Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.

PubMed

Massol, Jacques; Janin, Gérard; Bachot, Camille; Gousset, Christophe; Deville, Geoffroy Sainte-Claire; Chalopin, Jean-Marc

2017-02-01

Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS). We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required). The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total. With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS.

Prospective Validation of Pre-earthquake Atmospheric Signals and Their Potential for Short–term Earthquake Forecasting

NASA Astrophysics Data System (ADS)

Ouzounov, Dimitar; Pulinets, Sergey; Hattori, Katsumi; Lee, Lou; Liu, Tiger; Kafatos, Menas

2015-04-01

We are presenting the latest development in multi-sensors observations of short-term pre-earthquake phenomena preceding major earthquakes. Our challenge question is: "Whether such pre-earthquake atmospheric/ionospheric signals are significant and could be useful for early warning of large earthquakes?" To check the predictive potential of atmospheric pre-earthquake signals we have started to validate anomalous ionospheric / atmospheric signals in retrospective and prospective modes. The integrated satellite and terrestrial framework (ISTF) is our method for validation and is based on a joint analysis of several physical and environmental parameters (Satellite thermal infrared radiation (STIR), electron concentration in the ionosphere (GPS/TEC), radon/ion activities, air temperature and seismicity patterns) that were found to be associated with earthquakes. The science rationale for multidisciplinary analysis is based on concept Lithosphere-Atmosphere-Ionosphere Coupling (LAIC) [Pulinets and Ouzounov, 2011], which explains the synergy of different geospace processes and anomalous variations, usually named short-term pre-earthquake anomalies. Our validation processes consist in two steps: (1) A continuous retrospective analysis preformed over two different regions with high seismicity- Taiwan and Japan for 2003-2009 (2) Prospective testing of STIR anomalies with potential for M5.5+ events. The retrospective tests (100+ major earthquakes, M>5.9, Taiwan and Japan) show STIR anomalous behavior before all of these events with false negatives close to zero. False alarm ratio for false positives is less then 25%. The initial prospective testing for STIR shows systematic appearance of anomalies in advance (1-30 days) to the M5.5+ events for Taiwan, Kamchatka-Sakhalin (Russia) and Japan. Our initial prospective results suggest that our approach show a systematic appearance of atmospheric anomalies, one to several days prior to the largest earthquakes That feature could be further studied and tested for prospective early warnings based on the multi-sensors detection of pre-earthquake atmospheric signals.

The Role of Prospective Memory in Medication Adherence: A Review of an Emerging Literature

PubMed Central

Zogg, Jennifer B.; Woods, Steven Paul; Sauceda, John A.; Wiebe, John S.; Simoni, Jane M.

2013-01-01

Although neurocognitive impairment is an established risk factor for medication non-adherence, standard neurocognitive tests developed for clinical purposes may not fully capture the complexities of non-adherence behavior or effectively inform theory-driven interventions. Prospective memory, an innovative cognitive construct describing one’s ability to remember to do something at a later time, is an understudied factor in the detection and remediation of medication non-adherence. This review orients researchers to the construct of prospective memory, summarizes empirical evidence for prospective memory as a risk factor for non-adherence, discusses the relative merits of current measurement techniques, and highlights potential prospective memory-focused intervention strategies. A comprehensive literature review was conducted of published empirical studies investigating prospective memory and medication adherence. Overall, reviewed studies suggest that prospective memory is an important component of medication adherence, providing incremental ecological validity over established predictors. Findings indicate that prospective memory-based interventions might be an effective means of improving adherence. PMID:21487722

Recognition, Accreditation and Validation of Non-Formal and Informal Learning: Prospects for Lifelong Learning in Nepal

ERIC Educational Resources Information Center

Regmi, Kapil Dev

2009-01-01

This study was an exploration on the various issues related to recognition, accreditation and validation of non-formal and informal learning to open up avenues for lifelong learning and continuing education in Nepal. The perceptions, experiences, and opinions of Nepalese Development Activists, Educational Administrators, Policy Actors and…

Cross-Validation of the Computerized Adaptive Screening Test (CAST).

ERIC Educational Resources Information Center

Pliske, Rebecca M.; And Others

The Computerized Adaptive Screening Test (CAST) was developed to provide an estimate at recruiting stations of prospects' Armed Forces Qualification Test (AFQT) scores. The CAST was designed to replace the paper-and-pencil Enlistment Screening Test (EST). The initial validation study of CAST indicated that CAST predicts AFQT at least as accurately…

Validation of the Ottawa Knee Rule in Iran: a prospective study.

PubMed

Jalili, Mohammad; Gharebaghi, Hadi

2010-11-01

This study was designed to determine the accuracy of the Ottawa Knee Rule (OKR) when applied to patients with acute knee injury in the Iranian population of the Imam Hospital Emergency Department (ED) at. This prospective cohort validation study included a convenience sample of all patients with a blunt knee injury sustained in the preceding 7 days presenting to the ED of a tertiary care teaching hospital during the study period. Patients were assessed for the five variables comprising the OKR, and a standardised data form was completed for each patient. Standard knee radiographs were ordered on all patients irrespective of the determination of the rule. The rules were interpreted by the primary investigator on the basis of the data sheet and the final orthopaedist radiograph reading. Outcome measures of this study were: sensitivity, specificity, positive predictive value and negative predictive value of the OKR. A total of 283 patients were enrolled in the study. 22 fractures (7.77%) were detected. The decision rule had a sensitivity of 0.95 (95% CI 0.77 to 0.99), and a specificity of 0.44 (95% CI 0.37 to 0.50). The potential reduction in use of radiography was estimated to be 41%. The OKR missed only one fracture. Prospective validation has shown that the OKR is a highly sensitive tool for detecting knee fractures and has the potential to reduce the number of radiographs in patients with acute knee injuries.

Evaluation and validation of the diagnostic value of the apparent diffusion coefficient for differentiating early-stage endometrial carcinomas from benign mimickers at 3T MRI.

PubMed

Wang, Xue; Zhao, Yu; Hu, Yumin; Zhou, Yongjin; Ye, Xinjian; Liu, Kun; Bai, Guanghui; Guo, Anna; Du, Meimei; Jiang, Lezhen; Wang, Jinhong; Yan, Zhihan

2017-07-11

Previous researchers obtained various apparent diffusion coefficient (ADC) cutoff values to differentiate endometrial carcinoma from benign mimickers with 1.5T magnetic resonance imaging (MRI). Few studies have used 3T MRI or validated the effectiveness of these cutoff ADC values prospectively. This study was designed in two stages to obtain a cutoff ADC value at 3T MRI and to validate prospectively the role of the ADC value. First, we conducted a retrospective study of 60 patients to evaluate the diagnostic value of ADC by obtain a theoretical cutoff ADC value for differentiating between benign and malignant endometrial lesions. Student's t test revealed that ADC values for stage I endometrial carcinomas were significantly lower than those for benign lesions. The area under the curve value of the receiver operating characteristic curve was 0.993, and the cutoff ADC value was 0.98 × 10-3 mm2/s. The sensitivity, specificity, and overall accuracy of diagnosing stage I endometrial carcinoma were 100%, 97.1%, and 98.3%, respectively. Second, we conducted a prospective study of 26 patients to validate the use of the cutoff ADC value obtained in the study's first stage. The sensitivity, specificity, and overall accuracy for differentiating malignant from benign endometrial lesions based on the cutoff ADC value obtained earlier were as follows: radiologist 1 attained 86.67%, 100.0%, and 92.31%, respectively; radiologist 2 attained 86.67%, 91.0%, and 88.5%, respectively. Our results suggest that ADC values could be a potential biomarker for use as a quantitative and qualitative tool for differentiating between early-stage endometrial carcinomas and benign mimickers.

Evaluation and validation of the diagnostic value of the apparent diffusion coefficient for differentiating early-stage endometrial carcinomas from benign mimickers at 3T MRI

PubMed Central

Hu, Yumin; Zhou, Yongjin; Ye, Xinjian; Liu, Kun; Bai, Guanghui; Guo, Anna; Du, Meimei; Jiang, Lezhen

2017-01-01

Previous researchers obtained various apparent diffusion coefficient (ADC) cutoff values to differentiate endometrial carcinoma from benign mimickers with 1.5T magnetic resonance imaging (MRI). Few studies have used 3T MRI or validated the effectiveness of these cutoff ADC values prospectively. This study was designed in two stages to obtain a cutoff ADC value at 3T MRI and to validate prospectively the role of the ADC value. First, we conducted a retrospective study of 60 patients to evaluate the diagnostic value of ADC by obtain a theoretical cutoff ADC value for differentiating between benign and malignant endometrial lesions. Student's t test revealed that ADC values for stage I endometrial carcinomas were significantly lower than those for benign lesions. The area under the curve value of the receiver operating characteristic curve was 0.993, and the cutoff ADC value was 0.98 × 10−3 mm2/s. The sensitivity, specificity, and overall accuracy of diagnosing stage I endometrial carcinoma were 100%, 97.1%, and 98.3%, respectively. Second, we conducted a prospective study of 26 patients to validate the use of the cutoff ADC value obtained in the study's first stage. The sensitivity, specificity, and overall accuracy for differentiating malignant from benign endometrial lesions based on the cutoff ADC value obtained earlier were as follows: radiologist 1 attained 86.67%, 100.0%, and 92.31%, respectively; radiologist 2 attained 86.67%, 91.0%, and 88.5%, respectively. Our results suggest that ADC values could be a potential biomarker for use as a quantitative and qualitative tool for differentiating between early-stage endometrial carcinomas and benign mimickers. PMID:28634318

The Measurement of Executive Function at Age 3 Years: Psychometric Properties and Criterion Validity of a New Battery of Tasks

ERIC Educational Resources Information Center

Willoughby, Michael T.; Blair, Clancy B.; Wirth, R. J.; Greenberg, Mark

2010-01-01

In this study, the authors examined the psychometric properties and criterion validity of a newly developed battery of tasks that were designed to assess executive function (EF) abilities in early childhood. The battery was included in the 36-month assessment of the Family Life Project (FLP), a prospective longitudinal study of 1,292 children…

Prospective validation of pathologic complete response models in rectal cancer: Transferability and reproducibility.

PubMed

van Soest, Johan; Meldolesi, Elisa; van Stiphout, Ruud; Gatta, Roberto; Damiani, Andrea; Valentini, Vincenzo; Lambin, Philippe; Dekker, Andre

2017-09-01

Multiple models have been developed to predict pathologic complete response (pCR) in locally advanced rectal cancer patients. Unfortunately, validation of these models normally omit the implications of cohort differences on prediction model performance. In this work, we will perform a prospective validation of three pCR models, including information whether this validation will target transferability or reproducibility (cohort differences) of the given models. We applied a novel methodology, the cohort differences model, to predict whether a patient belongs to the training or to the validation cohort. If the cohort differences model performs well, it would suggest a large difference in cohort characteristics meaning we would validate the transferability of the model rather than reproducibility. We tested our method in a prospective validation of three existing models for pCR prediction in 154 patients. Our results showed a large difference between training and validation cohort for one of the three tested models [Area under the Receiver Operating Curve (AUC) cohort differences model: 0.85], signaling the validation leans towards transferability. Two out of three models had a lower AUC for validation (0.66 and 0.58), one model showed a higher AUC in the validation cohort (0.70). We have successfully applied a new methodology in the validation of three prediction models, which allows us to indicate if a validation targeted transferability (large differences between training/validation cohort) or reproducibility (small cohort differences). © 2017 American Association of Physicists in Medicine.

Impact of positive and negative lesion site remodeling on clinical outcomes: insights from PROSPECT.

PubMed

Inaba, Shinji; Mintz, Gary S; Farhat, Naim Z; Fajadet, Jean; Dudek, Dariusz; Marzocchi, Antonio; Templin, Barry; Weisz, Giora; Xu, Ke; de Bruyne, Bernard; Serruys, Patrick W; Stone, Gregg W; Maehara, Akiko

2014-01-01

This study investigated coronary artery remodeling patterns associated with clinical outcomes. In the prospective, multicenter PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree: An Imaging Study in Patients With Unstable Atherosclerotic Lesions) study, reported predictors of nonculprit lesion (NCL) major adverse cardiac events (MACE) were an intravascular ultrasound (IVUS) minimal lumen area (MLA) ≤4 mm(2), a plaque burden ≥70%, and a IVUS-virtual histology (VH) thin-cap fibroatheroma (TCFA), but not lesion site remodeling. Overall, 697 consecutive patients with an acute coronary syndrome were enrolled and underwent 3-vessel gray-scale and IVUS-VH; 3,223 NCLs were identified by IVUS. The remodeling index (RI) was calculated as the external elastic membrane area at the MLA site divided by the average of the proximal and distal reference external elastic membrane areas. First, one third of the patients were randomly selected to determine RI cutoffs related to NCL MACE (development cohort). Receiver-operating characteristic analysis showed that there were 2 separate cut points that predicted NCL MACE: RI = 0.8789 and RI = 1.0046 (area under the curve = 0.663). These cut points were used to define negative remodeling as an RI <0.88, intermediate remodeling as an RI of 0.88 to 1.00, and positive remodeling as an RI >1.00. Second, we used the remaining two-thirds of patients to validate these cut points with respect to lesion morphology and clinical outcomes (validation cohort). Kaplan-Meier curve analysis in the validation cohort showed that NCL MACE occurred more frequent (and equally) in negative and positive remodeling lesions compared with intermediate remodeling lesions. In this cohort, negative remodeling lesions had the smallest MLA, positive remodeling lesions had the largest plaque burden, and VH TCFA, especially VH TCFA with multiple necrotic cores, was most common in negatively remodeling lesions. The present study showed the novel concept that positive and negative lesion site remodeling was associated with unanticipated NCL MACE in the PROSPECT study. ( An Imaging Study in Patients With Unstable Atherosclerotic Lesions [PROSPECT]; NCT00180466). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

P21, COX-2, and E-cadherin are potential prognostic factors for esophageal squamous cell carcinoma.

PubMed

Lin, Yao; Shen, Lu-Yan; Fu, Hao; Dong, Bin; Yang, He-Li; Yan, Wan-Pu; Kang, Xiao-Zheng; Dai, Liang; Zhou, Hai-Tao; Yang, Yong-Bo; Liang, Zhen; Chen, Ke-Neng

2017-02-01

Much research effort has been devoted to identifying prognostic factors for esophageal squamous cell carcinoma (ESCC) by immunohistochemistry; however, no conclusive findings have been reached thus far. We hypothesized that certain molecules identified in previous studies might serve as useful prognostic markers for ESCC. Therefore, the aim of the current study was to validate the most relevant markers showing potential for ESCC prognosis in our prospective esophageal cancer database. A literature search was performed using the PubMed database for papers published between 1980 and 2015 using the following key words: 'esophageal cancer,' 'prognosis,' and 'immunohistochemistry.' Literature selection criteria were established to identify the most widely studied markers, and we further validated the selected markers in a cohort from our single-surgeon team, including 153 esophageal cancer patients treated from 2000 to 2010. A total of 1799 articles were identified, 82 of which met the selection criteria. Twelve markers were found to be the most widely studied, and the validation results indicated that only P21, COX-2, and E-cadherin were independent prognostic factors for ESCC patients in this series. The systemic review and cohort validation suggest that P21, COX-2, and E-cadherin are potential prognostic factors for ESCC, paving the way for more targeted prospective validation in the future. © 2016 International Society for Diseases of the Esophagus.

Morbidity and mortality of complex spine surgery: a prospective cohort study in 679 patients validating the Spine AdVerse Event Severity (SAVES) system in a European population.

PubMed

Karstensen, Sven; Bari, Tanvir; Gehrchen, Martin; Street, John; Dahl, Benny

2016-02-01

Most literature on complications in spine surgery has been retrospective or based on national databases with few variables. The Spine AdVerse Events Severity (SAVES) system has been found reliable and valid in two Canadian centers, providing precise information regarding all adverse events (AEs). This study aimed to determine the mortality and examine the incidence of morbidity in patients undergoing complex spinal surgery, including pediatric patients, and to validate the SAVES system in a European population. A prospective, consecutive cohort study was conducted using the SAVES version 2010 in the period from January 1, 2013 until December 31, 2013. A retrospective analysis was performed on all patients operated from November 1, 2011 until October 31, 2012 for comparison. Patients undergoing spinal surgery at a tertiary referral center comprised the patient sample. Morbidity and mortality were determined according to the newest version of the SAVES system and compared with the Canadian cohort. Other outcomes were length of stay, readmission, unplanned second surgery during index admission, as well as wound infections requiring revision. All patients undergoing spinal surgery at an academic tertiary referral center in the study period were prospectively included. The newest version of SAVES system was used, and a research coordinator collected all intraoperative and perioperative data prospectively. Once a week all patients were reviewed for additional events, validation of the data, and clarification of any questions. Patients were grouped according to the type of admission (elective of emergency) and age, and subgrouped according to a major diagnostic group. The survival status was registered on January 31, 2014 to obtain 30-day survival. A total of 679 consecutive cases were included with 100% data completion. The in-hospital mortality was 1.3% and the 30-day mortality was 2.7%; all occurring after emergency procedures. The number of intraoperative AEs was 162 (overall incidence 20%), and the number of postoperative AEs was 1,415 (overall incidence 77%). Of the patients, 2.2% had postoperative infections requiring surgical revision. A prospective registration improves AE recognition, and our data confirm the generalizability of the SAVES system to pediatric and non-Canadian populations. Copyright © 2015 Elsevier Inc. All rights reserved.

Multimodal Navigation in Endoscopic Transsphenoidal Resection of Pituitary Tumors Using Image-Based Vascular and Cranial Nerve Segmentation: A Prospective Validation Study.

PubMed

Dolati, Parviz; Eichberg, Daniel; Golby, Alexandra; Zamani, Amir; Laws, Edward

2016-11-01

Transsphenoidal surgery (TSS) is the most common approach for the treatment of pituitary tumors. However, misdirection, vascular damage, intraoperative cerebrospinal fluid leakage, and optic nerve injuries are all well-known complications, and the risk of adverse events is more likely in less-experienced hands. This prospective study was conducted to validate the accuracy of image-based segmentation coupled with neuronavigation in localizing neurovascular structures during TSS. Twenty-five patients with a pituitary tumor underwent preoperative 3-T magnetic resonance imaging (MRI), and MRI images loaded into the navigation platform were used for segmentation and preoperative planning. After patient registration and subsequent surgical exposure, each segmented neural or vascular element was validated by manual placement of the navigation probe or Doppler probe on or as close as possible to the target. Preoperative segmentation of the internal carotid artery and cavernous sinus matched with the intraoperative endoscopic and micro-Doppler findings in all cases. Excellent correspondence between image-based segmentation and the endoscopic view was also evident at the surface of the tumor and at the tumor-normal gland interfaces. Image guidance assisted the surgeons in localizing the optic nerve and chiasm in 64% of cases. The mean accuracy of the measurements was 1.20 ± 0.21 mm. Image-based preoperative vascular and neural element segmentation, especially with 3-dimensional reconstruction, is highly informative preoperatively and potentially could assist less-experienced neurosurgeons in preventing vascular and neural injury during TSS. In addition, the accuracy found in this study is comparable to previously reported neuronavigation measurements. This preliminary study is encouraging for future prospective intraoperative validation with larger numbers of patients. Copyright © 2016 Elsevier Inc. All rights reserved.

The development and validation of the Self-Efficacy Beliefs about Equitable Science Teaching and learning instrument for prospective elementary teachers

NASA Astrophysics Data System (ADS)

Ritter, Jennifer M.

1999-12-01

The purpose of this study was to develop, validate and establish the reliability of an instrument to assess the self-efficacy beliefs of prospective elementary teachers with regards to science teaching and learning for diverse learners. The study used Bandura's theoretical framework, in that the instrument would use the self-efficacy construct to explore the beliefs of prospective elementary science teachers with regards to science teaching and learning to diverse learners: specifically the two dimensions of self-efficacy beliefs defined by Bandura (1977): personal self-efficacy and outcome expectancy. A seven step plan was designed and followed in the process of developing the instrument, which was titled the Self-Efficacy Beliefs about Equitable Science Teaching or SEBEST. Diverse learners as recognized by Science for All Americans (1989) are "those who in the past who have largely been bypassed in science and mathematics education: ethnic and language minorities and girls" (p. xviii). That definition was extended by this researcher to include children from low socioeconomic backgrounds based on the research by Gomez and Tabachnick (1992). The SEBEST was administered to 226 prospective elementary teachers at The Pennsylvania State University. Using the results from factor analyses, Coefficient Alpha, and Chi-Square a 34 item instrument was found to achieve the greatest balance across the construct validity, reliability and item balance with the content matrix. The 34 item SEBEST was found to load purely on four factors across the content matrix thus providing evidence construct validity. The Coefficient Alpha reliability for the 34 item SEBEST was .90 and .82 for the PSE sub-scale and .78 for the OE sub-scale. A Chi-Square test (X2 = 2.7 1, df = 7, p > .05) was used to confirm that the 34 items were balanced across the Personal Self-Efficacy/Outcome Expectancy and Ethnicity/LanguageMinority/Gender Socioeconomic Status/dimensions of the content matrix. Based on the standardized development procedures used and the associated evidence, the SEBEST appears to be a content and construct valid instrument, with high internal reliability and moderate test-retest reliability qualities, for use with prospective elementary teachers to assess self-efficacy beliefs for teaching and learning science for diverse learners.

An analysis of retrospective and repeat prospective reports of adverse childhood experiences from the South African Birth to Twenty Plus cohort

PubMed Central

Norris, Shane A.; Mabaso, Musawenkosi; Richter, Linda M.

2017-01-01

Most studies rely on cross-sectional retrospective reports from adult samples to collect information about adverse childhood experiences (ACEs) to examine relationships with adult outcomes. The problems associated with these reports have long been debated, with only a few studies determining their reliability and validity and fewer still reaching consensus on the matter. This paper uses repeat prospective and retrospective reports of adverse childhood experiences from two respondent sources in the South African Birth to Twenty Plus (Bt20+) cohort to explore agreement and concordance in the prospective reporting of ACEs by caregivers and respective children as adolescents and then as young adults. The findings demonstrate little overall agreement between prospective and retrospective accounts of childhood experiences, with 80% of kappa values below the moderate agreement cutoff (k = .41). The highest levels of agreement were found between prospective and retrospective reporting on parental and household death (kappas ranging from .519 to .944). Comparisons between prospective caregiver reports and retrospective young adult reports yielded high concordance rates on sexual and physical abuse and exposure to intimate partner violence (91.0%, 87.7% and 80.2%, respectively). The prevalence of reported ACEs varied with the age of the respondent, with adolescents reporting much higher rates of exposure to violence, physical and sexual abuse than are reported retrospectively or by caregivers. This variation may partly reflect actual changes in circumstances with maturation, but may be influenced by developmental stage and issues of memory, cognition and emotional state more than has been considered in previous analyses. More research, across disciplines, is needed to understand these processes and their effect on recall. Long-term prospective studies are critical for this purpose. In conclusion, methodological research that uses a range of information sources to establish the reliability and validity of both retrospective and prospective reports ‒ recognizing that the two approaches may fundamentally answer different questions ‒ should be encouraged. PMID:28746343

The Effect of Using Writer's Workshop Approach on Developing Basic Writing Skills (Mechanics of Writing) of Prospective Teachers of English in Egypt

ERIC Educational Resources Information Center

Salem, Ashraf Atta M. S.

2013-01-01

The present study aimed at investigating the effects of using a program based on the writing workshop approach on developing basic writing skills of prospective teachers of English in Hurgada faculty of Education. For that purpose, the researcher constructed and validated a teaching program based on the writing workshop approach, checklist of the…

Study Protocol, Sample Characteristics, and Loss to Follow-Up: The OPPERA Prospective Cohort Study

PubMed Central

Bair, Eric; Brownstein, Naomi C.; Ohrbach, Richard; Greenspan, Joel D.; Dubner, Ron; Fillingim, Roger B.; Maixner, William; Smith, Shad; Diatchenko, Luda; Gonzalez, Yoly; Gordon, Sharon; Lim, Pei-Feng; Ribeiro-Dasilva, Margarete; Dampier, Dawn; Knott, Charles; Slade, Gary D.

2013-01-01

When studying incidence of pain conditions such as temporomandibular disorders (TMDs), repeated monitoring is needed in prospective cohort studies. However, monitoring methods usually have limitations and, over a period of years, some loss to follow-up is inevitable. The OPPERA prospective cohort study of first-onset TMD screened for symptoms using quarterly questionnaires and examined symptomatic participants to definitively ascertain TMD incidence. During the median 2.8-year observation period, 16% of the 3,263 enrollees completed no follow-up questionnaires, others provided incomplete follow-up, and examinations were not conducted for one third of symptomatic episodes. Although screening methods and examinations were found to have excellent reliability and validity, they were not perfect. Loss to follow-up varied according to some putative TMD risk factors, although multiple imputation to correct the problem suggested that bias was minimal. A second method of multiple imputation that evaluated bias associated with omitted and dubious examinations revealed a slight underestimate of incidence and some small biases in hazard ratios used to quantify effects of risk factors. Although “bottom line” statistical conclusions were not affected, multiply-imputed estimates should be considered when evaluating the large number of risk factors under investigation in the OPPERA study. Perspective These findings support the validity of the OPPERA prospective cohort study for the purpose of investigating the etiology of first-onset TMD, providing the foundation for other papers investigating risk factors hypothesized in the OPPERA project. PMID:24275220

Standardized assessment of psychosocial factors and their influence on medically confirmed health outcomes in workers: a systematic review.

PubMed

Rosário, Susel; Fonseca, João A; Nienhaus, Albert; da Costa, José Torres

2016-01-01

Previous studies of psychosocial work factors have indicated their importance for workers' health. However, to what extent health problems can be attributed to the nature of the work environment or other psychosocial factors is not clear. No previous systematic review has used inclusion criteria based on specific medical evaluation of work-related health outcomes and the use of validated instruments for the assessment of the psychosocial (work) environment. The aim of this systematic review is to summarize the evidence assessing the relationship between the psychosocial work environment and workers' health based on studies that used standardized and validated instruments to assess the psychosocial work environment and that focused on medically confirmed health outcomes. A systematic review of the literature was carried out by searching the databases PubMed, B-ON, Science Direct, Psycarticles, Psychology and Behavioral Sciences Collection and the search engine (Google Scholar) using appropriate words for studies published from 2004 to 2014. This review follows the recommendations of the Statement for Reporting Systematic Reviews (PRISMA). Studies were included in the review if data on psychosocial validated assessment method(s) for the study population and specific medical evaluation of health-related work outcome(s) were presented. In total, the search strategy yielded 10,623 references, of which 10 studies (seven prospective cohort and three cross-sectional) met the inclusion criteria. Most studies (7/10) observed an adverse effect of poor psychosocial work factors on workers' health: 3 on sickness absence, 4 on cardiovascular diseases. The other 3 studies reported detrimental effects on sleep and on disease-associated biomarkers. A more consistent effect was observed in studies of higher methodological quality that used a prospective design jointly with the use of validated instruments for the assessment of the psychosocial (work) environment and clinical evaluation. More prospective studies are needed to assess the evidence of work-related psychosocial factors on workers´ health.

RON is not a prognostic marker for resectable pancreatic cancer.

PubMed

Tactacan, Carole M; Chang, David K; Cowley, Mark J; Humphrey, Emily S; Wu, Jianmin; Gill, Anthony J; Chou, Angela; Nones, Katia; Grimmond, Sean M; Sutherland, Robert L; Biankin, Andrew V; Daly, Roger J

2012-09-07

The receptor tyrosine kinase RON exhibits increased expression during pancreatic cancer progression and promotes migration, invasion and gemcitabine resistance of pancreatic cancer cells in experimental models. However, the prognostic significance of RON expression in pancreatic cancer is unknown. RON expression was characterized in several large cohorts, including a prospective study, totaling 492 pancreatic cancer patients and relationships with patient outcome and clinico-pathologic variables were assessed. RON expression was associated with outcome in a training set, but this was not recapitulated in the validation set, nor was there any association with therapeutic responsiveness in the validation set or the prospective study. Although RON is implicated in pancreatic cancer progression in experimental models, and may constitute a therapeutic target, RON expression is not associated with prognosis or therapeutic responsiveness in resected pancreatic cancer.

Prospective validation of immunological infiltrate for prediction of response to neoadjuvant chemotherapy in HER2-negative breast cancer--a substudy of the neoadjuvant GeparQuinto trial.

PubMed

Issa-Nummer, Yasmin; Darb-Esfahani, Silvia; Loibl, Sibylle; Kunz, Georg; Nekljudova, Valentina; Schrader, Iris; Sinn, Bruno Valentin; Ulmer, Hans-Ullrich; Kronenwett, Ralf; Just, Marianne; Kühn, Thorsten; Diebold, Kurt; Untch, Michael; Holms, Frank; Blohmer, Jens-Uwe; Habeck, Jörg-Olaf; Dietel, Manfred; Overkamp, Friedrich; Krabisch, Petra; von Minckwitz, Gunter; Denkert, Carsten

2013-01-01

We have recently described an increased lymphocytic infiltration rate in breast carcinoma tissue is a significant response predictor for anthracycline/taxane-based neoadjuvant chemotherapy (NACT). The aim of this study was to prospectively validate the tumor-associated lymphocyte infiltrate as predictive marker for response to anthracycline/taxane-based NACT. The immunological infiltrate was prospectively evaluated in a total of 313 core biopsies from HER2 negative patients of the multicenter PREDICT study, a substudy of the neoadjuvant GeparQuinto study. Intratumoral lymphocytes (iTuLy), stromal lymphocytes (strLy) as well as lymphocyte-predominant breast cancer (LPBC) were evaluated by histopathological assessment. Pathological complete response (pCR) rates were analyzed and compared between the defined subgroups using the exact test of Fisher. Patients with lymphocyte-predominant breast cancer (LPBC) had a significantly increased pCR rate of 36.6%, compared to non-LPBC patients (14.3%, p<0.001). LPBC and stromal lymphocytes were significantly independent predictors for pCR in multivariate analysis (LPBC: OR 2.7, p = 0.003, strLy: OR 1.2, p = 0.01). The amount of intratumoral lymphocytes was significantly predictive for pCR in univariate (OR 1.2, p = 0.01) but not in multivariate logistic regression analysis (OR 1.2, p = 0.11). Confirming previous investigations of our group, we have prospectively validated in an independent cohort that an increased immunological infiltrate in breast tumor tissue is predictive for response to anthracycline/taxane-based NACT. Patients with LPBC and increased stromal lymphocyte infiltration have significantly increased pCR rates. The lymphocytic infiltrate is a promising additional parameter for histopathological evaluation of breast cancer core biopsies.

Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis.

PubMed

Moojen, Wouter A; Arts, Mark P; Bartels, Ronald H M A; Jacobs, Wilco C H; Peul, Wilco C

2011-10-01

Despite an increasing implantation rate of interspinous process distraction (IPD) devices in the treatment of intermittent neurogenic claudication (INC), definitive evidence on the clinical effectiveness of implants is lacking. The main objective of this review was to perform a meta-analysis of all systematic reviews, randomized clinical trials and prospective cohort series to quantify the effectiveness of IPDs and to evaluate the potential side-effects. Data from all studies prospectively describing clinical results based on validated outcome scales and reporting complications of treatment of patients with INC with IPD placement. We searched MEDLINE, EMBASE, Web of Science, Cochrane (CENTRAL), CINAHL, Academic Search Premier, Science Direct up to July 2010. Studies describing patients with INC caused by lumbar stenosis, reporting complication rate and reporting based on validated outcome scores, were eligible. Studies with only instrumented IPD results were excluded. Eleven studies eligible studies were identified. Two independently RCTs and eight prospective cohorts were available. In total 563 patients were treated with IPDs. All studies showed improvement in validated outcome scores after 6 weeks and 1 year. Pooled data based on the Zurich Claudication Questionnaire of the RCTs were more in favor of IPD treatment compared with conservative treatment (pooled estimate 23.2, SD 18.5-27.8). Statistical heterogeneity after pooled data was low (I-squared 0.0, p = 0.930). Overall complication rate was 7%. As the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced.

A multicenter prospective cohort study on camera navigation training for key user groups in minimally invasive surgery.

PubMed

Graafland, Maurits; Bok, Kiki; Schreuder, Henk W R; Schijven, Marlies P

2014-06-01

Untrained laparoscopic camera assistants in minimally invasive surgery (MIS) may cause suboptimal view of the operating field, thereby increasing risk for errors. Camera navigation is often performed by the least experienced member of the operating team, such as inexperienced surgical residents, operating room nurses, and medical students. The operating room nurses and medical students are currently not included as key user groups in structured laparoscopic training programs. A new virtual reality laparoscopic camera navigation (LCN) module was specifically developed for these key user groups. This multicenter prospective cohort study assesses face validity and construct validity of the LCN module on the Simendo virtual reality simulator. Face validity was assessed through a questionnaire on resemblance to reality and perceived usability of the instrument among experts and trainees. Construct validity was assessed by comparing scores of groups with different levels of experience on outcome parameters of speed and movement proficiency. The results obtained show uniform and positive evaluation of the LCN module among expert users and trainees, signifying face validity. Experts and intermediate experience groups performed significantly better in task time and camera stability during three repetitions, compared to the less experienced user groups (P < .007). Comparison of learning curves showed significant improvement of proficiency in time and camera stability for all groups during three repetitions (P < .007). The results of this study show face validity and construct validity of the LCN module. The module is suitable for use in training curricula for operating room nurses and novice surgical trainees, aimed at improving team performance in minimally invasive surgery. © The Author(s) 2013.

Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

DTIC Science & Technology

2017-10-01

been shown in many studies to improve predictive accuracy for cancer on initial biopsy,3,7-9 and to be correlated with more aggressive cancer at...our multi-center, prospectively accrued prostate cancer active surveillance cohort – the Canary Prostate Active Surveillance Study (PASS). We are in...objective of the study is to utilize analytically validated assays that take into account tumor heterogeneity to measure biomarkers in specimens that were

Comparing the usefulness of the 1997 and 2009 WHO dengue case classification: a systematic literature review.

PubMed

Horstick, Olaf; Jaenisch, Thomas; Martinez, Eric; Kroeger, Axel; See, Lucy Lum Chai; Farrar, Jeremy; Ranzinger, Silvia Runge

2014-09-01

The 1997 and 2009 WHO dengue case classifications were compared in a systematic review with 12 eligible studies (4 prospective). Ten expert opinion articles were used for discussion. For the 2009 WHO classification studies show: when determining severe dengue sensitivity ranges between 59-98% (88%/98%: prospective studies), specificity between 41-99% (99%: prospective study) - comparing the 1997 WHO classification: sensitivity 24.8-89.9% (24.8%/74%: prospective studies), specificity: 25%/100% (100%: prospective study). The application of the 2009 WHO classification is easy, however for (non-severe) dengue there may be a risk of monitoring increased case numbers. Warning signs validation studies are needed. For epidemiological/pathogenesis research use of the 2009 WHO classification, opinion papers show that ease of application, increased sensitivity (severe dengue) and international comparability are advantageous; 3 severe dengue criteria (severe plasma leakage, severe bleeding, severe organ manifestation) are useful research endpoints. The 2009 WHO classification has clear advantages for clinical use, use in epidemiology is promising and research use may at least not be a disadvantage. © The American Society of Tropical Medicine and Hygiene.

Brief Assessment of Motor Function: Content Validity and Reliability of the Upper Extremity Gross Motor Scale

ERIC Educational Resources Information Center

Cintas, Holly Lea; Parks, Rebecca; Don, Sarah; Gerber, Lynn

2011-01-01

Content validity and reliability of the Brief Assessment of Motor Function (BAMF) Upper Extremity Gross Motor Scale (UEGMS) were evaluated in this prospective, descriptive study. The UEGMS is one of five BAMF ordinal scales designed for quick documentation of gross, fine, and oral motor skill levels. Designed to be independent of age and…

Transcultural adaptation and validation of the patient empowerment in long-term conditions questionnaire.

PubMed

Garcimartin, Paloma; Comin-Colet, Josep; Delgado-Hito, Pilar; Badosa-Marcé, Neus; Linas-Alonso, Anna

2017-05-04

Patient empowerment is a key element to improve the results in health, increase satisfaction amongst users and obtain higher treatment compliance. The main objective of this study is to validate the Spanish version of the questionnaire "Patient empowerment in long-term conditions" which evaluates the patients' level of empowerment of chronic diseases. The secondary objective is to identify factors which predict basal empowerment and changes (improvement or deterioration) in patients with Heart Failure (HF). An observational and prospective design of psychometric type to validate a questionnaire (aim 1) and a prospective study of cohorts (aim 2). The study will include 121 patients with confirmed diagnosis of HF. Three measurements (basal, at 15 days and at 3 months) will be carried out: quality of life, self-care and empowerment. Descriptive and inferential analyses will be used. For the first aim of the study (validation), the test-retest reproducibility will be assessed through intraclass correlation coefficient; internal consistency will be assessed through Cronbach's alpha coefficient; construct validity through Pearson's correlation coefficient; and sensibility to change through effect size coefficient. Set a valid questionnaire to measure the level of empowerment of patients with chronic diseases could be an effective tool to assess the results from the provision of the health care services. It will also allow us to identify at an early stage, those groups of patients with a low level of empowerment. Hence, they could become a risk group due to poor management of the disease, with a high rate of decompensation and a higher use rate of the health system resources.

The Potential Utility of Urinary Biomarkers for Risk Prediction in Combat Casualties: A Prospective Observational Cohort Study

DTIC Science & Technology

2015-06-16

are associated with poor outcomes, including death and the need for renal replacement therapy. Methods : We conducted a prospective, observational study...penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 16 JUN 2015...2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE The Potential Utility of Urinary Biomarkers for Risk Prediction in Combat

Pre- and post-drill comparison of the Mount Elbert gas hydrate prospect, Alaska North Slope

USGS Publications Warehouse

Lee, M.W.; Agena, W.F.; Collett, T.S.; Inks, T.L.

2011-01-01

In 2006, the United States Geological Survey (USGS) completed a detailed analysis and interpretation of available 2-D and 3-D seismic data, along with seismic modeling and correlation with specially processed downhole well log data for identifying potential gas hydrate accumulations on the North Slope of Alaska. A methodology was developed for identifying sub-permafrost gas hydrate prospects within the gas hydrate stability zone in the Milne Point area. The study revealed a total of 14 gas hydrate prospects in this area.In order to validate the gas hydrate prospecting protocol of the USGS and to acquire critical reservoir data needed to develop a longer-term production testing program, a stratigraphic test well was drilled at the Mount Elbert prospect in the Milne Point area in early 2007. The drilling confirmed the presence of two prominent gas-hydrate-bearing units in the Mount Elbert prospect, and high quality well logs and core data were acquired. The post-drill results indicate pre-drill predictions of the reservoir thickness and the gas-hydrate saturations based on seismic and existing well data were 90% accurate for the upper unit (hydrate unit D) and 70% accurate for the lower unit (hydrate unit C), confirming the validity of the USGS approach to gas hydrate prospecting. The Mount Elbert prospect is the first gas hydrate accumulation on the North Slope of Alaska identified primarily on the basis of seismic attribute analysis and specially processed downhole log data. Post-drill well log data enabled a better constraint of the elastic model and the development of an improved approach to the gas hydrate prospecting using seismic attributes. ?? 2009.

Selective testing strategies for diagnosing group A streptococcal infection in children with pharyngitis: a systematic review and prospective multicentre external validation study

PubMed Central

Cohen, Jérémie F.; Cohen, Robert; Levy, Corinne; Thollot, Franck; Benani, Mohamed; Bidet, Philippe; Chalumeau, Martin

2015-01-01

Background: Several clinical prediction rules for diagnosing group A streptococcal infection in children with pharyngitis are available. We aimed to compare the diagnostic accuracy of rules-based selective testing strategies in a prospective cohort of children with pharyngitis. Methods: We identified clinical prediction rules through a systematic search of MEDLINE and Embase (1975–2014), which we then validated in a prospective cohort involving French children who presented with pharyngitis during a 1-year period (2010–2011). We diagnosed infection with group A streptococcus using two throat swabs: one obtained for a rapid antigen detection test (StreptAtest, Dectrapharm) and one obtained for culture (reference standard). We validated rules-based selective testing strategies as follows: low risk of group A streptococcal infection, no further testing or antibiotic therapy needed; intermediate risk of infection, rapid antigen detection for all patients and antibiotic therapy for those with a positive test result; and high risk of infection, empiric antibiotic treatment. Results: We identified 8 clinical prediction rules, 6 of which could be prospectively validated. Sensitivity and specificity of rules-based selective testing strategies ranged from 66% (95% confidence interval [CI] 61–72) to 94% (95% CI 92–97) and from 40% (95% CI 35–45) to 88% (95% CI 85–91), respectively. Use of rapid antigen detection testing following the clinical prediction rule ranged from 24% (95% CI 21–27) to 86% (95% CI 84–89). None of the rules-based selective testing strategies achieved our diagnostic accuracy target (sensitivity and specificity > 85%). Interpretation: Rules-based selective testing strategies did not show sufficient diagnostic accuracy in this study population. The relevance of clinical prediction rules for determining which children with pharyngitis should undergo a rapid antigen detection test remains questionable. PMID:25487666

Quality control of colonoscopy procedures: a prospective validated method for the evaluation of professional practices applicable to all endoscopic units.

PubMed

Coriat, R; Pommaret, E; Chryssostalis, A; Viennot, S; Gaudric, M; Brezault, C; Lamarque, D; Roche, H; Verdier, D; Parlier, D; Prat, F; Chaussade, S

2009-02-01

To produce valid information, an evaluation of professional practices has to assess the quality of all practices before, during and after the procedure under study. Several auditing techniques have been proposed for colonoscopy. The purpose of this work is to describe a straightforward original validated method for the prospective evaluation of professional practices in the field of colonoscopy applicable in all endoscopy units without increasing the staff work load. Pertinent quality-control criteria (14 items) were identified by the endoscopists at the Cochin Hospital and were compatible with: findings in the available literature; guidelines proposed by the Superior Health Authority; and application in any endoscopy unit. Prospective routine data were collected and the methodology validated by evaluating 50 colonoscopies every quarter for one year. The relevance of the criteria was assessed using data collected during four separate periods. The standard checklist was complete for 57% of the colonoscopy procedures. The colonoscopy procedure was appropriate according to national guidelines in 94% of cases. These observations were particularly noteworthy: the quality of the colonic preparation was insufficient for 9% of the procedures; complete colonoscopy was achieved for 93% of patients; and 0.38 adenomas and 0.045 carcinomas were identified per colonoscopy. This simple and reproducible method can be used for valid quality-control audits in all endoscopy units. In France, unit-wide application of this method enables endoscopists to validate 100 of the 250 points required for continuous medical training. This is a quality-control tool that can be applied annually, using a random month to evaluate any changes in routine practices.

Risk factors of Internet addiction and the health effect of internet addiction on adolescents: a systematic review of longitudinal and prospective studies.

PubMed

Lam, Lawrence T

2014-11-01

Internet gaming addiction was included in the latest version of the DSM-V as a possible disorder recently, while debate is still on-going as to whether the condition called "Internet Addiction" (IA) could be fully recognised as an established disorder. The major contention is how well IA could fulfil the validation criteria as a psychiatric disorder as in other well-established behavioural addictions. In addition to various proposed validation criteria, evidence of risk and protective factors as well as development of outcomes from longitudinal and prospective studies are suggested as important. A systematic review of available longitudinal and prospective studies was conducted to gather epidemiological evidence on risk and protective factors of IA and the health effect of IA on adolescents. Nine articles were identified after an extensive search of the literature in accordance to the PRISMA guidelines. Of these, eight provided data on risk or protective factors of IA and one focused solely on the effects of IA on mental health. Information was extracted and analysed systematically from each study and tabulated. Many exposure variables were studied and could be broadly classified into three main categories: psychopathologies of the participants, family and parenting factors, and others such as Internet usage, motivation, and academic performance. Some were found to be potential risk or protective factors of IA. It was also found that exposure to IA had a detrimental effect on the mental health of young people. These results were discussed in light of their implications to the fulfilment of the validation criteria.

A prospective validation of the Bova score in normotensive patients with acute pulmonary embolism.

PubMed

Bova, Carlo; Vanni, Simone; Prandoni, Paolo; Morello, Fulvio; Dentali, Francesco; Bernardi, Enrico; Mumoli, Nicola; Bucherini, Eugenio; Barbar, Sofia; Picariello, Claudio; Enea, Iolanda; Pesavento, Raffaele; Bottino, Fabrizio; Jiménez, David

2018-05-01

The Bova score has shown usefulness in the identification of intermediate-high risk patients with acute pulmonary embolism (PE), but lacks prospective validation. The aim of this study was to prospectively validate the Bova score in different settings from the original derivation cohort. Consecutive, normotensive patients with acute PE recruited at 13 academic or general hospitals were stratified, using their baseline data, into the three Bova risk stages (I-III). The primary outcome was the 30-day composite of PE-related mortality, hemodynamic collapse and non-fatal PE recurrences in the three risk categories. In the study period, 639 patients were enrolled. The primary end point occurred in 45 patients (7.0%; 95% Confidence Intervals, 5.2%-9.3%). Risk stage correlated with the PE-related complication rate (stage I, 2.9%; stage II, 17%; stage III, 27%). Patients classified as stage III by the Bova score had a 6.5-fold increased risk for adverse outcomes (3.1-13.5, p < 0.001) compared with stages I and II combined. Rescue thrombolysis increased from stage I to stage III (0.6%, 12% and 15% respectively). All-cause mortality (5.3%) did not substantially differ among the stages. The Bova score accurately stratifies normotensive patients with acute PE into stages of increasing risk of 30-day PE-related complications. Copyright © 2018 Elsevier Ltd. All rights reserved.

78 FR 71617 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... agencies that have prescription drug programs are required to perform prospective and retrospective drug... study to validate the core competency set among the workforce; (2) establishing the core competency set...

NYU Lung Cancer Biomarker Center — EDRN Public Portal

Cancer.gov

A. SPECIFIC AIMS 1. To develop and prospectively follow a large cohort at high-risk for lung cancer. Individuals are recruited to one of two different study groups: The Screening Cohort includes people with and without increased risk for lung cancer. The Rule-Out Lung Cancer Patient Group is recruited from patients referred for evaluation of suspicious nodules. All individuals answer a questionnaire, obtain PFTs, chest CT scan, sputum induction and phlebotomy. For patients undergoing lung resections or biopsies, tissue samples are collected and banked. Individuals are recruited for research bronchoscopy. All participants are then followed prospectively. The specimens obtained are banked and used for biomarker discovery and validation studies. 2. To identify and validate biomarkers for the early detection of lung cancer, and to describe preneoplastic cellular changes and lesions. Biomarker studies include DNA adducts, DNA methylation, protein markers, and other collaborations. Preneoplasia studies include: fluorescence and Superdimension bronchoscopies to obtain biopsies of preneoplastic lesions and biomarker studies in individuals with preneoplasias.

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

PubMed Central

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

2016-01-01

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

Comparison of ICD-9-based, retrospective, and prospective assessments of perioperative complications: assessment of accuracy in reporting.

PubMed

Campbell, Peter G; Malone, Jennifer; Yadla, Sanjay; Chitale, Rohan; Nasser, Rani; Maltenfort, Mitchell G; Vaccaro, Alex; Ratliff, John K

2011-01-01

large studies of ICD-9-based complication and hospital-acquired condition (HAC) chart reviews have not been validated through a comparison with prospective assessments of perioperative adverse event occurrence. Retrospective chart review, while generally assumed to underreport complication occurrence, has not been subjected to prospective study. It is unclear whether ICD-9-based population studies are more accurate than retrospective reviews or are perhaps equally susceptible to bias. To determine the validity of an ICD-9-based assessment of perioperative complications, the authors compared a prospective independent evaluation of such complications with ICD-9-based HAC data in a cohort of patients who underwent spine surgery. For further comparison, a separate retrospective review of the same cohort of patients was completed as well. a prospective assessment of complications in spine surgery over a 6-month period (May to December 2008) was completed using an independent auditor and a validated definition of perioperative complications. The auditor maintained a prospective database, which included complications occurring in the initial 30 days after surgery. All medical adverse events were included in the assessment. All patients undergoing spine surgery during the study period were eligible for inclusion; the only exclusionary criterion used was the availability of the auditor for patient assessment. From the overall patient database, 100 patients were randomly extracted for further review; in these patients ICD-9-based HAC data were obtained from coder data. Separately, a retrospective assessment of complication incidence was completed using chart and electronic medical record review. The same definition of perioperative adverse events and the inclusion of medical adverse events were applied in the prospective, ICD-9-based, and retrospective assessments. ninety-two patients had adequate records for the ICD-9 assessment, whereas 98 patients had adequate chart information for retrospective review. The overall complication incidence among the groups was similar (major complications: ICD-9 17.4%, retrospective 19.4%, and prospective 22.4%; minor complications: ICD-9 43.8%, retrospective 31.6%, and prospective 42.9%). However, the ICD-9-based assessment included many minor medical events not deemed complications by the auditor. Rates of specific complications were consistently underreported in both the ICD-9 and the retrospective assessments. The ICD-9 assessment underreported infection, the need for reoperation, deep wound infection, deep venous thrombosis, and new neurological deficits (p = 0.003, p < 0.0001, p < 0.0001, p = 0.0025, and p = 0.04, respectively). The retrospective review underestimated incidences of infection, the need for revision, and deep wound infection (p < 0.0001 for each). Only in the capture of new cardiac events was ICD-9-based reporting more accurate than prospective data accrual (p = 0.04). The most sensitive measure for the appreciation of complication occurrence was the prospective review, followed by the ICD-9-based assessment (p = 0.05). an ICD-9-based coding of perioperative adverse events and major complications in a cohort of spine surgery patients revealed an overall complication incidence similar to that in a prospectively executed measure. In contrast, a retrospective review underestimated complication incidence. The ICD-9-based review captured many medical events of limited clinical import, inflating the overall incidence of adverse events demonstrated by this approach. In multiple categories of major, clinically significant perioperative complications, ICD-9-based and retrospective assessments significantly underestimated complication incidence. These findings illustrate a significant potential weakness and source of inaccuracy in the use of population-based ICD-9 and retrospective complication recording.

Improving everyday prospective memory performance in older adults: comparing cognitive process and strategy training.

PubMed

Brom, Sarah Susanne; Kliegel, Matthias

2014-09-01

Considering the importance of prospective memory for independence in old age recently, research has started to examine interventions to reduce prospective memory errors. Two general approaches can be proposed: (a) process training of executive control associated with prospective memory functioning, and/or (b) strategy training to reduce executive task demands. The present study was the first to combine and compare both training methods in a sample of 62 community-dwelling older adults (60-86 years) and to explore their effects on an ecologically valid everyday life prospective memory task (here: regular blood pressure monitoring). Even though the training of executive control was successful in enhancing the trained ability, clear transfer effects on prospective memory performance could only be found for the strategy training. However, participants with low executive abilities benefited particularly from the implementation intention strategy. Conceptually, this supports models suggesting interactions between task demands and individual differences in executive control in explaining individual differences in prospective memory performance. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Regression Discontinuity in Prospective Evaluations: The Case of the FFVP Evaluation

ERIC Educational Resources Information Center

Klerman, Jacob Alex; Olsho, Lauren E. W.; Bartlett, Susan

2015-01-01

While regression discontinuity has usually been applied retrospectively to secondary data, it is even more attractive when applied prospectively. In a prospective design, data collection can be focused on cases near the discontinuity, thereby improving internal validity and substantially increasing precision. Furthermore, such prospective…

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.

Validation of the prognostic gene portfolio, ClinicoMolecular Triad Classification, using an independent prospective breast cancer cohort and external patient populations.

PubMed

Wang, Dong-Yu; Done, Susan J; Mc Cready, David R; Leong, Wey L

2014-07-04

Using genome-wide expression profiles of a prospective training cohort of breast cancer patients, ClinicoMolecular Triad Classification (CMTC) was recently developed to classify breast cancers into three clinically relevant groups to aid treatment decisions. CMTC was found to be both prognostic and predictive in a large external breast cancer cohort in that study. This study serves to validate the reproducibility of CMTC and its prognostic value using independent patient cohorts. An independent internal cohort (n = 284) and a new external cohort (n = 2,181) were used to validate the association of CMTC between clinicopathological factors, 12 known gene signatures, two molecular subtype classifiers, and 19 oncogenic signalling pathway activities, and to reproduce the abilities of CMTC to predict clinical outcomes of breast cancer. In addition, we also updated the outcome data of the original training cohort (n = 147). The original training cohort reached a statistically significant difference (p < 0.05) in disease-free survivals between the three CMTC groups after an additional two years of follow-up (median = 55 months). The prognostic value of the triad classification was reproduced in the second independent internal cohort and the new external validation cohort. CMTC achieved even higher prognostic significance when all available patients were analyzed (n = 4,851). Oncogenic pathways Myc, E2F1, Ras and β-catenin were again implicated in the high-risk groups. Both prospective internal cohorts and the independent external cohorts reproduced the triad classification of CMTC and its prognostic significance. CMTC is an independent prognostic predictor, and it outperformed 12 other known prognostic gene signatures, molecular subtype classifications, and all other standard prognostic clinicopathological factors. Our results support further development of CMTC portfolio into a guide for personalized breast cancer treatments.

Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study.

PubMed

Dobbie, Fiona; Hiscock, Rosemary; Leonardi-Bee, Jo; Murray, Susan; Shahab, Lion; Aveyard, Paul; Coleman, Tim; McEwen, Andy; McRobbie, Hayden; Purves, Richard; Bauld, Linda

2015-11-01

NHS Stop Smoking Services (SSSs) provide free at the point of use treatment for smokers who would like to stop. Since their inception in 1999 they have evolved to offer a variety of support options. Given the changes that have happened in the provision of services and the ongoing need for evidence on effectiveness, the Evaluating Long-term Outcomes for NHS Stop Smoking Services (ELONS) study was commissioned. The main aim of the study was to explore the factors that determine longer-term abstinence from smoking following intervention by SSSs. There were also a number of additional objectives. The ELONS study was an observational study with two main stages: secondary analysis of routine data collected by SSSs and a prospective cohort study of service clients. The prospective study had additional elements on client satisfaction, well-being and longer-term nicotine replacement therapy (NRT) use. The setting for the study was SSSs in England. For the secondary analysis, routine data from 49 services were obtained. For the prospective study and its added elements, nine services were involved. The target population was clients of these services. There were 202,804 cases included in secondary analysis and 3075 in the prospective study. A combination of behavioural support and stop smoking medication delivered by SSS practitioners. Abstinence from smoking at 4 and 52 weeks after setting a quit date, validated by a carbon monoxide (CO) breath test. Just over 4 in 10 smokers (41%) recruited to the prospective study were biochemically validated as abstinent from smoking at 4 weeks (which was broadly comparable with findings from the secondary analysis of routine service data, where self-reported 4-week quit rates were 48%, falling to 34% when biochemical validation had occurred). At the 1-year follow-up, 8% of prospective study clients were CO validated as abstinent from smoking. Clients who received specialist one-to-one behavioural support were twice as likely to have remained abstinent than those who were seen by a general practitioner (GP) practice and pharmacy providers [odds ratio (OR) 2.3, 95% confidence interval (CI) 1.2 to 4.6]. Clients who received group behavioural support (either closed or rolling groups) were three times more likely to stop smoking than those who were seen by a GP practice or pharmacy providers (OR 3.4, 95% CI 1.7 to 6.7). Satisfaction with services was high and well-being at baseline was found to be a predictor of abstinence from smoking at longer-term follow-up. Continued use of NRT at 1 year was rare, but no evidence of harm from longer-term use was identified from the data collected. Stop Smoking Services in England are effective in helping smokers to move away from tobacco use. Using the 52-week CO-validated quit rate of 8% found in this study, we estimate that in the year 2012-13 the services supported 36,249 clients to become non-smokers for the remainder of their lives. This is a substantial figure and provides one indicator of the ongoing value of the treatment that the services provide. The study raises a number of issues for future research including (1) examining the role of electronic cigarettes (e-cigarettes) in smoking cessation for service clients [this study did not look at e-cigarette use (except briefly in the longer-term NRT study) but this is a priority for future studies]; (2) more detailed comparisons of rolling groups with other forms of behavioural support; (3) further exploration of the role of practitioner knowledge, skills and use of effective behaviour change techniques in supporting service clients to stop smoking; (4) surveillance of the impact of structural and funding changes on the future development and sustainability of SSSs; and (5) more detailed analysis of well-being over time between those who successfully stop smoking and those who relapse. Further research on longer-term use of non-combustible nicotine products that measures a wider array of biomarkers of smoking-related harm such as lung function tests or carcinogen metabolites. The National Institute for Health Research Health Technology Assessment programme. The UK Centre for Tobacco and Alcohol Studies provided funding for the longer-term NRT study.

Performance of the quantitative food frequency questionnaire used in the Brazilian center of the prospective study Natural History of Human Papillomavirus Infection in Men: The HIM Study.

PubMed

Teixeira, Juliana Araujo; Baggio, Maria Luiza; Giuliano, Anna R; Fisberg, Regina Mara; Marchioni, Dirce Maria Lobo

2011-07-01

The Natural History of Human Papillomavirus (HPV) Infection in Men: The HIM Study is a prospective multicenter cohort study that, among other factors, analyzes participants' diet. A parallel cross-sectional study was designed to evaluate the validity and reproducibility of the quantitative food frequency questionnaire (QFFQ) used in the Brazilian center from the HIM Study. For this, a convenience subsample of 98 men aged 18 to 70 years from the HIM Study in Brazil answered three 54-item QFFQ and three 24-hour recall interviews, with 6-month intervals between them (data collection January to September 2007). A Bland-Altman analysis indicated that the difference between instruments was dependent on the magnitude of the intake for energy and most nutrients included in the validity analysis, with the exception of carbohydrates, fiber, polyunsaturated fat, vitamin C, and vitamin E. The correlation between the QFFQ and the 24-hour recall for the deattenuated and energy-adjusted data ranged from 0.05 (total fat) to 0.57 (calcium). For the energy and nutrients consumption included in the validity analysis, 33.5% of participants on average were correctly classified into quartiles, and the average value of 0.26 for weighted kappa shows a reasonable agreement. The intraclass correlation coefficients for all nutrients were greater than 0.40 in the reproducibility analysis. The QFFQ demonstrated good reproducibility and acceptable validity. The results support the use of this instrument in the HIM Study. Copyright © 2011 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Emerging indications of endoscopic radiofrequency ablation

PubMed Central

Becq, Aymeric; Camus, Marine; Rahmi, Gabriel; de Parades, Vincent; Marteau, Philippe

2015-01-01

Introduction Radiofrequency ablation (RFA) is a well-validated treatment of dysplastic Barrett's esophagus. Other indications of endoscopic RFA are under evaluation. Results Four prospective studies (total 69 patients) have shown that RFA achieved complete remission of early esophageal squamous intra-epithelial neoplasia at a rate of 80%, but with a substantial risk of stricture. In the setting of gastric antral vascular ectasia, two prospective monocenter studies, and a retrospective multicenter study, (total 51 patients), suggest that RFA is efficacious in terms of reducing transfusion dependency. In the setting of chronic hemorrhagic radiation proctopathy, a prospective monocenter study and a retrospective multicenter study (total 56 patients) suggest that RFA is an efficient treatment. A retrospective comparative study (64 patients) suggests that RFA improves stents patency in malignant biliary strictures. Conclusions Endoscopic RFA is an upcoming treatment modality in early esophageal squamous intra-epithelial neoplasia, as well as in gastric, rectal, and biliary diseases. PMID:26279839

Development and Validation of a Novel Robotic Procedure Specific Simulation Platform: Partial Nephrectomy.

PubMed

Hung, Andrew J; Shah, Swar H; Dalag, Leonard; Shin, Daniel; Gill, Inderbir S

2015-08-01

We developed a novel procedure specific simulation platform for robotic partial nephrectomy. In this study we prospectively evaluate its face, content, construct and concurrent validity. This hybrid platform features augmented reality and virtual reality. Augmented reality involves 3-dimensional robotic partial nephrectomy surgical videos overlaid with virtual instruments to teach surgical anatomy, technical skills and operative steps. Advanced technical skills are assessed with an embedded full virtual reality renorrhaphy task. Participants were classified as novice (no surgical training, 15), intermediate (less than 100 robotic cases, 13) or expert (100 or more robotic cases, 14) and prospectively assessed. Cohort performance was compared with the Kruskal-Wallis test (construct validity). Post-study questionnaire was used to assess the realism of simulation (face validity) and usefulness for training (content validity). Concurrent validity evaluated correlation between virtual reality renorrhaphy task and a live porcine robotic partial nephrectomy performance (Spearman's analysis). Experts rated the augmented reality content as realistic (median 8/10) and helpful for resident/fellow training (8.0-8.2/10). Experts rated the platform highly for teaching anatomy (9/10) and operative steps (8.5/10) but moderately for technical skills (7.5/10). Experts and intermediates outperformed novices (construct validity) in efficiency (p=0.0002) and accuracy (p=0.002). For virtual reality renorrhaphy, experts outperformed intermediates on GEARS metrics (p=0.002). Virtual reality renorrhaphy and in vivo porcine robotic partial nephrectomy performance correlated significantly (r=0.8, p <0.0001) (concurrent validity). This augmented reality simulation platform displayed face, content and construct validity. Performance in the procedure specific virtual reality task correlated highly with a porcine model (concurrent validity). Future efforts will integrate procedure specific virtual reality tasks and their global assessment. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

A prospective study of the validity of self-reported use of specific types of dental services.

PubMed

Gilbert, Gregg H; Rose, John S; Shelton, Brent J

2003-01-01

The purpose of this study was to quantify the validity of self-reported receipt of dental services in 10 categories, using information from dental charts as the "gold standard." The Florida Dental Care Study was a prospective cohort study of a diverse sample of adults. In-person interviews were conducted at baseline and at 24 and 48 months following baseline, with telephone interviews at six-month intervals in between. Participants reported new dental visits, reason(s) for the visit(s), and specific service(s) received. For the present study, self-reported data were compared with data from patients' dental charts. Percent concordance between self-report and dental charts ranged from 82% to 100%, while Kappa values ranged from 0.33 to 0.91. Bivariate multiple logistic regressions were performed for each of the service categories, with two outcomes: self-reported service receipt and service receipt determined from the dental chart. Parameter estimate intervals overlapped for each of the four hypothesized predictors of service receipt (age group, sex, "race" defined as non-Hispanic African American vs. non-Hispanic white, and annual household income < 20,000 US dollars vs. > or = 20,000 US dollars), although for five of the 10 service categories, there were differences in conclusions about statistical significance for certain predictors. The validity of self-reported use of dental services ranged from poor to excellent, depending upon the service type. Regression estimates using either the self-reported or chart-validated measure yielded similar results overall, but conclusions about key predictors of service use differed in some instances. Self-reported dental service use is valid for some, but not all, service types.

The impact of nutritional status and longitudinal recovery of motor and cognitive milestones in internationally adopted children.

PubMed

Park, Hyun; Bothe, Denise; Holsinger, Eva; Kirchner, H Lester; Olness, Karen; Mandalakas, Anna

2011-01-01

Internationally adopted children often arrive from institutional settings where they have experienced medical, nutritional and psychosocial deprivation. This study uses a validated research assessment tool to prospectively assess the impact of baseline (immediately post adoption) nutritional status on fifty-eight children as measured by weight-for-age, height-for-age, weight-for-height and head circumference-for-age z scores, as a determinant of cognitive (MDI) and psychomotor development (PDI) scores longitudinally. A statistical model was developed to allow for different ages at time of initial assessment as well as variable intervals between follow up visits. The study results show that both acute and chronic measures of malnutrition significantly affect baseline developmental status as well as the rate of improvement in both MDI and PDI scores. This study contributes to the body of literature with its prospective nature, unique statistical model for longitudinal evaluation, and use of a validated assessment tool to assess outcomes.

A prospective cohort study to refine and validate the Panic Screening Score for identifying panic attacks associated with unexplained chest pain in the emergency department

PubMed Central

Foldes-Busque, Guillaume; Denis, Isabelle; Poitras, Julien; Fleet, Richard P; Archambault, Patrick; Dionne, Clermont E

2013-01-01

Introduction Panic-like anxiety (panic attacks with or without panic disorder), a highly treatable condition, is the most prevalent condition associated with unexplained chest pain in the emergency department. Panic-like anxiety may be responsible for a significant portion of the negative consequences of unexplained chest pain, such as functional limitations and chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the time of discharge from the emergency department. The 4-item Panic Screening Score (PSS) questionnaire was derived in order to increase the identification of panic-like anxiety in emergency department patients with unexplained chest pain. Methods and analysis The goals of this prospective cohort study were to (1) refine the PSS; (2) validate the revised version of the PSS; (3) measure the reliability of the revised version of the PSS and (4) assess the acceptability of the instrument among emergency physicians. Eligible and consenting patients will be administered the PSS in a large emergency department. Patients will be contacted by phone for administration of the criterion standard for panic attacks as well as by a standardised interview to collect information for other predictors of panic attacks. Multivariate analysis will be used to refine the PSS. The new version will be prospectively validated in an independent sample and inter-rater agreement will be assessed in 10% of cases. The screening instrument acceptability will be assessed with the Ottawa Acceptability of Decision Rules Instrument. Ethics and dissemination This study protocol has been reviewed and approved by the Alphonse-Desjardins research ethics committee. The results of the study will be presented in scientific conferences and published in peer-reviewed scientific journals. Further dissemination via workshops and a dedicated website is planned. PMID:24163208

Predictive Accuracy of the Liverpool Lung Project Risk Model for Stratifying Patients for Computed Tomography Screening for Lung Cancer

PubMed Central

Raji, Olaide Y.; Duffy, Stephen W.; Agbaje, Olorunshola F.; Baker, Stuart G.; Christiani, David C.; Cassidy, Adrian; Field, John K.

2013-01-01

Background External validation of existing lung cancer risk prediction models is limited. Using such models in clinical practice to guide the referral of patients for computed tomography (CT) screening for lung cancer depends on external validation and evidence of predicted clinical benefit. Objective To evaluate the discrimination of the Liverpool Lung Project (LLP) risk model and demonstrate its predicted benefit for stratifying patients for CT screening by using data from 3 independent studies from Europe and North America. Design Case–control and prospective cohort study. Setting Europe and North America. Patients Participants in the European Early Lung Cancer (EUELC) and Harvard case–control studies and the LLP population-based prospective cohort (LLPC) study. Measurements 5-year absolute risks for lung cancer predicted by the LLP model. Results The LLP risk model had good discrimination in both the Harvard (area under the receiver-operating characteristic curve [AUC], 0.76 [95% CI, 0.75 to 0.78]) and the LLPC (AUC, 0.82 [CI, 0.80 to 0.85]) studies and modest discrimination in the EUELC (AUC, 0.67 [CI, 0.64 to 0.69]) study. The decision utility analysis, which incorporates the harms and benefit of using a risk model to make clinical decisions, indicates that the LLP risk model performed better than smoking duration or family history alone in stratifying high-risk patients for lung cancer CT screening. Limitations The model cannot assess whether including other risk factors, such as lung function or genetic markers, would improve accuracy. Lack of information on asbestos exposure in the LLPC limited the ability to validate the complete LLP risk model. Conclusion Validation of the LLP risk model in 3 independent external data sets demonstrated good discrimination and evidence of predicted benefits for stratifying patients for lung cancer CT screening. Further studies are needed to prospectively evaluate model performance and evaluate the optimal population risk thresholds for initiating lung cancer screening. Primary Funding Source Roy Castle Lung Cancer Foundation. PMID:22910935

Development and validation of a clinical prediction rule to identify suspected breast cancer: a prospective cohort study.

PubMed

Galvin, Rose; Joyce, Doireann; Downey, Eithne; Boland, Fiona; Fahey, Tom; Hill, Arnold K

2014-10-03

The number of primary care referrals of women with breast symptoms to symptomatic breast units (SBUs) has increased exponentially in the past decade in Ireland. The aim of this study is to develop and validate a clinical prediction rule (CPR) to identify women with breast cancer so that a more evidence based approach to referral from primary care to these SBUs can be developed. We analysed routine data from a prospective cohort of consecutive women reviewed at a SBU with breast symptoms. The dataset was split into a derivation and validation cohort. Regression analysis was used to derive a CPR from the patient's history and clinical findings. Validation of the CPR consisted of estimating the number of breast cancers predicted to occur compared with the actual number of observed breast cancers across deciles of risk. A total of 6,590 patients were included in the derivation study and 4.9% were diagnosed with breast cancer. Independent clinical predictors for breast cancer were: increasing age by year (adjusted odds ratio 1.08, 95% CI 1.07-1.09); presence of a lump (5.63, 95% CI 4.2-7.56); nipple change (2.77, 95% CI 1.68-4.58) and nipple discharge (2.09, 95% CI 1.1-3.97). Validation of the rule (n = 911) demonstrated that the probability of breast cancer was higher with an increasing number of these independent variables. The Hosmer-Lemeshow goodness of fit showed no overall significant difference between the expected and the observed numbers of breast cancer (χ(2)HL: 6.74, p-value: 0.56). This study derived and validated a CPR for breast cancer in women attending an Irish national SBU. We found that increasing age, presence of a lump, nipple discharge and nipple change are all associated with increased risk of breast cancer. Further validation of the rule is necessary as well as an assessment of its impact on referral practice.

Derivation and Validation of a Biomarker-Based Clinical Algorithm to Rule Out Sepsis From Noninfectious Systemic Inflammatory Response Syndrome at Emergency Department Admission: A Multicenter Prospective Study.

PubMed

Mearelli, Filippo; Fiotti, Nicola; Giansante, Carlo; Casarsa, Chiara; Orso, Daniele; De Helmersen, Marco; Altamura, Nicola; Ruscio, Maurizio; Castello, Luigi Mario; Colonetti, Efrem; Marino, Rossella; Barbati, Giulia; Bregnocchi, Andrea; Ronco, Claudio; Lupia, Enrico; Montrucchio, Giuseppe; Muiesan, Maria Lorenza; Di Somma, Salvatore; Avanzi, Gian Carlo; Biolo, Gianni

2018-05-07

To derive and validate a predictive algorithm integrating a nomogram-based prediction of the pretest probability of infection with a panel of serum biomarkers, which could robustly differentiate sepsis/septic shock from noninfectious systemic inflammatory response syndrome. Multicenter prospective study. At emergency department admission in five University hospitals. Nine-hundred forty-seven adults in inception cohort and 185 adults in validation cohort. None. A nomogram, including age, Sequential Organ Failure Assessment score, recent antimicrobial therapy, hyperthermia, leukocytosis, and high C-reactive protein values, was built in order to take data from 716 infected patients and 120 patients with noninfectious systemic inflammatory response syndrome to predict pretest probability of infection. Then, the best combination of procalcitonin, soluble phospholypase A2 group IIA, presepsin, soluble interleukin-2 receptor α, and soluble triggering receptor expressed on myeloid cell-1 was applied in order to categorize patients as "likely" or "unlikely" to be infected. The predictive algorithm required only procalcitonin backed up with soluble phospholypase A2 group IIA determined in 29% of the patients to rule out sepsis/septic shock with a negative predictive value of 93%. In a validation cohort of 158 patients, predictive algorithm reached 100% of negative predictive value requiring biomarker measurements in 18% of the population. We have developed and validated a high-performing, reproducible, and parsimonious algorithm to assist emergency department physicians in distinguishing sepsis/septic shock from noninfectious systemic inflammatory response syndrome.

Derivation and validation of two decision instruments for selective chest CT in blunt trauma: a multicenter prospective observational study (NEXUS Chest CT).

PubMed

Rodriguez, Robert M; Langdorf, Mark I; Nishijima, Daniel; Baumann, Brigitte M; Hendey, Gregory W; Medak, Anthony J; Raja, Ali S; Allen, Isabel E; Mower, William R

2015-10-01

Unnecessary diagnostic imaging leads to higher costs, longer emergency department stays, and increased patient exposure to ionizing radiation. We sought to prospectively derive and validate two decision instruments (DIs) for selective chest computed tomography (CT) in adult blunt trauma patients. From September 2011 to May 2014, we prospectively enrolled blunt trauma patients over 14 y of age presenting to eight US, urban level 1 trauma centers in this observational study. During the derivation phase, physicians recorded the presence or absence of 14 clinical criteria before viewing chest imaging results. We determined injury outcomes by CT radiology readings and categorized injuries as major or minor according to an expert-panel-derived clinical classification scheme. We then employed recursive partitioning to derive two DIs: Chest CT-All maximized sensitivity for all injuries, and Chest CT-Major maximized sensitivity for only major thoracic injuries (while increasing specificity). In the validation phase, we employed similar methodology to prospectively test the performance of both DIs. We enrolled 11,477 patients-6,002 patients in the derivation phase and 5,475 patients in the validation phase. The derived Chest CT-All DI consisted of (1) abnormal chest X-ray, (2) rapid deceleration mechanism, (3) distracting injury, (4) chest wall tenderness, (5) sternal tenderness, (6) thoracic spine tenderness, and (7) scapular tenderness. The Chest CT-Major DI had the same criteria without rapid deceleration mechanism. In the validation phase, Chest CT-All had a sensitivity of 99.2% (95% CI 95.4%-100%), a specificity of 20.8% (95% CI 19.2%-22.4%), and a negative predictive value (NPV) of 99.8% (95% CI 98.9%-100%) for major injury, and a sensitivity of 95.4% (95% CI 93.6%-96.9%), a specificity of 25.5% (95% CI 23.5%-27.5%), and a NPV of 93.9% (95% CI 91.5%-95.8%) for either major or minor injury. Chest CT-Major had a sensitivity of 99.2% (95% CI 95.4%-100%), a specificity of 31.7% (95% CI 29.9%-33.5%), and a NPV of 99.9% (95% CI 99.3%-100%) for major injury and a sensitivity of 90.7% (95% CI 88.3%-92.8%), a specificity of 37.9% (95% CI 35.8%-40.1%), and a NPV of 91.8% (95% CI 89.7%-93.6%) for either major or minor injury. Regarding the limitations of our work, some clinicians may disagree with our injury classification and sensitivity thresholds for injury detection. We prospectively derived and validated two DIs (Chest CT-All and Chest CT-Major) that identify blunt trauma patients with clinically significant thoracic injuries with high sensitivity, allowing for a safe reduction of approximately 25%-37% of unnecessary chest CTs. Trauma evaluation protocols that incorporate these DIs may decrease unnecessary costs and radiation exposure in the disproportionately young trauma population.

Risk Factors of Catheter-Related Thrombosis (CRT) in Cancer Patients: A Patient-Level Data (IPD) Meta-Analysis of Clinical Trials and Prospective Studies

PubMed Central

Saber, W.; Moua, T.; Williams, E. C.; Verso, M.; Agnelli, G.; Couban, S.; Young, A.; De Cicco, M.; Biffi, R.; van Rooden, C. J.; Huisman, M. V.; Fagnani, D.; Cimminiello, C.; Moia, M.; Magagnoli, M.; Povoski, S. P.; Malak, S. F.; Lee, A. Y.

2010-01-01

Background Knowledge of independent, baseline risk factors of catheter-related thrombosis (CRT) may help select adult cancer patients at high risk to receive thromboprophylaxis. Objectives We conducted a meta-analysis of individual patient-level data to identify these baseline risk factors. Patients/Methods MEDLINE, EMBASE, CINAHL, CENTRAL, DARE, Grey literature databases were searched in all languages from 1995-2008. Prospective studies and randomized controlled trials (RCTs) were eligible. Studies were included if original patient-level data were provided by the investigators and if CRT was objectively confirmed with valid imaging. Multivariate logistic regression analysis of 17 prespecified baseline characteristics was conducted. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were estimated. Results A total sample of 5636 subjects from 5 RCTs and 7 prospective studies was included in the analysis. Among these subjects, 425 CRT events were observed. In multivariate logistic regression, the use of implanted ports as compared with peripherally implanted central venous catheters (PICC), decreased CRT risk (OR = 0.43; 95% CI, 0.23-0.80), whereas past history of deep vein thrombosis (DVT) (OR = 2.03; 95% CI, 1.05-3.92), subclavian venipuncture insertion technique (OR = 2.16; 95% CI, 1.07-4.34), and improper catheter tip location (OR = 1.92; 95% CI, 1.22-3.02), increased CRT risk. Conclusions CRT risk is increased with using PICC catheters, previous history of DVT, subclavian venipuncture insertion technique and improper positioning of the catheter tip. These factors may be useful for risk stratifying patients to select those for thromboprophylaxis. Prospective studies are needed to validate these findings. PMID:21040443

External validation of the HIT Expert Probability (HEP) score.

PubMed

Joseph, Lee; Gomes, Marcelo P V; Al Solaiman, Firas; St John, Julie; Ozaki, Asuka; Raju, Manjunath; Dhariwal, Manoj; Kim, Esther S H

2015-03-01

The diagnosis of heparin-induced thrombocytopenia (HIT) can be challenging. The HIT Expert Probability (HEP) Score has recently been proposed to aid in the diagnosis of HIT. We sought to externally and prospectively validate the HEP score. We prospectively assessed pre-test probability of HIT for 51 consecutive patients referred to our Consultative Service for evaluation of possible HIT between August 1, 2012 and February 1, 2013. Two Vascular Medicine fellows independently applied the 4T and HEP scores for each patient. Two independent HIT expert adjudicators rendered a diagnosis of HIT likely or unlikely. The median (interquartile range) of 4T and HEP scores were 4.5 (3.0, 6.0) and 5 (3.0, 8.5), respectively. There were no significant differences between area under receiver-operating characteristic curves of 4T and HEP scores against the gold standard, confirmed HIT [defined as positive serotonin release assay and positive anti-PF4/heparin ELISA] (0.74 vs 0.73, p = 0.97). HEP score ≥ 2 was 100 % sensitive and 16 % specific for determining the presence of confirmed HIT while a 4T score > 3 was 93 % sensitive and 35 % specific. In conclusion, the HEP and 4T scores are excellent screening pre-test probability models for HIT, however, in this prospective validation study, test characteristics for the diagnosis of HIT based on confirmatory laboratory testing and expert opinion are similar. Given the complexity of the HEP scoring model compared to that of the 4T score, further validation of the HEP score is warranted prior to widespread clinical acceptance.

EDRN Pre-Validation of Multiplex Biomarker in Urine — EDRN Public Portal

Cancer.gov

The goal of this proposal is to begin to establish an EDRN “pre-validation” trial of a multiplex set of transcripts, including the ETS gene fusions, in post-DRE urine sediments. As can be evidenced by our preliminary data, we have established the utility of this multiplex urine test (which includes TMPRSS-ERG, SPINK1, PCA3 and GOLPH2) in a cohort of prospectively collected urine sediments from the University of Michigan EDRN CEVC site (collected by co-I, Dr. John Wei). In this proposal, we will run this multiplex assay on prospectively collected post-DRE urines collected from other EDRN sites. The idea is to couple this “pre-validation” study with an EDRN validation trial under consideration for the Gen-Probe PCA3 urine test (directed by Drs. John Wei and Harry Rittenhouse).

Validation of the German version of the Nurse-Work Instability Scale: baseline survey findings of a prospective study of a cohort of geriatric care workers

PubMed Central

2013-01-01

Background A prospective study of a cohort of nursing staff from nursing homes was undertaken to validate the Nurse-Work Instability Scale (Nurse-WIS). Baseline investigation data was used to test reliability, construct validity and criterion validity. Method A survey of nursing staff from nursing homes was conducted using a questionnaire containing the Nurse-WIS along with other survey instruments (including SF-12, WAI, SPE). The self-reported number of days’ sick leave taken and if a pension for reduced work capacity was drawn were recorded. The reliability of the scale was checked by item difficulty (P), item discrimination (rjt) and by internal consistency according to Cronbach’s coefficient. The hypotheses for checking construct validity were tested on the basis of correlations. Pearson’s chi-square was used to test concurrent criterion validity; discriminant validity was tested by means of binary logistic regression. Results 396 persons answered the questionnaire (21.3% response rate). More than 80% were female and mostly work full-time in a rotating shift pattern. Following the test for item discrimination, two items were removed from the Nurse-WIS test. According to Cronbach’s (0.927) the scale provides a high degree of measuring accuracy. All hypotheses and assumptions used to test validity were confirmed: As the Nurse-WIS risk increases, health-related quality of life, work ability and job satisfaction decline. Depressive symptoms and a poor subjective prognosis of earning capacity are also more frequent. Musculoskeletal disorders and impairments of psychological well-being are more frequent. Age also influences the Nurse-WIS result. While 12.0% of those below the age of 35 had an increased risk, the figure for those aged over 55 was 50%. Conclusion This study is the first validation study of the Nurse-WIS to date. The Nurse-WIS shows good reliability, good validity and a good level of measuring accuracy. It appears to be suitable for recording prevention and rehabilitation needs among health care workers. If, in the follow-up, the Nurse-WIS likewise proves to be a reliable screening instrument with good predictive validity, it could ensure that suitable action is taken at an early stage, thereby helping to counteract early retirement and the anticipated shortage of health care workers. PMID:24330532

Toward Making the Invisible Visible Using a Scale: Prospective Teachers' Thoughts and Affective Reactions to Feedback

ERIC Educational Resources Information Center

Akkuzu, Nalan; Uyulgan, Melis Arzu

2014-01-01

This paper presents the development and initial validation of a feedback scale which measures the thoughts and affective reactions of prospective teachers concerning feedback on their teaching experiences. To reach this goal, data from 512 prospective teachers were used to test the internal consistency, exploratory and confirmative factor…

Validity of a PCR assay in CSF for the diagnosis of neurocysticercosis.

PubMed

Carpio, Arturo; Campoverde, Alfredo; Romo, Matthew L; García, Lorena; Piedra, Luis M; Pacurucu, Mónica; López, Nelson; Aguilar, Jenner; López, Sebastian; Vintimilla, Luis C; Toral, Ana M; Peña-Tapia, Pablo

2017-03-01

To prospectively evaluate the validity of a PCR assay in CSF for the diagnosis of neurocysticercosis (NC). We conducted a multicenter, prospective case-control study, recruiting participants from 5 hospitals in Cuenca, Ecuador, from January 2015 to February 2016. Cases fulfilled validated diagnostic criteria for NC. For each case, a neurosurgical patient who did not fulfill the diagnostic criteria for NC was selected as a control. CT and MRI, as well as a CSF sample, were collected from both cases and controls. The diagnostic criteria to identify cases were used as a reference standard. Overall, 36 case and 36 control participants were enrolled. PCR had a sensitivity of 72.2% (95% confidence interval [CI] 54.8%-85.8%) and a specificity of 100.0% (95% CI 90.3%-100.0%). For parenchymal NC, PCR had a sensitivity of 42.9% (95% CI 17.7%-71.1%), and for extraparenchymal NC, PCR had a sensitivity of 90.9% (95% CI 70.8%-98.9%). This study demonstrated the usefulness of this PCR assay in CSF for the diagnosis of NC. PCR may be particularly helpful for diagnosing extraparenchymal NC when neuroimaging techniques have failed. This study provides Class III evidence that CSF PCR can accurately identify patients with extraparenchymal NC.

A prospective study evaluating cochlear implant management skills: development and validation of the Cochlear Implant Management Skills survey.

PubMed

Bennett, R J; Jayakody, D M P; Eikelboom, R H; Taljaard, D S; Atlas, M D

2016-02-01

To investigate the ability of cochlear implant (CI) recipients to physically handle and care for their hearing implant device(s) and to identify factors that may influence skills. To assess device management skills, a clinical survey was developed and validated on a clinical cohort of CI recipients. Survey development and validation. A prospective convenience cohort design study. Specialist hearing implant clinic. Forty-nine post-lingually deafened, adult CI recipients, at least 12 months postoperative. Survey test-retest reliability, interobserver reliability and responsiveness. Correlations between management skills and participant demographic, audiometric, clinical outcomes and device factors. The Cochlear Implant Management Skills survey was developed, demonstrating high test-retest reliability (0.878), interobserver reliability (0.972) and responsiveness to intervention (skills training) [t(20) = -3.913, P = 0.001]. Cochlear Implant Management Skills survey scores range from 54.69% to 100% (mean: 83.45%, sd: 12.47). No associations were found between handling skills and participant factors. This is the first study to demonstrate a range in cochlear implant device handling skills in CI recipients and offers clinicians and researchers a tool to systematically and objectively identify shortcomings in CI recipients' device handling skills. © 2015 John Wiley & Sons Ltd.

Prospective patients rate practice factors: development of a questionnaire.

PubMed

St Louis, Brian Lingg; Firestone, Allen R; Johnston, William; Shanker, Shiva; Vig, Katherine W L

2011-02-01

The importance that prospective patients place on practice characteristics when choosing an orthodontic practice has not been extensively reported. The objective of this research was to develop a valid and reliable questionnaire to address the relative importance of orthodontic office and doctor characteristics for prospective patients or parents of child patients during the initial orthodontic office consultation. An initial questionnaire, based on published literature, was field-tested on 16 subjects to assess its validity. Based on the field test, the questionnaire was modified and tested for reliability by using a test-retest method. The questionnaire covered the following areas: doctor, office, staff, and finances. The reliability study included 2 groups of subjects: 12 consecutive prospective adult patients and 41 consecutive parents of prospective child patients. The questionnaires consisted of 43 and 50 questions for the adult patients and the parents of patients, respectively. The subjects rated the importance of practice characteristics in their selection of an orthodontic practice using a 100-mm visual analog scale anchored at "not important at all" and "most important." Reliability was analyzed by using the intraclass correlation coefficient (ICC). Summary scores of all 53 subjects showed excellent reliability (ICC, 0.88; range, 0.61-1.0). Summary scores of all 50 questions showed acceptable reliability (ICC, 0.70; range, 0.45-0.88). Twenty-one questions had excellent reliability (ICC, >.75), and 29 questions had fair-to-good reliability (ICC, 0.41-0.75). No questions showed poor reliability (ICC, <0.4). The pilot study data indicated that the overall reliability of the questionnaire is acceptable. Copyright © 2011 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Validation of a Delirium Risk Assessment Using Electronic Medical Record Information.

PubMed

Rudolph, James L; Doherty, Kelly; Kelly, Brittany; Driver, Jane A; Archambault, Elizabeth

2016-03-01

Identifying patients at risk for delirium allows prompt application of prevention, diagnostic, and treatment strategies; but is rarely done. Once delirium develops, patients are more likely to need posthospitalization skilled care. This study developed an a priori electronic prediction rule using independent risk factors identified in a National Center of Clinical Excellence meta-analysis and validated the ability to predict delirium in 2 cohorts. Retrospective analysis followed by prospective validation. Tertiary VA Hospital in New England. A total of 27,625 medical records of hospitalized patients and 246 prospectively enrolled patients admitted to the hospital. The electronic delirium risk prediction rule was created using data obtained from the patient electronic medical record (EMR). The primary outcome, delirium, was identified 2 ways: (1) from the EMR (retrospective cohort) and (2) clinical assessment on enrollment and daily thereafter (prospective participants). We assessed discrimination of the delirium prediction rule with the C-statistic. Secondary outcomes were length of stay and discharge to rehabilitation. Retrospectively, delirium was identified in 8% of medical records (n = 2343); prospectively, delirium during hospitalization was present in 26% of participants (n = 64). In the retrospective cohort, medical record delirium was identified in 2%, 3%, 11%, and 38% of the low, intermediate, high, and very high-risk groups, respectively (C-statistic = 0.81; 95% confidence interval 0.80-0.82). Prospectively, the electronic prediction rule identified delirium in 15%, 18%, 31%, and 55% of these groups (C-statistic = 0.69; 95% confidence interval 0.61-0.77). Compared with low-risk patients, those at high- or very high delirium risk had increased length of stay (5.7 ± 5.6 vs 3.7 ± 2.7 days; P = .001) and higher rates of discharge to rehabilitation (8.9% vs 20.8%; P = .02). Automatic calculation of delirium risk using an EMR algorithm identifies patients at risk for delirium, which creates a critical opportunity for gaining clinical efficiencies and improving delirium identification, including those needing skilled care. Published by Elsevier Inc.

