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…

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.

The core learning objectives education model: an approach to the teaching of core concepts in the clinical clerkship.

PubMed

Rapp, David E; Lyon, Mark B; Orvieto, Marcelo A; Zagaja, Gregory P

2005-10-01

The classical approach to the undergraduate medical clerkship has several limitations, including variability of clinical exposure and method of examination. As a result, the clerkship experience does not ensure exposure to and reinforcement of the fundamental concepts of a given specialty. This article reviews the classic approach to clerkship education within the undergraduate medical education. Specific attention is placed on clinical exposure and clerkship examination. We describe the introduction of the Core Learning Objective (CLO) educational model at the University of Chicago Section of Urology. This model is designed to provide an efficient exposure to and evaluation of core clerkship learning objectives. The CLO model has been successfully initiated, focusing on both technical and clinical skill sets. The proposed model has been introduced with positive initial results and should allow for an efficient approach to the teaching and evaluation of core objectives in clerkship education.

Paraneoplastic limbic encephalitis presenting as acute viral encephalitis.

PubMed

Kararizou, E; Markou, I; Zalonis, I; Gkiatas, K; Triantafyllou, N; Kararizos, G; Likomanos, D; Zambelis, T; Vassilopoulos, D

2005-11-01

To describe a case of limbic encephalitis which initially presented as viral limbic encephalitis and during the clinical evaluation a renal carcinoma was diagnosed. Patient with history of peripheral paresis of right facial nerve, 1 month after symptoms appearance and treatment, developed fever, vomiting, grand mal seizure, decreased level of consciousness, confusion, hallucinations and agitation. The patient initially presented a clinical picture of viral LE. which confirmed by CSF. MRI brain showed areas with pathological intensity signal in the region of limbic system unilateral. During the clinical evaluation a renal carcinoma was discovered and a nephrectomy has been performed. Although PLE typically presents as a chronic or subacute disease, it may be fulminant and clinically indistinguishable from an acute HSVE. This association pose the problem of a possible relation between this two syndromes and the correct diagnosis is very important, because there are effective treatments.

Dose Optimization in TOF-PET/MR Compared to TOF-PET/CT

PubMed Central

Queiroz, Marcelo A.; Delso, Gaspar; Wollenweber, Scott; Deller, Timothy; Zeimpekis, Konstantinos; Huellner, Martin; de Galiza Barbosa, Felipe; von Schulthess, Gustav; Veit-Haibach, Patrick

2015-01-01

Purpose To evaluate the possible activity reduction in FDG-imaging in a Time-of-Flight (TOF) PET/MR, based on cross-evaluation of patient-based NECR (noise equivalent count rate) measurements in PET/CT, cross referencing with phantom-based NECR curves as well as initial evaluation of TOF-PET/MR with reduced activity. Materials and Methods A total of 75 consecutive patients were evaluated in this study. PET/CT imaging was performed on a PET/CT (time-of-flight (TOF) Discovery D 690 PET/CT). Initial PET/MR imaging was performed on a newly available simultaneous TOF-PET/MR (Signa PET/MR). An optimal NECR for diagnostic purposes was defined in clinical patients (NECRP) in PET/CT. Subsequent optimal activity concentration at the acquisition time ([A]0) and target NECR (NECRT) were obtained. These data were used to predict the theoretical FDG activity requirement of the new TOF-PET/MR system. Twenty-five initial patients were acquired with (retrospectively reconstructed) different imaging times equivalent for different activities on the simultaneous PET/MR for the evaluation of clinically realistic FDG-activities. Results The obtained values for NECRP, [A]0 and NECRT were 114.6 (± 14.2) kcps (Kilocounts per second), 4.0 (± 0.7) kBq/mL and 45 kcps, respectively. Evaluating the NECRT together with the phantom curve of the TOF-PET/MR device, the theoretical optimal activity concentration was found to be approximately 1.3 kBq/mL, which represents 35% of the activity concentration required by the TOF-PET/CT. Initial evaluation on patients in the simultaneous TOF-PET/MR shows clinically realistic activities of 1.8 kBq/mL, which represent 44% of the required activity. Conclusion The new TOF-PET/MR device requires significantly less activity to generate PET-images with good-to-excellent image quality, due to improvements in detector geometry and detector technologies. The theoretically achievable dose reduction accounts for up to 65% but cannot be fully translated into clinical routine based on the coils within the FOV and MR-sequences applied at the same time. The clinically realistic reduction in activity is slightly more than 50%. Further studies in a larger number of patients are needed to confirm our findings. PMID:26147919

OPTICAL PRINCIPLES, BIOMECHANICS, AND INITIAL CLINICAL PERFORMANCE OF A DUAL-OPTIC ACCOMMODATING INTRAOCULAR LENS (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)

PubMed Central

McLeod, Stephen D.

2006-01-01

Purpose To design and develop an accommodating intraocular lens (IOL) for endocapsular fixation with extended accommodative range that can be adapted to current standard extracapsular phacoemulsification technique. Methods Ray tracing analysis and lens design; finite element modeling of biomechanical properties; cadaver eye implantation; initial clinical evaluation. Results Ray tracing analysis indicated that a dual-optic design with a high plus-power front optic coupled to an optically compensatory minus posterior optic produced greater change in conjugation power of the eye compared to that produced by axial movement of a single-optic IOL, and that magnification effects were unlikely to account for improved near vision. Finite element modeling indicated that the two optics can be linked by spring-loaded haptics that allow anterior and posterior axial displacement of the front optic in response to changes in ciliary body tone and capsular tension. A dual-optic single-piece foldable silicone lens was constructed based on these principles. Subsequent initial clinical evaluation in 24 human eyes after phacoemulsification for cataract indicated mean 3.22 diopters of accommodation (range, 1 to 5 D) based on defocus curve measurement. Accommodative amplitude evaluation at 1- and 6-month follow-up in all eyes indicated that the accommodative range was maintained and that the lens was well tolerated. Conclusions A dual-optic design increases the accommodative effect of axial optic displacement, with minimal magnification effect. Initial clinical trials suggest that IOLs designed on this principle might provide true pseudophakic accommodation following cataract extraction and lens implantation. PMID:17471355

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.

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…

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.

Patient-reported outcomes to initiate a provider-patient dialog for the management of hip and knee osteoarthritis.

PubMed

Golightly, Yvonne M; Allen, Kelli D; Nyrop, Kirsten A; Nelson, Amanda E; Callahan, Leigh F; Jordan, Joanne M

2015-10-01

Although many treatment guidelines exist for hip and knee osteoarthritis (OA), uptake in clinical practice is typically low. Valid patient-reported outcome measures (PROs) that can be easily used in the clinic could aid implementation and evaluation of treatment recommendations, and the tracking of symptoms and function over time. This project responded to a 2012 Call to Action of the Chronic Osteoarthritis Management Initiative of the United States Bone and Joint Initiative; we aimed to develop a tiered list of recommended PROs that could be feasibly applied in common clinical settings, across four domains of pain, function, fatigue, and sleep. PROs were identified through a focused literature review. Clinicians and researchers with OA expertise evaluated each measure' feasibility for use in routine clinical practice, followed by meaningfulness in assessing OA outcomes. Eligible PROs were categorized by domain and ranked into Tiers One (very brief measures for initial use in clinical settings), Two (brief measures with more in-depth assessment), and Three (most detailed assessment). Total PROs identified were 172 for pain, 160 for function, 55 for fatigue, and 60 for sleep. Of these, 9 pain, 7 function, 7 fatigue, and 8 sleep PROs were ranked into one of three tiers. This three-tiered list of recommended PROs provides a basis for tools to systematically track outcomes, facilitate provider-patient dialog, and guide treatment for hip or knee OA. Research is needed to test the utility and feasibility of systematic implementation of these measures in primary care and specialty clinical settings. Copyright © 2015 Elsevier Inc. All rights reserved.

Transitioning to HIV Pre-Exposure Prophylaxis (PrEP) from Non-Occupational Post-Exposure Prophylaxis (nPEP) in a Comprehensive HIV Prevention Clinic: A Prospective Cohort Study.

PubMed

Siemieniuk, Reed A C; Sivachandran, Nirojini; Murphy, Pauline; Sharp, Andrea; Walach, Christine; Placido, Tania; Bogoch, Isaac I

2015-08-01

The uptake of pre-exposure prophylaxis (PrEP) for HIV prevention remains low. We hypothesized that a high proportion of patients presenting for HIV non-occupational post-exposure prophylaxis (nPEP) would be candidates for PrEP based on current CDC guidelines. Outcomes from a comprehensive HIV Prevention Clinic are described. We evaluated all patients who attended the HIV Prevention Clinic for nPEP between January 1, 2013 and September 30, 2014. Each patient was evaluated for PrEP candidacy based on current CDC-guidelines and subjectively based on physician opinion. Patients were then evaluated for initiation of PrEP if they met guideline suggestions. Demographic, social, and behavioral factors were then analyzed with logistic regression for associations with PrEP candidacy and initiation. 99 individuals who attended the nPEP clinic were evaluated for PrEP. The average age was 32 years (range, 18-62), 83 (84%) were male, of whom 46 (55%) men who had have sex with men (MSM). 31 (31%) met CDC guidelines for PrEP initiation, which had very good agreement with physician recommendation (kappa=0.88, 0.78-0.98). Factors associated with PrEP candidacy included sexual exposure to HIV, prior nPEP use, and lack of drug insurance (p<0.05 for all comparisons). Combining nPEP and PrEP services in a dedicated clinic can lead to identification of PrEP candidates and may facilitate PrEP uptake. Strategies to ensure equitable access of PrEP should be explored such that those without drug coverage may also benefit from this effective HIV prevention modality.

A Survey on Clinical Research Training Status and Needs in Public Hospitals from Shenzhen

ERIC Educational Resources Information Center

Ji, Ping; Wang, Haibo; Zhang, Chao; Liu, Min; Zhou, Liping; Xiao, Ping; Wang, Yanfang; Wu, Yangfeng

2017-01-01

Objective: To obtain information on the current clinical research training status and evaluate the training needs comprehensively for medical staff in hospitals. Methods: This survey was initiated and conducted by the Health and Family Planning Commission of Shenzhen in conjunction with the Peking University Clinical Research Institute (Shenzhen)…

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.

Is atypical squamous cells that cannot exclude high-grade squamous intraepithelial lesion clinically significant?

PubMed

McHale, Michael T; Souther, Jessica; Elkas, John C; Monk, Bradley J; Harrison, Terry A

2007-04-01

To determine the cumulative risk of cervical intraepithelial neoplasia (CIN) 2 or 3 in patients with atypical squamous cells, cannot exclude HSIL (ASC-H). A retrospective analysis was performed to identify patients referred to the dysplasia clinic with ASC-H. Initial evaluation included colposcopy, endocervical curettage, and an ectocervical biopsy, when indicated, in all the patients. A follow-up evaluation was performed at 6 and 12 months. Cumulative histological diagnosis of CIN 2 or 3 at 12 months served as the clinical end point. Two hundred twenty-nine patients with ASC-H and with a mean age of 32.8 years were evaluated. At the time of initial colposcopy, only 10.0% (23/229; 95% CI = 6.5%-15%) of the patients had histological evidence of CIN 2 or 3. The cumulative risk of CIN 2 or 3 was 12.2% (95% CI = 8%-17%). Evaluation of patients with ASC-H with colposcopy does lead to the detection of CIN 2 or 3 but perhaps at a rate lower than previously reported.

Alzheimer’s Prevention Initiative: a proposal to evaluate presymptomatic treatments as quickly as possible

PubMed Central

Reiman, Eric M; Langbaum, Jessica BS; Tariot, Pierre N

2010-01-01

Now is the time to launch the era of Alzheimer’s disease (AD) prevention research, establish the methods and infrastructure to rapidly evaluate presymptomatic AD treatments and evaluate them rigorously and rapidly in randomized clinical trials. This article is a call to arms. It contends that the evaluation of presymptomatic AD treatments must become an urgent priority, it identifies what is holding us back and proposes new public policies and scientific strategies to overcome these roadblocks. It defines the term ‘presymptomatic AD treatment,’ notes the best established biomarkers of AD progression and pathology and suggests how they could be used to rapidly evaluate presymptomatic AD treatments in the people at risk. It introduces an approach to evaluate presymptomatic AD treatments in asymptomatic people at the highest risk of imminent clinical onset and determines the extent to which the treatment’s biomarker predicts a clinical outcome. We propose an Alzheimer’s Prevention Initiative, which is now being reviewed and refined in partnership with leading academic and industry investigators. It is intended to evaluate the most promising presymptomatic AD treatments, help develop a regulatory pathway for their accelerated approval using reasonably likely surrogate end points and find demonstrably effective presymptomatic AD treatments as quickly as possible. PMID:20383319

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.

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.

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.

Nurses' evaluation of physicians' non-clinical performance in emergency departments: advantages, disadvantages and lessons learned.

PubMed

Alameddine, Mohamad; Mufarrij, Afif; Saliba, Miriam; Mourad, Yara; Jabbour, Rima; Hitti, Eveline

2015-02-27

Peer evaluation is increasingly used as a method to assess physicians' interpersonal and communication skills. We report on experience with soliciting registered nurses' feedback on physicians' non-clinical performance in the ED of a large academic medical center in Lebanon. We utilized a secondary analysis of a de-identified database of ED nurses' assessment of physicians' non-clinical performance coupled with an evaluation of interventions carried out as a result of this evaluation. The database was compiled as part of quality/performance improvement initiatives using a cross-sectional design to survey registered nurses working at the ED. The survey instrument included open ended and closed ended questions assessing physicians' communication, professionalism and leadership skills. Three episodes of evaluation were carried out over an 18 month period. Physicians were provided with a communication training carried out after the first cycle of evaluation and a detailed feedback on their assessment by nurses after each evaluation cycle. A paired t-test was carried out to compare mean evaluation scores between the three cycles of evaluation. Thematic analysis of nurses' qualitative comments was carried out. A statistically significant increase in the averages of skills was observed between the first and second evaluations, followed by a significant decrease in the averages of the three skills between the second and third evaluations. Personalized feedback to ED physicians and communication training initially contributed to a significant positive impact on improving ED physicians' non-clinical skills as perceived by the ED nurses. Yet, gains achieved were lost upon reaching the third cycle of evaluation. However, the thematic analysis of the nurses' qualitative responses portrays a decrease in concerns across the various dimensions of non-clinical performance. Nurses' evaluation of the non-clinical performance of physicians has the potential of improving communication, professionalism and leadership skills amongst physicians. For improvement to be realized in a sustainable manner, such programs may need to be offered in a staged and incremental manner over a long period of time with proper dedication of resources and timely monitoring and evaluation of outcomes. Department directors need to be trained on providing peer evaluation feedback in a constructive manner.

Pediatric Cardiovascular Clinical Trials: An Analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database

PubMed Central

Hill, Kevin D.; Henderson, Heather T.; Hornik, Christoph P.; Li, Jennifer S.

2015-01-01

Recent regulatory initiatives in the United States and Europe have transformed the pediatric clinical trials landscape by significantly increasing capital investment and pediatric trial volume. The purpose of this manuscript is to review the impact of these initiatives on the pediatric cardiovascular trials landscape when compared to other pediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major pediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field. PMID:26377725

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

PubMed

Hill, Kevin D; Henderson, Heather T; Hornik, Christoph P; Li, Jennifer S

2015-08-01

Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.

Evaluation of an Intervention Providing HPV Vaccine in Schools

PubMed Central

Stubbs, Brenda W.; Panozzo, Catherine A.; Moss, Jennifer L.; Reiter, Paul L.; Whitesell, Dianne H.; Brewer, Noel T.

2014-01-01

Objectives To conduct outcome and process evaluations of school-located HPV vaccination clinics in partnership with a local health department. Methods Temporary clinics provided the HPV vaccine to middle school girls in Guilford County, North Carolina, in 2009–2010. Results HPV vaccine initiation was higher among girls attending host schools than satellite schools (6% vs. 1%, OR = 6.56, CI = 3.99–10.78). Of the girls who initiated HPV vaccine, 80% received all 3 doses. Private insurance or federal programs paid for most vaccine doses. Conclusions Lessons learned for creating more effective school-health department partnerships include focusing on host schools and delivering several vaccines to adolescents, not just HPV vaccine alone. PMID:24034684

Supporting and activating clinical governance development in Ireland: sharing our learning.

PubMed

Flynn, Maureen A; Burgess, Thora; Crowley, Philip

2015-01-01

The purpose of this paper is to present a description of the Irish national clinical governance development initiative and an evaluation of the initiative with the purpose of sharing the learning and proposing actions to activate structures and processes for quality and safety. The Quality and Patient Safety Division of the Health Service Executive established the initiative to counterbalance a possible focus on finances during the economic crisis in Ireland and bring attention to the quality of clinical care. A clinical governance framework for quality in healthcare in Ireland was developed to clearly articulate the fundamentals of clinical governance. The project plan involved three overlapping phases. The first was designing resources for practice; the second testing the implementation of the national resources in practice; and the third phase focused on gathering feedback and learning. Staff responded positively to the clinical governance framework. At a time when there are a lot of demands (measurement and scrutiny) the health services leads and responds well to focused support as they improve the quality and safety of services. Promoting the use of the term "governance for quality and safety" assisted in gaining an understanding of the more traditional term "clinical governance". The experience and outcome of the initiative informed the identification of 12 key learning points and a series of recommendations The initial evaluation was conducted at 24 months so at this stage it is not possible to assess the broader impact of the clinical governance framework beyond the action project hospitals. The single most important obligation for any health system is patient safety and improving the quality of care. The easily accessible, practical resources assisted project teams to lead changes in structures and processes within their services. This paper describes the fundamentals of the clinical governance framework which might serve as a guide for more integrative research endeavours on governance for quality and safety. Experience was gained in both the development of national guidance and their practical use in targeted action projects activating structures and processes that are a prerequisite to delivering safe quality services.

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.

Evaluation of the accuracy and clinical practicality of a calculation system for patient positional displacement in carbon ion radiotherapy at five sites.

PubMed

Kubota, Yoshiki; Hayashi, Hayato; Abe, Satoshi; Souda, Saki; Okada, Ryosuke; Ishii, Takayoshi; Tashiro, Mutsumi; Torikoshi, Masami; Kanai, Tatsuaki; Ohno, Tatsuya; Nakano, Takashi

2018-03-01

We developed a system for calculating patient positional displacement between digital radiography images (DRs) and digitally reconstructed radiography images (DRRs) to reduce patient radiation exposure, minimize individual differences between radiological technologists in patient positioning, and decrease positioning time. The accuracy of this system at five sites was evaluated with clinical data from cancer patients. The dependence of calculation accuracy on the size of the region of interest (ROI) and initial position was evaluated for clinical use. For a preliminary verification, treatment planning and positioning data from eight setup patterns using a head and neck phantom were evaluated. Following this, data from 50 patients with prostate, lung, head and neck, liver, or pancreatic cancer (n = 10 each) were evaluated. Root mean square errors (RMSEs) between the results calculated by our system and the reference positions were assessed. The reference positions were manually determined by two radiological technologists to best-matching positions with orthogonal DRs and DRRs in six axial directions. The ROI size dependence was evaluated by comparing RMSEs for three different ROI sizes. Additionally, dependence on initial position parameters was evaluated by comparing RMSEs for four position patterns. For the phantom study, the average (± standard deviation) translation error was 0.17 ± 0.05, rotation error was 0.17 ± 0.07, and ΔD was 0.14 ± 0.05. Using the optimal ROI size for each patient site, all cases of prostate, lung, and head and neck cancer with initial position parameters of 10 mm or under were acceptable in our tolerance. However, only four liver cancer cases and three pancreatic cancer cases were acceptable, because of low-reproducibility regions in the ROIs. Our system has clinical practicality for prostate, lung, and head and neck cancer cases. Additionally, our findings suggest ROI size dependence in some cases. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Evaluation and Sustainability of the Healthy Learners Asthma Initiative

ERIC Educational Resources Information Center

Splett, Patricia L.; Erickson, Cecelia D.; Belseth, Stephanie B.; Jensen, Charlotte

2006-01-01

The Healthy Learners Asthma Initiative (HLAI) involved collaboration between Minneapolis Public Schools (MPS), local health care providers/payors, parents, and other partners. The intervention included development of enhanced asthma care in school health offices and clinic performance improvement projects to foster adoption of National Institutes…

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.

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.

Program development and defining characteristics of returning military in a VA Polytrauma Network Site.

PubMed

Lew, Henry L; Poole, John H; Vanderploeg, Rodney D; Goodrich, Gregory L; Dekelboum, Sharon; Guillory, Sylvia B; Sigford, Barbara; Cifu, David X

2007-01-01

The conflicts in Iraq and Afghanistan have resulted in a new generation of combat survivors with complex physical injuries and emotional trauma. This article reports the initial implementation of the Polytrauma Network Site (PNS) clinic, which is a key component of the Department of Veterans Affairs (VA) Polytrauma System of Care and serves military personnel returning from combat. The PNS clinic in Palo Alto, California, is described to demonstrate the VA healthcare system's evolving effort to meet the clinical needs of this population. We summarize the following features of this interdisciplinary program: (1) sequential assessment, from initial traumatic brain injury screening throughout our catchment area to evaluation by the PNS clinic team, and (2) clinical evaluation results for the first 62 clinic patients. In summary, this population shows a high prevalence of postconcussion symptoms, posttraumatic stress, poor cognitive performance, head and back pain, auditory and visual symptoms, and problems with dizziness or balance. An anonymous patient feedback survey, which we used to fine-tune the clinic process, reflected high satisfaction with this new program. We hope that the lessons learned at one site will enhance the identification and treatment of veterans with polytrauma across the country.

Prevalence of HIV Drug Resistance Before and 1 Year After Treatment Initiation in 4 Sites in the Malawi Antiretroviral Treatment Program

PubMed Central

Bennett, Diane; van Oosterhout, Joep J.; Moyo, Kundai; Hosseinipour, Mina; DeVos, Josh; Zhou, Zhiyong; Aberle-Grasse, John; Warne, Thomas R.; Mtika, Clement; Chilima, Ben; Banda, Richard; Pasulani, Olesi; Porter, Carol; Phiri, Sam; Jahn, Andreas; Kamwendo, Debbie; Jordan, Michael R.; Kabuluzi, Storn; Chimbwandira, Frank; Kagoli, Mathew; Matatiyo, Blackson; Demby, Austin; Yang, Chunfu

2012-01-01

Since 2004, the Malawi antiretroviral treatment (ART) program has provided a public health–focused system based on World Health Organization clinical staging, standardized first-line ART regimens, limited laboratory monitoring, and no patient-level monitoring of human immunodeficiency virus drug resistance (HIVDR). The Malawi Ministry of Health conducts periodic evaluations of HIVDR development in prospective cohorts at sentinel clinics. We evaluated viral load suppression, HIVDR, and factors associated with HIVDR in 4 ART sites at 12–15 months after ART initiation. More than 70% of patients initiating ART had viral suppression at 12 months. HIVDR prevalence (6.1%) after 12 months of ART was low and largely associated with baseline HIVDR. Better follow-up, removal of barriers to on-time drug pickups, and adherence education for patients 16–24 years of age may further prevent HIVDR. PMID:22544204

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.…

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.

Effectiveness of a five-step method for teaching clinical skills to students in a dental college in India.

PubMed

Virdi, Mandeep S; Sood, Meenakshi

2011-11-01

This study conducted at the PDM Dental College and Research Institute, Haryana, India, had the purpose of developing a teaching method based upon a five-step method for teaching clinical skills to students proposed by the American College of Surgeons. This five-step teaching method was used to place fissure sealants as an initial procedure by dental students in clinics. The sealant retention was used as an objective evaluation of the skill learnt by the students. The sealant retention was 92 percent at six- and twelve-month evaluations and 90 percent at the eighteen-month evaluation. These results indicate that simple methods can be devised for teaching clinical skills and achieve high success rates in clinical procedures requiring multiple steps.

2006 Bethesda International Consensus recommendations on the immunophenotypic analysis of hematolymphoid neoplasia by flow cytometry: optimal reagents and reporting for the flow cytometric diagnosis of hematopoietic neoplasia.

PubMed

Wood, Brent L; Arroz, Maria; Barnett, David; DiGiuseppe, Joseph; Greig, Bruce; Kussick, Steven J; Oldaker, Teri; Shenkin, Mark; Stone, Elizabeth; Wallace, Paul

2007-01-01

Immunophenotyping by flow cytometry has become standard practice in the evaluation and monitoring of patients with hematopoietic neoplasia. However, despite its widespread use, considerable variability continues to exist in the reagents used for evaluation and the format in which results are reported. As part of the 2006 Bethesda Consensus conference, a committee was formed to attempt to define a consensus set of reagents suitable for general use in the diagnosis and monitoring of hematopoietic neoplasms. The committee included laboratory professionals from private, public, and university hospitals as well as large reference laboratories that routinely operate clinical flow cytometry laboratories with an emphasis on lymphoma and leukemia immunophenotyping. A survey of participants successfully identified the cell lineage(s) to be evaluated for each of a variety of specific medical indications and defined a set of consensus reagents suitable for the initial evaluation of each cell lineage. Elements to be included in the reporting of clinical flow cytometric results for leukemia and lymphoma evaluation were also refined and are comprehensively listed. The 2006 Bethesda Consensus conference represents the first successful attempt to define a set of consensus reagents suitable for the initial evaluation of hematopoietic neoplasia. Copyright 2007 Clinical Cytometry Society.

European Vaccine Initiative: lessons from developing malaria vaccines.

PubMed

Geels, Mark J; Imoukhuede, Egeruan B; Imbault, Nathalie; van Schooten, Harry; McWade, Terry; Troye-Blomberg, Marita; Dobbelaer, Roland; Craig, Alister G; Leroy, Odile

2011-12-01

For over 10 years, the European Vaccine Initiative (EVI; European Malaria Vaccine Initiative until 2009) has contributed to the development of 24 malaria candidate vaccine antigens with 13 vaccine candidates being advanced into Phase I clinical trials, two of which have been transitioned for further clinical development in sub-Saharan Africa. Since its inception the EVI organization has operated as a funding agency, but with a clear service-oriented strategy. The scientific successes and difficulties encountered during these years and how these efforts have led to standardization and harmonization in vaccine development through large-scale European consortia are discussed. In the future, the EVI will remain instrumental in the pharmaceutical and clinical development of vaccines against 'diseases of poverty' with a continued focus on malaria. EVI will continue to focus on funding and managing preclinical evaluation up to Phase I/II clinical trials and strengthening the vaccine-development infrastructure in Europe, albeit with a global orientation.

Mineralocorticoid before glucocorticoid deficiency in a dog with primary hypoadrenocorticism and hypothyroidism.

PubMed

McGonigle, Kathryn M; Randolph, John F; Center, Sharon A; Goldstein, Richard E

2013-01-01

A dog with an unexpected presentation of primary hypoadrenocorticism was evaluated for clinical signs and electrolyte abnormalities characteristic of Addison's disease. Although the initial adrenocorticotropic hormone (ACTH) stimulation test documented serum cortisol concentrations within the reference range, subsequent assessments confirmed hypoaldosteronism. Mineralocorticoid replacement promptly normalized electrolytes and transiently improved clinical illness. Six weeks after initial ACTH stimulation testing, the dog became glucocorticoid deficient. Concurrent primary hypothyroidism was also documented. Hypoaldosteronism preceding hypocortisolemia is a unique presentation of canine Addison's disease.

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.

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.

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

Implementation of an oxygen therapy clinic to manage users of long-term oxygen therapy.

PubMed

Chaney, John C; Jones, Kevin; Grathwohl, Kurt; Olivier, Kenneth N

2002-11-01

To evaluate the initial benefits of establishing an oxygen therapy clinic (OTC) to manage users of long-term oxygen therapy (LTOT). Cross-sectional observational study. Military-affiliated, tertiary care hospital. Current users of LTOT at our institution and patients with new oxygen prescriptions between June 2000 and May 2001. The OTC evaluation consisted of a focused medical interview and physical examination by a respiratory therapist. Demographic data, indications for supplemental oxygen, oxygen-related diagnoses, cardiopulmonary review of systems, pertinent physical examination findings, pulmonary function testing, and oximetry data were recorded. Patients prescribed oxygen during hospitalization were followed up for recertification within 90 days based on the recommendations of the Fifth Oxygen Consensus Conference. Also, patients with existing oxygen prescriptions and new oxygen prescriptions during the study period were evaluated in the OTC. Data are provided for the initial evaluation in this clinic. A total of 283 patients were evaluated in the OTC during the study period. Ninety-seven patients with a new oxygen prescription during hospitalization were evaluated, with a mean +/- SE time from discharge to evaluation of 2.6 +/- 0.4 months. At follow-up, 50.5% of these patients no longer met Medicare guidelines for LTOT. A significant change in oxygen prescription was required in 27.9% of these patients. A total of 95 outpatients with existing oxygen prescriptions were contacted for recertification in the OTC. Of these patients, 31.6% no longer met Medicare criteria for LTOT and 26% required a significant change to their oxygen prescription. Oxygen therapy was discontinued in 22% of the 91 patients who were referred from other outpatient clinics, and the oxygen prescription was changed in another 29.7%. Results of this initial evaluation suggest that the institution of a respiratory therapist-managed OTC to manage home oxygen patients can significantly decrease inappropriate supplemental oxygen use, which can result in significant cost savings while providing improved health-care delivery. Further evaluation is necessary to identify the long-term benefits and cost savings in this population.

Cost-benefit analysis of biopsy methods for suspicious mammographic lesions; discussion 994-5.

PubMed

Fahy, B N; Bold, R J; Schneider, P D; Khatri, V; Goodnight, J E

2001-09-01

Stereotactic core biopsy (SCB) is more cost-effective than needle-localized biopsy (NLB) for evaluation and treatment of mammographic lesions. A computer-generated mathematical model was developed based on clinical outcome modeling to estimate costs accrued during evaluation and treatment of suspicious mammographic lesions. Total costs were determined for evaluation and subsequent treatment of cancer when either SCB or NLB was used as the initial biopsy method. Cost was estimated by the cumulative work relative value units accrued. The risk of malignancy based on the Breast Imaging Reporting Data System (BIRADS) score and mammographic suspicion of ductal carcinoma in situ were varied to simulate common clinical scenarios. Total cost accumulated during evaluation and subsequent surgical therapy (if required). Evaluation of BIRADS 5 lesions (highly suggestive, risk of malignancy = 90%) resulted in equivalent relative value units for both techniques (SCB, 15.54; NLB, 15.47). Evaluation of lesions highly suspicious for ductal carcinoma in situ yielded similar total treatment relative value units (SCB, 11.49; NLB, 10.17). Only for evaluation of BIRADS 4 lesions (suspicious abnormality, risk of malignancy = 34%) was SCB more cost-effective than NLB (SCB, 7.65 vs. NLB, 15.66). No difference in cost-benefit was found when lesions highly suggestive of malignancy (BIRADS 5) or those suspicious for ductal carcinoma in situ were evaluated initially with SCB vs. NLB, thereby disproving the hypothesis. Only for intermediate-risk lesions (BIRADS 4) did initial evaluation with SCB yield a greater cost savings than with NLB.

Design and testing of classroom and clinical teaching evaluation tools for nursing education.

PubMed

Emerson, Roberta J; Records, Kathie

2007-01-01

Student evaluations of teaching provide administrators an overall picture of the effectiveness of personnel and contribute data for promotion and merit decisions. These evaluations must be assessed for their relevance, validity, and reliability. This paper describes the development process and psychometric testing for clinical (n = 149) and didactic (n = 148) student evaluation of teaching forms for undergraduate and graduate courses in one college of nursing. Validity and reliability results were quite strong for the instruments, both of which evidenced a one-factor solution with factor loadings ranging from .68-.88 and Cronbach's alphas of .96 (Classroom) and .95 (Clinical). The clinical and classroom evaluation tools are relatively short, decreasing the burden on students who need to complete the instruments for multiple instructors in any one semester. Initial testing of the psychometric properties of the tools supports their continued use in colleges of nursing.

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.

Clinical and histopathological evaluation of 16 dogs with T-zone lymphoma

PubMed Central

MIZUTANI, Noriyuki; GOTO-KOSHINO, Yuko; TAKAHASHI, Masashi; UCHIDA, Kazuyuki; TSUJIMOTO, Hajime

2016-01-01

Clinical and histopathological characteristics of 16 dogs with nodal paracortical (T-zone) lymphoma (TZL) were evaluated. At initial examination, generalized lymphadenopathy was found in all dogs, and peripheral lymphocytosis was found in 10 of the 16 dogs. At initial diagnosis or during the disease course, 8 dogs (50%) were affected with demodicosis. Immunohistochemical analysis for CD3, CD20 and CD25 was performed for 6 dogs with TZL; the tumor cells were positive for CD3 and CD25 and negative for CD20. Median overall survival time was 938 days. A watchful waiting approach was adopted for 6 cases (38%), and 5 of the 6 dogs were still alive at the end of follow-up. The clinical course of TZL in dogs is generally indolent; however, many cases develop a variety of infectious and other neoplastic diseases after the diagnosis of TZL. PMID:27098109

Does short-term virologic failure translate to clinical events in antiretroviral-naïve patients initiating antiretroviral therapy in clinical practice?

PubMed

Mugavero, Michael J; May, Margaret; Harris, Ross; Saag, Michael S; Costagliola, Dominique; Egger, Matthias; Phillips, Andrew; Günthard, Huldrych F; Dabis, Francois; Hogg, Robert; de Wolf, Frank; Fatkenheuer, Gerd; Gill, M John; Justice, Amy; D'Arminio Monforte, Antonella; Lampe, Fiona; Miró, Jose M; Staszewski, Schlomo; Sterne, Jonathan A C

2008-11-30

To determine whether differences in short-term virologic failure among commonly used antiretroviral therapy (ART) regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART. Observational cohort study of patients initiating ART between January 2000 and December 2005. The Antiretroviral Therapy Cohort Collaboration (ART-CC) is a collaboration of 15 HIV cohort studies from Canada, Europe, and the United States. A total of 13 546 antiretroviral-naïve HIV-positive patients initiating ART with efavirenz, nevirapine, lopinavir/ritonavir, nelfinavir, or abacavir as third drugs in combination with a zidovudine and lamivudine nucleoside reverse transcriptase inhibitor backbone. Short-term (24-week) virologic failure (>500 copies/ml) and clinical events within 2 years of ART initiation (incident AIDS-defining event, death, and a composite measure of these two outcomes). Compared with efavirenz as initial third drug, short-term virologic failure was more common with all other third drugs evaluated; nevirapine (adjusted odds ratio = 1.87, 95% confidence interval (CI) = 1.58-2.22), lopinavir/ritonavir (1.32, 95% CI = 1.12-1.57), nelfinavir (3.20, 95% CI = 2.74-3.74), and abacavir (2.13, 95% CI = 1.82-2.50). However, the rate of clinical events within 2 years of ART initiation appeared higher only with nevirapine (adjusted hazard ratio for composite outcome measure 1.27, 95% CI = 1.04-1.56) and abacavir (1.22, 95% CI = 1.00-1.48). Among antiretroviral-naïve patients initiating therapy, between-ART regimen, differences in short-term virologic failure do not necessarily translate to differences in clinical outcomes. Our results should be interpreted with caution because of the possibility of residual confounding by indication.

Influence of age on clinical outcomes of three-dimensional transfer of the tibial tuberosity for patellar instability with patella alta.

PubMed

Otsuki, Shuhei; Nakajima, Mikio; Fujiwara, Kenta; Okamoto, Yoshinori; Iida, Go; Murakami, Tomohiko; Neo, Masashi

2017-08-01

To evaluate the clinical outcomes of three-dimensional (3D) transfer of the tibial tuberosity for patellar instability with patella alta, with a focus on the influence of age at initial surgery. Three-dimensional surgery was performed on 28 knees with a mean follow-up of 46 months. Patients were separated into three groups based on the age at initial surgery: group A, 10 knees and an average age of 16.3 ± 1.8 (14-19) years; group B, 10 knees and an average age of 22.1 ± 2.5 (20-28) years; and group C, eight knees and an average age of 44.0 ± 2.2 (40-46) years. Patellofemoral geometry improvement focused on patella alta by determining the Insall-Salvati ratio and Caton-Deschamps index, rotational malalignment by measuring the tibial tubercle-trochlear groove (TT-TG) distance, and lateral patellar subluxation by measuring the patellar tilt. Clinical outcomes were evaluated by the Lysholm and Kujala scores, which were compared before and after surgery. Cartilage degeneration was evaluated by the International Cartilage Repair Society grading system at initial arthroscopy. The patellar height, TT-TG, and patellar tilt significantly improved in all groups postoperatively (p < 0.05). The Lysholm and Kujala scores also significantly improved postoperatively; however, both scores were lower in group C than in the other groups (p < 0.05). Particularly, pain scores were more severe in group C than in the other groups, and the severity of cartilage degeneration correlated with the pain scores (p < 0.05). Cartilage damage differed significantly between the groups at initial arthroscopy; particularly, group C included grades III and IV cartilage degeneration (p < 0.05). Age at initial surgery may be the predicting factor for poor clinical outcomes of 3D transfer surgery. The clinical outcome may depend on the age at surgery, which correlated with cartilage damage; thus, surgeons should be given this information when patients are considered undergoing patella surgery. Therapeutic case series, Level IV.

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.

Ethnoracial Differences in the Clinical Characteristics of Alzheimer Disease at Initial Presentation at an Urban Alzheimer’s Disease Center

PubMed Central

Livney, Melissa Gartenberg; Clark, Christopher M.; Karlawish, Jason H.; Cartmell, Su; Negrón, Mirna; Nuñez-Lopez, Jessica; Xie, Sharon X.; Entenza-Cabrera, Fernando; Vega, Irving E.; Arnold, Steven E.

2010-01-01

Objective To compare presentation of Alzheimer disease (AD) at the time of initial evaluation at a university specialty clinic across three ethnoracial groups in order to understand similarities and differences in the demographic, clinical, cognitive, psychiatric, and biologic features. Design Cross-sectional study. Participants A total of 1,341 self-identified African American, Latino (primarily of Caribbean origin), and white non-Hispanic (“WNH”) subjects were recruited from primary care sites or by referral by primary care physicians. Measurements Demographic variables and age of onset of AD, as well as cognitive, functional, and mood impairments at the time of initial presentation and frequencies of apolipoprotein E genotypes, were compared across groups. Results Differences among ethnoracial groups were found for nearly all variables of interest. In particular, the largely immigrant Puerto Rican Latino group had an earlier age of onset of AD, more cognitive impairment, and greater severity of cognitive impairment at the time of initial evaluation in the setting of low average education and socioeconomic status. There was more depression in the Latinos compared with African Americans and WNHs. Greater severity of symptoms was not accounted for by a difference in lag time between onset of symptoms and initial evaluation. The apolipoprotein E-4 genotype was not associated with AD in the Latino cohort. Conclusions Minority groups in Philadelphia, especially Latinos, exhibit a more severe profile of AD at the time of presentation than WNHs. Important potential confounds need to be considered and future research comparing immigrant and nonimmigrant Latino groups will be necessary to elucidate the highly significant differences reported. PMID:21522051

Spurious testosterone laboratory results in a patient taking synthetic alkaline phosphatase (asfotase alfa).

PubMed

Sofronescu, Alina G; Ross, Meredith; Rush, Eric; Goldner, Whitney

2018-04-27

We report a case of discordant total and free testosterone values in a patient with hypogonadism and juvenile hypophosphatasia after he initiated treatment with asfotase alfa, recombinant tissue non-specific alkaline phosphatase. Total testosterone was evaluated using immunoassay pre and post initiation of therapy with asfotase alfa, and free testosterone was evaluated using radioimmunoassay and LC-MS/MS while on asfotase alfa therapy. Total testosterone measured by immunoassay was normal prior to therapy with asfotase alfa, and was low post initiation of therapy. During the same time frame, free testosterone measured using RAI and total testosterone measured using LC-MS/MS were normal on asfotase alfa therapy. This suggests assay interference with the total testosterone immunoassay. When laboratory results are discordant or do not match the clinical impression, the possibility of assay interference should be considered. Alternative laboratory methods free of the interference should be selected to evaluate these patients. ALPL gene, Approved name: Alkaline phosphatase, liver/bone/kidney, Synonym: Tissue non-specific alkaline phosphatase (TNSAP). Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

High-fidelity hybrid simulation of allergic emergencies demonstrates improved preparedness for office emergencies in pediatric allergy clinics.

PubMed

Kennedy, Joshua L; Jones, Stacie M; Porter, Nicholas; White, Marjorie L; Gephardt, Grace; Hill, Travis; Cantrell, Mary; Nick, Todd G; Melguizo, Maria; Smith, Chris; Boateng, Beatrice A; Perry, Tamara T; Scurlock, Amy M; Thompson, Tonya M

2013-01-01

Simulation models that used high-fidelity mannequins have shown promise in medical education, particularly for cases in which the event is uncommon. Allergy physicians encounter emergencies in their offices, and these can be the source of much trepidation. To determine if case-based simulations with high-fidelity mannequins are effective in teaching and retention of emergency management team skills. Allergy clinics were invited to Arkansas Children's Hospital Pediatric Understanding and Learning through Simulation Education center for a 1-day workshop to evaluate skills concerning the management of allergic emergencies. A Clinical Emergency Preparedness Team Performance Evaluation was developed to evaluate the competence of teams in several areas: leadership and/or role clarity, closed-loop communication, team support, situational awareness, and scenario-specific skills. Four cases, which focus on common allergic emergencies, were simulated by using high-fidelity mannequins and standardized patients. Teams were evaluated by multiple reviewers by using video recording and standardized scoring. Ten to 12 months after initial training, an unannounced in situ case was performed to determine retention of the skills training. Clinics showed significant improvements for role clarity, teamwork, situational awareness, and scenario-specific skills during the 1-day workshop (all P < .003). Follow-up in situ scenarios 10-12 months later demonstrated retention of skills training at both clinics (all P ≤ .004). Clinical Emergency Preparedness Team Performance Evaluation scores demonstrated improved team management skills with simulation training in office emergencies. Significant recall of team emergency management skills was demonstrated months after the initial training. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Registry Assessment of Peripheral Interventional Devices (RAPID)　- Registry Assessment of Peripheral Interventional Devices Core Data Elements.

PubMed

Jones, W Schuyler; Krucoff, Mitchell W; Morales, Pablo; Wilgus, Rebecca W; Heath, Anne H; Williams, Mary F; Tcheng, James E; Marinac-Dabic, J Danica; Malone, Misti L; Reed, Terrie L; Fukaya, Rie; Lookstein, Robert; Handa, Nobuhiro; Aronow, Herbert D; Bertges, Daniel J; Jaff, Michael R; Tsai, Thomas T; Smale, Joshua A; Zaugg, Margo J; Thatcher, Robert J; Cronenwett, Jack L; Nc, Durham; Md, Silver Spring; Japan, Tokyo; Ny, New York; Ri, Providence; Vt, Burlington; Mass, Newton; Colo, Denver; Ariz, Tempe; Calif, Santa Clara; Minn, Minneapolis; Nh, Lebanon

2018-01-25

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Syncope Best Practices: A Syncope Clinical Practice Guideline to Improve Quality.

PubMed

Phelps, Heather M; Sachdeva, Ritu; Mahle, William T; McCracken, Courtney E; Kelleman, Michael; McConnell, Michael; Fischbach, Peter S; Cardis, Brian M; Campbell, Robert M; Oster, Matthew E

2016-05-01

To determine whether implementation of a standardized clinical practice guideline (CPG) for the evaluation of syncope would decrease practice variability and resource utilization. A retrospective review of medical records of patients presenting to our practice for outpatient evaluation of syncope before and after implementation of the CPG. The guideline included elements of history, physical exam, electrocardiogram, and "red flags" for further testing. Outpatient pediatric cardiology offices of a large pediatric cardiology practice. All new patients between 3 and 21 years old, who presented to cardiology clinic with a chief complaint of syncope. The CPG for the evaluation of pediatric syncope was presented to the providers. Resource utilization was determined by the tests ordered by individual physicians before and after initiation of the CPG. Patient final diagnoses were recorded and the medical records were subsequently reviewed to determine if any patients, who presented again to the system, were ultimately diagnosed with cardiac disease. Of the 1496 patients with an initial visit for syncope, there was no significant difference in the diagnosis of cardiac disease before or after initiation of the CPG: (0.6% vs. 0.4%, P = .55). Electrocardiography provides the highest yield in the evaluation of pediatric syncope. Despite high compliance (86.9%), there were no overall changes in costs ($346.31 vs. $348.53, P = .85) or in resource utilization. There was, however, a decrease in the variability of ordering of echocardiograms among physicians, particularly among those at the extremes of utilization. Although the CPG did not decrease already low costs, it did decrease the wide variability in echo utilization. Evaluation beyond detailed history, physical exam, and electrocardiography provides no additional benefit in the evaluations of pediatric patients presenting with syncope. © 2015 Wiley Periodicals, Inc.

Initiating an ophthalmic laser program for VA outpatients.

PubMed

Newcomb, R D

1995-08-01

Administrative and clinical considerations for the establishment of an ophthalmic laser program at a VA Outpatient Clinic are discussed. Outcomes of the first 320 patients treated over a 3-year period of time are presented. The program is evaluated from the perspectives of patient care, safety, maintenance, education, and economics.

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

Nutrition in medical education: reflections from an initiative at the University of Cambridge

PubMed Central

Ball, Lauren; Crowley, Jennifer; Laur, Celia; Rajput-Ray, Minha; Gillam, Stephen; Ray, Sumantra

2014-01-01

Landmark reports have confirmed that it is within the core responsibilities of doctors to address nutrition in patient care. There are ongoing concerns that doctors receive insufficient nutrition education during medical training. This paper provides an overview of a medical nutrition education initiative at the University of Cambridge, School of Clinical Medicine, including 1) the approach to medical nutrition education, 2) evaluation of the medical nutrition education initiative, and 3) areas identified for future improvement. The initiative utilizes a vertical, spiral approach during the clinically focused years of the Cambridge undergraduate and graduate medical degrees. It is facilitated by the Nutrition Education Review Group, a group associated with the UK Need for Nutrition Education/Innovation Programme, and informed by the experiences of their previous nutrition education interventions. Three factors were identified as contributing to the success of the nutrition education initiative including the leadership and advocacy skills of the nutrition academic team, the variety of teaching modes, and the multidisciplinary approach to teaching. Opportunities for continuing improvement to the medical nutrition education initiative included a review of evaluation tools, inclusion of nutrition in assessment items, and further alignment of the Cambridge curriculum with the recommended UK medical nutrition education curriculum. This paper is intended to inform other institutions in ongoing efforts in medical nutrition education. PMID:24899813

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.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

Evaluating faculty clinical excellence in the academic health sciences center.

PubMed

Carey, R M; Wheby, M S; Reynolds, R E

1993-11-01

Although excellence in the clinical care of patients is the cornerstone of medicine, academic health sciences centers have increasingly given more weight to research and correspondingly less emphasis to patient care. To better recognize and reward clinical excellence, it is first necessary to effectively evaluate physicians' performances in patient care. In addition to addressing the value of faculty clinical excellence in the academic setting, the authors discuss different approaches to clinical assessment, theoretical and practical problems in assessing the performances of clinical faculty, and a system of evaluation being initiated at the University of Virginia School of Medicine. This system of evaluation combines--in annual individual reviews--a limited amount of objective assessment data with subjective evaluations from several sources. The objective data include board certification and recertification, analysis of outcomes data, and documentation of scholarly activity. The subjective evaluations include letters of recognition and appreciation from faculty colleagues and written observations from department chairs, housestaff, students, and nurses. The system has been accepted by department chairs, members of the Promotion and Tenure Committee, and the general faculty. In implementing this new system, periodic review of the pace and direction of change will be crucial to track progress and provide feedback for further modification.

An Evaluation of Preference for Mode of Instruction Following Variations in Response Effort

ERIC Educational Resources Information Center

Romani, Patrick W.; McCoy, Thomasin E.; Wacker, David P.; Padilla-Dalmau, Yaniz C.

2014-01-01

The current study evaluated preference for mode of instruction (i.e., visual or vocal) for four children diagnosed with a language-based learning disability. Each participant was an elementary student who was initially referred to a neuropsychology clinic specializing in learning disabilities. As a part of the evaluation, measures of each…

Mapping mental health service access: achieving equity through quality improvement.

PubMed

Green, Stuart A; Poots, Alan J; Marcano-Belisario, Jose; Samarasundera, Edgar; Green, John; Honeybourne, Emmi; Barnes, Ruth

2013-06-01

Improving access to psychological therapies (IAPTs) services deliver evidence-based care to people with depression and anxiety. A quality improvement (QI) initiative was undertaken by an IAPT service to improve referrals providing an opportunity to evaluate equitable access. QI methodologies were used by the clinical team to improve referrals to the service. The collection of geo-coded data allowed referrals to be mapped to small geographical areas according to deprivation. A total of 6078 patients were referred to the IAPT service during the period of analysis and mapped to 120 unique lower super output areas (LSOAs). The average weekly referral rate rose from 17 during the baseline phase to 43 during the QI implementation phase. Spatial analysis demonstrated all 15 of the high deprivation/low referral LSOAs were converted to high deprivation/high or medium referral LSOAs following the QI initiative. This work highlights the importance of QI in developing clinical services aligned to the needs of the population through the analysis of routine data matched to health needs. Mapping can be utilized to communicate complex information to inform the planning and organization of clinical service delivery and evaluate the progress and sustainability of QI initiatives.

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

Statistical controversies in clinical research: an initial evaluation of a surrogate end point using a single randomized clinical trial and the Prentice criteria

PubMed Central

Heller, G.

2015-01-01

Surrogate end point research has grown in recent years with the increasing development and usage of biomarkers in clinical research. Surrogacy analysis is derived through randomized clinical trial data and it is carried out at the individual level and at the trial level. A common surrogate analysis at the individual level is the application of the Prentice criteria. An approach for the evaluation of the Prentice criteria is discussed, with a focus on its most difficult component, the determination of whether the treatment effect is captured by the surrogate. An interpretation of this criterion is illustrated using data from a randomized clinical trial in prostate cancer. PMID:26254442

Supervising and Supporting Student Nurses in Clinical Placements: The Peer Support Initiative.

ERIC Educational Resources Information Center

Aston, Liz; Molassiotis, Alexander

2003-01-01

A program in which senior nursing students (n=31) supported junior students (n=27) in clinical placements was evaluated. Peer support was considered valuable, but both groups desired more preparation for their roles. Seniors felt their teaching and mentoring skills were enhanced. Juniors reduced anxiety about placements. (Contains 26 references.)…

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...

DIAGNOSIS AND SUCCESSFUL TREATMENT OF A POTENTIALLY ZOONOTIC DERMATOPHYTOSIS CAUSED BY MICROSPORUM GYPSEUM IN A ZOO-HOUSED NORTH AMERICAN PORCUPINE (ERETHIZON DORSATUM).

PubMed

Hackworth, Christine E; Eshar, David; Nau, Melissa; Bagladi-Swanson, Mary; Andrews, Gordon A; Carpenter, James W

2017-06-01

A female North American porcupine ( Erethizon dorsatum ) was evaluated for a unilateral pedal crusting and alopecic dermatopathy. Fungal culture and histopathology testing revealed Microsporum gypseum dermatophytosis. Treatment with topical miconazole was initiated and then discontinued after 9 days and changed to oral terbinafine. Twenty-eight days after initial examination, clinical signs were improving, and fungal cultures of the front foot, muzzle, and noninfected area along the dorsum were negative for M. gypseum. Visual exams were conducted on a regular basis. Eighty-three days after initial evaluation, clinical signs had completely resolved and repeat fungal cultures were negative. One of the animal's keepers was suspected to have acquired a dermal fungal infection 3 days after contact with this porcupine, and lesions had resolved after treatment with topical ketoconazole. To the authors' knowledge, this is the first report of M. gypseum diagnosed and treated in a captive North American porcupine. Veterinary staff and zookeepers should be aware of this potentially zoonotic infection.

Implementation of Electronic Checklists in an Oncology Medical Record: Initial Clinical Experience

PubMed Central

Albuquerque, Kevin V.; Miller, Alexis A.; Roeske, John C.

2011-01-01

Purpose: The quality of any medical treatment depends on the accurate processing of multiple complex components of information, with proper delivery to the patient. This is true for radiation oncology, in which treatment delivery is as complex as a surgical procedure but more dependent on hardware and software technology. Uncorrected errors, even if small or infrequent, can result in catastrophic consequences for the patient. We developed electronic checklists (ECLs) within the oncology electronic medical record (EMR) and evaluated their use and report on our initial clinical experience. Methods: Using the Mosaiq EMR, we developed checklists within the clinical assessment section. These checklists are based on the process flow of information from one group to another within the clinic and enable the processing, confirmation, and documentation of relevant patient information before the delivery of radiation therapy. The clinical use of the ECL was documented by means of a customized report. Results: Use of ECL has reduced the number of times that physicians were called to the treatment unit. In particular, the ECL has ensured that therapists have a better understanding of the treatment plan before the initiation of treatment. An evaluation of ECL compliance showed that, with additional staff training, > 94% of the records were completed. Conclusion: The ECL can be used to ensure standardization of procedures and documentation that the pretreatment checks have been performed before patient treatment. We believe that the implementation of ECLs will improve patient safety and reduce the likelihood of treatment errors. PMID:22043184

Clinical End Points and Response Criteria in Mycosis Fungoides and Sézary Syndrome: A Consensus Statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer

PubMed Central

Olsen, Elise A.; Whittaker, Sean; Kim, Youn H.; Duvic, Madeleine; Prince, H. Miles; Lessin, Stuart R.; Wood, Gary S.; Willemze, Rein; Demierre, Marie-France; Pimpinelli, Nicola; Bernengo, Maria Grazia; Ortiz-Romero, Pablo L.; Bagot, Martine; Estrach, Teresa; Guitart, Joan; Knobler, Robert; Sanches, José Antonio; Iwatsuki, Keiji; Sugaya, Makoto; Dummer, Reinhard; Pittelkow, Mark; Hoppe, Richard; Parker, Sareeta; Geskin, Larisa; Pinter-Brown, Lauren; Girardi, Michael; Burg, Günter; Ranki, Annamari; Vermeer, Maartan; Horwitz, Steven; Heald, Peter; Rosen, Steve; Cerroni, Lorenzo; Dreno, Brigette; Vonderheid, Eric C.

2011-01-01

Mycosis fungoides (MF) and Sézary syndrome (SS), the major forms of cutaneous T-cell lymphoma, have unique characteristics that distinguish them from other types of non-Hodgkin's lymphomas. Clinical trials in MF/SS have suffered from a lack of standardization in evaluation, staging, assessment, end points, and response criteria. Recently defined criteria for the diagnosis of early MF, guidelines for initial evaluation, and revised staging and classification criteria for MF and SS now offer the potential for uniform staging of patients enrolled in clinical trials for MF/SS. This article presents consensus recommendations for the general conduct of clinical trials of patients with MF/SS as well as methods for standardized assessment of potential disease manifestations in skin, lymph nodes, blood, and visceral organs, and definition of end points and response criteria. These guidelines should facilitate collaboration among investigators and collation of data from sponsor-generated or investigator-initiated clinical trials involving patients with MF or SS. PMID:21576639

A digital peer-to-peer learning platform for clinical skills development.

PubMed

Basnak, Jesse; Ortynski, Jennifer; Chow, Meghan; Nzekwu, Emeka

2017-02-01

Due to constraints in time and resources, medical curricula may not provide adequate opportunities for pre-clerkship students to practice clinical skills. To address this, medical students at the University of Alberta developed a digital peer-to-peer learning initiative. The initiative assessed if students can learn clinical skills from their peers in co-curricular practice objective structured clinical exams (OSCEs). A total of 144 first-year medical students participated. Students wrote case scenarios that were reviewed by physicians. Students enacted the cases in practice OSCEs, acting as the patient, physician, and evaluator. Verbal and electronic evaluations were completed. A digital platform was used to automate the process. Surveys were disseminated to assess student perceptions of their experience. Seventy-five percent of participants said they needed opportunities to practice patient histories and physical exams in addition to those provided in the medical school curriculum. All participants agreed that the co-curricular practice OSCEs met this need. The majority of participants also agreed that the digital platform was efficient and easy to use. Students found the practice OSCEs and digital platform effective for learning clinical skills. Thus, peer-to-peer learning and computer automation can be useful adjuncts to traditional medical curricula.

[Spontaneous splenic rupture as complication of infective mononucleosis: a clinical case].

PubMed

Delle Monache, Guido; Orlando, Dante; Frassanito, Salvatore; Sciarra, Roberto; Rinaldi, Manlio Tullio

2003-01-01

Spontaneous splenic rupture is a very rare complication of infectious mononucleosis, already described by other authors. In this case report we show the findings occurring in a young man who presented with sudden left thoracic pain and dyspnea. The initial work-up was oriented towards a suspected diagnosis of left spontaneous pneumothorax. Initially, little attention was paid to the clinical history that was characterized by flu-like symptoms during the previous 2 weeks; this, along with a rushed physical examination, could have had dramatic consequences, due to the unavoidable diagnostic delay. A thorough clinical evaluation by Internists, coupled with the essential ultrasonographic diagnostic support, allowed an earlier diagnosis followed by definitive cure, i.e. splenectomy.

Acute methaemoglobinaemia initially treated as organophosphate poisoning leading to atropine toxicity.

PubMed

Kakhandki, Srinivas; Yahya, Mohammed; Praveen, Mudalgi

2012-07-01

A case of unknown compound poisoning is presented. It was initially treated as organophosphate poisoning with lack of response. A timely diagnosis of acute methaemoglobinaemia and iatrogenic atropine toxicity was made based on clinical evaluation. Treatment of methaemoglobinaemia using oral methylene blue and of atropine toxicity with supportive measures could save the patient.

Precancerous Skin Lesions.

PubMed

Ferrándiz, C; Malvehy, J; Guillén, C; Ferrándiz-Pulido, C; Fernández-Figueras, M

Certain clinically and histologically recognizable skin lesions with a degree of risk of progression to squamous cell carcinoma have been traditionally grouped as precancerous skin conditions but now tend to be classified as in situ carcinomas. This consensus statement discusses various aspects of these lesions: their evaluation by means of clinical and histopathologic features, the initial evaluation of the patient, the identification of risk factors for progression, and the diagnostic and treatment strategies available today. Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

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

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

PubMed

Jones, W Schuyler; Krucoff, Mitchell W; Morales, Pablo; Wilgus, Rebecca W; Heath, Anne H; Williams, Mary F; Tcheng, James E; Marinac-Dabic, J Danica; Malone, Misti L; Reed, Terrie L; Fukaya, Rie; Lookstein, Robert A; Handa, Nobuhiro; Aronow, Herbert D; Bertges, Daniel J; Jaff, Michael R; Tsai, Thomas T; Smale, Joshua A; Zaugg, Margo J; Thatcher, Robert J; Cronenwett, Jack L

2018-02-01

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators. Copyright © 2017 Society for Vascular Surgery. All rights reserved.

