving the power of an efficacy study of a social and emotional learning program: application of generalizability theory to the measurement of classroom-level outcomes.

PubMed

Mashburn, Andrew J; Downer, Jason T; Rivers, Susan E; Brackett, Marc A; Martinez, Andres

2014-04-01

Social and emotional learning programs are designed to improve the quality of social interactions in schools and classrooms in order to positively affect students' social, emotional, and academic development. The statistical power of group randomized trials to detect effects of social and emotional learning programs and other preventive interventions on setting-level outcomes is influenced by the reliability of the outcome measure. In this paper, we apply generalizability theory to an observational measure of the quality of classroom interactions that is an outcome in a study of the efficacy of a social and emotional learning program called The Recognizing, Understanding, Labeling, Expressing, and Regulating emotions Approach. We estimate multiple sources of error variance in the setting-level outcome and identify observation procedures to use in the efficacy study that most efficiently reduce these sources of error. We then discuss the implications of using different observation procedures on both the statistical power and the monetary costs of conducting the efficacy study.

Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.

PubMed

Gray, Stacy W; Martins, Yolanda; Feuerman, Lindsay Z; Bernhardt, Barbara A; Biesecker, Barbara B; Christensen, Kurt D; Joffe, Steven; Rini, Christine; Veenstra, David; McGuire, Amy L

2014-10-01

The routine use of genomic sequencing in clinical medicine has the potential to dramatically alter patient care and medical outcomes. To fully understand the psychosocial and behavioral impact of sequencing integration into clinical practice, it is imperative that we identify the factors that influence sequencing-related decision making and patient outcomes. In an effort to develop a collaborative and conceptually grounded approach to studying sequencing adoption, members of the National Human Genome Research Institute's Clinical Sequencing Exploratory Research Consortium formed the Outcomes and Measures Working Group. Here we highlight the priority areas of investigation and psychosocial and behavioral outcomes identified by the Working Group. We also review some of the anticipated challenges to measurement in social and behavioral research related to genomic sequencing; opportunities for instrument development; and the importance of qualitative, quantitative, and mixed-method approaches. This work represents the early, shared efforts of multiple research teams as we strive to understand individuals' experiences with genomic sequencing. The resulting body of knowledge will guide recommendations for the optimal use of sequencing in clinical practice.

The use of errorless learning strategies for patients with Alzheimer's disease: a literature review.

PubMed

Li, Ruijie; Liu, Karen P Y

2012-12-01

The aim of this article was to review the evidence of errorless learning on learning outcomes in patients with early-stage Alzheimer's disease. A computer-aided literature search from 1999 to 2011 was carried out using MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and PsycArticles. Keywords included 'errorless learning or practice' and 'Alzheimer's disease'. Four studies that fulfilled the inclusion criteria were selected and reviewed. Two of the studies were clinical controlled trials: one was a single-group pretest-post-test trial and the other was a multiple single-participant study. Demographic variables, design, treatment and outcome measures were summarized. Recall trials were used as the primary outcome measure. Results indicate that the use of errorless learning promotes better retention of specific types of information. Errorless learning is effective in memory rehabilitation of older adults with Alzheimer's disease. However, it would require more studies with unified outcome measures to allow for the formulation of standardized clinical protocol and recommendations.

The HARM score for gastrointestinal surgery: Application and validation of a novel, reliable and simple tool to measure surgical quality and outcomes.

PubMed

Crawshaw, Benjamin P; Keller, Deborah S; Brady, Justin T; Augestad, Knut M; Schiltz, Nicholas K; Koroukian, Siran M; Navale, Suparna M; Steele, Scott R; Delaney, Conor P

2017-03-01

The HospitAl length of stay, Readmissions and Mortality (HARM) score is a simple, inexpensive quality tool, linked directly to patient outcomes. We assess the HARM score for measuring surgical quality across multiple surgical populations. Upper gastrointestinal, hepatobiliary, and colorectal surgery cases between 2005 and 2009 were identified from the Healthcare Cost and Utilization Project California State Inpatient Database. Composite and individual HARM scores were calculated from length of stay, 30-day readmission and mortality, correlated to complication rates for each hospital and stratified by operative type. 71,419 admissions were analyzed. Higher HARM scores correlated with higher complication rates for all cases after risk adjustment and stratification by operation type, elective or emergent status. The HARM score is a simple and valid quality measurement for upper gastrointestinal, hepatobiliary and colorectal surgery. The HARM score could facilitate benchmarking to improve patient outcomes and resource utilization, and may facilitate outcome improvement. Copyright © 2016 Elsevier Inc. All rights reserved.

Job coach factors associated with community-based employment service programme outcome measures for people with disabilities--a Taiwan case study.

PubMed

Yun-Tung, Wang

2010-01-01

The aim of this study is to explore whether/which job coach factors were significantly associated with the community-based employment service (CBES) programme outcome measures in Taiwan. This study used the 2003-2005 CBES programme for People with Disabilities Database in Taipei City in Taiwan (n = 3924) to do a secondary data analysis using hierarchical multiple linear regression. This study found that 'occurrences of the services provided by the job coaches' variable was definitely the dominant predictor and explained additional 19.6% and 27.8% of the variances of annual salary and annual working month outcome measures, respectively. In addition, among six composition variables of 'occurrences of the services provided by the job coaches', 'occurrences of follow-up guidance', 'occurrences of intensive guidance', and 'occurrences of consultation before interviews with employer/director of human resources' were more powerful than the other three in predicting outcomes. Job coach factors in this study were significantly correlated with CBES programme outcome measures for people with disabilities in Taiwan after controlling for the socio-demographic variables. It indicates that the more inputs in the people with disabilities made by job coaches equates to better outcomes in this Taiwan case study.

The SPADE Symptom Cluster in Primary Care Patients With Chronic Pain.

PubMed

Davis, Lorie L; Kroenke, Kurt; Monahan, Patrick; Kean, Jacob; Stump, Timothy E

2016-05-01

Sleep disturbance, pain, anxiety, depression, and low energy/fatigue, the SPADE pentad, are the most prevalent and co-occurring symptoms in the general population and clinical practice. Co-occurrence of SPADE symptoms may produce additive impairment and negatively affect treatment response, potentially undermining patients' health and functioning. The purpose of this paper is to determine: (1) prevalence and comorbidity (ie, clustering) of SPADE symptoms; (2) internal reliability and construct validity of a composite SPADE symptom score derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) measures; and (3) whether improvement in somatic symptom burden represented by a composite score predicted subsequent measures of functional status at 3 and 12 months follow-up. Secondary analysis of data from the Stepped Care to Optimize Pain care Effectiveness study, a randomized trial of a collaborative care intervention for Veterans with chronic pain. Most patients had multiple SPADE symptoms; only 9.6% of patients were monosymptomatic. The composite PROMIS symptom score had good internal reliability (Cronbach's alpha=0.86) and construct validity and strongly correlated with multiple measures of functional status; improvement in the composite score significantly correlated with higher scores for 5 of 6 functional status outcomes. The standardized error of measurement (SEM) for the composite T-score was 2.84, suggesting a 3-point difference in an individual's composite score may be clinically meaningful. Brief PROMIS measures may be useful in evaluating SPADE symptoms and overall symptom burden. Because symptom burden may predict functional status outcomes, better identification and management of comorbid symptoms may be warranted.

From theory to 'measurement' in complex interventions: methodological lessons from the development of an e-health normalisation instrument.

PubMed

Finch, Tracy L; Mair, Frances S; O'Donnell, Catherine; Murray, Elizabeth; May, Carl R

2012-05-17

Although empirical and theoretical understanding of processes of implementation in health care is advancing, translation of theory into structured measures that capture the complex interplay between interventions, individuals and context remain limited. This paper aimed to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring implementation processes relating to e-health interventions; and (2) identify key issues and methodological challenges for advancing work in this field. A 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals. The developed instrument was pre-tested in two professional samples (N=46; N=231). Ratings of items representing normalisation 'processes' were significantly related to staff members' perceptions of whether or not e-health had become 'routine'. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts. To develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.

A mixed-effects regression model for longitudinal multivariate ordinal data.

PubMed

Liu, Li C; Hedeker, Donald

2006-03-01

A mixed-effects item response theory model that allows for three-level multivariate ordinal outcomes and accommodates multiple random subject effects is proposed for analysis of multivariate ordinal outcomes in longitudinal studies. This model allows for the estimation of different item factor loadings (item discrimination parameters) for the multiple outcomes. The covariates in the model do not have to follow the proportional odds assumption and can be at any level. Assuming either a probit or logistic response function, maximum marginal likelihood estimation is proposed utilizing multidimensional Gauss-Hermite quadrature for integration of the random effects. An iterative Fisher scoring solution, which provides standard errors for all model parameters, is used. An analysis of a longitudinal substance use data set, where four items of substance use behavior (cigarette use, alcohol use, marijuana use, and getting drunk or high) are repeatedly measured over time, is used to illustrate application of the proposed model.

Reference values for developing responsive functional outcome measures across the lifespan.

PubMed

McKay, Marnee J; Baldwin, Jennifer N; Ferreira, Paulo; Simic, Milena; Vanicek, Natalie; Burns, Joshua

2017-04-18

To generate a reference dataset of commonly performed functional outcome measures in 1,000 children and adults and investigate the influence of demographic, anthropometric, strength, and flexibility characteristics. Twelve functional outcome measures were collected from 1,000 healthy individuals aged 3-101 years: 6-minute walk test, 30-second chair stand test, timed stairs test, long jump, vertical jump, choice stepping reaction time, balance (Star Excursion Balance Test, tandem stance eyes open and closed, single-leg stance eyes closed), and dexterity (9-hole peg test, Functional Dexterity Test). Correlation and multiple regression analyses were performed to identify factors independently associated with each measure. Age- and sex-stratified reference values for functional outcome measures were generated. Functional performance increased through childhood and adolescence, plateaued during adulthood, and declined in older adulthood. While balance did not differ between the sexes, male participants generally performed better at gross motor tasks while female participants performed better at dexterous tasks. Height was the most consistent correlate of functional performance in children, while lower limb muscle strength was a major determinant in adolescents and adults. In older adults, age, lower limb strength, and joint flexibility explained up to 63% of the variance in functional measures. These normative reference values provide a framework to accurately track functional decline associated with neuromuscular disorders and assist development and validation of responsive outcome measures for therapeutic trials. © 2017 American Academy of Neurology.

Computerised cognitive training in acquired brain injury: A systematic review of outcomes using the International Classification of Functioning (ICF).

PubMed

Sigmundsdottir, Linda; Longley, Wendy A; Tate, Robyn L

2016-10-01

Computerised cognitive training (CCT) is an increasingly popular intervention for people experiencing cognitive symptoms. This systematic review evaluated the evidence for CCT in adults with acquired brain injury (ABI), focusing on how outcome measures used reflect efficacy across components of the International Classification of Functioning, Disability and Health. Database searches were conducted of studies investigating CCT to treat cognitive symptoms in adult ABI. Scientific quality was rated using the PEDro-P and RoBiNT Scales. Ninety-six studies met the criteria. Most studies examined outcomes using measures of mental functions (93/96, 97%); fewer studies included measures of activities/participation (41/96, 43%) or body structures (8/96, 8%). Only 14 studies (15%) provided Level 1 evidence (randomised controlled trials with a PEDro-P score ≥ 6/10), with these studies suggesting strong evidence for CCT improving processing speed in multiple sclerosis (MS) and moderate evidence for improving memory in MS and brain tumour populations. There is a large body of research examining the efficacy of CCT, but relatively few Level 1 studies and evidence is largely limited to body function outcomes. The routine use of outcome measures of activities/participation would provide more meaningful evidence for the efficacy of CCT. The use of body structure outcome measures (e.g., neuroimaging) is a newly emerging area, with potential to increase understanding of mechanisms of action for CCT.

Conditional Spectral Analysis of Replicated Multiple Time Series with Application to Nocturnal Physiology.

PubMed

Krafty, Robert T; Rosen, Ori; Stoffer, David S; Buysse, Daniel J; Hall, Martica H

2017-01-01

This article considers the problem of analyzing associations between power spectra of multiple time series and cross-sectional outcomes when data are observed from multiple subjects. The motivating application comes from sleep medicine, where researchers are able to non-invasively record physiological time series signals during sleep. The frequency patterns of these signals, which can be quantified through the power spectrum, contain interpretable information about biological processes. An important problem in sleep research is drawing connections between power spectra of time series signals and clinical characteristics; these connections are key to understanding biological pathways through which sleep affects, and can be treated to improve, health. Such analyses are challenging as they must overcome the complicated structure of a power spectrum from multiple time series as a complex positive-definite matrix-valued function. This article proposes a new approach to such analyses based on a tensor-product spline model of Cholesky components of outcome-dependent power spectra. The approach exibly models power spectra as nonparametric functions of frequency and outcome while preserving geometric constraints. Formulated in a fully Bayesian framework, a Whittle likelihood based Markov chain Monte Carlo (MCMC) algorithm is developed for automated model fitting and for conducting inference on associations between outcomes and spectral measures. The method is used to analyze data from a study of sleep in older adults and uncovers new insights into how stress and arousal are connected to the amount of time one spends in bed.

Relationship between brain function (aEEG) and brain structure (MRI) and their predictive value for neurodevelopmental outcome of preterm infants.

PubMed

Hüning, Britta; Storbeck, Tobias; Bruns, Nora; Dransfeld, Frauke; Hobrecht, Julia; Karpienski, Julia; Sirin, Selma; Schweiger, Bernd; Weiss, Christel; Felderhoff-Müser, Ursula; Müller, Hanna

2018-05-22

To improve the prediction of neurodevelopmental outcome in very preterm infants, this study used the combination of amplitude-integrated electroencephalography (aEEG) within the first 72 h of life and cranial magnetic resonance imaging (MRI) at term equivalent age. A single-center cohort of 38 infants born before 32 weeks of gestation was subjected to both investigations. Structural measurements were performed on MRI. Multiple regression analysis was used to identify independent factors including functional and structural brain measurements associated with outcome at a corrected age of 24 months. aEEG parameters significantly correlated with MRI measurements. Reduced deep gray matter volume was associated with low Burdjalov Score on day 3 (p < 0.0001) and day 1-3 (p = 0.0012). The biparietal width and the transcerebellar diameter were related to Burdjalov Score on day 1 (p = 0.0111; p = 0.0002). The final multiple regression analysis revealed independent predictors of neurodevelopmental outcome: intraventricular hemorrhage (p = 0.0060) and interhemispheric distance (p = 0.0052) for mental developmental index; Burdjalov Score day 1 (p = 0.0201) and interhemispheric distance (p = 0.0142) for psychomotor developmental index. Functional aEEG parameters were associated with altered brain maturation on MRI. The combination of aEEG and MRI contributes to the prediction of outcome at 24 months. What is Known: • Prematurity remains a risk factor for impaired neurodevelopment. • aEEG is used to measure brain activity in preterm infants and cranial MRI is performed to identify structural gray and white matter abnormalities with impact on neurodevelopmental outcome. What is New: • aEEG parameters observed within the first 72 h of life were associated with altered deep gray matter volumes, biparietal width, and transcerebellar diameter at term equivalent age. • The combination of aEEG and MRI contributes to the prediction of neurodevelopmental outcome at 2 years of corrected age in very preterm infants.

A longitudinal analysis of nursing home outcomes.

PubMed Central

Porell, F; Caro, F G; Silva, A; Monane, M

1998-01-01

OBJECTIVE: To investigate resident and facility attributes associated with long-term care health outcomes in nursing homes. DATA SOURCES: Quarterly Management Minutes Questionnaire (MMQ) survey data for Medicaid case-mix reimbursement of nursing homes in Massachusetts from 1991 to 1994, for specification of outcomes and resident attributes. Facility attributes are specified from cost report data. STUDY DESIGN: Multivariate logistic and "state-dependence" regression models are estimated for survival, ADL functional status, incontinence status, and mental status outcomes from longitudinal residence histories of Medicaid residents spanning 3 to 36 months in length. Outcomes are specified to be a function of resident demographic and diagnostic attributes and facility-level operating and nurse staffing attributes. PRINCIPAL FINDINGS: The estimated parameters for resident demographic and diagnostic attributes showed a great deal of construct validity with respect to clinical expectations regarding risk factors for adverse outcomes. Few facility attributes were associated with outcomes generally, and none was significantly associated with all four outcomes. CONCLUSIONS: The absence of uniform associations between facility attributes and the various long-term care health outcomes studied suggests that strong facility performance on one health outcome may coexist with much weaker performance on other outcomes. This has implications for the aggregation of individual facility performance measures on multiple outcomes and the development of overall outcome performance measures. PMID:9776939

Prediction of IOI-HA scores using speech reception thresholds and speech discrimination scores in quiet.

PubMed

Brännström, K Jonas; Lantz, Johannes; Nielsen, Lars Holme; Olsen, Steen Østergaard

2014-02-01

Outcome measures can be used to improve the quality of the rehabilitation by identifying and understanding which variables influence the outcome. This information can be used to improve outcomes for clients. In clinical practice, pure-tone audiometry, speech reception thresholds (SRTs), and speech discrimination scores (SDSs) in quiet or in noise are common assessments made prior to hearing aid (HA) fittings. It is not known whether SRT and SDS in quiet relate to HA outcome measured with the International Outcome Inventory for Hearing Aids (IOI-HA). The aim of the present study was to investigate the relationship between pure-tone average (PTA), SRT, and SDS in quiet and IOI-HA in both first-time and experienced HA users. SRT and SDS were measured in a sample of HA users who also responded to the IOI-HA. Fifty-eight Danish-speaking adult HA users. The psychometric properties were evaluated and compared to previous studies using the IOI-HA. The associations and differences between the outcome scores and a number of descriptive variables (age, gender, fitted monaurally/binaurally with HA, first-time/experienced HA users, years of HA use, time since last HA fitting, best ear PTA, best ear SRT, or best ear SDS) were examined. A multiple forward stepwise regression analysis was conducted using scores on the separate IOI-HA items, the global score, and scores on the introspection and interaction subscales as dependent variables to examine whether the descriptive variables could predict these outcome measures. Scores on single IOI-HA items, the global score, and scores on the introspection (items 1, 2, 4, and 7) and interaction (items 3, 5, and 6) subscales closely resemble those previously reported. Multiple regression analysis showed that the best ear SDS predicts about 18-19% of the outcome on items 3 and 5 separately, and about 16% on the interaction subscale (sum of items 3, 5, and 6) CONCLUSIONS: The best ears SDS explains some of the variance displayed in the IOI-HA global score and the interaction subscale. The relation between SDS and IOI-HA suggests that a poor unaided SDS might in itself be a limiting factor for the HA rehabilitation efficacy and hence the IOI-HA outcome. The clinician could use this information to align the user's HA expectations to what is within possible reach. American Academy of Audiology.

Results from a prospective acute inpatient rehabilitation database: clinical characteristics and functional outcomes using the Functional Independence Measure.

PubMed

Ng, Yee Sien; Jung, Heeyoune; Tay, San San; Bok, Chek Wai; Chiong, Yi; Lim, Peter A C

2007-01-01

Rehabilitation improves functional outcomes, but there is little data on the profiles and outcomes of patients undergoing inpatient rehabilitation in Singapore. The aims of this paper were to document the clinical characteristics and functional outcomes, using the Functional Independence Measure (FIM), of all patients admitted to an inpatient rehabilitation unit in a tertiary teaching hospital, and to identify and analyse factors significantly associated with better discharge functional scores and higher functional gains. In this prospective cohort study over a 4-year period, clinical and functional data for 1502 patients admitted consecutively to the Singapore General Hospital inpatient rehabilitation unit were charted into a custom-designed rehabilitation database. The primary outcome measures were the discharge total FIM scores, FIM gain and FIM efficiency. Multiple linear regression analysis was used to identify independent variables associated with better discharge FIM scores and FIM gain. The mean age was 61.3 +/- 15.0 years and 57.2% of the patients were male. Stroke (57.9%) followed by spinal cord injury (9.7%) were the most common diagnoses. The average rehabilitation length of stay was 21.5 +/- 19.0 days. The mean admission total FIM score was 70.3 +/- 23.2 and the mean discharge total FIM score was 87.3 +/- 23.0, with this gain being highly significant (P <0.001). The mean FIM gain was 17.0 +/- 13.4 and FIM efficiency was 0.95 +/- 0.90 points/day. Factors associated with better functional outcomes were higher admission motor and cognitive FIM scores, male gender, a longer rehabilitation length of stay and the use of acupuncture. Factors associated with poorer functional outcomes were older age, clinical deconditioning, ischaemic heart disease, depression, pressure sores and the presence of a domestic worker as a caregiver. The FIM is an easy-to-use, standardised and robust general measure of functional disability. Multiple demographic, clinical and socio-cultural variables are associated with the primary functional outcomes and should be taken into account in rehabilitation and discharge planning. Nevertheless, rehabilitation improves functional outcomes across a wide range of diagnoses. Further research should be aimed at evaluating long-term disability postdischarge from inpatient rehabilitation and translating these findings into improving rehabilitation and healthcare resource utilisation.

Predicting Well-being Longitudinally for Mothers Rearing Offspring with Intellectual and Developmental Disabilities

PubMed Central

Grein, Katherine A.; Glidden, Laraine Masters

2014-01-01

Background Well-being outcomes for parents of children with intellectual and developmental disabilities (IDD) may vary from positive to negative at different times and for different measures of well-being. Predicting and explaining this variability has been a major focus of family research for reasons that have both theoretical and applied implications. Methods The current study used data from a 23-year longitudinal investigation of adoptive and birth parents of children with IDD to determine which early child, mother, and family characteristics would predict the variance in maternal outcomes 20 years after their original measurement. Using hierarchical regression analyses, we tested the predictive power of variables measured when children were 7 years old on outcomes of maternal well-being when children were 26 years old. Outcome variables included maternal self-report measures of depression and well–being. Results Final models of well-being accounted for 20% to 34% of variance. For most outcomes, Family Accord and/or the personality variable of Neuroticism (emotional stability/instability) were significant predictors, but some variables demonstrated a different pattern. Conclusions These findings confirm that 1) Characteristics of the child, mother, and family during childhood can predict outcomes of maternal well-being 20 years later; and 2) Different predictor-outcome relationships can vary substantially, highlighting the importance of using multiple measures to gain a more comprehensive understanding of maternal well-being. These results have implications for refining prognoses for parents and for tailoring service delivery to individual child, parent, and family characteristics. PMID:25185956

A systematic review of oral herpetic viral infections in cancer patients: commonly used outcome measures and interventions.

PubMed

Elad, Sharon; Ranna, Vinisha; Ariyawardana, Anura; Correa, Maria Elvira Pizzigatti; Tilly, Vanessa; Nair, Raj G; Rouleau, Tanya; Logan, Richard M; Pinto, Andres; Charette, Veronica; Saunders, Debbie P; Jensen, Siri Beier

2017-02-01

To review the literature for outcome measures for oral viral infections in cancer patients. A secondary aim was to update the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) clinical practice guidelines for the management of oral viral infections in cancer patients. Databases were searched for articles published in the English language, 1981-2013. Studies that met the eligibility criteria were reviewed systematically. The data about the outcome measures were classified according to the aim of the study: prevention, treatment, or non-interventional. The results of interventional studies were compared to the 2010 MASCC/ISOO publication. Multiple clinical and laboratory tests were used to measure oral viral infections, with great variability between studies. Most of the studies were about Herpes Simplex Virus (HSV). The outcome measure that was most commonly used was the presence of HSV infection diagnosed based on a combination of suggestive clinical presentation with a positive laboratory result. HSV culture was the most commonly reported laboratory outcome measure. Acyclovir and valacyclovir were consistently reported to be efficacious in the management of oral herpetic infections. No new data on the quality of life and economic aspects was found. Considering the variability in outcome measures reported to assess oral herpetic infections the researcher should select carefully the appropriate measures based on the objective of the study. Acyclovir and valacyclovir are effective in the management of oral herpetic infections in patients receiving treatment for cancer. Studies on newer anti-viral drugs may be useful to address the issue of anti-viral resistance.

Comparison of Multiple Chronic Obstructive Pulmonary Disease (COPD) Indices in Chinese COPD Patients.

PubMed

Zhang, Jinsong; Miller, Anastasia; Li, Yongxia; Lan, Qinqin; Zhang, Ning; Chai, Yanling; Hai, Bing

2018-04-01

Chronic obstructive pulmonary disease (COPD) is a serious chronic condition with a global impact. Symptoms of COPD include progressive dyspnea, breathlessness, cough, and sputum production, which have a considerable impact on the lives of patients. In addition to the human cost of living with COPD and the resulting death, COPD entails a huge economic burden on the Chinese population, with patients spending up to one-third of the average family income on COPD management in some regions is clinically beneficial to adopt preventable measures via prudent COPD care utilization, monetary costs, and hospitalizations. Toward this end, this study compared the relative effectiveness of six indices in predicting patient healthcare utilization, cost of care, and patient health outcome. The six assessment systems evaluated included the three multidimensional Body mass index, Obstruction, Dyspnea, Exercise capacity index, Dyspnea, Obstruction, Smoking, Exacerbation (DOSE) index, and COPD Assessment Test index, or the unidimensional measures that best predict the future of patient healthcare utilization, cost of care, and patient health outcome among Chinese COPD patients. Multiple linear regression models were created for each healthcare utilization, cost, and outcome including a single COPD index and the same group of demographic variables for each of the outcomes. We conclude that the DOSE index facilitates the prediction of patient healthcare utilization, disease expenditure, and negative clinical outcomes. Our study indicates that the DOSE index has a potential role beyond clinical predictions. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial.

PubMed

van Zijl, Maud D; Koullali, Bouchra; Naaktgeboren, Christiana A; Schuit, Ewoud; Bekedam, Dick J; Moll, Etelka; Oudijk, Martijn A; van Baal, Wilhelmina M; de Boer, Marjon A; Visser, Henricus; van Drongelen, Joris; van de Made, Flip W; Vollebregt, Karlijn C; Muller, Moira A; Bekker, Mireille N; Brons, Jozien T J; Sueters, Marieke; Langenveld, Josje; Franssen, Maureen T; Schuitemaker, Nico W; van Beek, Erik; Scheepers, Hubertina C J; de Boer, Karin; Tepe, Eveline M; Huisjes, Anjoke J M; Hooker, Angelo B; Verheijen, Evelyn C J; Papatsonis, Dimitri N; Mol, Ben Willem J; Kazemier, Brenda M; Pajkrt, Eva

2017-09-04

Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples. Trial registration number: NTR 4414 . Date of registration January 29th 2014.

Life Outcomes and Higher Education: The Need for Longitudinal Research Using a Broad Range of Quality of Life Indicators.

PubMed

Sheppard-Jones, Kathleen; Kleinert, Harold; Butler, Laura; Whaley, Barry

2018-02-01

Higher education is increasingly becoming an option for young adults with intellectual disability (ID). Although initial evaluations of postsecondary education for this population have been promising, a broader "quality of life" framework needs to be adopted in order to truly understand the impact of these programs. Moreover, researchers and program evaluators must collect longitudinal data that follows former students for multiple years and uses multiple measures. We conducted a pilot evaluation of the life outcomes of students who had attended at least two semesters in Kentucky's supported higher education program for students with ID, collecting data on life status and experiences using measures from the National Core Indicators-Adult Consumer Survey. The findings from this pilot study show better outcomes for young adults who participated in a postsecondary education program compared to young adults who did not, but these findings need to be considered in light of several limitations. In many respects, our data provided more new questions than answers. Recommendations for collecting and evaluating broad-based, longitudinal data to gain insight into the potential benefits of postsecondary education for people with intellectual disability are discussed.

Multiple Hypothesis Testing for Experimental Gingivitis Based on Wilcoxon Signed Rank Statistics

PubMed Central

Preisser, John S.; Sen, Pranab K.; Offenbacher, Steven

2011-01-01

Dental research often involves repeated multivariate outcomes on a small number of subjects for which there is interest in identifying outcomes that exhibit change in their levels over time as well as to characterize the nature of that change. In particular, periodontal research often involves the analysis of molecular mediators of inflammation for which multivariate parametric methods are highly sensitive to outliers and deviations from Gaussian assumptions. In such settings, nonparametric methods may be favored over parametric ones. Additionally, there is a need for statistical methods that control an overall error rate for multiple hypothesis testing. We review univariate and multivariate nonparametric hypothesis tests and apply them to longitudinal data to assess changes over time in 31 biomarkers measured from the gingival crevicular fluid in 22 subjects whereby gingivitis was induced by temporarily withholding tooth brushing. To identify biomarkers that can be induced to change, multivariate Wilcoxon signed rank tests for a set of four summary measures based upon area under the curve are applied for each biomarker and compared to their univariate counterparts. Multiple hypothesis testing methods with choice of control of the false discovery rate or strong control of the family-wise error rate are examined. PMID:21984957

Identifying maternal and infant factors associated with newborn size in rural Bangladesh by partial least squares (PLS) regression analysis

PubMed Central

Rahman, Md. Jahanur; Shamim, Abu Ahmed; Klemm, Rolf D. W.; Labrique, Alain B.; Rashid, Mahbubur; Christian, Parul; West, Keith P.

2017-01-01

Birth weight, length and circumferences of the head, chest and arm are key measures of newborn size and health in developing countries. We assessed maternal socio-demographic factors associated with multiple measures of newborn size in a large rural population in Bangladesh using partial least squares (PLS) regression method. PLS regression, combining features from principal component analysis and multiple linear regression, is a multivariate technique with an ability to handle multicollinearity while simultaneously handling multiple dependent variables. We analyzed maternal and infant data from singletons (n = 14,506) born during a double-masked, cluster-randomized, placebo-controlled maternal vitamin A or β-carotene supplementation trial in rural northwest Bangladesh. PLS regression results identified numerous maternal factors (parity, age, early pregnancy MUAC, living standard index, years of education, number of antenatal care visits, preterm delivery and infant sex) significantly (p<0.001) associated with newborn size. Among them, preterm delivery had the largest negative influence on newborn size (Standardized β = -0.29 − -0.19; p<0.001). Scatter plots of the scores of first two PLS components also revealed an interaction between newborn sex and preterm delivery on birth size. PLS regression was found to be more parsimonious than both ordinary least squares regression and principal component regression. It also provided more stable estimates than the ordinary least squares regression and provided the effect measure of the covariates with greater accuracy as it accounts for the correlation among the covariates and outcomes. Therefore, PLS regression is recommended when either there are multiple outcome measurements in the same study, or the covariates are correlated, or both situations exist in a dataset. PMID:29261760

Identifying maternal and infant factors associated with newborn size in rural Bangladesh by partial least squares (PLS) regression analysis.

PubMed

Kabir, Alamgir; Rahman, Md Jahanur; Shamim, Abu Ahmed; Klemm, Rolf D W; Labrique, Alain B; Rashid, Mahbubur; Christian, Parul; West, Keith P

2017-01-01

Birth weight, length and circumferences of the head, chest and arm are key measures of newborn size and health in developing countries. We assessed maternal socio-demographic factors associated with multiple measures of newborn size in a large rural population in Bangladesh using partial least squares (PLS) regression method. PLS regression, combining features from principal component analysis and multiple linear regression, is a multivariate technique with an ability to handle multicollinearity while simultaneously handling multiple dependent variables. We analyzed maternal and infant data from singletons (n = 14,506) born during a double-masked, cluster-randomized, placebo-controlled maternal vitamin A or β-carotene supplementation trial in rural northwest Bangladesh. PLS regression results identified numerous maternal factors (parity, age, early pregnancy MUAC, living standard index, years of education, number of antenatal care visits, preterm delivery and infant sex) significantly (p<0.001) associated with newborn size. Among them, preterm delivery had the largest negative influence on newborn size (Standardized β = -0.29 - -0.19; p<0.001). Scatter plots of the scores of first two PLS components also revealed an interaction between newborn sex and preterm delivery on birth size. PLS regression was found to be more parsimonious than both ordinary least squares regression and principal component regression. It also provided more stable estimates than the ordinary least squares regression and provided the effect measure of the covariates with greater accuracy as it accounts for the correlation among the covariates and outcomes. Therefore, PLS regression is recommended when either there are multiple outcome measurements in the same study, or the covariates are correlated, or both situations exist in a dataset.

Social ecology of child soldiers: child, family, and community determinants of mental health, psychosocial well-being, and reintegration in Nepal.

PubMed

Kohrt, Brandon A; Jordans, Mark J D; Tol, Wietse A; Perera, Em; Karki, Rohit; Koirala, Suraj; Upadhaya, Nawaraj

2010-11-01

This study employed a social ecology framework to evaluate psychosocial well-being in a cross-sectional sample of 142 former child soldiers in Nepal. Outcome measures included the Depression Self Rating Scale (DSRS), Child Posttraumatic Stress Disorder Symptom Scale (CPSS), and locally developed measures of functional impairment and reintegration. Hierarchical linear modeling was used to examine the contribution of factors at multiple levels. At the child level, traumatic exposures, especially torture, predicted poor outcomes, while education improved outcomes. At the family level, conflict-related death of a relative, physical abuse in the household, and loss of wealth during the conflict predicted poor outcomes. At the community level, living in high caste Hindu communities predicted lack of reintegration supports. Ultimately, social ecology is well suited to identify intervention foci across ecological levels based on community differences in vulnerability and protective factors.

Controlled randomised crossover trial of the effects of physiotherapy on mobility in chronic multiple sclerosis

PubMed Central

Wiles, C; Newcombe, R; Fuller, K; Shaw, S; Furnival-Doran, J; Pickersgill, T; Morgan, A

2001-01-01

OBJECTIVES—To determine whether physiotherapy can improve mobility in chronic multiple sclerosis and whether there is a difference between treatment at home and as a hospital outpatient?
METHODS—A randomised controlled crossover trial was undertaken in patients with chronic multiple sclerosis who had difficulty walking and were referred from neurology clinics: allocation was to one of six permutations of three 8 week treatment periods separated by 8 week intervals: treatments consisted of physiotherapy at home, as an outpatient, or "no therapy". The main outcome measures were based on independent assessments at home and included mobility related disability (primary outcome: the Rivermead mobility index), gait impairments, arm function, mood, and subjective patient and carer ratings. Therapy was assessed by recording delivery, achievement of set targets, patient and carer preference, and cost.
RESULTS—On the Rivermead mobility index (scale 0-15) (primary outcome) there was a highly significant (p<0.001) treatment effect of 1.4-1.5 units favouring hospital or home based therapy over no therapy: this was supported by other measures of mobility, gait, balance, and the assessor's global "mobility change" score: there was no major difference between home and hospital. Carers preferred home treatment but neither they nor patients discerned greater benefit there. Estimated costs of home physiotherapy were £25/session and those at hospital were £18 (including £7 patient travel costs).
CONCLUSION—A course of physiotherapy is associated with improved mobility, subjective wellbeing, and improved mood in chronic multiple sclerosis compared with no treatment but benefit may only last a few weeks: there is little to choose between home and hospital based therapy but the first is more costly, mainly due to skilled staff travelling time.

 PMID:11160464

Long-term healthcare costs and functional outcomes associated with lack of remission in schizophrenia: a post-hoc analysis of a prospective observational study

PubMed Central

2012-01-01

Background Little is known about the long-term outcomes for patients with schizophrenia who fail to achieve symptomatic remission. This post-hoc analysis of a 3-year study compared the costs of mental health services and functional outcomes between individuals with schizophrenia who met or did not meet cross-sectional symptom remission at study enrollment. Methods This post-hoc analysis used data from a large, 3-year prospective, non-interventional observational study of individuals treated for schizophrenia in the United States conducted between July 1997 and September 2003. At study enrollment, individuals were classified as non-remitted or remitted using the Schizophrenia Working Group Definition of symptom remission (8 core symptoms rated as mild or less). Mental health service use was measured using medical records. Costs were based on the sites’ medical information systems. Functional outcomes were measured with multiple patient-reported measures and the clinician-rated Quality of Life Scale (QLS). Symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Outcomes for non-remitted and remitted patients were compared over time using mixed effects models for repeated measures or generalized estimating equations after adjusting for multiple baseline characteristics. Results At enrollment, most of the 2,284 study participants (76.1%) did not meet remission criteria. Non-remitted patients had significantly higher PANSS total scores at baseline, a lower likelihood of being Caucasian, a higher likelihood of hospitalization in the previous year, and a greater likelihood of a substance use diagnosis (all p < 0.05). Total mental health costs were significantly higher for non-remitted patients over the 3-year study (p = 0.008). Non-remitted patients were significantly more likely to be victims of crime, exhibit violent behavior, require emergency services, and lack paid employment during the 3-year study (all p < 0.05). Non-remitted patients also had significantly lower scores on the QLS, SF-12 Mental Component Summary Score, and Global Assessment of Functioning during the 3-year study. Conclusions In this post-hoc analysis of a 3-year prospective observational study, the failure to achieve symptomatic remission at enrollment was associated with higher subsequent healthcare costs and worse functional outcomes. Further examination of outcomes for schizophrenia patients who fail to achieve remission at initial assessment by their subsequent clinical status is warranted. PMID:23216976

The Health Action Process Approach as a motivational model for physical activity self-management for people with multiple sclerosis: a path analysis.

PubMed

Chiu, Chung-Yi; Lynch, Ruth T; Chan, Fong; Berven, Norman L

2011-08-01

To evaluate the Health Action Process Approach (HAPA) as a motivational model for physical activity self-management for people with multiple sclerosis (MS). Quantitative descriptive research design using path analysis. One hundred ninety-five individuals with MS were recruited from the National Multiple Sclerosis Society and a neurology clinic at a university teaching hospital in the Midwest. Outcome was measured by the Physical Activity Stages of Change Instrument, along with measures for nine predictors (severity, action self-efficacy, outcome expectancy, risk perception, perceived barriers, intention, maintenance self-efficacy, action and coping planning, and recovery self-efficacy). The respecified HAPA physical activity model fit the data relatively well (goodness-of-fit index = .92, normed fit index = .91, and comparative fit index = .93) explaining 38% of the variance in physical activity. Recovery self-efficacy, action and coping planning, and perceived barriers directly contributed to the prediction of physical activity. Outcome expectancy significantly influenced intention and the relationship between intention and physical activity is mediated by action and coping planning. Action self-efficacy, maintenance self-efficacy, and recovery self-efficacy directly or indirectly affected physical activity. Severity of MS and action self-efficacy had an inverse relationship with perceived barriers and perceived barriers influenced physical activity. Empirical support was found for the proposed HAPA model of physical activity for people with MS. The HAPA model appears to provide useful information for clinical rehabilitation and health promotion interventions.

Measuring ability to assess claims about treatment effects: a latent trait analysis of items from the ‘Claim Evaluation Tools’ database using Rasch modelling

PubMed Central

Austvoll-Dahlgren, Astrid; Guttersrud, Øystein; Nsangi, Allen; Semakula, Daniel; Oxman, Andrew D

2017-01-01

Background The Claim Evaluation Tools database contains multiple-choice items for measuring people’s ability to apply the key concepts they need to know to be able to assess treatment claims. We assessed items from the database using Rasch analysis to develop an outcome measure to be used in two randomised trials in Uganda. Rasch analysis is a form of psychometric testing relying on Item Response Theory. It is a dynamic way of developing outcome measures that are valid and reliable. Objectives To assess the validity, reliability and responsiveness of 88 items addressing 22 key concepts using Rasch analysis. Participants We administrated four sets of multiple-choice items in English to 1114 people in Uganda and Norway, of which 685 were children and 429 were adults (including 171 health professionals). We scored all items dichotomously. We explored summary and individual fit statistics using the RUMM2030 analysis package. We used SPSS to perform distractor analysis. Results Most items conformed well to the Rasch model, but some items needed revision. Overall, the four item sets had satisfactory reliability. We did not identify significant response dependence between any pairs of items and, overall, the magnitude of multidimensionality in the data was acceptable. The items had a high level of difficulty. Conclusion Most of the items conformed well to the Rasch model’s expectations. Following revision of some items, we concluded that most of the items were suitable for use in an outcome measure for evaluating the ability of children or adults to assess treatment claims. PMID:28550019

Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.

PubMed

Faraj, Sayf S A; van Hooff, Miranda L; Holewijn, Roderick M; Polly, David W; Haanstra, Tsjitske M; de Kleuver, Marinus

2017-08-01

Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD. Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated. The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD. Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.

Clinical trials in progressive multiple sclerosis: lessons learned and future perspectives

PubMed Central

Ontaneda, Daniel; Fox, Robert J.; Chataway, Jeremy

2015-01-01

Progressive multiple sclerosis is characterized by the gradual accrual of disability independent of relapses and can occur with disease onset (primary progressive) or preceded by a relapsing disease course (secondary progressive). An effective disease modifying treatment for progressive multiple sclerosis has not been identified, and the results of clinical trials to date have been generally disappointing. Ongoing advances in our understanding of pathogenesis, identification of novel targets for neuro-protection, and improved outcome measures have the potential to lead to effective treatments for progressive multiple sclerosis. In this review lessons learned from previous clinical trials and perspectives from current trials in progressive multiple sclerosis are summarized. Promising clinical, imaging, and biological markers will also be reviewed, along with novel clinical trial designs. PMID:25772899

Self-Management for People with Multiple Sclerosis

PubMed Central

Fraser, Robert; Ehde, Dawn; Amtmann, Dagmar; Johnson, Kurt L.; Johnson, Erica; Kraft, George H.

2013-01-01

People with multiple sclerosis (MS) must manage the day-to-day effects of the disease on their lives. Self-management interventions may be helpful in this challenge. An international, multidisciplinary consensus conference was held on November 15, 2010, by the University of Washington's Rehabilitation Research and Training Center for Multiple Sclerosis (MS RRTC), with funding from the Consortium of Multiple Sclerosis Centers (CMSC) and the National Institute on Disability and Rehabilitation Research (NIDRR), to discuss the concept of self-management for people with MS. The specific goals of the consensus conference were as follows: 1) review the current research on self-management and related issues in chronic disability and specifically in MS; 2) review optimal research methodologies, outcome measurement tools, program planning frameworks, and dissemination strategies for self-management research; and 3) establish recommendations on the next steps necessary to develop, adapt, and test self-management interventions for people with MS. The consensus conference and this document are the initial steps toward achieving the stated goals. Participants in the consensus conference concluded that it is necessary to: 1) define an empirically based conceptual model of self-management for people with MS; 2) establish reliable and valid self-management outcome measures; 3) use best practices to validate models of self-management interventions; and 4) plan dissemination and knowledge translation of interventions once their effectiveness is established. PMID:24453769

The Relationship Between Provider Competence, Content Exposure, and Consumer Outcomes in Illness Management and Recovery Programs.

PubMed

McGuire, Alan B; White, Dominique A; Bartholomew, Tom; Flanagan, Mindy E; McGrew, John H; Rollins, Angela L; Mueser, Kim T; Salyers, Michelle P

2017-01-01

Provider competence may affect the impact of a practice. The current study examined this relationship in sixty-three providers engaging in Illness Management and Recovery with 236 consumers. Improving upon previous research, the present study utilized a psychometrically validated competence measure in the ratings of multiple Illness Management and Recovery sessions from community providers, and mapped outcomes onto the theory underlying the practice. Provider competence was positively associated with illness self-management and adaptive coping. Results also indicated baseline self-management skills and working alliance may affect the relationship between competence and outcomes.

Statistical Power in Evaluations That Investigate Effects on Multiple Outcomes: A Guide for Researchers

ERIC Educational Resources Information Center

Porter, Kristin E.

2018-01-01

Researchers are often interested in testing the effectiveness of an intervention on multiple outcomes, for multiple subgroups, at multiple points in time, or across multiple treatment groups. The resulting multiplicity of statistical hypothesis tests can lead to spurious findings of effects. Multiple testing procedures (MTPs) are statistical…

Estimation of health effects of prenatal methylmercury exposure using structural equation models.

PubMed

Budtz-Jørgensen, Esben; Keiding, Niels; Grandjean, Philippe; Weihe, Pal

2002-10-14

Observational studies in epidemiology always involve concerns regarding validity, especially measurement error, confounding, missing data, and other problems that may affect the study outcomes. Widely used standard statistical techniques, such as multiple regression analysis, may to some extent adjust for these shortcomings. However, structural equations may incorporate most of these considerations, thereby providing overall adjusted estimations of associations. This approach was used in a large epidemiological data set from a prospective study of developmental methyl-mercury toxicity. Structural equation models were developed for assessment of the association between biomarkers of prenatal mercury exposure and neuropsychological test scores in 7 year old children. Eleven neurobehavioral outcomes were grouped into motor function and verbally mediated function. Adjustment for local dependence and item bias was necessary for a satisfactory fit of the model, but had little impact on the estimated mercury effects. The mercury effect on the two latent neurobehavioral functions was similar to the strongest effects seen for individual test scores of motor function and verbal skills. Adjustment for contaminant exposure to poly chlorinated biphenyls (PCBs) changed the estimates only marginally, but the mercury effect could be reduced to non-significance by assuming a large measurement error for the PCB biomarker. The structural equation analysis allows correction for measurement error in exposure variables, incorporation of multiple outcomes and incomplete cases. This approach therefore deserves to be applied more frequently in the analysis of complex epidemiological data sets.

Effects of Multidisciplinary Rehabilitation on Chronic Fatigue in Multiple Sclerosis: A Randomized Controlled Trial

PubMed Central

Rietberg, Marc B.; van Wegen, Erwin E. H.; Eyssen, Isaline C. J. M.; Kwakkel, Gert

2014-01-01

Background Several rehabilitation programmes aim at reducing the impact of fatigue in MS patients. Acute and chronic fatigue should require different management. Objectives To assess the effects of individually tailored, multidisciplinary outpatient rehabilitation (MDR) on chronic fatigue. Methods Forty-eight ambulatory MS patients with chronic fatigue were randomized to MDR or to MS–nurse consultation. Fatigue was assessed by the Checklist Individual Strength (CIS-20R). Secondary outcomes included the Modified Fatigue Impact Scale, Fatigue Severity Scale, Functional Independence Measure, Disability and Impact Profile (DIP), Multiple Sclerosis Impact Scale and the Impact on Participation and Autonomy (IPA). Results The primary outcome measure CIS-20R overall score showed no significant differences between groups at 12 weeks (P = 0.39) and 24 weeks follow-up (P = 0.14), nor for subscales (t = 12 and t = 24, 0.19≤P≤0.88). No significant within-group effects were found for both groups with respect to the primary (0.57≤p≤0.97) and secondary (0.11≤p≤0.92) outcome measures from baseline to 12 or 24 weeks. Conclusion Multidisciplinary rehabilitation was not more effective in terms of reducing self-reported fatigue in MS patients compared to MS-nurse consultation. Our results suggest that chronic fatigue in patients with MS may be highly invariant over time, irrespective of interventions. Trial Registration controlled-trials.com ISRCTN05017507 PMID:25232955

The impact of prison reentry services on short-term outcomes: evidence from a multisite evaluation.

PubMed

Lattimore, Pamela K; Visher, Christy A

2013-01-01

Renewed interest in prisoner rehabilitation to improve postrelease outcomes occurred in the 1990s, as policy makers reacted to burgeoning prison populations with calls to facilitate community reintegration and reduce recidivism. In 2003, the Federal government funded grants to implement locally designed reentry programs. Adult programs in 12 states were studied to determine the effects of the reentry programs on multiple outcomes. A two-stage matching procedure was used to examine the effectiveness of 12 reentry programs for adult males. In the first stage, "intact group matching" was used to identify comparison populations that were similar to program participants. In the second stage, propensity score matching was used to adjust for remaining differences between groups. Propensity score weighted logistic regression was used to examine the impact of reentry program participation on multiple outcomes measured 3 months after release. The study population was 1,697 adult males released from prisons in 2004-2005. Data consisted of interview data gathered 30 days prior to release and approximately 3 months following release, supplemented by administrative data from state departments of correction and the National Crime Information Center. Results suggest programs increased in-prison service receipt and produced modest positive outcomes across multiple domains (employment, housing, and substance use) 3 months after release. Although program participants reported fewer crimes, differences in postrelease arrest and reincarceration were not statistically significant. Incomplete implementation and service receipt by comparison group members may have resulted in insufficient statistical power to identify stronger treatment effects.

Establishing Long-Term Efficacy in Chronic Disease: Use of Recursive Partitioning and Propensity Score Adjustment to Estimate Outcome in MS

PubMed Central

Goodin, Douglas S.; Jones, Jason; Li, David; Traboulsee, Anthony; Reder, Anthony T.; Beckmann, Karola; Konieczny, Andreas; Knappertz, Volker

2011-01-01

Context Establishing the long-term benefit of therapy in chronic diseases has been challenging. Long-term studies require non-randomized designs and, thus, are often confounded by biases. For example, although disease-modifying therapy in MS has a convincing benefit on several short-term outcome-measures in randomized trials, its impact on long-term function remains uncertain. Objective Data from the 16-year Long-Term Follow-up study of interferon-beta-1b is used to assess the relationship between drug-exposure and long-term disability in MS patients. Design/Setting To mitigate the bias of outcome-dependent exposure variation in non-randomized long-term studies, drug-exposure was measured as the medication-possession-ratio, adjusted up or down according to multiple different weighting-schemes based on MS severity and MS duration at treatment initiation. A recursive-partitioning algorithm assessed whether exposure (using any weighing scheme) affected long-term outcome. The optimal cut-point that was used to define “high” or “low” exposure-groups was chosen by the algorithm. Subsequent to verification of an exposure-impact that included all predictor variables, the two groups were compared using a weighted propensity-stratified analysis in order to mitigate any treatment-selection bias that may have been present. Finally, multiple sensitivity-analyses were undertaken using different definitions of long-term outcome and different assumptions about the data. Main Outcome Measure Long-Term Disability. Results In these analyses, the same weighting-scheme was consistently selected by the recursive-partitioning algorithm. This scheme reduced (down-weighted) the effectiveness of drug exposure as either disease duration or disability at treatment-onset increased. Applying this scheme and using propensity-stratification to further mitigate bias, high-exposure had a consistently better clinical outcome compared to low-exposure (Cox proportional hazard ratio = 0.30–0.42; p<0.0001). Conclusions Early initiation and sustained use of interferon-beta-1b has a beneficial impact on long-term outcome in MS. Our analysis strategy provides a methodological framework for bias-mitigation in the analysis of non-randomized clinical data. Trial Registration Clinicaltrials.gov NCT00206635 PMID:22140424

Religion, Poverty, and Politics: Their Impact on Women's Reproductive Health Outcomes.

PubMed

Kimball, Richard; Wissner, Michael

2015-01-01

This study sought to explore the relationship(s) between U.S. states of selected social determinants of health (SDH) and three women's reproductive health outcomes including abortion, teen births, and infant mortality rates (IMR). The data from multiple population surveys were used to establish on a state-by-state basis, the interactions between selected SDH (religion, voting patterns, child poverty, and GINI) and their policy effects on three women's reproductive health outcomes (abortion, teen births, and IMRs) using publicly available national databases. Child poverty rates and the GINI coefficient were analyzed. Religiosity information was obtained from the Pew Forum's surveys. Voting results were collected from the 2008 congressional and presidential races and were used as proxy measures for conservative- versus liberal-leaning policies and policy makers. Using multiple regression analysis, higher IMRs were associated with higher religiosity scores. Lower abortion rates were associated with voting conservatively and higher income inequality. Higher teen birth rates were associated with higher child poverty rates and voting conservatively. This study shows that selected SDH may have substantial impacts on women's reproductive health outcomes at the state level. Significant inequalities exist between liberal and conservative states that affect women's health outcomes. © 2015 Wiley Periodicals, Inc.

Using agent-based modeling to study multiple risk factors and multiple health outcomes at multiple levels.