The development and validation of an instrument to measure preservice teachers' self-efficacy in regard to the teaching of science as inquiry

NASA Astrophysics Data System (ADS)

Dira-Smolleck, Lori

The purpose of this study was to develop, validate and establish the reliability of an instrument that measures preservice teachers' self-efficacy in regard to the teaching of science as inquiry. The instrument (TSI) is based upon the work of Bandura, Riggs, and Enochs & Riggs (1990). The study used Bandura's theoretical framework in that the instrument uses the self-efficacy construct to explore the beliefs of prospective elementary science teachers with regards to the teaching of science through inquiry: specifically, the two dimensions of self-efficacy beliefs defined by Bandura: personal self-efficacy and outcome expectancy. Self-efficacy in regard to the teaching of science as inquiry was measured through the use of a 69-item Likert scale instrument designed by the author of the study. A 13-step plan was designed and followed in the process of developing the instrument. Using the results from Chronbach Alpha and Analysis of Variance, a 69-item instrument was found to achieve the greatest balance across the construct validity, reliability and item balance with the Essential Elements of Classroom Inquiry content matrix. Based on the standardized development processes used and the associated evidence, the TSI appears to be a content and construct valid instrument, with high internal reliability for use with prospective elementary teachers to assess self-efficacy beliefs in regard to the teaching of science as inquiry. Implications for research, policy and practice are also discussed.

Measuring the Relationship between Self-Efficacy and Math Performance among First-Generation College-Bound Middle School Students

ERIC Educational Resources Information Center

Carpenter, Dick M., II; Clayton, Grant

2014-01-01

Using confirmatory factor analysis, this study examines the validity of the Usher and Pajares Sources of Self-Efficacy in Mathematics (SSEM) for prospective or eventual first-generation college students while still in middle school, a population not studied with the SSEM heretofore. Studying this population is especially noteworthy as educators…

Assessing Psychosocial Impairment in the Pediatric Emergency Department: Child/Caregiver Concordance

ERIC Educational Resources Information Center

Montano, Zorash; Mahrer, Nicole E.; Nager, Alan L.; Claudius, Ilene; Gold, Jeffrey I.

2011-01-01

The objective of this study was to examine the level of agreement between child- and caregiver-reports of the child's psychosocial problems presenting to a Pediatric Emergency Department (PED) using a validated screening tool. This was an anonymous, prospective, cross-sectional, multi-informant (child and caregiver) study assessing cognitive,…

Development and validation of a paediatric long-bone fracture classification. A prospective multicentre study in 13 European paediatric trauma centres

PubMed Central

2011-01-01

Background The aim of this study was to develop a child-specific classification system for long bone fractures and to examine its reliability and validity on the basis of a prospective multicentre study. Methods Using the sequentially developed classification system, three samples of between 30 and 185 paediatric limb fractures from a pool of 2308 fractures documented in two multicenter studies were analysed in a blinded fashion by eight orthopaedic surgeons, on a total of 5 occasions. Intra- and interobserver reliability and accuracy were calculated. Results The reliability improved with successive simplification of the classification. The final version resulted in an overall interobserver agreement of κ = 0.71 with no significant difference between experienced and less experienced raters. Conclusions In conclusion, the evaluation of the newly proposed classification system resulted in a reliable and routinely applicable system, for which training in its proper use may further improve the reliability. It can be recommended as a useful tool for clinical practice and offers the option for developing treatment recommendations and outcome predictions in the future. PMID:21548939

[The Amsterdam wrist rules: the multicenter prospective derivation and external validation of a clinical decision rule for the use of radiography in acute wrist trauma].

PubMed

Walenkamp, Monique M J; Bentohami, Abdelali; Slaar, Annelie; Beerekamp, M S H Suzan; Maas, Mario; Jager, L C Cara; Sosef, Nico L; van Velde, Romuald; Ultee, Jan M; Steyerberg, Ewout W; Goslings, J C Carel; Schep, Niels W L

2016-01-01

Although only 39% of patients with wrist trauma have sustained a fracture, the majority of patients is routinely referred for radiography. The purpose of this study was to derive and externally validate a clinical decision rule that selects patients with acute wrist trauma in the Emergency Department (ED) for radiography. This multicenter prospective study consisted of three components: (1) derivation of a clinical prediction model for detecting wrist fractures in patients following wrist trauma; (2) external validation of this model; and (3) design of a clinical decision rule. The study was conducted in the EDs of five Dutch hospitals: one academic hospital (derivation cohort) and four regional hospitals (external validation cohort). We included all adult patients with acute wrist trauma. The main outcome was fracture of the wrist (distal radius, distal ulna or carpal bones) diagnosed on conventional X-rays. A total of 882 patients were analyzed; 487 in the derivation cohort and 395 in the validation cohort. We derived a clinical prediction model with eight variables: age; sex, swelling of the wrist; swelling of the anatomical snuffbox, visible deformation; distal radius tender to palpation; pain on radial deviation and painful axial compression of the thumb. The Area Under the Curve at external validation of this model was 0.81 (95% CI: 0.77-0.85). The sensitivity and specificity of the Amsterdam Wrist Rules (AWR) in the external validation cohort were 98% (95% CI: 95-99%) and 21% (95% CI: 15%-28). The negative predictive value was 90% (95% CI: 81-99%). The Amsterdam Wrist Rules is a clinical prediction rule with a high sensitivity and negative predictive value for fractures of the wrist. Although external validation showed low specificity and 100 % sensitivity could not be achieved, the Amsterdam Wrist Rules can provide physicians in the Emergency Department with a useful screening tool to select patients with acute wrist trauma for radiography. The upcoming implementation study will further reveal the impact of the Amsterdam Wrist Rules on the anticipated reduction of X-rays requested, missed fractures, Emergency Department waiting times and health care costs.

Predicting surgical site infection after spine surgery: a validated model using a prospective surgical registry.

PubMed

Lee, Michael J; Cizik, Amy M; Hamilton, Deven; Chapman, Jens R

2014-09-01

The impact of surgical site infection (SSI) is substantial. Although previous study has determined relative risk and odds ratio (OR) values to quantify risk factors, these values may be difficult to translate to the patient during counseling of surgical options. Ideally, a model that predicts absolute risk of SSI, rather than relative risk or OR values, would greatly enhance the discussion of safety of spine surgery. To date, there is no risk stratification model that specifically predicts the risk of medical complication. The purpose of this study was to create and validate a predictive model for the risk of SSI after spine surgery. This study performs a multivariate analysis of SSI after spine surgery using a large prospective surgical registry. Using the results of this analysis, this study will then create and validate a predictive model for SSI after spine surgery. The patient sample is from a high-quality surgical registry from our two institutions with prospectively collected, detailed demographic, comorbidity, and complication data. An SSI that required return to the operating room for surgical debridement. Using a prospectively collected surgical registry of more than 1,532 patients with extensive demographic, comorbidity, surgical, and complication details recorded for 2 years after the surgery, we identified several risk factors for SSI after multivariate analysis. Using the beta coefficients from those regression analyses, we created a model to predict the occurrence of SSI after spine surgery. We split our data into two subsets for internal and cross-validation of our model. We created a predictive model based on our beta coefficients from our multivariate analysis. The final predictive model for SSI had a receiver-operator curve characteristic of 0.72, considered to be a fair measure. The final model has been uploaded for use on SpineSage.com. We present a validated model for predicting SSI after spine surgery. The value in this model is that it gives the user an absolute percent likelihood of SSI after spine surgery based on the patient's comorbidity profile and invasiveness of surgery. Patients are far more likely to understand an absolute percentage, rather than relative risk and confidence interval values. A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery. In addition, a tool such as this can be of great use particularly as health care trends toward pay for performance, quality metrics (such as SSI), and risk adjustment. To facilitate the use of this model, we have created a Web site (SpineSage.com) where users can enter patient data to determine likelihood for SSI. Copyright © 2014 Elsevier Inc. All rights reserved.

Baseline social amotivation predicts 1-year functioning in UHR subjects: A validation and prospective investigation.

PubMed

Lam, Max; Abdul Rashid, Nur Amirah; Lee, Sara-Ann; Lim, Jeanette; Foussias, George; Fervaha, Gagan; Ruhrman, Stephan; Remington, Gary; Lee, Jimmy

2015-12-01

Social amotivation and diminished expression have been reported to underlie negative symptomatology in schizophrenia. In the current study we sought to establish and validate these negative symptom domains in a large cohort of schizophrenia subjects (n=887) and individuals who are deemed to be Ultra-High Risk (UHR) for psychosis. Confirmatory factor analysis conducted on PANSS item domains demonstrate that the dual negative symptom domains exist in schizophrenia and UHR subjects. We further sought to examine if these negative symptom domains were associated with functioning in UHR subjects. Linear regression analyses confirmed that social amotivation predicted functioning in UHR subjects prospectively at 1 year follow up. Results suggest that the association between social amotivation and functioning is generalisable beyond schizophrenia populations to those who are at-risk of developing psychosis. Social amotivation may be an important dimensional clinical construct to be studied across a range of psychiatric conditions. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

Preoperative risk factors for conversion from laparoscopic to open cholecystectomy: a validated risk score derived from a prospective U.K. database of 8820 patients.

PubMed

Sutcliffe, Robert P; Hollyman, Marianne; Hodson, James; Bonney, Glenn; Vohra, Ravi S; Griffiths, Ewen A

2016-11-01

Laparoscopic cholecystectomy is commonly performed, and several factors increase the risk of open conversion, prolonging operating time and hospital stay. Preoperative stratification would improve consent, scheduling and identify appropriate training cases. The aim of this study was to develop a validated risk score for conversion for use in clinical practice. Preoperative patient and disease-related variables were identified from a prospective cholecystectomy database (CholeS) of 8820 patients, divided into main and validation sets. Preoperative predictors of conversion were identified by multivariable binary logistic regression. A risk score was developed and validated using a forward stepwise approach. Some 297 procedures (3.4%) were converted. The risk score was derived from six significant predictors: age (p = 0.005), sex (p < 0.001), indication for surgery (p < 0.001), ASA (p < 0.001), thick-walled gallbladder (p = 0.040) and CBD diameter (p = 0.004). Testing the score on the validation set yielded an AUROC = 0.766 (p < 0.001), and a score >6 identified patients at high risk of conversion (7.1% vs. 1.2%). This validated risk score allows preoperative identification of patients at six-fold increased risk of conversion to open cholecystectomy. Copyright © 2016 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

Feasibility study of a swept frequency electromagnetic probe (SWEEP) using inductive coupling for the determination of subsurface conductivity of the earth and water prospecting in arid regions

NASA Technical Reports Server (NTRS)

Latorraca, G. A.; Bannister, L. H.

1974-01-01

Techniques developed for electromagnetic probing of the lunar interior, and techniques developed for the generation of high power audio frequencies were combined to make practical a magnetic inductive coupling system for the rapid measurement of ground conductivity profiles which are helpful when prospecting for the presence and quality of subsurface water. A system which involves the measurement of the direction, intensity, and time phase of the magnetic field observed near the surface of the earth at a distance from a horizontal coil energized so as to create a field that penetrates the earth was designed and studied to deduce the conductivity and stratification of the subsurface. Theoretical studies and a rudimentary experiment in an arid region showed that the approach is conceptually valid and that this geophysical prospecting technique can be developed for the economical exploration of subterranean water resources.

Nomogram predicting response after chemoradiotherapy in rectal cancer using sequential PETCT imaging: a multicentric prospective study with external validation.

PubMed

van Stiphout, Ruud G P M; Valentini, Vincenzo; Buijsen, Jeroen; Lammering, Guido; Meldolesi, Elisa; van Soest, Johan; Leccisotti, Lucia; Giordano, Alessandro; Gambacorta, Maria A; Dekker, Andre; Lambin, Philippe

2014-11-01

To develop and externally validate a predictive model for pathologic complete response (pCR) for locally advanced rectal cancer (LARC) based on clinical features and early sequential (18)F-FDG PETCT imaging. Prospective data (i.a. THUNDER trial) were used to train (N=112, MAASTRO Clinic) and validate (N=78, Università Cattolica del S. Cuore) the model for pCR (ypT0N0). All patients received long-course chemoradiotherapy (CRT) and surgery. Clinical parameters were age, gender, clinical tumour (cT) stage and clinical nodal (cN) stage. PET parameters were SUVmax, SUVmean, metabolic tumour volume (MTV) and maximal tumour diameter, for which response indices between pre-treatment and intermediate scan were calculated. Using multivariate logistic regression, three probability groups for pCR were defined. The pCR rates were 21.4% (training) and 23.1% (validation). The selected predictive features for pCR were cT-stage, cN-stage, response index of SUVmean and maximal tumour diameter during treatment. The models' performances (AUC) were 0.78 (training) and 0.70 (validation). The high probability group for pCR resulted in 100% correct predictions for training and 67% for validation. The model is available on the website www.predictcancer.org. The developed predictive model for pCR is accurate and externally validated. This model may assist in treatment decisions during CRT to select complete responders for a wait-and-see policy, good responders for extra RT boost and bad responders for additional chemotherapy. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Validation of SAPS3 admission score and its customization for use in Korean intensive care unit patients: a prospective multicentre study.

PubMed

Lim, So Yeon; Koh, Shin Ok; Jeon, Kyeongman; Na, Sungwon; Lim, Chae-Man; Choi, Won-Il; Lee, Young-Joo; Kim, Seok Chan; Chon, Gyu Rak; Kim, Je Hyeong; Kim, Jae Yeol; Lim, Jaemin; Rhee, Chin Kook; Park, Sunghoon; Kim, Ho Cheol; Lee, Jin Hwa; Lee, Ji Hyun; Park, Jisook; Koh, Younsuck; Suh, Gee Young

2013-08-01

To externally validate the simplified acute physiology score 3 (SAPS3) and to customize it for use in Korean intensive care unit (ICU) patients. This is a prospective multicentre cohort study involving 22 ICUs from 15 centres throughout Korea. The study population comprised patients who were consecutively admitted to participating ICUs from 1 July 2010 to 31 January 2011. A total of 4617 patients were enrolled. ICU mortality was 14.3%, and hospital mortality was 20.6%. The patients were randomly assigned into one of two cohorts: a development (n = 2309) or validation (n = 2308) cohort. In the development cohort, the general SAPS3 had good discrimination (area under the receiver operating characteristics curve = 0.829), but poor calibration (Hosmer-Lemeshow goodness-of-fit test H = 123.06, P < 0.001, C = 118.45, P < 0.001). The Australasia SAPS3 did not improve calibration (H = 73.53, P < 0.001, C = 70.52, P < 0.001). Customization was achieved by altering the logit of the original SAPS3 equation. The new equation for Korean ICU patients was validated in the validation cohort, and demonstrated both good discrimination (area under the receiver operating characteristics curve = 0.835) and good calibration (H = 4.61, P = 0.799, C = 5.67, P = 0.684). General and regional Australasia SAPS3 admission scores showed poor calibration for use in Korean ICU patients, but the prognostic power of the SAPS3 was significantly improved by customization. Prediction models should be customized before being used to predict mortality in different regions of the world. © 2013 The Authors. Respirology © 2013 Asian Pacific Society of Respirology.

Methodological challenges of validating a clinical decision-making tool in the practice environment.

PubMed

Brennan, Caitlin W; Daly, Barbara J

2015-04-01

Validating a measurement tool intended for use in the practice environment poses challenges that may not be present when validating a tool intended solely for research purposes. The aim of this article is to describe the methodological challenges of validating a clinical decision-making tool, the Oncology Acuity Tool, which nurses use to make nurse assignment and staffing decisions prospectively each shift. Data were derived from a larger validation study, during which several methodological challenges arose. Revisions to the tool, including conducting iterative feedback cycles with end users, were necessary before the validation study was initiated. The "true" value of patient acuity is unknown, and thus, two approaches to inter-rater reliability assessment were used. Discordant perspectives existed between experts and end users. Balancing psychometric rigor with clinical relevance may be achieved through establishing research-practice partnerships, seeking active and continuous feedback with end users, and weighing traditional statistical rules of thumb with practical considerations. © The Author(s) 2014.

Social Exclusion Index-for Health Surveys (SEI-HS): a prospective nationwide study to extend and validate a multidimensional social exclusion questionnaire.

PubMed

van Bergen, Addi P L; Hoff, Stella J M; Schreurs, Hanneke; van Loon, Annelies; van Hemert, Albert M

2017-03-14

Social exclusion (SE) refers to the inability of certain groups or individuals to fully participate in society. SE is associated with socioeconomic inequalities in health, and its measurement in routine public health monitoring is considered key to designing effective health policies. In an earlier retrospective analysis we demonstrated that in all four major Dutch cities, SE could largely be measured with existing local public health monitoring data. The current prospective study is aimed at constructing and validating an extended national measure for SE that optimally employs available items. In 2012, a stratified general population sample of 258,928 Dutch adults completed a version of the Netherlands Public Health Monitor (PHM) questionnaire in which 9 items were added covering aspects of SE that were found to be missing in our previous research. Items were derived from the SCP social exclusion index, a well-constructed 15-item instrument developed by the Netherlands Institute for Social Research (SCP). The dataset was randomly divided into a development sample (N =129,464) and a validation sample (N = 129,464). Canonical correlation analysis was conducted in the development sample. The psychometric properties were studied and compared with those of the original SCP index. All analyses were then replicated in the validation sample. The analysis yielded a four dimensional index, the Social Exclusion Index for Health Surveys (SEI-HS), containing 8 SCP items and 9 PHM items. The four dimensions: "lack of social participation", "material deprivation", "lack of normative integration" and "inadequate access to basic social rights", were each measured with 3 to 6 items. The SEI-HS showed adequate internal consistency for both the general index and for two of four dimension scales. The internal structure and construct validity of the SEI-HS were satisfactory and similar to the original SCP index. Replication of the SEI-HS in the validation sample confirmed its generalisability. This study demonstrates that the SEI-HS offers epidemiologists and public health researchers a uniform, reliable, valid and efficient means of assessing social exclusion and its underlying dimensions. The study also provides valuable insights in how to develop embedded measures for public health surveillance.

Developing and validating a model to predict the success of an IHCS implementation: the Readiness for Implementation Model.

PubMed

Wen, Kuang-Yi; Gustafson, David H; Hawkins, Robert P; Brennan, Patricia F; Dinauer, Susan; Johnson, Pauley R; Siegler, Tracy

2010-01-01

To develop and validate the Readiness for Implementation Model (RIM). This model predicts a healthcare organization's potential for success in implementing an interactive health communication system (IHCS). The model consists of seven weighted factors, with each factor containing five to seven elements. Two decision-analytic approaches, self-explicated and conjoint analysis, were used to measure the weights of the RIM with a sample of 410 experts. The RIM model with weights was then validated in a prospective study of 25 IHCS implementation cases. Orthogonal main effects design was used to develop 700 conjoint-analysis profiles, which varied on seven factors. Each of the 410 experts rated the importance and desirability of the factors and their levels, as well as a set of 10 different profiles. For the prospective 25-case validation, three time-repeated measures of the RIM scores were collected for comparison with the implementation outcomes. Two of the seven factors, 'organizational motivation' and 'meeting user needs,' were found to be most important in predicting implementation readiness. No statistically significant difference was found in the predictive validity of the two approaches (self-explicated and conjoint analysis). The RIM was a better predictor for the 1-year implementation outcome than the half-year outcome. The expert sample, the order of the survey tasks, the additive model, and basing the RIM cut-off score on experience are possible limitations of the study. The RIM needs to be empirically evaluated in institutions adopting IHCS and sustaining the system in the long term.

Validation of the prognostic gene portfolio, ClinicoMolecular Triad Classification, using an independent prospective breast cancer cohort and external patient populations

PubMed Central

2014-01-01

Introduction Using genome-wide expression profiles of a prospective training cohort of breast cancer patients, ClinicoMolecular Triad Classification (CMTC) was recently developed to classify breast cancers into three clinically relevant groups to aid treatment decisions. CMTC was found to be both prognostic and predictive in a large external breast cancer cohort in that study. This study serves to validate the reproducibility of CMTC and its prognostic value using independent patient cohorts. Methods An independent internal cohort (n = 284) and a new external cohort (n = 2,181) were used to validate the association of CMTC between clinicopathological factors, 12 known gene signatures, two molecular subtype classifiers, and 19 oncogenic signalling pathway activities, and to reproduce the abilities of CMTC to predict clinical outcomes of breast cancer. In addition, we also updated the outcome data of the original training cohort (n = 147). Results The original training cohort reached a statistically significant difference (p < 0.05) in disease-free survivals between the three CMTC groups after an additional two years of follow-up (median = 55 months). The prognostic value of the triad classification was reproduced in the second independent internal cohort and the new external validation cohort. CMTC achieved even higher prognostic significance when all available patients were analyzed (n = 4,851). Oncogenic pathways Myc, E2F1, Ras and β-catenin were again implicated in the high-risk groups. Conclusions Both prospective internal cohorts and the independent external cohorts reproduced the triad classification of CMTC and its prognostic significance. CMTC is an independent prognostic predictor, and it outperformed 12 other known prognostic gene signatures, molecular subtype classifications, and all other standard prognostic clinicopathological factors. Our results support further development of CMTC portfolio into a guide for personalized breast cancer treatments. PMID:24996446

Multi-parameter Observations and Validation of Pre-earthquake Atmospheric Signals

NASA Astrophysics Data System (ADS)

Ouzounov, D.; Pulinets, S. A.; Hattori, K.; Mogi, T.; Kafatos, M.

2014-12-01

We are presenting the latest development in multi-sensors observations of short-term pre-earthquake phenomena preceding major earthquakes. We are exploring the potential of pre-seismic atmospheric and ionospheric signals to alert for large earthquakes. To achieve this, we start validating anomalous ionospheric /atmospheric signals in retrospective and prospective modes. The integrated satellite and terrestrial framework (ISTF) is our method for validation and is based on a joint analysis of several physical and environmental parameters (Satellite thermal infrared radiation (OLR), electron concentration in the ionosphere (GPS/TEC), VHF-bands radio waves, radon/ion activities, air temperature and seismicity patterns) that were found to be associated with earthquakes. The science rationale for multidisciplinary analysis is based on concept Lithosphere-Atmosphere-Ionosphere Coupling (LAIC) [Pulinets and Ouzounov, 2011], which explains the synergy of different geospace processes and anomalous variations, usually named short-term pre-earthquake anomalies. Our validation processes consist in two steps: (1) A continuous retrospective analysis preformed over two different regions with high seismicity- Taiwan and Japan for 2003-2009 The retrospective tests (100+ major earthquakes, M>5.9, Taiwan and Japan) show OLR anomalous behavior before all of these events with no false negatives. False alarm ratio for false positives is less then 25%. (2) Prospective testing using multiple parameters with potential for M5.5+ events. The initial testing shows systematic appearance of atmospheric anomalies in advance (days) to the M5.5+ events for Taiwan and Japan (Honshu and Hokkaido areas). Our initial prospective results suggest that our approach show a systematic appearance of atmospheric anomalies, one to several days prior to the largest earthquakes That feature could be further studied and tested for advancing the multi-sensors detection of pre-earthquake atmospheric signals.

Use of Telehealth for Research and Clinical Measures in Cochlear Implant Recipients: A Validation Study

ERIC Educational Resources Information Center

Hughes, Michelle L.; Goehring, Jenny L.; Baudhuin, Jacquelyn L.; Diaz, Gina R.; Sanford, Todd; Harpster, Roger; Valente, Daniel L.

2012-01-01

Purpose: The goal of this study was to compare clinical and research-based cochlear implant (CI) measures using telehealth versus traditional methods. Method: This prospective study used an ABA design (A = laboratory, B = remote site). All measures were made twice per visit for the purpose of assessing within-session variability. Twenty-nine adult…

[Advantages and limits of the surveillance of nosocomial infections from the microbiology laboratory: experience of Meaux hospital].

PubMed

Botterel, F; Faibis, F; Chevalier, C; Delisse, C; Fiacre, A; Dubois, A; Demachy, M C

2004-10-01

To estimate the incidence of nosocomial infections (NI) in our hospital and to increase healthcare professionals' awareness of hygiene, a prospective study was performed between January and December 2002 from the microbiology laboratory data. On 1334 suspicions of NI, corresponding to 1062 patients, sent to the hygiene correspondents in each medical care unit, the infection control team received 853 answers (64% of sendings) with 430 NI validated. The incidence rate of NI validated was 1.7 NI/1000 days of hospitalisation and 1.6 NI/100 inpatients. The NI were predominantly related to urinary tract (47%), bloodstream (14%), and lower respiratory tract (12%). Transmission of these informations to medical information department permitted a valorisation of additional 16,000 ISA points. This prospective study permitted to develop a network of hygiene correspondents in every medical care units. None of the medical care units was unharmed by NI but the exhaustive declaration of NI seems difficult to realise. This study permitted to point out some dysfunctionments in the management of invasive procedures and to improve these practices.

Policy and Validity Prospects for Performance-Based Assessment.

ERIC Educational Resources Information Center

Baker, Eva L.; And Others

1994-01-01

This article describes performance-based assessment as expounded by its proponents, comments on these conceptions, reviews evidence regarding the technical quality of performance-based assessment, and considers its validity under various policy options. (JDD)

Derivation and Validation of Two Decision Instruments for Selective Chest CT in Blunt Trauma: A Multicenter Prospective Observational Study (NEXUS Chest CT)

PubMed Central

Rodriguez, Robert M.; Langdorf, Mark I.; Nishijima, Daniel; Baumann, Brigitte M.; Hendey, Gregory W.; Medak, Anthony J.; Raja, Ali S.; Allen, Isabel E.; Mower, William R.

2015-01-01

Background Unnecessary diagnostic imaging leads to higher costs, longer emergency department stays, and increased patient exposure to ionizing radiation. We sought to prospectively derive and validate two decision instruments (DIs) for selective chest computed tomography (CT) in adult blunt trauma patients. Methods and Findings From September 2011 to May 2014, we prospectively enrolled blunt trauma patients over 14 y of age presenting to eight US, urban level 1 trauma centers in this observational study. During the derivation phase, physicians recorded the presence or absence of 14 clinical criteria before viewing chest imaging results. We determined injury outcomes by CT radiology readings and categorized injuries as major or minor according to an expert-panel-derived clinical classification scheme. We then employed recursive partitioning to derive two DIs: Chest CT-All maximized sensitivity for all injuries, and Chest CT-Major maximized sensitivity for only major thoracic injuries (while increasing specificity). In the validation phase, we employed similar methodology to prospectively test the performance of both DIs. We enrolled 11,477 patients—6,002 patients in the derivation phase and 5,475 patients in the validation phase. The derived Chest CT-All DI consisted of (1) abnormal chest X-ray, (2) rapid deceleration mechanism, (3) distracting injury, (4) chest wall tenderness, (5) sternal tenderness, (6) thoracic spine tenderness, and (7) scapular tenderness. The Chest CT-Major DI had the same criteria without rapid deceleration mechanism. In the validation phase, Chest CT-All had a sensitivity of 99.2% (95% CI 95.4%–100%), a specificity of 20.8% (95% CI 19.2%–22.4%), and a negative predictive value (NPV) of 99.8% (95% CI 98.9%–100%) for major injury, and a sensitivity of 95.4% (95% CI 93.6%–96.9%), a specificity of 25.5% (95% CI 23.5%–27.5%), and a NPV of 93.9% (95% CI 91.5%–95.8%) for either major or minor injury. Chest CT-Major had a sensitivity of 99.2% (95% CI 95.4%–100%), a specificity of 31.7% (95% CI 29.9%–33.5%), and a NPV of 99.9% (95% CI 99.3%–100%) for major injury and a sensitivity of 90.7% (95% CI 88.3%–92.8%), a specificity of 37.9% (95% CI 35.8%–40.1%), and a NPV of 91.8% (95% CI 89.7%–93.6%) for either major or minor injury. Regarding the limitations of our work, some clinicians may disagree with our injury classification and sensitivity thresholds for injury detection. Conclusions We prospectively derived and validated two DIs (Chest CT-All and Chest CT-Major) that identify blunt trauma patients with clinically significant thoracic injuries with high sensitivity, allowing for a safe reduction of approximately 25%–37% of unnecessary chest CTs. Trauma evaluation protocols that incorporate these DIs may decrease unnecessary costs and radiation exposure in the disproportionately young trauma population. PMID:26440607

Validated Risk Score for Predicting 6-Month Mortality in Infective Endocarditis.

PubMed

Park, Lawrence P; Chu, Vivian H; Peterson, Gail; Skoutelis, Athanasios; Lejko-Zupa, Tatjana; Bouza, Emilio; Tattevin, Pierre; Habib, Gilbert; Tan, Ren; Gonzalez, Javier; Altclas, Javier; Edathodu, Jameela; Fortes, Claudio Querido; Siciliano, Rinaldo Focaccia; Pachirat, Orathai; Kanj, Souha; Wang, Andrew

2016-04-18

Host factors and complications have been associated with higher mortality in infective endocarditis (IE). We sought to develop and validate a model of clinical characteristics to predict 6-month mortality in IE. Using a large multinational prospective registry of definite IE (International Collaboration on Endocarditis [ICE]-Prospective Cohort Study [PCS], 2000-2006, n=4049), a model to predict 6-month survival was developed by Cox proportional hazards modeling with inverse probability weighting for surgery treatment and was internally validated by the bootstrapping method. This model was externally validated in an independent prospective registry (ICE-PLUS, 2008-2012, n=1197). The 6-month mortality was 971 of 4049 (24.0%) in the ICE-PCS cohort and 342 of 1197 (28.6%) in the ICE-PLUS cohort. Surgery during the index hospitalization was performed in 48.1% and 54.0% of the cohorts, respectively. In the derivation model, variables related to host factors (age, dialysis), IE characteristics (prosthetic or nosocomial IE, causative organism, left-sided valve vegetation), and IE complications (severe heart failure, stroke, paravalvular complication, and persistent bacteremia) were independently associated with 6-month mortality, and surgery was associated with a lower risk of mortality (Harrell's C statistic 0.715). In the validation model, these variables had similar hazard ratios (Harrell's C statistic 0.682), with a similar, independent benefit of surgery (hazard ratio 0.74, 95% CI 0.62-0.89). A simplified risk model was developed by weight adjustment of these variables. Six-month mortality after IE is ≈25% and is predicted by host factors, IE characteristics, and IE complications. Surgery during the index hospitalization is associated with lower mortality but is performed less frequently in the highest risk patients. A simplified risk model may be used to identify specific risk subgroups in IE. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Multicenter comparison of two clinical decision rules for the use of radiography in acute, high-risk knee injuries.

PubMed

Seaberg, D C; Yealy, D M; Lukens, T; Auble, T; Mathias, S

1998-07-01

Two separate clinical decision rules, one developed in Ottawa and the other in Pittsburgh, for the use of radiography in acute knee injuries have been previously validated and published. In this study, the rules were prospectively validated and compared in a new set of patients. A prospective, blinded, multicenter trial was conducted in the emergency departments of three urban teaching hospitals. A convenience sample of 934 patients with knee pain requiring radiographs was enrolled. A standardized data form was completed for each patient, comprising the 10 clinical variables included in the two rules. Standard knee radiographs were then taken in each patient. The rules were interpreted by the primary investigator on the basis of the data sheet and the final radiologist radiograph reading. In the 745 patients in whom the Pittsburgh rules could be applied there were 91 fractures (12.2%). The use of the Pittsburgh rule missed one fracture, yielding a sensitivity of 99% (95% confidence interval [CI], 94% to 100%); the specificity was 60% (95% CI, 56% to 64%). The Ottawa inclusion criteria were met by 750 patients, with 87 fractures (11.6%). The Ottawa rule missed three fractures, for a sensitivity of 97% (95% CI, 90% to 99%); specificity was 27% (95% CI, 23% to 30%). Prospective validation and comparison found the Pittsburgh rule for knee radiographs to be more specific without loss of sensitivity compared with the Ottawa rule.

Analytic validation and real-time clinical application of an amplicon-based targeted gene panel for advanced cancer

PubMed Central

Wing, Michele R.; Reeser, Julie W.; Smith, Amy M.; Reeder, Matthew; Martin, Dorrelyn; Jewell, Benjamin M.; Datta, Jharna; Miya, Jharna; Monk, J. Paul; Mortazavi, Amir; Otterson, Gregory A.; Goldberg, Richard M.; VanDeusen, Jeffrey B.; Cole, Sharon; Dittmar, Kristin; Jaiswal, Sunny; Kinzie, Matthew; Waikhom, Suraj; Freud, Aharon G.; Zhou, Xiao-Ping; Chen, Wei; Bhatt, Darshna; Roychowdhury, Sameek

2017-01-01

Multiplex somatic testing has emerged as a strategy to test patients with advanced cancer. We demonstrate our analytic validation approach for a gene hotspot panel and real-time prospective clinical application for any cancer type. The TruSight Tumor 26 assay amplifies 85 somatic hotspot regions across 26 genes. Using cell line and tumor mixes, we observed that 100% of the 14,715 targeted bases had at least 1000x raw coverage. We determined the sensitivity (100%, 95% CI: 96-100%), positive predictive value (100%, 95% CI: 96-100%), reproducibility (100% concordance), and limit of detection (3% variant allele frequency at 1000x read depth) of this assay to detect single nucleotide variants and small insertions and deletions. Next, we applied the assay prospectively in a clinical tumor sequencing study to evaluate 174 patients with metastatic or advanced cancer, including frozen tumors, formalin-fixed tumors, and enriched peripheral blood mononuclear cells in hematologic cancers. We reported one or more somatic mutations in 89 (53%) of the sequenced tumors (167 passing quality filters). Forty-three of these patients (26%) had mutations that would enable eligibility for targeted therapies. This study demonstrates the validity and feasibility of applying TruSight Tumor 26 for pan-cancer testing using multiple specimen types. PMID:29100271

Comprehensive Cocurricular Support Promotes Persistence of Community College STEM Students

ERIC Educational Resources Information Center

Shadduck, Peggy

2017-01-01

Despite good career prospects in science, technology, engineering, and mathematics (STEM) fields, persistence of students in STEM fields of study at the community college and transfer to universities to pursue STEM majors is often quite low. Theories of persistence emphasize the importance of engagement, integration, validation, and financial…

Analysis of 2000 cases treated with gamma knife surgery: validating eligibility criteria for a prospective multi-institutional study of stereotactic radiosurgery alone for treatment of patients with 1-10 brain metastases (JLGK0901) in Japan

PubMed Central

Higuchi, Yoshinori; Nagano, Osamu; Sato, Yasunori; Yamamoto, Masaaki; Ono, Junichi; Saeki, Naokatsu; Miyakawa, Akifumi; Hirai, Tatsuo

2012-01-01

Objective The Japan Leksell Gamma Knife (JLGK) Society has conducted a prospective multi-institute study (JLGK0901, UNIN000001812) for selected patients in order to prove the effectiveness of stereotactic radiosurgery (SRS) alone using the gamma knife (GK) for 1-10 brain lesions. Herein, we verify the validity of 5 major patient selection criteria for the JLGK0901 trial. Materials and Methods Between 1998 and 2010, 2246 consecutive cases with 10352 brain metastases treated with GK were analyzed to determine the validity of the following 5 major JLGK0901 criteria; 1) 1-10 brain lesions, 2) less than 10 cm3 volume of the largest tumor, 3) no more than 15 cm3 total tumor volume, 4) no cerebrospinal fluid (CSF) dissemination, 5) Karnofsky performance status (KPS) score ≥70. Results For cases with >10 brain metastases, salvage treatments for new lesions were needed more frequently. The tumor control rate for lesions larger than 10 cm3 was significantly lower than that of tumors <10 cm3. Overall, neurological and qualitative survivals (OS, NS, QS) of cases with >15 cm3 total tumor volume or positive magnetic resonance imaging findings of CSF were significantly poorer. Outcomes in cases with KPS <70 were significantly poorer in terms of OS. Conclusion Our retrospective results of 2246 GK-treated cases verified the validity of the 5 major JLGK0901 criteria. The inclusion criteria for the JLGK0901 study are appearently good indications for SRS. PMID:29296339

Development of an Instrument to Assess Prospective Elementary Teacher Self-Efficacy Beliefs about Equitable Science Teaching and Learning (SEBEST)

NASA Astrophysics Data System (ADS)

Ritter, Jennifer M.; Boone, William J.; Rubba, Peter A.

2001-06-01

This paper presents an overview of the procedures used to develop and validate an instrument to measure the self-efficacy beliefs of prospective elementary teachers about equitable science teaching and learning. The instrument, titled the SEBEST, was based on the work of Ashton and Webb (1986a, 1986b) and Bandura (1977, 1986). It was modeled after the Science Teaching Efficacy Belief Instrument (STEBI) (Riggs, 1988) and the Science Teaching Efficacy Belief Instrument for Prospective Teachers (STEBI-B) (Enochs & Riggs, 1990). Based on the standardized development procedures used and associated evidence, the SEBEST appears to be a content and construct valid instrument, with high internal reliability qualities. "Most probable response" plots are introduced and used to bring meaning to SEBEST raw scores.

The Amsterdam wrist rules: the multicenter prospective derivation and external validation of a clinical decision rule for the use of radiography in acute wrist trauma.

PubMed

Walenkamp, Monique M J; Bentohami, Abdelali; Slaar, Annelie; Beerekamp, M Suzan H; Maas, Mario; Jager, L Cara; Sosef, Nico L; van Velde, Romuald; Ultee, Jan M; Steyerberg, Ewout W; Goslings, J Carel; Schep, Niels W L

2015-12-18

Although only 39 % of patients with wrist trauma have sustained a fracture, the majority of patients is routinely referred for radiography. The purpose of this study was to derive and externally validate a clinical decision rule that selects patients with acute wrist trauma in the Emergency Department (ED) for radiography. This multicenter prospective study consisted of three components: (1) derivation of a clinical prediction model for detecting wrist fractures in patients following wrist trauma; (2) external validation of this model; and (3) design of a clinical decision rule. The study was conducted in the EDs of five Dutch hospitals: one academic hospital (derivation cohort) and four regional hospitals (external validation cohort). We included all adult patients with acute wrist trauma. The main outcome was fracture of the wrist (distal radius, distal ulna or carpal bones) diagnosed on conventional X-rays. A total of 882 patients were analyzed; 487 in the derivation cohort and 395 in the validation cohort. We derived a clinical prediction model with eight variables: age; sex, swelling of the wrist; swelling of the anatomical snuffbox, visible deformation; distal radius tender to palpation; pain on radial deviation and painful axial compression of the thumb. The Area Under the Curve at external validation of this model was 0.81 (95 % CI: 0.77-0.85). The sensitivity and specificity of the Amsterdam Wrist Rules (AWR) in the external validation cohort were 98 % (95 % CI: 95-99 %) and 21 % (95 % CI: 15 %-28). The negative predictive value was 90 % (95 % CI: 81-99 %). The Amsterdam Wrist Rules is a clinical prediction rule with a high sensitivity and negative predictive value for fractures of the wrist. Although external validation showed low specificity and 100 % sensitivity could not be achieved, the Amsterdam Wrist Rules can provide physicians in the Emergency Department with a useful screening tool to select patients with acute wrist trauma for radiography. The upcoming implementation study will further reveal the impact of the Amsterdam Wrist Rules on the anticipated reduction of X-rays requested, missed fractures, Emergency Department waiting times and health care costs. This study was registered in the Dutch Trial Registry, reference number NTR2544 on October 1(st), 2010.

Validity of a PCR assay in CSF for the diagnosis of neurocysticercosis

PubMed Central

Campoverde, Alfredo; Romo, Matthew L.; García, Lorena; Piedra, Luis M.; Pacurucu, Mónica; López, Nelson; Aguilar, Jenner; López, Sebastian; Vintimilla, Luis C.; Toral, Ana M.; Peña-Tapia, Pablo

2017-01-01

Objective: To prospectively evaluate the validity of a PCR assay in CSF for the diagnosis of neurocysticercosis (NC). Methods: We conducted a multicenter, prospective case-control study, recruiting participants from 5 hospitals in Cuenca, Ecuador, from January 2015 to February 2016. Cases fulfilled validated diagnostic criteria for NC. For each case, a neurosurgical patient who did not fulfill the diagnostic criteria for NC was selected as a control. CT and MRI, as well as a CSF sample, were collected from both cases and controls. The diagnostic criteria to identify cases were used as a reference standard. Results: Overall, 36 case and 36 control participants were enrolled. PCR had a sensitivity of 72.2% (95% confidence interval [CI] 54.8%–85.8%) and a specificity of 100.0% (95% CI 90.3%–100.0%). For parenchymal NC, PCR had a sensitivity of 42.9% (95% CI 17.7%–71.1%), and for extraparenchymal NC, PCR had a sensitivity of 90.9% (95% CI 70.8%–98.9%). Conclusions: This study demonstrated the usefulness of this PCR assay in CSF for the diagnosis of NC. PCR may be particularly helpful for diagnosing extraparenchymal NC when neuroimaging techniques have failed. Classification of evidence: This study provides Class III evidence that CSF PCR can accurately identify patients with extraparenchymal NC. PMID:28105460

Validation of the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI or Niv score): a multicenter prospective study.

PubMed

Niv, Y; Ilani, S; Levi, Z; Hershkowitz, M; Niv, E; Fireman, Z; O'Donnel, S; O'Morain, C; Eliakim, R; Scapa, E; Kalantzis, N; Kalantzis, C; Apostolopoulos, P; Gal, E

2012-01-01

The Capsule Endoscopy Crohn's Disease Activity Index (CECDAI or Niv score) was devised to measure mucosal disease activity using video capsule endoscopy (VCE). The aim of the current study was to prospectively validate the use of the scoring system in daily practice. This was a multicenter, double-blind, prospective, controlled study of VCE videos from 62 consecutive patients with isolated small-bowel Crohn's disease. The CECDAI was designed to evaluate three main parameters of Crohn's disease: inflammation (A), extent of disease (B), and stricture (C), in both the proximal and distal segments of the small bowel. The final score was calculated by adding the two segmental scores: CECDAI = ([A1 × B1] + C1) + ([A2 × B2] + C2). Each examiner in every site interpreted 6 - 10 videos and calculated the CECDAI. The de-identified CD-ROMs were then coded and sent to the principal investigator for CECDAI calculation. The cecum was reached in 72 % and 86 % of examinations, and proximal small-bowel involvement was found in 56 % and 62 % of the patients, according to the site investigators and principal investigator, respectively. Significant correlation was demonstrated between the calculation of the CECDAI by the individual site investigators and that performed by the principal investigator. Overall correlation between endoscopists from the different study centers was good, with r = 0.767 (range 0.717 - 0.985; Kappa 0.66; P < 0.001). There was no correlation between the CECDAI and the Crohn's Disease Activity Index or the Inflammatory Bowel Disease Quality of Life Questionnaire or any of their components. A new scoring system of mucosal injury in Crohn's disease of the small intestine, the CECDAI, was validated. Its use in controlled trials and/or regular follow-up of these patients is advocated. © Georg Thieme Verlag KG Stuttgart · New York.

Using the Female Sexual Function Index (FSFI) to evaluate sexual function in women with genital mutilation undergoing surgical reconstruction: a pilot prospective study.

PubMed

Vital, Mathilde; de Visme, Sophie; Hanf, Matthieu; Philippe, Henri-Jean; Winer, Norbert; Wylomanski, Sophie

2016-07-01

Few prospective studies have evaluated sexual function in women with female genital mutilation by cutting (FGM/C) before and after clitoral reconstructive surgery, and none used a validated questionnaire. A validated questionnaire, the Female Sexual Function Index (FSFI) was used for the first time, to assess the impact of reconstructive surgery on sexual function in women with female genital mutilation/cutting (FGM/C) before and after clitoral reconstructive surgery. Women with FGM/C consulting at the Nantes University Hospital for clitoral reconstruction between 2013 and 2014 were prospectively included. All patients completed a questionnaire at inclusion, describing their social, demographic, and FGM/C characteristics. They were also asked to complete the FSFI as well as a questionnaire about clitoral sensations, symptoms of depression or anxiety, and self-esteem before and 3 and 6 months after the surgery. Paired Wilcoxon and McNemar tests were used to compare data. Of the 12 women included, 9 (75%) had type II mutilations. Results showed a global sexual dysfunction (median FSFI summary score=17) before surgery. Clitoral sensations were absent in 8 women (67%). Six months after surgery, all FSFI dimensions except lubrication had improved significantly (median FSFI summary score=29, P=0.009). Ten women had clitoral sensations, and 11 (92%) were satisfied with their surgery. This study shows that 6 months after clitoral reconstructive surgery, women reported a multidimensional positive improvement in their sexual function. The FSFI is a promising tool for routine standardized assessment of the sexual function of women with FGM/C for determining appropriate management and assessing it. Larger studies with validated questionnaires assessing self-esteem, depression, and body image are also needed to develop an integrative approach and to provide evidence-based recommendations about management of these women. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Validation of intermediate end points in cancer research.

PubMed

Schatzkin, A; Freedman, L S; Schiffman, M H; Dawsey, S M

1990-11-21

Investigations using intermediate end points as cancer surrogates are quicker, smaller, and less expensive than studies that use malignancy as the end point. We present a strategy for determining whether a given biomarker is a valid intermediate end point between an exposure and incidence of cancer. Candidate intermediate end points may be selected from case series, ecologic studies, and animal experiments. Prospective cohort and sometimes case-control studies may be used to quantify the intermediate end point-cancer association. The most appropriate measure of this association is the attributable proportion. The intermediate end point is a valid cancer surrogate if the attributable proportion is close to 1.0, but not if it is close to 0. Usually, the attributable proportion is close to neither 1.0 nor 0; in this case, valid surrogacy requires that the intermediate end point mediate an established exposure-cancer relation. This would in turn imply that the exposure effect would vanish if adjusted for the intermediate end point. We discuss the relative advantages of intervention and observational studies for the validation of intermediate end points. This validation strategy also may be applied to intermediate end points for adverse reproductive outcomes and chronic diseases other than cancer.

A critical evaluation of the validity of episodic future thinking: A clinical neuropsychology perspective.

PubMed

Ward, Amanda M

2016-11-01

Episodic future thinking is defined as the ability to mentally simulate a future event. Although episodic future thinking has been studied extensively in neuroscience, this construct has not been explored in depth from the perspective of clinical neuropsychology. The aim of this critical narrative review is to assess the validity and clinical implications of episodic future thinking. A systematic review of episodic future thinking literature was conducted. PubMed and PsycInfo were searched through July 2015 for review and empirical articles with the following search terms: "episodic future thinking," "future mental simulation," "imagining the future," "imagining new experiences," "future mental time travel," "future autobiographical experience," and "prospection." The review discusses evidence that episodic future thinking is important for adaptive functioning, which has implications for neurological populations. To determine the validity of episodic future thinking, the construct is evaluated with respect to related constructs, such as imagination, episodic memory, autobiographical memory, prospective memory, narrative construction, and working memory. Although it has been minimally investigated, there is evidence of convergent and discriminant validity for episodic future thinking. Research has not addressed the incremental validity of episodic future thinking. Practical considerations of episodic future thinking tasks and related constructs in a clinical neuropsychological setting are considered. The utility of episodic future thinking is currently unknown due to the lack of research investigating the validity of episodic future thinking. Future work is discussed, which could determine whether episodic future thinking is an important missing piece in standard clinical neuropsychological assessment. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Multicenter Prospective Study of Angiogenesis Polymorphism Validation in HCC Patients Treated with Sorafenib. An INNOVATE Study Protocol.

PubMed

Casadei Gardini, Andrea; Faloppi, Luca; Aprile, Giuseppe; Brunetti, Oronzo; Caparello, Chiara; Corbelli, Jody; Chessa, Luchino; Bruno, Daniele; Ercolani, Giorgio; Leonetti, Alessandro; de Stefano, Giorgio; Farella, Nunzia; Foschi, Francesco Giuseppe; Lanzi, Arianna; Dadduzio, Vincenzo; Marisi, Giorgia; Masi, Gianluca; Negri, Francesca V; Pagan, Flavia; Santini, Daniele; Scarpi, Emanuela; Silletta, Marianna; Silvestris, Nicola; Tamburini, Emiliano; Tassinari, Davide; Vivaldi, Caterina; Gentilucci, Umberto Vespasiani; Zagonel, Vittorina; Calvetti, Lorenzo; Cascinu, Stefano; Frassineti, Giovanni Luca; Scartozzi, Mario

2017-12-01

Introduction Although sorafenib is the upfront standard of care for advanced hepatocellular carcinoma (HCC), molecular predictors of efficacy have not been identified yet. In the ALICE-1 study, rs2010963 of VEGF-A and VEGF-C proved to be independent predictive factors for progression-free survival (PFS) and overall survival (OS) in multivariate analysis. The ALICE-1 study results were confirmed in the ALICE-2 study, in which VEGF and VEGFR SNPs were analyzed. In the ePHAS study we analyzed the SNPs of eNOS. In univariate analysis, patients homozygous for an eNOS haplotype (HT1: T-4b at eNOS-786/eNOS VNTR) had significantly shorter median PFS and OS than those with other haplotypes. These data were confirmed in the validation set. Methods This nonpharmacological, interventional, prospective multicenter study aims to determine whether eNOS, HIF-1, VEGF, Ang2 and VEGFR polymorphisms play a role in predicting the objective response rate, PFS, and OS of advanced HCC patients treated with sorafenib. The study will involve 160 advanced HCC patients with Child-Pugh class A disease. The primary aim is to validate the prognostic or predictive roles of eNOS, Ang2, HIF-1, VEGF and VEGFR polymorphisms in relation to the clinical outcome (PFS) of HCC patients treated with sorafenib. Conclusions Overall, our data may suggest that polymorphism analysis of the VEGF, VEGFR-2, HIF and eNOS genes can identify HCC patients who are more likely to benefit from sorafenib.

Development, reproducibility and validity of the food frequency questionnaire in the Poland arm of the Prospective Urban and Rural Epidemiological (PURE) study.

PubMed

Dehghan, M; Ilow, R; Zatonska, K; Szuba, A; Zhang, X; Mente, A; Regulska-Ilow, B

2012-06-01

A food frequency questionnaire (FFQ) is the most commonly used method in large epidemiological studies. The validation of an FFQ is essential for specific populations because foods are culture-dependent. The present study aimed to develop an FFQ and evaluate its validity and reproducibility in estimating the intake of nutrients in urban and rural areas of Poland. Adult participants (n = 146) in the Polish arm of the ongoing Prospective Urban and Rural Epidemiological (PURE) study completed FFQs on two occasions, as well as four 24-h dietary recalls (DRs) during a 12-month period. Correlation coefficients (r) and de-attenuated correlation coefficients between dietary recalls and both FFQs were calculated for selected macro- and micronutrients. Agreement between the two methods was evaluated by classification into quartiles and the Bland-Altman method. Reproducibility was assessed by the intra-class correlation coefficient (ICC). The final food list contained 134 food items. For urban participants, FFQ2 generally underestimated energy, protein and fat compared to the FFQ1 and mean of DRs. In rural areas, compared to DRs, both FFQs overestimated energy and macronutrients. For both urban and rural settings, de-attenuated correlation exceeded 0.4 for almost all nutrients and the exact agreement in quartile categorisation was >66%. When assessing repeatability, ICC varied from 0.39-0.63 in an urban setting and 0.19-0.45 in a rural setting. This 134-item FFQ has good validity and reproducibility in relation to the reference method and can be used to rank individuals based on their macro- and micronutrient intake. © 2012 The Authors. Journal of Human Nutrition and Dietetics © 2012 The British Dietetic Association Ltd.

Prospective Validation of Modified NEXUS Cervical Spine Injury Criteria in Low-risk Elderly Fall Patients

PubMed Central

Tran, John; Jeanmonod, Donald; Agresti, Darin; Hamden, Khalief; Jeanmonod, Rebecca K.

2016-01-01

Introduction The National Emergency X-radiography Utilization Study (NEXUS) criteria are used extensively in emergency departments to rule out C-spine injuries (CSI) in the general population. Although the NEXUS validation set included 2,943 elderly patients, multiple case reports and the Canadian C-Spine Rules question the validity of applying NEXUS to geriatric populations. The objective of this study was to validate a modified NEXUS criteria in a low-risk elderly fall population with two changes: a modified definition for distracting injury and the definition of normal mentation. Methods This is a prospective, observational cohort study of geriatric fall patients who presented to a Level I trauma center and were not triaged to the trauma bay. Providers enrolled non-intoxicated patients at baseline mental status with no lateralizing neurologic deficits. They recorded midline neck tenderness, signs of trauma, and presence of other distracting injury. Results We enrolled 800 patients. One patient fall event was excluded due to duplicate enrollment, and four were lost to follow up, leaving 795 for analysis. Average age was 83.6 (range 65–101). The numbers in parenthesis after the negative predictive value represent confidence interval. There were 11 (1.4%) cervical spine injuries. One hundred seventeen patients had midline tenderness and seven of these had CSI; 366 patients had signs of trauma to the face/neck, and 10 of these patients had CSI. Using signs of trauma to the head/neck as the only distracting injury and baseline mental status as normal alertness, the modified NEXUS criteria was 100% sensitive (CI [67.9–100]) with a negative predictive value of 100 (98.7–100). Conclusion Our study suggests that a modified NEXUS criteria can be safely applied to low-risk elderly falls. PMID:27330655

Prospective Validation of Modified NEXUS Cervical Spine Injury Criteria in Low-risk Elderly Fall Patients.

PubMed

Tran, John; Jeanmonod, Donald; Agresti, Darin; Hamden, Khalief; Jeanmonod, Rebecca K

2016-05-01

The National Emergency X-radiography Utilization Study (NEXUS) criteria are used extensively in emergency departments to rule out C-spine injuries (CSI) in the general population. Although the NEXUS validation set included 2,943 elderly patients, multiple case reports and the Canadian C-Spine Rules question the validity of applying NEXUS to geriatric populations. The objective of this study was to validate a modified NEXUS criteria in a low-risk elderly fall population with two changes: a modified definition for distracting injury and the definition of normal mentation. This is a prospective, observational cohort study of geriatric fall patients who presented to a Level I trauma center and were not triaged to the trauma bay. Providers enrolled non-intoxicated patients at baseline mental status with no lateralizing neurologic deficits. They recorded midline neck tenderness, signs of trauma, and presence of other distracting injury. We enrolled 800 patients. One patient fall event was excluded due to duplicate enrollment, and four were lost to follow up, leaving 795 for analysis. Average age was 83.6 (range 65-101). The numbers in parenthesis after the negative predictive value represent confidence interval. There were 11 (1.4%) cervical spine injuries. One hundred seventeen patients had midline tenderness and seven of these had CSI; 366 patients had signs of trauma to the face/neck, and 10 of these patients had CSI. Using signs of trauma to the head/neck as the only distracting injury and baseline mental status as normal alertness, the modified NEXUS criteria was 100% sensitive (CI [67.9-100]) with a negative predictive value of 100 (98.7-100). Our study suggests that a modified NEXUS criteria can be safely applied to low-risk elderly falls.

Children's mental time travel during mind wandering.

PubMed

Ye, Qun; Song, Xiaolan; Zhang, Yi; Wang, Qinqin

2014-01-01

The prospective bias is a salient feature of mind wandering in healthy adults, yet little is known about the temporal focus of children's mind wandering. In the present study, (I) we developed the temporal focus of mind wandering questionnaire for school-age children (TFMWQ-C), a 12-item scale with good test-retest reliability and construct validity. (II) The criterion validity was tested by thought sampling in both choice reaction time task and working memory task. A positive correlation was found between the temporal focus measured by the questionnaire and the one adopted during task-unrelated thoughts (TUTs) by thought sampling probes, especially in the trait level of future-oriented mind wandering. At the same time, children who experienced more TUTs tended to show worse behavioral performance during tasks. (III) The children in both tasks experienced more future-oriented TUTs than past-oriented ones, which was congruent with the results observed in adults; however, in contrast with previous research on adults, the prospective bias was not influenced by task demands. Together these results indicate that the prospective bias of mind wandering has emerged since the school-age (9∼13 years old), and that the relationship between mental time travel (MTT) during mind wandering and the use of cognitive resources differs between children and adults. Our study provides new insights into how this interesting feature of mind wandering may adaptively contribute to the development of children's MTT.

GIS prospectivity mapping and 3D modeling validation for potential uranium deposit targets in Shangnan district, China

NASA Astrophysics Data System (ADS)

Xie, Jiayu; Wang, Gongwen; Sha, Yazhou; Liu, Jiajun; Wen, Botao; Nie, Ming; Zhang, Shuai

2017-04-01

Integrating multi-source geoscience information (such as geology, geophysics, geochemistry, and remote sensing) using GIS mapping is one of the key topics and frontiers in quantitative geosciences for mineral exploration. GIS prospective mapping and three-dimensional (3D) modeling can be used not only to extract exploration criteria and delineate metallogenetic targets but also to provide important information for the quantitative assessment of mineral resources. This paper uses the Shangnan district of Shaanxi province (China) as a case study area. GIS mapping and potential granite-hydrothermal uranium targeting were conducted in the study area combining weights of evidence (WofE) and concentration-area (C-A) fractal methods with multi-source geoscience information. 3D deposit-scale modeling using GOCAD software was performed to validate the shapes and features of the potential targets at the subsurface. The research results show that: (1) the known deposits have potential zones at depth, and the 3D geological models can delineate surface or subsurface ore-forming features, which can be used to analyze the uncertainty of the shape and feature of prospectivity mapping at the subsurface; (2) single geochemistry anomalies or remote sensing anomalies at the surface require combining the depth exploration criteria of geophysics to identify potential targets; and (3) the single or sparse exploration criteria zone with few mineralization spots at the surface has high uncertainty in terms of the exploration target.

External validation of preexisting first trimester preeclampsia prediction models.

PubMed

Allen, Rebecca E; Zamora, Javier; Arroyo-Manzano, David; Velauthar, Luxmilar; Allotey, John; Thangaratinam, Shakila; Aquilina, Joseph

2017-10-01

To validate the increasing number of prognostic models being developed for preeclampsia using our own prospective study. A systematic review of literature that assessed biomarkers, uterine artery Doppler and maternal characteristics in the first trimester for the prediction of preeclampsia was performed and models selected based on predefined criteria. Validation was performed by applying the regression coefficients that were published in the different derivation studies to our cohort. We assessed the models discrimination ability and calibration. Twenty models were identified for validation. The discrimination ability observed in derivation studies (Area Under the Curves) ranged from 0.70 to 0.96 when these models were validated against the validation cohort, these AUC varied importantly, ranging from 0.504 to 0.833. Comparing Area Under the Curves obtained in the derivation study to those in the validation cohort we found statistically significant differences in several studies. There currently isn't a definitive prediction model with adequate ability to discriminate for preeclampsia, which performs as well when applied to a different population and can differentiate well between the highest and lowest risk groups within the tested population. The pre-existing large number of models limits the value of further model development and future research should be focussed on further attempts to validate existing models and assessing whether implementation of these improves patient care. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

Validation of the Modified Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE) Questionnaire: A Prospective Analysis of Facial Plastic and Reconstructive Surgery Procedures.

PubMed

Oliver, Jeremie D; Menapace, Deanna; Younes, Ahmed; Recker, Chelsey; Hamilton, Grant; Friedman, Oren

2018-02-01

Although periorbital edema and ecchymosis are commonly encountered after facial plastic and reconstructive surgery procedures, there is currently no validated grading scale to qualify these findings. In this study, the modified "Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE)" questionnaire is used as a grading scale for patients undergoing facial plastic surgery procedures. This article aims to validate a uniform grading scale for periorbital edema and ecchymosis using the modified SPREE questionnaire in the postoperative period. This is a prospective study including 82 patients at two different routine postoperative visits (second and seventh postoperative days), wherein the staff and resident physicians, physician assistants (PAs), patients, and any accompanying adults were asked to use the modified SPREE questionnaire to score edema and ecchymosis of each eye of the patient who had undergone a plastic surgery procedure. Interrater and intrarater agreements were then examined. Cohen's kappa coefficient was calculated to measure intrarater and interrater agreement between health care professionals (staff physicians and resident physicians); staff physicians and PAs; and staff physicians, patients, and accompanying adults. Good to excellent agreement was identified between staff physicians and resident physicians as well as between staff physicians and PAs. There was, however, poor agreement between staff physicians, patients, and accompanying adults. In addition, excellent agreement was found for intraobserver reliability during same-day visits. The modified SPREE questionnaire is a validated grading system for use by health care professionals to reliably rate periorbital edema and ecchymosis in the postoperative period. Validation of the modified SPREE questionnaire may improve ubiquity in medical literature reporting and related outcomes reporting in future. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Characteristics of a multisensor system for non invasive glucose monitoring with external validation and prospective evaluation.

PubMed

Caduff, Andreas; Mueller, Martin; Megej, Alexander; Dewarrat, Francois; Suri, Roland E; Klisic, Jelena; Donath, Marc; Zakharov, Pavel; Schaub, Dominik; Stahel, Werner A; Talary, Mark S

2011-05-15

The Multisensor Glucose Monitoring System (MGMS) features non invasive sensors for dielectric characterisation of the skin and underlying tissue in a wide frequency range (1 kHz-100 MHz, 1 and 2 GHz) as well as optical characterisation. In this paper we describe the results of using an MGMS in a miniaturised housing with fully integrated sensors and battery. Six patients with Type I Diabetes Mellitus (age 44±16 y; BMI 24.1±1.3 kg/m(2), duration of diabetes 27±12 y; HbA1c 7.3±1.0%) wore a single Multisensor at the upper arm position and performed a total of 45 in-clinic study days with 7 study days per patient on average (min. 5 and max. 10). Glucose changes were induced either orally or by i.v. glucose administration and the blood glucose was measured routinely. Several prospective data evaluation routines were applied to evaluate the data. The results are shown using one of the restrictive data evaluation routines, where measurements from the first 22 study days were used to train a linear regression model. The global model was then prospectively applied to the data of the remaining 23 study days to allow for an external validation of glucose prediction. The model application yielded a Mean Absolute Relative Difference of 40.8%, a Mean Absolute Difference of 51.9 mg dL(-1), and a correlation of 0.84 on average per study day. The Clarke error grid analyses showed 89.0% in A+B, 4.5% in C, 4.6% in D and 1.9% in the E region. Prospective application of a global, purely statistical model, demonstrates that glucose variations can be tracked non invasively by the MGMS in most cases under these conditions. Copyright © 2011 Elsevier B.V. All rights reserved.

Physical activity, sedentary behavior and risk of hypertensive disorders of pregnancy in Hispanic women.

PubMed

Chasan-Taber, Lisa; Silveira, Marushka; Pekow, Penelope; Braun, Barry; Manson, JoAnn E; Solomon, Caren G; Markenson, Glenn

2015-02-01

Prior studies of the association between physical activity and hypertensive disorders of pregnancy have been conflicting; the majority focused on leisure-time activity only, did not use physical activity questionnaires validated for pregnancy, and were conducted in primarily non-Hispanic white populations. We prospectively evaluated this association among 1240 Hispanic women in Proyecto Buena Salud. The Pregnancy Physical Activity Questionnaire, validated for use in pregnancy, was used to assess pre- and early pregnancy sports/exercise, household/caregiving, occupational and transportation activity. Diagnoses of hypertensive disorders of pregnancy were based on medical record abstraction and confirmed by the study obstetrician. A total of 49 women (4.0%) were diagnosed with a hypertensive disorder of pregnancy, including 32 women (2.6%) with pre-eclampsia. In age-adjusted analyses, high levels of early pregnancy household/caregiving activity were associated with reduced risk of total hypertensive disorders (OR = 0.4, 95% CI 0.1-0.9) and pre-eclampsia (OR = 0.3, 95% CI 0.1-0.9) relative to low levels; however, these findings were no longer statistically significant in multivariable models. Pre-pregnancy activity and pattern of activity from pre- to early-pregnancy were not significantly associated with risk. Finally, sedentary behavior was not significantly associated with hypertensive disorders. Findings from this prospective study of Hispanic women were consistent with those of prior prospective cohorts indicating that physical activity prior to and during early pregnancy does not significantly reduce risk of hypertensive disorders of pregnancy.

Real-time web-based assessment of total population risk of future emergency department utilization: statewide prospective active case finding study.

PubMed

Hu, Zhongkai; Jin, Bo; Shin, Andrew Y; Zhu, Chunqing; Zhao, Yifan; Hao, Shiying; Zheng, Le; Fu, Changlin; Wen, Qiaojun; Ji, Jun; Li, Zhen; Wang, Yong; Zheng, Xiaolin; Dai, Dorothy; Culver, Devore S; Alfreds, Shaun T; Rogow, Todd; Stearns, Frank; Sylvester, Karl G; Widen, Eric; Ling, Xuefeng B

2015-01-13

An easily accessible real-time Web-based utility to assess patient risks of future emergency department (ED) visits can help the health care provider guide the allocation of resources to better manage higher-risk patient populations and thereby reduce unnecessary use of EDs. Our main objective was to develop a Health Information Exchange-based, next 6-month ED risk surveillance system in the state of Maine. Data on electronic medical record (EMR) encounters integrated by HealthInfoNet (HIN), Maine's Health Information Exchange, were used to develop the Web-based surveillance system for a population ED future 6-month risk prediction. To model, a retrospective cohort of 829,641 patients with comprehensive clinical histories from January 1 to December 31, 2012 was used for training and then tested with a prospective cohort of 875,979 patients from July 1, 2012, to June 30, 2013. The multivariate statistical analysis identified 101 variables predictive of future defined 6-month risk of ED visit: 4 age groups, history of 8 different encounter types, history of 17 primary and 8 secondary diagnoses, 8 specific chronic diseases, 28 laboratory test results, history of 3 radiographic tests, and history of 25 outpatient prescription medications. The c-statistics for the retrospective and prospective cohorts were 0.739 and 0.732 respectively. Integration of our method into the HIN secure statewide data system in real time prospectively validated its performance. Cluster analysis in both the retrospective and prospective analyses revealed discrete subpopulations of high-risk patients, grouped around multiple "anchoring" demographics and chronic conditions. With the Web-based population risk-monitoring enterprise dashboards, the effectiveness of the active case finding algorithm has been validated by clinicians and caregivers in Maine. The active case finding model and associated real-time Web-based app were designed to track the evolving nature of total population risk, in a longitudinal manner, for ED visits across all payers, all diseases, and all age groups. Therefore, providers can implement targeted care management strategies to the patient subgroups with similar patterns of clinical histories, driving the delivery of more efficient and effective health care interventions. To the best of our knowledge, this prospectively validated EMR-based, Web-based tool is the first one to allow real-time total population risk assessment for statewide ED visits.

Model-based clinical dose optimization for phenobarbital in neonates: An illustration of the importance of data sharing and external validation.

PubMed

Völler, Swantje; Flint, Robert B; Stolk, Leo M; Degraeuwe, Pieter L J; Simons, Sinno H P; Pokorna, Paula; Burger, David M; de Groot, Ronald; Tibboel, Dick; Knibbe, Catherijne A J

2017-11-15

Particularly in the pediatric clinical pharmacology field, data-sharing offers the possibility of making the most of all available data. In this study, we utilize previously collected therapeutic drug monitoring (TDM) data of term and preterm newborns to develop a population pharmacokinetic model for phenobarbital. We externally validate the model using prospective phenobarbital data from an ongoing pharmacokinetic study in preterm neonates. TDM data from 53 neonates (gestational age (GA): 37 (24-42) weeks, bodyweight: 2.7 (0.45-4.5) kg; postnatal age (PNA): 4.5 (0-22) days) contained information on dosage histories, concentration and covariate data (including birth weight, actual weight, post-natal age (PNA), postmenstrual age, GA, sex, liver and kidney function, APGAR-score). Model development was carried out using NONMEM ® 7.3. After assessment of model fit, the model was validated using data of 17 neonates included in the DINO (Drug dosage Improvement in NeOnates)-study. Modelling of 229 plasma concentrations, ranging from 3.2 to 75.2mg/L, resulted in a one compartment model for phenobarbital. Clearance (CL) and volume (V d ) for a child with a birthweight of 2.6kg at PNA day 4.5 was 0.0091L/h (9%) and 2.38L (5%), respectively. Birthweight and PNA were the best predictors for CL maturation, increasing CL by 36.7% per kg birthweight and 5.3% per postnatal day of living, respectively. The best predictor for the increase in V d was actual bodyweight (0.31L/kg). External validation showed that the model can adequately predict the pharmacokinetics in a prospective study. Data-sharing can help to successfully develop and validate population pharmacokinetic models in neonates. From the results it seems that both PNA and bodyweight are required to guide dosing of phenobarbital in term and preterm neonates. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

External validation of prognostic models to predict risk of gestational diabetes mellitus in one Dutch cohort: prospective multicentre cohort study.

PubMed

Lamain-de Ruiter, Marije; Kwee, Anneke; Naaktgeboren, Christiana A; de Groot, Inge; Evers, Inge M; Groenendaal, Floris; Hering, Yolanda R; Huisjes, Anjoke J M; Kirpestein, Cornel; Monincx, Wilma M; Siljee, Jacqueline E; Van 't Zelfde, Annewil; van Oirschot, Charlotte M; Vankan-Buitelaar, Simone A; Vonk, Mariska A A W; Wiegers, Therese A; Zwart, Joost J; Franx, Arie; Moons, Karel G M; Koster, Maria P H

2016-08-30

 To perform an external validation and direct comparison of published prognostic models for early prediction of the risk of gestational diabetes mellitus, including predictors applicable in the first trimester of pregnancy.  External validation of all published prognostic models in large scale, prospective, multicentre cohort study.  31 independent midwifery practices and six hospitals in the Netherlands.  Women recruited in their first trimester (<14 weeks) of pregnancy between December 2012 and January 2014, at their initial prenatal visit. Women with pre-existing diabetes mellitus of any type were excluded.  Discrimination of the prognostic models was assessed by the C statistic, and calibration assessed by calibration plots.  3723 women were included for analysis, of whom 181 (4.9%) developed gestational diabetes mellitus in pregnancy. 12 prognostic models for the disorder could be validated in the cohort. C statistics ranged from 0.67 to 0.78. Calibration plots showed that eight of the 12 models were well calibrated. The four models with the highest C statistics included almost all of the following predictors: maternal age, maternal body mass index, history of gestational diabetes mellitus, ethnicity, and family history of diabetes. Prognostic models had a similar performance in a subgroup of nulliparous women only. Decision curve analysis showed that the use of these four models always had a positive net benefit.  In this external validation study, most of the published prognostic models for gestational diabetes mellitus show acceptable discrimination and calibration. The four models with the highest discriminative abilities in this study cohort, which also perform well in a subgroup of nulliparous women, are easy models to apply in clinical practice and therefore deserve further evaluation regarding their clinical impact. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Development and Validation of a Gender Ideology Scale for Family Planning Services in Rural China

PubMed Central

Yang, Xueyan; Li, Shuzhuo; Feldman, Marcus W.

2013-01-01

The objectives of this study are to develop a scale of gender role ideology appropriate for assessing Quality of Care in family planning services for rural China. Literature review, focus-group discussions and in-depth interviews with service providers and clients from two counties in eastern and western China, as well as experts’ assessments, were used to develop a scale for family planning services. Psychometric methodologies were applied to samples of 601 service clients and 541 service providers from a survey in a district in central China to validate its internal consistency, reliability, and construct validity with realistic and strategic dimensions. This scale is found to be reliable and valid, and has prospects for application both academically and practically in the field. PMID:23573222

[Validity 'and Utilities' clinic of a grid observation (PACSLAC-F) to evaluate the pain in seniors with dementia's living in the Long-Term Care ].

PubMed

Aubin, Michèle; Verreault, René; Savoie, Maryse; LeMay, Sylvie; Hadjistavropoulos, Thomas; Fillion, Lise; Beaulieu, Marie; Viens, Chantal; Bergeron, Rénald; Vézina, Lucie; Misson, Lucie; Fuchs-Lacelle, Shannon

2008-01-01

This study presents the validation of the French Canadian version (PACLSAC-F) of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC). Unlike the published validation of the English version of the PACSLAC, which was validated retrospectively, the French version was validated prospectively. The PACSLAC-F was completed by nurses working in long-term care facilities after observing 86 seniors, with severe cognitive impairment, in calm, painful or distressing but non-painful situations. The test-retest and inter-observer reliability, the internal consistency, and the discriminent validity were found to be satisfactory. To evaluate the convergent validity with the DOLOPLUS-2 and the clinical relevance of the PACSLAC, it was also completed by nurses during their work shift, with 26 additional patients, for three days per week during a period of four weeks. These results encourage us to test the PACSLAC in a comprehensive program of pain management targeting this population.

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

PubMed

García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

2018-01-08

Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications. NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .

Validity and reliability of a novel immunosuppressive adverse effects scoring system in renal transplant recipients.

PubMed

Meaney, Calvin J; Arabi, Ziad; Venuto, Rocco C; Consiglio, Joseph D; Wilding, Gregory E; Tornatore, Kathleen M

2014-06-12

After renal transplantation, many patients experience adverse effects from maintenance immunosuppressive drugs. When these adverse effects occur, patient adherence with immunosuppression may be reduced and impact allograft survival. If these adverse effects could be prospectively monitored in an objective manner and possibly prevented, adherence to immunosuppressive regimens could be optimized and allograft survival improved. Prospective, standardized clinical approaches to assess immunosuppressive adverse effects by health care providers are limited. Therefore, we developed and evaluated the application, reliability and validity of a novel adverse effects scoring system in renal transplant recipients receiving calcineurin inhibitor (cyclosporine or tacrolimus) and mycophenolic acid based immunosuppressive therapy. The scoring system included 18 non-renal adverse effects organized into gastrointestinal, central nervous system and aesthetic domains developed by a multidisciplinary physician group. Nephrologists employed this standardized adverse effect evaluation in stable renal transplant patients using physical exam, review of systems, recent laboratory results, and medication adherence assessment during a clinic visit. Stable renal transplant recipients in two clinical studies were evaluated and received immunosuppressive regimens comprised of either cyclosporine or tacrolimus with mycophenolic acid. Face, content, and construct validity were assessed to document these adverse effect evaluations. Inter-rater reliability was determined using the Kappa statistic and intra-class correlation. A total of 58 renal transplant recipients were assessed using the adverse effects scoring system confirming face validity. Nephrologists (subject matter experts) rated the 18 adverse effects as: 3.1 ± 0.75 out of 4 (maximum) regarding clinical importance to verify content validity. The adverse effects scoring system distinguished 1.75-fold increased gastrointestinal adverse effects (p=0.008) in renal transplant recipients receiving tacrolimus and mycophenolic acid compared to the cyclosporine regimen. This finding demonstrated construct validity. Intra-class correlation was 0.81 (95% confidence interval: 0.65-0.90) and Kappa statistic of 0.68 ± 0.25 for all 18 adverse effects and verified substantial inter-rater reliability. This immunosuppressive adverse effects scoring system in stable renal transplant recipients was evaluated and substantiated face, content and construct validity with inter-rater reliability. The scoring system may facilitate prospective, standardized clinical monitoring of immunosuppressive adverse drug effects in stable renal transplant recipients and improve medication adherence.

Validation study of the Japanese version of the Obsessive-Compulsive Drinking Scale.

PubMed

Tatsuzawa, Yasutaka; Yoshimasu, Haruo; Moriyama, Yasushi; Furusawa, Teruyuki; Yoshino, Aihide

2002-02-01

The Obsessive-Compulsive Drinking Scale (OCDS) is a self-rating questionnaire that measures cognitive and behavioral aspects of craving for alcohol. The OCDS consists of two subscales: the obsessive thoughts of drinking subscale (OS) and the compulsive drinking subscale (CS). This study aims to validate the Japanese version of the OCDS. First, internal consistency and discriminant validity were evaluated. Second, a prospective longitudinal 3-month outcome study of 67 patients with alcohol dependence who participated in a relapse prevention program was designed to assess the concurrent and predictive validity of the OCDS. The OCDS demonstrated high internal consistency. The OS had high discriminant validity, while the CS did not. Twenty-three patients (34.3%) dropped out of treatment. These patients had significantly higher OS scores than those who completed the program. At 3 months, the relapse group had significantly higher OCDS scores than the no relapse group. Also, the OCDS score was higher in subjects who had early-onset alcohol dependence than late-onset dependence. The OCDS is useful for evaluating cognitive aspect of craving and predicts dropout and relapse.

Investigating University Students' Preferences to Science Communication Skills: A Case of Prospective Science Teacher in Indonesia

ERIC Educational Resources Information Center

Suprapto, Nadi; Ku, Chih-Hsiung

2016-01-01

The purpose of this study was to investigate Indonesian university students' preferences to science communication skills. Data collected from 251 students who were majoring in science education program. The Learning Preferences to Science Communication (LPSC) questionnaire was developed with Indonesian language and validated through an exploratory…

The Development of Chorus Motivation Scale (CMS) for Prospective Music Teacher

ERIC Educational Resources Information Center

Ozgul, Ilhan; Yigit, Nalan

2017-01-01

The purpose of this study was to develop a Chorus Motivation Scale (CMS) that is tested in terms of reliability and construct validity by determining the student perceptions of effective motivation strategies in Chorus training in Turkish Music Teacher Training Model. In order to develop a Chorus Motivation Scale, Questionnaire-Effective…

Perceived Emotional Intelligence as Predictor of Psychological Adjustment in Adolescents: A 1-Year Prospective Study

ERIC Educational Resources Information Center

Salguero, Jose M.; Palomera, Raquel; Fernandez-Berrocal, Pablo

2012-01-01

In recent years, emotional intelligence has appeared as a predictor of adults' mental health, but little research has examined its involvement in adolescents' psychological adjustment. In this paper, we analyzed the predictive validity of perceived emotional intelligence (attention to feelings, emotional clarity, and emotional repair) over…

Evaluating the Predictive Validity of Suicidal Intent and Medical Lethality in Youth

ERIC Educational Resources Information Center

Sapyta, Jeffrey; Goldston, David B.; Erkanli, Alaattin; Daniel, Stephanie S.; Heilbron, Nicole; Mayfield, Andrew; Treadway, S. Lyn

2012-01-01

Objectives: To examine whether suicidal intent and medical lethality of past suicide attempts are predictive of future attempts, the association between intent and lethality, and the consistency of these characteristics across repeated attempts among youth. Method: Suicide attempts in a 15-year prospective study of 180 formerly psychiatrically…

Borderline Personality Traits and Disorder: Predicting Prospective Patient Functioning

ERIC Educational Resources Information Center

Hopwood, Christopher J.; Zanarini, Mary C.

2010-01-01

Objective: Decisions about the composition of personality assessment in the "Diagnostic and Statistical Manual of Mental Disorders" (5th ed.; DSM-V) will be heavily influenced by the clinical utility of candidate constructs. In this study, we addressed 1 aspect of clinical utility by testing the incremental validity of 5-factor model (FFM)…

Comparative Analysis of Expectancies of Efficacy in In-Service and Prospective Teachers

ERIC Educational Resources Information Center

de la Torre Cruz, Manuel J.; Casanova Arias, Pedro F.

2007-01-01

This study examines the beliefs about effective teaching in student teachers and inservice teachers. We constructed a measurement composed of an adaptation in Spanish of the Gibson and Dembo's (1984. Teacher efficacy: A construct validation. "Journal of Educational Psychology", 76, 569-582). Teacher Efficacy Scale and of the items…

Quantitative estimation of the fluorescent parameters for crop leaves with the Bayesian inversion

USDA-ARS?s Scientific Manuscript database

In this study, the fluorescent parameters of crop leaves were retrieved from the leaf hyperspectral measurements by inverting the FluorMODleaf model, which is a leaf-level fluorescence model that is based on the widely used and validated PROSPECT (leaf optical properties) model and can simulate the ...

Initial Validation of the Activity Choice Index among Overweight Women

ERIC Educational Resources Information Center

Mullen, Sean P.; Silva, Marlene N.; Sardinha, Luís B.; Teixeira, Pedro J.

2016-01-01

Purpose: This prospective study was designed to evaluate psychometric properties of the Activity Choice Index (ACI), a measure for assessing one's choice to engage in more effortful, physically active behaviors in the course of daily routines over less-demanding, sedentary behaviors, in a sample of overweight women. Method: The sample included 192…

The Metacognitions about Gambling Questionnaire: Development and psychometric properties.

PubMed

Caselli, Gabriele; Fernie, Bruce; Canfora, Flaviano; Mascolo, Cristina; Ferrari, Andrea; Antonioni, Maria; Giustina, Lucia; Donato, Gilda; Marcotriggiani, Antonella; Bertani, Andrea; Altieri, Antonella; Pellegrini, Eliana; Spada, Marcantonio M

2018-03-01

Recent research has suggested that metacognitions may play a role across the spectrum of addictive behaviours. The goal of our studies was to develop the first self-report scale of metacognitions about gambling. We conducted three studies with one community (n = 165) and two clinical (n = 110; n = 87) samples to test the structure and psychometric properties of the Metacognitions about Gambling Questionnaire and examined its capacity to prospectively predict severity of gambling. Findings supported a two factor solution consisting of positive and negative metacognitions about gambling. Internal consistency, predictive and divergent validity were acceptable. All the factors of the Metacognitions about Gambling Questionnaire correlated positively with gambling severity. Regression analyses showed that negative metacognitions about gambling were significantly associated to gambling severity over and above negative affect and gambling-specific cognitive distortions. Finally only gambling severity and negative metacognitions about gambling were significant prospective predictors of gambling severity as measured three months later. The Metacognitions about Gambling Questionnaire was shown to possess good psychometric properties, as well as predictive and divergent validity within the populations that were tested. Copyright © 2018 Elsevier B.V. All rights reserved.

Measuring Medication Adherence in Pediatric Cancer: An Approach to Validation.

PubMed

Rohan, Jennifer M; Fukuda, Tsuyoshi; Alderfer, Melissa A; Wetherington Donewar, Crista; Ewing, Linda; Katz, Ernest R; Muriel, Anna C; Vinks, Alexander A; Drotar, Dennis

2017-03-01

This study described the prospective relationship between pharmacological and behavioral measures of 6-mercaptopurine (6MP) medication adherence in a multisite cohort of pediatric patients diagnosed with cancer ( N  = 139). Pharmacological measures (i.e., metabolite concentrations) assessed 6MP intake. Behavioral measures (e.g., electronic monitoring) described adherence patterns over time. Three metabolite profiles were identified across 15 months: one group demonstrated low levels of both metabolites (40.8%) consistent with nonadherence and/or suboptimal therapy; two other groups demonstrated metabolite clusters indicative of adequate adherence (59.2%). Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates. To our knowledge, this was the first study to prospectively validate a pharmacological measure of medication adherence with a behavioral adherence measure in a relatively large sample of pediatric patients with cancer. Using multiple methods of adherence measurement could inform clinical care and target patients in need of intervention. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Two-Tiered Violence Risk Estimates: a validation study of an integrated-actuarial risk assessment instrument.

PubMed

Mills, Jeremy F; Gray, Andrew L

2013-11-01

This study is an initial validation study of the Two-Tiered Violence Risk Estimates instrument (TTV), a violence risk appraisal instrument designed to support an integrated-actuarial approach to violence risk assessment. The TTV was scored retrospectively from file information on a sample of violent offenders. Construct validity was examined by comparing the TTV with instruments that have shown utility to predict violence that were prospectively scored: The Historical-Clinical-Risk Management-20 (HCR-20) and Lifestyle Criminality Screening Form (LCSF). Predictive validity was examined through a long-term follow-up of 12.4 years with a sample of 78 incarcerated offenders. Results show the TTV to be highly correlated with the HCR-20 and LCSF. The base rate for violence over the follow-up period was 47.4%, and the TTV was equally predictive of violent recidivism relative to the HCR-20 and LCSF. Discussion centers on the advantages of an integrated-actuarial approach to the assessment of violence risk.

A prospectively validated nomogram for predicting the risk of chemotherapy-induced febrile neutropenia: a multicenter study.

PubMed

Bozcuk, H; Yıldız, M; Artaç, M; Kocer, M; Kaya, Ç; Ulukal, E; Ay, S; Kılıç, M P; Şimşek, E H; Kılıçkaya, P; Uçar, S; Coskun, H S; Savas, B

2015-06-01

There is clinical need to predict risk of febrile neutropenia before a specific cycle of chemotherapy in cancer patients. Data on 3882 chemotherapy cycles in 1089 consecutive patients with lung, breast, and colon cancer from four teaching hospitals were used to construct a predictive model for febrile neutropenia. A final nomogram derived from the multivariate predictive model was prospectively confirmed in a second cohort of 960 consecutive cases and 1444 cycles. The following factors were used to construct the nomogram: previous history of febrile neutropenia, pre-cycle lymphocyte count, type of cancer, cycle of current chemotherapy, and patient age. The predictive model had a concordance index of 0.95 (95 % confidence interval (CI) = 0.91-0.99) in the derivation cohort and 0.85 (95 % CI = 0.80-0.91) in the external validation cohort. A threshold of 15 % for the risk of febrile neutropenia in the derivation cohort was associated with a sensitivity of 0.76 and specificity of 0.98. These figures were 1.00 and 0.49 in the validation cohort if a risk threshold of 50 % was chosen. This nomogram is helpful in the prediction of febrile neutropenia after chemotherapy in patients with lung, breast, and colon cancer. Usage of this nomogram may help decrease the morbidity and mortality associated with febrile neutropenia and deserves further validation.

Validating SPICES as a Screening Tool for Frailty Risks among Hospitalized Older Adults

PubMed Central

Aronow, Harriet Udin; Borenstein, Jeff; Haus, Flora; Braunstein, Glenn D.; Bolton, Linda Burnes

2014-01-01

Older patients are vulnerable to adverse hospital events related to frailty. SPICES, a common screening protocol to identify risk factors in older patients, alerts nurses to initiate care plans to reduce the probability of patient harm. However, there is little published validating the association between SPICES and measures of frailty and adverse outcomes. This paper used data from a prospective cohort study on frailty among 174 older adult inpatients to validate SPICES. Almost all patients met one or more SPICES criteria. The sum of SPICES was significantly correlated with age and other well-validated assessments for vulnerability, comorbid conditions, and depression. Individuals meeting two or more SPICES criteria had a risk of adverse hospital events three times greater than individuals with either no or one criterion. Results suggest that as a screening tool used within 24 hours of admission, SPICES is both valid and predictive of adverse events. PMID:24876954

Predictive validity of the Braden Scale, Norton Scale, and Waterlow Scale in the Czech Republic.

PubMed

Šateková, Lenka; Žiaková, Katarína; Zeleníková, Renáta

2017-02-01

The aim of this study was to determine the predictive validity of the Braden, Norton, and Waterlow scales in 2 long-term care departments in the Czech Republic. Assessing the risk for developing pressure ulcers is the first step in their prevention. At present, many scales are used in clinical practice, but most of them have not been properly validated yet (for example, the Modified Norton Scale in the Czech Republic). In the Czech Republic, only the Braden Scale has been validated so far. This is a prospective comparative instrument testing study. A random sample of 123 patients was recruited. The predictive validity of the pressure ulcer risk assessment scales was evaluated based on sensitivity, specificity, positive and negative predictive values, and the area under the receiver operating characteristic curve. The data were collected from April to August 2014. In the present study, the best predictive validity values were observed for the Norton Scale, followed by the Braden Scale and the Waterlow Scale, in that order. We recommended that the above 3 pressure ulcer risk assessment scales continue to be evaluated in the Czech clinical setting. © 2016 John Wiley & Sons Australia, Ltd.

Prospective evaluation of a clinical guideline recommending hospital length of stay in upper gastrointestinal tract hemorrhage.

PubMed

Hay, J A; Maldonado, L; Weingarten, S R; Ellrodt, A G

Upper gastrointestinal tract hemorrhage (UGIH) is a common and potentially life-threatening disorder. Resource utilization can vary without adverse effect on patient outcome. Clinical practice guidelines are a potential solution to reduce variation in practice while improving patient outcomes. To validate prospectively the safety, acceptability, and impact of a clinical practice guideline defining the medically appropriate length of stay (LOS) for patients hospitalized with UGIH. Prospective, controlled time-series study with an alternate-month design. Outcome surveyors and patients were blinded to study group allocation. GUIDELINE: A retrospectively validated scoring system using 4 independent variables: hemodynamics, time from bleeding, comorbidity, and esophagogastroduodenoscopy (EGD) findings to predict risk of adverse events. The quantitative risk for the low-risk subset was 0.6% (95% confidence interval [CI], 0.0%-2.0%) for subsequent complications and 0% (95% CI, 0.0%-0.9%) for life-threatening complications from this retrospective evaluation. A 1000-bed, not-for-profit, university-affiliated teaching hospital. Consecutive adult patients hospitalized for acute UGIH. Concurrent feedback of guideline recommendation (same-day hospital discharge) to physicians caring for patients at low risk for complication. No risk information was provided during control months. Seventy percent (209/299) of UGIH patients achieved low-risk status according to the guideline and were therefore potentially suitable for early discharge from the hospital. Providing real-time quantitative risk information (intervention group only) was associated with an increase in guideline compliance from 30% to 70% (P<.001) and a decrease in mean (SD) LOS from 4.6 (3.5) days to 2.9 (1.3) days (mean reduction of 1.7 days per patient; P<.001). No differences in complications, patient health status, or patient satisfaction were found when measured 1 month after discharge. An independent variable predicting decreased hospital LOS for low-risk UGIH patients was early EGD. Implementation of the clinical practice guideline safely reduced hospital LOS for selected low-risk patients with acute UGIH. Further prospective validation in other settings is warranted.