The development and initial validation of a clinical tool for patients' preferences on patient participation--The 4Ps.

PubMed

Eldh, Ann Catrine; Luhr, Kristina; Ehnfors, Margareta

2015-12-01

To report on the development and initial testing of a clinical tool, The Patient Preferences for Patient Participation tool (The 4Ps), which will allow patients to depict, prioritize, and evaluate their participation in health care. While patient participation is vital for high quality health care, a common definition incorporating all stakeholders' experience is pending. In order to support participation in health care, a tool for determining patients' preferences on participation is proposed, including opportunities to evaluate participation while considering patient preferences. Exploratory mixed methods studies informed the development of the tool, and descriptive design guided its initial testing. The 4Ps tool was tested with 21 Swedish researcher experts (REs) and patient experts (PEs) with experience of patient participation. Individual Think Aloud interviews were employed to capture experiences of content, response process, and acceptability. 'The 4Ps' included three sections for the patient to depict, prioritize, and evaluate participation using 12 items corresponding to 'Having Dialogue', 'Sharing Knowledge', 'Planning', and 'Managing Self-care'. The REs and PEs considered 'The 4Ps' comprehensible, and that all items corresponded to the concept of patient participation. The tool was perceived to facilitate patient participation whilst requiring amendments to content and layout. A tool like The 4Ps provides opportunities for patients to depict participation, and thus supports communication and collaboration. Further patient evaluation is needed to understand the conditions for patient participation. While The 4Ps is promising, revision and testing in clinical practice is required. © 2014 John Wiley & Sons Ltd.

Severe pulmonary hypertension as the initial manifestation of systemic lupus erythematosus: a case report and review of the literature.

PubMed

Prete, M; Fatone, M C; Vacca, A; Racanelli, V; Perosa, F

2014-01-01

Severe pulmonary arterial hypertension (PAH) is rarely observed as the initial manifestation of systemic lupus erythematosus (SLE), and the diagnosis is often delayed. Here we present the case of a 32-year-old woman with severe PAH as the initial manifestation of SLE, who was successfully treated with mycophenolate mofetil and cyclosporine. This case offered the opportunity to critically review the epidemiology data, predictive markers, and pathogenic pathways of SLE-associated PAH (SLE-PAH) in relation to the currently available therapeutic options and to the main clinical trials of the last 10 years focused on the treatment of SLE-PAH. Mycophenolate mofetil and cyclosporine - currently used in the maintenance phase of the disease in certain clinical settings - should be considered, as an alternative to cyclophosphamide, in future clinical trials aimed at evaluating the most effective treatment of SLE-PAH at presentation.

MYCOBACTERIUM ABSCESSUS PNEUMONIA IN AN ATLANTIC BOTTLENOSE DOLPHIN (TURSIOPS TRUNCATUS)

PubMed Central

Clayton, Leigh Ann; Stamper, M. Andrew; Whitaker, Brent R.; Hadfield, Catherine A.; Simons, Brian; Mankowski, Joseph L.

2013-01-01

Mycobacterium abscessus pneumonia was diagnosed antemortem in a 23-yr-old male Atlantic bottlenose dolphin (Tursiops truncatus). Clinical signs included lethargy, hyporexia, coughing, and bloody respiratory discharge. Diagnostic findings included neutrophilic leukocytosis, anemia, elevated erythrocyte sedimentation rate, and repeated forceful exhaled breath (sputum) cytology, with acute inflammatory cells and acid-fast positive beaded rods. The bacteria were initially identified free in the sputum sample and subsequently were seen within neutrophils. A culture was positive for a rapidly growing, white, colony-forming organism confirmed as M. abscessus by polymerase chain reaction and DNA sequencing. Clinical signs initially resolved with multidrug therapy. Concurrent Pseudomonas aeruginosa infection complicated clinical management and contributed to terminal decline. The dolphin was euthanized 5 mo after initial diagnosis. Necropsy results demonstrated acid-fast positive bacteria in lung tissue and supported the diagnosis of M. abscessus pneumonia. Acid-fast stains and mycobacteria cultures should be considered when evaluating ill dolphins. PMID:23272373

Alzheimer’s Prevention Initiative: A Plan to Accelerate the Evaluation of Presymptomatic Treatments

PubMed Central

Reiman, Eric M.; Langbaum, Jessica B.S.; Fleisher, Adam S.; Caselli, Richard J.; Chen, Kewei; Ayutyanont, Napatkamon; Quiroz, Yakeel T.; Kosik, Kenneth S.; Lopera, Francisco; Tariot, Pierre N.

2012-01-01

There is an urgent need to find effective presymptomatic Alzheimer’s disease (AD) treatments that reduce the risk of AD symptoms or prevent them completely. It currently takes too many healthy people, too much money and too many years to evaluate the range of promising presymptomatic treatments using clinical endpoints. We have used brain imaging and other measurements to track some of the earliest changes associated with the predisposition to AD. We have proposed the Alzheimer’s Prevention Initiative (API) to evaluate investigational amyloid-modifying treatments in healthy people who, based on their age and genetic background, are at the highest imminent risk of developing symptomatic AD using brain imaging, cerebrospinal fluid (CSF), and cognitive endpoints. In one trial, we propose to study AD-causing presenilin 1 [PS1] mutation carriers from the world’s largest early-onset AD kindred in Antioquia, Colombia, close to their estimated average age at clinical onset. In another trial, we propose to study apolipoprotein E (APOE)ε4 homozygotes (and possibly heterozygotes) close to their estimated average age at clinical onset. The API has several goals: 1) to evaluate investigational AD-modifying treatments sooner than otherwise possible; 2) to determine the extent to which the treatment’s brain imaging and other biomarker effects predict a clinical benefit—information needed to help qualify biomarker endpoints for use in pivotal prevention trials; 3) to provide a better test of the amyloid hypothesis than clinical trials in symptomatic patients, when these treatments may be too little too late to exert their most profound effect; 4) to establish AD prevention registries needed to support these and other presymptomatic AD trials; and 5) to give those individuals at highest imminent risk of AD symptoms access to the most promising investigational treatments in clinical trials. PMID:21971471

[Evaluation of the first training on clinical research methodology in Chile].

PubMed

Espinoza, Manuel; Cabieses, Báltica; Pedreros, César; Zitko, Pedro

2011-03-01

This paper describes the evaluation of the first training on clinical research methodology in Chile (EMIC-Chile) 12 months after its completion. An online survey was conducted for students and the Delphi method was used for the teaching team. Among the students, the majority reported that the program had contributed to their professional development and that they had shared some of the knowledge acquired with colleagues in their workplace. Forty-one percent submitted a project to obtain research funding through a competitive grants process once they had completed the course. Among the teachers, the areas of greatest interest were the communication strategy, teaching methods, the characteristics of the teaching team, and potential strategies for making the EMIC-Chile permanent in the future. This experience could contribute to future research training initiatives for health professionals. Recognized challenges are the involvement of nonmedical professions in clinical research, the complexities associated with the distance learning methodology, and the continued presence of initiatives of this importance at the national and regional level.

Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial.

PubMed

Thompson, Kirsten M J; Rocca, Corinne H; Kohn, Julia E; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J Joseph; Darney, Philip D; Harper, Cynthia C

2016-03-01

We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011-2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Public funding and provider training substantially improve LARC access.

Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility.

PubMed

da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

2015-01-01

to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context.

Clinical factors predicting bacteremia in low-risk febrile neutropenia after anti-cancer chemotherapy.

PubMed

Ha, Young Eun; Song, Jae-Hoon; Kang, Won Ki; Peck, Kyong Ran; Chung, Doo Ryeon; Kang, Cheol-In; Joung, Mi-Kyong; Joo, Eun-Jeong; Shon, Kyung Mok

2011-11-01

Bacteremia is an important clinical condition in febrile neutropenia that can cause clinical failure of antimicrobial therapy. The purpose of this study was to investigate the clinical factors predictive of bacteremia in low-risk febrile neutropenia at initial patient evaluation. We performed a retrospective cohort study in a university hospital in Seoul, Korea, between May 1995 and May 2007. Patients who met the criteria of low-risk febrile neutropenia at the time of visit to emergency department after anti-cancer chemotherapy were included in the analysis. During the study period, 102 episodes of bacteremia were documented among the 993 episodes of low-risk febrile neutropenia. Single gram-negative bacteremia was most frequent. In multivariate regression analysis, initial body temperature ≥39°C, initial hypotension, presence of clinical sites of infection, presence of central venous catheter, initial absolute neutrophil count <50/mm(3), and the CRP ≥10 mg/dL were statistically significant predictors for bacteremia. A scoring system using these variables was derived and the likelihood of bacteremia was well correlated with the score points with AUC under ROC curve of 0.785. Patients with low score points had low rate of bacteremia, thus, would be candidates for outpatient-based or oral antibiotic therapy. We identified major clinical factors that can predict bacteremia in low-risk febrile neutropenia.

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.

Fever as an initial manifestation of spondyloarthritis: A retrospective study.

PubMed

Byun, Se Jin; Bae, William Han; Jung, Seung Min; Lee, Sang-Won; Park, Yong-Beom; Song, Jason Jungsik

2017-01-01

We aimed to evaluate a wide spectrum of clinical features of adult patients with spondyloarthritis (SpA) whose initial manifestation was fever, using the Assessment of SpondyloArthritis international Society (ASAS) classification criteria. We retrospectively collected the electronic medical records of hospitalized SpA patients who initially presented to the Severance Hospital (Seoul, Korea) with fever from January 2010 to May 2016. As a control group, we also recruited one-hundred consecutive patients who were diagnosed with SpA in our outpatient clinic. Clinical features and laboratory findings were compared in two patient groups. There were 26 patients who had fever as initial presentation of SpA (reactive arthritis 50%, undifferentiated SpA 26.9%, ankylosing spondylitis 15.4%, enteropathic arthritis 3.8%, psoriatic arthritis 3.8%). Peripheral SpA was more common in febrile SpA patients than in control SpA patients (65.4% vs 24.0%, p<0.001). Febrile SpA patients were less frequently HLA-B27 positive than control SpA patients (52.2% vs 77.0%, p<0.05). At baseline, systemic inflammatory markers were significantly higher in the febrile SpA patients (white blood cell count, 11.57 vs 7.81 cells/μL, p<0.001; erythrocyte sedimentation rate, 69.2 vs 41.0 mm/h, p<0.001; C-reactive protein, 109.6 vs 15.3 mg/L, p<0.001). The proportion of patients treated with systemic steroids was significantly higher in febrile SpA patients (57.7% vs. 11.0%, p<0.001). The proportion of patients who visited rheumatology specialty was significantly lower in febrile SpA patients than in control SpA patients (7.7% vs 59.0%, p<0.001). Various subgroups of SpA can be presented with fever as an initial manifestation. Febrile SpA patients demonstrated higher systemic inflammation and a lower chance to visit rheumatology in early stage. When evaluating febrile patients with any clinical features of SpA, clinicians are advised to consider performing SpA-focused evaluation including HLA-B27 or a simple sacroiliac joint radiograph.

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.

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.

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

Out of control little-used clinical assets are draining healthcare budgets.

PubMed

Horblyuk, Ruslan; Kaneta, Kristopher; McMillen, Gary L; Mullins, Christopher; O'Brien, Thomas M; Roy, Ankita

2012-07-01

To improve utilization and reduce the cost of maintaining mobile clinical equipment, healthcare organization leaders should do the following: Select an initial asset group to target. Conduct a physical inventory. Evaluate the organization's asset "ecosystem." Optimize workflow processes. Phase in new processes, and phase out inventory. Devote time to change management. Develop a replacement strategy.

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.

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.

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.

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.

Toward a Cognitive Task Analysis for Biomedical Query Mediation

PubMed Central

Hruby, Gregory W.; Cimino, James J.; Patel, Vimla; Weng, Chunhua

2014-01-01

In many institutions, data analysts use a Biomedical Query Mediation (BQM) process to facilitate data access for medical researchers. However, understanding of the BQM process is limited in the literature. To bridge this gap, we performed the initial steps of a cognitive task analysis using 31 BQM instances conducted between one analyst and 22 researchers in one academic department. We identified five top-level tasks, i.e., clarify research statement, explain clinical process, identify related data elements, locate EHR data element, and end BQM with either a database query or unmet, infeasible information needs, and 10 sub-tasks. We evaluated the BQM task model with seven data analysts from different clinical research institutions. Evaluators found all the tasks completely or semi-valid. This study contributes initial knowledge towards the development of a generalizable cognitive task representation for BQM. PMID:25954589

Toward a cognitive task analysis for biomedical query mediation.

PubMed

Hruby, Gregory W; Cimino, James J; Patel, Vimla; Weng, Chunhua

2014-01-01

In many institutions, data analysts use a Biomedical Query Mediation (BQM) process to facilitate data access for medical researchers. However, understanding of the BQM process is limited in the literature. To bridge this gap, we performed the initial steps of a cognitive task analysis using 31 BQM instances conducted between one analyst and 22 researchers in one academic department. We identified five top-level tasks, i.e., clarify research statement, explain clinical process, identify related data elements, locate EHR data element, and end BQM with either a database query or unmet, infeasible information needs, and 10 sub-tasks. We evaluated the BQM task model with seven data analysts from different clinical research institutions. Evaluators found all the tasks completely or semi-valid. This study contributes initial knowledge towards the development of a generalizable cognitive task representation for BQM.

Cambridge community Optometry Glaucoma Scheme.

PubMed

Keenan, Jonathan; Shahid, Humma; Bourne, Rupert R; White, Andrew J; Martin, Keith R

2015-04-01

With a higher life expectancy, there is an increased demand for hospital glaucoma services in the United Kingdom. The Cambridge community Optometry Glaucoma Scheme (COGS) was initiated in 2010, where new referrals for suspected glaucoma are evaluated by community optometrists with a special interest in glaucoma, with virtual electronic review and validation by a consultant ophthalmologist with special interest in glaucoma. 1733 patients were evaluated by this scheme between 2010 and 2013. Clinical assessment is performed by the optometrist at a remote site. Goldmann applanation tonometry, pachymetry, monoscopic colour optic disc photographs and automated Humphrey visual field testing are performed. A clinical decision is made as to whether a patient has glaucoma or is a suspect, and referred on or discharged as a false positive referral. The clinical findings, optic disc photographs and visual field test results are transmitted electronically for virtual review by a consultant ophthalmologist. The number of false positive referrals from initial referral into the scheme. Of the patients, 46.6% were discharged at assessment and a further 5.7% were discharged following virtual review. Of the patients initially discharged, 2.8% were recalled following virtual review. Following assessment at the hospital, a further 10.5% were discharged after a single visit. The COGS community-based glaucoma screening programme is a safe and effective way of evaluating glaucoma referrals in the community and reducing false-positive referrals for glaucoma into the hospital system. © 2014 Royal Australian and New Zealand College of Ophthalmologists.

The STAR Data Reporting Guidelines for Clinical High Altitude Research.

PubMed

Brodmann Maeder, Monika; Brugger, Hermann; Pun, Matiram; Strapazzon, Giacomo; Dal Cappello, Tomas; Maggiorini, Marco; Hackett, Peter; Bärtsch, Peter; Swenson, Erik R; Zafren, Ken

2018-03-01

Brodmann Maeder, Monika, Hermann Brugger, Matiram Pun, Giacomo Strapazzon, Tomas Dal Cappello, Marco Maggiorini, Peter Hackett, Peter Baärtsch, Erik R. Swenson, Ken Zafren (STAR Core Group), and the STAR Delphi Expert Group. The STARdata reporting guidelines for clinical high altitude research. High AltMedBiol. 19:7-14, 2018. The goal of the STAR (STrengthening Altitude Research) initiative was to produce a uniform set of key elements for research and reporting in clinical high-altitude (HA) medicine. The STAR initiative was inspired by research on treatment of cardiac arrest, in which the establishment of the Utstein Style, a uniform data reporting protocol, substantially contributed to improving data reporting and subsequently the quality of scientific evidence. The STAR core group used the Delphi method, in which a group of experts reaches a consensus over multiple rounds using a formal method. We selected experts in the field of clinical HA medicine based on their scientific credentials and identified an initial set of parameters for evaluation by the experts. Of 51 experts in HA research who were identified initially, 21 experts completed both rounds. The experts identified 42 key parameters in 5 categories (setting, individual factors, acute mountain sickness and HA cerebral edema, HA pulmonary edema, and treatment) that were considered essential for research and reporting in clinical HA research. An additional 47 supplemental parameters were identified that should be reported depending on the nature of the research. The STAR initiative, using the Delphi method, identified a set of key parameters essential for research and reporting in clinical HA medicine.

Expectations for Visual Function: An Initial Evaluation of a New Clinical Instrument.

ERIC Educational Resources Information Center

Corn, Anne L.; Webne, Steve L.

2001-01-01

A study explored the internal consistency of items in a visual screening instrument developed by Project PAVE: Expectations for Visual Functioning (EVF). The test includes 20 items that evaluate a child's functional use of vision. A pilot test involving 129 teachers indicates the EFV is internally consistent. (Contains three references.) (CR)

The effect of pre-service training on post-graduation skill and knowledge retention among mid-level healthcare providers in Mozambique.

PubMed

Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Cesar, Freide; Augusto, Gerito; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

2015-04-16

Mozambique suffers from critical shortages of healthcare workers including non-physician clinicians, Tecnicos de Medicina Geral (TMGs), who are often senior clinicians in rural health centres. The Mozambique Ministry of Health and the International Training and Education Center for Health, University of Washington, Seattle, revised the national curriculum to improve TMG clinical knowledge and skills. To evaluate the effort, data was collected at graduation and 10 months later from pre-revision (initial) and revised curriculum TMGs to determine the following: (1) Did cohorts trained in the revised curriculum score higher on measurements of clinical knowledge, physical exam procedures, and solving clinical case scenarios than those trained in the initial curriculum; (2) Did TMGs in both curricula retain their knowledge over time (from baseline to follow-up); and (3) Did skills and knowledge retention differ over time by curricula? Post-graduation and over time results are presented. t-tests examine differences in scores between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related, demographic, and workplace factors associated with scores on each of three evaluation methods at the p < 0.05 level. Paired t-tests examine within-group changes over time. ANOVA models explore differences between Health Training Institutes (HTIs). Generalized estimating equations determine whether change in scores over time differed by curricula. Mean scores of initial curriculum TMGs at follow-up were 52.7%, 62.6%, and 40.0% on the clinical cases, knowledge test, and physical exam, respectively. Averages were significantly higher among the revised group for clinical cases (60.2%; p < 0.001) and physical exam (47.6%; p < 0.001). HTI was influential on clinical case and physical exam scores. Between graduation and follow-up, clinical case and physical exam scores decreased significantly for initial curriculum students; clinical case scores increased significantly among revised curriculum TMGs. Although curriculum revision had limited effect, marginal improvements in the revised group show promise that these TMGs may have increased ability to synthesize clinical information. Weaknesses in curriculum and practicum implementation likely compromised the effect of curriculum revision. An improvement strategy that includes strengthened TMG training, greater attention to pre-service clinical practice, and post-graduation mentoring may be more advantageous than curriculum revision, alone, to improve care provided by TMGs.

Transformation of a dental school's clinical assessment system through Kotter's eight-step change process.

PubMed

Guzmán, Wilda Z; Gely, María I; Crespo, Kathleen; Matos, José R; Sánchez, Nilda; Guerrero, Lidia M

2011-04-01

A revision of the clinical assessment system of the University of Puerto Rico School of Dental Medicine was initiated in 2007, with the goal of achieving a system that would be fully understood and used by both faculty and students to improve student performance throughout the curriculum. The transformation process was organized according to Kotter's Eight-Step Change Model. Some of the initial findings in 2007 were as follows: 87 percent of current daily clinical evaluations were scored at the scale's highest level, 33 percent of faculty members lacked knowledge of the evaluation system, and 60 percent of students reported that faculty members were not well calibrated. As a result of the transformation process, a pilot project has been implemented in the comprehensive clinical course for senior students. The revised assessment methods utilized are verbal daily feedback, clinical evaluations once every three months, a digital portfolio, and competency exams. There is also a productivity component included in the course grade. We conclude that adapting Kotter's model for use in the transformation process has been very useful; gaining support from both the administration and faculty has been essential; and the provision of continuous faculty development activities has been empowering. The American Dental Education Association Commission on Change and Innovation in Dental Education (ADEA CCI) Liaisons at the University of Puerto Rico School of Dental Medicine have been effective in producing a greater awareness among the faculty about the value of the competency-based curriculum and the need for change.

The Dream

PubMed Central

Glucksman, Myron L.

2001-01-01

The dream is a unique psychodynamically informative instrument for evaluating the subjective correlates of brain activity during REM sleep. These include feelings, percepts, memories, wishes, fantasies, impulses, conflicts, and defenses, as well as images of self and others. Dream analysis can be used in a variety of clinical settings to assist in diagnostic assessment, psychodynamic formulation, evaluation of clinical change, and the management of medically ill patients. Dreams may serve as the initial indicators of transference, resistance, impending crisis, acting-out, conflict resolution, and decision-making. A clinically functional categorization of dreams can facilitate an understanding of psychopathology, psychodynamics, personality structure, and various components of the psychotherapeutic process. Examples of different types of dreams are provided to illustrate their relevance and use in various clinical situations. PMID:11696648

4D co-registration of X-ray and MR-mammograms: initial clinical results and potential incremental diagnostic value.

PubMed

Dietzel, Matthias; Hopp, Torsten; Ruiter, Nicole V; Kaiser, Clemens G; Kaiser, Werner A; Baltzer, Pascal A

2015-01-01

4D co-registration of X-ray- and MR-mammograms (XM and MM) is a new method of image fusion. The present study aims to evaluate its clinical feasibility, radiological accuracy, and potential clinical value. XM and MM of 25 patients were co-registered. Results were evaluated by a blinded reader. Precision of the 4D co-registration was "very good" (mean-score [ms]=7), and lesions were "easier to delineate" (ms=5). In 88.8%, "relevant additional diagnostic information" was present, accounting for a more "confident diagnosis" in 76% (ms=5). 4D co-registration is feasible, accurate, and of potential clinical value. Copyright © 2015 Elsevier Inc. All rights reserved.

The dream: a psychodynamically informative instrument.

PubMed

Glucksman, M L

2001-01-01

The dream is a unique psychodynamically informative instrument for evaluating the subjective correlates of brain activity during REM sleep. These include feelings, percepts, memories, wishes, fantasies, impulses, conflicts, and defenses, as well as images of self and others. Dream analysis can be used in a variety of clinical settings to assist in diagnostic assessment, psychodynamic formulation, evaluation of clinical change, and the management of medically ill patients. Dreams may serve as the initial indicators of transference, resistance, impending crisis, acting-out, conflict resolution, and decision-making. A clinically functional categorization of dreams can facilitate an understanding of psychopathology, psychodynamics, personality structure, and various components of the psychotherapeutic process. Examples of different types of dreams are provided to illustrate their relevance and use in various clinical situations.

Drug-induced sleep endoscopy changes snoring management plan very significantly compared to standard clinical evaluation.

PubMed

Pilaete, Karen; De Medts, Joris; Delsupehe, Kathelijne Godelieve

2014-05-01

Drug-induced sleep endoscopy (DISE) is a new tool in the work-up of patients with sleep-disordered breathing (SDB). We assessed the impact of DISE on the treatment plan of snoring patients. This is a single institution prospective longitudinal clinical trial. The setting is a private teaching hospital. A consecutive series of 100 snoring patients prospectively underwent a standardised questionnaire, clinical examination, rhinomanometry, allergy skin prick testing, DISE and polysomnography. Management plan before and after DISE evaluation was compared. In 61 patients (excluding 16 patients sent for continuous positive airway pressure, three patients refused sleep endoscopy and 20 were lost to follow-up), we compared the treatment plans. DISE showed single level airway collapse in 13 and multilevel collapse in 48 patients. The site of flutter did not add additional information as compared to the pattern and the location of the collapse. After DISE, the initial management plan changed in 41% of patients irrespective of the type of initial management plan. The only somewhat accurate initial treatment plan was uvulopalatopharyngoplasty (unchanged in 11/13 patients). Excluding moderate to severe obstructive sleep apnea patients DISE is an indispensable tool in treatment decision in all SDB patients. We suggest to simplify the protocol for DISE reporting.

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.

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.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; Bart van der Worp, H; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Scala Moy, Claudia; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2018-05-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility 1

PubMed Central

da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

2015-01-01

AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806631

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.

Longitudinal changes in white matter disease and cognition in the first year of the Alzheimer disease neuroimaging initiative.

PubMed

Carmichael, Owen; Schwarz, Christopher; Drucker, David; Fletcher, Evan; Harvey, Danielle; Beckett, Laurel; Jack, Clifford R; Weiner, Michael; DeCarli, Charles

2010-11-01

To evaluate relationships between magnetic resonance imaging (MRI)-based measures of white matter hyperintensities (WMHs), measured at baseline and longitudinally, and 1-year cognitive decline using a large convenience sample in a clinical trial design with a relatively mild profile of cardiovascular risk factors. Convenience sample in a clinical trial design. A total of 804 participants in the Alzheimer Disease Neuroimaging Initiative who received MRI scans, cognitive testing, and clinical evaluations at baseline, 6-month follow-up, and 12-month follow-up visits. For each scan, WMHs were detected automatically on coregistered sets of T1, proton density, and T2 MRI images using a validated method. Mixed-effects regression models evaluated relationships between risk factors for WMHs, WMH volume, and change in outcome measures including Mini-Mental State Examination (MMSE), Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and Clinical Dementia Rating Scale sum of boxes scores. Covariates in these models included race, sex, years of education, age, apolipoprotein E genotype, baseline clinical diagnosis (cognitively normal, mild cognitive impairment, or Alzheimer disease), cardiovascular risk score, and MRI-based hippocampal and brain volumes. Higher baseline WMH volume was associated with greater subsequent 1-year increase in ADAS-Cog and decrease in MMSE scores. Greater WMH volume at follow-up was associated with greater ADAS-Cog and lower MMSE scores at follow-up. Higher baseline age and cardiovascular risk score and more impaired baseline clinical diagnosis were associated with higher baseline WMH volume. White matter hyperintensity volume predicts 1-year cognitive decline in a relatively healthy convenience sample that was similar to clinical trial samples, and therefore should be considered as a covariate of interest at baseline and longitudinally in future AD treatment trials.

Monitoring Compliance to Promote Quality Assurance: Development of a Mental Health Clinical Chart Audit Tool in Belize, 2013.

PubMed

Winer, Rachel A; Bennett, Eleanor; Murillo, Illouise; Schuetz-Mueller, Jan; Katz, Craig L

2015-09-01

Belize trained psychiatric nurse practitioners (PNPs) in the early 1990s to provide mental health services throughout the country. Despite overwhelming success, the program is limited by lack of monitoring, evaluation, and surveillance. To promote quality assurance, we developed a chart audit tool to monitor mental healthcare delivery compliance for initial psychiatric assessment notes completed by PNPs. After reviewing the Belize Health Information System electronic medical record system, we developed a clinical audit tool to capture 20 essential components for initial assessment clinical notes. The audit tool was then piloted for initial assessment notes completed during July through September of 2013. One hundred and thirty-four initial psychiatric interviews were audited. The average chart score among all PNPs was 9.57, ranging from 3 to 15. Twenty-three charts-or 17.2%-had a score of 14 or higher and met a 70% compliance benchmark goal. Among indicators most frequently omitted included labs ordered and named (15.7%) and psychiatric diagnosis (21.6%). Explicit statement of medications initiated with dose and frequency occurred in 47.0% of charts. Our findings provide direction for training and improvement, such as emphasizing the importance of naming labs ordered, medications and doses prescribed, and psychiatric diagnoses in initial assessment clinical notes. We hope this initial assessment helps enhance mental health delivery compliance by prompting creation of BHIS templates, development of audits tools for revisit follow-up visits, and establishment of corrective actions for low-scoring practitioners. These efforts may serve as a model for implementing quality assurance programming in other low resource settings.

Towards earlier inclusion of Children in Tuberculosis (TB) drugs trials: Consensus statements from an Expert Panel

PubMed Central

Nachman, Sharon; Ahmed, Amina; Amanullah, Farhana; Becerra, Mercedes C; Botgros, Radu; Brigden, Grania; Browning, Renee; Gardiner, Elizabeth; Hafner, Richard; Hesseling, Anneke; How, Cleotilde; Jean-Philippe, Patrick; Lessem, Erica; Makhene, Mamodikoe; Mbelle, Nontombi; Marais, Ben; McIlleron, Helen; Mc Neeley, David F; Mendel, Carl; Murray, Stephen; Navarro, Eileen; Oramasionwu, Gloria E; Porcalla, Ariel R; Powell, Clydette; Powell, Mair; Rigaud, Mona; Rouzier, Vanessa; Samson, Pearl; Schaaf, H. Simon; Shah, Seema; Starke, Jeff; Swaminathan, Soumya; Wobudeya, Eric; Worrell, Carol

2015-01-01

Children represent a significant proportion of the global tuberculosis (TB) burden, and may be disproportionately more affected by its most severe clinical manifestations. Currently available treatments for pediatric drug-susceptible (DS) and drug-resistant (DR) TB, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxicities, and an overall lack of suitable, child-friendly formulations. The complex and burdensome nature of administering the existing regimens to treat DS TB also contributes to the rise of DR TB strains. Despite the availability and use of these therapies for decades, a dearth of dosing evidence in children underscores the importance of sustained efforts for TB drug development to better meet the treatment needs of children with TB. Several new TB drugs and regimens with promising activity against both DS and DR TB strains have recently entered clinical development and are in various phases of clinical evaluation in adults or have received marketing authorization for adults. However, initiation of clinical trials to evaluate these drugs in children is often deferred, pending the availability of complete safety and efficacy data in adults or after drug approval. This document summarizes consensus statements from an international panel of childhood TB opinion leaders which support the initiation of evaluation of new TB drugs and regimens in children at earlier phases of the TB Drug development cycle. PMID:25957923

Kaiser Permanente implant registries benefit patient safety, quality improvement, cost-effectiveness.

PubMed

Paxton, Elizabeth W; Kiley, Mary-Lou; Love, Rebecca; Barber, Thomas C; Funahashi, Tadashi T; Inacio, Maria C S

2013-06-01

In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

PubMed

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

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.

Iterative integral parameter identification of a respiratory mechanics model.

PubMed

Schranz, Christoph; Docherty, Paul D; Chiew, Yeong Shiong; Möller, Knut; Chase, J Geoffrey

2012-07-18

Patient-specific respiratory mechanics models can support the evaluation of optimal lung protective ventilator settings during ventilation therapy. Clinical application requires that the individual's model parameter values must be identified with information available at the bedside. Multiple linear regression or gradient-based parameter identification methods are highly sensitive to noise and initial parameter estimates. Thus, they are difficult to apply at the bedside to support therapeutic decisions. An iterative integral parameter identification method is applied to a second order respiratory mechanics model. The method is compared to the commonly used regression methods and error-mapping approaches using simulated and clinical data. The clinical potential of the method was evaluated on data from 13 Acute Respiratory Distress Syndrome (ARDS) patients. The iterative integral method converged to error minima 350 times faster than the Simplex Search Method using simulation data sets and 50 times faster using clinical data sets. Established regression methods reported erroneous results due to sensitivity to noise. In contrast, the iterative integral method was effective independent of initial parameter estimations, and converged successfully in each case tested. These investigations reveal that the iterative integral method is beneficial with respect to computing time, operator independence and robustness, and thus applicable at the bedside for this clinical application.

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.

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

Development and Application of a Computer Simulation Program to Enhance the Clinical Problem-Solving Skills of Students.

ERIC Educational Resources Information Center

Boh, Larry E.; And Others

1987-01-01

A project to (1) develop and apply a microcomputer simulation program to enhance clinical medication problem solving in preclerkship and clerkship students and (2) perform an initial formative evaluation of the simulation is described. A systematic instructional design approach was used in applying the simulation to the disease state of rheumatoid…

Evaluation of clinical, laboratory, imaging findings and outcome in 99 dogs with leptospirosis.

PubMed

Knöpfler, S; Mayer-Scholl, A; Luge, E; Klopfleisch, R; Gruber, A D; Nöckler, K; Kohn, B

2017-10-01

To report clinical, laboratory and diagnostic imaging features and prognostic factors in dogs with leptospirosis from North-East Germany. Medical records of dogs diagnosed with leptospirosis from 2006 to 2013 were evaluated retrospectively. The study included 99 dogs. At initial presentation, the most common clinical signs were lethargy (96%), anorexia (88%), vomiting (85%), painful abdomen (39%), diarrhoea (38%), oliguria (27%) and tachypnoea (26%). Abnormal laboratory findings included anaemia (63%), thrombocytopenia (63%), leucocytosis (57%), increase of plasma urea (84%) and creatinine concentrations (81%), increased liver enzyme activities (80%), hyperbilirubinaemia (69%), hyperphosphataemia (67%), hyponatraemia (64%), hypoalbuminaemia (55%) and hypokalaemia (29%). Radiological pulmonary changes were detected in 57% of the dogs initially or during the course of disease. Severe dyspnoea, oliguria, azotaemia, hyperbilirubinaemia and severe radiological pulmonary changes were more often found in dogs that did not survive. There was renal, hepatic and pulmonary involvement in 95, 92 and 58% of the dogs, respectively, and multi-organ lesions in 98 dogs (98%); 32 dogs died or were euthanased. Several clinical and laboratory abnormalities were associated with a negative outcome; severe lung involvement was specifically associated with high mortality. © 2017 British Small Animal Veterinary Association.

The PBRN Initiative

PubMed Central

Curro, F.A.; Vena, D.; Naftolin, F.; Terracio, L.; Thompson, V.P.

2012-01-01

The NIDCR-supported Practice-based Research Network initiative presents dentistry with an unprecedented opportunity by providing a pathway for modifying and advancing the profession. It encourages practitioner participation in the transfer of science into practice for the improvement of patient care. PBRNs vary in infrastructure and design, and sustaining themselves in the long term may involve clinical trial validation by regulatory agencies. This paper discusses the PBRN concept in general and uses the New York University College of Dentistry’s Practitioners Engaged in Applied Research and Learning (PEARL) Network as a model to improve patient outcomes. The PEARL Network is structured to ensure generalizability of results, data integrity, and to provide an infrastructure in which scientists can address clinical practitioner research interests. PEARL evaluates new technologies, conducts comparative effectiveness research, participates in multidisciplinary clinical studies, helps evaluate alternative models of healthcare, educates and trains future clinical faculty for academic positions, expands continuing education to include “benchmarking” as a form of continuous feedback to practitioners, adds value to dental schools’ educational programs, and collaborates with the oral health care and pharmaceutical industries and medical PBRNs to advance the dental profession and further the integration of dental research and practice into contemporary healthcare (NCT00867997, NCT01268605). PMID:22699662

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).

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.

Developing Brain Vital Signs: Initial Framework for Monitoring Brain Function Changes Over Time

PubMed Central

Ghosh Hajra, Sujoy; Liu, Careesa C.; Song, Xiaowei; Fickling, Shaun; Liu, Luke E.; Pawlowski, Gabriela; Jorgensen, Janelle K.; Smith, Aynsley M.; Schnaider-Beeri, Michal; Van Den Broek, Rudi; Rizzotti, Rowena; Fisher, Kirk; D'Arcy, Ryan C. N.

2016-01-01

Clinical assessment of brain function relies heavily on indirect behavior-based tests. Unfortunately, behavior-based assessments are subjective and therefore susceptible to several confounding factors. Event-related brain potentials (ERPs), derived from electroencephalography (EEG), are often used to provide objective, physiological measures of brain function. Historically, ERPs have been characterized extensively within research settings, with limited but growing clinical applications. Over the past 20 years, we have developed clinical ERP applications for the evaluation of functional status following serious injury and/or disease. This work has identified an important gap: the need for a clinically accessible framework to evaluate ERP measures. Crucially, this enables baseline measures before brain dysfunction occurs, and might enable the routine collection of brain function metrics in the future much like blood pressure measures today. Here, we propose such a framework for extracting specific ERPs as potential “brain vital signs.” This framework enabled the translation/transformation of complex ERP data into accessible metrics of brain function for wider clinical utilization. To formalize the framework, three essential ERPs were selected as initial indicators: (1) the auditory N100 (Auditory sensation); (2) the auditory oddball P300 (Basic attention); and (3) the auditory speech processing N400 (Cognitive processing). First step validation was conducted on healthy younger and older adults (age range: 22–82 years). Results confirmed specific ERPs at the individual level (86.81–98.96%), verified predictable age-related differences (P300 latency delays in older adults, p < 0.05), and demonstrated successful linear transformation into the proposed brain vital sign (BVS) framework (basic attention latency sub-component of BVS framework reflects delays in older adults, p < 0.05). The findings represent an initial critical step in developing, extracting, and characterizing ERPs as vital signs, critical for subsequent evaluation of dysfunction in conditions like concussion and/or dementia. PMID:27242415

Training Partnership Dyads for Community-Based Participatory Research: Strategies and Lessons Learned From the Community Engaged Scholars Program

PubMed Central

Andrews, Jeannette O.; Cox, Melissa J.; Newman, Susan D.; Gillenwater, Gwen; Warner, Gloria; Winkler, Joyce A.; White, Brandi; Wolf, Sharon; Leite, Renata; Ford, Marvella E.; Slaughter, Sabra

2014-01-01

This article describes the development, implementation, evaluation framework, and initial outcomes of a unique campus–community training initiative for community-based participatory research (CBPR). The South Carolina Clinical & Translational Research Center for Community Health Partnerships, which functions as the institution’s Clinical Translational and Science Award Community Engagement Program, leads the training initiative known as the Community Engaged Scholars Program (CES-P). The CES-P provides simultaneous training to CBPR teams, with each team consisting of at least one community partner and one academic partner. Program elements include 12 months of monthly interactive group sessions, mentorship with apprenticeship opportunities, and funding for a CBPR pilot project. A modified RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework guides the process, impact, and outcome evaluation plan. Lessons learned include challenges of group instruction with varying levels of readiness among the CBPR partners, navigating the institutional review board process with community co-investigators, and finding appropriate academic investigators to match community research interests. Future directions are recommended for this promising and unique dyadic training of academic and community partners. PMID:23091303

Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial

PubMed Central

Rocca, Corinne H.; Kohn, Julia E.; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J. Joseph; Darney, Philip D.; Harper, Cynthia C.

2016-01-01

Objectives. We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. Methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011–2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Results. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Conclusions. Public funding and provider training substantially improve LARC access. PMID:26794168

Clinical and Economic Outcomes Associated With the Timing of Initiation of Basal Insulin in Patients With Type 2 Diabetes Mellitus Previously Treated With Oral Antidiabetes Drugs.

PubMed

Levin, Philip; Zhou, Steve; Durden, Emily; Farr, Amanda M; Gill, Jasvinder; Wei, Wenhui

2016-01-01

In patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective database analysis investigated clinical and economic outcomes associated with the timing of insulin initiation in patients with T2DM treated with ≥1 OAD in a real-world US setting. This study linked data from the Truven Health MarketScan(®) Commercial database, Medicare Supplemental database, and Quintiles Electronic Medical Records database. A total of 1830 patients with T2DM were included. Patients were grouped according to their OAD use before basal insulin initiation (1, 2, or ≥3 OADs) as a proxy for the timing of insulin initiation. Clinical and economic outcomes were evaluated over 1 year of follow-up. During follow-up the 1 OAD group, compared with the 2 and ≥3 OADs groups, had a greater reduction in glycosylated hemoglobin A1c (-1.7% vs -1.0% vs -0.9%, respectively; P < 0.0001), greater achievement of glycemic target (38.2% vs 26.7% vs 19.6%, respectively; P < 0.0001), and a lower incidence of hypoglycemia (2.7% vs 6.6% vs 5.0%, respectively; P = 0.0002), with no difference in total health care costs ($21,167 vs $21,060 vs $20,133, respectively). This study shows that early insulin initiation (represented by the 1 OAD group) may be clinically beneficial to patients with T2DM not controlled with OADs, without adding to costs. This supports the call for timely initiation of individualized insulin therapy in this population. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Clinical staging: its importance in therapeutic decisions and clinical trials.

PubMed

Denis, L J

1992-02-01

International collaboration has resulted in a revised and unified 1987 formulation for the TNM classification in solid tumors. The simplification and eliminations of most variables caused difficulties for the clinical use of the system in some tumors such as bladder cancer. The approval of the proposed adaptation covering the tumor mass, subdividing the T4 category and adapting the stage grouping, resolves these difficulties. Published reports demonstrate support for the TNM system as a clinical base for treatment decisions and prognosis. The TNMG stage and grade are important basic prognostic factors, but other prognostic factors, especially biologic tumor activity, are under clinical investigation. The TNM classification is the initial evaluation after histologic confirmation of cancer to guide treatment and prognosis. The quality of the evaluation is enhanced by precise communication on the employed methodology.

A Method to Evaluate Critical Factors for Successful Implementation of Clinical Pathways.

PubMed

Dong, W; Huang, Z

2015-01-01

Clinical pathways (CPs) have been viewed as a multidisciplinary tool to improve the quality and efficiency of evidence-based care. Despite widespread enthusiasm for CPs, research has shown that many CP initiatives are unsuccessful. To this end, this study provides a methodology to evaluate critical success factors (CSFs) that can aid healthcare organizations to achieve successful CP implementation. This study presents a new approach to evaluate CP implementation CSFs, with the aims being: (1) to identify CSFs for implementation of CPs through a comprehensive literature review and interviews with collaborative experts; (2) to use a filed study data with a robust fuzzy DEMATEL (the decision making trial and evaluation laboratory) approach to visualize the structure of complicated causal relationships between CSFs and obtain the influence level of these factors. The filed study data is provided by ten clinical experts of a Chinese hospital. 23 identified CSF factors which are initially identified through a review of the literature and interviews with collaborative experts. Then, a number of direct and indirect relationships are derived from the data such that different perceptions can be integrated into a compromised cause and effect model of CP implementation. The results indicate that the proposed approach can systematically evaluate CSFs and realize the importance of each factor such that the most common causes of failure of CP implementation could be eliminated or avoided. Therefore, the tool proposed would help healthcare organizations to manage CP implementation in a more effective and proactive way.

A Re-Examination of Neuropsychological Functioning in Persian Gulf War Era Veterans

DTIC Science & Technology

2003-08-01

neuropsychological evaluations and a group of individuals seeking treatment or diagnostic evaluation for any purpose. Controls were treatment -seeking non deployed...GW-era veterans studied between 1995-1998. The prior finding of differences between the deployed and non-deployed treatment seeking GW-era veterans in...included patients who were initially referred for clinical neuropsychological evaluations and a group of individuals who were seeking treatment or

Resource utilization after introduction of a standardized clinical assessment and management plan.

PubMed

Friedman, Kevin G; Rathod, Rahul H; Farias, Michael; Graham, Dionne; Powell, Andrew J; Fulton, David R; Newburger, Jane W; Colan, Steven D; Jenkins, Kathy J; Lock, James E

2010-01-01

A Standardized Clinical Assessment and Management Plan (SCAMP) is a novel quality improvement initiative that standardizes the assessment and management of all patients who carry a predefined diagnosis. Based on periodic review of systemically collected data the SCAMP is designed to be modified to improve its own algorithm. One of the objectives of a SCAMP is to identify and reduce resource utilization and patient care costs. We retrospectively reviewed resource utilization in the first 93 arterial switch operation (ASO) SCAMP patients and 186 age-matched control ASO patients. We compared diagnostic and laboratory testing obtained at the initial SCAMP clinic visit and control patient visits. To evaluate the effect of the SCAMP over time, the number of clinic visits per patient year and echocardiograms per patient year in historical control ASO patients were compared to the projected rates for ASO SCAMP participants. Cardiac magnetic resonance imaging (MRI), stress echocardiogram, and lipid profile utilization were higher in the initial SCAMP clinic visit group than in age-matched control patients. Total echocardiogram and lung scan usage were similar. Chest X-ray and exercise stress testing were obtained less in SCAMP patients. ASO SCAMP patients are projected to have 0.5 clinic visits and 0.5 echocardiograms per year. Historical control patients had more clinic visits (1.2 vs. 0.5 visits/patient year, P<.01) and a higher echocardiogram rate (0.92 vs. 0.5 echocardiograms/patient year, P<.01) Implementation of a SCAMP may initially lead to increased resource utilization, but over time resource utilization is projected to decrease.

21 CFR 5.1100 - Headquarters.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Laboratories Complex Staff. Division of Engineering Services. Environment, Safety And Strategic Initiatives.... Office of Cellular, Tissue, and Gene Therapies. Regulatory Management Staff. Division of Cellular and Gene Therapies. Division of Clinical Evaluation and Pharmacology/Toxicology. Division of Human Tissues...

How to use PET/CT in the evaluation of response to radiotherapy.

PubMed

Decazes, Pierre; Thureau, Sébastien; Dubray, Bernard; Vera, Pierre

2018-06-01

Radiotherapy is a major treatment modality for many cancers. Tumor response after radiotherapy determines the subsequent steps of the patient's management (surveillance, adjuvant or salvage treatment and palliative care). Tumor response assessed during radiotherapy offers a promising opportunity to adapt the treatment plan to reduced or increased target volume, to specifically target sub-volumes with relevant biological characteristics (metabolism, hypoxia, proliferation, etc.) and to further spare the organs at risk. In addition to its role in the diagnosis and the initial staging, Positron Emission Tomography combined with a Computed Tomography (PET/CT) provides functional information and is therefore attractive to evaluate tumor response. The aim of this paper is to review the published data addressing PET/CT as an evaluation tool in irradiated tumors. Reports on PET/CT acquired at various times (during radiotherapy, after initial (chemo-) radiotherapy, after definitive radiotherapy and during posttreatment follow-up) in solid tumors (lung, head-and-neck, cervix, esophagus, prostate and rectum) were collected and reviewed. Various tracers and technical aspects are also discussed. 18F-FDG PET/CT has a well-established role in clinical routine after definitive chemo-radiotherapy for locally advanced head-and-neck cancers. 18F-choline PET/CT is indicated in prostate cancer patients with biochemical failure. 18F-FDG PET/CT is optional in many other circumstances and the clinical benefits of assessing tumor response with PET/CT remain a field of very active research. The combination of PET with Magnetic Resonance Imaging (PET/MRI) may prove to be valuable in irradiated rectal and cervix cancers. Tumor response can be evaluated by PET/CT with clinical consequences in multiple situations, notably in head and neck and prostate cancers, after radiotherapy. Further clinical evaluation for most cancers is still needed, possibly in association to MRI.

Myxoedema in a patient with achondroplasia in rural area of Guatemala.

PubMed

Juarez, Michel; Rohloff, Peter

2017-03-09

A 43-year-old indigenous Guatemalan woman with achondroplasia presented to our clinic with chronic fatigue and generalised oedema. She had limited contact with the formal healthcare system. However, 1 year prior, she had sought medical evaluation from a private physician. Her symptoms had been attributed to a combination of heart failure and physical disability due to the musculoskeletal complications of her achondroplasia. She was lost to follow-up due to inability to pay for further testing or treatment. On initial laboratory evaluation in our clinic, she was found to have a thyrotropin level greater than assay. With initiation of oral levothyroxine supplementation, her dyspnoea and oedema completely resolved. The case illustrates how indigenous patients in rural Guatemala experience many barriers to accessing high-quality medical care. As a result, presentations of common illnesses are often very advanced and definitive diagnoses and treatments are frequently delayed. 2017 BMJ Publishing Group Ltd.

Utility of the Electrocardiogram in Drug Overdose and Poisoning: Theoretical Considerations and Clinical Implications

PubMed Central

Yates, Christopher; Manini, Alex F

2012-01-01

The ECG is a rapidly available clinical tool that can help clinicians manage poisoned patients. Specific myocardial effects of cardiotoxic drugs have well-described electrocardiographic manifestations. In the practice of clinical toxicology, classic ECG changes may hint at blockade of ion channels, alterations of adrenergic tone, or dysfunctional metabolic activity of the myocardium. This review will offer a structured approach to ECG interpretation in poisoned patients with a focus on clinical implications and ECG-based management recommendations in the initial evaluation of patients with acute cardiotoxicity. PMID:22708912

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.

A pilot registry of unexplained fatiguing illnesses and chronic fatigue syndrome

PubMed Central

2013-01-01

Background Chronic fatigue syndrome (CFS) has no diagnostic clinical signs or biomarkers, so diagnosis requires ruling out conditions with similar signs and symptoms. We conducted a pilot registry of unexplained fatiguing illnesses and CFS to determine the feasibility of establishing and operating a registry and implementing an education outreach initiative. The pilot registry was conducted in Bibb County, Georgia. Patient referrals were obtained from healthcare providers who were identified by using various education outreach initiatives. These referrals were later supplemented with self-referrals by members of a local CFS support group. All patients meeting referral criteria were invited to participate in a screening interview to determine eligibility. If patients met registry criteria, they were invited to a one-day clinic for physical and laboratory evaluations. We classified patients based on the 1994 case definition. Results We registered 827 healthcare providers. Forty-two providers referred 88 patients, and 58 patients (66%) completed clinical evaluation. Of the 188 CFS support group members, 53 were self-referred and 46 (87%) completed the clinical evaluation. Of the 104 participants completing evaluation, 36% (n = 37) met the criteria for CFS, 17% (n = 18) had insufficient fatigue or symptoms (ISF), and 47% (n = 49) were found to have exclusionary medical or psychiatric illnesses. Classification varied significantly by type of referral but not by previous history of CFS diagnosis. Healthcare providers referred more patients who were classified as CFS as compared to support group referrals in which more exclusionary conditions were identified. Family practice and internal medicine specialties made the most referrals and had the highest number of CFS cases. We conducted three CME events, held three “Meet and Greet” sessions, visited four large clinical health practices and health departments, mailed five registry newsletters, and conducted in-person office visits as part of education outreach, which contributed to patient referrals. Conclusions Referrals from healthcare providers and self-referrals from the patient support group were important to registry enrollment. The number of potentially treatable conditions that were identified highlights the need for continued medical management in this population, as well as the limitations of registries formed without clinical examination. Education initiatives were successful in part because of partnerships with local organizations. PMID:23915640

Reflective practice groups for nurses: a consultation liaison psychiatry nursing initiative: part 2--the evaluation.

PubMed

Dawber, Chris

2013-06-01

This paper outlines an evaluation of reflective practice groups (RPG) involving nurses and midwives from three clinical nursing specialties at Redcliffe and Caboolture Hospitals, Queensland, Australia. The groups were facilitated by the consultation liaison psychiatry nurse and author using a process-focused, whole-of-group approach to explore clinical narrative in a supportive group setting. This was a preliminary evaluation utilizing a recently-developed tool, the Clinical Supervision Evaluation Questionnaire, along with externally-facilitated focus groups. Nurses and midwives responded favourably to RPG, reporting a positive impact on clinical practice, self-awareness, and resilience. The majority of participants considered RPG had positive implications for team functioning. The focus groups identified the importance of facilitation style and the need to address aspects of workplace culture to enable group development and enhance the capacity for reflection. Evaluation of the data indicates this style of RPG can improve reflective thinking, promote team cohesion, and provide support for nurses and midwives working in clinical settings. Following on from this study, a second phase of research has commenced, providing more detailed, longitudinal evaluation across a larger, more diverse group of nurses. © 2012 The Author; International Journal of Mental Health Nursing © 2012 Australian College of Mental Health Nurses Inc.

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.

Assessing Patients' Cognitive Therapy Skills: Initial Evaluation of the Competencies of Cognitive Therapy Scale.

PubMed

Strunk, Daniel R; Hollars, Shannon N; Adler, Abby D; Goldstein, Lizabeth A; Braun, Justin D

2014-10-01

In Cognitive Therapy (CT), therapists work to help patients develop skills to cope with negative affect. Most current methods of assessing patients' skills are cumbersome and impractical for clinical use. To address this issue, we developed and conducted an initial psychometric evaluation of self and therapist reported versions of a new measure of CT skills: the Competencies of Cognitive Therapy Scale (CCTS). We evaluated the CCTS at intake and post-treatment in a sample of 67 patients participating in CT. The CCTS correlated with a preexisting measure of CT skills (the Ways of Responding Questionnaire) and was also related to concurrent depressive symptoms. Across CT, self-reported improvements in CT competencies were associated with greater changes in depressive symptoms. These findings offer initial evidence for the validity of the CCTS. We discuss the CCTS in comparison with other measures of CT skills and suggest future research directions.

Assessing Patients’ Cognitive Therapy Skills: Initial Evaluation of the Competencies of Cognitive Therapy Scale

PubMed Central

Strunk, Daniel R.; Hollars, Shannon N.; Adler, Abby D.; Goldstein, Lizabeth A.; Braun, Justin D.

2014-01-01

In Cognitive Therapy (CT), therapists work to help patients develop skills to cope with negative affect. Most current methods of assessing patients’ skills are cumbersome and impractical for clinical use. To address this issue, we developed and conducted an initial psychometric evaluation of self and therapist reported versions of a new measure of CT skills: the Competencies of Cognitive Therapy Scale (CCTS). We evaluated the CCTS at intake and post-treatment in a sample of 67 patients participating in CT. The CCTS correlated with a preexisting measure of CT skills (the Ways of Responding Questionnaire) and was also related to concurrent depressive symptoms. Across CT, self-reported improvements in CT competencies were associated with greater changes in depressive symptoms. These findings offer initial evidence for the validity of the CCTS. We discuss the CCTS in comparison with other measures of CT skills and suggest future research directions. PMID:25408560

Kericho CLinic-based ART Diagnostic Evaluation (CLADE): design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya.

PubMed

Sawe, Fredrick K; Obiero, Eunice; Yegon, Peter; Langat, Rither C; Aoko, Appolonia; Tarus, Jemutai; Kiptoo, Ignatius; Langat, Raphael K; Maswai, Jonah; Bii, Margaret; Khamadi, Samoel; Shikuku, Kibet P; Close, Nicole; Sinei, Samuel; Shaffer, Douglas N

2015-01-01

Prospective clinical trial data regarding routine HIV-1 viral load (VL) monitoring of antiretroviral therapy (ART) in non-research clinics of Sub-Saharan Africa are needed for policy makers. CLinic-based ART Diagnostic Evaluation (CLADE) is a randomized, controlled trial (RCT) evaluating feasibility, superiority, and cost-effectiveness of routine VL vs. standard of care (clinical and immunological) monitoring in adults initiating dual nucleoside reverse transcriptase inhibitor (NRTI)+non-NRTI ART. Participants were randomized (1:1) at 7 predominately rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics. Over 15 months, 820 adults enrolled at 7 sites with 86-152 enrolled per site. Monthly site enrollment ranged from 2-92 participants. Full (100%) informed consent compliance was independently documented. Half (49.9%) had HIV diagnosed through voluntary counseling and testing. Study arms were similar: mostly females (57.6%) aged 37.6 (SD = 9.0) years with low CD4 (166 [SD = 106]) cells/m3). Notable proportions had WHO Stage III or IV disease (28.7%), BMI <18.5 kg/m2 (23.1%), and a history of tuberculosis (5.6%) or were receiving tuberculosis treatment (8.2%) at ART initiation. In the routine VL arm, 407/409 (99.5%) received baseline VL (234,577 SD = 151,055 copies/ml). All participants received lamivudine; 49.8% started zidovudine followed by 38.4% stavudine and 11.8% tenofovir; and, 64.4% received nevirapine as nNRTI (35.6% efavirenz). A RCT can be enrolled successfully in rural, non-research, resource limited, district-level clinics in western Kenya. Many adults presenting for ART have advanced HIV/AIDS, emphasizing the importance of universal HIV testing and linkage-to-care campaigns. ClinicalTrials.gov NCT01791556.

Health Impact Assessment and Evaluation of a Clinical Waste Management Policy for Cameroon

PubMed Central

Mochungong, Peter Ikome Kuwoh

2013-01-01

Health impact assessment (HIA) was carried out to evaluate development of a clinical waste management policy for Cameroon. Fifteen stakeholders of different portfolios within the health sector were selected during a HIA initiating study trip to the Northwest region of Cameroon. Questionnaires were then developed and emailed to the stakeholders. The stakeholders identified cross-contamination, environmental pollution, physical injuries and poor waste management sites as potential risk factors that can be associated with poor clinical waste management. They recommended strong economic and political capital as a prerequisite for the development and implementation of a successful clinical waste policy. Local impacts on health, according to the stakeholders, should be prioritized in deciding any treatment and disposal option. The whole HIA process run through 2008-2010. PMID:28299096

Clinical Management of ADHD in a Family Medicine Residency Program: Comparison with AAP Guidelines.

PubMed

Skelley, Jessica W; Carpenter, P Chase; Morehead, M Shawn; Murphy, Patrick L

2016-06-01

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder. Research has shown that even with the growing incidence of children diagnosed as having ADHD, physicians may find providing optimal care to these patients challenging. Our objective was to contrast existing clinical management of ADHD in a family medicine setting with published American Academy of Pediatrics guidelines and review the literature pertinent to differences. A report was generated for all visits with "ADHD" or "ADD" (attention-deficit disorder) as a current or past medical problem that had been addressed at the family medicine clinic from July 2012 to June 2014. A total of 60 pediatric patients were identified. A retrospective chart review of clinical practice and management patterns for these patients was completed using a standardized data collection form based on the 2011 ADHD treatment guidelines set by the American Academy of Pediatrics. Fifty-seven (95%) patients had documentation of at least one core symptom of ADHD, and 27 (45%) patients had documentation of these symptoms in more than one setting (clinic/school/home). Only 30 (50%) patients were assessed at the initial ADHD visit for coexisting conditions. Coexisting conditions were found to be present in 20 (33.3%) patients. Of these 20 patients, coexisting conditions were not addressed during the visit in 12 (60%) patients before drug therapy for ADHD was initially prescribed. Behavioral therapy was initiated as first-line monotherapy in one of the nine preschool-age patients (4-5 years old). Fifty-two (86.7%) patients received a preferred initial medication as identified by guidelines, and 41 (78.8%) of those patients received an appropriate initial dose. Fifty-one (85%) patients were assessed for improvement of symptoms, and 39 (65%) were assessed for adverse events. Of 62 documented medication adjustments, 54 (87.1%) adjustments coincided with current practice guidelines. Sixteen (26.7%) patients were referred to mental health specialists. This retrospective review identified areas of strength and weakness for attending physicians and medical residents in the diagnosis, evaluation, and treatment of children with ADHD. A significant need was identified for more physician-focused education on the evaluation of coexisting conditions and long-term management associated with ADHD therapy. Further training in the initiation of behavioral therapy as a first-line treatment above drug therapy and proper medication selection in children aged 4 to 5 years also are recommended.

Emergency recompression: clinical audit of service delivery at a national level.