PubMed

Yang, Yong

2017-11-01

Most health studies focus on one health outcome and examine the influence of one or multiple risk factors. However, in reality, various pathways, interactions, and associations exist not only between risk factors and health outcomes but also among the risk factors and among health outcomes. The advance of system science methods, Big Data, and accumulated knowledge allows us to examine how multiple risk factors influence multiple health outcomes at multiple levels (termed a 3M study). Using the study of neighborhood environment and health as an example, I elaborate on the significance of 3M studies. 3M studies may lead to a significantly deeper understanding of the dynamic interactions among risk factors and outcomes and could help us design better interventions that may be of particular relevance for upstream interventions. Agent-based modeling (ABM) is a promising method in the 3M study, although its potentials are far from being fully explored. Future challenges include the gap of epidemiologic knowledge and evidence, lack of empirical data sources, and the technical challenges of ABM. © 2017 New York Academy of Sciences.

Factors associated with reduced functional outcome and quality of life in patients having limb-sparing surgery for soft tissue sarcomas - a national multicenter study of 128 patients.

PubMed

Saebye, Casper; Fugloe, Hanna M; Nymark, Tine; Safwat, Akmal; Petersen, Michael M; Baad-Hansen, Thomas; Krarup-Hansen, Anders; Keller, Johnny

2017-02-01

Limb-sparing surgery for sarcomas has become possible in most cases. However, the impact of the procedure on the functional outcome has only been investigated in a few studies. The aim of this study has been to identify tumor- and patient-related factors associated with reduced functional outcome and quality of life after limb-sparing surgery in soft tissue sarcoma patients. In total, 128 patients (mean age = 58, female/male = 54/74) who were treated with limb-sparing surgery without bone resection for soft tissue sarcomas in Denmark during the period 1 January 2009 to 31 December 2011 were included. Patients were asked to participate at least one year after surgery, and patients who had experienced local recurrence or metastatic disease were excluded. The Toronto Extremity Salvage Score (TESS) measured functional disability, while the Musculoskeletal Tumor Society Score (MSTS) measured functional impairment. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 measured quality of life. Tumor- and patient-related factors (age, gender, tumor depth, tumor size, malignancy, comorbidity, location, and radiotherapy) were extracted from the Danish National Sarcoma Database. Wilcoxon rank-sum test and Kruskal-Wallis were used for univariable analysis. Adjusted odds ratios were estimated by using multiple logistic regression models. In the multiple regression analysis, it was found that female gender (p = 0.03), lower extremity tumors (p < 0.01) and radiotherapy (p = 0.02) resulted in an increased risk of a lower TESS score. Initial reduced postoperative function was found to be associated with a lower functional outcome. Patients with reduced functional outcome have increased risk for reduced quality of life (p < 0.01). The results of this study show that patient- and tumor-related factors have an important role in the functional outcome.

Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial

PubMed Central

Sørensen, Jette Led; van der Vleuten, Cees; Rosthøj, Susanne; Østergaard, Doris; LeBlanc, Vicki; Johansen, Marianne; Ekelund, Kim; Starkopf, Liis; Lindschou, Jane; Gluud, Christian; Weikop, Pia; Ottesen, Bent

2015-01-01

Objective To investigate the effect of in situ simulation (ISS) versus off-site simulation (OSS) on knowledge, patient safety attitude, stress, motivation, perceptions of simulation, team performance and organisational impact. Design Investigator-initiated single-centre randomised superiority educational trial. Setting Obstetrics and anaesthesiology departments, Rigshospitalet, University of Copenhagen, Denmark. Participants 100 participants in teams of 10, comprising midwives, specialised midwives, auxiliary nurses, nurse anaesthetists, operating theatre nurses, and consultant doctors and trainees in obstetrics and anaesthesiology. Interventions Two multiprofessional simulations (clinical management of an emergency caesarean section and a postpartum haemorrhage scenario) were conducted in teams of 10 in the ISS versus the OSS setting. Primary outcome Knowledge assessed by a multiple choice question test. Exploratory outcomes Individual outcomes: scores on the Safety Attitudes Questionnaire, stress measurements (State-Trait Anxiety Inventory, cognitive appraisal and salivary cortisol), Intrinsic Motivation Inventory and perceptions of simulations. Team outcome: video assessment of team performance. Organisational impact: suggestions for organisational changes. Results The trial was conducted from April to June 2013. No differences between the two groups were found for the multiple choice question test, patient safety attitude, stress measurements, motivation or the evaluation of the simulations. The participants in the ISS group scored the authenticity of the simulation significantly higher than did the participants in the OSS group. Expert video assessment of team performance showed no differences between the ISS versus the OSS group. The ISS group provided more ideas and suggestions for changes at the organisational level. Conclusions In this randomised trial, no significant differences were found regarding knowledge, patient safety attitude, motivation or stress measurements when comparing ISS versus OSS. Although participant perception of the authenticity of ISS versus OSS differed significantly, there were no differences in other outcomes between the groups except that the ISS group generated more suggestions for organisational changes. Trial registration number NCT01792674. PMID:26443654

Orthodontic trial outcomes: Plentiful, inconsistent, and in need of uniformity? A scoping review.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Fleming, Padhraig S

2018-06-01

The selection of appropriate outcomes that matter to both patients and operators is increasingly appreciated, with core outcome sets in clinical trials gaining in popularity. The first step in core outcome set development is the generation of a list of possible important outcomes based on a scoping literature review. Moreover, outcome heterogeneity is known to detract from the findings of systematic reviews and meta-analyses. The aim of this study was to identify the range of outcome domains and specific outcome measures in contemporary orthodontic research. Multiple electronic databases were searched from December 31, 2012, to December 31, 2016, to identify clinical trials of orthodontic interventions, with no language restrictions. Abstracts, eligible full texts, and reference lists were screened, and all reported primary and nonprimary outcomes and methods of measurement were recorded. The search identified 1267 abstracts, of which 189 full-text articles were retrieved, and 164 studies were included in the analysis. A total of 54 outcomes were identified and categorized into 14 outcome domains. The most frequently measured outcomes were patient-reported pain, periodontal health, tooth angulation/inclination changes, and treatment duration, followed by rate of tooth movement and skeletal changes. Outcomes that followed the overall course of treatment were assessed in only 14 studies. Patient perspectives are increasingly being accounted for in orthodontic trials; however, there is little consistency in outcome selection among them. The identified list of outcomes will be used to inform a ranking exercise with service users and providers to establish an agreed core outcome set for future orthodontic clinical trials. Copyright © 2018 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Modeling Learning in Doubly Multilevel Binary Longitudinal Data Using Generalized Linear Mixed Models: An Application to Measuring and Explaining Word Learning.

PubMed

Cho, Sun-Joo; Goodwin, Amanda P

2016-04-01

When word learning is supported by instruction in experimental studies for adolescents, word knowledge outcomes tend to be collected from complex data structure, such as multiple aspects of word knowledge, multilevel reader data, multilevel item data, longitudinal design, and multiple groups. This study illustrates how generalized linear mixed models can be used to measure and explain word learning for data having such complexity. Results from this application provide deeper understanding of word knowledge than could be attained from simpler models and show that word knowledge is multidimensional and depends on word characteristics and instructional contexts.

A personalized, intense physical rehabilitation program improves walking in people with multiple sclerosis presenting with different levels of disability: a retrospective cohort.

PubMed

Kalron, Alon; Nitzani, Dalia; Magalashvili, David; Dolev, Mark; Menascu, Shay; Stern, Yael; Rosenblum, Uri; Pasitselsky, Diana; Frid, Lior; Zeilig, Gabi; Barmatz, Caroline; Givon, Uri; Achiron, Anat

2015-03-04

People with multiple sclerosis (PwMS) endure walking limitations. To address this restriction, various physical rehabilitation programs have been implemented with no consensus regarding their efficacy. Our objective was to report on the efficacy of an integrated tailored physical rehabilitation program on walking in people with multiple sclerosis categorized according to their level of neurological disability. Retrospective data were examined and analyzed. Specifically, data obtained from all patients who participated in the Multiple Sclerosis Center's 3 week rehabilitation program were extracted for in depth exploration. The personalized rehabilitation program included three major components modified according to the patient's specific impairments and functional needs: (a) goal directed physical therapy (b) moderately intense aerobic exercise training on a bicycle ergometer and (c) aquatic therapy chiefly oriented to body structures appropriate to movement. Gait outcome measurements included the 10 meter, 20 meter, Timed up and go and 2 minute walking tests measured pre and post the rehabilitation program. Three hundred and twelve people with relapsing-remitting multiple sclerosis were included in the final analysis. Patients were categorized into mild (n = 87), moderate (n = 104) and severely (n = 121) disabled groups. All clinical walking outcome measurements demonstrated statistically significant improvements, however, only an increase in the 2 minute walking test was above the minimal clinical difference value. The moderate and severe groups considerably improved compared to the mild gait disability group. Mean change scores (%) of the pre-post intervention period of the 2 minute walking test were 19.0 (S.E. = 3.4) in the moderate group, 16.2 (S.E. = 5.4) in the severe group and 10.9 (S.E. = 2.3) in the mild gait disability group. We presented comprehensive evidence verifying the effects of an intense goal-directed physical rehabilitation program on ambulation in people with multiple sclerosis presenting with different neurological impairment levels.

Improving the Rank Precision of Population Health Measures for Small Areas with Longitudinal and Joint Outcome Models

PubMed Central

Athens, Jessica K.; Remington, Patrick L.; Gangnon, Ronald E.

2015-01-01

Objectives The University of Wisconsin Population Health Institute has published the County Health Rankings since 2010. These rankings use population-based data to highlight health outcomes and the multiple determinants of these outcomes and to encourage in-depth health assessment for all United States counties. A significant methodological limitation, however, is the uncertainty of rank estimates, particularly for small counties. To address this challenge, we explore the use of longitudinal and pooled outcome data in hierarchical Bayesian models to generate county ranks with greater precision. Methods In our models we used pooled outcome data for three measure groups: (1) Poor physical and poor mental health days; (2) percent of births with low birth weight and fair or poor health prevalence; and (3) age-specific mortality rates for nine age groups. We used the fixed and random effects components of these models to generate posterior samples of rates for each measure. We also used time-series data in longitudinal random effects models for age-specific mortality. Based on the posterior samples from these models, we estimate ranks and rank quartiles for each measure, as well as the probability of a county ranking in its assigned quartile. Rank quartile probabilities for univariate, joint outcome, and/or longitudinal models were compared to assess improvements in rank precision. Results The joint outcome model for poor physical and poor mental health days resulted in improved rank precision, as did the longitudinal model for age-specific mortality rates. Rank precision for low birth weight births and fair/poor health prevalence based on the univariate and joint outcome models were equivalent. Conclusion Incorporating longitudinal or pooled outcome data may improve rank certainty, depending on characteristics of the measures selected. For measures with different determinants, joint modeling neither improved nor degraded rank precision. This approach suggests a simple way to use existing information to improve the precision of small-area measures of population health. PMID:26098858

On Latent Growth Models for Composites and Their Constituents.

PubMed

Hancock, Gregory R; Mao, Xiulin; Kher, Hemant

2013-09-01

Over the last decade and a half, latent growth modeling has become an extremely popular and versatile technique for evaluating longitudinal change and its determinants. Most common among the models applied are those for a single measured variable over time. This model has been extended in a variety of ways, most relevant for the current work being the multidomain and the second-order latent growth models. Whereas the former allows for growth function characteristics to be modeled for multiple outcomes simultaneously, with the degree of growth characteristics' relations assessed within the model (e.g., cross-domain slope factor correlations), the latter models growth in latent outcomes, each of which has effect indicators repeated over time. But what if one has an outcome that is believed to be formative relative to its indicator variables rather than latent? In this case, where the outcome is a composite of multiple constituents, modeling change over time is less straightforward. This article provides analytical and applied details for simultaneously modeling growth in composites and their constituent elements, including a real data example using a general computer self-efficacy questionnaire.

MULTIVARIATE LINEAR MIXED MODELS FOR MULTIPLE OUTCOMES. (R824757)

EPA Science Inventory

We propose a multivariate linear mixed (MLMM) for the analysis of multiple outcomes, which generalizes the latent variable model of Sammel and Ryan. The proposed model assumes a flexible correlation structure among the multiple outcomes, and allows a global test of the impact of ...

A Genomic Score Prognostic of Outcome in Trauma Patients

PubMed Central

Warren, H Shaw; Elson, Constance M; Hayden, Douglas L; Schoenfeld, David A; Cobb, J Perren; Maier, Ronald V; Moldawer, Lyle L; Moore, Ernest E; Harbrecht, Brian G; Pelak, Kimberly; Cuschieri, Joseph; Herndon, David N; Jeschke, Marc G; Finnerty, Celeste C; Brownstein, Bernard H; Hennessy, Laura; Mason, Philip H; Tompkins, Ronald G

2009-01-01

Traumatic injuries frequently lead to infection, organ failure, and death. Health care providers rely on several injury scoring systems to quantify the extent of injury and to help predict clinical outcome. Physiological, anatomical, and clinical laboratory analytic scoring systems (Acute Physiology and Chronic Health Evaluation [APACHE], Injury Severity Score [ISS]) are utilized, with limited success, to predict outcome following injury. The recent development of techniques for measuring the expression level of all of a person’s genes simultaneously may make it possible to develop an injury scoring system based on the degree of gene activation. We hypothesized that a peripheral blood leukocyte gene expression score could predict outcome, including multiple organ failure, following severe blunt trauma. To test such a scoring system, we measured gene expression of peripheral blood leukocytes from patients within 12 h of traumatic injury. cRNA derived from whole blood leukocytes obtained within 12 h of injury provided gene expression data for the entire genome that were used to create a composite gene expression score for each patient. Total blood leukocytes were chosen because they are active during inflammation, which is reflective of poor outcome. The gene expression score combines the activation levels of all the genes into a single number which compares the patient’s gene expression to the average gene expression in uninjured volunteers. Expression profiles from healthy volunteers were averaged to create a reference gene expression profile which was used to compute a difference from reference (DFR) score for each patient. This score described the overall genomic response of patients within the first 12 h following severe blunt trauma. Regression models were used to compare the association of the DFR, APACHE, and ISS scores with outcome. We hypothesized that patients with a total gene response more different from uninjured volunteers would tend to have poorer outcome than those more similar. Our data show that for measures of poor outcome, such as infections, organ failures, and length of hospital stay, this is correct. DFR scores were associated significantly with adverse outcome, including multiple organ failure, duration of ventilation, length of hospital stay, and infection rate. The association remained significant after adjustment for injury severity as measured by APACHE or ISS. A single score representing changes in gene expression in peripheral blood leukocytes within hours of severe blunt injury is associated with adverse clinical outcomes that develop later in the hospital course. Assessment of genome-wide gene expression provides useful clinical information that is different from that provided by currently utilized anatomic or physiologic scores. PMID:19593405

Reducing, Maintaining, or Escalating Uncertainty? The Development and Validation of Four Uncertainty Preference Scales Related to Cancer Information Seeking and Avoidance.

PubMed

Carcioppolo, Nick; Yang, Fan; Yang, Qinghua

2016-09-01

Uncertainty is a central characteristic of many aspects of cancer prevention, screening, diagnosis, and treatment. Brashers's (2001) uncertainty management theory details the multifaceted nature of uncertainty and describes situations in which uncertainty can both positively and negatively affect health outcomes. The current study extends theory on uncertainty management by developing four scale measures of uncertainty preferences in the context of cancer. Two national surveys were conducted to validate the scales and assess convergent and concurrent validity. Results support the factor structure of each measure and provide general support across multiple validity assessments. These scales can advance research on uncertainty and cancer communication by providing researchers with measures that address multiple aspects of uncertainty management.

Impact of cataract surgery on vision-related life performances: the usefulness of Real-Life Vision Test for cataract surgery outcomes evaluation

PubMed Central

Ni, W; Li, X; Hou, Z; Zhang, H; Qiu, W; Wang, W

2015-01-01

Purpose Real-Life Vision Test (RLVT) is a newly developed performance-based measures of functional vision. This present study is designed to determine whether it could be a meaningful assessment for cataract surgery outcomes evaluation. Patients and methods Age-related cataract patients (56) who scheduled for bilateral cataract surgery and 44 age-matched controls were evaluated by four types of measurements: (1) demographic, medical, cognitive and depressive evaluation, and the reaction time testing; (2) clinical measures (visual acuity, contrast sensitivity, stereopsis, and color perception); (3) the 25-item National Eye Institute's Visual Functioning Questionnaire (NEI-VFQ); (4) the RLVT. Spearman's coefficients and multiple regression analysis were conducted to investigate the relationship among RLVT, clinical measures, and self-report assessment of visual function. Results The results of RLVT, clinical measures, and NEI-VFQ total scores were improved significantly after cataract surgery. There were no differences between control subjects and post-surgery patients with respect to NEI-VFQ-25 total scores, self-rating depression scale scores and three tasks of RLVT. Change of RLVT was significantly associated with the change of clinical measures in the cataract group. Multiple regression analysis demonstrated that change of distance, intermediate, and near visual acuity, and binocular contrast sensitivity were significant predictors of improvements of RLVT. Conclusions Cataract surgery could improve real-world visual ability effectively for cataract patients. Our study highlights the potential usefulness of RLVT as an adjunct to the current outcomes evaluation system for cataract surgery. The use of RLVT combined with clinical and self-survey methods may be the comprehensive strategy to manifest the impact of cataract surgery on patients' overall vision-related quality of life. PMID:26272444

AIS 2005: a contemporary injury scale.

PubMed

Gennarelli, Thomas A; Wodzin, Elaine

2006-12-01

To determine and to quantify outcome from injury demands that multiple factors be universally applied so that there is uniform understanding that the same outcome is understood for the same injury. It is thus important to define the variables used in any outcome assessment. Critical to defining outcomes is the need for a universal language that defines individual injuries. The abbreviated injury scale (AIS) is the only dictionary specifically designed as a system to define the severity of injuries throughout the body. In addition to a universal injury language, it provides measures of injury severity that can be used to stratify and classify injury severity in all body regions. Its revision, AIS 2005 will be discussed here.

Province-level income inequality and health outcomes in Canadian adolescents.

PubMed

Quon, Elizabeth C; McGrath, Jennifer J

2015-03-01

To examine the effects of provincial income inequality (disparity between rich and poor), independent of provincial income and family socioeconomic status, on multiple adolescent health outcomes. Participants (aged 12-17 years; N = 11,899) were from the Canadian National Longitudinal Survey of Children and Youth. Parental education, household income, province income inequality, and province mean income were measured. Health outcomes were measured across a number of domains, including self-rated health, mental health, health behaviors, substance use behaviors, and physical health. Income inequality was associated with injuries, general physical symptoms, and limiting conditions, but not associated with most adolescent health outcomes and behaviors. Income inequality had a moderating effect on family socioeconomic status for limiting conditions, hyperactivity/inattention, and conduct problems, but not for other outcomes. Province-level income inequality was associated with some physical and mental health outcomes in adolescents, which has research and policy implications for this age-group. © The Author 2014. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

What's Measured Is Not Necessarily What Matters: A Cautionary Story from Public Health

PubMed Central

Schwartz, Robert

2016-01-01

A systematic review of the introduction and use of outcome-based performance management systems for public health organizations found differences between their use as a management system (which requires rigorous definition and measurement to allow comparison across organizational units) versus for improvement (which may require more flexibility). What is included in performance measurement/management systems is influenced by ease of measurement, data quality, ability of organization to control outcomes, ability to measure success in terms of doing things (rather than preventing things) and what is already happening. To the extent that most providers wish to do a good job, the availability of good data to enable benchmarking and improvement is an important step forward. However, to the extent that the health of a population is dependent on multiple factors, many beyond the mandate of the health system, too extensive a reliance on performance measurement may risk unintended consequences of marginalizing critical activities. PMID:28032824

A Method of Calculating Functional Independence Measure at Discharge from Functional Independence Measure Effectiveness Predicted by Multiple Regression Analysis Has a High Degree of Predictive Accuracy.

PubMed

Tokunaga, Makoto; Watanabe, Susumu; Sonoda, Shigeru

2017-09-01

Multiple linear regression analysis is often used to predict the outcome of stroke rehabilitation. However, the predictive accuracy may not be satisfactory. The objective of this study was to elucidate the predictive accuracy of a method of calculating motor Functional Independence Measure (mFIM) at discharge from mFIM effectiveness predicted by multiple regression analysis. The subjects were 505 patients with stroke who were hospitalized in a convalescent rehabilitation hospital. The formula "mFIM at discharge = mFIM effectiveness × (91 points - mFIM at admission) + mFIM at admission" was used. By including the predicted mFIM effectiveness obtained through multiple regression analysis in this formula, we obtained the predicted mFIM at discharge (A). We also used multiple regression analysis to directly predict mFIM at discharge (B). The correlation between the predicted and the measured values of mFIM at discharge was compared between A and B. The correlation coefficients were .916 for A and .878 for B. Calculating mFIM at discharge from mFIM effectiveness predicted by multiple regression analysis had a higher degree of predictive accuracy of mFIM at discharge than that directly predicted. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Predicting well-being longitudinally for mothers rearing offspring with intellectual and developmental disabilities.

PubMed

Grein, K A; Glidden, L M

2015-07-01

Well-being outcomes for parents of children with intellectual and developmental disabilities (IDD) may vary from positive to negative at different times and for different measures of well-being. Predicting and explaining this variability has been a major focus of family research for reasons that have both theoretical and applied implications. The current study used data from a 23-year longitudinal investigation of adoptive and birth parents of children with IDD to determine which early child, mother and family characteristics would predict the variance in maternal outcomes 20 years after their original measurement. Using hierarchical regression analyses, we tested the predictive power of variables measured when children were 7 years old on outcomes of maternal well-being when children were 26 years old. Outcome variables included maternal self-report measures of depression and well-being. Final models of well-being accounted for 20% to 34% of variance. For most outcomes, Family Accord and/or the personality variable of Neuroticism (emotional stability/instability) were significant predictors, but some variables demonstrated a different pattern. These findings confirm that (1) characteristics of the child, mother and family during childhood can predict outcomes of maternal well-being 20 years later; and (2) different predictor-outcome relationships can vary substantially, highlighting the importance of using multiple measures to gain a more comprehensive understanding of maternal well-being. These results have implications for refining prognoses for parents and for tailoring service delivery to individual child, parent and family characteristics. © 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome

PubMed Central

Schoenfeld, David A.; Brown, Samuel M.; Hough, Catherine L.; Yealy, Donald M.; Moss, Marc; Angus, Derek C.; Iwashyna, Theodore J.

2017-01-01

Rationale: After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT’s power to measure significant differences in these outcomes is poorly understood. Objectives: Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes. Methods: We derived a general formula and Stata code for calculating an RCT’s power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress–like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT (www.clinicaltrials.gov identifier NCT02509078). Measurements and Main Results: On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity. Conclusions: Examining instruments’ power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities. PMID:27788018

Can job redesign interventions influence a broad range of employee outcomes by changing multiple job characteristics? A quasi-experimental study.

PubMed

Holman, David; Axtell, Carolyn

2016-07-01

Many job redesign interventions are based on a multiple mediator-multiple outcome model in which the job redesign intervention indirectly influences a broad range of employee outcomes by changing multiple job characteristics. As this model remains untested, the aim of this study is to test a multiple mediator-multiple outcome model of job redesign. Multilevel analysis of data from a quasi-experimental job redesign intervention in a call center confirmed the hypothesized model and showed that the job redesign intervention affected a broad range of employee outcomes (i.e., employee well-being, psychological contract fulfillment, and supervisor-rated job performance) through changes in 2 job characteristics (i.e., job control and feedback). The results provide further evidence for the efficacy and mechanisms of job redesign interventions. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Impact of Collegiate Recreation on Academic Success

ERIC Educational Resources Information Center

Sanderson, Heather; DeRousie, Jason; Guistwite, Nicole

2018-01-01

This study examined the impact of collegiate recreation participation on academic success as measured by grade point average, course credit completion, and persistence or graduation. Logistic and multiple regressions were run to explore the relationship between total recreation contact hours and outcome variables. Results indicated a positive and…

Comparing Dynamic Treatment Regimes Using Repeated-Measures Outcomes: Modeling Considerations in SMART Studies

PubMed Central

Lu, Xi; Nahum-Shani, Inbal; Kasari, Connie; Lynch, Kevin G.; Oslin, David W.; Pelham, William E.; Fabiano, Gregory; Almirall, Daniel

2016-01-01

A dynamic treatment regime (DTR) is a sequence of decision rules, each of which recommends a treatment based on a patient’s past and current health status. Sequential, multiple assignment, randomized trials (SMARTs) are multi-stage trial designs that yield data specifically for building effective DTRs. Modeling the marginal mean trajectories of a repeated-measures outcome arising from a SMART presents challenges, because traditional longitudinal models used for randomized clinical trials do not take into account the unique design features of SMART. We discuss modeling considerations for various forms of SMART designs, emphasizing the importance of considering the timing of repeated measures in relation to the treatment stages in a SMART. For illustration, we use data from three SMART case studies with increasing level of complexity, in autism, child attention deficit hyperactivity disorder (ADHD), and adult alcoholism. In all three SMARTs we illustrate how to accommodate the design features along with the timing of the repeated measures when comparing DTRs based on mean trajectories of the repeated-measures outcome. PMID:26638988

New agreement measures based on survival processes

PubMed Central

Guo, Ying; Li, Ruosha; Peng, Limin; Manatunga, Amita K.

2013-01-01

Summary The need to assess agreement arises in many scenarios in biomedical sciences when measurements were taken by different methods on the same subjects. When the endpoints are survival outcomes, the study of agreement becomes more challenging given the special characteristics of time-to-event data. In this paper, we propose a new framework for assessing agreement based on survival processes that can be viewed as a natural representation of time-to-event outcomes. Our new agreement measure is formulated as the chance-corrected concordance between survival processes. It provides a new perspective for studying the relationship between correlated survival outcomes and offers an appealing interpretation as the agreement between survival times on the absolute distance scale. We provide a multivariate extension of the proposed agreement measure for multiple methods. Furthermore, the new framework enables a natural extension to evaluate time-dependent agreement structure. We develop nonparametric estimation of the proposed new agreement measures. Our estimators are shown to be strongly consistent and asymptotically normal. We evaluate the performance of the proposed estimators through simulation studies and then illustrate the methods using a prostate cancer data example. PMID:23844617

Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies.

PubMed

Lu, Xi; Nahum-Shani, Inbal; Kasari, Connie; Lynch, Kevin G; Oslin, David W; Pelham, William E; Fabiano, Gregory; Almirall, Daniel

2016-05-10

A dynamic treatment regime (DTR) is a sequence of decision rules, each of which recommends a treatment based on a patient's past and current health status. Sequential, multiple assignment, randomized trials (SMARTs) are multi-stage trial designs that yield data specifically for building effective DTRs. Modeling the marginal mean trajectories of a repeated-measures outcome arising from a SMART presents challenges, because traditional longitudinal models used for randomized clinical trials do not take into account the unique design features of SMART. We discuss modeling considerations for various forms of SMART designs, emphasizing the importance of considering the timing of repeated measures in relation to the treatment stages in a SMART. For illustration, we use data from three SMART case studies with increasing level of complexity, in autism, child attention deficit hyperactivity disorder, and adult alcoholism. In all three SMARTs, we illustrate how to accommodate the design features along with the timing of the repeated measures when comparing DTRs based on mean trajectories of the repeated-measures outcome. Copyright © 2015 John Wiley & Sons, Ltd.

The effects of a multiple family therapy on adolescents with eating disorders: an outcome study.

PubMed

Gelin, Zoé; Fuso, Silvana; Hendrick, Stephan; Cook-Darzens, Solange; Simon, Yves

2015-03-01

Multiple Family Therapy (MFT) has gained increasing popularity in the treatment of eating disorders and many programs have been developed over the past decade. Still, there is little evidence in the literature on the effectiveness on MFT for treating eating disorders. The present study examines the effects of a particular model of Multiple Family Therapy on eating disorder symptoms, quality of life, and percentage of Expected Body Weight (%EBW) in adolescents with eating disorders (ED). Eighty-two adolescents with ED, aged between 11 and 19 years, were assessed before and after treatment using the Eating Disorders Inventory 2 (EDI-2), the Outcome Questionnaire 45 (OQ-45) and %EBW. Results showed a significant increase in %EBW between the beginning and end of treatment, with a large effect size. 52.4% of patients achieved an EBW above 85%. Symptoms relative to all EDI dimensions (except for bulimia) significantly decreased during treatment. The three dimensions related to quality of life assessment also improved over the course of MFT. At the end of treatment, 70.7% of patients had a total OQ-45 score below clinical significance. This study suggests that Multiple Family Therapy may benefit adolescents with eating disorders, with improvement on several outcome measures (%EBW, ED symptoms, and quality of life). However, the lack of a comparison group entails caution when drawing conclusions. © 2014 Family Process Institute.

Factors associated with unhealthy behaviours and health outcomes: a cross-sectional study among Tuscan adolescents (Italy).

PubMed

Lazzeri, Giacomo; Azzolini, Elena; Pammolli, Andrea; Simi, Rita; Meoni, Veronica; Giacchi, Mariano Vincenzo

2014-09-25

We aimed to determine the extent to which three core variables (school environment, peer group and family affluence) were associated with unhealthy behaviours and health outcomes among Tuscan adolescents. The unhealthy behaviours considered were smoking, alcohol consumption, sedentary lifestyle and irregular breakfast consumption; health outcomes were classified as self-reported health, multiple health complaints and life satisfaction. School environment was measured in terms of liking school, school pressure, academic achievement and classmate support; peer groups were evaluated in terms of the number of peers and frequency of peer contact. Family affluence was measured on a socioeconomic scale. Data were taken from the Tuscan 2009/10 survey of "Health Behaviour in School-aged Children", a WHO cross-national survey. A binary logistic multiple regression (95% confidence intervals) was implemented. The total sample comprised 3291 school students: 1135 11-year-olds, 1255 13-year-olds and 901 15-year-olds. Peer group and school environment were associated with unhealthy behaviours such as smoking, alcohol consumption and sedentary lifestyle. Family affluence proved to have less impact on unhealthy behaviours, except in the case of adolescents living in low-income families. Poor health outcomes were directly related to a negative school environment. Regarding the influence of family affluence, the results showed higher odds of life dissatisfaction and poor self-reported health status in medium-income families, while low-income families had higher odds only with regard to life dissatisfaction. A consistent pattern of gender differences was found in terms of both unhealthy behaviours and health outcomes. Unhealthy behaviours are strongly related to the school environment and peer group. A negative school environment proved to have the strongest relation with poor health outcomes.

Effects of lifestyle change interventions for people with intellectual disabilities: Systematic review and meta-analysis of randomized controlled trials.

PubMed

Willems, Mariël; Waninge, Aly; Hilgenkamp, Thessa I M; van Empelen, Pepijn; Krijnen, Wim P; van der Schans, Cees P; Melville, Craig A

2018-05-08

Promotion of a healthy lifestyle for people with intellectual disabilities is important; however, the effectiveness of lifestyle change interventions is unclear. This research will examine the effectiveness of lifestyle change interventions for people with intellectual disabilities. Randomized controlled trials (RCTs) of lifestyle change interventions for people with intellectual disabilities were included in a systematic review and meta-analysis. Data on study and intervention characteristics were extracted, as well as data on outcome measures and results. Internal validity of the selected papers was assessed using the Cochrane Collaboration's risk bias tool. Eight RCTs were included. Multiple outcome measures were used, whereby outcome measures targeting environmental factors and participation were lacking and personal outcome measures were mostly used by a single study. Risks of bias were found for all studies. Meta-analysis showed some effectiveness for lifestyle change interventions, and a statistically significant decrease was found for waist circumference. Some effectiveness was found for lifestyle change interventions for people with intellectual disabilities. However, the effects were only statistically significant for waist circumference, so current lifestyle change interventions may not be optimally tailored to meet the needs of people with intellectual disabilities. © 2018 John Wiley & Sons Ltd.

Writing Multiple Choice Outcome Questions to Assess Knowledge and Competence.

PubMed

Brady, Erik D

2015-11-01

Few articles contemplate the need for good guidance in question item-writing in the continuing education (CE) space. Although many of the core principles of sound item design translate to the CE health education team, the need exists for specific examples for nurse educators that clearly describe how to measure changes in competence and knowledge using multiple choice items. In this article, some keys points and specific examples for nursing CE providers are shared. Copyright 2015, SLACK Incorporated.

Modeling and Predicting Hearing Aid Outcome

PubMed Central

Humes, Larry E.

2003-01-01

Following a brief tutorial on the application of factor analysis to hearing aid outcome measures, three studies of hearing aid outcome measures in elderly adults are presented and analyzed. Two of the studies were completed at Indiana University (IU-1 and IU-2), and one was a collaborative multisite study by the Veterans Administration and the National Institute of Deafness and other Communication Disorders (NIDCD/VA). IU-1 measured hearing aid outcome in 173 elderly wearers of single-channel, linear, in-the-ear hearing aids with output-limiting compression, whereas IU-2 obtained the same extensive set of outcome measures from 53 elderly wearers of two-channel, wide-dynamic-range compression, in-the-canal hearing aids. In the NIDCD/VA study, 333 to 338 participants wore three single-channel circuits in succession, with each circuit housed within an in-the-ear shell. The three circuits included in that study and in this analysis were: (1) linear with peak clipping, (2) linear with output-limiting compression, and (3) single-channel, wide-dynamic-range compression. Evaluation of the many outcome measures completed in each study using principal components factor analysis revealed that from three (both IU studies) to five (NIDCD/VA study) principal components captured the individual differences in hearing aid outcome. This was independent of hearing aid type (in-the-ear or in-the-canal) and circuitry. Subsequent multiple regression analyses of individual differences in performance along each dimension of hearing aid outcome revealed that these individual differences could be accounted for reasonably well by various prefit variables for some dimensions of outcome, but not others. In general, measures of speech recognition performance were well accounted for by prefit measures, with the best predictors being hearing loss, cognitive performance, and age. Measures of hearing aid usage were less well accounted for by prefit measures, with the most accurate predictor of current hearing aid use being prior hearing aid use. The outcome dimension accounted for most poorly was that associated with hearing aid satisfaction, with subjective measures of aided sound quality being the best predictor of performance along this dimension of hearing aid outcome. Additional multicenter, large-scale studies are needed to develop more complete models of hearing aid outcome and to identify the variables that influence various aspects of hearing aid outcome. It is only through this additional research that it will be possible to optimize outcome for hearing aid wearers. PMID:15004647

Commentary: measuring quality of care in osteoporosis.

PubMed

Silverman, Stuart L; Curtis, Jeffrey

2013-12-01

We know improving the quality of care in osteoporosis is an important goal. We have made some strides toward measuring quality of osteoporosis care, focusing on process measures regarding care that is provided. Unfortunately, improving care as measured by these process measures does not always yield improved outcomes. We need to hold health care providers and health care systems responsible not only for health care production but for production of health and well-being. However, there is a multiplicity of factors that will need to be considered to make this next step.

Inequalities in multiple health outcomes by education, sex, and race in 93 US counties: why we should measure them all.

PubMed

Asada, Yukiko; Whipp, Alyce; Kindig, David; Billard, Beverly; Rudolph, Barbara

2014-06-13

Regular reporting of health inequalities is essential to monitoring progress of efforts to reduce health inequalities. While reporting of population health became increasingly common, reporting of a subpopulation group breakdown of each indicator of the health of the population is rarely a standard practice. This study reports education-, sex-, and race-related inequalities in four health outcomes in each of the selected 93 counties in the United States in a systematic and comparable manner. This study is a cross-sectional analysis of large, publicly available data, 2008, 2009, and 2010 Behavioral Risk Factor Surveillance System (BRFSS) Selected Metropolitan/Micropolitan Area Risk Trends (SMART) and 2008, 2009, and 2010 United States Birth Records from the National Vital Statistics System. The study population is American adults older than 25 years of age residing in the selected 93 counties, representing about 30% of the US population, roughly equally covering all geographic regions of the country. Main outcome measures are: (1) Attribute (group characteristic)-specific inequality: education-, sex-, or race-specific inequality in each of the four health outcomes (poor or fair health, poor physical health days, poor mental health days, and low birthweight) in each county; (2) Overall inequality: the average of these three attribute-specific inequalities for each health outcome in each county; and (3) Summary inequality in total morbidity: the weighted average of the overall inequalities across the four health outcomes in each county. The range of inequality across the counties differed considerably by health outcome; inequality in poor or fair health had the widest range and the highest median among inequalities in all health outcomes. In more than 70% of the counties, education-specific inequality was the largest in all health outcomes except for low birthweight. It is feasible to extend population health reporting to include reporting of a subpopulation group breakdown of each indicator of the health of the population at a small jurisdictional level using publicly available data. No single group characteristic or health outcome represents the whole picture of health inequalities in a population. Examining multiple group characteristics and outcomes in a comparable manner is essential in reporting health inequalities.

Temporal Stability of Multiple Response Systems to 7.5% Carbon Dioxide Challenge

PubMed Central

Roberson-Nay, Roxann; Gorlin, Eugenia I.; Beadel, Jessica R.; Cash, Therese; Vrana, Scott; Teachman, Bethany A.

2017-01-01

Self-reported anxiety, and potentially physiological response, to maintained inhalation of carbon dioxide (CO2) enriched air shows promise as a putative marker of panic reactivity and vulnerability. Temporal stability of response systems during low-dose, steady-state CO2 breathing challenge is lacking. Outcomes on multiple levels were measured two times, one week apart, in 93 individuals. Stability was highest during the CO2 breathing phase compared to pre-CO2 and recovery phases, with anxiety ratings, respiratory rate, skin conductance level, and heart rate demonstrating good to excellent temporal stability (ICCs ≥ 0.71). Cognitive symptoms tied to panic were somewhat less stable (ICC = 0.58) than physical symptoms (ICC = 0.74) during CO2 breathing. Escape/avoidance behaviors and DSM-5 panic attacks were not stable. Large effect sizes between task phases also were observed. Overall, results suggest good-excellent levels of temporal stability for multiple outcomes during respiratory stimulation via 7.5% CO2. PMID:28163046

Statistical Power in Evaluations That Investigate Effects on Multiple Outcomes: A Guide for Researchers

ERIC Educational Resources Information Center

Porter, Kristin E.

2016-01-01

In education research and in many other fields, researchers are often interested in testing the effectiveness of an intervention on multiple outcomes, for multiple subgroups, at multiple points in time, or across multiple treatment groups. The resulting multiplicity of statistical hypothesis tests can lead to spurious findings of effects. Multiple…

A Participatory Action Research Approach To Evaluating Inclusive School Programs.

ERIC Educational Resources Information Center

Dymond, Stacy K.

2001-01-01

This article proposes a model for evaluating inclusive schools. Key elements of the model are inclusion of stakeholders in the evaluation process through a participatory action research approach, analysis of program processes and outcomes, use of multiple methods and measures, and obtaining perceptions from diverse stakeholder groups. (Contains…

The Vale rangeland rehabilitation program: an evaluation.

Treesearch

Harold F. Heady

1988-01-01

This manuscript discusses the initiation, execution, and outcome of an 11-year (1962-1972) rangeland rehabilitation program in southeastern Oregon. Res. Bull. PNW-RB-070 (1977) is updated with 1986 measurements and evaluations of vegetational conditions, wildlife, recreational use, livestock grazing, and management of public rangelands. The mix of multiple uses has...

Optimizing Educational Video through Comparative Trials in Clinical Environments

ERIC Educational Resources Information Center

Aronson, Ian David; Plass, Jan L.; Bania, Theodore C.

2012-01-01

Although video is increasingly used in public health education, studies generally do not implement randomized trials of multiple video segments in clinical environments. Therefore, the specific configurations of educational videos that will have the greatest impact on outcome measures ranging from increased knowledge of important public health…

Factors Influencing the Academic Achievement of First-Generation College Students

ERIC Educational Resources Information Center

Strayhorn, Terrell L.

2006-01-01

First-generation college students face a number of unique challenges in college. These obstacles may have a disparate effect on educational outcomes such as academic achievement. This study presents findings from an analysis of the Baccalaureate & Beyond Longitudinal Study using hierarchical multiple regression techniques to measure the influence…

Relaxation Training: Its Usefulness in the Middle School Curriculum.

ERIC Educational Resources Information Center

Matthews, Doris B.

A study examined multiple outcomes of relaxation training simultaneously in seventh grade classrooms. "Project Relaxation" measured cognitive (achievement) and affective (discipline, attendance, tardiness, and self-concept) changes with a program of relaxation training for 532 seventh grade students in 10 private and public middle schools in South…

Integrated Approach to Reduce Perinatal Adverse Events: Standardized Processes, Interdisciplinary Teamwork Training, and Performance Feedback.

PubMed

Riley, William; Begun, James W; Meredith, Les; Miller, Kristi K; Connolly, Kathy; Price, Rebecca; Muri, Janet H; McCullough, Mac; Davis, Stanley

2016-12-01

To improve safety practices and reduce adverse events in perinatal units of acute care hospitals. Primary data collected from perinatal units of 14 hospitals participating in the intervention between 2008 and 2012. Baseline secondary data collected from the same hospitals between 2006 and 2007. A prospective study involving 342,754 deliveries was conducted using a quality improvement collaborative that supported three primary interventions. Primary measures include adoption of three standardized care processes and four measures of outcomes. Chart audits were conducted to measure the implementation of standardized care processes. Outcome measures were collected and validated by the National Perinatal Information Center. The hospital perinatal units increased use of all three care processes, raising consolidated overall use from 38 to 81 percent between 2008 and 2012. The harms measured by the Adverse Outcome Index decreased 14 percent, and a run chart analysis revealed two special causes associated with the interventions. This study demonstrates the ability of hospital perinatal staff to implement efforts to reduce perinatal harm using a quality improvement collaborative. Findings help inform the relationship between the use of standardized care processes, teamwork training, and improved perinatal outcomes, and suggest that a multiplicity of integrated strategies, rather than a single intervention, may be essential to achieve high reliability. © Health Research and Educational Trust.

Assessment of a new web-based sexual concurrency measurement tool for men who have sex with men.

PubMed

Rosenberg, Eli S; Rothenberg, Richard B; Kleinbaum, David G; Stephenson, Rob B; Sullivan, Patrick S

2014-11-10

Men who have sex with men (MSM) are the most affected risk group in the United States' human immunodeficiency virus (HIV) epidemic. Sexual concurrency, the overlapping of partnerships in time, accelerates HIV transmission in populations and has been documented at high levels among MSM. However, concurrency is challenging to measure empirically and variations in assessment techniques used (primarily the date overlap and direct question approaches) and the outcomes derived from them have led to heterogeneity and questionable validity of estimates among MSM and other populations. The aim was to evaluate a novel Web-based and interactive partnership-timing module designed for measuring concurrency among MSM, and to compare outcomes measured by the partnership-timing module to those of typical approaches in an online study of MSM. In an online study of MSM aged ≥18 years, we assessed concurrency by using the direct question method and by gathering the dates of first and last sex, with enhanced programming logic, for each reported partner in the previous 6 months. From these methods, we computed multiple concurrency cumulative prevalence outcomes: direct question, day resolution / date overlap, and month resolution / date overlap including both 1-month ties and excluding ties. We additionally computed variants of the UNAIDS point prevalence outcome. The partnership-timing module was also administered. It uses an interactive month resolution calendar to improve recall and follow-up questions to resolve temporal ambiguities, combines elements of the direct question and date overlap approaches. The agreement between the partnership-timing module and other concurrency outcomes was assessed with percent agreement, kappa statistic (κ), and matched odds ratios at the individual, dyad, and triad levels of analysis. Among 2737 MSM who completed the partnership section of the partnership-timing module, 41.07% (1124/2737) of individuals had concurrent partners in the previous 6 months. The partnership-timing module had the highest degree of agreement with the direct question. Agreement was lower with date overlap outcomes (agreement range 79%-81%, κ range .55-.59) and lowest with the UNAIDS outcome at 5 months before interview (65% agreement, κ=.14, 95% CI .12-.16). All agreements declined after excluding individuals with 1 sex partner (always classified as not engaging in concurrency), although the highest agreement was still observed with the direct question technique (81% agreement, κ=.59, 95% CI .55-.63). Similar patterns in agreement were observed with dyad- and triad-level outcomes. The partnership-timing module showed strong concurrency detection ability and agreement with previous measures. These levels of agreement were greater than others have reported among previous measures. The partnership-timing module may be well suited to quantifying concurrency among MSM at multiple levels of analysis.

Validating Measures of Real-World Outcome: The Results of the VALERO Expert Survey and RAND Panel

PubMed Central

Leifker, Feea R.; Patterson, Thomas L.; Heaton, Robert K.; Harvey, Philip D.

2011-01-01

Background: People with schizophrenia demonstrate considerable discrepancy between self-reported functioning and informant reports. It is not clear whether these discrepancies originate from the instruments used or from the perspectives of different informants. The goal of the Validation of Everyday Real-World Outcomes (VALERO) Study is to enhance the measurement of real-world (RW) outcomes in the social, residential, and vocational domains through selection of optimal scales and informants using a multistep process similar to the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative. Methods: Forty-eight experts provided their opinion regarding the best scales measuring RW outcomes. Fifty-nine measures were nominated. The investigators selected the 11 scales that were the most highly nominated, had the most published validity data, and best represented the domains of interest. Information was provided to other experts who served as RAND panelists. Panelists rated each measure for its suitability across multiple a priori domains. Discrepant ratings were discussed until consensus was reached. Results: Following the RAND Panel, the 2 scales that scored highest across the various criteria for each of the classes of scales (hybrid, social functioning, and everyday living skills) were selected for use in the first substudy of VALERO. The scales selected were the Quality-of-Life Scale, Specific Levels of Functioning Scale, Social Behavior Schedule, Social Functioning Scale, Independent Living Skills Schedule, and Life Skills Profile. Discussion: The results show that although there are significant limitations with current scales used for the assessment of RW outcome in schizophrenia, a consensus is possible. Further, several existing instruments were rated as useful for measuring social, residential, and vocational outcomes. PMID:19525354

Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome.

PubMed

Sjoding, Michael W; Schoenfeld, David A; Brown, Samuel M; Hough, Catherine L; Yealy, Donald M; Moss, Marc; Angus, Derek C; Iwashyna, Theodore J

2017-01-01

After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT's power to measure significant differences in these outcomes is poorly understood. Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes. We derived a general formula and Stata code for calculating an RCT's power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress-like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT ( www.clinicaltrials.gov identifier NCT02509078). On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity. Examining instruments' power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities.

Comparing contents of outcome measures in cerebral palsy using the International Classification of Functioning (ICF-CY): a systematic review.

PubMed

Schiariti, Veronica; Klassen, Anne F; Cieza, Alarcos; Sauve, Karen; O'Donnell, Maureen; Armstrong, Robert; Mâsse, Louise C

2014-01-01

The International Classification of Functioning children and youth version (ICF-CY) provides a universal framework for defining and classifying functioning and disability in children worldwide. To facilitate the application of the ICF in practice, ICF based-tools like the "ICF Core Sets" are being developed. In the context of the development of the ICF-CY Core Sets for children with Cerebral Palsy (CP), the aims of this study were as follows: to identify and compare the content of outcome measures used in studies of children with CP using the ICF-CY coding system; and to describe the most frequently addressed areas of functioning in those studies. We searched multiple databases likely to capture studies involving children with CP from January 1998 to March 2012. We included all English language articles that studied children aged 2-18 years and described an interventional or observational study. Constructs of the outcome measures identified in studies were linked to the ICF-CY by two trained professionals. We found 231 articles that described 238 outcome measures. The outcome measures contained 2193 concepts that were linked to the ICF-CY and covered 161 independent ICF-CY categories. Out of the 161 categories, 53 (33.5%) were related to body functions, 75 (46%) were related to activities/participation, 26 (16.1%) were related to environmental factors, and 7 (4.3%) were related to body structures. This systematic review provides information about content of measures that may guide researchers and clinicians in their selection of an outcome measure for use in a study and/or clinical practice with children with CP. Copyright © 2013 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

What is the best ST-segment recovery parameter to predict clinical outcome and myocardial infarct size? Amplitude, speed, and completeness of ST-segment recovery after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

PubMed

Kuijt, Wichert J; Green, Cindy L; Verouden, Niels J W; Haeck, Joost D E; Tzivoni, Dan; Koch, Karel T; Stone, Gregg W; Lansky, Alexandra J; Broderick, Samuel; Tijssen, Jan G P; de Winter, Robbert J; Roe, Matthew T; Krucoff, Mitchell W

ST-segment recovery (STR) is a strong mechanistic correlate of infarct size (IS) and outcome in ST-segment elevation myocardial infarction (STEMI). Characterizing measures of speed, amplitude, and completeness of STR may extend the use of this noninvasive biomarker. Core laboratory continuous 24-h 12-lead Holter ECG monitoring, IS by single-photon emission computed tomography (SPECT), and 30-day mortality of 2 clinical trials of primary percutaneous coronary intervention in STEMI were combined. Multiple ST measures (STR at last contrast injection (LC) measured from peak value; 30, 60, 90, 120, and 240min, residual deviation; time to steady ST recovery; and the 3-h area under the time trend curve [ST-AUC] from LC) were univariably correlated with IS and predictive of mortality. After multivariable adjustment for ST-parameters and GRACE risk factors, STR at 240min remained an additive predictor of mortality. Early STR, residual deviation, and ST-AUC remained associated with IS. Multiple parameters that quantify the speed, amplitude, and completeness of STR predict mortality and correlate with IS. Copyright © 2017. Published by Elsevier Inc.

Rapid Response Teams: Is it Time to Reframe the Questions of Rapid Response Team Measurement?

PubMed

Salvatierra, Gail G; Bindler, Ruth C; Daratha, Kenn B

2016-11-01

The purpose of this article is to present an overview of rapid response team (RRT) history in the United States, provide a review of prior RRT effectiveness research, and propose the reframing of four new questions of RRT measurement that are designed to better understand RRTs in the context of contemporary nursing practice as well as patient outcomes. RRTs were adopted in the United States because of their intuitive appeal, and despite a lack of evidence for their effectiveness. Subsequent studies used mortality and cardiac arrest rates to measure whether or not RRTs "work." Few studies have thoroughly examined the effect of RRTs on nurses and on nursing practice. An extensive literature review provided the background. Suppositions and four critical, unanswered questions arising from the literature are suggested. The results of RRT effectiveness, which have focused on patient-oriented outcomes, have been ambiguous, contradictory, and difficult to interpret. Additionally, they have not taken into account the multiple ways in which these teams have impacted nurses and nursing practice as well as patient outcomes. What happens in terms of RRT process and utilization is likely to have a major impact on nurses and nursing care on general medical and surgical wards. What that impact will be depends on what we can learn from measuring with an expanded yardstick, in order to answer the question, "Do RRTs work?" Evidence for the benefits of RRTs depends on proper framing of questions relating to their effectiveness, including the multiple ways RRTs contribute to nursing efficacy. © 2016 Sigma Theta Tau International.

Analysis of longitudinal multivariate outcome data from couples cohort studies: application to HPV transmission dynamics

PubMed Central

Kong, Xiangrong; Wang, Mei-Cheng; Gray, Ronald

2014-01-01

We consider a specific situation of correlated data where multiple outcomes are repeatedly measured on each member of a couple. Such multivariate longitudinal data from couples may exhibit multi-faceted correlations which can be further complicated if there are polygamous partnerships. An example is data from cohort studies on human papillomavirus (HPV) transmission dynamics in heterosexual couples. HPV is a common sexually transmitted disease with 14 known oncogenic types causing anogenital cancers. The binary outcomes on the multiple types measured in couples over time may introduce inter-type, intra-couple, and temporal correlations. Simple analysis using generalized estimating equations or random effects models lacks interpretability and cannot fully utilize the available information. We developed a hybrid modeling strategy using Markov transition models together with pairwise composite likelihood for analyzing such data. The method can be used to identify risk factors associated with HPV transmission and persistence, estimate difference in risks between male-to-female and female-to-male HPV transmission, compare type-specific transmission risks within couples, and characterize the inter-type and intra-couple associations. Applying the method to HPV couple data collected in a Ugandan male circumcision (MC) trial, we assessed the effect of MC and the role of gender on risks of HPV transmission and persistence. PMID:26195849

[Modified McPeek score in multiple trauma patients. Prospective evaluation of a points system for recording follow-up factors].