Prospective validation of %p2PSA and the Prostate Health Index, in prostate cancer detection in initial prostate biopsies of Asian men, with total PSA 4-10 ng ml-1.

PubMed

Tan, Lincoln Gl; Tan, Yung Khan; Tai, Bee Choo; Tan, Karen Ml; Gauhar, Vineet; Tiong, Ho Yee; Hawkins, Robert Cw; Thamboo, Thomas P; Hong, Felicia Sk; Chiong, Edmund

2017-01-01

Despite its widespread use for prostate cancer screening, low specificity makes PSA a suboptimal biomarker, especially in the diagnostic "gray zone" of 4-10 ng ml-1 . False-positives lead to unnecessary biopsies with attendant morbidities. This is the first prospective validation study of %p2PSA and the Prostate Health Index (PHI) in Asian men presenting with a total PSA between 4.0 and 10 ng ml-1 . We studied 157 Asian men between 50 and 75 years old, with normal per rectal prostate examinations, undergoing their first prostate biopsy, using a standardized biopsy protocol, for PSA levels of 4-10 ng ml-1 . Thirty (19.1%) were found to have prostate cancer on biopsy. Statistically significant differences between patients with and without prostate cancer were found for total PSA, p2PSA, %p2PSA, and PHI. The areas under the curve of the receiver operating characteristic curve for total PSA, %fPSA, %p2PSA, and PHI were 0.479, 0.420, 0.695, and 0.794, respectively. PHI predicts prostatic biopsies results best. At a sensitivity of 90%, the specificity (95% CI) of PHI was 58.3%, more than triple the specificity of total PSA at 17.3%, potentially avoiding 77 (49%) unnecessary biopsies. Similar to studies in mainly Caucasian populations, we have prospectively shown that %p2PSA and PHI greatly outperform total and free to total PSA ratio, in the detection of prostate cancer at first biopsy. Higher PHI levels also correspond to increasing the risk of detecting GS ≥7 cancers. We have validated the use of PHI to aid decision-making regarding prostate biopsies in Asian men with serum PSA between 4 and 10 ng ml-1 .

Using the Training Reactions Questionnaire to Analyze the Reactions of University Students Undergoing Career-Related Training in Jordan: A Prospective Human Resource Development Approach

ERIC Educational Resources Information Center

Khasawneh, Samer; Al-Zawahreh, Abdelghafour

2015-01-01

The primary purpose of the present study was to validate Morgan and Casper's training reactions questionnaire (TRQ) for use in Jordan. The study also investigated the reactions of university students to career-related training programs. Another purpose of the study was to determine the impact of certain aspects of training programs on the overall…

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

A prospective, multisite, international validation of the Complex Regional Pain Syndrome Severity Score.

PubMed

Harden, R Norman; Maihofner, Christian; Abousaad, Elias; Vatine, Jean-Jacques; Kirsling, Amy; Perez, Roberto S G M; Kuroda, Maxine; Brunner, Florian; Stanton-Hicks, Michael; Marinus, Johan; van Hilten, Jacobus J; Mackey, Sean; Birklein, Frank; Schlereth, Tanja; Mailis-Gagnon, Angela; Graciosa, Joe; Connoly, Sara B; Dayanim, David; Massey, Michael; Frank, Hadas; Livshitz, Anatoly; Bruehl, Stephen

2017-08-01

Clinical diagnosis of complex regional pain syndrome (CRPS) is a dichotomous (yes/no) categorization, a format necessary for clinical decision making. Such dichotomous diagnostic categories do not convey an individual's subtle gradations in the severity of the condition over time and have poor statistical power when used as an outcome measure in research. This prospective, international, multicenter study slightly modified and further evaluated the validity of the CRPS Severity Score (CSS), a continuous index of CRPS severity. Using a prospective design, medical evaluations were conducted in 156 patients with CRPS to compare changes over time in CSS scores between patients initiating a new treatment program and patients on stable treatment regimens. New vs stable categorizations were supported by greater changes in pain and function in the former. Results indicated that CSS values in the stable CRPS treatment group exhibited much less change over time relative to the new treatment group, with intraclass correlations nearly twice as large in the former. A calculated smallest real difference value revealed that a change in the CSS of ≥4.9 scale points would indicate real differences in CRPS symptomatology (with 95% confidence). Across groups, larger changes in CRPS features on the CSS over time were associated in the expected direction with greater changes in pain intensity, fatigue, social functioning, ability to engage in physical roles, and general well-being. The overall pattern of findings further supports the validity of the CSS as a measure of CRPS severity and suggests it may prove useful in clinical monitoring and outcomes research.

Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis.

PubMed

Yi, Honglei; Wei, Xianzhao; Zhang, Wei; Chen, Ziqiang; Wang, Xinhui; Ji, Xinran; Zhu, Xiaodong; Wang, Fei; Xu, Ximing; Li, Zhikun; Fan, Jianping; Wang, Chuanfeng; Chen, Kai; Zhang, Guoyou; Zhao, Yinchuan; Li, Ming

2014-05-01

This was a prospective clinical validation study. To evaluate the reliability and validity of the adapted simplified Chinese version of Swiss Spinal Stenosis (SC-SSS) Questionnaire. The SSS Questionnaire is a reliable and valid instrument to assess the perception of function and pain for patients with degenerative lumbar spinal stenosis. However, there is no culturally adapted SSS Questionnaire for use in mainland China. This was a prospective clinical validation study. The adaption was conducted according to International Quality of Life Assessment Project guidelines. To examine the psychometric properties of the adapted SC-SSS Questionnaire, a sample of 105 patients with lumbar spinal stenosis were included. Thirty-two patients were randomly selected to evaluate the test-retest reliability. Reliability assessment of the SC-SSS Questionnaire was determined by calculating Cronbach α and intraclass coefficient values. Concurrent validity was assessed by correlating SC-SSS Questionnaire scores with relevant domains of the 36-Item Short Form Health Survey. Cronbach α of the symptom severity scale, physical function scale, patients, and satisfaction scale of SC-SSS Questionnaire are 0.89, 0.86, 0.91, respectively, which revealed very good internal consistency. The test-retest reproducibility was found to be excellent with the intraclass correlation coefficient of 0.93, 0.91, and 0.95. In terms of concurrent validity, SC-SSS Questionnaire had good correlation with physical functioning and bodily pain of 36-Item Short Form Health Survey (r = 0.663, 0.653) and low correlation with mental health (r = 0.289). The physical function scale had good correlation with physical functioning of 36-Item Short Form Health Survey (r = 0.637), whereas the rest had moderate correlation. The satisfaction scale score was highly correlated with the change in the symptom severity (r = 0.71) and physical function (r = 0.68) scale score. The SC-SSS Questionnaire showed satisfactory reliability and validity in the evaluation of functionality in patients with lumbar spinal stenosis who are experiencing neurogenic claudication. It is simple and easy to use and can be recommended in clinical and research practice in mainland China. 3.

Prospective validation of a surgical complications grading system in a cohort of 2114 patients.

PubMed

Mazeh, Haggi; Cohen, Oded; Mizrahi, Ido; Hamburger, Tamar; Stojadinovic, Alexander; Abu-Wasel, Bassam; Alaiyan, Bilal; Freund, Herbert R; Eid, Ahmed; Nissan, Aviram

2014-05-01

We recently reported a grading system for surgical complications. This system proved to have a high sensitivity for recording minor but meaningful complications prolonging hospital stay in patients after colorectal surgery. We aimed to prospectively validate the complication grading system in a general surgery department over 1 year. All surgical procedures and related complications were prospectively recorded between January 1st and December 31st, 2009. Surgical complications were graded on a severity scale of 1-5. The system classifies short-term outcome by grade emphasizing intensity of therapy required for treatment of the defined complication. During the study period, 2114 patients underwent surgery. Elective and oncological surgeries were performed in 1606 (76%) and 465 (22%) patients, respectively. There were 422 surgical complications in 304 (14%) patients (Grade 1/2: 203 [67%]; Grade 3/4: 90 [29%]; Grade 5: 11 [4%]). Median length of stay correlated significantly with complication severity: 2.3 d for no complication, 6.2 and 11.8 d for Grades 1/2 and 3/4, respectively (P < 0.001). Older age (OR 2.75, P < 0.001), comorbidities (OR 1.44, P = 0.02), American Society of Anesthesiology score >2 (OR 2.07, P < 0.001), contamination Grade (OR 1.85, P = 0.001), oncological (OR 2.82, P < 0.001), open (OR 1.22, P = 0.03), prolonged >120 min (OR 2.08, P < 0.001), and emergency surgery (OR 1.42, P = 0.02) independently predicted postoperative complications. This system of grading surgical complications permits standardized reporting of surgical morbidity according to the severity of impact. Prospective validation of this system supports its use in a general surgery setting as a tool for surgical outcome assessment and quality assurance. Copyright © 2014 Elsevier Inc. All rights reserved.

Number of organ dysfunctions predicts mortality in emergency department patients with suspected infection: a multicenter validation study.

PubMed

Jessen, Marie K; Skibsted, Simon; Shapiro, Nathan I

2017-06-01

The aim of this study was to validate the association between number of organ dysfunctions and mortality in emergency department (ED) patients with suspected infection. This study was conducted at two medical care center EDs. The internal validation set was a prospective cohort study conducted in Boston, USA. The external validation set was a retrospective case-control study conducted in Aarhus, Denmark. The study included adult patients (>18 years) with clinically suspected infection. Laboratory results and clinical data were used to assess organ dysfunctions. Inhospital mortality was the outcome measure. Multivariate logistic regression was used to determine the independent mortality odds for number and types of organ dysfunctions. We enrolled 4952 (internal) and 483 (external) patients. The mortality rate significantly increased with increasing number of organ dysfunctions: internal validation: 0 organ dysfunctions: 0.5% mortality, 1: 3.6%, 2: 9.5%, 3: 17%, and 4 or more: 37%; external validation: 2.2, 6.7, 17, 41, and 57% mortality (both P<0.001 for trend). Age-adjusted and comorbidity-adjusted number of organ dysfunctions remained an independent predictor. The effect of specific types of organ dysfunction on mortality was most pronounced for hematologic [odds ratio (OR) 3.3 (95% confidence interval (CI) 2.0-5.4)], metabolic [OR 3.3 (95% CI 2.4-4.6); internal validation], and cardiovascular dysfunctions [OR 14 (95% CI 3.7-50); external validation]. The number of organ dysfunctions predicts sepsis mortality.

Predicting Oral Health-Related Behaviour in the Parents of Preschool Children: An Application of the Theory of Planned Behaviour

ERIC Educational Resources Information Center

Van den Branden, Sigrid; Van den Broucke, Stephan; Leroy, Roos; Declerck, Dominique; Hoppenbrouwers, Karel

2015-01-01

Objective: This study aimed to test the predictive validity of the Theory of Planned Behaviour (TPB) when applied to the oral health-related behaviours of parents towards their preschool children in a cross-sectional and prospective design over a 5-year interval. Methods: Data for this study were obtained from parents of 1,057 children born…

Optimizing prevention of hospital-acquired venous thromboembolism (VTE): prospective validation of a VTE risk assessment model.

PubMed

Maynard, Gregory A; Morris, Timothy A; Jenkins, Ian H; Stone, Sarah; Lee, Joshua; Renvall, Marian; Fink, Ed; Schoenhaus, Robert

2010-01-01

Hospital-acquired (HA) venous thromboembolism (VTE) is a common source of morbidity/mortality. Prophylactic measures are underutilized. Available risk assessment models/protocols are not prospectively validated. Improve VTE prophylaxis, reduce HA VTE, and prospectively validate a VTE risk-assessment model. Observational design. Academic medical center. Adult inpatients on medical/surgical services. A simple VTE risk assessment linked to a menu of preferred VTE prophylaxis methods, embedded in order sets. Education, audit/feedback, and concurrent identification of nonadherence. Randomly sampled inpatient audits determined the percent of patients with "adequate" VTE prevention. HA VTE cases were identified concurrently via digital imaging system. Interobserver agreement for VTE risk level and judgment of adequate prophylaxis were calculated from 150 random audits. Interobserver agreement with 5 observers was high (kappa score for VTE risk level = 0.81, and for judgment of "adequate" prophylaxis = 0.90). The percent of patients on adequate prophylaxis improved each of the 3 years (58%, 78%, and 93%; P < 0.001) and reached 98% in the last 6 months of 2007; 361 cases of HA VTE occurred over 3 years. Significant reductions for the risk of HA VTE (risk ratio [RR] = 0.69; 95% confidence interval [CI] = 0.47-0.79) and preventable HA VTE (RR = 0.14; 95% CI = 0.06-0.31) occurred. We detected no increase in heparin-induced thrombocytopenia (HIT) or prophylaxis-related bleeding using administrative data/chart review. We prospectively validated a VTE risk-assessment/prevention protocol by demonstrating ease of use, good interobserver agreement, and effectiveness. Improved VTE prophylaxis resulted in a substantial reduction in HA VTE. (c) 2010 Society of Hospital Medicine.

External validation of a published nomogram for prediction of brain metastasis in patients with extra-cerebral metastatic breast cancer and risk regression analysis.

PubMed

Genre, Ludivine; Roché, Henri; Varela, Léonel; Kanoun, Dorra; Ouali, Monia; Filleron, Thomas; Dalenc, Florence

2017-02-01

Survival of patients with metastatic breast cancer (MBC) suffering from brain metastasis (BM) is limited and this event is usually fatal. In 2010, the Graesslin's nomogram was published in order to predict subsequent BM in patients with breast cancer (BC) with extra-cerebral metastatic disease. This model aims to select a patient population at high risk for BM and thus will facilitate the design of prevention strategies and/or the impact of early treatment of BM in prospective clinical studies. Nomogram external validation was retrospectively applied to patients with BC and later BM between January 2005 and December 2012, treated in our institution. Moreover, risk factors of BM appearance were studied by Fine and Gray's competing risk analysis. Among 492 patients with MBC, 116 developed subsequent BM. Seventy of them were included for the nomogram validation. The discrimination is good (area under curve = 0.695 [95% confidence interval, 0.61-0.77]). Risk factors of BM appearance are: human epidermal growth factor receptor 2 (HER2) overexpression/amplification, triple-negative BC and number of extra-cerebral metastatic sites (>1). With a competing risk model, we highlight the nomogram interest for HER2+ tumour subgroup exclusively. Graesslin's nomogram external validation demonstrates exportability and reproducibility. Importantly, the competing risk model analysis provides additional information for the design of prospective trials concerning the early diagnosis of BM and/or preventive treatment on high risk patients with extra-cerebral metastatic BC. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Validated Clinical Risk Prediction Model for Lung Cancer in Smokers of All Ages and Exposure Types: A HUNT Study.

PubMed

Markaki, Maria; Tsamardinos, Ioannis; Langhammer, Arnulf; Lagani, Vincenzo; Hveem, Kristian; Røe, Oluf Dimitri

2018-05-01

Lung cancer causes >1·6 million deaths annually, with early diagnosis being paramount to effective treatment. Here we present a validated risk assessment model for lung cancer screening. The prospective HUNT2 population study in Norway examined 65,237 people aged >20years in 1995-97. After a median of 15·2years, 583 lung cancer cases had been diagnosed; 552 (94·7%) ever-smokers and 31 (5·3%) never-smokers. We performed multivariable analyses of 36 candidate risk predictors, using multiple imputation of missing data and backwards feature selection with Cox regression. The resulting model was validated in an independent Norwegian prospective dataset of 45,341 ever-smokers, in which 675 lung cancers had been diagnosed after a median follow-up of 11·6years. Our final HUNT Lung Cancer Model included age, pack-years, smoking intensity, years since smoking cessation, body mass index, daily cough, and hours of daily indoors exposure to smoke. External validation showed a 0·879 concordance index (95% CI [0·866-0·891]) with an area under the curve of 0·87 (95% CI [0·85-0·89]) within 6years. Only 22% of ever-smokers would need screening to identify 81·85% of all lung cancers within 6years. Our model of seven variables is simple, accurate, and useful for screening selection. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Validation of risk stratification for children with febrile neutropenia in a pediatric oncology unit in India.

PubMed

Das, Anirban; Trehan, Amita; Oberoi, Sapna; Bansal, Deepak

2017-06-01

The study aims to validate a score predicting risk of complications in pediatric patients with chemotherapy-related febrile neutropenia (FN) and evaluate the performance of previously published models for risk stratification. Children diagnosed with cancer and presenting with FN were evaluated in a prospective single-center study. A score predicting the risk of complications, previously derived in the unit, was validated on a prospective cohort. Performance of six predictive models published from geographically distinct settings was assessed on the same cohort. Complications were observed in 109 (26.3%) of 414 episodes of FN over 15 months. A risk score based on undernutrition (two points), time from last chemotherapy (<7 days = two points), presence of a nonupper respiratory focus of infection (two points), C-reactive protein (>60 mg/l = five points), and absolute neutrophil count (<100 per μl = two points) was used to stratify patients into "low risk" (score <7, n = 208) and assessed using the following parameters: overall performance (Nagelkerke R 2 = 34.4%), calibration (calibration slope = 0.39; P = 0.25 in Hosmer-Lemeshow test), discrimination (c-statistic = 0.81), overall sensitivity (86%), negative predictive value (93%), and clinical net benefit (0.43). Six previously published rules demonstrated inferior performance in this cohort. An indigenous decision rule using five simple predefined variables was successful in identifying children at risk for complications. Prediction models derived in developed nations may not be appropriate for low-middle-income settings and need to be validated before use. © 2016 Wiley Periodicals, Inc.

Early prediction of intensive care unit-acquired weakness using easily available parameters: a prospective observational study.

PubMed

Wieske, Luuk; Witteveen, Esther; Verhamme, Camiel; Dettling-Ihnenfeldt, Daniela S; van der Schaaf, Marike; Schultz, Marcus J; van Schaik, Ivo N; Horn, Janneke

2014-01-01

An early diagnosis of Intensive Care Unit-acquired weakness (ICU-AW) using muscle strength assessment is not possible in most critically ill patients. We hypothesized that development of ICU-AW can be predicted reliably two days after ICU admission, using patient characteristics, early available clinical parameters, laboratory results and use of medication as parameters. Newly admitted ICU patients mechanically ventilated ≥2 days were included in this prospective observational cohort study. Manual muscle strength was measured according to the Medical Research Council (MRC) scale, when patients were awake and attentive. ICU-AW was defined as an average MRC score <4. A prediction model was developed by selecting predictors from an a-priori defined set of candidate predictors, based on known risk factors. Discriminative performance of the prediction model was evaluated, validated internally and compared to the APACHE IV and SOFA score. Of 212 included patients, 103 developed ICU-AW. Highest lactate levels, treatment with any aminoglycoside in the first two days after admission and age were selected as predictors. The area under the receiver operating characteristic curve of the prediction model was 0.71 after internal validation. The new prediction model improved discrimination compared to the APACHE IV and the SOFA score. The new early prediction model for ICU-AW using a set of 3 easily available parameters has fair discriminative performance. This model needs external validation.

A scoring system for ascertainment of incident stroke; the Risk Index Score (RISc).

PubMed

Kass-Hout, T A; Moyé, L A; Smith, M A; Morgenstern, L B

2006-01-01

The main objective of this study was to develop and validate a computer-based statistical algorithm that could be translated into a simple scoring system in order to ascertain incident stroke cases using hospital admission medical records data. The Risk Index Score (RISc) algorithm was developed using data collected prospectively by the Brain Attack Surveillance in Corpus Christi (BASIC) project, 2000. The validity of RISc was evaluated by estimating the concordance of scoring system stroke ascertainment to stroke ascertainment by physician and/or abstractor review of hospital admission records. RISc was developed on 1718 randomly selected patients (training set) and then statistically validated on an independent sample of 858 patients (validation set). A multivariable logistic model was used to develop RISc and subsequently evaluated by goodness-of-fit and receiver operating characteristic (ROC) analyses. The higher the value of RISc, the higher the patient's risk of potential stroke. The study showed RISc was well calibrated and discriminated those who had potential stroke from those that did not on initial screening. In this study we developed and validated a rapid, easy, efficient, and accurate method to ascertain incident stroke cases from routine hospital admission records for epidemiologic investigations. Validation of this scoring system was achieved statistically; however, clinical validation in a community hospital setting is warranted.

The use of observational scales to monitor symptom control and depth of sedation in patients requiring palliative sedation: a systematic review.

PubMed

Brinkkemper, Tijn; van Norel, Arjanne M; Szadek, Karolina M; Loer, Stephan A; Zuurmond, Wouter W A; Perez, Roberto S G M

2013-01-01

Palliative sedation is the intentional lowering of consciousness of a patient in the last phase of life to relieve suffering from refractory symptoms such as pain, delirium and dyspnoea. In this systematic review, we evaluated the use of monitoring scales to assess the degree of control of refractory symptoms and/or the depth of the sedation. A database search of PubMed and Embase was performed up to January 2010 using the search terms 'palliative sedation' OR 'terminal sedation'. Retro- and prospective studies as well as reviews and guidelines containing information about monitoring of palliative sedation, written in the English, German or Dutch language were included. The search yielded 264 articles of which 30 were considered relevant. Most studies focused on monitoring refractory symptoms (pain, fatigue or delirium) or the level of awareness to control the level of sedation. Four prospective and one retrospective study used scales validated in other settings: the Numeric Pain Rating Scale, the Visual Analogue Scale, the Memorial Delirium Assessment Scale, the Communication Capacity Scale and Agitation Distress Scale. Only the Community Capacity Scale was partially validated for use in a palliative sedation setting. One guideline described the use of a scale validated in another setting. A minority of studies reported the use of observational scales to monitor the effect of palliative sedation. Future studies should be focused on establishing proper instruments, most adequate frequency and timing of assessment, and interdisciplinary evaluation of sedation depth and symptom control for palliative sedation.

Clinical validation of the nursing diagnosis Risk for Aspiration among patients who experienced a cerebrovascular accident.

PubMed

Cavalcante, Tahissa Frota; de Araújo, Thelma Leite; Moreira, Rafaella Pessoa; Guedes, Nirla Gomes; Lopes, Marcos Venicios de Oliveira; da Silva, Viviane Martins

2013-01-01

the study's objective was the clinical validation of the nursing diagnosis Risk for Aspiration among patients who experienced cerebrovascular accidents (CVA). a prospective cohort study was conducted with 24 patients hospitalized due to a CVA. The instrument used to collect the data addressed the risk factors for respiratory aspiration, validated by concept analysis and by experts. the most frequent risk factors for respiratory aspiration were: dysphagia (54.2%) and impaired physical mobility (41.7%). The prevalence of the nursing diagnosis Risk for Aspiration was 58.3% and the prevalence of respiratory aspiration over the span of 48 hours (monitoring period) was 37.5%. Risk factors for dysphagia and impaired physical mobility were significantly associated with respiratory aspiration. the risk factors dysphagia and impaired physical mobility are good predictors of the nursing diagnosis Risk for Aspiration. This study contributed to improving the NANDA-I Taxonomy and the systematization of the nursing process.

Development and validation of response markers to predict survival and pleurodesis success in patients with malignant pleural effusion (PROMISE): a multicohort analysis.

PubMed

Psallidas, Ioannis; Kanellakis, Nikolaos I; Gerry, Stephen; Thézénas, Marie Laëtitia; Charles, Philip D; Samsonova, Anastasia; Schiller, Herbert B; Fischer, Roman; Asciak, Rachelle; Hallifax, Robert J; Mercer, Rachel; Dobson, Melissa; Dong, Tao; Pavord, Ian D; Collins, Gary S; Kessler, Benedikt M; Pass, Harvey I; Maskell, Nick; Stathopoulos, Georgios T; Rahman, Najib M

2018-06-13

The prevalence of malignant pleural effusion is increasing worldwide, but prognostic biomarkers to plan treatment and to understand the underlying mechanisms of disease progression remain unidentified. The PROMISE study was designed with the objectives to discover, validate, and prospectively assess biomarkers of survival and pleurodesis response in malignant pleural effusion and build a score that predicts survival. In this multicohort study, we used five separate and independent datasets from randomised controlled trials to investigate potential biomarkers of survival and pleurodesis. Mass spectrometry-based discovery was used to investigate pleural fluid samples for differential protein expression in patients from the discovery group with different survival and pleurodesis outcomes. Clinical, radiological, and biological variables were entered into least absolute shrinkage and selection operator regression to build a model that predicts 3-month mortality. We evaluated the model using internal and external validation. 17 biomarker candidates of survival and seven of pleurodesis were identified in the discovery dataset. Three independent datasets (n=502) were used for biomarker validation. All pleurodesis biomarkers failed, and gelsolin, macrophage migration inhibitory factor, versican, and tissue inhibitor of metalloproteinases 1 (TIMP1) emerged as accurate predictors of survival. Eight variables (haemoglobin, C-reactive protein, white blood cell count, Eastern Cooperative Oncology Group performance status, cancer type, pleural fluid TIMP1 concentrations, and previous chemotherapy or radiotherapy) were validated and used to develop a survival score. Internal validation with bootstrap resampling and external validation with 162 patients from two independent datasets showed good discrimination (C statistic values of 0·78 [95% CI 0·72-0·83] for internal validation and 0·89 [0·84-0·93] for external validation of the clinical PROMISE score). To our knowledge, the PROMISE score is the first prospectively validated prognostic model for malignant pleural effusion that combines biological and clinical parameters to accurately estimate 3-month mortality. It is a robust, clinically relevant prognostic score that can be applied immediately, provide important information on patient prognosis, and guide the selection of appropriate management strategies. European Respiratory Society, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. Copyright © 2018 Elsevier Ltd. All rights reserved.

Applicability of action planning and coping planning to dental flossing among Norwegian adults: a confirmatory factor analysis approach.

PubMed

Astrøm, Anne Nordrehaug

2008-06-01

Using a prospective design and a representative sample of 25-yr-old Norwegians, this study hypothesized that action planning and coping planning will add to the prediction of flossing at 4 wk of follow-up over and above the effect of intention and previous flossing. This study tested the validity of a proposed 3-factor structure of the measurement model of intention, action planning, and coping planning and for its invariance across gender. A survey was conducted in three Norwegian counties, and 1,509 out of 8,000 randomly selected individuals completed questionnaires assessing the constructs of action planning and coping planning related to daily flossing. A random subsample of 500 participants was followed up at 4 wk with a telephone interview to assess flossing. Confirmatory factor analysis (CFA) confirmed the proposed 3-factor model after respecification. Although the chi-square test was statistically significant [chi(2) = 58.501, degrees of freedom (d.f.) = 17), complementary fit indices were satisfactory [goodness-of-fit index (GFI) = 0.99, root mean squared error of approximation (RMSEA) = 0.04]. Multigroup CFA provided evidence of complete invariance of the measurement model across gender. After controlling for previous flossing, intention (beta = 0.08) and action planning (beta = 0.11) emerged as independent predictors of subsequent flossing, accounting for 2.3% of its variance. Factorial validity of intention, action planning and coping planning, and the validity of action planning in predicting flossing prospectively, was confirmed by the present study.

[Multicentre, prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of the pressure sores in newborns and up to 8 years old children].

PubMed

Chiari, Paolo; Poli, Marco; Magli, Claudia; Bascelli, Emanuele; Rocchi, Roberto; Bolognini, Silvia; Tartari, Piero; Armuzzi, Roberta; Rossi, Gianna; Peghetti, Angela; Biavati, Catia; Fontana, Mirella; Gazineo, Domenica; Cordella, Simona; Tiozzo, Emanuela; Ciliento, Gaetano; Carta, Giovanna; Taddia, Patrizia

2012-01-01

Multicenter prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of pressure sores in newborns and up to 8 years old children. Children admitted to Intensive care Units (ICU), oncology and neurology/neurosurgery wards are at risk of developing pressure sores. To validate the Italian version of the Braden Q scale for the assessment of the risk of developing pressure sores in children. Children from 21 days to 8 years, admitted to intensive and sub intensive units were recruited. Premature babies, children admitted with a pressure sore and with a story of congenital cardiomiopathy were excluded. In this cohort, multicentre and with repeated measurements study, the first assessment was performed after 24 hours from hospital admission, using the Braden Q Scale (Suddaby's version). The pressure sores were assessed with the Skin assessment Tool and staged according to the National Pressure Ulcer Advisory Panel. RESULTS. On the 157 children 524 observation were conducted. The incidence of pressure sores was 17.2%. Only the analysis on specific subgroups of patients showed a good diagnostic accuracy: 71.4% on children 3-8 years; 85.6% in sub intensive wards. The Braden Q scale may be reliably used and shows a good diagnostic accuracy in children 3-8 years of age admitted to sub-intensive, neurology, oncology and heamatology wards.

Development and Validation of a Novel Scoring System for Predicting Technical Success of Chronic Total Occlusion Percutaneous Coronary Interventions: The PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) Score.

PubMed

Christopoulos, Georgios; Kandzari, David E; Yeh, Robert W; Jaffer, Farouc A; Karmpaliotis, Dimitri; Wyman, Michael R; Alaswad, Khaldoon; Lombardi, William; Grantham, J Aaron; Moses, Jeffrey; Christakopoulos, Georgios; Tarar, Muhammad Nauman J; Rangan, Bavana V; Lembo, Nicholas; Garcia, Santiago; Cipher, Daisha; Thompson, Craig A; Banerjee, Subhash; Brilakis, Emmanouil S

2016-01-11

This study sought to develop a novel parsimonious score for predicting technical success of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) performed using the hybrid approach. Predicting technical success of CTO PCI can facilitate clinical decision making and procedural planning. We analyzed clinical and angiographic parameters from 781 CTO PCIs included in PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) using a derivation and validation cohort (2:1 sampling ratio). Variables with strong association with technical success in multivariable analysis were assigned 1 point, and a 4-point score was developed from summing all points. The PROGRESS CTO score was subsequently compared with the J-CTO (Multicenter Chronic Total Occlusion Registry in Japan) score in the validation cohort. Technical success was 92.9%. On multivariable analysis, factors associated with technical success included proximal cap ambiguity (beta coefficient [b] = 0.88), moderate/severe tortuosity (b = 1.18), circumflex artery CTO (b = 0.99), and absence of "interventional" collaterals (b = 0.88). The resulting score demonstrated good calibration and discriminatory capacity in the derivation (Hosmer-Lemeshow chi-square = 2.633; p = 0.268, and receiver-operator characteristic [ROC] area = 0.778) and validation (Hosmer-Lemeshow chi-square = 5.333; p = 0.070, and ROC area = 0.720) subset. In the validation cohort, the PROGRESS CTO and J-CTO scores performed similarly in predicting technical success (ROC area 0.720 vs. 0.746, area under the curve difference = 0.026, 95% confidence interval = -0.093 to 0.144). The PROGRESS CTO score is a novel useful tool for estimating technical success in CTO PCI performed using the hybrid approach. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Checklists for the Evaluation of Educational Software: Critical Review and Prospects.

ERIC Educational Resources Information Center

Tergan, Sigmar-Olaf

1998-01-01

Reviews strengths and weaknesses of check lists for the evaluation of computer software and outlines consequences for their practical application. Suggests an approach based on an instructional design model and a comprehensive framework to cope with problems of validity and predictive power of software evaluation. Discusses prospects of the…

A simple risk scoring system for prediction of relapse after inpatient alcohol treatment.

PubMed

Pedersen, Mads Uffe; Hesse, Morten

2009-01-01

Predicting relapse after alcoholism treatment can be useful in targeting patients for aftercare services. However, a valid and practical instrument for predicting relapse risk does not exist. Based on a prospective study of alcoholism treatment, we developed the Risk of Alcoholic Relapse Scale (RARS) using items taken from the Addiction Severity Index and some basic demographic information. The RARS was cross-validated using two non-overlapping samples, and tested for its ability to predict relapse across different models of treatment. The RARS predicted relapse to drinking within 6 months after alcoholism treatment in both the original and the validation sample, and in a second validation sample it predicted admission to new treatment 3 years after treatment. The RARS can identify patients at high risk of relapse who need extra aftercare and support after treatment.

Prediction of Incident Hypertension Within the Next Year: Prospective Study Using Statewide Electronic Health Records and Machine Learning

PubMed Central

Zhang, Yan; Wang, Oliver; Jin, Bo; Xia, Minjie; Liu, Modi; Zhou, Xin; Wu, Qian; Guo, Yanting; Zhu, Chunqing; Li, Yu-Ming; Culver, Devore S; Alfreds, Shaun T; Stearns, Frank; Sylvester, Karl G; Widen, Eric

2018-01-01

Background As a high-prevalence health condition, hypertension is clinically costly, difficult to manage, and often leads to severe and life-threatening diseases such as cardiovascular disease (CVD) and stroke. Objective The aim of this study was to develop and validate prospectively a risk prediction model of incident essential hypertension within the following year. Methods Data from individual patient electronic health records (EHRs) were extracted from the Maine Health Information Exchange network. Retrospective (N=823,627, calendar year 2013) and prospective (N=680,810, calendar year 2014) cohorts were formed. A machine learning algorithm, XGBoost, was adopted in the process of feature selection and model building. It generated an ensemble of classification trees and assigned a final predictive risk score to each individual. Results The 1-year incident hypertension risk model attained areas under the curve (AUCs) of 0.917 and 0.870 in the retrospective and prospective cohorts, respectively. Risk scores were calculated and stratified into five risk categories, with 4526 out of 381,544 patients (1.19%) in the lowest risk category (score 0-0.05) and 21,050 out of 41,329 patients (50.93%) in the highest risk category (score 0.4-1) receiving a diagnosis of incident hypertension in the following 1 year. Type 2 diabetes, lipid disorders, CVDs, mental illness, clinical utilization indicators, and socioeconomic determinants were recognized as driving or associated features of incident essential hypertension. The very high risk population mainly comprised elderly (age>50 years) individuals with multiple chronic conditions, especially those receiving medications for mental disorders. Disparities were also found in social determinants, including some community-level factors associated with higher risk and others that were protective against hypertension. Conclusions With statewide EHR datasets, our study prospectively validated an accurate 1-year risk prediction model for incident essential hypertension. Our real-time predictive analytic model has been deployed in the state of Maine, providing implications in interventions for hypertension and related diseases and hopefully enhancing hypertension care. PMID:29382633

Measuring Practicing and Prospective Elementary Teachers' Efficacy for Classroom Management: A Preliminary Development and Validation Study

ERIC Educational Resources Information Center

Putman, S. Michael

2013-01-01

Research has shown efficacy exerts a powerful influence on behavior. Classroom management represents one vehicle for demonstrations of these behaviors, yet few instruments focus solely on the measurement of this domain-specific form of efficacy. This research explored the relationship between teacher self-efficacy and classroom management through…

A risk score for the prediction of advanced age-related macular degeneration: Development and validation in 2 prospective cohorts

USDA-ARS?s Scientific Manuscript database

We aimed to develop an eye specific model which used readily available information to predict risk for advanced age-related macular degeneration (AMD). We used the Age-Related Eye Disease Study (AREDS) as our training dataset, which consisted of the 4,507 participants (contributing 1,185 affected v...

Emergency Department Triage of Traumatic Head Injury Using a Brain Electrical Activity Biomarker: A Multisite Prospective Observational Validation Trial.

PubMed

Hanley, Daniel; Prichep, Leslie S; Bazarian, Jeffrey; Huff, J Stephen; Naunheim, Rosanne; Garrett, John; Jones, Elizabeth B; Wright, David W; O'Neill, John; Badjatia, Neeraj; Gandhi, Dheeraj; Curley, Kenneth C; Chiacchierini, Richard; O'Neil, Brian; Hack, Dallas C

2017-05-01

A brain electrical activity biomarker for identifying traumatic brain injury (TBI) in emergency department (ED) patients presenting with high Glasgow Coma Scale (GCS) after sustaining a head injury has shown promise for objective, rapid triage. The main objective of this study was to prospectively evaluate the efficacy of an automated classification algorithm to determine the likelihood of being computed tomography (CT) positive, in high-functioning TBI patients in the acute state. Adult patients admitted to the ED for evaluation within 72 hours of sustaining a closed head injury with GCS 12 to 15 were candidates for study. A total of 720 patients (18-85 years) meeting inclusion/exclusion criteria were enrolled in this observational, prospective validation trial, at 11 U.S. EDs. GCS was 15 in 97%, with the first and third quartiles being 15 (interquartile range = 0) in the study population at the time of the evaluation. Standard clinical evaluations were conducted and 5 to 10 minutes of electroencephalogram (EEG) was acquired from frontal and frontal-temporal scalp locations. Using an a priori derived EEG-based classification algorithm developed on an independent population and applied to this validation population prospectively, the likelihood of each subject being CT+ was determined, and performance metrics were computed relative to adjudicated CT findings. Sensitivity of the binary classifier (likely CT+ or CT-) was 92.3% (95% confidence interval [CI] = 87.8%-95.5%) for detection of any intracranial injury visible on CT (CT+), with specificity of 51.6% (95% CI = 48.1%-55.1%) and negative predictive value (NPV) of 96.0% (95% CI = 93.2%-97.9%). Using ternary classification (likely CT+, equivocal, likely CT-) demonstrated enhanced sensitivity to traumatic hematomas (≥1 mL of blood), 98.6% (95% CI = 92.6%-100.0%), and NPV of 98.2% (95% CI = 95.5%-99.5%). Using an EEG-based biomarker high accuracy of predicting the likelihood of being CT+ was obtained, with high NPV and sensitivity to any traumatic bleeding and to hematomas. Specificity was significantly higher than standard CT decision rules. The short time to acquire results and the ease of use in the ED environment suggests that EEG-based classifier algorithms have potential to impact triage and clinical management of head-injured patients. © 2017 by the Society for Academic Emergency Medicine.

The needs of siblings of children with a life-threatening illness, part 2: Psychometric validation of the IBesFEMS.

PubMed

Olivier d'avignon, Marianne; Dumont, Serge; Valois, Pierre; Cohen, S Robin

2017-02-01

Life-threatening illnesses in children have a significant impact on the lives of their brothers and sisters. Consequently, special attention must be paid to the specific needs of these siblings to help them cope with their situations. To address this issue, we developed an inventory of the needs of the adolescent siblings of severely ill children, the Inventaire des Besoins de la Fratrie d'Enfants Malades Sévèrement (IBesFEMS) [Needs Inventory for Siblings of Critically Ill Children]. The present article describes a preliminary validation study of this new instrument. In a prospective cohort study, the 48-item instrument was administered via a website or paper to 58 siblings. Our study revealed that the measure has an estimated internal consistency of 0.96 and a temporal stability intraclass correlation coefficient (ICC) of 0.86 (p < 0.01). Its convergence validity is also satisfactory. Our findings suggest that the IBesFEMS is highly relevant for pediatric palliative care clinicians and researchers. Future studies should investigate its factorial structure and predictive validities.

Spectral mineral mapping for characterization of subtle geothermal prospects using ASTER data

NASA Astrophysics Data System (ADS)

Abubakar, A. J.; Hashim, M.; Pour, A. B.

2017-05-01

In this study, the performance of ASTER data is evaluated for mapping subtle geothermal prospects in an unexplored tropical region having a number of thermal springs. The study employed a simple Decorrelation stretch with specific absorptions to highlight possible alteration zones of interest related to Geothermal (GT) systems. Hydrothermal alteration minerals are subsequently mapped using Spectral Angle Mapper (SAM) and Linear Spectral Unmixing (LSU) algorithms to target representative minerals such as clays, carbonates and AL-OH minerals as indicators of GT activity. The results were validated through field GPS survey, rock sampling and laboratory analysis using latest smart lab X-Ray Diffractometer technology. The study indicates that ASTER broadband satellite data could be used to map subtle GT prospects with the aid of an in-situ verification. However, it also shows that ASTER could not discriminate within specie minerals especially for clays using SWIR bands. Subsequent studies are aimed at looking at both ASTER and Hyperion hyperspectral data in the same area as this could have significant implications for GT resource detection in unmapped aseismic and inaccessible tropical regions using available spaceborne data.

Validating a Local Failure Risk Stratification for Use in Prospective Studies of Adjuvant Radiation Therapy for Bladder Cancer

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

Baumann, Brian C.; He, Jiwei; Hwang, Wei-Ting

Purpose: To inform prospective trials of adjuvant radiation therapy (adj-RT) for bladder cancer after radical cystectomy, a locoregional failure (LF) risk stratification was proposed. This stratification was developed and validated using surgical databases that may not reflect the outcomes expected in prospective trials. Our purpose was to assess sources of bias that may affect the stratification model's validity or alter the LF risk estimates for each subgroup: time bias due to evolving surgical techniques; trial accrual bias due to inclusion of patients who would be ineligible for adj-RT trials because of early disease progression, death, or loss to follow-up shortlymore » after cystectomy; bias due to different statistical methods to estimate LF; and subgrouping bias due to different definitions of the LF subgroups. Methods and Materials: The LF risk stratification was developed using a single-institution cohort (n=442, 1990-2008) and the multi-institutional SWOG 8710 cohort (n=264, 1987-1998) treated with radical cystectomy with or without chemotherapy. We evaluated the sensitivity of the stratification to sources of bias using Fine-Gray regression and Kaplan-Meier analyses. Results: Year of radical cystectomy was not associated with LF risk on univariate or multivariate analysis after controlling for risk group. By use of more stringent inclusion criteria, 26 SWOG patients (10%) and 60 patients from the single-institution cohort (14%) were excluded. Analysis of the remaining patients confirmed 3 subgroups with significantly different LF risks with 3-year rates of 7%, 17%, and 36%, respectively (P<.01), nearly identical to the rates without correcting for trial accrual bias. Kaplan-Meier techniques estimated higher subgroup LF rates than competing risk analysis. The subgroup definitions used in the NRG-GU001 adj-RT trial were validated. Conclusions: These sources of bias did not invalidate the LF risk stratification or substantially change the model's LF estimates.« less

Children’s mental time travel during mind wandering

PubMed Central

Ye, Qun; Song, Xiaolan; Zhang, Yi; Wang, Qinqin

2014-01-01

The prospective bias is a salient feature of mind wandering in healthy adults, yet little is known about the temporal focus of children’s mind wandering. In the present study, (I) we developed the temporal focus of mind wandering questionnaire for school-age children (TFMWQ-C), a 12-item scale with good test–retest reliability and construct validity. (II) The criterion validity was tested by thought sampling in both choice reaction time task and working memory task. A positive correlation was found between the temporal focus measured by the questionnaire and the one adopted during task-unrelated thoughts (TUTs) by thought sampling probes, especially in the trait level of future-oriented mind wandering. At the same time, children who experienced more TUTs tended to show worse behavioral performance during tasks. (III) The children in both tasks experienced more future-oriented TUTs than past-oriented ones, which was congruent with the results observed in adults; however, in contrast with previous research on adults, the prospective bias was not influenced by task demands. Together these results indicate that the prospective bias of mind wandering has emerged since the school-age (9∼13 years old), and that the relationship between mental time travel (MTT) during mind wandering and the use of cognitive resources differs between children and adults. Our study provides new insights into how this interesting feature of mind wandering may adaptively contribute to the development of children’s MTT. PMID:25191301

Validation of physical activity instruments: Black Women's Health Study.

PubMed

Carter-Nolan, Pamela L; Adams-Campbell, Lucile L; Makambi, Kepher; Lewis, Shantell; Palmer, Julie R; Rosenberg, Lynn

2006-01-01

Few studies have reported on the validity of physical activity measures in African Americans. The present study was designed to determine the validity of a self-administered physical activity questionnaire (PAQ) that was used in a large prospective study of African American women in the United States against an accelerometer (actigraph), an objective assessment of movement, and a seven-day activity diary. The study was conducted among 101 women enrolled in the Black Women's Health Study (BWHS) cohort who resided in the Washington, DC, metropolitan area, representing 11.2% (101/900) of this sample. Physical activity levels were obtained from the parent BWHS PAQ (eg, 1997 and 1999) and repeated in the present study. This information entailed hours per week of participation in walking for exercise, hours per week of moderate activity (eg, housework, gardening, and bowling), and hours per week of strenuous activity (eg, basketball, swimming, running, and aerobics) during the previous year. The participants were required to wear actigraphs for seven days and then record their physical activities in their diaries (seven-day physical activity diary) during this time. The diaries were used to record the amount and pattern of daily energy expenditure. Significant positive correlations were seen between the BWHS PAQ and the actigraph for total activity, r=.28; walking, r=.26; and vigorous activity, r=.40, P<.001. For the seven-day physical activity diary, the BWHS PAQ also demonstrated significant correlations for total (r=0.42, P<.01); moderate (r=.26, P<.05); and vigorous activities (r=.41, P<.01). The BWHS PAQ is a useful measure of physical activity in the BWHS cohort and thus has utility in prospective epidemiologic research.

Clinical validation of prospective liquid biopsy monitoring in patients with wild-type RAS metastatic colorectal cancer treated with FOLFIRI-cetuximab

PubMed Central

Vega, Estela; Garralda, Elena; Alvarez, Rafael; de la Varga, Lisardo U.; Pascual, Jesús R.; Sánchez, Gema; Sarno, Francesca; Prieto, Susana H.; Perea, Sofía; Lopéz-Casas, Pedro P.; López-Ríos, Fernando; Hidalgo, Manuel

2017-01-01

Cancer genomics and translational medicine rely on the molecular profiling of patient's tumor obtained during surgery or biopsy. Alternatively, blood is a less invasive source of tumor DNA shed, amongst other ways, as cell-free DNA (cfDNA). Highly-sensitive assays capable to detect cancer genetic events from patient's blood plasma became popularly known as liquid biopsy (LqB). Importantly, retrospective studies including small number of selected patients with metastatic colorectal cancer (mCRC) patients treated with anti-EGFR therapy have shown LqB capable to detect the acquired clonal mutations in RAS genes leading to therapy resistance. However, the usefulness of LqB in the real-life clinical monitoring of these patients still lack additional validation on controlled studies. In this context, we designed a prospective LqB clinical trial to monitor newly diagnosed KRAS wild-type (wt) mCRC patients who received a standard FOLFIRI-cetuximab regimen. We used BEAMing technique for evaluate cfDNA mutations in KRAS, NRAS, BRAF, and PIK3CA in twenty-five patients during a 2-y period. A total of 2,178 cfDNA mutation analyses were performed and we observed that: a) continued wt circulating status was correlated with a prolonged response; b) smoldering increases in mutant cfDNA were correlated with acquired resistance; while c) mutation upsurge/explosion anticipated a remarkable clinical deterioration. The current study provides evidences, obtained for the first time in an unbiased and prospective manner, that reinforces the utility of LqB for monitoring mCRC patients. PMID:27852040

Clinical validation of prospective liquid biopsy monitoring in patients with wild-type RAS metastatic colorectal cancer treated with FOLFIRI-cetuximab.

PubMed

Toledo, Rodrigo A; Cubillo, Antonio; Vega, Estela; Garralda, Elena; Alvarez, Rafael; de la Varga, Lisardo U; Pascual, Jesús R; Sánchez, Gema; Sarno, Francesca; Prieto, Susana H; Perea, Sofía; Lopéz-Casas, Pedro P; López-Ríos, Fernando; Hidalgo, Manuel

2017-05-23

Cancer genomics and translational medicine rely on the molecular profiling of patient's tumor obtained during surgery or biopsy. Alternatively, blood is a less invasive source of tumor DNA shed, amongst other ways, as cell-free DNA (cfDNA). Highly-sensitive assays capable to detect cancer genetic events from patient's blood plasma became popularly known as liquid biopsy (LqB). Importantly, retrospective studies including small number of selected patients with metastatic colorectal cancer (mCRC) patients treated with anti-EGFR therapy have shown LqB capable to detect the acquired clonal mutations in RAS genes leading to therapy resistance. However, the usefulness of LqB in the real-life clinical monitoring of these patients still lack additional validation on controlled studies. In this context, we designed a prospective LqB clinical trial to monitor newly diagnosed KRAS wild-type (wt) mCRC patients who received a standard FOLFIRI-cetuximab regimen. We used BEAMing technique for evaluate cfDNA mutations in KRAS, NRAS, BRAF, and PIK3CA in twenty-five patients during a 2-y period. A total of 2,178 cfDNA mutation analyses were performed and we observed that: a) continued wt circulating status was correlated with a prolonged response; b) smoldering increases in mutant cfDNA were correlated with acquired resistance; while c) mutation upsurge/explosion anticipated a remarkable clinical deterioration. The current study provides evidences, obtained for the first time in an unbiased and prospective manner, that reinforces the utility of LqB for monitoring mCRC patients.

The IASLC Lung Cancer Staging Project: data elements for the prospective project.

PubMed

Giroux, Dorothy J; Rami-Porta, Ramón; Chansky, Kari; Crowley, John J; Groome, Patti A; Postmus, Pieter E; Rusch, Valerie; Sculier, Jean-Paul; Shepherd, Frances A; Sobin, Leslie; Goldstraw, Peter

2009-06-01

The International Association for the Study of Lung Cancer Retrospective Staging Project culminated in a series of recommendations to the International Union Against Cancer and to the American Joint Committee on Cancer regarding the seventh edition of the tumor, node, metastasis (TNM) classification for lung cancer. The International Staging Committee of the International Association for the Study of Lung Cancer now issues this call for participation in the Prospective Project designed to assess the validity of each component of T, N, and M, and other factors relevant to lung cancer staging and prognosis. In the Retrospective Project, the original data acquisition was typically motivated by interests other than staging. In contrast, the Prospective Project offers online data entry. Alternatively, participants may transfer existing data, provided core objectives are addressed. Cancer Research and Biostatistics will coordinate data management and analysis. The study population is newly diagnosed lung cancer patients. Data elements include patient characteristics, baseline laboratory values, first-line treatment, TNM plus supporting evidence, and survival. Pretreatment TNM will be collected for all cases; postsurgical TNM, if resection is attempted. T descriptors include size and degree of tumor extension, with further description of extent of visceral pleural invasion, venous invasion, carcinomatous lymphangitis, and pleural lavage cytology. M descriptors characterize the newly proposed M1a category and sites of distant metastases. Nodal station involvement is described by means of a newly proposed nodal map, facilitating international participation, and allowing further investigation of nodal zones. Successful collection and analysis of these data can be expected to yield unprecedented improvements in the utility and validity of lung cancer staging.

Recording Adverse Events Following Joint Arthroplasty: Financial Implications and Validation of an Adverse Event Assessment Form.

PubMed

Lee, Matthew J; Mohamed, Khalid M S; Kelly, John C; Galbraith, John G; Street, John; Lenehan, Brian J

2017-09-01

In Ireland, funding of joint arthroplasty procedures has moved to a pay-by-results national tariff system. Typically, adverse clinical events are recorded via retrospective chart-abstraction methods by administrative staff. Missed or undocumented events not only affect the quality of patient care but also may unrealistically skew budgetary decisions that impact fiscal viability of the service. Accurate recording confers clinical benefits and financial transparency. The aim of this study was to compare a prospectively implemented adverse events form with the current national retrospective chart-abstraction method in terms of pay-by-results financial implications. An adverse events form adapted from a similar validated model was used to prospectively record complications in 51 patients undergoing total hip or knee arthroplasties. Results were compared with the same cohort using an existing data abstraction method. Both data sets were coded in accordance with current standards for case funding. Overall, 114 events were recorded during the study through prospective charting of adverse events, compared with 15 events documented by customary method (a significant discrepancy). Wound drainage (15.8%) was the most common complication, followed by anemia (7.9%), lower respiratory tract infections (7.9%), and cardiac events (7%). A total of €61,956 ($67,778) in missed funding was calculated as a result. This pilot study demonstrates the ability to improve capture of adverse events through use of a well-designed assessment form. Proper perioperative data handling is a critical aspect of financial subsidies, enabling optimal allocation of funds. Copyright © 2017 Elsevier Inc. All rights reserved.

The validity of student tutors' judgments in early detection of struggling in medical school. A prospective cohort study.

PubMed

O'Neill, Lotte Dyhrberg; Morcke, Anne Mette; Eika, Berit

2016-12-01

Early identification and support of strugglers in medical education is generally recommended in the research literature, though very little evidence of the diagnostic qualities of early teacher judgments in medical education currently exists. The aim of this study was to examine the validity of early diagnosis of struggling in medical school based on informal teacher judgements of in-class behavior. The study design was a prospective cohort study and the outcomes/truth criteria were anatomy failure and medical school drop out. Six weeks into an anatomy course, student tutors attempted to identify medical students, who they reckoned would fail the anatomy course or drop out, based on their everyday experiences with students in a large group educational setting. In addition, they were asked to describe the indicators of struggling they observed. Sixteen student tutors evaluated 429 medical students for signs of struggling. By week six, the student tutors were able to detect approximately 1/4-1/3 of the students who eventually failed or dropped out, and for ¾ of the strugglers they identified, they were correct in their judgments. Informal student tutor's judgements showed incremental validity for both outcomes when controlling for grades obtained in preceeding exams. Lack of participation, lack of commitment, poor academic performance, poor social interactions and general signs of distress were the main indicators of struggling identified. Teachers' informal judgements of in-class behavior may be an untapped source of information in the early identification of struggling medical students with added value above and beyond formal testing.

Open source posturography.

PubMed

Rey-Martinez, Jorge; Pérez-Fernández, Nicolás

2016-12-01

The proposed validation goal of 0.9 in intra-class correlation coefficient was reached with the results of this study. With the obtained results we consider that the developed software (RombergLab) is a validated balance assessment software. The reliability of this software is dependent of the used force platform technical specifications. Develop and validate a posturography software and share its source code in open source terms. Prospective non-randomized validation study: 20 consecutive adults underwent two balance assessment tests, six condition posturography was performed using a clinical approved software and force platform and the same conditions were measured using the new developed open source software using a low cost force platform. Intra-class correlation index of the sway area obtained from the center of pressure variations in both devices for the six conditions was the main variable used for validation. Excellent concordance between RombergLab and clinical approved force platform was obtained (intra-class correlation coefficient =0.94). A Bland and Altman graphic concordance plot was also obtained. The source code used to develop RombergLab was published in open source terms.

Video games and youth violence: a prospective analysis in adolescents.

PubMed

Ferguson, Christopher J

2011-04-01

The potential influence of violent video games on youth violence remains an issue of concern for psychologists, policymakers and the general public. Although several prospective studies of video game violence effects have been conducted, none have employed well validated measures of youth violence, nor considered video game violence effects in context with other influences on youth violence such as family environment, peer delinquency, and depressive symptoms. The current study builds upon previous research in a sample of 302 (52.3% female) mostly Hispanic youth. Results indicated that current levels of depressive symptoms were a strong predictor of serious aggression and violence across most outcome measures. Depressive symptoms also interacted with antisocial traits so that antisocial individuals with depressive symptoms were most inclined toward youth violence. Neither video game violence exposure, nor television violence exposure, were prospective predictors of serious acts of youth aggression or violence. These results are put into the context of criminological data on serious acts of violence among youth.

Measuring childhood maltreatment to predict early-adult psychopathology: Comparison of prospective informant-reports and retrospective self-reports.

PubMed

Newbury, Joanne B; Arseneault, Louise; Moffitt, Terrie E; Caspi, Avshalom; Danese, Andrea; Baldwin, Jessie R; Fisher, Helen L

2018-01-01

Both prospective informant-reports and retrospective self-reports may be used to measure childhood maltreatment, though both methods entail potential limitations such as underestimation and memory biases. The validity and utility of standard measures of childhood maltreatment requires clarification in order to inform the design of future studies investigating the mental health consequences of maltreatment. The present study assessed agreement between prospective informant-reports and retrospective self-reports of childhood maltreatment, as well as the comparative utility of both reports for predicting a range of psychiatric problems at age 18. Data were obtained from the Environmental Risk (E-Risk) Longitudinal Twin Study, a nationally-representative birth cohort of 2232 children followed to 18 years of age (with 93% retention). Childhood maltreatment was assessed in two ways: (i) prospective informant-reports from caregivers, researchers, and clinicians when children were aged 5, 7, 10 and 12; and (ii) retrospective self-reports of maltreatment experiences occurring up to age 12, obtained at age 18 using the Childhood Trauma Questionnaire. Participants were privately interviewed at age 18 concerning several psychiatric problems including depression, anxiety, self-injury, alcohol/cannabis dependence, and conduct disorder. There was only slight to fair agreement between prospective and retrospective reports of childhood maltreatment (all Kappa's ≤ 0.31). Both prospective and retrospective reports of maltreatment were associated with age-18 psychiatric problems, though the strongest associations were found when maltreatment was retrospectively self-reported. These findings indicate that prospective and retrospective reports of childhood maltreatment capture largely non-overlapping groups of individuals. Young adults who recall being maltreated have a particularly elevated risk for psychopathology. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Applications of Data Mining Methods in the Integrative Medical Studies of Coronary Heart Disease: Progress and Prospect

PubMed Central

Wang, Yixin; Guo, Fang

2014-01-01

A large amount of studies show that real-world study has strong external validity than the traditional randomized controlled trials and can evaluate the effect of interventions in a real clinical setting, which open up a new path for researches of integrative medicine in coronary heart disease. However, clinical data of integrative medicine in coronary heart disease are large in amount and complex in data types, making exploring the appropriate methodology a hot topic. Data mining techniques are to analyze and dig out useful information and knowledge from the mass data to guide people's practices. The present review provides insights for the main features of data mining and their applications of integrative medical studies in coronary heart disease, aiming to analyze the progress and prospect in this field. PMID:25544853

Psychometric Arabic Sino-Nasal Outcome Test-22: validation and translation in chronic rhinosinusitis patients.

PubMed

Alanazy, Fatma; Dousary, Surayie Al; Albosaily, Ahmed; Aldriweesh, Turki; Alsaleh, Saad; Aldrees, Turki

2018-01-01

The Sino-Nasal Outcome Test (SNOT)-22 has multiple items that reflect how nasal disease affects quality of life. Currently, no validated Arabic version of the SNOT-22 is available. . To develop an Arabic-validated version of SNOT-22. Prospective. Tertiary care center. This single-center validation study was conducted between 2015 and 2017 at King Abdul-Aziz University Hospital, Riyadh, Saudi Arabia. The SNOT-22 English version was translated into Arabic by the forward and backward method. The test and retest reliability, internal consistency, responsiveness to surgical treatment, discriminant validity, sensitivity and specificity all were tested. Validated Arabic version of the SNOT-22. Of 265 individuals, 171 were healthy volunteers and 94 were chronic rhinosinusitis patients. The Arabic version showed high internal consistency (Cronbach's of 0.94), and the ability to differentiate between diseased and healthy volunteers (P < .001). The translated versions demonstrated the ability to detect the change scores significantly in response to intervention (P < .001). This is the first validated Arabic version of SNOT-22. The instrument can be used among the Arabic population. No subjects from other Arab countries.

In silico target prediction for elucidating the mode of action of herbicides including prospective validation.

PubMed

Chiddarwar, Rucha K; Rohrer, Sebastian G; Wolf, Antje; Tresch, Stefan; Wollenhaupt, Sabrina; Bender, Andreas

2017-01-01

The rapid emergence of pesticide resistance has given rise to a demand for herbicides with new mode of action (MoA). In the agrochemical sector, with the availability of experimental high throughput screening (HTS) data, it is now possible to utilize in silico target prediction methods in the early discovery phase to suggest the MoA of a compound via data mining of bioactivity data. While having been established in the pharmaceutical context, in the agrochemical area this approach poses rather different challenges, as we have found in this work, partially due to different chemistry, but even more so due to different (usually smaller) amounts of data, and different ways of conducting HTS. With the aim to apply computational methods for facilitating herbicide target identification, 48,000 bioactivity data against 16 herbicide targets were processed to train Laplacian modified Naïve Bayesian (NB) classification models. The herbicide target prediction model ("HerbiMod") is an ensemble of 16 binary classification models which are evaluated by internal, external and prospective validation sets. In addition to the experimental inactives, 10,000 random agrochemical inactives were included in the training process, which showed to improve the overall balanced accuracy of our models up to 40%. For all the models, performance in terms of balanced accuracy of≥80% was achieved in five-fold cross validation. Ranking target predictions was addressed by means of z-scores which improved predictivity over using raw scores alone. An external testset of 247 compounds from ChEMBL and a prospective testset of 394 compounds from BASF SE tested against five well studied herbicide targets (ACC, ALS, HPPD, PDS and PROTOX) were used for further validation. Only 4% of the compounds in the external testset lied in the applicability domain and extrapolation (and correct prediction) was hence impossible, which on one hand was surprising, and on the other hand illustrated the utilization of using applicability domains in the first place. However, performance better than 60% in balanced accuracy was achieved on the prospective testset, where all the compounds fell within the applicability domain, and which hence underlines the possibility of using target prediction also in the area of agrochemicals. Copyright © 2016 Elsevier Inc. All rights reserved.

Validation of the Ottawa Knee Rules.

PubMed

Emparanza, J I; Aginaga, J R

2001-10-01

We sought to validate the Ottawa Knee Rules for determining the need for radiography in patients with acute knee injury. A prospective cohort study was performed in emergency departments of 11 hospitals of the Osakidetza-Basque Country Health Service. The patient population was composed of a convenience sample of 1,522 eligible adults of 2,315 patients with acute knee injuries. The attending emergency physicians assessed each patient for standardized clinical variables and determined the need for radiography according to the decision rule. Radiography was performed in each patient, irrespective of the determination of the rule, after clinical evaluation findings were recorded. The rule was assessed for the ability to correctly identify fracture of the knee. The decision rule had a sensitivity of 1.0 (95% confidence interval [CI] 0.96 to 1.0), identifying 89 patients with clinically important fractures. The potential reduction in use of radiography was estimated to be 49%. The probability of fracture, if the decision rules were negative, is estimated to be 0% (95% CI 0% to 0.5%). Prospective validation has shown the Ottawa Knee Rules to be 100% sensitive for identifying fractures of the knee and to have the potential to allow physicians to reduce the use of radiography in patients with acute knee injuries.

The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design

PubMed Central

Du, Xue; Pi, Yi; Dreyer, Rachel P.; Li, Jing; Li, Xi; Downing, Nicholas S.; Li, Li; Feng, Fang; Zhan, Lijuan; Zhang, Haibo; Guan, Wenchi; Xu, Xiao; Li, Shu‐Xia; Lin, Zhenqiu; Masoudi, Frederick A.; Spertus, John A.; Krumholz, Harlan M.

2016-01-01

Background The number of percutaneous coronary interventions (PCI) in China has increased more than 20‐fold over the last decade. Consequently, there is a need for national‐level information to characterize PCI indications and long‐term patient outcomes, including health status, to understand and improve evolving practice patterns. Objectives: This nationwide prospective study of patients receiving PCI is to: (1) measure long‐term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient‐reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient‐ and hospital‐level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. Methods: The China Patient‐centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012–2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in‐hospital outcomes from medical charts, and conducted baseline, 1‐, 6‐, and 12‐month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12‐month follow‐up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. Conclusion: China PEACE Prospective Study of PCI will be the first study to generate novel, high‐quality, comprehensive national data on patients’ socio‐demographic, clinical, treatment, and metabolic/genetic factors, and importantly, their long‐term outcomes following PCI, including health status. This will build the foundation for PCI performance improvement efforts in China. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc. PMID:26945565

The china patient-centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design.

PubMed

Du, Xue; Pi, Yi; Dreyer, Rachel P; Li, Jing; Li, Xi; Downing, Nicholas S; Li, Li; Feng, Fang; Zhan, Lijuan; Zhang, Haibo; Guan, Wenchi; Xu, Xiao; Li, Shu-Xia; Lin, Zhenqiu; Masoudi, Frederick A; Spertus, John A; Krumholz, Harlan M; Jiang, Lixin

2016-12-01

The number of percutaneous coronary interventions (PCI) in China has increased more than 20-fold over the last decade. Consequently, there is a need for national-level information to characterize PCI indications and long-term patient outcomes, including health status, to understand and improve evolving practice patterns. This nationwide prospective study of patients receiving PCI is to: (1) measure long-term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient-reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient- and hospital-level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012-2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in-hospital outcomes from medical charts, and conducted baseline, 1-, 6-, and 12-month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12-month follow-up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. China PEACE Prospective Study of PCI will be the first study to generate novel, high-quality, comprehensive national data on patients' socio-demographic, clinical, treatment, and metabolic/genetic factors, and importantly, their long-term outcomes following PCI, including health status. This will build the foundation for PCI performance improvement efforts in China. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc.

Association of High-Density Lipoprotein-Cholesterol Versus Apolipoprotein A-I With Risk of Coronary Heart Disease: The European Prospective Investigation Into Cancer-Norfolk Prospective Population Study, the Atherosclerosis Risk in Communities Study, and the Women's Health Study.

PubMed

van Capelleveen, Julian C; Bochem, Andrea E; Boekholdt, S Matthijs; Mora, Samia; Hoogeveen, Ron C; Ballantyne, Christie M; Ridker, Paul M; Sun, Wensheng; Barter, Philip J; Tall, Alan R; Zwinderman, Aeilko H; Kastelein, John J P; Wareham, Nick J; Khaw, Kay-Tee; Hovingh, G Kees

2017-08-03

The contribution of apolipoprotein A-I (apoA-I) to coronary heart disease (CHD) risk stratification over and above high-density lipoprotein cholesterol (HDL-C) is unclear. We studied the associations between plasma levels of HDL-C and apoA-I, either alone or combined, with risk of CHD events and cardiovascular risk factors among apparently healthy men and women. HDL-C and apoA-I levels were measured among 17 661 participants of the EPIC (European Prospective Investigation into Cancer)-Norfolk prospective population study. Hazard ratios for CHD events and distributions of risk factors were calculated by quartiles of HDL-C and apoA-I. Results were validated using data from the ARIC (Atherosclerosis Risk in Communities) and WHS (Women's Health Study) cohorts, comprising 15 494 and 27 552 individuals, respectively. In EPIC-Norfolk, both HDL-C and apoA-I quartiles were strongly and inversely associated with CHD risk. Within HDL-C quartiles, higher apoA-I levels were not associated with lower CHD risk; in fact, CHD risk was higher within some HDL-C quartiles. ApoA-I levels were associated with higher levels of CHD risk factors: higher body mass index, HbA1c, non-HDL-C, triglycerides, apolipoprotein B, systolic blood pressure, and C-reactive protein, within fixed HDL-C quartiles. In contrast, HDL-C levels were consistently inversely associated with overall CHD risk and CHD risk factors within apoA-I quartiles ( P <0.001). These findings were validated in the ARIC and WHS cohorts. Our findings demonstrate that apoA-I levels do not offer predictive information over and above HDL-C. In fact, within some HDL-C quartiles, higher apoA-I levels were associated with higher risk of CHD events, possibly because of the unexpected higher prevalence of cardiovascular risk factors in association with higher apoA-I levels. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00000479. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study

PubMed Central

Wotherspoon, Lisa M; Boyd, Kathleen Anne; Morris, Rachel K; Jackson, Lesley; Chandiramani, Manju; David, Anna L; Khalil, Asma; Shennan, Andrew; Hodgetts Morton, Victoria; Lavender, Tina; Khan, Khalid; Harper-Clarke, Susan; Mol, Ben; Riley, Richard D; Norrie, John; Norman, Jane

2018-01-01

Introduction The aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using quantitative fetal fibronectin (fFN) concentration, in combination with clinical risk factors. Methods and analysis The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts, USA) which quantifies fFN in a vaginal swab. In QUIDS part 2, we will perform a prospective cohort study in at least eight UK consultant-led maternity units, in women with symptoms of preterm labour at 22+0 to 34+6 weeks gestation to externally validate a prognostic model developed in QUIDS part 1. The effects of quantitative fFN on anxiety will be assessed, and acceptability of the test and prognostic model will be evaluated in a subgroup of women and clinicians (n=30). The sample size is 1600 women (with estimated 96–192 events of preterm delivery within 7 days of testing). Clinicians will be informed of the qualitative fFN result (positive/negative) but be blinded to quantitative fFN result. Research midwives will collect outcome data from the maternal and neonatal clinical records. The final validated prognostic model will be presented as a mobile or web-based application. Ethics and dissemination The study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14/32/01). It has been approved by the West of Scotland Research Ethics Committee (16/WS/0068). Version Protocol V.2, Date 1 November 2016. Trial registration number ISRCTN41598423 and CPMS: 31277. PMID:29674373

Analysis of expert validation on developing integrated science worksheet to improve problem solving skills of natural science prospective teachers

NASA Astrophysics Data System (ADS)

Widodo, W.; Sudibyo, E.; Sari, D. A. P.

2018-04-01

This study aims to develop student worksheets for higher education that apply integrated science learning in discussing issues about motion in humans. These worksheets will guide students to solve the problem about human movement. They must integrate their knowledge about biology, physics, and chemistry to solve the problem. The worksheet was validated by three experts in Natural Science Integrated Science, especially in Human Movement topic. The aspects of the validation were feasibility of the content, the construction, and the language. This research used the Likert scale to measure the validity of each aspect, which is 4.00 for very good validity criteria, 3.00 for good validity criteria, 2.00 for more or less validity criteria, and 1.00 for not good validity criteria. Data showed that the validity for each aspect were in the range of good validity and very good validity criteria (3.33 to 3.67 for the content aspect, 2.33 to 4.00 for the construction aspect, and 3.33 to 4.00 for language aspect). However, there was a part of construction aspect that needed to improve. Overall, this students’ worksheet can be applied in classroom after some revisions based on suggestions from the validators.

The development and testing of a skin tear risk assessment tool.

PubMed

Newall, Nelly; Lewin, Gill F; Bulsara, Max K; Carville, Keryln J; Leslie, Gavin D; Roberts, Pam A

2017-02-01

The aim of the present study is to develop a reliable and valid skin tear risk assessment tool. The six characteristics identified in a previous case control study as constituting the best risk model for skin tear development were used to construct a risk assessment tool. The ability of the tool to predict skin tear development was then tested in a prospective study. Between August 2012 and September 2013, 1466 tertiary hospital patients were assessed at admission and followed up for 10 days to see if they developed a skin tear. The predictive validity of the tool was assessed using receiver operating characteristic (ROC) analysis. When the tool was found not to have performed as well as hoped, secondary analyses were performed to determine whether a potentially better performing risk model could be identified. The tool was found to have high sensitivity but low specificity and therefore have inadequate predictive validity. Secondary analysis of the combined data from this and the previous case control study identified an alternative better performing risk model. The tool developed and tested in this study was found to have inadequate predictive validity. The predictive validity of an alternative, more parsimonious model now needs to be tested. © 2015 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Validation of the CoRE Questionnaire for a Medical Journal Peer Review.

PubMed

Doi, Suhail A R; Salzman-Scott, Sherry A; Onitilo, Adedayo A

2016-01-01

If a peer review instrument asks concrete questions (defined as items that can only generate disagreement if reviewers have different degrees of expertise), then questionnaires could become more meaningful in terms of resolving subjectivity thus leading to more reviewer agreement. A concrete item questionnaire with well-chosen questions can also help resolve disagreement when reviewers have the same level of expertise. We have recently created the core-item reviewer evaluation (CoRE) questionnaire for which decision-threshold score levels have been created, but which have not been validated. This prospective validation of these thresholds for the CoRE questionnaire demonstrated strong agreement between reviewer recommendations and their reported score levels when tested prospectively at Clinical Medicine and Research. We conclude that using the CoRE questionnaire will help reduce peer reviewer disagreement. More importantly, when reviewer expertise varies, editors can more easily detect this and decide which opinion reflects the greater expertise.

Hybrid surgery-radiosurgery therapy for metastatic epidural spinal cord compression: A prospective evaluation using patient-reported outcomes.

PubMed

Barzilai, Ori; Amato, Mary-Kate; McLaughlin, Lily; Reiner, Anne S; Ogilvie, Shahiba Q; Lis, Eric; Yamada, Yoshiya; Bilsky, Mark H; Laufer, Ilya

2018-05-01

Patient-reported outcomes (PRO) represent an important measure of cancer therapy effect. For patients with metastatic epidural spinal cord compression (MESCC), hybrid therapy using separation surgery and stereotactic radiosurgery preserves neurologic function and provides tumor control. There is currently a paucity of data reporting PRO after such combined modality therapy for MESCC. Delineation of hybrid surgery-radiosurgery therapy effect on PRO validates the hybrid approach as an effective therapy resulting in meaningful symptom relief. Brief Pain Inventory (BPI) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP), PROs validated in the cancer population, were prospectively collected. Patients with MESCC who underwent separation surgery followed by stereotactic radiosurgery were included. Separation surgery included a posterolateral approach without extensive cytoreductive tumor excision. A median postoperative radiosurgery dose of 2700 cGy was delivered. The change in PRO 3 months after the hybrid therapy represented the primary study outcome. Preoperative and postoperative evaluations were analyzed using the Wilcoxon signed-rank test for matched pairs. One hundred eleven patients were included. Hybrid therapy resulted in a significant reduction in the BPI items "worst" and "right now" pain ( P < .0001), and in all BPI constructs (severity, interference with daily activities, and pain experience, P < .001). The MDASI-SP demonstrated reduction in spine-specific pain severity and interference with general activity ( P < .001), along with decreased symptom interference ( P < .001). Validated PRO instruments showed that in patients with MESCC, hybrid therapy with separation surgery and radiosurgery results in a significant decrease in pain severity and symptom interference. These prospective data confirm the benefit of hybrid therapy for treatment of MESCC and should facilitate referral of patients with MESCC for surgical evaluation.

Multicentre prospective validation of a urinary peptidome-based classifier for the diagnosis of type 2 diabetic nephropathy

PubMed Central

Siwy, Justyna; Schanstra, Joost P.; Argiles, Angel; Bakker, Stephan J.L.; Beige, Joachim; Boucek, Petr; Brand, Korbinian; Delles, Christian; Duranton, Flore; Fernandez-Fernandez, Beatriz; Jankowski, Marie-Luise; Al Khatib, Mohammad; Kunt, Thomas; Lajer, Maria; Lichtinghagen, Ralf; Lindhardt, Morten; Maahs, David M; Mischak, Harald; Mullen, William; Navis, Gerjan; Noutsou, Marina; Ortiz, Alberto; Persson, Frederik; Petrie, John R.; Roob, Johannes M.; Rossing, Peter; Ruggenenti, Piero; Rychlik, Ivan; Serra, Andreas L.; Snell-Bergeon, Janet; Spasovski, Goce; Stojceva-Taneva, Olivera; Trillini, Matias; von der Leyen, Heiko; Winklhofer-Roob, Brigitte M.; Zürbig, Petra; Jankowski, Joachim

2014-01-01

Background Diabetic nephropathy (DN) is one of the major late complications of diabetes. Treatment aimed at slowing down the progression of DN is available but methods for early and definitive detection of DN progression are currently lacking. The ‘Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria trial’ (PRIORITY) aims to evaluate the early detection of DN in patients with type 2 diabetes (T2D) using a urinary proteome-based classifier (CKD273). Methods In this ancillary study of the recently initiated PRIORITY trial we aimed to validate for the first time the CKD273 classifier in a multicentre (9 different institutions providing samples from 165 T2D patients) prospective setting. In addition we also investigated the influence of sample containers, age and gender on the CKD273 classifier. Results We observed a high consistency of the CKD273 classification scores across the different centres with areas under the curves ranging from 0.95 to 1.00. The classifier was independent of age (range tested 16–89 years) and gender. Furthermore, the use of different urine storage containers did not affect the classification scores. Analysis of the distribution of the individual peptides of the classifier over the nine different centres showed that fragments of blood-derived and extracellular matrix proteins were the most consistently found. Conclusion We provide for the first time validation of this urinary proteome-based classifier in a multicentre prospective setting and show the suitability of the CKD273 classifier to be used in the PRIORITY trial. PMID:24589724

A Two-Biomarker Model Predicts Mortality in the Critically Ill with Sepsis.

PubMed

Mikacenic, Carmen; Price, Brenda L; Harju-Baker, Susanna; O'Mahony, D Shane; Robinson-Cohen, Cassianne; Radella, Frank; Hahn, William O; Katz, Ronit; Christiani, David C; Himmelfarb, Jonathan; Liles, W Conrad; Wurfel, Mark M

2017-10-15

Improving the prospective identification of patients with systemic inflammatory response syndrome (SIRS) and sepsis at low risk for organ dysfunction and death is a major clinical challenge. To develop and validate a multibiomarker-based prediction model for 28-day mortality in critically ill patients with SIRS and sepsis. A derivation cohort (n = 888) and internal test cohort (n = 278) were taken from a prospective study of critically ill intensive care unit (ICU) patients meeting two of four SIRS criteria at an academic medical center for whom plasma was obtained within 24 hours. The validation cohort (n = 759) was taken from a prospective cohort enrolled at another academic medical center ICU for whom plasma was obtained within 48 hours. We measured concentrations of angiopoietin-1, angiopoietin-2, IL-6, IL-8, soluble tumor necrosis factor receptor-1, soluble vascular cell adhesion molecule-1, granulocyte colony-stimulating factor, and soluble Fas. We identified a two-biomarker model in the derivation cohort that predicted mortality (area under the receiver operator characteristic curve [AUC], 0.79; 95% confidence interval [CI], 0.74-0.83). It performed well in the internal test cohort (AUC, 0.75; 95% CI, 0.65-0.85) and the external validation cohort (AUC, 0.77; 95% CI, 0.72-0.83). We determined a model score threshold demonstrating high negative predictive value (0.95) for death. In addition to a low risk of death, patients below this threshold had shorter ICU length of stay, lower incidence of acute kidney injury, acute respiratory distress syndrome, and need for vasopressors. We have developed a simple, robust biomarker-based model that identifies patients with SIRS/sepsis at low risk for death and organ dysfunction.

External validation of the DHAKA score and comparison with the current IMCI algorithm for the assessment of dehydration in children with diarrhoea: a prospective cohort study.

PubMed

Levine, Adam C; Glavis-Bloom, Justin; Modi, Payal; Nasrin, Sabiha; Atika, Bita; Rege, Soham; Robertson, Sarah; Schmid, Christopher H; Alam, Nur H

2016-10-01

Dehydration due to diarrhoea is a leading cause of child death worldwide, yet no clinical tools for assessing dehydration have been validated in resource-limited settings. The Dehydration: Assessing Kids Accurately (DHAKA) score was derived for assessing dehydration in children with diarrhoea in a low-income country setting. In this study, we aimed to externally validate the DHAKA score in a new population of children and compare its accuracy and reliability to the current Integrated Management of Childhood Illness (IMCI) algorithm. DHAKA was a prospective cohort study done in children younger than 60 months presenting to the International Centre for Diarrhoeal Disease Research, Bangladesh, with acute diarrhoea (defined by WHO as three or more loose stools per day for less than 14 days). Local nurses assessed children and classified their dehydration status using both the DHAKA score and the IMCI algorithm. Serial weights were obtained and dehydration status was established by percentage weight change with rehydration. We did regression analyses to validate the DHAKA score and compared the accuracy and reliability of the DHAKA score and IMCI algorithm with receiver operator characteristic (ROC) curves and the weighted κ statistic. This study was registered with ClinicalTrials.gov, number NCT02007733. Between March 22, 2015, and May 15, 2015, 496 patients were included in our primary analyses. On the basis of our criterion standard, 242 (49%) of 496 children had no dehydration, 184 (37%) of 496 had some dehydration, and 70 (14%) of 496 had severe dehydration. In multivariable regression analyses, each 1-point increase in the DHAKA score predicted an increase of 0·6% in the percentage dehydration of the child and increased the odds of both some and severe dehydration by a factor of 1·4. Both the accuracy and reliability of the DHAKA score were significantly greater than those of the IMCI algorithm. The DHAKA score is the first clinical tool for assessing dehydration in children with acute diarrhoea to be externally validated in a low-income country. Further validation studies in a diverse range of settings and paediatric populations are warranted. National Institutes of Health Fogarty International Center. Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

External validation of the DHAKA score and comparison with the current IMCI algorithm for the assessment of dehydration in children with diarrhoea: a prospective cohort study

PubMed Central

Levine, Adam C; Glavis-Bloom, Justin; Modi, Payal; Nasrin, Sabiha; Atika, Bita; Rege, Soham; Robertson, Sarah; Schmid, Christopher H; Alam, Nur H

2016-01-01

Summary Background Dehydration due to diarrhoea is a leading cause of child death worldwide, yet no clinical tools for assessing dehydration have been validated in resource-limited settings. The Dehydration: Assessing Kids Accurately (DHAKA) score was derived for assessing dehydration in children with diarrhoea in a low-income country setting. In this study, we aimed to externally validate the DHAKA score in a new population of children and compare its accuracy and reliability to the current Integrated Management of Childhood Illness (IMCI) algorithm. Methods DHAKA was a prospective cohort study done in children younger than 60 months presenting to the International Centre for Diarrhoeal Disease Research, Bangladesh, with acute diarrhoea (defined by WHO as three or more loose stools per day for less than 14 days). Local nurses assessed children and classified their dehydration status using both the DHAKA score and the IMCI algorithm. Serial weights were obtained and dehydration status was established by percentage weight change with rehydration. We did regression analyses to validate the DHAKA score and compared the accuracy and reliability of the DHAKA score and IMCI algorithm with receiver operator characteristic (ROC) curves and the weighted κ statistic. This study was registered with ClinicalTrials.gov, number NCT02007733. Findings Between March 22, 2015, and May 15, 2015, 496 patients were included in our primary analyses. On the basis of our criterion standard, 242 (49%) of 496 children had no dehydration, 184 (37%) of 496 had some dehydration, and 70 (14%) of 496 had severe dehydration. In multivariable regression analyses, each 1-point increase in the DHAKA score predicted an increase of 0·6% in the percentage dehydration of the child and increased the odds of both some and severe dehydration by a factor of 1·4. Both the accuracy and reliability of the DHAKA score were significantly greater than those of the IMCI algorithm. Interpretation The DHAKA score is the first clinical tool for assessing dehydration in children with acute diarrhoea to be externally validated in a low-income country. Further validation studies in a diverse range of settings and paediatric populations are warranted. Funding National Institutes of Health Fogarty International Center. PMID:27567350

Assessing the Rigor of HS Curriculum in Admissions Decisions: A Functional Method, Plus Practical Advising for Prospective Students and High School Counselors

ERIC Educational Resources Information Center

Micceri, Theodore; Brigman, Leellen; Spatig, Robert

2009-01-01

An extensive, internally cross-validated analytical study using nested (within academic disciplines) Multilevel Modeling (MLM) on 4,560 students identified functional criteria for defining high school curriculum rigor and further determined which measures could best be used to help guide decision making for marginal applicants. The key outcome…

Group-level self-definition and self-investment: a hierarchical (multicomponent) model of in-group identification.

PubMed

Leach, Colin Wayne; van Zomeren, Martijn; Zebel, Sven; Vliek, Michael L W; Pennekamp, Sjoerd F; Doosje, Bertjan; Ouwerkerk, Jaap W; Spears, Russell

2008-07-01

Recent research shows individuals' identification with in-groups to be psychologically important and socially consequential. However, there is little agreement about how identification should be conceptualized or measured. On the basis of previous work, the authors identified 5 specific components of in-group identification and offered a hierarchical 2-dimensional model within which these components are organized. Studies 1 and 2 used confirmatory factor analysis to validate the proposed model of self-definition (individual self-stereotyping, in-group homogeneity) and self-investment (solidarity, satisfaction, and centrality) dimensions, across 3 different group identities. Studies 3 and 4 demonstrated the construct validity of the 5 components by examining their (concurrent) correlations with established measures of in-group identification. Studies 5-7 demonstrated the predictive and discriminant validity of the 5 components by examining their (prospective) prediction of individuals' orientation to, and emotions about, real intergroup relations. Together, these studies illustrate the conceptual and empirical value of a hierarchical multicomponent model of in-group identification.

Are loss of control while eating and overeating valid constructs? A critical review of the literature

PubMed Central

Goldschmidt, Andrea B.

2017-01-01

Background Binge eating is a marker of weight gain and obesity, and a hallmark feature of eating disorders. Yet, its component constructs—overeating and loss of control (LOC) while eating—are poorly understood and difficult to measure. Objective To critically review the human literature concerning the validity of LOC and overeating across the age and weight spectrum. Data sources English-language articles addressing the face, convergent, discriminant, and predictive validity of LOC and overeating were included. Results LOC and overeating appear to have adequate face validity. Emerging evidence supports the convergent and predictive validity of the LOC construct, given its unique cross-sectional and prospective associations with numerous anthropometric, psychosocial, and eating behavior-related factors. Overeating may be best conceptualized as a marker of excess weight status. Limitations Binge eating constructs, particularly in the context of subjectively large episodes, are challenging to measure reliably. Few studies addressed overeating in the absence of LOC, thereby limiting conclusions about the validity of the overeating construct independent of LOC. Additional studies addressing the discriminant validity of both constructs are warranted. Discussion Suggestions for future weight-related research and for appropriately defining binge eating in the eating disorders diagnostic scheme are presented. PMID:28165655

Development and Validation of a qRT-PCR Classifier for Lung Cancer Prognosis

PubMed Central

Chen, Guoan; Kim, Sinae; Taylor, Jeremy MG; Wang, Zhuwen; Lee, Oliver; Ramnath, Nithya; Reddy, Rishindra M; Lin, Jules; Chang, Andrew C; Orringer, Mark B; Beer, David G

2011-01-01

Purpose This prospective study aimed to develop a robust and clinically-applicable method to identify high-risk early stage lung cancer patients and then to validate this method for use in future translational studies. Patients and Methods Three published Affymetrix microarray data sets representing 680 primary tumors were used in the survival-related gene selection procedure using clustering, Cox model and random survival forest (RSF) analysis. A final set of 91 genes was selected and tested as a predictor of survival using a qRT-PCR-based assay utilizing an independent cohort of 101 lung adenocarcinomas. Results The RSF model built from 91 genes in the training set predicted patient survival in an independent cohort of 101 lung adenocarcinomas, with a prediction error rate of 26.6%. The mortality risk index (MRI) was significantly related to survival (Cox model p < 0.00001) and separated all patients into low, medium, and high-risk groups (HR = 1.00, 2.82, 4.42). The MRI was also related to survival in stage 1 patients (Cox model p = 0.001), separating patients into low, medium, and high-risk groups (HR = 1.00, 3.29, 3.77). Conclusions The development and validation of this robust qRT-PCR platform allows prediction of patient survival with early stage lung cancer. Utilization will now allow investigators to evaluate it prospectively by incorporation into new clinical trials with the goal of personalized treatment of lung cancer patients and improving patient survival. PMID:21792073

Hemorrhage Control for Major Traumatic Vascular Injuries

DTIC Science & Technology

2017-10-01

subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO...aims: 1) Determine current practice patterns for the treatment of patients with NCTH among 4 clinical sites using a retrospective study design (Phase...competency, and training issues for catheter-based hemorrhage control (Phase 1b); 3) Conduct a prospective 4-site observational study to test the hypothesis

Diurnal cortisol and mental well-being in middle and older age: evidence from four cohort studies

PubMed Central

Stafford, Mai; Ben-Shlomo, Yoav; Cooper, Cyrus; Gale, Catharine; Gardner, Michael P; Geoffroy, Marie-Claude; Power, Chris; Kuh, Diana; Cooper, Rachel

2017-01-01

Objectives We conducted an individual participant meta-analysis to test the hypothesis that cortisol patterns indicative of dysregulated hypothalamic–pituitary–adrenal axis functioning would be prospectively associated with poorer well-being at follow-up. Setting Four large UK-based cohort studies. Participants Those providing valid salivary or serum cortisol samples (n=7515 for morning cortisol; n=1612 for cortisol awakening response) at baseline (age 44–82) and well-being data on the Warwick Edinburgh Mental Wellbeing Scale at follow-up (0–8 years) were included. Results Well-being was not associated with morning cortisol, diurnal slope or awakening response though a borderline association with evening cortisol was found. Adjusting for sex and follow-up time, each 1 SD increase in evening cortisol was associated with a −0.47 (95% CI −1.00 to 0.05) point lower well-being. This was attenuated by adjustment for body mass index, smoking and socioeconomic position. Between-study heterogeneity was low. Conclusions This study does not support the hypothesis that diurnal cortisol is prospectively associated with well-being up to 8 years later. However, replication in prospective studies with cortisol samples over multiple days is required. PMID:29025828

Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

PubMed

Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

2017-02-01

Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

Validation of the Spanish Version of the Eating Assessment Tool-10 (EAT-10spa) in Colombia. A Blinded Prospective Cohort Study.