PubMed

Ross, John As; Sayer, Martin Dj

2009-03-01

Clinical audit is an essential element to the maintenance or improvement of delivery of any medical service. During the development phase of a National Recompression Registration Service for Scotland, clinical audit was initiated to provide a standardised tool to monitor the quality of outcome with respect to the severity of presentation. A functional audit process was an essential consideration for planned future measurement of treatment efficacy at local (single hyperbaric unit) and national (multiple hyperbaric units) scales. The audit process was designed to be undemanding, robust and informative, irrespective of the experience of treatment centre and of the clinician in charge of treatment. The clinical records from 104 cases of divers with decompression illness were used to derive and evaluate measures of severity and clinical outcome that could be used for audit and quality assurance. The various measures of disease severity were examined against clinical outcome and days spent in care after admission to a hyperbaric unit. An initial version of the clinical audit format that was developed from this process is presented.

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.

Comprehensive Clinical Phenotyping & Genetic Mapping for the Discovery of Autism Susceptibility Genes

DTIC Science & Technology

2012-12-05

Bisgaier J, Levinson D, Cutts DB, & Rhodes KV., (2011) Access to autism evaluation appointments with developmental-behavioral and neurodevelopmental ...W403 Columbus, OH 43205 Final Report Comprehensive Clinical Phenotyping & Genetic Mapping for the Discovery of Autism Susceptibility Genes...QFOXGHDUHDFRGH 1.0 Summary In 2006, the Central Ohio Registry for Autism (CORA) was initiated as a collaboration between Wright-Patterson Air

[Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].

PubMed

Renisch, B; Lauer, W

2014-12-01

An integral part of the conformity assessment process for medical devices is a clinical evaluation based on clinical data. Particularly in the case of implantable devices and products of risk class III clinical trials must be performed. Since March 2010 applications for the authorization of clinical trials as well as for the waiver of the authorization requirement must be submitted centrally in Germany to the appropriate federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). In addition to authorization, approval by the responsible ethics committee is also required under law in order to begin clinical testing of medical devices in Germany. In this paper, the legal framework for the clinical testing of medical devices as well as those involved and possible procedures including evaluation criteria for the initial application of a trial and subsequent amendments are presented in detail. In addition, the reporting requirements for serious adverse events (SAEs) are explained and possible consequences of the evaluation are presented. Finally, a summary of application and registration numbers for all areas of extensive experience of the BfArM as well as requests and guidance for applicants are presented.

Organic brain syndrome with psychosis as an initial manifestation of systemic lupus erythematosus in an elderly woman.

PubMed

Mavrikakis, M E; Antoniades, L G; Germanides, J B; Sotou, D; Rassidakis, A

1992-01-01

This paper describes a rare case of organic brain syndrome with psychosis and clinically transverse myelopathy, as initial manifestations of systemic lupus erythematosus in an elderly woman. The identification and evaluation of antibodies to ribosome P in the serum and cerebrospinal fluid may be of help in such cases for differential diagnosis. The patient was treated successfully with 30 mg prednisone daily.

Clinical experience with orthotic repair of pectus carinatum.

PubMed

Al-Githmi, Iskander S

2016-01-01

Pectus carinatum is a congenital chest wall deformity characterized by protrusion of the sternum and adjacent costal cartilages. Multiple treatment options are available for correction of pectus carinatum. We report our initial experience with first-line treatment using a custom fitted dynamic compression orthosis. Prospective evaluation of all patients seen between November 2013 and December 2014. University hospital. The treatment protocol for patients who had pressure for initial correction.

An evaluation of learning clinical decision-making for early rehabilitation in the ICU via interactive education with audience response system.

PubMed

Toonstra, Amy L; Nelliot, Archana; Aronson Friedman, Lisa; Zanni, Jennifer M; Hodgson, Carol; Needham, Dale M

2017-06-01

Knowledge-related barriers to safely implement early rehabilitation programs in intensive care units (ICUs) may be overcome via targeted education. The purpose of this study was to evaluate the effectiveness of an interactive educational session on short-term knowledge of clinical decision-making for safe rehabilitation of patients in ICUs. A case-based teaching approach, drawing from published safety recommendations for initiation of rehabilitation in ICUs, was used with a multidisciplinary audience. An audience response system was incorporated to promote interaction and evaluate knowledge before vs. after the educational session. Up to 175 audience members, of 271 in attendance (129 (48%) physical therapists, 51 (19%) occupational therapists, 31 (11%) nursing, 14 (5%) physician, 46 (17%) other), completed both the pre- and post-test questions for each of the six unique patient cases. In four of six patient cases, there was a significant (p< 0.001) increase in identifying the correct answer regarding initiation of rehabilitation activities. This learning effect was similar irrespective of participants' years of experience and clinical discipline. An interactive, case-based, educational session may be effective for increasing short-term knowledge, and identifying knowledge gaps, regarding clinical decision-making for safe rehabilitation of patients in ICUs. Implications for Rehabilitation Lack of knowledge regarding the safety considerations for early rehabilitation of ICU patients is a barrier to implementing early rehabilitation. Interactive educational formats, such as the use of audience response systems, offer a new method of teaching and instantly assessing learning of clinically important information. In a small study, we have shown that an interactive, case-based educational format may be used to effectively teach clinical decision-making for the safe rehabilitation of ICU patients to a diverse audience of clinicians.

Exceptional Responders Initial Feasibility Results

Cancer.gov

A pilot study evaluating identification of cancer patients who respond to treatment that is ineffective in at least 90 percent of patients found that it was indeed able to confirm a majority of proposed patients as exceptional responders based on clinical

Systematization of Nursing Care in undergraduate training: the perspective of Complex Thinking.

PubMed

da Silva, Josilaine Porfírio; Garanhani, Mara Lucia; Peres, Aida Maris

2015-01-01

to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context.

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.

A prospective pilot study of genome-wide exome and transcriptome profiling in patients with small cell lung cancer progressing after first-line therapy.

PubMed

Weiss, Glen J; Byron, Sara A; Aldrich, Jessica; Sangal, Ashish; Barilla, Heather; Kiefer, Jeffrey A; Carpten, John D; Craig, David W; Whitsett, Timothy G

2017-01-01

Small cell lung cancer (SCLC) that has progressed after first-line therapy is an aggressive disease with few effective therapeutic strategies. In this prospective study, we employed next-generation sequencing (NGS) to identify therapeutically actionable alterations to guide treatment for advanced SCLC patients. Twelve patients with SCLC were enrolled after failing platinum-based chemotherapy. Following informed consent, genome-wide exome and RNA-sequencing was performed in a CLIA-certified, CAP-accredited environment. Actionable targets were identified and therapeutic recommendations made from a pharmacopeia of FDA-approved drugs. Clinical response to genomically-guided treatment was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The study completed its accrual goal of 12 evaluable patients. The minimum tumor content for successful NGS was 20%, with a median turnaround time from sample collection to genomics-based treatment recommendation of 27 days. At least two clinically actionable targets were identified in each patient, and six patients (50%) received treatment identified by NGS. Two had partial responses by RECIST 1.1 on a clinical trial involving a PD-1 inhibitor + irinotecan (indicated by MLH1 alteration). The remaining patients had clinical deterioration before NGS recommended therapy could be initiated. Comprehensive genomic profiling using NGS identified clinically-actionable alterations in SCLC patients who progressed on initial therapy. Recommended PD-1 therapy generated partial responses in two patients. Earlier access to NGS guided therapy, along with improved understanding of those SCLC patients likely to respond to immune-based therapies, should help to extend survival in these cases with poor outcomes.

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.

SU-F-T-433: Evaluation of a New Dose Mimicking Application for Clinical Flexibility and Reliability

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

Hoffman, D; Nair, C Kumaran; Wright, C

2016-06-15

Purpose: Clinical workflow and machine down time occasionally require patients to be temporarily treated on a system other than the initial treatment machine. A new commercial dose mimicking application provides automated cross-platform treatment planning to expedite this clinical flexibility. The aim of this work is to evaluate the feasibility of automatic plan creation and establish a robust clinical workflow for prostate and pelvis patients. Methods: Five prostate and five pelvis patients treated with helical plans were selected for re-planning with the dose mimicking application, covering both simple and complex scenarios. Two-arc VMAT and 7- and 9-field IMRT plans were generatedmore » for each case, with the objective function of achieving similar dose volume histogram from the initial helical plans. Dosimetric comparisons include target volumes and organs at risk (OARs) (rectum, bladder, small bowel, femoral heads, etc.). Dose mimicked plans were evaluated by a radiation oncologist, and patient-specific QAs were performed to validate delivery. Results: Overall plan generation and transfer required around 30 minutes of dosimetrist’s time once the dose-mimicking protocol is setup for each site. The resulting VMAT and 7- and 9-field IMRT plans achieved equivalent PTV coverage and homogeneity (D99/DRx = 97.3%, 97.2%, 97.2% and HI = 6.0, 5.8, and 5.9, respectively), compared to helical plans (97.6% and 4.6). The OAR dose discrepancies were up to 6% in rectum Dmean, but generally lower in bladder, femoral heads, bowel and penile bulb. In the context of 1–5 fractions, the radiation oncologist evaluated the dosimetric changes as not clinically significant. All delivery QAs achieved >90% pass with a 3%/3mm gamma criteria. Conclusion: The automated dose-mimicking workflow offers a strategy to avoid missing treatment fractions due to machine down time with non-clinically significant changes in dosimetry. Future work will further optimize dose mimicking plans and investigate other cross-platform treatment delivery options.« less

Development and Testing of a Single Frequency Terahertz Imaging System for Breast Cancer Detection

PubMed Central

St. Peter, Benjamin; Yngvesson, Sigfrid; Siqueira, Paul; Kelly, Patrick; Khan, Ashraf; Glick, Stephen; Karellas, Andrew

2013-01-01

The ability to discern malignant from benign tissue in excised human breast specimens in Breast Conservation Surgery (BCS) was evaluated using single frequency terahertz radiation. Terahertz (THz) images of the specimens in reflection mode were obtained by employing a gas laser source and mechanical scanning. The images were correlated with optical histological micrographs of the same specimens, and a mean discrimination of 73% was found for five out of six samples using Receiver Operating Characteristic (ROC) analysis. The system design and characterization is discussed in detail. The initial results are encouraging but further development of the technology and clinical evaluation is needed to evaluate its feasibility in the clinical environment. PMID:25055306

Evaluation of radiographic interpretation competence of veterinary students in Finland.

PubMed

Koskinen, Heli I; Snellman, Marjatta

2009-01-01

In the evaluation of the clinical competence of veterinary students, many different definitions and methods are approved. Due to the increasing discussion of the quality of outcomes produced by newly graduated veterinarians, methods for the evaluation of clinical competencies should also be evaluated. In this study, this was done by comparing two qualitative evaluation schemes: the well-known structure of observed learning outcome (SOLO) taxonomy and a modification of this taxonomy. A case-based final radiologic examination was selected and the investigation was performed by classifying students' outcomes. These classes were finally put next to original (quantitative) scores and the statistical calculations were initiated. Significant correlations between taxonomies (0.53) and the modified taxonomy and original scores (0.66) were found and some qualitative similarities between evaluation methods were observed. In addition, some supplements were recommended for the structure of evaluation schemes, especially for the structure of the modified SOLO taxonomy.

Alzheimer's Caregiver Support Online: lessons learned, initial findings and future directions.

PubMed

Glueckauf, Robert L; Loomis, Jeffrey S

2003-01-01

Family caregivers of older adults with progressive dementia (e.g., Alzheimer's disease) are faced with a variety of emotional and behavioral difficulties, such as dealing with persistent, repetitive questions, managing agitation and depression, and monitoring hygiene and self-care activities. Although professional and governmental organizations have called for the creation of community-based education and support programs, most dementia caregivers continue to receive little or no formal instruction in responding effectively to these challenges. The current paper describes the development and implementation of Alzheimer's Caregiver Support Online, a Web- and telephone-based education and support network for caregivers of individuals with progressive dementia. Lessons learned from the first two years of this state-supported initiative are discussed, followed by the findings of a Robert Wood Johnson Foundation-funded strategic marketing initiative and an initial program evaluation of AlzOnline's Positive Caregiving classes. Finally, clinical implications and future directions for program development and evaluation research are proposed.

Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications

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

Acharya, Sahaja; Fischer-Valuck, Benjamin W.; Kashani, Rojano

Purpose: To demonstrate the feasibility of online adaptive magnetic resonance (MR) image guided radiation therapy (MR-IGRT) through reporting of our initial clinical experience and workflow considerations. Methods and Materials: The first clinically deployed online adaptive MR-IGRT system consisted of a split 0.35T MR scanner straddling a ring gantry with 3 multileaf collimator-equipped {sup 60}Co heads. The unit is supported by a Monte Carlo–based treatment planning system that allows real-time adaptive planning with the patient on the table. All patients undergo computed tomography and MR imaging (MRI) simulation for initial treatment planning. A volumetric MRI scan is acquired for each patient atmore » the daily treatment setup. Deformable registration is performed using the planning computed tomography data set, which allows for the transfer of the initial contours and the electron density map to the daily MRI scan. The deformed electron density map is then used to recalculate the original plan on the daily MRI scan for physician evaluation. Recontouring and plan reoptimization are performed when required, and patient-specific quality assurance (QA) is performed using an independent in-house software system. Results: The first online adaptive MR-IGRT treatments consisted of 5 patients with abdominopelvic malignancies. The clinical setting included neoadjuvant colorectal (n=3), unresectable gastric (n=1), and unresectable pheochromocytoma (n=1). Recontouring and reoptimization were deemed necessary for 3 of 5 patients, and the initial plan was deemed sufficient for 2 of the 5 patients. The reasons for plan adaptation included tumor progression or regression and a change in small bowel anatomy. In a subsequently expanded cohort of 170 fractions (20 patients), 52 fractions (30.6%) were reoptimized online, and 92 fractions (54.1%) were treated with an online-adapted or previously adapted plan. The median time for recontouring, reoptimization, and QA was 26 minutes. Conclusion: Online adaptive MR-IGRT has been successfully implemented with planning and QA workflow suitable for routine clinical application. Clinical trials are in development to formally evaluate adaptive treatments for a variety of disease sites.« less

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.

Utility of Liquid Biopsy by Improved PNA-LNA PCR Clamp Method for Detecting EGFR Mutation at Initial Diagnosis of Non-Small-Cell Lung Cancer: Observational Study of 190 Consecutive Cases in Clinical Practice.

PubMed

Ito, Kentaro; Suzuki, Yuta; Saiki, Haruko; Sakaguchi, Tadashi; Hayashi, Kosuke; Nishii, Yoichi; Watanabe, Fumiaki; Hataji, Osamu

2018-03-01

The clinical benefit of liquid biopsy for unselected patients at initial diagnosis has thus far been unclear. We aimed to evaluate the utility of liquid biopsy at initial diagnosis, as well as the efficacy of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) based on liquid biopsy results in clinical practice, using the improved peptide nucleic acid-locked nucleic acid (PNA-LNA) PCR clamp method. We routinely performed liquid biopsy using the improved PNA-LNA PCR clamp method for all patients diagnosed with non-small-cell lung cancer (NSCLC) between June 2015 and October 2016. We retrospectively evaluated the reliability of liquid biopsy based either on clinical stage or between sensitizing EGFR mutation and T790M mutation, and the clinical benefit of EGFR-TKI based on the liquid biopsy results in practice. A total of 244 patients underwent liquid biopsies, with 168 patients tested at diagnosis and 22 tested for T790M after pretreatment of EGFR-TKI. For detecting a sensitizing EGFR mutation, the sensitivity, specificity, positive predictive value, and negative predictive value were 72.7%, 100%, 100%, and 93.7% in the group with advanced-stage NSCLC and 0, 100%, not evaluable, and 70.5% in the group with early-stage NSCLC. The positive predictive value and negative predictive value for T790M were 33.3% and 55.6%, respectively. Fourteen patients in the liquid-positive group and 16 patients in the tissue-positive group received EGFR-TKI. The objective response rates of first- and second-generation EGFR-TKI for the liquid-positive and tissue-positive groups were 90.0% and 90.9%, respectively. There was no significant difference in median progression-free survival between the liquid-positive and tissue-positive groups (P = .839). Patients with early-stage NSCLC should not be candidates for this liquid biopsy method. We recommend tissue biopsy as the preferred initial method of molecular analysis, with the exception of patients who are T790M positive or patients who are unable to tolerate invasive biopsy. Copyright © 2017 Elsevier Inc. All rights reserved.

Implementation and consistency of Heart Team decision-making in complex coronary revascularisation.

PubMed

Pavlidis, Antonis N; Perera, Divaka; Karamasis, Grigoris V; Bapat, Vinayak; Young, Chris; Clapp, Brian R; Blauth, Chris; Roxburgh, James; Thomas, Martyn R; Redwood, Simon R

2016-03-01

A multidisciplinary team (MDT) approach for decision-making in patients with complex coronary artery disease (CAD) is now a class IC recommendation in the European and American guidelines for myocardial revascularisation. The aim of this study was to evaluate the implementation and consistency of Heart Team HT decision-making in complex coronary revascularisation. We prospectively evaluated the data of 399 patients derived from 51 consecutive MDT meetings held in a tertiary cardiac centre. A subset of cases was randomly selected and re-presented with the same clinical data to a panel blinded to the initial outcome, at least 6 months after the initial discussion, in order to evaluate the reproducibility of decision-making. The most common decisions included continued medical management (30%), coronary artery bypass grafting (CABG) (26%) and percutaneous coronary intervention (PCI) (17%). Other decisions, such as further assessment of symptoms or evaluation with further invasive or non-invasive tests were made in 25% of the cases. Decisions were implemented in 93% of the cases. On re-discussion of the same data (n=40) within a median period of 9 months 80% of the initial HT recommendations were successfully reproduced. The Heart Team is a robust process in the management of patient with complex CAD and decisions are largely reproducible. Although outcomes are successfully implemented in the majority of the cases, it is important that all clinical information is available during discussion and patient preference is taken into account. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Care zoning in a psychiatric intensive care unit: strengthening ongoing clinical risk assessment.

PubMed

Mullen, Antony; Drinkwater, Vincent; Lewin, Terry J

2014-03-01

To implement and evaluate the care zoning model in an eight-bed psychiatric intensive care unit and, specifically, to examine the model's ability to improve the documentation and communication of clinical risk assessment and management. Care zoning guides nurses in assessing clinical risk and planning care within a mental health context. Concerns about the varying quality of clinical risk assessment prompted a trial of the care zoning model in a psychiatric intensive care unit within a regional mental health facility. The care zoning model assigns patients to one of 3 'zones' according to their clinical risk, encouraging nurses to document and implement targeted interventions required to manage those risks. An implementation trial framework was used for this research to refine, implement and evaluate the impact of the model on nurses' clinical practice within the psychiatric intensive care unit, predominantly as a quality improvement initiative. The model was trialled for three months using a pre- and postimplementation staff survey, a pretrial file audit and a weekly file audit. Informal staff feedback was also sought via surveys and regular staff meetings. This trial demonstrated improvement in the quality of mental state documentation, and clinical risk information was identified more accurately. There was limited improvement in the quality of care planning and the documentation of clinical interventions. Nurses' initial concerns over the introduction of the model shifted into overall acceptance and recognition of the benefits. The results of this trial demonstrate that the care zoning model was able to improve the consistency and quality of risk assessment information documented. Care planning and evaluation of associated outcomes showed less improvement. Care zoning remains a highly applicable model for the psychiatric intensive care unit environment and is a useful tool in guiding nurses to carry out routine patient risk assessments. © 2013 John Wiley & Sons Ltd.

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.

Increased detection of co-morbidities with evaluation at a dedicated adult Turner syndrome clinic.

PubMed

Vincent, A J; Nguyen, H H; Ranasinha, S; Vollenhoven, B

2017-10-01

Turner syndrome (TS), resulting from complete/partial X chromosomal monosomy, is associated with multiple co-morbidities and increased mortality. Although multidisciplinary management is recommended, TS women's health care is sub-optimal. This study evaluates a multidisciplinary adult TS service. Retrospective cohort study of 82 patients attending the quarterly TS clinic from December 2003 to December 2014. Evaluation included (1) demographics, (2) TS standardized co-morbidity screening, and (3) estrogen therapy use. Data analysis involved frequency statistics, T tests and polychoric correlation analysis. Median age at TS diagnosis was 14 years (range 0-65 years), with 12% of women aged >18 years. Median age at initial consultation was 31 years (range 16-65 years). Only 14% of patients were transition program referrals. XO karyotype occurred in 30%. Primary amenorrhea predominated; however, 37% of TS women were not taking estrogen therapy. The proportion of patients not previously screened (44-76%) and those with positive screening diagnoses (5-53%) varied according to co-morbidity. The mean (± standard deviation) number of co-morbidities identified increased following TS clinic screening (7.0 ± 2.6 post-screening vs. 4.4 ± 2.3 pre-screening; p < 0.0001). Polychoric correlation analysis identified particular co-morbidity groupings (including metabolism-related) and increased co-morbidities with primary amenorrhea. A multidisciplinary adult TS clinic improves health surveillance with increased identification of co-morbidities and initiation of estrogen therapy.

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.

Whittling Down the Wait Time: Exploring Models to Minimize the Delay from Initial Concern to Diagnosis and Treatment of Autism Spectrum Disorder.

PubMed

Gordon-Lipkin, Eliza; Foster, Jessica; Peacock, Georgina

2016-10-01

The process from initial concerns to diagnosis of autism spectrum disorder (ASD) can be a long and complicated process. The traditional model for evaluation and diagnosis of ASD often consists of long wait-lists and evaluations that result in a 2-year difference between the earliest signs of ASD and mean age of diagnosis. Multiple factors contribute to this diagnostic bottleneck, including time-consuming evaluations, cost of care, lack of providers, and lack of comfort of primary care providers to diagnose autism. This article explores innovative clinical models that have been implemented to address this as well as future directions and opportunities. 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

Physiotherapy clinical educators' perspectives on a fitness to practice initiative.

PubMed

Lo, Kristin; Curtis, Heather; Francis-Cracknell, Alison; Maloney, Stephen; Nickson, Wendy; Bearman, Margaret; Keating, Jennifer L

2018-01-01

Health practitioner registration boards require health professionals to evaluate and maintain "fitness to practice" (FTP). This encompasses the professional behavior, clinical competence, and freedom from impairment required for safe and effective service provision. We developed and implemented policies to promote student self-assessment and support of FTP that were pre-emptive and designed to be helpful and sought clinician feedback on this initiative. An innovative student-centered FTP approach was devised with consideration of defensible ethico-legal practice. A survey explored clinical educators' perceptions of the FTP policy and the associated education and support. Closed and open survey questions were analyzed using descriptive statistics, qualitative evaluation, and thematic analysis. Seventy-nine physiotherapy clinical educators from 34 sites across eight Australian health services returned surveys. Educators had positive perceptions of policy components, particularly incorporating professionalism as a hurdle requirement and the attendance and incident reporting policies. The benefits of a student-centered FTP approach included clarity and consistency in managing FTP issues and facilitation of student awareness through active engagement in maintaining their FTP. To our knowledge, this paper is the first to report a comprehensive approach to the range of FTP issues incorporating student self-declaration of issues that may affect desirable progression through clinical placements. The policy and program of education and support are likely to be generalizable to health professional training programs that utilize workplace training.

Addressing culture shock in first year midwifery students: Maximising the initial clinical experience.

PubMed

Cummins, Allison M; Catling, Christine; Hogan, Rosemarie; Homer, Caroline S E

2014-12-01

Many Bachelor of Midwifery students have not had any exposure to the hospital setting prior to their clinical placement. Students have reported their placements are foreign to them, with a specialised confusing 'language'. It is important to provide support to students to prevent culture shock that may lead to them leaving the course. To assist first year midwifery students with the transition into clinical practice by providing a preparatory workshop. An action research project developed resources for a workshop held prior to students' first clinical placement. Four phases were held: Phase one involved holding discussion groups with students returning from clinical practice; Phase two was the creation of vodcasts; Phase three was integration of resources into the clinical subject and phase four was the evaluation and reflection on the action research project. Evaluations of the workshops were undertaken through surveying the students after they returned from their clinical placement. A descriptive analysis of the evaluations was performed. Students rated the workshop, vodcasts and the simulated handover positively. Further recommendations were that complications of labour and birth be included in their first semester as students were unexpectedly exposed to this in their first clinical placement. The students evaluated the workshop positively in reducing the amount of culture shock experienced on the first clinical placement. In addition the students provided further recommendations of strategies that would assist with clinical placement. Copyright © 2014 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

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).

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

PubMed

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

2016-02-01

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

Painless thyroiditis associated to thyroid carcinoma: role of initial ultrasonography evaluation.

PubMed

Valentini, Raisa Bressan; Macedo, Bruno Mussoi de; Izquierdo, Rogério Friedrich; Meyer, Erika Laurini Souza

2016-04-01

Even though it is a rare event, most associations of thyroid carcinoma with subacute thyroiditis described in the literature are related to its granulomatous form (Quervain's thyroiditis). We present a patient with subacute lymphocytic thyroiditis (painless thyroiditis) and papillary thyroid cancer that was first suspected in an initial ultrasound evaluation. A 30-year old female patient who was referred to the emergency room due to hyperthyroidism symptoms was diagnosed with painless thyroiditis established by physical examination and laboratory findings. With the presence of a palpable painless thyroid nodule an ultrasound was prescribed and the images revealed a suspicious thyroid nodule, microcalcification focus in the heterogeneous thyroid parenquima and cervical lymphadenopathy. Fine needle aspiration biopsy was taken from this nodule; cytology was assessed for compatibility with papillary thyroid carcinoma. Postsurgical pathology evaluation showed a multicentric papillary carcinoma and lymphocytic infiltration. Subacute thyroiditis, regardless of type, may produce transitory ultrasound changes that obscure the coexistence of papillary carcinoma. Due to this, initial thyroid ultrasound evaluation should be delayed until clinical recovery. We recommended a thyroid ultrasound exam for initial evaluation of painless thyroiditis, particularly in patients with palpable thyroid nodule. Further cytological examination is recommended in cases presenting with suspect thyroid nodule and/or non-nodular hypoechoic (> 1 cm) or heterogeneous areas with microcalcification focus.

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.

Organic brain syndrome with psychosis as an initial manifestation of systemic lupus erythematosus in an elderly woman.

PubMed Central

Mavrikakis, M E; Antoniades, L G; Germanides, J B; Sotou, D; Rassidakis, A

1992-01-01

This paper describes a rare case of organic brain syndrome with psychosis and clinically transverse myelopathy, as initial manifestations of systemic lupus erythematosus in an elderly woman. The identification and evaluation of antibodies to ribosome P in the serum and cerebrospinal fluid may be of help in such cases for differential diagnosis. The patient was treated successfully with 30 mg prednisone daily. PMID:1540015

Attendance at specialist hepatitis clinics and initiation of antiviral treatment among persons chronically infected with hepatitis C: examining the early impact of Scotland's Hepatitis C Action Plan.

PubMed

McDonald, S A; Hutchinson, S J; Innes, H A; Allen, S; Bramley, P; Bhattacharyya, D; Carman, W; Dillon, J F; Fox, R; Fraser, A; Goldberg, D J; Kennedy, N; Mills, P R; Morris, J; Stanley, A J; Wilks, D; Hayes, P C

2014-05-01

Primary goals of the Hepatitis C Action Plan for Scotland Phase II (May 2008-March 2011) were to increase, among persons chronically infected with the hepatitis C (HCV) virus, attendance at specialist outpatient clinics and initiation on antiviral therapy. We evaluated progress towards these goals by comparing the odds, across time, of (a) first clinic attendance within 12 months of HCV diagnosis (n = 9747) and (b) initiation on antiviral treatment within 12 months of first attendance (n = 5736). Record linkage between the national HCV diagnosis (1996-2009) and HCV clinical (1996-2010) databases and logistic regression analyses were conducted for both outcomes. For outcome (a), 32% and 45% in the respective pre-Phase II (before 1 May 2008) and Phase II periods attended a specialist clinic within 12 months of diagnosis; the odds of attendance within 12 months increased over time (OR = 1.05 per year, 95% CI: 1.04-1.07), but was not significantly greater for persons diagnosed with HCV in the Phase II era, compared with the pre-Phase II era (OR = 1.1, 95% CI: 0.9-1.3), after adjustment for temporal trend. For outcome (b), 13% and 28% were initiated on treatment within 12 months of their first clinic attendance in the pre-Phase II and Phase II periods, respectively. Higher odds of treatment initiation were associated with first clinic attendance in the Phase II (OR = 1.9, 95% CI: 1.5-2.4), compared with the pre-Phase II era. Results were consistent with a positive impact of the Hepatitis C Action Plan on the treatment of chronically infected individuals, but further monitoring is required to confirm a sustained effect. © 2013 John Wiley & Sons Ltd.

ICONE: An International Consortium of Neuro Endovascular Centres.

PubMed

Raymond, J; White, P; Kallmes, D F; Spears, J; Marotta, T; Roy, D; Guilbert, F; Weill, A; Nguyen, T; Molyneux, A J; Cloft, H; Cekirge, S; Saatci, I; Bracard, S; Meder, J F; Moret, J; Cognard, C; Qureshi, A I; Turk, A S; Berenstein, A

2008-06-30

The proliferation of new endovascular devices and therapeutic strategies calls for a prudentand rational evaluation of their clinical benefit. This evaluation must be done in an effective manner and in collaboration with industry. Such research initiative requires organisation a land methodological support to survive and thrive in a competitive environment. We propose the formation of an international consortium, an academic alliance committed to the pursuit of effective neurovascular therapies. Such a consortium would be dedicated to the designand execution of basic science, device developmentand clinical trials. The Consortium is owned and operated by its members. Members are international leaders in neurointerventional research and clinical practice. The Consortium brings competency, knowledge, and expertise to industry as well as to its membership across aspectrum of research initiatives such as: expedited review of clinical trials, protocol development, surveys and systematic reviews; laboratory expertise and support for research design and grant applications to public agencies. Once objectives and protocols are approved, the Consortium provides a stable network of centers capable of timely realization of clinical trials or pre clinical investigations in an optimal environment. The Consortium is a non-profit organization. The potential revenue generated from clientsponsored financial agreements will be redirected to the academic and research objectives of the organization. The Consortium wishes to work inconcert with industry, to support emerging trends in neurovascular therapeutic development. The Consortium is a realistic endeavour optimally structured to promote excellence through scientific appraisal of our treatments, and to accelerate technical progress while maximizing patients' safety and welfare.

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.

The AcCell series 2000 as a support system for training and evaluation in educational and clinical settings.

PubMed

Greening, S E; Grohs, D H; Guidos, B J

1997-01-01

Providing effective training, retraining and evaluation programs, including proficiency testing programs, for cytoprofessionals is a challenge shared by many academic and clinical educators internationally. In cytopathology the quality of training has immediately transferable and critically important impacts on satisfactory performance in the clinical setting. Well-designed interactive computer-assisted instruction and testing programs have been shown to enhance initial learning and to reinforce factual and conceptual knowledge. Computer systems designed not only to promote diagnostic accuracy but to integrate and streamline work flow in clinical service settings are candidates for educational adaptation. The AcCell 2000 system, designed as a diagnostic screening support system, offers technology that is adaptable to educational needs during basic and in-service training as well as testing of screening proficiency in both locator and identification skills. We describe the considerations, approaches and applications of the AcCell 2000 system in education programs for both training and evaluation of gynecologic diagnostic screening proficiency.

Pragmatic Applications of RE-AIM for Health Care Initiatives in Community and Clinical Settings

PubMed Central

Estabrooks, Paul E.

2018-01-01

The RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) planning and evaluation framework has been applied broadly, but users often have difficulty in applying the model because of data collection needs across multiple domains and sources. Questions in the more common “who, what, where, how, when, and why” format may be an effective guide to ensure that individual participants, organization staff, and the perspectives of the setting are considered in planning and evaluation. Such a format can also help users in typical community and clinical settings to identify which outcomes are most valued and to focus limited measurement resources. Translations of RE-AIM that are easy to understand and apply are needed for application in real-world community and clinical settings where research and evaluation resources are limited. The purpose of this article is to provide simplified, pragmatic, user-centered and stakeholder-centered recommendations to increase the use of RE-AIM in community and clinical settings and in translational research. PMID:29300695

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; van der Worp, H Bart; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Moy, Claudia Scala; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2017-02-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

SU-G-TeP2-11: Initial Evaluation of a Novel Split-Filter Dual-Energy CT for Use in Radiation Oncology

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

Miller, J; Huang, J; Szczykutowicz, T

2016-06-15

Purpose: To perform an initial evaluation of a novel split-filter dual-energy CT (DECT) system with the goal of understanding the clinical utility and limitations of the system for radiation therapy. Methods: Several phantoms were imaged using the split-filter DECT technique on the Siemens Edge CT scanner using a range of clinically-relevant doses. The optimum-contrast reconstruction, the mixed reconstruction, and the monoenergetic reconstructions (ranging from 40 keV to 190 keV) were evaluated. Each image was analyzed for CT number accuracy, uniformity, noise, low-contrast visibility (LCV), spatial resolution and geometric distortion. For comparison purposes, all parameters were evaluated on 120 kVp single-energymore » CT (SECT) scans used for treatment planning, as well as, a sequential-scan DECT technique for corresponding doses. Results: For all DECT reconstructions no observable geometric distortion was found. Both the optimal-contrast and mixed images demonstrated slight improvements in LCV and noise when compared to the SECT, and slight reductions in CT number accuracy and spatial resolution. The CT numbers trended as expected for the monoenergetic reconstructions, with CT number accuracy within 50 HU for materials of density <2 g/cm3. Spatial resolution increased with energy, and for monoenergetic reconstructions >70 keV the spatial resolution exceeded that of the SECT. The noise in the monoenergetic reconstructions increased with decreasing energy. Thus, the image uniformity, signal-to-noise ratio and LCV were diminished at lower energies (70 keV). Applying iterative reconstruction techniques to the low-energy images reduced noise and improved LCV. The signal-to-noise ratio was stable for energies >100 keV. Conclusion: The initial commissioning of the novel split-filter DECT technology demonstrated favorable results for clinical implementation. The mixed reconstruction showed potential as a replacement for the treatment planning SECT. The image parameters for the monoenergetic reconstructions varied appropriately with energy. This work provides an initial understanding of the limitations and potential applications for monoenergetic imaging.« less

Asymptomatic proteinuria. Clinical significance.

PubMed

Papper, S

1977-09-01

Patients with asymptomatic proteinuria have varied reasons for the proteinuria and travel diverse courses. In the individual with normal renal function and no systemic cause, ie, idiopathic asymptomatic proteinuria, the outlook is generally favorable. Microscopic hematuria probably raises some degree of question about prognosis. The kidney shows normal glomeruli, subtle changes, or an identifiable lesion. The initial approach includes a clinical and laboratory search for systemic disease, repeated urinalyses, quantitative measurements of proteinuria, determination of creatinine clearance, protein electrophoresis where indicated, and intravenous pyelography. The need for regularly scheduled follow-up evaluation is emphasized. Although the initial approach need not include renal biopsy, a decline in creatinine clearance, an increase in proteinuria, or both are indications for biopsy and consideration of drug therapy.

Measuring the cost implications of the Collaborative Accountable Care initiative in Texas.

PubMed

Ho, Vivian; Allen, Timothy K; Kim, Urie; Keenan, William P; Ku-Goto, Meei-Hsiang; Sanderson, Mark

2016-09-01

We analyzed changes in healthcare spending associated with the implementation of Cigna's Collaborative Accountable Care (CAC) initiative in a large multi-clinic physician practice. We compared claims from 2009, prior to the CAC initiative, against claims for 2010 to 2011, contrasting the patients covered by Cigna's CAC initiative with patients in other practices in the same geographic area covered by Cigna's medical plan. We used a propensity weighted difference-in-differences approach, adjusting for age, sex, health status, and secular trends to isolate the treatment effect of the CAC. The CAC initiative resulted in a 5.7% reduction in net spending per patient for 2010 to 2011, relative to what spending would have been without the initiative. This reduced spending was evident in multiple service categories: evaluation and management, procedures, imaging, tests, and durable medical equipment. Professional payments, inpatient facility, and outpatient facility payments for Medical Clinic of North Texas enrollees all experienced significant cost savings relative to the control group. About half of the savings resulted from using lower-priced sources. The CAC initiative, which includes an embedded care coordinator and a list of recommended providers, was associated with cost savings similar to those reported by other initiatives, such as global budgets and risk-based contracts.

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

Quality of life before hyperhidrosis treatment as a predictive factor for oxybutynin treatment outcomes in palmar and axillary hyperhidrosis.

PubMed

Wolosker, Nelson; Krutman, Mariana; Teivelis, Marcelo P; Campbell, Taiz P D A; Kauffman, Paulo; de Campos, José Ribas M; Puech-Leão, Pedro

2014-05-01

Studies have suggested that quality of life (QOL) evaluation before video-assisted thoracoscopic sympathectomy for patients with hyperhidrosis may serve as a predictive factor for positive postoperative outcomes. Our study aims to analyze if this tendency is also observed in patients treated with oxybutynin for palmar and axillary hyperhidrosis. Five hundred sixty-five patients who submitted to a protocol treatment with oxybutynin were retrospectively analyzed between January 2007 and January 2012 and were divided into 2 groups according to QOL assessment before treatment. The groups consisted of 176 patients with "poor" and 389 patients with "very poor" QOL evaluation before oxybutynin treatment. Outcomes involving improvements in QOL and clinical progression of hyperhidrosis were evaluated using a validated clinical questionnaire that was specifically designed to assess satisfaction in patients with excessive sweating. Improvements in hyperhidrosis after oxybutynin were observed in 65.5% of patients with very poor pretreatment QOL scores and in 75% of patients with poor pretreatment QOL scores, and the only adverse event associated with oxybutynin treatment was dry mouth, which was observed with greater intensity in patients with very poor initial QOL evaluation. Improvements in hyperhidrosis after oxybutynin treatment were similar in both groups, suggesting that QOL before treatment is not a predictive factor for clinical outcomes, contrasting with surgical results that disclose significantly better results in patients with initially poorer QOL analysis. Copyright © 2014 Elsevier Inc. All rights reserved.

Management of children exposed to Mycobacterium tuberculosis: a public health evaluation in West Java, Indonesia.

PubMed

Rutherford, Merrin E; Ruslami, Rovina; Anselmo, Melissa; Alisjahbana, Bachti; Yulianti, Neti; Sampurno, Hedy; van Crevel, Reinout; Hill, Philip C

2013-12-01

To investigate qualitatively and quantitatively the performance of a programme for managing the child contacts of adult tuberculosis patients in Indonesia. A public health evaluation framework was used to assess gaps in a child contact management programme at a lung clinic. Targets for programme performance indicators were derived from established programme indicator targets, the scientific literature and expert opinion. Compliance with tuberculosis screening, the initiation of isoniazid preventive therapy in children younger than 5 years, the accuracy of tuberculosis diagnosis and adherence to preventive therapy were assessed in 755 child contacts in two cohorts. In addition, 22 primary caregivers and 34 clinic staff were interviewed to evaluate knowledge and acceptance of child contact management. The cost to caregivers was recorded. Gaps between observed and target indicator values were quantified. THE GAPS BETWEEN OBSERVED AND TARGET PERFORMANCE INDICATORS WERE: 82% for screening compliance; 64 to 100% for diagnostic accuracy, 50% for the initiation of preventive therapy, 54% for adherence to therapy and 50% for costs. Many staff did not have adequate knowledge of, or an appropriate attitude towards, child contact management, especially regarding isoniazid preventive therapy. Caregivers had good knowledge of screening but not of preventive therapy and had difficulty travelling to the clinic and paying costs. The study identified widespread gaps in the performance of a child contact management system in Indonesia, all of which appear amenable to intervention. The public health evaluation framework used could be applied in other settings where child contact management is failing.

Protocols for the Initial Treatment of Moderately Severe Juvenile Dermatomyositis: Results of a Children's Arthritis and Rheumatology Research Alliance Consensus Conference

PubMed Central

Huber, Adam M.; Giannini, Edward H.; Bowyer, Suzanne L.; Kim, Susan; Lang, Bianca; Lindsley, Carol B.; Pachman, Lauren M.; Pilkington, Clarissa; Reed, Ann M.; Rennebohm, Robert M.; Rider, Lisa G.; Wallace, Carol A.; Feldman, Brian M.

2010-01-01

Objective To use juvenile dermatomyositis (JDM) survey data and expert opinion to develop a small number of consensus treatment protocols which reflect current initial treatment of moderately severe JDM. Methods A consensus meeting was held in Toronto, Ontario, Canada on December 1-2, 2007. Nominal group technique was used to achieve consensus on treatment protocols which represented typical management of moderately severe JDM. Consensus was also reached on which patients these protocols would be applicable to (inclusion and exclusion criteria), initial investigations which should be done prior to initiating one of these protocols, data which should be collected to evaluate these protocols, concomitant interventions that would be required or recommended. Results Three protocols were developed which described the first 2 months of treatment. All protocols included corticosteroids and methotrexate. One protocol also included intravenous gammaglobulin. Consensus was achieved for all issues that were addressed by conference participants, although there were some areas of controversy Conclusions This study shows that it is possible to achieve consensus on the initial treatment of JDM, despite considerable variation in clinical practice. Once these protocols are extended beyond 2 months, these protocols will be available for clinical use. By using methods which account for differences between patients (confounding by indication), the comparative effectiveness of the protocols will be evaluated. In the future, the goal will be to identify the optimal treatment of moderately severe JDM. PMID:20191521

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.

Advances in Retinal Prosthetic Research: A Systematic Review of Engineering and Clinical Characteristics of Current Prosthetic Initiatives.

PubMed

Cheng, Derrick L; Greenberg, Paul B; Borton, David A

2017-03-01

To date, reviews of retinal prostheses have focused primarily on devices undergoing human trials in the Western Hemisphere and fail to capture significant advances in materials and engineering research in countries such as Japan and Korea, as well as projects in early stages of development. To address these gaps, this systematic review examines worldwide advances in retinal prosthetic research, evaluates engineering characteristics and clinical progress of contemporary device initiatives, and identifies potential directions for future research in the field of retinal prosthetics. A literature search using PubMed, Google Scholar, and IEEExplore was conducted following the PRISMA Guidelines for Systematic Review. Inclusion criteria were peer-reviewed papers demonstrating progress in human or animal trials and papers discussing the prosthetic engineering design. For each initiative, a description of the device, its engineering considerations, and recent clinical results were provided. Ten prosthetic initiatives met our inclusion criteria and were organized by stimulation location. Of these initiatives, four have recently completed human trials, three are undergoing multi- or single-center human trials, and three are undergoing preclinical animal testing. Only the Argus II (FDA 2013, CE 2011) has obtained FDA approval for use in the United States; the Alpha-IMS (CE 2013) has achieved the highest visual acuity using a Landolt-C test to date and is the only device presently undergoing a multicenter clinical trial. Several distinct approaches to retinal stimulation have been successful in eliciting visual precepts in animals and/or humans. However, many clinical needs are still not met and engineering challenges must be addressed before a retinal prosthesis with the capability to fully and safely restore functional vision can be realized.

A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design.

PubMed

Khanna, Reena; Bouguen, Guillaume; Feagan, Brian G; DʼHaens, Geert; Sandborn, William J; Dubcenco, Elena; Baker, K Adam; Levesque, Barrett G

2014-10-01

Crohn's disease (CD) is a chronic idiopathic inflammatory disorder of the gastrointestinal tract. Recently, mucosal healing has been proposed as a goal of therapy because clinical symptoms are subjective. Evaluative indices that measure endoscopic disease activity are required to define mucosal healing for clinical trials. The primary objective of this systematic review was to assess the existing evaluative indices that measure disease activity in CD and evaluate their role as outcome measures in clinical trials. A systematic literature review was performed using MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and DDW abstracts to identify randomized controlled trials and controlled clinical trials that used a relevant evaluative index from inception to February 2013. The data obtained from these trials were reviewed and summarized. The initial literature searches identified 2300 citations. After duplicates were removed, 1454 studies remained. After application of the apriori inclusion and exclusion criteria, 109 articles were included and 3 were identified with handsearches. In total, 9 evaluative indices for CD were identified and reviewed. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score in Crohn's Disease (SES-CD) are indices with the most extensively described operating properties. Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for CD. Currently, the CDEIS and SES-CD have the most data regarding operating properties; however, further validation is required.

Nuclear grade and DNA ploidy in stage IV breast cancer with only visceral metastases at initial diagnosis.

PubMed

De Lena, M; Barletta, A; Marzullo, F; Rabinovich, M; Leone, B; Vallejo, C; Machiavelli, M; Romero, A; Perez, J; Lacava, J; Cuevas, M A; Rodriguez, R; Schittulli, F; Paradisco, A

1996-01-01

The presence of early metastases to distant sites in breast cancer patients is an infrequent event whose mechanisms are still not clear. The aim of this study was to evaluate the biologic and clinical role of DNA ploidy and cell nuclear grade of primary tumors in the metastatic process of a series of stage IV previously untreated breast cancer patients with only visceral metastases. DNA flow cytometry analysis on paraffin-embedded material and cell nuclear grading of primary tumors was performed on a series of 50 breast cancer patients with only visceral metastases at the time of initial diagnosis. Aneuploidy was found in 28/46 (61%) of evaluable cases and was independent of site of involvement, clinical response, time of progression and overall survival of patients. Of the 46 cases evaluable for nuclear grade, 5 (11%), 16 (35%) and 25 (54%) were classified as G1 (well-differentiated) G2 and G3, respectively. Nuclear grade also was unrelated to response to therapy and overall survival, whereas time to progression was significantly longer in G1-2 than G3 tumors with the logrank test (P < 0.03) and multivariate analysis. Our results seem to stress the difficulty to individualize different prognostic subsets from a series of breast cancer patients with only visceral metastases at initial diagnosis according to DNA flow cytometry and nuclear grade.

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.

Systematization of Nursing Care in undergraduate training: the perspective of Complex Thinking 1

PubMed Central

da Silva, Josilaine Porfírio; Garanhani, Mara Lucia; Peres, Aida Maris

2015-01-01

AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806632

Pharmacogenetics and personalised medicine: maintain a critical approach.

PubMed

2013-06-01

The purpose of pharmacogenetics is to offer"personalised" treatment, in which a drug is only prescribed to patients in whom it is very likely to be effective, or to withhold a drug from patients at increased risk of adverse effects. Pharmacogenetics requires the use of genetic tests which, as with any other diagnostic test, must be evaluated for their discriminatory power (sensitivity, specificity, etc.). These evaluations are sometimes biased. Pharmacogenetics has been heralded as a means of tailoring cancer therapy. However large clinical trials with demanding clinical endpoints are often disappointing, despite initially encouraging results. Pharmacogenetic information is included in many summaries of product characteristics for non-cancer drugs, mainly in order to reduce the frequency of certain serious adverse effects. In summary, pharmacogenetics theoretically represents a step forward but must be evaluated in rigorous clinical trials, as is the case with all other "therapeutic tools".

Experimental Evaluation of Behavioral Activation Treatment of Anxiety (BATA) in Three Older Adults

ERIC Educational Resources Information Center

Turner, Jarrod S.; Leach, David J.

2010-01-01

This report describes three single-case experimental evaluations of Behavioral Activation Treatment of Anxiety (BATA) applied with a 51-year-old male, a 62-year-old female, and a 53-year-old female, each of whom met DSM-IV criteria for anxiety. Each case was a clinical replication of an initial trial of BATA reported in Turner and Leach (2009).…

Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Henley, Jill K; Ashchyan, Hovik J; Kurta, Anastasia O; Patel, Payal M; Sheikh, Umar A; Franklin, Matthew J; Hanna, Courtney C; Chen, Brian R; Chiren, Sarah G; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Maher, Ian A; Cartee, Todd V; Sobanko, Joseph F; Alam, Murad

2017-08-01

Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28 July 2016.

Clinical and economic impact of remote monitoring on the follow-up of patients with implantable electronic cardiovascular devices: an observational study.

PubMed

Costa, Paulo Dias; Reis, A Hipólito; Rodrigues, Pedro P

2013-02-01

Traditional follow-up of patients with cardiovascular devices is still an activity that, in addition to serving an increasing population, requires a considerable amount of time and specialized human and technical resources. Our aim was to evaluate the applicability of the CareLink(®) (Medtronic, Minneapolis, MN) remote monitoring system as a complementary option to the follow-up of patients with implanted devices, between in-office visits. Evaluated outcomes included both clinical (event detection and time to diagnosis) and nonclinical (patient's satisfaction and economic costs) aspects. An observational, longitudinal, prospective study was conducted with patients from a Portuguese central hospital sampled by convenience during 1 week (43 patients). Data were collected in four moments: two in-office visits and two remote evaluations, reproducing 1 year of clinical follow-up. Data sources included health records, implant reports, initial demographic data collection, follow-up printouts, and a questionnaire. After selection criteria were verified, 15 patients (11 men [73%]) were included, 63.4±10.8 years old, representing 14.0±6.3 implant months. Clinically, 15 events were detected (9 by remote monitoring and 6 by patient-initiated activation), of which only 9 were symptomatic. We verified that remote monitoring could detect both symptomatic and asymptomatic events, whereas patient-initiated activation only detected symptomatic ones (p=0.028). Moreover, the mean diagnosis anticipation in patients with events was approximately 58 days (p<0.001). In nonclinical terms, we observed high or very high satisfaction (67% and 33%, respectively) with using remote monitoring technology, but still 8 patients (53%) stated they preferred in-office visits. Finally, the introduction of remote monitoring technology has the ability to reduce total follow-up costs for patients by 25%. We conclude that the use of this system constitutes a viable complementary option to the follow-up of patients with implantable devices, between in-office visits.

Evaluation of compliance with osteoporosis treatment guidelines after initiation of a pharmacist-run osteoporosis service at a family medicine clinic.

PubMed

Hall, Larissa N; Shrader, Sarah P; Ragucci, Kelly R

2009-11-01

Osteoporosis affects more than 10 million Americans, and fracture complications are devastating to patients and society. Despite the availability of guidelines and performance measures, osteoporosis is not optimally managed. Pharmacists have been pivotal in management of other disease states, and a multidisciplinary approach to osteoporosis management may improve patient outcomes. To establish a pharmacist-run osteoporosis service at a family medicine clinic and to evaluate short-term compliance with osteoporosis treatment guidelines before and after initiation of the service. A pharmacist-run osteoporosis service was established in October 2008. Adults with the diagnosis of osteoporosis before initiation of the service were included in evaluation of short-term compliance with treatment guidelines, including appropriate dual-energy X-ray absorptiometry (DEXA) scan frequency, pharmacotherapy, calcium and vitamin D supplementation, and nonpharmacologic education. Of 42 referred patients, 22 were eligible for inclusion. A retrospective chart review was conducted, and patients served as their own controls, with data from before and after establishment of the service evaluated. Of the 22 patients evaluated, 8 (36%) received DEXA scans at the appropriate frequency before the service was established, versus 18 (82%) after the service was initiated. Seven (32%) patients were taking appropriate pharmacotherapy before the service, versus 17 (77%) after the service. Nine (41%) patients were taking calcium and vitamin D before the service, versus 22 (100%) after the service. Three (33%) of these patients were taking the appropriate dose and salt of calcium before the service, versus 20 (91%) after the service. Five (56%) of the 9 patients were taking the appropriate vitamin D dose before the service, versus 21 (95%) after the service. No patient had documented nonpharmacologic education prior to the service, compared with all patients after the service. All differences were significant (p < 0.05). A pharmacist-run osteoporosis service significantly improved short-term compliance with guidelines, including appropriate DEXA scan frequency, pharmacotherapy, calcium and vitamin D supplementation, and nonpharmacologic education.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

PubMed

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

A universal genetic testing initiative for patients with high-grade, non-mucinous epithelial ovarian cancer and the implications for cancer treatment.

PubMed

Bednar, Erica M; Oakley, Holly D; Sun, Charlotte C; Burke, Catherine C; Munsell, Mark F; Westin, Shannon N; Lu, Karen H

2017-08-01

Genetic counseling (GC) and germline genetic testing (GT) for BRCA1 and BRCA2 are considered standard of care for patients with high-grade, non-mucinous epithelial ovarian, fallopian tube, and primary peritoneal cancers (HGOC). We describe a universal genetic testing initiative to increase the rates of recommendation and acceptance of GC and GT to >80% for patients with HGOC at our institution. Data from a consecutive cohort of patients seen in our gynecologic oncology clinics between 9/1/2012 and 8/31/2015 for evaluation of HGOC were retrospectively analyzed. Data were abstracted from the tumor registry, medical records, and research databases. Descriptive statistics were used to evaluate patient characteristics and GC, GT, and PARP inhibitor use. Various clinic interventions were developed, influenced by the Plan-Do-Study-Act cycle method, which included physician-coordinated GT, integrated GC, and assisted GC referrals. A cohort of 1636 patients presented to the gynecologic oncology clinics for evaluation of HGOC during our study period, and 1423 (87.0%) were recommended to have GC and GT. Of these, 1214 (85.3%) completed GT and 217 (17.9%) were found to have a BRCA1 or BRCA2 mutation. Among BRCA-positive patients, 167 had recurrent or progressive disease, and 56 of those received PARP inhibitor therapy. The rates of GC and GT recommendation and completion among patients with HGOC at our institution exceeded 80% following the implementation of a universal genetic testing initiative. Universal genetic testing of patients with HGOC is one strategy to identify those who may benefit from PARP inhibitor therapy. Copyright © 2017. Published by Elsevier Inc.

Hospital-Based Clinical Pharmacy Services to Improve Ambulatory Management of Chronic Obstructive Pulmonary Disease

PubMed Central

Smith, Amber Lanae; Palmer, Valerie; Farhat, Nada; Kalus, James S.; Thavarajah, Krishna; DiGiovine, Bruno; MacDonald, Nancy C.

2016-01-01

Background: No systematic evaluations of a comprehensive clinical pharmacy process measures currently exist to determine an optimal ambulatory care collaboration model for chronic obstructive pulmonary disease (COPD) patients. Objective: Describe the impact of a pharmacist-provided clinical COPD bundle on the management of COPD in a hospital-based ambulatory care clinic. Methods: This retrospective cohort analysis evaluated patients with COPD managed in an outpatient pulmonary clinic. The primary objective of this study was to assess the completion of 4 metrics known to improve the management of COPD: (1) medication therapy management, (2) quality measures including smoking cessation and vaccines, (3) patient adherence, and (4) patient education. The secondary objective was to evaluate the impact of the clinical COPD bundle on clinical and economic outcomes at 30 and 90 days post–initial visit. Results: A total of 138 patients were included in the study; 70 patients served as controls and 68 patients received the COPD bundle from the clinical pharmacist. No patients from the control group had all 4 metrics completed as documented, compared to 66 of the COPD bundle group (P < .0001). Additionally, a statistically significant difference was found in all 4 metrics when evaluated individually. Clinical pharmacy services reduced the number of phone call consults at 90 days (P = .04) but did not have a statistically significant impact on any additional pre-identified clinical outcomes. Conclusion: A pharmacist-driven clinical COPD bundle was associated with significant increases in the completion and documentation of 4 metrics known to improve the outpatient management of COPD.

[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.

Initial Clinical Trial of Robot of Endovascular Treatment with Force Feedback and Cooperating of Catheter and Guidewire.

PubMed

Jiang, Yuhua; Liu, Keyun; Li, Youxiang

2018-01-01

To evaluate the feasibility and safety of the robot of endovascular treatment (RobEnt) in clinical practice, we carried out a cerebral angiography using this robot system. We evaluated the performance of application of the robot system to clinical practice through using this robotic system to perform the digital subtraction angiography for a patient who was suspected of suffering intracranial aneurysm. At the same time, through comparing the postoperative head nuclear magnetic and blood routine with the preoperative examination, we evaluated the safety of application of the robot system to clinical practice. We performed the robot system to complete the bilateral carotid artery and bilateral vertebral arteriography. The results indicate that there was no obvious abnormality in the patient's cerebral artery. No obvious abnormality was observed in the examination of patients' check-up, head nuclear magnetism, and blood routine after the digital subtraction angiography. From this clinical trial, it can be observed that the robot system can perform the operation of cerebral angiography. The robot system can basically complete the related observation indexes, and its accuracy, effectiveness, stability, and safety basically meet the requirements of clinical application in neurointerventional surgery.

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.

A prospective pilot study of genome-wide exome and transcriptome profiling in patients with small cell lung cancer progressing after first-line therapy

PubMed Central

Byron, Sara A.; Aldrich, Jessica; Sangal, Ashish; Barilla, Heather; Kiefer, Jeffrey A.; Carpten, John D.; Craig, David W.; Whitsett, Timothy G.

2017-01-01

Background Small cell lung cancer (SCLC) that has progressed after first-line therapy is an aggressive disease with few effective therapeutic strategies. In this prospective study, we employed next-generation sequencing (NGS) to identify therapeutically actionable alterations to guide treatment for advanced SCLC patients. Methods Twelve patients with SCLC were enrolled after failing platinum-based chemotherapy. Following informed consent, genome-wide exome and RNA-sequencing was performed in a CLIA-certified, CAP-accredited environment. Actionable targets were identified and therapeutic recommendations made from a pharmacopeia of FDA-approved drugs. Clinical response to genomically-guided treatment was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Results The study completed its accrual goal of 12 evaluable patients. The minimum tumor content for successful NGS was 20%, with a median turnaround time from sample collection to genomics-based treatment recommendation of 27 days. At least two clinically actionable targets were identified in each patient, and six patients (50%) received treatment identified by NGS. Two had partial responses by RECIST 1.1 on a clinical trial involving a PD-1 inhibitor + irinotecan (indicated by MLH1 alteration). The remaining patients had clinical deterioration before NGS recommended therapy could be initiated. Conclusions Comprehensive genomic profiling using NGS identified clinically-actionable alterations in SCLC patients who progressed on initial therapy. Recommended PD-1 therapy generated partial responses in two patients. Earlier access to NGS guided therapy, along with improved understanding of those SCLC patients likely to respond to immune-based therapies, should help to extend survival in these cases with poor outcomes. PMID:28586388

Risk factors for incidence and severity of white spot lesions during treatment with fixed orthodontic appliances.

PubMed

Chapman, Joshua A; Roberts, W Eugene; Eckert, George J; Kula, Katherine S; González-Cabezas, Carlos

2010-08-01

The development of incipient caries, or white spot lesions (WSLs), is a significant clinical problem in orthodontics. The purpose of this study was to retrospectively determine the incidence and severity of WSLs by examining pretreatment and posttreatment digital photographs. A total of 332 consecutive finished patients from a university graduate orthodontic clinic were evaluated. Initial and final digital images were compared to assess WSLs. The facial surfaces of the anterior 8 maxillary teeth were analyzed. The percentage area of WSL per total facial tooth surface was calculated to control for magnification differences. Reliability of the method was assessed by comparison with direct clinical examination data. Patient and operator factors, and treatment complexity and outcomes were evaluated as predictors of WSL incidence and severity. Agreement between direct clinical examination and digital photo data was excellent, with an intraclass correlation coefficient 0.88 and a 0.3% average difference between methods. The incidence of at least 1 WSL on the labial surface of the anterior 8 maxillary teeth was 36%. The order of incidence was lateral incisor (34%), canine (31%), premolar (28%), and central incisor (17%). Risk factors for the development of incipient caries during orthodontic treatment were young age (preadolescent) at the start of treatment, number of poor hygiene citations during treatment, unfavorable clinical outcome score, white ethnic group, and inadequate oral hygiene at the initial pretreatment examination. The use of computer software to evaluate digital photos retrospectively is a valid method for assessing the incidence and severity of WSLs on the maxillary anterior incisors, canines, and premolars. Copyright (c) 2010 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Classroom to Clinic: Merging Education and Research to Efficiently Prototype Medical Devices

PubMed Central

Begg, Nikolai D.; Walsh, Conor; Custer, David; Gupta, Rajiv; Osborn, Lynn R.; Slocum, Alexander H.