PubMed

Mathis, S; Kellermann, S; Schmid, S; Mutschlechner, H; Raab, H; Wenzel, V; El Attal, R; Kreutziger, J

2014-05-01

Many commonly available trauma scores predict mortality, but to evaluate the success of a certain therapy or for difficult scientific and epidemiological purposes this may be insufficient in the face of improved survival rates. For outcome analysis of multiple trauma patients, the extent of medical resources needed could be an additional outcome measurement. McPeek et al. developed a potential scoring system for elective surgery patients, which was recently modified for multiple trauma patients. The current study investigated if the McPeek score could be prospectively used in multiple trauma patients and whether it could become an additional helpful tool in outcome assessment. Applicability was assessed by practical examples. In this prospective single-centre study at the University Hospital of Innsbruck, Austria, between December 2008 and November 2010 multiple trauma patients (≥ 18 years) with an injury severity score (ISS) ≥ 17 were enrolled. Besides demographic data, prehospital vital parameters and diagnoses, all diagnoses from the trauma, mortality, length of stay in the intensive care unit and the hospital were recorded. The commonly used trauma scores ISS, revised trauma score (RTS), a severity characterization of trauma (ASCOT) and trauma and injury severity score (TRISS) were applied and an observed McPeek score was allocated following end of hospitalization. The McPeek scoring system was used according to the latest modifications. A correlation between trauma scores and the McPeek score was performed. The McPeek score was then predicted by a common trauma score using ordinal regression with the polytomous universal model (PLUM method). By subtracting the predicted from the observed McPeek scores the residual McPeek value was calculated and used for practical examples of outcome analysis with the McPeek scoring system. Out of 406 identified multiple trauma patients during the study phase, 183 had to be excluded due to missing data (mainly prehospital or following transfer). A total of 223 patients (mean ISS 31.2, mean age 47.2 years) were enrolled and assigned to the population-based observed McPeek score (median 4.0). Correlation coefficients were Glasgow coma scale (GCS) 0.59, ISS 0.62, RTS 0.65, TRISS 0.74 and ASCOT 0.77 (p < 0.0001). The TRISS predicted the McPeek score best in ordinal regression (pseudo-R(2) = 0.944, p < 0.0001). The residual McPeek score (observed minus predicted) was used to illustrate the influence of the blood glucose level on admission and the influence of head injury on outcome of multiple injury patients in detail. The modified McPeek score is applicable to multiple trauma patients to assess outcome for scientific or epidemiological purposes. Its main advantage is that it quantifies outcome independently of regional or national circumstances.

Measuring ability to assess claims about treatment effects: a latent trait analysis of items from the 'Claim Evaluation Tools' database using Rasch modelling.

PubMed

Austvoll-Dahlgren, Astrid; Guttersrud, Øystein; Nsangi, Allen; Semakula, Daniel; Oxman, Andrew D

2017-05-25

The Claim Evaluation Tools database contains multiple-choice items for measuring people's ability to apply the key concepts they need to know to be able to assess treatment claims. We assessed items from the database using Rasch analysis to develop an outcome measure to be used in two randomised trials in Uganda. Rasch analysis is a form of psychometric testing relying on Item Response Theory. It is a dynamic way of developing outcome measures that are valid and reliable. To assess the validity, reliability and responsiveness of 88 items addressing 22 key concepts using Rasch analysis. We administrated four sets of multiple-choice items in English to 1114 people in Uganda and Norway, of which 685 were children and 429 were adults (including 171 health professionals). We scored all items dichotomously. We explored summary and individual fit statistics using the RUMM2030 analysis package. We used SPSS to perform distractor analysis. Most items conformed well to the Rasch model, but some items needed revision. Overall, the four item sets had satisfactory reliability. We did not identify significant response dependence between any pairs of items and, overall, the magnitude of multidimensionality in the data was acceptable. The items had a high level of difficulty. Most of the items conformed well to the Rasch model's expectations. Following revision of some items, we concluded that most of the items were suitable for use in an outcome measure for evaluating the ability of children or adults to assess treatment claims. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cross-Language Measurement Equivalence of the Center for Epidemiologic Studies Depression (CES-D) Scale in Systemic Sclerosis: A Comparison of Canadian and Dutch Patients

PubMed Central

Kwakkenbos, Linda; Arthurs, Erin; van den Hoogen, Frank H. J.; Hudson, Marie; van Lankveld, Wim G. J. M.; Baron, Murray; van den Ende, Cornelia H. M.; Thombs, Brett D.

2013-01-01

Objectives Increasingly, medical research involves patients who complete outcomes in different languages. This occurs in countries with more than one common language, such as Canada (French/English) or the United States (Spanish/English), as well as in international multi-centre collaborations, which are utilized frequently in rare diseases such as systemic sclerosis (SSc). In order to pool or compare outcomes, instruments should be measurement equivalent (invariant) across cultural or linguistic groups. This study provides an example of how to assess cross-language measurement equivalence by comparing the Center for Epidemiologic Studies Depression (CES-D) scale between English-speaking Canadian and Dutch SSc patients. Methods The CES-D was completed by 922 English-speaking Canadian and 213 Dutch SSc patients. Confirmatory factor analysis (CFA) was used to assess the factor structure in both samples. The Multiple-Indicator Multiple-Cause (MIMIC) model was utilized to assess the amount of differential item functioning (DIF). Results A two-factor model (positive and negative affect) showed excellent fit in both samples. Statistically significant, but small-magnitude, DIF was found for 3 of 20 items on the CES-D. The English-speaking Canadian sample endorsed more feeling-related symptoms, whereas the Dutch sample endorsed more somatic/retarded activity symptoms. The overall estimate in depression scores between English and Dutch was not influenced substantively by DIF. Conclusions CES-D scores from English-speaking Canadian and Dutch SSc patients can be compared and pooled without concern that measurement differences may substantively influence results. The importance of assessing cross-language measurement equivalence in rheumatology studies prior to pooling outcomes obtained in different languages should be emphasized. PMID:23326538

Perinatal outcomes for Asian, Native Hawaiian, and other Pacific Islander mothers of single and multiple race/ethnicity: California and Hawaii, 2003-2005.

PubMed

Schempf, Ashley H; Mendola, Pauline; Hamilton, Brady E; Hayes, Donald K; Makuc, Diane M

2010-05-01

We examined characteristics and birth outcomes of Asian/Pacific Islander (API) mothers to determine whether differences in outcomes existed between mothers of single race/ethnicity and multiple race/ethnicity. We used data from California and Hawaii birth certificates from 2003 through 2005 to describe variation in birth outcomes for API subgroups by self-reported maternal race/ethnicity (single versus multiple race or API subgroup), and we also compared these outcomes to those of non-Hispanic White women. Low birthweight (LBW) and preterm birth (PTB) varied more among API subgroups than between mothers of single versus multiple race/ethnicity. After adjustment for sociodemographic and behavioral risk factors, API mothers of multiple race/ethnicity had outcomes similar to mothers of single race/ethnicity, with exceptions for multiple-race/ethnicity Chinese (higher PTB), Filipino (lower LBW and PTB), and Thai (higher LBW) subgroups. Compared with single-race non-Hispanic Whites, adverse outcomes were elevated for most API subgroups: only single-race/ethnicity Korean mothers had lower rates of both LBW (3.4%) and PTB (5.6%); single-race/ethnicity Cambodian, Laotian, and Marshallese mothers had the highest rates of both LBW (8.8%, 9.2%, and 8.4%, respectively) and PTB (14.0%, 13.7%, and 18.8%, respectively). Strategies to improve birth outcomes for API mothers should consider variations in risk by API subgroup and multiple race/ethnicity.

Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

PubMed

Khanpour Ardestani, Samaneh; Karkhaneh, Mohammad; Yu, Hai Chuan; Hydrie, Muhammad Zafar Iqbal; Vohra, Sunita

2017-12-19

Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. Of 11 816 unique references, 231 T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events. Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Factors predicting work outcome in Japanese patients with schizophrenia: role of multiple functioning levels.

PubMed

Sumiyoshi, Chika; Harvey, Philip D; Takaki, Manabu; Okahisa, Yuko; Sato, Taku; Sora, Ichiro; Nuechterlein, Keith H; Subotnik, Kenneth L; Sumiyoshi, Tomiki

2015-09-01

Functional outcomes in individuals with schizophrenia suggest recovery of cognitive, everyday, and social functioning. Specifically improvement of work status is considered to be most important for their independent living and self-efficacy. The main purposes of the present study were 1) to identify which outcome factors predict occupational functioning, quantified as work hours, and 2) to provide cut-offs on the scales for those factors to attain better work status. Forty-five Japanese patients with schizophrenia and 111 healthy controls entered the study. Cognition, capacity for everyday activities, and social functioning were assessed by the Japanese versions of the MATRICS Cognitive Consensus Battery (MCCB), the UCSD Performance-based Skills Assessment-Brief (UPSA-B), and the Social Functioning Scale Individuals' version modified for the MATRICS-PASS (Modified SFS for PASS), respectively. Potential factors for work outcome were estimated by multiple linear regression analyses (predicting work hours directly) and a multiple logistic regression analyses (predicting dichotomized work status based on work hours). ROC curve analyses were performed to determine cut-off points for differentiating between the better- and poor work status. The results showed that a cognitive component, comprising visual/verbal learning and emotional management, and a social functioning component, comprising independent living and vocational functioning, were potential factors for predicting work hours/status. Cut-off points obtained in ROC analyses indicated that 60-70% achievements on the measures of those factors were expected to maintain the better work status. Our findings suggest that improvement on specific aspects of cognitive and social functioning are important for work outcome in patients with schizophrenia.

Modelling Long Term Disability following Injury: Comparison of Three Approaches for Handling Multiple Injuries

PubMed Central

Gabbe, Belinda J.; Harrison, James E.; Lyons, Ronan A.; Jolley, Damien

2011-01-01

Background Injury is a leading cause of the global burden of disease (GBD). Estimates of non-fatal injury burden have been limited by a paucity of empirical outcomes data. This study aimed to (i) establish the 12-month disability associated with each GBD 2010 injury health state, and (ii) compare approaches to modelling the impact of multiple injury health states on disability as measured by the Glasgow Outcome Scale – Extended (GOS-E). Methods 12-month functional outcomes for 11,337 survivors to hospital discharge were drawn from the Victorian State Trauma Registry and the Victorian Orthopaedic Trauma Outcomes Registry. ICD-10 diagnosis codes were mapped to the GBD 2010 injury health states. Cases with a GOS-E score >6 were defined as “recovered.” A split dataset approach was used. Cases were randomly assigned to development or test datasets. Probability of recovery for each health state was calculated using the development dataset. Three logistic regression models were evaluated: a) additive, multivariable; b) “worst injury;” and c) multiplicative. Models were adjusted for age and comorbidity and investigated for discrimination and calibration. Findings A single injury health state was recorded for 46% of cases (1–16 health states per case). The additive (C-statistic 0.70, 95% CI: 0.69, 0.71) and “worst injury” (C-statistic 0.70; 95% CI: 0.68, 0.71) models demonstrated higher discrimination than the multiplicative (C-statistic 0.68; 95% CI: 0.67, 0.70) model. The additive and “worst injury” models demonstrated acceptable calibration. Conclusions The majority of patients survived with persisting disability at 12-months, highlighting the importance of improving estimates of non-fatal injury burden. Additive and “worst” injury models performed similarly. GBD 2010 injury states were moderately predictive of recovery 1-year post-injury. Further evaluation using additional measures of health status and functioning and comparison with the GBD 2010 disability weights will be needed to optimise injury states for future GBD studies. PMID:21984951

Why not procrastinate? Development and validation of a new active procrastination scale.

PubMed

Choi, Jin Nam; Moran, Sarah V

2009-04-01

Procrastination has been studied as a dysfunctional, self-effacing behavior that ultimately results in undesirable outcomes. However, A. H. C. Chu and J. N. Choi (2005) found a different form of procrastination (i.e., active procrastination) that leads to desirable outcomes. The construct of active procrastination has a high potential to expand the time management literature and is likely to be adopted by researchers in multiple areas of psychology. To facilitate the research on this new construct and its further integration into the literature, the authors developed and validated a new, expanded measure of active procrastination that reliably assesses its four dimensions. Using this new measure of active procrastination, they further examined its nomological network. The new 16-item measure is a critical step toward further empirical investigation of active procrastination.

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

PubMed

Kluetz, Paul G; O'Connor, Daniel J; Soltys, Katherine

2018-05-01

The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process. Copyright © 2018 Elsevier Ltd. All rights reserved.

Dehydroepiandrosterone and multiple measures of functional immunity in young adults.

PubMed

Prall, Sean P; Muehlenbein, Michael P

2015-01-01

Human immune function is strongly influenced by variation in hormone concentrations. The adrenal androgens dehydroepiandrosterone (DHEA) and dehydroepiandrosterone-sulfate (DHEA-S) are thought to be beneficial to immune function and disease resistance, but physiologically interact with testosterone and cortisol. We predict that DHEA and DHEA-S will interact with these other hormones in determining immunological outcomes. Understanding the interactive effects of these hormones will aid in understanding variability in immunocompetence and clarify discrepancies in human studies of androgen-immune interactions. Thirty-eight participants collected morning saliva over three days, from which concentrations of DHEA, DHEA-S, testosterone, and cortisol were measured, as well as salivary bacteria killing ability to measure innate immune function. From blood collection, serum was collected to measure innate immune function via a hemolytic complement assay, and whole blood collected and processed to measure proliferative responses of lymphocytes in the presence of mitogens. DHEA was negatively correlated with T cell proliferation, and positively correlated with salivary bacteria killing in male participants. Additionally, using regression models, DHEA-S was negatively associated with hemolytic complement activity, but interaction variables did not yield statistically significant relationships for any other outcome measure. While interactions with other hormones did not significantly relate with immune function measures in this sample, DHEA and DHEA-S did differentially impact multiple branches of the immune system. Generally characterized as immunosupportive in action, DHEA is shown to inhibit certain facets of innate and cell-mediated immunity, suggesting a more complex role in regulating immunocompetence. © 2015 Wiley Periodicals, Inc.

"It's the skin you're in": African-American women talk about their experiences of racism. an exploratory study to develop measures of racism for birth outcome studies.

PubMed

Nuru-Jeter, Amani; Dominguez, Tyan Parker; Hammond, Wizdom Powell; Leu, Janxin; Skaff, Marilyn; Egerter, Susan; Jones, Camara P; Braveman, Paula

2009-01-01

Stress due to experiences of racism could contribute to African-American women's adverse birth outcomes, but systematic efforts to measure relevant experiences among childbearing women have been limited. We explored the racism experiences of childbearing African-American women to inform subsequent development of improved measures for birth outcomes research. Six focus groups were conducted with a total of 40 socioeconomically diverse African-American women of childbearing age in four northern California cities. Women reported experiencing racism (1) throughout the lifecourse, with childhood experiences seeming particularly salient and to have especially enduring effects (2) directly and vicariously, particularly in relation to their children; (3) in interpersonal, institutional, and internalized forms; (4) across different life domains; (5) with active and passive responses; and (6) with pervasive vigilance, anticipating threats to themselves and their children. This exploratory study's findings support the need for measures reflecting the complexity of childbearing African-American women's racism experiences. In addition to discrete, interpersonal experiences across multiple domains and active/passive responses, which have been measured, birth outcomes research should also measure women's childhood experiences and their potentially enduring impact, perceptions of institutionalized racism and internalized negative stereotypes, vicarious experiences related to their children, vigilance in anticipating future racism events, as well as the pervasiveness and chronicity of racism exposure, all of which could be sources of ongoing stress with potentially serious implications for birth outcomes. Measures of racism addressing these issues should be developed and formally tested.

“It's The Skin You're In”: African-American Women Talk About Their Experiences of Racism. An Exploratory Study to Develop Measures of Racism for Birth Outcome Studies

PubMed Central

Nuru-Jeter, Amani; Dominguez, Tyan Parker; Hammond, Wizdom Powell; Leu, Janxin; Skaff, Marilyn; Egerter, Susan; Jones, Camara P.; Braveman, Paula

2011-01-01

Objectives Stress due to experiences of racism could contribute to African-American women's adverse birth outcomes, but systematic efforts to measure relevant experiences among childbearing women have been limited. We explored the racism experiences of childbearing African-American women to inform subsequent development of improved measures for birth outcomes research. Methods Six focus groups were conducted with a total of 40 socioeconomically diverse African-American women of childbearing age in four northern California cities. Results Women reported experiencing racism (1) throughout the lifecourse, with childhood experiences seeming particularly salient and to have especially enduring effects (2) directly and vicariously, particularly in relation to their children; (3) in interpersonal, institutional, and internalized forms; (4) across different life domains; (5) with active and passive responses; and (6) with pervasive vigilance, anticipating threats to themselves and their children. Conclusions This exploratory study's findings support the need for measures reflecting the complexity of childbearing African-American women's racism experiences. In addition to discrete, interpersonal experiences across multiple domains and active/passive responses, which have been measured, birth outcomes research should also measure women's childhood experiences and their potentially enduring impact, perceptions of institutionalized racism and internalized negative stereotypes, vicarious experiences related to their children, vigilance in anticipating future racism events, as well as the pervasiveness and chronicity of racism exposure, all of which could be sources of ongoing stress with potentially serious implications for birth outcomes. Measures of racism addressing these issues should be developed and formally tested. PMID:18463971

Intervening to reduce the risk of future disability from multiple sclerosis: are we there yet?

PubMed

Dahdaleh, Maurice; Alroughani, Raed; Aljumah, Mohammed; AlTahan, Abdulrahman; Alsharoqi, Issa; Bohlega, Saeed A; Daif, Abdulkader; Deleu, Dirk; Inshasi, Jihad; Karabudak, Rana; Sahraian, Mohammed A; Taha, Karim; Yammout, Bassem I; Zakaria, Magd

2017-10-01

Disease-modifying therapies (DMTs) delay or may prevent the progression of patients with high-risk clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (MS), and from relapsing-remitting MS to secondary progressive MS. Current evidence on the effects of DMT on disability in MS is supported by the use of the Expanded Disability Status Scale (EDSS), which is dominated by ambulation, and usually used as a secondary outcome measure. Less is known about the long-term effects of DMTs on other aspects of functional status, particularly cognition, which is a key determinant of ability to work. The time scale for measurements of disability is at most a few years, with scant data from more than 10 years of observation. Longer prospective follow-up of large numbers of patients with CIS is needed to determine whether early intervention with a DMT influences long-term disease progression. Finally, the emergence of the radiologically isolated syndrome (RIS) as a clinical entity has shifted the debate about when to intervene to an even earlier time frame. Balancing the significant side-effects associated with DMT in general and the expected outcome of pharmacologic intervention is increasingly problematic for managing patients with uncertain prognosis, as many patients may have low-risk CIS, benign MS or patients with RIS only. Preventing long-term disability in MS should be recognised more clearly as an important outcome in its own right, with disability measured more consistently with more sensitive instruments beyond the use of the EDSS.

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

Estimation of a Preference-Based Summary Score for the Patient-Reported Outcomes Measurement Information System: The PROMIS®-Preference (PROPr) Scoring System.

PubMed

Dewitt, Barry; Feeny, David; Fischhoff, Baruch; Cella, David; Hays, Ron D; Hess, Rachel; Pilkonis, Paul A; Revicki, Dennis A; Roberts, Mark S; Tsevat, Joel; Yu, Lan; Hanmer, Janel

2018-06-01

Health-related quality of life (HRQL) preference-based scores are used to assess the health of populations and patients and for cost-effectiveness analyses. The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS ® ) consists of patient-reported outcome measures developed using item response theory. PROMIS is in need of a direct preference-based scoring system for assigning values to health states. To produce societal preference-based scores for 7 PROMIS domains: Cognitive Function-Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Online survey of a US nationally representative sample ( n = 983). Preferences for PROMIS health states were elicited with the standard gamble to obtain both single-attribute scoring functions for each of the 7 PROMIS domains and a multiplicative multiattribute utility (scoring) function. The 7 single-attribute scoring functions were fit using isotonic regression with linear interpolation. The multiplicative multiattribute summary function estimates utilities for PROMIS multiattribute health states on a scale where 0 is the utility of being dead and 1 the utility of "full health." The lowest possible score is -0.022 (for a state viewed as worse than dead), and the highest possible score is 1. The online survey systematically excludes some subgroups, such as the visually impaired and illiterate. A generic societal preference-based scoring system is now available for all studies using these 7 PROMIS health domains.

SIRS score on admission and initial concentration of IL-6 as severe acute pancreatitis outcome predictors.

PubMed

Gregoric, Pavle; Pavle, Gregoric; Sijacki, Ana; Ana, Sijacki; Stankovic, Sanja; Sanja, Stankovic; Radenkovic, Dejan; Dejan, Radenkovic; Ivancevic, Nenad; Nenad, Ivancevic; Karamarkovic, Aleksandar; Aleksandar, Karamarkovic; Popovic, Nada; Nada, Popovic; Karadzic, Borivoje; Borivoje, Karadzic; Stijak, Lazar; Stefanovic, Branislav; Branislav, Stefanovic; Milosevic, Zoran; Zoran, Milosević; Bajec, Djordje; Djordje, Bajec

2010-01-01

Early recognition of severe form of acute pancreatitis is important because these patients need more agressive diagnostic and therapeutical approach an can develope systemic complications such as: sepsis, coagulopathy, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Dysfunction Syndrome (MODS), Multiple Organ Failure (MOF). To determine role of the combination of Systemic Inflammatory Response Syndrome (SIRS) score and serum Interleukin-6 (IL-6) level on admission as predictor of illness severity and outcome of Severe Acute Pancreatitis (SAP). We evaluated 234 patients with first onset of SAP appears in last twenty four hours. A total of 77 (33%) patients died. SIRS score and serum IL-6 concentration were measured in first hour after admission. In 105 patients with SIRS score 3 and higher, initial measured IL-6 levels were significantly higher than in the group of remaining 129 patients (72 +/- 67 pg/mL, vs 18 +/- 15 pg/mL). All nonsurvivals were in the first group, with SIRS score 3 and 4 and initial IL-6 concentration 113 +/- 27 pg/mL. The values of C-reactive Protein (CRP) measured after 48h, Acute Physiology and Chronic Health Evaluation (APACHE II) score on admission and Ranson score showed the similar correlation, but serum amylase level did not correlate significantly with Ranson score, IL-6 concentration and APACHE II score. The combination of SIRS score on admission and IL-6 serum concentration can be early, predictor of illness severity and outcome in SAP.

Association of Leukoaraiosis With Convalescent Rehabilitation Outcome in Patients With Ischemic Stroke.

PubMed

Senda, Joe; Ito, Keiichi; Kotake, Tomomitsu; Kanamori, Masahiko; Kishimoto, Hideo; Kadono, Izumi; Suzuki, Yoshiro; Katsuno, Masahisa; Nishida, Yoshihiro; Ishiguro, Naoki; Sobue, Gen

2016-01-01

We investigated the factors influencing inpatient convalescent rehabilitation outcomes in patients with ischemic stroke, particularly severity of leukoaraiosis on magnetic resonance imaging. Participants included 520 patients with ischemic stroke (317 men and 203 women; mean age, 72.8±8.4 years) who were transferred from acute care hospitals for inpatient convalescent rehabilitation. Ischemic stroke subtypes included lacunar infarction (n=41), atherothrombosis (n=223), artery-to-artery embolism (n=67), cardiogenic embolism (n=97), undetermined embolism (n=76), and uncategorized ischemic stroke (n=16). Leukoaraiosis was graded according to periventricular hyperintensity (PVH) and deep white matter hyperintensity on magnetic resonance imaging. Functional Independence Measure scores were assessed on admission and at discharge. Multiple regression analysis revealed that rehabilitation outcomes, measured as total Functional Independence Measure scores, were significantly associated with leukoaraiosis estimated by PVH grade. This association was observed after adjustment for factors such as severity, age, and poststroke history. In all patients, PVH grades were associated with Functional Independence Measure motor scores (P<0.001), whereas in patients with artery-to-artery embolism or cardiogenic embolism and deep white matter hyperintensity grades were associated with Functional Independence Measure cognitive scores (P<0.05). Our study revealed that the degree of leukoaraiosis was associated with inpatient convalescent rehabilitation outcome in patients with ischemic stroke. Furthermore, the PVH grade was associated with motor function outcome, whereas the deep white matter hyperintensity grade correlated with cognitive function outcome, likely because the progression patterns and anatomic backgrounds of PVH and deep white matter hyperintensity differ according to ischemic stroke subtype. © 2015 American Heart Association, Inc.

Worldwide prevalence of adverse pregnancy outcomes associated with in vitro fertilization/intracytoplasmic sperm injection among multiple births: a systematic review and meta-analysis based on cohort studies.

PubMed

Qin, Jia-Bi; Sheng, Xiao-Qi; Wang, Hua; Chen, Guo-Chong; Yang, Jing; Yu, Hong; Yang, Tu-Bao

2017-03-01

To perform a systematic review and meta-analysis of reported estimates of adverse pregnancy outcomes among multiple births conceived with in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). PubMed, Google Scholar, Cochrane Libraries and Chinese databases were searched through May 2016 for cohort studies assessing adverse pregnancy outcomes associated with IVF/ICSI multiple births. Random-effects meta-analyses were used to calculate pooled estimates of adverse pregnancy outcomes and, where appropriate, heterogeneity was explored in group-specific analyses. Sixty-four studies, with 60,210 IVF/ICSI multiple births and 146,737 spontaneously conceived multiple births, were selected for analysis. Among IVF/ICSI multiple births, the pooled estimates were 51.5% [95% confidence interval (CI): 48.7-54.3] for preterm birth, 12.1% (95% CI: 10.4-14.1) for very preterm birth, 49.8% (95% CI: 47.6-52.0) for low birth weight, 8.4% (95% CI: 7.1-9.9) for very low birth weight, 16.2% (95% CI: 12.9-20.1) for small for gestational age, 3.0% (95% CI: 2.5-3.7) for perinatal mortality and 4.7% (95% CI: 4.0-5.6) for congenital malformations. When the data were restricted to twins, the pooled estimates also showed a high prevalence of adverse outcomes. There was a similar prevalence of poor outcomes among multiple births conceived with IVF/ICSI and naturally (all P ≥ 0.0792). Significant differences in different continents, countries, and income groups were found. The IVF/ICSI multiple pregnancies have a high prevalence of adverse pregnancy outcomes. However, population-wide prospective adverse outcomes registries covering the entire world population for IVF/ICSI pregnancies are needed to determine the exact perinatal prevalence.

Construction and validation of the chronic acquired polyneuropathy patient-reported index, “CAP-PRI:” a disease-specific, health-related quality of life instrument

PubMed Central

Gwathmey, Kelly G.; Conaway, Mark R.; Seyedsadjadi, Reza; Joshi, Amruta; Barnett, Carolina; Bril, Vera; Ng, Eduardo; David, William; Gable, Karissa; Guptill, Jeffrey T.; Hobson-Webb, Lisa D.; Dineen, Jennifer; Hehir, Michael; Brannagan, Thomas H.; Byun, Esther; Adler, Margaret; Burns, Ted M.

2016-01-01

Introduction Generic health-related quality of life (HRQOL) patient-reported outcome measures have been used in patients with chronic immune-mediated polyneuropathies. We have created a disease-specific HRQOL instrument. Methods and Results The 15-item chronic acquired polyneuropathy patient-reported index (CAP-PRI) was developed and validated in multiple steps. Items were initially generated through patient and specialist input. The performance of the preliminary 20 items was analyzed from a prospective, 5-center study involving chronic immune-mediated polyneuropathy patients. Data analysis suggested modification to a 15-item scale with 3 response categories, rather than 5. The final CAP-PRI was then validated in another prospective, 5-center study. The CAP-PRI appeared to be a unidimensional outcome measure that fits the Rasch Partial Credit Model in our multicenter cohort. It correlated appropriately with the outcome measures commonly used in this patient population. Discussion The CAP-PRI is a simple, easy, disease-specific HRQOL measure that appears to be useful for clinical care and possibly also for clinical trials. PMID:26600438

Tailor-made rehabilitation approach using multiple types of hybrid assistive limb robots for acute stroke patients: A pilot study.

PubMed

Fukuda, Hiroyuki; Morishita, Takashi; Ogata, Toshiyasu; Saita, Kazuya; Hyakutake, Koichi; Watanabe, Junko; Shiota, Etsuji; Inoue, Tooru

2016-01-01

This article investigated the feasibility of a tailor-made neurorehabilitation approach using multiple types of hybrid assistive limb (HAL) robots for acute stroke patients. We investigated the clinical outcomes of patients who underwent rehabilitation using the HAL robots. The Brunnstrom stage, Barthel index (BI), and functional independence measure (FIM) were evaluated at baseline and when patients were transferred to a rehabilitation facility. Scores were compared between the multiple-robot rehabilitation and single-robot rehabilitation groups. Nine hemiplegic acute stroke patients (five men and four women; mean age 59.4 ± 12.5 years; four hemorrhagic stroke and five ischemic stroke) underwent rehabilitation using multiple types of HAL robots for 19.4 ± 12.5 days, and 14 patients (six men and eight women; mean age 63.2 ± 13.9 years; nine hemorrhagic stroke and five ischemic stroke) underwent rehabilitation using a single type of HAL robot for 14.9 ± 8.9 days. The multiple-robot rehabilitation group showed significantly better outcomes in the Brunnstrom stage of the upper extremity, BI, and FIM scores. To the best of the authors' knowledge, this is the first pilot study demonstrating the feasibility of rehabilitation using multiple exoskeleton robots. The tailor-made rehabilitation approach may be useful for the treatment of acute stroke.

Do Concomitant Cranium and Axis Injuries Predict Worse Outcome? A Trauma Database Quantitative Analysis

PubMed Central

Chittiboina, Prashant; Banerjee, Anirban Deep; Nanda, Anil

2011-01-01

We performed a trauma database analysis to identify the effect of concomitant cranial injuries on outcome in patients with fractures of the axis. We identified patients with axis fractures over a 14-year period. A binary outcome measure was used. Univariate and multiple logistic regression analysis were performed. There were 259 cases with axis fractures. Closed head injury was noted in 57% and skull base trauma in 14%. Death occurred in 17 cases (6%). Seventy-two percent had good outcome. Presence of abnormal computed tomography head findings, skull base fractures, and visceral injury was significantly associated with poor outcome. Skull base injury in association with fractures of the axis is a significant independent predictor of worse outcomes, irrespective of the severity of the head injury. We propose that presence of concomitant cranial and upper vertebral injuries require careful evaluation in view of the associated poor prognosis. PMID:22470268

Measuring Geographic Inequalities: Dealing with Multiple Health Resources by Data Envelopment Analysis.

PubMed

Dlouhý, Martin

2018-01-01

The existence of geographic differences in health resources, health expenditures, the utilization of health services, and health outcomes have been documented by a lot of studies from various countries of the world. In a publicly financed health system, equal access is one of the main objectives of the national health policy. That is why inequalities in the geographic allocation of health resources are an important health policy issue. Measures of inequality express the complexity of variation in the observed variable by a single number, and there is a variety of inequality measures available. The objective of this study is to develop a measure of the geographic inequality in the case of multiple health resources. The measure uses data envelopment analysis (DEA), which is a non-parametric method of production function estimation, to transform multiple resources into a single virtual health resource. The study shows that the DEA originally developed for measuring efficiency can be used successfully to measure inequality. For the illustrative purpose, the inequality measure is calculated for the Czech Republic. The values of separate Robin Hood Indexes (RHIs) are 6.64% for physicians and 3.96% for nurses. In the next step, we use combined RHI for both health resources. Its value 5.06% takes into account that the combinations of two health resources serve regional populations.

Two pathways through adversity: Predicting well-being and housing outcomes among homeless service users.

PubMed

Walter, Zoe C; Jetten, Jolanda; Dingle, Genevieve A; Parsell, Cameron; Johnstone, Melissa

2016-06-01

People who experience homelessness face many challenges and disadvantages that negatively impact health and well-being and form barriers to achieving stable housing. Further, people who are homeless often have limited social connections and support. Building on previous research that has shown the beneficial effect of group identification on health and well-being, the current study explores the relationship between two social identity processes - multiple group memberships and service identification - and well-being and positive housing outcomes. Measures were collected from 76 participants while they were residing in a homeless accommodation service (T1) and again 2-4 weeks after leaving the service (or 3 months after T1 if participants had not left the service). Mediation analyses revealed that multiple group memberships and service identification at T1 independently predicted well-being at T2 indirectly, via social support. Further, both social identity processes also indirectly predicted housing outcomes via social support. The implications of these findings are twofold. First, while belonging to multiple social groups may provide a pathway to gaining social support and well-being, group belonging may not necessarily be beneficial to achieve stable housing. Second, fostering identification with homeless services may be particularly important as a source of support that contributes to well-being. © 2015 The British Psychological Society.

[Is it beneficial to involve family member? A literature review to psychosocial interventions in family-centered nursing].

PubMed

Mahrer-Imhof, Romy; Bruylands, Michelle

2014-10-01

Families influence the wellbeing of patients and are influenced by illness themselves. Involving caregivers in patient care was examined in multiple studies. The aim of this literature review was to investigate the different approaches to family-centered interventions (FI) and to evaluate the tested outcomes as well as the detected effect sizes. This search for a systematic literature review of randomized controlled trials and metaanalyses revealed three Meta Analyses with studies until 2007 and six randomized controlled studies from 2007 to 2012. FI showed small to middle positive effects on the outcomes depression, mental health, anxiety of patients and family members and on caregiver burden. A conclusive effect on physical health could not be shown. The results strongly depend on the enrolled patient population, the targeted participants of FI, as well as the focus, type and dose of FI. The studies showed vast differences in the length and type of intervention, the target population and the selection of outcomes. Comparing outcomes was difficult due to the use of different outcome measures. Further research with various populations, different FI intensity but with same, valid outcome measures is needed.

Interventional effects for mediation analysis with multiple mediators

PubMed Central

Vansteelandt, Stijn; Daniel, Rhian M.

2016-01-01

The mediation formula for the identification of natural (in)direct effects has facilitated mediation analyses that better respect the nature of the data, with greater consideration of the need for confounding control. The default assumptions on which it relies are strong, however. In particular, they are known to be violated when confounders of the mediator–outcome association are affected by the exposure. This complicates extensions of counterfactual-based mediation analysis to settings that involve repeatedly measured mediators, or multiple correlated mediators. VanderWeele, Vansteelandt, and Robins21 introduced so-called interventional (in)direct effects. These can be identified under much weaker conditions than natural (in)direct effects, but have the drawback of not adding up to the total effect. In this article, we adapt their proposal in order to achieve an exact decomposition of the total effect, and extend it to the multiple mediator setting. Interestingly, the proposed effects capture the path-specific effects of an exposure on an outcome that are mediated by distinct mediators, even when – as often – the structural dependence between the multiple mediators is unknown; for instance, when the direction of the causal effects between the mediators is unknown, or there may be unmeasured common causes of the mediators. PMID:27922534

Interventional Effects for Mediation Analysis with Multiple Mediators.

PubMed

Vansteelandt, Stijn; Daniel, Rhian M

2017-03-01

The mediation formula for the identification of natural (in)direct effects has facilitated mediation analyses that better respect the nature of the data, with greater consideration of the need for confounding control. The default assumptions on which it relies are strong, however. In particular, they are known to be violated when confounders of the mediator-outcome association are affected by the exposure. This complicates extensions of counterfactual-based mediation analysis to settings that involve repeatedly measured mediators, or multiple correlated mediators. VanderWeele, Vansteelandt, and Robins introduced so-called interventional (in)direct effects. These can be identified under much weaker conditions than natural (in)direct effects, but have the drawback of not adding up to the total effect. In this article, we adapt their proposal to achieve an exact decomposition of the total effect, and extend it to the multiple mediator setting. Interestingly, the proposed effects capture the path-specific effects of an exposure on an outcome that are mediated by distinct mediators, even when-as often-the structural dependence between the multiple mediators is unknown, for instance, when the direction of the causal effects between the mediators is unknown, or there may be unmeasured common causes of the mediators.

Correspondence between Single versus Daily Preference Assessment Outcomes and Reinforcer Efficacy under Progressive-Ratio Schedules

ERIC Educational Resources Information Center

Call, Nathan A.; Trosclair-Lasserre, Nicole M.; Findley, Addie J.; Reavis, Andrea R.; Shillingsburg, M. Alice

2012-01-01

Research has suggested that a daily multiple-stimulus-without-replacement (MSWO) preference assessment may be more sensitive to changes in preference than other assessment formats, thereby resulting in greater correspondence with reinforcer efficacy over time (DeLeon et al., 2001). However, most prior studies have measured reinforcer efficacy…

Attachment Style, Social Support, and Coping as Psychosocial Correlates of Happiness in Persons with Spinal Cord Injuries

ERIC Educational Resources Information Center

Wilson, Lisa; Catalano, Denise; Sung, Connie; Phillips, Brian; Chou, Chih-Chin; Chan, Jacob Yui Chung; Chan, Fong

2013-01-01

Objective: To examine the roles of attachment, social support, and coping as psychosocial correlates in predicting happiness in people with spinal cord injuries. Design: Quantitative descriptive research design using multiple regression and correlation techniques. Participants: 274 individuals with spinal cord injuries. Outcome Measures: Happiness…

Evaluation of Bully-Proofing Your School as an Elementary School Antibullying Intervention

ERIC Educational Resources Information Center

Menard, Scott; Grotpeter, Jennifer K.

2014-01-01

Bully-Proofing Your School (BPYS), a school-based intervention program designed to reduce bullying and school violence, is evaluated for its impact on bullying and related aggressive behaviors in a multiple nonequivalent control group, pretest-posttest design with ex ante selection of treatment and comparison groups. Outcome measures included…

Removing a Nail from the Boot Camp Coffin: An Outcome Evaluation of Minnesota's Challenge Incarceration Program

ERIC Educational Resources Information Center

Duwe, Grant; Kerschner, Deborah

2008-01-01

Using a retrospective, quasiexperimental design, this study evaluates Minnesota's Challenge Incarceration Program (CIP), examining whether it has lowered recidivism and saved money. In addition to utilizing a lengthy follow-up period and multiple measures of recidivism and participation, a multistage sampling design was employed to create a…

A Standardized Mean Difference Effect Size for Multiple Baseline Designs across Individuals

ERIC Educational Resources Information Center

Hedges, Larry V.; Pustejovsky, James E.; Shadish, William R.

2013-01-01

Single-case designs are a class of research methods for evaluating treatment effects by measuring outcomes repeatedly over time while systematically introducing different condition (e.g., treatment and control) to the same individual. The designs are used across fields such as behavior analysis, clinical psychology, special education, and…

Maternal-Related Predictors of Self-Regulation among Low-Income Youth

ERIC Educational Resources Information Center

Crossley, Isabelle A.; Buckner, John C.

2012-01-01

The association between self-regulation and various adaptive outcomes has become a topic of growing interest to researchers. Yet, there is not much research on predictors of self-regulation in children. Using a cross-sectional design and an array of psychometrically sound scales and measures from multiple informants, this study examined whether…

Multiple Methods for Identifying Outcomes of a High Challenge Adventure Activity

ERIC Educational Resources Information Center

Davidson, Curt; Ewert, Alan; Chang, Yun

2016-01-01

The purpose of this study was to provide insight into what occurs in moments of high challenge within participants during an outdoor adventure education (OAE) program. Given the inherent risk and remote locations often associated with OAE programs, it has remained challenging to measure selected psychological constructs while the program is taking…

Does Narrative Exposure Therapy Reduce PTSD in Survivors of Mass Violence?

ERIC Educational Resources Information Center

McPherson, Jane

2012-01-01

Purpose: This review examines the effectiveness of narrative exposure therapy (NET) , a short-term intervention for posttraumatic stress disorder (PTSD) in survivors of mass violence and torture, who have often suffered multiple traumas over several years. Methods: Randomized control trials were reviewed if they measured PTSD outcome and were…

Neurological Outcome Scale for Traumatic Brain Injury: III. Criterion-Related Validity and Sensitivity to Change in the NABIS Hypothermia-II Clinical Trial

PubMed Central

Wilde, Elisabeth A.; Moretti, Paolo; MacLeod, Marianne C.; Pedroza, Claudia; Drever, Pamala; Fourwinds, Sierra; Frisby, Melisa L.; Beers, Sue R.; Scott, James N.; Hunter, Jill V.; Traipe, Elfrides; Valadka, Alex B.; Okonkwo, David O.; Zygun, David A.; Puccio, Ava M.; Clifton, Guy L.

2013-01-01

Abstract The Neurological Outcome Scale for Traumatic Brain Injury (NOS-TBI) is a measure assessing neurological functioning in patients with TBI. We hypothesized that the NOS-TBI would exhibit adequate concurrent and predictive validity and demonstrate more sensitivity to change, compared with other well-established outcome measures. We analyzed data from the National Acute Brain Injury Study: Hypothermia-II clinical trial. Participants were 16–45 years of age with severe TBI assessed at 1, 3, 6, and 12 months postinjury. For analysis of criterion-related validity (concurrent and predictive), Spearman's rank-order correlations were calculated between the NOS-TBI and the Glasgow Outcome Scale (GOS), GOS-Extended (GOS-E), Disability Rating Scale (DRS), and Neurobehavioral Rating Scale-Revised (NRS-R). Concurrent validity was demonstrated through significant correlations between the NOS-TBI and GOS, GOS-E, DRS, and NRS-R measured contemporaneously at 3, 6, and 12 months postinjury (all p<0.0013). For prediction analyses, the multiplicity-adjusted p value using the false discovery rate was <0.015. The 1-month NOS-TBI score was a significant predictor of outcome in the GOS, GOS-E, and DRS at 3 and 6 months postinjury (all p<0.015). The 3-month NOS-TBI significantly predicted GOS, GOS-E, DRS, and NRS-R outcomes at 6 and 12 months postinjury (all p<0.0015). Sensitivity to change was analyzed using Wilcoxon's signed rank-sum test of subsamples demonstrating no change in the GOS or GOS-E between 3 and 6 months. The NOS-TBI demonstrated higher sensitivity to change, compared with the GOS (p<0.038) and GOS-E (p<0.016). In summary, the NOS-TBI demonstrated adequate concurrent and predictive validity as well as sensitivity to change, compared with gold-standard outcome measures. The NOS-TBI may enhance prediction of outcome in clinical practice and measurement of outcome in TBI research. PMID:23617608

Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study.

PubMed

Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

2017-10-04

Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.

Impact of the Alzheimer's Disease Neuroimaging Initiative, 2004 to 2014.

PubMed

Weiner, Michael W; Veitch, Dallas P; Aisen, Paul S; Beckett, Laurel A; Cairns, Nigel J; Cedarbaum, Jesse; Donohue, Michael C; Green, Robert C; Harvey, Danielle; Jack, Clifford R; Jagust, William; Morris, John C; Petersen, Ronald C; Saykin, Andrew J; Shaw, Leslie; Thompson, Paul M; Toga, Arthur W; Trojanowski, John Q

2015-07-01

The Alzheimer's Disease Neuroimaging Initiative (ADNI) was established in 2004 to facilitate the development of effective treatments for Alzheimer's disease (AD) by validating biomarkers for AD clinical trials. We searched for ADNI publications using established methods. ADNI has (1) developed standardized biomarkers for use in clinical trial subject selection and as surrogate outcome measures; (2) standardized protocols for use across multiple centers; (3) initiated worldwide ADNI; (4) inspired initiatives investigating traumatic brain injury and post-traumatic stress disorder in military populations, and depression, respectively, as an AD risk factor; (5) acted as a data-sharing model; (6) generated data used in over 600 publications, leading to the identification of novel AD risk alleles, and an understanding of the relationship between biomarkers and AD progression; and (7) inspired other public-private partnerships developing biomarkers for Parkinson's disease and multiple sclerosis. ADNI has made myriad impacts in its first decade. A competitive renewal of the project in 2015 would see the use of newly developed tau imaging ligands, and the continued development of recruitment strategies and outcome measures for clinical trials. Copyright © 2015 The Alzheimer's Association. All rights reserved.

Impact of the Alzheimer’s Disease Neuroimaging Initiative, 2004 to 2014

PubMed Central

Weiner, Michael W.; Veitch, Dallas P.; Aisen, Paul S.; Beckett, Laurel A.; Cairns, Nigel J.; Cedarbaum, Jesse; Donohue, Michael C.; Green, Robert C.; Harvey, Danielle; Jack, Clifford R.; Jagust, William; Morris, John C.; Petersen, Ronald C.; Saykin, Andrew J.; Shaw, Leslie; Thompson, Paul M.; Toga, Arthur W.; Trojanowski, John Q.

2015-01-01

Introduction The Alzheimer’s Disease Neuroimaging Initiative (ADNI) was established in 2004 to facilitate the development of effective treatments for Alzheimer’s disease (AD) by validating biomarkers for AD clinical trials. Methods We searched for ADNI publications using established methods. Results ADNI has (1) developed standardized biomarkers for use in clinical trial subject selection and as surrogate outcome measures; (2) standardized protocols for use across multiple centers; (3) initiated worldwide ADNI; (4) inspired initiatives investigating traumatic brain injury and post-traumatic stress disorder in military populations, and depression, respectively, as an AD risk factor; (5) acted as a data-sharing model; (6) generated data used in over 600 publications, leading to the identification of novel AD risk alleles, and an understanding of the relationship between biomarkers and AD progression; and (7) inspired other public-private partnerships developing biomarkers for Parkinson’s disease and multiple sclerosis. Discussion ADNI has made myriad impacts in its first decade. A competitive renewal of the project in 2015 would see the use of newly developed tau imaging ligands, and the continued development of recruitment strategies and outcome measures for clinical trials. PMID:26194320

Research design issues for evaluating complex multicomponent interventions in neighborhoods and communities.

PubMed

Komro, Kelli A; Flay, Brian R; Biglan, Anthony; Wagenaar, Alexander C

2016-03-01

Major advances in population health will not occur unless we translate existing knowledge into effective multicomponent interventions, implement and maintain these in communities, and develop rigorous translational research and evaluation methods to ensure continual improvement and sustainability. We discuss challenges and offer approaches to evaluation that are key for translational research stages 3 to 5 to advance optimized adoption, implementation, and maintenance of effective and replicable multicomponent strategies. The major challenges we discuss concern (a) multiple contexts of evaluation/research, (b) complexity of packages of interventions, and (c) phases of evaluation/research questions. We suggest multiple alternative research designs that maintain rigor but accommodate these challenges and highlight the need for measurement systems. Longitudinal data collection and a standardized continuous measurement system are fundamental to the evaluation and refinement of complex multicomponent interventions. To be useful to T3-T5 translational research efforts in neighborhoods and communities, such a system would include assessments of the reach, implementation, effects on immediate outcomes, and effects of the comprehensive intervention package on more distal health outcomes.

Imaging outcome measures for progressive multiple sclerosis trials

PubMed Central

Moccia, Marcello; de Stefano, Nicola; Barkhof, Frederik

2017-01-01

Imaging markers that are reliable, reproducible and sensitive to neurodegenerative changes in progressive multiple sclerosis (MS) can enhance the development of new medications with a neuroprotective mode-of-action. Accordingly, in recent years, a considerable number of imaging biomarkers have been included in phase 2 and 3 clinical trials in primary and secondary progressive MS. Brain lesion count and volume are markers of inflammation and demyelination and are important outcomes even in progressive MS trials. Brain and, more recently, spinal cord atrophy are gaining relevance, considering their strong association with disability accrual; ongoing improvements in analysis methods will enhance their applicability in clinical trials, especially for cord atrophy. Advanced magnetic resonance imaging (MRI) techniques (e.g. magnetization transfer ratio (MTR), diffusion tensor imaging (DTI), spectroscopy) have been included in few trials so far and hold promise for the future, as they can reflect specific pathological changes targeted by neuroprotective treatments. Position emission tomography (PET) and optical coherence tomography have yet to be included. Applications, limitations and future perspectives of these techniques in clinical trials in progressive MS are discussed, with emphasis on measurement sensitivity, reliability and sample size calculation. PMID:29041865

Magnetic resonance spectroscopic determination of a neuronal and axonal marker in white matter predicts reversibility of deficits in secondary normal pressure hydrocephalus

PubMed Central

Shiino, A; Nishida, Y; Yasuda, H; Suzuki, M; Matsuda, M; Inubushi, T

2004-01-01

Background: Normal pressure hydrocephalus (NPH) is considered to be a treatable form of dementia, because cerebrospinal fluid (CSF) shunting can lessen symptoms. However, neuroimaging has failed to predict when shunting will be effective. Objective: To investigate whether 1H (proton) magnetic resonance (MR) spectroscopy could predict functional outcome in patients after shunting. Methods: Neurological state including Hasegawa's dementia scale, gait, continence, and the modified Rankin scale were evaluated in 21 patients with secondary NPH who underwent ventriculo-peritoneal shunting. Outcomes were measured postoperatively at one and 12 months and were classified as excellent, fair, or poor. MR spectra were obtained from left hemispheric white matter. Results: Significant preoperative differences in N-acetyl aspartate (NAA)/creatine (Cr) and NAA/choline (Cho) were noted between patients with excellent and poor outcome at one month (p = 0.0014 and 0.0036, respectively). Multiple regression analysis linked higher preoperative NAA/Cr ratio, gait score, and modified Rankin scale to better one month outcome. Predictive value, sensitivity, and specificity for excellent outcome following shunting were 95.2%, 100%, and 87.5%. Multiple regression analysis indicated that NAA/Cho had the best predictive value for one year outcome (p = 0.0032); predictive value, sensitivity, and specificity were 89.5%, 90.0%, and 88.9%. Conclusions: MR spectroscopy predicted long term post-shunting outcomes in patients with secondary NPH, and it would be a useful assessment tool before lumbar drainage. PMID:15258216

Heart Failure Update: Chronic Disease Management Programs.

PubMed

Fountain, Lorna B

2016-03-01

With high mortality and readmission rates among patients with heart failure (HF), multiple disease management models have been and continue to be tested, with mixed results. Early postdischarge care improves outcomes for patients. Telemonitoring also can assist in reducing mortality and HF-related hospitalizations. Office-based team care improves patient outcomes, with important components including rapid access to physicians, partnerships with clinical pharmacists, education, monitoring, and support. Pay-for-performance measures developed for HF, primarily use of angiotensin-converting enzyme inhibitors and beta blockers, also improve patient outcomes, but the influence of adherence to other measures has been minimal. Evaluating comorbid conditions, including diabetes and hypertension, and making drug adjustments for patients with HF to include blood pressure control and use of metformin, when possible, can reduce mortality and morbidity. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

Observational attachment theory-based parenting measures predict children's attachment narratives independently from social learning theory-based measures.

PubMed

Matias, Carla; O'Connor, Thomas G; Futh, Annabel; Scott, Stephen

2014-01-01

Conceptually and methodologically distinct models exist for assessing quality of parent-child relationships, but few studies contrast competing models or assess their overlap in predicting developmental outcomes. Using observational methodology, the current study examined the distinctiveness of attachment theory-based and social learning theory-based measures of parenting in predicting two key measures of child adjustment: security of attachment narratives and social acceptance in peer nominations. A total of 113 5-6-year-old children from ethnically diverse families participated. Parent-child relationships were rated using standard paradigms. Measures derived from attachment theory included sensitive responding and mutuality; measures derived from social learning theory included positive attending, directives, and criticism. Child outcomes were independently-rated attachment narrative representations and peer nominations. Results indicated that Attachment theory-based and Social Learning theory-based measures were modestly correlated; nonetheless, parent-child mutuality predicted secure child attachment narratives independently of social learning theory-based measures; in contrast, criticism predicted peer-nominated fighting independently of attachment theory-based measures. In young children, there is some evidence that attachment theory-based measures may be particularly predictive of attachment narratives; however, no single model of measuring parent-child relationships is likely to best predict multiple developmental outcomes. Assessment in research and applied settings may benefit from integration of different theoretical and methodological paradigms.

