Econometrics in outcomes research: the use of instrumental variables.

PubMed

Newhouse, J P; McClellan, M

1998-01-01

We describe an econometric technique, instrumental variables, that can be useful in estimating the effectiveness of clinical treatments in situations when a controlled trial has not or cannot be done. This technique relies upon the existence of one or more variables that induce substantial variation in the treatment variable but have no direct effect on the outcome variable of interest. We illustrate the use of the technique with an application to aggressive treatment of acute myocardial infarction in the elderly.

Intercenter Differences in Bronchopulmonary Dysplasia or Death Among Very Low Birth Weight Infants

PubMed Central

Walsh, Michele; Bobashev, Georgiy; Das, Abhik; Levine, Burton; Carlo, Waldemar A.; Higgins, Rosemary D.

2011-01-01

OBJECTIVES: To determine (1) the magnitude of clustering of bronchopulmonary dysplasia (36 weeks) or death (the outcome) across centers of the Eunice Kennedy Shriver National Institute of Child and Human Development National Research Network, (2) the infant-level variables associated with the outcome and estimate their clustering, and (3) the center-specific practices associated with the differences and build predictive models. METHODS: Data on neonates with a birth weight of <1250 g from the cluster-randomized benchmarking trial were used to determine the magnitude of clustering of the outcome according to alternating logistic regression by using pairwise odds ratio and predictive modeling. Clinical variables associated with the outcome were identified by using multivariate analysis. The magnitude of clustering was then evaluated after correction for infant-level variables. Predictive models were developed by using center-specific and infant-level variables for data from 2001 2004 and projected to 2006. RESULTS: In 2001–2004, clustering of bronchopulmonary dysplasia/death was significant (pairwise odds ratio: 1.3; P < .001) and increased in 2006 (pairwise odds ratio: 1.6; overall incidence: 52%; range across centers: 32%–74%); center rates were relatively stable over time. Variables that varied according to center and were associated with increased risk of outcome included lower body temperature at NICU admission, use of prophylactic indomethacin, specific drug therapy on day 1, and lack of endotracheal intubation. Center differences remained significant even after correction for clustered variables. CONCLUSION: Bronchopulmonary dysplasia/death rates demonstrated moderate clustering according to center. Clinical variables associated with the outcome were also clustered. Center differences after correction of clustered variables indicate presence of as-yet unmeasured center variables. PMID:21149431

The prognostic value of standardized reference values for speckle-tracking global longitudinal strain in hypertrophic cardiomyopathy.

PubMed

Hartlage, Gregory R; Kim, Jonathan H; Strickland, Patrick T; Cheng, Alan C; Ghasemzadeh, Nima; Pernetz, Maria A; Clements, Stephen D; Williams, B Robinson

2015-03-01

Speckle-tracking left ventricular global longitudinal strain (GLS) assessment may provide substantial prognostic information for hypertrophic cardiomyopathy (HCM) patients. Reference values for GLS have been recently published. We aimed to evaluate the prognostic value of standardized reference values for GLS in HCM patients. An analysis of HCM clinic patients who underwent GLS was performed. GLS was defined as normal (more negative or equal to -16%) and abnormal (less negative than -16%) based on recently published reference values. Patients were followed for a composite of events including heart failure hospitalization, sustained ventricular arrhythmia, and all-cause death. The power of GLS to predict outcomes was assessed relative to traditional clinical and echocardiographic variables present in HCM. 79 HCM patients were followed for a median of 22 months (interquartile range 9-30 months) after imaging. During follow-up, 15 patients (19%) met the primary outcome. Abnormal GLS was the only echocardiographic variable independently predictive of the primary outcome [multivariate Hazard ratio 5.05 (95% confidence interval 1.09-23.4, p = 0.038)]. When combined with traditional clinical variables, abnormal GLS remained independently predictive of the primary outcome [multivariate Hazard ratio 5.31 (95 % confidence interval 1.18-24, p = 0.030)]. In a model including the strongest clinical and echocardiographic predictors of the primary outcome, abnormal GLS demonstrated significant incremental benefit for risk stratification [net reclassification improvement 0.75 (95 % confidence interval 0.21-1.23, p < 0.0001)]. Abnormal GLS is an independent predictor of adverse outcomes in HCM patients. Standardized use of GLS may provide significant incremental value over traditional variables for risk stratification.

BIOCHEMICAL HOMEOSTASIS AND BODY GROWTH ARE RELIABLE END POINTS IN CLINICAL NUTRITION TRIALS

USDA-ARS?s Scientific Manuscript database

Studies of biochemical homeostasis and/or body growth have been included as outcome variables in most nutrition trials in paediatric patients. Moreover, these outcome variables have provided important insights into the nutrient requirements of infants and children, and continue to do so. Examples ...

Outcome Measures Used in Clinical Trials for Behçet Syndrome: A Systematic Review

PubMed Central

Hatemi, Gulen; Merkel, Peter A.; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z.; Yazici, Hasan

2015-01-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology. PMID:24488418

Outcome measures used in clinical trials for Behçet syndrome: a systematic review.

PubMed

Hatemi, Gulen; Merkel, Peter A; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z; Yazici, Hasan

2014-03-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology.

Histologic prognosticators in feline osteosarcoma: a comparison with phenotypically similar canine osteosarcoma.

PubMed

Dimopoulou, Maria; Kirpensteijn, Jolle; Moens, Hester; Kik, Marja

2008-07-01

To investigate the histologic characteristics of feline osteosarcoma (OS) and compare the histologic data with phenotypically comparable canine OS. The effects of histologic and clinical variables on survival statistics were evaluated. Retrospective study. Cats (n=62) and dogs (22). Medical records of 62 cats with OS were reviewed for clinically relevant data. Clinical outcome was obtained by telephone interview. Histologic characteristics of OS were classified using a standardized grading system. Histologic characteristics in 22 feline skeletal OS were compared with 22 canine skeletal OS of identical location and subtype. Prognostic variables for clinical outcome were determined using multivariate analysis. Feline OS was characterized by moderate to abundant cellular pleomorphism, low mitotic index, small to moderate amounts of matrix, high cellularity, and a moderate amount of necrosis. There was no significant difference between histologic variables in feline and canine OS. Histologic grade, surgery, and mitotic index significantly influenced clinical outcome as determined by multivariate analysis. Tumor invasion into vessels was not identified as a significant prognosticator. Feline and canine skeletal OS have similar histologic but different prognostic characteristics. Prognosis for cats with OS is related to histologic grade and mitotic index of the tumor.

Nottingham Prognostic Index Plus (NPI+): a modern clinical decision making tool in breast cancer.

PubMed

Rakha, E A; Soria, D; Green, A R; Lemetre, C; Powe, D G; Nolan, C C; Garibaldi, J M; Ball, G; Ellis, I O

2014-04-02

Current management of breast cancer (BC) relies on risk stratification based on well-defined clinicopathologic factors. Global gene expression profiling studies have demonstrated that BC comprises distinct molecular classes with clinical relevance. In this study, we hypothesised that molecular features of BC are a key driver of tumour behaviour and when coupled with a novel and bespoke application of established clinicopathologic prognostic variables can predict both clinical outcome and relevant therapeutic options more accurately than existing methods. In the current study, a comprehensive panel of biomarkers with relevance to BC was applied to a large and well-characterised series of BC, using immunohistochemistry and different multivariate clustering techniques, to identify the key molecular classes. Subsequently, each class was further stratified using a set of well-defined prognostic clinicopathologic variables. These variables were combined in formulae to prognostically stratify different molecular classes, collectively known as the Nottingham Prognostic Index Plus (NPI+). The NPI+ was then used to predict outcome in the different molecular classes. Seven core molecular classes were identified using a selective panel of 10 biomarkers. Incorporation of clinicopathologic variables in a second-stage analysis resulted in identification of distinct prognostic groups within each molecular class (NPI+). Outcome analysis showed that using the bespoke NPI formulae for each biological BC class provides improved patient outcome stratification superior to the traditional NPI. This study provides proof-of-principle evidence for the use of NPI+ in supporting improved individualised clinical decision making.

Dose response explorer: an integrated open-source tool for exploring and modelling radiotherapy dose volume outcome relationships

NASA Astrophysics Data System (ADS)

El Naqa, I.; Suneja, G.; Lindsay, P. E.; Hope, A. J.; Alaly, J. R.; Vicic, M.; Bradley, J. D.; Apte, A.; Deasy, J. O.

2006-11-01

Radiotherapy treatment outcome models are a complicated function of treatment, clinical and biological factors. Our objective is to provide clinicians and scientists with an accurate, flexible and user-friendly software tool to explore radiotherapy outcomes data and build statistical tumour control or normal tissue complications models. The software tool, called the dose response explorer system (DREES), is based on Matlab, and uses a named-field structure array data type. DREES/Matlab in combination with another open-source tool (CERR) provides an environment for analysing treatment outcomes. DREES provides many radiotherapy outcome modelling features, including (1) fitting of analytical normal tissue complication probability (NTCP) and tumour control probability (TCP) models, (2) combined modelling of multiple dose-volume variables (e.g., mean dose, max dose, etc) and clinical factors (age, gender, stage, etc) using multi-term regression modelling, (3) manual or automated selection of logistic or actuarial model variables using bootstrap statistical resampling, (4) estimation of uncertainty in model parameters, (5) performance assessment of univariate and multivariate analyses using Spearman's rank correlation and chi-square statistics, boxplots, nomograms, Kaplan-Meier survival plots, and receiver operating characteristics curves, and (6) graphical capabilities to visualize NTCP or TCP prediction versus selected variable models using various plots. DREES provides clinical researchers with a tool customized for radiotherapy outcome modelling. DREES is freely distributed. We expect to continue developing DREES based on user feedback.

Personalized treatment planning with a model of radiation therapy outcomes for use in multiobjective optimization of IMRT plans for prostate cancer.

PubMed

Smith, Wade P; Kim, Minsun; Holdsworth, Clay; Liao, Jay; Phillips, Mark H

2016-03-11

To build a new treatment planning approach that extends beyond radiation transport and IMRT optimization by modeling the radiation therapy process and prognostic indicators for more outcome-focused decision making. An in-house treatment planning system was modified to include multiobjective inverse planning, a probabilistic outcome model, and a multi-attribute decision aid. A genetic algorithm generated a set of plans embodying trade-offs between the separate objectives. An influence diagram network modeled the radiation therapy process of prostate cancer using expert opinion, results of clinical trials, and published research. A Markov model calculated a quality adjusted life expectancy (QALE), which was the endpoint for ranking plans. The Multiobjective Evolutionary Algorithm (MOEA) was designed to produce an approximation of the Pareto Front representing optimal tradeoffs for IMRT plans. Prognostic information from the dosimetrics of the plans, and from patient-specific clinical variables were combined by the influence diagram. QALEs were calculated for each plan for each set of patient characteristics. Sensitivity analyses were conducted to explore changes in outcomes for variations in patient characteristics and dosimetric variables. The model calculated life expectancies that were in agreement with an independent clinical study. The radiation therapy model proposed has integrated a number of different physical, biological and clinical models into a more comprehensive model. It illustrates a number of the critical aspects of treatment planning that can be improved and represents a more detailed description of the therapy process. A Markov model was implemented to provide a stronger connection between dosimetric variables and clinical outcomes and could provide a practical, quantitative method for making difficult clinical decisions.

Age of depressed patient does not affect clinical outcome in collaborative care management.

PubMed

Angstman, Kurt B; MacLaughlin, Kathy L; Rasmussen, Norman H; DeJesus, Ramona S; Katzelnick, David J

2011-09-01

Clinical response and remission for the treatment of depression has been shown to be improved utilizing collaborative care management (CCM). Prior studies have indicated that the presence of mental health comorbidities noted by self-rated screening tools at the intake for CCM are associated with worsening outcomes; few have examined directly the impact of age on clinical response and remission. The hypothesis was that when controlling for other mental health and demographic variables, the age of the patient at implementation of CCM does not significantly impact clinical outcome, and that CCM shows consistent efficacy across the adult age spectrum. We performed a retrospective chart analysis of a cohort of 574 patients with a clinical diagnosis of major depression (not dysthymia) treated in CCM who had 6 months of follow-up data. Using the age group as a categorical variable in logistic regression models demonstrated that while maintaining control of all other variables, age grouping remained a nonsignificant predictor of clinical response (P ≥ 0.1842) and remission (P ≥ 0.1919) after 6 months of treatment. In both models, a lower Generalized Anxiety Disorder-7 score and a negative Mood Disorder Questionnaire score were predictive of clinical response and remission. However, the initial Patient Health Questionnaire-9 score was a statistically significant predictor only for clinical remission (P = 0.0094), not for response (P = 0.0645), at 6 months. In a subset (n = 295) of the study cohort, clinical remission at 12 months was also not associated with age grouping (P ≥ 0.3355). The variables that were predictive of remission at 12 months were the presence of clinical remission at 6 months (odds ratio [OR], 7.4820; confidence interval [CI], 3.9301-14.0389; P < 0.0001), clinical response (with persistent symptoms) (OR, 2.7722; CI, 1.1950-6.4313; P = 0.0176), and a lower initial Patient Health Questionnaire-9 score (OR, 0.9121; CI, 0.8475-0.9816; P = 0.0140). Our study suggests that using CCM for depression treatment may transcend age-related differences in depression and result in positive outcomes regardless of age.

Anxiety Disorders in Caucasian and African American Children: A Comparison of Clinical Characteristics, Treatment Process Variables, and Treatment Outcomes.

PubMed

Gordon-Hollingsworth, Arlene T; Becker, Emily M; Ginsburg, Golda S; Keeton, Courtney; Compton, Scott N; Birmaher, Boris B; Sakolsky, Dara J; Piacentini, John; Albano, Anne M; Kendall, Philip C; Suveg, Cynthia M; March, John S

2015-10-01

This study examined racial differences in anxious youth using data from the Child/Adolescent Anxiety Multimodal Study (CAMS) [1]. Specifically, the study aims addressed whether African American (n = 44) versus Caucasian (n = 359) children varied on (1) baseline clinical characteristics, (2) treatment process variables, and (3) treatment outcomes. Participants were ages 7-17 and met DSM-IV-TR criteria for generalized anxiety disorder, social phobia, and/or separation anxiety disorder. Baseline data, as well as outcome data at 12 and 24 weeks, were obtained by independent evaluators. Weekly treatment process variables were collected by therapists. Results indicated no racial differences on baseline clinical characteristics. However, African American participants attended fewer psychotherapy and pharmacotherapy sessions, and were rated by therapists as less involved and compliant, in addition to showing lower mastery of CBT. Once these and other demographic factors were accounted for, race was not a significant predictor of response, remission, or relapse. Implications of these findings suggest African American and Caucasian youth are more similar than different with respect to the manifestations of anxiety and differences in outcomes are likely due to treatment barriers to session attendance and therapist engagement.

Anxiety Disorders in Caucasian and African American Children: A Comparison of Clinical Characteristics, Treatment Process Variables, and Treatment Outcomes

PubMed Central

Gordon-Hollingsworth, Arlene T.; Becker, Emily M.; Keeton, Courtney; Compton, Scott N.; Birmaher, Boris B.; Sakolsky, Dara J.; Piacentini, John; Albano, Anne M.; Kendall, Philip C.; Suveg, Cynthia M.; March, John S.

2014-01-01

This study examined racial differences in anxious youth using data from the Child/Adolescent Anxiety Multimodal Study (CAMS) [1]. Specifically, the study aims addressed whether African American (n = 44) versus Caucasian (n = 359) children varied on (1) baseline clinical characteristics, (2) treatment process variables, and (3) treatment outcomes. Participants were ages 7–17 and met DSM-IV-TR criteria for generalized anxiety disorder, social phobia, and/or separation anxiety disorder. Baseline data, as well as outcome data at 12 and 24 weeks, were obtained by independent evaluators. Weekly treatment process variables were collected by therapists. Results indicated no racial differences on baseline clinical characteristics. However, African American participants attended fewer psychotherapy and pharmacotherapy sessions, and were rated by therapists as less involved and compliant, in addition to showing lower mastery of CBT. Once these and other demographic factors were accounted for, race was not a significant predictor of response, remission, or relapse. Implications of these findings suggest African American and Caucasian youth are more similar than different with respect to the manifestations of anxiety and differences in outcomes are likely due to treatment barriers to session attendance and therapist engagement. PMID:25293650

Stent Retriever Thrombectomy in Different Thrombus Locations of Anterior Cerebral Circulation

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

Protto, Sara; Sillanpää, Niko, E-mail: niko.sillanpaa@pshp.fi; Pienimäki, Juha-Pekka

BackgroundMechanical thrombectomy (MT) is a safe and efficient treatment for acute ischemic stroke in patients with proximal anterior occlusion and large penumbra. We evaluated the technical and clinical success of MT in relation to the location of the occlusion (internal carotid artery, M1 and M2 segments of the middle cerebral artery).MethodsWe prospectively reviewed 130 patients of whom 105 met the inclusion criteria. Baseline clinical, procedural and imaging variables, technical outcome (TICI, thrombolysis in cerebral infarction), 24 h imaging outcome and three-month clinical outcome (mRS, modified Rankin Scale) were recorded. Differences between the groups were studied with statistical tests according to themore » type of the variable.ResultsThere were 37, 46 and 22 patients in the internal carotid artery (ICA), M1 and M2 groups, respectively. TICI 2b or 3 was achieved in 92 cases (88 %) with a non-significant trend towards a better recanalization outcome in the ICA and M1 groups. Overall, 57 of the 105 patients (55 %) experienced favorable clinical outcome (mRS ≤ 2) with no significant differences between the groups. Excellent outcome (mRS ≤ 1) was seen in 40 patients (39 %) and there proportionally more patients with excellent outcome in the ICA and M1 groups (ICA: 44 %, M1: 41 %, M2: 23 % of patients, p = 0.22).ConclusionsThere were no statistically significant differences in the technical or clinical outcomes between the different sites of occlusion (ICA, M1 or M2). There was a non-significant trend towards achieving excellent clinical outcome (3-month mRS ≤ 1) more often and better recanalization results in the two more proximal locations.« less

Use of reflectance spectrophotometry to predict the response of port wine stains to pulsed dye laser.

PubMed

Halachmi, Shlomit; Azaria, Ron; Inbar, Roy; Ad-El, Dean; Lapidoth, Moshe

2014-01-01

Reflectance spectroscopy can be used to quantitate subtle differences in color. We applied a portable reflectance spectrometer to determine its utility in the evaluation of pulsed dye laser treatment of port wine stains (PWS) and in prediction of clinical outcome, in a prospective study. Forty-eight patients with PWS underwent one to nine pulsed dye laser treatments. Patient age and skin color as well as PWS surface area, anatomic location, and color were recorded. Pretreatment spectrophotometric measurements were performed. The subjective clinical results of treatment and the quantitative spectrophotometry results were evaluated by two independent teams, and the findings were correlated. The impact of the clinical characteristics on the response to treatment was assessed as well. Patients with excellent to good clinical results of laser treatments had pretreatment spectrophotometric measurements which differed by more than 10%, whereas patients with fair to poor results had spectrophotometric measurements with a difference of of less than 10%. The correlation between the spectrophotometric results and the clinical outcome was 73% (p < 0.01). The impact of the other clinical variables on outcome agreed with the findings in the literature. Spectrophotometry has a higher correlation with clinical outcome and a better predictive value than other nonmeasurable, nonquantitative, dependent variables.

The distribution of outcomes research papers across clinical journals.

PubMed

Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

2011-06-01

This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.

Social gradients in periodontal diseases among adolescents.

PubMed

López, Rodrigo; Fernández, Olaya; Baelum, Vibeke

2006-06-01

To investigate the association between socioeconomic position and periodontal diseases among adolescents. Data were obtained from 9203 Chilean high school students. Clinical examinations included direct recordings of clinical attachment level and the necrotizing ulcerative gingival lesions. Students answered a questionnaire on various dimensions of socioeconomic position. Seven periodontal outcomes were analyzed. Logistic regression analyses were used to identify socioeconomic variables associated with the periodontal outcomes. The occurrence of all periodontal outcomes investigated followed social gradients, and paternal income and parental education were the most influential variables. The study demonstrates the existence of significant social gradients in periodontal diseases already among adolescents. This is worrying, and indicates a new potential for further insight into the mechanisms of periodontal disease causation.

Influence of Body Mass Index and Albumin on Perioperative Morbidity and Clinical Outcomes in Resected Pancreatic Adenocarcinoma

PubMed Central

Hendifar, Andrew; Osipov, Arsen; Khanuja, Jasleen; Nissen, Nicholas; Naziri, Jason; Yang, Wensha; Li, Quanlin; Tuli, Richard

2016-01-01

Obesity is a known risk factor for PDA and recent reports suggest obesity has a negative impact on clinical outcomes in patients with PDA. Pretreatment body mass index (BMI) and serum albumin (SA) have been shown to be associated with worse overall survival in patients with advanced and metastatic PDA. However, minimal data exists on the impact of BMI and SA on perioperative and long-term clinical outcomes in patients with early-stage resected PDA. Herein, we report on the impact of these variables on perioperative clinical outcomes, overall survival (OS) and disease free survival (DFS) in patients with resected PDA. With IRB approval, we evaluated 1,545 patients with PDA treated at a single institution from 2007–2013 and identified 106 patients who underwent upfront resection with curative intent. BMI and SA were calculated preoperatively and at the time of last clinical evaluation. Influence of preoperative BMI, SA, change in either variable, and influence of other clinical and pathologic variables on perioperative morbidity and mortality was assessed. The impact of these variables on DFS and OS was assessed with cox regression modeling and ANOVA. Actuarial estimates for DFS and OS were calculated using Kaplan-Meier methods. Median follow up time was 16 months (3–89). Mean age was 68 years. Median survival was 14 months (3–65) and median time to recurrence was 11 months (1–79). Length of hospital stay was associated with BMI (p = .023), change in BMI (p = .003) and SA (p = .004). Post-operative transfusion rate was associated with SA (p = .021). There was a strong correlation between BMI change and positive margin (p = .04) and lymph node status (p = .01). On multivariate analysis, change in SA (p = .03) and node positivity (p = .008) were associated with decreased DFS. Additionally, preoperative SA (p = .023), node positivity (p = .026) and poor differentiation (p = .045) were associated with worse OS on multivariate analysis. Low preoperative SA was associated with worse DFS and OS in patients with resected PDA. Lower BMI and SA were associated with longer post-operative hospital stay. Our study is one of the first to describe how pre-operative BMI and SA and post-operative changes in these variables impact clinical and perioperative outcomes. This data supports nutritional status and weight loss as predictors of outcome in resected pancreatic cancer patients and warrants further prospective investigation. PMID:27015568

Influence of Body Mass Index and Albumin on Perioperative Morbidity and Clinical Outcomes in Resected Pancreatic Adenocarcinoma.

PubMed

Hendifar, Andrew; Osipov, Arsen; Khanuja, Jasleen; Nissen, Nicholas; Naziri, Jason; Yang, Wensha; Li, Quanlin; Tuli, Richard

2016-01-01

Obesity is a known risk factor for PDA and recent reports suggest obesity has a negative impact on clinical outcomes in patients with PDA. Pretreatment body mass index (BMI) and serum albumin (SA) have been shown to be associated with worse overall survival in patients with advanced and metastatic PDA. However, minimal data exists on the impact of BMI and SA on perioperative and long-term clinical outcomes in patients with early-stage resected PDA. Herein, we report on the impact of these variables on perioperative clinical outcomes, overall survival (OS) and disease free survival (DFS) in patients with resected PDA. With IRB approval, we evaluated 1,545 patients with PDA treated at a single institution from 2007-2013 and identified 106 patients who underwent upfront resection with curative intent. BMI and SA were calculated preoperatively and at the time of last clinical evaluation. Influence of preoperative BMI, SA, change in either variable, and influence of other clinical and pathologic variables on perioperative morbidity and mortality was assessed. The impact of these variables on DFS and OS was assessed with cox regression modeling and ANOVA. Actuarial estimates for DFS and OS were calculated using Kaplan-Meier methods. Median follow up time was 16 months (3-89). Mean age was 68 years. Median survival was 14 months (3-65) and median time to recurrence was 11 months (1-79). Length of hospital stay was associated with BMI (p = .023), change in BMI (p = .003) and SA (p = .004). Post-operative transfusion rate was associated with SA (p = .021). There was a strong correlation between BMI change and positive margin (p = .04) and lymph node status (p = .01). On multivariate analysis, change in SA (p = .03) and node positivity (p = .008) were associated with decreased DFS. Additionally, preoperative SA (p = .023), node positivity (p = .026) and poor differentiation (p = .045) were associated with worse OS on multivariate analysis. Low preoperative SA was associated with worse DFS and OS in patients with resected PDA. Lower BMI and SA were associated with longer post-operative hospital stay. Our study is one of the first to describe how pre-operative BMI and SA and post-operative changes in these variables impact clinical and perioperative outcomes. This data supports nutritional status and weight loss as predictors of outcome in resected pancreatic cancer patients and warrants further prospective investigation.

Examination of Predictors and Moderators for Self-Help Treatments of Binge-Eating Disorder

ERIC Educational Resources Information Center

Masheb, Robin M.; Grilo, Carlos M.

2008-01-01

Predictors and moderators of outcomes were examined in 75 overweight patients with binge-eating disorder (BED) who participated in a randomized clinical trial of guided self-help treatments. Age variables, psychiatric and personality disorder comorbidity, and clinical characteristics were tested as predictors and moderators of treatment outcomes.…

A Strategy to Use Soft Data Effectively in Randomized Controlled Clinical Trials.

ERIC Educational Resources Information Center

Kraemer, Helena Chmura; Thiemann, Sue

1989-01-01

Sees soft data, measures having substantial intrasubject variability due to errors of measurement or response inconsistency, as important measures of response in randomized clinical trials. Shows that using intensive design and slope of response on time as outcome measure maximizes sample retention and decreases within-group variability, thus…

Bias, Confounding, and Interaction: Lions and Tigers, and Bears, Oh My!

PubMed

Vetter, Thomas R; Mascha, Edward J

2017-09-01

Epidemiologists seek to make a valid inference about the causal effect between an exposure and a disease in a specific population, using representative sample data from a specific population. Clinical researchers likewise seek to make a valid inference about the association between an intervention and outcome(s) in a specific population, based upon their randomly collected, representative sample data. Both do so by using the available data about the sample variable to make a valid estimate about its corresponding or underlying, but unknown population parameter. Random error in an experiment can be due to the natural, periodic fluctuation or variation in the accuracy or precision of virtually any data sampling technique or health measurement tool or scale. In a clinical research study, random error can be due to not only innate human variability but also purely chance. Systematic error in an experiment arises from an innate flaw in the data sampling technique or measurement instrument. In the clinical research setting, systematic error is more commonly referred to as systematic bias. The most commonly encountered types of bias in anesthesia, perioperative, critical care, and pain medicine research include recall bias, observational bias (Hawthorne effect), attrition bias, misclassification or informational bias, and selection bias. A confounding variable is a factor associated with both the exposure of interest and the outcome of interest. A confounding variable (confounding factor or confounder) is a variable that correlates (positively or negatively) with both the exposure and outcome. Confounding is typically not an issue in a randomized trial because the randomized groups are sufficiently balanced on all potential confounding variables, both observed and nonobserved. However, confounding can be a major problem with any observational (nonrandomized) study. Ignoring confounding in an observational study will often result in a "distorted" or incorrect estimate of the association or treatment effect. Interaction among variables, also known as effect modification, exists when the effect of 1 explanatory variable on the outcome depends on the particular level or value of another explanatory variable. Bias and confounding are common potential explanations for statistically significant associations between exposure and outcome when the true relationship is noncausal. Understanding interactions is vital to proper interpretation of treatment effects. These complex concepts should be consistently and appropriately considered whenever one is not only designing but also analyzing and interpreting data from a randomized trial or observational study.

Cross-trial prediction of treatment outcome in depression: a machine learning approach.

PubMed

Chekroud, Adam Mourad; Zotti, Ryan Joseph; Shehzad, Zarrar; Gueorguieva, Ralitza; Johnson, Marcia K; Trivedi, Madhukar H; Cannon, Tyrone D; Krystal, John Harrison; Corlett, Philip Robert

2016-03-01

Antidepressant treatment efficacy is low, but might be improved by matching patients to interventions. At present, clinicians have no empirically validated mechanisms to assess whether a patient with depression will respond to a specific antidepressant. We aimed to develop an algorithm to assess whether patients will achieve symptomatic remission from a 12-week course of citalopram. We used patient-reported data from patients with depression (n=4041, with 1949 completers) from level 1 of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D; ClinicalTrials.gov, number NCT00021528) to identify variables that were most predictive of treatment outcome, and used these variables to train a machine-learning model to predict clinical remission. We externally validated the model in the escitalopram treatment group (n=151) of an independent clinical trial (Combining Medications to Enhance Depression Outcomes [COMED]; ClinicalTrials.gov, number NCT00590863). We identified 25 variables that were most predictive of treatment outcome from 164 patient-reportable variables, and used these to train the model. The model was internally cross-validated, and predicted outcomes in the STAR*D cohort with accuracy significantly above chance (64·6% [SD 3·2]; p<0·0001). The model was externally validated in the escitalopram treatment group (N=151) of COMED (accuracy 59·6%, p=0.043). The model also performed significantly above chance in a combined escitalopram-buproprion treatment group in COMED (n=134; accuracy 59·7%, p=0·023), but not in a combined venlafaxine-mirtazapine group (n=140; accuracy 51·4%, p=0·53), suggesting specificity of the model to underlying mechanisms. Building statistical models by mining existing clinical trial data can enable prospective identification of patients who are likely to respond to a specific antidepressant. Yale University. Copyright © 2016 Elsevier Ltd. All rights reserved.

Predictors and moderators of response to cognitive behavioral therapy and medication for the treatment of binge eating disorder.

PubMed

Grilo, Carlos M; Masheb, Robin M; Crosby, Ross D

2012-10-01

To examine predictors and moderators of response to cognitive behavioral therapy (CBT) and medication treatments for binge-eating disorder (BED). 108 BED patients in a randomized double-blind placebo-controlled trial testing CBT and fluoxetine treatments were assessed prior, throughout, and posttreatment. Demographic factors, psychiatric and personality disorder comorbidity, eating disorder psychopathology, psychological features, and 2 subtyping methods (negative affect, overvaluation of shape/weight) were tested as predictors and moderators for the primary outcome of remission from binge eating and 4 secondary dimensional outcomes (binge-eating frequency, eating disorder psychopathology, depression, and body mass index). Mixed-effects models analyzed all available data for each outcome variable. In each model, effects for baseline value and treatment were included with tests of both prediction and moderator effects. Several demographic and clinical variables significantly predicted and/or moderated outcomes. One demographic variable signaled a statistical advantage for medication only (younger participants had greater binge-eating reductions), whereas several demographic and clinical variables (lower self-esteem, negative affect, and overvaluation of shape/weight) signaled better improvements if receiving CBT. Overvaluation was the most salient predictor/moderator of outcomes. Overvaluation significantly predicted binge-eating remission (29% of participants with vs. 57% of participants without overvaluation remitted). Overvaluation was especially associated with lower remission rates if receiving medication only (10% vs. 42% for participants without overvaluation). Overvaluation moderated dimensional outcomes: Participants with overvaluation had significantly greater reductions in eating disorder psychopathology and depression levels if receiving CBT. Overvaluation predictor/moderator findings persisted after controlling for negative affect. Our findings have clinical utility for prescription of CBT and medication and implications for refinement of the BED diagnosis. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Predictors and Moderators of Response to Cognitive Behavioral Therapy and Medication for the Treatment of Binge Eating Disorder

PubMed Central

Grilo, Carlos. M.; Masheb, Robin M.; Crosby, Ross D.

2012-01-01

Objective To examine predictors and moderators of response to cognitive-behavioral therapy (CBT) and medication treatments for binge-eating disorder (BED). Method 108 BED patients in a randomized double-blind placebo-controlled trial testing CBT and fluoxetine treatments were assessed prior, throughout-, and post-treatment. Demographic factors, psychiatric and personality-disorder co-morbidity, eating-disorder psychopathology, psychological features, and two sub-typing methods (negative-affect, overvaluation of shape/weight) were tested as predictors and moderators for the primary outcome of remission from binge-eating and four secondary dimensional outcomes (binge-eating frequency, eating-disorder psychopathology, depression, and body mass index). Mixed-effects-models analyzed all available data for each outcome variable. In each model, effects for baseline value and treatment were included with tests of both prediction and moderator effects. Results Several demographic and clinical variables significantly predicted and/or moderated outcomes. One demographic variable signaled a statistical advantage for medication-only (younger participants had greater binge-eating reductions) whereas several demographic and clinical variables (lower self-esteem, negative-affect, and overvaluation of shape/weight) signaled better improvements if receiving CBT. Overvaluation was the most salient predictor/moderator of outcomes. Overvaluation significantly predicted binge-eating remission (29% of participants with versus 57% of participants without overvaluation remitted). Overvaluation was especially associated with lower remission rates if receiving medication-only (10% versus 42% for participants without overvaluation). Overvaluation moderated dimensional outcomes: participants with overvaluation had significantly greater reductions in eating-disorder psychopathology and depression levels if receiving CBT. Overvaluation predictor/moderator findings persisted after controlling for negative-affect. Conclusions Our findings have clinical utility for prescription of CBT and medication and implications for refinement of the BED diagnosis. PMID:22289130

Factors associated with poor functional outcome in bipolar disorder: sociodemographic, clinical, and neurocognitive variables.

PubMed

Sanchez-Moreno, J; Bonnin, C M; González-Pinto, A; Amann, B L; Solé, B; Balanzá-Martinez, V; Arango, C; Jiménez, E; Tabarés-Seisdedos, R; Garcia-Portilla, M P; Ibáñez, A; Crespo, J M; Ayuso-Mateos, J L; Martinez-Aran, A; Torrent, C; Vieta, E

2018-05-03

The current investigation aimed at studying the sociodemographic, clinical, and neuropsychological variables related to functional outcome in a sample of euthymic patients with bipolar disorder(BD) presenting moderate-severe levels of functional impairment. Two-hundred and thirty-nine participants with BD disorders and with Functioning Assessment Short Test(FAST) scores equal or above 18 were administered a clinical and diagnostic interview, and the administration of mood measure scales and a comprehensive neuropsychological battery. Analyses involved preliminary Pearson bivariate correlations to identify sociodemographic and clinical variables associated with the FAST total score. Regarding neuropsychological variables, a principal component analysis (PCA) was performed to group the variables in orthogonal factors. Finally, a hierarchical multiple regression was run. The best fitting model for the variables associated with functioning was a linear combination of gender, age, estimated IQ, Hamilton Depression Rating Scale (HAM-D), number of previous manic episodes, Factor 1 and Factor 2 extracted from the PCA. The model, including all these previous variables, explained up to 29.4% of the observed variance. Male gender, older age, lower premorbid IQ, subdepressive symptoms, higher number of manic episodes, and lower performance in verbal memory, working memory, verbal fluency, and processing speed were associated with lower functioning in patients with BD. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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.

A clinical return-to-work rule for patients with back pain.

PubMed

Dionne, Clermont E; Bourbonnais, Renée; Frémont, Pierre; Rossignol, Michel; Stock, Susan R; Larocque, Isabelle

2005-06-07

Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most, while helping reduce unnecessary interventions (and costs) among the others. This study was conducted to develop and validate clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care settings. This was a 2-year prospective cohort study conducted in 7 primary care settings in the Quebec City area. The study enrolled 1007 workers (participation, 68.4% of potential participants expected to be eligible) aged 18-64 years who consulted for nonspecific back pain associated with at least 1 day's absence from work. The majority (86%) completed 5 telephone interviews documenting a large array of variables. Clinical information was abstracted from the medical files. The outcome measure was "return to work in good health" at 2 years, a variable that combined patients' occupational status, functional limitations and recurrences of work absence. Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40% random sample of our study subjects, then validated on the rest. The best predictive model included 7 baseline variables (patient's recovery expectations, radiating pain, previous back surgery, pain intensity, frequent change of position because of back pain, irritability and bad temper, and difficulty sleeping) and was particularly efficient at identifying patients with no adverse occupational outcome (negative predictive value 78%- 94%). A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome.

A clinical return-to-work rule for patients with back pain

PubMed Central

Dionne, Clermont E.; Bourbonnais, Renée; Frémont, Pierre; Rossignol, Michel; Stock, Susan R.; Larocque, Isabelle

2005-01-01

Background Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most, while helping reduce unnecessary interventions (and costs) among the others. This study was conducted to develop and validate clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care settings. Methods This was a 2-year prospective cohort study conducted in 7 primary care settings in the Quebec City area. The study enrolled 1007 workers (participation, 68.4% of potential participants expected to be eligible) aged 18–64 years who consulted for nonspecific back pain associated with at least 1 day's absence from work. The majority (86%) completed 5 telephone interviews documenting a large array of variables. Clinical information was abstracted from the medical files. The outcome measure was “return to work in good health” at 2 years, a variable that combined patients' occupational status, functional limitations and recurrences of work absence. Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40% random sample of our study subjects, then validated on the rest. Results The best predictive model included 7 baseline variables (patient's recovery expectations, radiating pain, previous back surgery, pain intensity, frequent change of position because of back pain, irritability and bad temper, and difficulty sleeping) and was particularly efficient at identifying patients with no adverse occupational outcome (negative predictive value 78%– 94%). Interpretation A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome. PMID:15939915

A Bayesian prediction model between a biomarker and the clinical endpoint for dichotomous variables.

PubMed

Jiang, Zhiwei; Song, Yang; Shou, Qiong; Xia, Jielai; Wang, William

2014-12-20

Early biomarkers are helpful for predicting clinical endpoints and for evaluating efficacy in clinical trials even if the biomarker cannot replace clinical outcome as a surrogate. The building and evaluation of an association model between biomarkers and clinical outcomes are two equally important concerns regarding the prediction of clinical outcome. This paper is to address both issues in a Bayesian framework. A Bayesian meta-analytic approach is proposed to build a prediction model between the biomarker and clinical endpoint for dichotomous variables. Compared with other Bayesian methods, the proposed model only requires trial-level summary data of historical trials in model building. By using extensive simulations, we evaluate the link function and the application condition of the proposed Bayesian model under scenario (i) equal positive predictive value (PPV) and negative predictive value (NPV) and (ii) higher NPV and lower PPV. In the simulations, the patient-level data is generated to evaluate the meta-analytic model. PPV and NPV are employed to describe the patient-level relationship between the biomarker and the clinical outcome. The minimum number of historical trials to be included in building the model is also considered. It is seen from the simulations that the logit link function performs better than the odds and cloglog functions under both scenarios. PPV/NPV ≥0.5 for equal PPV and NPV, and PPV + NPV ≥1 for higher NPV and lower PPV are proposed in order to predict clinical outcome accurately and precisely when the proposed model is considered. Twenty historical trials are required to be included in model building when PPV and NPV are equal. For unequal PPV and NPV, the minimum number of historical trials for model building is proposed to be five. A hypothetical example shows an application of the proposed model in global drug development. The proposed Bayesian model is able to predict well the clinical endpoint from the observed biomarker data for dichotomous variables as long as the conditions are satisfied. It could be applied in drug development. But the practical problems in applications have to be studied in further research.

Relationships between milk culture results and treatment for clinical mastitis or culling in Norwegian dairy cattle.

PubMed

Reksen, O; Sølverød, L; Branscum, A J; Osterås, O

2006-08-01

In quarter milk samples from 2,492 randomly sampled cows that were selected without regard to their current or previous udder health status, the relationships between the following outcome variables were studied: treatment of clinical mastitis; the joint event of either treatment or culling for mastitis; culling for all reasons; culling specifically for mastitis; and the covariates of positive milk culture for Staphylococcus aureus, Streptococcus spp., and coagulase-negative Staphylococcus spp., or other pathogens, or of negative culture for mastitis pathogens. Microbiological diagnoses were assigned at the cow level, and altogether 3,075 diagnoses were related to the outcome variables. The relation between the absence of pathogens and rich (>1,500 cfu/mL of milk) or sparse (

Patient satisfaction with psychotropic drugs: sensitivity to change and relationship to clinical status, quality-of-life, compliance and effectiveness of treatment. Results from a nation-wide 6-month prospective study.

PubMed

Gasquet, Isabelle; Tcherny-Lessenot, Stéphanie; Lépine, Jean-Pierre; Falissard, Bruno

2006-12-01

To see if patient satisfaction with psychotropics (PSP) could be used as a patient-oriented outcome variable in the evaluation of PSP drugs in clinical epidemiological studies, relationships between PSP, clinical status, QoL, compliance and the type of antipsychotic were analyzed. Elements of validation of PSP were also assessed. In a 6-month prospective study, 933 schizophrenic outpatients with initiation or change to their antipsychotic treatment were enrolled. Psychiatrists completed five CGI-SCH scales (positive, negative, cognitive, depressive and global), hospitalization, compliance, and prescription variables. Patients completed PSP, EuroQoL scales, sexual function and compliance variables. A satisfactory structural equation model was obtained showing significant relationships PSP/compliance (coef.=0.16), QoL/PSP (coef.=0.37), clinical status/QoL (coef.=0.61), clinical status/compliance (coef.=0.09). Patients receiving olanzapine were more satisfied than patients receiving other atypicals (coef.=012) and had better clinical status than patients treated with typicals (coef.=0.08). Evolution of PSP was related to clinical status, QoL, and continuation of treatment (all P<001). Sensitivity to change of PSP was moderate (effect size=0.2). PSP produced consistent results in relation to validated outcome variables. However, a single-item measure was not sufficiently sensitive to change. Multi-item questionnaires evaluating different dimensions are needed.

Do ictal EEG characteristics predict treatment outcomes in schizophrenic patients undergoing electroconvulsive therapy?

PubMed

Simsek, Gulnihal Gokce; Zincir, Selma; Gulec, Huseyin; Eksioglu, Sevgin; Semiz, Umit Basar; Kurtulmus, Yasemin Sipka

2015-08-01

The aim of this study is to investigate the relationship between features of electroencephalography (EEG), including seizure time, energy threshold level and post-ictal suppression time, and clinical variables, including treatment outcomes and side-effects, among schizophrenia inpatients undergoing electroconvulsive therapy (ECT). This is a naturalistic follow-up study on schizophrenia patients, diagnosed using DSM-IV-TR criteria, treated by a psychosis inpatient service. All participants completed the Brief Psychiatric Rating Scale (BPRS), the Global Assessment of Functioning (GAF) scale, the Frontal Assessment Battery (FAB) and a Data Collection Form. Assessments were made before treatment, during ECT and after treatment. Statistically significant improvements in both clinical and cognitive outcome were noted after ECT in all patients. Predictors of improvement were sought by evaluating electrophysiological variables measured at three time points (after the third, fifth and seventh ECT sessions). Logistic regression analysis showed that clinical outcome/improvement did not differ by seizure duration, threshold energy level or post-ictal suppression time. We found that ictal EEG parameters measured at several ECT sessions did not predict clinical recovery/outcomes. This may be because our centre defensively engages in "very specific patient selection" when ECT is contemplated. ECT does not cause short-term cognitive functional impairment and indeed improves cognition, because symptoms of the schizophrenic episode are alleviated.

The impact of temperament and character inventory personality traits on long-term outcome of Roux-en-Y gastric bypass.

PubMed

Gordon, Pedro Caldana; Sallet, José Afonso; Sallet, Paulo Clemente

2014-10-01

A significant proportion of patients who undergo bariatric surgery fail to achieve enduring weight loss. Previous studies suggest that psychosocial variables affect postoperative outcome, although this subject is still considered unclear. The purpose of this study is to further investigate the impact of psychosocial variables on Roux-en-Y gastric bypass (RYGB) outcomes over long-term follow-up. Individuals eligible for bariatric surgery were evaluated using validated psychopathological scales and the Temperament and Character Inventory in a specialized clinic for bariatric treatment. Adult patients who had RYGB were selected for the study. Percent of excess weight loss (%EWL) was measured after surgery at 6 months, 1 year, 2 years, and on the last clinical observation. This study included 333 subjects who had RYGB. Before surgery, mean age was 35.4 years (±9.5) and mean BMI was 43.3 kg/m(2) (±4.8). Higher baseline age and BMI were associated with lower %EWL across endpoints, although this association diminished over time. Follow up at 2 years and on the last clinical observation demonstrated that lower scores on the persistence personality variable and lower body dissatisfaction before surgery predicted lower %EWL. Psychosocial variables and personality traits assessed during preoperative evaluation significantly predicted weight loss after bariatric surgery. Greater impact was observed in long-term follow-up at 2 years. These findings provide guidance in identifying patients at risk for worse outcomes and designing interventions to improve long-term weight loss.

A method for developing outcome measures in the clinical laboratory.

PubMed

Jones, J

1996-01-01

Measuring and reporting outcomes in health care is becoming more important for quality assessment, utilization assessment, accreditation standards, and negotiating contracts in managed care. How does one develop an outcome measure for the laboratory to assess the value of the services? A method is described which outlines seven steps in developing outcome measures for a laboratory service or process. These steps include the following: 1. Identify the process or service to be monitored for performance and outcome assessment. 2. If necessary, form an multidisciplinary team of laboratory staff, other department staff, physicians, and pathologists. 3. State the purpose of the test or service including a review of published data for the clinical pathological correlation. 4. Prepare a process cause and effect diagram including steps critical to the outcome. 5. Identify key process variables that contribute to positive or negative outcomes. 6. Identify outcome measures that are not process measures. 7. Develop an operational definition, identify data sources, and collect data. Examples, including a process cause and effect diagram, process variables, and outcome measures, are given using the Therapeutic Drug Monitoring service (TDM). A summary of conclusions and precautions for outcome measurement is then provided.

Examination of Predictors and Moderators for Self-help Treatments of Binge Eating Disorder

PubMed Central

Masheb, Robin M.; Grilo, Carlos M.

2008-01-01

Predictors and moderators of outcomes were examined in 75 overweight patients with binge eating disorder (BED) who participated in a randomized clinical trial of guided self-help treatments. Age variables, psychiatric and personality disorder comorbidity and clinical characteristics were tested as predictors and moderators of treatment outcomes. Current age and age of BED onset did not predict outcomes. Key dimensional outcomes (binge frequency, eating psychopathology, and negative affect) were predominately predicted, but not moderated, by their respective pretreatment levels. Presence of personality disorders, particularly Cluster C, predicted both post-treatment negative affect and eating disorder psychopathology. Negative affect, but not major depressive disorder, predicted attrition, and post-treatment negative affect and eating disorder psychopathology. Despite the prognostic significance of these findings for dimensional outcomes, none of the variables tested were predictive of binge remission (i.e., a categorical outcome). No moderator effects were found. The present study found poorer prognosis for patients with negative affect and personality disorders suggesting that treatment outcomes may be enhanced by attending to the cognitive and personality styles of these patients. PMID:18837607

Combining biological and psychosocial baseline variables did not improve prediction of outcome of a very-low-energy diet in a clinic referral population.

PubMed

Sumithran, P; Purcell, K; Kuyruk, S; Proietto, J; Prendergast, L A

2018-02-01

Consistent, strong predictors of obesity treatment outcomes have not been identified. It has been suggested that broadening the range of predictor variables examined may be valuable. We explored methods to predict outcomes of a very-low-energy diet (VLED)-based programme in a clinically comparable setting, using a wide array of pre-intervention biological and psychosocial participant data. A total of 61 women and 39 men (mean ± standard deviation [SD] body mass index: 39.8 ± 7.3 kg/m 2 ) underwent an 8-week VLED and 12-month follow-up. At baseline, participants underwent a blood test and assessment of psychological, social and behavioural factors previously associated with treatment outcomes. Logistic regression, linear discriminant analysis, decision trees and random forests were used to model outcomes from baseline variables. Of the 100 participants, 88 completed the VLED and 42 attended the Week 60 visit. Overall prediction rates for weight loss of ≥10% at weeks 8 and 60, and attrition at Week 60, using combined data were between 77.8 and 87.6% for logistic regression, and lower for other methods. When logistic regression analyses included only baseline demographic and anthropometric variables, prediction rates were 76.2-86.1%. In this population, considering a wide range of biological and psychosocial data did not improve outcome prediction compared to simply-obtained baseline characteristics. © 2017 World Obesity Federation.

Influence of Clinical Status on the Association Between Plasma Total and Unbound Bilirubin and Death or Adverse Neurodevelopmental Outcomes in Extremely Low Birth Weight Infants

PubMed Central

Oh, William; Stevenson, David K.; Tyson, Jon E.; Morris, Brenda H.; Ahlfors, Charles E.; Bender, G. Jesse; Wong, Ronald J.; Perritt, Rebecca; Vohr, Betty R.; Van Meurs, Krista P.; Vreman, Hendrik J.; Das, Abhik; Phelps, Dale L.; O’Shea, T. Michael; Higgins, Rosemary D.

2010-01-01

Objectives To assess the influence of clinical status on the association between total plasma bilirubin and unbound bilirubin on death or adverse neurodevelopmental outcomes at 18–22 months corrected age in extremely low birth weight infants. Method Total plasma biirubin and unbound biirubin were measured in 1,101 extremely low birth weight infants at 5±1 day of age. Clinical criteria were used to classify infants as clinically stable or unstable. Survivors were examined at 18–22 months corrected age by certified examiners. Outcome variables were death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death prior to follow-up. For all outcomes, the interaction between bilirubin variables and clinical status was assessed in logistic regression analyses adjusted for multiple risk factors. Results Regardless of clinical status, an increasing level of unbound bilirubin was associated with higher rates of death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss and death before follow-up. Total plasma bilirubin values were directly associated with death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death before follow-up in unstable infants, but not in stable infants. An inverse association between total plasma bilirubin and death or cerebral palsy was found in stable infants. Conclusions In extremely low birth weight infants, clinical status at 5 days of age affects the association between total plasma and unbound bilirubin and death or adverse neurodevelopmental outcomes at 18–22 months of corrected age. An increasing level of UB is associated a higher risk of death or adverse neurodevelopmental outcomes regardless of clinical status. Increasing levels of total plasma bilirubin are directly associated with increasing risk of death or adverse neurodevelopmental outcomes in unstable, but not in stable infants. PMID:20105142

Correlation of abdominopelvic computed tomography with clinical manifestations in methamphetamine body stuffers.

PubMed

Bahrami-Motlagh, Hooman; Hassanian-Moghaddam, Hossein; Zamini, Hedieh; Zamani, Nasim; Gachkar, Latif

2018-02-01

Little is known about methamphetamine body stuffers and correlation of clinical manifestations with imaging studies. Current study was done to determine abdominopelvic computed tomography findings and clinical manifestations in methamphetamine body stuffers. In an IRB-approved routine data base study, demographic characteristics, clinical findings, and CT results of 70 methamphetamine body stuffers were retrieved. According to the clinical manifestations, the patients were categorized into either benign- or severe-outcome group. Also, they were determined to have positive or negative CT results. In the group with positive results, number and place of the baggies were determined, as well. Results of the CT were compared between the two groups. Almost 43% of the patients had positive abdominopelvic CT results. Mean density of the packs was 176.2 ± 152.7 Hounsfield unit. Based on the clinical grounds, 57% of the patients were in the benign- and 33% were in the severe-outcome group. In the benign group, 45% of the patients had positive CTs while in the severe-risk group, this was 40% (p > 0.05). Except variables defined as severe outcome (seizure, intubation, creatinine level, aspartate aminotransferase level, creatine phosphokinase and troponin level), agitation, on-arrival pulse rate, lactate dehydrogenase, bicarbonate, base excess, loss of consciousness and hospitalization period were correlating factors. But in regression analysis, we could not find a significant variable that prognosticate severe outcome. It seems that there is no relationship between the CT findings and clinical manifestations of the methamphetamine body stuffers. Severe outcomes may be observed even in the face of negative CTs.

Biasogram: Visualization of Confounding Technical Bias in Gene Expression Data

PubMed Central

Krzystanek, Marcin; Szallasi, Zoltan; Eklund, Aron C.

2013-01-01

Gene expression profiles of clinical cohorts can be used to identify genes that are correlated with a clinical variable of interest such as patient outcome or response to a particular drug. However, expression measurements are susceptible to technical bias caused by variation in extraneous factors such as RNA quality and array hybridization conditions. If such technical bias is correlated with the clinical variable of interest, the likelihood of identifying false positive genes is increased. Here we describe a method to visualize an expression matrix as a projection of all genes onto a plane defined by a clinical variable and a technical nuisance variable. The resulting plot indicates the extent to which each gene is correlated with the clinical variable or the technical variable. We demonstrate this method by applying it to three clinical trial microarray data sets, one of which identified genes that may have been driven by a confounding technical variable. This approach can be used as a quality control step to identify data sets that are likely to yield false positive results. PMID:23613961

[Prescribing monitoring in clinical practice: from enlightened empiricism to rational strategies].

PubMed

Buclin, Thierry; Herzig, Lilli

2013-05-15

Monitoring of a medical condition is the periodic measurement of one or several physiological or biological variables to detect a signal regarding its clinical progression or its response to treatment. We distinguish different medical situations between diagnostic, clinical and therapeutic process to apply monitoring. Many clinical, variables can be used for monitoring, once their intrinsic properties (normal range, critical difference, kinetics, reactivity) and external validity (pathophysiological importance, predictive power for clinical outcomes) are established. A formal conceptualization of monitoring is being developed and should support the rational development of monitoring strategies and their validation through appropriate clinical trials.

Closed treatment of unilateral mandibular condyle fractures in adults: a systematic review.

PubMed

Rozeboom, A V J; Dubois, L; Bos, R R M; Spijker, R; de Lange, J

2017-04-01

Of all mandibular fractures, 25-35% are condylar. Many studies have focused on whether to treat such fractures via open or closed modalities. A uniform protocol for closed treatment is lacking, but such a protocol could ensure good clinical practice. The aims of this systematic review were to provide an overview of the published studies exclusively pertaining to closed treatment and to summarize the existing modalities for closed treatment and their clinical outcomes. Sixteen studies were selected for detailed analysis. The treatments given were highly variable, ranging from doing nothing to applying maxillomandibular fixation with stainless steel wires. The results of the different studies and the treatment modalities used were difficult to interpret; however no clear differences in the outcome measures were seen between the treatment modalities applied. Complications encountered after closed treatment included malocclusion, limited mouth opening, reduced range of motion, and persistent pain. Due to the heterogeneity between groups, high loss-to-follow-up, poor descriptions of the treatments given, and variability in outcome measurement methods, no clear associations between adverse outcomes and the treatments applied could be determined. This review suggests that due to the high level of methodological variability in the relevant studies published to date, there are currently no uniform standards for the closed treatment of condylar fractures that can be expected to yield good clinical results. The establishment of such standards could potentially improve treatment outcomes. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Measure of functional independence dominates discharge outcome prediction after inpatient rehabilitation for stroke.

PubMed

Brown, Allen W; Therneau, Terry M; Schultz, Billie A; Niewczyk, Paulette M; Granger, Carl V

2015-04-01

Identifying clinical data acquired at inpatient rehabilitation admission for stroke that accurately predict key outcomes at discharge could inform the development of customized plans of care to achieve favorable outcomes. The purpose of this analysis was to use a large comprehensive national data set to consider a wide range of clinical elements known at admission to identify those that predict key outcomes at rehabilitation discharge. Sample data were obtained from the Uniform Data System for Medical Rehabilitation data set with the diagnosis of stroke for the years 2005 through 2007. This data set includes demographic, administrative, and medical variables collected at admission and discharge and uses the FIM (functional independence measure) instrument to assess functional independence. Primary outcomes of interest were functional independence measure gain, length of stay, and discharge to home. The sample included 148,367 people (75% white; mean age, 70.6±13.1 years; 97% with ischemic stroke) admitted to inpatient rehabilitation a mean of 8.2±12 days after symptom onset. The total functional independence measure score, the functional independence measure motor subscore, and the case-mix group were equally the strongest predictors for any of the primary outcomes. The most clinically relevant 3-variable model used the functional independence measure motor subscore, age, and walking distance at admission (r(2)=0.107). No important additional effect for any other variable was detected when added to this model. This analysis shows that a measure of functional independence in motor performance and age at rehabilitation hospital admission for stroke are predominant predictors of outcome at discharge in a uniquely large US national data set. © 2015 American Heart Association, Inc.

Leg pain and psychological variables predict outcome 2-3 years after lumbar fusion surgery.

PubMed

Abbott, Allan D; Tyni-Lenné, Raija; Hedlund, Rune

2011-10-01

Prediction studies testing a thorough range of psychological variables in addition to demographic, work-related and clinical variables are lacking in lumbar fusion surgery research. This prospective cohort study aimed at examining predictions of functional disability, back pain and health-related quality of life (HRQOL) 2-3 years after lumbar fusion by regressing nonlinear relations in a multivariate predictive model of pre-surgical variables. Before and 2-3 years after lumbar fusion surgery, patients completed measures investigating demographics, work-related variables, clinical variables, functional self-efficacy, outcome expectancy, fear of movement/(re)injury, mental health and pain coping. Categorical regression with optimal scaling transformation, elastic net regularization and bootstrapping were used to investigate predictor variables and address predictive model validity. The most parsimonious and stable subset of pre-surgical predictor variables explained 41.6, 36.0 and 25.6% of the variance in functional disability, back pain intensity and HRQOL 2-3 years after lumbar fusion. Pre-surgical control over pain significantly predicted functional disability and HRQOL. Pre-surgical catastrophizing and leg pain intensity significantly predicted functional disability and back pain while the pre-surgical straight leg raise significantly predicted back pain. Post-operative psychomotor therapy also significantly predicted functional disability while pre-surgical outcome expectations significantly predicted HRQOL. For the median dichotomised classification of functional disability, back pain intensity and HRQOL levels 2-3 years post-surgery, the discriminative ability of the prediction models was of good quality. The results demonstrate the importance of pre-surgical psychological factors, leg pain intensity, straight leg raise and post-operative psychomotor therapy in the predictions of functional disability, back pain and HRQOL-related outcomes.

Variable mechanical ventilation

PubMed Central

Fontela, Paula Caitano; Prestes, Renata Bernardy; Forgiarini Jr., Luiz Alberto; Friedman, Gilberto

2017-01-01

Objective To review the literature on the use of variable mechanical ventilation and the main outcomes of this technique. Methods Search, selection, and analysis of all original articles on variable ventilation, without restriction on the period of publication and language, available in the electronic databases LILACS, MEDLINE®, and PubMed, by searching the terms "variable ventilation" OR "noisy ventilation" OR "biologically variable ventilation". Results A total of 36 studies were selected. Of these, 24 were original studies, including 21 experimental studies and three clinical studies. Conclusion Several experimental studies reported the beneficial effects of distinct variable ventilation strategies on lung function using different models of lung injury and healthy lungs. Variable ventilation seems to be a viable strategy for improving gas exchange and respiratory mechanics and preventing lung injury associated with mechanical ventilation. However, further clinical studies are necessary to assess the potential of variable ventilation strategies for the clinical improvement of patients undergoing mechanical ventilation. PMID:28444076

The CROWN initiative: journal editors invite researchers to develop core outcomes in women’s health

PubMed Central

2014-01-01

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a "core outcomes set" - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women's health have come together to support The CROWN (CoRe Outcomes in WomeN's health) Initiative. PMID:25048583

The CROWN initiative: journal editors invite researchers to develop core outcomes in women’s health

PubMed Central

2014-01-01

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a “core outcomes set” - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women’s health have come together to support The CROWN (CoRe Outcomes in WomeN’s health) Initiative. PMID:24957208

The CROWN Initiative: journal editors invite researchers to develop core outcomes in women’s health

PubMed Central

2014-01-01

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a "core outcomes set" - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women's health have come together to support The CROWN (CoRe Outcomes in WomeN's health) Initiative. PMID:25050130

The variable clinical presentation of tuberculosis otitis media and the importance of early detection.

PubMed

Abes, Generoso T; Abes, Franco Louie L B; Jamir, Joselito C

2011-06-01

Tuberculosis (TB) is a rare cause of otitis media. This study aims to increase awareness on the clinical presentation of TB otitis media and illustrate how early detection affects treatment outcome. Chart review of 12 patients (13 ears) from a tertiary hospital in Manila, Philippines, seen from 2004 to 2009. Clinical predictors of the disease were summarized. Clinical, radiologic, and audiometric outcomes after treatment were compared between treatment groups. The 5 otoscopic presentations were multiple perforations, single perforation with refractory otorrhea and exuberant granulation tissue formation, single perforation with minimal otorrhea and no granulation tissue formation, intact tympanic membrane with middle ear effusion, and intact tympanic membrane with tumorlike tissue in the middle ear. Clinical predictors of the disease were history of pulmonary TB, work-related contamination of the infection, positive purified protein derivative test, positive chest radiographic finding and intraoperative granulation tissue with cheesy material, and temporal bone computed tomographic scan findings. Patients who had no middle ear surgery showed significantly better clinical, radiologic, and audiometric outcomes than those who were diagnosed late and had more complicated surgical procedure. The clinical presentation of TB otitis media is variable. Early detection of the early forms entail less surgical intervention and favors better treatment results.

Predicting outcome in severe traumatic brain injury using a simple prognostic model.

PubMed

Sobuwa, Simpiwe; Hartzenberg, Henry Benjamin; Geduld, Heike; Uys, Corrie

2014-06-17

Several studies have made it possible to predict outcome in severe traumatic brain injury (TBI) making it beneficial as an aid for clinical decision-making in the emergency setting. However, reliable predictive models are lacking for resource-limited prehospital settings such as those in developing countries like South Africa. To develop a simple predictive model for severe TBI using clinical variables in a South African prehospital setting. All consecutive patients admitted at two level-one centres in Cape Town, South Africa, for severe TBI were included. A binary logistic regression model was used, which included three predictor variables: oxygen saturation (SpO₂), Glasgow Coma Scale (GCS) and pupil reactivity. The Glasgow Outcome Scale was used to assess outcome on hospital discharge. A total of 74.4% of the outcomes were correctly predicted by the logistic regression model. The model demonstrated SpO₂ (p=0.019), GCS (p=0.001) and pupil reactivity (p=0.002) as independently significant predictors of outcome in severe TBI. Odds ratios of a good outcome were 3.148 (SpO₂ ≥ 90%), 5.108 (GCS 6 - 8) and 4.405 (pupils bilaterally reactive). This model is potentially useful for effective predictions of outcome in severe TBI.

Clinical Value of Dorsal Medulla Oblongata Involvement Detected with Conventional MRI for Prediction of Outcome in Children with Enterovirus 71-related Brainstem Encephalitis.

PubMed

Liu, Kun; Zhou, Yongjin; Cui, Shihan; Song, Jiawen; Ye, Peipei; Xiang, Wei; Huang, Xiaoyan; Chen, Yiping; Yan, Zhihan; Ye, Xinjian

2018-04-05

Brainstem encephalitis is the most common neurologic complication after enterovirus 71 infection. The involvement of brainstem, especially the dorsal medulla oblongata, can cause severe sequelae or death in children with enterovirus 71 infection. We aimed to determine the prevalence of dorsal medulla oblongata involvement in children with enterovirus 71-related brainstem encephalitis (EBE) by using conventional MRI and to evaluate the value of dorsal medulla oblongata involvement in outcome prediction. 46 children with EBE were enrolled in the study. All subjects underwent a 1.5 Tesla MR examination of the brain. The disease distribution and clinical data were collected. Dichotomized outcomes (good versus poor) at longer than 6 months were available for 28 patients. Logistic regression was used to determine whether the MRI-confirmed dorsal medulla oblongata involvement resulted in improved clinical outcome prediction when compared with other location involvement. Of the 46 patients, 35 had MRI evidence of dorsal medulla oblongata involvement, 32 had pons involvement, 10 had midbrain involvement, and 7 had dentate nuclei involvement. Patients with dorsal medulla oblongata involvement or multiple area involvement were significantly more often in the poor outcome group than in the good outcome group. Logistic regression analysis showed that dorsal medulla oblongata involvement was the most significant single variable in outcome prediction (predictive accuracy, 90.5%), followed by multiple area involvement, age, and initial glasgow coma scale score. Dorsal medulla oblongata involvement on conventional MRI correlated significantly with poor outcomes in EBE children, improved outcome prediction when compared with other clinical and disease location variables, and was most predictive when combined with multiple area involvement, glasgow coma scale score and age.

Prognostic factors of a favorable outcome following a supervised exercise program for soldiers with sub-acute and chronic low back pain.

PubMed

Perron, Marc; Gendron, Chantal; Langevin, Pierre; Leblond, Jean; Roos, Marianne; Roy, Jean-Sébastien

2018-04-02

Low back pain (LBP) encompasses heterogeneous patients unlikely to respond to a unique treatment. Identifying sub-groups of LBP may help to improve treatment outcomes. This is a hypothesis-setting study designed to create a clinical prediction rule (CPR) that will predict favorable outcomes in soldiers with sub-acute and chronic LBP participating in a multi-station exercise program. Military members with LBP participated in a supervised program comprising 7 stations each consisting of exercises of increasing difficulty. Demographic, impairment and disability data were collected at baseline. The modified Oswestry Disability Index (ODI) was administered at baseline and following the 6-week program. An improvement of 50% in the initial ODI score was considered the reference standard to determine a favorable outcome. Univariate associations with favorable outcome were tested using chi-square or paired t-tests. Variables that showed between-group (favorable/unfavorable) differences were entered into a logistic regression after determining the sampling adequacy. Finally, continuous variables were dichotomized and the sensitivity, specificity and positive and negative likelihood ratios were determined for the model and for each variable. A sample of 85 participants was included in analyses. Five variables contributed to prediction of a favorable outcome: no pain in lying down (p = 0.017), no use of antidepressants (p = 0.061), FABQ work score < 22.5 (p = 0.061), fewer than 5 physiotherapy sessions before entering the program (p = 0.144) and less than 6 months' work restriction (p = 0.161). This model yielded a sensitivity of 0.78, specificity of 0.80, LR+ of 3.88, and LR- of 0.28. A 77.5% probability of favorable outcome can be predicted by the presence of more than three of the five variables, while an 80% probability of unfavorable outcome can be expected if only three or fewer variables are present. The use of prognostic factors may guide clinicians in identifying soldiers with LBP most likely to have a favorable outcome. Further validation studies are needed to determine if the variables identified in our study are treatment effect modifiers that can predict success following participation in the multi-station exercise program. ClinicalTrials.gov Identifier: NCT03464877 registered retrospectively on 14 March 2018.

Case file audit of Lidcombe program outcomes in a student-led stuttering clinic.

PubMed

McCulloch, Julia; Swift, Michelle C; Wagnitz, Bianca

2017-04-01

The current study aimed to benchmark clinical outcomes for preschool-aged clients (2;0-5;11 years old) that attended a student-led clinic and undertook the Lidcombe Program. A case file audit was undertaken for all preschool clients who attended the clinic between February 2008 and February 2013 and commenced the Lidcombe Program. Clients were grouped according to Stage 1 completion. A mixed ANOVA was used to test for differences between the groups in initial and final percentage syllables stuttered (%SS). Associations between case variable factors and treatment duration were investigated using Pearson correlations. Clients who completed Stage 1 had final %SS and severity rating (SR) scores comparable to the literature; however, the median Stage 1 duration was greater. Over half of the clients (57%) withdrew prior to completing Stage 1. These clients had a significantly higher %SS at final treatment session than their completing peers. Initial %SS and SR scores were the only case variables associated with treatment duration. Students can achieve the same short-term treatment outcomes for children who stutter using the Lidcombe Program as the current published literature; however, treatment duration is greater and may impact completion. Implications of this for clinical education are discussed.

Wound care clinical pathway: a conceptual model.

PubMed

Barr, J E; Cuzzell, J

1996-08-01

A clinical pathway is a written sequence of clinical processes or events that guides a patient with a defined problem toward an expected outcome. Clinical pathways are tools to assist with the cost-effective management of clinical outcomes related to specific problems or disease processes. The primary obstacles to developing clinical pathways for wound care are the chronic natures of some wounds and the many variables that can delay healing. The pathway introduced in this article was modeled upon the three phases of tissue repair: inflammatory, proliferative, and maturation. This physiology-based model allows clinicians to identify and monitor outcomes based on observable and measurable clinical parameters. The pathway design, which also includes educational and behavioral outcomes, allows the clinician to individualize the expected timeframe for outcome achievement based on individual patient criteria and expert judgement. Integral to the pathway are the "4P's" which help standardize the clinical processes by wound type: Protocols, Policies, Procedures, and Patient education tools. Four categories into which variances are categorized based on the cause of the deviation from the norm are patient, process/system, practitioner, and planning/discharge. Additional research is warranted to support the value of this clinical pathway in the clinical arena.

Intra-Gene DNA Methylation Variability Is a Clinically Independent Prognostic Marker in Women’s Cancers

PubMed Central

Bartlett, Thomas E.; Jones, Allison; Goode, Ellen L.; Fridley, Brooke L.; Cunningham, Julie M.; Berns, Els M. J. J.; Wik, Elisabeth; Salvesen, Helga B.; Davidson, Ben; Trope, Claes G.; Lambrechts, Sandrina; Vergote, Ignace; Widschwendter, Martin

2015-01-01

We introduce a novel per-gene measure of intra-gene DNA methylation variability (IGV) based on the Illumina Infinium HumanMethylation450 platform, which is prognostic independently of well-known predictors of clinical outcome. Using IGV, we derive a robust gene-panel prognostic signature for ovarian cancer (OC, n = 221), which validates in two independent data sets from Mayo Clinic (n = 198) and TCGA (n = 358), with significance of p = 0.004 in both sets. The OC prognostic signature gene-panel is comprised of four gene groups, which represent distinct biological processes. We show the IGV measurements of these gene groups are most likely a reflection of a mixture of intra-tumour heterogeneity and transcription factor (TF) binding/activity. IGV can be used to predict clinical outcome in patients individually, providing a surrogate read-out of hard-to-measure disease processes. PMID:26629914

Intra-Gene DNA Methylation Variability Is a Clinically Independent Prognostic Marker in Women's Cancers.

PubMed

Bartlett, Thomas E; Jones, Allison; Goode, Ellen L; Fridley, Brooke L; Cunningham, Julie M; Berns, Els M J J; Wik, Elisabeth; Salvesen, Helga B; Davidson, Ben; Trope, Claes G; Lambrechts, Sandrina; Vergote, Ignace; Widschwendter, Martin

2015-01-01

We introduce a novel per-gene measure of intra-gene DNA methylation variability (IGV) based on the Illumina Infinium HumanMethylation450 platform, which is prognostic independently of well-known predictors of clinical outcome. Using IGV, we derive a robust gene-panel prognostic signature for ovarian cancer (OC, n = 221), which validates in two independent data sets from Mayo Clinic (n = 198) and TCGA (n = 358), with significance of p = 0.004 in both sets. The OC prognostic signature gene-panel is comprised of four gene groups, which represent distinct biological processes. We show the IGV measurements of these gene groups are most likely a reflection of a mixture of intra-tumour heterogeneity and transcription factor (TF) binding/activity. IGV can be used to predict clinical outcome in patients individually, providing a surrogate read-out of hard-to-measure disease processes.

Seven basic dimensions of personality pathology and their clinical consequences: Are all personalities equally harmful?

PubMed

Vall, Gemma; Gutiérrez, Fernando; Peri, Josep M; Gárriz, Miguel; Ferraz, Liliana; Baillés, Eva; Obiols, Jordi E

2015-11-01

Dimensional pathology models are increasingly being accepted for the assessment of disordered personalities, but their ability to predict negative outcomes is yet to be studied. We examine the relative clinical impact of seven basic dimensions of personality pathology through their associations with a wide range of clinical outcomes. A sample of 960 outpatients was assessed through a 7-factor model integrating the Cloninger, the Livesley, and the DSM taxonomies. Thirty-six indicators of clinical outcome covering three areas - dissatisfaction, functional difficulties, and clinical severity - were also assessed. The unique contribution of each personality dimension to clinical outcome was estimated through multiple regressions. Overall, personality dimensions explained 17.6% of the variance of clinical outcome, but varied substantially in terms of their unique contributions. Negative Emotionality had the greatest impact in all areas, contributing 43.9% of the explained variance. The remaining dimensions led to idiosyncratic patterns of clinical outcomes but had a comparatively minor clinical impact. A certain effect was also found for combinations of dimensions such as Negative Emotionality × Impulsive Sensation Seeking, but most interactions were clinically irrelevant. Our findings suggest that the most relevant dimensions of personality pathology are associated with very different clinical consequences and levels of harmfulness. The relative clinical impact of seven basic dimensions of personality pathology is examined. Negative Emotionality (Neuroticism) is 6-14 times as harmful as other pathological dimensions. The remaining dimensions and their interactions have very specific and comparatively minor clinical consequences. We examine only a handful of clinical outcomes. Our results may not be generalizable to other clinical or life outcomes. Our variables are self-reported and hence susceptible to bias. Our design does not allow us to establish causal relationships between personality and clinical outcomes. © 2015 The British Psychological Society.

Ensemble survival tree models to reveal pairwise interactions of variables with time-to-events outcomes in low-dimensional setting

PubMed Central

Dazard, Jean-Eudes; Ishwaran, Hemant; Mehlotra, Rajeev; Weinberg, Aaron; Zimmerman, Peter

2018-01-01

Unraveling interactions among variables such as genetic, clinical, demographic and environmental factors is essential to understand the development of common and complex diseases. To increase the power to detect such variables interactions associated with clinical time-to-events outcomes, we borrowed established concepts from random survival forest (RSF) models. We introduce a novel RSF-based pairwise interaction estimator and derive a randomization method with bootstrap confidence intervals for inferring interaction significance. Using various linear and nonlinear time-to-events survival models in simulation studies, we first show the efficiency of our approach: true pairwise interaction-effects between variables are uncovered, while they may not be accompanied with their corresponding main-effects, and may not be detected by standard semi-parametric regression modeling and test statistics used in survival analysis. Moreover, using a RSF-based cross-validation scheme for generating prediction estimators, we show that informative predictors may be inferred. We applied our approach to an HIV cohort study recording key host gene polymorphisms and their association with HIV change of tropism or AIDS progression. Altogether, this shows how linear or nonlinear pairwise statistical interactions of variables may be efficiently detected with a predictive value in observational studies with time-to-event outcomes. PMID:29453930

Ensemble survival tree models to reveal pairwise interactions of variables with time-to-events outcomes in low-dimensional setting.

PubMed

Dazard, Jean-Eudes; Ishwaran, Hemant; Mehlotra, Rajeev; Weinberg, Aaron; Zimmerman, Peter

2018-02-17

Unraveling interactions among variables such as genetic, clinical, demographic and environmental factors is essential to understand the development of common and complex diseases. To increase the power to detect such variables interactions associated with clinical time-to-events outcomes, we borrowed established concepts from random survival forest (RSF) models. We introduce a novel RSF-based pairwise interaction estimator and derive a randomization method with bootstrap confidence intervals for inferring interaction significance. Using various linear and nonlinear time-to-events survival models in simulation studies, we first show the efficiency of our approach: true pairwise interaction-effects between variables are uncovered, while they may not be accompanied with their corresponding main-effects, and may not be detected by standard semi-parametric regression modeling and test statistics used in survival analysis. Moreover, using a RSF-based cross-validation scheme for generating prediction estimators, we show that informative predictors may be inferred. We applied our approach to an HIV cohort study recording key host gene polymorphisms and their association with HIV change of tropism or AIDS progression. Altogether, this shows how linear or nonlinear pairwise statistical interactions of variables may be efficiently detected with a predictive value in observational studies with time-to-event outcomes.

PREDICTING ADHERENCE TO TREATMENT FOR METHAMPHETAMINE DEPENDENCE FROM NEUROPSYCHOLOGICAL AND DRUG USE VARIABLES*

PubMed Central

Dean, Andy C.; London, Edythe D.; Sugar, Catherine A.; Kitchen, Christina M. R.; Swanson, Aimee-Noelle; Heinzerling, Keith G.; Kalechstein, Ari D.; Shoptaw, Steven

2009-01-01

Although some individuals who abuse methamphetamine have considerable cognitive deficits, no prior studies have examined whether neurocognitive functioning is associated with outcome of treatment for methamphetamine dependence. In an outpatient clinical trial of bupropion combined with cognitive behavioral therapy and contingency management (Shoptaw et al., 2008), 60 methamphetamine-dependent adults completed three tests of reaction time and working memory at baseline. Other variables that were collected at baseline included measures of drug use, mood/psychiatric functioning, employment, social context, legal status, and medical status. We evaluated the relative predictive value of all baseline measures for treatment outcome using Classification and Regression Trees (CART; Breiman, 1984), a nonparametric statistical technique that produces easily interpretable decision rules for classifying subjects that are particularly useful in clinical settings. Outcome measures were whether or not a participant completed the trial and whether or not most urine tests showed abstinence from methamphetamine abuse. Urine-verified methamphetamine abuse at the beginning of the study was the strongest predictor of treatment outcome; two psychosocial measures (e.g., nicotine dependence and Global Assessment of Functioning) also offered some predictive value. A few reaction time and working memory variables were related to treatment outcome, but these cognitive measures did not significantly aid prediction after adjusting for methamphetamine usage at the beginning of the study. On the basis of these findings, we recommend that research groups seeking to identify new predictors of treatment outcome compare the predictors to methamphetamine usage variables to assure that unique predictive power is attained. PMID:19608354

Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease.

PubMed

Lindholm, Daniel; Lindbäck, Johan; Armstrong, Paul W; Budaj, Andrzej; Cannon, Christopher P; Granger, Christopher B; Hagström, Emil; Held, Claes; Koenig, Wolfgang; Östlund, Ollie; Stewart, Ralph A H; Soffer, Joseph; White, Harvey D; de Winter, Robbert J; Steg, Philippe Gabriel; Siegbahn, Agneta; Kleber, Marcus E; Dressel, Alexander; Grammer, Tanja B; März, Winfried; Wallentin, Lars

2017-08-15

Currently, there is no generally accepted model to predict outcomes in stable coronary heart disease (CHD). This study evaluated and compared the prognostic value of biomarkers and clinical variables to develop a biomarker-based prediction model in patients with stable CHD. In a prospective, randomized trial cohort of 13,164 patients with stable CHD, we analyzed several candidate biomarkers and clinical variables and used multivariable Cox regression to develop a clinical prediction model based on the most important markers. The primary outcome was cardiovascular (CV) death, but model performance was also explored for other key outcomes. It was internally bootstrap validated, and externally validated in 1,547 patients in another study. During a median follow-up of 3.7 years, there were 591 cases of CV death. The 3 most important biomarkers were N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), and low-density lipoprotein cholesterol, where NT-proBNP and hs-cTnT had greater prognostic value than any other biomarker or clinical variable. The final prediction model included age (A), biomarkers (B) (NT-proBNP, hs-cTnT, and low-density lipoprotein cholesterol), and clinical variables (C) (smoking, diabetes mellitus, and peripheral arterial disease). This "ABC-CHD" model had high discriminatory ability for CV death (c-index 0.81 in derivation cohort, 0.78 in validation cohort), with adequate calibration in both cohorts. This model provided a robust tool for the prediction of CV death in patients with stable CHD. As it is based on a small number of readily available biomarkers and clinical factors, it can be widely employed to complement clinical assessment and guide management based on CV risk. (The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial [STABILITY]; NCT00799903). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Physiological and behavioral indices of emotion dysregulation as predictors of outcome from cognitive behavioral therapy and acceptance and commitment therapy for anxiety.

PubMed

Davies, Carolyn D; Niles, Andrea N; Pittig, Andre; Arch, Joanna J; Craske, Michelle G

2015-03-01

Identifying for whom and under what conditions a treatment is most effective is an essential step toward personalized medicine. The current study examined pre-treatment physiological and behavioral variables as predictors and moderators of outcome in a randomized clinical trial comparing cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) for anxiety disorders. Sixty individuals with a DSM-IV defined principal anxiety disorder completed 12 sessions of either CBT or ACT. Baseline physiological and behavioral variables were measured prior to entering treatment. Self-reported anxiety symptoms were assessed at pre-treatment, post-treatment, and 6- and 12-month follow-up from baseline. Higher pre-treatment heart rate variability was associated with worse outcome across ACT and CBT. ACT outperformed CBT for individuals with high behavioral avoidance. Subjective anxiety levels during laboratory tasks did not predict or moderate treatment outcome. Due to small sample sizes of each disorder, disorder-specific predictors were not tested. Future research should examine these predictors in larger samples and across other outcome variables. Lower heart rate variability was identified as a prognostic indicator of overall outcome, whereas high behavioral avoidance was identified as a prescriptive indicator of superior outcome from ACT versus CBT. Investigation of pre-treatment physiological and behavioral variables as predictors and moderators of outcome may help guide future treatment-matching efforts. Copyright © 2014 Elsevier Ltd. All rights reserved.

Homework compliance counts in cognitive-behavioral therapy.

PubMed

Lebeau, Richard T; Davies, Carolyn D; Culver, Najwa C; Craske, Michelle G

2013-01-01

Prior research has demonstrated that there is some association between treatment engagement and treatment outcome in behavioral therapy for anxiety disorders. However, many of these investigations have been limited by weak measurement of treatment engagement variables, failure to control for potentially important baseline variables, and failure to consider various treatment engagement variables simultaneously. The purpose of the present study is to examine the relationship between two treatment engagement variables (treatment expectancy and homework compliance) and the extent to which they predict improvement from cognitive-behavioral therapy (CBT) for anxiety disorders. 84 adults with a DSM-IV-defined principal anxiety disorder took part in up to 12 sessions of CBT or acceptance and commitment therapy. Pre- and post-treatment disorder severity was assessed using clinical severity ratings from a semi-structured diagnostic interview. Participants made ratings of treatment expectancy after the first session. Homework compliance was assessed each session by the treating clinician. Contrary to hypotheses, treatment expectancy and homework compliance were poorly correlated. Regression analyses revealed that homework compliance, but not treatment expectancy, predicted a significant portion of the variance in treatment outcome (10%). The present research suggests that although treatment expectation and homework compliance likely represent unique constructs of treatment engagement, homework compliance may be the more important treatment engagement variable for outcomes. The present research suggests that improvement of homework compliance has the potential to be a highly practical and effective way to improve clinical outcomes in CBT targeting anxiety disorders.

Teaching a Machine to Feel Postoperative Pain: Combining High-Dimensional Clinical Data with Machine Learning Algorithms to Forecast Acute Postoperative Pain

PubMed Central

Tighe, Patrick J.; Harle, Christopher A.; Hurley, Robert W.; Aytug, Haldun; Boezaart, Andre P.; Fillingim, Roger B.

2015-01-01

Background Given their ability to process highly dimensional datasets with hundreds of variables, machine learning algorithms may offer one solution to the vexing challenge of predicting postoperative pain. Methods Here, we report on the application of machine learning algorithms to predict postoperative pain outcomes in a retrospective cohort of 8071 surgical patients using 796 clinical variables. Five algorithms were compared in terms of their ability to forecast moderate to severe postoperative pain: Least Absolute Shrinkage and Selection Operator (LASSO), gradient-boosted decision tree, support vector machine, neural network, and k-nearest neighbor, with logistic regression included for baseline comparison. Results In forecasting moderate to severe postoperative pain for postoperative day (POD) 1, the LASSO algorithm, using all 796 variables, had the highest accuracy with an area under the receiver-operating curve (ROC) of 0.704. Next, the gradient-boosted decision tree had an ROC of 0.665 and the k-nearest neighbor algorithm had an ROC of 0.643. For POD 3, the LASSO algorithm, using all variables, again had the highest accuracy, with an ROC of 0.727. Logistic regression had a lower ROC of 0.5 for predicting pain outcomes on POD 1 and 3. Conclusions Machine learning algorithms, when combined with complex and heterogeneous data from electronic medical record systems, can forecast acute postoperative pain outcomes with accuracies similar to methods that rely only on variables specifically collected for pain outcome prediction. PMID:26031220

Liver Transplantation for Fulminant Hepatic Failure

PubMed Central

Farmer, Douglas G.; Anselmo, Dean M.; Ghobrial, R. Mark; Yersiz, Hasan; McDiarmid, Suzanne V.; Cao, Carlos; Weaver, Michael; Figueroa, Jesus; Khan, Khurram; Vargas, Jorge; Saab, Sammy; Han, Steven; Durazo, Francisco; Goldstein, Leonard; Holt, Curtis; Busuttil, Ronald W.

2003-01-01

Objective To analyze outcomes after liver transplantation (LT) in patients with fulminant hepatic failure (FHF) with emphasis on pretransplant variables that can potentially help predict posttransplant outcome. Summary Background Data FHF is a formidable clinical problem associated with a high mortality rate. While LT is the treatment of choice for irreversible FHF, few investigations have examined pretransplant variables that can potentially predict outcome after LT. Methods A retrospective review was undertaken of all patients undergoing LT for FHF at a single transplant center. The median follow-up was 41 months. Thirty-five variables were analyzed by univariate and multivariate analysis to determine their impact on patient and graft survival. Results Two hundred four patients (60% female, median age 20.2 years) required urgent LT for FHF. Before LT, the majority of patients were comatose (76%), on hemodialysis (16%), and ICU-bound. The 1- and 5-year survival rates were 73% and 67% (patient) and 63% and 57% (graft). The primary cause of patient death was sepsis, and the primary cause of graft failure was primary graft nonfunction. Univariate analysis of pre-LT variables revealed that 19 variables predicted survival. From these results, multivariate analysis determined that the serum creatinine was the single most important prognosticator of patient survival. Conclusions This study, representing one of the largest published series on LT for FHF, demonstrates a long-term survival of nearly 70% and develops a clinically applicable and readily measurable set of pretransplant factors that determine posttransplant outcome. PMID:12724633

Variable selection for distribution-free models for longitudinal zero-inflated count responses.

