Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

PubMed

Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

2015-08-11

The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively. Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.

Predicting factors of fistula healing and clinical remission after infliximab-based combined therapy for perianal fistulizing Crohn's disease.

PubMed

Tougeron, David; Savoye, Guillaume; Savoye-Collet, Céline; Koning, Edith; Michot, Francis; Lerebours, Eric

2009-08-01

Perianal fistulizing Crohn's disease (PFCD) treatment is based on fistula drainage, antibiotics, immunosuppressant (IS) drugs, and infliximab. Our aim was to study the effectiveness of combination therapy on PFCD and to search for clinical or imaging features associated with the initial complete clinical response and its stability overtime. All patients with PFCD treated in our tertiary center between 2000 and 2005 by infliximab in combination with seton placement and/or IS and evaluated by MRI before treatment were included in the study. Basal clinical and MRI characteristics were recorded. Response to treatment was evaluated after the infliximab induction regiment and at the end of the follow-up. Twenty-six patients were included and followed-up for an average 4.9 years. A complex fistula was present in 69% (18/26 patients) of cases and eight (8/26 patients) had an ano-vaginal fistula. After infliximab induction therapy, 13 patients (50%) achieved a complete clinical response. The initial clinical response was significantly associated with the absence of both, active intestinal disease (54% vs. 8%, P = 0.03) and active proctitis (77% vs. 23%, P = 0.01). No initial MRI characteristics were linked to the initial response. In multivariate analysis, only the presence of active proctitis was associated with the lack of response (P = 0.047). At the end of the follow-up, 42% of the patients remained in clinical remission. No clinical characteristics were associated to sustained response when among long-standing responders two exhibited a normal post-treatment MRI. An initial complete response of PFCD was observed in half of the patients after combined therapy including infliximab that decreased to 42% later on. Complete healing of fistulas on MRI was possible but unusual. The initial response seemed related to the absence of active intestinal disease, especially in the rectum, when the long-term response could not be predicted by the basal characteristics of patients.

Pre-cART Elevation of CRP and CD4+ T-Cell Immune Activation Associated With HIV Clinical Progression in a Multinational Case-Cohort Study.

PubMed

Balagopal, Ashwin; Asmuth, David M; Yang, Wei-Teng; Campbell, Thomas B; Gupte, Nikhil; Smeaton, Laura; Kanyama, Cecilia; Grinsztejn, Beatriz; Santos, Breno; Supparatpinyo, Khuanchai; Badal-Faesen, Sharlaa; Lama, Javier R; Lalloo, Umesh G; Zulu, Fatima; Pawar, Jyoti S; Riviere, Cynthia; Kumarasamy, Nagalingeswaran; Hakim, James; Li, Xiao-Dong; Pollard, Richard B; Semba, Richard D; Thomas, David L; Bollinger, Robert C; Gupta, Amita

2015-10-01

Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore, some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical progression in cART initiators. A case-cohort study (n = 470) within the multinational Prospective Evaluation of Antiretrovirals in Resource-Limited Settings clinical trial (1571 HIV treatment-naive adults who initiated cART; CD4 T-cell count <300 cells/mm; 9 countries) was conducted. A subcohort of 30 participants per country was randomly selected; additional cases were added from the main cohort. Cases [n = 236 (random subcohort 36; main cohort 200)] had clinical progression (incident WHO stage 3/4 event or death) within 96 weeks after cART initiation. Immune activation biomarkers were quantified pre-cART. Associations between biomarkers and clinical progression were examined using weighted multivariable Cox-proportional hazards models. Median age was 35 years, 45% were women, 49% black, 31% Asian, and 9% white. Median CD4 T-cell count was 167 cells per cubic millimeter. In multivariate analysis, highest quartile C-reactive protein concentration [adjusted hazard ratio (aHR), 2.53; 95% confidence interval (CI): 1.02 to 6.28] and CD4 T-cell activation (aHR, 5.18; 95% CI: 1.09 to 24.47) were associated with primary outcomes, compared with lowest quartiles. sCD14 had a trend toward association with clinical failure (aHR, 2.24; 95% CI: 0.96 to 5.21). Measuring C-reactive protein and CD4 T-cell activation may identify patients with CD4 T-cell counts <300 cells per cubic millimeter at risk for early clinical progression when initiating cART. Additional vigilance and symptom-based screening may be required in this subset of patients even after beginning cART.

Pre-cART Elevation of CRP and CD4+ T-cell Immune Activation Associated with HIV Clinical Progression in a Multinational Case-Cohort Study

PubMed Central

Balagopal, Ashwin; Asmuth, David M.; Yang, Wei-Teng; Campbell, Thomas B.; Gupte, Nikhil; Smeaton, Laura; Kanyama, Cecilia; Grinsztejn, Beatriz; Santos, Breno; Supparatpinyo, Khuanchai; Badal-Faesen, Sharlaa; Lama, Javier R.; Lalloo, Umesh G.; Zulu, Fatima; Pawar, Jyoti S; Riviere, Cynthia; Kumarasamy, Nagalingeswaran; Hakim, James; Li, Xiao-Dong; Pollard, Richard B.; Semba, Richard D.; Thomas, David L.; Bollinger, Robert C.; Gupta, Amita

2015-01-01

Background Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical progression in cART initiators. Methods A case-cohort study (n=470) within the multinational Prospective Evaluation of Antiretrovirals in Resource-Limited Settings (PEARLS) clinical trial (1571 HIV treatment-naïve adults who initiated cART; CD4+ T cell count <300 cells/mm3; nine countries) was conducted. A subcohort of 30 participants/country was randomly selected; additional cases were added from the main cohort. Cases (n=236 [random subcohort–36; main cohort–200]) had clinical progression (incident WHO Stage 3/4 event or death) within 96 weeks following cART initiation. Immune activation biomarkers were quantified pre-cART. Associations between biomarkers and clinical progression were examined using weighted multivariable Cox-proportional hazards models. Results Median age was 35 years, 45% were women, 49% black, 31% Asian, and 9% white. Median CD4+ T-cell count was 167 cells/mm3. In multivariate analysis, highest quartile CRP concentration (adjusted hazards ratio [aHR] 2.53, 95%CI 1.02-6.28) and CD4+ T-cell activation (aHR 5.18, 95CI 1.09-24.47) were associated with primary outcomes, compared to lowest quartiles. sCD14 had a trend towards association with clinical failure (aHR 2.24, 95%CI 0.96–5.21). Conclusions Measuring CRP and CD4+ T-cell activation may identify patients with CD4+ T cell counts < 300 cells/mm3 at risk for early clinical progression when initiating cART. Additional vigilance and symptom-based screening may be required in this subset of patients even after beginning cART. PMID:26017661

Using systems thinking to support clinical system transformation.

PubMed

Best, Allan; Berland, Alex; Herbert, Carol; Bitz, Jennifer; van Dijk, Marlies W; Krause, Christina; Cochrane, Douglas; Noel, Kevin; Marsden, Julian; McKeown, Shari; Millar, John

2016-05-16

Purpose - The British Columbia Ministry of Health's Clinical Care Management initiative was used as a case study to better understand large-scale change (LSC) within BC's health system. Using a complex system framework, the purpose of this paper is to examine mechanisms that enable and constrain the implementation of clinical guidelines across various clinical settings. Design/methodology/approach - Researchers applied a general model of complex adaptive systems plus two specific conceptual frameworks (realist evaluation and system dynamics mapping) to define and study enablers and constraints. Focus group sessions and interviews with clinicians, executives, managers and board members were validated through an online survey. Findings - The functional themes for managing large-scale clinical change included: creating a context to prepare clinicians for health system transformation initiatives; promoting shared clinical leadership; strengthening knowledge management, strategic communications and opportunities for networking; and clearing pathways through the complexity of a multilevel, dynamic system. Research limitations/implications - The action research methodology was designed to guide continuing improvement of implementation. A sample of initiatives was selected; it was not intended to compare and contrast facilitators and barriers across all initiatives and regions. Similarly, evaluating the results or process of guideline implementation was outside the scope; the methods were designed to enable conversations at multiple levels - policy, management and practice - about how to improve implementation. The study is best seen as a case study of LSC, offering a possible model for replication by others and a tool to shape further dialogue. Practical implications - Recommended action-oriented strategies included engaging local champions; supporting local adaptation for implementation of clinical guidelines; strengthening local teams to guide implementation; reducing change fatigue; ensuring adequate resources; providing consistent communication especially for front-line care providers; and supporting local teams to demonstrate the clinical value of the guidelines to their colleagues. Originality/value - Bringing a complex systems perspective to clinical guideline implementation resulted in a clear understanding of the challenges involved in LSC.

Timing of dialysis initiation, duration and frequency of hemodialysis sessions, and membrane flux: a systematic review for a KDOQI clinical practice guideline.

PubMed

Slinin, Yelena; Greer, Nancy; Ishani, Areef; MacDonald, Roderick; Olson, Carin; Rutks, Indulis; Wilt, Timothy J

2015-11-01

In 2006, NKF-KDOQI (National Kidney Foundation-Kidney Disease Outcomes Quality Initiative) published clinical practice guidelines for hemodialysis adequacy. Recent studies evaluating hemodialysis adequacy as determined by initiation timing, frequency, duration, and membrane type and prompted an update to the guideline. Systematic review and evidence synthesis. Patients with advanced chronic kidney disease receiving hemodialysis. We screened publications from 2000 to March 2014, systematic reviews, and references and consulted the NKF-KDOQI Hemodialysis Adequacy Work Group members. We included randomized or controlled clinical trials in patients undergoing long-term hemodialysis if they reported outcomes of interest. Early versus late dialysis therapy initiation; more frequent (>3 times a week) or longer duration (>4.5 hours) compared to conventional hemodialysis; low- versus high-flux dialyzer membranes. All-cause and cardiovascular mortality, myocardial infarction, stroke, hospitalizations, quality of life, depression or cognitive function scores, blood pressure, number of antihypertensive medications, left ventricular mass, interdialytic weight gain, and harms or complications related to vascular access or the process of dialysis. We included 32 articles reporting on 19 trials. Moderate-quality evidence indicated that earlier dialysis therapy initiation (at estimated creatinine clearance [eClcr] of 10-14mL/min) did not reduce mortality compared to later initiation (eClcr of 5-7mL/min). More than thrice-weekly hemodialysis and extended-length hemodialysis during a short follow-up did not improve clinical outcomes compared to conventional hemodialysis and resulted in a greater number of vascular access procedures (very low-quality evidence). Hemodialysis using high-flux membranes did not reduce all-cause mortality, but reduced cardiovascular mortality compared to hemodialysis using low-flux membranes (moderate-quality evidence). Few studies were adequately powered to evaluate mortality. Heterogeneity of study designs and interventions precluded pooling data for most outcomes. Limited data indicate that earlier dialysis therapy initiation and more frequent and longer hemodialysis did not improve clinical outcomes compared to conventional hemodialysis. Published by Elsevier Inc.

Effects of pill burden on discontinuation of the initial HAART regimen in minority female patients prescribed 1 pill/day versus any other pill burden.

PubMed

Hill, Seth; Kavookjian, Jan; Qian, Jingjing; Chung, Allison; Vandewaa, John

2014-01-01

Highly active antiretroviral therapy (HAART) is a mainstay of treatment for patients with Human Immunodeficiency Virus (HIV). Since second line HAART therapies can be costlier and less effective, it is essential to understand the duration of initial HAART therapies. The overall aim of this study was to estimate the effects of daily pill burden on the time to discontinuation of the initial HAART regimen. Patients were initially identified through the clinic's CAREWARE database. A chart review was conducted for data collection, where only adult, female, HIV-positive patients initiating therapy at the study clinic between 1 January 2001 and 31 December 2011 were included. All study subjects were followed up from the initiation of HAART to treatment discontinuation. A Kaplan-Meier curve was generated to describe time to discontinuation by regimens, and a Cox proportional hazards model was developed to assess the impact of different regimen and patient demographic characteristics on the hazard of discontinuation of the initial regimen. A total of 498 charts were initially reviewed. After assessment of these patients for inclusion criteria, a cohort of 115 adult female patients who initiated HAART at the study clinic was included. Patients treated with 1 pill/day regimen had a significantly longer time to discontinuation than regimens of >1 pills/day (mean duration of initial therapy was 1062.56 days vs. 631.70 days, respectively, p = 0.003). Compared to 1 pill/day regimens, >1 pills/day regimens were associated with a higher hazard of discontinuation (hazard ratio (HR) =3.44 with 95% confidence interval (CI) = 1.25, 9.48). A higher viral load and patients without insurance were also found to be significantly associated with increased hazards of discontinuation. Overall, female HIV patients initiating therapy with the 1 pill/day HAART regimen were less likely to discontinue their treatment compared to patients initiating with >1 pills/day HAART regimen.

The Illinois Articulation Initiative Major Fields Panels' Recommendations for Business, Clinical Laboratory Science, Education--Early Childhood, Education--Elementary, Education--Secondary, Music, Nursing, Psychology.

ERIC Educational Resources Information Center

Illinois Community Coll. Board, Springfield.

Developed by the Illinois Articulation Initiative (IAI), this report provides recommendations for improving articulation through state high schools, community colleges, and institutions of higher education. The recommendations are presented by field of study for business, clinical laboratory science, early childhood education, elementary…

Clinical utility of histological features of polyomavirus allograft nephropathy.

PubMed

Gaber, Lillian W; Egidi, M Francesca; Stratta, Robert J; Lo, Agnes; Moore, Linda W; Gaber, A Osama

2006-07-27

The purpose of this study was to determine if histological features of polyomavirus allograft nephropathy (PVAN) are associated with the clinical presentation and outcomes of PVAN. We examined the histological features of initial and follow-up biopsies of 20 kidney and kidney-pancreas transplant recipients with PVAN during a time prior to routine surveillance. The subjects' demographics, clinical characteristics, and outcomes were compared based upon classification of histological features of PVAN on initial biopsy. Diabetes mellitus (45%) and a history of tacrolimus-induced nephrotoxicity (35%) appeared to be prevalent in subjects with PVAN. Although histological severity of PVAN did not predict or correlate with the clinical course of PVAN, subjects with pattern C on initial PVAN biopsy presented later posttransplant, had higher serum creatinine level at presentation, and had significant allograft deterioration at follow-up than subjects with either pattern A or B on initial biopsy. Resolution of PVAN was noted in 60% of follow-up biopsies and occurred more frequently in subjects with pattern B on initial biopsy. Most subjects developed chronic allograft nephropathy after PVAN and viral clearance did not abrogate the progression to chronic allograft nephropathy. These data indicate that histologic patterns of PVAN may have clinical correlation to disease presentation and prognosis.

Videoconferencing for site initiations in clinical studies: Mixed methods evaluation of usability, acceptability, and impact on recruitment.

PubMed

Randell, Rebecca; Backhouse, Michael R; Nelson, E Andrea

2016-12-01

A critical issue for multicentre clinical studies is conducting site initiations, ensuring sites are trained in study procedures and comply with relevant governance requirements before they begin recruiting patients. How technology can support site initiations has not previously been explored. This study sought to evaluate use of off-the-shelf web-based videoconferencing to deliver site initiations for a large national multicentre study. Participants in the initiations, including podiatrists, diabetologists, trial coordinators, and research nurses, completed an online questionnaire based on the System Usability Scale (SUS) (N = 15). This was followed by semi-structured interviews, with a consultant diabetologist, a trial coordinator, and three research nurses, exploring perceived benefits and limitations of videoconferencing. The mean SUS score for the videoconferencing platform was 87.2 (SD = 13.7), suggesting a good level of usability. Interview participants perceived initiations delivered by videoconferencing as being more interactive and easier to follow than those delivered by teleconference. In comparison to face-to-face initiations, videoconferencing takes less time, easily fitting in with the work of staff at the local sites. Perceptions of impact on communication varied according to the hardware used. Off-the-shelf videoconferencing is a viable alternative to face-to-face site initiations and confers advantages over teleconferencing.

Dropout revisited: patient- and therapist-initiated discontinuation of psychotherapy as a function of organizational instability.

PubMed

Werbart, Andrzej; Andersson, Håkan; Sandell, Rolf

2014-01-01

To explore the association between the stability or instability of services' organizational structure and patient- and therapist-initiated discontinuation of therapy in routine mental health. Three groups, comprising altogether 750 cases in routine mental health care in eight different clinics, were included: cases with patient-initiated discontinuation, therapist-initiated discontinuation, and patients remaining in treatment. Multilevel multinomial regression was used to estimate three models: An initial, unconditional intercept-only model, another one including patient variables, and a final model with significant patient and therapist variables including the organizational stability of the therapists' clinic. High between-therapist variability was noted. Odds ratios and significance tests indicated a strong association of organizational instability with patient-initiated premature termination in particular. The question of how organizational factors influence the treatment results needs further research. Future studies have to be designed in ways that permit clinically meaningful subdivision of the patients' and the therapists' decisions for premature termination.

Completed | Office of Cancer Clinical Proteomics Research

Cancer.gov

Prior to the current Clinical Proteomic Tumor Analysis Consortium (CPTAC), previously funded initiatives associated with clinical proteomics research included: Clinical Proteomic Tumor Analysis Consortium (CPTAC 2.0) Clinical Proteomic Technologies for Cancer Initiative (CPTC) Mouse Proteomic Technologies Initiative

Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study.

PubMed

Janz, N K; Wren, P A; Lichter, P R; Musch, D C; Gillespie, B W; Guire, K E

2001-05-01

The Collaborative Initial Glaucoma Treatment Study (CIGTS) was designed to determine whether patients with newly diagnosed open-angle glaucoma are better treated initially by medicine or immediate filtering surgery. This paper describes the quality-of-life (QOL) measurement approach, instruments included, and the CIGTS participants' QOL findings at the time of diagnosis. Baseline results from a randomized, controlled clinical trial. Six hundred seven patients from 14 clinical centers were enrolled. Patients randomized to initial medication received a stepped medical regimen (n = 307). Those randomized to initial surgery underwent a trabeculectomy (n = 300). The baseline interview was conducted before treatment initiation. All baseline and posttreatment QOL assessments were conducted by telephone from a centralized interviewing center. The primary outcome measure described in this paper was QOL. The QOL instrument is multidimensional and incorporates both disease-specific and generic measures, including the Visual Activities Questionnaire, Sickness Impact Profile, and a Symptom and Health Problem CHECKLIST: The correlations between QOL measures and clinical outcomes were in the expected direction, but relatively weak. At initial diagnosis, difficulty with bright lights and with light and dark adaptation were the most frequently reported symptoms related to visual function, whereas visual distortion was the most bothersome. Approximately half of the patients reported at least some worry or concern about the possibility of blindness. Within the Visual Activities Questionnaire, higher scores on the Peripheral Vision subscale were associated with more field loss (P < 0.01). In regression analyses controlling for sociodemographics and nonocular comorbidities, increased visual field loss was significantly associated with higher dysfunction among five disease-specific QOL measures (P < 0.05). Newly diagnosed glaucoma patients reported experiencing some visual function symptoms at the time of diagnosis that would not be intuitively expected based on clinical testing. Some discussion about the association between clinical presentation and worry about blindness may reduce unnecessary concern. These results provide the basis for long-term comparisons of the QOL effects of initial medical and surgical treatment for open-angle glaucoma.

Conjugated Equine Estrogens and Breast Cancer Risk in the Women’s Health Initiative Clinical Trial and Observational Study

PubMed Central

Prentice, Ross L.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Manson, JoAnn E.; Langer, Robert D.; Pettinger, Mary; Hendrix, Susan L.; Hubbell, F. Allan; Kooperberg, Charles; Kuller, Lewis H.; Lane, Dorothy S.; McTiernan, Anne; O’Sullivan, Mary Jo; Rossouw, Jacques E.; Anderson, Garnet L.

2009-01-01

The Women’s Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogenalone preparations. In 1993–2004 at 40 US clinical centers, breast cancer hazard ratio estimates for this CEE regimen were compared between the Women’s Health Initiative clinical trial and observational study toward understanding this apparent discrepancy and refining hazard ratio estimates. After control for prior use of postmenopausal hormone therapy and for confounding factors, CEE hazard ratio estimates were higher from the observational study compared with the clinical trial by 43% (p = 0.12). However, after additional control for time from menopause to first use of postmenopausal hormone therapy, the hazard ratios agreed closely between the two cohorts (p = 0.82). For women who begin use soon after menopause, combined analyses of clinical trial and observational study data do not provide clear evidence of either an overall reduction or an increase in breast cancer risk with CEEs, although hazard ratios appeared to be relatively higher among women having certain breast cancer risk factors or a low body mass index. PMID:18448442

Comparative effectiveness of generic versus brand-name antiepileptic medications.

PubMed

Gagne, Joshua J; Kesselheim, Aaron S; Choudhry, Niteesh K; Polinski, Jennifer M; Hutchins, David; Matlin, Olga S; Brennan, Troyen A; Avorn, Jerry; Shrank, William H

2015-11-01

The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical initiatives linking Japanese and Swedish healthcare resources on cancer studies utilizing Biobank Repositories.

PubMed

Nishimura, Toshihide; Kawamura, Takeshi; Sugihara, Yutaka; Bando, Yasuhiko; Sakamoto, Shigeru; Nomura, Masaharu; Ikeda, Norihiko; Ohira, Tatsuo; Fujimoto, Junichiro; Tojo, Hiromasa; Hamakubo, Takao; Kodama, Tatsuhiko; Andersson, Roland; Fehniger, Thomas E; Kato, Harubumi; Marko-Varga, György

2014-12-01

The Tokyo Medical University Hospital in Japan and the Lund University hospital in Sweden have recently initiated a research program with the objective to impact on patient treatment by clinical disease stage characterization (phenotyping), utilizing proteomics sequencing platforms. By sharing clinical experiences, patient treatment principles, and biobank strategies, our respective clinical teams in Japan and Sweden will aid in the development of predictive and drug related protein biomarkers. Data from joint lung cancer studies are presented where protein expression from Neuro- Endocrine lung cancer (LCNEC) phenotype patients can be separated from Small cell- (SCLC) and Large Cell lung cancer (LCC) patients by deep sequencing and spectral counting analysis. LCNEC, a subtype of large cell carcinoma (LCC), is characterized by neuroendocrine differentiation that small cell lung carcinoma (SCLC) shares. Pre-therapeutic histological distinction between LCNEC and SCLC has so far been problematic, leading to adverse clinical outcome. An establishment of protein targets characteristic of LCNEC is quite helpful for decision of optimal therapeutic strategy by diagnosing individual patients. Proteoform annotation and clinical biobanking is part of the HUPO initiative (http://www.hupo.org) within chromosome 10 and chromosome 19 consortia.

Clinical pathways for acute coronary syndromes in China: protocol for a hospital quality improvement initiative.

PubMed

Rong, Ye; Turnbull, Fiona; Patel, Anushka; Du, Xin; Wu, Yangfeng; Gao, Runlin

2010-09-01

Clinical pathways have been shown to be effective in improving quality of care for patients admitted to hospital for acute coronary syndromes (ACS) in high-income countries. However, their utility has not formally been evaluated in low- or middle-income countries. The Clinical Pathways for Acute Coronary Syndromes in China program is a 7-year study with the overall goal of reducing evidence-practice gaps in the management of patients admitted to hospitals in China with suspected ACS. The program comprises 2 phases: a prospective survey of current management of ACS patients to identify the areas that evidence-based patient care can be potentially improved, and a quality care initiative to maximize the use of evidence-based investigations and treatments for ACS patients in China. In this article, we outline the details of the study protocol, including key aspects of the development, implementation, and evaluation of the quality improvement initiative (clinical pathway) for management of patients with suspected ACS.

A decade of the Clinical Trials Transformation Initiative: What have we accomplished? What have we learned?

PubMed

Tenaerts, P; Madre, L; Landray, M

2018-02-01

The Clinical Trials Transformation Initiative reflects on 10 years of working to improve the quality and efficiency of clinical trials. This article highlights many of the Clinical Trials Transformation Initiative's accomplishments and offers examples of the impact that the Clinical Trials Transformation Initiative has had on the clinical trials enterprise. After conducting more than 25 projects and issuing recommendations for specific strategies to improve the design and execution of clinical trials, some common themes and lessons learned have emerged. Lessons include the importance of engaging many stakeholders, advanced planning to address critical issues, discontinuation of non-value added practices, and new opportunities presented by technology. Through its work, the Clinical Trials Transformation Initiative has also derived some operational best practices for conducting collaborative, multi-stakeholder projects covering project selection, project team dynamics and execution, and multi-stakeholder meetings and team discussions. Through these initiatives, the Clinical Trials Transformation Initiative has helped move the needle toward needed change in the clinical trials enterprise that has directly impacted stakeholders and patients alike.

The California Clinical Data Project: a case study in the adoption of clinical data standards for quality improvement.

PubMed

Sujansky, Walter; Chang, Sophia

2006-01-01

The California Clinical Data Project is a statewide initiative to remove barriers to the widespread and effective use of information technology to improve chronic disease care. The project is a case study in the development and widespread adoption of clinical data standards by varied and often competing stakeholders. As an initial step, the project defined precise data standards for the batch reporting of pharmacy claims data and laboratory results data. These uniform standards facilitate the flow of existing electronic clinical information into disease registries and electronic health record systems. Pharmacy and lab results data now are being exchanged electronically with this standard among the largest health plans, medical groups, and clinical laboratories participating in California's pay-for-performance programs. Lessons from this project may apply to the development and adoption of data standards for other states and locales and for the emerging national health information infrastructure.

Asthma in pregnancy: association between the Asthma Control Test and the Global Initiative for Asthma classification and comparisons with spirometry.

PubMed

de Araujo, Georgia Véras; Leite, Débora F B; Rizzo, José A; Sarinho, Emanuel S C

2016-08-01

The aim of this study was to identify a possible association between the assessment of clinical asthma control using the Asthma Control Test (ACT) and the Global Initiative for Asthma (GINA) classification and to perform comparisons with values of spirometry. Through this cross-sectional study, 103 pregnant women with asthma were assessed in the period from October 2010 to October 2013 in the asthma pregnancy clinic at the Clinical Hospital of the Federal University of Pernambuco. Questionnaires concerning the level of asthma control were administered using the Global Initiative for Asthma classification, the Asthma Control Test validated for asthmatic expectant mothers and spirometry; all three methods of assessing asthma control were performed during the same visit between the twenty-first and twenty-seventh weeks of pregnancy. There was a significant association between clinical asthma control assessment using the Asthma Control Test and the Global Initiative for Asthma classification (p<0.001). There were also significant associations between the results of the subjective instruments of asthma (the GINA classification and the ACT) and evidence of lung function by spirometry. This study shows that both the Global Initiative for Asthma classification and the Asthma Control Test can be used for asthmatic expectant mothers to assess the clinical control of asthma, especially at the end of the second trimester, which is assumed to be the period of worsening asthma exacerbations during pregnancy. We highlight the importance of the Asthma Control Test as a subjective instrument with easy application, easy interpretation and good reproducibility that does not require spirometry to assess the level of asthma control and can be used in the primary care of asthmatic expectant mothers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Do Patients and Oncologists Discuss the Cost of Cancer Treatment? An Observational Study of Clinical Interactions Between African American Patients and Their Oncologists.

PubMed

Hamel, Lauren M; Penner, Louis A; Eggly, Susan; Chapman, Robert; Klamerus, Justin F; Simon, Michael S; Stanton, Sarah C E; Albrecht, Terrance L

2017-03-01

Financial toxicity negatively affects patients with cancer, especially racial/ethnic minorities. Patient-oncologist discussions about treatment-related costs may reduce financial toxicity by factoring costs into treatment decisions. This study investigated the frequency and nature of cost discussions during clinical interactions between African American patients and oncologists and examined whether cost discussions were affected by patient sociodemographic characteristics and social support, a known buffer to perceived financial stress. Methods Video recorded patient-oncologist clinical interactions (n = 103) from outpatient clinics of two urban cancer hospitals (including a National Cancer Institute-designated comprehensive cancer center) were analyzed. Coders studied the videos for the presence and duration of cost discussions and then determined the initiator, topic, oncologist response to the patient's concerns, and the patient's reaction to the oncologist's response. Cost discussions occurred in 45% of clinical interactions. Patients initiated 63% of discussions; oncologists initiated 36%. The most frequent topics were concern about time off from work for treatment (initiated by patients) and insurance (initiated by oncologists). Younger patients and patients with more perceived social support satisfaction were more likely to discuss cost. Patient age interacted with amount of social support to affect frequency of cost discussions within interactions. Younger patients with more social support had more cost discussions; older patients with more social support had fewer cost discussions. Cost discussions occurred in fewer than one half of the interactions and most commonly focused on the impact of the diagnosis on patients' opportunity costs rather than treatment costs. Implications for ASCO's Value Framework and design of interventions to improve cost discussions are discussed.

Application of Viscoelastic Fracture Model and Non-uniform Crack Initiation at Clinically Relevant Notches in Crosslinked UHMWPE

PubMed Central

Sirimamilla, P. Abhiram; Furmanski, Jevan; Rimnac, Clare M.

2012-01-01

The mechanism of crack initiation from a clinically relevant notch is not well-understood for crosslinked ultra high molecular weight polyethylene (UHMWPE) used in total joint replacement components. Static mode driving forces, rather than the cyclic mode conditions typically associated with fatigue processes, have been shown to drive crack propagation in this material. Thus, in this study, crack initiation in a notched specimen under a static load was investigated. A video microscope was used to monitor the notch surface of the specimen and crack initiation time was measured from the video by identifying the onset of crack initiation at the notch. Crack initiation was considered using a viscoelastic fracture theory. It was found that the mechanism of crack initiation involved both single layer and a distributed multi-layer phenomenon and that multi-layer crack initiation delayed the crack initiation time for all loading conditions examined. The findings of this study support that the viscoelastic fracture theory governs fracture mechanics in crosslinked UHMWPE. The findings also support that crack initiation from a notch in UHMWPE is a more complex phenomenon than treated by traditional fracture theories for polymers. PMID:23127638

Long term continuous positive airway pressure (CPAP) and noninvasive ventilation (NIV) in children: Initiation criteria in real life.

PubMed

Amaddeo, A; Moreau, J; Frapin, A; Khirani, S; Felix, O; Fernandez-Bolanos, M; Ramirez, A; Fauroux, B

2016-09-01

Long term noninvasive continuous positive airway pressure (CPAP) and noninvasive ventilation (NIV) are increasingly used in children but limited information is available on the criteria and conditions leading to the initiation of these treatments. The aim of the study is to describe the objective overnight respiratory parameters and clinical situations that led to the initiation of CPAP/NIV in a pediatric NIV unit. Retrospective analysis of the data of all the children discharged on home CPAP/NIV over a 1 year period. Seventy-six patients were started on CPAP (n = 64) or NIV (n = 12). CPAP/NIV was initiated because of CPAP/NIV weaning failure (Acute group) in 15 patients. None of these patients had an overnight gas exchange or sleep study before CPAP/NIV initiation. In 18 patients, CPAP/NIV was initiated on abnormal nocturnal gas exchange alone (Subacute group). These patients had a median of three of the following five overnight gas exchange abnormalities: minimal pulse oximetry (SpO2 ) <90%, maximal transcutaneous carbon dioxide (PtcCO2 ) >50 mmHg, time spent with SpO2 <90% or PtcCO2 >50 mmHg ≥2% of recording time, oxygen desaturation index >1.4/hr. In the last 43 patients, CPAP/NIV was initiated after an abnormal sleep study (Chronic group) on a mean of four of the aforementioned criteria and an apnea-hypopnea index >10/hr. In clinical practice, CPAP/NIV was initiated in an acute, subacute and chronic setting with most patients having an association of several abnormal gas exchange or sleep study parameters. Future studies should evaluate the effectiveness and benefits of CPAP/NIV according to the clinical situation and initiation criteria. Pediatr Pulmonol. 2016; 51:968-974. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Repeat Chlamydia trachomatis testing among heterosexual STI outpatient clinic visitors in the Netherlands: a longitudinal study.

PubMed

Visser, Maartje; van Aar, Fleur; Koedijk, Femke D H; Kampman, Carolina J G; Heijne, Janneke C M

2017-12-20

Chlamydia infections are common in both men and women, are often asymptomatic and can cause serious complications. Repeat testing in high-risk groups is therefore indicated. In the Netherlands, guidelines on repeat chlamydia testing differ between testing facilities, and knowledge on repeat testing behaviour is limited. Here, we analyse the current repeat testing behaviour of heterosexual STI clinic visitors, and aim to identify groups for which repeat testing advice could be advantageous. Longitudinal surveillance data from all Dutch STI outpatient clinics were used, which included all STI clinic consultations carried out among heterosexual men and women between June 2014 and December 2015. Repeat testing was defined as returning to the same STI clinic between 35 days and 12 months after initial consultation. We calculated chlamydia positivity at repeat test stratified by initial test result and time between consultations. Logistic regression analyses were used to identify predictors of repeat testing, and predictors of having a chlamydia positive repeat test. In total, 140,486 consultations in 75,487 women and 46,286 men were available for analyses. Overall, 15.4% of women and 11.1% of men returned to the STI clinic within the study period. Highest chlamydia positivity at repeat test was seen 3-5 months after initial positive test. Among both women and men, repeat testing was associated with non-Western ethnicity, having had more than two sex partners in the past 6 months, reporting STI symptoms, having a history of STI, and having a chlamydia positive initial test. Among repeat testers, chlamydia positive repeat test was most strongly associated with younger age, followed by a chlamydia positive initial test. Repeat testing most often resulted in a positive test result among young heterosexuals (<25) and heterosexuals of any age with a chlamydia infection at the initial consultation. Further efforts are needed to determine optimal repeat testing strategies.

Cognitive Behavioral Treatment of Panic Disorder and Agoraphobia in a Multiethnic Urban Outpatient Clinic: Initial Presentation and Treatment Outcome

ERIC Educational Resources Information Center

Friedman, Steven; Braunstein, Jeffrey W.; Halpern, Beth

2006-01-01

Few studies examine the effectiveness of panic control treatment across diverse ethnic groups. In this paper we present data on 40 patients (African American, n = 24; Caucasian, n = 16) with panic disorder and comorbid agoraphobia who presented at an anxiety disorder clinic in an inner-city area. On initial assessment both groups were similar on…

Centralized Research Recruitment—Evolving a Local Clinical Research Recruitment Web Application to Better Meet User Needs

PubMed Central

Dwyer‐White, Molly; Doshi, Aalap; Hill, Mary; Pienta, Kenneth J.

2011-01-01

Abstract  Recruiting volunteers into clinical research remains a significant challenge for many clinical research study teams, thus the Michigan Institute for Clinical and Health Research (MICHR) at the University of Michigan developed UMClinicalStudies (http://www.UMClinicalStudies.org)—a Web application that links the community to a single gateway for clinical research. UMClinicalStudies (formerly named “Engage”) is an integral piece of MICHR’s efforts to increase clinical research participation in order to advance medical discoveries. Despite the initial success of the application, barriers to research participation remain, including the applications accessibility for potential research volunteers and study team members. In response, new initiatives were instigated to identify user needs, in order to broaden the ability to simultaneously assist researchers in recruitment activities, while also aiding potential volunteers in the exploration of and participation in clinical research opportunities. To do this, improvements to the interface and functionality were identified and implemented for both the public and the research audiences through extensive system analysis, and through the application of human computer interactivity processes, resulting in significant improvements in usability and ultimately research volunteerism, indicating that utilizing such technology is pivotal in reaching broader audiences for clinical trial participation. Clin Trans Sci 2011; Volume 4: 363–368 PMID:22029810

The Alzheimer's Prevention Initiative Generation Program: Evaluating CNP520 Efficacy in the Prevention of Alzheimer's Disease.

PubMed

Lopez Lopez, C; Caputo, A; Liu, F; Riviere, M E; Rouzade-Dominguez, M-L; Thomas, R G; Langbaum, J B; Lenz, R; Reiman, E M; Graf, A; Tariot, P N

2017-01-01

Alzheimer's disease pathology begins decades before the onset of clinical symptoms. This provides an opportunity for interventional clinical trials to potentially delay or prevent the onset of cognitive impairment or dementia. CNP520 (a beta-site-amyloid precursor protein-cleaving enzyme inhibitor) is in clinical development for the treatment of preclinical Alzheimer's disease under the Alzheimer's Prevention Initiative Generation Program. The Alzheimer's Prevention Initiative is a public-private partnership intended to accelerate the evaluation of Alzheimer's disease prevention therapies. The Generation Program comprises two pivotal phase II/III studies with similar designs to assess the efficacy and safety of investigational treatments in a cognitively unimpaired population at increased risk for developing Alzheimer's disease based on age and apolipoprotein E (APOE) genotype (i.e., presence of the APOE ε4 allele). The program has been designed to maximize benefit to Alzheimer's disease research. Generation Study 1 (NCT02565511) and Generation Study 2 (NCT03131453) are currently enrolling; their key features are presented here.

A Review of Smoking Research In Malaysia.

PubMed

Wee, L H; Chan, C M H; Yogarabindranath, S N

2016-06-01

Two hundred and seventy one original published materials related to tobacco use were found in a search through a database dedicated to indexing all original data relevant to Medicine and Health in Malaysia from 1996 - 2015. A total of 147 papers were selected and reviewed on the basis of their relevance and implications for future research. Findings were summarised, categorised and presented according to epidemiology, behaviour, clinical features and management of smoking. Most studies are cross-sectional with small sample sizes. Studies on smoking initiation and prevalence showed mixed findings with many small scale studies within the sub-groups. The majority of the studies were related to factors that contribute to initiation in adolescents. Nonetheless, there are limited studies on intervention strategies to curb smoking among this group. There is a lack of clinical studies to analyse tobacco use and major health problems in Malaysia. In addition, studies on the best treatment modalities on the use of pharmacotherapy and behavioural counselling have also remained unexplored. Reasons why smokers do not seek clinic help to quit smoking need further exploration. A finding on the extent of effort carried out by healthcare providers in assisting smokers to make quit attempts is not known. Studies on economic and government initiatives on policies and tobacco use focus mainly on the effects of cigarette bans, increased cigarettes taxes and the influence of the tobacco industry. Recommendations are given for the government to increase efforts in implementing smoke-free legislation, early and tailored interventions. Clinical studies in this area are lacking, as are opportunities to research on ways to reduce smoking initiation age and the most effective quit smoking strategies.

The role of autologous hematopoietic progenitor and cell reinfusion for intensive chemotherapy in women with poor-prognosis breast cancer. Clinical studies with ex-vivo expanded cells produced with the Aastrom Replicell technology.

PubMed

Chabannon, C; Novakovitch, G; Blache, J L; Olivero, S; Camerlo, J; Genre, D; Maraninchi, D; Viens, P

1999-04-01

In recent years, we have initiated two clinical studies, to evaluate the usefulness of ex-vivo expanded cells in patients with breast cancer who receive sequential high-dose chemotherapy. Ex-vivo expanded cells were produced from autologous cryopreserved bone marrow nucleated cells, using a biomedical device. The Aastrom Replicell system cultures cells in animal serum-replete medium, with a combination of flt3-L, PIXY321 and Epo, for 12 days. The initial pilot trial was set up to establish the feasibility and safety of the technique: 6 patients completed the study. An ongoing randomized study searches to establish whether ex-vivo expanded cells provide a clinical benefit.

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag.

PubMed

Kogure, Seiji; Koyama, Nobuyuki; Hidaka, Shinji

2017-11-01

Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies. © 2017, The American College of Clinical Pharmacology.

One thing leads to another: the cascade of obligations when researchers report genetic research results to study participants.

PubMed

Miller, Fiona Alice; Hayeems, Robin Zoe; Li, Li; Bytautas, Jessica Peace

2012-08-01

Even as debate continues about the putative obligation to proactively report genetic research results to study participants, there is an increasing need to attend to the obligations that might cascade from any initial report. We conducted an international, quasi-experimental survey of researchers involved in autism spectrum disorders (ASD) and cystic fibrosis (CF) genetics to explore perceived obligations to ensure updated information or relevant clinical care subsequent to any initial communication of research results, and factors influencing these attitudes. 5-point Likert scales of dis/agreement were analyzed using descriptive and multivariate statistics. Of the 343 respondents (44% response rate), large majorities agreed that in general and in a variety of hypothetical research contexts, research teams that report results should ensure that participants gain subsequent access to updated information (74-83%) and implicated clinical services (79-87%). At the same time, researchers perceived barriers restricting access to relevant clinical care, though this was significantly more pronounced (P<0.001) for ASD (64%) than CF (34%). In the multivariate model, endorsement of cascading obligations was positively associated with researcher characteristics (eg, clinical role/training) and attitudes (eg, perceived initial reporting obligation), and negatively associated with the initial report of less scientifically robust hypothetical results, but unaffected by perceived or hypothetical barriers to care. These results suggest that researchers strongly endorse information and care-based obligations that cascade from the initial report of research results to study participants. In addition, they raise challenging questions about how any cascading obligations are to be met, especially where access challenges are already prevalent.

Impact of the moon on cerebral aneurysm rupture.

PubMed

Kamp, Marcel A; Dibué, Maxine; Slotty, Philipp; Steiger, Hans-Jakob; Hänggi, Daniel

2013-08-01

Several external and internal risk factors for cerebral aneurysm rupture have been identified to date. Recently, it has been reported that moon phases correlate with the incidence of aneurysmal subarachnoid hemorrhage (SAH), however, another author found no such association. Therefore, the present study investigates the influence of the lunar cycle on the incidence of aneurysmal rupture, the initial clinical presentation, and the amount of subarachnoid blood. Lunar phase and the particular day of the lunar cycle were correlated to the date of aneurysm rupture, aneurysm location, initial clinical presentation, and amount of subarachnoid blood assessed from CT scans of all patients treated for basal SAH in our department from 2003 to 2010. We found no correlation between incidence of aneurysmal SAH, location of the aneurysm, initial clinical presentation, or amount of subarachnoid blood and the lunar cycle. The moon influences neither the incidence of aneurysmal SAH nor the grade of initial neurological deterioration or amount of subarachnoid blood.

Incident pregnancy and time to death or AIDS among HIV-positive women receiving antiretroviral therapy.

PubMed

Westreich, Daniel; Maskew, Mhairi; Evans, Denise; Firnhaber, Cindy; Majuba, Pappie; Sanne, Ian

2013-01-01

Little is known about the impact of pregnancy on response to highly active antiretroviral therapy (HAART) in sub-Saharan Africa. We examined the effect of incident pregnancy after HAART initiation on clinical response to HAART. We evaluated a prospective clinical cohort of adult women initiating HAART in Johannesburg, South Africa between 1 April 2004 and 31 March 2011, and followed up until an event, transfer, drop-out, or administrative end of follow-up on 30 September 2011. Women over age 45 and women who were pregnant at HAART initiation were excluded from the study. Main exposure was having experienced pregnancy after HAART initiation; main outcome was death and (separately) death or new AIDS event. We calculated adjusted hazard ratios (HRs) and 95% confidence limits (CL) using marginal structural Cox proportional hazards models. The study included 7,534 women, and 20,813 person-years of follow-up; 918 women had at least one recognized pregnancy during follow-up. For death alone, the weighted (adjusted) HR was 0.84 (95% CL 0.44, 1.60). Sensitivity analyses confirmed main results, and results were similar for analysis of death or new AIDS event. Incident pregnancy was associated with a substantially reduced hazard of drop-out (HR = 0.62, 95% CL 0.51, 0.75). Recognized incident pregnancy after HAART initiation was not associated with increases in hazard of clinical events, but was associated with a decreased hazard of drop-out. High rates of pregnancy after initiation of HAART may point to a need to better integrate family planning services into clinical care for HIV-infected women.

Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

PubMed

Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

2016-01-01

Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline release without active dissemination. We hypothesize that the clinics randomized to the intervention group will have a lower proportion of early dialysis starts. Limitations include passive dissemination of the guideline through publication, and lead-time and survivor bias, which favors delayed dialysis initiation. If successful, this active knowledge translation intervention will reduce early dialysis starts, lead to health and economic benefits, and provide a successful framework for evaluating and disseminating future guidelines. ClinicalTrials.gov, NCT02183987.

Biomarkers from distinct biological pathways improve early risk stratification in medical emergency patients: the multinational, prospective, observational TRIAGE study.

PubMed

Schuetz, Philipp; Hausfater, Pierre; Amin, Devendra; Amin, Adina; Haubitz, Sebastian; Faessler, Lukas; Kutz, Alexander; Conca, Antoinette; Reutlinger, Barbara; Canavaggio, Pauline; Sauvin, Gabrielle; Bernard, Maguy; Huber, Andreas; Mueller, Beat

2015-10-29

Early risk stratification in the emergency department (ED) is vital to reduce time to effective treatment in high-risk patients and to improve patient flow. Yet, there is a lack of investigations evaluating the incremental usefulness of multiple biomarkers measured upon admission from distinct biological pathways for predicting fatal outcome and high initial treatment urgency in unselected ED patients in a multicenter and multinational setting. We included consecutive, adult, medical patients seeking ED care into this observational, cohort study in Switzerland, France and the USA. We recorded initial clinical parameters and batch-measured prognostic biomarkers of inflammation (pro-adrenomedullin [ProADM]), stress (copeptin) and infection (procalcitonin). During a 30-day follow-up, 331 of 7132 (4.6 %) participants reached the primary endpoint of death within 30 days. In logistic regression models adjusted for conventional risk factors available at ED admission, all three biomarkers strongly predicted the risk of death (AUC 0.83, 0.78 and 0.75), ICU admission (AUC 0.67, 0.69 and 0.62) and high initial triage priority (0.67, 0.66 and 0.58). For the prediction of death, ProADM significantly improved regression models including (a) clinical information available at ED admission (AUC increase from 0.79 to 0.84), (b) full clinical information at ED discharge (AUC increase from 0.85 to 0.88), and (c) triage information (AUC increase from 0.67 to 0.83) (p <0.01 for each comparison). Similarly, ProADM also improved clinical models for prediction of ICU admission and high initial treatment urgency. Results were robust in regard to predefined patient subgroups by center, main diagnosis, presenting symptoms, age and gender. Combination of clinical information with results of blood biomarkers measured upon ED admission allows early and more adequate risk stratification in individual unselected medical ED patients. A randomized trial is needed to answer the question whether biomarker-guided initial patient triage reduces time to initial treatment of high-risk patients in the ED and thereby improves patient flow and clinical outcomes. ClinicalTrials.gov NCT01768494 . Registered January 9, 2013.

The value of formal clinical research training in initiating a career as a clinical investigator.

PubMed

Kapoor, Karan; Wu, Bechien U; Banks, Peter A

2011-12-01

The aim of this study was to determine whether formal clinical research training is of value in the initiation of a successful career as a clinical investigator. We conducted a retrospective review of the career choices of all 25 fellows who entered the Academic Clinical Research Track at Brigham and Women's Hospital since its inception in 1995 and examined the impact of formal clinical research training during their fellowship on their career choice. The primary measure of a successful career as a clinical investigator was the obtainment of external funding for clinical research within 3 years of completion of fellowship. Thirteen of the 25 fellows (52%) received a Master of Public Health (MPH) degree at the Harvard School of Public Health during their fellowship. Ten of these 13 fellows (77%) obtained external funding for clinical research within 3 years of completion of their fellowship. None of the 5 fellows who had already obtained an MPH degree prior to their fellowship and none of the 7 fellows who completed a 7-week summer Program in Clinical Effectiveness but did not complete an MPH degree attempted to receive external funding for clinical research within 3 years of completion of their fellowship. We conclude that formal clinical research training culminating in an MPH degree was extremely valuable in the initiation of a successful career as a clinical investigator.

NIH Study Offers Insight into Why Cancer Incidence Increases with Age

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

NIH Study Finds Regular Aspirin Use May Reduce Ovarian Cancer Risk

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Initial Readability Assessment of Clinical Trial Eligibility Criteria

PubMed Central

Kang, Tian; Elhadad, Noémie; Weng, Chunhua

2015-01-01

Various search engines are available to clinical trial seekers. However, it remains unknown how comprehensible clinical trial eligibility criteria used for recruitment are to a lay audience. This study initially investigated this problem. Readability of eligibility criteria was assessed according to (i) shallow and lexical characteristics through the use of an established, generic readability metric; (ii) syntactic characteristics through natural language processing techniques; and (iii) health terminological characteristics through an automated comparison to technical and lay health texts. We further stratified clinical trials according to various study characteristics (e.g., source country or study type) to understand potential factors influencing readability. Mainly caused by frequent use of technical jargons, a college reading level was found to be necessary to understand eligibility criteria text, a level much higher than the average literacy level of the general American population. The use of technical jargons should be minimized to simplify eligibility criteria text. PMID:26958204

Barriers to investigator-initiated deep brain stimulation and device research

PubMed Central

Malone, Donald; Okun, Michael S.; Booth, Joan; Machado, Andre G.

2014-01-01

The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. However, both the structure of clinical trial funding and the current regulation of device research threaten investigator-initiated efforts in neurologic disorders. The current atmosphere dissuades clinical investigators from pursuing formal and prospective research with novel devices or novel indications. We review our experience in conducting a federally funded, investigator-initiated, device-based clinical trial that utilized DBS for thalamic pain syndrome. We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients. PMID:24670888

Implementation of a quality improvement initiative in Belgian diabetic foot clinics: feasibility and initial results.

PubMed

Doggen, Kris; Van Acker, Kristien; Beele, Hilde; Dumont, Isabelle; Félix, Patricia; Lauwers, Patrick; Lavens, Astrid; Matricali, Giovanni A; Randon, Caren; Weber, Eric; Van Casteren, Viviane; Nobels, Frank

2014-07-01

This article aims to describe the implementation and initial results of an audit-feedback quality improvement initiative in Belgian diabetic foot clinics. Using self-developed software and questionnaires, diabetic foot clinics collected data in 2005, 2008 and 2011, covering characteristics, history and ulcer severity, management and outcome of the first 52 patients presenting with a Wagner grade ≥ 2 diabetic foot ulcer or acute neuropathic osteoarthropathy that year. Quality improvement was encouraged by meetings and by anonymous benchmarking of diabetic foot clinics. The first audit-feedback cycle was a pilot study. Subsequent audits, with a modified methodology, had increasing rates of participation and data completeness. Over 85% of diabetic foot clinics participated and 3372 unique patients were sampled between 2005 and 2011 (3312 with a diabetic foot ulcer and 111 with acute neuropathic osteoarthropathy). Median age was 70 years, median diabetes duration was 14 years and 64% were men. Of all diabetic foot ulcers, 51% were plantar and 29% were both ischaemic and deeply infected. Ulcer healing rate at 6 months significantly increased from 49% to 54% between 2008 and 2011. Management of diabetic foot ulcers varied between diabetic foot clinics: 88% of plantar mid-foot ulcers were off-loaded (P10-P90: 64-100%), and 42% of ischaemic limbs were revascularized (P10-P90: 22-69%) in 2011. A unique, nationwide quality improvement initiative was established among diabetic foot clinics, covering ulcer healing, lower limb amputation and many other aspects of diabetic foot care. Data completeness increased, thanks in part to questionnaire revision. Benchmarking remains challenging, given the many possible indicators and limited sample size. The optimized questionnaire allows future quality of care monitoring in diabetic foot clinics. Copyright © 2014 John Wiley & Sons, Ltd.

Sociodemographic profile and predictors of outpatient clinic attendance among HIV-positive patients initiating antiretroviral therapy in Selangor, Malaysia.

PubMed

Abdulrahman, Surajudeen Abiola; Rampal, Lekhraj; Othman, Norlijah; Ibrahim, Faisal; Hayati, Kadir Shahar; Radhakrishnan, Anuradha P

2017-01-01

Inconsistent literature evidence suggests that sociodemographic, economic, and system- and patient-related factors are associated with clinic attendance among the HIV-positive population receiving antiretroviral therapy (ART) around the world. We examined the factors that predict outpatient clinic attendance among a cohort of HIV-positive patients initiating ART in Selangor, Malaysia. This cross-sectional study analyzed secondary data on outpatient clinic attendance and sociodemographic, economic, psychosocial, and patient-related factors among 242 adult Malaysian patients initiating ART in Selangor, Malaysia. Study cohort was enrolled in a parent randomized controlled trial (RCT) in Hospital Sungai Buloh Malaysia between January and December 2014, during which peer counseling, medication, and clinic appointment reminders were provided to the intervention group through short message service (SMS) and telephone calls for 24 consecutive weeks. Data on outpatient clinic attendance were extracted from the hospital electronic medical records system, while other patient-level data were extracted from pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires in which primary data were collected. Outpatient clinic attendance was categorized into binary outcome - regular attendee and defaulter categories - based on the number of missed scheduled outpatient clinic appointments within a 6-month period. Multivariate regression models were fitted to examine predictors of outpatient clinic attendance using SPSS version 22 and R software. A total of 224 (93%) patients who completed 6-month assessment were included in the model. Out of those, 42 (18.7%) defaulted scheduled clinic attendance at least once. Missed appointments were significantly more prevalent among females (n=10, 37.0%), rural residents (n=10, 38.5%), and bisexual respondents (n=8, 47.1%). Multivariate binary logistic regression analysis showed that Indian ethnicity (adjusted odds ratio [AOR] =0.235; 95% CI [0.063-0.869]; P =0.030) and heterosexual orientation (AOR =4.199; 95% CI [1.040-16.957]; P =0.044) were significant predictors of outpatient clinic attendance among HIV-positive patients receiving ART in Malaysia. Ethnicity and sexual orientation of Malaysian patients may play a significant role in their level of adherence to scheduled clinic appointments. These factors should be considered during collaborative adherence strategy planning at ART initiation.

Clinical and radiographic assessment of various predictors for healing outcome 1 year after periapical surgery.

PubMed

von Arx, Thomas; Jensen, Simon Storgård; Hänni, Stefan

2007-02-01

This clinical study prospectively evaluated the influence of various predictors on healing outcome 1 year after periapical surgery. The study cohort included 194 teeth in an equal number of patients. Three teeth were lost for the follow-up (1.5% drop-out rate). Clinical and radiographic measures were used to determine the healing outcome. For statistical analysis, results were dichotomized (healed versus nonhealed). The overall success rate was 83.8% (healed cases). The only individual predictors to prove significant for the outcome were pain at initial examination (p=0.030) and other clinical signs or symptoms at initial examination (p=0.042), meaning that such teeth had lower healing rates 1 year after periapical surgery compared with teeth without such signs or symptoms. Logistic regression revealed that pain at initial examination (odds ratio=2.59, confidence interval=1.2-5.6, p=0.04) was the only predictor reaching significance. Several predictors almost reached statistical significance: lesion size (p=0.06), retrofilling material (p=0.06), and postoperative healing course (p=0.06).

Treatment outcomes of HIV-positive patients on first-line antiretroviral therapy in private versus public HIV clinics in Johannesburg, South Africa.

PubMed

Moyo, Faith; Chasela, Charles; Brennan, Alana T; Ebrahim, Osman; Sanne, Ian M; Long, Lawrence; Evans, Denise

2016-01-01

Despite the widely documented success of antiretroviral therapy (ART), stakeholders continue to face the challenges of poor HIV treatment outcomes. While many studies have investigated patient-level causes of poor treatment outcomes, data on the effect of health systems on ART outcomes are scarce. We compare treatment outcomes among patients receiving HIV care and treatment at a public and private HIV clinic in Johannesburg, South Africa. This was a retrospective cohort analysis of ART naïve adults (≥18.0 years), initiating ART at a public or private clinic in Johannesburg between July 01, 2007 and December 31, 2012. Cox proportional-hazards regression was used to identify baseline predictors of mortality and loss to follow-up (>3 months late for the last scheduled visit). Generalized estimating equations were used to determine predictors of failure to suppress viral load (≥400 copies/mL) while the Wilcoxon rank-sum test was used to compare the median absolute change in CD4 count from baseline to 12 months post-ART initiation. 12,865 patients initiated ART at the public clinic compared to 610 at the private clinic. The patients were similar in terms of sex and age at initiation. Compared to public clinic patients, private clinic patients initiated ART at higher median CD4 counts (159 vs 113 cells/mm(3)) and World Health Organization stage I/II (76.1% vs 58.5%). Adjusted hazard models showed that compared to public clinic patients, private clinic patients were less likely to die (adjusted hazard ratio [aHR] 0.50; 95% confidence interval [CI] 0.35-0.70) but were at increased risk of loss to follow-up (aHR 1.80; 95% CI 1.59-2.03). By 12 months post-ART initiation, private clinic patients were less likely to have a detectable viral load (adjusted relative risk 0.65; 95% CI 0.49-0.88) and recorded higher median CD4 change from baseline (184 cells/mm(3) interquartile range 101-300 vs 158 cells/mm(3) interquartile range 91-244), when compared to public clinic patients. We identified differences in treatment outcomes between the two HIV clinics. Findings suggest that the type of clinic at which ART patients initiate and receive treatment can have an impact on treatment outcomes. Further research is necessary to provide more conclusive results.

5 CFR 5502.107 - Supplemental disclosure of financial interests in substantially affected organizations applicable...

Code of Federal Regulations, 2010 CFR

2010-01-01

... clinical study involving human subjects under a clinical research protocol approved by an institutional review board. (2) Clinical research has the meaning set forth in 42 U.S.C. 284d(b). (3) Institutional... review a clinical research protocol and approve the initiation of biomedical research involving human...

Is a high initial World Federation of Neurosurgery (WFNS) grade really associated with a poor clinical outcome in elderly patients with ruptured intracranial aneurysms treated with coiling?

PubMed

Iosif, Christina; Di Maria, Federico; Sourour, Nader; Degos, Vincent; Bonneville, Fabrice; Biondi, Alessandra; Jean, Betty; Colonne, Chantal; Nouet, Aurelien; Chiras, Jacques; Clarençon, Frédéric

2014-05-01

Coiling of ruptured intracranial aneurysms in elderly patients remains debatable in terms of technical feasibility and clinical outcome. In this observational cohort study we aimed to assess the technical feasibility, complication profile and clinical outcomes of elderly patients with subarachnoid hemorrhage (SAH) treated with endovascular therapy. The study included 59 consecutive patients (47 women) aged ≥70 years (mean age 76 years, range 71-84) admitted to our institution with SAH from January 2002 to July 2011. The patients were treated for 66 aneurysms (regular coiling: n=62 (94%), balloon-assisted technique: n=2 (3%), stent and coil technique: n=2 (3%)). World Federation of Neurosurgery (WFNS) grade at admission was 1 in 13 patients, 2 in 23 patients, 3 in 8 patients, 4 in 11 patients and 5 in 4 patients. We analysed data by univariate and multivariate statistical analyses with an emphasis on the initial clinical situation, complications and clinical outcome. The technical success rate was 98% with a procedure-related deficit rate of 10% and procedure-related death rate of 5%. The Glasgow Outcome Scale score at 6 months was 1 in 15 patients (25.4%), 2 in 8 patients (13.6%), 3 in 14 patients (23.7%), 4 in 11 patients (18.6%) and 5 in 11 patients (18.6%). Patients admitted with a high initial WFNS grade did not differ statistically in terms of clinical outcome. The final clinical outcome was not significantly correlated with age, initial Fisher score or procedure-related complications. Endovascular treatment of elderly patients with ruptured cerebral aneurysms is feasible, safe and beneficial regardless of the presenting WFNS score.

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

PubMed

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

2018-06-28

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

The human genome project: Prospects and implications for clinical medicine

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

Green, E.D.; Waterston, R.H.

1991-10-09

The recently initiated human genome project is a large international effort to elucidate the genetic architecture of the genomes of man and several model organisms. The initial phases of this endeavor involve the establishment of rough blueprints (maps) of the genetic landscape of these genomes, with the long-term goal of determining their precise nucleotide sequences and identifying the genes. The knowledge gained by these studies will provide a vital tool for the study of many biologic processes and will have a profound impact on clinical medicine.

Phase 2 Clinical Trial of AC105 (Mg/PEG) for Treatment of Acute Spinal Cord Injury (SCI)

DTIC Science & Technology

2015-12-01

initiation of 10 centers in the first 6 months, and an additional 10 centers over the next 6 months, the subject recruitment phase would have...Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 FDA Approval, Planning & Rolling Initiation of Sites Active phase of study: 6 & 12 month follow-ups Data...analysis Reports The Proposed Milestones for the project were: 1. Month 3 – FDA approval of clinical protocol 2. Month 6 – First site initiation and IRB

Effect of hyperglycaemia on inflammatory and stress responses and clinical outcome of pneumonia in non-critical-care inpatients: results from an observational cohort study.

PubMed

Schuetz, Philipp; Friedli, Natalie; Grolimund, Eva; Kutz, Alexander; Haubitz, Sebastian; Christ-Crain, Mirjam; Thomann, Robert; Zimmerli, Werner; Hoess, Claus; Henzen, Christoph; Mueller, Beat

2014-02-01

Despite the condition's high prevalence, the influence of hyperglycaemia on clinical outcomes in non-critical-care inpatients with infections remains ill defined. In this study, we analysed associations of glucose levels at admission and during initial inpatient treatment with the inflammatory response and clinical outcome in community-acquired pneumonia (CAP) patients. This secondary observational analysis included 880 confirmed CAP patients. We used severity-adjusted multivariate regression models to investigate associations of initial and 96 h mean glucose levels with serially measured biomarker levels over 7 days (C-reactive protein [CRP], procalcitonin, white blood cell count [WBC], pro-adrenomedullin [ProADM]) and adverse clinical course (death and intensive-care unit admission). In the 724 non-diabetic patients (82.3% of the study population), moderate or severe hyperglycaemia (glucose 6-11 mmol/l and >11 mmol/l, respectively) was associated with increased risk for adverse clinical course (adjusted OR [95% CI] 1.4 [0.8, 2.4] and 3.0 [1.1, 8.0], respectively) and with higher CRP, WBC and ProADM levels over 7 days (p < 0.05, ANOVA, all days). In diabetic patients (n = 156), no similar associations were found for initial hyperglycaemia, although mean 96 h glucose levels  ≥ 9 mmol/l were associated with adverse clinical course (adjusted OR 5.4 [1.1, 25.8]; p = 0.03). No effect modification by insulin treatment was detected (interaction terms p > 0.2 for all analyses). Initial hyperglycaemia in non-diabetic CAP patients, and prolonged hyperglycaemia in diabetic or non-diabetic CAP patients, are associated with a more pronounced inflammatory response and CAP-related adverse clinical outcome. Optimal glucose targets for insulin treatment of hyperglycaemia in non-critical-care settings should be defined.

Fate of protocols submitted to a French national funding scheme: a cohort study.

PubMed

Decullier, Evelyne; Huot, Laure; Chapuis, François R

2014-01-01

The fate of clinical research projects funded by a grant has been investigated, but there is no information on the projects which did not receive funding. The fate of these projects is not known: do they apply for and/or receive funding from other sources or are they carried out without specific funding? The aim of the study was to describe all clinical research projects submitted to a French national funding scheme (PHRC 2000) and to assess project initiation, completion and publication status taking into account whether or not they received funding. This study is a retrospective cohort. The initial project characteristics were retrieved from the submission files and follow-up information was collected from the primary investigator. The percentages of projects started, completed and published were studied. A total of 481 projects were studied. Follow-up information was obtained for 366. Overall, 185 projects were initiated (51%); 139 of them were funded by the PHRC 2000 or other sources. The most commonly cited reason for not initiating a project was a lack of funding. Subsequently, 121 of the projects initiated were completed (65%). Accrual difficulties were the main reason cited to explain why studies were stopped prematurely or were still ongoing. Finally, 88 of the completed projects were published (73%). Amongst the completed projects, the only factor explaining publication was the statistical significance of the results. Obtainment of funding was a determining factor for project initiation. However, once initiated, the funding did not influence completion or publication.

The Exceptional Responders Initiative: Welcoming More Cases

Cancer.gov

The initiative is studying tissue, clinical, and genomic data from patients with cancer who have had dramatic and long-lasting responses to standard and experimental treatments that were not seen in similar patients who received the same treatment.

Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation.

PubMed

Manousaki, Despoina; Deladoëy, Johnny; Geoffroy, Louis; Olivier, Patricia

2017-01-01

The occurrence of hypoglycemia and hyperglycemia during the first days after transition to continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes has not been systematically studied in children. The aim of this prospective study was to demonstrate that the protocol applied in our diabetes clinic is safe at CSII initiation in children. We assessed 22 pediatric patients with type 1 diabetes, using continuous glucose monitoring (CGM) before and after CSII initiation (±3 days). After CSII initiation, there was no difference in the rates of hypoglycemic events expressed as relative rates (RRs) per person-reading (RR = 0.85, p  = 0.52, 95% CI 0.52-1.39), as well as in the number of prolonged hypoglycemic events (>1 h) per day (RR = 1.12, p  = 0.56, 95% CI 0.75-1.68). We observed only a trend toward prolonged episodes of hyperglycemia after pump initiation (RR = 1.52, p  = 0.06, 95% CI 0.97-2.35). Our study is the first to assess, through CGM and in a prospective way, the impact of a CSII initiation protocol on glycemic values. Our protocol provides a safe model to avoid hypoglycemia at CSII initiation in children. www.ClinicalTrials.gov, identifier NCT01840358.

Clinical outcomes and nadir prostate-specific antigen (PSA) according to initial PSA levels in primary androgen deprivation therapy for metastatic prostate cancer.

PubMed

Kitagawa, Yasuhide; Ueno, Satoru; Izumi, Kouji; Kadono, Yoshifumi; Mizokami, Atsushi; Hinotsu, Shiro; Akaza, Hideyuki; Namiki, Mikio

2016-03-01

To investigate the clinical outcomes of metastatic prostate cancer patients and the relationship between nadir prostate-specific antigen (PSA) levels and different types of primary androgen deprivation therapy (PADT). This study utilized data from the Japan Study Group of Prostate Cancer registry, which is a large, multicenter, population-based database. A total of 2982 patients treated with PADT were enrolled. Kaplan-Meier analysis was used to compare progression-free survival (PFS) and overall survival (OS) in patients treated using combined androgen blockade (CAB) and non-CAB therapies. The relationships between nadir PSA levels and PADT type according to initial serum PSA levels were also investigated. Among the 2982 enrolled patients, 2101 (70.5 %) were treated with CAB. Although CAB-treated patients had worse clinical characteristics, their probability of PFS and OS was higher compared with those treated with a non-CAB therapy. These results were due to a survival benefit with CAB in patients with an initial PSA level of 500-1000 ng/mL. Nadir PSA levels were significantly lower in CAB patients than in non-CAB patients with comparable initial serum PSA levels. A small survival benefit for CAB in metastatic prostate cancer was demonstrated in a Japanese large-scale prospective cohort study. The clinical significance of nadir PSA levels following PADT was evident, but the predictive impact of PSA nadir on OS was different between CAB and non-CAB therapy.

One thing leads to another: the cascade of obligations when researchers report genetic research results to study participants

PubMed Central

Miller, Fiona Alice; Hayeems, Robin Zoe; Li, Li; Bytautas, Jessica Peace

2012-01-01

Even as debate continues about the putative obligation to proactively report genetic research results to study participants, there is an increasing need to attend to the obligations that might cascade from any initial report. We conducted an international, quasi-experimental survey of researchers involved in autism spectrum disorders (ASD) and cystic fibrosis (CF) genetics to explore perceived obligations to ensure updated information or relevant clinical care subsequent to any initial communication of research results, and factors influencing these attitudes. 5-point Likert scales of dis/agreement were analyzed using descriptive and multivariate statistics. Of the 343 respondents (44% response rate), large majorities agreed that in general and in a variety of hypothetical research contexts, research teams that report results should ensure that participants gain subsequent access to updated information (74–83%) and implicated clinical services (79–87%). At the same time, researchers perceived barriers restricting access to relevant clinical care, though this was significantly more pronounced (P<0.001) for ASD (64%) than CF (34%). In the multivariate model, endorsement of cascading obligations was positively associated with researcher characteristics (eg, clinical role/training) and attitudes (eg, perceived initial reporting obligation), and negatively associated with the initial report of less scientifically robust hypothetical results, but unaffected by perceived or hypothetical barriers to care. These results suggest that researchers strongly endorse information and care-based obligations that cascade from the initial report of research results to study participants. In addition, they raise challenging questions about how any cascading obligations are to be met, especially where access challenges are already prevalent. PMID:22333903

Parkinson's Disease Gene Therapy: Success by Design Meets Failure by Efficacy

PubMed Central

Bartus, Raymond T; Weinberg, Marc S; Samulski, R. Jude

2014-01-01

Over the past decade, nine gene therapy clinical trials for Parkinson's disease (PD) have been initiated and completed. Starting with considerable optimism at the initiation of each trial, none of the programs has yet borne sufficiently robust clinical efficacy or found a clear path toward regulatory approval. Despite the immediately disappointing nature of the efficacy outcomes in these trials, the clinical data garnered from the individual studies nonetheless represent tangible and significant progress for the gene therapy field. Collectively, the clinical trials demonstrate that we have overcome the major safety hurdles previously suppressing central nervous system (CNS) gene therapy, for none produced any evidence of untoward risk or harm after administration of various vector-delivery systems. More importantly, these studies also demonstrated controlled, highly persistent generation of biologically active proteins targeted to structures deep in the human brain. Therefore, a renewed, focused emphasis must be placed on advancing clinical efficacy by improving clinical trial design, patient selection and outcome measures, developing more predictive animal models to support clinical testing, carefully performing retrospective analyses, and most importantly moving forward—beyond our past limits. PMID:24356252

Impact of Initial Vancomycin Trough Concentration on Clinical and Microbiological Outcomes of Methicillin-Resistant Staphylococcus aureus Bacteremia in Children.

PubMed

Yoo, Ree Nar; Kim, Seo Hee; Lee, Jina

2017-01-01

It is important to use vancomycin in a proper manner to ensure optimal drug exposure. Despite extensive use of vancomycin in children, studies on its optimal trough concentration (Ctrough) in the pediatric population remained rare. This retrospective study included children < 18 years old with culture-confirmed methicillin-resistant Staphylococcus aureus (MRSA) bacteremia who were hospitalized in our institute from January 2010 to April 2014. Clinical characteristics, initial vancomycin dose, Ctrough and clinical/microbiological outcomes were retrospectively collected from medical records. Forty-six MRSA bacteremia cases occurring to the patients with a mean age of 22.0 ± 46.9 months were included and all of them were healthcare-associated. Severe diseases requiring intensive care unit (ICU) stay, mechanical ventilation and/or resulting in death were observed in 57.8% (26/45); all-cause 30-day fatality was 11.1% (5/45). An initial Ctrough ≥ 15 μg/mL was achieved in only 4 (8.7%) cases with an average vancomycin dosage of 40.6 ± 7.9 mg/kg/day. Persistent bacteremia at 48 hours after initiation of vancomycin was observed more frequently in children with initial Ctrough < 10 μg/mL than in those with Ctrough ≥ 10 μg/mL (P = 0.032). However, there was no statistically significant difference between the two groups in terms of 30-day mortality and recurrent bacteremia (P = 0.899, and P = 0.754, respectively). Although initial Ctrough may be a useful parameter for minimizing early microbiological failure, it does not predict 30-day fatality or recurrence in pediatric MRSA bacteremia. Further prospective data on vancomycin dosing are needed to find the optimal drug exposure and clarify its impact on clinical outcomes in pediatric populations.

Initial 12-h operative fluid volume is an independent risk factor for pleural effusion after hepatectomy.

PubMed

Cheng, Xiang; Wu, Jia-Wei; Sun, Ping; Song, Zi-Fang; Zheng, Qi-Chang

2016-12-01

Pleural effusion after hepatectomy is associated with significant morbidity and prolonged hospital stays. Several studies have addressed the risk factors for postoperative pleural effusion. However, there are no researches concerning the role of the initial 12-h operative fluid volume. The aim of this study was to evaluate whether the initial 12-h operative fluid volume during liver resection is an independent risk factor for pleural effusion after hepatectomy. In this study, we retrospectively analyzed clinical data of 470 patients consecutively undergoing elective hepatectomy between January 2011 and December 2012. We prospectively collected and retrospectively analyzed baseline and clinical data, including preoperative, intraoperative, and postoperative variables. Univariate and multivariate analyses were carried out to identify whether the initial 12-h operative fluid volume was an independent risk factor for pleural effusion after hepatectomy. The multivariate analysis identified 2 independent risk factors for pleural effusion: operative time [odds ratio (OR)=10.2] and initial 12-h operative fluid volume (OR=1.0003). Threshold effect analyses revealed that the initial 12 h operative fluid volume was positively correlated with the incidence of pleural effusion when the initial 12-h operative fluid volume exceeded 4636 mL. We conclude that the initial 12-h operative fluid volume during liver resection and operative time are independent risk factors for pleural effusion after hepatectomy. Perioperative intravenous fluids should be restricted properly.

Longitudinal Assessment of Health-Related Quality of Life following Adolescent Sports-Related Concussion.

PubMed

Russell, Kelly; Selci, Erin; Chu, Stephanie; Fineblit, Samuel; Ritchie, Lesley; Ellis, Michael J

2017-07-01

To examine initial and longitudinal health-related quality of life (HRQOL) in adolescent sports-related concussion (SRC) patients, a prospective observational case-series study was conducted among adolescent SRC patients who were evaluated at a multi-disciplinary pediatric concussion program. Health-related quality of life was measured using the child self-report Pediatric Quality of Life Inventory (PedsQL) generic score scale (age 13-18 version) and the PedsQL Cognitive Functioning scale. Initial and longitudinal HRQOL outcomes were compared between patients who did and did not develop post-concussion syndrome (PCS). A total of 63 patients met the inclusion criteria during the study period. The mean age of the cohort was 14.57 years (standard deviation, 1.17) and 61.9% were male. The median time from injury to initial consultation was 6.5 days (interquartile range, 5, 11). At initial consultation, impairments in physical and cognitive HRQOL but not social or emotional HRQOL were observed. Initial symptom burden and length of recovery were associated with greater impairment in physical and cognitive HRQOL. Patients who went on to develop PCS had significantly worse physical and cognitive HRQOL at initial consultation and demonstrated a slower rate of recovery in these domains, compared with those who recovered in less than 30 days. Adolescent SRC was associated with HRQOL impairments that correlated with clinical outcomes. No persistent impairments in HRQOL were detected among patients who achieved physician-documented clinical recovery. Future studies are needed to evaluate the clinical utility of HRQOL measurement in the longitudinal management of adolescent SRC and PCS patients.

Association Between Complementary and Alternative Medicine Use and Breast Cancer Chemotherapy Initiation: The Breast Cancer Quality of Care (BQUAL) Study.

PubMed

Greenlee, Heather; Neugut, Alfred I; Falci, Laura; Hillyer, Grace Clarke; Buono, Donna; Mandelblatt, Jeanne S; Roh, Janise M; Ergas, Isaac J; Kwan, Marilyn L; Lee, Marion; Tsai, Wei Yann; Shi, Zaixing; Lamerato, Lois; Kushi, Lawrence H; Hershman, Dawn L

2016-09-01

Not all women initiate clinically indicated breast cancer adjuvant treatment. It is important for clinicians to identify women at risk for noninitiation. To determine whether complementary and alternative medicine (CAM) use is associated with decreased breast cancer chemotherapy initiation. In this multisite prospective cohort study (the Breast Cancer Quality of Care [BQUAL] study) designed to examine predictors of breast cancer treatment initiation and adherence, 685 women younger than 70 years with nonmetastatic invasive breast cancer were recruited from Columbia University Medical Center, Kaiser Permanente Northern California, and Henry Ford Health System and enrolled between May 2006 and July 31, 2010. Overall, 306 patients (45%) were clinically indicated to receive chemotherapy per National Comprehensive Cancer Network guidelines. Participants were followed for up to 12 months. Baseline interviews assessed current use of 5 CAM modalities (vitamins and/or minerals, herbs and/or botanicals, other natural products, mind-body self-practice, mind-body practitioner-based practice). CAM use definitions included any use, dietary supplement use, mind-body use, and a CAM index summing the 5 modalities. Chemotherapy initiation was assessed via self-report up to 12 months after baseline. Multivariable logistic regression models examined a priori hypotheses testing whether CAM use was associated with chemotherapy initiation, adjusting for demographic and clinical covariates, and delineating groups by age and chemotherapy indication. A cohort of 685 women younger than 70 years (mean age, 59 years; median age, 59 years) with nonmetastatic invasive breast cancer were recruited and followed for up to 12 months to examine predictors of breast cancer treatment initiation. Baseline CAM use was reported by 598 women (87%). Chemotherapy was initiated by 272 women (89%) for whom chemotherapy was indicated, compared with 135 women (36%) for whom chemotherapy was discretionary. Among women for whom chemotherapy was indicated, dietary supplement users and women with high CAM index scores were less likely than nonusers to initiate chemotherapy (odds ratio [OR], 0.16; 95% CI, 0.03-0.51; and OR per unit, 0.64; 95% CI, 0.46-0.87, respectively). Use of mind-body practices was not related to chemotherapy initiation (OR, 1.45; 95% CI, 0.57-3.59). There was no association between CAM use and chemotherapy initiation among women for whom chemotherapy was discretionary. CAM use was high among patients with early-stage breast cancer enrolled in a multisite prospective cohort study. Current dietary supplement use and higher number of CAM modalities used but not mind-body practices were associated with decreased initiation of clinically indicated chemotherapy. Oncologists should consider discussing CAM with their patients during the chemotherapy decision-making process.

Hydroxyurea Effectiveness in Children and Adolescents with Sickle Cell Anemia: A Large Retrospective, Population-Based Cohort

PubMed Central

Quarmyne, Maa-Ohui; Dong, Wei; Theodore, Rodney; Anand, Sonia; Barry, Vaughn; Adisa, Olufolake; Buchanan, Iris D.; Bost, James; Brown, Robert C.; Joiner, Clinton H.; Lane, Peter A.