Non-invasive prediction of catheter ablation outcome in persistent atrial fibrillation by fibrillatory wave amplitude computation in multiple electrocardiogram leads.

PubMed

Zarzoso, Vicente; Latcu, Decebal G; Hidalgo-Muñoz, Antonio R; Meo, Marianna; Meste, Olivier; Popescu, Irina; Saoudi, Nadir

2016-12-01

Catheter ablation (CA) of persistent atrial fibrillation (AF) is challenging, and reported results are capable of improvement. A better patient selection for the procedure could enhance its success rate while avoiding the risks associated with ablation, especially for patients with low odds of favorable outcome. CA outcome can be predicted non-invasively by atrial fibrillatory wave (f-wave) amplitude, but previous works focused mostly on manual measures in single electrocardiogram (ECG) leads only. To assess the long-term prediction ability of f-wave amplitude when computed in multiple ECG leads. Sixty-two patients with persistent AF (52 men; mean age 61.5±10.4years) referred for CA were enrolled. A standard 1-minute 12-lead ECG was acquired before the ablation procedure for each patient. F-wave amplitudes in different ECG leads were computed by a non-invasive signal processing algorithm, and combined into a mutivariate prediction model based on logistic regression. During an average follow-up of 13.9±8.3months, 47 patients had no AF recurrence after ablation. A lead selection approach relying on the Wald index pointed to I, V1, V2 and V5 as the most relevant ECG leads to predict jointly CA outcome using f-wave amplitudes, reaching an area under the curve of 0.854, and improving on single-lead amplitude-based predictors. Analysing the f-wave amplitude in several ECG leads simultaneously can significantly improve CA long-term outcome prediction in persistent AF compared with predictors based on single-lead measures. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Medication adherence and tolerability of Alzheimer's disease medications: study protocol for a randomized controlled trial.

PubMed

Campbell, Noll L; Dexter, Paul; Perkins, Anthony J; Gao, Sujuan; Li, Lang; Skaar, Todd C; Frame, Amie; Hendrie, Hugh C; Callahan, Chris M; Boustani, Malaz A

2013-05-04

The class of acetylcholinesterase inhibitors (ChEI), including donepezil, rivastigmine, and galantamine, have similar efficacy profiles in patients with mild to moderate Alzheimer's disease (AD). However, few studies have evaluated adherence to these agents. We sought to prospectively capture the rates and reasons for nonadherence to ChEI and determine factors influencing tolerability and adherence. We designed a pragmatic randomized clinical trial to evaluate the adherence to ChEIs among older adults with AD. Participants include AD patients receiving care within memory care practices in the greater Indianapolis area. Participants will be followed at 6-week intervals up to 18 weeks to measure the primary outcome of ChEI discontinuation and adherence rates and secondary outcomes of behavioral and psychological symptoms of dementia. The primary outcome will be assessed through two methods, a telephone interview of an informal caregiver and electronic medical record data captured from each healthcare system through a regional health information exchange. The secondary outcome will be measured by the Healthy Aging Brain Care Monitor and the Neuropsychiatric Inventory. In addition, the trial will conduct an exploratory evaluation of the pharmacogenomic signatures for the efficacy and the adverse effect responses to ChEIs. We hypothesized that patient-specific factors, including pharmacogenomics and pharmacokinetic characteristics, may influence the study outcomes. This pragmatic trial will engage a diverse population from multiple memory care practices to evaluate the adherence to and tolerability of ChEIs in a real world setting. Engaging participants from multiple healthcare systems connected through a health information exchange will capture valuable clinical and non-clinical influences on the patterns of utilization and tolerability of a class of medications with a high rate of discontinuation. Clinicaltrials.gov: NCT01362686.

Prognosis of depressive disorders in the general population- results from the longitudinal Finnish Health 2011 Study.

PubMed

Markkula, Niina; Härkänen, Tommi; Nieminen, Tarja; Peña, Sebastián; Mattila, Aino K; Koskinen, Seppo; Saarni, Samuli I; Suvisaari, Jaana

2016-01-15

Depressive disorders are among the most pressing public health challenges worldwide. Yet, not enough is known about their long-term outcomes. This study examines the course and predictors of different outcomes of depressive disorders in an eleven-year follow-up of a general population sample. In a nationally representative sample of Finns aged 30 and over (BRIF8901), major depressive disorder (MDD) and dysthymia were diagnosed with the Composite International Diagnostic Interview (M-CIDI) in 2000. The participants were followed up in 2011 (n=5733). Outcome measures were diagnostic status, mortality, depressive symptoms and health-related quality of life. Multiple imputation (MI) was used to account for nonresponse. At follow-up, 33.8% of persons with baseline MDD and 42.6% with baseline dysthymia received a diagnosis of depressive, anxiety or alcohol use disorder. Baseline severity of disorder, measured by the Beck Depression Inventory, predicted both persistence of depressive disorder and increased mortality risk. In addition, being never-married, separated or widowed predicted persistence of depressive disorders, whereas somatic and psychiatric comorbidity, childhood adversities and lower social capital did not. Those who received no psychiatric diagnosis at follow-up still had residual symptoms and lower quality of life. We only had one follow-up point at eleven years, and did not collect information on the subjects' health during the follow-up period. Depressive disorders in the general population are associated with multiple negative outcomes. Severity of index episode is the strongest predictor of negative outcomes. More emphasis should be placed on addressing the long-term consequences of depression. Copyright © 2015 Elsevier B.V. All rights reserved.

Analyses of group sequential clinical trials.

PubMed

Koepcke, W

1989-12-01

In the first part of this article the methodology of group sequential plans is reviewed. After introducing the basic definition of such plans the main properties are shown. At the end of this section three different plans (Pocock, O'Brien-Fleming, Koepcke) are compared. In the second part of the article some unresolved issues and recent developments in the application of group sequential methods to long-term controlled clinical trials are discussed. These include deviation from the assumptions, life table methods, multiple-arm clinical trials, multiple outcome measures, and confidence intervals.

Developing a Web-Based Nursing Practice and Research Information Management System: A Pilot Study.

PubMed

Choi, Jeeyae; Lapp, Cathi; Hagle, Mary E

2015-09-01

Many hospital information systems have been developed and implemented to collect clinical data from the bedside and have used the information to improve patient care. Because of a growing awareness that the use of clinical information improves quality of care and patient outcomes, measuring tools (electronic and paper based) have been developed, but most of them require multiple steps of data collection and analysis. This necessitated the development of a Web-based Nursing Practice and Research Information Management System that processes clinical nursing data to measure nurses' delivery of care and its impact on patient outcomes and provides useful information to clinicians, administrators, researchers, and policy makers at the point of care. This pilot study developed a computer algorithm based on a falls prevention protocol and programmed the prototype Web-based Nursing Practice and Research Information Management System. It successfully measured performance of nursing care delivered and its impact on patient outcomes successfully using clinical nursing data from the study site. Although Nursing Practice and Research Information Management System was tested with small data sets, results of study revealed that it has the potential to measure nurses' delivery of care and its impact on patient outcomes, while pinpointing components of nursing process in need of improvement.

Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT)

PubMed Central

Cleanthous, Sophie; Kinter, Elizabeth; Marquis, Patrick; Petrillo, Jennifer; You, Xiaojun; Wakeford, Craig; Sabatella, Guido

2017-01-01

Background Study objectives were to evaluate the Multiple Sclerosis Impact Scale (MSIS-29) and explore an optimized scoring structure based on empirical post-hoc analyses of data from the Phase III ADVANCE clinical trial. Methods ADVANCE MSIS-29 data from six time-points were analyzed in a sample of patients with relapsing–remitting multiple sclerosis (RRMS). Rasch Measurement Theory (RMT) analysis was undertaken to examine three broad areas: sample-to-scale targeting, measurement scale properties, and sample measurement validity. Interpretation of results led to an alternative MSIS-29 scoring structure, further evaluated alongside responsiveness of the original and revised scales at Week 48. Results RMT analysis provided mixed evidence for Physical and Psychological Impact scales that were sub-optimally targeted at the lower functioning end of the scales. Their conceptual basis could also stand to improve based on item fit results. The revised MSIS-29 rescored scales improved but did not resolve the measurement scale properties and targeting of the MSIS-29. In two out of three revised scales, responsiveness analysis indicated strengthened ability to detect change. Conclusion The revised MSIS-29 provides an initial evidence-based improved patient-reported outcome (PRO) instrument for evaluating the impact of MS. Revised scoring improves conceptual clarity and interpretation of scores by refining scale structure to include Symptoms, Psychological Impact, and General Limitations. Clinical trial ADVANCE (ClinicalTrials.gov identifier NCT00906399). PMID:29104758

Translational and regulatory challenges for exon skipping therapies.

PubMed

Aartsma-Rus, Annemieke; Ferlini, Alessandra; Goemans, Nathalie; Pasmooij, Anna M G; Wells, Dominic J; Bushby, Katerine; Vroom, Elizabeth; Balabanov, Pavel

2014-10-01

Several translational challenges are currently impeding the therapeutic development of antisense-mediated exon skipping approaches for rare diseases. Some of these are inherent to developing therapies for rare diseases, such as small patient numbers and limited information on natural history and interpretation of appropriate clinical outcome measures. Others are inherent to the antisense oligonucleotide (AON)-mediated exon skipping approach, which employs small modified DNA or RNA molecules to manipulate the splicing process. This is a new approach and only limited information is available on long-term safety and toxicity for most AON chemistries. Furthermore, AONs often act in a mutation-specific manner, in which case multiple AONs have to be developed for a single disease. A workshop focusing on preclinical development, trial design, outcome measures, and different forms of marketing authorization was organized by the regulatory models and biochemical outcome measures working groups of Cooperation of Science and Technology Action: "Networking towards clinical application of antisense-mediated exon skipping for rare diseases." The workshop included participants from patient organizations, academia, and members of staff from the European Medicine Agency and Medicine Evaluation Board (the Netherlands). This statement article contains the key outcomes of this meeting.

The use of computer adaptive tests in outcome assessments following upper limb trauma.

PubMed

Jayakumar, P; Overbeek, C; Vranceanu, A-M; Williams, M; Lamb, S; Ring, D; Gwilym, S

2018-06-01

Aims Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation. Materials and Methods A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to "CATs", "orthopaedics", "trauma", and "anatomical regions". Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg istered (PROSPERO: CRD42016053886). Results A total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing. Conclusion Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures. Cite this article: Bone Joint J 2018;100-B:693-702.

Radiological and clinical predictors of long-term outcome in rotator cuff calcific tendinitis.

PubMed

de Witte, Pieter Bas; van Adrichem, Raymond A; Selten, Jasmijn W; Nagels, Jochem; Reijnierse, M; Nelissen, Rob G H H

2016-10-01

Knowledge on the epidemiology and long-term course of rotator cuff calcific tendinitis (RCCT) is scarce. We assessed demographics, radiological characteristics, and their association with long-term outcomes in a large patient group. Baseline demographics, radiological characteristics and treatment were recorded in 342 patients. Interobserver agreement of radiological measures was analyzed. Long-term outcome was evaluated with questionnaires (WORC, DASH). The association of baseline characteristics with outcome was assessed. Mean age was 49.0 (SD = 10.0), and 59.5 % were female. The dominant arm was affected in 66.0 %, and 21.3 % had bilateral disease. Calcifications were on average 18.7 mm (SD = 10.1, ICC = 0.84 (p < 0.001)) and located 10.1 mm (SD = 11.8) medially to the acromion (ICC = 0.77 (p < 0.001)). Gärtner type I calcifications were found in 32.1 % (Kappa = 0.47 (p < 0.001)). After 14 years (SD = 7.1) of follow-up, median WORC was 72.5 (range, 3.0-100.0; WORC < 60 in 42 %) and median DASH 17.0 (range, 0.0-82.0). Female gender, dominant arm involvement, bilateral disease, longer duration of symptoms, and multiple calcifications were associated with inferior WORC. DASH results were similar. Many subjects have persisting shoulder complaints years after diagnosis, regardless of treatment. Female gender, dominant arm involvement, bilateral disease, longer duration of symptoms, and multiple calcifications were associated with inferior outcome. Radiological measures had moderate-to-good reliability and no prognostic value. • Most RCCT studies report on short-term outcome and/or small patients groups. • In this large, long-term observational study, RCCT appeared to not be self-limiting in many subjects. • Negative prognostic factors included female gender, more calcifications, dominant arm affected, and longer duration of symptoms. • Interobserver agreement of general radiological RCCT measures is moderate to good. • More rigorous diagnostics and treatment might be needed in specific RCCT cases.

Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

PubMed

Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

2015-07-01

Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Early childhood growth and cognitive outcomes: Findings from the MAL-ED study.

PubMed

Scharf, Rebecca J; Rogawski, Elizabeth T; Murray-Kolb, Laura E; Maphula, Angelina; Svensen, Erling; Tofail, Fahmida; Rasheed, Muneera; Abreu, Claudia; Vasquez, Angel Orbe; Shrestha, Rita; Pendergast, Laura; Mduma, Estomih; Koshy, Beena; Conaway, Mark R; Platts-Mills, James A; Guerrant, Richard L; DeBoer, Mark D

2018-02-02

Although many studies around the world hope to measure or improve developmental progress in children to promote community flourishing and productivity, growth is sometimes used as a surrogate because cognitive skills are more difficult to measure. Our objective was to assess how childhood measures of anthropometry correlate with measures of child development in low-income settings with high prevalence of poor nutrition and enteric disease, to inform studies considering growth outcomes in the absence of direct child developmental skill assessment. Children from the MAL-ED study were followed from birth to 24 months of age in field sites in 8 low- and middle-income countries across 3 continents. Monthly weight, length, and head circumference measurements were performed. At 24 months, the Bayley Scales of Infant and Toddler Development was administered. We correlated cognitive measures at 24 months with anthropometric measurements from birth to 2 years comparing 3 constructs: absolute attained monthly measures, summative difference in measures from the mean growth curve, and rate of change in measures. Growth faltering at multiple time periods is related to Bayley cognitive outcomes at 24 months. Birthweight, overall growth by 18-24 months, and rate of growth in the 6- to 18-month period were most associated with 24-month developmental scores. In this study, head circumference measurements, compared with length, was more closely linked to cognitive scores at 24 months. Notably, all studies between growth and cognitive outcomes exhibited low r 2 values (0.001-0.049). Anthropometric measures, particularly head circumference, were related to cognitive development, although explaining a low percent of variance. When feasible, direct measures of child development may be more useful. © 2018 John Wiley & Sons Ltd.

Systematic review: handwashing behaviour in low- to middle-income countries: outcome measures and behaviour maintenance.

PubMed

Vindigni, Stephen M; Riley, Patricia L; Jhung, Michael

2011-04-01

To describe global approaches to handwashing research in low- and middle-income communities, schools and health care settings using behavioural outcome measurement and temporal study design. Peer-reviewed and grey literature was screened for handwashing studies that evaluated behaviour change. Relevant articles were assessed by their research approach, including the investigator's selected outcome measure and time frame of various study components (e.g., formative research, intervention and evaluation). The initial search yielded 527 relevant articles. After application of exclusion criteria, we identified 27 unique studies (30 total articles). Of the 27 articles, most were focused in the community setting. Fifteen (56%) documented observed handwashing behaviour, while 18 (67%) used proxy measures (e.g., soap presence, diarrhoea) and 14 (52%) used self-reported behaviour. Several studies used multiple outcome measures. While all studies had an evaluation of behaviour change, there was a dearth of studies that evaluated long-term maintenance of behaviour change after the intervention's conclusion. While the literature is replete with a variety of handwashing studies in community, school and health care settings, none have been able to definitively document long-term behaviour change, thereby challenging the sustainability of various interventions. Additionally, there is a need to better understand which research approach is most effective in promoting long-term behaviour compliance in global low- and middle-income settings. © 2011 Blackwell Publishing Ltd.

Premorbid personality characteristics and attachment style moderate the effect of injury severity on occupational outcome in traumatic brain injury: another aspect of reserve.

PubMed

Sela-Kaufman, Michal; Rassovsky, Yuri; Agranov, Eugenia; Levi, Yifat; Vakil, Eli

2013-01-01

The concept of "reserve" has been proposed to account for the mismatch between brain pathology and its clinical expression. Prior efforts to characterize this concept focused mostly on brain or cognitive reserve measures. The present study was a preliminary attempt to evaluate premorbid personality and emotional aspects as potential moderators in moderate-to-severe traumatic brain injury. Using structural equation modeling and multiple regression analyses, we found that premorbid personality characteristics provided the most robust moderator of injury severity on occupational outcome. Findings offer preliminary support for premorbid personality features as another relevant reserve construct in predicting outcome in this population.

Force-Sensing Enhanced Simulation Environment (ForSense) for laparoscopic surgery training and assessment.

PubMed

Cundy, Thomas P; Thangaraj, Evelyn; Rafii-Tari, Hedyeh; Payne, Christopher J; Azzie, Georges; Sodergren, Mikael H; Yang, Guang-Zhong; Darzi, Ara

2015-04-01

Excessive or inappropriate tissue interaction force during laparoscopic surgery is a recognized contributor to surgical error, especially for robotic surgery. Measurement of force at the tool-tissue interface is, therefore, a clinically relevant skill assessment variable that may improve effectiveness of surgical simulation. Popular box trainer simulators lack the necessary technology to measure force. The aim of this study was to develop a force sensing unit that may be integrated easily with existing box trainer simulators and to (1) validate multiple force variables as objective measurements of laparoscopic skill, and (2) determine concurrent validity of a revised scoring metric. A base plate unit sensitized to a force transducer was retrofitted to a box trainer. Participants of 3 different levels of operative experience performed 5 repetitions of a peg transfer and suture task. Multiple outcome variables of force were assessed as well as a revised scoring metric that incorporated a penalty for force error. Mean, maximum, and overall magnitudes of force were significantly different among the 3 levels of experience, as well as force error. Experts were found to exert the least force and fastest task completion times, and vice versa for novices. Overall magnitude of force was the variable most correlated with experience level and task completion time. The revised scoring metric had similar predictive strength for experience level compared with the standard scoring metric. Current box trainer simulators can be adapted for enhanced objective measurements of skill involving force sensing. These outcomes are significantly influenced by level of expertise and are relevant to operative safety in laparoscopic surgery. Conventional proficiency standards that focus predominantly on task completion time may be integrated with force-based outcomes to be more accurately reflective of skill quality. Copyright © 2015 Elsevier Inc. All rights reserved.

Patient autonomy in multiple sclerosis--possible goals and assessment strategies.

PubMed

Heesen, C; Köpke, S; Solari, A; Geiger, F; Kasper, J

2013-08-15

Patient autonomy has been increasingly acknowledged as prerequisite for successful medical decision making in Western countries. In medical decisions with a need to involve a health professional, patient autonomy becomes apparent in the extent of patients' participation in the communication as described in the concept of shared decision making. Patient autonomy can be derived from different perspectives or goals and the focus of evaluation approaches may vary accordingly. Multiple sclerosis (MS) is a paradigmatic disease to study patient autonomy mainly because MS patients are highly disease competent and due to ambiguous evidence on many aspects of disease-related medical decision making. This review gives an overview on measurement issues in studying decision making in MS, categorized according to prerequisites, process measures and outcomes of patient autonomy. As relevant prerequisites role preferences, risk attribution, risk tolerance, and risk knowledge are discussed. Regarding processes, we distinguish intra-psychic and interpersonal aspects. Intra-psychic processes are elucidated using the theory of planned behavior, which guided development of a 30-item scale to capture decisions about immunotherapy. Moreover, a theory of uncertainty management has been created resulting in the development of a corresponding measurement concept. Interpersonal processes evolving between physician and patient can be thoroughly analyzed from different perspectives by use of the newly developed comprehensive MAPPIN'SDM inventory. Concerning outcomes, besides health related outcomes, we discuss match of preferred roles during the decision encounters (preference match), decisional conflict as well as an application of the multidimensional measure of informed choice to decisions of MS patients. These approaches provide an overview on patient-inherent and interpersonal factors and processes modulating medical decision making and health behavior in MS and beyond. Copyright © 2013. Published by Elsevier B.V.

Testing covariates of Type 2 diabetes-cognition associations in older adults: moderating or mediating effects?

PubMed

McFall, G Peggy; Geall, Bonnie P; Fischer, Ashley L; Dolcos, Sanda; Dixon, Roger A

2010-09-01

The general goal of this study was to advance our understanding of Type 2 diabetes (T2D)-cognition relationships in older adults by linking and testing comprehensive sets of potential moderators, potential mediators, and multiple cognitive outcomes. We identified in the literature 13 health-related (but T2D-distal) potential covariates, representing four informal domains (i.e., biological vitality, personal affect, subjective health, lifestyle activities). Cross-sectional data from the Victoria Longitudinal Study (age range = 53-90 years; n = 41 T2D and n = 458 control participants) were used. We first examined whether any of the 13 potential covariates influenced T2D-cognition associations, as measured by a comprehensive neuropsychological battery (15 measures). Next, using standard regression-based moderator and mediator analyses, we systematically tested whether the identified covariates would significantly alter observed T2D-cognition relationships. Six potential covariates were found to be sensitive to T2D associations with performance on seven cognitive measures. Three factors (systolic blood pressure, gait-balance composite, subjective health) were significant mediators. Each mediated multiple cognitive outcomes, especially measures of neurocognitive speed, executive functioning, and episodic memory. Our findings offer a relatively comprehensive perspective of T2D-related cognitive deficits, comorbidities, and modulating influences. The implications for future research reach across several fields of study and application. These include (1) neuropsychological research on neural and biological bases of T2D-related cognitive decline, (2) clinical research on intervention and treatment strategies, and (3) larger-scale longitudinal studies examining the potential multilateral and dynamic relationships among T2D status, related comorbidities, and cognitive outcomes. Copyright 2010 APA, all rights reserved.

Epigenetic Variation in the Mu-opioid Receptor Gene in Infants with Neonatal Abstinence Syndrome

PubMed Central

Wachman, Elisha M; Hayes, Marie J; Lester, Barry M; Terrin, Norma; Brown, Mark S; Nielsen, David A; Davis, Jonathan M

2014-01-01

Objective Neonatal abstinence syndrome (NAS) from in utero opioid exposure is highly variable with genetic factors appearing to play an important role. Epigenetic changes in cytosine:guanine (CpG) dinucleotide methylation can occur after drug exposure and may help to explain NAS variability. We correlated DNA methylation levels in the mu-opioid receptor (OPRM1) promoter in opioid-exposed infants and correlate them with NAS outcomes. Study design DNA samples from cord blood or saliva were analyzed for 86 infants being treated for NAS according to institutional protocol. Methylation levels at 16 OPRM1 CpG sites were determined and correlated with NAS outcome measures, including need for treatment, treatment with >2 medications, and length of hospital stay. We adjusted for co-variates and multiple genetic testing. Results Sixty-five percent of infants required treatment for NAS, and 24% required ≥2 medications. Hypermethylation of the OPRM1 promoter was measured at the −10 CpG in treated versus non-treated infants [adjusted difference δ=3.2% (95% CI 0.3–6.0%), p=0.03; NS after multiple testing correction]. There was hypermethylation at the −14 [δ=4.9% (95% CI 1.8–8.1%), p=0.003], −10 [δ=5.0% (95% CI 2.3–7.7%), p=0.0005)], and +84 [δ=3.5% (95% CI 0.6 – 6.4), p=0.02] CpG sites in infants requiring ≥2 medications which remained significant for −14 and −10 after multiple testing correction. Conclusions Increased methylation within the OPRM1 promoter is associated with worse NAS outcomes, consistent with gene silencing. PMID:24996986

Short-lived climate pollutant mitigation and the Sustainable Development Goals

NASA Astrophysics Data System (ADS)

Haines, Andy; Amann, Markus; Borgford-Parnell, Nathan; Leonard, Sunday; Kuylenstierna, Johan; Shindell, Drew

2017-12-01

The post-2015 development agenda is dominated by a set of Sustainable Development Goals (SDGs) that arose from the 2012 Rio+20 United Nations Conference on Sustainable Development. The 17 goals and 169 targets address diverse and intersecting aspects of human and environmental needs and challenges. Achieving the SDGs by 2030 requires implementing coordinated and concerted strategies and actions that minimize potential trade-offs and conflicts and maximize synergies to contribute to multiple SDGs. Measures to mitigate emissions of short-lived climate pollutants are an example of actions that contribute to multiple outcomes relevant to development. This Perspective highlights the interlinkages between these pollutants and the SDGs, and shows that implementing emissions reduction measures can contribute to achieving many of the SDGs.

Breast surgery techniques: preoperative bracketing wire localization by surgeons.

PubMed

Burkholder, Hans C; Witherspoon, Laura E; Burns, R Phillip; Horn, Jeffrey S; Biderman, Michael D

2007-06-01

With the development of expertise in image guidance for breast surgery, many surgeons now perform preoperative wire localization themselves. Use of a single wire versus multiple wires to bracket a radiographic breast abnormality has previously been described, although benefits of this technique based on clinical outcomes such as margin status, tissue volume removed, and re-excision rates have not been established. This study is a retrospective analysis of wire-localized breast biopsies performed by 14 surgeons over 29 months; stereotactic and ultrasound guidance were used. During this time, 489 wire localizations were done, of which 159 used multiple wires. Two hundred eleven of these biopsies were done for malignant disease, 86 using multiple wires. After controlling for tumor node metastases stage, single and multiple wire placements were compared using endpoints of margin status, need for re-excision, and total volume of tissue removed. Neither margin status nor re-excision was related to the number of wires placed. However, the number of wires placed was significantly related to the total volume of tissue removed. Use of more than one localizing wire was associated with greater volume of tissue removal (measured in centimeters cubed) in benign disease (46 vs 25, P < 0.001), equivalent volumes in stage 0 disease (73 vs 67), less volume in stage 1 disease (113 vs 164), and less volume in stages 2 through 4 (158 vs 207, P = 0.03). Outcomes based on surgeon case volume during the study period demonstrated that low- (1-40), medium- (41-80), and high-volume (>80) surgeons did not differ in the type or stage of breast pathology treated. Surgeons with high case volumes were more likely to place multiple localizing wires (P < 0.001) and were more likely to do a breast-conserving procedure if re-excision was performed (P < 0.018). Surgeons with low case volumes were more likely to perform a re-excision (P < 0.025). Surgeon experience has a positive impact on quality outcome measures such as performance of a definitive procedure at the time of initial surgery and use of breast-conserving procedures at the time of re-excision. Multiple wire localization can be used to significantly reduce the volume of breast tissue removed in malignant disease without sacrificing margin status or increasing the need for future re-excision.

Relationship between postoperative refractive outcomes and cataract density: multiple regression analysis.

PubMed

Ueda, Tetsuo; Ikeda, Hitoe; Ota, Takeo; Matsuura, Toyoaki; Hara, Yoshiaki

2010-05-01

To evaluate the relationship between cataract density and the deviation from the predicted refraction. Department of Ophthalmology, Nara Medical University, Kashihara, Japan. Axial length (AL) was measured in eyes with mainly nuclear cataract using partial coherence interferometry (IOLMaster). The postoperative AL was measured in pseudophakic mode. The AL difference was calculated by subtracting the postoperative AL from the preoperative AL. Cataract density was measured with the pupil dilated using anterior segment Scheimpflug imaging (EAS-1000). The predicted postoperative refraction was calculated using the SRK/T formula. The subjective refraction 3 months postoperatively was also measured. The mean absolute prediction error (MAE) (mean of absolute difference between predicted postoperative refraction and spherical equivalent of postoperative subjective refraction) was calculated. The relationship between the MAE and cataract density, age, preoperative visual acuity, anterior chamber depth, corneal radius of curvature, and AL difference was evaluated using multiple regression analysis. In the 96 eyes evaluated, the MAE was correlated with cataract density (r = 0.37, P = .001) and the AL difference (r = 0.34, P = .003) but not with the other parameters. The AL difference was correlated with cataract density (r = 0.53, P<.0001). The postoperative refractive outcome was affected by cataract density. This should be taken into consideration in eyes with a higher density cataract. (c) 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

The influence of ankle dorsiflexion and self-reported patient outcomes on dynamic postural control in participants with chronic ankle instability.

PubMed

Terada, Masafumi; Harkey, Matthew S; Wells, Ashley M; Pietrosimone, Brian G; Gribble, Phillip A

2014-01-01

We investigated the influence of ankle dorsiflexion range of motion (DF-ROM) and self-reported patient outcomes on dynamic postural control assessed with the Star Excursion Balance Test (SEBT) in individuals with chronic ankle instability (CAI). Twenty-nine participants with self-reported CAI volunteered. The primary outcome measurements were categorized into clinician-and patient-generated. Clinician-generated outcome measurements included anterior (SEBT-A), posteriormedial (SEBT-PM) and posteriorlateral (SEBT-PL) reach distances (cm) normalized by leg length (cm) of the SEBT, maximum weight-bearing dorsiflexion (WB-DF) (cm), and open-chain DF-ROM (°). Self-reported patient-generated outcome measures included the foot and ankle ability measure and the level of perceived pain, stiffness, stability, and function of their involved ankle on a 10-cm visual analog scale (VAS). Pearson product moment correlations were used to examine the relationship of the SEBT performances with DF-ROM and self-reported patient outcome measures. A multiple linear regression was performed to determine the influence of patient- and clinician-generated measures on the SEBT. SEBT-A performance was significantly and fairly correlated with WB-DF (r=0.410, p=0.014), perceived ankle stiffness (r=0.477, p=0.014), and open-chain DF-ROM (r=0.404, p=0.015). The strongest predictor of the variance in SEBT-A was the combination of the variance in WB-DF and VAS-stiffness (R2=0.348, p=0.004). There were no significant correlations with the SEBT-PM and SEBT-PL. WB-DF and VAS-stiffness may represent targets for intervention that need to be addressed to produce the best outcome in participants with CAI when altered dynamic postural control is detected on the SEBT-A. Copyright © 2014 Elsevier B.V. All rights reserved.

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

PubMed Central

2012-01-01

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

Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis.

PubMed

Tedesco Triccas, L; Burridge, J H; Hughes, A M; Pickering, R M; Desikan, M; Rothwell, J C; Verheyden, G

2016-01-01

To systematically review the methodology in particular treatment options and outcomes and the effect of multiple sessions of transcranial direct current stimulation (tDCS) with rehabilitation programmes for upper extremity recovery post stroke. A search was conducted for randomised controlled trials involving tDCS and rehabilitation for the upper extremity in stroke. Quality of included studies was analysed using the Modified Downs and Black form. The extent of, and effect of variation in treatment parameters such as anodal, cathodal and bi-hemispheric tDCS on upper extremity outcome measures of impairment and activity were analysed using meta-analysis. Nine studies (371 participants with acute, sub-acute and chronic stroke) were included. Different methodologies of tDCS and upper extremity intervention, outcome measures and timing of assessments were identified. Real tDCS combined with rehabilitation had a small non-significant effect of +0.11 (p=0.44) and +0.24 (p=0.11) on upper extremity impairments and activities at post-intervention respectively. Various tDCS methods have been used in stroke rehabilitation. The evidence so far is not statistically significant, but is suggestive of, at best, a small beneficial effect on upper extremity impairment. Future research should focus on which patients and rehabilitation programmes are likely to respond to different tDCS regimes. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations of maternal A1C and glucose with pregnancy outcomes.

PubMed

Lowe, Lynn P; Metzger, Boyd E; Dyer, Alan R; Lowe, Julia; McCance, David R; Lappin, Terence R J; Trimble, Elisabeth R; Coustan, Donald R; Hadden, David R; Hod, Moshe; Oats, Jeremy J N; Persson, Bengt

2012-03-01

To compare associations of maternal glucose and A1C with adverse outcomes in the multinational Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study and determine, based on those comparisons, if A1C measurement can provide an alternative to an oral glucose tolerance test (OGTT) in pregnant women. Eligible pregnant women underwent a 75-g OGTT at 24-32 weeks' gestation. A sample for A1C was also collected. Neonatal anthropometrics and cord serum C-peptide were measured. Associations with outcomes were assessed using multiple logistic regression with adjustment for potential confounders. Among 23,316 HAPO Study participants with glucose levels blinded to caregivers, 21,064 had a nonvariant A1C result. The mean ± SD A1C was 4.79 ± 0.40%. Associations were significantly stronger with glucose measures than with A1C for birth weight, sum of skinfolds, and percent body fat >90th percentile and for fasting and 1-h glucose for cord C-peptide (all P < 0.01). For example, in fully adjusted models, odds ratios (ORs) for birth weight >90th percentile for each measure higher by 1 SD were 1.39, 1.45, and 1.38, respectively, for fasting, 1-, and 2-h plasma glucose and 1.15 for A1C. ORs for cord C-peptide >90th percentile were 1.56, 1.45, and 1.35 for glucose, respectively, and 1.32 for A1C. ORs were similar for glucose and A1C for primary cesarean section, preeclampsia, and preterm delivery. On the basis of associations with adverse outcomes, these findings suggest that A1C measurement is not a useful alternative to an OGTT in pregnant women.

Inequalities in multiple health outcomes by education, sex, and race in 93 US counties: Why we should measure them all

PubMed Central

2014-01-01

Introduction Regular reporting of health inequalities is essential to monitoring progress of efforts to reduce health inequalities. While reporting of population health became increasingly common, reporting of a subpopulation group breakdown of each indicator of the health of the population is rarely a standard practice. This study reports education-, sex-, and race-related inequalities in four health outcomes in each of the selected 93 counties in the United States in a systematic and comparable manner. Methods This study is a cross-sectional analysis of large, publicly available data, 2008, 2009, and 2010 Behavioral Risk Factor Surveillance System (BRFSS) Selected Metropolitan/Micropolitan Area Risk Trends (SMART) and 2008, 2009, and 2010 United States Birth Records from the National Vital Statistics System. The study population is American adults older than 25 years of age residing in the selected 93 counties, representing about 30% of the US population, roughly equally covering all geographic regions of the country. Main outcome measures are: (1) Attribute (group characteristic)-specific inequality: education-, sex-, or race-specific inequality in each of the four health outcomes (poor or fair health, poor physical health days, poor mental health days, and low birthweight) in each county; (2) Overall inequality: the average of these three attribute-specific inequalities for each health outcome in each county; and (3) Summary inequality in total morbidity: the weighted average of the overall inequalities across the four health outcomes in each county. Results The range of inequality across the counties differed considerably by health outcome; inequality in poor or fair health had the widest range and the highest median among inequalities in all health outcomes. In more than 70% of the counties, education-specific inequality was the largest in all health outcomes except for low birthweight. Conclusions It is feasible to extend population health reporting to include reporting of a subpopulation group breakdown of each indicator of the health of the population at a small jurisdictional level using publicly available data. No single group characteristic or health outcome represents the whole picture of health inequalities in a population. Examining multiple group characteristics and outcomes in a comparable manner is essential in reporting health inequalities. PMID:24927805

Measuring Near-Infrared Spectroscopy Derived Cerebral Autoregulation in Neonates: From Research Tool Toward Bedside Multimodal Monitoring

PubMed Central

Thewissen, Liesbeth; Caicedo, Alexander; Lemmers, Petra; Van Bel, Frank; Van Huffel, Sabine; Naulaers, Gunnar

2018-01-01

Introduction: Cerebral autoregulation (CAR), the ability of the human body to maintain cerebral blood flow (CBF) in a wide range of perfusion pressures, can be calculated by describing the relation between arterial blood pressure (ABP) and cerebral oxygen saturation measured by near-infrared spectroscopy (NIRS). In literature, disturbed CAR is described in different patient groups, using multiple measurement techniques and mathematical models. Furthermore, it is unclear to what extent cerebral pathology and outcome can be explained by impaired CAR. Aim and methods: In order to summarize CAR studies using NIRS in neonates, a systematic review was performed in the PUBMED and EMBASE database. To provide a general overview of the clinical framework used to study CAR, the different preprocessing methods and mathematical models are described and explained. Furthermore, patient characteristics, definition of impaired CAR and the outcome according to this definition is described organized for the different patient groups. Results: Forty-six articles were included in this review. Four patient groups were established: preterm infants during the transitional period, neonates receiving specific medication/treatment, neonates with congenital heart disease and neonates with hypoxic-ischemic encephalopathy (HIE) treated with therapeutic hypothermia. Correlation, coherence and transfer function (TF) gain are the mathematical models most frequently used to describe CAR. The definition of impaired CAR is depending on the mathematical model used. The incidence of intraventricular hemorrhage in preterm infants is the outcome variable most frequently correlated with impaired CAR. Hypotension, disease severity, dopamine treatment, injury on magnetic resonance imaging (MRI) and long term outcome are associated with impaired CAR. Prospective interventional studies are lacking in all research areas. Discussion and conclusion: NIRS derived CAR measurement is an important research tool to improve knowledge about central hemodynamic fluctuations during the transitional period, cerebral pharmacodynamics of frequently used medication (sedatives-inotropes) and cerebral effects of specific therapies in neonatology. Uniformity regarding measurement techniques and mathematical models is needed. Multimodal monitoring databases of neonatal intensive care patients of multiple centers, together with identical outcome parameters are needed to compare different techniques and make progress in this field. Real-time bedside monitoring of CAR, together with conventional monitoring, seems a promising technique to improve individual patient care. PMID:29868521

Defining Multiple Chronic Conditions for Quality Measurement.

PubMed

Drye, Elizabeth E; Altaf, Faseeha K; Lipska, Kasia J; Spatz, Erica S; Montague, Julia A; Bao, Haikun; Parzynski, Craig S; Ross, Joseph S; Bernheim, Susannah M; Krumholz, Harlan M; Lin, Zhenqiu

2018-02-01

Patients with multiple chronic conditions (MCCs) are a critical but undefined group for quality measurement. We present a generally applicable systematic approach to defining an MCC cohort of Medicare fee-for-service beneficiaries that we developed for a national quality measure, risk-standardized rates of unplanned admissions for Accountable Care Organizations. To define the MCC cohort we: (1) identified potential chronic conditions; (2) set criteria for cohort conditions based on MCC framework and measure concept; (3) applied the criteria informed by empirical analysis, experts, and the public; (4) described "broader" and "narrower" cohorts; and (5) selected final cohort with stakeholder input. Subjects were patients with chronic conditions. Participants included 21.8 million Medicare fee-for-service beneficiaries in 2012 aged 65 years and above with ≥1 of 27 Medicare Chronic Condition Warehouse condition(s). In total, 10 chronic conditions were identified based on our criteria; 8 of these 10 were associated with notably increased admission risk when co-occurring. A broader cohort (2+ of the 8 conditions) included 4.9 million beneficiaries (23% of total cohort) with an admission rate of 70 per 100 person-years. It captured 53% of total admissions. The narrower cohort (3+ conditions) had 2.2 million beneficiaries (10%) with 100 admissions per 100 person-years and captured 32% of admissions. Most stakeholders viewed the broader cohort as best aligned with the measure concept. By systematically narrowing chronic conditions to those most relevant to the outcome and incorporating stakeholder input, we defined an MCC admission measure cohort supported by stakeholders. This approach can be used as a model for other MCC outcome measures.

Efficacy of physical therapy in multiple sclerosis as measured with the modified fatigue impact scale and ambulation index: a retrospective study.

PubMed

Brichetto, Giampaolo; Rinaldi, Sara; Spallarossa, Patricio; Battaglia, Mario Alberto; de Carvalho, Maria Laura Lopes

2013-01-01

Evaluate the efficacy of outcome measures routinely used in a physical therapy service for Multiple Sclerosis (MS). We performed a retrospective review of 500 medical records of MS patients from the outpatients service of AISM Rehabilitation Centre, Genova, Italy. All records of outpatients followed by AISM Rehabilitation Centre who underwent physical therapy from 2006 to 2008 were evaluated. Modified Fatigue Impact Scale (MFIS) and Ambulation Index (AI) were reviewed for all records at the begin and at the end of the rehabilitation treatment. The number of assessments recorded was 295 in 209 patients. Out of the 209 patients, 133 were female and 76 were male. The mean age was 51.6 ± 11.68 years, the mean Expanded Disability Status Scale (EDSS) score was 4.98 ± 1.79, and 185 patients were ambulatory. In nonambulatory patients neither scale showed a significant increase. In ambulatory patients (275 assessments) significant changes were observed in AI, MFIS total score and subscores. Physical therapy has a positive impact on fatigue, and the MFIS seems to be a good outcome measure in ambulatory patients. The AI and MFIS seem to be not indicated for use in non-ambulatory patients.

Frailty and resilience in an older population. The role of resilience during rehabilitation after orthopedic surgery in geriatric patients with multiple comorbidities.

PubMed

Rebagliati, G A A; Sciumè, L; Iannello, P; Mottini, A; Antonietti, A; Caserta, V A; Gattoronchieri, V; Panella, Lorenzo; Callegari, Camilla

2016-01-01

Hip fracture is common in the elderly and it is usually associated with comorbidities and physiological changes which may have an impact on functioning and quality of life. The concept of resilience may explain why this impact varies among patients. The aim of this open, prospective cohort study was to explore the relationships between resilience, frailty and quality of life in orthopedic rehabilitation patients, and also to assess whether these factors might affect rehabilitation outcome. Eighty-one patients, older than 60 years, underwent a multidisciplinary assessment at the beginning and at the end of the rehabilitation period following orthopedic surgery to the lower limb. The assessments were performed using the Resilience Scale, the Multidimensional Prognostic Index (as a measure of frailty), the WHO Quality of Life-BRIEF, the Geriatric Depression Scale, and the Functional Independence Frailty and resilience in an older population. The role of resilience during rehabilitation after orthopedic surgery in geriatric patients with multiple comorbidities Measure (as a measure of the rehabilitation outcome). A negative correlation between disability and resilience emerged and this association interacted with frailty level. We also found that resilience and quality of life are positive predictors of functional status at discharge.

Age and Socioeconomic Gradients of Health of Indian Adults: An Assessment of Self-Reported and Biological Measures of Health.

PubMed

Arokiasamy, Perianayagam; Uttamacharya; Kowal, Paul; Chatterji, Somnath

2016-06-01

This paper describes overall socioeconomic gradients and the age patterns of socioeconomic gradients of health of Indian adults for multiple health indicators encompassing the multiple aspects of health. Cross-sectional data on 11,230 Indians aged 18 years and older from the WHO-SAGE India Wave 1, 2007 were analyzed. Multivariate logit models were estimated to examine effects of socioeconomic status (education and household wealth) and age on four health domains: self-rated health, self-reported functioning, chronic diseases, and biological health measures. Results show that socioeconomic status (SES) was negatively associated with prevalence of each health measure but with considerable heterogeneity across age groups. Results for hypertension and COPD were inconclusive. SES effects are significant while adjusting for background characteristics and health risk factors. The age patterns of SES gradient of health depict divergence with age, however, no conclusive age pattern emerged for biological markers. Overall, results in this paper dispelled the conclusion of negative SES-health association found in some previous Indian studies and reinforced the hypothesis of positive association of SES with health for Indian adults. Higher prevalence of negative health outcomes and SES disparities of health outcomes among older age-groups highlight need for inclusive and focused health care interventions for older adults across socioeconomic spectrum.

Nervous System Sensitization as a Predictor of Outcome in the Treatment of Peripheral Musculoskeletal Conditions: A Systematic Review.

PubMed

O'Leary, Helen; Smart, Keith M; Moloney, Niamh A; Doody, Catherine M

2017-02-01

Research suggests that peripheral and central nervous system sensitization can contribute to the overall pain experience in peripheral musculoskeletal (MSK) conditions. It is unclear, however, whether sensitization of the nervous system results in poorer outcomes following the treatment. This systematic review investigated whether nervous system sensitization in peripheral MSK conditions predicts poorer clinical outcomes in response to a surgical or conservative intervention. Four electronic databases were searched to identify the relevant studies. Eligible studies had a prospective design, with a follow-up assessing the outcome in terms of pain or disability. Studies that used baseline indices of nervous system sensitization were included, such as quantitative sensory testing (QST) or questionnaires that measured centrally mediated symptoms. Thirteen studies met the inclusion criteria, of which six were at a high risk of bias. The peripheral MSK conditions investigated were knee and hip osteoarthritis, shoulder pain, and elbow tendinopathy. QST parameters indicative of sensitization (lower electrical pain thresholds, cold hyperalgesia, enhanced temporal summation, lower punctate sharpness thresholds) were associated with negative outcome (more pain or disability) in 5 small exploratory studies. Larger studies that accounted for multiple confounders in design and analysis did not support a predictive relationship between QST parameters and outcome. Two studies used self-report measures to capture comorbid centrally mediated symptoms, and found higher questionnaire scores were independently predictive of more persistent pain following a total joint arthroplasty. This systematic review found insufficient evidence to support an independent predictive relationship between QST measures of nervous system sensitization and treatment outcome. Self-report measures demonstrated better predictive ability. Further high-quality prognostic research is warranted. © 2016 World Institute of Pain.

Cashing In or Cashing Out: Tools for Measuring the Effectiveness & Outcomes of Financial Aid Events

ERIC Educational Resources Information Center

Kennedy, Brianna; Oliverez, Paz M.; Tierney, William G.

2007-01-01

Financial aid-related information and services are provided to students and families in a variety of ways. The timing of when information is shared with these groups also varies. Financial aid information is typically provided through events sponsored by high schools, colleges and universities, and multiple community and government-sponsored…

Response to "Redesigning Systems of School Accountability": Addressing Underlying Inequities

ERIC Educational Resources Information Center

Gil, Elizabeth; Kim, Taeyon

2018-01-01

As Bae (2018) suggests, one way to fill gaps between a holistic view of student learning and accountability policy implementation is to use multiple measures that reflect diverse perspectives of learning. The purpose of this commentary is to provide a discussion of issues, which need to be considered in order to achieve the desired outcomes of…

Services Received and Parental Perception of Quality of Life for Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Cholewicki, Judith Marie

2015-01-01

With the rapid increase in the rate of children diagnosed with Autism Spectrum Disorder (ASD), there has been a surge in treatment interventions and outcome measures. Treatment interventions consist of evidence-based practices and programs that lack scientific validation. Parents' selection of a treatment or multiple treatments is often based on…

Behavioral Relaxation Training for Parkinson's Disease Related Dyskinesia and Comorbid Social Anxiety

ERIC Educational Resources Information Center

Lundervold, Duane A.; Pahwa, Rajesh; Lyons, Kelly E.

2013-01-01

Effects of brief Behavioral Relaxation Training (BRT) on anxiety and dyskinesia of a 57-year-old female, with an 11-year history of Parkinson's disease (PD) and 18-months post-deep brain stimulation of the subthalamic nucleus, were evaluated. Multiple process and outcome measures were used including the Clinical Anxiety Scale (CAS), Subjective…

The quality of systematic reviews of health-related outcome measurement instruments.

PubMed

Terwee, C B; Prinsen, C A C; Ricci Garotti, M G; Suman, A; de Vet, H C W; Mokkink, L B

2016-04-01

Systematic reviews of outcome measurement instruments are important tools for the selection of instruments for research and clinical practice. Our aim was to assess the quality of systematic reviews of health-related outcome measurement instruments and to determine whether the quality has improved since our previous study in 2007. A systematic literature search was performed in MEDLINE and EMBASE between July 1, 2013, and June 19, 2014. The quality of the reviews was rated using a study-specific checklist. A total of 102 reviews were included. In many reviews the search strategy was considered not comprehensive; in only 59 % of the reviews a search was performed in EMBASE and in about half of the reviews there was doubt about the comprehensiveness of the search terms used for type of measurement instruments and measurement properties. In 41 % of the reviews, compared to 30 % in our previous study, the methodological quality of the included studies was assessed. In 58 %, compared to 55 %, the quality of the included instruments was assessed. In 42 %, compared to 7 %, a data synthesis was performed in which the results from multiple studies on the same instrument were somehow combined. Despite a clear improvement in the quality of systematic reviews of outcome measurement instruments in comparison with our previous study in 2007, there is still room for improvement with regard to the search strategy, and especially the quality assessment of the included studies and the included instruments, and the data synthesis.

Predictors of delay in heart failure patients and consequences for outcomes.

PubMed

Sethares, Kristen A; Chin, Elizabeth; Jurgens, Corrine Y

2015-02-01

Persons with heart failure (HF) symptoms delay up to 7 days before seeking treatment. Delay can result in worse symptoms and potentially impact outcomes. The purpose of this review was to describe predictors and outcomes of delay in HF patients. Demographic factors, increased symptom number, social factors, greater HF knowledge, lower anxiety, and depression predicted increased delay. HF patients had difficulty recognizing and interpreting symptoms of HF. Results are conflicting related to symptom pattern, time of care seeking, and history of HF as predictors of delay. The only outcome predicted by delay was length of stay with those delaying longer reporting longer lengths of stay. Future research related to delay should include theoretical frameworks and larger, more ethnically diverse samples from multiple sites and link delay to outcomes. Valid and reliable instruments are needed to measure delay and related factors. HF education should include supportive others.

Validity of the Instrumented Push and Release Test to Quantify Postural Responses in Persons With Multiple Sclerosis.

PubMed

El-Gohary, Mahmoud; Peterson, Daniel; Gera, Geetanjali; Horak, Fay B; Huisinga, Jessie M

2017-07-01

To test the validity of wearable inertial sensors to provide objective measures of postural stepping responses to the push and release clinical test in people with multiple sclerosis. Cross-sectional study. University medical center balance disorder laboratory. Total sample N=73; persons with multiple sclerosis (PwMS) n=52; healthy controls n=21. Stepping latency, time and number of steps required to reach stability, and initial step length were calculated using 3 inertial measurement units placed on participants' lumbar spine and feet. Correlations between inertial sensor measures and measures obtained from the laboratory-based systems were moderate to strong and statistically significant for all variables: time to release (r=.992), latency (r=.655), time to stability (r=.847), time of first heel strike (r=.665), number of steps (r=.825), and first step length (r=.592). Compared with healthy controls, PwMS demonstrated a longer time to stability and required a larger number of steps to reach stability. The instrumented push and release test is a valid measure of postural responses in PwMS and could be used as a clinical outcome measures for patient care decisions or for clinical trials aimed at improving postural control in PwMS. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The role of robotic gait training coupled with virtual reality in boosting the rehabilitative outcomes in patients with multiple sclerosis.

PubMed

Russo, Margherita; Dattola, Vincenzo; De Cola, Maria C; Logiudice, Anna L; Porcari, Bruno; Cannavò, Antonino; Sciarrone, Francesca; De Luca, Rosaria; Molonia, Francesco; Sessa, Edoardo; Bramanti, Placido; Calabrò, Rocco S

2018-06-01

Motor impairment is the most common symptom in multiple sclerosis (MS). Thus, a variety of new rehabilitative strategies, including robotic gait training, have been implemented, showing their effectiveness. The aim of our study was to investigate whether an intensive robotic gait training, preceding a traditional rehabilitative treatment, could be useful in improving and potentiating motor performance in MS patients. Forty-five patients, who fulfilled the inclusion criteria, were enrolled in this study and randomized into either the control group (CG) or the experimental group (EG). A complete clinical evaluation, including the Expanded Disability Severity Scale, the Functional Independence Measure, the Hamilton Rating Scale for Depression, the time up and go test (TUG), and the Tinetti balance scale, was performed at baseline (T0), after 6 week (T1), at the end of rehabilitative training (T2), and 1 month later (T3). A significant improvement was observed in the EG for all the outcome measures, whereas the CG showed an improvement only in TUG. In contrast, from T1 to T2, only CG significantly improved in all outcomes, whereas the EG had an improvement only regarding TUG. From T2 to T3, no significant differences in Functional Independence Measure scores emerged for both the groups, but a significant worsening in Tinetti balance scale and TUG was observed for the CG and in TUG for the EG. Our study provides evidence that robotic rehabilitationn coupled with two-dimensional virtual reality may be a valuable tool in promoting functional recovery in patients with MS.