2013-01-01

Innovation in patient care requires both clinical and technical skills, and this paper presents the methods and outcomes of a nine-year, clinical-academic collaboration to develop and evaluate new medical device technologies, while teaching mechanical engineering. Together, over the course of a single semester, seniors, graduate students, and clinicians conceive, design, build, and test proof-of-concept prototypes. Projects initiated in the course have generated intellectual property and peer-reviewed publications, stimulated further research, furthered student and clinician careers, and resulted in technology licenses and start-up ventures. PMID:27170859

Classroom to Clinic: Merging Education and Research to Efficiently Prototype Medical Devices.

PubMed

Hanumara, Nevan C; Begg, Nikolai D; Walsh, Conor; Custer, David; Gupta, Rajiv; Osborn, Lynn R; Slocum, Alexander H

2013-01-01

Innovation in patient care requires both clinical and technical skills, and this paper presents the methods and outcomes of a nine-year, clinical-academic collaboration to develop and evaluate new medical device technologies, while teaching mechanical engineering. Together, over the course of a single semester, seniors, graduate students, and clinicians conceive, design, build, and test proof-of-concept prototypes. Projects initiated in the course have generated intellectual property and peer-reviewed publications, stimulated further research, furthered student and clinician careers, and resulted in technology licenses and start-up ventures.

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.

Development and initial evaluation of the Clinical Information Systems Success Model (CISSM).

PubMed

Garcia-Smith, Dianna; Effken, Judith A

2013-06-01

Most clinical information systems (CIS) today are technically sound, but the number of successful implementations of these systems is low. The purpose of this study was to develop and test a theoretically based integrated CIS Success Model (CISSM) from the nurse perspective. Model predictors of CIS success were taken from existing research on information systems acceptance, user satisfaction, use intention, user behavior and perceptions, as well as clinical research. Data collected online from 234 registered nurses in four hospitals were used to test the model. Each nurse had used the Cerner Power Chart Admission Health Profile for at least 3 months. Psychometric testing and factor analysis of the 23-item CISSM instrument established its construct validity and reliability. Initial analysis showed nurses' satisfaction with and dependency on CIS use predicted their perceived CIS use Net Benefit. Further analysis identified Social Influence and Facilitating Conditions as other predictors of CIS user Net Benefit. The level of hospital CIS integration may account for the role of CIS Use Dependency in the success of CIS. Based on our experience, CISSM provides a formative as well as summative tool for evaluating CIS success from the nurse's perspective. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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.

Behavioral Marital Bibliotherapy: An Initial Investigation of Therapeutic Efficacy.

ERIC Educational Resources Information Center

Bornstein, Philip H.; And Others

1984-01-01

Reports an attempt to validate a self-help behavioral marital bibliotherapy program. Evaluated five clinical distressed couples via a multiple baseline analysis. Treatment involved reading and exercises covering communications, problem solving, and sexual dysfunction. Results were highly variable and reflected minimal change. (BH)

Welcome to EDRN — EDRN Public Portal

Cancer.gov

The Early Detection Research Network (EDRN), an initiative of the National Cancer Institute (NCI), brings together dozens of institutions to help accelerate the translation of biomarker information into clinical applications and to evaluate new ways of testing cancer in its earliest stages and for cancer risk.

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.

Nursing clinical developments units--A strategy to promote the relationship between practice and academia.

PubMed

Happell, Brenda

2006-05-01

Bridging the theory-practice gap has historically been acknowledged as a priority for the nursing profession. Enhancing nurses' attitudes regarding the relevance of theory to practice has been considered as crucial in order that the relationship between theory and practice becomes strong and complimentary. A review of the literature suggests that strategies such as joint clinical and academic positions have not had a significant impact in this respect. Nursing Clinical Development Units (NCDUs) were introduced in the United Kingdom as an initiative to promote the recognition and utilisation of research findings as an inherent component of nursing practice. However, there is limited literature addressing the impact of NCDUs on relationships between academia and the clinical field. The aim of this paper is to present the findings of a qualitative evaluation conducted with participants (n=14) of an NCDU program in Victoria, Australia. The findings suggest that this initiative can significantly enhance relationships with, and attitudes towards, academia.

Is it possible to preserve lumbar lordosis after hybrid stabilization? Preliminary results of a novel rigid-dynamic stabilization system in degenerative lumbar pathologies.

PubMed

Formica, Matteo; Cavagnaro, Luca; Basso, Marco; Zanirato, Andrea; Felli, Lamberto; Formica, Carlo

2015-11-01

To evaluate the results of a novel rigid-dynamic stabilization technique in lumbar degenerative segment diseases (DSD), expressly pointing out the preservation of postoperative lumbar lordosis (LL). Forty-one patients with one level lumbar DSD and initial disc degeneration at the adjacent level were treated. Circumferential lumbar arthrodesis and posterior hybrid instrumentation were performed to preserve an initial disc degeneration above the segment that has to be fused. Clinical and spino-pelvic parameters were evaluated pre- and postoperatively. At 2-year follow-up, a significant improvement of clinical outcomes was reported. No statistically significant difference was noted between postoperative and 2-year follow-up in LL and in disc/vertebral body height ratio at the upper adjacent fusion level. When properly selected, this technique leads to good results. A proper LL should be achieved after any hybrid stabilization to preserve the segment above the fusion.

Futility of fluorodeoxyglucose F 18 positron emission tomography in initial evaluation of patients with T2 to T4 melanoma.

PubMed

Clark, Paige B; Soo, Victoria; Kraas, Jonathan; Shen, Perry; Levine, Edward A

2006-03-01

Evaluation of newly diagnosed patients with melanoma for metastasis is requisite to treatment planning. The reported diagnostic yield of whole-body conventional radiological imaging in initial staging of patients with melanoma is low. However, the diagnostic yield of positron emission tomography (PET) for distant metastases is unclear. There is no utility of PET as part of a routine metastatic survey in patients with T2 to T4 melanoma. Retrospective review of a cohort study between December 1998 and July 2004. University hospital tertiary care center. There were 64 patients with T2 to T4 melanomas who underwent PET for detection of occult metastases at our institution. All patients underwent surgical excision of the primary lesion and sentinel lymph node dissection. Data included were pathologic findings of the primary lesion and sentinel lymph nodes, laboratory data, and radiological reports. None of the patients had clinically suspected regional or distant metastases prior to PET. The diagnostic yield of PET was evaluated through retrospective analysis. Positive scans were then correlated for accuracy with follow-up imaging, biopsy, and clinical information when available. Positron emission tomography did not reveal occult distant metastases in any of the patients. Positron emission tomographic scans showed no abnormalities in 94% of these patients. In 2 patients (3%), false-positive findings were reported on PET (muscular activity and intranodal melanocytic nevocellular inclusion). Further, PET was not useful in predicting regional lymph node metastases. Nineteen of 64 patients had positive sentinel lymph nodes, and only 2 (11%) were identified on PET. Overall, PET did not change clinical management in any of the patients. This study suggests no utility for PET in the detection of occult metastases in patients at initial diagnosis of melanoma. Omission of PET imaging from preoperative evaluations for patients with melanoma is recommended.

Size of clinical trials and Introductory prices of prophylactic vaccine series

PubMed Central

Weinberg, Steven H.; Butchart, Amy T.; Davis, Matthew M.

2012-01-01

Costs of completing the recommended immunization schedule have increased over the last decade. Access to prophylactic vaccines may become limited due to financing obstacles within current delivery systems. Vaccine prices reflect research and development expenses incurred by vaccine manufacturers, including costs associated with evaluating candidate vaccines in human subjects. If the number of subjects in clinical trials is increasing over time and associated with vaccine price, this may help explain increases in prices of vaccine series. We examined whether: (A) the initial public- and private-sector prices for recommended prophylactic vaccine series licensed and recommended in the US increased from 2000–2011, (B) the number of human subjects per licensed vaccine increased during the time period, and (C) the number of human subjects was associated with the initial public–and private–sector prices of the vaccine series. In regression analyses of 13 vaccines, approval year was not significantly associated with the number of human subjects, initial public-sector prices, or initial private-sector prices. While the number of phase II subjects was not significantly associated with prices, the numbers of phase III and combined late phase (phases II + III) subjects were significantly associated with initial public- and private-sector series prices (p < 0.05). The association between number of subjects and initial prices demonstrated diminishing marginal increases in price with increasing numbers of subjects. These findings may help guide the number of subjects required by the FDA in clinical trials, in order to reduce expenses for manufacturers and thereby help mitigate increases in initial vaccine series prices. PMID:22854668

Size of clinical trials and Introductory prices of prophylactic vaccine series.

PubMed

Weinberg, Steven H; Butchart, Amy T; Davis, Matthew M

2012-08-01

Costs of completing the recommended immunization schedule have increased over the last decade. Access to prophylactic vaccines may become limited due to financing obstacles within current delivery systems. Vaccine prices reflect research and development expenses incurred by vaccine manufacturers, including costs associated with evaluating candidate vaccines in human subjects. If the number of subjects in clinical trials is increasing over time and associated with vaccine price, this may help explain increases in prices of vaccine series. We examined whether: (A) the initial public- and private-sector prices for recommended prophylactic vaccine series licensed and recommended in the US increased from 2000-2011, (B) the number of human subjects per licensed vaccine increased during the time period, and (C) the number of human subjects was associated with the initial public-and private-sector prices of the vaccine series. In regression analyses of 13 vaccines, approval year was not significantly associated with the number of human subjects, initial public-sector prices, or initial private-sector prices. While the number of phase II subjects was not significantly associated with prices, the numbers of phase III and combined late phase (phases II + III) subjects were significantly associated with initial public- and private-sector series prices (p < 0.05). The association between number of subjects and initial prices demonstrated diminishing marginal increases in price with increasing numbers of subjects. These findings may help guide the number of subjects required by the FDA in clinical trials, in order to reduce expenses for manufacturers and thereby help mitigate increases in initial vaccine series prices.

An Augmented SMS Intervention to Improve Access to Antenatal CD4 Testing and ART Initiation in HIV-Infected Pregnant Women: A Cluster Randomized Trial

PubMed Central

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

Background 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. Methods 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. Results 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). Conclusions 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. PMID:25693050

A case report using the mental state examination scale (MSES): a tool for measuring change in mental state.

PubMed

Fernando, Irosh; Carter, Gregory

2016-02-01

There is a need for a simple and brief tool that can be used in routine clinical practice for the quantitative measurement of mental state across all diagnostic groups. The main utilities of such a tool would be to provide a global metric for the mental state examination, and to monitor the progression over time using this metric. We developed the mental state examination scale (MSES), and used it in an acute inpatient setting in routine clinical work to test its initial feasibility. Using a clinical case, the utility of MSES is demonstrated in this paper. When managing the patient described, the MSES assisted the clinician to assess the initial mental state, track the progress of the recovery, and make timely treatment decisions by quantifying the components of the mental state examination. MSES may enhance the quality of clinical practice for clinicians, and potentially serve as an index of universal mental healthcare outcome that can be used in clinical practice, service evaluation, and healthcare economics. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Targeting practitioners: A review of guidelines, training, and policy in pain management

PubMed Central

Barth, Kelly S.; Guille, Constance; McCauley, Jenna; Brady, Kathleen T.

2017-01-01

This paper reviews the current literature on clinical guidelines, practitioner training, and government/payer policies that have come forth in response to the national rise in prescription opioid overdoses. A review of clinical opioid prescribing guidelines highlights the need for more research on safe and effective treatment options for chronic pain, improved guidance for the best management of post-operative pain, and evaluation of the implementation and impact of guideline recommendations on patient risk and outcomes. Although there is increasing attention to training in pain management in medical schools and medical residency programs, educational opportunities remain highly variable, and the need for additional clinician training in the recognition and treatment of pain as well as opioid use disorder has been recognized. Mandated use of private, federal and state educational and clinical initiatives such as Risk Evaluation and Mitigation Strategies (REMS) and Prescription Drug Monitoring Programs (PDMPs) generally increase utilization of these initiatives, but more research is needed to determine the impact of these initiatives on provider behaviors, treatment access, and patient outcomes. Finally, there is an acute need for more research on safe and effective treatments for chronic pain as well as an increased multi-level focus on improving training and access to evidence-based treatment for opioid use disorder as well as non-pharmacologic and non-interventional chronic pain treatments, so that these guideline-recommended interventions can become mainstream, accessible, first-line interventions for chronic pain and/or opioid use disorders. PMID:28363316

Scalp Metastasis as the First Sign of Small-Cell Lung Cancer: Management and Literature Review

PubMed Central

Salemis, Nikolaos S.; Veloudis, Georgios; Spiliopoulos, Kyriakos; Nakos, Georgios; Vrizidis, Nikolaos; Gourgiotis, Stavros

2014-01-01

Cutaneous metastasis from primary visceral malignancy is a relatively uncommon clinical entity, with a reported incidence ranging from 0.22% to 10% among various series. However, the presence of cutaneous metastasis as the first sign of a clinically silent visceral cancer is exceedingly rare. We describe here a case of an asymptomatic male patient who presented with a solitary scalp metastasis as the initial manifestation of an underlying small-cell lung cancer. Diagnostic evaluation revealed advanced disease. We conclude that the possibility of metastatic skin disease should always be considered in the differential diagnosis in patients with a history of smoking or lung cancer presenting with cutaneous nodules. Physicians should be aware of this rare clinical entity, and appropriate investigation should be arranged for early diagnosis and initiation of the appropriate treatment. The prognosis for most patients remains poor. PMID:25058760

Scalp metastasis as the first sign of small-cell lung cancer: management and literature review.

PubMed

Salemis, Nikolaos S; Veloudis, Georgios; Spiliopoulos, Kyriakos; Nakos, Georgios; Vrizidis, Nikolaos; Gourgiotis, Stavros

2014-01-01

Cutaneous metastasis from primary visceral malignancy is a relatively uncommon clinical entity, with a reported incidence ranging from 0.22% to 10% among various series. However, the presence of cutaneous metastasis as the first sign of a clinically silent visceral cancer is exceedingly rare. We describe here a case of an asymptomatic male patient who presented with a solitary scalp metastasis as the initial manifestation of an underlying small-cell lung cancer. Diagnostic evaluation revealed advanced disease. We conclude that the possibility of metastatic skin disease should always be considered in the differential diagnosis in patients with a history of smoking or lung cancer presenting with cutaneous nodules. Physicians should be aware of this rare clinical entity, and appropriate investigation should be arranged for early diagnosis and initiation of the appropriate treatment. The prognosis for most patients remains poor.

A clinical report demonstrating the significance of distinguishing a nasopalatine duct cyst from a radicular cyst

PubMed Central

Aparna, Manikkath; Chakravarthy, Arumugam; Acharya, Shashi Rashmi; Radhakrishnan, Raghu

2014-01-01

Endodontic diagnosis is challenging and depends on the organisation of information from the patient history, clinical examination and analysis of the pulp, radiographic and histopathological assessment. A 35-year-old man was endodontically treated for radiolucency in relation to the roots of maxillary central incisors as it was a provisionally diagnosed case of radicular cyst. Since the palatal swelling persisted, the lesion was re-evaluated using relevant diagnostic aids and a diagnosis of nasopalatine duct cyst (NPDC) was made, which was missed during the initial assessment. An erroneous interpretation of cystic radiolucency in relation to maxillary central incisors can often lead to inappropriate treatment planning. This case highlights the relevant aspects in the diagnosis of NPDC when it is mistaken for a radicular cyst and emphasises the need for thorough clinical examination and relevant investigations for periapical radiolucencies of questionable origin before initiating endodontic therapy. PMID:24642171

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment.

PubMed

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm; Nielsen, Michael Bachmann; Jensen, Jorgen Arendt

2017-01-01

This paper discusses the methods for the assessment of ultrasound image quality based on our experiences with evaluating new methods for anatomic imaging. It presents a methodology to ensure a fair assessment between competing imaging methods using clinically relevant evaluations. The methodology is valuable in the continuing process of method optimization and guided development of new imaging methods. It includes a three phased study plan covering from initial prototype development to clinical assessment. Recommendations to the clinical assessment protocol, software, and statistical analysis are presented. Earlier uses of the methodology has shown that it ensures validity of the assessment, as it separates the influences between developer, investigator, and assessor once a research protocol has been established. This separation reduces confounding influences on the result from the developer to properly reveal the clinical value. This paper exemplifies the methodology using recent studies of synthetic aperture sequential beamforming tissue harmonic imaging.

The dissemination of clinical practice guidelines over an intranet: an evaluation.

PubMed Central

Stolte, J. J.; Ash, J.; Chin, H.

1999-01-01

This study compares two clinical practice guideline dissemination systems. It was hypothesized that placing guidelines on an intranet would make this information easier to retrieve. Retrieval time, retrieval accuracy, and ease of use were empirically evaluated. Sixteen clinicians from Kaiser Permanente volunteered to complete tasks that measured these variables. Time values were significantly longer for tasks completed with intranet guidelines (Intranet = 6.7 minutes, Paper = 5.7 minutes). Tasks completed with paper guidelines had a significantly higher percentage of perfect scores than those completed with the intranet (Paper = 85%, Intranet = 59%). There was no significant difference in reported ease of use. Simply placing clinical information on an electronic system does not guarantee that the information will be easier to retrieve. Such information needs to be fully integrated into the clinical decision making process. Computerizing guidelines may provide a necessary initial step toward this goal, but it does not represent the final solution. PMID:10566503

The clinical development process for a novel preventive vaccine: An overview.

PubMed

Singh, K; Mehta, S

2016-01-01

Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.

[Clinical practice guidelines for assessment and treatment of transsexualism. SEEN Identity and Sexual Differentiation Group (GIDSEEN)].

PubMed

Moreno-Pérez, Oscar; Esteva De Antonio, Isabel

2012-01-01

Transsexual patients can only be diagnosed and treated at functional gender identity Units with provision of high quality care, development of clinical practice guidelines, and interdisciplinary working groups. The therapeutic process has three mainstays: initial psychological diagnostic evaluation and psychotherapy, endocrinological evaluation and hormone therapy, and sex reassignment surgery. Cross-sex hormone therapy is essential for the anatomical and psychological transition process in duly selected patients. Hormones help optimize real-life sex identity, improve quality of life, and limit psychiatric co-morbidities often associated to lack of treatment. Development of this clinical practice guideline addresses the need for implementing a coordinated action protocol for comprehensive health care for transgender people in the National Health System. Copyright © 2012 SEEN. Published by Elsevier Espana. All rights reserved.

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

Withdrawal of long-term epoprostenol therapy in pulmonary arterial hypertension (PAH).

PubMed

Calcaianu, George; Calcaianu, Mihaela; Canuet, Matthieu; Enache, Irina; Kessler, Romain

2017-01-01

Once initiated for pulmonary arterial hypertension (PAH), epoprostenol treatment usually needs to be delivered for an indefinite duration. It is possible that some participants could be transitioned from epoprostenol to oral therapies. We retrospectively evaluated eight PAH participants transitioned from epoprostenol to PAH oral drugs. The criteria for epoprostenol withdrawal were: (1) persistent improvement of clinic and hemodynamic status; (2) stable dose of epoprostenol for the last three months; and (3) the participant's preference for oral therapy after evaluation of risk-benefit. We evaluated the clinical, functional, and hemodynamic status at baseline, at withdrawal, and after the transition to oral PAH therapy. The transition was completed in all eight participants. Four participants had a complete successful transition (CT) with a stable clinical and hemodynamic course and four participants had a partial successful transition (PT) remaining stable clinically, with a mild hemodynamic worsening, but without need to re-initiate epoprostenol therapy. The four CT participants were treated with epoprostenol for a shorter period of time (CT group: 35 ± 30 versus PT group: 79 ± 49 months, P = 0.08). Mean epoprostenol dosage was lower in the CT group (CT group: 15 ± 1.5 ng/kg/min versus PT group: 24 ± 11 ng/kg/min, P = 0.09). Safe withdrawal of epoprostenol treatment and transition to oral PAH therapy was possible in a small and highly selected group of participants. The majority of these participants had a porto-pulmonary PAH or PAH associated to HIV infection.

Clinical characteristics of patients with tinnitus evaluated with the Tinnitus Sample Case History Questionnaire in Japan: A case series

PubMed Central

Kojima, Takashi; Kanzaki, Sho; Oishi, Naoki; Ogawa, Kaoru

2017-01-01

Background The Tinnitus Sample Case History Questionnaire was determined as a standardized questionnaire for obtaining patient case histories and for characterizing patients into subgroups at the Tinnitus Research Initiative in 2006. In this study, we developed a Japanese version of this questionnaire for evaluating the clinical characteristics of patients with tinnitus. The Japanese version of the questionnaire will be available for evaluating treatments for tinnitus and for comparing data on tinnitus in research centers. Aims/Objectives To evaluate the clinical characteristics of patients with tinnitus in Japan using a newly developed Japanese version of Tinnitus Sample Case History Questionnaire. Study design This was a prospective study based on patient records. Setting University hospitals, general hospitals, and clinics. Subjects and methods We collected patient data using a Japanese translated version of the Tinnitus Sample Case History Questionnaire. In total, 584 patients who visited our institutions in Japan between August 2012 and March 2014 were included (280 males and 304 females; age 13–92 years; mean age, 60.8). We examined patients after dividing them into two groups according to the presence or absence of hyperacusis. The collected results were compared with those from the Tinnitus Research Initiative database. Results Compared with the TRI database, there were significantly more elderly female patients and fewer patients with trauma-associated tinnitus. There was a statistically lower ratio of patients with hyperacusis. We found that patients with tinnitus in addition to hyperacusis had greater tinnitus severity and exhibited higher rates of various complications. Conclusion The Japanese version of the Tinnitus Sample Case History Questionnaire developed in this study can be a useful tool for evaluating patients with tinnitus in Japan. The results of this multicenter study reflect the characteristics of patients with tinnitus who require medical care in Japan. Our data provides a preliminary basis for an international comparison of tinnitus epidemiology. PMID:28841656

Clinical characteristics of patients with tinnitus evaluated with the Tinnitus Sample Case History Questionnaire in Japan: A case series.

PubMed

Kojima, Takashi; Kanzaki, Sho; Oishi, Naoki; Ogawa, Kaoru

2017-01-01

The Tinnitus Sample Case History Questionnaire was determined as a standardized questionnaire for obtaining patient case histories and for characterizing patients into subgroups at the Tinnitus Research Initiative in 2006. In this study, we developed a Japanese version of this questionnaire for evaluating the clinical characteristics of patients with tinnitus. The Japanese version of the questionnaire will be available for evaluating treatments for tinnitus and for comparing data on tinnitus in research centers. To evaluate the clinical characteristics of patients with tinnitus in Japan using a newly developed Japanese version of Tinnitus Sample Case History Questionnaire. This was a prospective study based on patient records. University hospitals, general hospitals, and clinics. We collected patient data using a Japanese translated version of the Tinnitus Sample Case History Questionnaire. In total, 584 patients who visited our institutions in Japan between August 2012 and March 2014 were included (280 males and 304 females; age 13-92 years; mean age, 60.8). We examined patients after dividing them into two groups according to the presence or absence of hyperacusis. The collected results were compared with those from the Tinnitus Research Initiative database. Compared with the TRI database, there were significantly more elderly female patients and fewer patients with trauma-associated tinnitus. There was a statistically lower ratio of patients with hyperacusis. We found that patients with tinnitus in addition to hyperacusis had greater tinnitus severity and exhibited higher rates of various complications. The Japanese version of the Tinnitus Sample Case History Questionnaire developed in this study can be a useful tool for evaluating patients with tinnitus in Japan. The results of this multicenter study reflect the characteristics of patients with tinnitus who require medical care in Japan. Our data provides a preliminary basis for an international comparison of tinnitus epidemiology.

A New Clinical Pain Knowledge Test for Nurses: Development and Psychometric Evaluation.

PubMed

Bernhofer, Esther I; St Marie, Barbara; Bena, James F

2017-08-01

All nurses care for patients with pain, and pain management knowledge and attitude surveys for nurses have been around since 1987. However, no validated knowledge test exists to measure postlicensure clinicians' knowledge of the core competencies of pain management in current complex patient populations. To develop and test the psychometric properties of an instrument designed to measure pain management knowledge of postlicensure nurses. Psychometric instrument validation. Four large Midwestern U.S. hospitals. Registered nurses employed full time and part time August 2015 to April 2016, aged M = 43.25 years; time as RN, M = 16.13 years. Prospective survey design using e-mail to invite nurses to take an electronic multiple choice pain knowledge test. Content validity of initial 36-item test "very good" (95.1% agreement). Completed tests that met analysis criteria, N = 747. Mean initial test score, 69.4% correct (range 27.8-97.2). After revision/removal of 13 unacceptable questions, mean test score was 50.4% correct (range 8.7-82.6). Initial test item percent difficulty range was 15.2%-98.1%; discrimination values range, 0.03-0.50; final test item percent difficulty range, 17.6%-91.1%, discrimination values range, -0.04 to 1.04. Split-half reliability final test was 0.66. A high decision consistency reliability was identified, with test cut-score of 75%. The final 23-item Clinical Pain Knowledge Test has acceptable discrimination, difficulty, decision consistency, reliability, and validity in the general clinical inpatient nurse population. This instrument will be useful in assessing pain management knowledge of clinical nurses to determine gaps in education, evaluate knowledge after pain management education, and measure research outcomes. Copyright © 2017 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

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

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.

The economics of treatment for infants with respiratory distress syndrome.

PubMed

Neil, N; Sullivan, S D; Lessler, D S

1998-01-01

To define clinical outcomes and prevailing patterns of care for the initial hospitalization of infants at greatest risk for respiratory distress syndrome (RDS); to estimate direct medical care costs associated with the initial hospitalization; and to introduce and demonstrate a simulation technique for the economic evaluation of health care technologies. Clinical outcomes and usual-care algorithms were determined for infants with RDS in three birthweight categories (500-1,000g; >1,000-1,500g; and >1,500g) using literature- and expert-panel-based data. The experts were practitioners from major U.S. hospitals who were directly involved in the clinical care of such infants. Using the framework derived from the usual care patterns and outcomes, the authors developed an itemized "micro-costing" economic model to simulate the costs associated with the initial hospitalization of a hypothetical RDS patient. The model is computerized and dynamic; unit costs, frequencies, number of days, probabilities and population multipliers are all variable and can be modified on the basis of new information or local conditions. Aggregated unit costs are used to estimate the expected medical costs of treatment per patient. Expected costs of initial hospitalization per uncomplicated surviving infant with RDS were estimated to be $101,867 for 500-1,000g infants; $64,524 for >1,000-1,500g infants; and $27,224 for >1,500g infants. Incremental costs of complications among survivors were estimated to be $22,155 (500-1,000g); $11,041 (>1,000-1,500g); and $2,448 (>1,500 g). Expected costs of initial hospitalization per case (including non-survivors) were $100,603; $72,353; and $28,756, respectively. An itemized model such as the one developed here serves as a benchmark for the economic assessment of treatment costs and utilization. Moreover, it offers a powerful tool for the prospective evaluation of new technologies or procedures designed to reduce the incidence of, severity of, and/or total hospital resource use ascribed to RDS.

Augmentin in acute exacerbations of chronic bronchitis.

PubMed

Aigner, K; Schindl, R; Mittermayer, H

1984-01-01

Forty-five patients with acute chronic bronchitis were treated with Augmentin, an amoxycillin combined with the beta-lactamase inhibitor clavulanic acid, initially by parenteral administration followed by oral treatment after 3 days lasting in the mean 7.1 days. The over-all clinical evaluation showed a cure rate of 93%. Side-effects were comparable to therapy with other amoxycillins. Bacteriological evaluation of the sputum samples demonstrated in 91% of cases an elimination of the initially isolated organism. Prior to therapy we found in 25% of the isolated strains beta-lactamase-producing and Augmentin-sensitive organisms. The parenteral formulation of Augmentin seems to be a valuable addition to the parenteral therapy of lower respiratory tract infections.

CAP--advancing the evaluation of preclinical Alzheimer disease treatments.

PubMed

Reiman, Eric M; Langbaum, Jessica B; Tariot, Pierre N; Lopera, Francisco; Bateman, Randall J; Morris, John C; Sperling, Reisa A; Aisen, Paul S; Roses, Allen D; Welsh-Bohmer, Kathleen A; Carrillo, Maria C; Weninger, Stacie

2016-01-01

If we are to find treatments to postpone, reduce the risk of, or completely prevent the clinical onset of Alzheimer disease (AD), we need faster methods to evaluate promising preclinical AD treatments, new ways to work together in support of common goals, and a determination to expedite the initiation and performance of preclinical AD trials. In this article, we note some of the current challenges, opportunities and emerging strategies in preclinical AD treatment. We describe the Collaboration for Alzheimer's Prevention (CAP)-a convening, harmonizing and consensus-building initiative to help stakeholders advance AD prevention research with rigour, care and maximal impact-and we demonstrate the impact of CAP on the goals and design of new preclinical AD trials.

A reference case for economic evaluations in osteoarthritis: an expert consensus article from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

PubMed

Hiligsmann, Mickaël; Cooper, Cyrus; Guillemin, Francis; Hochberg, Marc C; Tugwell, Peter; Arden, Nigel; Berenbaum, Francis; Boers, Maarten; Boonen, Annelies; Branco, Jaime C; Maria-Luisa, Brandi; Bruyère, Olivier; Gasparik, Andrea; Kanis, John A; Kvien, Tore K; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Pinedo-Villanueva, Rafael; Pinto, Daniel; Reiter-Niesert, Susanne; Rizzoli, René; Rovati, Lucio C; Severens, Johan L; Silverman, Stuart; Reginster, Jean-Yves

2014-12-01

General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in methodological approach. To develop a reference case specific for economic studies in OA, including the standard optimal care, with which to judge new pharmacologic and non-pharmacologic interventions. Four subgroups of an ESCEO expert working group on economic assessments (13 experts representing diverse aspects of clinical research and/or economic evaluations) were charged with producing lists of recommendations that would potentially improve the comparability of economic analyses in OA: outcome measures, comparators, costs and methodology. These proposals were discussed and refined during a face-to-face meeting in 2013. They are presented here in the format of the recommendations of the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, so that an initiative on economic analysis methodology might be consolidated with an initiative on reporting standards. Overall, three distinct reference cases are proposed, one for each hand, knee and hip OA; with diagnostic variations in the first two, giving rise to different treatment options: interphalangeal or thumb-based disease for hand OA and the presence or absence of joint malalignment for knee OA. A set of management strategies is proposed, which should be further evaluated to help establish a consensus on the "standard optimal care" in each proposed reference case. The recommendations on outcome measures, cost itemisation and methodological approaches are also provided. The ESCEO group proposes a set of disease-specific recommendations on the conduct and reporting of economic evaluations in OA that could help the standardisation and comparability of studies that evaluate therapeutic strategies of OA in terms of costs and effectiveness. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Validation of World Health Organisation HIV/AIDS clinical staging in predicting initiation of antiretroviral therapy and clinical predictors of low CD4 cell count in Uganda.

PubMed

Baveewo, Steven; Ssali, Francis; Karamagi, Charles; Kalyango, Joan N; Hahn, Judith A; Ekoru, Kenneth; Mugyenyi, Peter; Katabira, Elly

2011-05-12

The WHO clinical guidelines for HIV/AIDS are widely used in resource limited settings to represent the gold standard of CD4 counts for antiviral therapy initiation. The utility of the WHO-defined stage 1 and 2 clinical factors used in WHO HIV/AIDS clinical staging in predicting low CD4 cell count has not been established in Uganda. Although the WHO staging has shown low sensitivity for predicting CD4<200 cells/mm(3), it has not been evaluated at for CD4 cut-offs of <250 cells/mm(3) or <350 cells/mm(3). To validate the World Health Organisation HIV/AIDS clinical staging in predicting initiation of antiretroviral therapy in a low-resource setting and to determine the clinical predictors of low CD4 cell count in Uganda. Data was collected on 395 participants from the Joint Clinical Research Centre, of whom 242 (61.3%) were classified as in stages 1 and 2 and 262 (68%) were females. Participants had a mean age of 36.8 years (SD 8.5). We found a significant inverse correlation between the CD4 lymphocyte count and WHO clinical stages. The sensitivity the WHO clinical staging at CD4 cell count of 250 cells/mm(3) and 350 cells/mm(3) was 53.5% and 49.1% respectively. Angular cheilitis, papular pruritic eruptions and recurrent upper respiratory tract infections were found to be significant predictors of low CD4 cell count among participants in WHO stage 1 and 2. The WHO HIV/AIDS clinical staging guidelines have a low sensitivity and about half of the participants in stages 1 and 2 would be eligible for ART initiation if they had been tested for CD4 count. Angular cheilitis and papular pruritic eruptions and recurrent upper respiratory tract infections may be used, in addition to the WHO staging, to improve sensitivity in the interim, as access to CD4 machines increases in Uganda.

Developing an evaluation framework for clinical redesign programs: lessons learnt.

PubMed

Samaranayake, Premaratne; Dadich, Ann; Fitzgerald, Anneke; Zeitz, Kathryn

2016-09-19

Purpose The purpose of this paper is to present lessons learnt through the development of an evaluation framework for a clinical redesign programme - the aim of which was to improve the patient journey through improved discharge practices within an Australian public hospital. Design/methodology/approach The development of the evaluation framework involved three stages - namely, the analysis of secondary data relating to the discharge planning pathway; the analysis of primary data including field-notes and interview transcripts on hospital processes; and the triangulation of these data sets to devise the framework. The evaluation framework ensured that resource use, process management, patient satisfaction, and staff well-being and productivity were each connected with measures, targets, and the aim of clinical redesign programme. Findings The application of business process management and a balanced scorecard enabled a different way of framing the evaluation, ensuring measurable outcomes were connected to inputs and outputs. Lessons learnt include: first, the importance of mixed-methods research to devise the framework and evaluate the redesigned processes; second, the need for appropriate tools and resources to adequately capture change across the different domains of the redesign programme; and third, the value of developing and applying an evaluative framework progressively. Research limitations/implications The evaluation framework is limited by its retrospective application to a clinical process redesign programme. Originality/value This research supports benchmarking with national and international practices in relation to best practice healthcare redesign processes. Additionally, it provides a theoretical contribution on evaluating health services improvement and redesign initiatives.

A US database study characterizing patients initiating a budesonide-formoterol combination versus tiotropium bromide as initial maintenance therapy for chronic obstructive pulmonary disease.

PubMed

Kern, David M; Williams, Setareh A; Tunceli, Ozgur; Wessman, Catrin; Zhou, Siting; Pethick, Ned; Elhefni, Hanaa; Trudo, Frank

2014-01-01

To compare clinical and demographic characteristics, resource utilization and costs of chronic obstructive pulmonary disease (COPD) patients prior to initiating budesonide-formoterol combination (BFC) or tiotropium-maintenance therapy. This cross-sectional study used claims-based diagnosis to identify COPD patients in the HealthCore Integrated Research Database who initiated BFC or tiotropium therapy between March 1, 2009 and January 31, 2012 (intake period); the index date was defined as the initial prescription fill for either agent. Patients diagnosed with respiratory tract cancer or receiving inhaled corticosteroids/long-acting β2-adrenergic agonists or tiotropium in 12 months prior to index date were excluded. Categorical variables were evaluated with χ(2) tests; mean cost differences were evaluated using γ-regression. Overall, 6,940 BFC and 10,831 tiotropium patients were identified. The BFC group was younger (mean age 64 versus 67 years), with a greater proportion of females (54% versus 51%). BFC-treated patients had more comorbid respiratory conditions, including asthma (25% versus 13%), but fewer comorbid cardiovascular conditions, including atherosclerosis (7% versus 10%) and myocardial infarction (4% versus 6%). A greater proportion of BFC patients received prior respiratory medication, including oral corticosteroids (46% versus 35%) and short-acting β2-agonists (44% versus 35%). Tiotropium-treated patients had a greater mean number of COPD-related outpatient visits (4.6 versus 4.1). BFC-treated patients had lower total all-cause ($17,259 versus $17,926) and COPD-related ($1,718 versus $1,930) health care costs, driven by lower all-cause and COPD-related inpatient expenditures. Initiators of BFC or tiotropium showed differences in clinical and demographic characteristics and health care utilization and costs prior to starting COPD maintenance therapy.

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.

Retrievable inferior vena cava filters can be placed and removed with a high degree of success: Initial experience.

PubMed

Cohoon, Kevin P; McBride, Joseph; Friese, Jeremy L; McPhail, Ian R

2015-10-01

Evaluate the success rate of retrievable inferior vena cava filter (IVC) removal in a tertiary care practice. Retrievable IVC filters became readily available in the United States following Food and Drug Administration approval in 2003, and their use has increased dramatically. They represent an attractive option for patients with contraindications to anticoagulation who may only need short-term protection against pulmonary embolism. All patients who had undergone placement of a retrievable IVC filter at Mayo Clinic between 2003 and 2005 were retrospectively reviewed to evaluate our initial experience with retrievable inferior vena cava filters at a large tertiary care center. During a three-year-period of time, Mayo Clinic, Rochester, MN placed 892 IVC filters of which 460 were retrievable. Of the 460 retrievable filters placed (249 Günther Tulip®, 207 Recovery®, and 4 OptEase®), retrieval was attempted in 223 (48.5%). Of 223 initial attempts, 196 (87.9%) were initially successful and 27 (12.1%) were unsuccessful. Of the 27 unsuccessful initial retrieval attempts, 23 (85.2%) were because of the presence of significant thrombus within the filter and 4 (14.8%) were because of tilting and strut perforation. Of the 23 filters containing significant thrombus, 9 (39.1%) were later retrieved after a period of anticoagulation and resolution of the thrombus. Retrievable IVC filters can be removed with a high degree of success. Approximately one in ten retrievable IVC filter removal attempts may fail initially, usually because of significant thrombus within the filter. This does not preclude possible removal at a later date. © 2015 Wiley Periodicals, Inc.

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.

Instituting parent education practices in the neonatal intensive care unit: an administrative case report of practice evaluation and statewide action.

PubMed

Dusing, Stacey C; Van Drew, Catherine M; Brown, Shaaron E

2012-07-01

Infants born preterm are at high risk of developmental disabilities and benefit from early developmental intervention programs. Physical therapists with neonatal expertise are ideally suited to educate parents about ways to support their infant's development in the first months of life. However, administrative policies are needed to support the therapist in providing adequate parent education in the neonatal intensive care unit (NICU). This administrative case report describes the process used by a team of neonatal therapists to evaluate clinical practice, determine the need for change, and develop and implement a new parent education program in the NICU. Physical therapy parent education practices were evaluated in an academic medical center with a 36-bed, level-3 NICU. Physical therapists with neonatal expertise covered multiple units within the hospital each day. A series of focus groups, a small descriptive study, and staff discussion were used to evaluate parent education practices in this academic medical center. A new parent education program was developed based on data collected and literature to improve clinical care. The new parent education model was implemented over the course of several months using overlapping initiatives. Administrative support for the change was developed through collaboration, open communication, and presentation of clinical data. In addition, this hospital-based program contributed to the development of a statewide initiative to educate parents of preterm infants about the importance of supporting development in the first months of life. A collaborative and data-driven approach to evaluating parent education practices supported the development of a new parent education practice while acknowledging the need to meet staff productivity standards and provide excellent care throughout the hospital.

Instituting Parent Education Practices in the Neonatal Intensive Care Unit: An Administrative Case Report of Practice Evaluation and Statewide Action

PubMed Central

Van Drew, Catherine M.; Brown, Shaaron E.

2012-01-01

Background and Purpose Infants born preterm are at high risk of developmental disabilities and benefit from early developmental intervention programs. Physical therapists with neonatal expertise are ideally suited to educate parents about ways to support their infant's development in the first months of life. However, administrative policies are needed to support the therapist in providing adequate parent education in the neonatal intensive care unit (NICU). This administrative case report describes the process used by a team of neonatal therapists to evaluate clinical practice, determine the need for change, and develop and implement a new parent education program in the NICU. Case Description Physical therapy parent education practices were evaluated in an academic medical center with a 36-bed, level-3 NICU. Physical therapists with neonatal expertise covered multiple units within the hospital each day. A series of focus groups, a small descriptive study, and staff discussion were used to evaluate parent education practices in this academic medical center. A new parent education program was developed based on data collected and literature to improve clinical care. Outcomes The new parent education model was implemented over the course of several months using overlapping initiatives. Administrative support for the change was developed through collaboration, open communication, and presentation of clinical data. In addition, this hospital-based program contributed to the development of a statewide initiative to educate parents of preterm infants about the importance of supporting development in the first months of life. Discussion A collaborative and data-driven approach to evaluating parent education practices supported the development of a new parent education practice while acknowledging the need to meet staff productivity standards and provide excellent care throughout the hospital. PMID:22466024

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.

Clinical evaluation of a new pressure ulcer risk assessment instrument, the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE T).

PubMed

Coleman, Susanne; Smith, Isabelle L; McGinnis, Elizabeth; Keen, Justin; Muir, Delia; Wilson, Lyn; Stubbs, Nikki; Dealey, Carol; Brown, Sarah; Nelson, E Andrea; Nixon, Jane

2018-02-01

To test the psychometric properties and clinical usability of a new Pressure Ulcer Risk Assessment Instrument including inter-rater and test-retest reliability, convergent validity and data completeness. Methodological and practical limitations associated with traditional Pressure Ulcer Risk Assessment Instruments, prompted a programme to work to develop a new instrument, as part of the National Institute for Health Research funded, Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056). Observational field test. For this clinical evaluation 230 patients were purposefully sampled across four broad levels of pressure ulcer risk with representation from four secondary care and four community NHS Trusts in England. Blinded and simultaneous paired (ward/community nurse and expert nurse) PURPOSE-T assessments were undertaken. Follow-up retest was undertaken by the expert nurse. Field notes of PURPOSE-T use were collected. Data were collected October 2012-January 2013. The clinical evaluation demonstrated "very good" (kappa) inter-rater and test-retest agreement for PURPOSE-T assessment decision overall. The percentage agreement for "problem/no problem" was over 75% for the main risk factors. Convergent validity demonstrated moderate to high associations with other measures of similar constructs. The PURPOSE-T evaluation facilitated the initial validation and clinical usability of the instrument and demonstrated that PURPOSE-T is suitable of use in clinical practice. Further study is needed to evaluate the impact of using the instrument on care processes and outcomes. © 2017 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

Assessing biocomputational modelling in transforming clinical guidelines for osteoporosis management.

PubMed

Thiel, Rainer; Viceconti, Marco; Stroetmann, Karl

2011-01-01

Biocomputational modelling as developed by the European Virtual Physiological Human (VPH) Initiative is the area of ICT most likely to revolutionise in the longer term the practice of medicine. Using the example of osteoporosis management, a socio-economic assessment framework is presented that captures how the transformation of clinical guidelines through VPH models can be evaluated. Applied to the Osteoporotic Virtual Physiological Human Project, a consequent benefit-cost analysis delivers promising results, both methodologically and substantially.

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

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.

Updates on ultrasound research in implant dentistry: a systematic review of potential clinical indications.

PubMed

Bhaskar, Vaishnavi; Chan, Hsun-Liang; MacEachern, Mark; Kripfgans, Oliver D

2018-05-23

Ultrasonography has shown promising diagnostic value in dental implant imaging research; however, exactly how ultrasound was used and at what stage of implant therapy it can be applied has not been systematically evaluated. Therefore, the aim of this review is to investigate potential indications of ultrasound use in the three implant treatment phases, namely planning, intraoperative and postoperative phase. Eligible manuscripts were searched in major databases with a combination of key words related to the use of ultrasound imaging in implant therapy. An initial search yielded 414 articles, after further review, 28 articles were finally included for this systematic review. Ultrasound was found valuable, though at various development stages, for evaluating (1) soft tissues, (2) hard tissues (3) vital structures and (4) implant stability. B-mode, the main function to image anatomical structures of interest, has been evaluated in pre-clinical and clinical studies. Quantitative ultrasound parameters, e.g. sound speed and amplitude, are being developed to evaluate implant-bone stability, mainly in simulation and pre-clinical studies. Ultrasound could be potentially useful in all 3 treatment phases. In the planning phase, ultrasound could evaluate vital structures, tissue biotype, ridge width/density, and cortical bone thickness. During surgery, it can provide feedback by identifying vital structures and bone boundary. At follow-up visits, it could evaluate marginal bone level and implant stability. Understanding the current status of ultrasound imaging research for implant therapy would be extremely beneficial for accelerating translational research and its use in dental clinics.

Clinical manifestations, response to treatment, and clinical outcome for Weimaraners with hypertrophic osteodystrophy: 53 cases (2009–2011)

PubMed Central

Safra, Noa; Johnson, Eric G.; Lit, Lisa; Foreman, Oded; Wolf, Zena T.; Aguilar, Miriam; Karmi, Nili; Finno, Carrie J.; Bannasch, Danika L.

2014-01-01

Objective To evaluate clinical manifestations, response to treatment, and outcome for Weimaraners with hypertrophic osteodystrophy (HOD). Design Retrospective case series. Animals 53 dogs. Procedures Medical records were reviewed for signalment, vaccination history, clinical signs, laboratory test results, response to treatment, and relapses. Radiographs were reviewed. Results Clinical signs included pyrexia, lethargy, and ostealgia; signs involving the gastrointestinal, ocular, or cutaneous systems were detected. Of the 53 dogs, 28 (52.8%) had HOD-affected littermates. Dogs with HOD-affected littermates were more likely to relapse, compared with the likelihood of relapse for dogs with no HOD-affected littermates. All 53 dogs had been vaccinated 1 to 30 days before HOD onset; no difference was found between the number of dogs with a history of vaccination with a recombinant vaccine (n = 21) versus a nonrecombinant vaccine (32). Fifty (94.3%) dogs had radiographic lesions compatible with HOD at disease onset, and the other 3 (5.7%) had HOD lesions 48 to 72 hours after the onset of clinical signs. Twelve of 22 (54.5%) dogs treated with NSAIDs did not achieve remission by 7 days after initiation of treatment. All dogs treated initially with corticosteroids achieved remission within 8 to 48 hours. Of the 33 dogs that reached adulthood, 28 (84.8%) were healthy and 5 (15.2%) had episodes of pyrexia and malaise. Conclusions and Clinical Relevance Treatment with corticosteroids was superior to treatment with NSAIDs in Weimaraners with HOD. It may be necessary to evaluate repeated radiographs to establish a diagnosis of HOD. Most HOD-affected Weimaraners had resolution of the condition with physeal closure. PMID:23600784

Management of children exposed to Mycobacterium tuberculosis: a public health evaluation in West Java, Indonesia

PubMed Central

Ruslami, Rovina; Anselmo, Melissa; Alisjahbana, Bachti; Yulianti, Neti; Sampurno, Hedy; van Crevel, Reinout; Hill, Philip C

2013-01-01

Abstract Objective To investigate qualitatively and quantitatively the performance of a programme for managing the child contacts of adult tuberculosis patients in Indonesia. Methods A public health evaluation framework was used to assess gaps in a child contact management programme at a lung clinic. Targets for programme performance indicators were derived from established programme indicator targets, the scientific literature and expert opinion. Compliance with tuberculosis screening, the initiation of isoniazid preventive therapy in children younger than 5 years, the accuracy of tuberculosis diagnosis and adherence to preventive therapy were assessed in 755 child contacts in two cohorts. In addition, 22 primary caregivers and 34 clinic staff were interviewed to evaluate knowledge and acceptance of child contact management. The cost to caregivers was recorded. Gaps between observed and target indicator values were quantified. Findings The gaps between observed and target performance indicators were: 82% for screening compliance; 64 to 100% for diagnostic accuracy, 50% for the initiation of preventive therapy, 54% for adherence to therapy and 50% for costs. Many staff did not have adequate knowledge of, or an appropriate attitude towards, child contact management, especially regarding isoniazid preventive therapy. Caregivers had good knowledge of screening but not of preventive therapy and had difficulty travelling to the clinic and paying costs. Conclusion The study identified widespread gaps in the performance of a child contact management system in Indonesia, all of which appear amenable to intervention. The public health evaluation framework used could be applied in other settings where child contact management is failing. PMID:24347732

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.

Vaginal and Sexual Health Treatment Strategies within a Female Sexual Medicine Program for Cancer Patients and Survivors

PubMed Central

Carter, Jeanne; Stabile, Cara; Seidel, Barbara; Baser, Raymond E.; Goldfarb, Shari; Goldfrank, Deborah J.

2016-01-01

Purpose We sought to evaluate patient adherence and response to simple vaginal and sexual health treatment strategies in female cancer patients receiving treatment at a female sexual medicine and health program, and identify improvements of physical symptoms, per patient and clinical evaluation. Methods Evalubility criteria included gynecologic exam at initial visit; at least one follow-up with gynecologic exam within 8 months of initial visit; and all consecutive follow-ups <6 months apart. Demographics, medical information, and clinical assessments from 175 evaluable patients with at least 1 follow-up from 09/12–10/14 were analyzed. The majority of patients were being treated for or had a history of breast (n=90, 53%), gynecologic (n=54, 32%), or colorectal/anal (n=15, 9%) cancers. An assessment form included a clinician evaluation, Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), and patient-reported outcomes. Compliance with treatment recommendations were summarized, and changes over time were compared for clinical outcomes. Results Mean number of visits was 3.43. Mean age was 55.4 years; 92% (n=155/169) were in menopause. Treatment strategies included rationale and instruction for use of vaginal moisturizers, lubricants, pelvic floor exercises and dilator therapy, in addition to psychosexual education regarding sexual changes (response, anatomy and function) associated with cancer treatment and support. At last assessment, 89% had complied with the clinical recommendation (moisturize 2–5+ times/week). Vaginal pH scores >6.5 declined over time (p=0.03). VAS scores improved by last assessment (p<0.001), as did VuAS scores (p=0.001). Sexual function scores significantly improved (p<0.001), confidence about future sexual activity increased (p=0.004), and sexual/vaginal health concerns decreased (p=0.00003). Conclusion Significant changes were observed in women using treatment strategies, with improvement in vulvovaginal symptoms, a decrease in elevated vaginal pH and pain with exams, enhanced sexual function, and intimacy confidence. Implications for Cancer Survivors These findings have high clinical relevance for symptom management with improvement of sexual function using simple strategies and clinical tools in the oncology setting. PMID:27868156

Mid-Level Healthcare Personnel Training: An Evaluation of the Revised, Nationally-Standardized, Pre-Service Curriculum for Clinical Officers in Mozambique

PubMed Central

Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Augusto, Gerito; Cesar, Freide; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

2014-01-01

Introduction Mozambique suffers from a critical shortage of healthcare workers. Mid-level healthcare workers, (Tecnicos de Medicina Geral (TMG)), in Mozambique require less money and time to train than physicians. From 2009–2010, the Mozambique Ministry of Health (MoH) and the International Training and Education Center for Health (I-TECH), University of Washington, Seattle, revised the TMG curriculum. To evaluate the effect of the curriculum revision, we used mixed methods to determine: 1) if TMGs meet the MoH's basic standards of clinical competency; and 2) do scores on measurements of clinical knowledge, physical exam, and clinical case scenarios differ by curriculum? Methods T-tests of differences in means examined differences in continuous score variables between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related and demographic factors associated with assessment scores on each of the three evaluation methods at the p<0.05 level. Qualitative interviews and focus groups inform interpretation. Results We found no significant differences in sex, marital status and age between the 112 and 189 TMGs in initial and revised curriculum, respectively. Mean scores at graduation of initial curriculum TMGs were 56.7%, 63.5%, and 49.1% on the clinical cases, knowledge test, and physical exam, respectively. Scores did not differ significantly from TMGs in the revised curriculum. Results from linear regression models find that training institute was the most significant predictor of TMG scores on both the clinical cases and physical exam. Conclusion TMGs trained in either curriculum may be inadequately prepared to provide quality care. Curriculum changes are a necessary, but insufficient, part of improving TMG knowledge and skills overall. A more comprehensive, multi-level approach to improving TMG training that includes post-graduation mentoring, strengthening the pre-service internship training, and greater resources for training institute faculty may result in improvements in TMG capacity and patient care over time. PMID:25068590

Mid-level healthcare personnel training: an evaluation of the revised, nationally-standardized, pre-service curriculum for clinical officers in Mozambique.

PubMed

Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Augusto, Gerito; Cesar, Freide; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

2014-01-01

Mozambique suffers from a critical shortage of healthcare workers. Mid-level healthcare workers, (Tecnicos de Medicina Geral (TMG)), in Mozambique require less money and time to train than physicians. From 2009-2010, the Mozambique Ministry of Health (MoH) and the International Training and Education Center for Health (I-TECH), University of Washington, Seattle, revised the TMG curriculum. To evaluate the effect of the curriculum revision, we used mixed methods to determine: 1) if TMGs meet the MoH's basic standards of clinical competency; and 2) do scores on measurements of clinical knowledge, physical exam, and clinical case scenarios differ by curriculum? T-tests of differences in means examined differences in continuous score variables between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related and demographic factors associated with assessment scores on each of the three evaluation methods at the p<0.05 level. Qualitative interviews and focus groups inform interpretation. We found no significant differences in sex, marital status and age between the 112 and 189 TMGs in initial and revised curriculum, respectively. Mean scores at graduation of initial curriculum TMGs were 56.7%, 63.5%, and 49.1% on the clinical cases, knowledge test, and physical exam, respectively. Scores did not differ significantly from TMGs in the revised curriculum. Results from linear regression models find that training institute was the most significant predictor of TMG scores on both the clinical cases and physical exam. TMGs trained in either curriculum may be inadequately prepared to provide quality care. Curriculum changes are a necessary, but insufficient, part of improving TMG knowledge and skills overall. A more comprehensive, multi-level approach to improving TMG training that includes post-graduation mentoring, strengthening the pre-service internship training, and greater resources for training institute faculty may result in improvements in TMG capacity and patient care over time.

Exploring the measurement properties of the osteopathy clinical teaching questionnaire using Rasch analysis.

PubMed

Vaughan, Brett

2018-01-01

Clinical teaching evaluations are common in health profession education programs to ensure students are receiving a quality clinical education experience. Questionnaires students use to evaluate their clinical teachers have been developed in professions such as medicine and nursing. The development of a questionnaire that is specifically for the osteopathy on-campus, student-led clinic environment is warranted. Previous work developed the 30-item Osteopathy Clinical Teaching Questionnaire. The current study utilised Rasch analysis to investigate the construct validity of the Osteopathy Clinical Teaching Questionnaire and provide evidence for the validity argument through fit to the Rasch model. Senior osteopathy students at four institutions in Australia, New Zealand and the United Kingdom rated their clinical teachers using the Osteopathy Clinical Teaching Questionnaire. Three hundred and ninety-nine valid responses were received and the data were evaluated for fit to the Rasch model. Reliability estimations (Cronbach's alpha and McDonald's omega) were also evaluated for the final model. The initial analysis demonstrated the data did not fit the Rasch model. Accordingly, modifications to the questionnaire were made including removing items, removing person responses, and rescoring one item. The final model contained 12 items and fit to the Rasch model was adequate. Support for unidimensionality was demonstrated through both the Principal Components Analysis/t-test, and the Cronbach's alpha and McDonald's omega reliability estimates. Analysis of the questionnaire using McDonald's omega hierarchical supported a general factor (quality of clinical teaching in osteopathy). The evidence for unidimensionality and the presence of a general factor support the calculation of a total score for the questionnaire as a sufficient statistic. Further work is now required to investigate the reliability of the 12-item Osteopathy Clinical Teaching Questionnaire to provide evidence for the validity argument.

Recruiting phobic research subjects: effectiveness and cost.

PubMed

Kaakko, T; Murtomaa, H; Milgrom, P; Getz, T; Ramsay, D S; Coldwell, S E

2001-01-01

Efficiently enrolling subjects is one of the most important and difficult aspects of a clinical trial. This prospective study evaluated strategies used in the recruitment of 144 dental injection phobics for a clinical trial evaluating the effectiveness of combining alprazolam with exposure therapy. Three types of recruitment strategies were evaluated: paid advertising, free publicity, and professional referral. Sixty-three percent of subjects were enrolled using paid advertising (the majority of them from bus advertisements [27.0%], posters on the University of Washington campus [20.1%], and newspaper advertisements [13.2%]). Free publicity (eg, television coverage, word of mouth) yielded 18.8% of enrolled subjects and professionaL referrals 14.6% of subjects. The average cost (1996 dollars) of enrolling 1 subject was $79. Bus and poster advertising attracted more initial contacts and yielded the greatest enrollment.

A practical model for economic evaluation of tissue-engineered therapies.

PubMed

Tan, Tien-En; Peh, Gary S L; Finkelstein, Eric A; Mehta, Jodhbir S

2015-01-01

Tissue-engineered therapies are being developed across virtually all fields of medicine. Some of these therapies are already in clinical use, while others are still in clinical trials or the experimental phase. Most initial studies in the evaluation of new therapies focus on demonstration of clinical efficacy. However, cost considerations or economic viability are just as important. Many tissue-engineered therapies have failed to be impactful because of shortcomings in economic competitiveness, rather than clinical efficacy. Furthermore, such economic viability studies should be performed early in the process of development, before significant investment has been made. Cost-minimization analysis combined with sensitivity analysis is a useful model for the economic evaluation of new tissue-engineered therapies. The analysis can be performed early in the development process, and can provide valuable information to guide further investment and research. The utility of the model is illustrated with the practical real-world example of tissue-engineered constructs for corneal endothelial transplantation. The authors have declared no conflicts of interest for this article. © 2015 Wiley Periodicals, Inc.

The Quantitative Evaluation of the Clinical and Translational Science Awards (CTSA) Program Based on Science Mapping and Scientometric Analysis

PubMed Central

Zhang, Yin; Wang, Lei

2013-01-01

Abstract The Clinical and Translational Science Awards (CTSA) program is one of the most important initiatives in translational medical funding. The quantitative evaluation of the efficiency and performance of the CTSA program has a significant referential meaning for the decision making of global translational medical funding. Using science mapping and scientometric analytic tools, this study quantitatively analyzed the scientific articles funded by the CTSA program. The results of the study showed that the quantitative productivities of the CTSA program had a stable increase since 2008. In addition, the emerging trends of the research funded by the CTSA program covered clinical and basic medical research fields. The academic benefits from the CTSA program were assisting its members to build a robust academic home for the Clinical and Translational Science and to attract other financial support. This study provided a quantitative evaluation of the CTSA program based on science mapping and scientometric analysis. Further research is required to compare and optimize other quantitative methods and to integrate various research results. PMID:24330689

The quantitative evaluation of the Clinical and Translational Science Awards (CTSA) program based on science mapping and scientometric analysis.