PubMed

Chen, Tian; Wu, Pan; Tang, Wan; Zhang, Hui; Feng, Changyong; Kowalski, Jeanne; Tu, Xin M

2016-07-20

Zero-inflated count outcomes arise quite often in research and practice. Parametric models such as the zero-inflated Poisson and zero-inflated negative binomial are widely used to model such responses. Like most parametric models, they are quite sensitive to departures from assumed distributions. Recently, new approaches have been proposed to provide distribution-free, or semi-parametric, alternatives. These methods extend the generalized estimating equations to provide robust inference for population mixtures defined by zero-inflated count outcomes. In this paper, we propose methods to extend smoothly clipped absolute deviation (SCAD)-based variable selection methods to these new models. Variable selection has been gaining popularity in modern clinical research studies, as determining differential treatment effects of interventions for different subgroups has become the norm, rather the exception, in the era of patent-centered outcome research. Such moderation analysis in general creates many explanatory variables in regression analysis, and the advantages of SCAD-based methods over their traditional counterparts render them a great choice for addressing this important and timely issues in clinical research. We illustrate the proposed approach with both simulated and real study data. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Differences in clinical presentation and pregnancy outcomes in antepartum preeclampsia and new-onset postpartum preeclampsia: Are these the same disorder?

PubMed

Vilchez, Gustavo; Hoyos, Luis R; Leon-Peters, Jocelyn; Lagos, Moraima; Argoti, Pedro

2016-11-01

New-onset postpartum preeclampsia is a poorly defined condition that accounts for a significant percentage of eclampsia cases. It is unclear whether new-onset postpartum preeclampsia is a different disorder from or belongs to the same spectrum of classic antepartum preeclampsia. The objective of this study was to compare the clinical presentation and pregnancy outcomes of antepartum preeclampsia and new-onset postpartum preeclampsia. A retrospective study including 92 patients with antepartum preeclampsia and 92 patients with new-onset postpartum preeclampsia was performed. Clinical presentation and pregnancy outcomes were compared. Chi-square test was used to analyze categorical variables, and independent t -test and Mann-Whitney U -test for numerical variables. P -values of <0.05 were used to indicate statistical signifi cance. Patients with antepartum preeclampsia and new-onset postpartum preeclampsia differ significantly in profile, symptoms at presentation, laboratory markers and pregnancy outcomes. New-onset postpartum preeclampsia has a distinct patient profile and clinical presentation than antepartum preeclampsia, suggesting they may represent different disorders. Characterization of a patient profile with increased risk of developing this condition will help clinicians to identify patients at risk and provide early and targeted interventions to decrease the morbidity associated with this condition.

Use of Admission Criteria to Predict Performance of Students in an Entry-Level Master's Program on Fieldwork Placements and in Academic Courses.

PubMed

Kirchner, G L; Stone, R G; Holm, M B

2001-01-01

The relationships among clinical outcomes, academic success, and predictors used to screen applicants for entrance into a Master in Occupational Therapy Program (MOT) were examined. The dependent variables were grade point average in occupational therapy courses (OT-GPA), client therapy outcomes at the clinic, and ratings of MOT students by Level II Fieldwork supervisors. Predictor variables included undergraduate GPA, scores on the Graduate Record Examination (GRE), and an essay. Both undergraduate GPA and scores on the GRE were found to predict OT-GPA. The analytical section of the GRE was also positively correlated with fieldwork supervisors' ratings of students.

Phase Synchronization in Electroencephalographic Recordings Prognosticates Outcome in Paediatric Coma

PubMed Central

Nenadovic, Vera; Perez Velazquez, Jose Luis; Hutchison, James Saunders

2014-01-01

Brain injury from trauma, cardiac arrest or stroke is the most important cause of death and acquired disability in the paediatric population. Due to the lifetime impact of brain injury, there is a need for methods to stratify patient risk and ultimately predict outcome. Early prognosis is fundamental to the implementation of interventions to improve recovery, but no clinical model as yet exists. Healthy physiology is associated with a relative high variability of physiologic signals in organ systems. This was first evaluated in heart rate variability research. Brain variability can be quantified through electroencephalographic (EEG) phase synchrony. We hypothesised that variability in brain signals from EEG recordings would correlate with patient outcome after brain injury. Lower variability in EEG phase synchronization, would be associated with poor patient prognosis. A retrospective study, spanning 10 years (2000–2010) analysed the scalp EEGs of children aged 1 month to 17 years in coma (Glasgow Coma Scale, GCS, <8) admitted to the paediatric critical care unit (PCCU) following brain injury from TBI, cardiac arrest or stroke. Phase synchrony of the EEGs was evaluated using the Hilbert transform and the variability of the phase synchrony calculated. Outcome was evaluated using the 6 point Paediatric Performance Category Score (PCPC) based on chart review at the time of hospital discharge. Outcome was dichotomized to good outcome (PCPC score 1 to 3) and poor outcome (PCPC score 4 to 6). Children who had a poor outcome following brain injury secondary to cardiac arrest, TBI or stroke, had a higher magnitude of synchrony (R index), a lower spatial complexity of the synchrony patterns and a lower temporal variability of the synchrony index values at 15 Hz when compared to those patients with a good outcome. PMID:24752289

A longitudinal investigation of children internationally adopted at school age.

PubMed

Helder, Emily J; Mulder, Elizabeth; Gunnoe, Marjorie Linder

2016-01-01

Most existing research on children adopted internationally has focused on those adopted as infants and toddlers. The current study longitudinally tracked several outcomes, including cognitive, behavioral, emotional, attachment, and family functioning, in 25 children who had been internationally adopted at school age (M = 7.7 years old at adoption, SD = 3.4, range = 4–15 years). We examined the incidence of clinically significant impairments, significant change in outcomes over the three study points, and variables that predicted outcomes over time. Clinically significant impairments in sustained attention, full-scale intelligence, reading, language, executive functioning, externalizing problems, and parenting stress were common, with language and executive functioning impairments present at higher levels in the current study compared with past research focusing on children adopted as infants and toddlers. Over the three study points, significant improvements across most cognitive areas and attachment functioning were observed, though significant worsening in executive functioning and internalizing problems was present. Adoptive family-specific variables, such as greater maternal education, smaller family size, a parenting approach that encouraged age-expected behaviors, home schooling, and being the sole adopted child in the family were associated with greater improvement across several cognitive outcomes. In contrast, decreased parenting stress was predicted by having multiple adopted children and smaller family sizes were associated with greater difficulties with executive functioning. Child-specific variables were also linked to outcomes, with girls displaying worse attachment and poorer cognitive performance and with less time in orphanage care resulting in greater adoption success. Implications for future research and clinical applications are discussed.

Sense of coherence and periodontal health outcomes.

PubMed

Cyrino, Renata Magalhães; Costa, Fernando Oliveira; Cortelli, José Roberto; Cortelli, Sheila Cavalca; Cota, Luís Otávio Miranda

2016-07-01

Sense of Coherence (SOC) has been associated with perceived oral health measures, but the contribution of SOC to clinical measures is still unclear. The aim of the present cross-sectional study was to evaluate the potential association between periodontal health outcomes, such as periodontal clinical parameters and perceived periodontal health, and SOC. The study sample comprised 276 individuals, aged 18-60 years, from Belo Horizonte, Brazil. Participants answered questionnaires covering sociodemographic variables, self-perceived periodontal health and SOC. Full-mouth periodontal examinations were performed. The sample was divided into three groups according to SOC score: (a) SOC1 = weak (24-46); (b) SOC2 = moderate (47-51); (c) SOC3 = strong (52-65). Multivariate analyses including appropriate logistic or linear regression models were performed to evaluate the association between periodontal health outcomes and biological, sociodemographic and behavioural variables. Perceived general oral health was associated with family income bracket (p = 0.010), smoking (p = 0.004), dental flossing (p = 0.017) and SOC (weak SOC: p = 0.005). Perceived gum disease and perceived periodontal disease were associated with SOC (weak SOC: p = 0.001 and p = 0.015, respectively). Overall, perceived periodontal health outcomes were associated with SOC. However, no association between clinical periodontal health outcomes and SOC were observed.

Surrogacy Assessment Using Principal Stratification and a Gaussian Copula Model

PubMed Central

Taylor, J.M.G.; Elliott, M.R.

2014-01-01

In clinical trials, a surrogate outcome (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Many methods of surrogacy validation rely on models for the conditional distribution of T given Z and S. However, S is a post-randomization variable, and unobserved, simultaneous predictors of S and T may exist, resulting in a non-causal interpretation. Frangakis and Rubin1 developed the concept of principal surrogacy, stratifying on the joint distribution of the surrogate marker under treatment and control to assess the association between the causal effects of treatment on the marker and the causal effects of treatment on the clinical outcome. Working within the principal surrogacy framework, we address the scenario of an ordinal categorical variable as a surrogate for a censored failure time true endpoint. A Gaussian copula model is used to model the joint distribution of the potential outcomes of T, given the potential outcomes of S. Because the proposed model cannot be fully identified from the data, we use a Bayesian estimation approach with prior distributions consistent with reasonable assumptions in the surrogacy assessment setting. The method is applied to data from a colorectal cancer clinical trial, previously analyzed by Burzykowski et al..2 PMID:24947559

Surrogacy assessment using principal stratification and a Gaussian copula model.

PubMed

Conlon, Asc; Taylor, Jmg; Elliott, M R

2017-02-01

In clinical trials, a surrogate outcome ( S) can be measured before the outcome of interest ( T) and may provide early information regarding the treatment ( Z) effect on T. Many methods of surrogacy validation rely on models for the conditional distribution of T given Z and S. However, S is a post-randomization variable, and unobserved, simultaneous predictors of S and T may exist, resulting in a non-causal interpretation. Frangakis and Rubin developed the concept of principal surrogacy, stratifying on the joint distribution of the surrogate marker under treatment and control to assess the association between the causal effects of treatment on the marker and the causal effects of treatment on the clinical outcome. Working within the principal surrogacy framework, we address the scenario of an ordinal categorical variable as a surrogate for a censored failure time true endpoint. A Gaussian copula model is used to model the joint distribution of the potential outcomes of T, given the potential outcomes of S. Because the proposed model cannot be fully identified from the data, we use a Bayesian estimation approach with prior distributions consistent with reasonable assumptions in the surrogacy assessment setting. The method is applied to data from a colorectal cancer clinical trial, previously analyzed by Burzykowski et al.

The power of the National Surgical Quality Improvement Program--achieving a zero pneumonia rate in general surgery patients.

PubMed

Fuchshuber, Pascal R; Greif, William; Tidwell, Chantal R; Klemm, Michael S; Frydel, Cheryl; Wali, Abdul; Rosas, Efren; Clopp, Molly P

2012-01-01

The National Surgical Quality Improvement Program (NSQIP) of the American College of Surgeons provides risk-adjusted surgical outcome measures for participating hospitals that can be used for performance improvement of surgical mortality and morbidity. A surgical clinical nurse reviewer collects 135 clinical variables including preoperative risk factors, intraoperative variables, and 30-day postoperative mortality and morbidity outcomes for patients undergoing major surgical procedures. A report on mortality and complications is prepared twice a year. This article summarizes briefly the history of NSQIP and how its report on surgical outcomes can be used for performance improvement within a hospital system. In particular, it describes how to drive performance improvement with NSQIP data using the example of postoperative respiratory complications--a major factor of postoperative mortality. In addition, this article explains the benefit of a collaborative of several participating NSQIP hospitals and describes how to develop a "playbook" on the basis of an outcome improvement project.

Use of social adaptability index to explain self-care and diabetes outcomes.

PubMed

Campbell, Jennifer A; Walker, Rebekah J; Smalls, Brittany L; Egede, Leonard E

2017-06-20

To examine whether the social adaptability index (SAI) alone or components of the index provide a better explanatory model for self-care and diabetes outcomes. Six hundred fifteen patients were recruited from two primary care settings. A series of multiple linear regression models were run to assess (1) associations between the SAI and diabetes self-care/outcomes, and (2) associations between individual SAI indicator variables and diabetes self-care/outcomes. Separate models were run for each self-care behavior and outcome. Two models were run for each dependent variable to compare associations with the SAI and components of the index. The SAI has a significant association with the mental component of quality of life (0.23, p < 0.01). In adjusted analyses, the SAI score did not have a significant association with any of the self-care behaviors. Individual components from the index had significant associations between self-care and multiple SAI indicator variables. Significant associations also exist between outcomes and the individual SAI indicators for education and employment. In this population, the SAI has low explanatory power and few significant associations with diabetes self-care/outcomes. While the use of a composite index to predict outcomes within a diabetes population would have high utility, particularly for clinical settings, this SAI lacks statistical and clinical significance in a representative diabetes population. Based on these results, the index does not provide a good model fit and masks the relationship of individual components to diabetes self-care and outcomes. These findings suggest that five items alone are not adequate to explain or predict outcomes for patients with type 2 diabetes.

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership

PubMed Central

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Abstract Objective Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. Methods A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Results Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. Conclusion A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. PMID:29069424

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership.

PubMed

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Mediation analysis in nursing research: a methodological review.

PubMed

Liu, Jianghong; Ulrich, Connie

2016-12-01

Mediation statistical models help clarify the relationship between independent predictor variables and dependent outcomes of interest by assessing the impact of third variables. This type of statistical analysis is applicable for many clinical nursing research questions, yet its use within nursing remains low. Indeed, mediational analyses may help nurse researchers develop more effective and accurate prevention and treatment programs as well as help bridge the gap between scientific knowledge and clinical practice. In addition, this statistical approach allows nurse researchers to ask - and answer - more meaningful and nuanced questions that extend beyond merely determining whether an outcome occurs. Therefore, the goal of this paper is to provide a brief tutorial on the use of mediational analyses in clinical nursing research by briefly introducing the technique and, through selected empirical examples from the nursing literature, demonstrating its applicability in advancing nursing science.

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.

A points-based algorithm for prognosticating clinical outcome of Chiari malformation Type I with syringomyelia: results from a predictive model analysis of 82 surgically managed adult patients.

PubMed

Thakar, Sumit; Sivaraju, Laxminadh; Jacob, Kuruthukulangara S; Arun, Aditya Atal; Aryan, Saritha; Mohan, Dilip; Sai Kiran, Narayanam Anantha; Hegde, Alangar S

2018-01-01

OBJECTIVE Although various predictors of postoperative outcome have been previously identified in patients with Chiari malformation Type I (CMI) with syringomyelia, there is no known algorithm for predicting a multifactorial outcome measure in this widely studied disorder. Using one of the largest preoperative variable arrays used so far in CMI research, the authors attempted to generate a formula for predicting postoperative outcome. METHODS Data from the clinical records of 82 symptomatic adult patients with CMI and altered hindbrain CSF flow who were managed with foramen magnum decompression, C-1 laminectomy, and duraplasty over an 8-year period were collected and analyzed. Various preoperative clinical and radiological variables in the 57 patients who formed the study cohort were assessed in a bivariate analysis to determine their ability to predict clinical outcome (as measured on the Chicago Chiari Outcome Scale [CCOS]) and the resolution of syrinx at the last follow-up. The variables that were significant in the bivariate analysis were further analyzed in a multiple linear regression analysis. Different regression models were tested, and the model with the best prediction of CCOS was identified and internally validated in a subcohort of 25 patients. RESULTS There was no correlation between CCOS score and syrinx resolution (p = 0.24) at a mean ± SD follow-up of 40.29 ± 10.36 months. Multiple linear regression analysis revealed that the presence of gait instability, obex position, and the M-line-fourth ventricle vertex (FVV) distance correlated with CCOS score, while the presence of motor deficits was associated with poor syrinx resolution (p ≤ 0.05). The algorithm generated from the regression model demonstrated good diagnostic accuracy (area under curve 0.81), with a score of more than 128 points demonstrating 100% specificity for clinical improvement (CCOS score of 11 or greater). The model had excellent reliability (κ = 0.85) and was validated with fair accuracy in the validation cohort (area under the curve 0.75). CONCLUSIONS The presence of gait imbalance and motor deficits independently predict worse clinical and radiological outcomes, respectively, after decompressive surgery for CMI with altered hindbrain CSF flow. Caudal displacement of the obex and a shorter M-line-FVV distance correlated with good CCOS scores, indicating that patients with a greater degree of hindbrain pathology respond better to surgery. The proposed points-based algorithm has good predictive value for postoperative multifactorial outcome in these patients.

Efficacy and toxicity differences in lung cancer populations in the era of clinical trials globalization: the 'common arm' approach.

PubMed

Mack, Philip C; Gandara, David R; Lara, Primo N

2012-12-01

Historically, notable variability has been observed in clinical trial outcomes between different regions and populations worldwide, even when employing the same cytotoxic regimen in lung cancer. These divergent results underscore the inherent challenges in interpreting trials conducted abroad and raise questions regarding the general applicability of transnational clinical trials. Various reasons have been postulated to account for these differences in efficacy and toxicity, including trial design, eligibility criteria, patient demographics and, perhaps most intriguingly, population-related pharmacogenomics. However, without methodology to control for such variables, these hypotheses remain largely untested. The authors previously developed the 'common arm' approach in order to directly compare efficacy and toxicity results of trials simultaneously performed in different countries. By standardizing clinical trial-associated variables such as treatment regimens (dose, schedule, and so on), eligibility, staging, response and toxicity criteria, this approach has the potential to determine the underlying reasons for divergences in trial outcomes across countries, and whether population-associated polymorphisms contribute to these differences. In the past decade, Japanese and US investigators have applied the common arm analytic method to trials in both extensive-stage small-cell lung cancer (SCLC) and advanced nonSCLC. In the SCLC analysis, a comparison of the cisplatin/irinotecan arms from both trials revealed significant differences in response rates and overall survival. Significant differences were also observed in the distribution of gender and performance status. The common arm analysis in nonSCLC included two trials from Japan and one from the USA, each containing a 'common' carboplatin/paclitaxel arm. Clinical results were similar in the two Japanese trials, but were significantly different from the US trial with regard to survival, neutropenia, febrile neutropenia and anemia. The underlying basis for these divergent outcomes is discussed. The common arm methodology provides a template for identifying and interpreting patient outcome differences across populations, and is an instructive lesson in the burgeoning era of clinical trials globalization.

Comparison of the effect of endodontic-periodontal combined lesion on the outcome of endodontic microsurgery with that of isolated endodontic lesion: survival analysis using propensity score analysis.

PubMed

Song, Minju; Kang, Minji; Kang, Dae Ryong; Jung, Hoi In; Kim, Euiseong

2018-05-01

The purpose of this retrospective clinical study was to evaluate the effect of lesion types related to endodontic microsurgery on the clinical outcome. Patients who underwent endodontic microsurgery between March 2001 and March 2014 with a postoperative follow-up period of at least 1 year were included in the study. Survival analyses were conducted to compare the clinical outcomes between isolated endodontic lesion group (endo group) and endodontic-periodontal combined lesion group (endo-perio group) and to evaluate other clinical variables. To reduce the effect of selection bias in this study, the estimated propensity scores were used to match the cases of the endo group with those of the endo-perio group. Among the 414 eligible cases, the 83 cases in the endo-perio group were matched to 166 out of the 331 cases in the endo group based on propensity score matching (PSM). The cumulated success rates of the endo and endo-perio groups were 87.3 and 72.3%, respectively. The median success period of the endo-perio group was 12 years (95% CI: 5.507, 18.498). Lesion type was found to be significant according to both Log-rank test (P = 0.002) and Cox proportional hazard regression analysis (P = 0.001). Among the other clinical variables, sex (female or male), age, and tooth type (anterior, premolar, or molar) were determined to be significant in Cox regression analysis (P < 0.05). Endodontic-periodontal combined lesions had a negative effect on the clinical outcome based on an analysis that utilized PSM, a useful statistical matching method for observational studies. Lesion type is a significant predictor of the outcome of endodontic microsurgery.

Intrinsic platelet reactivity before start with clopidogrel as predictor for on-clopidogrel platelet function and long-term clinical outcome.

PubMed

Hochholzer, Willibald; Valina, Christian M; Bömicke, Timo; Amann, Michael; Stratz, Christian; Nührenberg, Thomas; Trenk, Dietmar; Neumann, Franz-Josef

2015-07-01

High on-clopidogrel platelet reactivity is associated with worse clinical outcome. Previous data suggest that intrinsic platelet reactivity before initiation of clopidogrel contributes significantly to on-clopidogrel platelet reactivity. It is unknown whether intrinsic reactivity can sufficiently predict on-clopidogrel reactivity and therefore identify patients with insufficient response to clopidogrel before initiation of treatment and at risk for worse clinical outcome. This analysis included 765 consecutive patients undergoing elective coronary stent implantation. Platelet reactivity was assessed by light transmission aggregometry (5 µM ADP) before administration of clopidogrel 600mg and after intake of first maintenance dose of clopidogrel on day 1 following coronary stenting. Patients were followed for up to seven years. The combined primary endpoint was death of any cause or non-fatal myocardial infarction. Intrinsic and on-clopidogrel platelet reactivity were significant correlated (r=0.31; p < 0.001). Among all tested clinical and genetic factors including the cytochrome P450 2C19*2 polymorphism, intrinsic platelet reactivity was the strongest predictor for on-clopidogrel platelet reactivity. However, intrinsic platelet reactivity could only explain 8 % of variability of on-clopidogrel platelet function. Only on-treatment platelet reactivity was predictive for long-term clinical outcome (HR 1.47, 95 % CI 1.05-2.05; p = 0.02) whereas intrinsic platelet reactivity was not (HR 1.03, 95 % CI 0.74-1.43; p = 0.86). In conclusion, intrinsic platelet reactivity before initiation of clopidogrel is the strongest predictor of early on-clopidogrel platelet reactivity but can only explain a minor proportion of its variability and is not significantly associated with clinical outcome. Thus, baseline testing cannot substitute on-clopidogrel platelet function testing.

Scrub typhus in South India: clinical and laboratory manifestations, genetic variability, and outcome.

PubMed

Varghese, George M; Janardhanan, Jeshina; Trowbridge, Paul; Peter, John V; Prakash, John A J; Sathyendra, Sowmya; Thomas, Kurien; David, Thambu S; Kavitha, M L; Abraham, Ooriapadickal C; Mathai, Dilip

2013-11-01

This study sought to document the clinical and laboratory manifestations, genetic variability, and outcomes of scrub typhus, an often severe infection caused by Orientia tsutsugamushi, in South India. Patients admitted to a large teaching hospital with IgM ELISA-confirmed scrub typhus were evaluated. Clinical examination with a thorough search for an eschar, laboratory testing, chest X-ray, and outcome were documented and analyzed. Additionally, a 410-bp region of the 56-kDa type-specific antigen gene of O. tsutsugamushi was sequenced and compared with isolates from other regions of Asia. Most of the 154 patients evaluated presented with fever and non-specific symptoms. An eschar was found in 86 (55%) patients. Mild hepatic involvement was seen in most, with other organ involvement including respiratory, cardiovascular, and renal. Multi-organ dysfunction was noted in 59 (38.3%), and the fatality rate was 7.8%. Hypotension requiring vasoactive agents was found to be an independent predictor of mortality (p<0.001). The phylogeny of 26 samples showed 17 (65%) clustering with the Kato-like group and eight (31%) with the Karp-like group. The presentation of scrub typhus can be variable, often non-specific, but with potentially severe multi-organ dysfunction. Prompt recognition is key to specific treatment and good outcomes. Further study of the circulating strains is essential for the development of a successful vaccine and sensitive point-of-care testing. Copyright © 2013 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Predictors of clinical outcome following lumbar disc surgery: the value of historical, physical examination, and muscle function variables.

PubMed

Hebert, Jeffrey J; Fritz, Julie M; Koppenhaver, Shane L; Thackeray, Anne; Kjaer, Per

2016-01-01

Explore the relationships between preoperative findings and clinical outcome following lumbar disc surgery, and investigate the prognostic value of physical examination findings after accounting for information acquired from the clinical history. We recruited 55 adult patients scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability, and leg and low back pain (LBP) intensity at 10 weeks. Linear regression models were used to identify univariate and multivariate predictors of outcome. Univariate predictors of better outcome varied depending on the outcome measure. Clinical history predictors included a greater proportion of leg pain to LBP, pain medication use, greater time to surgery, and no history of previous physical or injection therapy. Physical examination predictors were a positive straight or cross straight leg raise test, diminished lower extremity strength, sensation or reflexes, and the presence of postural abnormality or pain peripheralization. Preoperative pain peripheralization remained a significant predictor of improved disability (p = 0.04) and LBP (p = 0.02) after accounting for information from the clinical history. Preoperative lumbar multifidus function was not associated with clinical outcome. Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical implementation.

CLINICAL outcomes and loss to follow-up among people living with HIV participating in the NAMWEZA intervention in Dar es Salaam, Tanzania: a prospective cohort study.

PubMed

Siril, Hellen N; Kaaya, Sylvia F; Smith Fawzi, Mary Kay; Mtisi, Expeditho; Somba, Magreat; Kilewo, Japheth; Mugusi, Ferdinand; Minja, Anna; Kaale, Anna; Todd, Jim

2017-03-28

Psychosocial factors have been linked with loss to follow-up (LTFU) and clinical outcomes among people living with HIV (PLH), however little is known about the effect of psychosocial support on LTFU among PLH in treatment and care. The purpose of this study was to explore the effect of NAMWEZA ("Yes, together we can") friends' psychosocial support intervention on clinical outcomes and LTFU among PLH. NAMWEZA is based on a novel program using "appreciative inquiry", positive psychology approaches to empower, promote positive attitudes and foster hope. PLH participating in the NAMWEZA intervention in HIV care clinics in Dar es Salaam Tanzania were compared with non-exposed PLH obtained from facilities that routinely collect clinical information and both followed longitudinally for 24 months. Baseline sociodemographic, clinical measures (CD4 cell count, hemoglobin (HGB), weight), and LTFU measures were collected. Chi square, Fisher's exact tests, and t-tests were used to compare the frequencies for categorical variables and the means of continuous variables from the intervention and the comparison groups to identify variables that were significantly different across the two groups. Random effects models were performed to examine the bivariate associations between the intervention status and clinical outcomes. At the end of 24 months of follow-up mean CD4 count and HGB levels increased significantly in both intervention and comparison groups (p = 0.009 and p < 0.0001, respectively). Weight increased significantly only in the intervention group (p = 0.003). Cumulative LTFU was three times higher in the comparison compared to the intervention (p < 0.001) group. Having a low CD4 count, extremes of weight, low HGB, younger age, and male gender were significantly associated with LTFU among the unexposed group, while being on ART for duration of 12 months or more was protective against LTFU in those intervened. Among PLH on ART, exposed or not exposed to NAMWEZA intervention, clinical care outcomes improved over time. LTFU was much higher in the comparison group with factors commonly known to predict LTFU only apparent in the comparison group. NAMWEZA could be a promising peer-facilitated model to reduce LTFU among PLH in care that can be integrated in ART services; however, more research is needed to evaluate its longer term effects.

Cognitive Ability Is Associated with Different Outcome Trajectories in Autism Spectrum Disorders

ERIC Educational Resources Information Center

Ben-Itzchak, Esther; Watson, Linda R.; Zachor, Ditza A.

2014-01-01

Variability in clinical expression and in intervention outcome has been described in autism spectrum disorder (ASD). The study examined progress after 1 and 2 years of intervention and compared the impact of baseline cognitive ability on outcome trajectories in 46 children (m = 25.5 months) with ASD. The entire group showed a gradual decrease in…

Application of autogenic training for anxiety disorders: a clinical study in a psychiatric setting.

PubMed

Sakai, M

1997-03-01

The effects of autogenic training for anxiety disorders were investigated in a psychiatric setting of a medical school hospital and the predictors of this treatment outcome were identified. Fifty-five patients who meet the DSM-III-R criteria for anxiety disorders were treated individually with autogenic training by the author from October 1981 to October 1995. The medical records of the patients were investigated retrospectively. The results showed that the autogenic training was successful. Twenty-eight patients (51%) were cured, fourteen (25%) much improved, eight (15%) improved and five (9%) unchanged at the end of the treatment. Forty-two patients (76%) were assessed as having had successful treatment. Pretreatment variables, such as patient's clinical characteristics, did not provide a useful guide to the outcome. Four treatment variables did have a bearing on outcome. First, practicing the second standard autogenic training exercise was a satisfactory predictor of a better outcome. Second, practicing generalization training also was a useful predictor. Third, the application of other behavioral treatment techniques was found to be positively associated with outcome. Fourth, longer treatment periods were associated with a better outcome. These findings suggested that autogenic training could be of significant benefit for the treatment of anxiety disorders.

Improving clinical outcomes for naltrexone as a management of problem alcohol use

PubMed Central

Hulse, Gary K

2013-01-01

Despite being a relatively effective and safe treatment, the clinical management of alcohol abuse/dependence by oral naltrexone can be compromised due to the patient's non-compliance with daily use of this medication. Over the past decade an increasing body of research has suggested that the use of sustained release depot naltrexone preparations can overcome this issue and deliver improved clinical outcomes. However, at the same time, research findings from diverse areas of pharmacogenetics, neurobiology and behavioural psychology have also been converging to identify variables including genetic markers, patient psychosocial characteristics and drug use history differences, or clusters of these variables that play a major role in mediating the response of alcohol abuse/dependent persons to treatment by naltrexone. While this article does not attempt to review all available data pertaining to an individual alcohol dependent patient's response to treatment by naltrexone, it does identify relevant research areas and highlights the importance of data arising from them. The characterization of clinical markers, to identify those patients who are most likely to benefit from naltrexone and to tailor a more individual naltrexone treatment, will ultimately provide significant benefit to both patients and clinicians by optimizing treatment outcome. PMID:22946873

Predictive value of EEG in postanoxic encephalopathy: A quantitative model-based approach.

PubMed

Efthymiou, Evdokia; Renzel, Roland; Baumann, Christian R; Poryazova, Rositsa; Imbach, Lukas L

2017-10-01

The majority of comatose patients after cardiac arrest do not regain consciousness due to severe postanoxic encephalopathy. Early and accurate outcome prediction is therefore essential in determining further therapeutic interventions. The electroencephalogram is a standardized and commonly available tool used to estimate prognosis in postanoxic patients. The identification of pathological EEG patterns with poor prognosis relies however primarily on visual EEG scoring by experts. We introduced a model-based approach of EEG analysis (state space model) that allows for an objective and quantitative description of spectral EEG variability. We retrospectively analyzed standard EEG recordings in 83 comatose patients after cardiac arrest between 2005 and 2013 in the intensive care unit of the University Hospital Zürich. Neurological outcome was assessed one month after cardiac arrest using the Cerebral Performance Category. For a dynamic and quantitative EEG analysis, we implemented a model-based approach (state space analysis) to quantify EEG background variability independent from visual scoring of EEG epochs. Spectral variability was compared between groups and correlated with clinical outcome parameters and visual EEG patterns. Quantitative assessment of spectral EEG variability (state space velocity) revealed significant differences between patients with poor and good outcome after cardiac arrest: Lower mean velocity in temporal electrodes (T4 and T5) was significantly associated with poor prognostic outcome (p<0.005) and correlated with independently identified visual EEG patterns such as generalized periodic discharges (p<0.02). Receiver operating characteristic (ROC) analysis confirmed the predictive value of lower state space velocity for poor clinical outcome after cardiac arrest (AUC 80.8, 70% sensitivity, 15% false positive rate). Model-based quantitative EEG analysis (state space analysis) provides a novel, complementary marker for prognosis in postanoxic encephalopathy. Copyright © 2017 Elsevier B.V. All rights reserved.

Statistical grand rounds: understanding the mechanism: mediation analysis in randomized and nonrandomized studies.

PubMed

Mascha, Edward J; Dalton, Jarrod E; Kurz, Andrea; Saager, Leif

2013-10-01

In comparative clinical studies, a common goal is to assess whether an exposure, or intervention, affects the outcome of interest. However, just as important is to understand the mechanism(s) for how the intervention affects outcome. For example, if preoperative anemia was shown to increase the risk of postoperative complications by 15%, it would be important to quantify how much of that effect was due to patients receiving intraoperative transfusions. Mediation analysis attempts to quantify how much, if any, of the effect of an intervention on outcome goes though prespecified mediator, or "mechanism" variable(s), that is, variables sitting on the causal pathway between exposure and outcome. Effects of an exposure on outcome can thus be divided into direct and indirect, or mediated, effects. Mediation is claimed when 2 conditions are true: the exposure affects the mediator and the mediator (adjusting for the exposure) affects the outcome. Understanding how an intervention affects outcome can validate or invalidate one's original hypothesis and also facilitate further research to modify the responsible factors, and thus improve patient outcome. We discuss the proper design and analysis of studies investigating mediation, including the importance of distinguishing mediator variables from confounding variables, the challenge of identifying potential mediators when the exposure is chronic versus acute, and the requirements for claiming mediation. Simple designs are considered, as well as those containing multiple mediators, multiple outcomes, and mixed data types. Methods are illustrated with data collected by the National Surgical Quality Improvement Project (NSQIP) and utilized in a companion paper which assessed the effects of preoperative anemic status on postoperative outcomes.

Chromosome 17 alterations identify good-risk and poor-risk tumors independently of clinical factors in medulloblastoma

PubMed Central

McCabe, Martin G.; Bäcklund, L. Magnus; Leong, Hui Sun; Ichimura, Koichi; Collins, V. Peter

2011-01-01

Current risk stratification schemas for medulloblastoma, based on combinations of clinical variables and histotype, fail to accurately identify particularly good- and poor-risk tumors. Attempts have been made to improve discriminatory power by combining clinical variables with cytogenetic data. We report here a pooled analysis of all previous reports of chromosomal copy number related to survival data in medulloblastoma. We collated data from previous reports that explicitly quoted survival data and chromosomal copy number in medulloblastoma. We analyzed the relative prognostic significance of currently used clinical risk stratifiers and the chromosomal aberrations previously reported to correlate with survival. In the pooled dataset metastatic disease, incomplete tumor resection and severe anaplasia were associated with poor outcome, while young age at presentation was not prognostically significant. Of the chromosomal variables studied, isolated 17p loss and gain of 1q correlated with poor survival. Gain of 17q without associated loss of 17p showed a trend to improved outcome. The most commonly reported alteration, isodicentric chromosome 17, was not prognostically significant. Sequential multivariate models identified isolated 17p loss, isolated 17q gain, and 1q gain as independent prognostic factors. In a historical dataset, we have identified isolated 17p loss as a marker of poor outcome and 17q gain as a novel putative marker of good prognosis. Biological markers of poor-risk and good-risk tumors will be critical in stratifying treatment in future trials. Our findings should be prospectively validated independently in future clinical studies. PMID:21292688

Clinical prediction model to identify vulnerable patients in ambulatory surgery: towards optimal medical decision-making.

PubMed

Mijderwijk, Herjan; Stolker, Robert Jan; Duivenvoorden, Hugo J; Klimek, Markus; Steyerberg, Ewout W

2016-09-01

Ambulatory surgery patients are at risk of adverse psychological outcomes such as anxiety, aggression, fatigue, and depression. We developed and validated a clinical prediction model to identify patients who were vulnerable to these psychological outcome parameters. We prospectively assessed 383 mixed ambulatory surgery patients for psychological vulnerability, defined as the presence of anxiety (state/trait), aggression (state/trait), fatigue, and depression seven days after surgery. Three psychological vulnerability categories were considered-i.e., none, one, or multiple poor scores, defined as a score exceeding one standard deviation above the mean for each single outcome according to normative data. The following determinants were assessed preoperatively: sociodemographic (age, sex, level of education, employment status, marital status, having children, religion, nationality), medical (heart rate and body mass index), and psychological variables (self-esteem and self-efficacy), in addition to anxiety, aggression, fatigue, and depression. A prediction model was constructed using ordinal polytomous logistic regression analysis, and bootstrapping was applied for internal validation. The ordinal c-index (ORC) quantified the discriminative ability of the model, in addition to measures for overall model performance (Nagelkerke's R (2) ). In this population, 137 (36%) patients were identified as being psychologically vulnerable after surgery for at least one of the psychological outcomes. The most parsimonious and optimal prediction model combined sociodemographic variables (level of education, having children, and nationality) with psychological variables (trait anxiety, state/trait aggression, fatigue, and depression). Model performance was promising: R (2)  = 30% and ORC = 0.76 after correction for optimism. This study identified a substantial group of vulnerable patients in ambulatory surgery. The proposed clinical prediction model could allow healthcare professionals the opportunity to identify vulnerable patients in ambulatory surgery, although additional modification and validation are needed. (ClinicalTrials.gov number, NCT01441843).

Predictors of physical and mental health-related quality of life outcomes among myocardial infarction patients

PubMed Central

2013-01-01

Background Health-related quality of life (HRQoL) is an important outcome for patients diagnosed with coronary heart disease. This report describes predictors of physical and mental HRQoL at six months post-hospitalisation for myocardial infarction. Methods Participants were myocardial infarction patients (n=430) admitted to two tertiary referral centres in Brisbane, Australia who completed a six month coronary heart disease secondary prevention trial (ProActive Heart). Outcome variables were HRQoL (Short Form-36) at six months, including a physical and mental summary score. Baseline predictors included demographics and clinical variables, health behaviours, and psychosocial variables. Stepwise forward multiple linear regression analyses were used to identify significant independent predictors of six month HRQoL. Results Physical HRQoL was lower in participants who: were older (p<0.001); were unemployed (p=0.03); had lower baseline physical and mental HRQoL scores (p<0.001); had lower confidence levels in meeting sufficient physical activity recommendations (p<0.001); had no intention to be physically active in the next six months (p<0.001); and were more sedentary (p=0.001). Mental HRQoL was lower in participants who: were younger (p=0.01); had lower baseline mental HRQoL (p<0.001); were more sedentary (p=0.01) were depressed (p<0.001); and had lower social support (p=0.001). Conclusions This study has clinical implications as identification of indicators of lower physical and mental HRQoL outcomes for myocardial infarction patients allows for targeted counselling or coronary heart disease secondary prevention efforts. Trial registration Australian Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, CTRN12607000595415. PMID:24020831

Onset of acute and transient psychotic disorder in India: a study of socio-demographics and factors affecting its outcomes.

PubMed

Mehta, S; Tyagi, A; Swami, M K; Gupta, S; Kumar, M; Tripathi, R

2014-06-01

Acute and transient psychotic disorder has been accepted as a distinct diagnostic entity in the ICD-10. However, there are few studies delineating its demographics and factors affecting its outcome. This study aimed to examine the socio-demographic profile of patients with acute and transient psychotic disorder and the variables associated with the onset of illness and their effect on illness outcome in an Indian setting. This was a retrospective study in which case notes of patients admitted from 1 January to 31 December 2012 and diagnosed with acute and transient psychotic disorder (according to the ICD-10 diagnostic criteria) were analysed. Socio-demographic variables and variables associated with the onset of illness were noted. Duration of hospital stay was used as a proxy measure for clinical outcome. A total of 185 patient records were analysed. Overall, 49% of the patients were males and 51% were females. Most of the cases (60%) were aged between 20 and 39 years. The majority was married, unemployed, educated up to middle school, living in a nuclear family, and had a rural background. Age (p = 0.05) and marital status (p = 0.03) significantly affected the outcome. Overall, 46% of the patients had stress as a precipitating factor, 27% reported substance use, and 23% had a family history of psychiatric illness prior to the onset of their illness. The onset of illness was from May to October in 54% of the patients, with the duration of untreated illness ranging from 7 to 15 days in 38% of the patients. The clinical outcome was significantly affected by duration of untreated illness (p = 0.05). Acute and transient psychotic disorders show slight female preponderance and occur in early adulthood. There is no precipitating stress in most cases and shorter duration of untreated illness predicts favourable clinical outcome.

Conceptual framework for outcomes research studies of hepatitis C: an analytical review

PubMed Central

Sbarigia, Urbano; Denee, Tom R; Turner, Norris G; Wan, George J; Morrison, Alan; Kaufman, Anna S; Rice, Gary; Dusheiko, Geoffrey M

2016-01-01

Hepatitis C virus infection is one of the main causes of chronic liver disease worldwide. Until recently, the standard antiviral regimen for hepatitis C was a combination of an interferon derivative and ribavirin, but a plethora of new antiviral drugs is becoming available. While these new drugs have shown great efficacy in clinical trials, observational studies are needed to determine their effectiveness in clinical practice. Previous observational studies have shown that multiple factors, besides the drug regimen, affect patient outcomes in clinical practice. Here, we provide an analytical review of published outcomes studies of the management of hepatitis C virus infection. A conceptual framework defines the relationships between four categories of variables: health care system structure, patient characteristics, process-of-care, and patient outcomes. This framework can provide a starting point for outcomes studies addressing the use and effectiveness of new antiviral drug treatments. PMID:27313473

[Patients' perspective and economic variables as objectives in clinical trials: added value to clinical parameters].

PubMed

Bovaira-García, M J; Soler-Company, E

2012-01-01

Patient-reported outcome (PRO) measures complement traditional biomedical outcome measures. The purpose of this study was to evaluate the use of PRO measures including health-related quality of life (HRQoL) questionnaires as a measurement of efficacy and the frequency of inclusion of economic variables related to direct and indirect costs in the design of clinical trials and phase IV observational studies. Moreover, for the trials quality score were measured, and if there were any relationship between the quality study design score and the PRO inclusion. Retrospective observational study of the clinical trials and phase IV observational studies approved by a Clinical Research Ethics Committee (2008-2010). We gathered data concerning general aspects including medical specialty, pathology, methodological quality based on Jadad scale (0-5), inclusion of PRO and economic variables. For clinical trials including HRQoL measurements, we analysed the type of questionnaire in use. Where there were no HRQoL measurements, we analysed if their inclusion would have been proper or not. A total of 70 protocols (59 CTs and 11 phase IV observational studies) were analysed; 37 (52.8%) included PRO measures, and 3 protocols (4.3%) used them as a primary endpoint. Data analysis by therapeutic area showed that PRO measures were most commonly studied in the fields of endocrinology, neurology, digestive diseases, and cardiology. The average quality score for the trials was 2.8. The trials with more PRO inclusion in their end points had a significantly higher quality score. Only 13 (22%) clinical trials and 2 (18.2%) phase IV observational studies included economic variables. The emergence of economic variables in clinical trials and phase IV observational studies evaluated was low, however, more than half of the revised protocols have included PRO measures, reflecting the importance of these parameters in the assessment of the effectiveness of drug treatments, although its use is still not systematic. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

The EXCITE Trial: Predicting a Clinically Meaningful Motor Activity Log Outcome

PubMed Central

Park, Si-Woon; Wolf, Steven L.; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S.

2013-01-01

Background and Objective This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. Methods A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Results Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Conclusions Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT. PMID:18780883

The EXCITE Trial: Predicting a clinically meaningful motor activity log outcome.

PubMed

Park, Si-Woon; Wolf, Steven L; Blanton, Sarah; Winstein, Carolee; Nichols-Larsen, Deborah S

2008-01-01

This study determined which baseline clinical measurements best predicted a predefined clinically meaningful outcome on the Motor Activity Log (MAL) and developed a predictive multivariate model to determine outcome after 2 weeks of constraint-induced movement therapy (CIMT) and 12 months later using the database from participants in the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial. A clinically meaningful CIMT outcome was defined as achieving higher than 3 on the MAL Quality of Movement (QOM) scale. Predictive variables included baseline MAL, Wolf Motor Function Test (WMFT), the sensory and motor portion of the Fugl-Meyer Assessment (FMA), spasticity, visual perception, age, gender, type of stroke, concordance, and time after stroke. Significant predictors identified by univariate analysis were used to develop the multivariate model. Predictive equations were generated and odds ratios for predictors were calculated from the multivariate model. Pretreatment motor function measured by MAL QOM, WMFT, and FMA were significantly associated with outcome immediately after CIMT. Pretreatment MAL QOM, WMFT, proprioception, and age were significantly associated with outcome after 12 months. Each unit of higher pretreatment MAL QOM score and each unit of faster pretreatment WMFT log mean time improved the probability of achieving a clinically meaningful outcome by 7 and 3 times at posttreatment, and 5 and 2 times after 12 months, respectively. Patients with impaired proprioception had a 20% probability of achieving a clinically meaningful outcome compared with those with intact proprioception. Baseline clinical measures of motor and sensory function can be used to predict a clinically meaningful outcome after CIMT.

Mediation analysis in nursing research: a methodological review

PubMed Central

Liu, Jianghong; Ulrich, Connie

2017-01-01

Mediation statistical models help clarify the relationship between independent predictor variables and dependent outcomes of interest by assessing the impact of third variables. This type of statistical analysis is applicable for many clinical nursing research questions, yet its use within nursing remains low. Indeed, mediational analyses may help nurse researchers develop more effective and accurate prevention and treatment programs as well as help bridge the gap between scientific knowledge and clinical practice. In addition, this statistical approach allows nurse researchers to ask – and answer – more meaningful and nuanced questions that extend beyond merely determining whether an outcome occurs. Therefore, the goal of this paper is to provide a brief tutorial on the use of mediational analyses in clinical nursing research by briefly introducing the technique and, through selected empirical examples from the nursing literature, demonstrating its applicability in advancing nursing science. PMID:26176804

CLINICALLY SIGNIFICANT PSYCHOTROPIC DRUG-DRUG INTERACTIONS IN THE PRIMARY CARE SETTING

PubMed Central

English, Brett A.; Dortch, Marcus; Ereshefsky, Larry; Jhee, Stanford

2014-01-01

In recent years, the growing numbers of patients seeking care for a wide range of psychiatric illnesses in the primary care setting has resulted in an increase in the number of psychotropic medications prescribed. Along with the increased utilization of psychotropic medications, considerable variability is noted in the prescribing patterns of primary care providers and psychiatrists. Because psychiatric patients also suffer from a number of additional medical comorbidities, the increased utilization of psychotropic medications presents an elevated risk of clinically significant drug interactions in these patients. While life-threatening drug interactions are rare, clinically significant drug interactions impacting drug response or appearance of serious adverse drug reactions have been documented and can impact long-term outcomes. Additionally, the impact of genetic variability on the psychotropic drug’s pharmacodynamics and/or pharmacokinetics may further complicate drug therapy. Increased awareness of clinically relevant psychotropic drug interactions can aid clinicians to achieve optimal therapeutic outcomes in patients in the primary care setting. PMID:22707017

The effect of supervised Tai Chi intervention compared to a physiotherapy program on fall-related clinical outcomes: a randomized clinical trial.

PubMed

Tousignant, Michel; Corriveau, Hélène; Roy, Pierre-Michel; Desrosiers, Johanne; Dubuc, Nicole; Hébert, Réjean; Tremblay-Boudreault, Valérie; Beaudoin, Audrée-Jeanne

2012-01-01

To assess some fall-related clinical variables (balance, gait, fear of falling, functional autonomy, self-actualization and self-efficacy) that might explain the fact that supervised Tai Chi has a better impact on preventing falls compared to a conventional physiotherapy program. The participants (152 older adults over 65 who were admitted to a geriatric day hospital program) were randomly assigned to either a supervised Tai Chi group or the usual physiotherapy. The presence of the clinical variables related to falls was evaluated before the intervention (T1), immediately after (T2), and 12 months after the end of the intervention (T3). Both exercise programs significantly improved fall-related outcomes but only the Tai Chi intervention group decreased the incidence of falls. For both groups, most variables followed the same pattern, i.e. showed significant improvement with the intervention between T1 and T2, and followed by a statistically significant decrease at the T3 evaluation. However, self-efficacy was the only variable that improved solely with the Tai Chi intervention (p = 0.001). The impact of supervised Tai Chi on fall prevention can not be explained by a differential effect on balance, gait and fear of falling. It appeared to be related to an increase of general self-efficacy, a phenomenon which is not seen in the conventional physiotherapy program.

Clinico-pathological and biological prognostic variables in squamous cell carcinoma of the vulva.

PubMed

Gadducci, Angiolo; Tana, Roberta; Barsotti, Cecilia; Guerrieri, Maria Elena; Genazzani, Andrea Riccardo

2012-07-01

Several clinical-pathological parameters have been related to survival of patients with invasive squamous cell carcinoma of the vulva, whereas few studies have investigated the ability of biological variables to predict the clinical outcome of these patients. The present paper reviews the literature data on the prognostic relevance of lymph node-related parameters, primary tumor-related parameters, FIGO stage, blood variables, and tissue biological variables. Regarding these latter, the paper takes into account the analysis of DNA content, cell cycle-regulatory proteins, apoptosis-related proteins, epidermal growth factor receptor [EGFR], and proteins that are involved in tumor invasiveness, metastasis and angiogenesis. At present, the lymph node status and FIGO stage according to the new 2009 classification system are the main predictors for vulvar squamous cell carcinoma, whereas biological variables do not have yet a clinical relevance and their role is still investigational. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Benchmarking the perioperative process: II. Introducing anesthesia clinical pathways to improve processes and outcomes and to reduce nursing labor intensity in ambulatory orthopedic surgery.

PubMed

Williams, B A; DeRiso, B M; Engel, L B; Figallo, C M; Anders, J W; Sproul, K A; Ilkin, H; Harner, C D; Fu, F H; Nagarajan, N J; Evans, J H; Watkins, W D

1998-11-01

(1) To introduce anesthesia clinical pathways as a management tool to improve the quality of care; (2) to use the Procedural Times Glossary published by the Association of Anesthesia Clinical Directors (AACD) as a template for data collection and analysis; and (3) to determine the effects of anesthesia clinical pathways on surgical processes, outcomes, and costs in common ambulatory orthopedic surgery. Hospital database and patient chart review of consecutive patients undergoing anterior cruciate ligament reconstruction (ACLR) during academic years (AY) 1995-1996 and 1996-1997. Patient data from AY 1995-1996, during which no intraoperative anesthesia clinical pathways existed, served as historical controls. Data from AY 1996-1997, during which intraoperative anesthesia clinical pathways were used, served as the treatment group. Regional anesthesia options were routinely offered to patients in the clinical pathway. Ambulatory surgery center in a teaching hospital. The records of 503 ASA physical status I and II patients were reviewed. 1996-1997 patients underwent clinical pathway anesthesia care in which the intraoperative and postoperative anesthesia process was standardized with respect to symptom management, drugs, and equipment used. 1995-1996 patients did not have a standardized intraoperative and postoperative anesthetic course with respect to the management of common symptoms or to specific drugs and supplies used. Intervals described in the AACD Procedural Times Glossary, anesthesia drug and supply costs, and patient outcome variables (postoperative nursing interventions required and unexpected admissions), as influenced by the use of the anesthesia clinical pathway, were measured. Clinical pathway anesthesia care of ACLR in 1996-1997, which actively incorporated regional anesthesia options, reduced pharmacy and materials cost variability; slightly increased turnover time; improved intraoperative anesthesia and surgical efficiency, recovery times, and unexpected admission rates; and decreased the number of required nursing interventions for common postoperative symptoms. Clinical pathway patient management systems in anesthesia care are likely to produce useful outcome data of current practice patterns when compared with historical controls. This management tool may be useful in simultaneously containing costs and improving process efficiency and patient outcomes.

Predictors of professional behaviour and academic outcomes in a UK medical school: A longitudinal cohort study.

PubMed

Adam, Jane; Bore, Miles; Childs, Roy; Dunn, Jason; Mckendree, Jean; Munro, Don; Powis, David

2015-01-01

Over the past 70 years, there has been a recurring debate in the literature and in the popular press about how best to select medical students. This implies that we are still not getting it right: either some students are unsuited to medicine or the graduating doctors are considered unsatisfactory, or both. To determine whether particular variables at the point of selection might distinguish those more likely to become satisfactory professional doctors, by following a complete intake cohort of students throughout medical school and analysing all the data used for the students' selection, their performance on a range of other potential selection tests, academic and clinical assessments throughout their studies, and records of professional behaviour covering the entire five years of the course. A longitudinal database captured the following anonymised information for every student (n = 146) admitted in 2007 to the Hull York Medical School (HYMS) in the UK: demographic data (age, sex, citizenship); performance in each component of the selection procedure; performance in some other possible selection instruments (cognitive and non-cognitive psychometric tests); professional behaviour in tutorials and in other clinical settings; academic performance, clinical and communication skills at summative assessments throughout; professional behaviour lapses monitored routinely as part of the fitness-to-practise procedures. Correlations were sought between predictor variables and criterion variables chosen to demonstrate the full range of course outcomes from failure to complete the course to graduation with honours, and to reveal clinical and professional strengths and weaknesses. Student demography was found to be an important predictor of outcomes, with females, younger students and British citizens performing better overall. The selection variable "HYMS academic score", based on prior academic performance, was a significant predictor of components of Year 4 written and Year 5 clinical examinations. Some cognitive subtest scores from the UK Clinical Aptitude Test (UKCAT) and the UKCAT total score were also significant predictors of the same components, and a unique predictor of the Year 5 written examination. A number of the non-cognitive tests were significant independent predictors of Years 4 and 5 clinical performance, and of lapses in professional behaviour. First- and second-year tutor ratings were significant predictors of all outcomes, both desirable and undesirable. Performance in Years 1 and 2 written exams did not predict performance in Year 4 but did generally predict Year 5 written and clinical performance. Measures of a range of relevant selection attributes and personal qualities can predict intermediate and end of course achievements in academic, clinical and professional behaviour domains. In this study HYMS academic score, some UKCAT subtest scores and the total UKCAT score, and some non-cognitive tests completed at the outset of studies, together predicted outcomes most comprehensively. Tutor evaluation of students early in the course also identified the more and less successful students in the three domains of academic, clinical and professional performance. These results may be helpful in informing the future development of selection tools.

Clinical Implications of Cluster Analysis-Based Classification of Acute Decompensated Heart Failure and Correlation with Bedside Hemodynamic Profiles.

PubMed

Ahmad, Tariq; Desai, Nihar; Wilson, Francis; Schulte, Phillip; Dunning, Allison; Jacoby, Daniel; Allen, Larry; Fiuzat, Mona; Rogers, Joseph; Felker, G Michael; O'Connor, Christopher; Patel, Chetan B

2016-01-01

Classification of acute decompensated heart failure (ADHF) is based on subjective criteria that crudely capture disease heterogeneity. Improved phenotyping of the syndrome may help improve therapeutic strategies. To derive cluster analysis-based groupings for patients hospitalized with ADHF, and compare their prognostic performance to hemodynamic classifications derived at the bedside. We performed a cluster analysis on baseline clinical variables and PAC measurements of 172 ADHF patients from the ESCAPE trial. Employing regression techniques, we examined associations between clusters and clinically determined hemodynamic profiles (warm/cold/wet/dry). We assessed association with clinical outcomes using Cox proportional hazards models. Likelihood ratio tests were used to compare the prognostic value of cluster data to that of hemodynamic data. We identified four advanced HF clusters: 1) male Caucasians with ischemic cardiomyopathy, multiple comorbidities, lowest B-type natriuretic peptide (BNP) levels; 2) females with non-ischemic cardiomyopathy, few comorbidities, most favorable hemodynamics; 3) young African American males with non-ischemic cardiomyopathy, most adverse hemodynamics, advanced disease; and 4) older Caucasians with ischemic cardiomyopathy, concomitant renal insufficiency, highest BNP levels. There was no association between clusters and bedside-derived hemodynamic profiles (p = 0.70). For all adverse clinical outcomes, Cluster 4 had the highest risk, and Cluster 2, the lowest. Compared to Cluster 4, Clusters 1-3 had 45-70% lower risk of all-cause mortality. Clusters were significantly associated with clinical outcomes, whereas hemodynamic profiles were not. By clustering patients with similar objective variables, we identified four clinically relevant phenotypes of ADHF patients, with no discernable relationship to hemodynamic profiles, but distinct associations with adverse outcomes. Our analysis suggests that ADHF classification using simultaneous considerations of etiology, comorbid conditions, and biomarker levels, may be superior to bedside classifications.

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.

Child involvement, alliance, and therapist flexibility: process variables in cognitive-behavioural therapy for anxiety disorders in childhood.

PubMed

Hudson, Jennifer L; Kendall, Philip C; Chu, Brian C; Gosch, Elizabeth; Martin, Erin; Taylor, Alan; Knight, Ashleigh

2014-01-01

This study examined the relations between treatment process variables and child anxiety outcomes. Independent raters watched/listened to taped therapy sessions of 151 anxiety-disordered (6-14 yr-old; M = 10.71) children (43% boys) and assessed process variables (child alliance, therapist alliance, child involvement, therapist flexibility and therapist functionality) within a manual-based cognitive-behavioural treatment. Latent growth modelling examined three latent variables (intercept, slope, and quadratic) for each process variable. Child age, gender, family income and ethnicity were examined as potential antecedents. Outcome was analyzed using factorially derived clinician, mother, father, child and teacher scores from questionnaire and structured diagnostic interviews at pretreatment, posttreatment and 12-month follow-up. Latent growth models demonstrated a concave quadratic curve for child involvement and therapist flexibility over time. A predominantly linear, downward slope was observed for alliance, and functional flexibility remained consistent over time. Increased alliance, child involvement and therapist flexibility showed some albeit inconsistent, associations with positive treatment outcome. Findings support the notion that maintaining the initial high level of alliance or involvement is important for clinical improvement. There is some support that progressively increasing alliance/involvement also positively impacts on treatment outcome. These findings were not consistent across outcome measurement points or reporters. Copyright © 2013 Elsevier Ltd. All rights reserved.

High Variability in Outcome Reporting Patterns in High-Impact ACL Literature.

PubMed

Makhni, Eric C; Padaki, Ajay S; Petridis, Petros D; Steinhaus, Michael E; Ahmad, Christopher S; Cole, Brian J; Bach, Bernard R

2015-09-16

ACL (anterior cruciate ligament) reconstruction is one of the most commonly performed and studied procedures in modern sports medicine. A multitude of objective and subjective patient outcome measures exists; however, nonstandardized reporting patterns of these metrics may create challenges in objectively analyzing pooled results from different studies. The goal of this study was to document the variability in outcome reporting patterns in high-impact orthopaedic studies of ACL reconstruction. All clinical studies pertaining to ACL reconstruction in four high-impact-factor orthopaedic journals over a five-year period were reviewed. Biomechanical, basic science, and imaging studies were excluded, as were studies with fewer than fifty patients, yielding 119 studies for review. Incorporation of various objective and subjective outcomes was noted for each study. Substantial variability in reporting of both objective and subjective measures was noted in the study cohort. Although a majority of studies reported instrumented laxity findings, there was substantial variability in the type and method of laxity reporting. Most other objective outcomes, including range of motion, strength, and complications, were reported in <50% of all studies. Return to pre-injury level of activity was infrequently reported (24% of studies), as were patient satisfaction and pain assessment following surgery (8% and 13%, respectively). Of the patient-reported outcomes, the International Knee Documentation Committee (IKDC), Lysholm, and Tegner scores were most often reported (71%, 63%, and 42%, respectively). Substantial variability in outcome reporting patterns exists among high-impact studies of ACL reconstruction. Such variability may create challenges in interpreting results and pooling them across different studies. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Do women fare worse? A metaanalysis of gender differences in outcome after traumatic brain injury.

PubMed

Farace, E; Alves, W M

2000-01-01

The purpose of this metaanalysis was to investigate possible gender differences in TBI sequelae. The case fatality rates in patients after TBI have previously been shown to be significantly higher in women as compared with men. A quantitative review of published studies of TBI outcome revealed eight studies (20 outcome variables) of TBI in which outcome was reported separately for men and women. Outcome was worse in women than in men for 85% of the measured variables, with an average effect size of -0.15. Although clinical opinion is often that women tend to experience better outcomes than do men after TBI, the opposite pattern was suggested in the results of this metaanalysis. However, this conclusion is limited by the fact that in only a small percentage of the total published reports on TBI outcome was outcome described separately for each sex. A careful, prospective study of sex differences in TBI outcome is clearly needed.

Enhancing nurses' ethical practice: development of a clinical ethics program.

PubMed

McDaniel, C

1998-06-01

There is increasing attention paid to ethics under managed care; however, few clinical-based ethics programs are reported. This paper reports the assessment and outcomes of one such program. A quasi-experimental research design with t-tests is used to assess the outcome differences between participants and control groups. There are twenty nurses in each; they are assessed for comparability. Differences are predicted on two outcomes using reliable and valid measures: nurses' time with their patients in ethics discussions, and nurses' opinions regarding their clinical ethics environments. Results reveal a statistically significant difference (p <.05) between the two groups, with modest positive change in the participants. Additional exploratory analyses are reported on variables influential in health care services.

Disease-specific quality of life after septoplasty and bilateral inferior turbinate outfracture in patients with nasal obstruction.

PubMed

Resende, Lucas; Carmo, Carolina do; Mocellin, Leão; Pasinato, Rogério; Mocellin, Marcos

2017-07-29

Septal deviations might cause nasal obstruction and negative impact on the quality of life of individuals. The efficacy of septoplasty for treatment of septal deviation and the predictors of satisfactory surgical outcomes remain controversial. Technical variability, heterogeneity of research samples and absence of a solid tool for clinical evaluation are the main hindrances to the establishment of reliable statistical data regarding the procedure. To evaluate the clinical improvements in the disease-specific quality-of-life between patients submitted to septoplasty with bilateral outfracture of the inferior turbinate under sedation and local anesthesia in a tertiary hospital and to assess possible clinical-epidemiological variables associated with functional outcome. Fifty-two patients consecutively submitted to septoplasty with bilateral outfracture of the inferior turbinate for treatment of nasal obstruction filled in forms regarding clinical and epidemiological information during enrollment and had their symptom objectively quantified using the Nose Obstruction Symptom Evaluation (NOSE) scale preoperatively and one and three months after the procedure. Statistical analysis aimed to determine overall and stratified surgical outcomes and to investigate correlations between the clinical-epidemiological variables with the scores obtained. Statistically significant improvement in the preoperative NOSE questionnaire compared to the scores obtained three months after surgery was demonstrated (p<0.001, T-Wilcoxon), with strong correlation between the preoperative score and the postoperative improvement during this period (r=-0.614, p<0.001, Spearman). After one month, patients reached in average 87.15% of the result obtained at the study termination. Smokers and patients with rhinitis and/or pulmonary comorbidity showed increased average preoperative NOSE scores, although without statistical significance (p>0.05). Gender, age, history of rhinitis and presence of pulmonary comorbidity did not influence significantly surgical outcomes (p>0.05). Smokers presented greater reduction in NOSE scores during the study (p=0.043, U-Mann-Whitney). Septoplasty with bilateral outfracture of the inferior turbinate has proven to significantly improve disease-specific quality-of-life and this favorable outcome seems to occur precociously. Copyright © 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Does improvement of cognitive functioning by cognitive remediation therapy effect work outcomes in severe mental illness? A secondary analysis of a randomized controlled trial.

PubMed

Ikebuchi, Emi; Sato, Sayaka; Yamaguchi, Sosei; Shimodaira, Michiyo; Taneda, Ayano; Hatsuse, Norifumi; Watanabe, Yukako; Sakata, Masuhiro; Satake, Naoko; Nishio, Masaaki; Ito, Jun-Ichiro

2017-05-01

The aim of this study was to clarify whether improvement of cognitive functioning by cognitive remediation therapy can improve work outcome in schizophrenia and other severe mental illnesses when combined with supported employment. The subjects of this study were persons with severe mental illness diagnosed with schizophrenia, major depression, or bipolar disorder (ICD-10) and cognitive dysfunction who participated in both cognitive remediation using the Thinking Skills for Work program and a supported employment program in a multisite, randomized controlled study. Logistic and multiple linear regression analyses were performed to clarify the influence of cognitive functioning on vocational outcomes, adjusting for demographic and clinical variables. Improvement of cognitive functioning with cognitive remediation significantly contributed to the total days employed and total earnings of competitive employment in supported employment service during the study period. Any baseline demographic and clinical variables did not significantly contribute to the work-related outcomes. A cognitive remediation program transferring learning skills into the real world is useful to increase the quality of working life in supported employment services for persons with severe mental illness and cognitive dysfunction who want to work competitively. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

Accounting for pharmacokinetic and pharmacodynamic variability: ten factors to consider before prescribing.

PubMed

O'Malley, Patricia

2007-01-01

Outcomes of pharmacological therapy are more than an accurate assessment and appropriate choice of an agent. Patient outcomes are the result of complex interactions of factors known and unknown. This study explores 10 of many factors that clinical nurse specialists should consider before writing the prescription and monitoring responses to therapy.

The role of insurance claims databases in drug therapy outcomes research.

PubMed

Lewis, N J; Patwell, J T; Briesacher, B A

1993-11-01

The use of insurance claims databases in drug therapy outcomes research holds great promise as a cost-effective alternative to post-marketing clinical trials. Claims databases uniquely capture information about episodes of care across healthcare services and settings. They also facilitate the examination of drug therapy effects on cohorts of patients and specific patient subpopulations. However, there are limitations to the use of insurance claims databases including incomplete diagnostic and provider identification data. The characteristics of the population included in the insurance plan, the plan benefit design, and the variables of the database itself can influence the research results. Given the current concerns regarding the completeness of insurance claims databases, and the validity of their data, outcomes research usually requires original data to validate claims data or to obtain additional information. Improvements to claims databases such as standardisation of claims information reporting, addition of pertinent clinical and economic variables, and inclusion of information relative to patient severity of illness, quality of life, and satisfaction with provided care will enhance the benefit of such databases for outcomes research.

Rank-based estimation in the {ell}1-regularized partly linear model for censored outcomes with application to integrated analyses of clinical predictors and gene expression data.

PubMed

Johnson, Brent A

2009-10-01

We consider estimation and variable selection in the partial linear model for censored data. The partial linear model for censored data is a direct extension of the accelerated failure time model, the latter of which is a very important alternative model to the proportional hazards model. We extend rank-based lasso-type estimators to a model that may contain nonlinear effects. Variable selection in such partial linear model has direct application to high-dimensional survival analyses that attempt to adjust for clinical predictors. In the microarray setting, previous methods can adjust for other clinical predictors by assuming that clinical and gene expression data enter the model linearly in the same fashion. Here, we select important variables after adjusting for prognostic clinical variables but the clinical effects are assumed nonlinear. Our estimator is based on stratification and can be extended naturally to account for multiple nonlinear effects. We illustrate the utility of our method through simulation studies and application to the Wisconsin prognostic breast cancer data set.

A Two Year Longitudinal Outcome Study of Addicted Health Care Professionals: An Investigation of the Role of Personality Variables

PubMed Central

Angres, Daniel; Bologeorges, Stephanie; Chou, Jessica

2013-01-01

The co-morbidity of personality disorders (PDs) and other dysregulatory personality patterns with addiction have been well-established, although few studies have examined this interplay on long-term sobriety outcome. In addition, health care professionals suffering from addiction have both a significant public health impact and a unique set of treatment and recovery challenges. The aim of this study was to investigate if personality variables differentiated sobriety outcome in this population over a two year interval. A clinical sample of health care professionals participated in a substance abuse hospital treatment program individually tailored with respect to personality. Participants took the Temperament and Character Inventory and the Millon Clinical Multiaxial Inventory at intake, and were tracked two years post-discharge to determine sobriety status. Univariate analyses showed antisocial personality, female gender, and alcohol dependence were independent predictors of relapse, however a significant relationship between personality and substance use did not exist in multivariate analysis when controlling for demographic variables The lack of multivariate relationships demonstrates the heterogeneity in self-report measures of personality, which suggests the interplay of personality and addiction is complex and individualized. PMID:23531922

How large must a treatment effect be before it matters to practitioners? An estimation method and demonstration.

PubMed

Miller, William R; Manuel, Jennifer Knapp

2008-09-01

Treatment research is sometimes criticised as lacking in clinical relevance, and one potential source of this friction is a disconnection between statistical significance and what clinicians regard to be a meaningful difference in outcomes. This report demonstrates a novel methodology for estimating what substance abuse practitioners regard to be clinically important differences. To illustrate the estimation method, we surveyed 50 substance abuse treatment providers participating in the National Institute on Drug Abuse (NIDA) Clinical Trials Network. Practitioners identified thresholds for clinically meaningful differences on nine common outcome variables, indicated the size of effect that would justify their learning a new treatment method and estimated current outcomes from their services. Clinicians judged a difference between two treatments to be meaningful if outcomes were improved by about 10 - 12 points on the percentage of patients totally abstaining, arrested for driving while intoxicated, employed or having abnormal liver enzymes. A 5 percentage-point reduction in patient mortality was regarded as clinically significant. On continuous outcome measures (such as percentage of days abstinent or drinks per drinking day), practitioners judged an outcome to be significant when it doubled or halved the base rate. When a new treatment meets such criteria, practitioners were interested in learning it. Effects that are statistically significant in clinical trials may be unimpressive to practitioners. Clinicians' judgements of meaningful differences can inform the powering of clinical trials.

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

PubMed

Chow, Philip I; Ingersoll, Karen S; Thorndike, Frances P; Lord, Holly R; Gonder-Frederick, Linda; Morin, Charles M; Ritterband, Lee M

2018-07-01

The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]). Three hundred and three participants (M age  = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period. Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later. Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes. Published by Elsevier B.V.

Exploring the Association of Hospice Care on Patient Experience and Outcomes of Care

PubMed Central

Kleinpell, Ruth; Vasilevskis, Eduard E.; Fogg, Louis; Ely, E. Wesley

2016-01-01

Objective To examine the association of the use of hospice care on patient experience and outcomes of care. Promoting high-value, safe, and effective care is an international healthcare imperative. However, the extent to which hospice care may improve the value of care is not well characterized. Methods A secondary analysis of variations in care was conducted using the Dartmouth Atlas Report, matched to the American Hospital Association Annual Survey Database to abstract organizational characteristics for 236 US hospitals to examine the relationship between hospice utilization and a number of variables that represent care value including hospital care intensity index, hospital deaths, ICU deaths, patient satisfaction, and a number of patient quality indicators. Structural equation modeling was used to demonstrate the effect of hospice use on patient experience of care variables, clinical outcomes of care variables, and efficiency of care variables. Results Hospice admissions in the last 6 months of life were correlated with a number of variables including increases in patient satisfaction ratings (r=0.448, p=0.01) and better pain control (r=0.491, p=0.01), and reductions in hospital days (r=−0.517, p=0.01), fewer deaths in the hospital (r=−0.842, p=0.01), and fewer deaths occurring with an ICU admission during hospitalization (r=−0.358, p=0.01). The structural equation model identified use of hospice care was inversely related to both hospital mortality (−.885) and ICU mortality rate (−.457). Conclusions The results of this investigation demonstrate that greater utilization of hospice care during the last 6-months of life is associated with improved patient experience of care including satisfaction and pain control, as well as clinical outcomes of care including decreased ICU and hospital mortality. PMID:27531840

Systematic review of SMART Recovery: Outcomes, process variables, and implications for research.

PubMed

Beck, Alison K; Forbes, Erin; Baker, Amanda L; Kelly, Peter J; Deane, Frank P; Shakeshaft, Anthony; Hunt, David; Kelly, John F

2017-02-01

Clinical guidelines recommend Self-Management and Recovery Training (SMART Recovery) and 12-step models of mutual aid as important sources of long-term support for addiction recovery. Methodologically rigorous reviews of the efficacy and potential mechanisms of change are available for the predominant 12-step approach. A similarly rigorous exploration of SMART Recovery has yet to be undertaken. We aim to address this gap by providing a systematic overview of the evidence for SMART Recovery in adults with problematic alcohol, substance, and/or behavioral addiction, including (i) a commentary on outcomes assessed, process variables, feasibility, current understanding of mental health outcomes, and (ii) a critical evaluation of the methodology. We searched six electronic peer-reviewed and four gray literature databases for English-language SMART Recovery literature. Articles were classified, assessed against standardized criteria, and checked by an independent assessor. Twelve studies (including three evaluations of effectiveness) were identified. Alcohol-related outcomes were the primary focus. Standardized assessment of nonalcohol substance use was infrequent. Information about behavioral addiction was restricted to limited prevalence data. Functional outcomes were rarely reported. Feasibility was largely indexed by attendance. Economic analysis has not been undertaken. Little is known about the variables that may influence treatment outcome, but attendance represents a potential candidate. Assessment and reporting of mental health status was poor. Although positive effects were found, the modest sample and diversity of methods prevent us from making conclusive remarks about efficacy. Further research is needed to understand the clinical and public health utility of SMART as a viable recovery support option. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Correlates of low back pain outcomes in a community clinic.

PubMed

Lowdermilk, A; Panus, P C; Kalbfleisch, J H

1999-08-01

Both governmental and private agencies have focused on the multiple outcome variables that may affect patient treatment. Our investigation examined treatment-independent outcome variables and correlates in patients with the sole complaint of low back pain. Treatment was conducted in an outpatient physical therapy clinic serving a rural/suburban Tennessee population. The review collected data on nine variables from 54 clinic records. The study group was 56% female, with ages for all subjects ranging from 26 to 84 years. Twenty-five patients carried private insurance, 14 were TennCare recipients (state Medicaid), 9 were covered by workers compensation, and 6 were Medicare based. The prescribed number of treatment sessions (Rx) varied from 1 to 3 visits to as many as 18. The Rx was not related to sex, age, or payer type. The compliance index (Cx) (mean = 76.3%, range = 6% to 150%) was related to payer type (P < .02), but not related to sex, age, or Rx. TennCare patients had lower compliance levels (mean Cx = 51.1) than all other insurer groups combined (mean Cx = 85.0). Self-assessed improvement by the patient (Patient Status) was related to Cx (P < 0.005) but not sex, age, payer type, or Rx. Completion by the patient of long-term physical therapy goals as determined by the therapist was related to Cx (P < .03) and self-assessed patient status (P < .02), while disposition at discharge was associated with Cx, self-assessed patient status, and payer type (P < .001). Compliance by patients significantly influences the outcome measures of self-assessed improvement, therapist assessment of achieving long-term treatment goals, and disposition at discharge. TennCare patients demonstrated both low compliance and poor outcome at discharge. These results suggest that the lower potential for positive treatment outcome may exist for the TennCare patient population.

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

ERIC Educational Resources Information Center

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Predictors of clinical outcome in emphysema patients with atelectasis following endoscopic valve therapy: A retrospective study.

PubMed

Gompelmann, Daniela; Hofbauer, Tobias; Gerovasili, Vasiliki; Eberhardt, Ralf; Lim, Hyun-Ju; Herth, Felix; Heussel, Claus-Peter

2016-10-01

The aim of endoscopic valve therapy in patients with emphysema is complete lobar atelectasis of the most emphysematous lobe. However, even after the radiological advent of atelectasis, great variability in clinical outcomes can be observed. The baseline clinical measures (vital capacity (VC), forced expiratory flow in 1 s (FEV1 ), residual volume (RV) and 6-min walk test (6-MWT)) and computed tomography variables (low attenuation volume (LAV) of the target lobe, LAV% of the target and the ipsilateral untreated lobe and LAV of the target lobe to LAV of the target lung and to LAV of the total lung) of 77 patients with complete atelectasis following valve therapy were retrospectively examined to determine their impact on patient´s outcome (changes in VC, FEV1 , RV and 6-MWT from baseline to the time of atelectasis). Low attenuation volume of the target lobe to LAV of the target lung predicts a significant FEV1 improvement in patients with complete lobar atelectasis following valve therapy. A 10% difference in that computed tomography predictor was associated with a 82-mL improvement in FEV1 (P = 0.006). Lower 6-MWT scores, low VC and high RV at baseline were significantly associated with greater improvement in the respective parameter (all P < 0.001). Low attenuation volume of the target lobe to LAV of the target lung and baseline clinical measures seem to significantly predict clinical outcomes in patients with complete lobar atelectasis following valve treatment. © 2016 Asian Pacific Society of Respirology.

Low Cerebral Blood Volume Identifies Poor Outcome in Stent Retriever Thrombectomy

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

Protto, Sara, E-mail: sara.protto@pshp.fi; Pienimäki, Juha-Pekka; Seppänen, Janne

BackgroundMechanical thrombectomy (MT) is an efficient treatment of acute stroke caused by large-vessel occlusion. We evaluated the factors predicting poor clinical outcome (3-month modified Rankin Scale, mRS >2) although MT performed with modern stent retrievers.MethodsWe prospectively collected the clinical and imaging data of 105 consecutive anterior circulation stroke patients who underwent MT after multimodal CT imaging. Patients with occlusion of the internal carotid artery and/or middle cerebral artery up to the M2 segment were included. We recorded baseline clinical, procedural and imaging variables, technical outcome, 24-h imaging outcome and the clinical outcome. Differences between the groups were studied with appropriatemore » statistical tests and binary logistic regression analysis.ResultsLow cerebral blood volume Alberta stroke program early CT score (CBV-ASPECTS) was associated with poor clinical outcome (median 7 vs. 9, p = 0.01). Lower collateral score (CS) significantly predicted poor outcome in regression modelling with CS = 0 increasing the odds of poor outcome 4.4-fold compared to CS = 3 (95% CI 1.27–15.5, p = 0.02). Lower CBV-ASPECTS significantly predicted poor clinical outcome among those with moderate or severe stroke (OR 0.82, 95% CI 0.68–1, p = 0.05) or poor collateral circulation (CS 0–1, OR 0.66, 95% CI 0.48–0.90, p = 0.009) but not among those with mild strokes or good collaterals.ConclusionsCBV-ASPECTS estimating infarct core is a significant predictor of poor clinical outcome among anterior circulation stroke patients treated with MT, especially in the setting of poor collateral circulation and/or moderate or severe stroke.« less

The intermediate endpoint effect in logistic and probit regression

PubMed Central

MacKinnon, DP; Lockwood, CM; Brown, CH; Wang, W; Hoffman, JM

2010-01-01

Background An intermediate endpoint is hypothesized to be in the middle of the causal sequence relating an independent variable to a dependent variable. The intermediate variable is also called a surrogate or mediating variable and the corresponding effect is called the mediated, surrogate endpoint, or intermediate endpoint effect. Clinical studies are often designed to change an intermediate or surrogate endpoint and through this intermediate change influence the ultimate endpoint. In many intermediate endpoint clinical studies the dependent variable is binary, and logistic or probit regression is used. Purpose The purpose of this study is to describe a limitation of a widely used approach to assessing intermediate endpoint effects and to propose an alternative method, based on products of coefficients, that yields more accurate results. Methods The intermediate endpoint model for a binary outcome is described for a true binary outcome and for a dichotomization of a latent continuous outcome. Plots of true values and a simulation study are used to evaluate the different methods. Results Distorted estimates of the intermediate endpoint effect and incorrect conclusions can result from the application of widely used methods to assess the intermediate endpoint effect. The same problem occurs for the proportion of an effect explained by an intermediate endpoint, which has been suggested as a useful measure for identifying intermediate endpoints. A solution to this problem is given based on the relationship between latent variable modeling and logistic or probit regression. Limitations More complicated intermediate variable models are not addressed in the study, although the methods described in the article can be extended to these more complicated models. Conclusions Researchers are encouraged to use an intermediate endpoint method based on the product of regression coefficients. A common method based on difference in coefficient methods can lead to distorted conclusions regarding the intermediate effect. PMID:17942466

Generated effect modifiers (GEM’s) in randomized clinical trials

PubMed Central

Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R. Todd

2017-01-01

In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an “effect modifier”. Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. PMID:27465235

Clinical and Biological Relevance of Genomic Heterogeneity in Chronic Lymphocytic Leukemia

PubMed Central

Friedman, Daphne R.; Lucas, Joseph E.; Weinberg, J. Brice

2013-01-01

Background Chronic lymphocytic leukemia (CLL) is typically regarded as an indolent B-cell malignancy. However, there is wide variability with regards to need for therapy, time to progressive disease, and treatment response. This clinical variability is due, in part, to biological heterogeneity between individual patients’ leukemias. While much has been learned about this biological variation using genomic approaches, it is unclear whether such efforts have sufficiently evaluated biological and clinical heterogeneity in CLL. Methods To study the extent of genomic variability in CLL and the biological and clinical attributes of genomic classification in CLL, we evaluated 893 unique CLL samples from fifteen publicly available gene expression profiling datasets. We used unsupervised approaches to divide the data into subgroups, evaluated the biological pathways and genetic aberrations that were associated with the subgroups, and compared prognostic and clinical outcome data between the subgroups. Results Using an unsupervised approach, we determined that approximately 600 CLL samples are needed to define the spectrum of diversity in CLL genomic expression. We identified seven genomically-defined CLL subgroups that have distinct biological properties, are associated with specific chromosomal deletions and amplifications, and have marked differences in molecular prognostic markers and clinical outcomes. Conclusions Our results indicate that investigations focusing on small numbers of patient samples likely provide a biased outlook on CLL biology. These findings may have important implications in identifying patients who should be treated with specific targeted therapies, which could have efficacy against CLL cells that rely on specific biological pathways. PMID:23468975

Clinical and biological relevance of genomic heterogeneity in chronic lymphocytic leukemia.

PubMed

Friedman, Daphne R; Lucas, Joseph E; Weinberg, J Brice

2013-01-01

Chronic lymphocytic leukemia (CLL) is typically regarded as an indolent B-cell malignancy. However, there is wide variability with regards to need for therapy, time to progressive disease, and treatment response. This clinical variability is due, in part, to biological heterogeneity between individual patients' leukemias. While much has been learned about this biological variation using genomic approaches, it is unclear whether such efforts have sufficiently evaluated biological and clinical heterogeneity in CLL. To study the extent of genomic variability in CLL and the biological and clinical attributes of genomic classification in CLL, we evaluated 893 unique CLL samples from fifteen publicly available gene expression profiling datasets. We used unsupervised approaches to divide the data into subgroups, evaluated the biological pathways and genetic aberrations that were associated with the subgroups, and compared prognostic and clinical outcome data between the subgroups. Using an unsupervised approach, we determined that approximately 600 CLL samples are needed to define the spectrum of diversity in CLL genomic expression. We identified seven genomically-defined CLL subgroups that have distinct biological properties, are associated with specific chromosomal deletions and amplifications, and have marked differences in molecular prognostic markers and clinical outcomes. Our results indicate that investigations focusing on small numbers of patient samples likely provide a biased outlook on CLL biology. These findings may have important implications in identifying patients who should be treated with specific targeted therapies, which could have efficacy against CLL cells that rely on specific biological pathways.

Amotivation and functional outcomes in early schizophrenia.

PubMed

Fervaha, Gagan; Foussias, George; Agid, Ofer; Remington, Gary

2013-12-15

Negative symptoms, particularly amotivation/apathy, are intimately tied to functional outcomes. In the present study, apathy strongly predicted psychosocial functioning in a sample of early course schizophrenia patients. This relationship remained robust even after controlling for other clinical variables. These data suggest amotivation is core to functioning across the disease course. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Differentiating progress in a clinical group of fibromyalgia patients during and following a multicomponent treatment program.

PubMed

Van Den Houte, Maaike; Luyckx, Koen; Van Oudenhove, Lukas; Bogaerts, Katleen; Van Diest, Ilse; De Bie, Jozef; Van den Bergh, Omer

2017-07-01

Treatments including multiple nonpharmacological components have beneficial effects on the key symptoms of fibromyalgia, although effects are limited and often do not persist. In this study, we examined different patterns of clinical progress and the dynamic interplay between predictors and outcomes over time. Fibromyalgia patients (N=153; 135 women) followed a multidisciplinary group program spanning 12weeks, aimed at "regaining control over daily functioning". Anxiety, depression, pain coping and kinesiophobia were used as predictor variables. Outcome variables were pain severity, pain-related disability, physical functioning and functional interference. All variables were assessed at 3 moments: on the first and last day of treatment, and 12weeks after the last day of treatment. Overall treatment effects were analyzed using mixed model analyses. Latent class growth analysis identifying different treatment trajectory classes was used to investigate individual differences in treatment effects. Finally, cross-lagged structural equation models were used to investigate the dynamic interplay between predictors and outcomes over time. Only a fourth to a third of the total group showed improvement on the outcome variables. These patients had lower baseline anxiety, depression and kinesiophobia, and improved more on anxiety, depression and kinesiophobia. Physical well-being had a stronger effect on anxiety and depression than vice versa. Physical functioning predicted relative changes in kinesiophobia, while kinesiophobia predicted relative changes in pain-related disability. The results emphasize the importance of tailoring treatments to individual needs in order to improve overall effectiveness of treatment programs. Copyright © 2017. Published by Elsevier Inc.

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.

"Wish You Were Here": Examining Characteristics, Outcomes, and Statistical Solutions for Missing Cases in Web-Based Psychotherapeutic Trials.

PubMed

Karin, Eyal; Dear, Blake F; Heller, Gillian Z; Crane, Monique F; Titov, Nickolai

2018-04-19

Missing cases following treatment are common in Web-based psychotherapy trials. Without the ability to directly measure and evaluate the outcomes for missing cases, the ability to measure and evaluate the effects of treatment is challenging. Although common, little is known about the characteristics of Web-based psychotherapy participants who present as missing cases, their likely clinical outcomes, or the suitability of different statistical assumptions that can characterize missing cases. Using a large sample of individuals who underwent Web-based psychotherapy for depressive symptoms (n=820), the aim of this study was to explore the characteristics of cases who present as missing cases at posttreatment (n=138), their likely treatment outcomes, and compare between statistical methods for replacing their missing data. First, common participant and treatment features were tested through binary logistic regression models, evaluating the ability to predict missing cases. Second, the same variables were screened for their ability to increase or impede the rate symptom change that was observed following treatment. Third, using recontacted cases at 3-month follow-up to proximally represent missing cases outcomes following treatment, various simulated replacement scores were compared and evaluated against observed clinical follow-up scores. Missing cases were dominantly predicted by lower treatment adherence and increased symptoms at pretreatment. Statistical methods that ignored these characteristics can overlook an important clinical phenomenon and consequently produce inaccurate replacement outcomes, with symptoms estimates that can swing from -32% to 70% from the observed outcomes of recontacted cases. In contrast, longitudinal statistical methods that adjusted their estimates for missing cases outcomes by treatment adherence rates and baseline symptoms scores resulted in minimal measurement bias (<8%). Certain variables can characterize and predict missing cases likelihood and jointly predict lesser clinical improvement. Under such circumstances, individuals with potentially worst off treatment outcomes can become concealed, and failure to adjust for this can lead to substantial clinical measurement bias. Together, this preliminary research suggests that missing cases in Web-based psychotherapeutic interventions may not occur as random events and can be systematically predicted. Critically, at the same time, missing cases may experience outcomes that are distinct and important for a complete understanding of the treatment effect. ©Eyal Karin, Blake F Dear, Gillian Z Heller, Monique F Crane, Nickolai Titov. Originally published in JMIR Mental Health (http://mental.jmir.org), 19.04.2018.