2016-01-01

The clinical efficacy of hydroxyurea in patients with sickle cell anemia (SCA) has been well established. However, data about its clinical effectiveness in practice is limited. We evaluated the clinical effectiveness of hydroxyurea in a large pediatric population using a retrospective cohort, pre-post treatment study design to control for disease severity selection bias. The cohort included children with SCA (SS, S β 0thalassemia) who received care at Children's Healthcare of Atlanta (CHOA) and who initiated hydroxyurea in 2009-2011. Children on chronic transfusions, or children with inadequate follow up data and/or children who had taken hydroxyurea in the 3 years prior were excluded. For each patient, healthcare utilization, laboratory values and clinical outcomes for the 2-year period prior to hydroxyurea initiation were compared to those 2 years after initiation. Of 211 children with SCA who initiated hydroxyurea in 2009-2011, 134 met eligibility criteria. After initiation of hydroxyurea, rates of hospitalizations, pain encounters, and emergency department visits were reduced by 47% (<0.0001), 36% (p=0.0001) and 43% (p<0.0001), respectively. Average hemoglobin levels increased by 0.7g/dl (p<0.0001). Hydroxyurea effectiveness was similar across gender, insurance types and age, although there was a slightly greater reduction in hospitalizations in younger children. PMID:27761932

Effectiveness of a Simulated Clinical Examination in the Assessment of the Clinical Competencies of Entry-Level Trainees in a Family Medicine Residency Programme

ERIC Educational Resources Information Center

Curran, Vernon R.; Butler, Roger; Duke, Pauline; Eaton, William H.; Moffatt, Scott M.; Sherman, Greg P.; Pottle, Madge

2012-01-01

Clinical competence is a multidimensional concept and encompasses a variety of skills including procedural, problem-solving and clinical judgement. The initial stages of postgraduate medical training are believed to be a particularly important time for the development of clinical skill competencies. This study reports on an evaluation of a…

Physiotherapy in Primary Care Triage - the effects on utilization of medical services at primary health care clinics by patients and sub-groups of patients with musculoskeletal disorders: a case-control study.

PubMed

Bornhöft, Lena; Larsson, Maria E H; Thorn, Jörgen

2015-01-01

Primary Care Triage is a patient sorting system used in some primary health care clinics (PHCCs) in Sweden where patients with musculoskeletal disorders (MSD) are triaged directly to physiotherapists. The purpose of this study was to investigate whether sorting/triaging patients seeking a PHCC for MSD directly to physiotherapists affects their utilization of medical services at the clinic for the MSD and to determine whether the effects of the triaging system vary for different sub-groups of patients. A retrospective case-control study design was used at two PHCCs. At the intervention clinic, 656 patients with MSD were initially triaged to physiotherapists. At the control clinic, 1673 patients were initially assessed by general practitioners (GPs). The main outcome measures were the number of patients continuing to visit GPs after the initial assessment, the number of patients receiving referrals to specialists/external examinations, doctors' notes for sick-leave or prescriptions for analgesics during one year, all for the original MSD. Significantly fewer patients triaged to physiotherapists required multiple GP visits for the MSD or received MSD-related referrals to specialists/external examinations, sick-leave recommendations or prescriptions during the following year compared to the GP-assessed group. This applies to all sub-groups except for the group with lower extremity disorders, which did not reach significance for either multiple GP visits or sick-leave recommendations. The reduced utilization of medical services by patients with MSD who were triaged to physiotherapists at a PHCC is likely due to altered management of MSD with initial assessment by physiotherapists.

Korean guidelines for the diagnosis and management of dry eye: development and validation of clinical efficacy.

PubMed

Hyon, Joon Young; Kim, Hyo-Myung; Lee, Doh; Chung, Eui-Sang; Song, Jong-Suk; Choi, Chul Young; Lee, Jungbok

2014-06-01

To evaluate the clinical efficacy of newly developed guidelines for the diagnosis and management of dry eye. This retrospective, multi-center, non-randomized, observational study included a total of 1,612 patients with dry eye disease who initially visited the clinics from March 2010 to August 2010. Korean guidelines for the diagnosis and management of dry eye were newly developed from concise, expert-consensus recommendations. Severity levels at initial and final visits were determined using the guidelines in patients with 90 ± 7 days of follow-up visits (n = 526). Groups with different clinical outcomes were compared with respect to clinical parameters, treatment modalities, and guideline compliance. Main outcome measures were ocular and visual symptoms, ocular surface disease index, global assessment by patient and physician, tear film break-up time, Schirmer-1 test score, ocular surface staining score at initial and final visits, clinical outcome after three months of treatment, and guideline compliance. Severity level was reduced in 47.37% of patients treated as recommended by the guidelines. Younger age (odd ratio [OR], 0.984; p = 0.044), higher severity level at initial visit, compliance to treatment recommendation (OR, 1.832; p = 0.047), and use of topical cyclosporine (OR, 1.838; p = 0.011) were significantly associated with improved clinical outcomes. Korean guidelines for the diagnosis and management of dry eye can be used as a valid and effective tool for the treatment of dry eye disease.

Dental Hygienists' Perceptions of Preparedness for Clinical Practice: A Phenomenological Study

ERIC Educational Resources Information Center

Cantrell, Lezlie M.

2012-01-01

The purpose of this phenomenological study was to identify, compile, and describe how community college graduate dental hygienists perceived their initial dental hygiene curriculum preparation and how they subsequently adapted their curriculum preparation in order to perform their responsibilities in their first clinical dental hygiene job.…

[Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

PubMed

Shimada, Yasuhiro

2016-04-01

The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration to Accelerate Diagnosis and Treatment of Traumatic Brain Injury.

PubMed

Manley, Geoffrey T; MacDonald, Christine L; Markowitz, Amy; Stephenson, Diane; Robbins, Ann; Gardner, Raquel C; Winkler, Ethan A; Bodien, Yelena; Taylor, Sabrina; Yue, John K; Kannan, Lakshmi; Kumar, Allison; McCrea, Michael; Wang, Kevin K W

2017-03-31

The Traumatic Brain Injury Endpoints Development (TED) Initiative is a 5-year, Department of Defense (DoD) funded project that is working toward the ultimate goal of developing better designed clinical trials, leading to more precise diagnosis, and effective treatments for traumatic brain injury (TBI). TED is comprised of leading academic clinician-scientists, along with innovative industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropists, working collaboratively with regulatory authorities, specifically the US Food and Drug Administration (FDA). The goals of the TED Initiative are to gain consensus and validation of TBI clinical outcome assessment measures and biomarkers for endorsement by global regulatory agencies for use in drug and device development processes. This manuscript summarizes the Initiative's Stage 1 progress over the first 18 months, including intensive engagement with a number of FDA divisions responsible for review and validation of biomarkers and clinical outcome assessments, progression into the prequalification phase of FDA's Medical Device Development Tool program for a candidate set of neuroimaging biomarkers, and receipt of FDA's Recognition of Research Importance Letter regarding TBI. Other signal achievements relate to the creation of the TED Metadataset, harmonizing study measures across eight major TBI studies, and the leadership role played by TED investigators in the conversion of the NINDS TBI Common Data Elements (CDEs) to Clinical Data Interchange Standards Consortium (CDISC) standards. This paper frames both the near-term expectations and the Initiative's long-term vision to accelerate approval of treatments for patients affected by TBI in urgent need of effective therapies.

Review of proton pump inhibitors for the initial treatment of heartburn: is there a dose ceiling effect?

PubMed

Kushner, Pamela R; Peura, David A

2011-05-01

Proton pump inhibitors (PPIs) are widely used in clinical practice. However, concerns have been expressed about their long-term use, particularly with regard to bone health, Clostridium difficile infections, and drug interactions with platelet aggregation inhibitors. There has been limited guidance for clinicians concerning appropriate dose selection of PPIs for the initial treatment of heartburn. This review explored whether published clinical trials provide evidence of a ceiling above which higher PPI doses do not provide additional clinical benefit over the lowest approved dose. All articles of randomized, controlled clinical trials in nonerosive gastroesophageal reflux disease (GERD) in which the effects of two or more doses of the same PPI on symptomatic relief of heartburn were quantified as a study endpoint were identified and analyzed through PubMed searches up to the end of September 2010. The majority of trials evaluated provided no evidence that higher PPI doses were superior to the lowest approved dose for the initial treatment of heartburn. There were no clinically relevant findings with respect to dose dependence and safety outcomes in these studies. Efficacy outcomes from the trials suggest there may be a dose ceiling effect and highlight the need for further research on the use of the lowest effective PPI doses as an appropriate strategy in the initial treatment of uncomplicated heartburn. Observational studies and some meta-analyses have suggested that long-term PPI pharmacotherapy might be associated with safety concerns, which necessitate the periodic evaluation of therapeutic benefit in terms of symptom resolution and regimen tolerability. However, evidence to date suggests that use of the lowest effective dose for the indication is not associated with significant adverse events, particularly in the short term. Clinical practice suggests that patients requiring long-term treatment should be maintained on the lowest dose necessary to control symptoms, and monitored for potentially confounding factors that may lead to safety concerns.

Investigator initiated IBD trials in the US: Facts, obstacles and answers

PubMed Central

Herfarth, Hans H; Jackson, Susan; Schliebe, Barbara G.; Martin, Christopher; Ivanova, Anastasia; Anton, Kristen; Sandler, Robert S; Long, Millie D; Isaacs, Kim L; Osterman, Mark T; Sands, Bruce E; Higgins, Peter D; Lewis, James D

2016-01-01

Investigator initiated randomized clinical trials (IITs) are the backbone of academic clinical research. IITs complement the large clinical studies sponsored by industry and address questions, which are usually not the main focus of a commercially directed research but have the purpose to confirm, improve or refute clinically important questions with regard to diagnostic and therapeutic approaches in patient care. The aim of this review is to illustrate the necessary steps to start and complete an IIT in the field of inflammatory bowel diseases (IBD) in the US. The initial milestones for an investigator include structuring a protocol, planning and building of the trial infrastructure, accurately estimating the costs of the trial and gauging the time span for recruitment. Once the trial has begun it is important to keep patient recruitment on target, monitor of the data quality, and document treatment emergent adverse events. This article provides a framework for the different phases of an IIT and outlines potential hurdles, which could hinder a successful execution. PMID:27598744

Sex issues in HIV-1-infected persons during highly active antiretroviral therapy: a systematic review.

PubMed

Nicastri, Emanuele; Leone, Sebastiano; Angeletti, Claudio; Palmisano, Lucia; Sarmati, Loredana; Chiesi, Antonio; Geraci, Andrea; Vella, Stefano; Narciso, Pasquale; Corpolongo, Angela; Andreoni, Massimo

2007-10-01

Since the introduction of highly active antiretroviral therapy (HAART), morbidity and mortality rates have sharply decreased among HIV-infected patients. Studies of possible differences between men and women in the course of HIV infection give conflicting results. The objective of this study was to assess sex differences during HAART. A literature search by using the MEDLINE database between March 2002 and February 2007 was performed to identify all published studies on the sex-specific differences on the impact of HAART. All articles with measures of effect (preferably adjusted odds ratio, relative risk or hazard ratio with 95% CI) of sex on viroimmunological and clinical parameters during HAART were included. Five different topics of interest in our research were selected: time of initiation of HAART, adherence, viroimmunological response, clinical response and adverse reactions during HAART. US data report an initiation of HAART at an earlier disease stage in men compared with women. After initiation of HAART, most authors do not report any viroimmunological difference, although a few clinical studies showed a significantly better virological response in women compared with men. Nevertheless, women were more likely to be less adherent to antiretrovirals and to have non-structured treatment interruptions than men. This is likely to be related to the higher number of adverse reactions they experience during HAART. Finally, discordant opinions with regard to clinical benefits during HAART exist, but recent clinical and observational trials suggest a better clinical outcome for women. We found little evidence of sex differences during antiretroviral treatment. Nevertheless, most of these studies were underpowered to detect sex differences and had limited follow-up at 6 or 12 months. Design of new gender-sensitive clinical trials with both prolonged follow-up and sample size representative of the current HIV prevalence among women are strongly needed to detect the likely sex differences of antiretroviral agents during HIV infection.

The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS): Establishing a New Interdisciplinary Self-Assessment for Health Providers.

PubMed

Bidell, Markus P

2017-01-01

These three studies provide initial evidence for the development, factor structure, reliability, and validity of the Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS), a new interdisciplinary LGBT clinical self-assessment for health and mental health providers. Research participants were voluntarily recruited in the United States and United Kingdom and included trainees, clinicians, and educators from applied psychology, counseling, psychotherapy, and primary care medicine. Study 1 (N = 602) used exploratory and confirmatory factor analytic techniques, revealing an 18-item three-factor structure (Clinical Preparedness, Attitudinal Awareness, and Basic Knowledge). Study 2 established internal consistency for the overall LGBT-DOCSS (α = .86) and for each of the three subscales (Clinical Preparedness = .88, Attitudinal Awareness = .80, and Basic Knowledge = .83) and 2-week test-retest reliability (.87). In study 3 (N = 564), participant criteria (sexual orientation and education level) and four established scales that measured LGBT prejudice, assessment skills, and social desirability were used to support initial content and discriminant validity. Psychometric properties, limitations, and recommendations are discussed.

Fibroblasts—a key host cell type in tumor initiation, progression, and metastasis

PubMed Central

Strell, Carina; Rundqvist, Helene

2012-01-01

Tumor initiation, growth, invasion, and metastasis occur as a consequence of a complex interplay between the host environment and cancer cells. Fibroblasts are now recognized as a key host cell type involved in host–cancer signaling. This review discusses some recent studies that highlight the roles of fibroblasts in tumor initiation, early progression, invasion, and metastasis. Some clinical studies describing the prognostic significance of fibroblast-derived markers and signatures are also discussed. PMID:22509805

Consequences of germline variation disrupting the constitutional translational initiation codon start sites of MLH1 and BRCA2: use of potential alternative start sites and implications for predicting variant pathogenicity

PubMed Central

Parsons, Michael T.; Whiley, Phillip J.; Beesley, Jonathan; Drost, Mark; de Wind, Niels; Thompson, Bryony A.; Marquart, Louise; Hopper, John L.; Jenkins, Mark A.; Brown, Melissa A.; Tucker, Kathy; Warwick, Linda; Buchanan, Daniel D.; Spurdle, Amanda B.

2014-01-01

Variants that disrupt the translation initiation sequences in cancer predisposition genes are generally assumed to be deleterious. However few studies have validated these assumptions with functional and clinical data. Two cancer syndrome gene variants likely to affect native translation initiation were identified by clinical genetic testing: MLH1:c.1A>G p.(Met1?) and BRCA2:c.67+3A>G. In vitro GFP-reporter assays were conducted to assess the consequences of translation initiation disruption on alternative downstream initiation codon usage. Analysis of MLH1:c.1A>G p.(Met1?) showed that translation was mostly initiated at an in-frame position 103 nucleotides downstream, but also at two ATG sequences downstream. The protein product encoded by the in-frame transcript initiating from position c.103 showed loss of in vitro mismatch repair activity comparable to known pathogenic mutations. BRCA2:c.67+3A>G was shown by mRNA analysis to result in an aberrantly spliced transcript deleting exon 2 and the consensus ATG site. In the absence of exon 2, translation initiated mostly at an out-of-frame ATG 323 nucleotides downstream, and to a lesser extent at an in-frame ATG 370 nucleotides downstream. Initiation from any of the downstream alternative sites tested in both genes would lead to loss of protein function, but further clinical data is required to confirm if these variants are associated with a high cancer risk. Importantly, our results highlight the need for caution in interpreting the functional and clinical consequences of variation that leads to disruption of the initiation codon, since translation may not necessarily occur from the first downstream alternative start site, or from a single alternative start site. PMID:24302565

Characteristics and Causes for Non-Accrued Clinical Research (NACR) at an Academic Medical Institution

PubMed Central

Tice, Debra G.; Carroll, Kelly A.; Bhatt, Karishma H.; Belknap, Steven M.; Mai, David; Gipson, Heather J.; West, Dennis P.

2013-01-01

Background The impact of non-accrued clinical research (NACR) represents an important economic burden that is under consideration as the U.S. Department of Health and Human Services looks into reforming the regulations governing IRB review. NACR refers to clinical research projects that fail to enroll subjects. A delineation of the issues surrounding NACR is expected to enhance subject accrual and to minimize occurrence of NACR. The authors assessed demographics, characteristics, and reasons for NACR at an academic medical center, including time trends, funding source, research team (principal investigator, department), IRB resource utilization (IRB level of review, number of required IRB reviews, initial IRB turn-around time, and duration of NACR). Methods The authors analyzed data from 848 clinical research study closures during 2010 and 2011 to determine proportion, incidence, and characteristics of NACR. Studies with subject enrollment during the same time period were used as a comparative measure. Results Data from 704 (83.0%) study closures reported enrollment of 1 or more subjects while 144 (17.0 %) reported NACR (zero enrollment). PI-reported reasons for NACR included: 32 (22.2%) contract or funding issues; 43 (30.0%) insufficient study-dedicated resources; 41 (28.4%) recruitment issues; 17 (11.8%) sponsor-initiated study closure and 11 (7.6%) were “other/reason unreported”. Conclusions NACR is not uncommon, affecting about one in six clinical research projects in the study population and reported to be more common in some other institutions. The complex and fluid nature of research conduct, non-realistic enrollment goals, and delays in both the approval and/or accrual processes contribute to NACR. Results suggest some simple strategies that investigators and institutions may use to reduce NACR, including careful feasibility assessment, reduction of institutional delays, and prompt initiation of subject accrual for multi-center studies using competitive enrollment. Institutional action to support investigators in the conduct clinical research is also encouraged to reduce likelihood of NACR. PMID:23671544

Characteristics and Causes for Non-Accrued Clinical Research (NACR) at an Academic Medical Institution.

PubMed

Tice, Debra G; Carroll, Kelly A; Bhatt, Karishma H; Belknap, Steven M; Mai, David; Gipson, Heather J; West, Dennis P

2013-06-01

The impact of non-accrued clinical research (NACR) represents an important economic burden that is under consideration as the U.S. Department of Health and Human Services looks into reforming the regulations governing IRB review. NACR refers to clinical research projects that fail to enroll subjects. A delineation of the issues surrounding NACR is expected to enhance subject accrual and to minimize occurrence of NACR. The authors assessed demographics, characteristics, and reasons for NACR at an academic medical center, including time trends, funding source, research team (principal investigator, department), IRB resource utilization (IRB level of review, number of required IRB reviews, initial IRB turn-around time, and duration of NACR). The authors analyzed data from 848 clinical research study closures during 2010 and 2011 to determine proportion, incidence, and characteristics of NACR. Studies with subject enrollment during the same time period were used as a comparative measure. Data from 704 (83.0%) study closures reported enrollment of 1 or more subjects while 144 (17.0 %) reported NACR (zero enrollment). PI-reported reasons for NACR included: 32 (22.2%) contract or funding issues; 43 (30.0%) insufficient study-dedicated resources; 41 (28.4%) recruitment issues; 17 (11.8%) sponsor-initiated study closure and 11 (7.6%) were "other/reason unreported". NACR is not uncommon, affecting about one in six clinical research projects in the study population and reported to be more common in some other institutions. The complex and fluid nature of research conduct, non-realistic enrollment goals, and delays in both the approval and/or accrual processes contribute to NACR. Results suggest some simple strategies that investigators and institutions may use to reduce NACR, including careful feasibility assessment, reduction of institutional delays, and prompt initiation of subject accrual for multi-center studies using competitive enrollment. Institutional action to support investigators in the conduct clinical research is also encouraged to reduce likelihood of NACR.

Research Areas - Clinical Trials

Cancer.gov

Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

Bayesian analysis of a mastitis control plan to investigate the influence of veterinary prior beliefs on clinical interpretation.

PubMed

Green, M J; Browne, W J; Green, L E; Bradley, A J; Leach, K A; Breen, J E; Medley, G F

2009-10-01

The fundamental objective for health research is to determine whether changes should be made to clinical decisions. Decisions made by veterinary surgeons in the light of new research evidence are known to be influenced by their prior beliefs, especially their initial opinions about the plausibility of possible results. In this paper, clinical trial results for a bovine mastitis control plan were evaluated within a Bayesian context, to incorporate a community of prior distributions that represented a spectrum of clinical prior beliefs. The aim was to quantify the effect of veterinary surgeons' initial viewpoints on the interpretation of the trial results. A Bayesian analysis was conducted using Markov chain Monte Carlo procedures. Stochastic models included a financial cost attributed to a change in clinical mastitis following implementation of the control plan. Prior distributions were incorporated that covered a realistic range of possible clinical viewpoints, including scepticism, enthusiasm and uncertainty. Posterior distributions revealed important differences in the financial gain that clinicians with different starting viewpoints would anticipate from the mastitis control plan, given the actual research results. For example, a severe skeptic would ascribe a probability of 0.50 for a return of < 5 UK pounds per cow in an average herd that implemented the plan, whereas an enthusiast would ascribe this probability for a return of > 20 UK pounds per cow. Simulations using increased trial sizes indicated that if the original study was four times as large, an initial skeptic would be more convinced about the efficacy of the control plan but would still anticipate less financial return than an initial enthusiast would anticipate after the original study. In conclusion, it is possible to estimate how clinicians' prior beliefs influence their interpretation of research evidence. Further research on the extent to which different interpretations of evidence result in changes to clinical practice would be worthwhile.

[Central nervous tuberculosis in patients non-VIH: seven case reports].

PubMed

Mazodier, K; Bernit, E; Faure, V; Rovery, C; Gayet, S; Seux, V; Donnet, A; Brouqui, P; Disdier, P; Schleinitz, N; Kaplanski, G; Veit, V; Harlé, J-R

2003-02-01

Tuberculosis involving the central nervous system (CNS) is rarely observed in non immuno-compromised hosts. We report herin the various clinical, biological and radiological manifestations observed in 7 patients with CNS tuberculosis. Clinical and biological records of 7 patients with CNS tuberculosis were retrospectively studied. All patients had encephalic CT-scan and MRI in the course of the disease. 5 women and 2 men with a mean age of 38.4 years initially initially presented with headache (n = 6), fever (n = 5), meningeal irritation (n = 3), localizing neurological signs (n = 1). Lumbar punction revealed lymphocytic meningitis (n = 6/7). Mycobacterium tuberculosis or bovis was isolated in 3 patients only. Cerebral tomodensitography or magnetic resonance imaging were initially normal in most of cases (n = 4/7), but discovered in the course of disease basilar meningitis (n = 6), hydrocephalus (n = 6), abcess or tuberculoma (n = 4). In all the patients, initiation of the treatment was complicated by clinical and/or biological deterioration, called paradoxal reaction, leading in all cases to glucocorticoid adjunction, with various final results. Indeed, 4 patients developed neurological sequelae. No patient died. CNS tuberculosis is a rare disease in non immunocompromised patients whose diagnostic may be difficult due to the absence of specific clinical symptoms, negative initial radiological examination, as well as delayed and often negative bacterial isolation. Paradoxal reaction appeared to be frequent despite specific antibiotherapy and underlines the beneficial effects of addictive corticosteroids.

Hydroxyurea effectiveness in children and adolescents with sickle cell anemia: A large retrospective, population-based cohort.

PubMed

Quarmyne, Maa-Ohui; Dong, Wei; Theodore, Rodney; Anand, Sonia; Barry, Vaughn; Adisa, Olufolake; Buchanan, Iris D; Bost, James; Brown, Robert C; Joiner, Clinton H; Lane, Peter A

2017-01-01

The clinical efficacy of hydroxyurea in patients with sickle cell anemia (SCA) has been well established. However, data about its clinical effectiveness in practice is limited. We evaluated the clinical effectiveness of hydroxyurea in a large pediatric population using a retrospective cohort, pre-post treatment study design to control for disease severity selection bias. The cohort included children with SCA (SS, Sβ 0 thalassemia) who received care at Children's Healthcare of Atlanta (CHOA) and who initiated hydroxyurea in 2009-2011. Children on chronic transfusions, or children with inadequate follow up data and/or children who had taken hydroxyurea in the 3 years prior were excluded. For each patient healthcare utilization, laboratory values, and clinical outcomes for the 2-year period prior to hydroxyurea initiation were compared to those 2 years after initiation. Of 211 children with SCA who initiated hydroxyurea in 2009-2011, 134 met eligibility criteria. After initiation of hydroxyurea, rates of hospitalizations, pain encounters, and emergency department visits were reduced by 47% (<0.0001), 36% (P = 0.0001) and 43% (P < 0.0001), respectively. Average hemoglobin levels increased by 0.7 g/dl (P < 0.0001). Hydroxyurea effectiveness was similar across gender, insurance types and age, although there was a slightly greater reduction in hospitalizations in younger children. Am. J. Hematol. 92:77-81, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Plain radiologic findings and chronological changes of incipient phase osteosarcoma overlooked by primary physicians.

PubMed

Song, Won Seok; Jeon, Dae-Geun; Cho, Wan Hyeong; Kong, Chang-Bae; Cho, Sang Hyun; Lee, Jung Wook; Lee, Soo-Yong

2014-06-01

We assessed the plain radiographic characteristics of 10 cases of osteosarcomas during the initial painful period that had been overlooked by a primary physician. In addition, we evaluated chronologic changes in radiographic findings from initial symptomatic period to the time of accurate diagnosis. The clinical records were reviewed for clinical parameters including age, sex, location, presenting symptoms, initial diagnosis, duration from initial symptoms to definite diagnosis, and initial and follow-up plain radiographic findings of the lesion. Initial clinical diagnoses included a sprain in 6, growing pain in 2, stress fracture in 1, and infection in 1 patient. Initial plain radiographic findings were trabecular destruction (100%), cortical disruption (60%), periosteal reaction (60%), and soft tissue mass (10%). Intramedullary matrix changes were osteosclerosis in 6 and osteolysis in 4 patients. On progression, 4 cases with minimal sclerosis changed to osteoblastic lesion in 3 patients and osteolytic lesion in 1. Four cases with faint osteolytic foci transformed into osteolytic lesion in 3 and mixed pattern in 1. Notable plain radiologic findings of incipient-stage osteosarcoma include trabecular disruption along with faint osteosclerosis or osteolysis. In symptomatic patients with trabecular destruction, additional imaging study including magnetic resonance imaging should be performed to exclude osteosarcoma in the incipient phase, even without radiologic findings suggesting malignant tumor, such as cortical destruction or periosteal reaction.

CROI 2018: Advances in Antiretroviral Therapy.

PubMed

Tieu, Hong-Van; Taylor, Barbara S; Jones, Joyce; Wilkin, Timothy J

2018-05-01

The 2018 Conference on Retroviruses and Opportunistic Infections (CROI) showcased exciting data on new investigational agents including MK-8591 and tri-specific antibody targeting 3 highly conserved epitopes on HIV-1 in a single antibody. Clinical trials of initial antiretroviral therapy (ART) and switch studies involving bictegravir/emtricitabine/tenofovir alafenamide were presented. Intensification of initial ART with integrase strand transfer inhibitors did not increase the risk of immune reconstitution inflammatory syndrome. Pharmacokinetic issues were discussed, including the substantial drug-drug interactions between efavirenz-based ART and hormonal contraception delivered via a vaginal ring. Studies on pre-ART drug resistance and emergence of drug resistance after initial and second-line ART in different settings and populations were highlighted. Novel technologies to identify drug resistance included a free, cloud-based web service for HIV genotyping analysis and a promising technology for point-of-care drug resistance mutations testing. New strategies to improve the HIV care continuum included home-based testing with initiation of same-day ART and stratified care with specialized clinics to serve those disengaged in care, but the data on financial incentives were not encouraging. Several studies provided insights into the impact of early ART on decreasing the size of the HIV reservoir in HIV-infected infants. Pertinent conference findings relating to women's health issues included similar clinical outcomes between breastfeeding and formula feeding HIV-infected women, the problem of viral rebound and ART nonadherence in pregnancy and postpartum.

Cardiovascular point of care initiative: enhancements in clinical data management.

PubMed

Robertson, Jane

2003-01-01

The Department of Cardiovascular Surgery at East Alabama Medical Center (EAMC) initiated a program in 1996 to improve the quality and usefulness of clinical outcomes data. After years of using a commercial vendor product and enduring a tedious collection process, the department decided to develop its own tools to support quality improvement efforts. Using a hand-held personal data assistant (PDA), the team developed tools that allowed ongoing data collection at the point of care delivery. The tools and methods facilitated the collection of real time, accurate information that allowed EAMC to participate in multiple clinical quality initiatives. The ability to conduct rapid-cycle performance improvement studies propelled EAMC's Cardiovascular Surgery Program into the Top 100 as recognized by HCIA, now Solucient, for 3 consecutive years (1999-2001). This report will describe the evolution of the data collection process as well as the quality improvements that resulted.

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

PubMed

Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

2018-03-01

Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

The Reliability, Validity, and Evaluation of the Objective Structured Clinical Examination in Podiatry (Chiropody).

ERIC Educational Resources Information Center

Woodburn, Jim; Sutcliffe, Nick

1996-01-01

The Objective Structured Clinical Examination (OSCE), initially developed for undergraduate medical education, has been adapted for assessment of clinical skills in podiatry students. A 12-month pilot study found the test had relatively low levels of reliability, high construct and criterion validity, and good stability of performance over time.…

A Study of Critical Reflection in Health Professional Education: "Learning Where Others Are Coming from"

ERIC Educational Resources Information Center

Delany, Clare; Watkin, Deborah

2009-01-01

A dominant focus of clinical education for health professional students is experiential learning through an apprentice model where students are exposed to a range of clinical scenarios and conditions through observation initially, and then through supervised clinical practice. However experiential learning may not be enough to meet the need for…

Experiences of Student Speech-Language Pathology Clinicians in the Initial Clinical Practicum: A Phenomenological Study

ERIC Educational Resources Information Center

Nelson, Lori A.

2011-01-01

Speech-language pathology literature is limited in describing the clinical practicum process from the student perspective. Much of the supervision literature in this field focuses on quantitative research and/or the point of view of the supervisor. Understanding the student experience serves to enhance the quality of clinical supervision. Of…

Safety and efficacy of pirfenidone in idiopathic pulmonary fibrosis in clinical practice.

PubMed

Okuda, Ryo; Hagiwara, Eri; Baba, Tomohisa; Kitamura, Hideya; Kato, Terufumi; Ogura, Takashi

2013-09-01

Previous pirfenidone trials have only involved patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF). The aim of this study was to investigate the safety and efficacy of pirfenidone in patients with mild-to-severe IPF in clinical practice. The clinical records of 76 patients who were diagnosed with IPF and received pirfenidone were reviewed. The most frequent adverse event was anorexia, although the grade of anorexia in most patients was mild. Dose reduction of pirfenidone improved anorexia in 84% affected patients, which resulted in a high medication compliance rate. The mean forced vital capacity (FVC) at the initiation of pirfenidone therapy in this study was approximately 10% lower than that in previous clinical trials. The mean change in FVC during the 6-month period prior to the therapy initiation was -188 mL, which improved to -19 mL during the 6-month period after therapy. Significant attenuation in percentage predicted diffusion capacity of the lung for carbon monoxide decline was also achieved after pirfenidone therapy initiation. The efficacy of pirfenidone in attenuating the degree of FVC decline was higher in the group with FVC decline of ≥150 mL during the 6-month period prior to therapy initiation. The levels of serum markers, such as KL-6 and SP-D, were also lowered by the therapy. These results showed that pirfenidone was well-tolerated and had beneficial effects in patients with mild-to-severe and/or progressive IPF. The degree of disease progression prior to the initiation of pirfenidone therapy had an impact on the response to the therapy. Copyright © 2013 Elsevier Ltd. All rights reserved.

Routine delayed voiding cystourethography after initial successful endoscopic treatment with Dextranomer/Hialuronic Acid Copolimer (Dx/HA) of vesicoureteral reflux (VUR). Is it necessary?

PubMed

García-Aparicio, L; Blázquez-Gómez, E; Vila Santandreu, A; Camacho Diaz, J A; Vila-Cots, J; Ramos Cebrian, M; de Haro, I; Martin, O; Tarrado, X

2016-12-01

Some guidelines recommend an early voiding cystourethrography (VCUG) after endoscopic treatment of vesicoureteral reflux (VUR), but there's no consensus if it's necessary a long-term follow-up in these patients. The aim of our study is analyze if it's necessary a delayed VCUG after initial successful treatment with Dx/HA. We have reviewed all medical charts of patients that underwent Dx/HA treatment from 2006 to 2010. We have selected patients with initial successful treatment and more than 3 years of radiological and clinical follow-up. We have analyzed late clinical and radiological outcomes. One hundred and sixty children with 228 refluxing ureters underwent Dx/HA endoscopic treatment with a mean follow-up of 52.13 months. Early VCUG was performed in 215 ureters with an initial successful rate of 84.1%. The group of study was 94/215 ureters with more than 3 years of follow-up with a delayed VCUG. VUR was still resolved in 79,8% of the ureters. Clinical success rate was 91.7%. The incidence of febrile urinary tract infection in those patients with cured VUR and those with a relapsed VUR was 8 and 15%, respectively; but there were no significant differences. We have not found any variable related with relapsed VUR except those ureters that initially received 2 injections (P<.05). If our objective in the treatment of VUR is to reduce the incidence of febrile urinary tract infection it is not necessary to perform a delayed VCUG even though the long-term radiological outcomes is worse than clinical outcome. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Initiation of non-invasive ventilation in amyotrophic lateral sclerosis and clinical practice guidelines: Single-centre, retrospective, descriptive study in a national reference centre.

PubMed

Georges, Marjolaine; Golmard, Jean-Louis; Llontop, Claudia; Shoukri, Amr; Salachas, François; Similowski, Thomas; Morelot-Panzini, Capucine; Gonzalez-Bermejo, Jésus

2017-02-01

In amyotrophic lateral sclerosis (ALS), respiratory muscle weakness leads to respiratory failure. Non-invasive ventilation (NIV) maintains adequate ventilation in ALS patients. NIV alleviates symptoms and improves survival. In 2006, French guidelines established criteria for NIV initiation based on limited evidence. Their impact on clinical practice remains unknown. Our objective was to describe NIV initiation practices of the main French ALS tertiary referral centre with respect to guidelines. In this retrospective descriptive study, 624 patients followed in a single national reference centre began NIV between 2005 and 2013. We analysed criteria used to initiate NIV, including symptoms, PaCO 2 , forced vital capacity, maximal inspiratory pressures and time spent with SpO 2 <90% at night. At NIV initiation, 90% of patients were symptomatic. Median PaCO 2 was 48 mmHg. The main criterion to initiate NIV was 'symptoms' followed by 'hypercapnia' in 42% and 34% of cases, respectively. NIV was initiated on functional parameters in only 5% of cases. Guidelines were followed in 81% of cases. In conclusion, despite compliance with French guidelines, the majority of patients are treated at the stage of symptomatic daytime hypoventilation, which suggests that NIV is initiated late in the course of ALS. Whether this practice could be improved by changing guidelines or increasing respiratory-dedicated resources remains to be determined.

Anti-NMDA receptor encephalitis: clinical characteristics, predictors of outcome and the knowledge gap in southwest China.

PubMed

Wang, W; Li, J-M; Hu, F-Y; Wang, R; Hong, Z; He, L; Zhou, D

2016-03-01

The aim was to analyse the clinical profiles and outcomes of patients with anti- N-methyl-d-aspartate receptor (anti-NMDAR) encephalitis in China. A retrospective study of anti-NMDAR encephalitis in China was performed between June 2011 and June 2014. The clinical characteristics and predictors of poor outcome were determined. A total of 51 patients with a definitive diagnosis of anti-NMDAR encephalitis were included in this study. Four of them were surgically confirmed to have a neoplasm. Thirty-two patients, amongst whom 24 were female, presented with psychiatric disorder as the initial symptom, whereas 14 patients, of whom nine were male, presented with seizure as the initial symptom (P = 0.011). Twenty-nine patients (56.86%) were initially misdiagnosed with psychosis, viral encephalitis or other diseases, and 58.8% of the patients experienced at least one type of complication. It typically took 3 weeks before these patients were admitted to our hospital and another 2 weeks before the correct diagnosis was made. Forty-one patients (80%) reached a good outcome; 10 patients (20%) had a poor outcome. Older age, extended hospital stay, memory deficits, decreased consciousness, central hypoventilation, complications and abnormal cerebrospinal fluid results were associated with poor outcome (P < 0.05). Female patients more frequently initially present with psychiatric disorder but male patients more frequently initially present with seizure. Patients with anti-NMDAR encephalitis in China have a lower incidence of neoplasm. Nevertheless, this study reveals several challenges in treating anti-NMDAR encephalitis in China that may contribute to poor outcome. © 2015 EAN.

The disparity of frontline clinical staff and managers' perceptions of a quality and patient safety initiative.

PubMed

Parand, Anam; Burnett, Susan; Benn, Jonathan; Pinto, Anna; Iskander, Sandra; Vincent, Charles

2011-12-01

Arguably, a shared perspective between managers and their clinical staff on an improvement initiative would allow for most effective implementation and increase programme success. However, it has been reported that research has failed to differentiate between managers and line employees on quality management implementation and examine their differences in perceptions of quality and safety initiatives. The aim of this study was to compare clinical frontline staff and senior managers' perceptions on the importance of an organization-wide quality and safety collaborative: the Safer Patients Initiative (SPI). A quantitative study obtained 635 surveys at 20 trusts participating in SPI. Participants included the teams and frontline staff involved within the programme at each organization. Independent T-tests were carried out between frontline staff and senior managers' perceptions of SPI programme elements, success factors and impact & sustainability. Statistically significant differences were found between the perceptions of frontline staff and senior managers on a wide number of issues, including the frontline perceiving a significantly larger improvement on the timeliness of care delivery (t = 2.943, P = 0.004), while managers perceived larger improvement on the culture within the organization for safe, effective and reliable care (t = -2.454, P = 0.014). This study has identified statistically significant disparities in perceptions of an organization-wide improvement initiative between frontline staff and senior managers. This holds valuable implications for the importance of getting both frontline and management perspectives when designing such interventions, in monitoring their performance, and in evaluating their impact. © 2010 Blackwell Publishing Ltd.

Organisational support for evidence-based practice: occupational therapists perceptions.

PubMed

Bennett, Sally; Allen, Shelley; Caldwell, Elizabeth; Whitehead, Mary; Turpin, Merrill; Fleming, Jennifer; Cox, Ruth

2016-02-01

Barriers to the use of evidence-based practice extend beyond the individual clinician and often include organisational barriers. Adoption of systematic organisational support for evidence-based practice in health care is integral to its use. This study aimed to explore the perceptions of occupational therapy staff regarding the influence of organisational initiatives to support evidence-based practice on workplace culture and clinical practice. This study used semi-structured interviews with 30 occupational therapists working in a major metropolitan hospital in Brisbane, Australia regarding their perceptions of organisational initiatives designed to support evidence-based practice. Four themes emerged from the data: (i) firmly embedding a culture valuing research and EBP, (ii) aligning professional identity with the Research and Evidence in Practice model, (iii) experiences of change: pride, confidence and pressure and (iv) making evidence-based changes to clinical practices. Organisational initiatives for evidence-based practice were perceived as influencing the culture of the workplace, therapists' sense of identity as clinicians, and as contributing to changes in clinical practice. It is therefore important to consider organisational factors when attempting to increase the use of evidence in practice. © 2016 Occupational Therapy Australia.

Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial.

PubMed

Schwartz, Robert P; Kelly, Sharon M; Mitchell, Shannon G; Dunlap, Laura; Zarkin, Gary A; Sharma, Anjalee; O'Grady, Kevin E; Jaffe, Jerome H

2016-07-01

Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. We describe the background and rationale for the study, its aims, hypotheses, and study design. Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. ClinicalTrials.gov: NCT02334215. Copyright © 2016 Elsevier Inc. All rights reserved.

Did our current initial treatment practice change after EAU/ESPU vesicoureteral reflux risk grouping?

PubMed

Tokat, Eda; Gurocak, Serhat; Ure, Iyimser; Acar, Cenk; Sınık, Zafer; Tan, Mustafa Ozgur

2018-06-02

The "European Association of Urology (EAU) Guidelines on Vesicoureteral Reflux (VUR) in Children (September 2012)" established risk classification by analyzing and defining risk factors for each patient. In this study we aimed to investigate how our initial treatment procedures were affected by EAU/ESPU guideline vesicoureteral reflux risk grouping and to compare the early clinical results of treatments performed before and after the risk classification in our patients with VUR. 334 renal units with regular clinical follow-up who were treated owing to VUR (vesicoureteral reflux) between years 2009 and 2017 were retrospectively reviewed. Preoperative clinical parameters such as grade and laterality of reflux, presence of renal scar, initial and follow-up treatments, findings of medical treatment and surgical procedures were analyzed. The initial medical and surgical methods were compared by categorizing patients according to risk groups before and after 2013. Mean age and follow-up duration were 71.4(6-216) months and 47(4-141) months, respectively. Among the preoperative parameters, only high EAU risk group (p = 0.01) and treating lower urinary tract symptoms (p < 0.001) were determining the postoperative success rates significantly, while age, sex, and presence of renal scar at DMSA were not affecting the success of treatment significantly. While no significant difference in medical and surgical treatment rates is observed after risk grouping system in low risk group, the percentages of patients who are treated with surgical methods initially were significantly decreased in moderate and high risk groups (p = 0.002 and p = 0.012, respectively). We determined that VUR risk grouping did not change clinical success significantly in all risk groups. Despite the fact that EAU/ESPU VUR risk classification changed our current practice in terms of initial treatment method, this different approach did not seem to affect early clinical success positively. There is still an absolute need for studies with larger sample size and long-term follow-up to reach more reliable results. Therapeutic. Level 4. Copyright © 2018 Elsevier Inc. All rights reserved.

The role of alternative and natural agents, cryotherapy, and/or laser for management of alimentary mucositis.

PubMed

Migliorati, Cesar A; Oberle-Edwards, Loree; Schubert, Mark

2006-06-01

To review the literature and update the current guidelines of alternative/natural agents, cryotherapy, and/or laser therapy in the management of alimentary mucositis (AM). The original guidelines developed by the Multinational Association for Supportive Care in Cancer (MASCC)/International Society for Oral Oncology (ISOO) mucositis study group were the basis for this study. A medical librarian conducted an initial Medline search to identify research articles published between 2002 and 2005 in English language. A search term combination that included stomatitis, mucositis, mucous membrane, neoplasm, lasers, complimentary therapies, amino acids, antioxidants, vitamins, minerals, plant extracts, and cryotherapy was conducted. This initial search identified articles with a strong scientific methodology that included both preclinical and clinical research. Using standardized scoring forms, authors reviewed and scored individual articles. A consensus result of the review was achieved in a meeting of reviewers in June of 2005. The initial search identified a total of 167 new articles. Of these, 14 were selected and reviewed: alternative/natural therapy (one preclinical study); cryotherapy (four clinical studies); lasers (two clinical studies); and alternative/natural agents (seven clinical studies). A new guideline could be established for the use of cryotherapy in the management of AM in hematopoietic stem cell transplant (HSCT) patients receiving melphalan in the conditioning phase. The rapid progress in the understanding of AM created a need for new prevention and management protocols. Frequent literature review is now necessary to identify agents and protocols being developed in this important area of supportive care in cancer.

Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin.

PubMed

Karyekar, C S; Frederich, R; Ravichandran, S

2013-08-01

In four 24-week controlled studies, the antihyperglycaemic efficacy of saxagliptin was demonstrated in patients with type 2 diabetes mellitus as add-on therapy to glyburide, a thiazolidinedione, or metformin, and when used in initial combination with metformin vs. metformin monotherapy in drug-naive patients. Data from these studies were analysed to compare the proportions of patients who achieved specific reductions from baseline in glycated haemoglobin [HbA(1c); reductions of ≥ 0.5% and ≥ 0.7% in all studies (prespecified); reductions ≥ 1.0% in the add-on studies and ≥ 1.0% to ≥ 2.5% in the initial combination study (post hoc)] for saxagliptin vs. comparator at week 24. We report overall rates of glycaemic response defined by these reductions in HbA(1c) and rates of response without experiencing hypoglycaemia. Large glycaemic response rates were higher with saxagliptin 2.5 and 5 mg/day than with comparator (HbA(1c) ≥ 1.0%, 31.7-50.3% vs. 10.3-20.0%) as add-on therapy and higher with saxagliptin 5 mg/day as initial combination with metformin than with metformin monotherapy (HbA(1c) ≥ 2.0%, 68.3% vs. 49.8%) in drug-naive patients. Addition of saxagliptin was associated with a low incidence of hypoglycaemia; overall response rates and response rates excluding patients who experienced hypoglycaemia were similar. Analysis of several demographic and baseline clinical variables revealed no consistent correlations with response to saxagliptin. Whether receiving saxagliptin as an add-on therapy to glyburide, a thiazolidinedione, or metformin or in initial combination with metformin, a greater percentage of patients achieve clinically relevant large reductions in HbA(1c) vs. comparator, with a low incidence of hypoglycaemia. © 2013 Bristol-Myers Squibb Co. International Journal of Clinical Practice published by John Wiley & Sons Ltd.

[Clinical management of adrenal incidentalomas: results of a survey].

PubMed

Moreno-Fernández, Jesús; García-Manzanares, Alvaro; Sánchez-Covisa, Miguel Aguirre; García, E Inés Rosa Gómez

2009-12-01

Incidentalomas are clinically silent adrenal masses that are discovered incidentally during diagnostic testing for clinical conditions unrelated to suspicion of adrenal disease. Several decision algorithms are used in the management of adrenal masses. We evaluated the routine use of these algorithms through a clinical activity questionnaire. The questionnaire included data on the work center, initial hormonal and radiological study, imaging and hormonal tests performed to complete the study, surgical indications and clinical follow-up. Thirty-three endocrinologists (79%) attending the annual congress of the Castilla-La Mancha Society of Endocrinology, Nutrition and Diabetes completed the questionnaire. Forty-six percent considered tumoral size to be the most important factor suggesting malignancy in the initial evaluation of adrenal incidentalomas, the limit being 4 cm for 78% of the endocrinologists. Imaging study was completed by magnetic resonance imaging by 39%. All the physicians always performed screening for hypercortisolism and pheochromocytoma. Other assessments always conducted in all incidentalomas included hyperaldosteronism (76%), sex hormone-producing tumor (51%) and congenital adrenal hyperplasia (30%). Seventy-nine percent of respondents began to refer incidentalomas larger than 4 cm for surgical treatment, and 46% referred all tumors larger than 6 cm for surgical treatment. With regard to hormonal function, patients with pheochromocytoma, Cushing's syndrome, hyperaldosteronism with poorly controlled blood pressure or sex hormoneproducing tumors were more frequently referred for surgery. Seventy-six percent of endocrinologists performed clinical follow-up in adrenal incidentalomas larger than 4 cm, preferably through computerized tomography (81%), and repeated studies for hormonal hypercortisolism (97%), primary hyperaldosteronism (42%) and pheochromocytoma (76%) over a 4-5 year period (67%). Clinical practice varied among the endocrinologists surveyed, although a certain uniformity in relation to the main guidelines was observed. A tendency to request a greater number of diagnostic tests for initial hormone assessment and clinical follow-up was detected. Assessment, decision-making and medical monitoring in adrenal incidentalomas remain unclear and consequently further studies are required. Copyright 2009 Sociedad Española de Endocrinología y Nutrición. Published by Elsevier Espana. All rights reserved.

Epilepsy in children with subacute sclerosing panencephalitis.

PubMed

Jović, Nebojša J

2013-01-01

Subacute sclerosing panencephalitis (SSPE) is a rare, progressive, fatal neurodegenerative disease of childhood and early adolescence caused by defective measles virus. The initial symptoms of SSPE usually involve regression in cognitive functioning and behavior or recurrent myoclonic jerks. Seizures revealing SSPE and epilepsy during the clinical course can occur. The aim of the study was to analyze clinical and EEG characteristics of both initially occurred seizures and epilepsy which developed in the course of the disease. Retrospective study was carried out on 19 children (14 boys, 5 girls) with SSPE diagnosed and treated at our Clinic from 1995 to 2010. Seizures revealed SSPE in our patients aged from 6.5 to 11.5 years (mean 8.6 years). SSPE onset ranged from 4.5 to 16.5 years (mean 10.05). Complete vaccination was performed in nine patients. Cognitive and behavioral decline was preceeded by 6-18 months in two children with intractable focal motor seizures with secondary generalization, one child with complex partial seizures and one with atypical absences. During the clinical course of the disease epilepsy developed in 10 (52.6%) cases, including four patients with seizures as the initial SSPE sign. It occurred mainly in the first year, while in three cases seizures appeared between 1 and 5 years of the disease evolution. Myoclonus was present independently from seizures. No significant inter-group differences were found relating to the type of SSPE progression and history of epilepsy. The only child with fulminant SSPE presented with initial seizures. Favorable seizure control was achieved in 60.0% patients. Intractable epilepsy developed in four patients. Atypical SSPE presentation can include mainly focal intractable seizures. Epilepsy developed during clinical course in 52.6% cases. No significant influence was found of the history of epilepsy on the type of SSPE progression.

Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

PubMed

Labhardt, Niklaus Daniel; Ringera, Isaac; Lejone, Thabo Ishmael; Masethothi, Phofu; Thaanyane, T'sepang; Kamele, Mashaete; Gupta, Ravi Shankar; Thin, Kyaw; Cerutti, Bernard; Klimkait, Thomas; Fritz, Christiane; Glass, Tracy Renée

2016-04-14

Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to improve the care cascade in similar settings. NCT02692027 , registered February 21, 2016.

Opportunities for the Cardiovascular Community in the Precision Medicine Initiative.

PubMed

Shah, Svati H; Arnett, Donna; Houser, Steven R; Ginsburg, Geoffrey S; MacRae, Calum; Mital, Seema; Loscalzo, Joseph; Hall, Jennifer L

2016-01-12

The Precision Medicine Initiative recently announced by President Barack Obama seeks to move the field of precision medicine more rapidly into clinical care. Precision medicine revolves around the concept of integrating individual-level data including genomics, biomarkers, lifestyle and other environmental factors, wearable device physiological data, and information from electronic health records to ultimately provide better clinical care to individual patients. The Precision Medicine Initiative as currently structured will primarily fund efforts in cancer genomics with longer-term goals of advancing precision medicine to all areas of health, and will be supported through creation of a 1 million person cohort study across the United States. This focused effort on precision medicine provides scientists, clinicians, and patients within the cardiovascular community an opportunity to work together boldly to advance clinical care; the community needs to be aware and engaged in the process as it progresses. This article provides a framework for potential involvement of the cardiovascular community in the Precision Medicine Initiative, while highlighting significant challenges for its successful implementation. © 2016 American Heart Association, Inc.

Evaluation of the clinical and antimicrobial effects of the Er:YAG laser or topical gaseous ozone as adjuncts to initial periodontal therapy.

PubMed

Yılmaz, Selçuk; Algan, Serdar; Gursoy, Hare; Noyan, Ulku; Kuru, Bahar Eren; Kadir, Tanju

2013-06-01

The aim of this study was to evaluate the clinical and microbiological results of treatment with the Er:YAG laser and topical gaseous ozone application as adjuncts to initial periodontal therapy in chronic periodontitis (CP) patients. Although many studies have evaluated the effectiveness of the Er:YAG laser as an adjunct to initial periodontal therapy, few studies have focused on the use of gaseous ozone as an adjunct. Thirty patients with CP were randomly divided into three parallel groups, each composed of 10 individuals with at least four teeth having at least one approximal site with a probing depth (PD) of ≥5 mm and a sulcus bleeding index (SBI) ≥2 in each quadrant. Groups of patients received: (1) Scaling and root planing (SRP)+Er:YAG laser; (2) SRP+topical gaseous ozone; or (3) SRP alone. The microbiological and clinical parameters were monitored at day 0 and day 90. At the end of the observation period, statistically significant improvements in clinical parameters were observed within each group. Parallel to the clinical changes, all treatments reduced the number of total bacteria and the proportion of obligately anaerobic microorganisms. Although intergroup comparisons of microbiological parameters showed no significant differences, clinical findings, including attachment gain and PD reduction, were found to be statistically significant in favor of the SRP+Er:YAG laser group. Although statistically nonsignificant, the fact that the obligate anaerobic change was mostly observed in the SRP+Er:YAG laser group, and a similar decrease was noted in the SRP+topical gaseous ozone group, shows that ozone has an antimicrobial effect equivalent to that of the Er:YAG laser.

A tracking and verification system implemented in a clinical environment for partial HIPAA compliance

NASA Astrophysics Data System (ADS)

Guo, Bing; Documet, Jorge; Liu, Brent; King, Nelson; Shrestha, Rasu; Wang, Kevin; Huang, H. K.; Grant, Edward G.

2006-03-01

The paper describes the methodology for the clinical design and implementation of a Location Tracking and Verification System (LTVS) that has distinct benefits for the Imaging Department at the Healthcare Consultation Center II (HCCII), an outpatient imaging facility located on the USC Health Science Campus. A novel system for tracking and verification of patients and staff in a clinical environment using wireless and facial biometric technology to monitor and automatically identify patients and staff was developed in order to streamline patient workflow, protect against erroneous examinations and create a security zone to prevent and audit unauthorized access to patient healthcare data under the HIPAA mandate. This paper describes the system design and integration methodology based on initial clinical workflow studies within a clinical environment. An outpatient center was chosen as an initial first step for the development and implementation of this system.

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.

PubMed

Hicks, Karen A; Mahaffey, Kenneth W; Mehran, Roxana; Nissen, Steven E; Wiviott, Stephen D; Dunn, Billy; Solomon, Scott D; Marler, John R; Teerlink, John R; Farb, Andrew; Morrow, David A; Targum, Shari L; Sila, Cathy A; Hai, Mary T Thanh; Jaff, Michael R; Joffe, Hylton V; Cutlip, Donald E; Desai, Akshay S; Lewis, Eldrin F; Gibson, C Michael; Landray, Martin J; Lincoff, A Michael; White, Christopher J; Brooks, Steven S; Rosenfield, Kenneth; Domanski, Michael J; Lansky, Alexandra J; McMurray, John J V; Tcheng, James E; Steinhubl, Steven R; Burton, Paul; Mauri, Laura; O'Connor, Christopher M; Pfeffer, Marc A; Hung, H M James; Stockbridge, Norman L; Chaitman, Bernard R; Temple, Robert J

2018-02-27

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials. © 2018 American Heart Association, Inc.

Clinical predictors of vestibulo-ocular dysfunction in pediatric sports-related concussion.

PubMed

Ellis, Michael J; Cordingley, Dean M; Vis, Sara; Reimer, Karen M; Leiter, Jeff; Russell, Kelly

2017-01-01

OBJECTIVE There were 2 objectives of this study. The first objective was to identify clinical variables associated with vestibulo-ocular dysfunction (VOD) detected at initial consultation among pediatric patients with acute sports-related concussion (SRC) and postconcussion syndrome (PCS). The second objective was to reexamine the prevalence of VOD in this clinical cohort and evaluate the effect of VOD on length of recovery and the development of PCS. METHODS A retrospective review was conducted for all patients with acute SRC and PCS who were evaluated at a pediatric multidisciplinary concussion program from September 2013 to May 2015. Acute SRS was defined as presenting < 30 days postinjury, and PCS was defined according to the International Classification of Diseases, 10th Revision criteria and included being symptomatic 30 days or longer postinjury. The initial assessment included clinical history and physical examination performed by 1 neurosurgeon. Patients were assessed for VOD, defined as the presence of more than 1 subjective vestibular and oculomotor complaint (dizziness, diplopia, blurred vision, etc.) and more than 1 objective physical examination finding (abnormal near point of convergence, smooth pursuits, saccades, or vestibulo-ocular reflex testing). Poisson regression analysis was used to identify factors that increased the risk of VOD at initial presentation and the development of PCS. RESULTS Three hundred ninety-nine children, including 306 patients with acute SRC and 93 with PCS, were included. Of these patients, 30.1% of those with acute SRC (65.0% male, mean age 13.9 years) and 43.0% of those with PCS (41.9% male, mean age 15.4 years) met the criteria for VOD at initial consultation. Independent predictors of VOD at initial consultation included female sex, preinjury history of depression, posttraumatic amnesia, and presence of dizziness, blurred vision, or difficulty focusing at the time of injury. Independent predictors of PCS among patients with acute SRC included the presence of VOD at initial consultation, preinjury history of depression, and posttraumatic amnesia at the time of injury. CONCLUSIONS This study identified important potential risk factors for the development of VOD following pediatric SRC. These results provide confirmatory evidence that VOD at initial consultation is associated with prolonged recovery and is an independent predictor for the development of PCS. Future studies examining clinical prediction rules in pediatric concussion should include VOD. Additional research is needed to elucidate the natural history of VOD following SRC and establish evidence-based indications for targeted vestibular rehabilitation.

[Usefulness of galectin-3 expression in the clinical behavior of differentiated thyroid carcinoma].

PubMed

López Mondéjar, Pedro; Picó, Antonio; Seguí, Javier; López Maciá, Alicia

2008-02-16

Our objective was to quantify the galectin-3 (gal-3) expression in differentiated thyroid carcinoma and study its relation with the clinical behavior of these tumors. We investigated the immunohistochemical reaction of gal-3 in patients with papillary thyroid carcinoma (PTC) and follicular thyroid carcinoma (FTC) and performed a retrospective study in order to find correlations with clinical features. Gal-3 expression was studied in 53 differentiated tyroid carcinomas (42 PTC and 11 FTC), and was related with clinical features: metastases, extrathyroid invasion and initial stage in the diagnosis and persistence disease and relapses in the follow up. Gal-3 expression positivity in PTC had a median of 60% (percentil 25 [p25], 17.5%; percentil 75 [p75], 100%), and was significantly higher (p < 0.0001) than in FTC (median, 0%; p25, 0%; p75, 15%). In PTC, gal-3 expression was significantly higher in advanced stages at the time of initial diagnosis (p = 0.014), persistent disease (p = 0.012) and relapses (p = 0.012) during the follow up. We did not find any significant association between gal-3 expression and clinical features of FTC. Gal-3 is a negative prognosis marker in PTC but not in FTC.

A CIS (Clinical Information System) Quality Evaluation Tool for Nursing Care Services

ERIC Educational Resources Information Center

Lee, Seon Ah

2010-01-01

The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…

Clinical characteristics of patients with type 2 diabetes mellitus at the time of insulin initiation: INSTIGATE observational study in Spain

PubMed Central

Dilla, Tatiana; Reviriego, Jesús; Castell, Conxa; Goday, Albert

2009-01-01

Little information is available on the management of patients with type 2 diabetes mellitus (DM2) in regular clinical practice, prior to and at the point of initiating treatment with insulin. The INSTIGATE study provides a description of the clinical profile of the patient with DM2 who begins treatment with insulin in both primary and secondary care. A total of 224 patients who had been diagnosed with DM2, were not responding to oral treatment, and began receiving insulin were included in the INSTIGATE study in Spain. Demographic data were collected, as well as data on macro- and microvascular complications of diabetes and comorbidities, past medical history of diabetes and oral treatment administered, the clinical severity of diabetes (HbA1c concentration) and insulin treatment initiated. Mean age of the sample was 65.4 years and 56.7% were men. There were 87% of patients who had a diagnosis of at least one significant comorbidity, notably hypertension and hyperlipidemia. The patient profile for metabolic syndrome was met by 75.1% of the patients. There was a higher incidence of macrovascular complications (38.4%) than microvascular complications (16.1%). Prior to insulin initiation, the most recent mean HbA1c was 9.2%. The majority of patients had been treated in the last 12 months with sulfonylureas and/or metformin (69.6 and 57.6%). The most common treatment prior to insulinization was the co-administration of two oral antidiabetics (OADs) (37.5%). Patients with DM2 observed in the study presented with elevated mean HbA1c and body mass index levels, comorbidities and complications related to diabetes at the time of insulin initiation. Changes and adjustments in treatment from diagnosis of diabetes occur when HbA1c levels are far above those recommended by the IDF (International Diabetes Federation), a factor which could be contributing to the development of both macrovascular and microvascular complications in the patient profile described in the study. PMID:19855919

Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial.

PubMed

MacArthur, Christine; Jolly, Kate; Ingram, Lucy; Freemantle, Nick; Dennis, Cindy-Lee; Hamburger, Ros; Brown, Julia; Chambers, Jackie; Khan, Khalid

2009-01-30

To assess the effectiveness of an antenatal service using community based breastfeeding peer support workers on initiation of breast feeding. Cluster randomised controlled trial. Community antenatal clinics in one primary care trust in a multiethnic, deprived population. 66 antenatal clinics with 2511 pregnant women: 33 clinics including 1140 women were randomised to receive the peer support worker service and 33 clinics including 1371 women were randomised to receive standard care. An antenatal peer support worker service planned to comprise a minimum of two contacts with women to provide advice, information, and support from approximately 24 weeks' gestation within the antenatal clinic or at home. The trained peer support workers were of similar ethnic and sociodemographic backgrounds to their clinic population. Initiation of breast feeding obtained from computerised maternity records of the hospitals where women from the primary care trust delivered. The sample was multiethnic, with only 9.4% of women being white British, and 70% were in the lowest 10th for deprivation. Most of the contacts with peer support workers took place in the antenatal clinics. Data on initiation of breast feeding were obtained for 2398 of 2511 (95.5%) women (1083/1140 intervention and 1315/1371 controls). The groups did not differ for initiation of breast feeding: 69.0% (747/1083) in the intervention group and 68.1% (896/1315) in the control groups; cluster adjusted odds ratio 1.11 (95% confidence interval 0.87 to 1.43). Ethnicity, parity, and mode of delivery independently predicted initiation of breast feeding, but randomisation to the peer support worker service did not. A universal service for initiation of breast feeding using peer support workers provided within antenatal clinics serving a multiethnic, deprived population was ineffective in increasing initiation rates. Current Controlled Trials ISRCTN16126175.

A retrospective explanatory case study of the implementation of a bleeding management quality initiative, in an Australian cardiac surgery unit.

PubMed

Pearse, Bronwyn Louise; Rickard, Claire M; Keogh, Samantha; Lin Fung, Yoke

2018-03-09

Bleeding management in cardiac surgery is challenging. Many guidelines exist to support bleeding management; however, literature demonstrates wide variation in practice. In 2012, a quality initiative was undertaken at The Prince Charles Hospital, Australia to improve bleeding management for cardiac surgery patients. The implementation of the quality initiative resulted in significant reductions in the incidence of blood transfusion, re-exploration for bleeding; superficial leg and chest wound infections; length of hospital stay, and cost. Given the success of the initiative, we sought to answer the question; "How and why was the process of implementing a bleeding management quality initiative in the cardiac surgery unit successful, and sustainable?" A retrospective explanatory case study design was chosen to explore the quality initiative. Analysis of the evidence was reviewed through phases of the 'Knowledgeto Action' planned change model. Data was derived from: (1) document analysis, (2) direct observation of the local environment, (3) clinical narratives from interviews, and analysed with a triangulation approach. The study period extended from 10/2011 to 6/2013. Results demonstrated the complexity of changing practice, as well as the significant amount of dedicated time and effort required to support individual, department and system wide change. Results suggest that while many clinicians were aware of the potential to apply improved practice, numerous barriers and challenges needed to be overcome to implement change across multiple disciplines and departments. The key successful components of the QI were revealed through the case study analysis as: (1) an appropriately skilled project manager to facilitate the implementation process; (2) tools to support changes in workflow and decision making including a bleeding management treatment algorithm with POCCTs; (3) strong clinical leadership from the multidisciplinary team and; (4) the evolution of the project manager position into a perpetual clinical position to support sustainability. Copyright © 2018 Australian College of Critical Care Nurses Ltd. All rights reserved.

Automatic initialization and quality control of large-scale cardiac MRI segmentations.

PubMed

Albà, Xènia; Lekadir, Karim; Pereañez, Marco; Medrano-Gracia, Pau; Young, Alistair A; Frangi, Alejandro F

2018-01-01

Continuous advances in imaging technologies enable ever more comprehensive phenotyping of human anatomy and physiology. Concomitant reduction of imaging costs has resulted in widespread use of imaging in large clinical trials and population imaging studies. Magnetic Resonance Imaging (MRI), in particular, offers one-stop-shop multidimensional biomarkers of cardiovascular physiology and pathology. A wide range of analysis methods offer sophisticated cardiac image assessment and quantification for clinical and research studies. However, most methods have only been evaluated on relatively small databases often not accessible for open and fair benchmarking. Consequently, published performance indices are not directly comparable across studies and their translation and scalability to large clinical trials or population imaging cohorts is uncertain. Most existing techniques still rely on considerable manual intervention for the initialization and quality control of the segmentation process, becoming prohibitive when dealing with thousands of images. The contributions of this paper are three-fold. First, we propose a fully automatic method for initializing cardiac MRI segmentation, by using image features and random forests regression to predict an initial position of the heart and key anatomical landmarks in an MRI volume. In processing a full imaging database, the technique predicts the optimal corrective displacements and positions in relation to the initial rough intersections of the long and short axis images. Second, we introduce for the first time a quality control measure capable of identifying incorrect cardiac segmentations with no visual assessment. The method uses statistical, pattern and fractal descriptors in a random forest classifier to detect failures to be corrected or removed from subsequent statistical analysis. Finally, we validate these new techniques within a full pipeline for cardiac segmentation applicable to large-scale cardiac MRI databases. The results obtained based on over 1200 cases from the Cardiac Atlas Project show the promise of fully automatic initialization and quality control for population studies. Copyright © 2017 Elsevier B.V. All rights reserved.

Effectiveness of a Psychoeducational Parenting Group on Child, Parent and Family Behavior: A Pilot Study in a Family Practice Clinic with an Underserved Population

PubMed Central

Berge, Jerica M.; Law, David D.; Johnson, Jennifer; Wells, M. Gawain

2013-01-01

Background Although integrated care for adults in primary care has steadily increased over the last several decades, there remains a paucity of research regarding integrated care for children in primary care. Purpose To report results of a pilot study testing initial feasibility of a parenting psychoeducational group targeting child behavioral problems within a primary care clinic. Method The participants (n = 35) were parents representing an underserved population from an inner-city primary care clinic. Participants attended a 12-week psychoeducational parenting group and reported pre- and post-measures of family functioning, child misbehavior and dyadic functioning. Paired t-tests and effects sizes are reported. Results Participants reported statistically significant improvement in family functioning, child misbehavior and couple functioning after participating in the parenting psychoeducational group. Conclusions Results suggest initial feasibility of a parenting psychoeducational group within a primary care clinic with an underserved population. This intervention may be useful for other primary care clinics seeking to offer more integrative care options for children and their families. PMID:20939627

Retention in care, resource utilization, and costs for adults receiving antiretroviral therapy in Zambia: a retrospective cohort study

PubMed Central

2014-01-01

Background Of the estimated 800,000 adults living with HIV in Zambia in 2011, roughly half were receiving antiretroviral therapy (ART). As treatment scale up continues, information on the care provided to patients after initiating ART can help guide decision-making. We estimated retention in care, the quantity of resources utilized, and costs for a retrospective cohort of adults initiating ART under routine clinical conditions in Zambia. Methods Data on resource utilization (antiretroviral [ARV] and non-ARV drugs, laboratory tests, outpatient clinic visits, and fixed resources) and retention in care were extracted from medical records for 846 patients who initiated ART at ≥15 years of age at six treatment sites between July 2007 and October 2008. Unit costs were estimated from the provider’s perspective using site- and country-level data and are reported in 2011 USD. Results Patients initiated ART at a median CD4 cell count of 145 cells/μL. Fifty-nine percent of patients initiated on a tenofovir-containing regimen, ranging from 15% to 86% depending on site. One year after ART initiation, 75% of patients were retained in care. The average cost per patient retained in care one year after ART initiation was $243 (95% CI, $194-$293), ranging from $184 (95% CI, $172-$195) to $304 (95% CI, $290-$319) depending on site. Patients retained in care one year after ART initiation received, on average, 11.4 months’ worth of ARV drugs, 1.5 CD4 tests, 1.3 blood chemistry tests, 1.4 full blood count tests, and 6.5 clinic visits with a doctor or clinical officer. At all sites, ARV drugs were the largest cost component, ranging from 38% to 84% of total costs, depending on site. Conclusions Patients initiate ART late in the course of disease progression and a large proportion drop out of care after initiation. The quantity of resources utilized and costs vary widely by site, and patients utilize a different mix of resources under routine clinical conditions than if they were receiving fully guideline-concordant care. Improving retention in care and guideline concordance, including increasing the use of tenofovir in first-line ART regimens, may lead to increases in overall treatment costs. PMID:24684772

[Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

PubMed

Benninger-Döring, G; Boos, J

2006-07-01

Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.

77 FR 71211 - Request for Information: Establish a Public-Private Collaboration, “Drug Development Initiative...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

... clinical trials with the support of the VA Cooperative Studies Program. To identify and test new drug..., ``Drug Development Initiative'' (DDI), for New Pharmacological Treatments for Post-Traumatic Stress... will delineate the collaboration for PTSD treatment intended to test new drugs to benefit Veterans...

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

PubMed

Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

2015-10-01

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

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

PubMed Central

2014-01-01

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

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

PubMed Central

2014-01-01

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

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

PubMed Central

2014-01-01

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

The first interview: Anxieties and research on initiating psychoanalysis.

PubMed

Reith, Bernard

2015-06-01

A qualitative clinical study of preliminary interviews by the Working Party on Initiating Psychoanalysis (WPIP) of the European Psychoanalytic Federation suggests that the unconscious dynamics in first interviews are extraordinarily powerful and that they give rise to deep unconscious anxieties in both patient and analyst, with the corresponding defences against them. Furthermore, the group dynamics observed in the clinical workshops and in the research team doing the study suggest that both the anxieties and the defences are conveyed to these groups in the form of unelaborated 'session residues' provoking renewed anxieties and defences in them. These findings contribute to our understanding of what goes on in first interviews, but also raise interesting questions about the psychoanalytic research process in psychoanalysis and how confrontation with the unknown is dealt with in that context. Rather than as a means to avoid anxiety, method in clinical research can be seen as a way to help the research group to contain its reactions and to tolerate them until the group finds its way to further elaboration. These points are illustrated with a clinical case drawn from the study. Copyright © 2014 Institute of Psychoanalysis.

Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials.

PubMed

Mitchell, P; Korobelnik, J-F; Lanzetta, P; Holz, F G; Prünte, C; Schmidt-Erfurth, U; Tano, Y; Wolf, S

2010-01-01

Neovascular age-related macular degeneration (AMD) has a poor prognosis if left untreated, frequently resulting in legal blindness. Ranibizumab is approved for treating neovascular AMD. However, further guidance is needed to assist ophthalmologists in clinical practice to optimise treatment outcomes. An international retina expert panel assessed evidence available from prospective, multicentre studies evaluating different ranibizumab treatment schedules (ANCHOR, MARINA, PIER, SAILOR, SUSTAIN and EXCITE) and a literature search to generate evidence-based and consensus recommendations for treatment indication and assessment, retreatment and monitoring. Ranibizumab is indicated for choroidal neovascular lesions with active disease, the clinical parameters of which are outlined. Treatment initiation with three consecutive monthly injections, followed by continued monthly injections, has provided the best visual-acuity outcomes in pivotal clinical trials. If continued monthly injections are not feasible after initiation, a flexible strategy appears viable, with monthly monitoring of lesion activity recommended. Initiation regimens of fewer than three injections have not been assessed. Continuous careful monitoring with flexible retreatment may help avoid vision loss recurring. Standardised biomarkers need to be determined. Evidence-based guidelines will help to optimise treatment outcomes with ranibizumab in neovascular AMD.

Problems and challenges of nursing students’ clinical evaluation: A qualitative study

PubMed Central

Rafiee, Ghazanfar; Moattari, Marzieh; Nikbakht, Alireza N; Kojuri, Javad; Mousavinasab, Masoud

2014-01-01

Background: The purpose of this qualitative exploratory study was to explore the views of nursing trainers and students about nursing students’ clinical evaluation problems and drawbacks in Shiraz Nursing and Midwifery School. Materials and Methods: A qualitative exploratory approach was used in this study at Shiraz Nursing and Midwifery School in 2012. A purposeful sample of 8 nursing instructors and 40 nursing students was interviewed and the data on their opinions about the problems of the clinical evaluation were collected through semi-structured deep interviews. Initially, four open-ended questions, which were related to the clinical evaluation status, problems, were used to stimulate discussions in the interview sessions. Content analysis was employed in order to analyze the transcribed data. The recorded interviews were initially transcribed, read, and reread on a number of occasions to get an overall feeling of what the participants were saying. Each line or incident was described, and then a code, which reflected the essence of the participants’ comments, was given. Results: The codes were compared for similarity and differences, merged together, and categorized. Finally, five themes emerged: In appropriate clinical evaluation method, problems of clinical evaluation Process, problems related to clinical instructors, unsuitable programming of clinical education, and organizational shortcomings. Conclusion: Besides focusing on upgrading the current clinical evaluation forms, nursing trainers should improve their knowledge about a complete and comprehensive clinical evaluation. They should also apply other appropriate and objective clinical evaluation methods and tools, and perform a formative and summative clinical evaluation. Also, workload adjustment of the nursing trainers needs revision. Therefore, despite using traditional and sometimes limited evaluation methods for assessing nursing students, a co mprehensive and appropriate evaluation of nursing students’ clinical competencies seems necessary. PMID:24554959

Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system.

PubMed

Kroenke, Candyce H; Hershman, Dawn L; Gomez, Scarlett L; Adams, Sara R; Eldridge, Elizabeth H; Kwan, Marilyn L; Ergas, Isaac J; Kubo, Ai; Kushi, Lawrence H

2018-04-18

We evaluated associations between personal and clinical social support and non-adherence to adjuvant endocrine therapy (AET) in a large, Northern California breast cancer (BC) cohort from an integrated healthcare network. This study included 3382 women from the Pathways Study diagnosed from 2005 to 2013 with stages I-III hormone receptor-positive BC and who responded to the Medical Outcomes Study Social Support and Interpersonal Processes of Care surveys, approximately 2 months post-diagnosis. We used logistic regression to evaluate associations between tertiles of social support and non-initiation (< 2 consecutive prescription fills within a year after diagnosis). Among those who initiated treatment, we used proportional hazards regression to evaluate associations with discontinuation (≥ 90 day gap) and non-adherence (< 80% medical possession ratio). Of those who initiated AET (79%), approximately one-fourth either discontinued AET or were non-adherent. AET non-initiation was more likely in women with moderate (adjusted OR 1.18, 95% CI 0.96-1.46) or low (OR 1.30, 95% CI 1.05-1.62) versus high personal social support (P trend = 0.02). Women with moderate (HR 1.20, 95% CI 0.99-1.45) or low (HR 1.32, 95% CI 1.09-1.60) personal social support were also more likely to discontinue treatment (P trend = 0.01). Furthermore, women with moderate (HR 1.25, 95% CI 1.02-1.53) or low (HR 1.38, 95% CI 1.12-1.70) personal social support had higher non-adherence (P trend = 0.007). Associations with clinical social support and outcomes were similar. Notably, high clinical social support mitigated the risk of discontinuation when patients' personal support was moderate or low (P value = 0.04). Women with low personal or clinical social support had higher AET non-adherence. Clinician teams may need to fill support gaps that compromise treatment adherence.

Common Data Elements for Clinical Research in Friedreich Ataxia

PubMed Central

Lynch, David R.; Pandolfo, Massimo; Schulz, Jorg B.; Perlman, Susan; Delatycki, Martin B.; Payne, R. Mark; Shaddy, Robert; Fischbeck, Kenneth H.; Farmer, Jennifer; Kantor, Paul; Raman, Subha V.; Hunegs, Lisa; Odenkirchen, Joanne; Miller, Kristy; Kaufmann, Petra

2012-01-01

Background To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich ataxia, a neurological disorder that involves multiple organ systems. Methods To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: Ataxia and Performance Measures; Biomarkers; Cardiac and Other Clinical Outcomes; and Demographics, Laboratory Tests and Medical History. The basic development process included: Identification of international experts in Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment. Results The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The Subgroups’ recommendations are classified as core, supplemental or exploratory. Template case report forms were created for many of the core tests. Conclusions The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia. PMID:23239403

Precision Medicine in Gastrointestinal Pathology.

PubMed

Wang, David H; Park, Jason Y

2016-05-01

-Precision medicine is the promise of individualized therapy and management of patients based on their personal biology. There are now multiple global initiatives to perform whole-genome sequencing on millions of individuals. In the United States, an early program was the Million Veteran Program, and a more recent proposal in 2015 by the president of the United States is the Precision Medicine Initiative. To implement precision medicine in routine oncology care, genetic variants present in tumors need to be matched with effective clinical therapeutics. When we focus on the current state of precision medicine for gastrointestinal malignancies, it becomes apparent that there is a mixed history of success and failure. -To present the current state of precision medicine using gastrointestinal oncology as a model. We will present currently available targeted therapeutics, promising new findings in clinical genomic oncology, remaining quality issues in genomic testing, and emerging oncology clinical trial designs. -Review of the literature including clinical genomic studies on gastrointestinal malignancies, clinical oncology trials on therapeutics targeted to molecular alterations, and emerging clinical oncology study designs. -Translating our ability to sequence thousands of genes into meaningful improvements in patient survival will be the challenge for the next decade.

Operational and Clinical Strategies to Address Drug Cost Containment in the Acute Care Setting.

PubMed

McConnell, Karen J; Guzman, Oscar E; Pherwani, Nisha; Spencer, Dustin D; Van Cura, Jennifer D; Shea, Katherine M

2017-01-01

To provide clinical and operational strategies to generate drug cost savings in the hospital setting. A search of the PubMed database was performed with no time limit through July 2016. All original prospective and retrospective studies, peer-reviewed guidelines, consensus statements, review articles, and accompanying references were evaluated for inclusion. Only articles published in the English language were included. Investigators reviewed 937 abstracts. The review of the literature showed that acute care hospitals are under increasing financial pressures, and the pharmacy is often responsible for opportunities to manage drug costs. The literature also indicated that cost-containment strategies in the acute care setting range from pharmacy-directed activities to initiatives requiring interdisciplinary collaboration and strategic planning. Hospital pharmacies should consider establishing an interdisciplinary team that is responsible for systematically reviewing drug cost implications and leading any initiatives that are deemed necessary. Acute care settings can use various operational and clinical strategies to lower their expenditures on high-cost drugs. Operational strategies include various activities that pharmacy staff implement related to contracting, purchasing, and inventory management. Clinical strategies utilize clinical pharmacists working with interdisciplinary teams to develop and maintain a formulary, implement established-use criteria for select drugs, use dose optimization, and implement other clinical tactics aimed at cost containment. After initiatives are implemented, assessing the outcomes of the initiatives is important to determine how successful they were at lowering costs safely and effectively. Acute care hospitals can use various operational and clinical strategies to lower overall drug costs. A systematic stepwise approach is recommended to ensure relevant drugs are regularly reviewed and addressed as needed. © 2016 Pharmacotherapy Publications, Inc.