PubMed

Zhang, Yin; Wang, Lei; Diao, Tianxi

2013-12-01

The Clinical and Translational Science Awards (CTSA) program is one of the most important initiatives in translational medical funding. The quantitative evaluation of the efficiency and performance of the CTSA program has a significant referential meaning for the decision making of global translational medical funding. Using science mapping and scientometric analytic tools, this study quantitatively analyzed the scientific articles funded by the CTSA program. The results of the study showed that the quantitative productivities of the CTSA program had a stable increase since 2008. In addition, the emerging trends of the research funded by the CTSA program covered clinical and basic medical research fields. The academic benefits from the CTSA program were assisting its members to build a robust academic home for the Clinical and Translational Science and to attract other financial support. This study provided a quantitative evaluation of the CTSA program based on science mapping and scientometric analysis. Further research is required to compare and optimize other quantitative methods and to integrate various research results. © 2013 Wiley Periodicals, Inc.

Assessing Caregiver Information Needs: A Brief Questionnaire.

ERIC Educational Resources Information Center

Simonton, Linda J.; Haugland, S. M.

A diagnostic evaluation for a person with suspected Alzheimer's disease is usually initiated by family members whose concerns go beyond strictly medical issues. To determine precisely what questions families want answered, a 15-point questionnaire was developed at a multi-disciplinary geriatric assessment clinic. Caregivers were asked to rate each…

45 CFR 51.4 - How will the plans be evaluated?

Code of Federal Regulations, 2013 CFR

2013-10-01

... manpower shortage areas, as established under section 332 of the Public Health Service Act, and for... units which will provide broader clinical experiences, or (5) Initiating research projects. (d) The... schools who are citizens of the United States, as demonstrated, for example, by: (1) Broad-based...

45 CFR 51.4 - How will the plans be evaluated?

Code of Federal Regulations, 2011 CFR

2011-10-01

... manpower shortage areas, as established under section 332 of the Public Health Service Act, and for... units which will provide broader clinical experiences, or (5) Initiating research projects. (d) The... schools who are citizens of the United States, as demonstrated, for example, by: (1) Broad-based...

45 CFR 51.4 - How will the plans be evaluated?

Code of Federal Regulations, 2010 CFR

2010-10-01

... manpower shortage areas, as established under section 332 of the Public Health Service Act, and for... units which will provide broader clinical experiences, or (5) Initiating research projects. (d) The... schools who are citizens of the United States, as demonstrated, for example, by: (1) Broad-based...

45 CFR 51.4 - How will the plans be evaluated?

Code of Federal Regulations, 2014 CFR

2014-10-01

... manpower shortage areas, as established under section 332 of the Public Health Service Act, and for... units which will provide broader clinical experiences, or (5) Initiating research projects. (d) The... schools who are citizens of the United States, as demonstrated, for example, by: (1) Broad-based...

45 CFR 51.4 - How will the plans be evaluated?

Code of Federal Regulations, 2012 CFR

2012-10-01

... manpower shortage areas, as established under section 332 of the Public Health Service Act, and for... units which will provide broader clinical experiences, or (5) Initiating research projects. (d) The... schools who are citizens of the United States, as demonstrated, for example, by: (1) Broad-based...

The effect of a "universal antiretroviral therapy" recommendation on HIV RNA levels among HIV-infected patients entering care with a CD4 count greater than 500/μL in a public health setting.

PubMed

Geng, Elvin H; Hare, C Bradley; Kahn, James O; Jain, Vivek; Van Nunnery, Tracy; Christopoulos, Katerina A; Deeks, Steven G; Gandhi, Monica; Havlir, Diane V

2012-12-01

On 1 January 2010, a large, publicly funded clinic in San Francisco announced a "universal ART" approach to initiate antiretroviral therapy (ART) in all human immunodeficiency virus (HIV)-infected persons. The effect of changing guidance on real-world patient outcomes has not been evaluated. We evaluated untreated adult patients (defined as going >90 days without ART use) visiting clinic from 2001 to 2011. The cumulative incidence of HIV RNA suppression (viral load, <500 copies/mL), stratified by CD4 cell count at entry and calendar dates representing guideline issuance, were estimated using a competing risk framework. A multivariate Poisson-based model identified factors associated with HIV RNA suppression 6 months after clinic entry. Of 2245 adults, 87% were male, and the median age was 39 years (interquartile range, 33-45 years). In 534 patients entering clinic with a CD4 cell count of >500 cells/µL, the 1-year incidence of HIV RNA suppression was 10.1% (95% confidence interval [CI], 6.6%-14.6%) before 4 April 2005; 9.1% (95% CI, 3.6%-17.4%) from 4 April 2005 to 1 December 2007; 14.1% (95% CI, 7.5%-22.8%) from 1 December 2007 to the universal ART recommendation and 52.8% (95% CI, 38.2%-65.4%) after. After adjustment, the SFGH policy was associated with a 6-fold increase in the probability of HIV RNA suppression 6 months after clinic entry. Recommendations to initiate ART in all HIV-infected patients increased the rate of HIV RNA suppression for patients enrolling in care with a CD4 cell count of >500 cells/µL and may foreshadow national trends given the March 2012 revision of national treatment guidelines to favor ART initiation for persons with CD4 cell counts of >500 cells/µL.

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.

Using the Frailty Assessment for Care Planning Tool (FACT) to screen elderly chronic kidney disease patients for frailty: the nurse experience.

PubMed

Moffatt, Heather; Moorhouse, Paige; Mallery, Laurie; Landry, David; Tennankore, Karthik

2018-01-01

Recent evidence supports the prognostic significance of frailty for functional decline and poor health outcomes in patients with chronic kidney disease. Yet, despite the development of clinical tools to screen for frailty, little is known about the experiential impact of screening for frailty in this setting. The Frailty Assessment for Care Planning Tool (FACT) evaluates frailty across 4 domains: mobility, function, social circumstances, and cognition. The purpose of this qualitative study was as follows: 1) explore the nurse experience of screening for frailty using the FACT tool in a specialized outpatient renal clinic; 2) determine how, if at all, provider perceptions of frailty changed after implementation of the frailty screening tool; and 3) determine the perceived factors that influence uptake and administration of the FACT screening tool in a specialized clinical setting. A semi-structured interview of 5 nurses from the Nova Scotia Health Authority, Central Zone Renal Clinic was conducted. A grounded theory approach was used to generate thematic categories and analysis models. Four primary themes emerged in the data analysis: "we were skeptical", "we made it work", "we learned how", and "we understand". As the renal nurses gained a sense of confidence in their ability to implement the FACT tool, initial barriers to implementation were attenuated. Implementation factors - such as realistic goals, clear guidelines, and ongoing training - were important factors for successful uptake of the frailty screening initiative. Nurse participants reported an overall positive experience using the FACT method to screen for frailty and indicated that their understanding of the multiple dimensions and subtleties of "frailty" were enhanced. Future nurse-led FACT screening initiatives should incorporate those factors identified as being integral to program success: realistic goals, clear guidelines, and ongoing training. Adopting the evaluation of frailty as a priority within clinical departments will encourage sustainability.

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.

Clinical, Virologic, Immunologic Outcomes and Emerging HIV Drug Resistance Patterns in Children and Adolescents in Public ART Care in Zimbabwe

PubMed Central

Makadzange, A. T.; Higgins-Biddle, M.; Chimukangara, B.; Birri, R.; Gordon, M.; Mahlanza, T.; McHugh, G.; van Dijk, J. H.; Bwakura-Dangarembizi, M.; Ndung’u, T.; Masimirembwa, C.; Phelps, B.; Amzel, A.; Ojikutu, B. O.; Walker, B. D.; Ndhlovu, C. E.

2015-01-01

Objective To determine immunologic, virologic outcomes and drug resistance among children and adolescents receiving care during routine programmatic implementation in a low-income country. Methods A cross-sectional evaluation with collection of clinical and laboratory data for children (0-<10 years) and adolescents (10–19 years) attending a public ART program in Harare providing care for pediatric patients since 2004, was conducted. Longitudinal data for each participant was obtained from the clinic based medical record. Results Data from 599 children and adolescents was evaluated. The participants presented to care with low CD4 cell count and CD4%, median baseline CD4% was lower in adolescents compared with children (11.0% vs. 15.0%, p<0.0001). The median age at ART initiation was 8.0 years (IQR 3.0, 12.0); median time on ART was 2.9 years (IQR 1.7, 4.5). On ART, median CD4% improved for all age groups but remained below 25%. Older age (≥ 5 years) at ART initiation was associated with severe stunting (HAZ <-2: 53.3% vs. 28.4%, p<0.0001). Virologic failure rate was 30.6% and associated with age at ART initiation. In children, nevirapine based ART regimen was associated with a 3-fold increased risk of failure (AOR: 3.5; 95% CI: 1.3, 9.1, p = 0.0180). Children (<10y) on ART for ≥4 years had higher failure rates than those on ART for <4 years (39.6% vs. 23.9%, p = 0.0239). In those initiating ART as adolescents, each additional year in age above 10 years at the time of ART initiation (AOR 0.4 95%CI: 0.1, 0.9, p = 0.0324), and each additional year on ART (AOR 0.4, 95%CI 0.2, 0.9, p = 0.0379) were associated with decreased risk of virologic failure. Drug resistance was evident in 67.6% of sequenced virus isolates. Conclusions During routine programmatic implementation of HIV care for children and adolescents, delayed age at ART initiation has long-term implications on immunologic recovery, growth and virologic outcomes. PMID:26658814

The Dissociative Subtype of PTSD Scale (DSPS): Initial Evaluation in a National Sample of Trauma-Exposed Veterans

PubMed Central

Wolf, Erika J.; Mitchell, Karen S.; Sadeh, Naomi; Hein, Christina; Fuhrman, Isaac; Pietrzak, Robert H.; Miller, Mark W.

2015-01-01

The fifth edition of the Diagnostic and Statistical Manual (DSM-5) includes a dissociative subtype of posttraumatic stress disorder (PTSD), but no existing measures specifically assess it. This paper describes the initial evaluation of a 15-item self-report measure of the subtype called the Dissociative Subtype of PTSD Scale (DSPS) in an on-line survey of 697 trauma-exposed military veterans representative of the US veteran population. Exploratory factor analyses of the lifetime DSPS items supported the intended structure of the measure consisting of three factors reflecting derealization/depersonalization, loss of awareness, and psychogenic amnesia. Consistent with prior research, latent profile analyses assigned 8.3% of the sample to a highly dissociative class distinguished by pronounced symptoms of derealization and depersonalization. Overall, results provide initial psychometric support for the lifetime DSPS scales; additional research in clinical and community samples is needed to further validate the measure. PMID:26603115

The Dissociative Subtype of PTSD Scale: Initial Evaluation in a National Sample of Trauma-Exposed Veterans.

PubMed

Wolf, Erika J; Mitchell, Karen S; Sadeh, Naomi; Hein, Christina; Fuhrman, Isaac; Pietrzak, Robert H; Miller, Mark W

2017-06-01

The fifth edition of the Diagnostic and Statistical Manual includes a dissociative subtype of posttraumatic stress disorder, but no existing measures specifically assess it. This article describes the initial evaluation of a 15-item self-report measure of the subtype called the Dissociative Subtype of Posttraumatic Stress Disorder Scale (DSPS) in an online survey of 697 trauma-exposed military veterans representative of the U.S. veteran population. Exploratory factor analyses of the lifetime DSPS items supported the intended structure of the measure consisting of three factors reflecting derealization/depersonalization, loss of awareness, and psychogenic amnesia. Consistent with prior research, latent profile analyses assigned 8.3% of the sample to a highly dissociative class distinguished by pronounced symptoms of derealization and depersonalization. Overall, results provide initial psychometric support for the lifetime DSPS scales; additional research in clinical and community samples is needed to further validate the measure.

Effect of eccentric exercise program for early tibialis posterior tendinopathy.

PubMed

Kulig, Kornelia; Lederhaus, Eric S; Reischl, Steve; Arya, Shruti; Bashford, Greg

2009-09-01

Morphology and vascularization of painful tibialis posterior (TP) tendons before and after an intervention targeting the degenerated tendon were examined. Functional status and pain level were also assessed. A10-week twice daily, progressive eccentric tendon loading, calf stretching program with orthoses was implemented with ten, early stage TP tendinopathy subjects. TP tendons were imaged by grayscale and Doppler ultrasound at INITIAL and POST evaluations to assess the tendon's morphology and signs of neovascularization. The Foot Functional Index (FFI), Physical Activity Scale (PAS), 5-Minute Walk Test, and single heel raise (SHR) test were completed at INITIAL and POST evaluations. The Global Rating Scale (GRS) was completed at 6 months followup. One-way ANOVA was used to compare the FFI at INITIAL, POST, and 6-MONTH time points. Paired t-tests were used to compare means between the remaining variables. The level of significance was p = 0.05. There was a significant difference in FFI total, pain, and disability at the three time-points. Post-hoc paired t-tests revealed that the FFI scores were lower for the total score and pain and disability subcategories when comparing from INITIAL to POST and INITIAL to 6-MONTH evaluations (p < 0.05 for all). The number of SHR increased significantly on the involved side from INITIAL to POST evaluation (p = 0.041). The GRS demonstrated minimum clinically important differences for improvements in symptoms at 6-MONTH. Tendon morphology and vascularization remained abnormal following the intervention. A 10-week tendon specific eccentric program resulted in improvements in symptoms and function without changes in tendon morphology or neovascularization.

Use of the initial trauma CT scan to aid in diagnosis of open pelvic fractures.

PubMed

Scolaro, John A; Wilson, David J; Routt, Milton Lee Chip; Firoozabadi, Reza

2015-10-01

Open pelvic disruptions represent high-energy injuries. The prompt identification and management of these injuries decreases their associated morbidity and mortality. Computed tomography (CT) scans are routinely obtained in the initial evaluation of patients with pelvic injuries. The purpose of this study is to identify the incidence and source of air densities noted on computed tomography (CT) scans of the abdominal and pelvic region in patients with pelvic fractures and evaluate the use of initial CT imaging as an adjunctive diagnostic tool to identify open injuries. A retrospective review of a prospectively collected database was performed at a single institution. Seven hundred and twenty-two consecutive patients with a pelvic disruption over a two-year period were included. Review of initial injury CT scans was performed using bone and lung viewing algorithms to identify the presence of extra-luminal air. The primary outcome was the presence, location and source of air identified on pre-operative CT scans. Secondary measurements were identification of air by plain radiograph and correlation between identified air densities on CT and clinically diagnosed open pelvic fractures. Ninety-eight patients were identified as having extra-luminal air densities on CT scans. Eighty-one patients were included in the final analysis following application of inclusion and exclusion criteria. Air was noted by the radiologist in forty-five (55.6%) instances. Six patients (7.4%) were clinically diagnosed with an open pelvic ring disruption; in two patients (2.4%) this diagnosis was delayed. In all patients, the CT was able to track air from its origin. In patients with pelvic disruptions, the injury CT should also be evaluated for the presence and source of extra-luminal air. In some patients, this finding may represent an open pelvic ring disruption. A complete physical exam and CT evaluation should be used to decrease the missed or delayed diagnosis of an open pelvic ring injury. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Research-IQ: Development and Evaluation of an Ontology-anchored Integrative Query Tool

PubMed Central

Borlawsky, Tara B.; Lele, Omkar; Payne, Philip R. O.

2011-01-01

Investigators in the translational research and systems medicine domains require highly usable, efficient and integrative tools and methods that allow for the navigation of and reasoning over emerging large-scale data sets. Such resources must cover a spectrum of granularity from bio-molecules to population phenotypes. Given such information needs, we report upon the initial design and evaluation of an ontology-anchored integrative query tool, Research-IQ, which employs a combination of conceptual knowledge engineering and information retrieval techniques to enable the intuitive and rapid construction of queries, in terms of semi-structured textual propositions, that can subsequently be applied to integrative data sets. Our initial results, based upon both quantitative and qualitative evaluations of the efficacy and usability of Research-IQ, demonstrate its potential to increase clinical and translational research throughput. PMID:21821150

Evolution of an information literacy curriculum for third-year medical students.

PubMed

O'Dwyer, Linda; Kerns, Stephanie C

2011-01-01

Information literacy curriculum for third-year medical students at Northwestern University has evolved over several years under the guidance of librarians at the Galter Health Sciences Library. Starting as a series of rotation-specific information resource overviews, initial evaluation and feedback led to the curriculum being developed to include more focused and interactive clinical information sessions with a quiz-based assessment. Future enhancements will include web-based self-directed learning using online tutorials, additional search exercises that mimic the on-the-go clinical environment, and better assessment of the curriculum's impact on students' information literacy and clinical search skills.

Bioterrorism: a Laboratory Who Does It?

PubMed Central

Lee, Philip A.; Rowlinson, Marie-Claire

2014-01-01

In October 2001, the first disseminated biological warfare attack was perpetrated on American soil. Initially, a few clinical microbiology laboratories were testing specimens from acutely ill patients and also being asked to test nasal swabs from the potentially exposed. Soon after, a significant number of clinical microbiology and public health laboratories received similar requests to test the worried well or evaluate potentially contaminated mail or environmental materials, sometimes from their own break rooms. The role of the clinical and public health microbiology laboratory in response to a select agent event or act of bioterrorism is reviewed. PMID:24648550

Vaginal and sexual health treatment strategies within a female sexual medicine program for cancer patients and survivors.

PubMed

Carter, Jeanne; Stabile, Cara; Seidel, Barbara; Baser, Raymond E; Goldfarb, Shari; Goldfrank, Deborah J

2017-04-01

We sought to evaluate patient adherence and response to simple vaginal and sexual health treatment strategies in female cancer patients receiving treatment at a female sexual medicine and health program and identify improvements of physical symptoms, per patient and clinical evaluation. Evaluability criteria included gynecologic exam at initial visit, at least one follow-up with gynecologic exam within 8 months of initial visit, and all consecutive follow-ups <6 months apart. Demographics, medical information, and clinical assessments from 175 evaluable patients with at least one follow-up from 09/12 to 10/14 were analyzed. The majority of patients were being treated for or had a history of breast (n = 90, 53 %), gynecologic (n = 54, 32 %), or colorectal/anal (n = 15, 9 %) cancers. An assessment form included a clinician evaluation, Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), and patient-reported outcomes. Compliance with treatment recommendations were summarized, and changes over time were compared for clinical outcomes. Mean number of visits was 3.43. Mean age was 55.4 years; 92 % (n = 155/169) were in menopause. Treatment strategies included rationale and instruction for use of vaginal moisturizers, lubricants, pelvic floor exercises, and dilator therapy, in addition to psychosexual education regarding sexual changes (response, anatomy, and function) associated with cancer treatment and support. At last assessment, 89 % had complied with the clinical recommendation (moisturize 2-5+ times/week). Vaginal pH scores >6.5 declined over time (p = 0.03). VAS scores improved by last assessment (p < 0.001), as did VuAS scores (p = 0.001). Sexual function scores significantly improved (p < 0.001), confidence about future sexual activity increased (p = 0.004), and sexual/vaginal health concerns decreased (p = 0.00003). Significant changes were observed in women using treatment strategies, with improvement in vulvovaginal symptoms, a decrease in elevated vaginal pH and pain with exams, enhanced sexual function, and increased intimacy confidence. These findings have high clinical relevance for symptom management with improvement of sexual function using simple strategies and clinical tools in the oncology setting.

[A French tool for evaluation of home palliative care: adaptation of the Support Team Assessment Schedule].

PubMed

Lagabrielle, D; Guyot, F; Jasso, G; Couturier, P; Poussin, G; Frossard, M; Szabo, P; Franco, A

2001-09-01

The authors describe the utilisation of a quality assessment tool for palliative care administered at home. The questionnaire entitled Support Team Assessment Schedule (STAS) was translated from English for this study. It was then utilised comparatively with different quality of life evaluation instruments. Only the results of the STAS are described here. The approach allows for the unresolved problems in the care to come to the surface week after week. The STAS comprises nine items pertaining to the patient and his/her family, and seven items concerning the services provided. The study exhibits the results of 107 evaluations completed from 50 patients stricken with cancer or AIDS in an advanced phase. The availability of this auto clinical audit tool, employable at home or in a hospital, constitutes an essential initial step in the field of French-speaking clinical evaluation of palliative care.

Efficacy of the early administration of valacyclovir hydrochloride for the treatment of neuropathogenic equine herpesvirus type-1 infection in horses.

PubMed

Maxwell, Lara K; Bentz, Bradford G; Gilliam, Lyndi L; Ritchey, Jerry W; Pusterla, Nicola; Eberle, R; Holbrook, Todd C; McFarlane, Dianne; Rezabek, Grant B; Meinkoth, James; Whitfield, Chase; Goad, Carla L; Allen, George P

2017-10-01

OBJECTIVE To determine whether prophylactic administration of valacyclovir hydrochloride versus initiation of treatment at the onset of fever would differentially protect horses from viral replication and clinical disease attributable to equine herpesvirus type-1 (EHV-1) infection. ANIMALS 18 aged mares. PROCEDURES Horses were randomly assigned to receive an oral placebo (control), treatment at detection of fever, or prophylactic treatment (initiated 1 day prior to viral challenge) and then inoculated intranasally with a neuropathogenic strain of EHV-1. Placebo or valacyclovir was administered orally for 7 or 14 days after EHV-1 inoculation or detection of fever (3 horses/group). Effects of treatment on viral replication and clinical disease were evaluated. Plasma acyclovir concentrations and viremia were assessed to determine inhibitory concentrations of valacyclovir. RESULTS Valacyclovir administration decreased shedding of virus and viremia, compared with findings for control horses. Rectal temperatures and clinical disease scores in horses that received valacyclovir prophylactically for 2 weeks were lower than those in control horses. The severity of but not the risk for ataxia was decreased by valacyclovir administration. Viremia was decreased when steady-state trough plasma acyclovir concentrations were > 0.8 μg/mL, supporting the time-dependent activity of acyclovir. CONCLUSIONS AND CLINICAL RELEVANCE Valacyclovir treatment significantly decreased viral replication and signs of disease in EHV-1-infected horses; effects were greatest when treatment was initiated before viral inoculation, but treatment was also effective when initiated as late as 2 days after inoculation. During an outbreak of equine herpesvirus myeloencephalopathy, antiviral treatment may be initiated in horses at various stages of infection, including horses that have not yet developed signs of viral disease.

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.

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.

Can clinical CT data improve forensic reconstruction?

PubMed

Schuh, P; Scheurer, E; Fritz, K; Pavlic, M; Hassler, E; Rienmüller, R; Yen, K

2013-05-01

In accidents resulting in severe injuries, a clinical forensic examination is generally abandoned in the initial phase due to high-priority clinical needs. However, in many cases, data from clinical computed tomography (CT) examinations are available. The goals of this prospective study were (a) to evaluate clinical CT data as a basis for forensic reconstruction of the sequence of events, (b) to assess if forensic radiological follow-up reading improves the forensic diagnostic benefit compared to the written clinical radiological reports, and (c) to evaluate if full data storage including additional reconstructed 0.6-mm slices enhances forensic analysis. Clinical CT data of 15 living individuals with imaging of at least the head, thorax, and abdomen following polytrauma were examined regarding the forensic evaluation of the sequence of events. Additionally, 0.6-mm slices and 3D images were reconstructed for forensic purposes and used for the evaluation. At the forensic radiological readings, additional traumatic findings were observed in ten of the 15 patients. The main weakness of the clinical reports was that they were not detailed enough, particularly regarding the localization of injuries and description of wound morphology. In seven cases, however, forensic conclusions were possible on the basis of the written clinical reports, whereas in five cases forensic reconstruction required specific follow-up reading. The additional 0.6-mm slices were easily available and with improved 3D image quality and forensic diagnostics. In conclusion, the use of clinical CT data can considerably support forensic expertise regarding reconstruction issues. Forensic follow-up reading as well as the use of additional thin slices for 3D analysis can further improve its benefit for forensic reconstruction purposes.

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.

Students take the lead for learning in practice: A process for building self-efficacy into undergraduate nursing education.

PubMed

Henderson, Amanda; Harrison, Penny; Rowe, Jennifer; Edwards, Sam; Barnes, Margaret; Henderson, Simon; Henderson, Amanda

2018-04-10

To prepare graduate nurses for practice, the curriculum and pedagogy need to facilitate student engagement, active learning and the development of self-efficacy. This pilot project describes and explores an initiative, the Check-in and Check-out process, that aims to engage students as active partners in their learning and teaching in their clinical preparation for practice. Three interdependent elements make up the process: a check-in (briefing) part; a clinical practice part, which supports students as they engage in their learning and practise clinical skills; and a check-out (debriefing) part. A student evaluation of this initiative confirmed the value of the process, which has subsequently been embedded in the preparation for practice and work-integrated learning courses in the undergraduate nursing programs at the participating university. The introduction of a singular learning process provides consistency in the learning approach used across clinical learning spaces, irrespective of their location or focus. A consistent learning process-including a common language that easily transfers across all clinical courses and clinical settings-arguably enhances the students' learning experience, helps them to actively manage their preparation for clinical practice and to develop self-efficacy. Copyright © 2018. Published by Elsevier Ltd.

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

Multiple sclerosis masquerading as Alzheimer-type dementia: Clinical, radiological and pathological findings.

PubMed

Tobin, W O; Popescu, B F; Lowe, V; Pirko, I; Parisi, J E; Kantarci, K; Fields, J A; Bruns, M B; Boeve, B F; Lucchinetti, C F

2016-04-01

We report a comprehensive clinical, radiological, neuropsychometric and pathological evaluation of a woman with a clinical diagnosis of AD dementia (ADem), but whose autopsy demonstrated widespread demyelination, without Alzheimer disease (AD) pathology. Initial neuropsychometric evaluation suggested amnestic mild cognitive impairment (aMCI). Serial magnetic resonance images (MRI) images demonstrated the rate of increase in her ventricular volume was comparable to that of 46 subjects with aMCI who progressed to ADem, without accumulating white matter disease. Myelin immunohistochemistry at autopsy demonstrated extensive cortical subpial demyelination. Subpial lesions involved the upper cortical layers, and often extended through the entire width of the cortex. Multiple sclerosis (MS) can cause severe cortical dysfunction and mimic ADem. Cortical demyelination is not well detected by standard imaging modalities and may not be detected on autopsy without myelin immunohistochemistry. © The Author(s), 2015.

Upper extremity paraesthesia: clinical assessment and reasoning.

PubMed

Muscolino, Joseph E

2008-07-01

The art of clinical assessment involves an accurate determination of the cause(s) of a patient's symptoms. Given that a set of symptoms can be influenced by many contributing factors and features, assessment needs to differentially evaluate these. Accurate and appropriate treatment depends on differential assessment based on sound clinical reasoning. Many conditions derive from multiple causes demanding evaluation of as many etiological features as can be identified. The case review presented here involves a patient presenting with paraesthesia spreading into her right upper extremity. A complex history, involving her neck and contralateral upper extremity was assessed. The patient was found to have at least seven underlying, predisposing, and etiological, conditions capable of initiating, aggravating, or maintaining the presenting symptoms. Weighing the relative contributions of these often interacting features, and correlating this with the history, helped to identify a successful course of treatment.

Results from an audit feedback strategy for chronic obstructive pulmonary disease in-hospital care: a joint analysis from the AUDIPOC and European COPD audit studies.

PubMed

Lopez-Campos, Jose Luis; Asensio-Cruz, M Isabel; Castro-Acosta, Ady; Calero, Carmen; Pozo-Rodriguez, Francisco

2014-01-01

Clinical audits have emerged as a potential tool to summarize the clinical performance of healthcare over a specified period of time. However, the effectiveness of audit and feedback has shown inconsistent results and the impact of audit and feedback on clinical performance has not been evaluated for COPD exacerbations. In the present study, we analyzed the results of two consecutive nationwide clinical audits performed in Spain to evaluate both the in-hospital clinical care provided and the feedback strategy. The present study is an analysis of two clinical audits performed in Spain that evaluated the clinical care provided to COPD patients who were admitted to the hospital for a COPD exacerbation. The first audit was performed from November-December 2008. The feedback strategy consisted of personalized reports for each participant center, the presentation and discussion of the results at regional, national and international meetings and the creation of health-care quality standards for COPD. The second audit was part of a European study during January and February 2011. The impact of the feedback strategy was evaluated in term of clinical care provided and in-hospital survival. A total of 94 centers participated in the two audits, recruiting 8,143 admissions (audit 1∶3,493 and audit 2∶4,650). The initially provided clinical care was reasonably acceptable even though there was considerable variability. Several diagnostic and therapeutic procedures improved in the second audit. Although the differences were significant, the degree of improvement was small to moderate. We found no impact on in-hospital mortality. The present study describes COPD hospital care in Spanish hospitals and evaluates the impact of peer-benchmarked, individually written and group-oral feedback strategy on the clinical outcomes for treating COPD exacerbations. It describes small to moderate improvements in the clinical care provided to COPD patients with no impact on in-hospital mortality.

Evidence-based training and mentorship combined with enhanced outcomes surveillance to address the leading causes of neonatal mortality at the district hospital level in Ghana.

PubMed

Brantuo, Mary N A; Cristofalo, Elizabeth; Meheš, Mira M; Ameh, Juliana; Brako, Nana Okai; Boahene, Frederick; Adjei, Stella B; Opoku, Ernest; Banda, Harriet; Wang, Yu T; Forgor, Abdulai A; Punguire, Damien; Brightson, Kennedy; Sottie, Cynthia; Owusu-Agyei, Seth; Williams, John E; Sulemana, Abubakari; Oduro, Abraham R; Gyampong, Margaret; Sarpong, Doris; Andrews, Edith; Gyansa-Lutterodt, Martha; Hodgson, Abraham; Bannerman, Cynthia; Abdullah, Fizan

2014-04-01

To evaluate the impact of a district hospital intervention focused on enhancing healthcare provider capacity to address leading causes of neonatal death: birth asphyxia, infection and prematurity. The neonatal quality improvement initiative was launched at two intervention referral district hospitals in Ghana. Local Health and Demographic Surveillance Systems were enlisted to enhance recording of neonatal and infant deaths in the community and at the facility. After baseline site assessments, a team of local paediatric experts conducted three clinical trainings on-site at each intervention hospital. Assessments were conducted to evaluate participant knowledge before and after participation in training modules. Monthly mentorship visits provided additional training to support the adoption of essential early neonatal care practices. In the first year of implementation, the initiative provided focused clinical training to 278 participants. A comparison of pre- and post-training test results demonstrates significant improvement in provider knowledge (73% vs. 89% correct, P < 0.001), with even greater improvement among trainees receiving recurrent refresher training (86% vs. 94% correct, P < 0.001). Participant feedback following training revealed enthusiasm about the programme and improved confidence. Locally led initiatives that invest directly in healthcare provider education and health systems strengthening represent a promising avenue for reducing neonatal morbidity and mortality. The NQI initiative demonstrates the positive impact of a district hospital intervention that combines on-site training, mentorship and enhanced demographic surveillance. © 2014 John Wiley & Sons Ltd.

Clinical evaluation of a two-incision fistula technique for the treatment of oral ranulas.

PubMed

Wang, Shaoyi; Zhang, Zhiyuan; Yang, Chi

2016-01-01

Oral ranulas are caused by extravasation of mucus from the sublingual glands, and the preferred treatment varies. We have developed a two-incision fistula operation for their treatment, and in this clinical study we have evaluated the efficacy and safety of this approach. Twelve patients with oral ranulas confirmed by fine needle aspiration cytology were enrolled and gave their consent to be treated by our new technique. The clinical outcomes and complications were evaluated during a period that ranged from 8-24 months. Nine ranulas became smaller and gradually disappeared, and there were no complications or injury to Wharton's duct. Three ranulas recurred, but disappeared after a second operation. The two-incision fistula operation can be effective and safe as an initial treatment for oral ranulas, and the method may become the preferred management for retention cysts. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Evaluation of a Statewide HIV-HCV-STD Online Clinical Education Program by Healthcare Providers - A Comparison of Nursing and Other Disciplines.

PubMed

Wang, Dongwen; Luque, Amneris E

2016-01-01

The New York State HIV-HCV-STD Clinical Education Initiative (CEI) has developed a large repository of online resources and disseminated them to a wide range of healthcare providers. To evaluate the CEI online education program and in particular to compare the self-reported measures by clinicians from different disciplines, we analyzed the data from 1,558 course completions in a study period of three months. The results have shown that the overall evaluations by the clinicians were very positive. Meanwhile, there were significant differences across the clinical disciplines. In particular, physicians and nurse practitioners were the most satisfied. In contrast, pharmacists and case/care managers recorded lower than average responses. Nurses and counselors had mixed results. Nurse practitioners' responses were very similar to physicians on most measures, but significantly different from nurses in many aspects. For more effective knowledge dissemination, online education programs should consider the unique needs by clinicians from specific disciplines.

The impact of health insurance mandates on drug innovation: evidence from the United States.

PubMed

Chun, Natalie; Park, Minjung

2013-04-01

An important health policy issue is the low rate of patient enrollment into clinical trials, which may slow down the process of clinical trials and discourage their supply, leading to delays in innovative life-saving drug treatments reaching the general population. In the US, patients' cost of participating in a clinical trial is considered to be a major barrier to patient enrollment. In order to reduce this barrier, some states in the US have implemented policies requiring health insurers to cover routine care costs for patients enrolled in clinical trials. This paper evaluates empirically how effective these policies were in increasing the supply of clinical trials and speeding up their completion, using data on cancer clinical trials initiated in the US between 2001 and 2007. Our analysis indicates that the policies did not lead to an increased supply in the number of clinical trials conducted in mandate states compared to non-mandate states. However, we find some evidence that once clinical trials are initiated, they are more likely to finish their patient recruitment in a timely manner in mandate states than in non-mandate states. As a result, the overall length to completion was significantly shorter in mandate states than in non-mandate states for cancer clinical trials in certain phases. The findings hint at the possibility that these policies might encourage drug innovation in the long run.

The Role of Formative Evaluation in Implementation Research and the QUERI Experience

PubMed Central

Stetler, Cheryl B; Legro, Marcia W; Wallace, Carolyn M; Bowman, Candice; Guihan, Marylou; Hagedorn, Hildi; Kimmel, Barbara; Sharp, Nancy D; Smith, Jeffrey L

2006-01-01

This article describes the importance and role of 4 stages of formative evaluation in our growing understanding of how to implement research findings into practice in order to improve the quality of clinical care. It reviews limitations of traditional approaches to implementation research and presents a rationale for new thinking and use of new methods. Developmental, implementation-focused, progress-focused, and interpretive evaluations are then defined and illustrated with examples from Veterans Health Administration Quality Enhancement Research Initiative projects. This article also provides methodologic details and highlights challenges encountered in actualizing formative evaluation within implementation research. PMID:16637954

Rapid detection of methicillin resistance in coagulase-negative staphylococci by a penicillin-binding protein 2a-specific latex agglutination test.

PubMed

Horstkotte, M A; Knobloch, J K; Rohde, H; Mack, D

2001-10-01

The detection of PBP 2a by the MRSA-Screen latex agglutination test with 201 clinical coagulase-negative staphylococci had an initial sensitivity of 98% and a high degree of specificity for Staphylococcus epidermidis strains compared to PCR for mecA. Determination of oxacillin MICs evaluated according to the new breakpoint (0.5 microg/ml) of the National Committee for Clinical Laboratory Standards exhibited an extremely low specificity for this population.

76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

...The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.

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

Evaluation of outcome and prognostic factors for dogs living greater than one year after diagnosis of osteosarcoma: 90 cases (1997–2008)

PubMed Central

Culp, William T. N.; Olea-Popelka, Francisco; Sefton, Jennifer; Aldridge, Charles F.; Withrow, Stephen J.; Lafferty, Mary H.; Rebhun, Robert B.; Kent, Michael S.; Ehrhart, Nicole

2015-01-01

Objective To evaluate clinical characteristics, outcome, and prognostic variables in a cohort of dogs surviving > 1 year after an initial diagnosis of osteosarcoma. Design Retrospective case series. Animals 90 client-owned dogs. Procedures Medical records for an 11-year period from 1997 through 2008 were reviewed, and patients with appendicular osteosarcoma that lived > 1 year after initial histopathologic diagnosis were studied. Variables including signalment, weight, serum alkaline phosphatase activity, tumor location, surgery, and adjuvant therapies were recorded. Median survival times were calculated by means of a Kaplan-Meier survival function. Univariate analysis was conducted to compare the survival function for categorical variables, and the Cox proportional hazard model was used to evaluate the likelihood of death > 1 year after diagnosis on the basis of the selected risk factors. Results 90 dogs met the inclusion criteria; clinical laboratory information was not available in all cases. Median age was 8.2 years (range, 2.7 to 13.3 years), and median weight was 38 kg (83.6 lb; range, 21 to 80 kg [46.2 to 176 lb]). Serum alkaline phosphatase activity was high in 29 of 60 (48%) dogs. The most common tumor location was the distal portion of the radius (54/90 [60%]). Eighty-nine of 90 (99%) dogs underwent surgery, and 78 (87%) received chemotherapy. Overall, 49 of 90 (54%) dogs developed metastatic disease. The median survival time beyond 1 year was 243 days (range, 1 to 1,899 days). Dogs that developed a surgical-site infection after limb-sparing surgery had a significantly improved prognosis > 1 year after osteosarcoma diagnosis, compared with dogs that did not develop infections. Conclusions and Clinical Relevance Results of the present study indicated that dogs with an initial diagnosis of osteosarcoma that lived > 1 year had a median survival time beyond the initial year of approximately 8 months. As reported previously, the development of a surgical-site infection in dogs undergoing a limb-sparing surgery significantly affected prognosis and warrants further study. PMID:25356715

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

The Cost-Effective Evaluation of Syncope.

PubMed

Angus, Steven

2016-09-01

Syncope is a common clinical problem that carries a high socioeconomic burden. A structured approach in the evaluation of syncope with special emphasis on a detailed history, comprehensive physical examination that includes orthostatic vital signs, and an electrocardiogram, proves to be the most cost-effective approach. The need for additional testing and hospital admission should be based on the results of the initial evaluation and use of risk-stratification tools that help identify those syncope patients at highest risk for poor outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Bone scintigraphy in hypervitaminosis A

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

Miller, J.H.; Hayon, I.I.

1985-04-01

The diagnosis of vitamin A intoxification may be difficult at the time of initial presentation. The radionuclide bone scan in cases of vitamin A toxicity may serve as a more sensitive indicator of the presence of this disease than radiographs in the initial evaluation and follow-up of patients with skeletal involvement. This is achieved at a lower radiation dose to the patient. The authors present a case in which bone scintigraphy played a crucial role in the early identification of this disorder. The radionuclide examination was the first method that indicated the presence of this disorder, significantly before changes demonstrablemore » on conventional radiography. The clinical and scintigraphic appearance of this process should be recognized to allow identification of hypervitaminosis A before the clinical symptoms become severe or permanent skeletal deformities result.« less

Novel challenges of multi-society investigator-initiated studies: a paradigm shift for technique and technology evaluation.

PubMed

Schwaitzberg, Steven D; Hawes, Robert H; Rattner, David W; Kochman, Michael L

2013-08-01

The introduction of innovative techniques and novel technologies into clinical practice is a challenge that confronts all aspects of healthcare delivery. Upheaval from shrinking research funding and declining healthcare reimbursements now forces patients, doctors, hospitals, payers, regulators, and even health systems into conflict as new therapies struggle to find a place in the therapeutic armamentarium. The escalating costs of healthcare force all parties to consider both the medical risks/benefits as well as the economic efficiency of proposed tools and therapies. We highlight these challenges by examining the process of initiating and conducting a "society-as-investigator" clinical trial to assess the safety of the natural orifice translumenal endoscopic surgery (NOTES) approach to cholecystectomy in the context of the issues that confront technology diffusion today.

The clinical outcome of childhood masturbation.

PubMed

Unal, F

2000-01-01

This study was performed to investigate the clinical outcome of childhood masturbation. For this purpose 50 children (mean age = 48.7 +/- 24.5 months, 34 girls females and 16 boys males) with masturbation symptoms were examined at first visit to the Department of Child Psychiatry and two years thereafter with psychiatric interviews. The mean masturbation frequency at the initial interview was significantly decreased after two years. It was noted that 39 children (78%) were completely recovered and 11 children (22%) continued to masturbate after two years. Children who did not recover were significantly younger, began to masturbate earlier and masturbated more frequently than others at the time of initial evaluation. It was concluded that the findings about the beneficial effect of sedative drugs in combination with parental guidance, education and means for behavior modification were promising.

Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

PubMed

Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

2017-01-03

The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

CT should replace three-view radiographs as the initial screening test in patients at high, moderate, and low risk for blunt cervical spine injury: a prospective comparison.

PubMed

Bailitz, John; Starr, Frederic; Beecroft, Matthew; Bankoff, Jon; Roberts, Roxanne; Bokhari, Faran; Joseph, Kimberly; Wiley, Dorian; Dennis, Andrew; Gilkey, Susan; Erickson, Paul; Raksin, Patricia; Nagy, Kimberly

2009-06-01

An estimated 10,000 Americans suffer cervical spine injuries each year. More than 800,000 cervical spine radiographs (CSR) are ordered annually. The human and healthcare costs associated with these injuries are enormous especially when diagnosis is delayed. Controversy exists in the literature concerning the diagnostic accuracy of CSR, with reported sensitivity ranging from 32% to 89%. We sought to compare prospectively the sensitivity of cervical CT (CCT) to CSR in the initial diagnosis of blunt cervical spine injury for patients meeting one or more of the NEXUS criteria. The study prospectively compared the diagnostic accuracy of CSR to CCT in consecutive patients evaluated for blunt trauma during 23 months at an urban, public teaching hospital and Level I Trauma Center. Inclusion criteria were adult patient, evaluated for blunt cervical spine injury, meeting one or more of the NEXUS criteria. All patients received both three-view CSR and CCT as part of a standard diagnostic protocol. Each CSR and CCT study was interpreted independently by a different radiology attending who was blinded to the results of the other study. Clinically significant injuries were defined as those requiring one or more of the following interventions: operative procedure, halo application, and/or rigid cervical collar. Of 1,583 consecutive patients evaluated for blunt cervical spine trauma, 78 (4.9%) patients received only CCT or CSR and were excluded from the study. Of the remaining 1,505 patients, 78 (4.9%) had evidence of a radiographic injury by CSR or CCT. Of these 78 patients with radiographic injury, 50 (3.3%) patients had clinically significant injuries. CCT detected all patients with clinically significant injuries (100% sensitive), whereas CSR detected only 18 (36% sensitive). Of the 50 patients, 15 were at high risk, 19 at moderate risk, and 16 at low risk for cervical spine injury according to previously published risk stratification. CSR detected clinically significant injury in 7 high risk (46% sensitive), 7 moderate risk (37% sensitive), and 4 low risk patients (25% sensitive). Our results demonstrate the superiority of CCT compared with CSR for the detection of clinically significant cervical spine injury. The improved ability to exclude injury rapidly provides further evidence that CCT should replace CSR for the initial evaluation of blunt cervical spine injury in patients at any risk for injury.

Pressure ulcer risk assessment and prevention: what difference does a risk scale make? A comparison between Norway and Ireland.

PubMed

Johansen, E; Moore, Z; van Etten, M; Strapp, H

2014-07-01

To explore similarities and differences in nurses' views on risk assessment practices and preventive care activities in a context where patients' risk of developing pressure ulcers is assessed using clinical judgment (Norway) and a context where patients' risk of developing pressure ulcers is assessed using a formal structured risk assessment combined with clinical judgement (Ireland). A descriptive, qualitative design was employed across two different care settings with a total of 14 health care workers, nine from Norway and five from Ireland. Regardless of whether risk assessment was undertaken using clinical judgment or formal structured risk assessment, identified risk factors, at risk patients and appropriate preventive initiatives discussed by participant were similar across care settings. Furthermore, risk assessment did not necessarily result in the planning and implementation of appropriate pressure ulcer prevention initiatives. Thus, in this instance, use of a formal risk assessment tool does not seem to make any difference to the planning, initiation and evaluation of pressure ulcer prevention strategies. Regardless of the method of risk assessment, patients at risk of developing pressure ulcers are detected, suggesting that the practice of risk assessment should be re-evaluated. Moreover, appropriate preventive interventions were described. However, the missing link between risk assessment and documented care planning is of concern and barriers to appropriate pressure ulcer documentation should be explored further. This work is partly funded by a research grant from the Norwegian Nurses Organisation (NNO) (Norsk Sykepleierforbund NSF) in 2012. The authors have no conflict of interest to declare.

CAP—advancing the evaluation of preclinical Alzheimer disease treatments

PubMed Central

Reiman, Eric M.; Langbaum, Jessica B.; Tariot, Pierre N.; Lopera, Francisco; Bateman, Randall J.; Morris, John C.; Sperling, Reisa A.; Aisen, Paul S.; Roses, Allen D.; Welsh-Bohmer, Kathleen A.; Carrillo, Maria C.; Weninger, Stacie

2016-01-01

If we are to find treatments to postpone, reduce the risk of, or completely prevent the clinical onset of Alzheimer disease (AD), we need faster methods to evaluate promising preclinical AD treatments, new ways to work together in support of common goals, and a determination to expedite the initiation and performance of preclinical AD trials. In this article, we note some of the current challenges, opportunities and emerging strategies in preclinical AD treatment. We describe the Collaboration for Alzheimer’s Prevention (CAP)—a convening, harmonizing and consensus-building initiative to help stakeholders advance AD prevention research with rigour, care and maximal impact—and we demonstrate the impact of CAP on the goals and design of new preclinical AD trials. PMID:26416539

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.

Ehlers-Danlos Syndrome associated with cardiomyopathy hypertrophic obstructive*

PubMed Central

Pinto, Raimundo José Almeida de Oliveira; dos Santos, Adaílton Araújo; Azevedo, Mablo de Castro; Meira, Saulo Sacramento

2015-01-01

Ehlers-Danlos syndrome is a rare clinical condition caused by a genetic change that results in the formation of structurally or functionally altered collagen. The clinical manifestations are varied, being the most obvious skin hypermotility and increased joint flexibility, although other systems - such as cardiovascular, respiratory and neurological - may also be affected. This paper presents the report of a patient who sought medical attention with complaints of atypical chest pain. Clinical evaluation enabled hypothetical diagnosis of hypertrophic obstructive cardiomyopathy and Ehlers-Danlos syndrome. Initial electrocardiogram, echocardiogram and 24 hours holter allowed the confirmation of the first hypothesis. A skin biopsy performed later associated clinical data and confirmed the second hypothesis. PMID:26312722

Mentoring Clinical Nurses to Write for Publication: Strategies for Success.

PubMed

Oman, Kathleen S; Mancuso, Mary P; Ceballos, Kirtley; Makic, MaryBeth Flynn; Fink, Regina M

2016-05-01

: Clinical nurses often find writing a challenge, but it's important to disseminate clinical practice initiatives that result in notable patient outcomes. Nurses have a responsibility to share what they do to improve patient care. The increased emphasis on the development and evaluation of evidence-based practice has made it necessary for nurses to share best practices that are associated with improved patient outcomes. We developed a six-month Writing for Publication workshop series designed to teach clinical nurses about the writing process and mentor them through the stages of preparing a manuscript to submit for publication. This successful program helped novice nurse authors become published professionals and had a great impact on our organization.

Pericarditis as presenting manifestation of acute nonlymphocytic leukemia in a young child.

PubMed

Chu, J Y; Demello, D; O'Connor, D M; Chen, S C; Gale, G B

1983-07-15

A case of acute nonlymphocytic leukemia presenting as pericarditis is reported in a five-year-old boy. Initially, a clinical diagnosis of viral pericarditis was made, because the child did not demonstrate hematologic or clinical manifestations of leukemia. Acute undifferentiated or lymphocytic leukemia. Acute undifferentiated or lymphocytic leukemia was diagnosed one week after admission when his peripheral blood count became abnormal. The patient did not respond to vincristine and prednisone. When cytochemical evaluation indicated acute myelomonocytic leukemia, employment of cytosine arabinoside and 6-thioguanine was instituted and the child began to improve. Currently, he is still in good remission and has no evidence of recurrence of pericarditis, 1 1/2 years after his initial presentation. In reviewing the literature, we found 17 patients who had leukemic pericardial effusion with cardiac tamponade. There are three reported cases of young children with pericardial effusion as the initial manifestation of acute lymphocytic leukemia, but no reported cases due to nonlymphocytic leukemia, as in this child.

Addressing Gaps in Mental Health and Addictions Nursing Leadership: An Innovative Professional Development Initiative.

PubMed

Gehrs, Margaret; Strudwick, Gillian; Ling, Sara; Reisdorfer, Emilene; Cleverley, Kristin

2017-01-01

Mental health and addictions services are integral to Canada's healthcare system, and yet it is difficult to recruit experienced nurse leaders with advanced practice, management or clinical informatics expertise in this field. Master's-level graduates, aspiring to be mental health nurse leaders, often lack the confidence and experience required to lead quality improvement, advancements in clinical care, service design and technology innovations for improved patient care. This paper describes an initiative that develops nursing leaders through a unique scholarship, internship and mentorship model, which aims to foster confidence, critical thinking and leadership competency development in the mental health and addictions context. The "Mutual Benefits Model" framework was applied in the design and evaluation of the initiative. It outlines how mentee, mentor and organizational needs can drive strategic planning of resource investment, mentorship networks and relevant leadership competency-based learning plans to optimize outcomes. Five-year individual and organizational outcomes are described. © 2017 Longwoods Publishing.

[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.

Clinical application of micro-implant anchorage in initial orthodontic retraction.

PubMed

Wahabuddin, Shaji; Mascarenhas, Rohan; Iqbal, Mahamad; Husain, Akhter

2015-02-01

Micro-implant is a device that is temporarily fixed to bone for the purpose of enhancing orthodontic anchorage either by supporting the teeth of the reactive unit or by obviating the need for the reactive unit altogether, and which is subsequently removed after use. The purpose of this study was to evaluate the clinical efficiency of micro-implants in reinforcing anchorage during the initial retraction of anterior teeth, check the rate of initial retraction for 8 weeks, and assess the stability of micro-implants during this period. Eighteen micro-implants were placed (10 in the maxilla and 8 in the mandible) and immediately loaded with 200-250 g of force using 9-mm closed coil Nitinol springs. The amount of space closure was measured every 2 weeks until the eighth week. Cephalometric measurements were made at the end of the study to evaluate anchor loss, if any. Micro-implant stability was also assessed. The rate of initial retraction in the maxilla at the end of 8 weeks was 1.65 mm/quadrant and 1.51 mm/quadrant in the mandible. The amount of retraction on the left side of the arches was 1.66 mm/quadrant and 1.49 mm/quadrant on the right side. The average initial retraction for both arches per month was 0.78 mm. An anchor loss of 0.1 mm (0.06%) was observed in the maxilla while no mandibular anchor loss was recorded. The rate of initial retraction observed in the maxilla was more than that achieved in the mandible. Initial retraction was also more on the left side of the arches. There was no anchor loss in the mandible. The micro-implant-reinforced anchorage was helpful in minimizing anchor loss and accepted heavy traction forces but did not bring about a faster rate of retraction.

Stent-assisted embolization of wide-neck anterior communicating artery aneurysms: Review of consecutive 34 cases.

PubMed

Kocur, Damian; Zbroszczyk, Miłosz; Przybyłko, Nikodem; Hofman, Mariusz; Jamróz, Tomasz; Baron, Jan; Bażowski, Piotr; Kwiek, Stanisław

We report our experience with stent-assisted coiling of anterior communicating artery aneurysms with special consideration of angiographic and clinical outcomes, retreatment rate and periprocedural complications. The analysis included 34 consecutive ruptured and unruptured wide-neck aneurysms. The aneurysm size ranged from 2 to 18mm (mean 5.47). Clinical examinations with the use of modified Rankin Score and angiographic outcomes were evaluated initially post-embolization and at a minimum follow-up of 6 months. Initial post-treatment complete and near-complete aneurysm occlusion was achieved in 32 (94%) and 2 (6%) cases, respectively. Imaging follow-up, performed in 28 (82%) patients, showed no change in the degree of occlusion in 25 (89%) cases and coil compaction in 3 (11%) patients. Of these, one (3.6%) patient underwent a second coil embolization. The periprocedural severe complication rate was 2.9% (1/35) and was associated with prolonged attempt of retrieval of migrated coil resulting in anterior cerebral artery infarct with serious clinical consequences. In another 3 patients periprocedural adverse events without delayed clinical consequences were noticed. The clinical follow-up evaluation achieved in 33 (97%) patients showed no change in 30 (91%) cases, one patient (3%) with clinical improvement and two (6%) cases of neurological deterioration. The use of stent is feasible and effective for coil embolization of wide-necked anterior communicating artery aneurysms. Although periprocedural complications resulting in severe morbidity are rare, they should be noted, since in terms of thromboembolic events some of them presumably have a potential to be avoidable. Copyright © 2016 Polish Neurological Society. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Spinal cord infarction: Clinical and imaging insights from the periprocedural setting.

PubMed

Zalewski, Nicholas L; Rabinstein, Alejandro A; Krecke, Karl N; Brown, Robert D; Wijdicks, Eelco F M; Weinshenker, Brian G; Doolittle, Derrick A; Flanagan, Eoin P

2018-05-15

Describe the range of procedures associated with spinal cord infarction (SCI) as a complication of a medical/surgical procedure and define clinical and imaging characteristics that could be applied to help diagnose spontaneous SCI, where the diagnosis is often less secure. We used an institution-based search tool to identify patients evaluated at Mayo Clinic, Rochester, MN from 1997 to 2016 with a periprocedural SCI. We performed a descriptive analysis of clinical features, MRI and other laboratory findings, and outcome. Seventy-five patients were identified with SCI related to an invasive or non-invasive surgery including: aortic aneurysm repair (49%); other aortic surgery (15%); and a variety of other procedures (e.g., cardiac surgery, spinal decompression, epidural injection, angiography, nerve block, embolization, other vascular surgery, thoracic surgery) (36%). Deficits were severe (66% para/quadriplegia) and maximal at first post-procedural evaluation in 61 patients (81%). Impaired dorsal column function was common on initial examination. Imaging features included classic findings of owl eyes or anterior pencil sign on MRI (70%), but several other T2-hyperintensity patterns were also seen. Gadolinium enhancement of the SCI and/or cauda equina was also common when assessed. Six patients (10%) had an initial normal MRI despite a severe deficit. Procedures associated with SCI are many, and this complication does not exclusively occur following aortic surgery. The clinical and radiologic findings that we describe with periprocedural SCI may be used in future studies to help distinguish spontaneous SCI from alternate causes of acute myelopathy. Copyright © 2018 Elsevier B.V. All rights reserved.

Effect of Occult Metastases on Survival in Node-Negative Breast Cancer

PubMed Central

Weaver, Donald L.; Ashikaga, Takamaru; Krag, David N.; Skelly, Joan M.; Anderson, Stewart J.; Harlow, Seth P.; Julian, Thomas B.; Mamounas, Eleftherios P.; Wolmark, Norman

2011-01-01

BACKGROUND Retrospective and observational analyses suggest that occult lymph-node metastases are an important prognostic factor for disease recurrence or survival among patients with breast cancer. Prospective data on clinical outcomes from randomized trials according to sentinel-node involvement have been lacking. METHODS We randomly assigned women with breast cancer to sentinel-lymph-node biopsy plus axillary dissection or sentinel-lymph-node biopsy alone. Paraffin-embedded tissue blocks of sentinel lymph nodes obtained from patients with pathologically negative sentinel lymph nodes were centrally evaluated for occult metastases deeper in the blocks. Both routine staining and immunohistochemical staining for cytokeratin were used at two widely spaced additional tissue levels. Treating physicians were unaware of the findings, which were not used for clinical treatment decisions. The initial evaluation at participating sites was designed to detect all macrometastases larger than 2 mm in the greatest dimension. RESULTS Occult metastases were detected in 15.9% (95% confidence interval [CI], 14.7 to 17.1) of 3887 patients. Log-rank tests indicated a significant difference between patients in whom occult metastases were detected and those in whom no occult metastases were detected with respect to overall survival (P = 0.03), disease-free survival (P = 0.02), and distant-disease–free interval (P = 0.04). The corresponding adjusted hazard ratios for death, any outcome event, and distant disease were 1.40 (95% CI, 1.05 to 1.86), 1.31 (95% CI, 1.07 to 1.60), and 1.30 (95% CI, 1.02 to 1.66), respectively. Five-year Kaplan-Meier estimates of overall survival among patients in whom occult metastases were detected and those without detectable metastases were 94.6% and 95.8%, respectively. CONCLUSIONS Occult metastases were an independent prognostic variable in patients with sentinel nodes that were negative on initial examination; however, the magnitude of the difference in outcome at 5 years was small (1.2 percentage points). These data do not indicate a clinical benefit of additional evaluation, including immunohistochemical analysis, of initially negative sentinel nodes in patients with breast cancer. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003830.) PMID:21247310

Relationship Between Mood Disturbance and Sleep Quality in Oncology Outpatients at the Initiation of Radiation Therapy

PubMed Central

Van Onselen, Christina; Dunn, Laura B.; Lee, Kathryn; Dodd, Marylin; Koetters, Theresa; West, Claudia; Paul, Steven M.; Aouizerat, Bradley E.; Wara, William; Swift, Patrick; Miaskowski, Christine

2010-01-01

Purpose of the research The purpose of this study was to describe the occurrence of significant mood disturbance and evaluate for differences in sleep quality among four mood groups (i.e., neither anxiety nor depression, only anxiety, only depression, anxiety and depression) prior to the initiation of radiation therapy (RT). Methods and sample Patients (n=179) with breast, prostate, lung, and brain cancer were evaluated prior to the initiation of RT using the Pittsburgh Sleep Quality Index (PSQI), the Center for Epidemiological Studies Depression Scale, and the Spielberger State Anxiety Inventory. Differences in sleep disturbance among the four mood groups were evaluated using analyses of variance. Key results While 38% of the patients reported some type of mood disturbance, 57% of the patients reported sleep disturbance. Patients with clinically significant levels of anxiety and depression reported the highest levels of sleep disturbance. Conclusions Overall, oncology patients with mood disturbances reported more sleep disturbance than those without mood disturbance. Findings suggest that oncology patients need to be assessed for mood and sleep disturbances. PMID:20080444

Hospitalist workload influences faculty evaluations by internal medicine clerkship students.