PubMed

Giraldo-Cadavid, Luis Fernando; Gutiérrez-Achury, Alejandra María; Ruales-Suárez, Karem; Rengifo-Varona, Maria Leonor; Barros, Camilo; Posada, Andrés; Romero, Carlos; Galvis, Ana María

2016-06-01

Dysphagia might affect 12 % of the general population, and its complications include pneumonia, malnutrition, social isolation, and death. No validated Spanish symptom survey exists to quantify dysphagia symptoms among Latin Americans. Therefore, we performed a prospective cohort study in a tertiary care university hospital to validate the Spanish version of the 10-Item Eating-Assessment-Tool (EAT-10spa) for use in Colombia. After an interdisciplinary committee of five bilingual specialists evaluated the EAT-10spa (translated and validated in Spain) and deemed it appropriate for the Colombian culture, its feasibility, reliability, validity, sensitivity to change, and diagnostic capacity were evaluated. As a reference standard, we used the flexible endoscopic evaluation of swallowing with sensory testing and a standardized clinical evaluation. All assessments were blinded. In total, 133 subjects were included (52 % women, mean age 55 years) and completed the EAT-10spa (median completion time: 2 min [IQR 1-3 min]), 39 % of whom had an elementary-level education. Cronbach's α coefficient: 0.91; test-retest intra-class correlation coefficient: 0.94. The Spearman's correlation coefficient of the EAT-10spa with the 8-point penetration-aspiration scale was 0.54 (P < 0.001). The area under the receiver-operating-characteristic-curve (AUC-ROC) for dysphagia and aspiration were 0.79 (P < 0.001) and 0.81 (P < 0.001), respectively. The best cut-off points for dysphagia and aspiration were EAT-10spa ≥2 (sensitivity 93.6 %, specificity 36.4 %) and EAT-10spa ≥4 (sensitivity 94.3 %, specificity 49.5 %), respectively. A reduction in the EAT-10 ≥3 was the best cut-off point for a clinically significant improvement (AUC-ROC 0.83; P < 0.0001). The EAT-10spa showed excellent psychometric properties and discriminatory capacity for use in Colombia.

Taking Forensics into the Community: Prospects for the Future.

ERIC Educational Resources Information Center

Garner, Patrick H.

As pressures within university communities continue to mount to provide validation of outcomes and maximize use of scarce financial resources, forensic teams can establish their own validity while helping communities in their time of need. As society begins to splinter and its problems fester, forensics can offer American communities the very…

Prospective pilots of routine data capture by paediatricians in clinics and validation of the Disabilities Complexity Scale.

PubMed

Horridge, Karen A; Mcgarry, Kenneth; Williams, Jane; Whitlingum, Gabriel

2016-06-01

To pilot prospective data collection by paediatricians at the point of care across England using a defined terminology set; demonstrate feasibility of data collection and utility of data outputs; and confirm that counting the number of needs per child is valid for quantifying complexity. Paediatricians in 16 hospital and community settings collected and anonymized data. Participants completed a survey regarding the process. Data were analysed using R version 3.1.2. Overall, 8117 needs captured from 1224 consultations were recorded. Sixteen clinicians responded positively about the process and utility of data collection. The sum of needs varied significantly (p<0.01) by level of gross motor function ascertained using the Gross Motor Function Classification System for children with cerebral palsy; epilepsy severity as defined by level of expertise required to manage it; and by severity of intellectual disability. Prospective data collection at the point of clinical care proved possible without disrupting clinics, even for those with the most complex needs, and took the least time when done electronically. Counting the number of needs was easy to do, and quantified complexity in a way that informed clinical care for individuals and related directly to validated scales of functioning. Data outputs could inform more appropriate design and commissioning of quality services. © 2016 Mac Keith Press.

Implementation and Effects of Risk-Dependent Obstetric Care in the Netherlands (Expect Study II): Protocol for an Impact Study.

PubMed

van Montfort, Pim; Willemse, Jessica Ppm; Dirksen, Carmen D; van Dooren, Ivo Ma; Meertens, Linda Je; Spaanderman, Marc Ea; Zelis, Maartje; Zwaan, Iris M; Scheepers, Hubertina Cj; Smits, Luc Jm

2018-05-04

Recently, validated risk models predicting adverse obstetric outcomes combined with risk-dependent care paths have been made available for early antenatal care in the southeastern part of the Netherlands. This study will evaluate implementation progress and impact of the new approach in obstetric care. The objective of this paper is to describe the design of a study evaluating the impact of implementing risk-dependent care. Validated first-trimester prediction models are embedded in daily clinical practice and combined with risk-dependent obstetric care paths. A multicenter prospective cohort study consisting of women who receive risk-dependent care is being performed from April 2017 to April 2018 (Expect Study II). Obstetric risk profiles will be calculated using a Web-based tool, the Expect prediction tool. The primary outcomes are the adherence of health care professionals and compliance of women. Secondary outcomes are patient satisfaction and cost-effectiveness. Outcome measures will be established using Web-based questionnaires. The secondary outcomes of the risk-dependent care cohort (Expect II) will be compared with the outcomes of a similar prospective cohort (Expect I). Women of this similar cohort received former care-as-usual and were prospectively included between July 1, 2013 and December 31, 2015 (Expect I). Currently, women are being recruited for the Expect Study II, and a total of 300 women are enrolled. This study will provide information about the implementation and impact of a new approach in obstetric care using prediction models and risk-dependent obstetric care paths. Netherlands Trial Register NTR4143; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4143 (Archived by WebCite at http://www.webcitation.org/6t8ijtpd9). ©Pim van Montfort, Jessica PPM Willemse, Carmen D Dirksen, Ivo MA van Dooren, Linda JE Meertens, Marc EA Spaanderman, Maartje Zelis, Iris M Zwaan, Hubertina CJ Scheepers, Luc JM Smits. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.05.2018.

Development and validation of a questionnaire to measure preferences and expectations of patients undergoing palliative chemotherapy: EXPECT questionnaire.

PubMed

Patil, V M; Chakraborty, S; Jithin, T K; Dessai, S; Sajith Babu, T P; Raghavan, V; Geetha, M; Kumar, T Shiva; Biji, M S; Bhattacharjee, A; Nair, C

2016-01-01

The objective was to design and validate the questionnaire for capturing palliative chemotherapy-related preferences and expectations. Single arm, unicentric, prospective observational study. EXPECT questionnaire was designed to capture preferences and expectations of patients undergoing palliative chemotherapy. This questionnaire underwent a linguistic validation and then was tested in patients. Ten patients are undergoing chemotherapy for solid tumors who fulfilled the inclusion and exclusion criteria self-administered the EXPECT questionnaire in regional language. After filling this questionnaire, they self-administered quick questionnaire-10 (QQ-10). SPSS version 16 (IBM New York) was used for analysis. Completion rate of EXPECT questionnaire was calculated. The feasibility, face validity, utility and time taken for completion of EXPECT questionnaire was also assessed. The completion rate of this questionnaire was 100%. All patients completed questionnaire within 5 min. The QQ-10 tool confirmed the feasibility, face validity and utility of the questionnaire. EXPECT questionnaire was validated in the regional language, and it's an effective tool for capturing patient's preferences and expectation from chemotherapy.

Nomogram to Predict Postoperative Readmission in Patients Who Undergo General Surgery.

PubMed

Tevis, Sarah E; Weber, Sharon M; Kent, K Craig; Kennedy, Gregory D

2015-06-01

The Centers for Medicare and Medicaid Services have implemented penalties for hospitals with above-average readmission rates under the Hospital Readmissions Reductions Program. These changes will likely be extended to affect postoperative readmissions in the future. To identify variables that place patients at risk for readmission, develop a predictive nomogram, and validate this nomogram. Retrospective review and prospective validation of a predictive nomogram. A predictive nomogram was developed with the linear predictor method using the American College of Surgeons National Surgical Quality Improvement Program database paired with institutional billing data for patients who underwent nonemergent inpatient general surgery procedures. The nomogram was developed from August 1, 2006, through December 31, 2011, in 2799 patients and prospectively validated from November 1, 2013, through December 19, 2013, in 255 patients at a single academic institution. Area under the curve and positive and negative predictive values were calculated. The outcome of interest was readmission within 30 days of discharge following an index hospitalization for a surgical procedure. Bleeding disorder (odds ratio, 2.549; 95% CI, 1.464-4.440), long operative time (odds ratio, 1.601; 95% CI, 1.186-2.160), in-hospital complications (odds ratio, 16.273; 95% CI, 12.028-22.016), dependent functional status, and the need for a higher level of care at discharge (odds ratio, 1.937; 95% CI, 1.176-3.190) were independently associated with readmission. The nomogram accurately predicted readmission (C statistic = 0.756) in a prospective evaluation. The negative predictive value was 97.9% in the prospective validation, while the positive predictive value was 11.1%. Development of an online calculator using this predictive model will allow us to identify patients who are at high risk for readmission at the time of discharge. Patients with increased risk may benefit from more intensive postoperative follow-up in the outpatient setting.

Development and Validation of a Risk Scale for Emergence Agitation After General Anesthesia in Children: A Prospective Observational Study.

PubMed

Hino, Maai; Mihara, Takahiro; Miyazaki, Saeko; Hijikata, Toshiyuki; Miwa, Takaaki; Goto, Takahisa; Ka, Koui

2017-08-01

Emergence agitation (EA) is a common complication in children after general anesthesia. The goal of this 2-phase study was (1) to develop a predictive model (EA risk scale) for the incidence of EA in children receiving sevoflurane anesthesia by performing a retrospective analysis of data from our previous study (phase 1) and (2) to determine the validity of the EA risk scale in a prospective observational cohort study (phase 2). Using data collected from 120 patients in our previous study, logistic regression analysis was used to predict the incidence of EA in phase 1. The optimal combination of the predictors was determined by a stepwise selection procedure using Akaike information criterion. The β-coefficient for the selected predictors was calculated, and scores for predictors determined. The predictive ability of the EA risk scale was assessed by a receiver operating characteristic (ROC) curve, and the area under the ROC curve (c-index) was calculated with a 95% confidence interval (CI). In phase 2, the validity of the EA risk scale was confirmed using another data set of 100 patients (who underwent minor surgery under general anesthesia). The ROC curve, the c-index, the best cutoff point, and the sensitivity and specificity at the point were calculated. In addition, we calculated the gray zone, which ranges between the two points where sensitivity and specificity, respectively, become 90%. In phase 1, the final model of the multivariable logistic regression analysis included the following 4 predictors: age (logarithm odds ratios [OR], -0.38; 95% CI, -0.81 to 0.00), Pediatric Anesthesia Behavior score (logarithm OR, 0.65; 95% CI, -0.09 to 1.40), anesthesia time (logarithm OR, 0.60; 95% CI, -0.18 to 1.19), and operative procedure (logarithm OR, 2.53; 95% CI, 1.30-3.75 for strabismus surgery and logarithm OR, 2.71; 95% CI, 0.99-4.45 for tonsillectomy). The EA risk scale included these 4 predictors and ranged from 1 to 23 points. In phase 2, the incidence of EA was 39%. The c-index of phase 1 was 0.84 (95% CI, 0.74-0.94), and the c-index of phase 2 was 0.81 (95% CI, 0.72-0.89). The best cutoff point for the EA risk scale was 11 (sensitivity = 87% and specificity = 61%). The gray zone ranged from 10 to 13 points, and included 38% of patients. We developed and validated an EA risk scale for children receiving sevoflurane anesthesia. In our validation cohort, this scale has excellent predictive performance (c-index > 0.8). The EA risk scale could be used to predict EA in children and adopt a preventive strategy for those at high risk. This score-based preventive approach should be studied prospectively to assess the safety and efficacy of such a strategy.

Bleeding impacting mortality after noncardiac surgery: a protocol to establish diagnostic criteria, estimate prognostic importance, and develop and validate a prediction guide in an international prospective cohort study

PubMed Central

Roshanov, Pavel S.; Eikelboom, John W.; Crowther, Mark; Tandon, Vikas; Borges, Flavia K.; Kearon, Clive; Lamy, Andre; Whitlock, Richard; Biccard, Bruce M.; Szczeklik, Wojciech; Guyatt, Gordon H.; Panju, Mohamed; Spence, Jessica; Garg, Amit X.; McGillion, Michael; VanHelder, Tomas; Kavsak, Peter A.; de Beer, Justin; Winemaker, Mitchell; Sessler, Daniel I.; Le Manach, Yannick; Sheth, Tej; Pinthus, Jehonathan H.; Thabane, Lehana; Simunovic, Marko R.I.; Mizera, Ryszard; Ribas, Sebastian; Devereaux, P.J.

2017-01-01

Introduction: Various definitions of bleeding have been used in perioperative studies without systematic assessment of the diagnostic criteria for their independent association with outcomes important to patients. Our proposed definition of bleeding impacting mortality after noncardiac surgery (BIMS) is bleeding that is independently associated with death during or within 30 days after noncardiac surgery. We describe our analysis plan to sequentially 1) establish the diagnostic criteria for BIMS, 2) estimate the independent contribution of BIMS to 30-day mortality and 3) develop and internally validate a clinical prediction guide to estimate patient-specific risk of BIMS. Methods: In the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) study, we prospectively collected bleeding data for 16 079 patients aged 45 years or more who had noncardiac inpatient surgery between 2007 and 2011 at 12 centres in 8 countries across 5 continents. We will include bleeding features independently associated with 30-day mortality in the diagnostic criteria for BIMS. Candidate features will include the need for reoperation due to bleeding, the number of units of erythrocytes transfused, the lowest postoperative hemoglobin concentration, and the absolute and relative decrements in hemoglobin concentration from the preoperative value. We will then estimate the incidence of BIMS and its independent association with 30-day mortality. Last, we will construct and internally validate a clinical prediction guide for BIMS. Interpretation: This study will address an important gap in our knowledge about perioperative bleeding, with implications for the 200 million patients who undergo noncardiac surgery globally every year. Trial registration: ClinicalTrials.gov, no NCT00512109. PMID:28943515

Validation of a Korean MMPI-2 Hwa-Byung scale using a Korean normative sample.

PubMed

Ketterer, Holly; Han, Kyunghee; Weed, Nathan C

2010-07-01

The psychometric properties of a recently developed measure of Hwa-Byung (HB), a Korean culture bound syndrome, using an updated version of the Korean Minnesota Multiphasic Personality Inventory-2, were examined in Korean normative sample. Confirmatory factor analyses indicated that both the first-order four-factor model and the single second-order factor model fit the data well, but the latter may be superior because of its parsimony. The HB scale correlated modestly with age, sex, SES, and problems with family and finance. However, it showed substantial correlations with spouse ratings items that were identified a priori as prospective HB correlates, indicating excellent concurrent validity. The limitations of the study and the need for future studies employing HB patients were discussed.

The predictive validity of prospect theory versus expected utility in health utility measurement.

PubMed

Abellan-Perpiñan, Jose Maria; Bleichrodt, Han; Pinto-Prades, Jose Luis

2009-12-01

Most health care evaluations today still assume expected utility even though the descriptive deficiencies of expected utility are well known. Prospect theory is the dominant descriptive alternative for expected utility. This paper tests whether prospect theory leads to better health evaluations than expected utility. The approach is purely descriptive: we explore how simple measurements together with prospect theory and expected utility predict choices and rankings between more complex stimuli. For decisions involving risk prospect theory is significantly more consistent with rankings and choices than expected utility. This conclusion no longer holds when we use prospect theory utilities and expected utilities to predict intertemporal decisions. The latter finding cautions against the common assumption in health economics that health state utilities are transferable across decision contexts. Our results suggest that the standard gamble and algorithms based on, should not be used to value health.

Multimodal Navigation in Endoscopic Transsphenoidal Resection of Pituitary Tumors using Image-based Vascular and Cranial Nerve Segmentation: A Prospective Validation Study

PubMed Central

Dolati, Parviz; Eichberg, Daniel; Golby, Alexandra; Zamani, Amir; Laws, Edward

2016-01-01

Introduction Transsphenoidal surgery (TSS) is a well-known approach for the treatment of pituitary tumors. However, lateral misdirection and vascular damage, intraoperative CSF leakage, and optic nerve and vascular injuries are all well-known complications, and the risk of adverse events is more likely in less experienced hands. This prospective study was conducted to validate the accuracy of image-based segmentation in localization of neurovascular structures during TSS. Methods Twenty-five patients with pituitary tumors underwent preoperative 3TMRI, which included thin-sectioned 3D space T2, 3D Time of Flight and MPRAGE sequences. Images were reviewed by an expert independent neuroradiologist. Imaging sequences were loaded in BrainLab iPlanNet (16/25 cases) or Stryker (9/25 cases) image guidance platforms for segmentation and pre-operative planning. After patient registration into the neuronavigation system and subsequent surgical exposure, each segmented neural or vascular element was validated by manual placement of the navigation probe on or as close as possible to the target. The audible pulsations of the bilateral ICA were confirmed using a micro-Doppler probe. Results Pre-operative segmentation of the ICA and cavernous sinus matched with the intra-operative endoscopic and micro-Doppler findings in all cases (Dice Similarity Coefficient =1). This information reassured the surgeons with regard to the lateral extent of bone removal at the sellar floor and the limits of lateral exploration. Excellent correspondence between image-based segmentation and the endoscopic view was also evident at the surface of the tumor and at the tumor-normal gland interfaces. This assisted in preventing unnecessary removal of the normal pituitary gland. Image-guidance assisted the surgeons in localizing the optic nerve and chiasm in 64% of the cases and the diaphragma sella in 52% of cases, which helped to determine the limits of upward exploration and to decrease the risk of CSF leakage. The accuracy of the measurements was 1.20 + 0.21 mm (mean +/−SD). Conclusion Image-based pre-operative vascular and neural element segmentation, especially with 3D reconstruction, is highly informative preoperatively and potentially could assist less experienced neurosurgeons in preventing vascular and neural injury during TSS. Additionally, the accuracy found in this study is comparable to previously reported neuronavigation measurements. This novel preliminary study is encouraging for future prospective intraoperative validation with larger numbers of patients. PMID:27302558

Braden scale (ALB) for assessing pressure ulcer risk in hospital patients: A validity and reliability study.

PubMed

Chen, Hong-Lin; Cao, Ying-Juan; Zhang, Wei; Wang, Jing; Huai, Bao-Sha

2017-02-01

The inter-rater reliability of Braden Scale is not so good. We modified the Braden(ALB) scale by defining nutrition subscale based on serum albumin, then assessed it's the validity and reliability in hospital patients. We designed a retrospective study for validity analysis, and a prospective study for reliability analysis. Receiver operating curve (ROC) and area under the curve (AUC) were used to evaluate the predictive validity. Intra-class correlation coefficient (ICC) was used to investigate the inter-rater reliability. Two thousand five hundred twenty-five patients were included for validity analysis, 76 patients (3.0%) developed pressure ulcer. Positive correlation was found between serum albumin and nutrition score in Braden scale (Spearman's coefficient 0.2203, P<0.0001). The AUCs for Braden scale and Braden(ALB) scale predicting pressure ulcer risk were 0.813 (95% CI 0.797-0.828; P<0.0001), and 0.859 (95% CI 0.845-0.872; P<0.0001), respectively. The Braden(ALB) scale was even more valid than the Braden scale (z=1.860, P=0.0628). In different age subgroups, the Braden(ALB) scale seems also more valid than the original Braden scale, but no statistically significant differences were found (P>0.05). The inter-rater reliability study showed the ICC-value for nutrition increased 45.9%, and increased 4.3% for total score. The Braden(ALB) scale has similar validity compared with the original Braden scale for in hospital patients. However, the inter-rater reliability was significantly increased. Copyright © 2016 Elsevier Inc. All rights reserved.

Anxiety sensitivity as a predictor of panic disorder symptoms: a prospective 3-year study.

PubMed

Jurin, Tanja; Biglbauer, Sonja

2018-07-01

Anxiety sensitivity (AS) is the fear of anxiety symptoms, a feature proven to be an important vulnerability factor for anxiety pathogenesis. The aim of this study was to examine whether AS (as well as its factors) predicts the onset of panic disorder symptoms when controlling for the contribution of trait anxiety. We conducted a prospective 3 year follow up study. The participants, students at the Humanities and Social Sciences in Zagreb (N = 1087), completed an Anxiety Sensitivity Index and State-Trait Anxiety Inventory (Trait form) and, after a period of three years, were asked to self-assess criteria for panic disorder (according to the DSM-5). The predictive validity of AS for the onset of panic disorder symptoms, regardless of trait anxiety, was confirmed. Furthermore, the physical concerns dimension of AS was the only significant predictor of panic disorder symptoms. The optimal cutoff score of 25 on the ASI provides poor to moderate accuracy indices in detecting participants who will manifest panic disorder symptoms in the next three years. This study contributes to our current understanding of AS as a prospective risk factor for panic disorder symptoms.

From integrated observation of pre-earthquake signals towards physical-based forecasting: A prospective test experiment

NASA Astrophysics Data System (ADS)

Ouzounov, D.; Pulinets, S. A.; Tramutoli, V.; Lee, L.; Liu, J. G.; Hattori, K.; Kafatos, M.

2013-12-01

We are conducting an integrated study involving multi-parameter observations over different seismo- tectonics regions in our investigation of phenomena preceding major earthquakes. Our approach is based on a systematic analysis of several selected parameters namely: gas discharge; thermal infrared radiation; ionospheric electron concentration; and atmospheric temperature and humidity, which we suppose are associated with earthquake preparation phase. We intended to test in prospective mode the set of geophysical measurements for different regions of active earthquakes and volcanoes. In 2012-13 we established a collaborative framework with the leading projects PRE-EARTHQUAKE (EU) and iSTEP3 (Taiwan) for coordinate measurements and prospective validation over seven test regions: Southern California (USA), Eastern Honshu (Japan), Italy, Turkey, Greece, Taiwan (ROC), Kamchatka and Sakhalin (Russia). The current experiment provided a 'stress test' opportunity to validate the physical based approach in teal -time over regions of high seismicity. Our initial results are: (1) Prospective tests have shown the presence in real time of anomalies in the atmosphere before most of the significant (M>5.5) earthquakes in all regions; (2) False positive rate alarm is different for each region and varying between 50% (Italy, Kamchatka and California) to 25% (Taiwan and Japan) with a significant reduction of false positives when at least two parameters are contemporary used; (3) One of most complex problem, which is still open, was the systematic collection and real-time integration of pre-earthquake observations. Our findings suggest that the physical based short-term forecast is feasible and more tests are needed. We discus the physical concept we used, the future integration of data observations and related developments.

Delineation of ground water potential zones using GIS and remote sensing - A case study from midland region of Vamanapuram river basin, Kerala, India

NASA Astrophysics Data System (ADS)

Prasad, Geena; Vinod P., G.; John, Shaleena Elizabeth

2018-04-01

In a highly rugged terrain, shielded by hard crystalline rocks like that of Kerala, locating potential zones of groundwater is found to be an unenviable task. Remote sensing and Geographical information system technologies have been attempted widely to delineate the potential regions in such terrain. Geographical information system tool has been used for delineation of groundwater prospect zones in midland physiographic zone (30-200m) of Vamanapuram river basin. The terrain variables are generated using satellite imageries, SRTM DEM data of 30m resolution and SOI toposheets. The groundwater prospect zones were delineated through the integration of the reclassified raster map layers of geomorphology, slope percent, geology, land use / land cover and soil texture using the weighted overlay analysis in the GIS platform. The groundwater prospects in the study area were grouped into five classes and their distribution are; `very high/high' (8.79%), `moderate' (39.08%), and `very low / low' (52.01%). The study result of the area has been validated with water level data of dug wells and bore wells of the area. The spatial distribution map of the water level of the region is overlaid on groundwater prospect map and shows a positive correlation i.e., the water level at shallow depth in higher prospect zones and at deeper depth in poor to very poor zones. The Groundwater prospect map of midland region of Vamanapuram river basin can be used as base level information which can be further investigated with geophysical methods to locate potential well sites for the execution of water supply schemes.

Emergency Severity Index version 4: a valid and reliable tool in pediatric emergency department triage.

PubMed

Green, Nicole A; Durani, Yamini; Brecher, Deena; DePiero, Andrew; Loiselle, John; Attia, Magdy

2012-08-01

The Emergency Severity Index version 4 (ESI v.4) is the most recently implemented 5-level triage system. The validity and reliability of this triage tool in the pediatric population have not been extensively established. The goals of this study were to assess the validity of ESI v.4 in predicting hospital admission, emergency department (ED) length of stay (LOS), and number of resources utilized, as well as its reliability in a prospective cohort of pediatric patients. The first arm of the study was a retrospective chart review of 780 pediatric patients presenting to a pediatric ED to determine the validity of ESI v.4. Abstracted data included acuity level assigned by the triage nurse using ESI v.4 algorithm, disposition (admission vs discharge), LOS, and number of resources utilized in the ED. To analyze the validity of ESI v.4, patients were divided into 2 groups for comparison: higher-acuity patients (ESI levels 1, 2, and 3) and lower-acuity patients (ESI levels 4 and 5). Pearson χ analysis was performed for categorical variables. For continuous variables, we conducted a comparison of means based on parametric distribution of variables. The second arm was a prospective cohort study to determine the interrater reliability of ESI v.4 among and between pediatric triage (PT) nurses and pediatric emergency medicine (PEM) physicians. Three raters (2 PT nurses and 1 PEM physician) independently assigned triage scores to 100 patients; k and interclass correlation coefficient were calculated among PT nurses and between the primary PT nurses and physicians. In the validity arm, the distribution of ESI score levels among the 780 cases are as follows: ESI 1: 2 (0.25%); ESI 2: 73 (9.4%); ESI 3: 289 (37%); ESI 4: 251 (32%); and ESI 5: 165 (21%). Hospital admission rates by ESI level were 1: 100%, 2: 42%, 3: 14.9%, 4: 1.2%, and 5: 0.6%. The admission rate of the higher-acuity group (76/364, 21%) was significantly greater than the lower-acuity group (4/415, 0.96%), P < 0.001. The mean ED LOS (in minutes) for the higher-acuity group was 257 (SD, 132) versus 143 (SD, 81) in the lower-acuity group, P < 0.001. The higher-acuity group also had significantly greater use of resources than the lower-acuity group, P < 0.001. The percentage of low-acuity patients receiving no resources was 54%, compared with only 26% in the higher-acuity group. Conversely, a greater percentage of higher-acuity patients utilized 2 or more resources than the lower-acuity cohorts, 43% vs 12%, respectively, P < 0.001. In the prospective reliability arm of the study, 15 PT nurses and 8 PEM attending physicians participated in the study; k among nurses was 0.92 and between the primary triage nurses and physicians was 0.78, P < 0.001. The intraclass correlation coefficient was 0.96 for PT nurses and 0.91 between the primary triage nurse and physicians, P < 0.001. Emergency Severity Index v.4 is a valid predictor of hospital admission, ED LOS, and resource utilization in the pediatric ED population. It is a reliable pediatric triage instrument with high agreement among PT nurses and between PT nurses and PEM physicians.

Changing Behavior by Memory Aids: A Social Psychological Model of Prospective Memory and Habit Development Tested with Dynamic Field Data

ERIC Educational Resources Information Center

Tobias, Robert

2009-01-01

This article presents a social psychological model of prospective memory and habit development. The model is based on relevant research literature, and its dynamics were investigated by computer simulations. Time-series data from a behavior-change campaign in Cuba were used for calibration and validation of the model. The model scored well in…

Design and validation of pictograms in a pediatric anaphylaxis action plan.

PubMed

Mok, Garrick; Vaillancourt, Régis; Irwin, Danica; Wong, Alexandre; Zemek, Roger; Alqurashi, Waleed

2015-05-01

Current anaphylaxis action plans (AAPs) are based on written instructions without inclusion of pictograms. To develop an AAP with pictorial aids and to prospectively validate the pictogram components of this plan. Participants recruited from the emergency department and allergy clinic participated in a questionnaire to validate pictograms depicting key counseling points of an anaphylactic reaction. Children ≥ 10 years of age and caregivers of children < 10 years with acute anaphylaxis or who carried epinephrine auto-injector for confirmed allergy were eligible. Guessability, translucency, and recall were assessed for 11 pictogram designs. Pictograms identified as correct or partially correct by at least 85% of participants were considered valid. Three independent reviewers assessed these outcome measures. Of the 115 total participants, 73 (63%) were female, 76 (66%) were parents/guardians, and 39 (34%) were children aged 10-17. Overall, 10 pictograms (91%) reached ≥ 85% for correct guessability, translucency, and recall. Four pictograms were redesigned to reach the preset validation target. One pictogram depicting symptom management (5-min wait time after first epinephrine treatment) reached 82% translucency after redesign. However, it reached 98% and 100% of correct guessability and recall, respectively. We prospectively designed and validated a set of pictograms to be included in an AAP. The incorporation of validated pictograms into an AAP may potentially increase comprehension of the triggers, signs and symptoms, and management of an anaphylactic reaction. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Combined Use of Tissue Morphology, Neural Network Analysis of Chromatin Texture and Clinical Variables to Predict Prostate Cancer Agressiveness from Biopsy Water

DTIC Science & Technology

2000-10-01

Purpose: To combine clinical, serum, pathologic and computer derived information into an artificial neural network to develop/validate a model to...Development of an artificial neural network (year 02). Prospective validation of this model (projected year 03). All models will be tested and

15 CFR Supplement No. 8 to Part 748 - Information Required in Requests for Validated End-User (Veu) Authorization

Code of Federal Regulations, 2010 CFR

2010-01-01

... overview of any business activity or corporate relationship that the entity has with either government or... structure, ownership and business of the prospective validated end-user. Include a description of the entity...-site reviews by U.S. Government officials to verify the end-user's compliance with the conditions of...

An Independent, Prospective, Head to Head Study of the Reliability and Validity of Neurocognitive Test Batteries for the Assessment of Mild Traumatic Brain Injury

DTIC Science & Technology

2013-03-01

hockey, field hockey, rugby, wrestling), football will provide the large quantity of both baseline testing participants and concussed athletes. 6...baselines (7.0% overall) • Injury protocol completed on 10 concussed athletes and 10 matched controls in fall sports season (excluding football 2012...Neurobehavioral Assessment (DANA), and Immediate Post- Concussion Assessment and Cognitive Testing (ImPACT). The study design involves both a Sports

Chemotherapy-Induced Cognitive Impairment: A Novel Prospective Study of the Cognitive Effects of Platinum Taxane-Based Chemotherapy in Ovarian Cancer Patients

DTIC Science & Technology

2016-09-01

hope to generate new data on neurocognitive testing for CICI in gynecologic cancers, provide validation for counseling gynecologic oncology patients...cytoreductive surgery and adjuvant therapy are not included in this group .” Patients undergoing neoadjuvant chemotherapy will now be included in this group , as...representative group of patients to undergoing treatment for ovarian cancer and enhance accrual for this study. 4. Deleted exclusion criterion (previously

Defining when to initiate massive transfusion: a validation study of individual massive transfusion triggers in PROMMTT patients.

PubMed

Callcut, Rachael A; Cotton, Bryan A; Muskat, Peter; Fox, Erin E; Wade, Charles E; Holcomb, John B; Schreiber, Martin A; Rahbar, Mohammad H; Cohen, Mitchell J; Knudson, M Margaret; Brasel, Karen J; Bulger, Eileen M; Del Junco, Deborah J; Myers, John G; Alarcon, Louis H; Robinson, Bryce R H

2013-01-01

Early predictors of massive transfusion (MT) would prevent undertriage of patients likely to require MT. This study validates triggers using the Prospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study. All enrolled patients in PROMMTT were analyzed. The initial emergency department value for each trigger (international normalized ratio [INR], systolic blood pressure, hemoglobin, base deficit, positive result for Focused Assessment for the Sonography of Trauma examination, heart rate, temperature, and penetrating injury mechanism) was compared for patients receiving MT (≥ 10 U of packed red blood cells in 24 hours) versus no MT. Adjusted odds ratios (ORs) for MT are reported using multiple logistic regression. If all triggers were known, a Massive Transfusion Score (MTS) was created, with 1 point assigned for each met trigger. A total of 1,245 patients were prospectively enrolled with 297 receiving an MT. Data were available for all triggers in 66% of the patients including 67% of the MTs (199 of 297). INR was known in 87% (1,081 of 1,245). All triggers except penetrating injury mechanism and heart rate were valid individual predictors of MT, with INR as the most predictive (adjusted OR, 2.5; 95% confidence interval, 1.7-3.7). For those with all triggers known, a positive INR trigger was seen in 49% receiving MT. Patients with an MTS of less than 2 were unlikely to receive MT (negative predictive value, 89%). If any two triggers were present (MTS ≥ 2), sensitivity for predicting MT was 85%. MT was present in 33% with an MTS of 2 greater compared with 11% of those with MTS of less than 2 (OR, 3.9; 95% confidence interval, 2.6-5.8; p < 0.0005). Parameters that can be obtained early in the initial emergency department evaluation are valid predictors for determining the likelihood of MT. Diagnostic, level II.

Prediction of serious complications in patients with seemingly stable febrile neutropenia: validation of the Clinical Index of Stable Febrile Neutropenia in a prospective cohort of patients from the FINITE study.

PubMed

Carmona-Bayonas, Alberto; Jiménez-Fonseca, Paula; Virizuela Echaburu, Juan; Antonio, Maite; Font, Carme; Biosca, Mercè; Ramchandani, Avinash; Martínez, Jerónimo; Hernando Cubero, Jorge; Espinosa, Javier; Martínez de Castro, Eva; Ghanem, Ismael; Beato, Carmen; Blasco, Ana; Garrido, Marcelo; Bonilla, Yaiza; Mondéjar, Rebeca; Arcusa Lanza, María Ángeles; Aragón Manrique, Isabel; Manzano, Aránzazu; Sevillano, Elena; Castañón, Eduardo; Cardona, Mercé; Gallardo Martín, Elena; Pérez Armillas, Quionia; Sánchez Lasheras, Fernando; Ayala de la Peña, Francisco

2015-02-10

To validate a prognostic score predicting major complications in patients with solid tumors and seemingly stable episodes of febrile neutropenia (FN). The definition of clinical stability implies the absence of organ dysfunction, abnormalities in vital signs, and major infections. We developed the Clinical Index of Stable Febrile Neutropenia (CISNE), with six explanatory variables associated with serious complications: Eastern Cooperative Oncology Group performance status ≥ 2 (2 points), chronic obstructive pulmonary disease (1 point), chronic cardiovascular disease (1 point), mucositis of grade ≥ 2 (National Cancer Institute Common Toxicity Criteria; 1 point), monocytes < 200 per μL (1 point), and stress-induced hyperglycemia (2 points). We integrated these factors into a score ranging from 0 to 8, which classifies patients into three prognostic classes: low (0 points), intermediate (1 to 2 points), and high risk (≥ 3 points). We present a multicenter validation of CISNE. We prospectively recruited 1,133 patients with seemingly stable FN from 25 hospitals. Complication rates in the training and validation subsets, respectively, were 1.1% and 1.1% in low-, 6.1% and 6.2% in intermediate-, and 32.5% and 36% in high-risk patients; mortality rates within each class were 0% in low-, 1.6% and 0% in intermediate-, and 4.3% and 3.1% in high-risk patients. Areas under the receiver operating characteristic curves in the validation subset were 0.652 (95% CI, 0.598 to 0.703) for Talcott, 0.721 (95% CI, 0.669 to 0.768) for Multinational Association for Supportive Care in Cancer (MASCC), and 0.868 (95% CI, 0.827 to 0.903) for CISNE (P = .002 for comparison between CISNE and MASCC). CISNE is a valid model for accurately classifying patients with cancer with seemingly stable FN episodes. © 2015 by American Society of Clinical Oncology.

Compensatory enlargement of the left main coronary artery: insights from the PROSPECT study.

PubMed

Inaba, Shinji; Mintz, Gary S; Shimizu, Takehisa; Weisz, Giora; Mehran, Roxana; Marso, Steven P; Xu, Ke; de Bruyne, Bernard; Serruys, Patrick W; Stone, Gregg W; Maehara, Akiko

2014-03-01

Glagov proposed that remodeling delayed development of significant coronary artery stenoses until plaque occupied, on average, 40% of arterial area (40% plaque burden). The aim of the current study was to confirm the previously proposed concept of coronary remodeling as first described by Glagov who studied postmortem left main coronary arteries (LMCAs). Using the in-vivo intravascular ultrasound data from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study, we evaluated 552 LMCAs in 552 patients. External elastic membrane cross-sectional areas (CSAs) increased in proportion to the increase in plaque and media CSAs (r=0.61, P<0.0001), especially when the plaque burden was 20% or lower (r=0.88, P<0.0001). For more advanced atherosclerosis (>40% plaque burden), there was an inverse relationship between lumen CSA and plaque burden (r=-0.57, P<0.0001), whereas this relationship was weak in the presence of less than 40% plaque burden. The frequency of virtual histology derived thin-cap fibroatheroma increased with increasing plaque burden. In contrast, the frequency of pathological intimal thickening decreased. The previously proposed remodeling concept of Glagov was validated in vivo in the PROSPECT study patients. In addition, the present study suggested that plaque phenotype worsened with increasing LMCA plaque growth.

Dynamic TIMI Risk Score for STEMI

PubMed Central

Amin, Sameer T.; Morrow, David A.; Braunwald, Eugene; Sloan, Sarah; Contant, Charles; Murphy, Sabina; Antman, Elliott M.

2013-01-01

Background Although there are multiple methods of risk stratification for ST‐elevation myocardial infarction (STEMI), this study presents a prospectively validated method for reclassification of patients based on in‐hospital events. A dynamic risk score provides an initial risk stratification and reassessment at discharge. Methods and Results The dynamic TIMI risk score for STEMI was derived in ExTRACT‐TIMI 25 and validated in TRITON‐TIMI 38. Baseline variables were from the original TIMI risk score for STEMI. New variables were major clinical events occurring during the index hospitalization. Each variable was tested individually in a univariate Cox proportional hazards regression. Variables with P<0.05 were incorporated into a full multivariable Cox model to assess the risk of death at 1 year. Each variable was assigned an integer value based on the odds ratio, and the final score was the sum of these values. The dynamic score included the development of in‐hospital MI, arrhythmia, major bleed, stroke, congestive heart failure, recurrent ischemia, and renal failure. The C‐statistic produced by the dynamic score in the derivation database was 0.76, with a net reclassification improvement (NRI) of 0.33 (P<0.0001) from the inclusion of dynamic events to the original TIMI risk score. In the validation database, the C‐statistic was 0.81, with a NRI of 0.35 (P=0.01). Conclusions This score is a prospectively derived, validated means of estimating 1‐year mortality of STEMI at hospital discharge and can serve as a clinically useful tool. By incorporating events during the index hospitalization, it can better define risk and help to guide treatment decisions. PMID:23525425

Dynamic TIMI risk score for STEMI.

PubMed

Amin, Sameer T; Morrow, David A; Braunwald, Eugene; Sloan, Sarah; Contant, Charles; Murphy, Sabina; Antman, Elliott M

2013-01-29

Although there are multiple methods of risk stratification for ST-elevation myocardial infarction (STEMI), this study presents a prospectively validated method for reclassification of patients based on in-hospital events. A dynamic risk score provides an initial risk stratification and reassessment at discharge. The dynamic TIMI risk score for STEMI was derived in ExTRACT-TIMI 25 and validated in TRITON-TIMI 38. Baseline variables were from the original TIMI risk score for STEMI. New variables were major clinical events occurring during the index hospitalization. Each variable was tested individually in a univariate Cox proportional hazards regression. Variables with P<0.05 were incorporated into a full multivariable Cox model to assess the risk of death at 1 year. Each variable was assigned an integer value based on the odds ratio, and the final score was the sum of these values. The dynamic score included the development of in-hospital MI, arrhythmia, major bleed, stroke, congestive heart failure, recurrent ischemia, and renal failure. The C-statistic produced by the dynamic score in the derivation database was 0.76, with a net reclassification improvement (NRI) of 0.33 (P<0.0001) from the inclusion of dynamic events to the original TIMI risk score. In the validation database, the C-statistic was 0.81, with a NRI of 0.35 (P=0.01). This score is a prospectively derived, validated means of estimating 1-year mortality of STEMI at hospital discharge and can serve as a clinically useful tool. By incorporating events during the index hospitalization, it can better define risk and help to guide treatment decisions.

Ambulance smartphone tool for field triage of ruptured aortic aneurysms (FILTR): study protocol for a prospective observational validation of diagnostic accuracy.

PubMed

Lewis, Thomas L; Fothergill, Rachael T; Karthikesalingam, Alan

2016-10-24

Rupture of an abdominal aortic aneurysm (rAAA) carries a considerable mortality rate and is often fatal. rAAA can be treated through open or endovascular surgical intervention and it is possible that more rapid access to definitive intervention might be a key aspect of improving mortality for rAAA. Diagnosis is not always straightforward with up to 42% of rAAA initially misdiagnosed, introducing potentially harmful delay. There is a need for an effective clinical decision support tool for accurate prehospital diagnosis and triage to enable transfer to an appropriate centre. Prospective multicentre observational study assessing the diagnostic accuracy of a prehospital smartphone triage tool for detection of rAAA. The study will be conducted across London in conjunction with London Ambulance Service (LAS). A logistic score predicting the risk of rAAA by assessing ten key parameters was developed and retrospectively validated through logistic regression analysis of ambulance records and Hospital Episode Statistics data for 2200 patients from 2005 to 2010. The triage tool is integrated into a secure mobile app for major smartphone platforms. Key parameters collected from the app will be retrospectively matched with final hospital discharge diagnosis for each patient encounter. The primary outcome is to assess the sensitivity, specificity and positive predictive value of the rAAA triage tool logistic score in prospective use as a mob app for prehospital ambulance clinicians. Data collection started in November 2014 and the study will recruit a minimum of 1150 non-consecutive patients over a time period of 2 years. Full ethical approval has been gained for this study. The results of this study will be disseminated in peer-reviewed publications, and international/national presentations. CPMS 16459; pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Validation of the Penn Acoustic Neuroma Quality-of-Life Scale (PANQOL) for Spanish-Speaking Patients.

PubMed

Medina, Maria Del Mar; Carrillo, Alvaro; Polo, Ruben; Fernandez, Borja; Alonso, Daniel; Vaca, Miguel; Cordero, Adela; Perez, Cecilia; Muriel, Alfonso; Cobeta, Ignacio

2017-04-01

Objective To perform translation, cross-cultural adaptation, and validation of the Penn Acoustic Neuroma Quality-of-Life Scale (PANQOL) to the Spanish language. Study Design Prospective study. Setting Tertiary neurotologic referral center. Subjects and Methods PANQOL was translated and translated back, and a pretest trial was performed. The study included 27 individuals diagnosed with vestibular schwannoma. Inclusion criteria were adults with untreated vestibular schwannoma, diagnosed in the past 12 months. Feasibility, internal consistency, test-retest reliability, construct validity, and ceiling and floor effects were assessed for the present study. Results The mean overall score of the PANQOL was 69.21 (0-100 scale, lowest to highest quality of life). Cronbach's α was 0.87. Intraclass correlation coefficient was performed for each item, with an overall score of 0.92. The κ coefficient scores were between moderate and almost perfect in more than 92% of patients. Anxiety and energy domains of the PANQOL were correlated with both physical and mental components of the SF-12. Hearing, balance, and pain domains were correlated with the SF-12 physical component. Facial and general domains were not significantly correlated with any component of the SF-12. Furthermore, the overall score of the PANQOL was correlated with the physical component of the SF-12. Conclusion Feasibility, internal consistency, reliability, and construct validity outcomes in the current study support the validity of the Spanish version of the PANQOL.

The multi-dimensional measure of informed choice: a validation study.

PubMed

Michie, Susan; Dormandy, Elizabeth; Marteau, Theresa M

2002-09-01

The aim of this prospective study is to assess the reliability and validity of a multi-dimensional measure of informed choice (MMIC). Participants were 225 pregnant women in two general hospitals in the UK, women receiving low-risk results following serum screening for Down syndrome. The MMIC was administered before testing and the Ottawa Decisional Conflict Scale was administered 6 weeks later. The component scales of the MMIC, knowledge and attitude, were internally consistent (alpha values of 0.68 and 0.78, respectively). Those who made a choice categorised as informed using the MMIC rated their decision 6 weeks later as being more informed, better supported and of higher quality than women whose choice was categorised as uninformed. This provides evidence of predictive validity, whilst the lack of association between the MMIC and anxiety shows construct (discriminant) validity. Thus, the MMIC has been shown to be psychometrically robust in pregnant women offered the choice to undergo prenatal screening for Down syndrome and receiving a low-risk result. Replication of this finding in other groups, facing other decisions, with other outcomes, should be assessed in future research.

Valid screening questions useful to diagnose hand and forearm eczema are available in the Spanish language, a new tool for global research.

PubMed

Martí-Margarit, Anna; Manresa, Josep M; Herdman, Mike; Pujol, Ramon; Serra, Consol; Flyvholm, Mary-Ann; Giménez-Arnau, Ana M

2015-04-01

Hand eczema is an impacting cutaneous disease. Globally valid tools that help to diagnose hand and forearm eczema are required. To validate the questions to detect hand and/or forearm eczema included in the "Nordic Occupational Skin Questionnaire" (NOSQ-2002) in the Spanish language. A prospective pilot study was conducted with 80 employees of a cleaning company and a retrospective one involving 2,546 individuals. The responses were analysed for sensitivity, specificity and positive and negative predictive values. The final diagnosis according to the patients' hospital records, the specialty care records and the physical examination was taken as gold standard. The Dermatology Life Quality Index (DLQI) was also evaluated. Sensitivity and specificity, in a worst case scenario (WC) combining both questions, were 96.5% and 66.7%, respectively, and in a per protocol (PP) analysis, were 96.5% and 75.2%. The questions validated detected eczema effectively, making this tool suitable for use e.g. in multicentre epidemiological studies or clinical trials.

EDRN Breast and Ovary Cancer CVC, Study 4: Phase 3 Validation of Ovarian Cancer Serum Markers in Preclinical WHI Samples — EDRN Public Portal

Cancer.gov

The WHI offers an opportunity to evaluate ovarian cancer markers and screening decision rules developed and validated in EDRN CVC Studies 2 and 3 in women who were not being screened. It is particularly well suited to validation of risk markers, since many serum samples were drawn well before clinical diagnosis of cancer in the WHI cohorts. A strategy is needed to identify from among the general population of women over the age of 50 those at high-risk for a diagnosis of ovarian/fallopian tube cancer so that they can be referred for appropriate surveillance, imaging or surgical consult. Tools to identify high-risk women will be investigated including serum markers CA125, HE4, MSLN, and MMP7 and epidemiologic risk factors. We will optimize decision rules using stored serum samples from the WHI OS and conduct a simulated prospective validation using stored serum samples from the WHI CT. Decision rules to select women for ovarian cancer screening will be investigated as well as decision rules for use in ovarian cancer screening.

Translation, validation, and cultural adaptation of the Rhinosinusitis Disability Index and the Chronic Sinusitis Survey into Arabic.

PubMed

Aldrees, Turki; Almubarak, Zaid; Hassouneh, Basil; Albosaily, Ahamed; Aloulah, Mohammad; Almasoud, Mai; Alsaleh, Saad

2018-01-01

Disease-specific quality of life instruments assess the impact of chronic rhinosinusitis on patients' quality of life (QoL). To the extent of our knowledge, there are no Arabic versions of two instruments-the Rhinosinusitis Disability Index (RSDI) and the Chronic Sinusitis Survey (CSS). Develop an Arabic-validated version of both instruments, thus allowing its use among the Arabic population. Prospective cross-sectional study for instrument validation. Tertiary university hospital. This study was conducted between September 2015 and October 2016. We followed the international comprehensive guidelines for translation and cross-cultural adaptation of QoL instruments. Test-retest reliability, discriminant validity, and responsiveness ability of both the RSDI and CSS Arabic versions. 124. The sample comprised 75 patients diagnosed with chronic rhinosinusitis and 49 healthy control subjects. The Arabic version of both instruments showed high internal consistency (Cronbach's alpha: RSDI=0.97, CSS=.88) and the ability to differentiate between diseased and healthy volunteers (P less than .0001). The translated versions also detected significant change in response to an intervention (P less than .0001). These Arabic validated versions of the RSDI and CSS can be used for both clinical and research purposes. This study was performed in only one tertiary hospital. None.

A French validation study of the Coma Recovery Scale-Revised (CRS-R).

PubMed

Schnakers, Caroline; Majerus, Steve; Giacino, Joseph; Vanhaudenhuyse, Audrey; Bruno, Marie-Aurelie; Boly, Melanie; Moonen, Gustave; Damas, Pierre; Lambermont, Bernard; Lamy, Maurice; Damas, Francois; Ventura, Manfredi; Laureys, Steven

2008-09-01

The aim of the present study was to explore the concurrent validity, inter-rater agreement and diagnostic sensitivity of a French adaptation of the Coma Recovery Scale-Revised (CRS-R) as compared to other coma scales such as the Glasgow Coma Scale (GCS), the Full Outline of UnResponsiveness scale (FOUR) and the Wessex Head Injury Matrix (WHIM). Multi-centric prospective study. To test concurrent validity and diagnostic sensitivity, the four behavioural scales were administered in a randomized order in 77 vegetative and minimally conscious patients. Twenty-four clinicians with different professional backgrounds, levels of expertise and CRS-R experience were recruited to assess inter-rater agreement. Good concurrent validity was obtained between the CRS-R and the three other standardized behavioural scales. Inter-rater reliability for the CRS-R total score and sub-scores was good, indicating that the scale yields reproducible findings across examiners and does not appear to be systematically biased by profession, level of expertise or CRS-R experience. Finally, the CRS-R demonstrated a significantly higher sensitivity to detect MCS patients, as compared to the GCS, the FOUR and the WHIM. The results show that the French version of the CRS-R is a valid and sensitive scale which can be used in severely brain damaged patients by all members of the medical staff.

Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

PubMed

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2014-02-01

Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

Updating and prospective validation of a prognostic model for high sickness absence.

PubMed

Roelen, C A M; Heymans, M W; Twisk, J W R; van Rhenen, W; Pallesen, S; Bjorvatn, B; Moen, B E; Magerøy, N

2015-01-01

To further develop and validate a Dutch prognostic model for high sickness absence (SA). Three-wave longitudinal cohort study of 2,059 Norwegian nurses. The Dutch prognostic model was used to predict high SA among Norwegian nurses at wave 2. Subsequently, the model was updated by adding person-related (age, gender, marital status, children at home, and coping strategies), health-related (BMI, physical activity, smoking, and caffeine and alcohol intake), and work-related (job satisfaction, job demands, decision latitude, social support at work, and both work-to-family and family-to-work spillover) variables. The updated model was then prospectively validated for predictions at wave 3. 1,557 (77 %) nurses had complete data at wave 2 and 1,342 (65 %) at wave 3. The risk of high SA was under-estimated by the Dutch model, but discrimination between high-risk and low-risk nurses was fair after re-calibration to the Norwegian data. Gender, marital status, BMI, physical activity, smoking, alcohol intake, job satisfaction, job demands, decision latitude, support at the workplace, and work-to-family spillover were identified as potential predictors of high SA. However, these predictors did not improve the model's discriminative ability, which remained fair at wave 3. The prognostic model correctly identifies 73 % of Norwegian nurses at risk of high SA, although additional predictors are needed before the model can be used to screen working populations for risk of high SA.

Predicting sugar-sweetened behaviours with theory of planned behaviour constructs: Outcome and process results from the SIPsmartER behavioural intervention.

PubMed

Zoellner, Jamie M; Porter, Kathleen J; Chen, Yvonnes; Hedrick, Valisa E; You, Wen; Hickman, Maja; Estabrooks, Paul A

2017-05-01

Guided by the theory of planned behaviour (TPB) and health literacy concepts, SIPsmartER is a six-month multicomponent intervention effective at improving SSB behaviours. Using SIPsmartER data, this study explores prediction of SSB behavioural intention (BI) and behaviour from TPB constructs using: (1) cross-sectional and prospective models and (2) 11 single-item assessments from interactive voice response (IVR) technology. Quasi-experimental design, including pre- and post-outcome data and repeated-measures process data of 155 intervention participants. Validated multi-item TPB measures, single-item TPB measures, and self-reported SSB behaviours. Hypothesised relationships were investigated using correlation and multiple regression models. TPB constructs explained 32% of the variance cross sectionally and 20% prospectively in BI; and explained 13-20% of variance cross sectionally and 6% prospectively. Single-item scale models were significant, yet explained less variance. All IVR models predicting BI (average 21%, range 6-38%) and behaviour (average 30%, range 6-55%) were significant. Findings are interpreted in the context of other cross-sectional, prospective and experimental TPB health and dietary studies. Findings advance experimental application of the TPB, including understanding constructs at outcome and process time points and applying theory in all intervention development, implementation and evaluation phases.

Blood eosinophil count thresholds and exacerbations in patients with chronic obstructive pulmonary disease.

PubMed

Yun, Jeong H; Lamb, Andrew; Chase, Robert; Singh, Dave; Parker, Margaret M; Saferali, Aabida; Vestbo, Jørgen; Tal-Singer, Ruth; Castaldi, Peter J; Silverman, Edwin K; Hersh, Craig P

2018-06-01

Eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD) is associated with exacerbations and responsivity to steroids, suggesting potential shared mechanisms with eosinophilic asthma. However, there is no consistent blood eosinophil count that has been used to define the increased exacerbation risk. We sought to investigate blood eosinophil counts associated with exacerbation risk in patients with COPD. Blood eosinophil counts and exacerbation risk were analyzed in patients with moderate-to-severe COPD by using 2 independent studies of former and current smokers with longitudinal data. The Genetic Epidemiology of COPD (COPDGene) study was analyzed for discovery (n = 1,553), and the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was analyzed for validation (n = 1,895). A subset of the ECLIPSE study subjects were used to assess the stability of blood eosinophil counts over time. COPD exacerbation risk increased with higher eosinophil counts. An eosinophil count threshold of 300 cells/μL or greater showed adjusted incidence rate ratios for exacerbations of 1.32 in the COPDGene study (95% CI, 1.10-1.63). The cutoff of 300 cells/μL or greater was validated for prospective risk of exacerbation in the ECLIPSE study, with adjusted incidence rate ratios of 1.22 (95% CI, 1.06-1.41) using 3-year follow-up data. Stratified analysis confirmed that the increased exacerbation risk associated with an eosinophil count of 300 cells/μL or greater was driven by subjects with a history of frequent exacerbations in both the COPDGene and ECLIPSE studies. Patients with moderate-to-severe COPD and blood eosinophil counts of 300 cells/μL or greater had an increased risk exacerbations in the COPDGene study, which was prospectively validated in the ECLIPSE study. Copyright © 2018 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

CORRELATES OF RECOVERY FROM ALCOHOL DEPENDENCE: A PROSPECTIVE STUDY OVER A 3-YEAR FOLLOW-UP INTERVAL

PubMed Central

Dawson, Deborah A.; Goldstein, Risë B.; Ruan, W. June; Grant, Bridget F.

2011-01-01

Background Correlates of recovery from alcohol dependence have been identified through a variety of study designs characterized by different strengths and limitations. The goal of this study was to compare correlates of recovery based on a 3-year prospective design with those based on cross-sectional analyses of data from the same source. Methods Data from the 2001-2002 Wave 1 and 2004-2005 Wave 2 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) were used to examine baseline characteristics associated with Wave 2 recovery from alcohol dependence, among those who classified with past-year DSM-IV alcohol dependence at Wave 1 (n=1,172). Results Abstinent recovery (AR) was significantly associated with Black/Asian/Hispanic race/ethnicity, children <1 year of age in the household at baseline, attending religious services ≥weekly at follow-up, and having initiated help seeking that comprised/included 12-step participation within <3 years prior to baseline. Nonabstinent recovery (NR) was positively associated with being never married at baseline, having job problems or being unemployed in the year preceding baseline, attending religious services

Novel Signs and Their Clinical Utility in Diagnosing Complex Regional Pain Syndrome (CRPS): A Prospective Observational Cohort Study.

PubMed

Kuttikat, Anoop; Shaikh, Maliha; Oomatia, Amin; Parker, Richard; Shenker, Nicholas

2017-06-01

Delays in diagnosis occur with complex regional pain syndrome (CRPS). We define and prospectively demonstrate that novel bedside tests measuring body perception disruption can identify patients with CRPS postfracture. The objectives of our study were to define and validate 4 bedside tests, to identify the prevalence of positive tests in patients with CRPS and other chronic pain conditions, and to assess the clinical utility (sensitivity, specificity, positive predictive value, negative predictive value) for identifying CRPS within a Fracture cohort. This was a single UK teaching hospital prospective cohort study with 313 recruits from pain-free volunteers and patients with chronic pain conditions.Four novel tests were Finger Perception (FP), Hand Laterality identification (HL), Astereognosis (AS), and Body Scheme (BS) report. Five questionnaires (Brief Pain Inventory, Upper Extremity Functional Index, Lower Extremity Functional Index, Neglect-like Symptom Questionnaire, Hospital Anxiety and Depression Score) assessed the multidimensional pain experience. FP and BS were the best performing tests. Prospective monitoring of fracture patients showed that out of 7 fracture patients (total n=47) who had both finger misperception and abnormal BS report at initial testing, 3 developed persistent pain with 1 having a formal diagnosis of CRPS. Novel signs are reliable, easy to perform, and present in chronic pain patients. FP and BS have significant clinical utility in predicting persistent pain in a fracture group thereby allowing targeted early intervention.

A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.

PubMed

Donovan, Jenny L; Young, Grace J; Walsh, Eleanor I; Metcalfe, Chris; Lane, J Athene; Martin, Richard M; Tazewell, Marta K; Davis, Michael; Peters, Tim J; Turner, Emma L; Mills, Nicola; Khazragui, Hanan; Khera, Tarnjit K; Neal, David E; Hamdy, Freddie C

2018-04-01

Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. Population-based cluster randomization created a prospective study of prostate-specific antigen (PSA) testing and a comprehensive-cohort study including groups choosing treatment or excluded from the RCT, as well as those randomized. Baseline information assessed selection and response during RCT conduct. The prospective study (82,430 PSA-tested men) represented healthy men likely to respond to a screening invitation. The extended comprehensive cohort comprised 1,643 randomized, 997 choosing treatment, and 557 excluded with advanced cancer/comorbidities. Men choosing treatment were very similar to randomized men except for having more professional/managerial occupations. Excluded men were similar to the randomized socio-demographically but different clinically, representing less healthy men with more advanced PCa. The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Impulsivity-hyperactivity and subtypes of aggression in early childhood: an observational and short-term longitudinal study.

PubMed

Ostrov, Jamie M; Godleski, Stephanie A

2009-08-01

This short-term longitudinal study (N = 112) was conducted to explore the concurrent and prospective associations between teacher-reported impulsive-hyperactive behavior and observed relational and physical aggression during early childhood (M = 45.54 months old, SD = 9.07). Multiple informants and methods including observational methods (i.e., 160 min per child) were used to assess aggression and impulsivity-hyperactivity. All measures were found to be valid and reliable. Prospective hierarchical regression analyses revealed that impulsivity-hyperactivity was associated with increases in observed physical aggression across time, controlling for initial relational aggression and gender. These findings add to the growing developmental psychopathology literature that suggests that distinguishing between subtypes of aggression during early childhood may be important for understanding the course of impulsivity-hyperactivity in young children. Implications for practice are discussed.

The Development and Validation of a Concise Instrument for Formative Assessment of Team Leader Performance During Simulated Pediatric Resuscitations.

PubMed

Nadkarni, Lindsay D; Roskind, Cindy G; Auerbach, Marc A; Calhoun, Aaron W; Adler, Mark D; Kessler, David O

2018-04-01

The aim of this study was to assess the validity of a formative feedback instrument for leaders of simulated resuscitations. This is a prospective validation study with a fully crossed (person × scenario × rater) study design. The Concise Assessment of Leader Management (CALM) instrument was designed by pediatric emergency medicine and graduate medical education experts to be used off the shelf to evaluate and provide formative feedback to resuscitation leaders. Four experts reviewed 16 videos of in situ simulated pediatric resuscitations and scored resuscitation leader performance using the CALM instrument. The videos consisted of 4 pediatric emergency department resuscitation teams each performing in 4 pediatric resuscitation scenarios (cardiac arrest, respiratory arrest, seizure, and sepsis). We report on content and internal structure (reliability) validity of the CALM instrument. Content validity was supported by the instrument development process that involved professional experience, expert consensus, focused literature review, and pilot testing. Internal structure validity (reliability) was supported by the generalizability analysis. The main component that contributed to score variability was the person (33%), meaning that individual leaders performed differently. The rater component had almost zero (0%) contribution to variance, which implies that raters were in agreement and argues for high interrater reliability. These results provide initial evidence to support the validity of the CALM instrument as a reliable assessment instrument that can facilitate formative feedback to leaders of pediatric simulated resuscitations.

UK-based prospective cohort study to anglicise and validate the FACE-Q Skin Cancer Module in patients with facial skin cancer undergoing surgical reconstruction: the PROMISCR (Patient-Reported Outcome Measure in Skin Cancer Reconstruction) study.

PubMed

Dobbs, Thomas; Hutchings, Hayley A; Whitaker, Iain S

2017-09-24

Skin cancer is the most common malignancy worldwide, often occurring on the face, where the cosmetic outcome of treatment is paramount. A number of skin cancer-specific patient-reported outcome measures (PROMs) exist, however none adequately consider the difference in type of reconstruction from a patient's point of view. It is the aim of this study to 'anglicise' (to UK English) a recently developed US PROM for facial skin cancer (the FACE-Q Skin Cancer Module) and to validate this UK version of the PROM. The validation will also involve an assessment of the items for relevance to facial reconstruction patients. This will either validate this new measure for the use in clinical care and research of various facial reconstructive options, or provide evidence that a more specific PROM is required. This is a prospective validation study of the FACE-Q Skin Cancer Module in a UK facial skin cancer population with a specific focus on the difference between types of reconstruction. The face and content validity of the FACE-Q questionnaire will initially be assessed by a review process involving patients, skin cancer specialists and methodologists. An assessment of whether questions are relevant and any missing questions will be made. Initial validation will then be carried out by recruiting a cohort of 100 study participants with skin cancer of the face pre-operatively. All eligible patients will be invited to complete the questionnaire preoperatively and postoperatively. Psychometric analysis will be performed to test validity, reliability and responsiveness to change. Subgroup analysis will be performed on patients undergoing different forms of reconstruction postexcision of their skin cancer. This study has been approved by the West Midlands, Edgbaston Research Ethics Committee (Ref 16/WM/0445). All personal data collected will be anonymised and patient-specific data will only be reported in terms of group demographics. Identifiable data collected will include the patient name and date of birth. Other collected personal data will include their diagnosis, treatment performed, method of reconstruction and complications. A unique identifier will be applied to each patient so that pretreatment and post-treatment questionnaire results can be compared. All data acquisition and storage will be in accordance with the Data Protection Act 1998. Following completion of the study, all records will be stored in the Abertawe Bro Morgannwg University (AMBU) Health Board archive facility. Only qualified personnel working on the project will have access to the data.The outputs from this work will be published as widely as possible in peer-review journals and it is our aim to make this open access. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

NLP based congestive heart failure case finding: A prospective analysis on statewide electronic medical records.

PubMed

Wang, Yue; Luo, Jin; Hao, Shiying; Xu, Haihua; Shin, Andrew Young; Jin, Bo; Liu, Rui; Deng, Xiaohong; Wang, Lijuan; Zheng, Le; Zhao, Yifan; Zhu, Chunqing; Hu, Zhongkai; Fu, Changlin; Hao, Yanpeng; Zhao, Yingzhen; Jiang, Yunliang; Dai, Dorothy; Culver, Devore S; Alfreds, Shaun T; Todd, Rogow; Stearns, Frank; Sylvester, Karl G; Widen, Eric; Ling, Xuefeng B

2015-12-01

In order to proactively manage congestive heart failure (CHF) patients, an effective CHF case finding algorithm is required to process both structured and unstructured electronic medical records (EMR) to allow complementary and cost-efficient identification of CHF patients. We set to identify CHF cases from both EMR codified and natural language processing (NLP) found cases. Using narrative clinical notes from all Maine Health Information Exchange (HIE) patients, the NLP case finding algorithm was retrospectively (July 1, 2012-June 30, 2013) developed with a random subset of HIE associated facilities, and blind-tested with the remaining facilities. The NLP based method was integrated into a live HIE population exploration system and validated prospectively (July 1, 2013-June 30, 2014). Total of 18,295 codified CHF patients were included in Maine HIE. Among the 253,803 subjects without CHF codings, our case finding algorithm prospectively identified 2411 uncodified CHF cases. The positive predictive value (PPV) is 0.914, and 70.1% of these 2411 cases were found to be with CHF histories in the clinical notes. A CHF case finding algorithm was developed, tested and prospectively validated. The successful integration of the CHF case findings algorithm into the Maine HIE live system is expected to improve the Maine CHF care. Copyright © 2015. Published by Elsevier Ireland Ltd.

The diagnosis of urinary tract infections in young children (DUTY): protocol for a diagnostic and prospective observational study to derive and validate a clinical algorithm for the diagnosis of UTI in children presenting to primary care with an acute illness.

PubMed

Downing, Harriet; Thomas-Jones, Emma; Gal, Micaela; Waldron, Cherry-Ann; Sterne, Jonathan; Hollingworth, William; Hood, Kerenza; Delaney, Brendan; Little, Paul; Howe, Robin; Wootton, Mandy; Macgowan, Alastair; Butler, Christopher C; Hay, Alastair D

2012-07-19

Urinary tract infection (UTI) is common in children, and may cause serious illness and recurrent symptoms. However, obtaining a urine sample from young children in primary care is challenging and not feasible for large numbers. Evidence regarding the predictive value of symptoms, signs and urinalysis for UTI in young children is urgently needed to help primary care clinicians better identify children who should be investigated for UTI. This paper describes the protocol for the Diagnosis of Urinary Tract infection in Young children (DUTY) study. The overall study aim is to derive and validate a cost-effective clinical algorithm for the diagnosis of UTI in children presenting to primary care acutely unwell. DUTY is a multicentre, diagnostic and prospective observational study aiming to recruit at least 7,000 children aged before their fifth birthday, being assessed in primary care for any acute, non-traumatic, illness of ≤ 28 days duration. Urine samples will be obtained from eligible consented children, and data collected on medical history and presenting symptoms and signs. Urine samples will be dipstick tested in general practice and sent for microbiological analysis. All children with culture positive urines and a random sample of children with urine culture results in other, non-positive categories will be followed up to record symptom duration and healthcare resource use. A diagnostic algorithm will be constructed and validated and an economic evaluation conducted.The primary outcome will be a validated diagnostic algorithm using a reference standard of a pure/predominant growth of at least >103, but usually >105 CFU/mL of one, but no more than two uropathogens.We will use logistic regression to identify the clinical predictors (i.e. demographic, medical history, presenting signs and symptoms and urine dipstick analysis results) most strongly associated with a positive urine culture result. We will then use economic evaluation to compare the cost effectiveness of the candidate prediction rules. This study will provide novel, clinically important information on the diagnostic features of childhood UTI and the cost effectiveness of a validated prediction rule, to help primary care clinicians improve the efficiency of their diagnostic strategy for UTI in young children.

The diagnosis of urinary tract infections in young children (DUTY): protocol for a diagnostic and prospective observational study to derive and validate a clinical algorithm for the diagnosis of UTI in children presenting to primary care with an acute illness

PubMed Central

2012-01-01

Background Urinary tract infection (UTI) is common in children, and may cause serious illness and recurrent symptoms. However, obtaining a urine sample from young children in primary care is challenging and not feasible for large numbers. Evidence regarding the predictive value of symptoms, signs and urinalysis for UTI in young children is urgently needed to help primary care clinicians better identify children who should be investigated for UTI. This paper describes the protocol for the Diagnosis of Urinary Tract infection in Young children (DUTY) study. The overall study aim is to derive and validate a cost-effective clinical algorithm for the diagnosis of UTI in children presenting to primary care acutely unwell. Methods/design DUTY is a multicentre, diagnostic and prospective observational study aiming to recruit at least 7,000 children aged before their fifth birthday, being assessed in primary care for any acute, non-traumatic, illness of ≤ 28 days duration. Urine samples will be obtained from eligible consented children, and data collected on medical history and presenting symptoms and signs. Urine samples will be dipstick tested in general practice and sent for microbiological analysis. All children with culture positive urines and a random sample of children with urine culture results in other, non-positive categories will be followed up to record symptom duration and healthcare resource use. A diagnostic algorithm will be constructed and validated and an economic evaluation conducted. The primary outcome will be a validated diagnostic algorithm using a reference standard of a pure/predominant growth of at least >103, but usually >105 CFU/mL of one, but no more than two uropathogens. We will use logistic regression to identify the clinical predictors (i.e. demographic, medical history, presenting signs and symptoms and urine dipstick analysis results) most strongly associated with a positive urine culture result. We will then use economic evaluation to compare the cost effectiveness of the candidate prediction rules. Discussion This study will provide novel, clinically important information on the diagnostic features of childhood UTI and the cost effectiveness of a validated prediction rule, to help primary care clinicians improve the efficiency of their diagnostic strategy for UTI in young children. PMID:22812651

Bayesian networks: a new method for the modeling of bibliographic knowledge: application to fall risk assessment in geriatric patients.

PubMed

Lalande, Laure; Bourguignon, Laurent; Carlier, Chloé; Ducher, Michel

2013-06-01

Falls in geriatry are associated with important morbidity, mortality and high healthcare costs. Because of the large number of variables related to the risk of falling, determining patients at risk is a difficult challenge. The aim of this work was to validate a tool to detect patients with high risk of fall using only bibliographic knowledge. Thirty articles corresponding to 160 studies were used to modelize fall risk. A retrospective case-control cohort including 288 patients (88 ± 7 years) and a prospective cohort including 106 patients (89 ± 6 years) from two geriatric hospitals were used to validate the performances of our model. We identified 26 variables associated with an increased risk of fall. These variables were split into illnesses, medications, and environment. The combination of the three associated scores gives a global fall score. The sensitivity and the specificity were 31.4, 81.6, 38.5, and 90 %, respectively, for the retrospective and the prospective cohort. The performances of the model are similar to results observed with already existing prediction tools using model adjustment to data from numerous cohort studies. This work demonstrates that knowledge from the literature can be synthesized with Bayesian networks.

Workflow interruptions and mental workload in hospital pediatricians: an observational study.

PubMed

Weigl, Matthias; Müller, Andreas; Angerer, Peter; Hoffmann, Florian

2014-09-24

Pediatricians' workload is increasingly thought to affect pediatricians' quality of work life and patient safety. Workflow interruptions are a frequent stressor in clinical work, impeding clinicians' attention and contributing to clinical malpractice. We aimed to investigate prospective associations of workflow interruptions with multiple dimensions of mental workload in pediatricians during clinical day shifts. In an Academic Children's Hospital a prospective study of 28 full shift observations was conducted among pediatricians providing ward coverage. The prevalence of workflow interruptions was based on expert observation using a validated observation instrument. Concurrently, Pediatricians' workload ratings were assessed with three workload dimensions of the well-validated NASA-Task Load Index: mental demands, effort, and frustration. Observed pediatricians were, on average, disrupted 4.7 times per hour. Most frequent were interruptions by colleagues (30.2%), nursing staff (29.7%), and by telephone/beeper calls (16.3%). Interruption measures were correlated with two workload outcomes of interest: frequent workflow interruptions were related to less cognitive demands, but frequent interruptions were associated with increased frustration. With regard to single sources, interruptions by colleagues showed the strongest associations to workload. The findings provide insights into specific pathways between different types of interruptions and pediatricians' mental workload. These findings suggest further research and yield a number of work and organization re-design suggestions for pediatric care.

Development of the Sydney Falls Risk Screening Tool in brain injury rehabilitation: A multisite prospective cohort study.

PubMed

McKechnie, Duncan; Fisher, Murray J; Pryor, Julie; Bonser, Melissa; Jesus, Jhoven De

2018-03-01

To develop a falls risk screening tool (FRST) sensitive to the traumatic brain injury rehabilitation population. Falls are the most frequently recorded patient safety incident within the hospital context. The inpatient traumatic brain injury rehabilitation population is one particular population that has been identified as at high risk of falls. However, no FRST has been developed for this patient population. Consequently in the traumatic brain injury rehabilitation population, there is the real possibility that nurses are using falls risk screening tools that have a poor clinical utility. Multisite prospective cohort study. Univariate and multiple logistic regression modelling techniques (backward elimination, elastic net and hierarchical) were used to examine each variable's association with patients who fell. The resulting FRST's clinical validity was examined. Of the 140 patients in the study, 41 (29%) fell. Through multiple logistic regression modelling, 11 variables were identified as predictors for falls. Using hierarchical logistic regression, five of these were identified for inclusion in the resulting falls risk screening tool: prescribed mobility aid (such as, wheelchair or frame), a fall since admission to hospital, impulsive behaviour, impaired orientation and bladder and/or bowel incontinence. The resulting FRST has good clinical validity (sensitivity = 0.9; specificity = 0.62; area under the curve = 0.87; Youden index = 0.54). The tool was significantly more accurate (p = .037 on DeLong test) in discriminating fallers from nonfallers than the Ontario Modified STRATIFY FRST. A FRST has been developed using a comprehensive statistical framework, and evidence has been provided of this tool's clinical validity. The developed tool, the Sydney Falls Risk Screening Tool, should be considered for use in brain injury rehabilitation populations. © 2017 John Wiley & Sons Ltd.

A prospective, multi-method, multi-disciplinary, multi-level, collaborative, social-organisational design for researching health sector accreditation [LP0560737

PubMed Central

Braithwaite, Jeffrey; Westbrook, Johanna; Pawsey, Marjorie; Greenfield, David; Naylor, Justine; Iedema, Rick; Runciman, Bill; Redman, Sally; Jorm, Christine; Robinson, Maureen; Nathan, Sally; Gibberd, Robert

2006-01-01

Background Accreditation has become ubiquitous across the international health care landscape. Award of full accreditation status in health care is viewed, as it is in other sectors, as a valid indicator of high quality organisational performance. However, few studies have empirically demonstrated this assertion. The value of accreditation, therefore, remains uncertain, and this persists as a central legitimacy problem for accreditation providers, policymakers and researchers. The question arises as to how best to research the validity, impact and value of accreditation processes in health care. Most health care organisations participate in some sort of accreditation process and thus it is not possible to study its merits using a randomised controlled strategy. Further, tools and processes for accreditation and organisational performance are multifaceted. Methods/design To understand the relationship between them a multi-method research approach is required which incorporates both quantitative and qualitative data. The generic nature of accreditation standard development and inspection within different sectors enhances the extent to which the findings of in-depth study of accreditation process in one industry can be generalised to other industries. This paper presents a research design which comprises a prospective, multi-method, multi-level, multi-disciplinary approach to assess the validity, impact and value of accreditation. Discussion The accreditation program which assesses over 1,000 health services in Australia is used as an exemplar for testing this design. The paper proposes this design as a framework suitable for application to future international research into accreditation. Our aim is to stimulate debate on the role of accreditation and how to research it. PMID:16968552

Chinese herbal medicine for the treatment of Henoch-Schönlein purpura nephritis in children: A prospective cohort study protocol.

PubMed

Zhang, Jun; Lv, Jing; Pang, Shuang; Bai, Xiaohong; Yuan, Fang; Wu, Yubin; Jiang, Hong; Yang, Guanqi; Zhang, Shaoqing

2018-06-01

Henoch-Schönlein purpura nephritis (HSPN) involves the renal impairment of Henoch-Schönlein purpura and can easily relapse into life-threatening late nephropathy in severe cases. Although there is a lack of validated evidence for its effectiveness, Chinese herbal medicine (CHM) is one of the most commonly used methods in China to treat HSPN. It is thus need to report the protocol of a prospective cohort trial using CHM to investigate the effectiveness, safety and advantages for children with HSPN. This large, prospective, multicenter cohort study started in May 2015 in Shenyang. Six hundred children diagnosed with HSPN were recruited from 3 institutions and are followed-up every 2 to 4 weeks till May 2020. Detailed information of participants includes general information, history of treatment, physical examination, and symptoms of TCM is taken face-to-face at baseline. This study has received ethical approval from the ethics committee of institutional review board of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine (No.2016CS(KT)-002-01). Articles summarizing the primary results and ancillary analyses will be published in peer-reviewed journals. Clinical Trials Registration: NCT02878018.

Windmill-task as a New Quantitative and Objective Assessment for Mirror Movements in Unilateral Cerebral Palsy: A Pilot Study.

PubMed

Zielinski, Ingar Marie; Steenbergen, Bert; Schmidt, Anna; Klingels, Katrijn; Simon Martinez, Cristina; de Water, Pascal; Hoare, Brian

2018-03-23

To introduce the Windmill-task, a new objective assessment tool to quantify the presence of mirror movements (MMs) in children with unilateral cerebral palsy (UCP), which are typically assessed with the observation-based Woods and Teuber scale (W&T). Prospective, observational, cohort pilot study. Children's hospital. Prospective cohort of children (N=23) with UCP (age range, 6-15y, mean age, 10.5±2.7y). Not applicable. The concurrent validity of the Windmill-task is assessed, and the sensitivity and specificity for MM detection are compared between both assessments. To assess the concurrent validity, Windmill-task data are compared with W&T data using Spearman rank correlations (ρ) for 2 conditions: affected hand moving vs less affected hand moving. Sensitivity and specificity are compared by measuring the mean percentage of children being assessed inconsistently across both assessments. Outcomes of both assessments correlated significantly (affected hand moving: ρ=.520; P=.005; less affected hand moving: ρ=.488; P=.009). However, many children displayed MMs on the Windmill-task, but not on the W&T (sensitivity: affected hand moving: 27.5%; less affected hand moving: 40.6%). Only 2 children displayed MMs on the W&T, but not on the Windmill-task (specificity: affected hand moving: 2.9%; less affected hand moving: 1.4%). The Windmill-task seems to be a valid tool to assess MMs in children with UCP and has an additional advantage of sensitivity to detect MMs. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Prospective Study Validating Inter- and Intraobserver Variability of Tissue Compliance Meter in Breast Tissue of Healthy Volunteers: Potential Implications for Patients With Radiation-Induced Fibrosis of the Breast

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

Wernicke, A. Gabriella, E-mail: gaw9008@med.cornell.ed; Parashar, Bhupesh; Kulidzhanov, Fridon

2011-05-01

Purpose: Accurate detection of radiation-induced fibrosis (RIF) is crucial in management of breast cancer survivors. Tissue compliance meter (TCM) has been validated in musculature. We validate TCM in healthy breast tissue with respect to interobserver and intraobserver variability before applying it in RIF. Methods and Materials: Three medical professionals obtained three consecutive TCM measurements in each of the four quadrants of the right and left breasts of 40 women with no breast disease or surgical intervention. The intraclass correlation coefficient (ICC) assessed interobserver variability. The paired t test and Pearson correlation coefficient (r) were used to assess intraobserver variability withinmore » each rater. Results: The median age was 45 years (range, 24-68 years). The median bra size was 35C (range, 32A-40DD). Of the participants, 27 were white (67%), 4 black (10%), 5 Asian (13%), and 4 Hispanic (10%). ICCs indicated excellent interrater reliability (low interobserver variability) among the three raters, by breast and quadrant (all ICC {>=}0.99). The paired t test and Pearson correlation coefficient both indicated low intraobserver variability within each rater (right vs. left breast), stratified by quadrant (all r{>=} 0.94, p < 0.0001). Conclusions: The interobserver and intraobserver variability is small using TCM in healthy mammary tissue. We are now embarking on a prospective study using TCM in women with breast cancer at risk of developing RIF that may guide early detection, timely therapeutic intervention, and assessment of success of therapy for RIF.« less

Secondary school physics teachers' conceptions of scientific evidence: A collective case study

NASA Astrophysics Data System (ADS)

Taylor, Joseph A.

Engaging secondary school students in inquiry-oriented tasks that more closely simulate the scholarly activities of scientists has been recommended as a way to improve scientific literacy. Two tasks that are frequently recommended include students' design of original experiments, and students' evaluation of scientific evidence and conclusions. Yet, little is known about teachers' conceptions of experimentation. The principal aim of this study, therefore, was to describe the nature of prospective and practicing physics teachers' conceptions of scientific evidence. More specifically, the following research questions guided this study: (1) What types of issues related to the measurement reliability and experimental validity of scientific evidence do practicing and prospective physics teachers think about when designing experiments? (2) When presented with hypothetical scenarios that describe unsound experimental procedures or poorly supported conclusions (or both), what concerns will prospective and practicing physics teachers raise? And (3) When the participants' responses to parallel research prompts are compared across protocols, what similarities and differences exist? The nature of the teacher-participants' conceptions was described from an analysis of data collected from research prompts such as interviews and hand written artifacts. In these research prompts, the teachers "thought aloud" while designing experiments and critically evaluated student-collected evidence presented in hypothetical classroom scenarios. The data from this study suggested that the three teachers, while contemplating the reliability and validity of scientific evidence, frequently used their conceptions of evidence in conjunction with specific subject matter conceptions. The data also indicated that the relationship between subject matter knowledge and conceptions of evidence was more pronounced for some conceptions of evidence than for others. Suggestions for future research included conducting similar studies in other physics content areas as well as other scientific disciplines. Implications for science teacher education suggested that science and science methods courses encourage the construction of evidence-based arguments, as well as engagement in peer review and critique.

Clinical validation of a public health policy-making platform for hearing loss (EVOTION): protocol for a big data study

PubMed Central

Kikidis, Dimitris; Koloutsou, Nina; Murdin, Louisa; Bibas, Athanasios; Ploumidou, Katherine; Laplante-Lévesque, Ariane; Pontoppidan, Niels Henrik; Bamiou, Doris-Eva

2018-01-01

Introduction The holistic management of hearing loss (HL) requires an understanding of factors that predict hearing aid (HA) use and benefit beyond the acoustics of listening environments. Although several predictors have been identified, no study has explored the role of audiological, cognitive, behavioural and physiological data nor has any study collected real-time HA data. This study will collect ‘big data’, including retrospective HA logging data, prospective clinical data and real-time data via smart HAs, a mobile application and biosensors. The main objective is to enable the validation of the EVOTION platform as a public health policy-making tool for HL. Methods and analysis This will be a big data international multicentre study consisting of retrospective and prospective data collection. Existing data from approximately 35 000 HA users will be extracted from clinical repositories in the UK and Denmark. For the prospective data collection, 1260 HA candidates will be recruited across four clinics in the UK and Greece. Participants will complete a battery of audiological and other assessments (measures of patient-reported HA benefit, mood, cognition, quality of life). Patients will be offered smart HAs and a mobile phone application and a subset will also be given wearable biosensors, to enable the collection of dynamic real-life HA usage data. Big data analytics will be used to detect correlations between contextualised HA usage and effectiveness, and different factors and comorbidities affecting HL, with a view to informing public health decision-making. Ethics and dissemination Ethical approval was received from the London South East Research Ethics Committee (17/LO/0789), the Hippokrateion Hospital Ethics Committee (1847) and the Athens Medical Center’s Ethics Committee (KM140670). Results will be disseminated through national and international events in Greece and the UK, scientific journals, newsletters, magazines and social media. Target audiences include HA users, clinicians, policy-makers and the general public. Trial registration number NCT03316287; Pre-results. PMID:29449298

Online or on Campus: A Student Tertiary Education Cost Model Comparing the Two, with a Quality Proviso

ERIC Educational Resources Information Center

Ioakimidis, Marilou

2007-01-01

This paper presents the development and validation of a two-level hierarchical cost model for tertiary education, which enables prospective students to compare the total cost of attending a traditional Baccalaureate degree education with that of the same programme taken through distance e-learning. The model was validated by a sample of Greek…

Providing Written Feedback on Students' Mathematical Arguments: Proof Validations of Prospective Secondary Mathematics Teachers

ERIC Educational Resources Information Center

Bleiler, Sarah K.; Thompson, Denisse R.; Krajcevski, Milé

2014-01-01

Mathematics teachers play a unique role as experts who provide opportunities for students to engage in the practices of the mathematics community. Proof is a tool essential to the practice of mathematics, and therefore, if teachers are to provide adequate opportunities for students to engage with this tool, they must be able to validate student…

Validity of retrospective disease activity assessment in systemic lupus erythematosus.

PubMed

Arce-Salinas, A; Cardiel, M H; Guzmán, J; Alcocer-Varela, J

1996-05-01

To evaluate the validity of retrospective disease activity assessment derived from clinical charts. We prospectively evaluated 37 patients with systemic lupus erythematosus (SLE) in 90 visits using the SLE Disease Activity Index (SLEDAI), the Mexican SLEDAI (Mex-SLEDAI), and the Lupus Activity Criteria Count (LACC) indices. Routine clinical observations were written by rheumatologists blind to index scores. These notes were reviewed 2 years later to obtain retrospective index scores and their validity was assessed using prospective scores as the standard. Statistical analysis was by Spearman's rank correlation coefficient (rs), Wilcoxon matched pairs test, kappa statistic, and intraclass correlation coefficient (ri). We calculated the sensitivity and specificity of retrospective indices to detect active disease. Median retrospective scores were lower in all indices: SLEDAI (4 VS 2, p =0.004, RS = 0.68, ri = 0.30); Mex-SLEDAI (2 vs 1, p < 0.0003, rs = 0.79, ri = 0.31); and LACC (1 vs 1, p = 0.007, rs = 0.65, ri = 0.21). Used to detect active SLE, the retrospective SLEDAI had a sensitivity of 0.68 and a specificity of 0.86; corresponding values for the Mex-SLEDAI were 0.72 and 0.91, and for the LACC, 0.77 and 0.76. Retrospective disease activity indices tended to provide lower scores than prospective evaluations. They often missed patients with mildly active disease, but when positive they were good predictors of disease activity.

The Danish Neuro-Oncology Registry: establishment, completeness and validity.

PubMed

Hansen, Steinbjørn; Nielsen, Jan; Laursen, René J; Rasmussen, Birthe Krogh; Nørgård, Bente Mertz; Gradel, Kim Oren; Guldberg, Rikke

2016-08-30

The Danish Neuro-Oncology Registry (DNOR) is a nationwide clinical cancer database that has prospectively registered data on patients with gliomas since January 2009. The purpose of this study was to describe the establishment of the DNOR and further to evaluate the database completeness of patient registration and validity of data. The completeness of the number of patients registered in the database was evaluated in the study period from January 2009 through December 2014 by comparing cases reported to the DNOR with the Danish National Patient Registry and the Danish Pathology Registry. The data validity of important clinical variables was evaluated by a random sample of 100 patients from the DNOR using the medical records as reference. A total of 2241 patients were registered in the DNOR by December 2014 with an overall patient completeness of 92 %, which increased during the study period (from 78 % in 2009 to 96 % in 2014). Medical records were available for all patients in the validity analyses. Most variables showed a high agreement proportion (56-100 %), with a fair to good chance-corrected agreement (k = 0.43-1.0). The completeness of patient registration was very high (92 %) and the validity of the most important patient data was good. The DNOR is a newly established national database, which is a reliable source for future scientific studies and clinical quality assessments among patients with gliomas.

[Validity and reliability of the screening questionnaire for geriatric depression used in the Mexican Health and Age Study].

PubMed

Aguilar-Navarro, Sara Gloria; Fuentes-Cantú, Alejandro; Avila-Funes, José Alberto; García-Mayo, Emilio José

2007-01-01

To assess the validity and reliability of a geriatric depression questionnaire used in the Mexican Health and Age Study (MHAS). The study was conducted at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) clinic from May 2005 to March 2006. This depression screening nine-item questionnaire was validated using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) (fourth revised version) and Yesavage's 15-item Geriatric Depression Scale (GDS-15) criteria. The instrument belongs to the MHAS, a prospective panel study of health and aging in Mexico. A total of 199 subjects 65 years of age and older participated in the validation process (median age= 79.5 years). MHAS questionnaire result was significantly correlated to the clinical depression diagnosis (p<0.001) and to the GDS-15 score (p<0.001). Internal consistency was adequate (alpha coefficient: 0.74). The cutoff point > or = 5/9 points yielded an 80.7% and 68.7% sensitivity and specificity respectively. The fidelity for the test retest was excellent (intra-class correlation coefficient= 0.933). Finally, the Bland and Altman agreement points indicated a difference 0.22 percent points between test retest. The MHAS questionnaire is valid and trustworthy, and allows screening in the research field for the presence of depression in the elderly.

Diagnostic support for selected neuromuscular diseases using answer-pattern recognition and data mining techniques: a proof of concept multicenter prospective trial.