Cognitive training in Alzheimer's disease: a controlled randomized study.

PubMed

Giovagnoli, A R; Manfredi, V; Parente, A; Schifano, L; Oliveri, S; Avanzini, G

2017-08-01

This controlled randomized single-blind study evaluated the effects of cognitive training (CT), compared to active music therapy (AMT) and neuroeducation (NE), on initiative in patients with mild to moderate Alzheimer's disease (AD). Secondarily, we explored the effects of CT on episodic memory, mood, and social relationships. Thirty-nine AD patients were randomly assigned to CT, AMT, or NE. Each treatment lasted 3 months. Before, at the end, and 3 months after treatment, neuropsychological tests and self-rated scales assessed initiative, episodic memory, depression, anxiety, and social relationships. At the end of the CT, initiative significantly improved, whereas, at the end of AMT and NE, it was unchanged. Episodic memory showed no changes at the end of CT or AMT and a worsening after NE. The rates of the patients with clinically significant improvement of initiative were greater after CT (about 62%) than after AMT (about 8%) or NE (none). At the 3-month follow-up, initiative and episodic memory declined in all patients. Mood and social relationships improved in the three groups, with greater changes after AMT or NE. In patients with mild to moderate AD, CT can improve initiative and stabilize memory, while the non-cognitive treatments can ameliorate the psychosocial aspects. The combining of CT and non-cognitive treatments may have useful clinical implications.

Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis.

PubMed

Fleischmann, Roy; Wollenhaupt, Jürgen; Cohen, Stanley; Wang, Lisy; Fan, Haiyun; Bandi, Vara; Andrews, John; Takiya, Liza; Bananis, Eustratios; Weinblatt, Michael E

2018-06-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the effect of concomitant methotrexate (MTX) or glucocorticoid (GC) use on tofacitinib clinical efficacy. Data were pooled from two open-label, long-term extension studies of tofacitinib 5 or 10 mg twice daily in patients with RA. Response according to Clinical Disease Activity Index (CDAI) was assessed separately in patients who discontinued (no MTX/GC use within 30 days prior to year-3 visit; assessment at month 3/year 3) or initiated (on/before year 3; assessment at initiation and year 3) MTX/GC. By year 3, among patients receiving background MTX at baseline, 186/1608 (11.6%) discontinued MTX, and 319/1434 (22.2%) patients receiving GC at baseline discontinued GC. Overall, 70.4/69.1% of patients who discontinued/continued MTX and 72.7/65.9% who discontinued/continued GC achieved CDAI remission or low disease activity (LDA) at year 3. Month 3 remission/LDA rates were maintained at year 3 in the majority of patients, irrespective of MTX/GC discontinuation/continuation. By year 3, 6.2% of patients receiving tofacitinib without MTX at baseline had initiated concomitant MTX, and 25.1% receiving tofacitinib without GC initiated GC; 69.0% and 45.4% initiating MTX or GC, respectively, had a CDAI-defined incomplete response prior to initiation. RA signs/symptoms improved following MTX initiation; only modest improvement was observed with GC initiation. Patients achieving remission/LDA with tofacitinib may discontinue MTX or GC and maintain treatment response. Patients with an incomplete response may benefit from adding concomitant MTX. Pfizer Inc. Study A3921024 [NCT00413699] and Study A3921041 [NCT00661661].

A combination SMS and transportation reimbursement intervention to improve HIV care following abnormal CD4 test results in rural Uganda: a prospective observational cohort study.

PubMed

Siedner, Mark J; Santorino, Data; Lankowski, Alexander J; Kanyesigye, Michael; Bwana, Mwebesa B; Haberer, Jessica E; Bangsberg, David R

2015-07-06

Up to 50 % of HIV-infected persons in sub-Saharan Africa are lost from care between HIV diagnosis and antiretroviral therapy (ART) initiation. Structural barriers, including cost of transportation to clinic and poor communication systems, are major contributors. We conducted a prospective, pragmatic, before-and-after clinical trial to evaluate a combination mobile health and transportation reimbursement intervention to improve care at a publicly operated HIV clinic in Uganda. Patients undergoing CD4 count testing were enrolled, and clinicians selected a result threshold that would prompt early return for ART initiation or further care. Participants enrolled in the pre-intervention period (January - August 2012) served as a control group. Participants in the intervention period (September 2012 - November 2013) were randomized to receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading "ABCDEFG" to confidentially convey an abnormal result. Participants returning within seven days of their first message received transportation reimbursements (about $6USD). Our primary outcomes of interest were time to return to clinic and time to ART initiation. There were 45 participants in the pre-intervention period and 138 participants in the intervention period (46, 49, and 43 in the direct, PIN, and coded groups, respectively) with low CD4 count results. Median time to clinic return was 33 days (IQR 11-49) in the pre-intervention period and 6 days (IQR 3-16) in the intervention period (P < 0.001); and median time to ART initiation was 47 days (IQR 11-75) versus 12 days (IQR 5-19), (P < 0.001). In multivariable models, participants in the intervention period had earlier return to clinic (AHR 2.32, 95 %CI 1.53 to 3.51) and earlier time to ART initiation (AHR 2.27, 95 %CI 1.38 to 3.72). All three randomized message formats improved time to return to clinic and time to ART initiation (P < 0.01 for all comparisons versus the pre-intervention period). A combination of an SMS laboratory result communication system and transportation reimbursements significantly decreased time to clinic return and time to ART initiation after abnormal CD4 test results. Clinicaltrials.gov NCT01579214 , approved 13 April 2012.

Impact of WHO 2010 Guidelines on Antiretroviral Therapy Initiation among Patients with HIV-Associated Tuberculosis in Clinics with and without Onsite HIV Services in the Democratic Republic of Congo

PubMed Central

Tabala, Martine; Batumbula, Marie Louise; Wenzi, Landry; Basaki, Emmanuel; Mungoyo, Eugenie; Mangala, Richard; Behets, Frieda

2016-01-01

Background. We assessed the impact of WHO's 2010 guidelines that removed the requirement of CD4 count before ART, on timely initiation of ART among HIV/TB patients in the Democratic Republic of Congo (DRC). Methods. Data collected to monitor implementation of provider initiated HIV testing and counseling (PITC) and linkage to HIV care from 65 and 13 TB clinics in Kinshasa and Kisangani, respectively, between November 2010 and June 2013. Results. Prior to the WHO's 2010 guidelines, in Kinshasa, 79.1% (401/507) of HIV/TB patients referred for HIV services were initiated on ART in clinics with onsite ART services compared to 50.0% (63/123) in clinics without. Following the implementation of the new guidelines, 89.8% (714/795) and 93.0% (345/371) of HIV/TB patients referred for HIV services were initiated on ART, respectively, in clinics with onsite and without onsite ART services. Similarly, in Kisangani, 69.7% (53/120) and 36.4% (16/44) in clinics with and without onsite ART service, respectively, were initiated on ART prior to the 2010 guidelines and 88.8% (135/152) and 72.6% (106/146), respectively, after the new guidelines. Conclusion. Though implementation of the 2010 guidelines increased the proportion of HIV/TB patients initiated on ART substantially, it remained below the 100% target, particularly in clinics without onsite ART services. PMID:27595020

Computed Tomography Angiography in Patients Evaluated for Acute Pulmonary Embolism with Low Serum D-dimer Levels: A Prospective Study.

PubMed

Gimber, Lana Hirai; Travis, R Ing; Takahashi, Jayme M; Goodman, Torrey L; Yoon, Hyo-Chun

2009-01-01

Pulmonary computed tomography angiography (CTA) and the Wells criteria both have interobserver variability in the assessment of pulmonary embolism (PE). Quantitative D-dimer assay findings have been shown to have a high negative predictive value in patients with low pretest probability of PE. Evaluate roles for clinical probability and CTA in Emergency Department (ED) patients suspected of acute PE but having a low serum D-dimer level. Prospective observational study of ED patients with possible PE who underwent pulmonary CTA and had D-dimer levels

Meteorological factors and timing of the initiating event of human parturition

NASA Astrophysics Data System (ADS)

Hirsch, Emmet; Lim, Courtney; Dobrez, Deborah; Adams, Marci G.; Noble, William

2011-03-01

The aim of this study was to determine whether meteorological factors are associated with the timing of either onset of labor with intact membranes or rupture of membranes prior to labor—together referred to as `the initiating event' of parturition. All patients delivering at Evanston Hospital after spontaneous labor or rupture of membranes at ≥20 weeks of gestation over a 6-month period were studied. Logistic regression models of the initiating event of parturition using clinical variables (maternal age, gestational age, parity, multiple gestation and intrauterine infection) with and without the addition of meteorological variables (barometric pressure, temperature and humidity) were compared. A total of 1,088 patients met the inclusion criteria. Gestational age, multiple gestation and chorioamnionitis were associated with timing of initiation of parturition ( P < 0.01). The addition of meteorological to clinical variables generated a statistically significant improvement in prediction of the initiating event; however, the magnitude of this improvement was small (less than 2% difference in receiver-operating characteristic score). These observations held regardless of parity, fetal number and gestational age. Meteorological factors are associated with the timing of parturition, but the magnitude of this association is small.

Nonspecific abdominal pain is a safe diagnosis.

PubMed

Pennel, David John Laurie; Goergen, Nina; Driver, Chris P

2014-11-01

The aim of this study is to assess if a clinical diagnosis of nonspecific abdominal pain (NSAP) is safe and if patients with this initial diagnosis are likely to require further investigation or surgical intervention. 3323 patients admitted with NSAP from July 1990 to September 2012 utilizing a prospective database of all surgical admissions were included. Readmission over the period of the study and specifically within 30 days of their initial presentation was identified together with any invasive investigation or surgical intervention. 319 children (9.6%) were subsequently readmitted with abdominal pain at some point during the study period. Of these, 78 (2.3%) were readmitted within 30 days. 118 (3.5%) children subsequently had an operation or invasive investigation some point following their initial admission. Of these 33 (0.6%) had the procedure within 3 months of the initial admission. 13 patients had an appendicectomy within 3 months of the initial presentation. Of these histology confirmed appendicitis in 8 patients. This gives an overall incidence of "missed" appendicitis of 0.2 % (8/3323). This study confirms that a clinical diagnosis of nonspecific abdominal pain (NSAP) is safe in a pediatric population and the risk of "missing" appendicitis is only 0.2%. Patients and/or parents can be confidently reassured that the risk of missing organic pathology is very low. Copyright © 2014 Elsevier Inc. All rights reserved.

Comparison of anchorage loss following initial leveling and aligning using ROTH and MBT Prescription - A clinical prospective study.

PubMed

Rajesh, M; Kishore, Msv; Shetty, K Sadashiva

2014-04-01

To evaluate the amount and percentage of anchor loss after initial leveling and aligning using a ROTH and MBT prescription. Pre and post alignment lateral cephalograms & dental casts of 10 ROTH & 10 MBT patients. In the study, it was found that the amount of anchor loss is greater in the ROTH group than the MBT group. This could be due to the increased anterior tip in the ROTH prescription, compared to MBT. The total anterior tip in ROTH is 270 and in MBT is 200. The additional tip of 70 in ROTH prescription itself would have resulted in forward thrust of the anteriors. The use of laceback and cinchbacks creates a statistically and clinically significant increase in the anchorage loss specifically when the posterior anchorage is not enhanced. In this study TPA was not used but studies have shown that passive TPA has almost no effect on the clinician's need to preserve anchorage in the correction of malocclusion. On the other hand, the TPA is an excellent way to prevent molar rotation and maintain the original vertical and transverse dimension when desired. How to cite the article: Rajesh M, Kishore MS, Shetty KS. Comparison of anchorage loss following initial leveling and aligning using ROTH and MBT Prescription - A clinical prospective study. J Int Oral Health 2014;6(2):16-21.

Comparison of anchorage loss following initial leveling and aligning using ROTH and MBT Prescription – A clinical prospective study

PubMed Central

Rajesh, M; Kishore, MSV; Shetty, K Sadashiva

2014-01-01

Background: To evaluate the amount and percentage of anchor loss after initial leveling and aligning using a ROTH and MBT prescription. Materials & Methods: Pre and post alignment lateral cephalograms & dental casts of 10 ROTH & 10 MBT patients. Results: In the study, it was found that the amount of anchor loss is greater in the ROTH group than the MBT group. This could be due to the increased anterior tip in the ROTH prescription, compared to MBT. The total anterior tip in ROTH is 270 and in MBT is 200. The additional tip of 70 in ROTH prescription itself would have resulted in forward thrust of the anteriors. Conclusion: The use of laceback and cinchbacks creates a statistically and clinically significant increase in the anchorage loss specifically when the posterior anchorage is not enhanced. In this study TPA was not used but studies have shown that passive TPA has almost no effect on the clinician's need to preserve anchorage in the correction of malocclusion. On the other hand, the TPA is an excellent way to prevent molar rotation and maintain the original vertical and transverse dimension when desired. How to cite the article: Rajesh M, Kishore MS, Shetty KS. Comparison of anchorage loss following initial leveling and aligning using ROTH and MBT Prescription – A clinical prospective study. J Int Oral Health 2014;6(2):16-21. PMID:24876697

Initial use of echinocandins does not negatively influence outcome in Candida parapsilosis bloodstream infection: a propensity score analysis.

PubMed

Fernández-Ruiz, Mario; Aguado, José María; Almirante, Benito; Lora-Pablos, David; Padilla, Belén; Puig-Asensio, Mireia; Montejo, Miguel; García-Rodríguez, Julio; Pemán, Javier; Ruiz Pérez de Pipaón, Maite; Cuenca-Estrella, Manuel

2014-05-01

Concerns have arisen regarding the optimal antifungal regimen for Candida parapsilosis bloodstream infection (BSI) in view of its reduced susceptibility to echinocandins. The Prospective Population Study on Candidemia in Spain (CANDIPOP) is a prospective multicenter, population-based surveillance program on Candida BSI conducted through a 12-month period in 29 Spanish hospitals. Clinical isolates were identified by DNA sequencing, and antifungal susceptibility testing was performed by the European Committee on Antimicrobial Susceptibility Testing methodology. Predictors for clinical failure (all-cause mortality between days 3 to 30, or persistent candidemia for ≥72 hours after initiation of therapy) in episodes of C. parapsilosis species complex BSI were assessed by logistic regression analysis. We further analyzed the impact of echinocandin-based regimen as the initial antifungal therapy (within the first 72 hours) by using a propensity score approach. Among 752 episodes of Candida BSI identified, 200 (26.6%) were due to C. parapsilosis species complex. We finally analyzed 194 episodes occurring in 190 patients. Clinical failure occurred in 58 of 177 (32.8%) of evaluable episodes. Orotracheal intubation (adjusted odds ratio [AOR], 2.81; P = .018) and septic shock (AOR, 2.91; P = .081) emerged as risk factors for clinical failure, whereas early central venous catheter removal was protective (AOR, 0.43; P = .040). Neither univariate nor multivariate analysis revealed that the initial use of an echinocandin-based regimen had any impact on the risk of clinical failure. Incorporation of the propensity score into the model did not change this finding. The initial use of an echinocandin-based regimen does not seem to negatively influence outcome in C. parapsilosis BSI.

Sustainability of the integrated chronic disease management model at primary care clinics in South Africa.

PubMed

Mahomed, Ozayr H; Asmall, Shaidah; Voce, Anna

2016-11-17

An integrated chronic disease management (ICDM) model consisting of four components (facility reorganisation, clinical supportive management, assisted self-supportive management and strengthening of support systems and structures outside the facility) has been implemented across 42 primary health care clinics in South Africa with a view to improve the operational efficiency and patient clinical outcomes. The aim of this study was to assess the sustainability of the facility reorganisation and clinical support components 18 months after the initiation. The study was conducted at 37 of the initiating clinics across three districts in three provinces of South Africa. The National Health Service (NHS) Institute for Innovation and Improvement Sustainability Model (SM) self-assessment tool was used to assess sustainability. Bushbuckridge had the highest mean sustainability score of 71.79 (95% CI: 63.70-79.89) followed by West Rand Health District (70.25 (95% CI: 63.96-76.53)) and Dr Kenneth Kaunda District (66.50 (95% CI: 55.17-77.83)). Four facilities (11%) had an overall sustainability score of less than 55. The less than optimal involvement of clinical leadership (doctors), negative staff behaviour towards the ICDM, adaptability or flexibility of the model to adapt to external factors and infrastructure limitation have the potential to negatively affect the sustainability and scale-up of the model.

Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

PubMed

Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

2017-04-01

Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.

Do Orthopaedic Oncologists Agree on the Diagnosis and Treatment of Cartilage Tumors of the Appendicular Skeleton?

PubMed

Zamora, Tomas; Urrutia, Julio; Schweitzer, Daniel; Amenabar, Pedro Pablo; Botello, Eduardo

2017-09-01

Distinguishing a benign enchondroma from a low-grade chondrosarcoma is a common diagnostic challenge for orthopaedic oncologists. Low interrater agreement has been observed for the diagnosis of cartilaginous neoplasms among radiologists and pathologists, but, to our knowledge, no study has evaluated inter- and intraobserver agreement among orthopaedic oncologists grading these lesions using initial clinical and imaging information. Determining such agreement is important since it reflects the certainty in the diagnosis by orthopaedic oncologists. Agreement also is important as it will guide future treatment and prognosis, considering that there is no gold standard for diagnosis of these lesions. (1) to determine inter- and intraobserver agreement among a multinational panel of expert orthopaedic oncologists in diagnosing cartilaginous neoplasms based on their assessment of clinical symptoms and imaging at diagnosis. (2) To describe the most important clinical and imaging features that experts use during the initial diagnostic process. (3) To determine interobserver agreement for proposed initial treatment strategies for cartilaginous neoplasms by this panel of evaluators. Thirty-nine patients with intramedullary cartilaginous neoplasms of the appendicular skeleton of various histopathologic grades were selected and classified as having benign, low-grade malignant, or intermediate- or high-grade malignant neoplasms by 10 experienced orthopaedic oncologists based on clinical and imaging information. Additionally, they chose the three most important clinical or imaging features for the diagnosis of these neoplasms, and they proposed a treatment strategy for each patient. The Kappa coefficient (κ) was used to determine inter- and intraobserver agreement. Inter- and intraobserver agreements were only fair to good, κ = 0.44(95% CI, 0.41-0.48) and κ = 0.62 (95% CI, 0.52-0.72), respectively. The three factors most frequently identified as helpful in making the diagnosis by our panel were cortical involvement in 65% of evaluations (253/390), neoplasm size in 51% (198/390), and pain in 50% (194/390). The interobserver agreement for the proposed initial treatment strategy after diagnosis was poor (κ = 0.21; 95% CI, 0.18-0.24). This study showed barely fair interobserver and fair to good intraobserver agreement for grading of intramedullary cartilaginous neoplasms by orthopaedic oncologists using initial clinical and imaging findings. These results reflect the insufficient guidance interpreting clinical and imaging features, and the limitations of the systems we use today when making these diagnoses. In the same way, they generate concern for the implications that this may have on different treatment strategies and the future prognosis of our patients. Future studies should build on these observations and focus on clarifying our criteria of diagnosis so that treatment recommendations are standardized regardless of the treating institution or oncologist. Level III, diagnostic study.

[Secondary Splenic Rupture after Initially Inconspicuous CAT Scan].

PubMed

Prokop, A; Koll, S; Chmielnicki, M

2016-04-01

Splenic injuries occur in 1-5 % of blunt abdominal trauma cases. After initial haemorrhagic compression, secondary delayed spleen rupture can occur with a latency of one day to a month or longer. Mortality is then up to 15 %. The spleen injury is almost always recognisable on CT or ultrasound. In one case from our clinic, secondary splenic rupture occurred in a patient after discharge from hospitalisation, even though the initial CT and ultrasound were unremarkable. The patient survived, and underwent emergent splenectomy 8 days after the trauma. An expert review of the case identified no errors in treatment. No case of secondary splenic rupture after initially unremarkable diagnostic studies and clinical course has previously been published. Secondary splenic rupture has a high mortality rate. Patients should be advised of potential complications after hospital discharge, and should return to the hospital immediately in case of symptoms. Georg Thieme Verlag KG Stuttgart · New York.

Learning neuroendoscopy with an exoscope system (video telescopic operating monitor): Early clinical results.

PubMed

Parihar, Vijay; Yadav, Y R; Kher, Yatin; Ratre, Shailendra; Sethi, Ashish; Sharma, Dhananjaya

2016-01-01

Steep learning curve is found initially in pure endoscopic procedures. Video telescopic operating monitor (VITOM) is an advance in rigid-lens telescope systems provides an alternative method for learning basics of neuroendoscopy with the help of the familiar principle of microneurosurgery. The aim was to evaluate the clinical utility of VITOM as a learning tool for neuroendoscopy. Video telescopic operating monitor was used 39 cranial and spinal procedures and its utility as a tool for minimally invasive neurosurgery and neuroendoscopy for initial learning curve was studied. Video telescopic operating monitor was used in 25 cranial and 14 spinal procedures. Image quality is comparable to endoscope and microscope. Surgeons comfort improved with VITOM. Frequent repositioning of scope holder and lack of stereopsis is initial limiting factor was compensated for with repeated procedures. Video telescopic operating monitor is found useful to reduce initial learning curve of neuroendoscopy.

Preclinical to Clinical Translation of Studies of Transcranial Direct-Current Stimulation in the Treatment of Epilepsy: A Systematic Review

PubMed Central

Regner, Gabriela G.; Pereira, Patrícia; Leffa, Douglas T.; de Oliveira, Carla; Vercelino, Rafael; Fregni, Felipe; Torres, Iraci L. S.

2018-01-01

Epilepsy is a chronic brain syndrome characterized by recurrent seizures resulting from excessive neuronal discharges. Despite the development of various new antiepileptic drugs, many patients are refractory to treatment and report side effects. Non-invasive methods of brain stimulation, such as transcranial direct current stimulation (tDCS), have been tested as alternative approaches to directly modulate the excitability of epileptogenic neural circuits. Although some pilot and initial clinical studies have shown positive results, there is still uncertainty regarding the next steps of investigation in this field. Therefore, we reviewed preclinical and clinical studies using the following framework: (1) preclinical studies that have been successfully translated to clinical studies, (2) preclinical studies that have failed to be translated to clinical studies, and (3) clinical findings that were not previously tested in preclinical studies. We searched PubMed, Web of Science, Embase, and SciELO (2002–2017) using the keywords “tDCS,” “epilepsy,” “clinical trials,” and “animal models.” Our initial search resulted in 64 articles. After applying inclusion and exclusion criteria, we screened 17 full-text articles to extract findings about the efficacy of tDCS, with respect to the therapeutic framework used and the resulting reduction in seizures and epileptiform patterns. We found that few preclinical findings have been translated into clinical research (number of sessions and effects on seizure frequency) and that most findings have not been tested clinically (effects of tDCS on status epilepticus and absence epilepsy, neuroprotective effects in the hippocampus, and combined use with specific medications). Finally, considering that clinical studies on tDCS have been conducted for several epileptic syndromes, most were not previously tested in preclinical studies (Rasmussen's encephalitis, drug resistant epilepsy, and hippocampal sclerosis-induced epilepsy). Overall, most studies report positive findings. However, it is important to underscore that a successful preclinical study may not indicate success in a clinical study, considering the differences highlighted herein. Although most studies report significant findings, there are still important insights from preclinical work that must be tested clinically. Understanding these factors may improve the evidence for the potential use of this technique as a clinical tool in the treatment of epilepsy. PMID:29623027

Conversational assessment in memory clinic encounters: interactional profiling for differentiating dementia from functional memory disorders.

PubMed

Jones, Danielle; Drew, Paul; Elsey, Christopher; Blackburn, Daniel; Wakefield, Sarah; Harkness, Kirsty; Reuber, Markus

2016-01-01

In the UK dementia is under-diagnosed, there is limited access to specialist memory clinics, and many of the patients referred to such clinics are ultimately found to have functional (non-progressive) memory disorders (FMD), rather than a neurodegenerative disorder. Government initiatives on 'timely diagnosis' aim to improve the rate and quality of diagnosis for those with dementia. This study seeks to improve the screening and diagnostic process by analysing communication between clinicians and patients during initial specialist clinic visits. Establishing differential conversational profiles could help the timely differential diagnosis of memory complaints. This study is based on video- and audio recordings of 25 initial consultations between neurologists and patients referred to a UK memory clinic. Conversation analysis was used to explore recurrent communicative practices associated with each diagnostic group. Two discrete conversational profiles began to emerge, to help differentiate between patients with dementia and functional memory complaints, based on (1) whether the patient is able to answer questions about personal information; (2) whether they can display working memory in interaction; (3) whether they are able to respond to compound questions; (4) the time taken to respond to questions; and (5) the level of detail they offer when providing an account of their memory failure experiences. The distinctive conversational profiles observed in patients with functional memory complaints on the one hand and neurodegenerative memory conditions on the other suggest that conversational profiling can support the differential diagnosis of functional and neurodegenerative memory disorders.

Ghost Authorship in Industry-Initiated Randomised Trials

PubMed Central

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2007-01-01

Background Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known. Methods and Findings We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994–1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%–87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%–98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors. Conclusions Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available. PMID:17227134

Ghost authorship in industry-initiated randomised trials.

PubMed

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2007-01-01

Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known. We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994-1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%-87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%-98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors. Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available.

Impact of nurse-targeted care on HIV outcomes among immunocompromised persons: a before-after study in Uganda

PubMed Central

Kiragga, Agnes N.; Nalintya, Elizabeth; Morawski, Bozena M.; Kigozi, Joanita; Park, Benjamin J.; Kaplan, Jonathan E.; Boulware, David R.; Meya, David B.; Manabe, Yukari C.

2016-01-01

Introduction Improving HIV outcomes among severely immunocompromised HIV-infected persons who have increased morbidity and mortality remains an important issue in sub-Saharan Africa. We sought to evaluate the impact of targeted clinic- based nurse care on ART initiation and retention among severely immunocompromised HIV-infected persons. Methods The study included ART-naïve patients with CD4<100 cells/μL registered in seven urban clinics in Kampala, Uganda. Data were retrospectively collected on patients enrolled from July to December 2011 (routine care cohort). Between July 2012 and September 2013, one additional nurse per clinic was hired (nurse counselor cohort) to identify new patients, expedite ART initiation and trace those loss-to-follow-up. We compared time to ART initiation and 6-month retention in care between cohorts and used a generalized linear model to estimate the relative risk of retention. Results The study included 258 patients in the routine care cohort and 593 in the nurse counselor cohort. The proportion of patients who initiated ART increased from 190 (73.6%) in the routine care cohort to 506 (85.3%) in the nurse counselor cohort (p<0.001). At 6 months, 62% of the routine care cohort were retained in care versus 76% in the nurse counselor cohort (p=0.001). A 21% increase in likelihood of retention in the nurse counselor cohort (relative risk 1.21, 95% CI, 1.09–1.34) compared with the routine care cohort was observed. Conclusion Implementation of targeted nurse–led care of severely immunocompromised HIV-infected patients in public outpatient health care facilities resulted in decreased time to ART initiation and increased retention. PMID:27003494

Follow-Up Study of Reading Achievement in Learning Disabled Children.

ERIC Educational Resources Information Center

Gottesman, Ruth L.

Forty-three learning disabled children referred initially between ages 7 and 14 years to a medical outpatient clinic for developmentally disabled children were evaluated and followed for a period of 5 to 7 years after which their level of academic achievement was reassessed. Initial evaluation included pediatric, neurological and developmental…

The Telemetric and Holter ECG Warehouse Initiative (THEW): a Data Repository for the Design, Implementation and Validation of ECG-related Technologies

PubMed Central

Couderc, Jean-Philippe

2011-01-01

We present an initiative supported by the National Heart Lung, and Blood Institute and the Food and Drug Administration for the development of a repository containing continuous electrocardiographic information to be shared with the worldwide scientific community. We believe that sharing data reinforces open scientific inquiry. It encourages diversity of analysis and opinion while promoting new research and facilitating the education of new researchers. In this paper, we present the resources available in this initiative for the scientific community. We describe the set of ECG signals currently hosted and we briefly discuss the associated clinical information (medical history. Disease and study-specific endpoints) and software tools we propose. Currently, the repository contains more than 250GB of data from eight clinical studies including healthy individuals and cardiac patients. This data is available for the development, implementation and validation of technologies related to body-surface ECGs. To conclude, the Telemetric and Holter ECG Warehouse (THEW) is an initiative developed to benefit the scientific community and to advance the field of quantitative electrocardiography and cardiac safety. PMID:21097349

School-Based Health Clinics: An Analysis of the Johns Hopkins Study. Research Developments.

ERIC Educational Resources Information Center

Demsko, Tobin W.

School-based health clinics, adolescent pregnancy prevention programs offering comprehensive health services, represent the latest initiative to reduce the incidence of teenage pregnancy. Researchers at Johns Hopkins University designed and administered a pregnancy prevention program which offered sexuality education and family planning services…

Undergraduate student nurses' lived experiences of anxiety during their first clinical practicum: A phenomenological study.

PubMed

Sun, Fan-Ko; Long, Ann; Tseng, Yun Shan; Huang, Hui-Man; You, Jia-Hui; Chiang, Chun-Ying

2016-02-01

The Fundamental Nursing clinical practicum is an essential module for nursing students. Some feel stress or anxiety about attending this first placement; however, evidence demonstrates that it is rare to explore the feelings of anxiety felt by the nursing students concerning their first clinical practicum. This study was designed to explore student nurses' experiences of anxiety felt regarding their initial clinical practicum while studying for their University degree. A phenomenological approach was used. A university in Southern Taiwan. A purposive sampling of fifteen student nurses with anxiety reactions who had completed their first clinical practicum. Data were collected using a semi-structured guide and deep interview. Data were analyzed using Colaizzi's seven-step phenomenological method. Three themes surfaced in the findings. The first theme was anxiety around their first clinical practicum, which stirred up anxiety about: self-doubt, worry and fear; difficulty coping with the learning process; worry hampered establishing therapeutic relationships with patients; the progress of the patients' illness could not be predicted; and anxiety felt about lecturer-student interactions. The second theme was three phases of anxiety reactions, which included increasing anxiety before clinical practicum; exacerbated anxiety during clinical practicum, and relief of anxiety after clinical practicum. The third theme was coping behaviors. This comprised: self-reflection in preparation for clinical practicum; finding ways to release emotions; distractions from the anxiety; and, also facing their difficulties head-on. The findings could help raise the awareness of lecturers and students by understanding student nurses' anxiety experiences and facilitating a healthy preparation for their initial clinical practicum, consequently proactively helping reduce potential anxiety experiences. Copyright © 2015 Elsevier Ltd. All rights reserved.

Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Freitas, C S; Marcon, R; Schwanke, R C; Siqueira, J M; Calixto, J B

2016-10-24

This review presents a historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies. Collectively, improving these aspects will certainly contribute to the robustness of both scientific publications and the translation of new substances to clinical development.

Implementation of a clinical pharmacy specialist-managed telephonic hospital discharge follow-up program in a patient-centered medical home.

PubMed

Anderson, Sarah L; Marrs, Joel C; Vande Griend, Joseph P; Hanratty, Rebecca

2013-08-01

The objectives of this retrospective study were to examine the feasibility and characteristics that define successful implementation of a Clinical Pharmacy Specialist (CPS) telephonic hospital discharge follow-up quality improvement initiative, as well as the impact of this initiative. Adult patients who were discharged from a safety-net hospital between July 1, 2010 and June 30, 2011 and who were part of a patient-centered medical home were included in this quality improvement initiative. CPSs attempted to contact 470 patients; of those, 207 received the intervention and 263 did not. Patients in the contacted group were more likely to attend a hospital discharge follow-up appointment (66.2% vs. 44.5%, P<0.01) and had lower rates of 30-day readmission (22 vs. 52, P<0.01) compared to those who were not contacted. Institutions should consider allocating resources for pharmacist-managed posthospital discharge follow-up services because of the potential for positive clinical and financial impact.

Effect of clinical decision rules, patient cost and malpractice information on clinician brain CT image ordering: a randomized controlled trial.

PubMed

Gimbel, Ronald W; Pirrallo, Ronald G; Lowe, Steven C; Wright, David W; Zhang, Lu; Woo, Min-Jae; Fontelo, Paul; Liu, Fang; Connor, Zachary

2018-03-12

The frequency of head computed tomography (CT) imaging for mild head trauma patients has raised safety and cost concerns. Validated clinical decision rules exist in the published literature and on-line sources to guide medical image ordering but are often not used by emergency department (ED) clinicians. Using simulation, we explored whether the presentation of a clinical decision rule (i.e. Canadian CT Head Rule - CCHR), findings from malpractice cases related to clinicians not ordering CT imaging in mild head trauma cases, and estimated patient out-of-pocket cost might influence clinician brain CT ordering. Understanding what type and how information may influence clinical decision making in the ordering advanced medical imaging is important in shaping the optimal design and implementation of related clinical decision support systems. Multi-center, double-blinded simulation-based randomized controlled trial. Following standardized clinical vignette presentation, clinicians made an initial imaging decision for the patient. This was followed by additional information on decision support rules, malpractice outcome review, and patient cost; each with opportunity to modify their initial order. The malpractice and cost information differed by assigned group to test the any temporal relationship. The simulation closed with a second vignette and an imaging decision. One hundred sixteen of the 167 participants (66.9%) initially ordered a brain CT scan. After CCHR presentation, the number of clinicians ordering a CT dropped to 76 (45.8%), representing a 21.1% reduction in CT ordering (P = 0.002). This reduction in CT ordering was maintained, in comparison to initial imaging orders, when presented with malpractice review information (p = 0.002) and patient cost information (p = 0.002). About 57% of clinicians changed their order during study, while 43% never modified their imaging order. This study suggests that ED clinician brain CT imaging decisions may be influenced by clinical decision support rules, patient out-of-pocket cost information and findings from malpractice case review. NCT03449862 , February 27, 2018, Retrospectively registered.

Crossing the gender boundaries: The gender experiences of male nursing students in initial nursing clinical practice in Taiwan.

PubMed

Liu, Hsing-Yuan; Li, Yun Ling

2017-11-01

The initial nursing clinical practice is the necessary practicum required for nursing students. Because of the changing learning style, many of them are under great pressure for environmental change and therefore their daily routine is severe affected. Interacting directly with patients in a female-dominated occupation, along with the general gender stereotypes, the impact is especially significant to male nursing students than to female nursing students. The purpose of this preliminary qualitative study is to explore the gendered experiences of male nursing students during their first initial nursing clinical practice. Both focus group interviews and individual interviews are conducted with twenty-two sophomore nursing students from a university of technology in northern Taiwan, with ten male students and twelve female students. Two main themes emerge from the gendered experiences shared by the nursing students: Gender consciousness awakening and thus maintaining masculinity, and male advantage in the learning environments. The results identify the specific gendered experiences of nursing students, providing implications for future nursing education and counseling service. Further, this study may serve to promote an active yet gender-sensitive nursing education for training nursing professionals. Published by Elsevier Ltd.

Physical examination prior to initiating hormonal contraception: a systematic review.

PubMed

Tepper, Naomi K; Curtis, Kathryn M; Steenland, Maria W; Marchbanks, Polly A

2013-05-01

Provision of contraception is often linked with physical examination, including clinical breast examination (CBE) and pelvic examination. This review was conducted to evaluate the evidence regarding outcomes among women with and without physical examination prior to initiating hormonal contraceptives. The PubMed database was searched from database inception through March 2012 for all peer-reviewed articles in any language concerning CBE and pelvic examination prior to initiating hormonal contraceptives. The quality of each study was assessed using the United States Preventive Services Task Force grading system. The search did not identify any evidence regarding outcomes among women screened versus not screened with CBE prior to initiation of hormonal contraceptives. The search identified two case-control studies of fair quality which compared women who did or did not undergo pelvic examination prior to initiating oral contraceptives (OCs) or depot medroxyprogesterone acetate (DMPA). No differences in risk factors for cervical neoplasia, incidence of sexually transmitted infections, incidence of abnormal Pap smears or incidence of abnormal wet mount findings were observed. Although women with breast cancer should not use hormonal contraceptives, there is little utility in screening prior to initiation, due to the low incidence of breast cancer and uncertain value of CBE among women of reproductive age. Two fair quality studies demonstrated no differences between women who did or did not undergo pelvic examination prior to initiating OCs or DMPA with respect to risk factors or clinical outcomes. In addition, pelvic examination is not likely to detect any conditions for which hormonal contraceptives would be unsafe. Published by Elsevier Inc.

Cardiovascular tissue engineering: where we come from and where are we now?

PubMed

Smit, Francis E; Dohmen, Pascal M

2015-01-27

Abstract Tissue engineering was introduced by Vacanti and Langer in the 80's, exploring the potential of this new technology starting with the well-known "human ear on the mouse back". The goal is to create a substitute which supplies an individual therapy for patients with regeneration, remodeling and growth potential. The growth potential of these subjects is of special interest in congenital cardiac surgery, avoiding repeated interventions and surgery. Initial applications of tissue engineered created substitutes were relatively simple cardiovascular grafts seeded initially by end-differentiated autologous endothelial cells. Important data were collected from these initial clinical autologous endothelial cell seeded grafts in peripheral and coronary vessel disease. After these initial successfully implantation bone marrow cell were used to seed patches and pulmonary conduits were implanted in patients. Driven by the positive results of tissue engineered material implanted under low pressure circumstances, first tissue engineered patches were implanted in the systemic circulation followed by the implantation of tissue engineered aortic heart valves. Tissue engineering is an extreme dynamic technology with continuously modifications and improvements to optimize clinical products. New technologies are unified and so this has also be done with tissue engineering and new application features, so called transcatheter valve intervention. First studies are initiated to apply tissue engineered heart valves with this new transcatheter delivery system less invasive. Simultaneously studies have been started on tissue engineering of so-called whole organs since organ transplantation is restricted due to donor shortage and tissue engineering could overcome this problem. Initial studies of whole heart engineering in the rat model are promising and larger size models are initiated.

The fate of prospective spine studies registered on www.ClinicalTrials.gov.

PubMed

Ohnmeiss, Donna D

2015-03-01

There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by invitation, 13 not yet recruiting, 18 terminated, 4 withdrawn, and 1 suspended. Among the 72 studies indicated to be completed, 28 (38.9%) have been published. The mean time to publish was 27.9 months from the date of completion. Among unpublished studies, the mean length of time from study completion to the preparation of this article was 62.0 months. There was no difference in the likelihood of publication based on the geographic region of study origin or whether the study was registered before or after initiation. There were statistically significant relationships between the publication rate and the funding type as well as the research type (p<.05) with industrial-funded studies and those evaluating devices having a lower publication rate and those that were funded by a federal agency and comparing surgery to nonoperative care had the highest publication rates. Although the 38.9% publication rate for spine-related studies found in this study appears low, it is in line with other studies reporting a 22.8% publication rate for arthroplasty trials and 43.2% for orthopedic trauma trials. In addition to ClinicalTrials.gov Web site fulfilling its original goal of providing patients information about clinical studies, it can also provide a means of tracking publication of prospective studies, changes to protocols, matching publication content to posted study design, and others and raise queries concerning the reasons for not publishing what appear to be well-designed studies. The posting of spine studies before initiation can increase transparency and ability to evaluate clinical trials in spine. Copyright © 2015 Elsevier Inc. All rights reserved.

HPV vaccination: Population approaches for improving rates.

PubMed

Oliver, Kristin; Frawley, Alean; Garland, Elizabeth

2016-06-02

To review the literature on interventions to increase HPV vaccinations and assess whether The Community Preventive Services Task Force recommendations are supported by current evidence. We used a PubMed search to identify studies that assessed interventions that looked at provider assessment and feedback, provider reminders, client reminder and recall, and clinic based education programs. Of the 13 studies identified, 8 included client reminder and recall interventions, 4 included provider assessment and feedback and/or provider reminders and 2 included clinic based education. 11 of the 13 studies demonstrated a positive effect on HPV vaccine initiation or completion. Provider assessment and feedback studies were more likely to report a positive effect on HPV vaccine initiation than on series completion, while client reminder recall interventions more frequently produced an effect on series completion than on initiation. There is evidence to support the application of the Community Preventive Services Task Force recommendations specifically to HPV vaccination both for client reminder and recall programs and for provider assessment and feedback interventions. Multiple targeted approaches will be needed to substantially impact HPV vaccine rates.

Perceptions of Supervision Processes and Practices in Initial Contract, Tenured, and Distinguished-Rated Teachers as They Relate to Self-Learning and Growth in One Large Suburban School District

ERIC Educational Resources Information Center

Watters, Chad M.

2017-01-01

The purpose of this mixed methods study is to examine the perceptions of supervision practices in initial contract, tenured, and distinguished-rated teachers at the elementary level in one large, suburban school district. This study described teacher perceptions of clinical and alternative supervision practices. Six research questions guided this…

Pigmented extramammary Paget’s disease of the axilla mimicking melanoma: case report and review of the literature

PubMed Central

Hilliard, Nicholaus J; Huang, Conway; Andea, Aleodor

2010-01-01

Pigmented Paget’s disease is a rare variant which is often confused clinically and histologically with melanoma in situ. Herein, we describe a case of pigmented extramammary Paget’s disease involving the axilla of a 79 year old white male thought initially to represent malignant melanoma clinically and histologically. Review of the literature reveals that pigmented variant of Paget’s disease, either mammary or extramammary, could be initially misdiagnosed as melanoma unless this entity is considered in the differential diagnosis and additional confirmatory studies are performed. PMID:19674203

Clinical cure and survival in Gram-positive ventilator-associated pneumonia: retrospective analysis of two double-blind studies comparing linezolid with vancomycin.

PubMed

Kollef, Marin H; Rello, Jordi; Cammarata, Sue K; Croos-Dabrera, Rodney V; Wunderink, Richard G

2004-03-01

To assess the effect of baseline variables, including treatment, on clinical cure and survival rates in patients with Gram-positive, ventilator-associated pneumonia (VAP). Retrospective analysis of two randomized, double-blind studies. Multinational study with 134 sites. 544 patients with suspected Gram-positive VAP, including 264 with documented Gram-positive VAP and 91 with methicillin-resistant S. aureus (MRSA) VAP. Linezolid 600 mg or vancomycin 1 g every 12 h for 7-21 days, each with aztreonam. Clinical cure rates assessed 12-28 days after the end of therapy and excluding indeterminate or missing outcomes significantly favored linezolid in the Gram-positive and MRSA subsets. Logistic regression showed that linezolid was an independent predictor of clinical cure with odds ratios of 1.8 for all patients, 2.4 for Gram-positive VAP, and 20.0 for MRSA VAP. Kaplan-Meier survival rates favored linezolid in the MRSA subset. Logistic regression showed that linezolid was an independent predictor of survival with odds ratios of 1.6 for all patients, 2.6 for Gram-positive VAP, and 4.6 for MRSA VAP. Initial linezolid therapy was associated with significantly better clinical cure and survival rates than was initial vancomycin therapy in patients with MRSA VAP.

Early initiation of beta blockade in heart failure: issues and evidence.

PubMed

Williams, Randall E

2005-09-01

Despite clinical trials demonstrating that inhibitors of the renin-angiotensin and sympathetic nervous systems can reduce the mortality and morbidity risk associated with heart failure, these drugs have remained underutilized in general clinical practice. In particular, many patients with heart failure due to left ventricular systolic dysfunction fail to receive beta blockers, although this class of drugs, as well as other antihypertensive agents such as angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, are recommended as part of routine heart failure therapy by national expert consensus guidelines. In-hospital initiation of beta-blocker therapy may improve long-term utilization by physicians and compliance by patients through obviating many of the misperceived dangers associated with beta blockade. The following review of the clinical trial data from the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) trial, the Metoprolol Controlled-Release Randomized Intervention Trial in Heart Failure (MERIT-HF), the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial, and the Initiation Management Predischarge Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) trial on the efficacy, safety, and tolerability of beta blockers indicates that early initiation can be safely achieved and can improve patient outcomes.

Clinical significance of quantitative analysis of facial nerve enhancement on MRI in Bell's palsy.

PubMed

Song, Mee Hyun; Kim, Jinna; Jeon, Ju Hyun; Cho, Chang Il; Yoo, Eun Hye; Lee, Won-Sang; Lee, Ho-Ki

2008-11-01

Quantitative analysis of the facial nerve on the lesion side as well as the normal side, which allowed for more accurate measurement of facial nerve enhancement in patients with facial palsy, showed statistically significant correlation with the initial severity of facial nerve inflammation, although little prognostic significance was shown. This study investigated the clinical significance of quantitative measurement of facial nerve enhancement in patients with Bell's palsy by analyzing the enhancement pattern and correlating MRI findings with initial severity of facial palsy and clinical outcome. Facial nerve enhancement was measured quantitatively by using the region of interest on pre- and postcontrast T1-weighted images in 44 patients diagnosed with Bell's palsy. The signal intensity increase on the lesion side was first compared with that of the contralateral side and then correlated with the initial degree of facial palsy and prognosis. The lesion side showed significantly higher signal intensity increase compared with the normal side in all of the segments except for the mastoid segment. Signal intensity increase at the internal auditory canal and labyrinthine segments showed correlation with the initial degree of facial palsy but no significant difference was found between different prognostic groups.

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

PubMed

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

Partners | Office of Cancer Clinical Proteomics Research

Cancer.gov

Developmental Studies Hybridoma Bank at the University of Iowa NCI’s OCCPR works closely with The University of Iowa's Developmental Studies Hybridoma Bank (DSHB) that distributes all hybridomas and monoclonal antibodies from NCI's Clinical Proteomic Technologies for Cancer initiative (CPTC). DSHB supplies researchers with monoclonal antibodies, which may be ordered as tissue culture supernatants, ascites, or concentrate; selected hybridomas are also available as frozen or growing cells.

Does participation in a weight control program also improve clinical and functional outcomes for Chinese patients with schizophrenia treated with olanzapine?

PubMed Central

Montgomery, William; Treuer, Tamas; Ye, Wenyu; Xue, Hai Bo; Wu, Sheng Hu; Liu, Li; Kadziola, Zbigniew; Stensland, Michael D; Ascher-Svanum, Haya

2014-01-01

Objectives This study examined whether participation in a weight control program (WCP) by patients with schizophrenia treated with olanzapine was also associated with improvements in clinical and functional outcomes. Methods A post-hoc analysis was conducted using data from the Chinese subgroup (n=330) of a multi-country, 6-month, prospective, observational study of outpatients with schizophrenia who initiated or switched to oral olanzapine. At study entry and monthly visits, participants were assessed with the Clinical Global Impression of Severity, and measures of patient insight, social activities, and work impairment. The primary comparison was between the 153 patients who participated in a WCP at study entry (n=93) or during the study (n=60) and the 177 patients who did not participate in a weight control program (non-WCP). Mixed Models for Repeated Measures with baseline covariates were used to compare outcomes over time. Kaplan–Meier survival analysis was used to assess time to response. Results Participants had a mean age of 29.0 years and 29.3 years, and 51.0% and 57.6% were female for WCP and non-WCP groups, respectively. Average initiated daily dose for olanzapine was 9.5±5.4 mg. WCP participants gained less weight than non-participants (3.9 kg vs 4.9 kg, P=0.03) and showed statistically significant better clinical and functional outcomes: greater improvement in illness severity (−2.8 vs −2.1, P<0.001), higher treatment response rates (94.1% vs 80.9%, P<0.001), shorter time to response (P<0.001), and greater improvement in patients’ insight (P<0.001). Patients who enrolled in a WCP during the study had greater initial weight gain than those who enrolled at baseline (P<0.05), but similar total weight gain. Conclusion Participation in a WCP may not only lower the risk of clinically significant weight gain in olanzapine-treated patients, but may also be associated with additional clinical and functional benefits. PMID:25031537

Timing of the initiation of parenteral nutrition in critically ill children.

PubMed

Jimenez, Lissette; Mehta, Nilesh M; Duggan, Christopher P

2017-05-01

To review the current literature evaluating clinical outcomes of early and delayed parenteral nutrition initiation among critically ill children. Nutritional management remains an important aspect of care among the critically ill, with enteral nutrition generally preferred. However, inability to advance enteral feeds to caloric goals and contraindications to enteral nutrition often leads to reliance on parenteral nutrition. The timing of parenteral nutrition initiation is varied among critically ill children, and derives from an assessment of nutritional status, energy requirements, and physiologic differences between adults and children, including higher nutrient needs and lower body reserves. A recent randomized control study among critically ill children suggests improved clinical outcomes with avoiding initiation of parenteral nutrition on day 1 of admission to the pediatric ICU. Although there is no consensus on the optimal timing of parenteral nutrition initiation among critically ill children, recent literature does not support the immediate initiation of parenteral nutrition on pediatric ICU admission. A common theme in the reviewed literature highlights the importance of accurate assessment of nutritional status and energy expenditure in deciding when to initiate parenteral nutrition. As with all medical interventions, the initiation of parenteral nutrition should be considered in light of the known benefits of judiciously provided nutritional support with the known risks of artificial, parenteral feeding.

Timing of the initiation of parenteral nutrition in critically ill children

PubMed Central

Jimenez, Lissette; Mehta, Nilesh M.; Duggan, Christopher

2018-01-01

Purpose of Review To review the current literature evaluating clinical outcomes of early and delayed parenteral nutrition initiation among critically ill children. Recent Findings Nutritional management remains an important aspect of care among the critically ill, with enteral nutrition (EN) generally preferred. However, inability to advance enteral feeds to caloric goals and contraindications to EN often leads to reliance on parenteral nutrition (PN). The timing of PN initiation is varied among critically ill children, and derives from an assessment of nutritional status, energy requirements, and physiologic differences between adults and children, including higher nutrient needs and lower body reserves. A recent randomized control study among critically ill children suggests improved clinical outcomes with postponing initiation of PN to 1 week after admission to the pediatric intensive care unit (PICU). Summary Although there is no consensus on the optimal timing of PN initiation among critically ill children, recent literature does not support the immediate initiation of PN on PICU admission. A common theme in the reviewed literature highlights the importance of accurate assessment of nutritional status and energy expenditure in deciding when to initiate PN. As with all medical interventions, the initiation of PN should be considered in light of the known benefits of judiciously provided nutritional support with the known risks of artificial, parenteral feeding. PMID:28376054

Distinct dynamic profiles of microglial activation are associated with progression of Alzheimer's disease.

PubMed

Hamelin, Lorraine; Lagarde, Julien; Dorothée, Guillaume; Potier, Marie Claude; Corlier, Fabian; Kuhnast, Bertrand; Caillé, Fabien; Dubois, Bruno; Fillon, Ludovic; Chupin, Marie; Bottlaender, Michel; Sarazin, Marie

2018-06-01

Although brain neuroinflammation may play an instrumental role in the pathophysiology of Alzheimer's disease, its actual impact on disease progression remains controversial, being reported as either detrimental or protective. This work aimed at investigating the temporal relationship between microglial activation and clinical progression of Alzheimer's disease. First, in a large cohort of patients with Alzheimer's disease we analysed the predictive value of microglial activation assessed by 18F-DPA-714 PET imaging on functional, cognitive and MRI biomarkers outcomes after a 2-year follow-up. Second, we analysed the longitudinal progression of 18F-DPA-714 binding in patients with Alzheimer's disease by comparison with controls, and assessed its influence on clinical progression. At baseline, all participants underwent a clinical assessment, brain MRI, 11C-PiB, 18F-DPA-714 PET imaging and TSPO genotyping. Participants were followed-up annually for 2 years. At the end of the study, subjects were asked to repeat a second 18F-DPA-714-PET imaging. Initial 18F-DPA-714 binding was higher in prodromal (n = 33) and in demented patients with Alzheimer's disease (n = 19) compared to controls (n = 17). After classifying patients into slow and fast decliners according to functional (Clinical Dementia Rating change) or cognitive (Mini-Mental State Examination score decline) outcomes, we found a higher initial 18F-DPA-714 binding in slow than fast decliners. Negative correlations were observed between initial 18F-DPA-714 binding and the Clinical Dementia Rating Sum of Boxes score increase, the MMSE score loss and the progression of hippocampal atrophy. This suggests that higher initial 18F-DPA-714 binding is associated with better clinical prognosis. Twenty-four patients with Alzheimer's disease and 15 control subjects performed a second DPA-PET. We observed an increase of 18F-DPA-714 in patients with Alzheimer's disease as compared with controls (mean 13.2% per year versus 4.2%) both at the prodromal (15.8%) and at the demented stages (8.3%). The positive correlations between change in 18F-DPA-714 binding over time and the three clinical outcome measures (Clinical Dementia Rating, Mini-Mental State Examination, hippocampal atrophy) suggested a detrimental effect on clinical Alzheimer's disease progression of increased neuroinflammation after the initial PET examination, without correlation with PiB-PET uptake at baseline. High initial 18F-DPA-714 binding was correlated with a low subsequent increase of microglial activation and favourable clinical evolution, whereas the opposite profile was observed when initial 18F-DPA-714 binding was low, independently of disease severity at baseline. Taken together, our results support a pathophysiological model involving two distinct profiles of microglial activation signatures with different dynamics, which differentially impact on disease progression and may vary depending on patients rather than disease stages.

Games in clinical genetic counseling supervision.

PubMed

McIntosh, Nathalie; Dircks, Anita; Fitzpatrick, Jennifer; Shuman, Cheryl

2006-08-01

Games are defined as ongoing series of complementary ulterior transactions that are superficially plausible but have a concealed motivation to maximize pay-offs and minimize penalties for the initiator. While some games are harmless and part of socialization, others are destructive. Destructive game-playing in clinical supervision, in which game-playing (initiated by either supervisors or students) interferes with a student's realization of internship goals, has been documented in some allied healthcare professions but has not yet been studied in genetic counseling. Genetic counselors and clinical supervisors of genetic counseling students were anonymously surveyed regarding their experiences with destructive game-playing. Results show that such games do occur in genetic counseling clinical supervision. Some games are the same or similar to ones previously described in other health-care professions; others may be unique to genetic counseling. The purpose of this paper is to document these games as a first step to facilitating dialogue, understanding and awareness of them.

Improved Clinical Performance and Teamwork of Pediatric Interprofessional Resuscitation Teams With a Simulation-Based Educational Intervention.

PubMed

Gilfoyle, Elaine; Koot, Deanna A; Annear, John C; Bhanji, Farhan; Cheng, Adam; Duff, Jonathan P; Grant, Vincent J; St George-Hyslop, Cecilia E; Delaloye, Nicole J; Kotsakis, Afrothite; McCoy, Carolyn D; Ramsay, Christa E; Weiss, Matthew J; Gottesman, Ronald D

2017-02-01

To measure the effect of a 1-day team training course for pediatric interprofessional resuscitation team members on adherence to Pediatric Advanced Life Support guidelines, team efficiency, and teamwork in a simulated clinical environment. Multicenter prospective interventional study. Four tertiary-care children's hospitals in Canada from June 2011 to January 2015. Interprofessional pediatric resuscitation teams including resident physicians, ICU nurse practitioners, registered nurses, and registered respiratory therapists (n = 300; 51 teams). A 1-day simulation-based team training course was delivered, involving an interactive lecture, group discussions, and four simulated resuscitation scenarios, each followed by a debriefing. The first scenario of the day (PRE) was conducted prior to any team training. The final scenario of the day (POST) was the same scenario, with a slightly modified patient history. All scenarios included standardized distractors designed to elicit and challenge specific teamwork behaviors. Primary outcome measure was change (before and after training) in adherence to Pediatric Advanced Life Support guidelines, as measured by the Clinical Performance Tool. Secondary outcome measures were as follows: 1) change in times to initiation of chest compressions and defibrillation and 2) teamwork performance, as measured by the Clinical Teamwork Scale. Correlation between Clinical Performance Tool and Clinical Teamwork Scale scores was also analyzed. Teams significantly improved Clinical Performance Tool scores (67.3-79.6%; p < 0.0001), time to initiation of chest compressions (60.8-27.1 s; p < 0.0001), time to defibrillation (164.8-122.0 s; p < 0.0001), and Clinical Teamwork Scale scores (56.0-71.8%; p < 0.0001). A positive correlation was found between Clinical Performance Tool and Clinical Teamwork Scale (R = 0.281; p < 0.0001). Participation in a simulation-based team training educational intervention significantly improved surrogate measures of clinical performance, time to initiation of key clinical tasks, and teamwork during simulated pediatric resuscitation. A positive correlation between clinical and teamwork performance suggests that effective teamwork improves clinical performance of resuscitation teams.

Conservatively treated massive prolapsed discs: a 7-year follow-up

PubMed Central

Benson, RT; Tavares, SP; Robertson, SC; Sharp, R; Marshall, RW

2010-01-01

INTRODUCTION The natural history of a lumbar hernia of the nucleus pulposus (HNP) is not fully known and clear indications for operative intervention cannot be established from the literature. Several studies have shown that the largest discs appear to have the greatest tendency to resolve. The aim of this study was to investigate whether massive prolapsed discs can be safely managed conservatively once clinical improvement has occurred. PATIENTS AND METHODS Thirty-seven patients were studied by clinical assessments and serial magnetic resonance imaging (MRI) over 2 years. Patients had severe sciatica at first, but began to show clinical improvement despite the large disc hernia-tions. Clinical assessment included the Lasegue test and neurological appraisal. The Oswestry Disability Index was used to measure function and changes in function. Serial MRI studies allowed measurement of volume changes of the herniated disc material over a period of time. RESULTS Initial follow-up at an average of 23.2 months revealed that 83% had a complete and sustained recovery at the initial follow-up. Only four patients required a discectomy. The average Oswestry disability index improved from 58% to 15%. Volumetric analysis of serial MRI scans found an average reduction of 64% in disc size. There was a poor correlation between clinical improvement and the extent of disc resolution. CONCLUSIONS A massive disc herniation can pursue a favourable clinical course. If early progress is shown, the long-term prognosis is very good and even massive disc herniations can be treated conservatively. PMID:19887021

Use of an Orientation Clinic to Reduce Failed New Patient Appointments in Primary Care

PubMed Central

Jain, Sharad; Chou, Calvin L

2000-01-01

Patients who fail to attend initial appointments reduce clinic efficiency. To maximize attendance by newly referred outpatients, we introduced a mandatory group orientation clinic for all new patients and determined its effects on no-show rates. Orientation clinic also provided health care screening and opportunities for patient feedback. The new patient no-show rate for initial provider visits decreased significantly from 45% before institution of orientation clinic to 18% afterwards (P < .0001). The total no-show (patients who failed to attend orientation clinic or an initial provider visit) rate of the postintervention group was 51% (P = .28, compared with before the intervention). This intervention improved the efficiency and minimized the wasted time of our clinicians. PMID:11119184

Early detection and treatment of sexually transmitted disease in pregnant adolescents of low socioeconomic status.

PubMed

Matson, S C; Pomeranz, A J; Kamps, K A

1993-10-01

This study evaluated the prevalence of sexually transmitted disease (STD) in adolescents presenting to a primary pediatric care clinic (PPCC) for the diagnosis of pregnancy and our ability to eradicate identified infections. We followed 168 pregnant adolescents of low socioeconomic status from their original pregnancy diagnosis until their first prenatal clinic visit. We collected screening cervical cultures for Neisseria gonorrhoeae and Chlamydia trachomatis by completing a pelvic examination on 91 patients at our PPCC. At the PPCC visit, 29% were positive for gonorrhea, chlamydia, or both. Screening tests for these infections were collected on all patients at the initial prenatal clinic visit. The risk for presenting to the prenatal clinic with a STD was significantly greater in patients not screened and treated for STD at the PPCC. Average delay from diagnosis to first prenatal clinic visit was 35.7 days. Thus, in this adolescent population, primary care providers are missing an important therapeutic opportunity by failing to identify and treat STD at initial diagnosis of pregnancy.

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.

PubMed

Hicks, Karen A; Mahaffey, Kenneth W; Mehran, Roxana; Nissen, Steven E; Wiviott, Stephen D; Dunn, Billy; Solomon, Scott D; Marler, John R; Teerlink, John R; Farb, Andrew; Morrow, David A; Targum, Shari L; Sila, Cathy A; Thanh Hai, Mary T; Jaff, Michael R; Joffe, Hylton V; Cutlip, Donald E; Desai, Akshay S; Lewis, Eldrin F; Gibson, C Michael; Landray, Martin J; Lincoff, A Michael; White, Christopher J; Brooks, Steven S; Rosenfield, Kenneth; Domanski, Michael J; Lansky, Alexandra J; McMurray, John J V; Tcheng, James E; Steinhubl, Steven R; Burton, Paul; Mauri, Laura; O'Connor, Christopher M; Pfeffer, Marc A; Hung, H M James; Stockbridge, Norman L; Chaitman, Bernard R; Temple, Robert J

2018-03-06

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials. Copyright © 2018 American College of Cardiology Foundation and American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.

Development and initial evaluation of an instrument to assess physiotherapists' clinical reasoning focused on clients' behavior change.

PubMed

Elvén, Maria; Hochwälder, Jacek; Dean, Elizabeth; Söderlund, Anne

2018-05-01

A systematically developed and evaluated instrument is needed to support investigations of physiotherapists' clinical reasoning integrated with the process of clients' behavior change. This study's aim was to develop an instrument to assess physiotherapy students' and physiotherapists' clinical reasoning focused on clients' activity-related behavior and behavior change, and initiate its evaluation, including feasibility and content validity. The study was conducted in three phases: 1) determination of instrument structure and item generation, based on a model, guidelines for assessing clinical reasoning, and existing measures; 2) cognitive interviews with five physiotherapy students to evaluate item understanding and feasibility; and 3) a Delphi process with 18 experts to evaluate content relevance. Phase 1 resulted in an instrument with four domains: Physiotherapist; Input from client; Functional behavioral analysis; and Strategies for behavior change. The instrument consists of case scenarios followed by items in which key features are identified, prioritized, or interpreted. Phase 2 resulted in revisions of problems and approval of feasibility. Phase 3 demonstrated high level of consensus regarding the instrument's content relevance. This feasible and content-validated instrument shows potential for use in investigations of physiotherapy students' and physiotherapists' clinical reasoning, however continued development and testing are needed.

Undergraduate nursing students' stress sources and coping behaviours during their initial period of clinical training: a Jordanian perspective.

PubMed

Shaban, Insaf A; Khater, Wejdan A; Akhu-Zaheya, Laila M

2012-07-01

Baccalaureate nursing students often experience high levels of stress during training that may result in psychological or emotional impairment during their professional life ultimately affecting the quality of patient care they provide. Clinical instructors provide the needed support and guidance for students to relieve stress and promote a positive clinical experience. The aim of this study was to identify the level and types of stress perceived by baccalaureate nursing students in Jordan in their initial period of clinical practice and to identify the coping strategies that students used to relieve their stress. This descriptive cross-sectional study was conducted with 181 nursing students' representative of second year undergraduate students from two universities in Jordan. Proportions and t-tests were used to analyze the data. The results showed that the source of stress for these students came mainly from assignment work and the clinical environment. The most common coping strategy used by students was problem-solving behaviour followed by staying optimistic and transference attention from the stressful situation to other things while avoidance was the least frequent used. Copyright © 2012 Elsevier Ltd. All rights reserved.

Reagent-free bacterial identification using multivariate analysis of transmission spectra

NASA Astrophysics Data System (ADS)

Smith, Jennifer M.; Huffman, Debra E.; Acosta, Dayanis; Serebrennikova, Yulia; García-Rubio, Luis; Leparc, German F.

2012-10-01

The identification of bacterial pathogens from culture is critical to the proper administration of antibiotics and patient treatment. Many of the tests currently used in the clinical microbiology laboratory for bacterial identification today can be highly sensitive and specific; however, they have the additional burdens of complexity, cost, and the need for specialized reagents. We present an innovative, reagent-free method for the identification of pathogens from culture. A clinical study has been initiated to evaluate the sensitivity and specificity of this approach. Multiwavelength transmission spectra were generated from a set of clinical isolates including Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus. Spectra of an initial training set of these target organisms were used to create identification models representing the spectral variability of each species using multivariate statistical techniques. Next, the spectra of the blinded isolates of targeted species were identified using the model achieving >94% sensitivity and >98% specificity, with 100% accuracy for P. aeruginosa and S. aureus. The results from this on-going clinical study indicate this approach is a powerful and exciting technique for identification of pathogens. The menu of models is being expanded to include other bacterial genera and species of clinical significance.

Pediatric Return Appointment Adherence for Child Welfare-Involved Children in Los Angeles California.

PubMed

Schneiderman, Janet U; Smith, Caitlin; Arnold-Clark, Janet S; Fuentes, Jorge; Kennedy, Andrea K

2016-02-01

This study of primarily Latino caregivers and Latino child welfare-involved children had the following aims: (1) explore the return appointment adherence patterns at a pediatric medical clinic; and (2) determine the relationship of adherence to return appointments and caregiver, child, and clinic variables. The sample consisted of caregivers of child welfare-involved children who were asked to make a pediatric outpatient clinic return appointment (N = 87). Predictors included caregiver demographics, child medical diagnoses and age, and clinic/convenience factors including distance from the clinic to caregiver's home, days until the return appointment, reminder telephone call, Latino provider, and additional specialty appointment. Predictors were examined using χ(2) and t tests of significance. Thirty-nine percent of all caregivers were nonadherent in returning for pediatric appointments. When return appointments were scheduled longer after the initial appointment, caregivers were less likely to bring children back for medical care. The 39 % missed return appointment rate in this study is higher than other similar pediatric populations. Better coordination between pediatricians and caregivers in partnership with child welfare case workers is needed to ensure consistent follow-up regarding health problems, especially when appointments are not scheduled soon after the initial appointment.

Evaluating mesenchymal stem cell therapy for sepsis with preclinical meta-analyses prior to initiating a first-in-human trial

PubMed Central

Lalu, Manoj M; Sullivan, Katrina J; Mei, Shirley HJ; Moher, David; Straus, Alexander; Fergusson, Dean A; Stewart, Duncan J; Jazi, Mazen; MacLeod, Malcolm; Winston, Brent; Marshall, John; Hutton, Brian; Walley, Keith R; McIntyre, Lauralyn

2016-01-01

Evaluation of preclinical evidence prior to initiating early-phase clinical studies has typically been performed by selecting individual studies in a non-systematic process that may introduce bias. Thus, in preparation for a first-in-human trial of mesenchymal stromal cells (MSCs) for septic shock, we applied systematic review methodology to evaluate all published preclinical evidence. We identified 20 controlled comparison experiments (980 animals from 18 publications) of in vivo sepsis models. Meta-analysis demonstrated that MSC treatment of preclinical sepsis significantly reduced mortality over a range of experimental conditions (odds ratio 0.27, 95% confidence interval 0.18–0.40, latest timepoint reported for each study). Risk of bias was unclear as few studies described elements such as randomization and no studies included an appropriately calculated sample size. Moreover, the presence of publication bias resulted in a ~30% overestimate of effect and threats to validity limit the strength of our conclusions. This novel prospective application of systematic review methodology serves as a template to evaluate preclinical evidence prior to initiating first-in-human clinical studies. DOI: http://dx.doi.org/10.7554/eLife.17850.001 PMID:27870924

Initial Virologic Response and HIV Drug Resistance Among HIV-Infected Individuals Initiating First-line Antiretroviral Therapy at 2 Clinics in Chennai and Mumbai, India

PubMed Central

Hingankar, Nitin K.; Thorat, Smita R.; Deshpande, Alaka; Rajasekaran, S.; Chandrasekar, C.; Kumar, Suria; Srikantiah, Padmini; Chaturbhuj, Devidas N.; Datkar, Sharda R.; Deshmukh, Pravin S.; Kulkarni, Smita S.; Sane, Suvarna; Reddy, D. C. S.; Garg, Renu; Jordan, Michael R.; Kabra, Sandhya; Paranjape, Ramesh S.

2012-01-01

Human immunodeficiency virus drug resistance (HIVDR) in cohorts of patients initiating antiretroviral therapy (ART) at clinics in Chennai and Mumbai, India, was assessed following World Health Organization (WHO) guidelines. Twelve months after ART initiation, 75% and 64.6% of participants at the Chennai and Mumbai clinics, respectively, achieved viral load suppression of <1000 copies/mL (HIVDR prevention). HIVDR at initiation of ART (P <.05) and 12-month CD4 cell counts <200 cells/μL (P <.05) were associated with HIVDR at 12 months. HIVDR prevention exceeded WHO guidelines (≥70%) at the Chennai clinic but was below the target in Mumbai due to high rates of loss to follow-up. Findings highlight the need for defaulter tracing and scale-up of routine viral load testing to identify patients failing first-line ART. PMID:22544202

Fluoroscopic guide wire manipulation of malfunctioning peritoneal dialysis catheters initially placed by interventional radiologists.

PubMed

Kwon, Young Ho; Kwon, Se Hwan; Oh, Joo Hyeong; Jeong, Kyung Hwan; Lee, Tae Won

2014-06-01

To assess the efficacy of fluoroscopic guide wire manipulation in patients with malfunctioning peritoneal dialysis (PD) catheters that were initially placed by interventional radiologists under fluoroscopic guidance. From January 2002 to April 2012, 52 patients (mean age, 52.8 y ± 2.10s; range, 12-79 y) with malfunctioning PD catheters in whom fluoroscopic guide wire manipulation was performed were retrospectively reviewed. Technical success, clinical success, and complications were evaluated. Technical success was defined as fluoroscopically verified, successful catheter repositioning and adequate dialysate drainage after the procedure. Clinical success was defined as maintenance of PD catheter function for at least 30 days after the manipulation. During the study period, 72 manipulations (68 initial manipulations and 4 remanipulations) for malfunctioning PD catheters were done. The technical success rate was 74% (50 of 68) for initial manipulations and 75% (3 of 4) for remanipulations. The overall clinical success rate was 47% (32 of 68) for initial manipulations and 0% (0 of 4) for remanipulations. The primary causes of catheter malfunction were extraluminal obstruction by omental wrapping or adhesions in 43 of 68 cases (63.2%) and catheter malposition in 25 of 68 (36.8%) cases. There were no procedure-related major complications. Fluoroscopic guide wire manipulation in patients with malfunctioning PD catheters initially placed by interventional radiologists is a simple procedure, an effective way of prolonging PD catheter life, and a recommended procedure before invasive surgical procedures. Copyright © 2014 SIR. Published by Elsevier Inc. All rights reserved.

The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia.

PubMed

Joshi, Kruti; Mao, Lian; Biondi, David M; Millet, Robert

2018-01-29

Outpatient facilities, such as community behavioral health organizations (CBHOs), play a critical role in the care of patients with serious mental illness, but there is a paucity of "real-world" patient outcomes data from this health care setting. Therefore, we conducted The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) trial, a real-world, prospective, noninterventional observational study of patients with mental illness treated at CBHOs across the United States. We describe demographic and clinical characteristics, antipsychotic therapy (APT) treatment patterns, and health care resource utilization in patients with schizophrenia undergoing medical care as usual. This study enrolled adults with schizophrenia or bipolar I disorder who initiated APT treatment at various time points: 1) within 8 weeks of initiating risperidone long-acting injectables (RLAIs) or other APTs except paliperidone palmitate (PP), 2) after more than 24 weeks of continuous RLAI treatment, or 3) at any time after initiating PP LAI treatment (schizophrenia only). Study assessments were performed via participant interview, medical chart abstraction, and clinical survey at enrollment and at month 12. A total of 1065 patients from 46 CBHOs were enrolled. Of these, 944 (88.6%) had a diagnosis of schizophrenia and 121 (11.4%) had bipolar I disorder. At enrollment, 599 (63.5%) of patients with schizophrenia were receiving RLAIs or PP LAI, 281 (29.8%) were receiving oral APTs, and 64 (6.8%) were receiving other injectable APTs. A number of differences in patient characteristics and outcomes were observed between patients in the LAI APT cohort and the oral APT cohort. Descriptive analyses from this observational study suggest differences in the patient characteristics, treatment patterns, and clinical and economic outcomes among those with schizophrenia treated at CBHOs with LAI APT or oral APTs. Additional analyses will be conducted to delineate the impact of LAI APT versus oral APTs on patient outcomes. Clinical Trial Registry: NCT01181960 . Registered 12 August 2010.

A nurse-led 'stop smoking' initiative.

PubMed

McGowan, E; MacAuley, D; Anderson, U

A one-week smoking awareness initiative and subsequent audit in a general practice are described. All patients attending morning surgery during the study period were offered the opportunity to discuss smoking habits at a smoking awareness clinic: 84 smokers attended. They were interviewed by the practice preventive care nurse who took a smoking history, monitored carbon monoxide (CO Hb) levels and offered a follow-up appointment. CO Hb provided immediate feedback on the effect of smoking and patients who smoked 20 or more cigarettes per day had an average CO Hb of 16.1 per cent. Fifteen per cent of smokers made a commitment to stop smoking and agreed to attend follow-up clinics. A random sample (50) of attenders at the initial Smoking Awareness Clinic (84) were followed up by questionnaire six months later. There were 29 replies (58 per cent); 19 patients (65 per cent) found the visit to the clinic helpful, 14 (48 per cent) reduced the number of cigarettes they smoked, and 11 (38 per cent) altered some other aspect of their lifestyle, of whom four modified their diet and four increased exercise. Five patients claimed they had given up smoking.

Getting right to the point: identifying Australian outpatients' priorities and preferences for patient-centred quality improvement in chronic disease care.

PubMed

Fradgley, Elizabeth A; Paul, Christine L; Bryant, Jamie; Oldmeadow, Christopher

2016-09-01

To identify specific actions for patient-centred quality improvement in chronic disease outpatient settings, this study identified patients' general and specific preferences among a comprehensive suite of initiatives for change. A cross-sectional survey was conducted in three hospital-based clinics specializing in oncology, neurology and cardiology care located in New South Wales, Australia. Adult English-speaking outpatients completed the touch-screen Consumer Preferences Survey in waiting rooms or treatment areas. Participants selected up to 23 general initiatives that would improve their experience. Using adaptive branching, participants could select an additional 110 detailed initiatives and complete a relative prioritization exercise. A total of 541 individuals completed the survey (71.1% consent, 73.1% completion). Commonly selected general initiatives, presented in order of decreasing priority (along with sample proportion), included: improved parking (60.3%), up-to-date information provision (15.0%), ease of clinic contact (12.9%), access to information at home (12.8%), convenient appointment scheduling (14.2%), reduced wait-times (19.8%) and information on medical emergencies (11.1%). To address these general initiatives, 40 detailed initiatives were selected by respondents. Initiatives targeting service accessibility and information provision, such as parking and up-to-date information on patient prognoses and progress, were commonly selected and perceived to be of relatively greater priority. Specific preferences included the need for clinics to provide patient-designated parking in close proximity to the clinic, information on treatment progress and test results (potentially in the form of designated brief appointments or via telehealth) and comprehensive and trustworthy lists of information sources to access at home. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The clinician's guide to composing effective business plans.

PubMed

Ettinger, Alan B; Blondell, Catherine

2011-01-01

In today's challenging healthcare environment, clinicians need to understand the fundamentals of financial analysis, which are the underpinnings of their clinical programs, especially when seeking administrative support for new initiatives. The business plan for new clinical program initiatives is composed of diverse elements such as the mission statement, market and competitive analyses, operations plan, and financial analysis. Armed with a basic knowledge of financial analysis of clinical programs, as well as forward-looking analysis of an initiative's added value, the healthcare provider can work much more effectively with administration in developing or creating new healthcare program initiatives.

A Study of the Intent to Fully Utilize Electronic Personal Health Records in the Context of Privacy and Trust

ERIC Educational Resources Information Center

Richards, Rhonda J.

2012-01-01

Government initiatives called for electronic health records for each individual healthcare consumer by 2014. The purpose of the initiatives is to provide for the common exchange of clinical information between healthcare consumers, healthcare providers, third-party payers and public healthcare officials. This exchange of healthcare information…

Vertical integration of teaching in Australian general practice--a survey of regional training providers.

PubMed

Stocks, Nigel P; Frank, Oliver; Linn, Andrew M; Anderson, Katrina; Meertens, Sarah

2011-06-06

To examine vertical integration of teaching and clinical training in general practice and describe practical examples being undertaken by Australian general practice regional training providers (RTPs). A qualitative study of all RTPs in Australia, mid 2010. All 17 RTPs in Australia responded. Eleven had developed some vertical integration initiatives. Several encouraged registrars to teach junior doctors and medical students, others encouraged general practitioner supervisors to run multilevel educational sessions, a few coordinated placements, linkages and support across their region. Three RTPs provided case studies of vertical integration. Many RTPs in Australia use vertical integration of teaching in their training programs. RTPs with close associations with universities and rural clinical schools seem to be leading these initiatives.

How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

PubMed

Naci, Huseyin; Ioannidis, John P A

2015-01-01

Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

Fluid Overload and Fluid Removal in Pediatric Patients on Extracorporeal Membrane Oxygenation Requiring Continuous Renal Replacement Therapy

PubMed Central

Selewski, David T; Cornell, Timothy T; Blatt, Neal B; Han, Yong Y; Mottes, Theresa; Kommareddi, Mallika; Gaies, Michael G; Annich, Gail M; Kershaw, David B; Shanley, Thomas P; Heung, Michael

2012-01-01

Objective In pediatric patients fluid overload (FO) at continuous renal replacement (CRRT) initiation is associated with increased mortality. The aim of this study was to characterize the association between fluid overload at CRRT initiation, fluid removal during CRRT, the kinetics of fluid removal and mortality in a large pediatric population receiving CRRT while on extracorporeal membrane oxygenation (ECMO). Design Retrospective chart review. Setting Tertiary children’s hospital Patients ECMO patients requiring CRRT from July 2006 to September 2010 Interventions None Measurements and Main Results Overall ICU survival was 34% for 53 patients that were initiated on CRRT while on ECMO during the study period. Median FO at CRRT initiation was significantly lower in survivors compared to non-survivors (24.5 vs. 38%, p=0.006). Median FO at CRRT discontinuation was significantly lower in survivors compared to non-survivors (7.1 vs. 17.5%, p=0.035). After adjusting for percent FO at CRRT initiation, age and severity of illness, the change in FO at CRRT discontinuation was not significantly associated with mortality (p=0.212). Models investigating the rates of fluid removal in different periods, age, severity of illness and fluid overload at CRRT initiation found that fluid overload at CRRT initiation was the most consistent predictor of survival. Conclusions Our data demonstrates an association between FO at CRRT initiation and mortality in pediatric patients receiving ECMO. The degree of FO at CRRT discontinuation is also associated with mortality, but appears to reflect the effect of FO at initiation. Furthermore, correction of FO to ≤ 10% was not associated with improved survival. These results suggest that intervening prior to the development of significant FO may be more clinically effective than attempting fluid removal after significant fluid overload has developed. Our findings suggest a role for earlier initiation of CRRT in this population, and warrant further clinical studies. PMID:22743776

Clinically Significant Change to Establish Benchmarks in Residential Drug and Alcohol Treatment Services

ERIC Educational Resources Information Center

Billingham, Daniel D.; Kelly, Peter J.; Deane, Frank P.; Crowe, Trevor P.; Buckingham, Mark S.; Craig, Fiona L.