“Wish You Were Here”: Examining Characteristics, Outcomes, and Statistical Solutions for Missing Cases in Web-Based Psychotherapeutic Trials

PubMed Central

Dear, Blake F; Heller, Gillian Z; Crane, Monique F; Titov, Nickolai

2018-01-01

Background Missing cases following treatment are common in Web-based psychotherapy trials. Without the ability to directly measure and evaluate the outcomes for missing cases, the ability to measure and evaluate the effects of treatment is challenging. Although common, little is known about the characteristics of Web-based psychotherapy participants who present as missing cases, their likely clinical outcomes, or the suitability of different statistical assumptions that can characterize missing cases. Objective Using a large sample of individuals who underwent Web-based psychotherapy for depressive symptoms (n=820), the aim of this study was to explore the characteristics of cases who present as missing cases at posttreatment (n=138), their likely treatment outcomes, and compare between statistical methods for replacing their missing data. Methods First, common participant and treatment features were tested through binary logistic regression models, evaluating the ability to predict missing cases. Second, the same variables were screened for their ability to increase or impede the rate symptom change that was observed following treatment. Third, using recontacted cases at 3-month follow-up to proximally represent missing cases outcomes following treatment, various simulated replacement scores were compared and evaluated against observed clinical follow-up scores. Results Missing cases were dominantly predicted by lower treatment adherence and increased symptoms at pretreatment. Statistical methods that ignored these characteristics can overlook an important clinical phenomenon and consequently produce inaccurate replacement outcomes, with symptoms estimates that can swing from −32% to 70% from the observed outcomes of recontacted cases. In contrast, longitudinal statistical methods that adjusted their estimates for missing cases outcomes by treatment adherence rates and baseline symptoms scores resulted in minimal measurement bias (<8%). Conclusions Certain variables can characterize and predict missing cases likelihood and jointly predict lesser clinical improvement. Under such circumstances, individuals with potentially worst off treatment outcomes can become concealed, and failure to adjust for this can lead to substantial clinical measurement bias. Together, this preliminary research suggests that missing cases in Web-based psychotherapeutic interventions may not occur as random events and can be systematically predicted. Critically, at the same time, missing cases may experience outcomes that are distinct and important for a complete understanding of the treatment effect. PMID:29674311

Secondary mediation and regression analyses of the PTClinResNet database: determining causal relationships among the International Classification of Functioning, Disability and Health levels for four physical therapy intervention trials.

PubMed

Mulroy, Sara J; Winstein, Carolee J; Kulig, Kornelia; Beneck, George J; Fowler, Eileen G; DeMuth, Sharon K; Sullivan, Katherine J; Brown, David A; Lane, Christianne J

2011-12-01

Each of the 4 randomized clinical trials (RCTs) hosted by the Physical Therapy Clinical Research Network (PTClinResNet) targeted a different disability group (low back disorder in the Muscle-Specific Strength Training Effectiveness After Lumbar Microdiskectomy [MUSSEL] trial, chronic spinal cord injury in the Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury [STOMPS] trial, adult stroke in the Strength Training Effectiveness Post-Stroke [STEPS] trial, and pediatric cerebral palsy in the Pediatric Endurance and Limb Strengthening [PEDALS] trial for children with spastic diplegic cerebral palsy) and tested the effectiveness of a muscle-specific or functional activity-based intervention on primary outcomes that captured pain (STOMPS, MUSSEL) or locomotor function (STEPS, PEDALS). The focus of these secondary analyses was to determine causal relationships among outcomes across levels of the International Classification of Functioning, Disability and Health (ICF) framework for the 4 RCTs. With the database from PTClinResNet, we used 2 separate secondary statistical approaches-mediation analysis for the MUSSEL and STOMPS trials and regression analysis for the STEPS and PEDALS trials-to test relationships among muscle performance, primary outcomes (pain related and locomotor related), activity and participation measures, and overall quality of life. Predictive models were stronger for the 2 studies with pain-related primary outcomes. Change in muscle performance mediated or predicted reductions in pain for the MUSSEL and STOMPS trials and, to some extent, walking speed for the STEPS trial. Changes in primary outcome variables were significantly related to changes in activity and participation variables for all 4 trials. Improvement in activity and participation outcomes mediated or predicted increases in overall quality of life for the 3 trials with adult populations. Variables included in the statistical models were limited to those measured in the 4 RCTs. It is possible that other variables also mediated or predicted the changes in outcomes. The relatively small sample size in the PEDALS trial limited statistical power for those analyses. Evaluating the mediators or predictors of change between each ICF level and for 2 fundamentally different outcome variables (pain versus walking) provided insights into the complexities inherent across 4 prevalent disability groups.

A systematic literature search to identify performance measure outcomes used in clinical studies of racehorses.

PubMed

Wylie, C E; Newton, J R

2018-05-01

Racing performance is often used as a measurable outcome variable in research studies investigating clinical diagnoses or interventions. However, the use of many different performance measures largely precludes conduct of meaningful comparative studies and, to date, those being used have not been collated. To systematically review the veterinary scientific literature for the use of racing performance as a measurable outcome variable in clinical studies of racehorses, collate and identify those most popular, and identify their advantages and disadvantages. Systematic literature search. The search criteria "((racing AND performance) AND (horses OR equidae))" were adapted for both MEDLINE and CAB Abstracts databases. Data were collected in standardised recording forms for binary, categorical and quantitative measures, and the use of performance indices. In total, 217 studies that described racing performance were identified, contributing 117 different performance measures. No one performance measure was used in all studies, despite 90.3% using more than one variable. Data regarding race starts and earnings were used most commonly, with 88.0% and 54.4% of studies including at least one measure of starts and earnings, respectively. Seventeen variables were used 10 times or more, with the top five comprising: 'return to racing', 'number of starts', 'days to first start', 'earnings per period of time' and 'earnings per start'. The search strategies may not have identified all relevant papers, introducing bias to the review. Performance indices have been developed to improve assessment of interventions; however, they are not widely adopted in the scientific literature. Use of the two most commonly identified measures, whether the horse returned to racing and number of starts over a defined period of time, would best facilitate future systematic reviews and meta-analyses in advance of the development of a gold-standard measure of race performance outcome. © 2017 EVJ Ltd.

Clinically meaningful parameters of progression and long-term outcome of Parkinson disease: An international consensus statement.

PubMed

Puschmann, Andreas; Brighina, Laura; Markopoulou, Katerina; Aasly, Jan; Chung, Sun Ju; Frigerio, Roberta; Hadjigeorgiou, Georgios; Kõks, Sulev; Krüger, Rejko; Siuda, Joanna; Wider, Christian; Zesiewicz, Theresa A; Maraganore, Demetrius M

2015-07-01

Parkinson disease (PD) is associated with a clinical course of variable duration, severity, and a combination of motor and non-motor features. Recent PD research has focused primarily on etiology rather than clinical progression and long-term outcomes. For the PD patient, caregivers, and clinicians, information on expected clinical progression and long-term outcomes is of great importance. Today, it remains largely unknown what factors influence long-term clinical progression and outcomes in PD; recent data indicate that the factors that increase the risk to develop PD differ, at least partly, from those that accelerate clinical progression and lead to worse outcomes. Prospective studies will be required to identify factors that influence progression and outcome. We suggest that data for such studies is collected during routine office visits in order to guarantee high external validity of such research. We report here the results of a consensus meeting of international movement disorder experts from the Genetic Epidemiology of Parkinson's Disease (GEO-PD) consortium, who convened to define which long-term outcomes are of interest to patients, caregivers and clinicians, and what is presently known about environmental or genetic factors influencing clinical progression or long-term outcomes in PD. We propose a panel of rating scales that collects a significant amount of phenotypic information, can be performed in the routine office visit and allows international standardization. Research into the progression and long-term outcomes of PD aims at providing individual prognostic information early, adapting treatment choices, and taking specific measures to provide care optimized to the individual patient's needs. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effectiveness of the Lidcombe Program for early stuttering in Australian community clinics.

PubMed

O'Brian, Sue; Iverach, Lisa; Jones, Mark; Onslow, Mark; Packman, Ann; Menzies, Ross

2013-12-01

This study explored the effectiveness of the Lidcombe Program for early stuttering in community clinics. Participants were 31 speech-language pathologists (SLPs) using the Lidcombe Program in clinics across Australia, and 57 of their young stuttering clients. Percentage of syllables stuttered (%SS) was collected 9 months after beginning treatment along with information about variables likely to influence outcomes. The mean %SS for the 57 children 9 months after starting treatment was 1.7. The most significant predictor of outcome was Lidcombe Program Trainers Consortium (LPTC) training. The children of trained SLPs (n = 19), compared to the children of untrained SLPs, took 76% more sessions to complete stage 1, but achieved 54% lower %SS scores, 9 months after starting treatment. Results suggest that outcomes for the Lidcombe Program in the general community may be comparable to those obtained in clinical trials when SLPs receive formal training and support.

The Statin–Iron Nexus: Anti-Inflammatory Intervention for Arterial Disease Prevention

PubMed Central

DePalma, Ralph G.; Shamayeva, Galina; Chow, Bruce K.

2013-01-01

Objectives. We postulated the existence of a statin–iron nexus by which statins improve cardiovascular disease outcomes at least partially by countering proinflammatory effects of excess iron stores. Methods. Using data from a clinical trial of iron (ferritin) reduction in advanced peripheral arterial disease, the Iron and Atherosclerosis Study, we compared effects of ferritin levels versus high-density lipoprotein to low-density lipoprotein ratios (both were randomization variables) on clinical outcomes in participants receiving and not receiving statins. Results. Statins increased high-density lipoprotein to low-density lipoprotein ratios and reduced ferritin levels by noninteracting mechanisms. Improved clinical outcomes were associated with lower ferritin levels but not with improved lipid status. Conclusions. There are commonalities between the clinical benefits of statins and the maintenance of physiologic iron levels. Iron reduction may be a safe and low-cost alternative to statins. PMID:23409890

Trends in Utilization of Surrogate Endpoints in Contemporary Cardiovascular Clinical Trials.

PubMed

Patel, Ravi B; Vaduganathan, Muthiah; Samman-Tahhan, Ayman; Kalogeropoulos, Andreas P; Georgiopoulou, Vasiliki V; Fonarow, Gregg C; Gheorghiade, Mihai; Butler, Javed

2016-06-01

Surrogate endpoints facilitate trial efficiency but are variably linked to clinical outcomes, and limited data are available exploring their utilization in cardiovascular clinical trials over time. We abstracted data regarding primary clinical, intermediate, and surrogate endpoints from all phase II to IV cardiovascular clinical trials from 2001 to 2012 published in the 8 highest Web of Science impact factor journals. Two investigators independently classified the type of primary endpoint. Of the 1,224 trials evaluated, 677 (55.3%) primary endpoints were clinical, 165 (13.5%) intermediate, and 382 (31.2%) surrogate. The relative proportions of these endpoints remained constant over time (p = 0.98). Trials using surrogate endpoints were smaller (187 vs 1,028 patients) and enrolled patients more expeditiously (1.4 vs 0.9 patients per site per month) compared with trials using clinical endpoints (p <0.001 for both comparisons). Surrogate endpoint trials were independently more likely to meet their primary endpoint compared to trials with clinical endpoints (adjusted odds ratio 1.56, 95% CI 1.05 to 2.34; p = 0.03). Rates of positive results in clinical endpoint trials have decreased over time from 66.1% in 2001 to 2003 to 47.2% in 2010 to 2012 (p = 0.001), whereas these rates have remained stable over the same period for surrogate (72.0% to 69.3%, p = 0.27) and intermediate endpoints (74.4% to 71.4%, p = 0.98). In conclusion, approximately a third of contemporary cardiovascular trials use surrogate endpoints. These trials are completed more expeditiously and are more likely to meet their primary outcomes. The overall scientific contribution of these surrogate endpoint trials requires further attention given their variable association with definitive outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Determinants of successful clinical networks: the conceptual framework and study protocol.

PubMed

Haines, Mary; Brown, Bernadette; Craig, Jonathan; D'Este, Catherine; Elliott, Elizabeth; Klineberg, Emily; McInnes, Elizabeth; Middleton, Sandy; Paul, Christine; Redman, Sally; Yano, Elizabeth M

2012-03-13

Clinical networks are increasingly being viewed as an important strategy for increasing evidence-based practice and improving models of care, but success is variable and characteristics of networks with high impact are uncertain. This study takes advantage of the variability in the functioning and outcomes of networks supported by the Australian New South Wales (NSW) Agency for Clinical Innovation's non-mandatory model of clinical networks to investigate the factors that contribute to the success of clinical networks. The objective of this retrospective study is to examine the association between external support, organisational and program factors, and indicators of success among 19 clinical networks over a three-year period (2006-2008). The outcomes (health impact, system impact, programs implemented, engagement, user perception, and financial leverage) and explanatory factors will be collected using a web-based survey, interviews, and record review. An independent expert panel will provide judgements about the impact or extent of each network's initiatives on health and system impacts. The ratings of the expert panel will be the outcome used in multivariable analyses. Following the rating of network success, a qualitative study will be conducted to provide a more in-depth examination of the most successful networks. This is the first study to combine quantitative and qualitative methods to examine the factors that contribute to the success of clinical networks and, more generally, is the largest study of clinical networks undertaken. The adaptation of expert panel methods to rate the impacts of networks is the methodological innovation of this study. The proposed project will identify the conditions that should be established or encouraged by agencies developing clinical networks and will be of immediate use in forming strategies and programs to maximise the effectiveness of such networks.

Host-dependent variables: The missing link to personalized medicine.

PubMed

Demlova, Regina; Zdrazilova-Dubska, Lenka; Sterba, Jaroslav; Stanta, Giorgio; Valik, Dalibor

2018-04-26

Individualized medicine has the potential to tailor anticancer therapy with the best response and highest safety margin to provide better patient care. However, modern targeted therapies are still being tested through clinical trials comparing preselected patient cohorts and assessed upon behaviour of group averages. Clinically manifesting malignant disease requires identification of host- and tumour-dependent variables such as biological characteristics of the tumour and its microenvironment including immune response features, and overall capacity of the host to receive, tolerate and efficiently utilize treatment. Contemporary medical oncology including clinical trial design need to refocus from assessing group averages to individuality taking into consideration time dependent host-associated characteristics and reinventing outliers to be appreciated as naturally occurring variables collectively determining the ultimate outcome of malignant disease. Copyright © 2018. Published by Elsevier Ltd.

Impact of environmental chemicals, sociodemographic variables, depression, and clinical indicators of health and nutrition on self-reported health status

EPA Science Inventory

Public health researchers ideally integrate social, environmental, and clinical measures to identify predictors of poor health. Chemicals measured in human tissues are often evaluated in relation to intangible or rare health outcomes, or are studied one chemical at a time. Using ...

Factors That Help and Hinder Scientific Training in Counseling and Clinical Psychology Students

ERIC Educational Resources Information Center

Marks, Margaret M.

2011-01-01

The purpose of this dissertation is to better understand scientific training within clinical and counseling psychology doctoral programs. A primary goal is to extend previous research by expanding the scientific training outcome variables from research interest and productivity to include additional characteristics of scientific mindedness such as…

Designing clinical trials of interventions for mobility disability: results from the lifestyle interventions and independence for elders pilot (LIFE-P) trial.

PubMed

Espeland, Mark A; Gill, Thomas M; Guralnik, Jack; Miller, Michael E; Fielding, Roger; Newman, Anne B; Pahor, Marco

2007-11-01

Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Results are described from a pilot clinical trial in which 424 volunteers aged 70-89 years were randomly assigned to one of two interventions-physical activity or a healthy aging education program-and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in < or =10 seconds, a physical performance battery, and a questionnaire focused on physical function. Changes in all four outcomes were interrelated over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e., appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A 4-year trial based on the outcome of the 400-meter walk is projected to require N = 962-2234 to detect an intervention effect of 30%-20% with 90% power. Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400-meter walk as their primary outcome.

Variability in objective and subjective measures affects baseline values in studies of patients with COPD

PubMed Central

Ha, Jae Wook; Couper, David J.; O’Neal, Wanda K.; Barr, R. Graham; Bleecker, Eugene R.; Carretta, Elizabeth E.; Cooper, Christopher B.; Doerschuk, Claire M.; Drummond, M Bradley; Han, MeiLan K.; Hansel, Nadia N.; Kim, Victor; Kleerup, Eric C.; Martinez, Fernando J.; Rennard, Stephen I.; Tashkin, Donald; Woodruff, Prescott G.; Paine, Robert; Curtis, Jeffrey L.; Kanner, Richard E.

2017-01-01

Rationale Understanding the reliability and repeatability of clinical measurements used in the diagnosis, treatment and monitoring of disease progression is of critical importance across all disciplines of clinical practice and in clinical trials to assess therapeutic efficacy and safety. Objectives Our goal is to understand normal variability for assessing true changes in health status and to more accurately utilize this data to differentiate disease characteristics and outcomes. Methods Our study is the first study designed entirely to establish the repeatability of a large number of instruments utilized for the clinical assessment of COPD in the same subjects over the same period. We utilized SPIROMICS participants (n = 98) that returned to their clinical center within 6 weeks of their baseline visit to repeat complete baseline assessments. Demographics, spirometry, questionnaires, complete blood cell counts (CBC), medical history, and emphysema status by computerized tomography (CT) imaging were obtained. Results Pulmonary function tests (PFTs) were highly repeatable (ICC’s >0.9) but the 6 minute walk (6MW) was less so (ICC = 0.79). Among questionnaires, the Saint George’s Respiratory Questionnaire (SGRQ) was most repeatable. Self-reported clinical features, such as exacerbation history, and features of chronic bronchitis, often produced kappa values <0.6. Reported age at starting smoking and average number of cigarettes smoked were modestly repeatable (kappa = 0.76 and 0.79). Complete blood counts (CBC) variables produced intraclass correlation coefficients (ICC) values between 0.6 and 0.8. Conclusions PFTs were highly repeatable, while subjective measures and subject recall were more variable. Analyses using features with poor repeatability could lead to misclassification and outcome errors. Hence, care should be taken when interpreting change in clinical features based on measures with low repeatability. Efforts to improve repeatability of key clinical features such as exacerbation history and chronic bronchitis are warranted. PMID:28934249

Controlled clinical trial of cannabidiol in Huntington's disease.

PubMed

Consroe, P; Laguna, J; Allender, J; Snider, S; Stern, L; Sandyk, R; Kennedy, K; Schram, K

1991-11-01

Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.

High interpatient variability of treosulfan exposure is associated with early toxicity in paediatric HSCT: a prospective multicentre study.

PubMed

van der Stoep, M Y Eileen C; Bertaina, Alice; Ten Brink, Marloes H; Bredius, Robbert G; Smiers, Frans J; Wanders, Dominique C M; Moes, Dirk Jan A R; Locatelli, Franco; Guchelaar, Henk-Jan; Zwaveling, Juliëtte; Lankester, Arjan C

2017-12-01

Treosulfan-based conditioning is increasingly employed in paediatric haematopoietic stem cell transplantation (HSCT). Data on treosulfan pharmacokinetics in children are scarce, and the relationship between treosulfan exposure, toxicity and clinical outcome is unresolved. In this multicentre prospective observational study, we studied treosulfan pharmacokinetics and the drug's relationship with regimen-related toxicity and early clinical outcome in 77 paediatric patients. Treosulfan dose was 30 g/m 2 , administered over 3 consecutive days in infants <1 year old (n = 12) and 42 g/m 2 in children ≥1 year old (n = 65). Mean day 1 treosulfan exposure was 1744 ± 795 mg*h/l (10 g/m 2 ) and 1561 ± 511 mg*h/l (14 g/m 2 ), with an inter-individual variability of 56 and 33% in the respective groups. High treosulfan exposure (>1650 mg*h/l) was associated with an increased risk of mucosal [Odds ratio (OR) 4·40; 95% confidence interval (CI) 1·19-16·28, P = 0·026] and skin toxicity (OR 4·51; 95% CI 1·07-18·93, P = 0·040). No correlation was found between treosulfan exposure and the early clinical outcome parameters: engraftment, acute graft-versus-host disease and donor chimerism. Our study provides the first evidence in a large cohort of paediatric patients of high variability in treosulfan pharmacokinetics and an association between treosulfan exposure and early toxicity. Ongoing studies will reveal whether treosulfan exposure is related to long-term disease-specific outcome and late treatment-related toxicity. © 2017 John Wiley & Sons Ltd.

The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients.

PubMed

Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun

2016-05-01

Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients.HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization.A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan-Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21-2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00-1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12-2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08-2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables.Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients.

Challenges in Measuring Outcomes Following Digital Replantation

PubMed Central

Sebastin, Sandeep J.; Chung, Kevin C.

2013-01-01

In the early period of replantation surgery, the emphasis was on digit survival. Subsequently, with better microsurgical techniques and instrumentation, the focus has shifted to function and in recent years to consideration of cost-effectiveness. Despite over 40 years of effort in refining digital replantation surgery, a rigorous evaluation of the outcomes of digital replantation has not been performed. This is because of the many confounding variables that influence outcome comparisons. These variables include the mechanism of injury (guillotine, crush, avulsion), the injury itself (total, near total, subtotal, partial amputation), and the surgical procedure (replantation, revascularization). In addition, the traditional outcome measures (two-point discrimination, range of motion, grip strength, or the ability to return to work) are reported inconsistently and vary widely among publications. All these factors make meaningful comparison of outcomes difficult. The recent emphasis on outcome research and cost-effectiveness necessitates a rethinking in the way we report outcomes of digital replantation. In this article, the authors summarize the challenges in assessing outcomes of digital replantation and explain the need to measure outcomes using rigorous clinical research designs that incorporate cost-effectiveness studies in the research protocol. PMID:24872766

Treatment of scalp psoriasis with clobetasol-17 propionate 0.05% shampoo: a study on daily clinical practice.

PubMed

Bovenschen, H J; Van de Kerkhof, P C M

2010-04-01

Safety and clinical effectiveness of clobetasol-17 propionate 0.05% shampoo have been shown in patients with scalp psoriasis. First, to evaluate treatment satisfaction, user convenience safety and effectiveness of clobetasol-17 propionate 0.05% shampoo treatment in daily clinical practice. Second, to identify subgroup variables that may predict treatment success or failure. A total of 56 patients with scalp psoriasis were treated with short-contact clobetasol-17 propionate 0.05% shampoo once daily for 4 weeks. Data on treatment satisfaction, user convenience, safety and effectiveness were assessed on a 7-point Likert scale using postal questionnaires. Subgroup analyses were performed to identify variables that may predict treatment outcome. A total of 41 patients returned both questionnaires (73%). Positive treatment satisfaction and user convenience were reported by 66% and 79% of patients respectively. Patient-rated indicators for disease severity improved by 39-46% (P < 0.05%). No major side-effects were reported. Subgroup analyses did not reveal any statistically significant patient variable that may predict treatment outcome. However, a tendency towards improved treatment satisfaction was observed in patients who had received fewer topical antipsoriatic treatments previously (P > 0.05). Short-contact treatment with clobetasol-17 propionate 0.05% shampoo has high user convenience and patient satisfaction rates. Moreover, the treatment is well-tolerated and efficacious from patients' perspective. Subgroup analyses did not reveal factors predicting treatment outcome, although treatment success tended to be more evident in patients who had received fewer treatments previously.

Changes in patellofemoral alignment do not cause clinical impact after open-wedge high tibial osteotomy.

PubMed

Lee, Yong Seuk; Lee, Sang Bok; Oh, Won Seok; Kwon, Yong Eok; Lee, Beom Koo

2016-01-01

The objectives of this study were (1) to evaluate the clinical and radiologic outcomes of open-wedge high tibial osteotomy focusing on patellofemoral alignment and (2) to search for correlation between variables and patellofemoral malalignment. A total of 46 knees (46 patients) from 32 females and 14 males who underwent open-wedge high tibial osteotomy were included in this retrospective case series. Outcomes were evaluated using clinical scales and radiologic parameters at the last follow-up. Pre-operative and final follow-up values were compared for the outcome analysis. For the focused analysis of the patellofemoral joint, correlation analyses between patellofemoral variables and pre- and post-operative weight-bearing line (WBL), clinical score, posterior slope, Blackburn Peel ratio, lateral patellar tilt, lateral patellar shift, and congruence angle were performed. The minimum follow-up period was 2 years and median follow-up period was 44 months (range 24-88 months). The percentage of weight-bearing line was shifted from 17.2 ± 11.1 to 56.7 ± 12.7%, and it was statistically significant (p < 0.01). Regarding the clinical results, statistical significance was observed using all scores (p < 0.01). In the radiologic evaluation, patellar descent was observed with statistical significance (p < 0.01). Last follow-up lateral patellar tilt was decreased with statistical significance (p < 0.01). In correlation analysis between variables of patellofemoral malalignment, the pre-operative weight-bearing line showed an association with the change in lateral patellar tilt and lateral patellar shift (correlation coefficient: 0.3). After open-wedge high tibial osteotomy, clinical results showed improvement, compared to pre-operative values. The patellar tilt and lateral patellar shift were not changed; however, descent of the patella was observed. Therefore, mild patellofemoral problems should not be a contraindication of the open-wedge high tibial osteotomy. Case series, Level IV.

Quantification of myocardium at risk in ST- elevation myocardial infarction: a comparison of contrast-enhanced steady-state free precession cine cardiovascular magnetic resonance with coronary angiographic jeopardy scores.

PubMed

De Palma, Rodney; Sörensson, Peder; Verouhis, Dinos; Pernow, John; Saleh, Nawzad

2017-07-27

Clinical outcome following acute myocardial infarction is predicted by final infarct size evaluated in relation to left ventricular myocardium at risk (MaR). Contrast-enhanced steady-state free precession (CE-SSFP) cardiovascular magnetic resonance imaging (CMR) is not widely used for assessing MaR. Evidence of its utility compared to traditional assessment methods and as a surrogate for clinical outcome is needed. Retrospective analysis within a study evaluating post-conditioning during ST elevation myocardial infarction (STEMI) treated with coronary intervention (n = 78). CE-SSFP post-infarction was compared with angiographic jeopardy methods. Differences and variability between CMR and angiographic methods using Bland-Altman analyses were evaluated. Clinical outcomes were compared to MaR and extent of infarction. MaR showed correlation between CE-SSFP, and both BARI and APPROACH scores of 0.83 (p < 0.0001) and 0.84 (p < 0.0001) respectively. Bias between CE-SSFP and BARI was 1.1% (agreement limits -11.4 to +9.1). Bias between CE-SSFP and APPROACH was 1.2% (agreement limits -13 to +10.5). Inter-observer variability for the BARI score was 0.56 ± 2.9; 0.42 ± 2.1 for the APPROACH score; -1.4 ± 3.1% for CE-SSFP. Intra-observer variability was 0.15 ± 1.85 for the BARI score; for the APPROACH score 0.19 ± 1.6; and for CE-SSFP -0.58 ± 2.9%. Quantification of MaR with CE-SSFP imaging following STEMI shows high correlation and low bias compared with angiographic scoring and supports its use as a reliable and practical method to determine myocardial salvage in this patient population. Clinical trial registration information for the parent clinical trial: Karolinska Clinical Trial Registration (2008) Unique identifier: CT20080014. Registered 04 th January 2008.

Prediction of Primary Care Depression Outcomes at Six Months: Validation of DOC-6 ©.

PubMed

Angstman, Kurt B; Garrison, Gregory M; Gonzalez, Cesar A; Cozine, Daniel W; Cozine, Elizabeth W; Katzelnick, David J

2017-01-01

The goal of this study was to develop and validate an assessment tool for adult primary care patients diagnosed with depression to determine predictive probability of clinical outcomes at 6 months. We retrospectively reviewed 3096 adult patients enrolled in collaborative care management (CCM) for depression. Patients enrolled on or before December 31, 2013, served as the training set (n = 2525), whereas those enrolled after that date served as the preliminary validation set (n = 571). Six variables (2 demographic and 4 clinical) were statistically significant in determining clinical outcomes. Using the validation data set, the remission classifier produced the receiver operating characteristics (ROC) curve with a c-statistic or area under the curve (AUC) of 0.62 with predicted probabilities than ranged from 14.5% to 79.1%, with a median of 50.6%. The persistent depressive symptoms (PDS) classifier produced an ROC curve with a c-statistic or AUC of 0.67 and predicted probabilities that ranged from 5.5% to 73.1%, with a median of 23.5%. We were able to identify readily available variables and then validated these in the prediction of depression remission and PDS at 6 months. The DOC-6 tool may be used to predict which patients may be at risk for worse outcomes. © Copyright 2017 by the American Board of Family Medicine.

Medicine Based Evidence for Individualized Decision Making: Case Study of Systemic Lupus Erythematosus.

PubMed

Wivel, Ashley E; Lapane, Kate; Kleoudis, Christi; Singer, Burton H; Horwitz, Ralph I

2017-11-01

To guide management decisions for an index patient, evidence is required from comparisons between approximate matches to the profile of the index case, where some matches contain responses to treatment and others act as controls. We describe a method for constructing clinically relevant histories/profiles using data collected but unreported from 2 recent phase 3 randomized controlled trials assessing belimumab in subjects with clinically active and serologically positive systemic lupus erythematosus. Outcome was the Systemic lupus erythematosus Responder Index (SRI) measured at 52 weeks. Among 1175 subjects, we constructed an algorithm utilizing 11 trajectory variables including 4 biological, 2 clinical, and 5 social/behavioral. Across all biological and social/behavioral variables, the proportion of responders based on the SRI whose value indicated clinical worsening or no improvement ranged from 27.5% to 42.3%. Kappa values suggested poor agreement, indicating that each biological and patient-reported outcome provides different information than gleaned from the SRI. The richly detailed patient profiles needed to guide decision-making in clinical practice are sharply at odds with the limited information utilized in conventional randomized controlled trial analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications–a cross-sectional study

PubMed Central

Earley, Amy; Lau, Joseph; Uhlig,, Katrin

2013-01-01

Context A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. Objective To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Design Registry-based study of clinical trial results reporting. Setting ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. Selection criteria A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. Main outcome measure ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. Results In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Conclusions Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications. PMID:23335556

Timing matters: change depends on the stage of treatment in cognitive behavioral therapy for panic disorder with agoraphobia.

PubMed

Gloster, Andrew T; Klotsche, Jens; Gerlach, Alexander L; Hamm, Alfons; Ströhle, Andreas; Gauggel, Siegfried; Kircher, Tilo; Alpers, Georg W; Deckert, Jürgen; Wittchen, Hans-Ulrich

2014-02-01

The mechanisms of action underlying treatment are inadequately understood. This study examined 5 variables implicated in the treatment of panic disorder with agoraphobia (PD/AG): catastrophic agoraphobic cognitions, anxiety about bodily sensations, agoraphobic avoidance, anxiety sensitivity, and psychological flexibility. The relative importance of these process variables was examined across treatment phases: (a) psychoeducation/interoceptive exposure, (b) in situ exposure, and (c) generalization/follow-up. Data came from a randomized controlled trial of cognitive behavioral therapy for PD/AG (n = 301). Outcomes were the Panic and Agoraphobia Scale (Bandelow, 1995) and functioning as measured in the Clinical Global Impression scale (Guy, 1976). The effect of process variables on subsequent change in outcome variables was calculated using bivariate latent difference score modeling. Change in panic symptomatology was preceded by catastrophic appraisal and agoraphobic avoidance across all phases of treatment, by anxiety sensitivity during generalization/follow-up, and by psychological flexibility during exposure in situ. Change in functioning was preceded by agoraphobic avoidance and psychological flexibility across all phases of treatment, by fear of bodily symptoms during generalization/follow-up, and by anxiety sensitivity during exposure. The effects of process variables on outcomes differ across treatment phases and outcomes (i.e., symptomatology vs. functioning). Agoraphobic avoidance and psychological flexibility should be investigated and therapeutically targeted in addition to cognitive variables. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Articular congruity is associated with short-term clinical outcomes of operatively treated SER IV ankle fractures.

PubMed

Berkes, Marschall B; Little, Milton T M; Lazaro, Lionel E; Pardee, Nadine C; Schottel, Patrick C; Helfet, David L; Lorich, Dean G

2013-10-02

With regard to supination-external rotation type-IV (SER IV) ankle fractures, there is no consensus regarding which patient, injury, and treatment variables most strongly influence clinical outcome. The purpose of this investigation was to examine the impact of articular surface congruity on the functional outcomes of operatively treatment of SER IV ankle fractures. A prospectively generated database consisting of operatively treated SER IV ankle fractures was reviewed. Postoperative computed tomography (CT) scans were used to assess ankle joint congruity. Ankles were considered incongruent in the presence of >2 mm of articular step-off, intra-articular loose bodies, or an articular surface gap of >2 mm (despite an otherwise anatomic reduction) due to joint impaction and comminution. Patients with at least one year of clinical follow-up were eligible for analysis. The primary and secondary outcome measures were the Foot and Ankle Outcome Score (FAOS) and ankle motion. One hundred and eight SER IV fractures met our inclusion criteria. The average duration of follow-up was twenty-one months. Seventy-two patients (67%) had a congruent ankle joint, and thirty-six (33%) had elements of articular surface incongruity on postoperative CT scanning. These two groups were similar with regard to comorbidities and injury and treatment variables. At the time of the final follow-up, the group with articular incongruity had a significantly worse FAOS with regard to symptoms (p = 0.012), pain (p = 0.004), and activities of daily living (p = 0.038). Those with articular incongruity had worse average scores in the FAOS sport domain as well. No significant differences in ankle motion were found between the two groups. In this population of patients with an operatively treated SER IV ankle fracture, the presence of postoperative articular incongruity correlated with inferior early clinical outcomes. Orthopaedic surgeons should scrutinize ankle fracture reductions and strive for perfection to allow for the best possible clinical outcome. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Clinical Outcome Reporting in Youth ACL Literature Is Widely Variable

PubMed Central

Brusalis, Christopher M.; Lakomkin, Nikita; Suryavanshi, Joash R.; Cruz, Aristides I.; Green, Daniel W.; Jones, Kristofer J.; Fabricant, Peter D.

2017-01-01

Background: Advances in anterior cruciate ligament (ACL) reconstruction procedures in pediatric and adolescent patients have resulted in an increase in recent clinical studies on this topic. However, the consistency with which outcome measures are reported in this demographic is unknown. Purpose: To document outcome reporting patterns of youth ACL reconstruction studies in high-impact journals. Study Design: Systematic review; Level of evidence, 4. Methods: All articles published in 5 high-impact orthopaedic journals from 2010 to 2016 were reviewed to identify those reporting clinical outcomes of young patients who underwent ACL reconstruction. Studies that were nonclinical, reported on patients older than 18 years, or included fewer than 10 patients were excluded. Outcome measures used in all included studies were recorded. Results: Seventeen studies encompassing 772 subjects (mean age, 14.3 years; range, 6.3-18.0 years) were analyzed. Eight studies (47%) reported on Tanner stage of subjects, while 1 study reported skeletal age. Ten studies (59%) clearly documented the presence or absence of surgical complications. Range of motion was reported in 65% of studies. Leg-length discrepancy and angular deformity were each reported in 76% of studies, with 12% quantifying results through radiographic measurements. Ligament testing was variably defined by inclusion of instrumented testing (65%), Lachman test (53%), and pivot-shift test (53%). Fourteen studies (82%) explicitly reported on the rate of ACL rerupture, while 71% reported on the rate of revision surgery. Rate of return to preinjury activity was reported in 8 studies (47%), of which 2 defined criteria for return to sport and 3 defined the level of competitive sport. Patient-reported outcome measures (PROMs) were used variably. For the 3 most commonly reported PROMs (Lysholm, International Knee Documentation Committee, and Tegner), 24% of studies reported all 3 PROMs, 35% of studies reported 2 PROMs, and 6% of studies reported 1 PROM in isolation. A pediatric-specific PROM was reported in 1 of the 17 studies. Conclusion: Studies on pediatric ACL reconstruction published in high-impact journals unreliably defined subjects’ skeletal maturity, inconsistently reported on objective outcome measures, and used disparate adult-validated PROMs to assess subjective outcomes. These findings highlight the need for standardized, pediatric-specific outcome measures to be applied in future studies evaluating ACL reconstruction in children and adolescents. PMID:28840156

Clinical Outcome after Intra-Arterial Stroke Therapy in the Very Elderly: Why is it so Heterogeneous?

PubMed Central

Chandra, Ronil V.; Leslie-Mazwi, Thabele M.; Mehta, Brijesh P.; Yoo, Albert J.; Simonsen, Claus Z.

2014-01-01

Very elderly patients (i.e., ≥80 years) are disproportionally affected by acute ischemic stroke. They account for a third of hospital stroke admissions, but two-thirds of overall stroke-related morbidity and mortality. There is some evidence of clinical benefit in treating selected very elderly patients with intravenous thrombolysis (IVT). For very elderly patients ineligible or non-responsive to IVT, intra-arterial therapy (IAT) may have promise in improving clinical outcome. However, its unequivocal efficacy in the general population remains to be proven in randomized trials. Small cohort studies reveal that the rate of good clinical outcome for very elderly patients after IAT is highly variable, ranging from 0 to 28%. In addition, they experience higher rates of futile reperfusion than younger patients. Thus, it is imperative to understand the factors that impact on clinical outcome in very elderly patients after IAT. The aim of this review is to examine the factors that may be responsible for the heterogeneous clinical response of the very elderly to IAT. This will allow the reader to integrate the current available evidence to individualize intra-arterial stroke therapy in very elderly patients. Placing emphasis on pre-stroke independent living, smaller infarct core size, short procedure times, and avoiding general anesthesia where feasible, will help improve rates of good clinical outcome. PMID:24808887

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.

Effects of post-migration factors on PTSD outcomes among immigrant survivors of political violence.

PubMed

Chu, Tracy; Keller, Allen S; Rasmussen, Andrew

2013-10-01

This study examined the predictors of posttraumatic stress disorder (PTSD) in a clinical sample of 875 immigrant survivors of political violence resettled in the United States, with a specific aim of comparing the relative predictive power of pre-migration and post-migration experiences. Results from a hierarchical OLS regression indicated that pre-migration experiences such as rape/sexual assault were significantly associated with worse PTSD outcomes, as were post-migration factors such as measures of financial and legal insecurity. Post-migration variables, which included immigration status in the US, explained significantly more variance in PTSD outcomes than premigration variables alone. Discussion focused on the importance of looking at postmigration living conditions when treating trauma in this population.

Unpacking cultural factors in adaptation to type 2 diabetes mellitus.

PubMed

Walsh, Michele E; Katz, Murray A; Sechrest, Lee

2002-01-01

Race and ethnicity are used as predictors of outcome in health services research. Often, however, race and ethnicity serve merely as proxies for the resources, values, beliefs, and behaviors (ie, ecology and culture) that are assumed to correlate with them. "Unpacking" proxy variables-directly measuring the variables believed to underlie them-would provide a more reliable and more interpretable way of looking at group differences. To assess the use of a measure of ecocultural domains that is correlated with ethnicity in accounting for variance in adherence, quality of life, clinical outcomes, and service utilization. A cross-sectional observational study. Twenty-six Hispanic and 29 non-Hispanic white VA primary care patients with type 2 diabetes mellitus. The independent variables were patient ethnicity and a summed score of ecocultural domains representing patient adaptation to illness. The outcomes were adherence to treatment, health-related quality of life, clinical indicators of disease management, and utilization of urgent health care services. Patient adaptation was correlated with ethnicity and accounted for more variance in all outcomes than did ethnicity. The unique variance accounted for by adaptation was small to moderate, whereas that accounted for by ethnicity was negligible. It is possible to identify and measure ecocultural domains that better account for variation in important health services outcomes for patients with type 2 diabetes than does ethnicity. Going beyond the study of ethnic differences alone and measuring the correlated factors that play a role in disease management can advance understanding of the phenomena involved in this variation and provide better direction for service design and delivery.

Awareness and attitude of the public toward personalized medicine in Korea

PubMed Central

Lee, Iyn-Hyang; Kang, Hye-Young; Suh, Hae Sun; Lee, Sukhyang; Oh, Eun Sil

2018-01-01

Objectives As personalized medicine (PM) is expected to greatly improve health outcomes, efforts have recently been made for its clinical implementation in Korea. We aimed to evaluate public awareness and attitude regarding PM. Methods We performed a self-administered questionnaire survey to 703 adults, who participated in the survey on a voluntary basis. The primary outcome measures included public knowledge, attitude, and acceptance of PM. We conducted multinomial multivariate logistic analysis for outcome variables with three response categories and performed multivariate logistic regression analyses for dichotomous outcome variables. Results Only 28% of participants had knowledge that genetic factors can contribute to inter-individual variations in drug response and the definition of PM (199 out of 702). Higher family income was correlated with greater knowledge concerning PM (OR = 3.76, p = 0.034). A majority of respondents preferred integrated pharmacogenomic testing over drug-specific testing and agreed to inclusion of pharmacogenomic testing in the national health examination (64% and 77%, respectively), but only 51% were willing to pay for it. Discussion Our results identify the urgent need for public education as well as the potential health disparities in access to PM. This study helps to frame policies for implementing PM in clinical practice. PMID:29451916

Quality improvement in neonatal care - a new paradigm for developing countries.

PubMed

Chawla, Deepak; Suresh, Gautham K

2014-12-01

Infrastructure for facility-based neonatal care has rapidly grown in India over last few years. Experience from developed countries indicates that different health facilities have varying clinical outcomes despite accounting for differences in illness severity of admitted neonates and random variation. Variation in quality of care provided at different neonatal units may account for variable clinical outcomes. Monitoring quality of care, comparing outcomes across different centers and conducting collaborative quality improvement projects can improve outcome of neonates in health facilities. Top priority should be given to establishing quality monitoring and improvement procedures at special care neonatal units and neonatal intensive care units of the country. This article presents an overview of methods of quality improvement. Literature reports of successful collaborative quality improvement projects in neonatal health are also reviewed.

Understanding Disproportionate Representation in Special Education by Examining Group Differences in Behavior Ratings

ERIC Educational Resources Information Center

Peters, Christina D.; Kranzler, John H.; Algina, James; Smith, Stephen W.; Daunic, Ann P.

2014-01-01

The aim of the current study was to examine mean-group differences on behavior rating scales and variables that may predict such differences. Sixty-five teachers completed the Clinical Assessment of Behavior-Teacher Form (CAB-T) for a sample of 982 students. Four outcome variables from the CAB-T were assessed. Hierarchical linear modeling was used…

Detection and evaluation of ventricular repolarization alternans: an approach to combined ECG, thoracic impedance, and beat-to-beat heart rate variability analysis.

PubMed

Kriščiukaitis, Algimantas; Šimoliūnienė, Renata; Macas, Andrius; Petrolis, Robertas; Drėgūnas, Kęstutis; Bakšytė, Giedrė; Pieteris, Linas; Bertašienė, Zita; Žaliūnas, Remigijus

2014-01-01

Beat-to-beat alteration in ventricles repolarization reflected by alternans of amplitude and/or shape of ECG S-T,T segment (TWA) is known as phenomena related with risk of severe arrhythmias leading to sudden cardiac death. Technical difficulties have caused limited its usage in clinical diagnostics. Possibilities to register and analyze multimodal signals reflecting heart activity inspired search for new technical solutions. First objective of this study was to test whether thoracic impedance signal and beat-to-beat heart rate reflect repolarization alternans detected as TWA. The second objective was revelation of multimodal signal features more comprehensively representing the phenomena and increasing its prognostic usefulness. ECG, and thoracic impedance signal recordings made during 24h follow-up of the patients hospitalized in acute phase of myocardial infarction were used for investigation. Signal morphology variations reflecting estimates were obtained by the principal component analysis-based method. Clinical outcomes of patients (survival and/or rehospitalization in 6 and 12 months) were compared to repolarization alternans and heart rate variability estimates. Repolarization alternans detected as TWA was also reflected in estimates of thoracic impedance signal shape and variation in beat-to-beat heart rate. All these parameters showed correlation with clinical outcomes of patients. The strongest significant correlation showed magnitude of alternans in estimates of thoracic impedance signal shape. The features of ECG, thoracic impedance signal and beat-to-beat variability of heart rate, give comprehensive estimates of repolarization alternans, which correlate, with clinical outcomes of the patients and we recommend using them to improve diagnostic reliability. Copyright © 2014 Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

ICD-10 mental and behavioural disorders due to use of crack and powder cocaine as treated at a public psychiatric emergency service: an analysis of visit predictors.

PubMed

da Cruz, Thalita Alves; da Cunha, Gustavo Nunes; de Moraes, Vinicius Papa Milani; Massarini, Renata; Yoshida, Camila Mie Kawata; Tenguam, Patrícia Tomiatto; Garcia, Marcelo Valeiro; Varoto, Daniela Arruda; de Oliveira, Murilo Barutti; de Andrade, Arthur Guerra; de Azevedo-Marques Périco, Cíntia; do Nascimento, Vania Barbosa; Castaldelli-Maia, João Mauricio

2014-08-01

The present study investigated the predictors of an increased number of visits from individuals with some of the diagnoses noted in chapter F14 of ICD-10, from calls to the emergency psychiatric unit of a general hospital in São Paulo state, Brazil, in the period 2011-2012. Poisson regression models were carried out for the outcome variable, accounting for number of subsequent visits to the psychiatric emergency unit. For the analysis of this outcome we took into account the exposure time of each individual in the study. Our findings point to a population at risk for frequent psychiatric emergency service visits: individuals over 25 years. This population should be targeted for interventions on entry into public healthcare due to increased psychiatric morbidity and greater clinical morbidity already confirmed by previous studies. We discussed the need of these individuals for special attention during the clinical or psychiatric emergency consultation which, unfortunately, may be the access point for the public health system. None of the other variables were related to the outcome of interest, such as those related to the level of individual entry into the care network before and after treatment, and other variables related to medical acts during the visit.

Predictors of course and outcome in hypochondriasis after cognitive-behavioral treatment.

PubMed

Hiller, Wolfgang; Leibbrand, Rolf; Rief, Winfried; Fichter, Manfred M

2002-01-01

Predictors of treatment outcome were evaluated in a clinical sample suffering from hypochondriasis. The sample consisted of 96 patients with hypochondriacal disorder according to DSM-IV or high syndrome scores on the Illness Attitude Scales (IAS) or Whiteley Index (WI). After intense inpatient cognitive-behavioral treatment (CBT), 60% of the patients were classified as responders because of substantial improvements or recovery from hypochondriacal symptomatology. Non-responders were characterized by a higher degree of pre-treatment hypochondriasis, more somatization symptoms and general psychopathology (SCL-90R), more dysfunctional cognitions related to bodily functioning, higher levels of psychosocial impairments, and more utilization of the health care system as indicated by the number of hospital days and costs for inpatient treatments and medication. No predictive value was found for sociodemographic variables, comorbidity with other mental disorders and chronicity. Multiple linear regression showed that pre-treatment variables significantly predicted IAS scores at post-treatment (R(2) = 0.59), changes during treatment (0.10), IAS scores at follow-up two years later (0.41) and changes between baseline and follow-up (0.25). The results demonstrate the relevance of various psychopathological variables and health care utilization as important indicators for outcome and further course of clinical hypochondriasis. Copyright 2002 S. Karger AG, Basel

Variable reporting of functional outcomes and return to play in superior labrum anterior and posterior tear.

PubMed

Steinhaus, Michael E; Makhni, Eric C; Lieber, Adam C; Kahlenberg, Cynthia A; Gulotta, Lawrence V; Romeo, Anthony A; Verma, Nikhil N

2016-11-01

Outcomes assessments after superior labrum anterior and posterior (SLAP) tear/repair are highly varied, making it difficult to draw comparisons across the literature. This study examined the inconsistency in outcomes reporting in the SLAP tear literature. We hypothesize that there is significant variability in outcomes reporting and that although most studies may report return to play, time to return reporting will be highly variable. The PubMed, Medline, Scopus, and Embase databases were systematically reviewed for studies from January 2000 to December 2014 reporting outcomes after SLAP tear/repair. Two reviewers assessed each study, and those meeting inclusion criteria were examined for pertinent data. Outcomes included objective (range of motion, strength, clinical examinations, and imaging) and subjective (patient-reported outcomes, satisfaction, activities of daily living, and return to play) measures. Of the 56 included studies, 43% documented range of motion, 14% reported strength, and 16% noted postoperative imaging. There was significant variation in use of patient-reported outcomes measures, with the 3 most commonly noted measures reported in 20% to 55% of studies. Return to play was noted in 75% of studies, and 23% reported time to return, with greater rates in elite athletes. Eleven studies (20%) did not report follow-up or noted data with <12 months of follow-up. The SLAP literature is characterized by substantial variability in outcomes reporting, with time to return to play noted in few studies. Efforts to standardize outcomes reporting would facilitate comparisons across the literature and improve our understanding of the prognosis of this injury. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

The variability in Oxford hip and knee scores in the preoperative period: is there an ideal time to score?

PubMed

Quah, C; Holmes, D; Khan, T; Cockshott, S; Lewis, J; Stephen, A

2018-01-01

Background All NHS-funded providers are required to collect and report patient-reported outcome measures for hip and knee arthroplasty. Although there are established guidelines for timing such measures following arthroplasty, there are no specific time-points for collection in the preoperative period. The primary aim of this study was to identify whether there was a significant amount of variability in the Oxford hip and knee scores prior to surgical intervention when completed in the outpatient clinic at the time of listing for arthroplasty or when completed at the preoperative assessment clinic. Methods A prospective cohort study of patients listed for primary hip or knee arthroplasty was conducted. Patients were asked to fill in a preoperative Oxford score in the outpatient clinic at the time of listing. They were then invited to fill in the official outcome measures questionnaire at the preoperative assessment clinic. The postoperative Oxford score was then completed when the patient was seen again at their postoperative follow up in clinic. Results Of the total of 109 patients included in this study period, there were 18 (17%) who had a worse score of 4 or more points difference and 43 (39.4%) who had an improvement of 4 or more points difference when the scores were compared between time of listing at the outpatient and at the preoperative assessment clinic. There was a statistically significant difference (P = 0.0054) in the mean Oxford scores. Conclusions The results of our study suggest that there should be standardisation of timing for completing the preoperative patient-reported outcome measures.

A Study of Clinical Coding Accuracy in Surgery: Implications for the Use of Administrative Big Data for Outcomes Management.

PubMed

Nouraei, S A R; Hudovsky, A; Frampton, A E; Mufti, U; White, N B; Wathen, C G; Sandhu, G S; Darzi, A

2015-06-01

Clinical coding is the translation of clinical activity into a coded language. Coded data drive hospital reimbursement and are used for audit and research, and benchmarking and outcomes management purposes. We undertook a 2-center audit of coding accuracy across surgery. Clinician-auditor multidisciplinary teams reviewed the coding of 30,127 patients and assessed accuracy at primary and secondary diagnosis and procedure levels, morbidity level, complications assignment, and financial variance. Postaudit data of a randomly selected sample of 400 cases were reaudited by an independent team. At least 1 coding change occurred in 15,402 patients (51%). There were 3911 (13%) and 3620 (12%) changes to primary diagnoses and procedures, respectively. In 5183 (17%) patients, the Health Resource Grouping changed, resulting in income variance of £3,974,544 (+6.2%). The morbidity level changed in 2116 (7%) patients (P < 0.001). The number of assigned complications rose from 2597 (8.6%) to 2979 (9.9%) (P < 0.001). Reaudit resulted in further primary diagnosis and procedure changes in 8.7% and 4.8% of patients, respectively. The coded data are a key engine for knowledge-driven health care provision. They are used, increasingly at individual surgeon level, to benchmark performance. Surgical clinical coding is prone to subjectivity, variability, and error (SVE). Having a specialty-by-specialty understanding of the nature and clinical significance of informatics variability and adopting strategies to reduce it, are necessary to allow accurate assumptions and informed decisions to be made concerning the scope and clinical applicability of administrative data in surgical outcomes improvement.

Clinical, laboratory, and hemostatic findings in cats with naturally occurring sepsis.

PubMed

Klainbart, Sigal; Agi, Limor; Bdolah-Abram, Tali; Kelmer, Efrat; Aroch, Itamar

2017-11-01

OBJECTIVE To characterize clinical and laboratory findings in cats with naturally occurring sepsis, emphasizing hemostasis-related findings, and evaluate these variables for associations with patient outcomes. DESIGN Prospective, observational, clinical study. ANIMALS 31 cats with sepsis and 33 healthy control cats. PROCEDURES Data collected included history; clinical signs; results of hematologic, serum biochemical, and hemostatic tests; diagnosis; and outcome (survival vs death during hospitalization or ≤ 30 days after hospital discharge). Differences between cats with and without sepsis and associations between variables of interest and death were analyzed statistically. RESULTS The sepsis group included cats with pyothorax (n = 10), septic peritonitis (7), panleukopenia virus infection (5), bite wounds (5), abscesses and diffuse cellulitis (3), and pyometra (1). Common clinical abnormalities included dehydration (21 cats), lethargy (21), anorexia (18), pale mucous membranes (15), and dullness (15). Numerous clinicopathologic abnormalities were identified in cats with sepsis; novel findings included metarubricytosis, hypertriglyceridemia, and high circulating muscle enzyme activities. Median activated partial thromboplastin time and plasma D-dimer concentrations were significantly higher, and total protein C and antithrombin activities were significantly lower, in the sepsis group than in healthy control cats. Disseminated intravascular coagulopathy was uncommon (4/22 [18%] cats with sepsis). None of the clinicopathologic abnormalities were significantly associated with death on multivariate analysis. CONCLUSIONS AND CLINICAL RELEVANCE Cats with sepsis had multiple hematologic, biochemical, and hemostatic abnormalities on hospital admission, including several findings suggestive of hemostatic derangement. Additional research including larger numbers of cats is needed to further investigate these findings and explore associations with outcome.

Proposed clinical pathway for nonoperative management of high-grade pediatric pancreatic injuries based on a multicenter analysis: A pediatric trauma society collaborative.

PubMed

Naik-Mathuria, Bindi J; Rosenfeld, Eric H; Gosain, Ankush; Burd, Randall; Falcone, Richard A; Thakkar, Rajan; Gaines, Barbara; Mooney, David; Escobar, Mauricio; Jafri, Mubeen; Stallion, Anthony; Klinkner, Denise B; Russell, Robert; Campbell, Brendan; Burke, Rita V; Upperman, Jeffrey; Juang, David; St Peter, Shawn; Fenton, Stephon J; Beaudin, Marianne; Wills, Hale; Vogel, Adam; Polites, Stephanie; Pattyn, Adam; Leeper, Christine; Veras, Laura V; Maizlin, Ilan; Thaker, Shefali; Smith, Alexis; Waddell, Megan; Drews, Joseph; Gilmore, James; Armstrong, Lindsey; Sandler, Alexis; Moody, Suzanne; Behrens, Brandon; Carmant, Laurence

2017-10-01

Guidelines for nonoperative management (NOM) of high-grade pancreatic injuries in children have not been established, and wide practice variability exists. The purpose of this study was to evaluate common clinical strategies across multiple pediatric trauma centers to develop a consensus-based standard clinical pathway. A multicenter, retrospective review was conducted of children with high-grade (American Association of Surgeons for Trauma grade III-V) pancreatic injuries treated with NOM between 2010 and 2015. Data were collected on demographics, clinical management, and outcomes. Eighty-six patients were treated at 20 pediatric trauma centers. Median age was 9 years (range, 1-18 years). The majority (73%) of injuries were American Association of Surgeons for Trauma grade III, 24% were grade IV, and 3% were grade V. Median time from injury to presentation was 12 hours and median ISS was 16 (range, 4-66). All patients had computed tomography scan and serum pancreatic enzyme levels at presentation, but serial enzyme level monitoring was variable. Pancreatic enzyme levels did not correlate with injury grade or pseudocyst development. Parenteral nutrition was used in 68% and jejunal feeds in 31%. 3Endoscopic retrograde cholangiopancreatogram was obtained in 25%. An organized peripancreatic fluid collection present for at least 7 days after injury was identified in 59% (42 of 71). Initial management of these included: observation 64%, percutaneous drain 24%, and endoscopic drainage 10% and needle aspiration 2%. Clear liquids were started at a median of 6 days (IQR, 3-13 days) and regular diet at a median of 8 days (IQR 4-20 days). Median hospitalization length was 13 days (IQR, 7-24 days). Injury grade did not account for prolonged time to initiating oral diet or hospital length; indicating that the variability in these outcomes was largely due to different surgeon preferences. High-grade pancreatic injuries in children are rare and significant variability exists in NOM strategies, which may affect outcomes and effective resource utilization. A standard clinical pathway is proposed. Therapeutic/care management, level V (case series).

Drawing Nomograms with R: applications to categorical outcome and survival data.

PubMed

Zhang, Zhongheng; Kattan, Michael W

2017-05-01

Outcome prediction is a major task in clinical medicine. The standard approach to this work is to collect a variety of predictors and build a model of appropriate type. The model is a mathematical equation that connects the outcome of interest with the predictors. A new patient with given clinical characteristics can be predicted for outcome with this model. However, the equation describing the relationship between predictors and outcome is often complex and the computation requires software for practical use. There is another method called nomogram which is a graphical calculating device allowing an approximate graphical computation of a mathematical function. In this article, we describe how to draw nomograms for various outcomes with nomogram() function. Binary outcome is fit by logistic regression model and the outcome of interest is the probability of the event of interest. Ordinal outcome variable is also discussed. Survival analysis can be fit with parametric model to fully describe the distributions of survival time. Statistics such as the median survival time, survival probability up to a specific time point are taken as the outcome of interest.

The importance of extreme weight percentile in postoperative morbidity in children.

PubMed

Stey, Anne M; Moss, R Lawrence; Kraemer, Kari; Cohen, Mark E; Ko, Clifford Y; Lee Hall, Bruce

2014-05-01

Anthropometric data are important indicators of child health. This study sought to determine whether anthropometric data of extreme weight were significant predictors of perioperative morbidity in pediatric surgery. This was a cohort study of children 29 days up to 18 years of age undergoing surgical procedures at participating American College of Surgeons' NSQIP Pediatric hospitals in 2011 and 2012. The primary outcomes were composite morbidity and surgical site infection. The primary predictor of interest was weight percentile, which was divided into the following categories: ≤5(th) percentile, 6(th) to 94(th), or ≥95(th) percentile. A hierarchical multivariate logistic model, adjusting for procedure case mix, demographic, and clinical patient characteristic variables, was used to quantify the relationship between weight percentile category and outcomes. Children in the ≤5th weight percentile had 1.19-fold higher odds of overall postoperative morbidity developing than children in the nonextreme range (95% CI, 1.10-1.30) when controlling for clinical variables. Yet these children did not have higher odds of surgical site infection developing. Children in the ≥95(th) weight percentile did not have a significant increase in overall postoperative morbidity. However, they were at 1.35-fold increased odds of surgical site infection compared with those in the nonextreme range when controlling for clinical variables (95% CI, 1.16-1.57). Both extremely high and extremely low weight percentile scores can be associated with increased postoperative complications after controlling for clinical variables. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Clinical audit of COPD patients requiring hospital admissions in Spain: AUDIPOC study.

PubMed

Pozo-Rodríguez, Francisco; López-Campos, Jose Luis; Alvarez-Martínez, Carlos J; Castro-Acosta, Ady; Agüero, Ramón; Hueto, Javier; Hernández-Hernández, Jesús; Barrón, Manuel; Abraira, Victor; Forte, Anabel; Sanchez Nieto, Juan Miguel; Lopez-Gabaldón, Encarnación; Cosío, Borja G; Agustí, Alvar

2012-01-01

AUDIPOC is a nationwide clinical audit that describes the characteristics, interventions and outcomes of patients admitted to Spanish hospitals because of an exacerbation of chronic obstructive pulmonary disease (ECOPD), assessing the compliance of these parameters with current international guidelines. The present study describes hospital resources, hospital factors related to case recruitment variability, patients' characteristics, and adherence to guidelines. An organisational database was completed by all participant hospitals recording resources and organisation. Over an 8-week period 11,564 consecutive ECOPD admissions to 129 Spanish hospitals covering 70% of the Spanish population were prospectively identified. At hospital discharge, 5,178 patients (45% of eligible) were finally included, and thus constituted the audited population. Audited patients were reassessed 90 days after admission for survival and readmission rates. A wide variability was observed in relation to most variables, hospital adherence to guidelines, and readmissions and death. Median inpatient mortality was 5% (across-hospital range 0-35%). Among discharged patients, 37% required readmission (0-62%) and 6.5% died (0-35%). The overall mortality rate was 11.6% (0-50%). Hospital size and complexity and aspects related to hospital COPD awareness were significantly associated with case recruitment. Clinical management most often complied with diagnosis and treatment recommendations but rarely (<50%) addressed guidance on healthy life-styles. The AUDIPOC study highlights the large across-hospital variability in resources and organization of hospitals, patient characteristics, process of care, and outcomes. The study also identifies resources and organizational characteristics associated with the admission of COPD cases, as well as aspects of daily clinical care amenable to improvement.

Controlled assessment of the efficacy of occlusal stabilization splints on sleep bruxism.

PubMed

van der Zaag, Jacques; Lobbezoo, Frank; Wicks, Darrel J; Visscher, Corine M; Hamburger, Hans L; Naeije, Machiel

2005-01-01

To assess the efficacy of occlusal stabilization splints in the management of sleep bruxism (SB) in a double-blind, parallel, controlled, randomized clinical trial. Twenty-one participants were randomly assigned to an occlusal splint group (n = 11; mean age = 34.2 +/- 13.1 years) or a palatal splint (ie, an acrylic palatal coverage) group (n = 10; mean age = 34.9 +/- 11.2 years). Two polysomnographic recordings that included bilateral masseter electromyographic activity were made: one prior to treatment, the other after a treatment period of 4 weeks. The number of bruxism episodes per hour of sleep (Epi/h), the number of bursts per hour (Bur/h), and the bruxism time index (ie, the percentage of total sleep time spent bruxing) were established as outcome variables at a 10% maximum voluntary contraction threshold level. A general linear model was used to test both the effects between splint groups and within the treatment phase as well as their interaction for each outcome variable. Neither occlusal stabilization splints nor palatal splints had an influence on the SB outcome variables or on the sleep variables measured on a group level. In individual cases, variable outcomes were found: Some patients had an increase (33% to 48% of the cases), while others showed no change (33% to 48%) or a decrease (19% to 29%) in SB outcome variables. The absence of significant group effects of splints in the management of SB indicates that caution is required when splints are indicated, apart from their role in the protection against dental wear. The application of splints should therefore be considered at the individual patient level.

Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction.

PubMed

Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G

2017-08-01

Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

Porous titanium construct cup compared to porous coated titanium cup in total hip arthroplasty. A randomised controlled trial.

PubMed

Salemyr, Mats; Muren, Olle; Eisler, Thomas; Bodén, Henrik; Chammout, Ghazi; Stark, André; Sköldenberg, Olof

2015-05-01

The purpose of this study was to determine if a new titanium cup with increased porosity resulted in different periacetabular bone loss and migration compared to a porous coated cup. Fifty-one patients with primary hip osteoarthritis were randomized to either a cup with porous titanium construct backside (porous titanium group, n = 25) or a conventional porous coated titanium cup (control group, n = 26). The primary outcome variable was change in periacetabular bone mineral density two years after surgery measured with dual energy X-ray absorptiometry (DXA). Secondary outcomes were implant fixation measured with radiostereometry (RSA) and clinical outcome scores. The pattern of bone remodelling was similar in the two groups with almost complete restoration to baseline values. BMD diminished in the two proximal zones and increased in the two distal zones. After minimal migration up to six months all implants in both groups became stable. We found no difference between the two groups in clinical outcome scores. In this prospective, randomized, controlled trial on a new porous titanium cup we found, compared to the control group, no clinically relevant differences regarding periacetabular bone preservation, implant fixation or clinical outcome up to two years postoperatively.

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

PubMed

Acri, Mary; Hamovitch, Emily; Mini, Maria; Garay, Elene; Connolly, Claire; McKay, Mary

2017-12-04

Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

Weak ventral striatal responses to monetary outcomes predict an unwillingness to resist cigarette smoking.

PubMed

Wilson, Stephen J; Delgado, Mauricio R; McKee, Sherry A; Grigson, Patricia S; MacLean, R Ross; Nichols, Travis T; Henry, Shannon L

2014-12-01

As a group, cigarette smokers exhibit blunted subjective, behavioral, and neurobiological responses to nondrug incentives and rewards, relative to nonsmokers. Findings from recent studies suggest, however, that there are large individual differences in the devaluation of nondrug rewards among smokers. Moreover, this variability appears to have significant clinical implications, since reduced sensitivity to nondrug rewards is associated with poorer smoking cessation outcomes. Currently, little is known about the neurobiological mechanisms that underlie these individual differences in the responsiveness to nondrug rewards. Here, we tested the hypothesis that individual variability in reward devaluation among smokers is linked to the functioning of the striatum. Specifically, functional magnetic resonance imaging was used to examine variability in the neural response to monetary outcomes in nicotine-deprived smokers anticipating an opportunity to smoke-circumstances found to heighten the devaluation of nondrug rewards by smokers in prior work. We also investigated whether individual differences in reward-related brain activity in those expecting to have access to cigarettes were associated with the degree to which the same individuals subsequently were willing to resist smoking in order to earn additional money. Our key finding was that deprived smokers who exhibited the weakest response to rewards (i.e., monetary gains) in the ventral striatum were least willing to refrain from smoking for monetary reinforcement. These results provide evidence that outcome-related signals in the ventral striatum serve as a marker for clinically meaningful individual differences in reward-motivated behavior among nicotine-deprived smokers.

Profiles of neurological outcome prediction among intensivists.

PubMed

Racine, Eric; Dion, Marie-Josée; Wijman, Christine A C; Illes, Judy; Lansberg, Maarten G

2009-12-01

Advances in intensive care medicine have increased survival rates of patients with critical neurological conditions. The focus of prognostication for such patients is therefore shifting from predicting chances of survival to meaningful neurological recovery. This study assessed the variability in long-term outcome predictions among physicians and aimed to identify factors that may account for this variability. Based on a clinical vignette describing a comatose patient suffering from post-anoxic brain injury intensivists were asked in a semi-structured interview about the patient's specific neurological prognosis and about prognostication in general. Qualitative research methods were used to identify areas of variability in prognostication and to classify physicians according to specific prognostication profiles. Quantitative statistics were used to assess for associations between prognostication profiles and physicians' demographic and practice characteristics. Eighteen intensivists participated. Functional outcome predictions varied along an evaluative dimension (fair/good-poor) and a confidence dimension (certain-uncertain). More experienced physicians tended to be more pessimistic about the patient's functional outcome and more certain of their prognosis. Attitudes toward quality of life varied along an evaluative dimension (good-poor) and a "style" dimension (objective-subjective). Older and more experienced physicians were more likely to express objective judgments of quality of life and to predict a worse quality of life for the patient than their younger and less experienced counterparts. Various prognostication profiles exist among intensivists. These may be dictated by factors such as physicians' age and clinical experience. Awareness of these associations may be a first step to more uniform prognostication.

Predicting Long-Term Global Outcome after Traumatic Brain Injury: Development of a Practical Prognostic Tool Using the Traumatic Brain Injury Model Systems National Database.

PubMed

Walker, William C; Stromberg, Katharine A; Marwitz, Jennifer H; Sima, Adam P; Agyemang, Amma A; Graham, Kristin M; Harrison-Felix, Cynthia; Hoffman, Jeanne M; Brown, Allen W; Kreutzer, Jeffrey S; Merchant, Randall

2018-05-16

For patients surviving serious traumatic brain injury (TBI), families and other stakeholders often desire information on long-term functional prognosis, but accurate and easy-to-use clinical tools are lacking. We aimed to build utilitarian decision trees from commonly collected clinical variables to predict Glasgow Outcome Scale (GOS) functional levels at 1, 2, and 5 years after moderate-to-severe closed TBI. Flexible classification tree statistical modeling was used on prospectively collected data from the TBI-Model Systems (TBIMS) inception cohort study. Enrollments occurred at 17 designated, or previously designated, TBIMS inpatient rehabilitation facilities. Analysis included all participants with nonpenetrating TBI injured between January 1997 and January 2017. Sample sizes were 10,125 (year-1), 8,821 (year-2), and 6,165 (year-5) after cross-sectional exclusions (death, vegetative state, insufficient post-injury time, and unavailable outcome). In our final models, post-traumatic amnesia (PTA) duration consistently dominated branching hierarchy and was the lone injury characteristic significantly contributing to GOS predictability. Lower-order variables that added predictability were age, pre-morbid education, productivity, and occupational category. Generally, patient outcomes improved with shorter PTA, younger age, greater pre-morbid productivity, and higher pre-morbid vocational or educational achievement. Across all prognostic groups, the best and worst good recovery rates were 65.7% and 10.9%, respectively, and the best and worst severe disability rates were 3.9% and 64.1%. Predictability in test data sets ranged from C-statistic of 0.691 (year-1; confidence interval [CI], 0.675, 0.711) to 0.731 (year-2; CI, 0.724, 0.738). In conclusion, we developed a clinically useful tool to provide prognostic information on long-term functional outcomes for adult survivors of moderate and severe closed TBI. Predictive accuracy for GOS level was demonstrated in an independent test sample. Length of PTA, a clinical marker of injury severity, was by far the most critical outcome determinant.

Designing Clinical Trials of Interventions for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) Trial

PubMed Central

Espeland, Mark A.; Gill, Thomas M.; Guralnik, Jack; Miller, Michael E.; Fielding, Roger; Newman, Anne B.; Pahor, Marco

2008-01-01

Background Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Methods Results are described from a pilot clinical trial in which 424 volunteers aged 70–89 years were randomly assigned to one of two interventions -- physical activity or a healthy aging education program -- and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in ≤10 seconds, a physical performance battery, and a questionnaire focused on physical function. Results Changes in all four outcomes were inter-related over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e. appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A four-year trial based on the outcome of 400 meter walk is projected to require N = 962 to 2,234 to detect an intervention effect of 30% to 20% with 90% power. Conclusions Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400 meter walk as their primary outcome. PMID:18000143

Cardiorespiratory interaction with continuous positive airway pressure

PubMed Central

Bonafini, Sara; Fava, Cristiano; Steier, Joerg

2018-01-01

The treatment of choice for obstructive sleep apnoea (OSA) is continuous positive airway pressure therapy (CPAP). Since its introduction in clinical practice, CPAP has been used in various clinical conditions with variable and heterogeneous outcomes. In addition to the well-known effects on the upper airway CPAP impacts on intrathoracic pressures, haemodynamics and blood pressure (BP) control. However, short- and long-term effects of CPAP therapy depend on multiple variables which include symptoms, underlying condition, pressure used, treatment acceptance, compliance and usage. CPAP can alter long-term cardiovascular risk in patients with cardiorespiratory conditions. Furthermore, the effect of CPAP on the awake patient differs from the effect on the patients while asleep, and this might contribute to discomfort and removal of the use interface. The purpose of this review is to highlight the physiological impact of CPAP on the cardiorespiratory system, including short-term benefits and long-term outcomes. PMID:29445529

Clinical and Serological Predictors of Suicide in Schizophrenia and Major Mood Disorders.

PubMed

Dickerson, Faith; Origoni, Andrea; Schweinfurth, Lucy A B; Stallings, Cassie; Savage, Christina L G; Sweeney, Kevin; Katsafanas, Emily; Wilcox, Holly C; Khushalani, Sunil; Yolken, Robert

2018-03-01

Persons with serious mental illness are at high risk for suicide, but this outcome is difficult to predict. Serological markers may help to identify suicide risk. We prospectively assessed 733 persons with a schizophrenia spectrum disorder, 483 with bipolar disorder, and 76 with major depressive disorder for an average of 8.15 years. The initial evaluation consisted of clinical and demographic data as well as a blood samples from which immunoglobulin G antibodies to herpes viruses and Toxoplasma gondii were measured. Suicide was determined using data from the National Death Index. Cox proportional hazard regression models examined the role of baseline variables on suicide outcomes. Suicide was associated with male sex, divorced/separated status, Caucasian race, and elevated levels of antibodies to Cytomegalovirus (CMV). Increasing levels of CMV antibodies were associated with increasing hazard ratios for suicide. The identification of serological variables associated with suicide might provide more personalized methods for suicide prevention.

Personality and the subjective assessment of hearing aids.

PubMed

Cox, R M; Alexander, G C; Gray, G

1999-01-01

Relatively little is known about the influence of patients' personality features on the responses they make to self-assessment items used to measure the outcome of a hearing aid fitting. If the personality of the hearing aid wearer has a significant influence on self-report outcome data, it would be important to explore the relevant personality variables and to be cognizant of their effects when using subjective outcome data to justify decisions about clinical services or other matters. This investigation explored the relationship between several personality attributes and responses to the Abbreviated Profile of Hearing Aid Benefit (APHAB). It found that more extroverted patients tend to report more hearing aid benefit in all speech communication situations. In addition, patients with a more external locus of control tend to have more negative reactions to loud environmental sounds, both with and without amplification. Anxiety also played a small additional role in determining APHAB responses. Although personality variables were found to explain a relatively small amount of the variance in APHAB responses (usually around 10%), these outcomes should alert practitioners and researchers to the potential effects of personality variables in all self-report data.

Generated effect modifiers (GEM's) in randomized clinical trials.

PubMed

Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R Todd

2017-01-01

In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an "effect modifier". Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Clinical research XVII. χ(2) test, from the expected to the observed].

PubMed

Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez, Marcela; Talavera, Juan O

2013-01-01

When you want to show if there is a statistical association or differences between categorical variables, it is recommended to use the χ(2) test. This nonparametric test is one of the most used in clinical research; it contrasts nominal or ordinal qualitative variables that are observed in clinical practice. This test calculates the p value that determines whether differences between groups are real or due to chance. The χ(2) test is the basis of other tests to analyze qualitative ordinal variables as χ(2) for linear trend, which compares three groups with two outcomes or McNemar test, which contrasts two related samples (a before and afterward comparison) or Mantel-Haenszel χ(2), which controls for potential confounding variables. When using small samples, where the expected results are less than 5, Fisher's exact test should be used. These tests are the most widely used in the medical literature; however, they do not give us the magnitude or the direction of the event and a proper interpretation that requires clinical judgment is needed.

Psychosocial functioning in pediatric heart transplant recipients and their families.

PubMed

Cousino, Melissa K; Schumacher, Kurt R; Rea, Kelly E; Eder, Sally; Zamberlan, Mary; Jordan, Jessica; Fredericks, Emily M

2018-03-01

Across pediatric organ transplant populations, patient and family psychosocial functioning is associated with important health-related outcomes. Research has suggested that pediatric heart transplant recipients and their families are at increased risk for adverse psychosocial outcomes; however, recent investigation of psychosocial functioning in this population is lacking. This study aimed to provide a contemporary characterization of psychosocial functioning in pediatric heart transplant recipients and their families. Associations between psychosocial function, demographic variables, and transplant-related variables were investigated. Fifty-six parents/guardians of pediatric heart transplant recipients completed a comprehensive psychosocial screening measure during transplant follow-up clinic visits. Descriptive statistics, correlational analyses, and independent samples t tests were performed. Forty percent of pediatric heart transplant recipients and their families endorsed clinically meaningful levels of total psychosocial risk. One-third of patients presented with clinically significant psychological problems per parent report. Psychosocial risk was unassociated with demographic or transplant-related factors. Despite notable improvements in the survival of pediatric heart transplant recipients over the past decade, patients and families present with sustained psychosocial risks well beyond the immediate post-transplant period, necessitating mental health intervention to mitigate adverse impact on health-related outcomes. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Treatment of gingival recession with coronally advanced flap procedures: a systematic review.

PubMed

Cairo, Francesco; Pagliaro, Umberto; Nieri, Michele

2008-09-01

The treatment of buccal gingival recessions is a common requirement due to aesthetic concern or root sensitivity. The aim of this manuscript was to systematically review the literature on coronally advanced flap (CAF) alone or in combination with tissue grafts, barrier membranes (BM), enamel matrix derivative (EMD) or other material for treating gingival recession. Randomized clinical trials on treatment of Miller Class I and II gingival recessions with at least 6 months of follow-up were identified. Data sources included electronic databases and hand-searched journals. The primary outcome variable was complete root coverage (CRC). The secondary outcome variables were recession reduction, clinical attachment gain, keratinized tissue gain, aesthetic satisfaction, root sensitivity, post-operative patient pain and complications. A total of 794 Miller Class I and II gingival recessions in 530 patients from 25 RCTs were evaluated in this systematic review. CAF was associated with mean recession reduction and CRC. The addition of connective tissue graft (CTG) or EMD enhanced the clinical outcomes of CAF in terms of CRC, while BM did not. The results with respect to the adjunctive use of acellular dermal matrix were controversial. CTG or EMD in conjunction with CAF enhances the probability of obtaining CRC in Miller Class I and II single gingival recessions.

Clinical correlates of enlarged cavum septum pellucidum in schizophrenia: A revisit through computed tomography.

PubMed

Srivastava, Naveen Kumar; Khanra, Sourav; Chail, Vivek; Khess, Christoday R J

2015-06-01

Like prevalence of abnormal cavum septum pellucidum in patients of schizophrenia remains controversial, its role in clinical outcome, duration of illness and effect on treatment remains less understood as well. Our study examined clinical correlates of enlarged cavum septum pellucidum in schizophrenia. A total of 139 patients diagnosed with schizophrenia during the year 2012 and 2013 were taken for the study. We compared them in respect to the presence and absence of enlarged cavum septum pellucidum. We found 16 patients with enlarged cavum septum pellucidum and were compared with those without enlarged cavum septum pellucidum for socio-demographic and clinical variables. We also correlated these clinical variables with dimension of cavum septum pellucidum. We found statistically significant increased current age and duration of illness in patients with enlarged cavum septum pellucidum. The implications of these findings are discussed with possible confounding effect of current age on neuroimaging. No meaningful correlation was found. No difference in clinical variables was found. Retrospective design and use of computed tomography were limitation of our study. Copyright © 2015 Elsevier B.V. All rights reserved.

All-on-4® Treatment Concept for the Rehabilitation of the Completely Edentulous Mandible: A 7-Year Clinical and 5-Year Radiographic Retrospective Case Series with Risk Assessment for Implant Failure and Marginal Bone Level.

PubMed

Maló, Paulo; de Araújo Nobre, Miguel; Lopes, Armando; Ferro, Ana; Gravito, Inês

2015-10-01

Studies are needed to evaluate long-term outcomes of the All-on-4® treatment concept (Nobel Biocare AB) for rehabilitation of edentulous mandibles by assessing marginal bone levels and risk indicators for implant failure. To evaluate 7-year clinical outcomes and 5-year radiographic outcomes of the All-on-4 treatment concept. This retrospective case series included patients admitted for implant rehabilitations in the mandible, who were followed for 7 years clinically and 5 years radiographically. Primary outcome measures were cumulative prosthetic and implant survival using patient as the unit of analysis (Kaplan-Meier product limit estimator). Secondary outcome measure was marginal bone level (MBL) at 5 years. Variables associated with implant failure were analyzed using the Cox proportional hazards regression model to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). Binary logistic regression was used to compute odds ratio (OR) with 95% CIs for variables associated with MBL ≥2.8 mm at 5 years. A total of 324 patients (194 women, 130 men, average age = 58.9 years) were rehabilitated with 1,296 implants supporting 324 full-arch fixed immediately loaded mandibular prostheses. Sixty-four patients (19.8%) were lost to follow-up. Prosthetic survival was 323/324 (99.7%), and 14 patients lost 18 implants, with an estimated cumulative survival rate of 95.4% at 7 years. Variables associated with implant failure were smoking (HR = 5.28; 95% CI: 1.33, 20.91]) and the learning curve effect (0.69 < HR < 0.33 for more experienced levels). Mean MBL at 5 years was 1.81 mm (95% CI: 1.70, 1.92), and smoking was associated with MBL ≥2.8 mm (OR = 2.4; 95% CI: 1.02, 5.62). The high implant and prosthetic survival rates and excellent MBL outcome confirm the predictability and safety of the All-on-4 treatment concept over a longer term than previously reported. © 2014 Wiley Periodicals, Inc.

Implementation and evaluation of a clinical pathway for TRAM breast reconstruction.

PubMed

Hwang, T G; Wilkins, E G; Lowery, J C; Gentile, J

2000-02-01

Among strategies recently proposed to reduce practice variation, promote quality, and control costs in health care delivery, the concept of the clinical pathway has received considerable attention. Because transverse rectus abdominis musculocutaneous (TRAM) breast reconstruction is a common and often costly intervention, this institution sought to evaluate cost and quality outcomes of a clinical pathways program for this procedure. The TRAM reconstruction clinical pathway was implemented in April of 1996 to standardize postoperative care in this patient population. Outcomes of consecutive pathway cases for the first 14 months of the program were assessed in a retrospective cohort design, by using all nonpathway TRAM cases from the 18 months immediately before pathway implementation as controls. Outcomes assessed included length of hospital stay, postoperative complications, total postoperative charges, and total postoperative costs in relative value units. Data on these dependent variables were collected from hospital charts and billing records. The effects of pathway implementation on the outcomes of interest were analyzed by using analysis of covariance to control for potential confounding by other independent variables, including surgical site (unilateral versus bilateral reconstructions), technique (pedicle versus free TRAMs), timing (immediate versus delayed reconstructions), and patient age. Finally, a comparison of variances in the outcomes of interest between the two groups was analyzed by using an Ftest. For all statistical tests, p values of < or = 0.05 were considered significant. Twenty-nine patients were treated in the TRAM pathway group, whereas the control population included 40 nonpathway patients. After implementation of the TRAM pathway, length of stay decreased from 6.0 to 5.2 days; total postoperative charges were reduced from $8587 to $7744; and total postoperative relative value unit utilization declined from 1686 to 1104. Analysis of covariance showed that the decreases in length of hospital stay and relative value units in the TRAM pathway were statistically significant (p = 0.05 and p = 0.007, respectively). By contrast, no significant increase in complications was observed after pathway implementation. Variability in the TRAM pathway group, as measured by SD, decreased significantly for both length of hospital stay (p = 0.039) and relative value units (p = 0.023). Implementation of the TRAM reconstruction clinical pathway resulted in significant declines in length of hospital stay and total costs. These decreases in resource utilization had no significant effect on postoperative complication rates. Although additional research is needed to further assess the impact of clinical pathways, this approach offers considerable promise for improving the cost-effectiveness of health care.

The impact of HIV clinical pharmacists on HIV treatment outcomes: a systematic review

PubMed Central

Saberi, Parya; Dong, Betty J; Johnson, Mallory O; Greenblatt, Ruth M; Cocohoba, Jennifer M

2012-01-01

Objective Due to the rapid proliferation of human immunodeficiency virus (HIV) treatment options, there is a need for health care providers with knowledge of antiretroviral therapy intricacies. In a HIV multidisciplinary care team, the HIV pharmacist is well-equipped to provide this expertise. We conducted a systematic review to assess the impact of HIV pharmacists on HIV clinical outcomes. Methods We searched six electronic databases from January 1, 1980 to June 1, 2011 and included all quantitative studies that examined pharmacist’s roles in the clinical care of HIV-positive adults. Primary outcomes were antiretroviral adherence, viral load, and CD4+ cell count and secondary outcomes included health care utilization parameters, antiretroviral modifications, and other descriptive variables. Results Thirty-two publications were included. Despite methodological limitation, the involvement of HIV pharmacists was associated with statistically significant adherence improvements and positive impact on viral suppression in the majority of studies. Conclusion This systematic review provides evidence of the beneficial impact of HIV pharmacists on HIV treatment outcomes and offers suggestions for future research. PMID:22536064

An assessment of HIV treatment outcomes among utilizers of semi-mobile clinics in rural Kenya.

PubMed

Gorman, Sara E; Martinez, Jose M; Olson, Jennifer

2015-01-01

HIV/AIDS is a major cause of morbidity and mortality in Africa, and rates of retention in treatment are low. Some research has shown that mobile clinics are effective in connecting people in rural areas with health care. We compared HIV outcomes between HIV-positive patients who chose to access treatment from a regional hospital to those who chose care in one of four semi-mobile clinics closer to where they live. The subjects for this analysis were HIV-positive residents in West Pokot accessing care at one of four semi-mobile sites (Kabichbich, Chepareria, Kacheliba, and Sigor) or at the regional hospital in Kapenguria. We examined four outcome variables between the two groups: (1) retention in HIV treatment, (2) change in CD4 count, (3) adherence to ARVs, and (4) deaths. The patients who chose semi-mobile clinic care were less well educated, poorer, and sicker than those who chose to continue care in the regional hospital. There were no statistically significant differences between the groups in any of the four outcome measures. Although the population of patients attending semi-mobile clinics was on average poorer and sicker than those attending the hospital, their outcomes were similar. Care at the semi-mobile clinics did not result in significantly different outcomes from care in the district hospital. This program showed that semi-mobile clinics are a viable alternative to hospital care for very ill, isolated populations, but further measures must be taken to improve retention and adherence in these settings.