PubMed

Robinson, Robert L

2015-01-01

The last decade has brought significant changes to internal medicine clerkships through resident work-hour restrictions and the widespread adoption of hospitalists as medical educators. These key medical educators face competing demands for quality teaching and clinical service intensity. The study reported here was conducted to explore the relationship between clinical service intensity and teaching evaluations of hospitalists by internal medicine clerkship students. A retrospective correlation analysis of clinical service intensity and teaching evaluations of hospitalists by internal medicine clerkship students during the 2009 to 2013 academic years at Southern Illinois University School of Medicine was conducted. Internal medicine hospitalists who supervise the third-year inpatient experience for medical students during the 2009 to 2013 academic years participated in the study. Clinical service intensity data in terms of work relative value units (RVUs), patient encounters, and days of inpatient duty were collected for all members of the hospitalist service. Medical students rated hospitalists in the areas of patient rapport, enthusiasm about the profession, clinical skills, sharing knowledge and skills, encouraging the students, probing student knowledge, stimulating independent learning, providing timely feedback, providing constructive criticism, and observing patient encounters with students. Significant negative correlations between higher work RVU production, total patient encounters, duty days, and learner evaluation scores for enthusiasm about the profession, clinical skills, probing the student for knowledge and judgment, and observing a patient encounter with the student were identified. Higher duty days had a significant negative correlation with sharing knowledge/skills and encouraging student initiative. Higher work RVUs and total patient encounters were negatively correlated with timely feedback and constructive criticism. The results suggest that internal medicine clerkship student evaluations of hospitalist faculty are negatively influenced by high clinical service intensity measured in terms of annual work RVUs, patient encounters, and duty days.

Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

PubMed

Stephens, John R; Liles, E Allen; Dancel, Ria; Gilchrist, Michael; Kirsch, Jonathan; DeWalt, Darren A

2014-04-01

Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. Patients presenting for alcohol detoxification. Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

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.

Initiating Self-Assessment Strategies in Novice Physiotherapy Students: A Method Case Study

ERIC Educational Resources Information Center

Young, Catherine

2013-01-01

Student self- and peer-assessment strategies ideally are instigated early in programmes for health professionals. This study presents an innovative method of stimulating critical evaluation of clinical skills learned in the practical class setting for first year physiotherapy students. Twice in the semester (beginning and end) students assessed…

An Examination of the EeTPA Portfolio Assessment and Other Measures of Teacher Preparation and Readiness

ERIC Educational Resources Information Center

Russell, Victoria; Davidson Devall, Kelly F.

2016-01-01

The authors examined the outcomes on several measures of world language teacher preparedness, including university- and state-mandated summative evaluations and the edTPA portfolio assessment, for seven world language teacher candidates during their final semester of clinical practice. The candidates were enrolled in an initial certification…

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 and prognostic aspects of adrenocortical neoplasms in childhood.

PubMed

Teinturier, C; Pauchard, M S; Brugières, L; Landais, P; Chaussain, J L; Bougnères, P F

1999-02-01

A retrospective study of 54 children was undertaken to define the clinical presentation and secretory patterns of adrenal tumors and to evaluate the outcome of surgical resection and medical therapy. Different factors were studied in univariate and multivariate analysis by using the Cox proportional hazard model. Median age at diagnosis was 4 years. Boys and girls were affected equally. The disease was revealed by virilization (61%) or by a palpable mass (39%) with a 0.1-5.5 year delay from initial symptoms. At initial examination, we found that 76% of children were virilized. Ninety-four percent of the tested tumors secreted androgens, which were associated with glucocorticoids in 36%. Adrenal tumors in children were smaller than in adults. Half of them measured less than 10 cm. There were recurrences in 40% of children. The survival rate at 5 years was 49%, 70% if resection was microscopically complete and 7% if not (P < 0.001). In children, rare adrenal tumors have different diagnostic and prognostic characteristics than in adults; however, recurrences remain frequent. The efficacy of chemotherapy, mainly o,p'-DDD (Mitotane), remains to be evaluated in comparative trials.

Evaluation of the effect of torsemide on warfarin dosage requirements.

PubMed

Lai, Sophia; Momper, Jeremiah D; Yam, Felix K

2017-08-01

Background According to drug interaction databases, torsemide may potentiate the effects of warfarin. Evidence for this drug-drug interaction, however, is conflicting and the clinical significance is unknown. Objective The aim of this study is to evaluate the impact of torsemide initiation on warfarin dosage requirements. Setting This study was conducted at the Veterans Affairs Healthcare System in San Diego, California. Method A retrospective cohort study was conducted using Veterans Affairs data from patients who were converted from bumetanide to torsemide between March 2014 and July 2014. Patients were also prescribed and taking warfarin during the observation period. Warfarin dosage requirements were evaluated to determine if any changes occurred within the first 3 months of starting torsemide. Main outcome measure The primary outcome was the average weekly warfarin dose before and after torsemide initiation. Results Eighteen patients met study inclusion criteria. The weekly warfarin dose before and after initiation of torsemide was not significantly different (34 ± 15 and 34 ± 13 mg, p > 0.05). Of those eighteen patients, only two experienced elevations in INR that required a decrease in warfarin dosage after torsemide initiation. Between those two patients, dosage reductions ranged from 5.3 to 18%. Conclusion These results indicated that most patients did not require any warfarin dosage adjustments after torsemide was initiated. The potential for interaction, however, still exists. While empiric warfarin dosage adjustments are not recommended when initiating torsemide, increased monitoring is warranted to minimize the risk of adverse effects.

Implementation of a drug-use and disease-state management program.

PubMed

Skledar, S J; Hess, M M

2000-12-15

A drug-use and disease-state management (DUDSM) program was instituted in 1996 at a teaching hospital associated with a large nonprofit health care system. The program's goals are to optimize pharmacotherapeutic regimens, evaluate health outcomes of identified disease states, and evaluate the economic impact of pharmacotherapeutic options for given disease states by developing practice guidelines. Through a re-engineering process, resources within the pharmacy department were identified that could be devoted to the DUDSM program, including the use of clinical pharmacy specialists, promotion of staff pharmacists into the DUDSM program, a pharmacy technician, and information systems support. A strength of the program is its systematic approach for developing and implementing new initiatives, as well as monitoring compliance with all initiatives on an ongoing basis. The initiative-design process incorporates continuous quality improvement principles, outcome design and evaluation, competency assessment for all pharmacists, multidisciplinary collaboration, and sophisticated information systems. Seventy-five initiatives have been implemented, ranging from simple dose-optimization strategies for specific drugs to complicated practice guidelines for managing specific disease states. Improved patient outcomes have been documented, including reduced length of stay, postsurgical wound infection, adverse drug reactions, and medication errors. Documented cost savings exceeded $4 million annually for fiscal years 1996-97 through 1999-2000. Overall compliance with DUDSM initiatives exceeds 80%, and physician service profiling has been initiated to monitor variant prescribing. The DUDSM program has successfully integrated practice guidelines into therapeutic decision-making, resulting in improved patient-care outcomes and cost savings.

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.

Initial implementation and evaluation of a Hepatitis C treatment clinical decision support system (CDSS)

PubMed Central

Fathauer, L; Meek, J.

2012-01-01

Background Clinician compliance with clinical guidelines in the treatment of patients with Hepatitis C (HCV) has been reported to be as low as 18.5%. Treatment is complex and patient compliance is often inconsistent thus, active clinician surveillance and support is essential to successful outcomes. A clinical decision support system (CDSS) embedded within an electronic health record can provide reminders, summarize key data, and facilitate coordination of care. To date, the literature is bereft of information describing the implementation and evaluation of a CDSS to support HCV treatment. Objective The purpose of this case report is to describe the design, implementation, and initial evaluation of an HCV-specific CDSS while piloting data collection metrics and methods to be used in a larger study across multiple practices. Methods The case report describes the design and implementation processes with preliminary reporting on impact of the CDSS on quality indicator completion by comparing the pre-CDSS group to the post-CDSS group. Results The CDSS was successfully designed and implemented using an iterative, collaborative process. Pilot testing of the clinical outcomes of the CDSS revealed high rates of quality indicator completion in both the pre- and post-CDSS; although the post-CDSS group received a higher frequency of reminders (4.25 per patient) than the pre-CDSS group (.25 per patient). Conclusions This case report documents the processes used to successfully design and implement an HCV CDSS. While the small sample size precludes generalizability of findings, results did positively demonstrate the feasibility of comparing quality indicator completion rates pre-CDSS and post-CDSS. It is recommended that future studies include a larger sample size across multiple providers with expanded outcomes measures related to patient outcomes, staff satisfaction with the CDSS, and time studies to evaluate efficiency and cost effectiveness of the CDSS. PMID:23646082

Diagnosis and Management of Polycystic Ovary Syndrome in Adolescent Girls

PubMed Central

Lanzo, Erin; Monge, Maria; Trent, Maria

2017-01-01

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder in adolescent girls having both reproductive and metabolic implications. Patients with PCOS typically present to their pediatrician for evaluation of menstrual irregularity and/or signs of hyperandrogenism, such as hirsutism and acne. The diagnosis of PCOS is made by clinical symptoms and laboratory evaluation. Because of the long-term health consequences that can accompany the disorder, pediatricians should consider PCOS in their initial evaluation of menstrual irregularity. Lifestyle modification is the cornerstone of treatment for girls with PCOS, however hormonal medication such as oral contraceptive pills and insulin sensitizing agents are useful and effective adjuncts to therapy. The goals of treatment for girls with PCOS are to improve clinical manifestations of the disorder, health-related quality of life, and long-term health outcomes. PMID:26431241

Diagnosis and Management of Polycystic Ovary Syndrome in Adolescent Girls.

PubMed

Lanzo, Erin; Monge, Maria; Trent, Maria

2015-09-01

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in adolescent girls that has both reproductive and metabolic implications. Patients with PCOS typically present to their pediatrician for evaluation of menstrual irregularity and/or signs of hyperandrogenism, such as hirsutism and acne. The diagnosis of PCOS is made by clinical symptoms and laboratory evaluation. Because of the long-term health consequences that can accompany the disorder, pediatricians should consider PCOS in their initial evaluation of menstrual irregularity. Lifestyle modification is the cornerstone of treatment for girls with PCOS; however, hormonal medication such as oral contraceptive pills and insulin-sensitizing agents are useful and effective adjuncts to therapy. The goals of treatment for girls with PCOS are to improve clinical manifestations of the disorder, health-related quality of life, and long-term health outcomes. Copyright 2015, SLACK Incorporated.

Recruiting phobic research subjects: effectiveness and cost.

PubMed Central

Kaakko, T.; Murtomaa, H.; Milgrom, P.; Getz, T.; Ramsay, D. S.; Coldwell, S. E.

2001-01-01

Efficiently enrolling subjects is one of the most important and difficult aspects of a clinical trial. This prospective study evaluated strategies used in the recruitment of 144 dental injection phobics for a clinical trial evaluating the effectiveness of combining alprazolam with exposure therapy. Three types of recruitment strategies were evaluated: paid advertising, free publicity, and professional referral. Sixty-three percent of subjects were enrolled using paid advertising (the majority of them from bus advertisements [27.0%], posters on the University of Washington campus [20.1%], and newspaper advertisements [13.2%]). Free publicity (eg, television coverage, word of mouth) yielded 18.8% of enrolled subjects and professionaL referrals 14.6% of subjects. The average cost (1996 dollars) of enrolling 1 subject was $79. Bus and poster advertising attracted more initial contacts and yielded the greatest enrollment. PMID:11495403

Mechanical Model Analysis for Quantitative Evaluation of Liver Fibrosis Based on Ultrasound Tissue Elasticity Imaging

NASA Astrophysics Data System (ADS)

Shiina, Tsuyoshi; Maki, Tomonori; Yamakawa, Makoto; Mitake, Tsuyoshi; Kudo, Masatoshi; Fujimoto, Kenji

2012-07-01

Precise evaluation of the stage of chronic hepatitis C with respect to fibrosis has become an important issue to prevent the occurrence of cirrhosis and to initiate appropriate therapeutic intervention such as viral eradication using interferon. Ultrasound tissue elasticity imaging, i.e., elastography can visualize tissue hardness/softness, and its clinical usefulness has been studied to detect and evaluate tumors. We have recently reported that the texture of elasticity image changes as fibrosis progresses. To evaluate fibrosis progression quantitatively on the basis of ultrasound tissue elasticity imaging, we introduced a mechanical model of fibrosis progression and simulated the process by which hepatic fibrosis affects elasticity images and compared the results with those clinical data analysis. As a result, it was confirmed that even in diffuse diseases like chronic hepatitis, the patterns of elasticity images are related to fibrous structural changes caused by hepatic disease and can be used to derive features for quantitative evaluation of fibrosis stage.

Development of a mentorship strategy: a knowledge translation case study.

PubMed

Straus, Sharon E; Graham, Ian D; Taylor, Mark; Lockyer, Jocelyn

2008-01-01

There are many theories and frameworks for achieving knowledge translation, and the assortment can be confusing to those responsible for planning, evaluation, or policymaking in knowledge translation. A conceptual framework developed by Graham and colleagues provides an approach that builds on the commonalities found in an assessment of planned-action theories. This article describes the application of this knowledge to action framework to a mentorship initiative in academic medicine. Mentorship influences career success but is threatened in academia by increased clinical, research, and administrative demands. A case study review was undertaken of the role of mentors, the experiences of mentors and mentees, and mentorship initiatives in developing and retaining clinician scientists at two universities in Alberta, Canada. This project involved relevant stakeholders including researchers, university administrators, and research funders. The knowledge to action framework was used to develop a strategy for mentorship for clinician researchers. The framework highlights the need to identify and engage stakeholders in the process of knowledge implementation. A series of initiatives were selected and tailored to barriers and facilitators to implementation of the mentorship initiative; strategies for evaluating the knowledge use and its impact on outcomes were developed. The knowledge to action framework can be used to develop a mentorship initiative for clinician researchers. Future work to evaluate the impact of this intervention on recruitment and retention is planned.

A call for randomized controlled cost-effectiveness analysis of percutaneous transluminal coronary angioplasty.

PubMed

Holly, N

1988-01-01

A rapidly evolving technology, percutaneous transluminal coronary angioplasty, is increasingly favored over bypass surgery for treating some types of coronary stenosis because of its less traumatic invasion, better recovery response, and lower initial cost. However, substantially higher failure rates in initial procedures offset PTCA's savings to an unknown extent and cloud analysis of its overall impact. Lack of randomized clinical data precludes valid cost-effectiveness comparison of the technologies at this time. Criteria for establishing valid data and evaluations of currently available data are described in this paper.

Evaluation of Tier 5 Medical Training Initiative opportunities in dentistry.

PubMed

Wilson, M A; Burke, M

2012-03-09

This paper reviews the first two years of overseas postgraduate dental placements in the UK under the Medical Training Initiative (MTI), which is part of Tier 5 government authorised exchange. Details of the objectives of the programme, the trainees appointed, specialty areas studied and length of training are described. The methods used for assessing the training are reported. It is concluded that the objectives of the MTI have been met in dentistry and that Tier 5 provides a valuable opportunity for establishing international links in postgraduate clinical dentistry.

Leptospirosis in New Orleans.

PubMed

Toliver, Herman L; Krane, N Kevin

2014-02-01

Leptospirosis is an unusual but reemerging zoonotic infectious disease in the United States where the diagnosis may not be suspected when patients initially present. The case report of a patient from New Orleans who presented with jaundice, hypotension and acute kidney injury is presented. In this patient, a broad differential diagnosis was considered on presentation and serologic testing for leptospirosis eventually confirmed the diagnosis. A review of the clinical manifestations, diagnostic studies and treatment are discussed so that leptospirosis will be considered more carefully in the initial evaluation and management of similar patients.

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.

Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.

PubMed

Naci, Huseyin; Wouters, Olivier J; Gupta, Radhika; Ioannidis, John P A

2017-06-01

Policy Points: Randomized trials-the gold standard of evaluating effectiveness-constitute a small minority of existing evidence on agents given accelerated approval. One-third of randomized trials are in therapeutic areas outside of FDA approval and less than half evaluate the therapeutic benefits of these agents but use them instead as common backbone treatments. Agents receiving accelerated approval are often tested concurrently in several therapeutic areas. For most agents, no substantial time lag is apparent between the average start dates of randomized trials evaluating their effectiveness and those using them as part of background therapies. There appears to be a tendency for therapeutic agents receiving accelerated approval to quickly become an integral component of standard treatment, despite potential shortcomings in their evidence base. Therapeutic agents treating serious conditions are eligible for Food and Drug Administration (FDA) accelerated approval. The clinical evidence accrued on agents receiving accelerated approval has not been systematically evaluated. Our objective was to assess the timing and characteristics of available studies. We first identified clinical studies of novel therapeutic agents receiving accelerated approval. We then (1) categorized those studies as randomized or nonrandomized, (2) explored whether they evaluated the FDA-approved indications, and (3) documented the available treatment comparisons. We also meta-analyzed the difference in start times between randomized studies that (1) did or did not evaluate approved indications and (2) were or were not designed to evaluate the agent's effectiveness. In total, 37 novel therapeutic agents received accelerated approval between 2000 and 2013. Our search of ClinicalTrials.gov identified 7,757 studies, which included 1,258,315 participants. Only one-third of identified studies were randomized controlled trials. Of 1,631 randomized trials with advanced recruitment status, 906 were conducted in therapeutic areas for which agents received initial accelerated approval, 202 were in supplemental indications, and 523 were outside approved indications. Only 411 out of 906 (45.4%) trials were designed to test the effectiveness of agents that received accelerated approval ("evaluation" trials); others used these agents as common background treatment in both arms ("background" trials). There was no detectable lag between average start times of trials conducted within and outside initially approved indications. Evaluation trials started on average 1.52 years (95% CI: 0.87 to 2.17) earlier than background trials. Cumulative evidence on agents with accelerated approvals has major limitations. Most clinical studies including these agents are small and nonrandomized, and about a third are conducted in unapproved areas, typically concurrently with those conducted in approved areas. Most randomized trials including these therapeutic agents are not designed to directly evaluate their clinical benefits but to incorporate them as standard treatment. © 2017 Milbank Memorial Fund.

Evaluation of agreement among dermatologists in the assessment of the color of port wine stains and their clearance after treatment with the flashlamp-pumped dye laser.

PubMed

Pérez, B; Abraira, V; Núñez, M; Boixeda, P; Perez Corral, F; Ledo, A

1997-01-01

Color classification and its subjective clearance evaluation in response to treatment are essential in the management of patients with port wine stains (PWS). But color perception by physicians is not an objective measurement so that it can change among observers. Agreement among physicians is essential for the reliability of the color classification and the clinical assessment of the response to laser treatment. The purpose of our study was to determine the reliability of the clinical color classification of port wine stains and of their color change or clearance in response to laser treatment. The study was not designed to evaluate the outcome of laser treatment in PWS or the factors that could predict the final response. We used the kappa index to evaluate the proportion of agreement in color and clearance perception among dermatologists. Six dermatologists classified the initial color of PWS in 80 patients. Three of them also assessed the amount of clearance achieved after treatment with the flashlamp-pumped dye laser. These three dermatologists were usually dedicated to treat patients with PWS, while the other three were not. The kappa index showed a substantial agreement in both cases. No difference in the initial color perception was observed between the group of dermatologists specialized in PWS and the other three dermatologists. These results favor the reliability of the clinical method in the assessment of PWS before and after laser treatment. So, although subjective, color perception by physicians can be used in the study of laser treatment outcome in PWS and its related factors, and the results of different authors can be compared.

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

PubMed Central

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice. PMID:28182155

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. This is an observational study with prospective recruitment (May 2014-May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice.

Quadruple Inversion-Recovery b-SSFP MRA of the Abdomen: Initial Clinical Validation

PubMed Central

Atanasova, Iliyana P.; Lim, Ruth P.; Chandarana, Hersh; Storey, Pippa; Bruno, Mary T; Kim, Daniel; Lee, Vivian S.

2014-01-01

The purpose of this study is to assess the image quality and diagnostic accuracy of non-contrast quadruple inversion-recovery balanced-SSFP MRA (QIR MRA) for detection of aortoiliac disease in a clinical population. QIR MRA was performed in 26 patients referred for routine clinical gadolinium-enhanced MRA (Gd-MRA) for known or suspected aortoiliac disease. Non-contrast images were independently evaluated for image qualityand degree of stenosisby two radiologists, usingconsensus Gd-MRA as the reference standard. Hemodynamically significant stenosis (≥ 50%) was found in 10% (22/226) of all evaluable segments on Gd-MRA. The sensitivity and specificity for stenosis evaluation by QIR MRA for the two readers were 86%/86% and 95%/93% respectively. Negative predictive value and positive predictive value were 98%/98% and 63%/53% respectively. For stenosis evaluation of the aortoiliac region QIR MRA showed good agreement with the reference standard with high negative predictive value and a tendency to overestimate mild disease presumably due to the flow-dependence of the technique. QIR MRA could be a reasonable alternative to Gd-MRA for ruling out stenosis when contrast is contraindicated due to impaired kidney function or in patients who undergo abdominal MRA for screening purposes. Further work is necessary to improve performance and justify routine clinical use. PMID:24998363

Chronic Cough: Evaluation and Management.

PubMed

Michaudet, Charlie; Malaty, John

2017-11-01

Although chronic cough in adults (cough lasting longer than eight weeks) can be caused by many etiologies, four conditions account for most cases: upper airway cough syndrome, gastroesophageal reflux disease/laryngopharyngeal reflux disease, asthma, and nonasthmatic eosinophilic bronchitis. Patients should be evaluated clinically (with spirometry, if indicated), and empiric treatment should be initiated. Other potential causes include angiotensin-converting enzyme inhibitor use, environmental triggers, tobacco use, chronic obstructive pulmonary disease, and obstructive sleep apnea. Chest radiography can rule out concerning infectious, inflammatory, and malignant thoracic conditions. Patients with refractory chronic cough may warrant referral to a pulmonologist or otolaryngologist in addition to a trial of gabapentin, pregabalin, and/or speech therapy. In children, cough is considered chronic if present for more than four weeks. In children six to 14 years of age, it is most commonly caused by asthma, protracted bacterial bronchitis, and upper airway cough syndrome. Evaluation should focus initially on these etiologies, with targeted treatment and monitoring for resolution.

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.

The utility of plain radiographs in the initial evaluation of knee pain amongst sports medicine patients.

PubMed

Alaia, Michael J; Khatib, Omar; Shah, Mehul; A Bosco, Joseph; M Jazrawi, Laith; Strauss, Eric J

2015-08-01

To evaluate whether screening radiographs as part of the initial workup of knee pain impacts clinical decision-making in a sports medicine practice. A questionnaire was completed by the attending orthopaedic surgeon following the initial office visit for 499 consecutive patients presenting to the sports medicine centre with a chief complaint of knee pain. The questionnaire documented patient age, duration of symptoms, location of knee pain, associated mechanical symptoms, history of trauma within the past 2 weeks, positive findings on plain radiographs, whether magnetic resonance imaging was ordered, and whether plain radiographs impacted the management decisions for the patient. Patients were excluded if they had prior X-rays, history of malignancy, ongoing pregnancy, constitutional symptoms as well as those patients with prior knee surgery or intra-articular infections. Statistical analyses were then performed to determine which factors were more likely do correspond with diagnostic radiographs. Overall, initial screening radiographs did not change management in 72 % of the patients assessed in the office. The mean age of patients in whom radiographs did change management was 57.9 years compared to 37.1 years in those patients where plain radiograph did not change management (p < 0.0001). Plain radiographs had no impact on clinical management in 97.3 % of patients younger than 40. In patients whom radiographs did change management, radiographs were more likely to influence management if patients were over age forty, had pain for over 6 months, had medial or diffuse pain, or had mechanical symptoms. A basic cost analysis revealed that the cost of a clinically useful radiographic series in a patient under 40 years of age was $7,600, in contrast to $413 for a useful series in patients above the age of 40. Data from the current study support the hypothesis that for the younger patient population, routine radiographic imaging as a screening tool may be of little clinical benefit. Factors supporting obtaining screening radiographs include age greater than 40, knee pain for greater than 6 months, the presence of medial or diffuse knee pain, and the presence of mechanical symptoms. II.

Towards a Generalizable Time Expression Model for Temporal Reasoning in Clinical Notes

PubMed Central

Velupillai, Sumithra; Mowery, Danielle L.; Abdelrahman, Samir; Christensen, Lee; Chapman, Wendy W

2015-01-01

Accurate temporal identification and normalization is imperative for many biomedical and clinical tasks such as generating timelines and identifying phenotypes. A major natural language processing challenge is developing and evaluating a generalizable temporal modeling approach that performs well across corpora and institutions. Our long-term goal is to create such a model. We initiate our work on reaching this goal by focusing on temporal expression (TIMEX3) identification. We present a systematic approach to 1) generalize existing solutions for automated TIMEX3 span detection, and 2) assess similarities and differences by various instantiations of TIMEX3 models applied on separate clinical corpora. When evaluated on the 2012 i2b2 and the 2015 Clinical TempEval challenge corpora, our conclusion is that our approach is successful – we achieve competitive results for automated classification, and we identify similarities and differences in TIMEX3 modeling that will be informative in the development of a simplified, general temporal model. PMID:26958265

Design, Development, and Initial Evaluation of a Terminology for Clinical Decision Support and Electronic Clinical Quality Measurement.

PubMed

Lin, Yanhua; Staes, Catherine J; Shields, David E; Kandula, Vijay; Welch, Brandon M; Kawamoto, Kensaku

2015-01-01

When coupled with a common information model, a common terminology for clinical decision support (CDS) and electronic clinical quality measurement (eCQM) could greatly facilitate the distributed development and sharing of CDS and eCQM knowledge resources. To enable such scalable knowledge authoring and sharing, we systematically developed an extensible and standards-based terminology for CDS and eCQM in the context of the HL7 Virtual Medical Record (vMR) information model. The development of this terminology entailed three steps: (1) systematic, physician-curated concept identification from sources such as the Health Information Technology Standards Panel (HITSP) and the SNOMED-CT CORE problem list; (2) concept de-duplication leveraging the Unified Medical Language System (UMLS) MetaMap and Metathesaurus; and (3) systematic concept naming using standard terminologies and heuristic algorithms. This process generated 3,046 concepts spanning 68 domains. Evaluation against representative CDS and eCQM resources revealed approximately 50-70% concept coverage, indicating the need for continued expansion of the terminology.

Design, Development, and Initial Evaluation of a Terminology for Clinical Decision Support and Electronic Clinical Quality Measurement

PubMed Central

Lin, Yanhua; Staes, Catherine J; Shields, David E; Kandula, Vijay; Welch, Brandon M; Kawamoto, Kensaku

2015-01-01

When coupled with a common information model, a common terminology for clinical decision support (CDS) and electronic clinical quality measurement (eCQM) could greatly facilitate the distributed development and sharing of CDS and eCQM knowledge resources. To enable such scalable knowledge authoring and sharing, we systematically developed an extensible and standards-based terminology for CDS and eCQM in the context of the HL7 Virtual Medical Record (vMR) information model. The development of this terminology entailed three steps: (1) systematic, physician-curated concept identification from sources such as the Health Information Technology Standards Panel (HITSP) and the SNOMED-CT CORE problem list; (2) concept de-duplication leveraging the Unified Medical Language System (UMLS) MetaMap and Metathesaurus; and (3) systematic concept naming using standard terminologies and heuristic algorithms. This process generated 3,046 concepts spanning 68 domains. Evaluation against representative CDS and eCQM resources revealed approximately 50–70% concept coverage, indicating the need for continued expansion of the terminology. PMID:26958220

[Use of the reliable change index to evaluate the effectiveness of clinical interventions: Application of an asthma training program].

PubMed

Montero, Mikel; Iraurgi, Ioseba; Matellanes, Begoña; Montero, José Manuel

2015-12-01

To compare two methods for the evaluation of outcomes to assess effectiveness of a therapeutic intervention of a professional education program on asthma control. A naturalistic, intervention study in which asthmatic patients were attended by clinicians (IG group) who Had taken part in a special education program and a control group (CG) that received medical assistance from clinicians still waiting to be trained. Five urban Primary Care Health Centres of the same region. From an initial sample of 100 patients, 76 formed the final sample for analysis. The study included 37 males and 39 females, aged between 18 and 65 years (M=41.2 years). The two study groups were found to be homogeneous except for the sex variable. Training program for clinical treatment adherence. Peak flow as spirometric index, and structured interview. The results were initially analysed using classical techniques based on robust ANOVA models, and then by calculating the Reliable Change Index (RCI). ANOVA models, conducted separately for each sex, showed no significant differences, due to sample size. RCI methodology showed significant differences in the percentage of patients improved in both groups, as well as clinically relevant changes being observed individually. The RCI method is presented as an attractive alternative as regards the classical methods of analysis that can help in the clinical decision. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Advances in Patient-Reported Outcomes: The NIH PROMIS® Measures

PubMed Central

Broderick, Joan E.; DeWitt, Esi Morgan; Rothrock, Nan; Crane, Paul K.; Forrest, Christopher B.

2013-01-01

Patient-reported outcomes (PRO) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient-Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed by using contemporary psychometric methods, yielding rapid, accurate measurements. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer-adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience in order to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. PROs could also potentially improve quality of care and disease outcomes, provide patient-centered assessment for comparative effectiveness research, and enable a common metric for tracking outcomes across providers and medical systems. PMID:25848562

Implementation of a Mobile Clinical Decision Support Application to Augment Local Antimicrobial Stewardship.

PubMed

Hoff, Brian M; Ford, Diana C; Ince, Dilek; Ernst, Erika J; Livorsi, Daniel J; Heintz, Brett H; Masse, Vincent; Brownlee, Michael J; Ford, Bradley A

2018-01-01

Medical applications for mobile devices allow clinicians to leverage microbiological data and standardized guidelines to treat patients with infectious diseases. We report the implementation of a mobile clinical decision support (CDS) application to augment local antimicrobial stewardship. We detail the implementation of our mobile CDS application over 20 months. Application utilization data were collected and evaluated using descriptive statistics to quantify the impact of our implementation. Project initiation focused on engaging key stakeholders, developing a business case, and selecting a mobile platform. The preimplementation phase included content development, creation of a pathway for content approval within the hospital committee structure, engaging clinical leaders, and formatting the first version of the guide. Implementation involved a media campaign, staff education, and integration within the electronic medical record and hospital mobile devices. The postimplementation phase required ongoing quality improvement, revision of outdated content, and repeated staff education. The evaluation phase included a guide utilization analysis, reporting to hospital leadership, and sustainability and innovation planning. The mobile application was downloaded 3056 times and accessed 9259 times during the study period. The companion web viewer was accessed 8214 times. Successful implementation of a customizable mobile CDS tool enabled our team to expand beyond microbiological data to clinical diagnosis, treatment, and antimicrobial stewardship, broadening our influence on antimicrobial prescribing and incorporating utilization data to inspire new quality and safety initiatives. Further studies are needed to assess the impact on antimicrobial utilization, infection control measures, and patient care outcomes.

Critical factors for the success of orthodontic mini-implants: a systematic review.

PubMed

Chen, Yan; Kyung, Hee Moon; Zhao, Wen Ting; Yu, Won Jae

2009-03-01

This systematic review was undertaken to discuss factors that affect mini-implants as direct and indirect orthodontic anchorage. The data were collected from electronic databases (Medline [Entrez PubMed], Embase, Web of Science, Cochrane Library, and All Evidence Based Medicine Reviews). Randomized clinical trials, prospective and retrospective clinical studies, and clinical trials concerning the properties, affective factors, and requirements of mini-implants were considered. The titles and abstracts that appeared to fulfill the initial selection criteria were collected by consensus, and the original articles were retrieved and evaluated with a methodologic checklist. A hand search of key orthodontic journals was performed to identify recent unindexed literature. The search strategy resulted in 596 articles. By screening titles and abstracts, 126 articles were identified. After the exclusion criteria were applied, 16 articles remained. The analyzed results of the literature were divided into 2 topics: placement-related and loading-related factors. Mini-implants are effective as anchorage, and their success depends on proper initial mechanical stability and loading quality and quantity.

Potential use of biomarkers in acute kidney injury: report and summary of recommendations from the 10th Acute Dialysis Quality Initiative consensus conference.

PubMed

Murray, Patrick T; Mehta, Ravindra L; Shaw, Andrew; Ronco, Claudio; Endre, Zoltan; Kellum, John A; Chawla, Lakhmir S; Cruz, Dinna; Ince, Can; Okusa, Mark D

2014-03-01

Over the last decade there has been considerable progress in the discovery and development of biomarkers of kidney disease, and several have now been evaluated in different clinical settings. Although there is a growing literature on the performance of various biomarkers in clinical studies, there is limited information on how these biomarkers would be utilized by clinicians to manage patients with acute kidney injury (AKI). Recognizing this gap in knowledge, we convened the 10th Acute Dialysis Quality Initiative meeting to review the literature on biomarkers in AKI and their application in clinical practice. We asked an international group of experts to assess four broad areas for biomarker utilization for AKI: risk assessment, diagnosis, and staging; differential diagnosis; prognosis and management; and novel physiological techniques including imaging. This article provides a summary of the key findings and recommendations of the group, to equip clinicians to effectively use biomarkers in AKI.

Children With Medical Complexity: An Emerging Population for Clinical and Research Initiatives

PubMed Central

Kuo, Dennis Z.; Agrawal, Rishi; Berry, Jay G.; Bhagat, Santi K. M.; Simon, Tamara D.; Srivastava, Rajendu

2011-01-01

Children with medical complexity (CMC) have medical fragility and intensive care needs that are not easily met by existing health care models. CMC may have a congenital or acquired multisystem disease, a severe neurologic condition with marked functional impairment, and/or technology dependence for activities of daily living. Although these children are at risk of poor health and family outcomes, there are few well-characterized clinical initiatives and research efforts devoted to improving their care. In this article, we present a definitional framework of CMC that consists of substantial family-identified service needs, characteristic chronic and severe conditions, functional limitations, and high health care use. We explore the diversity of existing care models and apply the principles of the chronic care model to address the clinical needs of CMC. Finally, we suggest a research agenda that uses a uniform definition to accurately describe the population and to evaluate outcomes from the perspectives of the child, the family, and the broader health care system. PMID:21339266

Improving quality through performance-based financing in district hospitals in Rwanda between 2006 and 2010: a 5-year experience.

PubMed

Janssen, Willy; Ngirabega, Jean de Dieu; Matungwa, Michel; Van Bastelaere, Stefaan

2015-01-01

Since 2000 performance-based financing (PBF) made its way to sub-Saharan health systems in an attempt to improve service delivery. In Rwanda initial experiences in 2001 and 2002 led to a scaling up of the initiative to all health centres (HC) and district hospitals (DH). In 2008 PBF became national strategy. PBF was introduced in Rwanda in 2006 at the DH level. Evaluation on their service delivery was carried out quarterly in the following areas: hospital management, support to the health centres and clinical activities. We studied four DHs. After 5 years, an improvement in the quantity of clinical activities was observed, as well as quality in hospital management, in HC support and in clinical activities. PBF proves to be a promising approach in strengthening and maintaining quality service delivery in the sub-Saharan district hospitals. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Working together: a joint initiative between academics and clinicians to prepare undergraduate nursing students to work in mental health settings.

PubMed

Curtis, Janette

2007-08-01

There is ongoing concern among mental health professionals regarding the recruitment of newly graduated nurses to this specialist nursing area. Many reasons for the problem have been identified, including the perceived inadequate preparation by the tertiary sector, students' prejudices and anxieties about mental illness, a perceived lack of support while undertaking clinical placement, and the quality of the clinical placement itself. This paper describes a collaborative response to these issues undertaken in the Illawarra region of New South Wales, Australia. The implementation of preclinical undergraduate workshops using problem-based learning and role plays were undertaken. Mental health nursing scenarios were developed in association with experienced clinicians to introduce core concepts in a supportive learning environment. Quantitative and qualitative evaluation data were collected immediately following the workshop and again after the students returned to the university following a mental health clinical placement. A further survey of one cohort was undertaken 12 months after initial state registration and the beginning of a career in mental health nursing. Results showed that both students' and clinicians' attitudes to the workshops were consistently positive and indicated that the workshops were beneficial in preparing students for their clinical placement. Importantly, since the implementation of the workshops and other collaborative initiatives, an increasing number of newly graduated nurses from the region are choosing to work in mental health.

Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate.

PubMed

Mayer, Lori; Fink, Mary Kay; Sammarco, Carrie; Laing, Lisa

2018-04-01

Delayed-release dimethyl fumarate is an oral disease-modifying therapy that has demonstrated significant efficacy in adults with relapsing-remitting multiple sclerosis. Incidences of flushing and gastrointestinal adverse events are common in the first month after delayed-release dimethyl fumarate initiation. Our objective was to propose mitigation strategies for adverse events related to initiation of delayed-release dimethyl fumarate in the treatment of patients with multiple sclerosis. Studies of individually developed mitigation strategies and chart reviews were evaluated. Those results, as well as mitigation protocols developed at multiple sclerosis care centers, are summarized. Key steps to optimize the effectiveness of delayed-release dimethyl fumarate treatment include education prior to and at the time of delayed-release dimethyl fumarate initiation, initiation dose protocol gradually increasing to maintenance dose, dietary suggestions for co-administration with food, gastrointestinal symptom management with over-the-counter medications, flushing symptom management with aspirin, and temporary dose reduction. Using the available evidence from clinical trials and evaluations of post-marketing studies, these strategies to manage gastrointestinal and flushing symptoms can be effective and helpful to the patient when initiating delayed-release dimethyl fumarate.

Social franchising primary healthcare clinics--a model for South African National Health Insurance?

PubMed

Robinson, Andrew Ken Lacey

2015-09-21

This article describes the first government social franchise initiative in the world to deliver a 'brand' of quality primary healthcare (PHC) clinic services. Quality and standards of care are not uniformly and reliably delivered across government PHC clinics in North West Province, South Africa, despite government support, numerous policies, guidelines and in-service training sessions provided to staff. Currently the strongest predictor of good-quality service is the skill and dedication of the facility manager. A project utilising the social franchising business model, harvesting best practices, has been implemented with the aim of developing a system to ensure reliably excellent healthcare service provision in every facility in North West. The services of social franchising consultants have been procured to develop the business model to drive this initiative. Best practices have been benchmarked, and policies, guidelines and clinic support systems have been reviewed, evaluated and assessed, and incorporated into the business plan. A pilot clinic has been selected to refine and develop a working social franchise model. This will then be replicated in one clinic to confirm proof of concept before further scale-up. The social franchise business model can provide solutions to a reliable and recognisable 'brand' of quality universal coverage of healthcare services.

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.

PubMed

Knirsch, Charles; Alemayehu, Demissie; Botgros, Radu; Comic-Savic, Sabrina; Friedland, David; Holland, Thomas L; Merchant, Kunal; Noel, Gary J; Pelfrene, Eric; Reith, Christina; Santiago, Jonas; Tiernan, Rosemary; Tenearts, Pamela; Goldsack, Jennifer C; Fowler, Vance G

2016-08-15

The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrug-resistant infections. The evaluation of new antibacterial drugs for efficacy in this population is important, as many antibacterial drugs have demonstrated limitations when studied in this population. HABP/VABP trials are expensive and challenging to conduct due to protocol complexity and low patient enrollment, among other factors. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development by streamlining HABP/VABP clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with HABP/VABP protocol complexity. The Project Team developed potential solutions to streamline HABP/VABP trials using a Quality by Design approach. CTTI recommendations focus on 4 key areas to improve HABP/VABP trials: informed consent processes/practices, protocol design, choice of an institutional review board (IRB), and trial outcomes. Informed consent processes should include legally authorized representatives. Protocol design decisions should focus on eligibility criteria, prestudy antibacterial therapy considerations, use of new diagnostics, and sample size. CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, including defining a clinical failure and evaluating the impact of concomitant antibacterial drugs. Streamlining HABP/VABP trials by addressing key protocol elements can improve trial startup and patient recruitment/retention, reduce trial complexity and costs, and ensure patient safety while advancing antibacterial drug development. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Microscopic Colitis – A Missed Diagnosis in Diarrhea-Predominant Irritable Bowel Syndrome

PubMed Central

STOICESCU, Adriana; BECHEANU, Gabriel; DUMBRAVA, Mona; GHEORGHE, Cristian; DICULESCU, Mircea

2012-01-01

ABSTRACT Background: Clinical presentation in microscopic colitis (MC) is similar in many cases to that of diarrhea-predominent irritable bowel syndrome (IBS-D). The proper differential diagnosis requires total colonoscopy with multiple biopsies from normal-appearing mucosa and a detailed histopathological exam. Specific treatment may improve symptomatology. Aim: To evaluate the prevalence of MC in patients with an initial diagnosis of IBS-D, to analyse demographic and clinical features of MC patients and to assess the efficacy of specific treatment. Material and methods: Our retrospective study analyzed patients diagnosed with microscopic colitis in clinic during a three-year period. Diagnosis was established on histological exams of the samples obtained during colonoscopy in patients previously thought to have IBS-D. We evaluated clinical manifestations, time lapsed from their onset to definitive diagnosis, the association of MC with autoimmune diseases or with prior medication and the efficacy of treatment with budesonide or mesalazine. Results: From 247 patients considered to have IBS-D, 15 patients (6.07%) had actually MC (13 lymphocytic colitis and 2 collagenous colitis). MC was associated with nonsteroidal antiinflammatory drugs (3 patients), Lansoprazole (2 patients) and autoimmune diseases (6 patients). Watery, non-bloody diarrhea was present in all patients with MC. Other frequent complaints were nocturnal diarrhea (11 patients), abdominal pain (8 patients), abdominal bloating and flatulence (8 patients) and slight weight loss (6 patients). The diagnostic samples were obtained from the right colon in 6 cases and from rectosigmoid or transverse colon in 9 patients. Treatment was initial symptomatic in all patients, but there were 5 patients that required mesalazine and/or Budesonide, with favourable outcome. Conclusions: All the patients thought to have diarrhea-irritable bowel syndrome should be evaluated for microscopic colitis. Symptomatology is almost superimposable, but a few distinct features can be noticed. The proper and early diagnosis and the specific treatment may lead to significant clinical improvement in some difficult cases of the so-called "irritable bowel syndrome". PMID:23118812

Microscopic colitis - a missed diagnosis in diarrhea-predominant irritable bowel syndrome.

PubMed

Stoicescu, Adriana; Becheanu, Gabriel; Dumbrava, Mona; Gheorghe, Cristian; Diculescu, Mircea

2012-01-01

Clinical presentation in microscopic colitis (MC) is similar in many cases to that of diarrhea-predominent irritable bowel syndrome (IBS-D). The proper differential diagnosis requires total colonoscopy with multiple biopsies from normal-appearing mucosa and a detailed histopathological exam. Specific treatment may improve symptomatology. To evaluate the prevalence of MC in patients with an initial diagnosis of IBS-D, to analyse demographic and clinical features of MC patients and to assess the efficacy of specific treatment. Our retrospective study analyzed patients diagnosed with microscopic colitis in clinic during a three-year period. Diagnosis was established on histological exams of the samples obtained during colonoscopy in patients previously thought to have IBS-D. We evaluated clinical manifestations, time lapsed from their onset to definitive diagnosis, the association of MC with autoimmune diseases or with prior medication and the efficacy of treatment with budesonide or mesalazine. From 247 patients considered to have IBS-D, 15 patients (6.07%) had actually MC (13 lymphocytic colitis and 2 collagenous colitis). MC was associated with nonsteroidal antiinflammatory drugs (3 patients), Lansoprazole (2 patients) and autoimmune diseases (6 patients). Watery, non-bloody diarrhea was present in all patients with MC. Other frequent complaints were nocturnal diarrhea (11 patients), abdominal pain (8 patients), abdominal bloating and flatulence (8 patients) and slight weight loss (6 patients). The diagnostic samples were obtained from the right colon in 6 cases and from rectosigmoid or transverse colon in 9 patients. Treatment was initial symptomatic in all patients, but there were 5 patients that required mesalazine and/or Budesonide, with favourable outcome. All the patients thought to have diarrhea-irritable bowel syndrome should be evaluated for microscopic colitis. Symptomatology is almost superimposable, but a few distinct features can be noticed. The proper and early diagnosis and the specific treatment may lead to significant clinical improvement in some difficult cases of the so-called "irritable bowel syndrome".

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.

Economic evaluation of prescribing conventional and newer oral anticoagulants in older adults.

PubMed

Hasan, Syed Shahzad; Kow, Chia Siang; Curley, Louise E; Baines, Darrin L; Babar, Zaheer-Ud-Din

2018-05-09

Anticoagulants refer to a variety of agents that inhibit one or more steps in the coagulation cascade. Generally, clinical conditions that require the prescribing of an oral anticoagulant increase in frequency with age. However, a major challenge of anticoagulation use among older patients is that this group of patients also experience the highest bleeding risk. To date, economic evaluation of prescribing of anticoagulants that includes the novel or newer oral anticoagulants (NOACs) in older adults has not been conducted and is warranted. Areas covered: A review of articles that evaluated the cost of prescribing conventional (e.g. vitamin K antagonists) and NOACs (e.g. direct thrombin inhibitors and direct factor Xa inhibitors) in older adults. Expert commentary: While the use of NOACs significantly increases the cost of the initial treatment for thromboembolic disorders, they are still considered cost-effective relative to warfarin since they offer reduced risk of intracranial haemorrhagic events. The optimum anticoagulation with warfarin can be achieved by providing specialised care; clinics managed by pharmacists have been shown to be cost-effective relative to usual care. There are suggestions that genotyping the CYP2C9 and VKORC1 genes is useful for determining a more appropriate initial dose and thereby increasing the effectiveness and safety of warfarin.

Evaluation of high fidelity patient simulator in assessment of performance of anaesthetists.

PubMed

Weller, J M; Bloch, M; Young, S; Maze, M; Oyesola, S; Wyner, J; Dob, D; Haire, K; Durbridge, J; Walker, T; Newble, D

2003-01-01

There is increasing emphasis on performance-based assessment of clinical competence. The High Fidelity Patient Simulator (HPS) may be useful for assessment of clinical practice in anaesthesia, but needs formal evaluation of validity, reliability, feasibility and effect on learning. We set out to assess the reliability of a global rating scale for scoring simulator performance in crisis management. Using a global rating scale, three judges independently rated videotapes of anaesthetists in simulated crises in the operating theatre. Five anaesthetists then independently rated subsets of these videotapes. There was good agreement between raters for medical management, behavioural attributes and overall performance. Agreement was high for both the initial judges and the five additional raters. Using a global scale to assess simulator performance, we found good inter-rater reliability for scoring performance in a crisis. We estimate that two judges should provide a reliable assessment. High fidelity simulation should be studied further for assessing clinical performance.

WIC-based interventions to promote breastfeeding among African-American Women in Baltimore: effects on breastfeeding initiation and continuation.

PubMed

Caulfield, L E; Gross, S M; Bentley, M E; Bronner, Y; Kessler, L; Jensen, J; Weathers, B; Paige, D M

1998-03-01

We evaluated the single and combined effects of introducing a motivational video and peer counseling into four matched WIC clinics on breastfeeding initiation and continuation at 7-10 days among African-American WIC participants. Of the 242 women with complete data, 48% initiated breastfeeding, but only 31% were still breastfeeding at 7-10 days. Initiation was associated with cesarean delivery, infant feeding instruction, no artificial milk discharge pack, attending the peer counselor only-intervention site, and intention to breastfeed. Continuation was influenced by infant feeding instruction, no artificial milk discharge pack, and intention to breastfeed. Overall, trends toward a positive impact of the breastfeeding promotion activities were evident but weak, and largely gone by 7-10 days postpartum.

Development of a novel imaging informatics-based system with an intelligent workflow engine (IWEIS) to support imaging-based clinical trials

PubMed Central

Wang, Ximing; Liu, Brent J; Martinez, Clarisa; Zhang, Xuejun; Winstein, Carolee J

2015-01-01

Imaging based clinical trials can benefit from a solution to efficiently collect, analyze, and distribute multimedia data at various stages within the workflow. Currently, the data management needs of these trials are typically addressed with custom-built systems. However, software development of the custom- built systems for versatile workflows can be resource-consuming. To address these challenges, we present a system with a workflow engine for imaging based clinical trials. The system enables a project coordinator to build a data collection and management system specifically related to study protocol workflow without programming. Web Access to DICOM Objects (WADO) module with novel features is integrated to further facilitate imaging related study. The system was initially evaluated by an imaging based rehabilitation clinical trial. The evaluation shows that the cost of the development of system can be much reduced compared to the custom-built system. By providing a solution to customize a system and automate the workflow, the system will save on development time and reduce errors especially for imaging clinical trials. PMID:25870169

Clinical audit in dentistry: From a concept to an initiation.

PubMed

Malleshi, Suchetha N; Joshi, Mahasweta; Nair, Soumya K; Ashraf, Irshad

2012-11-01

Clinical audit is a quality improvement process that aims to improve patient care through a systematic review of care against explicit criteria. It is a cyclic and multidisciplinary process which involves a series of steps from planning the audit through measuring the performance to implementing and sustaining the change. Although audit contains some facets of research, it is essential to understand the difference between the two. Auditing can be done right from the record maintaining, diagnosis and treatment and postoperative evaluation and follow-up. The immense potential of clinical audit can be utilized only when open-mindedness and innovativeness are encouraged and evidence-based work culture is cultivated.

Fiberoptic endoscopic evaluation of swallowing in intensive care unit patients

PubMed Central

Hafner, Gert; Neuhuber, Andreas; Hirtenfelder, Sylvia; Schmedler, Brigitte

2007-01-01

Aspiration in critically ill patients frequently causes severe co-morbidity. We evaluated a diagnostic protocol using routine FEES in critically ill patients at risk to develop aspiration following extubation. We instructed intensive care unit physicians on specific risk factors for and clinical signs of aspiration following extubation in critically ill patients and offered bedside FEES for such patients. Over a 45-month period, we were called to perform 913 endoscopic examinations in 553 patients. Silent aspiration or aspiration with acute symptoms (cough or gag reflex as the bolus passed into the trachea) was detected in 69.3% of all patients. Prolonged non-oral feeding via a naso-gastric tube was initiated in 49.7% of all patients. In 13.2% of patients, a percutaneous endoscopic gastrostomy was initiated as a result of FEES findings, and in 6.3% an additional tracheotomy to prevent aspiration had to be initiated. In 59 out of 258 patients (22.9%), tracheotomies were closed, and 30.7% of all 553 patients could be managed with the immediate onset of an oral diet and compensatory treatment procedures. Additional radiological examinations were not required. FEES in critically ill patients allows for a rapid evaluation of deglutition and for the immediate initiation of symptom-related rehabilitation or for an early resumption of oral feeding. PMID:17968575

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.

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.

Incidence and timing of cancer in HIV-infected individuals following initiation of combination antiretroviral therapy.

PubMed

Yanik, Elizabeth L; Napravnik, Sonia; Cole, Stephen R; Achenbach, Chad J; Gopal, Satish; Olshan, Andrew; Dittmer, Dirk P; Kitahata, Mari M; Mugavero, Michael J; Saag, Michael; Moore, Richard D; Mayer, Kenneth; Mathews, W Christopher; Hunt, Peter W; Rodriguez, Benigno; Eron, Joseph J

2013-09-01

Cancer is an important cause of morbidity and mortality in individuals infected with human immunodeficiency virus (HIV), but patterns of cancer incidence after combination antiretroviral therapy (ART) initiation remain poorly characterized. We evaluated the incidence and timing of cancer diagnoses among patients initiating ART between 1996 and 2011 in a collaboration of 8 US clinical HIV cohorts. Poisson regression was used to estimate incidence rates. Cox regression was used to identify demographic and clinical characteristics associated with cancer incidence after ART initiation. At initiation of first combination ART among 11 485 patients, median year was 2004 (interquartile range [IQR], 2000-2007) and median CD4 count was 202 cells/mm(3) (IQR, 61-338). Incidence rates for Kaposi sarcoma (KS) and lymphomas were highest in the first 6 months after ART initiation (P < .001) and plateaued thereafter, while incidence rates for all other cancers combined increased from 416 to 615 cases per 100 000 person-years from 1 to 10 years after ART initiation (average 7% increase per year; 95% confidence interval, 2%-13%). Lower CD4 count at ART initiation was associated with greater risk of KS, lymphoma, and human papillomavirus-related cancer. Calendar year of ART initiation was not associated with cancer incidence. KS and lymphoma rates were highest immediately following ART initiation, particularly among patients with low CD4 cell counts, whereas other cancers increased with time on ART, likely reflecting increased cancer risk with aging. Our results underscore recommendations for earlier HIV diagnosis followed by prompt ART initiation along with ongoing aggressive cancer screening and prevention efforts throughout the course of HIV care.

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

Association of Medical Liability Reform With Clinician Approach to Coronary Artery Disease Management.

PubMed

Farmer, Steven A; Moghtaderi, Ali; Schilsky, Samantha; Magid, David; Sage, William; Allen, Nori; Masoudi, Frederick A; Dor, Avi; Black, Bernard

2018-06-06

Physicians often report practicing defensive medicine to reduce malpractice risk, including performing expensive but marginally beneficial tests and procedures. Although there is little evidence that malpractice reform affects overall health care spending, it may influence physician behavior for specific conditions involving clinical uncertainty. To examine whether reducing malpractice risk is associated with clinical decisions involving coronary artery disease testing and treatment. Difference-in-differences design, comparing physician-specific changes in coronary artery disease testing and treatment in 9 new-cap states that adopted damage caps between 2003 and 2005 with 20 states without caps. We used the 5% national Medicare fee-for-service random sample between 1999 and 2013. Physicians (n = 75 801; 36 647 in new-cap states) who ordered or performed 2 or more coronary angiographies. Data were analyzed from June 2015 to January 2018. Changes in ischemic evaluation rates for possible coronary artery disease, type of initial evaluation (stress testing or coronary angiography), progression from stress test to angiography, and progression from ischemic evaluation to revascularization (percutaneous coronary intervention or coronary artery bypass grafting). We studied 36 647 physicians in new-cap states and 39 154 physicians in no-cap states. New-cap states had younger populations, more minorities, lower per-capita incomes, fewer physicians per capita, and lower managed care penetration. Following cap adoption, new-cap physicians reduced invasive testing (angiography) as a first diagnostic test compared with control physicians (relative change, -24%; 95% CI, -40% to -7%; P = .005) with an offsetting increase in noninvasive stress testing (7.8%; 95% CI, -3.6% to 19.3%; P = .17), and referred fewer patients for angiography following stress testing (-21%; 95% CI, -40% to -2%; P = .03). New-cap physicians also reduced revascularization rates after ischemic evaluation (-23%; 95% CI, -40% to -4%; P = .02; driven by fewer percutaneous coronary interventions). Changes in overall ischemic evaluation rates were similar for new-cap and control physicians (-0.05%; 95% CI, -8.0% to 7.9%; P = .98). Physicians substantially altered their approach to coronary artery disease testing and follow-up after initial ischemic evaluations following adoption of damage caps. They performed a similar number of ischemic evaluations but conducted fewer initial left heart catheterizations, referred fewer stress-tested patients for left heart catheterizations, and referred fewer patients for revascularization. These findings suggest that physicians tolerate greater clinical uncertainty in coronary artery disease testing and treatment if they face lower malpractice risk.

Delayed risk stratification, to include the response to initial treatment (surgery and radioiodine ablation), has better outcome predictivity in differentiated thyroid cancer patients.

PubMed

Castagna, Maria Grazia; Maino, Fabio; Cipri, Claudia; Belardini, Valentina; Theodoropoulou, Alexandra; Cevenini, Gabriele; Pacini, Furio

2011-09-01

After initial treatment, differentiated thyroid cancer (DTC) patients are stratified as low and high risk based on clinical/pathological features. Recently, a risk stratification based on additional clinical data accumulated during follow-up has been proposed. To evaluate the predictive value of delayed risk stratification (DRS) obtained at the time of the first diagnostic control (8-12 months after initial treatment). We reviewed 512 patients with DTC whose risk assessment was initially defined according to the American (ATA) and European Thyroid Association (ETA) guidelines. At the time of the first control, 8-12 months after initial treatment, patients were re-stratified according to their clinical status: DRS. Using DRS, about 50% of ATA/ETA intermediate/high-risk patients moved to DRS low-risk category, while about 10% of ATA/ETA low-risk patients moved to DRS high-risk category. The ability of the DRS to predict the final outcome was superior to that of ATA and ETA. Positive and negative predictive values for both ATA (39.2 and 90.6% respectively) and ETA (38.4 and 91.3% respectively) were significantly lower than that observed with the DRS (72.8 and 96.3% respectively, P<0.05). The observed variance in predicting final outcome was 25.4% for ATA, 19.1% for ETA, and 62.1% for DRS. Delaying the risk stratification of DTC patients at a time when the response to surgery and radioiodine ablation is evident allows to better define individual risk and to better modulate the subsequent follow-up.

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.

Meeting the challenge of assessing clinical competence of occupational therapists within a program management environment.

PubMed

Salvatori, Penny; Simonavicius, Nijole; Moore, Joan; Rimmer, Georgina; Patterson, Michele

2008-02-01

Program management models have raised concerns among occupational therapists about professional standards related to clinical competence, performance review procedures, and quality improvement initiatives. This paper describes how a chart-stimulated recall (CSR) peer-review process and interview tool was revised, implemented, and evaluated as a pilot project to assess the clinical competence of occupational therapy staff at a large urban health centre in southern Ontario. Fourteen pairs (n=28) of occupational therapists representing various practice areas participated in this project. Half served as peer assessors and half as interviewees. Peer assessors conducted an independent chart review followed by a one-hour personal interview with a peer partner to discuss clinical management issues related to the client cases. Each interviewer rated his or her partner's clinical competence in eight areas of performance using a 7-point Likert scale. Results indicated that the CSR tool could discriminate among occupational therapists in terms of overall levels of clinical competence and also identify specific areas of concern that could be targeted for professional development. Feedback from participants was positive. The CSR tool was found to be useful for assessing clinical competence of occupational therapists in this large health centre as a quality improvement initiative within that discipline group. Further research is needed to establish the reliability and validity of the CSR tool.

Using antibiograms to improve antibiotic prescribing in skilled nursing facilities.

PubMed

Furuno, Jon P; Comer, Angela C; Johnson, J Kristie; Rosenberg, Joseph H; Moore, Susan L; MacKenzie, Thomas D; Hall, Kendall K; Hirshon, Jon Mark

2014-10-01

Antibiograms have effectively improved antibiotic prescribing in acute-care settings; however, their effectiveness in skilled nursing facilities (SNFs) is currently unknown. To develop SNF-specific antibiograms and identify opportunities to improve antibiotic prescribing. Cross-sectional and pretest-posttest study among residents of 3 Maryland SNFs. Antibiograms were created using clinical culture data from a 6-month period in each SNF. We also used admission clinical culture data from the acute care facility primarily associated with each SNF for transferred residents. We manually collected all data from medical charts, and antibiograms were created using WHONET software. We then used a pretest-posttest study to evaluate the effectiveness of an antibiogram on changing antibiotic prescribing practices in a single SNF. Appropriate empirical antibiotic therapy was defined as an empirical antibiotic choice that sufficiently covered the infecting organism, considering antibiotic susceptibilities. We reviewed 839 patient charts from SNF and acute care facilities. During the initial assessment period, 85% of initial antibiotic use in the SNFs was empirical, and thus only 15% of initial antibiotics were based on culture results. Fluoroquinolones were the most frequently used empirical antibiotics, accounting for 54.5% of initial prescribing instances. Among patients with available culture data, only 35% of empirical antibiotic prescribing was determined to be appropriate. In the single SNF in which we evaluated antibiogram effectiveness, prevalence of appropriate antibiotic prescribing increased from 32% to 45% after antibiogram implementation; however, this was not statistically significant ([Formula: see text]). Implementation of antibiograms may be effective in improving empirical antibiotic prescribing in SNFs.