2012-01-01

There is increasing emphasis on the use routine outcome assessment measures to inform quality assurance initiatives. The calculation of reliable and clinically significant change indices is one strategy that organizations could use to develop both internal and externally focused benchmarking processes. The current study aimed to develop reliable…

The Pursuit of a Collegial Model of Clinical Practice: The Story of One University

ERIC Educational Resources Information Center

Strieker, Toni S.; Lim, Woong; Hubbard, Daphne; Crovitz, Darren; Gray, Kimberly C.; Holbien, Marie; Steffen, Cherry

2017-01-01

This study addresses the urgent need for change in clinical experiences that better prepare teacher candidates to negotiate the changing landscape of educational and accreditation policies and practices affecting P-12 classrooms. Specifically, the article examines the impact of a comprehensive 4-year initiative to transform traditional student…

76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... proof of principle and initial clinical safety data before the device design is finalized. This draft... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.... Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle...

Computer-Based Intepretation of the Marital Satisfaction Inventory: Use in Treatment Planning.

ERIC Educational Resources Information Center

Snyder, Douglas K.; And Others

1988-01-01

Describes computer-based interpretive system for Marital Satisfaction Inventory (MSI) and application in initial phases of clinical assessment and treatment planning. Provides case study. Compares clinical findings at intake with MSI profiles for one couple obtained at termination and follow-up. Considers strengths and limitations of self-report…

Inhaled corticosteroids and the occurrence of oral candidiasis: a prescription sequence symmetry analysis.

PubMed

van Boven, Job F M; de Jong-van den Berg, Lolkje T W; Vegter, Stefan

2013-04-01

The primary aim of the study was to gain insight into the relative risk of clinically relevant oral candidiasis following inhaled corticosteroid (ICS) initiation over time. A secondary aim was to analyse the influence of patient characteristics and co-medication on the occurrence of this adverse effect. Drug prescription data from 1994 to 2011 were retrieved from the IADB.nl database. To study the influence of ICS use on occurrence of oral candidiasis, a prescription symmetry analysis was used, including patients using medication for oral candidiasis up to 1 year before or after ICS initiation. The relative risk was calculated by dividing the number of patients receiving medication for oral candidiasis after ICS initiation by the number of patients receiving the same medication before ICS initiation. Sub-analyses were conducted to compare the relative risks at several time points after ICS initiation and to account for therapy persistence by only including chronic users of ICS. A multivariate logistic regression model was used to identify predictive factors. A total of 52,279 incident users of ICS therapy were identified, of which 1,081 received medication for oral candidiasis up to 1 year before or after ICS initiation. A total of 701 patients received medication for oral candidiasis after ICS initiation, while 361 received these medications in the reversed sequence, resulting in a sequence ratio (SR) of 1.94 (95 % CI 1.71-2.21). In the first 3 months after ICS initiation, the SR was 2.72 (95 % CI 2.19-3.38) and then decreased to 1.47 (95 % CI 1.11-1.95) 9-12 months after ICS initiation. Predictive factors were higher daily dose of ICS and concomitant use of oral corticosteroids. This study found a significant and clinically relevant increased number of patients receiving medication for oral candidiasis in the first year after therapy initiation with ICS. Relative risk is highest in the first 3 months, but remains increased up to at least 1 year after ICS initiation. This study stresses the need for patient education and inhalation instruction.

Characteristics of clients who access mobile compared to clinic HIV counselling and testing services: a matched study from Cape Town, South Africa.

PubMed

Meehan, Sue-Ann; Naidoo, Pren; Claassens, Mareli M; Lombard, Carl; Beyers, Nulda

2014-12-20

Studies within sub-Saharan African countries have shown that mobile services increase uptake of HIV counselling and testing (HCT) services when compared to clinics and are able to access different populations, but these have included provider-initiated HCT in clinics. This study aimed to compare the characteristics of clients who self-initiated HCT at either a mobile or a clinic service in terms of demographic and socio-economic variables, also comparing reasons for accessing a particular health service provider. This study took place in eight areas around Cape Town. A matched design was used with one mobile HCT service matched with one or more clinics (offering routine HCT services) within each of the eight areas. Adult clients who self-referred for an HIV test within a specified time period at either a mobile or clinic service were invited to participate in the study. Data were collected between February and April 2011 using a questionnaire. Summary statistics were calculated for each service type within a matched pair and differences of outcomes from pairs were used to calculate effect sizes and 95% confidence intervals. 1063 participants enrolled in the study with 511 from mobile and 552 from clinic HCT services. The proportion of males accessing mobile HCT significantly exceeded that of clinic HCT (p < 0.001). The mean age of participants attending mobile HCT was higher than clinic participants (p = 0.023). No significant difference was found for socio-economic variables between participants, with the exception of access to own piped water (p = 0.029). Participants who accessed mobile HCT were significantly more likely to report that they were just passing, deemed an "opportunistic" visit (p = 0.014). Participants who accessed clinics were significantly more likely to report the service being close to home or work (p = 0.035). An HCT strategy incorporating a mobile HCT service, has a definite role to play in reaching those population groups who do not typically access HCT services at a clinic, especially males and those who take advantage of the opportunity to test. Mobile HCT services can complement clinic services.

Initial therapeutic strategy of invasive candidiasis for intensive care unit patients: a retrospective analysis from the China-SCAN study.

PubMed

Cui, Na; Wang, Hao; Su, Longxiang; Qiu, Haibo; Li, Ruoyu; Liu, Dawei

2017-01-23

To investigate the impact of initial antifungal therapeutic strategies on the prognosis of invasive Candida infections (ICIs) in intensive care units (ICUs) in China. A total of 306 patients with proven ICIs in the China-SCAN study were analyzed retrospectively. Empiric, pre-emptive, and targeted therapy were adopted based on starting criteria including clinical, microbiological, and other conventional prediction rules. The primary outcome was hospital mortality and the secondary endpoints were duration days in ICU and duration days in hospital. The global responses (clinical and microbiological) at the end of the empirical therapy were also assessed. A total of 268/306 (87.6%) ICI patients received antifungal therapy, including 142/268 (53.0%) initial empirical therapy, 53/268 (19.8%) initial pre-emptive therapy, and 73/268 (27.2%) initial targeted therapy. Compared with the initial empirical antifungal therapy and targeted antifungal therapy, patients with initial pre-emptive antifungal therapy had significantly less clinical remission [11/53 (21.2%) vs. 61/142 (43.3%) vs. 22/73 (30.1%), P = 0.009], higher ICU [26/53 (57.8%) vs. 42/142 (32.2%) vs. 27/73 (43.5%), P = 0.008] and hospital mortality [27/53 (60.0%) vs. 43/142 (32.8%) vs. 29/73 (46.8%), P = 0.004] and more microbiological persistence [9/53 (17.0%) vs. 6/142 (4.2%) vs. 9/73 (12.3%), P = 0.011]. Kaplan-Meier survival analysis revealed that ICI patients with initial pre-emptive antifungal therapy and targeted antifungal therapy were associated with reduced hospital duration compared with patients with initial empirical antifungal therapy after confirmation of fungal infection (log-rank test: P = 0.021). Multivariate regression analysis provided evidence that initial empirical antifungal therapy was an independent predictor for DECREASING the hospital mortality in ICI patients on ICU admission and at ICI diagnosis (odds ratio 0.327, 95% confidence interval 0.160-0.667, P = 0.002; odds ratio 0.351, 95% confidence interval 0.168-0.735, P = 0.006). The initial therapeutic strategy for invasive candidiasis was independently associated with hospital mortality. Prompt empirical antifungal therapy could be critical to decrease early hospital mortality. Clinicaltrials.gov NCT01253954 (retrospectively registration date: December 3, 2010).

Determinants of weight evolution among HIV-positive patients initiating antiretroviral treatment in low resource settings

PubMed Central

Huis in ‘t Veld, D.; Balestre, E.; Buyze, J; Menten, J.; Jaquet, A.; Cooper, D.A.; Dabis, F.; Yiannoutsos, C. T.; Diero, L.; Mutevedzi, P.; Fox, M.P.; Messou, E.; Hoffmann, C.J.; Prozesky, H.W.; Egger, M.; Hemingway-Foday, J.J.; Colebunders, R.

2015-01-01

Background In resource limited settings clinical parameters, including body weight changes, are used to monitor clinical response. Therefore we studied body weight changes in patients on antiretroviral treatment (ART) in different regions of the world. Methods Data were extracted from the “International Epidemiologic Databases to Evaluate AIDS”, a network of ART programmes that prospectively collects routine clinical data. Adults on ART from the Southern-, East-, West- and Central African and the Asia-Pacific regions were selected from the database if baseline data on body weight, gender, ART regimen and CD4 count were available. Body weight change over the first two years and the probability of body weight loss in the second year were modelled using linear mixed models and logistic regression respectively. Results Data from 205,571 patients were analysed. Mean adjusted body weight change in the first 12 months was higher in patients started on tenofovir and/or efavirenz; in patients from Central, West and East Africa, in men, and in patients with a poorer clinical status. In the second year of ART it was greater in patients initiated on tenofovir and/or nevirapine, and for patients not on stavudine, in women, in Southern Africa and in patients with a better clinical status at initiation. Stavudine in the initial regimen was associated with a lower mean adjusted body weight change and with weight loss in the second treatment year. Conclusion Different ART regimens have different effects on body weight change. Body weight loss after one year of treatment in patients on stavudine might be associated with lipoatrophy. PMID:26375465

An Examination of New York State's Integrated Primary and Mental Health Care Services for Adults with Serious Mental Illness.

PubMed

Scharf, Deborah M; Breslau, Joshua; Hackbarth, Nicole Schmidt; Kusuke, Daniela; Staplefoote, B Lynette; Pincus, Harold Alan

2014-12-30

The poor physical health of adults with serious mental illnesses is a public health crisis. Greater integration of mental health and primary medical care services at the clinic and system levels could address this need. In New York state, there are several ongoing initiatives that promote integrated care for adults with serious mental illness, provided or coordinated by community mental health center staff. This study examines three initiatives. Data were collected by RAND through site visits and surveys of mental health clinic administrators and associated professionals. Results showed that Primary and Behavioral Health Care Integration grantees developed infrastructure that supported a broad scope of primary and preventive health care services; these broad changes appeared to contribute to clinic-wide culture shifts toward integration and shared accountability for consumers' "whole person" health. Clinics participating in the Medicaid Incentive tended to implement only those services for which they could bill, which resulted in newly identified consumer physical health care needs but did not help consumers to connect to physical health care services. Finally, while administrators and providers were optimistic that Medicaid Health Homes have potential to improve access to care for adults with serious mental illness, the newness of the initiative made it difficult to assess the degree to which Health Home networks would meet these goals. We conclude with recommendations to state policymakers, clinical providers, and technical assistance providers and recommendations for future research, all designed to strengthen New York state's integrated care initiatives for adults with serious mental illness.

Understanding factors, outcomes and reasons for loss to follow-up among women in Option B+ PMTCT programme in Lilongwe, Malawi.

PubMed

Tweya, Hannock; Gugsa, Salem; Hosseinipour, Mina; Speight, Colin; Ng'ambi, Wingston; Bokosi, Mphatso; Chikonda, Janet; Chauma, Annie; Khomani, Patricia; Phoso, Malocho; Mtande, Tiwonge; Phiri, Sam

2014-11-01

To assess factors, outcomes and reasons for loss to follow-up (LTFU) among pregnant and breastfeeding women initiated on a lifelong antiretroviral therapy (ART) for PMTCT in a large antenatal clinic in Malawi. We identified all pregnant and breastfeeding women who were initiated on ART between September 2011 and September 2013 and had missed their clinic appointment by at least 3 weeks at Bwaila Hospital, the largest antenatal clinic in Malawi. These women were traced by phone or home visits. Their true status and reasons for ART discontinuation were documented during tracing. A total of 2930 women started ART for PMTCT; 2458 (84%) pregnant and 472 (16%) breastfeeding, of which, 577 (20%) missed a scheduled clinic appointment. LTFU was associated with younger age, being pregnant, and earlier year of ART initiation. We successfully traced 229 (40%), of whom, 10 (4%) had died. Of the 219 women found alive, 118 (54%) had stopped taking ARV drugs, 67 (30%) had self-transferred to another ART clinic, 13 (6%) had collected drugs from other sources, 9 (4%) had treatment interruptions and 12 (5%) had other outcomes. Reasons cited for stopping ART were travel (38%), lack of transport money (16%), not understanding the initial ARV education session (10%), being too weak/sick (10%), ARV side effects (10%) and other reasons. Approximately half of the women who were traced were taking ARVs. The study emphasises the need for enhanced post-test counselling strategies, ongoing psychosocial support, provision of incentives and further decentralisation efforts of PMTCT services. © 2014 John Wiley & Sons Ltd.

Cancer risk in HIV patients with incomplete viral suppression after initiation of antiretroviral therapy.

PubMed

Lee, Jennifer S; Cole, Stephen R; Achenbach, Chad J; Dittmer, Dirk P; Richardson, David B; Miller, William C; Mathews, Christopher; Althoff, Keri N; Moore, Richard D; Eron, Joseph J

2018-01-01

Cancer causes significant morbidity and mortality among HIV patients in the US due to extended life expectancy with access to effective antiretroviral therapy. Low, detectable HIV RNA has been studied as a risk factor for adverse health outcomes, but its clinical impact on cancer risk remains unclear. The objective of this study was to determine whether HIV RNA <1,000 copies/mL six months after starting therapy was associated with 10-year first cancer risk. We followed 7,515 HIV therapy initiators from a US-based multicenter clinical cohort from 1998 to 2014. We used nonparametric multiple imputation to account for viral loads that fell below assay detection limits, and categorized viral loads six months after therapy initiation into four groups: <20, 20-199, 200-999, and >999 copies/mL. We calculated estimates of the cumulative incidence of cancer diagnosis, accounting for death as a competing event. Inverse probability of exposure and censoring weights were used to control for confounding and differential loss to follow up, respectively. Crude 10-year first cancer risk in the study sample was 7.03% (95% CI: 6.08%, 7.98%), with the highest risk observed among patients with viral loads between 200 and 999 copies/mL six months after ART initiation (10.7%). After controlling for baseline confounders, 10-year first cancer risk was 6.90% (95% CI: 5.69%, 8.12%), and was similar across viral load categories. Overall risk of first cancer was not associated with incomplete viral suppression; however, cancer remains a significant threat to HIV patients after treatment initiation. As more HIV patients gain access to treatment in the current "treat all" era, occurrences of incomplete viral suppression will be observed more frequently in clinical practice, which supports continued study of the role of low-level HIV RNA on cancer development.

Results of a prospective clinical study on the diagnostic performance of standard magnetic resonance imaging in comparison to a combination of 3T MRI and additional CT imaging in Kienböck's disease.

PubMed

Stahl, Stephane; Hentschel, Pascal; Ketelsen, Dominik; Grosse, Ulrich; Held, Manuel; Wahler, Theodora; Syha, Roland; Schaller, Hans-Eberhard; Nikolaou, Konstantin; Grözinger, Gerd

2017-05-01

This prospective clinical study examined standard wrist magnetic resonance imaging (MRI) examinations and the incremental value of computed tomography (CT) in the diagnosis of Kienböck's disease (KD) with regard to reliability and precision in the different diagnostic steps during diagnostic work-up. Sixty-four consecutive patients referred between January 2009 and January 2014 with positive initial suspicion of KD according to external standard wrist MRI were prospectively included (step one). Institutional review board approval was obtained. Clinical examination by two handsurgeons were followed by wrist radiographs (step two), ultrathin-section CT, and 3T contrast-enhanced MRI (step three). Final diagnosis was established in a consensus conference involving all examiners and all examinations results available from step three. In 12/64 patients, initial suspicion was discarded at step two and in 34/64 patients, the initial suspicion of KD was finally discarded at step three. The final external MRI positive predictive value was 47%. The most common differential diagnoses at step three were intraosseous cysts (n=15), lunate pseudarthrosis (n=13), and ulnar impaction syndrome (n=5). A correlation between radiograph-based diagnoses (step two) with final diagnosis (step three) showed that initial suspicion of stage I KD had the lowest sensitivity for correct diagnosis (2/11). Technical factors associated with a false positive external MRI KD diagnosis were not found. Standard wrist MRI should be complemented with thin-section CT, and interdisciplinary interpretation of images and clinical data, to increase diagnostic accuracy in patients with suspected KD. Copyright © 2017. Published by Elsevier B.V.

Introducing clinical supervision across Western Australian public mental health services.

PubMed

Taylor, Monica; Harrison, Carole A

2010-08-01

Retention and recruitment of the mental health nursing workforce is a critical issue in Australia and more specifically in Western Australia (WA), partly due to the isolation of the state. It has been suggested that these workforce issues might be minimized through the introduction of clinical supervision within WA mental health services, where, historically, it has been misunderstood and viewed with caution by mental health nurses. This may have been partly due to a lack of understanding of clinical supervision, its models, and its many benefits, due to a paucity of information delivered into initial nurse education programs. The aim of this pilot project is to explore and evaluate the introduction of clinical supervision in WA public mental health services. A quantitative approach informed the study and included the use of an information gathering survey initially, which was followed with evaluation questionnaires. The findings show that education can increase the uptake of clinical supervision. Further, the findings illustrate the importance of linking clinicians from all professional groups via a clinical supervision web-based database.

Prevalence of prescription opioid use disorder among chronic opioid therapy patients after health plan opioid dose and risk reduction initiatives.

PubMed

Von Korff, Michael; Walker, Rod L; Saunders, Kathleen; Shortreed, Susan M; Thakral, Manu; Parchman, Michael; Hansen, Ryan N; Ludman, Evette; Sherman, Karen J; Dublin, Sascha

2017-08-01

No studies have assessed the comparative effectiveness of guideline-recommended interventions to reduce risk of prescription opioid use disorder among chronic opioid therapy (COT) patients. We compared the prevalence of prescription opioid use disorder among COT patients from intervention clinics that had implemented opioid dose and risk reduction initiatives for more than 4 years relative to control clinics that had not. After a healthcare system in Washington State implemented interventions to reduce opioid dose and risks, we surveyed 1588 adult primary care COT patients to compare the prevalence of prescription opioid use disorder among COT patients from the intervention and control clinics. Intervention clinics managed COT patients at lower COT doses and with more consistent use of risk reduction practices. Control clinics cared for similar COT patients but prescribed higher opioid doses and used COT risk reduction practices inconsistently. Prescription opioid use disorder was assessed with the Psychiatric Research Interview for Substance and Mental Disorders. The prevalence of prescription opioid use disorder was 21.5% (95% CI=18.9% to 24.4%) among COT patients in the intervention clinics and 23.9% (95% CI=20.5% to 27.6%) among COT patients in the control clinics. The adjusted relative risk of prescription opioid use disorder was 1.08 (95% CI=0.89, 1.32) among the control clinic patients relative to the intervention clinic patients. Long-term implementation of opioid dose and risk reduction initiatives was not associated with lower rates of prescription opioid use disorder among prevalent COT patients. Extreme caution should be exercised by clinicians considering COT for patients with chronic non-cancer pain until benefits of this treatment and attendant risks are clarified. Copyright © 2017 Elsevier B.V. All rights reserved.

Liberating the Oppressed: Research Knowledge Differentials and Ethical Investigation in Special Operations Forces Clinical Science.

PubMed

Kemplin, Kate Rocklein; Bowling, F Young

Special Operations Forces (SOF) medics do not have preparation in research knowledge that enables them to independently initiate or generate their own studies. Thus, medics rely on evidence generated by others, who are removed from medics' practice environment. Here, salient literature on research self-efficacy and the genesis of institutional review boards (IRBs) are reviewed and interpreted for contextual applications to medics' practice and initiation of studies. More publications delving into research methods are warranted to promote medics' participation and initiation of selfdirected scientific investigation, in collaboration with research scientists. 2017.

Trends in baseline CD4 cell counts and risk factors for late antiretroviral therapy initiation among HIV-positive patients in Shanghai, a retrospective cross-sectional study.

PubMed

Sun, Jianjun; Liu, Li; Shen, Jiayin; Chen, Panpan; Lu, Hongzhou

2017-04-19

There are few studies focus on the factors underlying the late initiation of ART in China. We analyzed the trends in the median CD4 cell counts among different patient groups over time and the risk factors for the late initiation of ART in Shanghai, China. A retrospective cross-sectional survey was made in the Department of Infectious Disease of Shanghai Public Health Clinical Center which is a designated diagnosis and treatment center for HIV-positive patients in Shanghai during the period of January 1st, 2008--June 30th, 2014. Late ART initiation was defined as a CD4 cell count <200 cells/mm 3 or having a clinical AIDS diagnosis prior to ART initiation. Trends in the median CD4 cell count at ART initiation and the proportion of late ART initiation by year were evaluated using Spearman's correlations and Chi-squared methods, respectively. We used a logistic regression model to analyze the risk factors for late ART initiation. The related factors collected in the multivariate model were the patient's age, gender, infection routes and marital status. A total of 3796 patients were analyzed in this study, with a median baseline CD4 cell count of 205 cells/mm 3 [interquartile range: 75-287]. The median CD4 cell counts of patients initiating ART late increased from 76 cells/mm 3 in 2008 to 103 cells/mm 3 in 2014 (p < 0.001), and the proportion of late ART initiation decreased from 80% to 45% (p < 0.001). The risk factors for late ART initiation were male gender, heterosexual transmission and older age (>30 years) (p < 0.001). Notable improvements were made in the median CD4 cell count at ART initiation and the proportion of late ART initiation from 2008 to 2014. However, persons with high risk of HIV exposure who are male, older even heterosexual orientation should be given more opportunities to receive frequently screening, earlier diagnoses and timely treatment.

Induced pluripotent stem cells--alchemist's tale or clinical reality?

PubMed

Rashid, S Tamir; Vallier, Ludovic

2010-08-13

Following Shinya Yamanaka's first report describing the reprogramming of fibroblasts into stem cells over three years ago, some sceptics initially drew analogies between this new field of research and the quasi-mystical practice of 'alchemy'. Unlike the alchemist, however, stem cell researchers have rigorously tested and repeated experiments, proving their very own brand of cellular 'alchemy' to be a reality, with potentially massive implications for the study of human biology and clinical medicine. These investigations have resulted in an explosion of related publications and initiated the field of stem cell research known as 'induced pluripotency'. In this review, we give an account of the historical development, current technologies and potential clinical applications of induced pluripotency and conclude with a perspective on the possible future directions for this dynamic field.

Physical Activity Level and Symptom Duration Are Not Associated After Concussion.

PubMed

Howell, David R; Mannix, Rebekah C; Quinn, Bridget; Taylor, J Andrew; Tan, Can Ozan; Meehan, William P

2016-04-01

Physical rest after a concussion has been described as a key component in the management of the injury. Evidence supporting this recommendation, however, is limited. To examine the association between physical activity and symptom duration in a cohort of patients after a concussion. Cohort study; Level of evidence, 2. This study included 364 patients who were diagnosed with a concussion, were seen by a physician within 3 weeks of injury, and completed a questionnaire at the initial clinic visit. The questionnaire assessed the postconcussion symptom scale (PCSS) score, previous number of concussions, presence of the loss of consciousness or amnesia at the time of injury, and prior treatment for headaches. During each follow-up clinic visit, physical activity level was self-reported. A Cox proportional hazard model was constructed to determine the association between symptom duration, initial clinic visit responses, and self-reported physical activity level after the injury. Study participants ranged in age from 8 to 27 years (mean age, 15.0 years) and had sustained a mean of 0.8 prior concussions; 222 patients (61%) were male. On initial examination, the mean PCSS score was 34.7. The mean symptom duration was 48.9 days after the injury. Among the variables included in the model, initial PCSS score and female sex were independently associated with symptom duration, while physical activity level after the injury was not. For participants aged between 13 and 18 years, however, higher levels of physical activity after the injury were associated with a shorter symptom duration. Results from this study indicate that physical activity after the injury may not be universally detrimental to the recovery of concussion symptoms. © 2016 The Author(s).

Vocal fold pseudocyst: results of 46 cases undergoing a uniform treatment algorithm.

PubMed

Estes, Christine; Sulica, Lucian

2014-05-01

To describe treatment results and identify predictors of the need for surgical intervention in patients with vocal fold pseudocyst. Retrospective cohort study with longitudinal followup via survey. Clinical records were reviewed for demographic information, VHI-10 score, and degree of severity of dysphonia. Videostroboscopic examinations were evaluated for presence of vocal fold pseudocyst, along with additional clinical variables, including laterality, reactive lesion, paresis, varix, and hemorrhage. Follow-up surveys were sent to all participants to evaluate current VHI-10 score and degree of vocal limitation. Results were analyzed to determine predictors of surgery and recurrence of pathology. Forty-six patients (41F:5M) with pseudocyst (40 unilateral: 6 bilateral) were reviewed. Twenty-three (50%) had reactive lesions, nineteen (41%) had paresis by clinical criteria, 10 (22%) had varices, and 6 (13%) had hemorrhage on examination. All underwent initial behavioral management (2-12 sessions of voice therapy; mean of 8 sessions). Seventeen (37%) eventually required surgical intervention. No demographic or clinical variables proved predictive of surgical intervention. Follow-up surveys were completed by 63% of patients, and 79% agreed with the statement that they were not professionally limited by their voices. This experience supports behavioral management as an initial intervention in patients with pseudocyst, sufficient by itself to restore vocal function in approximately two out of three patients. Neither initial severity nor any of the studied clinical findings predicted the need for surgery. The large majority of patients with pseudocyst are able to be treated effectively without impact in their professional function. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Sustainability of the integrated chronic disease management model at primary care clinics in South Africa

PubMed Central

Asmall, Shaidah

2016-01-01

Background An integrated chronic disease management (ICDM) model consisting of four components (facility reorganisation, clinical supportive management, assisted self-supportive management and strengthening of support systems and structures outside the facility) has been implemented across 42 primary health care clinics in South Africa with a view to improve the operational efficiency and patient clinical outcomes. Aim The aim of this study was to assess the sustainability of the facility reorganisation and clinical support components 18 months after the initiation. Setting The study was conducted at 37 of the initiating clinics across three districts in three provinces of South Africa. Methods The National Health Service (NHS) Institute for Innovation and Improvement Sustainability Model (SM) self-assessment tool was used to assess sustainability. Results Bushbuckridge had the highest mean sustainability score of 71.79 (95% CI: 63.70–79.89) followed by West Rand Health District (70.25 (95% CI: 63.96–76.53)) and Dr Kenneth Kaunda District (66.50 (95% CI: 55.17–77.83)). Four facilities (11%) had an overall sustainability score of less than 55. Conclusion The less than optimal involvement of clinical leadership (doctors), negative staff behaviour towards the ICDM, adaptability or flexibility of the model to adapt to external factors and infrastructure limitation have the potential to negatively affect the sustainability and scale-up of the model. PMID:28155314

Clinical response to chemotherapy in locally advanced breast cancer was not associated with several polymorphisms in detoxification enzymes and DNA repair genes.

PubMed

Saadat, Mostafa; Khalili, Maryam; Nasiri, Meysam; Rajaei, Mehrdad; Omidvari, Shahpour; Saadat, Iraj

2012-03-02

The main aim of the present study was to investigate the association between several genetic polymorphisms (in glutathione S-transferase members and DNA repair genes) and clinical response to chemotherapy in locally advanced breast cancer. A sequential series of 101 patients were prospectively included in this study. Clinical assessment of treatment was accomplished by comparing initial tumor size with preoperative tumor size using revised RECIST guideline (version 1.1). Clinical response was regarded as a response or no response. There was no difference between non-responders and responders for the prevalence of genotypes of the study polymorphisms. Copyright © 2012 Elsevier Inc. All rights reserved.

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

PubMed

Cozzi, Emanuele; Tallacchini, Mariachiara; Flanagan, Enda B; Pierson, Richard N; Sykes, Megan; Vanderpool, Harold Y

2009-01-01

The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.

Integrating clinical performance improvement across physician organizations: the PhyCor experience.

PubMed

Loeppke, R; Howell, J W

1999-02-01

There is a paucity of literature describing the implementation of clinical performance improvement (CPI) efforts across geographically dispersed multispecialty group practices and independent practice associations. PhyCor, a physician management company based in Nashville, Tennessee, has integrated CPI initiatives into its operating infrastructure. PhyCor CPI INITIATIVES: The strategic framework guiding PhyCor's CPI initiatives is built around a physician-driven, patient-centered model. Physician/administrator leadership teams develop and implement a clinical and financial strategic plan for performance improvement; adopt local clinical and operational performance indicators; and agree on and gain consensus with local physician champions to engage in CPI initiatives. The area/regional leadership councils integrate and coordinate regional medical management and CPI initiatives among local groups and independent practice associations. In addition to these councils and a national leadership council, condition-specific care management councils have also been established. These councils develop condition-specific protocols and outcome measures and lead the implementation of CPI initiatives at their own clinics. Key resources supporting CPI initiatives include information/knowledge management, education and training, and patient education and consumer decision support. Localized efforts in both the asthma care and diabetes management initiatives have led to some preliminary improvements in quality of care indicators. Physician leadership and strategic vision, CPI-oriented organizational infrastructure, broad-based physician involvement in CPI, providing access to performance data, parallel incentives, and creating a sense of urgency for accelerated change are all critical success factors to the implementation of CPI strategies at the local, regional, and national levels.

A time motion study in the immunization clinic of a tertiary care hospital of kolkata, west bengal.

PubMed

Chattopadhyay, Amitabha; Ghosh, Ritu; Maji, Sucharita; Ray, Tapobroto Guha; Lahiri, Saibendu Kumar

2012-01-01

A time and motion study is used to determine the amount of time required for a specific activity, work function, or mechanical process. Few such studies have been reported in the outpatient department of institutions, and such studies based exclusively on immunization clinic of an institute is a rarity. This was an observational cross sectional study done in the immunization clinic of R.G. Kar Medical College, Kolkata, over a period of 1 month (September 2010). The study population included mother/caregivers attending the immunization clinics with their children. The total sample was 482. Pre-synchronized stopwatches were used to record service delivery time at the different activity points. Median time was the same for both initial registration table and nutrition and health education table (120 seconds), but the vaccination and post vaccination advice table took the highest percentage of overall time (46.3%). Maximum time spent on the vaccination and post vaccination advice table was on Monday (538.1 s) and nutritional assessment and health assessment table took maximum time on Friday (217.1 s). Time taken in the first half of immunization session was more in most of the tables. The goal for achieving universal immunization against vaccine-preventable diseases requires multifaceted collated response from many stakeholders. Efficient functioning of immunization clinics is therefore required to achieve the prescribed goals. This study aims to initiate an effort to study the utilization of time at a certain health care unit with the invitation of much more in depth analysis in future.

Lupus pneumonitis as the initial presentation of systemic lupus erythematosus: case series from a single institution.

PubMed

Wan, S A; Teh, C L; Jobli, A T

2016-11-01

Objective The aim of this study was to examine the clinical features, treatment and outcome of systemic lupus erythematosus (SLE) patients in our centre who presented with lupus pneumonitis as the initial manifestation. Methods We performed a retrospective review of all patients who presented with lupus pneumonitis during the initial SLE manifestation from March 2006 to March 2015. Results There were a total of five patients in our study who presented with fever and cough as the main clinical features. All patients had pulmonary infiltrates on chest radiographs. High-resolution computed tomography, which was performed in two patients, showed ground glass opacities with patchy consolidations bilaterally. All patients received high-dose steroids, 80% received intravenous cyclophosphamide and 60% received intravenous immunoglobulin. Two patients died from severe lupus pneumonitis within 2 weeks of admission despite treatment with ventilation, steroids, cyclophosphamide and intravenous immunoglobulin. Conclusions Acute lupus pneumonitis is an uncommon presentation of SLE. Mortality in this case series is 40%.

[Current Status and Future Perspectives of SCRUM-Japan].

PubMed

Ohtsu, Atsushi; Goto, Koichi; Yoshino, Takayuki; Okamoto, Wataru; Tsuchihara, Katsuya

2017-08-01

SCRUM-Japan was launched as a nation-wide genome screening consortium for recruiting patients to 35 sponsor-/investigator- initiated registration trials in collaboration with 15 pharmaceutical companies and 240 hospitals. During the first period between February 2015 and March 2017, a total of 4,805 patients have been enrolled. Genomic profiling of each cancer were analyzed and newdrug applications of label expansion are in preparation based on the results of several registration studies including investigator-initiated trial of vandetanib for RET fusion gene positive non-small cell lung cancer. In addition, on-time clinical-genome data sharing with industries and academic institutions and prospective cohort registry for new drug evaluation as a historical control data have already initiated, which will facilitate new agent development in Japan. In the second period started from April 2017, new studies using cutting-edge liquid biopsy and immune-genome panel for precision medi- cine will start soon. These efforts are attempted towards a leading group for innovative clinical/translations researches in the world.

Radiosensitivity of cancer-initiating cells and normal stem cells (or what the Heisenberg uncertainly principle has to do with biology).

PubMed

Woodward, Wendy Ann; Bristow, Robert Glen

2009-04-01

Mounting evidence suggests that parallels between normal stem cell biology and cancer biology may provide new targets for cancer therapy. Prospective identification and isolation of cancer-initiating cells from solid tumors has promoted the descriptive and functional identification of these cells allowing for characterization of their response to contemporary cancer therapies, including chemotherapy and radiation. In clinical radiation therapy, the failure to clinically eradicate all tumor cells (eg, a lack of response, partial response, or nonpermanent complete response by imaging) is considered a treatment failure. As such, biologists have explored the characteristics of the small population of clonogenic cancer cells that can survive and are capable of repopulating the tumor after subcurative therapy. Herein, we discuss the convergence of these clonogenic studies with contemporary radiosensitivity studies that use cell surface markers to identify cancer-initiating cells. Implications for and uncertainties regarding incorporation of these concepts into the practice of modern radiation oncology are discussed.

The worsening factors of dengue hemorrhagic fever (DHF) based on cohort study with nested case-control in a tertiary hospital

NASA Astrophysics Data System (ADS)

Lardo, S.; Soesatyo, M. H. N. E.; Juffrie; Umniyati, S. R.

2018-03-01

The clinical pathway of DHF has a broad pathophysiological and pathogenesis spectrum. Clinical and laboratory characteristics are some of the parameters to determine the factors that contribute to the worsening of the disease. The objective of this study is to determine the clinical and laboratory characteristics which contribute to the worsening of DHF. The study had been conducted from January 2012-December 2014 at the general ward of the Internal Medicine Department, Indonesia Army Central Hospital Gatot Soebroto. There were 101 male patients (64.7%) and 55 female patients (35.3 %) ages ranging from 14 - 62 years old. The diagnosis was divided into: 124 patients DHF grade I, 6 DHF grade II, 20 DHF grade III and 6 with dengue shock syndrome (DSS) patients. Clinically and statistically, there were 4 variables apparently found with the severity of DHF, as follows: decreased appetite with p = 0.007 (OR 4.87), hepatomegaly with p = 0.009 (OR 27.00), systolic blood pressure with p = 0.037 (OR 0.95), and initial thrombocyte with p = 0.000 (OR 0.97). This cohort and nested case-control study found that worsening of DHF is related with decreased appetite, hepatomegaly, systolic blood pressure and initial thrombocyte count.

Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

PubMed

Morrison, Susan; John-Stewart, Grace; Egessa, John J; Mubezi, Sezi; Kusemererwa, Sylvia; Bii, Dennis K; Bulya, Nulu; Mugume, Francis; Campbell, James D; Wangisi, Jonathan; Bukusi, Elizabeth A; Celum, Connie; Baeten, Jared M

2015-01-01

During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study.

PubMed

Walter, Daisy; Laleman, Wim; Jansen, Jeroen M; van Milligen de Wit, A W M; Weusten, Bas L; van Boeckel, Petra G; Hirdes, Meike M; Vleggaar, Frank P; Siersema, Peter D

2015-05-01

Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliary strictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent. To evaluate the efficacy of a novel FCSEMS with antimigration features. Prospective cohort study. Five hospitals in the Netherlands and Belgium. Consecutive patients with BBS. FCSEMS placement for 3 months. Initial and long term clinical success, stent migration rate and safety. Thirty-eight patients (24 men; mean age, 53 ± 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common. Nonrandomized study design. Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Therapy of endocrine disease: outcomes in patients with Cushing's disease undergoing transsphenoidal surgery: systematic review assessing criteria used to define remission and recurrence.

PubMed

Petersenn, Stephan; Beckers, Albert; Ferone, Diego; van der Lely, Aart; Bollerslev, Jens; Boscaro, Marco; Brue, Thierry; Bruzzi, Paolo; Casanueva, Felipe F; Chanson, Philippe; Colao, Annamaria; Reincke, Martin; Stalla, Günter; Tsagarakis, Stelios

2015-06-01

A number of factors can influence the reported outcomes of transsphenoidal surgery (TSS) for Cushing's disease - including different remission and recurrence criteria, for which there is no consensus. Therefore, a comparative analysis of the best treatment options and patient management strategies is difficult. In this review, we investigated the clinical outcomes of initial TSS in patients with Cushing's disease based on definitions of and assessments for remission and recurrence. We systematically searched PubMed and identified 44 studies with clear definitions of remission and recurrence. When data were available, additional analyses by time of remission, tumor size, duration of follow-up, surgical experience, year of study publication and adverse events related to surgery were performed. Data from a total of 6400 patients who received microscopic TSS were extracted and analyzed. A variety of definitions of remission and recurrence of Cushing's disease after initial microscopic TSS was used, giving broad ranges of remission (42.0-96.6%; median, 77.9%) and recurrence (0-47.4%; median, 11.5%). Better remission and recurrence outcomes were achieved for microadenomas vs macroadenomas; however, no correlations were found with other parameters, other than improved safety with longer surgical experience. The variety of methodologies used in clinical evaluation of TSS for Cushing's disease strongly support the call for standardization and optimization of studies to inform clinical practice and maximize patient outcomes. Clinically significant rates of failure of initial TSS highlight the need for effective second-line treatments. © 2015 European Society of Endocrinology.

Evaluation of a Shared Decision-Making Intervention on the Utilization of Evidence-Based Psychotherapy in a VA Outpatient PTSD Clinic.

PubMed

Hessinger, Jonathan D; London, Melissa J; Baer, Sheila M

2017-03-13

The Veterans Health Administration (VHA) has continued to emphasize the availability, access, and utilization of high quality mental health care particularly in the treatment of posttraumatic stress disorder (PTSD). While dissemination and availability of evidence-based psychotherapies (EBPs) have only increased, treatment engagement and utilization have continued to be oft-noted challenges. Administrators, researchers, and individual clinicians have continued to develop and explore novel systemic and individualized interventions to address these issues. Pilot studies utilizing shared decision-making models to aid in veteran treatment selection have demonstrated the impact this approach may have on selection of and engagement in EBPs for PTSD. Based on these promising studies, a Department of Veterans Affairs (VA) outpatient PTSD clinic began to implement a shared-decision making intervention as part of a clinic redesign. In seeking to evaluate the impact of this intervention, archival clinical data from 1,056 veterans were reviewed by the authors for rates of treatment selection, EBP initiation, session attendance, and EBP completion. Time elapsed from consult until EBP initiation was also computed by the authors. These variables were then compared on the basis of whether the veteran received the shared-decision making intervention. Veterans who received the intervention were more likely to select and thus initiate an EBP for PTSD sooner than veterans who did not receive this intervention. Veterans, whether receiving the intervention or not, did not differ in therapy session attendance and completion. Implications of these findings and directions for future study are further discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

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

DTIC Science & Technology

2016-10-01

Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...impacting both the initial choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that...predict reclassification from Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study

Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China.

PubMed

Li, Shenshen; Wu, Yangfeng; Du, Xin; Li, Xian; Patel, Anushka; Peterson, Eric D; Turnbull, Fiona; Lo, Serigne; Billot, Laurent; Laba, Tracey; Gao, Runlin

2015-03-01

Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial. The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke. The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS. Copyright © 2014 Elsevier Inc. All rights reserved.

The effect of systemic antibiotics administered during the active phase of non-surgical periodontal therapy or after the healing phase: a systematic review.

PubMed

Fritoli, Aretuza; Gonçalves, Cristiane; Faveri, Marcelo; Figueiredo, Luciene Cristina; Pérez-Chaparro, Paula Juliana; Fermiano, Daiane; Feres, Magda

2015-01-01

The aim of this systematic review was to compare the clinical effectiveness of systemic antibiotics administered in the active stage of periodontal treatment or after the healing phase. An electronic search was performed in the databases EMBASE, MEDLINE and Cochrane Central Register of Controlled Trials (CENTRAL), in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement. A manual search of the reference list of selected studies and of review articles was also performed up to November 2013. Randomized Clinical Trials (RCT) that evaluated the systemic administration of antibiotics as adjuvants to scaling and root planning (SRP) at different phases of periodontal treatment were included. Systematic reviews and studies that evaluated subjects with systemic diseases and those that used subantimicrobial doses of antibiotics were excluded. The initial search identified 1,039 articles, of which seven were selected, and only one met the inclusion criteria. This study showed that subjects taking metronidazole and amoxicillin at the initial phase of treatment exhibited statistically significantly greater reduction in pocket depth and gain in clinical attachment level in initially deep sites (PD≥7 mm) than subjects taking antibiotics after healing (p<0.05). This comparison was conducted 2 months after antibiotic intake, at the healing phase. To date, only one short-term RCT has directly compared different moments of systemic antibiotics administration, as adjuncts to SRP, in the treatment of periodontitis. Although the results of this study suggested some benefits for antibiotics intake during the active phase of therapy, these findings need to be confirmed by larger placebo-controlled randomized clinical trials with longer follow-up periods.

Use of demographic and pharmacy data to identify patients included within both the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN).

PubMed

Carbonari, Dena M; Saine, M Elle; Newcomb, Craig W; Blak, Betina; Roy, Jason A; Haynes, Kevin; Wood, Jennifer; Gallagher, Arlene M; Bhullar, Harshvinder; Cardillo, Serena; Hennessy, Sean; Strom, Brian L; Lo Re, Vincent

2015-09-01

Pharmacoepidemiology researchers often utilize data from two UK electronic medical record databases, the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN), and may choose to combine the two in an effort to increase sample size. To minimize duplication of data, previous studies examined the practice-level overlap between these databases. However, the proportion of overlapping patients remains unknown. We developed a method using demographic and pharmacy variables to identify patients included in both CPRD and THIN, and applied this method to measure the proportion of overlapping patients who initiated the oral anti-diabetic drug saxagliptin. We conducted a cross-sectional study among patients initiating saxagliptin in CPRD and THIN between October 2009 and September 2012. Within both databases, we identified patients: (i) ≥18 years, (ii) newly prescribed saxagliptin, and (iii) with ≥180 days enrollment prior to saxagliptin initiation. Demographic data (birth year, sex, patient registration date, family number, and marital status) and prescriptions (including dates) for the first two oral anti-diabetic drugs prescribed within the study period were used to identify matching patients. Among 4202 CPRD and 3641 THIN patients initiating saxagliptin, 2574 overlapping patients (61% of CPRD saxagliptin initiators; 71% of THIN saxagliptin initiators) were identified. Among these patients, 2474 patients (96%) perfectly matched on all demographic and prescription data. Within each database, over 60% of patients initiating saxagliptin were included within both CPRD and THIN. Combined demographic and prescription data can be used to identify patients included in both CPRD and THIN. Copyright © 2015 John Wiley & Sons, Ltd.

Computerized Decision Support System Improves Fluid Resuscitation Outcomes Following Severe Burns: An Original Study

DTIC Science & Technology

2011-01-01

clinical decision- making paradigms, coupled with regula- tory and technical limitations, is just one of the hurdles that has kept advanced information...responses to assist care personnel during the resuscitation phase. CDSSs have been successfully used in the clinical setting for several years (23–24...because of clinical complications, death, or other factors were excluded. The control cohort included only patients who sur- vived for the initial 24

First-in-human Phase 1 CRISPR Gene Editing Cancer Trials: Are We Ready?

PubMed

Baylis, Francoise; McLeod, Marcus

2017-01-01

A prospective first-in-human Phase 1 CRISPR gene editing trial in the United States for patients with melanoma, synovial sarcoma, and multiple myeloma offers hope that gene editing tools may usefully treat human disease. An overarching ethical challenge with first-in-human Phase 1 clinical trials, however, is knowing when it is ethically acceptable to initiate such trials on the basis of safety and efficacy data obtained from pre-clinical studies. If the pre-clinical studies that inform trial design are themselves poorly designed - as a result of which the quality of pre-clinical evidence is deficient - then the ethical requirement of scientific validity for clinical research may not be satisfied. In turn, this could mean that the Phase 1 clinical trial will be unsafe and that trial participants will be exposed to risk for no potential benefit. To assist sponsors, researchers, clinical investigators and reviewers in deciding when it is ethically acceptable to initiate first-in-human Phase 1 CRISPR gene editing clinical trials, structured processes have been developed to assess and minimize translational distance between pre-clinical and clinical research. These processes draw attention to various features of internal validity, construct validity, and external validity. As well, the credibility of supporting evidence is to be critically assessed with particular attention to optimism bias, financial conflicts of interest and publication bias. We critically examine the pre-clinical evidence used to justify the first-inhuman Phase 1 CRISPR gene editing cancer trial in the United States using these tools. We conclude that the proposed trial cannot satisfy the ethical requirement of scientific validity because the supporting pre-clinical evidence used to inform trial design is deficient. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Nurses' and midwives' clinical leadership development needs: a mixed methods study.

PubMed

Casey, Mary; McNamara, Martin; Fealy, Gerard; Geraghty, Ruth

2011-07-01

This paper is a report of a descriptive study of nurses' and midwives' clinical leadership development needs. Nurses and midwives are expected to fulfil a leadership role at all levels, yet efforts to strategically support them are often unfocused. An analysis of clinical leadership development needs can provide the foundation for leadership initiatives to support staff. A mixed methods design was used. A questionnaire was sent to 911 nurses and midwives and 22 focus groups comprising 184 participants were conducted. Data were collected between March and June 2009 across all promotional grades of nurses and midwives in Ireland. Repeated measures anova with Greenhouse-Geisser adjustment was used for post hoc pair wise comparisons of the subscale dimensions of clinical leadership. anova with Tukey's post hoc method was used for comparison between grades on each individual subscale. Thematic analysis was undertaken on the focus group data. Results reveal that needs related to development of the profession were the highest for all grades. The staff grade expressed a higher need in relation to 'managing clinical area', 'managing the patient care' and 'skills for clinical leadership' than managers. Qualitative analysis yielded five themes; (1) clinical leadership and leaders from a nursing and midwifery perspective; (2) quality service from a nursing and midwifery perspective; (3) clinical leaders' roles and functions; (4) capital and (5) competences for clinical leaders and leadership and the context of clinical leadership. Clinical leadership concerns quality, safety and effectiveness. Nurses and midwives are ideally placed to offer the clinical leadership that is required to ensure these patient care outcomes. Development initiatives must address the leader and leadership competencies to support staff. © 2011 Blackwell Publishing Ltd.

Fracture Surface Analysis of Clinically Failed Fixed Partial Dentures

PubMed Central

Taskonak, B.; Mecholsky, J.J.; Anusavice, K.J.

2008-01-01

Ceramic systems have limited long-term fracture resistance, especially when they are used in posterior areas or for fixed partial dentures. The objective of this study was to determine the site of crack initiation and the causes of fracture of clinically failed ceramic fixed partial dentures. Six Empress 2® lithia-disilicate (Li2O·2SiO2)-based veneered bridges and 7 experimental lithia-disilicate-based non-veneered ceramic bridges were retrieved and analyzed. Fractography and fracture mechanics methods were used to estimate the stresses at failure in 6 bridges (50%) whose fracture initiated from the occlusal surface of the connectors. Fracture of 1 non-veneered bridge (8%) initiated within the gingival surface of the connector. Three veneered bridges fractured within the veneer layers. Failure stresses of the all-core fixed partial dentures ranged from 107 to 161 MPa. Failure stresses of the veneered fixed partial dentures ranged from 19 to 68 MPa. We conclude that fracture initiation sites are controlled primarily by contact damage. PMID:16498078

Cognitive function in early HIV infection.

PubMed

Prakash, Aanchal; Hou, Jue; Liu, Lei; Gao, Yi; Kettering, Casey; Ragin, Ann B

2017-04-01

This study aimed to examine cognitive function in acute/early HIV infection over the subsequent 2 years. Fifty-six HIV+ subjects and 21 seronegative participants of the Chicago Early HIV Infection Study were evaluated using a comprehensive neuropsychological assessment at study enrollment and at 2-year follow-up. Cognitive performance measures were compared in the groups using t tests and mixed-effect models. Patterns of relationship with clinical measures were determined between cognitive function and clinical status markers using Spearman's correlations. At the initial timepoint, the HIV group demonstrated significantly weaker performance on measures of verbal memory, visual memory, psychomotor speed, motor speed, and executive function. A similar pattern was found when cognitive function was examined at follow-up and across both timepoints. The HIV subjects had generally weaker performance on psychomotor speed, executive function, motor speed, visual memory, and verbal memory. The rate of decline in cognitive function across the 2-year follow-up period did not differ between groups. Correlations between clinical status markers and cognitive function at both timepoints showed weaker performance associated with increased disease burden. Neurocognitive difficulty in chronic HIV infection may have very early onset and reflect consequences of initial brain viral invasion and neuroinflammation during the intense, uncontrolled viremia of acute HIV infection. Further characterization of the changes occurring in initial stages of infection and the risk and protective factors for cognitive function could inform new strategies for neuroprotection.

Interim Methadone and Patient Navigation in Jail: Rationale and Design of a Randomized Clinical Trial

PubMed Central

Schwartz, Robert P.; Kelly, Sharon M.; Mitchell, Shannon G.; Dunlap, Laura; Zarkin, Gary A.; Sharma, Anjalee; O’Grady, Kevin E.; Jaffe, Jerome H.

2016-01-01

Background Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. Methods This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30 days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. Results We describe the background and rationale for the study, its aims, hypotheses, and study design. Conclusions Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. PMID:27282117

Indication for Dialysis Initiation and Mortality in Patients With Chronic Kidney Failure: A Retrospective Cohort Study

PubMed Central

Rivara, Matthew B.; Chen, Chang Huei; Nair, Anupama; Cobb, Denise; Himmelfarb, Jonathan; Mehrotra, Rajnish

2016-01-01

Background Initiation of maintenance dialysis for patients with chronic kidney failure is a period of high risk for adverse patient outcomes. Whether indications for dialysis initiation are associated with mortality among this population is unknown. Study Design Retrospective cohort study. Setting & Participants 461 patients who initiated dialysis (hemodialysis, 437; peritoneal dialysis, 24) from January 1st, 2004 through December 31st, 2012 and were treated in facilities operated by a single dialysis organization. Follow-up for the primary outcome was through December 31st, 2013. Predictor Clinically documented primary indication for dialysis initiation, as categorized into four groups: laboratory evidence of kidney function decline (reference category), uremic symptoms, volume overload or hypertension, and other/unknown. Outcomes All-cause mortality Results Over a median follow-up of 2.4 years, 183 (40%) patients died. Crude mortality rates were 10.0 (95% CI, 6.8–14.7), 12.7 (95% CI, 10.2–15.7), 21.7 (95% CI, 16.4–28.6), and 12.2 (95% CI, 6.8–14.7) per 100 patient-years among patients initiating dialysis primarily for laboratory evidence of kidney function decline, uremic symptoms, volume overload or hypertension, and other/unknown reason, respectively. Following adjustment for demographic variables, coexisting illnesses, and estimated glomerular filtration rate, initiation of dialysis for uremic symptoms, volume overload or hypertension, or for other/unknown reasons were associated with 1.12 (95% CI, 0.72–1.77), 1.71 (95% CI, 1.03–2.84), and 1.28 (95% CI, 0.73–2.26) times higher risk, respectively, for subsequent mortality compared to initiation for laboratory evidence of kidney function decline. Limitations Possibility of residual confounding by unmeasured variables; reliance on clinical documentation to ascertain exposure Conclusions Patients initiating dialysis due to volume overload may have increased risk for mortality compared to patients initiating dialysis due to laboratory evidence of kidney function decline. Further studies are needed to identify and test interventions that might reduce this risk. PMID:27637132

Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

PubMed

Ito, Tatsuya

2016-01-01

Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs). In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs. The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries. Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data. New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants. There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.

Retrospective comparison of abdominal ultrasonography and radiography in the investigation of feline abdominal disease

PubMed Central

Won, Wylen Wade; Sharma, Ajay; Wu, Wenbo

2015-01-01

Abdominal radiography and ultrasonography are commonly used as part of the initial diagnostic plan for cats with nonspecific signs of abdominal disease. This retrospective study compared the clinical usefulness of abdominal radiography and ultrasonography in 105 feline patients with signs of abdominal disease. The final diagnosis was determined more commonly with ultrasonography (59%) compared to radiography (25.7%). Ultrasonography was also able to provide additional clinically relevant information in 76% of cases, and changed or refined the diagnosis in 47% of cases. Based on these findings, ultrasonography may be sufficient as an initial diagnostic test for the investigation of feline abdominal disease. PMID:26483582

Postconditioning hormesis put in perspective: an overview of experimental and clinical studies.

PubMed

Wiegant, F A C; Prins, H A B; Van Wijk, R

2011-01-01

A beneficial effect of applying mild stress to cells or organisms, that were initially exposed to a high dose of stress, has been referred to as 'postconditioning hormesis'. The initial high dose of stress activates intrinsic self-recovery mechanisms. Modulation of these endogenous adaptation strategies by administration of a subsequent low dose of stress can confer effects that are beneficial to the biological system. Owing to its potentially therapeutic applications, postconditioning hormesis is subject to research in various scientific disciplines. This paper presents an overview of the dynamics of postconditioning hormesis and illustrates this phenomenon with a number of examples in experimental and clinical research.

Relationship between quality improvement processes and clinical performance.

PubMed

Damberg, Cheryl L; Shortell, Stephen M; Raube, Kristiana; Gillies, Robin R; Rittenhouse, Diane; McCurdy, Rodney K; Casalino, Lawrence P; Adams, John

2010-08-01

To examine the association between performance on clinical process measures and intermediate outcomes and the use of chronic care management processes (CMPs), electronic medical record (EMR) capabilities, and participation in external quality improvement (QI) initiatives. Cross-sectional analysis of linked 2006 clinical performance scores from the Integrated Healthcare Association's pay-for-performance program and survey data from the 2nd National Study of Physician Organizations among 108 California physician organizations (POs). Controlling for differences in PO size, organization type (medical group or independent practice association), and Medicaid revenue, we used ordinary least squares regression analysis to examine the association between the use of CMPs, EMR capabilities, and external QI initiatives and performance on the following 3 clinical composite measures: diabetes management, processes of care, and intermediate outcomes (diabetes and cardiovascular). Greater use of CMPs was significantly associated with clinical performance: among POs using more than 5 CMPs, we observed a 3.2-point higher diabetes management score on a performance scale with scores ranging from 0 to 100 (P <.001), while for each 1.0-point increase on the CMP index, we observed a 1.0-point gain in intermediate outcomes (P <.001). Participation in external QI initiatives was positively associated with improved delivery of clinical processes of care: a 1.0-point increase on the QI index translated into a 1.4-point gain in processes-of-care performance (P = .02). No relationship was observed between EMR capabilities and performance. Greater investments in CMPs and QI interventions may help POs raise clinical performance and achieve success under performance-based accountability schemes.

Statement on Public-Private Partnerships as Part of the NIH HEAL Initiative

MedlinePlus

... Record Research & Training Medical Research Initiatives Science Highlights Science Education Research in NIH Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation ...

Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial.

PubMed

Sudfeld, Christopher R; Mugusi, Ferdinand; Aboud, Said; Nagu, Tumaini J; Wang, Molin; Fawzi, Wafaie W

2017-02-10

HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in high-income and resource-limited settings indicate that HIV-infected adults with low vitamin D levels may be at increased risk of mortality, HIV disease progression, and incidence of pulmonary tuberculosis (TB). As a result, vitamin D 3 supplementation may improve survival and treatment outcomes for HIV-infected adults initiating ART. The Trial of Vitamins-4 (ToV4) is an individually randomized, double-blind, placebo-controlled trial of vitamin D 3 (cholecalciferol) supplementation conducted among 4000 HIV-infected adults with low vitamin D levels [25-hydroxyvitamin D (25(OH)D) <30 ng/mL] initiating ART in Dar es Salaam, Tanzania. The two primary aims of the trial are to determine the effect of a vitamin D 3 supplementation regimen on incidence of (1) mortality and (2) pulmonary TB as compared to a matching placebo regimen. The primary safety outcome of the study is incident hypercalcemia. The investigational vitamin D 3 regimen consists of oral supplements containing 50,000 IU vitamin D 3 taken under direct observation at randomization and once a week for 3 weeks (four doses) followed by daily oral supplements containing 2000 IU vitamin D 3 taken at home from the fourth week until trial discharge at 1 year post ART initiation. Trial participants are followed up at weekly clinic visits during the first month of ART and at monthly clinic visits thereafter until trial discharge at 1 year post ART initiation. Secondary aims of the trial are to examine the effect of the vitamin D 3 regimen on CD4 T cell reconstitution, incidence of non-TB comorbidities, body mass index (BMI), depression and anxiety, physical activity, bone health, and immunologic biomarkers. The ToV4 will provide causal evidence on the effect of vitamin D 3 supplementation on incidence of pulmonary TB and mortality among HIV-infected Tanzanian adults initiating ART. The trial will also give insight to whether vitamin D 3 supplementation trials for the prevention of pulmonary TB should be pursued in HIV-uninfected populations. ClinicalTrials.gov, NCT01798680 . Registered on 21 February 2013.

Initiation of parturition in humans.

PubMed

Drover, J W; Casper, R F

1983-02-15

The mechanism by which parturition is initiated in humans is largely unknown. The placenta and fetal membranes appear to play the major role in the initiation of labour, and the fetus may influence the timing of labour. Clinical observations and experiments with animals have revealed that placental neuropeptides may be able to control steroid metabolism and trigger the onset of labour, while the fetus may be able to interact with such events to initiate parturition at an appropriate time. However, further study is needed to determine the role of placental releasing factors and glycoprotein hormones and their ability to control placental steroid metabolism.

Dose Trends of Aripiprazole from 2004 to 2014 in Psychiatric Inpatients in Korea.

PubMed

Woo, Young Sup; Shim, In Hee; Lee, Sang-Yeol; Lee, Dae-Bo; Kim, Moon-Doo; Jung, Young-Eun; Lee, Jonghun; Won, Seunghee; Jon, Duk-In; Bahk, Won-Myong

2017-05-31

Although aripiprazole has been widely used to treat various psychiatric disorders, little is known about the adequate dosage for Asian patients in clinical practice. Hence, we evaluated the initial and maximum doses of aripiprazole from 2004 to 2014 to estimate the appropriate dosage for Korean psychiatric inpatients in clinical practice. In this retrospective study, we reviewed the medical records of patients who were hospitalized in five university hospitals in Korea from March 2004 to December 2014. The psychiatric diagnosis according to the text revision of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition during index hospitalization and the initial and maximum doses of aripiprazole were evaluated. There were 74 patients in Wave 1 (2004-2006), 201 patients in Wave 2 (2007-2010), and 353 patients in Wave 3 (2011-2014). The initial doses of aripiprazole in all diagnostic groups were significantly lower in Wave 3 than in Wave 2. The maximum doses of aripiprazole in each diagnostic group were not significantly different among Waves 1, 2, and 3. The relatively low initial doses of aripiprazole documented in our study may reflect a strategy by clinicians to minimize the side effects associated with aripiprazole use, such as akathisia.

Effectiveness of Omalizumab in Severe Allergic Asthma: A Retrospective UK Real-World Study

PubMed Central

2013-01-01

Objective. The aim of this study was to evaluate the “real world” effects of the monoclonal antibody omalizumab (OMB) when used to treat severe persistent allergic asthma in UK clinical practice. Methods. A 10-center retrospective observational study was carried out to compare oral corticosteroid (OCS) use and exacerbation frequency in 12 months pre- versus post-OMB initiation in 136 patients aged ≥12 years with severe persistent allergic asthma. All patients received ≥1 dose of OMB. Patients who had received OMB in a clinical trial were excluded. Data were obtained from hospital and if necessary general practitioners’ (GPs’) records on OCS use, lung function, hospital resource use, and routinely used quality of life (QoL) measures at baseline (pre-OMB), 16 weeks, and up to 12 months post-OMB initiation. Results. Mean total quantity of OCS prescribed per year decreased by 34% between the 12 months pre- and post-OMB initiation. During the 12 months post-OMB initiation, 87 patients (64%) stopped/reduced OCS use by 20% or more and 66 (49%) stopped OCS completely. Mean percent predicted forced expiratory volume in one second (FEV1) increased from 66.0% at baseline to 75.2% at week 16 of OMB therapy. The number of asthma exacerbations decreased by 53% during the 12 months post-initiation. Accident and emergency visits reduced by 70% and hospitalizations by 61% in the 12 months post-OMB initiation. Conclusion. This retrospective analysis showed a reduction in exacerbations and improved QoL as per previous studies with OMB. However, the total reduction in annual steroid burden and improved lung function in this severely ill group of patients taking regular or frequent OCS is greater than that seen in previous trials. PMID:23574000

Early appendectomy reduces costs in children with perforated appendicitis.

PubMed

Church, Joseph T; Klein, Edwin J; Carr, Benjamin D; Bruch, Steven W

2017-12-01

Perforated appendicitis can be managed with early appendectomy, or nonoperative management followed by interval appendectomy. We aimed to identify the strategy with the lowest health care utilization and cost. We retrospectively reviewed the medical records of all children ≤18 years old with perforated appendicitis admitted to a single institution between January 2009 and March 2016. After excluding immunosuppressed patients and transfers from outside hospitals, we grouped the remaining patients by early or interval appendectomy. Cost accounting data were obtained from our institutional database. The primary outcome was total hospital cost over 2 y from initial admission for appendicitis. Other outcomes analyzed included initial admission costs, number of admissions, emergency room and clinic visits, percutaneous procedures, cross-sectional and overall imaging studies, and length of stay. A total of 203 children with perforated appendicitis were identified. After exclusion of immunosuppressed patients and outside hospital transfers, 94 patients were included in the study. Thirty-nine underwent early appendectomy and 55 initial nonoperative management; of these, 54 underwent elective interval appendectomy. Five of 55 patients (9%) failed initial nonoperative management and required earlier-than-planned appendectomy. Total cost over 2 y was significantly lower with early appendectomy than initial nonoperative management ($19,300 ± 14,300 versus $26,000 ± 17,500; P = 0.05). Early appendectomy resulted in fewer hospital admissions, clinic visits, invasive procedures, and imaging studies. Early appendectomy results in lower hospital costs and less health care utilization compared with initial nonoperative management with elective interval appendectomy. A prospective study will shed more light on this question and can assess the role of nonoperative management without interval appendectomy in children with perforated appendicitis. Copyright © 2017 Elsevier Inc. All rights reserved.

Practice development 'without walls' and the quandary of corporate practice.

PubMed

Graham, Iain; Fielding, Carol; Rooke, Debbie; Keen, Steven

2006-08-01

The context of this study is a group of clinical nurse specialists from across a Trust seeking accreditation as a practice development unit. The university was asked to facilitate the accreditation process via 11 2-hour learning sessions (including a one-hour focus group). During initial discussions between the university and practice development unit, the overarching research question for this study was set as: 'what are the main roles and responsibilities of clinical nurse specialists?' Although there is no known study of a practice development unit based beyond a ward or speciality, the central tenet of the practice development unit literature is that units must demonstrate their worth if they are to survive and harness senior management support in doing so. Data gleaned from the transcribed audio tape-recordings of the learning sessions were studied at least three times to ensure transcription accuracy and produce detailed charts. Ethical approval was granted by the appropriate Local Research Ethics Committee and written informed consent obtained from clinical nurse specialists. The study lasted 30 months and ended in October 2004. The four crucial statements that give meaning to specialist practice are: quality care giver; expert; information giver and initiator of change. Further analysis reveals the area of corporate and political practice as being missing from this and other lists of clinical nurse specialist attributes found in the literature. Clinical nurse specialists characterize their relationship with the Trust in terms of dichotomy--differing agendas and perceptions of value. The specialist role requires professional development in the areas of corporate and political acumen and professional business management. While the findings of this study relate to one Trust and a group of 16 clinical nurse specialists, with careful application they may be transferable to other settings and groups of senior nurses.

Proposed clinical case definition for cytomegalovirus-immune recovery retinitis.

PubMed

Ruiz-Cruz, Matilde; Alvarado-de la Barrera, Claudia; Ablanedo-Terrazas, Yuria; Reyes-Terán, Gustavo

2014-07-15

Cytomegalovirus (CMV) retinitis has been extensively described in patients with advanced or late human immunodeficiency virus (HIV) disease under ineffective treatment of opportunistic infection and antiretroviral therapy (ART) failure. However, there is limited information about patients who develop active cytomegalovirus retinitis as an immune reconstitution inflammatory syndrome (IRIS) after successful initiation of ART. Therefore, a case definition of cytomegalovirus-immune recovery retinitis (CMV-IRR) is proposed here. We reviewed medical records of 116 HIV-infected patients with CMV retinitis attending our institution during January 2003-June 2012. We retrospectively studied HIV-infected patients who had CMV retinitis on ART initiation or during the subsequent 6 months. Clinical and immunological characteristics of patients with active CMV retinitis were described. Of the 75 patients under successful ART included in the study, 20 had improvement of CMV retinitis. The remaining 55 patients experienced CMV-IRR; 35 of those developed CMV-IRR after ART initiation (unmasking CMV-IRR) and 20 experienced paradoxical clinical worsening of retinitis (paradoxical CMV-IRR). Nineteen patients with CMV-IRR had a CD4 count of ≥50 cells/µL. Six patients with CMV-IRR subsequently developed immune recovery uveitis. There is no case definition for CMV-IRR, although this condition is likely to occur after successful initiation of ART, even in patients with high CD4 T-cell counts. By consequence, we propose the case definitions for paradoxical and unmasking CMV-IRR. We recommend close follow-up of HIV-infected patients following ART initiation. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Diagnosis of airway obstruction in primary care in the UK: the CADRE (COPD and Asthma Diagnostic/management REassessment) programme 1997-2001.

PubMed

Pearson, Mike; Ayres, Jon G; Sarno, Maria; Massey, Dan; Price, David

2006-01-01

Asthma and COPD require different management strategies, but differentiation in primary care is difficult. This primary care support initiative observed the impact of spirometry and clinical assessment on the diagnosis of airway disease. Of 61,191 patients aged > or =40 years being treated for respiratory conditions within 1003 UK primary care practices, 43,203 underwent a diagnostic review including standardized spirometric assessment. The proportion of patients in whom the diagnosis was changed by the additional information was determined. The relationship of various patient characteristics was compared with the baseline and review diagnoses and with any change in diagnosis. Asthma was initially diagnosed in 43% of patients, COPD in 35%, mixed disease in 9%, and other respiratory condition in 13%. Patients initially diagnosed with asthma, mixed disease, or another condition were more likely to have their diagnosis changed at review (54%, 46%, and 63%, respectively) than those initially diagnosed with COPD (14%). A change from asthma to COPD was associated with male gender, smoking, older age, and reduced lung function, the opposite being associated with a change from COPD to asthma. In this study, a clinical review supplemented by additional information including spirometry highlights apparent mislabeling of significant numbers of patients with chronic obstructive disease in general practice with significant implications for individual treatment and healthcare provision. This study shows that the addition of more clinical information can have a major effect on diagnostic tendency in patients with airway disease. An initial diagnosis of COPD seems less likely to change following review than an asthma diagnosis. While it is likely that greater information leads to a more accurate diagnosis, the differential effect of new information on diagnostic labeling highlights the insecurity of the diagnostic process in primary care in the UK.

Does Cognitive Behavioral Therapy for Youth Anxiety Outperform Usual Care in Community Clinics? An Initial Effectiveness Test

ERIC Educational Resources Information Center

Southam-Gerow, Michael A.; Weisz, John R.; Chu, Brian C.; McLeod, Bryce D.; Gordis, Elana B.; Connor-Smith, Jennifer K.

2010-01-01

Objective: Most tests of cognitive behavioral therapy (CBT) for youth anxiety disorders have shown beneficial effects, but these have been efficacy trials with recruited youths treated by researcher-employed therapists. One previous (nonrandomized) trial in community clinics found that CBT did not outperform usual care (UC). The present study used…

Haloperidol Treatment with Chronically Medicated Residents: Dose Effects on Clinical Behavior and Reinforcement Contingencies.

ERIC Educational Resources Information Center

Aman, Michael G.; And Others

1989-01-01

The study of effects of haloperidol drug therapy with 20 institutionalized mentally retarded persons found clinical changes confined to a slight reduction in stereotypic behavior and an increase in gross motor activity under the high dose condition. Subjects with high initial levels of stereotypy showed the best response to the drug. (Author/DB)

Autopsy-confirmed hippocampal-sparing Alzheimer's disease with delusional jealousy as initial manifestation.

PubMed

Fujishiro, Hiroshige; Iritani, Shuji; Hattori, Miho; Sekiguchi, Hirotaka; Matsunaga, Shinji; Habuchi, Chikako; Torii, Youta; Umeda, Kentaro; Ozaki, Norio; Yoshida, Mari; Fujita, Kiyoshi

2015-09-01

Alzheimer's disease (AD) is clinically characterized by gradual onset over years with worsening of cognition. The initial and most prominent cognitive deficit is commonly memory dysfunction. However, a subset of AD cases has less hippocampal atrophy than would be expected relative to the predominance of cortical atrophy. These hippocampal-sparing cases have distinctive clinical features, including the presence of focal cortical clinical syndromes. Given that previous studies have indicated that severe hippocampal atrophy corresponds to prominent loss of episodic memory, it is likely that memory impairment is initially absent in hippocampal-sparing AD cases. Here, we report on a patient with an 8-year history of delusional jealousy with insidious onset who was clinically diagnosed as possible AD and pathologically confirmed to have AD with relatively preserved neurons in the hippocampus. This patient had delusional jealousy with a long pre-dementia stage, which initially was characterized by lack of memory impairment. Head magnetic resonance imaging findings showed preserved hippocampal volume with bilateral enlarged ventricles and mild-to-moderate cortical atrophy. Head single-photon emission computed tomography revealed severely decreased regional cerebral blood flow in the right temporal lobe. The resolution of the delusion was attributed to pharmacotherapy by an acetylcholinesterase inhibitor, suggesting that the occurrence of delusional jealousy was due to the disease process of AD. Although the neural basis of delusional jealousy remains unclear, this hippocampal-sparing AD case may be classified as an atypical presentation of AD. © 2015 The Authors. Psychogeriatrics © 2015 Japanese Psychogeriatric Society.

Papillon-Lefèvre syndrome: a successful outcome.

PubMed

Ahuja, Vanita; Shin, Richard Hochul; Mudgil, Adarsh; Nanda, Veena; Schoor, Robert

2005-11-01

Papillon-Lefèvre syndrome (PLS) is a rare autosomal recessive condition manifested clinically by hyperkeratosis of the palms and soles and rapidly progressive periodontitis resulting in loss of deciduous and permanent teeth. This case report describes the clinical periodontal findings and treatment of a 10-year-old male patient with PLS. The patient provided informed consent, and the study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000. Upon initial presentation, a full periodontal examination was completed. Conventional probing depths, clinical attachment levels (CAL), gingival index (GI), and plaque index (PI) were measured prior to initial therapy, which involved oral hygiene instruction and scaling and root planing. At reevaluation, initial treatment proved unsuccessful, and a surgical approach with concomitant systemic antibiotic therapy was implemented. In addition, the patient's dermatologist treated his palmoplantar keratoderma with systemic retinoids. Subsequently, the patient was placed on a strict 3-month maintenance protocol and was evaluated over a period of 1 year. Initial treatment with mechanical therapy, oral hygiene instruction, frequent recalls, and systemic antibiotics did not yield efficacious results. However, with the addition of surgical treatment, a favorable clinical outcome was obtained. Numerous treatment regimens for the periodontal disease seen in PLS can be found in the literature. We demonstrate successful treatment of the periodontal disease seen in this condition using mechanical therapy, systemic antibiotics, and surgical modalities; over a period of 1 year, we were able to achieve significant reductions in gingival inflammation and erythema.

Complementary and alternative medicine use in patients presenting to a head and neck oncology clinic.

PubMed

Vyas, Tarren; Hart, Robert D; Trites, Jonathan R; Philips, Timothy J; Archibald, Kathleen E M; Phillips, Judith E; Taylor, S Mark

2010-06-01

The aim of this study was to determine the prevalence of complementary and alternative medicine (CAM) use among patients presenting to a head and neck oncology clinic prior to a diagnosis. The study was conducted by administering questionnaires to 102 patients after being seen in the Head and Neck Oncology clinic for their initial consultation. The questionnaire assessed the extent of CAM use, types of CAMs used, and their reasons for use. A total of 132 CAMs were currently being used among 56 patients. The most common CAMs in use were multivitamins (26/132) and vitamin D (21/132). Meditation and yoga were associated with the greatest perceived benefit. The majority of patients obtained their information from family and friends. Most patients were using CAMs for physical health and well-being. As CAM use among the population is widespread, it is important for clinicians to specifically address their use on initial presentation. (c) 2009 Wiley Periodicals, Inc. Head Neck, 2010.

Abdominal aortic aneurysm events in the women's health initiative: cohort study.

PubMed

Lederle, Frank A; Larson, Joseph C; Margolis, Karen L; Allison, Matthew A; Freiberg, Matthew S; Cochrane, Barbara B; Graettinger, William F; Curb, J David

2008-10-14

To assess the association between potential risk factors and subsequent clinically important abdominal aortic aneurysm events (repairs and ruptures) in women. Large prospective observational cohort study with mean follow-up of 7.8 years. 40 clinical centres across the United States. 161 808 postmenopausal women aged 50-79 enrolled in the women's health initiative. Association of self reported or measured baseline variables with confirmed abdominal aortic aneurysm events assessed with multiple logistic regression. Events occurred in 184 women and were strongly associated with age and smoking. Ever smoking, current smoking, and amount smoked all contributed independent risk. Diabetes showed a negative association (odds ratio 0.29, 95% confidence interval 0.13, 0.68), as did postmenopausal hormone therapy. Positive associations were also seen for height, hypertension, cholesterol lowering treatment, and coronary and peripheral artery disease. Our findings confirm the strong positive associations of clinically important abdominal aortic aneurysm with age and smoking in women and the negative association with diabetes previously reported in men.

Clinical characteristics of central diabetes insipidus in Taiwanese children.

PubMed

Liu, Shih-Yao; Tung, Yi-Ching; Lee, Cheng-Ting; Liu, Hon-Man; Peng, Shinn-Forng; Wu, Mu-Zon; Kuo, Meng-Fai; Tsai, Wen-Yu

2013-10-01

Data on the clinical features of children with central diabetes insipidus (CDI) are lacking in Taiwan. This study investigated the clinical manifestations and etiology of CDI in Taiwanese children. From 1983 to 2012, 62 children with permanent diabetes insipidus were enrolled in the study. They were diagnosed at the Department of Pediatrics of National Taiwan University Hospital. Their medical records were thoroughly reviewed and their clinical symptoms and signs, laboratory data, and etiologies were analyzed. The patients' median age at diagnosis was 10 years and the median interval between initial manifestations and diagnosis was 0.5 years. The most common symptoms and signs were polyuria, polydipsia, nocturia, and growth retardation. Most patients had low urine osmolality and elevated plasma osmolality on diagnosis. Absence of a posterior pituitary hyperintense signal and thickening of the pituitary stalk were common findings on magnetic resonance imaging. Approximately 80% of the patients had anterior pituitary hormone deficiency and all patients had growth hormone deficiency. Approximately 60% of patients had intracranial lesions, the most common causes of which were germ cell tumor and Langerhans cell histiocytosis. Two patients were initially believed to have idiopathic CDI but intracranial lesions were detected during the follow-up period. Because a delayed diagnosis of CDI is common in Taiwanese children, a high index of suspicion is important. The underlying etiology of CDI in children may not initially be obvious. Long-term surveillance is therefore necessary, especially for the early detection of evolving treatable intracranial lesions. Copyright © 2013. Published by Elsevier B.V.

Impact of centralized diagnostic review on quality of initial staging in Hodgkin lymphoma: experience of the German Hodgkin Study Group.

PubMed

Bröckelmann, Paul J; Goergen, Helen; Fuchs, Michael; Kriz, Jan; Semrau, Robert; Baues, Christian; Kobe, Carsten; Behringer, Karolin; Eichenauer, Dennis A; von Tresckow, Bastian; Klimm, Beate; Halbsguth, Teresa; Wongso, Diana; Plütschow, Annette; Haverkamp, Heinz; Dietlein, Markus; Eich, Hans T; Stein, Harald; Diehl, Volker; Borchmann, Peter; Engert, Andreas

2015-11-01

Accurate clinical staging is crucial for adequate risk-adapted treatment in Hodgkin lymphoma (HL) to prevent patients from under- or over-treatment. Within the latest German Hodgkin Study Group trial generation, diagnostic findings such as histopathology, computerized tomography imaging and clinical risk factors were re-evaluated by expert panels. Here, we retrospectively analysed 5965 patients and identified 399 in who major discordant findings changed their first-line treatment allocation. Histopathology review did not confirm the initial diagnosis of HL in 87 patients. Treatment allocation was revised in 312 of the remaining 5878 patients: 176 were assigned to a higher and 128 to a lower risk group, respectively; the correct treatment group remained unclear in 8 patients. Cases of revised treatment allocation accounted for 9·8%, 6·0%, 0·8%, and 14·8% of patients initially assigned to the HD13, HD14, HD15 trials and stage IA lymphocyte-predominant HL project, respectively. Most revisions were due to wrong application of clinical stage (20·5% of 312 patients with revised treatment group), histological subtype (9·0%) or the risk factors ≥3 involved areas (46·8%) or large mediastinal mass (9·3%). In conclusion, centralized review by experienced experts changed risk-adapted first-line treatment in a relevant proportion of HL patients. Quality control measures clearly improve the accuracy of treatment and should be implemented in clinical practice. © 2015 John Wiley & Sons Ltd.