Acute viral bronchiolitis: Physician perspectives on definition and clinically important outcomes.

PubMed

Fernandes, Ricardo M; Andrade, Maria Gabriela; Constant, Carolina; Malveiro, Duarte; Magalhães, Manuel; Abreu, Daisy; Azevedo, Inês; Sousa, Eduarda; Salgado, Rizério; Bandeira, Teresa

2016-07-01

Two key limitations hamper intervention research in bronchiolitis: the absence of a clear definition of disease, and the heterogeneous choice of outcome measures in current clinical trials. We assessed how paediatricians and general practitioners (GPs) perceived definition and clinically important outcomes in bronchiolitis. A nationwide online survey (ABBA study) was conducted through the Portuguese Society of Paediatrics and GPs' mailing lists. We assessed agreement with statements on bronchiolitis definition, and participants were asked to score the relative importance of several outcomes. Principal component analysis (PCA) explored dimensions underlying disease definition. Outcomes were ranked by mean score and proportion given highest score. We included 514 paediatricians and 165 GPs (overall 59% were board-certified). Most paediatricians (76.5%) agreed with a definition based on coryza, wheezing and/or crackles/rales, compared to 38.1% GPs (P < 0.001). Less than 5% physicians agreed with a definition commonly used in clinical trials (<12 months, first episode of wheeze). We retained three dimensions on PCA: one based on coryza, rales/crepitations and no sudden onset; another on number of episodes and age; and a third on wheeze. Dimensions varied by physician specialization and training (P < 0.01). Hospital admission and respiratory distress were top rated outcomes by both groups of physicians. Physician definitions of bronchiolitis have considerable variability and often mismatch those of clinical trials. Rating of important outcomes was consistent. Our results highlight the need for a robust standardized definition of acute bronchiolitis in infants and support the development of a core outcome set for future clinical trials. Pediatr Pulmonol. 2016;51:724-732. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Prostate Active Surveillance Study — EDRN Public Portal

Cancer.gov

Primary Objective: To discover and confirm biomarkers that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables. Secondary Objectives: To determine the proportion of patients on active surveillance who progress based on the above criteria. To determine the clinical predictors of disease progression. To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Evaluation of stratification factors and score-scales in clinical trials of treatment of clinical mastitis in dairy cows.

PubMed

Hektoen, L; Ødegaard, S A; Løken, T; Larsen, S

2004-05-01

There is often a need to reduce sample size in clinical trials due to practical limitations and ethical considerations. Better comparability between treatment groups by use of stratification in the design, and use of continuous outcome variables in the evaluation of treatment results, are two methods that can be used in order to achieve this. In this paper the choice of stratification factors in trials of clinical mastitis in dairy cows is investigated, and two score-scales for evaluation of clinical mastitis are introduced. The outcome in 57 dairy cows suffering from clinical mastitis and included in a clinical trial comparing homeopathic treatment, placebo and a standard antibiotic treatment is investigated. The strata of various stratification factors are compared across treatments to determine which other factors influence outcome. The two score scales, measuring acute and chronic mastitis symptoms, respectively, are evaluated on their ability to differentiate between patients classified from clinical criteria as responders or non-responders to treatment. Differences were found between the strata of the factors severity of mastitis, lactation number, previous mastitis this lactation and bacteriological findings. These factors influence outcome of treatment and appear relevant as stratification factors in mastitis trials. Both score scales differentiated between responders and non-responders to treatment and were found useful for evaluation of mastitis and mastitis treatment.

The relationship of individual characteristics, perceived worksite support and perceived creativity to clinical nurses' innovative outcome.

PubMed

Tsai, Hsiu-Min; Liou, Shwu-Ru; Hsiao, Ya-Chu; Cheng, Ching-Yu

2013-09-01

To understand the relationship of individual characteristics, perceived worksite support and perceived personal creativity to clinical nurses' innovative outcome (receiving the Nursing Innovation Award). Since the idea of applying creativity and innovation to clinical nursing practice and management was first advocated in the Nursing Administration Quarterly in 1982, the topic of nursing innovation has gained worldwide attention. To increase the prevalence of nursing innovation, it is important to identify and understand the related factors that influence nurses' innovative outcome. This study used a cross-sectional descriptive survey design. A self-administered questionnaire was completed by 32 award winners and 506 nonawarded clinical nurses in Taiwan. The level of creativity perceived by all participants was moderate-to-high. Individual characteristics (r = 0·61) and worksite support (r = 0·27) were both correlated with perceived creativity. Individual characteristics and worksite support showed some correlation as well (r = 0·21). Individual characteristics and worksite support could predict perceived creativity after controlling for demographic variables, but only individual characteristics had an effect on innovative outcome. Perceived creativity did not have mediation effects either between individual characteristics and innovative outcome or between worksite support and innovative outcome. Clinical nurses' individual characteristics had a direct relationship to innovative outcome, whereas neither worksite support nor creativity was correlated with innovative outcome. Although worksite support did not show effects on innovative outcome, it was related to both perceived creativity and individual characteristics. As suggested by other scholars, there might be other related factors between creativity and innovative outcome. Although worksite support did not have effect on clinical nurses' innovative outcome, it was related to individual characteristics. Hospital administrators or nursing directors can foster a supportive environment where creative nurses would be more likely to work and engage in innovative activities. © 2013 John Wiley & Sons Ltd.

The Computer Book of the Internal Medicine Resident: competence acquisition and achievement of learning objectives.

PubMed

Oristrell, J; Oliva, J C; Casanovas, A; Comet, R; Jordana, R; Navarro, M

2014-01-01

The Computer Book of the Internal Medicine resident (CBIMR) is a computer program that was validated to analyze the acquisition of competences in teams of Internal Medicine residents. To analyze the characteristics of the rotations during the Internal Medicine residency and to identify the variables associated with the acquisition of clinical and communication skills, the achievement of learning objectives and resident satisfaction. All residents of our service (n=20) participated in the study during a period of 40 months. The CBIMR consisted of 22 self-assessment questionnaires specific for each rotation, with items on services (clinical workload, disease protocolization, resident responsibilities, learning environment, service organization and teamwork) and items on educational outcomes (acquisition of clinical and communication skills, achievement of learning objectives, overall satisfaction). Associations between services features and learning outcomes were analyzed using bivariate and multivariate analysis. An intense clinical workload, high resident responsibilities and disease protocolization were associated with the acquisition of clinical skills. High clinical competence and teamwork were both associated with better communication skills. Finally, an adequate learning environment was associated with increased clinical competence, the achievement of educational goals and resident satisfaction. Potentially modifiable variables related with the operation of clinical services had a significant impact on the acquisition of clinical and communication skills, the achievement of educational goals, and resident satisfaction during the specialized training in Internal Medicine. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Testing Components of a Self-Management Theory in Adolescents With Type 1 Diabetes Mellitus.

PubMed

Verchota, Gwen; Sawin, Kathleen J

The role of self-management in adolescents with type 1 diabetes mellitus is not well understood. The purpose of the research was to examine the relationship of key individual and family self-management theory, context, and process variables on proximal (self-management behaviors) and distal (hemoglobin A1c and diabetes-specific health-related quality of life) outcomes in adolescents with type 1 diabetes. A correlational, cross-sectional study was conducted to identify factors contributing to outcomes in adolescents with Type 1 diabetes and examine potential relationships between context, process, and outcome variables delineated in individual and family self-management theory. Participants were 103 adolescent-parent dyads (adolescents ages 12-17) with Type 1 diabetes from a Midwest, outpatient, diabetes clinic. The dyads completed a self-report survey including instruments intended to measure context, process, and outcome variables from individual and family self-management theory. Using hierarchical multiple regression, context (depressive symptoms) and process (communication) variables explained 37% of the variance in self-management behaviors. Regimen complexity-the only significant predictor-explained 11% of the variance in hemoglobin A1c. Neither process variables nor self-management behaviors were significant. For the diabetes-specific health-related quality of life outcome, context (regimen complexity and depressive symptoms) explained 26% of the variance at step 1; an additional 9% of the variance was explained when process (self-efficacy and communication) variables were added at step 2; and 52% of the variance was explained when self-management behaviors were added at Step 3. In the final model, three variables were significant predictors: depressive symptoms, self-efficacy, and self-management behaviors. The individual and family self-management theory can serve as a cogent theory for understanding key concepts, processes, and outcomes essential to self-management in adolescents and families dealing with Type 1 diabetes mellitus.

Impact of margin status and lymphadenectomy on clinical outcomes in resected pancreatic adenocarcinoma: implications for adjuvant radiotherapy.

PubMed

Osipov, Arsen; Naziri, Jason; Hendifar, Andrew; Dhall, Deepti; Rutgers, Joanne K; Chopra, Shefali; Li, Quanlin; Tighiouart, Mourad; Annamalai, Alagappan; Nissen, Nicholas N; Tuli, Richard

2016-04-01

Adjuvant chemoradiotherapy (CRT) in the treatment of pancreatic ductal adenocarcinoma (PDA) is controversial. Minimal data exists regarding the clinical significance of margin clearance distance and lymph node (LN) parameters, such as extent of dissection and LN ratio. We assessed the impact of these variables on clinical outcomes to more clearly define the subset of patients who may benefit from adjuvant radiotherapy (RT). We identified 106 patients with resected stage 1-3 PDA from 2007-2013. Resection margins were categorized as positive (tumor at ink), ≤1, or >1 mm. LN evaluation included total number examined (NE), number of positive nodes (NP), ratio of NP to NE (NR), extent of dissection, and positive periportal LNs. The impact of these variables was assessed on disease-free survival (DFS) and overall survival (OS) using multivariate cox proportional hazards modeling. In patients receiving adjuvant chemotherapy (CT) alone, greater margin clearance led to improved DFS (P=0.0412, HR =0.51). Range of NE was 4-37, with a mean of 19. NE was not associated with DFS or OS, yet absolute NP of 5 or more was associated with a significantly worse DFS (P=0.005). Whereas periportal lymphadenectomy did not result in improved DFS or OS, patients with positive periportal LN had worse clinical outcomes (DFS, P=0.0052; OS, P=0.023). The use of adjuvant CRT was associated with improved OS (P=0.049; HR=0.29). In patients receiving adjuvant CT alone, there was a clinically significant benefit to clearing the surgical margin beyond tumor at ink. Having ≥5 NP and positive periportal LN led to significantly worse clinical outcomes. The addition of adjuvant RT to CT in resected PDA improved OS. A comprehensive evaluation of resection margin distance and LN parameters may identify more patients at risk for locoregional failure who may benefit from adjuvant CRT.

Impact of margin status and lymphadenectomy on clinical outcomes in resected pancreatic adenocarcinoma: implications for adjuvant radiotherapy

PubMed Central

Osipov, Arsen; Naziri, Jason; Hendifar, Andrew; Dhall, Deepti; Rutgers, Joanne K.; Chopra, Shefali; Li, Quanlin; Tighiouart, Mourad; Annamalai, Alagappan; Nissen, Nicholas N.

2016-01-01

Background Adjuvant chemoradiotherapy (CRT) in the treatment of pancreatic ductal adenocarcinoma (PDA) is controversial. Minimal data exists regarding the clinical significance of margin clearance distance and lymph node (LN) parameters, such as extent of dissection and LN ratio. We assessed the impact of these variables on clinical outcomes to more clearly define the subset of patients who may benefit from adjuvant radiotherapy (RT). Methods We identified 106 patients with resected stage 1-3 PDA from 2007-2013. Resection margins were categorized as positive (tumor at ink), ≤1, or >1 mm. LN evaluation included total number examined (NE), number of positive nodes (NP), ratio of NP to NE (NR), extent of dissection, and positive periportal LNs. The impact of these variables was assessed on disease-free survival (DFS) and overall survival (OS) using multivariate cox proportional hazards modeling. Results In patients receiving adjuvant chemotherapy (CT) alone, greater margin clearance led to improved DFS (P=0.0412, HR =0.51). Range of NE was 4-37, with a mean of 19. NE was not associated with DFS or OS, yet absolute NP of 5 or more was associated with a significantly worse DFS (P=0.005). Whereas periportal lymphadenectomy did not result in improved DFS or OS, patients with positive periportal LN had worse clinical outcomes (DFS, P=0.0052; OS, P=0.023). The use of adjuvant CRT was associated with improved OS (P=0.049; HR=0.29). Conclusions In patients receiving adjuvant CT alone, there was a clinically significant benefit to clearing the surgical margin beyond tumor at ink. Having ≥5 NP and positive periportal LN led to significantly worse clinical outcomes. The addition of adjuvant RT to CT in resected PDA improved OS. A comprehensive evaluation of resection margin distance and LN parameters may identify more patients at risk for locoregional failure who may benefit from adjuvant CRT. PMID:27034792

Can We Predict Functional Outcome in Neonates with Hypoxic Ischemic Encephalopathy by the Combination of Neuroimaging and Electroencephalography?

PubMed Central

Nanavati, Tania; Seemaladinne, Nirupama; Regier, Michael; Yossuck, Panitan; Pergami, Paola

2015-01-01

Background Neonatal hypoxic ischemic encephalopathy (HIE) is a major cause of mortality, morbidity, and long-term neurological deficits. Despite the availability of neuroimaging and neurophysiological testing, tools for accurate early diagnosis and prediction of developmental outcome are still lacking. The goal of this study was to determine if combined use of magnetic resonance imaging (MRI) and electroencephalography (EEG) findings could support outcome prediction. Methods We retrospectively reviewed records of 17 HIE neonates, classified brain MRI and EEG findings based on severity, and assessed clinical outcome up to 48 months. We determined the relation between MRI/EEG findings and clinical outcome. Results We demonstrated a significant relationship between MRI findings and clinical outcome (Fisher’s exact test, p = 0.017). EEG provided no additional information about the outcome beyond that contained in the MRI score. The statistical model for outcome prediction based on random forests suggested that EEG readings at 24 hours and 72 hours could be important variables for outcome prediction, but this needs to be investigated further. Conclusion Caution should be used when discussing prognosis for neonates with mild-to-moderate HIE based on early MR imaging and EEG findings. A robust, quantitative marker of HIE severity that allows for accurate prediction of long-term outcome, particularly for mild-to-moderate cases, is still needed. PMID:25862075

Surrogate Endpoints and Risk Adaptive Strategies in Previously Untreated Follicular Lymphoma.

PubMed

Narkhede, Mayur S; Cheson, Bruce D

2018-05-05

Follicular lymphoma is the second most common subtype of non-Hodgkin lymphoma with an estimated 3.18 cases per 100,000 people. Despite the prolongation of survival with chemoimmunotherapy, variability in response to initial treatment and outcome still exists. Whereas prolonging overall survival is important, it is generally an unreasonable primary endpoint in the front-line setting. The long follow-up needed and the influence of subsequent therapies creates a potential bias. Thus, clinical trials require approximately 5 to 8 years from activation to completion and analysis of outcomes. This duration results in enormous cost and a delay in developing newer therapies. Thus, there is a need to identify markers or surrogate endpoints that can be used in clinical trials to expedite the development of new treatments. This review will discuss various clinical, radiologic, and laboratory measures used to assess outcomes and overall survival in patients with untreated follicular lymphoma, and gauge their utility in clinical trials as surrogate endpoints. Copyright © 2018 Elsevier Inc. All rights reserved.

Development of a Core Clinical Dataset to Characterize Serious Illness, Injuries, and Resource Requirements for Acute Medical Responses to Public Health Emergencies.

PubMed

Murphy, David J; Rubinson, Lewis; Blum, James; Isakov, Alexander; Bhagwanjee, Statish; Cairns, Charles B; Cobb, J Perren; Sevransky, Jonathan E

2015-11-01

In developed countries, public health systems have become adept at rapidly identifying the etiology and impact of public health emergencies. However, within the time course of clinical responses, shortfalls in readily analyzable patient-level data limit capabilities to understand clinical course, predict outcomes, ensure resource availability, and evaluate the effectiveness of diagnostic and therapeutic strategies for seriously ill and injured patients. To be useful in the timeline of a public health emergency, multi-institutional clinical investigation systems must be in place to rapidly collect, analyze, and disseminate detailed clinical information regarding patients across prehospital, emergency department, and acute care hospital settings, including ICUs. As an initial step to near real-time clinical learning during public health emergencies, we sought to develop an "all-hazards" core dataset to characterize serious illness and injuries and the resource requirements for acute medical response across the care continuum. A multidisciplinary panel of clinicians, public health professionals, and researchers with expertise in public health emergencies. Group consensus process. The consensus process included regularly scheduled conference calls, electronic communications, and an in-person meeting to generate candidate variables. Candidate variables were then reviewed by the group to meet the competing criteria of utility and feasibility resulting in the core dataset. The 40-member panel generated 215 candidate variables for potential dataset inclusion. The final dataset includes 140 patient-level variables in the domains of demographics and anthropometrics (7), prehospital (11), emergency department (13), diagnosis (8), severity of illness (54), medications and interventions (38), and outcomes (9). The resulting all-hazard core dataset for seriously ill and injured persons provides a foundation to facilitate rapid collection, analyses, and dissemination of information necessary for clinicians, public health officials, and policymakers to optimize public health emergency response. Further work is needed to validate the effectiveness of the dataset in a variety of emergency settings.

Patient-Reported Outcomes of Periacetabular Osteotomy from the Prospective ANCHOR Cohort Study

PubMed Central

Clohisy, John C.; Ackerman, Jeffrey; Baca, Geneva; Baty, Jack; Beaulé, Paul E.; Kim, Young-Jo; Millis, Michael B.; Podeszwa, David A.; Schoenecker, Perry L.; Sierra, Rafael J.; Sink, Ernest L.; Sucato, Daniel J.; Trousdale, Robert T.; Zaltz, Ira

2017-01-01

Background: Current literature describing the periacetabular osteotomy (PAO) is mostly limited to retrospective case series. Larger, prospective cohort studies are needed to provide better clinical evidence regarding this procedure. The goals of the current study were to (1) report minimum 2-year patient-reported outcomes (pain, hip function, activity, overall health, and quality of life), (2) investigate preoperative clinical and disease characteristics as predictors of clinical outcomes, and (3) report the rate of early failures and reoperations in patients undergoing contemporary PAO surgery. Methods: A large, prospective, multicenter cohort of PAO procedures was established, and outcomes at a minimum of 2 years were analyzed. A total of 391 hips were included for analysis (79% of the patients were female, and the average patient age was 25.4 years). Patient-reported outcomes, conversion to total hip replacement, reoperations, and major complications were documented. Variables with a p value of ≤0.10 in the univariate linear regressions were included in the multivariate linear regression. The backward stepwise selection method was used to determine the final risk factors of clinical outcomes. Results: Clinical outcome analysis demonstrated major clinically important improvements in pain, function, quality of life, overall health, and activity level. Increasing age and a body mass index status of overweight or obese were predictive of improved results for certain outcome metrics. Male sex and mild acetabular dysplasia were predictive of lesser improvements in certain outcome measures. Three (0.8%) of the hips underwent early conversion to total hip arthroplasty, 12 (3%) required reoperation, and 26 (7%) experienced a major complication. Conclusions: This large, prospective cohort study demonstrated the clinical success of contemporary PAO surgery for the treatment of symptomatic acetabular dysplasia. Patient and disease characteristics demonstrated predictive value that should be considered in surgical decision-making. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. PMID:28060231

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.

Therapeutic effectiveness of Ageratina pichinchensis on the treatment of chronic interdigital tinea pedis: a randomized, double-blind clinical trial.

PubMed

Romero-Cerecero, Ofelia; Zamilpa, Alejandro; Jiménez-Ferrer, Enrique; Tortoriello, Jaime

2012-06-01

Interdigital tinea pedis is the most frequent presentation, as well as the most severe clinical form of tinea pedis, constituting a therapeutic challenge. The aim of the study was to evaluate the effectiveness and tolerability of two concentrations of Ageratina pichinchensis extract (encecalin content, 0.76 and 1.52%, respectively) on patients with clinical and mycological diagnosis of chronic interdigital tinea pedis. By means of a randomized, double-blind clinical trial, three groups of patients were treated topically for 4 weeks with a cream containing the following: Group I-the lower concentration of A. pichinchensis extract, group II-the higher concentration, group III-2% ketoconazole. One hundred and sixty (160) ambulatory patients of either sex between the ages of 18 and 65 years were enrolled. The primary outcome variables were: clinical effectiveness, mycological effectiveness, therapeutic cure, tolerability, and treatment compliance. The secondary outcome variable was therapeutic success. At the end of treatment, therapeutic cure was achieved by 34.1, 41.8, and 39.53% of Groups I, II, and III, respectively. No statistical difference between the groups was observed. Both treatments were effective for the treatment of interdigital-type tinea pedis, while better results were observed on patients that received the higher concentration of the extract.

A novel rapid access testicular cancer clinic: prospective evaluation after one year.

PubMed

Carey, K; Davis, N F; Elamin, S; Ahern, P; Brady, C M; Sweeney, P

2016-02-01

Our institution has recently developed a rapid access outpatient clinic to investigate men with testicular lumps and/or pain suspicious for testicular cancer (TCa). To present our experience after 12 months. All referrals to the rapid access testicular clinic (RATC) clinic were prospectively analysed from 01/01/2013 to 01/01/2014. The primary outcome variable was incidence of TCa in the referred patient cohort. Secondary outcome variables were waiting times prior to clinical review and waiting times prior to radical orchidectomy in patients diagnosed with TCa. Seventy-four new patients were referred to the RATC during the 1-year period and the mean age was 34 (range 15-81 years). TCa was the most common diagnosis and was found in 18 (25 %) patients. Patients diagnosed with TCa underwent radical orchidectomy, a median of 3 (range 1-5) days after their initial GP referral. Patients requiring surgical intervention for benign scrotal pathology underwent their procedure a median of 32 (range 3-61) days after their initial referral. Of the 18 patients diagnosed with TCa, 9 (50 %) were diagnosed with a seminomatous germ cell tumour on histopathology. The RATC is a new initiative in Ireland that provides expedient and definitive treatment of patients with newly diagnosed TCa. Early treatment will ultimately improve long-term prognosis in this patient cohort.

Predictors of Outcome in Traumatic Brain Injury: New Insight Using Receiver Operating Curve Indices and Bayesian Network Analysis.

PubMed

Zador, Zsolt; Sperrin, Matthew; King, Andrew T

2016-01-01

Traumatic brain injury remains a global health problem. Understanding the relative importance of outcome predictors helps optimize our treatment strategies by informing assessment protocols, clinical decisions and trial designs. In this study we establish importance ranking for outcome predictors based on receiver operating indices to identify key predictors of outcome and create simple predictive models. We then explore the associations between key outcome predictors using Bayesian networks to gain further insight into predictor importance. We analyzed the corticosteroid randomization after significant head injury (CRASH) trial database of 10008 patients and included patients for whom demographics, injury characteristics, computer tomography (CT) findings and Glasgow Outcome Scale (GCS) were recorded (total of 13 predictors, which would be available to clinicians within a few hours following the injury in 6945 patients). Predictions of clinical outcome (death or severe disability at 6 months) were performed using logistic regression models with 5-fold cross validation. Predictive performance was measured using standardized partial area (pAUC) under the receiver operating curve (ROC) and we used Delong test for comparisons. Variable importance ranking was based on pAUC targeted at specificity (pAUCSP) and sensitivity (pAUCSE) intervals of 90-100%. Probabilistic associations were depicted using Bayesian networks. Complete AUC analysis showed very good predictive power (AUC = 0.8237, 95% CI: 0.8138-0.8336) for the complete model. Specificity focused importance ranking highlighted age, pupillary, motor responses, obliteration of basal cisterns/3rd ventricle and midline shift. Interestingly when targeting model sensitivity, the highest-ranking variables were age, severe extracranial injury, verbal response, hematoma on CT and motor response. Simplified models, which included only these key predictors, had similar performance (pAUCSP = 0.6523, 95% CI: 0.6402-0.6641 and pAUCSE = 0.6332, 95% CI: 0.62-0.6477) compared to the complete models (pAUCSP = 0.6664, 95% CI: 0.6543-0.679, pAUCSE = 0.6436, 95% CI: 0.6289-0.6585, de Long p value 0.1165 and 0.3448 respectively). Bayesian networks showed the predictors that did not feature in the simplified models were associated with those that did. We demonstrate that importance based variable selection allows simplified predictive models to be created while maintaining prediction accuracy. Variable selection targeting specificity confirmed key components of clinical assessment in TBI whereas sensitivity based ranking suggested extracranial injury as one of the important predictors. These results help refine our approach to head injury assessment, decision-making and outcome prediction targeted at model sensitivity and specificity. Bayesian networks proved to be a comprehensive tool for depicting probabilistic associations for key predictors giving insight into why the simplified model has maintained accuracy.

Baseline Predictors for Success Following Strategy-Based Cognitive Remediation Group Training in Schizophrenia.

PubMed

Farreny, Aida; Aguado, Jaume; Corbera, Silvia; Ochoa, Susana; Huerta-Ramos, Elena; Usall, Judith

2016-08-01

Our aim was to examine predictive variables associated with the improvement in cognitive, clinical, and functional outcomes after outpatient participation in REPYFLEC strategy-based Cognitive Remediation (CR) group training. In addition, we investigated which factors might be associated with some long-lasting effects at 6 months' follow-up. Predictors of improvement after CR were studied in a sample of 29 outpatients with schizophrenia. Partial correlations were computed between targeted variables and outcomes of response to explore significant associations. Subsequently, we built linear regression models for each outcome variable and predictors of improvement. The improvement in negative symptoms at posttreatment was linked to faster performance in the Trail Making Test B. Disorganization and cognitive symptoms were related to changes in executive function at follow-up. Lower levels of positive symptoms were related to durable improvements in life skills. Levels of symptoms and cognition were associated with improvements following CR, but the pattern of resulting associations was nonspecific.

Monitoring of Intracranial Pressure in Meningitis.

PubMed

Depreitere, Bart; Bruyninckx, Dominike; Güiza, Fabian

2016-01-01

The literature on intracranial pressure (ICP) monitoring in meningitis is limited to case reports and a handful of descriptive series. The aim of this study is to investigate relationships among ICP, cerebral perfusion pressure (CPP), and outcome in meningitis and to identify whether ICP affected clinical decisions. Between 1999 and 2011, a total of 17 patients with meningitis underwent ICP monitoring at the University Hospitals Leuven. Charts were reviewed for clinical history, ICP/CPP data, imaging findings, and Glasgow Outcome Scale score. Univariate correlations were computed for outcome and ICP/CPP variables, computed tomography characteristics, and Corticosteroid Randomization After Significant Head Injury outcome model variables. Treatment decisions were assessed regarding whether or not they were based on ICP. At drain placement, Glasgow Coma Scale scores showed a median of 8 (range 3-12). Six of 17 patients had either one or two nonreactive pupils. Significant correlations with outcome were found for the highest documented ICP value (r = -0.70), the number of episodes when CPP <50 mmHg (r =-0.50), the lowest documented CPP value (r = 0.61), and pupil reactivity (r = 0.57). Treatment was influenced by ICP in all patients. The results support the notion that in meningitis high ICP and low CPP represent secondary insults. The poor condition of the patients illustrates that the level of suspicion for increased ICP in meningitis may not be high enough.

An RCT Evaluating the Effects of Skills Training and Medication Type on Work Outcomes Among Patients With Schizophrenia.

PubMed

Glynn, Shirley M; Marder, Stephen R; Noordsy, Douglas L; O'Keefe, Christopher; Becker, Deborah R; Drake, Robert E; Sugar, Catherine A

2017-03-01

Although supported employment increases job acquisition for people with serious mental illness, data on participants' job tenure have been variable. This study evaluated the effects of a standardized work skills training program (the Workplace Fundamentals Module [WPFM]) on job tenure and other work outcomes among individuals receiving individual placement and support (IPS). The effects of two atypical antipsychotic medications on side effects were also tested. The primary hypothesis tested was that participants in IPS plus WPFM would have increased job tenure compared with those enrolled in IPS only, and the secondary hypothesis was that different antipsychotic medications would yield unique side effects. A 2×2 randomized controlled trial compared work outcomes, including job tenure, of participants receiving IPS with or without WPFM for up to two years after obtaining a job. Participants were also randomly assigned to olanzapine or risperidone. Measures of work outcomes, clinical status, and medication side effects were collected. Among 107 participants, 63% obtained at least one job. WPFM did not increase job tenure (51.53 and 41.37 total weeks worked for IPS only and IPS plus WPFM, respectively) or affect other work outcomes. Participants on olanzapine experienced increased body mass index, whereas those on risperidone lost weight, but medications did not differentially affect clinical or job outcomes. Clinic-based skills training did not improve work outcomes accruing from IPS. Risperidone, compared with olanzapine, may reduce body mass but has no differential effect on other work or clinical outcomes.

Motivational and neurocognitive deficits are central to the prediction of longitudinal functional outcome in schizophrenia.

PubMed

Fervaha, G; Foussias, G; Agid, O; Remington, G

2014-10-01

Functional impairment is characteristic of most individuals with schizophrenia; however, the key variables that undermine community functioning are not well understood. This study evaluated the association between selected clinical variables and one-year longitudinal functional outcomes in patients with schizophrenia. The sample included 754 patients with schizophrenia who completed both baseline and one-year follow-up visits in the CATIE study. Patients were evaluated with a comprehensive battery of assessments capturing symptom severity and cognitive performance among other variables. The primary outcome variable was functional status one-year postbaseline measured using the Heinrichs-Carpenter Quality of Life Scale. Factor analysis of negative symptom items revealed two factors reflecting diminished expression and amotivation. Multivariate regression modeling revealed several significant independent predictors of longitudinal functioning scores. The strongest predictors were baseline amotivation and neurocognition. Both amotivation and neurocognition also had independent predictive value for each of the domains of functioning assessed (e.g., vocational). Both motivational and neurocognitive deficits independently contribute to longitudinal functional outcomes assessed 1 year later among patients with schizophrenia. Both of these domains of psychopathology impede functional recovery; hence, it follows that treatments ameliorating each of these symptoms should promote community functioning among individuals with schizophrenia. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Physician control of needle and syringe during aspiration-injection procedures with the new reciprocating syringe.

PubMed

Sibbitt, Wilmer; Sibbitt, Randy R; Michael, Adrian A; Fu, Druce I; Draeger, Hilda T; Twining, Jon M; Bankhurst, Arthur D

2006-04-01

To evaluate physician control of needle and syringe during aspiration-injection syringe procedures by comparing the new reciprocating procedure syringe to a traditional conventional syringe. Twenty-six physicians were tested for their individual ability to control the reciprocating and conventional syringes in typical aspiration-injection procedures using a novel quantitative needle-based displacement procedure model. Subsequently, the physicians performed 48 clinical aspiration-injection (arthrocentesis) procedures on 32 subjects randomized to the reciprocating or conventional syringes. Clinical outcomes included procedure time, patient pain, and operator satisfaction. Multivariate modeling methods were used to determine the experimental variables in the syringe control model most predictive of clinical outcome measures. In the model system, the reciprocating syringe significantly improved physician control of the syringe and needle, with a 66% reduction in unintended forward penetration (p < 0.001) and a 68% reduction in unintended retraction (p < 0.001). In clinical arthrocentesis, improvements were also noted: 30% reduction in procedure time (p < 0.03), 57% reduction in patient pain (p < 0.001), and a 79% increase in physician satisfaction (p < 0.001). The variables in the experimental system--unintended forward penetration, unintended retraction, and operator satisfaction--independently predicted the outcomes of procedure time, patient pain, and physician satisfaction in the clinical study (p < or = 0.001). The reciprocating syringe reduces procedure time and patient pain and improves operator satisfaction with the procedure syringe. The reciprocating syringe improves physician performance in both the validated quantitative needle-based displacement model and in real aspiration-injection syringe procedures, including arthrocentesis.

Validated surrogate endpoints needed for peri-implantitis.

PubMed

Lee, Dong Won

2011-01-01

Pubmed, Cochrane and Lilac databases, Google, Google Scholar, hand searching of websites of major dental journals. The reference list of five recently published systematic reviews on peri-implantitis treatment were also screened for potential studies. Randomised controlled trials and non-randomised studies in English, German, French, Spanish and Italian on peri-implantitis treatment in humans were included. Case series, case reports and cross sectional or non-therapy studies were excluded from the assessment of endpoints. No minimum follow up time was set for studies that were included. Data were extracted in duplicate by two reviewers and disagreements were resolved by consensus. True endpoints for peri-implantitis treatment were considered only if they provided evidence of tangible benefit to the patient. The outcome variables regarded as true endpoints were implant failure, aesthetic assessment and variables related to quality of life, but these were only considered if they were clearly identified as an objective of the research, not as an outcome of treatment. Surrogate endpoints were considered as those measurements of clinical outcomes such as probing pocket depth and clinical attachment level. Fourteen studies were included in this review with data on implant failure presented solely as consequence of peri-implantitis therapy. No true endpoint was described for any study on peri-implantitis. Mean pocket probing depth, clinical attachment level and bleeding on probing were the three surrogate endpoints cited most often in the literature. All endpoints used in the trials reviewed are surrogates of clinical events, such as implant failure. Clinical surrogate endpoints should be validated to assess the real effect of these measures on true endpoints.

Improving the prognosis of patients with severely decreased glomerular filtration rate (CKD G4+): conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference

PubMed Central

Eckardt, Kai-Uwe; Bansal, Nisha; Coresh, Josef; Evans, Marie; Grams, Morgan E.; Herzog, Charles A.; James, Matthew T.; Heerspink, Hiddo J.L.; Pollock, Carol A.; Stevens, Paul E.; Tamura, Manjula Kurella; Tonelli, Marcello A.; Wheeler, David C.; Winkelmayer, Wolfgang C.; Cheung, Michael; Hemmelgarn, Brenda R.

2018-01-01

Patients with severely decreased glomerular filtration rate (GFR) (i.e., chronic kidney disease [CKD] G4+) are at increased risk for kidney failure, cardiovascular disease (CVD) events (including heart failure), and death. However, little is known about the variability of outcomes and optimal therapeutic strategies, including initiation of kidney replacement therapy (KRT). Kidney Disease: Improving Global Outcomes (KDIGO) organized a Controversies Conference with an international expert group in December 2016 to address this gap in knowledge. In collaboration with the CKD Prognosis Consortium (CKD-PC) a global meta-analysis of cohort studies (n = 264,515 individuals with CKD G4+) was conducted to better understand the timing of clinical outcomes in patients with CKD G4+ and risk factors for different outcomes. The results confirmed the prognostic value of traditional CVD risk factors in individuals with severely decreased GFR, although the risk estimates vary for kidney and CVD outcomes. A 2- and 4-year model of the probability and timing of kidney failure requiring KRT was also developed. The implications of these findings for patient management were discussed in the context of published evidence under 4 key themes: management of CKD G4+, diagnostic and therapeutic challenges of heart failure, shared decision-making, and optimization of clinical trials in CKD G4+ patients. Participants concluded that variable prognosis of patients with advanced CKD mandates individualized, risk-based management, factoring in competing risks and patient preferences. PMID:29656903

Assessment of general movements and heart rate variability in prediction of neurodevelopmental outcome in preterm infants.

PubMed

Dimitrijević, Lidija; Bjelaković, Bojko; Čolović, Hristina; Mikov, Aleksandra; Živković, Vesna; Kocić, Mirjana; Lukić, Stevo

2016-08-01

Adverse neurologic outcome in preterm infants could be associated with abnormal heart rate (HR) characteristics as well as with abnormal general movements (GMs) in the 1st month of life. To demonstrate to what extent GMs assessment can predict neurological outcome in preterm infants in our clinical setting; and to assess the clinical usefulness of time-domain indices of heart rate variability (HRV) in improving predictive value of poor repertoire (PR) GMs in writhing period. Qualitative assessment of GMs at 1 and 3 months corrected age; 24h electrocardiography (ECG) recordings and analyzing HRV at 1 month corrected age. Seventy nine premature infants at risk of neurodevelopmental impairments were included prospectively. Neurodevelopmental outcome was assessed at the age of 2 years corrected. Children were classified as having normal neurodevelopmental status, minor neurologic dysfunction (MND), or cerebral palsy (CP). We found that GMs in writhing period (1 month corrected age) predicted CP at 2 years with sensitivity of 100%, and specificity of 72.1%. Our results demonstrated the excellent predictive value of cramped synchronized (CS) GMs, but not of PR pattern. Analyzing separately a group of infants with PR GMs we found significantly lower values of HRV parameters in infants who later developed CP or MND vs. infants with PR GMs who had normal outcome. The quality of GMs was predictive for neurodevelopmental outcome at 2 years. Prediction of PR GMs was significantly enhanced with analyzing HRV parameters. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Variables associated with health-related quality of life in a Brazilian sample of patients from a tertiary outpatient clinic for depression and anxiety disorders.

PubMed

Schwab, Bianca; Daniel, Heloisa Silveira; Lutkemeyer, Carine; Neves, João Arthur Lange Lins; Zilli, Louise Nassif; Guarnieri, Ricardo; Diaz, Alexandre Paim; Michels, Ana Maria Maykot Prates

2015-01-01

Health-related quality of life (HRQOL) assessment tools have been broadly used in the medical context. These tools are used to measure the subjective impact of the disease on patients. The objective of this study was to evaluate the variables associated with HRQOL in a Brazilian sample of patients followed up in a tertiary outpatient clinic for depression and anxiety disorders. Cross-sectional study. Independent variables were those included in a sociodemographic questionnaire and the Hospital Anxiety and Depression Scale (HADS) scores. Dependent variables were those included in the short version of the World Health Organization Quality of Life (WHOQOL-BREF) and the scores for its subdomains (overall quality of life and general health, physical health, psychological health, social relationships, and environment). A multiple linear regression analysis was used to find the variables independently associated with each outcome. Seventy-five adult patients were evaluated. After multiple linear regression analysis, the HADS scores were associated with all outcomes, except social relationships (p = 0.08). Female gender was associated with poor total scores, as well as psychological health and environment. Unemployment was associated with poor physical health. Identifying the factors associated with HRQOL and recognizing that depression and anxiety are major factors are essential to improve the care of patients.

Bayesian methods to determine performance differences and to quantify variability among centers in multi-center trials: the IHAST trial.

PubMed

Bayman, Emine O; Chaloner, Kathryn M; Hindman, Bradley J; Todd, Michael M

2013-01-16

To quantify the variability among centers and to identify centers whose performance are potentially outside of normal variability in the primary outcome and to propose a guideline that they are outliers. Novel statistical methodology using a Bayesian hierarchical model is used. Bayesian methods for estimation and outlier detection are applied assuming an additive random center effect on the log odds of response: centers are similar but different (exchangeable). The Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) is used as an example. Analyses were adjusted for treatment, age, gender, aneurysm location, World Federation of Neurological Surgeons scale, Fisher score and baseline NIH stroke scale scores. Adjustments for differences in center characteristics were also examined. Graphical and numerical summaries of the between-center standard deviation (sd) and variability, as well as the identification of potential outliers are implemented. In the IHAST, the center-to-center variation in the log odds of favorable outcome at each center is consistent with a normal distribution with posterior sd of 0.538 (95% credible interval: 0.397 to 0.726) after adjusting for the effects of important covariates. Outcome differences among centers show no outlying centers. Four potential outlying centers were identified but did not meet the proposed guideline for declaring them as outlying. Center characteristics (number of subjects enrolled from the center, geographical location, learning over time, nitrous oxide, and temporary clipping use) did not predict outcome, but subject and disease characteristics did. Bayesian hierarchical methods allow for determination of whether outcomes from a specific center differ from others and whether specific clinical practices predict outcome, even when some centers/subgroups have relatively small sample sizes. In the IHAST no outlying centers were found. The estimated variability between centers was moderately large.

Is reflective functioning associated with clinical symptoms and long-term course in patients with personality disorders?

PubMed

Antonsen, Bjørnar T; Johansen, Merete S; Rø, Frida G; Kvarstein, Elfrida H; Wilberg, Theresa

2016-01-01

Mentalization is the capacity to understand behavior as the expression of various mental states and is assumed to be important in a range of psychopathologies, especially personality disorders (PDs). The first aim of the present study was to investigate the relationship between mentalization capacity, operationalized as reflective functioning (RF), and clinical manifestations before entering study treatment. The second aim was to investigate the relationship between baseline RF and long-term clinical outcome both independent of treatment (predictor analyses) and dependent on treatment (moderator analyses). Seventy-nine patients from a randomized clinical trial (Ullevål Personality Project) who had borderline and/or avoidant PD were randomly assigned to either a step-down treatment program, comprising short-term day-hospital treatment followed by outpatient combined group and individual psychotherapy, or to outpatient individual psychotherapy. Patients were evaluated on variables including symptomatic distress, psychosocial functioning, personality functioning, and self-esteem at baseline, 8 and 18months, and 3 and 6years. RF was significantly associated with a wide range of variables at baseline. In longitudinal analyses RF was not found to be a predictor of long-term clinical outcome. However, when considering treatment type, there were significant moderator effects of RF. Patients with low RF had better outcomes in outpatient individual therapy compared to the step-down program. In contrast, patients in the medium RF group achieved better results in the step-down program. These findings indicate that RF is associated with core aspects of personality pathology and capture clinically relevant phenomena in adult patients with PDs. Moreover, patients with different capacities for mentalization may need different kinds of therapeutic approaches. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Association between trends in clinical variables and outcome in intensive care patients with faecal peritonitis: analysis of the GenOSept cohort.

PubMed

Tridente, Ascanio; Clarke, Geraldine M; Walden, Andrew; Gordon, Anthony C; Hutton, Paula; Chiche, Jean-Daniel; Holloway, Paul A H; Mills, Gary H; Bion, Julian; Stüber, Frank; Garrard, Christopher; Hinds, Charles

2015-05-05

Patients admitted to intensive care following surgery for faecal peritonitis present particular challenges in terms of clinical management and risk assessment. Collaborating surgical and intensive care teams need shared perspectives on prognosis. We aimed to determine the relationship between dynamic assessment of trends in selected variables and outcomes. We analysed trends in physiological and laboratory variables during the first week of intensive care unit (ICU) stay in 977 patients at 102 centres across 16 European countries. The primary outcome was 6-month mortality. Secondary endpoints were ICU, hospital and 28-day mortality. For each trend, Cox proportional hazards (PH) regression analyses, adjusted for age and sex, were performed for each endpoint. Trends over the first 7 days of the ICU stay independently associated with 6-month mortality were worsening thrombocytopaenia (mortality: hazard ratio (HR) = 1.02; 95% confidence interval (CI), 1.01 to 1.03; P < 0.001) and renal function (total daily urine output: HR =1.02; 95% CI, 1.01 to 1.03; P < 0.001; Sequential Organ Failure Assessment (SOFA) renal subscore: HR = 0.87; 95% CI, 0.75 to 0.99; P = 0.047), maximum bilirubin level (HR = 0.99; 95% CI, 0.99 to 0.99; P = 0.02) and Glasgow Coma Scale (GCS) SOFA subscore (HR = 0.81; 95% CI, 0.68 to 0.98; P = 0.028). Changes in renal function (total daily urine output and renal component of the SOFA score), GCS component of the SOFA score, total SOFA score and worsening thrombocytopaenia were also independently associated with secondary outcomes (ICU, hospital and 28-day mortality). We detected the same pattern when we analysed trends on days 2, 3 and 5. Dynamic trends in all other measured laboratory and physiological variables, and in radiological findings, changes in respiratory support, renal replacement therapy and inotrope and/or vasopressor requirements failed to be retained as independently associated with outcome in multivariate analysis. Only deterioration in renal function, thrombocytopaenia and SOFA score over the first 2, 3, 5 and 7 days of the ICU stay were consistently associated with mortality at all endpoints. These findings may help to inform clinical decision making in patients with this common cause of critical illness.

Unicystic Ameloblastoma Revisited: Comparison of Massachusetts General Hospital Outcomes With Original Robinson and Martinez Report.

PubMed

Chouinard, Anne-Frédérique; Peacock, Zachary S; Faquin, William C; Kaban, Leonard B

2017-11-01

Robinson and Martinez established unicystic ameloblastoma (UA) as a distinct pathologic entity in 1977. Using their original description, the aims of this study were to compare the clinical presentation and outcomes of UA treated at Massachusetts General Hospital (MGH) with outcomes reported in the original article. This was a retrospective cohort study of MGH patients treated for UA during a 15-year period. Patients were included if they had a confirmed clinical and histologic diagnosis of UA. The primary predictor variable was the source of the study sample (MGH vs Robinson and Martinez). Secondary variables included age, gender, radiographic appearance, treatment, and histologic subtype. The primary outcome variable was the number of recurrences over time comparing the 2 groups. There were 19 patients (10 female and 9 male patients) in the MGH group and 20 patients (10 female and 10 male patients) in the Robinson and Martinez study. The lesions were predominantly unilocular (13 in MGH group and 19 in Robinson and Martinez group), located in the mandible (18 in MGH group and 20 in Robinson and Martinez group), and tooth associated (12 in MGH group and 14 in Robinson and Martinez group). No statistically significant demographic differences were noted between the 2 groups. In the MGH group, 13 cases (68%) exhibited mural or intramural ameloblastic epithelium, 4 (21%) were luminal or intraluminal, and 2 were unknown. However, histologic configuration was not reported in the Robinson and Martinez group. MGH patients were treated by enucleation (n = 7, 37%) or resection (n = 12, 63%) compared with enucleation in 100% cases in the Robinson and Martinez group. Overall, the disease-free survival rate was higher in the Robinson and Martinez group, but the difference was not statistically significant (P = .089). Within the MGH group, 100% of recurrences occurred in patients with mural invasion treated by enucleation. The results of this study support UA as a distinct entity based on demographic, clinical, and radiographic criteria. Outcomes in the MGH group were influenced by the degree of ameloblastic epithelial invasion and suggest that this variable should be considered when planning treatment. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Clinical impact of sepsis at admission to the ICU of a private hospital in Salvador, Brazil.

PubMed

Juncal, Verena Ribeiro; Britto Neto, Lelivaldo Antonio de; Camelier, Aquiles Assunção; Messeder, Octavio Henrique Coelho; Farias, Augusto Manoel de Carvalho

2011-01-01

To describe the clinical characteristics, laboratory data, and clinical outcomes of patients with and without sepsis admitted to the ICU of a private hospital in the city of Salvador, Brazil, and to identify clinical variables related to a worse prognosis in those with sepsis. This was a longitudinal study including all patients admitted to the general ICU of the Hospital Português, in the city of Salvador, Brazil, between June of 2008 and March of 2009. At ICU admission, two groups of patients were identified: with sepsis and without sepsis. Epidemiological, clinical and laboratory data were collected, and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score was calculated. Of the 144 patients in the study, 29 (20.1%) had sepsis. Among the patients with sepsis, males accounted for 55.2%, the mean age was 73.1 ± 14.6 years, and the mean APACHE II score was 23.8 ± 9.1, compared with 36.3%, 68.7 ± 17.7 years, and 18.4 ± 9.5, respectively, among those without sepsis. There were significant associations between a diagnosis of sepsis and the following variables: APACHE II score; in-hospital mortality; ICU mortality; HR; mean arterial pressure; hematocrit level; white blood cell count; and antibiotic use. The use of life support measures and lower hematocrit levels were associated with a worse prognosis in the patients with sepsis. The patients diagnosed with sepsis presented worse clinical outcomes, probably due to their greater severity. Hematocrit level was the only variable that was a predictor of mortality risk in the patients with sepsis.

Dolichoectatic aneurysms of the vertebrobasilar system: clinical and radiographic factors that predict poor outcomes.

PubMed

Xu, David S; Levitt, Michael R; Kalani, M Yashar S; Rangel-Castilla, Leonardo; Mulholland, Celene B; Abecassis, Isaac J; Morton, Ryan P; Nerva, John D; Siddiqui, Adnan H; Levy, Elad I; Spetzler, Robert F; Albuquerque, Felipe C; McDougall, Cameron G

2018-02-01

OBJECTIVE Fusiform dolichoectatic vertebrobasilar aneurysms are rare, challenging lesions. The natural history of these lesions and medium- and long-term patient outcomes are poorly understood. The authors sought to evaluate patient prognosis after diagnosis of fusiform dolichoectatic vertebrobasilar aneurysms and to identify clinical and radiographic predictors of neurological deterioration. METHODS The authors reviewed multiple, prospectively maintained, single-provider databases at 3 large-volume cerebrovascular centers to obtain data on patients with unruptured, fusiform, basilar artery dolichoectatic aneurysms diagnosed between January 1, 2000, and January 1, 2015. RESULTS A total of 50 patients (33 men, 17 women) were identified; mean clinical follow-up was 50.1 months and mean radiographic follow-up was 32.4 months. At last follow-up, 42% (n = 21) of aneurysms had progressed and 44% (n = 22) of patients had deterioration of their modified Rankin Scale scores. When patients were dichotomized into 2 groups- those who worsened and those who did not-univariate analysis showed 5 variables to be statistically significantly different: sex (p = 0.007), radiographic brainstem compression (p = 0.03), clinical posterior fossa compression (p < 0.001), aneurysmal growth on subsequent imaging (p = 0.001), and surgical therapy (p = 0.006). A binary logistic regression was then created to evaluate these variables. The only variable found to be a statistically significant predictor of clinical worsening was clinical symptoms of posterior fossa compression at presentation (p = 0.01). CONCLUSIONS Fusiform dolichoectatic vertebrobasilar aneurysms carry a poor prognosis, with approximately one-half of the patients deteriorating or experiencing progression of their aneurysm within 5 years. Despite being high risk, intervention-when carefully timed (before neurological decline)-may be beneficial in select patients.

PROGNOSTIC SIGNIFICANCE OF CLINICAL, HISTOPATHOLOGICAL, AND MOLECULAR CHARACTERISTICS OF MEDULLOBLASTOMAS IN THE PROSPECTIVE HIT2000 MULTICENTER CLINICAL TRIAL COHORT

PubMed Central

Pietsch, Torsten; Schmidt, Rene; Remke, Marc; Korshunov, Andrey; Hovestadt, Volker; Jones, David TW; Felsberg, Jörg; Kaulich, Kerstin; Goschzik, Tobias; Kool, Marcel; Northcott, Paul A.; von Hoff, Katja; von Bueren, André O.; Friedrich, Carsten; Skladny, Heyko; Fleischhack, Gudrun; Taylor, Michael D.; Cremer, Friedrich; Lichter, Peter; Faldum, Andreas; Reifenberger, Guido; Rutkowski, Stefan; Pfister, Stefan M.

2014-01-01

BACKGROUND: This study aimed to prospectively evaluate clinical, histopathological and molecular variables for outcome prediction in medulloblastoma patients. METHODS: Patients from the HIT2000 cooperative clinical trial were prospectively enrolled based on the availability of sufficient tumor material and complete clinical information. This revealed a cohort of 184 patients (median age 7.6 years), which was randomly split at a 2:1 ratio into a training (n = 127), and a validation (n = 57) dataset. All samples were subjected to thorough histopathological investigation, CTNNB1 mutation analysis, quantitative PCR, MLPA and FISH analyses for cytogenetic variables, and methylome analysis. RESULTS: By univariable analysis, clinical factors (M-stage), histopathological variables (large cell component, endothelial proliferation, synaptophysin pattern), and molecular features (chromosome 6q status, MYC amplification, TOP2A copy-number, subgrouping) were found to be prognostic. Molecular consensus subgrouping (WNT, SHH, Group 3, Group 4) was validated as an independent feature to stratify patients into different risk groups. When comparing methods for the identification of WNT-driven medulloblastoma, this study identified CTNNB1 sequencing and methylation profiling to most reliably identify these patients. After removing patients with particularly favorable (CTNNB1 mutation, extensive nodularity) or unfavorable (MYC amplification) markers, a risk score for the remaining “intermediate molecular risk” population dependent on age, M-stage, pattern of synaptophysin expression, and MYCN copy-number status was identified and validated, with speckled synaptophysin expression indicating worse outcome. CONCLUSIONS: Methylation subgrouping and CTNNB1 mutation status represent robust tools for the risk-stratification of medulloblastoma. A simple clinico-pathological risk score for “intermediate molecular risk” patients was identified, which deserves further validation. SECONDARY CATEGORY: Pediatrics.

Moderate efficiency of clinicians' predictions decreased for blurred clinical conditions and benefits from the use of BRASS index. A longitudinal study on geriatric patients' outcomes.

PubMed

Signorini, Giulia; Dagani, Jessica; Bulgari, Viola; Ferrari, Clarissa; de Girolamo, Giovanni

2016-01-01

Accurate prognosis is an essential aspect of good clinical practice and efficient health services, particularly for chronic and disabling diseases, as in geriatric populations. This study aims to examine the accuracy of clinical prognostic predictions and to devise prediction models combining clinical variables and clinicians' prognosis for a geriatric patient sample. In a sample of 329 consecutive older patients admitted to 10 geriatric units, we evaluated the accuracy of clinicians' prognosis regarding three outcomes at discharge: global functioning, length of stay (LoS) in hospital, and destination at discharge (DD). A comprehensive set of sociodemographic, clinical, and treatment-related information were also collected. Moderate predictive performance was found for all three outcomes: area under receiver operating characteristic curve of 0.79 and 0.78 for functioning and LoS, respectively, and moderate concordance, Cohen's K = 0.45, between predicted and observed DD. Predictive models found the Blaylock Risk Assessment Screening Score together with clinicians' judgment relevant to improve predictions for all outcomes (absolute improvement in adjusted and pseudo-R(2) up to 19%). Although the clinicians' estimates were important factors in predicting global functioning, LoS, and DD, more research is needed regarding both methodological aspects and clinical measurements, to improve prognostic clinical indices. Copyright © 2016 Elsevier Inc. All rights reserved.

Quantitative appraisal of the Amyloid Imaging Taskforce appropriate use criteria for amyloid-PET.

PubMed

Altomare, Daniele; Ferrari, Clarissa; Festari, Cristina; Guerra, Ugo Paolo; Muscio, Cristina; Padovani, Alessandro; Frisoni, Giovanni B; Boccardi, Marina

2018-04-18

We test the hypothesis that amyloid-PET prescriptions, considered appropriate based on the Amyloid Imaging Taskforce (AIT) criteria, lead to greater clinical utility than AIT-inappropriate prescriptions. We compared the clinical utility between patients who underwent amyloid-PET appropriately or inappropriately and among the subgroups of patients defined by the AIT criteria. Finally, we performed logistic regressions to identify variables associated with clinical utility. We identified 171 AIT-appropriate and 67 AIT-inappropriate patients. AIT-appropriate and AIT-inappropriate cases did not differ in any outcomes of clinical utility (P > .05). Subgroup analysis denoted both expected and unexpected results. The logistic regressions outlined the primary role of clinical picture and clinical or neuropsychological profile in identifying patients benefitting from amyloid-PET. Contrary to our hypothesis, also AIT-inappropriate prescriptions were associated with clinical utility. Clinical or neuropsychological variables, not taken into account by the AIT criteria, may help further refine criteria for appropriateness. Copyright © 2018. Published by Elsevier Inc.

Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

PubMed Central

Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

2007-01-01

Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compared with “pure” bipolar patients (n = 10) with regard to demographic, clinical, and course of illness variables. Comorbid personality disorder was diagnosed in 75% of patients according to ICD-10 criteria, with obsessive-compulsive personality disorder being the most frequent type. Sixty-three per cent of subjects had more than one comorbid personality disorder. Bipolar patients with and without comorbid personality disorder showed no significant differences regarding features of the bipolar illness, although the group with comorbid personality disorder showed a younger age at onset, more depressive episodes, and longer duration of bipolar illness. In subjects with comorbid personality disorders, the number of hospitalizations correlated significantly with depressive episodes and there was an inverse correlation between age at the first episode and duration of bipolar illness. These findings, however, should be interpreted taking into account the preliminary nature of a pilot study and the contamination of the sample with too many bipolar II patients. PMID:19300559

Validity and clinical utility of the DSM-5 severity specifier for bulimia nervosa: results from a multisite sample of patients who received evidence-based treatment.

PubMed

Dakanalis, Antonios; Bartoli, Francesco; Caslini, Manuela; Crocamo, Cristina; Zanetti, Maria Assunta; Riva, Giuseppe; Clerici, Massimo; Carrà, Giuseppe

2017-12-01

A new "severity specifier" for bulimia nervosa (BN), based on the frequency of inappropriate weight compensatory behaviours (IWCBs), was added to the DSM-5 as a means of documenting heterogeneity and variability in the severity of the disorder. Yet, evidence for its validity in clinical populations, including prognostic significance for treatment outcome, is currently lacking. Existing data from 281 treatment-seeking patients with DSM-5 BN, who received the best available treatment for their disorder (manual-based cognitive behavioural therapy; CBT) in an outpatient setting, were re-analysed to examine whether these patients subgrouped based on the DSM-5 severity levels would show meaningful and consistent differences on (a) a range of clinical variables assessed at pre-treatment and (b) post-treatment abstinence from IWCBs. Results highlight that the mild, moderate, severe, and extreme severity groups were statistically distinguishable on 22 variables assessed at pre-treatment regarding eating disorder pathological features, maintenance factors of BN, associated (current) and lifetime psychopathology, social maladjustment and illness-specific functional impairment, and abstinence outcome. Mood intolerance, a maintenance factor of BN but external to eating disorder pathological features (typically addressed within CBT), emerged as the primary clinical variable distinguishing the severity groups showing a differential treatment response. Overall, the findings speak to the concurrent and predictive validity of the new DSM-5 severity criterion for BN and are important because a common benchmark informing patients, clinicians, and researchers about severity of the disorder and allowing severity fluctuation and patient's progress to be tracked does not exist so far. Implications for future research are outlined.

Clinical Audit of COPD Patients Requiring Hospital Admissions in Spain: AUDIPOC Study

PubMed Central

Pozo-Rodríguez, Francisco; López-Campos, Jose Luis; Álvarez-Martínez, Carlos J.; Castro-Acosta, Ady; Agüero, Ramón; Hueto, Javier; Hernández-Hernández, Jesús; Barrón, Manuel; Abraira, Victor; Forte, Anabel; Sanchez Nieto, Juan Miguel; Lopez-Gabaldón, Encarnación; Cosío, Borja G.; Agustí, Alvar

2012-01-01

Backgrounds AUDIPOC is a nationwide clinical audit that describes the characteristics, interventions and outcomes of patients admitted to Spanish hospitals because of an exacerbation of chronic obstructive pulmonary disease (ECOPD), assessing the compliance of these parameters with current international guidelines. The present study describes hospital resources, hospital factors related to case recruitment variability, patients’ characteristics, and adherence to guidelines. Methodology/Principal Findings An organisational database was completed by all participant hospitals recording resources and organisation. Over an 8-week period 11,564 consecutive ECOPD admissions to 129 Spanish hospitals covering 70% of the Spanish population were prospectively identified. At hospital discharge, 5,178 patients (45% of eligible) were finally included, and thus constituted the audited population. Audited patients were reassessed 90 days after admission for survival and readmission rates. A wide variability was observed in relation to most variables, hospital adherence to guidelines, and readmissions and death. Median inpatient mortality was 5% (across-hospital range 0–35%). Among discharged patients, 37% required readmission (0–62%) and 6.5% died (0–35%). The overall mortality rate was 11.6% (0–50%). Hospital size and complexity and aspects related to hospital COPD awareness were significantly associated with case recruitment. Clinical management most often complied with diagnosis and treatment recommendations but rarely (<50%) addressed guidance on healthy life-styles. Conclusions/Significance The AUDIPOC study highlights the large across-hospital variability in resources and organization of hospitals, patient characteristics, process of care, and outcomes. The study also identifies resources and organizational characteristics associated with the admission of COPD cases, as well as aspects of daily clinical care amenable to improvement. PMID:22911875

CBT competence in novice therapists improves anxiety outcomes.

PubMed

Brown, Lily A; Craske, Michelle G; Glenn, Daniel E; Stein, Murray B; Sullivan, Greer; Sherbourne, Cathy; Bystritsky, Alexander; Welch, Stacy S; Campbell-Sills, Laura; Lang, Ariel; Roy-Byrne, Peter; Rose, Raphael D

2013-02-01

This study explores the relationships between therapist variables (cognitive behavioral therapy [CBT] competence, and CBT adherence) and clinical outcomes of computer-assisted CBT for anxiety disorders delivered by novice therapists in a primary care setting. Participants were recruited for a randomized controlled trial of evidence-based treatment, including computer-assisted CBT, versus treatment as usual. Therapists (anxiety clinical specialists; ACSs) were nonexpert clinicians, many of whom had no prior experience in delivering psychotherapy (and in particular, very little experience with CBT). Trained raters reviewed randomly selected treatment sessions from 176 participants and rated therapists on measures of CBT competence and CBT adherence. Patients were assessed at baseline and at 6-, 12-, and 18-month follow-ups on measures of anxiety, depression, and functioning, and an average Reliable Change Index was calculated as a composite measure of outcome. CBT competence and CBT adherence were entered as predictors of outcome, after controlling for baseline covariates. Higher CBT competence was associated with better clinical outcomes whereas CBT adherence was not. Also, CBT competence was inversely correlated with years of clinical experience and trended (not significantly, though) down as the study progressed. CBT adherence was inversely correlated with therapist tenure in the study. Therapist competence was related to improved clinical outcomes when CBT for anxiety disorders was delivered by novice clinicians with technology assistance. The results highlight the value of the initial training for novice therapists as well as booster training to limit declines in therapist adherence. © 2012 Wiley Periodicals, Inc.

CBT competence in novice therapists improves anxiety outcomes

PubMed Central

Brown, Lily A.; Craske, Michelle G.; Glenn, Daniel E.; Stein, Murray B.; Sullivan, Greer; Sherbourne, Cathy; Bystritsky, Alexander; Welch, Stacy S.; Campbell-Sills, Laura; Lang, Ariel; Roy-Byrne, Peter; Rose, Raphael D.

2013-01-01

Objective This study explores the relationships between therapist variables (CBT competence, and CBT adherence) and clinical outcomes of computer-assisted CBT for anxiety disorders delivered by novice therapists in a primary care setting. Methods Participants were recruited for a randomized controlled trial of evidence-based treatment, including computer-assisted CBT, versus treatment as usual. Therapists (Anxiety Clinical Specialists; ACSs) were non-expert clinicians, many of whom had no prior experience in delivering psychotherapy (and in particular, very little experience with CBT). Trained raters reviewed randomly selected treatment sessions from 176 participants and rated therapists on measures of CBT-competence and CBT-adherence. Patients were assessed at baseline and at 6, 12, and 18 month follow-ups on measures of anxiety, depression, and functioning, and an average reliable change index was calculated as a composite measure of outcome. CBT-competence and CBT-adherence were entered as predictors of outcome, after controlling for baseline covariates. Results Higher CBT-competence was associated with better clinical outcomes whereas CBT-adherence was not. Also, CBT-competence was inversely correlated with years of clinical experience and trended (not significantly, though) down as the study progressed. CBT-adherence was inversely correlated with therapist tenure in the study. Conclusions Therapist competence was related to improved clinical outcomes when CBT for anxiety disorders was delivered by novice clinicians with technology assistance. The results highlight the value of the initial training for novice therapists as well as booster training to limit declines in therapist adherence. PMID:23225338

Quantitative EEG Metrics Differ Between Outcome Groups and Change Over the First 72 h in Comatose Cardiac Arrest Patients.

PubMed

Wiley, Sara Leingang; Razavi, Babak; Krishnamohan, Prashanth; Mlynash, Michael; Eyngorn, Irina; Meador, Kimford J; Hirsch, Karen G

2018-02-01

Forty to sixty-six percent of patients resuscitated from cardiac arrest remain comatose, and historic outcome predictors are unreliable. Quantitative spectral analysis of continuous electroencephalography (cEEG) may differ between patients with good and poor outcomes. Consecutive patients with post-cardiac arrest hypoxic-ischemic coma undergoing cEEG were enrolled. Spectral analysis was conducted on artifact-free contiguous 5-min cEEG epochs from each hour. Whole band (1-30 Hz), delta (δ, 1-4 Hz), theta (θ, 4-8 Hz), alpha (α, 8-13 Hz), beta (β, 13-30 Hz), α/δ power ratio, percent suppression, and variability were calculated and correlated with outcome. Graphical patterns of quantitative EEG (qEEG) were described and categorized as correlating with outcome. Clinical outcome was dichotomized, with good neurologic outcome being consciousness recovery. Ten subjects with a mean age = 50 yrs (range = 18-65) were analyzed. There were significant differences in total power (3.50 [3.30-4.06] vs. 0.68 [0.52-1.02], p = 0.01), alpha power (1.39 [0.66-1.79] vs 0.27 [0.17-0.48], p < 0.05), delta power (2.78 [2.21-3.01] vs 0.55 [0.38-0.83], p = 0.01), percent suppression (0.66 [0.02-2.42] vs 73.4 [48.0-97.5], p = 0.01), and multiple measures of variability between good and poor outcome patients (all values median [IQR], good vs. poor). qEEG patterns with high or increasing power or large power variability were associated with good outcome (n = 6). Patterns with consistently low or decreasing power or minimal power variability were associated with poor outcome (n = 4). These preliminary results suggest qEEG metrics correlate with outcome. In some patients, qEEG patterns change over the first three days post-arrest.

Proton pump inhibitors: from CYP2C19 pharmacogenetics to precision medicine.

PubMed

El Rouby, Nihal; Lima, John J; Johnson, Julie A

2018-04-01

Proton Pump inhibitors (PPIs) are commonly used for a variety of acid related disorders. Despite the overall effectiveness and safety profile of PPIs, some patients do not respond adequately or develop treatment related adverse events. This variable response among patients is in part due to genotype variability of CYP2C19, the gene encoding the CYP450 (CYP2C19) isoenzyme responsible for PPIs metabolism. Areas covered: This article provides an overview of the pharmacokinetics and mechanism of action of the currently available PPIs, including the magnitude of CYPC19 contribution to their metabolism. Additionally, the role of CYP2C19 genetic variability in the therapeutic effectiveness or outcomes of PPI therapy is highlighted in details, to provide supporting evidence for the potential value of CYP2C19 genotype-guided approaches to PPI drug therapy. Expert opinion: There is a large body of evidence describing the impact of CYP2C19 variability on PPIs and its potential role in individualizing PPI therapy, yet, CYP2C19 pharmacogenetics has not been widely implemented into clinical practice. More data are needed but CYP2C19 genotype-guided dosing of PPIs is likely to become increasingly common and is expected to improve clinical outcomes, and minimize side effects related to PPIs.

Proton pump inhibitors: from CYP2C19 pharmacogenetics to precision medicine

PubMed Central

El Rouby, Nihal; Lima, John J.; Johnson, Julie A.

2018-01-01

ABSTRACT Introduction: Proton Pump inhibitors (PPIs) are commonly used for a variety of acid related disorders. Despite the overall effectiveness and safety profile of PPIs, some patients do not respond adequately or develop treatment related adverse events. This variable response among patients is in part due to genotype variability of CYP2C19, the gene encoding the CYP450 (CYP2C19) isoenzyme responsible for PPIs metabolism. Areas covered: This article provides an overview of the pharmacokinetics and mechanism of action of the currently available PPIs, including the magnitude of CYPC19 contribution to their metabolism. Additionally, the role of CYP2C19 genetic variability in the therapeutic effectiveness or outcomes of PPI therapy is highlighted in details, to provide supporting evidence for the potential value of CYP2C19 genotype-guided approaches to PPI drug therapy. Expert opinion: There is a large body of evidence describing the impact of CYP2C19 variability on PPIs and its potential role in individualizing PPI therapy, yet, CYP2C19 pharmacogenetics has not been widely implemented into clinical practice. More data are needed but CYP2C19 genotype-guided dosing of PPIs is likely to become increasingly common and is expected to improve clinical outcomes, and minimize side effects related to PPIs. PMID:29620484

Neurointerventional Treatment in Acute Stroke. Whom to Treat? (Endovascular Treatment for Acute Stroke: Utility of THRIVE Score and HIAT Score for Patient Selection)

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

Fjetland, Lars, E-mail: lars.fjetland@lyse.net; Roy, Sumit, E-mail: sumit.roy@sus.no; Kurz, Kathinka D., E-mail: kathinka.dehli.kurz@sus.no

2013-10-15

Purpose: Intra-arterial therapy (IAT) is used increasingly as a treatment option for acute stroke caused by central large vessel occlusions. Despite high rates of recanalization, the clinical outcome is highly variable. The authors evaluated the Houston IAT (HIAT) and the totaled health risks in vascular events (THRIVE) score, two predicting scores designed to identify patients likely to benefit from IAT. Methods: Fifty-two patients treated at the Stavanger University Hospital with IAT from May 2009 to June 2012 were included in this study. We combined the scores in an additional analysis. We also performed an additional analysis according to high agemore » and evaluated the scores in respect of technical efficacy. Results: Fifty-two patients were evaluated by the THRIVE score and 51 by the HIAT score. We found a strong correlation between the level of predicted risk and the actual clinical outcome (THRIVE p = 0.002, HIAT p = 0.003). The correlations were limited to patients successfully recanalized and to patients <80 years. By combining the scores additional 14.3 % of the patients could be identified as poor candidates for IAT. Both scores were insufficient to identify patients with a good clinical outcome. Conclusions: Both scores showed a strong correlation to poor clinical outcome in patients <80 years. The specificity of the scores could be enhanced by combining them. Both scores were insufficient to identify patients with a good clinical outcome and showed no association to clinical outcome in patients aged {>=}80 years.« less

Predictors, Moderators, and Mediators of Treatment Outcome Following Manualised Cognitive-Behavioural Therapy for Eating Disorders: A Systematic Review.

PubMed

Linardon, Jake; de la Piedad Garcia, Xochitl; Brennan, Leah

2017-01-01

This systematic review synthesised the literature on predictors, moderators, and mediators of outcome following Fairburn's CBT for eating disorders. Sixty-five articles were included. The relationship between individual variables and outcome was synthesised separately across diagnoses and treatment format. Early change was found to be a consistent mediator of better outcomes across all eating disorders. Moderators were mostly tested in binge eating disorder, and most moderators did not affect cognitive-behavioural treatment outcome relative to other treatments. No consistent predictors emerged. Findings suggest that it is unclear how and for whom this treatment works. More research testing mediators and moderators is needed, and variables selected for analyses need to be empirically and theoretically driven. Future recommendations include the need for authors to (i) interpret the clinical and statistical significance of findings; (ii) use a consistent definition of outcome so that studies can be directly compared; and (iii) report null and statistically significant findings. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association. © 2016 John Wiley & Sons, Ltd and Eating Disorders Association.

Pain Sensitivity Subgroups in Individuals With Spine Pain: Potential Relevance to Short-Term Clinical Outcome

PubMed Central

Bialosky, Joel E.; Robinson, Michael E.

2014-01-01

Background Cluster analysis can be used to identify individuals similar in profile based on response to multiple pain sensitivity measures. There are limited investigations into how empirically derived pain sensitivity subgroups influence clinical outcomes for individuals with spine pain. Objective The purposes of this study were: (1) to investigate empirically derived subgroups based on pressure and thermal pain sensitivity in individuals with spine pain and (2) to examine subgroup influence on 2-week clinical pain intensity and disability outcomes. Design A secondary analysis of data from 2 randomized trials was conducted. Methods Baseline and 2-week outcome data from 157 participants with low back pain (n=110) and neck pain (n=47) were examined. Participants completed demographic, psychological, and clinical information and were assessed using pain sensitivity protocols, including pressure (suprathreshold pressure pain) and thermal pain sensitivity (thermal heat threshold and tolerance, suprathreshold heat pain, temporal summation). A hierarchical agglomerative cluster analysis was used to create subgroups based on pain sensitivity responses. Differences in data for baseline variables, clinical pain intensity, and disability were examined. Results Three pain sensitivity cluster groups were derived: low pain sensitivity, high thermal static sensitivity, and high pressure and thermal dynamic sensitivity. There were differences in the proportion of individuals meeting a 30% change in pain intensity, where fewer individuals within the high pressure and thermal dynamic sensitivity group (adjusted odds ratio=0.3; 95% confidence interval=0.1, 0.8) achieved successful outcomes. Limitations Only 2-week outcomes are reported. Conclusions Distinct pain sensitivity cluster groups for individuals with spine pain were identified, with the high pressure and thermal dynamic sensitivity group showing worse clinical outcome for pain intensity. Future studies should aim to confirm these findings. PMID:24764070

Exact tests using two correlated binomial variables in contemporary cancer clinical trials.

PubMed

Yu, Jihnhee; Kepner, James L; Iyer, Renuka

2009-12-01

New therapy strategies for the treatment of cancer are rapidly emerging because of recent technology advances in genetics and molecular biology. Although newer targeted therapies can improve survival without measurable changes in tumor size, clinical trial conduct has remained nearly unchanged. When potentially efficacious therapies are tested, current clinical trial design and analysis methods may not be suitable for detecting therapeutic effects. We propose an exact method with respect to testing cytostatic cancer treatment using correlated bivariate binomial random variables to simultaneously assess two primary outcomes. The method is easy to implement. It does not increase the sample size over that of the univariate exact test and in most cases reduces the sample size required. Sample size calculations are provided for selected designs.

Heart rate variability measurement and clinical depression in acute coronary syndrome patients: narrative review of recent literature

PubMed Central

Harris, Patricia RE; Sommargren, Claire E; Stein, Phyllis K; Fung, Gordon L; Drew, Barbara J

2014-01-01

Aim We aimed to explore links between heart rate variability (HRV) and clinical depression in patients with acute coronary syndrome (ACS), through a review of recent clinical research literature. Background Patients with ACS are at risk for both cardiac autonomic dysfunction and clinical depression. Both conditions can negatively impact the ability to recover from an acute physiological insult, such as unstable angina or myocardial infarction, increasing the risk for adverse cardiovascular outcomes. HRV is recognized as a reflection of autonomic function. Methods A narrative review was undertaken to evaluate state-of-the-art clinical research, using the PubMed database, January 2013. The search terms “heart rate variability” and “depression” were used in conjunction with “acute coronary syndrome”, “unstable angina”, or “myocardial infarction” to find clinical studies published within the past 10 years related to HRV and clinical depression, in patients with an ACS episode. Studies were included if HRV measurement and depression screening were undertaken during an ACS hospitalization or within 2 months of hospital discharge. Results Nine clinical studies met the inclusion criteria. The studies’ results indicate that there may be a relationship between abnormal HRV and clinical depression when assessed early after an ACS event, offering the possibility that these risk factors play a modest role in patient outcomes. Conclusion While a definitive conclusion about the relevance of HRV and clinical depression measurement in ACS patients would be premature, the literature suggests that these measures may provide additional information in risk assessment. Potential avenues for further research are proposed. PMID:25071372

Drug Concentration Thresholds Predictive of Therapy Failure and Death in Children With Tuberculosis: Bread Crumb Trails in Random Forests

PubMed Central

Swaminathan, Soumya; Pasipanodya, Jotam G.; Ramachandran, Geetha; Hemanth Kumar, A. K.; Srivastava, Shashikant; Deshpande, Devyani; Nuermberger, Eric; Gumbo, Tawanda

2016-01-01

Background. The role of drug concentrations in clinical outcomes in children with tuberculosis is unclear. Target concentrations for dose optimization are unknown. Methods. Plasma drug concentrations measured in Indian children with tuberculosis were modeled using compartmental pharmacokinetic analyses. The children were followed until end of therapy to ascertain therapy failure or death. An ensemble of artificial intelligence algorithms, including random forests, was used to identify predictors of clinical outcome from among 30 clinical, laboratory, and pharmacokinetic variables. Results. Among the 143 children with known outcomes, there was high between-child variability of isoniazid, rifampin, and pyrazinamide concentrations: 110 (77%) completed therapy, 24 (17%) failed therapy, and 9 (6%) died. The main predictors of therapy failure or death were a pyrazinamide peak concentration <38.10 mg/L and rifampin peak concentration <3.01 mg/L. The relative risk of these poor outcomes below these peak concentration thresholds was 3.64 (95% confidence interval [CI], 2.28–5.83). Isoniazid had concentration-dependent antagonism with rifampin and pyrazinamide, with an adjusted odds ratio for therapy failure of 3.00 (95% CI, 2.08–4.33) in antagonism concentration range. In regard to death alone as an outcome, the same drug concentrations, plus z scores (indicators of malnutrition), and age <3 years, were highly ranked predictors. In children <3 years old, isoniazid 0- to 24-hour area under the concentration-time curve <11.95 mg/L × hour and/or rifampin peak <3.10 mg/L were the best predictors of therapy failure, with relative risk of 3.43 (95% CI, .99–11.82). Conclusions. We have identified new antibiotic target concentrations, which are potential biomarkers associated with treatment failure and death in children with tuberculosis. PMID:27742636

Experience by children and adolescents of more than one type of maltreatment: Association of different classes of maltreatment profiles with clinical outcome variables.

PubMed

Witt, Andreas; Münzer, Annika; Ganser, Helene G; Fegert, Jörg M; Goldbeck, Lutz; Plener, Paul L

2016-07-01

Most victims of child abuse have experienced more than one type of maltreatment, yet there is a lack of understanding of the impact of specific combinations of types of maltreatment. This study aimed to identify meaningful classes of maltreatment profiles and to associate them with short-term clinical outcomes. A total of 358 German children and adolescents aged 4-17 with a known history of child maltreatment were included in the study. Through interviews and questionnaires, information was obtained from participants and their primary caregivers on history of maltreatment, sociodemographics, psychopathology, level of psychosocial functioning, and health-related quality of life. Types of abuse were categorized into six major groups: sexual abuse in general, sexual abuse with penetration, physical abuse, emotional abuse, neglect, and exposure to domestic violence. A latent class analysis (LCA) was performed to determine distinct multi-type maltreatment profiles, which were then assessed for their associations with the sociodemographic and clinical outcome variables. The LCA revealed that participants could be categorized into three meaningful classes according to history of maltreatment: (1) experience of multiple types of maltreatment excluding sexual abuse (63.1%), (2) experience of multiple types of maltreatment including sexual abuse (26.5%), and (3) experience of predominantly sexual abuse (10.3%). Members of Class 2 showed significantly worse short-term outcomes on psychopathology, level of functioning, and quality of life compared to the other classes. Three distinct profiles of multiple types of maltreatment were empirically identified in this sample. Exposure to multiple types of abuse was associated with poorer outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting

PubMed Central

2010-01-01

Background High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD; Methods/Design This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic ≥ 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded; Discussion The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting; Trial registration The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov]. PMID:20673325

The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients

PubMed Central

Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun

2016-01-01

Abstract Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients. HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization. A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan–Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21–2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00–1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12–2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08–2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables. Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients. PMID:27175661

Sociodemographic, clinical, and work characteristics associated with return-to-work outcomes following surgery for work-related knee injury.

PubMed

Fan, Jonathan K; McLeod, Christopher B; Koehoorn, Mieke

2010-06-01

This study examined the association between return-to-work (RTW) outcomes and sociodemographic, clinical, and work characteristics among a cohort of injured workers who underwent knee surgery between 2001-2005 in British Columbia, Canada. Workers' compensation databases were used to identify the retrospective cohort and abstract the study variables. Multinomial logistic regression provided odds ratios (OR) and 95% confidence intervals (95% CI) for the association between RTW (unspecified, partial, full, or non-RTW) and the independent variables. Data was abstracted for 1394 injured workers. Compared to men, women were more likely to have partial RTW (OR 2.55, 95% CI 1.53-4.23) and non-RTW (OR 2.61, 95% CI 1.35-5.03) than full RTW; low income earners were more likely than high income earners to have partial RTW (OR 3.05, 95% CI 1.86-4.99) and non-RTW (OR 4.07, 95% CI 2.19-7.57). Moreover, workers in trade, primary resource, and processing/manufacturing occupations were more likely than those in management occupations to have non-RTW than full RTW by the end of follow-up (OR 2.97, 95% CI 1.32-6.68; OR 9.31, 95% CI 3.41-25.41, and OR 2.71, 95% CI 1.07-6.5, respectively). Surgical and clinical factors were not associated with RTW outcomes. Using population-based data, our study found a link between sociodemographic and work characteristics and the type of RTW outcome following knee surgery for a work-related injury. Women and lower income earners tended not to have full RTW, after controlling for covariates. Workers in physically demanding occupations also tended not to have full RTW, suggesting that factors beyond clinical and surgical characteristics influence disability outcomes. RTW programs need to take into consideration these broader determinants of worker health.

The evolving field of prognostication and risk stratification in MDS: Recent developments and future directions.

PubMed

Lee, Eun-Ju; Podoltsev, Nikolai; Gore, Steven D; Zeidan, Amer M

2016-01-01

The clinical course of patients with myelodysplastic syndromes (MDS) is characterized by wide variability reflecting the underlying genetic and biological heterogeneity of the disease. Accurate prediction of outcomes for individual patients is an integral part of the evidence-based risk/benefit calculations that are necessary for tailoring the aggressiveness of therapeutic interventions. While several prognostication tools have been developed and validated for risk stratification, each of these systems has limitations. The recent progress in genomic sequencing techniques has led to discoveries of recurrent molecular mutations in MDS patients with independent impact on relevant clinical outcomes. Reliable assays of these mutations have already entered the clinic and efforts are currently ongoing to formally incorporate mutational analysis into the existing clinicopathologic risk stratification tools. Additionally, mutational analysis holds promise for going beyond prognostication to therapeutic selection and individualized treatment-specific prediction of outcomes; abilities that would revolutionize MDS patient care. Despite these exciting developments, the best way of incorporating molecular testing for use in prognostication and prediction of outcomes in clinical practice remains undefined and further research is warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Protocol for a prospective collaborative systematic review and meta-analysis of individual patient data from randomized controlled trials of vasoactive drugs in acute stroke: The Blood pressure in Acute Stroke Collaboration, stage-3.

PubMed

Sandset, Else Charlotte; Sanossian, Nerses; Woodhouse, Lisa J; Anderson, Craig; Berge, Eivind; Lees, Kennedy R; Potter, John F; Robinson, Thompson G; Sprigg, Nikola; Wardlaw, Joanna M; Bath, Philip M

2018-01-01

Rationale Despite several large clinical trials assessing blood pressure lowering in acute stroke, equipoise remains particularly for ischemic stroke. The "Blood pressure in Acute Stroke Collaboration" commenced in the mid-1990s focussing on systematic reviews and meta-analysis of blood pressure lowering in acute stroke. From the start, Blood pressure in Acute Stroke Collaboration planned to assess safety and efficacy of blood pressure lowering in acute stroke using individual patient data. Aims To determine the optimal management of blood pressure in patients with acute stroke, including both intracerebral hemorrhage and ischemic stroke. Secondary aims are to assess which clinical and therapeutic factors may alter the optimal management of high blood pressure in patients with acute stroke and to assess the effect of vasoactive treatments on hemodynamic variables. Methods and design Individual patient data from randomized controlled trials of blood pressure management in participants with ischemic stroke and/or intracerebral hemorrhage enrolled during the ultra-acute (pre-hospital), hyper-acute (<6 h), acute (<48 h), and sub-acute (<168 h) phases of stroke. Study outcomes The primary effect variable will be functional outcome defined by the ordinal distribution of the modified Rankin Scale; analyses will also be carried out in pre-specified subgroups to assess the modifying effects of stroke-related and pre-stroke patient characteristics. Key secondary variables will include clinical, hemodynamic and neuroradiological variables; safety variables will comprise death and serious adverse events. Discussion Study questions will be addressed in stages, according to the protocol, before integrating these into a final overreaching analysis. We invite eligible trials to join the collaboration.

Patients presenting to an outpatient sport medicine clinic with concussion

PubMed Central

Ouellet, Jérôme; Boisvert, Leslie; Fischer, Lisa

2016-01-01

Abstract Objective To describe the characteristics of patients who presented to outpatient sport and exercise medicine clinics with concussion. Design Retrospective chart review of electronic medical records. Setting Three specialized sport and exercise medicine clinics in London, Ont. Participants A total of 283 patients presenting with concussion. Main outcome measures Data collected included demographic variables (age and sex), sport participation at the time of injury, previous medical history (including history of concussion), Post-Concussion Symptom Scale (PCSS) scores, and return-to-play (RTP) variables (delay and outcome). Results The mean age of patients presenting for care was 17.6 years; 70.9% of patients were younger than 18 years of age (considered pediatric patients); 58.8% of patients were male; and 31.7% of patients had a previous history of concussion. The main sports associated with injury were hockey (40.0%), soccer (12.6%), and football (11.7%). Return to play was granted to 50.9% of patients before the 3-week mark and 80.2% of patients before 8 weeks. Total PCSS scores (maximum score was 132) and neck scores (part of the PCSS, maximum score was 6) were significantly higher in adults compared with pediatric patients (36.2 vs 27.6, P = .02, and 1.8 vs 1.2, P = .02, respectively). A significant difference was seen in RTP, with pediatric patients returning earlier than adults did (P = .04). This difference was not seen when comparing males with females (P = .07). Longer duration of follow-up did not influence RTP outcomes. Previous history of concussion was associated with restriction from contact or collision sports (P < .001). Conclusion Given the age and sex variability found in this study, as well as in previous published reports, it is important to manage each patient individually using current best available practice strategies to optimize long-term outcomes.

Rapid improvements in emotion regulation predict intensive treatment outcome for patients with bulimia nervosa and purging disorder.