Effects of a Home-Based Upper Limb Training Program in Patients With Multiple Sclerosis: A Randomized Controlled Trial.

PubMed

Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Rodríguez-Torres, Janet; Fajardo-Contreras, Waldo; Díaz-Pelegrina, Ana; Valenza, Marie Carmen

2016-12-01

To evaluate the effects of a home-based upper limb training program on arm function in patients with multiple sclerosis (MS). Additionally, the effects of this program on manual dexterity, handgrip strength, and finger prehension force were analyzed. Randomized, single-blind controlled trial. Home based. Patients with a clinical diagnosis of MS acknowledging impaired manual ability (N=37) were randomized into 2 groups. Patients in the experimental group were included in a supervised home-based upper limb training program for 8 weeks twice a week. Patients in the control group received information in the form of a leaflet with a schedule of upper limb exercise training. The primary outcome measure was arm function (motor functioning assessed using the finger tapping test and a functional measure, the Action Research Arm Test). The secondary outcome measures were manual dexterity assessed with the Purdue Pegboard Test and handgrip strength and finger prehension force evaluated with a handgrip and a pinch dynamometer, respectively. After 8 weeks, a significant between-group improvement (P<.05) was found on the Action Research Arm Test bilaterally and the finger tapping test in the most affected upper limb. The secondary outcomes also improved in the most affected limb in the experimental group. An 8-week home-based intervention program focused on upper limbs twice a week improved arm function and physiologic variables with a primary focus on the more affected extremity in patients with MS compared with the control group. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Discordances originated by multiple meta-analyses on interventions for myocardial infarction: a systematic review.

PubMed

Lucenteforte, Ersilia; Moja, Lorenzo; Pecoraro, Valentina; Conti, Andrea A; Conti, Antonio; Crudeli, Elena; Galli, Alessio; Gensini, Gian Franco; Minnelli, Martina; Mugelli, Alessandro; Proietti, Riccardo; Shtylla, Jonida; D'Amico, Roberto; Parmelli, Elena; Virgili, Gianni

2015-03-01

To clarify the impact of multiple (covering the same population, intervention, control, and outcomes) systematic reviews (SRs) on interventions for myocardial infarction (MI). Clinical Evidence (BMJ Group) sections and related search strategies regarding MI were used to identify multiple SRs published between 1997 and 2007. Multiple SRs were classified as discordant if they featured conflicting results or interpretation of them. Thirty-six SRs (23.5% of 153 on the treatment or prevention of MI) were classified as multiple and grouped in 16 clusters [ie, at least two SRs with the same PICO (population, condition/disease, intervention, control) and at least one common outcome] exploring angioplasty, angiotensin-converting enzyme inhibitors, anticoagulants, antiplatelets, β-blockers, and stents. Complete agreement on statistically significant differences between interventions was found in 7 of 10 clusters with a shared composite outcome. Agreement was reduced when single outcomes were considered. Despite substantial variation and limited agreement in reporting of major outcomes, SRs agreed in their conclusions on the superiority of either the intervention or control in 14 of 16 clusters. Sources of minor discrepancies were found in terms of study and outcome selection, subgroup analyses, and interpretation of findings. Multiple SRs agreed in their qualitative conclusions but not on reporting and on analyses of hard outcomes. Discordance on significance of treatment effects was due to a combination of variation in design with inclusion of different studies and lack of precision for single hard outcomes compared with a composite outcome. Such inconsistencies among SRs could potentially slow the translation of SRs' results to clinical and public health decision making and suggest the need for a broader methodological and clinical agreement on their design. Copyright © 2015 Elsevier Inc. All rights reserved.

Modification of Multiple Sclerosis Phenotypes by African Ancestry at HLA

PubMed Central

Cree, Bruce A. C.; Reich, David E.; Khan, Omar; De Jager, Philip L.; Nakashima, Ichiro; Takahashi, Toshiyuki; Bar-Or, Amit; Tong, Christine; Hauser, Stephen L.; Oksenberg, Jorge R.

2015-01-01

Background In those with multiple sclerosis (MS), African American individuals have a more severe disease course, an older age at onset, and more often have clinical manifestations restricted to the optic nerves and spinal cord (opticospinal MS) than white persons. Objective To determine whether genetic variation influences clinical MS patterns. Design Retrospective multicenter cohort study. Participants Six hundred seventy-three African American and 717 white patients with MS. Main Outcome Measures Patients with MS were geno-typed for HLA-DRB1 and HLA-DQB1 alleles. The proportion of European ancestry at HLA was estimated by genotyping single-nucleotide polymorphisms with known significant frequency differences in West African and European populations. These genotypes were correlated with the opticospinal disease phenotype, disability measures, and age at onset. Results Subjects with DRB1*15 alleles were twice as likely to have typical MS rather than opticospinal MS (P = .001). Of the subjects with opticospinal MS or a history of recurrent transverse myelitis who were seropositive for anti–aquaporin 4 antibodies (approximately 5%), none carried DRB1*15 alleles (P = .008). Independently of DRB1* 15, African ancestry at HLA correlated with disability as measured by the Multiple Sclerosis Severity Score (P < .001) andriskof cane dependency (hazard ratio, 1.36; P < .001); DRB1*15 alleles were associated with a 2.1-year earlier age at onset (P < .001). Conclusions These data indicate that the role of HLA in MS is not limited to disease susceptibility but that genes embedded in this locus also influence clinical outcomes. PMID:19204159

A therapeutic skating intervention for children with autism spectrum disorder.

PubMed

Casey, Amanda Faith; Quenneville-Himbeault, Gabriel; Normore, Alexa; Davis, Hanna; Martell, Stephen G

2015-01-01

The purpose of this study was to evaluate the effects of a highly structured therapeutic skating intervention on motor outcomes and functional capacity in 2 boys with autism spectrum disorder aged 7 and 10 years. This multiple-baseline, single-subject study assigned participants to three 1-hour skating sessions per week for 12 weeks focusing on skill and motor development. Multiple data points assessed (a) fidelity to the intervention and (b) outcomes measures including the Pediatric Balance Scale, Timed Up and Go, floor to stand, Six-Minute Walk Test, goal attainment, and weekly on-ice testing. Improvements were found in balance, motor behavior, and functional capacity by posttest with gains remaining above pretest levels at follow-up. Therapeutic skating may produce physical benefits for children with autism spectrum disorder and offer a viable, inexpensive community-based alternative to other forms of physical activity.

Size and consistency of problem-solving consultation outcomes: an empirical analysis.

PubMed

Hurwitz, Jason T; Kratochwill, Thomas R; Serlin, Ronald C

2015-04-01

In this study, we analyzed extant data to evaluate the variability and magnitude of students' behavior change outcomes (academic, social, and behavioral) produced by consultants through problem-solving consultation with teachers. Research questions were twofold: (a) Do consultants produce consistent and sizeable positive student outcomes across their cases as measured through direct and frequent assessment? and (b) What proportion of variability in student outcomes is attributable to consultants? Analyses of extant data collected from problem-solving consultation outcome studies that used single-case, time-series AB designs with multiple participants were analyzed. Four such studies ultimately met the inclusion criteria for the extant data, comprising 124 consultants who worked with 302 school teachers regarding 453 individual students. Consultants constituted the independent variable, while the primary dependent variable was a descriptive effect size based on student behavior change as measured by (a) curriculum-based measures, (b) permanent products, or (c) direct observations. Primary analyses involved visual and statistical evaluation of effect size magnitude and variability observed within and between consultants and studies. Given the nested nature of the data, multilevel analyses were used to assess consultant effects on student outcomes. Results suggest that consultants consistently produced positive effect sizes on average across their cases, but outcomes varied between consultants. Findings also indicated that consultants, teachers, and the corresponding studies accounted for a significant proportion of variability in student outcomes. This investigation advances the use of multilevel and integrative data analyses to evaluate consultation outcomes and extends research on problem-solving consultation, consultant effects, and meta-analysis of case study AB designs. Practical implications for evaluating consultation service delivery in school settings are also discussed. Copyright © 2015 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

The influence of individual, group, and relative self-esteem on outcome for patients undergoing group cognitive-behavioural therapy treatment.

PubMed

Parker, Thomas J; Page, Andrew C; Hooke, Geoff R

2013-11-01

Despite a strong association between individual self-esteem and treatment outcome in group cognitive-behavioural therapy (GCBT), no study has investigated how patient outcomes might be influenced by an individual's self-esteem relative to other group members. The study comprised a retrospective examination of patients' data and used a multiple regression analysis to identify predictors of treatment outcome. Patients' pre-treatment self-esteem scores were assessed on a continuum and assigned to be low, medium, or high. Therapy groups were assigned to be either low, balanced or high self-esteem groups based on averaged self-esteem scores of participants. In this study, 3,878 patients who had completed a 10-day intensive cognitive behavioural group therapy programme at a private psychiatric facility were included in the study. The Rosenberg Self-Esteem measure was chosen to assess self-esteem. The three subscales of the Depression Anxiety Stress Scales were used as the outcome measures. Patient outcomes were influenced by pre-treatment self-esteem scores, such that higher initial self-esteem was associated with better treatment outcomes. Low group self-esteem was predictive of significantly better outcomes for depression, relative to higher self-esteem groups. Additionally, the combined influence of high individual self-esteem and low group self-esteem was associated with significantly enhanced depression improvement. High self-esteem patients perform better on outcome measures following completion of GCBT. Low self-esteem groups show greater improvement in depression symptoms. Similar results for depression are achieved when patients with high self-esteem complete treatment in low self-esteem groups. © 2013 The British Psychological Society.

Multiple sclerosis rehabilitation outcomes: analysis of a national casemix data set from Australia.

PubMed

Khan, F; Turner-Stokes, L; Stevermuer, T; Simmonds, F

2009-07-01

To examine the outcomes of inpatient rehabilitation for persons with multiple sclerosis (pwMS), using the Australian Rehabilitation Outcomes Centre (AROC) database. Deidentified data from the AROC database were analyzed for all rehabilitation admissions during 2003-2007, using four classes for functional level. The outcomes included Functional Independence Measure (FIM) scores and efficiency, hospital length of stay (LOS), and discharge destination. Of 1010 case episodes, 70% were women, admitted from home (n = 851) and discharged into the community (n = 890), and 97% (n = 986) were in the higher three classes for functional level (classes 216, 217, and 218). Majority of the more disabled pwMS were treated in the public hospital system, with a longer LOS compared with private facilities (P < 0.001). The FIM for classes 216-218 showed significant functional improvement during the admission (P < 0.001), and those in higher classes showed less change (likely due to higher FIM admission scores). FIM efficiency was significantly higher in class 217 than other classes (P < 0.001). The year-on-year trend was toward reducing hospital LOS and FIM efficiency, but these did not reach significance (P = 0.107, P = 0.634). The AROC data set is useful for describing rehabilitation outcomes for pwMS. However, additional information needs to be collected to evaluate nature of services provided and service implications.

Dynamic Latent Trait Models with Mixed Hidden Markov Structure for Mixed Longitudinal Outcomes.

PubMed

Zhang, Yue; Berhane, Kiros

2016-01-01

We propose a general Bayesian joint modeling approach to model mixed longitudinal outcomes from the exponential family for taking into account any differential misclassification that may exist among categorical outcomes. Under this framework, outcomes observed without measurement error are related to latent trait variables through generalized linear mixed effect models. The misclassified outcomes are related to the latent class variables, which represent unobserved real states, using mixed hidden Markov models (MHMM). In addition to enabling the estimation of parameters in prevalence, transition and misclassification probabilities, MHMMs capture cluster level heterogeneity. A transition modeling structure allows the latent trait and latent class variables to depend on observed predictors at the same time period and also on latent trait and latent class variables at previous time periods for each individual. Simulation studies are conducted to make comparisons with traditional models in order to illustrate the gains from the proposed approach. The new approach is applied to data from the Southern California Children Health Study (CHS) to jointly model questionnaire based asthma state and multiple lung function measurements in order to gain better insight about the underlying biological mechanism that governs the inter-relationship between asthma state and lung function development.

Investing in a Surgical Outcomes Auditing System

PubMed Central

Bermudez, Luis; Trost, Kristen; Ayala, Ruben

2013-01-01

Background. Humanitarian surgical organizations consider both quantity of patients receiving care and quality of the care provided as a measure of success. However, organizational efficacy is often judged by the percent of resources spent towards direct intervention/surgery, which may discourage investment in an outcomes monitoring system. Operation Smile's established Global Standards of Care mandate minimum patient followup and quality of care. Purpose. To determine whether investment of resources in an outcomes monitoring system is necessary and effectively measures success. Methods. This paper analyzes the quantity and completeness of data collected over the past four years and compares it against changes in personnel and resources assigned to the program. Operation Smile began investing in multiple resources to obtain the missing data necessary to potentially implement a global Surgical Outcomes Auditing System. Existing personnel resources were restructured to focus on postoperative program implementation, data acquisition and compilation, and training materials used to educate local foundation and international employees. Results. An increase in the number of postoperative forms and amount of data being submitted to headquarters occurred. Conclusions. Humanitarian surgical organizations would benefit from investment in a surgical outcomes monitoring system in order to demonstrate success and to ameliorate quality of care. PMID:23401763

Effect of exercise training on walking mobility in multiple sclerosis: a meta-analysis.

PubMed

Snook, Erin M; Motl, Robert W

2009-02-01

The study used meta-analytic procedures to examine the overall effect of exercise training interventions on walking mobility among individuals with multiple sclerosis. A search was conducted for published exercise training studies from 1960 to November 2007 using MEDLINE, PsychINFO, CINAHL, and Current Contents Plus. Studies were selected if they measured walking mobility, using instruments identified as acceptable walking mobility constructs and outcome measures for individuals with neurologic disorders, before and after an intervention that included exercise training. Forty-two published articles were located and reviewed, and 22 provided enough data to compute effect sizes expressed as Cohen's d. Sixty-six effect sizes were retrieved from the 22 publications with 600 multiple sclerosis participants and yielded a weighted mean effect size of g = 0.19 (95% confidence interval, 0.09-0.28). There were larger effects associated with supervised exercise training ( g = 0.32), exercise programs that were less than 3 months in duration (g = 0.28), and mixed samples of relapsing-remitting and progressive multiple sclerosis (g = 0.52). The cumulative evidence supports that exercise training is associated with a small improvement in walking mobility among individuals with multiple sclerosis.

Measuring Geographic Inequalities: Dealing with Multiple Health Resources by Data Envelopment Analysis

PubMed Central

Dlouhý, Martin

2018-01-01

The existence of geographic differences in health resources, health expenditures, the utilization of health services, and health outcomes have been documented by a lot of studies from various countries of the world. In a publicly financed health system, equal access is one of the main objectives of the national health policy. That is why inequalities in the geographic allocation of health resources are an important health policy issue. Measures of inequality express the complexity of variation in the observed variable by a single number, and there is a variety of inequality measures available. The objective of this study is to develop a measure of the geographic inequality in the case of multiple health resources. The measure uses data envelopment analysis (DEA), which is a non-parametric method of production function estimation, to transform multiple resources into a single virtual health resource. The study shows that the DEA originally developed for measuring efficiency can be used successfully to measure inequality. For the illustrative purpose, the inequality measure is calculated for the Czech Republic. The values of separate Robin Hood Indexes (RHIs) are 6.64% for physicians and 3.96% for nurses. In the next step, we use combined RHI for both health resources. Its value 5.06% takes into account that the combinations of two health resources serve regional populations. PMID:29541631

Voxelwise multivariate analysis of multimodality magnetic resonance imaging

PubMed Central

Naylor, Melissa G.; Cardenas, Valerie A.; Tosun, Duygu; Schuff, Norbert; Weiner, Michael; Schwartzman, Armin

2015-01-01

Most brain magnetic resonance imaging (MRI) studies concentrate on a single MRI contrast or modality, frequently structural MRI. By performing an integrated analysis of several modalities, such as structural, perfusion-weighted, and diffusion-weighted MRI, new insights may be attained to better understand the underlying processes of brain diseases. We compare two voxelwise approaches: (1) fitting multiple univariate models, one for each outcome and then adjusting for multiple comparisons among the outcomes and (2) fitting a multivariate model. In both cases, adjustment for multiple comparisons is performed over all voxels jointly to account for the search over the brain. The multivariate model is able to account for the multiple comparisons over outcomes without assuming independence because the covariance structure between modalities is estimated. Simulations show that the multivariate approach is more powerful when the outcomes are correlated and, even when the outcomes are independent, the multivariate approach is just as powerful or more powerful when at least two outcomes are dependent on predictors in the model. However, multiple univariate regressions with Bonferroni correction remains a desirable alternative in some circumstances. To illustrate the power of each approach, we analyze a case control study of Alzheimer's disease, in which data from three MRI modalities are available. PMID:23408378

Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy.

PubMed

Kalsi-Ryan, Sukhvinder; Singh, Anoushka; Massicotte, Eric M; Arnold, Paul M; Brodke, Darrel S; Norvell, Daniel C; Hermsmeyer, Jeffrey T; Fehlings, Michael G

2013-10-15

Narrative review. To identify suitable outcome measures that can be used to quantify neurological and functional impairment in the management of cervical spondylotic myelopathy (CSM). CSM is the leading cause of acquired spinal cord disability, causing varying degrees of neurological impairment which impact on independence and quality of life. Because this impairment can have a heterogeneous presentation, a single outcome measure cannot define the broad range of deficits seen in this population. Therefore, it is necessary to define outcome measures that characterize the deficits with greater validity and sensitivity. This review was conducted in 3 stages. Stage I: To evaluate the current use of outcome measures in CSM, PubMed was searched using the name of the outcome measure and the common abbreviation combined with "CSM" or "myelopathy." Stage II: Having identified a lack of appropriate outcome measures, we constructed criteria by which measures appropriate for assessing the various aspects of CSM could be identified. Stage III: A second literature search was then conducted looking at specified outcomes that met these criteria. All literature was reviewed to determine specificity and psychometric properties of outcomes for CSM. Nurick grade, modified Japanese Orthopaedic Association Scale, visual analogue scale (VAS) for pain, Short Form (36) Health Survey (SF-36), and Neck Disability Index were the most commonly cited measures. The Short-Form 36 Health Survey and Myelopathy Disability Index have been validated in the CSM population with multiple studies, whereas the modified Japanese Orthopaedic Association Scale score, Nurick grade, and European Myelopathy Scale each had only one study assessing psychometric characteristics. No validity, reliability, or responsiveness studies were found for the VAS or Neck Disability Index in the CSM population. We recommend that the modified Japanese Orthopaedic Association Scale, Nurick grade, Myelopathy Disability Index, Neck Disability Index, and 30-Meter Walk Test are most appropriate for the assessment of CSM. However, 6 additional outcome measures (QuickDASH, Berg Balance Scale, Graded Redefined Assessment of Strength Sensibility and Prehension, Grip Dynamometer, and GAITRite Analysis) were identified, which provide complementary assessments for CSM. SUMMARY STATEMENTS: There does not exist a single or composite of outcome instruments that measures myelopathy impairment, function/disability, and participation that have also demonstrated reliability, validity, and responsiveness in a CSM population. More work in the development and psychometric evaluation of new or existing measures is necessary to identify the ideal composite of measures to be used in the clinical and research settings. The mJOA, Nurick grade, NDI, MDI, and 30MWT should be adopted in any clinical practice that treats CSM both for screening and clinical follow-up. We propose that clinicians and researchers consider using the ancillary measures identified, such as the QuickDASH, Berg Balance Scale, GRASSP version 1.0, Grip Strength, and GAITRite Analysis. It is highly recommended that baseline and follow-up measurements should be performed in patients with CSM.

Emergency recompression: clinical audit of service delivery at a national level.

PubMed

Ross, John As; Sayer, Martin Dj

2009-03-01

Clinical audit is an essential element to the maintenance or improvement of delivery of any medical service. During the development phase of a National Recompression Registration Service for Scotland, clinical audit was initiated to provide a standardised tool to monitor the quality of outcome with respect to the severity of presentation. A functional audit process was an essential consideration for planned future measurement of treatment efficacy at local (single hyperbaric unit) and national (multiple hyperbaric units) scales. The audit process was designed to be undemanding, robust and informative, irrespective of the experience of treatment centre and of the clinician in charge of treatment. The clinical records from 104 cases of divers with decompression illness were used to derive and evaluate measures of severity and clinical outcome that could be used for audit and quality assurance. The various measures of disease severity were examined against clinical outcome and days spent in care after admission to a hyperbaric unit. An initial version of the clinical audit format that was developed from this process is presented.

Identification of multiple intelligences for high school students in theoretical and applied science courses

NASA Astrophysics Data System (ADS)

Wiseman, D. Kim

Historically educators in the United States have used the Stanford-Binet intelligence test to measure a students' ability in logical/mathematical and linguistic domains. This measurement is being used by a society that has evolved from agrarian and industrial-based economies to what is presently labeled a technological society. As society has changed so have the educational needs of the students who will live in this technological society. This study assessed the multiple intelligences of high school students enrolled in theoretical and applied science (physics and applied physics) courses. Studies have verified that performance and outcomes of students enrolled in these courses are similar in standardized testing but instructional methodology and processes are dissimilar. Analysis of multiple intelligence profiles collected from this study found significant differences in logical/mathematical, bodily/kinesthetic and intrapersonal multiple intelligences of students in theoretical science courses compared to students in applied science courses. Those differences clearly illustrate why it is imperative for educators to expand the definition of intelligence for students entering the new millennium.

Moving beyond Mindfulness: Defining Equanimity as an Outcome Measure in Meditation and Contemplative Research

PubMed Central

Gard, Tim; Hoge, Elizabeth A.; Hölzel, Britta K.; Kerr, Catherine; Lazar, Sara W.; Olendzki, Andrew; Vago, David R.

2014-01-01

In light of a growing interest in contemplative practices such as meditation, the emerging field of contemplative science has been challenged to describe and objectively measure how these practices affect health and well-being. While “mindfulness” itself has been proposed as a measurable outcome of contemplative practices, this concept encompasses multiple components, some of which, as we review here, may be better characterized as equanimity. Equanimity can be defined as an even-minded mental state or dispositional tendency toward all experiences or objects, regardless of their origin or their affective valence (pleasant, unpleasant, or neutral). In this article we propose that equanimity be used as an outcome measure in contemplative research. We first define and discuss the inter-relationship between mindfulness and equanimity from the perspectives of both classical Buddhism and modern psychology and present existing meditation techniques for cultivating equanimity. We then review psychological, physiological, and neuroimaging methods that have been used to assess equanimity, either directly or indirectly. In conclusion, we propose that equanimity captures potentially the most important psychological element in the improvement of well-being, and therefore should be a focus in future research studies. PMID:25750687

Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south.

PubMed

Rimmer, James H; Thirumalai, Mohanraj; Young, Hui-Ju; Pekmezi, Dori; Tracy, Tracy; Riser, Emily; Mehta, Tapan

2018-05-30

Long-term exercise/rehabilitation is an integral component of the continual care for people with multiple sclerosis (MS). However, access to this care, which includes comprehensive exercise/rehabilitation services to people with MS, remains a significant challenge, especially in rural, low-income areas. Telerehabilitation, or what we refer to as teleexercise, can help fill service gaps for underserved MS populations in this region. This pragmatic, cluster randomized controlled effectiveness trial will compare a 12-week, 20 session complementary and alternative medicine (CAM) intervention composed of neurorehabilitative (functional) exercise, yoga and Pilates delivered at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology (TeleCAM), to the same intervention delivered in clinic by a therapist (DirectCAM). Eight hundred and twenty people with MS are being recruited across Alabama, Mississippi and Tennessee. Primary self-reported patient-centered health outcomes are: pain, fatigue, quality of life and physical activity. Secondary outcomes include four physical functioning measures: balance, endurance, gait, and strength. Each of these outcomes will be examined by age, race, sex, severity of MS and other demographics to determine if outcomes are beneficial across all groups (i.e., heterogeneity of treatment effect). The project is important to people with MS and/or caregivers because it aims to reduce their barriers to receiving exercise treatment and increases the convenience and appeal of such programs through technology. Clinical Trials.gov Identifier: NCT03117881. Copyright © 2017. Published by Elsevier Inc.

The multiple hop test: a discriminative or evaluative instrument for chronic ankle instability?

PubMed

Eechaute, Christophe; Bautmans, Ivan; De Hertogh, Willem; Vaes, Peter

2012-05-01

To determine whether the multiple hop test should be used as an evaluative or a discriminative instrument for chronic ankle instability (CAI). Blinded case-control study. : University research laboratory. Twenty-nine healthy subjects (21 men, 8 women, mean age 21.8 years) and 29 patients with CAI (17 men, 12 women, mean age 24.9 years) were selected. Subjects performed a multiple hop test and hopped on 10 different tape markers while trying to avoid any postural correction. Minimal detectable changes (MDC) of the number of balance errors, the time value, and the visual analog scale (VAS) score (perceived difficulty) were calculated as evaluative measures. For the discriminative properties, a receiver operating characteristic curve was determined and the area under curve (AUC), the sensitivity, specificity, diagnostic accuracy (DA), and likelihood ratios (LR) were calculated whether 1, 2, or 3 outcomes were positive. Based on their MDC, outcomes should, respectively, change by more than 7 errors (41%), 6 seconds (15%), and 27 mm (55%, VAS score) before considering it as a real change. Area under curves were, respectively, 79% (errors), 77% (time value), and 65% (VAS score). The most optimal cutoff point was, respectively, 13.5 errors, 35 seconds, and 32.5 mm. When 2 of 3 outcomes were positive, the sensitivity was 86%, the specificity was 79%, the DA was 83%, the positive LR was 4.2, and the negative LR was 0.17. The multiple hop test seems to be more a discriminative instrument for CAI, and its responsiveness needs to be demonstrated.

Multiple courses of antenatal corticosteroids for preterm birth study: 2-year outcomes.

PubMed

Asztalos, Elizabeth V; Murphy, Kellie E; Hannah, Mary E; Willan, Andrew R; Matthews, Stephen G; Ohlsson, Arne; Kelly, Edmond N; Saigal, Saroj; Ross, Susan; Delisle, Marie-France; Amankwah, Kofi; Guselle, Patricia; Gafni, Amiram; Lee, Shoo K; Armson, B Anthony; Sananes, Renee; Tomat, Laura

2010-11-01

The aim of this study was to determine the effects of repeated courses of prenatal corticosteroid therapy versus placebo on death or neurologic impairment among the children enrolled in the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, at 18 to 24 months of age. A total of 2305 infants were eligible for follow-up evaluation; 2104 infants (1069 in the prenatal corticosteroid therapy group and 1035 in the placebo group) were monitored. The primary outcome was death or neurologic impairment, defined as either cerebral palsy or cognitive delay, at 18 to 24 months of age. The secondary outcomes were measurements of growth (height, weight, and head circumference). Children exposed to multiple courses of prenatal corticosteroid therapy had similar rates of death or neurologic impairment, compared with children exposed to placebo (148 children [13.8%] vs 142 children [13.7%]; odds ratio: 1.001[95% confidence interval: 0.75-1.30]; P = .95). They had a mean weight of 11.94 kg, compared with 12.14 kg in the placebo group (P = .04), a mean height of 85.51 cm, compared with 85.46 cm (P = .87), and a mean head circumference of 48.18 cm, compared with 48.25 cm (P = .45). Multiple courses of prenatal corticosteroid therapy, given every 14 days, did not increase or decrease the risk of death or neurologic impairment at 18 to 24 months of age, compared with a single course of prenatal corticosteroid therapy. Continued follow-up monitoring of these children is necessary to assess neurobehavioral function, school performance, and possible susceptibility to disease.

A nonparametric multiple imputation approach for missing categorical data.

PubMed

Zhou, Muhan; He, Yulei; Yu, Mandi; Hsu, Chiu-Hsieh

2017-06-06

Incomplete categorical variables with more than two categories are common in public health data. However, most of the existing missing-data methods do not use the information from nonresponse (missingness) probabilities. We propose a nearest-neighbour multiple imputation approach to impute a missing at random categorical outcome and to estimate the proportion of each category. The donor set for imputation is formed by measuring distances between each missing value with other non-missing values. The distance function is calculated based on a predictive score, which is derived from two working models: one fits a multinomial logistic regression for predicting the missing categorical outcome (the outcome model) and the other fits a logistic regression for predicting missingness probabilities (the missingness model). A weighting scheme is used to accommodate contributions from two working models when generating the predictive score. A missing value is imputed by randomly selecting one of the non-missing values with the smallest distances. We conduct a simulation to evaluate the performance of the proposed method and compare it with several alternative methods. A real-data application is also presented. The simulation study suggests that the proposed method performs well when missingness probabilities are not extreme under some misspecifications of the working models. However, the calibration estimator, which is also based on two working models, can be highly unstable when missingness probabilities for some observations are extremely high. In this scenario, the proposed method produces more stable and better estimates. In addition, proper weights need to be chosen to balance the contributions from the two working models and achieve optimal results for the proposed method. We conclude that the proposed multiple imputation method is a reasonable approach to dealing with missing categorical outcome data with more than two levels for assessing the distribution of the outcome. In terms of the choices for the working models, we suggest a multinomial logistic regression for predicting the missing outcome and a binary logistic regression for predicting the missingness probability.

Outcome of Split Thickness Skin Grafting and Multiple Z-Plasties in Postburn Contractures of Groin and Perineum: A 15-Year Experience

PubMed Central

Sajad, Wani; Hamid, Raashid

2014-01-01

Background. Groin and perineal burn contracture is a rare postburn sequel. Such postburn contractures causes distressing symptoms to the patients and in the management of these contractures, both functional and cosmetic appearance should be the primary concern. Aims. To study the outcome of surgical treatment (STSG and multiple Z-plasties) in postburn contractures of groin and perineum. Material and Methods. We conducted a study of 49 patients, with postburn groin and perineal contractures. Release of contracture with split thickness skin grafting (STSG) was done in 44 (89.79%) patients and release of contracture and closure by multiple Z-plasties was done in 5 (10.21%) patients. Results. Satisfactory functional and cosmetic outcome was seen in 44 (89.79%) patients. Minor secondary contractures of the graft were seen in 3 (6.81%) patients who were managed by physiotherapy and partial recurrence of the contracture in 4 (8.16%) patients required secondary surgery. Conclusion. We conclude that postburn contractures of the groin and perineum can be successfully treated with release of contracture followed by STSG with satisfactory functional and cosmetic results. Long term measures like regular physiotherapy, use of pressure garments, and messaging with emollient creams should not be neglected and should be instituted postoperatively to prevent secondary contractures of the graft and recurrence of the contracture. PMID:24967100

Outcome of split thickness skin grafting and multiple z-plasties in postburn contractures of groin and perineum: a 15-year experience.

PubMed

Sajad, Wani; Hamid, Raashid

2014-01-01

Background. Groin and perineal burn contracture is a rare postburn sequel. Such postburn contractures causes distressing symptoms to the patients and in the management of these contractures, both functional and cosmetic appearance should be the primary concern. Aims. To study the outcome of surgical treatment (STSG and multiple Z-plasties) in postburn contractures of groin and perineum. Material and Methods. We conducted a study of 49 patients, with postburn groin and perineal contractures. Release of contracture with split thickness skin grafting (STSG) was done in 44 (89.79%) patients and release of contracture and closure by multiple Z-plasties was done in 5 (10.21%) patients. Results. Satisfactory functional and cosmetic outcome was seen in 44 (89.79%) patients. Minor secondary contractures of the graft were seen in 3 (6.81%) patients who were managed by physiotherapy and partial recurrence of the contracture in 4 (8.16%) patients required secondary surgery. Conclusion. We conclude that postburn contractures of the groin and perineum can be successfully treated with release of contracture followed by STSG with satisfactory functional and cosmetic results. Long term measures like regular physiotherapy, use of pressure garments, and messaging with emollient creams should not be neglected and should be instituted postoperatively to prevent secondary contractures of the graft and recurrence of the contracture.

The impact of multiple endpoint dependency on Q and I(2) in meta-analysis.

PubMed

Thompson, Christopher Glen; Becker, Betsy Jane

2014-09-01

A common assumption in meta-analysis is that effect sizes are independent. When correlated effect sizes are analyzed using traditional univariate techniques, this assumption is violated. This research assesses the impact of dependence arising from treatment-control studies with multiple endpoints on homogeneity measures Q and I(2) in scenarios using the unbiased standardized-mean-difference effect size. Univariate and multivariate meta-analysis methods are examined. Conditions included different overall outcome effects, study sample sizes, numbers of studies, between-outcomes correlations, dependency structures, and ways of computing the correlation. The univariate approach used typical fixed-effects analyses whereas the multivariate approach used generalized least-squares (GLS) estimates of a fixed-effects model, weighted by the inverse variance-covariance matrix. Increased dependence among effect sizes led to increased Type I error rates from univariate models. When effect sizes were strongly dependent, error rates were drastically higher than nominal levels regardless of study sample size and number of studies. In contrast, using GLS estimation to account for multiple-endpoint dependency maintained error rates within nominal levels. Conversely, mean I(2) values were not greatly affected by increased amounts of dependency. Last, we point out that the between-outcomes correlation should be estimated as a pooled within-groups correlation rather than using a full-sample estimator that does not consider treatment/control group membership. Copyright © 2014 John Wiley & Sons, Ltd.

Speaking Up: How Patient and Physician Voices Shaped a Trial to Improve Goals-of-Care Discussions.

PubMed

Solomon, Rachel; Smith, Cardinale; Kallio, Jay; Fenollosa, Amy; Benerofe, Barbara; Jones, Laurence; Adelson, Kerin; Gonsky, Jason P; Messner, Carolyn; Bickell, Nina A

2017-08-01

Patients with advanced cancer benefit from early goals-of-care (GoC) conversations, but few facilitators are known. We describe the process and outcomes of involving patient and physician stakeholders in the design and development of a trial, funded by the Patient-Centered Outcomes Research Institute (PCORI), to enhance oncologists' communication skills and their propensity to facilitate productive, meaningful GoC discussions with patients with advanced cancer. We recruited oncologists, palliative care physicians, and patient stakeholders to participate in proposal development, intervention design and modification, identification of outcome measures, and refinement of study tools. Formats for exchange included 1:1 structured interviews, workshops, and stakeholder meetings. Patient and physician voices helped craft and implement a study of an intervention to enhance oncologists' ability to facilitate GoC discussions with patients with advanced cancer. Physician inputs guided the creation of an oncologist and palliative care physician "joint visit" intervention at a turning point in disease management. Patient inputs impacted on the language used, outcome measures assessed, and approaches used to introduce patients to the intervention visit. Stakeholder input informed the development of a novel intervention that physicians seemed to find both valuable and in sync with their needs and their practice schedules. Where communication about difficult subjects and shared decision making are involved, including multiple stakeholder groups in study design, implementation, and outcomes measurement may have far-reaching effects.

The Additional Contribution of White Matter Hyperintensity Location to Post-stroke Cognitive Impairment: Insights From a Multiple-Lesion Symptom Mapping Study.

PubMed

Zhao, Lei; Wong, Adrian; Luo, Yishan; Liu, Wenyan; Chu, Winnie W C; Abrigo, Jill M; Lee, Ryan K L; Mok, Vincent; Shi, Lin

2018-01-01

White matter hyperintensities (WMH) are common in acute ischemic stroke patients. Although WMH volume has been reported to influence post-stroke cognition, it is still not clear whether WMH location, independent of acute ischemic lesion (AIL) volume and location, contributes to cognitive impairment after stroke. Here, we proposed a multiple-lesion symptom mapping model that considers both the presence of WMH and AIL to measure the additional contribution of WMH locations to post-stroke cognitive impairment. Seventy-six first-ever stroke patients with AILs in the left hemisphere were examined by Montreal Cognitive Assessment (MoCA) at baseline and 1 year after stroke. The association between the location of AIL and WMH and global cognition was investigated by a multiple-lesion symptom mapping (MLSM) model based on support vector regression (SVR). To explore the relative merits of MLSM over the existing lesion-symptom mapping approaches with only AIL considered (mass-univariate VLSM and SVR-LSM), we measured the contribution of the significant AIL and/or WMH clusters from these models to post-stroke cognitive impairment. In addition, we compared the significant WMH locations identified by the optimal SVR-MLSM model for cognitive impairment at baseline and 1 year post stroke. The identified strategic locations of WMH significantly contributed to the prediction of MoCA at baseline (short-term) and 1 year (long-term) after stroke independent of the strategic locations of AIL. The significant clusters of WMH for short-term and long-term post-stroke cognitive impairment were mainly in the corpus callosum, corona radiata, and posterior thalamic radiation. We noted that in some regions, the AIL clusters that were significant for short-term outcome were no longer significant for long-term outcome, and interestingly more WMH clusters in these regions became significant for long-term outcome compared to short-term outcome. This indicated that there are some regions where local WMH burden has larger impact than AIL burden on the long-term post-stroke cognitive impairment. In consequence, SVR-MLSM was effective in identifying the WMH locations that have additional impact on post-stroke cognition on top of AIL locations. Such a method can also be applied to other lesion-behavior studies where multiple types of lesions may have potential contributions to a specific behavior.

Food environments and dietary intakes among adults: does the type of spatial exposure measurement matter? A systematic review.

PubMed

Bivoltsis, Alexia; Cervigni, Eleanor; Trapp, Gina; Knuiman, Matthew; Hooper, Paula; Ambrosini, Gina Leslie

2018-06-09

The relationships between food environments and dietary intake have been assessed via a range of methodologically diverse measures of spatial exposure to food outlets, resulting in a largely inconclusive body of evidence, limiting informed policy intervention. This systematic review aims to evaluate the influence of methodological choice on study outcomes by examining the within-study effect of availability (e.g., counts) versus accessibility (e.g., proximity) spatial exposure measures on associations with diet. (PROSPERO registration: CRD42018085250). PubMed, Web of Science, Scopus and ScienceDirect databases were searched for empirical studies from 1980 to 2017, in the English language, involving adults and reporting on the statistical association between a dietary outcome and spatial exposure measures of both availability and accessibility. Studies were appraised using an eight-point quality criteria with a narrative synthesis of results. A total of 205 associations and 44 relationships (i.e., multiple measures of spatial exposure relating to a particular food outlet type and dietary outcome) were extracted from 14 eligible articles. Comparative measures were dominated by counts (availability) and proximity (accessibility). Few studies compared more complex measures and all counts were derived from place-based measures of exposure. Sixteen of the 44 relationships had a significant effect involving an availability measure whilst only 8 had a significant effect from an accessibility measure. The largest effect sizes in relationships were mostly for availability measures. After stratification by scale, availability measure had the greatest effect size in 139 of the 176 pairwise comparisons. Of the 33% (68/205) of associations that reached significance, 53/68 (78%) were from availability measures. There was no relationship between study quality and reported study outcomes. The limited evidence suggests that availability measures may produce significant and greater effect sizes than accessibility measures. However, both availability and accessibility measures may be important concepts of spatial exposure depending on the food outlet type and dietary outcome examined. More studies reporting on multi-method effects are required to differentiate findings by the type of spatial exposure assessment and build an evidence base regarding the appropriateness and robustness of measures under different circumstances.

Integrating data from multiple sources for data completeness in a web-based registry for pediatric renal transplantation--the CERTAIN Registry.

PubMed

Köster, Lennart; Krupka, Kai; Höcker, Britta; Rahmel, Axel; Samuel, Undine; Zanen, Wouter; Opelz, Gerhard; Süsal, Caner; Döhler, Bernd; Plotnicki, Lukasz; Kohl, Christian D; Knaup, Petra; Tönshoff, Burkhard

2015-01-01

Patient registries are a useful tool to measure outcomes and compare the effectiveness of therapies in a specific patient population. High data quality and completeness are therefore advantageous for registry analysis. Data integration from multiple sources may increase completeness of the data. The pediatric renal transplantation registry CERTAIN identified Eurotransplant (ET) and the Collaborative Transplant Study (CTS) as possible partners for data exchange. Import and export interfaces with CTS and ET were implemented. All parties reached their projected goals and benefit from the exchange.

Epidemiologic research using probabilistic outcome definitions.

PubMed

Cai, Bing; Hennessy, Sean; Lo Re, Vincent; Small, Dylan S

2015-01-01

Epidemiologic studies using electronic healthcare data often define the presence or absence of binary clinical outcomes by using algorithms with imperfect specificity, sensitivity, and positive predictive value. This results in misclassification and bias in study results. We describe and evaluate a new method called probabilistic outcome definition (POD) that uses logistic regression to estimate the probability of a clinical outcome using multiple potential algorithms and then uses multiple imputation to make valid inferences about the risk ratio or other epidemiologic parameters of interest. We conducted a simulation to evaluate the performance of the POD method with two variables that can predict the true outcome and compared the POD method with the conventional method. The simulation results showed that when the true risk ratio is equal to 1.0 (null), the conventional method based on a binary outcome provides unbiased estimates. However, when the risk ratio is not equal to 1.0, the traditional method, either using one predictive variable or both predictive variables to define the outcome, is biased when the positive predictive value is <100%, and the bias is very severe when the sensitivity or positive predictive value is poor (less than 0.75 in our simulation). In contrast, the POD method provides unbiased estimates of the risk ratio both when this measure of effect is equal to 1.0 and not equal to 1.0. Even when the sensitivity and positive predictive value are low, the POD method continues to provide unbiased estimates of the risk ratio. The POD method provides an improved way to define outcomes in database research. This method has a major advantage over the conventional method in that it provided unbiased estimates of risk ratios and it is easy to use. Copyright © 2014 John Wiley & Sons, Ltd.

Relationship of patient characteristics and rehabilitation services to outcomes following spinal cord injury: The SCIRehab Project

PubMed Central

Whiteneck, Gale; Gassaway, Julie; Dijkers, Marcel P.; Heinemann, Allen W.; Kreider, Scott E. D.

2012-01-01

Background/objective To examine associations of patient characteristics along with treatment quantity delivered by seven clinical disciplines during inpatient spinal cord injury (SCI) rehabilitation with outcomes at rehabilitation discharge and 1-year post-injury. Methods Six inpatient SCI rehabilitation centers enrolled 1376 patients during the 5-year SCIRehab study. Clinicians delivering standard care documented details of treatment. Outcome data were derived from SCI Model Systems Form I and II and a project-specific interview conducted at approximately 1-year post-injury. Regression modeling was used to predict outcomes; models were cross-validated by examining relative shrinkage of the original model R2 using 75% of the dataset to the R2 for the same outcome using a validation subsample. Results Patient characteristics are strong predictors of outcome; treatment duration adds slightly more predictive power. More time in physical therapy was associated positively with motor Functional Independence Measure at discharge and the 1-year anniversary, CHART Physical Independence, Social Integration, and Mobility dimensions, and smaller likelihood of rehospitalization after discharge and reporting of pressure ulcer at the interview. More time in therapeutic recreation also had multiple similar positive associations. Time spent in other disciplines had fewer and mixed relationships. Seven models validated well, two validated moderately well, and four validated poorly. Conclusion Patient characteristics explain a large proportion of variation in multiple outcomes after inpatient rehabilitation. The total amount of treatment received during rehabilitation from each of seven disciplines explains little additional variance. Reasons for this and the phenomenon that sometimes more hours of service predict poorer outcome, need additional study. Note This is the first of nine articles in the SCIRehab series. PMID:23318033

Adherence and health literacy as related to outcome of patients treated for rheumatoid arthritis : Analyses of a large-scale observational study.

PubMed

Kuipers, J G; Koller, M; Zeman, F; Müller, K; Rüffer, J U

2018-04-24

Disabilities in daily living and quality of life are key endpoints for evaluating the treatment outcome for rheumatoid arthritis (RA). Factors possibly contributing to good outcome are adherence and health literacy. The survey included a representative nationwide sample of German rheumatologists and their patients with RA. The physician questionnaire included the disease activity score (DAS28) and medical prescriptions. The patient questionnaire included fatigue (EORTC QLQ-FA13), health assessment questionnaire (HAQ), quality of life (SF-12), health literacy (HELP), and patients' listings of their medications. Adherence was operationalized as follows: patient-reported (CQR5), behavioral (concordance between physicians' and patients' listings of medications), physician-assessed, and a combined measure of physician rating (1 = very adherent, 0 = less adherent) and the match between physicians' prescriptions and patients' accounts of their medications (1 = perfect match, 0 = no perfect match) that yielded three categories of adherence: high, medium, and low. Simple and multiple linear regressions (controlling for age, sex, smoking, drinking alcohol, and sport) were calculated using adherence and health literacy as predictor variables, and disease activity and patient-reported outcomes as dependent variables. 708 pairs of patient and physician questionnaires were analyzed. The mean patient age (73% women) was 60 years (SD = 12). Multiple regression analyses showed that high adherence was significantly associated with 5/7 outcome variables and health literacy with 7/7 outcome variables. Adherence and health literacy had weak but consistent effects on most outcomes. Thus, enhancing adherence and understanding of medical information could improve outcome, which should be investigated in future interventional studies.

Univariate Analysis of Multivariate Outcomes in Educational Psychology.

ERIC Educational Resources Information Center

Hubble, L. M.

1984-01-01

The author examined the prevalence of multiple operational definitions of outcome constructs and an estimate of the incidence of Type I error rates when univariate procedures were applied to multiple variables in educational psychology. Multiple operational definitions of constructs were advocated and wider use of multivariate analysis was…

Pulse Oximeter Plethysmograph Estimate of Pulsus Paradoxus as a Measure of Acute Asthma Exacerbation Severity and Response to Treatment.

PubMed

Arnold, Donald H; Wang, Li; Hartert, Tina V

2016-03-01

Pulsus paradoxus is one of the few objective bedside measures of acute asthma exacerbation severity but is difficult to measure in tachypneic and tachycardic patients and in noisy clinical environments. Our primary objective was to examine whether pulse oximeter plethysmograph estimate of pulsus paradoxus (PEP) is associated with physiologic and symptom measures of acute exacerbation severity (airway resistance by impulse oscillometry [%IOS] and the Acute Asthma Intensity Research Score [AAIRS]). Secondary objectives were to validate the previous association of PEP with percent predicted forced expiratory volume in 1 second (%FEV1 ) and to examine associations of change of PEP with change of these outcomes after 2 hours of treatment. This was a secondary analysis of data from a prospective observational study of patients aged 5-17 years with acute asthma exacerbations. The predictor variable, PEP, was measured using a dedicated pulse oximeter and waveform analysis program. Outcome measures included the AAIRS, %IOS, and %FEV1 at baseline and after 2 hours of treatment. We examined associations of PEP with %IOS and the AAIRS at baseline using multiple linear regression models adjusted for age, sex, and race. As secondary analyses we similarly examined the association of PEP with %FEV1 at baseline and change of PEP with change of %IOS, the AAIRS, and %FEV1 after 2 hours of treatment using multiple linear regression models adjusted for the baseline value of the outcome measure and the AAIRS. Among 684 participants (61% males; 61% African American) there were associations of baseline PEP with %IOS, the AAIRS, and %FEV1 (p < 0.001). Change of PEP after 2 hours of treatment was associated with change of %FEV1 (p < 0.001) and change of the AAIRS (p = 0.01) but not with change of %IOS (p = 0.60). PEP demonstrates criterion validity in predicting baseline %IOS, the AAIRS, and %FEV1 , and responsiveness to change of the AAIRS and %FEV1 . Data contained in the oximeter plethysmograph waveform might be utilized as a continuous, objective measure of acute asthma exacerbation severity and real-time response to treatment. © 2016 by the Society for Academic Emergency Medicine.

A human factors framework and study of the effect of nursing workload on patient safety and employee quality of working life

PubMed Central

Holden, Richard J.; Scanlon, Matthew C.; Patel, Neal R.; Kaushal, Rainu; Escoto, Kamisha Hamilton; Brown, Roger L.; Alper, Samuel J.; Arnold, Judi M.; Shalaby, Theresa M.; Murkowski, Kathleen; Karsh, Ben-Tzion

2010-01-01

Backgrounds Nursing workload is increasingly thought to contribute to both nurses’ quality of working life and quality/safety of care. Prior studies lack a coherent model for conceptualizing and measuring the effects of workload in health care. In contrast, we conceptualized a human factors model for workload specifying workload at three distinct levels of analysis and having multiple nurse and patient outcomes. Methods To test this model, we analyzed results from a cross-sectional survey of a volunteer sample of nurses in six units of two academic tertiary care pediatric hospitals. Results Workload measures were generally correlated with outcomes of interest. A multivariate structural model revealed that: the unit-level measure of staffing adequacy was significantly related to job dissatisfaction (path loading = .31) and burnout (path loading = .45); the task-level measure of mental workload related to interruptions, divided attention, and being rushed was associated with burnout (path loading = .25) and medication error likelihood (path loading = 1.04). Job-level workload was not uniquely and significantly associated with any outcomes. Discussion The human factors engineering model of nursing workload was supported by data from two pediatric hospitals. The findings provided a novel insight into specific ways that different types of workload could affect nurse and patient outcomes. These findings suggest further research and yield a number of human factors design suggestions. PMID:21228071

A human factors framework and study of the effect of nursing workload on patient safety and employee quality of working life.

PubMed

Holden, Richard J; Scanlon, Matthew C; Patel, Neal R; Kaushal, Rainu; Escoto, Kamisha Hamilton; Brown, Roger L; Alper, Samuel J; Arnold, Judi M; Shalaby, Theresa M; Murkowski, Kathleen; Karsh, Ben-Tzion

2011-01-01

Nursing workload is increasingly thought to contribute to both nurses' quality of working life and quality/safety of care. Prior studies lack a coherent model for conceptualising and measuring the effects of workload in healthcare. In contrast, we conceptualised a human factors model for workload specifying workload at three distinct levels of analysis and having multiple nurse and patient outcomes. To test this model, we analysed results from a cross-sectional survey of a volunteer sample of nurses in six units of two academic tertiary care paediatric hospitals. Workload measures were generally correlated with outcomes of interest. A multivariate structural model revealed that: the unit-level measure of staffing adequacy was significantly related to job dissatisfaction (path loading=0.31) and burnout (path loading=0.45); the task-level measure of mental workload related to interruptions, divided attention, and being rushed was associated with burnout (path loading=0.25) and medication error likelihood (path loading=1.04). Job-level workload was not uniquely and significantly associated with any outcomes. The human factors engineering model of nursing workload was supported by data from two paediatric hospitals. The findings provided a novel insight into specific ways that different types of workload could affect nurse and patient outcomes. These findings suggest further research and yield a number of human factors design suggestions.

Predicting sugar-sweetened behaviours with theory of planned behaviour constructs: Outcome and process results from the SIPsmartER behavioural intervention

PubMed Central

Zoellner, Jamie M.; Porter, Kathleen J.; Chen, Yvonnes; Hedrick, Valisa E.; You, Wen; Hickman, Maja; Estabrooks, Paul A.