Breast-feeding and Vitamin D Supplementation Rates in the Ochsner Health System

PubMed Central

Ponnapakkam, Tulasi; Ravichandran, Anisha; Bradford, Elease; Tobin, Gregory; Gensure, Robert

2008-01-01

Breast-feeding imparts many benefits to both mothers and infants. Because of these numerous recognized benefits, there has been an effort to increase breast-feeding rates nationwide; increasing breast-feeding rates was one of the goals of the U.S. Department of Health and Human Services' Healthy People 2010 initiative. This study examined the breast-feeding rate at the Ochsner Clinic Foundation by conducting a retrospective chart review of patients aged 0–12 months who visited any branch of the Ochsner hospital system. Our results indicate that the rate of initiation of breast-feeding for children followed at the Ochsner Clinic Foundation is 66.3%. However, as breast-feeding rates rise, there is concern that there may be a resurgence of rickets, a disease caused by the deficiency of vitamin D. Currently the American Academy of Pediatrics recommends that exclusively breast-fed infants receive vitamin D supplementation starting within the first 2 months of life. We have therefore initiated a clinical trial to determine whether vitamin D supplementation is required to prevent rickets in breast-fed children. In the course of conducting this study, we have gathered additional data regarding the patterns of breast-feeding and of vitamin D supplementation for babies born at Ochsner. PMID:21603467

Breast-feeding and Vitamin D Supplementation Rates in the Ochsner Health System.

PubMed

Ponnapakkam, Tulasi; Ravichandran, Anisha; Bradford, Elease; Tobin, Gregory; Gensure, Robert

2008-01-01

Breast-feeding imparts many benefits to both mothers and infants. Because of these numerous recognized benefits, there has been an effort to increase breast-feeding rates nationwide; increasing breast-feeding rates was one of the goals of the U.S. Department of Health and Human Services' Healthy People 2010 initiative. This study examined the breast-feeding rate at the Ochsner Clinic Foundation by conducting a retrospective chart review of patients aged 0-12 months who visited any branch of the Ochsner hospital system. Our results indicate that the rate of initiation of breast-feeding for children followed at the Ochsner Clinic Foundation is 66.3%. However, as breast-feeding rates rise, there is concern that there may be a resurgence of rickets, a disease caused by the deficiency of vitamin D. Currently the American Academy of Pediatrics recommends that exclusively breast-fed infants receive vitamin D supplementation starting within the first 2 months of life. We have therefore initiated a clinical trial to determine whether vitamin D supplementation is required to prevent rickets in breast-fed children. In the course of conducting this study, we have gathered additional data regarding the patterns of breast-feeding and of vitamin D supplementation for babies born at Ochsner.

Assessment of Confounders in Comparative Effectiveness Studies From Secondary Databases.

PubMed

Franklin, Jessica M; Schneeweiss, Sebastian; Solomon, Daniel H

2017-03-15

Secondary clinical databases are an important and growing source of data for comparative effectiveness research (CER) studies. However, measurement of confounders, such as biomarker values or patient-reported health status, in secondary clinical databases may not align with the initiation of a new treatment. In many published CER analyses of registry data, investigators assessed confounders based on the first questionnaire in which the new exposure was recorded. However, it is known that adjustment for confounders measured after the start of exposure can lead to biased treatment effect estimates. In the present study, we conducted simulations to compare assessment strategies for a dynamic clinical confounder in a registry-based comparative effectiveness study of 2 therapies. As expected, we found that adjustment for the confounder value at the time of the first questionnaire after the start of exposure creates a biased estimate the total effect of exposure choice on outcome when the confounder mediates part of the effect. However, adjustment for the prior value can also be badly biased when measured long before exposure initiation. Thus, investigators should carefully consider the timing of confounder measurements relative to exposure initiation and the rate of change in the confounder in order to choose the most relevant measure for each patient. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Efficacy of 1% Metformin Gel in Patients With Moderate and Severe Chronic Periodontitis: A Randomized Controlled Clinical Trial.

PubMed

Pradeep, A R; Patnaik, Kaushik; Nagpal, Kanika; Karvekar, Shruti; Guruprasad, C N; Kumaraswamy, K M

2017-10-01

The aim of this study is to investigate efficacy of metformin (MF) 1% gel as an adjunct to scaling and root planing (SRP) in the treatment of moderate and severe chronic periodontitis (CP). Seventy patients were categorized into two treatment groups: 1) SRP plus 1% MF and 2) SRP plus placebo. Clinical parameters were recorded at baseline and 3, 6, and 9 months. They included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). Radiologic assessment of intrabony defects (IBDs) and percentage defect depth reduction (DDR%) was done at baseline and 6- and 9-month intervals using computer-aided software. PD, CAL, and DDR% were evaluated in two subgroups in both the placebo and MF group: 1) initial PD of 5 to 7 mm and 2) initial PD of >7 mm. Mean PD reduction and mean CAL gain was found to be greater in the MF group than the placebo group at all visits. Clinical parameters (PD, CAL) in both subgroups, with initial PDs of 5 to 7 and >7 mm, showed significant improvement in the 1% MF group compared with the placebo group. A significantly greater mean DDR% was found in the MF group than the placebo group at 6 and 9 months in both subgroups, 5 to 7 and >7 mm of initial PD. There was a greater decrease in PD and more CAL gain with significant IBD depth reduction at sites treated with SRP plus locally delivered MF in patients with CP in both initial PD = 5 to 7 and >7 mm subgroups compared with placebo.

Computed Tomography Angiography in Patients Evaluated for Acute Pulmonary Embolism with Low Serum D-dimer Levels: A Prospective Study

PubMed Central

Gimber, Lana Hirai; Travis, R Ing; Takahashi, Jayme M; Goodman, Torrey L; Yoon, Hyo-Chun

2009-01-01

Context: Pulmonary computed tomography angiography (CTA) and the Wells criteria both have interobserver variability in the assessment of pulmonary embolism (PE). Quantitative D-dimer assay findings have been shown to have a high negative predictive value in patients with low pretest probability of PE. Objective: Evaluate roles for clinical probability and CTA in Emergency Department (ED) patients suspected of acute PE but having a low serum D-dimer level. Design: Prospective observational study of ED patients with possible PE who underwent pulmonary CTA and had D-dimer levels ≤1.0 μg/mL. Main Outcome: Clinical probability of PE determined by ED physicians using standard published criteria; pulmonary CTAs read by initial and study radiologists kept unaware of D-dimer results. Results: In 16 months, 744 patients underwent pulmonary CTA, with 347 study participants who had a D-dimer level ≤ 1.0 μg/mL. In one participant, CTA showed a PE that was agreed on by both the initial and study radiologists. In six participants, the initial findings were reported as positive for PE but were not interpreted as positive by the study radiologist. In none of these participants was PE diagnosed on the basis of clinical probability, of findings on ancillary studies and three-month follow-up examination, or by another radiologist, unaware of findings, acting as a tiebreaker. Conclusion: Pulmonary CTA findings positive for acute embolism should be viewed with caution, especially if the suspected PE is in a distal segmental or subsegmental artery in a patient with a serum D-dimer level of ≤1.0 μg/mL. Furthermore, the Wells criteria may be of limited additional value in this group of patients with low D-dimer levels because most will have low or intermediate clinical probability of PE. PMID:20740096

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

MEASURING COERCION TO PARTICIPATE IN RESEARCH WITHIN A DOUBLY VULNERABLE POPULATION: INITIAL DEVELOPMENT OF THE COERCION ASSESSMENT SCALE

PubMed Central

Dugosh, Karen Leggett; Festinger, David S.; Croft, Jason R.; Marlowe, Douglas B.

2011-01-01

Despite many efforts aimed to ensure that research participation is autonomous and not coerced, there exists no reliable and valid measure of perceived coercion for the doubly vulnerable population of substance-abusing offenders. The current study describes the development and initial validation of an instrument measuring perceived coercion to participate in research among substance-abusing offenders. The results indicated that a substantial number of individuals report feeling coerced to participate in the study. In addition, the instrument has adequate levels of internal consistency, a one-dimensional factor structure, and evidence of discriminative validity. This study provides initial support for the instrument’s validity and clinical utility. PMID:20235867

Clinical, classroom, or personal education: attitudes about health literacy.

PubMed

Logan, Robert A

2007-04-01

This study explores how diverse attitudes about health literacy are assessed by medical librarians and other health care professionals. An online survey of thirty-six items was conducted using Q methodology in two phases in spring 2005 and winter 2006. Respondents (n = 51) were nonrandomly self-selected from a convenience sample of members of the Medical Library Association and a group of environmental health consultants to the National Library of Medicine. Three factors were identified. Factor 1 is optimistic and supportive of health literacy's transformative sociocultural and professional potential, if clinical settings become a launching point for health literacy activities. Factor 2 is less optimistic about health literacy's potential to improve clinical or patient outcomes and prefers to focus health literacy initiatives on classroom education settings. Factor 3 supports improving the nation's health literacy but tends to support health literacy initiatives when people privately interact with health information materials. Each factor's attitudes about the appropriate educational venue to initiate health literacy activities are different and somewhat mutually exclusive. This suggests that health literacy is seen through different perceptual frameworks that represent a possible source of professional disagreement.

Motion tracking to enable pre-surgical margin mapping in basal cell carcinoma using optical imaging modalities: initial feasibility study using optical coherence tomography

NASA Astrophysics Data System (ADS)

Duffy, M.; Richardson, T. J.; Craythorne, E.; Mallipeddi, R.; Coleman, A. J.

2014-02-01

A system has been developed to assess the feasibility of using motion tracking to enable pre-surgical margin mapping of basal cell carcinoma (BCC) in the clinic using optical coherence tomography (OCT). This system consists of a commercial OCT imaging system (the VivoSight 1500, MDL Ltd., Orpington, UK), which has been adapted to incorporate a webcam and a single-sensor electromagnetic positional tracking module (the Flock of Birds, Ascension Technology Corp, Vermont, USA). A supporting software interface has also been developed which allows positional data to be captured and projected onto a 2D dermoscopic image in real-time. Initial results using a stationary test phantom are encouraging, with maximum errors in the projected map in the order of 1-2mm. Initial clinical results were poor due to motion artefact, despite attempts to stabilise the patient. However, the authors present several suggested modifications that are expected to reduce the effects of motion artefact and improve the overall accuracy and clinical usability of the system.

Multiflex versus superelastic: a randomized clinical trial of the tooth alignment ability of initial arch wires.

PubMed

West, A E; Jones, M L; Newcombe, R G

1995-11-01

Two arch wires commonly used for initial tooth alignment were compared with regard to their clinical effectiveness. The two arch wires tested were 0.0155-inch diameter multiple-stranded stainless steel wire (Dentaflex, Dentaurium, Optident, Yorkshire, England) and 0.014-inch diameter nickel-titanium alloy wire (NiTi, ORMCO Co., Monrovia, Calif.). Consecutive patients attending an orthodontic clinic for routine placement of a fixed appliance were randomly assigned one of these two initial arch wires. Good quality alginate impressions of the appropriate dental arch were taken before arch wire placement and also at the subsequent appointment, which was, on average, 6 weeks later. Seventy-four arches were used in this study. The degree of tooth alignment achieved for each wire type was compared with a Reflex Microscope (Reflex Measurement Ltd., Butleigh, England) to make detailed measurements on the resultant casts. The degree of initial alignment achieved with the two wires was similar over this 6-week period. However, some differences were found for the lower labial segment where the interbracket span is usually reduced and where the superelastic nickel-titanium wire was found to give improved alignment. No threshold of crowding was found where one arch wire performed better than the other.

Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin

PubMed Central

Karyekar, C S; Frederich, R; Ravichandran, S

2013-01-01

BackgroundIn four 24-week controlled studies, the antihyperglycaemic efficacy of saxagliptin was demonstrated in patients with type 2 diabetes mellitus as add-on therapy to glyburide, a thiazolidinedione, or metformin, and when used in initial combination with metformin vs. metformin monotherapy in drug-naive patients. MethodsData from these studies were analysed to compare the proportions of patients who achieved specific reductions from baseline in glycated haemoglobin [HbA1c; reductions of ≥ 0.5% and ≥ 0.7% in all studies (prespecified); reductions ≥ 1.0% in the add-on studies and ≥ 1.0% to ≥ 2.5% in the initial combination study (post hoc)] for saxagliptin vs. comparator at week 24. We report overall rates of glycaemic response defined by these reductions in HbA1c and rates of response without experiencing hypoglycaemia. ResultsLarge glycaemic response rates were higher with saxagliptin 2.5 and 5 mg/day than with comparator (HbA1c ≥ 1.0%, 31.7–50.3% vs. 10.3–20.0%) as add-on therapy and higher with saxagliptin 5 mg/day as initial combination with metformin than with metformin monotherapy (HbA1c ≥ 2.0%, 68.3% vs. 49.8%) in drug-naive patients. Addition of saxagliptin was associated with a low incidence of hypoglycaemia; overall response rates and response rates excluding patients who experienced hypoglycaemia were similar. Analysis of several demographic and baseline clinical variables revealed no consistent correlations with response to saxagliptin. ConclusionsWhether receiving saxagliptin as an add-on therapy to glyburide, a thiazolidinedione, or metformin or in initial combination with metformin, a greater percentage of patients achieve clinically relevant large reductions in HbA1c vs. comparator, with a low incidence of hypoglycaemia. PMID:23795975

Treatment initiation and dropout from prolonged exposure and cognitive processing therapy in a VA outpatient clinic.

PubMed

Kehle-Forbes, Shannon M; Meis, Laura A; Spoont, Michele R; Polusny, Melissa A

2016-01-01

Emerging data suggest that few veterans are initiating prolonged exposure (PE) and cognitive processing therapy (CPT) and dropout levels are high among those who do start the therapies. The goal of this study was to use a large sample of veterans seen in routine clinical care to 1) report the percent of eligible and referred veterans who (a) initiated PE/CPT, (b) dropped out of PE/CPT, (c) were early PE/CPT dropouts, 2) examine predictors of PE/CPT initiation, and 3) examine predictors of early and late PE/CPT dropout. We extracted data from the medical records of 427 veterans who were offered PE/CPT following an intake at a Veterans Health Administration (VHA) PTSD Clinical Team. Eighty-two percent (n = 351) of veterans initiated treatment by attending Session 1 of PE/CPT; among those veterans, 38.5% (n = 135) dropped out of treatment. About one quarter of veterans who dropped out were categorized as early dropouts (dropout before Session 3). No significant predictors of initiation were identified. Age was a significant predictor of treatment dropout; younger veterans were more likely to drop out of treatment than older veterans. Therapy type was also a significant predictor of dropout; veterans receiving PE were more likely to drop out late than veterans receiving CPT. Findings demonstrate that dropout from PE/CPT is a serious problem and highlight the need for additional research that can guide the development of interventions to improve PE/CPT engagement and adherence. (c) 2016 APA, all rights reserved).

Thirty-Year (1975–2005) Trends in the Incidence Rates, Clinical Features, Treatment Practices, and Short-term Outcomes of Patients < 55 Years of Age Hospitalized with an Initial Acute Myocardial Infarction

PubMed Central

McManus, David D.; Piacentine, Stephen M; Lessard, Darleen; Gore, Joel M.; Yarzebski, Jorge; Spencer, Frederick A.; Goldberg, Robert J.

2011-01-01

Sparse data are available describing recent trends in the magnitude, clinical features, treatment practices, and outcomes of comparatively young adults hospitalized with acute myocardial infarction (AMI). The objectives of this population-based study were to describe 3 decade-long trends (1975–2005) in these endpoints among adults less than 55 years old who were hospitalized with an initial AMI. The study population consisted of 1,703 residents of the Worcester (MA) metropolitan area between the ages of 25–54 years who were hospitalized with an initial AMI at all central Massachusetts medical centers during 15 annual periods between 1975 and 2005. The overall hospital incidence rate (per 100,000 persons) of initial AMI in our study population was 66 (95% confidence interval 63–69) and the incidence rates of AMI declined inconsistently over time. Patients hospitalized during the most recent study years were more likely to have important cardiovascular risk factors and comorbidities present but were less likely to have developed heart failure during their index hospitalization. In-hospital and 30-day death rates declined by approximately 50% (p = 0.04) during the years under study concomitant with increasing use of effective cardiac therapies. In conclusion, the results of this community-wide investigation provide insights into the magnitude, changing characteristics, and short-term outcomes of comparatively young patients hospitalized with a first AMI. Declining odds of developing, or dying from, an initial AMI during the 30 years under study likely reflect enhanced primary and secondary prevention and treatment efforts. PMID:21624538

Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.

PubMed

Bordet, Régis; Lang, Marie; Dieu, Christelle; Billon, Nathalie; Duffet, Jean-Pierre

2015-08-19

A public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials. We performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of <15 % of trials sites without patients enrolled. In 2013, the median delay to contract signature was: 55 days, compared with 76 days in 2008 (27.6 % reduction), 50.5 % of all sites and 58 % of sites with a dedicated CRA included ≥80 % of the planned number of patients compared with 44.8 % in 2008 (12.7 % increase) and 21.3 % of all sites and 9 % of sites with a dedicated CRA closed with no patients included, compared with 26.4 % in 2008 (19.3 and 65.9 %, respectively). These results provide evidence that it is possible to improve a country's attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western Europe to improve Europe's attractiveness to industry-funded trials.

Hypnotic relaxation vs amitriptyline for tension-type headache: let the patient choose.

PubMed

Ezra, Yacov; Gotkine, Marc; Goldman, Sylvie; Adahan, Haim Moshe; Ben-Hur, Tamir

2012-05-01

Although both pharmacological and behavioral interventions may relieve tension-type headache, data are lacking regarding treatment preference, long-term patient compliance, and feasibility of behavioral intervention in a standard neurological outpatient clinic setting. To describe patient choice, long-term compliance, and clinical outcome in a neurological clinic setting where patients are given the choice of the approach they wish to pursue. Patients presenting to the headache clinic with a diagnosis of tension-type headache that justified prophylactic therapy (frequent episodic tension-type headache or chronic tension-type headache) were given the choice of amitriptyline (AMT) treatment or hypnotic relaxation (HR), and were treated accordingly. Patients were given the option to cross-over to the other treatment group at each visit. HR was performed during standard length neurology clinic appointments by a neurologist trained to perform hypnosis (Y.E.). Follow-up interviews were performed between 6 and 12 months following treatment initiation to evaluate patient compliance, changes in headache frequency or severity, and quality-of-life parameters. Ninety-eight patients were enrolled, 92 agreed to receive prophylactic therapy of some kind. Fifty-three (57.6%) patients chose HR of which 36 (67.9%) actually initiated this treatment, while 39 (42.4%) chose pharmacological therapy with AMT of which 25 (64.1%) patients actually initiated therapy. Patients with greater analgesic use were more likely to opt for AMT (P= .0002). Eleven of the patients initially choosing AMT and 2 of the patients initially choosing HR crossed over to the other group. Seventy-four percent of the patients in the HR group and 58% of patients in the AMT group had a 50% reduction in the frequency of headaches (P= .16). Long-term adherence to treatment with HR exceeded that of AMT. At the end of the study period, 26 of 47 patients who tried HR compared with 10 of 27 who tried AMT continued receiving their initial treatment. HR treatment was a more popular choice among patients. Patients choosing HR reported greater symptom relief than those choosing AMT and were found to have greater treatment compliance. Patients receiving HR were less likely to change treatments. HR practiced by a neurologist is feasible in a standard neurological outpatient clinic setting; HR training should be considered for neurologists involved in headache treatment. © 2011 American Headache Society.

Heart failure diagnosis in acute conditions has high agreement with inpatient diagnosis.

PubMed

Seronde, Marie-France; Laribi, Said; Collins, Sean P; Deye, Nicolas; Logeart, Damien; Plaisance, Patrick; Cohen-Solal, Alain; Mebazaa, Alexandre

2016-06-01

Acute heart failure (AHF) is frequently encountered in the emergency department (ED) or in the cardiac care unit (CCU)/ICU. Discrimination between cardiac and noncardiac cause of dyspnea by clinical means and standard testing is sometimes inadequate. The aim of our study was to assess AHF diagnosis agreement as determined by: (a) the attending physician, (b) the hospital discharge diagnosis, and (c) an adjudication committee. Between 2010 and 2011, consecutive patients arriving for dyspnea in our hospital were prospectively included. A convenience sample of patients was enrolled in this analysis. Patients were admitted through the ED (280 patients) or through CCU/ICU (112 patients) for undifferentiated dyspnea. Overall, few differences were observed between the initial diagnosis and the hospital discharge diagnosis or the adjudicated diagnosis. Among the 200 patients with an initial diagnosis of AHF, hospital discharge diagnosis confirmed AHF (alone or combined) in 191 (95.5%) patients and the adjudication committee confirmed AHF (alone or combined) in 196 (98%) patients. Our study showed considerable agreement between different AHF diagnostic standards. An initial AHF diagnosis on the basis of clinical signs and biological parameters utilizing B-type natriuretic peptide testing has high agreement and accuracy with the hospital discharge and adjudicated diagnosis of AHF. The present study also shows that the accuracy of the initial AHF diagnosis allows rapid inclusion in AHF trials. These results, if confirmed in a broader cohort of patients, suggest that the initial ED diagnosis is highly accurate and reliable to guide further inpatient management.

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

DTIC Science & Technology

2017-10-01

mRNA and has been shown in many studies to improve predictive accuracy for cancer on initial biopsy,3,7-9 and to be correlated with more aggressive... Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...during AS. The objective of the study is to utilize analytically validated assays that take into account tumor heterogeneity to measure biomarkers in

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

SU-F-T-261: Reconstruction of Initial Photon Fluence Based On EPID Images

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

Seliger, T; Engenhart-Cabillic, R; Czarnecki, D

2016-06-15

Purpose: Verifying an algorithm to reconstruct relative initial photon fluence for clinical use. Clinical EPID and CT images were acquired to reconstruct an external photon radiation treatment field. The reconstructed initial photon fluence could be used to verify the treatment or calculate the applied dose to the patient. Methods: The acquired EPID images were corrected for scatter caused by the patient and the EPID with an iterative reconstruction algorithm. The transmitted photon fluence behind the patient was calculated subsequently. Based on the transmitted fluence the initial photon fluence was calculated using a back-projection algorithm which takes the patient geometry andmore » its energy dependent linear attenuation into account. This attenuation was gained from the acquired cone-beam CT or the planning CT by calculating a water-equivalent radiological thickness for each irradiation direction. To verify the algorithm an inhomogeneous phantom consisting of three inhomogeneities was irradiated by a static 6 MV photon field and compared to a reference flood field image. Results: The mean deviation between the reconstructed relative photon fluence for the inhomogeneous phantom and the flood field EPID image was 3% rising up to 7% for off-axis fluence. This was probably caused by the used clinical EPID calibration, which flattens the inhomogeneous fluence profile of the beam. Conclusion: In this clinical experiment the algorithm achieved good results in the center of the field while it showed high deviation of the lateral fluence. This could be reduced by optimizing the EPID calibration, considering the off-axis differential energy response. In further progress this and other aspects of the EPID, eg. field size dependency, CT and dose calibration have to be studied to realize a clinical acceptable accuracy of 2%.« less

Clinical trial quality: From supervision to collaboration and beyond.

PubMed

Meeker-O'Connell, Ann; Glessner, Coleen

2018-02-01

Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia

PubMed Central

Franzen, Samuel R P; Chandler, Clare; Enquselassie, Fikre; Siribaddana, Sisira; Atashili, Julius; Angus, Brian; Lang, Trudie

2013-01-01

Objectives Clinical trials provide ‘gold standard’ evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. Design Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). Setting Fieldwork took place in Ethiopia during March 2011. Participants Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). Outcome measures Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. Results All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. Conclusions Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely. PMID:24285629

A Multilevel Analysis of Real-World Variations in Oral Anticoagulation Initiation for Atrial Fibrillation in Valencia, a European Region.

PubMed

García-Sempere, Aníbal; Bejarano-Quisoboni, Daniel; Librero, Julián; Rodríguez-Bernal, Clara L; Peiró, Salvador; Sanfélix-Gimeno, Gabriel

2017-01-01

Introduction: Beyond clinical trials, clinical practice guidelines, and administrative regulation, treatment decision-making can be influenced by individual and contextual factors. Our goal was to describe variations in the patterns of initiation of anticoagulation therapy in patients with atrial fibrillation by Health Areas (HA) in the region of Valencia in Spain and to quantify the influence of the HAs on variations in treatment choice. Methods: We conducted a population-based retrospective cohort study of all atrial fibrillation patients who started treatment with oral anticoagulants between November 2011 and February 2014 in each of the region's 24 HAs. We described patient and utilization characteristics per HA and initiation patterns over time, and we identified contextual and individual factors associated with differences in initiation patterns. Results: 21,879 patients initiated treatment with an oral anticoagulant in the 24 HAs. Initiation with direct oral anticoagulants (DOAC) in the first year was 14.6%. In November 2013 the ratio was 25.4%, with HA ratios ranging from 3.8 to 57.1%. DOAC-initiating patients had less comorbidity but were more likely to present episodes of previous ischemic stroke, hemorrhagic stroke, or TIA when compared with patients initiating with VKA treatment. Variability among HAs was statistically significant, with the majority of HAs ranking above or below the regional initiation average (ICC ≈ 8%). Conclusion: There was high variability in the percentage of DOAC initiation and in the choice of DOAC among HAs. Interventions aimed to improve DOAC initiation decision-making and to reduce variations should take into account the Health Area component.

A Multilevel Analysis of Real-World Variations in Oral Anticoagulation Initiation for Atrial Fibrillation in Valencia, a European Region

PubMed Central

García-Sempere, Aníbal; Bejarano-Quisoboni, Daniel; Librero, Julián; Rodríguez-Bernal, Clara L.; Peiró, Salvador; Sanfélix-Gimeno, Gabriel

2017-01-01

Introduction: Beyond clinical trials, clinical practice guidelines, and administrative regulation, treatment decision-making can be influenced by individual and contextual factors. Our goal was to describe variations in the patterns of initiation of anticoagulation therapy in patients with atrial fibrillation by Health Areas (HA) in the region of Valencia in Spain and to quantify the influence of the HAs on variations in treatment choice. Methods: We conducted a population-based retrospective cohort study of all atrial fibrillation patients who started treatment with oral anticoagulants between November 2011 and February 2014 in each of the region's 24 HAs. We described patient and utilization characteristics per HA and initiation patterns over time, and we identified contextual and individual factors associated with differences in initiation patterns. Results: 21,879 patients initiated treatment with an oral anticoagulant in the 24 HAs. Initiation with direct oral anticoagulants (DOAC) in the first year was 14.6%. In November 2013 the ratio was 25.4%, with HA ratios ranging from 3.8 to 57.1%. DOAC-initiating patients had less comorbidity but were more likely to present episodes of previous ischemic stroke, hemorrhagic stroke, or TIA when compared with patients initiating with VKA treatment. Variability among HAs was statistically significant, with the majority of HAs ranking above or below the regional initiation average (ICC ≈ 8%). Conclusion: There was high variability in the percentage of DOAC initiation and in the choice of DOAC among HAs. Interventions aimed to improve DOAC initiation decision-making and to reduce variations should take into account the Health Area component. PMID:28883793

A chance to stop and breathe: participants’ experiences in the North American Opiate Medication Initiative clinical trial

PubMed Central

2014-01-01

Background The North American Opiate Medication Initiative (NAOMI) clinical trial compared the effectiveness of injectable diacetylmorphine (DAM) or hydromorphone (HDM) to oral methadone maintenance treatment (MMT). This study aimed to determine participants’ perceptions of treatment delivered in NAOMI. Methods A qualitative sub-study was conducted with 29 participants (12 female): 18 (62.1%) received injectable DAM or HDM and 11 (37.9%) received MMT. A phenomenological theoretical framework was used. Semi-structured interviews were audio-recorded and transcribed verbatim. A thematic analysis was used over successive phases and was driven by the semantic meanings of the data. Results Participants receiving injectable medications suggested that the supervised delivery model was stringent but provided valuable stability to their lives. Females discussed the adjustment required for the clinical setting, while males focused on the challenging clinic schedule and its impact on employment abilities. Participants receiving MMT described disappointment with being randomized to this treatment; however, positive aspects, including the quick titration time and availability of auxiliary services, were also discussed. Conclusion Treatment with injectable DAM (or HDM) is preferred by participants and considered effective in reducing the burden of opioid dependency. Engaging patients in research regarding their perceptions of treatment provides a comprehensive assessment of treatment needs and barriers. Clinical trial registration NCT00175357 PMID:25262567

Clinical Evidence: a useful tool for promoting evidence-based practice?

PubMed

Formoso, Giulio; Moja, Lorenzo; Nonino, Francesco; Dri, Pietro; Addis, Antonio; Martini, Nello; Liberati, Alessandro

2003-12-23

Research has shown that many healthcare professionals have problems with guidelines as they would prefer to be given all relevant information relevant to decision-making rather than being told what they should do. This study assesses doctors' judgement of the validity, relevance, clarity and usability of the Italian translation of Clinical Evidence (CE) after its free distribution launched by the Italian Ministry of Health. Opinions elicited using a standardised questionnaire delivered either by mail or during educational or professional meetings. Twenty percent (n = 1350) doctors participated the study. Most of them found CE's content valid, useful and relevant for their clinical practice, and said CE can foster communications among clinicians, particularly among GPs and specialists. Hospital doctors (63%) more often than GPs (48%) read the detailed presentation of individual chapters. Twenty-nine percent said CE brought changes in their clinical practice. Doctors appreciated CE's nature of an evidence-based information compendium and would have not preferred a collection of practice guidelines. Overall, the pilot initiative launched by the Italian Ministry of Health seems to have been well received and to support the subsequent decision to make the Italian edition of Clinical Evidence concise available to all doctors practising in the country. Local implementation initiatives should be warranted to favour doctor's use of CE.

Loss to follow-up before and after initiation of antiretroviral therapy in HIV facilities in Lilongwe, Malawi.

PubMed

Tweya, Hannock; Oboho, Ikwo Kitefre; Gugsa, Salem T; Phiri, Sam; Rambiki, Ethel; Banda, Rebecca; Mwafilaso, Johnbosco; Munthali, Chimango; Gupta, Sundeep; Bateganya, Moses; Maida, Alice

2018-01-01

Although several studies have explored factors associated with loss to follow-up (LTFU) from HIV care, there remains a gap in understanding how these factors vary by setting, volume of patient and patients' demographic and clinical characteristics. We determined rates and factors associated with LTFU in HIV care Lilongwe, Malawi. We conducted a retrospective cohort study of HIV-infected individuals aged 15 years or older at the time of registration for HIV care in 12 ART facilities, between April 2012 and March 2013. HIV-positive individuals who had not started ART (pre-ART patients) were clinically assessed to determine ART eligibility at registration and during clinic follow-up visits. ART-eligible patients were initiated on triple antiretroviral combination. Study data were abstracted from patients' cards, facility ART registers or electronic medical record system from the date of registration for HIV care to a maximum follow-up period of 24 months. Descriptive statistics were undertaken to summarize characteristics of the study patients. Separate univariable and multivariable poisson regression models were used to explore factors associated with LTFU in pre-ART and ART care. A total of 10,812 HIV-infected individuals registered for HIV care. Of these patients, 1,907 (18%) and 8,905 (82%) enrolled in pre-ART and ART care, respectively. Of the 1,907 pre-ART patients, 490 (26%) subsequently initiated ART and were included in both the pre-ART and ART analyses. The LTFU rates among patients in pre-ART and ART care were 48 and 26 per 100 person-years, respectively. Of the 9,105 ART patients with reasons for starting ART, 2,451 (27%) were initiated on ART because of pregnancy or breastfeeding (Option B+) status. Multivariable analysis showed that being ≥35 years and female were associated with decreased risk of LTFU in the pre-ART and ART phases of HIV care. However, being in WHO clinical stage 3 (adjusted risk ratio (aRR) 1.35, 95% confidence interval (CI): 1.20-1.51) and stage 4 (aRR 1.87, 95% CI: 1.62-2.18), body mass index ≤ 18.4 (aRR 1.24, 95% CI: 1.11-1.39) at ART initiation, poor adherence to clinic appointments (aRR 4.55, 95% CI: 4.16-4.97) and receiving HIV care in rural facilities (aRR 2.32, 95% CI: 1.94-2.87) were associated with increased risk of LTFU among ART patients. Being re-initiated on ART once (aRR 0.20, 95% CI: 0.17-0.22), more than once (aRR 0.06, 95% CI: 0.05-0.07), and being enrolled at a low-volume facility (aRR 0.25, 95% CI: 0.20-0.30) were associated with decreased risk of LTFU from ART care. A sizeable proportion of ART LTFU occurred among women enrolled during pregnancy or breast-feeding. Non- compliance to clinic and receiving ART in a rural facility or high-volume facility were associated with increased risk of LTFU from ART care. Developing effective interventions that target high-risk subgroups and contexts may help reduce LTFU from HIV care.

The factors associated with longitudinal changes in liver stiffness in patients with chronic hepatitis B

PubMed Central

Yo, In Ku; Park, Jin Woong; Lee, Jong Joon; Lee, Jung Hyun; Won, In Sik; Na, Sun Young; Jang, Pil Kyu; Park, Pyung Hwa; Choi, Duck Joo; Kim, Yun Soo; Kim, Ju Hyun

2015-01-01

Background/Aims Liver stiffness (LS) as assessed by transient elastography (TE) can change longitudinally in patients with chronic hepatitis B (CHB). The aim of this study was to identify the factors that improve LS. Methods Between April 2007 and December 2012, 151 patients with CHB who underwent two TE procedures with an interval of about 2 years were enrolled. Ninety-six of the 151 patients were treated with nucleos(t)ide analogues [the antiviral therapy (+) group], while the remaining 55 patients were not [the antiviral therapy (-) group]. The two groups of patients were stratified according to whether they exhibited an improvement or a deterioration in LS during the study period (defined as an LS change of ≤0 or >0 kPa, respectively, over a 1-year period), and their data were compared. Results No differences were observed between the antiviral therapy (+) and (-) groups with respect to either their clinical characteristics or their initial LS. The observed LS improvement was significantly greater in the antiviral therapy (+) group than in the antiviral therapy (-) group (-3.0 vs. 0.98 kPa, P=0.011). In the antiviral therapy (+) group, the initial LS was higher in the LS improvement group (n=63) than in the LS deterioration group (n=33; 7.9 vs. 4.8 kPa, P<0.001). However, there were no differences in any other clinical characteristic. In the antiviral therapy (-) group, the initial LS was also higher in the LS improvement group (n=29) than in the LS deterioration group (n=26; 8.3 vs. 6.5 kPa, P=0.021), with no differences in any other clinical characteristic. Conclusions A higher initial LS was the only factor associated with LS improvement in patients with CHB in this study. PMID:25834800

The factors associated with longitudinal changes in liver stiffness in patients with chronic hepatitis B.

PubMed

Yo, In Ku; Kwon, Oh Sang; Park, Jin Woong; Lee, Jong Joon; Lee, Jung Hyun; Won, In Sik; Na, Sun Young; Jang, Pil Kyu; Park, Pyung Hwa; Choi, Duck Joo; Kim, Yun Soo; Kim, Ju Hyun

2015-03-01

Liver stiffness (LS) as assessed by transient elastography (TE) can change longitudinally in patients with chronic hepatitis B (CHB). The aim of this study was to identify the factors that improve LS. Between April 2007 and December 2012, 151 patients with CHB who underwent two TE procedures with an interval of about 2 years were enrolled. Ninety-six of the 151 patients were treated with nucleos(t)ide analogues [the antiviral therapy (+) group], while the remaining 55 patients were not [the antiviral therapy (-) group]. The two groups of patients were stratified according to whether they exhibited an improvement or a deterioration in LS during the study period (defined as an LS change of ≤0 or >0 kPa, respectively, over a 1-year period), and their data were compared. No differences were observed between the antiviral therapy (+) and (-) groups with respect to either their clinical characteristics or their initial LS. The observed LS improvement was significantly greater in the antiviral therapy (+) group than in the antiviral therapy (-) group (-3.0 vs. 0.98 kPa, P=0.011). In the antiviral therapy (+) group, the initial LS was higher in the LS improvement group (n=63) than in the LS deterioration group (n=33; 7.9 vs. 4.8 kPa, P<0.001). However, there were no differences in any other clinical characteristic. In the antiviral therapy (-) group, the initial LS was also higher in the LS improvement group (n=29) than in the LS deterioration group (n=26; 8.3 vs. 6.5 kPa, P=0.021), with no differences in any other clinical characteristic. A higher initial LS was the only factor associated with LS improvement in patients with CHB in this study.

Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

PubMed

Beran, Roy G

2004-01-01

Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal obligations were addressed in a fashion which allowed the conduct of a trial adopting a proven methodology but novel infrastructure such that it was a totally independent study with regards conduct and reporting of final data, irrespective of the results being either positive or negative. This may represent a more acceptable way to ensure that future clinical trials are devoid of undue influence from the pharmaceutical industry which may still fund the study.

The utilization of a non-invasive fluorescence imaging system to follow clinical dermatological MAL-PDT

NASA Astrophysics Data System (ADS)

Tyrrell, Jessica; Campbell, Sandra; Curnow, Alison

2009-06-01

This study employed a commercially available, non-invasive, fluorescence imaging system (Dyaderm, Biocam, Germany), to measure protoporphyrin IX (PpIX) concentration at several different stages during clinical dermatological methyl aminolevulinate photodynamic therapy (MAL-PDT). We validated the system prior to use to ensure that the PpIX changes witnessed were accurate and not due to environmental or user induced artifacts. The system was then employed to acquire color (morphological) and fluorescent (physiological) images simultaneously during dermatological PDT. Clinical data was collected from a range of licensed dermatological conditions (actinic keratosis, Bowen's disease and superficial basal cell carcinoma) during initial and subsequent PDT treatment cycles. The initial clinical data indicated that each type of licensed lesion considered responded in a similar manner following the application of Metvix (Galderma, U.K.) and the subsequent light irradiation (Aktilite, Galderma, U.K.). Images acquired three hours after Metvix application showed a significant increase in PpIX concentration within the lesion (P < 0.05), whilst PpIX levels in the surrounding normal tissue remained unaltered. After irradiation, the PpIX concentration was significantly decreased and returned to a level similar to the initial concentration originally observed. Lesions that received subsequent treatment cycles accumulated significantly less PpIX (P < 0.05) prior to irradiation.

Fever, Haematuria, and Acute Graft Dysfunction in Renal Transplant Recipients Secondary to Adenovirus Infection: Two Case Reports

PubMed Central

Ramírez, J.; Bostock, I. C.; Martin-Onraët, A.; Calleja, S.; Sánchez-Cedillo, A.; Navarro-Vargas, L. A.; Noriega-Salas, A. L.; Martínez-Mijangos, O.; Uribe-Uribe, N. O.; Vilatoba, M.; Gabilondo, B.; Morales-Buenrostro, L. E.; Alberú, J.

2013-01-01

We report two cases of adenoviral infection in kidney transplant recipients that presented with different clinical characteristics under similar demographic and posttransplant conditions. The first case presented with fever, gross haematuria, and acute graft dysfunction 15 days following renal transplantation. A graft biopsy, analyzed with immunohistochemistry, yielded negative results. However, the diagnosis was confirmed with blood and urine real-time PCR for adenovirus 3 days after the initial clinical manifestations. The immunosuppression dose was reduced, and ribavirin treatment was started, for which the patient quickly developed toxicity. Antiviral treatment allowed for transient response; however, a relapse occurred. The viral real-time PCR became negative upon immunosuppression reduction and administration of IVIG; graft function normalized. In the second case, the patient presented with fever and dysuria 1 month after transplantation. The initial imaging studies revealed graft enlargement and areas of hypoperfusion. In this case, the diagnosis was also confirmed with blood and urine real-time PCR for adenovirus 3 days after the initial clinical manifestations. Adenoviral nephritis was confirmed through a graft biopsy analyzed with light microscopy, immunohistochemistry, and PCR in frozen tissue. The immunosuppression dose was reduced, and IVIG was administered obtaining excellent clinical results along with a negative real-time PCR. PMID:24558620

Doses of olanzapine, risperidone, and haloperidol used in clinical practice: results of a prospective pharmacoepidemiologic study. EFESO Study Group. Estudio Farmacoepidemiologico en la Esquizofrenia con Olanzapina.

PubMed

Sacristán, J A; Gómez, J C; Montejo, A L; Vieta, E; Gregor, K J

2000-05-01

The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score < or = 4. A total of 2657 patients were included in the analysis. The initial and overall mean daily doses for the 3 groups were as follows: OLZ, 12.2 and 13.0 mg, respectively; RIS, 5.2 and 5.4 mg; and HAL, 13.9 and 13.6 mg. Initial and overall median daily doses were the same in each group: OLZ, 10 mg; RIS, 6 mg; and HAL, 10 mg. A significantly lower proportion of OLZ-treated patients (36.9%) experienced EPS compared with RIS-treated (49.6%) and HAL-treated (76.0%) patients (P < or = 0.001). A significantly lower proportion of patients in the OLZ group (47.8%) experienced adverse events compared with patients in the RIS (57.2%) and HAL (79.8%) groups (P < or = 0.001). A significantly greater proportion of OLZ-treated patients (37.3%) were responders compared with RIS-treated patients (31.5%) (P < 0.05). In all 3 groups, patients who had an initial CGI score > or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

Cost-effectiveness of apixaban versus low molecular weight heparin/vitamin k antagonist for the treatment of venous thromboembolism and the prevention of recurrences.

PubMed

Lanitis, Tereza; Leipold, Robert; Hamilton, Melissa; Rublee, Dale; Quon, Peter; Browne, Chantelle; Cohen, Alexander T

2017-01-23

Prior analyses beyond clinical trials are yet to evaluate the projected lifetime benefit of apixaban treatment compared to low-molecular-weight heparin (LMWH)/vitamin K antagonist (VKA) for treatment of venous thromboembolism (VTE) and prevention of recurrences. The objective of this study is to assess the cost-effectiveness of initial plus extended treatment with apixaban versus LMWH/VKA for either initial treatment only or initial plus extended treatment. A Markov cohort model was developed to evaluate the lifetime clinical and economic impact of treatment of VTE and prevention of recurrences with apixaban (starting at 10 mg BID for 1 week, then 5 mg BID for 6 months, then 2.5 mg BID for an additional 12 months) versus LMWH/VKA for 6 months and either no further treatment or extended treatment with VKA for an additional 12 months. Clinical event rates to inform the model were taken from the AMPLIFY and AMPLIFY-EXT trials and a network meta-analysis. Background mortality rates, costs, and utilities were obtained from published sources. The analysis was conducted from the perspective of the United Kingdom National Health Service. The evaluated outcomes included the number of events avoided in a 1000-patient cohort, total costs, life-years, quality-adjusted life-years (QALYs), and cost per QALY gained. Initial plus extended treatment with apixaban was superior to both treatment durations of LMWH/VKA in reducing the number of bleeding events, and was superior to initial LMWH/VKA for 6 months followed by no therapy, in reducing VTE recurrences. Apixaban treatment was cost-effective compared to 6-month treatment with LMWH/VKA at an incremental cost-effectiveness ratio (ICER) of £6692 per QALY. When initial LMWH/VKA was followed by further VKA therapy for an additional 12 months (i.e., total treatment duration of 18 months), apixaban was cost-effective at an ICER of £8528 per QALY gained. Sensitivity analysis suggested these findings were robust over a wide range of inputs and scenarios for the model. In the UK, initial plus extended treatment with apixaban for treatment of VTE and prevention of recurrences appears to be economical and a clinically effective alternative to LMWH/VKA, whether used for initial or initial plus extended treatment.

Teleretinal screening for diabetic retinopathy in six Los Angeles urban safety-net clinics: initial findings.

PubMed

Ogunyemi, Omolola; Terrien, Elizabeth; Eccles, Alicia; Patty, Lauren; George, Sheba; Fish, Allison; Teklehaimanot, Senait; Ilapakurthi, Ramarao; Aimiuwu, Otaren; Baker, Richard

2011-01-01

Diabetic retinopathy is a leading cause of blindness in US adults. This paper presents initial results of a teleretinal screening project for diabetic retinopathy involving six Los Angeles safety net clinics. A total of 1,943 patients have been screened for diabetic retinopathy by three ophthalmologist readers, with 416 receiving a recommendation for referral to specialty care. Of the cases recommended for referral, 24 had proliferative diabetic retinopathy, 62 had severe non-proliferative diabetic retinopathy (NPDR), 60 had moderate NPDR, 19 had mild NPDR, 138 had a non-diabetic condition, such as glaucoma, 63 had clinically significant macular edema without retinopathy and 50 had non-gradable images. Between 3% and 12.2% of retinal images taken at the clinics were assessed by readers as inadequate for any interpretation. The study shows the feasibility and challenges of teleretinal screening for diabetic retinopathy in urban areas facing specialist shortages and an overburdened, under-resourced safety net care-delivery system.

Correlates of having never been HIV tested among entrants to substance abuse treatment clinics: empiric findings from real-world New England settings.

PubMed

Chadwick, Jeanne J; Andrade, Leonardo F; Altice, Frederick L; Petry, Nancy M

2014-01-01

Routine testing is the cornerstone to identifying HIV, but not all substance abuse treatment patients have been tested. This study is a real-world evaluation of predictors of having never been HIV tested among patients initiating substance abuse treatment. Participants (N = 614) from six New England clinics were asked whether they had ever been HIV tested. Eighty-five patients (13.8%) reported having never been tested and were compared to those who had undergone testing. Clinic, male gender (adjusted odds ratio (AOR) = 1.91, 95% confidence interval (CI) = 1.07-3.41), and having fewer employment (AOR = 0.31; 95% CI = 0.11-0.88) and medical problems (AOR = 0.40, 95% CI = 0.17-0.99) were independently correlated with having never been HIV tested. Thus, there is still considerable room for improved testing strategies as a clinically significant minority of substance abuse patients have never undergone HIV testing when they initiate treatment.

Salvage microbiology: opportunities and challenges in the detection of bacterial pathogens following initiation of antimicrobial treatment

PubMed Central

Farrell, John J.; Hujer, Andrea M.; Sampath, Rangarajan; Bonomo, Robert A.

2015-01-01

Broad-range 16S ribosomal RNA gene PCR coupled with Sanger sequencing was originally employed by soil scientists and was subsequently adapted for clinical applications. PCR coupled with electrospray ionization mass spectrometry has also progressed from initial applications in the detection of organisms from environmental samples into the clinical realm and has demonstrated promise in detection of pathogens in clinical specimens obtained from patients with suspected infection but negative cultures. We review studies of multiplex PCR, 16S ribosomal RNA gene PCR and sequencing and PCR coupled with electrospray ionization mass spectrometry for detection of bacteria in specimens that were obtained from patients during or after administration of antibiotic treatment, and examine the role of each for assisting in antimicrobial treatment and stewardship efforts. Following an exploration of the available data in this field we discuss the opportunities that the preliminary investigations reveal, as well as the challenges faced with implementation of these strategies in clinical practice. PMID:25523281

Teleretinal Screening for Diabetic Retinopathy in Six Los Angeles Urban Safety-Net Clinics: Initial Findings

PubMed Central

Ogunyemi, Omolola; Terrien, Elizabeth; Eccles, Alicia; Patty, Lauren; George, Sheba; Fish, Allison; Teklehaimanot, Senait; Ilapakurthi, Ramarao; Aimiuwu, Otaren; Baker, Richard

2011-01-01

Diabetic retinopathy is a leading cause of blindness in US adults. This paper presents initial results of a teleretinal screening project for diabetic retinopathy involving six Los Angeles safety net clinics. A total of 1,943 patients have been screened for diabetic retinopathy by three ophthalmologist readers, with 416 receiving a recommendation for referral to specialty care. Of the cases recommended for referral, 24 had proliferative diabetic retinopathy, 62 had severe non-proliferative diabetic retinopathy (NPDR), 60 had moderate NPDR, 19 had mild NPDR, 138 had a non-diabetic condition, such as glaucoma, 63 had clinically significant macular edema without retinopathy and 50 had non-gradable images. Between 3% and 12.2% of retinal images taken at the clinics were assessed by readers as inadequate for any interpretation. The study shows the feasibility and challenges of teleretinal screening for diabetic retinopathy in urban areas facing specialist shortages and an overburdened, under-resourced safety net care-delivery system. PMID:22195163

Can the theoretical domains framework account for the implementation of clinical quality interventions?

PubMed

Lipworth, Wendy; Taylor, Natalie; Braithwaite, Jeffrey

2013-12-21

The health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions. We conducted a thematic synthesis of the qualitative literature exploring clinicians' perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF. Our results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions. The TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any obvious differences between different kinds of clinical quality interventions, our findings support an initially broad approach to identifying barriers and facilitators, followed by a "drilling down" to what is most contextually salient. In future, it may be possible to establish a model of clinical quality policy implementation using the TDF.

Can the theoretical domains framework account for the implementation of clinical quality interventions?

PubMed Central

2013-01-01

Background The health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions. Methods We conducted a thematic synthesis of the qualitative literature exploring clinicians’ perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF. Results Our results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions. Conclusions The TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any obvious differences between different kinds of clinical quality interventions, our findings support an initially broad approach to identifying barriers and facilitators, followed by a “drilling down” to what is most contextually salient. In future, it may be possible to establish a model of clinical quality policy implementation using the TDF. PMID:24359085

Use of Standardized Assessment Tools to Improve the Effectiveness of Palliative Care Rounds: A Quality Improvement Initiative.

PubMed

Spaner, Donna; Caraiscos, Valerie B; Muystra, Christina; Furman, Margaret Lynn; Zaltz-Dubin, Jodi; Wharton, Marilyn; Whitehead, Katherine

Optimal care for patients in the palliative care setting requires effective clinical teamwork. Communication may be challenging for health-care workers from different disciplines. Daily rounds are one way for clinical teams to share information and develop care plans for patients. The objective of this initiative was to improve the structure and process of daily palliative care rounds by incorporating the use of standardized tools and improved documentation into the meeting. We chose a quality improvement (QI) approach to address this initiative. Our aims were to increase the use of assessment tools when discussing patient care in rounds and to improve the documentation and accessibility of important information in the health record, including goals of care. This QI initiative used a preintervention and postintervention comparison of the outcome measures of interest. The initiative was tested in a palliative care unit (PCU) over a 22-month period from April 2014 to January 2016. Participants were clinical staff in the PCU. Data collected after the completion of several plan-do-study-act cycles showed increased use and incorporation of the Edmonton Symptom Assessment System and Palliative Performance Scale into patient care discussions as well as improvement in inclusion of goals of care into the patient plan of care. Our findings demonstrate that the effectiveness of daily palliative care rounds can be improved by incorporating the use of standard assessment tools and changes into the meeting structure to better focus and direct patient care discussions.

Clinical significance of In vivo Cytarabine Induced Gene Expression Signature in AML

PubMed Central

Lamba, Jatinder K.; Pounds, Stanley; Cao, Xueyuan; Crews, Kristine R.; Cogle, Christopher R.; Bhise, Neha; Raimondi, Susana C.; Downing, James R.; Baker, Sharyn D.; Ribeiro, Raul C.; Rubnitz, Jeffrey E.

2016-01-01

Despite initial remission, approximately 60-70% of adult and 30% of pediatric patients experience relapse or refractory AML. Studies so far have identified base line gene expression profiles of pathogenic and prognostic significance in AML, however extent of change in gene expression post-initiation of treatment has not been investigated. Exposure of leukemic cells to chemotherapeutic agents such as cytarabine, a mainstay of AML chemotherapy can trigger adaptive response by influencing leukemic cell transcriptome and hence development of resistance or refractory disease. It is however challenging to perform such a study due to lack of availability of specimens post-drug treatment. In this study our primary objective was to identify in vivo cytarabine induced changes in leukemia cell transcriptome and to evaluate their impact on clinical outcome. Our results highlight genes relevant to cytarabine resistance and support the concept of targeting cytarabine-induced genes as a means of improving response. PMID:26366682

Clinical significance of in vivo cytarabine-induced gene expression signature in AML.

PubMed

Lamba, Jatinder K; Pounds, Stanley; Cao, Xueyuan; Crews, Kristine R; Cogle, Christopher R; Bhise, Neha; Raimondi, Susana C; Downing, James R; Baker, Sharyn D; Ribeiro, Raul C; Rubnitz, Jeffrey E

2016-01-01

Despite initial remission, ∼60-70% of adult and 30% of pediatric patients experience relapse or refractory AML. Studies so far have identified base line gene expression profiles of pathogenic and prognostic significance in AML; however, the extent of change in gene expression post-initiation of treatment has not been investigated. Exposure of leukemic cells to chemotherapeutic agents such as cytarabine, a mainstay of AML chemotherapy, can trigger adaptive response by influencing leukemic cell transcriptome and, hence, development of resistance or refractory disease. It is, however, challenging to perform such a study due to lack of availability of specimens post-drug treatment. The primary objective of this study was to identify in vivo cytarabine-induced changes in leukemia cell transcriptome and to evaluate their impact on clinical outcome. The results highlight genes relevant to cytarabine resistance and support the concept of targeting cytarabine-induced genes as a means of improving response.

A Pilot Survey of Patient-Initiated Assaults on Medical Students during Clinical Clerkship

ERIC Educational Resources Information Center

Waddell, Andrea E.; Katz, Mark R.; Lofchy, Jodi; Bradley, John

2005-01-01

Objectives: To assess the incidents of patient-initiated assault (PIA) against clinical clerks during the first six months of clinical clerkship. To characterise the assaults with respect to service, location, clerk gender, patient gender. To examine the students' perceptions of the reporting process for PIA. Methods: A brief email survey was sent…

Redesign of a university hospital preanesthesia evaluation clinic using a queuing theory approach.

PubMed

Zonderland, Maartje E; Boer, Fredrik; Boucherie, Richard J; de Roode, Annemiek; van Kleef, Jack W

2009-11-01

Changes in patient length of stay (the duration of 1 clinic visit) as a result of the introduction of an electronic patient file system forced an anesthesia department to change its outpatient clinic organization. In this study, we sought to demonstrate how the involvement of essential employees combined with mathematical techniques to support the decision-making process resulted in a successful intervention. The setting is the preanesthesia evaluation clinic (PAC) of a university hospital, where patients consult several medical professionals, either by walk-in or appointment. Queuing theory was used to model the initial set-up of the clinic, and later to model possible alternative designs. With the queuing model, possible improvements in efficiency could be investigated. Inputs to the model were patient arrival rates and expected service times with clinic employees, collected from the clinic's logging system and by observation. The performance measures calculated with the model were patient length of stay and employee utilization rate. Supported by the model outcomes, a working group consisting of representatives of all clinic employees decided whether the initial design should be maintained or an intervention was needed. The queuing model predicted that 3 of the proposed alternatives would result in better performance. Key points in the intervention were the rescheduling of appointments and the reallocation of tasks. The intervention resulted in a shortening of the time the anesthesiologist needed to decide upon approving the patient for surgery. Patient arrivals increased sharply over 1 yr by more than 16%; however, patient length of stay at the clinic remained essentially unchanged. If the initial set-up of the clinic would have been maintained, the patient length of stay would have increased dramatically. Queuing theory provides robust methods to evaluate alternative designs for the organization of PACs. In this article, we show that queuing modeling is an adequate approach for redesigning processes in PACs.

Clinical manifestations of treatment-naive patients with acquired immunodeficiency syndrome and responses to highly active antiretroviral therapy in the Taipei Veterans General Hospital: a 5-year prospective study.

PubMed

Hsu, Shih-Fen; Yang, Su-Pen; Chan, Yu-Jiun; Wang, Yung-Wei

2011-06-01

Taipei Veterans General Hospital, one of the medical centers in Taiwan, has provided highly active antiretroviral therapy (HAART) to human immunodeficiency virus/AIDS patients for more than 10 years. Five years ago, we began a prospective follow-up of our patients' clinical manifestations and responses to HAART by collecting their clinical data. In this study, we analyzed the morbidity, mortality, and responses to HAART of treatment-naive AIDS patients. The purpose was to provide local data that may be valuable in Taiwan. Study cases were enrolled from January 1, 2004, to February 28, 2009, with inclusion criteria of newly diagnosed AIDS during hospitalization and being naive to HAART. Antiretroviral therapy was initiated. To evaluate the clinical responses to HAART, we excluded patients who were pregnant, died within 1 month after confirmation of an AIDS diagnosis, failed to initiate HAART, or were lost to follow-up for more than 6 months. Plasma viral loads and CD4(+) counts were quantified by reverse-transcriptase polymerase chain reaction and flow cytometry, respectively. Statistical analysis was performed using SPSS statistical software. A total of 49 patients were enrolled and 45 patients fulfilled the inclusion criteria for evaluating the efficacy of HAART. At 3 months, 12 months, and 30 months after the initiation of HAART, 64.4% (29 of 45), 88.2% (30 of 34), and 93.8% (15 of 16) had undetectable plasma viral loads, respectively, and 37.8% (17 of 45), 73.5% (25 of 34), and 81.2% (13 of 16) had CD4(+) counts of more than 200 cells/μL, respectively. Median CD4(+) counts increased from baseline at Month 3 by 171 cells/μL and at Month 30 by 375 cells/μL. The overall mortality was 22.4% (11 of 49). The virologic and immunologic responses after initiating HAART in this study demonstrated our achievements in providing care and treatment for AIDS patients during this 5-year period, which provides a strong evidence of the efficacy of HAART. Copyright © 2011. Published by Elsevier B.V.

Drug addicts seeking treatment after the Iranian Revolution: a clinic-based study.

PubMed

Dalvand, S; Agahi, C; Spencer, C

1984-09-01

A sample survey of 200 addicts attending the Rehabilitation Centre at Shiraz was conducted after the 1979 Iranian Revolution had disrupted both drug supply and addict treatment programmes. The study showed that clinics were, after the revolution, seeing a broader social range of addicts than before; and that action by the authorities was bringing many recently-addicted individuals to clinics. Heroin use predominated among those who were urban residents, whilst villagers were more likely to be opium users. The survey also sought the addicts' perceptions of the reasons for their initiation and addiction.

Building clinicians-researchers partnerships: lessons from diverse natural settings and practice-oriented initiatives.

PubMed

Castonguay, Louis G; Youn, Soo Jeong; Xiao, Henry; Muran, J Christopher; Barber, Jacques P

2015-01-01

In this concluding paper, we identify the type of studies conducted by 11 teams of contributors to a special issue on building clinicians-researchers partnerships. Those studies were conducted across a variety of clinical settings. We also integrate the lessons that have emerged from their collaborative initiatives in terms of obstacles faced, strategies adopted to address these challenges, benefits gained, and general recommendations offered to facilitate studies conducted with or by clinicians. The paper ends with the authors' thoughts about the future success of practice-oriented research in general.

[Pathogenetic relationship between pterygium and dry eye syndrome (clinical and cytological study)].

PubMed

Petraevskiĭ, A V; Trishkin, K S

2014-01-01

To study the prevalence of dry eye syndrome in patients with initial primary pterygium for determination of a possible pathogenetic role of dry eye syndrome in the development of pterygium. 30 patients with initial primary pterygium; besides conventional ophthalmic assessment, cytological examination of bulbar conjunctiva was performed in all cases. Signs of dry eye syndrome, of similar severity in both eyes, were found in 100% of patients. Dry eye can be one of the precipitating factors of primary pterygium.

DianaHealth.com, an On-Line Database Containing Appraisals of the Clinical Value and Appropriateness of Healthcare Interventions: Database Development and Retrospective Analysis.

PubMed

Bonfill, Xavier; Osorio, Dimelza; Solà, Ivan; Pijoan, Jose Ignacio; Balasso, Valentina; Quintana, Maria Jesús; Puig, Teresa; Bolibar, Ignasi; Urrútia, Gerard; Zamora, Javier; Emparanza, José Ignacio; Gómez de la Cámara, Agustín; Ferreira-González, Ignacio

2016-01-01

To describe the development of a novel on-line database aimed to serve as a source of information concerning healthcare interventions appraised for their clinical value and appropriateness by several initiatives worldwide, and to present a retrospective analysis of the appraisals already included in the database. Database development and a retrospective analysis. The database DianaHealth.com is already on-line and it is regularly updated, independent, open access and available in English and Spanish. Initiatives are identified in medical news, in article references, and by contacting experts in the field. We include appraisals in the form of clinical recommendations, expert analyses, conclusions from systematic reviews, and original research that label any health care intervention as low-value or inappropriate. We obtain the information necessary to classify the appraisals according to type of intervention, specialties involved, publication year, authoring initiative, and key words. The database is accessible through a search engine which retrieves a list of appraisals and a link to the website where they were published. DianaHealth.com also provides a brief description of the initiatives and a section where users can report new appraisals or suggest new initiatives. From January 2014 to July 2015, the on-line database included 2940 appraisals from 22 initiatives: eleven campaigns gathering clinical recommendations from scientific societies, five sets of conclusions from literature review, three sets of recommendations from guidelines, two collections of articles on low clinical value in medical journals, and an initiative of our own. We have developed an open access on-line database of appraisals about healthcare interventions considered of low clinical value or inappropriate. DianaHealth.com could help physicians and other stakeholders make better decisions concerning patient care and healthcare systems sustainability. Future efforts should be focused on assessing the impact of these appraisals in the clinical practice.

DianaHealth.com, an On-Line Database Containing Appraisals of the Clinical Value and Appropriateness of Healthcare Interventions: Database Development and Retrospective Analysis

PubMed Central

Bonfill, Xavier; Osorio, Dimelza; Solà, Ivan; Pijoan, Jose Ignacio; Balasso, Valentina; Quintana, Maria Jesús; Puig, Teresa; Bolibar, Ignasi; Urrútia, Gerard; Zamora, Javier; Emparanza, José Ignacio; Gómez de la Cámara, Agustín; Ferreira-González, Ignacio

2016-01-01

Objective To describe the development of a novel on-line database aimed to serve as a source of information concerning healthcare interventions appraised for their clinical value and appropriateness by several initiatives worldwide, and to present a retrospective analysis of the appraisals already included in the database. Methods and Findings Database development and a retrospective analysis. The database DianaHealth.com is already on-line and it is regularly updated, independent, open access and available in English and Spanish. Initiatives are identified in medical news, in article references, and by contacting experts in the field. We include appraisals in the form of clinical recommendations, expert analyses, conclusions from systematic reviews, and original research that label any health care intervention as low-value or inappropriate. We obtain the information necessary to classify the appraisals according to type of intervention, specialties involved, publication year, authoring initiative, and key words. The database is accessible through a search engine which retrieves a list of appraisals and a link to the website where they were published. DianaHealth.com also provides a brief description of the initiatives and a section where users can report new appraisals or suggest new initiatives. From January 2014 to July 2015, the on-line database included 2940 appraisals from 22 initiatives: eleven campaigns gathering clinical recommendations from scientific societies, five sets of conclusions from literature review, three sets of recommendations from guidelines, two collections of articles on low clinical value in medical journals, and an initiative of our own. Conclusions We have developed an open access on-line database of appraisals about healthcare interventions considered of low clinical value or inappropriate. DianaHealth.com could help physicians and other stakeholders make better decisions concerning patient care and healthcare systems sustainability. Future efforts should be focused on assessing the impact of these appraisals in the clinical practice. PMID:26840451

A web-based screening and accrual strategy for a cancer prevention clinical trial in healthy smokers.

PubMed

Mohebati, Arash; Knutson, Allison; Zhou, Xi Kathy; Smith, Judith J; Brown, Powel H; Dannenberg, Andrew J; Szabo, Eva

2012-09-01

Screening and recruitment of qualified subjects for clinical trials is an essential component of translational research, and it can be quite challenging if the most efficient recruitment method is not utilized. In this report, we describe a successful web-based screening and accrual method used in a randomized prospective chemoprevention clinical trial with urinary biomarker endpoints. The targeted study population was a group of at-risk healthy current smokers with no evidence of lung disease. Craigslist was used as the sole recruitment modality for this study. All interested subjects were directed to a pre-screening website, in which subject questionnaire responses were linked to the study coordinator's secure e-mail account. Of the 429 initial inquiries, 189 individuals were initially eligible based on the questionnaire response. One hundred twenty-two people were telephone-screened, of whom 98 subjects were consented, 84 were randomized and 77 subjects completed the study successfully. Utilizing this single web-based advertising strategy, accrual for the trial was completed 7 months prior to the projected date. Craigslist is a cost effective and efficient web-based resource that can be utilized in accruing subjects to some chemoprevention trials. Published by Elsevier Inc.

A web-based screening and accrual strategy for a cancer prevention clinical trial in healthy smokers

PubMed Central

Mohebati, Arash; Knutson, Allison; Zhou, Xi Kathy; Smith, Judith J.; Brown, Powel H.; Dannenberg, Andrew J.; Szabo, Eva

2012-01-01

Screening and recruitment of qualified subjects for clinical trials is an essential component of translational research, and it can be quite challenging if the most efficient recruitment method is not utilized. In this report, we describe a successful web-based screening and accrual method used in a randomized prospective chemoprevention clinical trial with urinary biomarker endpoints. The targeted study population was a group of at-risk healthy current smokers with no evidence of lung disease. Craigslist was used as the sole recruitment modality for this study. All interested subjects were directed to a pre-screening website, in which subject questionnaire responses were linked to the study coordinator's secure e-mail account. Of the 429 initial inquiries, 189 individuals were initially eligible based on the questionnaire response. One hundred twenty-two people were telephone-screened, of whom 98 subjects were consented, 84 were randomized and 77 subjects completed the study successfully. Utilizing this single web-based advertising strategy, accrual for the trial was completed 7 months prior to the projected date. Craigslist is a cost effective and efficient web-based resource that can be utilized in accruing subjects to some chemoprevention trials. PMID:22771576

A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison

ERIC Educational Resources Information Center

Gordon, Michael S.; Kinlock, Timothy W.; Couvillion, Kathryn A.; Schwartz, Robert P.; O'Grady, Kevin

2012-01-01

The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly…

Cognitive Behavioral Treatment of PTSD in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial

ERIC Educational Resources Information Center

Johnson, Dawn M.; Zlotnick, Caron; Perez, Sara

2011-01-01

Objective: This study was designed to explore the acceptability, feasibility, and initial efficacy of a new shelter-based treatment for victims of intimate partner violence (IPV; i.e., Helping to Overcome PTSD through Empowerment [HOPE]). Method: A Phase I randomized clinical trial comparing HOPE (n = 35) with standard shelter services (SSS) (n =…

Augmented Reality M-Learning to Enhance Nursing Skills Acquisition in the Clinical Skills Laboratory

ERIC Educational Resources Information Center

Garrett, Bernard M.; Jackson, Cathryn; Wilson, Brian

2015-01-01

Purpose: This paper aims to report on a pilot research project designed to explore if new mobile augmented reality (AR) technologies have the potential to enhance the learning of clinical skills in the lab. Design/methodology/approach: An exploratory action-research-based pilot study was undertaken to explore an initial proof-of-concept design in…

Clinical Investigation Program Annual Progress Report

DTIC Science & Technology

1989-09-30

initiatives for the study of relatedness of bacterial and HLA antigens as they influence autoimmune diseases. Microbiology Service - FY 89 An in-house...1030 87/103 0 Identification of Those at Risk for Osteoporotic Hip Fractures, by an Noninvasive Measurement (P) (PR)... 105 87/104 0 SWOG 8600 - A...233 82/302 0 The Evaluation of Recently Introduced, Commercially Available Clinical Microbiology Products for Possible

Exome sequencing for the differential diagnosis of ciliary chondrodysplasias: Example of a WDR35 mutation case and review of the literature.

PubMed

Antony, Dinu; Nampoory, Narayanan; Bacchelli, Chiara; Melhem, Motasem; Wu, Kaman; James, Chela T; Beales, Philip L; Hubank, Mike; Thomas, Daisy; Mashankar, Anant; Behbehani, Kazem; Schmidts, Miriam; Alsmadi, Osama

2017-12-01

Exome sequencing is becoming widely popular and affordable, making it one of the most desirable methods for the identification of rare genetic variants for clinical diagnosis. Here, we report the clinical application of whole exome sequencing for the ultimate diagnosis of a ciliary chondrodysplasia case presented with an initial clinical diagnosis of Asphyxiating Thoracic Dystrophy (ATD, Jeune Syndrome). We have identified a novel homozygous missense mutation in WDR35 (c.206G > A), a gene previously associated with Sensenbrenner Syndrome, Ellis-van Creveld syndrome and Short-rib polydactyly syndrome type V. The genetic findings in this family led to the re-evaluation of the initial diagnosis and a differential diagnosis of Sensenbrenner Syndrome was made after cautious re-examination of the patient. Cell culture studies revealed normal subcellular localization of the mutant WDR35 protein in comparison to wildtype protein, pointing towards impaired protein-protein interaction and/or altered cell signaling pathways as a consequence of the mutated allele. This research study highlights the importance of including pathogenic variant identification in the diagnosis pipeline of ciliary chondrodysplasias, especially for clinically not fully defined phenotypes. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Defining a Bobath clinical framework - A modified e-Delphi study.

PubMed

Vaughan-Graham, Julie; Cott, Cheryl

2016-11-01

To gain consensus within the expert International Bobath Instructors Training Association (IBITA) on a Bobath clinical framework on which future efficacy studies can be based. A three-round modified e-Delphi approach was used with 204 full members of the IBITA. Twenty-one initial statements were generated from the literature. Consensus was defined a priori as at least 80% of the respondents with a level of agreement on a Likert scale of 4 or 5. The Delphi questionnaire for each round was available online for two weeks. Summary reports and subsequent questionnaires were posted within four weeks. Ninety-four IBITA members responded, forming the Delphi panel, of which 68 and 66 responded to Rounds Two and Three, respectively. The 21 initial statements were revised to 17 statements and five new statements in Round Two in which eight statements were accepted and two statements were eliminated. Round Three presented 12 revised statements, all reaching consensus. The Delphi was successful in gaining consensus on a Bobath clinical framework in a geographically diverse expert association, identifying the unique components of Bobath clinical practice. Discussion throughout all three Rounds revolved primarily around the terminology of atypical and compensatory motor behavior and balance.

Newborn screening for metabolic disorders: parental perceptions of the initial communication of results.

PubMed

Buchbinder, Mara; Timmermans, Stefan

2012-08-01

Positive newborn screening (NBS) results cause significant parental distress, but little is known about how parents find out about children's screening results and what they are told. This qualitative, exploratory study reports on parents' perceptions of the initial communication of NBS results. Participants included the parents of 75 infants referred to a metabolic clinic in California over a 3-year period (2007-2010). Parents provided information about the initial communication of NBS results during audiotaped clinical encounters and open-ended interviews. Transcripts were analyzed inductively using thematic coding. Responses fell into 3 primary themes: sources of news delivery, providing information, and mitigation strategies. The findings suggest that health care providers have access to a range of communicative resources to buffer the impact of positive screening results that may be mobilized in future interventions. Recommendations for improving the communication process and future research directions are discussed.

Use of technology for note taking and therapeutic alliance.

PubMed

Wiarda, Nicholas R; McMinn, Mark R; Peterson, Mary A; Gregor, Joel A

2014-09-01

Is psychotherapeutic alliance helped or harmed by using an iPad or computer during an intake session? Two studies are reported where psychotherapists use one of three different technologies in semistructured initial interviews: paper and pen, iPad, or a computer. The studies were conducted at a Primary Care Clinic and a Community Mental Health Clinic to provide a broader context to account for recent behavioral health integration into medical settings in addition to a traditional psychotherapy setting. The Primary Care Study consisted of 60 participants from a behavioral health service at a primary care clinic. The Community Mental Health Study involved 55 participants from a community mental health clinic in semirural Oregon. No differences were found for the three technologies in either study. Practice and training implications are offered. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Quality of clinical trials: A moving target

PubMed Central

Bhatt, Arun

2011-01-01

Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

Limb Salvage After Failed Initial Operative Management of Bimalleolar Ankle Fractures in Diabetic Neuropathy.

PubMed

Vaudreuil, Nicholas J; Fourman, Mitchell S; Wukich, Dane K

2017-03-01

Ankle fractures in patients with diabetes mellitus (DM) can be difficult to manage, especially in the presence of peripheral neuropathy. In patients who fail initial operative management, attempts at limb salvage can be challenging, and no clear treatment algorithm exists. This study examined outcomes of different procedures performed for limb salvage in this population. This study retrospectively reviewed 17 patients with DM complicated by peripheral neuropathy who sustained a bimalleolar ankle fracture and failed initial operative management. Patients were treated with revision open reduction internal fixation (ORIF) (3/17), closed reduction external fixation (CREF) (8/17), or primary ankle joint fusion (3/17 tibiotalocalcaneal fusion with hindfoot nail [TTCN] and 3/17 with tibiotalar arthrodesis using plates and screws [TTA]). Median follow-up was 20 months. The overall rate of limb salvage was 82.3% (14/17). All patients who went on to amputation presented with infection and were treated initially with CREF (3/3). All patients who achieved successful limb salvage ended up with a clinically fused ankle joint (14/14); 9 underwent a primary or delayed formal fusion and 5 had a clinically fused ankle joint at study conclusion after undergoing revision ORIF or CREF with adjunctive procedures. This small study suggests that in this complicated group of patients it is difficult to achieve limb salvage with an end result of a functional ankle joint. CREF can be a viable option in cases where underlying infection or poor bone quality is present. Treatment with revision ORIF frequently requires supplementary external fixator or tibiotalar Steinman pin placement for additional stability. All patients who underwent revision ORIF ended up with clinically fused ankle joints at the end of the study period. Primary fusion procedures (TTA, TTCN) were associated with a high rate of limb salvage and a decreased number of operations. Level III, retrospective case series.

Pre-Implementation Strategies to Adapt and Implement a Veteran Peer Coaching Intervention to Improve Mental Health Treatment Engagement Among Rural Veterans.

PubMed

Koenig, Christopher J; Abraham, Traci; Zamora, Kara A; Hill, Coleen; Kelly, P Adam; Uddo, Madeline; Hamilton, Michelle; Pyne, Jeffrey M; Seal, Karen H

2016-09-01

Telephone motivational coaching has been shown to increase urban veteran mental health treatment initiation. However, no studies have tested telephone motivational coaching delivered by veteran peers to facilitate mental health treatment initiation and engagement. This study describes pre-implementation strategies with 8 Veterans Affairs (VA) community-based outpatient clinics in the West and Mid-South United States to adapt and implement a multisite pragmatic randomized controlled trial of telephone peer motivational coaching for rural veterans. We used 2 pre-implementation strategies, Formative Evaluation (FE) research and Evidence-Based Quality Improvement (EBQI) meetings to adapt the intervention to stakeholders' needs and cultural contexts. FE data were qualitative, semi-structured interviews with rural veterans and VA clinic staff. Results were rapidly analyzed and presented to stakeholders during EBQI meetings to optimize the intervention implementation. FE research results showed that VA clinic providers felt overwhelmed by veterans' mental health needs and acknowledged limited mental health services at VA clinics. Rural veteran interviews indicated geographical, logistical, and cultural barriers to VA mental health treatment initiation and a preference for self-care to cope with mental health symptoms. EBQI meetings resulted in several intervention adaptations, including veteran study recruitment, peer veteran coach training, and an expanded definition of mental health care outcomes. As the VA moves to cultivate community partnerships in order to personalize and expand access to care for rural veterans, pre-implementation processes with engaged stakeholders, such as those described here, can help guide other researchers and clinicians to achieve proactive and veteran-centered health care services. © 2016 National Rural Health Association.

Economic evaluation of single-tooth replacement: dental implant versus fixed partial denture.

PubMed

Kim, Younhee; Park, Joo-Yeon; Park, Sun-Young; Oh, Sung-Hee; Jung, YeaJi; Kim, Ji-Min; Yoo, Soo-Yeon; Kim, Seong-Kyun

2014-01-01

This study assessed the cost-effectiveness from a societal perspective of a dental implant compared with a three-unit tooth-supported fixed partial denture (FPD) for the replacement of a single tooth in 2010. A decision tree was developed to estimate cost-effectiveness over a 10-year period. The survival rates of single-tooth implants and FPDs were extracted from a meta-analysis of single-arm studies. Medical costs included initial treatment costs, maintenance costs, and costs to treat complications. Patient surveys were used to obtain the costs of the initial single-tooth implant or FPD. Maintenance costs and costs to treat complications were based on surveys of seven clinical experts at dental clinics or hospitals. Transportation costs were calculated based on the number of visits for implant or FPD treatment. Patient time costs were estimated using the number of visits and time required, hourly wage, and employment rate. Future costs were discounted by 5% to convert to present values. The results of a 10-year period model showed that a single dental implant cost US $261 (clinic) to $342 (hospital) more than an FPD and had an average survival rate that was 10.4% higher. The incremental cost-effectiveness ratio was $2,514 in a clinic and $3,290 in a hospital for a prosthesis in situ for 10 years. The sensitivity analysis showed that initial treatment costs and survival rate influenced the cost-effectiveness. If the cost of an implant were reduced to 80% of the current cost, the implant would become the dominant intervention. Although the level of evidence for effectiveness is low, and some aspects of single-tooth implants or FPDs, such as satisfaction, were not considered, this study will help patients requiring single-tooth replacement to choose the best treatment option.