PubMed

MacDonald, Danielle E; Trottier, Kathryn; Olmsted, Marion P

2017-10-01

Rapid and substantial behavior change (RSBC) early in cognitive behavior therapy (CBT) for eating disorders is the strongest known predictor of treatment outcome. Rapid change in other clinically relevant variables may also be important. This study examined whether rapid change in emotion regulation predicted treatment outcomes, beyond the effects of RSBC. Participants were diagnosed with bulimia nervosa or purging disorder (N = 104) and completed ≥6 weeks of CBT-based intensive treatment. Hierarchical regression models were used to test whether rapid change in emotion regulation variables predicted posttreatment outcomes, defined in three ways: (a) binge/purge abstinence; (b) cognitive eating disorder psychopathology; and (c) depression symptoms. Baseline psychopathology and emotion regulation difficulties and RSBC were controlled for. After controlling for baseline variables and RSBC, rapid improvement in access to emotion regulation strategies made significant unique contributions to the prediction of posttreatment binge/purge abstinence, cognitive psychopathology of eating disorders, and depression symptoms. Individuals with eating disorders who rapidly improve their belief that they can effectively modulate negative emotions are more likely to achieve a variety of good treatment outcomes. This supports the formal inclusion of emotion regulation skills early in CBT, and encouraging patient beliefs that these strategies are helpful. © 2017 Wiley Periodicals, Inc.

Child and Adolescent Emergency and Urgent Mental Health Delivery Through Telepsychiatry: 12-Month Prospective Study.

PubMed

Roberts, Nasreen; Hu, Tina; Axas, Nicholas; Repetti, Leanne

2017-10-01

The significant gap between children and adolescents presenting for emergency mental healthcare and the shortage of child and adolescent psychiatrists constitutes a major barrier to timely access for psychiatric assessment for rural and remote areas. Unlike remote areas, urban emergency departments have in-house psychiatric consultation. Telepsychiatry may be a solution to ensure the same service for remote areas. However, there is a paucity of studies on the use of telepsychiatry for child and adolescent emergency consults. Thus, the aim of our study was to (1) assess patient satisfaction with telepsychiatry and (2) compare clinical characteristics and outcome of telepsychiatry with face-to-face emergency child and adolescent assessments. This is a prospective study of telepsychiatry emergency assessments of children and adolescents referred by emergency physicians. The comparison group was age- and gender-matched patients seen for face-to-face urgent assessments. Data were gathered on demographic and clinical variables. Telepsychiatry satisfaction was assessed using a questionnaire. Descriptive statistics and chi-square tests were used to assess group differences for each variable. Logistic regression was used to assess impact of the variables on outcome after the consult. A p value <0.05 was used to determine statistical significance. Sixty (n = 60) assessments were conducted through telepsychiatry in 12 months. Among the telepsychiatry group, Aboriginal patients were over-represented (50% vs. 6.7%, p < 0.001), a higher proportion received a diagnosis of adjustment disorder (22% vs. 8.3%, p = 0.004) or no diagnosis (27% vs. 6.7%, p = 0.004) compared with controls. There was no statistically significant difference between groups on other clinical variables. Patients reported a high degree of satisfaction with telepsychiatry. Telepsychiatry is acceptable to patients and families for safe emergency assessment and follow-up, reducing unnecessary travel to urban centers. Longer time outcomes are needed to establish validity of telepsychiatry for emergency assessments.

Early-Onset Bipolar Disorder: Characteristics and Outcomes in the Clinic.

PubMed

Connor, Daniel F; Ford, Julian D; Pearson, Geraldine S; Scranton, Victoria L; Dusad, Asha

2017-12-01

To assess patient characteristics and clinician-rated outcomes for children diagnosed with early-onset bipolar disorder in comparison to a depressive disorders cohort from a single clinic site. To assess predictors of bipolar treatment response. Medical records from 714 consecutive pediatric patients evaluated and treated at an academic tertiary child and adolescent psychiatry clinic between 2006 and 2012 were reviewed. Charts of bipolar children (n = 49) and children with depressive disorders (n = 58) meeting study inclusion/exclusion criteria were compared on variables assessing clinical characteristics, treatments, and outcomes. Outcomes were assessed by using pre- and post-Clinical Global Impressions (CGI)-Severity and Children's Global Assessment Scale (CGAS) scores, and a CGI-Improvement score ≤2 at final visit determined responder status. Bipolar outcome predictors were assessed by using multiple linear regression. Clinic prevalence rates were 6.9% for early-onset bipolar disorder and 1.5% for very early-onset bipolar disorder. High rates of comorbid diagnoses, symptom severity, parental stress, and child high-risk behaviors were found in both groups. The bipolar cohort had higher rates of aggression and higher lifetime systems of care utilization. The final CGI and CGAS outcomes for unipolar depression patients differed statistically significantly from those for the bipolar cohort, reflecting better clinical status and more improvement at outcome for the depression patients. Both parent-reported Child Behavior Checklist total T-score at clinic admission and the number of lifetime systems-of-care for the child were significantly and inversely associated with improvement for the bipolar cohort. Early-onset bipolar disorder is a complex and heterogeneous psychiatric disorder. Evidence-based treatment should emphasize psychopharmacology with adjunctive family and individual psychotherapy. Strategies to improve engagement in treatment may be especially important. Given high rates of high-risk behaviors in these youth, regular mental health follow-up to assess safety is important. Additional evidence-based treatments for pediatric bipolar disorder are needed.

Sex and Gender Differences in the Outcomes of Vaccination over the Life Course.

PubMed

Flanagan, Katie L; Fink, Ashley L; Plebanski, Magdalena; Klein, Sabra L

2017-10-06

Both sex (i.e., biological differences) and gender (i.e., social or cultural influences) impact vaccine acceptance, responses, and outcomes. Clinical data illustrate that among children, young adults, and aged individuals, males and females differ in vaccine-induced immune responses, adverse events, and protection. Although males are more likely to receive vaccines, following vaccination, females typically develop higher antibody responses and report more adverse effects of vaccination than do males. Human, nonhuman animal, and in vitro studies reveal numerous immunological, genetic, hormonal, and environmental factors that differ between males and females and contribute to sex- and gender-specific vaccine responses and outcomes. Herein, we address the impact of sex and gender variables that should be considered in preclinical and clinical studies of vaccines.

False-Positive Rate of AKI Using Consensus Creatinine–Based Criteria

PubMed Central

Lin, Jennie; Fernandez, Hilda; Shashaty, Michael G.S.; Negoianu, Dan; Testani, Jeffrey M.; Berns, Jeffrey S.; Parikh, Chirag R.

2015-01-01

Background and objectives Use of small changes in serum creatinine to diagnose AKI allows for earlier detection but may increase diagnostic false–positive rates because of inherent laboratory and biologic variabilities of creatinine. Design, setting, participants, & measurements We examined serum creatinine measurement characteristics in a prospective observational clinical reference cohort of 2267 adult patients with AKI by Kidney Disease Improving Global Outcomes creatinine criteria and used these data to create a simulation cohort to model AKI false–positive rates. We simulated up to seven successive blood draws on an equal population of hypothetical patients with unchanging true serum creatinine values. Error terms generated from laboratory and biologic variabilities were added to each simulated patient’s true serum creatinine value to obtain the simulated measured serum creatinine for each blood draw. We determined the proportion of patients who would be erroneously diagnosed with AKI by Kidney Disease Improving Global Outcomes creatinine criteria. Results Within the clinical cohort, 75.0% of patients received four serum creatinine draws within at least one 48-hour period during hospitalization. After four simulated creatinine measurements that accounted for laboratory variability calculated from assay characteristics and 4.4% of biologic variability determined from the clinical cohort and publicly available data, the overall false–positive rate for AKI diagnosis was 8.0% (interquartile range =7.9%–8.1%), whereas patients with true serum creatinine ≥1.5 mg/dl (representing 21% of the clinical cohort) had a false–positive AKI diagnosis rate of 30.5% (interquartile range =30.1%–30.9%) versus 2.0% (interquartile range =1.9%–2.1%) in patients with true serum creatinine values <1.5 mg/dl (P<0.001). Conclusions Use of small serum creatinine changes to diagnose AKI is limited by high false–positive rates caused by inherent variability of serum creatinine at higher baseline values, potentially misclassifying patients with CKD in AKI studies. PMID:26336912

False-Positive Rate of AKI Using Consensus Creatinine-Based Criteria.

PubMed

Lin, Jennie; Fernandez, Hilda; Shashaty, Michael G S; Negoianu, Dan; Testani, Jeffrey M; Berns, Jeffrey S; Parikh, Chirag R; Wilson, F Perry

2015-10-07

Use of small changes in serum creatinine to diagnose AKI allows for earlier detection but may increase diagnostic false-positive rates because of inherent laboratory and biologic variabilities of creatinine. We examined serum creatinine measurement characteristics in a prospective observational clinical reference cohort of 2267 adult patients with AKI by Kidney Disease Improving Global Outcomes creatinine criteria and used these data to create a simulation cohort to model AKI false-positive rates. We simulated up to seven successive blood draws on an equal population of hypothetical patients with unchanging true serum creatinine values. Error terms generated from laboratory and biologic variabilities were added to each simulated patient's true serum creatinine value to obtain the simulated measured serum creatinine for each blood draw. We determined the proportion of patients who would be erroneously diagnosed with AKI by Kidney Disease Improving Global Outcomes creatinine criteria. Within the clinical cohort, 75.0% of patients received four serum creatinine draws within at least one 48-hour period during hospitalization. After four simulated creatinine measurements that accounted for laboratory variability calculated from assay characteristics and 4.4% of biologic variability determined from the clinical cohort and publicly available data, the overall false-positive rate for AKI diagnosis was 8.0% (interquartile range =7.9%-8.1%), whereas patients with true serum creatinine ≥1.5 mg/dl (representing 21% of the clinical cohort) had a false-positive AKI diagnosis rate of 30.5% (interquartile range =30.1%-30.9%) versus 2.0% (interquartile range =1.9%-2.1%) in patients with true serum creatinine values <1.5 mg/dl (P<0.001). Use of small serum creatinine changes to diagnose AKI is limited by high false-positive rates caused by inherent variability of serum creatinine at higher baseline values, potentially misclassifying patients with CKD in AKI studies. Copyright © 2015 by the American Society of Nephrology.

High Intrapatient Variability of Tacrolimus Levels and Outpatient Clinic Nonattendance Are Associated With Inferior Outcomes in Renal Transplant Patients

PubMed Central

Goodall, Dawn L.; Willicombe, Michelle; McLean, Adam G.; Taube, David

2017-01-01

Background Nonadherence to immunosuppressants is associated with rejection and allograft loss. Intrapatient variability (IPV) of immunosuppression levels is a marker of nonadherence. This study describes the impact of IPV of tacrolimus levels in patients receiving a tacrolimus monotherapy immunosuppression protocol. Methods We retrospectively analyzed the outpatient tacrolimus levels of kidney-only transplant patients taken between 6 and 12 months posttransplant. IPV was determined using the coefficient of variance. Results Six hundred twenty-eight patients with a mean number of 8.98 ± 3.81 tacrolimus levels and a mean follow-up of 4.72 ± 2.19 years were included. Multivariate analysis showed death was associated with increasing age (1.04 [1.01-1.07], P = 0.0055), diabetes at time of transplant (2.79 [1.44-5.41], P = 0.0024), and rejection (2.34 [1.06-5.19], P = 0.036). Variables associated with graft loss included the highest variability group (2.51 [1.01-6.27], P = 0.048), mean tacrolimus level less than 5 ng/mL (4.32 [1.94-9.63], P = 0.0003), a high clinic nonattendance rate (1.10 [1.01-1.20], P = 0.03), and rejection (9.83 [4.62-20.94], P < 0.0001). Independent risk factors for rejection were de novo donor-specific antibody (3.15 [1.84-5.39], P < 0.0001), mean tacrolimus level less than 5 ng/mL (2.57 [1.27-5.19], P = 0.00860, and a high clinic nonattendance rate (1.11 [1.05-1.18], P = 0.0005). Conclusions This study shows that high tacrolimus IPV and clinic nonattendance are associated with inferior allograft survival. Interventions to minimize the causes of high variability, particularly nonadherence are essential to improve long-term allograft outcomes. PMID:28795143

Patients with HIV/Aids and ulcer risk: nursing care demands.

PubMed

Pereira, Lanara Alves; Feitosa, Manuella Carvalho; Silva, Grazielle Roberta Freitas da; Leite, Illoma Rossany Lima; Silva, Maria Esther; Soares, Rômulo Diego Monte

2016-06-01

to analyze the demand for nursing care and the risk of pressure ulcers (PU) of patients with HIV/Aids. quantitative survey, carried out from December 2012 to March 2013 in a public hospital of Teresina, state of Piauí, Brazil. the sample of 31 patients was predominantly male, mean age 36.6 years, average care demand 49.4%, most showing some risk of developing PU. The variables correlated with PU risk were care demand and clinical outcome (death). Those associated with care demand were age and clinical outcome (death). the results showed that patients require moderate nursing care needs and most of them present risk of developing PU.

Scarring of Soft Tissues Following Apical Surgery: Visual Assessment of Outcomes One Year After Intervention Using the Bern and Manchester Scores.

PubMed

von Arx, Thomas; Janner, Simone Fm; Hänni, Stefan; Bornstein, Michael M

The successful outcome of apical surgery is usually defined by absence of clinical signs and symptoms and resolution of previous periapical radiolucencies. However, little attention is given to soft tissue scarring. The present study evaluated the severity of gingival and mucosal scarring 1 year following apical surgery of 52 teeth. Clinical pictures taken at the 1-year examination were rated by three observers using specific scarring scores. The overall repeatability of the two scores was high (85.3%), whereas the overall reproducibility was relatively low (44.2%). None of the tested variables proved significant for influencing scar severity.

US-guided percutaneous cholecystostomy: features predicting culture-positive bile and clinical outcome.

PubMed

Sosna, Jacob; Kruskal, Jonathan B; Copel, Laurian; Goldberg, S Nahum; Kane, Robert A

2004-03-01

To assess sonographic and clinical features that might be used to predict infected bile and/or patient outcome from ultrasonography (US)-guided percutaneous cholecystostomy. Between February 1997 and August 2002 at one institution, 112 patients underwent US-guided percutaneous cholecystostomy (59 men, 53 women; average age, 69.3 years). All US images were scored on a defined semiquantitative scale according to preset parameters: (a) gallbladder distention, (b) sludge and/or stones, (c) wall appearance, (d) pericholecystic fluid, and (e) common bile duct size and/or choledocholithiasis. Separate and total scores were generated. Retrospective evaluation of (a) the bacteriologic growth of aspirated bile and its color and (b) clinical indices (fever, white blood cell count, bilirubin level, liver function test results) was conducted by reviewing medical records. For each patient, the clinical manifestation was classified into four groups: (a) localized right upper quadrant symptoms, (b) generalized abdominal symptoms, (c) unexplained sepsis, or (d) sepsis with other known infection. Logistic regression models, exact Wilcoxon-Mann-Whitney test, and the Kruskal-Wallis test were used. Forty-seven (44%) of 107 patients had infected bile. A logistic regression model showed that wall appearance, distention, bile color, and pericholecystic fluid were not individually significant predictors for culture-positive bile, leaving sludge and/or stones (P =.003, odds ratio = 1.647), common bile duct status (P =.02, odds ratio = 2.214), and total score (P =.007, odds ratio = 1.267). No US covariates or clinical indices predicted clinical outcome. Clinical manifestation was predictive of clinical outcome (P =.001) and aspirating culture-positive bile (P =.008); specifically, 30 (86%) of 35 patients with right upper quadrant symptoms had their condition improve, compared with one (7%) of 15 asymptomatic patients with other known causes of infection. US variables can be used to predict culture-positive bile but not patient outcome. Clinical manifestation is important because patients with right upper quadrant symptoms have the best clinical outcome. Copyright RSNA, 2004

Exposure and response prevention process predicts treatment outcome in youth with OCD.

PubMed

Kircanski, Katharina; Peris, Tara S

2015-04-01

Recent research on the treatment of adults with anxiety disorders suggests that aspects of the in-session exposure therapy process are relevant to clinical outcomes. However, few comprehensive studies have been conducted with children and adolescents. In the present study, 35 youth diagnosed with primary obsessive-compulsive disorder (OCD; M age = 12.9 years, 49% male, 63% Caucasian) completed 12 sessions of exposure and response prevention (ERP) in one of two treatment conditions as part of a pilot randomized controlled testing of a family focused intervention for OCD. Key exposure process variables, including youth self-reported distress during ERP and the quantity and quality of ERP completed, were computed. These variables were examined as predictors of treatment outcomes assessed at mid-treatment, post-treatment, and three-month follow-up, partialing treatment condition. In general, greater variability of distress during ERP and completing a greater proportion of combined exposures (i.e., exposures targeting more than one OC symptom at once) were predictive of better outcomes. Conversely, greater distress at the end of treatment was generally predictive of poorer outcomes. Finally, several variables, including within- and between-session decreases in distress during ERP, were not consistently predictive of outcomes. Findings signal potentially important facets of exposure for youth with OCD and have implications for treatment. A number of results also parallel recent findings in the adult literature, suggesting that there may be some continuity in exposure processes from child to adult development. Future work should examine additional measures of exposure process, such as psychophysiological arousal during exposure, in youth.

Measuring the health effects of gender.

PubMed

Phillips, S P

2008-04-01

The health effects of gender are mediated via group-level constraints of sex roles and norms, discrimination and marginalisation of individuals, and internalisation of the stresses of role discordance. Although gender is frequently a lens through which data are interpreted there are few composite measures that insert gender as an independent variable into research design. Instead, sex disaggregation of data is often conflated with gender, identifying statistically significant but sometimes clinically insignificant sex differences. To directly assess the impact of gender on wellbeing requires development of group and individual-level derived variables. At the ecological level such a summative variable could be composed of a selection of group-level measures of equality between sexes. This gender index could be used in ecological and individual-level studies of health outcomes. A quantitative indicator of gender role acceptance and of the personal effects of gender inequities could insert the often hidden variable of gender into individual-level clinical research.

Risk factors for poor outcomes in patients with open-globe injuries

PubMed Central

Page, Rita D; Gupta, Sumeet K; Jenkins, Thomas L; Karcioglu, Zeynel A

2016-01-01

Purpose The aim of this study was to identify the risk factors that are predictive of poor outcomes in penetrating globe trauma. Patients and methods This retrospective case series evaluated 103 eyes that had been surgically treated for an open-globe injury from 2007 to 2010 at the eye clinic of the University of Virginia. A total of 64 eyes with complete medical records and at least 6 months of follow-up were included in the study. Four risk factors (preoperative best-corrected visual acuity [pre-op BCVA], ocular trauma score [OTS], zone of injury [ZOI], and time lapse [TL] between injury and primary repair) and three outcomes (final BCVA, monthly rate of additional surgeries [MRAS], and enucleation) were identified for analysis. Results Pre-op BCVA was positively associated with MRAS, final BCVA, and enucleation. Calculated OTS was negatively associated with the outcome variables. No association was found between TL and ZOI with the outcome variables. Further, age and predictor variable-adjusted analyses showed pre-op BCVA to be independently positively associated with MRAS (P=0.008) and with final BCVA (P<0.001), while the calculated OTS was independently negatively associated with final BCVA (P<0.001), but not uniquely associated with MRAS (P=0.530). Conclusion Pre-op BCVA and OTS are best correlated with prognosis in open-globe injuries. However, no conventional features reliably predict the outcome of traumatized eyes. PMID:27536059

Risk adjustment for comparing hospital quality with surgery: how many variables are needed?

PubMed

Dimick, Justin B; Osborne, Nicholas H; Hall, Bruce L; Ko, Clifford Y; Birkmeyer, John D

2010-04-01

The American College of Surgeons' National Surgical Quality Improvement Program (ACS NSQIP) will soon be reporting procedure-specific outcomes, and hopes to reduce the burden of data collection by collecting fewer variables. We sought to determine whether these changes threaten the robustness of the risk adjustment of hospital quality comparisons. We used prospective, clinical data from the ACS NSQIP from 2005 to 2007 (184 hospitals, 74,887 patients). For the 5 general surgery operations in the procedure-specific NSQIP, we compared the ability of the full model (21 variables), an intermediate model (12 variables), and a limited model (5 variables) to predict patient outcomes and to risk-adjust hospital outcomes. The intermediate and limited models were comparable with the full model in all analyses. In the assessment of patient risk, the limited and full models had very similar discrimination at the patient level (C-indices for all 5 procedures combined of 0.93 versus 0.91 for mortality and 0.78 versus 0.76 for morbidity) and showed good calibration across strata of patient risk. In assessing hospital-specific outcomes, results from the limited and full-risk models were highly correlated for both mortality (range 0.94 to 0.99 across the 5 operations) and morbidity (range 0.96 to 0.99). Procedure-specific hospital quality measures can be adequately risk-adjusted with a limited number of variables. In the context of the ACS NSQIP, moving to a more limited model will dramatically reduce the burden of data collection for participating hospitals. Published by Elsevier Inc.

One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial.

PubMed

Lulic, Martina; Leiggener Görög, Isabelle; Salvi, Giovanni E; Ramseier, Christoph A; Mattheos, Nikolaos; Lang, Niklaus P

2009-08-01

Single photodynamic therapy (PDT) has been effective in initial periodontal therapy, but only improved bleeding on probing (BoP) in maintenance patients after a single use. Repeated PDT has not been addressed. To study the possible added benefits of repeated adjunctive PDT to conventional treatment of residual pockets in patients enrolled in periodontal maintenance. Ten maintenance patients with 70 residual pockets [probing pocket depth (PPD)>or=5 mm] were randomly assigned for treatment five times in 2 weeks (Days 0, 1, 2, 7, 14) with PDT (test) or non-activated laser (control) following debridement. The primary outcome variable was PPD, and the secondary variables were clinical attachment level (CAL) and BoP. These were assessed at 3, 6 and 12 months following the interventions. Greater PPD reductions were observed in the test (-0.67 +/- 0.34; p=0.01) compared with the control patients (-0.04 +/- 0.33; NS) after 6 months. Significant CAL gain (+0.52 +/- 0.31; p=0.01) was noted for the test, but not in the control (-0.27 +/- 0.52; NS) patients after 6 months. BoP percentages decreased significantly in test (97-64%, 67%, 77%), but not control patients after 3, 6 and 12 months. Repeated (five times) PDT adjunctive to debridement yielded improved clinical outcomes in residual pockets in maintenance patients. The effects were best documented after 6 months.

"Utstein style" spreadsheet and database programs based on Microsoft Excel and Microsoft Access software for CPR data management of in-hospital resuscitation.

PubMed

Adams, Bruce D; Whitlock, Warren L

2004-04-01

In 1997, The American Heart Association in association with representatives of the International Committee on Resuscitation (ILCOR) published recommended guidelines for reviewing, reporting and conducting in-hospital cardiopulmonary resuscitation (CPR) outcomes using the "Utstein style". Using these guidelines, we developed two Microsoft Office based database management programs that may be useful to the resuscitation community. We developed a user-friendly spreadsheet based on MS Office Excel. The user enters patient variables such as name, age, and diagnosis. Then, event resuscitation variables such as time of collapse and CPR team arrival are entered from a "code flow sheet". Finally, outcome variables such as patient condition at different time points are recorded. The program then makes automatic calculations of average response times, survival rates and other important outcome measurements. Also using the Utstein style, we developed a database program based on MS Office Access. To promote free public access to these programs, we established at a website. These programs will help hospitals track, analyze, and present their CPR outcomes data. Clinical CPR researchers might also find the programs useful because they are easily modified and have statistical functions.

Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: methods of a decision-maker-researcher partnership systematic review.

PubMed

Haynes, R Brian; Wilczynski, Nancy L

2010-02-05

Computerized clinical decision support systems are information technology-based systems designed to improve clinical decision-making. As with any healthcare intervention with claims to improve process of care or patient outcomes, decision support systems should be rigorously evaluated before widespread dissemination into clinical practice. Engaging healthcare providers and managers in the review process may facilitate knowledge translation and uptake. The objective of this research was to form a partnership of healthcare providers, managers, and researchers to review randomized controlled trials assessing the effects of computerized decision support for six clinical application areas: primary preventive care, therapeutic drug monitoring and dosing, drug prescribing, chronic disease management, diagnostic test ordering and interpretation, and acute care management; and to identify study characteristics that predict benefit. The review was undertaken by the Health Information Research Unit, McMaster University, in partnership with Hamilton Health Sciences, the Hamilton, Niagara, Haldimand, and Brant Local Health Integration Network, and pertinent healthcare service teams. Following agreement on information needs and interests with decision-makers, our earlier systematic review was updated by searching Medline, EMBASE, EBM Review databases, and Inspec, and reviewing reference lists through 6 January 2010. Data extraction items were expanded according to input from decision-makers. Authors of primary studies were contacted to confirm data and to provide additional information. Eligible trials were organized according to clinical area of application. We included randomized controlled trials that evaluated the effect on practitioner performance or patient outcomes of patient care provided with a computerized clinical decision support system compared with patient care without such a system. Data will be summarized using descriptive summary measures, including proportions for categorical variables and means for continuous variables. Univariable and multivariable logistic regression models will be used to investigate associations between outcomes of interest and study specific covariates. When reporting results from individual studies, we will cite the measures of association and p-values reported in the studies. If appropriate for groups of studies with similar features, we will conduct meta-analyses. A decision-maker-researcher partnership provides a model for systematic reviews that may foster knowledge translation and uptake.

Effectiveness of physical therapy for patients with neck pain: an individualized approach using a clinical decision-making algorithm.

PubMed

Wang, Wendy T J; Olson, Sharon L; Campbell, Anne H; Hanten, William P; Gleeson, Peggy B

2003-03-01

The purpose of this study was to determine the effectiveness of an individualized physical therapy intervention in treating neck pain based on a clinical reasoning algorithm. Treatment effectiveness was examined by assessing changes in impairment, physical performance, and disability in response to intervention. One treatment group of 30 patients with neck pain completed physical therapy treatment. The control group of convenience was formed by a cohort group of 27 subjects who also had neck pain but did not receive treatment for various reasons. There were no significant differences between groups in demographic data and the initial test scores of the outcome measures. A quasi-experimental, nonequivalent, pretest-posttest control group design was used. A physical therapist rendered an eclectic intervention to the treatment group based on a clinical decision-making algorithm. Treatment outcome measures included the following five dependent variables: cervical range of motion, numeric pain rating, timed weighted overhead endurance, the supine capital flexion endurance test, and the Patient Specific Functional Scale. Both the treatment and control groups completed the initial and follow-up examinations, with an average duration of 4 wk between tests. Five mixed analyses of variance with follow-up tests showed a significant difference for all outcome measures in the treatment group compared with the control group. After an average 4 wk of physical therapy intervention, patients in the treatment group demonstrated statistically significant increases of cervical range of motion, decrease of pain, increases of physical performance measures, and decreases in the level of disability. The control group showed no differences in all five outcome variables between the initial and follow-up test scores. This study delineated algorithm-based clinical reasoning strategies for evaluating and treating patients with cervical pain. The algorithm can help clinicians classify patients with cervical pain into clinical patterns and provides pattern-specific guidelines for physical therapy interventions. An organized and specific physical therapy program was effective in improving the status of patients with neck pain.

Clinical outcomes of isolated renal failure compared to other forms of organ failure in patients with severe acute pancreatitis.

PubMed

Gougol, Amir; Dugum, Mohannad; Dudekula, Anwar; Greer, Phil; Slivka, Adam; Whitcomb, David C; Yadav, Dhiraj; Papachristou, Georgios I

2017-08-07

To assess differences in clinical outcomes of isolated renal failure (RF) compared to other forms of organ failure (OF) in patients with severe acute pancreatitis (SAP). Using a prospectively maintained database of patients with acute pancreatitis admitted to a tertiary medical center between 2003 and 2016, those with evidence of persistent OF were classified to renal, respiratory, cardiovascular, or multi-organ (2 or more organs). Data regarding demographics, comorbidities, etiology of acute pancreatitis, and clinical outcomes were prospectively recorded. Differences in clinical outcomes after development of isolated RF in comparison to other forms of OF were determined using independent t and Mann-Whitney U tests for continues variables, and χ 2 test for discrete variables. Among 500 patients with acute pancreatitis, 111 patients developed persistent OF: mean age was 54 years, and 75 (67.6%) were male. Forty-three patients had isolated OF: 17 (15.3%) renal, 25 (21.6%) respiratory, and 1 (0.9%) patient with cardiovascular failure. No differences in demographics, etiology of acute pancreatitis, systemic inflammatory response syndrome scores, or development of pancreatic necrosis were seen between patients with isolated RF vs isolated respiratory failure. Patients with isolated RF were less likely to require nutritional support (76.5% vs 96%, P = 0.001), ICU admission (58.8% vs 100%, P = 0.001), and had shorter mean ICU stay (2.4 d vs 15.7 d, P < 0.001), compared to isolated respiratory failure. None of the patients with isolated RF or isolated respiratory failure died. Among patients with SAP per the Revised Atlanta Classification, approximately 15% develop isolated RF. This subgroup seems to have a less protracted clinical course compared to other forms of OF. Isolated RF might be weighed less than isolated respiratory failure in risk predictive modeling of acute pancreatitis.

Perioperative Near-Infrared Spectroscopy Monitoring in Neonates With Congenital Heart Disease: Relationship of Cerebral Tissue Oxygenation Index Variability With Neurodevelopmental Outcome.

PubMed

Spaeder, Michael C; Klugman, Darren; Skurow-Todd, Kami; Glass, Penny; Jonas, Richard A; Donofrio, Mary T

2017-03-01

To evaluate the value of perioperative cerebral near-infrared spectroscopy monitoring using variability analysis in the prediction of neurodevelopmental outcomes in neonates undergoing surgery for congenital heart disease. Retrospective cohort study. Urban, academic, tertiary-care children's hospital. Neonates undergoing surgery with cardiopulmonary bypass for congenital heart disease. Perioperative monitoring of continuous cerebral tissue oxygenation index by near-infrared spectroscopy and subsequent neurodevelopmental testing at 6, 15, and 21 months of age. We developed a new measure, cerebral tissue oxygenation index variability, using the root mean of successive squared differences of averaged 1-minute cerebral tissue oxygenation index values for both the intraoperative and first 24-hours postoperative phases of monitoring. There were 62 neonates who underwent cerebral tissue oxygenation index monitoring during surgery for congenital heart disease and 44 underwent subsequent neurodevelopmental testing (12 did not survive until testing and six were lost to follow-up). Among the 44 monitored patients who underwent neurodevelopmental testing, 20 (45%) had abnormal neurodevelopmental indices. Patients with abnormal neurodevelopmental indices had lower postoperative cerebral tissue oxygenation index variability when compared with patients with normal indices (p = 0.01). Adjusting for class of congenital heart disease and duration of deep hypothermic circulatory arrest, lower postoperative cerebral tissue oxygenation index variability was associated with poor neurodevelopmental outcome (p = 0.02). We found reduced postoperative cerebral tissue oxygenation index variability in neonatal survivors of congenital heart disease surgery with poor neurodevelopmental outcomes. We hypothesize that reduced cerebral tissue oxygenation index variability may be a surrogate for impaired cerebral metabolic autoregulation in the immediate postoperative period. Further research is needed to investigate clinical implications of this finding and opportunities for using this measure to drive therapeutic interventions.

Diagnostic accuracy and receiver-operating characteristics curve analysis in surgical research and decision making.

PubMed

Søreide, Kjetil; Kørner, Hartwig; Søreide, Jon Arne

2011-01-01

In surgical research, the ability to correctly classify one type of condition or specific outcome from another is of great importance for variables influencing clinical decision making. Receiver-operating characteristic (ROC) curve analysis is a useful tool in assessing the diagnostic accuracy of any variable with a continuous spectrum of results. In order to rule a disease state in or out with a given test, the test results are usually binary, with arbitrarily chosen cut-offs for defining disease versus health, or for grading of disease severity. In the postgenomic era, the translation from bench-to-bedside of biomarkers in various tissues and body fluids requires appropriate tools for analysis. In contrast to predetermining a cut-off value to define disease, the advantages of applying ROC analysis include the ability to test diagnostic accuracy across the entire range of variable scores and test outcomes. In addition, ROC analysis can easily examine visual and statistical comparisons across tests or scores. ROC is also favored because it is thought to be independent from the prevalence of the condition under investigation. ROC analysis is used in various surgical settings and across disciplines, including cancer research, biomarker assessment, imaging evaluation, and assessment of risk scores.With appropriate use, ROC curves may help identify the most appropriate cutoff value for clinical and surgical decision making and avoid confounding effects seen with subjective ratings. ROC curve results should always be put in perspective, because a good classifier does not guarantee the expected clinical outcome. In this review, we discuss the fundamental roles, suggested presentation, potential biases, and interpretation of ROC analysis in surgical research.

Outcome of shunting in idiopathic normal-pressure hydrocephalus and the value of outcome assessment in shunted patients.

PubMed

Klinge, Petra; Marmarou, Anthony; Bergsneider, Marvin; Relkin, Norman; Black, Peter McL

2005-09-01

To develop guidelines for assessing shunt outcome in patients with idiopathic normal-pressure hydrocephalus (INPH). To date, the literature available on this topic has been marked by disparate definitions of clinical improvement, varying postoperative follow-up protocols and periods, and substantial differences in the postoperative management. Because specific criteria for defining clinical improvement are seldom reported, conclusions drawn about shunt outcome may be subjective. A MEDLINE search back to 1966 was undertaken using the query NPH, normal-pressure hydrocephalus, shunting, shunt treatment, shunt response, outcome, and clinical outcome. The criteria for selection were studies that included INPH from 1966 to the present in which the outcome of INPH was reported in patient groups of 20 or more. To date, there is no standard for outcome assessment of shunt treatment in INPH. The variable improvement rates reported are not only because of different criteria for selection of patients but also because of different postoperative assessment procedures and follow-up intervals. Studies that have established fixed protocols for follow-up have shown that short- and long-term periods after shunting are determined by many factors. Whereas short-term results were more likely to be influenced by shunt-associated risks, long-term results were independent of factors inherent to the shunt procedure and shunt complications, i.e., death and morbidity related to concomitant cerebrovascular and vascular diseases. Studies have shown that beyond 1 year after surgery, these factors definitely influence the clinical effect of shunting, making the 1-year postshunt period a potential determinant of the shunt outcome. Guidelines for outcome assessment were developed on the basis of the available evidence and consensus of expert opinion.

A survival tree method for the analysis of discrete event times in clinical and epidemiological studies.

PubMed

Schmid, Matthias; Küchenhoff, Helmut; Hoerauf, Achim; Tutz, Gerhard

2016-02-28

Survival trees are a popular alternative to parametric survival modeling when there are interactions between the predictor variables or when the aim is to stratify patients into prognostic subgroups. A limitation of classical survival tree methodology is that most algorithms for tree construction are designed for continuous outcome variables. Hence, classical methods might not be appropriate if failure time data are measured on a discrete time scale (as is often the case in longitudinal studies where data are collected, e.g., quarterly or yearly). To address this issue, we develop a method for discrete survival tree construction. The proposed technique is based on the result that the likelihood of a discrete survival model is equivalent to the likelihood of a regression model for binary outcome data. Hence, we modify tree construction methods for binary outcomes such that they result in optimized partitions for the estimation of discrete hazard functions. By applying the proposed method to data from a randomized trial in patients with filarial lymphedema, we demonstrate how discrete survival trees can be used to identify clinically relevant patient groups with similar survival behavior. Copyright © 2015 John Wiley & Sons, Ltd.

Training in the implementation of prolonged exposure therapy: provider correlates of treatment outcome.

PubMed

Eftekhari, Afsoon; Crowley, Jill J; Ruzek, Josef I; Garvert, Donn W; Karlin, Bradley E; Rosen, Craig S

2015-02-01

The authors examined the degree to which provider characteristics, such as profession, treatment orientation, prior experience in treating posttraumatic stress disorder (PTSD), prior experience with prolonged exposure (PE) therapy, and attitudes about PE, were related to the clinical outcomes of veterans receiving care from clinicians participating in the national Department of Veterans Affairs (VA) PE Training Program. Positive patient outcomes were achieved by providers of every profession, theoretical orientation, level of clinical experience treating PTSD, and prior PE training experience. With 1,105 providers and 32 predictors (13 provider variables), power was at least 90% power to detect an effect of β = .15. Profession was the only provider characteristic significantly related to outcomes, but the mean effect (a 2 point difference on the PTSD Checklist) was too small to be clinically meaningful. The results support the intensive training model used in the VA PE training program and demonstrate that clinicians of varying backgrounds can be trained using interactive training workshops followed by case consultation to deliver PE effectively. Published 2015. This article is a US Government work and is in the public domain in the USA.

Problem-based learning outcomes: the glass half-full.

PubMed

Distlehorst, Linda H; Dawson, Elizabeth; Robbs, Randall S; Barrows, Howard S

2005-03-01

To compare the characteristics and outcome data of students from a single institution with a two-track, problem based learning (PBL) and standard (STND) curriculum. PBL and STND students from nine graduating classes at Southern Illinois University School of Medicine were compared using common medical school performance outcomes (USMLE Step 1, USMLE Step 2, clerkship mean ratings, number of clerkship honors and remediation designations, and the senior clinical competency exam), as well as common admission and demographic variables. PBL students were older, and the cohort had a higher proportion of women. The two tracks had similar USMLE Step 1 and 2 mean scores and pass rates. Performance differences were significant for PBL students in two clerkships as well as in the clerkship subcategories of clinical performance, knowledge and clinical reasoning, and noncognitive behaviors. In addition, the proportion of PBL students earning honors was greater. The traditional undergraduate educational outcomes for the PBL and STND students are very positive. In several of the clerkship performance measures, the PBL students performed significantly better, and in no circumstance did they perform worse than the STND students.

Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients.

PubMed

Chang, Helena C; Tzou, David T; Usawachintachit, Manint; Duty, Brian D; Hsi, Ryan S; Harper, Jonathan D; Sorensen, Mathew D; Stoller, Marshall L; Sur, Roger L; Chi, Thomas

2016-12-01

Registry-based clinical research in nephrolithiasis is critical to advancing quality in urinary stone disease management and ultimately reducing stone recurrence. A need exists to develop Health Insurance Portability and Accountability Act (HIPAA)-compliant registries that comprise integrated electronic health record (EHR) data using prospectively defined variables. An EHR-based standardized patient database-the Registry for Stones of the Kidney and Ureter (ReSKU™)-was developed, and herein we describe our implementation outcomes. Interviews with academic and community endourologists in the United States, Canada, China, and Japan identified demographic, intraoperative, and perioperative variables to populate our registry. Variables were incorporated into a HIPAA-compliant Research Electronic Data Capture database linked to text prompts and registration data within the Epic EHR platform. Specific data collection instruments supporting New patient, Surgery, Postoperative, and Follow-up clinical encounters were created within Epic to facilitate automated data extraction into ReSKU. The number of variables within each instrument includes the following: New patient-60, Surgery-80, Postoperative-64, and Follow-up-64. With manual data entry, the mean times to complete each of the clinic-based instruments were (minutes) as follows: New patient-12.06 ± 2.30, Postoperative-7.18 ± 1.02, and Follow-up-8.10 ± 0.58. These times were significantly reduced with the use of ReSKU structured clinic note templates to the following: New patient-4.09 ± 1.73, Postoperative-1.41 ± 0.41, and Follow-up-0.79 ± 0.38. With automated data extraction from Epic, manual entry is obviated. ReSKU is a longitudinal prospective nephrolithiasis registry that integrates EHR data, lowering the barriers to performing high quality clinical research and quality outcome assessments in urinary stone disease.

Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients

PubMed Central

Chang, Helena C.; Tzou, David T.; Usawachintachit, Manint; Duty, Brian D.; Hsi, Ryan S.; Harper, Jonathan D.; Sorensen, Mathew D.; Stoller, Marshall L.; Sur, Roger L.

2016-01-01

Abstract Objectives: Registry-based clinical research in nephrolithiasis is critical to advancing quality in urinary stone disease management and ultimately reducing stone recurrence. A need exists to develop Health Insurance Portability and Accountability Act (HIPAA)-compliant registries that comprise integrated electronic health record (EHR) data using prospectively defined variables. An EHR-based standardized patient database—the Registry for Stones of the Kidney and Ureter (ReSKU™)—was developed, and herein we describe our implementation outcomes. Materials and Methods: Interviews with academic and community endourologists in the United States, Canada, China, and Japan identified demographic, intraoperative, and perioperative variables to populate our registry. Variables were incorporated into a HIPAA-compliant Research Electronic Data Capture database linked to text prompts and registration data within the Epic EHR platform. Specific data collection instruments supporting New patient, Surgery, Postoperative, and Follow-up clinical encounters were created within Epic to facilitate automated data extraction into ReSKU. Results: The number of variables within each instrument includes the following: New patient—60, Surgery—80, Postoperative—64, and Follow-up—64. With manual data entry, the mean times to complete each of the clinic-based instruments were (minutes) as follows: New patient—12.06 ± 2.30, Postoperative—7.18 ± 1.02, and Follow-up—8.10 ± 0.58. These times were significantly reduced with the use of ReSKU structured clinic note templates to the following: New patient—4.09 ± 1.73, Postoperative—1.41 ± 0.41, and Follow-up—0.79 ± 0.38. With automated data extraction from Epic, manual entry is obviated. Conclusions: ReSKU is a longitudinal prospective nephrolithiasis registry that integrates EHR data, lowering the barriers to performing high quality clinical research and quality outcome assessments in urinary stone disease. PMID:27758162

Non-operative management (NOM) of blunt hepatic trauma: 80 cases.

PubMed

Özoğul, Bünyami; Kısaoğlu, Abdullah; Aydınlı, Bülent; Öztürk, Gürkan; Bayramoğlu, Atıf; Sarıtemur, Murat; Aköz, Ayhan; Bulut, Özgür Hakan; Atamanalp, Sabri Selçuk

2014-03-01

Liver is the most frequently injured organ upon abdominal trauma. We present a group of patients with blunt hepatic trauma who were managed without any invasive diagnostic tools and/or surgical intervention. A total of 80 patients with blunt liver injury who were hospitalized to the general surgery clinic or other clinics due to the concomitant injuries were followed non-operatively. The normally distributed numeric variables were evaluated by Student's t-test or one way analysis of variance, while non-normally distributed variables were analyzed by Mann-Whitney U-test or Kruskal-Wallis variance analysis. Chi-square test was also employed for the comparison of categorical variables. Statistical significance was assumed for p<0.05. There was no significant relationship between patients' Hgb level and liver injury grade, outcome, and mechanism of injury. Also, there was no statistical relationship between liver injury grade, outcome, and mechanism of injury and ALT levels as well as AST level. There was no mortality in any of the patients. During the last quarter of century, changes in the diagnosis and treatment of liver injury were associated with increased survival. NOM of liver injury in patients with stable hemodynamics and hepatic trauma seems to be the gold standard.

Reproducibility of 3D kinematics and surface electromyography measurements of mastication.

PubMed

Remijn, Lianne; Groen, Brenda E; Speyer, Renée; van Limbeek, Jacques; Nijhuis-van der Sanden, Maria W G

2016-03-01

The aim of this study was to determine the measurement reproducibility for a procedure evaluating the mastication process and to estimate the smallest detectable differences of 3D kinematic and surface electromyography (sEMG) variables. Kinematics of mandible movements and sEMG activity of the masticatory muscles were obtained over two sessions with four conditions: two food textures (biscuit and bread) of two sizes (small and large). Twelve healthy adults (mean age 29.1 years) completed the study. The second to the fifth chewing cycle of 5 bites were used for analyses. The reproducibility per outcome variable was calculated with an intraclass correlation coefficient (ICC) and a Bland-Altman analysis was applied to determine the standard error of measurement relative error of measurement and smallest detectable differences of all variables. ICCs ranged from 0.71 to 0.98 for all outcome variables. The outcome variables consisted of four bite and fourteen chewing cycle variables. The relative standard error of measurement of the bite variables was up to 17.3% for 'time-to-swallow', 'time-to-transport' and 'number of chewing cycles', but ranged from 31.5% to 57.0% for 'change of chewing side'. The relative standard error of measurement ranged from 4.1% to 24.7% for chewing cycle variables and was smaller for kinematic variables than sEMG variables. In general, measurements obtained with 3D kinematics and sEMG are reproducible techniques to assess the mastication process. The duration of the chewing cycle and frequency of chewing were the best reproducible measurements. Change of chewing side could not be reproduced. The published measurement error and smallest detectable differences will aid the interpretation of the results of future clinical studies using the same study variables. Copyright © 2015 Elsevier Inc. All rights reserved.

A Movement Monitor Based on Magneto-Inertial Sensors for Non-Ambulant Patients with Duchenne Muscular Dystrophy: A Pilot Study in Controlled Environment.

PubMed

Le Moing, Anne-Gaëlle; Seferian, Andreea Mihaela; Moraux, Amélie; Annoussamy, Mélanie; Dorveaux, Eric; Gasnier, Erwan; Hogrel, Jean-Yves; Voit, Thomas; Vissière, David; Servais, Laurent

2016-01-01

Measurement of muscle strength and activity of upper limbs of non-ambulant patients with neuromuscular diseases is a major challenge. ActiMyo® is an innovative device that uses magneto-inertial sensors to record angular velocities and linear accelerations that can be used over long periods of time in the home environment. The device was designed to insure long-term stability and good signal to noise ratio, even for very weak movements. In order to determine relevant and pertinent clinical variables with potential for use as outcome measures in clinical trials or to guide therapy decisions, we performed a pilot study in non-ambulant neuromuscular patients. We report here data from seven Duchenne Muscular Dystrophy (DMD) patients (mean age 18.5 ± 5.5 years) collected in a clinical setting. Patients were assessed while wearing the device during performance of validated tasks (MoviPlate, Box and Block test and Minnesota test) and tasks mimicking daily living. The ActiMyo® sensors were placed on the wrists during all the tests. Software designed for use with the device computed several variables to qualify and quantify muscular activity in the non-ambulant subjects. Four variables representative of upper limb activity were studied: the rotation rate, the ratio of the vertical component in the overall acceleration, the hand elevation rate, and an estimate of the power of the upper limb. The correlations between clinical data and physical activity and the ActiMyo® movement parameters were analyzed. The mean of the rotation rate and mean of the elevation rate appeared promising since these variables had the best reliability scores and correlations with task scores. Parameters could be computed even in a patient with a Brooke functional score of 6. The variables chosen are good candidates as potential outcome measures in non-ambulant patients with Duchenne Muscular Dystrophy and use of the ActiMyo® is currently being explored in home environment. ClinicalTrials.gov NCT01611597.

Motivation for change as a predictor of treatment response for dysthymia.

PubMed

Frías Ibáñez, Álvaro; González Vallespí, Laura; Palma Sevillano, Carol; Farriols Hernando, Núria

2016-05-01

Dysthymia constitutes a chronic, mild affective disorder characterized by heterogeneous treatment effects. Several predictors of clinical response and attendance have been postulated, although research on the role of the psychological variables involved in this mental disorder is still scarce. Fifty-four adult patients, who met criteria for dysthymia completed an ongoing naturalistic treatment based on the brief interpersonal psychotherapy (IPT-B), which was delivered bimonthly over 16 months. As potential predictor variables, the therapeutic alliance, coping strategies, perceived self-efficacy, and motivation for change were measured at baseline. Outcome variables were response to treatment (Clinical Global Impression and Beck’s Depression Inventory) and treatment attendance. Stepwise multiple linear regression analyses revealed that higher motivation for change predicted better response to treatment. Moreover, higher motivation for change also predicted treatment attendance. Therapeutic alliance was not a predictor variable of neither clinical response nor treatment attendance. These preliminary findings support the adjunctive use of motivational interviewing (MI) techniques in the treatment of dysthymia. Further research with larger sample size and follow-up assessment is warranted.

[A PhD completed 1. Immediate dental implant placement in the aesthetic zone].

PubMed

Slagter, K W

2016-05-01

When aesthetics play a role in an extraction, the tendency is to place an implant in the extraction socket immediately, preferably in combination with a temporary crown. This tendency is probably related to evolving social factors: demanding patients who want an instant and attactive result. In 2 randomised clinical trials (total 80 patients) the results of clinical treatment involving immediate implants in the aesthetic zone are investigated. Depending on the size of the bone defect (< 5 or ≥ 5 mm) the number of surgical interventions was reduced from 2 to 1 or from 3 to 2. The treatment result was measured by the following outcome variables: survival rate, changes in hard and soft -peri-implant tissues, aesthetic indecees and patient-satisfaction. The most important conclusion is that immediate placements of implants in the aesthetic zone, results in -outstanding short-term (1-year) results with respect to the outcome variables. If this also leads to good long-term results has yet to be investigated.

Clinical Outcome Following Radiofrequency Denervation for Refractory Sacroiliac Joint Dysfunction Using the Simplicity III Probe: A 12-Month Retrospective Evaluation.

PubMed

Hegarty, Dominic

2016-01-01

Sacroiliac joint syndrome (SIJ) is diagnosed in 10% to 25% of cases of lower back pain. The response to traditional radiofrequency (RF) denervation of the SIJ has being inconsistent. The Simplicity III RF probe (Neruotherm. Inc.) offers a novel treatment option. To evaluate the long-term clinical outcome (12 months) refractory SIJ syndrome in terms of pain intensity and functional improvement. A 50% reduction in intensity pain intensity (VAS) at 12 months was deemed clinically significant. A 12-month retrospective observational evaluation all of adults treated with RF for refractory SIJ. Chronic pain management center. The medical records of all adults treated with this technique was retrospectively reviewed. The primary outcome was pain intensity scores (VAS) over a 12 months period; Secondary outcomes included Roland-Morris Functional scores (RMF), Brief Pain Inventory (BPI), general health assessment (Sf12), and patient satisfaction scores (GPI), which were recorded pre and post denervation. Pain Intensity improved by 4.7 points compared to pre-treatment representing a 61% reduction in pain at 12 months (n=11, P < 0.001). Significant improvements in (a) RMF (P < 0.01, W2 = 0.63 (large effect size); (b) BPI (P < 0.001, W2 = 0.72 (strong effect size); and (c) Sf12 (P < 0.01) were noted. Overall patients were satisfied with the outcome (GPI = 77.7%). The retrospective in nature of the study and the small sample size are limitations. As it was our policy to monitor the progress of the individuals since the introduction of this technique a reliable method of recording the baseline and outcome variables at each point of contact was in place. Access to a complete set of variables in all individuals over a 12-month period was therefore possible, which we feel contributes to the quality of the dataset. By creating a consistent radiofrequency lesion between the sacral foramen and the SIJ will reliably capture the innervation to the SIJ with significant long-term clinical improvement. This technique should be considered earlier in the treatment algorithm of individuals suffering from SIJ symptoms.

Sterilization of granulomas is common in both active and latent tuberculosis despite extensive within-host variability in bacterial killing

PubMed Central

Lin, Philana Ling; Ford, Christopher B.; Coleman, M. Teresa; Myers, Amy J.; Gawande, Richa; Ioerger, Thomas; Sacchettini, James; Fortune, Sarah M.; Flynn, JoAnne L.

2013-01-01

Over 30% of the world’s population is infected with Mycobacterium tuberculosis (Mtb), yet only ~5–10% will develop clinical disease1. Despite considerable effort, we understand little about what distinguishes individuals who progress to active tuberculosis (TB) from those who remain latent for decades. The variable course of disease is recapitulated in cynomolgus macaques infected with Mtb2. Active disease in macaques is defined by clinical, microbiologic and immunologic signs and occurs in ~45% of animals, while the remaining are clinically asymptomatic2,3. Here, we use barcoded Mtb isolates and quantitative measures of culturable and cumulative bacterial burden to show that most lesions are likely founded by a single bacterium and reach similar maximum burdens. Despite common origins, the fate of individual lesions varies substantially within the same host. Strikingly, in active disease, the host sterilizes some lesions even while others progress. Our data suggest that lesional heterogeneity arises, in part, through differential killing of bacteria after the onset of adaptive immunity. Thus, individual lesions follow diverse and overlapping trajectories, suggesting critical responses occur at a lesional level to ultimately determine the clinical outcome of infection. Defining the local factors that dictate outcome will be important in developing effective interventions to prevent active TB. PMID:24336248

Development of a Hospital Outcome Measure Intended for Use With Electronic Health Records: 30-Day Risk-standardized Mortality After Acute Myocardial Infarction.

PubMed

McNamara, Robert L; Wang, Yongfei; Partovian, Chohreh; Montague, Julia; Mody, Purav; Eddy, Elizabeth; Krumholz, Harlan M; Bernheim, Susannah M

2015-09-01

Electronic health records (EHRs) offer the opportunity to transform quality improvement by using clinical data for comparing hospital performance without the burden of chart abstraction. However, current performance measures using EHRs are lacking. With support from the Centers for Medicare & Medicaid Services (CMS), we developed an outcome measure of hospital risk-standardized 30-day mortality rates for patients with acute myocardial infarction for use with EHR data. As no appropriate source of EHR data are currently available, we merged clinical registry data from the Action Registry-Get With The Guidelines with claims data from CMS to develop the risk model (2009 data for development, 2010 data for validation). We selected candidate variables that could be feasibly extracted from current EHRs and do not require changes to standard clinical practice or data collection. We used logistic regression with stepwise selection and bootstrapping simulation for model development. The final risk model included 5 variables available on presentation: age, heart rate, systolic blood pressure, troponin ratio, and creatinine level. The area under the receiver operating characteristic curve was 0.78. Hospital risk-standardized mortality rates ranged from 9.6% to 13.1%, with a median of 10.7%. The odds of mortality for a high-mortality hospital (+1 SD) were 1.37 times those for a low-mortality hospital (-1 SD). This measure represents the first outcome measure endorsed by the National Quality Forum for public reporting of hospital quality based on clinical data in the EHR. By being compatible with current clinical practice and existing EHR systems, this measure is a model for future quality improvement measures.

Clinical outcomes following cryopreservation of blastocysts by vitrification or slow freezing: a population-based cohort study.

PubMed

Li, Z; Wang, Y A; Ledger, W; Edgar, D H; Sullivan, E A

2014-12-01

What are the clinical efficacy and perinatal outcomes following transfer of vitrified blastocysts compared with transfer of fresh or of slow frozen blastocysts? Compared with slow frozen blastocysts, vitrified blastocysts resulted in significantly higher clinical pregnancy and live delivery rates with similar perinatal outcomes at population level. Although vitrification has been reported to be associated with significantly increased post-thaw survival rates compared with slow freezing, there has been a lack of general consensus over which method of cryopreservation (vitrification versus slow freezing) is most appropriate for blastocysts. A population-based cohort of autologous fresh and initiated thaw cycles (a cycle where embryos were thawed with intention to transfer) performed between January 2009 and December 2011 in Australia and New Zealand was evaluated retrospectively. A total of 46 890 fresh blastocyst transfer cycles, 12 852 initiated slow frozen blastocyst thaw cycles and 20 887 initiated vitrified blastocyst warming cycles were included in the data analysis. Pairwise comparisons were made between the vitrified blastocyst group and slow frozen or fresh blastocyst group. A Chi-square test was used for categorical variables and t-test was used for continuous variables. Cox regression was used to examine the pregnancy outcomes (clinical pregnancy rate, miscarriage rate and live delivery rate) and perinatal outcomes (preterm delivery, low birthweight births, small for gestational age (SGA) births, large for gestational age (LGA) births and perinatal mortality) following transfer of fresh, slow frozen and vitrified blastocysts. The 46 890 fresh blastocyst transfers, 11 644 slow frozen blastocyst transfers and 19 978 vitrified blastocyst transfers resulted in 16 845, 2766 and 6537 clinical pregnancies, which led to 13 049, 2065 and 4955 live deliveries, respectively. Compared with slow frozen blastocyst transfer cycles, vitrified blastocyst transfer cycles resulted in a significantly higher clinical pregnancy rate (adjusted relative risk (ARR): 1.47, 95% confidence intervals (CI): 1.39-1.55) and live delivery rate (ARR: 1.41, 95% CI: 1.34-1.49). Compared with singletons born after transfer of fresh blastocysts, singletons born after transfer of vitrified blastocysts were at 14% less risk of being born preterm (ARR: 0.86, 95% CI: 0.77-0.96), 33% less risk of being low birthweight (ARR: 0.67, 95% CI: 0.58-0.78) and 40% less risk of being SGA (ARR: 0.60, 95% CI: 0.53-0.68). A limitation of this population-based study is the lack of information available on clinic-specific cryopreservation protocols and processes for slow freezing-thaw and vitrification-warm of blastocysts and the potential impact on outcomes. This study presents population-based evidence on clinical efficacy and perinatal outcomes associated with transfer of fresh, slow frozen and vitrified blastocysts. Vitrified blastocyst transfer resulted in significantly higher clinical pregnancy and live delivery rates with similar perinatal outcomes compared with slow frozen blastocyst transfer. Comparably better perinatal outcomes were reported for singletons born after transfer of vitrified blastocysts than singletons born after transfer of fresh blastocysts. Elective vitrification could be considered as an alternative embryo transfer strategy to achieve better perinatal outcomes following Assisted Reproduction Technology (ART) treatment. No specific funding was obtained. The authors have no conflicts of interest to declare. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps

PubMed Central

Mentz, Robert J.; Roessig, Lothar; Greenberg, Barry H.; Sato, Naoki; Shinagawa, Kaori; Yeo, Daniel; Kwok, Bernard W.K.; Reyes, Eugenio B.; Krum, Henry; Pieske, Burkert; Greene, Stephen J.; Ambrosy, Andrew P.; Kelly, Jacob P.; Zannad, Faiez; Pitt, Bertram; Lam, Carolyn S.P.

2016-01-01

Heart failure (HF) is a major and increasing global public health problem. In Asia, aging populations and recent increases in cardiovascular risk factors have contributed to a particularly high burden of HF with similarly poor outcomes compared to the rest of the world. Representation of Asians in landmark HF trials has been variable. In addition, HF patients from Asia demonstrate clinical differences from other geographic regions. Thus, the generalizability of some clinical trials results to the Asian population remains uncertain. In this manuscript, we review differences in the HF phenotype, management and outcomes in patients from East and Southeast Asia. We describe lessons learned in Asia from recent HF registries and clinical trial databases and outline strategies to improve the potential for success in future trials. This review is based on discussions between scientists, clinical trialists, industry representatives and regulatory representatives at the CardioVascular Clinical Trialist Asia Forum on July 4, 2014. PMID:27256745

Improving the prognosis of patients with severely decreased glomerular filtration rate (CKD G4+): conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.

PubMed

Eckardt, Kai-Uwe; Bansal, Nisha; Coresh, Josef; Evans, Marie; Grams, Morgan E; Herzog, Charles A; James, Matthew T; Heerspink, Hiddo J L; Pollock, Carol A; Stevens, Paul E; Tamura, Manjula Kurella; Tonelli, Marcello A; Wheeler, David C; Winkelmayer, Wolfgang C; Cheung, Michael; Hemmelgarn, Brenda R

2018-06-01

Patients with severely decreased glomerular filtration rate (GFR) (i.e., chronic kidney disease [CKD] G4+) are at increased risk for kidney failure, cardiovascular disease (CVD) events (including heart failure), and death. However, little is known about the variability of outcomes and optimal therapeutic strategies, including initiation of kidney replacement therapy (KRT). Kidney Disease: Improving Global Outcomes (KDIGO) organized a Controversies Conference with an international expert group in December 2016 to address this gap in knowledge. In collaboration with the CKD Prognosis Consortium (CKD-PC) a global meta-analysis of cohort studies (n = 264,515 individuals with CKD G4+) was conducted to better understand the timing of clinical outcomes in patients with CKD G4+ and risk factors for different outcomes. The results confirmed the prognostic value of traditional CVD risk factors in individuals with severely decreased GFR, although the risk estimates vary for kidney and CVD outcomes. A 2- and 4-year model of the probability and timing of kidney failure requiring KRT was also developed. The implications of these findings for patient management were discussed in the context of published evidence under 4 key themes: management of CKD G4+, diagnostic and therapeutic challenges of heart failure, shared decision-making, and optimization of clinical trials in CKD G4+ patients. Participants concluded that variable prognosis of patients with advanced CKD mandates individualized, risk-based management, factoring in competing risks and patient preferences. Copyright © 2018 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Monitoring disease progression with plasma creatinine in amyotrophic lateral sclerosis clinical trials

PubMed Central

van Eijk, Ruben P A; Eijkemans, Marinus J C; Ferguson, Toby A; Nikolakopoulos, Stavros; Veldink, Jan H; van den Berg, Leonard H

2018-01-01

Objectives Plasma creatinine is a predictor of survival in amyotrophic lateral sclerosis (ALS). It remains, however, to be established whether it can monitor disease progression and serve as surrogate endpoint in clinical trials. Methods We used clinical trial data from three cohorts of clinical trial participants in the LITRA, EMPOWER and PROACT studies. Longitudinal associations between functional decline, muscle strength and survival with plasma creatinine were assessed. Results were translated to trial design in terms of sample size and power. Results A total of 13 564 measurements were obtained for 1241 patients. The variability between patients in rate of decline was lower in plasma creatinine than in ALS functional rating scale–Revised (ALSFRS-R; p<0.001). The average rate of decline was faster in the ALSFRS-R, with less between-patient variability at baseline (p<0.001). Plasma creatinine had strong longitudinal correlations with the ALSFRS-R (0.43 (0.39–0.46), p<0.001), muscle strength (0.55 (0.51–0.58), p<0.001) and overall mortality (HR 0.88 (0.86–0.91, p<0.001)). Using plasma creatinine as outcome could reduce the sample size in trials by 21.5% at 18 months. For trials up to 10 months, the ALSFRS-R required a lower sample size. Conclusions Plasma creatinine is an inexpensive and easily accessible biomarker that exhibits less variability between patients with ALS over time and is predictive for the patient’s functional status, muscle strength and mortality risk. Plasma creatinine may, therefore, increase the power to detect treatment effects and could be incorporated in future ALS clinical trials as potential surrogate outcome. PMID:29084868

Sexual health clinics for women led by specialist nurses or senior house officers in a central London GUM service: a randomised controlled trial.

PubMed

Miles, K; Penny, N; Mercey, D; Power, R

2002-04-01

To assess the care process and clinical outcomes for two different models of GUM clinic for women: one led by specialist nurses and the other by senior house officers (SHOs). An open randomised controlled trial was carried out in a central London genitourinary medicine (GUM) women's clinic. Of 1172 women telephoning for an appointment, 880 were randomised to provide 169 eligible patients in the specialist nurse arm and 178 in the SHO arm. Of the eligible patients a total of 224 attended their appointment. The clinical records of the randomised women were audited for adequacy of care according to local guidelines. 30 key variables were objectively assessed and recorded on a standard audit form. An overall unitary index score (%) was calculated for each patient. The main variables associated with the outcome of specialist nurse and SHO decision making (diagnostic test request, preliminary diagnosis, and treatment provided) were then analysed independently. The median documentation audit scores for specialist nurses (n=103) and SHOs (n=121) were 92% and 85% respectively (p<0.0001). The specialist nurses' documentation was significantly (p<0.05) more complete than the SHOs' for five variables: details of menstrual cycle, physical examination, medication instructions given to patients, health promotion discussion, and provision of condoms. Specialist nurses performed equally to the SHOs with regard to requesting the correct diagnostic tests, providing the correct preliminary diagnosis, and providing the correct treatment. A model of care using trained GUM nurses working within agreed protocols can provide comprehensive patient care for female patients that is equal to care provided by SHOs. Our results raise important issues regarding advanced GUM nursing education and training, protocol development, and accountability.

Improving patient outcomes in fibrous dysplasia/McCune-Albright syndrome: an international multidisciplinary workshop to inform an international partnership.

PubMed

Boyce, A M; Turner, A; Watts, L; Forestier-Zhang, L; Underhill, A; Pinedo-Villanueva, R; Monsell, F; Tessaris, D; Burren, C; Masi, L; Hamdy, N; Brandi, M L; Chapurlat, R; Collins, M T; Javaid, Muhammad Kassim

2017-12-01

To develop consensus on improving the management of patients, we convened an international workshop involving patients, clinicians, and researchers. Key findings included the diagnostic delay and variability in subsequent management with agreement to develop an international natural history study. We now invite other stakeholders to join the partnership. The aim of this study was develop a consensus on how to improve the management of patients with fibrous dysplasia and prioritize areas for research METHODS: An international workshop was held over 3 days involving patients, clinicians, and researchers. Each day had a combination of formal presentations and facilitated discussions that focused on clinical pathways and research. The patient workshop day highlighted the variability of patients' experience in getting a diagnosis, the knowledge of general clinical staff, and understanding long-term outcomes. The research workshop prioritized collaborations that improved understanding of the contemporary natural history of fibrous dysplasia/McCune-Albright syndrome (FD/MAS). The clinical workshop outlined the key issues around diagnostics, assessment of severity, treatment and monitoring of patients. In spite of advances in understanding the genetic and molecular underpinnings of fibrous dysplasia/McCune-Albright syndrome, clinical management remains a challenge. From the workshop, a consensus was reached to create an international, multi-stakeholder partnership to advance research and clinical care in FD/MAS. We invite other stakeholders to join the partnership.

Cerebrospinal Fluid Biomarkers and Reserve Variables as Predictors of Future "Non-Cognitive" Outcomes of Alzheimer's Disease.

PubMed

Ingber, Adam P; Hassenstab, Jason; Fagan, Anne M; Benzinger, Tammie L S; Grant, Elizabeth A; Holtzman, David M; Morris, John C; Roe, Catherine M

2016-01-01

The influence of reserve variables and Alzheimer's disease (AD) biomarkers on cognitive test performance has been fairly well-characterized. However, less is known about the influence of these factors on "non-cognitive" outcomes, including functional abilities and mood. We examined whether cognitive and brain reserve variables mediate how AD biomarker levels in cognitively normal persons predict future changes in function, mood, and neuropsychiatric behavior. Non-cognitive outcomes were examined in 328 individuals 50 years and older enrolled in ongoing studies of aging and dementia at the Knight Alzheimer Disease Research Center (ADRC). All participants were cognitively normal at baseline (Clinical Dementia Rating [CDR] 0), completed cerebrospinal fluid (CSF) and structural neuroimaging studies within one year of baseline, and were followed for an average of 4.6 annual visits. Linear mixed effects models explored how cognitive reserve and brain reserve variables mediate the relationships between AD biomarker levels and changes in function, mood, and neuropsychiatric behavior in cognitively normal participants. Education levels did not have a significant effect on predicting non-cognitive decline. However, participants with smaller brain volumes exhibited the worst outcomes on measures of mood, functional abilities, and behavioral disturbance. This effect was most pronounced in individuals who also had abnormal CSF biomarkers. The findings suggest that brain reserve plays a stronger, or earlier, role than cognitive reserve in protecting against non-cognitive impairment in AD.

Hearing impairment, cognition and speech understanding: exploratory factor analyses of a comprehensive test battery for a group of hearing aid users, the n200 study

PubMed Central

Rönnberg, Jerker; Lunner, Thomas; Ng, Elaine Hoi Ning; Lidestam, Björn; Zekveld, Adriana Agatha; Sörqvist, Patrik; Lyxell, Björn; Träff, Ulf; Yumba, Wycliffe; Classon, Elisabet; Hällgren, Mathias; Larsby, Birgitta; Signoret, Carine; Pichora-Fuller, M. Kathleen; Rudner, Mary; Danielsson, Henrik; Stenfelt, Stefan

2016-01-01

Abstract Objective: The aims of the current n200 study were to assess the structural relations between three classes of test variables (i.e. HEARING, COGNITION and aided speech-in-noise OUTCOMES) and to describe the theoretical implications of these relations for the Ease of Language Understanding (ELU) model. Study sample: Participants were 200 hard-of-hearing hearing-aid users, with a mean age of 60.8 years. Forty-three percent were females and the mean hearing threshold in the better ear was 37.4 dB HL. Design: LEVEL1 factor analyses extracted one factor per test and/or cognitive function based on a priori conceptualizations. The more abstract LEVEL 2 factor analyses were performed separately for the three classes of test variables. Results: The HEARING test variables resulted in two LEVEL 2 factors, which we labelled SENSITIVITY and TEMPORAL FINE STRUCTURE; the COGNITIVE variables in one COGNITION factor only, and OUTCOMES in two factors, NO CONTEXT and CONTEXT. COGNITION predicted the NO CONTEXT factor to a stronger extent than the CONTEXT outcome factor. TEMPORAL FINE STRUCTURE and SENSITIVITY were associated with COGNITION and all three contributed significantly and independently to especially the NO CONTEXT outcome scores (R2 = 0.40). Conclusions: All LEVEL 2 factors are important theoretically as well as for clinical assessment. PMID:27589015

Hearing impairment, cognition and speech understanding: exploratory factor analyses of a comprehensive test battery for a group of hearing aid users, the n200 study.

PubMed

Rönnberg, Jerker; Lunner, Thomas; Ng, Elaine Hoi Ning; Lidestam, Björn; Zekveld, Adriana Agatha; Sörqvist, Patrik; Lyxell, Björn; Träff, Ulf; Yumba, Wycliffe; Classon, Elisabet; Hällgren, Mathias; Larsby, Birgitta; Signoret, Carine; Pichora-Fuller, M Kathleen; Rudner, Mary; Danielsson, Henrik; Stenfelt, Stefan

2016-11-01

The aims of the current n200 study were to assess the structural relations between three classes of test variables (i.e. HEARING, COGNITION and aided speech-in-noise OUTCOMES) and to describe the theoretical implications of these relations for the Ease of Language Understanding (ELU) model. Participants were 200 hard-of-hearing hearing-aid users, with a mean age of 60.8 years. Forty-three percent were females and the mean hearing threshold in the better ear was 37.4 dB HL. LEVEL1 factor analyses extracted one factor per test and/or cognitive function based on a priori conceptualizations. The more abstract LEVEL 2 factor analyses were performed separately for the three classes of test variables. The HEARING test variables resulted in two LEVEL 2 factors, which we labelled SENSITIVITY and TEMPORAL FINE STRUCTURE; the COGNITIVE variables in one COGNITION factor only, and OUTCOMES in two factors, NO CONTEXT and CONTEXT. COGNITION predicted the NO CONTEXT factor to a stronger extent than the CONTEXT outcome factor. TEMPORAL FINE STRUCTURE and SENSITIVITY were associated with COGNITION and all three contributed significantly and independently to especially the NO CONTEXT outcome scores (R(2) = 0.40). All LEVEL 2 factors are important theoretically as well as for clinical assessment.

Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry): Observational and Retrospective Study.

PubMed

Tehrani, Behnam; Truesdell, Alexander; Singh, Ramesh; Murphy, Charles; Saulino, Patricia

2018-06-28

The development and implementation of a Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided management and improvement of outcomes in cardiogenic shock. The objectives of this study are (1) to collect retrospective clinical outcomes for acute decompensated heart failure cardiogenic shock and acute myocardial infarction cardiogenic shock, and compare current versus historical survival rates and clinical outcomes; (2) to evaluate Inova Heart and Vascular Institute site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017; (3) to compare outcomes related to early implementation of mechanical circulatory support and hemodynamic-guided management versus historical controls; (4) to assess survival to discharge rate in patients receiving intervention from the designated shock team and (5) create a clinical archive of Cardiogenic Shock patient characteristics for future analysis and the support of translational research studies. This is an observational, retrospective, single center study. Retrospective and prospective data will be collected in patients treated at the Inova Heart and Vascular Institute with documented cardiogenic shock as a result of acute decompensated heart failure or acute myocardial infarction. This registry will include data from patients prior to and after the initiation of the multidisciplinary Cardiogenic Shock team on January 1, 2017. Clinical outcomes associated with early multidisciplinary team intervention will be analyzed. In the study group, all patients evaluated for documented cardiogenic shock (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) treated at the Inova Heart and Vascular Institute by the Cardiogenic Shock team will be included. An additional historical Inova Heart and Vascular Institute control group will be analyzed as a comparator. Means with standard deviations will be reported for outcomes. For categorical variables, frequencies and percentages will be presented. For continuous variables, the number of subjects, mean, standard deviation, minimum, 25th percentile, median, 75th percentile and maximum will be reported. Reported differences will include standard errors and 95% CI. Preliminary data analysis for the year 2017 has been completed. Compared to a baseline 2016 survival rate of 47.0%, from 2017 to 2018, CS survival rates were increased to 57.9% (58/110) and 81.3% (81/140), respectively (P=.01 for both). Study data will continue to be collected until December 31, 2018. The preliminary results of this study demonstrate that the INOVA SHOCK team approach to the treatment of Cardiogenic Shock with early team activation, rapid initiation of mechanical circulatory support, hemodynamic-guided management, and strict protocol adherence is associated with superior clinical outcomes: survival to discharge and overall survival when compared to 2015 and 2016 outcomes prior to Shock team initiation. What may limit the generalization of these results of this study to other populations are site specific; expertise of the team, strict algorithm adherence based on the INOVA SHOCK protocol, and staff commitment to timely team activation. Retrospective clinical outcomes (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) demonstrated an increase in current survival rates when compared to pre-Cardiogenic Shock team initiation, rapid team activation and diagnosis and timely utilization of mechanical circulatory support. ClinicalTrials.gov NCT03378739; https://clinicaltrials.gov/ct2/show/NCT03378739 (Archived by WebCite at http://www.webcitation.org/701vstDGd). ©Behnam Tehrani, Alexander Truesdell, Ramesh Singh, Charles Murphy, Patricia Saulino. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.06.2018.

Instrumental variables I: instrumental variables exploit natural variation in nonexperimental data to estimate causal relationships.

PubMed

Rassen, Jeremy A; Brookhart, M Alan; Glynn, Robert J; Mittleman, Murray A; Schneeweiss, Sebastian

2009-12-01

The gold standard of study design for treatment evaluation is widely acknowledged to be the randomized controlled trial (RCT). Trials allow for the estimation of causal effect by randomly assigning participants either to an intervention or comparison group; through the assumption of "exchangeability" between groups, comparing the outcomes will yield an estimate of causal effect. In the many cases where RCTs are impractical or unethical, instrumental variable (IV) analysis offers a nonexperimental alternative based on many of the same principles. IV analysis relies on finding a naturally varying phenomenon, related to treatment but not to outcome except through the effect of treatment itself, and then using this phenomenon as a proxy for the confounded treatment variable. This article demonstrates how IV analysis arises from an analogous but potentially impossible RCT design, and outlines the assumptions necessary for valid estimation. It gives examples of instruments used in clinical epidemiology and concludes with an outline on estimation of effects.

Instrumental variables I: instrumental variables exploit natural variation in nonexperimental data to estimate causal relationships

PubMed Central

Rassen, Jeremy A.; Brookhart, M. Alan; Glynn, Robert J.; Mittleman, Murray A.; Schneeweiss, Sebastian

2010-01-01

The gold standard of study design for treatment evaluation is widely acknowledged to be the randomized controlled trial (RCT). Trials allow for the estimation of causal effect by randomly assigning participants either to an intervention or comparison group; through the assumption of “exchangeability” between groups, comparing the outcomes will yield an estimate of causal effect. In the many cases where RCTs are impractical or unethical, instrumental variable (IV) analysis offers a nonexperimental alternative based on many of the same principles. IV analysis relies on finding a naturally varying phenomenon, related to treatment but not to outcome except through the effect of treatment itself, and then using this phenomenon as a proxy for the confounded treatment variable. This article demonstrates how IV analysis arises from an analogous but potentially impossible RCT design, and outlines the assumptions necessary for valid estimation. It gives examples of instruments used in clinical epidemiology and concludes with an outline on estimation of effects. PMID:19356901

Behavior and Symptom Change Among Women Treated with Placebo for Sexual Dysfunction

PubMed Central

Bradford, Andrea; Meston, Cindy M.

2011-01-01

Introduction In clinical trials of drug treatments for women’s sexual dysfunction, placebo responses have often been substantial. However, little is known about the clinical significance, specificity, predictors, and potential mechanisms of placebo response in sexual dysfunction. Aim We aimed to determine the nature and predictors of sexual function outcomes in women treated with placebo for female sexual arousal disorder (FSAD). Methods We conducted a secondary analysis of data from the placebo arm of a 12-week, multisite, randomized controlled pharmaceutical trial for FSAD (N = 50). We analyzed the magnitude, domain specificity, and clinical significance of sexual function scores at baseline, 4, 8, and 12 weeks (post-treatment). We examined longitudinal change in sexual function outcomes as a function of several baseline variables (e.g., age, symptom-related distress) and in relation to changes in sexual behavior frequency during the trial. Main Outcome Measure Female Sexual Function Index total score. Results The magnitude of change at post-treatment was clinically significant in approximately one-third of placebo recipients. Effect sizes were similar across multiple aspects of sexual function. Symptom improvement was strongly related to the frequency of satisfying sexual encounters during treatment. However, the relationship between sexual encounter frequency and outcome varied significantly between participants. Conclusions A substantial number of women experienced clinically significant improvement in sexual function during treatment with placebo. Changes in sexual behavior during the trial, more so than participant age or symptom severity at baseline, appeared to be an important determinant of outcome. Contextual and procedural aspects of the clinical trial may have influenced outcomes in the absence of an active drug treatment. PMID:20849412

Does duration of symptoms affect clinical outcome after hip arthroscopy for labral tears? Analysis of prospectively collected outcomes with minimum 2-year follow-up

PubMed Central

Ni, Jake; Hohn, Eric A; Domb, Benjamin G

2017-01-01

Abstract Limited research exists on the possible association between duration of symptoms and clinical outcomes following hip arthroscopy for labral tears. The purpose of this study was to evaluate whether duration of symptoms affected clinical and patient-reported outcome (PRO) scores following hip arthroscopy for labral tears. From 2008 to 2011, data were collected prospectively on all patients undergoing primary hip arthroscopy for labral tears. Workers’ compensation cases, dysplasia cases and patients with previous ipsilateral hip surgeries were excluded. A total of 738 patients were identified with a minimum of 2-year follow-up, and clinical and PRO data were available for 680 patients. Uni- and multivariate analyses were performed to determine the relationship between duration of symptoms along with other variables and PROs. Overall, patients experienced significant improvements in all clinical and PRO scores. Results of univariate analysis revealed that all PROs were negatively associated with increasing Log10 months of symptoms as were pain and satisfaction scores. During multivariate analyses, increasing Log10 months of symptoms, age, body mass index and trauma were all negatively associated with PROs (P  < 0.05). Our study demonstrates that clinical and PRO scores were negatively associated with increasing duration of symptoms prior to hip arthroscopy for treatment of labral tears. Although this implies that delay in treatment may adversely affect outcome, conservative treatment remains the gold standard first line of treatment. Surgeons should incorporate this information into their treatment algorithm to maximize patient outcomes following treatment for labral tears. Level of evidence: Level IV, prospective case series. PMID:29250339

Are personal characteristics of massage therapists associated with their clinical, educational, and interpersonal behaviors?

PubMed Central

Boulanger, Karen; Campo, Shelly

2013-01-01

Background Social Cognitive Theory suggests that characteristics of health professionals, such as their beliefs in the effectiveness of their care, influence their behavior. Studying the characteristics of massage therapists may, therefore, provide insight into their clinical, educational and interpersonal behavior, which ultimately affects their client interactions. Purpose To examine the association of three personal factors (outcome expectations, expectancies, and practice experience) of the massage therapist and the practice environment with the frequency of three interventional behaviors (clinical, educational, and interpersonal) using Social Cognitive Theory as a theoretical framework. Methods A random sample of licensed massage therapists in Iowa completed a mailed questionnaire. Questions included training in massage, use of specific massage techniques and practices, 11 outcome expectations, and 17 different behaviors with their respective expectancies for contributing to favorable client outcomes. Factor analyses were conducted on the behavior and expectancy items. Regression analyses were used to examine the relationship of massage therapist characteristics to the different categories of behavior. Results The response rate was 40% (N = 151). The most common techniques employed were Swedish massage, trigger point therapy, and stretching. The most common practices recommended to clients were encouraging water intake, heat application, stretching, stress management, and exercise counseling. Expectancies was the only Social Cognitive Theory variable that significantly predicted the frequency of every category of behavior (clinical, interpersonal, education; all ps < .01). Outcome expectations predicted clinical (p = .03) and educational (p < .01), but not interpersonal behavior. No other associations reached statistical significance. Conclusions Massage therapists’ belief in massage to enact a favorable change in a client is strongly associated with their clinical, educational, and interpersonal behavior. Massage therapists were optimistic regarding the ability of massage to provide a favorable outcome, especially if the desired outcome was supported by research. PMID:24000306

Mental Health of HIV-Seropositive Women During Pregnancy and Postpartum Period: A Comprehensive Literature Review

PubMed Central

Dass-Brailsford, Priscilla; Nora, Diana; Talisman, Nicholas

2014-01-01

With growing numbers of HIV-seropositive (HIV+) women of child-bearing age and increased access to effective clinical protocols for preventing mother-to-child transmission (MTCT) of HIV, mental health-related factors have become increasingly relevant due to their potential to affect the women’s quality of life, obstetric outcomes and risk of MTCT. This review synthesizes evidence from 53 peer-reviewed publications examining mental health-related variables in pregnant and postpartum HIV+ women. The presentation of results is organized by the level of socioeconomic resources in the countries where studies were conducted (i.e., high-, middle-, and low-income countries). It is concluded that psychiatric symptoms, particularly depression, and mental health vulnerabilities (e.g., inadequate coping skills) are widespread among pregnant HIV+ women globally and have a potential to affect psychological well-being, quality of life and salient clinical outcomes. The current body of evidence provides rationale for developing and evaluating clinical and structural interventions aimed at improving mental health outcomes and their clinical correlates in pregnant HIV+ women. PMID:24584458

Significance of Large Vessel Intracranial Occlusion Causing Acute Ischemic Stroke and TIA

PubMed Central

Smith, Wade S.; Lev, Michael H.; English, Joey D.; Camargo, Erica C.; Chou, Maggie; Johnston, S. Claiborne; Gonzalez, Gilberto; Schaefer, Pamela W.; Dillon, William P.; Koroshetz, Walter J.; Furie, Karen L.

2009-01-01

Background: Acute ischemic stroke due to large vessel occlusion (LVO)-vertebral, basilar, carotid terminus, middle and anterior cerebral arteries- likely portends a worse prognosis than stroke unassociated with LVO. Because little prospective angiographic data has been reported on a cohort of unselected stroke and TIA patients, the clinical impact of LVO has been difficult to quantify. Methods: The STOP-Stroke Study is a prospective imaging-based study of stroke outcomes performed at two academic medical centers. Patients with suspected acute stroke who presented within 24 hours of symptom onset and who underwent multi-modality CT/CTA were approached for consent for collection of clinical data and 6 month assessment of outcome. Demographic and clinical variables and 6-month modified Rankin scores (mRS) were collected and combined with blinded interpretation of the CTA data. The odds ratio (OR) of each variable including occlusion of intracranial vascular segment in predicting good outcome and 6-month mortality was calculated using univariate and multivariate logistic regression. Results: Over a 33 month period, 735 patients with suspected stroke were enrolled. Of these, 578 were adjudicated as stroke and 97 as TIA. Among stroke patients, 267 (46%) had LVO accounting for the stroke and 13 (13%) of TIA patients had LVO accounting for TIA symptoms. LVO predicted six-month mortality (OR 4.5; 95% CI 2.7-7.3; p<0.001). Six-month good outcome (mRS≤ 2) was negatively predicted by LVO (0.33; 0.24-0.45; p<0.001). Based on multivariate analysis, the presence of basilar and internal carotid terminus occlusions, in addition to NIHSS and age, independently predicted outcome. Conclusion: Large vessel intracranial occlusion accounted for nearly half of acute ischemic strokes in unselected patients presenting to academic medical centers. In addition to age and baseline stroke severity, occlusion of either the basilar or internal carotid terminus segment is an independent predictor of outcome at 6 months. PMID:19834014

Predictors of treatment outcome among Asian pathological gamblers (PGs): clinical, behavioural, demographic, and treatment process factors.

PubMed

Guo, Song; Manning, Victoria; Thane, Kyaw Kyaw Wai; Ng, Andrew; Abdin, Edimansyah; Wong, Kim Eng

2014-03-01

Research on predictors of treatment outcome among pathological gamblers (PGs) is inconclusive and dominated by studies from Western countries. Using a prospective longitudinal design, the current study examined demographic, clinical, behavioural and treatment programme predictors of gambling frequency at 3, 6 and 12-months, among PGs treated at an addiction clinic in Singapore. Measures included the Hospital anxiety and depression scale, gambling symptom assessment scale (GSAS), personal well-being index (PWI), treatment perception questionnaire and gambling readiness to change scale. Treatment response in relation to changes in symptom severity, personal wellbeing and abstinence were also assessed. Abstinence rates were 38.6, 46.0 and 44.4 % at 3, 6 and 12-months respectively. Significant reductions in gambling frequency, GSAS, and improvement in PWI were reported between baseline and subsequent outcome assessments, with the greatest change occurring in the initial three months. No demographic, clinical, behavioural or treatment programme variable consistently predicted outcome at all three assessments, though treatment satisfaction was the most frequent significant predictor. However, being unemployed, having larger than average debts, poor treatment satisfaction and attending fewer sessions at the later stages of treatment were associated with significantly poorer outcomes, up to 1-year after initiating treatment. These findings show promise for the effectiveness of a CBT-based treatment approach for the treatment of predominantly Chinese PGs. Clinical implications and suggestions for future research are discussed. Taken together, the findings suggest early treatment satisfaction is paramount in improving short-term outcomes, with baseline gambling behaviour and treatment intensity playing a more significant role in the longer term.