2017-01-01

Objective Guided by the theory of planned behaviour (TPB) and health literacy concepts, SIPsmartER is a six-month multicomponent intervention effective at improving SSB behaviours. Using SIPsmartER data, this study explores prediction of SSB behavioural intention (BI) and behaviour from TPB constructs using: (1) cross-sectional and prospective models and (2) 11 single-item assessments from interactive voice response (IVR) technology. Design Quasi-experimental design, including pre- and post-outcome data and repeated-measures process data of 155 intervention participants. Main Outcome Measures Validated multi-item TPB measures, single-item TPB measures, and self-reported SSB behaviours. Hypothesised relationships were investigated using correlation and multiple regression models. Results TPB constructs explained 32% of the variance cross sectionally and 20% prospectively in BI; and explained 13–20% of variance cross sectionally and 6% prospectively. Single-item scale models were significant, yet explained less variance. All IVR models predicting BI (average 21%, range 6–38%) and behaviour (average 30%, range 6–55%) were significant. Conclusion Findings are interpreted in the context of other cross-sectional, prospective and experimental TPB health and dietary studies. Findings advance experimental application of the TPB, including understanding constructs at outcome and process time points and applying theory in all intervention development, implementation and evaluation phases. PMID:28165771

A Review of Preventative Methods against Human Leishmaniasis Infection

PubMed Central

Stockdale, Lisa; Newton, Robert

2013-01-01

Background Leishmaniasis is an intracellular parasitic infection transmitted to humans via the sandfly. Approximately 350 million people are at risk of contracting the disease and an estimated 1.6 million new cases occur annually. Of the two main forms, visceral and cutaneous, the visceral form is fatal in 85–90% of untreated cases. Aims This literature review aims to identify and evaluate the current evidence base for the use of various preventative methods against human leishmaniasis. Methods A literature search was performed of the relevant database repositories for primary research conforming to a priori inclusion and exclusion criteria. Results A total of 84 controlled studies investigating 12 outcome measures were identified, implementing four broad categories of preventative interventions: animal reservoir control, vector population control, human reservoir control and a category for multiple concurrently implemented interventions. The primary studies investigated a heterogeneous mix of outcome measures using a range of different methods. Conclusions This review highlights an absence of research measuring human-specific outcomes (35% of the total) across all intervention categories. The apparent inability of study findings to be generalizable across different geographic locations, points towards gaps in knowledge regarding the biology of transmission of Leishmania in different settings. More research is needed which investigates human infection as the primary outcome measure as opposed to intermediate surrogate markers, with a focus on developing a human vaccine. PMID:23818997

The Effect of Blood Alcohol Level and Pre-Injury Chronic Alcohol Use on Outcome from Severe Traumatic Brain Injury in Hispanics, Anglo-Caucasians, and African Americans

PubMed Central

O’Dell, Keira M.; Hannay, H. Julia; Biney, Fedora O.; Robertson, Claudia S.; Tian, T. Siva

2012-01-01

Objective To examine a) ethnic differences in blood alcohol level (BAL) and pre-injury chronic alcohol use (PI-ETOH) within a severe closed head injury (CHI) sample, and b) the main and interaction effects of BAL, PI-ETOH, and ethnicity on functional outcome following severe CHI. Participants 434 Hispanic, Anglo-Caucasian, and African American individuals with severe CHI. Design Retrospective cohort study. Setting Consecutive admissions to a level one trauma center. Main measures BAL upon admission to the trauma center was collected for each patient. Additional information regarding PI-ETOH was collected in a subset of patients (N=116). Functional outcome was measured using the Disability Rating Scale (DRS) at 6 months post-injury. Results A one-way ANOVA revealed ethnic differences in mean BAL. Hierarchical multiple regression indicated that BAL did not predict DRS outcomes after controlling for pertinent covariates. An interaction effect between PI-ETOH and ethnicity was observed, such that presence of chronic alcohol use predicted worse functional outcome for Anglo-Caucasians and African Americans, but more favorable outcome for Hispanics. Conclusions Ethnic differences in BALs within our severe TBI sample mirrored ethnic drinking patterns observed in the general population, with Hispanics having the highest BALs. A paradoxical relationship between PI-ETOH and functional outcome was observed for Hispanics. PMID:22955101

High glucose variability is associated with poor neurodevelopmental outcomes in neonatal hypoxic ischemic encephalopathy.

PubMed

Al Shafouri, N; Narvey, M; Srinivasan, G; Vallance, J; Hansen, G

2015-01-01

In neonatal hypoxic ischemic encephalopathy (HIE), hypo- and hyperglycemia have been associated with poor outcomes. However, glucose variability has not been reported in this population. To examine the association between serum glucose variability within the first 24 hours and two-year neurodevelopmental outcomes in neonates cooled for HIE. In this retrospective cohort study, glucose, clinical and demographic data were documented from 23 term newborns treated with whole body therapeutic hypothermia. Severe neurodevelopmental outcomes from planned two-year assessments were defined as the presence of any one of the following: Gross Motor Function Classification System levels 3 to 5, Bayley III Motor Standard Score <70, Bayley III Language Score <70 and Bayley III Cognitive Standard Score <70. The neurodevelopmental outcomes from 8 of 23 patients were considered severe, and this group demonstrated a significant increase of mean absolute glucose (MAG) change (-0.28 to -0.03, 95% CI, p = 0.032). There were no significant differences between outcome groups with regards to number of patients with hyperglycemic means, one or multiple hypo- or hyperglycemic measurement(s). There were also no differences between both groups with mean glucose, although mean glucose standard deviation was approaching significance. Poor neurodevelopmental outcomes in whole body cooled HIE neonates are significantly associated with MAG changes. This information may be relevant for prognostication and potential management strategies.

Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation

PubMed Central

Cooney, Rachel M; Warren, Bryan F; Altman, Douglas G; Abreu, Maria T; Travis, Simon PL

2007-01-01

Clinical trials on novel drug therapies require clear criteria for patient selection and agreed definitions of disease remission. This principle has been successfully applied in the field of rheumatology where agreed disease scoring systems have allowed multi-centre collaborations and facilitated audit across treatment centres. Unfortunately in ulcerative colitis this consensus is lacking. Thirteen scoring systems have been developed but none have been properly validated. Most trials choose different endpoints and activity indices, making comparison of results from different trials extremely difficult. International consensus on endoscopic, clinical and histological scoring systems is essential as these are the key components used to determine entry criteria and outcome measurements in clinical trials on ulcerative colitis. With multiple new therapies under development, there is a pressing need for consensus to be reached. PMID:17592647

Psychometric Study of the Aberrant Behavior Checklist in Fragile X Syndrome and Implications for Targeted Treatment

ERIC Educational Resources Information Center

Sansone, Stephanie M.; Widaman, Keith F.; Hall, Scott S.; Reiss, Allan L.; Lightbody, Amy; Kaufmann, Walter E.; Berry-Kravis, Elizabeth; Lachiewicz, Ave; Brown, Elaine C.; Hessl, David

2012-01-01

Animal studies elucidating the neurobiology of fragile X syndrome (FXS) have led to multiple controlled trials in humans, with the Aberrant Behavior Checklist-Community (ABC-C) commonly adopted as a primary outcome measure. A multi-site collaboration examined the psychometric properties of the ABC-C in 630 individuals (ages 3-25) with FXS using…

Redesigning Systems of School Accountability: A Multiple Measures Approach to Accountability and Support

ERIC Educational Resources Information Center

Bae, Soung

2018-01-01

The challenges facing our children in the 21st century are rapidly changing. As a result, schools bear a greater responsibility to prepare students for college, career, and life and must be held accountable for more than just testing and reporting on a narrow set of outcomes aimed at minimum levels of competency. Thus, scholars, educators, and…

Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981–2012

PubMed Central

Travers, Karin; Sallum, Rachel H; Burns, Meghan D; Barr, Charles E; Beattie, Mary S; Pashos, Chris L; Luce, Bryan R

2015-01-01

Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. Methods Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed. Results Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices (n = 193, 34%), specific drugs (n = 173, 31%), procedures (n = 29, 5%), or particular diseases (n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular (n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns (n = 122, 22%), patient-reported outcomes (n = 106, 19%), disease epidemiology/natural history (n = 69, 12%), and economic outcomes (n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time. Conclusions The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25079108

The development of leadership outcome-indicators evaluating the contribution of clinical specialists and advanced practitioners to health care: a secondary analysis.

PubMed

Elliott, Naomi; Begley, Cecily; Kleinpell, Ruth; Higgins, Agnes

2014-05-01

To report a secondary analysis of data collected from the case study phase of a national study of advanced practitioners and to develop leadership outcome-indicators appropriate for advanced practitioners. In many countries, advanced practitioners in nursing and midwifery have responsibility as leaders for health care development, but without having leadership outcome measures available they are unable to demonstrate the results of their activities. In Ireland, a sequential mixed method research study was used to develop a validated tool for the evaluation of clinical specialists and advanced practitioners. Despite strong evidence of leadership activities, few leadership-specific outcomes were generated from the primary analysis. Secondary analysis of a multiple case study data set. Data set comprised 23 case studies of advanced practitioner/clinical specialists from 13 sites across each region in Ireland from all divisions of the Nursing Board Register. Data were collected 2008-2010. Data sources included non-participant observation (n = 92 hours) of advanced practitioners in practice, interviews with clinicians (n = 21), patients (n = 20) and directors of nursing/midwifery (n = 13) and documents. Analysis focused on leadership outcome-indicator development in line with the National Health Service's Good Indicators Guide. The four categories of leadership outcomes for advanced practitioner developed were as follows: (i) capacity and capability building of multidisciplinary team; (ii) measure of esteem; (iii) new initiatives for clinical practice and healthcare delivery; and (iv) clinical practice based on evidence. The proposed set of leadership outcome-indicators derived from a secondary analysis captures the complexity of leadership in practice. They add to existing clinical outcomes measuring advanced practice. © 2013 John Wiley & Sons Ltd.

Validation of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Tests Against the Foot and Ankle Outcome Score for 6 Common Foot and Ankle Pathologies.

PubMed

Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J

2017-08-01

The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient outcomes in foot and ankle research through improved precision and reduced respondent burden. Level II, prospective comparative study.

Accounting for natural resources and environmental sustainability: linking ecosystem services to human well-being.

PubMed

Jordan, Stephen J; Hayes, Sharon E; Yoskowitz, David; Smith, Lisa M; Summers, J Kevin; Russell, Marc; Benson, William H

2010-03-01

One of society's greatest challenges is to sustain natural resources while promoting economic growth and quality of life. In the face of this challenge, society must measure the effectiveness of programs established to safeguard the environment. The impetus for demonstrating positive results from government-sponsored research and regulation in the United States comes from Congress (General Accountability Office; GAO) and the Executive Branch (Office of Management and Budget; OMB). The message is: regulatory and research programs must demonstrate outcomes that justify their costs. Although the concept is simple, it is a complex problem to demonstrate that environmental research, policies, and regulations cause measurable changes in environmental quality. Even where changes in environmental quality can be tracked reliably, the connections between government actions and environmental outcomes seldom are direct or straightforward. In this article, we describe emerging efforts (with emphasis on the role of the U.S. Environmental Protection Agency; EPA) to frame and measure environmental outcomes in terms of ecosystem services and values-societally and ecologically meaningful metrics for gauging how well we manage environmental resources. As examples of accounting for outcomes and values, we present a novel, low-cost method for determining relative values of multiple ecosystem services, and describe emerging research on indicators of human well-being.

A Prospective Observational Comparison Between Arm and Wrist Blood Pressure During Scheduled Cesarean Delivery.

PubMed

Sebbag, Ilana; Massey, Simon R; Albert, Arianne Y K; Dube, Alison; Gunka, Vit; Douglas, M Joanne

2015-09-01

Shivering is common during cesarean delivery (CD) under neuraxial anesthesia and may disrupt the measurement of noninvasive blood pressure (BP). BP measured at the wrist may be less affected by shivering. There have been no studies comparing trends in BP measured on the upper arm and wrist. We hypothesized that wrist systolic blood pressure (sBP) would accurately trend with upper arm sBP measurements (agree within a limit of ±10%) in parturients undergoing elective CD under spinal anesthesia or combined spinal-epidural anesthesia. After initiation of spinal anesthesia, BP measurements were obtained simultaneously from the upper arm and wrist on opposite arms. The interval between measurements was 1 to 2 minutes, and data were collected for 20 minutes or until delivery. The primary outcome was agreement in dynamic changes in sBP measurements between the upper arm and the wrist. Bland-Altman plots indicating the levels of agreement between the methods were drawn for baseline measurements, over multiple measurements, and over multiple measurements on percentage change from baseline. Forty-nine patients were recruited and completed the study. The wrist sBP tended to overestimate the upper sBP for both baseline data (sBP bias = 13.4 mm Hg; 95% confidence interval = +10.4 to +16.4 mm Hg) and data obtained over multiple measurements (sBP bias = 12.8 mm Hg; 95% confidence interval = +9.3 to +16.3 mm Hg). For change in sBP from baseline over multiple measurements, the mean difference between the wrist and the arm sBP was -0.2 percentage points (99% limits of agreement -25 to +25 percentage points). The wrist measurement overestimated the reading relative to the upper arm measurement for multiple measurements over time. However, when the time series for each subject was examined for percentage change from baseline, the 2 methods mirrored each other in most cases. Nevertheless, our hypothesis was rejected as the limits of agreement were higher than ±10%. This finding suggests that wrist BP may not be an accurate method of detecting hypotension or hypertension during spinal or combined spinal-epidural anesthesia for CD.

Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.

PubMed

Anderson, Jennifer J; Bolognese, James A; Felson, David T

2003-11-01

Isolated studies have suggested that continuous measures of response may be better than predefined, dichotomous definitions (e.g., the American College of Rheumatology 20% improvement criteria [ACR20]) for discriminating between rheumatoid arthritis (RA) treatments. Our goal was to determine the statistical power of predefined dichotomous outcome measures (termed "a priori"), compared with that of continuous measures derived from trial data in which there was no predefined response threshold (termed "data driven"), and to evaluate the sensitivity to change of these measures in the context of different treatments and early versus later-stage disease. In order to generalize beyond results from a single trial, we performed simulation studies. We obtained summary data from trials comparing disease-modifying antirheumatic drugs (DMARDs) and from comparative coxib-placebo trials to test the power of 2 a priori outcomes, the ACR20 and improvement of the Disease Activity Score (DDAS), as well as 2 data-driven outcomes. We studied patients with early RA and those with later-stage RA (duration of <4 years and 4-9 years, respectively). We performed simulation studies, using the interrelationship of ACR core set measures in the trials to generate multiple trial data sets consistent with the original data. The data-driven outcomes had greater power than did the a priori measures. The DMARD comparison was more powerful in early disease than in later-stage disease (the sample sizes needed to achieve 80% power for the most powerful test were 64 for early disease versus 100 for later disease), but the coxib-versus-placebo comparison was less powerful in early disease than in later disease (the sample sizes needed to achieve 80% power were 200 and 100, respectively). When the effects of treatment on core set items were small and/or inconsistent, power was reduced, particularly for a less broadly based outcome (e.g., DDAS) compared with the ACR20. The simulation studies demonstrate that data-driven outcome definitions can provide better sensitivity to change than does the ACR20 or DDAS. Using such methods would improve power, but at the expense of trial standardization. The studies also show how patient population and treatment characteristics affect the power of specific outcome measures in RA clinical trials, and provide quantification of those effects.

Psychometric properties of the Dutch version of the self-sufficiency matrix (SSM-D).

PubMed

Fassaert, Thijs; Lauriks, Steve; van de Weerd, Stef; Theunissen, Jan; Kikkert, Martijn; Dekker, Jack; Buster, Marcel; de Wit, Matty

2014-07-01

Measuring treatment outcomes can be challenging in patients who experience multiple interlinked problems, as is the case in public mental health care (PMHC). This study describes the development and psychometric properties of a Dutch version of the self-sufficiency matrix (SSM-D), an instrument that measures outcomes and originates from the US. In two different settings, clients were rated using the SSM-D in combination with the Health of the Nation Outcome Scales (HoNOS) and the Camberwell assessment of need short appraisal schedule (CANSAS). The results provided support for adequate psychometric properties of the SSM-D. The SSM-D had a solid single factor structure and internal consistency of the scale was excellent. In addition, convergent validity of the SSM-D was indicated by strong correlations between HoNOS and CANSAS, as well as between several subdomains. Further research is needed to establish whether the results presented here can be obtained in other PMHC settings.

Accounting for the Process of Disablement and Longitudinal Outcomes Among the Near Elderly and Elderly.

PubMed

Rupp, Kalman; Dushi, Irena

2017-01-01

Using a new disability measure applicable to both the near elderly and elderly population, we track respondents aged 51-61 in 1992 from the Health and Retirement Study and account for their status over 20 years. We demonstrate that to screen in as disabled and to screen out as nondisabled require different analytic strategies and use multiple indicators to establish three groups: disabled, nondisabled, and a residual category with ambiguous status. We use work-disability and Supplemental Security Income/Disability Insurance (SSI/DI) receipt for testing distributional outcomes and assessing face validity of our disability measure. Selective attrition due to death and institutionalization is substantial over 20 years. Persistent disability is the dominant adverse outcome of initial disability shock. Overtime exits due to death become progressively more important; 44% disabled at baseline are dead by Wave 11 compared to 21% for nondisabled. Disability status at baseline is associated with financial insecurity persisting to Wave 11 among survivors.

Ontologies to improve chronic disease management research and quality improvement studies - a conceptual framework.

PubMed

Liyanage, Harshana; Liaw, Siaw-Teng; Kuziemsky, Craig; de Lusignan, Simon

2013-01-01

There is a growing burden of chronic non-communicable disease (CNCD). Managing CNCDs requires use of multiple sources of health and social care data, and information about coordination and outcomes. Many people with CNCDs have multimorbidity. Problems with data quality exacerbate challenges in measuring quality and health outcomes especially where there is multimorbidity. We have developed an ontological toolkit to support research and quality improvement studies in CNCDs using heterogeneous data, with diabetes mellitus as an exemplar. International experts held a workshop meeting, with follow up discussions and consensus building exercise. We generated conceptual statements about problems with a CNCD that ontologies might support, and a generic reference model. There were varying degrees of consensus. We propose a set of tools, and a four step method: (1) Identification and specification of data sources; (2) Conceptualisation of semantic meaning; (3) How available routine data can be used as a measure of the process or outcome of care; (4) Formalisation and validation of the final ontology.

A history of health-related quality of life outcomes in psychiatry.

PubMed

Revicki, Dennis A; Kleinman, Leah; Cella, David

2014-06-01

Health-related quality of life (HRQoL) is a multidimensional concept that includes subjective reports of symptoms, side effects, functioning in multiple life domains, and general perceptions of life satisfaction and quality. Rather than estimating it from external observations, interview, or clinical assessment, it is best measured by direct query. Due to a perception that respondents may not be reliable or credible, there has been some reluctance to use self-report outcomes in psychiatry. More recently, and increasingly, HRQoL assessment through direct patient query has become common when evaluating a range of psychiatric, psychological, and social therapies. With few exceptions, psychiatric patients are credible and reliable reporters of this information. This article summarizes studies that highlight the development, validation, and application of HRQoL measures in psychiatry. Thoughtful application of these tools in psychiatric research can provide a much-needed patient perspective in the future of comparative effectiveness research, patient-centered outcomes research, and clinical care.

Ranking Surgical Residency Programs: Reputation Survey or Outcomes Measures?

PubMed

Wilson, Adam B; Torbeck, Laura J; Dunnington, Gary L

2015-01-01

The release of general surgery residency program rankings by Doximity and U.S. News & World Report accentuates the need to define and establish measurable standards of program quality. This study evaluated the extent to which program rankings based solely on peer nominations correlated with familiar program outcomes measures. Publicly available data were collected for all 254 general surgery residency programs. To generate a rudimentary outcomes-based program ranking, surgery programs were rank-ordered according to an average percentile rank that was calculated using board pass rates and the prevalence of alumni publications. A Kendall τ-b rank correlation computed the linear association between program rankings based on reputation alone and those derived from outcomes measures to validate whether reputation was a reasonable surrogate for globally judging program quality. For the 218 programs with complete data eligible for analysis, the mean board pass rate was 72% with a standard deviation of 14%. A total of 60 programs were placed in the 75th percentile or above for the number of publications authored by program alumni. The correlational analysis reported a significant correlation of 0.428, indicating only a moderate association between programs ranked by outcomes measures and those ranked according to reputation. Seventeen programs that were ranked in the top 30 according to reputation were also ranked in the top 30 based on outcomes measures. This study suggests that reputation alone does not fully capture a representative snapshot of a program's quality. Rather, the use of multiple quantifiable indicators and attributes unique to programs ought to be given more consideration when assigning ranks to denote program quality. It is advised that the interpretation and subsequent use of program rankings be met with caution until further studies can rigorously demonstrate best practices for awarding program standings. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

A Diabetes Self-Management Program: 12-Month Outcome Sustainability From a Nonreinforced Pragmatic Trial.

PubMed

Lorig, Kate; Ritter, Philip L; Turner, Ralph M; English, Kathleen; Laurent, Diana D; Greenberg, Jay

2016-12-15

Diabetes self-management education has been shown to be effective in controlled trials. The 6-week Better Choices, Better Health-Diabetes (BCBH-D) self-management program was also associated with an improvement in health outcomes in a 6-month translation study. The objective of this study was to determine whether a national translation of the BCBH-D self-management program, offered both Web-based and face-to-face, was associated with improvements in health outcomes (including HbA1c) and health behaviors (including recommended medical tests) 1 year after intervention. Web-based programs were administered nationally, whereas face-to-face workshops took place in Atlanta, Indianapolis, and St Louis. Self-report questionnaires were either Web-based or administered by mail, at baseline and 1 year, and collected health and health-behavior measures. HbA1c blood samples were collected via mailed kits. A previous 6-month study found statistically significant improvements in 13 of 14 outcome measures, including HbA1c. For this study, paired t test compared baseline with 1-year outcomes. Subgroup analyses determined whether participants with specific conditions improved (high HbA1c, depression, hypoglycemia, nonadherence to medication, no aerobic exercise). The percentage of participants with improvements in effect size of at least 0.4 in at least 1 of the 5 measures was calculated. A total of 857 participants with 1-year data (69.7% of baseline participants) demonstrated statistically significant 1-year improvements in 13 of 15 outcome measures; 79.9% (685/857) of participants showed improvements in effect size of 0.4 or greater in at least 1 of the 5 criterial measures. Participants had small but significant benefits in multiple measures. Improvements previously noted at 6 months were maintained or amplified at 1 year. ©Kate Lorig, Philip L Ritter, Ralph M Turner, Kathleen English, Diana D Laurent, Jay Greenberg. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.12.2016.

An overview of animal models of pain: disease models and outcome measures

PubMed Central

Gregory, N; Harris, AL; Robinson, CR; Dougherty, PM; Fuchs, PN; Sluka, KA

2013-01-01

Pain is ultimately a perceptual phenomenon. It is built from information gathered by specialized pain receptors in tissue, modified by spinal and supraspinal mechanisms, and integrated into a discrete sensory experience with an emotional valence in the brain. Because of this, studying intact animals allows the multidimensional nature of pain to be examined. A number of animal models have been developed, reflecting observations that pain phenotypes are mediated by distinct mechanisms. Animal models of pain are designed to mimic distinct clinical diseases to better evaluate underlying mechanisms and potential treatments. Outcome measures are designed to measure multiple parts of the pain experience including reflexive hyperalgesia measures, sensory and affective dimensions of pain and impact of pain on function and quality of life. In this review we discuss the common methods used for inducing each of the pain phenotypes related to clinical pain syndromes, as well as the main behavioral tests for assessing pain in each model. PMID:24035349

Spatial path models with multiple indicators and multiple causes: mental health in US counties.

PubMed

Congdon, Peter

2011-06-01

This paper considers a structural model for the impact on area mental health outcomes (poor mental health, suicide) of spatially structured latent constructs: deprivation, social capital, social fragmentation and rurality. These constructs are measured by multiple observed effect indicators, with the constructs allowed to be correlated both between and within areas. However, in the scheme developed here, particular latent constructs may also be influenced by known variables, or, via path sequences, by other constructs, possibly nonlinearly. For example, area social capital may be measured by effect indicators (e.g. associational density, charitable activity), but influenced as causes by other constructs (e.g. area deprivation), and by observed features of the socio-ethnic structure of areas. A model incorporating these features is applied to suicide mortality and the prevalence of poor mental health in 3141 US counties, which are related to the latent spatial constructs and to observed variables (e.g. county ethnic mix). Copyright © 2011 Elsevier Ltd. All rights reserved.

Challenges and strategies in applying performance measurement to federal public health programs.

PubMed

DeGroff, Amy; Schooley, Michael; Chapel, Thomas; Poister, Theodore H

2010-11-01

Performance measurement is widely accepted in public health as an important management tool supporting program improvement and accountability. However, several challenges impede developing and implementing performance measurement systems at the federal level, including the complexity of public health problems that reflect multiple determinants and involve outcomes that may take years to achieve, the decentralized and networked nature of public health program implementation, and the lack of reliable and consistent data sources and other issues related to measurement. All three of these challenges hinder the ability to attribute program results to specific public health program efforts. The purpose of this paper is to explore these issues in detail and offer potential solutions that support the development of robust and practical performance measures to meet the needs for program improvement and accountability. Adapting performance measurement to public health programs is both an evolving science and art. Through the strategies presented here, appropriate systems can be developed and monitored to support the production of meaningful data that will inform effective decision making at multiple levels. Published by Elsevier Ltd.

Setting the vision: applied patient-reported outcomes and smart, connected digital healthcare systems to improve patient-centered outcomes prediction in critical illness.

PubMed

Wysham, Nicholas G; Abernethy, Amy P; Cox, Christopher E

2014-10-01

Prediction models in critical illness are generally limited to short-term mortality and uncommonly include patient-centered outcomes. Current outcome prediction tools are also insensitive to individual context or evolution in healthcare practice, potentially limiting their value over time. Improved prognostication of patient-centered outcomes in critical illness could enhance decision-making quality in the ICU. Patient-reported outcomes have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. The learning health system is an emerging ideal characterized by integration of multiple data sources into a smart and interconnected health information technology infrastructure with the goal of rapidly optimizing patient care. We propose a vision of a smart, interconnected learning health system with integrated electronic patient-reported outcomes to optimize patient-centered care, including critical care outcome prediction. A learning health system infrastructure integrating electronic patient-reported outcomes may aid in the management of critical illness-associated conditions and yield tools to improve prognostication of patient-centered outcomes in critical illness.

Effects of Pilates-Based Core Stability Training in Ambulant People With Multiple Sclerosis: Multicenter, Assessor-Blinded, Randomized Controlled Trial.

PubMed

Fox, Esther E; Hough, Alan D; Creanor, Siobhan; Gear, Margaret; Freeman, Jennifer A

2016-08-01

Pilates exercise is often undertaken by people with multiple sclerosis (MS) who have balance and mobility difficulties. The primary aim of the study was to compare the effects of 12 weeks of Pilates exercises with relaxation on balance and mobility. Secondary aims were: (1) to compare standardized exercises with relaxation and (2) to compare Pilates exercises with standardized exercises. A multicenter, assessor-blinded, randomized controlled trial was conducted. Participants with Expanded Disability Status Scale scores of 4.0 to 6.5 were randomly allocated to groups receiving 12 weeks of Pilates exercises, standardized exercises, or relaxation. Assessments were undertaken at baseline and weeks 12 and 16 (primary outcome measure: 10-Meter Timed Walk Test [10MTW]). One hundred participants (mean age=54 years, 74% female) were randomized to study groups. Six participants relapsed (withdrew from the study), leaving 94 participants for intention-to-treat analysis. There was no significant difference in mean 10MTW measurements between the Pilates and relaxation groups. At 12 weeks, there was a mean reduction of 4.2 seconds for the standardized exercise group compared with the relaxation group (95% confidence interval [relaxation group minus standardized exercise group measurements]=0.0, 8.4) and a mean reduction of 3.7 seconds for the Pilates group compared with the standardized exercise group (95% confidence interval [Pilates group minus standardized exercise group measurements]=-0.4 to 7.8). At 16 weeks, mean 10MTW times for the standardized exercise group remained quicker than those for the Pilates and relaxation groups, although the differences were nonsignificant. There were no significant differences between the Pilates and relaxation groups for any secondary outcome measure. In this study, therapists were limited to a standardized basket of exercises that may have affected the study outcomes. Furthermore, choosing measures such as posturography to assess balance, accelerometry to assess walking, or a specific trunk assessment scale might have been more responsive in detecting changes in outcome. Participants did not improve significantly, either in the short term or at the 4-week follow-up, on the 10MTW after 12 weeks of Pilates exercises compared with 12 weeks of relaxation. © 2016 American Physical Therapy Association.

Cost-Effectiveness and Cost-Utility of Internet-Based Computer Tailoring for Smoking Cessation

PubMed Central

Evers, Silvia MAA; de Vries, Hein; Hoving, Ciska

2013-01-01

Background Although effective smoking cessation interventions exist, information is limited about their cost-effectiveness and cost-utility. Objective To assess the cost-effectiveness and cost-utility of an Internet-based multiple computer-tailored smoking cessation program and tailored counseling by practice nurses working in Dutch general practices compared with an Internet-based multiple computer-tailored program only and care as usual. Methods The economic evaluation was embedded in a randomized controlled trial, for which 91 practice nurses recruited 414 eligible smokers. Smokers were randomized to receive multiple tailoring and counseling (n=163), multiple tailoring only (n=132), or usual care (n=119). Self-reported cost and quality of life were assessed during a 12-month follow-up period. Prolonged abstinence and 24-hour and 7-day point prevalence abstinence were assessed at 12-month follow-up. The trial-based economic evaluation was conducted from a societal perspective. Uncertainty was accounted for by bootstrapping (1000 times) and sensitivity analyses. Results No significant differences were found between the intervention arms with regard to baseline characteristics or effects on abstinence, quality of life, and addiction level. However, participants in the multiple tailoring and counseling group reported significantly more annual health care–related costs than participants in the usual care group. Cost-effectiveness analysis, using prolonged abstinence as the outcome measure, showed that the mere multiple computer-tailored program had the highest probability of being cost-effective. Compared with usual care, in this group €5100 had to be paid for each additional abstinent participant. With regard to cost-utility analyses, using quality of life as the outcome measure, usual care was probably most efficient. Conclusions To our knowledge, this was the first study to determine the cost-effectiveness and cost-utility of an Internet-based smoking cessation program with and without counseling by a practice nurse. Although the Internet-based multiple computer-tailored program seemed to be the most cost-effective treatment, the cost-utility was probably highest for care as usual. However, to ease the interpretation of cost-effectiveness results, future research should aim at identifying an acceptable cutoff point for the willingness to pay per abstinent participant. PMID:23491820

Individual and Neighborhood Stressors, Air Pollution and Cardiovascular Disease.

PubMed

Hazlehurst, Marnie F; Nurius, Paula S; Hajat, Anjum

2018-03-08

Psychosocial and environmental stress exposures across the life course have been shown to be relevant in the development of cardiovascular disease (CVD). Assessing more than one stressor from different domains (e.g., individual and neighborhood) and across the life course moves us towards a more integrated picture of how stress affects health and well-being. Furthermore, these individual and neighborhood psychosocial stressors act on biologic pathways, including immune function and inflammatory response, which are also impacted by ubiquitous environmental exposures such as air pollution. The objective of this study is to evaluate the interaction between psychosocial stressors, at both the individual and neighborhood level, and air pollution on CVD. This study used data from the 2009-2011 Behavioral Risk Factor Surveillance System (BRFSS) from Washington State. Adverse childhood experiences (ACEs) measured at the individual level, and neighborhood deprivation index (NDI) measured at the zip code level, were the psychosocial stressors of interest. Exposures to three air pollutants-particulate matter (both PM 2.5 and PM 10 ) and nitrogen dioxide (NO₂)-were also calculated at the zip code level. Outcome measures included several self-reported CVD-related health conditions. Both multiplicative and additive interaction quantified using the relative excess risk due to interaction (RERI), were evaluated. This study included 32,151 participants in 502 unique zip codes. Multiplicative and positive additive interactions were observed between ACEs and PM 10 for diabetes, in models adjusted for NDI. The prevalence of diabetes was 1.58 (95% CI: 1.40, 1.79) times higher among those with both high ACEs and high PM 10 compared to those with low ACEs and low PM 10 ( p -value = 0.04 for interaction on the multiplicative scale). Interaction was also observed between neighborhood-level stressors (NDI) and air pollution (NO₂) for the stroke and diabetes outcomes on both multiplicative and additive scales. Modest interaction was observed between NDI and air pollution, supporting prior literature on the importance of neighborhood-level stressors in cardiovascular health and reinforcing the importance of NDI on air pollution health effects. ACEs may exert health effects through selection into disadvantaged neighborhoods and more work is needed to understand the accumulation of risk in multiple domains across the life course.

Multiple-Respondent Anecdotal Assessments: An Analysis of Interrater Agreement and Correspondence with Analogue Assessment Outcomes

ERIC Educational Resources Information Center

Smith, Carla M.; Smith, Richard G.; Dracobly, Joseph D.; Pace, Amy Peterson

2012-01-01

We evaluated interrater agreement across multiple respondents on anecdotal assessments and compared cases in which agreement was obtained with outcomes of functional analyses. Experiment 1 evaluated agreement among multiple respondents on the function of problem behavior for 27 individuals across 42 target behaviors using the Motivation Assessment…

Voxelwise multivariate analysis of multimodality magnetic resonance imaging.

PubMed

Naylor, Melissa G; Cardenas, Valerie A; Tosun, Duygu; Schuff, Norbert; Weiner, Michael; Schwartzman, Armin

2014-03-01

Most brain magnetic resonance imaging (MRI) studies concentrate on a single MRI contrast or modality, frequently structural MRI. By performing an integrated analysis of several modalities, such as structural, perfusion-weighted, and diffusion-weighted MRI, new insights may be attained to better understand the underlying processes of brain diseases. We compare two voxelwise approaches: (1) fitting multiple univariate models, one for each outcome and then adjusting for multiple comparisons among the outcomes and (2) fitting a multivariate model. In both cases, adjustment for multiple comparisons is performed over all voxels jointly to account for the search over the brain. The multivariate model is able to account for the multiple comparisons over outcomes without assuming independence because the covariance structure between modalities is estimated. Simulations show that the multivariate approach is more powerful when the outcomes are correlated and, even when the outcomes are independent, the multivariate approach is just as powerful or more powerful when at least two outcomes are dependent on predictors in the model. However, multiple univariate regressions with Bonferroni correction remain a desirable alternative in some circumstances. To illustrate the power of each approach, we analyze a case control study of Alzheimer's disease, in which data from three MRI modalities are available. Copyright © 2013 Wiley Periodicals, Inc.

Outcomes important to burns patients during scar management and how they compare to the concepts captured in burn-specific patient reported outcome measures.

PubMed

Jones, Laura L; Calvert, Melanie; Moiemen, Naiem; Deeks, Jonathan J; Bishop, Jonathan; Kinghorn, Philip; Mathers, Jonathan

2017-12-01

Pressure garment therapy (PGT) is an established treatment for the prevention and treatment of hypertrophic scarring; however, there is limited evidence for its effectiveness. Burn survivors often experience multiple issues many of which are not adequately captured in current PGT trial measures. To assess the effectiveness of PGT it is important to understand what outcomes matter to patients and to consider whether patient-reported outcome measures (PROMs) can be used to ascertain the effect of treatments on patients' health-related quality of life. This study aimed to (a) understand the priorities and perspectives of adult burns patients and the parents of burns patients who have experienced PGT via in-depth qualitative data, and (b) compare these with the concepts captured within burn-specific PROMs. We undertook 40 semi-structured interviews with adults and parents of paediatric and adolescent burns patients who had experienced PGT to explore their priorities and perspectives on scar management. Interviews were audio-recorded, transcribed and thematically analysed. The outcomes interpreted within the interview data were then mapped against the concepts captured within burn-specific PROMs currently in the literature. Eight core outcome domains were identified as important to adult patients and parents: (1) scar characteristics and appearance, (2) movement and function, (3) scar sensation, (4) psychological distress, adjustments and a sense of normality, (5) body image and confidence, (6) engagement in activities, (7) impact on relationships, and (8) treatment burden. The outcome domains presented reflect a complex holistic patient experience of scar management and treatments such as PGT. Some currently available PROMs do capture the concepts described here, although none assess psychological adjustments and attainment of a sense of normality following burn injury. The routine use of PROMs that represent patient experience and their relative contribution to trial outcome assessment versus clinical measures is now a matter for further research and debate. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Utility of a patient-reported outcome in measuring functional impairment during autologous stem cell transplant in patients with multiple myeloma.

PubMed

Shah, Nina; Shi, Qiuling; Giralt, Sergio; Williams, Loretta; Bashir, Qaiser; Qazilbash, Muzaffar; Champlin, Richard E; Cleeland, Charles S; Wang, Xin Shelley

2018-04-01

We aimed to determine the utility of a patient-reported outcome (PRO) as it relates to patient performed testing (PPT) for measuring functional status in multiple myeloma patients after autologous hematopoietic stem cell transplantation (auto-HCT). Symptom interference on walking (a PRO) was measured by the MD Anderson Symptom Inventory (MDASI). PPT was assessed via 6-min walk test (6MWT). Mixed effects modeling was used to examine (1) the longitudinal relationship between the MDASI score and 6MWT distance and (2) the MDASI scores between patients who did or did not complete the 6WMT. Receiver operating characteristic (ROC) curve analysis was performed to quantify the construct validity of the PRO by differentiating performance status. Seventy-nine patients were included. Mean 6MWT distance significantly correlated with MDASI-walking interference score (PRO) over the first month of auto-HCT (est = 6.09, p = 0.006). There was a significantly higher completion rate for MDASI versus 6MWT at each time point (p < 0.01). Patients who completed the 6MWT reported less interference on walking during the study period (est = 1.61, p < 0.0001). Finally, the PRO demonstrated significant construct validity for measuring functioning status with MDASI-walking against ECOG-PS as the anchor (AUC = 0.77, 95% CI 0.60-0.94, p = 0.003). The PRO of MDASI-walking interference is a valid physical functioning measure, correlating with an objective functional measure (6MWT) in MM patients undergoing auto-HCT. As patients with poorer functional status during therapy are less likely to complete PPT, this PRO may offer a more practical quantitative measure of functioning in patients.

Rationale and design of a randomized controlled, clinical trial investigating a comprehensive exercise stimulus for improving mobility disability outcomes in persons with multiple sclerosis.

PubMed

Motl, Robert W; Pilutti, Lara A; Sandroff, Brian M; Klaren, Rachel; Balantrapu, Swathi; McAuley, Edward; Sosnoff, Jacob J; Fernhall, Bo

2013-05-01

This randomized controlled trial (RCT) examines the effect of a comprehensive exercise training stimulus on physiological function and mobility disability (i.e., problems walking) in individuals with multiple sclerosis (MS) who have walking impairment. This trial will recruit 30 persons with MS across central Illinois who have an Expanded Disability Status Scale score between 4.0 and 6.0, and those persons will be randomized into either the intervention or control arm of the study; the participants will not be blinded regarding group assignment. The intervention will incorporate equal amounts of aerobic, resistance, and balance modes of training delivered 3 times/week with a gradual progression of duration and intensity across a 6-month period. The control will involve stretching along with minimal muscle strengthening stimuli and will be delivered on the same frequency and duration. The primary outcomes will be clinical, kinematic, patient-rated, and physiological measures of mobility disability. The secondary outcomes will be measures of physiological function including aerobic capacity, muscle strength, and balance. This study will lay the foundation for the design of a subsequent Phase II or Phase III RCT by (a) providing effect sizes that can be included in a power analysis for sample size estimation and (b) investigating whether aerobic capacity, muscle strength, and balance are possible factors associated with the beneficial effect of exercise training on walking outcomes. Taken as a whole, the proposed study and our subsequent research agenda has the potential for advancing the management of mobility disability using exercise training in the 2nd stage of MS. Copyright © 2013 Elsevier Inc. All rights reserved.

Association between the Number of Injuries Sustained and 12-Month Disability Outcomes: Evidence from the Injury-VIBES Study

PubMed Central

Gabbe, Belinda J.; Simpson, Pam M.; Lyons, Ronan A.; Ameratunga, Shanthi; Harrison, James E.; Derrett, Sarah; Polinder, Suzanne; Davie, Gabrielle; Rivara, Frederick P.

2014-01-01

Objective To determine associations between the number of injuries sustained and three measures of disability 12-months post-injury for hospitalised patients. Methods Data from 27,840 adult (18+ years) participants, hospitalised for injury, were extracted for analysis from the Validating and Improving injury Burden Estimates (Injury-VIBES) Study. Modified Poisson and linear regression analyses were used to estimate relative risks and mean differences, respectively, for a range of outcomes (Glasgow Outcome Scale-Extended, GOS-E; EQ-5D and 12-item Short Form health survey physical and mental component summary scores, PCS-12 and MCS-12) according to the number of injuries sustained, adjusted for age, sex and contributing study. Findings More than half (54%) of patients had an injury to more than one ICD-10 body region and 62% had sustained more than one Global Burden of Disease injury type. The adjusted relative risk of a poor functional recovery (GOS-E<7) and of reporting problems on each of the items of the EQ-5D increased by 5–10% for each additional injury type, or body region, injured. Adjusted mean PCS-12 and MCS-12 scores worsened with each additional injury type, or body region, injured by 1.3–1.5 points and 0.5 points, respectively. Conclusions Consistent and strong relationships exist between the number of injury types and body regions injured and 12-month functional and health status outcomes. Existing composite measures of anatomical injury severity such as the NISS or ISS, which use up to three diagnoses only, may be insufficient for characterising or accounting for multiple injuries in disability studies. Future studies should consider the impact of multiple injuries to avoid under-estimation of injury burden. PMID:25501651

Relevance of individual participant data meta-analysis for studies in obstetrics: delivery versus expectant monitoring for hypertensive disorders of pregnancy.

PubMed

Broekhuijsen, Kim; Bernardes, Thomas; van Baaren, Gert-Jan; Tajik, Parvin; Novikova, Natalia; Thangaratinam, Shakila; Boers, Kim; Koopmans, Corine M; Wallace, Kedra; Shennan, Andrew H; Langenveld, Josje; Groen, Henk; van den Berg, Paul P; Mol, Ben Willem J; Franssen, Maureen T M

2015-08-01

Like many other research subjects in obstetrics, research on immediate delivery versus expectant monitoring for women with hypertensive disorders of pregnancy faces certain challenges when it comes to interpretation and generalisation of the results; relatively rare outcomes are studied, in a clinically heterogeneous population, while the clinical practice in some countries has dictated that studies in term pregnancy were completed before earlier gestational ages could be studied. This has resulted in multiple smaller studies, some studying surrogate outcome measures, with different in- and exclusion criteria, and without enough power for reliable subgroup analyses. All this complicates the generation of definitive answers and implementation of the results into clinical practice. Performing multiple studies and subsequently pooling their results in a meta-analysis can be a way to overcome the difficulties of studying relatively rare outcomes and subgroups with enough power, as well as a solution to reach a final answer on questions involving an uncertain and possibly harmful intervention. However, in the case of the current studies on delivery versus expectant monitoring in women with hypertensive disorders of pregnancy, differences regarding eligibility criteria, outcome measures and subgroup definitions make it difficult to pool their results in an aggregate meta-analysis. Individual patient data meta-analysis (IPDMA) has the potential to overcome these challenges, because it allows for flexibility regarding the choice of endpoints and standardisation of inclusion and exclusion criteria across studies. In addition, it has more statistical power for informative subgroup analyses. We therefore propose an IPDMA on immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy, and advocate the use of IPDMA for research questions in obstetrics that face similar challenges. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The Essential Properties of Yoga Questionnaire (EPYQ): Psychometric Properties.

PubMed

Park, Crystal L; Elwy, A Rani; Maiya, Meghan; Sarkin, Andrew J; Riley, Kristen E; Eisen, Susan V; Gutierrez, Ian; Finkelstein-Fox, Lucy; Lee, Sharon Y; Casteel, Danielle; Braun, Tosca; Groessl, Erik J

2018-03-02

Yoga interventions are heterogeneous and vary along multiple dimensions. These dimensions may affect mental and physical health outcomes in different ways or through different mechanisms. However, most studies of the effects of yoga on health do not adequately describe or quantify the components of the interventions being implemented. This lack of detail prevents researchers from making comparisons across studies and limits our understanding of the relative effects of different aspects of yoga interventions. To address this problem, we developed the Essential Properties of Yoga Questionnaire (EPYQ), which allows researchers to objectively characterize their interventions. We present here the reliability and validity data from the final phases of this measure-development project. Analyses identified fourteen key dimensions of yoga interventions measured by the EPYQ: acceptance/compassion, bandhas, body awareness, breathwork, instructor mention of health benefits, individual attention, meditation and mindfulness, mental and emotional awareness, physicality, active postures, restorative postures, social aspects, spirituality, and yoga philosophy. The EPYQ demonstrated good reliability, as assessed by internal consistency and test-retest reliability analysis, and evidence suggests that the EPYQ is a valid measure of multiple dimensions of yoga. The measure is ready for use by clinicians and researchers. Results indicate that, currently, trained objective raters should score interventions to avoid reference frame errors and potential rating bias, but alternative approaches may be developed. The EPYQ will allow researchers to link specific yoga dimensions to identifiable health outcomes and optimize the design of yoga interventions for specific conditions.

[Rehabilitation outcomes of terror victims with multiple trauma: the experience in Hadassah University Hospital 2000-2004].

PubMed

Meiner, Zeev; Tuchner, Maya; Shiri, Shimon; Tsenter, Jeanna; Shochina, Mara; Shoshan, Yigal; Katz-Leurer, Michal; Schwartz, Isabella

2008-11-01

From late September 2000 until 2005, the State of Israel was attacked by continuing acts of terrorism known as the Al Aqsa Intifada. During this period the number of terror victims treated in rehabilitation facilities has escalated significantly. The city of Jerusalem has a unique place in the heart of the Israel-Palestinian conflict and, therefore, almost 20% of national atrocities have been carried out in Jerusalem. Between September.2000 and September 2004, 72 terror victims were treated in the department of rehabilitation in Hadassah University Hospital. Among them, 47 (65%) suffered from multiple trauma without CNS involvment, 19 (26%) suffered from traumatic brain injury and 6 (8%) suffered from spinal cord injury. The rehabilitation outcomes of terror victims was compared to the rehabilitation outcomes of non-terror multiple trauma patients treated in the same rehabilitation facility over the same period. The rehabilitation outcomes were evaluted using the following parameters: length of hospitalization (LOH) in acute care departments, inpatient and outpatient rehabilitation departments, functional outcome (Functional Independence Measurement, FIM), occupational outcome (returning to previous occupation) and psychological outcome (Salomon PTSD questionnaire). The mean LOH of terror victims was 218 +/- 131 days as opposed to 152 +/- 114 days for the non-terror group (p < 0.01). The difference between FIM value at entry and discharge (delta FIM) was significantlly higher in terror victims as compared to controls (41.1 +/- 21.6 vs. 30.8 +/- 21.8, p = 0.002). The rate of PTSD was higher among terror victims than non-terror control (40.9% vs. 24.2%, p = 0.04). The rate of returning to previous occupation was similar between terror and non-terror victims (53% vs. 46.9% respectively). Long term study showed that terror victims still suffer from lower quality of life and life satisfaction 2 years after the insult. In summary, terror victims spent longer periods in rehabilitation and regained most of the Activities of Daily Living (ADL) functions similar to the non-terror group. In spite of the higher rate of PTSD, terror victims succeeded in returning to their previous occupation similar to the non-terror group.

Robot-guided ankle sensorimotor rehabilitation of patients with multiple sclerosis.

PubMed

Lee, Yunju; Chen, Kai; Ren, Yupeng; Son, Jongsang; Cohen, Bruce A; Sliwa, James A; Zhang, Li-Qun

2017-01-01

People with multiple sclerosis (MS) often develop symptoms including muscle weakness, spasticity, imbalance, and sensory loss in the lower limbs, especially at the ankle, which result in impaired balance and locomotion and increased risk of falls. Rehabilitation strategies that improve ankle function may improve mobility and safety of ambulation in patients with MS. This pilot study investigated effectiveness of a robot-guided ankle passive-active movement training in reducing motor and sensory impairments and improving balance and gait functions. Seven patients with MS participated in combined passive stretching and active movement training using an ankle rehabilitation robot. Six of the patients finished robotic training 3 sessions per week over 6 weeks for a total of 18 sessions. Biomechanical and clinical outcome evaluations were done before and after the 6-week treatment, and at a follow-up six weeks afterwards. After six-week ankle sensorimotor training, there were increases in active range of motion in dorsiflexion, dorsiflexor and plantar flexor muscle strength, and balance and locomotion (p<0.05). Proprioception acuity showed a trend of improvement. Improvements in four biomechanical outcome measures and two of the clinical outcome measures were maintained at the 6-week follow-up. The study showed the six-week training duration was appropriate to see improvement of range of motion and strength for MS patients with ankle impairment. Robot-guided ankle training is potentially a useful therapeutic intervention to improve mobility in patients with MS. Copyright © 2016 Elsevier B.V. All rights reserved.

A Randomized Educational Intervention Trial to Determine the Effect of Online Education on the Quality of Resident-Delivered Care.

PubMed

Dolan, Brigid M; Yialamas, Maria A; McMahon, Graham T

2015-09-01

There is limited research on whether online formative self-assessment and learning can change the behavior of medical professionals. We sought to determine if an adaptive longitudinal online curriculum in bone health would improve resident physicians' knowledge, and change their behavior regarding prevention of fragility fractures in women. We used a randomized control trial design in which 50 internal medicine resident physicians at a large academic practice were randomized to either receive a standard curriculum in bone health care alone, or to receive it augmented with an adaptive, longitudinal, online formative self-assessment curriculum delivered via multiple-choice questions. Outcomes were assessed 10 months after the start of the intervention. Knowledge outcomes were measured by a multiple-choice question examination. Clinical outcomes were measured by chart review, including bone density screening rate, calculation of the fracture risk assessment tool (FRAX) score, and rate of appropriate bisphosphonate prescription. Compared to the control group, residents participating in the intervention had higher scores on the knowledge test at the end of the study. Bone density screening rates and appropriate use of bisphosphonates were significantly higher in the intervention group compared with the control group. FRAX score reporting did not differ between the groups. Residents participating in a novel adaptive online curriculum outperformed peers in knowledge of fragility fracture prevention and care practices to prevent fracture. Online adaptive education can change behavior to improve patient care.

A Randomized Educational Intervention Trial to Determine the Effect of Online Education on the Quality of Resident-Delivered Care

PubMed Central

Dolan, Brigid M.; Yialamas, Maria A.; McMahon, Graham T.

2015-01-01

Background There is limited research on whether online formative self-assessment and learning can change the behavior of medical professionals. Objective We sought to determine if an adaptive longitudinal online curriculum in bone health would improve resident physicians' knowledge, and change their behavior regarding prevention of fragility fractures in women. Methods We used a randomized control trial design in which 50 internal medicine resident physicians at a large academic practice were randomized to either receive a standard curriculum in bone health care alone, or to receive it augmented with an adaptive, longitudinal, online formative self-assessment curriculum delivered via multiple-choice questions. Outcomes were assessed 10 months after the start of the intervention. Knowledge outcomes were measured by a multiple-choice question examination. Clinical outcomes were measured by chart review, including bone density screening rate, calculation of the fracture risk assessment tool (FRAX) score, and rate of appropriate bisphosphonate prescription. Results Compared to the control group, residents participating in the intervention had higher scores on the knowledge test at the end of the study. Bone density screening rates and appropriate use of bisphosphonates were significantly higher in the intervention group compared with the control group. FRAX score reporting did not differ between the groups. Conclusions Residents participating in a novel adaptive online curriculum outperformed peers in knowledge of fragility fracture prevention and care practices to prevent fracture. Online adaptive education can change behavior to improve patient care. PMID:26457142

Comparison of the efficacy of saline, local anesthetics, and steroids in epidural and facet joint injections for the management of spinal pain: A systematic review of randomized controlled trials

PubMed Central

Manchikanti, Laxmaiah; Nampiaparampil, Devi E.; Manchikanti, Kavita N.; Falco, Frank J.E.; Singh, Vijay; Benyamin, Ramsin M.; Kaye, Alan D.; Sehgal, Nalini; Soin, Amol; Simopoulos, Thomas T.; Bakshi, Sanjay; Gharibo, Christopher G.; Gilligan, Christopher J.; Hirsch, Joshua A.