Use of email in a family practice setting: opportunities and challenges in patient- and physician-initiated communication

PubMed Central

Virji, Ayaz; Yarnall, Kimberly SH; Krause, Katrina M; Pollak, Kathryn I; Scannell, Margaret A; Gradison, Margaret; Østbye, Truls

2006-01-01

Background Electronic mail (email) has the potential to improve communication between physicians and patients. Methods We conducted two research studies in a family practice setting: 1) a brief, anonymous patient survey of a convenience sample to determine the number of clinic patients receptive to communicating with their physician via email, and 2) a randomized, controlled pilot study to assess the feasibility of providing health education via email to family practice patients. Results Sixty-eight percent of patients used email, and the majority of those (80%) were interested in using email to communicate with the clinic. The majority also reported that their email address changed less frequently than their home address (65%, n = 173) or telephone number (68%, n = 181). Forty-two percent were willing to pay an out-of-pocket fee to have email access to their physicians. When evaluating email initiated by the clinic, 26% of otherwise eligible patients could not participate because they lacked email access; those people were more likely to be black and to be insured through Medicaid. Twenty-four subjects agreed to participate, but one-third failed to return the required consent form by mail. All participants who received the intervention emails said they would like to receive health education emails in the future. Conclusion Our survey results show that patients are interested in email communication with the family practice clinic. Our feasibility study also illustrates important challenges in physician-initiated electronic communication. The 'digital divide' – decreased access to electronic technologies in lower income groups – is an ethical concern in the use of email for patient-physician communication. PMID:16911780

Experimental and clinical study of EHF treatment of vascular-vestibular dysfunction

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

Mal`tsev, A.E.; Abakarov, A.T.; Istomin, V.S.

1994-07-01

The authors present the results of a study of the effectiveness of EHF radiation on the cerebral hemodynamics, bioelectrical activity of the cerebral cortex, and functional state of the vestibular analyzer in chronic studies of cats using a model of vascular-vestibular dysfunction. The clinical part of the work reflects the results of studies of the functional state of cerebral blood circulation and the vestibular analyzer during the EHF treatment of angiovertebrogenic vestibular dysfunction in a background of initial manifestations of cerebral blood supply deficiency (angiodistonic variant).

Development of the Clinical Teaching Effectiveness Questionnaire in the United States.

PubMed

Wormley, Michelle E; Romney, Wendy; Greer, Anna E

2017-01-01

The purpose of this study was to develop a valid measure for assessing clinical teaching effectiveness within the field of physical therapy. The Clinical Teaching Effectiveness Questionnaire (CTEQ) was developed via a 4-stage process, including (1) initial content development, (2) content analysis with 8 clinical instructors with over 5 years of clinical teaching experience, (3) pilot testing with 205 clinical instructors from 2 universities in the Northeast of the United States, and (4) psychometric evaluation, including principal component analysis. The scale development process resulted in a 30-item questionnaire with 4 sections that relate to clinical teaching: learning experiences, learning environment, communication, and evaluation. The CTEQ provides a preliminary valid measure for assessing clinical teaching effectiveness in physical therapy practice.

Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study

PubMed Central

2012-01-01

Background Evidence is lacking to inform providers’ and patients’ decisions about many common treatment strategies for patients with end stage renal disease (ESRD). Methods/design The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003–2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006–2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community. Discussion The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies’ impact on clinical care and patients’ outcomes. PMID:23217181

An education and motivation intervention to change clinical management of the third stage of labor - the GIRMMAHP Initiative.

PubMed

Figueras, Albert; Narváez, Edgar; Valsecia, Mabel; Vásquez, Susana; Rojas, Germán; Camilo, Angiolina; del Valle, José-María; Aguilera, Cristina

2008-12-01

Hemorrhage and hypertensive disorders are major contributors to death after delivery in developing countries. The GIRMMAHP Initiative was designed to describe the actual delivery care in five Latin American countries and to educate and motivate clinical staff at 17 hospitals with the purpose of implementing their own clinical practice guidelines to prevent postpartum hemorrhage. A multicountry education intervention was developed in four consecutive stages, using two analyses: (a) an observational study of the clinical records in eight teaching and nine nonteaching hospitals and (b) a study of the long-term changes measured 12 months after completion of an education intervention and writing a local clinical guideline. Data from 2,247 pregnant women showed that only 23.3 percent had an active management of the third stage of labor and that 22.7 percent received no prenatal care visit. These data were used to prepare local clinical practice guidelines in each participant hospital. The proportion of active management increased to 72.6 percent of deliveries at 3 months and 58.7 percent 1 year later. Use of oxytocin during the third stage of labor increased to 85.9 percent of included deliveries. The proportion of women who had postpartum hemorrhage decreased from 12.7 percent at baseline to 5 percent at 1 year after the intervention. An education intervention and discussion of actual clinical practice problems with health professionals and their involvement in drafting clinical guidelines helped improve health care quality and practitioners' adherence to these guidelines.

Costs of Multidisciplinary Parenteral Nutrition Care Provided at a Distance via Mobile Tablets

PubMed Central

Kim, Heejung; Spaulding, Ryan; Werkowitch, Marilyn; Yadrich, Donna; Piamjariyakul, Ubolrat; Gilroy, Richard; Smith, Carol E.

2014-01-01

Background Determining the costs of healthcare delivery is a key step for providing efficient nutrition-based care. This analysis tabulates the costs of delivering home parenteral nutrition (HPN) interventions and clinical assessments through encrypted mobile technologies to increase patients’ access to healthcare providers, reduce their travel expenses, and allow early detection of infection and other complications. Methods A traditional cost-accounting method was used to tabulate all expenses related to mobile distance HPN clinic appointments, including (1) personnel time of multidisciplinary healthcare professionals, (2) supply of HPN intervention materials, and (3) equipment, connection, and delivery expenses. Results A total of 20 mobile distance clinic appointments were conducted for an average of 56 minutes each with 45 patients who required HPN infusion care. The initial setup costs included mobile tablet devices, 4G data plans, and personnel's time as well as intervention materials. The initial costs were on average $916.64 per patient, while the follow-up clinic appointments required $361.63 a month, with these costs continuing to decline as the equipment was used by multiple patients more frequently over time. Patients reported high levels of satisfaction with cost savings in travel expenses and rated the quality of care comparable to traditional in-person examinations. Conclusion This study provides important aspects of the initial cost tabulation for visual assessment for HPN appointments. These findings will be used to generate a decision algorithm for scheduling mobile distance clinic appointments intermittent with in-person visits to determine how to lower costs of nutrition assessments. To maximize the cost benefits, clinical trials must continue to collect clinical outcomes. PMID:25245253

A multidisciplinary audit of clinical coding accuracy in otolaryngology: financial, managerial and clinical governance considerations under payment-by-results.

PubMed

Nouraei, S A R; O'Hanlon, S; Butler, C R; Hadovsky, A; Donald, E; Benjamin, E; Sandhu, G S

2009-02-01

To audit the accuracy of otolaryngology clinical coding and identify ways of improving it. Prospective multidisciplinary audit, using the 'national standard clinical coding audit' methodology supplemented by 'double-reading and arbitration'. Teaching-hospital otolaryngology and clinical coding departments. Otolaryngology inpatient and day-surgery cases. Concordance between initial coding performed by a coder (first cycle) and final coding by a clinician-coder multidisciplinary team (MDT; second cycle) for primary and secondary diagnoses and procedures, and Health Resource Groupings (HRG) assignment. 1250 randomly-selected cases were studied. Coding errors occurred in 24.1% of cases (301/1250). The clinician-coder MDT reassigned 48 primary diagnoses and 186 primary procedures and identified a further 209 initially-missed secondary diagnoses and procedures. In 203 cases, patient's initial HRG changed. Incorrect coding caused an average revenue loss of 174.90 pounds per patient (14.7%) of which 60% of the total income variance was due to miscoding of a eight highly-complex head and neck cancer cases. The 'HRG drift' created the appearance of disproportionate resource utilisation when treating 'simple' cases. At our institution the total cost of maintaining a clinician-coder MDT was 4.8 times lower than the income regained through the double-reading process. This large audit of otolaryngology practice identifies a large degree of error in coding on discharge. This leads to significant loss of departmental revenue, and given that the same data is used for benchmarking and for making decisions about resource allocation, it distorts the picture of clinical practice. These can be rectified through implementing a cost-effective clinician-coder double-reading multidisciplinary team as part of a data-assurance clinical governance framework which we recommend should be established in hospitals.

Comparison of clinical signs and outcomes between dogs with presumptive ischemic myelopathy and dogs with acute noncompressive nucleus pulposus extrusion.

PubMed

Fenn, Joe; Drees, Randi; Volk, Holger A; De Decker, Steven

2016-10-01

OBJECTIVE To compare clinical signs and outcomes between dogs with presumptive ischemic myelopathy and dogs with presumptive acute noncompressive nucleus pulposus extrusion (ANNPE). DESIGN Retrospective study. ANIMALS 51 dogs with ischemic myelopathy and 42 dogs with ANNPE examined at 1 referral hospital. PROCEDURES Medical records and MRI sequences were reviewed for dogs with a presumptive antemortem diagnosis of ischemic myelopathy or ANNPE. Information regarding signalment, clinical signs at initial examination, and short-term outcome was retrospectively retrieved from patient records. Long-term outcome information was obtained by telephone communication with referring or primary-care veterinarians and owners. RESULTS Compared with the hospital population, English Staffordshire Bull Terriers and Border Collies were overrepresented in the ischemic myelopathy and ANNPE groups, respectively. Dogs with ANNPE were significantly older at disease onset and were more likely to have a history of vocalization at onset of clinical signs, have spinal hyperesthesia during initial examination, have a lesion at C1-C5 spinal cord segments, and be ambulatory at hospital discharge, compared with dogs with ischemic myelopathy. Dogs with ischemic myelopathy were more likely to have a lesion at L4-S3 spinal cord segments and have long-term fecal incontinence, compared with dogs with ANNPE. However, long-term quality of life and outcome did not differ between dogs with ischemic myelopathy and dogs with ANNPE. CONCLUSIONS AND CLINICAL RELEVANCE Results revealed differences in clinical signs at initial examination between dogs with ischemic myelopathy and dogs with ANNPE that may aid clinicians in differentiating the 2 conditions.

Recurrence of Phaeochromocytoma and Abdominal Paraganglioma After Initial Surgical Intervention.

PubMed

Johnston, Philip C; Mullan, Karen R; Atkinson, A Brew; Eatock, Fiona C; Wallace, Helen; Gray, Moyra; Hunter, Steven J

2015-05-01

Clinical and biochemical follow up after surgery for phaeochromocytoma is essential with long term studies demonstrating recurrence frequencies between 6% and 23%. To examine the characteristics and frequency of tumour recurrence in a regional endocrine referral centre, in patients with surgical resection of phaeochromocytoma (P) and abdominal paraganglioma (AP). We identified a cohort of 52 consecutive patients who attended our Regional Endocrinology & Diabetes Centre and retrospectively reviewed their clinical, biochemical and radiological data (between 2002 and 2013). After confirmation of early post-operative remission by negative biochemical testing, tumour recurrence was defined by demonstration of catecholamine excess with confirmatory imaging. Phaeochromocytoma was confirmed histologically in all cases (43:P, 9:AP, mean-age:53 years). Open adrenalectomy was performed in 20 cases and laparoscopically in 32. Hereditary phaeochromocytoma was confirmed by genetic analysis in 12 (23%) patients. Median follow up time from initial surgery was 47 months, (range: 12 - 296 months), 49 patients had no evidence of tumour recurrence at latest follow-up. Three patients (6%) demonstrated tumour development, one in a patient with VHL which occurred in a contralateral adrenal gland, one sporadic case had local recurrence, and an adrenal tumour occurred in a patient with a SDHB gene mutation who had a previous bladder tumour. After initial surgery, the tumours occurred at 8.6, 12.0 and 17.7 years respectively. In this study tumour development occurred in 6% of patients. Although tumour rates were low, careful and sustained clinical and biochemical follow up is advocated, as new tumour development or recurrence may occur long after the initial surgery is performed.

TRIAD: The Translational Research Informatics and Data Management Grid

PubMed Central

Payne, P.; Ervin, D.; Dhaval, R.; Borlawsky, T.; Lai, A.

2011-01-01

Objective Multi-disciplinary and multi-site biomedical research programs frequently require infrastructures capable of enabling the collection, management, analysis, and dissemination of heterogeneous, multi-dimensional, and distributed data and knowledge collections spanning organizational boundaries. We report on the design and initial deployment of an extensible biomedical informatics platform that is intended to address such requirements. Methods A common approach to distributed data, information, and knowledge management needs in the healthcare and life science settings is the deployment and use of a service-oriented architecture (SOA). Such SOA technologies provide for strongly-typed, semantically annotated, and stateful data and analytical services that can be combined into data and knowledge integration and analysis “pipelines.” Using this overall design pattern, we have implemented and evaluated an extensible SOA platform for clinical and translational science applications known as the Translational Research Informatics and Data-management grid (TRIAD). TRIAD is a derivative and extension of the caGrid middleware and has an emphasis on supporting agile “working interoperability” between data, information, and knowledge resources. Results Based upon initial verification and validation studies conducted in the context of a collection of driving clinical and translational research problems, we have been able to demonstrate that TRIAD achieves agile “working interoperability” between distributed data and knowledge sources. Conclusion Informed by our initial verification and validation studies, we believe TRIAD provides an example instance of a lightweight and readily adoptable approach to the use of SOA technologies in the clinical and translational research setting. Furthermore, our initial use cases illustrate the importance and efficacy of enabling “working interoperability” in heterogeneous biomedical environments. PMID:23616879

Thickened Endometrium in Postmenopausal Women With an Initial Biopsy of Limited, Benign, Surface Endometrium: Clinical Outcome and Subsequent Pathologic Diagnosis.

PubMed

Dermawan, Josephine K T; Hur, Christine; Uberti, Maria G; Flyckt, Rebecca; Falcone, Tommaso; Brainard, Jennifer; Abdul-Karim, Fadi W

2018-05-10

Endometrial biopsy or curetting is indicated for postmenopausal women with abnormal uterine bleeding and/or thickened endometrium. Often, endometrial biopsy or curetting yields limited benign surface endometrium, which may indicate insufficient sampling. This study addresses the clinical outcome and subsequent pathologic diagnoses in postmenopausal women who received this initial diagnosis. Among a total of 370 endometrial biopsy or curetting between 2012 and 2015, 192 (52%) were diagnosed as limited benign surface endometrial epithelium. The women ranged in age from 55 to 91 yr old. Their clinical presentations mainly included postmenopausal bleeding, pelvic pain, and enlarged uterus. Primarily because the initial report was interpreted as "benign," 108 (57%) had no subsequent follow-up. Interestingly, women with an increased endometrial thickness were more likely to receive repeat evaluation. Among the 84 women who underwent follow-up endometrial sampling, 6 (7%) had hyperplasia with atypia or malignancy, 21 (25%) had a repeat diagnosis of limited surface sample, 4 (5%) had insufficient materials, and 53 (63%) had other benign findings. Among the subset of women who did receive subsequent follow-up, endometrial atypia or malignancies are more likely found in those with increased body mass index. In conclusion, a slight majority of women with postmenopausal bleeding and/or thickened endometrium had an initial limited surface endometrial sample. Most had no subsequent endometrial sampling. Among those with subsequent follow-up, the majority had benign findings. The study highlights the inconsistencies in adequacy criteria for endometrial sampling and the lack of standardization of subsequent management.

TRIAD: The Translational Research Informatics and Data Management Grid.

PubMed

Payne, P; Ervin, D; Dhaval, R; Borlawsky, T; Lai, A

2011-01-01

Multi-disciplinary and multi-site biomedical research programs frequently require infrastructures capable of enabling the collection, management, analysis, and dissemination of heterogeneous, multi-dimensional, and distributed data and knowledge collections spanning organizational boundaries. We report on the design and initial deployment of an extensible biomedical informatics platform that is intended to address such requirements. A common approach to distributed data, information, and knowledge management needs in the healthcare and life science settings is the deployment and use of a service-oriented architecture (SOA). Such SOA technologies provide for strongly-typed, semantically annotated, and stateful data and analytical services that can be combined into data and knowledge integration and analysis "pipelines." Using this overall design pattern, we have implemented and evaluated an extensible SOA platform for clinical and translational science applications known as the Translational Research Informatics and Data-management grid (TRIAD). TRIAD is a derivative and extension of the caGrid middleware and has an emphasis on supporting agile "working interoperability" between data, information, and knowledge resources. Based upon initial verification and validation studies conducted in the context of a collection of driving clinical and translational research problems, we have been able to demonstrate that TRIAD achieves agile "working interoperability" between distributed data and knowledge sources. Informed by our initial verification and validation studies, we believe TRIAD provides an example instance of a lightweight and readily adoptable approach to the use of SOA technologies in the clinical and translational research setting. Furthermore, our initial use cases illustrate the importance and efficacy of enabling "working interoperability" in heterogeneous biomedical environments.

Health promotion practice and its implementation in Swedish health care.

PubMed

Brobeck, E; Odencrants, S; Bergh, H; Hildingh, C

2013-09-01

Health promotion practice is an important work assignment within the entire health and medical care sector. Nurses are important for the development and implementation of health promotion in clinical practice. The aim was to describe how district nurses view health promotion practice and how it was implemented in clinical practice following a training initiative. The study has a descriptive design and a qualitative method. The sample consisted of three focus groups with 16 participants. The interviews were conducted as a conversation with focus on the district nurses view of health promotion and its implementation in clinical practice. The data have been processed using manifest qualitative content analysis. Three categories, titled Training as motivation, Lack of grounding and Lack of scope were identified. The result demonstrated that training provides motivation, but also the importance of grounding in the organization and the need for scope in performing health promotion practice. Our results show that the training initiative has contributed positively to the district nurses' view of health promotion practice, but that they also feel that there are obstacles. The district nurses in our study suggest that health promotion practice should be more visible, and not something that is done when time permits. The district nurses feel motivated and have an enthusiasm for health promotion practice but more time and resources are required to design successful health-promoting initiatives. Before implementing a major training initiative for healthcare personnel in health promotion, it is essential to examine whether the conditions for this exist in the organization. © 2013 International Council of Nurses.

Factors associated with the initiation of disease-modifying antirheumatic drugs in newly diagnosed rheumatoid arthritis: a retrospective claims database study.

PubMed

Bonafede, Machaon M K; Fox, Kathleen M; Johnson, Barbara H; Watson, Crystal; Gandra, Shravanthi R

2012-02-01

The objectives of this study were to quantify the proportion of US patients with newly diagnosed rheumatoid arthritis (RA) in whom disease-modifying antirheumatic drug (DMARD) therapy was initiated within 12 months following diagnosis, to determine mean time to initiation, to compare the characteristics of initiators versus noninitiators, and to identify factors associated with noninitiation. A retrospective study was conducted using claims from the databases of commercial managed care and Medicare supplemental managed care to identify patients with claims containing codes for RA dated January 1, 2004, through September 30, 2008. The percentage of patients with RA and a prescription for a DMARD within 12 months after the index date (initiators) was evaluated. The characteristics of DMARD initiators and noninitiators during the preindex period were compared, including demographic and clinical characteristics, health care resource utilization, and cost variables. The probability of DMARD initiation was determined using survival analysis. Multivariate analysis was performed to estimate mean time from diagnosis to DMARD initiation based on demographic and clinical variables. Of 26,911 patients with newly diagnosed RA identified in the database searches, 63% had been prescribed a DMARD within 12 months after diagnosis. DMARD initiators were significantly more likely to have had a rheumatologist visit and rheumatoid factor testing and were more likely to have received a corticosteroid and/or an NSAID (all, P < 0.001). DMARD initiators had significantly lower total costs ($10,534 vs $12,725, respectively) and pharmacy drug costs ($2438 vs $2822) over the preindex period compared with noninitiators (both, P < 0.001). Independent factors associated with a greater likelihood of DMARD initiation included a rheumatologist visit, rheumatoid factor testing, NSAID use, and corticosteroid use. Age ≥85 years and the presence of comorbidities were associated with a significantly lower likelihood of DMARD initiation. Among managed care enrollees in the present analysis, 37% of patients newly diagnosed with RA were not being treated with DMARDs in the first 12 months after diagnosis. Time to DMARD initiation plateaued after 90 days, suggesting that if a patient was not prescribed a DMARD soon after RA diagnosis, he or she was not likely to receive one. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes.

PubMed

Lo Re, Vincent; Carbonari, Dena M; Saine, M Elle; Newcomb, Craig W; Roy, Jason A; Liu, Qing; Wu, Qufei; Cardillo, Serena; Haynes, Kevin; Kimmel, Stephen E; Reese, Peter P; Margolis, David J; Apter, Andrea J; Reddy, K Rajender; Hennessy, Sean; Bhullar, Harshvinder; Gallagher, Arlene M; Esposito, Daina B; Strom, Brian L

2017-01-01

To evaluate the risk of serious adverse events among patients with type 2 diabetes mellitus initiating saxagliptin compared with oral antidiabetic drugs (OADs) in classes other than dipeptidyl peptidase-4 (DPP-4) inhibitors. Cohort studies using 2009-2014 data from two UK medical record data sources (Clinical Practice Research Datalink, The Health Improvement Network) and two USA claims-based data sources (HealthCore Integrated Research Database, Medicare). All eligible adult patients newly prescribed saxagliptin (n=110 740) and random samples of up to 10 matched initiators of non-DPP-4 inhibitor OADs within each data source were selected (n=913 384). Outcomes were hospitalized major adverse cardiovascular events (MACE), acute kidney injury (AKI), acute liver failure (ALF), infections, and severe hypersensitivity events, evaluated using diagnostic coding algorithms and medical records. Cox regression was used to determine HRs with 95% CIs for each outcome. Meta-analyses across data sources were performed for each outcome as feasible. There were no increased incidence rates or risk of MACE, AKI, ALF, infection, or severe hypersensitivity reactions among saxagliptin initiators compared with other OAD initiators within any data source. Meta-analyses demonstrated a reduced risk of hospitalization/death from MACE (HR 0.91, 95% CI 0.85 to 0.97) and no increased risk of hospitalization for infection (HR 0.97, 95% CI 0.93 to 1.02) or AKI (HR 0.99, 95% CI 0.88 to 1.11) associated with saxagliptin initiation. ALF and hypersensitivity events were too rare to permit meta-analysis. Saxagliptin initiation was not associated with increased risk of MACE, infection, AKI, ALF, or severe hypersensitivity reactions in clinical practice settings. NCT01086280, NCT01086293, NCT01086319, NCT01086306, and NCT01377935; Results.

Clinical Improvement of Subacute and Chronic Otitis Media With Effusion Treated With Hyaluronic Acid Plus Hypertonic Solution via Nasal Lavage: A Randomized Controlled Trial.

PubMed

Cioffi, Luigi; Gallo, Patrizia; D'Avino, Antonio; Carlomagno, Francesco; Aloi, Giuseppe; D'Onofrio, Antonietta; Del Gaizo, Donatella; Giuliano, Maria; De Franchis, Raffaella; Sandomenico, Maria L; Pecoraro, Anna

2017-01-01

Background . This study, a randomized controlled trial, aims to demonstrate a clinically significant improvement in subacute and chronic otitis media with effusion through the administration of hyaluronic acid associated with hypertonic solution compared with the administration of hypertonic solution alone. The setting was an outpatient clinic of 20 primary care pediatrician offices affiliated with the 3 Local Health Units (Azienda Sanitaria Locale) of Naples. Materials and Methods . The study was conducted for 6 months, from October 2014 to the end of March 2015. The study saw the participation of 20 pediatricians who were experts in pneumatic otoscopy, each of whom enrolled 15 children. Each investigator was randomized to carry out the treatment with 3% hypertonic solution or high-molecular-weight hyaluronic acid + 3% hypertonic solution. Results . A total of 275 children were enrolled, of whom 11(equal to 4% ) were lost to follow-up. A total of 264 children completed the trial according to the protocol, 120 in the hyaluronic acid + hypertonic solution group and 144 in the hypertonic solution group. Hyaluronic acid associated with hypertonic solution and hypertonic solution alone administered by nasal lavage have proven to be safe and effective in the treatment of prolonged otitis media with effusion (initial score of -0.5, final score of 0.9, P < 001, for the hypertonic + hyaluronic acid group; initial score of -0.3, final score of 0.2, P < .001, for the hypertonic solution group). Though starting from a less favorable initial clinical score (-0.5 vs -0.3, P < .016), hyaluronic acid associated with hypertonic solution resulted in a significant increase in clinical healing (0.9 vs 0.2, P < .001). One interesting outcome was the significant reduction in the consumption of drugs (cortisone and antibiotics) during the follow-up.

Metastatic carcinoma of breast or a chordoma? A case report and clinical perspectives.

PubMed

Trivedi, Sachin; Odrazka, Karel

2015-01-01

We present a case of chordoma in a patient who had been previously treated for ductal carcinoma of the breast. The initial clinical findings and radiological studies suggested a possibility of metastases. However, the findings also adhered to the classical presentations and findings of the chordoma of the base of skull. It was only after the surgical resection and immunohistochemical confirmation that the diagnosis of chordoma could be established. Here, we discuss chordoma with the analysis of our clinical intrigue.

Clinical prediction of Gardnerella vaginalis in general practice

PubMed Central

O'Dowd, T.C.; West, R.R.

1987-01-01

In a study of 162 women with vaginal symptoms the clinical features of increased discharge, yellow discharge, 'high cheese' odour and pH greater than 5 were statistically strongly associated with the presence of Gardnerella vaginalis, confirmed by microbiological culture. The sensitivities and specificities of these clinical tests, although not as high as those of previously described sideroom tests using the amine test and microscopy for 'clue cells' nevertheless allow the clinician to predict G. vaginalis reliably and initiate treatment at first consultation. PMID:3499508

76 FR 16796 - Pediatric Anesthesia Safety Initiative (PASI)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... children. However, the planning and performance of the numerous studies needed to address the... in children. FDA seeks under PASI to encourage and facilitate scientific collaboration among multiple... clinical studies to answer unknown questions regarding the effects of anesthetics and sedatives in the...

Patient access and clinical efficiency improvement in a resident hospital-based women's medicine center clinic.

PubMed

Bush, Stephen H; Lao, Michael R; Simmons, Kathy L; Goode, Jeff H; Cunningham, Steve A; Calhoun, Byron C

2007-12-01

To apply the Six Sigma tools of Change Acceleration Process and Work-Out and to improve patient access in an outpatient clinic in a hospital-based residency training program. Observational study. Comparison of productivity in an obstetrics and gynecology clinic after implementation of the Six Sigma principles, with a comparable internal medicine clinic as a control group. Productivity from January 1 through December 31, 2005, was assessed in both clinics. After applying the Six Sigma tools to obstetrics and gynecology, outputs from both clinics from January 1 through December 31, 2006, were analyzed. Wait times for new obstetrical visits decreased from 38 to 8 days. The patient time spent in the clinic dropped from 3.2 to 1.5 hours. Initial gynecologic visits increased by 87% (from 453 to 850 per year), return gynecologic visits increased by 66% (from 1392 to 2311 per year), initial obstetrical visits increased by 55% (from 520 to 808 per year), repeat obstetrical visits increased by 45% (from 2239 to 3243 per year), and the mean patient satisfaction scores increased from 5.75 to 8.54 (on a 10-point scale). The gross clinic revenue increased by 73% in the first 6 months of 2006 over that of the previous year. By contrast, internal medicine patient wait times for new patients and for revisits, patient satisfaction scores, total number of clinic visits, and revenues remained unchanged. Application of the Six Sigma principles resulted in a team approach to solving the clinic's productivity issues.

Clinical reasoning in the real world is mediated by bounded rationality: implications for diagnostic clinical practice guidelines.

PubMed

Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-04-20

Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. FOUR MAIN THEMES WERE IDENTIFIED: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration.

Clinical Reasoning in the Real World Is Mediated by Bounded Rationality: Implications for Diagnostic Clinical Practice Guidelines

PubMed Central

Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-01-01

Background Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. Method This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. Results Four main themes were identified: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Discussion Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration. PMID:20421920

Study Suggests New Treatment Option for Some Lymphomas

Cancer.gov

Updated findings from a large European clinical trial indicate that patients with some types of lymphoma could initially be treated with the chemotherapy drug bendamustine (Treanda) and the targeted agent rituximab (Rituxan).

Autism and genetics: Clinical approach and association study with two markers of HRAS gene

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

Herault, J.; Petit, E.; Cherpi, C.

Twin studies and familial aggregation studies indicate that genetic factors could play a role in infantile autism. In an earlier study, we identified a possible positive association between autism and a c-Harvey-ras (HRAS) oncogene marker at the 3{prime} end of the coding region. In an attempt to confirm this finding, we studied a larger population, well-characterized clinically and genetically. We report a positive association between autism and two HRAS markers, the 3{prime} marker used in the initial study and an additional marker in exon 1. 46 refs., 1 fig., 2 tabs.

Psychosocial impact of prognostic genetic testing in the care of uveal melanoma patients: protocol of a controlled prospective clinical observational study.

PubMed

Erim, Yesim; Scheel, Jennifer; Breidenstein, Anja; Metz, Claudia Hd; Lohmann, Dietmar; Friederich, Hans-Christoph; Tagay, Sefik

2016-07-07

Uveal melanoma patients with a poor prognosis can be detected through genetic analysis of the tumor, which has a very high sensitivity. A large number of patients with uveal melanoma decide to receive information about their individual risk and therefore routine prognostic genetic testing is being carried out on a growing number of patients. It is obvious that a positive prediction for recidivism in the future will emotionally burden the respective patients, but research on the psychosocial impact of this innovative method is lacking. The aim of the current study is therefore to investigate the psychosocial impact (psychological distress and quality of life) of prognostic genetic testing in patients with uveal melanoma. This study is a non-randomized controlled prospective clinical observational trial. Subjects are patients with uveal melanoma, in whom genetic testing is possible. Patients who consent to genetic testing are allocated to the intervention group and patients who refuse genetic testing form the observational group. Both groups receive cancer therapy and psycho-oncological intervention when needed. The psychosocial impact of prognostic testing is investigated with the following variables: resilience, social support, fear of tumor progression, depression, general distress, cancer-specific and general health-related quality of life, attitude towards genetic testing, estimation of the perceived risk of metastasis, utilization and satisfaction with psycho-oncological crisis intervention, and sociodemographic data. Data are assessed preoperatively (at initial admission in the clinic) and postoperatively (at discharge from hospital after surgery, 6-12 weeks, 6 and 12 months after initial admission). Genetic test results are communicated 6-12 weeks after initial admission to the clinic. We created optimal conditions for investigation of the psychosocial impact of prognostic genetic testing. This study will provide information on the course of disease and psychosocial outcomes after prognostic genetic testing. We expect that empirical data from our study will give a scientific basis for medico-ethical considerations.

Idiopathic Intracranial Hypertension-A Comparison of Clinical Characteristics Between 4 Medical Centers in Different Geographic Regions of the World.

PubMed

Rosenblatt, Amir; Klein, Ainat; Roemer, Ségolène; Borruat, François-Xavier; Meira, Dália; Silva, Marta; Gökçay, Figen; Çelebisoy, Neşe; Kesler, Anat

2016-09-01

Idiopathic intracranial hypertension (IIH) is a well-characterized syndrome, most commonly affecting obese women of childbearing age. Differences in its prevalence have been reported in various populations. The aim of this article was to determine whether differences in clinical presentation and management exist for patients with IIH between different regions the world. Retrospective database analysis of adult patients with IIH from 4 different neuro-ophthalmology clinics. The data collected included gender, age of onset, body mass index (BMI), lumbar puncture opening pressure, initial visual acuity (VA), initial visual field (VF) mean deviation (MD), pharmacological or surgical treatment, length of follow-up, final VA, and final VF MD. The study population consisted of 244 patients, with significant regional variations of female to male ratio. Overall, there was no significant difference regarding the age of diagnosis or the BMI. Acetazolamide was the first line of treatment in all groups but there was a difference between countries regarding second-line treatment, including the use of surgical interventions. Mean initial VA differed between groups but the final change in VA was the same among all the study groups. There are differences in IIH presentation, treatment, and response to therapy among different countries. International prospective studies involving multiple centers are needed to determine the potential influence of environmental and genetic factors on the development of IIH and to improve the management of this potentially blinding disorder.

The harmless acute pancreatitis score: a clinical algorithm for rapid initial stratification of nonsevere disease.

PubMed

Lankisch, Paul Georg; Weber-Dany, Bettina; Hebel, Kathrin; Maisonneuve, Patrick; Lowenfels, Albert B

2009-06-01

Only severe acute pancreatitis requires treatment, according to the principles of intensive care medicine in an intensive care or intermediate care unit. The aim of the study was to define and evaluate a simple clinical algorithm for rapid initial identification of patients with a first attack of acute pancreatitis who do not require intensive care. This prospective study included 394 patients who were admitted to the Municipal Clinic of Lüneburg, Germany, between 1987 and 2003. From a number of parameters of disease severity on admission, 3 parameters that showed the strongest prediction of a nonsevere course (no rebound tenderness and/or guarding, normal hematocrit level, and normal serum creatinine level) were combined to form the harmless acute pancreatitis score (HAPS). The score then was validated in a German multicenter study including 452 patients between 2004 and 2006. In both the initial and the validation set, the HAPS correlated with a nonsevere course of the disease (P < .0001). The score correctly identified a harmless course in 200 (98%) of 204 patients. The HAPS enables identification, within approximately 30 minutes after admission, of patients with acute pancreatitis whose disease will run a mild course. The high level of accuracy of this test (98%) will allow physicians to identify patients quickly who do not require intensive care, and potentially those who will not require inpatient treatment at all. Thus, the HAPS may save substantial hospital costs.

Phenotypic changes of methicillin-resistant Staphylococcus aureus during vancomycin therapy for persistent bacteraemia and related clinical outcome.

PubMed

Kim, T; Kim, E S; Park, S Y; Sung, H; Kim, M-N; Kim, S-H; Lee, S-O; Choi, S-H; Jeong, J-Y; Woo, J H; Chong, Y P; Kim, Y S

2017-08-01

Persistent bacteraemia (PB) due to methicillin-resistant Staphylococcus aureus (MRSA) that fails to respond to glycopeptide therapy is a well-documented clinical problem. There are limited data on changes in agr functionality, vancomycin susceptibility and heteroresistance during MRSA PB. Thus, the frequency of these changes and their clinical significance remain unclear. Only patients with MRSA PB (≥7 days) from a prospective cohort of S. aureus bacteraemia were included. We collected isogenic paired strains and compared vancomycin MIC, vancomycin heteroresistance, and agr functionality between initial and final blood isolates. We also assessed the clinical outcome. A total of 49 patients had MRSA PB over 22 months. Bacteraemia persisted for a median of 13 days and most patients (98%) received glycopeptide as initial therapy. Among 49 isogenic pairs, only one pair showed a vancomycin MIC increase ≥2-fold by broth microdilution method, and only seven (14%) by E-test. Significant portions of initial isolates had vancomycin heteroresistance (49%) and agr dysfunction (76%). Development of vancomycin heteroresistance during PB occurred in four (16%) among 25 initial vancomycin-susceptible isolates, and acquisition of agr dysfunction occurred in two (16%) among 12 initial agr-functional isolates. Changes in the opposite direction occasionally occurred. These phenotypic changes during PB were not associated with mortality, whereas agr dysfunction of the initial isolates was significantly associated with mortality. During MRSA PB, phenotypic changes of MRSA isolates occurred occasionally under prolonged vancomycin exposure but were not significantly associated with clinical outcome. In contrast, initial agr dysfunction could be a predictor for mortality in MRSA PB.

Enrolling adolescents in asthma research: adolescent, parent, and physician influence in the decision-making process.

PubMed

Brody, Janet L; Annett, Robert D; Scherer, David G; Turner, Charles; Dalen, Jeanne

2009-06-01

The factors influencing family decisions to participate in adolescent asthma research are not well understood. Legal and ethical imperatives require adolescent research participation to be voluntary. While parents and adolescents often agree about research decisions, disagreements may also occur with relative frequency. Physician recommendations are also known to influence research participation decisions. Little attention has been given to how these dynamics may affect adolescents' involvement in decisions to participate in research. To examine the influence of family and physician-investigator relationships and recommendations on adolescent asthma clinical research participation decisions. A statewide community sample of 111 adolescents 11 to 17 years of age, with a diagnosis of asthma, and their parents participated in this study. Adolescents received a medical evaluation from an asthma specialist and then the family was offered participation in a hypothetical asthma clinical trial. By random assignment, the research study was presented by either the same or an unknown asthma specialist, and half the families in each group also received affirmative recommendations from the asthma specialist to participate in the hypothetical asthma clinical trial. Parents and adolescents made initial private decisions about participating in the trial. Then, following a family discussion of the clinical trial, a final research participation decision was made. Thirty-three percent of parents and adolescents initially disagreed about the research participation decision. When disagreements occurred, final decisions followed the parents' initial views except when the physician-investigator was known and a recommendation was made. Families with initial disagreement about participating were less likely to enroll when the investigator was unknown or when no recommendation was made. Adolescents who initially disagreed with parents' views were less likely to concur with the final research participation decision, felt less comfortable, and were less likely to feel they influenced the decision. Parents' views on research decisions take precedence over adolescents' views in most circumstances. Physician-investigator relationships may reduce parental resistance to participation and enhance adolescent decision-making autonomy when research participation is desired by the adolescent.

The role of serial free/total prostate-specific antigen ratios in a watchful observation protocol for men with localized prostate cancer.

PubMed

Do, V; Choo, R; De Boer, G; Klotz, L; Danjoux, C; Morton, G; Szumacher, E; Fleshner, N; Bunting, P

2002-05-01

To examine the change in the free/total prostate specific antigen ratio (f/tPSA) with time and to assess the potential value of serial measurements of f/tPSA as a determinant of disease progression in untreated, low-to-intermediate grade prostate cancer (T1b-T2b N0M0, Gleason score < or = 7 and PSA < or = 15 ng/mL). In a prospective single-arm cohort study from November 1995, patients were conservatively managed with watchful observation alone unless they met arbitrarily defined criteria (clinical, histological and biochemical) of disease progression. Patients were followed regularly and underwent blood tests including PSA and f/tPSA. The initial and mean f/tPSA and the rate of change of f/tPSA with time were evaluated against the rate constant for the PSA doubling time (PSATd). Correlation analyses were used to evaluate any association between baseline clinical variables and either the rate of change of f/tPSA or initial f/tPSA. As of December 2000, 161 of a total of 206 accrued patients had three or more f/tPSA measurements and formed the basis of the study (median age 70 years; median follow-up 2.7 years). The median initial f/tPSA was 0.16; there was a significant negative correlation between this value and the initial total PSA. The mean f/tPSA and rate of change of f/tPSA with time were significantly negatively correlated with the rate constant for PSATd. Also, the rate of change of f/tPSA correlated negatively with clinical T stage, but not with other baseline variables, including initial PSA, age and Gleason score. The f/tPSA in men with untreated, clinically localized prostate cancer varied widely. The negative correlation between the rate of change of f/tPSA with time and rate constant for PSATd suggests that both might provide valuable information to allow clinicians to develop a strategy for optimizing the timing of therapeutic intervention for those patients choosing watchful observation alone.

Enrolling adolescents in asthma research: Adolescent, parent, and physician influence in the decision-making process

PubMed Central

Brody, Janet L.; Annett, Robert D.; Scherer, David G.; Turner, Charles; Dalen, Jeanne

2009-01-01

Background The factors influencing family decisions to participate in adolescent asthma research are not well understood. Legal and ethical imperatives require adolescent research participation to be voluntary. While parents and adolescents often agree about research decisions, disagreements may also occur with relatively frequency. Physician recommendations are also known to influence research participation decisions. Little attention has been given to how these dynamics may affect adolescents’ involvement in decisions to participate in research. Objective To examine the influence of family and physician-investigator relationships and recommendations on adolescent asthma clinical research participation decisions. Methods A statewide community sample of 111 adolescents aged 11–17, with a diagnosis of asthma, and their parents participated in this study. Adolescents received a medical evaluation from an asthma specialist and then the family was offered participation in a hypothetical asthma clinical trial. By random assignment, the research study was presented by either the same or an unknown asthma specialist and half the families in each group also received affirmative recommendations from the asthma specialist to participate in the hypothetical asthma clinical trial. Parents and adolescent made initial private decisions about participating in the trial. Then, following a family discussion of the clinical trial, a final research participation decision was made. Results Thirty three percent of parents and adolescents initially disagreed about the research participation decision. When disagreements occurred, final decisions followed the parents’ initial views except when the physician-investigator was known and a recommendation was made. Families with initial disagreement about participating were less likely to enroll when the investigator was unknown or when no recommendation was made. Adolescents who initially disagreed with parents’ views were less likely to concur with the final research participation decision, felt less comfortable, and were less likely to feel they influenced the decision. Conclusions Parents’ views on research decisions take precedence over adolescents’ views in most circumstances. Physician-investigator relationships may reduce parental resistance to participation and enhance adolescent decision-making autonomy when research participation is desired by the adolescent. PMID:19544171

Initiative for Molecular Profiling and Advanced Cancer Therapy and challenges in the implementation of precision medicine.

PubMed

Tsimberidou, Apostolia-Maria

In the last decade, breakthroughs in technology have improved our understanding of genomic, transcriptional, proteomic, epigenetic aberrations and immune mechanisms in carcinogenesis. Genomics and model systems have enabled the validation of novel therapeutic strategies. Based on these developments, in 2007, we initiated the IMPACT (Initiative for Molecular Profiling and Advanced Cancer Therapy) study, the first personalized medicine program for patients with advanced cancer at The University of Texas MD Anderson Cancer Center. We demonstrated that in patients referred for Phase I clinical trials, the use of tumor molecular profiling and treatment with matched targeted therapy was associated with encouraging rates of response, progression-free survival and overall survival compared to non-matched therapy. We are currently conducting IMPACT2, a randomized study evaluating molecular profiling and targeted agents in patients with metastatic cancer. Optimization of innovative biomarker-driven clinical trials that include targeted therapy and/or immunotherapeutic approaches for carefully selected patients will accelerate the development of novel drugs and the implementation of precision medicine. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical characteristics and outcomes of fall-related open globe injuries in Japan.

PubMed

Morikawa, Shohei; Okamoto, Yoshifumi; Okamoto, Fumiki; Inomoto, Naoki; Ishikawa, Hiroto; Harimoto, Kozo; Ueda, Tetsuo; Sakamoto, Taiji; Oshika, Tetsuro

2018-07-01

To investigate the clinical characteristics and visual outcomes in patients with fall-related open globe injuries and to evaluate differences between fall-related and non-fall-related open globe injuries in Japan. A retrospective review of patients with open globe injury who presented to Japan-Clinical Research of Study (J-CREST) hospitals between 2005 and 2015 was enrolled. Clinical information including age, sex, initial visual acuity, final visual acuity, type of injury, status of the crystalline lens, zone of injury, wound length, presence of retinal detachment, proliferative vitreoretinopathy, expulsive hemorrhage, and endophthalmitis was recorded. A total of 374 eyes were enrolled, of which 120 (32.1%) suffered from fall-related injury with average age of 73.7 ± 15.9 years (range, 11-101 years). A majority of patients were female (55.8%). Of 120 patients with fall-related injury, 109 (90.8%) presented with rupture and 11 (9.2%) with laceration. A multiple regression analysis revealed that final visual acuity was significantly associated with initial visual acuity (r = 0.99, P < 0.001). Compared to non-fall-related open globe injuries, fall-related open globe injuries were associated with elderly age, female sex, poorer initial and final visual acuity, rupture, absence of the lens, larger wound size, retinal detachment, expulsive hemorrhage, and absence of endophthalmitis (P < 0.01). Fall-related open globe injuries were more frequent in elderly female and accompanied by larger wound lengths and severer ocular complications. Visual outcomes in patients with fall-related open globe injuries were related to initial visual acuity.

HbA1c Outcomes in Patients Treated With Canagliflozin Versus Sitagliptin in US Health Plans.

PubMed

Thayer, Sarah; Aguilar, Richard; Korrer, Stephanie; Chow, Wing

2017-10-01

Clinical trial evidence supports greater glycemic control with canagliflozin than with sitagliptin. The objective of this study was to provide real-world evidence comparing outcomes in routine clinical practice among patients initiating each medication. With the use of a health care administrative database, patients initiating canagliflozin were compared with patients initiating sitagliptin (first prescription fill as index date). Baseline (6 months before index date) demographic and clinical (eg, comorbidities and diabetes-related complications) characteristics were compared, and propensity score matching was used to control for baseline differences between cohorts. Outcomes included change in glycosylated hemoglobin (HbA 1c ) and persistence with medication over a 9-month period after index date. Before matching, the canagliflozin cohort (N = 3993) was younger than the sitagliptin cohort (N = 12,153) and was composed of fewer women and Medicare Advantage enrollees, with lower mean baseline comorbidity scores (all p < 0.001). Before matching, the canagliflozin cohort (valid n = 1482) had a significantly (p < 0.001) higher baseline HbA 1c (8.60) than the sitagliptin cohort (valid n = 3697; HbA 1c , 8.32). After matching (n = 1472 per cohort), patients were well balanced on baseline characteristics, and HbA 1c values were not significantly different (p = 0.634) between the cohorts. Patients initiating canagliflozin had greater reductions in HbA 1c than patients in the sitagliptin cohort (-0.93% versus -0.57%, respectively; p = 0.004), with similar mean (median) time from index date to follow-up HbA 1c of 185.4 (199.0) and 184.3 (190.5) days, respectively (p = 0.802). Only 29.8% of canagliflozin patients discontinued during follow-up compared with 41.5% of sitagliptin patients (p < 0.001); the average days of persistence on index therapy was longer for canagliflozin patients (152 days) than for sitagliptin patients (139 days; p < 0.001). In this observational study, patients initiating canagliflozin had greater reduction in HbA 1c and longer persistence with medication than did patients who initiated sitagliptin, over a 9-month period. Better understanding of antihyperglycemic treatment, HbA 1c results, and differences among patients in demographic/clinical characteristics as well as persistence with treatment will inform optimal diabetes treatment choice in routine practice. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Incidence of neuropsychiatric side effects of efavirenz in HIV-positive treatment-naïve patients in public-sector clinics in the Eastern Cape.

PubMed

Gaida, Razia; Truter, Ilse; Grobler, Christoffel

2016-01-01

It is acknowledged that almost half of patients initiated on efavirenz will experience at least one neuropsychiatric side effect. The aim was to determine the incidence and severity of neuropsychiatric side effects associated with efavirenz use in five public-sector primary healthcare clinics in the Eastern Cape. The study was a prospective drug utilisation study. A total of 126 medical records were reviewed to obtain the required information. After baseline assessment, follow-up reviews were conducted at 4 weeks, 12 weeks and 24 weeks from 2014 to 2015. The participant group was 74.60% female ( n = 94), and the average age was 37.57±10.60 years. There were no neuropsychiatric side effects recorded for any patient. After the full follow-up period, there were a total of 49 non-adherent patients and one patient had demised. A non-adherent patient was defined as a patient who did not return to the clinic for follow-up assessment and medication refills 30 days or more after the appointed date. Some patients ( n = 11) had sent a third party to the clinic to collect their antiretroviral therapy (ART). The clinic pharmacy would at times dispense a two-month supply of medication resulting in the patient presenting only every two months. Further pharmacovigilance studies need to be conducted to determine the true incidence of these side effects. Healthcare staff must be encouraged to keep complete records to ensure meaningful patient assessments. Patients being initiated on ART need to personally attend the clinic monthly for at least the first 6 months of treatment. Clinic staff should receive regular training concerning ART, including changes made to guidelines as well as reminders of side effects experienced.

Job-sharing a clinical teacher's position: an evaluation.

PubMed

Williams, S; Murphy, L

1994-01-01

The aim of this study was to evaluate the effects on staff of having two teachers share one clinical teaching position in their intensive care unit (ICU). Three, six and 12 months after the job-sharing arrangement was initiated, an 11 item questionnaire was distributed to 26 students in post-registration critical care courses, 41 clinical staff in ICU and 9 RN-managers with responsibilities for the unit. The overall response rate to the three questionnaires was 58%. All groups agreed that job-sharing was a viable alternative to full-time work. Three months after the shared position was initiated, there was uncertainty about the consistency of the teachers' performance and the adequacy of communication between them. Nine months later, there was a high level of positive responses to all areas of the teachers' performance. Most respondents felt they could approach either teacher and that more diverse ideas were generated by having two people in the teaching position.

Assessing the community clinic replacement effect on private Medicaid practices in oral health care within rural environments.

PubMed

Squillace, Joe

2013-01-01

Children in Medicaid/CHIP public coverage programs who reside in rural counties have limited access to dental care services. Shortages of dental professionals in rural areas impede utilization of dental care. Public and private initiatives are attempting to address this crisis. Missourians instituted deregulatory policies and invested in community-based initiatives. Using a Medicaid/CHIP claims administrative dataset from 2004 to 2007, this research explored patterns of utilization to assess the impact of these efforts. The number of participating private dental office providers declined over the study period, and the number of children utilizing clinics increased. Trends are being observed within the public health dental care market demonstrating clinics are replacing private dentists as providers of Medicaid/CHIP dental services. Allowing greater market entry through deregulation could provide states with greater improvements to their public dental health infrastructure. © 2012 American Association of Public Health Dentistry.

Mobile Medical Education (MoMEd) - how mobile information resources contribute to learning for undergraduate clinical students - a mixed methods study.

PubMed

Davies, Bethany S; Rafique, Jethin; Vincent, Tim R; Fairclough, Jil; Packer, Mark H; Vincent, Richard; Haq, Inam

2012-01-12

Mobile technology is increasingly being used by clinicians to access up-to-date information for patient care. These offer learning opportunities in the clinical setting for medical students but the underlying pedagogic theories are not clear. A conceptual framework is needed to understand these further. Our initial questions were how the medical students used the technology, how it enabled them to learn and what theoretical underpinning supported the learning. 387 medical students were provided with a personal digital assistant (PDA) loaded with medical resources for the duration of their clinical studies. Outcomes were assessed by a mixed-methods triangulation approach using qualitative and quantitative analysis of surveys, focus groups and usage tracking data. Learning occurred in context with timely access to key facts and through consolidation of knowledge via repetition. The PDA was an important addition to the learning ecology rather than a replacement. Contextual factors impacted on use both positively and negatively. Barriers included concerns of interrupting the clinical interaction and of negative responses from teachers and patients. Students preferred a future involving smartphone platforms. This is the first study to describe the learning ecology and pedagogic basis behind the use of mobile learning technologies in a large cohort of undergraduate medical students in the clinical environment. We have developed a model for mobile learning in the clinical setting that shows how different theories contribute to its use taking into account positive and negative contextual factors.The lessons from this study are transferable internationally, to other health care professions and to the development of similar initiatives with newer technology such as smartphones or tablet computers.

Mobile Medical Education (MoMEd) - how mobile information resources contribute to learning for undergraduate clinical students - a mixed methods study

PubMed Central

2012-01-01

Background Mobile technology is increasingly being used by clinicians to access up-to-date information for patient care. These offer learning opportunities in the clinical setting for medical students but the underlying pedagogic theories are not clear. A conceptual framework is needed to understand these further. Our initial questions were how the medical students used the technology, how it enabled them to learn and what theoretical underpinning supported the learning. Methods 387 medical students were provided with a personal digital assistant (PDA) loaded with medical resources for the duration of their clinical studies. Outcomes were assessed by a mixed-methods triangulation approach using qualitative and quantitative analysis of surveys, focus groups and usage tracking data. Results Learning occurred in context with timely access to key facts and through consolidation of knowledge via repetition. The PDA was an important addition to the learning ecology rather than a replacement. Contextual factors impacted on use both positively and negatively. Barriers included concerns of interrupting the clinical interaction and of negative responses from teachers and patients. Students preferred a future involving smartphone platforms. Conclusions This is the first study to describe the learning ecology and pedagogic basis behind the use of mobile learning technologies in a large cohort of undergraduate medical students in the clinical environment. We have developed a model for mobile learning in the clinical setting that shows how different theories contribute to its use taking into account positive and negative contextual factors. The lessons from this study are transferable internationally, to other health care professions and to the development of similar initiatives with newer technology such as smartphones or tablet computers. PMID:22240206

Design and methodology of the COACH-2 (Comparative study on guideline adherence and patient compliance in heart failure patients) study: HF clinics versus primary care in stable patients on optimal therapy.

PubMed

Luttik, M L A; Brons, M; Jaarsma, T; Hillege, H L; Hoes, A; de Jong, R; Linssen, G; Lok, D J; Berger, M; van Veldhuisen, D J

2012-08-01

Since the number of heart failure (HF) patients is still growing and long-term treatment of HF patients is necessary, it is important to initiate effective ways for structural involvement of primary care services in HF management programs. However, evidence on whether and when patients can be referred back to be managed in primary care is lacking. To determine whether long-term patient management in primary care, after initial optimisation of pharmacological and non-pharmacological treatment in a specialised HF clinic, is equally effective as long-term management in a specialised HF clinic in terms of guideline adherence and patient compliance. The study is designed as a randomised, controlled, non-inferiority trial. Two-hundred patients will be randomly assigned to be managed and followed in primary care or in a HFclinic. Patients are eligible to participate if they are (1) clinically stable, (2) optimally up-titrated on medication (according to ESC guidelines) and, (3) have received optimal education and counselling on pre-specified issues regarding HF and its treatment. Furthermore, close cooperation between secondary and primary care in terms of back referral to or consultation of the HF clinic will be provided.The primary outcome will be prescriber adherence and patient compliance with medication after 12 months. Secondary outcomes measures will be readmission rate, mortality, quality of life and patient compliance with other lifestyle changes. The results of the study will add to the understanding of the role of primary care and HF clinics in the long-term follow-up of HF patients.

A Review of Clinical Data for Currently Approved Hysteroscopic Sterilization Procedures

PubMed Central

Basinski, Cindy M

2010-01-01

Two hysteroscopic permanent sterilization procedures are approved for use in the United States: Essure® Permanent Birth Control System (Conceptus Incorporated, Mountain View, CA) and Adiana® Permanent Contraception (Hologic, Inc., Bedford, MA). This review compares the clinical trial data for these procedures. A notable difference is the resultant clinical pregnancy risk. The clinical trials for the Essure procedure have reported no pregnancies in 643 relying women in the 9 years since initiation of the studies. The clinical trial for the Adiana procedure has reported 12 pregnancies in 570 relying women in nearly 5 years of collected data. Other clinical outcome parameters concerning Essure and Adiana are examined in this review. PMID:21364861

Feasibility, safety and cost of outpatient management of acute minor ischaemic stroke: a population-based study.

PubMed

Paul, Nicola L M; Koton, Silvia; Simoni, Michela; Geraghty, Olivia C; Luengo-Fernandez, Ramon; Rothwell, Peter M

2013-03-01

Outpatient management safely and effectively prevents early recurrent stroke after transient ischaemic attack (TIA), but this approach may not be safe in patients with acute minor stroke. To study outcomes of clinic and hospital-referred patients with TIA or minor stroke (National Institute of Health Stroke Scale score ≤3) in a prospective, population-based study (Oxford Vascular Study). Of 845 patients with TIA/stroke, 587 (69%) were referred directly to outpatient clinics and 258 (31%) directly to inpatient services. Of the 250 clinic-referred minor strokes (mean age 72.7 years), 237 (95%) were investigated, treated and discharged on the same day, of whom 16 (6.8%) were subsequently admitted to hospital within 30 days for recurrent stroke (n=6), sepsis (n=3), falls (n=3), bleeding (n=2), angina (n=1) and nursing care (n=1). The 150 patients (mean age 74.8 years) with minor stroke referred directly to hospital (median length-of-stay 9 days) had a similar 30-day readmission rate (9/150; 6.3%; p=0.83) after initial discharge and a similar 30-day risk of recurrent stroke (9/237 in clinic patients vs 8/150, OR=0.70, 0.27-1.80, p=0.61). Rates of prescription of secondary prevention medication after initial clinic/hospital discharge were higher in clinic-referred than in hospital-referred patients for antiplatelets/anticoagulants (p<0.05) and lipid-lowering agents (p<0.001) and were maintained at 1-year follow-up. The mean (SD) secondary care cost was £8323 (13 133) for hospital-referred minor stroke versus £743 (1794) for clinic-referred cases. Outpatient management of clinic-referred minor stroke is feasible and may be as safe as inpatient care. Rates of early hospital admission and recurrent stroke were low and uptake and maintenance of secondary prevention was high.

The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.

PubMed

Sumi, Eriko; Teramukai, Satoshi; Yamamoto, Keiichi; Satoh, Motohiko; Yamanaka, Kenya; Yokode, Masayuki

2013-12-11

A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials.

A Multicenter Real-Life Study on the Effect of Flash Glucose Monitoring on Glycemic Control in Patients with Type 1 and Type 2 Diabetes.

PubMed

Anjana, Ranjit Mohan; Kesavadev, Jothydev; Neeta, Deshpande; Tiwaskar, Mangesh; Pradeepa, Rajendra; Jebarani, Saravanan; Thangamani, Suresh; Sastry, Nadiminty Ganapathi; Brijendra Kumar, Srivastava; Ramu, Muthu; Gupta, Pokal Prasanna Kumar; Vignesh, Jayaprakash; Chandru, Sundramoorthy; Kayalvizhi, Sengottuvel; Jagdish, Padoor Sethuraman; Uthra, Subash Chandra Bose; Lovelena, Munawar; Jyoti, Sah; Suguna Priya, Sengodan; Kannan, Alagarsamy; Mohan, Viswanathan; Unnikrishnan, Ranjit

2017-09-01

To assess the efficacy of ambulatory glucose profiling (AGP) generated by FreeStyle LibrePro ™ flash glucose monitoring (FCGM) on glycemic control in patients with uncontrolled type 1 diabetes (T1D) and type 2 diabetes (T2D). Clinical and biochemical data were obtained from 5072 patients with diabetes who had an A1c ≥7% (2536 who had been initiated on FCGM-based AGP between March 2015 and October 2016 [cases] and 2536 age-, gender-, A1c-, site- and time-matched controls who were not initiated on AGP) across seven diabetes clinics in India. Anthropometric and clinical measurements were obtained through standardized techniques. Fasting and postprandial plasma glucose and glycated hemoglobin(A1c) were estimated before and after initiation of AGP. Overall, there was a significant decrease in A1c both in cases and controls; however, the magnitude of reduction was higher among cases (1% vs.0.7%; P < 0.001).The overall reduction in A1c among cases was higher in T2D (9.2% to 8.3%) compared with T1D (9.6% to 9.4%); however, the absolute difference in A1c reduction between cases and controls was higher among T1D (0.5% vs. 0.2%) patients. The reduction in glycemic parameters was irrespective of age or gender (P for trend <0.001) across all study sites. The greatest reductions in A1c were noted within 6 months of AGP initiation. Multiple logistic regression showed that those who did not use AGP had a 1.42 higher risk (95% CI: 1.24-1.64) of not achieving even 0.1% reduction in A1c compared with those who were initiated on AGP even after adjusting for age, gender, body-mass index, systolic blood pressure, time to follow-up A1c, and medication use. This study shows that FCGM-based AGP with FreeStyle LibrePro is associated with significant reductions in A1c levels in both T1D and T2D. In addition, improvement in A1c levels was maintained across all age groups and in patients enrolled at different diabetes clinics in India.

Clinicopathological correlates in HIV seropositive tuberculosis cases presenting with jaundice after initiating antiretroviral therapy with a structured review of the literature.

PubMed

Barr, David A; Ramdial, Pravistadevi K

2012-10-14

The development of jaundice after initiation of HAART in HIV-TB co-infected patients is a challenging presentation in resource constrained settings, and is often attributed to drug induced liver injury (DILI).Some investigators have described hepatic tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) as a cause of liver disease in patients initiating HAART, which could also cause jaundice. We report the clinical and histopathological features of five HIV-TB co-infected patients presenting with a syndrome of jaundice, tender hepatomegaly, bile canalicular enzyme rise and return of constitutional symptoms within 8 weeks of initiation of highly active antiretroviral therapy (HAART) for advanced HIV infection at a rural clinic in KwaZulu Natal, South Africa.All five patients had been diagnosed with tuberculosis infection prior to HAART initiation and were on antituberculous medication at time of developing jaundice. There was evidence of multiple aetiologies of liver injury in all patients. However, based on clinical course and pathological findings, predominant hepatic injury was thought to be drug induced in one case and hepatic tuberculosis associated immune reconstitution inflammatory syndrome (TB-IRIS) in the other four.In these later 4 patients, liver biopsy findings included necrotising and non-necrotising granulomatous inflammation in the lobules and portal tracts. The granulomas demonstrated - in addition to epithelioid histiocytes and Langhans giant cells - neutrophils, plasma cells and large numbers of lymphocytes, which are not features of a conventional untreated tuberculous response. In this high TB prevalent, low resource setting, TB-IRIS may be an important cause of jaundice post-HAART initiation. Clinicopathological correlation is essential for optimal diagnosis. Further multi-organ based histopathological studies in the context of immune reconstitution would be useful to clinicians in low resource settings dealing with this challenging presentation.

Brief Report: Stigma and HIV Care Continuum Outcomes Among Ethiopian Adults Initiating ART.

PubMed

Hoffman, Susie; Tymejczyk, Olga; Kulkarni, Sarah; Lahuerta, Maria; Gadisa, Tsigereda; Remien, Robert H; Melaku, Zenebe; Nash, Denis; Elul, Batya

2017-12-01

Stigma harms the mental health of HIV-positive individuals and reduces adherence to antiretroviral therapy (ART), but less is known about stigma and other outcomes across the HIV care continuum. Among 1180 Ethiopian adults initiating ART at 6 urban HIV clinics, we examined the relationship of internalized, anticipated, and enacted stigma to HIV care-related outcomes ascertained by interview (repeat HIV-positive testing, provider vs. self-referred testing, missed clinic visit before ART initiation, eagerness to begin ART), and by abstraction of routinely collected clinical data (late ART initiation, 3-month gap in care following ART initiation). Logistic regression was used to assess the association of each type of stigma with each outcome, adjusting for potential confounders. Scoring higher on each stigma domain was associated with 50%-90% higher odds of repeat HIV-positive testing. High internalized stigma was associated with higher odds of provider vs. self-referred test [adjusted odds ratio (aOR)high vs. low: 1.7; 95% confidence interval (CI): 1.3 to 2.2]. Higher anticipated stigma was associated with lower eagerness to begin ART (aORhigh vs. low: 0.55; 0.35-0.87; aORmedium vs. low: 0.45; 95% CI: 0.30 to 0.69). Any enacted stigma was associated with higher odds of a missed visit (aORany vs. none 1.8; 1.2-2.8). Stigma was not associated with late ART-initiation or with a subsequent gap in care. These findings provide further evidence of the importance of measuring and addressing stigma across the entire care continuum. Future work should test hypotheses about specific stigma domains and outcomes in prospective intervention or observational studies.

Real-world effectiveness of osteoporosis therapies for fracture reduction in post-menopausal women.

PubMed

Yusuf, Akeem A; Cummings, Steven R; Watts, Nelson B; Feudjo, Maurille Tepie; Sprafka, J Michael; Zhou, Jincheng; Guo, Haifeng; Balasubramanian, Akhila; Cooper, Cyrus

2018-03-21

Studies examining real-world effectiveness of osteoporosis therapies are beset by limitations due to confounding by indication. By evaluating longitudinal changes in fracture incidence, we demonstrated that osteoporosis therapies are effective in reducing fracture risk in real-world practice settings. Osteoporosis therapies have been shown to reduce incidence of vertebral and non-vertebral fractures in placebo-controlled randomized clinical trials. However, information on the real-world effectiveness of these therapies is limited. We examined fracture risk reduction in older, post-menopausal women treated with osteoporosis therapies. Using Medicare claims, we identified 1,278,296 women age ≥ 65 years treated with zoledronic acid, oral bisphosphonates, denosumab, teriparatide, or raloxifene. Fracture incidence rates before and after treatment initiation were described to understand patients' fracture risk profile, and fracture reduction effectiveness of each therapy was evaluated as a longitudinal change in incidence rates. Fracture incidence rates increased during the period leading up to treatment initiation and were highest in the 3-month period most proximal to treatment initiation. Fracture incidence rates following treatment initiation were significantly lower than before treatment initiation. Compared with the 12-month pre-index period, there were reductions in clinical vertebral fractures for denosumab (45%; 95% confidence interval [CI] 39-51%), zoledronic acid (50%; 95% CI 47-52%), oral bisphosphonates (24%; 95% CI 22-26%), and teriparatide (72%; 95% CI 69-75%) during the subsequent 12 months. Relative to the first 3 months after initiation, clinical vertebral fractures were reduced for denosumab (51%; 95% CI 42-59%), zoledronic acid (25%; 95% CI 17-32%), oral bisphosphonates (23%; 95% CI 20-26%), and teriparatide (64%; 95% CI 58-69%) during the subsequent 12 months. In summary, reductions in fracture incidence over time were observed in cohorts of patients treated with osteoporosis therapies.

Can demographic, clinical and treatment-related factors available at hormonal therapy initiation predict non-persistence in women with stage I-III breast cancer?

PubMed

Cahir, Caitriona; Barron, Thomas I; Sharp, Linda; Bennett, Kathleen

2017-03-01

To investigate whether demographic, clinical and treatment-related risk factors known at treatment initiation can be used to reliably predict future hormonal therapy non-persistence in women with breast cancer, and to inform intervention development. Women with stage I-III breast cancer diagnosed 2000-2012 and prescribed hormonal therapy were identified from the National Cancer Registry Ireland (NCRI) and linked to pharmacy claims data from Ireland's Primary Care Reimbursement Services (PCRS). Non-persistence was defined as a treatment gap of ≥180 days within 5 years of initiation. Seventeen demographic, clinical and treatment-related risk factors, identified from a systematic review, were abstracted from the NCRI-PCRS dataset. Multivariate binomial models were used to estimate relative risks (RR) and risk differences (RD) for associations between risk factors and non-persistence. Calibration and discriminative performance of the models were assessed. The analysis was repeated for early non-persistence (<1 year of initiation). Within 5 years of treatment initiation 680 women (19.9%) were non-persistent. Women aged <50 years (adjusted RR 1.41, 95% CI 1.16-1.70) and those prescribed antidepressants (RR 1.22, 95% CI 1.04-1.45) had increased risk of non-persistence. Married women (RR 0.82 95% CI 0.71-0.94) and those with prior medication use (RR 0.62 95% CI 0.51-0.75) had reduced risk of non-persistence. The area under the receiver-operating characteristic (ROC) curve for non-persistence was 0.61. Findings were similar for early non-persistence. The risk prediction model did not discriminate well between women at higher and lower risk of non-persistence at treatment initiation. Future studies should consider other factors, such as psychological characteristics and experience of side-effects.

The maternal health clinic: an initiative for cardiovascular risk identification in women with pregnancy-related complications.

PubMed

Cusimano, Maria C; Pudwell, Jessica; Roddy, Michelle; Cho, Chan-Kyung Jane; Smith, Graeme N

2014-05-01

Women who develop certain common pregnancy complications have a greater chance of developing cardiovascular disease (CVD) later in life. However, most health care providers do not provide postpartum cardiovascular risk counselling or follow-up. The Maternal Health Clinic was established to address this gap in care. It targets women at increased risk of CVD to inspire lifestyle changes, encourage long-term follow-up, and initiate primary prevention. Here, we summarize results from the first 17 months of completed clinic visits. Patients experiencing at least one relevant complication in their index pregnancy were referred to the Maternal Health Clinic through standard postpartum order sheets. Patients underwent a complete assessment including screening history, physical examination, fasting bloodwork, and urinalysis. Lifetime and 30-year CVD risk estimates, along with a metabolic syndrome calculation, were determined for each patient. Complications most commonly leading to referral were gestational diabetes or impaired glucose tolerance (32.7%), preeclampsia (29.3%), preterm birth (29.3%), and gestational hypertension (19.6%). The clinic analysis group (n = 92) was compared with a healthy control group from the PreEclampsia New Emerging Team study (n = 118). Patients in the clinic analysis group had significantly increased lifetime and 30-year CVD risk estimates compared with healthy controls (P < .0001). Furthermore, 17.4% of the clinic analysis group had metabolic syndrome, compared with 6.78% of healthy controls (P < .05). This study demonstrates that the Maternal Health Clinic accurately identifies postpartum patients that have underlying cardiovascular risks which make them susceptible to CVD. The clinic may serve as an effective primary prevention strategy. Copyright © 2014 Mosby, Inc. All rights reserved.

Clinical characteristics of children with group A streptococcal toxic shock syndrome admitted to pediatric intensive care units.

PubMed

Rodríguez-Nuñez, Antonio; Dosil-Gallardo, Silvia; Jordan, Iolanda

2011-05-01

Streptococcal toxic shock syndrome (STSS) is a very rare and severe form of group A streptococcal infection whose clinical characteristics, therapy, morbidity, and mortality in children are not well known. Our objective was to describe the clinical characteristics of STSS in a series of children admitted to pediatric intensive care units (PICU). A multicenter, retrospective study of children with STSS admitted to 14 PICUs between January 1998 and December 2009 was conducted. Clinical information was obtained retrospectively by chart review. Data from 41 children were collected, 90% corresponding to the second half of the study period. Initial symptoms and signs were nonspecific. All patients developed shock and organ dysfunction, 78.0% developed coagulopathy, 70.7% neurologic dysfunction, and 68.3% respiratory failure. Rapid pharyngeal test for Streptococcus was positive in 78.0%. Initial leukocyte count was quite variable, with leukopenia present in 51.2% of patients and leukocytosis in 31.7%. Children were treated with antibiotics against group A Streptococcus (GAS), usually G penicillin or cephalosporin plus clindamycin. After a median PICU stay of 7 days (range 0-41), 65.8% of patients survived, 26.8% with sequelae. The cause of death of the 11 non-survivors was refractory shock and multi-organ failure. STSS is a very severe condition secondary to invasive GAS infection. It can occur at any age, but especially in young children. Due to the lack of specific symptoms and signs and its very rapid progression to shock and organ dysfunction, pediatricians and emergency physicians must be aware of this possibility and immediately initiate aggressive treatment when suspected.

Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.

PubMed

Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C; Dworkin, Robert H; Katz, Nathaniel P; Kehlet, Henrik; Ballantyne, Jane C; Burke, Laurie B; Carragee, Eugene; Cowan, Penney; Croll, Scott; Dionne, Raymond A; Farrar, John T; Gilron, Ian; Gordon, Debra B; Iyengar, Smriti; Jay, Gary W; Kalso, Eija A; Kerns, Robert D; McDermott, Michael P; Raja, Srinivasa N; Rappaport, Bob A; Rauschkolb, Christine; Royal, Mike A; Segerdahl, Märta; Stauffer, Joseph W; Todd, Knox H; Vanhove, Geertrui F; Wallace, Mark S; West, Christine; White, Richard E; Wu, Christopher

2016-02-01

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

Screening for Psychological Inflexibility: Initial Validation of the Avoidance and Fusion Questionnaire for Youth as a School Mental Health Screener

ERIC Educational Resources Information Center

Renshaw, Tyler L.

2017-01-01

The present study reports on the initial validation of the eight-item version of the Avoidance and Fusion Questionnaire for Youth (AFQ-Y8) as a school mental health screener for identifying clinical-level depression and anxiety caseness within a sample of urban high school students (N = 219). Results indicated that responses to the AFQ-Y8 yielded…

Do first impressions count? Frailty judged by initial clinical impression predicts medium-term mortality in vascular surgical patients.

PubMed

O'Neill, B R; Batterham, A M; Hollingsworth, A C; Durrand, J W; Danjoux, G R

2016-06-01

Recognising frailty during pre-operative assessment is important. Frail patients experience higher mortality rates and are less likely to return to baseline functional status following the physiological insult of surgery. We evaluated the association between an initial clinical impression of frailty and all-cause mortality in 392 patients attending our vascular pre-operative assessment clinic. Prevalence of frailty assessed by the initial clinical impression was 30.6% (95% CI 26.0-35.2%). There were 133 deaths in 392 patients over a median follow-up period of 4 years. Using Cox regression, adjusted for age, sex, revised cardiac risk index and surgery (yes/no), the hazard ratio for mortality for frail vs. not-frail was 2.14 (95% CI 1.51-3.05). The time to 20% mortality was 16 months in the frail group and 33 months in the not-frail group. The initial clinical impression is a useful screening tool to identify frail patients in pre-operative assessment. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

Design, development of water tank-type lung phantom and dosimetric verification in institutions participating in a phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer: Japan Clinical Oncology Group trial (JCOG0702).

PubMed

Nishio, Teiji; Shirato, Hiroki; Ishikawa, Masayori; Miyabe, Yuki; Kito, Satoshi; Narita, Yuichirou; Onimaru, Rikiya; Ishikura, Satoshi; Ito, Yoshinori; Hiraoka, Masahiro

2014-05-01

A domestic multicenter phase I study of stereotactic body radiotherapy (SBRT) for T2N0M0 non-small cell lung cancer in inoperable patients or elderly patients who refused surgery was initiated as the Japan Clinical Oncology Group trial (JCOG0702) in Japan. Prior to the clinical study, the accuracy of dose calculation in radiation treatment-planning systems was surveyed in participating institutions, and differences in the irradiating dose between the institutions were investigated. We developed a water tank-type lung phantom appropriate for verification of the exposure dose in lung SBRT. Using this water tank-type lung phantom, the dose calculated in the radiation treatment-planning system and the measured dose using a free air ionization chamber and dosimetric film were compared in a visiting survey of the seven institutions participating in the clinical study. In all participating institutions, differences between the calculated and the measured dose in the irradiation plan were as follows: the accuracy of the absolute dose in the center of the simulated tumor measured using a free air ionization chamber was within 2%, the mean gamma value was ≤ 0.47 on gamma analysis following the local dose criteria, and the pass rate was >87% for 3%/3 mm from measurement of dose distribution with dosimetric film. These findings confirmed the accuracy of delivery doses in the institutions participating in the clinical study, so that a study with integration of the institutions could be initiated.

Clinical Diagnosis of Bordetella Pertussis Infection: A Systematic Review.

PubMed

Ebell, Mark H; Marchello, Christian; Callahan, Maria

2017-01-01

Bordetella pertussis (BP) is a common cause of prolonged cough. Our objective was to perform an updated systematic review of the clinical diagnosis of BP without restriction by patient age. We identified prospective cohort studies of patients with cough or suspected pertussis and assessed study quality using QUADAS-2. We performed bivariate meta-analysis to calculate summary estimates of accuracy and created summary receiver operating characteristic curves to explore heterogeneity by vaccination status and age. Of 381 studies initially identified, 22 met our inclusion criteria, of which 14 had a low risk of bias. The overall clinical impression was the most accurate predictor of BP (positive likelihood ratio [LR+], 3.3; negative likelihood ratio [LR-], 0.63). The presence of whooping cough (LR+, 2.1) and posttussive vomiting (LR+, 1.7) somewhat increased the likelihood of BP, whereas the absence of paroxysmal cough (LR-, 0.58) and the absence of sputum (LR-, 0.63) decreased it. Whooping cough and posttussive vomiting have lower sensitivity in adults. Clinical criteria defined by the Centers for Disease Control and Prevention were sensitive (0.90) but nonspecific. Typical signs and symptoms of BP may be more sensitive but less specific in vaccinated patients. The clinician's overall impression was the most accurate way to determine the likelihood of BP infection when a patient initially presented. Clinical decision rules that combine signs, symptoms, and point-of-care tests have not yet been developed or validated. © Copyright 2017 by the American Board of Family Medicine.

AACE/ACE Disease State Clinical Review: Medical Management of Cushing Disease.

PubMed

Hamrahian, Amir H; Yuen, Kevin C J; Hoffman, Andrew R

2014-07-01

To review available medical therapies for patients with Cushing disease and to provide a roadmap for their use in clinical practice. PubMed searches were performed to identify all of the available published data on medical management of Cushing disease. Medical therapy is usually not the first-line treatment for patients with Cushing disease but may be used to improve clinical manifestations of Cushing disease in patients who are not suitable candidates for surgery, following unsuccessful surgery or recurrence, or as a "bridge therapy" in those who have undergone radiotherapy. Medical therapy may also be used in preoperative preparation of patients with severe disease. Current available medical options for patients with Cushing disease include centrally acting agents, steroidogenesis inhibitors, and a glucocorticoid receptor antagonists. At present, there are no head-to-head studies comparing the efficacy, tolerability, and safety of different U.S. Food and Drug Administration (FDA)- and non-FDA-approved drugs in patients with Cushing disease. With the initiation of new studies and the completion of ongoing clinical trials, the number of FDA-approved drugs for medical treatment of Cushing disease is expected to increase. Medical therapy has an important adjunctive role in the management of patients with Cushing disease. The decision to initiate medical treatment depends on many factors, including patient characteristics and preference. Long-term studies are needed to better define the clinical efficacy, safety, and tolerability of medical treatment of Cushing disease, including the role of combination therapies.

Clinical features, management and outcomes of progressive outer retinal necrosis (PORN) in southern Thailand.

PubMed

Sittivarakul, Wantanee; Aui-aree, Nipat

2009-03-01

To study the demographics, clinical features, treatment, and visual outcomes of progressive outer retinal necrosis (PORN) in a group of Thai patients. All cases of AIDS with a clinical diagnosis of PORN in a major tertiary referral hospital in southern Thailand between January 2003 and June 2007 were retrospectively reviewed. Demographic data, clinical features, treatment regimens, and visual outcomes were analyzed. Seven patients (11 eyes) were studied. The mean age was 44.7 years. The median CD4 count was 12 cells/mm3. A known history of cutaneous zoster was documented in 57% of cases. The median follow-up period was 17 weeks. Fifty-seven percent of the patients had bilateral disease. A majority of eyes (45.4%) had initial visual acuity of less than 20/50 to equal to or better than 20/200. About two-thirds of the eyes had anterior chamber cells. Vitritis and retinal lesions scattered throughout both posterior pole and peripheral retina were found in 72.7%. Either intravenous acyclovir in combination with intravitreal ganciclovir injections or intravenous aclyclovir alone was used for initial treatment. Retinal detachment occurred in 54.5%. Final visual acuity worsened (loss of 3 lines on the ETDRS chart or more) in 60%. Visual acuity was no light perception in 45.5% at the final recorded follow-up. Demographics, clinical features and treatment outcomes of PORN in this group of Thai patients were comparable with studies from other countries. Visual prognosis is still poor with current treatment regimens.

Tocotrienol Treatment in Familial Dysautonomia: Open-Label Pilot Study.