Predictors of Full Enteral Feeding Achievement in Very Low Birth Weight Infants

PubMed Central

Corvaglia, Luigi; Fantini, Maria Pia; Aceti, Arianna; Gibertoni, Dino; Rucci, Paola; Baronciani, Dante; Faldella, Giacomo

2014-01-01

Background To elucidate the role of prenatal, neonatal and early postnatal variables in influencing the achievement of full enteral feeding (FEF) in very low birth weight (VLBW) infants and to determine whether neonatal intensive care units (NICUs) differ in this outcome. Methods Population-based retrospective cohort study using data on 1,864 VLBW infants drawn from the “Emilia-Romagna Perinatal Network” Registry from 2004 to 2009. The outcome of interest was time to FEF achievement. Eleven prenatal, neonatal and early postnatal variables and the study NICUs were selected as potential predictors of time to FEF. Parametric survival analysis was used to model time to FEF as a function of the predictors. Marginal effects were used to obtain adjusted estimates of median time to FEF for specific subgroups of infants. Results Lower gestational age, exclusive formula feeding, higher CRIB II score, maternal hypertension, cesarean delivery, SGA and PDA predicted delayed FEF. NICUs proved to be heterogeneous in terms of FEF achievement. Newborns with PDA had a 4.2 days longer predicted median time to FEF compared to those without PDA; newborns exclusively formula-fed had a 1.4 days longer time to FEF compared to those fed human milk. Conclusions The results of our study suggest that time to FEF is influenced by clinical variables and NICU-specific practices. Knowledge of the variables associated with delayed/earlier FEF achievement could help in improving specific aspects of routine clinical management of VLBW infants and to reduce practice variability. PMID:24647523

Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal.

PubMed

Conlon, Anna S C; Taylor, Jeremy M G; Elliott, Michael R

2014-04-01

In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21-29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential surrogate and outcome measures is multivariate normal. From the joint conditional distribution of the potential outcomes of T, given the potential outcomes of S, we propose surrogacy validation measures from this model. As the model is not fully identifiable from the data, we propose some reasonable prior distributions and assumptions that can be placed on weakly identified parameters to aid in estimation. We explore the relationship between our surrogacy measures and the surrogacy measures proposed by Prentice (1989. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8, 431-440). The method is applied to data from a macular degeneration study and an ovarian cancer study.

Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal

PubMed Central

Conlon, Anna S. C.; Taylor, Jeremy M. G.; Elliott, Michael R.

2014-01-01

In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21–29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential surrogate and outcome measures is multivariate normal. From the joint conditional distribution of the potential outcomes of T, given the potential outcomes of S, we propose surrogacy validation measures from this model. As the model is not fully identifiable from the data, we propose some reasonable prior distributions and assumptions that can be placed on weakly identified parameters to aid in estimation. We explore the relationship between our surrogacy measures and the surrogacy measures proposed by Prentice (1989. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8, 431–440). The method is applied to data from a macular degeneration study and an ovarian cancer study. PMID:24285772

International Guillain-Barré Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barré syndrome.

PubMed

Jacobs, Bart C; van den Berg, Bianca; Verboon, Christine; Chavada, Govindsinh; Cornblath, David R; Gorson, Kenneth C; Harbo, Thomas; Hartung, Hans-Peter; Hughes, Richard A C; Kusunoki, Susumu; van Doorn, Pieter A; Willison, Hugh J

2017-06-01

Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy with a highly variable clinical presentation, course, and outcome. The factors that determine the clinical variation of GBS are poorly understood which complicates the care and treatment of individual patients. The protocol of the ongoing International GBS Outcome Study (IGOS), a prospective, observational, multicenter cohort study that aims to identify the clinical and biological determinants and predictors of disease onset, subtype, course and outcome of GBS is presented here. Patients fulfilling the diagnostic criteria for GBS, regardless of age, disease severity, variant forms, or treatment, can participate if included within 2 weeks after onset of weakness. Information about demography, preceding infections, clinical features, diagnostic findings, treatment, course, and outcome is collected. In addition, cerebrospinal fluid and serial blood samples for serum and DNA is collected at standard time points. The original aim was to include at least 1,000 patients with a follow-up of 1-3 years. Data are collected via a web-based data entry system and stored anonymously. IGOS started in May 2012 and by January 2017 included more than 1,400 participants from 143 active centers in 19 countries across 5 continents. The IGOS data/biobank is available for research projects conducted by expertise groups focusing on specific topics including epidemiology, diagnostic criteria, clinimetrics, electrophysiology, antecedent events, antibodies, genetics, prognostic modeling, treatment effects, and long-term outcome of GBS. The IGOS will help to standardize the international collection of data and biosamples for future research of GBS. © 2017 Peripheral Nerve Society.

Effect of intensive oral hygiene regimen during pregnancy on periodontal health, cytokine levels, and pregnancy outcomes: a pilot study.

PubMed

Kaur, Maninder; Geisinger, Maria L; Geurs, Nicolaas C; Griffin, Russell; Vassilopoulos, Philip J; Vermeulen, Lisa; Haigh, Sandra; Reddy, Michael S

2014-12-01

Data are limited on the potential effect of intensive oral hygiene regimens and periodontal therapy during pregnancy on periodontal health, gingival crevicular fluid (GCF) and serum cytokines, and pregnancy outcomes. A clinical trial was conducted on 120 community-dwelling, 16- to 35-year-old pregnant women at 16 to 24 weeks of gestation. Each participant presented with clinical evidence of generalized, moderate-to-severe gingivitis. Oral hygiene products were provided, together with instructions for an intensive daily regimen of hygiene practices. Non-surgical therapy was provided at baseline. Oral examinations were completed at baseline and again at 4 and 8 weeks. In addition, samples of blood and GCF were collected at baseline and week 8. Mean changes in clinical variables and GCF and serum cytokine levels (interleukin [IL]-1β, IL-6, tumor necrosis factor [TNF]-α) between baseline and week 8 were calculated using paired t test. Pregnancy outcomes were recorded at parturition. RESULTS indicated a statistically significant reduction in all clinical variables (P <0.0001) and decreased levels of TNF-α (P = 0.0076) and IL-1β (P = 0.0098) in GCF during the study period. The rate of preterm births (<37 weeks of gestation) was 6.7% (P = 0.113) and low birth weight (<2,500 g) was 10.2% (P = 1.00). Among the population studied, intensive instructions and non-surgical periodontal therapy provided during 8 weeks at early pregnancy resulted in decreased gingival inflammation and a generalized improvement in periodontal health. Large-scale, randomized, controlled studies are needed to substantiate these findings.

On heterogeneity of treatment effects and clinical freedom.

PubMed

Sacristán, J A; Avendaño-Solá, C

2015-01-01

Three decades ago, John R Hampton announced the death of clinical freedom. Since then, evidence-based medicine has been the predominant paradigm in clinical research. By applying a population-based approach, the randomised controlled trial has become the cornerstone for demonstrating the overall effect of a treatment and for developing guidelines. The new patient-centred medicine movement is rediscovering the important implications of heterogeneity of treatment effects for clinical practice and that a better understanding of such variability can contribute to improve health outcomes for individual patients through practicing a science-based clinical freedom. © 2015 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Variability in Effective Radiating Area and Output Power of New Ultrasound Transducers at 3 MHz

PubMed Central

Johns, Lennart D; Straub, Stephen J; Howard, Samuel M

2007-01-01

Context: Spatial average intensity (SAI) is often used by clinicians to gauge therapeutic ultrasound dosage, yet SAI measures are not directly regulated by US Food and Drug Administration (FDA) standards. Current FDA guidelines permit a possible 50% to 150% minimum to maximum range of SAI values, potentially contributing to variability in clinical outcomes. Objective: To measure clinical values that describe ultrasound transducers and to determine the degree of intramanufacturer and intermanufacturer variability in effective radiating area, power, and SAI when the transducer is functioning at 3 MHz. Design: A descriptive and interferential approach was taken to this quasi-experimental design. Setting: Measurement laboratory. Patients or Other Participants: Sixty-six 5-cm2 ultrasound transducers were purchased from 6 different manufacturers. Intervention(s): All transducers were calibrated and then assessed using standardized measurement techniques; SAI was normalized to account for variability in effective radiating area, resulting in an nSAI. Main Outcome Measure(s): Effective radiating area, power, and nSAI. Results: All manufacturers with the exception of Omnisound (P = .534) showed a difference between the reported and measured effective radiating area values (P < .001). All transducers were within FDA guidelines for power (±20%). Chattanooga (0.85 ± 0.05 W/cm2) had a lower nSAI (P < .05) than all other manufacturers functioning at 3 MHz. Intramanufacturer variability in SAI ranged from 16% to 35%, and intermanufacturer variability ranged from 22% to 61%. Conclusions: Clinicians should consider treatment values of each individual transducer, regardless of the manufacturer. In addition, clinicians should scrutinize the power calibration and recalibration record of the transducer and adjust clinical settings as needed for the desired level of heating. Our data may aid in explaining the reported heating differences among transducers from different manufacturers. Stricter FDA standards regarding effective radiating area and total power are needed, and standards regulating SAI should be established. PMID:17597939

Duration of untreated illness in panic disorder: a poor outcome risk factor?

PubMed

Altamura, A Carlo; Santini, Annalisa; Salvadori, Daniele; Mundo, Emanuela

2005-12-01

The aim of this naturalistic study was to evaluate the impact of the duration of untreated illness (DUI) on the outcome and treatment response of panic disorder (PD). Ninety-six outpatients with PD who underwent an 8-week open-label treatment with serotonergic antidepressants were subdivided into two subgroups: those with DUI 1 year. The main baseline demographic and clinical variables were calculated and compared between the two subgroups of patients (chi-square test or t-test for independent samples). The effect of the antipanic medication was evaluated by analysis of variance with repeated measures considering Hamilton Rating Scale for Anxiety, Clinical Global Impression rating scores, and the number of panic attacks/week as the dependent variables (outcome measures), while the subgroups were the independent ones. Comorbidity with onset later than PD was also considered. There were no differences between patients with DUI 1 year with respect to the outcome measures considered. However, patients with DUI > 1 year (N = 64) had a higher frequency of comorbid major depressive disorder (MDD) with onset later than PD (p = 0.006). Results from this study suggest that the DUI may be a predictor of the development of comorbid MDD in PD. Further investigations on larger samples and with longer follow-up are warranted.

Duration of untreated illness in panic disorder: a poor outcome risk factor?

PubMed Central

Altamura, A Carlo; Santini, Annalisa; Salvadori, Daniele; Mundo, Emanuela

2005-01-01

Objective The aim of this naturalistic study was to evaluate the impact of the duration of untreated illness (DUI) on the outcome and treatment response of panic disorder (PD). Methods Ninety-six outpatients with PD who underwent an 8-week open-label treatment with serotonergic antidepressants were subdivided into two subgroups: those with DUI ≤ 1 year and those with DUI > 1 year. The main baseline demographic and clinical variables were calculated and compared between the two subgroups of patients (chi-square test or t-test for independent samples). The effect of the antipanic medication was evaluated by analysis of variance with repeated measures considering Hamilton Rating Scale for Anxiety, Clinical Global Impression rating scores, and the number of panic attacks/week as the dependent variables (outcome measures), while the subgroups were the independent ones. Comorbidity with onset later than PD was also considered. Results There were no differences between patients with DUI ≤ 1 year and patients with DUI > 1 year with respect to the outcome measures considered. However, patients with DUI > 1 year (N = 64) had a higher frequency of comorbid major depressive disorder (MDD) with onset later than PD (p = 0.006). Conclusions Results from this study suggest that the DUI may be a predictor of the development of comorbid MDD in PD. Further investigations on larger samples and with longer follow-up are warranted. PMID:18568114

Dysthymic Disorder and Double Depression: Prediction of 10-Year Course Trajectories and Outcomes

PubMed Central

Klein, Daniel N.; Shankman, Stewart A.; Rose, Suzanne

2008-01-01

We sought to identify baseline predictors of 10-year course trajectories and outcomes in patients with dysthymic disorder and double depression. Eighty-seven outpatients with early-onset (< 21 years) dysthymic disorder, with or without superimposed major depression, were assessed five times at 30-month intervals for 10 years. Baseline evaluations included semi-structured diagnostic interviews for Axis I and II psychopathology and childhood adversity. Direct interview and family history data were collected on first-degree relatives. Follow-up assessments included the Longitudinal Follow-up Evaluation and Hamilton Depression Rating Scale. Using mixed effects growth curve models, univariate predictors of depression severity and functional impairment at 10-year outcome included older age, less education, concurrent anxiety disorder, greater familial loading for chronic depression, a history of a poorer maternal relationship in childhood, and a history of childhood sexual abuse. In addition, longer duration of dysthymic disorder also predicted greater impairment 10 years later. Predictors of a poorer trajectory of depressive symptoms over time included ethnicity and personality disorders; predictors of a poorer trajectory of social functioning included familial loading of chronic depression and quality of the childhood maternal relationship. Thus, demographic, clinical, family history, and early adversity variables all contribute to predicting the long term trajectory and outcome of DD. These variables should be routinely assessed in clinical evaluations and can provide clinicians with valuable prognostic information. PMID:17466334

Dysthymic disorder and double depression: prediction of 10-year course trajectories and outcomes.

PubMed

Klein, Daniel N; Shankman, Stewart A; Rose, Suzanne

2008-04-01

We sought to identify baseline predictors of 10-year course trajectories and outcomes in patients with dysthymic disorder and double depression. Eighty-seven outpatients with early-onset (<21 years) dysthymic disorder, with or without superimposed major depression, were assessed five times at 30-month intervals for 10 years. Baseline evaluations included semi-structured diagnostic interviews for Axis I and II psychopathology and childhood adversity. Direct interview and family history data were collected on first-degree relatives. Follow-up assessments included the Longitudinal Follow-up Evaluation and Hamilton Depression Rating Scale. Using mixed effects growth curve models, univariate predictors of depression severity and functional impairment at 10-year outcome included older age, less education, concurrent anxiety disorder, greater familial loading for chronic depression, a history of a poorer maternal relationship in childhood, and a history of childhood sexual abuse. In addition, longer duration of dysthymic disorder also predicted greater impairment 10 years later. Predictors of a poorer trajectory of depressive symptoms over time included ethnicity and personality disorders; predictors of a poorer trajectory of social functioning included familial loading of chronic depression and quality of the childhood maternal relationship. Thus, demographic, clinical, family history, and early adversity variables all contribute to predicting the long-term trajectory and outcome of DD. These variables should be routinely assessed in clinical evaluations and can provide clinicians with valuable prognostic information.

Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation.

PubMed

McMillan, Matthew T; Soi, Sameer; Asbun, Horacio J; Ball, Chad G; Bassi, Claudio; Beane, Joal D; Behrman, Stephen W; Berger, Adam C; Bloomston, Mark; Callery, Mark P; Christein, John D; Dixon, Elijah; Drebin, Jeffrey A; Castillo, Carlos Fernandez-Del; Fisher, William E; Fong, Zhi Ven; House, Michael G; Hughes, Steven J; Kent, Tara S; Kunstman, John W; Malleo, Giuseppe; Miller, Benjamin C; Salem, Ronald R; Soares, Kevin; Valero, Vicente; Wolfgang, Christopher L; Vollmer, Charles M

2016-08-01

To evaluate surgical performance in pancreatoduodenectomy using clinically relevant postoperative pancreatic fistula (CR-POPF) occurrence as a quality indicator. Accurate assessment of surgeon and institutional performance requires (1) standardized definitions for the outcome of interest and (2) a comprehensive risk-adjustment process to control for differences in patient risk. This multinational, retrospective study of 4301 pancreatoduodenectomies involved 55 surgeons at 15 institutions. Risk for CR-POPF was assessed using the previously validated Fistula Risk Score, and pancreatic fistulas were stratified by International Study Group criteria. CR-POPF variability was evaluated and hierarchical regression analysis assessed individual surgeon and institutional performance. There was considerable variability in both CR-POPF risk and occurrence. Factors increasing the risk for CR-POPF development included increasing Fistula Risk Score (odds ratio 1.49 per point, P < 0.00001) and octreotide (odds ratio 3.30, P < 0.00001). When adjusting for risk, performance outliers were identified at the surgeon and institutional levels. Of the top 10 surgeons (≥15 cases) for nonrisk-adjusted performance, only 6 remained in this high-performing category following risk adjustment. This analysis of pancreatic fistulas following pancreatoduodenectomy demonstrates considerable variability in both the risk and occurrence of CR-POPF among surgeons and institutions. Disparities in patient risk between providers reinforce the need for comprehensive, risk-adjusted modeling when assessing performance based on procedure-specific complications. Furthermore, beyond inherent patient risk factors, surgical decision-making influences fistula outcomes.

An assessment of lifestyle modification versus medical treatment with clomiphene citrate, metformin, and clomiphene citrate-metformin in patients with polycystic ovary syndrome.

PubMed

Karimzadeh, Mohammad Ali; Javedani, Mojgan

2010-06-01

To compare the effect of clomiphene citrate, metformin, and lifestyle modification on treatment of patients with polycystic ovary syndrome (PCOS). Prospective randomized double-blind study. University-based infertility clinic and research center. Three hundred forty-three overweight infertile women with PCOS. The participating women were assigned to four groups: clomiphene (n = 90), metformin (n = 90), clomiphene + metformin (n = 88), and lifestyle modification (n = 75). The patients in each group received standardized dietary and exercise advice from a dietitian. The primary outcome variables were change in menstrual cycle, waist circumference measurements, endocrine parameters, and lipid profile. The main secondary outcome variable was clinical pregnancy rate. The clinical pregnancy rate was 12.2% in clomiphene group, 14.4% in metformin group, 14.8% in clomiphene + metformin group, and 20% in lifestyle modification group. Lifestyle modification group achieved a significant reduction in waist circumference, total androgen, and lipid profile. Lifestyle modification improves the lipid profile in PCOS patients. Therefore, lifestyle modification may be used as the first line of ovulation induction in PCOS patients. Copyright (c) 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Dietary interventions in overweight and obese pregnant women: a systematic review of the content, delivery, and outcomes of randomized controlled trials.

PubMed

Flynn, Angela C; Dalrymple, Kathryn; Barr, Suzanne; Poston, Lucilla; Goff, Louise M; Rogozińska, Ewelina; van Poppel, Mireille N M; Rayanagoudar, Girish; Yeo, SeonAe; Barakat Carballo, Ruben; Perales, Maria; Bogaerts, Annick; Cecatti, Jose G; Dodd, Jodie; Owens, Julie; Devlieger, Roland; Teede, Helena; Haakstad, Lene; Motahari-Tabari, Narges; Tonstad, Serena; Luoto, Riitta; Guelfi, Kym; Petrella, Elisabetta; Phelan, Suzanne; Scudeller, Tânia T; Hauner, Hans; Renault, Kristina; Sagedal, Linda Reme; Stafne, Signe N; Vinter, Christina; Astrup, Arne; Geiker, Nina R W; McAuliffe, Fionnuala M; Mol, Ben W; Thangaratinam, Shakila

2016-05-01

Interventions targeting maternal obesity are a healthcare and public health priority. The objective of this review was to evaluate the adequacy and effectiveness of the methodological designs implemented in dietary intervention trials for obesity in pregnancy. A systematic review of the literature, consistent with PRISMA guidelines, was performed as part of the International Weight Management in Pregnancy collaboration. Thirteen randomized controlled trials, which aimed to modify diet and physical activity in overweight and obese pregnant women, were identified. There was significant variability in the content, delivery, and dietary assessment methods of the dietary interventions examined. A number of studies demonstrated improved dietary behavior in response to diet and/or lifestyle interventions. Nine studies reduced gestational weight gain. This review reveals large methodological variability in dietary interventions to control gestational weight gain and improve clinical outcomes in overweight and obese pregnant women. This lack of consensus limits the ability to develop clinical guidelines and apply the evidence in clinical practice. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Uncemented total hip arthroplasty in octogenarian and nonagenarian patients.

PubMed

Toro, Giuseppe; Bothorel, Hugo; Saffarini, Mo; Jacquot, Laurent; Chouteau, Julien; Rollier, Jean-Charles

2018-06-02

While uncemented THA has proven benefits over cemented THA, the use of uncemented components in the elderly remains controversial. The purpose of this study was to compare functional outcomes and complication rates of uncemented THA in patients aged > 80 to patients aged < 80, and determine factors that independently influence functional outcomes. The authors evaluated 411 consecutive uncemented THAs at a follow-up of 3.1 ± 0.9 years (range 1.8-5.2), using the Oxford hip score (OHS), EuroQol 5 Dimensions (EQ-5D) score, and noting any complications. The series was divided into two age groups: elderly group (> 80, n = 142) and control group (< 80, n = 269). Uni- and multi-variable regressions were performed to test associations between outcomes and patient age, BMI, American Society of Anaesthesiologists (ASA) score, canal bone ratio (CBR) and canal flare index (CFI). The elderly group had femora with higher CBR (p < 0.001) and lower CFI (p = 0.002). The clinical scores were significantly worse for the elderly group, with a higher OHS (p = 0.039) and a lower EQ-5D score (p = 0.009), but there were no significant differences in overall complications rates (p = 0.500). Periprosthetic fractures were observed in three elderly patients (2.1%), compared to none of the younger patients (p = 0.041). Multi-variable regressions revealed that OHS was not correlated with any of the variables, while EQ-5D score was significantly associated with BMI (p = 0.015), ASA score (p = 0.024) and CBR (p = 0.019). Clinical outcomes of uncemented THA do not depend on patient age per se, but on more specific preoperative characteristics such as ASA score, BMI and bone quality/morphology.

Incidence and Clinical Outcome of Hypophosphatemia in Pediatric Burn Patients.

PubMed

Leite, Heitor Pons; Pinheiro Nogueira, Larissa Araújo; Teodosio, Ariane Helena Calassa

The objective of this study is to investigate the factors associated with serum phosphate concentrations in severely burned children and whether hypophosphatemia is associated with outcome. Seventy-eight children with a total body surface area of 24% (6.0-68.5) were retrospectively analyzed for serum phosphate concentrations during the first 10 days of stay in the intensive care unit (ICU). The method of generalized estimating equations was used to evaluate the effect of the exposure variables for serum phosphate concentrations during the study period. Outcome variables were the probability of ICU discharge at 30 days and time on mechanical ventilation. Potential explanatory variables for clinical outcome were hypophosphatemia (serum phosphate <3.8 mg/dL for children <2 years and <3.5 mg/dL for older children), age, sex, percent total body surface area burn, inhalation injury, and severe sepsis and/or septic shock. Competing-risk analysis was applied to calculate the probability of ICU discharge at 30 days, and death was assumed as the competing event. The rate of hypophosphatemia was 79.5%. Serum phosphate concentrations were associated with C-reactive protein (coefficient: -0.63; 95% confidence interval [CI]: -0.96 to -0.30; P = .001). Hypophosphatemia was independently associated with a 68% decrease in the probability of ICU discharge at 30 days (subhazard ratio: -0.32; 95% CI: 0.20, 0.53; P = .001) and an increase of 2.9 days in mechanical ventilation (coefficient: 2.91; 95% CI: 1.16, 4.66; P = .001). Serum phosphate concentrations in pediatric burn patients are associated with the magnitude of inflammatory response. Hypophosphatemia is associated with decreased probability of ICU discharge and increased time on mechanical ventilation.

Cytokines Synergize to Combat Metastatic Neuroblastoma | Center for Cancer Research

Cancer.gov

Neuroblastoma is the most common extracranial solid tumor in children, and clinical outcomes of patients with this disease are quite variable. Prognosis is particularly poor for patients with high-risk tumors (classification based on patients’ age, extent of disease spread, and other biological features).

Acute Kidney Injury in Critically Ill Patients with Sepsis: Clinical Characteristics and Outcomes.

PubMed

Zhi, De-Yuan; Lin, Jin; Zhuang, Hai-Zhou; Dong, Lei; Ji, Xiao-Jun; Guo, Dong-Cheng; Yang, Xiao-Wei; Liu, Shuai; Yue, Zu; Yu, Shu-Jing; Duan, Mei-Li

2018-04-25

The objectives of this study were to examine the clinical profile of critically ill patients with septic acute kidney injury (AKI) and to investigate clinical characteristics associated with the outcome of patients. Data from 582 critically ill patients were collected and retrospectively reviewed. Patients were divided into two groups: without AKI development and with AKI development. Baseline characteristics, laboratory, and other clinical data were compared between these two groups, and correlations between the characteristics and AKI development were examined. Patients with AKI development were further divided into two groups according to the survival outcome, and variables associated with the outcome were determined. AKI was developed in 54.12% (n = 315) of patients, and these patients had blood pressure, SOFA score, APACHE II score, GCS, and various blood chemistry and hematology characteristics significantly different from the patients without AKI. Demographic characteristics (e.g. age and weight) were comparable between the two groups of patients. Among the 315 patients with AKI, 136 of them died during the study period. Multivariate logistic regression analysis revealed that the outcome of patients was associated with lung infection, coagulation system dysfunction, staphylococcus aureus infection, and use of various treatments (epinephrine, norepinephrine, and the use of mechanical ventilation) after AKI development. AKI occurred in approximately half of the critically ill patients admitted to ICU. The site and type of infections, as well as the use of vasopressor agents, were associated with the outcome.

Presence of Genes Encoding Panton-Valentine Leukocidin Is Not the Primary Determinant of Outcome in Patients with Hospital-Acquired Pneumonia Due to Staphylococcus aureus

PubMed Central

Sharma-Kuinkel, Batu K.; Ahn, Sun H.; Rude, Thomas H.; Zhang, Yurong; Tong, Steven Y. C.; Ruffin, Felicia; Genter, Fredric C.; Braughton, Kevin R.; DeLeo, Frank R.; Barriere, Steven L.

2012-01-01

The impact of Panton-Valentine leukocidin (PVL) on the outcome in Staphylococcus aureus pneumonia is controversial. We genotyped S. aureus isolates from patients with hospital-acquired pneumonia (HAP) enrolled in two registrational multinational clinical trials for the genetic elements carrying pvl and 30 other virulence genes. A total of 287 isolates (173 methicillin-resistant S. aureus [MRSA] and 114 methicillin-susceptible S. aureus [MSSA] isolates) from patients from 127 centers in 34 countries for whom clinical outcomes of cure or failure were available underwent genotyping. Of these, pvl was detected by PCR and its product confirmed in 23 isolates (8.0%) (MRSA, 18/173 isolates [10.4%]; MSSA, 5/114 isolates [4.4%]). The presence of pvl was not associated with a higher risk for clinical failure (4/23 [17.4%] versus 48/264 [18.2%]; P = 1.00) or mortality. These findings persisted after adjustment for multiple potential confounding variables. No significant associations between clinical outcome and (i) presence of any of the 30 other virulence genes tested, (ii) presence of specific bacterial clone, (iii) levels of alpha-hemolysin, or (iv) delta-hemolysin production were identified. This study suggests that neither pvl presence nor in vitro level of alpha-hemolysin production is the primary determinant of outcome among patients with HAP caused by S. aureus. PMID:22205797

Predicting outcome of Internet-based treatment for depressive symptoms.

PubMed

Warmerdam, Lisanne; Van Straten, Annemieke; Twisk, Jos; Cuijpers, Pim

2013-01-01

In this study we explored predictors and moderators of response to Internet-based cognitive behavioral therapy (CBT) and Internet-based problem-solving therapy (PST) for depressive symptoms. The sample consisted of 263 participants with moderate to severe depressive symptoms. Of those, 88 were randomized to CBT, 88 to PST and 87 to a waiting list control condition. Outcomes were improvement and clinically significant change in depressive symptoms after 8 weeks. Higher baseline depression and higher education predicted improvement, while higher education, less avoidance behavior and decreased rational problem-solving skills predicted clinically significant change across all groups. No variables were found that differentially predicted outcome between Internet-based CBT and Internet-based PST. More research is needed with sufficient power to investigate predictors and moderators of response to reveal for whom Internet-based therapy is best suited.

Health literacy and patient outcomes in chronic kidney disease: a systematic review.

PubMed

Taylor, Dominic M; Fraser, Simon; Dudley, Chris; Oniscu, Gabriel C; Tomson, Charles; Ravanan, Rommel; Roderick, Paul

2017-11-20

Limited health literacy affects 25% of people with chronic kidney disease (CKD), and may reduce self-management skills resulting in poorer clinical outcomes. By disproportionately affecting people with low socio-economic status and non-white ethnicity, limited health literacy may promote health inequity. We performed a systematic review of quantitative studies of health literacy and clinical outcomes among adults with CKD. A total of 29 studies (13 articles; 16 conference abstracts) were included. One included non-USA patients. Of the 29 studies, 5 were cohort studies and 24 were cross-sectional. In all, 18 300 patients were studied: 4367 non-dialysis CKD; 13 202 dialysis; 390 transplant; 341 unspecified. Median study size was 127 [interquartile range (IQR) 92-238)], but 480 (IQR 260-2392) for cohort studies. Median proportion of non-white participants was 48% (IQR 17-70%). Six health literacy measures were used. Outcomes included patient attributes, care processes, clinical/laboratory parameters and 'hard' clinical outcomes. Limited health literacy was significantly, independently associated with hospitalizations, emergency department use, missed dialysis sessions, cardiovascular events and mortality (in cohort studies). Study quality was high (1 study), moderate (3 studies) and poor (25 studies), limited by sampling methods, variable adjustment for confounders and reduced methodological detail given in conference abstracts. There is limited robust evidence of the causal effects of health literacy on patient outcomes in CKD. Available evidence suggests associations with adverse clinical events, increased healthcare use and mortality. Prospective studies are required to determine the causal effects of health literacy on outcomes in CKD patients, and examine the relationships between socio-economic status, comorbidity, health literacy and CKD outcomes. Intervention development and evaluation will determine whether health literacy is a modifiable determinant of poor outcomes in CKD. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

What Variables are Associated with Successful Weight Loss Outcomes for Bariatric Surgery After One Year?

PubMed Central

Robinson, Athena H.; Adler, Sarah; Stevens, Helen B.; Darcy, Alison M.; Morton, John M.; Safer, Debra L.

2014-01-01

Background Prior evidence indicates that predictors of weight loss outcomes after gastric bypass surgery fall within 5 domains: 1) presurgical factors; 2) postsurgical psychosocial variables (e.g., support group attendance); 3) postsurgical eating patterns; 4) postsurgical physical activity; and 5) follow-up at postsurgical clinic. However, little data exist on which specific behavioral predictors are most associated with successful outcomes (e.g., ≥50% excess weight loss) when considering the 5 domains simultaneously. Objectives Specify the behavioral variables, and their respective cutoff points, most associated with successful weight loss outcomes. Setting On-line survey. Methods Signal Detection Analysis evaluated associations between 84 pre-and postsurgical behavioral variables (within the 5 domains) and successful weight loss at ≥1 year in 274 post-gastric bypass surgery patients. Results Successful weight loss was highest (92.6%) among those reporting dietary adherence of >3 on a 9 point scale (median=5) who grazed no more than once-per-day. Among participants reporting dietary adherence <3 and grazing daily or less, success rates more than doubled when highest lifetime Body Mass Index was <53.7 kg/m2. Success rates also doubled for participants with dietary adherence =3 if attending support groups. No variables from the physical activity or postsurgical follow-up domains were significant, nor were years since surgery. The overall model’s sensitivity =.62, specificity =.92. Conclusions To our knowledge, this is the first study to simultaneously consider the relative contribution of behavioral variables within 5 domains and offer clinicians an assessment algorithm identifying cut-off points for behaviors most associated with successful postsurgical weight loss. Such data may inform prospective study designs and postsurgical interventions. PMID:24913590

Split-mouth comparison of physics forceps and extraction forceps in orthodontic extraction of upper premolars.

PubMed

Hariharan, Samyuktha; Narayanan, Vinod; Soh, Chen Loong

2014-12-01

We compared outcome variables (operative complications, inflammatory complications, and operating time) in patients being treated by orthodontic extraction of upper premolars with the Physics forceps or the universal extraction forceps. We organised a single blind, split-mouth clinical trial to compare the outcomes of the 2 groups (n=54 premolars). The Physics forceps group had lower mean (SD) visual analogue scores (VAS) for pain (0.59 (0.57)) on the first postoperative day than the other group (1.04 (0.85)) (p=0.03). There were no other significant differences between the 2 groups in any other variable studied. Copyright © 2014 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Psychobiologic correlates of treatment response in schizophrenia.

PubMed

Lieberman, J A; Alvir, J M; Koreen, A; Geisler, S; Chakos, M; Sheitman, B; Woerner, M

1996-03-01

In studies conducted on largely treatment naive patients in their first episode of psychosis, we have found that treatment outcome is quite good and that most patients recover or at least achieve a substantial degree of symptom remission. However, over the course of their illness and in the context of subsequent psychotic episodes, they may experience some decrease in their treatment response from illness progression. In addition, the heterogeneity of treatment outcome is associated with specific clinical (gender, primary negative symptoms of the deficit state, duration of psychosis) and biological variables (pHVA, ventricular volume). It is unclear whether these variables represent aspects of discrete subtypes of schizophrenia or dimensional measures of pathology within the broad context of a unitary disease entity.

Analysis of long-term (median 10.5 years) outcomes in children presenting with traumatic brain injury and an initial Glasgow Coma Scale score of 3 or 4.

PubMed

Fulkerson, Daniel H; White, Ian K; Rees, Jacqueline M; Baumanis, Maraya M; Smith, Jodi L; Ackerman, Laurie L; Boaz, Joel C; Luerssen, Thomas G

2015-10-01

Patients with traumatic brain injury (TBI) with low presenting Glasgow Coma Scale (GCS) scores have very high morbidity and mortality rates. Neurosurgeons may be faced with difficult decisions in managing the most severely injured (GCS scores of 3 or 4) patients. The situation may be considered hopeless, with little chance of a functional recovery. Long-term data are limited regarding the clinical outcome of children with severe head injury. The authors evaluate predictor variables and the clinical outcomes at discharge, 1 year, and long term (median 10.5 years) in a cohort of children with TBI presenting with postresuscitation GCS scores of 3 and 4. A review of a prospectively collected trauma database was performed. Patients treated at Riley Hospital for Children (Indianapolis, Indiana) from 1988 to 2004 were reviewed. All children with initial GCS (modified for pediatric patients) scores of 3 or 4 were identified. Patients with a GCS score of 3 were compared with those with a GCS score of 4. The outcomes of all patients at the time of death or discharge and at 1-year and long-term follow-up were measured with a modified Glasgow Outcome Scale (GOS) that included a "normal" outcome. Long-term outcomes were evaluated by contacting surviving patients. Statistical "classification trees" were formed for survival and outcome, based on predictor variables. Sixty-seven patients with a GCS score of 3 or 4 were identified in a database of 1636 patients (4.1%). Three of the presenting factors differed between the GCS 3 patients (n = 44) and the GCS 4 patients (n = 23): presence of hypoxia, single seizure, and open basilar cisterns on CT scan. The clinical outcomes were statistically similar between the 2 groups. In total, 48 (71.6%) of 67 patients died, remained vegetative, or were severely disabled by 1 year. Eight patients (11.9%) were normal at 1 year. Ten of the 22 patients with long-term follow-up were either normal or had a GOS score of 5. Multiple clinical, historical, and radiological factors were analyzed for correlation with survival and clinical outcome. Classification trees were formed to stratify predictive factors. The pupillary response was the factor most predictive of both survival and outcome. Other factors that either positively or negatively correlated with survival included hypothermia, mechanism of injury (abuse), hypotension, major concurrent symptoms, and midline shift on CT scan. Other factors that either positively or negatively predicted long-term outcome included hypothermia, mechanism of injury, and the assessment of the fontanelle. In this cohort of 67 TBI patients with a presenting GCS score of 3 or 4, 56.6% died within 1 year. However, approximately 15% of patients had a good outcome at 10 or more years. Factors that correlated with survival and outcome included the pupillary response, hypothermia, and mechanism. The authors discuss factors that may help surgeons make critical decisions regarding their most serious pediatric trauma patients.

Tumor-infiltrating T lymphocytes improve clinical outcome of therapy-resistant neuroblastoma.

PubMed

Mina, Marco; Boldrini, Renata; Citti, Arianna; Romania, Paolo; D'Alicandro, Valerio; De Ioris, Maretta; Castellano, Aurora; Furlanello, Cesare; Locatelli, Franco; Fruci, Doriana

2015-09-01

Neuroblastoma grows within an intricate network of different cell types including epithelial, stromal and immune cells. The presence of tumor-infiltrating T cells is considered an important prognostic indicator in many cancers, but the role of these cells in neuroblastoma remains to be elucidated. Herein, we examined the relationship between the type, density and organization of infiltrating T cells and clinical outcome within a large collection of neuroblastoma samples by quantitative analysis of immunohistochemical staining. We found that infiltrating T cells have a prognostic value greater than, and independent of, the criteria currently used to stage neuroblastoma. A variable in situ structural organization and different concurrent infiltration of T-cell subsets were detected in tumors with various outcomes. Low-risk neuroblastomas were characterized by a higher number of proliferating T cells and a more structured T-cell organization, which was gradually lost in tumors with poor prognosis. We defined an immunoscore based on the presence of CD3 + , CD4 + and CD8 + infiltrating T cells that associates with favorable clinical outcome in MYCN-amplified tumors, improving patient survival when combined with the v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status. These findings support the hypothesis that infiltrating T cells influence the behavior of neuroblastoma and might be of clinical importance for the treatment of patients.

Impact of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) on cancer treatment outcomes: An overview about well-established and recently emerging clinical data.

PubMed

Lalami, Yassine; Klastersky, Jean

2017-12-01

Despite the overwhelming evidence for the role of granulocyte colony stimulating factors (G-CSF) in managing febrile neutropenia (FN) risk, chemotherapy-induced neutropenia (CIN) and/or FN still remain the most common reasons for reducing relative dose intensity (RDI) and/or delaying chemotherapy schedule. The need to maintain RDI to ensure optimal clinical outcomes is one of the key rationales for utilizing G-CSF. There is a high incidence of reduced RDI in both curative and palliative settings, and this observation is especially evidenced in retrospective analyses. Reduced RDI leads to significantly decreased survival outcomes and quality of life in various malignancies at various clinical settings and stages. Beyond its role as a surrogate prognostic marker, high-grade CIN may have an unexpected predictive role in clinical practice, as illustrated by several data relating CIN occurrence with favorable survival outcomes; this may be due to the fact that body surface area (BSA) - based calculation of dose may not fully account for the pharmacokinetics (PK) of cytotoxic drugs and the fact that there may be variability in drug metabolism between patients treated with same chemotherapy regimens. Copyright © 2017 Elsevier B.V. All rights reserved.

A Systematic Review on the Designs of Clinical Technology: Findings and Recommendations for Future Research

PubMed Central

PhD, Greg Alexander; Staggers, Nancy

2010-01-01

Human factors (HF) studies are increasingly important as technology infuses into clinical settings. No nursing research reviews exist in this area. The authors conducted a systematic review on designs of clinical technology, 34 articles with 50 studies met inclusion criteria. Findings were classified into three categories based on HF research goals. The majority of studies evaluated effectiveness of clinical design; efficiency was fewest. Current research ranges across many interface types examined with no apparent pattern or obvious rationale. Future research should expand types, settings, participants; integrate displays; and expand outcome variables. PMID:19707093

Determination of patellofemoral pain sub-groups and development of a method for predicting treatment outcome using running gait kinematics.

PubMed

Watari, Ricky; Kobsar, Dylan; Phinyomark, Angkoon; Osis, Sean; Ferber, Reed

2016-10-01

Not all patients with patellofemoral pain exhibit successful outcomes following exercise therapy. Thus, the ability to identify patellofemoral pain subgroups related to treatment response is important for the development of optimal therapeutic strategies to improve rehabilitation outcomes. The purpose of this study was to use baseline running gait kinematic and clinical outcome variables to classify patellofemoral pain patients on treatment response retrospectively. Forty-one individuals with patellofemoral pain that underwent a 6-week exercise intervention program were sub-grouped as treatment Responders (n=28) and Non-responders (n=13) based on self-reported measures of pain and function. Baseline three-dimensional running kinematics, and self-reported measures underwent a linear discriminant analysis of the principal components of the variables to retrospectively classify participants based on treatment response. The significance of the discriminant function was verified with a Wilk's lambda test (α=0.05). The model selected 2 gait principal components and had a 78.1% classification accuracy. Overall, Non-responders exhibited greater ankle dorsiflexion, knee abduction and hip flexion during the swing phase and greater ankle inversion during the stance phase, compared to Responders. This is the first study to investigate an objective method to use baseline kinematic and self-report outcome variables to classify on patellofemoral pain treatment outcome. This study represents a significant first step towards a method to help clinicians make evidence-informed decisions regarding optimal treatment strategies for patients with patellofemoral pain. Copyright © 2016 Elsevier Ltd. All rights reserved.

Identifying novel phenotypes of acute heart failure using cluster analysis of clinical variables.

PubMed

Horiuchi, Yu; Tanimoto, Shuzou; Latif, A H M Mahbub; Urayama, Kevin Y; Aoki, Jiro; Yahagi, Kazuyuki; Okuno, Taishi; Sato, Yu; Tanaka, Tetsu; Koseki, Keita; Komiyama, Kota; Nakajima, Hiroyoshi; Hara, Kazuhiro; Tanabe, Kengo

2018-07-01

Acute heart failure (AHF) is a heterogeneous disease caused by various cardiovascular (CV) pathophysiology and multiple non-CV comorbidities. We aimed to identify clinically important subgroups to improve our understanding of the pathophysiology of AHF and inform clinical decision-making. We evaluated detailed clinical data of 345 consecutive AHF patients using non-hierarchical cluster analysis of 77 variables, including age, sex, HF etiology, comorbidities, physical findings, laboratory data, electrocardiogram, echocardiogram and treatment during hospitalization. Cox proportional hazards regression analysis was performed to estimate the association between the clusters and clinical outcomes. Three clusters were identified. Cluster 1 (n=108) represented "vascular failure". This cluster had the highest average systolic blood pressure at admission and lung congestion with type 2 respiratory failure. Cluster 2 (n=89) represented "cardiac and renal failure". They had the lowest ejection fraction (EF) and worst renal function. Cluster 3 (n=148) comprised mostly older patients and had the highest prevalence of atrial fibrillation and preserved EF. Death or HF hospitalization within 12-month occurred in 23% of Cluster 1, 36% of Cluster 2 and 36% of Cluster 3 (p=0.034). Compared with Cluster 1, risk of death or HF hospitalization was 1.74 (95% CI, 1.03-2.95, p=0.037) for Cluster 2 and 1.82 (95% CI, 1.13-2.93, p=0.014) for Cluster 3. Cluster analysis may be effective in producing clinically relevant categories of AHF, and may suggest underlying pathophysiology and potential utility in predicting clinical outcomes. Copyright © 2018 Elsevier B.V. All rights reserved.

The Paradox of Pelvic Exenteration: The Interaction of Clinical and Psychological Variables.

PubMed

Arnaboldi, Paola; Santoro, Luigi; Mazzocco, Ketti; Oliveri, Serena; Maggioni, Angelo; Pravettoni, Gabriella

2015-10-01

To text the feasibility of a psychological intervention package administered to 49 pelvic exenteration candidates, aimed at evaluating the preoperative prevalence of psychological distress and assessing the presence of any correlation between preoperative psychological distress and clinical variables such as pain and hospitalization length. Patients were referred to the psychology unit from the very beginning of their clinical pathway and were administered the Psychological Distress Inventory (PDI) and the Mini-Mental Adjustment to Cancer (Mini-MAC) questionnaire at prehospital admission. Patients presenting with a significant level of distress received nonstandardized psychological support. Statistical analyses were performed to detect the presence of any correlation between psychological variables at prehospital admission and clinical outcomes. The 40% of patients had significant levels of distress at prehospital admission (PDI ≥ 30). As regards Mini-MAC, the mean value of fighting spirit attitude and fatalism was higher in our sample than in the normative sample of the Mini-MAC validation study in the Italian cancer population. Their anxious preoccupation attitude was lower. There were no correlations between clinical and psychological variables: level of postsurgery pain was higher (3.7) in the subgroup of patients with presurgery PDI < 30 compared with those with PDI ≥ 30 (3.5). However, this difference was not statistically significant (P = 1.00). Considering hospitalization length, the above described trend was similar. Although highly distressed, pelvic exenteration candidates show an adaptive range of coping mechanisms. This calls for a greater effort in studying the complexity of their psychoemotional status to provide them with the best multidisciplinary care. Extensive study of the real effectiveness of psychological intervention is warranted: randomized clinical trials could help in detecting the presence of any correlation between clinical and psychological variables in a multidisciplinary approach.

Between a bug and a hard place: Trypanosoma cruzi genetic diversity and the clinical outcomes of Chagas disease

PubMed Central

Messenger, Louisa A; Miles, Michael A; Bern, Caryn

2015-01-01

Over the last 30 years, concomitant with successful transnational disease control programs across Latin America, Chagas disease has expanded from a neglected, endemic parasitic infection of the rural poor to an urbanized chronic disease, and now a potentially emergent global health problem. Trypanosoma cruzi infection has a highly variable clinical course, ranging from complete absence of symptoms to severe and often fatal cardiovascular and/or gastrointestinal manifestations. To date, few correlates of clinical disease progression have been identified. Elucidating a putative role for T. cruzi strain diversity in Chagas disease pathogenesis is complicated by the scarcity of parasites in clinical specimens and the limitations of our contemporary genotyping techniques. This article systematically reviews the historical literature, given our current understanding of parasite genetic diversity, to evaluate the evidence for any association between T. cruzi genotype and chronic clinical outcome, risk of congenital transmission or reactivation and orally transmitted outbreaks. PMID:26162928

A Comparative Study of Nurses as Case Manager and Telephone Follow-up on Clinical Outcomes of Patients with Severe Mental Illness

PubMed Central

Malakouti, Seyed Kazem; Nojomi, Marzieh; Mirabzadeh, Arash; Mottaghipour, Yasaman; Zahiroddin, Alireza; Kangrani, Hamed Mohammadi

2016-01-01

Background: Providing community-based mental health services is crucial and is an agreed plan between the Iranian Mental Health Office and the Regional Committee for the Eastern Mediterranean (affiliated with WHO). The aim of this study was to determine the effectiveness of home-visit clinical case-management services on the hospitalization rate and other clinical outcomes in patients with severe mental illness. Methods: A total of 182 patients were randomly allocated into three groups, namely, home-visit (n=60), telephone follow-up (n=61) and as-usual care (n=61) groups. Trained nurses as clinical case-managers provided home-visit services and the telephone follow-up tasks. Hospitalization rate as a measure of recurrence, as well as burden, knowledge, general health condition of caregivers with positive/negative symptoms, satisfaction, quality of life, and social skills of the consumers were assessed as the main and secondary outcomes, respectively. Results: Most clinical variables were improved in both intervention groups compared with the control group. During the one year follow-up, the rate of rehospitalization for the telephone follow-up and as-usual groups were respectively 1.5 and 2.5 times higher than the home-visit group. Conclusion: Trained clinical case-managers are capable of providing continuous care services to patients with severe mental illness. The telephone follow-up services could also have beneficiary outcome for the consumers, their caregivers, and the health system network. PMID:26722141

[Structural Equation Modeling of Self-Management in Patients with Hemodialysis].

PubMed

Cha, Jieun

2017-02-01

The purpose of this study was to construct and test a hypothetical model of self-management in patients with hemodialysis based on the Self-Regulation Model and resource-coping perspective. Data were collected from 215 adults receiving hemodialysis in 17 local clinics and one tertiary hospital in 2016. The Hemodialysis Self-management Instrument, the Revised Illness Perception Questionnaire, Herth Hope Index and Multidimensional Scale of Perceived Social Support were used. The exogenous variable was social context; the endogenous variables were cognitive illness representation, hope, self-management behavior, and illness outcome. For data analysis, descriptive statistics, Pearson correlation analysis, factor analysis, and structural equation modeling were performed. The hypothetical model with six paths showed a good fitness to the empirical data: GFI=.96, AGFI=.90, CFI=.95, RMSEA=.08, SRMR=.04. The factors that had an influence on self-management behavior were social context (β=.84), hope and cognitive illness representation (β=.37 and β=.27) explaining 92.4% of the variance. Self-management behavior mediated the relationship between psychosocial coping resources and illness outcome. This research specifies a more complete spectrum of the self-management process. It is important to recognize the array of clinical resources available to support patients' self-management. Healthcare providers can facilitate self-management through collaborative care and understanding the ideas and emotions that each patient has about the illness, and ultimately improve the health outcomes. This framework can be used to guide self-management intervention development and assure effective clinical assessment. © 2017 Korean Society of Nursing Science

Clinical outcome of pediatric collagenous gastritis: case series and review of literature.

PubMed

Hijaz, Nadia Mazen; Septer, Seth Steven; Degaetano, James; Attard, Thomas Mario

2013-03-07

Collagenous gastritis (CG) is characterized by patchy subepithelial collagen bands. Effective treatment and the clinical and histological outcome of CG in children are poorly defined. The aim of this study is to summarize the published literature on the clinical outcome and response to therapy of pediatric CG including two new cases. We performed a search in Pubmed, OVID for related terms; articles including management and clinical and/or endo-histologic follow up information were included and abstracted. Reported findings were pooled in a dedicated database including the corresponding data extracted from chart review in our patients with CG. Twenty-four patients were included (17 females) with a mean age of 11.7 years. The clinical presentation included iron deficiency anemia and dyspepsia. The reported duration of follow up (in 18 patients) ranged between 0.2-14 years. Despite most subjects presenting with anemia including one requiring blood transfusion, oral iron therapy was only documented in 12 patients. Other treatment modalities were antisecretory measures in 13 patients; proton pump inhibitors (12), or histamine-2 blockers (3), sucralfate (5), prednisolone (6), oral budesonide in 3 patients where one received it in fish oil and triple therapy (3). Three (13%) patients showed no clinical improvement despite therapy; conversely 19 out of 22 were reported with improved symptoms including 8 with complete symptom resolution. Spontaneous clinical resolution without antisecretory, anti-inflammatory or gastroprotective agents was noted in 5 patients (4 received only supplemental iron). Follow up endo-histopathologic data (17 patients) included persistent collagen band and stable Mononuclear cell infiltrate in 12 patients with histopathologic improvement in 5 patients. Neither collagen band thickness nor mononuclear cell infiltrate correlated with clinical course. Intestinal metaplasia and endocrine cell hyperplasia were reported (1) raising the concern of long term malignant transformation. In summary, CG in children is a chronic disease, typically with a variable clinical response and an indolent course that is distinct from the adult phenotype. Long term therapy usually included iron supplementation but cannot be standardized, given the chronicity of the disease, variability of response and potential for adverse events.

Clinical outcome of pediatric collagenous gastritis: Case series and review of literature

PubMed Central

Hijaz, Nadia Mazen; Septer, Seth Steven; Degaetano, James; Attard, Thomas Mario

2013-01-01

Collagenous gastritis (CG) is characterized by patchy subepithelial collagen bands. Effective treatment and the clinical and histological outcome of CG in children are poorly defined. The aim of this study is to summarize the published literature on the clinical outcome and response to therapy of pediatric CG including two new cases. We performed a search in Pubmed, OVID for related terms; articles including management and clinical and/or endo-histologic follow up information were included and abstracted. Reported findings were pooled in a dedicated database including the corresponding data extracted from chart review in our patients with CG. Twenty-four patients were included (17 females) with a mean age of 11.7 years. The clinical presentation included iron deficiency anemia and dyspepsia. The reported duration of follow up (in 18 patients) ranged between 0.2-14 years. Despite most subjects presenting with anemia including one requiring blood transfusion, oral iron therapy was only documented in 12 patients. Other treatment modalities were antisecretory measures in 13 patients; proton pump inhibitors (12), or histamine-2 blockers (3), sucralfate (5), prednisolone (6), oral budesonide in 3 patients where one received it in fish oil and triple therapy (3). Three (13%) patients showed no clinical improvement despite therapy; conversely 19 out of 22 were reported with improved symptoms including 8 with complete symptom resolution. Spontaneous clinical resolution without antisecretory, anti-inflammatory or gastroprotective agents was noted in 5 patients (4 received only supplemental iron). Follow up endo-histopathologic data (17 patients) included persistent collagen band and stable Mononuclear cell infiltrate in 12 patients with histopathologic improvement in 5 patients. Neither collagen band thickness nor mononuclear cell infiltrate correlated with clinical course. Intestinal metaplasia and endocrine cell hyperplasia were reported (1) raising the concern of long term malignant transformation. In summary, CG in children is a chronic disease, typically with a variable clinical response and an indolent course that is distinct from the adult phenotype. Long term therapy usually inclused iron supplementation but cannot be standardized, given the chronicity of the disease, variability of response and potential for adverse events. PMID:23538318

LB01.06: VISIT-TO-VISIT BLOOD PRESSURE VARIABILITY AND CARDIOVASCULAR OUTCOMES IN FELODIPINE EVENT REDUCTION STUDY.

PubMed

Zhang, Y; Zhang, X; Liu, L; Zanchetti, A

2015-06-01

Many antihypertensive outcome trials have shown that visit-to-visit blood pressure variability is correlated closely with clinical outcomes in hypertensive patients. The objective of the study was to investigate the relationship between visit-to-visit blood pressure variability (BPV) and the major cardiovascular outcomes in the Chinese hypertensive patients. Felodipine Event Reduction (FEVER) study was a double-blind, randomized trial on 9711 Chinese hypertensive patients, in whom cardiovascular outcomes were significantly reduced by more intense therapy achieving a mean of 138 mmHg SBP compared with less-intense therapy achieving a mean of 142 mmHg. Visit-to-visit BPV during the follow-up period [defined as standard deviation (SD), coefficient of variation (CV), and average real variability(ARV)] was derived from casual cuff BP measures after six months follow-up until the end of the study. Hazard ratios (HRs), for the incidence of CVD associated with SD, CV, and ARV of SBP and DBP were calculated using Cox proportional hazard models. Overall predictive power [area under receiver operating characteristic (AUC ROC) curve] of the level of blood pressure, blood pressure variability and other baseline characteristics was calculated. In FEVER study, visit-to-visit variability in SBP were significant predictors of subsequent stroke [eg, hazard ratios [HR] for ARV, SD and CV was 1.071 (95% CI: 1.025-1.118), 1.373 (95% CI: 1.159-1.626) and 0.572 (95% CI: 0.451-0,726)]. Visit-to-visit variability in DBP were also showed similar trend [eg, HR for ARV, SD and CV was 1.066 (95% CI: 0.992-1.145), 1.931 (95% CI: 1.435-2.598) and 0.558 (95% CI: 0.438-0,710)]. However, using the analysis of AUC ROC analysis, the risk importance sequence of the stroke events in this cohort was level of SBP, age, level of DBP ARV, SD, sex, CV and treatment. Visit-to-visit blood pressure variability has some effects on the cardiovascular outcomes in the Chinese hypertensive patents in the cohort in FEVER Study. However, blood pressure per se is even more important for the development of stroke in this group of patients.

One year in review 2016: systemic lupus erythematosus.

PubMed

Adinolfi, Antonella; Valentini, Eleonora; Calabresi, Emanuele; Tesei, Giulia; Signorini, Viola; Barsotti, Simone; Tani, Chiara

2016-01-01

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with a highly variable course and prognosis. The management of the disease is still a clinical challenge for the treating physicians as many aspects regarding the disease pathogenesis, clinical picture and outcomes remain to be elucidated. New and interesting data are emerging; here the recent literature on SLE pathogenesis, clinical and laboratory aspects, as well as treatments and comorbidities, are reviewed and the main findings summarised in order to provide a bird's eye on the relevant papers on these topics.

Effect of the lymphocyte-to-monocyte ratio on the clinical outcome of chemotherapy administration in advanced melanoma patients.

PubMed

Leontovich, Alexey A; Dronca, Roxana S; Nevala, Wendy K; Thompson, Michael A; Kottschade, Lisa A; Ivanov, Leonid V; Markovic, Svetomir N

2017-02-01

Skin cancer affects more individuals in the USA than any other malignancy and malignant melanoma is particularly deadly because of its metastatic potential. Melanoma has been recognized as one of the most immunogenic malignancies; therefore, understanding the mechanisms of tumor-immune interaction is key for developing more efficient treatments. As the tumor microenvironment shows an immunosuppressive action, immunotherapeutic agents promoting endogenous immune response to cancer have been tested (interleukin-2, anticytotoxic-T-lymphocyte-associated antigen 4, and antiprogrammed cell death protein 1 monoclonal antibodies) as well as combinations of cytotoxic chemotherapy agents and inhibitors of angiogenesis (taxol/carboplatin/avastin). However, clinical outcomes are variable, with only a minority of patients achieving durable complete responses. The variability of immune homeostasis, which may be more active or more tolerant at any given time, in cancer patients and the interaction of the immune system with the tumor could explain the inconsistency in clinical outcomes among these patients. Recently, the role of the lymphocyte-to-monocyte-ratio (LMR) in the peripheral blood has been investigated and has been proven to be an independent predictor of survival in different hematological malignancies and in solid tumors. In melanoma, our group has validated the significance of LMR as a predictor of relapse after resection of advanced melanoma. In this study, we examined the dynamics in the immune system of patients with advanced melanoma by performing serial multiday concentration measurements of cytokines and immune cell subsets in the peripheral blood. The analysis of outcomes of chemotherapy administration as related to LMR on the day of treatment initiation showed that progression-free survival was improved in the patients who received chemotherapy on the day when LMR was elevated.

Longer dialysis session length is associated with better intermediate outcomes and survival among patients on in-center three times per week hemodialysis: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS)

PubMed Central

Tentori, Francesca; Zhang, Jinyao; Li, Yun; Karaboyas, Angelo; Kerr, Peter; Saran, Rajiv; Bommer, Juergen; Port, Friedrich; Akiba, Takashi; Pisoni, Ronald; Robinson, Bruce

2012-01-01

Background Longer dialysis session length (treatment time, TT) has been associated with better survival among hemodialysis (HD) patients. The impact of TT on clinical markers that may contribute to this survival advantage is not well known. Methods Using data from the international Dialysis Outcomes and Practice Patterns Study, we assessed the association of TT with clinical outcomes using both standard regression analyses and instrumental variable approaches. The study included 37 414 patients on in-center HD three times per week with prescribed TT from 120 to 420 min. Results Facility mean TT ranged from 214 min in the USA to 256 min in Australia–New Zealand. Accounting for country effects, mortality risk was lower for patients with longer TT {hazard ratio for every 30 min: all-cause mortality: 0.94 [95% confidence interval (CI): 0.92–0.97], cardiovascular mortality: 0.95 (95% CI: 0.91–0.98) and sudden death: 0.93 (95% CI: 0.88–0.98)}. Patients with longer TT had lower pre- and post-dialysis systolic blood pressure, greater intradialytic weight loss, higher hemoglobin (for the same erythropoietin dose), serum albumin and potassium and lower serum phosphorus and white blood cell counts. Similar associations were found using the instrumental variable approach, although the positive associations of TT with weight loss and potassium were lost. Conclusions Favorable levels of a variety of clinical markers may contribute to the better survival of patients receiving longer TT. These findings support longer TT prescription in the setting of in-center, three times per week HD. PMID:22431708

Predictors of pain and disability outcomes in one thousand, one hundred and eight patients who underwent lumbar discectomy surgery.

PubMed

Cook, Chad E; Arnold, Paul M; Passias, Peter G; Frempong-Boadu, Anthony K; Radcliff, Kristen; Isaacs, Robert

2015-11-01

A key component toward improving surgical outcomes is proper patient selection. Improved selection can occur through exploration of prognostic studies that identify variables which are associated with good or poorer outcomes with a specific intervention, such as lumbar discectomy. To date there are no guidelines identifying key prognostic variables that assist surgeons in proper patient selection for lumbar discectomy. The purpose of this study was to identify baseline characteristics that were related to poor or favourable outcomes for patients who undergo lumbar discectomy. In particular, we were interested in prognostic factors that were unique to those commonly reported in the musculoskeletal literature, regardless of intervention type. This retrospective study analysed data from 1,108 patients who underwent lumbar discectomy and had one year outcomes for pain and disability. All patient data was part of a multicentre, multi-national spine repository. Ten relatively commonly captured data variables were used as predictors for the study: (1) age, (2) body mass index, (3) gender, (4) previous back surgery history, (5) baseline disability, unique baseline scores for pain for both (6) low back and (7) leg pain, (8) baseline SF-12 Physical Component Summary (PCS) scores, (9) baseline SF-12 Mental Component Summary (MCS) scores, and (10) leg pain greater than back pain. Univariate and multivariate logistic regression analyses were run against one year outcome variables of pain and disability. For the multivariate analyses associated with the outcome of pain, older patients, those with higher baseline back pain, those with lesser reported disability and higher SF-12 MCS quality of life scores were associated with improved outcomes. For the multivariate analyses associated with the outcome of disability, presence of leg pain greater than back pain and no previous surgery suggested a better outcome. For this study, several predictive variables were either unique or conflicted with those advocated in general prognostic literature, suggesting they may have value for clinical decision making for lumbar discectomy surgery. In particular, leg pain greater than back pain and older age may yield promising value. Other significant findings such as quality of life scores and prior surgery may yield less value since these findings are similar to those that are considered to be prognostic regardless of intervention type.

Pure versus follicular variant of papillary thyroid carcinoma: clinical features, prognostic factors, treatment, and survival.

PubMed

Zidan, Jamal; Karen, Drumea; Stein, Moshe; Rosenblatt, Edward; Basher, Walid; Kuten, Abraham

2003-03-01

The follicular variant of papillary thyroid carcinoma (FVPTC) is a common subtype of papillary thyroid carcinoma. Few studies have compared the clinical behavior and treatment outcome of patients with FVPTC with the outcome of patients with pure papillary carcinoma (PTC). A retrospective study was performed to identify the influence of FVPTC compared with PTC on therapeutic variables, prognostic variables, and survival. A clinicopathologic analysis of 243 patients with papillary carcinoma was performed. One hundred forty-three tumors were PTC, and 100 tumors were FVPTC. The following variables were evaluated: age at diagnosis, tumor size, stage of tumor, treatment, capsular invasion, and survival. The median follow-up was 11.5 years. The median age was 43 years in the PTC group and 44 years in the FVPTC group. The median tumor size, disease stage, and type of initial surgery and iodine 131 ablation were similar. More patients had capsular invasion by the tumor and less metastases to cervical lymph nodes in the FVPTC group. The actuarial survival of patients age < 40 years was higher compared with the survival of patients age > 50 years in both groups. The 21-year overall actuarial survival was 82% in patients with PTC and 86% in patients with FVPTC (P value not significant). The pathologic and clinical behaviors of PTC and FVPTC were comparable. Prognostic factors, treatment, and survival also were similar. Patients in both groups must be treated identically. Copyright 2003 American Cancer Society.

What drives attitude towards telemedicine among families of pediatric patients? A survey.

PubMed

Russo, Luisa; Campagna, Ilaria; Ferretti, Beatrice; Agricola, Eleonora; Pandolfi, Elisabetta; Carloni, Emanuela; D'Ambrosio, Angelo; Gesualdo, Francesco; Tozzi, Alberto E

2017-01-17

Telemedicine has been recognized as a way to improve accessibility, quality, and efficiency of care. In view of the introduction of new telemedicine services, we conducted a survey through a self-administered questionnaire among families of children attending the Bambino Gesù Children's Hospital IRCCS, a tertiary care children's hospital located in Rome, Italy. We investigated sociodemographic data, clinical information, technological profile, attitude towards telemedicine, perceived advantages of telemedicine, fears regarding telemedicine, willingness to use a smartphone app providing telemedicine services and willingness to use a televisit service. Through logistic regression, we explored the effect of sociodemographic and clinical variables and technological profile on willingness of using a telemedicine app and a televisit service. We enrolled a total of 751 families. Most patients had a high technological profile, 81% had at least one account on a social network. Whatsapp was the most popular messaging service (76%). Seventy-two percent of patients would use an app for telemedicine services and 65% would perform a televisit. Owning a tablet was associated with both outcome variables - respectively: OR 2.216, 95% CI 1.358-3.616 (app) and OR 2.117, 95% CI 1.415-3.168 (televisit). Kind of hospitalization, diagnosis of a chronic disease, disease severity and distance from the health care center were not associated with the outcome variables. Families of pediatric patients with different clinical problems are keen to embark in telemedicine programs, independently from severity of disease or chronicity, and of distance from the hospital.

Prospective memory, level of disability, and return to work in severe mental illness.

PubMed

Burton, Cynthia Z; Vella, Lea; Twamley, Elizabeth W

2018-02-25

Prospective memory (the ability to remember to do things) has clear implications for everyday functioning, including employment, in people with severe mental illnesses (SMI). This study aimed to evaluate prospective memory performance and its relationship to real-world functional variables in an employment-seeking sample of people with SMI (Clinical Trial registration number NCT00895258). 153 individuals with DSM-IV diagnosis of depression (n = 58), bipolar disorder (n = 37), or schizophrenia (n = 58) who were receiving outpatient psychiatric care at a university clinic enrolled in a trial of supported employment and completed a baseline assessment. Prospective memory was measured with the Memory for Intentions Test (MIST); real-world functional status included work history variables, clinical history variables, baseline functional capacity (UCSD Performance-based Skills Assessment-Brief), and work outcomes (weeks worked and wages earned during two years of supported employment). Participants with schizophrenia performed worse on the MIST than did those with affective disorders. Independent of diagnosis, education, and estimated intellectual functioning, prospective memory significantly predicted variance in measures of disability and illness burden (disability benefits, hospitalization history, current functional capacity), and work outcomes over two years of supported employment (weeks worked). Worse prospective memory appears to be associated with greater illness burden and functional disability in SMI. Mental health clinicians and employment specialists may counsel clients to use compensatory prospective memory strategies to improve work performance and decrease functional disability associated with SMI.

Improved self-management skills predict improvements in quality of life and depression in patients with chronic disorders.

PubMed

Musekamp, Gunda; Bengel, Jürgen; Schuler, Michael; Faller, Hermann

2016-08-01

Self-management programs aim to improve patients' skills to manage their chronic condition in everyday life. Improvement in self-management is assumed to bring about improvements in more distal outcomes, such as quality of life. This study aimed to test the hypothesis that changes in self-reported self-management skills observed after participation in self-management programs predict changes in both quality of life and depressive symptoms three months later. Using latent change modeling, the relationship between changes in latent variables over three time points (start and end of rehabilitation, after three months) was analysed. The sample comprised 580 patients with different chronic conditions treated in inpatient rehabilitation clinics. The influence of additional predictor variables (age, sex, perceived social support) and type of disorder as a moderator variable was also tested. Changes in self-reported self-management skills after rehabilitation predicted changes in both quality of life and depressive symptoms at the end of rehabilitation and the 3 months follow-up. These relationships remained significant after the inclusion of other predictor variables and were similar across disorders. The findings provide support for the hypothesis that improvements in proximal outcomes of self-management programs may foster improvements in distal outcomes. Further studies should investigate treatment mechanisms. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Falsification Testing of Instrumental Variables Methods for Comparative Effectiveness Research.

PubMed

Pizer, Steven D

2016-04-01

To demonstrate how falsification tests can be used to evaluate instrumental variables methods applicable to a wide variety of comparative effectiveness research questions. Brief conceptual review of instrumental variables and falsification testing principles and techniques accompanied by an empirical application. Sample STATA code related to the empirical application is provided in the Appendix. Comparative long-term risks of sulfonylureas and thiazolidinediones for management of type 2 diabetes. Outcomes include mortality and hospitalization for an ambulatory care-sensitive condition. Prescribing pattern variations are used as instrumental variables. Falsification testing is an easily computed and powerful way to evaluate the validity of the key assumption underlying instrumental variables analysis. If falsification tests are used, instrumental variables techniques can help answer a multitude of important clinical questions. © Health Research and Educational Trust.

Impact of hospital atmosphere on perceived health care outcome.

PubMed

Narang, Ritu; Polsa, Pia; Soneye, Alabi; Fuxiang, Wei

2015-01-01

Healthcare service quality studies primarily examine the relationships between patients' perceived quality and satisfaction with healthcare services, clinical effectiveness, service use, recommendations and value for money. These studies suggest that patient-independent quality dimensions (structure, process and outcome) are antecedents to quality. The purpose of this paper is to propose an alternative by looking at the relationship between hospital atmosphere and healthcare quality with perceived outcome. Data were collected from Finland, India, Nigeria and the People's Republic of China. Regression analysis used perceived outcome as the dependent variable and atmosphere and healthcare service quality as independent variables. Findings - Results showed that atmosphere and healthcare service quality have a statistically significant relationship with patient perceived outcomes. The sample size was small and the sampling units were selected on convenience; thus, caution must be exercised in generalizing the findings. The study determined that service quality and atmosphere are considered significant for developing and developed nations. This result could have significant implications for policy makers and service providers developing healthcare quality and hospital atmosphere. Studies concentrate on healthcare outcome primarily regarding population health status, mortality, morbidity, customer satisfaction, loyalty, quality of life, customer behavior and consumption. However, the study exposes how patients perceive their health after treatment. Furthermore, the authors develop the healthcare service literature by considering atmosphere and perceived outcome.

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.

Influence of social support on health-related quality of life outcomes in head and neck cancer.

PubMed

Karnell, Lucy Hynds; Christensen, Alan J; Rosenthal, Eben L; Magnuson, J Scott; Funk, Gerry F

2007-02-01

Evidence that social support influences health-related quality of life (HRQOL) in oncologic patients could be particularly important for head and neck cancer because this disease can affect speech, eating, and facial aesthetics. Multiple regression analyses were used in this prospective, observational study to determine the association between 394 patients' ratings of perceived post-treatment social support and HRQOL outcomes while controlling for possible confounding variables. Higher social support scores were significantly associated with higher scores in speech (p = .007), aesthetics (p = .015), social disruption (p = .045), and general mental health (p = .016) and with fewer depressive symptoms (p = .023) but not with general physical health (p = .191) or eating (p = .114). The magnitude of differences in the HRQOL outcomes for patients whose social support scores fell in the lowest and highest quartiles were clinically meaningful. Given the association between social support and HRQOL outcomes in this patient population, modification of perceived social support through clinical interventions could improve the survivorship of these patients.

Assessment in health psychology: Introduction to the special issue.

PubMed

Butt, Zeeshan

2016-09-01

For the past 27 years, Psychological Assessment has been committed to publishing empirical research relevant to clinical assessment of basic and applied cognition, personality, interpersonal behavior, psychopathology, forensics, and biological psychology. There is growing interest in the use of patient-centered outcomes in medical/surgical care and for measuring health care performance. Patient-centered outcome measures complement traditional clinical outcomes of morbidity and mortality, capturing the patient’s perspective regarding their health and its treatment. In this issue, we highlight 11 articles that address different aspects of such work. The articles in this special issue represent both the depth and breadth of the opportunities that exist for psychological assessment in the health setting. While there are countless patient-centered measures currently in use to measure health and health outcomes, the evidence base for their use can be quite variable (Butt, 2016). The hope is that future issues of Psychological Assessment will highlight more work in this area. PsycINFO Database Record (c) 2016 APA, all rights reserved

Measuring and communicating meaningful outcomes in neonatology: A family perspective.

PubMed

Janvier, Annie; Farlow, Barbara; Baardsnes, Jason; Pearce, Rebecca; Barrington, Keith J

2016-12-01

Medium- and long-term outcomes have been collected and described among survivors of neonatal intensive care units for decades, for a number of purposes: (1) quality control within units, (2) comparisons of outcomes between NICUs, (3) clinical trials (whether an intervention improves outcomes), (4) end-of-life decision-making, (5) to better understand the effects of neonatal conditions and/or interventions on organs and/or long-term health, and finally (6) to better prepare parents for the future. However, the outcomes evaluated have been selected by investigators, based on feasibility, availability, cost, stability, and on what investigators consider to be important. Many of the routinely measured outcomes have major limitations: they may not correlate well with long-term difficulties, they may artificially divide continuous outcomes into dichotomous ones, and may have no clear relationship with quality of life and functioning of children and their families. Several investigations, such as routine term cerebral resonance imaging for preterm infants, have also not yet been shown to improve the outcome of children nor their families. In this article, the most common variables used in neonatology as well as some variables which are rarely measured but may be of equal importance for families are presented. The manner in which these outcomes are communicated to families will be examined, as well as recommendations to optimize communication with parents. Copyright © 2016 Elsevier Inc. All rights reserved.

Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA.

PubMed

Smith, Wade S; Lev, Michael H; English, Joey D; Camargo, Erica C; Chou, Maggie; Johnston, S Claiborne; Gonzalez, Gilberto; Schaefer, Pamela W; Dillon, William P; Koroshetz, Walter J; Furie, Karen L

2009-12-01

Acute ischemic stroke due to large vessel occlusion (LVO)-vertebral, basilar, carotid terminus, middle and anterior cerebral arteries-likely portends a worse prognosis than stroke unassociated with LVO. Because little prospective angiographic data have been reported on a cohort of unselected patients with stroke and with transient ischemic attack, the clinical impact of LVO has been difficult to quantify. The Screening Technology and Outcome Project in Stroke Study is a prospective imaging-based study of stroke outcomes performed at 2 academic medical centers. Patients with suspected acute stroke who presented within 24 hours of symptom onset and who underwent multimodality CT/CT angiography were approached for consent for collection of clinical data and 6-month assessment of outcome. Demographic and clinical variables and 6-month modified Rankin Scale scores were collected and combined with blinded interpretation of the CT angiography data. The OR of each variable, including occlusion of intracranial vascular segment in predicting good outcome and 6-month mortality, was calculated using univariate and multivariate logistic regression. Over a 33-month period, 735 patients with suspected stroke were enrolled. Of these, 578 were adjudicated as stroke and 97 as transient ischemic attack. Among patients with stroke, 267 (46%) had LVO accounting for the stroke and 13 (13%) of patients with transient ischemic attack had LVO accounting for transient ischemic attack symptoms. LVO predicted 6-month mortality (OR, 4.5; 95% CI, 2.7 to 7.3; P<0.001). Six-month good outcome (modified Rankin Scale score

Integrating mindfulness in supportive cancer care: a cohort study on a mindfulness-based day care clinic for cancer survivors.

PubMed

Dobos, Gustav; Overhamm, Tatiana; Büssing, Arndt; Ostermann, Thomas; Langhorst, Jost; Kümmel, Sherko; Paul, Anna; Cramer, Holger

2015-10-01

The aim of this study was to investigate the effects of a mindfulness-based day care clinic group program for cancer survivors on health-related quality of life and mental health; and to investigate which psychological variables are associated with changes in health variables. One hundred seventeen cancer survivors (91.0 % female; mean age 53.9 ± 10.7 years; 65.0 % breast cancer; mean time since diagnosis 27.2 ± 46.5 months) participated in an 11-week mindfulness-based day care clinic group program, 6 h per week. The intervention incorporated mindfulness-based meditation, yoga, cognitive-behavioral techniques, and lifestyle modification. Outcome measures including health-related quality of life (EORTC QLQ-C30), depression and anxiety (HADS); and psychological variables including life satisfaction (BMLSS), mindfulness (FMI), adaptive coping styles (AKU), spiritual/religious attitudes in dealing with illness (SpREUK), and interpretation of illness (IIQ) were assessed before, after, and 3 months after the intervention. Using mixed linear models, significant improvements in global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning were found. Cancer-related symptoms, including fatigue, pain, insomnia, constipation, anxiety, and depression, also improved significantly. Mindfulness, life satisfaction, health satisfaction, all coping styles, all spiritual/religious attitudes, and interpretation of illness as something of value increased; interpretation of illness as punishment decreased significantly (all p < 0.05). Improved outcomes were associated with increases in psychological variables, mainly life satisfaction, health satisfaction, and trust in medical help (R (2) = 7.3-43.6 %). Supportive mindfulness-based interventions can be considered as an effective means to improve cancer survivors' physical and mental health. Functional improvements are associated with improved satisfaction and coping styles.

Responses to clinical uncertainty in Australian general practice trainees: a cross-sectional analysis.

PubMed

Cooke, Georga; Tapley, Amanda; Holliday, Elizabeth; Morgan, Simon; Henderson, Kim; Ball, Jean; van Driel, Mieke; Spike, Neil; Kerr, Rohan; Magin, Parker

2017-12-01

Tolerance for ambiguity is essential for optimal learning and professional competence. General practice trainees must be, or must learn to be, adept at managing clinical uncertainty. However, few studies have examined associations of intolerance of uncertainty in this group. The aim of this study was to establish levels of tolerance of uncertainty in Australian general practice trainees and associations of uncertainty with demographic, educational and training practice factors. A cross-sectional analysis was performed on the Registrar Clinical Encounters in Training (ReCEnT) project, an ongoing multi-site cohort study. Scores on three of the four independent subscales of the Physicians' Reaction to Uncertainty (PRU) instrument were analysed as outcome variables in linear regression models with trainee and practice factors as independent variables. A total of 594 trainees contributed data on a total of 1209 occasions. Trainees in earlier training terms had higher scores for 'Anxiety due to uncertainty', 'Concern about bad outcomes' and 'Reluctance to disclose diagnosis/treatment uncertainty to patients'. Beyond this, findings suggest two distinct sets of associations regarding reaction to uncertainty. Firstly, affective aspects of uncertainty (the 'Anxiety' and 'Concern' subscales) were associated with female gender, less experience in hospital prior to commencing general practice training, and graduation overseas. Secondly, a maladaptive response to uncertainty (the 'Reluctance to disclose' subscale) was associated with urban practice, health qualifications prior to studying medicine, practice in an area of higher socio-economic status, and being Australian-trained. This study has established levels of three measures of trainees' responses to uncertainty and associations with these responses. The current findings suggest differing 'phenotypes' of trainees with high 'affective' responses to uncertainty and those reluctant to disclose uncertainty to patients. More research is needed to examine the relationship between clinical uncertainty and clinical outcomes, temporal changes in tolerance for uncertainty, and strategies that might assist physicians in developing adaptive responses to clinical uncertainty. © 2017 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Clinical status, quality of life, and work productivity in Crohn's disease patients after one year of treatment with adalimumab.

PubMed

Saro, Cristina; Ceballos, Daniel; Muñoz, Fernando; de la Coba, Cristóbal; Aguilar, María Dolores; Lázaro, Pablo; García-Sánchez, Valle; Hernández, Mariola; Barrio, Jesús; de Francisco, Ruth; Fernández, Luis I; Barreiro-de Acosta, Manuel

2017-02-01

Clinical trials have shown the efficacy of adalimumab in Crohn's disease, but the outcome in regular practice remains unknown. The aim of the study was to examine clinical status, quality of life, and work productivity of Crohn's disease patients receiving adalimumab for one year in the context of usual clinical practice. This was a prospective, observational study with a one-year follow-up. After baseline, Crohn's disease patients were evaluated at 1, 3, 6, 9, and 12 months after starting treatment with adalimumab. Outcome variables included: clinical status (measured with CDAI), quality of life (measured with EuroQoL-5D and IBDQ), and work productivity (measured with WPAI questionnaire). These outcome variables were compared using the Student's t test or Wilcoxon test for paired comparison data according to the data distribution. Statistical significance was set at two-sided p < 0.05. The sample was composed of 126 patients (age [mean] 39.1 ± [standard deviation] 13.8 years; 51% male). Significant changes were observed during the follow-up period: CDAI decreased from [median] 194 ([25-75 percentiles] 121-269) to 48.2 (10.1-122.0) (p < 0.05); the EuroQoL-5D increased from 0.735 (0.633-0.790) to 0.797 (0.726-1.000) (p < 0.05); the EuroQoL-5D visual analogue scale increased from 50.0 (40-70) to 80.0 (60-90); (p < 0.05) and the IBDQ increased from 56.7 (51.6-61.5) to 67.5 (60.1-73.6) (p < 0.05). The total work productivity impact decreased from 53% to 24% (p < 0.05). In regular practice, adalimumab is clinically effective in the treatment of Crohn's disease patients and results in a significant improvement in quality of life and work productivity.

Vascular Glucose Sensor Symposium: Continuous Glucose Monitoring Systems (CGMS) for Hospitalized and Ambulatory Patients at Risk for Hyperglycemia, Hypoglycemia, and Glycemic Variability.

PubMed

Joseph, Jeffrey I; Torjman, Marc C; Strasma, Paul J

2015-07-01

Hyperglycemia, hypoglycemia, and glycemic variability have been associated with increased morbidity, mortality, length of stay, and cost in a variety of critical care and non-critical care patient populations in the hospital. The results from prospective randomized clinical trials designed to determine the risks and benefits of intensive insulin therapy and tight glycemic control have been confusing; and at times conflicting. The limitations of point-of-care blood glucose (BG) monitoring in the hospital highlight the great clinical need for an automated real-time continuous glucose monitoring system (CGMS) that can accurately measure the concentration of glucose every few minutes. Automation and standardization of the glucose measurement process have the potential to significantly improve BG control, clinical outcome, safety and cost. © 2015 Diabetes Technology Society.

Preoperative Electrocardiogram Score for Predicting New-Onset Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery.

PubMed

Gu, Jiwei; Andreasen, Jan J; Melgaard, Jacob; Lundbye-Christensen, Søren; Hansen, John; Schmidt, Erik B; Thorsteinsson, Kristinn; Graff, Claus

2017-02-01

To investigate if electrocardiogram (ECG) markers from routine preoperative ECGs can be used in combination with clinical data to predict new-onset postoperative atrial fibrillation (POAF) following cardiac surgery. Retrospective observational case-control study. Single-center university hospital. One hundred consecutive adult patients (50 POAF, 50 without POAF) who underwent coronary artery bypass grafting, valve surgery, or combinations. Retrospective review of medical records and registration of POAF. Clinical data and demographics were retrieved from the Western Denmark Heart Registry and patient records. Paper tracings of preoperative ECGs were collected from patient records, and ECG measurements were read by two independent readers blinded to outcome. A subset of four clinical variables (age, gender, body mass index, and type of surgery) were selected to form a multivariate clinical prediction model for POAF and five ECG variables (QRS duration, PR interval, P-wave duration, left atrial enlargement, and left ventricular hypertrophy) were used in a multivariate ECG model. Adding ECG variables to the clinical prediction model significantly improved the area under the receiver operating characteristic curve from 0.54 to 0.67 (with cross-validation). The best predictive model for POAF was a combined clinical and ECG model with the following four variables: age, PR-interval, QRS duration, and left atrial enlargement. ECG markers obtained from a routine preoperative ECG may be helpful in predicting new-onset POAF in patients undergoing cardiac surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

The role of androgen receptor CAG repeat polymorphism and other factors which affect the clinical response to testosterone replacement in metabolic syndrome and type 2 diabetes: TIMES2 sub-study.

PubMed

Stanworth, R D; Akhtar, S; Channer, K S; Jones, T H

2014-02-01

The TIMES2 (testosterone replacement in hypogonadal men with either metabolic syndrome or type 2 diabetes) study reported beneficial effects of testosterone replacement therapy (TRT) on insulin resistance and other variables in men with diabetes or metabolic syndrome. The androgen receptor CAG repeat polymorphism (AR CAG) is known to affect stimulated AR activity and has been linked to various clinically relevant variables. To assess the role of AR CAG in the alteration of clinical response to TRT in the TIMES2 study. Subgroup analysis from a multicentre, randomised, double-blind, placebo-controlled and parallel group study. Outpatient study recruiting from secondary and primary care. A total of 139 men with hypogonadism and type 2 diabetes or metabolic syndrome, of which 73 received testosterone during the TIMES2 study. Testosterone 2% transdermal gel vs placebo. Regression coefficient of AR CAG from linear regression models for each variable. AR CAG was independently positively associated with change in fasting insulin, triglycerides and diastolic blood pressure during TRT with a trend to association with HOMA-IR - the primary outcome variable. There was a trend to negative association between AR CAG and change in PSA. There was no association of AR CAG with change in other glycaemic variables, other lipid variables or obesity. AR CAG affected the response of some variables to TRT in the TIMES2 study, although the association with HOMA-IR did not reach significance. Various factors may have limited the power of our study to detect the significant associations between AR CAG, testosterone levels and change in variables with testosterone treatment. Analysis of similar data sets from other clinical trials is warranted.

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.

PubMed

Earley, Amy; Lau, Joseph; Uhlig, Katrin

2013-01-18

A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Registry-based study of clinical trial results reporting. ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.

The prognostic impact of clinical and CT parameters in patients with pontine hemorrhage.

PubMed

Dziewas, Rainer; Kremer, Marion; Lüdemann, Peter; Nabavi, Darius G; Dräger, Bianca; Ringelstein, Bernd

2003-01-01

In patients with pontine hemorrhage (PH), an accurate prognostic assessment is critical for establishing a reasonable therapeutic approach. The initial clinical symptoms and computed tomography (CT) features were analyzed with multivariate regression analysis in 39 consecutive patients with PH. PHs were classified into three types: (1) large paramedian, (2) basal or basotegmental and (3) lateral tegmental, and the hematomas' diameters were measured. The patients' outcome was evaluated. Twenty-seven patients (69%) died and 12 (31%) survived for more than 1 year after PH. The symptom most predictive of death was coma on admission. The large paramedian type of PH predicted a poor prognosis, whereas the lateral tegmental type was associated with a favorable outcome. The transverse hematoma diameter was also related to outcome, with the threshold value found to be 20 mm. We conclude that PH outcome can be estimated best by combining the CT parameters 'large paramedian PH' and 'transverse diameter >/=20 mm' with the clinical variable 'coma on admission'. Survival is unlikely if all 3 features are present, whereas survival may be expected if only 1 or none of these features is found. Copyright 2003 S. Karger AG, Basel

Intracardiac impedance response during acute AF internal cardioversion using novel rectilinear and capacitor-discharge waveforms.