2015-01-01

Background: The efficacy of epidural and facet joint injections has been assessed utilizing multiple solutions including saline, local anesthetic, steroids, and others. The responses to these various solutions have been variable and have not been systematically assessed with long-term follow-ups. Methods: Randomized trials utilizing a true active control design were included. The primary outcome measure was pain relief and the secondary outcome measure was functional improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the criteria developed by the American Society of Interventional Pain Physicians (ASIPP) for assessing interventional techniques. An evidence analysis was conducted based on the qualitative level of evidence (Level I to IV). Results: A total of 31 trials met the inclusion criteria. There was Level I evidence that local anesthetic with steroids was effective in managing chronic spinal pain based on multiple high-quality randomized controlled trials. The evidence also showed that local anesthetic with steroids and local anesthetic alone were equally effective except in disc herniation, where the superiority of local anesthetic with steroids was demonstrated over local anesthetic alone. Conclusion: This systematic review showed equal efficacy for local anesthetic with steroids and local anesthetic alone in multiple spinal conditions except for disc herniation where the superiority of local anesthetic with steroids was seen over local anesthetic alone. PMID:26005584

A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis.

PubMed

Al-Smadi, J; Warke, K; Wilson, I; Cramp, A F L; Noble, G; Walsh, D M; Lowe-Strong, A S

2003-11-01

To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) upon low back pain (LBP) in people with multiple sclerosis (MS). A randomized double-blind placebo controlled clinical pilot study. Fifteen people with MS were recruited and randomly allocated to one of the following groups under double blind conditions (n = 5 per group): TENS 1 (4 Hz, 200 micros), TENS 2 (110 Hz, 200 micros), placebo TENS. Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up. The following outcome measures were taken at weeks 1, 6, and 10: visual analogue scale (VAS) (for current LBP, right leg pain, left leg pain); Leeds Multiple Sclerosis Quality of Life Questionnaire; Roland Morris Disability Questionnaire; Short Form-36 (SF-36) Version 1; and the McGill Pain Questionnaire (MPQ). VAS for current LBP, right and left leg pain were also taken before and after treatment, and once a week during the follow-up period. Analysis showed no statistically significant effects for any of the data. However, both active treatment groups showed a trend of improvement in the majority of the outcome measures. Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant. Further work in this area is warranted and should include a larger number of participants in the form of a randomized controlled clinical trial to determine the efficacy of this modality.

Dimensions of Poverty and Health Outcomes Among People Living with HIV Infection: Limited Resources and Competing Needs.

PubMed

Kalichman, Seth C; Hernandez, Dominica; Kegler, Christopher; Cherry, Chauncey; Kalichman, Moira O; Grebler, Tamar

2015-08-01

HIV infection is concentrated in populations living in poverty. We examined the overlapping and independent effects of multiple poverty indicators on HIV-related health status. Because substance use can create competing survival needs when resources are limited, we also sought to objectively measure expenditures on food relative to alcohol and tobacco products. To achieve these aims, 459 men and 212 women living with HIV infection in Atlanta, GA completed measures of socio-demographic and heath characteristics as well as multiple indicators of poverty including housing stability, transportation, food insecurity, and substance use. Participants were given a $30 grocery gift card for their participation and we collected receipts which were coded for alcohol (beer, wine, liquors) and tobacco purchases. Results showed that participants with unsuppressed HIV replication were significantly more likely to experience multiple indicators of poverty. In addition, one in four participants purchased alcohol or tobacco products with their gift cards, with as much as one-fourth of money spent on these products. A multivariable logistic regression model showed that food insecurity was independently associated with unsuppressed HIV, and purchasing alcohol or tobacco products did not moderate this association. Results confirm previous research to show the primacy of food insecurity in relation to HIV-related health outcomes. Competing survival needs, including addictive substances, should be addressed in programs that aim to alleviate poverty to enhance the health and well-being of people with HIV infection.

Effectiveness of computerized clinical decision support systems for asthma and chronic obstructive pulmonary disease in primary care: a systematic review.

PubMed

Fathima, Mariam; Peiris, David; Naik-Panvelkar, Pradnya; Saini, Bandana; Armour, Carol Lyn

2014-12-02

The use of computerized clinical decision support systems may improve the diagnosis and ongoing management of chronic diseases, which requires recurrent visits to multiple health professionals, disease and medication monitoring and modification of patient behavior. The aim of this review was to systematically review randomized controlled trials evaluating the effectiveness of computerized clinical decision systems (CCDSS) in the care of people with asthma and COPD. Randomized controlled trials published between 2003 and 2013 were searched using multiple electronic databases Medline, EMBASE, CINAHL, IPA, Informit, PsychINFO, Compendex, and Cochrane Clinical Controlled Trials Register databases. To be included, RCTs had to evaluate the role of the CCDSSs for asthma and/or COPD in primary care. Nineteen studies representing 16 RCTs met our inclusion criteria. The majority of the trials were conducted in patients with asthma. Study quality was generally high. Meta-analysis was not conducted because of methodological and clinical heterogeneity. The use of CCDSS improved asthma and COPD care in 14 of the 19 studies reviewed (74%). Nine of the nineteen studies showed statistically significant (p < 0.05) improvement in the primary outcomes measured. The majority of the studies evaluated health care process measures as their primary outcomes (10/19). Evidence supports the effectiveness of CCDSS in the care of people with asthma. However there is very little information of its use in COPD care. Although there is considerable improvement in the health care process measures and clinical outcomes through the use of CCDSSs, its effects on user workload and efficiency, safety, costs of care, provider and patient satisfaction remain understudied.

Multiple sclerosis and extract of cannabis: results of the MUSEC trial.

PubMed

Zajicek, John Peter; Hobart, Jeremy C; Slade, Anita; Barnes, David; Mattison, Paul G

2012-11-01

Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies. Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N=144) or placebo (N=135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability. The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs. 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p=0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings. The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed. NCT00552604.

Patient-reported outcomes in drug development for hematology.

PubMed

Acquadro, Catherine; Regnault, Antoine

2015-01-01

Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of treatment from a patient's view. However, PROs will only be considered adequate if the assessment is well-defined and reliable. In 2009, the FDA has issued a guidance, which defines good measurement principles to consider for PRO measures intended to give evidence of treatment benefit in drug development. In hematologic clinical trials, when applied rigorously, they may be used to evaluate overall treatment effectiveness, treatment toxicity, and quality of patient's well-being at short-term and long-term after treatment from a patient's perspective. In situations in which multiple treatment options exist with similar survival outcome or if a new therapeutic strategy needs to be evaluated, the inclusion of PROs as an endpoint can provide additional data and help in clinical decision making. Given the diversity of the hematological field, the approach to measurement needs to be tailored for each specific situation. The importance of PROs in hematologic diseases has been highlighted in a number of international recommendations. In addition, new perspectives in the regulatory field will enhance the inclusion of PRO endpoints in clinical trials in hematology, allowing the voice of the patients with hematologic diseases to be taken into greater consideration in the development of new drugs. © 2015 by The American Society of Hematology. All rights reserved.

A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress.

PubMed

Bluth, Karen; Roberson, Patricia N E; Gaylord, Susan A

2015-01-01

In this pilot study, we sought to investigate the effects of a mindfulness intervention for adolescents on a community sample of teens. Specifically, we explored the effects of mindfulness training on emotional well-being outcomes. Also, we examined the relationship between mindfulness and self-compassion at baseline-predicted outcome measures. This design was a pre-/post-pilot intervention study. Paired t-tests were conducted to examine change in outcome measures before and after the mindfulness intervention. Multiple regression was also conducted to investigate the influence of baseline mindfulness and self-compassion on outcome measures. The study took place after school in a classroom at a local university. Overall 28 adolescents age 10-18 years from two different cohorts participated in this study. Learning to BREATHE, a mindfulness curriculum designed specifically for adolescents and taught in six 1.5h sessions, was implemented. The outcome measures, life satisfaction and perceived stress, were included in an online survey before and after the mindfulness intervention. Results indicated that mindfulness, self-compassion, perceived stress, and life satisfaction improved from pre-intervention to post-intervention. Further, self-compassion (taught within the mindfulness intervention) was negatively related to perceived stress post-intervention while controlling for baseline stress. These findings suggest that mindfulness may be an effective intervention for improving indicators of emotional well-being among an adolescent population. Additionally, self-compassion may be a pathway through which youth can lower stress. Future research should examine self-compassion as a potential factor in promoting emotional well-being. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluating nursing administration instruments.

PubMed

Huber, D L; Maas, M; McCloskey, J; Scherb, C A; Goode, C J; Watson, C

2000-05-01

To identify and evaluate available measures that can be used to examine the effects of management innovations in five important areas: autonomy, conflict, job satisfaction, leadership, and organizational climate. Management interventions target the context in which care is delivered and through which evidence for practice diffuses. These innovations need to be evaluated for their effects on desired outcomes. However, busy nurses may not have the time to locate, evaluate, and select instruments to measure expected nursing administration outcomes without research-based guidance. Multiple and complex important contextual variables need psychometrically sound and easy-to-use measurement instruments identified for use in both practice and research. An expert focus group consensus methodology was used in this evaluation research to review available instruments in the five areas and evaluate which of these instruments are psychometrically sound and easy to use in the practice setting. The result is a portfolio of measures, clustered by concept and displayed on a spreadsheet. Retrieval information is provided. The portfolio includes the expert consensus judgment as well as useful descriptive information. The research reported here identifies psychometrically sound and easy-to-use instruments for measuring five key variables to be included in a portfolio. The results of this study can be used as a beginning for saving time in instrument selection and as an aid for determining the best instrument for measuring outcomes from a clinical or management intervention.

The effect of alcohol and red wine consumption on clinical and MRI outcomes in multiple sclerosis.

PubMed

Diaz-Cruz, Camilo; Chua, Alicia S; Malik, Muhammad Taimur; Kaplan, Tamara; Glanz, Bonnie I; Egorova, Svetlana; Guttmann, Charles R G; Bakshi, Rohit; Weiner, Howard L; Healy, Brian C; Chitnis, Tanuja

2017-10-01

Alcohol and in particular red wine have both immunomodulatory and neuroprotective properties, and may exert an effect on the disease course of multiple sclerosis (MS). To assess the association between alcohol and red wine consumption and MS course. MS patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital (CLIMB) who completed a self-administered questionnaire about their past year drinking habits at a single time point were included in the study. Alcohol and red wine consumption were measured as servings/week. The primary outcome was the Expanded Disability Status Scale (EDSS) at the time of the questionnaire. Secondary clinical outcomes were the Multiple Sclerosis Severity Score (MSSS) and number of relapses in the year before the questionnaire. Secondary MRI outcomes included brain parenchymal fraction and T2 hyperintense lesion volume (T2LV). Appropriate regression models were used to test the association of alcohol and red wine intake on clinical and MRI outcomes. All analyses were controlled for sex, age, body mass index, disease phenotype (relapsing vs. progressive), the proportion of time on disease modifying therapy during the previous year, smoking exposure, and disease duration. In the models for the MRI outcomes, analyses were also adjusted for acquisition protocol. 923 patients (74% females, mean age 47 ± 11 years, mean disease duration 14 ± 9 years) were included in the analysis. Compared to abstainers, patients drinking more than 4 drinks per week had a higher likelihood of a lower EDSS score (OR, 0.41; p = 0.0001) and lower MSSS (mean difference, - 1.753; p = 0.002) at the time of the questionnaire. Similarly, patients drinking more than 3 glasses of red wine per week had greater odds of a lower EDSS (OR, 0.49; p = 0.0005) and lower MSSS (mean difference, - 0.705; p = 0.0007) compared to nondrinkers. However, a faster increase in T2LV was observed in patients consuming 1-3 glasses of red wine per week compared to nondrinkers. Higher total alcohol and red wine intake were associated with a lower cross-sectional level of neurologic disability in MS patients but increased T2LV accumulation. Further studies should explore a potential cause-effect neuroprotective relationship, as well as the underlying biological mechanisms. Copyright © 2017 Elsevier B.V. All rights reserved.

Getting the balance right: a randomised controlled trial of physiotherapy and Exercise Interventions for ambulatory people with multiple sclerosis.

PubMed

Coote, Susan; Garrett, Maria; Hogan, Neasa; Larkin, Aidan; Saunders, Jean

2009-07-16

People with Multiple Sclerosis have a life long need for physiotherapy and exercise interventions due to the progressive nature of the disease and their greater risk of the complications of inactivity. The Multiple Sclerosis Society of Ireland run physiotherapy, yoga and exercise classes for their members, however there is little evidence to suggest which form of physical activity optimises outcome for people with the many and varied impairments associated with MS. This is a multi-centre, single blind, block randomised, controlled trial. Participants will be recruited via the ten regional offices of MS Ireland. Telephone screening will establish eligibility and stratification according to the mobility section of the Guys Neurological Disability Scale. Once a block of people of the same strand in the same geographical region have given consent, participants will be randomised. Strand A will concern individuals with MS who walk independently or use one stick to walk outside. Participants will be randomised to yoga, physiotherapy led exercise class, fitness instructor led exercise class or to a control group who don't change their exercise habits.Strand B will concern individuals with MS who walk with bilateral support or a rollator, they may use a wheelchair for longer distance outdoors. Participants will be randomised to 1:1 Physiotherapist led intervention, group intervention led by Physiotherapist, group yoga intervention or a control group who don't change their exercise habits. Participants will be assessed by physiotherapist who is blind to the group allocation at week 1, week 12 (following 10 weeks intervention or control), and at 12 week follow up. The primary outcome measure for both strands is the Multiple Sclerosis Impact Scale. Secondary outcomes are Modified Fatigue Impact Scale, 6 Minute Walk test, and muscle strength measured with hand held dynamometry. Strand B will also use Berg Balance Test and the Modified Ashworth Scale. Confounding variables such as sensation, coordination, proprioception, range of motion and other impairments will be recorded at initial assessment. Data analysis will analyse change in each group, and the differences between groups. Sub group analysis may be performed if sufficient numbers are recruited. ISRCTN77610415.

Assessing learning outcomes and cost effectiveness of an online sleep curriculum for medical students.

PubMed

Bandla, Hari; Franco, Rose A; Simpson, Deborah; Brennan, Kimberly; McKanry, Jennifer; Bragg, Dawn

2012-08-15

Sleep disorders are highly prevalent across all age groups but often remain undiagnosed and untreated, resulting in significant health consequences. To overcome an inadequacy of available curricula and learner and instructor time constraints, this study sought to determine if an online sleep medicine curriculum would achieve equivalent learner outcomes when compared with traditional, classroom-based, face-to-face instruction at equivalent costs. Medical students rotating on a required clinical clerkship received instruction in 4 core clinical sleep-medicine competency domains in 1 of 2 delivery formats: a single 2.5-hour face-to-face workshop or 4 asynchronous e-learning modules. Immediate learning outcomes were assessed in a subsequent clerkship using a multiple-choice examination and standardized patient station, with long-term outcomes assessed through analysis of students' patient write-ups for inclusion of sleep complaints and diagnoses before and after the intervention. Instructional costs by delivery format were tracked. Descriptive and inferential statistical analyses compared learning outcomes and costs by instructional delivery method (face-to-face versus e-learning). Face-to-face learners, compared with online learners, were more satisfied with instruction. Learning outcomes (i.e., multiple-choice examination, standardized patient encounter, patient write-up), as measured by short-term and long-term assessments, were roughly equivalent. Design, delivery, and learner-assessment costs by format were equivalent at the end of 1 year, due to higher ongoing teaching costs associated with face-to-face learning offsetting online development and delivery costs. Because short-term and long-term learner performance outcomes were roughly equivalent, based on delivery method, the cost effectiveness of online learning is an economically and educationally viable instruction platform for clinical clerkships.

Quantifying Genome Editing Outcomes at Endogenous Loci using SMRT Sequencing

PubMed Central

Clark, Joseph; Punjya, Niraj; Sebastiano, Vittorio; Bao, Gang; Porteus, Matthew H

2014-01-01

SUMMARY Targeted genome editing with engineered nucleases has transformed the ability to introduce precise sequence modifications at almost any site within the genome. A major obstacle to probing the efficiency and consequences of genome editing is that no existing method enables the frequency of different editing events to be simultaneously measured across a cell population at any endogenous genomic locus. We have developed a novel method for quantifying individual genome editing outcomes at any site of interest using single molecule real time (SMRT) DNA sequencing. We show that this approach can be applied at various loci, using multiple engineered nuclease platforms including TALENs, RNA guided endonucleases (CRISPR/Cas9), and ZFNs, and in different cell lines to identify conditions and strategies in which the desired engineering outcome has occurred. This approach facilitates the evaluation of new gene editing technologies and permits sensitive quantification of editing outcomes in almost every experimental system used. PMID:24685129

Patient and cycle characteristics predicting high pregnancy rates with single-embryo transfer: an analysis of the Society for Assisted Reproductive Technology outcomes between 2004 and 2013.

PubMed

Mersereau, Jennifer; Stanhiser, Jamie; Coddington, Charles; Jones, Tiffany; Luke, Barbara; Brown, Morton B

2017-11-01

To analyze factors associated with high live birth rate and low multiple birth rate in fresh and frozen-thawed assisted reproductive technology (ART) cycles. Retrospective cohort analysis. Not applicable. The study population included 181,523 women undergoing in vitro fertilization with autologous fresh first cycles, 27,033 with fresh first oocyte donor cycles, 37,658 with fresh second cycles, and 35,446 with frozen-thawed second cycles. None. Live birth rate and multiple birth rate after single-embryo transfer (SET) and double embryo transfer (DET) were measured, in addition to cycle characteristics. In patients with favorable prognostic factors, including younger maternal age, transfer of a blastocyst, and additional embryos cryopreserved, the gain in the live birth rate from SET to DET was approximately 10%-15%; however, the multiple birth rate increased from approximately 2% to greater than 49% in both autologous and donor fresh and frozen-thawed transfer cycles. This study reports a 10%-15% reduction in live birth rate and a 47% decrement in multiple birth rate with SET compared with DET in the setting of favorable patient prognostic factors. Our findings present an opportunity to increase the rate of SET across the United States and thereby reduce the multiple birth rate and its associated poor perinatal outcomes with assisted reproductive technology pregnancies. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Comparing strategies to assess multiple behavior change in behavioral intervention studies.

PubMed

Drake, Bettina F; Quintiliani, Lisa M; Sapp, Amy L; Li, Yi; Harley, Amy E; Emmons, Karen M; Sorensen, Glorian

2013-03-01

Alternatives to individual behavior change methods have been proposed, however, little has been done to investigate how these methods compare. To explore four methods that quantify change in multiple risk behaviors targeting four common behaviors. We utilized data from two cluster-randomized, multiple behavior change trials conducted in two settings: small businesses and health centers. Methods used were: (1) summative; (2) z-score; (3) optimal linear combination; and (4) impact score. In the Small Business study, methods 2 and 3 revealed similar outcomes. However, physical activity did not contribute to method 3. In the Health Centers study, similar results were found with each of the methods. Multivitamin intake contributed significantly more to each of the summary measures than other behaviors. Selection of methods to assess multiple behavior change in intervention trials must consider study design, and the targeted population when determining the appropriate method/s to use.

Prognostic Effect of Low Subcutaneous Adipose Tissue on Survival Outcome in Patients With Multiple Myeloma.

PubMed

Takeoka, Yasunobu; Sakatoku, Kazuki; Miura, Akiko; Yamamura, Ryosuke; Araki, Taku; Seura, Hirotaka; Okamura, Terue; Koh, Hideo; Nakamae, Hirohisa; Hino, Masayuki; Ohta, Kensuke

2016-08-01

Increasing evidence suggests that decreased skeletal muscle mass (sarcopenia) or adipose tissue assessed using computed tomography (CT) predicts negative outcomes in patients with solid tumors. However, the prognostic value of such an assessment in multiple myeloma (MM) remains unknown. Consecutive patients with newly diagnosed symptomatic MM were retrospectively analyzed. The cross-sectional area of skeletal muscles and subcutaneous or visceral adipose tissue was measured using CT. Body composition indexes (skeletal muscle index, subcutaneous adipose tissue index [SAI], and visceral adipose tissue index) were calculated. The association between these indexes and overall survival (OS) was examined. Of 56 evaluable patients, 37 (66%) had sarcopenia. The 2-year OS in patients with SAI < median was 58% compared with 91% in those with SAI ≥ median (P = .006). In multivariate analyses, SAI < median was significantly associated with poor OS (hazard ratio, 4.05; P = .02). Sarcopenia was not associated with OS. The maximum value of the standardized uptake value was significantly higher in patients with SAI < median (P = .02). The findings of this study suggest that low subcutaneous adipose tissue at baseline predicts poor survival outcome in patients with MM. Copyright © 2016 Elsevier Inc. All rights reserved.

Single- or multiple-visit endodontics: which technique results in fewest postoperative problems?

PubMed

Balto, Khaled

2009-01-01

The Cochrane Central Register of Controlled Trials, Medline, Embase, six thesis databases (Networked Digital Library of Theses and Dissertations, Proquest Digital Dissertations, OAIster, Index to Theses, Australian Digital Thesis Program and Dissertation.com) and one conference report database (BIOSIS Previews) were searched. There were no language restrictions. Studies were included if subjects had a noncontributory medical history; underwent nonsurgical root canal treatment during the study; there was comparison between single- and multiple-visit root canal treatment; and if outcome was measured in terms of pain degree or prevalence of flare-up. Data were extracted using a standard data extraction sheet. Because of variations in recorded outcomes and methodological and clinical heterogeneity, a meta-analysis was not carried out, although a qualitative synthesis was presented. Sixteen studies fitted the inclusion criteria in the review, with sample size varying from 60-1012 cases. The prevalence of postoperative pain ranged from 3-58%. The heterogeneity of the included studies was far too great to yield meaningful results from a meta-analysis. Compelling evidence is lacking to indicate any significantly different prevalence of postoperative pain or flare-up following either single- or multiple-visit root canal treatment.

[Long-term results after multiple trauma with ISS ≥ 25. Outcome and predictors of quality of life].

PubMed

Simmel, S; Drisch, S; Haag, S; Bühren, V

2013-09-01

The survival chances of multiple trauma patients have continually improved over the last decades; therefore, it is often not a question of whether a patient survives a severe accident but rather how the patient survives. In a retrospective study 127 patients were questioned regarding quality of life and health and possible influencing factors using the POLO chart an average of 70 months after suffering severe trauma (ISS Ø 35.6). The quality of life of severely injured patients is significantly reduced compared with the normal population even years after the trauma. In addition to four pretraumatic factors (older age, female gender, low education and previous illnesses) four posttraumatic variables (difficulties with authorities/institutions and unemployment as a consequence of the accident, long duration and subjectively inadequate treatment in hospital) were identified that have a negative impact on long-term quality of life. The self-reported quality of life after multiple trauma no longer permanently achieves the original level despite extensive rehabilitation measures. Post-traumatic factors have a greater impact on the long-term quality of life than the injury severity. A long-term care and specialized rehabilitation services are needed to improve outcome further.

Factors related to difficulties with employment in patients with multiple sclerosis: a review of 2002-2011 literature.

PubMed

Schiavolin, Silvia; Leonardi, Matilde; Giovannetti, Ambra M; Antozzi, Carlo; Brambilla, Laura; Confalonieri, Paolo; Mantegazza, Renato; Raggi, Alberto

2013-06-01

We assess the knowledge available on the difficulties experienced by multiple sclerosis (MS) patients in work-related activities. A literature review was carried out using the keywords 'multiple sclerosis' and 'employment' or 'work' through PubMed and EMBASE. Papers reporting patient-derived data on difficulties at work as primary or secondary outcome measures and published in the period 2002-December 2011 were searched. A total of 26 papers were selected, for a total of 32 507 patients (mean age 46.2 years; 42.1% with relapsing-remitting MS). Most papers reported observational studies or cross-sectional surveys focused on health-related quality of life and MS costs. Symptoms more frequently addressed are fatigue, mobility and cognitive impairments. Limited research has been carried out on the working environment. We found a relatively small number of papers published in the last 10 years on the difficulties that patients with MS can experience at work, and this kind of information always appeared as a secondary outcome. In general, it is possible to affirm that MS has a strong impact on patients' employment status, as the mean unemployment rate was 59%. Research on factors promoting maintenance of remunerative employment is required.

Deepening our understanding of quality improvement in Europe (DUQuE): overview of a study of hospital quality management in seven countries

PubMed Central

Secanell, Mariona; Groene, Oliver; Arah, Onyebuchi A.; Lopez, Maria Andrée; Kutryba, Basia; Pfaff, Holger; Klazinga, Niek; Wagner, Cordula; Kristensen, Solvejg; Bartels, Paul Daniel; Garel, Pascal; Bruneau, Charles; Escoval, Ana; França, Margarida; Mora, Nuria; Suñol, Rosa; Klazinga, N; Kringos, DS; Lopez, MA; Secanell, M; Sunol, R; Vallejo, P; Bartels, P; Kristensen, S; Michel, P; Saillour-Glenisson, F; Vlcek, F; Car, M; Jones, S; Klaus, E; Bottaro, S; Garel, P; Saluvan, M; Bruneau, C; Depaigne-Loth, A; Shaw, C; Hammer, A; Ommen, O; Pfaff, H; Groene, O; Botje, D; Wagner, C; Kutaj-Wasikowska, H; Kutryba, B; Escoval, A; Lívio, A; Eiras, M; Franca, M; Leite, I; Almeman, F; Kus, H; Ozturk, K; Mannion, R; Arah, OA; Chow, A; DerSarkissian, M; Thompson, CA; Wang, A; Thompson, A

2014-01-01

Introduction and Objective This paper provides an overview of the DUQuE (Deepening our Understanding of Quality Improvement in Europe) project, the first study across multiple countries of the European Union (EU) to assess relationships between quality management and patient outcomes at EU level. The paper describes the conceptual framework and methods applied, highlighting the novel features of this study. Design DUQuE was designed as a multi-level cross-sectional study with data collection at hospital, pathway, professional and patient level in eight countries. Setting and Participants We aimed to collect data for the assessment of hospital-wide constructs from up to 30 randomly selected hospitals in each country, and additional data at pathway and patient level in 12 of these 30. Main outcome measures A comprehensive conceptual framework was developed to account for the multiple levels that influence hospital performance and patient outcomes. We assessed hospital-specific constructs (organizational culture and professional involvement), clinical pathway constructs (the organization of care processes for acute myocardial infarction, stroke, hip fracture and deliveries), patient-specific processes and outcomes (clinical effectiveness, patient safety and patient experience) and external constructs that could modify hospital quality (external assessment and perceived external pressure). Results Data was gathered from 188 hospitals in 7 participating countries. The overall participation and response rate were between 75% and 100% for the assessed measures. Conclusions This is the first study assessing relation between quality management and patient outcomes at EU level. The study involved a large number of respondents and achieved high response rates. This work will serve to develop guidance in how to assess quality management and makes recommendations on the best ways to improve quality in healthcare for hospital stakeholders, payers, researchers, and policy makers throughout the EU. PMID:24671120

Obstetric hemorrhage and shock management: using the low technology Non-pneumatic Anti-Shock Garment in Nigerian and Egyptian tertiary care facilities.

PubMed

Miller, Suellen; Fathalla, Mohamed M F; Ojengbede, Oladosu A; Camlin, Carol; Mourad-Youssif, Mohammed; Morhason-Bello, Imran O; Galadanci, Hadiza; Nsima, David; Butrick, Elizabeth; Al Hussaini, Tarek; Turan, Janet; Meyer, Carinne; Martin, Hilarie; Mohammed, Aminu I

2010-10-18

Obstetric hemorrhage is the leading cause of maternal mortality globally. The Non-pneumatic Anti-Shock Garment (NASG) is a low-technology, first-aid compression device which, when added to standard hypovolemic shock protocols, may improve outcomes for women with hypovolemic shock secondary to obstetric hemorrhage in tertiary facilities in low-resource settings. This study employed a pre-intervention/intervention design in four facilities in Nigeria and two in Egypt. Primary outcomes were measured mean and median blood loss, severe end-organ failure morbidity (renal failure, pulmonary failure, cardiac failure, or CNS dysfunctions), mortality, and emergency hysterectomy for 1442 women with ≥750 mL blood loss and at least one sign of hemodynamic instability. Comparisons of outcomes by study phase were assessed with rank sum tests, relative risks (RR), number needed to treat for benefit (NNTb), and multiple logistic regression. Women in the NASG phase (n = 835) were in worse condition on study entry, 38.5% with mean arterial pressure <60 mmHg vs. 29.9% in the pre-intervention phase (p = 0.001). Despite this, negative outcomes were significantly reduced in the NASG phase: mean measured blood loss decreased from 444 mL to 240 mL (p < 0.001), maternal mortality decreased from 6.3% to 3.5% (RR 0.56, 95% CI 0.35-0.89), severe morbidities from 3.7% to 0.7% (RR 0.20, 95% CI 0.08-0.50), and emergency hysterectomy from 8.9% to 4.0% (RR 0.44, 0.23-0.86). In multiple logistic regression, there was a 55% reduced odds of mortality during the NASG phase (aOR 0.45, 0.27-0.77). The NNTb to prevent either mortality or severe morbidity was 18 (12-36). Adding the NASG to standard shock and hemorrhage management may significantly improve maternal outcomes from hypovolemic shock secondary to obstetric hemorrhage at tertiary care facilities in low-resource settings.

Children’s dietary reporting accuracy over multiple 24-hour recalls varies by body mass index category

PubMed Central

Baxter, Suzanne Domel; Smith, Albert F.; Nichols, Michele D.; Guinn, Caroline H.; Hardin, James W.

2007-01-01

This secondary analysis investigated the influence of body mass index (BMI) category and sex on reporting accuracy during multiple 24-hour dietary recalls. On three occasions, each of 79 children (40 girls) was observed eating school meals and interviewed the next morning about the previous day’s intake, with ≥ 25 days between any two consecutive occasions for a child. Using age/sex BMI percentiles, we categorized 48 children as healthy weight (≥ 5th percentile <85th), 14 as at risk of overweight (≥ 85th percentile <95th), and 17 as overweight (≥95th percentile). A repeated-measures analysis was conducted for each of five outcomes (number of items observed eaten, number of items reported eaten, omission rate, intrusion rate, total inaccuracy). For items observed, BMI category x trial was marginally significant (P=0.079); over trials, this outcome was stable for healthy-weight children, decreased and stabilized for at-risk-of-overweight children, and was stable and decreased for overweight children. This outcome was greatest for overweight children and least for healthy-weight children (P=0.015). For items reported, no significant effects were found. For omission rate (P=0.028) and intrusion rate (P=0.083), BMI category x trial was significant and marginally significant; over trials, both decreased for healthy-weight children, decreased and stabilized for at-risk-of-overweight children, and increased and stabilized for overweight children. Total inaccuracy decreased slightly over trials (P=0.076); this outcome was greater for boys than for girls (P=0.049). Results suggest that children’s dietary reporting accuracy over multiple recalls varies by BMI category. Validation studies with adequate samples for each BMI category, sex, and race are needed. PMID:17541449

The Relevance of Geriatric Impairments in Patients Starting Dialysis: A Systematic Review

PubMed Central

Wouters, Tom R.; Boereboom, Franciscus T.J.; Bots, Michiel L.; Verhaar, Marianne C.; Hamaker, Marije E.

2016-01-01

Background and objectives With aging of the general population, patients who enter dialysis therapy will more frequently have geriatric impairments and a considerable comorbidity burden. The most vulnerable among these patients might benefit from conservative therapy. Whether assessment of geriatric impairments would contribute to the decision-making process of dialysis initiation is unknown. Design, setting, participants, & measurements A systematic Medline and Embase search was performed on December 1, 2015 to identify studies assessing the association between risk of mortality or hospitalization and one or more geriatric impairments at the start of dialysis therapy, including impairment of cognitive function, mood, performance status or (instrumental) activities of daily living, mobility (including falls), social environment, or nutritional status. Results Twenty-seven studies were identified that assessed one or more geriatric impairments with respect to prognosis. The quality of most studies was moderate. Only seven studies carried out an analysis of elderly patients (≥70 years old). Malnutrition and frailty were systematically assessed, and their relation with mortality was clear. In addition, cognitive impairment and functional outcomes at the initiation of dialysis were related to an increased mortality in most studies. However, not all studies applied systematic assessment tools, thereby potentially missing relevant impairment. None of the studies applied a geriatric assessment across multiple domains. Conclusions Geriatric impairment across multiple domains at dialysis initiation is related to poor outcome. However, information in the elderly is sparse, and a systematic approach of multiple domains with respect to poor outcome has not been performed. Because a geriatric assessment has proved useful in predicting outcome in other medical fields, its potential role in the ESRD population should be the subject of future research. PMID:27117581

Origin and outcome of multiple pregnancies in Bern, Switzerland, 1995-2006 and the current proposal of the Swiss parliament to revise the Swiss law of reproductive medicine: Switzerland quo vadis?

PubMed

Wunder, Dorothea; Neurohr, Eva-Maria; Faouzi, Mohamed; Birkhäuser, Martin H

2013-09-19

Infertility treatments are a major source of the increase in multiple pregnancies (MPs). The aims of the present study were (1.) to investigate the origin and maternal/neonatal outcomes of MP and (2.) to review the different measures that can be adopted to reduce these serious complications. The study included all women with multiple births between 1 January 1995 and 31 December 2006 at the University Hospital of Bern, Switzerland. The outcomes associated with the various origins of MP (natural conception, ovarian stimulation [OS]--in-vitro fertilisation [IVF-ICSI]) were analysed using a multinomial logistic regression model. An analysis of the Swiss law on reproductive medicine and its current proposed revision, as well as a literature review using Pubmed, was carried out. A total of 592 MP were registered, 91% (n = 537) resulted in live births. There was significantly more neonatal/maternal morbidity in MP after OS compared with natural conception and even with the IVF-ICSI group. With a policy of elective single embryo transfer (eSET), twin rates after IVF-ICSI can be reduced to <5% and triplets to <1%. After OS, more triplets are found and the outcome of MP is worse. MP is known to be associated with morbidity, mortality, and economic and social risks. To counteract these complications (1.) better training for physicians performing OS should be encouraged and (2.) the Swiss law on reproductive medicine needs to be changed, with the introduction of eSET policies. This would lead to a dramatic decrease in neonatal and maternal morbidity/mortality as well as significant cost reductions for the Swiss healthcare system.

Using Multiple Sources of Data to Gauge Outcome Differences between Academic-Themed and Transition-Themed First-Year Seminars

ERIC Educational Resources Information Center

Zerr, Ryan J.; Bjerke, Elizabeth

2016-01-01

Students in two different types of first-year experience seminar courses at a moderately sized public university were compared using a large variety of measures--both direct and indirect. One of these first-year experience types was a three-credit academic-themed course offered in sections with variable content; the other was a two-credit…

Student Perceptions of Elementary School Climates in the Louisiana School Effectiveness Study: A Comparison of Phase III and Phase IV.

ERIC Educational Resources Information Center

Roberts, Sharon Pol; Heroman, Deborah S.

A 5-year study examined third-graders' perceptions of school climate in 16 Louisiana schools. Part of the Louisiana School Effectiveness Study (LSES), Phase III and IV examined student perceptions in 1984-85 and 1989-90, respectively, and also gathered demographic data and multiple measures of student outcomes through student surveys and classroom…

A New Zealand pilot randomized controlled trial of a web-based interactive self-management programme (MSInvigor8) with and without email support for the treatment of multiple sclerosis fatigue.

PubMed

van Kessel, Kirsten; Wouldes, Trecia; Moss-Morris, Rona

2016-05-01

To pilot and compare the efficacy of an internet-based cognitive behavioural therapy self-management programme with (MSInvigor8-Plus) and without (MSInvigor8-Only) the use of email support in reducing fatigue severity and impact (primary outcomes), and depressed and anxious mood (secondary outcomes). Randomized controlled trial using an independent randomization system built into the website and intention-to-treat analysis. Participants were recruited through the local Multiple Sclerosis Society and hospital neurological services in New Zealand. A total of 39 people (aged 31-63 years), experiencing multiple sclerosis fatigue, able to walk with and without walking aids, were randomized to MSInvigor8-Only (n = 20) or to MSInvigor8-Plus (n = 19). MSInvigor8 is an eight-session programme based on cognitive behaviour therapy principles including psycho-education, self-monitoring, and changing unhelpful activity and thought patterns. Outcome measures included fatigue severity (Chalder Fatigue Scale) and impact (Modified Fatigue Impact Scale), and anxiety and depression (Hospital Anxiety and Depression Scale). Assessments were performed at baseline and at 10 weeks. The MSInvigor8-Plus condition resulted in significantly greater reductions in fatigue severity (F [1,36] = 9.09, p < 0.01) and impact (F [1,36] = 6.03, p < 0.02) compared with the MSInvigor8-Only condition. Large between-group effect sizes for fatigue severity (d = 0.99) and fatigue impact (d = 0.81) were obtained. No significant differences were found between the groups on changes in anxiety and depression. MSInvigor8 delivered with email-based support is a potentially promising, acceptable, and cost-effective approach to treating fatigue in people with multiple sclerosis in New Zealand. © The Author(s) 2015.

Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE).

PubMed

2017-03-30

Objective  To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment. Design  Pragmatic, multicentre, open label, parallel group, cluster randomised controlled trial (Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial). Setting  Eight secondary care centres in England and Scotland. Participants  Adults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment ("dose adjustment for normal eating," DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections. Interventions  Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main outcome measures  The primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction. Results  317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was -0.85% with pump treatment and -0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was -0.24% (-2.7 mmol/mol) in favour of pump users (95% confidence interval -0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months. Conclusions  Both groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants' level of engagement in intensive self management have been determined. Trial registration  Current Controlled Trials ISRCTN61215213. 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.

Assessing the treatment effects in apraxia of speech: introduction and evaluation of the Modified Diadochokinesis Test.

PubMed

Hurkmans, Joost; Jonkers, Roel; Boonstra, Anne M; Stewart, Roy E; Reinders-Messelink, Heleen A

2012-01-01

The number of reliable and valid instruments to measure the effects of therapy in apraxia of speech (AoS) is limited. To evaluate the newly developed Modified Diadochokinesis Test (MDT), which is a task to assess the effects of rate and rhythm therapies for AoS in a multiple baseline across behaviours design. The consistency, accuracy and fluency of speech of 24 adults with AoS and 12 unaffected speakers matched for age, gender and educational level were assessed using the MDT. The reliability and validity of the instrument were considered and outcomes compared with those obtained with existing tests. The results revealed that MDT had a strong internal consistency. Scores were influenced by syllable structure complexity, while distinctive features of articulation had no measurable effect. The test-retest and intra- and inter-rater reliabilities were shown to be adequate, and the discriminant validity was good. For convergent validity different outcomes were found: apart from one correlation, the scores on tests assessing functional communication and AoS correlated significantly with the MDT outcome measures. The spontaneous speech phonology measure of the Aachen Aphasia Test (AAT) correlated significantly with the MDT outcome measures, but no correlations were found for the repetition subtest and the spontaneous speech articulation/prosody measure of the AAT. The study shows that the MDT has adequate psychometric properties, implying that it can be used to measure changes in speech motor control during treatment for apraxia of speech. The results demonstrate the validity and utility of the instrument as a supplement to speech tasks in assessing speech improvement aimed at the level of planning and programming of speech. © 2012 Royal College of Speech and Language Therapists.

Social and health outcomes following upgrades to a national housing standard: a multilevel analysis of a five-wave repeated cross-sectional survey.

PubMed

Poortinga, Wouter; Jones, Nikki; Lannon, Simon; Jenkins, Huw

2017-12-02

While existing research indicates that housing improvements are associated with health improvements, less is known about the wider social and health benefits of meeting national housing standards, as well as those of their specific constituent measures. This study evaluates the impacts of a managed housing upgrade programme through a repeated cross-sectional survey design. A five-wave repeated cross-sectional survey was conducted over a seven-year period from 2009 to 2016 (n = 2075; n = 2219; n = 2015; n = 1991; and n = 1709, respectively). The study followed a managed upgrade programme designed to meet a national social housing standard over an extended period. The data were analysed from a multilevel perspective to take account of the time-dependent nature of the observations and differences in socio-demographic composition. The installation of the majority of individual housing measures (new windows and doors; boilers; kitchens; bathrooms; electrics; loft insulation; and cavity/external wall insulation) were associated with improvements in several social (housing suitability, satisfaction, and quality; thermal comfort and household finances) and health (mental, respiratory and general health) outcomes; and analyses showed relationships between the number of measures installed and the total amount invested on the one hand and the social and health outcomes on the other. There were however a few exceptions. Most notably, the installation of cavity wall insulation was associated with poorer health outcomes, and did not lead to better social outcomes. Also, no association was found between the number of measures installed and respiratory health. The study suggests that substantial housing investments through a managed upgrade programme may result in better social and health outcomes, and that the size of the improvements are proportionate to the number of measures installed and amount invested. However, there may be risks associated with specific measures; and more attention is needed for mechanical ventilation when upgrading energy efficiency of houses through fabric work. In addition to providing new evidence regarding the wider social and health outcomes, the study provides an analytical approach to evaluate upgrade programmes that are delivered over multiple years.

Multivariate meta-analysis of prognostic factor studies with multiple cut-points and/or methods of measurement.

PubMed

Riley, Richard D; Elia, Eleni G; Malin, Gemma; Hemming, Karla; Price, Malcolm P

2015-07-30

A prognostic factor is any measure that is associated with the risk of future health outcomes in those with existing disease. Often, the prognostic ability of a factor is evaluated in multiple studies. However, meta-analysis is difficult because primary studies often use different methods of measurement and/or different cut-points to dichotomise continuous factors into 'high' and 'low' groups; selective reporting is also common. We illustrate how multivariate random effects meta-analysis models can accommodate multiple prognostic effect estimates from the same study, relating to multiple cut-points and/or methods of measurement. The models account for within-study and between-study correlations, which utilises more information and reduces the impact of unreported cut-points and/or measurement methods in some studies. The applicability of the approach is improved with individual participant data and by assuming a functional relationship between prognostic effect and cut-point to reduce the number of unknown parameters. The models provide important inferential results for each cut-point and method of measurement, including the summary prognostic effect, the between-study variance and a 95% prediction interval for the prognostic effect in new populations. Two applications are presented. The first reveals that, in a multivariate meta-analysis using published results, the Apgar score is prognostic of neonatal mortality but effect sizes are smaller at most cut-points than previously thought. In the second, a multivariate meta-analysis of two methods of measurement provides weak evidence that microvessel density is prognostic of mortality in lung cancer, even when individual participant data are available so that a continuous prognostic trend is examined (rather than cut-points). © 2015 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Evidence for Updating the Core Domain Set of Outcome Measures for Juvenile Idiopathic Arthritis: Report from a Special Interest Group at OMERACT 2016.

PubMed

Morgan, Esi M; Riebschleger, Meredith P; Horonjeff, Jennifer; Consolaro, Alessandro; Munro, Jane E; Thornhill, Susan; Beukelman, Timothy; Brunner, Hermine I; Creek, Emily L; Harris, Julia G; Horton, Daniel B; Lovell, Daniel J; Mannion, Melissa L; Olson, Judyann C; Rahimi, Homaira; Gallo, Maria Chiara; Calandra, Serena; Ravelli, Angelo; Ringold, Sarah; Shenoi, Susan; Stinson, Jennifer; Toupin-April, Karine; Strand, Vibeke; Bingham, Clifton O

2017-12-01

The current Juvenile Idiopathic Arthritis (JIA) Core Set was developed in 1997 to identify the outcome measures to be used in JIA clinical trials using statistical and consensus-based techniques, but without patient involvement. The importance of patient/parent input into the research process has increasingly been recognized over the years. An Outcome Measures in Rheumatology (OMERACT) JIA Core Set Working Group was formed to determine whether the outcome domains of the current core set are relevant to those involved or whether the core set domains should be revised. Twenty-four people from the United States, Canada, Australia, and Europe, including patient partners, formed the working group. Guided by the OMERACT Filter 2.0 process, we performed (1) a systematic literature review of outcome domains, (2) a Web-based survey (142 patients, 343 parents), (3) an idea-generation study (120 parents), (4) 4 online discussion boards (24 patients, 20 parents), and (5) a Special Interest Group (SIG) activity at the OMERACT 13 (2016) meeting. A MEDLINE search of outcome domains used in studies of JIA yielded 5956 citations, of which 729 citations underwent full-text review, and identified additional domains to those included in the current JIA Core Set. Qualitative studies on the effect of JIA identified multiple additional domains, including pain and participation. Twenty-one participants in the SIG achieved consensus on the need to revise the entire JIA Core Set. The results of qualitative studies and literature review support the need to expand the JIA Core Set, considering, among other things, additional patient/parent-centered outcomes, clinical data, and imaging data.

Does long-term outcome after intensive inpatient rehabilitation of acquired brain injury depend on etiology?

PubMed

Blicher, Jakob Udby; Nielsen, Jørgen Feldbaek

2008-01-01

To identify predictors of outcome, epilepsy, spasticity and depression one year after severe acquired brain injury. Retrospective cohort study. A consecutive sample of 165 patients with severe acquired brain injury admitted for inpatient rehabilitation during a 18-month time period, was contacted and offered home visits one-year after brain injury. Of the 165 patients 12 did not participate. The cohort included patients with different etiologies primarily traumatic brain injury (65), stroke (25) and subarachnoid hemorrhage (34). Functional independent measure (FIM) was measured at admission at rehabilitation unit and at follow-up. At follow-up the presence of epilepsy, spasticity, and depression was evaluated. Using multiple logistic regression a short length of stay at acute hospital (LOS1) (P=0.004), a high FIM score at admission (P<0.001), and low age (P=0.003), were all predictors of good outcome. No difference was found between etiologies (P=0.077). The presence of spasticity was predicted by low FIM score (P< 0.001), longer LOS1 (P< 0.036), etiology (P< 0.001), and lower age (P=0.001). Depression was predicted by higher age (P=0.035). Age, functional status, and length of acute hospital stay are associated with outcome one year after brain injury. The functional outcome was not correlated to etiology.

Persistent hypogonadism influences estradiol synthesis, cognition and outcome in males after severe TBI.

PubMed

Wagner, Amy K; Brett, Christopher A; McCullough, Emily H; Niyonkuru, Christian; Loucks, Tammy L; Dixon, C Edward; Ricker, Joseph; Arenth, Patricia; Berga, Sarah L

2012-01-01

Acute hypogonadotropic hypogonadism (AHH) occurs frequently after TBI, as does chronic hypogonadotropic hypogonadism. However, AHH and persistent hypogonadotropic hypogonadism (PHH) after TBI are not well studied. The objective of this study was to characterize longitudinal hormone profiles and the impact of AHH and PHH on outcome. In this prospective cohort study, men with severe TBI (n = 38) had serum gonadal and gonadotropic hormones measured during weeks 1-52 post-injury. AHH, PHH and/or early resolving hypogonadotropic hypogonadism (ERHH) were based on temporal hormone assessments. PHH and hormone profiles were then compared to multiple outcome measures 6-12 months post-TBI. AHH affected 100% of the population, while 37% subsequently developed PHH. Acute testosterone (TEST) and estradiol/testosterone (E2/TEST) ratios were associated with PHH and outcome. Over time, post-acute TEST and E2 levels for the ERHH group approached normal range, while levels for the PHH group remained low. Post-acute gonadotrophin levels were within the normal range for both groups. PHH, along with lower post-acute TEST and E2 profiles, was associated with worse functional and cognitive outcomes at 6 and 12 months post-injury. These results support screening for post-acute secondary hypogonadism and further research to assess the mechanisms underlying PHH and associated functional and cognitive deficits.

Enhanced recovery after surgery: Current research insights and future direction

PubMed Central

Abeles, Aliza; Kwasnicki, Richard Mark; Darzi, Ara

2017-01-01

Since the concept of enhanced recovery after surgery (ERAS) was introduced in the late 1990s the idea of implementing specific interventions throughout the peri-operative period to improve patient recovery has been proven to be beneficial. Minimally invasive surgery is an integral component to ERAS and has dramatically improved post-operative outcomes. ERAS can be applicable to all surgical specialties with the core generic principles used together with added specialty specific interventions to allow for a comprehensive protocol, leading to improved clinical outcomes. Diffusion of ERAS into mainstream practice has been hindered due to minimal evidence to support individual facets and lack of method for monitoring and encouraging compliance. No single outcome measure fully captures recovery after surgery, rather multiple measures are necessary at each stage. More recently the pre-operative period has been the target of a number of strategies to improve clinical outcomes, described as prehabilitation. Innovation of technology in the surgical setting is also providing opportunities to overcome the challenges within ERAS, e.g., the use of wearable activity monitors to record information and provide feedback and motivation to patients peri-operatively. Both modernising ERAS and providing evidence for key strategies across specialties will ultimately lead to better, more reliable patient outcomes. PMID:28289508

Association between socioeconomic status, learned helplessness, and disease outcome in patients with inflammatory polyarthritis.

PubMed

Camacho, E M; Verstappen, S M M; Symmons, D P M

2012-08-01

Independent investigations have shown that socioeconomic status (SES) and learned helplessness (LH) are associated with poor disease outcome in patients with rheumatoid arthritis (RA). Our aim was to investigate the cross-sectional relationship between SES, LH, and disease outcome in patients with recent-onset inflammatory polyarthritis (IP), the broader group of conditions of which RA is the major constituent. SES was measured using the Index of Multiple Deprivation 2007 for 553 patients consecutively recruited to the Norfolk Arthritis Register. Patients also completed the Rheumatology Attitudes Index, a measure of LH. SES and LH were investigated as predictors of disease outcome (functional disability [Health Assessment Questionnaire (HAQ)] and disease activity [Disease Activity Score in 28 joints]) in a regression analysis, adjusted for age, sex, and symptom duration. The role of LH in the relationship between SES and disease outcome was then investigated. Compared to patients of the highest SES, those of the lowest SES had a significantly worse outcome (median difference in HAQ score 0.42; 95% confidence interval [95% CI] 0.08, 0.75). Compared to patients with normal LH, patients with low LH had a significantly better outcome and patients with high LH had a significantly worse outcome (median difference in HAQ score 1.12; 95% CI 0.82, 1.41). There was a significant likelihood that LH mediated the association between SES and disease outcome (P = 0.04). LH is robustly associated with cross-sectional disease outcome in patients with IP, and appears to mediate the relationship between SES and disease outcome. As LH is potentially modifiable, these findings have potential clinical implications. Copyright © 2012 by the American College of Rheumatology.

Association between socioeconomic status, learned helplessness, and disease outcome in patients with inflammatory polyarthritis

PubMed Central

Camacho, E M; Verstappen, S M M; Symmons, D P M

2012-01-01

Objective Independent investigations have shown that socioeconomic status (SES) and learned helplessness (LH) are associated with poor disease outcome in patients with rheumatoid arthritis (RA). Our aim was to investigate the cross-sectional relationship between SES, LH, and disease outcome in patients with recent-onset inflammatory polyarthritis (IP), the broader group of conditions of which RA is the major constituent. Methods SES was measured using the Index of Multiple Deprivation 2007 for 553 patients consecutively recruited to the Norfolk Arthritis Register. Patients also completed the Rheumatology Attitudes Index, a measure of LH. SES and LH were investigated as predictors of disease outcome (functional disability [Health Assessment Questionnaire (HAQ)] and disease activity [Disease Activity Score in 28 joints]) in a regression analysis, adjusted for age, sex, and symptom duration. The role of LH in the relationship between SES and disease outcome was then investigated. Results Compared to patients of the highest SES, those of the lowest SES had a significantly worse outcome (median difference in HAQ score 0.42; 95% confidence interval [95% CI] 0.08, 0.75). Compared to patients with normal LH, patients with low LH had a significantly better outcome and patients with high LH had a significantly worse outcome (median difference in HAQ score 1.12; 95% CI 0.82, 1.41). There was a significant likelihood that LH mediated the association between SES and disease outcome (P = 0.04). Conclusion LH is robustly associated with cross-sectional disease outcome in patients with IP, and appears to mediate the relationship between SES and disease outcome. As LH is potentially modifiable, these findings have potential clinical implications. PMID:22438290

Exploring the Link between Caregiver Affect and Adolescent Sexual Behavior: Does Neighborhood Disadvantage Matter?