PubMed

Grigull, Lorenz; Lechner, Werner; Petri, Susanne; Kollewe, Katja; Dengler, Reinhard; Mehmecke, Sandra; Schumacher, Ulrike; Lücke, Thomas; Schneider-Gold, Christiane; Köhler, Cornelia; Güttsches, Anne-Katrin; Kortum, Xiaowei; Klawonn, Frank

2016-03-08

Diagnosis of neuromuscular diseases in primary care is often challenging. Rare diseases such as Pompe disease are easily overlooked by the general practitioner. We therefore aimed to develop a diagnostic support tool using patient-oriented questions and combined data mining algorithms recognizing answer patterns in individuals with selected neuromuscular diseases. A multicenter prospective study for the proof of concept was conducted thereafter. First, 16 interviews with patients were conducted focusing on their pre-diagnostic observations and experiences. From these interviews, we developed a questionnaire with 46 items. Then, patients with diagnosed neuromuscular diseases as well as patients without such a disease answered the questionnaire to establish a database for data mining. For proof of concept, initially only six diagnoses were chosen (myotonic dystrophy and myotonia (MdMy), Pompe disease (MP), amyotrophic lateral sclerosis (ALS), polyneuropathy (PNP), spinal muscular atrophy (SMA), other neuromuscular diseases, and no neuromuscular disease (NND). A prospective study was performed to validate the automated malleable system, which included six different classification methods combined in a fusion algorithm proposing a final diagnosis. Finally, new diagnoses were incorporated into the system. In total, questionnaires from 210 individuals were used to train the system. 89.5 % correct diagnoses were achieved during cross-validation. The sensitivity of the system was 93-97 % for individuals with MP, with MdMy and without neuromuscular diseases, but only 69 % in SMA and 81 % in ALS patients. In the prospective trial, 57/64 (89 %) diagnoses were predicted correctly by the computerized system. All questions, or rather all answers, increased the diagnostic accuracy of the system, with the best results reached by the fusion of different classifier methods. Receiver operating curve (ROC) and p-value analyses confirmed the results. A questionnaire-based diagnostic support tool using data mining methods exhibited good results in predicting selected neuromuscular diseases. Due to the variety of neuromuscular diseases, additional studies are required to measure beneficial effects in the clinical setting.

A new model of wheezing severity in young children using the validated ISAAC wheezing module: A latent variable approach with validation in independent cohorts.

PubMed

Brunwasser, Steven M; Gebretsadik, Tebeb; Gold, Diane R; Turi, Kedir N; Stone, Cosby A; Datta, Soma; Gern, James E; Hartert, Tina V

2018-01-01

The International Study of Asthma and Allergies in Children (ISAAC) Wheezing Module is commonly used to characterize pediatric asthma in epidemiological studies, including nearly all airway cohorts participating in the Environmental Influences on Child Health Outcomes (ECHO) consortium. However, there is no consensus model for operationalizing wheezing severity with this instrument in explanatory research studies. Severity is typically measured using coarsely-defined categorical variables, reducing power and potentially underestimating etiological associations. More precise measurement approaches could improve testing of etiological theories of wheezing illness. We evaluated a continuous latent variable model of pediatric wheezing severity based on four ISAAC Wheezing Module items. Analyses included subgroups of children from three independent cohorts whose parents reported past wheezing: infants ages 0-2 in the INSPIRE birth cohort study (Cohort 1; n = 657), 6-7-year-old North American children from Phase One of the ISAAC study (Cohort 2; n = 2,765), and 5-6-year-old children in the EHAAS birth cohort study (Cohort 3; n = 102). Models were estimated using structural equation modeling. In all cohorts, covariance patterns implied by the latent variable model were consistent with the observed data, as indicated by non-significant χ2 goodness of fit tests (no evidence of model misspecification). Cohort 1 analyses showed that the latent factor structure was stable across time points and child sexes. In both cohorts 1 and 3, the latent wheezing severity variable was prospectively associated with wheeze-related clinical outcomes, including physician asthma diagnosis, acute corticosteroid use, and wheeze-related outpatient medical visits when adjusting for confounders. We developed an easily applicable continuous latent variable model of pediatric wheezing severity based on items from the well-validated ISAAC Wheezing Module. This model prospectively associates with asthma morbidity, as demonstrated in two ECHO birth cohort studies, and provides a more statistically powerful method of testing etiologic hypotheses of childhood wheezing illness and asthma.

Validation of a screening tool for attention and executive functions (EpiTrack Junior) in children and adolescents with absence epilepsy.

PubMed

Kadish, Navah Ester; Baumann, Matthias; Pietz, Joachim; Schubert-Bast, Susanne; Reuner, Gitta

2013-10-01

Our prospective study aimed at the validation of EpiTrack Junior, a neuropsychological screening tool for attention and executive functions in children with epilepsy. Twenty-two children with absence epilepsy aged 8-17 years underwent comprehensive neuropsychological evaluation including EpiTrack Junior and measures of intelligence, verbal and nonverbal memory, word fluency and visuoconstructive organization. Concurrent and discriminant validity of EpiTrack Junior subtests and total score as well as sensitivity and specificity of the total score were analyzed. EpiTrack Junior total score was impaired in 59% of participants. Concurrent validity was demonstrated in 4/6 subtests and for the total score. Discriminant validity was shown with respect to verbal and nonverbal long-term memory. Sensitivity was higher than specificity and highest for the "working memory index". EpiTrack Junior is recommended as a sensitive and time-efficient screening tool for attention and executive functions in children with epilepsy. Impaired results should be followed up with detailed evaluation including information from the parents and school as well as counseling where indicated. © 2013.

Sino-Nasal Outcome Test-22: Translation, Cross-cultural Adaptation, and Validation in Hebrew-Speaking Patients.

PubMed

Shapira Galitz, Yael; Halperin, Doron; Bavnik, Yosef; Warman, Meir

2016-05-01

To perform the translation, cross-cultural adaptation, and validation of the Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire to the Hebrew language. A single-center prospective cross-sectional study. Seventy-three chronic rhinosinusitis (CRS) patients and 73 patients without sinonasal disease filled the Hebrew version of the SNOT-22 questionnaire. Fifty-one CRS patients underwent endoscopic sinus surgery, out of which 28 filled a postoperative questionnaire. Seventy-three healthy volunteers without sinonasal disease also answered the questionnaire. Internal consistency, test-retest reproducibility, validity, and responsiveness of the questionnaire were evaluated. Questionnaire reliability was excellent, with a high internal consistency (Cronbach's alpha coefficient, 0.91-0.936) and test-retest reproducibility (Spearman's coefficient, 0.962). Mean scores for the preoperative, postoperative, and control groups were 50.44, 29.64, and 13.15, respectively (P < .0001 for CRS vs controls, P < .001 for preoperative vs postoperative), showing validity and responsiveness of the questionnaire. The Hebrew version of SNOT-22 questionnaire is a valid outcome measure for patients with CRS with or without nasal polyps. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

Clinical Translation and Validation of a Predictive Biomarker for Patritumab, an Anti-human Epidermal Growth Factor Receptor 3 (HER3) Monoclonal Antibody, in Patients With Advanced Non-small Cell Lung Cancer

PubMed Central

Mendell, Jeanne; Freeman, Daniel J.; Feng, Wenqin; Hettmann, Thore; Schneider, Matthias; Blum, Sabine; Ruhe, Jens; Bange, Johannes; Nakamaru, Kenji; Chen, Shuquan; Tsuchihashi, Zenta; von Pawel, Joachim; Copigneaux, Catherine; Beckman, Robert A.

2015-01-01

Background During early clinical development, prospective identification of a predictive biomarker and validation of an assay method may not always be feasible. Dichotomizing a continuous biomarker measure to classify responders also leads to challenges. We present a case study of a prospective–retrospective approach for a continuous biomarker identified after patient enrollment but defined prospectively before the unblinding of data. An analysis of the strengths and weaknesses of this approach and the challenges encountered in its practical application are also provided. Methods HERALD (NCT02134015) was a double-blind, phase 2 study in patients with non-small cell lung cancer (NSCLC) randomized to erlotinib with placebo or with high or low doses of patritumab, a monoclonal antibody targeted against human epidermal growth factor receptor 3 (HER3). While the primary objective was to assess safety and progression-free survival (PFS), a secondary objective was to determine a single predictive biomarker hypothesis to identify subjects most likely to benefit from the addition of patritumab. Although not identified as the primary biomarker in the study protocol, on the basis of preclinical results from 2 independent laboratories, expression levels of the HER3 ligand heregulin (HRG) were prospectively declared the predictive biomarker before data unblinding but after subject enrollment. An assay to measure HRG mRNA was developed and validated. Other biomarkers, such as epidermal growth factor receptor (EGFR) mutation status, were also evaluated in an exploratory fashion. The cutoff value for high vs. low HRG mRNA levels was set at the median delta threshold cycle. A maximum likelihood analysis was performed to evaluate the provisional cutoff. The relationship of HRG values to PFS hazard ratios (HRs) was assessed as a measure of internal validation. Additional NSCLC samples were analyzed to characterize HRG mRNA distribution. Results The subgroup of patients with high HRG mRNA levels (“HRG-high”) demonstrated clinical benefit from patritumab treatment with HRs of 0.37 (P = 0.0283) and 0.29 (P = 0.0027) in the high- and low-dose patritumab arms, respectively. However, only 102 of the 215 randomized patients (47.4%) had sufficient tumor samples for HRG mRNA measurement. Maximum likelihood analysis showed that the provisional cutoff was within the optimal range. In the placebo arm, the HRG-high subgroup demonstrated worse prognosis compared with HRG-low. A continuous relationship was observed between increased HRG mRNA levels and lower HR. Additional NSCLC samples (N = 300) demonstrated a similar unimodal distribution to that observed in this study, suggesting that the defined cutoff may be applicable to future NSCLC studies. Conclusions The prospective–retrospective approach was successful in clinically validating a probable predictive biomarker. Post hoc in vitro studies and statistical analyses permitted further testing of the underlying assumptions. However, limitations of this analysis include the incomplete collection of adequate tumor tissue and a lack of stratification. In a phase 3 study, findings are being confirmed, and the HRG cutoff value is being further refined. ClinicalTrials.gov Number NCT02134015. PMID:26137564

[Prospective multi-institutional analysis according to the "Japanese guidelines for prevention of perioperative infections in urological field"].

PubMed

Wada, Koichiro; Uehara, Shinya; Kira, Shinichiro; Matsumoto, Masahiro; Sho, Takehiko; Kurimura, Yuichiro; Hashimoto, Jiro; Uehara, Teruhisa; Yamane, Takashi; Kanamaru, Sojun; Togo, Yoshikazu; Taoka, Rikiya; Takahashi, Akira; Yamada, Yusuke; Yokomizo, Akira; Yasuda, Mitsuru; Tanaka, Kazushi; Hamasuna, Ryoichi; Takahashi, Satoshi; Hayami, Hiroshi; Watanabe, Toyohiko; Monden, Koichi; Kiyota, Hiroshi; Deguchi, Takashi; Naito, Seiji; Tsukamoto, Taiji; Arakawa, Soichi; Fujisawa, Masato; Yamamoto, Shingo; Kumon, Hiromi; Matsumoto, Tetsuro

2013-05-01

The "Japanese guidelines for prevention of perioperative infections in urological field" was edited by the Japanese Urological Association in 2007. They are the first Japanese guidelines for antimicrobial prophylaxis specifically to prevent perioperative infections in the urological field. We report here the results of a multicenter prospective study conducted to examine the validity and usefulness of these guidelines. The subjects were 513 patients who had undergone urological surgeries between July and September 2008 at 10 nationwide university institutions in the Japanese Society of UTI Cooperative Study Group. These surgeries were transurethral resection of bladder (TURBT), transurethral resection of prostate (TURP), adrenalectomy, nephrectomy, nephroureterectomy, radical prostatectomy and total cystectomy. Analysis was performed on patient information, surgical procedures, types and durations of administration of prophylactic antibiotic agents, and the presence of surgical site infections (SSI) and remote infections (RI). Of 513 patients, 387 (75.4%) were administered prophylactic antibiotic agents according to the guidelines. In these patients, the incidences of SSI and RI were 5.9% and 4.1%, respectively. Multivariate analysis showed that significant factors for SSI were the surgical risk (according to the ASA physical status classification system), diabetes, and operation time, and that the only significant factor for RI was the operation time. More large-scale study and evidences are necessary in order to demonstrate the validity and usefulness of these guidelines.

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.

Leadership, mental health, and organizational efficacy in health care organizations. Psychosocial predictors of healthy organizational development based on prospective data from four different organizations.

PubMed

Arnetz, Bengt; Blomkvist, Vanja

2007-01-01

Only a few studies of psychosocial determinants of employee health and organizational development have been prospective, involving more than one organization and applying standardized assessment tools. This limits the ability of providing evidence-based guidance as how to carry out healthy organizational transformations. A total of 6,000 employees responded twice to a validated psychosocial-leadership questionnaire within a 2-year period. The assessment focused on changes over time in the three outcome measures - mental health, efficacy, and leadership, determined to be important indicators of a healthy organization. Changes within and between organization were assessed statistically using regular t tests and general linear modeling. There were major differences between organizations in psychosocial measures, both at the baseline and over time. At the organizational level, changes between study periods in management performance feedback, participatory management, and work tempo were the most consistent predictors of improvements over time in the three outcome measures. Performance feedback and participatory management might be two common predictors of healthy workplaces. Some of the psychosocial determinants of healthy organizations suggested in previous research might not be universally valid. It is suggested that future research should to a larger degree make use of multiple departments and organizations in studies of psychosocial determinants of healthy organizations. Copyright 2007 S. Karger AG, Basel.

Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis.

PubMed

Dougados, Maxime; Jousse-Joulin, Sandrine; Mistretta, Frederic; d'Agostino, Maria-Antonietta; Backhaus, Marina; Bentin, Jacques; Chalès, Gérard; Chary-Valckenaere, Isabelle; Conaghan, Philip; Etchepare, Fabien; Gaudin, Philippe; Grassi, Walter; van der Heijde, Désirée; Sellam, Jérémie; Naredo, Esperanza; Szkudlarek, Marcin; Wakefield, Richard; Saraux, Alain

2010-05-01

To evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter. To study selected global scoring systems, for the clinical, B mode and power Doppler techniques, the following joints were evaluated: 28 joints (28-joint Disease Activity Score (DAS28)), 20 joints (metacarpophalangeals (MCPs) + metatarsophalangeals (MTPs)) and 38 joints (28 joints + MTPs) using either a binary (yes/no) or a 0-3 grade. The study was a prospective, 4-month duration follow-up of 76 patients with RA requiring anti-tumour necrosis factor (TNF) therapy (complete follow-up data: 66 patients). Intraobserver reliability was evaluated using the intraclass correlation coefficient (ICC), construct validity was evaluated using the Cronbach alpha test and external validity was evaluated using level of correlation between scoring system and C reactive protein (CRP). Sensitivity to change was evaluated using the standardised response mean. Discriminating capacity was evaluated using the standardised mean differences in patients considered by the doctor as significantly improved or not at the end of the study. Different clinimetric properties of various US scoring systems were at least as good as the clinical scores with, for example, intraobserver reliability ranging from 0.61 to 0.97 versus from 0.53 to 0.82, construct validity ranging from 0.76 to 0.89 versus from 0.76 to 0.88, correlation with CRP ranging from 0.28 to 0.34 versus from 0.28 to 0.35 and sensitivity to change ranging from 0.60 to 1.21 versus from 0.96 to 1.36 for US versus clinical scoring systems, respectively. This study suggests that US evaluation of synovitis is an outcome measure at least as relevant as physical examination. Further studies are required in order to achieve optimal US scoring systems for monitoring patients with RA in clinical trials and in clinical practice.

Validation and Cultural Adaptation of the Arabic Version of the Eating Assessment Tool (EAT-10).

PubMed

Farahat, Mohamed; Mesallam, Tamer A

2015-01-01

The Eating Assessment Tool (EAT-10) is a 10-item self-administered questionnaire. It is a noninvasive tool to measure patients' perception of their swallowing problems. The purposes of the present study were to develop an Arabic version of the EAT-10 and to evaluate its validity, consistency, and reliability in the Arabic-speaking population with oropharyngeal dysphagia. This was a prospective study carried out at the Communication and Swallowing Disorders Unit, King Saud University, Riyadh, Saudi Arabia. The Arabic EAT-10 was administered to 138 patients with oropharyngeal dysphagia and 83 control subjects. Internal consistency and test-retest reliability were evaluated. Content and clinical validity were studied, and the EAT-10 results were compared across patients and control groups. The Arabic EAT-10 showed excellent internal consistency (Cronbach's α = 0.92). Also, good test-retest reliability was found for the total scores of the Arabic EAT-10 (intraclass correlation = 0.73). There was a significant difference in Arabic EAT-10 scores between the oropharyngeal dysphagia group and the control group (p < 0.001). This study demonstrated that the Arabic EAT-10 is a valid tool that can be used for screening of dysphagia-related problems in an Arabic-speaking population. © 2016 S. Karger AG, Basel.

Validity of the International Physical Activity Questionnaire and the Singapore Prospective Study Program physical activity questionnaire in a multiethnic urban Asian population.

PubMed

Nang, Ei Ei Khaing; Gitau Ngunjiri, Susan Ayuko; Wu, Yi; Salim, Agus; Tai, E Shyong; Lee, Jeannette; Van Dam, Rob M

2011-10-13

Physical activity patterns of a population remain mostly assessed by the questionnaires. However, few physical activity questionnaires have been validated in Asian populations. We previously utilized a combination of different questionnaires to assess leisure time, transportation, occupational and household physical activity in the Singapore Prospective Study Program (SP2). The International Physical Activity Questionnaire (IPAQ) has been developed for a similar purpose. In this study, we compared estimates from these two questionnaires with an objective measure of physical activity in a multi-ethnic Asian population. Physical activity was measured in 152 Chinese, Malay and Asian Indian adults using an accelerometer over five consecutive days, including a weekend. Participants completed both the physical activity questionnaire in SP2 (SP2PAQ) and IPAQ long form. 43 subjects underwent a second set of measurements on average 6 months later to assess reproducibility of the questionnaires and the accelerometer measurements. Spearman correlations were used to evaluate validity and reproducibility and correlations for validity were corrected for within-person variation of accelerometer measurements. Agreement between the questionnaires and the accelerometer measurements was also evaluated using Bland Altman plots. The corrected correlation with accelerometer estimates of energy expenditure from physical activity was better for the SP2PAQ (vigorous activity: r = 0.73; moderate activity: r = 0.27) than for the IPAQ (vigorous activity: r = 0.31; moderate activity: r = 0.15). For moderate activity, the corrected correlation between SP2PAQ and the accelerometer was higher for Chinese (r = 0.38) and Malays (r = 0.57) than for Indians (r = -0.09). Both questionnaires overestimated energy expenditure from physical activity to a greater extent at higher levels of physical activity than at lower levels of physical activity. The reproducibility for moderate activity (accelerometer: r = 0.68; IPAQ: r = 0.58; SP2PAQ: r = 0.55) and vigorous activity (accelerometer: 0.52; IPAQ: r = 0.38; SP2PAQ: r = 0.75) was moderate to high for all instruments. The agreement between IPAQ and accelerometer measurements of energy expenditure from physical activity was poor in our Asian study population. The SP2PAQ showed good validity and reproducibility for vigorous activity, but performed less well for moderate activity particularly in Indians. Further effort is needed to develop questionnaires that better capture moderate activity in Asian populations.

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

PubMed Central

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

2016-01-01

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

Sleep-Wake Evaluation from Whole-Night Non-Contact Audio Recordings of Breathing Sounds

PubMed Central

Dafna, Eliran; Tarasiuk, Ariel; Zigel, Yaniv

2015-01-01

Study Objectives To develop and validate a novel non-contact system for whole-night sleep evaluation using breathing sounds analysis (BSA). Design Whole-night breathing sounds (using ambient microphone) and polysomnography (PSG) were simultaneously collected at a sleep laboratory (mean recording time 7.1 hours). A set of acoustic features quantifying breathing pattern were developed to distinguish between sleep and wake epochs (30 sec segments). Epochs (n = 59,108 design study and n = 68,560 validation study) were classified using AdaBoost classifier and validated epoch-by-epoch for sensitivity, specificity, positive and negative predictive values, accuracy, and Cohen's kappa. Sleep quality parameters were calculated based on the sleep/wake classifications and compared with PSG for validity. Setting University affiliated sleep-wake disorder center and biomedical signal processing laboratory. Patients One hundred and fifty patients (age 54.0±14.8 years, BMI 31.6±5.5 kg/m2, m/f 97/53) referred for PSG were prospectively and consecutively recruited. The system was trained (design study) on 80 subjects; validation study was blindly performed on the additional 70 subjects. Measurements and Results Epoch-by-epoch accuracy rate for the validation study was 83.3% with sensitivity of 92.2% (sleep as sleep), specificity of 56.6% (awake as awake), and Cohen's kappa of 0.508. Comparing sleep quality parameters of BSA and PSG demonstrate average error of sleep latency, total sleep time, wake after sleep onset, and sleep efficiency of 16.6 min, 35.8 min, and 29.6 min, and 8%, respectively. Conclusions This study provides evidence that sleep-wake activity and sleep quality parameters can be reliably estimated solely using breathing sound analysis. This study highlights the potential of this innovative approach to measure sleep in research and clinical circumstances. PMID:25710495

Quality assessment of decision-making in colorectal cancer multidisciplinary meetings.

PubMed

Seretis, Charalampos; Mankotia, Rajnish; Goonetilleke, Kolitha; Rawstorne, Edward

2014-01-01

The quality of decision-making in the colorectal multidisciplinary team (MDT) meetings can significantly affect the quality of care delivered to patients with colorectal cancer. We performed a prospective study to assess the quality of the MDT meetings in a specialized colorectal unit using an externally observational validated tool. An externally validated observational tool, the Colorectal Multidisciplinary Team Metric for Observation of Decision-Making (cMDT-MODe), was used to assess the quality of clinical decision-making in 64 cases. Although case history information presented by the responsible surgeon was rated high (4.4/5), the quality of radiological and histopathological information regarding each patient's case which was available at the time was less adequate, scoring 3.9/5 and 3.8/5, respectively. Moreover, the precise knowledge of patients' personal views and circumstances was a field requiring further improvement. In a general overview however, the quality and extent of the available information enabled the MDT to provide a clear recommendation regarding the patients' treatment plans in 87.5% of the cases. The cMDT-MODe tool can be used to prospectively audit the quality of clinical decision-making in the colorectal MDT meetings and highlight the fields of potential improvement.

Binding mode prediction and MD/MMPBSA-based free energy ranking for agonists of REV-ERBα/NCoR.

PubMed

Westermaier, Yvonne; Ruiz-Carmona, Sergio; Theret, Isabelle; Perron-Sierra, Françoise; Poissonnet, Guillaume; Dacquet, Catherine; Boutin, Jean A; Ducrot, Pierre; Barril, Xavier

2017-08-01

The knowledge of the free energy of binding of small molecules to a macromolecular target is crucial in drug design as is the ability to predict the functional consequences of binding. We highlight how a molecular dynamics (MD)-based approach can be used to predict the free energy of small molecules, and to provide priorities for the synthesis and the validation via in vitro tests. Here, we study the dynamics and energetics of the nuclear receptor REV-ERBα with its co-repressor NCoR and 35 novel agonists. Our in silico approach combines molecular docking, molecular dynamics (MD), solvent-accessible surface area (SASA) and molecular mechanics poisson boltzmann surface area (MMPBSA) calculations. While docking yielded initial hints on the binding modes, their stability was assessed by MD. The SASA calculations revealed that the presence of the ligand led to a higher exposure of hydrophobic REV-ERB residues for NCoR recruitment. MMPBSA was very successful in ranking ligands by potency in a retrospective and prospective manner. Particularly, the prospective MMPBSA ranking-based validations for four compounds, three predicted to be active and one weakly active, were confirmed experimentally.

Prognostic value of quantitative sensory testing in low back pain: a systematic review of the literature

PubMed Central

Marcuzzi, Anna; Dean, Catherine M; Wrigley, Paul J; Chakiath, Rosemary J; Hush, Julia M

2016-01-01

Quantitative sensory testing (QST) measures have recently been shown to predict outcomes in various musculoskeletal and pain conditions. The aim of this systematic review was to summarize the emerging body of evidence investigating the prognostic value of QST measures in people with low back pain (LBP). The protocol for this review was prospectively registered on the International Prospective Register of Systematic Reviews. An electronic search of six databases was conducted from inception to October 2015. Experts in the field were contacted to retrieve additional unpublished data. Studies were included if they were prospective longitudinal in design, assessed at least one QST measure in people with LBP, assessed LBP status at follow-up, and reported the association of QST data with LBP status at follow-up. Statistical pooling of results was not possible due to heterogeneity between studies. Of 6,408 references screened after duplicates removed, three studies were finally included. None of them reported a significant association between the QST measures assessed and the LBP outcome. Three areas at high risk of bias were identified which potentially compromise the validity of these results. Due to the paucity of available studies and the methodological shortcomings identified, it remains unknown whether QST measures are predictive of outcome in LBP. PMID:27660486

Prognostic value of quantitative sensory testing in low back pain: a systematic review of the literature.

PubMed

Marcuzzi, Anna; Dean, Catherine M; Wrigley, Paul J; Chakiath, Rosemary J; Hush, Julia M

2016-01-01

Quantitative sensory testing (QST) measures have recently been shown to predict outcomes in various musculoskeletal and pain conditions. The aim of this systematic review was to summarize the emerging body of evidence investigating the prognostic value of QST measures in people with low back pain (LBP). The protocol for this review was prospectively registered on the International Prospective Register of Systematic Reviews. An electronic search of six databases was conducted from inception to October 2015. Experts in the field were contacted to retrieve additional unpublished data. Studies were included if they were prospective longitudinal in design, assessed at least one QST measure in people with LBP, assessed LBP status at follow-up, and reported the association of QST data with LBP status at follow-up. Statistical pooling of results was not possible due to heterogeneity between studies. Of 6,408 references screened after duplicates removed, three studies were finally included. None of them reported a significant association between the QST measures assessed and the LBP outcome. Three areas at high risk of bias were identified which potentially compromise the validity of these results. Due to the paucity of available studies and the methodological shortcomings identified, it remains unknown whether QST measures are predictive of outcome in LBP.

A Resource of Quantitative Functional Annotation for Homo sapiens Genes.

PubMed

Taşan, Murat; Drabkin, Harold J; Beaver, John E; Chua, Hon Nian; Dunham, Julie; Tian, Weidong; Blake, Judith A; Roth, Frederick P

2012-02-01

The body of human genomic and proteomic evidence continues to grow at ever-increasing rates, while annotation efforts struggle to keep pace. A surprisingly small fraction of human genes have clear, documented associations with specific functions, and new functions continue to be found for characterized genes. Here we assembled an integrated collection of diverse genomic and proteomic data for 21,341 human genes and make quantitative associations of each to 4333 Gene Ontology terms. We combined guilt-by-profiling and guilt-by-association approaches to exploit features unique to the data types. Performance was evaluated by cross-validation, prospective validation, and by manual evaluation with the biological literature. Functional-linkage networks were also constructed, and their utility was demonstrated by identifying candidate genes related to a glioma FLN using a seed network from genome-wide association studies. Our annotations are presented-alongside existing validated annotations-in a publicly accessible and searchable web interface.

Validation of Predictors of Fall Events in Hospitalized Patients With Cancer.

PubMed

Weed-Pfaff, Samantha H; Nutter, Benjamin; Bena, James F; Forney, Jennifer; Field, Rosemary; Szoka, Lynn; Karius, Diana; Akins, Patti; Colvin, Christina M; Albert, Nancy M

2016-10-01

A seven-item cancer-specific fall risk tool (Cleveland Clinic Capone-Albert [CC-CA] Fall Risk Score) was shown to have a strong concordance index for predicting falls; however, validation of the model is needed. The aims of this study were to validate that the CC-CA Fall Risk Score, made up of six factors, predicts falls in patients with cancer and to determine if the CC-CA Fall Risk Score performs better than the Morse Fall Tool. Using a prospective, comparative methodology, data were collected from electronic health records of patients hospitalized for cancer care in four hospitals. Risk factors from each tool were recorded, when applicable. Multivariable models were created to predict the probability of a fall. A concordance index for each fall tool was calculated. The CC-CA Fall Risk Score provided higher discrimination than the Morse Fall Tool in predicting fall events in patients hospitalized for cancer management.

Validation of an organizational communication climate assessment toolkit.

PubMed

Wynia, Matthew K; Johnson, Megan; McCoy, Thomas P; Griffin, Leah Passmore; Osborn, Chandra Y

2010-01-01

Effective communication is critical to providing quality health care and can be affected by a number of modifiable organizational factors. The authors performed a prospective multisite validation study of an organizational communication climate assessment tool in 13 geographically and ethnically diverse health care organizations. Communication climate was measured across 9 discrete domains. Patient and staff surveys with matched items in each domain were developed using a national consensus process, which then underwent psychometric field testing and assessment of domain coherence. The authors found meaningful within-site and between-site performance score variability in all domains. In multivariable models, most communication domains were significant predictors of patient-reported quality of care and trust. The authors conclude that these assessment tools provide a valid empirical assessment of organizational communication climate in 9 domains. Assessment results may be useful to track organizational performance, to benchmark, and to inform tailored quality improvement interventions.

Preclinical Validation of Novel Fluorescently Labeled Compounds to Treat Neurodegenerative Hearing Loss

DTIC Science & Technology

2016-10-01

evaluated using 209, 639, and 1269 magnification. For repre- sentative documentation of the morphology of each specimen, the photographs were taken from the...Holmes SJ, Kaplan SL, Jubelirer DP, Stechenberg BW, Hirsh SK (1984) Prospective evaluation of hearing impairment as a sequela of acute bacterial...enters the field of gene therapy and human studies commence, the question arises whether audiograms e the current gold standard for the evaluation of

The validity and reliability of the Arabic version of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU): A prospective cohort study.

PubMed

Selim, Abeer; Kandeel, Nahed; Elokl, Mohamed; Khater, Mohamed Shawky; Saleh, Ashraf Nabil; Bustami, Rami; Ely, E Wesley

2018-04-01

Accurate diagnosis for Arabic speaking critically ill patients suffering from delirium is limited by the need for a valid/reliable translation of a standardized delirium instrument such as the Confusion Assessment Method for the ICU (CAM-ICU). To determine the validity and reliability of the Arabic version of the CAM-ICU. A prospective cohort study design was used to conduct the current study. Data collection took place in Geriatric, Emergency and Surgical intensive care units. Fifty-eight adult patients met the inclusion criteria and participated in the study. Among the participants 22(38%) patients were on mechanical ventilation. After translating the CAM-ICU into Arabic language, the Arabic CAM-ICU was administered by two well-trained critical care nurses and compared with reference standard assessments by delirium experts using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM -IV-TR), along with assessment of severity of illness using Sequential Organ Failure Assessment (SOFA). Concurrent validity was assessed by calculating sensitivity, specificity and positive and negative predictive value (PPV and NPV) for the two Arabic CAM-ICU raters, where calculations were based on considering the DSM-IV-TR criterion as the reference standard. The convergent validity of the Arabic CAM-ICU was explored by comparing the Arabic CAM-ICU ratings and the total score of SOFA (severity of illness) and MMSE (cognitive impairment). A total of 58 ICU patients were included, of whom 27 (47%) were diagnosed with delirium during their ICU stay via DSM-IV criteria. Interrater reliability for the Arabic CAM-ICU, overall and for mechanically ventilated patients assessed using Cohen's kappa (κ) were 0.82 and 1, respectively, p < 0.001. The sensitivities (95% CI) for the two critical care nurses when using the Arabic CAM-ICU compared with the reference standard were 81% (60%-93%) and 85% (65%-95%), respectively, whereas specificity (95% CI) was 81%(62%-92%) for both nurses. High sensitivity and specificity measures were also observed across subgroups; 100% for mechanically ventilated patients, 88% (60%-98%) and 79% (49%-94%) for those aged 65 years or older and 82% (56%-95%) and 75% (43%-93%) for those with SOFA scores at or above the median value. The Arabic CAM-ICU appeared to be valid and reliable tool for diagnosing delirium. Future investigations may lead to a better understanding of the prevalence, predictors, and consequences of delirium among critically ill Arabic speaking patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Risk stratification after paracetamol overdose using mechanistic biomarkers: results from two prospective cohort studies.

PubMed

Dear, James W; Clarke, Joanna I; Francis, Ben; Allen, Lowri; Wraight, Jonathan; Shen, Jasmine; Dargan, Paul I; Wood, David; Cooper, Jamie; Thomas, Simon H L; Jorgensen, Andrea L; Pirmohamed, Munir; Park, B Kevin; Antoine, Daniel J

2018-02-01

Paracetamol overdose is common but patient stratification is suboptimal. We investigated the usefulness of new biomarkers that have either enhanced liver specificity (microRNA-122 [miR-122]) or provide mechanistic insights (keratin-18 [K18], high mobility group box-1 [HMGB1], and glutamate dehydrogenase [GLDH]). The use of these biomarkers could help stratify patients for their risk of liver injury at hospital presentation. Using data from two prospective cohort studies, we assessed the potential for biomarkers to stratify patients who overdose with paracetamol. We completed two independent prospective studies: a derivation study (MAPP) in eight UK hospitals and a validation study (BIOPAR) in ten UK hospitals. Patients in both cohorts were adults (≥18 years in England, ≥16 years in Scotland), were diagnosed with paracetamol overdose, and gave written informed consent. Patients who needed intravenous acetylcysteine treatment for paracetamol overdose had circulating biomarkers measured at hospital presentation. The primary endpoint was acute liver injury indicating need for continued acetylcysteine treatment beyond the standard course (alanine aminotransferase [ALT] activity >100 U/L). Receiver operating characteristic (ROC) curves, category-free net reclassification index (cfNRI), and integrated discrimination index (IDI) were applied to assess endpoint prediction. Between June 2, 2010, and May 29, 2014, 1187 patients who required acetylcysteine treatment for paracetamol overdose were recruited (985 in the MAPP cohort; 202 in the BIOPAR cohort). In the derivation and validation cohorts, acute liver injury was predicted at hospital presentation by miR-122 (derivation cohort ROC-area under the curve [AUC] 0·97 [95% CI 0·95-0·98]), HMGB1 (0·95 [0·93-0·98]), and full-length K18 (0·95 [0·92-0·97]). Results were similar in the validation cohort (miR-122 AUC 0·97 [95% CI 0·95-0·99], HMGB1 0·98 [0·96-0·99], and full-length K18 0·93 [0·86-0·99]). A combined model of miR-122, HMGB1, and K18 predicted acute liver injury better than ALT alone (cfNRI 1·95 [95% CI 1·87-2·03], p<0·0001 in the MAPP cohort; 1·54 [1·08-2·00], p<0·0001 in the BIOPAR cohort). Personalised treatment pathways could be developed by use of miR-122, HMGB1, and full-length K18 at hospital presentation for patient stratification. This prospective study supports their use for hepatic safety assessment of new medicines. Edinburgh and Lothians Health Foundation, UK Medical Research Council. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

A home calendar and recall method of last menstrual period for estimating gestational age in rural Bangladesh: a validation study.

PubMed

Gernand, Alison D; Paul, Rina Rani; Ullah, Barkat; Taher, Muhammad A; Witter, Frank R; Wu, Lee; Labrique, Alain B; West, Keith P; Christian, Parul

2016-10-21

The best method of gestational age assessment is by ultrasound in the first trimester; however, this method is impractical in large field trials in rural areas. Our objective was to assess the validity of gestational age estimated from prospectively collected date of last menstrual period (LMP) using crown-rump length (CRL) measured in early pregnancy by ultrasound. As part of a large, cluster-randomized, controlled trial in rural Bangladesh, we collected dates of LMP by recall and as marked on a calendar every 5 weeks in women likely to become pregnant. Among those with a urine-test confirmed pregnancy, a subset with gestational age of <15 weeks (n = 353) were enrolled for ultrasound follow-up to measure CRL. We compared interview-assessed LMP with CRL gestational age estimates and classification of preterm, term, and post-term births. LMP-based gestational age was higher than CRL by a mean (SD) of 2.8 (10.7) days; differences varied by maternal education and preterm birth (P < 0.05). Lin's concordance correlation coefficient was good at ultrasound [0.63 (95 % CI 0.56, 0.69)] and at birth [0.77 (95 % CI 0.73, 0.81)]. Validity of classifying preterm birth was high but post-term was lower, with specificity of 96 and 89 % and sensitivity of 86 and 67 %, respectively. Results were similar by parity. Prospectively collected LMP provided a valid estimate of gestational age and preterm birth in a rural, low-income setting and may be a suitable alternative to ultrasound in programmatic settings and large field trials. ClinicalTrials.gov NCT00860470.

A Prognostic Model for One-year Mortality in Patients Requiring Prolonged Mechanical Ventilation

PubMed Central

Carson, Shannon S.; Garrett, Joanne; Hanson, Laura C.; Lanier, Joyce; Govert, Joe; Brake, Mary C.; Landucci, Dante L.; Cox, Christopher E.; Carey, Timothy S.

2009-01-01

Objective A measure that identifies patients who are at high risk of mortality after prolonged ventilation will help physicians communicate prognosis to patients or surrogate decision-makers. Our objective was to develop and validate a prognostic model for 1-year mortality in patients ventilated for 21 days or more. Design Prospective cohort study. Setting University-based tertiary care hospital Patients 300 consecutive medical, surgical, and trauma patients requiring mechanical ventilation for at least 21 days were prospectively enrolled. Measurements and Main Results Predictive variables were measured on day 21 of ventilation for the first 200 patients and entered into logistic regression models with 1-year and 3-month mortality as outcomes. Final models were validated using data from 100 subsequent patients. One-year mortality was 51% in the development set and 58% in the validation set. Independent predictors of mortality included requirement for vasopressors, hemodialysis, platelet count ≤150 ×109/L, and age ≥50. Areas under the ROC curve for the development model and validation model were 0.82 (se 0.03) and 0.82 (se 0.05) respectively. The model had sensitivity of 0.42 (se 0.12) and specificity of 0.99 (se 0.01) for identifying patients who had ≥90% risk of death at 1 year. Observed mortality was highly consistent with both 3- and 12-month predicted mortality. These four predictive variables can be used in a simple prognostic score that clearly identifies low risk patients (no risk factors, 15% mortality) and high risk patients (3 or 4 risk factors, 97% mortality). Conclusions Simple clinical variables measured on day 21 of mechanical ventilation can identify patients at highest and lowest risk of death from prolonged ventilation. PMID:18552692

Predicting Hemorrhagic Transformation of Acute Ischemic Stroke: Prospective Validation of the HeRS Score.

PubMed

Marsh, Elisabeth B; Llinas, Rafael H; Schneider, Andrea L C; Hillis, Argye E; Lawrence, Erin; Dziedzic, Peter; Gottesman, Rebecca F

2016-01-01

Hemorrhagic transformation (HT) increases the morbidity and mortality of ischemic stroke. Anticoagulation is often indicated in patients with atrial fibrillation, low ejection fraction, or mechanical valves who are hospitalized with acute stroke, but increases the risk of HT. Risk quantification would be useful. Prior studies have investigated risk of systemic hemorrhage in anticoagulated patients, but none looked specifically at HT. In our previously published work, age, infarct volume, and estimated glomerular filtration rate (eGFR) significantly predicted HT. We created the hemorrhage risk stratification (HeRS) score based on regression coefficients in multivariable modeling and now determine its validity in a prospectively followed inpatient cohort.A total of 241 consecutive patients presenting to 2 academic stroke centers with acute ischemic stroke and an indication for anticoagulation over a 2.75-year period were included. Neuroimaging was evaluated for infarct volume and HT. Hemorrhages were classified as symptomatic versus asymptomatic, and by severity. HeRS scores were calculated for each patient and compared to actual hemorrhage status using receiver operating curve analysis.Area under the curve (AUC) comparing predicted odds of hemorrhage (HeRS score) to actual hemorrhage status was 0.701. Serum glucose (P < 0.001), white blood cell count (P < 0.001), and warfarin use prior to admission (P = 0.002) were also associated with HT in the validation cohort. With these variables, AUC improved to 0.854. Anticoagulation did not significantly increase HT; but with higher intensity anticoagulation, hemorrhages were more likely to be symptomatic and more severe.The HeRS score is a valid predictor of HT in patients with ischemic stroke and indication for anticoagulation.

Validation of the clinical dehydration scale for children with acute gastroenteritis.

PubMed

Goldman, Ran D; Friedman, Jeremy N; Parkin, Patricia C

2008-09-01

We previously created a clinical dehydration scale. Our objective was to validate the clinical dehydration scale with a new cohort of patients with acute gastroenteritis who were assessed in a tertiary emergency department in a developed country. A prospective observational study was performed in an emergency department at a large pediatric tertiary center in Canada. Children 1 month to 5 years of age with symptoms of acute gastroenteritis who were assessed in the emergency department were enrolled consecutively during a 4-month period. The main outcome measures were length of stay, proportion of children receiving intravenous fluid rehydration, and proportions of children with abnormal serum pH values or bicarbonate levels. A total of 205 children were enrolled, with a mean age of 22.4 +/- 14.9 months; 103 (50%) were male. The distribution of severity categories was as follows: no dehydration (score of 0), n = 117 (57%); some dehydration (score of 1-4), n = 83 (41%); moderate/severe dehydration (score of 5-8), n = 5 (2%). The 3 dehydration categories were significantly different with respect to the validation hypotheses (length of stay, mean +/- SD: none, 245 +/- 181 minutes; some, 397 +/- 302 minutes; moderate/severe, 501 +/- 389 minutes; treatment with intravenous fluids: none, n =17, 15%; some, n = 41, 49%; moderate/severe, n = 4, 80%; number of vomiting episodes in the 7 days before the emergency department visit: none, 8.4 +/- 7.7 episodes; some, 13 +/- 10.7 episodes; moderate/severe, 30.2 +/- 14.8 episodes). The clinical dehydration scale and the 3 severity categories were valid for a prospectively enrolled cohort of patients who were assessed in our tertiary emergency department. The scoring system was valuable in predicting a longer length of stay and the need for intravenous fluid rehydration for children with symptoms of acute gastroenteritis.

Simulated ventriculostomy training with conventional neuronavigational equipment used clinically in the operating room: prospective validation study.

PubMed

Kirkman, Matthew A; Muirhead, William; Sevdalis, Nick; Nandi, Dipankar

2015-01-01

Simulation is gaining increasing interest as a method of delivering high-quality, time-effective, and safe training to neurosurgical residents. However, most current simulators are purpose-built for simulation, being relatively expensive and inaccessible to many residents. The purpose of this study was to provide the first comprehensive validity assessment of ventriculostomy performance metrics from the Medtronic StealthStation S7 Surgical Navigation System, a neuronavigational tool widely used in the clinical setting, as a training tool for simulated ventriculostomy while concomitantly reporting on stress measures. A prospective study where participants performed 6 simulated ventriculostomy attempts on a model head with StealthStation-coregistered imaging. The performance measures included distance of the ventricular catheter tip to the foramen of Monro and presence of the catheter tip in the ventricle. Data on objective and self-reported stress and workload measures were also collected. The operating rooms of the National Hospital for Neurology and Neurosurgery, Queen Square, London. A total of 31 individuals with varying levels of prior ventriculostomy experience, varying in seniority from medical student to senior resident. Performance at simulated ventriculostomy improved significantly over subsequent attempts, irrespective of previous ventriculostomy experience. Performance improved whether or not the StealthStation display monitor was used for real-time visual feedback, but performance was optimal when it was. Further, performance was inversely correlated with both objective and self-reported measures of stress (traditionally referred to as concurrent validity). Stress and workload measures were well-correlated with each other, and they also correlated with technical performance. These initial data support the use of the StealthStation as a training tool for simulated ventriculostomy, providing a safe environment for repeated practice with immediate feedback. Although the potential implications are profound for neurosurgical education and training, further research following this proof-of-concept study is required on a larger scale for full validation and proof that training translates into improved long-term simulated and patient outcomes. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Construct validity of the ovine model in endoscopic sinus surgery training.

PubMed

Awad, Zaid; Taghi, Ali; Sethukumar, Priya; Tolley, Neil S

2015-03-01

To demonstrate construct validity of the ovine model as a tool for training in endoscopic sinus surgery (ESS). Prospective, cross-sectional evaluation study. Over 18 consecutive months, trainees and experts were evaluated in their ability to perform a range of tasks (based on previous face validation and descriptive studies conducted by the same group) relating to ESS on the sheep-head model. Anonymized randomized video recordings of the above were assessed by two independent and blinded assessors. A validated assessment tool utilizing a five-point Likert scale was employed. Construct validity was calculated by comparing scores across training levels and experts using mean and interquartile range of global and task-specific scores. Subgroup analysis of the intermediate group ascertained previous experience. Nonparametric descriptive statistics were used, and analysis was carried out using SPSS version 21 (IBM, Armonk, NY). Reliability of the assessment tool was confirmed. The model discriminated well between different levels of expertise in global and task-specific scores. A positive correlation was noted between year in training and both global and task-specific scores (P < .001). Experience of the intermediate group was variable, and the number of ESS procedures performed under supervision had the highest impact on performance. This study describes an alternative model for ESS training and assessment. It is also the first to demonstrate construct validity of the sheep-head model for ESS training. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

3D-CAM: Derivation and Validation of a 3-Minute Diagnostic Interview for CAM-defined Delirium

PubMed Central

Marcantonio, Edward R.; Ngo, Long H.; O’Connor, Margaret; Jones, Richard N.; Crane, Paul K.; Metzger, Eran D.; Inouye, Sharon K.

2015-01-01

Background Delirium is common, morbid, and costly, yet remains often unrecognized in most clinical settings. The Confusion Assessment Method (CAM) is the most widely used diagnostic algorithm, and operationalizing its features would represent a substantial advance for clinical care. Objective To derive the 3D-CAM, a new 3-minute diagnostic assessment for CAM-defined delirium, and to validate it against a clinical reference standard. Design Diagnostic test study Setting 4 general medicine units in an academic medical center Participants 201 inpatients aged ≥ 75 years old Measurements We identified 20 items that best operationalized the 4 CAM diagnostic features to create the 3D-CAM. For prospective validation, 3D-CAM assessments were administered by trained research assistants. Independently, clinicians performed an extensive assessment that included patient interviews, family interviews, and review of the medical record. These data were considered by an expert panel to determine the presence or absence of delirium and dementia (reference standard). We compared the 3D-CAM delirium determination to the reference standard in all patients and in subgroups with and without dementia. Results The 201 participants in the prospective validation study had mean age (SD) of 84 (5.5) years, and 27% had dementia. The expert panel identified delirium in 21%. Median administration time for 3D-CAM was 3 minutes (inter-quartile range: 2–5 minutes). The sensitivity [95% CI] of 3D-CAM was 95% [84%, 99%] and the specificity was 94% [90%, 97%]. The 3D-CAM performed well in patients both with dementia (sensitivity=96% [82%, 100%], specificity=86% [67%, 96%]) and without dementia (sensitivity=93% [66%, 100%], specificity=96% [91%,99%]). Limitations Limited to single center, cross-sectional, and medicine patients only Conclusion The 3D-CAM operationalizes the CAM algorithm using a 3-minute structured assessment with high sensitivity and specificity relative to a reference standard and could be an important tool for improving recognition of delirium. PMID:25329203

Prospective validation study of the International Classification of Functioning, Disability and Health score in Crohn's disease and ulcerative colitis.

PubMed

Leong, Rupert W L; Huang, Tony; Ko, Yanna; Jeon, Ari; Chang, Jeff; Kohler, Friedbert; Kariyawasam, Viraj

2014-10-01

Inflammatory bowel diseases (IBD) may result in disability. We aim to validate a novel scoring system for the IBD disability index (IBD-DI), and identify predictors of disability and its correlation with work absenteeism. This prospective IBD ambulatory clinic cohort study measured IBD-DI, Crohn's Disease Activity Index (CDAI) for Crohn's disease (CD) or partial Mayo score (pMayo) for ulcerative colitis (UC), IBDQ quality-of-life, and Work Productivity and Activity Impairment. Negative IBD-DI represented greater disability. Validation tests were performed and predictors and extent of work absenteeism were determined. 166 consecutive subjects were recruited (75 CD, 41 UC, 50 controls). IBD-DI correlated with CDAI (r=-0.77, P<0.001), pMayo (r=-0.82, P<0.001) and IBDQ (r=0.86, P<0.001). IBD-DI differentiated CD, and UC from controls (medians -7, -4, +10; P<0.001) with a score of >3.5 identifying controls with 94% sensitivity and 83% specificity (area-under-curve 0.92). Stable patients had unchanged IBD-DI (P=ns) but not in those who relapsed (P<0.001). Intraclass correlation was 0.89 and Cronbach's alpha of internal consistency was 0.94. Diagnosis age, sex, phenotype, perianal disease, prior surgery, steroid-use and disease duration did not influence the IBD-DI but active use of biological agents significantly reduced disability (P=0.03). 21.6% of IBD patients had moderate-severe disability equating to missing >25% of work hours in the previous week. Multivariate analysis identified that only IBD-DI to be predictive of unemployment status (OR: 0.94; 95% CI: 0.89-0.99). The IBD-DI is a valid tool measuring disability in both CD and UC and correlates with workforce participation. It is a potential useful tool in the assessment of participation restriction and activity limitation. ACTRN12613000903785. Copyright © 2014 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

Full immersion simulation: validation of a distributed simulation environment for technical and non-technical skills training in Urology.

PubMed

Brewin, James; Tang, Jessica; Dasgupta, Prokar; Khan, Muhammad S; Ahmed, Kamran; Bello, Fernando; Kneebone, Roger; Jaye, Peter

2015-07-01

To evaluate the face, content and construct validity of the distributed simulation (DS) environment for technical and non-technical skills training in endourology. To evaluate the educational impact of DS for urology training. DS offers a portable, low-cost simulated operating room environment that can be set up in any open space. A prospective mixed methods design using established validation methodology was conducted in this simulated environment with 10 experienced and 10 trainee urologists. All participants performed a simulated prostate resection in the DS environment. Outcome measures included surveys to evaluate the DS, as well as comparative analyses of experienced and trainee urologist's performance using real-time and 'blinded' video analysis and validated performance metrics. Non-parametric statistical methods were used to compare differences between groups. The DS environment demonstrated face, content and construct validity for both non-technical and technical skills. Kirkpatrick level 1 evidence for the educational impact of the DS environment was shown. Further studies are needed to evaluate the effect of simulated operating room training on real operating room performance. This study has shown the validity of the DS environment for non-technical, as well as technical skills training. DS-based simulation appears to be a valuable addition to traditional classroom-based simulation training. © 2014 The Authors BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.

Prospective, Multicenter Validation Study of Magnetic Resonance Volumetry for Response Assessment After Preoperative Chemoradiation in Rectal Cancer: Can the Results in the Literature be Reproduced?

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

Martens, Milou H., E-mail: mh.martens@hotmail.com; Department of Surgery, Maastricht University Medical Center, Maastricht; GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht

2015-12-01

Purpose: To review the available literature on tumor size/volume measurements on magnetic resonance imaging for response assessment after chemoradiotherapy, and validate these cut-offs in an independent multicenter patient cohort. Methods and Materials: The study included 2 parts. (1) Review of the literature: articles were included that assessed the accuracy of tumor size/volume measurements on magnetic resonance imaging for tumor response assessment. Size/volume cut-offs were extracted; (2) Multicenter validation: extracted cut-offs from the literature were tested in a multicenter cohort (n=146). Accuracies were calculated and compared with reported results from the literature. Results: The review included 14 articles, in which 3more » different measurement methods were assessed: (1) tumor length; (2) 3-dimensonial tumor size; and (3) whole volume. Study outcomes consisted of (1) complete response (ypT0) versus residual tumor; (2) tumor regression grade 1 to 2 versus 3 to 5; and (3) T-downstaging (ypT« less

[Spanish translation and validation of the EMPATHIC-30 questionnaire to measure parental satisfaction in intensive care units].

PubMed

Pilar Orive, Francisco Javier; Basabe Lozano, Jasone; López Zuñiga, Aurora; López Fernández, Yolanda M; Escudero Argaluza, Julene; Latour, Jos M

2017-11-03

Few validated surveys measuring parental satisfaction in the Paediatric Intensive Care Unit (PICU) are available, and none of them in Spanish language. The aim of this study is to translate and validate the questionnaire EMpowerment of PArents in THe Intensive Care (EMPATHIC). This questionnaire measures parental perceptions of paediatric intensive care-related satisfaction items in the Spanish language. A prospective cohort study was carried out using questionnaires completed by relatives of children (range 0-17 years old) admitted into a tertiary PICU. Inclusion criteria were a length of stay more than 24h, and a suitable understanding of Spanish language by parents or guardians. Exclusion criteria were re-admissions and deceased patients. The questionnaire was translated from English to Spanish language using a standardised procedure, after which it was used in a cross-sectional observational study was performed to confirm its validity and consistency. Reliability was estimated using Cronbach's α, and content validity using Spearman's correlation analysis. A total of 150 questionnaires were collected. A Cronbach's α was obtained for domains greater than 0.7, showing a high internal consistency from the questionnaire. Validity was measured by correlating 5 domains with 4 general satisfaction items, documenting an adequate correlation (Rs: 0.41-0.66, P<.05). The Spanish version of EMPHATIC 30 is a feasible, easy, and suitable tool in this specific environment, based on the results. EMPATHIC 30 is able to measure parental satisfaction, and may serve as a valid indicator to measure quality of care in Spanish PICUs. Copyright © 2017. Publicado por Elsevier España, S.L.U.

The IRYSS-COPD appropriateness study: objectives, methodology, and description of the prospective cohort

PubMed Central

2011-01-01

Background Patients with chronic obstructive pulmonary disease (COPD) often experience exacerbations of the disease that require hospitalization. Current guidelines offer little guidance for identifying patients whose clinical situation is appropriate for admission to the hospital, and properly developed and validated severity scores for COPD exacerbations are lacking. To address these important gaps in clinical care, we created the IRYSS-COPD Appropriateness Study. Methods/Design The RAND/UCLA Appropriateness Methodology was used to identify appropriate and inappropriate scenarios for hospital admission for patients experiencing COPD exacerbations. These scenarios were then applied to a prospective cohort of patients attending the emergency departments (ED) of 16 participating hospitals. Information was recorded during the time the patient was evaluated in the ED, at the time a decision was made to admit the patient to the hospital or discharge home, and during follow-up after admission or discharge home. While complete data were generally available at the time of ED admission, data were often missing at the time of decision making. Predefined assumptions were used to impute much of the missing data. Discussion The IRYSS-COPD Appropriateness Study will validate the appropriateness criteria developed by the RAND/UCLA Appropriateness Methodology and thus better delineate the requirements for admission or discharge of patients experiencing exacerbations of COPD. The study will also provide a better understanding of the determinants of outcomes of COPD exacerbations, and evaluate the equity and variability in access and outcomes in these patients. PMID:22115318

Proposed minimal panel of antibodies for cost-effectiveness and accuracy in acute leukemias immunophenotyping: Prospective study at a tertiary care center.

PubMed

Singh, Neha; Pati, Hara Prasad P; Tyagi, Seema; Deka, Roopam; Sharma, Rahul; Saxena, Renu

2016-07-01

Flowcytometry has an essential role in the diagnosis and classification of acute leukemias. However, there exists a great degree of inter-laboratory variability on issues like panel selection, antibody combinations, gating strategies, fluorochromes, and clonal selection. The primary aim of this study was to derive a minimal panel of antibodies and evaluate its diagnostic usefulness in acute leukemias by flowcytometry by using the detailed immune-phenotype of different lineage-specific or non-specific markers. This prospective observational study involved 400 newly diagnosed cases of acute leukemias. Bone marrow aspirate samples were subjected to morphological evaluation, cytogenetics and flow cytometric immunophenotyping. A minimal panel of eight antibodies comprising of CD45/CD34/CD19/MPO/cytoCD3/CD64/CD117/CD79a was derived by applying different permutations and combinations with a diagnostic yield of 97.5%. The minimal panel was further validated by testing in an independent cohort of patients with similar demographic characteristics, where it showed a high diagnostic yield of 98% in comparison with the screening panels proposed by other recently published studies. It may be concluded that the diagnostic performance of the eight antibody panel is better than most other panels used across the different laboratories in terms of yield, number of antibodies used and the scientific approach used to derive and validate the results and so henceforth may be applied in any setting with limited resources for better diagnostic accuracy.

Validity of a family-centered approach for assessing infants' social-emotional wellbeing and their developmental context: a prospective cohort study.

PubMed

Hielkema, Margriet; De Winter, Andrea F; Reijneveld, Sijmen A

2017-06-15

Family-centered care seems promising in preventive pediatrics, but evidence is lacking as to whether this type of care is also valid as a means to identify risks to infants' social-emotional development. We aimed to examine the validity of such a family-centered approach. We conducted a prospective cohort study. During routine well-child visits (2-15 months), Preventive Child Healthcare (PCH) professionals used a family-centered approach, assessing domains as parents' competence, role of the partner, social support, barriers within the care-giving context, and child's wellbeing for 2976 children as protective, indistinct or a risk. If, based on the overall assessment (the families were labeled as "cases", N = 87), an intervention was considered necessary, parents filled in validated questionnaires covering the aforementioned domains. These questionnaires served as gold standards. For each case, two controls, matched by child-age and gender, also filled in questionnaires (N = 172). We compared PCH professionals' assessments with the parent-reported gold standards. Moreover, we evaluated which domain mostly contributed to the overall assessment. Spearman's rank correlation coefficients between PCH professionals' assessments and gold standards were overall reasonable (Spearman's rho 0.17-0.39) except for the domain barriers within the care-giving context. Scores on gold standards were significantly higher when PCH assessments were rated as "at risk" (overall and per domain).We found reasonable to excellent agreement regarding the absence of risk factors (negative agreement rate: 0.40-0.98), but lower agreement regarding the presence of risk factors (positive agreement rate: 0.00-0.67). An "at risk" assessment for the domain Barriers or life events within the care-giving context contributed most to being overall at risk, i.e. a case, odds ratio 100.1, 95%-confidence interval: 22.6 - infinity. Findings partially support the convergent validity of a family-centered approach in well-child care to assess infants' social-emotional wellbeing and their developmental context. Agreement was reasonable to excellent regarding protective factors, but lower regarding risk factors. Netherlands Trialregister, NTR2681. Date of registration: 05-01-2011, URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2681 .

The Dutch motor skills assessment as tool for talent development in table tennis: a reproducibility and validity study.

PubMed

Faber, Irene R; Nijhuis-Van Der Sanden, Maria W G; Elferink-Gemser, Marije T; Oosterveld, Frits G J

2015-01-01

A motor skills assessment could be helpful in talent development by estimating essential perceptuo-motor skills of young players, which are considered requisite to develop excellent technical and tactical qualities. The Netherlands Table Tennis Association uses a motor skills assessment in their talent development programme consisting of eight items measuring perceptuo-motor skills specific to table tennis under varying conditions. This study aimed to investigate this assessment regarding its reproducibility, internal consistency, underlying dimensions and concurrent validity in 113 young table tennis players (6-10 years). Intraclass correlation coefficients of six test items met the criteria of 0.7 with coefficients of variation between 3% and 8%. Cronbach's alpha valued 0.853 for internal consistency. The principal components analysis distinguished two conceptually meaningful factors: "ball control" and "gross motor function." Concurrent validity analyses demonstrated moderate associations between the motor skills assessment's results and national ranking; boys r = -0.53 (P < 0.001) and girls r = -0.45 (P = 0.015). In conclusion, this evaluation demonstrated six test items with acceptable reproducibility, good internal consistency and good prospects for validity. Two test items need revision to upgrade reproducibility. Since the motor skills assessment seems to be a reproducible, objective part of a talent development programme, more longitudinal studies are required to investigate its predictive validity.

Optimal Decision Stimuli for Risky Choice Experiments: An Adaptive Approach.

PubMed

Cavagnaro, Daniel R; Gonzalez, Richard; Myung, Jay I; Pitt, Mark A

2013-02-01

Collecting data to discriminate between models of risky choice requires careful selection of decision stimuli. Models of decision making aim to predict decisions across a wide range of possible stimuli, but practical limitations force experimenters to select only a handful of them for actual testing. Some stimuli are more diagnostic between models than others, so the choice of stimuli is critical. This paper provides the theoretical background and a methodological framework for adaptive selection of optimal stimuli for discriminating among models of risky choice. The approach, called Adaptive Design Optimization (ADO), adapts the stimulus in each experimental trial based on the results of the preceding trials. We demonstrate the validity of the approach with simulation studies aiming to discriminate Expected Utility, Weighted Expected Utility, Original Prospect Theory, and Cumulative Prospect Theory models.

Predicting sugar-sweetened behaviours with theory of planned behaviour constructs: Outcome and process results from the SIPsmartER behavioural intervention

PubMed Central

Zoellner, Jamie M.; Porter, Kathleen J.; Chen, Yvonnes; Hedrick, Valisa E.; You, Wen; Hickman, Maja; Estabrooks, Paul A.

2017-01-01

Objective Guided by the theory of planned behaviour (TPB) and health literacy concepts, SIPsmartER is a six-month multicomponent intervention effective at improving SSB behaviours. Using SIPsmartER data, this study explores prediction of SSB behavioural intention (BI) and behaviour from TPB constructs using: (1) cross-sectional and prospective models and (2) 11 single-item assessments from interactive voice response (IVR) technology. Design Quasi-experimental design, including pre- and post-outcome data and repeated-measures process data of 155 intervention participants. Main Outcome Measures Validated multi-item TPB measures, single-item TPB measures, and self-reported SSB behaviours. Hypothesised relationships were investigated using correlation and multiple regression models. Results TPB constructs explained 32% of the variance cross sectionally and 20% prospectively in BI; and explained 13–20% of variance cross sectionally and 6% prospectively. Single-item scale models were significant, yet explained less variance. All IVR models predicting BI (average 21%, range 6–38%) and behaviour (average 30%, range 6–55%) were significant. Conclusion Findings are interpreted in the context of other cross-sectional, prospective and experimental TPB health and dietary studies. Findings advance experimental application of the TPB, including understanding constructs at outcome and process time points and applying theory in all intervention development, implementation and evaluation phases. PMID:28165771

Prospective Patient-Related Outcome Evaluation of Secondary Cleft Rhinoplasty Using a Validated Questionnaire.

PubMed

Sawyer, Adam R; Robinson, Stephen; Cadier, Michael

2017-07-01

To evaluate patient satisfaction and quality of life following secondary cleft rhinoplasty. Prospective consecutive patient, single unit, single surgeon study. Spires Cleft Centre, Salisbury, Wilshire, United Kingdom, and private practice. 56 (27 secondary cleft rhinoplasty) patients completed evaluation forms preoperatively and 3 to 6 months postoperatively. Subjective assessment was performed using a validated Rhinoplasty Outcomes Evaluation (ROE) questionnaire. This instrument comprises six questions that capture three quality-of-life domains: physical, mental/emotional, and social. Rhinoplasty outcomes evaluation scores were calculated (range = 0 to 100) to indication satisfaction with rhinoplasty outcomes. Average age was 28 years (range = 18 to 59 years). There was a significant subjective improvement in the total ROE evaluation scores from 28 ± 10 to 80 ± 11 (P < .01) in secondary cleft rhinoplasty. Similar results were achieved in noncleft rhinoplasty 34 ± 9 to 84 ± 9 (P < .01). Specific scores for nasal aesthetic appearance improved from 0.3 ± 0.2 to 3.2 ± 0.3 (P < .01) in secondary cleft rhinoplasty. No significant change was seen in breathing capacity in secondary cleft rhinoplasty (from 2.7 ± 0.3 to 3.2 ± 0.2; P = .29). All patients said they would undergo the procedure again. Our results demonstrate high patient satisfaction after cleft rhinoplasty with particular regard to cosmetic appearance. These results are similar to those for noncleft rhinoplasty. We would recommend the use of this simple and quick validated outcome tool with all rhinoplasty patients.

Developing and validating risk prediction models in an individual participant data meta-analysis

PubMed Central

2014-01-01

Background Risk prediction models estimate the risk of developing future outcomes for individuals based on one or more underlying characteristics (predictors). We review how researchers develop and validate risk prediction models within an individual participant data (IPD) meta-analysis, in order to assess the feasibility and conduct of the approach. Methods A qualitative review of the aims, methodology, and reporting in 15 articles that developed a risk prediction model using IPD from multiple studies. Results The IPD approach offers many opportunities but methodological challenges exist, including: unavailability of requested IPD, missing patient data and predictors, and between-study heterogeneity in methods of measurement, outcome definitions and predictor effects. Most articles develop their model using IPD from all available studies and perform only an internal validation (on the same set of data). Ten of the 15 articles did not allow for any study differences in baseline risk (intercepts), potentially limiting their model’s applicability and performance in some populations. Only two articles used external validation (on different data), including a novel method which develops the model on all but one of the IPD studies, tests performance in the excluded study, and repeats by rotating the omitted study. Conclusions An IPD meta-analysis offers unique opportunities for risk prediction research. Researchers can make more of this by allowing separate model intercept terms for each study (population) to improve generalisability, and by using ‘internal-external cross-validation’ to simultaneously develop and validate their model. Methodological challenges can be reduced by prospectively planned collaborations that share IPD for risk prediction. PMID:24397587

Survival analysis with error-prone time-varying covariates: a risk set calibration approach

PubMed Central

Liao, Xiaomei; Zucker, David M.; Li, Yi; Spiegelman, Donna

2010-01-01

Summary Occupational, environmental, and nutritional epidemiologists are often interested in estimating the prospective effect of time-varying exposure variables such as cumulative exposure or cumulative updated average exposure, in relation to chronic disease endpoints such as cancer incidence and mortality. From exposure validation studies, it is apparent that many of the variables of interest are measured with moderate to substantial error. Although the ordinary regression calibration approach is approximately valid and efficient for measurement error correction of relative risk estimates from the Cox model with time-independent point exposures when the disease is rare, it is not adaptable for use with time-varying exposures. By re-calibrating the measurement error model within each risk set, a risk set regression calibration method is proposed for this setting. An algorithm for a bias-corrected point estimate of the relative risk using an RRC approach is presented, followed by the derivation of an estimate of its variance, resulting in a sandwich estimator. Emphasis is on methods applicable to the main study/external validation study design, which arises in important applications. Simulation studies under several assumptions about the error model were carried out, which demonstrated the validity and efficiency of the method in finite samples. The method was applied to a study of diet and cancer from Harvard’s Health Professionals Follow-up Study (HPFS). PMID:20486928

Linguistic and clinical validation of the Arabic-translated Aberdeen Menorrhagia Severity Scale as an indicator of quality of life for women with abnormal uterine bleeding.

PubMed

Abu-Rafea, Basim F; Vilos, George A; Al Jasser, Rakia S; Al Anazy, Reem M; Javaid, Khalida; Al-Mandeel, Hazem M

2012-08-01

To develop a conceptually and semantically valid Arabic version of a validated disease-specific instrument of quality of life (QoL) for women with abnormal uterine bleeding (AUB). This is a prospective cohort study conducted at the Department of Obstetrics & Gynecology, King Saud University, Riyadh, Kingdom of Saudi Arabia between December 2010 and December 2011 following ethics approval. Forward translation of the Aberdeen Menorrhagia Severity Scale (AMSS) from English into Arabic was followed by backward translation of the consensus target (Arabic) version into the source (English) language. Subsequently, a final target (Arabic) language version was created. Sixty-one Arabic-speaking women of reproductive age participated in the study. The final Arabic questionnaire was administered to 41 women with self-perceived normal menses (Group 1) on 2 occasions 2 weeks apart. Agreement in the answers deems the questionnaire reliable. The final Arabic version was administered to 20 women with self-perceived AUB (Group 2), and their scores were compared with the first response of Group 1. A significant difference between the groups deems the questionnaire valid. For linguistic validation; intra-class correlation coefficient (ICC) of 0.87 and Kappa statistics of 0.56 to 0.87 indicated good to excellent agreement. For clinical validation, there was a significant difference between Group 1 and 2 (p=0.001). The translated Arabic AMSS is a reliable and valid indicator of QoL in Saudi women with AUB.

Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX.

PubMed

Emile, Jean-François; Julié, Catherine; Le Malicot, Karine; Lepage, Come; Tabernero, Josep; Mini, Enrico; Folprecht, Gunnar; Van Laethem, Jean-Luc; Dimet, Stéphanie; Boulagnon-Rombi, Camille; Allard, Marc-Antoine; Penault-Llorca, Frédérique; Bennouna, Jaafar; Laurent-Puig, Pierre; Taieb, Julien

2017-09-01

The prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use. According to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study. Primary objective was to compare percentage of patients alive and without recurrence at 2 years in patients with high versus low LI (#NCT02364024). Associations of LI with patient recurrence and survival were analysed, and multivariable models were adjusted for treatment and relevant factors. Automated testing of LI was performed on virtual slides without access to clinical data. Among the 1220 CC patients enrolled, LI was high, low and not evaluable in 241 (19.8%), 790 (64.8%) and 189 (15.5%), respectively. Primary objective was met with a 2-year recurrence rate of 14.4% versus 21.1% in patients with high and low LI, respectively (p = 0.02). Patients with high LI also had better disease free survival (DFS) and overall survival (OS). Tumour stage, grade, RAS status and BRAF status were with LI the only prognostic markers in multivariable analysis for OS. Subgroup analyses revealed that high LI had better DFS and OS in mismatch repair (MMR) proficient patients, and in patients without RAS mutation, but not in MMR deficient and RAS mutated patients. Although this is the first validation with high level of evidence (IIB) of the prognostic value of a LI test in colon cancers, it still needs to be confirmed in independent series of colon cancer patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Field Validation of the Los Angeles Motor Scale as a Tool for Paramedic Assessment of Stroke Severity.

PubMed

Kim, Joon-Tae; Chung, Pil-Wook; Starkman, Sidney; Sanossian, Nerses; Stratton, Samuel J; Eckstein, Marc; Pratt, Frank D; Conwit, Robin; Liebeskind, David S; Sharma, Latisha; Restrepo, Lucas; Tenser, May-Kim; Valdes-Sueiras, Miguel; Gornbein, Jeffrey; Hamilton, Scott; Saver, Jeffrey L

2017-02-01

The Los Angeles Motor Scale (LAMS) is a 3-item, 0- to 10-point motor stroke-deficit scale developed for prehospital use. We assessed the convergent, divergent, and predictive validity of the LAMS when performed by paramedics in the field at multiple sites in a large and diverse geographic region. We analyzed early assessment and outcome data prospectively gathered in the FAST-MAG trial (Field Administration of Stroke Therapy-Magnesium phase 3) among patients with acute cerebrovascular disease (cerebral ischemia and intracranial hemorrhage) within 2 hours of onset, transported by 315 ambulances to 60 receiving hospitals. Among 1632 acute cerebrovascular disease patients (age 70±13 years, male 57.5%), time from onset to prehospital LAMS was median 30 minutes (interquartile range 20-50), onset to early postarrival (EPA) LAMS was 145 minutes (interquartile range 119-180), and onset to EPA National Institutes of Health Stroke Scale was 150 minutes (interquartile range 120-180). Between the prehospital and EPA assessments, LAMS scores were stable in 40.5%, improved in 37.6%, and worsened in 21.9%. In tests of convergent validity, against the EPA National Institutes of Health Stroke Scale, correlations were r=0.49 for the prehospital LAMS and r=0.89 for the EPA LAMS. Prehospital LAMS scores did diverge from the prehospital Glasgow Coma Scale, r=-0.22. Predictive accuracy (adjusted C statistics) for nondisabled 3-month outcome was as follows: prehospital LAMS, 0.76 (95% confidence interval 0.74-0.78); EPA LAMS, 0.85 (95% confidence interval 0.83-0.87); and EPA National Institutes of Health Stroke Scale, 0.87 (95% confidence interval 0.85-0.88). In this multicenter, prospective, prehospital study, the LAMS showed good to excellent convergent, divergent, and predictive validity, further establishing it as a validated instrument to characterize stroke severity in the field. © 2017 American Heart Association, Inc.

Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325).

PubMed

Dehing-Oberije, Cary; Aerts, Hugo; Yu, Shipeng; De Ruysscher, Dirk; Menheere, Paul; Hilvo, Mika; van der Weide, Hiska; Rao, Bharat; Lambin, Philippe

2011-10-01

Currently, prediction of survival for non-small-cell lung cancer patients treated with (chemo)radiotherapy is mainly based on clinical factors. The hypothesis of this prospective study was that blood biomarkers related to hypoxia, inflammation, and tumor load would have an added prognostic value for predicting survival. Clinical data and blood samples were collected prospectively (NCT00181519, NCT00573040, and NCT00572325) from 106 inoperable non-small-cell lung cancer patients (Stages I-IIIB), treated with curative intent with radiotherapy alone or combined with chemotherapy. Blood biomarkers, including lactate dehydrogenase, C-reactive protein, osteopontin, carbonic anhydrase IX, interleukin (IL) 6, IL-8, carcinoembryonic antigen (CEA), and cytokeratin fragment 21-1, were measured. A multivariate model, built on a large patient population (N = 322) and externally validated, was used as a baseline model. An extended model was created by selecting additional biomarkers. The model's performance was expressed as the area under the curve (AUC) of the receiver operating characteristic and assessed by use of leave-one-out cross validation as well as a validation cohort (n = 52). The baseline model consisted of gender, World Health Organization performance status, forced expiratory volume, number of positive lymph node stations, and gross tumor volume and yielded an AUC of 0.72. The extended model included two additional blood biomarkers (CEA and IL-6) and resulted in a leave-one-out AUC of 0.81. The performance of the extended model was significantly better than the clinical model (p = 0.004). The AUC on the validation cohort was 0.66 and 0.76, respectively. The performance of the prognostic model for survival improved markedly by adding two blood biomarkers: CEA and IL-6. Copyright © 2011 Elsevier Inc. All rights reserved.

Nomogram-based prediction of survival in patients with advanced oesophagogastric adenocarcinoma receiving first-line chemotherapy: a multicenter prospective study in the era of trastuzumab.

PubMed

Custodio, A; Carmona-Bayonas, A; Jiménez-Fonseca, P; Sánchez, M L; Viudez, A; Hernández, R; Cano, J M; Echavarria, I; Pericay, C; Mangas, M; Visa, L; Buxo, E; García, T; Rodríguez Palomo, A; Álvarez Manceñido, F; Lacalle, A; Macias, I; Azkarate, A; Ramchandani, A; Fernández Montes, A; López, C; Longo, F; Sánchez Bayona, R; Limón, M L; Díaz-Serrano, A; Hurtado, A; Madero, R; Gómez, C; Gallego, J

2017-06-06

To develop and validate a nomogram and web-based calculator to predict overall survival (OS) in Caucasian-advanced oesophagogastric adenocarcinoma (AOA) patients undergoing first-line combination chemotherapy. Nine hundred twenty-four AOA patients treated at 28 Spanish teaching hospitals from January 2008 to September 2014 were used as derivation cohort. The result of an adjusted-Cox proportional hazards regression was represented as a nomogram and web-based calculator. The model was validated in 502 prospectively recruited patients treated between October 2014 and December 2016. Harrell's c-index was used to evaluate discrimination. The nomogram includes seven predictors associated with OS: HER2-positive tumours treated with trastuzumab, Eastern Cooperative Oncology Group performance status, number of metastatic sites, bone metastases, ascites, histological grade, and neutrophil-to-lymphocyte ratio. Median OS was 5.8 (95% confidence interval (CI), 4.5-6.6), 9.4 (95% CI, 8.5-10.6), and 14 months (95% CI, 11.8-16) for high-, intermediate-, and low-risk groups, respectively (P<0.001), in the derivation set and 4.6 (95% CI, 3.3-8.1), 12.7 (95% CI, 11.3-14.3), and 18.3 months (95% CI, 14.6-24.2) for high-, intermediate-, and low-risk groups, respectively (P<0.001), in the validation set. The nomogram is well-calibrated and reveals acceptable discriminatory capacity, with optimism-corrected c-indices of 0.618 (95% CI, 0.591-0.631) and 0.673 (95% CI, 0.636-0.709) in derivation and validation groups, respectively. The AGAMENON nomogram outperformed the Royal Marsden Hospital (c-index=0.583; P=0.00046) and Japan Clinical Oncology Group prognostic indices (c-index=0.611; P=0.03351). We developed and validated a straightforward model to predict survival in Caucasian AOA patients initiating first-line polychemotherapy. This model can contribute to inform clinical decision-making and optimise clinical trial design.

The Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL): a pilot study exploring validity and feasibility in clinical practice.

PubMed

Bush, Shirley H; Grassau, Pamela A; Yarmo, Michelle N; Zhang, Tinghua; Zinkie, Samantha J; Pereira, José L

2014-03-31

The Richmond Agitation-Sedation Scale (RASS), which assesses level of sedation and agitation, is a simple observational instrument which was developed and validated for the intensive care setting. Although used and recommended in palliative care settings, further validation is required in this patient population. The aim of this study was to explore the validity and feasibility of a version of the RASS modified for palliative care populations (RASS-PAL). A prospective study, using a mixed methods approach, was conducted. Thirteen health care professionals (physicians and nurses) working in an acute palliative care unit assessed ten consecutive patients with an agitated delirium or receiving palliative sedation. Patients were assessed at five designated time points using the RASS-PAL. Health care professionals completed a short survey and data from semi-structured interviews was analyzed using thematic analysis. The inter-rater intraclass correlation coefficient range of the RASS-PAL was 0.84 to 0.98 for the five time points. Professionals agreed that the tool was useful for assessing sedation and was easy to use. Its role in monitoring delirium however was deemed problematic. Professionals felt that it may assist interprofessional communication. The need for formal education on why and how to use the instrument was highlighted. This study provides preliminary validity evidence for the use of the RASS-PAL by physicians and nurses working in a palliative care unit, specifically for assessing sedation and agitation levels in the management of palliative sedation. Further validity evidence should be sought, particularly in the context of assessing delirium.

Screening Poststroke Fatigue; Feasibility and Validation of an Instrument for the Screening of Poststroke Fatigue throughout the Rehabilitation Process.

PubMed

Kruithof, Nena; Van Cleef, Melanie Hubertina Maria; Rasquin, Sascha Maria Cornelia; Bovend'Eerdt, Thamar Johannes Henricus

2016-01-01

Our objective is to investigate the feasibility and validity of a new instrument to screen for determinants of poststroke fatigue during the rehabilitation process. This prospective cohort study was conducted within the stroke department of a rehabilitation center. The participants in the study were postacute adult stroke patients. The Detection List Fatigue (DLF)was administered 2 weeks after the start of the rehabilitation program and again 6 weeks later. To determine the construct validity, the Hospital Anxiety and Depression Scale, the Checklist Individual Strength subscale fatigue, and the Fatigue Severity Scale--7-item version were administered. A fatigue rating scale was used to measure the patients' fatigue experience. Frequency analyses of the number of patients reporting poststroke fatigue determinants according to the DLF were performed. One hundred seven patients (mean age 60 years) without severe communication difficulties were included in the study. The DLF was easy to understand and quick to administer. The DLF showed good internal consistency (Cronbach's alpha: .79 and .87), high convergent validity (rs = .85 and rs = .79), and good divergent validity (rs = .31 and rs = .45). The majority of the patients (88.4%-90.2%) experienced at least 2 poststroke fatigue (PSF) determinants,of which "sleeping problem" was most frequently reported. The DLF is a feasible and valid instrument for the screening of PSF determinants throughout the rehabilitation process in stroke patients. Future studies should investigate whether the use of the list in determining a treatment plan prevents the development of PSF.

Prospect of stem cell conditioned medium in regenerative medicine.

PubMed

Pawitan, Jeanne Adiwinata

2014-01-01

Stem cell-derived conditioned medium has a promising prospect to be produced as pharmaceuticals for regenerative medicine. To investigate various methods to obtain stem cell-derived conditioned medium (CM) to get an insight into their prospect of application in various diseases. Systematic review using keywords "stem cell" and "conditioned medium" or "secretome" and "therapy." Data concerning treated conditions/diseases, type of cell that was cultured, medium and supplements to culture the cells, culture condition, CM processing, growth factors and other secretions that were analyzed, method of application, and outcome were noted, grouped, tabulated, and analyzed. Most of CM using studies showed good results. However, the various CM, even when they were derived from the same kind of cells, were produced by different condition, that is, from different passage, culture medium, and culture condition. The growth factor yields of the various types of cells were available in some studies, and the cell number that was needed to produce CM for one application could be computed. Various stem cell-derived conditioned media were tested on various diseases and mostly showed good results. However, standardized methods of production and validations of their use need to be conducted.

Development and validation of risk prediction algorithms to estimate future risk of common cancers in men and women: prospective cohort study

PubMed Central

Hippisley-Cox, Julia; Coupland, Carol

2015-01-01

Objective To derive and validate a set of clinical risk prediction algorithm to estimate the 10-year risk of 11 common cancers. Design Prospective open cohort study using routinely collected data from 753 QResearch general practices in England. We used 565 practices to develop the scores and 188 for validation. Subjects 4.96 million patients aged 25–84 years in the derivation cohort; 1.64 million in the validation cohort. Patients were free of the relevant cancer at baseline. Methods Cox proportional hazards models in the derivation cohort to derive 10-year risk algorithms. Risk factors considered included age, ethnicity, deprivation, body mass index, smoking, alcohol, previous cancer diagnoses, family history of cancer, relevant comorbidities and medication. Measures of calibration and discrimination in the validation cohort. Outcomes Incident cases of blood, breast, bowel, gastro-oesophageal, lung, oral, ovarian, pancreas, prostate, renal tract and uterine cancers. Cancers were recorded on any one of four linked data sources (general practitioner (GP), mortality, hospital or cancer records). Results We identified 228 241 incident cases during follow-up of the 11 types of cancer. Of these 25 444 were blood; 41 315 breast; 32 626 bowel, 12 808 gastro-oesophageal; 32 187 lung; 4811 oral; 6635 ovarian; 7119 pancreatic; 35 256 prostate; 23 091 renal tract; 6949 uterine cancers. The lung cancer algorithm had the best performance with an R2 of 64.2%; D statistic of 2.74; receiver operating characteristic curve statistic of 0.91 in women. The sensitivity for the top 10% of women at highest risk of lung cancer was 67%. Performance of the algorithms in men was very similar to that for women. Conclusions We have developed and validated a prediction models to quantify absolute risk of 11 common cancers. They can be used to identify patients at high risk of cancers for prevention or further assessment. The algorithms could be integrated into clinical computer systems and used to identify high-risk patients. Web calculator: There is a simple web calculator to implement the Qcancer 10 year risk algorithm together with the open source software for download (available at http://qcancer.org/10yr/). PMID:25783428

Limited-sampling strategies for anti-infective agents: systematic review.

PubMed

Sprague, Denise A; Ensom, Mary H H

2009-09-01

Area under the concentration-time curve (AUC) is a pharmacokinetic parameter that represents overall exposure to a drug. For selected anti-infective agents, pharmacokinetic-pharmacodynamic parameters, such as AUC/MIC (where MIC is the minimal inhibitory concentration), have been correlated with outcome in a few studies. A limited-sampling strategy may be used to estimate pharmacokinetic parameters such as AUC, without the frequent, costly, and inconvenient blood sampling that would be required to directly calculate the AUC. To discuss, by means of a systematic review, the strengths, limitations, and clinical implications of published studies involving a limited-sampling strategy for anti-infective agents and to propose improvements in methodology for future studies. The PubMed and EMBASE databases were searched using the terms "anti-infective agents", "limited sampling", "optimal sampling", "sparse sampling", "AUC monitoring", "abbreviated AUC", "abbreviated sampling", and "Bayesian". The reference lists of retrieved articles were searched manually. Included studies were classified according to modified criteria from the US Preventive Services Task Force. Twenty studies met the inclusion criteria. Six of the studies (involving didanosine, zidovudine, nevirapine, ciprofloxacin, efavirenz, and nelfinavir) were classified as providing level I evidence, 4 studies (involving vancomycin, didanosine, lamivudine, and lopinavir-ritonavir) provided level II-1 evidence, 2 studies (involving saquinavir and ceftazidime) provided level II-2 evidence, and 8 studies (involving ciprofloxacin, nelfinavir, vancomycin, ceftazidime, ganciclovir, pyrazinamide, meropenem, and alpha interferon) provided level III evidence. All of the studies providing level I evidence used prospectively collected data and proper validation procedures with separate, randomly selected index and validation groups. However, most of the included studies did not provide an adequate description of the methods or the characteristics of included patients, which limited their generalizability. Many limited-sampling strategies have been developed for anti-infective agents that do not have a clearly established link between AUC and clinical outcomes in humans. Future studies should first determine if there is an association between AUC monitoring and clinical outcomes. Thereafter, it may be worthwhile to prospectively develop and validate a limited-sampling strategy for the particular anti-infective agent in a similar population.

Cross-cultural adaptation and validation of als Functional Rating Scale-Revised in Portuguese language.

PubMed

Guedes, Keyte; Pereira, Cecília; Pavan, Karina; Valério, Berenice Cataldo Oliveira

2010-02-01

The aim of this study is the cross-cultural, as well as to validate in Portuguese language the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R). We performed a prospective study of individuals with amyotrophic lateral sclerosis (ALS) clinically defined. The scale, after obtaining the final version in Portuguese, was administered in 22 individuals and three weeks after re-applied. There were no significant differences between the application and reapplication of the scale (p=0.069). The linear regression and internal consistency measured by Pearson correlation and alpha Conbrach were significant with r=0.975 e alpha=0.934. The reliability test-retest demonstrated by intraclass correlation coefficient was strong with ICC=0.975. Therefore, this version proved to be applicable, reliable and easy to be conducted in clinical practice and research.

Clinical validity of the estimated energy requirement and the average protein requirement for nutritional status change and wound healing in older patients with pressure ulcers: A multicenter prospective cohort study.

PubMed

Iizaka, Shinji; Kaitani, Toshiko; Nakagami, Gojiro; Sugama, Junko; Sanada, Hiromi

2015-11-01

Adequate nutritional intake is essential for pressure ulcer healing. Recently, the estimated energy requirement (30 kcal/kg) and the average protein requirement (0.95 g/kg) necessary to maintain metabolic balance have been reported. The purpose was to evaluate the clinical validity of these requirements in older hospitalized patients with pressure ulcers by assessing nutritional status and wound healing. This multicenter prospective study carried out as a secondary analysis of a clinical trial included 194 patients with pressure ulcers aged ≥65 years from 29 institutions. Nutritional status including anthropometry and biochemical tests, and wound status by a structured severity tool, were evaluated over 3 weeks. Energy and protein intake were determined from medical records on a typical day and dichotomized by meeting the estimated average requirement. Longitudinal data were analyzed with a multivariate mixed-effects model. Meeting the energy requirement was associated with changes in weight (P < 0.001), arm muscle circumference (P = 0.003) and serum albumin level (P = 0.016). Meeting the protein requirement was associated with changes in weight (P < 0.001) and serum albumin level (P = 0.043). These markers decreased in patients who did not meet the requirement, but were stable or increased in those who did. Energy and protein intake were associated with wound healing for deep ulcers (P = 0.013 for both), improving exudates and necrotic tissue, but not for superficial ulcers. Estimated energy requirement and average protein requirement were clinically validated for prevention of nutritional decline and of impaired healing of deep pressure ulcers. © 2014 Japan Geriatrics Society.

Novel biomarker-based model for the prediction of sorafenib response and overall survival in advanced hepatocellular carcinoma: a prospective cohort study.

PubMed

Kim, Hwi Young; Lee, Dong Hyeon; Lee, Jeong-Hoon; Cho, Young Youn; Cho, Eun Ju; Yu, Su Jong; Kim, Yoon Jun; Yoon, Jung-Hwan

2018-03-20

Prediction of the outcome of sorafenib therapy using biomarkers is an unmet clinical need in patients with advanced hepatocellular carcinoma (HCC). The aim was to develop and validate a biomarker-based model for predicting sorafenib response and overall survival (OS). This prospective cohort study included 124 consecutive HCC patients (44 with disease control, 80 with progression) with Child-Pugh class A liver function, who received sorafenib. Potential serum biomarkers (namely, hepatocyte growth factor [HGF], fibroblast growth factor [FGF], vascular endothelial growth factor receptor-1, CD117, and angiopoietin-2) were tested. After identifying independent predictors of tumor response, a risk scoring system for predicting OS was developed and 3-fold internal validation was conducted. A risk scoring system was developed with six covariates: etiology, platelet count, Barcelona Clinic Liver Cancer stage, protein induced by vitamin K absence-II, HGF, and FGF. When patients were stratified into low-risk (score ≤ 5), intermediate-risk (score 6), and high-risk (score ≥ 7) groups, the model provided good discriminant functions on tumor response (concordance [c]-index, 0.884) and 12-month survival (area under the curve [AUC], 0.825). The median OS was 19.0, 11.2, and 6.1 months in the low-, intermediate-, and high-risk group, respectively (P < 0.001). In internal validation, the model maintained good discriminant functions on tumor response (c-index, 0.825) and 12-month survival (AUC, 0.803), and good calibration functions (all P > 0.05 between expected and observed values). This new model including serum FGF and HGF showed good performance in predicting the response to sorafenib and survival in patients with advanced HCC.