PubMed

Rababah, A S; Walsh, S J; Manoharan, G; Walsh, P R; Escalona, O J

2016-07-01

Intracardiac impedance (ICI) is a major determinant of success during internal cardioversion of atrial fibrillation (AF). However, there have been few studies that have examined the dynamic behaviour of atrial impedance during internal cardioversion in relation to clinical outcome. In this study, voltage and current waveforms captured during internal cardioversion of acute AF in ovine models using novel radiofrequency (RF) generated low-tilt rectilinear and conventional capacitor-discharge based shock waveforms were retrospectively analysed using a digital signal processing algorithm to investigate the dynamic behaviour of atrial impedance during cardioversion. The algorithm was specifically designed to facilitate the simultaneous analysis of multiple impedance parameters, including: mean intracardiac impedance (Z M), intracardiac impedance variance (ICIV) and impedance amplitude spectrum area (IAMSA) for each cardioversion event. A significant reduction in ICI was observed when comparing two successive shocks of increasing energy where cardioversion outcome was successful. In addition, ICIV and IAMSA variables were found to inversely correlate to the magnitude of energy delivered; with a stronger correlation found to the former parameter. In conclusion, ICIV and IAMSA have been evidenced as two key dynamic intracardiac impedance variables that may prove useful in better understanding of the cardioversion process and that could potentially act as prognostic markers with respect to clinical outcome.

Short-Term Outcomes of Minimally Invasive Esophagectomy for Carcinoma In Patients with Liver Cirrhosis.

PubMed

Sozzi, Marco; Siboni, Stefano; Asti, Emanuele; Bonitta, Gianluca; Bonavina, Luigi

2017-06-01

Open esophagectomy is a high-risk procedure in patients with liver cirrhosis. With the advent of minimally invasive surgical techniques, the overall morbidity and mortality rates of esophagectomy have decreased. The aim of this study was to describe short-term outcomes of minimally invasive esophagectomy in patients with proven liver cirrhosis. Retrospective observational cohort study. Demographics, preoperative clinical characteristics, and outcomes of patients undergoing minimally invasive esophagectomy for carcinoma were analyzed. Patients with concomitant liver cirrhosis were compared to patients without liver cirrhosis undergoing similar surgical procedures. In addition, variables possibly associated with postoperative morbidity and mortality in patients with cirrhosis were investigated. Out of 443 patients undergoing minimally invasive esophagectomy, 18 (4.1%) had concomitant liver cirrhosis. Demographics and preoperative clinical variables were similar in the 2 patient groups. While the overall morbidity rate was similar, the 90-day mortality rate was significantly higher in patients with liver cirrhosis (P = .023). There was a significantly higher rate of sepsis and anastomotic, respiratory, and hemorrhagic complications in patients with liver cirrhosis who died in the postoperative period. Minimally invasive esophagectomy is feasible in patients with liver cirrhosis. Future strategies should focus on total minimally invasive procedures and early recognition of surgical complications.

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.

Is electromyography a predictive test of patient response to biofeedback in the treatment of fecal incontinence?

PubMed

Lacima, Gloria; Pera, Miguel; González-Argenté, Xavier; Torrents, Abiguei; Valls-Solé, Josep; Espuña-Pons, Montserrat

2016-03-01

Biofeedback is effective in more than 70% of patients with fecal incontinence. However, reliable predictors of successful treatment have not been identified. The aim was to identify clinical variables and diagnostic tests, particularly electromyography, that could predict a successful outcome. We included 135 consecutive women with fecal incontinence treated with biofeedback. Clinical evaluation, manometry, ultrasonography, electromyography, and pudendal nerve terminal motor latency were performed before therapy. Treatment outcome was assessed using a symptoms diary, Wexner incontinence score and the patient's subjective perception. According to the symptoms diaries, 106 (78.5%) women had a good clinical result and 29 (21.5%) had a poor result. There were no differences in age, severity and type of fecal incontinence. Maximum resting pressure (39.3 ± 19.1 mmHg vs. 33.7 ± 20.2 mmHg; P = 0.156) and maximum squeeze pressure (91.8 ± 33.2 mmHg vs. 79.8 ± 31.2 mmHg; P = 0.127) were higher in patients having good clinical outcome although the difference was not significant. There were no differences in the presence of sphincter defects or abnormalities in electromyographic recordings. Logistic regression analysis found no independent predictive factor for good clinical outcome. Biofeedback is effective in more than 75% of patients with fecal incontinence. Clinical characteristics of patients and results of baseline tests have no predictive value of response to therapy. Specifically, we found no association between severity of electromyographic deficit and clinical response. © 2015 Wiley Periodicals, Inc.

PRION-1 scales analysis supports use of functional outcome measures in prion disease

PubMed Central

Mead, S.; Ranopa, M.; Gopalakrishnan, G.S.; Thompson, A.G.B.; Rudge, P.; Wroe, S.; Kennedy, A.; Hudson, F.; MacKay, A.; Darbyshire, J.H.; Walker, A.S.

2011-01-01

Objectives: Human prion diseases are heterogeneous but invariably fatal neurodegenerative disorders with no known effective therapy. PRION-1, the largest clinical trial in prion disease to date, showed no effect of the potential therapeutic quinacrine on survival. Although there are several limitations to the usefulness of survival as an outcome measure, there have been no comprehensive studies of alternatives. Methods: To address this we did comparative analyses of neurocognitive, psychiatric, global, clinician-rated, and functional scales, focusing on validity, variability, and impact on statistical power over 77 person-years follow-up in 101 symptomatic patients in PRION-1. Results: Quinacrine had no demonstrable benefit on any of the 8 scales (p > 0.4). All scales had substantial numbers of patients with the worst possible score at enrollment (Glasgow Coma Scale score being least affected) and were impacted by missing data due to disease progression. These effects were more significant for cognitive/psychiatric scales than global, clinician-rated, or functional scales. The Barthel and Clinical Dementia Rating scales were the most valid and powerful in simulated clinical trials of an effective therapeutic. A combination of selected subcomponents from these 2 scales gave somewhat increased power, compared to use of survival, to detect clinically relevant effects in future clinical trials of feasible size. Conclusions: Our findings have implications for the choice of primary outcome measure in prion disease clinical trials. Prion disease presents the unusual opportunity to follow patients with a neurodegenerative disease through their entire clinical course, and this provides insights relevant to designing outcome measures in related conditions. PMID:22013183

Stromal cell markers are differentially expressed in the synovial tissue of patients with early arthritis.

PubMed

Choi, Ivy Y; Karpus, Olga N; Turner, Jason D; Hardie, Debbie; Marshall, Jennifer L; de Hair, Maria J H; Maijer, Karen I; Tak, Paul P; Raza, Karim; Hamann, Jörg; Buckley, Christopher D; Gerlag, Danielle M; Filer, Andrew

2017-01-01

Previous studies have shown increased expression of stromal markers in synovial tissue (ST) of patients with established rheumatoid arthritis (RA). Here, ST expression of stromal markers in early arthritis in relationship to diagnosis and prognostic outcome was studied. ST from 56 patients included in two different early arthritis cohorts and 7 non-inflammatory controls was analysed using immunofluorescence to detect stromal markers CD55, CD248, fibroblast activation protein (FAP) and podoplanin. Diagnostic classification (gout, psoriatic arthritis, unclassified arthritis (UA), parvovirus associated arthritis, reactive arthritis and RA), disease outcome (resolving vs persistent) and clinical variables were determined at baseline and after follow-up, and related to the expression of stromal markers. We observed expression of all stromal markers in ST of early arthritis patients, independent of diagnosis or prognostic outcome. Synovial expression of FAP was significantly higher in patients developing early RA compared to other diagnostic groups and non-inflammatory controls. In RA FAP protein was expressed in both lining and sublining layers. Podoplanin expression was higher in all early inflammatory arthritis patients than controls, but did not differentiate diagnostic outcomes. Stromal marker expression was not associated with prognostic outcomes of disease persistence or resolution. There was no association with clinical or sonographic variables. Stromal cell markers CD55, CD248, FAP and podoplanin are expressed in ST in the earliest stage of arthritis. Baseline expression of FAP is higher in early synovitis patients who fulfil classification criteria for RA over time. These results suggest that significant fibroblast activation occurs in RA in the early window of disease.

Does socioeconomic status predict course and outcome in patients with psychosis?

PubMed

Samele, C; van Os, J; McKenzie, K; Wright, A; Gilvarry, C; Manley, C; Tattan, T; Murray, R

2001-12-01

We examined the relationship between socioeconomic status (SES) and course and outcome of patients with psychosis. Two hypotheses were examined: a) patients with higher best-ever SES will have better course and outcome than those with lower best-ever SES, and b) patients with greater downward drift in SES will have poorer course and outcome than those with less downward drift. Data were drawn from the baseline and 2-year follow-up assessments of the UK700 Case Management Trial of 708 patients with severe psychosis. The indicators of SES used were occupational status and educational achievement. Drift in SES was defined as change from best-ever occupation to occupation at baseline. For the baseline data highly significant differences were found between best-ever groups and negative symptoms (non-manual vs. unemployed--coef -10.5, p=0.000, 95% CIs 5.1-15.8), functioning (non-manual vs. unemployed--coef -0.6, p=0.000, 95% CIs 0.3 to -0.8) and unmet needs (manual vs. unemployed - coef 0.5, p=0.004, 95% CIs 0.2-0.9). No significant differences between best-ever groups were found for days in hospital, symptoms, perceived quality of life and dissatisfaction with services. Significant differences for clinical and social variables were found between drift and non-drift SES groups. There were no significant findings between educational groups and clinical and social variables. Best-ever occupation, but not educational qualifications, appeared to predict prognosis in patients with severe psychosis. Downward drift in occupational status did not result in poorer illness course and outcome.

A tool for prediction of risk of rehospitalisation and mortality in the hospitalised elderly: secondary analysis of clinical trial data

PubMed Central

Alassaad, Anna; Melhus, Håkan; Hammarlund-Udenaes, Margareta; Bertilsson, Maria; Gillespie, Ulrika; Sundström, Johan

2015-01-01

Objectives To construct and internally validate a risk score, the ‘80+ score’, for revisits to hospital and mortality for older patients, incorporating aspects of pharmacotherapy. Our secondary aim was to compare the discriminatory ability of the score with that of three validated tools for measuring inappropriate prescribing: Screening Tool of Older Person's Prescriptions (STOPP), Screening Tool to Alert doctors to Right Treatment (START) and Medication Appropriateness Index (MAI). Setting Two acute internal medicine wards at Uppsala University hospital. Patient data were used from a randomised controlled trial investigating the effects of a comprehensive clinical pharmacist intervention. Participants Data from 368 patients, aged 80 years and older, admitted to one of the study wards. Primary outcome measure Time to rehospitalisation or death during the year after discharge from hospital. Candidate variables were selected among a large number of clinical and drug-specific variables. After a selection process, a score for risk estimation was constructed. The 80+ score was internally validated, and the discriminatory ability of the score and of STOPP, START and MAI was assessed using C-statistics. Results Seven variables were selected. Impaired renal function, pulmonary disease, malignant disease, living in a nursing home, being prescribed an opioid or being prescribed a drug for peptic ulcer or gastroesophageal reflux disease were associated with an increased risk, while being prescribed an antidepressant drug (tricyclic antidepressants not included) was linked to a lower risk of the outcome. These variables made up the components of the 80+ score. The C-statistics were 0.71 (80+), 0.57 (STOPP), 0.54 (START) and 0.63 (MAI). Conclusions We developed and internally validated a score for prediction of risk of rehospitalisation and mortality in hospitalised older people. The score discriminated risk better than available tools for inappropriate prescribing. Pending external validation, this score can aid in clinical identification of high-risk patients and targeting of interventions. PMID:25694461

Cerebrospinal Fluid Biomarkers and Reserve Variables as Predictors of Future “Non-Cognitive” Outcomes of Alzheimer’s Disease

PubMed Central

Ingber, Adam P.; Hassenstab, Jason; Fagan, Anne M.; Benzinger, Tammie L.S.; Grant, Elizabeth A.; Holtzman, David M.; Morris, John C.; Roe, Catherine M.

2016-01-01

Background The influence of reserve variables and Alzheimer’s disease (AD) biomarkers on cognitive test performance has been fairly well-characterized. However, less is known about the influence of these factors on “non-cognitive” outcomes, including functional abilities and mood. Objective We examined whether cognitive and brain reserve variables mediate how AD biomarker levels in cognitively normal persons predict future changes in function, mood, and neuropsychiatric behavior. Methods Non-cognitive outcomes were examined in 328 individuals 50 years and older enrolled in ongoing studies of aging and dementia at the Knight Alzheimer Disease Research Center (ADRC). All participants were cognitively normal at baseline (Clinical Dementia Rating [CDR] 0), completed cerebrospinal fluid (CSF) and structural neuroimaging studies within one year of baseline, and were followed for an average of 4.6 annual visits. Linear mixed effects models explored how cognitive reserve and brain reserve variables mediate the relationships between AD biomarker levels and changes in function, mood, and neuropsychiatric behavior in cognitively normal participants. Results Education levels did not have a significant effect on predicting non-cognitive decline. However, participants with smaller brain volumes exhibited the worst outcomes on measures of mood, functional abilities, and behavioral disturbance. This effect was most pronounced in individuals who also had abnormal CSF biomarkers. Conclusions The findings suggest that brain reserve plays a stronger, or earlier, role than cognitive reserve in protecting against non-cognitive impairment in AD. PMID:27104893

Predicting functional remission in patients with schizophrenia: a cross-sectional study of symptomatic remission, psychosocial remission, functioning, and clinical outcome

PubMed Central

Valencia, Marcelo; Fresán, Ana; Barak, Yoram; Juárez, Francisco; Escamilla, Raul; Saracco, Ricardo

2015-01-01

Background New approaches to assess outcome in schizophrenia include multidimensional measures such as remission, cognition, psychosocial functioning, and quality of life. Clinical and psychosocial measures have been recently introduced to assess functional outcome. Objective The study presented here was designed to examine the rates of symptomatic remission, psychosocial remission, global functioning, and clinical global impressions in a sample of schizophrenia outpatients in order to assess functional remission and to identify predictive factors for functional remission. Methods A total of 168 consecutive Mexican outpatients receiving pharmacological treatment at the National Institute of Psychiatry in Mexico City were enrolled in a cross-sectional study. Symptomatic remission was assessed according to the definition and criteria proposed by the Remission in Schizophrenia Working Group using the Positive and Negative Symptom Scale. Psychosocial remission was assessed according to Barak criteria using the Psychosocial Remission in Schizophrenia scale. Functioning was measured with the Global Assessment of Functioning, and clinical outcome with the Clinical Global Impressions (CGI) Scale. Results Findings showed that 45.2% of patients fulfilled the symptomatic remission criteria, 32.1% achieved psychosocial remission, and 53% reported adequate functioning. However, the combination of these three outcome criteria – symptomatic, psychosocial remission, and functioning – indicated that 14.9% of the patients achieved our predefined functional remission outcome. The logistic regression model included five predictive variables for functional remission: (1) being employed, (2) use of atypical antipsychotics, (3) lower number of medications, (4) lower negative symptom severity, and (5) lower excitement symptom severity. Conclusion The study demonstrated that symptomatic remission, psychosocial remission, and functioning could be achievable goals for a considerable number of patients. The outcome of functional remission was achieved by a minority of patients, less than 15%. New approaches should include multidimensional measures to assess functional outcome in schizophrenia research. PMID:26396518

Molecular Classification Substitutes for the Prognostic Variables Stage, Age, and MYCN Status in Neuroblastoma Risk Assessment.

PubMed

Rosswog, Carolina; Schmidt, Rene; Oberthuer, André; Juraeva, Dilafruz; Brors, Benedikt; Engesser, Anne; Kahlert, Yvonne; Volland, Ruth; Bartenhagen, Christoph; Simon, Thorsten; Berthold, Frank; Hero, Barbara; Faldum, Andreas; Fischer, Matthias

2017-12-01

Current risk stratification systems for neuroblastoma patients consider clinical, histopathological, and genetic variables, and additional prognostic markers have been proposed in recent years. We here sought to select highly informative covariates in a multistep strategy based on consecutive Cox regression models, resulting in a risk score that integrates hazard ratios of prognostic variables. A cohort of 695 neuroblastoma patients was divided into a discovery set (n=75) for multigene predictor generation, a training set (n=411) for risk score development, and a validation set (n=209). Relevant prognostic variables were identified by stepwise multivariable L1-penalized least absolute shrinkage and selection operator (LASSO) Cox regression, followed by backward selection in multivariable Cox regression, and then integrated into a novel risk score. The variables stage, age, MYCN status, and two multigene predictors, NB-th24 and NB-th44, were selected as independent prognostic markers by LASSO Cox regression analysis. Following backward selection, only the multigene predictors were retained in the final model. Integration of these classifiers in a risk scoring system distinguished three patient subgroups that differed substantially in their outcome. The scoring system discriminated patients with diverging outcome in the validation cohort (5-year event-free survival, 84.9±3.4 vs 63.6±14.5 vs 31.0±5.4; P<.001), and its prognostic value was validated by multivariable analysis. We here propose a translational strategy for developing risk assessment systems based on hazard ratios of relevant prognostic variables. Our final neuroblastoma risk score comprised two multigene predictors only, supporting the notion that molecular properties of the tumor cells strongly impact clinical courses of neuroblastoma patients. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Clinical efficacy of crataegus extract WS 1442 in congestive heart failure NYHA class II.

PubMed

Zapfe jun, G

2001-07-01

In a randomised, placebo-controlled, double-blind clinical study the clinical efficacy and safety of Crataegus extract WS 1442, standardised to 18.75% oligomeric procyanidines, were investigated in 40 female and male outpatients suffering from congestive heart failure NYHA class II. Following a wash-out period of up to seven days, the patients were randomised to be treated for 12 weeks with either WS 1442 (3 x 1 capsule) or placebo. The primary outcome variable was exercise tolerance determined with bicycle exercise testing; as a secondary outcome variable the difference of the double product was calculated. On average, the exercise tolerance increased by 66.3 W x min (10.8%) in the WS 1442 group while in the placebo group a reduction of 105.3 W x min (16.9%) was measured. This difference between the groups was borderline statistically significant (p = 0.06). During the three month therapy the difference of the double product (heart rate x systolic blood pressure x 10(-2)) decreased by 14.4 mmHg s(-1) (26.8%) in the WS 1442 group and by 1.3 mmHg s(-1) (2.7%) in the placebo group, respectively. Recording of laboratory parameters and adverse events showed that WS 1442 was safe and well tolerated. The data show that Crataegus extract WS 1442 is clinically effective in patients with congestive heart failure corresponding to NYHA class II.

Clustering of metabolic and cardiovascular risk factors in the polycystic ovary syndrome: a principal component analysis.

PubMed

Stuckey, Bronwyn G A; Opie, Nicole; Cussons, Andrea J; Watts, Gerald F; Burke, Valerie

2014-08-01

Polycystic ovary syndrome (PCOS) is a prevalent condition with heterogeneity of clinical features and cardiovascular risk factors that implies multiple aetiological factors and possible outcomes. To reduce a set of correlated variables to a smaller number of uncorrelated and interpretable factors that may delineate subgroups within PCOS or suggest pathogenetic mechanisms. We used principal component analysis (PCA) to examine the endocrine and cardiometabolic variables associated with PCOS defined by the National Institutes of Health (NIH) criteria. Data were retrieved from the database of a single clinical endocrinologist. We included women with PCOS (N = 378) who were not taking the oral contraceptive pill or other sex hormones, lipid lowering medication, metformin or other medication that could influence the variables of interest. PCA was performed retaining those factors with eigenvalues of at least 1.0. Varimax rotation was used to produce interpretable factors. We identified three principal components. In component 1, the dominant variables were homeostatic model assessment (HOMA) index, body mass index (BMI), high density lipoprotein (HDL) cholesterol and sex hormone binding globulin (SHBG); in component 2, systolic blood pressure, low density lipoprotein (LDL) cholesterol and triglycerides; in component 3, total testosterone and LH/FSH ratio. These components explained 37%, 13% and 11% of the variance in the PCOS cohort respectively. Multiple correlated variables from patients with PCOS can be reduced to three uncorrelated components characterised by insulin resistance, dyslipidaemia/hypertension or hyperandrogenaemia. Clustering of risk factors is consistent with different pathogenetic pathways within PCOS and/or differing cardiometabolic outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials.

PubMed

de Ribamar Costa, José; Abizaid, Alexandre; Bartorelli, Antonio L; Whitbourn, Robert; Jepson, Nigel; Perin, Marco; Steinwender, Clemens; Stuteville, Marrianne; Ediebah, Divine; Sudhir, Krishnankutty; Serruys, Patrick W

2016-11-20

We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial. ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation. At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

Effect of Intensive Oral Hygiene Regimen During Pregnancy on Periodontal Health, Cytokine Levels, and Pregnancy Outcomes: A Pilot Study

PubMed Central

Kaur, Maninder; Geisinger, Maria L.; Geurs, Nicolaas C.; Griffin, Russell; Vassilopoulos, Philip J.; Vermeulen, Lisa; Haigh, Sandra; Reddy, Michael S.

2015-01-01

Background Data are limited on the potential effect of intensive oral hygiene regimens and periodontal therapy during pregnancy on periodontal health, gingival crevicular fluid (GCF) and serum cytokines, and pregnancy outcomes. Methods A clinical trial was conducted on 120 community-dwelling, 16- to 35-year-old pregnant women at 16 to 24 weeks of gestation. Each participant presented with clinical evidence of generalized, moderate-to-severe gingivitis. Oral hygiene products were provided, together with instructions for an intensive daily regimen of hygiene practices. Non-surgical therapy was provided at baseline. Oral examinations were completed at baseline and again at 4 and 8 weeks. In addition, samples of blood and GCF were collected at baseline and week 8. Mean changes in clinical variables and GCF and serum cytokine levels (interleukin [IL]-1β, IL-6, tumor necrosis factor [TNF]-α) between baseline and week 8 were calculated using paired t test. Pregnancy outcomes were recorded at parturition. Results Results indicated a statistically significant reduction in all clinical variables (P <0.0001) and decreased levels of TNF-α (P = 0.0076) and IL-1β (P = 0.0098) in GCF during the study period. The rate of preterm births (<37 weeks of gestation) was 6.7% (P = 0.113) and low birth weight (<2,500 g) was 10.2% (P = 1.00). Conclusions Among the population studied, intensive instructions and non-surgical periodontal therapy provided during 8 weeks at early pregnancy resulted in decreased gingival inflammation and a generalized improvement in periodontal health. Large-scale, randomized, controlled studies are needed to substantiate these findings. PMID:25079400

Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program.

PubMed

Lee, Michael S; Yang, Tae; Lasala, John; Cox, David

2016-11-15

The purpose of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with coronary artery calcification (CAC). Smaller studies have reported worse clinical outcomes in patients with CAC who undergo PCI. The impact of CAC in the drug-eluting stent era is unclear. Data from 7,492 patients treated by PCI with ≥1 TAXUS Express stent in the ARRIVE registry with no inclusion/exclusion criteria were stratified by the severity of CAC, as determined by the operator. Endpoints were independently adjudicated. All major adverse cardiac events were assessed at 2 years. Moderate/severe CAC was present in 19.6%. The nil/mild CAC group had higher rate of current smokers. The moderate/severe CAC group was older and had a higher prevalence of hypertension, kidney disease, prior coronary artery bypass grafting, congestive heart failure, and left main disease. After adjustment for imbalanced baseline variables, patients with moderate/severe CAC had higher 2 year rates of major adverse cardiac events (18.3% vs 13.5%, p = 0.01) and death (10.3% vs 5.6%, p = 0.02). Moderate/severe CAC was associated with increased clinical events in patients who underwent PCI with TAXUS stents. This may be explained in part due to differences important baseline characteristics including more patients with more comorbidities and more complex lesions. After adjustment for imbalanced baseline variables, the moderate/severe CAC group had a higher risk of major adverse cardiac events and death. Improvements in treatment strategies are needed for this high-risk group of patients who undergo PCI. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Use of active video gaming in children with neuromotor dysfunction: a systematic review.

PubMed

Hickman, Robbin; Popescu, Lisa; Manzanares, Robert; Morris, Brendan; Lee, Szu-Ping; Dufek, Janet S

2017-09-01

To examine current evidence on use of active video gaming (AVG) to improve motor function in children with movement disorders including cerebral palsy, developmental coordination disorder, and Down syndrome. Scopus, MEDLINE, Cochrane Library, EMBASE, and CINAHL were searched. Included papers studied the use of AVG for improving movement-related outcomes in these populations. Parameters studied included health condition, strength of evidence, AVG delivery methods, capacity for individualizing play, outcomes addressed, effectiveness for achieving outcomes, and challenges/limitations. The 20 extracted articles varied in quality. Studies involved children with six different conditions using AVG in clinical, home, or school settings for 49 different motor outcomes. Dosage varied in frequency and duration. Choice of games played and difficulty level were therapist determined (n=6) or child controlled (n=14). The most common study limitations were small sample sizes and difficulty individualizing treatment. All articles showed improvement in outcomes with AVG, although differences were not consistently significant compared with conventional therapy. Heterogeneity of measurement tools and target outcomes prevented meta-analysis or development of formal recommendations. However, AVG is feasible and shows potential for improving outcomes in this population. Additional investigations of dosing variables, utility as a home supplement to clinical care, and outcomes with larger sample sizes are merited. © 2017 Mac Keith Press.

Blood pressure (BP) assessment-from BP level to BP variability.

PubMed

Feber, Janusz; Litwin, Mieczyslaw

2016-07-01

The assessment of blood pressure (BP) can be challenging in children, especially in very young individuals, due to their variable body size and lack of cooperation. In the absence of data relating BP with cardiovascular outcomes in children, there is a need to convert absolute BP values (in mmHg) into age-, gender- and height appropriate BP percentiles or Z-scores in order to compare a patient's BP with the BP of healthy children of the same age, but also of children of different ages. Traditionally, the interpretation of BP has been based mainly on the assessment of the BP level obtained by office, home or 24-h BP monitoring. Recent studies suggest that it is not only BP level (i.e. average BP) but also BP variability that is clinically important for the development of target organ damage, including the progression of chronic kidney disease. In this review we describe current methods to evaluate of BP level, outline available methods for BP variability assessment and discuss the clinical consequences of BP variability, including its potential role in the management of hypertension.

Drug Concentration Thresholds Predictive of Therapy Failure and Death in Children With Tuberculosis: Bread Crumb Trails in Random Forests.

PubMed

Swaminathan, Soumya; Pasipanodya, Jotam G; Ramachandran, Geetha; Hemanth Kumar, A K; Srivastava, Shashikant; Deshpande, Devyani; Nuermberger, Eric; Gumbo, Tawanda

2016-11-01

 The role of drug concentrations in clinical outcomes in children with tuberculosis is unclear. Target concentrations for dose optimization are unknown.  Plasma drug concentrations measured in Indian children with tuberculosis were modeled using compartmental pharmacokinetic analyses. The children were followed until end of therapy to ascertain therapy failure or death. An ensemble of artificial intelligence algorithms, including random forests, was used to identify predictors of clinical outcome from among 30 clinical, laboratory, and pharmacokinetic variables.  Among the 143 children with known outcomes, there was high between-child variability of isoniazid, rifampin, and pyrazinamide concentrations: 110 (77%) completed therapy, 24 (17%) failed therapy, and 9 (6%) died. The main predictors of therapy failure or death were a pyrazinamide peak concentration <38.10 mg/L and rifampin peak concentration <3.01 mg/L. The relative risk of these poor outcomes below these peak concentration thresholds was 3.64 (95% confidence interval [CI], 2.28-5.83). Isoniazid had concentration-dependent antagonism with rifampin and pyrazinamide, with an adjusted odds ratio for therapy failure of 3.00 (95% CI, 2.08-4.33) in antagonism concentration range. In regard to death alone as an outcome, the same drug concentrations, plus z scores (indicators of malnutrition), and age <3 years, were highly ranked predictors. In children <3 years old, isoniazid 0- to 24-hour area under the concentration-time curve <11.95 mg/L × hour and/or rifampin peak <3.10 mg/L were the best predictors of therapy failure, with relative risk of 3.43 (95% CI, .99-11.82).  We have identified new antibiotic target concentrations, which are potential biomarkers associated with treatment failure and death in children with tuberculosis. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

Distal embolization during native vessel and vein graft coronary intervention with a vascular protection device: predictors of high-risk lesions.

PubMed

El-Jack, Seif S; Suwatchai, Pornratanarangsi; Stewart, James T; Ruygrok, Peter N; Ormiston, John A; West, Teena; Webster, Mark W I

2007-12-01

We sought to define clinical and angiographic variables that may predict patients and lesions at increased risk for distal embolism during percutaneous intervention (PCI), as assessed by debris retrieval from a distal-protection filter device. Distal thrombo- and atheroembolism may contribute to periprocedural myocardial necrosis during PCI, which may in turn affect long-term outcomes. Distal protection devices have been used to reduce this occurrence with variable outcomes depending on lesion and patient subsets. 194 consecutive patients in whom the FilterWire(R) device (FW) [Boston Scientific Corp., Natick, MA] was used for native coronary vessel (n =129) or vein graft (n = 65) PCI were studied. FW debris was visually analyzed using a semi-quantitative grading score. Patients with "significant" debris (particles > or = 1 mm diameter) were compared with those with "nonsignificant" debris (no debris or particles <1 mm) with respect to clinical (age, gender, coronary disease risk factors, clinical presentation, periprocedural medications), and angiographic (vessel treated, vessel size, lesion length, lesion characteristics, angiographic thrombus and TIMI flow before and after PCI) variables. Significant debris was retrieved in 55% of patients, more frequently from vein graft (69%) than native vessel lesions (48%, p = 0.006). No clinical characteristics predicted significant debris retrieval. Angiographic predictors of significant debris by multivariate analysis were longer stent length and final TIMI flow <3 (p = 0.009 and 0.007, respectively). Longer stent length, likely reflecting increased lesion length and plaque burden, predicted significant distal embolism during PCI in native vessel and vein graft lesions, as assessed by debris collected in a distal vascular protection device. This suggests that use of vascular protection devices should be considered during PCI of long lesions.

From vital signs to clinical outcomes for patients with sepsis: a machine learning basis for a clinical decision support system

PubMed Central

Gultepe, Eren; Green, Jeffrey P; Nguyen, Hien; Adams, Jason; Albertson, Timothy; Tagkopoulos, Ilias

2014-01-01

Objective To develop a decision support system to identify patients at high risk for hyperlactatemia based upon routinely measured vital signs and laboratory studies. Materials and methods Electronic health records of 741 adult patients at the University of California Davis Health System who met at least two systemic inflammatory response syndrome criteria were used to associate patients’ vital signs, white blood cell count (WBC), with sepsis occurrence and mortality. Generative and discriminative classification (naïve Bayes, support vector machines, Gaussian mixture models, hidden Markov models) were used to integrate heterogeneous patient data and form a predictive tool for the inference of lactate level and mortality risk. Results An accuracy of 0.99 and discriminability of 1.00 area under the receiver operating characteristic curve (AUC) for lactate level prediction was obtained when the vital signs and WBC measurements were analysed in a 24 h time bin. An accuracy of 0.73 and discriminability of 0.73 AUC for mortality prediction in patients with sepsis was achieved with only three features: median of lactate levels, mean arterial pressure, and median absolute deviation of the respiratory rate. Discussion This study introduces a new scheme for the prediction of lactate levels and mortality risk from patient vital signs and WBC. Accurate prediction of both these variables can drive the appropriate response by clinical staff and thus may have important implications for patient health and treatment outcome. Conclusions Effective predictions of lactate levels and mortality risk can be provided with a few clinical variables when the temporal aspect and variability of patient data are considered. PMID:23959843

In a stroke cohort with incident hypertension; are more women than men likely to be excluded from recombinant tissue-type Plasminogen Activator (rtPA)?

PubMed

Gainey, Jordan; Brechtel, Leanne; Konklin, Sarah; Madeline, Lee; Lowther, Ervin; Blum, Brice; Nathaniel, Thomas I

2018-04-15

The treatment outcomes in the use of rt-PA have been reported. Some studies reported worse outcome in women than men, while others presented opposing data. Using data from a hospital-based stroke registry, we investigated evidence of gender difference and determined exclusion criteria in a stroke population with incidence of hypertension. In a stroke population of women and men with incident of hypertension from a stroke registry, demographics and clinical factors were compared. Univariate analysis was used to determine gender differences, while multivariable models adjusted for demographic and clinical variables. Among the 669 stroke patients with incident of hypertension that were excluded from rt-PA treatment, 362 were female and 307 were male. Female patients with increasing age (OR = 0.956-0.984, P < 0.001), diabetes mellitus (OR = 0.095-0.559, P = 0.001), higher NIH stroke scale score (OR = 1.019-1.090, P = 0.002), previous stroke (OR = 0.337-0.850, P = 0.008), diabetes medication (OR = 1.200-7.724, P = 0.019), and INR (OR = 0.033-0.597, P = 0.008) are more likely to be excluded. Male patients with a history of a previous stroke (OR = 0.265-0.704, P = 0.001), risk of mortality (OR = 0.803-0.950, P = 0.002), higher NIH stroke scale score(OR = 1.101-1.276, P < 0.001), cholesterol reducing medication (OR = 1.191-2.910, P = 0.006), weakness at presentation(OR = 1.207-4.421, P = 0.011), and INR (OR = 0.016-0.243, P < 0.001) are more likely to be excluded. Women have a worse outcome than men in an untreated acute ischemic stroke population, but when treated, women have a better treatment outcome compared to men. In a hypertensive stroke population, the clinical variables for the exclusion criteria for women and men are significantly different, even after adjustment for confounding variables. Copyright © 2018 Elsevier B.V. All rights reserved.

Sex as a Biological Variable in Emergency Medicine Research and Clinical Practice: A Brief Narrative Review

PubMed Central

McGregor, Alyson J.; Beauchamp, Gillian A.; Wira, Charles R.; Perman, Sarah M.; Safdar, Basmah

2017-01-01

The National Institutes of Health recently highlighted the significant role of sex as a biological variable (SABV) in research design, outcome and reproducibility, mandating that this variable be accounted for in all its funded research studies. This move has resulted in a rapidly increasing body of literature on SABV with important implications for changing the clinical practice of emergency medicine (EM). Translation of this new knowledge to the bedside requires an understanding of how sex-based research will ultimately impact patient care. We use three case-based scenarios in acute myocardial infarction, acute ischemic stroke and important considerations in pharmacologic therapy administration to highlight available data on SABV in evidence-based research to provide the EM community with an important foundation for future integration of patient sex in the delivery of emergency care as gaps in research are filled. PMID:29085541

Improving health care, Part 1: The clinical value compass.

PubMed

Nelson, E C; Mohr, J J; Batalden, P B; Plume, S K

1996-04-01

CLINICAL VALUE COMPASS APPROACH: The clinical Value Compass, named to reflect its similarity in layout to a directional compass, has at its four cardinal points (1) functional status, risk status, and well-being; (2) costs; (3) satisfaction with health care and perceived benefit; and (4) clinical outcomes. To manage and improve the value of health care services, providers will need to measure the value of care for similar patient populations, analyze the internal delivery processes, run tests of changed delivery processes, and determine if these changes lead to better outcomes and lower costs. GETTING STARTED--OUTCOMES AND AIM: In the case example, the team's aim is "to find ways to continually improve the quality and value of care for AMI (acute myocardial infection) patients." VALUE MEASURES--SELECT A SET OF OUTCOME AND COST MEASURES: Four to 12 outcome and cost measures are sufficient to get started. In the case example, the team chose 1 or more measures for each quadrant of the value compass. An operational definition is a clearly specified method explaining how to measure a variable. Measures in the case example were based on information from the medical record, administrative and financial records, and patient reports and ratings at eight weeks postdischarge. Measurement systems that quantify the quality of processes and results of care are often add-ons to routine care delivery. However, the process of measurement should be intertwined with the process of care delivery so that front-line providers are involved in both managing the patient and measuring the process and related outcomes and costs.

The predictor of mortality outcome in adult patients with Ebola virus disease during the 2014-2015 outbreak in Guinea.

PubMed

Cherif, M S; Koonrungsesomboon, N; Diallo, M P; Le Gall, E; Kassé, D; Cherif, F; Koné, A; Diakité, M; Camara, F; Magassouba, N

2017-04-01

The purpose of this study was to examine the association of any demographic and clinical factors with mortality outcome among adult patients with Ebola virus disease (EVD) in Guinea. This retrospective observational study analyzed medical records of laboratory confirmed EVD adult patients during the 2014-2015 EVD outbreak in Guinea. The associations between any demographic or clinical variables and mortality outcome of EVD were assessed using univariate and multivariate logistic regression analyses. Of 2,310 EVD adult patients included for analysis, the overall case fatality rate was 68.1%. Univariate analyses identified factors possibly associated with mortality outcome, including patient age (p < 0.001), history of visiting or close contact with a suspected or confirmed EVD patient (p = 0.035), and seven clinical symptoms on admission, i.e., fever (p = 0.003), hiccups (p < 0.001), vomiting (p = 0.003), diarrhea (p < 0.001), cough (p = 0.001), sore throat (p = 0.016), and unexplained bleeding (p = 0.021). The multivariate analysis showed that patient age was independently associated with mortality outcome of EVD (OR = 1.06; 95%CI = 1.03-1.09; p < 0.001), while none the of clinical symptoms on admission were significantly associated with the mortality outcome. Our analysis indicates that older age was the only independent factor associated with death among EVD adult patients in Guinea. This suggests that older EVD patients should receive intensive medical care and be carefully monitored.

Outcome Trajectories in Extremely Preterm Infants

PubMed Central

Carlo, Waldemar A.; Tyson, Jon E.; Langer, John C.; Walsh, Michele C.; Parikh, Nehal A.; Das, Abhik; Van Meurs, Krisa P.; Shankaran, Seetha; Stoll, Barbara J.; Higgins, Rosemary D.

2012-01-01

OBJECTIVE: Methods are required to predict prognosis with changes in clinical course. Death or neurodevelopmental impairment in extremely premature neonates can be predicted at birth/admission to the ICU by considering gender, antenatal steroids, multiple birth, birth weight, and gestational age. Predictions may be improved by using additional information available later during the clinical course. Our objective was to develop serial predictions of outcome by using prognostic factors available over the course of NICU hospitalization. METHODS: Data on infants with birth weight ≤1.0 kg admitted to 18 large academic tertiary NICUs during 1998–2005 were used to develop multivariable regression models following stepwise variable selection. Models were developed by using all survivors at specific times during hospitalization (in delivery room [n = 8713], 7-day [n = 6996], 28-day [n = 6241], and 36-week postmenstrual age [n = 5118]) to predict death or death/neurodevelopmental impairment at 18 to 22 months. RESULTS: Prediction of death or neurodevelopmental impairment in extremely premature infants is improved by using information available later during the clinical course. The importance of birth weight declines, whereas the importance of respiratory illness severity increases with advancing postnatal age. The c-statistic in validation models ranged from 0.74 to 0.80 with misclassification rates ranging from 0.28 to 0.30. CONCLUSIONS: Dynamic models of the changing probability of individual outcome can improve outcome predictions in preterm infants. Various current and future scenarios can be modeled by input of different clinical possibilities to develop individual “outcome trajectories” and evaluate impact of possible morbidities on outcome. PMID:22689874

Subventricular zone predicts high velocity of tumor expansion and poor clinical outcome in patients with low grade astrocytoma.

PubMed

Wen, Bing; Fu, Feixian; Hu, Liangbo; Cai, Qiuyi; Xie, Junshi

2018-05-01

The aim of this study is to clarify the association between subventricular zone (SVZ) involvement and velocity of diametric expansion(VDE) in patients with low-grade astrocytoma and also assessed the clinical outcome of those patients. A total of 168 adult patients with newly diagnosed supratentorial low-grade astrocytoma were studied retrospectively. There were 73 patients had SVZ involvement. Patients with SVZ involvement(7.16 ± 6.53 mm/y) had a higher VDE than patients without SVZ involvement(4.38 ± 5.35 mm/y). VDE was modeled as a categorical variable(＜4, ≥4 and, ＜8, ≥8 and, ＜12, ≥12 mm/y). Logistic regression showed that SVZ involvement was associated with high VDE after adjusting by confounding variables. On the univariate analysis, the results showed that tumor involved with SVZ, VDE ≥ 4 mm/y, VDE ≥ 8 mm/y, and VDE ≥ 8 mm/y were significant predictors of a shorter OS, progression-free survival (PFS) and malignant progression-free survival (MFS)(all p ＜0.05). The categorical variables of VDE (＜4 mm/y, ≥4 mm/y and, ＜8 mm/y, ≥8 mm/y and, ＜12 mm/y, ≥12 mm/y) were adjusted by confounding variables in multivariate analysis, respectively. The results indicated that VDE ≥ 8 mm/y, VDE ≥ 12 mm/y were worse prognostic factors for OS, while VDE ≥ 4 mm/y, VDE ≥ 8 mm/y and VDE ≥ 12 mm/y were related to shorter PFS and MFS. In addition, SVZ involvement was prognostic factors in predicting OS and PFS except MFS. Our results demonstrated that SVZ involvement predicted high VDE and worse clinical outcome, and high VDE was associated with poor prognosis in patients with low-grade astrocytoma. Copyright © 2018 Elsevier B.V. All rights reserved.

Central sensitization does not identify patients with carpal tunnel syndrome who are likely to achieve short-term success with physical therapy.

PubMed

Fernández-de-Las-Peñas, César; Cleland, Joshua A; Ortega-Santiago, Ricardo; de-la-Llave-Rincon, Ana Isabel; Martínez-Perez, Almudena; Pareja, Juan A

2010-11-01

The aim of the current study was to identify whether hyperexcitability of the central nervous system is a prognostic factor for individuals with carpal tunnel syndrome (CTS) likely to experience rapid and clinical self-reported improvement following a physical therapy program including soft tissue mobilization and nerve slider neurodynamic interventions. Women presenting with clinical and electrophysiological findings of CTS were involved in a prospective single-arm trial. Participants underwent a standardized examination and then a physical therapy session. The physical therapy sessions included both soft tissue mobilization directed at the anatomical sites of potential median nerve entrapment and a passive nerve slider neurodynamic technique targeted to the median nerve. Pressure pain thresholds (PPT) over the median, radial and ulnar nerves, C5-C6 zygapophyseal joint, carpal tunnel and tibialis anterior muscle were assessed bilaterally. Additionally, thermal detection and pain thresholds were measured over the carpal tunnel and thenar eminence bilaterally to evaluate central nervous system excitability. Subjects were classified as responders (having achieved a successful outcome) or non-responders based on self-perceived recovery. Variables were entered into a stepwise logistic regression model to determine the most accurate variables for determining prognosis. Data from 72 women were included in the analysis, of which 35 experienced a successful outcome (48.6%). Three variables including PPT over the C5-C6 joint affected side <137 kPa, HPT carpal tunnel affected side <39.6º and general health >66 points were identified. If 2 out of 3 variables were present (LR + 14.8), the likelihood of success increased from 48.6 to 93.3%. We identified 3 factors that may be associated with a rapid clinical response to both soft tissue mobilization and nerve slider neurodynamic techniques targeted to the median nerve in women presenting with CTS. Our results support that widespread central sensitization may not be present in women with CTS who are likely to achieve a successful outcome with physical therapy. Future studies are now necessary to validate these findings.

Gender roles in persistent sex differences in health-related quality-of-life outcomes of patients with coronary artery disease.

PubMed

Norris, Colleen M; Murray, Joshua W; Triplett, Leona S; Hegadoren, Kathleen M

2010-08-01

The increased recognition of significant sex/gender differences in health status outcomes, and the implications for clinical practice and service delivery, has led to calls for more gender sensitivity and specificity in research endeavors as well as within clinical practice. Previous investigations by our research group have consistently identified important sex differences in both changes in health status from baseline to 1 year and in health status outcomes of patients treated for coronary artery disease (CAD), with women reporting poorer health-related quality of life (HRQoL) compared with men. The objective of this study was to examine whether persistent sex differences in the health status of patients with CAD may be attributed to social factors such as gender roles. Sex differences in baseline clinical and demographic characteristics of patients who completed the 1-year follow-up survey were examined using t tests and χ(2) analyses. Structural equation modeling, an inclusive statistical modeling approach for testing hypotheses about relationships among measured and latent variables (concepts not observed or measured directly), was used to test our theoretical model. HRQoL data were collected on 2403 patients 1 year after index catheterization. The results indicated that the model fit was substantially improved by the addition of the conceptualized gender-role variable. Furthermore, there was a significant effect of gender role on QoL (-0.106; P < 0.05). Age, coronary anatomy, ejection fraction, physical limitation, anginal frequency, and gender role variables in this model were able to explain 51% of the variance in HRQoL. In particular, reported physical limitations, anginal frequency, and gender role had large statistically significant direct effects on HRQoL. Advances in the treatment of CAD have led to significant decreases in mortality rates. Our current challenge is to minimize the long-term impact of CAD on HRQoL outcomes. While a substantial body of literature has examined the correlations between gender-role attributes and a wide variety of both positive and negative outcomes, this area has not been explored in patients with cardiovascular disease. These findings suggest that further study of the influence of gender role (using a gender-role measurement) on HRQoL is needed. Copyright © 2010 Excerpta Medica Inc. All rights reserved.

The impact of self-efficacy, expectations, and readiness on hearing aid outcomes.

PubMed

Ferguson, Melanie A; Woolley, Annie; Munro, Kevin J

2016-07-01

To examine the impact of self-efficacy and expectations for hearing aids, and readiness to improve hearing, on hearing aid outcome measures in first-time adult hearing aid users Design: A prospective, single centre design. Predictor variables measured at the hearing assessment included measures of self-efficacy, expectations and readiness to improve hearing. Outcome measures obtained at six-week follow-up were the Glasgow Hearing Aid Benefit Profile and Satisfaction with Amplification in Daily Life. A sample of 30 first-time adult hearing aid users were recruited through a public-sector funded audiology clinic. When measured prior to hearing aid fitting, self-efficacy for hearing aids predicted satisfaction with hearing aids but was not related to other hearing aid outcomes. Expectations of hearing aids, in particular positive expectations, and readiness to improve hearing predicted outcomes for hearing aid satisfaction and benefit, although not hearing aid use. Hearing sensitivity was not correlated with hearing aid outcomes. These results suggest that assessment of expectations of hearing aids, and readiness to improve hearing, may be useful to help identify individuals attending audiology clinics who would most likely benefit from hearing aid provision.

Thyroid dysfunctions of prematurity and their impacts on neurodevelopmental outcome.

PubMed

Chung, Mi Lim; Yoo, Han Wok; Kim, Ki-Soo; Lee, Byong Sop; Pi, Soo-Young; Lim, Gina; Kim, Ellen Ai-Rhan

2013-01-01

Thyroid dysfunction is very common and is associated with neurodevelopmental impairments in preterm infants. This study was conducted to determine the incidence and natural course of various thyroid dysfunctions and their impacts on neurodevelopmental outcomes among premature infants. A total of 177 infants were enrolled who were born at <34 weeks or whose birth weight was <1500 g and who underwent repeat thyroid function tests. We analyzed how various thyroid dysfunctions affected neurodevelopmental outcomes at 18 months of corrected age. Thyroid dysfunction was noted in 88 infants. Hypothyroxinemia was observed in 23 infants, and their thyroid function was influenced by variable clinical factors. Free T4 levels were all normalized without thyroxine medication, and neurodevelopmental outcomes were not affected. In contrast, hyperthyrotropinemia was not associated with other clinical factors. Among 58 subjects who had hyperthyrotropinemia, only 31 infants showed normal thyroid-stimulating hormone (TSH) levels at follow-up tests. The remaining 27 infants had persistently high TSH levels, which significantly and poorly influenced the neurodevelopmental outcomes. Thyroid dysfunction is common among preterm infants. With the exception of persistent hyperthyrotropinemia, it generally does not affect neurodevelopmental outcomes. However, the beneficial effects of thyroid hormone therapy in patients with persistent hyperthyrotropinemia merits further study.

Factors Predicting a Good Symptomatic Outcome After Prostate Artery Embolisation (PAE).

PubMed

Maclean, D; Harris, M; Drake, T; Maher, B; Modi, S; Dyer, J; Somani, B; Hacking, N; Bryant, T

2018-02-26

As prostate artery embolisation (PAE) becomes an established treatment for benign prostatic obstruction, factors predicting good symptomatic outcome remain unclear. Pre-embolisation prostate size as a predictor is controversial with a handful of papers coming to conflicting conclusions. We aimed to investigate if an association existed in our patient cohort between prostate size and clinical benefit, in addition to evaluating percentage volume reduction as a predictor of symptomatic outcome following PAE. Prospective follow-up of 86 PAE patients at a single institution between June 2012 and January 2016 was conducted (mean age 64.9 years, range 54-80 years). Multiple linear regression analysis was performed to assess strength of association between clinical improvement (change in IPSS) and other variables, of any statistical correlation, through Pearson's bivariate analysis. No major procedural complications were identified and clinical success was achieved in 72.1% (n = 62) at 12 months. Initial prostate size and percentage reduction were found to have a significant association with clinical improvement. Multiple linear regression analysis (r 2  = 0.48) demonstrated that percentage volume reduction at 3 months (r = 0.68, p < 0.001) had the strongest correlation with good symptomatic improvement at 12 months after adjusting for confounding factors. Both the initial prostate size and percentage volume reduction at 3 months predict good symptomatic outcome at 12 months. These findings therefore aid patient selection and counselling to achieve optimal outcomes for men undergoing prostate artery embolisation.

Spoken language outcomes after hemispherectomy: factoring in etiology.

PubMed

Curtiss, S; de Bode, S; Mathern, G W

2001-12-01

We analyzed postsurgery linguistic outcomes of 43 hemispherectomy patients operated on at UCLA. We rated spoken language (Spoken Language Rank, SLR) on a scale from 0 (no language) to 6 (mature grammar) and examined the effects of side of resection/damage, age at surgery/seizure onset, seizure control postsurgery, and etiology on language development. Etiology was defined as developmental (cortical dysplasia and prenatal stroke) and acquired pathology (Rasmussen's encephalitis and postnatal stroke). We found that clinical variables were predictive of language outcomes only when they were considered within distinct etiology groups. Specifically, children with developmental etiologies had lower SLRs than those with acquired pathologies (p =.0006); age factors correlated positively with higher SLRs only for children with acquired etiologies (p =.0006); right-sided resections led to higher SLRs only for the acquired group (p =.0008); and postsurgery seizure control correlated positively with SLR only for those with developmental etiologies (p =.0047). We argue that the variables considered are not independent predictors of spoken language outcome posthemispherectomy but should be viewed instead as characteristics of etiology. Copyright 2001 Elsevier Science.

Configuration and validation of a novel prostate disease nomogram predicting prostate biopsy outcome: A prospective study correlating clinical indicators among Filipino adult males with elevated PSA level.

PubMed

Chua, Michael E; Tanseco, Patrick P; Mendoza, Jonathan S; Castillo, Josefino C; Morales, Marcelino L; Luna, Saturnino L

2015-04-01

To configure and validate a novel prostate disease nomogram providing prostate biopsy outcome probabilities from a prospective study correlating clinical indicators and diagnostic parameters among Filipino adult male with elevated serum total prostate specific antigen (PSA) level. All men with an elevated serum total PSA underwent initial prostate biopsy at our institution from January 2011 to August 2014 were included. Clinical indicators, diagnostic parameters, which include PSA level and PSA-derivatives, were collected as predictive factors for biopsy outcome. Multiple logistic-regression analysis involving a backward elimination selection procedure was used to select independent predictors. A nomogram was developed to calculate the probability of the biopsy outcomes. External validation of the nomogram was performed using separate data set from another center for determination of sensitivity and specificity. A receiver-operating characteristic (ROC) curve was used to assess the accuracy in predicting differential biopsy outcome. Total of 552 patients was included. One hundred and ninety-one (34.6%) patients had benign prostatic hyperplasia, and 165 (29.9%) had chronic prostatitis. The remaining 196 (35.5%) patients had prostate adenocarcinoma. The significant independent variables used to predict biopsy outcome were age, family history of prostate cancer, prior antibiotic intake, PSA level, PSA-density, PSA-velocity, echogenic findings on ultrasound, and DRE status. The areas under the receiver-operating characteristic curve for prostate cancer using PSA alone and the nomogram were 0.688 and 0.804, respectively. The nomogram configured based on routinely available clinical parameters, provides high predictive accuracy with good performance characteristics in predicting the prostate biopsy outcome such as presence of prostate cancer, high Gleason prostate cancer, benign prostatic hyperplasia, and chronic prostatitis.

Clinical and functional outcomes of patients who experience partial response to citalopram: secondary analysis of STAR*D.

PubMed

Dennehy, Ellen B; Marangell, Lauren B; Martinez, James; Balasubramani, G K; Wisniewski, Stephen R

2014-05-01

We analyzed the public STAR*D database to better characterize the baseline clinical characteristics and functional outcomes of patients with major depressive disorder (MDD) who experienced partial response in order to better understand the burden associated with this outcome. Patients (n=2,876) received treatment with citalopram. The last available Quick Inventory of Depressive Symptoms (QIDS-SR) from the 12-week treatment period was used to assign subjects to one of three groups: remitters QIDS-SR≤5; non-responders QIDS-SR >5 and <25% reduction from baseline; and partial responders QIDS-SR >5 and ≥25% reduction from baseline. Baseline sociodemographic and clinical characteristics were compared across groups, as well as functional outcomes at Level 1 exit. RESULTS. Of the 2,876 patients, 943 patients (33%) were classified as remitters, 1069 (37%) as partial responders, and 854 (30%) as non-responders. The groups differed on a number of pre-treatment course of illness variables and comorbidities. In addition, remitters, partial responders, and non-responders all separated on posttreatment quality of life and functional outcomes at Level 1 exit. Partial responders demonstrated significant functional impairment at Level 1 exit, differing significantly from the patients who remitted on quality of life, mental and physical functioning, and social and work-related impairment. Adjusted outcomes showed similar differences. Differences in baseline rates of suicidality, comorbidity, and atypical presentations of depression were also observed between outcome groups. Given the substantial clinical and economic burden associated with functional impairment in depression, the need to fully treat partially responding patients to achieve depression remission and restoration of functioning is highlighted by this work.

Association between helplessness, disability, and disease activity with health-related quality of life among rheumatoid arthritis patients in a multiethnic Asian population.

PubMed

Kwan, Yu Heng; Koh, Ee Tzun; Leong, Khai Pang; Wee, Hwee-Lin

2014-08-01

To investigate the association between helplessness, disability, and disease activity with health-related quality of life (HRQoL) in a multiethnic cohort of rheumatoid arthritis (RA) patients in Singapore. This cross-sectional study was conducted at Tan Tock Seng Hospital, Department of Rheumatology, Allergy and Immunology, from October 2010 to October 2011. All patients fulfilled the American College of Rheumatology 1987 criteria for RA. Socio-demographics, clinical, and patient-reported outcome (PRO) variables were collected. HRQoL outcomes were Short Form 36 (SF-36) physical and mental component summary (PCS and MCS) scores and Short Form 6 Dimensions (SF-6D) utilities. Stepwise multiple linear regression analyses were performed using HRQoL outcomes as dependent variables in separate models and with adjustment for helplessness (Rheumatology Attitudes Index, RAI), disability (Health Assessment Questionnaire, HAQ), and disease activity (Disease Activity in 28 joints) followed by socio-demographic, clinical, and PRO variables. Complete data were provided by 473 consenting subjects [mean (SD) age: 60.02 (11.04) years, 85 % female, 77 % Chinese]. After adjustment for all measured covariates, only RAI and HAQ scores remained significantly associated with SF-36 MCS (β: -0.9, p < 0.001; β: -7.0, p < 0.001) and SF-6D utilities (β: -0.005, p < 0.001; β: -0.081, p < 0.001), respectively, while only HAQ scores were significantly associated with SF-36 PCS (β: -7.7, p < 0.001). Interventions to address the sense of helplessness and to prevent or reduce disability could improve HRQoL of RA patients.

Factors affecting outcome in ocular myasthenia gravis.

PubMed

Mazzoli, Marco; Ariatti, Alessandra; Valzania, Franco; Kaleci, Shaniko; Tondelli, Manuela; Nichelli, Paolo F; Galassi, Giuliana

2018-01-01

50%-60% of patients with ocular myasthenia gravis (OMG) progress to generalized myasthenia gravis (GMG) within two years. The aim of our study was to explore factors affecting prognosis of OMG and to test the predictive role of several independent clinical variables. We reviewed a cohort of 168 Caucasian patients followed from September 2000 to January 2016. Several independent variables were considered as prognostic factors: gender, age of onset, results on electrophysiological tests, presence and level of antibodies against acetylcholine receptors (AChR Abs), treatments, thymic abnormalities. The primary outcome was the progression to GMG and/or the presence of bulbar symptoms. Secondary outcomes were either achievement of sustained minimal manifestation status or worsening in ocular quantitative MG subscore (O-QMGS) or worsening in total QMG score (T-QMGS), assessed by Myasthenia Gravis Foundation of America (MGFA) quantitative scores. Changes in mental and physical subscores of health-related quality of life (HRQoL) were assessed with SF-36 questionnaire. Variance analysis was used to interpret the differences between AChR Ab titers at different times of follow up among the generalized and non-generalized patients. Conversion to GMG occurred in 18.4% of patients; it was significantly associated with sex, later onset of disease and anti-AChR Ab positivity. Antibody titer above the mean value of 25.8 pmol/mL showed no significant effect on generalization. Sex and late onset of disease significantly affected T-QMGS worsening. None of the other independent variables significantly affected O-QMGS and HRQoL. Sex, later onset and anti-AChR Ab positivity were significantly associated with clinical worsening.

Asymptomatic Alzheimer disease: Defining resilience.

PubMed

Hohman, Timothy J; McLaren, Donald G; Mormino, Elizabeth C; Gifford, Katherine A; Libon, David J; Jefferson, Angela L

2016-12-06

To define robust resilience metrics by leveraging CSF biomarkers of Alzheimer disease (AD) pathology within a latent variable framework and to demonstrate the ability of such metrics to predict slower rates of cognitive decline and protection against diagnostic conversion. Participants with normal cognition (n = 297) and mild cognitive impairment (n = 432) were drawn from the Alzheimer's Disease Neuroimaging Initiative. Resilience metrics were defined at baseline by examining the residuals when regressing brain aging outcomes (hippocampal volume and cognition) on CSF biomarkers. A positive residual reflected better outcomes than expected for a given level of pathology (high resilience). Residuals were integrated into a latent variable model of resilience and validated by testing their ability to independently predict diagnostic conversion, cognitive decline, and the rate of ventricular dilation. Latent variables of resilience predicted a decreased risk of conversion (hazard ratio < 0.54, p < 0.0001), slower cognitive decline (β > 0.02, p < 0.001), and slower rates of ventricular dilation (β < -4.7, p < 2 × 10 -15 ). These results were significant even when analyses were restricted to clinically normal individuals. Furthermore, resilience metrics interacted with biomarker status such that biomarker-positive individuals with low resilience showed the greatest risk of subsequent decline. Robust phenotypes of resilience calculated by leveraging AD biomarkers and baseline brain aging outcomes provide insight into which individuals are at greatest risk of short-term decline. Such comprehensive definitions of resilience are needed to further our understanding of the mechanisms that protect individuals from the clinical manifestation of AD dementia, especially among biomarker-positive individuals. © 2016 American Academy of Neurology.

Addressing phenoconversion: the Achilles' heel of personalized medicine

PubMed Central

Shah, Rashmi R; Smith, Robert L

2015-01-01

Phenoconversion is a phenomenon that converts genotypic extensive metabolizers (EMs) into phenotypic poor metabolizers (PMs) of drugs, thereby modifying their clinical response to that of genotypic PMs. Phenoconversion, usually resulting from nongenetic extrinsic factors, has a significant impact on the analysis and interpretation of genotype-focused clinical outcome association studies and personalizing therapy in routine clinical practice. The high phenotypic variability or genotype–phenotype mismatch, frequently observed due to phenoconversion within the genotypic EM population, means that the real number of phenotypic PM subjects may be greater than predicted from their genotype alone, because many genotypic EMs would be phenotypically PMs. If the phenoconverted population with genotype–phenotype mismatch, most extensively studied for CYP2D6, is as large as the evidence suggests, there is a real risk that genotype-focused association studies, typically correlating only the genotype with clinical outcomes, may miss clinically strong pharmacogenetic associations, thus compromising any potential for advancing the prospects of personalized medicine. This review focuses primarily on co-medication-induced phenoconversion and discusses potential approaches to rectify some of the current shortcomings. It advocates routine phenotyping of subjects in genotype-focused association studies and proposes a new nomenclature to categorize study populations. Even with strong and reliable data associating patients' genotypes with clinical outcome(s), there are problems clinically in applying this knowledge into routine pharmacotherapy because of potential genotype–phenotype mismatch. Drug-induced phenoconversion during routine clinical practice remains a major public health issue. Therefore, the principal challenges facing personalized medicine, which need to be addressed, include identification of the following factors: (i) drugs that are susceptible to phenoconversion; (ii) co-medications that can cause phenoconversion; and (iii) dosage amendments that need to be applied during and following phenoconversion. PMID:24913012

The use of ketamine in ECT anaesthesia: A systematic review and critical commentary on efficacy, cognitive, safety and seizure outcomes.

PubMed

Gálvez, Verònica; McGuirk, Lucy; Loo, Colleen K

2017-09-01

This review will discuss ECT efficacy and cognitive outcomes when using ketamine as an ECT anaesthetic compared to other anaesthetics, taking into account important moderator variables that have often not been considered to date. It will also include information on safety and other ECT outcomes (seizure threshold and quality). A systematic search through MEDLINE, PubMed, PsychINFO, Cochrane Databases and reference lists from retrieved articles was performed. Search terms were: "ketamine" and "Electroconvulsive Therapy", from 1995 to September 2016. Meta-analyses, randomised controlled trials, open-label and retrospective studies published in English of depressed samples receiving ECT with ketamine anaesthesia were included (n = 24). Studies were heterogeneous in the clinical populations included and ECT treatment and anaesthetic methods. Frequently, studies did not report on ECT factors (i.e., pulse-width, treatment schedule). Findings regarding efficacy were mixed. Tolerance from repeated use may explain why several studies found that ketamine enhanced efficacy early in the ECT course but not at the end. The majority of studies did not comprehensively examine cognition and adverse effects were not systematically studied. Only a minority of the studies reported on seizure threshold and expression. The routine use of ketamine anaesthesia for ECT in clinical settings cannot yet be recommended based on published data. Larger randomised controlled trials, taking into account moderator variables, specifically reporting on ECT parameters and systematically assessing outcomes are encouraged.

Impact of urinary incontinence on medical rehabilitation inpatients.

PubMed

Mallinson, Trudy; Fitzgerald, Colleen M; Neville, Cynthia E; Almagor, Orit; Manheim, Larry; Deutsch, Anne; Heinemann, Allen

2017-01-01

To determine the prevalence of urinary incontinence (UI) and its association with rehabilitation outcomes in patients receiving inpatient medical rehabilitation in the United States. A retrospective, cohort study of 425,547 Medicare patients discharged from inpatient rehabilitation facilities (IRFs) in 2005. We examined prevalence of UI at admission and discharge for 5 impairment groups. We examined the impact of demographics, health, and functional status on the primary outcome, change in continence status, and secondary outcomes of discharge location and 6-month mortality. Approximately one-quarter (26.6%) of men were incontinent at admission compared to 22.2% of women. In all diagnostic groups, continence status remains largely unchanged from admission to discharge. Patients who are older, have cognitive difficulties, less functional improvement, and longer lengths of stay (LOS), are more likely to remain incontinent, compared to those who improved, after controlling for patient factors and clinical variables. UI was significantly associated with discharge to another post-acute setting (PAC). For orthopedic patients, UI was associated with a 71% increase in the likelihood of discharge to an institutional setting after controlling for patient factors and clinical variables. UI was not associated with death at 6 months post-discharge. UI is highly prevalent in IRF patients and is associated with increased likelihood of discharge to institutional care, particularly for orthopedic patients. Greater attention to identifying and treating UI in IRF patients may reduce medical expenditures and improve other outcomes. Neurourol. Urodynam. 36:176-183, 2017. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Risk stratification of prostate cancer: integrating multiparametric MRI, nomograms and biomarkers

PubMed Central

Watson, Matthew J; George, Arvin K; Maruf, Mahir; Frye, Thomas P; Muthigi, Akhil; Kongnyuy, Michael; Valayil, Subin G; Pinto, Peter A

2016-01-01

Accurate risk stratification of prostate cancer is achieved with a number of existing tools to ensure the identification of at-risk patients, characterization of disease aggressiveness, prediction of cancer burden and extrapolation of treatment outcomes for appropriate management of the disease. Statistical tables and nomograms using classic clinicopathological variables have long been the standard of care. However, the introduction of multiparametric MRI, along with fusion-guided targeted prostate biopsy and novel biomarkers, are being assimilated into clinical practice. The majority of studies to date present the outcomes of each in isolation. The current review offers a critical and objective assessment regarding the integration of multiparametric MRI and fusion-guided prostate biopsy with novel biomarkers and predictive nomograms in contemporary clinical practice. PMID:27400645

Advances in understanding Giardia: determinants and mechanisms of chronic sequelae

PubMed Central

Sartor, R. Balfour

2015-01-01

Giardia lamblia is a flagellated protozoan that is the most common cause of intestinal parasitic infection in children living in resource-limited settings. The pathogenicity of Giardia has been debated since the parasite was first identified, and clinical outcomes vary across studies. Among recent perplexing findings are diametrically opposed associations between Giardia and acute versus persistent diarrhea and a poorly understood potential for long-term sequelae, including impaired child growth and cognitive development. The mechanisms driving these protean clinical outcomes remain elusive, but recent advances suggest that variability in Giardia strains, host nutritional status, the composition of microbiota, co-infecting enteropathogens, host genetically determined mucosal immune responses, and immune modulation by Giardia are all relevant factors influencing disease manifestations after Giardia infection. PMID:26097735

Early Language Development in Blind and Severely Visually Impaired Children. Interim Report on Pilot Study.

ERIC Educational Resources Information Center

Moore, Vanessa; McConachie, Helen

This study investigated variables that might be associated with outcome differences in language development of 10 children (ages 10-20 months) with blindness or severe visual impairments, attending a developmental vision clinic in southern England. Subjects' early patterns of expressive language development were examined and related to observed…

Pursuit of Muscularity in Adolescent Boys: Relations among Biopsychosocial Variables and Clinical Outcomes

ERIC Educational Resources Information Center

Cafri, Guy; van den Berg, Patricia; Thompson, J. Kevin

2006-01-01

Adolescent boys (n = 269) were assessed for levels of several risky behaviors related to the pursuit of muscularity, including substance use (anabolic steroids, prohormones, and ephedrine) dieting to gain weight, and symptoms of muscle dysmorphia (MD). The association between these behaviors and a variety of putative biological, psychological, and…

Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review.

PubMed

Cairo, Francesco; Nieri, Michele; Pagliaro, Umberto

2014-04-01

The aim of this Systematic Review (SR) was to assess the clinical efficacy of periodontal plastic surgery procedures in the treatment of localized gingival recessions (Rec) with or without inter-dental clinical attachment loss (iCAL). Electronic and hand searches were performed to identify randomized clinical trials (RCTs) on treatment of single gingival recessions with at least 6 months of follow-up. Primary outcome variable was complete root coverage (CRC). Secondary outcome variables were recession reduction (RecRed) and keratinized tissue (KT) gain. To evaluate treatment effect, Odds Ratios were combined for dichotomous data and mean differences in continuous data using a random-effect model. Fifty-one RCTs (53 articles) with a total of 1574 treated patients (1744 recessions) were included in this SR. Finally, 30 groups of comparisons were identified and a total of 80 meta-analyses were performed. Coronally Advanced Flap (CAF) was associated with higher probability of CRC and higher amount of RecRed than Semilunar Coronal Positioned Flap (SCPF). The combination CAF plus Connective Tissue Graft (CAF+CTG) or CAF plus Enamel Matrix Derivative (CAF+EMD) was more effective than CAF alone in terms of CRC and RecRed. The combination CAF plus Collagen Matrix (CAF+CM) achieved higher RecRed than CAF alone. In addition, CAF+CTG achieved CRC more frequently than CAF+EMD, SCPF, Free Gingival Graft (FGG) and Laterally Positioned Flap (LPS). CAF+CTG was also associated with higher RecRed than Barrier Membranes (CAF+GTR), CAF+EMD and CAF+CM. GTR was not able to improve the clinical efficacy of CAF. Studies adding Acellular Dermal Matrix (ADM) under CAF showed a large heterogeneity and not significant benefits compared with CAF alone. Multiple combinations, using more than a single graft/biomaterial under the flap, usually provide similar or less benefits than simpler, control procedures in term of root coverage outcomes. CAF procedures alone or with CTG, EMD are supported by large evidence in modern periodontal plastic surgery. CAF+CTG achieved the best clinical outcomes in single gingival recessions with or without iCAL. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

CLINICAL APPLICATIONS OF CRYOTHERAPY AMONG SPORTS PHYSICAL THERAPISTS.

PubMed

Hawkins, Shawn W; Hawkins, Jeremy R

2016-02-01

Therapeutic modalities (TM) are used by sports physical therapists (SPT) but how they are used is unknown. To identify the current clinical use patterns for cryotherapy among SPT. Cross-sectional survey. All members (7283) of the Sports Physical Therapy Section of the APTA were recruited. A scenario-based survey using pre-participation management of an acute or sub-acute ankle sprain was developed. A Select Survey link was distributed via email to participants. Respondents selected a treatment approach based upon options provided. Follow-up questions were asked. The survey was available for two weeks with a follow-up email sent after one week. Question answers were the main outcome measures. Reliability: Cronbach's alpha=>0.9. The SPT response rate = 6.9% (503); responses came from 48 states. Survey results indicated great variability in respondents' approaches to the treatment of an acute and sub-acute ankle sprain. SPT applied cryotherapy with great variability and not always in accordance to the limited research on the TM. Continuing education, application of current research, and additional outcomes based research needs to remain a focus for clinicians. 3.

Stochastic targeted (STAR) glycemic control: design, safety, and performance.

PubMed

Evans, Alicia; Le Compte, Aaron; Tan, Chia-Siong; Ward, Logan; Steel, James; Pretty, Christopher G; Penning, Sophie; Suhaimi, Fatanah; Shaw, Geoffrey M; Desaive, Thomas; Chase, J Geoffrey

2012-01-01

Tight glycemic control (TGC) has shown benefits but has been difficult to achieve consistently. STAR (Stochastic TARgeted) is a flexible, model-based TGC approach that directly accounts for intra- and interpatient variability with a stochastically derived maximum 5% risk of blood glucose (BG) below 72 mg/dl. This research assesses the safety, efficacy, and clinical burden of a STAR TGC controller modulating both insulin and nutrition inputs in virtual and clinical pilot trials. Clinically validated virtual trials using data from 370 patients in the SPRINT (Specialized Relative Insulin and Nutrition Titration) study were used to design the STAR protocol and test its safety, performance, and required clinical effort prior to clinical pilot trials. Insulin and nutrition interventions were given every 1-3 h as chosen by the nurse to allow them to manage workload. Interventions were designed to maximize the overlap of the model-predicted (5-95(th) percentile) range of BG outcomes with the 72-117 mg/dl band and thus provide a maximum 5% risk of BG <72 mg/dl. Interventions were calculated using clinically validated computer models of human metabolism and its variability in critical illness. Carbohydrate intake (all sources) was selected to maximize intake up to 100% of the American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) goal (25 kg/kcal/h). Insulin doses were limited (8 U/h maximum), with limited increases based on current rate (0.5-2.0 U/h). Initial clinical pilot trials involved 3 patients covering ~450 h. Approval was granted by the Upper South A Regional Ethics Committee. Virtual trials indicate that STAR provides similar glycemic control performance to SPRINT with 2-3 h (maximum) measurement intervals. Time in the 72-126 mg/dl and 72-145 mg/dl bands was equivalent for all controllers, indicating that glycemic outcome differences between protocols were only shifted in this range. Safety from hypoglycemia was improved. Importantly, STAR using 2-3 h (maximum) intervention intervals reduced clinical burden up to 30%, which is clinically very significant. Initial clinical trials showed glycemic performance, safety, and management of inter- and intrapatient variability that matched or exceeded the virtual trial results. In virtual trials, STAR TGC provided tight control that maximized the likelihood of BG in a clinically specified glycemic band and reduced hypoglycemia with a maximum 5% (or lower) expected risk of light hypoglycemia (BG <72 mg/dl) via model-based management of intra- and interpatient variability. Clinical workload was self-managed and reduced up to 30% compared with SPRINT. Initial pilot clinical trials matched or exceeded these virtual results. © 2012 Diabetes Technology Society.

Childhood Medical and Behavioral Consequences of Maternal Cocaine Use1

PubMed Central

Singer, Lynn; Farkas, Kathleen; Kliegman, Robert

2014-01-01

Reviewed available studies of the impact of fetal cocaine exposure on child medical and developmental outcome, as well as the current status of clinical psychological interventions and research strategies. Current studies are inconclusive but suggest that prenatal exposure to crack-cocaine can have significant effects on the growth and neurological development of the infant, with the potential of later learning and behavioral disabilities. Social-environmental correlates of maternal cocaine use are confounding factors with known negative effects on child outcome. Large, population-based studies using multivariate analyses are needed to determine the independent effects of cocaine on child outcome relative to other confounding variables. PMID:1382125

[Clinical research IV. Relevancy of the statistical test chosen].

PubMed

Talavera, Juan O; Rivas-Ruiz, Rodolfo

2011-01-01

When we look at the difference between two therapies or the association of a risk factor or prognostic indicator with its outcome, we need to evaluate the accuracy of the result. This assessment is based on a judgment that uses information about the study design and statistical management of the information. This paper specifically mentions the relevance of the statistical test selected. Statistical tests are chosen mainly from two characteristics: the objective of the study and type of variables. The objective can be divided into three test groups: a) those in which you want to show differences between groups or inside a group before and after a maneuver, b) those that seek to show the relationship (correlation) between variables, and c) those that aim to predict an outcome. The types of variables are divided in two: quantitative (continuous and discontinuous) and qualitative (ordinal and dichotomous). For example, if we seek to demonstrate differences in age (quantitative variable) among patients with systemic lupus erythematosus (SLE) with and without neurological disease (two groups), the appropriate test is the "Student t test for independent samples." But if the comparison is about the frequency of females (binomial variable), then the appropriate statistical test is the χ(2).

Food insecurity and CD4% Among HIV+ children in Gaborone, Botswana.

PubMed

Mendoza, Jason A; Matshaba, Mogomotsi; Makhanda, Jeremiah; Liu, Yan; Boitshwarelo, Matshwenyego; Anabwani, Gabriel M

2014-08-01

We investigated the association between household food insecurity (HFI) and CD4% among 2-6-year old HIV+ outpatients (n = 78) at the Botswana-Baylor Children's Clinical Center of Excellence in Gaborone, Botswana. HFI was assessed by a validated survey. CD4% data were abstracted from the medical record. We used multiple linear regression with CD4% (dependent variable), HFI (independent variable), and controlled for sociodemographic and clinical covariates. Multiple linear regression showed a significant main effect for HFI [beta = -0.6, 95% confidence interval (CI): -1.0 to -0.1] and child gender (beta = 5.6, 95% CI: 1.3 to 9.8). Alleviating food insecurity may improve pediatric HIV outcomes in Botswana and similar Sub-Saharan settings.

Recent developments in clopidogrel pharmacology and their relation to clinical outcomes.

PubMed

Gurbel, Paul A; Antonino, Mark J; Tantry, Udaya S

2009-08-01

Oral antiplatelet therapy with clopidogrel and aspirin is an important and widely prescribed strategy to prevent ischemic events in patients with cardiovascular diseases. However, the occurrence of thrombotic events including stent thrombosis is still high (> 10%). Current practice guidelines are mainly based on large-scale trials focusing on clinical endpoints and 'one size fits all' strategies of treating all patients with the same clopidogrel doses. Pharmacodynamic studies have demonstrated that the latter strategy is associated with wide response variability where a substantial percentage of patients show nonresponsivenes. Translational research studies have established the relation between clopidogrel nonresponsivenes or high on-treatment platelet reactivity to adverse clinical events, thereby establishing clopidogrel nonresponsivenes as an important emerging clinical entity. Clopidogrel response variability is primarily a pharmacokinetic phenomenon associated with insufficient active metabolite generation that is secondary to i) limited intestinal absorption affected by an ABCB1 gene polymorphism; ii) functional variability in P450 isoenzyme activity; and iii) a genetic polymorphism of CYP450 isoenzymes. Personalized antiplatelet treatment with higher clopidogrel doses in selected patients or with newer more potent P2Y(12) receptor blockers based on individual platelet function measurement can overcome some of the limitations of current clopidogrel treatment.

Assessment of published models and prognostic variables in epithelial ovarian cancer at Mayo Clinic

PubMed Central

Hendrickson, Andrea Wahner; Hawthorne, Kieran M.; Goode, Ellen L.; Kalli, Kimberly R.; Goergen, Krista M.; Bakkum-Gamez, Jamie N.; Cliby, William A.; Keeney, Gary L.; Visscher, Dan W.; Tarabishy, Yaman; Oberg, Ann L.; Hartmann, Lynn C.; Maurer, Matthew J.

2015-01-01

Objectives Epithelial ovarian cancer (EOC) is an aggressive disease in which first line therapy consists of a surgical staging/debulking procedure and platinum based chemotherapy. There is significant interest in clinically applicable, easy to use prognostic tools to estimate risk of recurrence and overall survival. In this study we used a large prospectively collected cohort of women with EOC to validate currently published models and assess prognostic variables. Methods Women with invasive ovarian, peritoneal, or fallopian tube cancer diagnosed between 2000-2011 and prospectively enrolled into the Mayo Clinic Ovarian Cancer registry were identified. Demographics and known prognostic markers as well as epidemiologic exposure variables were abstracted from the medical record and collected via questionnaire. Six previously published models of overall and recurrence-free survival were assessed for external validity. In addition, predictors of outcome were assessed in our dataset. Results Previously published models validated with a range of c-statistics (0.587-0.827), though application of models containing variables not part of routine practice were somewhat limited by missing data; utilization of all applicable models and comparison of results is suggested. Examination of prognostic variables identified only the presence of ascites and ASA score to be independent predictors of prognosis in our dataset, albeit with marginal gain in prognostic information, after accounting for stage and debulking. Conclusions Existing prognostic models for newly diagnosed EOC showed acceptable calibration in our cohort for clinical application. However, modeling of prospective variables in our dataset reiterates that stage and debulking remain the most important predictors of prognosis in this setting. PMID:25620544

The stigma of having psychological problems: relations with engagement, working alliance, and depression in psychotherapy.

PubMed

Kendra, Matthew S; Mohr, Jonathan J; Pollard, Jeffrey W

2014-12-01

The stigma of having psychological problems is a barrier to seeking mental health treatment, but little research has examined whether this stigma influences the experiences of those in treatment. In a sample of 42 psychotherapy clients, we explored links over the first few sessions between 2 facets of stigma (self-stigma and perceived public stigma) and 3 variables germane to the therapeutic process (depression, working alliance, and engagement). Initial self-stigma (SS) level was positively associated with initial depression, negatively associated with initial working alliance, and unrelated to initial engagement. Initial perceived public stigma (PPS) level was unrelated to initial levels in the 3 outcome variables. Initial SS and PPS levels were both generally unrelated to linear changes in the outcomes over the initial phase of counseling. Relations between stigma and outcome variables often differed within- and between-persons. For example, the association between PPS and engagement was negative at the between-person level but positive at the within-person level. Finally, on average, PPS decreased over the first few sessions but SS remained constant. Such findings may help therapists better understand the role of stigma in their clinical work, and stimulate research examining how to address stigmatization in psychotherapy.

Self-esteem and its relationship to mental health and quality of life in adults with cystic fibrosis.

PubMed

Platten, Melanie Jane; Newman, Emily; Quayle, Ethel

2013-09-01

Research from the general population indicates an important role for self-esteem in mental health, but limited research in this area exists in the cystic fibrosis (CF) literature. This study aimed to explore the predictive value of self-esteem and health-related quality of life (HRQoL) in mental health symptoms in adults with CF. Seventy-four participants, recruited online, completed the Clinical Outcomes in Routine Evaluation-Outcome Measure 34 (CORE-OM), Rosenberg Self-esteem Scale and Cystic Fibrosis Questionnaire-Revised (CFQ-R). Comparably high levels of self-esteem were found, but HRQoL was lower than previous research. Thirty percent of participants scored within the clinical range for mental health difficulty. Hierarchical regression, controlling for gender, explored the value of four CFQ-R subscales (physical, social, emotional and role functioning) and self-esteem in predicting CORE-OM total score. Gender accounted for 8.2% of the variance in mental health scores while the five independent variables accounted for a further 73.0% of variance. Of the five variables, CFQ-R emotional functioning and self-esteem were significant predictors of mental health symptoms. Results are discussed in relation to clinical implications and potential uses for internet technologies to promote socialisation.

Patellar denervation with electrocautery in total knee arthroplasty without patellar resurfacing: a meta-analysis.

PubMed

Cheng, Tao; Zhu, Chen; Guo, Yongyuan; Shi, Sifeng; Chen, Desheng; Zhang, Xianlong

2014-11-01

The impact of patellar denervation with electrocautery in total knee arthroplasty (TKA) on post-operative outcomes has been under debate. This study aims to conduct a meta-analysis and systematic review to compare the benefits and risks of circumpatellar electrocautery with those of non-electrocautery in primary TKAs. Comparative and randomized clinical studies were identified by conducting an electronic search of articles dated up to September 2012 in PubMed, EMBASE, Scopus, and the Cochrane databases. Six studies that focus on a total of 849 knees were analysed. A random-effects model was conducted using the inverse-variance method for continuous variables and the Mantel-Haenszel method for dichotomous variables. There was no significant difference in the incidence of anterior knee pain between the electrocautery and non-electrocautery groups. In term of patellar score and Knee Society Score, circumpatellar electrocautery improved clinical outcomes compared with non-electrocautery in TKAs. The statistical differences were in favour of the electrocautery group but have minimal clinical significance. In addition, the overall complications indicate no statistical significance between the two groups. This study shows no strong evidence either for or against electrocautery compared with non-electrocautery in TKAs. Therapeutic study (systematic review and meta-analysis), Level III.

Quantitative radiomics: impact of stochastic effects on textural feature analysis implies the need for standards

PubMed Central

Nyflot, Matthew J.; Yang, Fei; Byrd, Darrin; Bowen, Stephen R.; Sandison, George A.; Kinahan, Paul E.

2015-01-01

Abstract. Image heterogeneity metrics such as textural features are an active area of research for evaluating clinical outcomes with positron emission tomography (PET) imaging and other modalities. However, the effects of stochastic image acquisition noise on these metrics are poorly understood. We performed a simulation study by generating 50 statistically independent PET images of the NEMA IQ phantom with realistic noise and resolution properties. Heterogeneity metrics based on gray-level intensity histograms, co-occurrence matrices, neighborhood difference matrices, and zone size matrices were evaluated within regions of interest surrounding the lesions. The impact of stochastic variability was evaluated with percent difference from the mean of the 50 realizations, coefficient of variation and estimated sample size for clinical trials. Additionally, sensitivity studies were performed to simulate the effects of patient size and image reconstruction method on the quantitative performance of these metrics. Complex trends in variability were revealed as a function of textural feature, lesion size, patient size, and reconstruction parameters. In conclusion, the sensitivity of PET textural features to normal stochastic image variation and imaging parameters can be large and is feature-dependent. Standards are needed to ensure that prospective studies that incorporate textural features are properly designed to measure true effects that may impact clinical outcomes. PMID:26251842

Quantitative radiomics: impact of stochastic effects on textural feature analysis implies the need for standards.

PubMed

Nyflot, Matthew J; Yang, Fei; Byrd, Darrin; Bowen, Stephen R; Sandison, George A; Kinahan, Paul E

2015-10-01

Image heterogeneity metrics such as textural features are an active area of research for evaluating clinical outcomes with positron emission tomography (PET) imaging and other modalities. However, the effects of stochastic image acquisition noise on these metrics are poorly understood. We performed a simulation study by generating 50 statistically independent PET images of the NEMA IQ phantom with realistic noise and resolution properties. Heterogeneity metrics based on gray-level intensity histograms, co-occurrence matrices, neighborhood difference matrices, and zone size matrices were evaluated within regions of interest surrounding the lesions. The impact of stochastic variability was evaluated with percent difference from the mean of the 50 realizations, coefficient of variation and estimated sample size for clinical trials. Additionally, sensitivity studies were performed to simulate the effects of patient size and image reconstruction method on the quantitative performance of these metrics. Complex trends in variability were revealed as a function of textural feature, lesion size, patient size, and reconstruction parameters. In conclusion, the sensitivity of PET textural features to normal stochastic image variation and imaging parameters can be large and is feature-dependent. Standards are needed to ensure that prospective studies that incorporate textural features are properly designed to measure true effects that may impact clinical outcomes.

Effect of Escitalopram on Hot Flash Interference: A Randomized, Controlled Trial

PubMed Central

Carpenter, Janet S.; Guthrie, Katherine A.; Larson, Joseph C.; Freeman, Ellen W.; Joffe, Hadine; Reed, Susan D.; Ensrud, Kristine E.; LaCroix, Andrea Z.