PubMed

Cheishvili, David; Maayan, Channa; Holzer, Naama; Tsenter, Jeanna; Lax, Elad; Petropoulos, Sophie; Razin, Aharon

2016-07-01

Familial dysautonomia (FD) is an autosomal recessive congenital neuropathy, primarily presented in Ashkenazi Jews. The most common mutation in FD patients results from a single base pair substitution of an intronic splice site in the IKBKAP gene which disrupts normal mRNA splicing and leads to tissue-specific reduction of IKBKAP protein (IKAP). To date, treatment of FD patients remains preventative, symptomatic and supportive. Based on previous in vitro evidence that tocotrienols, members of the vitamin E family, upregulate transcription of the IKBKAP gene, we aimed to investigate whether a similar effects was observed in vivo. In the current study, we assessed the effects of tocotrienol treatment on FD patients' symptoms and IKBKAP expression in white blood cells. The initial daily doses of 50 or 100 mg tocotrienol, doubled after 3 months, was administered to 32 FD patients. Twenty-eight FD patients completed the 6-month study. The first 3 months of tocotrienol treatment was associated with a significant increase in IKBKAP expression level in FD patients' blood. Despite doubling the dose after the initial 3 months of treatment, IKBKAP expression level returned to baseline by the end of the 6-month treatment. Clinical improvement was noted in the reported clinical questionnaire (with regard to dizziness, bloching, sweating, number of pneumonia, cough episodes, and walking stability), however, no significant effect was observed in any clinical measurements (weight, height, oxygen saturation, blood pressure, tear production, histamine test, vibration threshold test, nerve conduction, and heart rate variability) following Tocotrienol treatment. In conclusion, tocotrienol treatment appears significantly beneficial by clinical evaluation for some FD patients in a few clinical parameters; however it was not significant by clinical measurements. This open-label study shows the complexity of effect of tocotrienol treatment on FD patients' clinical outcomes and on IKBKAP expression level compared to in vitro results. A longitudinal study with an increased sample size is required in the future to better understand tocotrienol affect on FD patients.

True incidence and clinical significance of pneumoperitoneum after PEG placement: a prospective study.

PubMed

Wiesen, Ari J; Sideridis, Kostas; Fernandes, Angelo; Hines, Jonathan; Indaram, Anant; Weinstein, Lenny; Davidoff, Samuel; Bank, Simmy

2006-12-01

PEG is a widely used method for providing nutritional support. Although pneumoperitoneum is a known finding after PEG placement, its true incidence is subject to debate. Small retrospective studies have found varied rates of free air after PEG placement. There were a total of 65 patients. To assess the true incidence of pneumoperitoneum and its clinical significance. Prospective study. Long Island Jewish Medical Center. We obtained upright and anterior-posterior chest radiographs of 65 patients within 3 hours after PEG placement. Type of PEG tube, gauge of the needle used, number of sticks, and indications were recorded. The presence of pneumoperitoneum on the initial chest film was considered to be a positive finding. After a positive result, a repeat chest film was obtained 72 hours later to determine whether there was progression or resolution of the free air. Patients enrolled in the study were also monitored clinically for evidence of peritonitis. Of the 65 patients who underwent PEG placement, 13 developed a pneumoperitoneum on the initial chest radiograph; there was complete resolution of pneumoperitoneum at 72 hours in 10 of the 13 patients. In 3 patients, the free air persisted but was of no clinical significance. The free air was quantified by measuring the height of the air column under the diaphragm and was graded with a scoring system (0, no air; 1, small; 2, moderate; 3, large). Eleven patients who underwent PEG died during the hospitalization; none of the deaths were related to the PEG placement or pneumoperitoneum. The other 54 patients were discharged to a skilled nursing facility. No patients in the study had clinical evidence of peritonitis. There were no adverse events, ie, infection or bleeding, associated with the PEG placement in any of the patients. Our data suggest that pneumoperitoneum after PEG placement is common and, in the absence of clinical symptoms, is of no clinical significance and does not warrant any further intervention.

ED presentations of acute renal infarction.

PubMed

Huang, Chien-Cheng; Lo, Hong-Chang; Huang, Hsien-Hao; Kao, Wei-Fong; Yen, David Hung-Tsang; Wang, Lee-Min; Huang, Chun-I; Lee, Chen-Hsen

2007-02-01

The objective of the study was to investigate initial clinical characteristics that can suggest an early diagnosis of patients with acute renal infarction presenting with flank and/or abdominal pain in the emergency department (ED). From January 1, 1996, through December 31, 2005, 20 adult patients with renal infarction diagnosed by contrast-enhanced computed tomography in the ED were enrolled. Medical records, including demographic data, risk factors for thromboembolism, initial clinical presentations, laboratory data, treatment programs and outcomes, were retrospectively reviewed and analyzed. Mean patient age was 60.3 years (range, 21-80). The estimated incidence of renal infarction was 0.004% (20 of 481,540) among the ED census. The median time of onset of symptoms before the ED visit was 31 hours (range, 1-285). Eighteen patients (90%) had a history of more than 1 risk factor for thromboembolic events. In clinical presentations, all the patients had either abdominal or flank pain and tenderness. Nineteen patients (95%) had an elevated serum lactate dehydrogenase level with a mean +/- SD of 812.1 +/- 569.4 U/L. Sixteen patients (80%) presented with the triad--persisting flank or abdominal pain/tenderness, elevated serum lactate dehydrogenase level, and proteinuria. Among all 20 patients, 10 patients (50%) were diagnosed as having renal infarction at the initial ED visit. No specific clinical characteristics could be identified to distinguish those patients diagnosed early and those with delayed diagnosis. All 20 patients received medical treatment with coumadin, which was given in combination with heparin treatment in 11, peripheral intravenous and/or local intra-arterial thrombolytics with urokinase in 5, and mitral valve replacement in 1. No patient died. Although 4 patients had a mildly elevated serum creatinine level (>1.5 mg/dL) during hospitalization, none of them needs dialysis after more than 1 year of follow-up. In this study, we delineated specifically clinical features for emergency physicians to raise their suspicion index for an early diagnosis of patients with renal infarction, a disease which is uncommon and is usually delayed or missed at initial ED presentation.

Islet immunity and beta cell reserve of indigenous Black South Africans with ketoacidosis at initial diagnosis of diabetes.

PubMed

Ekpebegh, Chukwuma; Longo-Mbenza, Benjamin; Blanco-Blanco, Ernesto

2013-01-01

Islet immunity and beta cell reserve status were utilized to classify persons with ketoacidosis as the initial manifestation of diabetes. The clinical features of the various diabetes classes were also characterized. Prospective cross sectional study. Nelson Mandela Academic Hospital, Mthatha, Eastern Cape Province, South Africa. Indigenous Black South Africans with ketoacidosis as the initial manifestation of diabetes. Islet immunity and beta cell reserve were respectively assessed using serum anti-glutamic acid decarboxylase 65 (GAD) antibody and serum C-peptide after 1 mg of intravenous glucagon. Serum anti-GAD 65 antibody > or = 5 units/L and < 5 units/L, respectively defined anti-GAD 65 positive (A+) and negative (A-). Replete (beta+) and deplete (beta-) beta cell reserve were serum C-peptide after glucagon injection of > or = 0.5 ng/mL and < 0.5 ng/mL, respectively. The proportions of patients with A+beta-, A+beta+, A-beta- and A-beta+ and their clinical characteristics were determined. Of the 38 males and 33 females who participated in the study, patients were categorized in various classes: A-beta+, 46.5% (n=33/ 71); A-beta-, 26.8% (n=19/71); A+beta-, 22.5% (n=16/71); and A+beta+, 4.2% (n=3/71). The ages of the various classes were: 41.8 +/- 13.8 years for A-beta+ (n=33); 36.5 +/- 14.6 years for A-beta- (n=19); and 20.6 +/- 7.1 years for the combination of A+beta- with A+beta+ (n=19) (P<.0001, P<.0001 for the combination of A+beta- and A+beta+ vs A-beta+, P=.001 for the combination of A+beta- and A+beta+ vs A-beta-and P=.2 for A-beta- vs A-beta+. The clinical features of type 2 diabetes were most prevalent in A-beta+ class while the A+beta- and A+beta+ groups had the clinical profile of type 1A diabetes. Most of the indigenous Black South African patients with ketoacidosis as the initial manifestation of diabetes had islet immunity, beta cell reserve status and clinical profiles of type 2 diabetes.

Breast cancers with EGFR and HER2 co-amplification favor distant metastasis and poor clinical outcome

PubMed Central

Guo, Peng; Pu, Tianjie; Chen, Shinan; Qiu, Yan; Zhong, Xiaorong; Zheng, Hong; Chen, Lina; Bu, Hong; Ye, Feng

2017-01-01

ErbB signaling serves essential roles in invasive ductal carcinoma (IDC). The aim of the present study was to assess gene amplification in ErbB family members in IDC with clinical implications. Quantitative polymerase chain reaction and fluorescence in situ hybridization were performed on formalin-fixed paraffin-embedded tumor samples for gene amplification detection. The clinical and histopathological characteristics, as well as the prognostic significance, were analyzed. Among the 119 IDC patients evaluated, epidermal growth factor receptor [EGFR; also known as human epidermal growth factor receptor (HER)1], HER2, HER3 and HER4 gene amplification was observed in 30 (25.2%), 44 (36.9%), 0 (0.0%) and 1 (0.8%) patients, respectively. EGFR amplification was associated with estrogen receptor status (P=0.028) and higher possibilities of recurrence (P=0.015) and distant metastasis (following initial surgery) (P=0.011). In survival analysis, EGFR amplification was also associated with disease-free survival (DFS) (P=0.001) and overall survival (OS) (P=0.003). HER2 amplification was associated with larger tumor size (P=0.006), later clinical stage (P=0.003) and distant metastasis (following initial surgery) (P=0.006). In survival analysis, HER2 amplification was also associated with DFS (P=0.011). Notably, the present study identified a group of patients in whom EGFR and HER2 were co-amplified. This group of patients appeared to have a higher possibility of metastasis (when diagnosed) (P=0.014) and distant metastasis (following initial surgery) (P<0.001). In survival analysis, these patients were noticed to be associated with DFS (P<0.001) and OS (P=0.002). With respect to treatment regimen, this was also true for the DFS association with chemotherapy (P<0.001), radiotherapy (P<0.001) and hormonal therapy (P=0.001). The present results suggest that EGFR and HER2 amplification favor distant metastasis following initial surgery and are significantly associated with poor clinical outcome in breast cancer patients. PMID:29181099

Risk of emergent bradycardia associated with the use of carvedilol and metoprolol in routine clinical practice.

PubMed

Shin, Jaekyu; Pletcher, Mark J

2013-09-01

Large randomized trials have reported mixed results regarding the risk of bradycardia between metoprolol and carvedilol. We compared the incidence of emergent bradycardia (measured by an emergency department visit or hospitalization due to bradycardia) for patients initiating metoprolol and carvedilol. Adult beneficiaries of Medi-Cal, the State of California Medicaid program, without a diagnosis of bradycardia who initiated metoprolol or carvedilol between May 1, 2004, and November 1, 2009, were included. Cox proportional hazard regression analysis was performed to model the time to first occurrence of emergent bradycardia after initiation of the study drugs as a dependent variable and the study drug (metoprolol vs carvedilol) as the primary predictor with adjustments for total daily metoprolol-equivalent dose, formulations, and use of nonstudy drugs as time-varying covariates, as well as demographics and comorbidities. Among 38,186 subjects, 77.7% initiated metoprolol and 22.3% initiated carvedilol. The incidence of emergent bradycardia was low and comparable between the drugs (18.1 per 1000 person-years using metoprolol vs 17.7 per 100 person-years using carvedilol; unadjusted hazard ratio, 1.07; 95% confidence interval, 0.76-1.49). However, carvedilol users had substantially different population characteristics compared with metoprolol users. After adjustments for demographics, comorbidities, metoprolol-equivalent dose, formulations, and use of nonstudy drugs, initiation of metoprolol was associated with an increased risk of emergent bradycardia compared with that of carvedilol (adjusted hazard ratio, 1.64; 95% confidence interval, 1.14-2.36). Initiation of metoprolol is associated with an increased risk of emergent bradycardia compared with carvedilol, although the overall incidence of emergent bradycardia is low in routine clinical practice. Copyright © 2013 Elsevier Inc. All rights reserved.

Treating Hepatitis C in a Ryan White-Funded HIV Clinic: Has the Treatment Uptake Improved in the Interferon-Free Directly Active Antiviral Era?

PubMed

Cope, Rebecca; Glowa, Thomas; Faulds, Samantha; McMahon, Deborah; Prasad, Ramakrishna

2016-02-01

Now that highly efficacious, interferon-free (IFN-free), direct acting antivirals (DAA) for the treatment of hepatitis C (HCV) have closed the gap between treatment and cure, identifying barriers that prevent initiation of treatment is more crucial than ever. This is a retrospective study utilizing Electronic Medical Records and Prior Authorization Records to identify HCV treatment gaps, including predictors for intention-to-treat and treatment initiation in the first 15 months of a Ryan White funded human immunodeficiency virus (HIV)/HCV co-infection clinic. This study included 128 adults ≥ 18 years old with HIV and chronic HCV infection who had visited the treatment center at least once since January 2013. Provider intent-to-treat was used to differentiate patients actively considered for treatment based on documentation kept by a multidisciplinary HCV team. Members of this group who had gone on to initiate treatment were identified. Baseline characteristics were compared. Rates of active treatment consideration and treatment initiation were 30% and 14%, respectively. HCV treatment-naïve individuals were less likely to be considered for treatment [risk ratio (RR) 1.58, 95% confidence interval (CI) 1.07-2.32] and initiate therapy (RR 2.33, 95% CI 0.97-5.60). Advanced liver disease had no significant association. Black race (RR 1.96, 95% CI 0.90-4.25) and Medicaid insurance holders (RR 1.90, 95% CI 0.95-3.82) tended to be less likely to initiate therapy. The availability of IFN-free DAA regimens has yet to increase HCV treatment uptake in our HIV/HCV co-infected population. Barriers to HCV treatment initiation have shifted from medical contraindications to socioeconomic variables.

Patient-initiated Electronic Messages and Quality of Care for Patients With Diabetes and Hypertension in a Large Fee-for-Service Medical Group: Results From a Natural Experiment.

PubMed

McClellan, Sean R; Panattoni, Laura; Chan, Albert S; Tai-Seale, Ming

2016-03-01

Few studies have examined the association between patient-initiated electronic messaging (e-messaging) and clinical outcomes in fee-for-service settings. To estimate the association between patient-initiated e-messages and quality of care among patients with diabetes and hypertension. Longitudinal observational study from 2009 to 2013. In March 2011, the medical group eliminated a $60/year patient user fee for e-messaging and established a provider payment of $3-5 per patient-initiated e-message. Quality of care for patients initiating e-messages was compared before and after March 2011, relative to nonmessaging patients. Propensity score weighting accounted for differences between e-messaging and nonmessaging patients in generalized estimating equations. Large multispecialty practice in California compensating providers' fee-for-service. Patients with diabetes (N=4232) or hypertension (N=15,463) who had activated their online portal but not e-messaged before e-messaging became free. Quality of care included HEDIS-based process measures for hemoglobin (Hb) A1c, blood pressure, low-density lipoprotein (LDL), nephropathy, and retinopathy tests, and outcome measures for HbA1c, blood pressure, and LDL. E-messaging was measured as counts of patient-initiated e-message threads sent to providers. Patients were categorized into quartiles by e-messaging frequency. The probability of annually completing indicated tests increased by 1%-7% for e-messaging patients, depending on the outcome and e-messaging frequency. E-messaging was associated with small improvements in HbA1c and LDL for some patients with diabetes. Patient-initiated e-messaging may increase the likelihood of completing recommended tests, but may not be sufficient to improve clinical outcomes for most patients with diabetes or hypertension without additional interventions.

Mapping Evidence-Based Treatments for Children and Adolescents: Application of the Distillation and Matching Model to 615 Treatments from 322 Randomized Trials

ERIC Educational Resources Information Center

Chorpita, Bruce F.; Daleiden, Eric L.

2009-01-01

This study applied the distillation and matching model to 322 randomized clinical trials for child mental health treatments. The model involved initial data reduction of 615 treatment protocol descriptions by means of a set of codes describing discrete clinical strategies, referred to as practice elements. Practice elements were then summarized in…

Patient Utilization of Cognitive-Behavioral Therapy for OCD

PubMed Central

Mancebo, Maria C.; Eisen, Jane L.; Sibrava, Nicholas; Dyck, Ingrid R.; Rasmussen, Steven A.

2012-01-01

The current study examined utilization of cognitive-behavioral therapy (CBT) by individuals receiving treatment for obsessive-compulsive disorder (OCD). Participants were 202 adults with primary DSM-IV OCD who enrolled in a longitudinal, observational study of the course of OCD and completed 2 years of annual follow-up interviews using the Longitudinal Interval Follow-Up Evaluation. One hundred twenty participants reported that a mental health professional recommended CBT for their OCD symptoms at some point during the 2-year follow-up period. One quarter (n = 31) of these participants did not initiate CBT despite receiving a treatment recommendation. Thirty-one percent of the 89 participants who entered CBT endorsed dropping out of CBT prematurely and less than one third received an adequate “dose” of CBT sessions. Self-reported CBT drop-out rates were significantly greater than attrition rates reported in clinical trials using intensive schedules of exposure and ritual prevention (EX/RP). Perceived environmental barriers and fears regarding treatment participation were the most frequently endorsed reasons for not participating or dropping out of CBT. Despite its efficacy for OCD, many individuals with clinically significant symptoms fail to initiate CBT when recommended by a mental health professional, receive treatments that are less intensive than those used in clinical trials, or drop out of treatment prematurely. Financial costs of CBT, difficulty attending sessions, and fears regarding treatment are significant barriers to initiating and completing therapy. PMID:21658523

Acute-onset chronic inflammatory demyelinating polyneuropathy: An electrodiagnostic study.

PubMed

Anadani, Mohammad; Katirji, Bashar

2015-11-01

Acute-onset chronic inflammatory demyelinating polyneuropathy (A-CIDP) is an increasingly recognized CIDP subtype. Differentiating A-CIDP from Guillain-Barré syndrome (GBS) is challenging but important, because there are different treatment outcomes. We report 3 patients with A-CIDP who were initially diagnosed with severe GBS but were later confirmed to have CIDP based on their clinical course and electrodiagnostic (EDx) studies. We also report on the long-term treatment of these patients and review the literature on EDx studies in this syndrome. Three patients were initially diagnosed with GBS and responded to treatment. However, all 3 had arrest in improvement or deterioration during their rehabilitation phases. EDx studies showed prominent demyelinating changes many months after the initial presentation. All responded very well to immunotherapy. Although several features may suggest the diagnosis of A-CIDP at initial presentation, close follow-up of GBS patients during the recovery phase is also needed for accurate diagnosis. EDx studies may distinguish patients with A-CIDP from GBS patients. © 2015 Wiley Periodicals, Inc.

The value of radiographic findings for the progression of pandemic 2009 influenza A/H1N1 virus infection.

PubMed

Funaki, Takanori; Shoji, Kensuke; Yotani, Nobuyuki; Katsuta, Tomohiro; Miyazaki, Osamu; Nosaka, Shunsuke; Masaki, Hidekazu; Saitoh, Akihiko

2013-11-04

Most illnesses caused by pandemic influenza A (H1N1) pdm09 virus (A/H1N1) infection are acute and self-limiting among children. However, in some children, disease progression is rapid and may require hospitalization and transfer to a pediatric intensive care unit (PICU). We investigated factors associated with rapid disease progression among children admitted to hospital for A/H1N1 infection, particularly findings on initial chest radiographs. In this retrospective study, we investigated the records of children who had received a laboratory or clinical diagnosis of A/H1N1 infection and were admitted to the largest children's hospital in Japan between May 2009 and March 2010. The medical records were reviewed for age, underlying diseases, vital signs on admission, initial chest radiographic findings, and clinical outcomes. According to chest radiographic findings, patients were classified into 4 groups, as follows: [1] normal (n = 46), [2] hilar and/or peribronchial markings alone (n = 64), [3] consolidation (n = 64), and [4] other findings (n = 29). Factors associated with clinical outcomes were analyzed using logistic regression. Two hundreds and three patients (median 6.8 years) were enrolled in this study. Fifteen percent (31/203) of patients were admitted to PICU. Among 31 patients, 39% (12/31) of patients required mechanical ventilation (MV). When the initial chest radiographic findings were compared between patients with consolidation (n = 64) and those without consolidation (n = 139), a higher percentage of patients with consolidation were admitted to PICU (29.7% vs.8.6%, P < 0.001) and required MV (17.2% vs. 0.7%, P < 0.001). These findings remain significant when the data were analyzed with the logistic regression (P < 0.001, P < 0.001, respectively). Consolidation on initial chest radiographs was the most significant factor to predict clinical course of hospitalized children with the 2009 A/H1N1 infection.

[Alzheimer's Therapeutic Research Institute].

PubMed

Shimada, Hiroyuki; Kato, Yuichi; Fujii, Hisako; Mori, Hiroshi

2017-07-01

The Alzheimer's Therapeutic Research Institute (ATRI) was established in 2015 after ATRI director, Paul Aisen, and his fellow experts in therapeutic interventions for Alzheimer's disease (AD) moved from the Alzheimer's Disease Cooperative Study (ADCS) at the University of California to the Keck School of Medicine of the University of Southern California. The National Institute on Aging (NIA) decided to commit $14 million to the ATRI via an Alzheimer's Clinical Trials Consortium (ACTC). The ATRI supports various studies such as the Anti-Amyloid Treatment in Asymptomatic Alzheimer's study ("A4 study"), Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3), Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN), and The Alzheimer's Disease Neuroimaging Initiative-Depression Project (ADNI-D). The ATRI will share all relevant data and materials with the academic community, corporations, and government organizations. The ATRI is overseen by a Data and Safety Monitoring Board (DSMB), which comprises of leading experts in the field of Alzheimer's research and acts independently. The ATRI is slated to play a central role in clinical dementia research in the US in near future.

Mortality and loss to follow-up among HIV-infected persons on long-term antiretroviral therapy in Latin America and the Caribbean

PubMed Central

Carriquiry, Gabriela; Fink, Valeria; Koethe, John Robert; Giganti, Mark Joseph; Jayathilake, Karu; Blevins, Meridith; Cahn, Pedro; Grinsztejn, Beatriz; Wolff, Marcelo; Pape, Jean William; Padgett, Denis; Madero, Juan Sierra; Gotuzzo, Eduardo; McGowan, Catherine Carey; Shepherd, Bryan Earl

2015-01-01

Introduction Long-term survival of HIV patients after initiating highly active antiretroviral therapy (ART) has not been sufficiently described in Latin America and the Caribbean, as compared to other regions. The aim of this study was to describe the incidence of mortality, loss to follow-up (LTFU) and associated risk factors for patients enrolled in the Caribbean, Central and South America Network (CCASAnet). Methods We assessed time from ART initiation (baseline) to death or LTFU between 2000 and 2014 among ART-naïve adults (≥18 years) from sites in seven countries included in CCASAnet: Argentina, Brazil, Chile, Haiti, Honduras, Mexico and Peru. Kaplan-Meier techniques were used to estimate the probability of mortality over time. Risk factors for death were assessed using Cox regression models stratified by site and adjusted for sex, baseline age, nadir pre-ART CD4 count, calendar year of ART initiation, clinical AIDS at baseline and type of ART regimen. Results A total of 16,996 ART initiators were followed for a median of 3.5 years (interquartile range (IQR): 1.6–6.2). The median age at ART initiation was 36 years (IQR: 30–44), subjects were predominantly male (63%), median CD4 count was 156 cells/µL (IQR: 60–251) and 26% of subjects had clinical AIDS prior to starting ART. Initial ART regimens were predominantly non-nucleoside reverse transcriptase inhibitor based (86%). The cumulative incidence of LTFU five years after ART initiation was 18.2% (95% confidence interval (CI) 17.5–18.8%). A total of 1582 (9.3%) subjects died; the estimated probability of death one, three and five years after ART initiation was 5.4, 8.3 and 10.3%, respectively. The estimated five-year mortality probability varied substantially across sites, from 3.5 to 14.0%. Risk factors for death were clinical AIDS at baseline (adjusted hazard ratio (HR)=1.65 (95% CI 1.47–1.87); p<0.001), lower baseline CD4 (HR=1.95 (95% CI 1.63–2.32) for 50 vs. 350 cells/µL; p<0.001) and older age (HR=1.47 (95% CI 1.29–1.69) for 50 vs. 30 years at ART initiation; p<0.001). Conclusions In this large, long-term study of mortality among HIV-positive adults initiating ART in Latin America and the Caribbean, overall estimates of mortality were heterogeneous, generally falling between those reported in high-income countries and sub-Saharan Africa. PMID:26165322

A study of patients who go to a psychology clinic seeking treatment.

PubMed

Estupiñá, Francisco José; Labrador, Francisco Javier; García-Vera, María Paz

2012-03-01

In order to characterize a typical clinical context, as opposed to an academic or research context, this article will analyze the sociodemographic and clinical characteristics of patients who turn to a psychology clinic in need of professional help. This study was conducted using an initial sample of 1,305 patients at the Universidad Complutense de Madrid (UCM) Clínica Universitaria de Psicología. Of the sociodemographic characteristics studied, it is noteworthy that the majority of patients were women (65%) and relatively young (the average age is 29.7 years-old). The disorders for which psychological help was most often needed were anxiety and mood disorders and relationship problems, which together made up 50% of cases. In 17.70% of cases, patients had at least one comorbid disorder in addition to the one that brought them to the clinic. The generalizability and implications of the results are discussed.

Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial

PubMed Central

Tolbert, Elliott; Hannum, Susan M; Radhakrishnan, Archana; Zorn, Kelsey; Blackford, Amanda; Greco, Stephen; Smith, Karen; Snyder, Claire F

2016-01-01

Background Survivorship care plans (SCPs) are intended to facilitate communication and coordination between patients, oncologists, and primary care providers. Most SCP initiatives have focused on oncology providers initiating the SCP process, but time and resource barriers have limited uptake. Objective This trial compares the feasibility and value of 2 Web-based SCP tools: provider-initiated versus patient-initiated. Methods This mixed-methods study recruited clinicians from 2 academically-affiliated community oncology practices. Eligible patients were treated by a participating oncologist, had nonmetastatic cancer, completed acute treatment ≤ 2 months before enrollment, and had no evidence of disease. Patients were randomized 1:1 to either provider-initiated or patient-initiated SCPs—both are Web-based tools. We conducted qualitative interviews with providers at baseline and follow-up and with patients 2 months after enrollment. In addition, patients were administered the Preparing for Life as a (New) Survivor (PLANS) and Cancer Survivors’ Unmet Needs (CaSUN) surveys at baseline and 2 months. Results A total of 40 providers were approached for the study, of whom 13 (33%) enrolled. Providers or clinic staff required researcher assistance to identify eligible patients; 41 patients were randomized, of whom 25 completed follow-up (61%; 13 provider-initiated, 12 patient-initiated). Of the 25, 11 (44%) had initiated the SCP; 5 (20%) provided the SCP to their primary care provider. On the Preparing for Life as a (New) Survivor and Cancer Survivors’ Unmet Needs, patients in both arms tended to report high knowledge and confidence and few unmet needs. In qualitative interviews, providers and patients discussed SCPs’ value. Conclusions Regardless of patient- versus provider-initiated templates and the Web-based design of these tools, barriers to survivorship care planning persist. Further efforts should emphasize workflow functions for identifying and completing SCPs—regardless of the SCP form used. Trial Registration ClinicalTrials.gov NCT02405819; https://clinicaltrials.gov/ct2/show/NCT02405819 (Archived by WebCite at http://www.webcitation.org/6jWqcWOvK) PMID:28410187

The presence of nonthoracic distracting injuries does not affect the initial clinical examination of the cervical spine in evaluable blunt trauma patients: a prospective observational study.

PubMed

Konstantinidis, Agathoklis; Plurad, David; Barmparas, Galinos; Inaba, Kenji; Lam, Lydia; Bukur, Marko; Branco, Bernardino C; Demetriades, Demetrios

2011-09-01

A distracting injury mandates cervical spine (c-spine) imaging in the evaluable blunt trauma patient who demonstrates no pain or tenderness over the c-spine. The purpose of this study was to examine which distracting injuries can negatively affect the sensitivity of the standard clinical examination of the c-spine. This is a prospective observational study conducted at a Level I Trauma Center from January 1, 2008, to December 31, 2009. After institutional review board approval, all evaluable (Glasgow Coma Scale score ≥13) blunt trauma patients older than 16 years sustaining a c-spine injury were enrolled. A distracting injury was defined as any immediately evident bony or soft tissue injury or a complaint of non-c-spine pain whether or not an actual injury was subsequently diagnosed. Information regarding the initial clinical examination and the presence of a distracting injury was collected from the senior resident or attending trauma surgeon involved in the initial management. During the study period, 101 evaluable patients sustained a c-spine injury. Distracting injuries were present in 88 patients (87.1%). The most common was rib fracture (21.6%), followed by lower extremity fracture (20.5%) and upper extremity fracture (12.5%). Only four (4.0%) patients had no pain or tenderness on the initial examination of the c-spine. All four patients had bruising and tenderness to the upper anterior chest. None of these four patients developed neurologic sequelae or required a surgical stabilization or immobilization. C-spine imaging may not be required in the evaluable blunt trauma patient despite distracting injuries in any body regions that do not involve the upper chest. Further definition of distracting injuries is mandated to avoid unnecessary utilization of resources and to reduce the imaging burden associated with the evaluation of the c-spine.

Factors Associated With Nursing Students' Resilience: Communication Skills Course, Use of Social Media and Satisfaction With Clinical Placement.

PubMed

Sigalit, Warshawski; Sivia, Barnoy; Michal, Itzhaki

The purpose of this study was to explore the (a) associations between students' personal and group resilience to their utilization of social networking platforms and formally taught communication skills, (b) students' personal and clinical characteristics that are related to personal and group resilience and the perceived helpfulness of communication course, and (c) factors that contribute to students' satisfaction with their clinical placement. Data were collected from 149 second year nursing students learning in a major university in the country of Israel with the use of a self-administered structured questionnaire. Students' satisfaction from their clinical placement was measured using 1 open-ended question, analyzed through qualitative methods. Results demonstrated positive correlations between students' use of social networking to their personal and group resilience (P<.05). Moreover, social media use, religion, and clinical placement characteristics were related to resilience and to the perceived helpfulness of the communication course (P<.01). Students' satisfaction with their clinical placement was based primarily on the clinical instructors' personal and professional skills. In conclusion, social networking can and should be used as a learning tool to promote resilience among nursing students. Faculty and nurse managers should be aware of the central role of the clinical instructor and initiate collaborative and supporting initiatives. Copyright © 2016 Elsevier Inc. All rights reserved.

Scientific ways to study intercessory prayer as an intervention in clinical research.

PubMed

Rath, Linda L

2009-01-01

The purpose of this article is to share a "research journey" to study the somewhat controversial subject of Christian intercessory prayer (CIP) utilized as a clinical intervention, and the knowledge gained along the way. This article will explore the steps in the development and implementation of clinical research to scientifically examine a phenomenon that many say cannot--and should not--be studied. The sequential steps in developing this area of study are detailed and explained from the conception of the initial idea through utilization of concept analysis and literature review to develop the researchable topic. The subsequent development of both qualitative and quantitative pilot studies to investigate CIP in depth is presented to illustrate how the intervention of CIP can successfully be incorporated into clinical research. This article provides guidelines for future researchers who may want to utilize CIP as an intervention.

Study Suggests Brain Is Hard-Wired for Chronic Pain

MedlinePlus

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Early identification of ‘acute-onset’ chronic inflammatory demyelinating polyneuropathy

PubMed Central

Sung, Jia-Ying; Tani, Jowy; Park, Susanna B.; Kiernan, Matthew C.

2014-01-01

Distinguishing patients with acute-onset chronic inflammatory demyelinating polyneuropathy from acute inflammatory demyelinating polyneuropathy prior to relapse is often challenging at the onset of their clinical presentation. In the present study, nerve excitability tests were used in conjunction with the clinical phenotype and disease staging, to differentiate between patients with acute-onset chronic inflammatory demyelinating polyneuropathy and patients with acute inflammatory demyelinating polyneuropathy at an early stage, with the aim to better guide treatment. Clinical assessment, staging and nerve excitability tests were undertaken on patients initially fulfilling the diagnostic criteria of acute inflammatory demyelinating polyneuropathy soon after symptom onset and their initial presentation. Patients were subsequently followed up for minimum of 12 months to determine if their clinical presentations were more consistent with acute-onset chronic inflammatory demyelinating polyneuropathy. Clinical severity as evaluated by Medical Research Council sum score and Hughes functional grading scale were not significantly different between the two cohorts. There was no difference between the time of onset of initial symptoms and nerve excitability test assessment between the two cohorts nor were there significant differences in conventional nerve conduction study parameters. However, nerve excitability test profiles obtained from patients with acute inflammatory demyelinating polyneuropathy demonstrated abnormalities in the recovery cycle of excitability, including significantly reduced superexcitability (P < 0.001) and prolonged relative refractory period (P < 0.01), without changes in threshold electrotonus. In contrast, in patients with acute-onset chronic inflammatory demyelinating polyneuropathy, a different pattern occurred with the recovery cycle shifted downward (increased superexcitability, P < 0.05; decreased subexcitability, P < 0.05) and increased threshold change in threshold electrotonus in both hyperpolarizing and depolarizing directions [depolarizing threshold electrotonus (90–100 ms) P < 0.005, hyperpolarizing threshold electrotonus (10–20 ms), P < 0.01, hyperpolarizing threshold electrotonus (90–100 ms), P < 0.05], perhaps suggesting early hyperpolarization. In addition, using excitability parameters superexcitability, subexcitability and hyperpolarizing threshold electrotonus (10–20 ms), the patients with acute inflammatory demyelinating polyneuropathy and acute-onset chronic inflammatory demyelinating polyneuropathy could be clearly separated into two non-overlapping groups. Studies of nerve excitability may be able to differentiate acute from acute-onset chronic inflammatory demyelinating polyneuropathy at an early stage. Characteristic nerve excitability parameter changes occur in early acute-onset chronic inflammatory demyelinating polyneuropathy, to match the clinical phenotype. Importantly, this pattern of change was strikingly different to that shown by patients with acute inflammatory demyelinating polyneuropathy, suggesting that nerve excitability techniques may be useful in distinguishing acute-onset chronic inflammatory demyelinating polyneuropathy from acute inflammatory demyelinating polyneuropathy at the initial stage. PMID:24983276

Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study.

PubMed

Blasi, Francesco; Ostermann, Helmut; Racketa, Jill; Medina, Jesús; McBride, Kyle; Garau, Javier

2014-01-22

Key goals in the treatment of CAP include early response to treatment and achievement of clinical stability. The US FDA recommends early response endpoints (72 hours after initiation of treatment) in clinical trials for the treatment of community-acquired bacterial pneumonia. REACH (REtrospective Study to Assess the Clinical Management of Patients With Moderate-to-Severe Complicated Skin and Soft Tissue Infections [cSSTI] or CAP in the Hospital Setting) was a retrospective observational study, providing current data on the clinical management and resource burden of CAP in real-life settings in European hospitals. This analysis reviews the characteristics and outcomes of patients showing early positive response to treatment (time to clinical stability [TCS] ≤4 days, as assessed by Halm's criteria) compared with patients with later positive response (TCS >4 days). Patients were adults, hospitalized with CAP (2010-2011) and requiring in-hospital treatment with intravenous antibiotics. Of the 2039 patients included in REACH, 585 (28.7%) had TCS assessed by Halm's criteria: 332 (56.8%) showed early response (median 3.0 days), and 253 (43.2%) showed later response to treatment (median 7.0 days). Use of Halm's criteria varied across participating countries, ranging from 0% (Belgium) to 49.1% (UK). Patient characteristics and relevant medical history were similar between the two groups. There were no notable differences in initial antibiotic therapy between groups, except that more early responders had been treated with amoxicillin-clavulanate and amoxicillin monotherapy (22.6%; 7.5%, respectively) than later responders (5.9%; 1.2%, respectively). Initial treatment modification and re-infection or recurrences were less frequent in early responders compared with later responders (14.2% and 3.3% vs. 34.8% and 5.9%, respectively). Early responders had a shorter duration of hospitalization (mean 9.4 ± SD 7.0; median 8.0 days vs. mean 15.6 ± SD 10.5; median 12.0 days, respectively), lower rate of ICU admission (3.3% vs. 21.3%) and shorter duration of ICU stay (mean 6.2 ± SD 5.7; median 4.0 days vs. mean 10.4 ± SD 10.1; median 8.0 days, respectively) compared with later responders. Mortality was low in both groups. Achieving early clinical stabilization in CAP (≤4 days) is associated with improved outcomes, lower requirement for initial treatment modification or readmission and lower resource use, compared with a later response. NCT01293435.

Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials.

PubMed

Moler, Frank W; Silverstein, Faye S; Meert, Kathleen L; Clark, Amy E; Holubkov, Richard; Browning, Brittan; Slomine, Beth S; Christensen, James R; Dean, J Michael

2013-09-01

To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Multicenter randomized controlled trials. Pediatric intensive care and cardiac ICUs in the United States and Canada. Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Therapeutic hypothermia or therapeutic normothermia. From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.

Clinical and Demographic Characteristics Related to Onset

PubMed Central

Norris, Scott A; Jinnah, H A; Espay, Alberto J.; Klein, Christine; Brüggemann, Norbert; Barbano, Richard L.; Malaty, Irene; Rodriguez, Ramon L.; Vidailhet, Marie; Roze, Emmanuel; Reich, Stephen G.; Berman, Brian D.; LeDoux, Mark S.; Richardson, Sarah Pirio; Agarwal, Pinky; Mari, Zoltan; Ondo, William; Shih, Ludy C; Fox, Susan; Berardelli, Alfredo; Testa, Claudia M; Chang, Florence CF; Troung, Daniel; Nahab, Fatta; Xie, Tao; Hallett, Mark; Rosen, Ami R; Wright, Laura J; Perlmutter, JS

2016-01-01

Background Clinical characteristics of isolated, idiopathic cervical dystonia such as onset site and spread to and from additional body regions have been addressed in single-site studies with limited data and incomplete or variable dissociation of focal and segmental subtypes. Objectives To characterize clinical characteristics and demographics of isolated, idiopathic cervical dystonia in the largest standardized, multicenter cohort. Methods The Dystonia Coalition, through a consortium of 37 recruiting sites in North America, Europe and Australia recruited 1477 participants with focal (60.7%) or segmental (39.3%) cervical dystonia on examination. Clinical and demographic characteristics were evaluated in terms of the body region of dystonia onset and spread. Results Site of dystonia onset was: a) focal neck only (78.5%), b) focal onset elsewhere with later segmental spread to neck (13.3%), and c) segmental onset with initial neck involvement (8.2%).Frequency of spread from focal cervical to segmental dystonia (22.8%) was consistent with prior reports, but frequency of segmental onset with initial neck involvement was substantially higher than 3% previously reported. Cervical dystonia with focal neck onset, more than other subtypes, is associated with spread and tremor of any type. Sensory tricks were less frequent in cervical dystonia with segmental components, and segmental cervical onset occurred at an older age. Conclusions Subgroups had modest but significant differences in the clinical characteristics that may represent different clinical entities or pathophysiologic subtypes. These findings are critical for design and implementation of studies to describe, treat, or modify disease progression in idiopathic isolated cervical dystonia. PMID:27753188

The effect of telemedicine on cognitive decline in patients with dementia.

PubMed

Kim, Heeseok; Jhoo, Jin Hyeong; Jang, Jae-Won

2017-01-01

Introduction Telemedicine has the advantage of providing medical resources in rural areas, but few studies have been conducted to investigate its efficacy in dementia care, compared to face-to-face care. This study evaluated the effectiveness of telemedicine in relation to cognitive changes in patients with dementia. Methods We evaluated cognitive changes over time, according to care modality, in 188 patients with dementia who were registered at our university-based dementia clinic. We followed 98 patients using telemedicine services and 90 patients who attended the dementia clinic in person. Patients in the telemedicine group also visited a public health center located in a rural area about 50 km from the dementia clinic. Results Changes in the mean annualized Mini-Mental State Examination (MMSE) score were not significantly different between the telemedicine group and the face-to-face dementia clinic group ( p = 0.291), with changes of 0.60 and 1.03 points, respectively. However, cognitive decline was significantly lower in the telemedicine group for the less severe initial cognitive performance subgroup than more severe cognitive performance subgroup ( p = 0.049), with changes of 0.62 and 1.59 points, respectively. Higher initial Clinical Dementia Rating (CDR) scores, MMSE scores, and age were found to be independent predictive factors of subsequent cognitive changes, as indicated by mean annualized MMSE scores. Discussion These findings suggest that telemedicine may be a useful alternative to face-to-face clinical visits for management of dementia in patients who are located in rural areas.

Leigh Syndrome in Childhood: Neurologic Progression and Functional Outcome.

PubMed

Lee, Jin Sook; Kim, Hunmin; Lim, Byung Chan; Hwang, Hee; Choi, Jieun; Kim, Ki Joong; Hwang, Yong Seung; Chae, Jong Hee

2016-04-01

Few studies have analyzed the clinical course and functional outcome in Leigh syndrome (LS). The aim of this study was to determine the clinical, radiological, biochemical, and genetic features of patients with LS, and identify prognostic indicators of the disease progression and neurological outcome. Thirty-nine patients who had been diagnosed with LS at the Seoul National University Children's Hospital were included. Their medical records, neuroimaging findings, and histological/biochemical findings of skeletal muscle specimens were reviewed. Targeted sequencing of mitochondrial DNA was performed based on mitochondrial respiratory chain (MRC) enzyme defects. Isolated complex I deficiency was the most frequently observed MRC defect (in 42% of 38 investigated patients). Mitochondrial DNA mutations were identified in 11 patients, of which 81.8% were MT-ND genes. The clinical outcome varied widely, from independent daily activity to severe disability. Poor functional outcomes and neurological deterioration were significantly associated with early onset (before an age of 1 year) and the presence of other lesions additional to basal ganglia involvement in the initial neuroimaging. The neurological severity and outcome of LS may vary widely and be better than those predicted based on previous studies. We suggest that age at onset and initial neuroimaging findings are prognostic indicators in LS.

Clinical presentation and outcome of dogs treated medically or surgically for thoracolumbar intervertebral disc protrusion.

PubMed

Crawford, A H; De Decker, S

2017-06-10

To date, few studies have investigated the clinical characteristics of thoracolumbar intervertebral disc protrusion (IVDP). The aim of this retrospective study was to evaluate the presentation and outcome of dogs receiving medical or surgical treatment for thoracolumbar IVDP. Eighty-four dogs were included, with a median age of 9.4 years. German shepherd dogs and Staffordshire bull terriers were the most common breeds. Significantly more surgically treated dogs (n=53) had neurological deficits and were non-ambulatory, compared with medically treated (n=31). Outcome data were available for 27 of 31 medically managed dogs; 11 initially improved, 7 remained stable and 9 deteriorated. Of 18 dogs that initially improved or stabilised, 10 (55.6 per cent) demonstrated recurrence of clinical signs within 12 months of diagnosis. Outcome data were available for 45 of 50 surgically treated dogs that survived to hospital discharge; 34 improved, 9 remained stable and 2 deteriorated following surgery. Of 43 dogs that improved or stabilised with surgical treatment, 11 (25.6 per cent) demonstrated recurrence of clinical signs within 12 months of surgery. Overall, significantly more surgically treated dogs (71.1 per cent) had a successful outcome, consisting of sustained clinical improvement of more than 12 months duration, compared with medically treated dogs (29.6 per cent). British Veterinary Association.

Increased incidence of clinical hypotension with etomidate compared to ketamine for intubation in septic patients: A propensity matched analysis.

PubMed

Van Berkel, Megan A; Exline, Matthew C; Cape, Kari M; Ryder, Lindsay P; Phillips, Gary; Ali, Naeem A; Doepker, Bruce A

2017-04-01

This study compared the incidence of clinical hypotension between ketamine and etomidate within a 24 hour period following endotracheal intubation. This single-center, retrospective propensity-matched cohort study included septic patients admitted to our medical intensive care unit who received either etomidate or ketamine for intubation. Clinical hypotension was defined as any one of the following: mean arterial pressure (MAP) decrease >40% compared to baseline and MAP <70 mmHg, MAP <60 mmHg, initiation of a vasopressor, or increase to >30% of the initial vasopressor dose. Patients were matched based on propensity scores determined by demographics and baseline characteristics. A total of 384 (200 etomidate and 184 ketamine) patients were included for analysis with 230 patients (115 in each group) matched. Clinical hypotension was less prevalent in patients who received ketamine as compared to etomidate [51.3% vs. 73% (odds ratio=0.39, 95% confidence interval=0.22-0.67, P=.001]. The etomidate group experienced significantly lower MAPs at time periods 6.1-12 hours (65.1 mmHg vs. 69.3 mmHg, P=.01) and 12.1-24 hours (63.9 mmHg vs. 68.4 mmHg, P=.003). Ketamine was associated with a lower incidence of clinical hypotension within the 24 hour period following endotracheal intubation in septic patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Olfactory Hallucinations without Clinical Motor Activity: A Comparison of Unirhinal with Birhinal Phantosmia

PubMed Central

Henkin, Robert I.; Potolicchio, Samuel J.; Levy, Lucien M.

2013-01-01

Olfactory hallucinations without subsequent myoclonic activity have not been well characterized or understood. Herein we describe, in a retrospective study, two major forms of olfactory hallucinations labeled phantosmias: one, unirhinal, the other, birhinal. To describe these disorders we performed several procedures to elucidate similarities and differences between these processes. From 1272, patients evaluated for taste and smell dysfunction at The Taste and Smell Clinic, Washington, DC with clinical history, neurological and otolaryngological examinations, evaluations of taste and smell function, EEG and neuroradiological studies 40 exhibited cyclic unirhinal phantosmia (CUP) usually without hyposmia whereas 88 exhibited non-cyclic birhinal phantosmia with associated symptomology (BPAS) with hyposmia. Patients with CUP developed phantosmia spontaneously or after laughing, coughing or shouting initially with spontaneous inhibition and subsequently with Valsalva maneuvers, sleep or nasal water inhalation; they had frequent EEG changes usually ipsilateral sharp waves. Patients with BPAS developed phantosmia secondary to several clinical events usually after hyposmia onset with few EEG changes; their phantosmia could not be initiated or inhibited by any physiological maneuver. CUP is uncommonly encountered and represents a newly defined clinical syndrome. BPAS is commonly encountered, has been observed previously but has not been clearly defined. Mechanisms responsible for phantosmia in each group were related to decreased gamma-aminobutyric acid (GABA) activity in specific brain regions. Treatment which activated brain GABA inhibited phantosmia in both groups. PMID:24961619

Rheumatoid arthritis phenotype at presentation differs depending on the number of autoantibodies present.

PubMed

Derksen, V F A M; Ajeganova, S; Trouw, L A; van der Helm-van Mil, A H M; Hafström, I; Huizinga, T W J; Toes, R E M; Svensson, B; van der Woude, D

2017-04-01

In rheumatoid arthritis (RA), seropositive and seronegative disease may be two entities with different underlying pathophysiological mechanisms, long-term outcomes and disease presentations. However, the effect of the conjoint presence of multiple autoantibodies, as proxy for a more pronounced humoral autoimmune response, on clinical phenotype remains unclear. Therefore, this study investigates the association between the number of autoantibodies and initial clinical presentation in two independent cohorts of patients with early RA. Autoantibody status (rheumatoid factor, anticitrullinated protein antibodies and anticarbamylated protein antibodies) was determined at baseline in the Leiden Early Arthritis Cohort (n=828) and the Swedish BARFOT (Better Anti-Rheumatic Farmaco-Therapy, n=802) study. The association between the number of autoantibodies and baseline clinical characteristics was investigated using univariable and multivariable ordinal regression. In both cohorts, the following independent associations were found in multivariable analysis: patients with a higher number of RA-associated antibodies were younger, more often smokers, had a longer symptom duration and a higher erythrocyte sedimentation rate at presentation compared with patients with few autoantibodies. The number of autoantibodies, reflecting the breadth of the humoral autoimmune response, is associated with the clinical presentation of RA. Predisease pathophysiology is thus reflected by the initial clinical phenotype. 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/.

Cross-border reproductive care in North America: a pilot study testing a prospective data collection program for in vitro fertilization clinics in Canada and the United States.

PubMed

Hughes, Edward G; Sawyer, Angie; DeJean, Deirdre; Adamson, G David

2016-03-01

To develop and test a nonidentifying prospective data collection system for cross-border reproductive care (CBRC) in Canada and the United States (U.S.). Survey and cross-sectional study. Fertility clinics. Women traveling to and from Canada and the U.S. for reproductive care. None. Patients' home country, reason for crossing borders, and type of care received. Of 32 Canadian and 440 U.S. clinics contacted, seven and 46, respectively, responded to the initial questionnaire. Three out of seven Canadian and 44 out of 46 U.S. clinics reported providing CBRC. Seventy five percent agreed that nonidentifying data on country of origin and reason for travel should be collected. However, only one of seven Canadian and none of 46 U.S. clinics that expressed initial interest actually collected data, despite multiple communications. Although CBRC is a major component of assisted reproductive technology in North America (3%-10% of IVF cycles are provided to out-of-country patients in Canada and the U.S.), clinicians are not motivated to collect the simplest of data regarding CBRC patients. Despite this, reliable data are needed to help better understand the reasons for and impact of CBRC. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

[Fever and petechial exanthema in children].

PubMed

Soult Rubio, J A; Navarro González, J; Olano Claret, P

1992-11-01

In an attempt to determine clinical and analytical predictive parameters of a possible grave disease, we have carried out a retrospective study of 172 children admitted to our hospital with fever and petechiae as initial symptoms. The ages ranged between 1 month and 10 years. Even though we have not found a clinical symptom or analysis sufficiently sensitive as to predict all grave diseases, the general clinical state of the child associated with either a high or low white cell count and an abnormal coagulation study should be alert signals for a serious infectious disease. On the contrary, if the clinical and analytical parameters are within normal limits the risk of a grave disease is low. We emphasize the high incidence of meningococcal disease (26%).

Malformations of cortical development: clinical spectrum in a series of 101 patients and review of the literature (Part I).

PubMed

Güngör, Serdal; Yalnizoğlu, Dilek; Turanli, Güzide; Saatçi, Işil; Erdoğan-Bakar, Emel; Topçu, Meral

2007-01-01

Patients with malformations of cortical development (MCD) present with a wide spectrum of clinical manifestations ranging from asymptomatic cases to those with epilepsy and neurodevelopmental problems. Thorough clinical delineation of patients with MCD may provide clues for future phenotype-genotype correlation studies. We studied clinical features of patients with MCD, including developmental risk factors and family history. We evaluated 10 patients with MCD at Hacettepe University Children's Hospital, Department of Pediatric Neurology. All patients underwent neurological evaluation with detailed medical and family history, and neuropsychological evaluation. Routine EEG and MRI were obtained. The patients were between 1 month and 19 years of age (mean: 6.1 +/- 4.4 years). Fifty-four patients were diagnosed with polymicrogyria (PMG), 23 patients with lissencephaly, 12 patients with schizencephaly, and 12 patients with heterotopia. Parents were relatives in 31.7% of the cases; consanguinity was most common in patients with lissencephaly and other MCDs with diffuse/bilateral involvement. Initial clinical presentation was seizures in 61.4% of the cases, developmental delays in 12.9%, and microcephaly in 9.9%. Neurological evaluation revealed most severe abnormalities in patients with lissencephaly, and relatively better outcome in patients with heterotopias. Cognitive functions were better in patients with heterotopias compared to other groups. Overall, 71.3% of patients ha epilepsy. In conclusion, initial presentation and clinical course of patients with MCD are variable and seem to be correlated with the extent of cortical involvement. Epilepsy and mental retardation are the most common problems. The most severe clinical outcome was seen in patients with lissencephaly.

Research on curcumin: A meta-analysis of potentially malignant disorders.

PubMed

Ara, Syeda Arshiya; Mudda, Jayashree A; Lingappa, Ashok; Rao, Purushottam

2016-01-01

Turmeric has been described in ayurveda, and is referred by different names in different cultures, the active principle called curcumin or diferuloylmethane, has been shown to exhibit numerous activities. Extensive research over the last half century has revealed several important functions of curcumin. It binds to a variety of proteins and inhibits the activity of various kinases. By modulating the activation of various transcription factors, curcumin regulates the expression of inflammatory enzymes, cytokines, adhesion molecules, and cell survival proteins. Various preclinical, clinical, and animal studies suggest that curcumin has potential as an antiproliferative, anti-invasive, and antiangiogenic, as a mediator of chemoresistance, chemopreventive, and as a therapeutic agent. Thus, curcumin a spice once relegated to the kitchen shelf has moved into the clinic and may prove to be "Curecumin." Methodology and Objectives: The focus of this publication is to provide research on curcumin with scientific publications on curcumin indexed in PubMed, Google J-Gate including systematic reviews, randomized controlled trials (RCT's), observational studies, or case series reports for various potentially malignant disorders (PMD's) with special attention to studies on oral submucous fibrosis. This research will be valuable in terms of identifying opportunities to provide recommendations for future research, in terms of the populations to research, the types of interventions needed, the types of outcomes to be measured, the study designs needed, to initiate a pathway for a low-cost research plan for future clinical trials in this field with an emphasis on conducting studies in regions of the world where PMD's are prevalent. There is a lacunae for scientific review of curcumin for PMDs specially on OSMF. Appropriate therapeutic interventions are needed for the initial, intermediate, and advanced stages of the disease. High-quality RCTs should be initiated.

A Unique Digital Electrocardiographic Repository for the Development of Quantitative Electrocardiography and Cardiac Safety: The Telemetric and Holter ECG Warehouse (THEW)

PubMed Central

Couderc, Jean-Philippe

2010-01-01

The sharing of scientific data reinforces open scientific inquiry; it encourages diversity of analysis and opinion while promoting new research and facilitating the education of next generations of scientists. In this article, we present an initiative for the development of a repository containing continuous electrocardiographic information and their associated clinical information. This information is shared with the worldwide scientific community in order to improve quantitative electrocardiology and cardiac safety. First, we present the objectives of the initiative and its mission. Then, we describe the resources available in this initiative following three components: data, expertise and tools. The Data available in the Telemetric and Holter ECG Warehouse (THEW) includes continuous ECG signals and associated clinical information. The initiative attracted various academic and private partners whom expertise covers a large list of research arenas related to quantitative electrocardiography; their contribution to the THEW promotes cross-fertilization of scientific knowledge, resources, and ideas that will advance the field of quantitative electrocardiography. Finally, the tools of the THEW include software and servers to access and review the data available in the repository. To conclude, the THEW is an initiative developed to benefit the scientific community and to advance the field of quantitative electrocardiography and cardiac safety. It is a new repository designed to complement the existing ones such as Physionet, the AHA-BIH Arrhythmia Database, and the CSE database. The THEW hosts unique datasets from clinical trials and drug safety studies that, so far, were not available to the worldwide scientific community. PMID:20863512

Loss to follow-up before and after initiation of antiretroviral therapy in HIV facilities in Lilongwe, Malawi

PubMed Central

Tweya, Hannock; Oboho, Ikwo Kitefre; Gugsa, Salem T.; Phiri, Sam; Rambiki, Ethel; Banda, Rebecca; Mwafilaso, Johnbosco; Munthali, Chimango; Gupta, Sundeep; Bateganya, Moses; Maida, Alice

2018-01-01

Introduction Although several studies have explored factors associated with loss to follow-up (LTFU) from HIV care, there remains a gap in understanding how these factors vary by setting, volume of patient and patients’ demographic and clinical characteristics. We determined rates and factors associated with LTFU in HIV care Lilongwe, Malawi. Methods We conducted a retrospective cohort study of HIV-infected individuals aged 15 years or older at the time of registration for HIV care in 12 ART facilities, between April 2012 and March 2013. HIV-positive individuals who had not started ART (pre-ART patients) were clinically assessed to determine ART eligibility at registration and during clinic follow-up visits. ART-eligible patients were initiated on triple antiretroviral combination. Study data were abstracted from patients’ cards, facility ART registers or electronic medical record system from the date of registration for HIV care to a maximum follow-up period of 24 months. Descriptive statistics were undertaken to summarize characteristics of the study patients. Separate univariable and multivariable poisson regression models were used to explore factors associated with LTFU in pre-ART and ART care. Results A total of 10,812 HIV-infected individuals registered for HIV care. Of these patients, 1,907 (18%) and 8,905 (82%) enrolled in pre-ART and ART care, respectively. Of the 1,907 pre-ART patients, 490 (26%) subsequently initiated ART and were included in both the pre-ART and ART analyses. The LTFU rates among patients in pre-ART and ART care were 48 and 26 per 100 person-years, respectively. Of the 9,105 ART patients with reasons for starting ART, 2,451 (27%) were initiated on ART because of pregnancy or breastfeeding (Option B+) status. Multivariable analysis showed that being ≥35 years and female were associated with decreased risk of LTFU in the pre-ART and ART phases of HIV care. However, being in WHO clinical stage 3 (adjusted risk ratio (aRR) 1.35, 95% confidence interval (CI): 1.20–1.51) and stage 4 (aRR 1.87, 95% CI: 1.62–2.18), body mass index ≤ 18.4 (aRR 1.24, 95% CI: 1.11–1.39) at ART initiation, poor adherence to clinic appointments (aRR 4.55, 95% CI: 4.16–4.97) and receiving HIV care in rural facilities (aRR 2.32, 95% CI: 1.94–2.87) were associated with increased risk of LTFU among ART patients. Being re-initiated on ART once (aRR 0.20, 95% CI: 0.17–0.22), more than once (aRR 0.06, 95% CI: 0.05–0.07), and being enrolled at a low-volume facility (aRR 0.25, 95% CI: 0.20–0.30) were associated with decreased risk of LTFU from ART care. Conclusion A sizeable proportion of ART LTFU occurred among women enrolled during pregnancy or breast-feeding. Non- compliance to clinic and receiving ART in a rural facility or high-volume facility were associated with increased risk of LTFU from ART care. Developing effective interventions that target high-risk subgroups and contexts may help reduce LTFU from HIV care. PMID:29373574

Comparative effectiveness of antihypertensive therapeutic classes and treatment strategies in the initiation of therapy in primary care patients: a Distributed Ambulatory Research in Therapeutics Network (DARTNet) study.

PubMed

Bronsert, Michael R; Henderson, William G; Valuck, Robert; Hosokawa, Patrick; Hammermeister, Karl

2013-01-01

Few comparative effectiveness studies of treatment strategies using antihypertensive therapeutic classes in hypertension control have been assessed in a primary care environment. The objectives are to compare the effectiveness of common antihypertensive therapeutic classes initiated as monotherapy and of fixed-dose combinations (FDCs), free-equivalent combinations (FECs), and monotherapy on hypertension control. This article reports observational comparative effectiveness analyses of data electronically extracted from electronic health records. The study population consisted of 8,676 patients with an incident prescription for an antihypertensive agent of a total of 79,176 patients receiving antihypertensive therapy in 33 geographically diverse primary care clinics. The main measures were reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) and rates of attaining goals per the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7). There were small, clinically insignificant differences in blood pressure reductions between the monotherapy classes. Higher rates of blood pressure control were obtained when patients were initiated on an angiotensin-converting enzyme inhibitor than a thiazide or thiazide-like diuretic (47.8% vs 39.9%) or a β-blocker versus a thiazide (45.9% vs 39.9%). Patients initiated on FDCs had significantly larger reductions in blood pressure than patients initiated on FECs (-17.3 vs -12.0 mm Hg SBP; -10.1 vs -6.0 mm Hg DBP) or monotherapy (-17.3 vs -13.6 mm Hg SBP; -10.1 vs -7.9 mm Hg DBP). Rates of attaining JNC7 goals also were better for FDCs than FECs (57.2% vs 42.5%) and for FDCs versus monotherapy (57.2% vs 44.9%). Patients initiated on angiotensin-converting enzyme inhibitors and β-blockers had slightly higher rates of blood pressure control. The use of FDCs as initial therapy is more effective in the control of hypertension than monotherapy or FECs.

Exploring the initial steps of the testing process: frequency and nature of pre-preanalytic errors.

PubMed

Carraro, Paolo; Zago, Tatiana; Plebani, Mario

2012-03-01

Few data are available on the nature of errors in the so-called pre-preanalytic phase, the initial steps of the testing process. We therefore sought to evaluate pre-preanalytic errors using a study design that enabled us to observe the initial procedures performed in the ward, from the physician's test request to the delivery of specimens in the clinical laboratory. After a 1-week direct observational phase designed to identify the operating procedures followed in 3 clinical wards, we recorded all nonconformities and errors occurring over a 6-month period. Overall, the study considered 8547 test requests, for which 15 917 blood sample tubes were collected and 52 982 tests undertaken. No significant differences in error rates were found between the observational phase and the overall study period, but underfilling of coagulation tubes was found to occur more frequently in the direct observational phase (P = 0.043). In the overall study period, the frequency of errors was found to be particularly high regarding order transmission [29 916 parts per million (ppm)] and hemolysed samples (2537 ppm). The frequency of patient misidentification was 352 ppm, and the most frequent nonconformities were test requests recorded in the diary without the patient's name and failure to check the patient's identity at the time of blood draw. The data collected in our study confirm the relative frequency of pre-preanalytic errors and underline the need to consensually prepare and adopt effective standard operating procedures in the initial steps of laboratory testing and to monitor compliance with these procedures over time.

CD133+ tumor initiating cells in a syngenic murine model of pancreatic cancer respond to Minnelide.

PubMed

Banerjee, Sulagna; Nomura, Alice; Sangwan, Veena; Chugh, Rohit; Dudeja, Vikas; Vickers, Selwyn M; Saluja, Ashok

2014-05-01

Pancreatic adenocarcinoma is the fourth leading cause for cancer-related mortality with a survival rate of less than 5%. Late diagnosis and lack of effective chemotherapeutic regimen contribute to these grim survival statistics. Relapse of any tumor is largely attributed to the presence of tumor-initiating cells (TIC) or cancer stem cells (CSC). These cells are considered as hurdles to cancer therapy as no known chemotherapeutic compound is reported to target them. Thus, there is an urgent need to develop a TIC-targeted therapy for pancreatic cancer. We isolated CD133(+) cells from a spontaneous pancreatic ductal adenocarcinoma mouse model and studied both surface expression, molecular markers of pancreatic TICs. We also studied tumor initiation properties by implanting low numbers of CD133(+) cells in immune competent mice. Effect of Minnelide, a drug currently under phase I clinical trial, was studied on the tumors derived from the CD133(+) cells. Our study showed for the first time that CD133(+) population demonstrated all the molecular markers for pancreatic TIC. These cells initiated tumors in immunocompetent mouse models and showed increased expression of prosurvival and proinvasive proteins compared to the CD133(-) non-TIC population. Our study further showed that Minnelide was very efficient in downregulating both CD133(-) and CD133(+) population in the tumors, resulting in a 60% decrease in tumor volume compared with the untreated ones. As Minnelide is currently under phase I clinical trial, its evaluation in reducing tumor burden by decreasing TIC as well as non-TIC population suggests its potential as an effective therapy. ©2014 AACR.

Effects of point massage of liver and stomach channel combined with pith and trotter soup on postpartum lactation start time.

PubMed

Luo, Qiong; Hu, Yin; Zhang, Hui

2017-10-01

Delay in lactation initiation causes maternal anxiety and subsequent adverse impact on maternal exclusive breast feeding. It is important to explore a safe and convenient way to promote lactation initiation. The feasibility of point massage of liver and stomach channel combined with pith and trotter soup on prevention of delayed lactation initiation was investigated in the present study. 320 women were enrolled and randomly divided into four groups, control group (80 women), point massage group (80 women), pith and trotter soup group (80 women), and massage + soup group (80 women) to compare the lactation initiation time. We found that women in point massage group, pith and trotter soup group and massage + soup group had earlier initiation of lactation compared with control group. Women in massage + soup group had the earliest initiation time of lactation. There were significant differences between massage + soup group and pith and trotter soup group. But, there were no significant differences between massage + soup group and massage group. We conclude that point massage of the liver and stomach channel is easy to operate and has the preventive effect on delayed lactation initiation. Impact statement What is already known on this subject: Initiation of lactation is a critical period in postpartum milk secretion. Delays in lactation initiation lead to maternal anxiety and have an adverse impact on maternal exclusive breastfeeding. Sucking frequently by babies and mammary massage might be effective but insufficient for delayed lactation initiation. What the results of this study add: We found in the present study that lactation initiation is significantly earlier in women receiving routine nursing combined with point massage of liver and stomach channel, or pith trotters soup, or massage of liver and stomach channel with pith and trotters soup than in a control group receiving routine nursing. These three methods are all effective, while the most effective method is point massage combined with pith trotter soup. There was no maternal drug allergy, postpartum bleeding or other adverse reactions noted in all women. What the implications are of these findings for clinical practice and/or further research: The present study suggested that the application of point massage in clinic might be useful for preventing lack of milk postpartum by delayed lactation initiation and improving the exclusive breastfeeding rate. Further research might explore that molecular mechanism of lactation promotion by point massage using blood samples or animal models.

Change management and clinical engagement: critical elements for a successful clinical information system implementation.

PubMed

Detwiller, Maureen; Petillion, Wendy

2014-06-01

Moving a large healthcare organization from an old, nonstandardized clinical information system to a new user-friendly, standards-based system was much more than an upgrade to technology. This project to standardize terminology, optimize key processes, and implement a new clinical information system was a large change initiative over 4 years that affected clinicians across the organization. Effective change management and engagement of clinical stakeholders were critical to the success of the initiative. The focus of this article was to outline the strategies and methodologies used and the lessons learned.

Agreement between the results of meta-analyses from case reports and from clinical studies regarding the efficacy of laronidase therapy in patients with mucopolysaccharidosis type I who initiated enzyme replacement therapy in adult age: An example of case reports meta-analyses as an useful tool for evidence-based medicine in rare diseases.

PubMed

Sampayo-Cordero, Miguel; Miguel-Huguet, Bernat; Pardo-Mateos, Almudena; Moltó-Abad, Marc; Muñoz-Delgado, Cecilia; Pérez-López, Jordi

2018-02-01

Case reports might have a prominent role in the rare diseases field, due to the small number of patients affected by one such disease. A previous systematic review regarding the efficacy of laronidase therapy in patients with mucopolysaccharidosis type I (MPS-I) who initiated enzyme replacement therapy (ERT) in adult age has been published. The review included a meta-analysis of 19 clinical studies and the description of eleven case reports. It was of interest to perform a meta-analysis of those case reports to explore the role of such meta-analyses as a tool for evidence-based medicine in rare diseases. The study included all case reports with standard treatment regimen. Primary analysis was the percentage of case reports showing an improvement in a specific outcome. Only when that percentage was statistically higher than 5%, the improvement was confirmed as such. The outcomes that accomplished this criterion were ranked and compared to the GRADE criteria obtained by those same outcomes in the previous meta-analysis of clinical studies. There were three outcomes that had a significant improvement: Urine glycosaminoglycans, liver volume and 6-minute walking test. Positive and negative predictive values, sensitivity and specificity for the results of the meta-analysis of case reports as compared to that of clinical studies were 100%, 88.9%, 75% and 100%, respectively. Accordingly, absolute (Rho=0.82, 95%CI: 0.47 to 0.95) and relative agreement (Kappa=0.79, 95%CI: 0.593 to 0.99) between the number of case reports with improvement in a specific outcome and the GRADE evidence score for that outcome were good. Sensitivity analysis showed that agreement between the meta-analysis of case reports and that of the clinical studies were good only when using a strong confirmatory strategy for outcome improvement in case reports. We found an agreement between the results of meta-analyses from case reports and from clinical studies in the efficacy of laronidase therapy in patients with MPS-I who initiated ERT in adult age. This agreement suggests that combining case reports quantitatively, rather than analyzing them separately or qualitatively, may improve conclusions in the field of rare diseases. Copyright © 2018 Elsevier Inc. All rights reserved.

[What everybody should know about good clinical practices].

PubMed

Osorio, Lyda

2015-01-01

An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

Rates and Reasons for Early Change of First HAART in HIV-1-Infected Patients in 7 Sites throughout the Caribbean and Latin America

PubMed Central

Cesar, Carina; Shepherd, Bryan E.; Krolewiecki, Alejandro J.; Fink, Valeria I.; Schechter, Mauro; Tuboi, Suely H.; Wolff, Marcelo; Pape, Jean W.; Leger, Paul; Padgett, Denis; Madero, Juan Sierra; Gotuzzo, Eduardo; Sued, Omar; McGowan, Catherine C.; Masys, Daniel R.; Cahn, Pedro E.

2010-01-01

Background HAART rollout in Latin America and the Caribbean has increased from approximately 210,000 in 2003 to 390,000 patients in 2007, covering 62% (51%–70%) of eligible patients, with considerable variation among countries. No multi-cohort study has examined rates of and reasons for change of initial HAART in this region. Methodology Antiretroviral-naïve patients > = 18 years who started HAART between 1996 and 2007 and had at least one follow-up visit from sites in Argentina, Brazil, Chile, Haiti, Honduras, Mexico and Peru were included. Time from HAART initiation to change (stopping or switching any antiretrovirals) was estimated using Kaplan-Meier techniques. Cox proportional hazards modeled the associations between change and demographics, initial regimen, baseline CD4 count, and clinical stage. Principal Findings Of 5026 HIV-infected patients, 35% were female, median age at HAART initiation was 37 years (interquartile range [IQR], 31–44), and median CD4 count was 105 cells/uL (IQR, 38–200). Estimated probabilities of changing within 3 months and one year of HAART initiation were 16% (95% confidence interval (CI) 15–17%) and 28% (95% CI 27–29%), respectively. Efavirenz-based regimens and no clinical AIDS at HAART initiation were associated with lower risk of change (hazard ratio (HR) = 1.7 (95% CI 1.1–2.6) and 2.1 (95% CI 1.7–2.5) comparing neverapine-based regimens and other regimens to efavirenz, respectively; HR = 1.3 (95% CI 1.1–1.5) for clinical AIDS at HAART initiation). The primary reason for change among HAART initiators were adverse events (14%), death (5.7%) and failure (1.3%) with specific toxicities varying among sites. After change, most patients remained in first line regimens. Conclusions Adverse events were the leading cause for changing initial HAART. Predictors for change due to any reason were AIDS at baseline and the use of a non-efavirenz containing regimen. Differences between participant sites were observed and require further investigation. PMID:20531956

Characterization of Patients with Amyotrophic Lateral Sclerosis attending the Muscular Dystrophy Association-Supported Clinics in Puerto Rico.

PubMed

Deliz, Brenda; Ramos, Kathya; Pérez, Cynthia M

2018-03-01

To evaluate the sociodemographic characteristics and clinical and functional profile of amyotrophic lateral sclerosis (ALS) patients evaluated at Puerto Rico's Muscular Dystrophy Association-supported (MDA) clinics. A retrospective review of 76 medical records of ALS patients evaluated at any of four MDA-sponsored clinics in Puerto Rico. The mean age of diagnosis was 57.4 ± 11.1 yrs. Most of the patients (52.3%) were women. The majority of the cases were sporadic (48.7%). Over 40% of the patients were diagnosed at one year or earlier. Patients with initial upper extremity involvement (63.2%) were diagnosed earlier (≤ 6 months) than any of the others. The most common presentation of the disease overall was lower extremity weakness (34.2%), which was followed by a bulbar presentation (31.6%). There was a marked difference between men and women in disease presentation, with bulbar involvement in 75% of the women. This study characterized a sample of ALS patients in Puerto Rico who are receiving services at the MDA-sponsored clinics. Puerto Rican patients have similarities with published data from the United States and other countries, including: sporadic pattern, initial symptoms in extremities, and time to diagnosis. Major differences are that the disease was more common in women than in men and that a higher than expected percentage of patients presented with bulbar onset. This may partly account for the overall predominance of the disease in women over men as found in our study, since the bulbar presentation has been reported to be more common in women. Studies with a greater number of patients are needed to determine whether our findings are reproducible. This study will serve as a basis for designing future analytic studies regarding etiology or the factors that might modulate disease progression.

Use of Subjective Global Assessment, Patient-Generated Subjective Global Assessment and Nutritional Risk Screening 2002 to evaluate the nutritional status of non-critically ill patients on parenteral nutrition.

PubMed

Badia-Tahull, M B; Cobo-Sacristán, S; Leiva-Badosa, E; Miquel-Zurita, M E; Méndez-Cabalerio, N; Jódar-Masanés, R; Llop-Talaverón, J

2014-02-01

To evaluate the nutritional status of non-critically ill digestive surgery patients at the moment of parenteral nutrition initiation using three different nutritional test tools and to study their correlation. To study the association between the tests and the clinical and laboratory parameters used in the follow-up of PN treatment. Prospective study over 4 months. Anthropometric and clinical variables were recorded. Results of Subjective Global Assessment; Patient-Generated Subjective Global Assessment; and Nutritional Risk Screening 2002 were compared applying kappa test. Relationship between the clinical and laboratory parameters with Subjective Global Assessment was studied by multinominal regression and with the other two tests by multiple linear regression models. Age and sex were included as adjustment variables. Malnutrition in 45 studied patients varied from 51% to 57%. Subjective Global Assessment correlated well with Patient-Generated Subjective Global Assessment and Nutritional Risk Screening 2002 (κ = 0531 p = 0.000). The test with the greatest correlation with the clinical and analytical variables was the Nutritional Risk Screening 2002. Worse nutritional state in this test was associated with worse results in albumin (B = -0.087; CI = -0.169/-0.005], prealbumin (B = -0.005; CI = [-0.011/-0.001]), C-reactive protein (B = 0.006;CI = [0.001/ 0.011]) and leukocytes (B = 0.134; CI = [0.031/0.237]) at the en of parenteral nutrition treatment. Half of the digestive surgery patients were at malnutritional risk at the moment of initiating parenteral nutrition. Nutritional Risk Screening 2002 was the test with best association with the parameters used in the clinical follow-up of parenteral nutrition treated patients. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Clinical utility of MRI and SPECT in the diagnosis of cognitive impairment referred to memory clinic.

PubMed

Guinane, John; Ng, Boon Lung

2018-05-01

ABSTRACTBackground:Despite of their limited availability and potential for significant variation between and within each modality, this is the first study to prospectively measure the clinical utility of MRI and/or SPECT brain scanning in addition to the routine diagnostic workup of patients presenting to memory clinic. A single center study was conducted over a convenience of 12-month sampling period. For each patient referred for MRI and/or SPECT scanning, the primary geriatrician or psychogeriatrician was asked to assign an initial diagnosis. The initial diagnosis was then compared with the final consensus diagnosis after any scans or neuropsychology testing had been completed. During the 12-month study period, 66 patients (26%) were referred for scans out of a total of 253 patients included in the study. There were 16/44 (36%) positive MRI outcomes and 13/35 (37%) positive SPECT outcomes. The diagnosis changed consistent with the MRI scan findings in 11/44 (25%) and changed consistent with the SPECT scan findings in 9/35 (26%). Potentially reversible pathology was identified in a single patient, 1/50 (2%), via an MRI scan that suggested normal pressure hydrocephalus. The number needed to test for one positive outcome was 3.8 (95% CI 2.0-23.3), 6.0 (95% CI NA), and 1.7 (95% CI 1.3-2.5) for MRI only, SPECT only, and MRI and SPECT together, respectively. The clinical utility of MRI and/or SPECT scanning in this study may be broadly superior to the available international evidence, and further research is needed to identify predictors of positive scan outcomes.

Comparing Pain and Depressive Symptoms of Chronic Opioid Therapy Patients Receiving Dose Reduction and Risk Mitigation Initiatives With Usual Care.

PubMed

Thakral, Manu; Walker, Rod L; Saunders, Kathleen; Shortreed, Susan M; Parchman, Michael; Hansen, Ryan N; Ludman, Evette; Sherman, Karen J; Dublin, Sascha; Von Korff, Michael

2018-01-01

Dose reduction and risk mitigation initiatives have been recommended to reduce opioid-related risks among patients receiving chronic opioid therapy (COT), but questions remain over whether these initiatives worsen pain control and quality of life. In 2014 to 2015, we interviewed 1,588 adult COT patients within a health care system in Washington State and compared those who received dose reduction and risk mitigation initiatives in primary care clinics (intervention) with patients in comparable health care settings without initiatives (control). The primary outcomes were pain assessed using the pain, enjoyment, and general activity (PEG) scale, a 3-item scale to assess global pain intensity and interference, with secondary measures including depression (Patient Health Questionnaire-8 scale). Generalized estimating equations for linear regression models were used to estimate differences in mean scores between intervention and control sites. Estimated differences, adjusted for patient characteristics and weighted for nonresponse, between patients at intervention and control clinics were not clinically significant for the PEG (-.03, 95% confidence interval = -.25 to .19) or Patient Health Questionnaire-8 (-.64, 95% confidence interval = -1.19 to -.08). We found no evidence that COT patients in clinics with dose reduction and risk mitigation initiatives had clinically meaningful differences in pain intensity, interference with activities and enjoyment of life, or depressive symptoms compared with control health care settings. This article evaluates the effect of dose reduction and risk mitigation initiatives, such as those recently recommended by the Centers for Disease Control and Prevention, to reduce risks associated with COT on global pain and interference, depressive symptoms, and perceived pain relief and bothersomeness of side effects. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada).

PubMed

Tarride, J E; Harrington, K; Balfour, R; Simpson, P; Foord, L; Anderson, L; Lakey, W

2011-01-01

To evaluate the My Health Matters! (MHM) program, a multifaceted workplace intervention relying on education and awareness, early detection and disease management with a focus on risk factors for metabolic syndrome. The MHM program was offered to 2,000 public servants working in more than 30 worksites in British Columbia, Canada. The MHM program included a health risk assessment combined with an opportunity to attend an on-site screening and face-to-face call back visits and related on-site educational programs. Clinical and economic outcomes were collected over time in this one-year prospective study coupled with administrative and survey data. Forty three per cent of employees (N=857) completed the online HRA and 23 per cent (N=447) attended the initial clinical visit with the nurse. Risk factors for metabolic syndrome were identified in more than half of those attending the clinical visit. The number of risk factors significantly decreased by 15 per cent over six months (N=141). The cost per employee completing the HRA was $205 while the cost per employee attending the initial clinical visit was $394. Eighty-two per cent of employees would recommend the program to other employers. This study supports that workplace interventions are feasible, sustainable and valued by employees. As such, this study provides a new framework for implementing and evaluating workplace interventions focussing on metabolic disorders.