Pros-IT CNR: an Italian prostate cancer monitoring project.

PubMed

Noale, Marianna; Maggi, Stefania; Artibani, Walter; Bassi, Pier Francesco; Bertoni, Filippo; Bracarda, Sergio; Conti, Giario Natale; Corvò, Renzo; Gacci, Mauro; Graziotti, Pierpaolo; Magrini, Stefano Maria; Maurizi Enrici, Riccardo; Mirone, Vincenzo; Montironi, Rodolfo; Muto, Giovanni; Pecoraro, Stefano; Porreca, Angelo; Ricardi, Umberto; Tubaro, Andrea; Zagonel, Vittorina; Zattoni, Filiberto; Crepaldi, Gaetano

2017-04-01

The Pros-IT CNR project aims to monitor a sample of Italian males ≥18 years of age who have been diagnosed in the participating centers with incident prostate cancer, by analyzing their clinical features, treatment protocols and outcome results in relation to quality of life. Pros-IT CNR is an observational, prospective, multicenter study. The National Research Council (CNR), Neuroscience Institute, Aging Branch (Padua) is the promoting center. Ninety-seven Italian centers located throughout Italy were involved. The field study began in September 1, 2014. Subjects eligible were diagnosed with biopsy-verified prostate cancer, naïve. A sample size of 1500 patients was contemplated. A baseline assessment including anamnestic data, clinical history, risk factors, the initial diagnosis, cancer staging information and quality of life (Italian UCLA Prostate Cancer Index; SF-12 Scale) was completed. Six months after the initial diagnosis, a second assessment evaluating the patient's health status, the treatment carried out, and the quality of life will be made. A third assessment, evaluating the treatment follow-up and the quality of life, will be made 12 months after the initial diagnosis. The 4th, 5th, 6th and 7th assessments, similar to the third, will be completed 24, 36, 48 and 60 months after the initial diagnosis, respectively, and will include also a Food Frequency Questionnaire and the Physical Activity Scale for the Elderly. The study will provide information on patients' quality of life and its variations over time in relation to the treatments received for the prostate cancer.

Integrated learning through student goal development.

PubMed

Price, Deborah; Tschannen, Dana; Caylor, Shandra

2013-09-01

New strategies are emerging to promote structure and increase learning in the clinical setting. Nursing faculty designed a mechanism by which integrative learning and situated coaching could occur more readily in the clinical setting. The Clinical Goals Initiative was implemented for sophomore-, junior-, and senior-level students in their clinical practicums. Students developed weekly goals reflecting three domains of professional nursing practice. Goals were shared with faculty and staff nurse mentors at the beginning of the clinical day to help guide students and mentors with planning for learning experiences. After 6 weeks, faculty and students were surveyed to evaluate project effectiveness. Faculty indicated that goal development facilitated clinical learning by providing more student engagement, direction, and focus. Students reported that goal development allowed them to optimize clinical learning opportunities and track their growth and progress. Faculty and students indicated the goals promoted student self-learning, autonomy, and student communication with nurse mentors and faculty. Copyright 2013, SLACK Incorporated.

MD-CTS: An integrated terminology reference of clinical and translational medicine.

PubMed

Ray, Will; Finamore, Joe; Rastegar-Mojarad, Majid; Kadolph, Chris; Ye, Zhan; Bohne, Jacquie; Xu, Yin; Burish, Dan; Sondelski, Joshua; Easker, Melissa; Finnegan, Brian; Bartkowiak, Barbara; Smith, Catherine Arnott; Tachinardi, Umberto; Mendonca, Eneida A; Weichelt, Bryan; Lin, Simon M

2016-01-01

New vocabularies are rapidly evolving in the literature relative to the practice of clinical medicine and translational research. To provide integrated access to new terms, we developed a mobile and desktop online reference-Marshfield Dictionary of Clinical and Translational Science (MD-CTS). It is the first public resource that comprehensively integrates Wiktionary (word definition), BioPortal (ontology), Wiki (image reference), and Medline abstract (word usage) information. MD-CTS is accessible at http://spellchecker.mfldclin.edu/. The website provides a broadened capacity for the wider clinical and translational science community to keep pace with newly emerging scientific vocabulary. An initial evaluation using 63 randomly selected biomedical words suggests that online references generally provided better coverage (73%-95%) than paper-based dictionaries (57-71%).

Patient safety trilogy: perspectives from clinical engineering.

PubMed

Gieras, Izabella; Sherman, Paul; Minsent, Dennis

2013-01-01

This article examines the role a clinical engineering or healthcare technology management (HTM) department can play in promoting patient safety from three different perspectives: a community hospital, a national government health system, and an academic medical center. After a general overview, Izabella Gieras from Huntington Hospital in Pasadena, CA, leads off by examining the growing role of human factors in healthcare technology, and describing how her facility uses clinical simulations in medical equipment evaluations. A section by Paul Sherman follows, examining patient safety initiatives from the perspective of the Veterans Health Administration with a focus on hazard alerts and recalls. Dennis Minsent from Oregon Health & Science University writes about patient safety from an academic healthcare perspective, and details how clinical engineers can engage in multidisciplinary safety opportunities.

Follicular neoplasms of the thyroid: importance of clinical and cytological correlation.

PubMed

Granados-García, Martín; Cortés-Flores, Ana Olivia; del Carmen González-Ramírez, Imelda; Cano-Valdez, Ana María; Flores-Hernández, Lorena; Aguilar-Ponce, José Luis

2010-01-01

Thyroid cancer presents as nodules. Thyroid nodules are frequent, but only 5-30% are malignant. Fine needle aspiration biopsy (FNAB) is useful for initial evaluation; nevertheless, malignancy is uncertain when follicular neoplasm is reported. Some factors can be associated with malignancy. Therefore, we analyzed our follicular neoplasms in order to identify those factors associated with a higher risk of malignancy. We analyzed the clinical files of consecutive patients with cytological diagnoses of follicular neoplasm. From 1,005 cases of thyroid nodules, 121 were follicular neoplasms according to cytology. Of these, 75 were surgically treated. Definitive report showed 45 benign (60%) and 30 malignant (40%) cases. Benign cases included 29 goiters, 11 follicular adenomas, and 5 cases of thyroiditis. Malignant cases were comprised of 12 papillary carcinomas, 4 follicular carcinomas, 3 papillary carcinomas-follicular variant, 1 lymphoma, 1 teratoma, 5 medullary carcinomas, 2 insular carcinomas, 1 anaplastic carcinoma and 1 metastatic breast carcinoma. Tumor size of benign lesions was 3.43 ± 2.04 cm, and 4.67 ± 2.78 (p = 0.049) for malignant lesions. Age was 46.95 ± 15.39 years for benign lesions and 48.67 ± 17.28 for malignant lesions (p = 0.66). Fifty percent of males showed malignancy vs. 37.7% of females (p < 0.005). Our results suggest that size and gender, but not age, are associated with cytological pattern. Ultrasonographic characteristics may be useful discriminating patients with a higher risk of malignancy. FNAB is a useful tool for initial evaluation of thyroid nodules, but clinical evaluation can enhance predictive value.

The Relative Importance of Family History, Gender, Mode of Onset, and Age at Onsetin Predicting Clinical Features of First-Episode Psychotic Disorders.

PubMed

Compton, Michael T; Berez, Chantal; Walker, Elaine F

Family history of psychosis, gender, mode of onset, and age at onset are considered prognostic factors important to clinicians evaluating first-episode psychosis; yet, clinicians have little guidance as to how these four factors differentially predict early-course substance abuse, symptomatology, and functioning. We conducted a "head-to-head comparison" of these four factors regarding their associations with key clinical features at initial hospitalization. We also assessed potential interactions between gender and family history with regard to age at onset of psychosis and symptom severity. Consecutively admitted first-episode patients (n=334) were evaluated in two studies that rigorously assessed a number of early-course variables. Associations among variables of interest were examined using Pearson correlations, χ 2 tests, Student's t-tests, and 2×2 factorial analyses of variance. Substance (nicotine, alcohol, and cannabis) abuse and positive symptom severity were predicted only by male gender. Negative symptom severity and global functioning impairments were predicted by earlier age at onset of psychosis. General psychopathology symptom severity was predicted by both mode of onset and age at onset. Interaction effects were not observed with regard to gender and family history in predicting age at onset or symptom severity. The four prognostic features have differential associations with substance abuse, domains of symptom severity, and global functioning. Gender and age at onset of psychosis appear to be more predictive of clinical features at the time of initial evaluation (and thus presumably longer term outcomes) than the presence of a family history of psychosis and a more gradual mode of onset.

C-reactive protein as a marker of melanoma progression.

PubMed

Fang, Shenying; Wang, Yuling; Sui, Dawen; Liu, Huey; Ross, Merrick I; Gershenwald, Jeffrey E; Cormier, Janice N; Royal, Richard E; Lucci, Anthony; Schacherer, Christopher W; Gardner, Julie M; Reveille, John D; Bassett, Roland L; Wang, Li-E; Wei, Qingyi; Amos, Christopher I; Lee, Jeffrey E

2015-04-20

To investigate the association between blood levels of C-reactive protein (CRP) in patients with melanoma and overall survival (OS), melanoma-specific survival (MSS), and disease-free survival. Two independent sets of plasma samples from a total of 1,144 patients with melanoma (587 initial and 557 confirmatory) were available for CRP determination. Kaplan-Meier method and Cox regression were used to evaluate the relationship between CRP and clinical outcome. Among 115 patients who underwent sequential blood draws, we evaluated the relationship between change in disease status and change in CRP using nonparametric tests. Elevated CRP level was associated with poorer OS and MSS in the initial, confirmatory, and combined data sets (combined data set: OS hazard ratio, 1.44 per unit increase of logarithmic CRP; 95% CI, 1.30 to 1.59; P < .001; MSS hazard ratio, 1.51 per unit increase of logarithmic CRP; 95% CI, 1.36 to 1.68; P < .001). These findings persisted after multivariable adjustment. As compared with CRP < 10 mg/L, CRP ≥ 10 mg/L conferred poorer OS in patients with any-stage, stage I/II, or stage III/IV disease and poorer disease-free survival in those with stage I/II disease. In patients who underwent sequential evaluation of CRP, an association was identified between an increase in CRP and melanoma disease progression. CRP is an independent prognostic marker in patients with melanoma. CRP measurement should be considered for incorporation into prospective studies of outcome in patients with melanoma and clinical trials of systemic therapies for those with melanoma. © 2015 by American Society of Clinical Oncology.

Prognostic value of intraventricular bleeding in spontaneous intraparenchymal cerebral hemorrhage of small volume: a prospective cohort study.

PubMed

Fortes Lima, Telmo Tiburcio; Prandini, Mirto Nelso; Gallo, Pasquale; Cavalheiro, Sérgio

2012-04-01

The literature is controversial on whether intraventricular bleeding has a negative impact on the prognosis of spontaneous intracerebral hemorrhage. Nevertheless, an association between intraventricular bleeding and spontaneous intracerebral hemorrhage volumes has been consistently reported. To evaluate the prognostic value of intraventricular bleeding in deep intraparenchymal hypertensive spontaneous hemorrhage with a bleeding volume <30 cm(3). Of the 320 patients initially evaluated, 33 met the inclusion criteria and were enrolled in this prospective study. The volume of intraparenchymal hemorrhage was calculated by brain computed tomography (CT) image analysis, and the volume of intraventricular bleeding was calculated by the LeRoux scale. Clinical data, including neurological complications, were collected daily during hospitalization. Neurological outcome was evaluated 30 days after the event by using the Glasgow outcome scale. Patients were assigned to 1 of 3 groups according to intraventricular bleeding: Control, no intraventricular bleeding; LR 1, intraventricular bleeding with LeRoux scale scores of 1 to 8; or LR 2, intraventricular bleeding with LeRoux scale scores >8. There were no significant differences among groups concerning age, mean blood pressure, and time from onset to brain CT scan. Patients with greater intraventricular bleeding presented lower initial Glasgow coma scale scores, increased ventricular index and width of temporal horns, increased number of clinical and neurological complications, and longer hospitalization. Furthermore, their relative risk for unfavorable clinical outcome was 1.9 (95% confidence interval 1.25-2.49). Intraventricular bleeding with a LeRoux scale score >8 appears to have a negative effect on deep spontaneous intraparenchymal cerebral hemorrhage of small volume.

Quality measures for nurse practitioner practice evaluation.

PubMed

Kleinpell, Ruth; Kapu, April N

2017-08-01

Evaluating the impact of nurse practitioner (NP) practice has become a priority area of focus for demonstrating outcomes. A number of quality measures are available to enable practice-specific evaluation of NP roles and initiatives. This article reviews sources of quality measures that can be used to facilitate quantifying the outcomes of NP practice as part of an overall evaluation agenda. National resources and published literature on NP quality measures were reviewed. Various resources and toolkits exist to assist NPs in identifying outcomes of practice using quality measures. The need to demonstrate outcomes of NP practice remains an ongoing priority area regardless of the clinical practice setting. A variety of sources of quality measures exist that can be used to showcase the effect of NP care. The use of quality measures can be effectively integrated into evaluation of NP role and NP-directed initiatives to demonstrate impact, and enhance the conduct of an NP outcomes assessment. The use of organizational, NP-specific, and national-related quality measures can help to showcase how NP care improves the quality, safety, and costs of health care. ©2017 American Association of Nurse Practitioners.

Clinical Evaluation of Indirect Particle-Filled Composite Resin CAD/CAM Partial Crowns after 24 Months.

PubMed

Zimmermann, Moritz; Koller, Christina; Reymus, Marcel; Mehl, Albert; Hickel, Reinhard

2017-04-19

Resin-based CAD/CAM compound materials might be promising for single-tooth restorations. Insufficient clinical data are available for this new material class. The purpose of this study was to describe initial clinical in vivo results for indirect particle-filled composite resin CAD/CAM restorations after 24 months. Indirect particle-filled composite resin restorations were fabricated with a CAD/CAM method (CEREC Bluecam intraoral scanner, CEREC MCXL milling unit) by calibrated dental students. Forty-two partial crown restorations were seated adhesively in 30 patients with caries lesions or insufficient restorations (baseline). Strict inclusion criteria were defined for the patient collective. Follow-up evaluation comprised 40 restorations after 12 months and 33 restorations after 24 months. Evaluation criteria were modified FDI criteria with grades (1) to (5). Rating with FDI criteria (5) was defined as clinical failure. Statistical analysis was performed with Wilcoxon-Test (p < 0.05). The success rate of indirect particle-filled composite resin CAD/CAM restorations after 12 months was 95.0% with two debondings observed. The cumulative success rate for indirect particle-filled composite resin CAD/CAM restorations after 24 months was 85.7% with two tooth fractures and one debonding. Statistically significant differences were found for baseline and 24-month follow-up evaluation for anatomic form and marginal adaptation criterion examined in respect to FDI criteria guidelines (Wilcoxon-Test, p < 0.05). This study demonstrates particle-filled composite resin CAD/CAM restorations having a clinical success rate of 85.7% after 24 months. Adhesive bonding procedures need to be ensured carefully. A longer clinical evaluation period is necessary to draw further conclusions. © 2017 by the American College of Prosthodontists.

[Pearson syndrome. Case report].

PubMed

Cammarata-Scalisi, Francisco; López-Gallardo, Ester; Emperador, Sonia; Ruiz-Pesini, Eduardo; Da Silva, Gloria; Camacho, Nolis; Montoya, Julio

2011-09-01

Among the etiologies of anemia in the infancy, the mitochondrial cytopathies are infrequent. Pearson syndrome is diagnosed principally during the initial stages of life and it is characterized by refractory sideroblastic anemia with vacuolization of marrow progenitor cells, exocrine pancreatic dysfunction and variable neurologic, hepatic, renal and endocrine failures. We report the case of a 14 month-old girl evaluated by a multicentric study, with clinic and molecular diagnosis of Pearson syndrome, with the 4,977-base pair common deletion of mitochondrial DNA. This entity has been associated to diverse phenotypes within the broad clinical spectrum of mitochondrial disease.

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

Evaluation of a TB infection control implementation initiative in out-patient HIV clinics in Zambia and Botswana.

PubMed

Emerson, C; Lipke, V; Kapata, N; Mwananyambe, N; Mwinga, A; Garekwe, M; Lanje, S; Moshe, Y; Pals, S L; Nakashima, A K; Miller, B

2016-07-01

Out-patient human immunodeficiency virus (HIV) care and treatment clinics in Zambia and Botswana, countries with a high burden of HIV and TB infection. To develop a tuberculosis infection control (TB IC) training and implementation package and evaluate the implementation of TB IC activities in facilities implementing the package. Prospective program evaluation of a TB IC training and implementation package using a standardized facility risk assessment tool, qualitative interviews with facility health care workers and measures of pre- and post-test performance. A composite measure of facility performance in TB IC improved from 32% at baseline to 50% at 1 year among eight facilities in Zambia, and from 27% to 80% at 6 months among 10 facilities in Botswana. Although there was marked improvement in indicators of managerial, administrative and environmental controls, key ongoing challenges remained in ensuring access to personal protective equipment and implementing TB screening in health care workers. TB IC activities at out-patient HIV clinics in Zambia and Botswana improved after training using the implementation package. Continued infrastructure support, as well as monitoring and evaluation, are needed to support the scale-up and sustainability of TB IC programs in facilities in low-resource countries.

Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes

PubMed Central

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

Objective 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. Research design and methods 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. Results 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. Conclusions Saxagliptin initiation was not associated with increased risk of MACE, infection, AKI, ALF, or severe hypersensitivity reactions in clinical practice settings. Trial registration number NCT01086280, NCT01086293, NCT01086319, NCT01086306, and NCT01377935; Results. PMID:28878934

Exploring methods for comparing the real-world effectiveness of treatments for osteoporosis: adjusted direct comparisons versus using patients as their own control.

PubMed

Karlsson, Linda; Mesterton, Johan; Tepie, Maurille Feudjo; Intorcia, Michele; Overbeek, Jetty; Ström, Oskar

2017-09-21

Using Swedish and Dutch registry data for women initiating bisphosphonates, we evaluated two methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for differences in patient baseline characteristics. Each method has advantages and disadvantages; both are potential complements to clinical trial analyses. We evaluated methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for both observed and unobserved confounding. Swedish and Dutch registry data for women initiating zoledronate or oral bisphosphonates (OBPs; alendronate/risedronate) were used; the primary outcome was fracture. In adjusted direct comparisons (ADCs), regression and matching techniques were used to account for baseline differences in known risk factors for fracture (e.g., age, previous fracture, comorbidities). In an own-control analysis (OCA), for each treatment, fracture incidence in the first 90 days following treatment initiation (the baseline risk period) was compared with fracture incidence in the 1-year period starting 91 days after treatment initiation (the treatment exposure period). In total, 1196 and 149 women initiating zoledronate and 14,764 and 25,058 initiating OBPs were eligible in the Swedish and Dutch registries, respectively. Owing to the small Dutch zoledronate sample, only the Swedish data were used to compare fracture incidences between treatment groups. ADCs showed a numerically higher fracture incidence in the zoledronate than in the OBPs group (hazard ratio 1.09-1.21; not statistically significant, p > 0.05). For both treatment groups, OCA showed a higher fracture incidence in the baseline risk period than in the treatment exposure period, indicating a treatment effect. OCA showed a similar or greater effect in the zoledronate group compared with the OBPs group. ADC and OCA each possesses advantages and disadvantages. Combining both methods may provide an estimate of real-world treatment efficacy that could potentially complement clinical trial findings.

Study design for the "effect of METOprolol in CARDioproteCtioN during an acute myocardial InfarCtion" (METOCARD-CNIC): a randomized, controlled parallel-group, observer-blinded clinical trial of early pre-reperfusion metoprolol administration in ST-segment elevation myocardial infarction.

PubMed

Ibanez, Borja; Fuster, Valentin; Macaya, Carlos; Sánchez-Brunete, Vicente; Pizarro, Gonzalo; López-Romero, Pedro; Mateos, Alonso; Jiménez-Borreguero, Jesús; Fernández-Ortiz, Antonio; Sanz, Ginés; Fernández-Friera, Leticia; Corral, Ervigio; Barreiro, Maria-Victoria; Ruiz-Mateos, Borja; Goicolea, Javier; Hernández-Antolín, Rosana; Acebal, Carlos; García-Rubira, Juan Carlos; Albarrán, Agustín; Zamorano, José Luis; Casado, Isabel; Valenciano, Juan; Fernández-Vázquez, Felipe; de la Torre, José María; Pérez de Prado, Armando; Iglesias-Vázquez, José Antonio; Martínez-Tenorio, Pedro; Iñiguez, Andrés

2012-10-01

Infarct size predicts post-infarction mortality. Oral β-blockade within 24 hours of a ST-segment elevation acute myocardial infarction (STEMI) is a class-IA indication, however early intravenous (IV) β-blockers initiation is not encouraged. In recent magnetic resonance imaging (MRI)-based experimental studies, the β(1)-blocker metoprolol has been shown to reduce infarct size only when administered before coronary reperfusion. To date, there is not a single trial comparing the pre- vs. post-reperfusion β-blocker initiation in STEMI. The METOCARD-CNIC trial is testing whether the early initiation of IV metoprolol before primary percutaneous coronary intervention (pPCI) could reduce infarct size and improve outcomes when compared to oral post-pPCI metoprolol initiation. The METOCARD-CNIC trial is a randomized parallel-group single-blind (to outcome evaluators) clinical effectiveness trial conducted in 5 Counties across Spain that will enroll 220 participants. Eligible are 18- to 80-year-old patients with anterior STEMI revascularized by pPCI ≤6 hours from symptom onset. Exclusion criteria are Killip-class ≥III, atrioventricular block or active treatment with β-blockers/bronchodilators. Primary end point is infarct size evaluated by MRI 5 to 7 days post-STEMI. Prespecified major secondary end points are salvage-index, left ventricular ejection fraction recovery (day 5-7 to 6 months), the composite of (death/malignant ventricular arrhythmias/reinfarction/admission due to heart failure), and myocardial perfusion. The METOCARD-CNIC trial is testing the hypothesis that the early initiation of IV metoprolol pre-reperfusion reduces infarct size in comparison to initiation of oral metoprolol post-reperfusion. Given the implications of infarct size reduction in STEMI, if positive, this trial might evidence that a refined use of an approved inexpensive drug can improve outcomes of patients with STEMI. Copyright © 2012 Mosby, Inc. All rights reserved.

Diagnosis of systemic lupus erythematosus in an unusual presentation: what a primary care physician should know.

PubMed

Pramanik, Bimalendu

2014-01-01

Systemic Lupus Erythematosus (SLE) is a multisystem autoimmune disease affecting millions of people worldwide. It can affect any organ systems of the body. However, all systems may not be involved initially rather than they may be affected gradually, sometimes over years. Diagnosis depends on characteristic clinical features and laboratory test results. Some features such as skin rash, joint symptoms and oral ulcers are common in SLE. But initial presentation of many patients is unusual because either they do not have these common features of the disease or the presentation mimics other illnesses. As a result, delayed diagnosis and misdiagnosis are common. Therefore, high index of initial suspicion of SLE is critical. In clinical practice, SLE should be suspected in any patient presenting with an unexplained disease process involving two or more organ systems. To make a diagnosis in an unusual presentation, thorough clinical evaluation with details history of both present and past illnesses as well as laboratory tests for SLE should be performed. Usually primary-care physicians first evaluate SLE patients; but there is no single article, where all the information on when to suspect SLE in an unusual presentation, is available in an integrated form. In this article, a list of conditions, when SLE should be suspected in an unusual presentation, has been given and some relatively common areas with diagnostic challenges of SLE have been briefly described. To prepare this manuscript, most articles have been identified through 'Pubmed' search using keywords-atypical/ unusual presentation of SLE, case reports on SLE, gastrointestinal manifestations of SLE, neuropsychiatric SLE, diagnostic challenges with SLE, etc. Selected most articles are from currently medline-indexed journals.

Circulating cathelicidin levels correlate with mucosal disease activity in ulcerative colitis, risk of intestinal stricture in Crohn's disease, and clinical prognosis in inflammatory bowel disease.

PubMed

Tran, Diana Hoang-Ngoc; Wang, Jiani; Ha, Christina; Ho, Wendy; Mattai, S Anjani; Oikonomopoulos, Angelos; Weiss, Guy; Lacey, Precious; Cheng, Michelle; Shieh, Christine; Mussatto, Caroline C; Ho, Samantha; Hommes, Daniel; Koon, Hon Wai

2017-05-12

Cathelicidin (LL-37) is an antimicrobial peptide known to be associated with various autoimmune diseases. We attempt to determine if cathelicidin can accurately reflect IBD disease activity. We hypothesize that serum cathelicidin correlates with mucosal disease activity, stricture, and clinical prognosis of IBD patients. Serum samples were collected from two separate cohorts of patients at the University of California, Los Angeles. Cohort 1 consisted of 50 control, 23 UC, and 28 CD patients. Cohort 2 consisted of 20 control, 57 UC, and 67 CD patients. LL-37 levels were determined by ELISA. Data from both cohorts were combined for calculation of accuracies in indicating mucosal disease activity, relative risks of stricture, and odds ratios of predicting disease development. Serum cathelicidin levels were inversely correlated with Partial Mayo Scores of UC patients and Harvey-Bradshaw Indices of CD patients. Among IBD patients with moderate or severe initial disease activity, the patients with high initial LL-37 levels had significantly better recovery than the patients with low initial LL-37 levels after 6-18 months, suggesting that high LL-37 levels correlate with good prognosis. Co-evaluation of LL-37 and CRP levels was more accurate than CRP alone or LL-37 alone in the correlation with Mayo Endoscopic Score of UC patients. Low LL-37 levels indicated a significantly elevated risk of intestinal stricture in CD patients. Co-evaluation of LL-37 and CRP can indicate mucosal disease activity in UC patients. LL-37 can predict future clinical activity in IBD patients and indicate risk of intestinal stricture in CD patients.

Factors contributing to initial weight loss among adolescents with polycystic ovary syndrome.

PubMed

Geier, L M; Bekx, M T; Connor, E L

2012-12-01

To evaluate the impact of a multidisciplinary clinic on weight management among adolescents with PCOS. 140 adolescent females were evaluated in a multidisciplinary PCOS clinic from March 2005 to December 2008. The team included a pediatric endocrinologist, health psychologist, dietitian, and pediatric gynecologist. 110 were diagnosed with PCOS based on the Rotterdam Criteria. Height, weight, BMI, number of subspecialists seen, use of metformin, and compliance with return visits were obtained from medical records. American Family Children's Hospital in Madison, Wisconsin. 110 adolescent females with polycystic ovary syndrome. Consultation with a dietitian and health psychologist. Change in weight. The average age at first visit was 15.9 years. The average BMI was 34.7 kg/m(2) (range 18.1-55.5). Seventy-six percent had an initial BMI above the 95(th) percentile. Interactions with providers at the initial visit included a pediatric endocrinologist (100%), health psychologist (60.9%), dietitian (75.5%) and gynecologist (70.9%). Seventy one percent returned for a follow-up visit, (average time of 4.5 months between visits) with 57% achieving weight loss (average 3.5 kg) and an additional 12.6% demonstrating no significant weight gain (< 1.5 kg). Thus, 69.6% demonstrated weight loss/stabilization. In this multidisciplinary clinic for adolescents with PCOS, nearly 70% of patients succeeded in short-term weight stabilization, with 57% demonstrating weight loss. Interactions with the health psychologist and dietitian appeared to play a key role in successful weight control, supporting the importance of psychology and nutrition expertise in the management of this disorder. Copyright © 2012 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Does the number of veins ligated during varicococele surgery influence post-operative semen and hormone results?

PubMed

Majzoub, A; Elbardisi, H; Arafa, M; Agarwal, A; Al Said, S; Al Rumaihi, K

2016-09-01

Varicocele is a well-established cause of male subfertility, which is directly proportional to its clinical grade. Although newer ultrasonic grading systems have taken into account the existence of pampiniform venous plexi, little is known about the clinical significance of the number of veins ligated during surgery. Very few undersized studies reported an influence which triggered the need to evaluate such association. This is a retrospective study of 378 patients who underwent left microsurgical subinguinal varicocoelectomy. Semen analyses and blood hormone studies performed pre-operatively were compared to those executed 6 months after surgery. Patients were divided into abnormal semen and normal semen groups based on their initial semen results. They were also subdivided according to the number of veins ligated intraoperatively into three groups: <5, 5-10, and >10 veins. Sperm count, total motility, and progressive motility were significantly increased in 62, 60.3, and 53.3% of patients post-operatively (p = 0.001), respectively. No significant differences in hormone levels were detected overall. Of the 378 patients, 332 had an abnormal semen analysis, while the remaining 46 patients had a normal result. Sperm count, total motility, and progressive motility significantly increased after varicocoelectomy in patients with an abnormal initial semen analysis (p = 0.001). In 48.7% of patients, 5-10 veins were ligated during surgery, whereas 28.3% had >10 and 23% had <5 ligated veins. No statistically significant differences were noted in the initial or the follow-up results among the number of vein subgroups. Varicocele ligation improves patients' fertility potential. This improvement, however, is not influenced by the number of veins ligated intraoperatively. Clinical grading maintains its superiority in the evaluation of varicocele patients. © 2016 American Society of Andrology and European Academy of Andrology.

Radiologic Placement of Uncovered Stents for the Treatment of Malignant Colonic Obstruction Proximal to the Descending Colon

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

Yoon, Jehong; Kwon, Se Hwan, E-mail: Kwon98@khu.ac.kr; Lee, Chang-Kyun

PurposeTo evaluate the safety, feasibility, and patency rates of radiologic placement of uncovered stents for the treatment of malignant colonic obstruction proximal to the descending colon.Materials and MethodsThis was a retrospective, single-center study. From May 2003 to March 2015, 53 image-guided placements of uncovered stents (44 initial placements, 9 secondary placements) were attempted in 44 patients (male:female = 23:21; mean age, 71.8 years). The technical and clinical success, complication rates, and patency rates of the stents were also evaluated. Technical success was defined as the successful deployment of the stent under fluoroscopic guidance alone and clinical success was defined as the relief of obstructivemore » symptoms or signs within 48 h of stent deployment.ResultsIn total, 12 (27.3 %) patients underwent preoperative decompression, while 32 (72.7 %) underwent decompression with palliative intent. The technical success rate was 93.2 % (41/44) for initial placement and 88.9 % (8/9) for secondary placement. Secondary stent placement in the palliative group was required in nine patients after successful initial stent placement due to stent obstruction from tumor ingrowth (n = 7) and stent migration (n = 2). The symptoms of obstruction were relieved in all successful cases (100 %). In the palliative group, the patency rates were 94.4 % at 1 month, 84.0 % at 3 months, 64.8 % at 6 months, and 48.6 % at 12 months.ConclusionsThe radiologic placement of uncovered stents for the treatment of malignant obstruction proximal to the descending colon is feasible and safe, and provides acceptable clinical results.« less

Increased suicide risk and clinical correlates of suicide among patients with Parkinson's disease.

PubMed

Lee, Taeyeop; Lee, Hochang Benjamin; Ahn, Myung Hee; Kim, Juyeon; Kim, Mi Sun; Chung, Sun Ju; Hong, Jin Pyo

2016-11-01

Parkinson's disease (PD) is a debilitating, neurodegenerative condition frequently complicated by psychiatric symptoms. Patients with PD may be at higher risk for suicide than the general population, but previous estimates are limited and conflicting. The aim of this study is to estimate the suicide rate based on the clinical case registry and to identify risk factors for suicide among patients diagnosed with PD. The target sample consisted of 4362 patients diagnosed with PD who were evaluated at a general hospital in Seoul, South Korea, from 1996 to 2012. The standardized mortality ratio for suicide among PD patients was estimated. In order to identify the clinical correlates of suicide, case-control study was conducted based on retrospective chart review. The 29 suicide cases (age: 62.3 ± 13.7 years; females: 34.5%) were matched with 116 non-suicide controls (age: 63.5 ± 9.2 years; females 56.9%) by the year of initial PD evaluation. The SMR for suicide in PD patients was 1.99 (95% CI 1.33-2.85). Mean duration from time of initial diagnosis to suicide among cases was 6.1 ± 3.5 years. Case-control analysis revealed that male, initial extremity of motor symptom onset, history of depressive disorder, delusion, any psychiatric disorder, and higher L-dopa dosage were significantly associated with suicide among PD patients. Other PD-related variables such as UPDRS motor score were not significantly associated with death by suicide. Suicide risk in PD patients is approximately 2 times higher than that in the general population. Psychiatric disorders, and also L-dopa medication need further attention with respect to suicide. Copyright © 2016 Elsevier Ltd. All rights reserved.

Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases, a study protocol of the randomised phase 3 CAIRO5 study of the Dutch Colorectal Cancer Group (DCCG).

PubMed

Huiskens, Joost; van Gulik, Thomas M; van Lienden, Krijn P; Engelbrecht, Marc R W; Meijer, Gerrit A; van Grieken, Nicole C T; Schriek, Jonne; Keijser, Astrid; Mol, Linda; Molenaar, I Quintus; Verhoef, Cornelis; de Jong, Koert P; Dejong, Kees H C; Kazemier, Geert; Ruers, Theo M; de Wilt, Johanus H W; van Tinteren, Harm; Punt, Cornelis J A

2015-05-06

Colorectal cancer patients with unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and the lack of consensus on criteria for (un)resectability complicates the interpretation of published results. CAIRO5 is a multicentre, randomised, phase 3 clinical study. Colorectal cancer patients with initially unresectable liver-only metastases are eligible, and will not be selected for potential resectability. The (un)resectability status is prospectively assessed by a central panel consisting of at least one radiologist and three liver surgeons, according to predefined criteria. Tumours of included patients will be tested for RAS mutation status. Patients with RAS wild type tumours will be treated with doublet chemotherapy (FOLFOX or FOLFIRI) and randomised between the addition of either bevacizumab or panitumumab, and patients with RAS mutant tumours will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab or triple chemotherapy (FOLFOXIRI) plus bevacizumab. Radiological evaluation to assess conversion to resectability will be performed by the central panel, at an interval of two months. The primary study endpoint is median progression-free survival. Secondary endpoints are the R0/1 resection rate, median overall survival, response rate, toxicity, pathological response of resected lesions, postoperative morbidity, and correlation of baseline and follow-up evaluation with respect to outcomes by the central panel. CAIRO5 is a prospective multicentre trial that investigates the optimal systemic induction therapy for patients with initially unresectable, liver-only colorectal cancer metastases. CAIRO 5 is registered at European Clinical Trials Database (EudraCT) (2013-005435-24). CAIRO 5 is registered at ClinicalTrials.gov: NCT02162563 , June 10, 2014.

Evaluation of the BT-1 serum assay for breast cancer.

PubMed

Whitehurst, M M; Aldenderfer, P H; Sooy, M M; Strelkauskas, A J

1999-01-01

The BT-1 assay which identifies a novel breast tumor associated serum analyte was performed for 143 patients previously diagnosed with breast cancer. Mucin tumor markers CA15-3/CA27-29 values were available for 50 patients and there was very minor overlap between patients positive by both tests. Patients' follow-up clinical status at sample draw was compared to BT-1 assay results. 27% of patients originally diagnosed as Stage II and 20% patients originally diagnosed as Stage III who were evaluated 'no disease' had positive BT-1 values. 8% patients diagnosed as Stage II had negative BT-1 results in samples drawn within 90 days of chemotherapy initiation, whereas 23% of patients diagnosed as Stage III cancer were BT-1 test positive within 90 days of chemotherapy initiation. 50% of patients tested before initial breast cancer surgery had positive BT-1 values, suggesting that the BT-1 assay may be useful in identification women with more advanced disease at diagnosis.

Twin robotic x-ray system for 2D radiographic and 3D cone-beam CT imaging

NASA Astrophysics Data System (ADS)

Fieselmann, Andreas; Steinbrener, Jan; Jerebko, Anna K.; Voigt, Johannes M.; Scholz, Rosemarie; Ritschl, Ludwig; Mertelmeier, Thomas

2016-03-01

In this work, we provide an initial characterization of a novel twin robotic X-ray system. This system is equipped with two motor-driven telescopic arms carrying X-ray tube and flat-panel detector, respectively. 2D radiographs and fluoroscopic image sequences can be obtained from different viewing angles. Projection data for 3D cone-beam CT reconstruction can be acquired during simultaneous movement of the arms along dedicated scanning trajectories. We provide an initial evaluation of the 3D image quality based on phantom scans and clinical images. Furthermore, initial evaluation of patient dose is conducted. The results show that the system delivers high image quality for a range of medical applications. In particular, high spatial resolution enables adequate visualization of bone structures. This system allows 3D X-ray scanning of patients in standing and weight-bearing position. It could enable new 2D/3D imaging workflows in musculoskeletal imaging and improve diagnosis of musculoskeletal disorders.

The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.

PubMed

Trounson, Alan; DeWitt, Natalie D; Feigal, Ellen G

2012-01-01

Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies. The model proposed for Alpha Stem Cell Clinics will initially use the capacities and infrastructure that exist in the most advanced tertiary medical clinics for delivery of established bone marrow stem cell therapies. As the research evolves, they will incorporate improved procedures and cell preparations. This model enables commercialization of medical devices, reagents, and other products required for cell therapies. A carefully constructed cell therapy clinical infrastructure with the requisite scientific, technical, and medical expertise and operational efficiencies will have the capabilities to address three fundamental and critical functions: 1) fostering clinical trials; 2) evaluating and establishing safe and effective therapies, and 3) developing and maintaining the delivery of therapies approved by the Food and Drug Administration, or other regulatory agencies.

Office-based treatment and outcomes for febrile infants with clinically diagnosed bronchiolitis.

PubMed

Luginbuhl, Lynn M; Newman, Thomas B; Pantell, Robert H; Finch, Stacia A; Wasserman, Richard C

2008-11-01

The goals were to describe the (1) frequency of sepsis evaluation and empiric antibiotic treatment, (2) clinical predictors of management, and (3) serious bacterial illness frequency for febrile infants with clinically diagnosed bronchiolitis seen in office settings. The Pediatric Research in Office Settings network conducted a prospective cohort study of 3066 febrile infants (<3 months of age with temperatures >or=38 degrees C) in 219 practices in 44 states. We compared the frequency of sepsis evaluation, parenteral antibiotic treatment, and serious bacterial illness in infants with and without clinically diagnosed bronchiolitis. We identified predictors of sepsis evaluation and parenteral antibiotic treatment in infants with bronchiolitis by using logistic regression models. Practitioners were less likely to perform a complete sepsis evaluation, urine testing, and cerebrospinal fluid culture and to administer parenteral antibiotic treatment for infants with bronchiolitis, compared with those without bronchiolitis. Significant predictors of sepsis evaluation in infants with bronchiolitis included younger age, higher maximal temperature, and respiratory syncytial virus testing. Predictors of parenteral antibiotic use included initial ill appearance, age of <30 days, higher maximal temperature, and general signs of infant distress. Among infants with bronchiolitis (N = 218), none had serious bacterial illness and those with respiratory distress signs were less likely to receive parenteral antibiotic treatment. Diagnoses among 2848 febrile infants without bronchiolitis included bacterial meningitis (n = 14), bacteremia (n = 49), and urinary tract infection (n = 167). In office settings, serious bacterial illness in young febrile infants with clinically diagnosed bronchiolitis is uncommon. Limited testing for bacterial infections seems to be an appropriate management strategy.

Evaluations of refraction competencies of ophthalmic technicians in Mozambique.

PubMed

Shah, Kajal; Naidoo, Kovin; Chagunda, Margarida; Loughman, James

2016-01-01

Ophthalmic technicians (OT) work at health facilities in Mozambique and are trained to provide primary and secondary eye care services including basic refraction. This study was designed to assess OT competence and confidence in refraction, and investigate whether an upskilling programme is effective in developing their competence and confidence at refraction. Thirty-one trainee OTs and 16 qualified OTs were recruited to the study. A background questionnaire was administered to determine the demographic profile of the OTs. A confidence levels questionnaire explored their self-reported skills. Clinical competencies were assessed in relation to knowledge (theory exam) and clinical skills (patient exams). 11 OTs were upskilled and the clinical evaluations carried out post training. Initial evaluations demonstrated that confidence and competence levels varied depending on the OTs training (location and duration), and their location of work (clinical load, availability of equipment and other eye care personnel). The qualified OTs were more competent than trainee OTs in most of the evaluations. Post upskilling results demonstrated significant positive impact on confidence and competence levels. These evaluations identified factors affecting the refraction competencies of the OTs and demonstrated that upskilling is effective in improving confidence and competence levels for refraction. They demonstrate the need for a refraction competency framework. The overarching aim of this research was to inform the development of a nationwide programme of OT mentoring, upskilling and leading to the establishment of clinical competency standards for the new OT curricula, relevant to the professional demands. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

An Automatic Assessment System of Diabetic Foot Ulcers Based on Wound Area Determination, Color Segmentation, and Healing Score Evaluation.

PubMed

Wang, Lei; Pedersen, Peder C; Strong, Diane M; Tulu, Bengisu; Agu, Emmanuel; Ignotz, Ron; He, Qian

2015-08-07

For individuals with type 2 diabetes, foot ulcers represent a significant health issue. The aim of this study is to design and evaluate a wound assessment system to help wound clinics assess patients with foot ulcers in a way that complements their current visual examination and manual measurements of their foot ulcers. The physical components of the system consist of an image capture box, a smartphone for wound image capture and a laptop for analyzing the wound image. The wound image assessment algorithms calculate the overall wound area, color segmented wound areas, and a healing score, to provide a quantitative assessment of the wound healing status both for a single wound image and comparisons of subsequent images to an initial wound image. The system was evaluated by assessing foot ulcers for 12 patients in the Wound Clinic at University of Massachusetts Medical School. As performance measures, the Matthews correlation coefficient (MCC) value for the wound area determination algorithm tested on 32 foot ulcer images was .68. The clinical validity of our healing score algorithm relative to the experienced clinicians was measured by Krippendorff's alpha coefficient (KAC) and ranged from .42 to .81. Our system provides a promising real-time method for wound assessment based on image analysis. Clinical comparisons indicate that the optimized mean-shift-based algorithm is well suited for wound area determination. Clinical evaluation of our healing score algorithm shows its potential to provide clinicians with a quantitative method for evaluating wound healing status. © 2015 Diabetes Technology Society.

Integrated internist - addiction medicine - hepatology model for hepatitis C management for individuals on methadone maintenance.

PubMed

Martinez, A D; Dimova, R; Marks, K M; Beeder, A B; Zeremski, M; Kreek, M J; Talal, A H

2012-01-01

Despite a high prevalence of hepatitis C virus (HCV) among drug users, HCV evaluation and treatment acceptance are extremely low among these patients when referred from drug treatment facilities for HCV management. We sought to increase HCV treatment effectiveness among patients from a methadone maintenance treatment program (MMTP) by maintaining continuity of care. We developed, instituted and retrospectively assessed the effectiveness of an integrated, co-localized care model in which an internist-addiction medicine specialist from MMTP was embedded in the hepatitis clinic. Methadone maintenance treatment program patients were referred, evaluated by the internist and hepatologist in hepatitis clinic and provided HCV treatment with integration between both sites. Of 401 evaluated patients, anti-HCV antibody was detected in 257, 86% of whom were older than 40 years. Hepatitis C virus RNA levels were measured in 222 patients, 65 of whom were aviremic. Of 157 patients with detectable HCV RNA, 125 were eligible for referral to the hepatitis clinic, 76 (61%) of whom accepted and adhered with the referral. Men engaged in MMTP <36 months were significantly less likely to be seen in hepatitis clinic than men in MMTP more than 36 months (odds ratio = 7.7; 95% confidence interval 2.6-22.9) or women. We evaluated liver histology in 63 patients, and 83% had moderate to advanced liver disease. Twenty-four patients initiated treatment with 19 completing and 13 (54%) achieving sustained response. In conclusion, integrated care between the MMTP and the hepatitis clinic improves adherence with HCV evaluation and treatment compared to standard referral practices. © 2010 Blackwell Publishing Ltd.

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.

Development of clinical process measures for pediatric burn care: Understanding variation in practice patterns.

PubMed

Kazis, Lewis E; Sheridan, Robert L; Shapiro, Gabriel D; Lee, Austin F; Liang, Matthew H; Ryan, Colleen M; Schneider, Jeffrey C; Lydon, Martha; Soley-Bori, Marina; Sonis, Lily A; Dore, Emily C; Palmieri, Tina; Herndon, David; Meyer, Walter; Warner, Petra; Kagan, Richard; Stoddard, Frederick J; Murphy, Michael; Tompkins, Ronald G

2018-04-01

There has been little systematic examination of variation in pediatric burn care clinical practices and its effect on outcomes. As a first step, current clinical care processes need to be operationally defined. The highly specialized burn care units of the Shriners Hospitals for Children system present an opportunity to describe the processes of care. The aim of this study was to develop a set of process-based measures for pediatric burn care and examine adherence to them by providers in a cohort of pediatric burn patients. We conducted a systematic literature review to compile a set of process-based indicators. These measures were refined by an expert panel of burn care providers, yielding 36 process-based indicators in four clinical areas: initial evaluation and resuscitation, acute excisional surgery and critical care, psychosocial and pain control, and reconstruction and aftercare. We assessed variability in adherence to the indicators in a cohort of 1,076 children with burns at four regional pediatric burn programs in the Shriners Hospital system. The percentages of the cohort at each of the four sites were as follows: Boston, 20.8%; Cincinnati, 21.1%; Galveston, 36.0%; and Sacramento, 22.1%. The cohort included children who received care between 2006 and 2010. Adherence to the process indicators varied both across sites and by clinical area. Adherence was lowest for the clinical areas of acute excisional surgery and critical care, with a range of 35% to 48% across sites, followed by initial evaluation and resuscitation (range, 34%-60%). In contrast, the clinical areas of psychosocial and pain control and reconstruction and aftercare had relatively high adherence across sites, with ranges of 62% to 93% and 71% to 87%, respectively. Of the 36 process indicators, 89% differed significantly in adherence between clinical sites (p < 0.05). Acute excisional surgery and critical care exhibited the most variability. The development of this set of process-based measures represents an important step in the assessment of clinical practice in pediatric burn care. Substantial variation was observed in practices of pediatric burn care. However, further research is needed to link these process-based measures to clinical outcomes. Therapeutic/care management, level IV.

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

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.

The early effects of Medicare's mandatory hospital pay-for-performance program.

PubMed

Ryan, Andrew M; Burgess, James F; Pesko, Michael F; Borden, William B; Dimick, Justin B

2015-02-01

To evaluate the impact of hospital value-based purchasing (HVBP) on clinical quality and patient experience during its initial implementation period (July 2011-March 2012). Hospital-level clinical quality and patient experience data from Hospital Compare from up to 5 years before and three quarters after HVBP was initiated. Acute care hospitals were exposed to HVBP by mandate while critical access hospitals and hospitals located in Maryland were not exposed. We performed a difference-in-differences analysis, comparing performance on 12 incentivized clinical process and 8 incentivized patient experience measures between hospitals exposed to the program and a matched comparison group of nonexposed hospitals. We also evaluated whether hospitals that were ultimately exposed to HVBP may have anticipated the program by improving quality in advance of its introduction. Difference-in-differences estimates indicated that hospitals that were exposed to HVBP did not show greater improvement for either the clinical process or patient experience measures during the program's first implementation period. Estimates from our preferred specification showed that HVBP was associated with a 0.51 percentage point reduction in composite quality for the clinical process measures (p > .10, 95 percent CI: -1.37, 0.34) and a 0.30 percentage point reduction in composite quality for the patient experience measures (p > .10, 95 percent CI: -0.79, 0.19). We found some evidence that hospitals improved performance on clinical process measures prior to the start of HVBP, but no evidence of this phenomenon for the patient experience measures. The timing of the financial incentives in HVBP was not associated with improved quality of care. It is unclear whether improvement for the clinical process measures prior to the start of HVBP was driven by the expectation of the program or was the result of other factors. © Health Research and Educational Trust.

Initial evaluation of the training programme for health care professionals on the use of Malaysian clinical practice guidelines for management of dementia.

PubMed

Yusoff, S; Koh, C T; Mohd Aminuddin, M Y; Krishnasamy, M; Suhaila, M Z

2013-09-01

The Malaysian Clinical Practice Guidelines (CPG) for Management of Dementia (second edition) was launched in April 2010 by the Ministry of Health Malaysia. A training programme for the management of dementia, involving all categories of staff working at primary and secondary centres, was implemented to ensure that care delivery for people with dementia was in accordance with the guidelines. The study aimed to look into improving knowledge and understanding of dementia following training, and to evaluate the effectiveness of the training programme using a clinical audit indicator recommended in the guidelines. The study entailed 2 phases (at national and state levels). The first phase involved the CPG training programme run as a 1.5-day workshop, in which participants filled up pre- and post-workshop questionnaires. A second phase involved analysing all the referral letters to the memory clinic at the Hospital Sultan Ismail, Johor Bahru 1 year before and after the training programme. There was a significant improvement in knowledge about dementia and its management among the health care professionals following training. The mean percentage score for the pre-workshop test was 63% while for the post-workshop test it was 78%, giving a difference of 15%. Although there was an overall improvement in knowledge gain following training in both specialist and non-specialist groups, these differences were not statistically significant (t = 1.32; 95% confidence interval, -2.61 to 9.61; p = 0.25). The proportion of referrals with a possible diagnosis of dementia from primary clinic referrals to the memory clinic also increased from 18% to 44% after training. There was an overall improvement in the knowledge about dementia among the health care professionals following the training, which was reflected in the increase in referrals to the memory clinic. Although the initial results appeared to be promising, a multicentre study is warranted to conclude that the training had been effective.

Factors associated with the decision of the rheumatologist to order sacroiliac joints magnetic resonance imaging (SI-MRI) or HLA-B27 testing in the diagnostic work-up of patients with spondyloarthritis in clinical practice.

PubMed

Bautista-Molano, Wilson; Landewé, Robert B M; Serna, Cesar; Valle-Oñate, Rafael; van der Heijde, Désirée

2017-01-01

To evaluate the patients' characteristics associated with the clinical decision to request SI-MRI and/or HLA-B27 in patients with SpA in daily practice. Patients referred to a rheumatology outpatient-clinic in a national referral-centre were selected. Patients with a clinical diagnosis of SpA according to the rheumatologist were included. SI-MRI and HLA-B27 was available for patients in whom the rheumatologists had ordered these tests. Characteristics associated with ordering SI-MRI or HLA-B27 were identified with univariable analyses. Variables with p-value <0.05 and >80% completeness were selected for further analysis. A multivariable logistic regression analysis was used to evaluate the determinants related with the decision to perform SI-MRI and/or HLA-B27 and odds ratios with 95% confidence intervals were calculated. In total, 581 patients with SpA were included in the cohort, 72% were men, mean age 34.6±12.1 and disease duration 7.3±9.7 years. Of these patients, 24% (n=137) had SI-MRI and 77% (n=441) had HLA-B27 tests ordered. Independently predictive factors for ordering a SI-MRI were the presence of IBP (OR=1.81), enthesitis (OR=1.57) and the number of initial-symptoms at presentation (OR=1.27 per additional symptom present). Independently predictive factors of HLA-B27 testing were the number of initial-symptoms (OR=1.45 per symptom) and uveitis (OR=3.19). This study strongly suggests that rheumatologists use certain clinical clues to decide if they order expensive and scarce tests in the diagnostic work-up of SpA patients. These manifestations may increase the efficiency of these tests in clinical practice and suggest that clinical reasoning follows principles of Bayesian theory.

Initial Clinical Experience Using the Low-Profile Altura Endograft System With Double D-Shaped Proximal Stents for Endovascular Aneurysm Repair.

PubMed

Krievins, Dainis; Krämer, Albrecht; Savlovskis, Janis; Oszkinis, Georgij; Debus, E Sebastian; Oberhuber, Alexander; Zarins, Christopher K

2018-06-01

To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double "D-shaped" stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal. From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, and blood loss ≥1000 mL), and clinical success (freedom from procedure-related death, type I/III endoleak, migration, thrombosis, and reintervention). Endografts were successfully implanted in 89 (99%) patients; the single failure was due to delivery system malfunction before insertion in the early-generation device. One (1%) patient died and 4 patients underwent reinterventions (1 type I endoleak, 2 iliac limb stenoses, and 1 endograft occlusion) within the first 30 days. During a median follow-up of 12.5 months (range 11.5-50.9), there were no aneurysm ruptures, surgical conversions, or AAA-related deaths. The cumulative MAE rates were 3% (3/89) at 6 months and 7% (6/89) at 1 year. Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively. Clinical success was 94% (84/89) at 30 days, 98% (85/87) at 6 months, and 99% (82/83) at 1 year. Early results suggest that properly selected AAA patients can be safely treated using the Altura Endograft System with favorable midterm outcome. Thus, further clinical investigation is warranted to evaluate the role of this device in the treatment of AAA.

Improving metabolic monitoring in patients maintained on antipsychotics in Penang, Malaysia.

PubMed

Hor, Esther Sl; Subramaniam, Sivasangari; Koay, Jun Min; Bharathy, Arokiamary; Vasudevan, Umadevi; Panickulam, Joseph J; Ng, InnTiong; Arif, Nor Hayati; Russell, Vincent

2016-02-01

To evaluate the monitoring of metabolic parameters among outpatients maintained on antipsychotic medications in a general hospital setting in Malaysia and to assess the impact of a local monitoring protocol. By performing a baseline audit of files from a random sample of 300 patients prescribed antipsychotic medications for at least 1 year; we determined the frequency of metabolic monitoring. The findings informed the design of a new local protocol, on which clinical staff was briefed. We re-evaluated metabolic monitoring immediately after implementation, in a small sample of new referrals and current patients. We explored staff perceptions of the initiative with a follow-up focus group, 6 months post-implementation. The baseline audit revealed a sub-optimal frequency of metabolic parameter recording. Re-audit, following implementation of the new protocol, revealed improved monitoring but persisting deficits. Dialogue with the clinical staff led to further protocol modification, clearer definition of staff roles and use of a standard recording template. Focus group findings revealed positive perceptions of the initiative, but persisting implementation barriers, including cultural issues surrounding waist circumference measurement. Responding to challenges in achieving improved routine metabolic monitoring of patients maintained on antipsychotics required on-going dialogue with the clinical staff, in order to address both service pressures and cultural concerns. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Planning, expectation, and image evaluation for PACS at the University of Iowa Hospitals and Clinics

NASA Astrophysics Data System (ADS)

Franken, E. A., Jr.; Smith, Wilbur L.; Berbaum, Kevin S.; Owen, David A.; Hilsenrath, Peter

1990-08-01

Our strategy in studying PACS is to evaluate its clinical implementation working with equipment supplied by an established manufacturer. Fiscal and personnel resources required to design and integrate the hardware components and operational software to develop a functional PACS precluded a bottom up development approach at our institution. Imaging equipment vendors possess more abundant design development resources for this task and therefore can support a more rapid development of the initial components of PACS. For this reason we have chosen to serve as a beta test site to study the viability of the basic PACS components in a clinical setting. Our efforts primarily focus on: (1) image quality; (2) cost effectiveness; (3) PACS/HIS/RIS integration; (4) equipment and software reliability; and (5) overall system performance. The results of our studies are shared with the vendor for future PACS development and refi nement. To attain our investigational goals we have formed an interdisciplinary team of Radiologists, Perceptual Psychologist, Economist, Electrical and Industrial Engineers, Hospital Information System personnel and key departmental administrative staff. For several reasons Pediatric Radiology was targeted as the initial area for our PACS study: a small area representative of the overall operation,tight operational controls and willingness of physicians. We used a step-wise approach, the first step being the installation of PACS exclusively within the physical confines of Pediatric Radiology.

Initial Image Quality and Clinical Experience with New CR Digital Mammography System: A Phantom and Clinical Study

NASA Astrophysics Data System (ADS)

Gaona, Enrique; Alfonso, Beatriz Y. Álvarez; Castellanos, Gustavo Casian; Enríquez, Jesús Gabriel Franco

2008-08-01

The goal of the study was to evaluate the first CR digital mammography system (® Konica-Minolta) in Mexico in clinical routine for cancer detection in a screening population and to determine if high resolution CR digital imaging is equivalent to state-of-the-art screen-film imaging. The mammograms were evaluated by two observers with cytological or histological confirmation for BIRADS 3, 4 and 5. Contrast, exposure and artifacts of the images were evaluated. Different details like skin, retromamillary space and parenchymal structures were judged. The detectability of microcalcifications and lesions were compared and correlated to histology. The difference in sensitivity of CR Mammography (CRM) and Screen Film Mammography (SFM) was not statistically significant. However, CRM had a significantly lower recall rate, and the lesion detection was equal or superior to conventional images. There is no significant difference in the number of microcalcifications and highly suspicious calcifications were equally detected on both film-screen and digital images. Different anatomical regions were better detectable in digital than in conventional mammography.

Delayed LGI1 seropositivity in voltage-gated potassium channel (VGKC)-complex antibody limbic encephalitis

PubMed Central

Sweeney, Michael; Galli, Jonathan; McNally, Scott; Tebo, Anne; Haven, Thomas; Thulin, Perla; Clardy, Stacey L

2017-01-01

We utilise a clinical case to highlight why exclusion of voltage-gated potassium channel (VGKC)-complex autoantibody testing in serological evaluation of patients may delay or miss the diagnosis. A 68-year-old man presented with increasing involuntary movements consistent with faciobrachial dystonic seizures (FBDS). Initial evaluation demonstrated VGKC antibody seropositivity with leucine-rich glioma-inactivated 1 (LGI1) and contactin-associated protein-like 2 (CASPR2) seronegativity. Aggressive immunotherapy with methylprednisolone and plasmapheresis was started early in the course of his presentation. Following treatment with immunotherapy, the patient demonstrated clinical improvement. Repeat serum evaluation 4 months posthospitalisation remained seropositive for VGKC-complex antibodies, with development of LGI1 autoantibody seropositivity. VGKC-complex and LGI1 antibodies remained positive 12 months posthospitalisation. Our findings suggest that clinical symptoms can predate the detection of the antibody. We conclude that when suspicion for autoimmune encephalitis is high in the setting of VGKC autoantibody positivity, regardless of LGI1 or CASPR2 seropositivity, early immunotherapy and repeat testing should be considered. PMID:28432047

Delayed LGI1 seropositivity in voltage-gated potassium channel (VGKC)-complex antibody limbic encephalitis.