2012-01-01

Objectives To estimate the effect of escitalopram 10–20 mg/day versus placebo for reducing hot flash interference in daily life and understand correlates and predictors of reductions in hot flash interference, a key measure of quality of life. Design Multi-site, randomized, double-blind, placebo-controlled clinical trial. Patients 205 midlife women (46% African-American) who met criteria participated. Setting MsFLASH clinical sites in Boston, Indianapolis, Oakland, and Philadelphia. Intervention After baseline, women were randomized to 1 pill of escitalopram 10 mg/day (n=104) or placebo (n=101) with follow-up at 4- and 8-weeks. At week 4, those not achieving 50% fewer hot flashes were increased to 2 pills daily (20 mg/day or 2 placebo pills). Main outcome measures The Hot Flash Related Daily Interference Scale; Correlates were variables from hot flash diaries; Predictors were baseline demographics, clinical variables, depression, anxiety, sleep quality, and hot flashes. Results Compared to placebo, escitalopram significantly reduced hot flash interference by 6.0 points at week 4 and 3.4 points at week 8 more than placebo (p=0.012). Reductions in hot flash interference correlated with changes in hot flash diary variables. However, baseline variables did not significantly predict reductions in hot flash interference. Conclusions Escitalopram 10–20mg/day for 8 weeks improves women’s quality of life and this benefit did not vary by demographic, clinical, mood, sleep, or hot flash variables. PMID:22480818

Ranking of patient and surgeons' perspectives for endpoints in randomized controlled trials--lessons learned from the POVATI trial [ISRCTN 60734227].

PubMed

Fischer, Lars; Deckert, Andreas; Diener, Markus K; Zimmermann, Johannes B; Büchler, Markus W; Seiler, Christoph M

2011-10-01

Surgical trials focus mainly on mortality and morbidity rates, which may be not the most important endpoints from the patient's perspective. Evaluation of expectations and needs of patients enrolled in clinical trials can be analyzed using a procedure called ranking. Within the Postsurgical Pain Outcome of Vertical and Transverse Abdominal Incision randomized trial (POVATI), the perspectives of participating patients and surgeons were assessed as well as the influence of the surgical intervention on patients' needs. All included patients of the POVATI trial were asked preoperatively and postoperatively to rank predetermined outcome variables concerning the upcoming surgical procedure (e.g., pain, complication, cosmetic result) hierarchically according to their importance. Preoperatively, the surgeons were asked to do the same. One hundred eighty two out of 200 randomized patients (71 females, 111 males; mean age 59 years) returned the ranking questionnaire preoperatively and 152 patients (67 females, 85 males; mean age 60 years) on the day of discharge. There were no differences between the two groups with respect to the distribution of ranking variables (p > 0.05). Thirty-five surgeons (7 residents, 6 fellows, and 22 consultants) completed the same ranking questionnaire. The order of the four most important ranking variables for both patients and surgeons were death, avoiding of postoperative complications, avoiding of intraoperative complications, and pain. Surgeons ranked the variable "cosmetic result" significantly as more important compared to patients (p = 0.034, Fisher's exact test). Patients and surgeons did not differ in ranking predetermined outcomes in the POVATI trial. Only the variable "cosmetic result" is significantly more important from the surgeon's than from the patient's perspective. Ranking of outcomes might be a beneficial tool and can be a proper addition to RCTs.

Heart rate variability measured early in patients with evolving acute coronary syndrome and 1-year outcomes of rehospitalization and mortality.

PubMed

Harris, Patricia R E; Stein, Phyllis K; Fung, Gordon L; Drew, Barbara J

2014-01-01

This study sought to examine the prognostic value of heart rate variability (HRV) measurement initiated immediately after emergency department presentation for patients with acute coronary syndrome (ACS). Altered HRV has been associated with adverse outcomes in heart disease, but the value of HRV measured during the earliest phases of ACS related to risk of 1-year rehospitalization and death has not been established. Twenty-four-hour Holter recordings of 279 patients with ACS were initiated within 45 minutes of emergency department arrival; recordings with ≥18 hours of sinus rhythm were selected for HRV analysis (number [N] =193). Time domain, frequency domain, and nonlinear HRV were examined. Survival analysis was performed. During the 1-year follow-up, 94 patients were event-free, 82 were readmitted, and 17 died. HRV was altered in relation to outcomes. Predictors of rehospitalization included increased normalized high frequency power, decreased normalized low frequency power, and decreased low/high frequency ratio. Normalized high frequency >42 ms(2) predicted rehospitalization while controlling for clinical variables (hazard ratio [HR] =2.3; 95% confidence interval [CI] =1.4-3.8, P=0.001). Variables significantly associated with death included natural logs of total power and ultra low frequency power. A model with ultra low frequency power <8 ms(2) (HR =3.8; 95% CI =1.5-10.1; P=0.007) and troponin >0.3 ng/mL (HR =4.0; 95% CI =1.3-12.1; P=0.016) revealed that each contributed independently in predicting mortality. Nonlinear HRV variables were significant predictors of both outcomes. HRV measured close to the ACS onset may assist in risk stratification. HRV cut-points may provide additional, incremental prognostic information to established assessment guidelines, and may be worthy of additional study.

Long telomere length predicts poor clinical outcome in esophageal cancer patients.

PubMed

Lv, Yanyan; Zhang, Yong; Li, Xinru; Ren, Xiaojuan; Wang, Meichen; Tian, Sijia; Hou, Peng; Shi, Bingyin; Yang, Qi

2017-02-01

Abnormal telomere length is widely reported in various human cancers, and it is considered to be an important hallmark of cancer. However, there is remarkably little consensus on the value of telomere length in the prognostic evaluation of esophageal cancers. Here, we attempted to determine the association of variable telomere length with clinical outcome of esophageal cancer patients. Using real-time quantitative PCR, we examined relative telomere lengths (RTL) in a cohort of esophageal cancer and normal esophageal tissues, and statistically investigated the association between RTL and clinical outcomes of esophageal cancer patients. The majority of esophageal cancers in this study had longer RTLs as compared to adjacent non-tumor tissues. Enhanced tumor RTL was associated with smoking habit, poor differentiation, advanced tumor stage, lymph node metastasis and cancer related death. In particular, a close relationship between longer RTL and poor survival was fully demonstrated by using cox regression and Kaplan-Maier survival curves. We found frequent telomere elongation in esophageal cancer tissues, and demonstrated longer RTL may be an independent poor prognostic factor for esophageal cancer patients. Copyright © 2016 Elsevier GmbH. All rights reserved.

Industry's efforts: devices and pharmaceuticals.

PubMed

Sanders, C A

1995-11-01

The pharmaceutical industry has been irreversibly affected by the changes occurring in healthcare. Despite the obvious contributions of pharmaceuticals to human health, our customers are demanding that we help the patient and contribute to value, whether it be in terms of cost, clinical outcomes, or quality of life. We are learning to balance the variables to ensure that cost plus quality equals value in the marketplace in three ways: by focusing on the needs of the customers and demonstrating value through outcomes research, by maintaining an emphasis on innovation, and by taking an active role in the public arena to direct the course of our future. Outcomes research proves the value of what we do. Economic data will have to be correlated with clinical data. In addition to standard clinical and economic parameters, we must also provide quality of life data. Collaboration between the academic and the practicing community produces a win-win situation for both parties. Industry and practitioners are bonded together ineluctably in the service of the patient. Working together we can shape our future and the future of our patients.

Recent biologic and genetic advances in neuroblastoma: Implications for diagnostic, risk stratification, and treatment strategies.

PubMed

Newman, Erika A; Nuchtern, Jed G

2016-10-01

Neuroblastoma is an embryonic cancer of neural crest cell lineage, accounting for up to 10% of all pediatric cancer. The clinical course is heterogeneous ranging from spontaneous regression in neonates to life-threatening metastatic disease in older children. Much of this clinical variance is thought to result from distinct pathologic characteristics that predict patient outcomes. Consequently, many research efforts have been focused on identifying the underlying biologic and genetic features of neuroblastoma tumors in order to more clearly define prognostic subgroups for treatment stratification. Recent technological advances have placed emphasis on the integration of genetic alterations and predictive biologic variables into targeted treatment approaches to improve patient survival outcomes. This review will focus on these recent advances and the implications they have on the diagnostic, staging, and treatment approaches in modern neuroblastoma clinical management. Copyright © 2016 Elsevier Inc. All rights reserved.

[Predicting the outcome in severe injuries: an analysis of 2069 patients from the trauma register of the German Society of Traumatology (DGU)].

PubMed

Rixen, D; Raum, M; Bouillon, B; Schlosser, L E; Neugebauer, E

2001-03-01

On hospital admission numerous variables are documented from multiple trauma patients. The value of these variables to predict outcome are discussed controversially. The aim was the ability to initially determine the probability of death of multiple trauma patients. Thus, a multivariate probability model was developed based on data obtained from the trauma registry of the Deutsche Gesellschaft für Unfallchirurgie (DGU). On hospital admission the DGU trauma registry collects more than 30 variables prospectively. In the first step of analysis those variables were selected, that were assumed to be clinical predictors for outcome from literature. In a second step a univariate analysis of these variables was performed. For all primary variables with univariate significance in outcome prediction a multivariate logistic regression was performed in the third step and a multivariate prognostic model was developed. 2069 patients from 20 hospitals were prospectively included in the trauma registry from 01.01.1993-31.12.1997 (age 39 +/- 19 years; 70.0% males; ISS 22 +/- 13; 18.6% lethality). From more than 30 initially documented variables, the age, the GCS, the ISS, the base excess (BE) and the prothrombin time were the most important prognostic factors to predict the probability of death (P(death)). The following prognostic model was developed: P(death) = 1/1 + e(-[k + beta 1(age) + beta 2(GCS) + beta 3(ISS) + beta 4(BE) + beta 5(prothrombin time)]) where: k = -0.1551, beta 1 = 0.0438 with p < 0.0001, beta 2 = -0.2067 with p < 0.0001, beta 3 = 0.0252 with p = 0.0071, beta 4 = -0.0840 with p < 0.0001 and beta 5 = -0.0359 with p < 0.0001. Each of the five variables contributed significantly to the multifactorial model. These data show that the age, GCS, ISS, base excess and prothrombin time are potentially important predictors to initially identify multiple trauma patients with a high risk of lethality. With the base excess and prothrombin time value, as only variables of this multifactorial model that can be therapeutically influenced, it might be possible to better guide early and aggressive therapy.

Advanced statistics: linear regression, part I: simple linear regression.

PubMed

Marill, Keith A

2004-01-01

Simple linear regression is a mathematical technique used to model the relationship between a single independent predictor variable and a single dependent outcome variable. In this, the first of a two-part series exploring concepts in linear regression analysis, the four fundamental assumptions and the mechanics of simple linear regression are reviewed. The most common technique used to derive the regression line, the method of least squares, is described. The reader will be acquainted with other important concepts in simple linear regression, including: variable transformations, dummy variables, relationship to inference testing, and leverage. Simplified clinical examples with small datasets and graphic models are used to illustrate the points. This will provide a foundation for the second article in this series: a discussion of multiple linear regression, in which there are multiple predictor variables.

Menstrual versus clinical estimate of gestational age dating in the United States: temporal trends and variability in indices of perinatal outcomes.

PubMed

Ananth, Cande V

2007-09-01

Accurate estimation of gestational age early in pregnancy is paramount for obstetric care decisions and for determining fetal growth and other conditions that may necessitate timing the iatrogenic intervention or delivery. We sought to examine temporal changes in the distributions of two measures of gestational age, namely, those based on menstrual dating and a clinical estimate. We further sought to evaluate relative comparisons and variability in indices of perinatal outcomes. We utilised the Natality data files in the US, 1990-2002 comprising women that delivered a singleton livebirth between 22 and 44 weeks gestation (n = 42 689 603). Changes were shown in the distributions of gestational age based on menstrual vs. clinical estimate between 1990 and 2002, as well as changes in the proportions of preterm (<37, <32 and <28 weeks) and post-term (>or=42 weeks) birth, and small- (SGA; <10th percentile) and large-for-gestational-age (LGA; birthweight >90th percentile) births. While the absolute rates of preterm birth <37 weeks, SGA and LGA births were lower based on the clinical estimate of gestational age relative to that based on menstrual dating, the increases in preterm birth rate between 1990 and 2002 were fairly similar between the two measures of gestational dating. However, the decline in post-term births was larger, based on the clinical estimate (-73.8%), than on the menstrual estimate (-36.6%) between 1990 and 2002. While the clinical estimate of gestational age appears to provide a reasonably good approximation to the menstrual estimate, disregarding the clinical estimate of gestational age may ignore the advantages of gestational age assessment in modern obstetrics.

Leveraging prognostic baseline variables to gain precision in randomized trials

PubMed Central

Colantuoni, Elizabeth; Rosenblum, Michael

2015-01-01

We focus on estimating the average treatment effect in a randomized trial. If baseline variables are correlated with the outcome, then appropriately adjusting for these variables can improve precision. An example is the analysis of covariance (ANCOVA) estimator, which applies when the outcome is continuous, the quantity of interest is the difference in mean outcomes comparing treatment versus control, and a linear model with only main effects is used. ANCOVA is guaranteed to be at least as precise as the standard unadjusted estimator, asymptotically, under no parametric model assumptions and also is locally semiparametric efficient. Recently, several estimators have been developed that extend these desirable properties to more general settings that allow any real-valued outcome (e.g., binary or count), contrasts other than the difference in mean outcomes (such as the relative risk), and estimators based on a large class of generalized linear models (including logistic regression). To the best of our knowledge, we give the first simulation study in the context of randomized trials that compares these estimators. Furthermore, our simulations are not based on parametric models; instead, our simulations are based on resampling data from completed randomized trials in stroke and HIV in order to assess estimator performance in realistic scenarios. We provide practical guidance on when these estimators are likely to provide substantial precision gains and describe a quick assessment method that allows clinical investigators to determine whether these estimators could be useful in their specific trial contexts. PMID:25872751

Measuring motivation in schizophrenia: Is a general state of motivation necessary for task-specific motivation?

PubMed Central

Choi, Jimmy; Choi, Kee-Hong; Reddy, Felice; Fiszdon, Joanna M.

2014-01-01

Despite the important role of motivation in rehabilitation and functional outcomes in schizophrenia, to date, there has been little emphasis on how motivation is assessed. This is important, since different measures may tap potentially discrete motivational constructs, which in turn may have very different associations to important outcomes. In the current study, we used baseline data from 71 schizophrenia spectrum outpatients enrolled in a rehabilitation program to examine the relationship between task-specific motivation, as measured by the Intrinsic Motivation Inventory (IMI), and a more general state of volition/initiation, as measured by the three item Quality of Life (QLS) motivation index. We also examined the relationship of these motivation measures to demographic, clinical and functional variables relevant to rehabilitation outcomes. The two motivation measures were not correlated, and participants with low general state motivation exhibited a full range of task-specific motivation. Only the QLS motivation index correlated with variables relevant to rehabilitation outcomes. The lack of associations between QLS motivation index and IMI subscales suggests that constructs tapped by these measures may be divergent in schizophrenia, and specifically that task-specific intrinsic motivation is not contingent on a general state of motivation. That is, even in individuals with a general low motivational state (i.e. amotivation), interventions aimed at increasing task-specific motivation may still be effective. Moreover, the pattern of interrelationships between the QLS motivation index and variables relevant to psychosocial rehabilitation supports its use in treatment outcome studies. PMID:24529609

Patterns and Predictors of Change in Outcome Measures in Clinical Trials in Scleroderma An Individual Patient Meta-Analysis of 629 Subjects with Diffuse Scleroderma

PubMed Central

Merkel, PA; Silliman, NP; Clements, PJ; Denton, CP; Furst, DE; Mayes, MD; Pope, JE; Polisson, RP; Streisand, JB; Seibold, JR

2012-01-01

Purpose To examine the range and responsiveness to change of clinical outcome measures and study the predictors of clinical response for patients with diffuse cutaneous systemic sclerosis (dcSSc) in the context of clinical trials. Methods Data from 629 patients with dcSSc who participated in 7 multicenter clinical therapeutic trials were combined. Trials used common outcome measures: modified Rodnan skin score (MRSS), the Health Assessment Questionnaire (HAQ), Patient Global Assessment (PtGA), pulmonary function tests (FVC, DLCO), and oral aperture (OAp). Results The combined database included 629 patients: 82% women; mean age = 46.5 ± 11.8 years (range 15–82) with disease duration (months): mean: 19.4 ± 15.9, median = 47.0, range 1.0–144.0. Outcomes tended to improve during trials for patients with more severe disease at study entry and worsen for patients with less severe disease at entry. There were weak negative correlations between baseline values and change over 6 months for MRSS (r = −0.17; p<.0001), HAQ (r = −0.15; p= .002), and PtGA (r = −0.44; p<.0001). Baseline FVC and OAp did not predict change in 6 months. Baseline DLCO values were positively correlated with change in DLCO at 6 months (r= −0.32; p<.0001). Disease duration was mildly negatively predictive of change in MRSS at 6 months (r = −0.27; p<.0001) and substantial bidirectional variation in change in MRSS and HAQ was seen over the spectrum of disease duration. 63% of patients with “early” disease (<18 months) had a decline in MRSS and 37% had an increase in MRSS. 81% of patients with late disease (≥ 18 months) had a decline in MRSS and 19% had an increase in MRSS. 53% of patients with early disease had a decline in HAQ and 47% had an increase in HAQ. 51% of patients with late disease had a decline in HAQ and 49% had an increase in HAQ. Multivariate mixed models did not demonstrate that any baseline variables were strongly predictive of subsequent outcome. These results did not differ when comparing trials of early vs. late disease or trial “completers” vs. “non-completers”. Conclusions Among patients with dcSSc enrolled in clinical trials, standard outcome measures tend to improve for patients with more severe disease at study entry and worsen for patients with less severe disease at entry. Overall, MRSS scores improve during observation periods while HAQ and lung function are mostly static, although there are wide variations in individual changes in these measures. None of these variables, including disease duration, reliably identify groups of subjects whose MRSS will predictably increase or decrease in the course of a clinical trial. These findings have important implications for clinical trial design in scleroderma. PMID:22328195

Pediatric Ventilator-Associated Infections: The Ventilator-Associated INfection Study.

PubMed

Willson, Douglas F; Hoot, Michelle; Khemani, Robinder; Carrol, Christopher; Kirby, Aileen; Schwarz, Adam; Gedeit, Rainer; Nett, Sholeen T; Erickson, Simon; Flori, Heidi; Hays, Spencer; Hall, Mark

2017-01-01

Suspected ventilator-associated infection is the most common reason for antibiotics in the PICU. We sought to characterize the clinical variables associated with continuing antibiotics after initial evaluation for suspected ventilator-associated infection and to determine whether clinical variables or antibiotic treatment influenced outcomes. Prospective, observational cohort study conducted in 47 PICUs in the United States, Canada, and Australia. Two hundred twenty-nine pediatric patients ventilated more than 48 hours undergoing respiratory secretion cultures were enrolled as "suspected ventilator-associated infection" in a prospective cohort study, those receiving antibiotics of less than or equal to 3 days were categorized as "evaluation only," and greater than 3 days as "treated." Demographics, diagnoses, comorbidities, culture results, and clinical data were compared between evaluation only and treated subjects and between subjects with positive versus negative cultures. PICUs in 47 hospitals in the United States, Canada, and Australia. All patients undergoing respiratory secretion cultures during the 6 study periods. None. Treated subjects differed from evaluation-only subjects only in frequency of positive cultures (79% vs 36%; p < 0.0001). Subjects with positive cultures were more likely to have chronic lung disease, tracheostomy, and shorter PICU stay, but there were no differences in ventilator days or mortality. Outcomes were similar in subjects with positive or negative cultures irrespective of antibiotic treatment. Immunocompromise and higher Pediatric Logistic Organ Dysfunction scores were the only variables associated with mortality in the overall population, but treated subjects with endotracheal tubes had significantly lower mortality. Positive respiratory cultures were the primary determinant of continued antibiotic treatment in children with suspected ventilator-associated infection. Positive cultures were not associated with worse outcomes irrespective of antibiotic treatment although the lower mortality in treated subjects with endotracheal tubes is notable. The necessity of continuing antibiotics for a positive respiratory culture in suspected ventilator-associated infection requires further study.

An exploration of predictors of children's nurses' attitudes, knowledge, confidence and clinical behavioural intentions towards children and young people who self-harm.

PubMed

Carter, Tim; Latif, Asam; Callaghan, Patrick; Manning, Joseph C

2018-03-22

To explore the potential predictors of children's nurses' attitudes, knowledge and confidence towards caring for children and young people admitted to hospital with self-harm. Admissions to paediatric inpatient settings for individuals who have self-harmed are growing. Limited previous research suggests that nurses have mixed attitudes towards people who have self-harmed and potentially lack the confidence to provide effective care. There is a specific paucity of research in this area for children's nurses. A cross-sectional descriptive survey was used to gather data for exploration of variables associated with attitudes, confidence, knowledge and clinical behavioural intentions of 98 registered children's nurses in a single tertiary children's hospital, colocated in a large acute NHS Trust in the UK. Data were collected over a 4 weeks in 2015, using an online survey tool. The predictive effect of several demographic variables was tested on the outcomes of attitudes, knowledge, confidence and behavioural intentions, which were collected using relevant, previously used outcome measures. Increased experience was found to be associated with improved attitudes relating to negativity. Previous training in caring for children who had self-harmed was found to be associated with improved attitudes around perceived effectiveness of their care. Higher academic qualifications and having undertaken previous training on self-harm were each found to be associated with increased knowledge of self-harm, and increased age was associated with reduced knowledge of self-harm. This study provides an initial exploration of variables associated with attitudes, knowledge, confidence and behaviour intentions of registered children's nurses in relation to caring for CYP who have self-harmed. Targeted training on caring for CYP who have self-harmed should be considered as a component of continuing education for registered children's nurses in the UK to improve the experience and outcomes for this patient group. ©2018 The Authors Journal of Clinical Nursing Published by John Wiley & Sons Ltd.

University clinic and private practice treatment outcomes in Class I extraction and nonextraction patients: A comparative study with the American Board of Orthodontics Objective Grading System.

PubMed

Mislik, Barbara; Konstantonis, Dimitrios; Katsadouris, Alexios; Eliades, Theodore

2016-02-01

The aim of this study was to compare treatment outcomes in university vs private practice settings with Class I patients using the American Board of Orthodontics Objective Grading System. A parent sample of 580 Class I patients treated with and without extractions of 4 first premolars was subjected to discriminant analysis to identify a borderline spectrum of 66 patients regarding the extraction modality. Of these patients, 34 were treated in private orthodontic practices, and 32 were treated in a university graduate orthodontic clinic. The treatment outcomes were evaluated using the 8 variables of the American Board of Orthodontics Objective Grading System. The total scores ranged from 10 to 47 (mean, 25.44; SD, 9.8) for the university group and from 14 to 45 (mean, 25.94; SD, 7.7) for the private practice group. The university group achieved better scores for the variables of buccolingual inclination (mean difference, 2.28; 95% confidence interval [CI], 0.59, 3.98; P = 0.01) and marginal ridges (mean difference, 1.32; 95% CI, 0.28, 2.36; P = 0.01), and the private practice group achieved a better score for the variable of root angulation (mean difference, -0.65; 95% CI, -1.26, -0.03; P = 0.04). However, no statistically intergroup differences were found between the total American Board of Orthodontics Objective Grading System scores (mean difference, -0.5; 95% CI, -3.82, 4.82; P = 0.82). Patients can receive similar quality of orthodontic treatment in a private practice and a university clinic. The orthodontists in the private practices were more successful in angulating the roots properly, whereas the orthodontic residents accomplished better torque control of the posterior segments and better marginal ridges. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Clinical Scenarios for Discordant Anti-Xa

PubMed Central

Vera-Aguilera, Jesus; Yousef, Hindi; Beltran-Melgarejo, Diego; Teng, Teng Hugh; Jan, Ramos; Mok, Mary; Vera-Aguilera, Carlos; Moreno-Aguilera, Eduardo

2016-01-01

Anti-Xa test measures the activity of heparin against the activity of activated coagulation factor X; significant variability of anti-Xa levels in common clinical scenarios has been observed. Objective. To review the most common clinical settings in which anti-Xa results can be bias. Evidence Review. Guidelines and current literature search: we used PubMed, Medline, Embase, and MEDION, from 2000 to October 2013. Results. Anti-Xa test is widely used; however the assay underestimates heparin concentration in the presence of significant AT deficiency, pregnancy, end stage renal disease, and postthrombolysis and in patients with hyperbilirubinemia; limited published data evaluating the safety and effectiveness of anti-Xa assays for managing UH therapy is available. Conclusions and Relevance. To our knowledge this is the first paper that summarizes the most common causes in which this assay can be affected, several “day to day” clinical scenarios can modify the outcomes, and we concur that these rarely recognized scenarios can be affected by negative outcomes in the daily practice. PMID:27293440

A Descriptive Study of Nursing Peer-Review Programs in US Magnet® Hospitals.

PubMed

Roberts, Holli; Cronin, Sherill Nones

2017-04-01

The goal of this study was to assess the types of nursing peer review (NPR) programs in US Magnet® organizations. The 2 most predominant models of NPR programs in the literature are performance evaluation and clinical peer review. The literature on clinical peer review is primarily descriptive, outlining structures and anecdotal outcomes. Participants from hospitals holding Magnet recognition were selected using a stratified random-sampling method. A survey developed by the researchers assessed the presence of NPR. If clinical NPR was in place, program design, evaluation measurements, and barriers were explored. Findings suggest wide variability in NPR models. More than one-third of the respondents conduct peer evaluation as the only mechanism of NPR. Most hospitals with a clinical peer-review program reported a case review structure and process measurements not supported by data. The variations noted in this study suggest more research is needed to measure the effectiveness of NPR models and associated outcomes.

Systolic blood pressure variability in patients with early severe sepsis or septic shock: a prospective cohort study.

PubMed

Tang, Yi; Sorenson, Jeff; Lanspa, Michael; Grissom, Colin K; Mathews, V J; Brown, Samuel M

2017-06-17

Severe sepsis and septic shock are often lethal syndromes, in which the autonomic nervous system may fail to maintain adequate blood pressure. Heart rate variability has been associated with outcomes in sepsis. Whether systolic blood pressure (SBP) variability is associated with clinical outcomes in septic patients is unknown. The propose of this study is to determine whether variability in SBP correlates with vasopressor independence and mortality among septic patients. We prospectively studied patients with severe sepsis or septic shock, admitted to an intensive care unit (ICU) with an arterial catheter. We analyzed SBP variability on the first 5-min window immediately following ICU admission. We performed principal component analysis of multidimensional complexity, and used the first principal component (PC 1 ) as input for Firth logistic regression, controlling for mean systolic pressure (SBP) in the primary analyses, and Acute Physiology and Chronic Health Evaluation (APACHE) II score or NEE dose in the ancillary analyses. Prespecified outcomes were vasopressor independence at 24 h (primary), and 28-day mortality (secondary). We studied 51 patients, 51% of whom achieved vasopressor independence at 24 h. Ten percent died at 28 days. PC 1 represented 26% of the variance in complexity measures. PC 1 was not associated with vasopressor independence on Firth logistic regression (OR 1.04; 95% CI: 0.93-1.16; p = 0.54), but was associated with 28-day mortality (OR 1.16, 95% CI: 1.01-1.35, p = 0.040). Early SBP variability appears to be associated with 28-day mortality in patients with severe sepsis and septic shock.

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

PubMed

Brubaker, Linda; Litman, Heather J; Kim, Hae-Young; Zimmern, Philippe; Dyer, Keisha; Kusek, John W; Richter, Holly E; Stoddard, Anne

2015-08-01

Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

Clinical and radiological features of Marchiafava–Bignami disease

PubMed Central

Dong, Xiaoyu; Bai, Chaobo; Nao, Jianfei

2018-01-01

Abstract Marchiafava–Bignami disease (MBD) is a rare neurological disease usually associated with chronic alcoholism and characterized by demyelination and necrosis. Our aims were to describe the clinicoradiological features and identify factors that may affect the prognosis of patients with MBD. We examined clinical manifestations, laboratory results, and neuroradiological features of 9 patients with MBD. The patients were classified into 2 subgroups (favorable and poor outcome subgroups) based on the Modified Oxford Handicap Scale (MOSH). In addition, we compared the clinical and neuroimaging features between the 2 subgroups. Nine adult male patients (age of onset range 37–62 years, with a mean age of 47.00 ± 14.50 years) were included in this study. According to MOSH, 4 patients were placed in the poor outcome subgroup (MOHS ≥ 3), 5 patients were placed in the favorable outcome subgroup (MOHS ≤ 2). Relatively high score of MAST-C (≥6) (P = .008), extracallosal lesions (P = .048), GCS (P = .026), cerebral lobe impairment (P = .048) was significantly more common in the poor outcome subgroup. Clinical manifestations of MBD are variable and lack specificity. Early diagnosis by relatively specific performance of bisymmetric lesions in corpus callosum of diffusion-weighted imaging (DWI) may affect the prognosis. The prognosis of patients with severe disturbance of consciousness, heavy alcohol consumption, extracallosal lesions, cerebral lobe impairment is probably unfavorable. PMID:29384842

Calcium supplementation improves clinical outcome in intensive care unit patients: a propensity score matched analysis of a large clinical database MIMIC-II.

PubMed

Zhang, Zhongheng; Chen, Kun; Ni, Hongying

2015-01-01

Observational studies have linked hypocalcemia with adverse clinical outcome in critically ill patients. However, calcium supplementation has never been formally investigated for its beneficial effect in critically ill patients. To investigate whether calcium supplementation can improve 28-day survival in adult critically ill patients. Secondary analysis of a large clinical database consisting over 30,000 critical ill patients was performed. Multivariable analysis was performed to examine the independent association of calcium supplementation and 28-day morality. Furthermore, propensity score matching technique was employed to investigate the role of calcium supplementation in improving survival. none. Primary outcome was the 28-day mortality. 90-day mortality was used as secondary outcome. A total of 32,551 adult patients, including 28,062 survivors and 4489 non-survivors (28-day mortality rate: 13.8 %) were included. Calcium supplementation was independently associated with improved 28-day mortality after adjusting for confounding variables (hazard ratio: 0.51; 95 % CI 0.47-0.56). Propensity score matching was performed and the after-matching cohort showed well balanced covariates. The results showed that calcium supplementation was associated with improved 28- and 90-day mortality (p < 0.05 for both Log-rank test). In adult critically ill patients, calcium supplementation during their ICU stay improved 28-day survival. This finding supports the use of calcium supplementation in critically ill patients.

Effect of sports modification on clinical outcome in children and adolescent athletes with symptomatic lumbar spondylolysis.

PubMed

El Rassi, Georges; Takemitsu, Masakazu; Glutting, Joseph; Shah, Suken A

2013-12-01

This cohort study aimed to report the compliance of young athletes with nonoperative treatment and to clarify the role of sports modification on clinical outcome of symptomatic spondylolysis. This study included patients with a chief complaint of low back pain participating in regular sports activity, having spondylolysis, and being treated and followed up between 1990 and 2002 in the authors' hospital. One hundred thirty-two athletes were included in this study: 78 males and 54 females. The mean age of the patients was 13 yrs (range, 7-18 yrs). Only 56 patients (42.4%) were compliant to nonoperative treatment. Eighty-six patients (65%) stopped all sports activities for at least 3 mos, and 46 patients (35%) stopped exercising for a variable period of less than 3 mos. The grading of clinical outcome after nonoperative treatment was as follows: excellent in 48 patients (36.4%), good in 74 patients (56.1), fair in 6 patients (4.5%), and poor in 4 patients (3%). The patients who stopped sports for at least 3 mos were 16.39 times more likely to have an excellent result than those who did not stop sports. Bony healing on radiographs did not correlate with clinical outcome. Timely cessation of sports activity for 3 mos is considered an effective method of nonoperative treatment for young athletes with symptomatic lumbar spondylolysis.

Waist-hip ratio and 1-year clinical outcome in patients with non-ST-elevation myocardial infarctions.

PubMed

Lee, Hye Won; Hong, Taek Jong; Hong, Ju Young; Choi, Jong Hyun; Kim, Bo Won; Ahn, Jinhee; Park, Jin Sup; Oh, Jun-Hyok; Choi, Jung Hyun; Lee, Han Cheol; Cha, Kwang Soo

2016-08-01

Obesity is a well-known cardiovascular disease risk factor. We evaluated the relationship between the waist-hip ratio (WHR), as a surrogate marker of central obesity, and clinical outcomes in patients with non-ST-segment elevation myocardial infarctions (NSTEMIs) undergoing percutaneous coronary interventions (PCIs). Between 2008 and 2010, NSTEMI patients who underwent PCI and who had available anthropometric data were divided into three groups according to their WHR tertile range. Clinical outcomes in the groups were analyzed. Increasing incidences of hypertension and diabetes mellitus were associated with increasing WHR. As the WHR increased, a disintegration of patient metabolic patterns was documented in laboratory findings. There was no difference in the 1-year mortality rates between the three groups. However, increasing 1-year major adverse cardiovascular event rates were documented as the WHR increased (13, 14.7, and 19.4% in tertile groups 1-3, respectively; P=0.005). After adjusting for confounding variables, the highest tertile group was associated with increased 1-year mortality and major adverse cardiovascular event rates compared with the lowest tertile group. These differences arose from the female subgroup, suggesting that the magnitude of the central obesity effect might be greater in female than in male patients. Central obesity, represented by WHR, was associated with poor clinical outcomes in NSTEMI patients undergoing PCI, particularly among women.

Treatment of Anxiety in Patients with Coronary Heart Disease: Rationale and Design of the UNWIND Randomized Clinical Trial

PubMed Central

Blumenthal, James A.; Feger, Bryan J.; Smith, Patrick J.; Watkins, Lana L.; Jiang, Wei; Davidson, Jonathan; Hoffman, Benson M.; Ashworth, Megan; Mabe, Stephanie K.; Babyak, Michael A.; Kraus, William E.; Hinderliter, Alan; Sherwood, Andrew

2016-01-01

Background Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety. Methods The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3×/wk, 35 min, 70–85% VO2peak), escitalopram (5–20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A1c, heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life. Conclusions The UNWIND trial (ClinicalTrials.gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients. PMID:27264220

Objectives and Design of the Hemodialysis Fistula Maturation Study

PubMed Central

Dember, Laura M.; Imrey, Peter B.; Beck, Gerald J.; Cheung, Alfred K.; Himmelfarb, Jonathan; Huber, Thomas S.; Kusek, John W.; Roy-Chaudhury, Prabir; Vazquez, Miguel A.; Alpers, Charles E.; Robbin, Michelle L.; Vita, Joseph A.; Greene, Tom; Gassman, Jennifer J.; Feldman, Harold I.

2014-01-01

Background A large proportion of newly created arteriovenous fistulas cannot be used for dialysis because they fail to mature adequately to support the hemodialysis blood circuit. The Hemodialysis Fistula Maturation (HFM) Study was designed to elucidate clinical and biological factors associated with fistula maturation outcomes. Study Design Multicenter prospective cohort study. Setting & Participants Approximately 600 patients undergoing creation of a new hemodialysis fistula will be enrolled at 7 centers in the United States and followed up for as long as 4 years. Predictors Clinical, anatomical, biological, and process-of-care attributes identified pre-operatively, intra-operatively, or post-operatively. Outcomes The primary outcome is unassisted clinical maturation defined as successful use of the fistula for dialysis for four weeks without any maturation-enhancing procedures. Secondary outcomes include assisted clinical maturation, ultrasound-based anatomical maturation, fistula procedures, fistula abandonment, and central venous catheter use. Measurements Pre-operative ultrasound arterial and venous mapping, flow-mediated and nitroglycerin-mediated brachial artery dilation, arterial pulse wave velocity, and venous distensibility; intra-operative vein tissue collection for histopathological and molecular analyses; post-operative ultrasounds at 1 day, 2 weeks, 6 weeks, and prior to fistula intervention and initial cannulation. Results Assuming complete data, no covariate adjustment, and unassisted clinical maturation of 50%, there will be 80% power to detect ORs of 1.83 and 1.61 for dichotomous predictor variables with exposure prevalences of 20% and 50%, respectively. Limitations Exclusion of two-stage transposition fistulas limits generalizability. The requirement for study visits may result in a cohort that is healthier than the overall population of patients undergoing fistula creation. Conclusions The HFM Study will be of sufficient size and scope to 1) evaluate a broad range of mechanistic hypotheses, 2) identify clinical practices associated with maturation outcomes, 3) assess the predictive utility of early indicators of fistula outcome, and 4) establish targets for novel therapeutic interventions to improve fistula maturation. PMID:23992885

Provider-Hospital “Fit” and Patient Outcomes: Evidence from Massachusetts Cardiac Surgeons, 2002–2004

PubMed Central

Huesch, Marco D

2011-01-01

Objective To examine whether the “fit” of a surgeon with hospital resources impacts cardiac surgery outcomes, separately from hospital or surgeon effects. Data Sources Retrospective secondary data from the Massachusetts Department of Public Health's Data Analysis Center, on all 12,983 adult isolated coronary artery bypass surgical admissions in state-regulated hospitals from 2002 through 2004. Clinically audited chart data was collected using Society of Thoracic Surgeons National Cardiac Surgery Database tools and cross-referenced with administrative discharge data in the Division of Health Care Finance and Policy. Mortality was followed up through 2007 via the state vital statistics registry. Study Design Analysis was at the patient level for those receiving isolated coronary artery bypass surgery (CABG). Sixteen outcomes included 30-day mortality, major morbidity, indicators of perioperative, and predischarge processes of care. Hierarchical crossed mixed models were used to estimate fixed covariate and random effects at hospital, surgeon, and hospital × surgeon level. Principal Findings Hospital volume was associated with significantly reduced intraoperative durations and significantly increased probability of aspirin, β-blocker, and lipid-lowering discharge medication use. The proportion of outcome variability due to unobserved hospital × surgeon interaction effects was small but meaningful for intraoperative practices, discharge destination, and medication use. For readmissions and mortality within 30 days or 1 year, unobserved patient and hospital factors drove almost all variability in outcomes. Conclusions Among Massachusetts patients receiving isolated CABG, consistent evidence was found that the hospital × surgeon combination independently impacted patient outcomes, beyond hospital or surgeon effects. Such distinct local interactions between a surgeon and hospital resources may play an important part in moderating quality improvement efforts, although residual patient-level factors generally contributed the most to outcome variability. PMID:20849555

Outcome of bone mineral density in anorexia nervosa patients 11.7 years after first admission.

PubMed

Herzog, W; Minne, H; Deter, C; Leidig, G; Schellberg, D; Wüster, C; Gronwald, R; Sarembe, E; Kröger, F; Bergmann, G

1993-05-01

Osteopenia is a typical finding in patients suffering from anorexia nervosa. Unfortunately, available longitudinal studies are limited by a relatively short follow-up period. Therefore cross-sectional long-term followup studies may help to determine both the outcome of this bone lesion and variables that influence its subsequent development. Of an initial 66 consecutive patients with anorexia nervosa, 51 (77.3%) could be further evaluated. After an average of 11.7 years following first admission, cross-sectional measurements of lumbar and proximal radial bone mineral density (BMD) were performed. The ability to predict BMD using variables obtained from anamnestic and clinical data was then determined by multiple-regression analysis. The BMD of both radial and lumbar bone in anorexic patients with poor disease outcome (as defined by the Morgan-Russell general outcome categories) deviated by -2.18 and -1.73 SD (Z score), respectively. In patients with a good disease outcome lumbar BMD was significantly less reduced compared with radial BMD (-0.26 versus -0.68 SD). Variables reflecting estrogen deficiency and nutritional status in the course of the disease, that is, relative estrogen exposure (for lumbar BMD) and years of anorexia nervosa (for radial BMD), allowed the best prediction of BMD. A marked reduction in cortical and trabecular BMD in anorexic patients with poor disease outcome suggests a higher risk of fractures in these patients. Furthermore, the finding of a persistently reduced cortical and a slightly reduced trabecular BMD, even in patients with good disease outcome, suggests that a recovery of trabecular BMD might be possible, at least in part. Recovery of cortical bone, if possible at all, seems to proceed more slowly.

Populations and outcome measures used in ongoing research in sarcopenia.

PubMed

Peña Ordóñez, Gloria Gabriela; Bustamante Montes, Lilia Patricia; Ramírez Duran, Ninfa; Sánchez Castellano, Carmen; Cruz-Jentoft, Alfonso J

2017-08-01

Sarcopenia research may be hampered by the heterogeneity of populations and outcome measures used in clinical studies. The aim of this study was to describe the inclusion/exclusion criteria and outcome measures used in ongoing research in sarcopenia. All active intervention studies registered in the World Health Organization with the keyword sarcopenia were included. Study design, type of intervention, inclusion/exclusion criteria and outcome measures were registered and classified. In April 2014, 151 studies on sarcopenia were registered in the WHO database. One hundred twenty-three were intervention studies. Most trials (94.3 %) were single centre and randomized (93.5 %), 51.2 % were double blind. Nutritional interventions (36.6 %), physical exercise (12.2 %) or both (19.5 %) were the most common interventions tested. Only 54.4 % included subjects of both genders, and 46.3 % had an upper age limit. Definition of the target populations was heterogeneous, with 57.7 % including healthy subjects and none using recent definitions of sarcopenia. Lifestyle and the degree of physical activity of subjects were not described or considered in most cases (79.7 %). Subjects with cardiovascular, neuropsychiatric or metabolic disorders and those with physical disability were usually excluded. Muscle mass and muscle strength were the primary outcome variables in 28.5 and 29.5 % of studies and physical performance in 19.5 %, but only 4.1 % used the three variables used the three of them. An additional 26.8 % used biological outcome variables. Little information and agreement existed in the way muscle and physical performance parameters were measured. We found a large heterogeneity in trial design, definition of populations and outcome measures in present research.

Warfarin therapy: in need of improvement after all these years

PubMed Central

Kimmel, Stephen E

2010-01-01

Background Warfarin therapy has been used clinically for over 60 years, yet continues to be problematic because of its narrow therapeutic index and large inter-individual variability in patient response. As a result, warfarin is a leading cause of serious medication-related adverse events, and its efficacy is also suboptimal. Objective To review factors that are responsible for variable response to warfarin, including clinical, environmental, and genetic factors, and to explore some possible approaches to improving warfarin therapy. Results Recent efforts have focused on developing dosing algorithms that included genetic information to try to improve warfarin dosing. These dosing algorithms hold promise, but have not been fully validated or tested in rigorous clinical trials. Perhaps equally importantly, adherence to warfarin is a major problem that should be addressed with innovative and cost-effective interventions. Conclusion Additional research is needed to further test whether interventions can be used to improve warfarin dosing and outcomes. PMID:18345947

Glycaemic variability in patients with severe sepsis or septic shock admitted to an Intensive Care Unit.

PubMed

Silveira, L M; Basile-Filho, A; Nicolini, E A; Dessotte, C A M; Aguiar, G C S; Stabile, A M

2017-08-01

Sepsis is associated with morbidity and mortality, which implies high costs to the global health system. Metabolic alterations that increase glycaemia and glycaemic variability occur during sepsis. To verify mean body glucose levels and glycaemic variability in Intensive Care Unit (ICU) patients with severe sepsis or septic shock. Retrospective and exploratory study that involved collection of patients' sociodemographic and clinical data and calculation of severity scores. Glycaemia measurements helped to determine glycaemic variability through standard deviation and mean amplitude of glycaemic excursions. Analysis of 116 medical charts and 6730 glycaemia measurements revealed that the majority of patients were male and aged over 60 years. Surgical treatment was the main reason for ICU admission. High blood pressure and diabetes mellitus were the most usual comorbidities. Patients that died during the ICU stay presented the highest SOFA scores and mean glycaemia; they also experienced more hypoglycaemia events. Patients with diabetes had higher mean glycaemia, evaluated through standard deviation and mean amplitude of glycaemia excursions. Organic impairment at ICU admission may underlie glycaemic variability and lead to a less favourable outcome. High glycaemic variability in patients with diabetes indicates that monitoring of these individuals is crucial to ensure better outcomes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Overview of clinical research design.

PubMed

Hartung, Daniel M; Touchette, Daniel

2009-02-15

Basic concepts and terminology of clinical research design are presented for new clinical investigators. Clinical research, research involving human subjects, can be described as either observational or experimental. The findings of all clinical research can be threatened by issues of bias and confounding. Biases are systematic errors in how study subjects are selected or measured, which result in false inferences. Confounding is a distortion in findings that is attributable to mixing variable effects. Uncontrolled observation research is generally more prone to bias and confounding than experimental research. Observational research includes designs such as the cohort study, case-control study, and cross-sectional study, while experimental research typically involves a randomized controlled trial (RCT). The cohort study, which includes the RCT, defines subject allocation on the basis of exposure interest (e.g., drug, disease-management program) and follows the patients to assess the outcomes. The case-control study uses the primary outcome of interest (e.g., adverse event) to define subject allocation, and different exposures are assessed in a retrospective manner. Cross-sectional research evaluates both exposure and outcome concurrently. Each of these design methods possesses different strengths and weaknesses in answering research questions, as well as underlying many study subtypes. While experimental research is the strongest method for establishing causality, it can be difficult to accomplish under many scenarios. Observational clinical research offers many design alternatives that may be appropriate if planned and executed carefully.

Stock Versus CAD/CAM Customized Zirconia Implant Abutments - Clinical and Patient-Based Outcomes in a Randomized Controlled Clinical Trial.

PubMed

Schepke, Ulf; Meijer, Henny J A; Kerdijk, Wouter; Raghoebar, Gerry M; Cune, Marco

2017-02-01

Single-tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. This randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant abutments with respect to preservation of marginal bone level and several clinical and patient-based outcome measures. Fifty participants with a missing premolar were included and randomly assigned to standard (ZirDesign, DentsplySirona Implants, Mölndal, Sweden) or computer aided design/computer aided manufacturing (CAD/CAM) customized (Atlantis, DentsplySirona Implants, Mölndal, Sweden) zirconia abutment therapy. Peri-implant bone level (primary outcome), Plaque-index, calculus formation, bleeding on probing, gingiva index, probing pocket depth, recession, appearance of soft tissues and patients' contentment were assessed shortly after placement and one year later. No implants were lost and no complications related to the abutments were observed. Statistically significant differences between stock and CAD/CAM customized zirconia abutments could not be demonstrated for any of the operationalized variables. The use of a CAD/CAM customized zirconia abutment in single tooth replacement of a premolar is not associated with an improvement in clinical performance or patients' contentment when compared to the use of a stock zirconia abutment. © 2016 The Authors. Clinical Implant Dentistry and Related Research Published by Wiley Periodicals, Inc.

ZAP-70 staining in chronic lymphocytic leukemia.

PubMed

Villamor, Neus

2005-05-01

Chronic lymphocytic leukemia (CLL) is the most common chronic leukemia in Western countries. The disease has an extremely variable clinical course, and several prognostic features have been identified to assess individual risk. The configuration of the immunoglobulin variable heavy-chain gene (IgV(H)) is a strong predictor of the outcome. CLL patients with unmutated IgV(H) status have an aggressive clinical course and a short survival. Unfortunately, analysis of IgV(H) gene configuration is not available in most clinical laboratories. A small number of genes are differentially expressed between unmutated IgV(H) and mutated IgV(H) clinical forms of CLL. One of these genes is ZAP-70, which is detected in leukemic cells from patients with the unmutated IgV(H) form of CLL. Flow cytometry presents advantages over other methods to detect ZAP-70, and its quantification by flow cytometry has proved its predictive value. This unit focuses on protocols to quantify ZAP-70 by flow cytometry in CLL.

Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project): a clinical trial by clusters.

PubMed

Del Cura-González, Isabel; López-Rodríguez, Juan A; Sanz-Cuesta, Teresa; Rodríguez-Barrientos, Ricardo; Martín-Fernández, Jesús; Ariza-Cardiel, Gloria; Polentinos-Castro, Elena; Román-Crespo, Begoña; Escortell-Mayor, Esperanza; Rico-Blázquez, Milagros; Hernández-Santiago, Virginia; Azcoaga-Lorenzo, Amaya; Ojeda-Ruiz, Elena; González-González, Ana I; Ávila-Tomas, José F; Barrio-Cortés, Jaime; Molero-García, José M; Ferrer-Peña, Raul; Tello-Bernabé, María Eugenia; Trujillo-Martín, Mar

2016-05-17

Clinical practice guidelines (CPGs) have been developed with the aim of helping health professionals, patients, and caregivers make decisions about their health care, using the best available evidence. In many cases, incorporation of these recommendations into clinical practice also implies a need for changes in routine clinical practice. Using educational games as a strategy for implementing recommendations among health professionals has been demonstrated to be effective in some studies; however, evidence is still scarce. The primary objective of this study is to assess the effectiveness of a teaching strategy for the implementation of CPGs using educational games (e-learning EDUCAGUIA) to improve knowledge and skills related to clinical decision-making by residents in family medicine. The primary objective will be evaluated at 1 and 6 months after the intervention. The secondary objectives are to identify barriers and facilitators for the use of guidelines by residents of family medicine and to describe the educational strategies used by Spanish teaching units of family and community medicine to encourage implementation of CPGs. We propose a multicenter clinical trial with randomized allocation by clusters of family and community medicine teaching units in Spain. The sample size will be 394 residents (197 in each group), with the teaching units as the randomization unit and the residents comprising the analysis unit. For the intervention, both groups will receive an initial 1-h session on clinical practice guideline use and the usual dissemination strategy by e-mail. The intervention group (e-learning EDUCAGUIA) strategy will consist of educational games with hypothetical clinical scenarios in a virtual environment. The primary outcome will be the score obtained by the residents on evaluation questionnaires for each clinical practice guideline. Other included variables will be the sociodemographic and training variables of the residents and the teaching unit characteristics. The statistical analysis will consist of a descriptive analysis of variables and a baseline comparison of both groups. For the primary outcome analysis, an average score comparison of hypothetical scenario questionnaires between the EDUCAGUIA intervention group and the control group will be performed at 1 and 6 months post-intervention, using 95 % confidence intervals. A linear multilevel regression will be used to adjust the model. The identification of effective teaching strategies will facilitate the incorporation of available knowledge into clinical practice that could eventually improve patient outcomes. The inclusion of information technologies as teaching tools permits greater learning autonomy and allows deeper instructor participation in the monitoring and supervision of residents. The long-term impact of this strategy is unknown; however, because it is aimed at professionals undergoing training and it addresses prevalent health problems, a small effect can be of great relevance. ClinicalTrials.gov: NCT02210442 .

Intrafamilial variability in the clinical manifestations of mucopolysaccharidosis type II: Data from the Hunter Outcome Survey (HOS)

PubMed Central

Giugliani, Roberto; Harmatz, Paul; Mendelsohn, Nancy J.; Jego, Virginie; Parini, Rossella

2017-01-01

Several cases of phenotypic variability among family members with mucopolysaccharidosis type II (MPS II) have been reported, but the data are limited. Data from patients enrolled in the Hunter Outcome Survey (HOS) were used to investigate intrafamilial variability in male siblings with MPS II. As of July 2015, data were available for 78 patients aged ≥5 years at last visit who had at least one affected sibling (39 sibling pairs). These patients were followed prospectively (i.e., they were alive at enrollment in HOS). The median age at the onset of signs and symptoms was the same for the elder and younger brothers (2.0 years); however, the younger brothers were typically diagnosed at a younger age than the elder brothers (median age, 2.5 and 5.1 years, respectively). Of the 39 pairs, eight pairs were classified as being discordant (the status of four or more signs and symptoms differed between the siblings); 21 pairs had one, two, or three signs and symptoms that differed between the siblings, and 10 pairs had none. Regression status of the majority of the developmental milestones studied was generally concordant among siblings. Functional classification, a measure of central nervous system involvement, was the same in 24/28 pairs, although four pairs were considered discordant as functional classification differed between the siblings. Overall, this analysis revealed similarity in the clinical manifestations of MPS II among siblings. This information should help to improve our understanding of the clinical presentation of the disease, including phenotype prediction in affected family members. PMID:29210515

Big data and computational biology strategy for personalized prognosis.

PubMed

Ow, Ghim Siong; Tang, Zhiqun; Kuznetsov, Vladimir A

2016-06-28

The era of big data and precision medicine has led to accumulation of massive datasets of gene expression data and clinical information of patients. For a new patient, we propose that identification of a highly similar reference patient from an existing patient database via similarity matching of both clinical and expression data could be useful for predicting the prognostic risk or therapeutic efficacy.Here, we propose a novel methodology to predict disease/treatment outcome via analysis of the similarity between any pair of patients who are each characterized by a certain set of pre-defined biological variables (biomarkers or clinical features) represented initially as a prognostic binary variable vector (PBVV) and subsequently transformed to a prognostic signature vector (PSV). Our analyses revealed that Euclidean distance rather correlation distance measure was effective in defining an unbiased similarity measure calculated between two PSVs.We implemented our methods to high-grade serous ovarian cancer (HGSC) based on a 36-mRNA predictor that was previously shown to stratify patients into 3 distinct prognostic subgroups. We studied and revealed that patient's age, when converted into binary variable, was positively correlated with the overall risk of succumbing to the disease. When applied to an independent testing dataset, the inclusion of age into the molecular predictor provided more robust personalized prognosis of overall survival correlated with the therapeutic response of HGSC and provided benefit for treatment targeting of the tumors in HGSC patients.Finally, our method can be generalized and implemented in many other diseases to accurately predict personalized patients' outcomes.

Analysis and Application of the Concept of Modesty to Breastfeeding

PubMed Central

Moran, Meghan

1999-01-01

Modesty may be a significant variable impacting breast- feeding outcomes in western cultures, yet this term has received minimal attention in the breastfeeding literature. An analysis of the concept of modesty was conducted to gain greater understanding of the potential impact of modesty on breastfeeding outcomes. Various uses of the term modesty and particularly modesty in the context of breastfeeding are discussed in this paper. The defining attributes of breastfeeding modesty are identified and examples are provided. Implications for research and clinical practice are suggested. PMID:22988417

Preliminary definition of improvement in juvenile arthritis.

PubMed

Giannini, E H; Ruperto, N; Ravelli, A; Lovell, D J; Felson, D T; Martini, A

1997-07-01

To identify a core set of outcome variables for the assessment of children with juvenile arthritis (JA), to use the core set to develop a definition of improvement to determine whether individual patients demonstrate clinically important improvement, and to promote this definition as a single efficacy measure in JA clinical trials. A core set of outcome variables was established using a combination of statistical and consensus formation techniques. Variables in the core set consisted of 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate. To establish a definition of improvement using this core set, 21 pediatric rheumatologists from 14 countries met, and, using consensus formation techniques, scored each of 72 patient profiles as improved or not improved. Using the physicians' consensus as the gold standard, the chi-square, sensitivity, and specificity were calculated for each of 240 possible definitions of improvement. Definitions with sensitivity or specificity of <80% were eliminated. The ability of the remaining definitions to discriminate between the effects of active agent and those of placebo, using actual trial data, was then observed. Each definition was also ranked for face validity, and the sum of the ranks was then multiplied by the kappa statistic. The definition of improvement with the highest final score was as follows: at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by >30%. The second highest scoring definition was closely related to the first; the third highest was similar to the Paulus criteria used in adult rheumatoid arthritis trials, except with different variables. This indicates convergent validity of the process used. We propose a definition of improvement for JA. Use of a uniform definition will help standardize the conduct and reporting of clinical trials, and should help practitioners decide if a child with JA has responded adequately to therapy. We are in the process of prospectively validating this definition and several others that scored highly.

Bupropion for the treatment of apathy in Huntington’s disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial

PubMed Central

Gelderblom, Harald; Wüstenberg, Torsten; McLean, Tim; Mütze, Lisanne; Fischer, Wilhelm; Saft, Carsten; Hoffmann, Rainer; Süssmuth, Sigurd; Schlattmann, Peter; van Duijn, Erik; Landwehrmeyer, Bernhard; Priller, Josef

2017-01-01

Objective To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Methods In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI). Results At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator. Conclusion Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD. Trial registration ClinicalTrials.gov 01914965 PMID:28323838

Targeting aspirin in acute disabling ischemic stroke: an individual patient data meta-analysis of three large randomized trials.

PubMed

Thompson, Douglas D; Murray, Gordon D; Candelise, Livia; Chen, Zhengming; Sandercock, Peter A G; Whiteley, William N

2015-10-01

Aspirin is of moderate overall benefit for patients with acute disabling ischemic stroke. It is unclear whether functional outcome could be improved after stroke by targeting aspirin to patients with a high risk of recurrent thrombosis or a low risk of haemorrhage. We aimed to determine whether patients at higher risk of thrombotic events or poor functional outcome, or lower risk of major haemorrhage had a greater absolute risk reduction of poor functional outcome with aspirin than the average patient. We used data on individual ischemic stroke patients from three large trials of aspirin vs. placebo in acute ischemic stroke: the first International Stroke Trial (n = 18,372), the Chinese Acute Stroke Trial (n = 20,172) and the Multicentre Acute Stroke Trial (n = 622). We developed and evaluated clinical prediction models for the following: early thrombotic events (myocardial infarction, ischemic stroke, deep vein thrombosis and pulmonary embolism); early haemorrhagic events (significant intracranial haemorrhage, major extracranial haemorrhage, or haemorrhagic transformation of an infarct); and late poor functional outcome. We calculated the absolute risk reduction of poor functional outcome (death or dependence) at final follow-up in: quartiles of early thrombotic risk; quartiles of early haemorrhagic risk; and deciles of poor functional outcome risk. Ischemic stroke patients who were older, had lower blood pressure, computerized tomography evidence of infarct or more severe deficits due to stroke had increased risk of thrombotic and haemorrhagic events and poor functional outcome. Prediction models built with all baseline variables (including onset to treatment time) discriminated weakly between patients with and without recurrent thrombotic events (area under the receiver operating characteristic curve 0·56, 95% CI:0·53-0·59) and haemorrhagic events (0·57, 0·52-0·64), though well between patients with and without poor functional outcome (0·77, 0·76-0·78) in the International Stroke Trial. We found no evidence that the net benefit of aspirin increased with increasing risk of thrombosis, haemorrhage or poor functional outcome in all three trials. Using simple clinical variables to target aspirin to patients after acute disabling stroke by risk of thrombosis, haemorrhage or poor functional outcome does not lead to greater net clinical benefit. We suggest future risk stratification schemes include new risk factors for thrombosis and intracranial haemorrhage. © 2015 The Authors. International Journal of Stroke published by John Wiley & Sons Ltd on behalf of World Stroke Organization.

Decision tree analysis in subarachnoid hemorrhage: prediction of outcome parameters during the course of aneurysmal subarachnoid hemorrhage using decision tree analysis.

PubMed

Hostettler, Isabel Charlotte; Muroi, Carl; Richter, Johannes Konstantin; Schmid, Josef; Neidert, Marian Christoph; Seule, Martin; Boss, Oliver; Pangalu, Athina; Germans, Menno Robbert; Keller, Emanuela

2018-01-19

OBJECTIVE The aim of this study was to create prediction models for outcome parameters by decision tree analysis based on clinical and laboratory data in patients with aneurysmal subarachnoid hemorrhage (aSAH). METHODS The database consisted of clinical and laboratory parameters of 548 patients with aSAH who were admitted to the Neurocritical Care Unit, University Hospital Zurich. To examine the model performance, the cohort was randomly divided into a derivation cohort (60% [n = 329]; training data set) and a validation cohort (40% [n = 219]; test data set). The classification and regression tree prediction algorithm was applied to predict death, functional outcome, and ventriculoperitoneal (VP) shunt dependency. Chi-square automatic interaction detection was applied to predict delayed cerebral infarction on days 1, 3, and 7. RESULTS The overall mortality was 18.4%. The accuracy of the decision tree models was good for survival on day 1 and favorable functional outcome at all time points, with a difference between the training and test data sets of < 5%. Prediction accuracy for survival on day 1 was 75.2%. The most important differentiating factor was the interleukin-6 (IL-6) level on day 1. Favorable functional outcome, defined as Glasgow Outcome Scale scores of 4 and 5, was observed in 68.6% of patients. Favorable functional outcome at all time points had a prediction accuracy of 71.1% in the training data set, with procalcitonin on day 1 being the most important differentiating factor at all time points. A total of 148 patients (27%) developed VP shunt dependency. The most important differentiating factor was hyperglycemia on admission. CONCLUSIONS The multiple variable analysis capability of decision trees enables exploration of dependent variables in the context of multiple changing influences over the course of an illness. The decision tree currently generated increases awareness of the early systemic stress response, which is seemingly pertinent for prognostication.

Single-row, double-row, and transosseous equivalent techniques for isolated supraspinatus tendon tears with minimal atrophy: A retrospective comparative outcome and radiographic analysis at minimum 2-year followup

PubMed Central

McCormick, Frank; Gupta, Anil; Bruce, Ben; Harris, Josh; Abrams, Geoff; Wilson, Hillary; Hussey, Kristen; Cole, Brian J.

2014-01-01

Purpose: The purpose of this study was to measure and compare the subjective, objective, and radiographic healing outcomes of single-row (SR), double-row (DR), and transosseous equivalent (TOE) suture techniques for arthroscopic rotator cuff repair. Materials and Methods: A retrospective comparative analysis of arthroscopic rotator cuff repairs by one surgeon from 2004 to 2010 at minimum 2-year followup was performed. Cohorts were matched for age, sex, and tear size. Subjective outcome variables included ASES, Constant, SST, UCLA, and SF-12 scores. Objective outcome variables included strength, active range of motion (ROM). Radiographic healing was assessed by magnetic resonance imaging (MRI). Statistical analysis was performed using analysis of variance (ANOVA), Mann — Whitney and Kruskal — Wallis tests with significance, and the Fisher exact probability test <0.05. Results: Sixty-three patients completed the study requirements (20 SR, 21 DR, 22 TOE). There was a clinically and statistically significant improvement in outcomes with all repair techniques (ASES mean improvement P = <0.0001). The mean final ASES scores were: SR 83; (SD 21.4); DR 87 (SD 18.2); TOE 87 (SD 13.2); (P = 0.73). There was a statistically significant improvement in strength for each repair technique (P < 0.001). There was no significant difference between techniques across all secondary outcome assessments: ASES improvement, Constant, SST, UCLA, SF-12, ROM, Strength, and MRI re-tear rates. There was a decrease in re-tear rates from single row (22%) to double-row (18%) to transosseous equivalent (11%); however, this difference was not statistically significant (P = 0.6). Conclusions: Compared to preoperatively, arthroscopic rotator cuff repair, using SR, DR, or TOE techniques, yielded a clinically and statistically significant improvement in subjective and objective outcomes at a minimum 2-year follow-up. Level of Evidence: Therapeutic level 3. PMID:24926159

Quantitative Stratification of Diffuse Parenchymal Lung Diseases

PubMed Central

Raghunath, Sushravya; Rajagopalan, Srinivasan; Karwoski, Ronald A.; Maldonado, Fabien; Peikert, Tobias; Moua, Teng; Ryu, Jay H.; Bartholmai, Brian J.; Robb, Richard A.

2014-01-01

Diffuse parenchymal lung diseases (DPLDs) are characterized by widespread pathological changes within the pulmonary tissue that impair the elasticity and gas exchange properties of the lungs. Clinical-radiological diagnosis of these diseases remains challenging and their clinical course is characterized by variable disease progression. These challenges have hindered the introduction of robust objective biomarkers for patient-specific prediction based on specific phenotypes in clinical practice for patients with DPLD. Therefore, strategies facilitating individualized clinical management, staging and identification of specific phenotypes linked to clinical disease outcomes or therapeutic responses are urgently needed. A classification schema consistently reflecting the radiological, clinical (lung function and clinical outcomes) and pathological features of a disease represents a critical need in modern pulmonary medicine. Herein, we report a quantitative stratification paradigm to identify subsets of DPLD patients with characteristic radiologic patterns in an unsupervised manner and demonstrate significant correlation of these self-organized disease groups with clinically accepted surrogate endpoints. The proposed consistent and reproducible technique could potentially transform diagnostic staging, clinical management and prognostication of DPLD patients as well as facilitate patient selection for clinical trials beyond the ability of current radiological tools. In addition, the sequential quantitative stratification of the type and extent of parenchymal process may allow standardized and objective monitoring of disease, early assessment of treatment response and mortality prediction for DPLD patients. PMID:24676019

A meta-analysis of multicultural competencies and psychotherapy process and outcome.

PubMed

Tao, Karen W; Owen, Jesse; Pace, Brian T; Imel, Zac E

2015-07-01

For decades, psychologists have emphasized the provision of multiculturally competent psychotherapy to reduce racial and ethnic disparities in mental health treatment. However, the relationship between multicultural competencies (MC) and other measures of clinical process and treatment outcome has shown heterogeneity in effect sizes. This meta-analysis tested the association of client ratings of therapist MC with measures of therapeutic processes and outcome, including: (a) working alliance, (b) client satisfaction, (c) general counseling competence, (d) session impact, and (e) symptom improvement. Among 18 studies (20 independent samples) included in the analysis, the correlation between therapist MC and outcome (r = .29) was much smaller than the association with process measures (r = .75), but there were no significant differences in correlations across different types of MC or clinical process measures. Providing some evidence of publication bias, effect sizes from published studies (r = .67) were larger than those from unpublished dissertations (r = .28). Moderator analyses indicated that client age, gender, the representation of racial-ethnic minority (R-EM) clients, and clinical setting were not associated with effect size variability. Based on these findings, we discuss implications and recommendations for future research that might lead to a better understanding of the effects of therapist MC on treatment process and outcome. Primary needs in future research include the development and evaluation of observer ratings of therapist MC and the implementation of longitudinal research designs. (c) 2015 APA, all rights reserved).

Patient-Related Benefits for Adults with Cochlear Implantation: A Multicultural Longitudinal Observational Study

PubMed Central

Lenarz, Thomas; Muller, Lida; Czerniejewska-Wolska, Hanna; Vallés Varela, Hector; Orús Dotú, César; Durko, Marcin; Huarte Irujo, Alicia; Piszczatowski, Bartosz; Zadrożniak, Marek; Irwin, Colin; Graham, Petra L.; Wyss, Josie

2017-01-01

Objectives To assess subjectively perceived, real-world benefits longitudinally for unilateral cochlear implant (CI) recipients in a multinational population treated routinely. To identify possible predictors of self-reported benefits. Design This was a prospective, multicenter, repeated-measures study. Self-assessment of performance at preimplantation and postimplantation at 1, 2, and 3 years using standardized, validated, local language versions of the Speech, Spatial, and Qualities of Hearing Scale (SSQ), and the Health Utilities Index Mark 3 (HUI3) was performed. Outcomes were analyzed using a longitudinal mixed-effects model incorporating country effect. Patient demographics were explored for associations with change over time. Subjects Two hundred ninety-one routinely treated, unilateral CI recipients, aged 137–81 years, from 9 clinics across 4 countries. Results Highly significant improvements were observed for all outcome measures (p < 0.0001). Postimplantation, mean outcome scores remained stable beyond 1 year, with notable individual variability. A significant association for one or more outcomes with preimplantation contralateral hearing aid use, telephone use, age at implantation, implantation side, preimplantation comorbidities, dizziness, and tinnitus was observed (p < 0.004). Conclusions Longitudinal benefits of CI treatment can be measured using clinically standardized self-assessment tools to provide a holistic view of patient-related benefits in routine clinical practice for aggregated data from multinational populations. Self-reported outcomes can provide medical-based evidence regarding CI treatment to support decision-making by health service providers. PMID:28719901

Determination of colonoscopy indication from administrative claims data.

PubMed

Ko, Cynthia W; Dominitz, Jason A; Neradilek, Moni; Polissar, Nayak; Green, Pam; Kreuter, William; Baldwin, Laura-Mae

2014-04-01

Colonoscopy outcomes, such as polyp detection or complication rates, may differ by procedure indication. To develop methods to classify colonoscopy indications from administrative data, facilitating study of colonoscopy quality and outcomes. We linked 14,844 colonoscopy reports from the Clinical Outcomes Research Initiative, a national repository of endoscopic reports, to the corresponding Medicare Carrier and Outpatient File claims. Colonoscopy indication was determined from the procedure reports. We developed algorithms using classification and regression trees and linear discriminant analysis (LDA) to classify colonoscopy indication. Predictor variables included ICD-9CM and CPT/HCPCS codes present on the colonoscopy claim or in the 12 months prior, patient demographics, and site of colonoscopy service. Algorithms were developed on a training set of 7515 procedures, then validated using a test set of 7329 procedures. Sensitivity was lowest for identifying average-risk screening colonoscopies, varying between 55% and 86% for the different algorithms, but specificity for this indication was consistently over 95%. Sensitivity for diagnostic colonoscopy varied between 77% and 89%, with specificity between 55% and 87%. Algorithms with classification and regression trees with 7 variables or LDA with 10 variables had similar overall accuracy, and generally lower accuracy than the algorithm using LDA with 30 variables. Algorithms using Medicare claims data have moderate sensitivity and specificity for colonoscopy indication, and will be useful for studying colonoscopy quality in this population. Further validation may be needed before use in alternative populations.

Pharmacokinetic variability, efficacy and tolerability of eslicarbazepine acetate-A national approach to the evaluation of therapeutic drug monitoring data and clinical outcome.

PubMed

Svendsen, Torleiv; Brodtkorb, Eylert; Reimers, Arne; Molden, Espen; Sætre, Erik; Johannessen, Svein I; Johannessen Landmark, Cecilie

2017-01-01

Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED), still insufficiently studied regarding pharmacokinetic variability, efficacy and tolerability. The purpose of this study was to evaluate therapeutic drug monitoring (TDM) data in Norway and relate pharmacokinetic variability to clinical efficacy and tolerability in a long-term clinical setting in patients with refractory epilepsy. This retrospective observational study included TDM-data from the main laboratories and population data from the Norwegian Prescription Database in Norway, in addition to clinical data from medical records of adult patients using ESL for up to three years, whenever possible. TDM-data from 168 patients were utilized for assessment of pharmacokinetic variability, consisting of 71% of the total number of patients in Norway using ESL, 2011-14. Median daily dose of ESL was 800mg (range 400-1600mg), and median serum concentration of ESL was 53μmol/L (range 13-132μmol/L). Inter-patient variability of ESL was extensive, with 25-fold variability in concentration/dose ratios. Additional clinical data were available from 104 adult patients out of the 168, all with drug resistant focal epilepsy. After 1, 2 and 3 years follow-up, the retention rate of ESL was 83%, 72% and 64%, respectively. ESL was generally well tolerated as add-on treatment, but sedation, cognitive impairment and hyponatremia were reported. Hyponatremia (sodium <137mmol/L) was present in 36% of the patients, and lead to discontinuation in three. Pharmacokinetic variability of ESL was extensive and the demonstration of usefulness of TDM requires further studies. In patients with drug resistant focal Epilepsy, the high retention rate indicated good efficacy and tolerability. Hyponatremia was observed in one third of the patients. The present results point to a need for individualization of treatment and TDM may be useful. Copyright © 2016 Elsevier B.V. All rights reserved.

An analysis of the predictors of mortality and morbidity in patients admitted after suicidal hanging to an Indian multidisciplinary Intensive Care Unit

PubMed Central

Renuka, MK; Kalaiselvan, MS; Arunkumar, AS

2017-01-01

Background and Aims: Hanging is a frequently used method to attempt suicide in India. There is a lack of data in the Indian population regarding clinical features and outcomes of suicidal hanging. The purpose of this study was to evaluate the factors affecting mortality and morbidity in patients admitted with suicidal hanging to the Intensive Care Unit (ICU). Methods: A 6-year retrospective study of adult patients admitted to the ICU with suicidal hanging was analysed for demographics, mode of hanging, lead time to emergency room (ER) admission, clinical presentation, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores, admission Glasgow coma scale (GCS) and neurological outcomes. The primary outcome was in-hospital mortality rate. Secondary outcomes were hospital length of stay (LOS), ICU-LOS, time for neurological recovery, organ support and duration of mechanical ventilation. Statistical analysis was performed using the Student's t-test for continuous variables and Chi-square test for categorical variables. Results: We analysed data of 106 patients. The median age was 27 years [Interquartile Range (IQR) (22–34)]. The median lead time to ER admission was 1 h [IQR (0.5–1.4)] with median ICU stay of 3 days [IQR (2–4)]. Vasopressors were administered to 27.4% patients. GCS was ≤7 in 65% patients, and 84.9% patients received mechanical ventilation. Mortality rate was 10.3%. Survivors recovered with normal organ function. Conclusion: Suicidal hanging is associated with significant mortality. Admission GCS, APACHE II and 48 h SOFA score were predictors of poor outcome. PMID:28794524

The prognostic value of formal thought disorder following first episode psychosis.

PubMed

Roche, Eric; Lyne, John; O'Donoghue, Brian; Segurado, Ricardo; Behan, Caragh; Renwick, Laoise; Fanning, Felicity; Madigan, Kevin; Clarke, Mary

2016-12-01

Formal thought disorder (FTD) is associated with poor outcome in established psychotic illnesses and it can be assessed as a categorical or dimensional variable. However, its influence on functional outcome and hospitalisation patterns in early psychosis has not been investigated. We evaluated the relationship between FTD and these outcomes in a first episode psychosis (FEP) sample. A mixed diagnostic FEP cohort was recruited through an Early Intervention in Psychosis Service in Ireland. Participants were assessed at initial presentation and one year later with the MIRECC GAF to evaluate social and occupational functioning domains. Disorganisation (disFTD), verbosity (verFTD) and poverty (povFTD) dimensions of FTD were examined at both time points, as well as a unitary FTD construct. Analyses were controlled for demographic, clinical and treatment variables. DisFTD was the only FTD dimension associated with functional outcome, specifically social functioning, on multivariate analysis (beta=0.13, P<0.05). The unitary FTD construct was not associated with functional outcome. DisFTD at FEP presentation predicted a greater number of hospitalisations (adjusted beta=0.24, P<0.001) and prolonged inpatient admission (adjusted OR=1.08, 95% CI 1.02-1.15, P<0.05) following FEP. Longitudinal and dimensional evaluation of FTD has a clinical utility that is distinct from a cross-sectional or unitary assessment. Dimensions of FTD may map onto different domains of functioning. These findings are supportive of some of the changes in DSM-V with an emphasis on longitudinal and dimensional appraisal of psychopathology. Communication disorders may be considered a potential target for intervention in psychotic disorders. Copyright © 2016 Elsevier B.V. All rights reserved.

Serum Chloride and Sodium Interplay in Patients With Acute Myocardial Infarction and Heart Failure With Reduced Ejection Fraction: An Analysis From the High-Risk Myocardial Infarction Database Initiative.

PubMed

Ferreira, João Pedro; Girerd, Nicolas; Duarte, Kevin; Coiro, Stefano; McMurray, John J V; Dargie, Henry J; Pitt, Bertram; Dickstein, Kenneth; Testani, Jeffrey M; Zannad, Faiez; Rossignol, Patrick

2017-02-01

Serum chloride levels were recently found to be independently associated with mortality in heart failure (HF). We investigated the relationship between serum chloride and clinical outcomes in 7195 subjects with acute myocardial infarction complicated by reduced left ventricular function and HF. The studied outcomes were all-cause mortality, cardiovascular mortality, and hospitalization for HF. Both chloride and sodium had a nonlinear association with the studied outcomes (P<0.05 for linearity). Patients in the lowest chloride tertile (chloride ≤100) were older, had more comorbidities, and had lower sodium levels (P<0.05 for all). Serum chloride showed a significant interaction with sodium with regard to all studied outcomes (P for interaction <0.05 for all). The lowest chloride tertile (≤100 mmol/L) was associated with increased mortality rates in the context of lower sodium (≤138 mmol/L; adjusted hazard ratio [95% confidence interval] for all-cause mortality=1.42 (1.14-1.77); P=0.002), whereas in the context of higher sodium levels (>141 mmol/L), the association with mortality was lost. Spline-transformed chloride and its interaction with sodium did not add significant prognostic information on top of other well-established prognostic variables (P>0.05 for all outcomes). In post-myocardial infarction with systolic dysfunction and HF, low serum chloride was associated with mortality (but not hospitalization for HF) in the setting of lower sodium. Overall, chloride and its interaction with sodium did not add clinically relevant prognostic information on top of other well-established prognostic variables. Taken together, these data support an integrated and critical consideration of chloride and sodium interplay. © 2017 American Heart Association, Inc.

Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres

PubMed Central

Pagel, Christina; Utley, Martin; Crowe, Sonya; Witter, Thomas; Anderson, David; Samson, Ray; McLean, Andrew; Banks, Victoria; Tsang, Victor; Brown, Katherine

2013-01-01

Objective To implement routine in-house monitoring of risk-adjusted 30-day mortality following paediatric cardiac surgery. Design Collaborative monitoring software development and implementation in three specialist centres. Patients and methods Analyses incorporated 2 years of data routinely audited by the National Institute of Cardiac Outcomes Research (NICOR). Exclusion criteria were patients over 16 or undergoing non-cardiac or only catheter procedures. We applied the partial risk adjustment in surgery (PRAiS) risk model for death within 30 days following surgery and generated variable life-adjusted display (VLAD) charts for each centre. These were shared with each clinical team and feedback was sought. Results Participating centres were Great Ormond Street Hospital, Evelina Children's Hospital and The Royal Hospital for Sick Children in Glasgow. Data captured all procedures performed between 1 January 2010 and 31 December 2011. This incorporated 2490 30-day episodes of care, 66 of which were associated with a death within 30 days.The VLAD charts generated for each centre displayed trends in outcomes benchmarked to recent national outcomes. All centres ended the 2-year period within four deaths from what would be expected. The VLAD charts were shared in multidisciplinary meetings and clinical teams reported that they were a useful addition to existing quality assurance initiatives. Each centre is continuing to use the prototype software to monitor their in-house surgical outcomes. Conclusions Timely and routine monitoring of risk-adjusted mortality following paediatric cardiac surgery is feasible. Close liaison with hospital data managers as well as clinicians was crucial to the success of the project. PMID:23564473

A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs

PubMed Central

Harman, Robert; Carlson, Kim; Gaynor, Jamie; Gustafson, Scott; Dhupa, Sarit; Clement, Keith; Hoelzler, Michael; McCarthy, Tim; Schwartz, Pamela; Adams, Cheryl

2016-01-01

Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy. PMID:27695698

Industry guidelines, laws and regulations ignored: quality of drug advertising in medical journals.

PubMed

Lankinen, Kari S; Levola, Tero; Marttinen, Kati; Puumalainen, Inka; Helin-Salmivaara, Arja

2004-11-01

To document the quality of evidence base for marketing claims in prescription drug advertisements, to facilitate identification of potential targets for quality improvement. A sample of 1036 advertisements from four major Finnish medical journals published in 2002. Marketing claims were classified in four groups: unambiguous clinical outcome, vague clinical outcome, emotive or immeasurable outcome and non-clinical outcome. Medline references were traced and classified according to the level of evidence available. The statistical variables used in the advertisements were also documented. The sample included 245 distinct advertisements with 883 marketing claims, 1-10 claims per advertisement. Three hundred thirty seven (38%) of the claims were referenced. Each claim could be supported by one reference or more, so the number of references analysed totalled 381, 1-9 references per advertisement. Nine percent of the claims implied unambiguous clinical outcomes, 68% included vague or emotive statements. Twenty one percent of the references were irrelevant to the claim. There was a fair amount of non-scientific and scientific support for the 73 unambiguous claims, but not a single claim was supported by strong scientific evidence. Vague, emotive and non-clinical claims were significantly more often supported by non-Medline or irrelevant references than unambiguous claims. Statistical parameters were stated only 34 times. Referenced marketing claims may appear more scientific, but the use of references does not guarantee the quality of the claims. For the benefit of all stakeholders, both the regulatory control and industry's self-control of drug marketing should adopt more active monitoring roles, and apply sanctions when appropriate. Concerted efforts by several stakeholders might be more effective. Copyright 2004 John Wiley & Sons, Ltd.

Classic and nonclassic HLA class I expression in penile cancer and relation to HPV status and clinical outcome.

PubMed

Djajadiningrat, Rosa S; Horenblas, Simon; Heideman, Daniëlle A M; Sanders, Joyce; de Jong, Jeroen; Jordanova, Ekaterina S

2015-04-01

Loss of expression of HLA class I is a mechanism of immune evasion in various cancers that is often associated with a worse patient outcome. We analyzed HLA expression in a large cohort with penile cancer in relation to clinical outcome. We used penile cancer tissue blocks from 168 patients who underwent surgical resection between 2000 and 2009 to construct tissue microarrays. Immunohistochemical staining was done with antibodies directed against classic and nonclassic HLA molecules. HLA expression was scored semiquantitatively, divided into 3 expression groups and correlated with clinicopathological variables, including HPV and survival. Survival analysis was performed using the Kaplan-Meier method and Cox proportional hazards models. Complete and partial loss of total classic HLA class I was observed in 32% and 50% of cases, and up-regulation of HLA-E and G in 16% and 13%, respectively. When corrected for relevant clinical parameters, partial HLA-A loss was significantly associated with decreased survival overall (HR 2.3, 95% CI 1.1-4.6) and in HPV negative patients alone (HR 3.4, 95% CI 1.4-8.4). Abnormal HLA-B/C, E or G expression levels were not associated with survival. To our knowledge this is the first study to describe a link between HLA expression and the clinical outcome of penile cancer. HLA down-regulation occurs frequently and partial loss of HLA-A is an independent predictor of poor survival in HPV negative patients. Complete understanding of the mechanisms and relevance of HLA down-regulation and immune evasion in regard to the clinical outcome will contribute to the future design of immunotherapy interventions. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

[Clinical presentation, therapeutic approach and outcomes in acute poisoning treated with activated charcoal. Are there differences between men and women?].

PubMed

Amigó-Tadín, Montserrat; Nogué-Xarau, Santiago; Miró-Andreu, Oscar

2010-01-01

To determine whether there are gender-based differences in the clinical presentation, therapeutic approaches and outcomes in acute poisoning treated with activated charcoal. A descriptive study conducted in the Emergency Department of the Hospital Clínic de Barcelona over the 7 years between the years 2001 and 2008. The study included poisoned patients who had received activated charcoal. The variables included, epidemiological data, clinical and toxicological presentation, therapeutic approach, time in emergency department and outcomes. A total of 575 patients were included in the study. The mean age was 37.8 (SD 14.8) years and 65.7% were females. No differences were observed between males and females with respect to age, number of drugs involved in the poisoning or the number of tablets ingested, but a higher prevalence of benzodiazepine poisoning was observed in females compared to males (69.8 vs. 61.2%; P<0.05). Alcohol combined with drug poisoning was more common in males than in females (32.4 vs.18.8%; P<0.001). Administration of activated charcoal in non-drug poisoning was also more common in males than in females (7.9 vs. 3.2%; P<0.05). There were no differences between genders as regards clinical presentation of the poisonings, delays in care, hours of emergency department stay, treatment or outcome. Benzodiazepine poisoning was more prevalent in females than in males. Non-drug poisonings and alcohol combined with drug ingestion were more common in males. The clinical outcomes of the poisonings, delays in care, therapeutic requirements and admissions were similar between genders. Copyright © 2010 Elsevier España, S.L. All rights reserved.

The Value of the SYNTAX Score II in Predicting Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Ryan, Nicola; Nombela-Franco, Luis; Jiménez-Quevedo, Pilar; Biagioni, Corina; Salinas, Pablo; Aldazábal, Andrés; Cerrato, Enrico; Gonzalo, Nieves; Del Trigo, María; Núñez-Gil, Iván; Fernández-Ortiz, Antonio; Macaya, Carlos; Escaned, Javier

2017-11-27

The predictive value of the SYNTAX score (SS) for clinical outcomes after transcatheter aortic valve implantation (TAVI) is very limited and could potentially be improved by the combination of anatomic and clinical variables, the SS-II. We aimed to evaluate the value of the SS-II in predicting outcomes in patients undergoing TAVI. A total of 402 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI were included. Preprocedural TAVI angiograms were reviewed and the SS-I and SS-II were calculated using the SS algorithms. Patients were stratified in 3 groups according to SS-II tertiles. The coprimary endpoints were all-cause death and major adverse cardiovascular events (MACE), a composite of all-cause death, cerebrovascular event, or myocardial infarction at 1 year. Increased SS-II was associated with higher 30-day mortality (P=.036) and major bleeding (P=.015). The 1-year risk of death and MACE was higher among patients in the 3rd SS-II tertile (HR, 2.60; P=.002 and HR, 2.66; P<.001) and was similar among patients in the 2nd tertile (HR, 1.27; P=.507 and HR, 1.05; P=.895) compared with patients in the 1st tertile. The highest SS-II tertile was an independent predictor of long-term mortality (P=.046) and MACE (P=.001). The SS-II seems more suited to predict clinical outcomes in patients undergoing TAVI than the SS-I. Increased SS-II was associated with poorer clinical outcomes at 1 and 4 years post-TAVI, independently of the presence of coronary artery disease. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Home environment, brain injury, & school performance in LBW survivors.

PubMed

Mahoney, Ashley Darcy; Pinto-Martin, Jennifer; Hanlon, Alexandra

2014-01-01

There has been substantial research on low birthweight (LBW) as a predictor of adverse educational and cognitive outcomes. LBW infants perform worse on cognitive battery tests compared to children born at normal birthweight; however, children exposed to similar risks do not all share the same experiences. The complex, interrelated factors responsible for poor cognitive and achievement performance vary for different populations, but researchers hypothesize that the home environment may influence the infants' long-term health outcomes. Examine the home environment as a moderator in the causal pathway from neonatal brain injury to school performance in a secondary analysis of a prospectively studied, geographically defined cohort from the Neonatal Brain Hemorrhage Study. The secondary analysis sample included 543 infants with birthweights of 501 to 2,000 g who were born consecutively in three community hospitals in New Jersey between 1984 and 1986. School performance at age 9 was measured by the Woodcock-Johnson Tests of Achievement. The home environment variables were tested and analyzed using multistep hierarchical regression modeling. A moderating effect between the variable neighborhood observations and brain injury was demonstrated for the outcome math score. The moderating relationship was found in the category of children without brain injury (β = 1.76, p = .005). There were statistically significant and potentially clinical meaningful models when looking at the home environmental variables as they relate to reading and math scores. The findings suggest that at least one variable within a LBW child's socio-environmental milieu can moderate the effects of perinatal brain injury on school performance outcomes.