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

PubMed

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

2017-04-01

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

Risk of seizure recurrence after achieving initial seizure freedom on the ketogenic diet.

PubMed

Taub, Katherine S; Kessler, Sudha Kilaru; Bergqvist, A G Christina

2014-04-01

Few studies have examined the long-term sustainability of complete seizure freedom on the ketogenic diet (KD). The purpose of this study was to describe the risk of seizure recurrence in children who achieved at least 1 month of seizure freedom on the KD, and to assess clinical features associated with sustained seizure freedom. Records of patients initiated on the KD at The Children's Hospital of Philadelphia (CHOP) from 1991 to 2009 were reviewed. Subjects who attained seizure freedom for at least 1 month within 2 years were included in the study. Seizure frequency was recorded based on caregiver-reported seizure diaries as unchanged, improved, or worse compared to baseline. Those patients with seizure freedom ≥1 year were compared to those with seizure freedom <1 year in terms of demographics, age of seizure onset, number of antiepileptic drugs (AEDs) prior to KD, and epilepsy classification. Of 276 patients initiated on the KD, 65 patients (24%) attained seizure freedom for a minimum of 1 month. The majority of these patients had daily seizures. The median time to seizure freedom after KD initiation was 1.5 months. Seizures recurred in 53 patients (82%), with a median time to seizure recurrence of 3 months. However, seizure frequency after initial recurrence remained far less than baseline. No clinical features were identified as risk factors for seizure recurrence. Seizure recurrence on the KD after 1 month of seizure freedom most often occurred as occasional breakthrough seizures and not a return to baseline seizure frequency. This study provides evidence to support the continued use of the KD in patients with initial seizure freedom even after breakthrough seizures. A PowerPoint slide summarizing this article is available for download in the Supporting Information section here. Wiley Periodicals, Inc. © 2014 International League Against Epilepsy.

Enhancing clinical evidence by proactively building quality into clinical trials.

PubMed

Meeker-O'Connell, Ann; Glessner, Coleen; Behm, Mark; Mulinde, Jean; Roach, Nancy; Sweeney, Fergus; Tenaerts, Pamela; Landray, Martin J

2016-08-01

Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight. The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials ("quality-by-design"), such that trials are feasible to conduct and important errors are prevented rather than remediated. A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality-by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning. Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality-by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach. The Clinical Trials Transformation Initiative quality-by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality-by-design workshops highlighted the value of active discussions incorporating the different perspectives within and external to an organization (e.g. clinical investigators, research site staff, and trial participants) in improving trial design. Workshop participants also recognized the value of focusing oversight on those aspects of the trial where errors would have a major impact on participant safety and reliability of results. Applying the Clinical Trials Transformation Initiative quality-by-design recommendations and principles should enable organizations to prioritize the most critical determinants of a trial's quality, identify non-essential activities that can be eliminated to streamline trial conduct and oversight, and formulate appropriate plans to define, avoid, mitigate, monitor, and address important errors. © The Author(s) 2016.

Comorbidity of Deployment-Related Posttraumatic Disorders and Their Treatment with Cognitive-Behavioral Group

DTIC Science & Technology

2011-04-01

traumatised soldiers will be presented in this article . Initial experiences with the group therapy program will be discussed. 15. SUBJECT TERMS 16...clinical impression and the SCID-II questionnaire (Structurel Clinical Interview for DSM-IV1) for personality disorders. 89% showed clinical evidence...group therapy, newly developed in Berlin, for traumatised soldiers will be presented in this article . Initial experiences with the group therapy program

Collaborative Initiative on Fetal Alcohol Spectrum Disorders: Methodology of Clinical Projects

PubMed Central

Mattson, Sarah N.; Foroud, Tatiana; Sowell, Elizabeth R.; Jones, Kenneth Lyons; Coles, Claire D.; Fagerlund, Åse; Autti-Rämö, Ilona; May, Philip A.; Adnams, Colleen M.; Konovalova, Valentina; Wetherill, Leah; Arenson, Andrew D.; Barnett, William K.; Riley, Edward P.

2009-01-01

The Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) was created in 2003 to further understanding of fetal alcohol spectrum disorders. Clinical and basic science projects collect data across multiple sites using standardized methodology. This paper describes the methodology being used by the clinical projects that pertain to assessment of children and adolescents. Domains being addressed are dysmorphology, neurobehavior, 3D facial imaging, and brain imaging. PMID:20036488

The Southeast Asian Influenza Clinical Research Network: development and challenges for a new multilateral research endeavor.

PubMed

Higgs, Elizabeth S; Hayden, Frederick G; Chotpitayasunondh, Tawee; Whitworth, Jimmy; Farrar, Jeremy

2008-04-01

The Southeast Asia Influenza Clinical Research Network (SEA ICRN) (www.seaclinicalresearch.org) is a recently developed multilateral, collaborative partnership that aims to advance scientific knowledge and management of human influenza through integrated clinical investigation. The partnership of hospitals and institutions in Indonesia, Thailand, United Kingdom, United States, and Viet Nam was established in late 2005 after agreement on the general principles and mission of the initiative and after securing initial financial support. The establishment of the SEA ICRN was both a response to the re-emergence of the highly pathogenic avian influenza A(H5N1) virus in Southeast Asia in late 2003 and an acknowledgment that clinical trials on emerging infectious diseases require prepared and coordinated research capacity. The objectives of the Network also include building sustainable research capacity in the region, compliance with international standards, and prompt dissemination of information and sharing of samples. The scope of research includes diagnosis, pathogenesis, treatment and prevention of human influenza due to seasonal or novel viruses. The Network has overcome numerous logistical and scientific challenges but has now successfully initiated several clinical trials. The establishment of a clinical research network is a vital part of preparedness and an important element during an initial response phase to a pandemic.

Long-Term Major Clinical Outcomes in Patients With Long Chain Fatty Acid Oxidation Disorders Before and After Transition to Triheptanoin Treatment—A Retrospective Chart Review

PubMed Central

Vockley, Jerry; Marsden, Deborah; McCracken, Elizabeth; DeWard, Stephanie; Barone, Amanda; Hsu, Kristen; Kakkis, Emil

2015-01-01

Background Long chain fatty acid oxidation disorders (LC-FAOD) are caused by defects in the metabolic pathway that converts stored long-chain fatty acids into energy, leading to a deficiency in mitochondrial energy production during times of physiologic stress and fasting. Severe and potentially life threatening clinical manifestations include rhabdomyolysis, hypoglycemia, hypotonia/weakness, cardiomyopathy and sudden death. We present the largest cohort of patients to date treated with triheptanoin, a specialized medium odd chain (C7) triglyceride, as a novel energy source for the treatment of LC-FAOD. Methods This was a retrospective, comprehensive medical record review study of data from 20 of a total 24 patients with LC-FAOD who were treated for up to 12.5 years with triheptanoin, as part of a compassionate use protocol. Clinical outcomes including hospitalization event rates, number of hospitalization days/year, and abnormal laboratory values were determined for the total period of the study before and after triheptanoin treatment, as well as for specified periods before and after initiation of triheptanoin treatment. Other events of interest were documented including rhabdomyolysis, hypoglycemia, and cardiomyopathy. Results LC-FAOD in these 20 subjects was associated with 320 hospitalizations from birth to the end date of study. The mean hospitalization days/year decreased significantly by 67% during the period after triheptanoin initiation (n=15; 5.76 vs 17.55 vs; P=0.0242) and a trend toward a 35% lower hospitalization event rate was observed in the period after triheptanoin initiation compared with the before-treatment period (n=16 subjects >6 months of age; 1.26 vs 1.94; P=0.1126). The hypoglycemia event rate per year in 9 subjects with hypoglycemia problems declined significantly by 96% (0.04 vs 0.92; P=0.0091) and related hospitalization days/year were also significantly reduced (n=9; 0.18 vs 8.42; P=0.0257). The rhabdomyolysis hospital event rate in 11 affected subjects was similar before and after treatment but the number of hospitalization days/year trended lower in the period after triheptanoin initiation (n=9; 2.36 vs 5.94; P=0.1224) and peak CK levels trended toward a 68% decrease from 85,855 to 27,597 units in 7 subjects with reported peak CK values before and after treatment (P=0.1279). Triheptanoin was generally well tolerated. Gastrointestinal symptoms were the most commonly reported side effects. Conclusions This retrospective study represents the largest analysis reported to date of treatment of LC-FAOD with triheptanoin. The data suggest that triheptanoin improves the course of disease by decreasing the incidence and duration of major clinical manifestations and should be the focus of prospective investigations. Significant heterogeneity in the routine clinical care provided to subjects during the periods studied and the natural variation of clinical course of LC-FAODs with time emphasize the need additioanl study of the use of triheptanoin. PMID:26116311

Development of a pharmacy resident rotation to expand decentralized clinical pharmacy services.

PubMed

Hill, John D; Williams, Jonathan P; Barnes, Julie F; Greenlee, Katie M; Cardiology, Bcps-Aq; Leonard, Mandy C

2017-07-15

The development of a pharmacy resident rotation to expand decentralized clinical pharmacy services is described. In an effort to align with the initiatives proposed within the ASHP Practice Advancement Initiative, the department of pharmacy at Cleveland Clinic, a 1,400-bed academic, tertiary acute care medical center in Cleveland, Ohio, established a goal to provide decentralized clinical pharmacy services for 100% of patient care units within the hospital. Patient care units that previously had no decentralized pharmacy services were evaluated to identify opportunities for expansion. Metrics analyzed included number of medication orders verified per hour, number of pharmacy dosing consultations, and number of patient discharge counseling sessions. A pilot study was conducted to assess the feasibility of this service and potential resident learning opportunities. A learning experience description was drafted, and feedback was solicited regarding the development of educational components utilized throughout the rotation. Pharmacists who were providing services to similar patient populations were identified to serve as preceptors. Staff pharmacists were deployed to previously uncovered patient care units, with pharmacy residents providing decentralized services on previously covered areas. A rotating preceptor schedule was developed based on geographic proximity and clinical expertise. An initial postimplementation assessment of this resident-driven service revealed that pharmacy residents provided a comparable level of pharmacy services to that of staff pharmacists. Feedback collected from nurses, physicians, and pharmacy staff also supported residents' ability to operate sufficiently in this role to optimize patient care. A learning experience developed for pharmacy residents in a large medical center enabled the expansion of decentralized clinical services without requiring additional pharmacist full-time equivalents. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Family Physician Clinical Inertia in Glycemic Control among Patients with Type 2 Diabetes

PubMed Central

Lang, Valerija Bralić; Marković, Biserka Bergman; Kranjčević, Ksenija

2015-01-01

Background Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. Material/Methods This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15–25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. Results A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Conclusions Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control. PMID:25652941

Family physician clinical inertia in glycemic control among patients with type 2 diabetes.

PubMed

Bralić Lang, Valerija; Bergman Marković, Biserka; Kranjčević, Ksenija

2015-02-05

Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15-25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control.

Guidelines for the Clinical Evaluation of Psychoactive Drugs in Infants and Children.

ERIC Educational Resources Information Center

Food and Drug Administration (DHEW), Washington, DC.

These guidelines are intended to help those who design and conduct investigations of psychopharmacologic agents in children. A progression of studies in four phases is advocated. First, early short term studies should establish single and multiple dose safety baselines. Second, early pilot efficacy studies may be initiated jointly with longer…

Clinical Subtypes of Dementia with Lewy Bodies Based on the Initial Clinical Presentation.

PubMed

Morenas-Rodríguez, Estrella; Sala, Isabel; Subirana, Andrea; Pascual-Goñi, Elba; Sánchez-Saudinós, MaBelén; Alcolea, Daniel; Illán-Gala, Ignacio; Carmona-Iragui, María; Ribosa-Nogué, Roser; Camacho, Valle; Blesa, Rafael; Fortea, Juan; Lleó, Alberto

2018-06-04

Dementia with Lewy bodies (DLB) is a heterogeneous disease in which clinical presentation, symptoms, and evolution widely varies between patients. To investigate the existence of clinical subtypes in DLB based on the initial clinical presentation. 81 patients with a clinical diagnosis of probable DLB were consecutively included. All patients underwent a neurological evaluation including a structured questionnaire about neuropsychiatric symptoms and sleep, an assessment of motor impairment (Unified Parkinson Disease Rating Scale subscale III), and a formal neuropsychological evaluation. Onset of core symptoms (hallucinations, parkinsonism, and fluctuations) and dementia were systematically reviewed from medical records. We applied a K-means clustering method based on the initial clinical presentation. Cluster analysis yielded three different groups. Patients in cluster I (cognitive-predominant, n = 46) presented more frequently with cognitive symptoms (95.7%, n = 44, p < 0.001), and showed a longer duration from onset to DLB diagnosis (p < 0.001) than the other clusters. Patients in cluster II (neuropsychiatric-predominant, n = 22) were older at disease onset (78.1±5 versus 73.6±6.1 and 73.6±4.2 in clusters I and III, respectively, both p < 0.01), presented more frequently with psychotic symptoms (77.3%, n = 17), and had a shorter duration until the onset of hallucinations (p < 0.001). Patients in cluster III (parkinsonism-predominant, n = 13) showed a shorter time from onset to presence of parkinsonism (p < 0.001) and dementia (0.008). Three subtypes of clinical DLB can be defined when considering the differential initial presentations. The proposed subtypes have distinct clinical profiles and progression patterns.

Net present value approaches for drug discovery.

PubMed

Svennebring, Andreas M; Wikberg, Jarl Es

2013-12-01

Three dedicated approaches to the calculation of the risk-adjusted net present value (rNPV) in drug discovery projects under different assumptions are suggested. The probability of finding a candidate drug suitable for clinical development and the time to the initiation of the clinical development is assumed to be flexible in contrast to the previously used models. The rNPV of the post-discovery cash flows is calculated as the probability weighted average of the rNPV at each potential time of initiation of clinical development. Practical considerations how to set probability rates, in particular during the initiation and termination of a project is discussed.

Neuropsychiatric manifestations in late-onset urea cycle disorder patients.

PubMed

Serrano, Mercedes; Martins, Cecilia; Pérez-Dueñas, Belén; Gómez-López, Lilian; Murgui, Empar; Fons, Carmen; García-Cazorla, Angels; Artuch, Rafael; Jara, Fernando; Arranz, José A; Häberle, Johannes; Briones, Paz; Campistol, Jaume; Pineda, Mercedes; Vilaseca, Maria A

2010-03-01

Inherited urea cycle disorders represent one of the most common groups of inborn errors of metabolism. Late-onset urea cycle disorders caused by partial enzyme deficiencies may present with unexpected clinical phenotypes. We report 9 patients followed up in our hospital presenting late-onset urea cycle disorders who initially manifested neuropsychiatric/neurodevelopmental symptoms (the most prevalent neuropsychiatric/neurodevelopmental diagnoses were mental retardation, attention-deficit hyperactivity disorder [ADHD], language disorder, and delirium). Generally, these clinical pictures did not benefit from pharmacological treatment. Conversely, dietary treatment improved the symptoms. Regarding biochemical data, 2 patients showed normal ammonium but high glutamine levels. This study highlights the fact that neuropsychiatric/neurodevelopmental findings are common among the initial symptomatology of late-onset urea cycle disorders. The authors recommend that unexplained or nonresponsive neuropsychiatric/neurodevelopmental symptoms appearing during childhood or adolescence be followed by a study of ammonia and amino acid plasmatic levels to rule out a urea cycle disorder.

Barriers to diagnosing and managing hypertension - a qualitative study in Australian general practice.

PubMed

Howes, Faline; Hansen, Emily; Williams, Danielle; Nelson, Mark

2010-07-01

Elevated blood pressure (BP) is a major modifiable risk factor. However hypertension still remains underdiagnosed, untreated or suboptimally treated. This study aimed to identify and explore barriers to initiating medication and treating elevated BP to target levels in the general practice setting. Six focus groups involving 30 clinicians were audio recorded, transcribed in full and analysed for common emerging themes using an iterative thematic analysis. After making the decision to commence treatment, medication initiation was relatively straightforward. Clinical uncertainty about true underlying BP, distrust of measurement technology, and distrust of the evidence underpinning hypertension management were expressed. Patient age, gender and comorbidity influenced treatment strategy. Related themes included perceived patient attitude, clinical inertia, and patient centred care. Systems issues included lack of resources and lack of time. The management of an asymptomatic chronic disease within a patient centred, encounter based primary care context can be challenging.

Metabolomic responses to lumacaftor/ivacaftor in cystic fibrosis.

PubMed

Kopp, Benjamin T; McCulloch, Scott; Shrestha, Chandra L; Zhang, Shuzhong; Sarzynski, Lisa; Woodley, Frederick W; Hayes, Don

2018-05-01

Cystic fibrosis (CF) is a life-limiting disease caused by a defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Lumacaftor/Ivacaftor is a novel CFTR modulator approved for patients that are homozygous for Phe508del CFTR, but its clinical effectiveness varies amongst patients, making it difficult to determine clinical responders. Therefore, identifying biochemical biomarkers associated with drug response are clinically important for follow-up studies. Serum metabolomics was performed on twenty patients with CF pre- and 6-month post-Lumacaftor/Ivacaftor response via Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). Correlation with clinical variables was performed. Metabolomics analysis demonstrated 188 differentially regulated metabolites between patients pre- and post-Lumacaftor/Ivacaftor initiation, with a predominance of lipid and amino acid alterations. The top 30 metabolites were able to differentiate pre- and post-Lumacaftor/Ivacaftor status in greater than 90% of patients via a random-forest confusion matrix. Alterations in bile acids, phospholipids, and bacteria-associated metabolites were the predominant changes associated with drug response. Importantly, changes in metabolic patterns were associated with clinical responders. Selected key lipid and amino acid metabolic pathways were significantly affected by Lumacaftor/Ivacaftor initiation and similar pathways were affected in clinical responders. Targeted metabolomics may provide useful and relevant biomarkers of CFTR modulator responses. © 2018 Wiley Periodicals, Inc.

Real-World Use and Outcomes of ALK-Positive Crizotinib-Treated Metastatic NSCLC in US Community Oncology Practices: A Retrospective Observational Study.

PubMed

Reynolds, Craig; Masters, Elizabeth T; Black-Shinn, Jenny; Boyd, Marley; Mardekian, Jack; Espirito, Janet L; Chioda, Marc

2018-05-29

Around 3⁻5% of non-small cell lung cancers (NSCLC) are ALK-positive. Crizotinib was the first approved ALK inhibitor from clinical trials. However, there are less data on the utilization and patient outcomes associated with crizotinib in real-world clinical practice. This was a retrospective, observational study of adult crizotinib-treated ALK-positive metastatic NSCLC patients who received treatment between 1 September 2011 and 31 October 2014, with follow up through 31 December 2015. Data were obtained via programmatic queries of the US Oncology Network/McKesson Specialty Health electronic health record database, supplemented with chart abstraction. Overall survival (OS) and time to treatment failure (TTF) were estimated from crizotinib initiation using the Kaplan⁻Meier (KM) method. Of the n = 199 ALK-positive crizotinib-treated patients meeting eligibility criteria, crizotinib was prescribed as first line (1 L) in n = 123 (61.8%). The majority (88.9%) had confirmed adenocarcinoma histology and 32.2% had brain metastases at initial diagnosis. Median age at crizotinib initiation was 60.2 years (range 27.1⁻88.2); 54.8% were never smokers, 33.7% were former smokers. Treatment of 250 mg, twice daily, was most commonly prescribed (89.5%) with the dose unchanged from an initial dose in 79.4% of patients. The primary discontinuation reason was progression ( n = 91, 58.7%). Patients (3.2%) were identified as discontinuing crizotinib as a result of treatment-related toxicity. With median follow-up time of 13.0 months (min⁻max = 0.03⁻46.6), median OS from crizotinib initiation was 33.8 months (95% CI = 24.3⁻38.8). Median TTF was 10.4 months. Crizotinib usage evaluated within the real-world setting is consistent with prior phase III clinical trial data, and illustrates the real-world effectiveness of crizotinib.

Fluid dynamics vascular theory of brain and inner-ear function in traumatic brain injury: a translational hypothesis for diagnosis and treatment.

PubMed

Shulman, Abraham; Strashun, Arnold M

2009-01-01

It is hypothesized that in all traumatic brain injury (TBI) patients with a clinical history of closed or penetrating head injury, the initial head trauma is associated with a vibratory sensation and noise exposure, with resultant alteration in vascular supply to the structures and contents of the fluid compartments of brain and ear (i.e., the fluid dynamics vascular theory of brain-inner-ear function [FDVTBE]). The primary etiology-head trauma-results in an initial fluctuation, interference, or interaction in the normal fluid dynamics between brain and labyrinth of the inner ear, with a resultant clinical diversity of complaints varying in time of onset and severity. Normal function of the brain and ear is a reflection of a normal state of homeostasis between the fluid compartments in the brain of cerebrospinal fluid and perilymph-endolymph in the labyrinth of the ear. The normal homeostasis in the structures and contents between the two fluid compartment systems--intracerebral and intralabyrinthine--is controlled by mechanisms involved in the maintenance of normal pressures, water and electrolyte content, and neurotransmitter activities. The initial pathophysiology (a reflection of an alteration in the vascular supply to the brain-ear) is hypothesized to be an initial acute inflammatory response, persistence of which results in ischemia and an irreversible alteration in the involved neural substrates of brain-ear. Clinically, a chronic multisymptom complex becomes manifest. The multisymptom complex, individual for each TBI patient regardless of the diagnostic TBI category (i.e., mild, moderate, or severe), initially reflects processes of inflammation and ischemia which, in brain, result in brain volume loss identified as neurodegeneration and hydrocephalus ex vacuo or an alteration in cerebrospinal fluid production (i.e., pseudotumor cerebri) and, in ear, secondary endolymphatic hydrops with associated cochleovestibular complaints of hearing loss, tinnitus, vertigo, ear blockage, and hyperacusis. The FDVTBE integrates and translates a neurovascular hypothesis for Alzheimer's disease to TBI. This study presents an FDVTBE hypothesis of TBI to explain the clinical association of head trauma (TBI) and central nervous system neurodegeneration with multisensory complaints, highlighted by and focusing on cochleovestibular complaints. A clinical case report, previously published for demonstration of the cerebrovascular medical significance of a particular type of tinnitus, and evidence-based basic science and clinical medicine are cited to provide objective evidence in support and demonstration of the FDVTBE.

An augmented SMS intervention to improve access to antenatal CD4 testing and ART initiation in HIV-infected pregnant women: a cluster randomized trial.

PubMed

Dryden-Peterson, Scott; Bennett, Kara; Hughes, Michael D; Veres, Adrian; John, Oaitse; Pradhananga, Rosina; Boyer, Matthew; Brown, Carolyn; Sakyi, Bright; van Widenfelt, Erik; Keapoletswe, Koona; Mine, Madisa; Moyo, Sikhulile; Asmelash, Aida; Siedner, Mark; Mmalane, Mompati; Shapiro, Roger L; Lockman, Shahin

2015-01-01

Less than one-third of HIV-infected pregnant women eligible for combination antiretroviral therapy (ART) globally initiate treatment prior to delivery, with lack of access to timely CD4 results being a principal barrier. We evaluated the effectiveness of an SMS-based intervention to improve access to timely antenatal ART. We conducted a stepped-wedge cluster randomized trial of a low-cost programmatic intervention in 20 antenatal clinics in Gaborone, Botswana. From July 2011-April 2012, 2 clinics were randomly selected every 4 weeks to receive an ongoing clinic-based educational intervention to improve CD4 collection and to receive CD4 results via an automated SMS platform with active patient tracing. CD4 testing before 26 weeks gestation and ART initiation before 30 weeks gestation were assessed. Three-hundred-sixty-six ART-naïve women were included, 189 registering for antenatal care under Intervention and 177 under Usual Care periods. Of CD4-eligible women, 100 (59.2%) women under Intervention and 79 (50.6%) women under Usual Care completed CD4 phlebotomy before 26 weeks gestation, adjusted odds ratio (aOR, adjusted for time that a clinic initiated Intervention) 0.87 (95% confidence interval [CI]0.47-1.63, P = 0.67). The SMS-based platform reduced time to clinic receipt of CD4 test result from median of 16 to 6 days (P<0.001), was appreciated by clinic staff, and was associated with reduced operational cost. However, rates of ART initiation remained low, with 56 (36.4%) women registering under Intervention versus 37 (24.2%) women under Usual Care initiating ART prior to 30 weeks gestation, aOR 1.06 (95%CI 0.53-2.13, P = 0.87). The augmented SMS-based intervention delivered CD4 results more rapidly and efficiently, and this type of SMS-based results delivery platform may be useful for a variety of tests and settings. However, the intervention did not appear to improve access to timely antenatal CD4 testing or ART initiation, as obstacles other than CD4 impeded ART initiation during pregnancy.

Recurrence of Phaeochromocytoma and Abdominal Paraganglioma After Initial Surgical Intervention

PubMed Central

Mullan, Karen R; Atkinson, A Brew; Eatock, Fiona C; Wallace, Helen; Gray, Moyra; Hunter, Steven J

2015-01-01

Background Clinical and biochemical follow up after surgery for phaeochromocytoma is essential with long term studies demonstrating recurrence frequencies between 6% and 23%. Aim To examine the characteristics and frequency of tumour recurrence in a regional endocrine referral centre, in patients with surgical resection of phaeochromocytoma (P) and abdominal paraganglioma (AP). Methods We identified a cohort of 52 consecutive patients who attended our Regional Endocrinology & Diabetes Centre and retrospectively reviewed their clinical, biochemical and radiological data (between 2002 and 2013). After confirmation of early post-operative remission by negative biochemical testing, tumour recurrence was defined by demonstration of catecholamine excess with confirmatory imaging. Results Phaeochromocytoma was confirmed histologically in all cases (43:P, 9:AP, mean-age:53years). Open adrenalectomy was performed in 20 cases and laparoscopically in 32. Hereditary phaeochromocytoma was confirmed by genetic analysis in 12 (23%) patients. Median follow up time from initial surgery was 47 months, (range: 12 - 296 months), 49 patients had no evidence of tumour recurrence at latest follow-up. Three patients (6%) demonstrated tumour development, one in a patient with VHL which occurred in a contralateral adrenal gland, one sporadic case had local recurrence, and an adrenal tumour occurred in a patient with a SDHB gene mutation who had a previous bladder tumour. After initial surgery, the tumours occurred at 8.6, 12.0 and 17.7 years respectively. Conclusion In this study tumour development occurred in 6% of patients. Although tumour rates were low, careful and sustained clinical and biochemical follow up is advocated, as new tumour development or recurrence may occur long after the initial surgery is performed. PMID:26170485

Traditional circumcision during manhood initiation rituals in the Eastern Cape, South Africa: a pre-post intervention evaluation

PubMed Central

Peltzer, Karl; Nqeketo, Ayanda; Petros, George; Kanta, Xola

2008-01-01

Background Circumcisions undertaken in non-clinical settings can have significant risks of serious adverse events, including death. The aim of this study was to test an intervention for safe traditional circumcision in the context of initiation into manhood among the Xhosa, Eastern Cape, South Africa. Methods Traditional surgeons and nurses registered with the health department were trained over five days on ten modules including safe circumcision, infection control, anatomy, post-operative care, detection and early management of complications and sexual health education. Initiates from initiation schools of the trained surgeons and nurses were examined and interviewed on 2nd, 4th, 7th and 14th day after circumcision. Results From 192 initiates physically examined at the 14th day after circumcision by a trained clinical nurse high rates of complications were found: 40 (20.8%) had mild delayed wound healing, 31 (16.2%) had a mild wound infection, 22 (10.5%) mild pain and 20 (10.4%) had insufficient skin removed. Most traditional surgeons and nurses wore gloves during operation and care but did not use the recommended circumcision instrument. Only 12% of the initiates were circumcised before their sexual debut and they reported a great deal of sexual risk behaviour. Conclusion Findings show weak support for scaling up traditional male circumcision. PMID:18284673

Phacoemulsification with intravitreal bevacizumab injection in diabetic patients with macular edema and cataract.

PubMed

Akinci, Arsen; Batman, Cosar; Ozkilic, Ersel; Altinsoy, Ali

2009-01-01

The purpose of this study was to evaluate the results of phacoemulsification with intravitreal bevacizumab injection in patients with diabetic clinically significant macular edema and cataract. The records of 31 patients with diabetic clinically significant macular edema and cataract, which would interfere with macular laser photocoagulation, who have undergone phacoemulsification with intravitreal injection of 1.25 mg bevacizumab were retrospectively evaluated. All patients had undergone focal or modified grid laser photocoagulation 1 month after the surgery. All patients were evaluated by spectral optical coherence tomography/optical coherence tomography SLO before and 1 and 3 months after the surgery beyond complete ophthalmologic examination. The best-corrected visual acuity (BCVA) levels and central macular thickness (CMT) recorded at the first and third months after the surgery were compared with the initial values. Paired samples t test was used for statistical analysis. The mean initial BCVA was 0.10 +/- 0.04 (range, 0.05-0.2). The mean BCVA at the first and third months after the surgery were 0.47 +/- 0.16 (standard deviation) (range, 0.2-0.5) and 0.51 +/- 0.12 (standard deviation) (range, 0.3-0.6), respectively. The BCVA level recorded at the first and third months after the surgery were significantly higher than the initial BCVA (P = 0.004). The mean initial CMT was 387.5 +/- 109.5 microm. The mean CMT at the first and third months after the surgery were 292.7 +/- 57.2 and 275.5 +/- 40.3. The CMT recorded at the first and third months after the surgery were significantly lower than the initial CMT (P < 0.001, P < 0.001). Phacoemulsification with intravitreal injection of bevacizumab provides improvement in clinically significant macular edema with a gain in BCVA in patients with diabetes with clinically significant macular edema and cataract.

Preventing Caries in Preschoolers: Successful Initiation of an Innovative Community-Based Clinical Trial in Navajo Nation Head Start

PubMed Central

Quissell, David O.; Bryant, Lucinda L.; Braun, Patricia A.; Cudeii, Diana; Johs, Nikolas; Smith, Vongphone L.; George, Carmen; Henderson, William G.; Albino, Judith

2014-01-01

Navajo Nation children have the greatest prevalence of early childhood caries in the United States. This protocol describes an innovative combination of community-based participatory research and clinical trial methods to rigorously test a lay native Community Oral Health Specialists-delivered oral health intervention, with the goal of reducing the progression of disease and improving family knowledge and behaviors. Methods/Design This cluster-randomized trial designed by researchers at the Center for Native Oral Health Research at the University of Colorado in conjunction with members of the Navajo Nation community compares outcomes between the manualized 2-year oral health fluoride varnish-oral health promotion intervention and usual care in the community (child-caregiver dyads from 26 Head Start classrooms in each study arm; total of 1016 dyads). Outcome assessment includes annual dental screening and an annual caregiver survey of knowledge, attitudes and behaviors; collection of cost data will support cost-benefit analyses. Discussion The study protocol meets all standards required of randomized clinical trials. Aligned with principles of community-based participatory research, extended interaction between members of the Navajo community and researchers preceded study initiation, and collaboration between project staff and a wide variety of community members informed the study design and implementation. We believe the benefits of adding CBPR methods to those of randomized clinical studies outweigh the barriers and constraints, especially in studies of health disparities and in challenging settings. When done well, this innovative mix of methods will increase the likelihood of valid results that communities can use. PMID:24469238

Evaluating the Difference between Virtual and Paper-Based Clinical Cases in Family Medicine Undergraduate Education

PubMed Central

Cagran, Branka

2018-01-01

Introduction A “virtual patient” is defined as a computer program which simulates real patients' cases. The aim of this study was to determine whether the inclusion of virtual patients affects the level of factual knowledge of family medicine students at the undergraduate level. Methods This was a case-controlled prospective study. The students were randomly divided into experimental (EG: N = 51) and control (CG: N = 48) groups. The students in the EG were asked to practice diagnosis using virtual patients instead of the paper-based clinical cases which were solved by the students in the CG. The main observed variable in the study was knowledge of family medicine, determined by 50 multiple choice questions (MCQs) about knowledge of family medicine. Results There were no statistically significant differences in the groups' initial knowledge. At the final assessment of knowledge, there were no statistically significant differences between the groups, but there was a statistically significant difference between their initial and final knowledge. Conclusions The study showed that adding virtual patient cases to the curriculum, instead of paper clinical cases, did not affect the level of factual knowledge about family medicine. Virtual patients can be used, but a significant educational outcome is not expected. PMID:29568779

Initiation of biological agents in patients with ankylosing spondylitis: results of a Delphi study by the ASAS Group

PubMed Central

Pham, T; van der Heijde, D; Calin, A; Khan, M; van der Linden, S.; Bellamy, N; Dougados, M

2003-01-01

Background: There is ample evidence of important symptomatic efficacy of tumour necrosis factor α (TNFα) inhibition in ankylosing spondylitis (AS). Moreover, studies suggest that anti-TNF could be considered as the first disease controlling antirheumatic treatment (DC-ART) for AS. Objective: To determine precisely which patients with AS are most likely to benefit from anti-TNFα treatment because of the cost and possible long term side effects of such treatment. Methods: Assessment in Ankylosing Spondylitis (ASAS) members were asked to use a Delphi technique to name the characteristics of patients with AS for whom they would start DC-ART, in three different clinical presentations (isolated axial involvement, peripheral arthritis, enthesitis). Results: Among the 62 invited ASAS members, more than 50% actively participated in the four phases of definition according to the Delphi technique. For each of the three clinical presentations, a combination of five to six domains was proposed, with an evaluation instrument and a cut off point defining a minimum level of activity for each domain. Conclusion: This study provides a profile for a patient with AS for considering initiation of biological agents that reflects the opinion of the ASAS members, using a Delphi exercise. Further studies are required to assess their relevance and their consistency with clinical practice. PMID:12922951

Diagnostic utility, safety, and cost-effectiveness of emergency department-initiated early scheduled technetium-99m single photon emission computed tomography imaging followed by expedited outpatient cardiac clinic visits in acute chest pain syndromes.

PubMed

Wong, Raymond C; Sinha, Arvind Kumar; Mahadevan, Malcolm; Yeo, Tiong Cheng

2010-09-01

Conventional emergency department (EMD) approach to triaging acute chest pain syndromes may lead to unnecessary admissions, resulting to in-hospital bed occupancy and increased healthcare costs. We explore the diagnostic utility of early (less than a week) outpatient scheduled single photon emission computed tomography (SPECT) in intermediate-risk chest pain subjects who presented to EMD with non-diagnostic electrocardiogram and negative serum troponin level. Additionally, we intend to study the safety and cost-effectiveness of such a strategy. We conduct a prospective, non-randomized study of 108 subjects who fit the inclusion criteria. After SPECT studies, all subjects were evaluated in the cardiac clinic within 2 weeks of EMD visits. Final diagnosis of coronary artery disease and subsequent disposition to standard medical therapy or follow-on angiography were decided by incorporating pre-test clinical data and SPECT results. Adverse events defined as myocardial infarction and cardiac death was tracked between EMD visit and eventual therapy (either medical therapy or coronary revascularization). Finally, cost-effectiveness was determined based on estimated cost and days of hospitalization saved between standard strategies of ward admission for further evaluation versus the present early outpatient SPECT-based workflow. Among 108 subjects (mean age 58 years, 59% male) included for analysis, 82 (76%) had normal perfusion status. There was no statistical difference in baseline characteristics and prior ischemic heart disease history between groups. In the 26 abnormal perfusion subjects, seven had follow-on coronary angiography in which three were found to have significant stenotic coronary lesions, but only one had intervention performed. There was an unscheduled coronary angiography in the normal perfusion group that yielded normal coronary anatomy. There was no adverse clinical event in both groups. Compared with standard strategy, early outpatient SPECT initiated by EMD physicians followed by cardiac clinic evaluation resulted in 2.9 days of hospitalization or $781.23 saved per patient per EMD visit. EMD-initiated early SPECT studies followed by cardiac clinic evaluation in intermediate-risk acute chest pain syndromes with non-diagnostic ECG and negative serum troponin levels carries excellent diagnostic and therapeutic utility, in addition to being safe and cost-effective.

The Role of Surgery in the Clinical Management of Primary Gastrointestinal Non-Hodgkin's Lymphoma.

PubMed

MacQueen, Ian T; Shannon, Evan M; Dawes, Aaron J; Ostrzega, Nora; Russell, Marcia M; Maggard-Gibbons, Melinda

2015-10-01

Primary gastrointestinal non-Hodgkin's lymphoma (PGINHL) is a heterogeneous family of tumors, with treatment modalities including chemotherapy, surgery, and radiotherapy. Because the role of surgery in PGINHL remains disputed, this study aims to assess the impact of operative resection on survival. We used a pathology database to identify all cases of PGINHL diagnosed at a single academic-affiliated medical center from 1988 to 2013. Demographic and clinical data were abstracted from the medical record. We summarized the clinical courses of patients with PGINHL and then performed a survival analysis to compare overall and disease-free survival, stratified by demographic and clinical variables. We identified 33 patients diagnosed with PGINHL during the study period. Of 29 who subsequently received treatment at the institution, 15 initially underwent chemotherapy, 10 underwent surgical resection, and 4 underwent surgery for other reasons such as diagnosis without resection or management of disease complications. Three patients suffered surgical complications and two of these patients died. We found no difference in overall survival between patients receiving surgical resection and patients managed initially with chemotherapy. This case series supports a continued role for surgical resection in the management of patients with PGINHL, though anticipated benefits should be weighed against the risk of complications.

Biophysical Approaches for Oral Wound Healing: Emphasis on Photobiomodulation

PubMed Central

Khan, Imran; Arany, Praveen

2015-01-01

Significance: Oral wounds can lead to significant pain and discomfort as well as affect overall general health due to poor diet and inadequate nutrition. Besides many biological and pharmaceutical methods being investigated, there is growing interest in exploring various biophysical devices that utilize electric, magnetic, ultrasound, pressure, and light energy. Recent Advances: Significant insight into mechanisms of these biophysical devices could provide a clear rationale for their clinical use. Preclinical studies are essential precursors in determining physiological mechanisms and elucidation of causal pathways. This will lead to development of safe and effective therapeutic protocols for clinical wound management. Critical Issues: Identification of precise events initiated by biophysical devices, specifically photobiomodulation—the major focus of this review, offers promising avenues in improving oral wound management. The primary phase responses initiated by the interventions that distinctly contribute to the therapeutic response must be clearly delineated from secondary phase responses. The latter events are a consequence of the wound healing process and must not be confused with causal mechanisms. Future Direction: Clinical adoption of these biophysical devices needs robust and efficacious protocols that can be developed by well-designed preclinical and clinical studies. Elucidation of the precise molecular mechanisms of these biophysical approaches could determine optimization of their applications for predictive oral wound care. PMID:26634185

Epidemiological findings and clinical and magnetic resonance presentations in subacute sclerosing panencephalitis.

PubMed

Cece, H; Tokay, L; Yildiz, S; Karakas, O; Karakas, E; Iscan, A

2011-01-01

Subacute sclerosing panencephalitis (SSPE) is a rare, progressive, inflammatory neurodegenerative disease. This study investigated the relationships of clinical stage with epidemiological and magnetic resonance imaging (MRI) findings in SSPE by retrospective review of 76 cases (57 male) diagnosed by typical periodic electroencephalographic features, clinical symptoms and elevated measles antibody titre in cerebrospinal fluid. Clinical stage at diagnosis was I or II in 48 patients, III in 25 and IV in three. Prominent findings at presentation were atonic/myoclonic seizures (57.9%) and mental deterioration with behaviour alteration (30.3%). Frequent MRI findings (13 - 32 patients) were subcortical, periventricular and cortical involvement and brain atrophy; the corpus callosum, basal ganglia, cerebellum and brainstem were less frequently involved. Five patients had pseudotumour cerebri. Cranial MRI at initial diagnosis was normal in 21 patients (19 stage I/II, two stage III/IV). Abnormal MRI findings were significantly more frequent in the later stages, thus a normal initial cranial MRI does not exclude SSPE, which should, therefore, be kept in mind in childhood demyelinating diseases even when the presentation is unusual.

JAK2 inhibitor therapy in myeloproliferative disorders: rationale, preclinical studies and ongoing clinical trials.

PubMed

Pardanani, A

2008-01-01

The recent identification of somatic mutations such as JAK2V617F that deregulate Janus kinase (JAK)-signal transducer and activator of transcription signaling has spurred development of orally bioavailable small-molecule inhibitors that selectively target JAK2 kinase as an approach to pathogenesis-directed therapy of myeloproliferative disorders (MPD). In pre-clinical studies, these compounds inhibit JAK2V617F-mediated cell growth at nanomolar concentrations, and in vivo therapeutic efficacy has been demonstrated in mouse models of JAK2V617F-induced disease. In addition, ex vivo growth of progenitor cells from MPD patients harboring JAK2V617F or MPLW515L/K mutations is also potently inhibited. JAK2 inhibitors currently in clinical trials can be grouped into those designed to primarily target JAK2 kinase (JAK2-selective) and those originally developed for non-MPD indications, but that nevertheless have significant JAK2-inhibitory activity (non-JAK2 selective). This article discusses the rationale for using JAK2 inhibitors for the treatment of MPD, as well as relevant aspects of clinical trial development for these patients. For instance, which group of MPD patients is appropriate for initial Phase I studies? Should JAK2V617F-negative MPD patients be included in the initial studies? What are the likely consequences of 'off-target' JAK3 and wild-type JAK2 inhibition? How should treatment responses be monitored?

Dental Cements for Luting and Bonding Restorations: Self-Adhesive Resin Cements.

PubMed

Manso, Adriana P; Carvalho, Ricardo M

2017-10-01

Self-adhesive resin cements combine easy application of conventional luting materials with improved mechanical properties and bonding capability of resin cements. The presence of functional acidic monomers, dual cure setting mechanism, and fillers capable of neutralizing the initial low pH of the cement are essential elements of the material and should be understood when selecting the ideal luting material for each clinical situation. This article addresses the most relevant aspects of self-adhesive resin cements and their potential impact on clinical performance. Although few clinical studies are available to establish solid clinical evidence, the information presented provides clinical guidance in the dynamic environment of material development. Copyright © 2017 Elsevier Inc. All rights reserved.

Case Report: Activity Diagrams for Integrating Electronic Prescribing Tools into Clinical Workflow

PubMed Central

Johnson, Kevin B.; FitzHenry, Fern

2006-01-01

To facilitate the future implementation of an electronic prescribing system, this case study modeled prescription management processes in various primary care settings. The Vanderbilt e-prescribing design team conducted initial interviews with clinic managers, physicians and nurses, and then represented the sequences of steps carried out to complete prescriptions in activity diagrams. The diagrams covered outpatient prescribing for patients during a clinic visit and between clinic visits. Practice size, practice setting, and practice specialty type influenced the prescribing processes used. The model developed may be useful to others engaged in building or tailoring an e-prescribing system to meet the specific workflows of various clinic settings. PMID:16622168

Clinical progression, acute urinary retention, prostate-related surgeries, and costs in patients with benign prostatic hyperplasia taking early versus delayed combination 5α-reductase inhibitor therapy and α-blocker therapy: a retrospective analysis.

PubMed

Morlock, Robert; Goodwin, Bridgett; Gomez Rey, Gabriel; Eaddy, Michael

2013-05-01

Two previous retrospective database analyses compared early combination therapy with an α-blocker (AB) and 5-α reductase inhibitor (5-ARI) to delayed combination therapy and found that patients receiving the delayed combination therapy were more likely to have clinical progression, acute urinary retention (AUR), and surgery. Although these studies indicate the clinical benefits of early treatment, both studies failed to take into account important baseline clinical measures, such as prostate-specific antigen (PSA) values. This study was designed to compare clinical and cost differences in men with benign prostatic hyperplasia (BPH) who initiated early versus delayed combination therapy with a 5-ARI + an AB, factoring in baseline PSA values. This retrospective claims data analysis assessed data from >14 million US men with linked medical data, pharmacy data, laboratory results, and enrollment information from January 1, 2000, to December 31, 2009. Men aged 50 or older and treated for BPH with a 5-ARI + an AB were identified. Patients were required to be eligible for services at least 6 months before and 12 months after the index medication date. Patients were assigned to 1 of 2 treatment groups based on therapy (early or delayed) and 3 cohorts based on availability of PSA laboratory values (patients with a PSA value, patients with a PSA value >1.5 and <10, and all patients). Using a logistic model, the likelihood of clinical progression (defined as the occurrence of AUR or prostate surgery) during the 12 months after the date of first prescription fill was compared between BPH patients receiving early versus delayed combination therapy. BPH-related medical costs (excluding pharmacy costs) were assessed using generalized linear models. Among the 13,551 patients identified for study inclusion, the highest risks for clinical progression, AUR, and prostate-related surgery were consistently demonstrated in patients with a PSA >1.5 and <10. Across all 3 cohorts, the delayed combination-treatment group was more likely to have clinical progression, AUR, and prostate-related surgeries versus the early combination-treatment group. The incremental difference in BPH-related costs between the delayed and early combination-treatment groups was $190 per patient overall; the greatest incremental difference ($397) was observed in patients with PSA >1.5 and <10. The results suggest that early initiation of combination therapy with 5-ARI + an AB, compared with delayed initiation, can reduce the risks for clinical progression, AUR, and prostate-related surgeries, as well as BPH-related medical costs, in patients with BPH. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

Pharmacoepidemiology of Clinically Relevant Hypothyroidism and Hypertension from Sunitinib and Sorafenib

PubMed Central

Aubert, Ronald E.; La‐Beck, Ninh M.; Clore, Gosia; Herrera, Vivian; Kourlas, Helen; Epstein, Robert S.; McLeod, Howard L.

2017-01-01

Abstract Background. Thyroid dysfunction and hypertension (HTN) have been sporadically reported with sunitinib (SUN) and sorafenib (SOR). Determination of the side effect incidence will enhance monitoring and management recommendations. Methods. An observational cohort study was performed using deidentified pharmacy claims data from a 3‐year period to evaluate patients prescribed SUN, SOR, or capecitabine (CAP; comparison group). The primary outcome was time to first prescription for thyroid replacement or HTN treatment. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated by Cox proportional hazards models. Results. A total of 20,061 patients were eligible for evaluation of thyroid replacement therapy, which was initiated in 11.6% of those receiving SUN (HR, 16.77; 95% CI, 13.54–20.76), 2.6% of those receiving SOR (HR, 3.47; 95% CI, 2.46–4.98), and 1% of those receiving CAP, with median time to initiation of 4 months (range, 1–35 months). A total of 14,468 patients were eligible for evaluation of HTN therapy, which was initiated in 21% of SUN recipients (HR, 4.91; 95% CI, 4.19–5.74), 14% of SOR recipients (HR, 3.25; 95% CI, 2.69–3.91), and 5% of CAP recipients, with median time to initiation of 1 month (range, 1–18 months) for SOR and 2 months (range, 1–25 months) for SUN. Conclusion. SUN and SOR significantly increased the risk for clinically relevant hypothyroidism; the risk was at least 4 times greater with SUN than with SOR. Patients receiving SUN and SOR had a similar elevated risk for clinically relevant HTN. These data provide robust measures of the incidence and time to onset of these clinically actionable adverse events. Implications for Practice. The side effect profiles for novel therapies are typically used to create monitoring and management recommendations using clinical trial data from patient populations that may not represent those seen in standard clinical practice. This analysis using a large pharmacy claims database better reflects typical patients treated with sorafenib or sunitinib outside of a clinical trial. The findings of increased need for thyroid replacement in patients receiving sunitinib compared with sorafenib and a similar increase in need for hypertension therapy with both agents can be used to form clinically relevant monitoring recommendations for these agents. PMID:28167571

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

PubMed

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

2011-09-01

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

Corticobasal degeneration initially developing motor versus non-motor symptoms: a comparative clinicopathological study.

PubMed

Ikeda, Chikako; Yokota, Osamu; Nagao, Shigeto; Ishizu, Hideki; Morisada, Yumi; Terada, Seishi; Nakashima, Yoshihiko; Akiyama, Haruhiko; Uchitomi, Yosuke

2014-09-01

Clinical presentations of pathologically confirmed corticobasal degeneration (CBD) vary, and the heterogeneity makes its clinical diagnosis difficult, especially when a patient lacks any motor disturbance in the early stage. We compared clinical and pathological features of four pathologically confirmed CBD cases that initially developed non-motor symptoms, including behavioural and psychiatric symptoms but without motor disturbance (CBD-NM), and five CBD cases that initially developed parkinsonism and/or falls (CBD-M). The age range at death for the CBD-NM and CBD-M subjects (58-85 years vs 45-67 years) and the range of disease duration (2-18 years vs 2-6 years) did not significantly differ between the groups. Prominent symptoms in the early stage of CBD-NM cases included self-centred behaviours such as frontotemporal dementia (n = 1), apathy with and without auditory hallucination (n = 2), and aggressive behaviours with delusion and visual hallucination (n = 1). Among the four CBD-NM cases, only one developed asymmetric motor disturbance, and two could walk without support throughout the course. Final clinical diagnoses of the CBD-NM cases were frontotemporal dementia (n = 2), senile psychosis with delirium (n = 1), and schizophrenia (n = 1). Neuronal loss was significantly less severe in the subthalamic nucleus and substantia nigra in the CBD-NM cases than in the CBD-M cases. The severity of tau pathology in all regions examined was comparable in the two groups. CBD cases that initially develop psychiatric and behavioural changes without motor symptoms may have less severe degenerative changes in the subthalamic nucleus and substantia nigra, and some CBD cases can lack motor disturbance not only in the early stage but also in the last stage of the course. © 2014 The Authors. Psychogeriatrics © 2014 Japanese Psychogeriatric Society.

Service impact of a national clinical leadership development programme: findings from a qualitative study.

PubMed

Fealy, Gerard M; McNamara, Martin S; Casey, Mary; O'Connor, Tom; Patton, Declan; Doyle, Louise; Quinlan, Christina

2015-04-01

The study reported here was part of a larger study, which evaluated a national clinical leadership development programme with reference to resources, participant experiences, participant outcomes and service impact. The aim of the present study was to evaluate the programme's service impact. Clinical leadership development develops competencies that are expressed in context. The outcomes of clinical leadership development occur at individual, departmental and organisational levels. The methods used to evaluate the service impact were focus groups, group interviews and individual interviews. Seventy participants provided data in 18 separate qualitative data collection events. The data contained numerous accounts of service development activities, initiated by programme participants, which improved service and/or improved the culture of the work setting. Clinical leadership development programmes that incorporate a deliberate service impact element can result in identifiable positive service outcomes. The nuanced relationship between leader development and service development warrants further investigation. This study demonstrates that clinical leadership development can impact on service in distinct and identifiable ways. Clinical leadership development programmes should focus on the setting in which the leadership competencies will be demonstrated. © 2013 John Wiley & Sons Ltd.

Incidence and risk factors for immune reconstitution inflammatory syndrome in an ethnically diverse HIV type 1-infected cohort.

PubMed

Ratnam, I; Chiu, C; Kandala, N-B; Easterbrook, P J

2006-02-01

It is estimated that 10%-25% of patients who start highly active antiretroviral therapy (HAART) experience immune reconstitution inflammatory syndrome (IRIS). Our objective was to determine the incidence, clinical spectrum, and predictors of IRIS in an ethnically diverse cohort of patients initiating HAART. A retrospective study of all patients starting HAART between 1 January 2000 and 31 August 2002 at a human immunodeficiency virus (HIV) clinic in London was performed. All laboratory measurements and data on antiretroviral therapies were obtained from the clinic database. Medical records were reviewed to identify clinical events consistent with IRIS during the 6 months after HAART was initiated. A total of 199 patients were included, of whom 50.8% were male, 59.3% were black African, 29.1% were white, and 10.5% were black Caribbean. The median baseline CD4 cell count and HIV RNA load were 174x10(6) cells/L (interquartile range [IQR], 82-285x10(6) cells/L) and 37,830 copies/mL (IQR, 4809-149,653 copies/mL), respectively. Forty-four patients (22.7%) experienced an IRIS event at a median of 12 weeks after HAART initiation (IQR, 4-24 weeks after initiation); 22 events (50%) involved genital herpes, 10 (23%) involved genital warts, 4 (9.0%) involved molluscum contagiosum, and 4 (9.0%) involved varicella zoster virus infection. Five patients had mycobacterial infections, 4 had hepatitis B, 1 had Pneumocystis jirovecci infection, and 1 had Kaposi sarcoma. The strongest independent predictors of IRIS were younger age at initiation of HAART (P=.003), baseline CD4 cell percentage of <10% (odds ratio [OR], 2.97; IQR, 1.17-7.55) compared with >15%, and ratio of CD4 cell percentage to CD8 cell percentage of <0.15 (OR, 3.45; 95% confidence interval, 1.27-9.1) compared with >0.3. Approximately one-quarter of patients who start HAART experience an IRIS event. The majority are dermatological, in particular genital herpes and warts. Patients with advanced immunodeficiency at HAART initiation are at greatest risk of developing IRIS and should be appropriately screened and monitored.

Use of Medicare Data to Identify Coronary Heart Disease Outcomes In the Women's Health Initiative (WHI)

PubMed Central

Hlatky, Mark A; Ray, Roberta M; Burwen, Dale R; Margolis, Karen L; Johnson, Karen C; Kucharska-Newton, Anna; Manson, JoAnn E; Robinson, Jennifer G; Safford, Monika M; Allison, Matthew; Assimes, Themistocles L; Bavry, Anthony A; Berger, Jeffrey; Cooper-DeHoff, Rhonda M; Heckbert, Susan R; Li, Wenjun; Liu, Simin; Martin, Lisa W; Perez, Marco V; Tindle, Hilary A; Winkelmayer, Wolfgang C; Stefanick, Marcia L

2015-01-01

Background Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials, or in clinical registry studies. The reliability of claims data for documenting outcomes is unknown. Methods and Results We linked records of Women's Health Initiative (WHI) participants aged 65 years and older to Medicare claims data, and compared hospitalizations that had diagnosis codes for acute myocardial infarction (MI) or coronary revascularization with WHI outcomes adjudicated by study physicians. We then compared the hazard ratios for active versus placebo hormone therapy based solely on WHI adjudicated events with corresponding hazard ratios based solely on claims data for the same hormone trial participants. Agreement between WHI adjudicated outcomes and Medicare claims was good for the diagnosis for MI (kappa = 0.71 to 0.74), and excellent for coronary revascularization (kappa=0.88 to 0.91). The hormone:placebo hazard ratio for clinical MI was 1.31 (95% confidence interval (CI) 1.03 to 1.67) based on WHI outcomes, and 1.29 (CI 1.00 to 1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (CI 0.88 to 1.35) based on WHI outcomes and 1.10 (CI 0.89 to 1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1,000 bootstrap replications. Conclusion Medicare claims may provide useful data on coronary heart disease outcomes among patients aged 65 years and older in clinical research studies. Clinical Trials Registration Information www.clinicaltrials.gov, Trial Number NCT00000611 PMID:24399330

Impact of a cystic fibrosis transmembrane conductance regulator (CFTR) modulator on high-dose ibuprofen therapy in pediatric cystic fibrosis patients.

PubMed

Bruch, Brittany A; Singh, Sachinkumar B; Ramsey, Laura J; Starner, Timothy D

2018-05-01

This study was undertaken to determine if a clinically relevant drug-drug interaction occurred between ibuprofen and lumacaftor/ivacaftor. Peak ibuprofen plasma concentrations were measured prior to and after lumacaftor/ivacaftor initiation. A Wilcoxon signed rank sum test was used to compare the values. Nine patients were included in the final analysis. Peak ibuprofen plasma concentrations decreased an average of 36.4 mcg/mL after initiation of lumacaftor/ivacaftor with a relative reduction of 41.7%. The average peak plasma concentration was 84.2 mcg/mL (SD = 10.9) prior to lumacaftor/ivacaftor initiation and 47.9 mcg/mL (SD = 16.4) following initiation (P = 0.0039). Peak concentrations occurred at an average of 100 min (SD = 30) and 107 min (SD = 40) prior to and following lumacaftor/ivacaftor initiation, respectively. We suggest a clinically relevant drug-drug interaction exists between ibuprofen and lumacaftor/ivacaftor. Lumacaftor may cause subtherapeutic ibuprofen plasma concentrations due to the induction of CYP enzymes and increased metabolism of ibuprofen. Based on this analysis, we have modified our use of ibuprofen in several patients after evaluation of this drug-drug interaction. © 2018 Wiley Periodicals, Inc.

A Predictive Study of Pre-Service Teachers and Success in Final Student Internship

ERIC Educational Resources Information Center

Ingle, Karen M.

2017-01-01

Student teaching provides the final pre-service clinical teaching experience of an initial teacher preparation program. Research that specifically studies the pre-service student teacher and predictive factors of student teaching is limited. Identifying predictive factors that contribute to the success of student interns' student teaching…

Thirteen Week Oral Toxicity Study of WR238605 with a Thirteen Week Recovery Period in Dogs. Volume 3

DTIC Science & Technology

1993-06-11

dogs will have been vaccinated against canine distemper , infectious canine hepatitis, leptospirosis, parainfluenza, parvo, oral papilloma, and...documented on the Clinical Veterinarian Log by the veterinarian prior to study initiation. Food: Purina Certified Canine Diet No. 5007 (Ralston

One Year Oral Toxicity Study of WR238605 Succinate in Dogs. Volume 1

DTIC Science & Technology

1997-07-18

previously vaccinated by the animal supplier against canine distemper , infectious canine hepatitis, oral Page 9 Contract No.: DAMD17-92-C-2001...documented on the Clinical Veterinarian Log by the veterinarian prior to study initiation. Certified Canine Diet No. 5007 (PMI Feeds Inc., St. Louis

Baseline genetic associations in the Parkinson's Progression Markers Initiative (PPMI).

PubMed

Nalls, Mike A; Keller, Margaux F; Hernandez, Dena G; Chen, Lan; Stone, David J; Singleton, Andrew B

2016-01-01

The Parkinson's Progression Marker Initiative is an international multicenter study whose main goal is investigating markers for Parkinson's disease (PD) progression as part of a path to a treatment for the disease. This manuscript describes the baseline genetic architecture of this study, providing not only a catalog of disease-linked variants and mutations, but also quantitative measures with which to adjust for population structure. Three hundred eighty-three newly diagnosed typical PD cases, 65 atypical PD and 178 healthy controls, from the Parkinson's Progression Marker Initiative study have been genotyped on the NeuroX or Immunochip arrays. These data are freely available to all researchers interested in pursuing PD research within the Parkinson's Progression Marker Initiative. The Parkinson's Progression Marker Initiative represents a study population with low genetic heterogeneity. We recapitulate known PD associations from large-scale genome-wide association studies and refine genetic risk score models for PD predictability (area under the curve, ∼0.74). We show the presence of six LRRK2 p.G2019S and nine GBA p.N370S mutation carriers. The Parkinson's Progression Marker Initiative study and its genetic data are useful in studies of PD biomarkers. The genetic architecture described here will be useful in the analysis of myriad biological and clinical traits within this study. © 2015 International Parkinson and Movement Disorder Society.

Improving the Implementation of Evidence-Based Clinical Practices in Adolescent Reproductive Health Care Services

PubMed Central

Romero, Lisa M.; Middleton, Dawn; Mueller, Trisha; Avellino, Lia; Hallum-Montes, Rachel

2015-01-01

Purpose The purposes of the study were to describe baseline data in the implementation of evidence-based clinical practices among health center partners as part of a community-wide teen pregnancy prevention initiative and to identify opportunities for health center improvement. Methods Health center partner baseline data were collected in the first year (2011) and before program implementation of a 5-year community-wide teen pregnancy prevention initiative. A needs assessment on health center capacity and implementation of evidence-based clinical practices was administered with 51 health centers partners in 10 communities in the United States with high rates of teen pregnancy. Results Health centers reported inconsistent implementation of evidence-based clinical practices in providing reproductive health services to adolescents. Approximately 94.1% offered same-day appointments, 91.1% had infrastructure to reduce cost barriers, 90.2% offered after-school appointments, and 80.4% prescribed hormonal contraception without prerequisite examinations or testing. Approximately three quarters provided visual and audio privacy in examination rooms (76.5%) and counseling areas (74.5%). Fewer offered a wide range of contraceptive methods (67.8%) and took a sexual health history at every visit (54.9%). Only 45.1% reported Quick Start initiation of hormonal contraception, emergency contraception (43.1%), or intrauterine devices (12.5%) were “always” available to adolescents. Conclusions The assessment highlighted opportunities for health center improvement. Strategies to build capacity of health center partners to implement evidence-based clinical practices may lead to accessibility and quality of reproductive health services for adolescents in the funded communities. PMID:26381918

Clinical presentation and treatment of septic arthritis in children.

PubMed

Moro-Lago, I; Talavera, G; Moraleda, L; González-Morán, G

The aim of this study is to determine the epidemiological features, clinical presentation, and treatment of children with septic arthritis. A retrospective review was conducted on a total of 141 children with septic arthritis treated in Hospital Universitario La Paz (Madrid) between the years 2000 to 2013. The patient data collected included, the joint affected, the clinical presentation, the laboratory results, the appearance, Gram stain result, and the joint fluid culture, as well as the imaging tests and the treatment. Most (94%) of the patients were less than 2 years-old. The most common location was the knee (52%), followed by the hip (21%). The septic arthritis was confirmed in 53%. No type of fever was initially observed in 49% of them, and 18% had an ESR (mm/h) or CRP (mg/l) less than 30 in the initial laboratory analysis. The joint fluid was purulent in 45% and turbid in 12%. The Gram stain showed bacteria in 4%. The fluid culture was positive in 17%. Staphylococcus aureus was the most common pathogen found, followed by Streptococcus agalactiae, Streptococcus pneumoniae, and Kingella kingae. Antibiotic treatment was intravenous administration for 7 days, followed by 21 days orally. Surgery was performed in 18% of cases. The diagnosis was only confirmed in 53% of the patients. Some of the confirmed septic arthritis did not present with the classical clinical/analytical signs, demonstrating that the traumatologist or paediatrician requires a high initial level of clinical suspicion of the disease. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Long-term follow-up in optimally treated and stable heart failure patients: primary care vs. heart failure clinic. Results of the COACH-2 study.

PubMed

Luttik, Marie Louise A; Jaarsma, Tiny; van Geel, Peter Paul; Brons, Maaike; Hillege, Hans L; Hoes, Arno W; de Jong, Richard; Linssen, Gerard; Lok, Dirk J A; Berge, Marjolein; van Veldhuisen, Dirk J

2014-11-01

It has been suggested that home-based heart failure (HF) management in primary care may be an alternative to clinic-based management in HF patients. However, little is known about adherence to HF guidelines and adherence to the medication regimen in these home-based programmes. The aim of the current study was to determine whether long-term follow-up and treatment in primary care is equally effective as follow-up at a specialized HF clinic in terms of guideline adherence and patient adherence, in HF patients initially managed and up-titrated to optimal treatment at a specialized HF clinic. We conducted a multicentre, randomized, controlled study in 189 HF patients (62% male, age 72 ± 11 years), who were assigned to follow-up either in primary care (n = 97) or in a HF clinic (n = 92). After 12 months, no differences between guideline adherence, as estimated by the Guideline Adherence Indicator (GAI-3), and patient adherence, in terms of the medication possession ratio (MPR), were found between treatment groups. There was no difference in the number of deaths (n = 12 in primary care and n = 8 in the HF clinic; P = 0.48), and hospital readmissions for cardiovascular (CV) reasons were also similar. The total number of unplanned non-CV hospital readmissions, however, tended to be higher in the primary care group (n = 22) than in the HF clinic group (n = 10; P = 0.05). Patients discharged after initial management in a specialized HF clinic can be discharged to primary care for long-term follow-up with regard to maintaining guideline adherence and patient adherence. However, the complexity of the HF syndrome and its associated co-morbidities requires continuous monitoring. Close collaboration between healthcare providers will be crucial in order to provide HF patients with optimal, integrated care. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

Healthcare-associated Pneumonia: Clinical Features and Retrospective Analysis Over 10 Years

PubMed Central

Qi, Fei; Zhang, Guo-Xin; She, Dan-Yang; Liang, Zhi-Xin; Wang, Ren-Tao; Yang, Zhen; Chen, Liang-An; Cui, Jun-Chang

2015-01-01

Background: Healthcare-associated pneumonia (HCAP) is associated with drug-resistant pathogens and high mortality, and there is no clear evidence that this is due to inappropriate antibiotic therapy. This study was to elucidate the clinical features, pathogens, therapy, and outcomes of HCAP, and to clarify the risk factors for drug-resistant pathogens and prognosis. Methods: Retrospective observational study among hospitalized patients with HCAP over 10 years. The primary outcome was 30-day all-cause hospital mortality after admission. Demographics (age, gender, clinical features, and comorbidities), dates of admission, discharge and/or death, hospitalization costs, microbiological results, chest imaging studies, and CURB-65 were analyzed. Antibiotics, admission to Intensive Care Unit (ICU), mechanical ventilation, and pneumonia prognosis were recorded. Patients were dichotomized based on CURB-65 (low- vs. high-risk). Results: Among 612 patients (mean age of 70.7 years), 88.4% had at least one comorbidity. Commonly detected pathogens were Acinetobacter baumannii, Pseudomonas aeruginosa, and coagulase-negative staphylococci. Initial monotherapy with β-lactam antibiotics was the most common initial therapy (50%). Mean age, length of stay, hospitalization expenses, ICU admission, mechanical ventilation use, malignancies, and detection rate for P. aeruginosa, and Staphylococcus aureus were higher in the high-risk group compared with the low-risk group. CURB-65 ≥3, malignancies, and mechanical ventilation were associated with an increased mortality. Logistic regression analysis showed that cerebrovascular diseases and being bedridden were independent risk factors for HCAP. Conclusion: Initial treatment of HCAP with broad-spectrum antibiotics could be an appropriate approach. CURB-65 ≥3, malignancies, and mechanical ventilation may result in an increased mortality. PMID:26481734

Is there an association between suicide attempt and delay of initiation of mood stabilizers in bipolar I disorder?

PubMed

Nery-Fernandes, Fabiana; Quarantini, Lucas C; Guimarães, José L; de Oliveira, Irismar R; Koenen, Karestan C; Kapczinski, Flavio; Miranda-Scippa, Ângela

2012-02-01

Little is known about the extent to which delay of initiation of mood-stabilizing treatment may influence outcomes in bipolar patients (BP). In this study, our aim was to investigate the association between delay of mood stabilizer treatment in bipolar patients and lifetime history of suicide attempts. A consecutive sample of 268 bipolar I outpatients from two teaching hospitals in Brazil was recruited. The assessment included a socio-demographic history form, a clinical interview regarding clinical variables and the Structured Clinical Interview for DSM-IV. Participants were divided into three groups: BP that initiated the first mood stabilizer in the same year of the first episode of the disease (FMS≤1), between 1 and 5 years after the first episode of the disease (15). The mean time from the first episode until the first mood stabilizer medication was 8.6 years (SD 9.8 years). The FMS>5 group, showed a higher lifetime prevalence of suicide attempts than the other two groups (PR=1.75, 95% CI: 1.24-2.47), p=0.001. These results remained significant after adjusting for potential confounders, (PR=1.82, 95% CI: 1.29-2.60), p=0.001. This study evaluated patients retrospectively and does not permit a cause-effect relationship. The present study supports the importance of early diagnosis and early intervention for BP in order to limit the potentially lethal impact of the disease. Copyright © 2011 Elsevier B.V. All rights reserved.

Healthcare-associated Pneumonia: Clinical Features and Retrospective Analysis Over 10 Years.

PubMed

Qi, Fei; Zhang, Guo-Xin; She, Dan-Yang; Liang, Zhi-Xin; Wang, Ren-Tao; Yang, Zhen; Chen, Liang-An; Cui, Jun-Chang

2015-10-20

Healthcare-associated pneumonia (HCAP) is associated with drug-resistant pathogens and high mortality, and there is no clear evidence that this is due to inappropriate antibiotic therapy. This study was to elucidate the clinical features, pathogens, therapy, and outcomes of HCAP, and to clarify the risk factors for drug-resistant pathogens and prognosis. Retrospective observational study among hospitalized patients with HCAP over 10 years. The primary outcome was 30-day all-cause hospital mortality after admission. Demographics (age, gender, clinical features, and comorbidities), dates of admission, discharge and/or death, hospitalization costs, microbiological results, chest imaging studies, and CURB-65 were analyzed. Antibiotics, admission to Intensive Care Unit (ICU), mechanical ventilation, and pneumonia prognosis were recorded. Patients were dichotomized based on CURB-65 (low- vs. high-risk). Among 612 patients (mean age of 70.7 years), 88.4% had at least one comorbidity. Commonly detected pathogens were Acinetobacter baumannii, Pseudomonas aeruginosa, and coagulase-negative staphylococci. Initial monotherapy with β-lactam antibiotics was the most common initial therapy (50%). Mean age, length of stay, hospitalization expenses, ICU admission, mechanical ventilation use, malignancies, and detection rate for P. aeruginosa, and Staphylococcus aureus were higher in the high-risk group compared with the low-risk group. CURB-65 ≥3, malignancies, and mechanical ventilation were associated with an increased mortality. Logistic regression analysis showed that cerebrovascular diseases and being bedridden were independent risk factors for HCAP. Initial treatment of HCAP with broad-spectrum antibiotics could be an appropriate approach. CURB-65 ≥3, malignancies, and mechanical ventilation may result in an increased mortality.

Lower Anogenital Tract Disease Therapy Outcomes, COMET, and CROWN: Call for Research Submissions.

PubMed

Andrews, Jeffrey

2015-10-01

There is a problem of inconsistent and inappropriate outcome selection for research studies. We can improve the relevance of research results for women and for their physicians and clinicians by encouraging researchers to critically evaluate outcome measures, and use valid, appropriate, standardized measures. To this purpose, and to facilitate synthesis of the evidence, outcomes reported by clinical studies should be standardized for different disease conditions through the development of core outcome sets (COS). There is an international effort for reaching consensus on outcome measures and establishing COS that represent agreed-upon standardized collections of outcome measures that will be reported in all studies within a clinical area. Across clinical specialties, the Core Outcome Measures in Effectiveness Trials (COMET) initiative launched in 2010. In 2014, the editors of women's health journals answered the challenge of COMET and formed the Core Outcomes in Women's Health initiative. The Journal of Lower Genital Tract Diseases is a participating member of the Core Outcomes in Women's Health consortium. There is broad inconsistency in outcome measures and reporting in the field of lower anogenital tract diseases. No core outcome sets currently exist. Suggested target conditions in anogenital disease are vulvar dermatoses, cervical intraepithelial neoplasia, and vulvodynia. Investigators are encouraged to conduct secondary systematic research to determine previously reported primary outcome measures and suggest domains for COS. Core Outcomes in Women's health initiative and COMET encourage the formation of consensus panels of stakeholders (researchers, health care providers, patients, and others) to recommend outcome domains and COS and then publish their report.

Diffusion of a Nurse-led Healthcare Innovation: Describing Certified Clinical Nurse Leader Integration Into Care Delivery.

PubMed

Bender, Miriam; Williams, Marjory; Su, Wei

2016-01-01

The Clinical Nurse Leader™ (CNL) initiative is in its 2nd decade. Despite a growing theoretical and empirical body of CNL knowledge, little is known about CNLs themselves or where and how their competencies are being integrated into care delivery across the country. The aim of this study was to describe certified CNL characteristics and roles as part of a larger study validating a model for CNL practice. This study used a descriptive analysis of survey data from a national sample of certified CNLs. Survey response rate was 19%. Sixty percent have greater than 10 years of RN experience, and 75% have additional specialty certifications. Fifty-eight percent are practicing in a formal CNL role and report a high degree of accountability for all 9 CNL essential competencies. Findings help understand the extent of CNL adoption and spread across the country and the level to which the initial vision of CNL practice is being achieved.

The impact of nurse prescribing on the clinical setting.

PubMed

Creedon, Rena; Byrne, Stephen; Kennedy, Julia; McCarthy, Suzanne

To investigate the impact nurse prescribing has on the organisation, patient and health professional, and to identify factors associated with the growth of nurse prescribing. Systematic search and narrative review. Data obtained through CINAHL, PubMed, Science direct, Online Computer Library Centre (OCLC), databases/websites, and hand searching. English peer-reviewed quantitative, qualitative and mixed-method articles published from September 2009 through to August 2014 exploring nurse prescribing from the perspective of the organisation, health professional and patient were included. Following a systematic selection process, studies identified were also assessed for quality by applying Cardwell's framework. From the initial 443 citations 37 studies were included in the review. Most studies were descriptive in nature. Commonalities addressed were stakeholders' views, prescribing in practice, jurisdiction, education and benefits/barriers. Prescriptive authority for nurses continues to be a positive addition to clinical practice. However, concerns have emerged regarding appropriate support, relationships and jurisdictional issues. A more comprehensive understanding of nurse and midwife prescribing workloads is required to capture the true impact and cost-effectiveness of the initiative.

Follow-up of 100 dogs with acute diarrhoea in a primary care practice.

PubMed

Berset-Istratescu, C M; Glardon, O J; Magouras, I; Frey, C F; Gobeli, S; Burgener, I A

2014-01-01

This study aimed to examine the aetiology of acute diarrhoea and the relapse rate in 100 client-owned dogs presented to a first-opinion clinic. History, physical examination, faecal testing and owner questionnaire data were collected at initial presentation (T0) and at either the time of relapse or at a recheck performed within 3 months. All dogs received treatment according to their clinical signs. Of 96 dogs that completed the study, 37 (38.5%) relapsed during the study period, 21 (21.9%) relapsed within 3 months, and 16 others (16.6%) at 3 months to 1 year after initial examination. Dogs that had undergone a change in housing location within 1 month prior to presentation and dogs <1 year old were significantly more likely to have positive parasitological analyses (P=0.02 and P=0.001, respectively). Pica was a risk factor for relapse (P=0.0002). Copyright © 2013 Elsevier Ltd. All rights reserved.

Using the knowledge-to-action framework to guide the timing of dialysis initiation.

PubMed

Sood, Manish M; Manns, Braden; Nesrallah, Gihad

2014-05-01

The optimal time at which to initiate chronic dialysis remains unknown. Using a contemporary knowledge translation approach (the knowledge-to-action framework), a pan-Canadian collaboration (CANN-NET) set out to study the scope of the problem, then develop and disseminate evidence-based guidelines addressing the timing of dialysis initiation. The purpose of this review is to summarize the key findings and describe the planned Canadian knowledge translation strategy for improving knowledge and practices pertaining to the timing dialysis initiation. New research has provided considerable insights regarding the initiation of dialysis. A Canadian cohort study identified significant variation in the estimated glomerular filtration rate level at dialysis initiation, and a survey of providers identified related knowledge gaps that might be amenable to knowledge translation interventions. A recent knowledge synthesis/guideline concluded that early dialysis initiation is costly, and provides no measureable clinical benefits. A systematic knowledge translation intervention including a multifaceted approach may aid in reducing variation in practice and improving the quality of care. Utilizing the knowledge-to-action framework, we identified practice variation and key barriers to the optimal timing for dialysis initiation that may be amenable to knowledge translation strategies.

Methotrexate Dosage Reduction Upon Adalimumab Initiation: Clinical and Ultrasonographic Outcomes from the Randomized Noninferiority MUSICA Trial.

PubMed

Kaeley, Gurjit S; Evangelisto, Amy M; Nishio, Midori J; Goss, Sandra L; Liu, Shufang; Kalabic, Jasmina; Kupper, Hartmut

2016-08-01

To examine the clinical and ultrasonographic (US) outcomes of reducing methotrexate (MTX) dosage upon initiating adalimumab (ADA) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis (RA). MUSICA (NCT01185288) was a double-blind, randomized, parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening. Patients were randomized to high dosage (20 mg/week) or low dosage (7.5 mg/week) MTX; all patients received 40 mg open-label ADA every other week for 24 weeks. The primary endpoint was Week 24 mean 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) to test for noninferiority of low-dosage MTX using a 15% margin. US images were scored using a 10-joint semiquantitative system incorporating OMERACT definitions for pathology, assessing synovial hypertrophy, vascularity, and bony erosions. Rapid improvement in clinical indices was observed in both groups after addition of ADA. The difference in mean DAS28-CRP (0.37, 95% CI 0.07-0.66) comparing low-dosage (4.12, 95% CI 3.88-4.34) versus high-dosage MTX (3.75, 95% CI 3.52-3.97) was statistically significant and non-inferiority was not met. Statistically significant differences were not detected for most clinical, functional, and US outcomes. Pharmacokinetic and safety profiles were similar. In MUSICA, Week 24 mean DAS28-CRP, the primary endpoint, did not meet non-inferiority for the low-dosage MTX group. Although the differences between the 2 MTX dosage groups were small, our study findings did not support routine MTX reduction in MTX inadequate responders initiating ADA.

Association of complementary and alternative medicine use with highly active antiretroviral therapy initiation.

PubMed

Merenstein, Daniel; Yang, Yang; Schneider, Michael F; Goparaju, Lakshmi; Weber, Kathleen; Sharma, Anjali; Levine, Alexandra M; Sharp, Gerald B; Gandhi, Monica; Liu, Chenglong

2008-01-01

To assess whether complementary and alternative medicine (CAM) use is associated with the timing of highly active antiretroviral therapy (HAART) initiation among human immunodeficiency virus (HIV)-infected participants of the Women's Interagency HIV Study. Prospective cohort study between January 1996 and March 2002. Differences in the cumulative incidence of HAART initiation were compared between CAM users and non-CAM users using a logrank test. Cox regression model was used to assess associations of CAM exposures with time to HAART initiation. MAIN OUTCOME AND EXPOSURES: Study outcome was time from January 1996 to initiation of HAART. Primary exposure was use of any CAM modality before January 1996, and secondary exposures included the number and type of CAM modalities used (ingestible CAM medication, body practice, or spiritual healing) during the same period. One thousand thirty-four HIV-infected women contributed a total of 4987 person-visits during follow-up. At any time point, the cumulative incidence of HAART initiation among CAM users was higher than that among non-CAM users. After adjustment for potential confounders, those reporting CAM use were 1.34 times (95% confidence interval: 1.09, 1.64) more likely to initiate HAART than non-CAM users. Female CAM users initiated HAART regimens earlier than non-CAM users. Initiation of HAART is an important clinical marker, but more research is needed to elucidate the role specific CAM modalities play in HIV disease progression.