Biomarker validation of recent unprotected sexual intercourse in a prospective study of young women engaged in sex work in Phnom Penh, Cambodia.

PubMed

Evans, Jennifer L; Couture, Marie-Claude; Stein, Ellen S; Sansothy, Neth; Maher, Lisa; Page, Kimberly

2013-06-01

Accurate measurement of unprotected sex is essential in HIV prevention research. Since 2001, the 100% Condom Use Program targeting female sex workers (FSWs) has been a central element of the Cambodian National HIV/AIDS Strategy. We sought to assess the validity of self-reported condom use using the rapid prostate-specific antigen (PSA) test among Cambodian FSWs. From 2009 to 2010, we enrolled 183 FSWs in Phnom Penh in a prospective study of HIV risk behavior. Prostate-specific antigen test results from the OneStep ABAcard were compared with self-reported condom use in the past 48 hours at quarterly follow-up visits. Among women positive for seminal fluid at the first follow-up visit, 42% reported only protected sex or no sex in the detection period. Discordant results were more likely among brothel and street-based FSW versus entertainment (56% vs. 17%), recent (last 3 months) amphetamine-type stimulant (ATS) users (53% vs. 20%), and those with 5 or more partners in the past month (58% vs. 13%). In multivariable regression models, positive PSA results were associated with recent ATS use (adjusted risk ratio [ARR], 1.5; 95% confidence interval [CI], 1.1-2.2), having a nonpaying last sex partner (ARR, 1.7; CI, 1.2-2.5), and sex work venue (ARR, 3.0; CI, 1.4-6.5). Correspondingly, women with a nonpaying last sex partner were more likely to report unprotected sex (ARR, 1.5; CI, 1.1-2.2), but no associations were found with sex work venue or ATS use. Results confirm the questionable validity of self-reported condom use among FSW. The PSA biomarker assay is an important monitoring tool in HIV/sexually transmitted infection research including prevention trials.

Lung Cancer Risk Prediction Model Incorporating Lung Function: Development and Validation in the UK Biobank Prospective Cohort Study.

PubMed

Muller, David C; Johansson, Mattias; Brennan, Paul

2017-03-10

Purpose Several lung cancer risk prediction models have been developed, but none to date have assessed the predictive ability of lung function in a population-based cohort. We sought to develop and internally validate a model incorporating lung function using data from the UK Biobank prospective cohort study. Methods This analysis included 502,321 participants without a previous diagnosis of lung cancer, predominantly between 40 and 70 years of age. We used flexible parametric survival models to estimate the 2-year probability of lung cancer, accounting for the competing risk of death. Models included predictors previously shown to be associated with lung cancer risk, including sex, variables related to smoking history and nicotine addiction, medical history, family history of lung cancer, and lung function (forced expiratory volume in 1 second [FEV1]). Results During accumulated follow-up of 1,469,518 person-years, there were 738 lung cancer diagnoses. A model incorporating all predictors had excellent discrimination (concordance (c)-statistic [95% CI] = 0.85 [0.82 to 0.87]). Internal validation suggested that the model will discriminate well when applied to new data (optimism-corrected c-statistic = 0.84). The full model, including FEV1, also had modestly superior discriminatory power than one that was designed solely on the basis of questionnaire variables (c-statistic = 0.84 [0.82 to 0.86]; optimism-corrected c-statistic = 0.83; p FEV1 = 3.4 × 10 -13 ). The full model had better discrimination than standard lung cancer screening eligibility criteria (c-statistic = 0.66 [0.64 to 0.69]). Conclusion A risk prediction model that includes lung function has strong predictive ability, which could improve eligibility criteria for lung cancer screening programs.

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.

Development of a PROficiency-Based StePwise Endovascular Curricular Training (PROSPECT) Program.

PubMed

Maertens, Heidi; Aggarwal, Rajesh; Desender, Liesbeth; Vermassen, Frank; Van Herzeele, Isabelle

2016-01-01

Focus on patient safety, work-hour limitations, and cost-effective education is putting pressure to improve curricula to acquire minimally invasive techniques during surgical training. This study aimed to design a structured training program for endovascular skills and validate its assessment methods. A PROficiency-based StePwise Endovascular Curricular Training (PROSPECT) program was developed, consisting of e-learning and hands-on simulation modules, focusing on iliac and superficial femoral artery atherosclerotic disease. Construct validity was investigated. Performances were assessed using multiple-choice questionnaires, valid simulation parameters, global rating scorings, and examiner checklists. Feasibility was assessed by passage of 2 final-year medical students through this PROSPECT program. Ghent University Hospital, a tertiary clinical care and academic center in Belgium with general surgery residency program. Senior-year medical students were recruited at Ghent University Hospital. Vascular surgeons were invited to participate during conferences and meetings if they had performed at least 100 endovascular procedures as the primary operator during the last 2 years. Overall, 29 medical students and 20 vascular surgeons participated. Vascular surgeons obtained higher multiple-choice questionnaire scores (median: 24.5-22.0 vs. 15.0-12.0; p < 0.001). Students took significantly longer to treat any iliac or femoral artery stenosis (3.3-14.8 vs. 5.8-30.1min; p = 0.001-0.04), whereas in more complex cases, fluoroscopy time was significantly higher in students (8.3 vs. 21.3min; p = 0.002; 7.3 vs. 13.1min; p = 0.03). In all cases, vascular surgeons scored higher on global rating scorings (51.0-42.0 vs. 29.5-18.0; p < 0.001) and examiner checklist (81.5-75.0 vs. 54.5-43.0; p < 0.001). Hence, proficiency levels based on median expert scores could be determined. There were 2 students who completed the program and passed for each step within a 3-month period during their internships. A feasible and construct validated surgical program to train cognitive, technical, and nontechnical endovascular skills was developed. A structured, stepwise, proficiency-based valid endovascular program to train cognitive, technical, and human factor skills has been developed and proven to be feasible. A randomized controlled trial has been initiated to investigate its effect on performances in real life, patient outcomes, and cost-effectiveness. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Which factors are most predictive for live birth after in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) treatments? Analysis of 100 prospectively recorded variables in 8,400 IVF/ICSI single-embryo transfers.

PubMed

Vaegter, Katarina Kebbon; Lakic, Tatevik Ghukasyan; Olovsson, Matts; Berglund, Lars; Brodin, Thomas; Holte, Jan

2017-03-01

To construct a prediction model for live birth after in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment and single-embryo transfer (SET) after 2 days of embryo culture. Prospective observational cohort study. University-affiliated private infertility center. SET in 8,451 IVF/ICSI treatments in 5,699 unselected consecutive couples during 1999-2014. A total of 100 basal patient characteristics and treatment data were analyzed for associations with live birth after IVF/ICSI (adjusted for repeated treatments) and subsequently combined for prediction model construction. Live birth rate (LBR) and performance of live birth prediction model. Embryo score, treatment history, ovarian sensitivity index (OSI; number of oocytes/total dose of FSH administered), female age, infertility cause, endometrial thickness, and female height were all independent predictors of live birth. A prediction model (training data set; n = 5,722) based on these variables showed moderate discrimination, but predicted LBR with high accuracy in subgroups of patients, with LBR estimates ranging from <10% to >40%. Outcomes were similar in an internal validation data set (n = 2,460). Based on 100 variables prospectively recorded during a 15-year period, a model for live birth prediction after strict SET was constructed and showed excellent calibration in internal validation. For the first time, female height qualified as a predictor of live birth after IVF/ICSI. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Estimation of geotechnical parameters on the basis of geophysical methods and geostatistics

NASA Astrophysics Data System (ADS)

Brom, Aleksander; Natonik, Adrianna

2017-12-01

The paper presents possible implementation of ordinary cokriging and geophysical investigation on humidity data acquired in geotechnical studies. The Author describes concept of geostatistics, terminology of geostatistical modelling, spatial correlation functions, principles of solving cokriging systems, advantages of (co-)kriging in comparison with other interpolation methods, obstacles in this type of attempt. Cross validation and discussion of results was performed with an indication of prospect of applying similar procedures in various researches..

Job decision latitude, job demands, and cardiovascular disease: a prospective study of Swedish men.

PubMed Central

Karasek, R; Baker, D; Marxer, F; Ahlbom, A; Theorell, T

1981-01-01

The association between specific job characteristics and subsequent cardiovascular disease was tested using a large random sample of the male working Swedish population. The prospective development of coronary heart disease (CHD) symptoms and signs was analyzed using a multivariate logistic regression technique. Additionally, a case-controlled study was used to analyze all cardiovascular-cerebrovascular (CHD-CVD) deaths during a six-year follow-up. The indicator of CHD symptoms and signs was validated in a six-year prospective study of CHD deaths (standardized mortality ratio 5.0; p less than or equal to .001). A hectic and psychologically demanding job increases the risk of developing CHD symptoms and signs (standardized odds ratio 1.29, p less than 0.25) and premature CHD-CVD death (relative risk 4.0, p less than .01). Low decision latitude-expressed as low intellectual discretion and low personal schedule freedom-is also associated with increased risk of cardiovascular disease. Low intellectual discretion predicts the development of CHD symptoms and signs (SOR 1.44, p less than .01), while low personal schedule freedom among the majority of workers with the minimum statutory education increases the risk of CHD-CVD death (RR 6.6, p less than .0002). The associations exist after controlling for age, education, smoking, and overweight. PMID:7246835

Job decision latitude, job demands, and cardiovascular disease: a prospective study of Swedish men.

PubMed

Karasek, R; Baker, D; Marxer, F; Ahlbom, A; Theorell, T

1981-07-01

The association between specific job characteristics and subsequent cardiovascular disease was tested using a large random sample of the male working Swedish population. The prospective development of coronary heart disease (CHD) symptoms and signs was analyzed using a multivariate logistic regression technique. Additionally, a case-controlled study was used to analyze all cardiovascular-cerebrovascular (CHD-CVD) deaths during a six-year follow-up. The indicator of CHD symptoms and signs was validated in a six-year prospective study of CHD deaths (standardized mortality ratio 5.0; p less than or equal to .001). A hectic and psychologically demanding job increases the risk of developing CHD symptoms and signs (standardized odds ratio 1.29, p less than 0.25) and premature CHD-CVD death (relative risk 4.0, p less than .01). Low decision latitude-expressed as low intellectual discretion and low personal schedule freedom-is also associated with increased risk of cardiovascular disease. Low intellectual discretion predicts the development of CHD symptoms and signs (SOR 1.44, p less than .01), while low personal schedule freedom among the majority of workers with the minimum statutory education increases the risk of CHD-CVD death (RR 6.6, p less than .0002). The associations exist after controlling for age, education, smoking, and overweight.

Predictive validity of granulation tissue color measured by digital image analysis for deep pressure ulcer healing: a multicenter prospective cohort study.

PubMed

Iizaka, Shinji; Kaitani, Toshiko; Sugama, Junko; Nakagami, Gojiro; Naito, Ayumi; Koyanagi, Hiroe; Konya, Chizuko; Sanada, Hiromi

2013-01-01

This multicenter prospective cohort study examined the predictive validity of granulation tissue color evaluated by digital image analysis for deep pressure ulcer healing. Ninety-one patients with deep pressure ulcers were followed for 3 weeks. From a wound photograph taken at baseline, an image representing the granulation red index (GRI) was processed in which a redder color represented higher values. We calculated the average GRI over granulation tissue and the proportion of pixels exceeding the threshold intensity of 80 for the granulation tissue surface (%GRI80) and wound surface (%wound red index 80). In the receiver operating characteristics curve analysis, most GRI parameters had adequate discriminative values for both improvement of the DESIGN-R total score and wound closure. Ulcers were categorized by the obtained cutoff points of the average GRI (≤80, >80), %GRI80 (≤55, >55-80, >80%), and %wound red index 80 (≤25, >25-50, >50%). In the linear mixed model, higher classes for all GRI parameters showed significantly greater relative improvement in overall wound severity during the 3 weeks after adjustment for patient characteristics and wound locations. Assessment of granulation tissue color by digital image analysis will be useful as an objective monitoring tool for granulation tissue quality or surrogate outcomes of pressure ulcer healing. © 2012 by the Wound Healing Society.

A simple web-based risk calculator (www.anastomoticleak.com) is superior to the surgeon's estimate of anastomotic leak after colon cancer resection.

PubMed

Sammour, T; Lewis, M; Thomas, M L; Lawrence, M J; Hunter, A; Moore, J W

2017-01-01

Anastomotic leak can be a devastating complication, and early prediction is difficult. The aim of this study is to prospectively validate a simple anastomotic leak risk calculator and compare its predictive value with the estimate of the primary operating surgeon. Consecutive patients undergoing elective or emergency colon cancer surgery with a primary anastomosis over a 1-year period were prospectively included. A recently published anastomotic leak risk nomogram was converted to an online calculator ( www.anastomoticleak.com ). The calculator-derived risk of anastomotic leak and the risk estimated by the primary operating surgeon were recorded at the completion of surgery. The primary outcome was anastomotic leak within 90 days as defined by previously published criteria. Area under receiver operating characteristic curve analysis (AUROC) was performed for both risk estimates. A total of 105 patients were screened for inclusion during the study period, of whom 83 met the inclusion criteria. The overall anastomotic leak rate was 9.6%. The anastomotic leak calculator was highly predictive of anastomotic leak (AUROC 0.84, P = 0.002), whereas the surgeon estimate was not predictive (AUROC 0.40, P = 0.243). A simple anastomotic leak risk calculator is significantly better at predicting anastomotic leak than the estimate of the primary surgeon. Further external validation on a larger data set is required.

Empirically Derived Dehydration Scoring and Decision Tree Models for Children With Diarrhea: Assessment and Internal Validation in a Prospective Cohort Study in Dhaka, Bangladesh

PubMed Central

Glavis-Bloom, Justin; Modi, Payal; Nasrin, Sabiha; Rege, Soham; Chu, Chieh; Schmid, Christopher H; Alam, Nur H

2015-01-01

Introduction: Diarrhea remains one of the most common and most deadly conditions affecting children worldwide. Accurately assessing dehydration status is critical to determining treatment course, yet no clinical diagnostic models for dehydration have been empirically derived and validated for use in resource-limited settings. Methods: In the Dehydration: Assessing Kids Accurately (DHAKA) prospective cohort study, a random sample of children under 5 with acute diarrhea was enrolled between February and June 2014 in Bangladesh. Local nurses assessed children for clinical signs of dehydration on arrival, and then serial weights were obtained as subjects were rehydrated. For each child, the percent weight change with rehydration was used to classify subjects with severe dehydration (>9% weight change), some dehydration (3–9%), or no dehydration (<3%). Clinical variables were then entered into logistic regression and recursive partitioning models to develop the DHAKA Dehydration Score and DHAKA Dehydration Tree, respectively. Models were assessed for their accuracy using the area under their receiver operating characteristic curve (AUC) and for their reliability through repeat clinical exams. Bootstrapping was used to internally validate the models. Results: A total of 850 children were enrolled, with 771 included in the final analysis. Of the 771 children included in the analysis, 11% were classified with severe dehydration, 45% with some dehydration, and 44% with no dehydration. Both the DHAKA Dehydration Score and DHAKA Dehydration Tree had significant AUCs of 0.79 (95% CI = 0.74, 0.84) and 0.76 (95% CI = 0.71, 0.80), respectively, for the diagnosis of severe dehydration. Additionally, the DHAKA Dehydration Score and DHAKA Dehydration Tree had significant positive likelihood ratios of 2.0 (95% CI = 1.8, 2.3) and 2.5 (95% CI = 2.1, 2.8), respectively, and significant negative likelihood ratios of 0.23 (95% CI = 0.13, 0.40) and 0.28 (95% CI = 0.18, 0.44), respectively, for the diagnosis of severe dehydration. Both models demonstrated 90% agreement between independent raters and good reproducibility using bootstrapping. Conclusion: This study is the first to empirically derive and internally validate accurate and reliable clinical diagnostic models for dehydration in a resource-limited setting. After external validation, frontline providers may use these new tools to better manage acute diarrhea in children. PMID:26374802

Empirically Derived Dehydration Scoring and Decision Tree Models for Children With Diarrhea: Assessment and Internal Validation in a Prospective Cohort Study in Dhaka, Bangladesh.

PubMed

Levine, Adam C; Glavis-Bloom, Justin; Modi, Payal; Nasrin, Sabiha; Rege, Soham; Chu, Chieh; Schmid, Christopher H; Alam, Nur H

2015-08-18

Diarrhea remains one of the most common and most deadly conditions affecting children worldwide. Accurately assessing dehydration status is critical to determining treatment course, yet no clinical diagnostic models for dehydration have been empirically derived and validated for use in resource-limited settings. In the Dehydration: Assessing Kids Accurately (DHAKA) prospective cohort study, a random sample of children under 5 with acute diarrhea was enrolled between February and June 2014 in Bangladesh. Local nurses assessed children for clinical signs of dehydration on arrival, and then serial weights were obtained as subjects were rehydrated. For each child, the percent weight change with rehydration was used to classify subjects with severe dehydration (>9% weight change), some dehydration (3-9%), or no dehydration (<3%). Clinical variables were then entered into logistic regression and recursive partitioning models to develop the DHAKA Dehydration Score and DHAKA Dehydration Tree, respectively. Models were assessed for their accuracy using the area under their receiver operating characteristic curve (AUC) and for their reliability through repeat clinical exams. Bootstrapping was used to internally validate the models. A total of 850 children were enrolled, with 771 included in the final analysis. Of the 771 children included in the analysis, 11% were classified with severe dehydration, 45% with some dehydration, and 44% with no dehydration. Both the DHAKA Dehydration Score and DHAKA Dehydration Tree had significant AUCs of 0.79 (95% CI = 0.74, 0.84) and 0.76 (95% CI = 0.71, 0.80), respectively, for the diagnosis of severe dehydration. Additionally, the DHAKA Dehydration Score and DHAKA Dehydration Tree had significant positive likelihood ratios of 2.0 (95% CI = 1.8, 2.3) and 2.5 (95% CI = 2.1, 2.8), respectively, and significant negative likelihood ratios of 0.23 (95% CI = 0.13, 0.40) and 0.28 (95% CI = 0.18, 0.44), respectively, for the diagnosis of severe dehydration. Both models demonstrated 90% agreement between independent raters and good reproducibility using bootstrapping. This study is the first to empirically derive and internally validate accurate and reliable clinical diagnostic models for dehydration in a resource-limited setting. After external validation, frontline providers may use these new tools to better manage acute diarrhea in children. © Levine et al.

Development and Validation of a Chronic Pancreatitis Prognosis Score in 2 Independent Cohorts.

PubMed

Beyer, Georg; Mahajan, Ujjwal M; Budde, Christoph; Bulla, Thomas J; Kohlmann, Thomas; Kuhlmann, Louise; Schütte, Kerstin; Aghdassi, Ali A; Weber, Eckhard; Weiss, F Ulrich; Drewes, Asbjørn M; Olesen, Søren S; Lerch, Markus M; Mayerle, Julia

2017-12-01

The clinical course of chronic pancreatitis is unpredictable. There is no model to assess disease severity or progression or predict patient outcomes. We performed a prospective study of 91 patients with chronic pancreatitis; data were collected from patients seen at academic centers in Europe from January 2011 through April 2014. We analyzed correlations between clinical, laboratory, and imaging data with number of hospital readmissions and in-hospital days over the next 12 months; the parameters with the highest degree of correlation were used to develop a 3-stage chronic pancreatitis prognosis score (COPPS). The predictive strength was validated in 129 independent subjects identified from 2 prospective databases. The mean number of hospital admissions was 1.9 (95% confidence interval [CI], 1.39-2.44) and 15.2 for hospital days (95% CI, 10.76-19.71) for the development cohort and 10.9 for the validation cohort (95% CI, 7.54-14.30) (P = .08). Based on bivariate correlations, pain (numeric rating scale), level of glycated hemoglobin A1c, level of C-reactive protein, body mass index, and platelet count were used to develop the COPPS system. The patients' median COPPS was 8.9 points (range, 5-14). The system accurately discriminated stages of disease severity (low to high): A (5-6 points), B (7-9), and C (10-15). In Pearson correlation analysis of the development cohort, the COPPS correlated with hospital admissions (0.39; P < .01) and number of hospital days (0.33; P < .01). The correlation was validated in the validation set (Pearson correlation values of 0.36 and 0.44; P < .01). COPPS did not correlate with results from the Cambridge classification system. We developed and validated an easy to use dynamic multivariate scoring system, similar to the Child-Pugh-Score for liver cirrhosis. The COPPS allows objective monitoring of patients with chronic pancreatitis, determining risk for readmission to hospital and potential length of hospital stay. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Targeting of Gold Deposits in Amazonian Exploration Frontiers using Knowledge- and Data-Driven Spatial Modeling of Geophysical, Geochemical, and Geological Data

NASA Astrophysics Data System (ADS)

Magalhães, Lucíola Alves; Souza Filho, Carlos Roberto

2012-03-01

This paper reports the application of weights-of-evidence, artificial neural networks, and fuzzy logic spatial modeling techniques to generate prospectivity maps for gold mineralization in the neighborhood of the Amapari Au mine, Brazil. The study area comprises one of the last Brazilian mineral exploration frontiers. The Amapari mine is located in the Maroni-Itaicaiúnas Province, which regionally hosts important gold, iron, manganese, chromite, diamond, bauxite, kaolinite, and cassiterite deposits. The Amapari Au mine is characterized as of the orogenic gold deposit type. The highest gold grades are associated with highly deformed rocks and are concentrated in sulfide-rich veins mainly composed of pyrrhotite. The data used for the generation of gold prospectivity models include aerogeophysical and geological maps as well as the gold content of stream sediment samples. The prospectivity maps provided by these three methods showed that the Amapari mine stands out as an area of high potential for gold mineralization. The prospectivity maps also highlight new targets for gold exploration. These new targets were validated by means of detailed maps of gold geochemical anomalies in soil and by fieldwork. The identified target areas exhibit good spatial coincidence with the main soil geochemical anomalies and prospects, thus demonstrating that the delineation of exploration targets by analysis and integration of indirect datasets in a geographic information system (GIS) is consistent with direct prospecting. Considering that work of this nature has never been developed in the Amazonian region, this is an important example of the applicability and functionality of geophysical data and prospectivity analysis in regions where geologic and metallogenetic information is scarce.

Genetic markers enhance coronary risk prediction in men: the MORGAM prospective cohorts.

PubMed

Hughes, Maria F; Saarela, Olli; Stritzke, Jan; Kee, Frank; Silander, Kaisa; Klopp, Norman; Kontto, Jukka; Karvanen, Juha; Willenborg, Christina; Salomaa, Veikko; Virtamo, Jarmo; Amouyel, Phillippe; Arveiler, Dominique; Ferrières, Jean; Wiklund, Per-Gunner; Baumert, Jens; Thorand, Barbara; Diemert, Patrick; Trégouët, David-Alexandre; Hengstenberg, Christian; Peters, Annette; Evans, Alun; Koenig, Wolfgang; Erdmann, Jeanette; Samani, Nilesh J; Kuulasmaa, Kari; Schunkert, Heribert

2012-01-01

More accurate coronary heart disease (CHD) prediction, specifically in middle-aged men, is needed to reduce the burden of disease more effectively. We hypothesised that a multilocus genetic risk score could refine CHD prediction beyond classic risk scores and obtain more precise risk estimates using a prospective cohort design. Using data from nine prospective European cohorts, including 26,221 men, we selected in a case-cohort setting 4,818 healthy men at baseline, and used Cox proportional hazards models to examine associations between CHD and risk scores based on genetic variants representing 13 genomic regions. Over follow-up (range: 5-18 years), 1,736 incident CHD events occurred. Genetic risk scores were validated in men with at least 10 years of follow-up (632 cases, 1361 non-cases). Genetic risk score 1 (GRS1) combined 11 SNPs and two haplotypes, with effect estimates from previous genome-wide association studies. GRS2 combined 11 SNPs plus 4 SNPs from the haplotypes with coefficients estimated from these prospective cohorts using 10-fold cross-validation. Scores were added to a model adjusted for classic risk factors comprising the Framingham risk score and 10-year risks were derived. Both scores improved net reclassification (NRI) over the Framingham score (7.5%, p = 0.017 for GRS1, 6.5%, p = 0.044 for GRS2) but GRS2 also improved discrimination (c-index improvement 1.11%, p = 0.048). Subgroup analysis on men aged 50-59 (436 cases, 603 non-cases) improved net reclassification for GRS1 (13.8%) and GRS2 (12.5%). Net reclassification improvement remained significant for both scores when family history of CHD was added to the baseline model for this male subgroup improving prediction of early onset CHD events. Genetic risk scores add precision to risk estimates for CHD and improve prediction beyond classic risk factors, particularly for middle aged men.

Dietary acrylamide intake and risk of breast cancer: The Japan Public Health Center-based Prospective Study.

PubMed

Kotemori, Ayaka; Ishihara, Junko; Zha, Ling; Liu, Rong; Sawada, Norie; Iwasaki, Motoki; Sobue, Tomotaka; Tsugane, Shoichiro

2018-03-01

Acrylamide forms during cooking and is classified as a probable carcinogen in humans, mandating the need for epidemiological studies of dietary acrylamide and cancers. However, the risk of dietary acrylamide exposure to breast cancer in Japanese women has not been assessed. We investigated the association between dietary acrylamide intake and risk of breast cancer in the Japan Public Health Center-based Prospective Study. The present study included 48 910 women aged 45-74 years who responded to a 5-year follow-up survey questionnaire. Dietary acrylamide intake was assessed using a validated food frequency questionnaire. Cox proportional hazards regression models were used to estimate hazard ratios and 95% confidence intervals. During an average of 15.4 years of follow up, 792 breast cancers were diagnosed. Energy-adjusted dietary acrylamide intake was not associated with the risk of breast cancer (adjusted hazard ratio for highest versus lowest tertile = .95, 95% confidence intervals: 0.79-1.14, P-trend = .58). Further, no significant associations were observed when stratified analyses were conducted by smoking status, coffee consumption, alcohol consumption, body mass index, menopausal status, estrogen receptor status, and progesterone receptor status. In conclusion, dietary acrylamide intake was not associated with the risk of breast cancer in this population-based prospective cohort study of Japanese women. © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Development and validation of electronic surveillance tool for acute kidney injury: A retrospective analysis.

PubMed

Ahmed, Adil; Vairavan, Srinivasan; Akhoundi, Abbasali; Wilson, Gregory; Chiofolo, Caitlyn; Chbat, Nicolas; Cartin-Ceba, Rodrigo; Li, Guangxi; Kashani, Kianoush

2015-10-01

Timely detection of acute kidney injury (AKI) facilitates prevention of its progress and potentially therapeutic interventions. The study objective is to develop and validate an electronic surveillance tool (AKI sniffer) to detect AKI in 2 independent retrospective cohorts of intensive care unit (ICU) patients. The primary aim is to compare the sensitivity, specificity, and positive and negative predictive values of AKI sniffer performance against a reference standard. This study is conducted in the ICUs of a tertiary care center. The derivation cohort study subjects were Olmsted County, MN, residents admitted to all Mayo Clinic ICUs from July 1, 2010, through December 31, 2010, and the validation cohort study subjects were all patients admitted to a Mayo Clinic, Rochester, campus medical/surgical ICU on January 12, 2010, through March 23, 2010. All included records were reviewed by 2 independent investigators who adjudicated AKI using the Acute Kidney Injury Network criteria; disagreements were resolved by a third reviewer. This constituted the reference standard. An electronic algorithm was developed; its precision and reliability were assessed in comparison with the reference standard in 2 separate cohorts, derivation and validation. Of 1466 screened patients, a total of 944 patients were included in the study: 482 for derivation and 462 for validation. Compared with the reference standard in the validation cohort, the sensitivity and specificity of the AKI sniffer were 88% and 96%, respectively. The Cohen κ (95% confidence interval) agreement between the electronic and the reference standard was 0.84 (0.78-0.89) and 0.85 (0.80-0.90) in the derivation and validation cohorts. Acute kidney injury can reliably and accurately be detected electronically in ICU patients. The presented method is applicable for both clinical (decision support) and research (enrollment for clinical trials) settings. Prospective validation is required. Copyright © 2015 Elsevier Inc. All rights reserved.

Further evaluation of the EORTC QLQ-C30 psychometric properties in a large Brazilian cancer patient cohort as a function of their educational status.

PubMed

Paiva, Carlos Eduardo; Carneseca, Estela Cristina; Barroso, Eliane Marçon; de Camargos, Mayara Goulart; Alfano, Ana Camila Callado; Rugno, Fernanda Capella; Paiva, Bianca Sakamoto Ribeiro

2014-08-01

The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is considered a valid instrument for use in Brazil. However, the previous Brazilian validation study included only 30 lung cancer patients and only measured test-retest reliability. The aim of this study was to evaluate the psychometric properties of the EORTC QLQ-C30 in a sample of cancer patients at different educational levels who completed the instrument administered by an interviewer. Data from six prospective studies conducted by the same group of researchers were combined in this study (N = 986). Reliability was assessed using Cronbach's alpha coefficient, all values of which were >0.7, with the exception of cognitive functioning, social functioning, and nausea and vomiting (α = 0.57, α = 0.69, and α = 0.68, respectively). In multi-trait scaling analysis, convergent and divergent validity were considered adequate (validity indices were 91.6 and 97.4%). In general, moderate to strong correlations were found between the subscales of the EORTC QLQ-C30 and its respective dimensions from the WHOQOL-bref, the hospital anxiety and depression scale, and the Edmonton Symptom Assessment System (ESAS) instruments. In addition, the EORTC QLQ-C30 was able to differentiate groups of patients with distinct performance statuses and types of treatment (known-group validation). Statistical analyses were also performed on educational status, yielding similar results. Detailed psychometric property data using the EORTC QLQ-C30 in Brazil are added by this study. In addition, we demonstrated that this instrument is in general reliable and valid regardless of the patient educational level.

Hope Modified the Association between Distress and Incidence of Self-Perceived Medical Errors among Practicing Physicians: Prospective Cohort Study

PubMed Central

Hayashino, Yasuaki; Utsugi-Ozaki, Makiko; Feldman, Mitchell D.; Fukuhara, Shunichi

2012-01-01

The presence of hope has been found to influence an individual's ability to cope with stressful situations. The objective of this study is to evaluate the relationship between medical errors, hope and burnout among practicing physicians using validated metrics. Prospective cohort study was conducted among hospital based physicians practicing in Japan (N = 836). Measures included the validated Burnout Scale, self-assessment of medical errors and Herth Hope Index (HHI). The main outcome measure was the frequency of self-perceived medical errors, and Poisson regression analysis was used to evaluate the association between hope and medical error. A total of 361 errors were reported in 836 physician-years. We observed a significant association between hope and self-report of medical errors. Compared with the lowest tertile category of HHI, incidence rate ratios (IRRs) of self-perceived medical errors of physicians in the highest category were 0.44 (95%CI, 0.34 to 0.58) and 0.54 (95%CI, 0.42 to 0.70) respectively, for the 2nd and 3rd tertile. In stratified analysis by hope score, among physicians with a low hope score, those who experienced higher burnout reported higher incidence of errors; physicians with high hope scores did not report high incidences of errors, even if they experienced high burnout. Self-perceived medical errors showed a strong association with physicians' hope, and hope modified the association between physicians' burnout and self-perceived medical errors. PMID:22530055

Association between background exposure to organochlorine pesticides and the risk of cognitive impairment: A prospective study that accounts for weight change.

PubMed

Lee, Duk-Hee; Lind, P Monica; Jacobs, David R; Salihovic, Samira; van Bavel, Bert; Lind, Lars

2016-01-01

Background exposure to organochlorine (OC) pesticides was recently linked to cognitive impairment and dementia in cross-sectional and case-control studies. This prospective study was performed to evaluate if OC pesticides at baseline are associated with the future risk of cognitive impairment in elderly, with particular focus on weight change. Plasma concentrations of 3 OC pesticides (p,p'-DDE, trans-nonachlor, and hexachlorobenzene) were measured among 989 men and women aged 70years in the Prospective Investigation of the Vasculature in Uppsala Seniors (PIVUS). Cognitive impairment was validated by reviewing medical records. During the ten year follow-up, cognitive impairment was developed in 75 subjects. When weight change from age 70 to 75 was considered in analyses, elderly with incident cases before age 75 were excluded to keep the prospective perspective, leaving 795 study subjects and 44 incident cases. The summary measure of 3 OC pesticides predicted the development of cognitive impairment after adjusting for covariates, including weight change. Compared to subjects with OC pesticides <25th percentile, adjusted hazard ratios (HRs) in those with 25th-<75th and ≥75th percentiles were 3.5 (95% confidence interval: 1.5-8.5) and 3.2 (1.1-7.6), respectively (Ptrend=0.04). Among 506 subjects who maintained or gained body weight, adjusted HRs were 6.9 and 11.6 (1.4-92.6) among the elderly in the 25th-<75th and ≥75th percentiles compared to <25th percentile (Ptrend<0.01). This prospective study demonstrates that background exposure to OC pesticides are linked to the risk of developing cognitive impairment in elderly. The role of the chronic exposure to low dose OC pesticides in the development of dementia should be further evaluated in other populations. Copyright © 2016 Elsevier Ltd. All rights reserved.

How Many Batches Are Needed for Process Validation under the New FDA Guidance?

PubMed

Yang, Harry

2013-01-01

The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and they highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance. The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and THEY highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance.

Diagnosing breast cancer using Raman spectroscopy: prospective analysis

NASA Astrophysics Data System (ADS)

Haka, Abigail S.; Volynskaya, Zoya; Gardecki, Joseph A.; Nazemi, Jon; Shenk, Robert; Wang, Nancy; Dasari, Ramachandra R.; Fitzmaurice, Maryann; Feld, Michael S.

2009-09-01

We present the first prospective test of Raman spectroscopy in diagnosing normal, benign, and malignant human breast tissues. Prospective testing of spectral diagnostic algorithms allows clinicians to accurately assess the diagnostic information contained in, and any bias of, the spectroscopic measurement. In previous work, we developed an accurate, internally validated algorithm for breast cancer diagnosis based on analysis of Raman spectra acquired from fresh-frozen in vitro tissue samples. We currently evaluate the performance of this algorithm prospectively on a large ex vivo clinical data set that closely mimics the in vivo environment. Spectroscopic data were collected from freshly excised surgical specimens, and 129 tissue sites from 21 patients were examined. Prospective application of the algorithm to the clinical data set resulted in a sensitivity of 83%, a specificity of 93%, a positive predictive value of 36%, and a negative predictive value of 99% for distinguishing cancerous from normal and benign tissues. The performance of the algorithm in different patient populations is discussed. Sources of bias in the in vitro calibration and ex vivo prospective data sets, including disease prevalence and disease spectrum, are examined and analytical methods for comparison provided.

An Innovative Model for Naloxone Use Within an OTP Setting: A Prospective Cohort Study

PubMed Central

Katzman, Joanna G.; Takeda, Mikiko Y.; Bhatt, Snehal R.; Moya Balasch, Monica; Greenberg, Nina; Yonas, Howard

2018-01-01

Objectives: Unintentional opioid overdose deaths are a public health crisis, and naloxone is the most effective harm reduction tool to curb many of these deaths. There is growing evidence that take-home naloxone can prevent opioid overdose in targeted populations. The goal of this study is to measure the opioid overdose reversal rate with take-home naloxone among participants with a diagnosis of opioid use disorder (OUD) in an opioid treatment program (OTP) setting. Methods: Patients enrolled in an outpatient OTP program were eligible for this prospective cohort study between April 4, 2016 and July 4, 2016. Two hundred forty-four study participants received overdose education, instruction on how to use naloxone, and were provided with 2 doses of a take-home naloxone auto-injector kit. They were subsequently followed for 3 months. Results: Thirty-one study participants reported overdose reversals using naloxone auto-injector kits on 38 community members. All overdose reversals were heroin-related. Eighty-seven per cent of the community members reversed with naloxone were friends or relatives of the study participants. Conclusions: This study validates that naloxone is not commonly used on the index study participant, but is often used on a secondary target among people who inject drugs. The large number of overdose reversals reported in this prospective study suggests that this novel model for naloxone use may be replicated at other OTP settings to reduce opioid overdose deaths. PMID:29227321

Neonatal intensive care unit: predictive models for length of stay.

PubMed

Bender, G J; Koestler, D; Ombao, H; McCourt, M; Alskinis, B; Rubin, L P; Padbury, J F

2013-02-01

Hospital length of stay (LOS) is important to administrators and families of neonates admitted to the neonatal intensive care unit (NICU). A prediction model for NICU LOS was developed using predictors birth weight, gestational age and two severity of illness tools, the score for neonatal acute physiology, perinatal extension (SNAPPE) and the morbidity assessment index for newborns (MAIN). Consecutive admissions (n=293) to a New England regional level III NICU were retrospectively collected. Multiple predictive models were compared for complexity and goodness-of-fit, coefficient of determination (R (2)) and predictive error. The optimal model was validated prospectively with consecutive admissions (n=615). Observed and expected LOS was compared. The MAIN models had best Akaike's information criterion, highest R (2) (0.786) and lowest predictive error. The best SNAPPE model underestimated LOS, with substantial variability, yet was fairly well calibrated by birthweight category. LOS was longer in the prospective cohort than the retrospective cohort, without differences in birth weight, gestational age, MAIN or SNAPPE. LOS prediction is improved by accounting for severity of illness in the first week of life, beyond factors known at birth. Prospective validation of both MAIN and SNAPPE models is warranted.

Psychometric properties of the 30-m walking test in patients with degenerative cervical myelopathy: results from two prospective multicenter cohort studies.

PubMed

Bohm, Parker E; Fehlings, Michael G; Kopjar, Branko; Tetreault, Lindsay A; Vaccaro, Alexander R; Anderson, Karen K; Arnold, Paul M

2017-02-01

The timed 30-m walking test (30MWT) is used in clinical practice and in research to objectively quantify gait impairment. The psychometric properties of 30MWT have not yet been rigorously evaluated. This study aimed to determine test-retest reliability, divergent and convergent validity, and responsiveness to change of the 30MWT in patients with degenerative cervical myelopathy (DCM). A retrospective observational study was carried out. The sample consisted of patients with symptomatic DCM enrolled in the AOSpine North America or AOSpine International cervical spondylotic myelopathy studies at 26 sites. Modified Japanese Orthopaedic Association scale (mJOA), Nurick scale, 30MWT, Neck Disability Index (NDI), and Short-Form-36 (SF-36v2) physical component score (PCS) and mental component score (MCS) were the outcome measures. Data from two prospective multicenter cohort myelopathy studies were merged. Each patient was evaluated at baseline and 6 months postoperatively. Of 757 total patients, 682 (90.09%) attempted to perform the 30MWT at baseline. Of these 682 patients, 602 (88.12%) performed the 30MWT at baseline. One patient was excluded, leaving601 in the analysis. At baseline, 81 of 682 (11.88%) patients were unable to perform the test, and their mJOA, NDI, and SF-36v2 PCS scores were lower compared with those who performed the test at baseline. In patients who performed the 30MWT at baseline, there was very high correlation among the three baseline 30MWT measurements (r=0.9569-0.9919). The 30MWT demonstrated good convergent and divergent validity. It was moderately correlated with the Nurick (r=0.4932), mJOA (r=-0.4424), and SF-36v2 PCS (r=-0.3537) (convergent validity) and poorly correlated with the NDI (r=0.2107) and SF-36v2 MCS (r=-0.1984) (divergent validity). Overall, the 30MWT was not responsive to change (standardized response mean [SRM]=0.30). However, for patients who had a baseline time above the median value of 29 seconds, the SRM was 0.45. The 30MWT shows high test-retest reliability and good divergent and convergent validity. It is responsive to change only in patients with more severe myelopathy. The 30MWT is a simple, quick, and affordable test, and should be used as an ancillary test to evaluate gait parameters in patients with DCM. Copyright © 2016 Elsevier Inc. All rights reserved.

Risk score for identifying adults with CSF pleocytosis and negative CSF Gram stain at low risk for an urgent treatable cause.

PubMed

Hasbun, Rodrigo; Bijlsma, Merijn; Brouwer, Matthijs C; Khoury, Nabil; Hadi, Christiane M; van der Ende, Arie; Wootton, Susan H; Salazar, Lucrecia; Hossain, Md Monir; Beilke, Mark; van de Beek, Diederik

2013-08-01

We aimed to derive and validate a risk score that identifies adults with cerebrospinal fluid (CSF) pleocytosis and a negative CSF Gram stain at low risk for an urgent treatable cause. Patients with CSF pleocytosis and a negative CSF Gram stain were stratified into a prospective derivation (n = 193) and a retrospective validation (n = 567) cohort. Clinically related baseline characteristics were grouped into three composite variables, each independently associated with a set of predefined urgent treatable causes. We subsequently derived a risk score classifying patients into low (0 composite variables present) or high (≥ 1 composite variables present) risk for an urgent treatable cause. The sensitivity of the risk score was determined in the validation cohort and in a prospective case series of 214 adults with CSF-culture proven bacterial meningitis, CSF pleocytosis and a negative Gram stain. A total of 41 of 193 patients (21%) in the derivation cohort and 71 of 567 (13%) in the validation cohort had an urgent treatable cause. Sensitivity of the dichotomized risk score to detect an urgent treatable cause was 100.0% (95% CI 93.9-100.0%) in the validation cohort and 100.0% (95% CI 97.8-100.0%) in bacterial meningitis patients. The risk score can be used to identify adults with CSF pleocytosis and a negative CSF Gram stain at low risk for an urgent treatable cause. Copyright © 2013 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

RISK SCORE FOR IDENTIFYING ADULTS WITH CSF PLEOCYTOSIS AND NEGATIVE CSF GRAM STAIN AT LOW RISK FOR AN URGENT TREATABLE CAUSE

PubMed Central

Hasbun, Rodrigo; Bijlsma, Merijn; Brouwer, Matthijs C; Khoury, Nabil; Hadi, Christiane M; van der Ende, Arie; Wootton, Susan H.; Salazar, Lucrecia; Hossain, Md Monir; Beilke, Mark; van de Beek, Diederik

2013-01-01

Background We aimed to derive and validate a risk score that identifies adults with cerebrospinal fluid (CSF) pleocytosis and a negative CSF Gram stain at low risk for an urgent treatable cause. Methods Patients with CSF pleocytosis and a negative CSF Gram stain were stratified into a prospective derivation (n=193) and a retrospective validation (n=567) cohort. Clinically related baseline characteristics were grouped into three composite variables, each independently associated with a set of predefined urgent treatable causes. We subsequently derived a risk score classifying patients into low (0 composite variables present) or high ( ≥ 1 composite variables present) risk for an urgent treatable cause. The sensitivity of the risk score was determined in the validation cohort and in a prospective case series of 214 adults with CSF-culture proven bacterial meningitis, CSF pleocytosis and a negative Gram stain. Findings A total of 41 of 193 patients (21%) in the derivation cohort and 71 of 567 (13%) in the validation cohort had an urgent treatable cause. Sensitivity of the dichotomized risk score to detect an urgent treatable cause was 100.0% (95%CI 93.9-100.0%) in the validation cohort and 100.0% (95%CI 97.8-100.0%) in bacterial meningitis patients. Interpretation The risk score can be used to identify adults with CSF pleocytosis and a negative CSF Gram stain at low risk for an urgent treatable cause. PMID:23619080

Gold potential in the Dalradian rocks of NW Northern Ireland: GIS-based prospectivity analysis using Tellus data

NASA Astrophysics Data System (ADS)

Lusty, P. A. J.; McDonnell, P. M.; Gunn, A. G.; Chacksfield, B. C.; Cooper, M.

2009-04-01

Geographic Information Systems (GIS) are essential tools for the management and integration of the large amounts of multivariate spatial data used in mineral exploration. Prospectivity analysis combines these datasets, in the context of a mineral deposit model, to produce a map showing the distribution of potential for a particular type of mineral deposit. In this example Arc-Spatial Data Modeller software has been used to analyse the prospectivity for orogenic vein gold mineralisation in the Dalradian rocks of north-western Northern Ireland. A knowledge-driven (fuzzy logic) approach was used because of the small number of gold deposits within the area. Fuzzy logic is used in situations where information is inexact and the use of classical set theory is inappropriate. Fuzzy logic allows assignment of weightings to exploration data on a continuous scale from 1 (full membership) to 0 (full non-membership). This allows a level of uncertainty or 'fuzziness' to be incorporated into the modelling. The key stages of prospectivity analysis are: (1) analysis of the deposit model to determine key exploration indicators; (2) data processing, interpretation and analysis to extract key indicators; (3) assignment of weightings, zones and styles of influence to key indicators; and (4) calculation of prospectivity. This research is based largely on new geochemical and geophysical data resulting from the Tellus Project in Northern Ireland. The Tellus Project involved geochemical and airborne geophysical surveys over the whole of Northern Ireland carried out between 2004-6 with funding from the Government of Northern Ireland. The study area (3074 km2) is underlain mainly by Neoproterozoic rocks of the Dalradian Supergroup (ca. 590 Ma) which form part of the Caledonide orogenic belt. The Dalradian Supergroup comprises a thick succession of semi-pelites, psammites and pelites, with graphitic pelite horizons that host much of the known gold mineralisation. In the Sperrin Mountains two advanced gold projects, Curraghinalt and Golan Burn, and an operating mine, Omagh (Cavanacaw), are hosted by Dalradian rocks. The Dalradian rocks of Northern Ireland were extensively deformed during the Grampian Orogeny and at least four phases of deformation are recognised. On a deposit scale distinct differences are observed between Curraghinalt and Cavanacaw including orientation of principal structures, mineralogy and geochemistry. The mineral prospectivity analysis integrated a range of datasets including: 1:250 000 scale geological mapping, mineral occurrences, fault vectors, Tellus drainage geochemistry and geophysics. In order to assess the differences between the Curraghinalt and Cavanacaw mineral deposit models separate prospectivity models were parameterised. The key differences between the two models relate to the weightings attached to the structural vectors and the significance given to particular chemical elements in the drainage geochemical dataset. The prospectivity analysis identified several areas prospective for orogenic-style gold mineralisation. Many of the prospective zones either coincide with known occurrences of orogenic gold mineralisation or areas considered highly prospective based upon previous work, validating the process and the model results. The use of specific models for the Curraghinalt and Cavanacaw deposits has produced significant differences in the location and extent of the target areas which provide a basis for focusing exploration for orogenic gold deposits in this region. Detailed examination of all available data and ground truthing is required in order to validate these targets. In addition to delineating new areas favourable for gold mineralisation the prospectivity mapping has provided new insight into possible regional controls on the location of mineralisation and into the geology of this area. Please fill in your abstract text.

Simulated training in colonoscopic stenting of colonic strictures: validation of a cadaver model.

PubMed

Iordache, F; Bucobo, J C; Devlin, D; You, K; Bergamaschi, R

2015-07-01

There are currently no available simulation models for training in colonoscopic stent deployment. The aim of this study was to validate a cadaver model for simulation training in colonoscopy with stent deployment for colonic strictures. This was a prospective study enrolling surgeons at a single institution. Participants performed colonoscopic stenting on a cadaver model. Their performance was assessed by two independent observers. Measurements were performed for quantitative analysis (time to identify stenosis, time for deployment, accuracy) and a weighted score was devised for assessment. The Mann-Whitney U-test and Student's t-test were used for nonparametric and parametric data, respectively. Cohen's kappa coefficient was used for reliability. Twenty participants performed a colonoscopy with deployment of a self-expandable metallic stent in two cadavers (groups A and B) with 20 strictures overall. The median time was 206 s. The model was able to differentiate between experts and novices (P = 0. 013). The results showed a good consensus estimate of reliability, with kappa = 0.571 (P < 0.0001). The cadaver model described in this study has content, construct and concurrent validity for simulation training in colonoscopic deployment of self-expandable stents for colonic strictures. Further studies are needed to evaluate the predictive validity of this model in terms of skill transfer to clinical practice. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

Exposure to Radiofrequency Electromagnetic Fields and Sleep Quality: A Prospective Cohort Study

PubMed Central

Mohler, Evelyn; Frei, Patrizia; Fröhlich, Jürg; Braun-Fahrländer, Charlotte; Röösli, Martin

2012-01-01

Background There is persistent public concern about sleep disturbances due to radiofrequency electromagnetic field (RF-EMF) exposure. The aim of this prospective cohort study was to investigate whether sleep quality is affected by mobile phone use or by other RF-EMF sources in the everyday environment. Methods We conducted a prospective cohort study with 955 study participants aged between 30 and 60 years. Sleep quality and daytime sleepiness was assessed by means of standardized questionnaires in May 2008 (baseline) and May 2009 (follow-up). We also asked about mobile and cordless phone use and asked study participants for consent to obtain their mobile phone connection data from the mobile phone operators. Exposure to environmental RF-EMF was computed for each study participant using a previously developed and validated prediction model. In a nested sample of 119 study participants, RF-EMF exposure was measured in the bedroom and data on sleep behavior was collected by means of actigraphy during two weeks. Data were analyzed using multivariable regression models adjusted for relevant confounders. Results In the longitudinal analyses neither operator-recorded nor self-reported mobile phone use was associated with sleep disturbances or daytime sleepiness. Also, exposure to environmental RF-EMF did not affect self-reported sleep quality. The results from the longitudinal analyses were confirmed in the nested sleep study with objectively recorded exposure and measured sleep behavior data. Conclusions We did not find evidence for adverse effects on sleep quality from RF-EMF exposure in our everyday environment. PMID:22624036

Construction, internal validation and implementation in a mobile application of a scoring system to predict nonadherence to proton pump inhibitors.

PubMed

Mares-García, Emma; Palazón-Bru, Antonio; Folgado-de la Rosa, David Manuel; Pereira-Expósito, Avelino; Martínez-Martín, Álvaro; Cortés-Castell, Ernesto; Gil-Guillén, Vicente Francisco

2017-01-01

Other studies have assessed nonadherence to proton pump inhibitors (PPIs), but none has developed a screening test for its detection. To construct and internally validate a predictive model for nonadherence to PPIs. This prospective observational study with a one-month follow-up was carried out in 2013 in Spain, and included 302 patients with a prescription for PPIs. The primary variable was nonadherence to PPIs (pill count). Secondary variables were gender, age, antidepressants, type of PPI, non-guideline-recommended prescription (NGRP) of PPIs, and total number of drugs. With the secondary variables, a binary logistic regression model to predict nonadherence was constructed and adapted to a points system. The ROC curve, with its area (AUC), was calculated and the optimal cut-off point was established. The points system was internally validated through 1,000 bootstrap samples and implemented in a mobile application (Android). The points system had three prognostic variables: total number of drugs, NGRP of PPIs, and antidepressants. The AUC was 0.87 (95% CI [0.83-0.91], p  < 0.001). The test yielded a sensitivity of 0.80 (95% CI [0.70-0.87]) and a specificity of 0.82 (95% CI [0.76-0.87]). The three parameters were very similar in the bootstrap validation. A points system to predict nonadherence to PPIs has been constructed, internally validated and implemented in a mobile application. Provided similar results are obtained in external validation studies, we will have a screening tool to detect nonadherence to PPIs.

Emotional and tangible social support in a German population-based sample: Development and validation of the Brief Social Support Scale (BS6).

PubMed

Beutel, Manfred E; Brähler, Elmar; Wiltink, Jörg; Michal, Matthias; Klein, Eva M; Jünger, Claus; Wild, Philipp S; Münzel, Thomas; Blettner, Maria; Lackner, Karl; Nickels, Stefan; Tibubos, Ana N

2017-01-01

Aim of the study was the development and validation of the psychometric properties of a six-item bi-factorial instrument for the assessment of social support (emotional and tangible support) with a population-based sample. A cross-sectional data set of N = 15,010 participants enrolled in the Gutenberg Health Study (GHS) in 2007-2012 was divided in two sub-samples. The GHS is a population-based, prospective, observational single-center cohort study in the Rhein-Main-Region in western Mid-Germany. The first sub-sample was used for scale development by performing an exploratory factor analysis. In order to test construct validity, confirmatory factor analyses were run to compare the extracted bi-factorial model with the one-factor solution. Reliability of the scales was indicated by calculating internal consistency. External validity was tested by investigating demographic characteristics health behavior, and distress using analysis of variance, Spearman and Pearson correlation analysis, and logistic regression analysis. Based on an exploratory factor analysis, a set of six items was extracted representing two independent factors. The two-factor structure of the Brief Social Support Scale (BS6) was confirmed by the results of the confirmatory factor analyses. Fit indices of the bi-factorial model were good and better compared to the one-factor solution. External validity was demonstrated for the BS6. The BS6 is a reliable and valid short scale that can be applied in social surveys due to its brevity to assess emotional and practical dimensions of social support.

The Chinese version of the Severe Respiratory Insufficiency questionnaire for patients with chronic hypercapnic chronic obstructive pulmonary disease receiving non-invasive positive pressure ventilation.

PubMed

Chen, Rongchang; Guan, Lili; Wu, Weiliang; Yang, Zhicong; Li, Xiaoying; Luo, Qun; Liang, Zhenyu; Wang, Fengyan; Guo, Bingpeng; Huo, Yating; Yang, Yuqiong; Zhou, Luqian

2017-08-28

The Severe Respiratory Insufficiency (SRI) questionnaire is the best assessment tool for health-related quality of life in patients with chronic obstructive pulmonary disease (COPD) receiving non-invasive positive pressure ventilation (NIPPV). This study aimed to translate the SRI Questionnaire into Chinese and to validate it. Prospective validation study. A total of 149 participants with chronic hypercapnic COPD receiving NIPPV completed the study. The SRI questionnaire was translated into Chinese using translation and back-translation. Reliability was gauged using Cronbach's α coefficient. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to assess construct validity. Content validity was confirmed by evaluating the relationship between the score of each item and the total score of the relevant subscale. Cronbach's α coefficients for each subscale and summary scale were above 0.7. Using EFA, one factor was extracted from the anxiety and summary scales and two factors were extracted from the remaining six subscales. Based on the EFA results, subsequent CFA revealed a good model fit for each subscale, but the extracted factors of each subscale were correlated. Content validity was confirmed by the good relationship between the score of each item and the total score of the relevant subscale. The Chinese version of the SRI questionnaire is valid and reliable for patients with chronic hypercapnic COPD receiving NIPPV in China. NCT02499718. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Psychometric Evaluation of the PSQI in U.S. College Students

PubMed Central

Dietch, Jessica R.; Taylor, Daniel J.; Sethi, Kevin; Kelly, Kimberly; Bramoweth, Adam D.; Roane, Brandy M.

2016-01-01

Study Objectives: Examine the psychometric properties of the PSQI in two U.S. college samples. Methods: Study I assessed convergent and divergent validity in 866 undergraduates who completed a sleep diary, PSQI, and other sleep and psychosocial measures. Study II assessed PSQI insomnia diagnostic accuracy in a separate sample of 147 healthy undergraduates with and without insomnia. Results: The PSQI global score had only moderate convergent validity with sleep diary sleep efficiency (prospective global measure of sleep continuity; r = 0.53), the Insomnia Severity Index (r = 0.63), and fatigue (r = 0.44). The PSQI global score demonstrated good divergent validity with measures of excessive daytime sleepiness (r = 0.18), circadian preference (r = −0.08), alcohol (r = 0.08) and marijuana (r = 0.05) abuse scales, and poor divergent validity with depression (r = 0.48), anxiety (r = 0.40), and perceived stress (r = 0.33). Examination of other analogous PSQI and sleep diary components showed low to moderate convergent validity: sleep latency (r = 0.70), wake after sleep onset (r = 0.37), sleep duration (r = 0.51), and sleep efficiency (r = −0.32). Diagnostic accuracy of the PSQI to detect insomnia was very high (area under the curve = 0.999). Sensitivity and specificity were maximized at a cutoff of 6. Conclusions: The PSQI demonstrated moderate convergent validity compared to measures of insomnia and fatigue and good divergent validity with measures of daytime sleepiness, circadian phase preference, and alcohol and marijuana use. The PSQI demonstrated considerable overlap with depression, anxiety, and perceived stress. Therefore, caution should be used with interpretation. Citation: Dietch JR, Taylor DJ, Sethi K, Kelly K, Bramoweth AD, Roane BM. Psychometric evaluation of the PSQI in U.S. college students. J Clin Sleep Med 2016;12(8):1121–1129. PMID:27166299

Adaptation and validation of the Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) questionnaire for use in patients with osteoarthritis in Spain.

PubMed

Gonzalez Sáenz de Tejada, Marta; Escobar, Antonio; Herdman, Michael; Herrera, Carmen; García, Lidia; Sarasqueta, Cristina

2011-12-01

This study aims to adapt and validate the Spanish version of the Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) questionnaire. The OAKHQOL was adapted into Spanish using a forward-backward translation methodology. The Spanish version was then validated in a prospective, mixed-design study of 759 patients with hip or knee osteoarthritis (OA). Patients completed the OAKHQOL, Short Form 36 (SF-36), Western Ontario and McMaster Universities Osteoarthritis Index, and the EQ-5D. The internal consistency was evaluated using Cronbach's alpha. Convergent validity was assessed by examining correlations between the OAKHQOL and other patient-reported instruments; known groups' validity was assessed by determining the capacity of the OAKHQOL to discriminate between patients with different levels of disease severity measured using the Lequesne Index. Test-retest reliability was evaluated by calculating the intraclass correlation coefficient (ICC) for all OAKHQOL domains in 409 stable patients with OA. Responsiveness was evaluated by calculating effect sizes among 129 patients undergoing hip or knee replacement. Cronbach's alpha for the five domains of the OAKHQOL ranged from 0.60 to 0.93 while ICCs ranged from 0.75 to 0.81 for all domains except the two social domains. Statistically significant differences (p < 0.001) were observed between patients with different degrees of disease severity on all domains except "social support". The instrument showed convergent validity among hypothesized domains (p < 0.001). Results of the study supported that the Spanish version OAKHQOL questionnaire was a valid instrument to measure health-related quality of life in patients with OA of the lower limb.

Optimal Decision Stimuli for Risky Choice Experiments: An Adaptive Approach

PubMed Central

Cavagnaro, Daniel R.; Gonzalez, Richard; Myung, Jay I.; Pitt, Mark A.

2014-01-01

Collecting data to discriminate between models of risky choice requires careful selection of decision stimuli. Models of decision making aim to predict decisions across a wide range of possible stimuli, but practical limitations force experimenters to select only a handful of them for actual testing. Some stimuli are more diagnostic between models than others, so the choice of stimuli is critical. This paper provides the theoretical background and a methodological framework for adaptive selection of optimal stimuli for discriminating among models of risky choice. The approach, called Adaptive Design Optimization (ADO), adapts the stimulus in each experimental trial based on the results of the preceding trials. We demonstrate the validity of the approach with simulation studies aiming to discriminate Expected Utility, Weighted Expected Utility, Original Prospect Theory, and Cumulative Prospect Theory models. PMID:24532856

Relative validity of an FFQ to estimate daily food and nutrient intakes for Chilean adults.

PubMed

Dehghan, Mahshid; Martinez, Solange; Zhang, Xiaohe; Seron, Pamela; Lanas, Fernando; Islam, Shofiqul; Merchant, Anwar T

2013-10-01

FFQ are commonly used to rank individuals by their food and nutrient intakes in large epidemiological studies. The purpose of the present study was to develop and validate an FFQ to rank individuals participating in an ongoing Prospective Urban and Rural Epidemiological (PURE) study in Chile. An FFQ and four 24 h dietary recalls were completed over 1 year. Pearson correlation coefficients, energy-adjusted and de-attenuated correlations and weighted kappa were computed between the dietary recalls and the FFQ. The level of agreement between the two dietary assessment methods was evaluated by Bland-Altman analysis. Temuco, Chile. Overall, 166 women and men enrolled in the present study. One hundred men and women participated in FFQ development and sixty-six individuals participated in FFQ validation. The FFQ consisted of 109 food items. For nutrients, the crude correlation coefficients between the dietary recalls and FFQ varied from 0.14 (protein) to 0.44 (fat). Energy adjustment and de-attenuation improved correlation coefficients and almost all correlation coefficients exceeded 0.40. Similar correlation coefficients were observed for food groups; the highest de-attenuated energy adjusted correlation coefficient was found for margarine and butter (0.75) and the lowest for potatoes (0.12). The FFQ showed moderate to high agreement for most nutrients and food groups, and can be used to rank individuals based on energy, nutrient and food intakes. The validation study was conducted in a unique setting and indicated that the tool is valid for use by adults in Chile.

The international Hip Outcome Tool-33 (iHOT-33): multicenter validation and translation to Spanish.

PubMed

Ruiz-Ibán, Miguel Angel; Seijas, Roberto; Sallent, Andrea; Ares, Oscar; Marín-Peña, Oliver; Muriel, Alfonso; Cuéllar, Ricardo

2015-05-20

The international Hip Outcome Tool-33 (iHOT-33) is a 33-item self administered outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The aim of the present study is to translate and validate the iHOT-33 into Spanish. 97 patients undergoing hip arthroscopy were included in this prospective and multicenter study performed between January 2012 and May 2014. Crosscultural adaptation was used to translate iHOT-33 into Spanish. Patients completed the questionnaire before and after surgery. Feasibility, reliability, internal consistency, construct validity (correlation with Western Ontario and McMaster Universities Osteoarthritis Index), ceiling and floor effects and sensitivity to change were assessed for the present study. Mean age was 48 years old. Feasibility: 41.2 % patients had no blank questions, and 71.3 % of patients had fulfilled all but one or two questions. Reliability: ICC for the global questionnaire was 0.97, showing that the questionnaire is highly reproducible. Internal consistency: Cronbach's alpha was 0.98 for the global questionnaire. Construct validity: there was a high correlation with WOMAC (correlation coefficient >0.5). The Ceiling effect (taking into account the minimum detectable change) was 12.1 % and the floor effect was 21.6 %, for the global questionnaire. Large sensitivity to change was shown. the Spanish version of iHOT-33 has shown to be feasible, reliable and sensible to changes for patients undergoing hip arthroscopy. This validated translation of iHOT-33 allows for comparisons between studies involving either Spanish- or English-speaking patients. Prognostic study, Level I.

Oncology biomarkers: discovery, validation, and clinical use.

PubMed

Heckman-Stoddard, Brandy M

2012-05-01

To discuss the discovery, validation, and clinical use of multiple types of biomarkers. Medical literature and published guidelines. Formal validation of biomarkers should include both retrospective analyses of well-characterized samples as well as a prospective clinical trial in which the biomarker is tested for its ability to predict the presence of disease or the efficacy of a cancer therapy. Biomarker development is complicated, with very few biomarker discoveries leading to clinically useful tests. Nurses should understand how a biomarker was developed, including the sensitivity and specificity before applying new biomarkers in the clinical setting. Copyright © 2012. Published by Elsevier Inc.

Temperament and problem solving in a population of adolescent guide dogs.

PubMed

Bray, Emily E; Sammel, Mary D; Seyfarth, Robert M; Serpell, James A; Cheney, Dorothy L

2017-09-01

It is often assumed that measures of temperament within individuals are more correlated to one another than to measures of problem solving. However, the exact relationship between temperament and problem-solving tasks remains unclear because large-scale studies have typically focused on each independently. To explore this relationship, we tested 119 prospective adolescent guide dogs on a battery of 11 temperament and problem-solving tasks. We then summarized the data using both confirmatory factor analysis and exploratory principal components analysis. Results of confirmatory analysis revealed that a priori separation of tests as measuring either temperament or problem solving led to weak results, poor model fit, some construct validity, and no predictive validity. In contrast, results of exploratory analysis were best summarized by principal components that mixed temperament and problem-solving traits. These components had both construct and predictive validity (i.e., association with success in the guide dog training program). We conclude that there is complex interplay between tasks of "temperament" and "problem solving" and that the study of both together will be more informative than approaches that consider either in isolation.

Free-breathing whole-heart 3D cine magnetic resonance imaging with prospective respiratory motion compensation.

PubMed

Moghari, Mehdi H; Barthur, Ashita; Amaral, Maria E; Geva, Tal; Powell, Andrew J

2018-07-01

To develop and validate a new prospective respiratory motion compensation algorithm for free-breathing whole-heart 3D cine steady-state free precession (SSFP) imaging. In a 3D cine SSFP sequence, 4 excitations per cardiac cycle are re-purposed to prospectively track heart position. Specifically, their 1D image is reconstructed and routed into the scanner's standard diaphragmatic navigator processing system. If all 4 signals are in end-expiration, cine image data from the entire cardiac cycle is accepted for image reconstruction. Prospective validation was carried out in patients (N = 17) by comparing in each a conventional breath-hold 2D cine ventricular short-axis stack and a free-breathing whole-heart 3D cine data set. All 3D cine SSFP acquisitions were successful and the mean scan time was 5.9 ± 2.7 min. Left and right ventricular end-diastolic, end-systolic, and stroke volumes by 3D cine SSFP were all larger than those from 2D cine SSFP. This bias was < 6% except for right ventricular end-systolic volume that was 12%. The 3D cine images had a lower ventricular blood-to-myocardium contrast ratio, contrast-to-noise ratio, mass, and subjective quality score. The novel prospective respiratory motion compensation method for 3D cine SSFP imaging was robust and efficient and yielded slightly larger ventricular volumes and lower mass compared to breath-hold 2D cine imaging. Magn Reson Med 80:181-189, 2018. © 2017 International Society for Magnetic Resonance in Medicine. © 2017 International Society for Magnetic Resonance in Medicine.

Cross-cultural adaptation and validation of the Injury-Psychological Readiness to Return to Sport scale to Persian language.

PubMed

Naghdi, Soofia; Nakhostin Ansari, Noureddin; Farhadi, Yasaman; Ebadi, Safoora; Entezary, Ebrahim; Glazer, Douglas

2016-10-01

The aim of the present study was to develop and provide validation statistics for the Persian Injury-Psychological Readiness to Return to Sport scale (I-PRRS) following a cross-sectional and prospective cohort study design. The I-PRRS was forward/back-translated and culturally adapted into Persian language. The Persian I-PRRS was administered to 100 injured athletes (93 male; age 26.0 ± 5.6 years; time since injury 4.84 ± 6.4 months) and 50 healthy athletes (36 male; mean age 25.7 ± 6.0 years). The Persian I-PRRS was re-administered to 50 injured athletes at 1 week to examine test-retest reliability. There were no floor or ceiling effects confirming the content validity of Persian I-PRRS. The internal consistency reliability was good. Excellent test-retest reliability and agreement were demonstrated. The statistically significant difference in Persian I-PRRS total scores between the injured athletes and healthy athletes provides an evidence of discriminative validity. The Persian I-PRRS total scores were positively correlated with the Farsi Mood Scale (FARMS) total scores, showing construct validity. The principal component analysis indicated a two-factor solution consisting of "Confidence to play" and "Confidence in the injured body part and skill level". The Persian I-PRRS showed excellent reliability and validity and can be used to assess injured athletes' psychological readiness to return to sport among Persian-speaking populations.

Cross-cultural adaptation and validation of Persian Achilles tendon Total Rupture Score.

PubMed

Ansari, Noureddin Nakhostin; Naghdi, Soofia; Hasanvand, Sahar; Fakhari, Zahra; Kordi, Ramin; Nilsson-Helander, Katarina

2016-04-01

To cross-culturally adapt the Achilles tendon Total Rupture Score (ATRS) to Persian language and to preliminary evaluate the reliability and validity of a Persian ATRS. A cross-sectional and prospective cohort study was conducted to translate and cross-culturally adapt the ATRS to Persian language (ATRS-Persian) following steps described in guidelines. Thirty patients with total Achilles tendon rupture and 30 healthy subjects participated in this study. Psychometric properties of floor/ceiling effects (responsiveness), internal consistency reliability, test-retest reliability, standard error of measurement (SEM), smallest detectable change (SDC), construct validity, and discriminant validity were tested. Factor analysis was performed to determine the ATRS-Persian structure. There were no floor or ceiling effects that indicate the content and responsiveness of ATRS-Persian. Internal consistency was high (Cronbach's α 0.95). Item-total correlations exceeded acceptable standard of 0.3 for the all items (0.58-0.95). The test-retest reliability was excellent [(ICC)agreement 0.98]. SEM and SDC were 3.57 and 9.9, respectively. Construct validity was supported by a significant correlation between the ATRS-Persian total score and the Persian Foot and Ankle Outcome Score (PFAOS) total score and PFAOS subscales (r = 0.55-0.83). The ATRS-Persian significantly discriminated between patients and healthy subjects. Explanatory factor analysis revealed 1 component. The ATRS was cross-culturally adapted to Persian and demonstrated to be a reliable and valid instrument to measure functional outcomes in Persian patients with Achilles tendon rupture. II.

Making and Executing Decisions for Safe and Independent Living (MED-SAIL): development and validation of a brief screening tool.

PubMed

Mills, Whitney L; Regev, Tziona; Kunik, Mark E; Wilson, Nancy L; Moye, Jennifer; McCullough, Laurence B; Naik, Aanand D

2014-03-01

Older adults prefer to remain in their own homes for as long as possible. The purpose of this article is to describe the development and preliminary validation of Making and Executing Decisions for Safe and Independent Living (MED-SAIL), a brief screening tool for capacity to live safely and independently in the community. Prospective preliminary validation study. Outpatient geriatrics clinic located in a community-based hospital. Forty-nine community-dwelling older adults referred to the clinic for a comprehensive capacity assessment. We examined internal consistency, criterion-based validity, concurrent validity, and accuracy of classification for MED-SAIL. The items included in MED-SAIL demonstrated internal consistency (5 items; α = 0.85). MED-SAIL was significantly correlated with the Independent Living Scales (r = 0.573, p ≤0.001) and instrumental activities of daily living (r = 0.440, p ≤0.01). The Mann-Whitney U test revealed significant differences between the no capacity and partial/full capacity classifications on MED-SAIL (U(48) = 60.5, Z = -0.38, p <0.0001). The area under the curve was 0.864 (95% confidence interval: 0.84-0.99). This study demonstrated the validity of MED-SAIL as a brief screening tool to identify older adults with impaired capacity for remaining safe and independent in their current living environment. MED-SAIL is useful tool for health and social service providers in the community for the purpose of referral for definitive capacity evaluation. Published by Elsevier Inc.

Leflunomide in active rheumatoid arthritis: a prospective study in daily practice.

PubMed

Van Roon, E N; Jansen, T L Th A; Mourad, L; Houtman, P M; Bruyn, G A W; Griep, E N; Wilffert, B; Tobi, H; Brouwers, J R B J

2004-06-01

We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. In this prospective case series study, from outpatient medical records a standard dataset was collected including patient and disease characteristics, data on leflunomide use and adverse drug reactions. During the study period 136 rheumatoid arthritis patients started leflunomide. Median (range) follow-up duration was 317 (11-911) days. Sixty-five percent of patients experienced at least one adverse drug reaction related to leflunomide. During follow-up 76 patients (56%) withdrew from leflunomide treatment, mainly because of adverse drug reactions (29%) or lack of efficacy (13%). The overall incidence density for withdrawal from leflunomide was 56.2 per 100 patient-years. Complete data for calculating efficacy using a validated disease activity score on 28 joints (DAS(28)) was available for 48, 36, and 35% of patients at 2, 6, and 12 months follow-up, respectively. Within a 12-month period after start of leflunomide treatment 76% of the evaluable patients were classified as moderate or good responders according to the DAS(28) response criteria. In the setting of care-as-usual, rheumatoid arthritis patients starting leflunomide frequently experienced adverse drug reactions. More than half of the patients withdrew from leflunomide treatment within a year after start of leflunomide treatment, mainly because of adverse drug reactions.

Leflunomide in active rheumatoid arthritis: a prospective study in daily practice.

PubMed

Van Roon, E N; Jansen, T L Th A; Mourad, L; Houtman, P M; Bruyn, G A W; Griep, E N; Wilffert, B; Tobi, H; Brouwers, J R B J

2004-08-01

We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. In this prospective case series study, a standard dataset was collected from outpatient medical records, including patient and disease characteristics, data on leflunomide use and adverse drug reactions. During the study period 136 rheumatoid arthritis patients started leflunomide. Median (range) follow-up duration was 317 (11-911) days. Sixty-five percent of patients experienced at least one adverse drug reaction related to leflunomide. During follow-up 76 patients (56%) withdrew from leflunomide treatment, mainly because of adverse drug reactions (29%) or lack of efficacy (13%). The overall incidence density for withdrawal from leflunomide was 56.2 per 100 patient years. Complete data for calculating efficacy using a validated disease activity score on 28 joints (DAS(28)) was available for 48, 36, and 35% of patients at 2, 6, and 12 months follow-up, respectively. Within a 12-month period after start of leflunomide treatment 76% of the evaluable patients were classified as moderate or good responders according to the DAS(28) response criteria. In the setting of care-as-usual rheumatoid arthritis patients starting leflunomide frequently experienced adverse drug reactions. More than half of the patients withdrew from leflunomide treatment within 1 year of starting leflunomide treatment, mainly because of adverse drug reactions.

China Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction: Study Design.

PubMed

Li, Jing; Dreyer, Rachel P; Li, Xi; Du, Xue; Downing, Nicholas S; Li, Li; Zhang, Hai-Bo; Feng, Fang; Guan, Wen-Chi; Xu, Xiao; Li, Shu-Xia; Lin, Zhen-Qiu; Masoudi, Frederick A; Spertus, John A; Krumholz, Harlan M; Jiang, Li-Xin

2016-01-05

Despite the rapid growth in the incidence of acute myocardial infarction (AMI) in China, there is limited information about patients' experiences after AMI hospitalization, especially on long-term adverse events and patient-reported outcomes (PROs). The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Prospective AMI Study will enroll 4000 consecutive AMI patients from 53 diverse hospitals across China and follow them longitudinally for 12 months to document their treatment, recovery, and outcomes. Details of patients' medical history, treatment, and in-hospital outcomes are abstracted from medical charts. Comprehensive baseline interviews are being conducted to characterize patient demographics, risk factors, presentation, and healthcare utilization. As part of these interviews, validated instruments are administered to measure PROs, including quality of life, symptoms, mood, cognition, and sexual activity. Follow-up interviews, measuring PROs, medication adherence, risk factor control, and collecting hospitalization events are conducted at 1, 6, and 12 months after discharge. Supporting documents for potential outcomes are collected for adjudication by clinicians at the National Coordinating Center. Blood and urine samples are also obtained at baseline, 1- and 12-month follow-up. In addition, we are conducting a survey of participating hospitals to characterize their organizational characteristics. The China PEACE-Prospective AMI study will be uniquely positioned to generate new information regarding patient's experiences and outcomes after AMI in China and serve as a foundation for quality improvement activities.

Nonoperative management in children with early acute appendicitis: A systematic review.

PubMed

Xu, Jane; Adams, Susan; Liu, Yingrui Cyril; Karpelowsky, Jonathan

2017-09-01

Appendectomy has remained the gold standard treatment of acute appendicitis for more than 100years. Nonoperative management (NOM) has been shown to be a valid treatment alternative for acute uncomplicated appendicitis in adults. A systematic review of available evidence comparing operative management (OM) and NOM in children with acute uncomplicated appendicitis was performed. Systematic searches of MedLine, Embase, and a clinical trial register (https://clinicaltrials.gov/) were performed in March 2016. Only articles that studied NOM for uncomplicated appendicitis in children were included. Data generation was performed independently by two authors, and quality was assessed using the rating schema by the Oxford Centre for Evidence-Based Medicine. 15 articles were selected: four retrospective analyses, four prospective cohort studies, four prospective nonrandomized comparative trials and one randomized controlled trial (RCT). Initial success of the NOM groups (a cure within two weeks of intervention) ranged from 58 to 100%, with 0.1-31.8% recurrence at one year. Although present literature is scarce, publications support the feasibility of further studies investigating NOM of acute uncomplicated appendicitis in children. Higher quality prospective RCTs with larger sample sizes and robust randomization methods, studying the noninferiority of NOM with antibiotics compared with OM are required to establish its utility. This manuscript is a systematic review and thus assigned the lowest evidence used from the manuscripts analyzed which is a Level IV. Copyright © 2017. Published by Elsevier Inc.

Risk factors of significant pain syndrome 90 days after minor thoracic injury: trajectory analysis.

PubMed

Daoust, Raoul; Emond, Marcel; Bergeron, Eric; LeSage, Natalie; Camden, Stéphanie; Guimont, Chantal; Vanier, Laurent; Chauny, Jean-Marc

2013-11-01

The objective was to identify the risk factors of clinically significant pain at 90 days in patients with minor thoracic injury (MTI) discharged from the emergency department (ED). A prospective, multicenter, cohort study was conducted in four Canadian EDs from November 2006 to November 2010. All consecutive patients aged 16 years or older with MTI were eligible at discharge from EDs. They underwent standardized clinical and radiologic evaluations at 1 and 2 weeks, followed by standardized telephone interviews at 30 and 90 days. A pain trajectory model characterized groups of patients with different pain evolutions and ascertained specific risk factors in each group through multivariate analysis. In this cohort of 1,132 patients, 734 were eligible for study inclusion. The authors identified a pain trajectory that characterized 18.2% of the study population experiencing clinically significant pain (>3 of 10) at 90 days after a MTI. Multivariate modeling found two or more rib fractures, smoking, and initial oxygen saturation below 95% to be predictors of this group of patients. To the authors' knowledge, this is the first prospective study of trajectory modeling to detect risk factors associated with significant pain at 90 days after MTI. These factors may help in planning specific treatment strategies and should be validated in another prospective cohort. © 2013 by the Society for Academic Emergency Medicine.

Cross-cultural adaptation of the German version of the spinal stenosis measure.

PubMed

Wertli, Maria M; Steurer, Johann; Wildi, Lukas M; Held, Ulrike

2014-06-01

To validate the German version of the spinal stenosis measure (SSM), a disease-specific questionnaire assessing symptom severity, physical function, and satisfaction with treatment in patients with lumbar spinal stenosis. After translation, cross-cultural adaptation, and pilot testing, we assessed internal consistency, test-retest reliability, construct validity, and responsiveness of the SSM subscales. Data from a large Swiss multi-center prospective cohort study were used. Reference scales for the assessment of construct validity and responsiveness were the numeric rating scale, pain thermometer, and the Roland Morris Disability Questionnaire. One hundred and eight consecutive patients were included in this validation study, recruited from five different centers. Cronbach's alpha was above 0.8 for all three subscales of the SSM. The objectivity of the SSM was assessed using a partial credit approach. The model showed a good global fit to the data. Of the 108 patients 78 participated in the test-retest procedure. The ICC values were above 0.8 for all three subscales of the SSM. Correlations with reference scales were above 0.7 for the symptom and function subscales. For satisfaction subscale, it was 0.66 or above. Clinically meaningful changes of the reference scales over time were associated with significantly more improvement in all three SSM subscales (p < 0.001). Conclusion: The proposed version of the SSM showed very good measurement properties and can be considered validated for use in the German language.

Validation of periodontitis screening model using sociodemographic, systemic, and molecular information in a Korean population.

PubMed

Kim, Hyun-Duck; Sukhbaatar, Munkhzaya; Shin, Myungseop; Ahn, Yoo-Been; Yoo, Wook-Sung

2014-12-01

This study aims to evaluate and validate a periodontitis screening model that includes sociodemographic, metabolic syndrome (MetS), and molecular information, including gingival crevicular fluid (GCF), matrix metalloproteinase (MMP), and blood cytokines. The authors selected 506 participants from the Shiwha-Banwol cohort: 322 participants from the 2005 cohort for deriving the screening model and 184 participants from the 2007 cohort for its validation. Periodontitis was assessed by dentists using the community periodontal index. Interleukin (IL)-6, IL-8, and tumor necrosis factor-α in blood and MMP-8, -9, and -13 in GCF were assayed using enzyme-linked immunosorbent assay. MetS was assessed by physicians using physical examination and blood laboratory data. Information about age, sex, income, smoking, and drinking was obtained by interview. Logistic regression analysis was applied to finalize the best-fitting model and validate the model using sensitivity, specificity, and c-statistics. The derived model for periodontitis screening had a sensitivity of 0.73, specificity of 0.85, and c-statistic of 0.86 (P <0.001); those of the validated model were 0.64, 0.91, and 0.83 (P <0.001), respectively. The model that included age, sex, income, smoking, drinking, and blood and GCF biomarkers could be useful in screening for periodontitis. A future prospective study is indicated for evaluating this model's ability to predict the occurrence of periodontitis.

Validation of the Spanish adaptation of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V).

PubMed

Núñez-Batalla, Faustino; Morato-Galán, Marta; García-López, Isabel; Ávila-Menéndez, Arántzazu

2015-01-01

The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) was developed.to promote a standardised approach to evaluating and documenting auditory perceptual judgments of vocal quality. This tool was originally developed in English language and its Spanish version is still inexistent. The aim of this study was to develop a Spanish adaptation of CAPE-V and to examine the reliability and empirical validity of this Spanish version. To adapt the CAPE-V protocol to the Spanish language, we proposed 6 phrases phonetically designed according to the CAPE-V requirements. Prospective instrument validation was performed. The validity of the Spanish version of the CAPE-V was examined in 4 ways: intra-rater reliability, inter-rater reliability and CAPE-V versus GRABS judgments. Inter-rater reliability coefficients for the CAPE-V ranged from 0.93 for overall severity to 0.54 for intensity; intra-rater reliability ranged from 0.98 for overall severity to 0.85 for intensity. The comparison of judgments between GRABS and CAPE-V ranged from 0.86 for overall severity to 0.61 for breathiness. The present study supports the use of the Spanish version of CAPE-V because of its validity and reliability. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

Reliable and valid tools for measuring surgeons' teaching performance: residents' vs. self evaluation.

PubMed

Boerebach, Benjamin C M; Arah, Onyebuchi A; Busch, Olivier R C; Lombarts, Kiki M J M H

2012-01-01

In surgical education, there is a need for educational performance evaluation tools that yield reliable and valid data. This paper describes the development and validation of robust evaluation tools that provide surgeons with insight into their clinical teaching performance. We investigated (1) the reliability and validity of 2 tools for evaluating the teaching performance of attending surgeons in residency training programs, and (2) whether surgeons' self evaluation correlated with the residents' evaluation of those surgeons. We surveyed 343 surgeons and 320 residents as part of a multicenter prospective cohort study of faculty teaching performance in residency training programs. The reliability and validity of the SETQ (System for Evaluation Teaching Qualities) tools were studied using standard psychometric techniques. We then estimated the correlations between residents' and surgeons' evaluations. The response rate was 87% among surgeons and 84% among residents, yielding 2625 residents' evaluations and 302 self evaluations. The SETQ tools yielded reliable and valid data on 5 domains of surgical teaching performance, namely, learning climate, professional attitude towards residents, communication of goals, evaluation of residents, and feedback. The correlations between surgeons' self and residents' evaluations were low, with coefficients ranging from 0.03 for evaluation of residents to 0.18 for communication of goals. The SETQ tools for the evaluation of surgeons' teaching performance appear to yield reliable and valid data. The lack of strong correlations between surgeons' self and residents' evaluations suggest the need for using external feedback sources in informed self evaluation of surgeons. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Adaptation and validation of the Dutch version of the nasal obstruction symptom evaluation (NOSE) scale.

PubMed

van Zijl, Floris V W J; Timman, Reinier; Datema, Frank R

2017-06-01

The nasal obstruction symptom evaluation (NOSE) scale is a validated disease-specific, self-completed questionnaire for the assessment of quality of life related to nasal obstruction. The aim of this study was to validate the Dutch (NL-NOSE) questionnaire. A prospective instrument validation study was performed in a tertiary academic referral center. Guidelines for the cross-cultural adaptation process from the original English language scale into a Dutch language version were followed. Patients undergoing functional septoplasty or septorhinoplasty and asymptomatic controls completed the questionnaire both before and 3 months after surgery to test reliability and validity. Additionally, we explored the possibility to reduce the NOSE scale even further using graded response models. 129 patients and 50 controls were included. Internal consistency (Cronbach's alpha 0.82) and test-retest reliability (intraclass correlation coefficient 0.89) were good. The instrument showed excellent between-group discrimination (Mann-Whitney U = 85, p < 0.001) and high response sensitivity to change (Wilcoxon rank p < 0.001). The NL-NOSE correlated well with the score on a visual analog scale measuring the subjective sensation of nasal obstruction, with exception of item 4 (trouble sleeping). Item 4 provided the least information to the total scale and item 3 (trouble breathing through nose) the most, particularly in the postoperative group. The Dutch version of the NOSE (NL-NOSE) demonstrated satisfactory reliability and validity. We recommend the use of the NL-NOSE as a validated instrument to measure subjective severity of nasal obstruction in Dutch adult patients.

Blood-based protein biomarkers for diagnosis of Alzheimer disease.

PubMed

Doecke, James D; Laws, Simon M; Faux, Noel G; Wilson, William; Burnham, Samantha C; Lam, Chiou-Peng; Mondal, Alinda; Bedo, Justin; Bush, Ashley I; Brown, Belinda; De Ruyck, Karl; Ellis, Kathryn A; Fowler, Christopher; Gupta, Veer B; Head, Richard; Macaulay, S Lance; Pertile, Kelly; Rowe, Christopher C; Rembach, Alan; Rodrigues, Mark; Rumble, Rebecca; Szoeke, Cassandra; Taddei, Kevin; Taddei, Tania; Trounson, Brett; Ames, David; Masters, Colin L; Martins, Ralph N

2012-10-01

To identify plasma biomarkers for the diagnosis of Alzheimer disease (AD). Baseline plasma screening of 151 multiplexed analytes combined with targeted biomarker and clinical pathology data. General community-based, prospective, longitudinal study of aging. A total of 754 healthy individuals serving as controls and 207 participants with AD from the Australian Imaging Biomarker and Lifestyle study (AIBL) cohort with identified biomarkers that were validated in 58 healthy controls and 112 individuals with AD from the Alzheimer Disease Neuroimaging Initiative (ADNI) cohort. A biomarker panel was identified that included markers significantly increased (cortisol, pancreatic polypeptide, insulinlike growth factor binding protein 2, β(2) microglobulin, vascular cell adhesion molecule 1, carcinoembryonic antigen, matrix metalloprotein 2, CD40, macrophage inflammatory protein 1α, superoxide dismutase, and homocysteine) and decreased (apolipoprotein E, epidermal growth factor receptor, hemoglobin, calcium, zinc, interleukin 17, and albumin) in AD. Cross-validated accuracy measures from the AIBL cohort reached a mean (SD) of 85% (3.0%) for sensitivity and specificity and 93% (3.0) for the area under the receiver operating characteristic curve. A second validation using the ADNI cohort attained accuracy measures of 80% (3.0%) for sensitivity and specificity and 85% (3.0) for area under the receiver operating characteristic curve. This study identified a panel of plasma biomarkers that distinguish individuals with AD from cognitively healthy control subjects with high sensitivity and specificity. Cross-validation within the AIBL cohort and further validation within the ADNI cohort provides strong evidence that the identified biomarkers are important for AD diagnosis.

Questionnaire-based evaluation of sexual life after laparoscopic surgery for endometriosis: a systematic review of prospective studies.

PubMed

Franck, Cecilie; Poulsen, Marlene H; Karampas, Grigorios; Giraldi, Annamaria; Rudnicki, Martin

2018-05-12

Endometriosis is a benign disease that affects women of reproductive age. Laparoscopic excision of endometriotic implants is considered one of the most effective therapeutic options. The disease and its treatment can have a major impact on psychosexual well-being but this is often overlooked as most studies focus on pain instead of sexuality in a holistic approach. The aim of this study was to review the current literature regarding the effect of laparoscopic surgery for endometriosis on quality of sexual life (QoSL). Following the "Preferred Reporting Items for Systematic Reviews and Meta-Analyses" guidelines we conducted a systematic review that involved searching PubMed and Embase databases for prospective studies evaluating the effect of laparoscopic surgery for endometriosis on QoSL, using validated questionnaires. Of 357 papers, 17 were selected for full text evaluation. Twelve studies using seven different questionnaires fulfilled the inclusion criteria. All studies reported improvements in QoSL following laparoscopic surgery for endometriosis. A meta-analysis could not be performed due to substantial heterogeneity among the included studies arising from differences in questionnaires, follow-up duration, stages of endometriosis, use of hormonal treatment, and missing data. Laparoscopic excision of endometriosis can improve QoSL. However, there is a need for randomized controlled trials based on a new validated questionnaire regarding specifically QoSL in association with endometriosis. As sexual functioning is a complex phenomenon driven by multiple physical, psychological and social factors, QoSL should be holistically evaluated by a team of different healthcare providers, implementing treatment programs that are individualized to each woman. © 2018 Nordic Federation of Societies of Obstetrics and Gynecology.