PubMed

Sweeney, Michael; Galli, Jonathan; McNally, Scott; Tebo, Anne; Haven, Thomas; Thulin, Perla; Clardy, Stacey L

2017-04-20

We utilise a clinical case to highlight why exclusion of voltage-gated potassium channel (VGKC)-complex autoantibody testing in serological evaluation of patients may delay or miss the diagnosis. A 68-year-old man presented with increasing involuntary movements consistent with faciobrachial dystonic seizures (FBDS). Initial evaluation demonstrated VGKC antibody seropositivity with leucine-rich glioma-inactivated 1 (LGI1) and contactin-associated protein-like 2 (CASPR2) seronegativity. Aggressive immunotherapy with methylprednisolone and plasmapheresis was started early in the course of his presentation. Following treatment with immunotherapy, the patient demonstrated clinical improvement. Repeat serum evaluation 4 months posthospitalisation remained seropositive for VGKC-complex antibodies, with development of LGI1 autoantibody seropositivity. VGKC-complex and LGI1 antibodies remained positive 12 months posthospitalisation. Our findings suggest that clinical symptoms can predate the detection of the antibody. We conclude that when suspicion for autoimmune encephalitis is high in the setting of VGKC autoantibody positivity, regardless of LGI1 or CASPR2 seropositivity, early immunotherapy and repeat testing should be considered. 2017 BMJ Publishing Group Ltd.

Initial Image Quality and Clinical Experience with New CR Digital Mammography System: A Phantom and Clinical Study

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

Gaona, Enrique; Enriquez, Jesus Gabriel Franco; Alfonso, Beatriz Y. Alvarez

2008-08-11

The goal of the study was to evaluate the first CR digital mammography system ( registered Konica-Minolta) in Mexico in clinical routine for cancer detection in a screening population and to determine if high resolution CR digital imaging is equivalent to state-of-the-art screen-film imaging. The mammograms were evaluated by two observers with cytological or histological confirmation for BIRADS 3, 4 and 5. Contrast, exposure and artifacts of the images were evaluated. Different details like skin, retromamillary space and parenchymal structures were judged. The detectability of microcalcifications and lesions were compared and correlated to histology. The difference in sensitivity of CRmore » Mammography (CRM) and Screen Film Mammography (SFM) was not statistically significant. However, CRM had a significantly lower recall rate, and the lesion detection was equal or superior to conventional images. There is no significant difference in the number of microcalcifications and highly suspicious calcifications were equally detected on both film-screen and digital images. Different anatomical regions were better detectable in digital than in conventional mammography.« less

SMILE: Simple, Mental Health, Initiative in Learning and Education.

PubMed

Ward, L J

2011-12-01

SMILE is a Simple, Mental health, Initiative in Learning and Education. SMILE was a pilot project introduced into an undergraduate clinical nursing program, Southern Cross University, Australia 2010. The program aimed to improve the knowledge and skills of third-year nursing students participating in their first clinical placement in mental healthcare. Complementary to the clinical nursing program and the university curriculum, SMILE provided further training and support for student learning in mental healthcare. The SMILE project was a structured 15-day education program that covered the following topics: suicide prevention; psychosis; drugs and alcohol education; mental state exam; families and carers in mental health; and the Mental Health Act. The education sessions were one hour in duration. The educational material and resources were created from current research, literature and health service policy. A problem-based learning approach was used to support this education project. The dynamic factor related to SMILE was that it was based in the field. SMILE enabled the students to bridge a theory-practice gap and expand upon their current knowledge base as well as participate in ward activity. Twenty students attending their first clinical placement in mental healthcare participated in SMILE and were asked to complete a pre- and post- evaluation questionnaire before starting and upon completion of the 15-day project. The students participating in SMILE reported a greater understanding of mental healthcare issues and expressed a developing knowledge base and improved practical skill level. SMILE was a positive initiative that provided valuable feedback and opportunity to improve on clinical education in mental healthcare.

Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products.

PubMed

Lucas-Samuel, Sophie; Ferry, Nicolas; Trouvin, Jean-Hugues

2015-01-01

Advanced therapy medicinal products, a new class of products with promising therapeutic effects, have been classified as medicinal products and as such should be developed according to a well-structured development plan, to establish their quality, safety and efficacy profile and conclude, at the time of the marketing authorisation evaluation, on a positive risk/benefit balance for patients. An important part of this development plan is achieved through clinical trials, which have also to be approved according to a well-established regulatory process, prior any initiation. This chapter is dedicated to describe the regulatory pathway to be followed in France, before initiating any clinical trial with those investigational advanced therapy medicinal products. In France, to get the final authorisation to initiate a clinical trial, the legislation imposes to run in parallel two independent but complementary authorisation procedures. The first procedure is aimed at assessing the ethical aspect of the biomedical research, while the second has to review the safety and regulatory aspects. A third procedure has to be envisaged where in case the investigational product consists or contains a genetically modified organism. The French system herein described is in line with the EU regulation on clinical trial and follows the respective deadlines for granting the final approval. The complexity of the procedure is in fact more due to the complexity of the products and protocols to be assessed than to the procedure itself which is now very close to the well-known procedure applied routinely for more conventional chemical or biological candidate medicinal products.

Concussion Care Practices and Utilization of Evidence-Based Guidelines in the Evaluation and Management of Concussion: A Survey of New England Emergency Departments.

PubMed

Stern, Robert A; Seichepine, Daniel; Tschoe, Christine; Fritts, Nathan G; Alosco, Michael L; Berkowitz, Oren; Burke, Peter; Howland, Jonathan; Olshaker, Jonathan; Cantu, Robert C; Baugh, Christine M; Holsapple, James W

2017-02-15

Evidence-based clinical practice guidelines can facilitate proper evaluation and management of concussions in the emergency department (ED), often the initial and primary point of contact for concussion care. There is no universally adopted set of guidelines for concussion management, and extant evidence suggests that there may be variability in concussion care practices and limited application of clinical practice guidelines in the ED. This study surveyed EDs throughout New England to examine current practices of concussion care and utilization of evidence-based clinical practice guidelines in the evaluation and management of concussions. In 2013, a 32-item online survey was e-mailed to 149/168 EDs throughout New England (Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, Maine). Respondents included senior administrators asked to report on their EDs use of clinical practice guidelines, neuroimaging decision-making, and discharge instructions for concussion management. Of the 72/78 respondents included, 35% reported absence of clinical practice guidelines, and 57% reported inconsistency in the type of guidelines used. Practitioner preference guided neuroimaging decision-making for 57%. Although 94% provided written discharge instructions, there was inconsistency in the recommended time frame for follow-up care (13% provided no specific time frame), the referral specialist to be seen (25% did not recommend any specialist), and return to activity instructions were inconsistent. There is much variability in concussion care practices and application of evidence-based clinical practice guidelines in the evaluation and management of concussions in New England EDs. Knowledge translational efforts will be critical to improve concussion management in the ED setting.

Evaluation of a multimodal, distance learning HIV management course for clinical care providers in India.

PubMed

Chang, Larry William; Kadam, Dileep B; Sangle, Shashi; Narayanan, Shivakumar; Borse, Rohidas T; McKenzie-White, Jane; Bowen, Craig W; Sisson, Stephen D; Bollinger, Robert C

2012-01-01

Distance learning is an important tool for training HIV health workers. However, there is limited evidence on design and evaluation of distance learning HIV curricula and tools. We therefore designed, implemented, and evaluated a distance learning course on HIV management for clinical care providers in India. After course completion, participant scores rose significantly from a pretest (78.4% mean correct) compared with the posttest (87.5%, P < .001). After course completion, participants were more likely to be confident in starting an initial antiretroviral (ARV) regimen, understanding ARV toxicities, encouraging patient adherence, diagnosing immune reconstitution syndrome, and monitoring patients on ARV medications (P ≤ .05). All participants (100%) strongly agreed/agreed that they would recommend this course to others, and most of them (96%) strongly agreed/agreed that they would take a course in this format again. A pragmatic approach to HIV curriculum development and evaluation resulted in reliable learning outcomes, as well as learner satisfaction and improvement in knowledge.

Predicting persistence of functional abdominal pain from childhood into young adulthood.

PubMed

Horst, Sara; Shelby, Grace; Anderson, Julia; Acra, Sari; Polk, D Brent; Saville, Benjamin R; Garber, Judy; Walker, Lynn S

2014-12-01

Pediatric functional abdominal pain has been linked to functional gastrointestinal disorders (FGIDs) in adulthood, but little is known about patient characteristics in childhood that increase the risk for FGID in young adulthood. We investigated the contribution of gastrointestinal symptoms, extraintestinal somatic symptoms, and depressive symptoms in pediatric patients with functional abdominal pain and whether these predicted FGIDs later in life. In a longitudinal study, consecutive new pediatric patients, diagnosed with functional abdominal pain in a subspecialty clinic, completed a comprehensive baseline evaluation of the severity of their physical and emotional symptoms. They were contacted 5 to 15 years later and evaluated, based on Rome III symptom criteria, for abdominal pain-related FGIDs, including irritable bowel syndrome, functional dyspepsia, functional abdominal pain syndrome, and abdominal migraine. Controlling for age, sex, baseline severity of abdominal pain, and time to follow-up evaluation, multivariable logistic regression was used to evaluate the association of baseline gastrointestinal, extraintestinal somatic, and depressive symptoms in childhood with FGID in adolescence and young adulthood. Of 392 patients interviewed an average of 9.2 years after their initial evaluation, 41% (n = 162) met symptom criteria for FGID; most met the criteria for irritable bowel syndrome. Extraintestinal somatic and depressive symptoms at the initial pediatric evaluation were significant predictors of FGID later in life, after controlling for initial levels of GI symptoms. Age, sex, and abdominal pain severity at initial presentation were not significant predictors of FGID later in life. In pediatric patients with functional abdominal pain, assessment of extraintestinal and depressive symptoms may be useful in identifying those at risk for FGID in adolescence and young adulthood. Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.

Evaluation of the sustained implementation of a mental health learning initiative in long-term care.

PubMed

McAiney, Carrie A; Stolee, Paul; Hillier, Loretta M; Harris, Diane; Hamilton, Pam; Kessler, Linda; Madsen, Victoria; Le Clair, J Kenneth

2007-10-01

This paper describes an innovative education program for the management of mental health problems in long-term care (LTC) homes and the evaluation of its longer-term sustainability. Since 1998, the "Putting the P.I.E.C.E.S. Together" learning initiative has been providing education sessions and related learning strategies aimed at developing the knowledge and skills of health professionals who care for older persons with complex physical and mental health needs and associated behaviors, in Ontario, Canada. A major focus of this province-wide initiative was the development of in-house Psychogeriatric Resource Persons (PRPs). Evaluation of this initiative included the completion of pre- and post-education questionnaires (over three data collection time periods) assessing learner confidence (N = 1,024 and 792, for pre- and post-education, respectively) and session evaluation questionnaires gathering feedback on the session (N = 2,029 across all sessions). A survey of LTC homes in Ontario (N = 439, 79% of the homes in the province) was conducted to assess longer-term sustainability. Ratings of the sessions indicated that they were relevant to learners' clinical practice. There were significant increases in ratings of ability to recognize and understand challenging behaviors and mental health problems, and in ability to use a variety of assessment tools. Few homes (15%) do not have a PRP; over 50% of the staff who completed the first session in 1999 continue to serve as a PRP and to apply learned skills. A learning initiative with supportive and reinforcing strategies can develop in-house PRPs to enhance the care of the elderly in LTC. Incorporation of PRP functions into job descriptions and management support contributed to the success of this initiative. This study highlights the importance of work environments that support and reinforce the use of learned skills to the success of continuing education and quality improvement initiatives in LTC.

Effects of internet-based cognitive behavioural therapy and physical exercise on sick leave and employment in primary care patients with depression: two subgroup analyses.

PubMed

Kaldo, Viktor; Lundin, Andreas; Hallgren, Mats; Kraepelien, Martin; Strid, Catharina; Ekblom, Örjan; Lavebratt, Catharina; Lindefors, Nils; Öjehagen, Agneta; Forsell, Yvonne

2018-01-01

Depression can negatively impact work capacity, but treatment effects on sick leave and employment are unclear. This study evaluates if internet-based cognitive behavioural therapy (ICBT) or physical exercise (PE), with already reported positive effects on clinical outcome and short-term work ability, has better effects on employment, sick leave and long-term work ability compared with treatment as usual (TAU) for depressed primary care patients (German clinical trials: DRKS00008745). After randomisation and exclusion of patients not relevant for work-related analysis, patients were divided into two subgroups: initially unemployed (total n=118) evaluated on employment, and employed (total n=703) evaluated on long-term sick leave. Secondary outcomes were self-rated work ability and average number of sick days per month evaluated for both subgroups. Assessments (self-reports) were made at baseline and follow-up at 3 and 12 months. For the initially unemployed subgroup, 52.6% were employed after 1 year (response rate 82%). Both PE (risk ratio (RR)=0.44; 95% CI 0.23 to 0.87) and ICBT (RR=0.37; 95% CI 0.16 to 0.84) showed lower rates compared with TAU after 3 months, but no difference was found after 1 year (PE: RR=0.97; 95% CI 0.69 to 1.57; ICBT: RR=1.23; 95% CI 0.72 to 2.13). For those with initial employment, long-term sick leave (response rate 75%) decreased from 7.8% to 6.5%, but neither PE (RR=1.4; 95% CI 0.52 to 3.74) nor ICBT (RR=0.99; 95% CI 0.39 to 2.46) decreased more than TAU, although a temporary positive effect for PE was found. All groups increased self-rated work ability with no differences found. No long-term effects were found for the initially unemployed on employment status or for the initially employed on sick leave. New types of interventions need to be explored. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Effect of a “Universal Antiretroviral Therapy” Recommendation on HIV RNA Levels Among HIV-Infected Patients Entering Care With a CD4 Count Greater Than 500/µL in a Public Health Setting

PubMed Central

Geng, Elvin H.; Hare, C. Bradley; Kahn, James O.; Jain, Vivek; Van Nunnery, Tracy; Christopoulos, Katerina A.; Deeks, Steven G.; Gandhi, Monica; Havlir, Diane V.

2012-01-01

Background. On 1 January 2010, a large, publicly funded clinic in San Francisco announced a “universal ART” approach to initiate antiretroviral therapy (ART) in all human immunodeficiency virus (HIV)-infected persons. The effect of changing guidance on real-world patient outcomes has not been evaluated. Methods. We evaluated untreated adult patients (defined as going >90 days without ART use) visiting clinic from 2001 to 2011. The cumulative incidence of HIV RNA suppression (viral load, <500 copies/mL), stratified by CD4 cell count at entry and calendar dates representing guideline issuance, were estimated using a competing risk framework. A multivariate Poisson-based model identified factors associated with HIV RNA suppression 6 months after clinic entry. Results. Of 2245 adults, 87% were male, and the median age was 39 years (interquartile range, 33–45 years). In 534 patients entering clinic with a CD4 cell count of >500 cells/µL, the 1-year incidence of HIV RNA suppression was 10.1% (95% confidence interval [CI], 6.6%–14.6%) before 4 April 2005; 9.1% (95% CI, 3.6%–17.4%) from 4 April 2005 to 1 December 2007; 14.1% (95% CI, 7.5%–22.8%) from 1 December 2007 to the universal ART recommendation and 52.8% (95% CI, 38.2%–65.4%) after. After adjustment, the SFGH policy was associated with a 6-fold increase in the probability of HIV RNA suppression 6 months after clinic entry. Conclusions. Recommendations to initiate ART in all HIV-infected patients increased the rate of HIV RNA suppression for patients enrolling in care with a CD4 cell count of >500 cells/µL and may foreshadow national trends given the March 2012 revision of national treatment guidelines to favor ART initiation for persons with CD4 cell counts of >500 cells/µL. PMID:22955429

Caring for individual patients and beyond: enhancing care through secondary use of data in a general practice setting.

PubMed

Tolar, Marianne; Balka, Ellen

2012-07-01

It is argued that with the introduction of electronic medical record (EMR) systems into the primary care sector, data collected can be used for secondary purposes which extend beyond individual patient care (e.g., for chronic disease management, prevention and clinical performance evaluation). However, EMR systems are primarily designed to support clinical tasks, and data entry practices of clinicians focus on the treatment of individual patients. Hence data collected through EMRs is not always useful in meeting these ends. In this paper we follow a community health centre (CHC), and document the changes in work practices of the personnel that were necessary in order to make EMR data useful for secondary purposes. This project followed an action research approach, in which ethnographic data were collected mainly by participant observations, by a researcher who also acted as an IT support person for the clinic's secondary usage of EMR data. Additionally, interviews were carried out with the clinical and administrative personnel of the CHC. The case study demonstrates that meaningful use of secondary data occurs only after a long process, aimed at creating the pre-conditions for meaningful use of secondary data, has taken place. PRECONDITIONS: Specific areas of focus have to be chosen for secondary data use, and initiatives have to be continuously evaluated and adapted to the workflow through a team approach. Collaboration between IT support and physicians is necessary to tailor the software to allow for the collection of clinically relevant data. Data entry procedures may have to be changed to encourage the usage of an agreed-upon coding scheme, required for meaningful use of secondary data. And finally resources in terms of additional personnel or dedicated time are necessary to keep up with data collection and other tasks required as a pre-condition to secondary use of data, communication of the results to the clinic, and eventual re-evaluation. Changes in the work practices observed in this case which were required to support secondary data use from the EMR included completion of additional tasks by clinical and administrative personnel related to the organization of follow-up tasks. Among physicians increased awareness of specific initiatives and guideline compliance in terms of chronic disease management and prevention was noticed. Finally, the clinic was able to evaluate their own practice and present the results to varied stakeholders. The case describes the secondary usage of data by a clinic aimed at improving management of the clinic's patients. It illustrates that creating the pre-conditions for secondary use of data from EMRs is a complex process which can be seen as a shift in paradigms from a focus on individual patient care to chronic disease management and performance measurement. More research is needed about how to best support clinics in the process of change management necessitated by emerging clinical management goals. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Evaluation of outcome and prognostic factors for dogs living greater than one year after diagnosis of osteosarcoma: 90 cases (1997-2008).

PubMed

Culp, William T N; Olea-Popelka, Francisco; Sefton, Jennifer; Aldridge, Charles F; Withrow, Stephen J; Lafferty, Mary H; Rebhun, Robert B; Kent, Michael S; Ehrhart, Nicole

2014-11-15

To evaluate clinical characteristics, outcome, and prognostic variables in a cohort of dogs surviving > 1 year after an initial diagnosis of osteosarcoma. Retrospective case series. 90 client-owned dogs. Medical records for an 11-year period from 1997 through 2008 were reviewed, and patients with appendicular osteosarcoma that lived > 1 year after initial histopathologic diagnosis were studied. Variables including signalment, weight, serum alkaline phosphatase activity, tumor location, surgery, and adjuvant therapies were recorded. Median survival times were calculated by means of a Kaplan-Meier survival function. Univariate analysis was conducted to compare the survival function for categorical variables, and the Cox proportional hazard model was used to evaluate the likelihood of death > 1 year after diagnosis on the basis of the selected risk factors. 90 dogs met the inclusion criteria; clinical laboratory information was not available in all cases. Median age was 8.2 years (range, 2.7 to 13.3 years), and median weight was 38 kg (83.6 lb; range, 21 to 80 kg [46.2 to 176 lb]). Serum alkaline phosphatase activity was high in 29 of 60 (48%) dogs. The most common tumor location was the distal portion of the radius (54/90 [60%]). Eighty-nine of 90 (99%) dogs underwent surgery, and 78 (87%) received chemotherapy. Overall, 49 of 90 (54%) dogs developed metastatic disease. The median survival time beyond 1 year was 243 days (range, 1 to 1,899 days). Dogs that developed a surgical-site infection after limb-sparing surgery had a significantly improved prognosis > 1 year after osteosarcoma diagnosis, compared with dogs that did not develop infections. Results of the present study indicated that dogs with an initial diagnosis of osteosarcoma that lived > 1 year had a median survival time beyond the initial year of approximately 8 months. As reported previously, the development of a surgical-site infection in dogs undergoing a limb-sparing surgery significantly affected prognosis and warrants further study.

eTACTS: a method for dynamically filtering clinical trial search results.

PubMed

Miotto, Riccardo; Jiang, Silis; Weng, Chunhua

2013-12-01

Information overload is a significant problem facing online clinical trial searchers. We present eTACTS, a novel interactive retrieval framework using common eligibility tags to dynamically filter clinical trial search results. eTACTS mines frequent eligibility tags from free-text clinical trial eligibility criteria and uses these tags for trial indexing. After an initial search, eTACTS presents to the user a tag cloud representing the current results. When the user selects a tag, eTACTS retains only those trials containing that tag in their eligibility criteria and generates a new cloud based on tag frequency and co-occurrences in the remaining trials. The user can then select a new tag or unselect a previous tag. The process iterates until a manageable number of trials is returned. We evaluated eTACTS in terms of filtering efficiency, diversity of the search results, and user eligibility to the filtered trials using both qualitative and quantitative methods. eTACTS (1) rapidly reduced search results from over a thousand trials to ten; (2) highlighted trials that are generally not top-ranked by conventional search engines; and (3) retrieved a greater number of suitable trials than existing search engines. eTACTS enables intuitive clinical trial searches by indexing eligibility criteria with effective tags. User evaluation was limited to one case study and a small group of evaluators due to the long duration of the experiment. Although a larger-scale evaluation could be conducted, this feasibility study demonstrated significant advantages of eTACTS over existing clinical trial search engines. A dynamic eligibility tag cloud can potentially enhance state-of-the-art clinical trial search engines by allowing intuitive and efficient filtering of the search result space. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

eTACTS: A Method for Dynamically Filtering Clinical Trial Search Results

PubMed Central

Miotto, Riccardo; Jiang, Silis; Weng, Chunhua

2013-01-01

Objective Information overload is a significant problem facing online clinical trial searchers. We present eTACTS, a novel interactive retrieval framework using common eligibility tags to dynamically filter clinical trial search results. Materials and Methods eTACTS mines frequent eligibility tags from free-text clinical trial eligibility criteria and uses these tags for trial indexing. After an initial search, eTACTS presents to the user a tag cloud representing the current results. When the user selects a tag, eTACTS retains only those trials containing that tag in their eligibility criteria and generates a new cloud based on tag frequency and co-occurrences in the remaining trials. The user can then select a new tag or unselect a previous tag. The process iterates until a manageable number of trials is returned. We evaluated eTACTS in terms of filtering efficiency, diversity of the search results, and user eligibility to the filtered trials using both qualitative and quantitative methods. Results eTACTS (1) rapidly reduced search results from over a thousand trials to ten; (2) highlighted trials that are generally not top-ranked by conventional search engines; and (3) retrieved a greater number of suitable trials than existing search engines. Discussion eTACTS enables intuitive clinical trial searches by indexing eligibility criteria with effective tags. User evaluation was limited to one case study and a small group of evaluators due to the long duration of the experiment. Although a larger-scale evaluation could be conducted, this feasibility study demonstrated significant advantages of eTACTS over existing clinical trial search engines. Conclusion A dynamic eligibility tag cloud can potentially enhance state-of-the-art clinical trial search engines by allowing intuitive and efficient filtering of the search result space. PMID:23916863

Validity and reliability of a novel measure of activity performance and participation.

PubMed

Murgatroyd, Phil; Karimi, Leila

2016-01-01

To develop and evaluate an innovative clinician-rated measure, which produces global numerical ratings of activity performance and participation. Repeated measures study with 48 community-dwelling participants investigating clinical sensibility, comprehensiveness, practicality, inter-rater reliability, responsiveness, sensitivity and concurrent validity with Barthel Index. Important clinimetric characteristics including comprehensiveness and ease of use were rated >8/10 by clinicians. Inter-rater reliability was excellent on the summary scores (intraclass correlation of 0.95-0.98). There was good evidence that the new outcome measure distinguished between known high and low functional scoring groups, including both responsiveness to change and sensitivity at the same time point in numerous tests. Concurrent validity with the Barthel Index was fair to high (Spearman Rank Order Correlation 0.32-0.85, p > 0.05). The new measure's summary scores were nearly twice as responsive to change compared with the Barthel Index. Other more detailed data could also be generated by the new measure. The Activity Performance Measure is an innovative outcome instrument that showed good clinimetric qualities in this initial study. Some of the results were strong, given the sample size, and further trial and evaluation is appropriate. Implications for Rehabilitation The Activity Performance Measure is an innovative outcome measure covering activity performance and participation. In an initial evaluation, it showed good clinimetric qualities including responsiveness to change, sensitivity, practicality, clinical sensibility, item coverage, inter-rater reliability and concurrent validity with the Barthel Index. Further trial and evaluation is appropriate.

Physiotherapy in hip and knee osteoarthritis: development of a practice guideline concerning initial assessment, treatment and evaluation.

PubMed

Peter, W F; Jansen, M J; Hurkmans, E J; Bloo, H; Dekker, J; Dilling, R G; Hilberdink, W; Kersten-Smit, C; de Rooij, M; Veenhof, C; Vermeulen, H M; de Vos, R J; Schoones, J W; Vliet Vlieland, T P

2011-01-01

An update of a Dutch physiotherapy practice guideline in Hip and Knee Osteoarthritis (HKOA) was made, based on current evidence and best practice. A guideline steering committee, comprising 10 expert physiotherapists, selected topics concerning the guideline chapters: initial assessment, treatment and evaluation. With respect to treatment a systematic literature search was performed using various databases, and the evidence was graded (1-4). For the initial assessment and evaluation mainly review papers and textbooks were used. Based on evidence and expert opinion, recommendations were formulated. A first draft of the guideline was reviewed by 17 experts from different professional backgrounds. A second draft was field-tested by 45 physiotherapists. In total 11 topics were selected. For the initial assessment, three recommendations were formulated, pertaining to history taking, red flags, and formulating treatment goals. Concerning treatment, 7 recommendations were formulated; (supervised) exercise therapy, education and self management interventions, a combination of exercise and manual therapy, postoperative exercise therapy and taping of the patella were recommended. Balneotherapy and hydrotherapy in HKOA, and thermotherapy, TENS, and Continuous Passive Motion in knee OA were neither recommended nor discouraged. Massage therapy, ultrasound, electrotherapy, electromagnetic field, Low Level Laser Therapy, preoperative physiotherapy and education could not be recommended. For the evaluation of treatment goals the following measurement instruments were recommended: Lequesne index, Western Ontario and McMaster Universities osteoarthritis index, Hip disability and Osteoarthritis Outcome Score and Knee injury and Osteoarthritis Outcome Score, 6-minute walktest, Timed Up and Go test, Patient Specific Complaint list, Visual Analoge Scale for pain, Intermittent and Constant OsteoArthritis Pain Questionnaire, goniometry, Medical Research Council for strength, handheld dynamometer. This update of a Dutch physiotherapy practice guideline on HKOA included 11 recommendations on the initial assessment, treatment and evaluation. The implementation of the guideline in clinical practice needs further evaluation.

A team-based approach to autopsy education: integrating anatomic and clinical pathology at the rotation level.

PubMed

Hébert, Tiffany Michele; Maleki, Sara; Vasovic, Ljiljana V; Arnold, Jeffrey L; Steinberg, Jacob J; Prystowsky, Michael B

2014-03-01

Pathology residency training programs should aim to teach residents to think beyond the compartmentalized data of specific rotations and synthesize data in order to understand the whole clinical picture when interacting with clinicians. To test a collaborative autopsy procedure at Montefiore Medical Center (Bronx, New York), linking residents and attending physicians from anatomic and clinical pathology in the autopsy process from the initial chart review to the final report. Residents consult with clinical pathology colleagues regarding key clinical laboratory findings during the autopsy. This new procedure serves multiple functions: creating a team-based, mutually beneficial educational experience; actively teaching consultative skills; and facilitating more in-depth analysis of the clinical laboratory findings in autopsies. An initial trial of the team-based autopsy system was done from November 2010 to December 2012. Residents were then surveyed via questionnaire to evaluate the frequency and perceived usefulness of clinical pathology autopsy consultations. Senior residents were the most frequent users of clinical pathology autopsy consultation. The most frequently consulted services were microbiology and chemistry. Eighty-nine percent of the residents found the clinical pathology consultation to be useful in arriving at a final diagnosis and clinicopathologic correlation. The team-based autopsy is a novel approach to integration of anatomic and clinical pathology curricula at the rotation level. Residents using this approach develop a more holistic approach to pathology, better preparing them for meaningful consultative interaction with clinicians. This paradigm shift in training positions us to better serve in our increasing role as arbiters of outcomes measures in accountable care organizations.

Challenges in Hospital-Associated Infection Management: A Unit Perspective.

PubMed

Stacy, Kathleen M

2015-01-01

Maintaining a successful unit-based continuous quality improvement program for managing hospital-associated infections is a huge challenge and an overwhelming task. It requires strong organizational support and unit leadership, human and fiscal resources, time, and a dedicated and motivated nursing staff. A great deal of effort goes into implementing, monitoring, reporting, and evaluating quality improvement initiatives and can lead to significant frustration on the part of the leadership team and nursing staff when quality improvement efforts fail to produce the desired results. Each initiative presents its own unique set of challenges; however, common issues influence all initiatives. These common issues include organization and unit culture, current clinical practice guidelines being used to drive the initiatives, performance discrepancies on the part of nursing staff, availability of resources including equipment and supplies, monitoring of the data, and conflicting quality improvement priorities.

Predicting inpatient clinical order patterns with probabilistic topic models vs conventional order sets.

PubMed

Chen, Jonathan H; Goldstein, Mary K; Asch, Steven M; Mackey, Lester; Altman, Russ B

2017-05-01

Build probabilistic topic model representations of hospital admissions processes and compare the ability of such models to predict clinical order patterns as compared to preconstructed order sets. The authors evaluated the first 24 hours of structured electronic health record data for > 10 K inpatients. Drawing an analogy between structured items (e.g., clinical orders) to words in a text document, the authors performed latent Dirichlet allocation probabilistic topic modeling. These topic models use initial clinical information to predict clinical orders for a separate validation set of > 4 K patients. The authors evaluated these topic model-based predictions vs existing human-authored order sets by area under the receiver operating characteristic curve, precision, and recall for subsequent clinical orders. Existing order sets predict clinical orders used within 24 hours with area under the receiver operating characteristic curve 0.81, precision 16%, and recall 35%. This can be improved to 0.90, 24%, and 47% ( P  < 10 -20 ) by using probabilistic topic models to summarize clinical data into up to 32 topics. Many of these latent topics yield natural clinical interpretations (e.g., "critical care," "pneumonia," "neurologic evaluation"). Existing order sets tend to provide nonspecific, process-oriented aid, with usability limitations impairing more precise, patient-focused support. Algorithmic summarization has the potential to breach this usability barrier by automatically inferring patient context, but with potential tradeoffs in interpretability. Probabilistic topic modeling provides an automated approach to detect thematic trends in patient care and generate decision support content. A potential use case finds related clinical orders for decision support. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Stem cells in clinical trials for treatment of retinal degeneration.

PubMed

Klassen, Henry

2016-01-01

After decades of basic science research involving the testing of regenerative strategies in animal models of retinal degenerative diseases, a number of clinical trials are now underway, with additional trials set to begin shortly. These efforts will evaluate the safety and preliminary efficacy of cell-based products in the eyes of patients with a number of retinal conditions, notably including age-related macular degeneration, retinitis pigmentosa and Stargardt's disease. This review considers the scientific work and early trials with fetal cells and tissues that set the stage for the current clinical investigatory work, as well the trials themselves, specifically those either now completed, underway or close to initiation. The cells of interest include retinal pigment epithelial cells derived from embryonic stem or induced pluripotent stem cells, undifferentiated neural or retinal progenitors or cells from the vascular/bone marrow compartment or umbilical cord tissue. Degenerative diseases of the retina represent a popular target for emerging cell-based therapeutics and initial data from early stage clinical trials suggest that short-term safety objectives can be met in at least some cases. The question of efficacy will require additional time and testing to be adequately resolved.

A continuous quality improvement approach to improving clinical practice in the areas of sedation, analgesia, and neuromuscular blockade.

PubMed

Arbour, Richard

2003-01-01

Practice concerns associated with the medical prescription and nurses' administration and monitoring of sedatives, analgesics, and neuromuscular blocking agents were identified by the clinical nurse specialist within a surgical intensive care unit of a large, tertiary-care referral center. These concerns were identified using a variety of needs assessment strategies. Results of the needs assessment were used to develop a program of care, including a teaching initiative, specific to these practice areas. The teaching initiative incorporated principles of andragogy, the theory of adult learning. Educational techniques included inservice education, bedside instruction using "teaching moments," competency-based education modules, and integration of instruction into critical care orientation. Content and approach were based on the background and level of experience of participants. Educational program outcomes included increased consistency in monitoring neuromuscular blockade by clinical assessment and peripheral nerve stimulation. A second outcome was more accurate patient assessment leading to the provision of drug therapy specific to the patients' clinical states, including anxiety or pain. The continuous quality improvement approach offers a model for improving patient care using individualized needs assessment, focused educational interventions, and program evaluation strategies.

Wells syndrome and its relationship to Churg-Strauss syndrome.

PubMed

Ratzinger, Gudrun; Zankl, Julia; Zelger, Bernhard

2013-08-01

  Wells syndrome has been described as an inflammatory disorder based on typical clinical appearance combined with the histopathological presence of eosinophilic infiltrates and flame figures in the absence of vasculitis. Churg-Strauss syndrome, on the other hand, is primarily a diffuse, necrotizing vasculitis but is also typically displaying eosinophils and flame figures. Despite several parallels, the present understanding of these two diseases excludes any pathogenetic relationship.   We describe the clinical course and histopathological appearance of three patients who had initially been diagnosed with Wells syndrome that developed into Churg-Strauss syndrome during the course of their disease.   The clinical presentation of all three patients led to the diagnosis of Wells syndrome by independent specialists. Histopathology showed an eosinophilic infiltrate and flame figures next to features of leukocytoclastic vasculitis. Detailed examination revealed asthma bronchiale and additional symptoms indicating Churg-Strauss syndrome. The initial diagnosis of Wells syndrome had to be revised to Churg-Strauss syndrome.   We conclude that Wells syndrome could be the starting point of a pathogenetic process that might reach its maximum in Churg-Strauss syndrome. As a clinical consequence, patients with Wells syndrome should be evaluated and followed for Churg-Strauss syndrome. © 2013 The International Society of Dermatology.

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.

Screening for latent tuberculous infection in people living with HIV infection in Auckland, New Zealand.

PubMed

Gow, N; Briggs, S; Nisbet, M

2017-09-01

New Zealand, which has a low incidence of tuberculosis (TB), has historically taken a risk-based approach to screening for latent tuberculous infection (LTBI) in adult people living with the human immunodeficiency virus infection (PLHIV). To evaluate LTBI screening, treatment and outcomes in an adult PLHIV population. This was a retrospective clinical record review of an initial cohort of adult PLHIV attending the Auckland City Hospital HIV clinic in 2011, and a second cohort of adult PLHIV newly attending the clinic in 2014. We analysed high-risk (born in or acquiring HIV in a high TB incidence country) and low-risk patients using descriptive statistical methods. Of the 752 patients from the initial cohort, 416 (55%) had documentation of LTBI screening, which was positive in 74 (10%): 19/461 (4%) low-risk and 55/291 (19%) high-risk patients. LTBI treatment was received in 13 low-risk and 44 high-risk patients. Of 73 patients in the second cohort, 68 (93%) were screened. LTBI screening was incomplete in our clinic, but improved between 2011 and 2014. A significant number of patients with LTBI did not originate from a high TB incidence country.

Fatigue as a Driver of Overall Quality of Life in Cancer Patients.

PubMed

McCabe, Ryan M; Grutsch, James F; Braun, Donald P; Nutakki, Swetha B

2015-01-01

This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain--a validated surrogate variable for overall cancer patient well-being. A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients' quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated.

Fatigue as a Driver of Overall Quality of Life in Cancer Patients

PubMed Central

McCabe, Ryan M.; Grutsch, James F.; Braun, Donald P.; Nutakki, Swetha B.

2015-01-01

Background This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain—a validated surrogate variable for overall cancer patient well-being. Methods A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Findings Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients’ quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. Interpretation By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated. PMID:26070133

Combining Time-Driven Activity-Based Costing with Clinical Outcome in Cost-Effectiveness Analysis to Measure Value in Treatment of Depression

PubMed Central

Lindefors, Nils

2016-01-01

Background A major challenge of mental health care is to provide safe and effective treatment with limited resources. The main purpose of this study was to examine a value-based approach in clinical psychiatry when evaluating a process improvement initiative. This was accomplished by using the relatively new time driven activity based costing (TDABC) method within the more widely adopted cost-effectiveness analysis framework for economic evaluation of healthcare technologies. The objective was to evaluate the cost-effectiveness of allowing psychologists to perform post-treatment assessment previously performed by psychiatrists at an outpatient clinic treating depression using internet-based cognitive-behavioral therapy (ICBT). Methods Data was collected from 568 adult patients treated with ICBT for depression during 2013–2014. The TDABC methodology was used to estimate total healthcare costs, including development of process maps for the complete cycle of care and estimation of resource use and minute costs of staff, hospital space and materials based on their relative proportions used. Clinical outcomes were measured using the Patient Health Questionnaire depression scale (PHQ-9) before and after treatment and at 6-month follow-up. Cost-effectiveness analyses (CEA) was performed and the results presented as incremental net benefits (INB), cost-effectiveness acceptability curves (CEACs) and confidence ellipses to demonstrate uncertainty around the value of the organizational intervention. Outcomes Taking into account the complete healthcare process (from referral to follow-up assessment), treatment costs decreased from $709 (SD = $130) per patient in 2013 to $659 (SD = $134) in 2014 while treatment effectiveness was maintained; 27% had achieved full remission from depression after treatment (PHQ-9 < 5) during both 2013 and 2014 and an additional 35% and 33% had achieved partial remission in 2013 and 2014, respectively. At follow-up, 42% were in full remission after treatment during both 2013 and 2014; an additional 35% and 33% were in partial remission during 2013 and 2014, respectively. Confidence ellipses occupied the south-east (SE) and south-west (SW) quadrants of the incremental cost-effectiveness plane at both post-treatment and at follow-up, indicating that the ICBT treatment was less costly and equally effective after staff reallocation. Conclusion Treating patients to the target of full remission using psychologists instead of medical specialists for post-treatment assessment is cost-saving and consequently a more valuable use of limited resources. TDABC may be a useful tool for measuring resource costs, identifying quality improvement opportunities and evaluating the consequences of such initiatives. Combining TDABC with clinical outcome measures in CEA is potentially a useful approach in mental healthcare to estimate the value of process improvement initiatives. PMID:27798655

Combining Time-Driven Activity-Based Costing with Clinical Outcome in Cost-Effectiveness Analysis to Measure Value in Treatment of Depression.

PubMed

El Alaoui, Samir; Lindefors, Nils

2016-01-01

A major challenge of mental health care is to provide safe and effective treatment with limited resources. The main purpose of this study was to examine a value-based approach in clinical psychiatry when evaluating a process improvement initiative. This was accomplished by using the relatively new time driven activity based costing (TDABC) method within the more widely adopted cost-effectiveness analysis framework for economic evaluation of healthcare technologies. The objective was to evaluate the cost-effectiveness of allowing psychologists to perform post-treatment assessment previously performed by psychiatrists at an outpatient clinic treating depression using internet-based cognitive-behavioral therapy (ICBT). Data was collected from 568 adult patients treated with ICBT for depression during 2013-2014. The TDABC methodology was used to estimate total healthcare costs, including development of process maps for the complete cycle of care and estimation of resource use and minute costs of staff, hospital space and materials based on their relative proportions used. Clinical outcomes were measured using the Patient Health Questionnaire depression scale (PHQ-9) before and after treatment and at 6-month follow-up. Cost-effectiveness analyses (CEA) was performed and the results presented as incremental net benefits (INB), cost-effectiveness acceptability curves (CEACs) and confidence ellipses to demonstrate uncertainty around the value of the organizational intervention. Taking into account the complete healthcare process (from referral to follow-up assessment), treatment costs decreased from $709 (SD = $130) per patient in 2013 to $659 (SD = $134) in 2014 while treatment effectiveness was maintained; 27% had achieved full remission from depression after treatment (PHQ-9 < 5) during both 2013 and 2014 and an additional 35% and 33% had achieved partial remission in 2013 and 2014, respectively. At follow-up, 42% were in full remission after treatment during both 2013 and 2014; an additional 35% and 33% were in partial remission during 2013 and 2014, respectively. Confidence ellipses occupied the south-east (SE) and south-west (SW) quadrants of the incremental cost-effectiveness plane at both post-treatment and at follow-up, indicating that the ICBT treatment was less costly and equally effective after staff reallocation. Treating patients to the target of full remission using psychologists instead of medical specialists for post-treatment assessment is cost-saving and consequently a more valuable use of limited resources. TDABC may be a useful tool for measuring resource costs, identifying quality improvement opportunities and evaluating the consequences of such initiatives. Combining TDABC with clinical outcome measures in CEA is potentially a useful approach in mental healthcare to estimate the value of process improvement initiatives.

A multiscale framework based on the physiome markup languages for exploring the initiation of osteoarthritis at the bone-cartilage interface.

PubMed

Shim, Vickie B; Hunter, Peter J; Pivonka, Peter; Fernandez, Justin W

2011-12-01

The initiation of osteoarthritis (OA) has been linked to the onset and progression of pathologic mechanisms at the cartilage-bone interface. Most importantly, this degenerative disease involves cross-talk between the cartilage and subchondral bone environments, so an informative model should contain the complete complex. In order to evaluate this process, we have developed a multiscale model using the open-source ontologies developed for the Physiome Project with cartilage and bone descriptions at the cellular, micro, and macro levels. In this way, we can effectively model the influence of whole body loadings at the macro level and the influence of bone organization and architecture at the micro level, and have cell level processes that determine bone and cartilage remodeling. Cell information is then passed up the spatial scales to modify micro architecture and provide a macro spatial characterization of cartilage inflammation. We evaluate the framework by linking a common knee injury (anterior cruciate ligament deficiency) to proinflammatory mediators as a possible pathway to initiate OA. This framework provides a "virtual bone-cartilage" tool for evaluating hypotheses, treatment effects, and disease onset to inform and strengthen clinical studies.

Passive sensor technology interface to assess elder activity in independent living.

PubMed

Alexander, Gregory L; Wakefield, Bonnie J; Rantz, Marilyn; Skubic, Marjorie; Aud, Myra A; Erdelez, Sanda; Ghenaimi, Said Al

2011-01-01

The effectiveness of clinical information systems to improve nursing and patient outcomes depends on human factors, including system usability, organizational workflow, and user satisfaction. The aim of this study was to examine to what extent residents, family members, and clinicians find a sensor data interface used to monitor elder activity levels usable and useful in an independent living setting. Three independent expert reviewers conducted an initial heuristic evaluation. Subsequently, 20 end users (5 residents, 5 family members, 5 registered nurses, and 5 physicians) participated in the evaluation. During the evaluation, each participant was asked to complete three scenarios taken from three residents. Morae recorder software was used to capture data during the user interactions. The heuristic evaluation resulted in 26 recommendations for interface improvement; these were classified under the headings content, aesthetic appeal, navigation, and architecture, which were derived from heuristic results. Total time for elderly residents to complete scenarios was much greater than for other users. Family members spent more time than clinicians but less time than residents did to complete scenarios. Elder residents and family members had difficulty interpreting clinical data and graphs, experienced information overload, and did not understand terminology. All users found the sensor data interface useful for identifying changing resident activities. Older adult users have special needs that should be addressed when designing clinical interfaces for them, especially information as important as health information. Evaluating human factors during user interactions with clinical information systems should be a requirement before implementation.

The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

PubMed

Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

2017-06-01

The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

Calories count. Improved weight gain with dietary intervention in congenital heart disease.

PubMed

Unger, R; DeKleermaeker, M; Gidding, S S; Christoffel, K K

1992-09-01

We assessed the nutritional status of patients with congenital heart disease (CHD) to evaluate the role of dietary intake in impaired weight for patient length. Underweight patients with CHD underwent nutritional counseling to evaluate the role of this intervention in improvement of weight for length. We prospectively evaluated a clinical protocol for nutritional assessment and counseling in patients with CHD. Eligible patients were enrolled from a cardiology clinic during a 13-month period. Initial anthropometric measurements and measurements of dietary intake of underweight and normal-weight patients were compared. Initial and follow-up measurements of underweight patients who received nutritional counseling were compared. Nineteen underweight patients with CHD and 16 normal-weight patients with CHD, aged 1 month to 2 years, were studied. Exclusion criteria included noncardiac factors that could affect growth (eg, low birth weight, Down syndrome, gastrointestinal deficit, and any severe abnormality of the central nervous system). Seventeen of the 19 underweight patients underwent nutritional counseling in the presence of a parent every 2 months for 6 months. Caloric and protein intakes were maximized using high-calorie formulas. Baseline dietary intake was lower in underweight patients than in normal-weight patients (mean percentage of the recommended daily allowance of calories, 89% vs 108%). Follow-up evaluation in normal-weight patients showed no change in percentage of ideal body weight for length. Follow-up evaluation in underweight patients showed improvement in mean dietary intake (from 90% to 104% of the recommended daily allowance of calories) and in mean percentage of ideal body weight for length after intervention (from 83.1% to 88.3%). Nutritional evaluation of patients with CHD demonstrated that underweight children had inadequate diets. Underweight patients with CHD who received nutritional counseling showed increased dietary intake and improved anthropometric measurements on follow-up.

Quadruple inversion-recovery b-SSFP MRA of the abdomen: initial clinical validation.

PubMed

Atanasova, Iliyana P; Lim, Ruth P; Chandarana, Hersh; Storey, Pippa; Bruno, Mary T; Kim, Daniel; Lee, Vivian S

2014-09-01

The purpose of this study is to assess the image quality and diagnostic accuracy of non-contrast quadruple inversion-recovery balanced-SSFP MRA (QIR MRA) for detection of aortoiliac disease in a clinical population. QIR MRA was performed in 26 patients referred for routine clinical gadolinium-enhanced MRA (Gd-MRA) for known or suspected aortoiliac disease. Non-contrast images were independently evaluated for image quality and degree of stenosis by two radiologists, using consensus Gd-MRA as the reference standard. Hemodynamically significant stenosis (≥50%) was found in 10% (22/226) of all evaluable segments on Gd-MRA. The sensitivity and specificity for stenosis evaluation by QIR MRA for the two readers were 86%/86% and 95%/93% respectively. Negative predictive value and positive predictive value were 98%/98% and 63%/53% respectively. For stenosis evaluation of the aortoiliac region QIR MRA showed good agreement with the reference standard with high negative predictive value and a tendency to overestimate mild disease presumably due to the flow-dependence of the technique. QIR MRA could be a reasonable alternative to Gd-MRA for ruling out stenosis when contrast is contraindicated due to impaired kidney function or in patients who undergo abdominal MRA for screening purposes. Further work is necessary to improve performance and justify routine clinical use. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Trends in referral to a single encopresis clinic over 20 years.

PubMed

Fishman, Laurie; Rappaport, Leonard; Schonwald, Alison; Nurko, Samuel

2003-05-01

To compare the characteristics of children with encopresis referred to a single encopresis clinic over the course of 20 years, including symptoms, previous diagnostic and therapeutic interventions, and parental attitudes. A retrospective study was conducted of an encopresis clinic at a tertiary care pediatric hospital. Questionnaires at initial evaluation elicited information about bowel habits, soiling, previous evaluations, previous treatments, and parental attitudes. In 503 children with encopresis, the average age of referral dropped from 115 months during the earliest 5 years to 77 months during the most recent 5 years. Children who had soiling for >3 years before referral decreased from 63% to 12%. The use of barium enema before referral decreased from 14% to 5%, as did psychological evaluation, from 25% to 14%. Previous therapy with enemas decreased from 45% to 27%. Mineral oil use remained at approximately 50%, and 20% of children had no previous treatment. Symptoms at referral and parental attitudes did not change across the years. Children are now referred at an earlier age to our tertiary encopresis clinic. The number of invasive and psychological evaluations has decreased before referral. However, treatment by many primary care providers before the referral has not changed. These data may suggest that pediatricians have increased awareness of encopresis and greater appreciation of its primarily physical rather than psychological nature. Additional studies will be needed to determine how these factors affect outcome.

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.

A European perspective--the European clinical research infrastructures network.

PubMed

Demotes-Mainard, J; Kubiak, C

2011-11-01

Evaluating research outcomes requires multinational cooperation in clinical research for optimization of treatment strategies and comparative effectiveness research, leading to evidence-based practice and healthcare cost containment. The European Clinical Research Infrastructures Network (ECRIN) is a distributed ESFRI (European Strategy Forum on Research Infrastructures) roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific potential. Servicing multinational trials started during its preparatory phase, and ECRIN will now apply for an ERIC (European Research Infrastructures Consortium) status by 2011. By creating a single area for clinical research in Europe, this achievement will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of the research and education capacity, tackling the major societal challenges starting with the area of healthy ageing, and removing barriers to bring ideas to the market.

Outcomes of a Clinic-Based, Surveillance-Informed Intervention to Relink Patients to HIV Care

PubMed Central

Bove, Joanna; Golden, Matthew R.; Dhanireddy, Shireesha; Harrington, Robert D.; Dombrowski, Julia C.

2015-01-01

Background Improving patient retention in HIV care is crucial to improving the HIV care continuum. We instituted and evaluated a relinkage program that uses clinical data to identify potentially out-of-care patients, matches those data to public health surveillance, and employs a linkage specialist (LS) to coordinate care relinkage. Methods The intervention began November 1, 2012 in the largest HIV clinic in Washington State. We evaluated program outcomes and compared patient outcomes in the year following initiation of the intervention to a historical control cohort of patients. Cox proportional hazard ratios were used to compare time to relinkage to care between cohorts, and regression models using generalized estimated equations were preformed to examine secondary outcomes of relinkage to care, engagement in care, and viral suppression. Results 753 patients were identified as “out of care” on 11/1/12. Matching with surveillance data and initial LS investigations found that 596 (79%) of these patients had moved, transferred care or were incarcerated. Of the 157 remaining patients: 40 (25%) relinked to care before LS contact, and the LS successfully contacted 38 (24%). A total of 116 (15%) patients in the intervention cohort relinked to care and 24 (20%) were contacted by the LS. Compared to the historical cohort, the time to relinkage was shorter among patients in the intervention cohort [adjusted HR=1.7 (1.2-2.3)] and a greater proportion relinked [15% vs. 10%]. Conclusions This clinic-based, surveillance-informed relinkage intervention showed statistically significant but modest effectiveness in returning out-of-care patients to HIV care compared to historical controls. PMID:26068720

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.

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].

Risk of fever and sepsis evaluations after routine immunizations in the neonatal intensive care unit.

PubMed

Navar-Boggan, A M; Halsey, N A; Golden, W C; Escobar, G J; Massolo, M; Klein, N P

2010-09-01

Premature infants can experience cardiorespiratory events such as apnea after immunization in the neonatal intensive care unit (NICU). These changes in clinical status may precipitate sepsis evaluations. This study evaluated whether sepsis evaluations are increased after immunizations in the NICU. We conducted a retrospective cohort study of infants older than 53 days who were vaccinated in the NICU at the KPMCP (Kaiser Permanente Medical Care Program). Chart reviews were carried out before and after all immunizations were administered and for all sepsis evaluations after age 53 days. The clinical characteristics of infants on the day before receiving a sepsis evaluation were compared between children undergoing post-immunization sepsis evaluations and children undergoing sepsis evaluation at other times. The incidence rate of sepsis evaluations in the post-immunization period was compared with the rate in a control time period not following immunization using Poisson regression. A total of 490 infants met the inclusion criteria. The rate of fever was increased in the 24 h period after vaccination (2.3%, P<0.05). The incidence rate of sepsis evaluations was 40% lower after immunization than during the control period, although this was not statistically significant (P=0.09). Infants undergoing a sepsis evaluation after immunization were more likely to have an apneic, bradycardic or moderate-to-severe cardiorespiratory event in the day before the evaluation than were infants undergoing sepsis evaluations at other times (P<0.05). Despite an increase in fever and cardiorespiratory events after immunization in the NICU, routine vaccination was not associated with increased risk of receiving sepsis evaluations. Providers may be deferring immunizations until infants are clinically stable, or may have a higher threshold for initiating sepsis evaluations after immunization than at other times.

The Female Pattern Hair Loss: Review of Etiopathogenesis and Diagnosis

PubMed Central

Vujovic, Anja; Del Marmol, Véronique

2014-01-01

Female pattern hair loss (FPHL) is the most common hair loss disorder in women. Initial signs may develop during teenage years leading to a progressive hair loss with a characteristic pattern distribution. The condition is characterized by progressive replacement of terminal hair follicles over the frontal and vertex regions by miniaturized follicles, that leads progressively to a visible reduction in hair density. Women diagnosed with FPHL may undergo significant impairment of quality of life. FPHL diagnosis is mostly clinical. Depending on patient history and clinical evaluation, further diagnostic testing may be useful. The purpose of the paper is to review the current knowledge about epidemiology, pathogenesis, clinical manifestations, and diagnosis of FPHL. PMID:24812631

Healthcare provider education to support integration of pharmacogenomics in practice: the eMERGE Network experience

PubMed Central

Rohrer Vitek, Carolyn R; Abul-Husn, Noura S; Connolly, John J; Hartzler, Andrea L; Kitchner, Terrie; Peterson, Josh F; Rasmussen, Luke V; Smith, Maureen E; Stallings, Sarah; Williams, Marc S; Wolf, Wendy A; Prows, Cynthia A

2017-01-01

Ten organizations within the Electronic Medical Records and Genomics Network developed programs to implement pharmacogenomic sequencing and clinical decision support into clinical settings. Recognizing the importance of informed prescribers, a variety of strategies were used to incorporate provider education to support implementation. Education experiences with pharmacogenomics are described within the context of each organization's prior involvement, including the scope and scale of implementation specific to their Electronic Medical Records and Genomics projects. We describe common and distinct education strategies, provide exemplars and share challenges. Lessons learned inform future perspectives. Future pharmacogenomics clinical implementation initiatives need to include funding toward implementing provider education and evaluating outcomes. PMID:28639489

Clinical audit in dentistry: From a concept to an initiation

PubMed Central

Malleshi, Suchetha N; Joshi, Mahasweta; Nair, Soumya K; Ashraf, Irshad

2012-01-01

Clinical audit is a quality improvement process that aims to improve patient care through a systematic review of care against explicit criteria. It is a cyclic and multidisciplinary process which involves a series of steps from planning the audit through measuring the performance to implementing and sustaining the change. Although audit contains some facets of research, it is essential to understand the difference between the two. Auditing can be done right from the record maintaining, diagnosis and treatment and postoperative evaluation and follow-up. The immense potential of clinical audit can be utilized only when open-mindedness and innovativeness are encouraged and evidence-based work culture is cultivated. PMID:23559939

Computed tomography in the evaluation of Crohn disease

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

Goldberg, H.I.; Gore, R.M.; Margulis, A.R.

1983-02-01

The abdominal and pelvic computed tomographic examinations in 28 patients with Crohn disease were analyzed and correlated with conventional barium studies, sinograms, and surgical findings. Mucosal abnormalities such as aphthous lesions, pseudopolyps, and ulcerations were only imaged by conventional techniques. Computed tomography proved superior in demonstrating the mural, serosal, and mesenteric abnormalities such as bowel wall thickening (82%), fibrofatty proliferation of mesenteric fat (39%), mesenteric abscess (25%), inflammatory reaction of the mesentery (14%), and mesenteric lymphadenopathy (18%). Computed tomography was most useful clinically in defining the nature of mass effects, separation, or displacement of small bowel segments seen on smallmore » bowel series. Although conventional barium studies remain the initial diagnostic procedure in evaluating Crohn disease, computed tomography can be a useful adjunct in resolving difficult clinical and radiologic diagnostic problems.« less

MDPHnet: Secure, Distributed Sharing of Electronic Health Record Data for Public Health Surveillance, Evaluation, and Planning

PubMed Central

Vogel, Joshua; Brown, Jeffrey S.; Land, Thomas; Platt, Richard

2014-01-01

Electronic health record systems contain clinically detailed data from large populations of patients that could significantly enrich public health surveillance. Clinical practices’ security, privacy, and proprietary concerns, however, have limited their willingness to share these data with public health agencies. We describe a novel distributed network for public health surveillance called MDPHnet. The system allows the Massachusetts Department of Public Health (MDPH) to initiate custom queries against participating practices’ electronic health records while the data remain behind each practice’s firewall. Practices can review proposed queries before execution and approve query results before releasing them to the health department. MDPH is using the system for routine surveillance for priority conditions and to evaluate the impact of public health interventions. PMID:25322301

United Kingdom immune thrombocytopenia registry: retrospective evaluation of bone marrow fibrosis in adult patients with primary immune thrombocytopenia and correlation with clinical findings.

PubMed

Rizvi, Hasan; Butler, Tom; Calaminici, Mariarita; Doobaree, Indraraj U; Nandigam, Raghava C; Bennett, Dimitri; Provan, Drew; Newland, Adrian C

2015-05-01

Fibrosis has been reported in some patients with immune thrombocytopenia (ITP) treated with thrombopoietin receptor agonists (TPO-RA). However, fibrosis has also been reported in patients with various stages of ITP, who were TPO-RA treatment-naïve. In our study, we looked for fibrosis in bone marrow trephine biopsies taken at initial diagnosis from 32 adult patients with ITP. Ten of the 32 evaluated samples (31·25%) showed increased reticulin (Grade 1-2 on Bauermeister scale and Grade 0-1 on the European Consensus scale), which showed a positive correlation with ethnicity (0·3%) but did not correlate with disease severity, any clinical features or co-morbidities. © 2015 John Wiley & Sons Ltd.

Identification and management of eating disorders in children and adolescents.

PubMed

Rosen, David S

2010-12-01

The incidence and prevalence of eating disorders in children and adolescents has increased significantly in recent decades, making it essential for pediatricians to consider these disorders in appropriate clinical settings, to evaluate patients suspected of having these disorders, and to manage (or refer) patients in whom eating disorders are diagnosed. This clinical report includes a discussion of diagnostic criteria and outlines the initial evaluation of the patient with disordered eating. Medical complications of eating disorders may affect any organ system, and careful monitoring for these complications is required. The range of treatment options, including pharmacotherapy, is described in this report. Pediatricians are encouraged to advocate for legislation and policies that ensure appropriate services for patients with eating disorders, including medical care, nutritional intervention, mental health treatment, and care coordination.

Ambulatory Assessment of Depression in Primary Care

DTIC Science & Technology

2016-06-29

activities (anhedonia) for over 2 weeks, plus at least four of the following symptoms: changes in sleep, changes in appetite or weight, fatigue, change...such as pain are the initial presenting symptoms of patients who are subsequently diagnosed with depression in a family practice clinic. Somatic...authors concluded that general practitioners should carefully evaluate medically unexplained physical symptoms. These symptoms included back pain