PubMed Central

Gardner, Margo; Martin, Anne; Brooks-Gunn, Jeanne

2011-01-01

In a sample of urban youth (N = 1,070), we examined the links between primary caregiver affect (i.e., warmth and hostility) and two measures of sexual behavior in adolescence – early sexual initiation and sex with multiple partners. We also examined the extent to which neighborhood disadvantage moderated associations between caregiver affect and adolescent sexual behavior. We found that caregiver hostility was positively associated with early sex and sex with multiple partners in neighborhoods characterized by high levels of disadvantage, but inversely associated with both sex outcomes in neighborhoods characterized by low levels of disadvantage. Caregiver warmth, on the other hand, was inversely associated with early sexual initiation and sex with multiple partners in all neighborhoods regardless of neighborhood disadvantage. PMID:22408364

Impact of Fetal Versus Perinatal Hypoxia on Sex Differences in Childhood Outcomes: Developmental Timing Matters

PubMed Central

Anastario, Michael; Salafia, Carolyn M.; Fitzmaurice, Garrett; Goldstein, Jill M.

2013-01-01

Purpose To examine how the timing of hypoxic exposure results in specific childhood outcomes and whether there is a differential effect by sex. Methods A sample of 10,879 prospectively followed pregnancies was drawn from the Boston and Providence sites (New England-NE) of the National Collaborative Perinatal Project. Based on placental pathology, we developed and validated a measure of probable chronic fetal hypoxia (CHP) and contrasted the effects of acute perinatal hypoxia on age 7 emotional, behavioral, and cognitive outcomes. Results Perinatal hypoxia had a significant impact on multiple behavioral and cognitive outcomes in boys and girls by age 7, in contrast to probable CHP which had a differential effect on girls and boys such that there was decreased verbal IQ and increased inhibition in females alone. Conclusions Findings underscore the importance of considering the timing of obstetric complications and offspring sex in investigations of the impact of fetal and perinatal hypoxia on offspring’s outcomes throughout the life course. PMID:21327969

Dimensions of care for dementia sufferers in long-term care institutions: are they related to outcomes?

PubMed

Chappell, N L; Reid, R C

2000-07-01

This study empirically examined whether dimensions of care cluster in special care units (SCUs) compared with non-SCUs. The relationship between SCU status plus separate measures of the dimensions of care and outcomes for dementia sufferers was then investigated. Data were drawn from the Intermediate Care Facility Project. The sample (N = 510) included residents with dementia, aged 65 and older, in intermediate care facilities throughout the province of British Columbia. Canada. Longitudinal data included 6 outcomes: cognitive function, behavioral problems of agitation and social skills, physical functioning, and quality of life measured through affect and expressive language skills. Separate multiple linear regression equations were estimated, relating each of these outcomes to 5 dimensions of care: preadmission and admission procedures. staff training and education, nonuse of physical and chemical restraints, flexible care routines and resident-relevant activities, and the environment. The results showed there is virtually no clustering of dimensions along SCU/non-SCU lines. Neither SCU status nor the individual dimensions were highly predictive of outcomes. Residents' affect at t1 emerged as a characteristic that was significantly correlated with other outcomes. This Canadian research can be added to the few but growing number of rigorous studies that suggest SCUs are not homogeneous and do not necessarily provide better care than non-SCUs. Moreover, it raises questions about the benefits of "best practice" dimensions of care, regardless of SCU status.

Powered exoskeletons for bipedal locomotion after spinal cord injury

NASA Astrophysics Data System (ADS)

Contreras-Vidal, Jose L.; Bhagat, Nikunj A.; Brantley, Justin; Cruz-Garza, Jesus G.; He, Yongtian; Manley, Quinn; Nakagome, Sho; Nathan, Kevin; Tan, Su H.; Zhu, Fangshi; Pons, Jose L.

2016-06-01

Objective. Powered exoskeletons promise to increase the quality of life of people with lower-body paralysis or weakened legs by assisting or restoring legged mobility while providing health benefits across multiple physiological systems. Here, a systematic review of the literature on powered exoskeletons addressed critical questions: What is the current evidence of clinical efficacy for lower-limb powered exoskeletons? What are the benefits and risks for individuals with spinal cord injury (SCI)? What are the levels of injury considered in such studies? What are their outcome measures? What are the opportunities for the next generation exoskeletons? Approach. A systematic search of online databases was performed to identify clinical trials and safety or efficacy studies with lower-limb powered exoskeletons for individuals with SCI. Twenty-two studies with eight powered exoskeletons thus selected, were analyzed based on the protocol design, subject demographics, study duration, and primary/secondary outcome measures for assessing exoskeleton's performance in SCI subjects. Main results. Findings show that the level of injury varies across studies, with T10 injuries being represented in 45.4% of the studies. A categorical breakdown of outcome measures revealed 63% of these measures were gait and ambulation related, followed by energy expenditure (16%), physiological improvements (13%), and usability and comfort (8%). Moreover, outcome measures varied across studies, and none had measures spanning every category, making comparisons difficult. Significance. This review of the literature shows that a majority of current studies focus on thoracic level injury as well as there is an emphasis on ambulatory-related primary outcome measures. Future research should: 1) develop criteria for optimal selection and training of patients most likely to benefit from this technology, 2) design multimodal gait intention detection systems that engage and empower the user, 3) develop real-time monitoring and diagnostic capabilities, and 4) adopt comprehensive metrics for assessing safety, benefits, and usability.

The effectiveness of lifestyle triple P in the Netherlands: a randomized controlled trial.

PubMed

Gerards, Sanne M P L; Dagnelie, Pieter C; Gubbels, Jessica S; van Buuren, Stef; Hamers, Femke J M; Jansen, Maria W J; van der Goot, Odilia H M; de Vries, Nanne K; Sanders, Matthew R; Kremers, Stef P J

2015-01-01

Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4-8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children's body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children's dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (short-term) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. No intervention effects were found on children's body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children's soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent's report of children's time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Although the Lifestyle Triple P intervention showed positive effects on some parent reported child behaviors and parenting measures, no effects were visible on children's body composition or objectively measured physical activity. Several adjustments of the intervention content are recommended, for example including a booster session. Nederlands Trial Register NTR 2555.

An introduction to clinical microeconomic analysis: purposes and analytic methods.

PubMed

Weintraub, W S; Mauldin, P D; Becker, E R

1994-06-01

The recent concern with health care economics has fostered the development of a new discipline that is generally called clinical microeconomics. This is a discipline in which microeconomic methods are used to study the economics of specific medical therapies. It is possible to perform stand alone cost analyses, but more profound insight into the medical decision making process may be accomplished by combining cost studies with measures of outcome. This is most often accomplished with cost-effectiveness or cost-utility studies. In cost-effectiveness studies there is one measure of outcome, often death. In cost-utility studies there are multiple measures of outcome, which must be grouped together to give an overall picture of outcome or utility. There are theoretical limitations to the determination of utility that must be accepted to perform this type of analysis. A summary statement of outcome is quality adjusted life years (QALYs), which is utility time socially discounted survival. Discounting is used because people value a year of future life less than a year of present life. Costs are made up of in-hospital direct, professional, follow-up direct, and follow-up indirect costs. Direct costs are for medical services. Indirect costs reflect opportunity costs such as lost time at work. Cost estimates are often based on marginal costs, or the cost for one additional procedure of the same type. Finally an overall statistic may be generated as cost per unit increase in effectiveness, such as dollars per QALY.(ABSTRACT TRUNCATED AT 250 WORDS)

Sigsearch: a new term for post hoc unplanned search for statistically significant relationships with the intent to create publishable findings.

PubMed

Hashim, Muhammad Jawad

2010-09-01

Post-hoc secondary data analysis with no prespecified hypotheses has been discouraged by textbook authors and journal editors alike. Unfortunately no single term describes this phenomenon succinctly. I would like to coin the term "sigsearch" to define this practice and bring it within the teaching lexicon of statistics courses. Sigsearch would include any unplanned, post-hoc search for statistical significance using multiple comparisons of subgroups. It would also include data analysis with outcomes other than the prespecified primary outcome measure of a study as well as secondary data analyses of earlier research.

Quantum origin of quantum jumps: Breaking of unitary symmetry induced by information transfer in the transition from quantum to classical

NASA Astrophysics Data System (ADS)

Zurek, Wojciech Hubert

2007-11-01

Measurements transfer information about a system to the apparatus and then, further on, to observers and (often inadvertently) to the environment. I show that even imperfect copying essential in such situations restricts possible unperturbed outcomes to an orthogonal subset of all possible states of the system, thus breaking the unitary symmetry of its Hilbert space implied by the quantum superposition principle. Preferred outcome states emerge as a result. They provide a framework for “wave-packet collapse,” designating terminal points of quantum jumps and defining the measured observable by specifying its eigenstates. In quantum Darwinism, they are the progenitors of multiple copies spread throughout the environment—the fittest quantum states that not only survive decoherence, but subvert the environment into carrying information about them—into becoming a witness.

Outcome following therapeutic abortion.

PubMed

Payne, E C; Kravitz, A R; Notman, M T; Anderson, J V

1976-06-01

Psychological outcome of abortion was studied in 102 patients, measuring multiple variables over four time intervals. Five measured affects--anxiety, depression, anger, guilt, and shame-were significantly lower six months after the preabortion period. The following variables describe subgroups of patients with significant variations in patterns of responses as indicated by changes in affects: marital status, personality diagnosis, character of object relations, past psychopathologic factors, relationship to husband or lover, relationship to mother, ambivalence about abortion, religion, and previous parity. A complex multivariate model, based on conflict and conflict resolution, is appropriate to conceptualize, the unwanted pregnancy and abortion experience. Data suggest that women most vulnerable to conflict are those who are single and nulliparous, those with previous history of serious emotional problems, conflictual relationships to lovers, past negative relationships to mother, strong ambivalence toward abortion, or negative religious or cultural attitudes about abortion.

Vascular Multiplicity Should Not Be a Contra-Indication for Live Kidney Donation and Transplantation

PubMed Central

van Bruggen, Mark; Kimenai, Hendrikus J. A. N.; Tran, Thi C. K.; Terkivatan, Türkan; Betjes, Michiel G. H.; IJzermans, Jan N. M.; Dor, Frank J. M. F.

2016-01-01

Background Whether vascular multiplicity should be considered as contraindication and therefore ‘extended donor criterion’ is still under debate. Methods Data from all live kidney donors from 2006–2013 (n = 951) was retrospectively reviewed. Vascular anatomy as imaged by MRA, CTA or other modalities was compared with intraoperative findings. Furthermore, the influence of vascular multiplicity on outcome of donors and recipients was studied. Results In 237 out of 951 donors (25%), vascular multiplicity was present. CTA had the highest accuracy levels regarding vascular anatomy assessment. Regarding outcome of donors with vascular multiplicity, warm ischemia time (WIT) and skin-to-skin time were significantly longer if arterial multiplicity (AM) was present (5.1 vs. 4.0 mins and 202 vs. 178 mins). Skin-to-skin time was significantly longer, and complication rates were higher in donors with venous multiplicity (203 vs. 180 mins and 17.2% vs. 8.4%). Outcome of renal transplant recipients showed a significantly increased WIT (30 vs. 26.7 minutes), higher rate of DGF (13.9% vs. 6.9%) and lower rate of BPAR (6.9% vs. 13.9%) in patients receiving a kidney with AM compared to kidneys with singular anatomy. Conclusions We conclude that vascular multiplicity should not be a contra-indication, since it has little impact on clinical outcome in the donor as well as in renal transplant recipients. PMID:27077904

Vascular Multiplicity Should Not Be a Contra-Indication for Live Kidney Donation and Transplantation.

PubMed

Lafranca, Jeffrey A; van Bruggen, Mark; Kimenai, Hendrikus J A N; Tran, Thi C K; Terkivatan, Türkan; Betjes, Michiel G H; IJzermans, Jan N M; Dor, Frank J M F

2016-01-01

Whether vascular multiplicity should be considered as contraindication and therefore 'extended donor criterion' is still under debate. Data from all live kidney donors from 2006-2013 (n = 951) was retrospectively reviewed. Vascular anatomy as imaged by MRA, CTA or other modalities was compared with intraoperative findings. Furthermore, the influence of vascular multiplicity on outcome of donors and recipients was studied. In 237 out of 951 donors (25%), vascular multiplicity was present. CTA had the highest accuracy levels regarding vascular anatomy assessment. Regarding outcome of donors with vascular multiplicity, warm ischemia time (WIT) and skin-to-skin time were significantly longer if arterial multiplicity (AM) was present (5.1 vs. 4.0 mins and 202 vs. 178 mins). Skin-to-skin time was significantly longer, and complication rates were higher in donors with venous multiplicity (203 vs. 180 mins and 17.2% vs. 8.4%). Outcome of renal transplant recipients showed a significantly increased WIT (30 vs. 26.7 minutes), higher rate of DGF (13.9% vs. 6.9%) and lower rate of BPAR (6.9% vs. 13.9%) in patients receiving a kidney with AM compared to kidneys with singular anatomy. We conclude that vascular multiplicity should not be a contra-indication, since it has little impact on clinical outcome in the donor as well as in renal transplant recipients.

Effect of a nighttime magnetic field exposure on sleep patterns in young women.

PubMed

Tworoger, Shelley S; Davis, Scott; Emerson, Scott S; Mirick, Dana K; Lentz, Martha J; McTiernan, Anne

2004-08-01

Since poor sleep quality is associated with multiple health problems, it is important to understand factors that may affect sleep patterns. The purpose of this study was to determine the effect of a continuous, 60-Hz, nighttime magnetic field exposure on sleep outcomes in young women sleeping at home. The study was a randomized crossover trial, comparing intervention (0.5-1.0 micro T above ambient levels) with ambient magnetic field levels, during two 5-night measurement periods. Subjects lived in the Seattle, Washington, area and were 20-40 years of age, had regular menstrual cycles, were not taking oral contraceptives, and had not breastfed or been pregnant during the previous year. The study was conducted between March and September of 2001. Sleep outcomes were measured via actigraphy. The range of magnetic field exposure was 0.001-0.50 micro T during the ambient period and 0.41-1.21 micro T during the intervention period. Sleep outcomes were not significantly different between the intervention and the ambient measurement periods. The intervention magnetic field had no effect on sleep patterns, suggesting that this exposure may not be an important factor in predicting sleep of young women who sleep at home.

Personal investment, culture and learning: insights into school achievement across Anglo, Aboriginal, Asian and Lebanese students in Australia.

PubMed

McInerney, Dennis M

2008-10-01

Personal investment theory is a multifaceted theory of motivation, in which three key components: achievement goals (mastery, performance, social, and extrinsic), sense of self (sense of purpose, self-reliance, negative self-concept, positive self-concept), and facilitating conditions (parent support, teacher support, peer support), engage students in the process of learning. Four cultural groups (Anglo Australian, n = 852, Aboriginal Australian, n = 343, Lebanese Australian, n = 372, and Asian Australian, n = 283) of students were compared on these personal investment components and on several outcome measures (engagement, affect, achievement, participation). A series of MANOVAs, followed up by univariate tests, indicated ethnic differences and similarities in the endorsement of the personal investment theory components as well as in the outcome measures. Multiple regression analyses showed that each of the three sets of predictors (achievement goals, sense of self, facilitating conditions) explained a significant amount of the variance in almost all of the outcome measures. Across cultural groups, students' mastery goal and sense of purpose were consistently found to be significant predictors of their intention for further education, positive affect for schooling, and valuing of schooling.

The Use of Online Modules and the Effect on Student Outcomes in a High School Chemistry Class

NASA Astrophysics Data System (ADS)

Lamb, Richard L.; Annetta, Len

2013-10-01

The purpose of the study was to review the efficacy of online chemistry simulations in a high school chemistry class and provide discussion of the factors that may affect student learning. The sample consisted of 351 high school students exposed to online simulations. Researchers administered a pretest, intermediate test and posttest to measure chemistry content knowledge acquired during the use of online chemistry laboratory simulations. The authors also analyzed student journal entries as an attitudinal measure of chemistry during the simulation experience. The four analyses conducted were Repeated Time Measures Analysis of Variance, a three-way Analysis of Variance, Logistic Regression and Multiple Analysis of Variance. Each of these analyses provides for a slightly different aspect of factors regarding student attitudes and outcomes. Results indicate that there is a statistically significant main effect across grouping type (experimental versus control, p = 0.042, α = 0.05). Analysis of student journal entries suggests that attitudinal factors may affect student outcomes concerning the use of online supplemental instruction. Implications for this study show that the use of online simulations promotes increased understanding of chemistry content through open-ended and interactive questioning.

Factors influencing speech perception in noise for 5-year-old children using hearing aids or cochlear implants.

PubMed

Ching, Teresa Yc; Zhang, Vicky W; Flynn, Christopher; Burns, Lauren; Button, Laura; Hou, Sanna; McGhie, Karen; Van Buynder, Patricia

2017-07-07

We investigated the factors influencing speech perception in babble for 5-year-old children with hearing loss who were using hearing aids (HAs) or cochlear implants (CIs). Speech reception thresholds (SRTs) for 50% correct identification were measured in two conditions - speech collocated with babble, and speech with spatially separated babble. The difference in SRTs between the two conditions give a measure of binaural unmasking, commonly known as spatial release from masking (SRM). Multiple linear regression analyses were conducted to examine the influence of a range of demographic factors on outcomes. Participants were 252 children enrolled in the Longitudinal Outcomes of Children with Hearing Impairment (LOCHI) study. Children using HAs or CIs required a better signal-to-noise ratio to achieve the same level of performance as their normal-hearing peers but demonstrated SRM of a similar magnitude. For children using HAs, speech perception was significantly influenced by cognitive and language abilities. For children using CIs, age at CI activation and language ability were significant predictors of speech perception outcomes. Speech perception in children with hearing loss can be enhanced by improving their language abilities. Early age at cochlear implantation was also associated with better outcomes.

Mobility one week after a hip fracture - can it be predicted?

PubMed

Fitzgerald, Michelle; Blake, Catherine; Askin, David; Quinlan, John; Coughlan, Tara; Cunningham, Caitriona

2018-05-01

Better patient outcomes and more efficient healthcare could be achieved by predicting post hip fracture function at an early stage. This study aimed to identify independent predictors of mobility outcome one week post hip fracture surgery. All hip fracture inpatients (n=77) were included in this 6 month prospective observational cohort study. Predictor variables were obtained on the first postoperative day and included premorbid function using the New Mobility Score (NMS). Mobility outcome measures one week postoperatively included the Cumulated Ambulatory Score (CAS). Data were analysed with SPSS using binary multiple logistic regression analysis RESULTS: Patients who fell outdoors (OR 3.848; 95% CI, 1.053-14.061), had no delay to surgery (OR 5.472; 95% CI, 1.073-27.907) and had high pre-fracture function (OR3.366; 95% CI, 1.042-10.879) were predicted to achieve independent mobility (CAS = 6) one week postoperatively. Fall location, time to surgery and baseline function predict independent mobility one week after hip fracture, and can be used for early rehabilitation stratification. The NMS and CAS are recommended as standardised hip fracture clinical measures. Orthogeriatric and physiotherapy service initiatives may improve early functional outcome. Copyright © 2017. Published by Elsevier Ltd.

Multiple Chronic Conditions and Labor Force Outcomes: A Population Study of U.S. Adults

PubMed Central

Ward, Brian W.

2015-01-01

Background Although 1-in-5 adults have multiple (≥2) chronic conditions, limited attention has been given to the association between multiple chronic conditions and employment. Methods Cross-sectional data (2011 National Health Interview Survey) and multivariate regression analyses were used to examine the association among multiple chronic conditions, employment, and labor force outcomes for U.S. adults aged 18–64 years, controlling for covariates. Results Among U.S. adults aged 18–64 years (unweighted n=25,458), having multiple chronic conditions reduced employment probability by 11%–29%. Some individual chronic conditions decreased employment probability. Among employed adults (unweighted n=16,096), having multiple chronic conditions increased the average number of work days missed due to injury/illness in the past year by 3–9 days. Conclusions Multiple chronic conditions are be a barrier to employment and increase the number of work days missed, placing affected individuals at a financial disadvantage. Researchers interested in examining consequences of multiple chronic conditions should give consideration to labor force outcomes. PMID:26103096

A case study to illustrate the utility of the Aggregate Exposure Pathway and Adverse Outcome Pathway frameworks for integrating human health and ecological data into cumulative risk assessment

EPA Science Inventory

Cumulative risk assessment (CRA) methods, which evaluate the risk of multiple adverse outcomes (AOs) from multiple chemicals, promote the use of a conceptual site model (CSM) to integrate risk from relevant stressors. The Adverse Outcome Pathway (AOP) framework can inform these r...

Magnetic resonance imaging as a surrogate outcome for multiple sclerosis relapses

PubMed Central

Petkau, J; Reingold, SC; Held, U; Cutter, GR; Fleming, TR; Hughes, MD; Miller, DH; McFarland, HF; Wolinsky, JS

2009-01-01

Background Magnetic resonance imaging (MRI) of lesions in the brain may be the best current candidate for a surrogate biological marker of clinical outcomes in relapsing remitting multiple sclerosis (MS), based on its role as an objective indicator of disease pathology. No biological surrogate marker has yet been validated for MS clinical outcomes. Objective The objective of this study was to use a multi-phased study to determine if a valid surrogate relationship could be demonstrated between counts of contrast enhancing lesions (CELs) and occurrence of relapses in MS. Methods We examined correlations for the concurrent and predictive relationship between CELs over 6 months and MS relapses over the same 6 months and an additional 6 months (total: 12 months), using available data on untreated patients from a large clinical trial and natural history database. Results Concurrent and predictive correlations were inadequate to justify continuation of this study to the planned additional phases required to demonstrate a surrogate relationship between CELs and MS relapses. Conclusions Confidence intervals for correlations between CELs and MS relapses exclude the possibility that CELs can be a good surrogate for relapses over the time scales we investigated. Further exploration of surrogacy between MRI measures and MS clinical outcomes may require improved datasets, the development of MRI techniques that couple better to clinical disease, and the ability to test a wide range of imaging- and clinically-based hypotheses for surrogacy. PMID:18535021

Pediatric multiple sclerosis: Clinical features and outcome.

PubMed

Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo

2016-08-30

Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures. © 2016 American Academy of Neurology.

A county-level cross-sectional analysis of positive deviance to assess multiple population health outcomes in Indiana.

PubMed

Hendryx, Michael; Guerra-Reyes, Lucia; Holland, Benjamin D; McGinnis, Michael Dean; Meanwell, Emily; Middlestadt, Susan E; Yoder, Karen M

2017-10-11

To test a positive deviance method to identify counties that are performing better than statistical expectations on a set of population health indicators. Quantitative, cross-sectional county-level secondary analysis of risk variables and outcomes in Indiana. Data are analysed using multiple linear regression to identify counties performing better or worse than expected given traditional risk indicators, with a focus on 'positive deviants' or counties performing better than expected. Counties in Indiana (n=92) constitute the unit of analysis. Per cent adult obesity, per cent fair/poor health, low birth weight per cent, per cent with diabetes, years of potential life lost, colorectal cancer incidence rate and circulatory disease mortality rate. County performance that outperforms expectations is for the most part outcome specific. But there are a few counties that performed particularly well across most measures. The positive deviance approach provides a means for state and local public health departments to identify places that show better health outcomes despite demographic, social, economic or behavioural disadvantage. These places may serve as case studies or models for subsequent investigations to uncover best practices in the face of adversity and generalise effective approaches to other areas. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Influence of Disruptive Behavior Disorders on Academic Performance and School Functions of Youths with Attention-Deficit/Hyperactivity Disorder.

PubMed

Liu, Chao-Yu; Huang, Wei-Lieh; Kao, Wei-Chih; Gau, Susan Shur-Fen

2017-12-01

Childhood attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder/conduct disorder (ODD/CD) are associated with negative school outcomes. The study aimed to examine the impact of ADHD and ODD/CD on various school functions. 395 youths with ADHD (244 with ADHD + ODD/CD and 151 with ADHD only) and 156 controls received semi-structured psychiatric interviews. School functions were assessed and compared between each group with a multiple-level model. The results showed that youths with ADHD had poorer performance across different domains of school functioning. Youths with ADHD + ODD/CD had more behavioral problems but similar academic performance than those with ADHD only. The multiple linear regression models revealed that ADHD impaired academic performance while ODD/CD aggravated behavioral problems. Our findings imply that comorbid ODD/CD may specifically contribute to social difficulties in youths with ADHD. Measures of early detection and intervention for ODD/CD should be conducted to prevent adverse outcomes.

Prediction of individual probabilities of livebirth and multiple birth events following in vitro fertilization (IVF): a new outcomes counselling tool for IVF providers and patients using HFEA metrics

PubMed Central

Jones, Christopher A.; Christensen, Anna L.; Salihu, Hamisu; Carpenter, William; Petrozzino, Jeffrey; Abrams, Elizabeth; Sills, Eric Scott; Keith, Louis G.

2011-01-01

In vitro fertilization (IVF) has become a standard treatment for subfertility after it was demonstrated to be of value to humans in 1978. However, the introduction of IVF into mainstream clinical practice has been accompanied by concerns regarding the number of multiple gestations that it can produce, as multiple births present significant medical consequences to mothers and offspring. When considering IVF as a treatment modality, a balance must be set between the chance of having a live birth and the risk of having a multiple birth. As IVF is often a costly decision for patients—financially, medically, and emotionally—there is benefit from estimating a patient’s specific chance that IVF could result in a birth as fertility treatment options are contemplated. Historically, a patient’s “chance of success” with IVF has been approximated from institution-based statistics, rather than on the basis of any particular clinical parameter (except age). Furthermore, the likelihood of IVF resulting in a twin or triplet outcome must be acknowledged for each patient, given the known increased complications of multiple gestation and consequent increased risk of poor birth outcomes. In this research, we describe a multivariate risk assessment model that incorporates metrics adapted from a national 7.5-year sampling of the Human Fertilisation & Embryology Authority (HFEA) dataset (1991–1998) to predict reproductive outcome (including estimation of multiple birth) after IVF. To our knowledge, http://www.formyodds.com is the first Software-as-a-Service (SaaS) application to predict IVF outcome. The approach also includes a confirmation functionality, where clinicians can agree or disagree with the computer-generated outcome predictions. It is anticipated that the emergence of predictive tools will augment the reproductive endocrinology consultation, improve the medical informed consent process by tailoring the outcome assessment to each patient, and reduce the potential for adverse outcomes with IVF. PMID:21991292

Prediction of individual probabilities of livebirth and multiple birth events following in vitro fertilization (IVF): a new outcomes counselling tool for IVF providers and patients using HFEA metrics.

PubMed

Jones, Christopher A; Christensen, Anna L; Salihu, Hamisu; Carpenter, William; Petrozzino, Jeffrey; Abrams, Elizabeth; Sills, Eric Scott; Keith, Louis G

2011-01-01

In vitro fertilization (IVF) has become a standard treatment for subfertility after it was demonstrated to be of value to humans in 1978. However, the introduction of IVF into mainstream clinical practice has been accompanied by concerns regarding the number of multiple gestations that it can produce, as multiple births present significant medical consequences to mothers and offspring. When considering IVF as a treatment modality, a balance must be set between the chance of having a live birth and the risk of having a multiple birth. As IVF is often a costly decision for patients-financially, medically, and emotionally-there is benefit from estimating a patient's specific chance that IVF could result in a birth as fertility treatment options are contemplated. Historically, a patient's "chance of success" with IVF has been approximated from institution-based statistics, rather than on the basis of any particular clinical parameter (except age). Furthermore, the likelihood of IVF resulting in a twin or triplet outcome must be acknowledged for each patient, given the known increased complications of multiple gestation and consequent increased risk of poor birth outcomes. In this research, we describe a multivariate risk assessment model that incorporates metrics adapted from a national 7.5-year sampling of the Human Fertilisation & Embryology Authority (HFEA) dataset (1991-1998) to predict reproductive outcome (including estimation of multiple birth) after IVF. To our knowledge, http://www.formyodds.com is the first Software-as-a-Service (SaaS) application to predict IVF outcome. The approach also includes a confirmation functionality, where clinicians can agree or disagree with the computer-generated outcome predictions. It is anticipated that the emergence of predictive tools will augment the reproductive endocrinology consultation, improve the medical informed consent process by tailoring the outcome assessment to each patient, and reduce the potential for adverse outcomes with IVF.

Do patient and proxy agree? Long-term changes in multiple sclerosis physical impact and walking ability on patient-reported outcome scales.

PubMed

Sonder, Judith M; Balk, Lisanne J; Bosma, Libertje V A E; Polman, Chris H; Uitdehaag, Bernard M J

2014-10-01

Patient-reported outcome scales (PROs) are useful in monitoring changes in multiple sclerosis (MS) over time. Although these scales are reliable and valid measures in longitudinal studies in MS patients, it is unknown what the impact is when obtaining longitudinal data from proxies. The objective of this paper is to compare longitudinal changes in patient and proxy responses on PROs assessing physical impact of MS and walking ability. In a prospective observational study, data on the Multiple Sclerosis Impact Scale (MSIS-29 physical) and Multiple Sclerosis Walking Scale (MSWS-12) were obtained from 137 patient-proxy couples at baseline and at two-year follow-up. Demographic and disease-related variables explaining agreement or disagreement between patients and proxies were investigated using linear regression analyses. Full agreement was found in 56% (MSIS) and 62% (MSWS) of the patient-proxy couples. Complete disagreement was very rare for both scales (2% MSIS, 5% MSWS). When patients were more positive than proxies, a higher age, longer disease duration, longer patient-proxy relationship and increased levels of depression, anxiety and caregiver burden in proxies were observed. In the majority of the patient-proxy couples there was agreement. Proxies can serve as a valuable source of information, but caution remains essential when using scores from proxies. © The Author(s), 2014.

Prevalence and characteristics of tremor in the NARCOMS multiple sclerosis registry: a cross-sectional survey

PubMed Central

Rinker, John R; Salter, Amber R; Walker, Harrison; Amara, Amy; Meador, William; Cutter, Gary R

2015-01-01

Objectives (1)To describe the prevalence and severity of tremor in patients with multiple sclerosis (MS) registered within a large North American MS registry; (2) to provide detailed descriptions on the characteristics and severity of tremor in a subset of registrants and (3) to compare several measures of tremor severity for strength of agreement. Setting The North American Research Committee on MS (NARCOMS) registry. Participants Registrants of NARCOMS reporting mild or greater tremor severity. Outcome measures We determined the cross-sectional prevalence of tremor in the NARCOMS registry over three semiannual updates between fall 2010 and fall 2011. A subset of registrants (n=552) completed a supplemental survey providing detailed descriptions of their tremor. Outcomes included descriptive characteristics of their tremors and correlations between outcome measures to determine the strength of agreement in assessing tremor severity. Results The estimated prevalence of tremor in NARCOMS ranged from 45% to 46.8%, with severe tremor affecting 5.5–5.9% of respondents. In the subset completing the supplemental survey, mild tremor severity was associated with younger age of MS diagnosis and tremor onset than those with moderate or severe tremor. However, tremor severity did not differ by duration of disease or tremor. Respondents provided descriptions of tremor symptoms on the Clinical Ataxia Rating Scale, which had a moderate to good (ρ=0.595) correlation with the Tremor Related Activities of Daily Living (TRADL) scale. Objectively scored Archimedes’ spirals had a weaker (ρ=0.358) correlation with the TRADL. Rates of unemployment, disability and symptomatic medication use increased with tremor severity, but were high even among those with mild tremor. Conclusions Tremor is common among NARCOMS registrants and severely disabling for some. Both ADL-based and symptom-descriptive measures of tremor severity can be used to stratify patients. PMID:25573524

Effects of mental demands during dispensing on perceived medication safety and employee well being: A study of workload in pediatric hospital pharmacies

PubMed Central

Holden, Richard J.; Patel, Neal R.; Scanlon, Matthew C.; Shalaby, Theresa M.; Arnold, Judi M.; Karsh, Ben-Tzion

2009-01-01

Background Pharmacy workload is a modifiable work system factor believed to affect both medication safety outcomes and employee outcomes such as job satisfaction. Objectives This study sought to measure the effect of workload on safety and employee outcomes in two pediatric hospitals and to do so using a novel approach to pharmacy workload measurement. Methods Rather than measuring prescription volume or other similar indicators, this study measured the type and intensity of mental demands experienced during the medication dispensing tasks. The effects of external (interruptions, divided attention, rushing) and internal (concentration, effort) task demands on perceived medication error likelihood, adverse drug event likelihood, job dissatisfaction, and burnout were statistically estimated using multiple linear and logistic regression. Results Pharmacists and pharmacy technicians reported high levels of external and internal mental demands during dispensing. The study supported the hypothesis that external demands (interruptions, divided attention, rushing) negatively impacted medication safety and employee well being outcomes. However, as hypothesized, increasing levels of internal demands (concentration and effort) were not associated with greater perceived likelihood of error, adverse drug events, or burnout, and even had a positive effect on job satisfaction. Conclusion Replicating a prior study in nursing, this study shows that new conceptualizations and measures of workload can generate important new findings about both detrimental and beneficial effects of workload on patient safety and employee well being. This study discusses what those findings imply for policy, management, and design concerning automation, cognition, and staffing. PMID:21111387

Effects of mental demands during dispensing on perceived medication safety and employee well-being: a study of workload in pediatric hospital pharmacies.

PubMed

Holden, Richard J; Patel, Neal R; Scanlon, Matthew C; Shalaby, Theresa M; Arnold, Judi M; Karsh, Ben-Tzion

2010-12-01

Pharmacy workload is a modifiable work system factor believed to affect both medication safety outcomes and employee outcomes, such as job satisfaction. This study sought to measure the effect of workload on safety and employee outcomes in 2 pediatric hospitals and to do so using a novel approach to pharmacy workload measurement. Rather than measuring prescription volume or other similar indicators, this study measured the type and intensity of mental demands experienced during the medication dispensing tasks. The effects of external (interruptions, divided attention, and rushing) and internal (concentration and effort) task demands on perceived medication error likelihood, adverse drug event likelihood, job dissatisfaction, and burnout were statistically estimated using multiple linear and logistic regression. Pharmacists and pharmacy technicians reported high levels of external and internal mental demands during dispensing. The study supported the hypothesis that external demands (interruptions, divided attention, and rushing) negatively impacted medication safety and employee well-being outcomes. However, as hypothesized, increasing levels of internal demands (concentration and effort) were not associated with greater perceived likelihood of error, adverse drug events, or burnout and even had a positive effect on job satisfaction. Replicating a prior study in nursing, this study shows that new conceptualizations and measures of workload can generate important new findings about both detrimental and beneficial effects of workload on patient safety and employee well-being. This study discusses what those findings imply for policy, management, and design concerning automation, cognition, and staffing. Copyright © 2010 Elsevier Inc. All rights reserved.

Preoperative psychological adjustment and surgical outcome are determinants of psychosocial status after anterior temporal lobectomy.

PubMed Central

Hermann, B P; Wyler, A R; Somes, G

1992-01-01

This investigation evaluated the role of preoperative psychological adjustment, degree of postoperative seizure reduction, and other relevant variables (age, education, IQ, age at onset of epilepsy, laterality of resection) in determining emotional/psychosocial outcome following anterior temporal lobectomy. Ninety seven patients with complex partial seizures of temporal lobe origin were administered the Minnesota Multiphasic Personality Inventory (MMPI), Washington Psychosocial Seizure Inventory (WPSI), and the General Health Questionnaire (GHQ) both before and six to eight months after anterior temporal lobectomy. The data were subjected to a nonparametric rank sum technique (O'Brien's procedure) which combined the test scores to form a single outcome index (TOTAL PSYCHOSOCIAL OUTCOME) that was analysed by multiple regression procedures. Results indicated that the most powerful predictors of patients' overall postoperative psychosocial outcome were: 1) The adequacy of their preoperative psychosocial adjustment, and 2) A totally seizure-free outcome. Additional analyses were carried out separately on the MMPI, WPSI, and GHQ to determine whether findings varied as a function of the specific outcome measure. These results were related to the larger literature concerned with the psychological outcome of anterior temporal lobectomy. PMID:1619418

Environmental conditions and reproductive health outcomes

EPA Science Inventory

Environmental exposures range across multiple domains to affect human health. In an effort to learn how environmental factors combine to contribute to health outcomes we constructed a multiple environmental domain index (MEDI) for use in health research. We used principal compone...

Supplementation with multiple micronutrients for breastfeeding women for improving outcomes for the mother and baby.

PubMed

Abe, Sarah K; Balogun, Olukunmi O; Ota, Erika; Takahashi, Kenzo; Mori, Rintaro

2016-02-18

Globally, more than two billion people are estimated to be deficient in key vitamins and minerals, particularly iodine, iron and zinc. The majority of these people live in low-income settings and are typically deficient in more than one micronutrient. However, micronutrient deficiency among breastfeeding mothers and their infants also remains an issue in high-income settings, specifically among women who avoid meat and/or milk, women who may lack sufficient supplies of vitamin B12 and vitamin D, and/or women who are iron-deficient. Young children, pregnant and lactating women are particularly vulnerable to micronutrient deficiencies. They not only have a relatively greater need for vitamins and minerals because of their physiological state, but are also more susceptible to the harmful consequences of deficiencies. Multiple-micronutrient supplementation might be an option to solve these problems. The objective of this review was to evaluate the effects of multiple-micronutrient supplementation in breastfeeding mothers on maternal and infant outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2015) and reference lists of retrieved studies. Randomised controlled trials of multiple-micronutrient supplementation of three or more micronutrients versus placebo, no supplementation or supplementation with two or fewer micronutrients, irrespective of dosage of micronutrients, in breastfeeding mothers. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We found no studies that compared multiple-micronutrient supplementation (with three or more micronutrients) versus supplementation with two or fewer micronutrients.Two small studies (involving a total of 52 women) were included. One study compared multiple micronutrients with placebo and the other study compared multiple micronutrients with a group who received no supplementation. The studies were carried out in Brazil (36 adolescent mothers) and the USA (16 women) and included women with a low socioeconomic status. A lack of information in the study reports meant that risk of bias could not be adequately assessed (unclear risk of bias for many domains). There were no quantitative data for any of this review's outcomes so meta-analysis was not possible.Neither of the studies reported on the primary outcomes of interest in this review: maternal morbidity (febrile illness, respiratory tract infection, diarrhoea), adverse effects of micronutrients within three days of receiving the supplement, infant mortality (defined as a child dying before completing the first year of age).One study reported qualitatively on maternal anaemia (a secondary outcome of this review) - the study found that multiple-micronutrient supplementation was effective for recuperating from anaemia but there were no data for inclusion in our analyses. Maternal satisfaction was not reported in the included studies. Similarly, none of this review's infant secondary outcomes were reported in the included studies: clinical micronutrient deficiency; morbidity episodes (febrile illness, respiratory tract infection, diarrhoea, other), adverse effects of micronutrients within three days of receiving the supplement. We found no evidence to quantitatively assess the effectiveness of multiple-micronutrient supplementation in improving health outcomes in mother and baby. The results of this review are limited by the small numbers of studies available, small sample sizes and the studies not reporting on the outcomes of interest in this review. There is no evidence to evaluate potential adverse effects of multiple-micronutrient supplements, particularly excess dosages.There is a need for high-quality studies to assess the effectiveness and safety of multiple-micronutrient supplementation for breastfeeding women for improving outcomes for the mother and her baby. Further research should focus on whether multiple-micronutrient supplementation during lactation compared with none, a placebo or supplementation with fewer than two micronutrients is beneficial to maternal and infant health outcomes. Future studies should collect data on outcomes beyond micronutrient concentrations, for example: maternal and infant morbidity, adverse effects, maternal satisfaction, the risks of excess supplementation, and potential adverse interactions between the micronutrients and the other outcomes. This would help to bridge the gap between research on intermediary outcomes and health outcomes in order to develop sound policy in this field. Future studies could more precisely assess a variety of multiple-micronutrient combinations and different dosages and look at how these affect maternal and infant health outcomes. Larger studies with longer follow-up would improve the quality of studies and provide stronger evidence. In most of the included studies, bias could not be adequately assessed due to lack of information, therefore attention should be given to adequate methods of randomisation and allocation concealment, adequate methods of blinding of the participants, providers and the outcome assessors to improve the methodological quality of studies in this field.

Quality Measurements in Radiology: A Systematic Review of the Literature and Survey of Radiology Benefit Management Groups.

PubMed

Narayan, Anand; Cinelli, Christina; Carrino, John A; Nagy, Paul; Coresh, Josef; Riese, Victoria G; Durand, Daniel J

2015-11-01

As the US health care system transitions toward value-based reimbursement, there is an increasing need for metrics to quantify health care quality. Within radiology, many quality metrics are in use, and still more have been proposed, but there have been limited attempts to systematically inventory these measures and classify them using a standard framework. The purpose of this study was to develop an exhaustive inventory of public and private sector imaging quality metrics classified according to the classic Donabedian framework (structure, process, and outcome). A systematic review was performed in which eligibility criteria included published articles (from 2000 onward) from multiple databases. Studies were double-read, with discrepancies resolved by consensus. For the radiology benefit management group (RBM) survey, the six known companies nationally were surveyed. Outcome measures were organized on the basis of standard categories (structure, process, and outcome) and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy yielded 1,816 citations; review yielded 110 reports (29 included for final analysis). Three of six RBMs (50%) responded to the survey; the websites of the other RBMs were searched for additional metrics. Seventy-five unique metrics were reported: 35 structure (46%), 20 outcome (27%), and 20 process (27%) metrics. For RBMs, 35 metrics were reported: 27 structure (77%), 4 process (11%), and 4 outcome (11%) metrics. The most commonly cited structure, process, and outcome metrics included ACR accreditation (37%), ACR Appropriateness Criteria (85%), and peer review (95%), respectively. Imaging quality metrics are more likely to be structural (46%) than process (27%) or outcome (27%) based (P < .05). As national value-based reimbursement programs increasingly emphasize outcome-based metrics, radiologists must keep pace by developing the data infrastructure required to collect outcome-based quality metrics. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

The Long-Term Conditions Questionnaire: conceptual framework and item development.

PubMed

Peters, Michele; Potter, Caroline M; Kelly, Laura; Hunter, Cheryl; Gibbons, Elizabeth; Jenkinson, Crispin; Coulter, Angela; Forder, Julien; Towers, Ann-Marie; A'Court, Christine; Fitzpatrick, Ray

2016-01-01

To identify the main issues of importance when living with long-term conditions to refine a conceptual framework for informing the item development of a patient-reported outcome measure for long-term conditions. Semi-structured qualitative interviews (n=48) were conducted with people living with at least one long-term condition. Participants were recruited through primary care. The interviews were transcribed verbatim and analyzed by thematic analysis. The analysis served to refine the conceptual framework, based on reviews of the literature and stakeholder consultations, for developing candidate items for a new measure for long-term conditions. Three main organizing concepts were identified: impact of long-term conditions, experience of services and support, and self-care. The findings helped to refine a conceptual framework, leading to the development of 23 items that represent issues of importance in long-term conditions. The 23 candidate items formed the first draft of the measure, currently named the Long-Term Conditions Questionnaire. The aim of this study was to refine the conceptual framework and develop items for a patient-reported outcome measure for long-term conditions, including single and multiple morbidities and physical and mental health conditions. Qualitative interviews identified the key themes for assessing outcomes in long-term conditions, and these underpinned the development of the initial draft of the measure. These initial items will undergo cognitive testing to refine the items prior to further validation in a survey.

Relationship between admissions committee review and student performance in medical school and internship.

PubMed

Gilliland, William R; Dong, Ting; Artino, Anthony R; Waechter, Donna M; Cruess, David F; DeZee, Kent J; McManigle, John E; Durning, Steven J

2012-09-01

To investigate the association between tertiary reviewer (admissions committee member) comments and medical students' performance during medical school and into internship. We collected data from seven year-groups (1993-1999) and coded tertiary reviewer comments into 14 themes. We then conducted an exploratory factor analysis to reduce the dimensions of the themes (excluding the Overall impression theme). Subsequently, we performed Pearson correlation analyses and multiple linear regression analysis to examine the relationship between the factors and seven outcome measures: medical school preclinical grade point average (GPA), medical school clinical GPA, cumulative medical school GPA, U.S. Medical Licensing Examination Step 1 and 2 scores, and scores on a program director's evaluation measuring intern professionalism and expertise. We extracted seven factors from the 13 themes and found small-to-moderate, significant correlations between the factors, the Overall impression theme, and the outcome measures. In particular, positive comments on Test and Maturity were associated with higher U.S. Medical Licensing Examination Step 1 and 2 scores. Negative comments on Interview and Recommendations were associated with lower ratings of professionalism during internship. Comments on Overall impression were significantly associated with all the outcome measures. Tertiary reviewer comments were weakly associated with performance in medical school and internship. Compared with positive comments, negative comments had stronger associations with medical school and internship performance measures.

The association of maternal vitamin D status with infant birth outcomes, postnatal growth and adiposity in the first 2 years of life in a multi-ethnic Asian population: the Growing Up in Singapore Towards healthy Outcomes (GUSTO) cohort study.

PubMed

Ong, Yi Lin; Quah, Phaik Ling; Tint, Mya Thway; Aris, Izzuddin M; Chen, Ling Wei; van Dam, Rob M; Heppe, Denise; Saw, Seang-Mei; Godfrey, Keith M; Gluckman, Peter D; Chong, Yap Seng; Yap, Fabian; Lee, Yung Seng; Foong-Fong Chong, Mary

2016-08-01

Maternal vitamin D status during pregnancy has been associated with infant birth and postnatal growth outcomes, but reported findings have been inconsistent, especially in relation to postnatal growth and adiposity outcomes. In a mother-offspring cohort in Singapore, maternal plasma vitamin D was measured between 26 and 28 weeks of gestation, and anthropometric measurements were obtained from singleton offspring during the first 2 years of life with 3-month follow-up intervals to examine birth, growth and adiposity outcomes. Associations were analysed using multivariable linear regression. Of a total of 910 mothers, 13·2 % were vitamin D deficient (<50 nmol/l) and 26·5 % were insufficient (50-75 nmol/l). After adjustment for potential confounders and multiple testing, no statistically significant associations were observed between maternal vitamin D status and any of the birth outcomes - small for gestational age (OR 1·00; 95 % CI 0·56, 1·79) and pre-term birth (OR 1·16; 95 % CI 0·64, 2·11) - growth outcomes - weight-for-age z-scores, length-for-age z-scores, circumferences of the head, abdomen and mid-arm at birth or postnatally - and adiposity outcomes - BMI, and skinfold thickness (triceps, biceps and subscapular) at birth or postnatally. Maternal vitamin D status in pregnancy did not influence infant birth outcomes, postnatal growth and adiposity outcomes in this cohort, perhaps due to the low prevalence (1·6 % of the cohort) of severe maternal vitamin D deficiency (defined as of <30·0 nmol/l) in our population.

Organisational stressors, coping, and outcomes in competitive sport.

PubMed

Arnold, Rachel; Fletcher, David; Daniels, Kevin

2017-04-01

Organisational stressors are associated with positive and negative outcomes in extant literature; however, little is known about which demands predict which outcomes. Extant theory and literature also suggests that coping style may influence an individual's resilience or vulnerability to stressors and, subsequently, their psychological responses and outcomes. The purpose of this study was, therefore, to examine the main effects of organisational stressors and coping styles on various outcomes (e.g., positive and negative affect, performance satisfaction). Sport performers (n = 414) completed measures of organisational stressors, coping styles, positive and negative affect, and performance satisfaction. Multiple regression analyses revealed positive relationships of both goals and development stressors (duration and intensity) and team and culture stressors (frequency and intensity) on negative affect. Furthermore, problem-focused coping was positively related to positive affect, and emotion-focused coping was positively related to negative affect. This study furthers theoretical knowledge regarding the associations that both organisational stressors (and their dimensions) and coping styles can have with various outcomes, and practical understanding regarding the optimal design of stress management interventions.

Visualization of Global Disease Burden for the Optimization of Patient Management and Treatment.

PubMed

Schlee, Winfried; Hall, Deborah A; Edvall, Niklas K; Langguth, Berthold; Canlon, Barbara; Cederroth, Christopher R

2017-01-01

The assessment and treatment of complex disorders is challenged by the multiple domains and instruments used to evaluate clinical outcome. With the large number of assessment tools typically used in complex disorders comes the challenge of obtaining an integrative view of disease status to further evaluate treatment outcome both at the individual level and at the group level. Radar plots appear as an attractive visual tool to display multivariate data on a two-dimensional graphical illustration. Here, we describe the use of radar plots for the visualization of disease characteristics applied in the context of tinnitus, a complex and heterogeneous condition, the treatment of which has shown mixed success. Data from two different cohorts, the Swedish Tinnitus Outreach Project (STOP) and the Tinnitus Research Initiative (TRI) database, were used. STOP is a population-based cohort where cross-sectional data from 1,223 non-tinnitus and 933 tinnitus subjects were analyzed. By contrast, the TRI contained data from 571 patients who underwent various treatments and whose Clinical Global Impression (CGI) score was accessible to infer treatment outcome. In the latter, 34,560 permutations were tested to evaluate whether a particular ordering of the instruments could reflect better the treatment outcome measured with the CGI. Radar plots confirmed that tinnitus subtypes such as occasional and chronic tinnitus from the STOP cohort could be strikingly different, and helped appreciate a gender bias in tinnitus severity. Radar plots with greater surface areas were consistent with greater burden, and enabled a rapid appreciation of the global distress associated with tinnitus in patients categorized according to tinnitus severity. Permutations in the arrangement of instruments allowed to identify a configuration with minimal variance and maximized surface difference between CGI groups from the TRI database, thus affording a means of optimally evaluating the outcomes in individual patients. We anticipate such a tool to become a starting point for more sophisticated measures in clinical outcomes, applicable not only in the context of tinnitus but also in other complex diseases where the integration of multiple variables is needed for a comprehensive evaluation of treatment response.

Association Between Executive Function and Problematic Adolescent Driving.

PubMed

Pope, Caitlin N; Ross, Lesley A; Stavrinos, Despina

Motor vehicle collisions (MVCs) are one of the leading causes of injury and death for adolescents. Driving is a complex activity that is highly reliant on executive function (EF) to safely navigate through the environment. Little research has examined the efficacy of using self-reported EF measures for assessing adolescent driving risk. This study examined the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire and performance-based EF tasks as potential predictors of problematic driving outcomes in adolescents. Forty-six adolescent drivers completed the (1) BRIEF, (2) Trail Making Test, (3) Backwards Digit Span, and (4) self-report on 3 problematic driving outcomes: the number of times of having been pulled over by a police officer, the number of tickets issued, and the number of MVCs. Greater self-reported difficulty with planning and organization was associated with greater odds of having a MVC, whereas inhibition difficulties were associated with greater odds of receiving a ticket. Greater self-reported difficulty across multiple BRIEF subscales was associated with greater odds of being pulled over. Overall findings indicated that the BRIEF, an ecological measure of EF, showed significant association with self-reported problematic driving outcomes in adolescents. No relationship was found between performance-based EF measures and self-reported driving outcomes. The BRIEF could offer unique and quick insight into problematic driving behavior and potentially be an indicator of driving risk in adolescent drivers during clinical evaluations.

Competing Biases in Mental Arithmetic: When Division Is More and Multiplication Is Less.

PubMed

Shaki, Samuel; Fischer, Martin H

2017-01-01

Mental arithmetic exhibits various biases. Among those is a tendency to overestimate addition and to underestimate subtraction outcomes. Does such "operational momentum" (OM) also affect multiplication and division? Twenty-six adults produced lines whose lengths corresponded to the correct outcomes of multiplication and division problems shown in symbolic format. We found a reliable tendency to over-estimate division outcomes, i.e., reverse OM. We suggest that anchoring on the first operand (a tendency to use this number as a reference for further quantitative reasoning) contributes to cognitive biases in mental arithmetic.