A prospective study evaluating the Pressure Ulcer Scale for Healing (PUSH Tool) to assess stage II, stage III, and stage IV pressure ulcers.

PubMed

Günes, Ulkü Yapucu

2009-05-01

Many valid and reliable tools and techniques are available for wound measurement. However, few prospective clinical studies assessing these instruments have been conducted. A prospective, methodological study was conducted between September 2006 and November 2007 to evaluate use of the Pressure Ulcer Scale for Healing (PUSH) version 3 in patients with one or more pressure ulcer. A convenience sample of 72 persons (mean age 66.9 +/- 12.8 years) with 86 pressure ulcers (49% Stage II, 47% Stage III, and 4% Stage IV) was recruited and assessed weekly until healing, transfer, patient death, or end of study for a maximum of 8 weeks. Most ulcers (77%) were in the sacral area and 56% had been present for 1 month or longer. Repeated measures analysis revealed that PUSH total scores decreased significantly (P < 0.001) over the 8-week study, with significant differences in PUSH total scores between healed and unhealed ulcers each week, starting on week 1. The total PUSH score as well as the length x width item in the tool accurately differentiated between healed and nonhealed ulcers. Although the PUSH tool is practical, easy-to-use, and generally sensitive to change, some modifications would improve its value--ie, a wound size/depth subscale. Additional studies to help clinicians more accurately evaluate the effectiveness of their interventions, including studies to determine whether wound measurements alone may suffice to monitor healing, are needed.

[When should a patient with musculoskeletal trauma be referred to emergency ward?].

PubMed

Feiner, Adam-Scott; Duruz, Henri

2010-08-25

Standardized clinical examination can obviate the need for osteoarticular radiographs for trauma. This paper summarizes a number of decision rules that allow clinical exclusion of significant fracture of the cervical spine, elbow, knee or ankle, making radiographs unnecessary. These criteria were all derived from large cohort studies (Nexus, Ottawa, CCS, etc..., and have been prospectively validated. The rigorous use of these criteria in daily practice improves treatment times and costs with no adverse effect on treatment quality.

Predictors of one and two years' mortality in patients with colon cancer: A prospective cohort study.

PubMed

Quintana, José M; Antón-Ladislao, Ane; González, Nerea; Lázaro, Santiago; Baré, Marisa; Fernández-de-Larrea, Nerea; Redondo, Maximino; Briones, Eduardo; Escobar, Antonio; Sarasqueta, Cristina; García-Gutierrez, Susana; Aróstegui, Inmaculada

2018-01-01

Tools to aid in the prognosis assessment of colon cancer patients in terms of risk of mortality are needed. Goals of this study are to develop and validate clinical prediction rules for 1- and 2-year mortality in these patients. This is a prospective cohort study of patients diagnosed with colon cancer who underwent surgery at 22 hospitals. The main outcomes were mortality at 1 and 2 years after surgery. Background, clinical parameters, and diagnostic tests findings were evaluated as possible predictors. Multivariable multilevel logistic regression and survival models were used in the analyses to create the clinical prediction rules. Models developed in the derivation sample were validated in another sample of the study. American Society of Anesthesiologists Physical Status Classification System (ASA), Charlson comorbidity index (> = 4), age (>75 years), residual tumor (R2), TNM stage IV and log of lymph nodes ratio (> = -0.53) were predictors of 1-year mortality (C-index (95% CI): 0.865 (0.792-0.938)). Adjuvant chemotherapy was an additional predictor. Again ASA, Charlson Index (> = 4), age (>75 years), log of lymph nodes ratio (> = -0.53), TNM, and residual tumor were predictors of 2-year mortality (C-index:0.821 (0.766-0.876). Chemotherapy was also an additional predictor. These clinical prediction rules show very good predictive abilities of one and two years survival and provide clinicians and patients with an easy and quick-to-use decision tool for use in the clinical decision process while the patient is still in the index admission.

Handheld calorimeter is a valid instrument to quantify resting energy expenditure in hospitalized cirrhotic patients: a prospective study.

PubMed

Glass, Cathy; Hipskind, Peggy; Cole, Denise; Lopez, Rocio; Dasarathy, Srinivasan

2012-10-01

Nutrition management of cirrhosis in hospitalized patients is overlooked despite the clinical significance of sarcopenia or loss of muscle mass in cirrhosis. Determining optimal nutrition requirement needs precise measurement of resting energy expenditure (REE) in the cirrhotic patient. Predictive equations are not accurate, and the metabolic cart is expensive and cumbersome. The authors therefore performed a prospective study to examine the feasibility and accuracy of a handheld respiratory calorimeter (HHRC) in quantifying the REE in hospitalized cirrhotic patients not in the intensive care unit. The study was done in 2 phases: in the first phase, the REE of 24 consecutive healthy volunteers was measured using an HHRC in different positions. The objective of this phase was to identify the impact of body and arm position on measured REE. Subsequently, in the second phase of the study, REE was measured using the HHRC and the metabolic cart in 25 consecutive well-characterized, hospitalized cirrhotic patients. The degree of concordance was calculated. Body position and arm position did not significantly affect the measured REE using HHRC. In patients with cirrhosis, the mean measured REE (kcal/d) using the HHRC was 1453.2 ± 319.3 in the hospital room, 1525.6 ± 305.2 in a quiet environment, and 1553.7 ± 270.6 with the metabolic cart (P > .1). Predicted REE using 2 widely used equations did not correlate either with each other or with the measured REE. HHRC is a valid, feasible, and rapid method to determine optimal caloric needs in hospitalized cirrhotic patients.

The Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL): a pilot study exploring validity and feasibility in clinical practice

PubMed Central

2014-01-01

Background The Richmond Agitation-Sedation Scale (RASS), which assesses level of sedation and agitation, is a simple observational instrument which was developed and validated for the intensive care setting. Although used and recommended in palliative care settings, further validation is required in this patient population. The aim of this study was to explore the validity and feasibility of a version of the RASS modified for palliative care populations (RASS-PAL). Methods A prospective study, using a mixed methods approach, was conducted. Thirteen health care professionals (physicians and nurses) working in an acute palliative care unit assessed ten consecutive patients with an agitated delirium or receiving palliative sedation. Patients were assessed at five designated time points using the RASS-PAL. Health care professionals completed a short survey and data from semi-structured interviews was analyzed using thematic analysis. Results The inter-rater intraclass correlation coefficient range of the RASS-PAL was 0.84 to 0.98 for the five time points. Professionals agreed that the tool was useful for assessing sedation and was easy to use. Its role in monitoring delirium however was deemed problematic. Professionals felt that it may assist interprofessional communication. The need for formal education on why and how to use the instrument was highlighted. Conclusion This study provides preliminary validity evidence for the use of the RASS-PAL by physicians and nurses working in a palliative care unit, specifically for assessing sedation and agitation levels in the management of palliative sedation. Further validity evidence should be sought, particularly in the context of assessing delirium. PMID:24684942

Prediction of Outcome after Moderate and Severe Traumatic Brain Injury: External Validation of the IMPACT and CRASH Prognostic Models

PubMed Central

Roozenbeek, Bob; Lingsma, Hester F.; Lecky, Fiona E.; Lu, Juan; Weir, James; Butcher, Isabella; McHugh, Gillian S.; Murray, Gordon D.; Perel, Pablo; Maas, Andrew I.R.; Steyerberg, Ewout W.

2012-01-01

Objective The International Mission on Prognosis and Analysis of Clinical Trials (IMPACT) and Corticoid Randomisation After Significant Head injury (CRASH) prognostic models predict outcome after traumatic brain injury (TBI) but have not been compared in large datasets. The objective of this is study is to validate externally and compare the IMPACT and CRASH prognostic models for prediction of outcome after moderate or severe TBI. Design External validation study. Patients We considered 5 new datasets with a total of 9036 patients, comprising three randomized trials and two observational series, containing prospectively collected individual TBI patient data. Measurements Outcomes were mortality and unfavourable outcome, based on the Glasgow Outcome Score (GOS) at six months after injury. To assess performance, we studied the discrimination of the models (by AUCs), and calibration (by comparison of the mean observed to predicted outcomes and calibration slopes). Main Results The highest discrimination was found in the TARN trauma registry (AUCs between 0.83 and 0.87), and the lowest discrimination in the Pharmos trial (AUCs between 0.65 and 0.71). Although differences in predictor effects between development and validation populations were found (calibration slopes varying between 0.58 and 1.53), the differences in discrimination were largely explained by differences in case-mix in the validation studies. Calibration was good, the fraction of observed outcomes generally agreed well with the mean predicted outcome. No meaningful differences were noted in performance between the IMPACT and CRASH models. More complex models discriminated slightly better than simpler variants. Conclusions Since both the IMPACT and the CRASH prognostic models show good generalizability to more recent data, they are valid instruments to quantify prognosis in TBI. PMID:22511138

Teamwork Assessment Tools in Obstetric Emergencies: A Systematic Review.

PubMed

Onwochei, Desire N; Halpern, Stephen; Balki, Mrinalini

2017-06-01

Team-based training and simulation can improve patient safety, by improving communication, decision making, and performance of team members. Currently, there is no general consensus on whether or not a specific assessment tool is better adapted to evaluate teamwork in obstetric emergencies. The purpose of this qualitative systematic review was to find the tools available to assess team effectiveness in obstetric emergencies. We searched Embase, Medline, PubMed, Web of Science, PsycINFO, CINAHL, and Google Scholar for prospective studies that evaluated nontechnical skills in multidisciplinary teams involving obstetric emergencies. The search included studies from 1944 until January 11, 2016. Data on reliability and validity measures were collected and used for interpretation. A descriptive analysis was performed on the data. Thirteen studies were included in the final qualitative synthesis. All the studies assessed teams in the context of obstetric simulation scenarios, but only six included anesthetists in the simulations. One study evaluated their teamwork tool using just validity measures, five using just reliability measures, and one used both. The most reliable tools identified were the Clinical Teamwork Scale, the Global Assessment of Obstetric Team Performance, and the Global Rating Scale of performance. However, they were still lacking in terms of quality and validity. More work needs to be conducted to establish the validity of teamwork tools for nontechnical skills, and the development of an ideal tool is warranted. Further studies are required to assess how outcomes, such as performance and patient safety, are influenced when using these tools.

Development of a pharmacogenetic-guided warfarin dosing algorithm for Puerto Rican patients.

PubMed

Ramos, Alga S; Seip, Richard L; Rivera-Miranda, Giselle; Felici-Giovanini, Marcos E; Garcia-Berdecia, Rafael; Alejandro-Cowan, Yirelia; Kocherla, Mohan; Cruz, Iadelisse; Feliu, Juan F; Cadilla, Carmen L; Renta, Jessica Y; Gorowski, Krystyna; Vergara, Cunegundo; Ruaño, Gualberto; Duconge, Jorge

2012-12-01

This study was aimed at developing a pharmacogenetic-driven warfarin-dosing algorithm in 163 admixed Puerto Rican patients on stable warfarin therapy. A multiple linear-regression analysis was performed using log-transformed effective warfarin dose as the dependent variable, and combining CYP2C9 and VKORC1 genotyping with other relevant nongenetic clinical and demographic factors as independent predictors. The model explained more than two-thirds of the observed variance in the warfarin dose among Puerto Ricans, and also produced significantly better 'ideal dose' estimates than two pharmacogenetic models and clinical algorithms published previously, with the greatest benefit seen in patients ultimately requiring <7 mg/day. We also assessed the clinical validity of the model using an independent validation cohort of 55 Puerto Rican patients from Hartford, CT, USA (R(2) = 51%). Our findings provide the basis for planning prospective pharmacogenetic studies to demonstrate the clinical utility of genotyping warfarin-treated Puerto Rican patients.

Quality of Life after Brain Injury (QOLIBRI) Overall Scale for patients after aneurysmal subarachnoid hemorrhage.

PubMed

Wong, George Kwok Chu; Lam, Sandy Wai; Ngai, Karine; Wong, Adrian; Mok, Vincent; Poon, Wai Sang

2014-06-01

The Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS) is a recently developed instrument that provides a brief summary measure of health-related quality of life (HRQoL) in domains typically affected by brain injury. This study examined the application of the six item QOLIBRI-OS in patients after aneurysmal subarachnoid hemorrhage (aSAH). Hong Kong Chinese aSAH patients were evaluated prospectively within the chronic phase of 1 year after aSAH in this multi-center observational study. Cronbach's α was 0.88, and correlations were satisfactory for all six items. QOLIBRI-OS demonstrated good criterion validity with other 1 year outcome assessments. In conclusion, QOLIBRI-OS can be used as a brief index for disease-specific HRQoL assessment after aSAH. Further validation in another population of aSAH patients is recommended. Copyright © 2013 Elsevier Ltd. All rights reserved.

Level of evidence for therapeutic drug monitoring of taxanes.

PubMed

Gerritsen-van Schieveen, Pauline; Royer, Bernard

2011-08-01

Taxanes are anticancer drugs on the market for more than 10 years that are thought to be interesting for therapeutic drug monitoring (TDM): high inter- and intra-patient variability, relationship between exposure and efficacy and especially toxicity. Nevertheless, the paclitaxel and docetaxel characteristics result in different conclusions for these two molecules with respect to their TDM. For paclitaxel, the nonlinear pharmacokinetics makes that the parameter which seems the more reliable to toxicity or outcome is the time during which the plasma concentration exceeds 0.05 μm. Concentration controlled studies using Bayesian adaptation showed that the TDM of paclitaxel is feasible in routine. However, this target needs to be prospectively validated with new weekly schedules of administration, leading to a balance between 'recommended' and 'potentially useful'. For docetaxel, the 3-weekly administration, which is the more effective scheme, is also the more toxic. However, neutropenia can be individually modeled and efficiently predicted without using plasma drug concentrations. The docetaxel TDM using this docetaxel-related neutropenia modeling however needs to be prospectively validated in routine. The level of evidence of TDM thus 'needs to be assessed'. © 2010 The Authors Fundamental and Clinical Pharmacology © 2010 Société Française de Pharmacologie et de Thérapeutique.

A Probabilistic Model for Cushing's Syndrome Screening in At-Risk Populations: A Prospective Multicenter Study.

PubMed

León-Justel, Antonio; Madrazo-Atutxa, Ainara; Alvarez-Rios, Ana I; Infantes-Fontán, Rocio; Garcia-Arnés, Juan A; Lillo-Muñoz, Juan A; Aulinas, Anna; Urgell-Rull, Eulàlia; Boronat, Mauro; Sánchez-de-Abajo, Ana; Fajardo-Montañana, Carmen; Ortuño-Alonso, Mario; Salinas-Vert, Isabel; Granada, Maria L; Cano, David A; Leal-Cerro, Alfonso

2016-10-01

Cushing's syndrome (CS) is challenging to diagnose. Increased prevalence of CS in specific patient populations has been reported, but routine screening for CS remains questionable. To decrease the diagnostic delay and improve disease outcomes, simple new screening methods for CS in at-risk populations are needed. To develop and validate a simple scoring system to predict CS based on clinical signs and an easy-to-use biochemical test. Observational, prospective, multicenter. Referral hospital. A cohort of 353 patients attending endocrinology units for outpatient visits. All patients were evaluated with late-night salivary cortisol (LNSC) and a low-dose dexamethasone suppression test for CS. Diagnosis or exclusion of CS. Twenty-six cases of CS were diagnosed in the cohort. A risk scoring system was developed by logistic regression analysis, and cutoff values were derived from a receiver operating characteristic curve. This risk score included clinical signs and symptoms (muscular atrophy, osteoporosis, and dorsocervical fat pad) and LNSC levels. The estimated area under the receiver operating characteristic curve was 0.93, with a sensitivity of 96.2% and specificity of 82.9%. We developed a risk score to predict CS in an at-risk population. This score may help to identify at-risk patients in non-endocrinological settings such as primary care, but external validation is warranted.

Return to play after thigh muscle injury in elite football players: implementation and validation of the Munich muscle injury classification

PubMed Central

Ekstrand, Jan; Askling, Carl; Magnusson, Henrik; Mithoefer, Kai

2013-01-01

Background Owing to the complexity and heterogeneity of muscle injuries, a generally accepted classification system is still lacking. Aims To prospectively implement and validate a novel muscle injury classification and to evaluate its predictive value for return to professional football. Methods The recently described Munich muscle injury classification was prospectively evaluated in 31 European professional male football teams during the 2011/2012 season. Thigh muscle injury types were recorded by team medical staff and correlated to individual player exposure and resultant time-loss. Results In total, 393 thigh muscle injuries occurred. The muscle classification system was well received with a 100% response rate. Two-thirds of thigh muscle injuries were classified as structural and were associated with longer lay-off times compared to functional muscle disorders (p<0.001). Significant differences were observed between structural injury subgroups (minor partial, moderate partial and complete injuries) with increasing lay-off time associated with more severe structural injury. Median lay-off time of functional disorders was 5–8 days without significant differences between subgroups. There was no significant difference in the absence time between anterior and posterior thigh injuries. Conclusions The Munich muscle classification demonstrates a positive prognostic validity for return to play after thigh muscle injury in professional male football players. Structural injuries are associated with longer average lay-off times than functional muscle disorders. Subclassification of structural injuries correlates with return to play, while subgrouping of functional disorders shows less prognostic relevance. Functional disorders are often underestimated clinically and require further systematic study. PMID:23645834

Why stop self-injuring? Development of the reasons to stop self-injury questionnaire.

PubMed

Turner, Brianna J; Chapman, Alexander L; Gratz, Kim L

2014-01-01

We developed a measure of reasons to refrain from nonsuicidal self-injury (NSSI), the Reasons to Stop Self-Injury Questionnaire (RSSIQ), and examined how such reasons are associated with vulnerability versus resiliency for NSSI. Following qualitative item generation, we explored the factor structure, reliability, and convergent validity of the RSSIQ in 218 self-injuring undergraduates. In Study 2, we confirmed the hierarchical factor structure in 146 self-injuring individuals. In Study 3, we examined the incremental predictive validity of the RSSIQ. These studies resulted in a 40-item inventory with nine subscales and two higher-order factors. Resiliency-related reasons to stop NSSI were associated with greater hopefulness, social support, and adaptive coping, and prospectively protected against NSSI 3 months later, while vulnerability-related reasons were associated with greater psychopathology and dysfunctional coping, and predicted more chronic and severe NSSI. These studies, and the RSSIQ, can enhance the assessment and treatment of NSSI by clarifying motivations to stop NSSI.

Prediction models of donor arrest and graft utilization in liver transplantation from maastricht-3 donors after circulatory death.

PubMed

Davila, D; Ciria, R; Jassem, W; Briceño, J; Littlejohn, W; Vilca-Meléndez, H; Srinivasan, P; Prachalias, A; O'Grady, J; Rela, M; Heaton, N

2012-12-01

Shortage of organs for transplantation has led to the renewed interest in donation after circulatory-determination of death (DCDD). We conducted a retrospective analysis (2001-2009) and a subsequent prospective validation (2010) of liver Maastricht-Category-3-DCDD and donation-after-brain-death (DBD) offers to our program. Accepted and declined offers were compared. Accepted DCDD offers were divided into donors who went on to cardiac arrest and those who did not. Donors who arrested were divided into those producing grafts that were transplanted or remained unused. Descriptive comparisons and regression analyses were performed to assess predictor models of donor cardiac arrest and graft utilization. Variables from the multivariate analysis were prospectively validated. Of 1579 DCDD offers, 621 were accepted, and of these, 400 experienced cardiac arrest after withdrawal of support. Of these, 173 livers were transplanted. In the DCDD group, donor age < 40 years, use of inotropes and absence of gag/cough reflexes were predictors of cardiac arrest. Donor age >50 years, BMI >30, warm ischemia time >25 minutes, ITU stay >7 days and ALT ≥ 4× normal rates were risk factors for not using the graft. These variables had excellent sensitivity and specificity for the prediction of cardiac arrest (AUROC = 0.835) and graft use (AUROC = 0.748) in the 2010 prospective validation. These models can feasibly predict cardiac arrest in potential DCDDs and graft usability, helping to avoid unnecessary recoveries and healthcare expenditure. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

Validation and properties of the verbal numeric scale in children with acute pain.

PubMed

Bailey, Benoit; Daoust, Raoul; Doyon-Trottier, Evelyne; Dauphin-Pierre, Sabine; Gravel, Jocelyn

2010-05-01

Although the verbal numeric scale (VNS) is used frequently at patients' bedsides, it has never been formally validated in children with acute pain. In order to validate this scale, a prospective cohort study was performed in children between 8 and 17years presenting to a pediatric emergency department (ED) with acute pain. Pain was graded using the VNS, the visual analogue scale (VAS), and the verbal rating scale (VRS). A second assessment was done before discharge. We determined a priori that in order to be valid, the VNS would need to: correlate with the VAS (concurrent validity); decrease after intervention to reduce pain (construct validity); and be associated with the VRS categories (content validity). The VNS interchangeability with the VAS, its minimal clinically significant difference, and test-retest reliability were also determined. A total of 202 patients (mean age: 12.2+/-2.6years) were enrolled. The VNS correlated with the VAS: r(ic)=0.93, p<0.001. There were differences in the VNS before versus after interventions (p<0.001), and between VRS categories (mild versus moderate, p<0.001; moderate versus severe, p<0.001). The 95% limits of agreement (interchangeability) between VNS/VAS were outside the a priori set limit of +/-2.0: -1.8, 2.5. The VNS minimal clinically significant difference was 1. The VNS had good test-retest reliability with 95% limits of agreement of -0.9 and 1.2. In conclusion, the VNS provides a valid and reliable scale to evaluate acute pain in children aged 8-17years but is not interchangeable with the VAS. Copyright 2009 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Distorted Beliefs about Luck and Skill and Their Relation to Gambling Problems and Gambling Behavior in Dutch Gamblers.

PubMed

Cowie, Megan E; Stewart, Sherry H; Salmon, Joshua; Collins, Pam; Al-Hamdani, Mohammed; Boffo, Marilisa; Salemink, Elske; de Jong, David; Smits, Ruby; Wiers, Reinout W

2017-01-01

Gamblers' cognitive distortions are thought to be an important mechanism involved in the development and maintenance of problem gambling. The Gambling Cognitions Inventory (GCI) evaluates two categories of distortions: beliefs that one is lucky (i.e., "Luck/Chance") and beliefs that one has special gambling-related skills (i.e., "Skill/Attitude"). Prior psychometric evaluations of the GCI demonstrated the utility of both subscales as measures of distortions and their concurrent relations to gambling problems among Canadian gamblers. However, these associations have not yet been studied in gamblers from other cultures nor have relationships between the GCI and indices of gambling behavior been investigated. In addition, the predictive validity of the GCI scales have not been evaluated in studies to date. The present study investigated the validity of the GCI as a measure of cognitive distortions in a sample of 49 Dutch gamblers by examining its concurrent and prospective relationships to both gambling problems (as measured through a standardized nine-item questionnaire assessing gambling-related problems) and behaviors (as measured through two variables: days spent gambling and time spent gambling in minutes) at baseline and over 1-month and 6-month intervals. The GCI subscales were internally consistent at all timepoints, and moderately to strongly inter-correlated at all timepoints. Each subscale correlated with an independent dimension of gambling both concurrently and prospectively: Luck/Chance was related to greater gambling problems and Skill/Attitude was related to greater gambling behavior . Thus, the two GCI subscales, while inter-correlated, appear to be related to different gambling outcomes, at least among Dutch gamblers. Moreover, the first evidence of the predictive validity of the GCI scales was demonstrated over a 1-month and 6-month interval. It is recommended that both types of cognitive distortions be considered in research and clinical practice to fully understand and address individual risk for excessive and problematic gambling.

Distorted Beliefs about Luck and Skill and Their Relation to Gambling Problems and Gambling Behavior in Dutch Gamblers

PubMed Central

Cowie, Megan E.; Stewart, Sherry H.; Salmon, Joshua; Collins, Pam; Al-Hamdani, Mohammed; Boffo, Marilisa; Salemink, Elske; de Jong, David; Smits, Ruby; Wiers, Reinout W.

2017-01-01

Gamblers’ cognitive distortions are thought to be an important mechanism involved in the development and maintenance of problem gambling. The Gambling Cognitions Inventory (GCI) evaluates two categories of distortions: beliefs that one is lucky (i.e., “Luck/Chance”) and beliefs that one has special gambling-related skills (i.e., “Skill/Attitude”). Prior psychometric evaluations of the GCI demonstrated the utility of both subscales as measures of distortions and their concurrent relations to gambling problems among Canadian gamblers. However, these associations have not yet been studied in gamblers from other cultures nor have relationships between the GCI and indices of gambling behavior been investigated. In addition, the predictive validity of the GCI scales have not been evaluated in studies to date. The present study investigated the validity of the GCI as a measure of cognitive distortions in a sample of 49 Dutch gamblers by examining its concurrent and prospective relationships to both gambling problems (as measured through a standardized nine-item questionnaire assessing gambling-related problems) and behaviors (as measured through two variables: days spent gambling and time spent gambling in minutes) at baseline and over 1-month and 6-month intervals. The GCI subscales were internally consistent at all timepoints, and moderately to strongly inter-correlated at all timepoints. Each subscale correlated with an independent dimension of gambling both concurrently and prospectively: Luck/Chance was related to greater gambling problems and Skill/Attitude was related to greater gambling behavior. Thus, the two GCI subscales, while inter-correlated, appear to be related to different gambling outcomes, at least among Dutch gamblers. Moreover, the first evidence of the predictive validity of the GCI scales was demonstrated over a 1-month and 6-month interval. It is recommended that both types of cognitive distortions be considered in research and clinical practice to fully understand and address individual risk for excessive and problematic gambling. PMID:29312086

Development and validation of the "Pediatric Risk of Nosocomial Sepsis (PRiNS)" score for health care-associated infections in a medical pediatric intensive care unit of a developing economy--a prospective observational cohort study.

PubMed

Saptharishi, L G; Jayashree, Muralidharan; Singhi, Sunit

2016-04-01

Given the high burden of health care-associated infections (HAIs) in resource-limited settings, there is a tendency toward overdiagnosis/treatment. This study was designed to create an easy-to-use, dynamic, bedside risk stratification model for classifying children based on their risk of developing HAIs during their pediatric intensive care unit (PICU) stay, to aid judicious resource utilization. A prospective, observational cohort study was conducted in the 12-bed PICU of a large Indian tertiary care hospital between January and October 2011. A total of 412 consecutive admissions, aged 1 month to 12 years with PICU stay greater than 48 hours were enrolled. Independent predictors for HAIs identified using multivariate regression analysis were combined to create a novel scoring system. Performance and calibration of score were assessed using receiver operating characteristic curves and Hosmer-Lemeshow statistic, respectively. Internal validation was done. Age (<5 years), Pediatric Risk of Mortality III (24 hours) score, presence of indwelling catheters, need for intubation, albumin infusion, immunomodulator, and prior antibiotic use (≥4) were independent predictors of HAIs. This model, with area under the ROC curve of 0.87, at a cutoff of 15, had a negative predictive value of 89.9% with overall accuracy of 79.3%. It reduced classification errors from 29.8% to 20.7%. All 7 predictors retained their statistical significance after bootstrapping, confirming the internal validity of the score. The "Pediatric Risk of Nosocomial Sepsis" score can reliably classify children into high- and low-risk groups, based on their risk of developing HAIs in the PICU of a resource-limited setting. In view of its high sensitivity and specificity, diagnostic and therapeutic interventions may be directed away from the low-risk group, ensuring effective utilization of limited resources. Copyright © 2015 Elsevier Inc. All rights reserved.

Infant and toddler disease score was useful for risk of hospitalization based on data from administrative claims.

PubMed

Mikaeloff, Yann; Moride, Yola; Khoshnood, Babak; Weill, Alain; Bréart, Gérard

2007-07-01

To develop the infant and toddler disease score (IDS), a population-based predictive tool of morbidity status in infants and toddlers, based on data from administrative claims. A prospective cohort study was conducted, including 35,580 children less than 2 years of age in June 2003 from the French "ERASME" database (mean follow-up 13 months). The outcome variable was incident hospitalization during the follow-up year, that is, before the second birthday for infants and before the third for toddlers. Risk factors before inclusion (age, health care use, medications) were assessed in a 50% random sample (construction sample) by a logistic regression model. Beta coefficients were summed up to obtain the IDS. The IDS was then validated for the remaining 50% of the study population (validation sample). The major variables significantly associated with the outcome were long-term disability, younger age, and >or=1 hospitalization before inclusion. The risks of hospitalization estimated by the IDS were concordant in the construction and validation samples. The IDS is a useful index for the risk of hospitalization of infants and toddlers in relation to their morbidity status and may be used for adjustment in pharmacoepidemiologic studies using administrative claims databases.

Failure mode and effects analysis outputs: are they valid?

PubMed

Shebl, Nada Atef; Franklin, Bryony Dean; Barber, Nick

2012-06-10

Failure Mode and Effects Analysis (FMEA) is a prospective risk assessment tool that has been widely used within the aerospace and automotive industries and has been utilised within healthcare since the early 1990s. The aim of this study was to explore the validity of FMEA outputs within a hospital setting in the United Kingdom. Two multidisciplinary teams each conducted an FMEA for the use of vancomycin and gentamicin. Four different validity tests were conducted: Face validity: by comparing the FMEA participants' mapped processes with observational work. Content validity: by presenting the FMEA findings to other healthcare professionals. Criterion validity: by comparing the FMEA findings with data reported on the trust's incident report database. Construct validity: by exploring the relevant mathematical theories involved in calculating the FMEA risk priority number. Face validity was positive as the researcher documented the same processes of care as mapped by the FMEA participants. However, other healthcare professionals identified potential failures missed by the FMEA teams. Furthermore, the FMEA groups failed to include failures related to omitted doses; yet these were the failures most commonly reported in the trust's incident database. Calculating the RPN by multiplying severity, probability and detectability scores was deemed invalid because it is based on calculations that breach the mathematical properties of the scales used. There are significant methodological challenges in validating FMEA. It is a useful tool to aid multidisciplinary groups in mapping and understanding a process of care; however, the results of our study cast doubt on its validity. FMEA teams are likely to need different sources of information, besides their personal experience and knowledge, to identify potential failures. As for FMEA's methodology for scoring failures, there were discrepancies between the teams' estimates and similar incidents reported on the trust's incident database. Furthermore, the concept of multiplying ordinal scales to prioritise failures is mathematically flawed. Until FMEA's validity is further explored, healthcare organisations should not solely depend on their FMEA results to prioritise patient safety issues.

Breathing-synchronised electrical stimulation of the abdominal muscles in patients with acute tetraplegia: A prospective proof-of-concept study.

PubMed

Liebscher, Thomas; Schauer, Thomas; Stephan, Ralph; Prilipp, Erik; Niedeggen, Andreas; Ekkernkamp, Axel; Seidl, Rainer O

2016-11-01

To examine whether, by enhancing breathing depth and expectoration, early use of breathing-synchronised electrical stimulation of the abdominal muscles (abdominal functional electrical stimulation, AFES) is able to reduce pulmonary complications during the acute phase of tetraplegia. Prospective proof-of-concept study. Spinal cord unit at a level 1 trauma center. Following cardiovascular stabilisation, in addition to standard treatments, patients with acute traumatic tetraplegia (ASIA Impairment Scale A or B) underwent breathing-synchronised electrical stimulation of the abdominal muscles to aid expiration and expectoration. The treatment was delivered in 30-minute sessions, twice a day for 90 days. The target was for nine of 15 patients to remain free of pneumonia meeting Centers for Disease Control and Prevention (CDC) diagnostic criteria. Eleven patients were recruited to the study between October 2011 and November 2012. Two patients left the study before completion. None of the patients contracted pneumonia during the study period. No complications from electrical stimulation were observed. AFES led to a statistically significant increase in peak inspiratory and expiratory flows and a non-statistically significant increase in tidal volume and inspiratory and expiratory flow. When surveyed, 6 out of 9 patients (67%) reported that the stimulation procedure led to a significant improvement in breathing and coughing. AFES appears to be able to improve breathing and expectoration and prevent pneumonia in the acute phase of tetraplegia (up to 90 days post-trauma). This result is being validated in a prospective multicentre comparative study.

A Prospective Study Investigating Pre-diagnostic Leukocyte Telomere Length and Risk of Developing Rheumatoid Arthritis in Women

PubMed Central

Prescott, Jennifer; Karlson, Elizabeth W.; Orr, Esther H.; Zee, Robert Y.L.; De Vivo, Immaculata; Costenbader, Karen H.

2015-01-01

Objective To prospectively examine the association between leukocyte telomere length (LTL) and subsequent RA development in women. Methods Using a case-control design nested within the prospective Nurses’ Health Study (NHS), Nurses’ Health Study II (NHSII), and Women’s Health Study (WHS), each validated case of RA with a pre-diagnostic blood sample was matched to three controls by cohort, age, menopausal status, postmenopausal hormone therapy, and blood collection covariates. We measured telomere length in genomic DNA extracted from stored buffy coat samples using quantitative PCR. We used unconditional logistic regression to determine odds ratios (OR) and 95% confidence intervals (CI), and random-effects meta-analysis to combine study results. Results In total, we analyzed 296 incident RA cases and 827 matched controls. Mean age of diagnosis among women who developed RA was 60.5 in NHS/NHSII and 61.3 in WHS. Meta-analysis demonstrated that longer pre-diagnostic LTL was associated with increased RA risk when women in the longest vs. shortest LTL tertile were compared (OR=1.51, 95% CI=1.03–2.23; pheterogeneity=0.27). However, statistically significant between study heterogeneity was observed for the intermediate tertile category (pheterogeneity=0.008). We did not observe heterogeneity by menopausal status, inflammatory cytokine levels, age at diagnosis, age at blood collection, body mass index, seropositivity, or HLA-DRB1 shared epitope status. Conclusion Our results do not support a role for short LTL preceding RA development. PMID:26773113

Investigation of dietary factors and endometrial cancer risk using a nutrient-wide association study approach in the EPIC and Nurses' Health Study (NHS) and NHSII.

PubMed

Merritt, Melissa A; Tzoulaki, Ioanna; Tworoger, Shelley S; De Vivo, Immaculata; Hankinson, Susan E; Fernandes, Judy; Tsilidis, Konstantinos K; Weiderpass, Elisabete; Tjønneland, Anne; Petersen, Kristina E N; Dahm, Christina C; Overvad, Kim; Dossus, Laure; Boutron-Ruault, Marie-Christine; Fagherazzi, Guy; Fortner, Renée T; Kaaks, Rudolf; Aleksandrova, Krasimira; Boeing, Heiner; Trichopoulou, Antonia; Bamia, Christina; Trichopoulos, Dimitrios; Palli, Domenico; Grioni, Sara; Tumino, Rosario; Sacerdote, Carlotta; Mattiello, Amalia; Bueno-de-Mesquita, H Bas; Onland-Moret, N Charlotte; Peeters, Petra H; Gram, Inger T; Skeie, Guri; Quirós, J Ramón; Duell, Eric J; Sánchez, María-José; Salmerón, D; Barricarte, Aurelio; Chamosa, Saioa; Ericson, Ulrica; Sonestedt, Emily; Nilsson, Lena Maria; Idahl, Annika; Khaw, Kay-Tee; Wareham, Nicholas; Travis, Ruth C; Rinaldi, Sabina; Romieu, Isabelle; Patel, Chirag J; Riboli, Elio; Gunter, Marc J

2015-02-01

Data on the role of dietary factors in endometrial cancer development are limited and inconsistent. We applied a "nutrient-wide association study" approach to systematically evaluate dietary risk associations for endometrial cancer while controlling for multiple hypothesis tests using the false discovery rate (FDR) and validating the results in an independent cohort. We evaluated endometrial cancer risk associations for dietary intake of 84 foods and nutrients based on dietary questionnaires in three prospective studies, the European Prospective Investigation into Cancer and Nutrition (EPIC; N = 1,303 cases) followed by validation of nine foods/nutrients (FDR ≤ 0.10) in the Nurses' Health Studies (NHS/NHSII; N = 1,531 cases). Cox regression models were used to estimate HRs and 95% confidence intervals (CI). In multivariate adjusted comparisons of the extreme categories of intake at baseline, coffee was inversely associated with endometrial cancer risk (EPIC, median intake 750 g/day vs. 8.6; HR, 0.81; 95% CI, 0.68-0.97, Ptrend = 0.09; NHS/NHSII, median intake 1067 g/day vs. none; HR, 0.82; 95% CI, 0.70-0.96, Ptrend = 0.04). Eight other dietary factors that were associated with endometrial cancer risk in the EPIC study (total fat, monounsaturated fat, carbohydrates, phosphorus, butter, yogurt, cheese, and potatoes) were not confirmed in the NHS/NHSII. Our findings suggest that coffee intake may be inversely associated with endometrial cancer risk. Further data are needed to confirm these findings and to examine the mechanisms linking coffee intake to endometrial cancer risk to develop improved prevention strategies. ©2015 American Association for Cancer Research.

Accuracy of a Laryngopharyngeal Endoscopic Esthesiometer (LPEER) for Evaluating Laryngopharyngeal Mechanosensitivity: A Validation Study in a Prospectively Recruited Cohort of Patients.

PubMed

Giraldo-Cadavid, Luis F; Burguete, Javier; Rueda, Felipe; Galvis, Ana M; Castaneda, Natalia; Arbulu, Mario; Balaguera, Jorge I; Paez, Nelson; Fernandez, Secundino

2018-02-01

Recent studies have shown an association between alterations in laryngopharyngeal mechanosensitivity (LPMS) and dysphagia, obstructive sleep apnea, and chronic cough hypersensitivity syndrome. A previous reliability study of a new laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER) showed high intra- and inter-rater reliability; however, its accuracy has not been tested. We performed an accuracy study of the LPEER in a prospectively and consecutively recruited cohort of 118 patients at two tertiary care university hospitals. Most of the patients were suffering from dysphagia, and all of them underwent a standard clinical evaluation and fiberoptic endoscopic evaluation of swallowing with sensory testing (FEESST) using a new sensory testing protocol. The sensory test included determinations of the laryngeal adductor reflex threshold (LART), the cough reflex threshold (CRT) and the gag reflex threshold (GRT). Abnormalities on these reflex thresholds were evaluated for associations with major alterations in swallowing safety (pharyngeal residues, penetration, and aspiration). We evaluated the discriminative capacity of the LPMS test using ROC curves and the area under the curve (AUC-ROC) and its relationship with the eight-point penetration-aspiration scale (PAS) using the Spearman's ρ correlation coefficient (SCC). We found a positive correlation between the PAS and LART (SCC 0.47; P < 0.001), CRT (SCC 0.46; P < 0.001) and GRT (SCC 0.34; P = 0.002). The AUC-ROC values for detecting a PAS ≥7 were as follows: LART, 0.83 (P < 0.0001); CRT, 0.79 (P < 0.0001); GRT, 0.72 (P < 0.0001). In this study, the LPEER showed good accuracy for evaluating LPMS. These results justify further validation studies in independent populations.

[Validation of a triage scale: first step in patient admission and in emergency service models].

PubMed

Legrand, A; Thys, F; Vermeiren, E; Touwaide, M; D'Hoore, W; Hubin, V; Reynaert, M S

2003-03-01

At present, most emergency services handle the multitude of various demands in the same unity of place and by the same team of nurses aides, with direct consequences on the waiting time and in the handling of problems of varying degrees of importance. Our service examines other administrative models based on a triage of time and of orientation. In a prospective study on 679 patients, we have validated a triage tool inspired from the ICEM model (International Cooperation of Emergency Medicine) allowing patients to receive, while they wait, information and training, based on the resources provided, in order to deal with their particular medical problem. The validation of this tool was carried out in terms of its utilization as well as its reliability. It appears that, with the type of triage offered, there is a theoretical reserve of waiting time for the patients in which the urgency is relative, and which could be better used in the handling of more vital cases.

Assessing risk for violence among male and female civil psychiatric patients: the HCR-20, PCL:SV, and VSC.

PubMed

Nicholls, Tonia L; Ogloff, James R P; Douglas, Kevin S

2004-01-01

This study evaluated the predictive validity of violence risk assessments conducted using the HCR-20, the Psychopathy Checklist: Screening Version (PCL:SV), and by the Violence Screening Checklist (VSC) in a sample of 268 involuntarily hospitalized male and female psychiatric patients. Information pertaining to violence and crime was coded from medical charts and correctional records. The HCR-20/PCL:SV evidenced modest non-significant associations in postdictive assessments of inpatient violence among men. Moderate to strong significant associations were found between the HCR-20/PCL:SV and inpatient violence among women. Pseudo-prospective assessments using the HCR-20 and PCL:SV resulted in moderate to large relationships with violence and crime in men and women following community discharge. It is concluded that the VSC is a promising tool for assessing acute inpatient violence risk with men. Findings offer preliminary validation of the predictive validity of the HCR-20 and PCL:SV with female civil psychiatric patients. Copyright 2004 John Wiley & Sons, Ltd.

External validation of a simple clinical tool used to predict falls in people with Parkinson disease

PubMed Central

Duncan, Ryan P.; Cavanaugh, James T.; Earhart, Gammon M.; Ellis, Terry D.; Ford, Matthew P.; Foreman, K. Bo; Leddy, Abigail L.; Paul, Serene S.; Canning, Colleen G.; Thackeray, Anne; Dibble, Leland E.

2015-01-01

Background Assessment of fall risk in an individual with Parkinson disease (PD) is a critical yet often time consuming component of patient care. Recently a simple clinical prediction tool based only on fall history in the previous year, freezing of gait in the past month, and gait velocity <1.1 m/s was developed and accurately predicted future falls in a sample of individuals with PD. METHODS We sought to externally validate the utility of the tool by administering it to a different cohort of 171 individuals with PD. Falls were monitored prospectively for 6 months following predictor assessment. RESULTS The tool accurately discriminated future fallers from non-fallers (area under the curve [AUC] = 0.83; 95% CI 0.76 –0.89), comparable to the developmental study. CONCLUSION The results validated the utility of the tool for allowing clinicians to quickly and accurately identify an individual’s risk of an impending fall. PMID:26003412

External validation of a simple clinical tool used to predict falls in people with Parkinson disease.

PubMed

Duncan, Ryan P; Cavanaugh, James T; Earhart, Gammon M; Ellis, Terry D; Ford, Matthew P; Foreman, K Bo; Leddy, Abigail L; Paul, Serene S; Canning, Colleen G; Thackeray, Anne; Dibble, Leland E

2015-08-01

Assessment of fall risk in an individual with Parkinson disease (PD) is a critical yet often time consuming component of patient care. Recently a simple clinical prediction tool based only on fall history in the previous year, freezing of gait in the past month, and gait velocity <1.1 m/s was developed and accurately predicted future falls in a sample of individuals with PD. We sought to externally validate the utility of the tool by administering it to a different cohort of 171 individuals with PD. Falls were monitored prospectively for 6 months following predictor assessment. The tool accurately discriminated future fallers from non-fallers (area under the curve [AUC] = 0.83; 95% CI 0.76-0.89), comparable to the developmental study. The results validated the utility of the tool for allowing clinicians to quickly and accurately identify an individual's risk of an impending fall. Copyright © 2015 Elsevier Ltd. All rights reserved.

Relations Between Autonomous Motivation and Leisure-Time Physical Activity Participation: The Mediating Role of Self-Regulation Techniques.

PubMed

Nurmi, Johanna; Hagger, Martin S; Haukkala, Ari; Araújo-Soares, Vera; Hankonen, Nelli

2016-04-01

This study tested the predictive validity of a multitheory process model in which the effect of autonomous motivation from self-determination theory on physical activity participation is mediated by the adoption of self-regulatory techniques based on control theory. Finnish adolescents (N = 411, aged 17-19) completed a prospective survey including validated measures of the predictors and physical activity, at baseline and after one month (N = 177). A subsample used an accelerometer to objectively measure physical activity and further validate the physical activity self-report assessment tool (n = 44). Autonomous motivation statistically significantly predicted action planning, coping planning, and self-monitoring. Coping planning and self-monitoring mediated the effect of autonomous motivation on physical activity, although self-monitoring was the most prominent. Controlled motivation had no effect on self-regulation techniques or physical activity. Developing interventions that support autonomous motivation for physical activity may foster increased engagement in self-regulation techniques and positively affect physical activity behavior.

A prospective approach to investigating the natural history of preclinical rheumatoid arthritis (RA) using first-degree relatives of probands with RA.

PubMed

Kolfenbach, Jason R; Deane, Kevin D; Derber, Lezlie A; O'Donnell, Colin; Weisman, Michael H; Buckner, Jane H; Gersuk, Vivian H; Wei, Shan; Mikuls, Ted R; O'Dell, James; Gregersen, Peter K; Keating, Richard M; Norris, Jill M; Holers, V Michael

2009-12-15

To describe a large, multicenter prospective cohort study of first-degree relatives (FDRs) of probands with rheumatoid arthritis (RA), and outline the use of such a study in investigating the natural history of RA development. A total of 1,058 FDRs, none of whom met the American College of Rheumatology criteria for RA, were enrolled in a prospective study investigating genetic and environmental influences on the development of RA-related autoimmunity. Demographic, epidemiologic, genetic, autoantibody, and physical examination data from the initial study enrollment visit were described for these FDRs, and the relationship was examined between genetic factors, autoantibodies, inflammation, and joint disease. Fifty-five percent of the FDRs had > or =1 copy of the shared epitope, 20% had > or =1 copy of the PTPN22 polymorphism, and approximately 16% were positive for rheumatoid factor (RF; including isotypes) and/or anti-cyclic citrullinated peptide antibody. IgM-RF positivity is associated with > or =1 tender joint on examination (odds ratio [OR] 2.50, 95% confidence interval [95% CI] 1.27-4.89; P < 0.01) and elevated C-reactive protein (CRP) levels (OR 5.31, 95% CI 1.45-19.52; P = 0.01). FDRs without RA demonstrate high prevalences of genetic risk factors and RA-related autoantibodies. Additionally, an RF association with tender joints and elevated CRP levels suggests that autoantibodies are a valid intermediate marker of RA-related autoimmunity in this cohort. This prospective FDR cohort will be a valuable resource for evaluating the relationship between genetic and epidemiologic factors and the development of RA-related autoimmunity.

Measuring end-of-life care outcomes prospectively.

PubMed

Steinhauser, Karen E

2005-01-01

This paper discusses the state of the science in prospective measurement in end-of-life research and identifies particular areas for focused attention. Topics include defining the scope of inquiry, evaluating experiences of patients too ill to communicate, the role of proxy and family response, measurement sensitivity to change, the role of theory in guiding measurement efforts, evaluating relationships between domains of end-of-life experience, and measurement of cultural comprehensiveness. The state of the sciences calls for future research to (1) conduct longitudinal studies to capture transitions in end-of-life trajectories; (2) evaluate the quality of proxy reporting as it varies by rater relationship, domain, and over time; (3) use state-of-the art psychometric and longitudinal techniques to validate measures and to assess sensitivity to change; (4) develop further and test conceptual models of the experience of dying; (5) study the inter-relatedness of multiple dimensions of end-of-life trajectories; (6) compile updated information evaluating available measurement tools; and (7) conduct population- based research with attention to ethnic and age diversity.

Students’ Cognitive Abilities in Plant Anatomy Practical Work

NASA Astrophysics Data System (ADS)

Setiono, S.; Rustaman, N. Y.; Rahmat, A.; Anggraeni, S.

2017-09-01

Cognitive abilities is fundamental for the students, as it is closely related to higher thinking skills such as the ability to think critically, creatively, and problem solving. This descriptive study aims to investigate the cognitive abilities of biology prospective teachers in the course of Plant Anatomy Practicum based on the cognitive process dimension and dimensions of knowledge the using the framework of Revision of Bloom taxonomy. A number of biology prospective teachers was involved in this study (n=42). The instrument used to collect data for students’ cognitive process mastery in the form of multiple choice with 5 options. Research finding shows that the average student’s cognitive ability is 68.10. The acquisition of knowledge mastery of cognitive ability is still under the criterion of mastery in the course of the Plant Anatomy Practicum (75). Validity and reliability of the instrument (0,71) and (0,81). It is necessary to design lecture programs both in the class and laboratory to develop student’ cognitive abilities.

Validation of the surgical fear questionnaire in adult patients waiting for elective surgery.

PubMed

Theunissen, Maurice; Peters, Madelon L; Schouten, Erik G W; Fiddelers, Audrey A A; Willemsen, Mark G A; Pinto, Patrícia R; Gramke, Hans-Fritz; Marcus, Marco A E

2014-01-01

Because existing instruments for assessing surgical fear seem either too general or too limited, the Surgical Fear Questionnaire (SFQ) was developed. The aim of this study is to assess the validity and reliability of the SFQ. Based on existing literature and expert consultation the ten-item SFQ was composed. Data on the SFQ were obtained from 5 prospective studies (N = 3233) in inpatient or day surgery patients. These data were used for exploratory factor analysis (EFA), confirmatory factor analysis (CFA), reliability analysis and validity analysis. EFA in Study 1 and 2 revealed a two-factor structure with one factor associated with fear of the short-term consequences of surgery (SFQ-s, item 1-4) and the other factor with fear of the long-term consequences of surgery (SFQ-l, item 5-10). However, in both studies two items of the SFQ-l had low factor loadings. Therefore in Study 3 and 4 the 2-factor structure was tested and confirmed by CFA in an eight-item version of the SFQ. Across all studies significant correlations of the SFQ with pain catastrophizing, state anxiety, and preoperative pain intensity indicated good convergent validity. Internal consistency (Cronbach's alpha) was between 0.765-0.920 (SFQ-total), 0.766-0.877 (SFQ-s), and 0.628-0.899 (SFQ-l). The SFQ proved to be sensitive to detect differences based on age, sex, education level, employment status and preoperative pain intensity. The SFQ is a valid and reliable eight-item index of surgical fear consisting of two subscales: fear of the short-term consequences of surgery and fear of the long-term consequences.

Validation of the Spanish version of the Hip Outcome Score: a multicenter study.

PubMed

Seijas, Roberto; Sallent, Andrea; Ruiz-Ibán, Miguel Angel; Ares, Oscar; Marín-Peña, Oliver; Cuéllar, Ricardo; Muriel, Alfonso

2014-05-13

The Hip Outcome Score (HOS) is a self-reported questionnaire evaluating the outcomes of treatment interventions for hip pathologies, divided in 19 items of activities of daily life (ADL) and 9 sports' items. The aim of the present study is to translate and validate HOS into Spanish. A prospective and multicenter study with 100 patients undergoing hip arthroscopy was performed between June 2012 and January 2013. Crosscultural adaptation was used to translate HOS into Spanish. Patients completed the questionnaire before and after surgery. Feasibility, reliability, internal consistency, construct validity (correlation with Western Ontario and McMaster Universities Osteoarthritis Index), ceiling and floor effects and sensitivity to change were assessed for the present study. Mean age was 45.05 years old. 36 women and 64 men were included. Feasibility: 13% had at least one missing item within the ADL subscale and 17% within the sport subscale. Reliability: the translated version of HOS was highly reproducible with intraclass correlation coefficient of 0.95 for ADL and 0.94 for the sports subscale. Internal consistency was confirmed with Cronbach's alpha >0.90 in both subscales. Construct validity showed statistically significant correlation with WOMAC. Ceiling effect was observed in 6% and 12% for ADL and sports subscale, respectively. Floor effect was found in 3% and 37% ADL and sports subscale, respectively. Large sensitivity to change was shown in both subscales. The translated version of HOS into Spanish has shown to be feasible, reliable and sensible to changes for patients undergoing hip arthroscopy. This validated translation of HOS allows for comparisons between studies involving either Spanish- or English-speaking patients. Prognostic study, Level I.

An international prospective cohort study of mobile phone users and health (COSMOS): Factors affecting validity of self-reported mobile phone use.

PubMed

Toledano, Mireille B; Auvinen, Anssi; Tettamanti, Giorgio; Cao, Yang; Feychting, Maria; Ahlbom, Anders; Fremling, Karin; Heinävaara, Sirpa; Kojo, Katja; Knowles, Gemma; Smith, Rachel B; Schüz, Joachim; Johansen, Christoffer; Poulsen, Aslak Harbo; Deltour, Isabelle; Vermeulen, Roel; Kromhout, Hans; Elliott, Paul; Hillert, Lena

2018-01-01

This study investigates validity of self-reported mobile phone use in a subset of 75 993 adults from the COSMOS cohort study. Agreement between self-reported and operator-derived mobile call frequency and duration for a 3-month period was assessed using Cohen's weighted Kappa (κ). Sensitivity and specificity of both self-reported high (≥10 calls/day or ≥4h/week) and low (≤6 calls/week or <30min/week) mobile phone use were calculated, as compared to operator data. For users of one mobile phone, agreement was fair for call frequency (κ=0.35, 95% CI: 0.35, 0.36) and moderate for call duration (κ=0.50, 95% CI: 0.49, 0.50). Self-reported low call frequency and duration demonstrated high sensitivity (87% and 76% respectively), but for high call frequency and duration sensitivity was lower (38% and 56% respectively), reflecting a tendency for greater underestimation than overestimation. Validity of self-reported mobile phone use was lower in women, younger age groups and those reporting symptoms during/shortly after using a mobile phone. This study highlights the ongoing value of using self-report data to measure mobile phone use. Furthermore, compared to continuous scale estimates used by previous studies, categorical response options used in COSMOS appear to improve validity considerably, most likely by preventing unrealistically high estimates from being reported. Copyright © 2017 Elsevier GmbH. All rights reserved.

Use of the Spine Adverse Events Severity System (SAVES) in patients with traumatic spinal cord injury. A comparison with institutional ICD-10 coding for the identification of acute care adverse events.

PubMed

Street, J T; Thorogood, N P; Cheung, A; Noonan, V K; Chen, J; Fisher, C G; Dvorak, M F

2013-06-01

Observational cohort comparison. To compare the previously validated Spine Adverse Events Severity system (SAVES) with International Classification of Diseases, Tenth Revision codes (ICD-10) codes for identifying adverse events (AEs) in patients with traumatic spinal cord injury (TSCI). Quaternary Care Spine Program. Patients discharged between 2006 and 2010 were identified from our prospective registry. Two consecutive cohorts were created based on the system used to record acute care AEs; one used ICD-10 coding by hospital coders and the other used SAVES data prospectively collected by a multidisciplinary clinical team. The ICD-10 codes were appropriately mapped to the SAVES. There were 212 patients in the ICD-10 cohort and 173 patients in the SAVES cohort. Analyses were adjusted to account for the different sample sizes, and the two cohorts were comparable based on age, gender and motor score. The SAVES system identified twice as many AEs per person as ICD-10 coding. Fifteen unique AEs were more reliably identified using SAVES, including neuropathic pain (32 × more; P<0.001), urinary tract infections (1.4 × ; P<0.05), pressure sores (2.9 × ; P<0.001) and intra-operative AEs (2.3 × ; P<0.05). Eight of these 15 AEs more frequently identified by SAVES significantly impacted length of stay (P<0.05). Risk factors such as patient age and severity of paralysis were more reliably correlated to AEs collected through SAVES than ICD-10. Implementation of the SAVES system for patients with TSCI captured more individuals experiencing AEs and more AEs per person compared with ICD-10 codes. This study demonstrates the utility of prospectively collecting AE data using validated tools.

Factors associated with exercise adherence among older adults. An individual perspective.

PubMed

Rhodes, R E; Martin, A D; Taunton, J E; Rhodes, E C; Donnelly, M; Elliot, J

1999-12-01

This paper reviews the literature concerning factors at the individual level associated with regular exercise among older adults. Twenty-seven cross-sectional and 14 prospective/longitudinal studies met the inclusion criteria of a mean participant age of 65 years or older. The findings are summarised by demographics, exercise experience, exercise knowledge, physiological factors, psychological factors, activity preferences and perceived social influences. In general, education and exercise history correlate positively with regular exercise, while perceived physical frailty and poor health may provide the greatest barrier to exercise adoption and adherence in the elderly. Social-cognitive theories identify several constructs that correlate with the regular exercise behaviour of older adults, such as exercise attitude, perceived behavioural control/self-efficacy, perceived social support and perceived benefits/barriers to continued activity. As well, stage modelling may provide additional information about the readiness for regular exercise behaviour among older adults. However, relatively few studies among older adults exist compared with middle-aged and younger adults. Further, the majority of current research consists of cross-sectional designs or short prospective exercise trials among motivated volunteers that may lack external validity. Future research utilising longitudinal and prospective designs with representative samples of older adults will provide a better understanding of significant causal associations between individual factors and regular exercise behaviour.

Impact of Net Atrioventricular Compliance on Clinical Outcome in Mitral Stenosis

PubMed Central

Nunes, Maria Carmo P.; Hung, Judy; Barbosa, Marcia M.; Esteves, William A.; Carvalho, Vinicius T.; Lodi-Junqueira, Lucas; Fonseca Neto, Cirilo P.; Tan, Timothy C.; Levine, Robert A.

2014-01-01

Background Net atrioventricular compliance (Cn) has been reported to be an important determinant of pulmonary hypertension in mitral stenosis (MS). We hypothesized that, as Cn reflects hemodynamic consequences of MS, it may be useful in assessing prognosis. To date, limited data with an assumed Cn cutoff have indicated the need for larger prospective studies. This prospective study was designed to determine the impact of Cn on clinical outcome and its contribution to pulmonary pressure in MS. In addition, we aimed to identify a cutoff value of Cn for outcome prediction in this setting. Methods and Results A total of 128 patients with rheumatic MS without other significant valve disease were prospectively enrolled. Comprehensive echocardiography was performed and Doppler-derived Cn estimated using a previously validated equation. The endpoint was either mitral valve intervention or death. Cn was an important predictor of pulmonary pressure, regardless of classic measures of MS severity. During a median follow-up of 22 months, the endpoint was reached in 45 patients (35%). Baseline Cn predicted outcome, adding prognostic information beyond that provided by mitral valve area and functional status. Cn ≤ 4 mL/mmHg best predicted unfavorable outcome in derivation and validation sets. A subgroup analysis including only initially asymptomatic patients with moderate to severe MS without initial indication for intervention (40.6 % of total) demonstrated that baseline Cn predicted subsequent adverse outcome even after adjusting for classic measures of hemodynamic MS severity (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.14–0.79, p = 0.013). Conclusions Cn contributes to pulmonary hypertension beyond of stenosis severity itself. In a wide spectrum of MS severity, Cn is a powerful predictor of adverse outcome, adding prognostic value to clinical data and mitral valve area. Importantly, baseline Cn predicts a progressive course with subsequent need for intervention in initially asymptomatic patients. Cn assessment therefore has potential value for clinical risk stratification and monitoring in MS patients. PMID:24097419

Electrical Systems Analysis at NASA Glenn Research Center: Status and Prospects

NASA Technical Reports Server (NTRS)

Freeh, Joshua E.; Liang, Anita D.; Berton, Jeffrey J.; Wickenheiser, Timothy J.

2003-01-01

An analysis of an electrical power and propulsion system for a 2-place general aviation aircraft is presented to provide a status of such modeling at NASA Glenn Research Center. The thermodynamic/ electrical model and mass prediction tools are described and the resulting system power and mass are shown. Three technology levels are used to predict the effect of advancements in component technology. Methods of fuel storage are compared by mass and volume. Prospects for future model development and validation at NASA as well as possible applications are also summarized.

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

PubMed

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

2016-08-09

Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III). ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Application of Data-Driven Evidential Belief Functions to Prospectivity Mapping for Aquamarine-Bearing Pegmatites, Lundazi District, Zambia

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

Carranza, E. J. M., E-mail: carranza@itc.nl; Woldai, T.; Chikambwe, E. M.

A case application of data-driven estimation of evidential belief functions (EBFs) is demonstrated to prospectivity mapping in Lundazi district (eastern Zambia). Spatial data used to represent recognition criteria of prospectivity for aquamarine-bearing pegmatites include mapped granites, mapped faults/fractures, mapped shear zones, and radioelement concentration ratios derived from gridded airborne radiometric data. Data-driven estimates EBFs take into account not only (a) spatial association between an evidential map layer and target deposits but also (b) spatial relationships between classes of evidences in an evidential map layer. Data-driven estimates of EBFs can indicate which spatial data provide positive or negative evidence of prospectivity.more » Data-driven estimates of EBFs of only spatial data providing positive evidence of prospectivity were integrated according to Dempster's rule of combination. Map of integrated degrees of belief was used to delineate zones of relative degress of prospectivity for aquamarine-bearing pegmatites. The predictive map has at least 85% prediction rate and at least 79% success rate of delineating training and validation deposits, respectively. The results illustrate usefulness of data-driven estimation of EBFs in GIS-based predictive mapping of mineral prospectivity. The results also show usefulness of EBFs in managing uncertainties associated with evidential maps.« less

Development and validation of a predictive model for 90-day readmission following elective spine surgery.

PubMed

Parker, Scott L; Sivaganesan, Ahilan; Chotai, Silky; McGirt, Matthew J; Asher, Anthony L; Devin, Clinton J

2018-06-15

OBJECTIVE Hospital readmissions lead to a significant increase in the total cost of care in patients undergoing elective spine surgery. Understanding factors associated with an increased risk of postoperative readmission could facilitate a reduction in such occurrences. The aims of this study were to develop and validate a predictive model for 90-day hospital readmission following elective spine surgery. METHODS All patients undergoing elective spine surgery for degenerative disease were enrolled in a prospective longitudinal registry. All 90-day readmissions were prospectively recorded. For predictive modeling, all covariates were selected by choosing those variables that were significantly associated with readmission and by incorporating other relevant variables based on clinical intuition and the Akaike information criterion. Eighty percent of the sample was randomly selected for model development and 20% for model validation. Multiple logistic regression analysis was performed with Bayesian model averaging (BMA) to model the odds of 90-day readmission. Goodness of fit was assessed via the C-statistic, that is, the area under the receiver operating characteristic curve (AUC), using the training data set. Discrimination (predictive performance) was assessed using the C-statistic, as applied to the 20% validation data set. RESULTS A total of 2803 consecutive patients were enrolled in the registry, and their data were analyzed for this study. Of this cohort, 227 (8.1%) patients were readmitted to the hospital (for any cause) within 90 days postoperatively. Variables significantly associated with an increased risk of readmission were as follows (OR [95% CI]): lumbar surgery 1.8 [1.1-2.8], government-issued insurance 2.0 [1.4-3.0], hypertension 2.1 [1.4-3.3], prior myocardial infarction 2.2 [1.2-3.8], diabetes 2.5 [1.7-3.7], and coagulation disorder 3.1 [1.6-5.8]. These variables, in addition to others determined a priori to be clinically relevant, comprised 32 inputs in the predictive model constructed using BMA. The AUC value for the training data set was 0.77 for model development and 0.76 for model validation. CONCLUSIONS Identification of high-risk patients is feasible with the novel predictive model presented herein. Appropriate allocation of resources to reduce the postoperative incidence of readmission may reduce the readmission rate and the associated health care costs.

[Prognostic scores for pulmonary embolism].

PubMed

Junod, Alain

2016-03-23

Nine prognostic scores for pulmonary embolism (PE), based on retrospective and prospective studies, published between 2000 and 2014, have been analyzed and compared. Most of them aim at identifying PE cases with a low risk to validate their ambulatory care. Important differences in the considered outcomes: global mortality, PE-specific mortality, other complications, sizes of low risk groups, exist between these scores. The most popular score appears to be the PESI and its simplified version. Few good quality studies have tested the applicability of these scores to PE outpatient care, although this approach tends to already generalize in the medical practice.

Childhood Vascular Tumors Treatment (PDQ®)—Health Professional Version

Cancer.gov

Treatment options for children with vascular tumors are limited and efficacy has not been validated in prospective clinical trials. Historically therapies have been mostly to palliate symptoms. Get detailed information about the types of vascular tumors in this clinician summary.

76 FR 1138 - Enhanced Assessment Instruments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

... priorities: (a) Collaborating with institutions of higher education, other research institutions, or other... a member State may hold); (2) The consortium's method and process (e.g., consensus, majority) for... available on an ongoing basis for research, including for prospective linking, validity, and program...

23 CFR 1327.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of an individual's driver record, used in the American Association of Motor Vehicle Administrators... authorities. Also known as Motor Vehicle Record (MVR) or Transcript. (e) Driver licensing purposes means... holds a valid license. (g) Employers or prospective employers of motor vehicle operators means persons...

23 CFR 1327.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... of an individual's driver record, used in the American Association of Motor Vehicle Administrators... authorities. Also known as Motor Vehicle Record (MVR) or Transcript. (e) Driver licensing purposes means... holds a valid license. (g) Employers or prospective employers of motor vehicle operators means persons...

23 CFR 1327.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... of an individual's driver record, used in the American Association of Motor Vehicle Administrators... authorities. Also known as Motor Vehicle Record (MVR) or Transcript. (e) Driver licensing purposes means... holds a valid license. (g) Employers or prospective employers of motor vehicle operators means persons...

A systematic review of reliable and valid tools for the measurement of patient participation in healthcare.

PubMed

Phillips, Nicole Margaret; Street, Maryann; Haesler, Emily

2016-02-01

Patient participation in healthcare is recognised internationally as essential for consumer-centric, high-quality healthcare delivery. Its measurement as part of continuous quality improvement requires development of agreed standards and measurable indicators. This systematic review sought to identify strategies to measure patient participation in healthcare and to report their reliability and validity. In the context of this review, patient participation was constructed as shared decision-making, acknowledging the patient as having critical knowledge regarding their own health and care needs and promoting self-care/autonomy. Following a comprehensive search, studies reporting reliability or validity of an instrument used in a healthcare setting to measure patient participation, published in English between January 2004 and March 2014 were eligible for inclusion. From an initial search, which identified 1582 studies, 156 studies were retrieved and screened against inclusion criteria. Thirty-three studies reporting 24 patient participation measurement tools met inclusion criteria, and were critically appraised. The majority of studies were descriptive psychometric studies using prospective, cross-sectional designs. Almost all the tools completed by patients, family caregivers, observers or more than one stakeholder focused on aspects of patient-professional communication. Few tools designed for completion by patients or family caregivers provided valid and reliable measures of patient participation. There was low correlation between many of the tools and other measures of patient satisfaction. Few reliable and valid tools for measurement of patient participation in healthcare have been recently developed. Of those reported in this review, the dyadic Observing Patient Involvement in Decision Making (dyadic-OPTION) tool presents the most promise for measuring core components of patient participation. There remains a need for further study into valid, reliable and feasible strategies for measuring patient participation as part of continuous quality improvement. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cryotherapy for primary treatment of prostate cancer: intermediate term results of a prospective study from a single institution.

PubMed

Rodríguez, S Alvarez; Arias Fúnez, F; Bueno Bravo, C; Rodríguez-Patrón Rodríguez, R; Sanz Mayayo, E; Palacios, V Hevia; Burgos Revilla, F J

2014-01-01

Purpose. Published data about cryotherapy for prostate cancer (PC) treatment are based on case series with a lack of clinical trials and the inexistence of a validated definition of biochemical failure. A prospective study with standardized followup protocol was conducted in our institution. Material and Methods. Prospective study of a series of cases including 108 patients diagnosed with localized PC at clinical stage T1c-T2c treated by primary cryoablation and median followup of 61 months. Criteria of biochemical recurrence were unified according to the American Society for Therapeutic Radiology and Oncology (ASTRO). End points were biochemical progression-free survival (BPFS), cancer-specific survival, and overall survival. Rate of complications was reported. Results. The BPFS for low-, medium-, and high-risk patients was 96.4%, 91.2%, and 62.2%, respectively. Cancer-specific survival was 98.1%. Overall survival reached 94.4%. Complications included incontinence in 5.6%, urinary tract obstruction in 1.9%, urethral sloughing in 5.6%, haematuria in 1.9%, perineal pain in 11.1%, and prostatorectal fistula in 0.9%. Erectile disfunction was found in 98.1%. Conclusions. Cryotherapy is an effective and minimally invasive treatment for primary PC in well-selected cases, with low surgical risk and good results in terms of BPFS, cancer-specific survival, and overall survival.

Cryotherapy for Primary Treatment of Prostate Cancer: Intermediate Term Results of a Prospective Study from a Single Institution

PubMed Central

Rodríguez, S. Alvarez; Arias Fúnez, F.; Bueno Bravo, C.; Rodríguez-Patrón Rodríguez, R.; Sanz Mayayo, E.; Palacios, V. Hevia; Burgos Revilla, F. J.

2014-01-01

Purpose. Published data about cryotherapy for prostate cancer (PC) treatment are based on case series with a lack of clinical trials and the inexistence of a validated definition of biochemical failure. A prospective study with standardized followup protocol was conducted in our institution. Material and Methods. Prospective study of a series of cases including 108 patients diagnosed with localized PC at clinical stage T1c-T2c treated by primary cryoablation and median followup of 61 months. Criteria of biochemical recurrence were unified according to the American Society for Therapeutic Radiology and Oncology (ASTRO). End points were biochemical progression-free survival (BPFS), cancer-specific survival, and overall survival. Rate of complications was reported. Results. The BPFS for low-, medium-, and high-risk patients was 96.4%, 91.2%, and 62.2%, respectively. Cancer-specific survival was 98.1%. Overall survival reached 94.4%. Complications included incontinence in 5.6%, urinary tract obstruction in 1.9%, urethral sloughing in 5.6%, haematuria in 1.9%, perineal pain in 11.1%, and prostatorectal fistula in 0.9%. Erectile disfunction was found in 98.1%. Conclusions. Cryotherapy is an effective and minimally invasive treatment for primary PC in well-selected cases, with low surgical risk and good results in terms of BPFS, cancer-specific survival, and overall survival. PMID:24693437

Prediction of aortic valvular area and gradient by noninvasive techniques.

PubMed

Cousins, A L; Eddleman, E E; Reeves, T J

1978-03-01

Sixty-two patients with isolated aortic valvular stenosis were analyzed by a series of common noninvasive procedures and by cardiac catheterization. The data from 50 of these were evaluated in a retrospective fashion by multiple regression methods to determine significant objectively obtained predictors of aortic-left ventricular gradient and valvular area. Formulae were derived from these analyses and an additional 12 patients were then studied prospectively to evaluate the validity of the predictive formulae. Forty-three of 50 patients (86 per cent) were correctly identified as to a gradient of greater or less than 50 mm. Hg in the initial group, and all those in the prospectively studied sample were correctly classified. Thiry-five of 43 patients (82 per cent) of those with valve area data in the first application were correctly classified as to valve area or greater or less than 0.8 cm.2, and all patients in the prospectively studied group were appropriately identified as to the same area. The combined application of the observations of calcification of the aortic valve, shudder waves on the anacrotic limb, prolonged time to peak of the percussion wave and alteration of the dicrotic notch of the carotid pulse tracing, left ventricular hypertrophy by electrocardiogram, and the altered duration of ventricular ejection time were reliable predictors of elevated aortic-left ventricular gradient and decreased aortic valvular size.

Targeted Proteomics Predicts a Sustained Complete-Response after Transarterial Chemoembolization and Clinical Outcomes in Patients with Hepatocellular Carcinoma: A Prospective Cohort Study.

PubMed

Yu, Su Jong; Kim, Hyunsoo; Min, Hophil; Sohn, Areum; Cho, Young Youn; Yoo, Jeong-Ju; Lee, Dong Hyeon; Cho, Eun Ju; Lee, Jeong-Hoon; Gim, Jungsoo; Park, Taesung; Kim, Yoon Jun; Kim, Chung Yong; Yoon, Jung-Hwan; Kim, Youngsoo

2017-03-03

This study was aimed to identify blood-based biomarkers to predict a sustained complete response (CR) after transarterial chemoembolization (TACE) using targeted proteomics. Consecutive patients with HCC who had undergone TACE were prospectively enrolled (training (n = 100) and validation set (n = 80)). Serum samples were obtained before and 6 months after TACE. Treatment responses were evaluated using the modified Response Evaluation Criteria in Solid Tumors (mRECIST). In the training set, the MRM-MS assay identified five marker candidate proteins (LRG1, APCS, BCHE, C7, and FCN3). When this five-marker panel was combined with the best-performing clinical variables (tumor number, baseline PIVKA, and baseline AFP), the resulting ensemble model had the highest area under the receiver operating curve (AUROC) value in predicting a sustained CR after TACE in the training and validation sets (0.881 and 0.813, respectively). Furthermore, the ensemble model was an independent predictor of rapid progression (hazard ratio (HR), 2.889; 95% confidence interval (CI), 1.612-5.178; P value < 0.001) and overall an unfavorable survival rate (HR, 1.985; 95% CI, 1.024-3.848; P value = 0.042) in the entire population by multivariate analysis. Targeted proteomics-based ensemble model can predict clinical outcomes after TACE. Therefore, this model can aid in determining the best candidates for TACE and the need for adjuvant therapy.

Evaluation of recruitment and selection for specialty training in public health: interim results of a prospective cohort study to measure the predictive validity of the selection process.

PubMed

Pashayan, Nora; Gray, Selena; Duff, Celia; Parkes, Julie; Williams, David; Patterson, Fiona; Koczwara, Anna; Fisher, Grant; Mason, Brendan W

2016-06-01

The recruitment process for public health specialty training includes an assessment centre (AC) with three components, Rust Advanced Numerical Reasoning Appraisal (RANRA), Watson-Glaser Critical Thinking Appraisal (WGCT) and a Situation Judgement Test (SJT), which determines invitation to a selection centre (SC). The scores are combined into a total recruitment (TR) score that determines the offers of appointment. A prospective cohort study using anonymous record linkage to investigate the association between applicant's scores in the recruitment process and registrar's progress through training measured by results of Membership Faculty Public Health (MFPH) examinations and outcomes of the Annual Review of Competence Progression (ARCP). Higher scores in RANRA, WGCT, AC, SC and TR were all significantly associated with higher adjusted odds of passing Part A MFPH exam at the first attempt. Higher scores in AC, SC and TR were significantly associated with passing Part B exam at the first attempt. Higher scores in SJT, AC and SC were significantly associated with satisfactory ARCP outcomes. The current UK national recruitment and selection process for public health specialty training has good predictive validity. The individual components of the process are testing different skills and abilities and together they are providing additive value. © The Author 2015. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Prospective memory function and cue salience in mild cognitive impairment: Findings from the Sydney Memory and Ageing Study.

PubMed

Thompson, Claire L; Henry, Julie D; Rendell, Peter G; Withall, Adrienne; Kochan, Nicole A; Sachdev, Perminder; Brodaty, Henry

2017-12-01

Prospective memory (PM) is crucial to the maintenance of functional independence in late adulthood and is consistently impaired in mild cognitive impairment (MCI). There remains a need for brief but valid measures of this construct that can be used as part of a comprehensive clinical assessment of cognition. Since the distinctiveness of PM cues is argued to determine the degree of strategic, controlled demands of PM paradigms, two variants of a brief measure were developed, one of which presented low-salience and the other high-salience PM cues. A large cohort of older adults with normal cognition or MCI was assessed with one of the two variants of our brief, novel measure of PM. Participants were asked to remember to execute PM tasks where the target cue was either high or low in salience, while concurrently engaged in an ongoing task of olfactory assessment. The task was able to discriminate between groups of participants with MCI or no cognitive impairment, albeit with a small effect size. The high-salience cue improved performance on the PM task; however, there was no interaction of cue salience with group. These results suggest that the temporal reliability and construct validity of very brief measures of the type used in this study need further exploration to determine their potential to provide meaningful insights into PM function. This measure may have utility as a brief screening tool, with identified deficits being followed up with a more comprehensive PM assessment.

Generalizing disease management program results: how to get from here to there.

PubMed

Linden, Ariel; Adams, John L; Roberts, Nancy

2004-07-01

For a disease management (DM) program, the ability to generalize results from the intervention group to the population, to other populations, or to other diseases is as important as demonstrating internal validity. This article provides an overview of the threats to external validity of DM programs, and offers methods to improve the capability for generalizing results obtained through the program. The external validity of DM programs must be evaluated even before program selection and implementation are begun with a prospective new client. Any fundamental differences in characteristics between individuals in an established DM program and in a new population/environment may limit the ability to generalize.

[Preoperative risk assessment with the ASA classification. A prospective study of morbidity and mortality in various ASA classes in 2,937 patients in general surgery].

PubMed

Menke, H; John, K D; Klein, A; Lorenz, W; Junginger, T

1992-12-01

The value of ASA classification in assessment of perioperative risk, i.e. especially postoperative morbidity, was analyzed prospectively using the data of 2937 patients. The analysis took into account the criteria validity, reliability, and sensitivity. The incidence of post-operative morbidity after elective surgery rose from 3.9% in ASA class I to 36% in ASA class IV. Mortality was 0.6% in ASA class II, whereas 9.3% died in ASA class IV. Morbidity, mortality respectively, after emergency surgery was 10.2% in ASA class II compared to 69% in class IV, mortality 1.4% compared to 21.5%. Differences between the ASA classes were confirmed (p-value < 0.05) considering separate kinds of complications and different periods. Furthermore, ASA classification was a valuable reference to length of stay and severity of necessary therapy at the ICU.

Evidence on existing caries risk assessment systems: are they predictive of future caries?

PubMed

Tellez, M; Gomez, J; Pretty, I; Ellwood, R; Ismail, A I

2013-02-01

To critically appraise evidence for the prediction of caries using four caries risk assessment (CRA) systems/guidelines (Cariogram, Caries Management by Risk Assessment (CAMBRA), American Dental Association (ADA), and American Academy of Pediatric Dentistry (AAPD)). This review focused on prospective cohort studies or randomized controlled trials. A systematic search strategy was developed to locate papers published in Medline Ovid and Cochrane databases. The search identified 539 scientific reports, and after title and abstract review, 137 were selected for full review and 14 met the following inclusion criteria: (i) used as validating criterion caries incidence/increment, (ii) involved human subjects and natural carious lesions, and (iii) published in peer-reviewed journals. In addition, papers were excluded if they met one or more of the following criteria: (i) incomplete description of sample selection, outcomes, or small sample size and (ii) not meeting the criteria for best evidence under the prognosis category of the Oxford Centre for Evidence-Based Medicine. There are wide variations among the systems in terms of definitions of caries risk categories, type and number of risk factors/markers, and disease indicators. The Cariogram combined sensitivity and specificity for predicting caries in permanent dentition ranges from 110 to 139 and is the only system for which prospective studies have been conducted to assess its validity. The Cariogram had limited prediction utility in preschool children, and a moderate to good performance for sorting out elderly individuals into caries risk groups. One retrospective analysis on CAMBRA's CRA reported higher incidence of cavitated lesions among those assessed as extreme-risk patients when compared with those at low risk. The evidence on the validity for existing systems for CRA is limited. It is unknown if the identification of high-risk individuals can lead to more effective long-term patient management that prevents caries initiation and arrests or reverses the progression of lesions. There is an urgent need to develop valid and reliable methods for caries risk assessment that are based on best evidence for prediction and disease management rather than opinions of experts.

Psychometric properties of the Compulsive Exercise Test in an adolescent eating disorder population.

PubMed

Formby, Pam; Watson, Hunna J; Hilyard, Anna; Martin, Kate; Egan, Sarah J

2014-12-01

The objective of this study was to evaluate the factor structure, validity, and reliability of the Compulsive Exercise Test (CET) in an adolescent clinical eating disorder population. The data source was the Helping to Outline Paediatric Eating Disorders (HOPE) Project, a prospective ongoing registry study comprising consecutive pediatric tertiary eating disorder referrals. Adolescents (N=104; 12-17years) with eating disorders completed the CET and other measures. Factor structure, convergent validity, and internal consistency were evaluated. Despite failing to identify a factor structure, the study provided clear evidence of the multidimensionality of the measure. The total score correlated significantly with measures of eating pathology, perfectionism, and frequency of exercise for shape and weight control (r=0.32-0.70, ps<0.05). More research into the multidimensional nature of compulsive exercise in clinical populations is needed. Further, research into compulsive exercise offers promise as an addition to existing cognitive behavioral models and treatments for eating disorders. Copyright © 2014 Elsevier Ltd. All rights reserved.

Validation of the cephalosporin intradermal skin test for predicting immediate hypersensitivity: a prospective study with drug challenge.

PubMed

Yoon, S-Y; Park, S Y; Kim, S; Lee, T; Lee, Y S; Kwon, H-S; Cho, Y S; Moon, H-B; Kim, T-B

2013-07-01

Cephalosporin is a major offending agent in terms of drug hypersensitivity along with penicillin. Cephalosporin intradermal skin tests (IDTs) have been widely used; however, their validity for predicting immediate hypersensitivity has not been studied. This study aimed to determine the predictive value of cephalosporin intradermal skin testing before administration of the drug. We prospectively conducted IDTs with four cephalosporins, one each of selected first-, second-, third-, or fourth-generation cephalosporins: ceftezol; cefotetan or cefamandole; ceftriaxone or cefotaxime; and flomoxef, respectively, as well as with penicillin G. After the skin test, whatever the result, one of the tested cephalosporins was administered intravenously and the patient was carefully observed. We recruited 1421 patients who required preoperative cephalosporins. Seventy-four patients (74/1421, 5.2%) were positive to at least one cephalosporin. However, none of responders had immediate hypersensitivity reactions after a challenge dose of the same or different cephalosporin, which were positive in the skin test. Four patients who suffered generalized urticaria and itching after challenge gave negative skin tests for the corresponding drug. The IDT for cephalosporin had a sensitivity of 0%, a specificity of 97.5%, a negative predictive value of 99.7%, and a positive predictive value (PPV) of 0%, when challenged with the same drugs that were positive in the skin test. Routine skin testing with a cephalosporin before its administration is not useful for predicting immediate hypersensitivity because of the extremely low sensitivity and PPV of the skin test (CRIS registration no. KCT0000455). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Preoperative predictive model for acute kidney injury after elective cardiac surgery: a prospective multicentre cohort study.

PubMed

Callejas, Raquel; Panadero, Alfredo; Vives, Marc; Duque, Paula; Echarri, Gemma; Monedero, Pablo

2018-05-11

Predictive models of CS-AKI include emergency surgery and patients with haemodynamic instability. Our objective was to evaluate the performance of validated predictive models (Thakar and Demirjian) in elective cardiac surgery and to propose a better score in the case of poor performance. A prospective, multicentre, observational study was designed. Data were collected from 942 patients undergoing cardiac surgery, after excluding emergency surgery and patients with an intraaortic balloon pump. The main outcome measure was CS-AKI defined by the composite of requiring dialysis or doubling baseline creatinine values. Both models showed poor discrimination in elective surgery (Thakar's model, AUROC = 0.57, 95% CI = 0.50-0.64 and Demirjian's model, AUROC= 0.64, 95% CI = 0.58-0.71). We generated a new model whose significant independent predictors were: anaemia, age, hypertension, obesity, congestive heart failure, previous cardiac surgery and type of surgery. It classifies patients with scores 0-3 as low risk (< 5%), scores 4-7 as medium risk (up to 15%) and scores > 8 as high risk (>30%) of developing CS-AKI with a statistically significant correlation (p <0.001). Our model reflects acceptable discriminatory ability (AUC = 0.72, 95% CI = 0.66-0.78) which is significantly better than Thakar and Demirjian's models (p<0.01). We developed a new simple predictive model of CS-AKI in elective surgery based on available preoperative information. Our new model is easy to calculate and can be an effective tool for communicating risk to patients and guiding decision-making in the perioperative period. The study requires external validation.

Validation of the CAchexia SCOre (CASCO). Staging Cancer Patients: The Use of miniCASCO as a Simplified Tool

PubMed Central

Argilés, Josep M.; Betancourt, Angelica; Guàrdia-Olmos, Joan; Peró-Cebollero, Maribel; López-Soriano, Francisco J.; Madeddu, Clelia; Serpe, Roberto; Busquets, Sílvia

2017-01-01

The CAchexia SCOre (CASCO) was described as a tool for the staging of cachectic cancer patients. The aim of this study is to show the metric properties of CASCO in order to classify cachectic cancer patients into three different groups, which are associated with a numerical scoring. The final aim was to clinically validate CASCO for its use in the classification of cachectic cancer patients in clinical practice. We carried out a case -control study that enrolled prospectively 186 cancer patients and 95 age-matched controls. The score includes five components: (1) body weight loss and composition, (2) inflammation/metabolic disturbances/immunosuppression, (3) physical performance, (4) anorexia, and (5) quality of life. The present study provides clinical validation for the use of the score. In order to show the metric properties of CASCO, three different groups of cachectic cancer patients were established according to the results obtained with the statistical approach used: mild cachexia (15 ≤ × ≤ 28), moderate cachexia (29 ≤ × ≤ 46), and severe cachexia (47 ≤ × ≤ 100). In addition, a simplified version of CASCO, MiniCASCO (MCASCO), was also presented and it contributes as a valid and easy-to-use tool for cachexia staging. Significant statistically correlations were found between CASCO and other validated indexes such as Eastern Cooperative Oncology Group (ECOG) and the subjective diagnosis of cachexia by specialized oncologists. A very significant estimated correlation between CASCO and MCASCO was found that suggests that MCASCO might constitute an easy and valid tool for the staging of the cachectic cancer patients. CASCO and MCASCO provide a new tool for the quantitative staging of cachectic cancer patients with a clear advantage over previous classifications. PMID:28261113

Validation of the CAchexia SCOre (CASCO). Staging Cancer Patients: The Use of miniCASCO as a Simplified Tool.

PubMed

Argilés, Josep M; Betancourt, Angelica; Guàrdia-Olmos, Joan; Peró-Cebollero, Maribel; López-Soriano, Francisco J; Madeddu, Clelia; Serpe, Roberto; Busquets, Sílvia

2017-01-01

The CAchexia SCOre (CASCO) was described as a tool for the staging of cachectic cancer patients. The aim of this study is to show the metric properties of CASCO in order to classify cachectic cancer patients into three different groups, which are associated with a numerical scoring. The final aim was to clinically validate CASCO for its use in the classification of cachectic cancer patients in clinical practice. We carried out a case -control study that enrolled prospectively 186 cancer patients and 95 age-matched controls. The score includes five components: (1) body weight loss and composition, (2) inflammation/metabolic disturbances/immunosuppression, (3) physical performance, (4) anorexia, and (5) quality of life. The present study provides clinical validation for the use of the score. In order to show the metric properties of CASCO, three different groups of cachectic cancer patients were established according to the results obtained with the statistical approach used: mild cachexia (15 ≤ × ≤ 28), moderate cachexia (29 ≤ × ≤ 46), and severe cachexia (47 ≤ × ≤ 100). In addition, a simplified version of CASCO, MiniCASCO (MCASCO), was also presented and it contributes as a valid and easy-to-use tool for cachexia staging. Significant statistically correlations were found between CASCO and other validated indexes such as Eastern Cooperative Oncology Group (ECOG) and the subjective diagnosis of cachexia by specialized oncologists. A very significant estimated correlation between CASCO and MCASCO was found that suggests that MCASCO might constitute an easy and valid tool for the staging of the cachectic cancer patients. CASCO and MCASCO provide a new tool for the quantitative staging of cachectic cancer patients with a clear advantage over previous classifications.

Validation of a new mortality risk prediction model for people 65 years and older in northwest Russia: The Crystal risk score.

PubMed

Turusheva, Anna; Frolova, Elena; Bert, Vaes; Hegendoerfer, Eralda; Degryse, Jean-Marie

2017-07-01

Prediction models help to make decisions about further management in clinical practice. This study aims to develop a mortality risk score based on previously identified risk predictors and to perform internal and external validations. In a population-based prospective cohort study of 611 community-dwelling individuals aged 65+ in St. Petersburg (Russia), all-cause mortality risks over 2.5 years follow-up were determined based on the results obtained from anthropometry, medical history, physical performance tests, spirometry and laboratory tests. C-statistic, risk reclassification analysis, integrated discrimination improvement analysis, decision curves analysis, internal validation and external validation were performed. Older adults were at higher risk for mortality [HR (95%CI)=4.54 (3.73-5.52)] when two or more of the following components were present: poor physical performance, low muscle mass, poor lung function, and anemia. If anemia was combined with high C-reactive protein (CRP) and high B-type natriuretic peptide (BNP) was added the HR (95%CI) was slightly higher (5.81 (4.73-7.14)) even after adjusting for age, sex and comorbidities. Our models were validated in an external population of adults 80+. The extended model had a better predictive capacity for cardiovascular mortality [HR (95%CI)=5.05 (2.23-11.44)] compared to the baseline model [HR (95%CI)=2.17 (1.18-4.00)] in the external population. We developed and validated a new risk prediction score that may be used to identify older adults at higher risk for mortality in Russia. Additional studies need to determine which targeted interventions improve the outcomes of these at-risk individuals. Copyright © 2017 Elsevier B.V. All rights reserved.

Development and validation of the Surgical Outcome Risk Tool (SORT)

PubMed Central

Protopapa, K L; Simpson, J C; Smith, N C E; Moonesinghe, S R

2014-01-01

Background Existing risk stratification tools have limitations and clinical experience suggests they are not used routinely. The aim of this study was to develop and validate a preoperative risk stratification tool to predict 30-day mortality after non-cardiac surgery in adults by analysis of data from the observational National Confidential Enquiry into Patient Outcome and Death (NCEPOD) Knowing the Risk study. Methods The data set was split into derivation and validation cohorts. Logistic regression was used to construct a model in the derivation cohort to create the Surgical Outcome Risk Tool (SORT), which was tested in the validation cohort. Results Prospective data for 19 097 cases in 326 hospitals were obtained from the NCEPOD study. Following exclusion of 2309, details of 16 788 patients were analysed (derivation cohort 11 219, validation cohort 5569). A model of 45 risk factors was refined on repeated regression analyses to develop a model comprising six variables: American Society of Anesthesiologists Physical Status (ASA-PS) grade, urgency of surgery (expedited, urgent, immediate), high-risk surgical specialty (gastrointestinal, thoracic, vascular), surgical severity (from minor to complex major), cancer and age 65 years or over. In the validation cohort, the SORT was well calibrated and demonstrated better discrimination than the ASA-PS and Surgical Risk Scale; areas under the receiver operating characteristic (ROC) curve were 0·91 (95 per cent c.i. 0·88 to 0·94), 0·87 (0·84 to 0·91) and 0·88 (0·84 to 0·92) respectively (P < 0·001). Conclusion The SORT allows rapid and simple data entry of six preoperative variables, and provides a percentage mortality risk for individuals undergoing surgery. PMID:25388883

West German Study Group Phase III PlanB Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment.

PubMed

Gluz, Oleg; Nitz, Ulrike A; Christgen, Matthias; Kates, Ronald E; Shak, Steven; Clemens, Michael; Kraemer, Stefan; Aktas, Bahriye; Kuemmel, Sherko; Reimer, Toralf; Kusche, Manfred; Heyl, Volker; Lorenz-Salehi, Fatemeh; Just, Marianne; Hofmann, Daniel; Degenhardt, Tom; Liedtke, Cornelia; Svedman, Christer; Wuerstlein, Rachel; Kreipe, Hans H; Harbeck, Nadia

2016-07-10

The 21-gene Recurrence Score (RS) assay is a validated prognostic/predictive tool in early hormone receptor-positive breast cancer (BC); however, only a few prospective outcome results have been available so far. In the phase III PlanB trial, RS was prospectively used to define a subset of patients who received only endocrine therapy. We present 3-year outcome data and concordance analysis (among biomarkers/RS). Central tumor bank was established prospectively from PlanB (intermediate and high-risk, locally human epidermal growth factor receptor 2-negative BC). After an early amendment, HR-positive, pN0-1 patients with RS ≤ 11 were recommended to omit chemotherapy. From 2009 to 2011, PlanB enrolled 3,198 patients with a median age of 56 years; 41.1% had node-positive and 32.5% grade 3 disease. In 348 patients (15.3%), chemotherapy was omitted based on RS ≤ 11. After 35 months median follow-up, 3-year disease-free survival in patients with RS ≤ 11 and endocrine therapy alone was 98% versus 92% and 98% in RS > 25 and RS 12 to 25 in chemotherapy-treated patients, respectively. Nodal status, central and local grade, the Ki-67 protein encoded by the MKI67 gene, estrogen receptor, progesterone receptor, tumor size, and RS were univariate prognostic factors for disease-free survival; only nodal status, both central and local grade, and RS were independent multivariate factors. Histologic grade was discordant between central and local laboratories in 44%. RS was positively but moderately correlated with the Ki-67 protein encoded by the MKI67 gene and grade and negatively correlated with progesterone receptor and estrogen receptor. In this prospective trial, patients with enhanced clinical risk and omitted chemotherapy on the basis of RS ≤ 11 had excellent 3-year survival. The substantial discordance observed between traditional prognostic markers and RS emphasizes the need for standardized assessment and supports the potential integration of standardized, well-validated genomic assays such as RS with clinicopathologic prognostic factors for chemotherapy indication in early hormone receptor-positive BC. © 2016 by American Society of Clinical Oncology.

Ambulance Clinical Triage for Acute Stroke Treatment: Paramedic Triage Algorithm for Large Vessel Occlusion.

PubMed

Zhao, Henry; Pesavento, Lauren; Coote, Skye; Rodrigues, Edrich; Salvaris, Patrick; Smith, Karen; Bernard, Stephen; Stephenson, Michael; Churilov, Leonid; Yassi, Nawaf; Davis, Stephen M; Campbell, Bruce C V

2018-04-01

Clinical triage scales for prehospital recognition of large vessel occlusion (LVO) are limited by low specificity when applied by paramedics. We created the 3-step ambulance clinical triage for acute stroke treatment (ACT-FAST) as the first algorithmic LVO identification tool, designed to improve specificity by recognizing only severe clinical syndromes and optimizing paramedic usability and reliability. The ACT-FAST algorithm consists of (1) unilateral arm drift to stretcher <10 seconds, (2) severe language deficit (if right arm is weak) or gaze deviation/hemineglect assessed by simple shoulder tap test (if left arm is weak), and (3) eligibility and stroke mimic screen. ACT-FAST examination steps were retrospectively validated, and then prospectively validated by paramedics transporting culturally and linguistically diverse patients with suspected stroke in the emergency department, for the identification of internal carotid or proximal middle cerebral artery occlusion. The diagnostic performance of the full ACT-FAST algorithm was then validated for patients accepted for thrombectomy. In retrospective (n=565) and prospective paramedic (n=104) validation, ACT-FAST displayed higher overall accuracy and specificity, when compared with existing LVO triage scales. Agreement of ACT-FAST between paramedics and doctors was excellent (κ=0.91; 95% confidence interval, 0.79-1.0). The full ACT-FAST algorithm (n=60) assessed by paramedics showed high overall accuracy (91.7%), sensitivity (85.7%), specificity (93.5%), and positive predictive value (80%) for recognition of endovascular-eligible LVO. The 3-step ACT-FAST algorithm shows higher specificity and reliability than existing scales for clinical LVO recognition, despite requiring just 2 examination steps. The inclusion of an eligibility step allowed recognition of endovascular-eligible patients with high accuracy. Using a sequential algorithmic approach eliminates scoring confusion and reduces assessment time. Future studies will test whether field application of ACT-FAST by paramedics to bypass suspected patients with LVO directly to endovascular-capable centers can reduce delays to endovascular thrombectomy. © 2018 American Heart Association, Inc.

A prediction tool for nosocomial multi-drug Resistant Gram-Negative Bacilli infections in critically ill patients - prospective observational study.

PubMed

Vasudevan, Anupama; Mukhopadhyay, Amartya; Li, Jialiang; Yuen, Eugene Goh Yu; Tambyah, Paul Ananth

2014-11-25

The widespread use of empiric broad spectrum antibiotics has contributed to the global increase of Resistant Gram-Negative Bacilli (RGNB) infections in intensive care units (ICU). The aim of this study was to develop a tool to predict nosocomial RGNB infections among ICU patients for targeted therapy. We conducted a prospective observational study from August'07 to December'11. All adult patients who were admitted and stayed for more than 24 hours at the medical and surgical ICU's were included. All patients who developed nosocomial RGNB infections 48 hours after ICU admission were identified. A prediction score was formulated by using independent risk factors obtained from logistic regression analysis. This was prospectively validated with a subsequent cohort of patients admitted to the ICUs during the following time period of January-September 2012. Seventy-six patients with nosocomial RGNB Infection (31bacteremia) were compared with 1398 patients with Systemic Inflammatory Response Syndrome (SIRS) without any gram negative bacterial infection/colonization admitted to the ICUs during the study period. The following independent risk factors were obtained by a multivariable logistic regression analysis - prior isolation of Gram negative organism (coeff: 1.1, 95% CI 0.5-1.7); Surgery during current admission (coeff: 0.69, 95% CI 0.2-1.2); prior Dialysis with end stage renal disease (coeff: 0.7, 95% CI 0.1-1.1); prior use of Carbapenems (coeff: 1.3, 95% CI 0.3-2.3) and Stay in the ICU for more than 5 days (coeff: 2.4, 95% CI 1.6-3.2). It was validated prospectively in a subsequent cohort (n = 408) and the area-under-the-curve (AUC) of the GSDCS score for predicting nosocomial ICU acquired RGNB infection and bacteremia was 0.77 (95% CI 0.68-0.89 and 0.78 (95% CI 0.69-0.89) respectively. The GSDCS (0-4.3) score clearly differentiated the low (0-1.3), medium (1.4-2.3) and high (2.4-4.3) risk patients, both for RGNB infection (p:0.003) and bacteremia (p:0.009). GSDCS is a simple bedside clinical score which predicts RGNB infection and bacteremia with high predictive value and differentiates low versus high risk patients. This score will help clinicians to choose appropriate, timely targeted antibiotic therapy and avoid exposure to unnecessary treatment for patients at low risk of nosocomial RGNB infection. This will reduce the selection pressure and help to contain antibiotic resistance in ICUs.

Using cluster analysis to identify phenotypes and validation of mortality in men with COPD.

PubMed

Chen, Chiung-Zuei; Wang, Liang-Yi; Ou, Chih-Ying; Lee, Cheng-Hung; Lin, Chien-Chung; Hsiue, Tzuen-Ren

2014-12-01

Cluster analysis has been proposed to examine phenotypic heterogeneity in chronic obstructive pulmonary disease (COPD). The aim of this study was to use cluster analysis to define COPD phenotypes and validate them by assessing their relationship with mortality. Male subjects with COPD were recruited to identify and validate COPD phenotypes. Seven variables were assessed for their relevance to COPD, age, FEV(1) % predicted, BMI, history of severe exacerbations, mMRC, SpO(2), and Charlson index. COPD groups were identified by cluster analysis and validated prospectively against mortality during a 4-year follow-up. Analysis of 332 COPD subjects identified five clusters from cluster A to cluster E. Assessment of the predictive validity of these clusters of COPD showed that cluster E patients had higher all cause mortality (HR 18.3, p < 0.0001), and respiratory cause mortality (HR 21.5, p < 0.0001) than those in the other four groups. Cluster E patients also had higher all cause mortality (HR 14.3, p = 0.0002) and respiratory cause mortality (HR 10.1, p = 0.0013) than patients in cluster D alone. COPD patient with severe airflow limitation, many symptoms, and a history of frequent severe exacerbations was a novel and distinct clinical phenotype predicting mortality in men with COPD.

Validation of Computerized Automatic Calculation of the Sequential Organ Failure Assessment Score

PubMed Central

Harrison, Andrew M.; Pickering, Brian W.; Herasevich, Vitaly

2013-01-01

Purpose. To validate the use of a computer program for the automatic calculation of the sequential organ failure assessment (SOFA) score, as compared to the gold standard of manual chart review. Materials and Methods. Adult admissions (age > 18 years) to the medical ICU with a length of stay greater than 24 hours were studied in the setting of an academic tertiary referral center. A retrospective cross-sectional analysis was performed using a derivation cohort to compare automatic calculation of the SOFA score to the gold standard of manual chart review. After critical appraisal of sources of disagreement, another analysis was performed using an independent validation cohort. Then, a prospective observational analysis was performed using an implementation of this computer program in AWARE Dashboard, which is an existing real-time patient EMR system for use in the ICU. Results. Good agreement between the manual and automatic SOFA calculations was observed for both the derivation (N=94) and validation (N=268) cohorts: 0.02 ± 2.33 and 0.29 ± 1.75 points, respectively. These results were validated in AWARE (N=60). Conclusion. This EMR-based automatic tool accurately calculates SOFA scores and can facilitate ICU decisions without the need for manual data collection. This tool can also be employed in a real-time electronic environment. PMID:23936639

Translation, cross-cultural adaptation and validation of SinoNasal Outcome Test (SNOT): 22 to Brazilian Portuguese.

PubMed

Kosugi, Eduardo Macoto; Chen, Vitor Guo; Fonseca, Viviane Maria Guerreiro da; Cursino, Milena Martins Pellogia; Mendes Neto, José Arruda; Gregório, Luís Carlos

2011-01-01

Quality of life questionnaires have been increasingly used in clinical trials to help establish the impact of medical intervention or to assess the outcome of health care services. Among disease-specific outcome measures, SNOT-22 was considered the most suitable tool for assessing chronic rhinosinusitis and patients with nasal polyps. To perform translation, cross-cultural adaptation and validation of the SNOT-22 to Brazilian Portuguese. Prospective study involving eighty-nine patients with chronic rhinosinusitis or nasal polyps submitted to functional endoscopic sinus surgery, who answered the questionnaire before and after surgery. Furthermore, 113 volunteers without sinonasal disease also answered the questionnaire. Internal consistency, test-retest reliability, measure validity, responsiveness and clinical interpretability were assessed. Mean preoperative, postoperative and no sinonasal disease scores were 62.39, 23.09 and 11.42, respectively (p<0.0001); showing validity and responsiveness. Internal consistency was high (Cronbach's alpha = 0.9276). Reliability was sufficiently good, considering inter-interviewers (r=0.81) and intra-interviewers within a 10 to 14 day-interval (r=0.72). Surgery effect size was 1.55. Minimally important difference was 14 points; and scores up to 10 points were considered normal. The Brazilian Portuguese SNOT-22 version is a valid instrument to assess patients with chronic rhinosinusitis and nasal polyps.

Nomogram-based prediction of survival in patients with advanced oesophagogastric adenocarcinoma receiving first-line chemotherapy: a multicenter prospective study in the era of trastuzumab

PubMed Central

Custodio, A; Carmona-Bayonas, A; Jiménez-Fonseca, P; Sánchez, M L; Viudez, A; Hernández, R; Cano, J M; Echavarria, I; Pericay, C; Mangas, M; Visa, L; Buxo, E; García, T; Rodríguez Palomo, A; Álvarez Manceñido, F; Lacalle, A; Macias, I; Azkarate, A; Ramchandani, A; Fernández Montes, A; López, C; Longo, F; Sánchez Bayona, R; Limón, M L; Díaz-Serrano, A; Hurtado, A; Madero, R; Gómez, C; Gallego, J

2017-01-01

Background: To develop and validate a nomogram and web-based calculator to predict overall survival (OS) in Caucasian-advanced oesophagogastric adenocarcinoma (AOA) patients undergoing first-line combination chemotherapy. Methods: Nine hundred twenty-four AOA patients treated at 28 Spanish teaching hospitals from January 2008 to September 2014 were used as derivation cohort. The result of an adjusted-Cox proportional hazards regression was represented as a nomogram and web-based calculator. The model was validated in 502 prospectively recruited patients treated between October 2014 and December 2016. Harrell's c-index was used to evaluate discrimination. Results: The nomogram includes seven predictors associated with OS: HER2-positive tumours treated with trastuzumab, Eastern Cooperative Oncology Group performance status, number of metastatic sites, bone metastases, ascites, histological grade, and neutrophil-to-lymphocyte ratio. Median OS was 5.8 (95% confidence interval (CI), 4.5–6.6), 9.4 (95% CI, 8.5–10.6), and 14 months (95% CI, 11.8–16) for high-, intermediate-, and low-risk groups, respectively (P<0.001), in the derivation set and 4.6 (95% CI, 3.3–8.1), 12.7 (95% CI, 11.3–14.3), and 18.3 months (95% CI, 14.6–24.2) for high-, intermediate-, and low-risk groups, respectively (P<0.001), in the validation set. The nomogram is well-calibrated and reveals acceptable discriminatory capacity, with optimism-corrected c-indices of 0.618 (95% CI, 0.591–0.631) and 0.673 (95% CI, 0.636–0.709) in derivation and validation groups, respectively. The AGAMENON nomogram outperformed the Royal Marsden Hospital (c-index=0.583; P=0.00046) and Japan Clinical Oncology Group prognostic indices (c-index=0.611; P=0.03351). Conclusions: We developed and validated a straightforward model to predict survival in Caucasian AOA patients initiating first-line polychemotherapy. This model can contribute to inform clinical decision-making and optimise clinical trial design. PMID:28463962

Reliability, validity, and sensitivity to change of the lower extremity functional scale in individuals affected by stroke.

PubMed

Verheijde, Joseph L; White, Fred; Tompkins, James; Dahl, Peder; Hentz, Joseph G; Lebec, Michael T; Cornwall, Mark

2013-12-01

To investigate reliability, validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke. The secondary objective was to test the validity and sensitivity of a single-item linear analog scale (LAS) of function. Prospective cohort reliability and validation study. A single rehabilitation department in an academic medical center. Forty-three individuals receiving neurorehabilitation for lower extremity dysfunction after stroke were studied. Their ages ranged from 32 to 95 years, with a mean of 70 years; 77% were men. Test-retest reliability was assessed by calculating the classical intraclass correlation coefficient, and the Bland-Altman limits of agreement. Validity was assessed by calculating the Pearson correlation coefficient between the instruments. Sensitivity to change was assessed by comparing baseline scores with end of treatment scores. Measurements were taken at baseline, after 1-3 days, and at 4 and 8 weeks. The LEFS, Short-Form-36 Physical Function Scale, Berg Balance Scale, Six-Minute Walk Test, Five-Meter Walk Test, Timed Up-and-Go test, and the LAS of function were used. The test-retest reliability of the LEFS was found to be excellent (ICC = 0.96). Correlated with the 6 other measures of function studied, the validity of the LEFS was found to be moderate to high (r = 0.40-0.71). Regarding the sensitivity to change, the mean LEFS scores from baseline to study end increased 1.2 SD and for LAS 1.1 SD. LEFS exhibits good reliability, validity, and sensitivity to change in patients with lower extremity impairments secondary to stroke. Therefore, the LEFS can be a clinically efficient outcome measure in the rehabilitation of patients with subacute stroke. The LAS is shown to be a time-saving and reasonable option to track changes in a patient's functional status. Copyright © 2013 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Prospective assessment of autism traits in children exposed to antiepileptic drugs during pregnancy.

PubMed

Wood, Amanda G; Nadebaum, Caroline; Anderson, Vicki; Reutens, David; Barton, Sarah; O'Brien, Terence J; Vajda, Frank

2015-07-01

The association between autism spectrum disorders (ASDs) and prenatal anticonvulsant exposure is increasingly investigated, but comprehensive, blinded assessment using a validated instrument for autism within a well-characterized prospective cohort has not been conducted. Thus, existing studies may represent an underestimate of the true risk. Herein we present a prospective cohort study in children exposed to anticonvulsants during pregnancy, with all assessments conducted by examiners who were blinded to drug-exposure status. Participants were 105 Australian children aged 6-8 years who were recruited via the Australian Pregnancy Register for Women on Antiepileptic Medication. Maternal epilepsy, pregnancy, and medical history data were obtained prospectively. Autism traits were assessed using the Childhood Autism Rating Scale (CARS). Eleven children (10.5%) had elevated CARS scores. Two were exposed to valproate monotherapy (2/26; 7.7%), two to carbamazepine monotherapy (2/34; 5.9%), and seven to valproate in polytherapy (7/15; 46.7%). Linear regression analysis showed that the mean valproate dose during pregnancy was a significant predictor of CARS scores after controlling for polytherapy, mean carbamazepine dose, folic acid use, seizures during pregnancy, tobacco and marijuana use, maternal intelligence quotient (IQ), and socioeconomic status. First trimester folic acid supplementation and marijuana use were also significant predictors of CARS scores. Using direct assessment of children in our prospective study, we found an elevated rate of autism traits across the sample. The most important determinant of association with autistic traits was higher doses of sodium valproate exposure. The use of valproate in women who may become pregnant is now generally avoided; however, there are insufficient data regarding the risk of ASD with low-dose valproate. If this risk is no greater than with other antiepileptic drugs (AED)s, it may enable women with genetic generalized epilepsy to retain optimal seizure control as well as minimize harm to their unborn child. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Is the Scale for Measuring Motivational Interviewing Skills a valid and reliable instrument for measuring the primary care professionals motivational skills?: EVEM study protocol.

PubMed

Pérula, Luis Á; Campiñez, Manuel; Bosch, Josep M; Barragán Brun, Nieves; Arboniés, Juan C; Bóveda Fontán, Julia; Martín Alvarez, Remedios; Prados, Jose A; Martín-Rioboó, Enrique; Massons, Josep; Criado, Margarita; Fernández, José Á; Parras, Juan M; Ruiz-Moral, Roger; Novo, Jesús M

2012-11-22

Lifestyle is one of the main determinants of people's health. It is essential to find the most effective prevention strategies to be used to encourage behavioral changes in their patients. Many theories are available that explain change or adherence to specific health behaviors in subjects. In this sense the named Motivational Interviewing has increasingly gained relevance. Few well-validated instruments are available for measuring doctors' communication skills, and more specifically the Motivational Interviewing. The hypothesis of this study is that the Scale for Measuring Motivational Interviewing Skills (EVEM questionnaire) is a valid and reliable instrument for measuring the primary care professionals skills to get behavior change in patients. To test the hypothesis we have designed a prospective, observational, multi-center study to validate a measuring instrument. - Thirty-two primary care centers in Spain. -Sampling and Size: a) face and consensual validity: A group composed of 15 experts in Motivational Interviewing. b) Assessment of the psychometric properties of the scale; 50 physician- patient encounters will be videoed; a total of 162 interviews will be conducted with six standardized patients, and another 200 interviews will be conducted with 50 real patients (n=362). Four physicians will be specially trained to assess 30 interviews randomly selected to test the scale reproducibility. -Measurements for to test the hypothesis: a) Face validity: development of a draft questionnaire based on a theoretical model, by using Delphi-type methodology with experts. b) Scale psychometric properties: intraobservers will evaluate video recorded interviews: content-scalability validity (Exploratory Factor Analysis), internal consistency (Cronbach alpha), intra-/inter-observer reliability (Kappa index, intraclass correlation coefficient, Bland & Altman methodology), generalizability, construct validity and sensitivity to change (Pearson product-moment correlation coefficient). The verification of the hypothesis that EVEM is a valid and reliable tool for assessing motivational interviewing would be a major breakthrough in the current theoretical and practical knowledge, as it could be used to assess if the providers put into practice a patient centered communication style and can be used both for training or researching purposes. TRIALS REGISTRATION Dislip-EM study: NCT01282190 (ClinicalTrials.gov).

[Design and validation of a questionnaire to assess the level of general knowledge on eating disorders in students of Health Sciences].

PubMed

Sánchez Socarrás, Violeida; Aguilar Martínez, Alicia; Vaqué Crusellas, Cristina; Milá Villarroel, Raimon; González Rivas, Fabián

2016-01-01

To design and validate a questionnaire to assess the level of knowledge regarding eating disorders in college students. Observational, prospective, and longitudinal study, with the design of the questionnaire based on a conceptual review and validation by a cognitive pre-test and pilot test-retest, with analysis of the psychometric properties in each application. University Foundation of Bages, Barcelona. Marco community care. A total of 140 students from Health Sciences; 53 women and 87 men with a mean age of 21.87 years; 28 participated in the pre-test and 112 in the test-retests, 110 students completed the study. Validity and stability study using Cronbach α and Pearson product-moment correlation coefficient statistics; relationship skills with sex and type of study, non-parametric statistical Mann-Whitney and Kruskal-Wallis tests; for demographic variables, absolute or percentage frequencies, as well as mean, central tendency and standard deviation as measures of dispersion were calculated. The statistical significance level was 95% confidence. The questionnaire was obtained that had 10 questions divided into four dimensions (classification, demographics characteristics of patients, risk factors and clinical manifestations of eating disorders). The scale showed good internal consistency in its final version (Cronbach α=0.724) and adequate stability (Pearson correlation 0.749). The designed tool can be accurately used to assess Health Sciences students' knowledge of eating disorders. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

The validation of the visual analogue scale for patient satisfaction after total hip arthroplasty.

PubMed

Brokelman, Roy B G; Haverkamp, Daniel; van Loon, Corné; Hol, Annemiek; van Kampen, Albert; Veth, Rene

2012-06-01

INTRODUCTION: Patient satisfaction becomes more important in our modern health care system. The assessment of satisfaction is difficult because it is a multifactorial item for which no golden standard exists. One of the potential methods of measuring satisfaction is by using the well-known visual analogue scale (VAS). In this study, we validated VAS for satisfaction. PATIENT AND METHODS: In this prospective study, we studied 147 patients (153 hips). The construct validity was measured using the Spearman correlation test that compares the satisfaction VAS with the Harris hip score, pain VAS at rest and during activity, Oxford hip score, Short Form 36 and Western Ontario McMaster Universities Osteoarthritis Index. The reliability was tested using the intra-class coefficient. RESULTS: The Pearson correlation test showed correlations in the range of 0.40-0.80. The satisfaction VAS had a high correlation between the pain VAS and Oxford hip score, which could mean that pain is one of the most important factors in patient satisfaction. The intra-class coefficient was 0.95. CONCLUSIONS: There is a moderate to mark degree of correlation between the satisfaction VAS and the currently available subjective and objective scoring systems. The intra-class coefficient of 0.95 indicates an excellent test-retest reliability. The VAS satisfaction is a simple instrument to quantify the satisfaction of a patient after total hip arthroplasty. In this study, we showed that the satisfaction VAS has a good validity and reliability.

Seizures in the elderly: development and validation of a diagnostic algorithm.

PubMed

Dupont, Sophie; Verny, Marc; Harston, Sandrine; Cartz-Piver, Leslie; Schück, Stéphane; Martin, Jennifer; Puisieux, François; Alecu, Cosmin; Vespignani, Hervé; Marchal, Cécile; Derambure, Philippe

2010-05-01

Seizures are frequent in the elderly, but their diagnosis can be challenging. The objective of this work was to develop and validate an expert-based algorithm for the diagnosis of seizures in elderly people. A multidisciplinary group of neurologists and geriatricians developed a diagnostic algorithm using a combination of selected clinical, electroencephalographical and radiological criteria. The algorithm was validated by multicentre retrospective analysis of data of patients referred for specific symptoms and classified by the experts as epileptic patients or not. The algorithm was applied to all the patients, and the diagnosis provided by the algorithm was compared to the clinical diagnosis of the experts. Twenty-nine clinical, electroencephalographical and radiological criteria were selected for the algorithm. According to criteria combination, seizures were classified in four levels of diagnosis: certain, highly probable, possible or improbable. To validate the algorithm, the medical records of 269 elderly patients were analyzed (138 with epileptic seizures, 131 with non-epileptic manifestations). Patients were mainly referred for a transient focal deficit (40%), confusion (38%), unconsciousness (27%). The algorithm best classified certain and probable seizures versus possible and improbable seizures, with 86.2% sensitivity and 67.2% specificity. Using logistical regression, 2 simplified models were developed, the first with 13 criteria (Se 85.5%, Sp 90.1%), and the second with 7 criteria only (Se 84.8%, Sp 88.6%). In conclusion, the present study validated the use of a revised diagnostic algorithm to help diagnosis epileptic seizures in the elderly. A prospective study is planned to further validate this algorithm. Copyright 2010 Elsevier B.V. All rights reserved.

Making and Executing Decisions for Safe and Independent Living (MED-SAIL): Development and Validation of a Brief Screening Tool

PubMed Central

Mills, Whitney L.; Regev, Tziona; Kunik, Mark E.; Wilson, Nancy L.; Moye, Jennifer; McCullough, Laurence B.; Naik, Aanand D.

2017-01-01

Objectives Older adults prefer to remain in their own homes for as long as possible. The purpose of this article is to describe the development and preliminary validation of Making and Executing Decisions for Safe and Independent Living (MED-SAIL), a brief screening tool for capacity to live safely and independently in the community. Design Prospective preliminary validation study. Setting Outpatient geriatrics clinic located in a community-based hospital. Participants Forty-nine community-dwelling older adults referred to the clinic for a comprehensive capacity assessment. Measurements We examined internal consistency, criterion-based validity, concurrent validity, and accuracy of classification for MED-SAIL. Results The items included in MED-SAIL demonstrated internal consistency (5 items; α = 0.85). MED-SAIL was significantly correlated with the Independent Living Scales (r = 0.573, p ≤ 0.001) and instrumental activities of daily living (r = 0.440, p ≤ 0.01). The Mann-Whitney U test revealed significant differences between the no capacity and partial/full capacity classifications on MED-SAIL (U(48) = 60.5, Z = −0.38, p <0.0001). The area under the curve was 0.864 (95% confidence interval: 0.84–0.99). Conclusions This study demonstrated the validity of MED-SAIL as a brief screening tool to identify older adults with impaired capacity for remaining safe and independent in their current living environment. MED-SAIL is useful tool for health and social service providers in the community for the purpose of referral for definitive capacity evaluation. PMID:23567420

Motor performance and physical activity as predictors of prospective falls in community-dwelling, older adults by frailty level: Application of wearable technology

PubMed Central

Mohler, M. Jane; Wendel, Christopher S.; Taylor-Piliae, Ruth E.; Toosizadeh, Nima; Najafi, Bijan

2016-01-01

Background Few studies of the association between prospective falls and sensor-based measures of motor performance and physical activity have evaluated subgroups of frailty status separately. Objective To evaluate wearable sensor-based measures of gait, balance, and physical activity (PA) that are predictive of future falls in community-dwelling older adults. Methods The Arizona Frailty Cohort Study in Tucson, Arizona followed community-dwelling adults aged 65 years and over (without baseline cognitive deficit, severe movement disorders, or recent stroke) for falls over six months. Baseline measures included Fried frailty criteria; in-home, and sensor-based gait (normal and fast walk), balance (bipedal eyes open and eyes closed), and spontaneous daily PA over 48 hours, measured using validated wearable technologies. Results Of the 119 participants (36% non-frail, 48% pre-frail, and 16% frail), 48 reported one or more fall (47% of non-frail, 33% of pre-frail, and 47% of frail). Although balance deficit and PA were independent fall predictors in pre-frail and frail groups, they were not sensitive to predict prospective falls in the non-frail group. Even though gait performance deteriorated as frailty increased, gait was not a predictor of prospective falls when participants were stratified based on frailty status. In pre-frail and frail participants combined, center of mass sway (OR= 5.9, 95% CI 2.6 – 13.7), PA mean walking bout duration (OR = 1.1, 95% CI 1.0 – 1.2), PA mean standing bout duration (OR = .94, 95% CI .91 - .99), and a fall in previous 6 months (OR = 7.3, 95% CI 1.5 – 36.4) were independent predictors for prospective falls (AUC: 0.882). Conclusion This study suggests that independent predictors of falls are dependent on frailty status. Among sensor-derived parameters, balance deficit, longer typical walking episodes, and shorter typical standing episodes were the most sensitive predictors of prospective falls in the combined pre-frail and frail sample. Gait deficit was not a sensitive fall predictor in the context of frailty status. PMID:27160666

Assessment in Science Education

NASA Astrophysics Data System (ADS)

Rustaman, N. Y.

2017-09-01

An analyses study focusing on scientific reasoning literacy was conducted to strengthen the stressing on assessment in science by combining the important of the nature of science and assessment as references, higher order thinking and scientific skills in assessing science learning as well. Having background in developing science process skills test items, inquiry in its many form, scientific and STEM literacy, it is believed that inquiry based learning should first be implemented among science educators and science learners before STEM education can successfully be developed among science teachers, prospective teachers, and students at all levels. After studying thoroughly a number of science researchers through their works, a model of scientific reasoning was proposed, and also simple rubrics and some examples of the test items were introduced in this article. As it is only the beginning, further studies will still be needed in the future with the involvement of prospective science teachers who have interests in assessment, either on authentic assessment or in test items development. In balance usage of alternative assessment rubrics, as well as valid and reliable test items (standard) will be needed in accelerating STEM education in Indonesia.

TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial.

PubMed

Krofta, Ladislav; Feyereisl, Jaroslav; Otcenásek, Michal; Velebil, Petr; Kasíková, Eva; Krcmár, Michal

2010-02-01

A study was conducted to compare the efficacy and complications of TVT and TVT-O. This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated with TVT-O. At the 1 year follow-up, 141 TVT patients and 147 TVT-O patients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. The mean operating time was shorter in the TVT-O group (p < 0.001). Urinary retention was not significantly different (p > 0.05). Inner thigh discomfort was reported by 5.4% of TVT-O patients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-O patients (p = 0.015). The groups showed comparable objective and subjective cure rates.

The effect of visiting surgical patients in the postanesthesia care unit on family members' anxiety: a prospective quasi-experimental study.

PubMed

Patelarou, Athina; Melidoniotis, Evangelos; Sgouraki, Maria; Karatzi, Maria; Souvatzis, Xenia

2014-06-01

Surgical procedures pose stressful events for patients and their family members. The main purpose of this study was to determine if visiting patients in the postanesthesia care unit (PACU) would reduce the anxiety levels of Greek patients' family members. A prospective study with a one-group quasi-experimental pretest/post-test design was used. Situational anxiety of surgical patients' relatives was assessed using the state subscale of the State-Trait Anxiety Inventory (STAI; Greek validation) at the beginning of the surgical procedure and again after their visitation of patients in the PACU. STAI scores were significantly higher preoperatively (57 [23-80]) than postoperatively (51 [21-77]; P=.000008). Clinically significant levels of anxiety were present in 76% and 58% of the participants, pre- and postoperatively, respectively. Although postoperative STAI scores were reduced, family visitation in the PACU did not sufficiently reduce the anxiety of Greek family members to clinically acceptable levels. Copyright © 2014 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Prospective study of the evolution of blood lymphoid immune parameters during dacarbazine chemotherapy in metastatic and locally advanced melanoma patients.

PubMed

Mignot, Grégoire; Hervieu, Alice; Vabres, Pierre; Dalac, Sophie; Jeudy, Geraldine; Bel, Blandine; Apetoh, Lionel; Ghiringhelli, François

2014-01-01

The importance of immune responses in the control of melanoma growth is well known. However, the implication of these antitumor immune responses in the efficacy of dacarbazine, a cytotoxic drug classically used in the treatment of melanoma, remains poorly understood in humans. In this prospective observational study, we performed an immunomonitoring of eleven metastatic or locally advanced patients treated with dacarbazine as a first line of treatment. We assessed by flow cytometry lymphoid populations and their activation state; we also isolated NK cells to perform in vitro cytotoxicity tests. We found that chemotherapy induces lymphopenia and that a significantly higher numbers of naïve CD4+ T cells and lower proportion of Treg before chemotherapy are associated with disease control after dacarbazine treatment. Interestingly, NK cell cytotoxicity against dacarbazine-pretreated melanoma cells is only observed in NK cells from patients who achieved disease control. Together, our data pinpoint that some immune factors could help to predict the response of melanoma patients to dacarbazine. Future larger scale studies are warranted to test their validity as prediction markers.

An update on pharmacogenomics in rheumatoid arthritis with a focus on TNF-blocking agents.

PubMed

Ranganathan, Prabha

2008-12-01

TNFalpha is a proinflammatory cytokine, which is crucial in the pathogenesis of rheumatoid arthritis (RA). In recent years, biological therapies which block the damaging effects of TNFalpha on synovium and cartilage have been developed. TNF antagonists, such as etanercept, infliximab and adalimumab, although highly effective in RA, are expensive, totaling several thousand US dollars in yearly costs. In addition, only approximately 60% of patients respond to these agents. This has led to the need to prospectively identify patients most likely to respond to these agents, which can be achieved by pharmacogenomics approaches. Polymorphisms in genes encoding for TNFalpha, the MHC region, and the Fcgamma receptor IIIA, as well as their ability to predict disease progression in RA and response to anti-TNF therapies, have been the focus of a number of studies, which are discussed in this review. There is no consensus at present as to whether pharmacogenomics will allow prediction of anti-TNF therapy efficacy in RA. Large, prospective, multicenter studies are needed to replicate and validate the results of the studies outlined in this review.

The validation of a computer-adaptive test (CAT) for assessing health-related quality of life in children and adolescents in a clinical sample: study design, methods and first results of the Kids-CAT study.

PubMed

Barthel, D; Otto, C; Nolte, S; Meyrose, A-K; Fischer, F; Devine, J; Walter, O; Mierke, A; Fischer, K I; Thyen, U; Klein, M; Ankermann, T; Rose, M; Ravens-Sieberer, U

2017-05-01

Recently, we developed a computer-adaptive test (CAT) for assessing health-related quality of life (HRQoL) in children and adolescents: the Kids-CAT. It measures five generic HRQoL dimensions. The aims of this article were (1) to present the study design and (2) to investigate its psychometric properties in a clinical setting. The Kids-CAT study is a longitudinal prospective study with eight measurements over one year at two University Medical Centers in Germany. For validating the Kids-CAT, 270 consecutive 7- to 17-year-old patients with asthma (n = 52), diabetes (n = 182) or juvenile arthritis (n = 36) answered well-established HRQoL instruments (Pediatric Quality of Life Inventory™ (PedsQL), KIDSCREEN-27) and scales measuring related constructs (e.g., social support, self-efficacy). Measurement precision, test-retest reliability, convergent and discriminant validity were investigated. The mean standard error of measurement ranged between .38 and .49 for the five dimensions, which equals a reliability between .86 and .76, respectively. The Kids-CAT measured most reliably in the lower HRQoL range. Convergent validity was supported by moderate to high correlations of the Kids-CAT dimensions with corresponding PedsQL dimensions ranging between .52 and .72. A lower correlation was found between the social dimensions of both instruments. Discriminant validity was confirmed by lower correlations with non-corresponding subscales of the PedsQL. The Kids-CAT measures pediatric HRQoL reliably, particularly in lower areas of HRQoL. Its test-retest reliability should be re-investigated in future studies. The validity of the instrument was demonstrated. Overall, results suggest that the Kids-CAT is a promising candidate for detecting psychosocial needs in chronically ill children.

DNA methylation array analysis identifies breast cancer associated RPTOR, MGRN1 and RAPSN hypomethylation in peripheral blood DNA.

PubMed

Tang, Qiuqiong; Holland-Letz, Tim; Slynko, Alla; Cuk, Katarina; Marme, Frederik; Schott, Sarah; Heil, Jörg; Qu, Bin; Golatta, Michael; Bewerunge-Hudler, Melanie; Sutter, Christian; Surowy, Harald; Wappenschmidt, Barbara; Schmutzler, Rita; Hoth, Markus; Bugert, Peter; Bartram, Claus R; Sohn, Christof; Schneeweiss, Andreas; Yang, Rongxi; Burwinkel, Barbara

2016-09-27

DNA methylation changes in peripheral blood DNA have been shown to be associated with solid tumors. We sought to identify methylation alterations in whole blood DNA that are associated with breast cancer (BC). Epigenome-wide DNA methylation profiling on blood DNA from BC cases and healthy controls was performed by applying Infinium HumanMethylation450K BeadChips. Promising CpG sites were selected and validated in three independent larger sample cohorts via MassARRAY EpiTyper assays. CpG sites located in three genes (cg06418238 in RPTOR, cg00736299 in MGRN1 and cg27466532 in RAPSN), which showed significant hypomethylation in BC patients compared to healthy controls in the discovery cohort (p < 1.00 x 10-6) were selected and successfully validated in three independent cohorts (validation I, n =211; validation II, n=378; validation III, n=520). The observed methylation differences are likely not cell-type specific, as the differences were only seen in whole blood, but not in specific sub cell-types of leucocytes. Moreover, we observed in quartile analysis that women in the lower methylation quartiles of these three loci had higher ORs than women in the higher quartiles. The combined AUC of three loci was 0.79 (95%CI 0.73-0.85) in validation cohort I, and was 0.60 (95%CI 0.54-0.66) and 0.62 (95%CI 0.57-0.67) in validation cohort II and III, respectively. Our study suggests that hypomethylation of CpG sites in RPTOR, MGRN1 and RAPSN in blood is associated with BC and might serve as blood-based marker supplements for BC if these could be verified in prospective studies.

PROMO – Real-time Prospective Motion Correction in MRI using Image-based Tracking

PubMed Central

White, Nathan; Roddey, Cooper; Shankaranarayanan, Ajit; Han, Eric; Rettmann, Dan; Santos, Juan; Kuperman, Josh; Dale, Anders

2010-01-01

Artifacts caused by patient motion during scanning remain a serious problem in most MRI applications. The prospective motion correction technique attempts to address this problem at its source by keeping the measurement coordinate system fixed with respect to the patient throughout the entire scan process. In this study, a new image-based approach for prospective motion correction is described, which utilizes three orthogonal 2D spiral navigator acquisitions (SP-Navs) along with a flexible image-based tracking method based on the Extended Kalman Filter (EKF) algorithm for online motion measurement. The SP-Nav/EKF framework offers the advantages of image-domain tracking within patient-specific regions-of-interest and reduced sensitivity to off-resonance-induced corruption of rigid-body motion estimates. The performance of the method was tested using offline computer simulations and online in vivo head motion experiments. In vivo validation results covering a broad range of staged head motions indicate a steady-state error of the SP-Nav/EKF motion estimates of less than 10 % of the motion magnitude, even for large compound motions that included rotations over 15 degrees. A preliminary in vivo application in 3D inversion recovery spoiled gradient echo (IR-SPGR) and 3D fast spin echo (FSE) sequences demonstrates the effectiveness of the SP-Nav/EKF framework for correcting 3D rigid-body head motion artifacts prospectively in high-resolution 3D MRI scans. PMID:20027635

CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: a prospective randomized controlled study.

PubMed

Caraco, Y; Blotnick, S; Muszkat, M

2008-03-01

Warfarin anticoagulation effect is characterized by marked variability, some of which has been attributed to CYP2C9 polymorphisms. This study prospectively examines whether a priori knowledge of CYP2C9 genotype may improve warfarin therapy. Patients were randomly assigned to receive warfarin by a validated algorithm ("control", 96 patients) or CYP2C9 genotype-adjusted algorithms ("study", 95 patients). The first therapeutic international normalized ratio and stable anticoagulation were reached 2.73 and 18.1 days earlier in the study group, respectively (P<0.001). The faster rate of initial anticoagulation was driven by a 28% higher daily dose in the study group (P<0.001). Study group patients spent more time within the therapeutic range (80.4 vs 63.4%, respectively, P<0.001) and experienced less minor bleeding (3.2 vs 12.5%, P<0.02, respectively). In conclusion, CYP2C9 genotype-guided warfarin therapy is more efficient and safer than the "average-dose" protocol. Future research should focus on construction of algorithms that incorporate other polymorphisms (VKORC1), host factors, and environmental influences.

Simple shoulder test and Oxford Shoulder Score: Persian translation and cross-cultural validation.

PubMed

Naghdi, Soofia; Nakhostin Ansari, Noureddin; Rustaie, Nilufar; Akbari, Mohammad; Ebadi, Safoora; Senobari, Maryam; Hasson, Scott

2015-12-01

To translate, culturally adapt, and validate the simple shoulder test (SST) and Oxford Shoulder Score (OSS) into Persian language using a cross-sectional and prospective cohort design. A standard forward and backward translation was followed to culturally adapt the SST and the OSS into Persian language. Psychometric properties of floor and ceiling effects, construct convergent validity, discriminant validity, internal consistency reliability, test-retest reliability, standard error of the measurement (SEM), smallest detectable change (SDC), and factor structure were determined. One hundred patients with shoulder disorders and 50 healthy subjects participated in the study. The PSST and the POSS showed no missing responses. No floor or ceiling effects were observed. Both the PSST and POSS detected differences between patients and healthy subjects supporting their discriminant validity. Construct convergent validity was confirmed by a very good correlation between the PSST and POSS (r = 0.68). There was high internal consistency for both the PSST (α = 0.73) and the POSS (α = 0.91 and 0.92). Test-retest reliability with 1-week interval was excellent (ICCagreement = 0.94 for PSST and 0.90 for POSS). Factor analyses demonstrated a three-factor solution for the PSST (49.7 % of variance) and a two-factor solution for the POSS (61.6 % of variance). The SEM/SDC was satisfactory for PSST (5.5/15.3) and POSS (6.8/18.8). The PSST and POSS are valid and reliable outcome measures for assessing functional limitations in Persian-speaking patients with shoulder disorders.

Prospective evaluation of a bivalirudin to warfarin transition nomogram.

PubMed

Hohlfelder, Benjamin; Sylvester, Katelyn W; Rimsans, Jessica; DeiCicchi, David; Connors, Jean M

2017-05-01

Bivalirudin may cause a falsely prolonged international normalized ratio (INR) that complicates the discontinuation of bivalirudin when used as a bridge to warfarin. To prospectively validate our novel bivalirudin to warfarin transition nomogram, adult patients who received bivalirudin as a bridge to warfarin between July 2015 and June 2016 were prospectively evaluated, utilizing our predictive nomogram. The major outcome of our analysis was the correlation between the predicted change in INR upon bivalirudin discontinuation based on the nomogram, and the actual change in INR upon bivalirudin discontinuation. The major outcome was analyzed using the Pearson's correlation test. A Pearson's correlation coefficient >0.6 was considered to be a strong correlation. Bivalirudin was used as a bridge to warfarin in 29 patients. The majority of patients (86%) included in the analysis had a ventricular assist device. The median initial bivalirudin rate was 0.07 mg/kg/h and the mean increase in INR when starting bivalirudin was 0.6. The mean final weight-based bivalirudin rate was 0.08 mg/kg/h and the mean change in INR after stopping bivalirudin was 0.7. The Pearson correlation coefficient between the predicted change in INR upon bivalirudin discontinuation and the actual change in INR upon bivalirudin discontinuation was 0.86 (p < 0.001). After bivalirudin discontinuation, 68% of patients had a therapeutic INR. The results of this prospective analysis successfully validated our novel bivalirudin to warfarin transition nomogram. There was a very strong correlation between the predicted change and actual change in INR upon bivalirudin discontinuation.

A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries (protocol): the Australasian Paediatric Head Injury Rules Study (APHIRST).

PubMed

Babl, Franz E; Lyttle, Mark D; Bressan, Silvia; Borland, Meredith; Phillips, Natalie; Kochar, Amit; Dalziel, Stuart R; Dalton, Sarah; Cheek, John A; Furyk, Jeremy; Gilhotra, Yuri; Neutze, Jocelyn; Ward, Brenton; Donath, Susan; Jachno, Kim; Crowe, Louise; Williams, Amanda; Oakley, Ed

2014-06-13

Head injuries in children are responsible for a large number of emergency department visits. Failure to identify a clinically significant intracranial injury in a timely fashion may result in long term neurodisability and death. Whilst cranial computed tomography (CT) provides rapid and definitive identification of intracranial injuries, it is resource intensive and associated with radiation induced cancer. Evidence based head injury clinical decision rules have been derived to aid physicians in identifying patients at risk of having a clinically significant intracranial injury. Three rules have been identified as being of high quality and accuracy: the Canadian Assessment of Tomography for Childhood Head Injury (CATCH) from Canada, the Children's Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) from the UK, and the prediction rule for the identification of children at very low risk of clinically important traumatic brain injury developed by the Pediatric Emergency Care Applied Research Network (PECARN) from the USA. This study aims to prospectively validate and compare the performance accuracy of these three clinical decision rules when applied outside the derivation setting. This study is a prospective observational study of children aged 0 to less than 18 years presenting to 10 emergency departments within the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network in Australia and New Zealand after head injuries of any severity. Predictor variables identified in CATCH, CHALICE and PECARN clinical decision rules will be collected. Patients will be managed as per the treating clinicians at the participating hospitals. All patients not undergoing cranial CT will receive a follow up call 14 to 90 days after the injury. Outcome data collected will include results of cranial CTs (if performed) and details of admission, intubation, neurosurgery and death. The performance accuracy of each of the rules will be assessed using rule specific outcomes and inclusion and exclusion criteria. This study will allow the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting. The study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)- ACTRN12614000463673 (registered 2 May 2014).

Brief Assessment of Motor Function: Content Validity and Reliability of the Upper Extremity Gross Motor Scale

PubMed Central

Cintas, Holly Lea; Parks, Rebecca; Don, Sarah; Gerber, Lynn

2011-01-01

Content validity and reliability of the Brief Assessment of Motor Function (BAMF) Upper Extremity Gross Motor Scale (UEGMS) were evaluated in this prospective, descriptive study. The UEGMS is one of five ordinal scales designed for quick documentation of gross, fine and oral motor skill levels. Designed to be independent of age and diagnosis, it is intended for use for infants through young adults. An expert panel of 17 physical therapists and 13 occupational therapists refined the content by responding to a standard questionnaire comprised of questions which asked whether each item should be included, is clearly worded, should be reordered higher or lower, is functionally relevant, and is easily discriminated. Ratings of content validity exceeded the criterion except for two items which may represent different perspectives of physical and occupational therapists. The UEGMS was modified using the quantitative and qualitative feedback from the questionnaires. For reliability, five raters scored videotaped motor performances of ten children. Coefficients for inter-rater (0.94) and intra-rater (0.95) reliability were high. The results provide evidence of content validity and reliability of the UEGMS for assessment of upper extremity gross motor skill. PMID:21599568

Prospective transfrontal sheep model of skull-base reconstruction using vascularized mucosa.

PubMed

Mueller, Sarina K; Scangas, George; Amiji, Mansor M; Bleier, Benjamin S

2018-05-01

No high-fidelity animal model exists to examine prospective wound healing following vascularized reconstruction of the skull base. Such a model would require the ability to study the prospective behavior of vascularized mucosal repairs of large dural and arachnoid defects within the intranasal environment. The objective of this study was to therefore develop and validate a novel, in vivo, transfrontal sheep model of cranial base repair using vascularized sinonasal mucosa. Twelve transfrontal craniotomy and 1.5-cm durotomy reconstructions were performed in 60-kg to 70-kg Dorset/Ovis Aries sheep using vascularized mucosa with or without an adjunctive Biodesign™ underlay graft (n = 6 per group). Histologic outcomes were graded (scale, 0 to 4) by a blinded veterinary histopathologist after 7, 14, and 28 days for a range of wound healing parameters. All sheep tolerated the surgery, which required 148 ± 33 minutes. By day 7, the mucosa was fully adherent with complete partitioning of the sinus and intracranial compartments. Fibroblast infiltration and flap neovascularization scores significantly increased between day 7 (0.3 ± 0.5 and 0.0 ± 0.0) and day 28 (4.0 ± 0.0, p = 0.01 and 2.0 ± 0.8, p = 0.01; respectively), while hemorrhage scores significantly decreased from 2.5 ± 0.6 to 0.0 ± 0.0 (p = 0.01). The inflammatory scores were not significantly different between the heterologous graft and control sides. The described sheep model accurately reflects prospective intranasal wound healing following vascularized mucosal reconstruction of dural defects. This model can be used in future studies to examine novel reconstructive materials, tissue glues, and transmucosal drug delivery to the central nervous system. © 2017 ARS-AAOA, LLC.

Cross-Cultural Adaptation and Validation of the FRAIL Scale to Assess Frailty in Mexican Adults.

PubMed

Rosas-Carrasco, Oscar; Cruz-Arenas, Esteban; Parra-Rodríguez, Lorena; García-González, Ana Isabel; Contreras-González, Luis Horacio; Szlejf, Claudia

2016-12-01

The objectives of this study were to cross-culturally adapt and validate the FRAIL scale in Mexican community-dwelling adults. Cross-sectional analysis of a prospective cohort. The FraDysMex study, a 2-round evaluation of community-dwelling adults from 2 municipalities in Mexico City. Participants were 606 men and women living in the designated area in Mexico City. Interviewers obtained data regarding demographics, comorbidities, mental status, nutritional status, dependency in activities of daily living, quality of life, mobility, balance, and strength. The FRAIL scale translated to Spanish and the Fried criteria were applied to screen frailty. The Mexican Spanish version of the FRAIL scale showed internal consistency (4 of 5 items in the scale correlated to the scale's total score, rho = 0.41-0.74), external consistency (interrater correlation CCI = 0.82), known-group validity based on age (9.6% of frailty in persons ≥50 years × 3.2% in persons <50 years, P = .001), convergent validity with the Fried criteria (CCI = 0.63), and the scale was also correlated with other measures related to frailty (such as age, quality of life, self-rated health status, cognition, dependency, nutritional status, depression, and physical performance). The FRAIL scale was successfully adapted to Mexican Spanish and validated in community-dwelling Mexican adults. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Validation of serum progesterone <35nmol/L as a predictor of miscarriage among women with threatened miscarriage.

PubMed

Lek, Sze Min; Ku, Chee Wai; Allen, John C; Malhotra, Rahul; Tan, Nguan Soon; Østbye, Truls; Tan, Thiam Chye

2017-03-06

Our recent paper, based on a pilot cohort of 119 women, showed that serum progesterone <35 nmol/L was prognostic of spontaneous miscarriage by 16 weeks in women with threatened miscarriage in early pregnancy. Using a larger cohort of women from the same setting (validation cohort), we aim to assess the validity of serum progesterone <35 nmol/L with the outcome of spontaneous miscarriage by 16 weeks. In a prospective cohort study, 360 pregnant women presenting with threatened miscarriage between gestation weeks 6-10 at a tertiary hospital emergency unit for women in Singapore were recruited for this study. The main outcome measure measured is spontaneous miscarriage prior to week 16 of gestation. Area under the ROC curve (AUC) and test characteristics (sensitivity, specificity, positive and negative predictive value) at a serum progesterone cutpoint of <35 nmol/L for predicting high and low risk of spontaneous miscarriage by 16 weeks were compared between the Pilot and Validation cohorts. Test characteristics and AUC values using serum progesterone <35 nmol/L in the validation cohort were not significantly different from those in the Pilot cohort, demonstrating excellent accuracy and reproducibility of the proposed serum progesterone cut-off level. The cut-off value for serum progesterone (35 nmol/L) demonstrated clinical relevance and allow clinicians to stratify patients into high and low risk groups for spontaneous miscarriage.

Coffee and tea consumption and the risk of ovarian cancer: a prospective cohort study and updated meta-analysis.

PubMed

Braem, Marieke G M; Onland-Moret, N Charlotte; Schouten, Leo J; Tjønneland, Anne; Hansen, Louise; Dahm, Christina C; Overvad, Kim; Lukanova, Annekatrin; Dossus, Laure; Floegel, Anna; Boeing, Heiner; Clavel-Chapelon, Francoise; Chabbert-Buffet, Nathalie; Fagherazzi, Guy; Trichopoulou, Antonia; Benetou, Vassiliki; Goufa, Ioulia; Pala, Valeria; Galasso, Rocco; Mattiello, Amalia; Sacerdote, Carlotta; Palli, Domenico; Tumino, Rosario; Gram, Inger T; Lund, Eiliv; Gavrilyuk, Oxana; Sánchez, Maria-José; Quirós, Ramón; Gonzales, Carlos A; Dorronsoro, Miren; Castaño, José M Huerta; Gurrea, Aurelio Barricarte; Idahl, Annika; Ohlson, Nina; Lundin, Eva; Jirstrom, Karin; Wirfalt, Elisabet; Allen, Naomi E; Tsilidis, Konstantinos K; Kaw, Kay-Tee; Bueno-de-Mesquita, H Bas; Dik, Vincent K; Rinaldi, Sabina; Fedirko, Veronika; Norat, Teresa; Riboli, Elio; Kaaks, Rudolf; Peeters, Petra H M

2012-05-01

In 2007 the World Cancer Research Fund Report concluded that there was limited and inconsistent evidence for an effect of coffee and tea consumption on the risk of epithelial ovarian cancer (EOC). In the European Prospective Investigation into Cancer and Nutrition (EPIC), we aimed to investigate whether coffee intakes, tea intakes, or both are associated with the risk of EOC. All women participating in the EPIC (n = 330,849) were included in this study. Data on coffee and tea consumption were collected through validated food-frequency questionnaires at baseline. HRs and 95% CIs were estimated by using Cox proportional hazards models. Furthermore, we performed an updated meta-analysis of all previous prospective studies until April 2011 by comparing the highest and lowest coffee- and tea-consumption categories as well as by using dose-response random-effects meta-regression analyses. During a median follow-up of 11.7 y, 1244 women developed EOC. No association was observed between the risk of EOC and coffee consumption [HR: 1.05 (95% CI: 0.75, 1.46) for the top quintile compared with no intake] or tea consumption [HR: 1.07 (95% CI: 0.78, 1.45) for the top quintile compared with no intake]. This lack of association between coffee and tea intake and EOC risk was confirmed by the results of our meta-analysis. Epidemiologic studies do not provide sufficient evidence to support an association between coffee and tea consumption and risk of ovarian cancer.

Effort-reward imbalance at work and 5-year changes in blood pressure: the mediating effect of changes in body mass index among 1400 white-collar workers.

PubMed

Trudel, Xavier; Brisson, Chantal; Milot, Alain; Masse, Benoit; Vézina, Michel

2016-11-01

A number of prospective studies have documented the effect of adverse psychosocial work factors (work stress) on high blood pressure (BP). Weight gain could be an important pathway by which work stress exerts its effect on BP. No previous prospective study has examined this mediating effect. The aim of the present study was to examine the mediating effect of body mass index (BMI) in the association between psychosocial work factors from Siegrist's effort-reward imbalance model (ERI) and ambulatory BP (ABP). A prospective study was conducted among 1436 white-collar workers. Data were collected three times during a 5-year period. ERI was measured using validated scales, at each time. BMI was measured by a trained assistant. ABP was measured every 15 min during a working day. ERI exposure onset over 3 years was indirectly associated with ABP changes (0.49 mmHg; 95 % CI 0.05, 1.22), through BMI changes, in women with baseline BMI ≥25 kg/m 2 . An effect of similar magnitude and of borderline significance was observed for ERI chronic exposure. No mediating effect was observed among men, and using ERI exposure over 5 years. The mediating effect of BMI was of small magnitude and observed in certain subgroups and time frame only. Subgroup-specific mediating pathways might be involved to explain the effect of work stress on cardiovascular diseases risk.

Perception and duration of pain after office-based vocal fold injection augmentation.

PubMed

Crawley, Brianna K; Dehom, Salem; Kutzner, Emily; Murry, Thomas; Krishna, Priya; Hata, Justin

2018-04-01

In-office laryngology procedures are important in the treatment of voice and swallowing disorders. Patient tolerance determines which procedures can be performed without sedation or formal anesthesia. This study examines pain perception during and after in-office vocal fold injection augmentation. Prospective cohort study. Patients scheduled for office-based vocal fold injection augmentation were prospectively enrolled at an academic voice center. The short-form McGill Pain Questionnaire was administered before, during, and after the procedure and on postprocedure days 1, 3, and 7. Pre- and postprocedure vital signs were recorded and heart rate was continuously monitored. Telephone questionnaires were completed on postprocedure days 1 and 3. Forty-five patients consented to participate in our study (24 males, mean age 61 years). Most patients experienced mild to moderate pain with increasing heart rate during the procedure. Pain remained or increased 20 minutes after the procedure and improved but persisted for 1 day. Sensory and affective discomfort was endorsed by the majority. A minority of patients experienced bruising and changes in swallowing with diet modification for 3 days after the procedure. Sixteen percent had discomfort after 1 week. This is the first prospective study examining patient perception of pain during and after in-office injection augmentation using a validated scale and pain descriptors with extended follow-up. The results may offer guidance for patient counseling, consent, and treatment to improve tolerance and success. 4. Laryngoscope, 128:929-934, 2018. © 2018 The American Laryngological, Rhinological and Otological Society, Inc.

China Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction: Study Design

PubMed Central

Li, Jing; Dreyer, Rachel P; Li, Xi; Du, Xue; Downing, Nicholas S; Li, Li; Zhang, Hai-Bo; Feng, Fang; Guan, Wen-Chi; Xu, Xiao; Li, Shu-Xia; Lin, Zhen-Qiu; Masoudi, Frederick A; Spertus, John A; Krumholz, Harlan M; Jiang, Li-Xin

2016-01-01

Background: Despite the rapid growth in the incidence of acute myocardial infarction (AMI) in China, there is limited information about patients’ experiences after AMI hospitalization, especially on long-term adverse events and patient-reported outcomes (PROs). Methods: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Prospective AMI Study will enroll 4000 consecutive AMI patients from 53 diverse hospitals across China and follow them longitudinally for 12 months to document their treatment, recovery, and outcomes. Details of patients’ medical history, treatment, and in-hospital outcomes are abstracted from medical charts. Comprehensive baseline interviews are being conducted to characterize patient demographics, risk factors, presentation, and healthcare utilization. As part of these interviews, validated instruments are administered to measure PROs, including quality of life, symptoms, mood, cognition, and sexual activity. Follow-up interviews, measuring PROs, medication adherence, risk factor control, and collecting hospitalization events are conducted at 1, 6, and 12 months after discharge. Supporting documents for potential outcomes are collected for adjudication by clinicians at the National Coordinating Center. Blood and urine samples are also obtained at baseline, 1- and 12-month follow-up. In addition, we are conducting a survey of participating hospitals to characterize their organizational characteristics. Conclusion: The China PEACE-Prospective AMI study will be uniquely positioned to generate new information regarding patient's experiences and outcomes after AMI in China and serve as a foundation for quality improvement activities. PMID:26712436

Obstructive sleep apnea exaggerates cognitive dysfunction in stroke patients.

PubMed

Zhang, Yan; Wang, Wanhua; Cai, Sijie; Sheng, Qi; Pan, Shenggui; Shen, Fang; Tang, Qing; Liu, Yang

2017-05-01

Obstructive sleep apnea (OSA) is very common in stroke survivors. It potentially worsens the cognitive dysfunction and inhibits their functional recovery. However, whether OSA independently damages the cognitive function in stroke patients is unclear. A simple method for evaluating OSA-induced cognitive impairment is also missing. Forty-four stroke patients six weeks after onset and 24 non-stroke patients with snoring were recruited for the polysomnographic study of OSA and sleep architecture. Their cognitive status was evaluated with a validated Chinese version of Cambridge Prospective Memory Test. The relationship between memory deficits and respiratory, sleeping, and dementia-related clinical variables were analyzed with correlation and multiple linear regression tests. OSA significantly and independently damaged time- and event-based prospective memory in stroke patients, although it had less power than the stroke itself. The impairment of prospective memory was correlated with increased apnea-hypopnea index, decreased minimal and mean levels of peripheral oxygen saturation, and disrupted sleeping continuity (reduced sleep efficiency and increased microarousal index). The further regression analysis identified minimal levels of peripheral oxygen saturation and sleep efficiency to be the two most important predictors for the decreased time-based prospective memory in stroke patients. OSA independently contributes to the cognitive dysfunction in stroke patients, potentially through OSA-caused hypoxemia and sleeping discontinuity. The prospective memory test is a simple but sensitive method to detect OSA-induced cognitive impairment in stroke patients. Proper therapies of OSA might improve the cognitive function and increase the life quality of stroke patients. Copyright © 2017 Elsevier B.V. All rights reserved.

Hesitant Fuzzy Thermodynamic Method for Emergency Decision Making Based on Prospect Theory.

PubMed

Ren, Peijia; Xu, Zeshui; Hao, Zhinan

2017-09-01

Due to the timeliness of emergency response and much unknown information in emergency situations, this paper proposes a method to deal with the emergency decision making, which can comprehensively reflect the emergency decision making process. By utilizing the hesitant fuzzy elements to represent the fuzziness of the objects and the hesitant thought of the experts, this paper introduces the negative exponential function into the prospect theory so as to portray the psychological behaviors of the experts, which transforms the hesitant fuzzy decision matrix into the hesitant fuzzy prospect decision matrix (HFPDM) according to the expectation-levels. Then, this paper applies the energy and the entropy in thermodynamics to take the quantity and the quality of the decision values into account, and defines the thermodynamic decision making parameters based on the HFPDM. Accordingly, a whole procedure for emergency decision making is conducted. What is more, some experiments are designed to demonstrate and improve the validation of the emergency decision making procedure. Last but not the least, this paper makes a case study about the emergency decision making in the firing and exploding at Port Group in Tianjin Binhai New Area, which manifests the effectiveness and practicability of the proposed method.

Psychometric Properties of the Consensus Sleep Diary in Those With Insomnia Disorder.

PubMed

Maich, Kristin H G; Lachowski, Angela M; Carney, Colleen E

2018-01-01

The Consensus Sleep Diary (CSD) is a standardized, prospective tool for tracking nightly subjective sleep. The current study evaluated the validity and utility of the CSD, with consideration for challenges inherent to psychometric evaluation of diary measures. Results showed that the CSD indices differentiated good sleepers from those with insomnia and were associated with similar objective indices and a subjective insomnia severity measure. The ability to detect treatment improvements after cognitive behavior therapy for insomnia (CBT-I) was tested by comparing pre- and post-CBT-I CSD indices with a subjective rating of insomnia symptom severity. Improvement in insomnia symptom severity was significantly related to improvement on the CSD indices. Completion rate of the CSD amongst participants across all 14 days was 99.8%. These findings provide support for the validity, clinical utility, and usability of the CSD.

Validated ¹H and 13C Nuclear Magnetic Resonance Methods for the Quantitative Determination of Glycerol in Drug Injections.

PubMed

Lu, Jiaxi; Wang, Pengli; Wang, Qiuying; Wang, Yanan; Jiang, Miaomiao

2018-05-15

In the current study, we employed high-resolution proton and carbon nuclear magnetic resonance spectroscopy (¹H and 13 C NMR) for quantitative analysis of glycerol in drug injections without any complex pre-treatment or derivatization on samples. The established methods were validated with good specificity, linearity, accuracy, precision, stability, and repeatability. Our results revealed that the contents of glycerol were convenient to calculate directly via the integration ratios of peak areas with an internal standard in ¹H NMR spectra, while the integration of peak heights were proper for 13 C NMR in combination with an external calibration of glycerol. The developed methods were both successfully applied in drug injections. Quantitative NMR methods showed an extensive prospect for glycerol determination in various liquid samples.

Prospective study on dietary intakes of folate, betaine, and choline and cardiovascular disease risk in women.

PubMed

Dalmeijer, G W; Olthof, M R; Verhoef, P; Bots, M L; van der Schouw, Y T

2008-03-01

To investigate the association between dietary intakes of folate, betaine and choline and the risk of cardiovascular disease (CVD). Prospective cohort study. A total of 16 165 women aged 49-70 years without prior CVD. SUBJECTS were breast cancer screening participants in the PROSPECT-EPIC cohort, which is 1 of the 2 Dutch contributions to the European Prospective Investigation into Cancer and Nutrition (EPIC). Each participant completed a validated food frequency questionnaire. Folate intake was calculated with the Dutch National Food Database. Betaine and choline intakes were calculated with the USDA database containing choline and betaine contents of common US foods. Data on coronary heart disease (CHD) events and cerebrovascular accident (CVA) events morbidity data were obtained from the Dutch Centre for Health Care Information. During a median follow-up period of 97 months, 717 women were diagnosed with CVD. After adjustment, neither folate, nor betaine, nor choline intakes were associated with CVD (hazard ratios for highest versus lowest quartile were 1.23 (95% confidence interval 0.75; 2.01), 0.90 (0.69; 1.17), 1.04 (0.71; 1.53), respectively). In a subsample of the population, high folate and choline intakes were statistically significantly associated with lower homocysteine levels. High betaine intake was associated with slightly lower high-density lipoprotein (HDL)-cholesterol concentrations. Regular dietary intakes of folate, betaine and choline were not associated with CVD risk in post-menopausal Dutch women. However, the effect of doses of betaine and choline beyond regular dietary intake--for example, via supplementation or fortification--remains unknown.

Evaluation of urinary resveratrol as a biomarker of dietary resveratrol intake in the European Prospective Investigation into Cancer and Nutrition (EPIC) study.

PubMed

Zamora-Ros, Raul; Rothwell, Joseph A; Achaintre, David; Ferrari, Pietro; Boutron-Ruault, Marie-Christine; Mancini, Francesca R; Affret, Aurelie; Kühn, Tilman; Katzke, Verena; Boeing, Heiner; Küppel, Sven; Trichopoulou, Antonia; Lagiou, Pagona; La Vecchia, Carlo; Palli, Domenico; Contiero, Paolo; Panico, Salvatore; Tumino, Rosario; Ricceri, Fulvio; Noh, Hwayoung; Freisling, Heinz; Romieu, Isabelle; Scalbert, Augustin

2017-06-01

In vitro studies have shown several beneficial properties of resveratrol. Epidemiological evidence is still scarce, probably because of the difficulty in estimating resveratrol exposure accurately. The current study aimed to assess the relationships between acute and habitual dietary resveratrol and wine intake and urinary resveratrol excretion in a European population. A stratified random subsample of 475 men and women from four countries participating in the European Prospective Investigation into Cancer and Nutrition (EPIC) cross-sectional study, who had provided 24-h urine samples and completed a 24-h dietary recall (24-HDR) on the same day, were included. Acute and habitual dietary data were collected using standardised 24-HDR software and a validated country-specific dietary questionnaire, respectively. Phenol-Explorer was used to estimate the intake of resveratrol and other stilbenes. Urinary resveratrol was analysed using tandem MS. Spearman's correlation coefficients between estimated dietary intakes of resveratrol and other stilbenes and consumption of wine, their main food source, were very high (r>0·9) when measured using dietary questionnaires and were slightly lower with 24-HDR (r>0·8). Partial Spearman's correlations between urinary resveratrol excretion and intake of resveratrol, total stilbenes or wine were found to be higher when using the 24-HDR (R 2 partial approximately 0·6) than when using the dietary questionnaires (R 2 partial approximately 0·5). Moderate to high correlations between dietary resveratrol, total stilbenes and wine, and urinary resveratrol concentrations were observed. These support the earlier findings that 24-h urinary resveratrol is an effective biomarker of both resveratrol and wine intakes. These correlations also support the validity of the estimation of resveratrol intake using the dietary questionnaire and Phenol-Explorer.

Multimodal navigated skull base tumor resection using image-based vascular and cranial nerve segmentation: A prospective pilot study

PubMed Central

Dolati, Parviz; Gokoglu, Abdulkerim; Eichberg, Daniel; Zamani, Amir; Golby, Alexandra; Al-Mefty, Ossama

2015-01-01

Background: Skull base tumors frequently encase or invade adjacent normal neurovascular structures. For this reason, optimal tumor resection with incomplete knowledge of patient anatomy remains a challenge. Methods: To determine the accuracy and utility of image-based preoperative segmentation in skull base tumor resections, we performed a prospective study. Ten patients with skull base tumors underwent preoperative 3T magnetic resonance imaging, which included thin section three-dimensional (3D) space T2, 3D time of flight, and magnetization-prepared rapid acquisition gradient echo sequences. Imaging sequences were loaded in the neuronavigation system for segmentation and preoperative planning. Five different neurovascular landmarks were identified in each case and measured for accuracy using the neuronavigation system. Each segmented neurovascular element was validated by manual placement of the navigation probe, and errors of localization were measured. Results: Strong correspondence between image-based segmentation and microscopic view was found at the surface of the tumor and tumor-normal brain interfaces in all cases. The accuracy of the measurements was 0.45 ± 0.21 mm (mean ± standard deviation). This information reassured the surgeon and prevented vascular injury intraoperatively. Preoperative segmentation of the related cranial nerves was possible in 80% of cases and helped the surgeon localize involved cranial nerves in all cases. Conclusion: Image-based preoperative vascular and neural element segmentation with 3D reconstruction is highly informative preoperatively and could increase the vigilance of neurosurgeons for preventing neurovascular injury during skull base surgeries. Additionally, the accuracy found in this study is superior to previously reported measurements. This novel preliminary study is encouraging for future validation with larger numbers of patients. PMID:26674155

Multimodal navigated skull base tumor resection using image-based vascular and cranial nerve segmentation: A prospective pilot study.

PubMed

Dolati, Parviz; Gokoglu, Abdulkerim; Eichberg, Daniel; Zamani, Amir; Golby, Alexandra; Al-Mefty, Ossama

2015-01-01

Skull base tumors frequently encase or invade adjacent normal neurovascular structures. For this reason, optimal tumor resection with incomplete knowledge of patient anatomy remains a challenge. To determine the accuracy and utility of image-based preoperative segmentation in skull base tumor resections, we performed a prospective study. Ten patients with skull base tumors underwent preoperative 3T magnetic resonance imaging, which included thin section three-dimensional (3D) space T2, 3D time of flight, and magnetization-prepared rapid acquisition gradient echo sequences. Imaging sequences were loaded in the neuronavigation system for segmentation and preoperative planning. Five different neurovascular landmarks were identified in each case and measured for accuracy using the neuronavigation system. Each segmented neurovascular element was validated by manual placement of the navigation probe, and errors of localization were measured. Strong correspondence between image-based segmentation and microscopic view was found at the surface of the tumor and tumor-normal brain interfaces in all cases. The accuracy of the measurements was 0.45 ± 0.21 mm (mean ± standard deviation). This information reassured the surgeon and prevented vascular injury intraoperatively. Preoperative segmentation of the related cranial nerves was possible in 80% of cases and helped the surgeon localize involved cranial nerves in all cases. Image-based preoperative vascular and neural element segmentation with 3D reconstruction is highly informative preoperatively and could increase the vigilance of neurosurgeons for preventing neurovascular injury during skull base surgeries. Additionally, the accuracy found in this study is superior to previously reported measurements. This novel preliminary study is encouraging for future validation with larger numbers of patients.

Assessing new terminal body and facial hair growth during pregnancy: toward developing a simplified visual scoring system for hirsutism.

PubMed

Yang, Yabo; Han, Yang; Wang, Wenjun; Du, Tao; Li, Yu; Zhang, Jianping; Yang, Dongzi; Zhao, Xiaomiao

2016-02-01

To study the distribution and progression of terminal hair growth in pregnant women and to determine the feasibility of a simplified scoring system for assessing hirsutism. Prospective follow-up observational study. Academic hospital. A total of 115 pregnant women (discovery cohort) and 1,159 women with polycystic ovary syndrome (PCOS) (validation cohort). Facial and body terminal hair growth assessed by modified Ferriman and Gallwey score system (mFG score), and total testosterone (TT) level detected by liquid chromatography with tandem mass spectrometry. Degree of facial and body terminal hair growth. The serum TT level and mFG score increased as pregnancy progressed. Both the prospective study and receiver operating characteristics curve indicated that the body areas with the greatest contribution to hirsutism (defined as an mFG score ≥5) with new terminal hair growth were the upper lip, lower back, lower abdomen, and thigh. A simplified mFG scoring system (sFG) was developed, and a cutoff value of ≥3 was defined as hirsutism. Pregnant hirsute women were distinguished from nonhirsute women with an accuracy of 95.2%, sensitivity of 96.8%, and specificity of 94.3% for detecting hirsutism. This was further validated in the PCOS population with a sensitivity, specificity, and positive predictive value of 97.6%, 96.4%, and 96.4%, respectively. This study suggests that the upper lip, lower back, lower abdomen, and thigh may be an effective simplified combination of the mFG system for the evaluation of excess hair growth in Chinese women. ChiCTR-OCH-14005012. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

The impact of childhood acute rotavirus gastroenteritis on the parents’ quality of life: prospective observational study in European primary care medical practices

PubMed Central

2012-01-01

Background Rotavirus (RV) is the commonest cause of acute gastroenteritis in infants and young children worldwide. A Quality of Life study was conducted in primary care in three European countries as part of a larger epidemiological study (SPRIK) to investigate the impact of paediatric rotavirus gastroenteritis (RVGE) on affected children and their parents. Methods A self-administered questionnaire was linguistically validated in Spanish, Italian and Polish. The questionnaire was included in an observational multicentre prospective study of 302 children aged <5 years presenting to a general practitioner or paediatrician for RVGE at centres in Spain, Italy or Poland. RV infection was confirmed by polymerase chain reaction (PCR) testing (n = 264). The questionnaire was validated and used to assess the emotional impact of paediatric RVGE on the parents. Results Questionnaire responses showed that acute RVGE in a child adversely affects the parents’ daily life as well as the child. Parents of children with RVGE experience worry, distress and impact on their daily activities. RVGE of greater clinical severity (assessed by the Vesikari scale) was associated with higher parental worries due to symptoms and greater changes in the child’s behaviour, and a trend to higher impact on parents’ daily activities and higher parental distress, together with a higher score on the symptom severity scale of the questionnaire. Conclusions Parents of a child with acute RVGE presenting to primary care experience worry, distress and disruptions to daily life as a result of the child’s illness. Prevention of this disease through prophylactic vaccination will improve the daily lives of parents and children. PMID:22650611

Can a quality-of-life assessment assist in identifying women at risk of prematurely discontinuing IVF treatment? A prospective cohort study utilizing the FertiQoL questionnaire.

PubMed

Neumann, Kay; Kayser, Janna; Depenbusch, Marion; Schultze-Mosgau, Askan; Griesinger, Georg

2018-07-01

This study aimed at assessing quality of life (QoL) by means of a validated measurement tool (FertiQoL) in German infertile patients before a first IVF/ICSI cycle with ancillary assessment of changes in FertiQoL scores after a failed first cycle and the predictive capacity of FertiQoL scores for treatment discontinuation. The validated FertiQoL tool consisting of 24 questions regarding fertility-specific aspects of QoL was used for this prospective cohort study conducted at a university affiliated IVF center in Germany. Female patients (n = 119) filled out the FertiQoL form and questionnaire on sociodemographic variables on initiation of a first- and second-cycle IVF/ICSI treatment, respectively. On initiation of a first IVF/ICSI cycle, the mean scores (± standard deviation) for subscales emotional, mind-body, relational, and social items were 62 (± 19), 75 (± 17), 82 (± 13), and 78 (± 14), respectively; the total FertiQoL score was 73 (± 12). The mean total FertiQoL score at initiation of a first treatment cycle did not differ between patients who continued vs. discontinued treatment in case of no pregnancy achievement in the first cycle (73) (± 10) vs. 74 (± 14), p = 0.46). Furthermore, the mean total FertiQoL score did not change after an unsuccessful first IVF cycle (74 vs. 76, p = 0.46). There was no statistical difference in a small sample size for FertiQoL scores between all groups. In this study, FertiQoL scores were, therefore, not usable to predict withdrawal from infertility treatment.

Prospective and clinical validation of ALK immunohistochemistry: results from the phase I/II study of alectinib for ALK-positive lung cancer (AF-001JP study)

PubMed Central

Takeuchi, K.; Togashi, Y.; Kamihara, Y.; Fukuyama, T.; Yoshioka, H.; Inoue, A.; Katsuki, H.; Kiura, K.; Nakagawa, K.; Seto, T.; Maemondo, M.; Hida, T.; Harada, M.; Ohe, Y.; Nogami, N.; Yamamoto, N.; Nishio, M.; Tamura, T.

2016-01-01

Background Anaplastic lymphoma kinase (ALK) fusions need to be accurately and efficiently detected for ALK inhibitor therapy. Fluorescence in situ hybridization (FISH) remains the reference test. Although increasing data are supporting that ALK immunohistochemistry (IHC) is highly concordant with FISH, IHC screening needed to be clinically and prospectively validated. Patients and methods In the AF-001JP trial for alectinib, 436 patients were screened for ALK fusions through IHC (n = 384) confirmed with FISH (n = 181), multiplex RT-PCR (n = 68), or both (n = 16). IHC results were scored with iScore. Result ALK fusion was positive in 137 patients and negative in 250 patients. Since the presence of cancer cells in the samples for RT-PCR was not confirmed, ALK fusion negativity could not be ascertained in 49 patients. IHC interpreted with iScore showed a 99.4% (173/174) concordance with FISH. All 41 patients who had iScore 3 and were enrolled in phase II showed at least 30% tumor reduction with 92.7% overall response rate. Two IHC-positive patients with an atypical FISH pattern responded to ALK inhibitor therapy. The reduction rate was not correlated with IHC staining intensity. Conclusions Our study showed (i) that when sufficiently sensitive and appropriately interpreted, IHC can be a stand-alone diagnostic for ALK inhibitor therapies; (ii) that when atypical FISH patterns are accompanied by IHC positivity, the patients should be considered as candidates for ALK inhibitor therapies, and (iii) that the expression level of ALK fusion is not related to the level of response to ALK inhibitors and is thus not required for patient selection. Registration number JapicCTI-101264 (This study is registered with the Japan Pharmaceutical Information Center). PMID:26487585

A prospective study to validate various clinical criteria used in classification of leprosy: a study from a tertiary care center in India.

PubMed

Thapa, Manisha; Sendhil Kumaran, Muthu; Narang, Tarun; Saikia, Uma N; Sawatkar, Gitesh U; Dogra, Sunil

2018-05-29

Various clinical criteria are used to categorize leprosy patients into paucibacillary (PB) and multibacillary (MB), thus aiding in appropriate treatment. However, comprehensive studies validating these criteria are minimal. To assess sensitivity and specificity of different clinical criteria individually and in combination for classifying leprosy into PB/MB spectrum. A prospective study was conducted wherein 50 newly diagnosed, untreated leprosy cases were recruited and classified into PB and MB using the following clinical criteria: number of skin lesions (NSL), number of body areas affected (NBAA), and size of largest skin lesion (SLSL). Patients with pure neuritic leprosy, diffuse macular type of lepromatous leprosy, and with reactions were excluded. Sensitivity and specificity of these clinical criteria in classification was calculated taking histopathological findings as gold standard. Among 50 patients, 37 were males and 13 were females with a mean age of 32.08 ± 16.55 years. The sensitivity and specificity of NSL, NBAA, and SLSL was 94.74 and 87.1%, 94.74 and 61.29%, and 73.68 and 16.13%, respectively. Combining all three criteria, the sensitivity increased to 100%, but specificity decreased drastically to 12.9%. The ROC curve for NSL, NBAA, and SLSL showed a cutoff of ≥6 skin lesions, ≥3 body areas affected, and ≤2 cm lesion to classify as MB. The current WHO system of leprosy classification based on NSL seems to be best among available clinical criteria. Uniform and sensible application of this criteria itself assures appropriate categorizing and leprosy treatment with reasonable sensitivity and specificity. © 2018 The International Society of Dermatology.

Validation of the "Step-by-Step" Approach in the Management of Young Febrile Infants.

PubMed

Gomez, Borja; Mintegi, Santiago; Bressan, Silvia; Da Dalt, Liviana; Gervaix, Alain; Lacroix, Laurence

2016-08-01

A sequential approach to young febrile infants on the basis of clinical and laboratory parameters, including procalcitonin, was recently described as an accurate tool in identifying patients at risk for invasive bacterial infection (IBI). Our aim was to prospectively validate the Step-by-Step approach and compare it with the Rochester criteria and the Lab-score. Prospective study including infants ≤90 days with fever without source presenting in 11 European pediatric emergency departments between September 2012 and August 2014. The accuracy of the Step-by-Step approach, the Rochester criteria, and the Lab-score in identifying patients at low risk of IBI (isolation of a bacterial pathogen in a blood or cerebrospinal fluid culture) was compared. Eighty-seven of 2185 infants (4.0%) were diagnosed with an IBI. The prevalence of IBI was significantly higher in infants classified as high risk or intermediate risk according to the Step by Step than in low risk patients. Sensitivity and negative predictive value for ruling out an IBI were 92.0% and 99.3% for the Step by Step, 81.6% and 98.3% for the Rochester criteria, and 59.8% and 98.1% for the Lab-score. Seven infants with an IBI were misclassified by the Step by Step, 16 by Rochester criteria, and 35 by the Lab-score. We validated the Step by Step as a valuable tool for the management of infants with fever without source in the emergency department and confirmed its superior accuracy in identifying patients at low risk of IBI, compared with the Rochester criteria and the Lab-score. Copyright © 2016 by the American Academy of Pediatrics.

Validation of the Spanish version of the Test for Respiratory and Asthma Control in Kids (TRACK) in a population of Hispanic preschoolers.

PubMed

Rodríguez-Martínez, Carlos E; Nino, Gustavo; Castro-Rodriguez, Jose A

2014-01-01

There is a critical need for validation studies of questionnaires designed to assess the level of control of asthma in children younger than 5 years old. To validate the Spanish version of the Test for Respiratory and Asthma Control in Kids (TRACK) questionnaire in children younger than age 5 years with symptoms consistent with asthma. In a prospective cohort validation study, parents and/or caregivers of children younger than age 5 years and with symptoms consistent with asthma, during a baseline and a follow-up visit 2 to 6 weeks later, completed the information required to assess the content validity, criterion validity, construct validity, test-retest reliability, sensitivity to change, internal consistency reliability, and usability of the TRACK questionnaire. Median (interquartile range) of the TRACK scores were significantly different between patients with well-controlled asthma, patients with not well-controlled asthma, and patients with very poorly controlled asthma (90.0 [75.0-95.0], 75.0 [55.0-85.0], and 35.0 [25.0-55.0], respectively, P < .001). TRACK scores were significantly different between patients classified as currently symptomatic and symptomatic in the recent past (42.5 [25.0-55.0] vs 85.0 [75.0-90.0]; P < .001). The intraclass correlation coefficient of the measurements was 0.755 (95% CI, 0.503-1.00). All patients whose clinical status changed showed an increase of 10 or more points in TRACK score between baseline and follow-up visits. The Cronbach α was 0.77 for the questionnaire as a whole. The Spanish version of the TRACK questionnaire has excellent sensitivity to change and usability; adequate criterion validity, construct validity, and test-retest reliability; and an acceptable internal consistency, when used in children younger than age 5 years with symptoms consistent with asthma. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Early Prediction of Intensive Care Unit-Acquired Weakness: A Multicenter External Validation Study.

PubMed

Witteveen, Esther; Wieske, Luuk; Sommers, Juultje; Spijkstra, Jan-Jaap; de Waard, Monique C; Endeman, Henrik; Rijkenberg, Saskia; de Ruijter, Wouter; Sleeswijk, Mengalvio; Verhamme, Camiel; Schultz, Marcus J; van Schaik, Ivo N; Horn, Janneke

2018-01-01

An early diagnosis of intensive care unit-acquired weakness (ICU-AW) is often not possible due to impaired consciousness. To avoid a diagnostic delay, we previously developed a prediction model, based on single-center data from 212 patients (development cohort), to predict ICU-AW at 2 days after ICU admission. The objective of this study was to investigate the external validity of the original prediction model in a new, multicenter cohort and, if necessary, to update the model. Newly admitted ICU patients who were mechanically ventilated at 48 hours after ICU admission were included. Predictors were prospectively recorded, and the outcome ICU-AW was defined by an average Medical Research Council score <4. In the validation cohort, consisting of 349 patients, we analyzed performance of the original prediction model by assessment of calibration and discrimination. Additionally, we updated the model in this validation cohort. Finally, we evaluated a new prediction model based on all patients of the development and validation cohort. Of 349 analyzed patients in the validation cohort, 190 (54%) developed ICU-AW. Both model calibration and discrimination of the original model were poor in the validation cohort. The area under the receiver operating characteristics curve (AUC-ROC) was 0.60 (95% confidence interval [CI]: 0.54-0.66). Model updating methods improved calibration but not discrimination. The new prediction model, based on all patients of the development and validation cohort (total of 536 patients) had a fair discrimination, AUC-ROC: 0.70 (95% CI: 0.66-0.75). The previously developed prediction model for ICU-AW showed poor performance in a new independent multicenter validation cohort. Model updating methods improved calibration but not discrimination. The newly derived prediction model showed fair discrimination. This indicates that early prediction of ICU-AW is still challenging and needs further attention.

Validity and Reliability of Visual Analog Scaling for Assessment of Hypernasality and Audible Nasal Emission in Children With Repaired Cleft Palate.

PubMed

Baylis, Adriane; Chapman, Kathy; Whitehill, Tara L; Group, The Americleft Speech

2015-11-01

To investigate the validity and reliability of multiple listener judgments of hypernasality and audible nasal emission, in children with repaired cleft palate, using visual analog scaling (VAS) and equal-appearing interval (EAI) scaling. Prospective comparative study of multiple listener ratings of hypernasality and audible nasal emission. Multisite institutional. Five trained and experienced speech-language pathologist listeners from the Americleft Speech Project. Average VAS and EAI ratings of hypernasality and audible nasal emission/turbulence for 12 video-recorded speech samples from the Americleft Speech Project. Intrarater and interrater reliability was computed, as well as linear and polynomial models of best fit. Intrarater and interrater reliability was acceptable for both rating methods; however, reliability was higher for VAS as compared to EAI ratings. When VAS ratings were plotted against EAI ratings, results revealed a stronger curvilinear relationship. The results of this study provide additional evidence that alternate rating methods such as VAS may offer improved validity and reliability over EAI ratings of speech. VAS should be considered a viable method for rating hypernasality and nasal emission in speech in children with repaired cleft palate.

The Drell-Yan Process

DOE PAGES

Peng, Jen -Chieh; Qiu, Jian -Wei

2016-09-01

The Drell-Yan process, proposed over 45 years ago by Sid Drell and Tung-Mow Yan to describe high-mass lepton-pair production in hadron-hadron collision, has played an important role in validating QCD as the correct theory for strong interaction. This process has also become a powerful tool for probing the partonic structures of hadrons. The Drell-Yan mechanism has led to the discovery of new particles, and will continue to be an important tool to search for new physics. In this study, we review some highlights and future prospects of the Drell-Yan process.